1 00:00:05,360 --> 00:00:10,000 WELCOME EVERYBODY TO THE BRAIN 2 00:00:10,000 --> 00:00:15,680 NEWG WITH THE CONTINUING TRIAL 3 00:00:15,680 --> 00:00:20,040 RESPONSIBILITIES. 4 00:00:20,040 --> 00:00:22,600 FROM THE DIRECTOR OF THE NIH 5 00:00:22,600 --> 00:00:23,120 BRAIN INITIATIVE I WANT TO 6 00:00:23,120 --> 00:00:23,720 THANK EVERYBODY WHO MADE THIS 7 00:00:23,720 --> 00:00:24,960 WORKSHOP HAPPEN. 8 00:00:24,960 --> 00:00:30,640 STARTING WITH CHRISTINE AND 9 00:00:30,640 --> 00:00:31,240 THE COCHAIRS NEWG AND THE REST 10 00:00:31,240 --> 00:00:33,120 OF THE NEWG MEMBERS AND THE 11 00:00:33,120 --> 00:00:35,080 STAFF AT NIH WHO ARE FOCUSED 12 00:00:35,080 --> 00:00:35,640 AND DEDICATED TO ADDRESSING 13 00:00:35,640 --> 00:00:40,760 THESE ISSUES OF NEURAL ETHICS 14 00:00:40,760 --> 00:00:46,360 AND WITH ALL THE WORK TO PUT 15 00:00:46,360 --> 00:00:46,680 THIS TOGETHER. 16 00:00:46,680 --> 00:00:47,160 WE ARE EXCITED TO BRING 17 00:00:47,160 --> 00:00:50,480 TOGETHER COMMUNITIES. 18 00:00:50,480 --> 00:00:51,040 BUT WE ARE MOTIVATED BY THAT 19 00:00:51,040 --> 00:00:53,360 COLLECTIVE SUGGESTION FROM 20 00:00:53,360 --> 00:00:58,240 PEOPLE FROM DIFFERENT DOMAINS. 21 00:00:58,240 --> 00:01:05,840 VERY IMPORTANTLY ARE THE HUMAN 22 00:01:05,840 --> 00:01:10,760 PARTICIPANTS WE REALLY DO SEE 23 00:01:10,760 --> 00:01:11,320 THE NEED TO LOOK AT A SHARED 24 00:01:11,320 --> 00:01:17,160 RESPONSIBILITY TO FACILITATE 25 00:01:17,160 --> 00:01:17,720 RESEARCH RELATED CARE AFTER 26 00:01:17,720 --> 00:01:18,280 THE TRIAL FORMALLY ENDS BUT 27 00:01:18,280 --> 00:01:18,880 QUITE HONESTLY IT'S NOT CLEAR 28 00:01:18,880 --> 00:01:21,280 HOW TO MAKE THIS HAPPEN HOW WE 29 00:01:21,280 --> 00:01:23,480 SPECIFY OR OPERATIONALIZE WHAT 30 00:01:23,480 --> 00:01:31,320 NEEDS TO BE DONE IN REALITY. 31 00:01:31,320 --> 00:01:31,920 SO THE WORKSHOP IS STRUCTURED 32 00:01:31,920 --> 00:01:32,440 THROUGH A SERIES OF FOUR 33 00:01:32,440 --> 00:01:32,640 PANELS. 34 00:01:32,640 --> 00:01:34,040 TODAY WE WILL START WITH THE 35 00:01:34,040 --> 00:01:37,320 FIRST TWO. 36 00:01:37,320 --> 00:01:37,880 WE WILL START WITH THE PANEL 37 00:01:37,880 --> 00:01:38,480 RIGHT AFTER THIS TO EXPLORE 38 00:01:38,480 --> 00:01:40,080 THE NEEDS THE STUDY 39 00:01:40,080 --> 00:01:44,520 PARTICIPANTS HAVE IN RELATION. 40 00:01:44,520 --> 00:01:47,040 THE SECOND PANEL OF THE 41 00:01:47,040 --> 00:01:49,920 AFTERNOON ABOUT THE 42 00:01:49,920 --> 00:01:50,520 STAKEHOLDERS CURRENTLY PROVIDE 43 00:01:50,520 --> 00:01:51,360 AND WHAT IS IN THE REALM OF 44 00:01:51,360 --> 00:01:53,720 POSSIBILITIES FOR WHAT THEY 45 00:01:53,720 --> 00:01:56,040 COULD FACILITATE FOR RESEARCH 46 00:01:56,040 --> 00:01:57,440 CARE. 47 00:01:57,440 --> 00:01:57,960 TOMORROW WE CONTINUE THE 48 00:01:57,960 --> 00:01:58,520 CONVERSATION AND THE THIRD 49 00:01:58,520 --> 00:02:01,200 PANEL SEEK PERSPECTIVES AT A 50 00:02:01,200 --> 00:02:06,440 REASONABLE LEVEL THAT IS 51 00:02:06,440 --> 00:02:09,040 ASSOCIATED AND THEN THE LAST 52 00:02:09,040 --> 00:02:10,280 SESSION WILL FOCUS ON THE 53 00:02:10,280 --> 00:02:16,560 UNMET NEEDS AND HOW IT CAN 54 00:02:16,560 --> 00:02:17,160 FILL THOSE AND HOW I'M LOOKING 55 00:02:17,160 --> 00:02:17,920 FORWARD TO EVERYBODY'S 56 00:02:17,920 --> 00:02:23,360 PARTICIPATION LEVEL TODAY AND 57 00:02:23,360 --> 00:02:24,720 TOMORROW IT WILL HAVE THE 58 00:02:24,720 --> 00:02:32,920 REASONABLE EXPECTATIONS THAT 59 00:02:32,920 --> 00:02:33,480 COULD INFORM GUIDELINES AND 60 00:02:33,480 --> 00:02:33,840 BEST PRACTICES. 61 00:02:33,840 --> 00:02:34,440 THANK YOU FOR BEING HERE THESE 62 00:02:34,440 --> 00:02:38,400 ARE TOUGH QUESTIONS WE ARE 63 00:02:38,400 --> 00:02:39,000 ASKING NOT THE LEAST OF WHICH 64 00:02:39,000 --> 00:02:40,520 OF HOW TO MAKE THINGS HAPPEN 65 00:02:40,520 --> 00:02:41,040 AFTER WE DECIDE WHAT MIGHT 66 00:02:41,040 --> 00:02:44,400 NEED TO HAPPEN AND THEN WILL 67 00:02:44,400 --> 00:02:46,480 DISCUSS THE INTRODUCTION OF 68 00:02:46,480 --> 00:02:48,040 BACKGROUND. 69 00:02:48,040 --> 00:02:58,280 >> THANK YOU. 70 00:03:00,200 --> 00:03:00,640 I WILL START WITH QUICK 71 00:03:00,640 --> 00:03:05,160 INTRODUCTION AND BACKGROUND SO 72 00:03:05,160 --> 00:03:05,760 WE'RE ON THE SAME PAGE FOR THE 73 00:03:05,760 --> 00:03:11,840 REST OF THE WORKSHOP. 74 00:03:11,840 --> 00:03:12,400 FIRST LET ME SPEAK TO WHY WE 75 00:03:12,400 --> 00:03:13,000 NEED THE SCIENCE THAT IS 76 00:03:13,000 --> 00:03:18,200 RELEVANT TODAY DISORDERS CAUSE 77 00:03:18,200 --> 00:03:18,760 A HIGH BURDEN OF DISEASE IN 78 00:03:18,760 --> 00:03:21,040 THE US AND WORLDWIDE THAT 79 00:03:21,040 --> 00:03:22,720 EXCITING PERIOD OF 80 00:03:22,720 --> 00:03:28,160 NEUROSCIENCE THAT SCIENTIST 81 00:03:28,160 --> 00:03:29,200 HAVE DEVICES TO TRACK THESE 82 00:03:29,200 --> 00:03:30,160 CONDITIONS. 83 00:03:30,160 --> 00:03:38,640 HOWEVER THE DEVELOPMENT OF 84 00:03:38,640 --> 00:03:39,160 THEM TO BE USED ON HUMAN 85 00:03:39,160 --> 00:03:39,400 SUBJECTS. 86 00:03:39,400 --> 00:03:40,000 WE CANNOT ADVANCE THE FIELD 87 00:03:40,000 --> 00:03:40,440 WITHOUT THE GENEROUS 88 00:03:40,440 --> 00:03:41,760 CONTRIBUTION THAT PATIENTS 89 00:03:41,760 --> 00:03:44,680 MAKE ON TIFFANY'S TRIALS. 90 00:03:44,680 --> 00:03:47,200 IT IS WORTH NOTING THESE ARE 91 00:03:47,200 --> 00:03:51,320 PATIENTS THEY FOUND THEIR 92 00:03:51,320 --> 00:03:53,640 TREATMENT RESISTANT MAY NOT 93 00:03:53,640 --> 00:03:58,840 HAVE OTHER OPTIONS THEY MAY OR 94 00:03:58,840 --> 00:03:59,400 MAY NOT HELP THESE PATIENTS 95 00:03:59,400 --> 00:04:00,000 THEY CONTRIBUTE TO THESE 96 00:04:00,000 --> 00:04:03,520 TRIALS SO IT IS IMPERATIVE WE 97 00:04:03,520 --> 00:04:09,040 HAVE HIGH ETHICAL STANDARDS. 98 00:04:09,040 --> 00:04:11,920 THIS WORKSHOP IS RELATED TO 99 00:04:11,920 --> 00:04:14,400 THAT GENERAL GOAL OF NIH. 100 00:04:14,400 --> 00:04:20,040 SO SPECIFICALLY WE WILL GET 101 00:04:20,040 --> 00:04:20,600 THE NEEDS THAT PATIENTS MAY 102 00:04:20,600 --> 00:04:24,480 HAVE AFTER THE TRIAL HAS ENDED 103 00:04:24,480 --> 00:04:25,480 WE ARE LOOKING AT RESEARCH 104 00:04:25,480 --> 00:04:29,840 RELATED NEEDS TO THE DEVICE 105 00:04:29,840 --> 00:04:30,400 THAT WAS IMPLANTED AFTER THE 106 00:04:30,400 --> 00:04:31,960 TRIAL HAS ENDED FOR EXAMPLE 107 00:04:31,960 --> 00:04:36,120 PATIENTS MAY USE EXPERIENCE 108 00:04:36,120 --> 00:04:39,360 BENEFITS FROM THE DEVICE AND 109 00:04:39,360 --> 00:04:39,920 THEN THEY WANT TO KEEP IT 110 00:04:39,920 --> 00:04:46,000 AFTER THE TRIAL ENDS. 111 00:04:46,000 --> 00:04:46,600 AND THEN THEY NEED MAINTENANCE 112 00:04:46,600 --> 00:04:48,400 LIKE REPLACING BATTERIES OR 113 00:04:48,400 --> 00:04:56,760 THE EXPECTATION. 114 00:04:56,760 --> 00:04:57,360 SO WITH OTHER DEVICE TRIALS IN 115 00:04:57,360 --> 00:04:57,920 THE NEEDS THAT PATIENTS HAVE 116 00:04:57,920 --> 00:04:58,840 RELATED TO THE TRIALS AFTER 117 00:04:58,840 --> 00:05:04,000 THE TRIAL HAS ENDED. 118 00:05:04,000 --> 00:05:06,920 SO THE CLASSIC SCENARIO IS 119 00:05:06,920 --> 00:05:09,360 ONCE THE TRIAL HAS ENDED BUT 120 00:05:09,360 --> 00:05:11,240 BEFORE IT HAS BEEN APPROVED 121 00:05:11,240 --> 00:05:14,760 FOR CLINICAL USE OF THOSE 122 00:05:14,760 --> 00:05:18,560 SCENARIOS ARE POSSIBLE IF THE 123 00:05:18,560 --> 00:05:22,360 TRIAL DISCONTINUES PREMATURELY 124 00:05:22,360 --> 00:05:22,960 BY THERE IS NO REGULATORY ROLE 125 00:05:22,960 --> 00:05:28,800 FOR THE DEVICE THOSE FORMER 126 00:05:28,800 --> 00:05:29,320 PARTICIPANTS MAY NOT HAVE 127 00:05:29,320 --> 00:05:30,160 COVERAGE OPTIONS WITH THEIR 128 00:05:30,160 --> 00:05:33,800 INSURANCE OR IF AT ANY POINT 129 00:05:33,800 --> 00:05:35,760 IN TIME MAY DISCONTINUE THE 130 00:05:35,760 --> 00:05:37,520 PRODUCT SO I WENT TO HIGHLIGHT 131 00:05:37,520 --> 00:05:41,640 THE CLASSIC SCENARIO IS 132 00:05:41,640 --> 00:05:47,000 TIME-LIMITED THAT AT LAST 133 00:05:47,000 --> 00:05:48,720 UNTIL IT IS APPROVED. 134 00:05:48,720 --> 00:05:56,760 IT MAY LAST LONGER SO SEVERAL 135 00:05:56,760 --> 00:06:01,520 REASONS HAVE BEEN EXPRESSED BY 136 00:06:01,520 --> 00:06:02,040 OTHERS INVOLVED IN THESE 137 00:06:02,040 --> 00:06:03,040 TRIALS MAY HAVE 138 00:06:03,040 --> 00:06:04,640 RESPONSIBILITIES OF ATTENDING 139 00:06:04,640 --> 00:06:08,920 TO THESE NEEDS SO IF YOU ARE 140 00:06:08,920 --> 00:06:12,240 PROFESSIONAL STAKEHOLDER TO 141 00:06:12,240 --> 00:06:14,880 RECEIVE AN EXTRA RENTAL DEVICE 142 00:06:14,880 --> 00:06:18,560 YOU RESPONSIBILITY FOR HELPING 143 00:06:18,560 --> 00:06:20,120 PARENTS TO HARM OF THOSE 144 00:06:20,120 --> 00:06:24,280 INDIVIDUALS WE ALSO HAVE 145 00:06:24,280 --> 00:06:25,120 RESPONSIBILITY TO HELP ADVANCE 146 00:06:25,120 --> 00:06:30,840 PATIENTS INTEREST AND WHILE 147 00:06:30,840 --> 00:06:35,720 OVER TIME THEY DON'T 148 00:06:35,720 --> 00:06:36,280 NECESSARILY STOP AT THE TIME 149 00:06:36,280 --> 00:06:38,720 THE TRIAL ENDS. 150 00:06:38,720 --> 00:06:49,240 IT'S OFTEN REGARDED AND SECOND 151 00:06:50,600 --> 00:06:57,720 AND WITH THAT RECIPROCITY AND 152 00:06:57,720 --> 00:06:58,320 WITH THOSE RISK THEY UNDERTAKE 153 00:06:58,320 --> 00:07:05,200 AS PARTICIPANTS SO FOR EXAMPLE 154 00:07:05,200 --> 00:07:07,000 OF THIS RESEARCH PARTICIPANT 155 00:07:07,000 --> 00:07:13,000 EXPRESSED IT FELT LIKE HE LUCK 156 00:07:13,000 --> 00:07:13,520 IF I IMPLANT THINGS IN MY 157 00:07:13,520 --> 00:07:14,080 BRAIN AND I'M WALKING AROUND 158 00:07:14,080 --> 00:07:16,320 WITH THIS YOU HAVE A 159 00:07:16,320 --> 00:07:20,320 RESPONSIBILITY TO LOOK AFTER 160 00:07:20,320 --> 00:07:22,880 ME. 161 00:07:22,880 --> 00:07:33,160 AND THIRD BUT ALTHOUGH MANY AS 162 00:07:33,160 --> 00:07:38,760 A MEANS TO AN END AND THEN 163 00:07:38,760 --> 00:07:42,400 WITH THE CONCERNS OF THE X PER 164 00:07:42,400 --> 00:07:45,640 AND WITH THAT RELATIONSHIP 165 00:07:45,640 --> 00:07:46,200 BETWEEN THE PARTICIPANTS AND 166 00:07:46,200 --> 00:07:49,600 THOSE INVOLVED IN THE TRIAL 167 00:07:49,600 --> 00:07:55,040 HAS SOME TYPES OF RELATIONAL 168 00:07:55,040 --> 00:08:01,360 DUTIES. 169 00:08:01,360 --> 00:08:01,760 WITH THAT POSTTRIAL 170 00:08:01,760 --> 00:08:04,600 RESPONSIBILITIES HAVE LIMITS 171 00:08:04,600 --> 00:08:11,040 AND OPPORTUNITY COSTS 172 00:08:11,040 --> 00:08:13,240 STAKEHOLDERS ALSO HAVE 173 00:08:13,240 --> 00:08:15,160 IMPORTANT TRIALS WITH THE 174 00:08:15,160 --> 00:08:16,880 POPULATION AT LARGE AND IN THE 175 00:08:16,880 --> 00:08:20,200 MOST EXTREME FORMS THEY MAY 176 00:08:20,200 --> 00:08:20,720 NOT BE ABLE TO CONNECT ANY 177 00:08:20,720 --> 00:08:26,560 TRIALS AT ALL FOR THEIR CARE 178 00:08:26,560 --> 00:08:29,640 NEEDS. 179 00:08:29,640 --> 00:08:31,960 SOME PREFER TO ORDER MORE THAT 180 00:08:31,960 --> 00:08:34,360 FUNDING THAT IS MEANT FOR 181 00:08:34,360 --> 00:08:40,040 RESEARCH SO I WILL SAY THIS 182 00:08:40,040 --> 00:08:40,920 ARGUMENT IS IN THE CONTEXT OF 183 00:08:40,920 --> 00:08:45,720 THE IMPLANTED DEVICES IT'S 184 00:08:45,720 --> 00:08:46,280 OBVIOUS BETWEEN RESEARCH AND 185 00:08:46,280 --> 00:08:47,240 CLINICAL CARE. 186 00:08:47,240 --> 00:08:53,640 SOME WOULD ARGUE SO CONSENTING 187 00:08:53,640 --> 00:08:57,080 TO A LACK OF INFORMATION. 188 00:08:57,080 --> 00:08:57,640 AND THIS LACK OF ARRANGEMENT 189 00:08:57,640 --> 00:09:02,520 IS ACCEPTABLE. 190 00:09:02,520 --> 00:09:03,800 AND THEN HOLDING A WORKSHOP IN 191 00:09:03,800 --> 00:09:14,160 2017 WITH TOPICS AROUND CARE. 192 00:09:14,160 --> 00:09:14,680 BUT THEN TO GO THROUGH THE 193 00:09:14,680 --> 00:09:16,760 FRAMEWORKS AND STANDARD 194 00:09:16,760 --> 00:09:24,640 PRACTICES. 195 00:09:24,640 --> 00:09:26,680 AND THEN WITH THE MEDICAL 196 00:09:26,680 --> 00:09:33,960 DEVICES AND THE NEWG WORKING 197 00:09:33,960 --> 00:09:34,520 GROUP DRAFTED THE FOLLOWING 198 00:09:34,520 --> 00:09:35,120 TREATY OF THINGS TO CONSIDER. 199 00:09:35,120 --> 00:09:36,560 FIRST PROCESSED TRIAL NEEDS 200 00:09:36,560 --> 00:09:39,040 SHED ANTICIPATE AHEAD OF THE 201 00:09:39,040 --> 00:09:39,600 TRIAL IN DIFFERENT SCENARIO 202 00:09:39,600 --> 00:09:44,720 SHOULD BE PLANNED FOR. 203 00:09:44,720 --> 00:09:44,960 SECOND. 204 00:09:44,960 --> 00:09:45,560 PROFESSIONAL STAKEHOLDERS HAVE 205 00:09:45,560 --> 00:09:45,920 A LIMITED SHARED 206 00:09:45,920 --> 00:09:46,400 RESPONSIBILITY TO TAKE 207 00:09:46,400 --> 00:09:48,040 REASONABLE STEPS TO FACILITATE 208 00:09:48,040 --> 00:09:50,800 CONTINUED ACCESS TO DEVICES 209 00:09:50,800 --> 00:09:55,080 THAT BENEFIT PARTICIPANTS AND 210 00:09:55,080 --> 00:09:55,560 THEY MAY HAVE FURTHER 211 00:09:55,560 --> 00:09:56,160 RESPONSIBILITIES. 212 00:09:56,160 --> 00:09:58,480 FINALLY PATIENTS SHOULD BE 213 00:09:58,480 --> 00:09:59,080 INFORMED ABOUT POSTTRIAL NEEDS 214 00:09:59,080 --> 00:10:02,280 AND PLANS. 215 00:10:02,280 --> 00:10:03,320 I WENT TO EMPHASIZE TWO 216 00:10:03,320 --> 00:10:10,080 THINGS. 217 00:10:10,080 --> 00:10:10,600 FIRST IN THIS WORKSHOP THE 218 00:10:10,600 --> 00:10:12,680 RESULTS OF WHICH WERE 219 00:10:12,680 --> 00:10:16,400 PUBLISHED IN THERE APPEARS TO 220 00:10:16,400 --> 00:10:17,240 BE A CONSENSUS IN THE FIELD OF 221 00:10:17,240 --> 00:10:22,240 THESE THREE POINTS SO WE WOULD 222 00:10:22,240 --> 00:10:24,600 LIKE TO TAKE THESE THREE 223 00:10:24,600 --> 00:10:27,000 POINTS AND BASICALLY START 224 00:10:27,000 --> 00:10:28,880 FROM THERE. 225 00:10:28,880 --> 00:10:31,840 THIS ALSO MEANS WE WOULD LIKE 226 00:10:31,840 --> 00:10:34,400 TO LIMIT THE TIME SPENT WITH 227 00:10:34,400 --> 00:10:35,000 THE APPLICABLE FOUNDATIONS OF 228 00:10:35,000 --> 00:10:38,760 THE STATEMENTS AND THE THING 229 00:10:38,760 --> 00:10:40,120 IT MADE PROGRESS ON THE 230 00:10:40,120 --> 00:10:45,480 SPECIFICATIONS. 231 00:10:45,480 --> 00:10:46,520 SO IT'S CURRENTLY GOING ON IN 232 00:10:46,520 --> 00:10:49,000 THE FIELD THERE IS STILL SOME 233 00:10:49,000 --> 00:10:51,800 VARIETY AND THE EXTENT OF 234 00:10:51,800 --> 00:10:58,040 POSTTRIAL CARE AND WHAT THIS 235 00:10:58,040 --> 00:10:58,240 ENTAILS. 236 00:10:58,240 --> 00:11:03,480 BUT THAT IS NOT SURPRISING 237 00:11:03,480 --> 00:11:04,080 CONSIDERING FROM THE WORKING 238 00:11:04,080 --> 00:11:04,720 GROUP I JUST QUOTED WAS PRETTY 239 00:11:04,720 --> 00:11:08,920 HIGH LEVEL IT DOESN'T REALLY 240 00:11:08,920 --> 00:11:15,960 SAY THAT THIS IS APPROPRIATE 241 00:11:15,960 --> 00:11:26,440 BUT TO ENCOURAGE TO MAKE PLANS 242 00:11:29,120 --> 00:11:30,120 AND THAT HELPS WITH THEIR 243 00:11:30,120 --> 00:11:32,760 LONG-TERM CARE AND SOME FORMER 244 00:11:32,760 --> 00:11:35,040 PARTICIPANTS TO EXPERIENCE 245 00:11:35,040 --> 00:11:36,680 ANXIETY AROUND THE UNCLEAR 246 00:11:36,680 --> 00:11:37,240 INDIAN ACCESS TO THE DEVICE 247 00:11:37,240 --> 00:11:40,800 FOLLOW-UP CARE AND MAINTENANCE. 248 00:11:40,800 --> 00:11:41,280 EVEN A LOSS OF ACCESS TO 249 00:11:41,280 --> 00:11:49,880 BENEFICIAL DEVICES. 250 00:11:49,880 --> 00:11:52,400 SO THE VERY HELPFUL FOR THE 251 00:11:52,400 --> 00:11:54,840 FIELDS RELATED TO 252 00:11:54,840 --> 00:11:56,200 SPECIFICATION AND 253 00:11:56,200 --> 00:11:57,600 IMPLEMENTATION OF THOSE 254 00:11:57,600 --> 00:12:00,000 HIGHER-LEVEL PRINCIPLES I JUST 255 00:12:00,000 --> 00:12:03,640 OUTLINED WHAT ARE THOSE 256 00:12:03,640 --> 00:12:09,840 STAKEHOLDERS TO PROVIDE. 257 00:12:09,840 --> 00:12:19,520 AND HOW ARE THEY PROVIDED FOR 258 00:12:19,520 --> 00:12:21,080 AND WITH THOSE DIALOGUE TO THE 259 00:12:21,080 --> 00:12:25,280 STAKEHOLDER AND IN ORDER TO 260 00:12:25,280 --> 00:12:26,800 PREPARE FOR IT. 261 00:12:26,800 --> 00:12:34,400 AND SOME OF THE MEMBERS IF 262 00:12:34,400 --> 00:12:35,000 THERE WERE POINTS THAT ARE NOT 263 00:12:35,000 --> 00:12:39,720 BEING BROUGHT UP THEN STAFF 264 00:12:39,720 --> 00:12:40,320 MEMBERS WILL MAKE SURE TO ADD 265 00:12:40,320 --> 00:12:43,440 THESE TO THE CONVERSATION. 266 00:12:43,440 --> 00:12:47,880 THE GOAL OF THE WORKSHOP IS TO 267 00:12:47,880 --> 00:12:48,440 TALK REASONABLE EXPECTATIONS 268 00:12:48,440 --> 00:12:50,560 FOR THAT CARE PLANS THAT CAN 269 00:12:50,560 --> 00:12:52,360 INFORM BEST PRACTICES IN THE 270 00:12:52,360 --> 00:12:54,800 COMMUNITY EVENTUALLY. 271 00:12:54,800 --> 00:13:01,080 NOW I JUST WANT TO HIGHLIGHT 272 00:13:01,080 --> 00:13:01,600 THE FOUR PANELS THAT WILL 273 00:13:01,600 --> 00:13:02,120 HOPEFULLY BUILD ON EACH 274 00:13:02,120 --> 00:13:02,320 OTHER. 275 00:13:02,320 --> 00:13:04,440 FIRST WE WILL IDENTIFY THE 276 00:13:04,440 --> 00:13:12,440 POSTTRIAL NEEDS AND IN THOSE 277 00:13:12,440 --> 00:13:13,320 ARE CURRENTLY OVER ALREADY 278 00:13:13,320 --> 00:13:14,440 COVERED IN TOMORROW WE WILL 279 00:13:14,440 --> 00:13:18,480 TAKE THIS LIST OF NEEDS AND 280 00:13:18,480 --> 00:13:23,360 SAY WHAT IS THE MINIMUM OF THE 281 00:13:23,360 --> 00:13:26,760 RESEARCH RELATED CARE? 282 00:13:26,760 --> 00:13:32,160 AND THEN FINALLY THE 283 00:13:32,160 --> 00:13:33,160 DIFFERENCE BETWEEN PANEL 284 00:13:33,160 --> 00:13:36,360 NUMBER THREE INTO WHAT SHOULD 285 00:13:36,360 --> 00:13:40,320 BE FACILITATED AND HOW DOES IT 286 00:13:40,320 --> 00:13:47,640 FILL THE GAPS? 287 00:13:47,640 --> 00:13:48,240 THANK YOU AGAIN FOR BEING HERE 288 00:13:48,240 --> 00:13:48,840 AND SPECIAL THANKS TO THE NIH 289 00:13:48,840 --> 00:13:50,480 PLANNING COMMITTEE WHO HAVE 290 00:13:50,480 --> 00:14:00,720 LED THIS EFFORT. 291 00:14:01,280 --> 00:14:04,480 I WILL HAND IT OVER TO PANEL 292 00:14:04,480 --> 00:14:14,000 NUMBER ONE. 293 00:14:14,000 --> 00:14:14,480 >> THANK YOU SO MUCH. 294 00:14:14,480 --> 00:14:17,960 WE WILL KICKOFF PANEL NUMBER 295 00:14:17,960 --> 00:14:23,360 ONE SO LOOKING AT THE RELATION 296 00:14:23,360 --> 00:14:23,920 TO THEIR TRIAL PARTICIPATION 297 00:14:23,920 --> 00:14:24,400 AFTER THE TRIAL ENDS. 298 00:14:24,400 --> 00:14:27,560 THE FIRST SPEAKER IS 299 00:14:27,560 --> 00:14:28,080 MISS BRANDY ELLIS WHO IS A 300 00:14:28,080 --> 00:14:31,480 PATIENT PARTICIPANT FROM THE 301 00:14:31,480 --> 00:14:32,000 DEVICE CLINICAL TRIALS IN 302 00:14:32,000 --> 00:14:36,120 FIRST ENROLLED IN 2011 AS PART 303 00:14:36,120 --> 00:14:37,320 OF THE PHYSICIAN SPONSORED 304 00:14:37,320 --> 00:14:39,880 EXPERIMENTAL STUDY THAT 305 00:14:39,880 --> 00:14:41,880 INVOLVES DEEP BRAIN 306 00:14:41,880 --> 00:14:43,400 STIMULATION FOR TREATMENT 307 00:14:43,400 --> 00:14:48,600 RESISTANT DEPRESSION USING 308 00:14:48,600 --> 00:14:48,800 DEVICES. 309 00:14:48,800 --> 00:14:49,640 SINCE THEN SHE HAS RECEIVED 310 00:14:49,640 --> 00:14:52,800 ONGOING CARE AND NEGOTIATES 311 00:14:52,800 --> 00:14:57,360 WITHOUT IT FOR HER DEVICE 312 00:14:57,360 --> 00:15:01,920 MAINTENANCE. 313 00:15:01,920 --> 00:15:02,320 >> IT AFTERNOON. 314 00:15:02,320 --> 00:15:04,920 IT IS A PLEASURE TO BE HERE. 315 00:15:04,920 --> 00:15:09,080 I WILL BREEZE THROUGH THE 316 00:15:09,080 --> 00:15:09,600 INTRODUCTION BECAUSE I CAN 317 00:15:09,600 --> 00:15:14,880 TALK ABOUT THIS FOR HOURS SO 318 00:15:14,880 --> 00:15:15,440 WE WILL GO TO THE NEXT SLIDE 319 00:15:15,440 --> 00:15:16,000 AND YOU CAN SEE THIS IS WHAT 320 00:15:16,000 --> 00:15:19,680 IS CURRENTLY IN MY BRAIN. 321 00:15:19,680 --> 00:15:20,240 BEFORE YOU ASK WHY SOMEBODY 322 00:15:20,240 --> 00:15:20,840 WOULD DO THIS, LET'S GO TO THE 323 00:15:20,840 --> 00:15:23,920 NEXT SLIDE, YOU WILL SEE WHY. 324 00:15:23,920 --> 00:15:25,520 I LITERALLY HAD TRIED 325 00:15:25,520 --> 00:15:30,840 EVERYTH EVERYTHING. 326 00:15:30,840 --> 00:15:31,440 IF A DOCTOR COULD THINK OF IT 327 00:15:31,440 --> 00:15:31,800 I WOULD TRY IT. 328 00:15:31,800 --> 00:15:32,080 FOUR YEARS. 329 00:15:32,080 --> 00:15:32,720 WAS COMPLETELY DISABLED. 330 00:15:32,720 --> 00:15:35,920 NOTHING HAS WORKED. 331 00:15:35,920 --> 00:15:42,880 AT THAT POINT I DECIDED IF I 332 00:15:42,880 --> 00:15:43,440 COULD NOT FIND DATA ON WHAT 333 00:15:43,440 --> 00:15:44,040 WORKED FOR TREATMENT RESISTANT 334 00:15:44,040 --> 00:15:47,840 DEPRESSION BECAUSE EVERYTHING 335 00:15:47,840 --> 00:15:50,200 WAS GOAL ORIENTED TO PEOPLE 336 00:15:50,200 --> 00:15:54,320 WHO WERE FEELING LITERALLY 337 00:15:54,320 --> 00:15:56,600 EVERYTHING. 338 00:15:56,600 --> 00:15:59,480 AND I HAD A BELIEVE THAT 339 00:15:59,480 --> 00:16:04,240 NOTHING WOULD WORK BUT STILL 340 00:16:04,240 --> 00:16:04,800 IT WOULD BE BENEFIT DESIGNED 341 00:16:04,800 --> 00:16:06,520 FOR THE PEOPLE WHO COME AFTER 342 00:16:06,520 --> 00:16:10,040 ME SO IF YOU GO TO THE NEXT 343 00:16:10,040 --> 00:16:14,200 SLIDE THIS IS A STUDY I WAS IN 344 00:16:14,200 --> 00:16:16,440 AND THEN GO TO THE NEXT SLIDE 345 00:16:16,440 --> 00:16:24,080 YOU CAN SEE IT IS A REALLY 346 00:16:24,080 --> 00:16:24,560 LONG RECOVERY PROCESS. 347 00:16:24,560 --> 00:16:25,480 I AM VERY THANKFUL IT DID WORK 348 00:16:25,480 --> 00:16:31,080 AND IN THE NEXT SLIDE IT WAS 349 00:16:31,080 --> 00:16:32,320 YEARS FROM THE TIME I DEVICE 350 00:16:32,320 --> 00:16:35,480 WAS IMPLANTED UNTIL I FELT 351 00:16:35,480 --> 00:16:35,680 WELL. 352 00:16:35,680 --> 00:16:41,920 THIS IS NOT A QUICK FIX. 353 00:16:41,920 --> 00:16:42,480 AS PATIENT YOU ARE REALLY 354 00:16:42,480 --> 00:16:43,040 COMMITTING TO THE LONG HAUL 355 00:16:43,040 --> 00:16:45,240 AND FOR ME BECAUSE MY 356 00:16:45,240 --> 00:16:48,880 DEPRESSION WAS SO SEVERE, THE 357 00:16:48,880 --> 00:16:52,520 INITIAL WE NEED YOU TO NOT DIE 358 00:16:52,520 --> 00:16:53,120 FOR THE FIRST YEAR PLEASE YOU 359 00:16:53,120 --> 00:16:54,440 WILL MESS UP OUR EXPERIMENT. 360 00:16:54,440 --> 00:16:57,960 THEY DID NOT SAY THAT BUT 361 00:16:57,960 --> 00:16:58,480 THAT'S HOW SOMEBODY WOULD 362 00:16:58,480 --> 00:17:01,040 INTERNALIZE IT. 363 00:17:01,040 --> 00:17:02,960 IT WAS QUITE A COMMITMENT IF 364 00:17:02,960 --> 00:17:06,800 YOU GO TO THE NEXT SLIDE THESE 365 00:17:06,800 --> 00:17:09,360 ARE THINGS I HAVE EXPERIENCED 366 00:17:09,360 --> 00:17:12,960 OUR FRIENDS HAVE EXPERIENCED 367 00:17:12,960 --> 00:17:17,320 AND THIS LEADS ON WHAT I WOULD 368 00:17:17,320 --> 00:17:24,800 LIKE OF POSTTRIAL CARE. 369 00:17:24,800 --> 00:17:25,360 I WILL GO SPECIFICALLY INTO 370 00:17:25,360 --> 00:17:27,360 SOME OF THE SUGGESTIONS THAT I 371 00:17:27,360 --> 00:17:31,320 HAVE I HAD BATTERY 372 00:17:31,320 --> 00:17:34,120 REPLACEMENTS MY BATTERIES WERE 373 00:17:34,120 --> 00:17:37,400 LASTING BETWEEN 11 AND 13 374 00:17:37,400 --> 00:17:40,080 MONTHS WITH ORIGINAL SETTINGS. 375 00:17:40,080 --> 00:17:42,520 I WAS IN MY THIRTIES. 376 00:17:42,520 --> 00:17:49,240 SO POTENTIALLY FACING 30 OR 40 377 00:17:49,240 --> 00:17:49,880 SURGERIES FOR BATTERY 378 00:17:49,880 --> 00:17:50,720 REPLACEMENTS CUTTING INTO THE 379 00:17:50,720 --> 00:17:52,120 SAME AREA. 380 00:17:52,120 --> 00:17:55,960 NOW I HAVE A RECHARGEABLE 381 00:17:55,960 --> 00:17:56,480 BATTERY BUT IT IS NOT FDA 382 00:17:56,480 --> 00:17:58,280 APPROVED SO THERE IS A RISK I 383 00:17:58,280 --> 00:18:03,520 HAVE TO GO BACK TO A STANDARD 384 00:18:03,520 --> 00:18:06,680 BATTERY AND THOSE ANNUAL 385 00:18:06,680 --> 00:18:07,320 SURGERIES. 386 00:18:07,320 --> 00:18:09,080 I HAVE HAD VARIOUS 387 00:18:09,080 --> 00:18:10,640 MALFUNCTIONS WITH THE 388 00:18:10,640 --> 00:18:13,280 IMPLANTED DEVICE OR THE DEVICE 389 00:18:13,280 --> 00:18:19,720 THAT I USED TO RECHARGE. 390 00:18:19,720 --> 00:18:20,800 AND I AM STILL ENGAGING AND 391 00:18:20,800 --> 00:18:25,920 FOLLOW UP AND I WILL HELP THEM 392 00:18:25,920 --> 00:18:27,120 AS LONG AS THEY FIND MY HELP 393 00:18:27,120 --> 00:18:30,120 BENEFICIAL. 394 00:18:30,120 --> 00:18:31,360 THERE ARE OTHER THINGS I WOULD 395 00:18:31,360 --> 00:18:36,480 LIKE TO SEE IMPROVED GENERAL 396 00:18:36,480 --> 00:18:41,480 SECURITY WERE GETTING TO WHERE 397 00:18:41,480 --> 00:18:42,040 EVERYTHING IS TRACKABLE AND 398 00:18:42,040 --> 00:18:43,640 I'M DEPEND UPON THE FACT THAT 399 00:18:43,640 --> 00:18:44,720 THOSE PEOPLE CLOSE TO ME WANT 400 00:18:44,720 --> 00:18:47,280 TO KEEP ME AND WILL NOT BE 401 00:18:47,280 --> 00:18:57,600 HACKING MY DEVICE. 402 00:18:59,800 --> 00:19:00,240 SO MY FIRST SURGERY WAS 403 00:19:00,240 --> 00:19:02,320 ACTUALLY COVERED BY MY PRIVATE 404 00:19:02,320 --> 00:19:03,920 INSURANCE AND IT IS MY 405 00:19:03,920 --> 00:19:05,880 UNDERSTANDING THE FIRST 406 00:19:05,880 --> 00:19:08,800 PARTICIPANT WHO HAD THEIR 407 00:19:08,800 --> 00:19:11,360 INSURANCE COVER THE INITIAL 408 00:19:11,360 --> 00:19:12,320 PROCEDURE. 409 00:19:12,320 --> 00:19:14,840 I HAVE TO ASSUME THAT WAS IN 410 00:19:14,840 --> 00:19:17,200 PART BECAUSE OF THE LIST OF 411 00:19:17,200 --> 00:19:17,800 ALL OF THE THINGS I HAVE TRIED 412 00:19:17,800 --> 00:19:19,360 WAS VERY EXPENSIVE. 413 00:19:19,360 --> 00:19:24,480 NOTHING WAS WORKING. 414 00:19:24,480 --> 00:19:26,960 SO THIS WAS CONSIDERED A 415 00:19:26,960 --> 00:19:30,920 CHANCE FOR ME TO SURVIVE WITH 416 00:19:30,920 --> 00:19:33,280 LESS EXPENSE AND IT HAS WORKED 417 00:19:33,280 --> 00:19:35,760 MY MEDICAL CARE EXPENSES 418 00:19:35,760 --> 00:19:36,880 PLUMMETED ONCE I WAS NOT 419 00:19:36,880 --> 00:19:40,160 NEEDING AS MUCH CARE. 420 00:19:40,160 --> 00:19:42,200 BUT ONGOING SURGERIES AND 421 00:19:42,200 --> 00:19:49,040 THOSE SORTS OF ISSUES IS I CAN 422 00:19:49,040 --> 00:19:49,640 UNDERSTAND THE INITIAL TRIAL. 423 00:19:49,640 --> 00:19:52,480 THAT IS THE EXPERIMENT I 424 00:19:52,480 --> 00:19:53,040 COMPLETELY UNDERSTAND WHY 425 00:19:53,040 --> 00:19:53,920 INSURANCE WOULD NOT COVER 426 00:19:53,920 --> 00:19:58,040 SOMETHING EXPERIMENTAL. 427 00:19:58,040 --> 00:19:58,520 BUT FOR ME HAVE HAD THIS 428 00:19:58,520 --> 00:20:03,240 DEVICE FOR TEN YEARS IT IS NOT 429 00:20:03,240 --> 00:20:05,320 AN EXPERIMENT FOR ME ANYMORE. 430 00:20:05,320 --> 00:20:08,560 WE KNOW THIS WORKS THIS IS THE 431 00:20:08,560 --> 00:20:12,160 ONLY THING THAT DID WORK AND 432 00:20:12,160 --> 00:20:13,800 IF I NEED TO HAVE BATTERY 433 00:20:13,800 --> 00:20:17,160 REPLACEMENT OR ANYONE OF THOSE 434 00:20:17,160 --> 00:20:20,880 THINGS, IT'S A WAY TO KEEP ME 435 00:20:20,880 --> 00:20:23,120 ALIVE IT IS NOT AN EXPERIMENT 436 00:20:23,120 --> 00:20:29,040 ANYMORE WE KNOW THIS WORKS I 437 00:20:29,040 --> 00:20:31,480 HAD UNFORTUNATE BLINDED 438 00:20:31,480 --> 00:20:32,080 INCIDENT I DID NOT KNOW HIS 439 00:20:32,080 --> 00:20:34,200 OFF FOR A COUPLE OF WEEKS AND 440 00:20:34,200 --> 00:20:41,920 I GOT UNWELL AND THEN WE FOUND 441 00:20:41,920 --> 00:20:42,520 OUT IT WAS OFTEN THAT WE FOUND 442 00:20:42,520 --> 00:20:43,120 OUT IT REALLY DOES WORK AND I 443 00:20:43,120 --> 00:20:44,920 REALLY DO NEED IT. 444 00:20:44,920 --> 00:20:46,480 THE SECOND THING I WOULD FOCUS 445 00:20:46,480 --> 00:20:50,680 ON IS COMPATIBILITY. 446 00:20:50,680 --> 00:20:56,160 I AM CURRENTLY USING A 447 00:20:56,160 --> 00:20:56,720 RECHARGEABLE BATTERY AT THIS 448 00:20:56,720 --> 00:20:59,840 POINT IN TIME HAS SAVED ME SIX 449 00:20:59,840 --> 00:21:00,840 SURGERIES. 450 00:21:00,840 --> 00:21:02,840 BUT THAT BATTERY IS NOT FDA 451 00:21:02,840 --> 00:21:03,080 APPROVED. 452 00:21:03,080 --> 00:21:06,480 MOST PEOPLE WHO GET DBS GET IT 453 00:21:06,480 --> 00:21:08,880 FOR PARKINSON'S AND THEY ARE 454 00:21:08,880 --> 00:21:10,680 OLDER AND THE DEVICE DOES NOT 455 00:21:10,680 --> 00:21:14,520 DRAIN THE BATTERY AS QUICKLY 456 00:21:14,520 --> 00:21:15,120 SO THEY WOULD NOT NEED SURGERY 457 00:21:15,120 --> 00:21:18,960 EVERY SINGLE YEAR. 458 00:21:18,960 --> 00:21:20,160 MAYBE RECHARGEABLE IS NOT AS 459 00:21:20,160 --> 00:21:22,560 NECESSARY FOR THEM BUT FACING 460 00:21:22,560 --> 00:21:24,960 30 OR 40 SURGERIES OVER MY 461 00:21:24,960 --> 00:21:30,480 LIFE EXPECTANCY THAT IS A BIG 462 00:21:30,480 --> 00:21:34,640 DEAL THEY DON'T HAVE A BATTERY 463 00:21:34,640 --> 00:21:35,240 THAT IS FDA APPROVED AND WENT 464 00:21:35,240 --> 00:21:37,840 TO DISCONTINUE PRODUCTION. 465 00:21:37,840 --> 00:21:43,360 SO WHAT I WOULD LIKE IS TO 466 00:21:43,360 --> 00:21:45,000 HAVE INCENTIVES TO MAINTAIN 467 00:21:45,000 --> 00:21:47,040 COMPATIBILITY. 468 00:21:47,040 --> 00:21:55,280 IF YOU GO TO THE NEXT SLI 469 00:21:55,280 --> 00:21:55,800 SLIDE, THERE ARE MULTIPLE 470 00:21:55,800 --> 00:21:56,400 DEVICE MANUFACTURERS BUT THERE 471 00:21:56,400 --> 00:22:04,760 IS NO INCENTIVE FOR ONE 472 00:22:04,760 --> 00:22:05,320 COMPANY TO INVEST IN MAKING 473 00:22:05,320 --> 00:22:09,280 THEIR BATTERY COMPATIBLE WITH 474 00:22:09,280 --> 00:22:09,880 EVERYBODY OR IF THEY WANT TO 475 00:22:09,880 --> 00:22:13,120 START MAKING THIS BATTERY THAT 476 00:22:13,120 --> 00:22:14,560 THERE IS AN APPROPRIATE 477 00:22:14,560 --> 00:22:18,080 SUBSTITUTION. 478 00:22:18,080 --> 00:22:18,680 BECAUSE EXPECTING SOMEONE WHO 479 00:22:18,680 --> 00:22:22,200 IS RELYING ON A DEVICE TO LIVE 480 00:22:22,200 --> 00:22:24,760 AND HAVE AN OPERATION EVERY 481 00:22:24,760 --> 00:22:30,160 YEA YEAR, EVEN IF THIS 482 00:22:30,160 --> 00:22:30,760 BATTERY ENDED AFTER FIVE YEARS 483 00:22:30,760 --> 00:22:32,800 THAT IS STILL A NUMBER OF 484 00:22:32,800 --> 00:22:37,920 SURGERIES ALSO I HAVE HAD 485 00:22:37,920 --> 00:22:40,720 DEVICE FAILURES WITH MY 486 00:22:40,720 --> 00:22:41,280 RECHARGER AND I AM VERY 487 00:22:41,280 --> 00:22:49,800 CONCERNED AT SOME POINT SO I 488 00:22:49,800 --> 00:22:54,800 WOULD LIKE TO QUICKLY BRING UP 489 00:22:54,800 --> 00:22:55,720 THE NEXT SLIDE WHICH IS MY 490 00:22:55,720 --> 00:23:00,440 WISH LIST AND THAT OVERCOMES 491 00:23:00,440 --> 00:23:01,040 THOSE SUGGESTIONS AND THEN WE 492 00:23:01,040 --> 00:23:03,880 CAN GET INTO QUESTIONS. 493 00:23:03,880 --> 00:23:10,880 MY WISH LIST WOULD INCLUDE 494 00:23:10,880 --> 00:23:13,440 THAT I WAS FORTUNATE I HAD 495 00:23:13,440 --> 00:23:17,360 PARENTS THAT WERE WILLING TO 496 00:23:17,360 --> 00:23:17,960 SUPPORT ME WHEN I WAS DISABLED 497 00:23:17,960 --> 00:23:21,200 FROM THE DEPRESSION AND HELPED 498 00:23:21,200 --> 00:23:22,280 I HAD PRIVATE HEALTH INSURANCE 499 00:23:22,280 --> 00:23:25,240 FROM THEM. 500 00:23:25,240 --> 00:23:31,600 I HAD THE ABILITY TO BE 501 00:23:31,600 --> 00:23:32,120 UNEMPLOYED AND HAVE THEM 502 00:23:32,120 --> 00:23:37,080 SUPPORT ME. 503 00:23:37,080 --> 00:23:40,040 IF YOU REQUIRE PARTICIPANTS TO 504 00:23:40,040 --> 00:23:46,040 FOOTBALL THE BILLS THEMSELVES 505 00:23:46,040 --> 00:23:47,560 TO LIVE THEN YOU ONLY GET 506 00:23:47,560 --> 00:23:50,760 PARTICIPANTS LIKE ME WHO HAVE 507 00:23:50,760 --> 00:23:56,720 AN AFFLUENT FAMILY AND CAN 508 00:23:56,720 --> 00:23:57,320 AFFORD TO SUPPORT THEM WHILE 509 00:23:57,320 --> 00:23:57,760 THEY ARE IN THE TRIAL. 510 00:23:57,760 --> 00:23:59,320 AND THAT IS NOT GOOD FOR 511 00:23:59,320 --> 00:24:00,480 ANYBO ANYBODY. 512 00:24:00,480 --> 00:24:07,960 WE NEED MORE DIVERSE PEOPLE 513 00:24:07,960 --> 00:24:08,560 WITH THESE TRIALS AND TO MAKE 514 00:24:08,560 --> 00:24:10,200 THAT HAPPEN THERE HAS TO BE A 515 00:24:10,200 --> 00:24:15,160 WAY TO GIVE THEM SUPPORT. 516 00:24:15,160 --> 00:24:17,640 I WAS DISABLED AND NOT WORKING 517 00:24:17,640 --> 00:24:21,160 BUT CHILDCARE, ANY OF THOSE 518 00:24:21,160 --> 00:24:21,760 MIGHT HAVE MADE THE DIFFERENCE 519 00:24:21,760 --> 00:24:24,480 IN MY RECOVERY. 520 00:24:24,480 --> 00:24:28,440 I WAS VERY FORTUNATE BUT WE 521 00:24:28,440 --> 00:24:33,320 NEED PEOPLE ACROSS ALL 522 00:24:33,320 --> 00:24:33,840 DIFFERENT BACKGROUNDS TO 523 00:24:33,840 --> 00:24:38,360 PARTICIPATE IN THESE TRIALS 524 00:24:38,360 --> 00:24:38,920 AND SUPPORT IS ONE OF THOSE 525 00:24:38,920 --> 00:24:42,520 THINGS THAT IS NECESSARY. 526 00:24:42,520 --> 00:24:45,040 THE NEXT ISSUE OF GUARANTEED 527 00:24:45,040 --> 00:24:46,760 COVERAGES LIKE I SAID I AM 528 00:24:46,760 --> 00:24:49,480 RELYING ON THIS DEVICE. 529 00:24:49,480 --> 00:24:54,240 THE LIKELIHOOD THAT I SURVIVE 530 00:24:54,240 --> 00:24:54,800 IF I CANNOT USE THIS ANYMORE 531 00:24:54,800 --> 00:25:01,880 IS NOT 100 PERCENT SO I AM 532 00:25:01,880 --> 00:25:02,920 CONCERNED I WILL NEVER KNOW 533 00:25:02,920 --> 00:25:05,520 FROM ONE SURGERY TO THE NEXT 534 00:25:05,520 --> 00:25:06,000 IF THE NEXT ONE WILL BE 535 00:25:06,000 --> 00:25:09,560 COVERED BY INSURANCE. 536 00:25:09,560 --> 00:25:10,120 I WILL NEVER KNOW IF I GET 537 00:25:10,120 --> 00:25:15,960 INTO A CAR ACCIDENT IF THE 538 00:25:15,960 --> 00:25:16,560 BRAIN SURGERY IS COVERED BY MY 539 00:25:16,560 --> 00:25:18,640 INSURANCE OR FACE THE PROSPECT 540 00:25:18,640 --> 00:25:21,200 OF NO LONGER HAVING THIS 541 00:25:21,200 --> 00:25:22,800 DEVICE. 542 00:25:22,800 --> 00:25:26,160 I WOULD LIKE THERE TO BE AWAY 543 00:25:26,160 --> 00:25:28,480 TO SAY YOU DID THIS EXPERIMENT 544 00:25:28,480 --> 00:25:30,280 AS PART OF THE CLINICAL TRIAL 545 00:25:30,280 --> 00:25:32,200 THAT WAS APPROVED AND SINCE IT 546 00:25:32,200 --> 00:25:35,440 WORKS FOR YOU THIS IS NO 547 00:25:35,440 --> 00:25:37,280 LONGER AN EXPERIMENT FOR YOU. 548 00:25:37,280 --> 00:25:42,720 I HAVE NO CONTROL. 549 00:25:42,720 --> 00:25:48,360 PERPETUAL POINT OF CONTRACT 550 00:25:48,360 --> 00:25:48,960 THEY HAVE SUPPORTED ME FOR ALL 551 00:25:48,960 --> 00:25:52,440 TEN YEARS WITHOUT QUESTION FOR 552 00:25:52,440 --> 00:25:55,040 30 YEARS FROM NOW WHEN I'M IN 553 00:25:55,040 --> 00:26:02,040 THE RETIREMENT HOME I DON'T 554 00:26:02,040 --> 00:26:02,640 KNOW WHO WILL BE RESPONSIBLE 555 00:26:02,640 --> 00:26:05,680 FOR CHECKING MY DEVICE 556 00:26:05,680 --> 00:26:06,360 SETTINGS. 557 00:26:06,360 --> 00:26:07,920 AND I WOULD VERY MUCH LIKE 558 00:26:07,920 --> 00:26:15,080 THERE TO BE A REQUIREMENT IF 559 00:26:15,080 --> 00:26:19,720 IT'S IN MY HEAD AND IT WORKS 560 00:26:19,720 --> 00:26:20,760 TO SAY WE'VE DECIDED NOT TO 561 00:26:20,760 --> 00:26:22,560 MAKE THIS ANYMORE AND NOT TO 562 00:26:22,560 --> 00:26:30,800 COVER THIS ANYMORE THAT IF YOU 563 00:26:30,800 --> 00:26:31,400 STOP MAKING THIS BATTERY THERE 564 00:26:31,400 --> 00:26:32,240 HAS TO BE A COMPATIBLE 565 00:26:32,240 --> 00:26:34,040 ALTERNATIVE AND UNTIL THERE IS 566 00:26:34,040 --> 00:26:36,280 YOU CANNOT ABANDON THE 567 00:26:36,280 --> 00:26:40,480 PATIENT'S SO SOME MINOR THINGS 568 00:26:40,480 --> 00:26:41,760 I WOULD LIKE AS FAR AS 569 00:26:41,760 --> 00:26:45,480 DOCUMENTATION I THINK A 570 00:26:45,480 --> 00:26:46,000 REGISTRY OR SOMETHING THE 571 00:26:46,000 --> 00:26:49,320 MATTER WHERE YOU ARE SOMEBODY 572 00:26:49,320 --> 00:26:56,080 CAN FIND OUT THE SETTINGS IF I 573 00:26:56,080 --> 00:26:59,160 AM TIRED OF PORTUGAL I WILL 574 00:26:59,160 --> 00:27:00,840 NEED A SHEET OF PAPER TO TAKE 575 00:27:00,840 --> 00:27:06,640 TO A DOCTOR TO SAY THIS IS 576 00:27:06,640 --> 00:27:07,240 WHAT I HAVE IN THESE ARE THE 577 00:27:07,240 --> 00:27:07,840 SETTINGS AND THIS IS WHAT YOU 578 00:27:07,840 --> 00:27:09,640 NEED TO VERIFY. 579 00:27:09,640 --> 00:27:13,600 I THINK PARTICIPANTS SHOULD 580 00:27:13,600 --> 00:27:14,160 AUTOMATICALLY GET ACCESS TO 581 00:27:14,160 --> 00:27:17,840 ALL PUBLICATIONS. 582 00:27:17,840 --> 00:27:18,440 BECAUSE I'M ONE OF THE PEOPLE 583 00:27:18,440 --> 00:27:20,480 THAT READS ALL OF THE 584 00:27:20,480 --> 00:27:24,280 PUBLICATIONS. 585 00:27:24,280 --> 00:27:27,840 THAT IS MY RECOMMENDATIONS 586 00:27:27,840 --> 00:27:32,040 THOSE THAT HAVE DONE FOLLOW UP 587 00:27:32,040 --> 00:27:34,400 AND I'M HAPPY TO ANSWER ANY 588 00:27:34,400 --> 00:27:44,920 QUESTIONS IF ANYBODY HAS ANY. 589 00:27:49,000 --> 00:27:51,480 >> WE HAVE TIME FOR ONE 590 00:27:51,480 --> 00:27:56,760 QUESTION AND THEN WE CAN GET 591 00:27:56,760 --> 00:28:04,680 INTO THE ISSUES BUT THE 592 00:28:04,680 --> 00:28:10,800 QUESTION. 593 00:28:10,800 --> 00:28:16,680 >> 90 PERCENT IS A THANK YOU 594 00:28:16,680 --> 00:28:20,480 FOR CONVEYING THE STARTS WE 595 00:28:20,480 --> 00:28:24,600 HAVE PLENTY OF WORK TO DO AND 596 00:28:24,600 --> 00:28:28,320 AMAZING IT IS TO FOLLOW UP ON. 597 00:28:28,320 --> 00:28:28,880 IT'S VERY COURAGEOUS OF YOU. 598 00:28:28,880 --> 00:28:33,440 THANK YOU. 599 00:28:33,440 --> 00:28:36,800 I'M HAPPY YOU HAVE DONE WELL. 600 00:28:36,800 --> 00:28:38,800 YOU HAD HAD QUITE A BIT OF 601 00:28:38,800 --> 00:28:43,960 TIME TO REFLECT THE EXPERIENCE 602 00:28:43,960 --> 00:28:49,480 OVER THE YEARS SO IS THERE A 603 00:28:49,480 --> 00:28:54,560 COMMUNITY OUT THERE THAT YOU 604 00:28:54,560 --> 00:28:59,920 HAD TIME TO THINK ABOUT THIS 605 00:28:59,920 --> 00:29:09,160 AND THEN TO SPEAK TO WHAT IS 606 00:29:09,160 --> 00:29:13,320 THAT EXPERIENCE IS THERE A LOT 607 00:29:13,320 --> 00:29:15,800 OF DISCUSSION ABOUT THIS HOW 608 00:29:15,800 --> 00:29:18,840 IS THIS DISCUSSED BETWEEN 609 00:29:18,840 --> 00:29:22,680 YOURSELF AND OTHERS. 610 00:29:22,680 --> 00:29:23,720 >> ABSOLUTELY IT IS AN 611 00:29:23,720 --> 00:29:25,680 EXCELLENT QUESTION I HAVE A 612 00:29:25,680 --> 00:29:30,080 VERY CLOSE FRIEND I MET IN THE 613 00:29:30,080 --> 00:29:30,600 TRIAL AND WHEN MY CHARGER 614 00:29:30,600 --> 00:29:34,360 BROKE SHE LET ME BORROW HERS I 615 00:29:34,360 --> 00:29:40,560 UNDERSTAND THEY CANNOT HAND 616 00:29:40,560 --> 00:29:41,080 OUT INFORMATION FOR OTHER 617 00:29:41,080 --> 00:29:41,680 PARTICIPANTS TO LET YOU BORROW 618 00:29:41,680 --> 00:29:44,120 THEIR EQUIPMENT. 619 00:29:44,120 --> 00:29:45,480 AND FOUR YEARS SHE HAD A 620 00:29:45,480 --> 00:29:48,000 FACEBOOK GROUP FOR PEOPLE WHO 621 00:29:48,000 --> 00:29:51,880 WERE CONSIDERING DEEP BRAIN 622 00:29:51,880 --> 00:29:55,840 STIMULATION I WAS IN A 623 00:29:55,840 --> 00:30:00,760 DOCUMENTARY PUT ON BY PBS AND 624 00:30:00,760 --> 00:30:01,800 IN THE COURSE OF LIFE TREATING 625 00:30:01,800 --> 00:30:05,160 THAT RELEASE I HAVE HAD PEOPLE 626 00:30:05,160 --> 00:30:07,720 FROM BRAZIL AND OTHER 627 00:30:07,720 --> 00:30:09,400 COUNTRIES REACH OUT TO ME ON 628 00:30:09,400 --> 00:30:12,160 SOCIAL MEDIA AND SAY HEY I AM 629 00:30:12,160 --> 00:30:14,760 FACING SIMILAR ISSUES WHAT ARE 630 00:30:14,760 --> 00:30:17,280 THOSE THINGS I SHOULD BE AWARE 631 00:30:17,280 --> 00:30:25,440 OF? 632 00:30:25,440 --> 00:30:25,960 THERE IS A COMMUNITY AND 633 00:30:25,960 --> 00:30:26,520 PLATFORMS THAT DISCUSS THIS 634 00:30:26,520 --> 00:30:29,560 AND WHEN I WAS TALKING TO MY 635 00:30:29,560 --> 00:30:32,480 FRIEND ABOUT POSTTRIAL WISH 636 00:30:32,480 --> 00:30:36,560 LIST WE ALL HAVE SIMILAR 637 00:30:36,560 --> 00:30:38,920 EXPERIENCES IN THESE 638 00:30:38,920 --> 00:30:41,560 DISCUSSIONS DO HAPPEN THAT MY 639 00:30:41,560 --> 00:30:44,160 FRIEND IS ONE OF THE PEOPLE 640 00:30:44,160 --> 00:30:49,840 WHO THE INSURANCE COVERED IN 641 00:30:49,840 --> 00:30:50,400 AND SAID WE WILL NOT COVER 642 00:30:50,400 --> 00:30:51,000 THIS ANYMORE BECAUSE WE DON'T 643 00:30:51,000 --> 00:30:52,240 COVER EXPERIMENTS. 644 00:30:52,240 --> 00:30:53,920 WE ARE CHANGING A POLICY. 645 00:30:53,920 --> 00:30:57,400 THOSE FEARS ARE FOUNDED BASED 646 00:30:57,400 --> 00:30:58,320 ON THE EXPERIENCE OF PEOPLE I 647 00:30:58,320 --> 00:31:04,480 INTERACT WITH I CAN SPEAK 648 00:31:04,480 --> 00:31:09,080 PERIOD PUBLICLY WITH MY ISSUES 649 00:31:09,080 --> 00:31:12,440 WITH DEPRESSION AND WHAT THE 650 00:31:12,440 --> 00:31:13,160 TRIAL HAS DONE FOR ME AND THEY 651 00:31:13,160 --> 00:31:15,920 DO THAT IN PART BECAUSE PEOPLE 652 00:31:15,920 --> 00:31:17,800 CANNOT DISCUSS THIS BECAUSE 653 00:31:17,800 --> 00:31:21,920 THERE IS STILL'S A LOT OF 654 00:31:21,920 --> 00:31:22,920 STIGMA. 655 00:31:22,920 --> 00:31:25,320 SO I SPEAK UP BECAUSE I CAN 656 00:31:25,320 --> 00:31:32,600 AND NOT EVERYBODY ELSE CAN. 657 00:31:32,600 --> 00:31:33,160 BACK IN THE DAYS THERE WAS A 658 00:31:33,160 --> 00:31:34,640 GOOGLE PLUS I HAD AMA WHERE 659 00:31:34,640 --> 00:31:35,920 PEOPLE JUST ASK QUESTIONS 660 00:31:35,920 --> 00:31:41,280 ABOUT THE DEVICE AND THE TRIAL 661 00:31:41,280 --> 00:31:43,440 AND MY EXPERIENCES AND 662 00:31:43,440 --> 00:31:45,800 EVERYTHING FROM AN ENGINEER SO 663 00:31:45,800 --> 00:31:50,280 HOW DO YOU RECHARGE THAT TO 664 00:31:50,280 --> 00:31:52,680 WHAT IS ALL DAY BRAIN SURGERY 665 00:31:52,680 --> 00:31:56,360 WHEN YOU ARE AWA AWAKE. 666 00:31:56,360 --> 00:31:58,560 SO I NEEDED THAT WHEN WE FIRST 667 00:31:58,560 --> 00:32:01,920 STARTED THE TRIAL. 668 00:32:01,920 --> 00:32:05,560 YOU TALK TO THE OTHER PATIENTS 669 00:32:05,560 --> 00:32:06,160 AND THAT SUPPORT WAS CRUCIAL. 670 00:32:06,160 --> 00:32:08,480 I UNDERSTAND THAT'S NOT 671 00:32:08,480 --> 00:32:11,400 NECESSARILY SOMETHING THE 672 00:32:11,400 --> 00:32:12,000 TRIAL TEAM CAN COORDINATE BUT 673 00:32:12,000 --> 00:32:14,280 IT ENDED UP TO BE CRITICAL FOR 674 00:32:14,280 --> 00:32:17,520 MY LONG-TERM PARTICIPATION. 675 00:32:17,520 --> 00:32:18,640 AND I WOULD NOT BE DOING AS 676 00:32:18,640 --> 00:32:22,280 WELL I —- AS I AM IF I DID NOT 677 00:32:22,280 --> 00:32:22,840 DEVELOP THOSE RELATIONSHIPS 678 00:32:22,840 --> 00:32:27,680 WITH PEOPLE. 679 00:32:27,680 --> 00:32:28,160 >> I HAVE SO MANY MORE 680 00:32:28,160 --> 00:32:28,720 QUESTIONS I WILL PUT THEM IN 681 00:32:28,720 --> 00:32:35,920 THE Q&A. 682 00:32:35,920 --> 00:32:36,520 >> NOW WE WILL MOVE ON TO THE 683 00:32:36,520 --> 00:32:41,040 NEXT PANELISTS. 684 00:32:41,040 --> 00:32:44,320 THE ONE ISSUE THE QUESTIONS IN 685 00:32:44,320 --> 00:32:48,800 THE Q&A THEY WILL NOT GO TO 686 00:32:48,800 --> 00:32:49,360 THE PUBLIC RECORDING BUT WE 687 00:32:49,360 --> 00:32:51,560 WILL DO OUR BEST TO RECYCLE 688 00:32:51,560 --> 00:32:53,000 SOME OF THESE WITH THE PANEL 689 00:32:53,000 --> 00:32:56,720 DISCUSSION. 690 00:32:56,720 --> 00:33:00,320 >> SO NOW WE WILL MOVE ON TO 691 00:33:00,320 --> 00:33:02,800 MISS JENNIFER FRENCH. 692 00:33:02,800 --> 00:33:03,800 AS A RESULT OF THE 693 00:33:03,800 --> 00:33:04,800 SNOWBOARDING ACCIDENT SHE 694 00:33:04,800 --> 00:33:10,520 BECAME A QUADRA COLLEGIATE 695 00:33:10,520 --> 00:33:14,440 FROM 1988 FROM C SIX AND SEVEN 696 00:33:14,440 --> 00:33:15,560 SHE HAS A IMPLANTED NEURAL 697 00:33:15,560 --> 00:33:18,400 PRODUCT THESIS SYSTEM SHE'S 698 00:33:18,400 --> 00:33:21,840 FOUNDER OF THE EUROTECH 699 00:33:21,840 --> 00:33:26,760 NETWORK A 501(C)3 NONPROFIT 700 00:33:26,760 --> 00:33:27,320 ORGANIZATION THAT FOCUSES ON 701 00:33:27,320 --> 00:33:29,360 EDUCATION AND SUPPORT FOR 702 00:33:29,360 --> 00:33:35,040 NEUROTECHNOLOGY. 703 00:33:35,040 --> 00:33:40,160 AND THEN THE AUTHOR OF BIONIC 704 00:33:40,160 --> 00:33:41,200 PERIOD PIONEERS. 705 00:33:41,200 --> 00:33:48,240 >> BRANDY, FANTASTIC JOB 706 00:33:48,240 --> 00:33:56,120 YOU'RE A HARD ACT TO FOLLOW. 707 00:33:56,120 --> 00:34:03,680 AND THAT GRATEFUL FOR THAT 708 00:34:03,680 --> 00:34:04,280 IMPLICATION THE NEXT COUPLE OF 709 00:34:04,280 --> 00:34:06,280 DAYS IT IS INCREDIBLY 710 00:34:06,280 --> 00:34:08,560 IMPORTANT TO LOOK AT THE 711 00:34:08,560 --> 00:34:10,920 EXPANSION OF THE IMPLANTED 712 00:34:10,920 --> 00:34:14,520 DEVICES. 713 00:34:14,520 --> 00:34:15,080 IF WE THINK OF THE DIFFERENT 714 00:34:15,080 --> 00:34:15,600 ROLES THAT WE PLAY IN 715 00:34:15,600 --> 00:34:17,360 NEUROTECHNOLOGY DEVICES THEY 716 00:34:17,360 --> 00:34:19,840 CAN BE AND USERS AND TRIAL 717 00:34:19,840 --> 00:34:23,520 PARTICIPANTS IN MAKING 718 00:34:23,520 --> 00:34:24,080 DECISIONS THAT ALL OF THOSE 719 00:34:24,080 --> 00:34:28,600 WITH LIVED EXPERIENCE WITH 720 00:34:28,600 --> 00:34:29,160 INDIVIDUAL EXPERIENCES WITH 721 00:34:29,160 --> 00:34:34,040 NEUROLOGICAL CONDITIONS. 722 00:34:34,040 --> 00:34:41,400 AS A NONPROFIT AND THOSE 723 00:34:41,400 --> 00:34:43,800 LIVING WITH NEUROLOGICAL 724 00:34:43,800 --> 00:34:50,040 CONDITIONS. 725 00:34:50,040 --> 00:34:50,560 NOT JUST THE FOUNDER BUT 726 00:34:50,560 --> 00:34:51,120 SOMEBODY WITH THE CONDITIONS 727 00:34:51,120 --> 00:34:52,720 OF 24 YEARS AGO I HAD AN 728 00:34:52,720 --> 00:34:57,000 ACCIDENT THAT LEFT ME 729 00:34:57,000 --> 00:34:59,400 QUADRIPLEGIC AND A YEAR AND A 730 00:34:59,400 --> 00:34:59,960 HALF LATER I WAS IMPLANTED 731 00:34:59,960 --> 00:35:06,040 WITH A NARROW PROSTHESIS AND 732 00:35:06,040 --> 00:35:06,560 WITH LONG-TERM PARALYSIS I 733 00:35:06,560 --> 00:35:07,160 REALIZE HAVING THIS DEVICE OF 734 00:35:07,160 --> 00:35:08,400 HOW MUCH IT HAS IMPACTED MY 735 00:35:08,400 --> 00:35:10,680 MEDICAL HEALTH AND MY ABILITY 736 00:35:10,680 --> 00:35:13,360 TO COMBAT SECONDARY CONDITIONS 737 00:35:13,360 --> 00:35:18,080 THAT THE ABILITY TO STAND 738 00:35:18,080 --> 00:35:18,680 USING PARALYZED MUSCLES HAS A 739 00:35:18,680 --> 00:35:28,880 LIFE IMPACT. 740 00:35:33,640 --> 00:35:36,080 IT TO BE IN OTHER AREAS OF THE 741 00:35:36,080 --> 00:35:39,640 BODY THOSE THAT ARE PUTTING 742 00:35:39,640 --> 00:35:43,440 THEIR BODIES FORWARD WITH THE 743 00:35:43,440 --> 00:35:47,960 ADVANCE OF NARROW TECHNOLOGY 744 00:35:47,960 --> 00:35:53,720 AND THEN THE FIRST PARTICIPANT 745 00:35:53,720 --> 00:35:54,320 TO USE THE BRAIN INTERFACE TO 746 00:35:54,320 --> 00:35:57,760 INTERACT WITH PEOPLE WHO WAS A 747 00:35:57,760 --> 00:36:01,440 LONG TIME TRIAL PARTICIPANT TO 748 00:36:01,440 --> 00:36:11,960 REAP THE REWARDS AND WITH THAT 749 00:36:12,320 --> 00:36:15,120 SPINAL CORD DEVICE LIVED WITH 750 00:36:15,120 --> 00:36:18,480 CHRONIC PLANE AND NEVER FOUND 751 00:36:18,480 --> 00:36:19,040 SOLUTION UNTIL SHE HAD THIS 752 00:36:19,040 --> 00:36:23,000 DEVICE AND THEN THOSE WHO WAS 753 00:36:23,000 --> 00:36:30,000 A PARTICIPANT TO RESTORE 754 00:36:30,000 --> 00:36:30,520 SENSATION FOR A PROSTHETIC 755 00:36:30,520 --> 00:36:33,600 LENS SO ALL OF THE'S PEOPLE 756 00:36:33,600 --> 00:36:35,360 ARE JUST A FEW BUT WE PUT THEM 757 00:36:35,360 --> 00:36:39,320 FORWARD AND RIGHTFULLY SO 758 00:36:39,320 --> 00:36:39,880 THESE ARE THINGS THAT ARE 759 00:36:39,880 --> 00:36:42,040 HAPPENING IN THIS FIELD THAT 760 00:36:42,040 --> 00:36:45,480 WE TEND TO IGNORE AFTER THE 761 00:36:45,480 --> 00:36:46,400 HEADLINES FADE IN THE TRIAL IS 762 00:36:46,400 --> 00:36:54,440 OVER WITH AND THEN TO KEEP 763 00:36:54,440 --> 00:36:57,480 THAT EXCITEMENT OF HOW PEOPLE 764 00:36:57,480 --> 00:36:59,800 ARE LIVING. 765 00:36:59,800 --> 00:37:02,280 AND OTHER LIVING WITH THAT 766 00:37:02,280 --> 00:37:07,000 LONG-TERM AND THEN TO KEEP IN 767 00:37:07,000 --> 00:37:17,040 MIND OF THE WHY AND I DRAW 768 00:37:17,040 --> 00:37:22,720 YOUR ATTENTION TO THIS THE TOP 769 00:37:22,720 --> 00:37:23,280 THREE REASONS OF WHY PEOPLE 770 00:37:23,280 --> 00:37:27,840 PARTICIPATE IN CLINICAL TRIALS 771 00:37:27,840 --> 00:37:29,320 AND IT IS COMPELLING TO KEEP 772 00:37:29,320 --> 00:37:34,040 IN MIND AS WE MOVE TOWARD 773 00:37:34,040 --> 00:37:38,240 SOLUTIONS IT IS A HORSE RACE 774 00:37:38,240 --> 00:37:45,760 IT HAS POTENTIAL BENEFITS AND 775 00:37:45,760 --> 00:37:46,320 THEN TO HELP ADVANCE SCIENCE 776 00:37:46,320 --> 00:37:49,840 BUT ALSO ACCESS TO TREATMENTS 777 00:37:49,840 --> 00:37:55,600 AND DEVICES LOOKING AT ALL THE 778 00:37:55,600 --> 00:37:56,120 OTHER TREATMENTS THERE IS 779 00:37:56,120 --> 00:37:56,720 NOTHING ELSE AVAILABLE FOR HER 780 00:37:56,720 --> 00:38:00,480 IN A CLINICAL TRIAL IT WAS AN 781 00:38:00,480 --> 00:38:01,400 OPTION FOR HER AND ALSO FOR ME 782 00:38:01,400 --> 00:38:05,120 BUT LOOKING AT PERSONAL 783 00:38:05,120 --> 00:38:09,960 BENEFIT'S WE HAVE TO SEE HOW 784 00:38:09,960 --> 00:38:12,040 PEOPLE APPROACH CLINICAL 785 00:38:12,040 --> 00:38:13,520 TRIALS AND WHY THEY 786 00:38:13,520 --> 00:38:18,120 PARTICIPATE ONCE THE TRIAL IS 787 00:38:18,120 --> 00:38:23,080 OVER WANT TO SHARE WITH YOU WE 788 00:38:23,080 --> 00:38:24,240 RECENTLY PRESENTED THIS AT THE 789 00:38:24,240 --> 00:38:26,240 INSTITUTES A SCIENTIFIC 790 00:38:26,240 --> 00:38:31,280 RESEARCH AGENDA THAT THIS IS 791 00:38:31,280 --> 00:38:31,880 JUST A PIECE OF THE FRAMEWORK 792 00:38:31,880 --> 00:38:34,160 AS VALUE INTEGRATION WITH THE 793 00:38:34,160 --> 00:38:36,640 MEDICAL WORKING GROUP AND THE 794 00:38:36,640 --> 00:38:40,680 FACT THAT ETHICS NEED TO BE 795 00:38:40,680 --> 00:38:47,240 EMBEDDED INTO THE SPECTRUM IS 796 00:38:47,240 --> 00:38:47,760 NOT JUST THE INCEPTION AND 797 00:38:47,760 --> 00:38:51,440 PLANNING STAGES BUT ENGAGEMENT 798 00:38:51,440 --> 00:38:53,560 AND THOSE THAT CAN HELP PUT 799 00:38:53,560 --> 00:39:02,720 SOME SCOPE IN PLANNING AND IN 800 00:39:02,720 --> 00:39:06,760 THAT DEVELOPMENT STAGE THAT 801 00:39:06,760 --> 00:39:08,200 KEY AREA OF TRANSPARENCY AND 802 00:39:08,200 --> 00:39:09,960 ACCOUNTABILITY AND MOTIVATION 803 00:39:09,960 --> 00:39:12,240 OF THOSE PLAYERS THAT ARE 804 00:39:12,240 --> 00:39:12,880 ROOTED IN THAT DEVELOPMENT 805 00:39:12,880 --> 00:39:16,160 STAGE AND THEN FINALLY 806 00:39:16,160 --> 00:39:21,560 REGULATORY OVERSIGHT BUT ALSO 807 00:39:21,560 --> 00:39:26,880 THE ETHICAL ISSUES THAT CENTER 808 00:39:26,880 --> 00:39:29,360 AROUND CULTURAL AND SOCIETAL 809 00:39:29,360 --> 00:39:33,080 ISSUES AND THAT COULD BE VERY 810 00:39:33,080 --> 00:39:35,600 PRAGMATIC SO THAT IS A DRAFTED 811 00:39:35,600 --> 00:39:44,120 FRAMEWORK TO GIVE YOU AN IDEA 812 00:39:44,120 --> 00:39:44,600 SO WE HAD BEEN FOLLOWING 813 00:39:44,600 --> 00:39:51,040 PEOPLE THAT ARE EARLY ADOPTERS 814 00:39:51,040 --> 00:39:51,640 THERE ARE LOTS OF STORIES AND 815 00:39:51,640 --> 00:39:54,800 DIFFERENT EXPERIENCES SO 816 00:39:54,800 --> 00:39:59,480 LOOKING BACK AT THOSE STORIES 817 00:39:59,480 --> 00:40:00,080 AND INTERVIEWS THAT HAVE BEEN 818 00:40:00,080 --> 00:40:03,760 DONE IN PREPARATION WANT TO 819 00:40:03,760 --> 00:40:06,200 SHARE WITH YOU THE EMERGING 820 00:40:06,200 --> 00:40:11,400 THEMES SO ONE OF THE FIRST 821 00:40:11,400 --> 00:40:13,840 AREAS WAS MAINTENANCE AND 822 00:40:13,840 --> 00:40:19,600 REPAIR SO BEING ABLE TO LIVE 823 00:40:19,600 --> 00:40:20,200 WITH THE DEVICE AND HOW YOU 824 00:40:20,200 --> 00:40:20,680 GET IT REPAIRED IS A BIG 825 00:40:20,680 --> 00:40:23,800 QUESTION BUT A LOT OF TIMES 826 00:40:23,800 --> 00:40:26,760 ENGINEERS THINK OF BACKWARD 827 00:40:26,760 --> 00:40:28,240 COMPATIBILITY BUT WHAT WILL 828 00:40:28,240 --> 00:40:30,360 HAPPEN IN THE NEXT GENERATION 829 00:40:30,360 --> 00:40:39,240 TO BE COMPATIBLE AND THEN TO 830 00:40:39,240 --> 00:40:47,440 UPGRADE THE DEVICE LATER ON. 831 00:40:47,440 --> 00:40:51,680 WHAT IS THE ELIGIBILITY? 832 00:40:51,680 --> 00:40:59,320 AND THEN CONSUMABLES. 833 00:40:59,320 --> 00:40:59,920 OF COURSE THERE ARE BATTERIES 834 00:40:59,920 --> 00:41:00,360 BUT THERE ARE OTHER 835 00:41:00,360 --> 00:41:00,840 CONSUMABLES THAT GO WITH 836 00:41:00,840 --> 00:41:01,440 IMPLANTED DEVICES THAT COULD 837 00:41:01,440 --> 00:41:08,080 BE EXTERNAL TO THE BODY AND 838 00:41:08,080 --> 00:41:09,880 THE SECOND AREA OF 839 00:41:09,880 --> 00:41:13,680 SIMILARITIES AND THEN THE 840 00:41:13,680 --> 00:41:17,360 FINANCIAL BURDEN THAT COMES 841 00:41:17,360 --> 00:41:20,760 ALONG HAVING NO LONG-TERM 842 00:41:20,760 --> 00:41:31,240 IMPLANTED DEVICE SO THAT IS 843 00:41:32,720 --> 00:41:34,200 OUT OF COSTUME AND THE FUNDING 844 00:41:34,200 --> 00:41:37,520 ENDS IT GOES BACK TO THE 845 00:41:37,520 --> 00:41:41,200 PARTICIPANT AND ALSO TO TRACK 846 00:41:41,200 --> 00:41:44,840 THE USAGE OF THOSE DEVICES AND 847 00:41:44,840 --> 00:41:46,800 IF THAT IS WORTHWHILE AND THAT 848 00:41:46,800 --> 00:41:49,320 CONCERNED ABOUT LONG-TERM 849 00:41:49,320 --> 00:41:57,360 FOLLOW-UP AND THEN HOW LONG 850 00:41:57,360 --> 00:42:02,400 WILL IT BE FOR THE BENEFIT 851 00:42:02,400 --> 00:42:06,600 ONCE THE TRIAL IS OVER? 852 00:42:06,600 --> 00:42:09,000 >> THAT AREA OF EMERGING 853 00:42:09,000 --> 00:42:12,000 ISSUES IS STILL ADVERSE EVENTS 854 00:42:12,000 --> 00:42:19,680 AND LOSS OF FUNCTION. 855 00:42:19,680 --> 00:42:24,880 AND THOSE OTHER ISSUES. 856 00:42:24,880 --> 00:42:27,440 AND ALSO REFLECTING A LOSS OF 857 00:42:27,440 --> 00:42:32,160 FUNCTION. 858 00:42:32,160 --> 00:42:33,240 AND THEN HOW WILL THEY HAVE 859 00:42:33,240 --> 00:42:36,800 LOST FUNCTION WHEN THEY PLANT 860 00:42:36,800 --> 00:42:44,080 THE DEVICE AND THEN WHICH THE 861 00:42:44,080 --> 00:42:46,560 PARTICIPANTS AND WHAT THAT 862 00:42:46,560 --> 00:42:49,440 MIGHT ENTAIL AND WHAT THE 863 00:42:49,440 --> 00:42:52,880 OPTIONS MIGHT BE. 864 00:42:52,880 --> 00:42:59,280 IF THE TRIAL IS OVER WITH WHAT 865 00:42:59,280 --> 00:43:02,640 ABOUT INFECTIONS WITH THAT 866 00:43:02,640 --> 00:43:04,800 DEVICE AND THE PSYCHOLOGICAL 867 00:43:04,800 --> 00:43:06,960 IMPACT AND PEOPLE THAT HAVE 868 00:43:06,960 --> 00:43:10,520 BEEN IN VARIOUS TRIALS AND NOT 869 00:43:10,520 --> 00:43:12,240 JUST NEUROPSYCHIATRIC BUT ALL 870 00:43:12,240 --> 00:43:15,800 OF THE OTHER CONDITIONS OF 871 00:43:15,800 --> 00:43:18,080 ONCE THE TRIAL IS OVER WITH 872 00:43:18,080 --> 00:43:24,560 HOW DO WE HANDLE THE LOSS OF 873 00:43:24,560 --> 00:43:25,080 FUNCTION OR THE LOSS OF 874 00:43:25,080 --> 00:43:25,680 BENEFITS WE MAY HAVE ACHIEVED 875 00:43:25,680 --> 00:43:29,800 DURING THE TRIAL? 876 00:43:29,800 --> 00:43:34,120 >> AND FINALLY EXPECTATIONS TO 877 00:43:34,120 --> 00:43:37,800 UNDERSTAND THE RISK AND WE 878 00:43:37,800 --> 00:43:44,800 ALWAYS ASK THE QUESTION AND TO 879 00:43:44,800 --> 00:43:54,680 UNDERSTAND THAT RISK EARLY ON. 880 00:43:54,680 --> 00:43:56,480 BUT WITH THAT UNANTICIPATED 881 00:43:56,480 --> 00:44:06,760 EXPECTATIONS ARE. 882 00:44:07,520 --> 00:44:09,960 AND THAT IS PEPPERED WITH 883 00:44:09,960 --> 00:44:18,120 LINGO ONE —- LEGAL LANGUAGE 884 00:44:18,120 --> 00:44:18,720 AND WHAT THE PATHWAY COULD BE 885 00:44:18,720 --> 00:44:23,640 IN THAT EXPECTATION AND THEN 886 00:44:23,640 --> 00:44:24,240 TO RETAIN THE DEVICE WHAT THAT 887 00:44:24,240 --> 00:44:34,400 MIGHT BE. 888 00:44:38,920 --> 00:44:39,360 AND WITH THOSE IMPLANTED 889 00:44:39,360 --> 00:44:39,880 DEVICES OF TODAY I WENT TO 890 00:44:39,880 --> 00:44:43,520 HIGHLIGHT AND GO BACK TO GO 891 00:44:43,520 --> 00:44:50,680 BACK TO LOSS OF FUNCTION. 892 00:44:50,680 --> 00:44:51,760 AND A YEAR AND A HALF AFTER MY 893 00:44:51,760 --> 00:44:53,880 INJURY TRULY THE INITIAL TRIAL 894 00:44:53,880 --> 00:44:55,280 WAS 18 MONTHS THAT IS WHEN THE 895 00:44:55,280 --> 00:44:56,640 TRIAL WAS OVER WITH. 896 00:44:56,640 --> 00:45:05,920 IF I LOST THE ABILITY I COULD 897 00:45:05,920 --> 00:45:06,480 NOT STAND OR USE ANY OF MY 898 00:45:06,480 --> 00:45:06,880 PARALYZED MUSCLES. 899 00:45:06,880 --> 00:45:07,480 BUT I WAS FORTUNATE ENOUGH TO 900 00:45:07,480 --> 00:45:10,320 BE IN A TRIAL THAT WAS TO THE 901 00:45:10,320 --> 00:45:15,800 CLEVELAND CENTER IN OHIO AND 902 00:45:15,800 --> 00:45:16,560 IT ROLLED INTO A LONG-TERM 903 00:45:16,560 --> 00:45:21,800 FOLLOW-UP STUDY AND I HAVE 904 00:45:21,800 --> 00:45:22,320 BEEN THERE FOR THE LAST 23 905 00:45:22,320 --> 00:45:22,520 YEARS. 906 00:45:22,520 --> 00:45:25,240 OVER THOSE 23 YEARS THEY HAVE 907 00:45:25,240 --> 00:45:25,840 FOLLOWING THE PROGRESSION AND 908 00:45:25,840 --> 00:45:29,960 HOW I USE IT. 909 00:45:29,960 --> 00:45:35,880 AND HOW PEOPLE USE IN SOCIETY 910 00:45:35,880 --> 00:45:45,960 AND HOW IT IS USED IN SOCIETAL 911 00:45:45,960 --> 00:45:52,200 I HAVE BEEN PARALYZED FOUR 912 00:45:52,200 --> 00:45:52,800 TIMES OVER THE PAST FEW YEARS 913 00:45:52,800 --> 00:45:53,400 THAT BECAUSE I AM INVOLVED IN 914 00:45:53,400 --> 00:45:54,400 A LONG-TERM FOLLOW-UP STUDY I 915 00:45:54,400 --> 00:45:58,600 CAN GET RE- IMPLANTED AND IN 916 00:45:58,600 --> 00:45:59,520 SOME CASES UPGRADED TO THE 917 00:45:59,520 --> 00:46:05,520 NEXT LEVEL OF DEVELOPMENT OF 918 00:46:05,520 --> 00:46:08,080 DEVICES. 919 00:46:08,080 --> 00:46:18,560 SO THAT LOSS OF FUNCTION IN 920 00:46:19,080 --> 00:46:19,600 FACT IT HAPPENED VERY RECENTLY 921 00:46:19,600 --> 00:46:23,880 DURING COVID MY SYSTEM FAILED 922 00:46:23,880 --> 00:46:24,400 AND JUST LAST YEAR I WAS 923 00:46:24,400 --> 00:46:25,040 REIMPLANTED SO IF YOU THINK OF 924 00:46:25,040 --> 00:46:28,440 LONG-TERM STUDIES THAT IS 925 00:46:28,440 --> 00:46:29,040 SOMETHING TO CONSIDER AND PUT 926 00:46:29,040 --> 00:46:39,280 ON THE TABLE. 927 00:46:41,480 --> 00:46:49,960 IS A MULTI AGENCY APPROACH. 928 00:46:49,960 --> 00:46:54,240 THERE IS A WORKSHOP TO THROW 929 00:46:54,240 --> 00:47:01,720 SOMETHING AGAINST THE WALL. 930 00:47:01,720 --> 00:47:09,320 AND ALSO LOOKING AT THE FDA. 931 00:47:09,320 --> 00:47:09,920 AND TO HAVE A MINIMAL PLAN IN 932 00:47:09,920 --> 00:47:17,680 THE STUDY. 933 00:47:17,680 --> 00:47:23,120 AND THEN HOW TO ADDRESS THEM 934 00:47:23,120 --> 00:47:30,960 AND WITH THE INCOME TRACKING 935 00:47:30,960 --> 00:47:31,560 AND THEN FUNDING MECHANISMS ON 936 00:47:31,560 --> 00:47:34,920 THE NIH SIDE TO SUPPORT 937 00:47:34,920 --> 00:47:35,440 LONG-TERM STUDIES WITH THE 938 00:47:35,440 --> 00:47:39,880 ADDITIONAL FIVE YEAR RULE WITH 939 00:47:39,880 --> 00:47:40,440 THESE PARTICIPANTS OVER A 940 00:47:40,440 --> 00:47:40,840 PERIOD OF TIME AND 941 00:47:40,840 --> 00:47:45,920 UNDERSTANDING THE EFFECTS BUT 942 00:47:45,920 --> 00:47:50,560 ALSO THE DATA THAT IS PUBLICLY 943 00:47:50,560 --> 00:48:00,960 AVAILABLE AND THERE'S AN 944 00:48:02,040 --> 00:48:04,800 OPPORTUNITY FOR CMS WITH A 945 00:48:04,800 --> 00:48:08,120 TRIAL PARTICIPANT IS A UNIQUE 946 00:48:08,120 --> 00:48:11,160 OPPORTUNITY TO HAVE DATA 947 00:48:11,160 --> 00:48:13,200 ANALYSIS FOR THOSE DECISIONS 948 00:48:13,200 --> 00:48:18,280 THAT YOU CAN USE WITH PAYMENT 949 00:48:18,280 --> 00:48:18,760 AND COVERAGE DECISION. 950 00:48:18,760 --> 00:48:19,360 BUT IT GAINS AN UNDERSTANDING 951 00:48:19,360 --> 00:48:25,120 OF WHAT AND WITH THOSE ADVERSE 952 00:48:25,120 --> 00:48:35,320 ADVANCE MY HAPPEN IT IS JUST 953 00:48:35,320 --> 00:48:35,920 ONE IDEA I WILL NOT CLAIM BUT 954 00:48:35,920 --> 00:48:41,880 I KNOW THE SOLUTION. 955 00:48:41,880 --> 00:48:47,440 AND THEN TO SPEAK WITH YOU AND 956 00:48:47,440 --> 00:48:49,920 THOSE THAT WE RELY ON FOR 957 00:48:49,920 --> 00:48:58,520 TECHNOLOGY. 958 00:48:58,520 --> 00:48:59,080 AND ANY QUESTIONS THAT THEY 959 00:48:59,080 --> 00:49:04,640 MAY HAVE. 960 00:49:04,640 --> 00:49:10,120 >> THANK YOU SO MUCH WE CAN 961 00:49:10,120 --> 00:49:18,040 ALLOW FOR ONE QUESTION. 962 00:49:18,040 --> 00:49:28,440 IS THERE ONE QUESTION. 963 00:49:32,560 --> 00:49:34,000 >> THANK YOU FOR THE 964 00:49:34,000 --> 00:49:35,280 PRESENTATION I HAVE ONE 965 00:49:35,280 --> 00:49:40,160 QUESTION TO FOLLOW UP ON WITH 966 00:49:40,160 --> 00:49:41,640 THE VALUE OF FRAMEWORK 967 00:49:41,640 --> 00:49:47,000 INTEGRATION PRESENTED AND WHAT 968 00:49:47,000 --> 00:49:47,560 TYPE OF ENGAGEMENT YOU THINK 969 00:49:47,560 --> 00:49:52,120 WILL BE MOST VALUABLE DURING 970 00:49:52,120 --> 00:49:53,040 THE PROJECT OF THE INCEPTION 971 00:49:53,040 --> 00:49:53,240 PHASE. 972 00:49:53,240 --> 00:49:54,560 THANK YOU. 973 00:49:54,560 --> 00:49:56,400 >> IT'S A GREAT QUESTION. 974 00:49:56,400 --> 00:50:01,640 I'M A BIG ADVOCATE AND WITH 975 00:50:01,640 --> 00:50:05,960 THAT EVEN IN THE EARLY PROCESS 976 00:50:05,960 --> 00:50:06,560 AND IT WILL ALL DEPEND ON WHAT 977 00:50:06,560 --> 00:50:17,040 YOU ARE DEVELOPING AND ALSO 978 00:50:17,040 --> 00:50:17,960 UNDERSTAND WHAT THE TRIAL MAY 979 00:50:17,960 --> 00:50:22,560 LOOK LIKE AND TO ENGAGEMENT 980 00:50:22,560 --> 00:50:26,680 EARLY ON. 981 00:50:26,680 --> 00:50:29,200 AND WITH THAT CLINICAL 982 00:50:29,200 --> 00:50:34,800 PROCESSES IMPORTANT BECAUSE 983 00:50:34,800 --> 00:50:35,280 AND IF WE HAVE SOMETHING 984 00:50:35,280 --> 00:50:40,720 EXTREMELY IMPRACTICAL IT'S 985 00:50:40,720 --> 00:50:46,560 DIFFICULT TO TRANSLATE THAT. 986 00:50:46,560 --> 00:50:49,080 AND WITH A CONSUMER ADVISORY 987 00:50:49,080 --> 00:50:56,160 BOARD AND THEN TO UNDERSTAND 988 00:50:56,160 --> 00:50:57,400 THOSE PREFERENCES IN THE 989 00:50:57,400 --> 00:50:59,600 PRIORITIES. 990 00:50:59,600 --> 00:51:02,080 I HOPE THAT ANSWERS YOUR 991 00:51:02,080 --> 00:51:02,360 QUESTION? 992 00:51:02,360 --> 00:51:03,280 >> YES. 993 00:51:03,280 --> 00:51:07,400 THANK YOU. 994 00:51:07,400 --> 00:51:17,600 >> AGAIN, Q&A IS OPEN MOVING 995 00:51:17,600 --> 00:51:18,600 ON TO THE THIRD SPEAKER FOR 996 00:51:18,600 --> 00:51:29,120 THIS PANEL ASSISTANT PROFESSOR 997 00:51:30,040 --> 00:51:30,520 AND WITH THE DEPARTMENT OF 998 00:51:30,520 --> 00:51:31,040 PSYCHIATRY TO COMBINE HIS 999 00:51:31,040 --> 00:51:33,120 BACKGROUND IN NEUROSCIENCE AND 1000 00:51:33,120 --> 00:51:34,400 BIOETHICS TO EXAMINE THE 1001 00:51:34,400 --> 00:51:37,240 IMPLICATIONS OF EMERGING BIO 1002 00:51:37,240 --> 00:51:38,760 MEDICAL TECHNOLOGIES IN 1003 00:51:38,760 --> 00:51:40,320 NEUROSCIENCE. 1004 00:51:40,320 --> 00:51:46,120 HIS CURRENT RESEARCH EXAMINES 1005 00:51:46,120 --> 00:51:48,680 WITH DEEP BRAIN STIMULATION 1006 00:51:48,680 --> 00:51:58,440 ASSISTANCE. 1007 00:51:58,440 --> 00:52:08,680 >> THANK YOU. 1008 00:52:09,200 --> 00:52:11,680 AND LOOKING AT POSTTRIAL 1009 00:52:11,680 --> 00:52:17,440 ACCESS. 1010 00:52:17,440 --> 00:52:17,920 AND THANK YOU BRANDY AND 1011 00:52:17,920 --> 00:52:18,520 JENNIFER FOR THEIR WONDERFUL 1012 00:52:18,520 --> 00:52:18,760 THOUGHTS. 1013 00:52:18,760 --> 00:52:19,360 YOU WILL SEE A LOT OF WHAT WE 1014 00:52:19,360 --> 00:52:22,920 ARE SEEING CURRENT TRIAL 1015 00:52:22,920 --> 00:52:28,560 PARTICIPANTS AND WITH THAT 1016 00:52:28,560 --> 00:52:31,040 EXPERIENCE THAT BOTH OF THEM 1017 00:52:31,040 --> 00:52:32,200 HAVE HAD. 1018 00:52:32,200 --> 00:52:36,520 WE HAVE DATA ON RESEARCHERS 1019 00:52:36,520 --> 00:52:39,000 WHERE THEY ASK ABOUT POSTTRIAL 1020 00:52:39,000 --> 00:52:44,720 ACCESS ISSUES. 1021 00:52:44,720 --> 00:52:45,240 AND THEN TO FOCUS ON THE 1022 00:52:45,240 --> 00:52:49,000 PATIENT PERSPECTIVE IN THE 1023 00:52:49,000 --> 00:52:51,400 PROCESS OF LOOKING FOR 1024 00:52:51,400 --> 00:52:52,040 JOURNALS. 1025 00:52:52,040 --> 00:52:58,720 >> AND WITH THAT DEEP BRAIN 1026 00:52:58,720 --> 00:53:09,080 STIMULATION AND THOSE 1027 00:53:12,680 --> 00:53:15,040 ASSOCIATED SYMPTOMS YOU TRY TO 1028 00:53:15,040 --> 00:53:20,360 MANAGE AND THEN TO IDENTIFY TO 1029 00:53:20,360 --> 00:53:22,800 BE ASSOCIATED WITH THE 1030 00:53:22,800 --> 00:53:25,320 SYMPTOMS AND THEN FOR THE 1031 00:53:25,320 --> 00:53:30,960 ONSET AND THEN ACTIVATING THAT 1032 00:53:30,960 --> 00:53:33,160 STIMULATION FOR THAT BRAIN 1033 00:53:33,160 --> 00:53:43,640 ACTIVITY AND FOR EPILEPSY BUT 1034 00:53:46,760 --> 00:53:47,160 THAT CONDITIONS WE ARE 1035 00:53:47,160 --> 00:53:53,480 DISCUSSING NO FDA APPROVAL. 1036 00:53:53,480 --> 00:53:56,360 SO WE INTERVIEWED THESE 1037 00:53:56,360 --> 00:54:00,680 PATIENTS BEFORE THE SURGERY. 1038 00:54:00,680 --> 00:54:02,960 WE ASKED THEM QUESTIONS ABOUT 1039 00:54:02,960 --> 00:54:07,240 POSTTRIAL DISCUSSIONS AND THEN 1040 00:54:07,240 --> 00:54:11,040 WE ASKED THEM SIX MONTHS LATER 1041 00:54:11,040 --> 00:54:19,040 WHAT TO DO REMEMBER? 1042 00:54:19,040 --> 00:54:19,640 AND THEY WERE PARTICIPATING IN 1043 00:54:19,640 --> 00:54:21,640 PARKINSON'S DISEASE TRIALS AND 1044 00:54:21,640 --> 00:54:26,960 TOURETTE SYNDROME. 1045 00:54:26,960 --> 00:54:28,480 SO WITH THE METHODS WE HAVE 21 1046 00:54:28,480 --> 00:54:35,360 PARTICIPANTS AND ALL 1047 00:54:35,360 --> 00:54:35,920 TRANSCRIPT WERE RECORDED BY 1048 00:54:35,920 --> 00:54:36,520 MEMBERS OF THE RESEARCH TEAM 1049 00:54:36,520 --> 00:54:39,560 AND WITH THOSE EXTRACTIONS AND 1050 00:54:39,560 --> 00:54:41,080 THEN TO EXTRACT THE THEME 1051 00:54:41,080 --> 00:54:45,240 COMING FROM THE DATA WE ALSO 1052 00:54:45,240 --> 00:54:45,800 HAVE AT LEAST TWO MEMBERS 1053 00:54:45,800 --> 00:54:51,520 LOOKING AT IDENTIFYING AND 1054 00:54:51,520 --> 00:55:02,000 THAT IS EMERGING SO WHAT IF 1055 00:55:03,440 --> 00:55:11,560 ANYTHING THROUGH THE TRIAL. 1056 00:55:11,560 --> 00:55:16,560 AND THE RESPONSES WERE NOT 1057 00:55:16,560 --> 00:55:16,920 VERY DETAILED. 1058 00:55:16,920 --> 00:55:20,320 SO WE LOWER THAT THRESHOLD SO 1059 00:55:20,320 --> 00:55:23,280 DO THEY HAVE ANY RECOLLECTION 1060 00:55:23,280 --> 00:55:25,840 OF HAVING DISCUSSED THIS OR 1061 00:55:25,840 --> 00:55:33,280 NOT? 1062 00:55:33,280 --> 00:55:33,880 AND AFTER THE CONSENT PROCESS 1063 00:55:33,880 --> 00:55:34,440 EIGHT OF THEM SAID THEY DID 1064 00:55:34,440 --> 00:55:37,880 NOT RECALL DISCUSSING THE 1065 00:55:37,880 --> 00:55:46,040 ISSUE EIGHT OF THEM DID SAY 1066 00:55:46,040 --> 00:55:46,560 THEY RECALL DISCUSSING THE 1067 00:55:46,560 --> 00:55:47,760 ISSUE AND FIVE OF THEM WERE 1068 00:55:47,760 --> 00:55:55,000 NOT VERY CLEAR SO ONE EXAMPLE 1069 00:55:55,000 --> 00:55:57,000 OF NO RECOLLECTION I DON'T 1070 00:55:57,000 --> 00:55:59,560 REMEMBER OR HAVING THAT 1071 00:55:59,560 --> 00:56:02,320 DISCUSSION. 1072 00:56:02,320 --> 00:56:04,880 SO NOW SIX MONTHS AFTER THE 1073 00:56:04,880 --> 00:56:07,040 SURGERY, POST SURGERY WE ASKED 1074 00:56:07,040 --> 00:56:09,400 AGAIN DO YOU REMEMBER HAVING 1075 00:56:09,400 --> 00:56:15,800 DISCUSSED THIS WITH THE TEAM? 1076 00:56:15,800 --> 00:56:16,400 SEVEN OF THEM SAID THEY STILL 1077 00:56:16,400 --> 00:56:21,120 DID NOT REMEMBER DISCUSSING. 1078 00:56:21,120 --> 00:56:27,400 'S YOU HAVE AN ISSUE HERE THE 1079 00:56:27,400 --> 00:56:27,960 UNETHICAL ISSUE OF CONSENT 1080 00:56:27,960 --> 00:56:29,800 WHERE MANY OF THE PARTICIPANTS 1081 00:56:29,800 --> 00:56:32,640 MAY BE UNDERGOING THE SURGERY 1082 00:56:32,640 --> 00:56:35,200 AND NOT NECESSARILY KNOW OR AT 1083 00:56:35,200 --> 00:56:41,240 LEAST IT WAS DISCUSSED IN THE 1084 00:56:41,240 --> 00:56:41,840 CONSENT PROCESS BUT THERE IS A 1085 00:56:41,840 --> 00:56:42,520 LOT GOING ON BUT THEY DON'T 1086 00:56:42,520 --> 00:56:45,320 RECALL HAVING DISCUSSED THE 1087 00:56:45,320 --> 00:56:51,320 ISSUES SO ONE EXAMPLE IS THAT 1088 00:56:51,320 --> 00:56:55,840 I CANNOT AFFORD THE NEW DEVICE 1089 00:56:55,840 --> 00:56:57,160 OR THE BATTERY OR WHAT IS 1090 00:56:57,160 --> 00:57:01,800 RECHARGEABLE ONE PARTICIPANT 1091 00:57:01,800 --> 00:57:02,400 IN THE SIX-MONTH POST SURGERY 1092 00:57:02,400 --> 00:57:04,200 INTERVIEWS SAID IT WAS FUNNY 1093 00:57:04,200 --> 00:57:09,920 BECAUSE AND THEN TO SAY THIS 1094 00:57:09,920 --> 00:57:12,080 QUESTION CAME UP ABOUT 1095 00:57:12,080 --> 00:57:16,520 BIOETHICS AND END OF TRIAL. 1096 00:57:16,520 --> 00:57:17,120 HOW DO YOU FEEL ABOUT ME IT'S 1097 00:57:17,120 --> 00:57:23,440 ON —- ASKING THAT QUESTION SO 1098 00:57:23,440 --> 00:57:24,040 THE PATIENT IS THEY ARE ABOUT 1099 00:57:24,040 --> 00:57:27,440 TO HAVE THE SURGERY AND THEN 1100 00:57:27,440 --> 00:57:28,800 REMEMBERS HE HAD THIS 1101 00:57:28,800 --> 00:57:33,400 DISCUSSION AND ONE OF THOSE 1102 00:57:33,400 --> 00:57:42,040 RESEARCH ASSISTANTS AND THEN 1103 00:57:42,040 --> 00:57:42,640 TO FEEL SOMEWHAT UNCOMFORTABLE 1104 00:57:42,640 --> 00:57:48,680 AT THAT MOMENT. 1105 00:57:48,680 --> 00:57:56,120 SO DO YOU THINK THEY SHOULD 1106 00:57:56,120 --> 00:58:00,520 WHAT SHOULD HAPPEN TO THE 1107 00:58:00,520 --> 00:58:04,840 DEVICE? 1108 00:58:04,840 --> 00:58:08,680 AND THEN 76 PERCENT SAID THEY 1109 00:58:08,680 --> 00:58:13,320 SHOULD KEEP THE DEVICE AND 1110 00:58:13,320 --> 00:58:15,360 HOPING IT WOULD PROVIDE AND 1111 00:58:15,360 --> 00:58:21,080 KEEPING IT. 1112 00:58:21,080 --> 00:58:23,560 AND THEY WERE NOT PROVIDE 1113 00:58:23,560 --> 00:58:29,080 THOSE ANSWERS AND WITH THAT 1114 00:58:29,080 --> 00:58:32,680 RESPONSE WAS 76 PERCENT FOR 1115 00:58:32,680 --> 00:58:36,960 MOST OF THEM AND THEY SAID WE 1116 00:58:36,960 --> 00:58:44,160 SHOULD BE ABOUT TO KEEP IT SO 1117 00:58:44,160 --> 00:58:45,040 81 PERCENT SAID THEY SHOULD BE 1118 00:58:45,040 --> 00:58:47,600 ABLE TO KEEP IT TOGETHER SAID 1119 00:58:47,600 --> 00:58:51,960 IT WAS UNCLEAR IF IT IS STILL 1120 00:58:51,960 --> 00:58:53,280 WORKING AND THEY HAVE TO FIGHT 1121 00:58:53,280 --> 00:58:59,920 ME FOR IT. 1122 00:58:59,920 --> 00:59:01,200 AND SO THEN THEY FEEL VERY 1123 00:59:01,200 --> 00:59:03,520 STRONGLY THEY WANT TO KEEP 1124 00:59:03,520 --> 00:59:09,440 USING THESE DEVICES AS IT WAS 1125 00:59:09,440 --> 00:59:16,960 BROUGHT UP THEY TRIED MANY 1126 00:59:16,960 --> 00:59:17,880 DIFFERENT TREATMENTS THAT ARE 1127 00:59:17,880 --> 00:59:18,880 FDA APPROVED BUT NOTHING HAS 1128 00:59:18,880 --> 00:59:25,320 WORKED WELL FOR THEM SO WHEN 1129 00:59:25,320 --> 00:59:25,920 THEY DO FIND SOMETHING THAT IS 1130 00:59:25,920 --> 00:59:27,840 WORKING THEY FEEL VERY 1131 00:59:27,840 --> 00:59:30,560 STRONGLY. 1132 00:59:30,560 --> 00:59:35,040 SO HOW DO YOU KEEPING 1133 00:59:35,040 --> 00:59:35,640 THE DEVICE FUNCTIONING AT THE 1134 00:59:35,640 --> 00:59:36,200 END OF THE STUDY SHOULD BE 1135 00:59:36,200 --> 00:59:39,720 PAID FOR? 1136 00:59:39,720 --> 00:59:40,720 AND INTERESTINGLY DURING THE 1137 00:59:40,720 --> 00:59:43,960 PRESURGERY INTERVIEW MOST 1138 00:59:43,960 --> 00:59:45,480 MENTIONED INSURANCE WHICH IS 1139 00:59:45,480 --> 00:59:46,280 REASONABLE. 1140 00:59:46,280 --> 00:59:50,840 FROM THEIR PERSPECTIVE ALSO 1141 00:59:50,840 --> 00:59:51,360 FOR RESEARCHERS IF IT IS 1142 00:59:51,360 --> 00:59:56,360 WORKING FOR THEM FOR A PERSON 1143 00:59:56,360 --> 00:59:57,840 THAT DOES NOT HAVE OTHER MID- 1144 00:59:57,840 --> 01:00:01,880 ON —- MEDICATIONS IF IT IS 1145 01:00:01,880 --> 01:00:03,720 WORKING FOR THEM THEN IT 1146 01:00:03,720 --> 01:00:04,280 BECOMES MEDICALLY NECESSARY 1147 01:00:04,280 --> 01:00:14,760 FOR THE INDIVIDUAL AND THEN 1148 01:00:15,440 --> 01:00:19,200 SHOULD ALLOW THIS FOR 1149 01:00:19,200 --> 01:00:25,240 INSURANCE PROVIDERS AND WITH 1150 01:00:25,240 --> 01:00:30,840 THE COST ASSOCIATED WITH THIS. 1151 01:00:30,840 --> 01:00:31,880 BECAUSE THIS COULD STILL BE 1152 01:00:31,880 --> 01:00:35,680 VERY EXPENSIVE FOR 1153 01:00:35,680 --> 01:00:38,080 PARTICIPANTS TO MANAGE THE 1154 01:00:38,080 --> 01:00:42,360 OTHER CALLS THAT ARE NOT 1155 01:00:42,360 --> 01:00:46,680 COVERED BY INSURANCE BUT SIX 1156 01:00:46,680 --> 01:00:49,280 MONTHS INTO THE SURGERY AND 1157 01:00:49,280 --> 01:00:54,480 THE DEVICE THAT MENTIONS 1158 01:00:54,480 --> 01:00:55,360 BASICALLY WHAT WE ARE 1159 01:00:55,360 --> 01:01:00,680 PRESENTING HERE AND THEN THEY 1160 01:01:00,680 --> 01:01:04,520 COULD MENTION MORE THAN ONE TO 1161 01:01:04,520 --> 01:01:06,360 HAVE SOME RESPONSIBILITY FOR 1162 01:01:06,360 --> 01:01:13,680 COVERING THE COST SO WE SEE A 1163 01:01:13,680 --> 01:01:14,200 DECREASE IN THE NUMBER OF 1164 01:01:14,200 --> 01:01:16,080 MENTIONS OF INSURANCE 1165 01:01:16,080 --> 01:01:17,760 PROVIDERS AND WHAT WE SEE IS 1166 01:01:17,760 --> 01:01:18,320 THERE IS AN INCREASE OF THE 1167 01:01:18,320 --> 01:01:23,360 NUMBER OF PEOPLE WITH DEVICE 1168 01:01:23,360 --> 01:01:27,600 MANUFACTURERS. 1169 01:01:27,600 --> 01:01:28,120 SO DURING THE PROCESS THEY 1170 01:01:28,120 --> 01:01:31,080 UNDERSTAND THE TRIAL PROCESS 1171 01:01:31,080 --> 01:01:32,120 AND THE DATA COLLECTED AND I 1172 01:01:32,120 --> 01:01:36,680 WILL MENTION SOME OF THE 1173 01:01:36,680 --> 01:01:41,640 ISSUES. 1174 01:01:41,640 --> 01:01:45,720 AND THEY WOULD SAY THEY HAVE 1175 01:01:45,720 --> 01:01:47,320 RESPONSIBILITY. 1176 01:01:47,320 --> 01:01:49,600 THEY MENTIONED THE RESEARCH 1177 01:01:49,600 --> 01:01:53,480 TEAM WHERE IT IS TAKING PLACE 1178 01:01:53,480 --> 01:01:56,440 AND SO FOR EXAMPLE THIS IS AN 1179 01:01:56,440 --> 01:02:00,960 EXAMPLE OF THE RATIONALE FOR 1180 01:02:00,960 --> 01:02:01,960 DEVICE MANUFACTURERS. 1181 01:02:01,960 --> 01:02:04,680 SINCE THE COMPANY OR THE TEAM 1182 01:02:04,680 --> 01:02:09,880 OR WHATEVER THEY DO HAVE A 1183 01:02:09,880 --> 01:02:10,440 RESPONSIBILITY TO CARE FOR 1184 01:02:10,440 --> 01:02:12,280 THEIR PEOPLE THAT HAVE THESE 1185 01:02:12,280 --> 01:02:13,920 DEVICES I WOULD NOT WANT TO BE 1186 01:02:13,920 --> 01:02:19,880 CUT LOOSE THERE ARE THINGS 1187 01:02:19,880 --> 01:02:20,400 HERE ABOUT RECIPROCITY AND 1188 01:02:20,400 --> 01:02:24,520 GETTING INFORMATION FROM THIS 1189 01:02:24,520 --> 01:02:34,000 RESEARCH AND THEN THE OTHER 1190 01:02:34,000 --> 01:02:34,560 PERSON THAT IS IMPORTANT TO 1191 01:02:34,560 --> 01:02:41,560 KEEP IN MIND SO ONE EXAMPLE IS 1192 01:02:41,560 --> 01:02:42,800 INSURANCE SHOULD PAY IS 1193 01:02:42,800 --> 01:02:43,400 SOMETHING THEY SHOULD HAVE TO 1194 01:02:43,400 --> 01:02:47,520 PAY FOR THE STUDY I THINK THEY 1195 01:02:47,520 --> 01:02:48,880 SHOULD TAKE SOME 1196 01:02:48,880 --> 01:02:50,960 RESPONSIBILITY AND IF THEY 1197 01:02:50,960 --> 01:02:51,920 JUST PAT WHAT THEY ARE 1198 01:02:51,920 --> 01:02:57,800 SUPPOSED TO DO THEN THEY SEE 1199 01:02:57,800 --> 01:03:00,800 THIS HAVING A LOT OF 1200 01:03:00,800 --> 01:03:03,360 EXPERIENCE TO GET INSURANCE TO 1201 01:03:03,360 --> 01:03:06,000 COVER THE DIFFERENT TREATMENTS 1202 01:03:06,000 --> 01:03:06,600 THAT THEY HAVE TRIED THAT HAVE 1203 01:03:06,600 --> 01:03:14,080 NOT WORKED FOR THEM BUT THIS 1204 01:03:14,080 --> 01:03:15,040 IS THE OBLIGATION WITH THE 1205 01:03:15,040 --> 01:03:19,680 INSURANCE PROVIDER SO THE 1206 01:03:19,680 --> 01:03:20,280 DEVICE HAS TO BECOME MEDICALLY 1207 01:03:20,280 --> 01:03:22,440 NECESSARY FOR THE PATIENT EVEN 1208 01:03:22,440 --> 01:03:29,680 THOUGH IT IS EXPERIMENTAL. 1209 01:03:29,680 --> 01:03:33,440 IF YOU CAN AFFORD IT THEN YOU 1210 01:03:33,440 --> 01:03:34,040 SHOULD PAY THE MAINTENANCE BUT 1211 01:03:34,040 --> 01:03:36,520 IF YOU CAN'T THE SAME WAY I 1212 01:03:36,520 --> 01:03:37,120 GOT INTO THE STUDY IS THE WAY 1213 01:03:37,120 --> 01:03:45,720 IT SHOULD BE. 1214 01:03:45,720 --> 01:03:48,240 BUT IT'S MORE THAN A FEW 1215 01:03:48,240 --> 01:03:49,080 PENNIES. 1216 01:03:49,080 --> 01:03:52,040 SO IT IS A FEAR THAT THE 1217 01:03:52,040 --> 01:03:55,360 COMPASSION THERE IS A MEDICAL 1218 01:03:55,360 --> 01:03:57,880 NEED THAT CANNOT BE MET 1219 01:03:57,880 --> 01:04:01,240 OTHERWISE SO EVEN IF THERE IS 1220 01:04:01,240 --> 01:04:05,400 A COST ASSOCIATED WITH THIS TO 1221 01:04:05,400 --> 01:04:07,960 FIGURE OUT A WAY TO MAKE IT 1222 01:04:07,960 --> 01:04:12,200 AVAILABLE IN CASE THEY CANNOT 1223 01:04:12,200 --> 01:04:15,200 AFFORD IT BUT ONE EXAMPLE AS 1224 01:04:15,200 --> 01:04:18,840 WELL THE STUDY SHOULD PAY FOR 1225 01:04:18,840 --> 01:04:21,400 IT THE PARTICIPANTS TOOK THE 1226 01:04:21,400 --> 01:04:25,680 RISK AND WHATEVER WAS NEEDED 1227 01:04:25,680 --> 01:04:26,720 TO BE PAID FOR BY THE 1228 01:04:26,720 --> 01:04:30,960 INDIVIDUAL PERSON IF THEY 1229 01:04:30,960 --> 01:04:31,520 CANNOT PAY THAN IT SHOULD BE 1230 01:04:31,520 --> 01:04:33,880 TAKEN CARE OF BY THE STUDY 1231 01:04:33,880 --> 01:04:36,520 EVEN WHEN THE STUDY ENDS ONE 1232 01:04:36,520 --> 01:04:40,040 EXAMPLE IS THERE IS A LIE THE 1233 01:04:40,040 --> 01:04:40,560 TIME AND EFFORT HAD TO GO 1234 01:04:40,560 --> 01:04:42,560 THROUGH BRAIN SURGERY I HAVE 1235 01:04:42,560 --> 01:04:47,240 TO COME IN EVERY TWO WEEKS AND 1236 01:04:47,240 --> 01:04:47,800 THAT TAKES UP THE WHOLE DAY 1237 01:04:47,800 --> 01:04:49,600 EVERY TWO WEEKS AND THEN EVERY 1238 01:04:49,600 --> 01:04:53,240 MONTH AND IT IS VERY TIME 1239 01:04:53,240 --> 01:04:54,680 CONSUMING SO WE SEE THAT 1240 01:04:54,680 --> 01:04:56,000 RECIPROCITY AND THEN 1241 01:04:56,000 --> 01:04:59,360 COMPASSION TO TAKE REASONABLE 1242 01:04:59,360 --> 01:05:02,880 STEPS TO MANAGE A NEED THAT 1243 01:05:02,880 --> 01:05:06,400 CANNOT BE MET OTHERWISE. 1244 01:05:06,400 --> 01:05:11,920 >> THANK YOU TO OUR 1245 01:05:11,920 --> 01:05:18,360 COLLABORATORS FROM THE BRAIN 1246 01:05:18,360 --> 01:05:28,560 RESEARCH. 1247 01:05:30,080 --> 01:05:35,080 >> WE HAVE TIME AGAIN FOR ONE 1248 01:05:35,080 --> 01:05:44,960 QUESTION. 1249 01:05:44,960 --> 01:05:46,000 >> THERE IS THE QUESTION IN 1250 01:05:46,000 --> 01:05:50,880 THE CHAT IF THE SUBJECTS IN 1251 01:05:50,880 --> 01:05:53,800 YOUR RESEARCH OR THE INDUSTRY 1252 01:05:53,800 --> 01:05:54,280 OR GOVERNMENT SPONSORED 1253 01:05:54,280 --> 01:05:58,160 STUDIES ARE BOTH? 1254 01:05:58,160 --> 01:06:04,240 >> MOSTLY GOVERNMENT-SPONSORED 1255 01:06:04,240 --> 01:06:08,200 BS MOSTLY GOVERNMENT. 1256 01:06:08,200 --> 01:06:13,760 >> NOW MOVING ON TO THE LAST 1257 01:06:13,760 --> 01:06:18,200 SPEAKER FOR THIS PANEL YOU CAN 1258 01:06:18,200 --> 01:06:23,160 CONTINUE TO ASK QUESTIONS FOR 1259 01:06:23,160 --> 01:06:24,160 THE PANEL DISCUSSION SO THE 1260 01:06:24,160 --> 01:06:27,000 LAST SPEAKER IS DOCTOR JAMES 1261 01:06:27,000 --> 01:06:29,280 MAHONEY AN ASSISTANT PROFESSOR 1262 01:06:29,280 --> 01:06:33,040 AND CLINICAL NEUROPSYCHOLOGIST 1263 01:06:33,040 --> 01:06:33,640 DEPARTMENT BEHAVIORAL MEDICINE 1264 01:06:33,640 --> 01:06:38,480 AND PSYCHIATRY AT WEST 1265 01:06:38,480 --> 01:06:39,080 VIRGINIA UNIVERSITY SCHOOL OF 1266 01:06:39,080 --> 01:06:39,360 MEDICINE. 1267 01:06:39,360 --> 01:06:41,720 HE ALSO SERVES AS DIRECTOR OF 1268 01:06:41,720 --> 01:06:46,480 INFECTIONS RESEARCH. 1269 01:06:46,480 --> 01:06:46,920 IS INTERESTING TO THE 1270 01:06:46,920 --> 01:06:48,120 INVESTIGATION OF NARROW 1271 01:06:48,120 --> 01:06:52,360 PSYCHOLOGICAL ISSUES WITH 1272 01:06:52,360 --> 01:06:52,960 SUBSTANCE USE DISORDER AS WELL 1273 01:06:52,960 --> 01:06:53,760 AS INVESTIGATIONS OF NOVEL 1274 01:06:53,760 --> 01:06:55,760 TREATMENTS INVOLVING 1275 01:06:55,760 --> 01:06:59,720 NEUROMODULATION WITH SUBSTANCE 1276 01:06:59,720 --> 01:07:00,280 DISORDER SUCH AS DEEP BRAIN 1277 01:07:00,280 --> 01:07:01,320 STIMULATION AND FOCUSED 1278 01:07:01,320 --> 01:07:04,400 ULTRASOUND AND MAGNETIC 1279 01:07:04,400 --> 01:07:07,120 STIMULATION. 1280 01:07:07,120 --> 01:07:08,760 >> THANK YOU FOR THAT 1281 01:07:08,760 --> 01:07:18,040 INTRODUCTION. 1282 01:07:18,040 --> 01:07:21,360 SO THANK YOU FOR THE 1283 01:07:21,360 --> 01:07:26,440 INVITATION TO SPEAK AND IT'S 1284 01:07:26,440 --> 01:07:28,920 GOOD TO SEE THERE IS A LOT OF 1285 01:07:28,920 --> 01:07:37,520 OVERLAP AND WHEN IT COMES TO 1286 01:07:37,520 --> 01:07:46,240 ENSURING THOSE NEEDS ARE MET 1287 01:07:46,240 --> 01:07:47,760 LOOKING IN THE DEEP BRAIN 1288 01:07:47,760 --> 01:07:53,520 STIMULATION FOR OPIOID USE 1289 01:07:53,520 --> 01:07:58,080 DISORDER SOMEONE WITH 1290 01:07:58,080 --> 01:08:02,560 ADDICTION AND SUBSTANCE ABUSE 1291 01:08:02,560 --> 01:08:03,160 DISORDER THE FIRST INVASIVE 1292 01:08:03,160 --> 01:08:06,600 TRIAL I WAS INVOLVED IN WE HAD 1293 01:08:06,600 --> 01:08:13,960 THIS PROPOSAL SO IT WAS VERY 1294 01:08:13,960 --> 01:08:24,280 WELL THOUGHT OUT. 1295 01:08:25,240 --> 01:08:26,680 AND WITH THAT MEDICATION 1296 01:08:26,680 --> 01:08:34,520 DEVELOPMENT THERE ISN'T AS 1297 01:08:34,520 --> 01:08:39,520 MUCH POSTTRIAL THEY ARE NOT AS 1298 01:08:39,520 --> 01:08:42,880 EXTENSIVE AS THE STUDY IT IS A 1299 01:08:42,880 --> 01:08:46,800 GOOD OPPORTUNITY WITH THE 1300 01:08:46,800 --> 01:08:52,040 SURGICAL TEAM ESPECIALLY. 1301 01:08:52,040 --> 01:08:52,600 AND THOSE WHO JOINED US HERE 1302 01:08:52,600 --> 01:08:58,760 IN WEST VIRGINIA UNIVERSITY 1303 01:08:58,760 --> 01:08:59,360 AND THOSE WHO HAVE BEEN DOING 1304 01:08:59,360 --> 01:09:06,600 THE DBS TRIALS. 1305 01:09:06,600 --> 01:09:10,360 BECAUSE THAT IS SOMETHING FROM 1306 01:09:10,360 --> 01:09:13,720 THE ONSET FOR WHEN THE STUDIES 1307 01:09:13,720 --> 01:09:17,240 ARE OVER, THEY ARE NOT OVER 1308 01:09:17,240 --> 01:09:19,800 AND THEN TO IMPACT DIFFERENT 1309 01:09:19,800 --> 01:09:22,360 METHODS TO ENSURE THE 1310 01:09:22,360 --> 01:09:26,400 PARTICIPANTS IN THE PATIENT'S 1311 01:09:26,400 --> 01:09:32,480 THAT THAT COMES FIRST. 1312 01:09:32,480 --> 01:09:37,800 SO SOME OF THOSE SPECIFIC ONES 1313 01:09:37,800 --> 01:09:40,240 REGARDING HARDWARE REPLACEMENT 1314 01:09:40,240 --> 01:09:43,160 IN THE FALSE GENERATOR 1315 01:09:43,160 --> 01:09:46,920 REPLACEMENT HAS TO OCCUR. 1316 01:09:46,920 --> 01:09:50,800 THE CURRENT STUDY I WAS 1317 01:09:50,800 --> 01:09:53,600 DISCUSSING HAS A 52 WEEK 1318 01:09:53,600 --> 01:09:56,840 PRIMARY COMPONENT AND THEN 1319 01:09:56,840 --> 01:09:57,800 WITH AN EXTENDED FOLLOW-UP 1320 01:09:57,800 --> 01:10:00,280 OVER FIVE YEARS. 1321 01:10:00,280 --> 01:10:03,840 SO THAT GIVES US THE ABILITY 1322 01:10:03,840 --> 01:10:07,040 BUT CLINICALLY BUT JUST 1323 01:10:07,040 --> 01:10:07,600 RESEARCH PURPOSES AS WELL IN 1324 01:10:07,600 --> 01:10:09,600 MY THAT'S IMPORTANT. 1325 01:10:09,600 --> 01:10:12,400 AND DEVICE MAINTENANCE TO 1326 01:10:12,400 --> 01:10:17,760 FOLLOW THE'S INDIVIDUALS FROM 1327 01:10:17,760 --> 01:10:22,080 WHEN THE PROTOCOL AND JUST 1328 01:10:22,080 --> 01:10:23,080 MAKE SURE THE DEVICE IS 1329 01:10:23,080 --> 01:10:27,040 WORKING PROPERLY AND THEN ALSO 1330 01:10:27,040 --> 01:10:31,960 SIDE EFFECT MANAGEMENT THAT 1331 01:10:31,960 --> 01:10:34,280 DOESN'T AND WHEN THE STUDY 1332 01:10:34,280 --> 01:10:35,080 ENDS. 1333 01:10:35,080 --> 01:10:41,080 C HAVE TO CONTINUE TO KNOW THE 1334 01:10:41,080 --> 01:10:49,000 SAFETY IS AT THE FOREFRONT. 1335 01:10:49,000 --> 01:10:49,360 LOOKING AT THE 1336 01:10:49,360 --> 01:10:49,920 RESPONSIBILITIES ASSUMED BY 1337 01:10:49,920 --> 01:10:53,160 THE INVESTIGATIVE TEAM THEY 1338 01:10:53,160 --> 01:10:54,120 NEED TO BE CONSIDERED VERY 1339 01:10:54,120 --> 01:10:58,400 EARLY ON FROM THAT PROPOSAL IN 1340 01:10:58,400 --> 01:11:01,160 THE PROTOCOLS DEVELOPED HOW DO 1341 01:11:01,160 --> 01:11:04,960 YOU SET FUNDING SOURCES THESE 1342 01:11:04,960 --> 01:11:05,920 ARE DISCUSSED IN THE 1343 01:11:05,920 --> 01:11:07,800 APPLICATION PROCESS AND HOW 1344 01:11:07,800 --> 01:11:12,680 WILL THE POST CARE TRIAL 1345 01:11:12,680 --> 01:11:16,800 COMPLETION AND THEN THE 1346 01:11:16,800 --> 01:11:20,320 PARTICIPANT WITH THE CONSENT 1347 01:11:20,320 --> 01:11:24,760 PROCESS TO MAKE SURE IT IS AS 1348 01:11:24,760 --> 01:11:25,320 INFORMED AS POSSIBLE WORKING 1349 01:11:25,320 --> 01:11:28,440 WITH INDIVIDUALS WITH 1350 01:11:28,440 --> 01:11:29,480 ADDICTION BECAUSE THERE IS 1351 01:11:29,480 --> 01:11:35,360 ANXIETY AROUND DAY TODAY AND 1352 01:11:35,360 --> 01:11:37,680 THE CLINIC LET ALONE THE 1353 01:11:37,680 --> 01:11:38,600 UNCERTAINTY FOR WHEN THE TRIAL 1354 01:11:38,600 --> 01:11:42,240 IS OVER HOW DO I MAKE SURE I 1355 01:11:42,240 --> 01:11:44,480 AM TAKEN CARE OF AND THEN TO 1356 01:11:44,480 --> 01:11:47,040 DISCUSS WITH THE FOLLOW-UP 1357 01:11:47,040 --> 01:11:52,080 CARE WILL LOOK LIKE AND GOING 1358 01:11:52,080 --> 01:11:55,960 FORWARD WITH CONSENTING AND TO 1359 01:11:55,960 --> 01:12:01,440 BE COMPLETELY TRANSPARENT AND 1360 01:12:01,440 --> 01:12:08,840 THEN THE INVESTIGATIVE TEAM 1361 01:12:08,840 --> 01:12:11,440 THAT CAN HELP YOU BRIDGE THE 1362 01:12:11,440 --> 01:12:17,040 COST AND THEN THE ULTIMATE 1363 01:12:17,040 --> 01:12:20,360 GOAL MOVES TOWARDS FDA 1364 01:12:20,360 --> 01:12:23,720 APPROVAL AND THEN HOPEFULLY IT 1365 01:12:23,720 --> 01:12:24,320 COVERS SOME OF THOSE COSTS BUT 1366 01:12:24,320 --> 01:12:24,840 WHAT CAN BE DONE IN THE 1367 01:12:24,840 --> 01:12:30,640 MEANTIME BEFORE THAT HAPPENS? 1368 01:12:30,640 --> 01:12:32,160 SO IT'S NOT JUST THE 1369 01:12:32,160 --> 01:12:34,400 INVESTIGATOR IT IS A 1370 01:12:34,400 --> 01:12:35,720 COLLABORATIVE EFFORT 1371 01:12:35,720 --> 01:12:37,200 UNIVERSITY OF HEALTHCARE 1372 01:12:37,200 --> 01:12:40,760 INSTITUTIONS WITH THOSE 1373 01:12:40,760 --> 01:12:41,240 INSURANCE PROVIDERS AND 1374 01:12:41,240 --> 01:12:42,440 INDUSTRY PARTNERS AS WELL 1375 01:12:42,440 --> 01:12:45,440 FUNDING THE AGENCIES THROUGH 1376 01:12:45,440 --> 01:12:52,920 PRIVATE DONORS WHEN THE 1377 01:12:52,920 --> 01:12:53,920 INVESTIGATIVE TEAM IS 1378 01:12:53,920 --> 01:12:59,560 DEVELOPING PLANS OF HOW THEY 1379 01:12:59,560 --> 01:13:00,160 WILL BE FINANCIALLY SUPPORTED 1380 01:13:00,160 --> 01:13:03,280 YOU ARE LOOKING AT ALL THE 1381 01:13:03,280 --> 01:13:07,320 OPTIONS. 1382 01:13:07,320 --> 01:13:08,400 AND THEN TO MAKE SURE WITH THE 1383 01:13:08,400 --> 01:13:10,880 FINANCIAL BURDEN WHETHER 1384 01:13:10,880 --> 01:13:16,440 ADDITIONAL STAFFING NEEDS AND 1385 01:13:16,440 --> 01:13:19,000 TO MAKE SURE THOSE NEEDS ARE 1386 01:13:19,000 --> 01:13:23,480 MET. 1387 01:13:23,480 --> 01:13:26,040 ALSO SEPARATING OUT CLINICAL 1388 01:13:26,040 --> 01:13:30,040 NEED AND FOR THOSE DEVICE 1389 01:13:30,040 --> 01:13:32,920 TRIALS WITH THAT DEEP BRAIN 1390 01:13:32,920 --> 01:13:37,520 STIMULATION THAT DBS WILL 1391 01:13:37,520 --> 01:13:38,360 REPLACE ALL OF THEIR OTHER 1392 01:13:38,360 --> 01:13:39,160 CLINICAL TREATMENT. 1393 01:13:39,160 --> 01:13:43,400 WE DON'T THINK THAT THAT IT 1394 01:13:43,400 --> 01:13:46,000 WILL JUST FLIP THE ADDICTION 1395 01:13:46,000 --> 01:13:47,160 SWITCH AND NOW THEY NO LONGER 1396 01:13:47,160 --> 01:13:51,720 NEED THERE BE. 1397 01:13:51,720 --> 01:13:54,280 LOOKING AT IT AS A CONJUNCTIVE 1398 01:13:54,280 --> 01:13:57,680 TREATMENT THIS IS JUST ANOTHER 1399 01:13:57,680 --> 01:14:00,920 TOOL IN THE TOOLBOX WITH THE 1400 01:14:00,920 --> 01:14:03,880 STANDARD LEVEL OF CARE. 1401 01:14:03,880 --> 01:14:07,360 BUT IS JUST MEANT TO AUGMENT 1402 01:14:07,360 --> 01:14:09,720 THE TREATMENT THEY ARE ALREADY 1403 01:14:09,720 --> 01:14:20,240 GETTING AND THEN ALSO AND THEN 1404 01:14:21,040 --> 01:14:26,680 THOSE INVESTIGATORS AND THEN 1405 01:14:26,680 --> 01:14:32,560 TO RELOCATE AND RETIRE. 1406 01:14:32,560 --> 01:14:33,080 AND THEN TO ENSURE THAT 1407 01:14:33,080 --> 01:14:36,040 INDIVIDUAL CAN CONTINUE. 1408 01:14:36,040 --> 01:14:40,400 TALKING SPECIFICALLY WITH THAT 1409 01:14:40,400 --> 01:14:42,800 DEEP BRAIN STIMULATION 1410 01:14:42,800 --> 01:14:46,400 PROTOCOL WE SAT DOWN AND ARE 1411 01:14:46,400 --> 01:14:48,720 WRITING UP THE INITIAL 1412 01:14:48,720 --> 01:14:52,640 PROPOSAL AND WE ARE DEFINITELY 1413 01:14:52,640 --> 01:14:53,240 CONSIDERING WHAT WILL BE DONE 1414 01:14:53,240 --> 01:14:56,440 WITH THAT ONE YEAR FOLLOW-UP 1415 01:14:56,440 --> 01:14:57,520 PHASE AND LOOKING AT THE 1416 01:14:57,520 --> 01:15:00,720 LONG-TERM FOLLOW-UP WE HAVE 1417 01:15:00,720 --> 01:15:03,800 EXTENDED THE FOLLOW-UP TO FIVE 1418 01:15:03,800 --> 01:15:06,760 YEARS AND ONCE WE GET TO THAT 1419 01:15:06,760 --> 01:15:13,720 POINT HOPEFULLY EVEN LONGER 1420 01:15:13,720 --> 01:15:16,240 AND THEN WITH DBS THEY PARTNER 1421 01:15:16,240 --> 01:15:22,360 WITH THEM AND ALSO 1422 01:15:22,360 --> 01:15:28,440 INSTITUTIONAL SUPPORT WITH THE 1423 01:15:28,440 --> 01:15:31,840 ADMINISTRATION FOR THE 1424 01:15:31,840 --> 01:15:36,960 COVERAGE AFTER THE TRIAL IS 1425 01:15:36,960 --> 01:15:41,520 COMPLETED AND THEN ALWAYS 1426 01:15:41,520 --> 01:15:43,320 HAVING INCLUSION OF OTHER 1427 01:15:43,320 --> 01:15:46,320 INVESTIGATORS WHO HAVE TRADING 1428 01:15:46,320 --> 01:15:51,440 AND EXPERTISE AND THAT IF IT 1429 01:15:51,440 --> 01:15:52,040 IS NO LONGER AVAILABLE WE HAVE 1430 01:15:52,040 --> 01:15:59,480 CONSIDER THESE FACTORS WITH 1431 01:15:59,480 --> 01:16:03,720 THAT PROTOCOL THAT WE HAD OF 1432 01:16:03,720 --> 01:16:07,440 OUTPATIENT MONITORING THAT WE 1433 01:16:07,440 --> 01:16:15,040 EXTEND THAT AND THEN TO LOOK 1434 01:16:15,040 --> 01:16:17,360 INTO OTHER SUPPLEMENTARY 1435 01:16:17,360 --> 01:16:23,200 SUPPORT TO COVER THOSE COSTS 1436 01:16:23,200 --> 01:16:24,760 AND OTHER FINANCIAL 1437 01:16:24,760 --> 01:16:29,240 CONSIDERATIONS AND THEN 1438 01:16:29,240 --> 01:16:30,600 LOOKING INTO SECONDARY AND 1439 01:16:30,600 --> 01:16:33,520 EXPLORATORY AND FROM THE ONSET 1440 01:16:33,520 --> 01:16:36,840 AND AS A TRIAL PROGRESSES 1441 01:16:36,840 --> 01:16:39,440 BASED OFF ON THE PATIENTS 1442 01:16:39,440 --> 01:16:44,440 RESPONSES THAT IS A PLANET - - 1443 01:16:44,440 --> 01:16:46,440 PRELIMINARY ANALYSIS TO SEE IF 1444 01:16:46,440 --> 01:16:48,880 THERE WAS SUPPLEMENTARY 1445 01:16:48,880 --> 01:16:54,080 FUNDING AND TO COVER THOSE 1446 01:16:54,080 --> 01:16:56,960 HARDWARE COST WITH THE GOAL OF 1447 01:16:56,960 --> 01:16:59,640 MOVING TOWARDS FDA APPROVAL IN 1448 01:16:59,640 --> 01:17:07,000 THE MEANTIME. 1449 01:17:07,000 --> 01:17:10,000 SO SPECIFIC TO US WE HAVE A 1450 01:17:10,000 --> 01:17:14,200 PROPOSAL FROM 2018 THE 1451 01:17:14,200 --> 01:17:18,200 NEUROSTIMULATOR FROM THE 1452 01:17:18,200 --> 01:17:20,680 ACTIVA PC THERE WAS A NEW 1453 01:17:20,680 --> 01:17:30,000 DEVICE AND THAT CAPABILITY OF 1454 01:17:30,000 --> 01:17:30,600 THOSE POTENTIALS THAT GAVE US 1455 01:17:30,600 --> 01:17:31,240 ANOTHER DATA POINT THAT DIDN'T 1456 01:17:31,240 --> 01:17:31,960 INCLUDE THE ORIGINAL PROPOSAL 1457 01:17:31,960 --> 01:17:35,680 TO GIVE US THE OPPORTUNITY 1458 01:17:35,680 --> 01:17:38,200 AFTER HE SUBMITTED THE 1459 01:17:38,200 --> 01:17:40,120 AMENDMENT WITH THE FDA 1460 01:17:40,120 --> 01:17:43,840 REQUESTING THAT DEVICE AND NOW 1461 01:17:43,840 --> 01:17:46,880 WE COULD GET PRELIMINARY DATA 1462 01:17:46,880 --> 01:17:48,440 TO POTENTIALLY WRITE 1463 01:17:48,440 --> 01:17:51,880 SUPPLEMENTARY GRANTS AND 1464 01:17:51,880 --> 01:17:54,560 PROPOSALS TO USE THE SAID 1465 01:17:54,560 --> 01:17:57,000 ADDITIONAL DATA CAPTURING 1466 01:17:57,000 --> 01:17:59,320 MECHANISM AND CONTINUOUS 1467 01:17:59,320 --> 01:18:01,640 LONGER-TERM CARE PAST THE FIVE 1468 01:18:01,640 --> 01:18:02,640 YEARS. 1469 01:18:02,640 --> 01:18:06,600 SO DEFINITELY IT'S ONE WAY TO 1470 01:18:06,600 --> 01:18:10,000 LOOK AT SUPPLEMENTARY FUNDING 1471 01:18:10,000 --> 01:18:14,440 TO CARRY OVER FOR FDA APPROVAL 1472 01:18:14,440 --> 01:18:17,240 AND UNTIL THAT IS SECURED. 1473 01:18:17,240 --> 01:18:22,600 SO IN SUMMARY THE 1474 01:18:22,600 --> 01:18:23,160 INVESTIGATIVE TEAM THAT ALSO 1475 01:18:23,160 --> 01:18:27,080 IN COLLABORATION WITH OTHERS 1476 01:18:27,080 --> 01:18:32,800 THAT SHOULD BE CONSIDERED VERY 1477 01:18:32,800 --> 01:18:33,360 EARLY ON YOU DON'T WANT TO 1478 01:18:33,360 --> 01:18:35,400 WAIT UNTIL THE END OF THE 1479 01:18:35,400 --> 01:18:37,880 STUDY WHAT WE DO WITH 1480 01:18:37,880 --> 01:18:42,320 POSTTRIAL CARE AND BEFORE THAT 1481 01:18:42,320 --> 01:18:42,840 IS SUBMITTED VERY EARLY ON 1482 01:18:42,840 --> 01:18:46,120 ALWAYS HAVE TO KEEP THE 1483 01:18:46,120 --> 01:18:50,200 PARTICIPANTS AT THE FOREFRONT. 1484 01:18:50,200 --> 01:18:51,640 THAT TRANSPARENCY WITH THE 1485 01:18:51,640 --> 01:18:55,520 PARTICIPANTS WHEN DISCUSSING 1486 01:18:55,520 --> 01:18:59,280 POST TRIAL CARE WHAT IS 1487 01:18:59,280 --> 01:19:01,600 EXPECTED OF THEM AND OF THE 1488 01:19:01,600 --> 01:19:04,600 TEAM AND WHAT METHODS ARE PUT 1489 01:19:04,600 --> 01:19:07,160 INTO PLACE TO MAKE SURE THEIR 1490 01:19:07,160 --> 01:19:10,440 CARE WILL BE MET WITH THE POST 1491 01:19:10,440 --> 01:19:14,960 STUDY COMPLETION AND THEN ALSO 1492 01:19:14,960 --> 01:19:15,440 LOOKING INTO THOSE OTHER 1493 01:19:15,440 --> 01:19:20,320 FUNDING MECHANISMS TO MAKE 1494 01:19:20,320 --> 01:19:20,920 SURE THOSE POSTTRIAL NEEDS ARE 1495 01:19:20,920 --> 01:19:21,360 MET AND CONTINUOUSLY 1496 01:19:21,360 --> 01:19:27,880 REVISITING THAT AND THEN ALSO 1497 01:19:27,880 --> 01:19:33,440 LOOKING AT THE OTHER OPTIONS 1498 01:19:33,440 --> 01:19:36,000 AND THEN I'LL ANSWER ANY 1499 01:19:36,000 --> 01:19:45,360 QUESTIONS. 1500 01:19:45,360 --> 01:19:45,760 >> WITH THE QUESTION 1501 01:19:45,760 --> 01:19:49,000 SPECIFICALLY FOR THIS 1502 01:19:49,000 --> 01:19:51,560 PRESENTATION ANY QUESTION 1503 01:19:51,560 --> 01:19:53,880 SPECIFICALLY FOR DOCTOR 1504 01:19:53,880 --> 01:20:01,360 MAHONEY? 1505 01:20:01,360 --> 01:20:03,960 >> THIS IS A FASCINATING 1506 01:20:03,960 --> 01:20:05,160 STUDY. 1507 01:20:05,160 --> 01:20:10,160 I SEE SUCH SIMILARITIES WITH 1508 01:20:10,160 --> 01:20:11,120 HER TALK AND THINKING ABOUT 1509 01:20:11,120 --> 01:20:15,960 THE AGE OF WHAT IS LIKELY IN 1510 01:20:15,960 --> 01:20:16,720 THE PREDICTION STUDY AND I AM 1511 01:20:16,720 --> 01:20:18,640 JUST WONDERING IT SEEMS 1512 01:20:18,640 --> 01:20:23,680 FANTASTIC IN SOME WAYS HE WILL 1513 01:20:23,680 --> 01:20:33,960 BE THAT I JUST WONDER THOSE 1514 01:20:33,960 --> 01:20:34,560 PEOPLE THAT WILL HAVE 30 PLUS 1515 01:20:34,560 --> 01:20:35,120 YEARS WITH A DEVICE IF IT IS 1516 01:20:35,120 --> 01:20:36,760 WORKING FOR THEM. 1517 01:20:36,760 --> 01:20:44,640 IS THE UNIVERSITY OFFERING 1518 01:20:44,640 --> 01:20:47,080 HAVE THEY TALKED ABOUT A TIME 1519 01:20:47,080 --> 01:20:47,280 LIMIT? 1520 01:20:47,280 --> 01:20:49,400 HOW HAS THAT BEEN HANDLED 1521 01:20:49,400 --> 01:20:49,600 QUICK. 1522 01:20:49,600 --> 01:20:53,160 >> ABSOLUTELY NOT AND FROM THE 1523 01:20:53,160 --> 01:20:58,000 BEGINNING THIS IS THE ANALYSIS 1524 01:20:58,000 --> 01:21:02,680 WITH A VERY HIGH RISK OF DEAF 1525 01:21:02,680 --> 01:21:05,240 AND THEY HAVE TO HAVE MULTIPLE 1526 01:21:05,240 --> 01:21:08,080 OVERDOSES SO THAT THE HIGH 1527 01:21:08,080 --> 01:21:08,640 RISK OF DEAF BUT I BROUGHT 1528 01:21:08,640 --> 01:21:10,880 THAT UP IN THE BEGINNING SO 1529 01:21:10,880 --> 01:21:13,400 WITH 30 YEARS OF AGE THERE IS 1530 01:21:13,400 --> 01:21:20,760 NO REASON BUT THEN EVERY 1531 01:21:20,760 --> 01:21:25,960 COUPLE OF YEARS WITH THOSE 1532 01:21:25,960 --> 01:21:26,520 BATTERY REPLACEMENTS AND IN 1533 01:21:26,520 --> 01:21:29,720 THE ONGOING SUPPORT SO THAT 1534 01:21:29,720 --> 01:21:35,760 FIVE YEARS AND THAT ATTENTION 1535 01:21:35,760 --> 01:21:41,880 IS FURTHER ON FOR THE FIRST 1536 01:21:41,880 --> 01:21:49,720 TEN OR 15 YEARS SO WE ARE VERY 1537 01:21:49,720 --> 01:21:50,200 FORTUNATE TO HAVE THEIR 1538 01:21:50,200 --> 01:21:50,760 SUPPORT AND WHAT'S GOING ON 1539 01:21:50,760 --> 01:21:54,720 RIGHT NOW ESPECIALLY IN WEST 1540 01:21:54,720 --> 01:21:58,120 VIRGINIA IN TERMS OF THE 1541 01:21:58,120 --> 01:22:00,800 ADDICTION CRISIS WE DO HAVE 1542 01:22:00,800 --> 01:22:07,080 THAT SUPPORT HERE BUT IT IS A 1543 01:22:07,080 --> 01:22:11,840 GREAT POINT WITH THE 1544 01:22:11,840 --> 01:22:15,200 RECHARGEABLE ONES BUT WITH 1545 01:22:15,200 --> 01:22:19,800 THIS INITIAL STUDY GIVEN ALL 1546 01:22:19,800 --> 01:22:23,680 THE CHAOS FROM THE SUBSTANCE 1547 01:22:23,680 --> 01:22:26,800 USE DISORDER RELYING ON HOW TO 1548 01:22:26,800 --> 01:22:31,760 RECHARGE IT AND ALL OF THAT 1549 01:22:31,760 --> 01:22:32,320 BUT THEN SOMETHING ME WILL 1550 01:22:32,320 --> 01:22:33,360 EXPLORE IN THE FUTURE 1551 01:22:33,360 --> 01:22:42,160 DEFINITELY BUT YOU ARE RIGHT 1552 01:22:42,160 --> 01:22:42,760 THAT'S WHY IT'S GREAT TO HAVE 1553 01:22:42,760 --> 01:22:43,320 WORKSHOPS LIKE THIS BECAUSE 1554 01:22:43,320 --> 01:22:43,920 THIS NEEDS TO BE DISCUSSED AND 1555 01:22:43,920 --> 01:22:44,840 CONSIDERED EARLY ON IN THE 1556 01:22:44,840 --> 01:22:50,200 PROCESS BECAUSE WE ARE 1557 01:22:50,200 --> 01:22:50,800 RECRUITING INDIVIDUALS WITH A 1558 01:22:50,800 --> 01:22:53,800 HIGH RISK OF DEAF BUT 1559 01:22:53,800 --> 01:22:54,400 POTENTIALLY WE ARE GIVING THEM 1560 01:22:54,400 --> 01:22:58,640 THEIR LIVES BACK. 1561 01:22:58,640 --> 01:22:59,160 THAT'S THE CASE WE NEED TO 1562 01:22:59,160 --> 01:23:04,280 ENSURE WE TAKE CARE OF THEM 1563 01:23:04,280 --> 01:23:13,640 CONTINUOUSLY. 1564 01:23:13,640 --> 01:23:21,720 >> SO WHAT MISS ALICE OR 1565 01:23:21,720 --> 01:23:26,960 MS. FRENCH HAD AND THEN WE HAD 1566 01:23:26,960 --> 01:23:27,520 SOME EXPERIENCE WITH PEOPLE 1567 01:23:27,520 --> 01:23:34,320 WHO HAD DEVICES OVER DECADES 1568 01:23:34,320 --> 01:23:34,840 SO WE ARE CURIOUS TO HEAR 1569 01:23:34,840 --> 01:23:42,960 ABOUT THAT EXPERIENCE AND THEN 1570 01:23:42,960 --> 01:23:43,520 TO INVITE THE OTHER PANELIST 1571 01:23:43,520 --> 01:23:45,680 TO TURN ON THEIR CAMERAS I AM 1572 01:23:45,680 --> 01:23:49,360 A NEUROLOGIST AND THE DIRECTOR 1573 01:23:49,360 --> 01:23:53,440 OF BIOETHICS. 1574 01:23:53,440 --> 01:24:03,920 >> I AM A SPECIALIST WORKING 1575 01:24:05,560 --> 01:24:07,240 WITH THE BRAIN NEWG. 1576 01:24:07,240 --> 01:24:12,640 >> SAID TO ANSWER THE QUESTION 1577 01:24:12,640 --> 01:24:13,240 WE WOULD LIKE TO HEAR A LITTLE 1578 01:24:13,240 --> 01:24:15,640 MORE ABOUT HOW FAR INTO THE 1579 01:24:15,640 --> 01:24:19,800 FUTURE THEWERE THINKING ATTHE TD 1580 01:24:19,800 --> 01:24:23,240 WAS 18 MONTHS ANOTHER MAY HAVE 1581 01:24:23,240 --> 01:24:25,560 BEEN LESS CLEAR BUT WHAT KIND 1582 01:24:25,560 --> 01:24:32,200 OF CONVERSATIONS DID WE HAVE 1583 01:24:32,200 --> 01:24:33,240 WHAT CONVERSATIONS SHOULD WE 1584 01:24:33,240 --> 01:24:38,520 BE HAVING WHERE THE HORIZON IS 1585 01:24:38,520 --> 01:24:41,840 VERY MURKY? 1586 01:24:41,840 --> 01:24:42,920 >> BEFORE WE BEGIN TO ANSWER 1587 01:24:42,920 --> 01:24:48,400 THE QUESTION I WANT TO WELCOME 1588 01:24:48,400 --> 01:24:51,160 TYLER WHO IS A PATIENT 1589 01:24:51,160 --> 01:24:52,720 PARTICIPANT HE CAN JOIN 1590 01:24:52,720 --> 01:24:57,520 TODAY'S WE WELCOME YOUR INPUT 1591 01:24:57,520 --> 01:24:58,040 AS WELL AS PERSPECTIVES AS 1592 01:24:58,040 --> 01:25:04,160 PART OF THE PANEL. 1593 01:25:04,160 --> 01:25:11,160 >> WITH MY ORIGINAL TRIAL I 1594 01:25:11,160 --> 01:25:11,760 WENT TO THE ATLANTA AREA I HAD 1595 01:25:11,760 --> 01:25:12,360 TO AGREE TO BE FOLLOWED UP FOR 1596 01:25:12,360 --> 01:25:15,080 AT LEAST ONE YEAR AND AFTER 1597 01:25:15,080 --> 01:25:16,560 THAT IT NATIONALLY 1598 01:25:16,560 --> 01:25:21,320 TRANSITIONED AND THE 1599 01:25:21,320 --> 01:25:21,880 DISCUSSIONS ORIGINALLY WERE 1600 01:25:21,880 --> 01:25:25,840 ALONG THE LINES OF TEN YEARS 1601 01:25:25,840 --> 01:25:28,760 OR FDA APPROVAL WHICHEVER 1602 01:25:28,760 --> 01:25:29,040 COMES FIRST. 1603 01:25:29,040 --> 01:25:32,240 THE TEN YEARS CAME FIRST I 1604 01:25:32,240 --> 01:25:34,680 UNDERSTAND THAT IS A FINITE 1605 01:25:34,680 --> 01:25:38,720 NUMBER BECAUSE A PARTICIPANT 1606 01:25:38,720 --> 01:25:44,520 IN THE EXPERIMENTAL TRIAL FOR 1607 01:25:44,520 --> 01:25:45,520 THE REST OF MY LIFE WITH NO 1608 01:25:45,520 --> 01:25:46,920 DEFINED TERMS. 1609 01:25:46,920 --> 01:25:49,120 IT'S MY UNDERSTANDING IS 1610 01:25:49,120 --> 01:25:52,760 SOMETHING CHANGES I NEED IT 1611 01:25:52,760 --> 01:25:53,680 REPLACED OR THERE'S SOMETHING 1612 01:25:53,680 --> 01:25:56,600 WITH THE IMPLANT I NEED TO BE 1613 01:25:56,600 --> 01:26:00,440 WE CONSENTED. 1614 01:26:00,440 --> 01:26:01,520 BUT THE TRANSITION FROM YOUR 1615 01:26:01,520 --> 01:26:04,920 NUMBER ONE THROUGH TWO OR 1616 01:26:04,920 --> 01:26:07,360 THREE OR FOUR WAS NOT A BIG 1617 01:26:07,360 --> 01:26:09,480 CHANGE. 1618 01:26:09,480 --> 01:26:11,000 MY TRIAL TEAM HAS BEEN VERY 1619 01:26:11,000 --> 01:26:13,400 COMMUNICATIVE FOR AS LONG AS 1620 01:26:13,400 --> 01:26:14,920 I'M WILLING TO DO FOLLOW-UPS 1621 01:26:14,920 --> 01:26:19,680 , THEY WOULD LIKE THAT. 1622 01:26:19,680 --> 01:26:20,280 AND I'M TRYING TO HELP IN ANY 1623 01:26:20,280 --> 01:26:24,560 WAY THAT I CAN. 1624 01:26:24,560 --> 01:26:27,480 BUT THERE WERE ALLIED OF 1625 01:26:27,480 --> 01:26:28,200 QUESTIONS ABOUT WHAT HAPPENS 1626 01:26:28,200 --> 01:26:31,920 AFTER TEN YEARS? 1627 01:26:31,920 --> 01:26:32,440 AND IT IS FRUSTRATING THAT 1628 01:26:32,440 --> 01:26:34,160 NOBODY KNOWS ANYTHING MORE 1629 01:26:34,160 --> 01:26:42,160 THAN I DO NOBODY KNOWS WERE 1630 01:26:42,160 --> 01:26:42,720 THIS WILL BE TEN OR 20 OR 30 1631 01:26:42,720 --> 01:26:46,320 YEARS DOWN THE ROAD AND WHAT 1632 01:26:46,320 --> 01:26:51,760 MY OPTIONS WILL BE OR WHERE I 1633 01:26:51,760 --> 01:26:52,600 MIGHT HAVE SURGERY IF I NEED 1634 01:26:52,600 --> 01:26:54,800 ANOTHER SURGERY. 1635 01:26:54,800 --> 01:26:58,560 THOSE ARE KNOWN UNKNOWNS AND 1636 01:26:58,560 --> 01:27:03,040 THEY DO CAUSE ANXIETY FOR 1637 01:27:03,040 --> 01:27:03,640 PARTICIPANTS BUT I DON'T KNOW 1638 01:27:03,640 --> 01:27:04,960 IF IT IS REASONABLE TO EXPECT 1639 01:27:04,960 --> 01:27:08,480 MY TRIAL TEAM TO KNOW HOW I 1640 01:27:08,480 --> 01:27:10,840 WILL BE TREATED 20 YEARS FROM 1641 01:27:10,840 --> 01:27:14,720 NOW. 1642 01:27:14,720 --> 01:27:15,840 BUT THIS PAST NOVEMBER WAS 1643 01:27:15,840 --> 01:27:20,000 MADE TEN YEARS I AM NOW 1644 01:27:20,000 --> 01:27:20,280 GRADUATED. 1645 01:27:20,280 --> 01:27:22,600 HOW TO PHRASE THAT BUT I AM 1646 01:27:22,600 --> 01:27:28,920 NOT UNDER CONSENT ANYMORE. 1647 01:27:28,920 --> 01:27:29,440 >> IT'S INTERESTING BRANDY 1648 01:27:29,440 --> 01:27:30,480 COME I HAD A SIMILAR 1649 01:27:30,480 --> 01:27:32,280 EXPERIENCE. 1650 01:27:32,280 --> 01:27:37,520 MY NOW HUSBAND WE MOVED TO 1651 01:27:37,520 --> 01:27:42,880 CLEVELAND TO PARTICIPATE SO 1652 01:27:42,880 --> 01:27:43,480 ONLY THOSE THAT ARE FLUENT IN 1653 01:27:43,480 --> 01:27:47,240 THE SUPPORT SYSTEM AROUND THEM 1654 01:27:47,240 --> 01:27:48,080 WE HAVE TO THINK OF THOSE 1655 01:27:48,080 --> 01:27:54,160 FINANCIAL BURDENS FOR 1656 01:27:54,160 --> 01:27:54,760 PARTICIPATION BECAUSE IT IS A 1657 01:27:54,760 --> 01:27:55,320 HUGE PERIOD FOR A LOT OF CAN 1658 01:27:55,320 --> 01:27:59,840 CLINICAL TRIAL PARTICIPANTS 1659 01:27:59,840 --> 01:28:00,400 AND FOR ME PERSONALLY I WAS 1660 01:28:00,400 --> 01:28:01,000 INJURED 24 YEARS AGO AND I HAD 1661 01:28:01,000 --> 01:28:02,960 NO IDEA I WOULD BE INJURED 1662 01:28:02,960 --> 01:28:11,040 THIS LONG OR THAT THE DEVICE 1663 01:28:11,040 --> 01:28:11,600 WOULD CONTINUE TO WORK THIS 1664 01:28:11,600 --> 01:28:12,200 LONG MANY INVESTIGATORS ARE 1665 01:28:12,200 --> 01:28:13,440 STILL AMAZED ONE OF MY 1666 01:28:13,440 --> 01:28:16,960 ORIGINAL IPG IS STILL TAKING 1667 01:28:16,960 --> 01:28:18,440 KNOCK ON WOOD. 1668 01:28:18,440 --> 01:28:22,360 BUT THAT ALLOWS FOR FUNCTION 1669 01:28:22,360 --> 01:28:24,720 AND THEN TO APPLY THE 1670 01:28:24,720 --> 01:28:29,040 FORESIGHT WITH THE RESEARCH 1671 01:28:29,040 --> 01:28:29,640 AND DEVELOPMENT PORTFOLIO THEY 1672 01:28:29,640 --> 01:28:31,520 TOOK A DISTINCT INTEREST TO 1673 01:28:31,520 --> 01:28:36,040 FOLLOW LONG-TERM TO UNDERSTAND 1674 01:28:36,040 --> 01:28:36,640 WHAT THEY ARE OF THOSE DEVICES 1675 01:28:36,640 --> 01:28:41,000 AND WHEN WE THINK ABOUT VERY 1676 01:28:41,000 --> 01:28:41,600 EXPERIMENTAL DEVICES LONG-TERM 1677 01:28:41,600 --> 01:28:44,920 STUDIES CAN HELP US FURTHER 1678 01:28:44,920 --> 01:28:45,880 DEVELOP THAT TECHNOLOGY AS WE 1679 01:28:45,880 --> 01:28:51,800 GO ALONG SO IT'S IN OUR BEST 1680 01:28:51,800 --> 01:28:52,320 INTEREST HOW WE PUT THESE 1681 01:28:52,320 --> 01:28:56,560 DEVICES AT WORK AND ALSO WITH 1682 01:28:56,560 --> 01:28:57,880 THE CLINICAL TRIAL 1683 01:28:57,880 --> 01:29:06,960 PARTICIPANTS. 1684 01:29:06,960 --> 01:29:07,520 >> AND THEN TO SEE IF WE WANT 1685 01:29:07,520 --> 01:29:14,520 TO WEIGH IN AS WELL? 1686 01:29:14,520 --> 01:29:18,360 >> I AM IN THE SAME STUDY AS 1687 01:29:18,360 --> 01:29:21,440 BRANDY. 1688 01:29:21,440 --> 01:29:22,040 I'M JUST TRYING TO THINK WHEN 1689 01:29:22,040 --> 01:29:27,280 I FIRST HAD THE SURGERY IF IT 1690 01:29:27,280 --> 01:29:29,760 WAS THAT BUT THERE WERE NOT 1691 01:29:29,760 --> 01:29:32,480 MANY OPTIONS. 1692 01:29:32,480 --> 01:29:34,040 WASN'T THINKING ABOUT THE 1693 01:29:34,040 --> 01:29:37,280 FUTURE TOO MUCH AND NOW I'M 1694 01:29:37,280 --> 01:29:43,120 THREE YEARS INTO THIS AND NOW 1695 01:29:43,120 --> 01:29:48,880 WITH YOUR NUMBER THREE IN MY 1696 01:29:48,880 --> 01:29:53,080 PART OF THE TRIAL WAS OVER 1697 01:29:53,080 --> 01:29:59,800 MAYBE ONLY FOR SIX MONTHS THE 1698 01:29:59,800 --> 01:30:02,280 DOCTOR THAT I COMMUNICATED 1699 01:30:02,280 --> 01:30:07,960 WITH IT WAS THE ACTUAL NUMBER 1700 01:30:07,960 --> 01:30:08,520 BUT I WASN'T THINKING ABOUT 1701 01:30:08,520 --> 01:30:18,080 ANY OF THESE THINGS BUT IN MY 1702 01:30:18,080 --> 01:30:18,560 BATTERY WAS RECHARGEABLE 1703 01:30:18,560 --> 01:30:20,040 MUSCLES TO LAST 15 YEARS BUT 1704 01:30:20,040 --> 01:30:23,960 AGAIN BEFORE BRANDY SHARED AND 1705 01:30:23,960 --> 01:30:26,880 NEVER CROSSED MY MIND THAT IT 1706 01:30:26,880 --> 01:30:28,680 COULD MALFUNCTION OR IF IT DID 1707 01:30:28,680 --> 01:30:33,680 I HAVE TO LIVE DAY BY DAY OR 1708 01:30:33,680 --> 01:30:36,160 MY EXAM ZAIDI WILL GET OUT OF 1709 01:30:36,160 --> 01:30:38,680 CONTROL SO I CROSS THOSE 1710 01:30:38,680 --> 01:30:43,480 BRIDGES WHEN I COME TO IT AND 1711 01:30:43,480 --> 01:30:45,320 IT WOULD BE GREAT TO HAVE 1712 01:30:45,320 --> 01:30:47,840 THOSE THINGS THAT RANDY 1713 01:30:47,840 --> 01:30:56,640 MENTIONED AND THAT WOULD BE 1714 01:30:56,640 --> 01:30:59,200 INCREDIBLE BECAUSE THE PAST 1715 01:30:59,200 --> 01:31:05,640 YEAR AND THEN I DO HAVE 1716 01:31:05,640 --> 01:31:11,200 INSURANCE AT THIS POINT AND IT 1717 01:31:11,200 --> 01:31:11,640 DOES CARE FOR THOSE 1718 01:31:11,640 --> 01:31:13,920 MAINTENANCE PROCEDURES BUT WHO 1719 01:31:13,920 --> 01:31:16,360 KNOWS WHAT THE FUTURE WILL 1720 01:31:16,360 --> 01:31:19,320 HOLD THAT NOBODY KNOWS WHAT 1721 01:31:19,320 --> 01:31:29,840 WILL HAPPEN TOMORROW WITH B OR 1722 01:31:31,280 --> 01:31:33,640 C OR D BECAUSE OF THIS DOESN'T 1723 01:31:33,640 --> 01:31:34,840 WORK I DON'T HAVE A LIFE. 1724 01:31:34,840 --> 01:31:38,440 I'M 31 YEARS OLD AND I HAVE 1725 01:31:38,440 --> 01:31:40,040 ALREADY LAST TEN YEARS TO A 1726 01:31:40,040 --> 01:31:44,960 TREATMENT RESISTANT DEPRESSION 1727 01:31:44,960 --> 01:31:45,480 AND I WOULD LIKE TO START 1728 01:31:45,480 --> 01:31:47,600 PICKING UP THE PACE A LITTLE 1729 01:31:47,600 --> 01:31:49,600 BIT AND AGAIN HAVING JENNIFER 1730 01:31:49,600 --> 01:31:56,280 HERE AS WELL 24 YEARS OF THIS 1731 01:31:56,280 --> 01:31:58,720 EXPERIENCES EYE-OPENING AS 1732 01:31:58,720 --> 01:32:02,000 WELL SO I AGREE WITH ALL THE 1733 01:32:02,000 --> 01:32:06,400 POINTS THAT THEY MADE AS FAR 1734 01:32:06,400 --> 01:32:11,200 AS PLAN OF ATTACK AND THE 1735 01:32:11,200 --> 01:32:21,720 GUARANTEED COVERAGE IS HELPFUL 1736 01:32:22,280 --> 01:32:22,760 AND WE ARE NOT MADE OF MONEY 1737 01:32:22,760 --> 01:32:23,320 PER SE BUT WE HAVE BEEN ABLE 1738 01:32:23,320 --> 01:32:33,800 TO FIND WAYS TO PURSUE THIS 1739 01:32:34,400 --> 01:32:34,960 EDGES LIFE OR DEAF OF FIVE TO 1740 01:32:34,960 --> 01:32:35,560 ACCUMULATE DEBT TO STAY ALIVE 1741 01:32:35,560 --> 01:32:36,080 THAN IT'S WORTH IT FOR ME 1742 01:32:36,080 --> 01:32:36,600 BECAUSE THEN I HAVE THE 1743 01:32:36,600 --> 01:32:37,120 OPPORTUNITY TO PAY OFF THE 1744 01:32:37,120 --> 01:32:39,040 DEBT. 1745 01:32:39,040 --> 01:32:39,600 BUT IT WOULD BE GREAT TO GET 1746 01:32:39,600 --> 01:32:40,200 HELP WITH AS WE HAVE TO KEEP 1747 01:32:40,200 --> 01:32:42,320 BUILDING THAT UP. 1748 01:32:42,320 --> 01:32:52,480 THANK YOU. 1749 01:32:55,480 --> 01:32:55,920 >> SO FURTHER ALONG IN THE 1750 01:32:55,920 --> 01:32:58,000 COMMERCIALIZATION OF THE 1751 01:32:58,000 --> 01:33:01,720 DEVICE SOME OF THOSE MAY 1752 01:33:01,720 --> 01:33:04,360 REMEMBER MORE RECENTLY THE 1753 01:33:04,360 --> 01:33:06,080 SECOND SITE AND WITH THAT 1754 01:33:06,080 --> 01:33:06,640 DEVELOPMENT OF THOSE DEVICES 1755 01:33:06,640 --> 01:33:10,560 VERY EARLY ON TO BRING 1756 01:33:10,560 --> 01:33:19,840 PROFOUND IMPACT AND TO THINK 1757 01:33:19,840 --> 01:33:20,440 WHAT HAPPENS WHEN A COMPANY 1758 01:33:20,440 --> 01:33:21,000 GOES OUT OF BUSINESS ARE NO 1759 01:33:21,000 --> 01:33:26,560 LONGER AVAILABLE AND HOW 1760 01:33:26,560 --> 01:33:27,160 SOMEONE TRANSITIONS AWAY FROM 1761 01:33:27,160 --> 01:33:29,080 THAT AND WHAT THAT MIGHT LOOK 1762 01:33:29,080 --> 01:33:32,440 LIKE THERE WAS A REALLY GOOD 1763 01:33:32,440 --> 01:33:33,600 COMMENTS IN THE CHAT IF 1764 01:33:33,600 --> 01:33:37,600 SOMEONE IS GOING TO RECEIVE 1765 01:33:37,600 --> 01:33:43,000 COVERAGE THEY WOULD BE A 1766 01:33:43,000 --> 01:33:43,600 LONG-TERM TRIAL PARTICIPANTS 1767 01:33:43,600 --> 01:33:45,000 SO IT IS A TWO WAY STREET 1768 01:33:45,000 --> 01:33:49,760 THOSE WHO ARE A PARTNERSHIP OR 1769 01:33:49,760 --> 01:33:50,360 A COLLABORATION WE ARE TRY TO 1770 01:33:50,360 --> 01:33:58,120 GET TO THE POINT AND TO 1771 01:33:58,120 --> 01:34:02,360 ENCOUNTER HEALTHWISE. 1772 01:34:02,360 --> 01:34:04,880 >> THESE VOICES ARE REALLY 1773 01:34:04,880 --> 01:34:06,480 POWERFUL AND HEARING YOU ALL 1774 01:34:06,480 --> 01:34:12,600 ARE ALL VERY GRATEFUL AND WITH 1775 01:34:12,600 --> 01:34:13,200 THE TOPICS WITH A Q&A WITH THE 1776 01:34:13,200 --> 01:34:23,720 PANEL DISCUSSION AS WELL SO TO 1777 01:34:24,200 --> 01:34:24,720 HAVE THE OPPORTUNITY TO INJECT 1778 01:34:24,720 --> 01:34:25,200 SOME THOUGHTS INTO THE 1779 01:34:25,200 --> 01:34:25,480 DISCUSSION. 1780 01:34:25,480 --> 01:34:26,080 >> FIRST OF ALL THANK YOU THE 1781 01:34:26,080 --> 01:34:26,680 PANEL WAS WONDERFUL AND FOOD 1782 01:34:26,680 --> 01:34:30,640 FOR THOUGHT. 1783 01:34:30,640 --> 01:34:35,640 WITH THE REAFFIRMED TO THE 1784 01:34:35,640 --> 01:34:42,680 NEEDS AND THAT'S WHAT I 1785 01:34:42,680 --> 01:34:43,200 UNDERSTAND ARE INCREDIBLY 1786 01:34:43,200 --> 01:34:43,800 IMPORTANT BUT I HAVE HEARD TO 1787 01:34:43,800 --> 01:34:47,200 THE HAVE NOT HEARD BEFORE SO 1788 01:34:47,200 --> 01:34:53,240 ONE WAS THAT JENNIFER 1789 01:34:53,240 --> 01:34:55,600 MENTIONED REGISTRY OR PUBLIC 1790 01:34:55,600 --> 01:35:03,360 DATA AND I WANT TO UNDERSTAND 1791 01:35:03,360 --> 01:35:03,880 HOW THAT IS MEETING ONE OF 1792 01:35:03,880 --> 01:35:04,200 YOUR NEEDS? 1793 01:35:04,200 --> 01:35:04,720 ONE OF THE REASONS THAT IS 1794 01:35:04,720 --> 01:35:07,840 HELPFUL AND SIMILARLY I THINK 1795 01:35:07,840 --> 01:35:09,240 IT IS BRANDY THAT MENTIONED 1796 01:35:09,240 --> 01:35:14,600 INCENTIVES TO MAINTAIN 1797 01:35:14,600 --> 01:35:18,000 COMPATIBILITY. 1798 01:35:18,000 --> 01:35:19,080 HOW DOES THAT HELP IN TERMS OF 1799 01:35:19,080 --> 01:35:22,080 LONG-TERM NEEDS? 1800 01:35:22,080 --> 01:35:23,200 THANK YOU. 1801 01:35:23,200 --> 01:35:25,880 >> YES. 1802 01:35:25,880 --> 01:35:31,320 I'M HAPPY TO SPEAK TO MY POINT 1803 01:35:31,320 --> 01:35:33,800 FOR ME THE REASON I MENTIONED 1804 01:35:33,800 --> 01:35:38,400 REGISTRY IS THAT I AM 1805 01:35:38,400 --> 01:35:40,800 CONTEMPLATING IF I DECIDE TO 1806 01:35:40,800 --> 01:35:44,920 RETIRE TO PANAMA AND MY TRIAL 1807 01:35:44,920 --> 01:35:53,040 TEAM IS ALSO RETIRED IS HAVING 1808 01:35:53,040 --> 01:35:59,480 A CENTRAL DATABASE THAT SAYS 1809 01:35:59,480 --> 01:36:04,160 THIS PERSON WAS LEGITIMATELY 1810 01:36:04,160 --> 01:36:05,840 INVOLV INVOLVED. 1811 01:36:05,840 --> 01:36:09,320 HERE IS THERE SETTINGS AND 1812 01:36:09,320 --> 01:36:12,280 HERE IS WHERE THEY CAN GET A 1813 01:36:12,280 --> 01:36:15,120 DEVICE. 1814 01:36:15,120 --> 01:36:15,720 AND THAT SORT OF INFORMATION 1815 01:36:15,720 --> 01:36:23,000 THAT CAN BE, LIKE MY MEDICAL 1816 01:36:23,000 --> 01:36:24,680 RECORD DOESN'T ACTUALLY 1817 01:36:24,680 --> 01:36:27,440 CONTAIN THE TRIAL. 1818 01:36:27,440 --> 01:36:30,800 IT CONTAINS MY SURGERIES BUT 1819 01:36:30,800 --> 01:36:33,320 IT DOESN'T HAVE MY TRIAL 1820 01:36:33,320 --> 01:36:35,840 INFORMATION. 1821 01:36:35,840 --> 01:36:36,280 SO I WORRY ABOUT BEING 1822 01:36:36,280 --> 01:36:44,040 SOMEWHERE ELSE AND BEING ABLE 1823 01:36:44,040 --> 01:36:44,640 TO PROVIDE DOCUMENTATION WHAT 1824 01:36:44,640 --> 01:36:45,200 THE SETTINGS ARE SUPPOSED TO 1825 01:36:45,200 --> 01:36:46,480 BE WITH THAT INFORMATION 1826 01:36:46,480 --> 01:36:48,720 BECAUSE I CANNOT CHANGE MY 1827 01:36:48,720 --> 01:36:49,000 SETTINGS. 1828 01:36:49,000 --> 01:36:55,240 TO HAVE ANY IMPACT SO IN THE 1829 01:36:55,240 --> 01:36:58,560 ABSENCE IF ATLANTA IS NOT 1830 01:36:58,560 --> 01:37:01,120 ACCESSIBLE FOR THERE TO BE A 1831 01:37:01,120 --> 01:37:08,720 WAY TO GET THAT INFORMATION 1832 01:37:08,720 --> 01:37:12,400 AND WITH BUT I CONSENTED TO I 1833 01:37:12,400 --> 01:37:13,000 KNOW I CAN ASK FOR THEM BUT AT 1834 01:37:13,000 --> 01:37:18,760 THE SAME TIME IT'S BEEN TEN 1835 01:37:18,760 --> 01:37:24,120 YEARS BUT FOR INCENTIVES, IT 1836 01:37:24,120 --> 01:37:31,400 IS TWOFOLD FOR THOSE THAT ARE 1837 01:37:31,400 --> 01:37:31,960 UNDERREPRESENTED TO GET THE 1838 01:37:31,960 --> 01:37:33,880 OPPORTUNITY TO PARTICIPATE IN 1839 01:37:33,880 --> 01:37:35,600 THESE TRIALS. 1840 01:37:35,600 --> 01:37:40,640 BECAUSE WE NEED THAT. 1841 01:37:40,640 --> 01:37:42,920 BUT WHEN RATINGS TAKE ALL 1842 01:37:42,920 --> 01:37:46,560 DAY, IF YOU ARE CAPABLE OF 1843 01:37:46,560 --> 01:37:47,760 WORKING THEN YOU NEED MORE 1844 01:37:47,760 --> 01:37:52,600 THAN JUST YOUR PARKING 1845 01:37:52,600 --> 01:37:54,040 VALIDATED IT IS SIMILAR TO 1846 01:37:54,040 --> 01:37:55,200 JURY DUTY IF NOBODY DOES IT 1847 01:37:55,200 --> 01:38:01,120 FOR THE MONEY AND THERE NEEDS 1848 01:38:01,120 --> 01:38:03,080 TO BE A WAY TO MAKE IT 1849 01:38:03,080 --> 01:38:04,120 POSSIBLE FOR PEOPLE WITH 1850 01:38:04,120 --> 01:38:07,600 DIFFERENT MEANS AND 1851 01:38:07,600 --> 01:38:09,200 UNDERREPRESENTED TO HAVE 1852 01:38:09,200 --> 01:38:13,800 ASSISTANCE WITH RELOCATION 1853 01:38:13,800 --> 01:38:17,080 WERE TAKING TIME OFF OF WORK 1854 01:38:17,080 --> 01:38:20,440 AND SEPARATE FROM THAT I WOULD 1855 01:38:20,440 --> 01:38:22,960 LOVE FOR MY DEVICE 1856 01:38:22,960 --> 01:38:27,800 MANUFACTURER TO CREATE AND 1857 01:38:27,800 --> 01:38:30,320 HARNESS THAT WHICH ALLOWS MY 1858 01:38:30,320 --> 01:38:31,760 ELECTRODES TO BE SWAPPED OUT 1859 01:38:31,760 --> 01:38:37,000 WITH ANY BATTERY ON THE MARKET 1860 01:38:37,000 --> 01:38:37,600 BUT WHY WOULD THEY DO THAT IF 1861 01:38:37,600 --> 01:38:41,960 THEY DON'T HAVE AN INCENTIVE 1862 01:38:41,960 --> 01:38:42,560 TO STANDARDIZE THE THINGS THEY 1863 01:38:42,560 --> 01:38:44,480 ARE IMPLANTING? 1864 01:38:44,480 --> 01:38:48,760 AND TO MAKE THEM CROSS 1865 01:38:48,760 --> 01:38:51,600 COMPATIBLE. 1866 01:38:51,600 --> 01:38:54,120 I WANT THEM TO HAVE A REASON 1867 01:38:54,120 --> 01:39:00,920 WHY MY DEVICE CAN BE SWAPPED 1868 01:39:00,920 --> 01:39:06,320 OUT BECAUSE I MOVE SOMEWHERE 1869 01:39:06,320 --> 01:39:06,920 ELSE AND DON'T HAVE ACCESS TO 1870 01:39:06,920 --> 01:39:07,400 THIS PARTICULAR DEVICE 1871 01:39:07,400 --> 01:39:09,960 MANUFACTURER ANYMORE. 1872 01:39:09,960 --> 01:39:12,080 SO WITH WANTING INSURANCE 1873 01:39:12,080 --> 01:39:18,520 COVERAGE AND COMPATIBILITY AND 1874 01:39:18,520 --> 01:39:19,080 I UNDERSTAND THAT BUSINESSES 1875 01:39:19,080 --> 01:39:23,960 THAT ARE INVOLVED IN THIS ARE 1876 01:39:23,960 --> 01:39:24,560 NOT NECESSARILY DOING THIS OUT 1877 01:39:24,560 --> 01:39:29,120 OF THE KINDNESS OF THEIR HEART 1878 01:39:29,120 --> 01:39:29,720 THAT TO HAVE A REASON TO MAKE 1879 01:39:29,720 --> 01:39:31,680 THESE TRIALS SUCCESSFUL 1880 01:39:31,680 --> 01:39:37,680 LONG-TERM AND TO HAVE THEM BE 1881 01:39:37,680 --> 01:39:38,160 ABLE TO COUNT ON IF THEY 1882 01:39:38,160 --> 01:39:44,320 CREATE A DEVICE THAT THEY WILL 1883 01:39:44,320 --> 01:39:46,360 NOT LOSE OUT ON WHATEVER 1884 01:39:46,360 --> 01:39:46,600 BUSINESS. 1885 01:39:46,600 --> 01:39:51,680 SO THAT WAS THAT YOU NEED THE 1886 01:39:51,680 --> 01:39:53,680 DEVICE PEOPLE TO STICK AROUND 1887 01:39:53,680 --> 01:39:56,400 YOU NEED PARTICIPANTS TO BE 1888 01:39:56,400 --> 01:40:00,880 REPRESENTED AND YOU NEED 1889 01:40:00,880 --> 01:40:02,960 OUTSIDE SOURCES TO GET ALL OF 1890 01:40:02,960 --> 01:40:08,520 THE DATA THAT THEY NEED AND 1891 01:40:08,520 --> 01:40:09,120 INCENTIVES ARE REALLY THE ONLY 1892 01:40:09,120 --> 01:40:09,720 LANGUAGE THAT I KNOW OF HOW TO 1893 01:40:09,720 --> 01:40:13,040 GET THAT COMMUNICATED. 1894 01:40:13,040 --> 01:40:19,200 I THAT HELPS TO CLARIFY. 1895 01:40:19,200 --> 01:40:19,800 >> I WOULD LIKE TO TAKE A FEW 1896 01:40:19,800 --> 01:40:22,960 SECONDS TO ADD ON. 1897 01:40:22,960 --> 01:40:29,360 WHEN YOU LOOK AT INCENTIVES 1898 01:40:29,360 --> 01:40:29,960 WHEN WE ARE DESIGNING CLINICAL 1899 01:40:29,960 --> 01:40:30,480 TRIALS IS MAPPING OUT THE 1900 01:40:30,480 --> 01:40:31,240 PATIENT JOURNEY INTO HAVE AN 1901 01:40:31,240 --> 01:40:34,760 IDEA WHERE THE PAIN POINTS ARE 1902 01:40:34,760 --> 01:40:36,480 AND WHAT ARE THEIR MOTIVATIONS 1903 01:40:36,480 --> 01:40:40,680 FOR JOINING THE TRIALS THAT IS 1904 01:40:40,680 --> 01:40:41,320 THE INCENTIVE NOT NECESSARILY 1905 01:40:41,320 --> 01:40:44,040 THE FINE LINE OF PAYMENT BUT A 1906 01:40:44,040 --> 01:40:45,520 LOT OF INCENTIVES AND 1907 01:40:45,520 --> 01:40:51,600 DIFFERENT FORMATS AND THEN 1908 01:40:51,600 --> 01:40:54,000 GOING INTO PUBLICATIONS IT'S 1909 01:40:54,000 --> 01:40:56,120 IMPORTANT NOT TO PUBLISH ONLY 1910 01:40:56,120 --> 01:40:57,720 NOT WHAT WENT WRONG BUT WHAT 1911 01:40:57,720 --> 01:41:04,800 WENT RIGHT SO WHAT YOU ARE 1912 01:41:04,800 --> 01:41:08,440 DEVELOPING IS ALIGNING TO BE 1913 01:41:08,440 --> 01:41:13,880 ADDRESSED AMONG THE POPULATION 1914 01:41:13,880 --> 01:41:14,440 SO PUBLISHING THAT DATA IS 1915 01:41:14,440 --> 01:41:15,040 INCREDIBLY IMPORTANT NOT JUST 1916 01:41:15,040 --> 01:41:16,760 FOR THE SCIENTIFIC COMMUNITY 1917 01:41:16,760 --> 01:41:19,320 BUT THE LAY COMMUNITY AS WELL 1918 01:41:19,320 --> 01:41:23,760 BECAUSE TO TAKE US TO THE 1919 01:41:23,760 --> 01:41:24,360 PRIMARY CARE NOT ALWAYS UP ON 1920 01:41:24,360 --> 01:41:25,800 THE RESEARCH OF CONDITIONS IS 1921 01:41:25,800 --> 01:41:26,760 SOMETHING WE CAN BRING FORWARD 1922 01:41:26,760 --> 01:41:31,280 TO IT SCIENCE IS DOING TO HAVE 1923 01:41:31,280 --> 01:41:34,440 AN INFORMED CONVERSATION WITH 1924 01:41:34,440 --> 01:41:36,920 YOUR CLINICIAN AND THEN 1925 01:41:36,920 --> 01:41:39,040 FINALLY AN INCREDIBLY 1926 01:41:39,040 --> 01:41:42,880 IMPORTANT POINT TO EVEN WITH 1927 01:41:42,880 --> 01:41:48,000 THE PROSTHETIC STUDIES AND 1928 01:41:48,000 --> 01:41:49,520 YEARS AGO TO GET THEIR 1929 01:41:49,520 --> 01:41:53,080 PERSPECTIVE THAT THEY WERE 1930 01:41:53,080 --> 01:41:54,360 JOINING THE REGISTRY 1931 01:41:54,360 --> 01:41:56,720 VOLUNTARILY THEY COULD DO SO 1932 01:41:56,720 --> 01:41:58,560 WITH BACKGROUND INFORMATION TO 1933 01:41:58,560 --> 01:42:01,200 REALLY UNDERSTAND WHAT WENT 1934 01:42:01,200 --> 01:42:05,320 WRONG AND WHAT WENT WELL SO WE 1935 01:42:05,320 --> 01:42:11,440 CAN LEARN FROM PREVIOUS TRIALS. 1936 01:42:11,440 --> 01:42:12,040 >> WE ARE AT TIME THAT I WAS 1937 01:42:12,040 --> 01:42:12,480 HOPING WE COULD EXTEND 1938 01:42:12,480 --> 01:42:14,080 DISCUSSION FOR ANOTHER TEN 1939 01:42:14,080 --> 01:42:16,920 MINUTES BECAUSE THE 1940 01:42:16,920 --> 01:42:25,520 PRESENTATIONS RAN LONG. 1941 01:42:25,520 --> 01:42:26,120 WE STILL HAVE A 35 MINUTES OF 1942 01:42:26,120 --> 01:42:26,640 BREAK I AM HOPING WE CAN 1943 01:42:26,640 --> 01:42:27,160 CONTINUE THIS DISCUSSION A 1944 01:42:27,160 --> 01:42:33,720 LITTLE LONGER. 1945 01:42:33,720 --> 01:42:40,680 >> SO ONE QUESTION I WANTED TO 1946 01:42:40,680 --> 01:42:44,360 POST TO THE PANELIST IS THAT 1947 01:42:44,360 --> 01:42:49,400 INFORMATION GATHERING DIALOGUE 1948 01:42:49,400 --> 01:42:51,960 ONE OF THE NEEDS THAT WAS 1949 01:42:51,960 --> 01:42:55,080 RAISED WAS RELATED TO DEVICE 1950 01:42:55,080 --> 01:42:59,360 EXPECTATION OR TO THE MEDICAL 1951 01:42:59,360 --> 01:43:03,040 INDICATIONS SO WE WANTED TO 1952 01:43:03,040 --> 01:43:04,040 GET THE PANELIST THOUGHTS IF 1953 01:43:04,040 --> 01:43:08,600 THAT RESONATES AND THE 1954 01:43:08,600 --> 01:43:09,560 THOUGHTS AROUND THAT 1955 01:43:09,560 --> 01:43:16,840 PARTICULAR MISTRIAL NEED. 1956 01:43:16,840 --> 01:43:21,600 >> SO WERE HAPPY TO JUMP IN TO 1957 01:43:21,600 --> 01:43:29,000 THE PARTICIPANTS OF THE 1958 01:43:29,000 --> 01:43:29,560 STUDIES SO ONE ISSUE IS WHEN 1959 01:43:29,560 --> 01:43:33,760 THEY ARE GOING IN I'M HOPEFUL 1960 01:43:33,760 --> 01:43:37,400 THAT THIS WILL WORK FIRST ON 1961 01:43:37,400 --> 01:43:38,000 WILL SAY I DON'T KNOW IF IT'S 1962 01:43:38,000 --> 01:43:41,160 GOING TO WORK BUT THEY'RE NOT 1963 01:43:41,160 --> 01:43:43,560 THINKING OF HAVING THE DEVICE 1964 01:43:43,560 --> 01:43:45,200 REMOVED AND I HAVE SEEN SOME 1965 01:43:45,200 --> 01:43:49,080 DISCUSSIONS SO THIS CREATES AN 1966 01:43:49,080 --> 01:43:54,400 INTERESTING RELATIONSHIP AND 1967 01:43:54,400 --> 01:43:57,760 THAT YOU WILL BE IN THIS 1968 01:43:57,760 --> 01:43:58,280 PATIENT'S BRAIN FOR THE 1969 01:43:58,280 --> 01:44:02,320 DURATION OF THEIR LIFETIME SO 1970 01:44:02,320 --> 01:44:10,040 TO CREATE A LINK PLUS WITH THE 1971 01:44:10,040 --> 01:44:10,640 DEVICE TO CREATE A CONNECTION 1972 01:44:10,640 --> 01:44:12,680 THAT WILL LAST A LIFETIME AND 1973 01:44:12,680 --> 01:44:18,400 THE LIFETIME OF THE PATIENT. 1974 01:44:18,400 --> 01:44:23,480 SO I HAVE SEEN SOME PEOPLE SAY 1975 01:44:23,480 --> 01:44:24,040 THEN WE SHOULD REMOVE THE 1976 01:44:24,040 --> 01:44:26,120 DEVICE OR OFFER TO REMOVE THE 1977 01:44:26,120 --> 01:44:29,880 DEVICE WHICH OBVIOUSLY THEY 1978 01:44:29,880 --> 01:44:31,960 HAVE TO PROVIDE CONSENT BUT 1979 01:44:31,960 --> 01:44:38,800 THERE ARE CONCERNS ABOUT THE 1980 01:44:38,800 --> 01:44:40,920 SURGERY AND WHEN PATIENTS DO 1981 01:44:40,920 --> 01:44:46,640 WANT THE DEVICE REMOVED AND IF 1982 01:44:46,640 --> 01:44:47,160 IT IS SAFE TO REMOVE THE 1983 01:44:47,160 --> 01:44:49,440 DEVICE THERE IS A NUMBER OF 1984 01:44:49,440 --> 01:44:49,800 CONSIDERATIONS. 1985 01:44:49,800 --> 01:44:53,720 BUT WE ONLY HEARD OF ONE GROUP 1986 01:44:53,720 --> 01:44:55,880 THAT IS ACTUALLY REQUESTING 1987 01:44:55,880 --> 01:44:58,080 FUNDS TO NIH TO HAVE ONE OR 1988 01:44:58,080 --> 01:45:02,560 TWO DEVICE REMOVALS. 1989 01:45:02,560 --> 01:45:03,120 PEOPLE ARE THINKING ABOUT IT 1990 01:45:03,120 --> 01:45:03,720 AND IT IS POSSIBLE TO REQUEST 1991 01:45:03,720 --> 01:45:08,480 THOSE FUNDS AS I UNDERSTAND 1992 01:45:08,480 --> 01:45:09,080 , BUT IT'S NOT SOMETHING THAT 1993 01:45:09,080 --> 01:45:15,160 PEOPLE ARE OFTEN DOING BECAUSE 1994 01:45:15,160 --> 01:45:17,120 THAT THEN IN THAT SENSE THAT 1995 01:45:17,120 --> 01:45:23,360 THEY MAY NEED THOSE FUNDS. 1996 01:45:23,360 --> 01:45:29,600 >> THAT IS A GREAT POINT. 1997 01:45:29,600 --> 01:45:30,120 IT CAME UP DURING THE PRE- 1998 01:45:30,120 --> 01:45:30,720 INTERVIEWS IN PREPARATION FOR 1999 01:45:30,720 --> 01:45:34,480 THIS MEETING WITH THE BRAIN 2000 01:45:34,480 --> 01:45:35,800 COMPUTER INTERFACE 2001 01:45:35,800 --> 01:45:39,000 PARTICIPANTS BUT MAYBE THEY 2002 01:45:39,000 --> 01:45:49,480 WERE NOT READY AT THAT TIME. 2003 01:45:51,240 --> 01:45:56,440 AND THEN THE FUNDS RUN OUT. 2004 01:45:56,440 --> 01:45:57,000 AND THEN PUTTING ASIDE FUNDS 2005 01:45:57,000 --> 01:46:07,360 FOR THE INDIVIDUAL. 2006 01:46:08,960 --> 01:46:10,920 AND THEN CONCERNS TO HAVE A 2007 01:46:10,920 --> 01:46:14,400 VERY QUICK DECISION EVEN 2008 01:46:14,400 --> 01:46:15,240 THOUGH IT MAY HAVE BEEN 2009 01:46:15,240 --> 01:46:20,720 BROUGHT FORWARD HOW DOES 2010 01:46:20,720 --> 01:46:23,520 SOMEBODY PREPARE FOR THAT AND 2011 01:46:23,520 --> 01:46:31,280 BE EMPATHETIC AND WHAT IS THE 2012 01:46:31,280 --> 01:46:32,600 DECISION TREE OR THE 2013 01:46:32,600 --> 01:46:36,760 CONTINGENCY FOR A TRIAL 2014 01:46:36,760 --> 01:46:38,240 PARTICIPANT? 2015 01:46:38,240 --> 01:46:44,240 >> AND WITH THOSE SOLUTIONS 2016 01:46:44,240 --> 01:46:44,800 THAT ARE OFFERED NOW AND TO 2017 01:46:44,800 --> 01:46:47,480 MAKE THE POINT THAT ONLY THE 2018 01:46:47,480 --> 01:46:56,760 LATER PANELS AND MAKING USE OF 2019 01:46:56,760 --> 01:46:59,640 THOSE DEVICE USERS AND 2020 01:46:59,640 --> 01:47:02,120 SOMETHING WE ALL WANT TO 2021 01:47:02,120 --> 01:47:05,680 DISCUSS. 2022 01:47:05,680 --> 01:47:09,640 SARAH AND ON —- SARAH? 2023 01:47:09,640 --> 01:47:10,080 >> THIS IS FANTASTIC. 2024 01:47:10,080 --> 01:47:12,400 IT SEEMS THAT THE THREE PEOPLE 2025 01:47:12,400 --> 01:47:16,680 WHO ARE HERE TALKING ABOUT THE 2026 01:47:16,680 --> 01:47:17,280 TRIALS IT HAS BEEN WONDERFUL 2027 01:47:17,280 --> 01:47:19,120 TO HEAR YOUR PERSPECTIVE. 2028 01:47:19,120 --> 01:47:24,920 ALL PEOPLE WHO ARE WITH YOU 2029 01:47:24,920 --> 01:47:27,320 DAY BY DAY BENEFIT YOU DAY BY 2030 01:47:27,320 --> 01:47:28,760 DAY? 2031 01:47:28,760 --> 01:47:30,600 NEURAL DEVICE STUDIES ARE 2032 01:47:30,600 --> 01:47:36,880 DIFFERENT WINSTON'S GROUP SO 2033 01:47:36,880 --> 01:47:41,120 IS THERE ANYTHING DIFFERENT 2034 01:47:41,120 --> 01:47:41,600 ABOUT WHAT IS OWED TO A 2035 01:47:41,600 --> 01:47:42,720 PARTICIPANT IN TERMS OF 2036 01:47:42,720 --> 01:47:48,880 MAINTENANCE OR UPKEEP TO 2037 01:47:48,880 --> 01:47:49,440 CONTINUE BENEFITS IF THEY 2038 01:47:49,440 --> 01:47:54,240 MAINLY USE THE DEVICE IN WAYS 2039 01:47:54,240 --> 01:47:55,720 THAT ARE VERY BENEFICIAL IN A 2040 01:47:55,720 --> 01:48:01,640 LAB SETTING? 2041 01:48:01,640 --> 01:48:02,120 THE DEVICE IS STILL IN 2042 01:48:02,120 --> 01:48:02,680 SOMEBODY SAID THAT MAYBE THE 2043 01:48:02,680 --> 01:48:03,280 ONLY MAKE USE OF IT IN THE LAB 2044 01:48:03,280 --> 01:48:06,440 SETTING BUT A LOT OF THIS 2045 01:48:06,440 --> 01:48:16,680 STUDIES THEY ARE THERE IT IS A 2046 01:48:16,680 --> 01:48:17,240 LONG-TERM INVESTMENT PEOPLE 2047 01:48:17,240 --> 01:48:17,760 ARE MAKING AND THEY GAIN 2048 01:48:17,760 --> 01:48:20,840 ABILITIES IN THAT CONTEXT IS 2049 01:48:20,840 --> 01:48:25,240 IT DIFFERENT ARE NOT DIFFERENT 2050 01:48:25,240 --> 01:48:28,920 YOUR CASES ARE SO COMPELLING 2051 01:48:28,920 --> 01:48:31,480 BRANDY AND TYLER SAY IT IS 2052 01:48:31,480 --> 01:48:33,160 LIFE-SAVING. 2053 01:48:33,160 --> 01:48:33,720 I DON'T SEE HOW ANYBODY CAN 2054 01:48:33,720 --> 01:48:38,240 NOT RESPOND TO THAT CLAIM. 2055 01:48:38,240 --> 01:48:38,840 BUT FOR OTHER PEOPLE THAT MAY 2056 01:48:38,840 --> 01:48:44,280 NOT BE SO LIFE-SAVING AS LIFE 2057 01:48:44,280 --> 01:48:50,840 ALTERING SO DO WE THINK THAT 2058 01:48:50,840 --> 01:48:54,720 TRIAL MATTERS ARE THE KIND OF 2059 01:48:54,720 --> 01:48:59,800 BENEFIT THEY ARE GETTING? 2060 01:48:59,800 --> 01:49:07,720 >> AND I YIELD BACK TO LOSS OF 2061 01:49:07,720 --> 01:49:09,040 FUNCTION AND THEN TO 2062 01:49:09,040 --> 01:49:11,360 COMMUNICATE WITH THEIR 2063 01:49:11,360 --> 01:49:13,560 CAREGIVER AND THEN TO APPLAUD 2064 01:49:13,560 --> 01:49:20,840 ONE OF THE STUDIES BECAUSE 2065 01:49:20,840 --> 01:49:21,800 THEY GAVE HER ANOTHER 2066 01:49:21,800 --> 01:49:25,480 COMMUNICATION TOOL SO THAT WAS 2067 01:49:25,480 --> 01:49:27,600 THINKING OF THE CONTINGENCY 2068 01:49:27,600 --> 01:49:33,280 PLANS SO WHAT IS THE NEXT STEP 2069 01:49:33,280 --> 01:49:33,880 AND THEN SUDDENLY THEY LOSE 2070 01:49:33,880 --> 01:49:37,440 THE ABILITY TO COMMUNICATE SO 2071 01:49:37,440 --> 01:49:41,720 THAT WILL BE DIFFERENT PER 2072 01:49:41,720 --> 01:49:43,240 TRIAL BUT LOOKING AT THOSE 2073 01:49:43,240 --> 01:49:45,760 TREATMENT OPTIONS ARE AND 2074 01:49:45,760 --> 01:49:52,920 WORKING WITH THE PARTICIPANTS 2075 01:49:52,920 --> 01:49:53,480 BUT THERE ARE GUIDELINES WE 2076 01:49:53,480 --> 01:49:58,640 CAN DO IN THE DEVELOPMENT IT 2077 01:49:58,640 --> 01:50:06,560 IS LIFE-THREATENING FOR THOSE 2078 01:50:06,560 --> 01:50:07,120 WITHOUT TREATMENT RESISTANT 2079 01:50:07,120 --> 01:50:07,640 DEPRESSION BUT THEN THE 2080 01:50:07,640 --> 01:50:08,200 ABILITY TO FEED YOURSELF IF 2081 01:50:08,200 --> 01:50:10,400 YOU ARE A QUADRIPLEGIC SO ALL 2082 01:50:10,400 --> 01:50:13,160 OF THOSE DIFFERENT FUNCTIONS 2083 01:50:13,160 --> 01:50:15,720 APPROACH PEOPLE IN DIFFERENT 2084 01:50:15,720 --> 01:50:20,360 WAYS. 2085 01:50:20,360 --> 01:50:26,560 >> SO WHAT IS REEMERGING IS 2086 01:50:26,560 --> 01:50:31,400 THE IMPORTANCE OF MAPPING AND 2087 01:50:31,400 --> 01:50:37,840 TO PARTICIPATE IN THIS TRIAL 2088 01:50:37,840 --> 01:50:38,440 AND WHAT MY LIFE AS A PATIENT 2089 01:50:38,440 --> 01:50:40,640 OF THIS DEVICE LOOKS LIKE THAT 2090 01:50:40,640 --> 01:50:41,520 SOMETHING WE HEAR CAREGIVERS 2091 01:50:41,520 --> 01:50:49,200 SPRING UP OR PARTNERS. 2092 01:50:49,200 --> 01:50:49,760 BUT THEY ALSO BRING THAT UP 2093 01:50:49,760 --> 01:50:55,000 THAT WOULD BE HELPFUL OF HOW 2094 01:50:55,000 --> 01:51:00,040 THINGS WILL LOOK LIKE BECAUSE 2095 01:51:00,040 --> 01:51:05,360 THEY ARE INVOLVED IN THE CARE 2096 01:51:05,360 --> 01:51:06,440 AND I CAN BE IN A SITUATION AT 2097 01:51:06,440 --> 01:51:10,440 THE MOMENT WHERE THEY WILL 2098 01:51:10,440 --> 01:51:13,680 PROVIDE CONSENT THINKING OF 2099 01:51:13,680 --> 01:51:20,320 MANY THINGS AND WITH TREATMENT 2100 01:51:20,320 --> 01:51:23,160 SEARCH FATIGUE AND A LONG 2101 01:51:23,160 --> 01:51:26,520 PROCESS THEY HAVE TRIED TO 2102 01:51:26,520 --> 01:51:27,000 FIND SOMETHING AND FIND 2103 01:51:27,000 --> 01:51:27,880 SOMETHING AND THEN YOU GET TO 2104 01:51:27,880 --> 01:51:32,040 THE POINT YOU ARE UNDERGOING 2105 01:51:32,040 --> 01:51:35,480 30 PAGE RESEARCH COORDINATOR 2106 01:51:35,480 --> 01:51:35,840 IT'S A DOCUMENT. 2107 01:51:35,840 --> 01:51:36,360 I'M ALSO A LAWYER I HAVE 2108 01:51:36,360 --> 01:51:41,720 LOOKED AT THIS AND I TRY TO 2109 01:51:41,720 --> 01:51:46,280 FIND AND THEN TO FIND OUT WHAT 2110 01:51:46,280 --> 01:51:50,520 WILL HAPPEN BUT AT THE END OF 2111 01:51:50,520 --> 01:51:55,360 THE TRIAL YOU ARE THE 2112 01:51:55,360 --> 01:52:00,720 INSURANCE PROVIDER BUT IT'S 2113 01:52:00,720 --> 01:52:06,920 EVENT HARD TO IDENTIFY AND 2114 01:52:06,920 --> 01:52:07,520 THAT THEY DON'T COVER IT THEN 2115 01:52:07,520 --> 01:52:08,560 I HAVE TO PAY FOR THAT IS A 2116 01:52:08,560 --> 01:52:12,840 PARTICIPANT THEN MANY TIMES 2117 01:52:12,840 --> 01:52:15,280 THAT IS WHAT THE DOCUMENT IS 2118 01:52:15,280 --> 01:52:17,200 SAYING. 2119 01:52:17,200 --> 01:52:17,760 THERE IS SO MUCH INFORMATION 2120 01:52:17,760 --> 01:52:23,560 THEY HAVE TO PROCESS AND THEN 2121 01:52:23,560 --> 01:52:25,720 TO ILLUSTRATE WHAT THIS WOULD 2122 01:52:25,720 --> 01:52:33,960 LOOK LIKE WITH A TRAJECTORY 2123 01:52:33,960 --> 01:52:37,600 BUT ALSO WITH CARE PARTNERS IN 2124 01:52:37,600 --> 01:52:44,720 THAT CONSENT PROCESS AND I 2125 01:52:44,720 --> 01:52:45,320 KNOW THAT THE RESEARCHERS TRY 2126 01:52:45,320 --> 01:52:49,080 TO DO THIS BUT MAYBE MORE 2127 01:52:49,080 --> 01:52:51,480 STRUCTURED WAYS TO INVOLVED IN 2128 01:52:51,480 --> 01:53:00,560 THE PROCESS. 2129 01:53:00,560 --> 01:53:01,160 >> THIS HAS BEEN A GREAT PANEL 2130 01:53:01,160 --> 01:53:01,680 AND A GREAT WAY TO END. 2131 01:53:01,680 --> 01:53:04,080 JUST A REMINDER THAT 2132 01:53:04,080 --> 01:53:04,560 TREMENDOUS DIVERSITY OF 2133 01:53:04,560 --> 01:53:05,120 DIFFERENT STUDIES THAT ARE 2134 01:53:05,120 --> 01:53:08,760 BEING DONE. 2135 01:53:08,760 --> 01:53:09,200 AND THOSE OF PATIENT 2136 01:53:09,200 --> 01:53:13,800 PARTICIPANTS AND TRIALS AND A 2137 01:53:13,800 --> 01:53:14,320 DIFFERENT SITUATIONS OF 2138 01:53:14,320 --> 01:53:17,240 RESEARCH TEAMS AND THAT'S THE 2139 01:53:17,240 --> 01:53:19,920 GREAT WAY TO GO INTO THE 2140 01:53:19,920 --> 01:53:21,280 DISCUSSION. 2141 01:53:21,280 --> 01:53:25,280 WITH THAT DIVERSITY THAT IS 2142 01:53:25,280 --> 01:53:26,720 SOMETHING WE WILL NEED TO KEEP 2143 01:53:26,720 --> 01:53:28,800 DISCUSSING I HOPE THE PANELIST 2144 01:53:28,800 --> 01:53:34,040 WILL STICK AROUND AND THAT 2145 01:53:34,040 --> 01:53:37,160 THESE VOICES HAVE BEEN SO 2146 01:53:37,160 --> 01:53:37,760 POWERFUL AND WE GOT SO MUCH 2147 01:53:37,760 --> 01:53:40,360 FROM THE DISCUSSION. 2148 01:53:40,360 --> 01:53:50,760 THANK YOU TO OUR PANEL. 2149 01:53:53,720 --> 01:54:00,120 NOW WE WILL GO TO A BREAK WE 2150 01:54:00,120 --> 01:54:04,840 WILL START THE SECOND PANEL AT 2151 01:54:04,840 --> 01:54:05,120 2:30 P.M. 2152 01:54:05,120 --> 01:54:07,600 WE WILL SEE YOU THERE. 2153 01:54:07,600 --> 01:54:08,520 WELCOME BACK, EVERYBODY. 2154 01:54:08,520 --> 01:54:11,520 I HOPE YOU HAD A GOOD BREAK. 2155 01:54:11,520 --> 01:54:15,120 IT'S MY PLEASURE TO ANNOUNCE THE 2156 01:54:15,120 --> 01:54:17,440 SECOND PANEL THIS AFTERNOON. 2157 01:54:17,440 --> 01:54:18,920 WHICH IS FOCUSING ON WHAT 2158 01:54:18,920 --> 01:54:20,480 DIFFERENT STAKEHOLDER GROUPS 2159 01:54:20,480 --> 01:54:22,360 CURRENTLY PROVIDE AND WHAT THEY 2160 01:54:22,360 --> 01:54:25,120 CAN OR COULD PROVIDE IN TERMS OF 2161 01:54:25,120 --> 01:54:26,240 THE RESEARCH-RELATED CARE NEEDS 2162 01:54:26,240 --> 01:54:28,720 THAT WE SO POWERFULLY HEARD 2163 01:54:28,720 --> 01:54:29,600 ABOUT DURING PANEL ONE. 2164 01:54:29,600 --> 01:54:32,640 SO WITH THAT, I WOULD LIKE TO 2165 01:54:32,640 --> 01:54:34,360 GIVE IT OVER TO THE 2166 01:54:34,360 --> 01:54:39,600 CO-MODERATORS OF THIS SECOND 2167 01:54:39,600 --> 01:54:49,440 PANEL, WHICH ARE DR. SHAMIR AND 2168 01:54:49,440 --> 01:54:51,320 DR. HSU. 2169 01:54:51,320 --> 01:54:55,360 >> WE'LL KICK IT OFF AND AFTER 2170 01:54:55,360 --> 01:54:59,120 THIS WE'LL HAVE A PANEL 2171 01:54:59,120 --> 01:55:01,440 PRESENTATIONS FIRST SPEAKER IS 2172 01:55:01,440 --> 01:55:05,920 DR. YAGNA PATHAK, ENGAGING IN 2173 01:55:05,920 --> 01:55:07,040 TRANSLATIONAL RESEARCH FOCUSED 2174 01:55:07,040 --> 01:55:08,320 ON LEVERAGING DIGITAL HEALTH 2175 01:55:08,320 --> 01:55:09,960 TOOLS TO IMPROVE THE CLINICAL 2176 01:55:09,960 --> 01:55:12,960 APPLICATION OF NEUROMODULATION 2177 01:55:12,960 --> 01:55:13,400 THERAPY. 2178 01:55:13,400 --> 01:55:17,440 PRIOR TO HER CURRENT ROLE WE 2179 01:55:17,440 --> 01:55:22,480 INVESTIGATED NEUROMODULAR FOR 2180 01:55:22,480 --> 01:55:25,080 DISEASES AND PH.D. FROM 2181 01:55:25,080 --> 01:55:27,720 MARQUETTE UNIVERSITY FROM 2182 01:55:27,720 --> 01:55:29,040 DR. CHRISTOPHER HUDSON AND 2183 01:55:29,040 --> 01:55:30,400 FELLOWSHIP COLUMBIA UNIVERSITY 2184 01:55:30,400 --> 01:55:31,400 WORKING WITH DR. SHAMIR SHA. 2185 01:55:31,400 --> 01:55:35,520 THANK YOU, SHERRY AND THANK YOU, 2186 01:55:35,520 --> 01:55:35,680 ALL. 2187 01:55:35,680 --> 01:55:36,680 SHERRY, I THINK YOU CAN MOVE ON 2188 01:55:36,680 --> 01:55:39,680 TO THE NEXT SLIDE, PLEASE. 2189 01:55:39,680 --> 01:55:42,920 SO I REALLY JUST WANTED TO TALK 2190 01:55:42,920 --> 01:55:45,800 ABOUT WE HEARD A NUMBER OF TALKS 2191 01:55:45,800 --> 01:55:48,440 THIS MORNING FROM PATIENTS AT 2192 01:55:48,440 --> 01:55:50,760 THE PATIENT ADVOCATE GROUP BUT 2193 01:55:50,760 --> 01:55:52,120 THE KEY STAKEHOLDERS OF THE 2194 01:55:52,120 --> 01:55:54,040 SITUATION INCLUDE INDUSTRY 2195 01:55:54,040 --> 01:55:55,400 SPONSORS, REGULATORY AND 2196 01:55:55,400 --> 01:55:56,600 REIMBURSEMENT BODIES AS WELL AS 2197 01:55:56,600 --> 01:55:57,560 CLINICAL TEAMS BUT MOST 2198 01:55:57,560 --> 01:55:59,680 IMPORTANTLY WE NEED TO RECOGNIZE 2199 01:55:59,680 --> 01:56:00,680 THAT PATIENTS ARE STILL AT THE 2200 01:56:00,680 --> 01:56:01,240 CENTER HERE. 2201 01:56:01,240 --> 01:56:02,520 THE BURDEN OF RESPONSIBILITY MAY 2202 01:56:02,520 --> 01:56:04,640 DEFER BASED ON THE TYPE OF STUDY 2203 01:56:04,640 --> 01:56:06,640 THAT WE'RE TALKING ABOUT BUT THE 2204 01:56:06,640 --> 01:56:08,840 EFFORT SHOULD BE TO WORK IN A 2205 01:56:08,840 --> 01:56:10,520 COLLABORATIVE WAY TO BEST 2206 01:56:10,520 --> 01:56:12,880 SUPPORT PATIENT CARE. 2207 01:56:12,880 --> 01:56:17,480 NEXT SLIDE, PLEASE. 2208 01:56:17,480 --> 01:56:18,600 SO CURRENT ITEMS FOR TREATMENT 2209 01:56:18,600 --> 01:56:20,440 ACCESS BEYOND THE DURATION OF 2210 01:56:20,440 --> 01:56:21,880 THE CLINICAL TRIAL REALLY COMES 2211 01:56:21,880 --> 01:56:22,840 FROM TWO SPECIFIC DOCUMENTS. 2212 01:56:22,840 --> 01:56:28,640 THE DECLARATION OF HELSINKI AND 2213 01:56:28,640 --> 01:56:30,680 THE GUIDELINES BY WHO. 2214 01:56:30,680 --> 01:56:31,960 THE DOCUMENTS ACCOUNT FOR 2215 01:56:31,960 --> 01:56:34,400 ASSESSMENTS OF WHETHER THE 2216 01:56:34,400 --> 01:56:37,160 TREATMENT IS EFFECTIVE AND HOW 2217 01:56:37,160 --> 01:56:38,160 PATIENTS WERE PREPPED FOR 2218 01:56:38,160 --> 01:56:40,840 PATIENTS BEYOND THE TRIAL. 2219 01:56:40,840 --> 01:56:44,360 AND SO IF EVERYTHING IS IDEAL, 2220 01:56:44,360 --> 01:56:46,360 FOR A STUDY OUTCOME, THEN THESE 2221 01:56:46,360 --> 01:56:47,480 ARE SOME REALLY GREAT THINGS TO 2222 01:56:47,480 --> 01:56:48,880 THINK ABOUT. 2223 01:56:48,880 --> 01:56:53,280 SO WHAT IS AN IDEAL PATIENT 2224 01:56:53,280 --> 01:56:53,520 CONTINUUM. 2225 01:56:53,520 --> 01:56:55,040 NEXT SLIDE. 2226 01:56:55,040 --> 01:56:58,560 IDEALLY WE EXPECT IT TO BE A 2227 01:56:58,560 --> 01:57:00,160 NEAR PROCESS WITH CERTAIN 2228 01:57:00,160 --> 01:57:00,440 PROCESSES. 2229 01:57:00,440 --> 01:57:01,960 THIS JOURNEY STARTS WITH THE 2230 01:57:01,960 --> 01:57:03,800 PATIENT PARTICIPATION IN A 2231 01:57:03,800 --> 01:57:05,200 CLINICAL TRIAL FOLLOWED BY OUR 2232 01:57:05,200 --> 01:57:07,400 REGULATORY APPROVAL AND 2233 01:57:07,400 --> 01:57:09,400 REIMBURSEMENT COVERAGE HOPEFULLY 2234 01:57:09,400 --> 01:57:11,000 LEADING TO A MARKET LAUNCH FOR 2235 01:57:11,000 --> 01:57:15,200 THE DEVICE OR THE SYSTEM SO THAT 2236 01:57:15,200 --> 01:57:16,280 THERAPY IS EVENTUALLY ACCESSIBLE 2237 01:57:16,280 --> 01:57:17,600 AS STANDARD OF CARE. 2238 01:57:17,600 --> 01:57:18,680 HOWEVER, THIS IS THE IDEAL 2239 01:57:18,680 --> 01:57:20,520 SCENARIO AND WE ALL KNOW THAT 2240 01:57:20,520 --> 01:57:22,000 SELDOM DO WE HAVE IDEAL 2241 01:57:22,000 --> 01:57:23,960 SCENARIOS IN REAL LIFE. 2242 01:57:23,960 --> 01:57:25,960 SO THE REALITY IS SOMETHING 2243 01:57:25,960 --> 01:57:28,440 COMPLETELY DIFFERENT. 2244 01:57:28,440 --> 01:57:31,120 NEXT SLIDE, PLEASE. 2245 01:57:31,120 --> 01:57:32,840 SO IN REALITY, THE PATIENT 2246 01:57:32,840 --> 01:57:35,960 JOURNEY IS NOT SO 2247 01:57:35,960 --> 01:57:36,320 STRAIGHTFORWARD. 2248 01:57:36,320 --> 01:57:37,840 WHAT REALLY HAPPENS WHEN, WHAT 2249 01:57:37,840 --> 01:57:39,240 HAPPENS WHEN REGULATORY APPROVAL 2250 01:57:39,240 --> 01:57:40,120 IS DELAYED? 2251 01:57:40,120 --> 01:57:42,440 THERE ARE CERTAIN OPTIONS FOR 2252 01:57:42,440 --> 01:57:44,280 CONTINUED PARTICIPATION IN OPEN 2253 01:57:44,280 --> 01:57:46,600 LABEL EXTENSION STUDIES OR EVEN 2254 01:57:46,600 --> 01:57:48,880 ROLLOVER CLINICAL TRIALS, IF 2255 01:57:48,880 --> 01:57:51,400 THIS SPONSOR WISHES TO CONDUCT 2256 01:57:51,400 --> 01:57:54,000 THESE ADDITIONAL EVIDENCE. 2257 01:57:54,000 --> 01:57:54,880 HOWEVER, THE OTHER POTENTIAL 2258 01:57:54,880 --> 01:57:56,640 OPTIONS THAT CURRENTLY EXIST 2259 01:57:56,640 --> 01:58:00,000 LIKE EXPANDED ACCESS ARE OFTEN 2260 01:58:00,000 --> 01:58:01,720 COUPLED WITH CONTINGENCIES 2261 01:58:01,720 --> 01:58:02,800 INVOLVING SEVERAL OF THE 2262 01:58:02,800 --> 01:58:04,240 STAKEHOLDERS THAT I MENTIONED 2263 01:58:04,240 --> 01:58:04,720 EARLIER. 2264 01:58:04,720 --> 01:58:07,760 AND SO OVERALL THERE'S REALLY A 2265 01:58:07,760 --> 01:58:09,120 LACK OF PROVISION FOR 2266 01:58:09,120 --> 01:58:12,800 INCONCLUSIVE STUDIES MAKING 2267 01:58:12,800 --> 01:58:13,800 THESE UNIDEAL SITUATIONS 2268 01:58:13,800 --> 01:58:15,400 CHALLENGING TO NAVIGATE. 2269 01:58:15,400 --> 01:58:16,280 WHAT HAPPENS WHEN REGULATORY 2270 01:58:16,280 --> 01:58:17,320 APPROVAL IS DELAYED. 2271 01:58:17,320 --> 01:58:18,600 WHAT HAPPENS IF A STUDY DOESN'T 2272 01:58:18,600 --> 01:58:21,560 REALLY MEET ITS PRIMARY 2273 01:58:21,560 --> 01:58:22,000 ENDPOINT? 2274 01:58:22,000 --> 01:58:23,760 WHAT ARE POTENTIAL OPTIONS AND 2275 01:58:23,760 --> 01:58:25,400 WHO REALLY BEARS THE BURDEN OF 2276 01:58:25,400 --> 01:58:26,120 RESPONSIBILITY HERE? 2277 01:58:26,120 --> 01:58:28,960 AND SO RIGHT NOW WE REALLY DO 2278 01:58:28,960 --> 01:58:30,680 NOT HAVE PROVISIONS TO KIND OF 2279 01:58:30,680 --> 01:58:36,680 ACCOUNT FOR THESE UNIDEAL 2280 01:58:36,680 --> 01:58:36,960 SITUATIONS. 2281 01:58:36,960 --> 01:58:38,440 NEXT SLIDE, PLEASE. 2282 01:58:38,440 --> 01:58:40,920 SO IN THIS LANDSCAPE, THERE 2283 01:58:40,920 --> 01:58:42,440 SHOULD BE CONSIDERATIONS FOR 2284 01:58:42,440 --> 01:58:43,960 CONTINUED CARE THAT REALLY COVER 2285 01:58:43,960 --> 01:58:46,040 CLINICAL NEEDS, TECHNOLOGY NEEDS 2286 01:58:46,040 --> 01:58:46,800 AND COVERAGE. 2287 01:58:46,800 --> 01:58:49,840 SO WE NEED TO ANSWER QUESTIONS 2288 01:58:49,840 --> 01:58:52,880 ABOUT HOSPITAL AND CLINICIAN 2289 01:58:52,880 --> 01:58:54,840 RESOURCES, SPECIFICALLY AROUND 2290 01:58:54,840 --> 01:58:56,040 INTEGRATING RESEARCH AND 2291 01:58:56,040 --> 01:58:57,640 INVESTIGATIONAL THERAPY IN 2292 01:58:57,640 --> 01:58:59,480 EXISTING PATHWAYS. 2293 01:58:59,480 --> 01:59:00,680 UNIQUE TO IMPLANTED DEVICES WE 2294 01:59:00,680 --> 01:59:03,160 ALSO NEED TO CONSIDER THE 2295 01:59:03,160 --> 01:59:04,240 CONSEQUENCES OF EXPLANTING A 2296 01:59:04,240 --> 01:59:06,360 DEVICE OR EXPLANTING A SYSTEM 2297 01:59:06,360 --> 01:59:08,680 VERSUS MAINTAINING OR REPLACING 2298 01:59:08,680 --> 01:59:10,680 THE SYSTEMS. 2299 01:59:10,680 --> 01:59:12,720 FROM A DEVELOPMENT PERSPECTIVE, 2300 01:59:12,720 --> 01:59:14,200 WE REALLY SHOULD BE THINKING 2301 01:59:14,200 --> 01:59:15,400 ABOUT HOW THESE INVESTIGATIONAL 2302 01:59:15,400 --> 01:59:17,920 DEVICES WILL INTERACT WITH 2303 01:59:17,920 --> 01:59:19,800 FUTURE SYSTEMS, WHAT HAPPENS TO 2304 01:59:19,800 --> 01:59:22,880 THE DATA BEYOND THE TRIAL, AND 2305 01:59:22,880 --> 01:59:25,000 LASTLY, WHAT IS COVERED, WHO 2306 01:59:25,000 --> 01:59:27,160 PAYS FOR WHICH PIECE, AND THAT 2307 01:59:27,160 --> 01:59:31,400 LAST PIECE IS ESPECIALLY 2308 01:59:31,400 --> 01:59:32,520 CHALLENGING IN LARGER CLINICAL 2309 01:59:32,520 --> 01:59:34,800 TRIALS THAT TEND TO BE MULTISITE 2310 01:59:34,800 --> 01:59:36,280 OR MULTIGEOGRAPHY BECAUSE 2311 01:59:36,280 --> 01:59:38,160 REIMBURSEMENT AND REGULATORY 2312 01:59:38,160 --> 01:59:41,320 RULES ARE OFTEN REGION SPECIFIC. 2313 01:59:41,320 --> 01:59:42,800 SO THESE ARE SOME BUCKET 2314 01:59:42,800 --> 01:59:46,040 CATEGORIES IN WHICH WE SHOULD BE 2315 01:59:46,040 --> 01:59:47,240 THINKING ABOUT CONTINUED CARE 2316 01:59:47,240 --> 01:59:50,640 AND HOW RESPONSIBILITIES SHOULD 2317 01:59:50,640 --> 01:59:55,320 BE DIVIDED FOR POST-TRIAL 2318 01:59:55,320 --> 01:59:55,560 ACCESS. 2319 01:59:55,560 --> 01:59:56,800 NEXT SLIDE, PLEASE. 2320 01:59:56,800 --> 01:59:58,760 SO REALLY THE QUESTION IS HOW 2321 01:59:58,760 --> 01:59:59,920 CAN WE DO BETTER? 2322 01:59:59,920 --> 02:00:01,640 AND I THINK THIS WORKSHOP IS A 2323 02:00:01,640 --> 02:00:03,000 REALLY GREAT INITIATIVE TOWARDS 2324 02:00:03,000 --> 02:00:05,680 SOLVING THIS PROBLEM BECAUSE WE 2325 02:00:05,680 --> 02:00:06,640 REALLY SHOULD BEGIN CLINICAL 2326 02:00:06,640 --> 02:00:08,880 TRIAL PLANNING WITH THE END IN 2327 02:00:08,880 --> 02:00:11,200 MIND. 2328 02:00:11,200 --> 02:00:12,400 SO AS OPTIMISTIC AS WE MIGHT 2329 02:00:12,400 --> 02:00:14,320 WANT TO BE WE SHOULD CONSIDER 2330 02:00:14,320 --> 02:00:15,680 ALL POTENTIAL OUTCOMES, EVEN IF 2331 02:00:15,680 --> 02:00:17,320 THOSE OUTCOMES ARE NOT ALWAYS 2332 02:00:17,320 --> 02:00:19,760 FAVORABLE OUTCOMES, BECAUSE 2333 02:00:19,760 --> 02:00:20,720 ULTIMATELY IT'S IN THOSE 2334 02:00:20,720 --> 02:00:23,080 SITUATIONS WHEN WE DO HAVE 2335 02:00:23,080 --> 02:00:23,920 UNFAVORABLE OUTCOMES WHERE THE 2336 02:00:23,920 --> 02:00:26,080 CHALLENGES ARE THE GREATEST AND 2337 02:00:26,080 --> 02:00:27,400 WE REALLY SHOULD BE ACCOUNTING 2338 02:00:27,400 --> 02:00:29,800 FOR WHAT IS BEST FOR THE PATIENT 2339 02:00:29,800 --> 02:00:32,280 AND I KNOW SOMEONE MENTIONED 2340 02:00:32,280 --> 02:00:34,240 THIS MORNING WHAT ARE INCENTIVES 2341 02:00:34,240 --> 02:00:36,880 FOR INDUSTRY SPONSORS, WHAT ARE 2342 02:00:36,880 --> 02:00:38,120 INCENTIVES FOR SOME OF THE OTHER 2343 02:00:38,120 --> 02:00:39,920 KEY STAKEHOLDERS INVOLVED, BUT I 2344 02:00:39,920 --> 02:00:40,880 DO ULTIMATELY BELIEVE THAT 2345 02:00:40,880 --> 02:00:44,680 EVERYONE IS IN THIS TO REALLY 2346 02:00:44,680 --> 02:00:47,400 IMPROVE THE OUTCOMES FOR 2347 02:00:47,400 --> 02:00:50,280 PATIENTS THAT WE ARE DEVELOPING 2348 02:00:50,280 --> 02:00:52,280 OUR TECHNOLOGIES FOR, THAT WE'RE 2349 02:00:52,280 --> 02:00:53,200 DEVELOPING OUR TREATMENTS FOR, 2350 02:00:53,200 --> 02:00:55,080 AND THAT WE ULTIMATELY WISH TO 2351 02:00:55,080 --> 02:00:55,360 SERVE. 2352 02:00:55,360 --> 02:00:57,440 SO WE REALLY SHOULD BE KIND OF 2353 02:00:57,440 --> 02:00:59,280 COMING BACK TO WHAT CAN WE DO TO 2354 02:00:59,280 --> 02:01:02,240 REALLY MAKE THIS A 2355 02:01:02,240 --> 02:01:03,080 PATIENT-CENTRIC APPROACH AND CAN 2356 02:01:03,080 --> 02:01:06,560 YOU START THINKING ABOUT SORT OF 2357 02:01:06,560 --> 02:01:08,880 THESE POTENTIAL OUTCOMES AT THE 2358 02:01:08,880 --> 02:01:11,840 BEGINNING OF THE CLINICAL TRIAL 2359 02:01:11,840 --> 02:01:12,680 PLANNING. 2360 02:01:12,680 --> 02:01:16,000 NEXT SLIDE, PLEASE. 2361 02:01:16,000 --> 02:01:19,400 AND SO FOR THAT WE CAN REALLY 2362 02:01:19,400 --> 02:01:22,720 START BY DEFINING THE PATIENT 2363 02:01:22,720 --> 02:01:23,720 CONTINUUM DURING PROTON 2364 02:01:23,720 --> 02:01:24,040 DEVELOPMENT. 2365 02:01:24,040 --> 02:01:25,960 WHAT DOES INFORMED CONSENT LOOK 2366 02:01:25,960 --> 02:01:26,240 LIKE? 2367 02:01:26,240 --> 02:01:26,960 HOW MANY PROCEDURES CAN WE 2368 02:01:26,960 --> 02:01:28,760 SUPPORT DURING THE TRIAL? 2369 02:01:28,760 --> 02:01:30,280 HOW MANY PROCEDURES CAN WE 2370 02:01:30,280 --> 02:01:31,160 SUPPORT BEYOND THE TRIAL? 2371 02:01:31,160 --> 02:01:33,800 WHAT ARE THE CONSEQUENCES TO THE 2372 02:01:33,800 --> 02:01:36,160 PATIENT IF THEY'RE ASKED TO 2373 02:01:36,160 --> 02:01:37,400 PARTICIPATE IN ADDITIONAL 2374 02:01:37,400 --> 02:01:37,640 RESEARCH? 2375 02:01:37,640 --> 02:01:40,280 HOW DO WE COMPLY WITH PRIVACY 2376 02:01:40,280 --> 02:01:42,160 AND SECURITY PRACTICES IF WE 2377 02:01:42,160 --> 02:01:43,840 NEED TO EXTEND DATA COLLECTION 2378 02:01:43,840 --> 02:01:44,880 BEYOND THE TRIAL? 2379 02:01:44,880 --> 02:01:47,800 SO WE HAD A PATIENT THIS MORNING 2380 02:01:47,800 --> 02:01:50,080 TALK ABOUT WHAT'S IN HER 2381 02:01:50,080 --> 02:01:51,400 CLINICAL HISTORY VERSUS REALLY 2382 02:01:51,400 --> 02:01:52,880 INFORMATION ABOUT HER TRIAL. 2383 02:01:52,880 --> 02:01:56,400 HOW DO WE BALANCE THE RESEARCH 2384 02:01:56,400 --> 02:01:57,320 CONTINUUM WITH CLINICAL 2385 02:01:57,320 --> 02:01:58,320 STANDARDS AND THAT SHOULD BE 2386 02:01:58,320 --> 02:02:00,920 SOMETHING THAT WE START PLANNING 2387 02:02:00,920 --> 02:02:03,160 FOR AND DEFINING DURING THE 2388 02:02:03,160 --> 02:02:04,920 PROTON DEVELOPMENT STAGE AND NOT 2389 02:02:04,920 --> 02:02:07,160 SORT OF AT THE END OF THE TRIAL 2390 02:02:07,160 --> 02:02:11,200 WHEN IT MIGHT BE TOO LATE TO ASK 2391 02:02:11,200 --> 02:02:13,240 FOR EXPANDED INFORMED CONSENT 2392 02:02:13,240 --> 02:02:15,000 FROM THESE PATIENTS OR TO 2393 02:02:15,000 --> 02:02:16,120 ALLOCATE MORE BUDGET. 2394 02:02:16,120 --> 02:02:17,960 AND SO THAT BRINGS US TO THE 2395 02:02:17,960 --> 02:02:19,720 NEXT POINT, WHICH IS FROM A 2396 02:02:19,720 --> 02:02:21,680 MINDSET PERSPECTIVE WE REALLY 2397 02:02:21,680 --> 02:02:27,920 NEED TO OPT FOR A PREVENTIVE OR 2398 02:02:27,920 --> 02:02:29,080 AN ANTICIPATORY APPROACH AND 2399 02:02:29,080 --> 02:02:31,400 ALIGNMENT WITH KEY STAKEHOLDERS 2400 02:02:31,400 --> 02:02:34,560 AND EXPLICIT DEFINITION ABOUT 2401 02:02:34,560 --> 02:02:36,080 POST TRIAL GROWTH AND BUDGET 2402 02:02:36,080 --> 02:02:39,480 BECAUSE WE ALL KNOW THAT THESE 2403 02:02:39,480 --> 02:02:43,360 TRIALS CAN BE VERY EXPENSIVE AND 2404 02:02:43,360 --> 02:02:47,000 IT'S AN INTRICATE PLAY BETWEEN A 2405 02:02:47,000 --> 02:02:47,880 LOT OF DIFFERENT PARTICIPANTS 2406 02:02:47,880 --> 02:02:49,840 THAT ARE ULTIMATELY TRYING TO 2407 02:02:49,840 --> 02:02:54,080 IMPROVE CARE FOR THE PATIENT. 2408 02:02:54,080 --> 02:02:55,440 HOWEVER, IF THERE ISN'T 2409 02:02:55,440 --> 02:02:56,880 SOMETHING DEFINED AHEAD OF TIME 2410 02:02:56,880 --> 02:02:58,200 THEN WHO SORT OF TAKES THE 2411 02:02:58,200 --> 02:03:00,760 BURDEN WHEN THE TIME FOR THAT 2412 02:03:00,760 --> 02:03:01,240 COMES TO. 2413 02:03:01,240 --> 02:03:04,720 SO I THINK A LOT OF THAT NEEDS 2414 02:03:04,720 --> 02:03:06,440 TO BE DEVELOPED FROM A 2415 02:03:06,440 --> 02:03:07,920 PREVENTIVE OR ANTICIPATORY 2416 02:03:07,920 --> 02:03:09,960 APPROACH THAT SHOULD WE HAVE 2417 02:03:09,960 --> 02:03:11,200 UNFAVORABLE OUTCOMES HOW DO WE 2418 02:03:11,200 --> 02:03:11,680 ACCOUNT FOR THAT? 2419 02:03:11,680 --> 02:03:15,040 AND LASTLY, WE NEED A THOROUGH 2420 02:03:15,040 --> 02:03:16,920 BUT ITERATIVE RISK BENEFIT 2421 02:03:16,920 --> 02:03:17,200 ASSESSMENT. 2422 02:03:17,200 --> 02:03:19,960 SO WE ALL KNOW FROM ALL OF OUR 2423 02:03:19,960 --> 02:03:22,400 EXPERIENCES THAT THERE ISN'T THE 2424 02:03:22,400 --> 02:03:23,840 ONE-SIZE-FITS-ALL FOR ALL 2425 02:03:23,840 --> 02:03:24,400 PARTICIPANTS. 2426 02:03:24,400 --> 02:03:25,840 ALL PARTICIPANTS MAY NOT BENEFIT 2427 02:03:25,840 --> 02:03:28,560 WITH THERAPY, AND SOME 2428 02:03:28,560 --> 02:03:29,680 PARTICIPANTS MAY HAVE 2429 02:03:29,680 --> 02:03:31,440 LIFE-CHANGING OUTCOMES AS WE 2430 02:03:31,440 --> 02:03:34,640 ALSO SAW THIS MORNING. 2431 02:03:34,640 --> 02:03:35,440 SO AS WE HAVE MORE INFORMATION 2432 02:03:35,440 --> 02:03:38,200 WE SHOULD REALLY STRIVE TO MAKE 2433 02:03:38,200 --> 02:03:40,720 DATA DRIVEN DECISIONS AND ADJUST 2434 02:03:40,720 --> 02:03:42,040 ACCORDING TO THE EVIDENCE THAT 2435 02:03:42,040 --> 02:03:42,920 WE HAVE AT HAND. 2436 02:03:42,920 --> 02:03:46,720 SO WE SHOULD BE DOING THIS IN A 2437 02:03:46,720 --> 02:03:51,440 VERY ITERATIVE WAY. 2438 02:03:51,440 --> 02:03:52,880 THESE SUGGESTIONS ARE ULTIMATELY 2439 02:03:52,880 --> 02:03:54,240 ALIGNED WITH THE EXISTING 2440 02:03:54,240 --> 02:03:55,520 GUIDELINES THAT I TALKED ABOUT 2441 02:03:55,520 --> 02:03:56,920 INITIALLY, BUT ALSO TAKE INTO 2442 02:03:56,920 --> 02:03:59,040 ACCOUNT NUANCES THAT ARE 2443 02:03:59,040 --> 02:04:00,560 PARTICULARLY ASSOCIATED WITH THE 2444 02:04:00,560 --> 02:04:03,760 UNIQUE CHALLENGE OF SUPPORTING 2445 02:04:03,760 --> 02:04:04,920 IMPLANTABLE SYSTEMS FOR TREATING 2446 02:04:04,920 --> 02:04:06,320 CHRONIC DEBILITATING DISORDERS 2447 02:04:06,320 --> 02:04:07,800 LIKE THE ONES WE DO. 2448 02:04:07,800 --> 02:04:10,120 WE NEED TO WORK COLLABORATIVELY 2449 02:04:10,120 --> 02:04:10,920 BETWEEN DIFFERENT STAKEHOLDER 2450 02:04:10,920 --> 02:04:14,080 GROUPS AND CONTINUE TO RECENTER 2451 02:04:14,080 --> 02:04:15,160 AND CONSIDER PATIENT'S BEST 2452 02:04:15,160 --> 02:04:17,680 INTERESTS AS WE THINK ABOUT 2453 02:04:17,680 --> 02:04:20,400 PROBLEM SOLVING FOR TRIALS THAT 2454 02:04:20,400 --> 02:04:22,200 WE ARE GOING TO BE PLANNING FOR 2455 02:04:22,200 --> 02:04:23,840 IN THE FUTURE. 2456 02:04:23,840 --> 02:04:28,320 WITH THAT, I WOULD LIKE TO END 2457 02:04:28,320 --> 02:04:30,760 HERE AND I CAN TAKE QUESTIONS. 2458 02:04:30,760 --> 02:04:36,240 THANK YOU. 2459 02:04:36,240 --> 02:04:38,280 I SEE USUAL HAND UP. 2460 02:04:38,280 --> 02:04:39,320 >> THANK YOU SO MUCH. 2461 02:04:39,320 --> 02:04:40,840 THAT WAS WONDERFUL. 2462 02:04:40,840 --> 02:04:43,320 I WAS HOPING YOU COULD SPEAK TO 2463 02:04:43,320 --> 02:04:46,480 A LITTLE BIT WHAT THE CURRENT 2464 02:04:46,480 --> 02:04:53,000 PRACTICES ARE IN MAYBE BROADLY 2465 02:04:53,000 --> 02:05:01,920 FROM DEVICE MANUFACTURERS, 2466 02:05:01,920 --> 02:05:03,640 POST-TRIAL CARE, COULD YOU SPEAK 2467 02:05:03,640 --> 02:05:05,440 TO THAT FOR A MOMENT. 2468 02:05:05,440 --> 02:05:06,720 >> THERE ISN'T ONE SPECIFIC 2469 02:05:06,720 --> 02:05:08,880 ANSWER TO THAT QUESTION, RIGHT. 2470 02:05:08,880 --> 02:05:16,920 SO I THINK WITH TRIALS THAT WE 2471 02:05:16,920 --> 02:05:20,920 HAVE CONDUCTED WHERE PATIENTS 2472 02:05:20,920 --> 02:05:23,640 NEEDED POST-TRIAL ACCESS -- AS I 2473 02:05:23,640 --> 02:05:24,880 SAID IT'S A COMPLEX NUANCE TOPIC 2474 02:05:24,880 --> 02:05:26,560 AND THERE ARE A LOT OF FACTORS 2475 02:05:26,560 --> 02:05:27,600 THAT GO INTO DECISION-MAKING 2476 02:05:27,600 --> 02:05:31,400 WHAT WE SUPPORT AND HOW WE 2477 02:05:31,400 --> 02:05:36,160 SUPPORT THAT. 2478 02:05:36,160 --> 02:05:38,560 RIGHT NOW IT'S SITUATION BASED 2479 02:05:38,560 --> 02:05:39,760 WHAT THE PATIENT NEEDS AND 2480 02:05:39,760 --> 02:05:43,440 THAT'S WHAT WE TAKE INTO ACT IN 2481 02:05:43,440 --> 02:05:47,040 MAKING THE DECISION HOW DO WE 2482 02:05:47,040 --> 02:05:48,000 SUPPORT THE PATIENT. 2483 02:05:48,000 --> 02:05:49,440 THAT'S WHERE IT COMES FROM, WE 2484 02:05:49,440 --> 02:05:50,600 KNOW FROM OUR EXPERIENCE IT'S 2485 02:05:50,600 --> 02:05:52,240 NOT GOING TO BE A 2486 02:05:52,240 --> 02:05:52,640 ONE-SIZE-FITS-ALL. 2487 02:05:52,640 --> 02:05:54,360 IT'S KIND OF HARD TO SAY THERE'S 2488 02:05:54,360 --> 02:05:55,680 A STANDARD PRACTICE BECAUSE WE 2489 02:05:55,680 --> 02:05:57,160 KNOW THAT A STANDARD PRACTICE 2490 02:05:57,160 --> 02:05:58,880 MAY NOT BE BENEFICIAL TO 2491 02:05:58,880 --> 02:05:59,880 EVERYONE THAT'S INVOLVED. 2492 02:05:59,880 --> 02:06:01,080 SO I THINK WE SHOULD COME UP 2493 02:06:01,080 --> 02:06:02,560 WITH A STANDARD PRACTICE AND 2494 02:06:02,560 --> 02:06:04,320 MAYBE THAT STANDARD PRACTICE 2495 02:06:04,320 --> 02:06:05,920 NEEDS TO BE DEFINED AHEAD OF 2496 02:06:05,920 --> 02:06:08,040 TIME SO THAT EVERYONE, SO 2497 02:06:08,040 --> 02:06:08,720 THERE'S ENOUGH TRANSPARENCY 2498 02:06:08,720 --> 02:06:10,600 BUILT IN EVEN FOR THE PATIENTS 2499 02:06:10,600 --> 02:06:12,240 THAT ARE PARTICIPATING IN THESE 2500 02:06:12,240 --> 02:06:14,680 TRIALS SO THEY KNOW KIND OF WHAT 2501 02:06:14,680 --> 02:06:17,640 TO EXPECT IF THINGS DON'T GO AS 2502 02:06:17,640 --> 02:06:19,400 WE ALL HOPED THEY WOULD GO. 2503 02:06:19,400 --> 02:06:20,880 BECAUSE I THINK WE ALL TEND TO 2504 02:06:20,880 --> 02:06:23,520 BE VERY OPTIMISTIC BY NATURE 2505 02:06:23,520 --> 02:06:24,920 WHICH IS GOOD. 2506 02:06:24,920 --> 02:06:27,480 BUT YOU SHOULD ALSO KIND OF PLAN 2507 02:06:27,480 --> 02:06:31,880 FOR THE REALISTIC SCENARIOS. 2508 02:06:31,880 --> 02:06:34,560 >> THAT'S GREAT. 2509 02:06:34,560 --> 02:06:35,800 MAYBE WE'LL KEEP MOVING. 2510 02:06:35,800 --> 02:06:38,960 THERE'S GOING TO BE I THINK A 2511 02:06:38,960 --> 02:06:42,520 BUNCH OF QUESTIONS THAT CAN 2512 02:06:42,520 --> 02:06:45,520 LIGHT -- FURTHER FLESH OUT HOW 2513 02:06:45,520 --> 02:06:46,440 THAT PARTICIPATION MIGHT LOOK 2514 02:06:46,440 --> 02:06:46,760 LIKE. 2515 02:06:46,760 --> 02:06:47,680 I THINK IT WOULD BE GREAT TO 2516 02:06:47,680 --> 02:06:49,320 COME BACK TO THAT. 2517 02:06:49,320 --> 02:06:50,280 >> THAT'S GREAT. 2518 02:06:50,280 --> 02:06:51,840 THANKS AMIR. 2519 02:06:51,840 --> 02:06:55,440 >> LET ME GO AHEAD AND 2520 02:06:55,440 --> 02:06:56,920 INTRODUCE OUR SECOND SPEAKER OF 2521 02:06:56,920 --> 02:06:59,160 THE SESSION. 2522 02:06:59,160 --> 02:07:02,760 PLEASURE TO INTRODUCE DR. MARTY 2523 02:07:02,760 --> 02:07:06,040 MORRELL FROM STANFORD 2524 02:07:06,040 --> 02:07:06,360 UNIVERSITY. 2525 02:07:06,360 --> 02:07:07,280 HAS ACTIVELY BEEN INVOLVED IN 2526 02:07:07,280 --> 02:07:08,480 HELPING TO BRING NEW MEDICAL AND 2527 02:07:08,480 --> 02:07:09,680 DEVICE THERAPIES TO PATIENTS 2528 02:07:09,680 --> 02:07:11,160 WITH EPILEPSY. 2529 02:07:11,160 --> 02:07:13,680 SINCE 2004, SHE SERVED AS THE 2530 02:07:13,680 --> 02:07:15,040 CHIEF MEDICAL OFFICER AT 2531 02:07:15,040 --> 02:07:16,280 NEUROCASE A COMPANY THAT 2532 02:07:16,280 --> 02:07:19,480 DEVELOPED A RESPONSIVE 2533 02:07:19,480 --> 02:07:20,880 NEUROSTIMULATE TER FOR TREATMENT 2534 02:07:20,880 --> 02:07:25,920 OF UNCONTROLLABLE PARTIAL 2535 02:07:25,920 --> 02:07:26,720 SEIZURES. 2536 02:07:26,720 --> 02:07:28,720 PAST PRESIDENT AND PRINCIPAL 2537 02:07:28,720 --> 02:07:31,160 INVESTIGATOR OF A GRANT FOR 2538 02:07:31,160 --> 02:07:35,160 RESPONSE FOR LINUX GASTO 2539 02:07:35,160 --> 02:07:37,920 SYNDROME, RARE FORM OF EPILEPSY. 2540 02:07:37,920 --> 02:07:38,760 THANK YOU. 2541 02:07:38,760 --> 02:07:41,520 >> THANK YOU SO MUCH, SAMIR. 2542 02:07:41,520 --> 02:07:44,880 AND I'M SO PLEASED BECAUSE YOU 2543 02:07:44,880 --> 02:07:46,280 NEVER WANT TO COME AND SPEAK 2544 02:07:46,280 --> 02:07:47,440 WHEN YOU'RE SAYING THE SAME 2545 02:07:47,440 --> 02:07:48,880 THING AS EVERYBODY ELSE, BUT I 2546 02:07:48,880 --> 02:07:50,680 THINK THERE'S GOING TO BE A FAIR 2547 02:07:50,680 --> 02:07:53,480 AMOUNT OF THAT, WHICH I BELIEVE 2548 02:07:53,480 --> 02:07:55,440 IS GOOD IN THIS CONTEXT. 2549 02:07:55,440 --> 02:07:58,200 SO JUST TO TELL YOU, I HAVE SOME 2550 02:07:58,200 --> 02:08:00,040 POTENTIAL CONFLICTS WHICH I'LL 2551 02:08:00,040 --> 02:08:03,680 MAKE VERY APPARENT. 2552 02:08:03,680 --> 02:08:06,160 I'M CHIEF MEDICAL OFFICER NEURO, 2553 02:08:06,160 --> 02:08:08,560 AS SAMIR SAID AND I'M ALSO AT 2554 02:08:08,560 --> 02:08:12,840 STANFORD AND I'M BEING FUNDED 2555 02:08:12,840 --> 02:08:13,960 FORTUNATELY BY NIH. 2556 02:08:13,960 --> 02:08:15,400 THESE ARE MY OWN VIEWS. 2557 02:08:15,400 --> 02:08:16,600 THEY DON'T REPRESENT ANYBODY 2558 02:08:16,600 --> 02:08:16,840 ELSE'S. 2559 02:08:16,840 --> 02:08:18,920 BUT LET ME GIVE YOU MY 2560 02:08:18,920 --> 02:08:19,440 PERSPECTIVE. 2561 02:08:19,440 --> 02:08:22,760 I AM FIRST AND FOREMOST A 2562 02:08:22,760 --> 02:08:23,440 PHYSICIAN. 2563 02:08:23,440 --> 02:08:25,640 I'M A NEUROLOGIST WHO IS SPECIAL 2564 02:08:25,640 --> 02:08:27,960 TRAINED IN EPILEPSY. 2565 02:08:27,960 --> 02:08:30,680 AND SPEND THE MAJORITY OF MY 2566 02:08:30,680 --> 02:08:34,480 CAREER IN ACADEMICS AS A 2567 02:08:34,480 --> 02:08:36,920 CLINICIAN TEACHER AND 2568 02:08:36,920 --> 02:08:38,960 TRANSLATIONAL RESEARCH PERSON. 2569 02:08:38,960 --> 02:08:43,400 I THEN, AS PART OF ALL OF THAT 2570 02:08:43,400 --> 02:08:44,520 TRANSITIONED INTO INDUSTRY WITH 2571 02:08:44,520 --> 02:08:46,400 A STARTUP DEVELOPING A NEW 2572 02:08:46,400 --> 02:08:47,520 PRODUCT FOR THE DISORDER THAT I 2573 02:08:47,520 --> 02:08:50,200 WAS TREATING IN MY PATIENTS 2574 02:08:50,200 --> 02:08:51,400 EPILEPSY. 2575 02:08:51,400 --> 02:08:52,760 I CONSIDER MYSELF A PATIENT 2576 02:08:52,760 --> 02:08:54,680 ADVOCATE. 2577 02:08:54,680 --> 02:08:56,880 I'VE BEEN VERY INVOLVED WITH 2578 02:08:56,880 --> 02:08:59,120 PATIENT ADVOCACY ORGANIZATIONS 2579 02:08:59,120 --> 02:09:00,720 AND I AM ALSO NOW IN THE SECOND 2580 02:09:00,720 --> 02:09:04,880 PART OF MY CAREER VERY SENSITIVE 2581 02:09:04,880 --> 02:09:07,400 TO WHAT IT TAKES TO BRING 2582 02:09:07,400 --> 02:09:08,680 SOMETHING ENTIRELY NEW TO 2583 02:09:08,680 --> 02:09:15,560 PATIENTS AND HOW HARD THAT IS. 2584 02:09:15,560 --> 02:09:16,240 SO I MAY ACTUALLY EMPHASIZE A 2585 02:09:16,240 --> 02:09:17,640 LITTLE BIT MORE THE SMALL 2586 02:09:17,640 --> 02:09:20,200 COMPANY PERSPECTIVE WHICH MAY 2587 02:09:20,200 --> 02:09:21,480 NOT BE AS FAMILIAR WITH 2588 02:09:21,480 --> 02:09:21,760 EVERYONE. 2589 02:09:21,760 --> 02:09:24,200 BUT WHAT DO WE HAVE HERE? 2590 02:09:24,200 --> 02:09:26,240 I WAS READING THE PREWORK THAT 2591 02:09:26,240 --> 02:09:28,520 WAS DONE, A LOT OF STUFF ABOUT 2592 02:09:28,520 --> 02:09:31,640 SHARED BURDEN, BUT IT'S ALSO A 2593 02:09:31,640 --> 02:09:33,920 SHARED OPPORTUNITY. 2594 02:09:33,920 --> 02:09:36,880 AND THE OPPORTUNITY FOR THE 2595 02:09:36,880 --> 02:09:38,800 PATIENT AND HER LOVED ONES IS 2596 02:09:38,800 --> 02:09:40,240 THAT THE TREATMENT WILL BRING 2597 02:09:40,240 --> 02:09:41,560 HEALTH AND BETTER QUALITY OF 2598 02:09:41,560 --> 02:09:42,640 LIFE. 2599 02:09:42,640 --> 02:09:44,120 AND FOR THE ACADEMIC RESEARCH 2600 02:09:44,120 --> 02:09:47,000 INSTITUTE, THAT'S A BUSINESS, AS 2601 02:09:47,000 --> 02:09:48,920 MUCH AS ANYTHING ELSE, BUT OF 2602 02:09:48,920 --> 02:09:52,120 COURSE IT'S MISSION DRIVEN 2603 02:09:52,120 --> 02:09:52,920 BUSINESS. 2604 02:09:52,920 --> 02:09:54,600 FOR PHYSICIANS, ALTHOUGH 2605 02:09:54,600 --> 02:09:56,400 OBVIOUSLY PHYSICIANS MAKE MONEY, 2606 02:09:56,400 --> 02:09:59,480 THEY HAVE TO, I THINK MOST 2607 02:09:59,480 --> 02:10:03,840 PEOPLE GO INTO HEALING 2608 02:10:03,840 --> 02:10:04,880 PROFESSIONS BECAUSE THEY'RE 2609 02:10:04,880 --> 02:10:07,080 MOTIVATED TO HELP REDUCE 2610 02:10:07,080 --> 02:10:07,880 SUFFERING AND SOCIETY RECOGNIZES 2611 02:10:07,880 --> 02:10:10,280 THAT IT'S NOT JUST THE MONEY, 2612 02:10:10,280 --> 02:10:11,800 IT'S THE COST OF MISSED 2613 02:10:11,800 --> 02:10:12,360 OPPORTUNITIES. 2614 02:10:12,360 --> 02:10:15,880 IT'S THE LIFE THAT IS NOT LIVED. 2615 02:10:15,880 --> 02:10:18,720 AND FOR INDUSTRY, IN ORDER TO 2616 02:10:18,720 --> 02:10:20,640 SURVIVE MUST BE A COMMERCIALLY 2617 02:10:20,640 --> 02:10:24,920 VIABLE PRODUCT BUT I WOULD SAY 2618 02:10:24,920 --> 02:10:28,280 PEOPLE CAN DO VIDEO GAME 2619 02:10:28,280 --> 02:10:29,800 SOFTWARE OR HEALTHCARE 2620 02:10:29,800 --> 02:10:30,880 TECHNOLOGY THERE'S THAT 2621 02:10:30,880 --> 02:10:31,200 MOTIVATION. 2622 02:10:31,200 --> 02:10:32,160 FOR INSURERS, I THINK THE 2623 02:10:32,160 --> 02:10:33,840 MOTIVATION IS REALLY TO MAINTAIN 2624 02:10:33,840 --> 02:10:36,280 THE HEALTH OF THIS SUBSCRIBER 2625 02:10:36,280 --> 02:10:38,400 AND THAT OF COURSE REDUCES 2626 02:10:38,400 --> 02:10:41,120 MEDICAL COSTS. 2627 02:10:41,120 --> 02:10:42,440 THERE ARE FINANCIAL INCENTIVES 2628 02:10:42,440 --> 02:10:46,600 AND ALSO A MISSION AND ALTRUISM 2629 02:10:46,600 --> 02:10:48,120 AND I THINK THE MOTIVATION TO 2630 02:10:48,120 --> 02:10:48,920 BENEFIT INDIVIDUALS IN SOCIETY 2631 02:10:48,920 --> 02:10:55,400 IS SOMETHING THAT IS UNIFYING. 2632 02:10:55,400 --> 02:10:59,920 WE HAVE A SHARED RESPONSIBILITY. 2633 02:10:59,920 --> 02:11:02,080 NOW I WANT TO SHARE ABOUT THE 2634 02:11:02,080 --> 02:11:03,720 COMPANY I'M WORKING WITH TO SET 2635 02:11:03,720 --> 02:11:04,200 IS CONTEXT. 2636 02:11:04,200 --> 02:11:07,440 THIS IS A COMPANY THAT WAS 2637 02:11:07,440 --> 02:11:14,240 FOUNDED IN 1997 THE CONCEPT AND 2638 02:11:14,240 --> 02:11:19,320 PROVIDE THEM TO AN HE SOUGHTIC 2639 02:11:19,320 --> 02:11:21,160 DISORDER EPILEPSY AND THE 2640 02:11:21,160 --> 02:11:22,480 COMPANY SPENT A YEAR DOING 2641 02:11:22,480 --> 02:11:24,920 DEVELOPMENT AND PROOF OF CONCEPT 2642 02:11:24,920 --> 02:11:28,920 SO BY 2002 THERE WAS AN 2643 02:11:28,920 --> 02:11:32,880 IMPLANTABLE DEVICE THAT COULD BE 2644 02:11:32,880 --> 02:11:36,880 TESTED IN 2004 THE TRIALS BEGAN 2645 02:11:36,880 --> 02:11:41,000 OF FIRST ENDED UP 256 PEOPLE 2646 02:11:41,000 --> 02:11:43,000 IMPLANTED. 2647 02:11:43,000 --> 02:11:45,840 THESE INDIVIDUALS WERE FOLLOWED 2648 02:11:45,840 --> 02:11:46,840 FOR NINE YEARS. 2649 02:11:46,840 --> 02:11:50,160 AND IN 2010 AN APPLICATION WAS 2650 02:11:50,160 --> 02:11:52,920 APPLIED FOR AN APPROVAL 2651 02:11:52,920 --> 02:11:55,920 PREMARKET APPROVAL APPLICATION 2652 02:11:55,920 --> 02:11:58,480 FOR FDA'S CLASS 3 IMPLANTABLE 2653 02:11:58,480 --> 02:11:58,920 DEVICE. 2654 02:11:58,920 --> 02:12:00,240 FOR HUMOR, 2010 FDA WANTED 2655 02:12:00,240 --> 02:12:01,240 EVERYTHING IN PAPER COPIES AND 2656 02:12:01,240 --> 02:12:02,240 THREE COPIES. 2657 02:12:02,240 --> 02:12:05,480 SO THIS IS WHAT IT LOOKED LIKE, 2658 02:12:05,480 --> 02:12:07,440 AND THAT'S THAT. 2659 02:12:07,440 --> 02:12:08,880 AND OF COURSE IT BEING A NOVEL 2660 02:12:08,880 --> 02:12:11,920 DEVICE, THERE WAS AN ADVISORY 2661 02:12:11,920 --> 02:12:14,400 PANEL IN 2011 AND THEN DOING 2662 02:12:14,400 --> 02:12:16,160 THIS THE RIGHT WAY THEN FINALLY 2663 02:12:16,160 --> 02:12:19,360 IN 2003, NOVEMBER, THE END OF 2664 02:12:19,360 --> 02:12:21,680 NOVEMBER, FDA PROVIDED APPROVAL 2665 02:12:21,680 --> 02:12:23,400 FOR PARTIAL SEIZURES. 2666 02:12:23,400 --> 02:12:27,120 AND THEN IN 2015, WE WERE ABLE 2667 02:12:27,120 --> 02:12:29,520 TO HAVE OUR TWO-YEAR PATIENT 2668 02:12:29,520 --> 02:12:30,120 CELEBRATION WHICH WAS VERY 2669 02:12:30,120 --> 02:12:30,560 MOVING. 2670 02:12:30,560 --> 02:12:34,200 NOW, WHAT DOES THIS MEAN WITH 2671 02:12:34,200 --> 02:12:35,720 16 YEARS? 2672 02:12:35,720 --> 02:12:37,200 AND OVER $350 MILLION IN A 2673 02:12:37,200 --> 02:12:41,040 COMPANY THAT EXISTED ONLY FOR 2674 02:12:41,040 --> 02:12:41,240 THIS. 2675 02:12:41,240 --> 02:12:44,600 AND SO THERE WERE MANY NEAR 2676 02:12:44,600 --> 02:12:45,840 DEATHS ALONG THE WAY FOR A 2677 02:12:45,840 --> 02:12:47,400 NUMBER OF REASONS, EVEN THOUGH 2678 02:12:47,400 --> 02:12:50,200 THE RESULTS WERE VERY STRONG. 2679 02:12:50,200 --> 02:12:52,480 THERE WAS JUST A LONG TIME, A 2680 02:12:52,480 --> 02:12:54,600 LOT OF MONEY, A LOT OF RISK. 2681 02:12:54,600 --> 02:12:58,520 MY OTHER STORY IS TO TALK ABOUT 2682 02:12:58,520 --> 02:13:00,160 THE APPLICATION OF THE 2683 02:13:00,160 --> 02:13:03,320 TECHNOLOGY TO A TERRIBLE 2684 02:13:03,320 --> 02:13:03,600 DISORDER. 2685 02:13:03,600 --> 02:13:07,440 AND THIS IS AN INVESTMENT THAT 2686 02:13:07,440 --> 02:13:08,920 NIH IS MAKING. 2687 02:13:08,920 --> 02:13:13,600 SUPPLYING APPLYING THIS 2688 02:13:13,600 --> 02:13:17,600 TECHNOLOGY AND APPLYING IT TO A 2689 02:13:17,600 --> 02:13:24,880 EPILEPSY CALLED LINUX GASTO, 2690 02:13:24,880 --> 02:13:27,280 INJURY AND HIGH RISK OF DEATH 2691 02:13:27,280 --> 02:13:29,840 AND THERE AREN'T ANY OTHER 2692 02:13:29,840 --> 02:13:30,600 OPTIONS. 2693 02:13:30,600 --> 02:13:32,680 THIS IS NOT ONLY TERRIFICALLY 2694 02:13:32,680 --> 02:13:34,920 IMPACTFUL TO PATIENT BUT ALSO 2695 02:13:34,920 --> 02:13:35,240 CAREGIVERS. 2696 02:13:35,240 --> 02:13:37,440 SO OTHER SOLUTIONS ARE NEEDED. 2697 02:13:37,440 --> 02:13:39,400 THIS IS A RARE DISEASE. 2698 02:13:39,400 --> 02:13:41,760 IT'S AN ORPHAN INDICATION. 2699 02:13:41,760 --> 02:13:43,440 THERE IS NO COMMERCIAL 2700 02:13:43,440 --> 02:13:44,760 MOTIVATION TO DELIVER A THERAPY 2701 02:13:44,760 --> 02:13:48,280 FOR THIS PATIENT POPULATION, BUT 2702 02:13:48,280 --> 02:13:50,080 THERE SURE IS THE CLINICAL 2703 02:13:50,080 --> 02:13:52,920 MOTIVATION, THE ALTRUISM, THE 2704 02:13:52,920 --> 02:13:54,600 WANT TO HELP EASE SUFFERING. 2705 02:13:54,600 --> 02:13:58,200 SO A GRANT WAS SUBMITTED WITH 2706 02:13:58,200 --> 02:14:01,120 SIX ACADEMIC MEDICAL CENTERS TO 2707 02:14:01,120 --> 02:14:02,680 APPLY SOME OF THE DEVICE OF THIS 2708 02:14:02,680 --> 02:14:04,880 DEVICE, AND IT WAS TERRIFIC. 2709 02:14:04,880 --> 02:14:06,920 IN MARCH 2020, NIH INDICATED 2710 02:14:06,920 --> 02:14:10,840 THAT FUNDING WAS LIKELY BUT DID 2711 02:14:10,840 --> 02:14:13,560 SAY THAT PROBABLY IT WOULD 2712 02:14:13,560 --> 02:14:16,280 REQUIRE AN ACCEPTABLE PLAN TO 2713 02:14:16,280 --> 02:14:19,120 PROVIDE POST STUDY CARE. 2714 02:14:19,120 --> 02:14:22,760 AND SO OUR PROJECT OFFICERS, 2715 02:14:22,760 --> 02:14:24,880 FABULOUS, SAID, SEE WHAT YOU CAN 2716 02:14:24,880 --> 02:14:25,440 DO. 2717 02:14:25,440 --> 02:14:28,720 SO WE EXPLORED OPTIONS. 2718 02:14:28,720 --> 02:14:30,160 WE COULD NOT GUARANTEE THAT 2719 02:14:30,160 --> 02:14:33,880 AFTER THIS TRIAL WE WOULD BE 2720 02:14:33,880 --> 02:14:35,760 FINANCIALLY ABLE TO PROVIDE CARE 2721 02:14:35,760 --> 02:14:36,920 BECAUSE EVEN AT THAT POINT YOU 2722 02:14:36,920 --> 02:14:39,280 DON'T EVEN KNOW IF COMPANY IS 2723 02:14:39,280 --> 02:14:40,880 GOING TO BE VIABLE. 2724 02:14:40,880 --> 02:14:42,000 NEUROPATIENTS IS OKAY, BUT FOR 2725 02:14:42,000 --> 02:14:43,920 YOUNG COMPANIES, WHAT IF IT 2726 02:14:43,920 --> 02:14:45,240 DOESN'T EXIST ANY LONGER? 2727 02:14:45,240 --> 02:14:47,480 AND IN GOING TO EACH OF THE 2728 02:14:47,480 --> 02:14:49,440 ACADEMIC INSTITUTIONS AND 2729 02:14:49,440 --> 02:14:50,960 HOSPITALS, THEY WERE NOT WILLING 2730 02:14:50,960 --> 02:14:56,080 TO COMMIT TO ANY FUNDS IN THE 2731 02:14:56,080 --> 02:15:00,080 FUTURE AND WE REACH OUT TO 2732 02:15:00,080 --> 02:15:01,440 ENSURER, EVEN OUTSIDE THE UNITED 2733 02:15:01,440 --> 02:15:04,040 STATES, THE ONES THAT INSURE 2734 02:15:04,040 --> 02:15:05,840 JENNIFER ANISTON'S HAIR AND 2735 02:15:05,840 --> 02:15:06,760 EARTHQUAKES, THESE RARE EVENTS, 2736 02:15:06,760 --> 02:15:08,880 TO SEE IF THEY WOULD BE WILLING 2737 02:15:08,880 --> 02:15:12,080 TO CREATE A POLICY FOR POST 2738 02:15:12,080 --> 02:15:14,000 STUDY CARE THAT NEUROPACE COULD 2739 02:15:14,000 --> 02:15:15,240 PAY FOR. 2740 02:15:15,240 --> 02:15:16,760 BUT THERE'S NO PRECEDENT FOR 2741 02:15:16,760 --> 02:15:17,920 THAT. 2742 02:15:17,920 --> 02:15:20,920 AND IT WAS NOT POSSIBLE TO GET A 2743 02:15:20,920 --> 02:15:23,920 SUPPLEMENT TO THE NIH GRANT. 2744 02:15:23,920 --> 02:15:26,080 NIH TO PROVIDE FOR THIS AND WE 2745 02:15:26,080 --> 02:15:28,360 COULD GO TO CMS BUT THEY HAVE NO 2746 02:15:28,360 --> 02:15:31,280 MECHANISM FOR ESTABLISHING POST 2747 02:15:31,280 --> 02:15:32,560 STUDY CARE EITHER. 2748 02:15:32,560 --> 02:15:34,000 SO I FELT LIKE THERE WAS ALL OF 2749 02:15:34,000 --> 02:15:35,360 THIS GOING ON. 2750 02:15:35,360 --> 02:15:37,440 AND WE ALL WANTED THE SAME 2751 02:15:37,440 --> 02:15:37,720 THING. 2752 02:15:37,720 --> 02:15:39,360 SO THAT'S NOT GOING TO WORK. 2753 02:15:39,360 --> 02:15:41,560 SO WE HAVE TO FIGURE OUT HOW TO 2754 02:15:41,560 --> 02:15:42,400 DO THIS. 2755 02:15:42,400 --> 02:15:44,040 AND WHAT HAPPENED? 2756 02:15:44,040 --> 02:15:47,320 WELL, IT WAS THE YEAR OF GETTING 2757 02:15:47,320 --> 02:15:49,480 TO SOMEPLACE OF AGREEMENT. 2758 02:15:49,480 --> 02:15:50,840 AND EVERYONE WAS SATISFIED THAT 2759 02:15:50,840 --> 02:15:53,080 THESE INDIVIDUALS HAVE TERRIBLE 2760 02:15:53,080 --> 02:15:54,760 EPILEPSY, THEY WILL BE GETTING 2761 02:15:54,760 --> 02:15:56,920 ROUTINE EPILEPSY CARE SO REGULAR 2762 02:15:56,920 --> 02:15:59,680 ACCESS TO PHYSICIANS WILL BE 2763 02:15:59,680 --> 02:16:00,080 COVERED. 2764 02:16:00,080 --> 02:16:01,720 NEUROPACE COMMITTED TO DONATING 2765 02:16:01,720 --> 02:16:03,200 THE DEVICE AND PROVIDING SUPPORT 2766 02:16:03,200 --> 02:16:04,000 FOR THE DEVICE. 2767 02:16:04,000 --> 02:16:06,440 IT'S NOT COVERED BY THE INSURER. 2768 02:16:06,440 --> 02:16:07,800 AND THE PARTICIPATING PHYSICIANS 2769 02:16:07,800 --> 02:16:10,120 SAID THEY WOULD PROVIDE 2770 02:16:10,120 --> 02:16:11,840 PROGRAMMING FOR THE CHARGE FOR 2771 02:16:11,840 --> 02:16:12,880 UNINSURED PATIENTS. 2772 02:16:12,880 --> 02:16:14,640 HOWEVER, THE INSTITUTIONS AND 2773 02:16:14,640 --> 02:16:17,480 THE HOSPITALS WERE NOT WILLING 2774 02:16:17,480 --> 02:16:18,040 TO DO THAT. 2775 02:16:18,040 --> 02:16:19,640 BUT THOUGH DID SAY AND PUT IN 2776 02:16:19,640 --> 02:16:22,920 WRITING THEY WOULD AGREE TO WORK 2777 02:16:22,920 --> 02:16:26,920 VERY HARD TO GET THIS. 2778 02:16:26,920 --> 02:16:31,320 AND THEN FINALLY THE PATIENT AND 2779 02:16:31,320 --> 02:16:33,400 IN THIS CASE MOSTLY THEIR FAMILY 2780 02:16:33,400 --> 02:16:35,240 MEMBERS DO HAVE IN THE CONSENT 2781 02:16:35,240 --> 02:16:37,680 AND ASCENT, THAT IF ALL THE 2782 02:16:37,680 --> 02:16:41,200 INSURANCE OPTIONS ARE EXHAUSTED 2783 02:16:41,200 --> 02:16:43,320 THEN THERE MAY BE INDIVIDUAL 2784 02:16:43,320 --> 02:16:46,560 RESPONSIBILITY FOR COSTS. 2785 02:16:46,560 --> 02:16:49,480 SO IN THIS CASE MOST EVERYBODY 2786 02:16:49,480 --> 02:16:50,960 HAS A PIECE OF THE SOLUTION. 2787 02:16:50,960 --> 02:16:54,120 BUT IT TOOK A LONG TIME. 2788 02:16:54,120 --> 02:16:56,280 SO IT WAS WELL OVER A YEAR FROM 2789 02:16:56,280 --> 02:16:57,720 THE TIME THAT WE HEARD THAT IT 2790 02:16:57,720 --> 02:16:58,720 WAS LIKELY THAT THE GRANT WOULD 2791 02:16:58,720 --> 02:17:04,520 BE FUNDED UNTIL WE RECEIVED OUR 2792 02:17:04,520 --> 02:17:04,920 YOU 2793 02:17:04,920 --> 02:17:06,360 YOUNGEST SINGLE AWARD. 2794 02:17:06,360 --> 02:17:08,960 IT WAS NOT FOR THE LACK OF THE 2795 02:17:08,960 --> 02:17:10,240 NIH TEAM HELPING AND TRYING THEY 2796 02:17:10,240 --> 02:17:10,880 ABSOLUTELY DID. 2797 02:17:10,880 --> 02:17:12,280 BUT IN THE MEANTIME THESE ARE 2798 02:17:12,280 --> 02:17:13,640 PEOPLE WITH NO TREATMENT WHO 2799 02:17:13,640 --> 02:17:16,680 WERE DYING FROM THEIR DISEASE. 2800 02:17:16,680 --> 02:17:18,800 SO IT'S HAVING THINGS TOGETHER 2801 02:17:18,800 --> 02:17:20,880 AHEAD OF TIME IN SOME 2802 02:17:20,880 --> 02:17:21,880 UNDERSTANDING. 2803 02:17:21,880 --> 02:17:25,080 TIME IS REALLY OF THE ESSENCE. 2804 02:17:25,080 --> 02:17:27,840 SO WHO SHOULD PAY FOR POST STUDY 2805 02:17:27,840 --> 02:17:35,440 CARE IF THE DEVICE IS NOT 2806 02:17:35,440 --> 02:17:35,720 APPROVED? 2807 02:17:35,720 --> 02:17:36,960 OR THE COMPANY DOESN'T EXIST. 2808 02:17:36,960 --> 02:17:38,360 WE JUST HEARD A WONDERFUL 2809 02:17:38,360 --> 02:17:38,840 PRESENTATION. 2810 02:17:38,840 --> 02:17:40,600 THAT'S ABBOTT. 2811 02:17:40,600 --> 02:17:42,200 THEY'RE NOT GOING TO SEIZE TO 2812 02:17:42,200 --> 02:17:43,960 EXIST BUT A COMPANY LIKE 2813 02:17:43,960 --> 02:17:45,280 NEUROPACE CERTAINLY COULD. 2814 02:17:45,280 --> 02:17:47,480 SO IF IT'S A PROFITABLE COMPANY 2815 02:17:47,480 --> 02:17:49,520 THEN YOU CAN EXPECT THE COMPANY 2816 02:17:49,520 --> 02:17:52,640 TO OFFSET I BELIEVE FROM SOME 2817 02:17:52,640 --> 02:17:53,560 EXTENT TO OTHER REVENUES. 2818 02:17:53,560 --> 02:17:56,080 IF IT'S NONPROFIT TABLE 2819 02:17:56,080 --> 02:17:57,560 NONEXTENT COMPANY, THEN THE ONLY 2820 02:17:57,560 --> 02:17:59,160 WAY THE COMPANY CAN DO 2821 02:17:59,160 --> 02:18:00,920 SOMETHING, PUT IT ASIDE BOOK FOR 2822 02:18:00,920 --> 02:18:01,480 THE TRIAL. 2823 02:18:01,480 --> 02:18:04,720 AND SO I BELIEVE THAT IT IS 2824 02:18:04,720 --> 02:18:06,880 ACTUALLY REASONABLE WHEN SMALL 2825 02:18:06,880 --> 02:18:09,680 COMPANIES OR BIG COMPANIES ARE 2826 02:18:09,680 --> 02:18:11,320 DOING STUDIES TO PLAN AHEAD OF 2827 02:18:11,320 --> 02:18:14,880 TIME FOR MAKING SOME KIND OF 2828 02:18:14,880 --> 02:18:18,440 COMMITMENT FOR THE THINGS DON'T 2829 02:18:18,440 --> 02:18:19,280 GO WELL. 2830 02:18:19,280 --> 02:18:22,440 FOR MEDICAL INSURERS, IF THE 2831 02:18:22,440 --> 02:18:25,440 PATIENT BENEFITS, THEN I THINK 2832 02:18:25,440 --> 02:18:28,800 IT'S IN MY OPINION. 2833 02:18:28,800 --> 02:18:30,480 TO CONTINUE ON THE CARE. 2834 02:18:30,480 --> 02:18:31,480 IF THE PATIENT DOESN'T BENEFIT, 2835 02:18:31,480 --> 02:18:33,360 I WOULD HOPE THAT THE MEDICAL 2836 02:18:33,360 --> 02:18:35,400 CARE INSURER WOULD PARTICIPATE 2837 02:18:35,400 --> 02:18:38,560 IN COVERAGE FOR THE DEVICE 2838 02:18:38,560 --> 02:18:38,800 EXPLANT. 2839 02:18:38,800 --> 02:18:40,000 AND ACADEMIC INSTITUTIONS, THEY 2840 02:18:40,000 --> 02:18:41,440 BENEFIT FROM THE TRIAL. 2841 02:18:41,440 --> 02:18:42,560 THE ACADEMIC INSTITUTIONS ARE 2842 02:18:42,560 --> 02:18:44,720 OUR BIG INSTITUTIONS. 2843 02:18:44,720 --> 02:18:45,440 THEY ARE OUR ENTERPRISES. 2844 02:18:45,440 --> 02:18:47,240 THEY'RE COMPANIES. 2845 02:18:47,240 --> 02:18:48,400 THEY MAKE MONEY. 2846 02:18:48,400 --> 02:18:50,880 THAT THEY THEN PUT BACK INTO 2847 02:18:50,880 --> 02:18:51,600 YOUR MISSION. 2848 02:18:51,600 --> 02:18:53,800 BUT IF THEY ARE GOING TO MAKE 2849 02:18:53,800 --> 02:18:56,120 THAT COMMITMENT, THEN I BELIEVE 2850 02:18:56,120 --> 02:18:56,720 THERE'S SOME SHARED 2851 02:18:56,720 --> 02:18:58,440 RESPONSIBILITY FOR OUTCOMES. 2852 02:18:58,440 --> 02:19:00,880 AND THAT WOULD BE PERHAPS 2853 02:19:00,880 --> 02:19:02,440 PROVIDING PARTIAL CHARGES FOR 2854 02:19:02,440 --> 02:19:06,080 HOSPITAL PHYSICIAN SERVICES AND 2855 02:19:06,080 --> 02:19:10,120 THEN FOR PATIENTS I BELIEVE AS 2856 02:19:10,120 --> 02:19:11,840 WE HAVE IN OUR CONSENT FORM, 2857 02:19:11,840 --> 02:19:15,640 THERE'S BEEN A LOT OF DISCUSSION 2858 02:19:15,640 --> 02:19:18,680 ABOUT THAT THERE IS A PATIENT 2859 02:19:18,680 --> 02:19:23,400 AND FAMILY MEMBER PIECE OF THIS 2860 02:19:23,400 --> 02:19:24,600 AS HARD AS THAT IS SOMETIMES TO 2861 02:19:24,600 --> 02:19:24,800 THINK. 2862 02:19:24,800 --> 02:19:28,880 BUT CERTAINLY PEOPLE DO NEED TO 2863 02:19:28,880 --> 02:19:31,440 UNDERSTAND WHAT IS THE POTENTIAL 2864 02:19:31,440 --> 02:19:35,800 OUTCOME OF A NONAPPROVED DEVICE. 2865 02:19:35,800 --> 02:19:37,480 SO AND THEN GOVERNMENT FUNDERS. 2866 02:19:37,480 --> 02:19:40,440 AND WE'VE TALKED ABOUT NIH, BUT 2867 02:19:40,440 --> 02:19:41,320 FDA TOO. 2868 02:19:41,320 --> 02:19:45,440 FDA'S ORGANIZED TO PROTECT 2869 02:19:45,440 --> 02:19:46,760 PATIENT, PUBLIC SAFETY. 2870 02:19:46,760 --> 02:19:48,920 AND THEY DO ABSOLUTELY A 2871 02:19:48,920 --> 02:19:50,960 WONDERFUL JOB. 2872 02:19:50,960 --> 02:19:56,120 BUT THEY ALSO ARE DEVOTED TO THE 2873 02:19:56,120 --> 02:19:57,120 HEALTH OF THE PUBLIC. 2874 02:19:57,120 --> 02:19:58,600 AND PROBABLY RESEARCH IS PART OF 2875 02:19:58,600 --> 02:19:58,800 THAT. 2876 02:19:58,800 --> 02:20:01,440 AS IT IS FOR THE DEPARTMENT OF 2877 02:20:01,440 --> 02:20:05,840 DEFENSE, AS IT IS FOR MEDICARE 2878 02:20:05,840 --> 02:20:07,000 AND OTHERS. 2879 02:20:07,000 --> 02:20:08,080 WHAT WE NEED ARE CERTAINLY 2880 02:20:08,080 --> 02:20:11,040 ETHICAL PRINCIPLES GUIDING THIS, 2881 02:20:11,040 --> 02:20:16,040 AND THOSE HAVE GOT TO BE CORE. 2882 02:20:16,040 --> 02:20:21,560 BUT WE NEED PRACTICING PLAT MAT 2883 02:20:21,560 --> 02:20:24,880 TICK SOLUTIONS, I BELIEVE 2884 02:20:24,880 --> 02:20:30,760 EVERYONE IS INVOLVED IN THIS AND 2885 02:20:30,760 --> 02:20:34,360 ENJOYS THE GLORY. 2886 02:20:34,360 --> 02:20:36,000 THANKS, I'LL TURN IT OVER TO 2887 02:20:36,000 --> 02:20:36,640 MARTY 2888 02:20:36,640 --> 02:20:38,080 >> THANKS FOR THE OVERVIEW OF 2889 02:20:38,080 --> 02:20:38,600 THE SUBJECT. 2890 02:20:38,600 --> 02:20:41,640 WE HAVE TIME FOR ONE QUICK 2891 02:20:41,640 --> 02:20:51,520 QUESTION IF ANYBODY HAS ONE. 2892 02:20:51,520 --> 02:20:53,760 >> SARA. 2893 02:20:53,760 --> 02:20:58,720 >> INTERESTING, ALL THE FINGERS 2894 02:20:58,720 --> 02:20:59,720 ARE POINTING, THEY WANT EVERYONE 2895 02:20:59,720 --> 02:21:00,600 TO PAY. 2896 02:21:00,600 --> 02:21:02,400 AND YOU LIST THAT NEUROPACE 2897 02:21:02,400 --> 02:21:03,600 COVERS THE DEVICE IF IT'S NOT 2898 02:21:03,600 --> 02:21:05,400 COVERED BY INSURANCE. 2899 02:21:05,400 --> 02:21:07,440 AND THE UNIVERSITY HOSPITAL 2900 02:21:07,440 --> 02:21:10,360 DOING SOMETHING MAYBE NOT QUITE 2901 02:21:10,360 --> 02:21:13,040 DOING IT. 2902 02:21:13,040 --> 02:21:14,120 I'M WONDERING BECAUSE I DON'T 2903 02:21:14,120 --> 02:21:15,760 KNOW THE FIGURES, WHAT'S THE 2904 02:21:15,760 --> 02:21:17,360 PROPORTIONAL COST OF WHAT IT IS 2905 02:21:17,360 --> 02:21:19,040 TO PROVIDE THIS CARE, SO HOW 2906 02:21:19,040 --> 02:21:21,440 MUCH OF IT IS COVERED BY 2907 02:21:21,440 --> 02:21:22,440 NEUROPACE, HOW MUCH ARE THE 2908 02:21:22,440 --> 02:21:23,680 DEVICES RELATIVE TO THE CARE 2909 02:21:23,680 --> 02:21:26,880 THAT MIGHT BE NEEDED FOR YEARS 2910 02:21:26,880 --> 02:21:35,040 AND YEARS? 2911 02:21:35,040 --> 02:21:36,280 YOU KNOW THE COST OF SOMETHING 2912 02:21:36,280 --> 02:21:37,040 IS VERY HARD TO DETERMINE 2913 02:21:37,040 --> 02:21:39,720 BECAUSE THERE ARE THE COSTS OF 2914 02:21:39,720 --> 02:21:40,440 MANUFACTURING THE DEVICE. 2915 02:21:40,440 --> 02:21:44,000 BUT MOST OF THE COSTS ARE 2916 02:21:44,000 --> 02:21:47,080 RELATED TO THE PROCEDURE TO 2917 02:21:47,080 --> 02:21:48,880 IMPLANT THE DEVICE AND WHICH IS 2918 02:21:48,880 --> 02:21:52,480 THE SURGICAL PROCEDURE AND THE 2919 02:21:52,480 --> 02:21:54,280 BRIEF HOSPITALIZATION AND THEN 2920 02:21:54,280 --> 02:21:56,680 THE MANAGEMENT OF THE DEVICE, 2921 02:21:56,680 --> 02:21:59,840 THE MEDICAL CARE. 2922 02:21:59,840 --> 02:22:02,560 SO THERE ARE -- AND THE COSTS OF 2923 02:22:02,560 --> 02:22:05,200 THE SURGERY AND THE OTHER 2924 02:22:05,200 --> 02:22:06,440 PROCEDURES ARE DETERMINED BY THE 2925 02:22:06,440 --> 02:22:07,440 HOSPITAL AND THE ACADEMIC 2926 02:22:07,440 --> 02:22:08,240 INSTITUTION. 2927 02:22:08,240 --> 02:22:10,400 THEY SET THOSE COSTS. 2928 02:22:10,400 --> 02:22:13,760 SO A COMPANY LIKE NEUROPACE OR 2929 02:22:13,760 --> 02:22:17,520 ABBOTT OR MEDTRONIC OR THE 2930 02:22:17,520 --> 02:22:18,720 TINIEST COMPANY HAS NO CONTROL 2931 02:22:18,720 --> 02:22:20,880 OVER WHAT THE MEDICAL COSTS 2932 02:22:20,880 --> 02:22:23,880 ACTUALLY ARE BECAUSE THOSE ARE 2933 02:22:23,880 --> 02:22:28,080 NOT SET. 2934 02:22:28,080 --> 02:22:29,960 SO THEY HAVE CONTROL OVER THE 2935 02:22:29,960 --> 02:22:31,480 DEVICE AND THEY HAVE CONTROL 2936 02:22:31,480 --> 02:22:33,760 OVER WHAT EVER SUPPORT IF 2937 02:22:33,760 --> 02:22:34,760 THEY'RE CLINICAL ENGINEERS AND 2938 02:22:34,760 --> 02:22:36,240 PEOPLE IN OR WITH THE DEVICE 2939 02:22:36,240 --> 02:22:37,560 THEY HAVE CONTROL OVER THAT. 2940 02:22:37,560 --> 02:22:38,920 BUT THEY HAVE NO CONTROL OF ANY 2941 02:22:38,920 --> 02:22:42,400 OF THE OTHER, WHICH IS WHY IT 2942 02:22:42,400 --> 02:22:52,920 HAS TO BE DONE MULTIPLE PARTIES. 2943 02:23:06,160 --> 02:23:07,480 >> AND THE ANALYSIS GROUP IN 2944 02:23:07,480 --> 02:23:08,680 THE CENTER FOR CLINICAL 2945 02:23:08,680 --> 02:23:10,640 STANDARDS AND QUALITY. 2946 02:23:10,640 --> 02:23:11,720 PART OF THE CENTERS FOR MEDICARE 2947 02:23:11,720 --> 02:23:15,600 AND MEDICAID SERVICES ON THE 2948 02:23:15,600 --> 02:23:20,640 MEDICARE SIDE. 2949 02:23:20,640 --> 02:23:20,880 DR. LI. 2950 02:23:20,880 --> 02:23:25,800 >> GOOD AFTERNOON. 2951 02:23:25,800 --> 02:23:26,840 WANT TO THANK YOU FOR THE 2952 02:23:26,840 --> 02:23:28,880 OPPORTUNITY TO TALK ABOUT THE 2953 02:23:28,880 --> 02:23:29,680 MEDICARE PERSPECTIVE ON 2954 02:23:29,680 --> 02:23:30,240 POST-TRIAL CARE. 2955 02:23:30,240 --> 02:23:34,120 I SEE THE SLIDES ARE COMING UP. 2956 02:23:34,120 --> 02:23:41,360 I'LL GO AHEAD AND START. 2957 02:23:41,360 --> 02:23:41,800 TALKING. 2958 02:23:41,800 --> 02:23:43,120 AND NEXT SLIDE. 2959 02:23:43,120 --> 02:23:46,160 I WANTED TO GET THIS PARTICULAR 2960 02:23:46,160 --> 02:23:47,200 DISCLAIMER THIS PRESENTATION IS 2961 02:23:47,200 --> 02:23:50,920 NOT A LEGAL DOCUMENT. 2962 02:23:50,920 --> 02:23:52,120 IF THERE'S FURTHER QUESTIONS 2963 02:23:52,120 --> 02:23:54,240 ABOUT WHAT MEDICARE PROVIDERS, 2964 02:23:54,240 --> 02:23:57,960 THE CRITERIA ARE, SO IT'S 2965 02:23:57,960 --> 02:24:00,840 COVERAGE DECISIONS, THEN ONE 2966 02:24:00,840 --> 02:24:02,280 WOULD HAVE TO GO BACK LOOK AT 2967 02:24:02,280 --> 02:24:03,480 THE RULES AND REGULATIONS 2968 02:24:03,480 --> 02:24:07,480 RELATED TO THAT QUESTION. 2969 02:24:07,480 --> 02:24:10,720 SO NEXT SLIDE, PLEASE. 2970 02:24:10,720 --> 02:24:14,360 SO OUR WORK AT MEDICARE, I WORK 2971 02:24:14,360 --> 02:24:15,480 AS PREVIOUSLY DESCRIBED COVERAGE 2972 02:24:15,480 --> 02:24:17,720 ANALYSIS GROUP. 2973 02:24:17,720 --> 02:24:20,360 WHAT THAT MEANS IS THAT MY GROUP 2974 02:24:20,360 --> 02:24:22,160 DETERMINES WHAT ITEMS OR 2975 02:24:22,160 --> 02:24:24,880 SERVICES SHOULD BE COVERED AND 2976 02:24:24,880 --> 02:24:26,920 THEREFORE REIMBURSED AND THEN 2977 02:24:26,920 --> 02:24:29,440 WHAT I'M GOING TO DO IS DESCRIBE 2978 02:24:29,440 --> 02:24:31,440 THAT PROCESS OF COMING TO GET A 2979 02:24:31,440 --> 02:24:31,920 DECISION. 2980 02:24:31,920 --> 02:24:35,640 AND SO UNDERNEATH ALL OF THIS IS 2981 02:24:35,640 --> 02:24:37,480 THE CONTRACT THAT OUR AGENCY WAS 2982 02:24:37,480 --> 02:24:38,520 ESTABLISHED BY THE SOCIAL 2983 02:24:38,520 --> 02:24:42,760 SECURITY ACT OF 1965. 2984 02:24:42,760 --> 02:24:44,440 AND HOW WE DETERMINE WHAT'S 2985 02:24:44,440 --> 02:24:47,760 COVERED OR WHAT'S REIMBURSED IS 2986 02:24:47,760 --> 02:24:50,320 BASED ON THE EVIDENCE AND THE 2987 02:24:50,320 --> 02:24:53,640 EVIDENCE SHOWS THAT THE BIAS, 2988 02:24:53,640 --> 02:24:56,360 THE ITEM OR DEVICE IS REASONABLY 2989 02:24:56,360 --> 02:24:57,480 NECESSARY FOR DIAGNOSIS 2990 02:24:57,480 --> 02:25:00,080 CONFIDENT TREATMENT OR INJURY OR 2991 02:25:00,080 --> 02:25:03,440 TIM PROVES THE FUNCTION OF A 2992 02:25:03,440 --> 02:25:04,560 MALFORMED BODY. 2993 02:25:04,560 --> 02:25:05,800 AND NEXT COUPLE OF SLIDES I'LL 2994 02:25:05,800 --> 02:25:08,640 DESCRIBE HOW TO DO THAT. 2995 02:25:08,640 --> 02:25:10,080 NEXT SLIDE, PLEASE. 2996 02:25:10,080 --> 02:25:12,600 AND SO FIRST QUESTION IS WHAT IS 2997 02:25:12,600 --> 02:25:14,320 ACTUAL COVERAGE DETERMINATION. 2998 02:25:14,320 --> 02:25:16,000 THIS IS HOW WE DETERMINE WHAT 2999 02:25:16,000 --> 02:25:17,520 SHOULD BE COVERED, WHICH ITEM OR 3000 02:25:17,520 --> 02:25:20,760 DEVICE SHOULD BE COVERED ON A 3001 02:25:20,760 --> 02:25:21,200 NATIONAL BASIS. 3002 02:25:21,200 --> 02:25:24,920 SO WHAT WE DO BRIEFLY IS REVIEW 3003 02:25:24,920 --> 02:25:26,920 THE PUBLISHED EVIDENCE TO 3004 02:25:26,920 --> 02:25:28,880 DETERMINE WHETHER OR NOT THAT 3005 02:25:28,880 --> 02:25:31,880 ITEM OR DEVICE IN FACT IMPROVES 3006 02:25:31,880 --> 02:25:33,480 A HEALTH OUTCOME THAT'S 3007 02:25:33,480 --> 02:25:36,080 MEANINGFUL TO THE MEDICARE 3008 02:25:36,080 --> 02:25:36,400 POPULATION. 3009 02:25:36,400 --> 02:25:37,680 SO WE GO AHEAD REVIEW THE 3010 02:25:37,680 --> 02:25:39,240 PUBLISHED EVIDENCE. 3011 02:25:39,240 --> 02:25:41,160 LOOK FOR QUALITY, STRENGTHEN THE 3012 02:25:41,160 --> 02:25:42,720 TOTAL OF THE EVIDENCE, WHETHER 3013 02:25:42,720 --> 02:25:44,680 TO DETERMINE WHAT QUALITY IT'S 3014 02:25:44,680 --> 02:25:46,840 AT, WHAT TYPE OF STRENGTH IT HAS 3015 02:25:46,840 --> 02:25:48,920 AND WHETHER OR NOT IT IMPROVES 3016 02:25:48,920 --> 02:25:50,680 MEANINGFUL PATIENT-CENTERED 3017 02:25:50,680 --> 02:25:50,960 OUTCOMES. 3018 02:25:50,960 --> 02:25:53,920 AND TYPICALLY OUR GOLD STANDARD 3019 02:25:53,920 --> 02:25:56,760 OUTCOME IS MORTALITY THOUGH 3020 02:25:56,760 --> 02:25:59,320 DEPENDING ON THE ITEM OR DEVICE 3021 02:25:59,320 --> 02:26:00,920 WE'LL USE OTHER OUTCOMES. 3022 02:26:00,920 --> 02:26:03,200 NEXT SLIDE, PLEASE. 3023 02:26:03,200 --> 02:26:04,000 AND AS PART THAT HAD NATIONAL 3024 02:26:04,000 --> 02:26:07,040 COVERAGE DETERMINATION WE WILL 3025 02:26:07,040 --> 02:26:09,440 GO THROUGH THE EVIDENCE IF WE 3026 02:26:09,440 --> 02:26:12,680 FIND THE PUBLISHED EVIDENCE IS 3027 02:26:12,680 --> 02:26:13,680 INSUFFICIENT TO MAKE A 3028 02:26:13,680 --> 02:26:16,520 APPROPRIATION DECISION THE 3029 02:26:16,520 --> 02:26:20,040 DEVICE TO COVER OR NOT COVER IT. 3030 02:26:20,040 --> 02:26:22,080 WE HAVE A SEPARATE PATHWAY WHERE 3031 02:26:22,080 --> 02:26:28,720 WE WILL SUPPORT A CLINICAL TRIAL 3032 02:26:28,720 --> 02:26:29,640 WHICH THE CLINICAL TRIALS 3033 02:26:29,640 --> 02:26:31,440 DEVELOPING THE EVIDENCE TO HELP 3034 02:26:31,440 --> 02:26:33,920 US BETTER UNDERSTAND WHETHER OR 3035 02:26:33,920 --> 02:26:37,280 NOT THE ITEM WAS SERVICE RELATED 3036 02:26:37,280 --> 02:26:39,600 TO THE OUTCOME OF THE MEDICARE 3037 02:26:39,600 --> 02:26:39,880 POPULATION. 3038 02:26:39,880 --> 02:26:43,400 THOSE CLINICAL TRIALS COULD 3039 02:26:43,400 --> 02:26:45,520 INCLUDE RANDOMIZED OBSERVATIONAL 3040 02:26:45,520 --> 02:26:47,240 STUDIES REGISTRATION STUDIES AND 3041 02:26:47,240 --> 02:26:50,280 JUST THOSE DIFFERENT TYPES OF 3042 02:26:50,280 --> 02:26:54,040 CLINICAL TRIALS. 3043 02:26:54,040 --> 02:26:55,440 AND SO NEXT SLIDE PLEASE. 3044 02:26:55,440 --> 02:26:59,000 THE EXAMPLE I WANT TO USE TODAY 3045 02:26:59,000 --> 02:27:01,480 IS THIS PARTICULAR NATIONAL 3046 02:27:01,480 --> 02:27:02,760 COVERAGE DETERMINATION WHICH WE 3047 02:27:02,760 --> 02:27:04,920 HAD COMPLETED A NUMBER OF YEARS 3048 02:27:04,920 --> 02:27:08,600 AGO IT'S LOOKING AT VAGUS NERVE 3049 02:27:08,600 --> 02:27:12,080 STIMULATION OR TRD. 3050 02:27:12,080 --> 02:27:16,800 AND SO NEXT SLIDE, PLEASE WE 3051 02:27:16,800 --> 02:27:18,680 LOOK AT EVIDENCE AND DETERMINE 3052 02:27:18,680 --> 02:27:20,800 THAT LOOKING AT OVERALL QUALITY 3053 02:27:20,800 --> 02:27:23,360 OF THE EVIDENCE THAT THE 3054 02:27:23,360 --> 02:27:26,080 EVIDENCE IS REALLY PROMISING BUT 3055 02:27:26,080 --> 02:27:27,120 NOT CONVINCING. 3056 02:27:27,120 --> 02:27:30,520 CONCERNS ABOUT THE QUALITY IN 3057 02:27:30,520 --> 02:27:34,360 TERMS OF EPIDEMIOLOGIC ISSUES, 3058 02:27:34,360 --> 02:27:35,560 FOUND THE STRENGTH OF EVIDENCE 3059 02:27:35,560 --> 02:27:37,760 WAS NOT STRONG ENOUGH FOR US TO 3060 02:27:37,760 --> 02:27:42,440 ALLOW US TO MAKE AN APPROPRIATE 3061 02:27:42,440 --> 02:27:49,440 DECISION WHETHER OR NOT VNS OR 3062 02:27:49,440 --> 02:27:51,160 VAGUS NERVE THAT TREATS 3063 02:27:51,160 --> 02:27:53,920 TREATMENT DEPRESSION AS A RESULT 3064 02:27:53,920 --> 02:27:56,160 WE PROPOSE THE PATHWAY COVERAGE 3065 02:27:56,160 --> 02:27:57,680 WITH EVIDENCE DEVELOPMENT. 3066 02:27:57,680 --> 02:28:00,320 NEXT SLIDE, PLEASE. 3067 02:28:00,320 --> 02:28:01,920 AND SO WHAT THAT MEANS IS THAT 3068 02:28:01,920 --> 02:28:03,320 THE NEXT COUPLE OF SLIDES IS THE 3069 02:28:03,320 --> 02:28:06,320 POLICY THAT I WILL NOT GO 3070 02:28:06,320 --> 02:28:07,520 THROUGH THE EVIDENCE THAT WAS A 3071 02:28:07,520 --> 02:28:10,920 LONG PROCESS TO GET TO THIS 3072 02:28:10,920 --> 02:28:11,760 POINT. 3073 02:28:11,760 --> 02:28:14,200 BUT SO IN ESSENCE WE DECIDED WE 3074 02:28:14,200 --> 02:28:16,000 WOULD COVER FDA APPROVED VAGUS 3075 02:28:16,000 --> 02:28:18,280 NERVE STIMULATION DEVICES FROM 3076 02:28:18,280 --> 02:28:19,440 TREATMENT RESISTANT DEPRESSION 3077 02:28:19,440 --> 02:28:21,080 THROUGH THIS PATHWAY WE CALLED 3078 02:28:21,080 --> 02:28:22,840 COVERAGE WITH EVIDENCE 3079 02:28:22,840 --> 02:28:23,360 DEVELOPMENT. 3080 02:28:23,360 --> 02:28:30,880 AND SO WHEN DNS IS OFFERED FROM 3081 02:28:30,880 --> 02:28:34,920 A CNS APPROVED CLINICAL TRIAL AT 3082 02:28:34,920 --> 02:28:36,920 LEAST ONE YEAR WE COULD COVER 3083 02:28:36,920 --> 02:28:40,240 THE DEVICE AND SERVICES DURING 3084 02:28:40,240 --> 02:28:42,720 THE DURATION OF THE RANDOMIZED 3085 02:28:42,720 --> 02:28:44,480 CLINICAL TRIAL. 3086 02:28:44,480 --> 02:28:47,520 HOWEVER, WE WOULD ALSO -- WHAT 3087 02:28:47,520 --> 02:28:50,920 WE DID WAS MAKE SURE THE 3088 02:28:50,920 --> 02:28:52,280 CLINICAL TRIAL WAS VALID AND 3089 02:28:52,280 --> 02:28:53,400 WELL-DESIGNED ONE IN THE SENSE 3090 02:28:53,400 --> 02:28:56,800 WE HAD ONLY COVERED THE STUDY IF 3091 02:28:56,800 --> 02:28:58,040 IT, IF THE MAIN RESEARCH 3092 02:28:58,040 --> 02:28:59,240 QUESTION, THE PURPOSE OF THE 3093 02:28:59,240 --> 02:29:02,120 STUDY WAS TO ADDRESS WHETHER OR 3094 02:29:02,120 --> 02:29:04,360 NOT DNS IMPROVES HEALTH OUTCOMES 3095 02:29:04,360 --> 02:29:06,360 FOR TRD PATIENTS. 3096 02:29:06,360 --> 02:29:09,560 SO WE REQUIRED THAT THE CLINICAL 3097 02:29:09,560 --> 02:29:11,600 STUDIES ANSWER THERE'S A LARGE 3098 02:29:11,600 --> 02:29:12,560 NUMBER OF RESEARCH QUESTIONS. 3099 02:29:12,560 --> 02:29:15,560 I ONLY PUT TWO OF THEM HERE. 3100 02:29:15,560 --> 02:29:16,960 10 OR 15 QUESTIONS. 3101 02:29:16,960 --> 02:29:19,440 IN TERMS OF BREVITY. 3102 02:29:19,440 --> 02:29:21,800 THE MAIN QUESTION IS THAT WE 3103 02:29:21,800 --> 02:29:22,640 WANT THE CLINICAL TRIAL TO 3104 02:29:22,640 --> 02:29:25,440 ANSWER IS WHAT WAS THE RATE OF 3105 02:29:25,440 --> 02:29:28,560 RESPONSE OF USING THE VNS DEVICE 3106 02:29:28,560 --> 02:29:31,440 TO TREAT TREATMENT RESISTANT 3107 02:29:31,440 --> 02:29:32,240 DEPRESSION PATIENTS. 3108 02:29:32,240 --> 02:29:33,360 ANOTHER MAIN QUESTION WHAT IS 3109 02:29:33,360 --> 02:29:35,880 THE RATE OF REMISSION WHEN THE 3110 02:29:35,880 --> 02:29:38,120 VNS DEVICE IS USED FOR TREATMENT 3111 02:29:38,120 --> 02:29:38,920 RESISTANT DEPRESSION. 3112 02:29:38,920 --> 02:29:40,560 SO THERE'S A WHOLE LIKE I SAID 3113 02:29:40,560 --> 02:29:42,560 THERE'S A WHOLE LARGER NUMBER OF 3114 02:29:42,560 --> 02:29:44,520 OTHER QUESTIONS THAT WERE VERY 3115 02:29:44,520 --> 02:29:46,080 IMPORTANT BUT THE POINT WAS THE 3116 02:29:46,080 --> 02:29:48,240 PURPOSE OF THIS STUDY WAS THAT 3117 02:29:48,240 --> 02:29:50,800 IT HAD TO ANSWER THE QUESTION OF 3118 02:29:50,800 --> 02:29:53,600 WHETHER OR NOT DNS IN FACT 3119 02:29:53,600 --> 02:29:55,200 IMPROVES HEALTH OUTCOME OF 3120 02:29:55,200 --> 02:29:56,840 MAJORITY OF PATIENTS. 3121 02:29:56,840 --> 02:29:58,640 NEXT SLIDE, PLEASE. 3122 02:29:58,640 --> 02:30:02,440 AS PART OF THE DECISION, WE ALSO 3123 02:30:02,440 --> 02:30:03,640 INCLUDE PATIENT CRITERIA THAT IS 3124 02:30:03,640 --> 02:30:06,160 THE PATIENT HAD TO REACH CERTAIN 3125 02:30:06,160 --> 02:30:08,400 ENROLLMENT CRITERIA TO BE A PART 3126 02:30:08,400 --> 02:30:09,480 OF THE CLINICAL TRIAL. 3127 02:30:09,480 --> 02:30:12,280 SO THE PATIENT HAD TO BE, HAD TO 3128 02:30:12,280 --> 02:30:14,320 HAVE HAD A MAJOR DEPRESSIVE 3129 02:30:14,320 --> 02:30:15,880 EPISODE FOR AT LEAST TWO YEARS 3130 02:30:15,880 --> 02:30:19,000 OR MORE IN THE PAST TWO AND A 3131 02:30:19,000 --> 02:30:20,560 HALF YEARS, TWO YEARS. 3132 02:30:20,560 --> 02:30:24,560 THE PATIENT WOULD ALSO HAVE TO 3133 02:30:24,560 --> 02:30:26,320 HAVE HAD FOUR PRIOR FAILED 3134 02:30:26,320 --> 02:30:29,120 TREATMENTS OF ADEQUATE DOSE AND 3135 02:30:29,120 --> 02:30:31,480 DURATION OF THE DRUG TO QUALIFY 3136 02:30:31,480 --> 02:30:32,720 FOR THIS PARTICULAR STUDY. 3137 02:30:32,720 --> 02:30:34,000 AND JUST SKIPPING DOWN TO THE 3138 02:30:34,000 --> 02:30:37,040 LAST BULLET THAT I THINK THIS 3139 02:30:37,040 --> 02:30:39,360 PARTICULAR CRITERIA IS RELEVANT 3140 02:30:39,360 --> 02:30:42,320 TO THE WORKSHOP IN TERMS OF 3141 02:30:42,320 --> 02:30:42,920 POST-TRIAL RESPONSIBILITIES. 3142 02:30:42,920 --> 02:30:46,200 AT LEAST FROM THE MEDICARE, FROM 3143 02:30:46,200 --> 02:30:48,840 MY AGENCY'S PERSPECTIVE. 3144 02:30:48,840 --> 02:30:49,800 SO INDIVIDUALS WHO RECEIVE THE 3145 02:30:49,800 --> 02:30:52,240 PLACEBO VNS WILL BE OFFERED 3146 02:30:52,240 --> 02:30:53,640 ACTIVE VNS AT THE END OF THE 3147 02:30:53,640 --> 02:30:54,920 TRIAL. 3148 02:30:54,920 --> 02:30:58,520 AND SO WHAT THAT MEANS IS THAT 3149 02:30:58,520 --> 02:30:59,840 AFTER THE CLINICAL TRIAL IS 3150 02:30:59,840 --> 02:31:01,600 DONE, THOSE INDIVIDUALS IN THE 3151 02:31:01,600 --> 02:31:03,480 CONTROL GROUP, THOSE WHO WERE 3152 02:31:03,480 --> 02:31:07,480 GETTING A PLACEBO VNS DEVICE 3153 02:31:07,480 --> 02:31:11,720 WILL BE OFFERED THE ACTIVE VNS 3154 02:31:11,720 --> 02:31:12,840 DEVICE, THEY WOULD RECEIVE THE 3155 02:31:12,840 --> 02:31:13,920 DEVICE THAT WAS BEING USED. 3156 02:31:13,920 --> 02:31:16,120 THIS WOULD BE AT THE END OF THE 3157 02:31:16,120 --> 02:31:17,000 TRIAL. 3158 02:31:17,000 --> 02:31:20,440 AND THEN THIS WAS WRITTEN INTO 3159 02:31:20,440 --> 02:31:21,160 THE DECISION, THE DETERMINATION. 3160 02:31:21,160 --> 02:31:24,520 NEXT SLIDE, PLEASE. 3161 02:31:24,520 --> 02:31:27,920 AND SO AS I STATED BEFORE, PART 3162 02:31:27,920 --> 02:31:29,240 OF THIS DECISION WE INCLUDE 3163 02:31:29,240 --> 02:31:32,880 WHAT'S CALLED A CD PATHWAY, 3164 02:31:32,880 --> 02:31:35,000 COVERAGE DEPENDENT PATHWAY THE 3165 02:31:35,000 --> 02:31:36,960 STUDIES HAD TO MEET 13 CRITERIA. 3166 02:31:36,960 --> 02:31:38,000 BELOW THERE WERE ONLY FOUR OF 3167 02:31:38,000 --> 02:31:40,880 THOSE CRITERIA AND I INCLUDED 3168 02:31:40,880 --> 02:31:45,440 TWO OF THE CRITERIA THAT WE 3169 02:31:45,440 --> 02:31:45,760 CONSIDERED. 3170 02:31:45,760 --> 02:31:47,480 NOT JUST CONSIDERING OF IMPORT 3171 02:31:47,480 --> 02:31:49,320 BUT WE CONSIDERED IT KEY TO THE 3172 02:31:49,320 --> 02:31:50,000 CLINICAL TRIAL. 3173 02:31:50,000 --> 02:31:52,880 SO AS I STATED BEFORE, THE FIRST 3174 02:31:52,880 --> 02:31:54,760 BULLET, THE PRINCIPAL PURPOSE OF 3175 02:31:54,760 --> 02:31:56,400 THE STUDY IS TO TEST WHETHER OR 3176 02:31:56,400 --> 02:31:58,640 NOT THE ITEM OR SERVICE 3177 02:31:58,640 --> 02:31:59,960 MEANINGFULLY IMPROVES THE HEALTH 3178 02:31:59,960 --> 02:32:00,480 OUTCOMES OF AFFECTED 3179 02:32:00,480 --> 02:32:02,360 BENEFICIARIES WHO ARE 3180 02:32:02,360 --> 02:32:03,280 REPRESENTED BY THE SUBJECT. 3181 02:32:03,280 --> 02:32:05,800 SO CLEARLY THE STUDY HAD TO SHOW 3182 02:32:05,800 --> 02:32:07,280 IMPROVEMENT IN HEALTH OUTCOME. 3183 02:32:07,280 --> 02:32:08,880 IN THIS CASE IT WAS THE RATE OF 3184 02:32:08,880 --> 02:32:10,400 RESPONSE OF THE RATE OF 3185 02:32:10,400 --> 02:32:13,480 REMISSION WITH USE OF THE VNS 3186 02:32:13,480 --> 02:32:14,960 DEVICE VAGUS NERVE STIMULATION 3187 02:32:14,960 --> 02:32:17,040 DEVICE IN TERMS OF ADDRESSING 3188 02:32:17,040 --> 02:32:19,440 TREATMENT RESISTANT DEPRESSION. 3189 02:32:19,440 --> 02:32:23,080 AND IF YOU LOOK AT THE FOURTH 3190 02:32:23,080 --> 02:32:24,640 BULLET, STUDY DESIGN IS 3191 02:32:24,640 --> 02:32:25,880 METHODOLOGICALLY APPROPRIATE IN 3192 02:32:25,880 --> 02:32:27,360 ANTICIPATED NUMBER OF THE 3193 02:32:27,360 --> 02:32:30,360 SUBJECTS SUFFICIENT TO ANSWER 3194 02:32:30,360 --> 02:32:31,200 THE RESEARCH QUESTIONS BEING 3195 02:32:31,200 --> 02:32:32,520 ASKED ACTUAL COVERAGE 3196 02:32:32,520 --> 02:32:32,880 DETERMINATION. 3197 02:32:32,880 --> 02:32:35,400 WHAT THAT MEANS IS THAT WE WOULD 3198 02:32:35,400 --> 02:32:36,560 REVIEW THESE CLINICAL TRIALS, 3199 02:32:36,560 --> 02:32:38,840 WHETHER IT'S A REGISTRY OR 3200 02:32:38,840 --> 02:32:40,560 DOUBLE BLIND RANDOMIZED CLINICAL 3201 02:32:40,560 --> 02:32:42,400 TRIAL TO MAKE SURE THE 3202 02:32:42,400 --> 02:32:43,360 METHODOLOGY WAS APPROPRIATE. 3203 02:32:43,360 --> 02:32:46,400 THAT IS, THAT THERE'S COMPARISON 3204 02:32:46,400 --> 02:32:46,720 GROUP. 3205 02:32:46,720 --> 02:32:48,360 THERE'S A CONTROL GROUP SO THAT 3206 02:32:48,360 --> 02:32:49,560 YOU CAN COMPARE THE EFFECT OF 3207 02:32:49,560 --> 02:32:54,560 THE VNS DEVICE IN TREATMENT 3208 02:32:54,560 --> 02:32:55,280 RESISTANT DEPRESSION PATIENTS 3209 02:32:55,280 --> 02:32:56,680 AND THERE'S DOUBLE BLINDING IF 3210 02:32:56,680 --> 02:32:59,080 IT'S RANDOMIZED CLINICAL TRIAL. 3211 02:32:59,080 --> 02:33:01,480 IF THE REGISTER THAT IT HAD A 3212 02:33:01,480 --> 02:33:02,680 LARGE ENOUGH CATCHMENT AREA TO 3213 02:33:02,680 --> 02:33:06,240 GET A SENSE OF WHAT'S HAPPENING 3214 02:33:06,240 --> 02:33:06,520 NATIONALLY. 3215 02:33:06,520 --> 02:33:07,920 WE'LL TALK ABOUT SAMPLE SIZE. 3216 02:33:07,920 --> 02:33:09,880 WE WANT TO MAKE SURE THAT THE 3217 02:33:09,880 --> 02:33:12,920 STUDY WAS POWERED ADEQUATELY TO 3218 02:33:12,920 --> 02:33:15,000 ANSWER THE VARIOUS RESEARCH 3219 02:33:15,000 --> 02:33:15,800 QUESTIONS, A SAMPLE SIZE WAS 3220 02:33:15,800 --> 02:33:17,960 LARGE ENOUGH, ENROLLMENT WAS 3221 02:33:17,960 --> 02:33:19,040 LONG ENOUGH. 3222 02:33:19,040 --> 02:33:20,280 FOLLOW-UP WAS APPROPRIATE TO 3223 02:33:20,280 --> 02:33:22,920 MAKE SURE THAT THERE'S ADEQUATE 3224 02:33:22,920 --> 02:33:24,880 FOLLOW-UP FOR AS MANY PATIENTS 3225 02:33:24,880 --> 02:33:28,120 AS POSSIBLE AND WE LOOKED AT A 3226 02:33:28,120 --> 02:33:31,000 LOT OF THE OTHER VARIOUS 3227 02:33:31,000 --> 02:33:31,680 HEMATOLOGIC QUESTIONS CONCERNS 3228 02:33:31,680 --> 02:33:35,160 ABOUT THE LIMITATIONS THAT MIGHT 3229 02:33:35,160 --> 02:33:38,720 BE EXISTING IN THESE CLINICAL 3230 02:33:38,720 --> 02:33:40,920 TRIALS. 3231 02:33:40,920 --> 02:33:44,160 NEXT SLIDE, PLEASE. 3232 02:33:44,160 --> 02:33:48,200 AND THESE LAST TWO OR LAST THREE 3233 02:33:48,200 --> 02:33:49,800 BULLETS, I THINK, ALSO ADDRESS, 3234 02:33:49,800 --> 02:33:52,200 I THINK, THE QUESTIONS RAISED IN 3235 02:33:52,200 --> 02:33:53,560 THIS PARTICULAR WORKSHOP RELATED 3236 02:33:53,560 --> 02:33:54,440 TO POST-TRIAL RESPONSIBILITIES. 3237 02:33:54,440 --> 02:33:56,880 AT LEAST FROM THE CMS 3238 02:33:56,880 --> 02:33:57,200 PERSPECTIVE. 3239 02:33:57,200 --> 02:33:58,280 IF YOU LOOKED AT THE FIRST 3240 02:33:58,280 --> 02:33:58,520 BULLET. 3241 02:33:58,520 --> 02:34:00,880 I'LL GO AHEAD AND READ IT. 3242 02:34:00,880 --> 02:34:02,600 WE'RE THINKING OF NONCOVERAGE 3243 02:34:02,600 --> 02:34:02,880 EDUCATION. 3244 02:34:02,880 --> 02:34:03,960 THE FIRST TWO BULLETS. 3245 02:34:03,960 --> 02:34:06,280 THE FIRST ONE IS DNS IS 3246 02:34:06,280 --> 02:34:08,680 NONCOVERED FOR THE TREATMENT OF 3247 02:34:08,680 --> 02:34:12,400 TRD WHEN FURNISHED OUTSIDE THE 3248 02:34:12,400 --> 02:34:13,480 CMS STUDY. 3249 02:34:13,480 --> 02:34:15,520 MEANING THAT IF VNS IS BEING 3250 02:34:15,520 --> 02:34:17,160 USED AT A STUDY WE HAD NOT 3251 02:34:17,160 --> 02:34:19,480 LOOKED AT HAD NOT APPROVED 3252 02:34:19,480 --> 02:34:23,320 YET -- THANK YOU -- THIS LAST 3253 02:34:23,320 --> 02:34:24,960 SLIDE, THEN IT'S OUTSIDE OF THE 3254 02:34:24,960 --> 02:34:28,920 CN APPROVED CD STUDY WE'RE NOT 3255 02:34:28,920 --> 02:34:30,720 GOING TO COMPLEMENT IT. 3256 02:34:30,720 --> 02:34:32,480 THAT MAKES SENSE HADN'T LOOKED 3257 02:34:32,480 --> 02:34:33,680 AT THE CD STUDY THE CLINICAL 3258 02:34:33,680 --> 02:34:36,680 TRIAL THAT WE WILL NOT COVER THE 3259 02:34:36,680 --> 02:34:37,000 DEVICE. 3260 02:34:37,000 --> 02:34:39,400 THE SECOND BULLET IS INDICATIONS 3261 02:34:39,400 --> 02:34:42,200 OF VNS FOR TREATMENT OF 3262 02:34:42,200 --> 02:34:43,080 DEPRESSION NOT NATURALLY COVERED 3263 02:34:43,080 --> 02:34:44,320 THAT IS IF THE DEVICE IS BEING 3264 02:34:44,320 --> 02:34:46,880 USED OUTSIDE OF TREATMENT OF 3265 02:34:46,880 --> 02:34:47,760 RESISTANT -- OUTSIDE OF 3266 02:34:47,760 --> 02:34:49,320 TREATMENT RESISTANT DEPRESSION, 3267 02:34:49,320 --> 02:34:51,360 THAT WE'RE NOT GOING TO COVER 3268 02:34:51,360 --> 02:34:53,200 THE DEVICE. 3269 02:34:53,200 --> 02:34:56,000 THE LAST BULLET IS PATIENTS ARE 3270 02:34:56,000 --> 02:34:59,320 IMPLANTED WITH A VNS DEVICE FOR 3271 02:34:59,320 --> 02:35:02,680 GRD MAY RECEIVE A VNS DEVICE 3272 02:35:02,680 --> 02:35:03,840 REPLACEMENT IF IT'S REQUIRED DUE 3273 02:35:03,840 --> 02:35:06,640 TO END OF BATTERY LIFE OR ANY 3274 02:35:06,640 --> 02:35:10,120 OTHER DEVICE-RELATED MALFUN 3275 02:35:10,120 --> 02:35:11,520 MALFUNCTION, MEANING -- I THINK 3276 02:35:11,520 --> 02:35:12,840 THIS IS RELEVANT FOR THIS 3277 02:35:12,840 --> 02:35:14,640 PARTICULAR WORKSHOP -- IF THE 3278 02:35:14,640 --> 02:35:16,080 VNS DEVICE NEEDS TO BE REPLACED 3279 02:35:16,080 --> 02:35:19,400 BECAUSE THE BATTERY PROBLEMS OR 3280 02:35:19,400 --> 02:35:21,760 ANOTHER DEVICE RELATED 3281 02:35:21,760 --> 02:35:23,600 MALFUNCTION, CMS WILL REPLACE 3282 02:35:23,600 --> 02:35:24,280 THE DEVICE. 3283 02:35:24,280 --> 02:35:25,240 NEXT SLIDE, PLEASE. 3284 02:35:25,240 --> 02:35:26,960 SO I THINK WE SHOULD BE ON THE 3285 02:35:26,960 --> 02:35:27,320 LAST SLIDE. 3286 02:35:27,320 --> 02:35:27,600 NEXT SLIDE. 3287 02:35:27,600 --> 02:35:37,840 ANY QUESTIONS? 3288 02:35:38,280 --> 02:35:40,200 >> THERE'S TIME FOR ONE 3289 02:35:40,200 --> 02:35:40,480 QUESTION. 3290 02:35:40,480 --> 02:35:40,880 >> OKAY. 3291 02:35:40,880 --> 02:35:43,440 >> CAN I ASK IT? 3292 02:35:43,440 --> 02:35:44,160 >> GO AHEAD. 3293 02:35:44,160 --> 02:35:46,640 >> SO I JUST WANTED TO MAKE 3294 02:35:46,640 --> 02:35:48,440 SURE -- THANK YOU DR. LI FOR 3295 02:35:48,440 --> 02:35:49,120 THAT PRESENTATION. 3296 02:35:49,120 --> 02:35:50,840 MAKE SURE I UNDERSTAND. 3297 02:35:50,840 --> 02:35:54,960 IF A DEVICE IS IN A TRIAL THAT 3298 02:35:54,960 --> 02:35:56,760 COMES UNDER CED, THEN MEDICARE 3299 02:35:56,760 --> 02:35:57,800 WILL PAY FOR IT. 3300 02:35:57,800 --> 02:35:59,960 IF IT'S ALREADY, IF THE DEVICE 3301 02:35:59,960 --> 02:36:02,920 HAS ALREADY BEEN APPROVED UNDER 3302 02:36:02,920 --> 02:36:03,440 A NATIONAL COVERAGE 3303 02:36:03,440 --> 02:36:04,920 DETERMINATION THEN CMS OR 3304 02:36:04,920 --> 02:36:07,120 MEDICARE WILL PAY FOR IT. 3305 02:36:07,120 --> 02:36:08,120 WHAT ABOUT THE KINDS OF 3306 02:36:08,120 --> 02:36:09,520 SITUATIONS THAT PEOPLE ARE 3307 02:36:09,520 --> 02:36:12,000 TALKING ABOUT EARLIER WHERE IT'S 3308 02:36:12,000 --> 02:36:14,240 IN A TRIAL THAT'S OVER, THAT IT 3309 02:36:14,240 --> 02:36:16,800 IS NOT THE -- THE DEVICE IS NOT 3310 02:36:16,800 --> 02:36:18,280 BEING PURSUED FOR THAT 3311 02:36:18,280 --> 02:36:18,600 INDICATION. 3312 02:36:18,600 --> 02:36:21,280 BUT THE PERSON OR PERSONS IN THE 3313 02:36:21,280 --> 02:36:23,720 TRIAL ARE BENEFITTING FROM IT. 3314 02:36:23,720 --> 02:36:24,720 IS THERE ANY WAY THAT THOSE 3315 02:36:24,720 --> 02:36:31,480 KINDS OF CARE WOULD BE COVERED? 3316 02:36:31,480 --> 02:36:37,240 >> AGAIN I GUESS YOU ASK A VERY 3317 02:36:37,240 --> 02:36:38,000 COMPLEX QUESTION. 3318 02:36:38,000 --> 02:36:40,640 DEPENDS ON THE FACTS OF THE 3319 02:36:40,640 --> 02:36:42,640 MATTER. 3320 02:36:42,640 --> 02:36:44,760 BUT WHAT WE DEFINE AS PROVIDING 3321 02:36:44,760 --> 02:36:45,840 PATIENTS THE BENEFITS OF PATIENT 3322 02:36:45,840 --> 02:36:47,560 WOULD HAVE TO BE BASED ON THE 3323 02:36:47,560 --> 02:36:47,840 EVIDENCE. 3324 02:36:47,840 --> 02:36:49,480 BASED ON THE RESULTS OF THE 3325 02:36:49,480 --> 02:36:50,680 CLINICAL TRIAL. 3326 02:36:50,680 --> 02:36:52,880 IT'S NOT JUST THAT IT BENEFITS 3327 02:36:52,880 --> 02:36:53,360 THAT PATIENT. 3328 02:36:53,360 --> 02:36:55,040 ALL OF THOSE PATIENTS. 3329 02:36:55,040 --> 02:36:55,920 FOR THAT INDICATION THAT HAS 3330 02:36:55,920 --> 02:36:59,200 BEEN TESTED FOR. 3331 02:36:59,200 --> 02:37:00,520 AND SO YOU SAID IT'S SOMETHING 3332 02:37:00,520 --> 02:37:02,560 THAT'S BEING PURSUED FOR THAT 3333 02:37:02,560 --> 02:37:05,440 INDICATION NOT BEING PURSUED 3334 02:37:05,440 --> 02:37:07,360 BEING PURSUED FOR THAT 3335 02:37:07,360 --> 02:37:07,680 INDICATION. 3336 02:37:07,680 --> 02:37:09,960 NOT THAT THERE'S A WRINKLE IN 3337 02:37:09,960 --> 02:37:10,240 IT. 3338 02:37:10,240 --> 02:37:11,960 OUR NATIONAL DETERMINATION OF 3339 02:37:11,960 --> 02:37:15,120 COVERAGE WHETHER IT'S UNDER CDC 3340 02:37:15,120 --> 02:37:17,040 AND IF IT'S A TEST TYPICALLY IF 3341 02:37:17,040 --> 02:37:19,000 IT'S AN FDA APPROVED PRODUCT 3342 02:37:19,000 --> 02:37:20,400 WE'RE TESTING LOOKING AT THE 3343 02:37:20,400 --> 02:37:21,960 EVIDENCE FOR THAT INDICATION. 3344 02:37:21,960 --> 02:37:25,480 WE'RE TALKING ABOUT OFF LABEL 3345 02:37:25,480 --> 02:37:27,320 INDICATIONS THAT IT'S DIFFICULT 3346 02:37:27,320 --> 02:37:30,200 TO ANSWER WITHOUT LOOKING AT THE 3347 02:37:30,200 --> 02:37:31,520 FACTS OF THE MATTER. 3348 02:37:31,520 --> 02:37:33,800 >> CAN I ASK ONE OTHER WRINKLE 3349 02:37:33,800 --> 02:37:34,960 ON THAT. 3350 02:37:34,960 --> 02:37:36,160 BETWEEN THE TIME A TRIAL LET'S 3351 02:37:36,160 --> 02:37:39,400 SAY A TRIAL IS NOT UNDER CED BUT 3352 02:37:39,400 --> 02:37:42,840 IT'S ENDING TAKES A WHILE FOR 3353 02:37:42,840 --> 02:37:44,240 FDA APPROVAL, IS THERE ANY 3354 02:37:44,240 --> 02:37:48,000 BRIDGE IN THAT INTERSPACE? 3355 02:37:48,000 --> 02:37:49,480 >> I WOULD SAY IF WE'RE 3356 02:37:49,480 --> 02:37:50,920 COVERING ON THE FRONT END. 3357 02:37:50,920 --> 02:37:54,120 DEPENDS ON THE FACTS OF THE 3358 02:37:54,120 --> 02:37:55,480 MATTER. 3359 02:37:55,480 --> 02:37:58,160 BUT ACTUALLY WE USUALLY LOOK AT 3360 02:37:58,160 --> 02:38:00,280 FDA APPROVED DEVICES. 3361 02:38:00,280 --> 02:38:01,520 SO THEY'RE APPROVED ALREADY 3362 02:38:01,520 --> 02:38:01,840 THEORETICALLY. 3363 02:38:01,840 --> 02:38:03,640 BUT TO YOUR QUESTION, IF THE 3364 02:38:03,640 --> 02:38:05,840 TRIAL HAS ENDED IS NOT IN THE 3365 02:38:05,840 --> 02:38:09,080 CED AND IT TAKES A WHILE FOR US 3366 02:38:09,080 --> 02:38:12,280 TO APPROVE, DO WHAT'S CALLED 3367 02:38:12,280 --> 02:38:12,920 RECONSIDERATION LATER, BUT 3368 02:38:12,920 --> 02:38:14,400 THERE'S -- IF WE HAVE ALREADY 3369 02:38:14,400 --> 02:38:19,200 APPROVED IT UNDER THE CED WE 3370 02:38:19,200 --> 02:38:19,920 WILL STILL CONTINUE TO COVER IT 3371 02:38:19,920 --> 02:38:21,840 IN THE FUTURE. 3372 02:38:21,840 --> 02:38:23,360 THAT IS IT DEPENDS ON WHAT IS 3373 02:38:23,360 --> 02:38:24,800 THE STATUS OF THE DEVICE IN 3374 02:38:24,800 --> 02:38:26,480 TERMS OF APPROVAL FROM OUR END 3375 02:38:26,480 --> 02:38:27,720 AT THE TIME IT'S IMPLANTED AND 3376 02:38:27,720 --> 02:38:28,880 MAY NOT CHANGE AFTER THAT. 3377 02:38:28,880 --> 02:38:32,880 UNTIL WE RECONSIDER THE WHOLE 3378 02:38:32,880 --> 02:38:33,080 ISSUE. 3379 02:38:33,080 --> 02:38:37,120 THAT'S A SHORT AND DIRTY ANSWER. 3380 02:38:37,120 --> 02:38:37,480 OKAY. 3381 02:38:37,480 --> 02:38:38,320 >> THAT'S GREAT. 3382 02:38:38,320 --> 02:38:40,440 IF YOU DON'T MIND HOLDING YOUR 3383 02:38:40,440 --> 02:38:43,480 QUESTION IN WORKING MEMORY FOR A 3384 02:38:43,480 --> 02:38:45,040 LITTLE BIT LONGER. 3385 02:38:45,040 --> 02:38:46,080 WE'VE GOT THREE MORE 3386 02:38:46,080 --> 02:38:47,480 PRESENTATIONS HALFWAY THROUGH 3387 02:38:47,480 --> 02:38:48,720 THE PRESENTATIONS WE HAVE 3388 02:38:48,720 --> 02:38:50,640 45 MINUTES SCHEDULED AFTER THIS 3389 02:38:50,640 --> 02:38:51,560 FOR PANEL DISCUSSION. 3390 02:38:51,560 --> 02:38:52,800 IT WILL BE AN EXERCISE IN 3391 02:38:52,800 --> 02:38:55,480 WORKING MEMORY FOR ALL OF US 3392 02:38:55,480 --> 02:38:56,440 BECAUSE A LOT OF BALLS TO KEEP 3393 02:38:56,440 --> 02:39:00,360 UP IN THE AIR IN ORDER TO HAVE A 3394 02:39:00,360 --> 02:39:01,000 FULFILLING AND THOROUGH 3395 02:39:01,000 --> 02:39:03,520 DISCUSSION AT THE END OF THIS. 3396 02:39:03,520 --> 02:39:08,920 I'D LOVE TO INTRODUCE NOW OUR 3397 02:39:08,920 --> 02:39:11,320 NEXT SPEAKER, DR. ROBINSON 3398 02:39:11,320 --> 02:39:11,640 BEALE. 3399 02:39:11,640 --> 02:39:13,400 DR. RHONDA ROBINSON BEALE IS A 3400 02:39:13,400 --> 02:39:15,040 SENIOR HEALTHCARE EXECUTIVE 3401 02:39:15,040 --> 02:39:16,440 30 YEARS OF EXPERIENCE IN 3402 02:39:16,440 --> 02:39:18,520 HEALTHCARE SYSTEMS MANAGED CARE 3403 02:39:18,520 --> 02:39:19,720 QUALITY IMPROVEMENT BEHAVIORAL 3404 02:39:19,720 --> 02:39:21,720 HEALTH MEDICAL CARE. 3405 02:39:21,720 --> 02:39:23,960 SVP DEPUTY CHIEF MEDICAL OFFICER 3406 02:39:23,960 --> 02:39:25,960 FOR MENTAL HEALTH SERVICES FOR 3407 02:39:25,960 --> 02:39:27,320 UNITED HEALTH GROUP PREVIOUSLY 3408 02:39:27,320 --> 02:39:28,880 SERVED AS CHIEF MEDICAL OFFICER 3409 02:39:28,880 --> 02:39:30,440 AND PHYSICIAN EXECUTIVE WITHIN 3410 02:39:30,440 --> 02:39:33,600 SEVERAL LARGE NATIONAL AND LOCAL 3411 02:39:33,600 --> 02:39:36,880 HEALTH ORGANIZATIONS. 3412 02:39:36,880 --> 02:39:42,000 OPTUM SUB SUBSIDIARY OF UNITED, 3413 02:39:42,000 --> 02:39:45,160 SIGNA AND BLUE CROSS/BLUE SHIELD 3414 02:39:45,160 --> 02:39:48,920 MICHIGAN AND HEALTH BLINDS IN 3415 02:39:48,920 --> 02:39:49,520 MICHIGAN. 3416 02:39:49,520 --> 02:39:53,360 WELCOME DR. BEALE. 3417 02:39:53,360 --> 02:40:01,480 WOULD YOU MIND UNMUTING, PLEASE. 3418 02:40:01,480 --> 02:40:03,440 >> IF YOU'RE ON A PHONE UNMUTE 3419 02:40:03,440 --> 02:40:13,720 BY HITTING STAR 6. 3420 02:40:17,000 --> 02:40:17,440 >> HELLO. 3421 02:40:17,440 --> 02:40:18,320 >> THERE YOU ARE. 3422 02:40:18,320 --> 02:40:21,960 >> THAT'S BETTER NOW, I THINK. 3423 02:40:21,960 --> 02:40:22,200 >> OKAY. 3424 02:40:22,200 --> 02:40:24,920 ALL RIGHT. 3425 02:40:24,920 --> 02:40:27,480 [INAUDIBLE] THE CHALLENGES I'VE 3426 02:40:27,480 --> 02:40:28,120 HAD TODAY. 3427 02:40:28,120 --> 02:40:30,400 AND FIRST OF ALL, I WANT TO 3428 02:40:30,400 --> 02:40:34,520 THANK YOU FOR THE OPPORTUNITY TO 3429 02:40:34,520 --> 02:40:36,800 BE HERE FOR THIS IMPORTANT 3430 02:40:36,800 --> 02:40:37,040 SUBJECT. 3431 02:40:37,040 --> 02:40:39,240 AND IT'S CERTAINLY ONES THAT ALL 3432 02:40:39,240 --> 02:40:42,600 THE OTHER PREVIOUS PANELIST 3433 02:40:42,600 --> 02:40:46,560 [INAUDIBLE] BEING COMPLEX AND 3434 02:40:46,560 --> 02:40:46,920 MULTIFACTORIAL. 3435 02:40:46,920 --> 02:40:48,280 AND [INAUDIBLE] VERY, VERY 3436 02:40:48,280 --> 02:40:50,160 COMPLEX AND IF IT WAS SIMPLE TO 3437 02:40:50,160 --> 02:40:51,800 RESOLVE, IT WOULD HAVE BEEN 3438 02:40:51,800 --> 02:40:52,840 RESOLVED BY NOW. 3439 02:40:52,840 --> 02:40:55,520 I DO THINK THAT HAVING THIS KIND 3440 02:40:55,520 --> 02:40:58,760 OF CONVERSATION WITH 3441 02:40:58,760 --> 02:40:59,960 MULTISTAKEHOLDERS AND 3442 02:40:59,960 --> 02:41:02,680 [INAUDIBLE] CAN HELP GET 3443 02:41:02,680 --> 02:41:05,360 [INAUDIBLE] TO A SOLUTION OR A 3444 02:41:05,360 --> 02:41:06,960 DIRECTION OF SOLUTIONS. 3445 02:41:06,960 --> 02:41:08,680 I AM NOT ABLE TO SHARE MY SLIDES 3446 02:41:08,680 --> 02:41:12,280 WITH YOU GUYS SO I WILL TALK 3447 02:41:12,280 --> 02:41:13,680 FROM THEM. 3448 02:41:13,680 --> 02:41:18,160 AND TO TALK ABOUT A PAYER'S 3449 02:41:18,160 --> 02:41:18,560 PERSPECTIVE. 3450 02:41:18,560 --> 02:41:21,080 FIRST OF ALL, TO SAY THAT MY 3451 02:41:21,080 --> 02:41:23,080 COMMENTS THAT I'M GOING TO 3452 02:41:23,080 --> 02:41:25,720 PRESENT ARE NOT MEANT TO BE A 3453 02:41:25,720 --> 02:41:27,400 REPRESENTATIVE OF ANY ONE HEALTH 3454 02:41:27,400 --> 02:41:28,920 INSURANCE COMPANY. 3455 02:41:28,920 --> 02:41:31,200 I'M REALLY BRINGING THE 3456 02:41:31,200 --> 02:41:34,480 EXPERIENCE [INAUDIBLE] TO 3457 02:41:34,480 --> 02:41:39,200 INCLUDING UNITED BUT OTHERS IN 3458 02:41:39,200 --> 02:41:41,000 TERMS OF [INAUDIBLE] HOW THEY'VE 3459 02:41:41,000 --> 02:41:41,560 ADDRESSED THIS PARTICULAR 3460 02:41:41,560 --> 02:41:47,640 SUBJECT. 3461 02:41:47,640 --> 02:41:48,520 LET'S OVERALL TALK ABOUT 3462 02:41:48,520 --> 02:41:49,880 INSURANCE [INAUDIBLE] 3463 02:41:49,880 --> 02:41:50,880 [INAUDIBLE] LEVEL SETTING HERE 3464 02:41:50,880 --> 02:41:56,240 TO MAKE SURE THAT WE'RE ALL 3465 02:41:56,240 --> 02:41:56,560 [INAUDIBLE]. 3466 02:41:56,560 --> 02:41:58,240 >> EVERY FIFTH WORD OR SO IS 3467 02:41:58,240 --> 02:41:58,960 DROPPING OUT. 3468 02:41:58,960 --> 02:42:01,360 I WONDER IF THERE'S A WAY TO GET 3469 02:42:01,360 --> 02:42:02,680 THE MIC CLOSER. 3470 02:42:02,680 --> 02:42:04,600 >> ALL RIGHT. 3471 02:42:04,600 --> 02:42:04,960 IS THIS BETTER? 3472 02:42:04,960 --> 02:42:06,200 >> I THINK SO. 3473 02:42:06,200 --> 02:42:07,880 THANK YOU. 3474 02:42:07,880 --> 02:42:08,680 SORRY. 3475 02:42:08,680 --> 02:42:10,520 >> OKAY. 3476 02:42:10,520 --> 02:42:11,760 SORRY. 3477 02:42:11,760 --> 02:42:15,440 SO [INAUDIBLE] HEALTHCARE 3478 02:42:15,440 --> 02:42:17,000 INNOVATION DIAGNOSTICS 3479 02:42:17,000 --> 02:42:20,440 [INAUDIBLE] MUST BE SUFFICIENTLY 3480 02:42:20,440 --> 02:42:23,880 AND CONSISTENTLY [INAUDIBLE] TO 3481 02:42:23,880 --> 02:42:27,800 BE IMPACTFUL WITH PATIENT -- 3482 02:42:27,800 --> 02:42:29,720 THAT'S KIND OF THE BOTTOM IN 3483 02:42:29,720 --> 02:42:32,920 TERMS OF THE THRESHOLD THAT 3484 02:42:32,920 --> 02:42:38,400 NEEDS TO BE [INAUDIBLE] 3485 02:42:38,400 --> 02:42:40,880 COVERAGE. 3486 02:42:40,880 --> 02:42:44,000 INSURANCE [INAUDIBLE] THEN 3487 02:42:44,000 --> 02:42:47,120 BENEFIT COVERAGE. 3488 02:42:47,120 --> 02:42:49,480 [INAUDIBLE] TO INSURANCE 3489 02:42:49,480 --> 02:42:52,600 DIFFERENT PAYERS CAN HAVE 3490 02:42:52,600 --> 02:42:55,880 DIFFERENT PATHS AS TO WHEN AND 3491 02:42:55,880 --> 02:42:58,960 WHAT THEY WILL COVER OF THOSE 3492 02:42:58,960 --> 02:42:59,880 TECHNOLOGIES EVEN THOUGH THEY 3493 02:42:59,880 --> 02:43:01,720 ARE PROVEN AND EVEN THOUGH 3494 02:43:01,720 --> 02:43:07,520 THEY'RE FDA APPROVED. 3495 02:43:07,520 --> 02:43:11,520 KEEP IN MIND [INAUDIBLE] 3496 02:43:11,520 --> 02:43:12,200 >> DR. ROBINSON BEALE, I'M 3497 02:43:12,200 --> 02:43:13,520 SORRY, WONDER IF THERE'S A 3498 02:43:13,520 --> 02:43:15,200 DIFFERENT WAY TO CONNECT YOUR 3499 02:43:15,200 --> 02:43:15,400 AUDIO. 3500 02:43:15,400 --> 02:43:19,320 SEVERAL OF US ARE STILL GETTING 3501 02:43:19,320 --> 02:43:25,160 AUDIO DROPOUT. 3502 02:43:25,160 --> 02:43:28,480 >> ARE YOU ABLE TO USE AUDIO ON 3503 02:43:28,480 --> 02:43:29,560 YOUR COMPUTER, LOOKS LIKE YOU 3504 02:43:29,560 --> 02:43:31,480 WEREN'T ABLE TO EARLIER THAT'S 3505 02:43:31,480 --> 02:43:34,920 WHY YOU'RE ON YOUR PHONE. 3506 02:43:34,920 --> 02:43:38,200 >> THAT'S WHY I CAN'T SEE THE 3507 02:43:38,200 --> 02:43:41,960 ICON I TRIED SEVERAL THINGS AS I 3508 02:43:41,960 --> 02:43:44,960 WAS SITTING [INAUDIBLE] WOULD 3509 02:43:44,960 --> 02:43:47,160 YOU WANT TO GO ON WITH THE 3510 02:43:47,160 --> 02:43:48,880 DIFFERENT SPEAKER UNTIL I GET A 3511 02:43:48,880 --> 02:43:50,440 DIFFERENT MECHANISM FOR THIS? 3512 02:43:50,440 --> 02:43:52,440 >> I THINK THAT'S A GOOD IDEA. 3513 02:43:52,440 --> 02:43:54,200 IF YOU DON'T MIND SORRY TO 3514 02:43:54,200 --> 02:43:55,080 INCONVENIENCE YOU MAYBE WE CAN 3515 02:43:55,080 --> 02:43:57,880 TRY THAT SEE IN THE MEANWHILE IF 3516 02:43:57,880 --> 02:43:58,880 WE CAN WORK BACK TO SOME OF THE 3517 02:43:58,880 --> 02:44:09,240 OTHER AUDIO OPTIONS. 3518 02:44:11,400 --> 02:44:12,560 >> I'LL REACH BACK OUT TO YOU. 3519 02:44:12,560 --> 02:44:13,360 >> THANK YOU. 3520 02:44:13,360 --> 02:44:15,320 >> WE'LL MOVE FORWARD TO THE 3521 02:44:15,320 --> 02:44:19,040 NEXT PANEL SPEAKER AS WE WORK 3522 02:44:19,040 --> 02:44:20,720 WITH THE TECH ISSUES WITH DR. 3523 02:44:20,720 --> 02:44:21,080 ROBINSON BEALE. 3524 02:44:21,080 --> 02:44:23,000 WITH THAT I'LL INTRODUCE SHIRLEY 3525 02:44:23,000 --> 02:44:26,400 MCCARTNEY SERVES AS DIRECTOR OF 3526 02:44:26,400 --> 02:44:28,080 NEUROLOGICAL SURGERY RESEARCH 3527 02:44:28,080 --> 02:44:30,240 FOR BOTH CLINICAL TRIALS AND 3528 02:44:30,240 --> 02:44:30,880 INVESTIGATOR INITIATIVE CLINICAL 3529 02:44:30,880 --> 02:44:32,440 RESEARCH IN THE SCHOOL OF 3530 02:44:32,440 --> 02:44:34,720 MEDICINE AT OREGON HEALTH AND 3531 02:44:34,720 --> 02:44:35,480 SCIENCE UNIVERSITY. 3532 02:44:35,480 --> 02:44:36,760 THE RESPONSIBILITIES INCLUDE 3533 02:44:36,760 --> 02:44:38,080 TEACHING AND DIRECTING FACULTY 3534 02:44:38,080 --> 02:44:40,720 AND STAFF OF THE DEPARTMENT OF 3535 02:44:40,720 --> 02:44:43,920 NEUROLOGICAL SURGERY ON OHSU 3536 02:44:43,920 --> 02:44:44,960 INSTITUTIONAL REVIEW BOARD 3537 02:44:44,960 --> 02:44:46,560 POLICIES, CLINICAL TRIAL 3538 02:44:46,560 --> 02:44:48,920 MANAGEMENT AND ACADEMIC 3539 02:44:48,920 --> 02:44:49,960 PUBLISHING ETHICS. 3540 02:44:49,960 --> 02:44:52,920 DR. MCCARTNEY. 3541 02:44:52,920 --> 02:44:53,360 >> GOOD AFTERNOON. 3542 02:44:53,360 --> 02:44:54,400 CAN YOU HEAR ME? 3543 02:44:54,400 --> 02:44:56,200 >> YES, WE CAN HEAR YOU. 3544 02:44:56,200 --> 02:44:56,880 >> THANK YOU. 3545 02:44:56,880 --> 02:44:59,080 I THINK I MENTIONED EARLIER I 3546 02:44:59,080 --> 02:45:04,880 HAVE A DEMENTED HEADSET. 3547 02:45:04,880 --> 02:45:07,840 I WOULD MOVE YOU ALL IN FRONT OF 3548 02:45:07,840 --> 02:45:08,440 MY NOTES. 3549 02:45:08,440 --> 02:45:09,440 I'LL MOVE YOU ALL. 3550 02:45:09,440 --> 02:45:12,680 I'D LIKE TO BEGIN THAT THE LAND 3551 02:45:12,680 --> 02:45:15,720 FOR OREGON HEALTH SCIENCE RESTS 3552 02:45:15,720 --> 02:45:19,520 ON THE TRADITIONAL VILLAGE SITES 3553 02:45:19,520 --> 02:45:26,560 OF THE CHINOOK AND OTHER TRIBES 3554 02:45:26,560 --> 02:45:28,720 WHO MADE THEIR HOMES AND FORMED 3555 02:45:28,720 --> 02:45:29,880 COMMUNITIES ALONG THE COLUMBIA 3556 02:45:29,880 --> 02:45:30,080 RIVER. 3557 02:45:30,080 --> 02:45:31,800 I'D LIKE TO YOU JOIN ME IN 3558 02:45:31,800 --> 02:45:35,440 TAKING THIS OPPORTUNITY TO PAY 3559 02:45:35,440 --> 02:45:37,480 RESPECT HONOR AND THANK PAST, 3560 02:45:37,480 --> 02:45:39,040 PRESENT AND FUTURE TRIBAL 3561 02:45:39,040 --> 02:45:40,920 GENERATIONS FOR THEIR SACRIFICE 3562 02:45:40,920 --> 02:45:43,120 AND CARE OF THE LAND. 3563 02:45:43,120 --> 02:45:45,040 I DO NOT HAVE ANY DISCLOSURES. 3564 02:45:45,040 --> 02:45:46,280 MY THOUGHTS AND COMMENTS TODAY 3565 02:45:46,280 --> 02:45:47,560 ARE MY OWN. 3566 02:45:47,560 --> 02:45:49,920 I DO NOT REPRESENT THOSE OF 3567 02:45:49,920 --> 02:45:52,040 OREGON HEALTH AND SCIENCE 3568 02:45:52,040 --> 02:45:52,320 UNIVERSITY. 3569 02:45:52,320 --> 02:45:53,920 I TRULY APPRECIATE HEARING FROM 3570 02:45:53,920 --> 02:45:54,760 THE PARTICIPANTS THIS MORNING, 3571 02:45:54,760 --> 02:45:57,880 IT WAS VERY INFORMATIVE AND VERY 3572 02:45:57,880 --> 02:45:58,320 HUMBLING. 3573 02:45:58,320 --> 02:46:00,880 AS WE HEARD EARLIER TODAY, WHAT 3574 02:46:00,880 --> 02:46:03,240 IS THE BOUNDARY BETWEEN RESEARCH 3575 02:46:03,240 --> 02:46:04,520 AND CLINICAL CARE? 3576 02:46:04,520 --> 02:46:07,480 AND AT A PREVIOUS MEETING, FOUR 3577 02:46:07,480 --> 02:46:09,360 TOPICS WERE HIGHLIGHTED FOR 3578 02:46:09,360 --> 02:46:10,440 DISCUSSION AROUND POST-TRIAL 3579 02:46:10,440 --> 02:46:11,440 CARE. 3580 02:46:11,440 --> 02:46:12,880 AND I'M GOING TO FOCUS MY 3581 02:46:12,880 --> 02:46:14,680 DISCUSSION WITH YOU ON THOSE 3582 02:46:14,680 --> 02:46:16,080 FOUR TOPICS. 3583 02:46:16,080 --> 02:46:16,960 MINIMUM CARE. 3584 02:46:16,960 --> 02:46:19,440 SETTING EXPECTATIONS, FACTORS 3585 02:46:19,440 --> 02:46:20,880 THAT IMPACT CARE AND COVERAGE 3586 02:46:20,880 --> 02:46:23,320 AND GAPS IN CARE. 3587 02:46:23,320 --> 02:46:25,960 SO NEXT SLIDE. 3588 02:46:25,960 --> 02:46:26,400 MINIMUM CARE. 3589 02:46:26,400 --> 02:46:28,800 WHILST TRIAL CARE IS A DIFFICULT 3590 02:46:28,800 --> 02:46:30,960 DEFINITION AND CAN BE CONFUSING 3591 02:46:30,960 --> 02:46:32,520 TO PATIENTS, WE HAVE HAD 3592 02:46:32,520 --> 02:46:34,640 STANDARD OF CARE PATIENTS CALL 3593 02:46:34,640 --> 02:46:36,880 OUR CLINK THINKING THEY'RE IN A 3594 02:46:36,880 --> 02:46:38,000 CLINICAL TRIAL WHEN IN FACT 3595 02:46:38,000 --> 02:46:39,760 THEY'RE NOT. 3596 02:46:39,760 --> 02:46:41,120 MANY INSTITUTIONS IMPLANT 3597 02:46:41,120 --> 02:46:43,640 DEVICES WITH THE TRIAL OF THE 3598 02:46:43,640 --> 02:46:46,560 DEVICE TO DETERMINE EFFICACY 3599 02:46:46,560 --> 02:46:47,440 BEFORE PERMANENT DEVICE 3600 02:46:47,440 --> 02:46:49,160 IMPLANTATION, AS IS THE CASE FOR 3601 02:46:49,160 --> 02:46:50,400 SPINAL CORD STIMULATION. 3602 02:46:50,400 --> 02:46:54,680 AND IT'S WORTH REMEMBERING THAT 3603 02:46:54,680 --> 02:46:56,920 MANY INSTITUTIONS PROVIDE 3604 02:46:56,920 --> 02:46:58,960 STATE-OF-THE-ART POST IMPLANT 3605 02:46:58,960 --> 02:47:00,240 DEVICE TRIAL CARE ALREADY FOR 3606 02:47:00,240 --> 02:47:01,520 DEVICES THAT ARE APPROVED. 3607 02:47:01,520 --> 02:47:05,880 AND ADDED TO THAT, MANUFACTURER 3608 02:47:05,880 --> 02:47:06,680 REPRESENTATIVETIVES ARE OFTEN 3609 02:47:06,680 --> 02:47:08,880 INVOLVED AND PLAY A PIVOTAL ROLE 3610 02:47:08,880 --> 02:47:10,360 IN STANDARD OF CARE. 3611 02:47:10,360 --> 02:47:14,240 THE QUESTION IS, DID THE DEVICE 3612 02:47:14,240 --> 02:47:16,560 RECEIVE FDA APPROVAL, YES OR NO. 3613 02:47:16,560 --> 02:47:18,960 AND THIS ANSWER LIKELY DICTATES 3614 02:47:18,960 --> 02:47:21,240 TWO POTENTIAL PATHS FOR MINIMUM 3615 02:47:21,240 --> 02:47:22,080 OF CARE. 3616 02:47:22,080 --> 02:47:22,880 PATH ONE. 3617 02:47:22,880 --> 02:47:25,480 A DEVICE IS APPROVED AND WILL BE 3618 02:47:25,480 --> 02:47:27,080 USED COMMERCIALLY. 3619 02:47:27,080 --> 02:47:29,680 WAS THERE A PREDETERMINED 3620 02:47:29,680 --> 02:47:30,760 THRESHOLD ACROSS STUDIES THAT 3621 02:47:30,760 --> 02:47:32,240 DETERMINED BENEFIT? 3622 02:47:32,240 --> 02:47:34,040 BENEFIT IN TERMS OF CARE? 3623 02:47:34,040 --> 02:47:36,920 WHAT DOES CARE EXTEND TO IN THIS 3624 02:47:36,920 --> 02:47:37,920 INSTANCE? 3625 02:47:37,920 --> 02:47:40,760 A CLEAR UNDERSTANDING OF BENEFIT 3626 02:47:40,760 --> 02:47:43,480 TO THE PATIENTS DOES THIS 3627 02:47:43,480 --> 02:47:46,320 INCLUDE CLINICAL BENEFIT ONLY? 3628 02:47:46,320 --> 02:47:49,320 IS THE DEVICE PROVIDING CLINICAL 3629 02:47:49,320 --> 02:47:50,400 MEASURABLE BENEFIT TO PATIENTS 3630 02:47:50,400 --> 02:47:53,240 AND IS THE DEVICE ALSO APPROVED 3631 02:47:53,240 --> 02:47:54,880 FOR USE MEDICARE MEDICAID 3632 02:47:54,880 --> 02:47:56,680 SERVICES JUST AS WE HEARD. 3633 02:47:56,680 --> 02:47:59,400 AND IS THERE ACCESS TO DATA 3634 02:47:59,400 --> 02:48:00,320 GENERATED DURING THE CLINICAL 3635 02:48:00,320 --> 02:48:01,760 TRIAL PATIENTS PERSONAL DATA AND 3636 02:48:01,760 --> 02:48:03,960 GLOBAL DATA AGAIN WE HEARD THAT 3637 02:48:03,960 --> 02:48:05,720 EARLIER THIS MORNING. 3638 02:48:05,720 --> 02:48:07,440 AND WAS THERE SUFFICIENT TIME 3639 02:48:07,440 --> 02:48:09,960 FOR THE PATIENT TO DECIDE IF HE 3640 02:48:09,960 --> 02:48:11,280 WISHED TO TRANSITION TO 3641 02:48:11,280 --> 02:48:14,200 COMMERCIAL USE OR NOT, THAT IS 3642 02:48:14,200 --> 02:48:15,520 TO INSTITUTIONAL STANDARD OF 3643 02:48:15,520 --> 02:48:17,640 CARE PROTONS, EVEN IF THOSE ARE 3644 02:48:17,640 --> 02:48:17,920 AVAILABLE. 3645 02:48:17,920 --> 02:48:23,680 AND I JUST WANT US TO NOT FORGET 3646 02:48:23,680 --> 02:48:27,760 AND CONTINUE TO REMEMBER 3647 02:48:27,760 --> 02:48:28,440 PATIENTS THEMSELVES PROVIDE THE 3648 02:48:28,440 --> 02:48:29,760 DATA THAT IS NEEDED FOR THE 3649 02:48:29,760 --> 02:48:31,040 DEVICE APPROVAL. 3650 02:48:31,040 --> 02:48:32,560 ETHICALLY, WHO IS REALLY 3651 02:48:32,560 --> 02:48:34,720 RESPONSIBLE FOR CONTINUATION OF 3652 02:48:34,720 --> 02:48:36,920 CARE IN THIS INSTANCE? 3653 02:48:36,920 --> 02:48:39,240 AND PATH TWO, A DEVICE IS NOT 3654 02:48:39,240 --> 02:48:39,520 APPROVED. 3655 02:48:39,520 --> 02:48:41,480 IF NOT APPROVED, IS THERE AN 3656 02:48:41,480 --> 02:48:44,880 AVENUE FOR CONTINUED ACCESS TO 3657 02:48:44,880 --> 02:48:47,480 AN INVESTIGATIONAL DEVICE 3658 02:48:47,480 --> 02:48:49,520 IF IN A CASE WHERE THERE IS 3659 02:48:49,520 --> 02:48:54,720 CLINICAL BENEFIT TO THE PATIENT? 3660 02:48:54,720 --> 02:48:58,200 DID THE STUDY INCLUDE COST OF 3661 02:48:58,200 --> 02:48:59,920 APPROVAL REPLACEMENT REACHING 3662 02:48:59,920 --> 02:49:01,360 END OF LIFE AND ALTERNATE 3663 02:49:01,360 --> 02:49:02,640 RESOURCES THAT WERE NOT RELATED 3664 02:49:02,640 --> 02:49:04,000 TO THE DEVICE? 3665 02:49:04,000 --> 02:49:07,080 WHAT IF THE SPONSOR DECIDES NOT 3666 02:49:07,080 --> 02:49:08,440 TO PURSUE FURTHER RESEARCH 3667 02:49:08,440 --> 02:49:09,360 AND/OR DEVICE APPROVAL AFTER 3668 02:49:09,360 --> 02:49:11,880 STUDY END, WHAT THEN IS THE 3669 02:49:11,880 --> 02:49:12,320 SPONSORS ROLE? 3670 02:49:12,320 --> 02:49:14,720 AND ONCE AGAIN ETHICALLY WHO IS 3671 02:49:14,720 --> 02:49:16,440 RESPONSIBLE FOR THE CARE OF WHAT 3672 02:49:16,440 --> 02:49:17,960 COULD NOW BE REFERRED TO AS A 3673 02:49:17,960 --> 02:49:23,400 TRIAL ABANDONED PATIENT? 3674 02:49:23,400 --> 02:49:26,800 AS ENDORSED HERE WE ALL AGREE 3675 02:49:26,800 --> 02:49:28,880 MAINTAINING COORDINATION OF CARE 3676 02:49:28,880 --> 02:49:32,640 IS CRITICAL FOR STUDY PATIENTS 3677 02:49:32,640 --> 02:49:34,360 LEAVING A DEVICE TRIAL. 3678 02:49:34,360 --> 02:49:35,160 NEXT SLIDE. 3679 02:49:35,160 --> 02:49:36,880 SETTING EXPECTATIONS FOR ME 3680 02:49:36,880 --> 02:49:40,280 PERSONALLY THIS COMES DOWN TO 3681 02:49:40,280 --> 02:49:41,960 THREE QUESTIONS, EDUCATION AND 3682 02:49:41,960 --> 02:49:43,520 TRUST COMMUNICATION AND 3683 02:49:43,520 --> 02:49:45,000 NAVIGATION OF THE HEALTHCARE 3684 02:49:45,000 --> 02:49:46,840 SYSTEM ITSELF. 3685 02:49:46,840 --> 02:49:49,320 TIME SPENT WITH SUBJECTS IN A 3686 02:49:49,320 --> 02:49:56,800 CLINICAL STUDY CAN BE LONG AND 3687 02:49:56,800 --> 02:49:58,120 THERE ARE LONG REPEATED VISITS, 3688 02:49:58,120 --> 02:49:59,800 VISITS MAY LAST FOR YEARS AND 3689 02:49:59,800 --> 02:50:00,560 RELATIONSHIP IS BUILT WITH THE 3690 02:50:00,560 --> 02:50:04,120 STUDY TEAM AND THE PRINCIPAL 3691 02:50:04,120 --> 02:50:04,440 INVESTIGATOR. 3692 02:50:04,440 --> 02:50:05,280 AND SINCE THAT RELATIONSHIP 3693 02:50:05,280 --> 02:50:07,240 DEVELOPS OVER TIME, I WONDER IF 3694 02:50:07,240 --> 02:50:08,880 THERE'S AN OPPORTUNITY IN THE 3695 02:50:08,880 --> 02:50:11,680 INFORMED CONSENT PROCESS TO WORK 3696 02:50:11,680 --> 02:50:15,720 ON LANGUAGE, LANGUAGE THAT SETS 3697 02:50:15,720 --> 02:50:16,600 EXPECTATIONS RELATED TO 3698 02:50:16,600 --> 02:50:19,520 POST-TRIAL CARE, FINANCIAL COST 3699 02:50:19,520 --> 02:50:21,200 COULD BE ESTABLISHED DURING 3700 02:50:21,200 --> 02:50:22,520 RECRUITMENT AND INFORMED CONSENT 3701 02:50:22,520 --> 02:50:24,920 PROCESS, LONG BEFORE THE TRIAL 3702 02:50:24,920 --> 02:50:26,200 IS EVEN COMPLETED. 3703 02:50:26,200 --> 02:50:28,880 FOR SOME CLINICAL TRIALS THE 3704 02:50:28,880 --> 02:50:30,080 INFORMED CONSENT PROCESS 3705 02:50:30,080 --> 02:50:30,760 INVOLVES PROVIDING THE PATIENTS 3706 02:50:30,760 --> 02:50:32,360 WITH FINANCIAL INFORMATION ABOUT 3707 02:50:32,360 --> 02:50:34,640 THE COST OF COVERAGE THROUGHOUT 3708 02:50:34,640 --> 02:50:36,640 THE TRIAL BUT NOT NECESSARILY 3709 02:50:36,640 --> 02:50:38,240 AFTER THE TRIAL HAS ENDED AND 3710 02:50:38,240 --> 02:50:40,440 WE'VE HEARD THAT ALREADY TODAY 3711 02:50:40,440 --> 02:50:40,640 ALSO. 3712 02:50:40,640 --> 02:50:43,520 WHAT I'M SUGGESTING IS TO 3713 02:50:43,520 --> 02:50:44,880 PROVIDE PATIENTS WITH 3714 02:50:44,880 --> 02:50:46,720 INFORMATION RELATED TO POSSIBLE 3715 02:50:46,720 --> 02:50:48,000 FINANCIAL BURDEN OR NOT THAT 3716 02:50:48,000 --> 02:50:51,240 MIGHT OCCUR AT A LATER DATE LONG 3717 02:50:51,240 --> 02:50:54,320 BEFORE THEY AGREE TO 3718 02:50:54,320 --> 02:50:54,640 PARTICIPATE. 3719 02:50:54,640 --> 02:50:56,160 HOWEVER, THAT BEING SAID, 3720 02:50:56,160 --> 02:50:57,160 FORECASTING THE POSSIBLE NEEDS 3721 02:50:57,160 --> 02:50:58,720 OF A PATIENT WITH A DEVICE SUCH 3722 02:50:58,720 --> 02:51:01,320 AS A BATTERY REPLACEMENT OR A 3723 02:51:01,320 --> 02:51:06,840 NEED 3724 02:51:06,840 --> 02:51:10,800 OR COMPATIBILITY AS WE HEARD 3725 02:51:10,800 --> 02:51:11,360 EARLIER TODAY CAN ALSO BE 3726 02:51:11,360 --> 02:51:12,880 DIFFICULT. 3727 02:51:12,880 --> 02:51:21,280 AND PATIENTS MAY STILL NEED 3728 02:51:21,280 --> 02:51:23,320 ADDITIONAL SURGERY. 3729 02:51:23,320 --> 02:51:27,720 WITH INPUT FROM SOME OF MY 3730 02:51:27,720 --> 02:51:28,920 NEUROSURGICAL COLLEAGUES. 3731 02:51:28,920 --> 02:51:31,440 HAVE TWO EXAMPLES OF TRIAL 3732 02:51:31,440 --> 02:51:33,320 PATIENTS, WHERE SETTING 3733 02:51:33,320 --> 02:51:34,360 EXPECTATIONS EARLY ON MAY HAVE 3734 02:51:34,360 --> 02:51:35,800 HELPED. 3735 02:51:35,800 --> 02:51:40,920 IN A STUDY FOR DEEP BRAIN 3736 02:51:40,920 --> 02:51:44,880 STIMULATION FOR DEPRESSION, 3737 02:51:44,880 --> 02:51:45,480 SPONSOR, PAYING FOR GENERATOR 3738 02:51:45,480 --> 02:51:46,120 REPLACEMENTS, AND THE PATIENTS 3739 02:51:46,120 --> 02:51:46,840 WERE LEFT WITH NO RECOURSE. 3740 02:51:46,840 --> 02:51:47,480 AFTER THE TRIAL WAS CLOSED AND 3741 02:51:47,480 --> 02:51:55,520 THE RENEWAL INSURANCE COVERAGE, 3742 02:51:55,520 --> 02:51:56,160 GANGLING STIMULATION PER CLUSTER 3743 02:51:56,160 --> 02:52:00,920 THE SPONSOR FILED FOR BANKRUPTCY 3744 02:52:00,920 --> 02:52:01,440 AND THE UNIVERSITY FOUND 3745 02:52:01,440 --> 02:52:02,040 THEMSELVES IN A POSITION THAT 3746 02:52:02,040 --> 02:52:02,680 THEY HAD TO FIND RESOURCES TO 3747 02:52:02,680 --> 02:52:03,280 COVER A IMPLEMENTATION OF THE 3748 02:52:03,280 --> 02:52:08,880 DEVICE. ETHICALLY, WHO'S 3749 02:52:08,880 --> 02:52:09,520 RESPONSIBLE FOR THE CONTINUATION 3750 02:52:09,520 --> 02:52:10,920 OF CARE, AND THE CONTINUATION OF 3751 02:52:10,920 --> 02:52:11,960 COVERING COST. 3752 02:52:11,960 --> 02:52:13,040 NEST SLIDE. 3753 02:52:13,040 --> 02:52:14,640 FACTORS THAT IMPACT COVERAGE. 3754 02:52:14,640 --> 02:52:17,440 THE HEALTH CARE SYSTEM ITSELF. 3755 02:52:17,440 --> 02:52:18,640 MEDICALLY UNDER SERVED 3756 02:52:18,640 --> 02:52:20,240 COMMUNITIES AND POPULATIONS JUST 3757 02:52:20,240 --> 02:52:22,560 GENERALLY DO NOT HAVE ACCESS. 3758 02:52:22,560 --> 02:52:22,960 TRUST. 3759 02:52:22,960 --> 02:52:26,800 IF THE PANDEMIC HAS TAUGHT US 3760 02:52:26,800 --> 02:52:28,480 ANYTHING, THAT IS THERE IS A 3761 02:52:28,480 --> 02:52:30,520 LACK OF TRUST IN MANY 3762 02:52:30,520 --> 02:52:31,720 COMMUNITIES RELATED TO HEALTH 3763 02:52:31,720 --> 02:52:34,720 CARE ISSUES. 3764 02:52:34,720 --> 02:52:37,360 STATE AND FEDERAL LIMITATIONS, 3765 02:52:37,360 --> 02:52:40,360 AND I HAVE TWO EXAMPLES, I CAN 3766 02:52:40,360 --> 02:52:46,000 TELL YOU THAT IN OREGON PSYCHO 3767 02:52:46,000 --> 02:52:49,440 SURGERY IS AMONG THE LIST OF 3768 02:52:49,440 --> 02:52:50,040 CONDUCT THAT IS GROUND FOR 3769 02:52:50,040 --> 02:52:52,400 DISCIPLINE. 3770 02:52:52,400 --> 02:52:55,040 PSYCHOSURGERY IS DEFINED AS ANY 3771 02:52:55,040 --> 02:52:59,760 OPERATION DESIGNED TO PRODUCE AN 3772 02:52:59,760 --> 02:53:00,400 IRREVERSIBLE LESION OR DESTROY 3773 02:53:00,400 --> 02:53:04,400 BRAIN TISSUE FOR THE PRIMARY 3774 02:53:04,400 --> 02:53:04,920 PURPOSE OF ALTERING THE 3775 02:53:04,920 --> 02:53:06,760 THOUGHTS, EMOTIONS, OR BEHAV 3776 02:53:06,760 --> 02:53:08,120 BEHAVIOROF A HUMAN BEING. 3777 02:53:08,120 --> 02:53:09,680 HOWEVER THE TERM DOES NOT 3778 02:53:09,680 --> 02:53:12,400 INCLUDE PROCEDURES UNDER TAKEN 3779 02:53:12,400 --> 02:53:17,720 TO CURE WELL DEFINED DISEASE 3780 02:53:17,720 --> 02:53:19,000 STATES, SUCH AS BRAIN TUMOR 3781 02:53:19,000 --> 02:53:19,600 EPILEPTIC FOCI AND CERTAIN 3782 02:53:19,600 --> 02:53:24,240 CHRONIC PAIN SYNDROMES.IN 3783 02:53:24,240 --> 02:53:28,640 ADDITION SHE NOTIC BRAIN SURGERY 3784 02:53:28,640 --> 02:53:29,160 FOR OTHER PURPOSES, ALSO 3785 02:53:29,160 --> 02:53:31,680 ACCEPTABLE. SO SOME OF YOU WHO 3786 02:53:31,680 --> 02:53:32,280 ARE IN THE PANEL THIS MORNING 3787 02:53:32,280 --> 02:53:32,920 WOULD NOT BE HAVE ACCESS TO THIS 3788 02:53:32,920 --> 02:53:38,720 PROCEDURE, IN OREGON. 3789 02:53:38,720 --> 02:53:48,360 HIGHLY EX-PER EXPERIENCEDED 3790 02:53:48,360 --> 02:53:51,720 TEAM PERFORMING THE FIRST DEEP 3791 02:53:51,720 --> 02:53:52,400 BRAIN SURGERY FOR PARKINSON'S 3792 02:53:52,400 --> 02:53:55,080 DISEASE IN THE UNITED STATES, 3793 02:53:55,080 --> 02:53:55,720 IN 1991, AND THIS HAS EXPERTISE 3794 02:53:55,720 --> 02:53:59,160 IN OUR STATE, THAT CANNOT BE 3795 02:53:59,160 --> 02:53:59,720 UTILIZED AND THIS IS A LOST 3796 02:53:59,720 --> 02:54:04,400 OPPORTUNITY. ALSO ADD THE OREGON 3797 02:54:04,400 --> 02:54:05,040 IS A VERY INTERESTING STATE. WE 3798 02:54:05,040 --> 02:54:05,680 DO HAVE REALIZED PSILOCYBIN FOR 3799 02:54:05,680 --> 02:54:06,360 TREATMENT OF DEPRESSION. SO IT'S 3800 02:54:06,360 --> 02:54:11,800 AN INTERESTING PLACE TO LIVE. 3801 02:54:11,800 --> 02:54:12,440 PERIPHERAL NERVE STIMULATION WAS 3802 02:54:12,440 --> 02:54:13,000 INVENTED IN THE 1960S, EVEN 3803 02:54:13,000 --> 02:54:16,440 BEFORE SPINAL CORD STIMULATION, 3804 02:54:16,440 --> 02:54:23,920 STARTING IN 2012 A NUMBER OF 3805 02:54:23,920 --> 02:54:24,440 THERAPEUTIC DEVICES THAT 3806 02:54:24,440 --> 02:54:25,080 STIMULATE PERIPHERAL NERVES OR 3807 02:54:25,080 --> 02:54:25,680 THAT PROVIDE PERIPHERAL NERVE 3808 02:54:25,680 --> 02:54:26,320 FIELD STIMULATION RECEIVED WITH 3809 02:54:26,320 --> 02:54:26,880 THE APPROVAL IN A NUMBER OF 3810 02:54:26,880 --> 02:54:27,520 REGIONS AROUND THE WORLD FOR THE 3811 02:54:27,520 --> 02:54:28,400 TREATMENT OF NEUROPATHIC PAIN, 3812 02:54:28,400 --> 02:54:32,400 AND, AND SOME GEOGRAPHIC AREAS 3813 02:54:32,400 --> 02:54:32,880 MIGRAINE HEADACHES AND 3814 02:54:32,880 --> 02:54:36,120 OVERACTIVE BLADDER, BUT NOT IN 3815 02:54:36,120 --> 02:54:37,040 ALL GEOGRAPHIC AREAS. 3816 02:54:37,040 --> 02:54:39,400 AGAIN, THIS COMES DOWN TO 3817 02:54:39,400 --> 02:54:39,640 ACCESS. 3818 02:54:39,640 --> 02:54:40,600 GEOGRAPHY CAN BE A CHALLENGE. 3819 02:54:40,600 --> 02:54:45,920 SOME RESEARCH STUDIES INCLUDE 3820 02:54:45,920 --> 02:54:48,400 TRAVEL COMPENSATION FOR 3821 02:54:48,400 --> 02:54:48,680 SUBJECTS. 3822 02:54:48,680 --> 02:54:51,160 ONE ASSUMES THAT THIS WOULD NO 3823 02:54:51,160 --> 02:54:52,920 LONGER BE AVAILABLE IF A DEVICE 3824 02:54:52,920 --> 02:54:53,520 IS SUBSEQUENTLY APPROVED FOR 3825 02:54:53,520 --> 02:55:00,000 USE. AND THEN WHAT THAT MEANS 3826 02:55:00,000 --> 02:55:00,640 THERE'S LOCAL ACCESS TO CARE AND 3827 02:55:00,640 --> 02:55:02,880 INDIVIDUALS WHO CAN HELP 3828 02:55:02,880 --> 02:55:03,440 COORDINATE OR SUPPORT THE 3829 02:55:03,440 --> 02:55:03,960 TRANSITION FROM CLINICAL 3830 02:55:03,960 --> 02:55:04,600 RESEARCH TRIAL PARTICIPANTS TO 3831 02:55:04,600 --> 02:55:07,160 STANDARD OF CARE JUST MAY NOT BE 3832 02:55:07,160 --> 02:55:16,440 AVAILABLE. FINANCIAL CONCERNS 3833 02:55:16,440 --> 02:55:17,080 AND ADEQUATE INSURANCE COVERAGE 3834 02:55:17,080 --> 02:55:19,040 IS LIKELY IN MOST CASES AT THE 3835 02:55:19,040 --> 02:55:19,600 COST OF THE INVESTIGATIONAL 3836 02:55:19,600 --> 02:55:20,400 DEVICE AND CARE WERE COVERED 3837 02:55:20,400 --> 02:55:21,040 WHILE THE PAYMENT IN THE STUDY 3838 02:55:21,040 --> 02:55:23,400 AND AN ACTIVE PARTICIPANT. AS 3839 02:55:23,400 --> 02:55:23,920 REFERENCED EARLIER, DE 3840 02:55:23,920 --> 02:55:24,480 PRIORITIZED BY THE FUNDING 3841 02:55:24,480 --> 02:55:25,560 ENTITYPATIENTS MAY BE LEFT 3842 02:55:25,560 --> 02:55:28,360 WITHOUT SUPPORT. THAT IS THE 3843 02:55:28,360 --> 02:55:29,080 BECOME TRIAL ABANDONED. 3844 02:55:29,080 --> 02:55:31,960 THE TYPE OF SPONSOR, IS IT 3845 02:55:31,960 --> 02:55:34,200 FEDERAL OR INDUSTRY SPONSOR, I 3846 02:55:34,200 --> 02:55:35,560 WONDER ALSO IF THERE IS AN 3847 02:55:35,560 --> 02:55:37,520 OPPORTUNITY TO CONSIDER LANGUAGE 3848 02:55:37,520 --> 02:55:42,960 AND CONTRACTS WITH REGARDS TO 3849 02:55:42,960 --> 02:55:45,720 THE LEVEL OF FUNDING FROM THE 3850 02:55:45,720 --> 02:55:55,040 ENTY IF THEY DO NOT COVER COST, 3851 02:55:55,040 --> 02:55:57,760 PARTICULARLY THOSE WITH DEVICE 3852 02:55:57,760 --> 02:55:58,360 MAINTENANCE. 3853 02:55:58,360 --> 02:56:01,160 AND GAPS. 3854 02:56:01,160 --> 02:56:02,040 MAINTAINING COORDINATION OF CARE 3855 02:56:02,040 --> 02:56:04,400 IS CRITICAL FOR STUDY 3856 02:56:04,400 --> 02:56:06,040 PARTICIPANTS LEAVING A TRIAL. 3857 02:56:06,040 --> 02:56:08,400 PERHAPS NIH PARTNERSHIP WITH 3858 02:56:08,400 --> 02:56:13,040 CENTERS FOR MEDICARE AND 3859 02:56:13,040 --> 02:56:15,440 MEDICAID SERVICES, AND SPONSORS 3860 02:56:15,440 --> 02:56:16,080 COULD WORK TO PROVIDE RESOURCES 3861 02:56:16,080 --> 02:56:16,640 FOR SUCH SITUATIONS, AND IT 3862 02:56:16,640 --> 02:56:19,040 SOUNDS LIKE THAT'S HAPPENED IN 3863 02:56:19,040 --> 02:56:24,560 SOME SITUATIONS AS IT WAS 3864 02:56:24,560 --> 02:56:26,960 DISCUSSED FOR NEUROCASE. 3865 02:56:26,960 --> 02:56:31,160 FUNDING FOR POST TRAIL CARE FOR 3866 02:56:31,160 --> 02:56:31,800 ALL PARTICIPANTS, A MINIMUM WAGE 3867 02:56:31,800 --> 02:56:32,360 FOR INVESTIGATIONAL DEVICE 3868 02:56:32,360 --> 02:56:33,640 REMOVAL SHOULD THE PATIENT 3869 02:56:33,640 --> 02:56:40,400 DESIRE THAT. A SOLUTION COULD BE 3870 02:56:40,400 --> 02:56:41,000 EMPLOYED TO A SOLUTION COULD BE 3871 02:56:41,000 --> 02:56:41,600 TO EMPLOY PATIENT ADVOCATES, 3872 02:56:41,600 --> 02:56:42,240 MUCH LIKE COORDINATORS WHO SERVE 3873 02:56:42,240 --> 02:56:43,040 AS LIAISONS BETWEEN THE CLINICAL 3874 02:56:43,040 --> 02:56:46,200 TRIAL TEAM, AND PATIENTS 3875 02:56:46,200 --> 02:56:46,840 THROUGHOUT THE PATIENT'S LIFE. 3876 02:56:46,840 --> 02:56:52,480 TO ENSURE THAT ONE, ARE IS 3877 02:56:52,480 --> 02:56:59,240 PROPERLY COORDINATED. TWO, NEW 3878 02:56:59,240 --> 02:56:59,840 FINDINGS FROM CLINICAL TRIAL 3879 02:56:59,840 --> 02:57:00,440 ANALYSIS ARE SHARED WITH THE 3880 02:57:00,440 --> 02:57:05,360 PATIENTS AND THREE: PATIENTS 3881 02:57:05,360 --> 02:57:05,960 CAN OBTAIN SUPPORT FOR THEIR 3882 02:57:05,960 --> 02:57:06,600 IMPLANTED DEVICES, AND WE COULD 3883 02:57:06,600 --> 02:57:07,840 THINK OF THIS AS SIMILAR TO THE 3884 02:57:07,840 --> 02:57:08,480 MANUFACTURER REPRESENTATIVES WHO 3885 02:57:08,480 --> 02:57:09,120 ARE OFTEN INVOLVED IN STANDARD 3886 02:57:09,120 --> 02:57:11,480 OF CARE, POST DEVICE. HOWEVER, 3887 02:57:11,480 --> 02:57:12,120 IN MOST CASES, ACCESS TO SUPPORT 3888 02:57:12,120 --> 02:57:14,360 AND RESOURCES, EG. FOR EXAMPLE, 3889 02:57:14,360 --> 02:57:14,840 SOCIAL WORKERS OR STUDY 3890 02:57:14,840 --> 02:57:16,480 COORDINATORS MAY BE LIMITED TO 3891 02:57:16,480 --> 02:57:19,040 THE PERIOD DIRECTLY FOLLOWING 3892 02:57:19,040 --> 02:57:20,920 CLINICAL TRIAL INVOLVEMENT, 3893 02:57:20,920 --> 02:57:23,000 RATHER THAN AN EXTENDED 3894 02:57:23,000 --> 02:57:23,520 THROUGHOUT THE PATIENT'S 3895 02:57:23,520 --> 02:57:24,400 LIFETIME, EAVING PATIENTS WITH 3896 02:57:24,400 --> 02:57:24,880 NO LONG TERM SUPPORT TO 3897 02:57:24,880 --> 02:57:29,320 COORDINATE CARE AND ABILITY TO 3898 02:57:29,320 --> 02:57:31,040 NAVIGATE INSURANCE ISSUES. 3899 02:57:31,040 --> 02:57:32,880 IT'S IMPERATIVE THAT SOLUTION BE 3900 02:57:32,880 --> 02:57:35,120 IDENTIFIED TO ENSURE NO GAPS 3901 02:57:35,120 --> 02:57:35,720 BETWEEN PATIENT CARE 3902 02:57:35,720 --> 02:57:37,080 COORDINATION AND SUPPORT, THANK 3903 02:57:37,080 --> 02:57:37,280 YOU. 3904 02:57:37,280 --> 02:57:40,400 I REALLY LOOK FORWARD TO 3905 02:57:40,400 --> 02:57:42,000 DISCUSSING OPPORTUNITIES WHERE 3906 02:57:42,000 --> 02:57:45,320 GROWTH AND DEVELOPMENT MIGHT BE. 3907 02:57:45,320 --> 02:57:52,320 DOES ANYONE HAVE ANY QUESTIONS? 3908 02:57:52,320 --> 02:57:55,080 WE HAVE TIME FOR QUESTIONS, IF 3909 02:57:55,080 --> 02:58:02,920 ANYONE HAS ONE. 3910 02:58:02,920 --> 02:58:05,960 >> I CAN ASK A QUESTION. 3911 02:58:05,960 --> 02:58:07,800 SO THIS WAS REALLY HELPFUL. 3912 02:58:07,800 --> 02:58:10,560 THANK YOU FOR YOUR INSIGHTS. 3913 02:58:10,560 --> 02:58:12,360 I WAS WONDERING IF YOU COULD 3914 02:58:12,360 --> 02:58:15,720 GIVE SOME SORT OF INSIGHTS INTO 3915 02:58:15,720 --> 02:58:19,000 WHAT FROM AN INSTITUTIONAL 3916 02:58:19,000 --> 02:58:20,600 PERSPECTIVE IS SORT OF -- 3917 02:58:20,600 --> 02:58:23,800 SOMETIMES PROVIDED, ALWAYS 3918 02:58:23,800 --> 02:58:26,960 PROVIDED, NEVER PROVIDED WHEN IT 3919 02:58:26,960 --> 02:58:30,240 COMES TO POST-TRIAL CARE. 3920 02:58:30,240 --> 02:58:32,520 >> IT'S REALLY, REALLY HARD TO 3921 02:58:32,520 --> 02:58:34,200 NAVIGATE EVEN WITHIN A STUDY. 3922 02:58:34,200 --> 02:58:36,160 AND I WOULD PUSH BACK TO A 3923 02:58:36,160 --> 02:58:38,120 COMMENT A LITTLE BIT EARLIER, MY 3924 02:58:38,120 --> 02:58:41,240 EXPERIENCE FROM RESEARCH 3925 02:58:41,240 --> 02:58:42,720 ADMINISTRATION STANDPOINT, WE DO 3926 02:58:42,720 --> 02:58:44,160 NOT MAKE MONEY OUT OF STUDIES 3927 02:58:44,160 --> 02:58:46,480 AND BARELY BREAK EVEN, IN MANY 3928 02:58:46,480 --> 02:58:49,480 CASES WE LOSE FUNDING, ON THE 3929 02:58:49,480 --> 02:58:54,960 PLUS SIDE THE PATIENTS DO GET TO 3930 02:58:54,960 --> 02:58:55,960 BILLED UP A REALLY CLOSE 3931 02:58:55,960 --> 02:58:57,640 RELATIONSHIP WITH PROVIDERS. 3932 02:58:57,640 --> 02:59:00,240 IN THIS CASE THE STUDY 3933 02:59:00,240 --> 02:59:00,560 COORDINATORS. 3934 02:59:00,560 --> 02:59:01,680 AND ONE THING I HAVE BEEN 3935 02:59:01,680 --> 02:59:03,640 THINKING ABOUT ALSO IN A BIGGER 3936 02:59:03,640 --> 02:59:06,120 SENSE IS THAT NO ONE REALLY 3937 02:59:06,120 --> 02:59:06,680 OFFERS CLINICAL RESEARCH 3938 02:59:06,680 --> 02:59:11,040 COORDINATOR EXPERIENCE AS A 3939 02:59:11,040 --> 02:59:11,520 CAREER. 3940 02:59:11,520 --> 02:59:13,040 AND I DO SEE THAT NOW AS BEING A 3941 02:59:13,040 --> 02:59:15,520 CAREER. 3942 02:59:15,520 --> 02:59:17,200 BECAUSE, THEY ARE DEFINITELY THE 3943 02:59:17,200 --> 02:59:19,640 PEOPLE WHO CAN BEST NAVIGATE 3944 02:59:19,640 --> 02:59:20,920 WHAT'S IN THE CONSENT FORM, IN 3945 02:59:20,920 --> 02:59:23,600 THE CONTRACT, AND WORK REALLY 3946 02:59:23,600 --> 02:59:26,040 CLOSELY WITH PATIENTS FOR THEIR 3947 02:59:26,040 --> 02:59:26,760 BENEFIT. 3948 02:59:26,760 --> 02:59:27,920 BUT NAVIGATING WHAT IS PROVIDED, 3949 02:59:27,920 --> 02:59:29,440 AND NOT PROVIDED IS REALLY, 3950 02:59:29,440 --> 02:59:30,800 REALLY DIFFICULT FOR THE 3951 02:59:30,800 --> 02:59:37,160 COORDINATORS OFTEN. 3952 02:59:37,160 --> 02:59:40,400 >> THANK YOU. 3953 02:59:40,400 --> 02:59:42,720 >> THANK YOU. 3954 02:59:42,720 --> 02:59:45,560 >> DR. ROBINSON BEALE, LET'S 3955 02:59:45,560 --> 02:59:48,120 CHECK IN AGAIN IF YOU HAD A 3956 02:59:48,120 --> 02:59:50,600 CHANCE WITH A DIFFERENT AUDIO 3957 02:59:50,600 --> 02:59:50,960 STRATEGY. 3958 02:59:50,960 --> 02:59:52,560 >> ALL RIGHT, CAN YOU HEAR ME 3959 02:59:52,560 --> 02:59:53,960 THIS TIME? 3960 02:59:53,960 --> 02:59:55,800 >> YES, YOU SOUND WAY BETTER. 3961 02:59:55,800 --> 02:59:57,440 >> VERY PROMISING. 3962 02:59:57,440 --> 02:59:57,800 >> PERFECT. 3963 02:59:57,800 --> 03:00:00,080 >> ALL RIGHT, GREAT. 3964 03:00:00,080 --> 03:00:04,640 THANK YOU SO MUCH. 3965 03:00:04,640 --> 03:00:06,960 SAMEER FOR YOUR GUIDANCE ON 3966 03:00:06,960 --> 03:00:08,040 THAT. 3967 03:00:08,040 --> 03:00:10,600 I WAS VERY PANICKED BY THIS, I 3968 03:00:10,600 --> 03:00:12,280 WANT YOU TO KNOW. 3969 03:00:12,280 --> 03:00:15,320 LET ME GO BACK AGAIN AND QUICKLY 3970 03:00:15,320 --> 03:00:18,680 SAY THAT WHAT I'M GOING TO 3971 03:00:18,680 --> 03:00:21,320 PRESENT IS NOT REPRESENTATIVE OF 3972 03:00:21,320 --> 03:00:22,280 ANY ONE INSURANCE. 3973 03:00:22,280 --> 03:00:24,680 WHAT I DID IN PREPARATION WAS 3974 03:00:24,680 --> 03:00:26,800 TALK TO MANY COLLEAGUES FROM 3975 03:00:26,800 --> 03:00:28,840 DIFFERENT INSURERS TO GET A 3976 03:00:28,840 --> 03:00:31,040 COMMON THEME AS TO HOW THEY 3977 03:00:31,040 --> 03:00:32,320 APPROACH THESE ISSUES AND WHAT 3978 03:00:32,320 --> 03:00:33,120 ARE THE ISSUES AND CONCERNS THAT 3979 03:00:33,120 --> 03:00:36,400 THEY HAVE. 3980 03:00:36,400 --> 03:00:40,200 AS AN OVERVIEW, IT'S REAL 3981 03:00:40,200 --> 03:00:42,480 IMPORTANT TO UNDERSTAND THAT THE 3982 03:00:42,480 --> 03:00:44,360 GENERAL THRESHOLD FOR COVERAGE 3983 03:00:44,360 --> 03:00:48,120 BY INSURERS IS THAT THE 3984 03:00:48,120 --> 03:00:50,160 TECHNOLOGY WHETHER FOR 3985 03:00:50,160 --> 03:00:50,800 DIAGNOSTIC TREATMENTS AND 3986 03:00:50,800 --> 03:00:52,960 DEVICES AND OTHERS, MUST BE 3987 03:00:52,960 --> 03:00:56,200 SUFFICIENTLY AND CONSISTENTLY 3988 03:00:56,200 --> 03:00:57,360 RESEARCH-PROVEN, AND NEEDS TO 3989 03:00:57,360 --> 03:01:01,920 SHOW IT HAS IMPACT, AND 3990 03:01:01,920 --> 03:01:04,240 EFFICACIOUS AND PROVIDES PATIENT 3991 03:01:04,240 --> 03:01:04,480 SAFETY. 3992 03:01:04,480 --> 03:01:07,040 THIS IS FOR INSURANCE COVERAGE 3993 03:01:07,040 --> 03:01:10,720 THAT IS DIFFERENT THAN A 3994 03:01:10,720 --> 03:01:11,120 BENEFIT. 3995 03:01:11,120 --> 03:01:13,840 MEANING THAT THERE IS SPECIFIC 3996 03:01:13,840 --> 03:01:16,280 INFORMATION WITHIN THE INSURANCE 3997 03:01:16,280 --> 03:01:17,960 CONTRACT THAT SAYS THAT THIS 3998 03:01:17,960 --> 03:01:19,960 PARTICULAR TYPE OF SERVICE IS 3999 03:01:19,960 --> 03:01:21,400 SOMETHING THAT IS COVERED. 4000 03:01:21,400 --> 03:01:24,720 IN MOST CASES THE THE GENERAL 4001 03:01:24,720 --> 03:01:26,120 ACCEPTED TREATMENTS ARE, BUT 4002 03:01:26,120 --> 03:01:28,680 THERE ARE SOME EXCEPTIONS THAT 4003 03:01:28,680 --> 03:01:30,400 CAN POP UP. 4004 03:01:30,400 --> 03:01:32,320 THE REASON WHY I BRING THIS UP 4005 03:01:32,320 --> 03:01:34,000 IS BECAUSE WHEN YOU LOOK AT 4006 03:01:34,000 --> 03:01:35,560 PAIRS THERE ARE DIFFERENT TYPES 4007 03:01:35,560 --> 03:01:37,400 OF PAYERS. 4008 03:01:37,400 --> 03:01:40,400 YOU HAVE EMPLOYERS WHO FUND 4009 03:01:40,400 --> 03:01:43,920 MAJORITY OF HEALTH CARE, 4010 03:01:43,920 --> 03:01:45,240 MEDICARE IS NEXT MEDICAID IS 4011 03:01:45,240 --> 03:01:47,560 NEXT AND AFTER THAT MEDICAID 4012 03:01:47,560 --> 03:01:50,320 CHIP AND AFFORDABLE CARE ACT. 4013 03:01:50,320 --> 03:01:52,160 THERE ARE ALSO THOSE 4014 03:01:52,160 --> 03:01:55,040 PROVIDERS -- LARGE SYSTEMS THAT 4015 03:01:55,040 --> 03:01:58,320 ARE CAPITATED. 4016 03:01:58,320 --> 03:01:59,840 THEY DON'T NECESSARILY CREATE 4017 03:01:59,840 --> 03:02:02,520 THEIR OWN INSURANCE BENEFITS AND 4018 03:02:02,520 --> 03:02:05,000 GENERAL COVER THE INSURANCE 4019 03:02:05,000 --> 03:02:06,600 COVERAGE, THE SCOPE OF SERVICES 4020 03:02:06,600 --> 03:02:09,760 COVERED BY THE INSURER THAT SET 4021 03:02:09,760 --> 03:02:14,400 THEM UP IN CAPITATED 4022 03:02:14,400 --> 03:02:15,600 ARRANGEMENT, AND THEN LAST 4023 03:02:15,600 --> 03:02:17,680 CATEGORY OF PAYERS ARE 4024 03:02:17,680 --> 03:02:19,040 INDIVIDUALS WHO PAY FOR THEIR 4025 03:02:19,040 --> 03:02:21,840 OWN, AND THAT'S PORTAL OF DIRECT 4026 03:02:21,840 --> 03:02:23,840 TO CONSUMER TYPE OF CARE, AND 4027 03:02:23,840 --> 03:02:25,720 MANY TIMES THOSE ARE CARE OR 4028 03:02:25,720 --> 03:02:27,320 SERVICES THAT HAVE NOT BEEN 4029 03:02:27,320 --> 03:02:29,240 PROVEN TO BE THROUGH RESEARCH. 4030 03:02:29,240 --> 03:02:32,120 AND WHAT I WOULD CALL THE 4031 03:02:32,120 --> 03:02:33,920 GROUND-UP TYPE OF RESEARCH THAT 4032 03:02:33,920 --> 03:02:37,040 IS DONE BY PROVIDERS WHO ARE 4033 03:02:37,040 --> 03:02:39,080 FINDING NEW WAYS TO APPLY 4034 03:02:39,080 --> 03:02:41,440 EXISTING TECHNOLOGIES AND MANY 4035 03:02:41,440 --> 03:02:42,840 TIMES ARE FINDING WITH 4036 03:02:42,840 --> 03:02:46,720 INDIVIDUAL PATIENTS SOME 4037 03:02:46,720 --> 03:02:47,640 POSITIVE EFFECT. 4038 03:02:47,640 --> 03:02:50,040 I BRING THAT UP, BECAUSE THAT 4039 03:02:50,040 --> 03:02:53,120 IS A WHOLE DIFFERENT ROAD TO 4040 03:02:53,120 --> 03:02:55,720 INSURANCE COVERAGE AS OPPOSED TO 4041 03:02:55,720 --> 03:02:59,440 THOSE COMING THROUGH THE TYPICAL 4042 03:02:59,440 --> 03:02:59,920 RO 4043 03:02:59,920 --> 03:03:02,320 ROUTE OF CLINICAL TRIALS AND 4044 03:03:02,320 --> 03:03:02,760 RESEARCH, AND OTHER 4045 03:03:02,760 --> 03:03:05,600 METHODOLOGIES. 4046 03:03:05,600 --> 03:03:07,440 THE FACTORS THAT IMPACT 4047 03:03:07,440 --> 03:03:09,160 INSURANCE COVERAGE ARE THE 4048 03:03:09,160 --> 03:03:11,360 DIFFERENCE IN THE PAYER SOURCES 4049 03:03:11,360 --> 03:03:13,200 AS I MENTIONED. 4050 03:03:13,200 --> 03:03:16,000 POLICY VERSUS BENEFIT WHICH I 4051 03:03:16,000 --> 03:03:24,480 JUST MENTIONED AND THE DIVE 4052 03:03:24,480 --> 03:03:30,440 DIVERGENCE OF COST OFFSET. 4053 03:03:30,440 --> 03:03:31,080 THAT HAS BEEN ALLUDED TO BY MANY 4054 03:03:31,080 --> 03:03:31,680 OF THE PANELISTS THAT ON THE 4055 03:03:31,680 --> 03:03:32,960 MANUFACTURERS SIDE BUT ALSO ON 4056 03:03:32,960 --> 03:03:33,560 THE INSURANCE COVERAGE SIGN. 4057 03:03:33,560 --> 03:03:36,400 THERE IS A CONSIDERATION, 4058 03:03:36,400 --> 03:03:40,400 CERTAINLY NOT THE ONLY 4059 03:03:40,400 --> 03:03:40,960 CONSIDERATION, BUT IT IS A 4060 03:03:40,960 --> 03:03:41,520 CONSIDERATION IN LOOKING AT 4061 03:03:41,520 --> 03:03:42,960 COVERAGE IS THAT, OF HAVING A 4062 03:03:42,960 --> 03:03:43,560 COST OFFSET. REASON BEING IS IF 4063 03:03:43,560 --> 03:03:46,400 YOU LOOK AT INSURANCE OR 4064 03:03:46,400 --> 03:03:49,720 PAYERS -- I WON'T SAY BANKERS -- 4065 03:03:49,720 --> 03:03:51,200 BUT THE ADMINISTRATOR OVER A 4066 03:03:51,200 --> 03:03:51,560 TRUST. 4067 03:03:51,560 --> 03:03:53,240 AND THE TRUST HAS A CERTAIN 4068 03:03:53,240 --> 03:03:54,840 AMOUNT OF MONEY IN IT. 4069 03:03:54,840 --> 03:03:57,760 AND IT IS TO BE APPLIED TO THE 4070 03:03:57,760 --> 03:03:58,840 POPULATION IT SERVES. 4071 03:03:58,840 --> 03:04:00,840 SO PART OF THE DECISION-MAKING 4072 03:04:00,840 --> 03:04:02,840 IS AS NEW TECHNOLOGIES COME IN, 4073 03:04:02,840 --> 03:04:05,280 HOW DO YOU FIT THAT WITHIN THE 4074 03:04:05,280 --> 03:04:06,840 CERTAIN AMOUNT OF MONEY THAT IS 4075 03:04:06,840 --> 03:04:09,480 THERE TO BE DISTRIBUTED TO THE 4076 03:04:09,480 --> 03:04:12,160 POPULATION THAT WOULD BE 4077 03:04:12,160 --> 03:04:12,800 UTILIZING SERVICES. 4078 03:04:12,800 --> 03:04:19,720 WE KNOW NOW THAT 5-7% OF THE 4079 03:04:19,720 --> 03:04:24,400 POPULATION CONSUMES 82% OF THE 4080 03:04:24,400 --> 03:04:26,400 DOLLARS, FOR MEDICAL COVERAGE. 4081 03:04:26,400 --> 03:04:30,560 RECOGNIZING THIS DIFFERENCE IT 4082 03:04:30,560 --> 03:04:34,160 IS VERY IMPORTANT TO UNDERSTAND 4083 03:04:34,160 --> 03:04:39,600 WHEN SOMETHING IS PROVEN 4084 03:04:39,600 --> 03:04:40,400 EFFICACIOUS AND MANY OTHER 4085 03:04:40,400 --> 03:04:43,040 QUESTIONS THAT NEED TO BE ASKED. 4086 03:04:43,040 --> 03:04:45,760 I THINK DR. LI STARTED SOME OF 4087 03:04:45,760 --> 03:04:48,240 THOSE, AND I'LL JUST ADD TO SOME 4088 03:04:48,240 --> 03:04:49,040 OF THOSE QUESTIONS. 4089 03:04:49,040 --> 03:04:50,440 IT'S NOT ONLY LOOKING AT WHETHER 4090 03:04:50,440 --> 03:04:55,200 IT'S EFFICACIOUS BUT HOW LONG IS 4091 03:04:55,200 --> 03:05:00,680 IT EFFICACIOUS? 4092 03:05:00,680 --> 03:05:05,560 DOES IT NEED TO BE REPEATED? 4093 03:05:05,560 --> 03:05:06,040 WHAT'S THE LONG TERM 4094 03:05:06,040 --> 03:05:06,600 RAMIFICATIONS OF USING THIS 4095 03:05:06,600 --> 03:05:07,200 PARTICULAR TREATMENT, OR THIS 4096 03:05:07,200 --> 03:05:12,400 DIAGNOSTIC SO THAT ONE BEGINS TO 4097 03:05:12,400 --> 03:05:12,960 UNDERSTAND THIS THIS PERSON 4098 03:05:12,960 --> 03:05:13,800 GOING TO NEED TO HAVE ONGOING 4099 03:05:13,800 --> 03:05:18,280 CARE, WE TALKED ABOUT 4100 03:05:18,280 --> 03:05:18,920 REPLACEMENT REPEAT SURGERY, ALL 4101 03:05:18,920 --> 03:05:19,520 OF THOSE PIECES NEED TO BE TAKEN 4102 03:05:19,520 --> 03:05:20,120 IN CONSIDERATION AS WELL AS 4103 03:05:20,120 --> 03:05:24,400 IDENTIFIED IN ANSWERED TO GIVE A 4104 03:05:24,400 --> 03:05:24,920 FULL SCOPE OF WHAT THIS 4105 03:05:24,920 --> 03:05:28,360 PARTICULAR PROCEDURE IN THE LONG 4106 03:05:28,360 --> 03:05:29,000 RUN IS GOING TO CAUSE AND HOW IT 4107 03:05:29,000 --> 03:05:29,640 FITS INTO THIS GENERAL POT THAT 4108 03:05:29,640 --> 03:05:30,200 I'VE DESCRIBED. THAT IS THE 4109 03:05:30,200 --> 03:05:30,800 GENERAL POT OF MONEY THAT IS 4110 03:05:30,800 --> 03:05:32,280 USED FOR THE TOTAL POPULATION. 4111 03:05:32,280 --> 03:05:33,840 THE REASON WHY THAT IS IMPORTANT 4112 03:05:33,840 --> 03:05:37,880 AND AS WE ALL ARE AWARE IN 4113 03:05:37,880 --> 03:05:39,480 UNITED STATES HEALTH CARE IS 4114 03:05:39,480 --> 03:05:41,440 EXTREMELY EXPENSIVE. 4115 03:05:41,440 --> 03:05:43,120 AND OVERALL OUTCOME AND 4116 03:05:43,120 --> 03:05:45,560 COMPARISON TO OTHER COUNTRIES IS 4117 03:05:45,560 --> 03:05:46,960 VERY POOR. 4118 03:05:46,960 --> 03:05:49,040 BUT ALSO EXPERIENCING CONTINUING 4119 03:05:49,040 --> 03:05:50,520 EXPERIENCE OF ESCALATING HEALTH 4120 03:05:50,520 --> 03:05:53,080 CARE COSTS THAT GETS PASSED ON 4121 03:05:53,080 --> 03:05:55,040 TO INDIVIDUALS TERMS OF PREMIUMS 4122 03:05:55,040 --> 03:05:57,320 AND COPAYMENTS AND COINSURANCE 4123 03:05:57,320 --> 03:05:59,520 ON A WAY TO TRY AND CURB SOME OF 4124 03:05:59,520 --> 03:06:00,200 THAT COST. 4125 03:06:00,200 --> 03:06:04,360 IN TERMS OF LOOKING AT THOSE 4126 03:06:04,360 --> 03:06:09,440 TECHNOLOGIES AND WHETHER OR NOT 4127 03:06:09,440 --> 03:06:09,680 COVERED. 4128 03:06:09,680 --> 03:06:11,480 DR. LI MENTIONED THE WHOLE 4129 03:06:11,480 --> 03:06:13,320 EVIDENCE -- THE HIERARCHY OF 4130 03:06:13,320 --> 03:06:15,480 EVIDENCE USED. 4131 03:06:15,480 --> 03:06:18,000 METAANALYSIS, RANDOMIZED 4132 03:06:18,000 --> 03:06:20,400 CLINICAL TRIALS, AND THOSE IN 4133 03:06:20,400 --> 03:06:23,080 LARGE RANDOMIZED TRIALS. 4134 03:06:23,080 --> 03:06:24,000 WHAT IS REALLY IMPORTANT IN MOST 4135 03:06:24,000 --> 03:06:26,520 HEALTH PLANS, THERE IS A POLICY 4136 03:06:26,520 --> 03:06:29,640 COMMITTEE THAT LOOKS AT THE 4137 03:06:29,640 --> 03:06:30,720 EVIDENCE, REVIEWS THE EVIDENCE 4138 03:06:30,720 --> 03:06:31,960 AND DETERMINES WHETHER OR NOT 4139 03:06:31,960 --> 03:06:34,080 THE EVIDENCE THAT HAS BEEN 4140 03:06:34,080 --> 03:06:42,840 PRESENTEDED DEMONSTRATES EFFECT 4141 03:06:42,840 --> 03:06:43,440 EFFICACIOUSNESS IN TERMS OF A 4142 03:06:43,440 --> 03:06:45,920 PATIENT POPULATION. HOPEFULLY 4143 03:06:45,920 --> 03:06:46,560 THAT IT'S SPECIFIC ENOUGH THAT 4144 03:06:46,560 --> 03:06:47,160 ONE CAN IDENTIFY THE PATIENTS 4145 03:06:47,160 --> 03:06:47,920 THAT PARTICULAR TECHNOLOGY WILL 4146 03:06:47,920 --> 03:06:49,200 WORK BEST FOR AND IDENTIFY WHO 4147 03:06:49,200 --> 03:06:51,000 IS WHAT TYPE OF TRAINING IS 4148 03:06:51,000 --> 03:06:55,040 NECESSARY FOR THAT TECHNOLOGY TO 4149 03:06:55,040 --> 03:06:59,440 BE RENDERED, AND RENDERED WELL 4150 03:06:59,440 --> 03:07:00,360 WITH FIDELITY. 4151 03:07:00,360 --> 03:07:04,960 AS FELL, AS I MENTIONED BEFORE, 4152 03:07:04,960 --> 03:07:07,440 HOW LONG DOES TREATMENT OCCUR. 4153 03:07:07,440 --> 03:07:11,200 . WHAT'S THE LONG TERM EFFECT, 4154 03:07:11,200 --> 03:07:11,800 ALL OF THOSE PIECES. EVEN IF THE 4155 03:07:11,800 --> 03:07:12,400 EVIDENCE IS NOT PRESENT, AND 4156 03:07:12,400 --> 03:07:13,040 PARTICULARLY IF IT'S A CONDITION 4157 03:07:13,040 --> 03:07:16,200 THAT THERE IS THE POSSIBILITY OF 4158 03:07:16,200 --> 03:07:16,720 IMMINENT DEATH. THERE ARE 4159 03:07:16,720 --> 03:07:18,560 REGULATIONS THAT REALLY REQUIRE 4160 03:07:18,560 --> 03:07:20,600 PAYERS TO COVER NONPROVEN 4161 03:07:20,600 --> 03:07:22,880 TECHNOLOGIES WITH A CERTAIN 4162 03:07:22,880 --> 03:07:25,080 LEVEL OF RIGOR IN THOSE 4163 03:07:25,080 --> 03:07:27,440 TECHNOLOGIES, AND MOST COMMONLY 4164 03:07:27,440 --> 03:07:28,480 APPLIED TO CANCER. 4165 03:07:28,480 --> 03:07:30,920 THE OTHER AREAS THAT ARE USED 4166 03:07:30,920 --> 03:07:32,440 TO DETERMINE THINGS THAT ARE 4167 03:07:32,440 --> 03:07:34,640 COVERED ARE THOSE THAT ARE 4168 03:07:34,640 --> 03:07:36,720 CONSIDERED WIDELY ACCEPTED 4169 03:07:36,720 --> 03:07:37,560 MEDICAL PRACTICES, AND GENERALLY 4170 03:07:37,560 --> 03:07:40,960 THOSE ARE THINGS THAT HAVE BEEN 4171 03:07:40,960 --> 03:07:42,680 LONG STANDING AND HAVE NOT 4172 03:07:42,680 --> 03:07:44,080 NECESSARILY GONE THROUGH THE 4173 03:07:44,080 --> 03:07:46,480 RIGOR OF RESEARCH, FORMAL 4174 03:07:46,480 --> 03:07:48,560 RESEARCH, BUT HAS BEEN VETTED 4175 03:07:48,560 --> 03:07:51,880 THROUGH THE WIDE POPULATION 4176 03:07:51,880 --> 03:07:54,000 EXPOSURE TO THOSE PARTICULAR 4177 03:07:54,000 --> 03:07:54,240 SERVICES. 4178 03:07:54,240 --> 03:07:56,080 OTHERS ARE PROVIDED 4179 03:07:56,080 --> 03:07:59,600 ORGANIZATIONS THAT GENERATE 4180 03:07:59,600 --> 03:08:00,280 EVIDENCE-BASED GUIDELINES THAT 4181 03:08:00,280 --> 03:08:02,320 IS COMBINATION OF RESEARCH, AND 4182 03:08:02,320 --> 03:08:03,280 ALSO PRACTICE WHERE THEY BRING 4183 03:08:03,280 --> 03:08:05,040 IN EXPERIENCE OF PROVIDERS 4184 03:08:05,040 --> 03:08:08,120 RENDERING THE SERVICES AND HELP 4185 03:08:08,120 --> 03:08:09,560 TO COMBINE THAT INFORMATION 4186 03:08:09,560 --> 03:08:14,080 TOGETHER TO DEVELOP GUIDELINES, 4187 03:08:14,080 --> 03:08:15,040 PRACTICAL GUIDELINES. 4188 03:08:15,040 --> 03:08:16,440 AND THEN NATIONAL CONSENSUS 4189 03:08:16,440 --> 03:08:18,760 STATEMENTS AND PUBLICATIONS THAT 4190 03:08:18,760 --> 03:08:20,680 ARE USED. 4191 03:08:20,680 --> 03:08:21,640 >> I THINK WE LOST THE 4192 03:08:21,640 --> 03:08:25,360 CONNECTION. 4193 03:08:25,360 --> 03:08:27,760 >>OUR LAST SPEAKER OF THE 4194 03:08:27,760 --> 03:08:30,040 SESSION, A PLEASURE TO INTRODUCE 4195 03:08:30,040 --> 03:08:32,800 IS DR. LANGHALS. 4196 03:08:32,800 --> 03:08:40,200 WHO SERVES AS SUPERVISORY 4197 03:08:40,200 --> 03:08:43,720 PROGRAM DIRECTOR, LEADING THE 4198 03:08:43,720 --> 03:08:50,400 TRANSLATIONAL DEVICES TEAM WITH 4199 03:08:50,400 --> 03:08:50,920 WITHIN THE DIVISION OF 4200 03:08:50,920 --> 03:08:51,680 TRANSLATIONAL RESEARCH E IS A 4201 03:08:51,680 --> 03:08:52,280 TEAM LEAD IN BOTH THE UNITED 4202 03:08:52,280 --> 03:08:55,720 BRAIN INITIATIVE, AS WELL AS THE 4203 03:08:55,720 --> 03:08:56,360 BLUEPRINT MED TECH PROGRAM AND 4204 03:08:56,360 --> 03:08:56,920 HIS TEAM ALSO LEADS EFFORTS 4205 03:08:56,920 --> 03:08:57,440 WITHIN THE STIMULATING 4206 03:08:57,440 --> 03:08:58,080 PERIPHERAL ACTIVITY TO RELIEVE 4207 03:08:58,080 --> 03:09:04,800 CONDITIONS SPARK PROGRAM, AND 4208 03:09:04,800 --> 03:09:07,240 LONG TERM THE HEAL INITIATIVE. 4209 03:09:07,240 --> 03:09:07,840 CURRENTLY OVERSEES THE GRANT 4210 03:09:07,840 --> 03:09:08,480 PORTFOLIO IN THE AREAS OF NEURO 4211 03:09:08,480 --> 03:09:09,000 TECHNOLOGY DEVELOPMENT 4212 03:09:09,000 --> 03:09:09,600 VALIDATION AND TRANSLATION FOR 4213 03:09:09,600 --> 03:09:14,400 APPLICATIONS IN NEUROSCIENCE AND 4214 03:09:14,400 --> 03:09:23,800 PHYSIOLOGY MOVING DISORDERS. DR. 4215 03:09:23,800 --> 03:09:24,080 LANGHALS. 4216 03:09:24,080 --> 03:09:26,480 >> I'LL JUST WALK THROUGH 4217 03:09:26,480 --> 03:09:27,720 LITTLE BIT OF THE NIH SIDE OF 4218 03:09:27,720 --> 03:09:27,960 THINGS. 4219 03:09:27,960 --> 03:09:32,960 ND WHAT I'VE DONE AND WE'VE 4220 03:09:32,960 --> 03:09:35,760 DONE WITHIN SEVERAL OF OUR 4221 03:09:35,760 --> 03:09:36,360 TRANSLATION WILL PROGRAMS AS IT 4222 03:09:36,360 --> 03:09:37,000 RELATES TO LOOKING AT CONTINUING 4223 03:09:37,000 --> 03:09:37,600 TRIAL RESPONSIBILITIES AND 4224 03:09:37,600 --> 03:09:37,960 POST-TRIAL CARE. 4225 03:09:37,960 --> 03:09:39,720 NEXT SLIDE. 4226 03:09:39,720 --> 03:09:50,240 SO OVERALL IN OUR PROGRAMS, AND 4227 03:09:52,240 --> 03:09:52,680 THE BRAND INITIATIVE IN 4228 03:09:52,680 --> 03:09:55,080 PARTICULAR, WE SUPPORT VARIOUS 4229 03:09:55,080 --> 03:09:55,720 DIFFERENT FUNDING OPPORTUNITIES 4230 03:09:55,720 --> 03:09:56,320 FROM VERY EARLY STAGE AND OF 4231 03:09:56,320 --> 03:09:56,920 CONCEPT GENERATION AND DEVICE 4232 03:09:56,920 --> 03:09:59,720 DEVELOPMENT ALL THE WAY THROUGH 4233 03:09:59,720 --> 03:10:00,360 LOTS OF THE THESE ACTIVITIES IN 4234 03:10:00,360 --> 03:10:01,920 FIRST IN HUMAN TRIALS OF NEW 4235 03:10:01,920 --> 03:10:02,480 DEVICES, EARLY FEASIBILITY 4236 03:10:02,480 --> 03:10:03,000 STUDIES AND AN ADDITIONAL 4237 03:10:03,000 --> 03:10:03,560 ACTIVITIES IN THE CLINICAL 4238 03:10:03,560 --> 03:10:09,520 TRIALS PIPELINE. IN PARTICULAR, 4239 03:10:09,520 --> 03:10:10,120 AS NOTED HERE, WITH WITHIN MY 4240 03:10:10,120 --> 03:10:10,760 GROUP WE'RE MANAGING ACTIVITIES 4241 03:10:10,760 --> 03:10:11,720 BOTH WITHIN THESE BRAIN 4242 03:10:11,720 --> 03:10:12,280 INITIATIVE PROGRAMS IN THE 4243 03:10:12,280 --> 03:10:12,840 SUPPORT BOTH THE LATE STAGE 4244 03:10:12,840 --> 03:10:16,800 PRECLINICAL DEVELOPMENT. AND 4245 03:10:16,800 --> 03:10:18,680 FIRST IN HUMAN TRIALS IN THE 4246 03:10:18,680 --> 03:10:20,400 PHASE 2 AWARD. 4247 03:10:20,400 --> 03:10:22,920 AND AS WELL AS APPLICATION FOR 4248 03:10:22,920 --> 03:10:25,280 DIRECT TO UH3'S, FOR THOSE READY 4249 03:10:25,280 --> 03:10:27,440 TO BEGIN THE CLINICAL TRIAL OF 4250 03:10:27,440 --> 03:10:29,400 THE TECHNOLOGY IN NEW TARGET OR 4251 03:10:29,400 --> 03:10:30,280 NEW INDICATION. 4252 03:10:30,280 --> 03:10:37,120 AND SIMILARLY, WE SYNERGIZED A 4253 03:10:37,120 --> 03:10:37,680 LOT OF THE LANGUAGE IN OUR 4254 03:10:37,680 --> 03:10:38,400 FUNDING OPPORTUNITIES ACROSS THE 4255 03:10:38,400 --> 03:10:42,640 NEWLY LAUNCHED BLUEPRINT MED 4256 03:10:42,640 --> 03:10:43,240 TECH PROGRAM THAT IS DESIGNED 4257 03:10:43,240 --> 03:10:45,680 AROUND FACILITATING SOME OF 4258 03:10:45,680 --> 03:10:46,800 THESE ACTIVITIES AND PROGRAMS 4259 03:10:46,800 --> 03:10:48,600 THAT ALSO SUPPORT THESE AREAS OF 4260 03:10:48,600 --> 03:10:49,080 TECHNOLOGY DEVELOPMENT. 4261 03:10:49,080 --> 03:10:59,280 NEXT SLIDE. 4262 03:11:03,800 --> 03:11:04,360 SO KIND OF THE MAIN DIFFERENCES 4263 03:11:04,360 --> 03:11:07,800 AS I MENTIONED, THESE PROGRAMS 4264 03:11:07,800 --> 03:11:08,440 ARE TO SUPPORT THESE TECHNOLOGY 4265 03:11:08,440 --> 03:11:11,760 DEVELOPMENT ACTIVITIES. PROGRAM 4266 03:11:11,760 --> 03:11:12,280 SUPPORT THOSE WITHIN OUR 4267 03:11:12,280 --> 03:11:12,920 MISSION. HOWEVER FOR THE BRAIN 4268 03:11:12,920 --> 03:11:14,720 INITIATIVE PROGRAMS. THERE ARE 4269 03:11:14,720 --> 03:11:15,760 10 PARTICIPATING INSTITUTES AND 4270 03:11:15,760 --> 03:11:17,840 CENTERS THAT WE ARE MANAGING 4271 03:11:17,840 --> 03:11:18,360 THESE VARIOUS DIFFERENT 4272 03:11:18,360 --> 03:11:18,920 TRANSLATIONAL ACTIVITIES ON 4273 03:11:18,920 --> 03:11:25,160 BEHALF OF THE FED IN THE AREA OF 4274 03:11:25,160 --> 03:11:26,400 INVASIVE NEURAL DEVICES FOR BOTH 4275 03:11:26,400 --> 03:11:27,720 RECORDING AND STIMULATING TO 4276 03:11:27,720 --> 03:11:28,360 TREAT AND DIAGNOSE DISORDERS OF 4277 03:11:28,360 --> 03:11:29,840 THE CENTRAL NERVOUS SYSTEM AS 4278 03:11:29,840 --> 03:11:31,720 WELL AS TO ACCOMPLISH THE GOALS 4279 03:11:31,720 --> 03:11:33,440 OF THE BRAIN INITIATIVE WHICH 4280 03:11:33,440 --> 03:11:34,080 INCLUDING TO BETTER UNDERSTAND 4281 03:11:34,080 --> 03:11:37,040 THE CIRCUITS WITHIN THE BRAIN. 4282 03:11:37,040 --> 03:11:37,640 AND THE SECONDARY GOAL OF OUR 4283 03:11:37,640 --> 03:11:38,280 PROGRAMS IN THE BRAIN INITIATIVE 4284 03:11:38,280 --> 03:11:41,520 OR FACILITATE THESE PUBLIC 4285 03:11:41,520 --> 03:11:43,600 PRIVATE PARTNERSHIPS BETWEEN 4286 03:11:43,600 --> 03:11:44,240 INVESTIGATORS AND MANUFACTURERS 4287 03:11:44,240 --> 03:11:44,880 HAVE THE LATEST GENERATION WITH 4288 03:11:44,880 --> 03:11:45,480 THE STIMULATING AND RECORDING 4289 03:11:45,480 --> 03:11:50,120 DEVICES. AND SIMILARLY WITHIN 4290 03:11:50,120 --> 03:11:51,240 THE BLUE PRINT MEDICINE TECH 4291 03:11:51,240 --> 03:11:53,120 PROGRAM IS DESIGNED TO NOT ONLY 4292 03:11:53,120 --> 03:11:54,840 PROVIDE FUNDING FOR SUPPORTING 4293 03:11:54,840 --> 03:11:56,400 THESE ACTIVITY, BUT ALSO SETTING 4294 03:11:56,400 --> 03:11:59,440 UP VARIOUS CONTRACT AND 4295 03:11:59,440 --> 03:12:01,040 CONSULTAN 4296 03:12:01,040 --> 03:12:07,720 CONSULTANTSY RESOURCES AND 4297 03:12:07,720 --> 03:12:08,280 INCUBATOR HUBS TO HELP THE 4298 03:12:08,280 --> 03:12:08,920 INVESTIGATORS WORK AT ALONG THIS 4299 03:12:08,920 --> 03:12:11,720 DEVELOPMENT PIPELINE FOR 4300 03:12:11,720 --> 03:12:14,520 BRINGING NEW TECHNOLOGIES AND 4301 03:12:14,520 --> 03:12:15,120 NOVEL TECHNOLOGIES ALONG THAT 4302 03:12:15,120 --> 03:12:15,720 PIPELINE TOWARDS DE RISKING THEM 4303 03:12:15,720 --> 03:12:19,760 FOR THE FIRST IN HUMAN 4304 03:12:19,760 --> 03:12:20,320 DEMONSTRATION IN THE BRAIN 4305 03:12:20,320 --> 03:12:23,360 INITIATIVE HAS HAS SIGNED ON TO 4306 03:12:23,360 --> 03:12:23,960 THAT BLUEPRINT MED TECH PROGRAM 4307 03:12:23,960 --> 03:12:24,600 AS WELL TO POTENTIALLY SUPPORT 4308 03:12:24,600 --> 03:12:25,200 ACTIVITIES WITHIN THE BRAIN 4309 03:12:25,200 --> 03:12:26,880 INITIATIVE'S MISSION. . 4310 03:12:26,880 --> 03:12:27,520 NEXT SLIDE. 4311 03:12:27,520 --> 03:12:30,000 IN TERMS OF OVERALL PUBLIC 4312 03:12:30,000 --> 03:12:32,280 PRIVATE PARTNERSHIP PROGRAM, ONE 4313 03:12:32,280 --> 03:12:34,720 OF THE THINGS TO NOTE IS THAT IN 4314 03:12:34,720 --> 03:12:38,520 GENERAL NIH IS SERVING A ROLE TO 4315 03:12:38,520 --> 03:12:42,480 HELP FACILITATE THESE 4316 03:12:42,480 --> 03:12:43,720 PARTNERSHIPS, BUT NOT 4317 03:12:43,720 --> 03:12:45,120 NECESSARILY A PARTY FROM THE 4318 03:12:45,120 --> 03:12:46,000 LEGAL PERSPECTIVE TO THE 4319 03:12:46,000 --> 03:12:46,720 INDIVIDUAL AGREEMENT. 4320 03:12:46,720 --> 03:12:49,440 SO YOU CAN SEE THE GENERAL 4321 03:12:49,440 --> 03:12:50,640 PROCESS, WHEREBY THE APPLICANT, 4322 03:12:50,640 --> 03:12:53,560 THE ACADEMIC PI IDENTIFIES THE 4323 03:12:53,560 --> 03:12:56,880 COMPANY COLLABORATOR, VICE VERSA 4324 03:12:56,880 --> 03:13:00,000 AND SIGN THEIR OWN CONFLICT 4325 03:13:00,000 --> 03:13:01,400 DISCLOSURE AGREEMENT BETWEEN THE 4326 03:13:01,400 --> 03:13:02,240 VARIOUS ORGANIZATIONS. 4327 03:13:02,240 --> 03:13:04,120 AND THEN CAN USE THAT 4328 03:13:04,120 --> 03:13:06,040 PARTNERSHIP TO SUBMIT 4329 03:13:06,040 --> 03:13:07,480 APPLICATION TO EITHER THESE 4330 03:13:07,480 --> 03:13:11,720 BRAIN UG3 OR UH3 OR DIRECT UHV 4331 03:13:11,720 --> 03:13:12,360 FUNDING OPPORTUNITIES THAT 4332 03:13:12,360 --> 03:13:13,760 INCLUDE A LETTER OF SUPPORT FROM 4333 03:13:13,760 --> 03:13:14,080 THE COMPANY. 4334 03:13:14,080 --> 03:13:16,600 AND FOR APPLICATIONS THAT SCORE 4335 03:13:16,600 --> 03:13:18,080 WELL AND LOOKING AT PROPOSING 4336 03:13:18,080 --> 03:13:20,120 FOR FUNDING, WE DO REQUIRE THAT 4337 03:13:20,120 --> 03:13:23,720 THE ACADEMIC INVESTIGATOR, 4338 03:13:23,720 --> 03:13:25,720 AND/OR INVESTIGATORS AS WELL AS 4339 03:13:25,720 --> 03:13:28,720 THE COMPANY SIGN A COLLABORATIVE 4340 03:13:28,720 --> 03:13:32,680 RESEARCH AGREEMENT OR CLINICAL 4341 03:13:32,680 --> 03:13:34,400 TRIALS AGREEMENT PRIOR TO THE 4342 03:13:34,400 --> 03:13:35,800 NOTICE OF GRAND AWARD. 4343 03:13:35,800 --> 03:13:37,360 HOWEVER WE CAN NOT DICTATE THE 4344 03:13:37,360 --> 03:13:38,640 TERMS OF THOSE AGREEMENTS 4345 03:13:38,640 --> 03:13:40,400 BETWEEN THE VARIOUS DIFFERENT 4346 03:13:40,400 --> 03:13:40,720 PARTIES. 4347 03:13:40,720 --> 03:13:43,280 SO AS PART OF OUR CURRENT PUBLIC 4348 03:13:43,280 --> 03:13:43,960 PRIVATE PARTNERSHIP ACTIVITIES 4349 03:13:43,960 --> 03:13:45,320 WE HAVE SEVERAL DIFFERENT 4350 03:13:45,320 --> 03:13:47,440 COMPANIES THAT HAVE SIGNED ON 4351 03:13:47,440 --> 03:13:51,480 WITH MOU, MEMORANDUM OF 4352 03:13:51,480 --> 03:13:53,400 UNDERSTANDING WITH THE NIH TO 4353 03:13:53,400 --> 03:13:56,000 SHARE INFORMATION ABOUT THEIR 4354 03:13:56,000 --> 03:13:57,640 TECHNOLOGIES, AND YOU CAN SEE 4355 03:13:57,640 --> 03:14:00,040 THE LIST OF COMPANIES CURRENTLY 4356 03:14:00,040 --> 03:14:01,320 PARTICIPATING ON THE PLOT HERE, 4357 03:14:01,320 --> 03:14:03,080 AND NOTE SEVERAL OF THE 4358 03:14:03,080 --> 03:14:04,600 COMPANIES YOU HEARD ABOUT TODAY 4359 03:14:04,600 --> 03:14:07,000 ARE ACTIVELY PARTICIPATING. 4360 03:14:07,000 --> 03:14:08,560 NEXT SLIDE. 4361 03:14:08,560 --> 03:14:11,720 SO, AS PART OF THE GRANT 4362 03:14:11,720 --> 03:14:17,440 APPLICATIONS, IT WAS MENTIONED 4363 03:14:17,440 --> 03:14:18,520 EARLIER TODAY, WE DO HAVE THE 4364 03:14:18,520 --> 03:14:20,760 ABILITY TO SET UP LONG TERM CARE 4365 03:14:20,760 --> 03:14:23,280 PLAN ATTACHMENTS AS PART OF OUR 4366 03:14:23,280 --> 03:14:24,520 FUNDING OPPORTUNITIES AND WITH 4367 03:14:24,520 --> 03:14:26,680 EACH ONE OF MY PROGRAMS WITHIN 4368 03:14:26,680 --> 03:14:31,320 THE BRAIN INITIATIVE. 4369 03:14:31,320 --> 03:14:32,400 WE HAVE MADE THIS REQUIREMENT 4370 03:14:32,400 --> 03:14:34,400 FOR APPLICANTS COMING INTO THE 4371 03:14:34,400 --> 03:14:35,600 FUNDING OPPORTUNITY, AND 4372 03:14:35,600 --> 03:14:38,800 SEPARATE ATTACHMENT, SO DOESN'T 4373 03:14:38,800 --> 03:14:40,400 TAKE AWAY FROM THE PAGE LIMITS 4374 03:14:40,400 --> 03:14:42,760 OF THE REST OF THE APPLICATION. 4375 03:14:42,760 --> 03:14:45,240 AND THEY CAN HAVE INSTRUCTIONS 4376 03:14:45,240 --> 03:14:46,600 AS PART OF THE FUNDING 4377 03:14:46,600 --> 03:14:48,440 OPPORTUNITIES, DICTATING THE 4378 03:14:48,440 --> 03:14:50,240 APPLICANTS REALLY SHOULD BE 4379 03:14:50,240 --> 03:14:52,320 DESCRIBING THE ANTICIPATED CARE 4380 03:14:52,320 --> 03:14:55,720 NEEDS AS IT RELATES TO STUDIES, 4381 03:14:55,720 --> 03:14:59,080 AND LOOKING AT APPLICATIONS TO 4382 03:14:59,080 --> 03:15:01,640 POST-TRIAL SCENARIOS AND WHETHER 4383 03:15:01,640 --> 03:15:05,080 THE DEVICE IS TRIAL OR FAILURE 4384 03:15:05,080 --> 03:15:06,600 OR SUCCESS. 4385 03:15:06,600 --> 03:15:08,520 AND BASED ON THE PREDESCRIBED 4386 03:15:08,520 --> 03:15:10,360 OUTCOMES, AND AS WELL WHAT MAY 4387 03:15:10,360 --> 03:15:12,240 HAPPEN IN THE DEVICE 4388 03:15:12,240 --> 03:15:14,200 MANUFACTURES DISCONTINUE THE 4389 03:15:14,200 --> 03:15:16,800 PRODUCT OR FAIL TO COMMERCIALIZE 4390 03:15:16,800 --> 03:15:17,000 IT. 4391 03:15:17,000 --> 03:15:19,240 IN PARTICULAR THE APPLICANTS 4392 03:15:19,240 --> 03:15:21,760 SHOULD REALLY BE LOOKING AT END 4393 03:15:21,760 --> 03:15:24,880 OF TRIAL STUDY PLANS, AND 4394 03:15:24,880 --> 03:15:26,480 VARIOUS DIFFERENT SITUATIONS 4395 03:15:26,480 --> 03:15:27,720 RELATED TO THE RISKS AND 4396 03:15:27,720 --> 03:15:29,080 BENEFITS OF RECEIVING THE CARE 4397 03:15:29,080 --> 03:15:30,880 OR NOT RECEIVING THE CARE. 4398 03:15:30,880 --> 03:15:32,560 AND PROVIDE SOME EXAMPLES OF THE 4399 03:15:32,560 --> 03:15:34,320 THINGS THAT THE PLANS MAY 4400 03:15:34,320 --> 03:15:36,920 INCLUDE THAT YOU HEARD ABOUT 4401 03:15:36,920 --> 03:15:41,600 EARLIER TODAY INCLUDING PLAN TO 4402 03:15:41,600 --> 03:15:47,720 THE DEVICES. 4403 03:15:47,720 --> 03:15:49,320 ONCE IT'S COMPLETE. 4404 03:15:49,320 --> 03:15:49,920 POTENTIAL SURGICAL REMOVAL OF 4405 03:15:49,920 --> 03:15:50,480 THE BATTERY AND CAPPING THE 4406 03:15:50,480 --> 03:15:52,600 LEADS TO MINIMIZE SOME OF THE 4407 03:15:52,600 --> 03:15:53,040 RISKS, AS NOTED SOME 4408 03:15:53,040 --> 03:15:53,640 MANUFACTURERS HAVE OFFERED TO 4409 03:15:53,640 --> 03:15:55,720 PROVIDE THE DEVICE RELATED 4410 03:15:55,720 --> 03:15:57,560 MAINTENANCE FOR PATIENTS 4411 03:15:57,560 --> 03:15:59,440 RESPONDING TO THE THERAPY, AND 4412 03:15:59,440 --> 03:16:02,160 AS WELL AS MANUFACTURE SUPPORT 4413 03:16:02,160 --> 03:16:11,760 FOR FILING COMPASSIONATE USE 4414 03:16:11,760 --> 03:16:14,400 EXEMPTIONS OR OTHER ACTIVITIES 4415 03:16:14,400 --> 03:16:15,040 TO HELP SUPPORT THOSE AREAS. AND 4416 03:16:15,040 --> 03:16:19,640 THEN ALL THE PLANS SHOULD REALLY 4417 03:16:19,640 --> 03:16:20,200 INCLUDE THOSE POST TRIAL 4418 03:16:20,200 --> 03:16:20,760 OBLIGATIONS AS WELL AS CAN 4419 03:16:20,760 --> 03:16:21,240 BUDGET FOR THE EXPENSES 4420 03:16:21,240 --> 03:16:23,680 ASSOCIATED WITH THAT GRANT 4421 03:16:23,680 --> 03:16:24,000 APPLICATION. 4422 03:16:24,000 --> 03:16:24,720 NEXT SLIDE. 4423 03:16:24,720 --> 03:16:26,360 SO COMMON ELEMENTS WE HAVE SEEN 4424 03:16:26,360 --> 03:16:28,160 OVER THE YEARS WITH VARIOUS 4425 03:16:28,160 --> 03:16:28,800 DIFFERENT ACTIVITIES. 4426 03:16:28,800 --> 03:16:31,240 AS MENTIONED THE DEVICE REMOVAL 4427 03:16:31,240 --> 03:16:32,760 AT THE END OF THE STUDY, THAT 4428 03:16:32,760 --> 03:16:35,080 CAN BE COVERED BY THE GRANT 4429 03:16:35,080 --> 03:16:37,920 FUNDS, POTENTIALLY DEVICE 4430 03:16:37,920 --> 03:16:39,360 REPLACEMENT AND SUBSEQUENT 4431 03:16:39,360 --> 03:16:41,320 PATIENT MONITORING, AND 4432 03:16:41,320 --> 03:16:42,880 POTENTIALLY ABLE TO BE COVERED 4433 03:16:42,880 --> 03:16:44,280 THROUGH INSURANCE MECHANISMS AND 4434 03:16:44,280 --> 03:16:45,840 GRANT FUNDS AS WELL. 4435 03:16:45,840 --> 03:16:47,760 THERE IS THE POSSIBILITY OF SOME 4436 03:16:47,760 --> 03:16:49,560 OF THEM PROPOSING CONTINUEDED 4437 03:16:49,560 --> 03:16:52,680 USE AFTER THE STUDY HAS ENDED. 4438 03:16:52,680 --> 03:16:54,520 BUT HAVING PLANS FOR REPAIRING 4439 03:16:54,520 --> 03:16:56,000 THE EXISTING HARDWARE AND 4440 03:16:56,000 --> 03:16:58,840 LOOKING AT ON GOING MONITORING, 4441 03:16:58,840 --> 03:17:03,040 AND MEDICAL SUPPORT ON GOING 4442 03:17:03,040 --> 03:17:04,640 COVERAGE, OR POTENTIALLY-TIME 4443 03:17:04,640 --> 03:17:05,000 HOSPITAL CARE. 4444 03:17:05,000 --> 03:17:08,840 SOME HAVE PROPOSED THE PURCHASE 4445 03:17:08,840 --> 03:17:09,440 DESIGNATED PRIVATE INSURANCE 4446 03:17:09,440 --> 03:17:12,120 PLAN SPECIFIC TO THOSE POST 4447 03:17:12,120 --> 03:17:12,760 TRIAL NEEDS. AS WE HEARD ABOUT 4448 03:17:12,760 --> 03:17:14,200 EARLIER TODAY, WE'VE SEEN THAT 4449 03:17:14,200 --> 03:17:14,760 THAT SUCCESSFULLY AND FROM 4450 03:17:14,760 --> 03:17:20,120 IMPLEMENTED OVERSEAS, BUT NOT SO 4451 03:17:20,120 --> 03:17:20,960 FAR IN THE US. 4452 03:17:20,960 --> 03:17:23,280 AND MOST OF THE PROPOSALS GIVE 4453 03:17:23,280 --> 03:17:25,800 THE PATIENTS THE OPTION TO 4454 03:17:25,800 --> 03:17:28,640 CONSIDER AT THE END OF THE STUDY 4455 03:17:28,640 --> 03:17:30,600 TO EITHER CONTINUE WITHIN ONE OF 4456 03:17:30,600 --> 03:17:31,920 THE VARIOUS DIFFERENT STRATEGIES 4457 03:17:31,920 --> 03:17:35,680 AND KEEP THE INVESTIGATIONAL 4458 03:17:35,680 --> 03:17:36,280 DEVICE EXEMPTION OPEN TO HELP 4459 03:17:36,280 --> 03:17:36,920 SUPPORT AND THOSE KIND OF LONGER 4460 03:17:36,920 --> 03:17:37,480 TERM FOLLOW UP TO, FOR THE 4461 03:17:37,480 --> 03:17:41,600 PATIENTS. IN SOME OF THE 4462 03:17:41,600 --> 03:17:42,560 INDICATIONS WHERE WE'RE 4463 03:17:42,560 --> 03:17:45,080 SUPPORTING PROJECTS THERE MAY BE 4464 03:17:45,080 --> 03:17:46,920 ALTERNATIVE TO CHANGE TO 4465 03:17:46,920 --> 03:17:47,800 COMMERCIALLY AVAILABLE DEVICE, 4466 03:17:47,800 --> 03:17:50,040 SO THERE AREN'T AS MANY CONCERNS 4467 03:17:50,040 --> 03:17:52,800 WITH THAT ONGOING CARE OF 4468 03:17:52,800 --> 03:17:54,440 RESEARCH DEVICE THAT'S BEEN 4469 03:17:54,440 --> 03:17:56,120 IMPLANTED AS PART OF THE STUDY. 4470 03:17:56,120 --> 03:17:57,960 IN SOME CASES THEY'RE GIVEN THE 4471 03:17:57,960 --> 03:18:00,200 OPTION TO 0 OUT THE DEVICE AND 4472 03:18:00,200 --> 03:18:03,120 TURN IT OFF, OR LEAVE IN PLACE. 4473 03:18:03,120 --> 03:18:05,960 OR AS MENTIONED THE EXPLANTATION 4474 03:18:05,960 --> 03:18:06,440 OPTION. 4475 03:18:06,440 --> 03:18:08,520 AND IN SOME CASES HOSPITALS HAVE 4476 03:18:08,520 --> 03:18:09,800 BEEN WILLING TO PROVIDE THAT 4477 03:18:09,800 --> 03:18:12,800 CARE IN PERPETUITY. 4478 03:18:12,800 --> 03:18:15,680 IN OTHER CASES THEY HAVE BEEN 4479 03:18:15,680 --> 03:18:18,120 LESS ENTHUSIASTIC OF THOSE TYPES 4480 03:18:18,120 --> 03:18:19,280 OF ACTIVITIES. 4481 03:18:19,280 --> 03:18:19,960 NEXT SLIDE. 4482 03:18:19,960 --> 03:18:21,560 I WAS GOING TO TALK A LITTLE 4483 03:18:21,560 --> 03:18:23,960 BIT ABOUT CMS OPTIONS, BUT WE 4484 03:18:23,960 --> 03:18:25,760 COVERED THOSE EARLIER, AND GO ON 4485 03:18:25,760 --> 03:18:28,720 TO THE NEXT SLIDE, NOW. 4486 03:18:28,720 --> 03:18:30,360 AND SO WHEN LOOKING AT MANAGING 4487 03:18:30,360 --> 03:18:33,000 THESE TYPES OF PROJECTS FROM A 4488 03:18:33,000 --> 03:18:34,440 PROGRAMMATIC STANDPOINT WE DO 4489 03:18:34,440 --> 03:18:36,200 HAVE SOME TOOLS AVAILABLE THAT 4490 03:18:36,200 --> 03:18:38,800 WE CAN USE AS NIH TO HELP 4491 03:18:38,800 --> 03:18:49,280 FACILITATE INVESTIGATORS 4492 03:18:50,880 --> 03:18:51,720 IMPLEMENTING THESE PLANS, ONE 4493 03:18:51,720 --> 03:18:52,360 ARE USING NO COST EXTENSION SO 4494 03:18:52,360 --> 03:18:53,840 WHERE THE INDIVIDUAL PROPOSAL 4495 03:18:53,840 --> 03:18:54,480 PERIOD MAY BE FOUR OR FIVE YEARS 4496 03:18:54,480 --> 03:18:55,120 THERE IS THAT POSSIBILITY FOR AT 4497 03:18:55,120 --> 03:18:59,760 THE END OF THE PROJECT. TO 4498 03:18:59,760 --> 03:19:00,360 REQUEST EITHER A FIRST, A NO 4499 03:19:00,360 --> 03:19:01,160 COST EXTENSION IS GENERALLY 4500 03:19:01,160 --> 03:19:02,360 AUTOMATIC. THERE'S A MANUAL 4501 03:19:02,360 --> 03:19:03,000 PROCESS BUT WE CAN DO A SECOND 4502 03:19:03,000 --> 03:19:07,200 NO COST EXTENSION, AND WE EVEN 4503 03:19:07,200 --> 03:19:07,800 HAD CASE HAVE HAD CASES WHERE 4504 03:19:07,800 --> 03:19:08,440 THE INVESTIGATORS SUCCESSFULLY 4505 03:19:08,440 --> 03:19:12,360 CAN PROPOSE A THIRD, NO COST 4506 03:19:12,360 --> 03:19:13,000 EXTENSION AT THE END WITH EACH 4507 03:19:13,000 --> 03:19:14,400 ONE OF THOSE BEING UP TO A YEAR 4508 03:19:14,400 --> 03:19:15,720 IN DURATION, THAT DOES PROVIDE 4509 03:19:15,720 --> 03:19:18,720 THE ABILITY TO EXTEND THE 4510 03:19:18,720 --> 03:19:21,080 OVERALL ACTIVE DIRECTORY PERIOD, 4511 03:19:21,080 --> 03:19:25,280 UP TO 3 YEARS, TO THE END OF THE 4512 03:19:25,280 --> 03:19:25,520 PROJECT. 4513 03:19:25,520 --> 03:19:27,400 AND BENEFIT OF BEING ABLE TO 4514 03:19:27,400 --> 03:19:31,040 EXTEND THE GRANT PERIOD KNOWING 4515 03:19:31,040 --> 03:19:32,880 THE CARRY OVER FUNDS FOR 4516 03:19:32,880 --> 03:19:35,080 EXPLOITATION OR UNEXPECTED 4517 03:19:35,080 --> 03:19:39,400 PATIENT COSTS CAN BE CARRIED 4518 03:19:39,400 --> 03:19:39,840 OVER TO WHEN NEEDED. 4519 03:19:39,840 --> 03:19:43,840 SO FOR EXAMPLE IF AN 4520 03:19:43,840 --> 03:19:44,480 INVESTIGATOR IN YEAR ONE OF THE 4521 03:19:44,480 --> 03:19:45,040 PROJECT IS PROPOSING HAS 4522 03:19:45,040 --> 03:19:47,600 BUDGETED IN HE POSSIBILITY FOR 4523 03:19:47,600 --> 03:19:51,720 THE PATIENT CHOOSING TO BE 4524 03:19:51,720 --> 03:19:55,200 EXPLANTED AT THE END OF THAT ONE 4525 03:19:55,200 --> 03:19:55,840 YEAR STUDY PERIOD IN THE PATIENT 4526 03:19:55,840 --> 03:19:56,480 FOR WHATEVER REASON DECIDES NOT 4527 03:19:56,480 --> 03:19:58,840 TO NECESSARILY BE EXPLANTED AT 4528 03:19:58,840 --> 03:20:03,720 THAT TIME, THOSE FUNDS CAN THEN 4529 03:20:03,720 --> 03:20:04,320 BE CARRIED OVER INTO FUTURE 4530 03:20:04,320 --> 03:20:06,680 YEARS FOR WHEN OR IF NEEDED. 4531 03:20:06,680 --> 03:20:07,280 WITH THAT ONGOING PATIENT AND 4532 03:20:07,280 --> 03:20:09,720 BEING ABLE TO APPLY THOSE FUNDS 4533 03:20:09,720 --> 03:20:11,720 TO SO THAT THE COSTS ARE NOT 4534 03:20:11,720 --> 03:20:12,280 NECESSARILY INCURRED BY THE 4535 03:20:12,280 --> 03:20:13,120 SUBJECT OR THE HOSPITAL. 4536 03:20:13,120 --> 03:20:14,400 SIMILARITY FOR UNEXPECTED EVENTS 4537 03:20:14,400 --> 03:20:17,400 IN THE PROJECT, WE CAN CONSIDER 4538 03:20:17,400 --> 03:20:19,720 ADMINISTRATIVE SUPPLEMENTS FOR 4539 03:20:19,720 --> 03:20:22,360 THOSE UNEXPECTED PATIENT CARE 4540 03:20:22,360 --> 03:20:23,360 EXPENSES AND POTENTIAL 4541 03:20:23,360 --> 03:20:24,040 ADDITIONAL FOLLOW-UP IF NEEDED 4542 03:20:24,040 --> 03:20:26,160 IN SOME OF THE PROJECTS THAT ARE 4543 03:20:26,160 --> 03:20:27,640 GOING WELL. 4544 03:20:27,640 --> 03:20:31,280 AND THEN THE OTHER OPTION THAT 4545 03:20:31,280 --> 03:20:34,560 I THINK HAS BEEN MENTIONEDED 4546 03:20:34,560 --> 03:20:43,760 EARLIER IS INVESTIGATORS 4547 03:20:43,760 --> 03:20:44,240 APPLYING FOR NEW GRANT 4548 03:20:44,240 --> 03:20:44,800 APPLICATIONS FOR LONG TERM 4549 03:20:44,800 --> 03:20:45,480 FOLLOW ON STUDIES, OR IF THERE'S 4550 03:20:45,480 --> 03:20:46,120 A NEW TECHNOLOGY ITERATION THAT 4551 03:20:46,120 --> 03:20:50,400 THEY'RE LOOKING AT PURSUING, 4552 03:20:50,400 --> 03:20:51,000 THEN THEY CAN APPLY FOR FUNDING 4553 03:20:51,000 --> 03:20:51,600 FOR THAT APPLICATION AND 4554 03:20:51,600 --> 03:20:52,240 DEPENDING UPON HOW THEY LINE UP 4555 03:20:52,240 --> 03:20:52,840 THEIR INCLUSION ENROLLMENT FOR 4556 03:20:52,840 --> 03:20:55,160 THE STUDY CAN RECRUIT PATIENTS 4557 03:20:55,160 --> 03:20:55,720 THAT MAY HAVE HAD THE PRIOR 4558 03:20:55,720 --> 03:20:59,720 VERSION OF THE TECHNOLOGY TO 4559 03:20:59,720 --> 03:21:00,320 ALLOW THEM TO UPGRADE TO THE 4560 03:21:00,320 --> 03:21:01,480 NEWEST VERSION THAT IS THEN 4561 03:21:01,480 --> 03:21:03,600 BEING SUPPORTED. 4562 03:21:03,600 --> 03:21:04,600 NEXT SLIDE. 4563 03:21:04,600 --> 03:21:06,520 SO, YOU KNOW, THERE IS A FEW OF 4564 03:21:06,520 --> 03:21:09,240 THE PROGRAMMATIC CHALLENGES TO 4565 03:21:09,240 --> 03:21:11,760 HIGHLIGHT THAT WE RUN INTO 4566 03:21:11,760 --> 03:21:13,400 ACROSS SEVERAL OF THESE VARIOUS 4567 03:21:13,400 --> 03:21:15,320 DIFFERENT AWARDS, AND MOST OF 4568 03:21:15,320 --> 03:21:16,760 THESE, YOU HAVE NOTED HAVE BEEN 4569 03:21:16,760 --> 03:21:18,760 BROUGHT UP OVER THE COURSE OF 4570 03:21:18,760 --> 03:21:18,960 TODAY. 4571 03:21:18,960 --> 03:21:20,600 THE FIRST, YOU KNOW, WHEN 4572 03:21:20,600 --> 03:21:23,360 LOOKING AT NIH, WE HAVE CONTROL 4573 03:21:23,360 --> 03:21:26,400 OF RELEASE OF FUNDS DURING 4574 03:21:26,400 --> 03:21:28,120 ACTIVE AWARD PERIODS. 4575 03:21:28,120 --> 03:21:30,760 ONCE THAT AWARD IS NO LONGER 4576 03:21:30,760 --> 03:21:32,200 ACTIVE WE NO LONGER HAVE THE 4577 03:21:32,200 --> 03:21:34,920 AUTHORITY OR ABILITY TO GIVE 4578 03:21:34,920 --> 03:21:36,080 ADDITIONAL FUNDS OR COVER 4579 03:21:36,080 --> 03:21:37,120 ACTIVITIES THAT ARE NOT 4580 03:21:37,120 --> 03:21:39,000 RELATED -- OR NOT WITHIN THAT 4581 03:21:39,000 --> 03:21:39,680 PROJECT PERIOD. 4582 03:21:39,680 --> 03:21:42,520 SO HENCE THE NOTE ABOUT USING 4583 03:21:42,520 --> 03:21:45,840 THE NO-COST EXTENSIONS TO CARRY 4584 03:21:45,840 --> 03:21:47,760 OVER SOME OF THOSE ADDITIONAL 4585 03:21:47,760 --> 03:21:48,360 FUNDS. 4586 03:21:48,360 --> 03:21:50,360 FOR ALMOST ALL OF THESE PROJECTS 4587 03:21:50,360 --> 03:21:53,240 ARE MILESTONE DRIVEN COOPERATIVE 4588 03:21:53,240 --> 03:21:55,400 AGREEMENTS WITH GO, NO-GO 4589 03:21:55,400 --> 03:21:57,600 DECISION POINTS THAT MAY BE 4590 03:21:57,600 --> 03:21:59,280 BASED ON EITHER SAFETY OUTCOMES 4591 03:21:59,280 --> 03:22:04,480 FOR THE STUDY, OR PRELIMINARY 4592 03:22:04,480 --> 03:22:06,200 EFFICACY DATA TO SHOW POTENTIAL 4593 03:22:06,200 --> 03:22:07,720 IMPROVEMENTS, IN THE STUDIES SO 4594 03:22:07,720 --> 03:22:11,640 FOR PROJECTS THAT FAIL TO MEET 4595 03:22:11,640 --> 03:22:16,680 THE MILESTONES, THE FUNDS FOR 4596 03:22:16,680 --> 03:22:17,280 THE PROJECT MAY BE REDUCED OR 4597 03:22:17,280 --> 03:22:19,240 DISCONTINUED, WHICH CAN ADD SOME 4598 03:22:19,240 --> 03:22:19,800 ADDITIONAL COMPLEXITY WHEN 4599 03:22:19,800 --> 03:22:20,360 LOOKING AT SOME OF THE POST 4600 03:22:20,360 --> 03:22:21,960 TRIAL OBLIGATIONS. THE VARIETY 4601 03:22:21,960 --> 03:22:22,600 OF OPTIONS THAT CAN HAPPEN WITH 4602 03:22:22,600 --> 03:22:24,880 THE INDUSTRY PARTNERS IN THESE 4603 03:22:24,880 --> 03:22:26,400 WHETHER THE COMPANY FILES FOR 4604 03:22:26,400 --> 03:22:27,000 BANKRUPTCY GOES COMPLETELY OUT 4605 03:22:27,000 --> 03:22:31,200 OF BUSINESS AS ACQUIRED OR 4606 03:22:31,200 --> 03:22:31,800 DECIDES TO NO LONGER PRODUCE THE 4607 03:22:31,800 --> 03:22:35,720 VERSION OF THE TECHNOLOGY 4608 03:22:35,720 --> 03:22:37,280 PRODUCED IN THE STUDY. 4609 03:22:37,280 --> 03:22:39,120 EACH ONE OF THOSE CAN CAUSE 4610 03:22:39,120 --> 03:22:40,680 INDIVIDUAL CHALLENGES AND 4611 03:22:40,680 --> 03:22:41,880 DIFFERENT SITUATIONS FOR THE 4612 03:22:41,880 --> 03:22:43,240 VARIOUS DIFFERENT PROJECTS. 4613 03:22:43,240 --> 03:22:45,680 FOURTH ON THE LIST THERE IS WHEN 4614 03:22:45,680 --> 03:22:48,320 THE PRINCIPAL INVESTIGATOR 4615 03:22:48,320 --> 03:22:51,760 CHANGES INSTITUTIONS OR DEPARTS 4616 03:22:51,760 --> 03:22:52,880 THE ACADEMIA ALL TOGETHER. 4617 03:22:52,880 --> 03:22:55,600 AND NOTED EARLIER TODAY, A LOT 4618 03:22:55,600 --> 03:22:58,640 OF THE TIES THE PATIENTS HAVE TO 4619 03:22:58,640 --> 03:23:00,240 THE STUDIES TO GO BACK TO THE 4620 03:23:00,240 --> 03:23:03,400 PHYSICIAN THAT IS RUNNING THE 4621 03:23:03,400 --> 03:23:05,080 CLINICAL TRIAL AND IF THEY'RE NO 4622 03:23:05,080 --> 03:23:07,040 LONGER ACCESSIBLE FOR THE STUDY, 4623 03:23:07,040 --> 03:23:08,840 THOSE CAN HAVE VARIOUS IMPACTS, 4624 03:23:08,840 --> 03:23:11,480 AND EACH ONE OF THE SITUATIONS 4625 03:23:11,480 --> 03:23:14,760 THAT COULD STAY WITH NEW PI AT 4626 03:23:14,760 --> 03:23:16,280 SAME INSTITUTION OR SOME CASES 4627 03:23:16,280 --> 03:23:17,680 THE AWARD CHANGES INSTITUTIONS 4628 03:23:17,680 --> 03:23:21,360 WHEN THE THE PI MOVES, WHICH CAN 4629 03:23:21,360 --> 03:23:23,040 DEFINITELY AFFECT THE PROPOSED 4630 03:23:23,040 --> 03:23:25,760 LONG TERM CARE PLANS, AND 4631 03:23:25,760 --> 03:23:26,360 SIMILARLY, WHILE THERE ARE 4632 03:23:26,360 --> 03:23:28,760 LETTERS OF SUPPORT IN THE 4633 03:23:28,760 --> 03:23:32,400 PROJECTS OR PLANS FROM A 4634 03:23:32,400 --> 03:23:34,000 UNIVERSITY PROVIDED SUPPORT, IF 4635 03:23:34,000 --> 03:23:35,880 THE UNIVERSITY LEADERSHIP 4636 03:23:35,880 --> 03:23:37,520 CHANGES, WHETHER THAT'S AT THE 4637 03:23:37,520 --> 03:23:42,880 DEPARTMENT LEVEL, ON UP THROUGH 4638 03:23:42,880 --> 03:23:45,000 TRANSFER, AND UNIVERSITY WIDE 4639 03:23:45,000 --> 03:23:46,920 POLICIES CAN THAT CAN CHANGE. 4640 03:23:46,920 --> 03:23:52,240 EVEN NOTED IN THE CASE OF OREGON 4641 03:23:52,240 --> 03:23:53,800 YOU CAN HAVE LAWS THAT CAN 4642 03:23:53,800 --> 03:23:55,680 CHANGE IN THE STATE THAT CAN 4643 03:23:55,680 --> 03:23:57,520 INFLUENCE SOME OF THOSE PLANS. 4644 03:23:57,520 --> 03:24:00,120 AND LAST POINT, IS THE PATIENT 4645 03:24:00,120 --> 03:24:02,200 DOES HAVE THE CHOICE TO EXPLANT 4646 03:24:02,200 --> 03:24:05,000 AT THE CONCLUSION OF THE STUDY. 4647 03:24:05,000 --> 03:24:11,720 NIH HAS NO INTERACTIONS WITH THE 4648 03:24:11,720 --> 03:24:12,280 PATIENT AND IS NOT PRIVY TO 4649 03:24:12,280 --> 03:24:12,920 WHICH INFORMATION IS SHARED WITH 4650 03:24:12,920 --> 03:24:13,560 THEM AS TO ENSURE THAT SOME OF 4651 03:24:13,560 --> 03:24:14,200 THESE OPTIONS AND THE FINANCIAL 4652 03:24:14,200 --> 03:24:16,720 IMPLICATIONS WITH THEM ARE FULLY 4653 03:24:16,720 --> 03:24:18,080 CONVEYED AS IT RELATES TO THE 4654 03:24:18,080 --> 03:24:19,280 MANAGEMENT OF THE GRANT AND 4655 03:24:19,280 --> 03:24:21,360 WHETHER OR NOT THOSE FUNDS COULD 4656 03:24:21,360 --> 03:24:22,480 POTENTIALLY BE AVAILABLE. 4657 03:24:22,480 --> 03:24:24,760 SO THAT'S THE END OF MY 4658 03:24:24,760 --> 03:24:26,400 PRESENTATION, HAPPY TO TAKE ANY 4659 03:24:26,400 --> 03:24:28,320 QUESTIONS, AND GO BACK TO 4660 03:24:28,320 --> 03:24:31,760 RHONDA, OR TURNOVER TO THE Q&A 4661 03:24:31,760 --> 03:24:32,800 PORTION OF THE PANEL. 4662 03:24:32,800 --> 03:24:38,400 >> YEAH, LET'S TAKE A QUESTION. 4663 03:24:38,400 --> 03:24:38,960 CHRISTINE, GO AHEAD, PLEASE. 4664 03:24:38,960 --> 03:24:40,200 >> THANK YOU, NICK. 4665 03:24:40,200 --> 03:24:42,600 I JUST WANTED TO ASK ONE 4666 03:24:42,600 --> 03:24:45,440 QUESTION ABOUT, YOU MENTIONED 4667 03:24:45,440 --> 03:24:47,000 THERE WAS AN OPTION OF 4668 03:24:47,000 --> 03:24:49,000 PURCHASING INSURANCE, BUT THAT 4669 03:24:49,000 --> 03:24:51,040 HAS HAPPENED IN OTHER COUNTRIES 4670 03:24:51,040 --> 03:24:53,560 AND NOT UNITED STATES. 4671 03:24:53,560 --> 03:24:56,200 ANY QUESTION ARE IS THAT WITH 4672 03:24:56,200 --> 03:24:58,400 NIH GRANT FUND, AND NUMBER ONE, 4673 03:24:58,400 --> 03:25:01,560 AND WHY NOT UNITED STATES, IS 4674 03:25:01,560 --> 03:25:02,520 THAT REGULATORY REASON OR JUST 4675 03:25:02,520 --> 03:25:04,160 HASN'T HAPPENED. 4676 03:25:04,160 --> 03:25:08,520 >> SO, I THINK IN TERMS OF THE 4677 03:25:08,520 --> 03:25:10,400 POLICIES AS TO WHETHER OR NOT 4678 03:25:10,400 --> 03:25:12,360 THAT'S ALLOWED WITH GRANT FUNDS, 4679 03:25:12,360 --> 03:25:14,200 IT SORT OF DEPENDS ON THE NATURE 4680 03:25:14,200 --> 03:25:15,880 OF HOW IT'S DESCRIBED IN THE 4681 03:25:15,880 --> 03:25:18,440 POLICY, AND GRANT APPLICATION, 4682 03:25:18,440 --> 03:25:21,640 WHETHER IT'S ALLOWABLE OR NOT: 4683 03:25:21,640 --> 03:25:23,920 IN THEORY, COULD BE -- AS LONG 4684 03:25:23,920 --> 03:25:25,800 AS JUSTIFIED TO THE RESEARCH 4685 03:25:25,800 --> 03:25:28,040 TOOLS OF THE STUDIES AND 4686 03:25:28,040 --> 03:25:28,480 ACCOMPLISHING THOSE. 4687 03:25:28,480 --> 03:25:30,400 THE CHALLENGE THAT INVESTIGATORS 4688 03:25:30,400 --> 03:25:33,000 HAVE FACED, AND IN PARTICULARLY 4689 03:25:33,000 --> 03:25:34,040 NOTED EARLIER. 4690 03:25:34,040 --> 03:25:36,240 YOU ARE SORT OF LOOKING AT 4691 03:25:36,240 --> 03:25:38,520 TRYING TO HAVE AN INSURANCE 4692 03:25:38,520 --> 03:25:40,560 POLICY IN AN AREA WHERE YOU ARE 4693 03:25:40,560 --> 03:25:43,480 DEALING WITH SMALL NUMBER OF 4694 03:25:43,480 --> 03:25:45,760 PATIENTS, THAT -- THE WAY MOST 4695 03:25:45,760 --> 03:25:47,320 INSURANCE WORKS IS MATTERS OF 4696 03:25:47,320 --> 03:25:49,120 SCALE, AND LOOKING TO TRY AND 4697 03:25:49,120 --> 03:25:52,880 SUPPORT A POLICY OF TRIAL OF 5, 4698 03:25:52,880 --> 03:25:55,240 10, 15 SUBJECTS, THE 4699 03:25:55,240 --> 03:25:56,920 INVESTIGATORS THAT HAVE TRIED TO 4700 03:25:56,920 --> 03:26:00,400 REACH OUT TO INSURERS, HAVE HAD 4701 03:26:00,400 --> 03:26:02,360 LIMITED SUCCESS IN GETTING THEM 4702 03:26:02,360 --> 03:26:04,440 TO SUPPORT AN ACTIVITY LIKE THAT 4703 03:26:04,440 --> 03:26:06,640 FROM A FINANCIAL STANDPOINT. 4704 03:26:06,640 --> 03:26:09,040 FROM COST BENEFIT RATIO. 4705 03:26:09,040 --> 03:26:11,360 DOESN'T MEAN THERE ISN'T AN 4706 03:26:11,360 --> 03:26:12,840 OPTION OUT THERE, AND OTHER 4707 03:26:12,840 --> 03:26:14,280 PROVIDERS THAT MAY BE INTERESTED 4708 03:26:14,280 --> 03:26:14,840 IN OPERATING IN THE SPACE. 4709 03:26:14,840 --> 03:26:19,440 >> THANK YOU. 4710 03:26:19,440 --> 03:26:21,520 >> THANKS, NICK. 4711 03:26:21,520 --> 03:26:23,720 LET'S -- RHONDA SHALL WE COME 4712 03:26:23,720 --> 03:26:25,120 BACK TO YOU. 4713 03:26:25,120 --> 03:26:26,080 I THINK YOU MAY HAVE HAD A 4714 03:26:26,080 --> 03:26:28,120 LITTLE BIT TO SAY BEFORE WE LOST 4715 03:26:28,120 --> 03:26:29,920 YOU AND LET YOU FINISH UP, AND 4716 03:26:29,920 --> 03:26:32,040 MOVE ON TO THE PANEL -- OR THE 4717 03:26:32,040 --> 03:26:32,440 DISCUSSION PART. 4718 03:26:32,440 --> 03:26:35,520 >> ALL RIGHT, LET ME ASK "CAN 4719 03:26:35,520 --> 03:26:36,800 YOU HEAR ME? 4720 03:26:36,800 --> 03:26:36,920 " 4721 03:26:36,920 --> 03:26:38,280 >> YES. 4722 03:26:38,280 --> 03:26:39,040 >> OKAY. 4723 03:26:39,040 --> 03:26:42,200 I DON'T... I REALLY APOLOGIZE 4724 03:26:42,200 --> 03:26:43,720 FOR THESE TERRIBLE TECHNOLOGY 4725 03:26:43,720 --> 03:26:44,080 PROBLEMS. 4726 03:26:44,080 --> 03:26:45,160 I DON'T KNOW WHERE I LEFT OFF. 4727 03:26:45,160 --> 03:26:46,440 BUT I HAVE BEEN ABLE TO HEAR THE 4728 03:26:46,440 --> 03:26:49,000 LAST PRESENTATION. 4729 03:26:49,000 --> 03:26:51,200 I THINK THE ONLY THING THAT I 4730 03:26:51,200 --> 03:26:54,160 WOULD WANT TO ADD TO THIS, IS 4731 03:26:54,160 --> 03:26:56,720 THE CONSIDERATION OF THE THINGS 4732 03:26:56,720 --> 03:26:59,440 THAT IN TALKING WITH COLLEAGUES 4733 03:26:59,440 --> 03:27:04,040 THAT SEEM TO BE DELIMITED AND 4734 03:27:04,040 --> 03:27:05,520 NEED TO BE ADDRESSED. 4735 03:27:05,520 --> 03:27:07,480 ONE OF THE MAJOR ONES WAS GOING 4736 03:27:07,480 --> 03:27:09,360 FROM WHAT I CALL INDIVIDUALLY 4737 03:27:09,360 --> 03:27:11,480 PROVEN TO POPULATION PROVEN. 4738 03:27:11,480 --> 03:27:13,720 AND THIS IS WHERE, I THINK THIS 4739 03:27:13,720 --> 03:27:18,680 QUESTION HAS COME UP AROUND 4740 03:27:18,680 --> 03:27:21,680 PROVID 4741 03:27:21,680 --> 03:27:26,400 PROVIDERS RESPONDING TO PATIENTS 4742 03:27:26,400 --> 03:27:29,600 WHO HAVE NEEDS THAT ARE NOT 4743 03:27:29,600 --> 03:27:32,400 BEING MET BY TECHNOLOGIES 4744 03:27:32,400 --> 03:27:33,240 CURRENT TECHNOLOGIES THAT ARE 4745 03:27:33,240 --> 03:27:33,520 OUT THERE. 4746 03:27:33,520 --> 03:27:38,960 AND BEGIN TO USE CERTAIN TYPES 4747 03:27:38,960 --> 03:27:39,720 OF TREATMENTS OFF LABEL AND IN 4748 03:27:39,720 --> 03:27:41,920 SOME CASES HAVE SEEN IMPROVEMENT 4749 03:27:41,920 --> 03:27:42,560 IN THOSE INDIVIDUALS WERE OTHER 4750 03:27:42,560 --> 03:27:43,160 GENERALS TREATMENTS HAVE NOT 4751 03:27:43,160 --> 03:27:47,920 BEEN SUCCESSFUL. THE ROAD FOR 4752 03:27:47,920 --> 03:27:48,520 THAT PARTICULAR JOURNEY TO GET 4753 03:27:48,520 --> 03:27:54,440 TO THE POINT OF BEING INSURANCE 4754 03:27:54,440 --> 03:27:55,000 COVERED IS VERY DIFFICULT. 4755 03:27:55,000 --> 03:27:59,720 BECAUSE OF THE FACT THAT 4756 03:27:59,720 --> 03:28:00,360 PROVIDERS GENERALLY DO NOT HAVE 4757 03:28:00,360 --> 03:28:01,000 ACCESS TO ENOUGH PATIENTS THAT 4758 03:28:01,000 --> 03:28:03,720 THEY ARE ABLE TO APPLY THIS 4759 03:28:03,720 --> 03:28:04,240 TECHNOLOGY UP LABEL, AND 4760 03:28:04,240 --> 03:28:04,880 THEREFORE, IT WILL NEVER REACH 4761 03:28:04,880 --> 03:28:08,920 THE LEVEL OF THRESHOLD FOR BEING 4762 03:28:08,920 --> 03:28:11,680 PROVEN, EVEN FOR OBSERVATION 4763 03:28:11,680 --> 03:28:13,720 SETTING THAT GENERALLY REQUIRES 4764 03:28:13,720 --> 03:28:18,600 AT LEAST 1000S OF PATIENTS TO BE 4765 03:28:18,600 --> 03:28:19,640 INVOLVED IN THAT. 4766 03:28:19,640 --> 03:28:20,440 I THINK THAT'S A VERY IMPORTANT 4767 03:28:20,440 --> 03:28:23,320 PIECE TO TAKE A LOOK AT. 4768 03:28:23,320 --> 03:28:26,400 MANY TIMES A PLAN WILL REVIEW AN 4769 03:28:26,400 --> 03:28:29,720 INDIVIDUAL WHO HAS HAD 4770 03:28:29,720 --> 03:28:31,720 DIFFICULTY TREATMENT RESISTANT 4771 03:28:31,720 --> 03:28:33,240 WHETHER IT'S DEPRESSION OR OTHER 4772 03:28:33,240 --> 03:28:34,920 TYPES OF CONDITIONS, WITH 4773 03:28:34,920 --> 03:28:36,360 CURRENT TREATMENTS AND WE'LL 4774 03:28:36,360 --> 03:28:38,400 REVIEW IT ON AN INDIVIDUAL 4775 03:28:38,400 --> 03:28:39,240 BASIS. 4776 03:28:39,240 --> 03:28:42,040 LOOKING FOR ALL THE DATA OF ALL 4777 03:28:42,040 --> 03:28:43,720 THE TREATMENTS RENDERED AND 4778 03:28:43,720 --> 03:28:46,560 MAKING SURE THE TREATMENTS WERE 4779 03:28:46,560 --> 03:28:50,120 RENDERED AT THE MOST EFFICACIOUS 4780 03:28:50,120 --> 03:28:51,560 DOSAGES AND LENGTH OF TIME AND 4781 03:28:51,560 --> 03:28:53,720 CAN MAKE AN INDIVIDUAL DECISION. 4782 03:28:53,720 --> 03:28:55,160 THOSE ARE DIFFICULT ISSUES 4783 03:28:55,160 --> 03:28:56,880 BECAUSE IT REQUIRES A LOT OF 4784 03:28:56,880 --> 03:28:59,040 DOCUMENTATION AND IT IS 4785 03:28:59,040 --> 03:29:01,200 DEPENDENT UPON THE CLINICAL 4786 03:29:01,200 --> 03:29:01,840 INTERPRETATION BY THE REVIEWER 4787 03:29:01,840 --> 03:29:04,560 IN THAT CASE. 4788 03:29:04,560 --> 03:29:05,880 SO TO ME IT SEEMS AS THOUGH THIS 4789 03:29:05,880 --> 03:29:07,240 IS ONE OF THE AREAS WHERE THERE 4790 03:29:07,240 --> 03:29:08,720 IS A NEED FOR POLICY, OR THERE 4791 03:29:08,720 --> 03:29:11,080 IS A NEED FOR PROCESS. 4792 03:29:11,080 --> 03:29:14,840 THE OTHER THING I MENTIONED WAS, 4793 03:29:14,840 --> 03:29:17,280 INCLUDING IN CLINICAL RESEARCH, 4794 03:29:17,280 --> 03:29:19,320 WHAT I CALL COMPARATIVE 4795 03:29:19,320 --> 03:29:20,400 RESEARCH, WHERE YOU ARE 4796 03:29:20,400 --> 03:29:23,240 COMPARING A NEW TECHNOLOGY, NOT 4797 03:29:23,240 --> 03:29:27,440 TO PLACEBO BUT OTHER EXISTING 4798 03:29:27,440 --> 03:29:28,960 TECHNOLOGIES, PARTICULARLY 4799 03:29:28,960 --> 03:29:30,360 THAT'S IMPORTANT BECAUSE ONE 4800 03:29:30,360 --> 03:29:32,080 WANTS TO UNDERSTAND IF A NEW 4801 03:29:32,080 --> 03:29:34,840 TECHNOLOGY IS COMING ON BOARD, 4802 03:29:34,840 --> 03:29:38,920 AND ITS EFFICACIOUS HOW WELL DID 4803 03:29:38,920 --> 03:29:40,000 IT WORK AGAINST WHAT IS ALREADY 4804 03:29:40,000 --> 03:29:40,480 OUT THERE. 4805 03:29:40,480 --> 03:29:42,640 AND TWO, TAKING A LOOK AT WHAT 4806 03:29:42,640 --> 03:29:44,400 MIGHT BE THE COST DIFFERENTIAL. 4807 03:29:44,400 --> 03:29:46,920 AND THIS IS HOW PAYERS WILL 4808 03:29:46,920 --> 03:29:48,520 THINK ABOUT THIS IN THAT REGARD. 4809 03:29:48,520 --> 03:29:49,360 AND I'LL STOP WITH THAT. 4810 03:29:49,360 --> 03:29:55,600 AND AGAIN, APOLOGIZE AGAIN FOR 4811 03:29:55,600 --> 03:29:56,240 THE TERRIBLE TECHNOLOGY ISSUES. 4812 03:29:56,240 --> 03:29:58,080 >> NO, NO, PROBLEM. 4813 03:29:58,080 --> 03:29:59,920 WE ARE GLAD WE COULD GET THAT 4814 03:29:59,920 --> 03:30:00,360 IN. 4815 03:30:00,360 --> 03:30:02,200 IT'S ALL VERY IMPORTANT 4816 03:30:02,200 --> 03:30:05,800 INFORMATION TO FOLD INTO THE 4817 03:30:05,800 --> 03:30:06,120 DISCUSSION. 4818 03:30:06,120 --> 03:30:07,480 ANY DIRECT QUESTIONS FOR DR. 4819 03:30:07,480 --> 03:30:17,760 ROBINSON BEALE? 4820 03:30:19,800 --> 03:30:20,480 SASKIA, YEAH, 4821 03:30:20,480 --> 03:30:22,160 >> I'LL GO AGAIN. 4822 03:30:22,160 --> 03:30:23,080 THANK YOU SO MUCH. 4823 03:30:23,080 --> 03:30:25,160 IN SOME OF THE PREMEETINGS WE 4824 03:30:25,160 --> 03:30:27,480 LEARNED A COUPLE OF INSTANCES 4825 03:30:27,480 --> 03:30:28,600 MAY GENERALLY BE COVERED BY 4826 03:30:28,600 --> 03:30:29,880 PRIVATE INSURANCE. 4827 03:30:29,880 --> 03:30:35,520 AND I JUST WANTED TO CHECK WITH 4828 03:30:35,520 --> 03:30:38,400 YOU IF YOU HAVE THE SAME 4829 03:30:38,400 --> 03:30:41,040 IMPRESSION, WE LEARNED THAT 4830 03:30:41,040 --> 03:30:42,480 THINGS INCLUDING EMERGENCY 4831 03:30:42,480 --> 03:30:46,720 MEDICAL CARE, RELATED TO A 4832 03:30:46,720 --> 03:30:49,040 DEVICE. 4833 03:30:49,040 --> 03:30:51,520 EXPLOITATION BECAUSE OF MEDICAL 4834 03:30:51,520 --> 03:30:51,800 INDICATION. 4835 03:30:51,800 --> 03:30:57,040 AND ROUTINE SERVICES THAT A 4836 03:30:57,040 --> 03:30:58,400 PATIENT WOULD HAVE REQUIRED 4837 03:30:58,400 --> 03:31:00,160 REGARDLESS OF THE EXPERIMENTAL 4838 03:31:00,160 --> 03:31:03,000 STATUS OF THE DEVICE. 4839 03:31:03,000 --> 03:31:04,680 THOSE ALL WOULD BE COVERED 4840 03:31:04,680 --> 03:31:06,920 GENERALLY SPEAKING BY PRIVATE 4841 03:31:06,920 --> 03:31:10,480 HEALTH INSURANCE INDEPENDENT OF 4842 03:31:10,480 --> 03:31:12,760 WHETHER A DEVICE HAS BEEN 4843 03:31:12,760 --> 03:31:13,800 COMMERCIALLY APPROVED FOR 4844 03:31:13,800 --> 03:31:14,360 CERTAINLY INDICATION. 4845 03:31:14,360 --> 03:31:17,280 IS THAT ABOUT RIGHT? 4846 03:31:17,280 --> 03:31:18,600 >> YES, THAT'S CORRECT. 4847 03:31:18,600 --> 03:31:22,120 I'M SORRY IN THE PART THAT GOT 4848 03:31:22,120 --> 03:31:27,720 BLANKED OUT I DID GO OVER THAT. 4849 03:31:27,720 --> 03:31:30,840 I DIDN'T KNOW WHETHER THAT WAS 4850 03:31:30,840 --> 03:31:31,240 HEARD. 4851 03:31:31,240 --> 03:31:35,040 ABSOLUTELY TRUE, MOST INSURERS I 4852 03:31:35,040 --> 03:31:37,680 TALKED TO INCLUDED THAT IN THEIR 4853 03:31:37,680 --> 03:31:38,400 PARTICULARLY COVERAGE. 4854 03:31:38,400 --> 03:31:43,960 IT KIND OF AGAIN POINTS TO AN 4855 03:31:43,960 --> 03:31:44,600 OPPORTUNITY AS NIH APPROACHES, 4856 03:31:44,600 --> 03:31:47,760 SENDING OUT RFIS RFPS OR 4857 03:31:47,760 --> 03:31:51,360 PARTICULAR TECHNOLOGY AS 4858 03:31:51,360 --> 03:31:55,720 PLANNING WORK WITH INSURERS SO 4859 03:31:55,720 --> 03:31:59,720 WE UNDERSTAND WHERE THERE MAY BE 4860 03:31:59,720 --> 03:31:59,920 GAPS. 4861 03:31:59,920 --> 03:32:04,320 PARTICULARLY IF ONE IS ABLE TO 4862 03:32:04,320 --> 03:32:04,920 PUT TOGETHER WHAT'S CALLED A 4863 03:32:04,920 --> 03:32:05,560 JOURNEY MAP OF WHAT A PATIENT'S 4864 03:32:05,560 --> 03:32:07,720 GOING TO BE EXPERIENCING IF THEY 4865 03:32:07,720 --> 03:32:08,320 TAKE PART IN THAT PARTICULAR 4866 03:32:08,320 --> 03:32:11,720 TECHNOLOGY. AND I THINK KNOWING 4867 03:32:11,720 --> 03:32:14,160 UPFRONT WHAT THE ISSUES ARE WILL 4868 03:32:14,160 --> 03:32:17,120 HELP INSURERS WORK WITH CLINICAL 4869 03:32:17,120 --> 03:32:19,360 TRIAL RESEARCHERS TO HELP CREATE 4870 03:32:19,360 --> 03:32:22,960 SOME CONSISTENCY AS MUCH AS 4871 03:32:22,960 --> 03:32:23,240 POSSIBLE. 4872 03:32:23,240 --> 03:32:24,480 GIVEN THE CURRENT RULES AND 4873 03:32:24,480 --> 03:32:26,360 POLICIES IN PLACE. 4874 03:32:26,360 --> 03:32:27,800 AND THEN, IDENTIFY WHERE THERE 4875 03:32:27,800 --> 03:32:29,600 IS NEED FOR NEW THINKING, AND 4876 03:32:29,600 --> 03:32:35,240 NEW PROBLEM-SOLVING. 4877 03:32:35,240 --> 03:32:36,200 >> GREAT, THANK YOU. 4878 03:32:36,200 --> 03:32:39,360 DID YOU HAVE A COMMENT TO THAT? 4879 03:32:39,360 --> 03:32:42,360 >> NO, ACTUALLY TO ALL OF THIS. 4880 03:32:42,360 --> 03:32:45,640 SO, WHAT I'M HEARING, IS THAT WE 4881 03:32:45,640 --> 03:32:48,480 HAVE THAT FDA PROCESS FOR 4882 03:32:48,480 --> 03:32:50,320 DECIDING WHETHER SOMETHING IS 4883 03:32:50,320 --> 03:32:52,640 SAFE AND EFFECTIVE. 4884 03:32:52,640 --> 03:32:55,680 CMS HAS THEIR PERSPECTIVE, THE 4885 03:32:55,680 --> 03:32:58,040 INSURERS HAVE THEIR PERSPECTIVE. 4886 03:32:58,040 --> 03:33:00,000 AND OF COURSE THE CONSUMER 4887 03:33:00,000 --> 03:33:03,280 COMMUNITY HAS THEIR PERSPECTIVE. 4888 03:33:03,280 --> 03:33:06,880 OFTEN HAS TO DO NOT WITH THE 4889 03:33:06,880 --> 03:33:08,640 PRIMARY END POINT OF STUDIES BUT 4890 03:33:08,640 --> 03:33:10,040 QUALITY OF LIFE. 4891 03:33:10,040 --> 03:33:13,480 AND THIS IS VERY INEFFICIENT 4892 03:33:13,480 --> 03:33:13,720 PROCESS. 4893 03:33:13,720 --> 03:33:18,800 SO IF YOU CONDUCT A TRIAL THAT 4894 03:33:18,800 --> 03:33:22,440 IS SATISFACTORY TO FDA IT MAY 4895 03:33:22,440 --> 03:33:28,960 NOT BE SATISFACTORY TO CMS AND 4896 03:33:28,960 --> 03:33:31,760 TO PRIVATE INSURERS. 4897 03:33:31,760 --> 03:33:34,440 AND THIS HAS TO BE RESOLVED. 4898 03:33:34,440 --> 03:33:36,720 AGAIN, GO BACK TO MY PERSONAL 4899 03:33:36,720 --> 03:33:38,800 EXPERIENCE, BECAUSE IT WAS VERY 4900 03:33:38,800 --> 03:33:39,040 POSITIVE. 4901 03:33:39,040 --> 03:33:41,360 SO WITH THIS DEVICE, WE ENGAGED 4902 03:33:41,360 --> 03:33:45,240 WITH CMS, AND MAJOR INSURERS, 4903 03:33:45,240 --> 03:33:47,720 AND BLUE CROSS, BLUE CHEELD TO 4904 03:33:47,720 --> 03:33:50,080 HAVE A CONVERSATION ABOUT WHAT 4905 03:33:50,080 --> 03:33:54,680 WOULD BE GOOD EVIDENCE. 4906 03:33:54,680 --> 03:33:56,720 WHAT WOULD BE SATISFACTORY, AND 4907 03:33:56,720 --> 03:33:58,480 DESIGNED A TRIAL TO BE ABLE TO 4908 03:33:58,480 --> 03:33:58,960 DO THAT. 4909 03:33:58,960 --> 03:34:00,560 AND THAT WORKED VERY WELL. 4910 03:34:00,560 --> 03:34:03,040 AND I THINK THAT ESPECIALLY FOR 4911 03:34:03,040 --> 03:34:04,000 THOSE WHO ARE DEVELOPING VERY 4912 03:34:04,000 --> 03:34:06,400 NOVEL OR INNOVATIVE DEVICES, 4913 03:34:06,400 --> 03:34:09,600 LIKE THE ONES THAT NICK IS 4914 03:34:09,600 --> 03:34:12,160 FUELING, THESE ARE INDIVIDUALS 4915 03:34:12,160 --> 03:34:15,440 WHO MAY NOT BE AS KNOWLEDGEABLE 4916 03:34:15,440 --> 03:34:17,280 ABOUT HOW THAT KIND OF ACTIVITY 4917 03:34:17,280 --> 03:34:19,360 HAS TO TAKE PLACE EARLIER. 4918 03:34:19,360 --> 03:34:20,760 THEY JUST DON'T HAVE THE 4919 03:34:20,760 --> 03:34:21,960 EXPERIENCE AND DON'T HAVE 4920 03:34:21,960 --> 03:34:23,400 REGULATORY, AND QUALITY. 4921 03:34:23,400 --> 03:34:25,880 AND SO MAYBE AS PART OF THE 4922 03:34:25,880 --> 03:34:29,160 CLINICAL TRIAL ENTERPRISE, THERE 4923 03:34:29,160 --> 03:34:29,960 COULD BE SOME TYPE OF EDUCATION 4924 03:34:29,960 --> 03:34:35,440 TRAINING OR ENCOURAGEMENT AS 4925 03:34:35,440 --> 03:34:36,040 THESE TRIALS ARE DESIGNED TO 4926 03:34:36,040 --> 03:34:39,360 CONSIDER WHAT NEEDS TO BE ON THE 4927 03:34:39,360 --> 03:34:41,280 OTHER END. 4928 03:34:41,280 --> 03:34:43,720 THE OTHER END IS PROBABLY NOT 4929 03:34:43,720 --> 03:34:45,200 FDA APPROVAL. 4930 03:34:45,200 --> 03:34:48,240 BUT MAYBE THE KIND OF DATA, THAT 4931 03:34:48,240 --> 03:34:51,240 WOULD BE ACCEPTED WORTHY OF 4932 03:34:51,240 --> 03:34:55,280 GOING ON A FEASIBILITY STUDY OR 4933 03:34:55,280 --> 03:34:55,720 PIFRTAL STUDY. 4934 03:34:55,720 --> 03:34:58,680 I FEEL IF EVERYBODY IS MORE 4935 03:34:58,680 --> 03:35:00,680 INVESTED ON WHAT IS HAPPENING UP 4936 03:35:00,680 --> 03:35:03,440 FRONT, WILL BE EASIER TO BE 4937 03:35:03,440 --> 03:35:04,960 INVESTED AFTER THE STUDY IS 4938 03:35:04,960 --> 03:35:08,760 DONE. 4939 03:35:08,760 --> 03:35:11,120 >> THAT'S A GREAT POINT. 4940 03:35:11,120 --> 03:35:12,680 I THINK FOR NOW, IN THE 4941 03:35:12,680 --> 03:35:14,040 DISCUSSION PORTION OF THIS, 4942 03:35:14,040 --> 03:35:16,360 WHICH IS EXACTLY WHERE WE SHOULD 4943 03:35:16,360 --> 03:35:25,440 BE AT THIS POINT, LET'S -- MARTY 4944 03:35:25,440 --> 03:35:29,640 IF I MAY, SAY A FEW FRAMING 4945 03:35:29,640 --> 03:35:31,720 COMMENTS AND THEN PICK UP RIGHT 4946 03:35:31,720 --> 03:35:33,760 WHERE YOU HAVE US. 4947 03:35:33,760 --> 03:35:35,400 REMEMBER THIS PANEL -- THE FIRST 4948 03:35:35,400 --> 03:35:36,720 PANEL WAS ABOUT ISSUES THAT WE 4949 03:35:36,720 --> 03:35:37,480 NEED TO FIX. 4950 03:35:37,480 --> 03:35:40,200 THE PANEL IS ABOUT WHAT IS 4951 03:35:40,200 --> 03:35:41,840 ALREADY BEING COVERED VERSUS 4952 03:35:41,840 --> 03:35:42,080 NOT. 4953 03:35:42,080 --> 03:35:43,880 AND WE OBVIOUSLY HEARD A LOT OF 4954 03:35:43,880 --> 03:35:45,400 PERSPECTIVES ON THIS. 4955 03:35:45,400 --> 03:35:48,960 AND CAN ASK TO FRAME THE WHOLE 4956 03:35:48,960 --> 03:35:51,400 DISCUSSION WITH NEUROLOGICAL 4957 03:35:51,400 --> 03:35:53,960 FOUNDATION, AND CONSIDER RESPECT 4958 03:35:53,960 --> 03:35:56,320 TO PERSONS AND ALL THE THINGS 4959 03:35:56,320 --> 03:35:59,720 YOU BILLED ALL THESE PRACTICAL 4960 03:35:59,720 --> 03:36:00,040 APPROACHES. 4961 03:36:00,040 --> 03:36:02,400 AND THE SPIRIT OF BEING 4962 03:36:02,400 --> 03:36:04,240 PRACTICAL, LET'S DO SO. 4963 03:36:04,240 --> 03:36:06,560 AND I WAS GOING TO SUGGEST 4964 03:36:06,560 --> 03:36:08,760 MARTY, THAT WE START WITH THE 4965 03:36:08,760 --> 03:36:09,520 EXAMPLE YOU GAVE. 4966 03:36:09,520 --> 03:36:20,080 WITH YOUR LGS TRIAL, WHERE IT'S 4967 03:36:22,960 --> 03:36:23,520 DEMOCRATIZED SORT OF DIVIDE AND 4968 03:36:23,520 --> 03:36:26,440 CONQUER APPROACH, WHERE THE 4969 03:36:26,440 --> 03:36:27,080 DEVICE MANUFACTURER THE PAYER, 4970 03:36:27,080 --> 03:36:27,680 WHETHER IT'S GOVERNMENT OR A 4971 03:36:27,680 --> 03:36:32,400 PRIVATE INSURANCE COMPANY, 4972 03:36:32,400 --> 03:36:34,040 HEALTH CARE SYSTEM, 4973 03:36:34,040 --> 03:36:35,160 INVESTIGATOR, THE PATIENT, 4974 03:36:35,160 --> 03:36:39,000 FEDERAL SPONSOR, OF THE GRANT, 4975 03:36:39,000 --> 03:36:41,080 YOU KNOW ALL HAVE PIECE OF 4976 03:36:41,080 --> 03:36:42,680 BURDEN, AND PRICE TO PAY. 4977 03:36:42,680 --> 03:36:45,320 AND I WONDER IF WE CAN START 4978 03:36:45,320 --> 03:36:47,880 WITH THAT AS A RUBRIC THAT WE 4979 03:36:47,880 --> 03:36:51,720 CAN EITHER CONTINUE TO ACCEPT 4980 03:36:51,720 --> 03:36:55,480 AND WIDDLE, OR, YOU KNOW, DECIDE 4981 03:36:55,480 --> 03:36:57,360 ON -- THIS DOESN'T WORK AT ALL. 4982 03:36:57,360 --> 03:36:59,640 I WOULD LOVE TO HEAR FROM THE 4983 03:36:59,640 --> 03:37:01,680 VARIOUS REPRESENTATIVES IN 4984 03:37:01,680 --> 03:37:03,720 INVOLVED WHETHER THIS IS A 4985 03:37:03,720 --> 03:37:07,960 RUBRIC THAT COULD WORK. 4986 03:37:07,960 --> 03:37:11,040 YOU KNOW, THE COSTS ARE LARGE, 4987 03:37:11,040 --> 03:37:13,760 AND TRIALS ARE EXPENSIVE. 4988 03:37:13,760 --> 03:37:19,080 DOES THE DIVIDE AND CONQUER 4989 03:37:19,080 --> 03:37:23,760 APPROACH MAKE SENSE FROM THE 4990 03:37:23,760 --> 03:37:24,360 PERSPECTIVE OF THE VARIOUS 4991 03:37:24,360 --> 03:37:24,960 INDIVIDUALS AND STAKEHOLDERS 4992 03:37:24,960 --> 03:37:26,920 REPRESENTED HERE. . 4993 03:37:26,920 --> 03:37:29,600 >> LET ME JUST ADD, THE COSTS 4994 03:37:29,600 --> 03:37:31,600 COULD BE NORMAL. 4995 03:37:31,600 --> 03:37:32,640 BUT IF EVERYTHING WENT WRONG, 4996 03:37:32,640 --> 03:37:34,720 AND THE STUFF THAT WE TALKED 4997 03:37:34,720 --> 03:37:35,800 ABOUT COULD HAPPEN. 4998 03:37:35,800 --> 03:37:39,320 HIGHLY UNLIKELY, YOU CAN'T 4999 03:37:39,320 --> 03:37:39,640 ANTICIPATE. 5000 03:37:39,640 --> 03:37:41,120 WHAT THEN. 5001 03:37:41,120 --> 03:37:42,960 AND SO TALKING TO COMPANIES TO 5002 03:37:42,960 --> 03:37:45,400 CONSIDER OUT OF THE BOX 5003 03:37:45,400 --> 03:37:48,840 INSURANCE POLICIES, AND I HAD 5004 03:37:48,840 --> 03:37:50,680 ONE COMMENT FROM CARL THAT IT'S 5005 03:37:50,680 --> 03:37:53,120 SO HARD TO CALCULATE. 5006 03:37:53,120 --> 03:37:54,840 IT'S PROBABLY NOT GOING TO BE 5007 03:37:54,840 --> 03:37:56,320 MUCH OF ANYTHING. 5008 03:37:56,320 --> 03:37:59,200 BUT, IT COULD BE SOMETHING VERY 5009 03:37:59,200 --> 03:37:59,440 LARGE. 5010 03:37:59,440 --> 03:38:02,000 AND BECAUSE THESE ARE TRIALS, 5011 03:38:02,000 --> 03:38:03,720 THERE IS SO MUCH UNKNOWN. 5012 03:38:03,720 --> 03:38:06,240 AND SO IT'S VERY DIFFICULT TO 5013 03:38:06,240 --> 03:38:11,360 HAVE ANY KIND OF COMPETENT 5014 03:38:11,360 --> 03:38:19,720 EQUATION OF RISK. 5015 03:38:19,720 --> 03:38:22,680 >> SO LET ME BE SPECIFIC TO GET 5016 03:38:22,680 --> 03:38:22,920 STARTED. 5017 03:38:22,920 --> 03:38:24,360 CARL, THANK YOU FOR THE 5018 03:38:24,360 --> 03:38:25,320 PRESENTATION, I THINK THE 5019 03:38:25,320 --> 03:38:28,120 EXAMPLE OF CED WAS A VERY 5020 03:38:28,120 --> 03:38:28,560 ILLUMINATING ONE. 5021 03:38:28,560 --> 03:38:31,680 ANOTHER ONE THAT I WONDER WOULD 5022 03:38:31,680 --> 03:38:34,720 BE RELATED TO THE SITUATIONS WE 5023 03:38:34,720 --> 03:38:36,640 HAVE HERE OFTENTIMES IS THIS: 5024 03:38:36,640 --> 03:38:39,000 WHICH IS THAT, THERE IS A TRIAL 5025 03:38:39,000 --> 03:38:43,040 FUNDED, AND FEDERALLY FUNDED. 5026 03:38:43,040 --> 03:38:45,160 AND IT'S A SIGNIFICANT RISK 5027 03:38:45,160 --> 03:38:46,920 DEVICE, AND HAS AN IDE APPROVAL 5028 03:38:46,920 --> 03:38:49,000 FROM THE FDA. 5029 03:38:49,000 --> 03:38:51,440 WHAT ARE THE MECHANISMS BY 5030 03:38:51,440 --> 03:38:55,960 WHICH CMS WOULD ASSIST WITH 5031 03:38:55,960 --> 03:38:59,320 COVERING THE COSTS OF, LET'S SAY 5032 03:38:59,320 --> 03:39:02,160 DEVICE REPLACEMENT YEARS LATER 5033 03:39:02,160 --> 03:39:05,200 AFTER THE PATIENT WAS DONE WITH 5034 03:39:05,200 --> 03:39:08,120 THE TRIAL, SUPPOSE THE 5035 03:39:08,120 --> 03:39:10,240 MANUFACTURER IS WILLING TO 5036 03:39:10,240 --> 03:39:14,840 DONATE THE DEVICE, AND THE P 5037 03:39:14,840 --> 03:39:24,040 PATIENT DOESN'T HAVE PRIVATE 5038 03:39:24,040 --> 03:39:24,640 INSURANCE THAT WILL COVER THE 5039 03:39:24,640 --> 03:39:25,240 COST OF THE JUST THE SURGICAL 5040 03:39:25,240 --> 03:39:29,960 CARE, THE HOSPITAL CARE. WHAT 5041 03:39:29,960 --> 03:39:31,720 DOES CMS ABLE TO DO IN THAT 5042 03:39:31,720 --> 03:39:35,760 INSTANCE. . 5043 03:39:35,760 --> 03:39:38,400 >> AGAIN, IT'S A LOT OF IT 5044 03:39:38,400 --> 03:39:38,960 DEPENDS ON YOUR SITUATION, 5045 03:39:38,960 --> 03:39:44,160 BECAUSE EVERYBODY'S I WOULD 5046 03:39:44,160 --> 03:39:44,800 ACTUALLY WANT TO KIND OF MAYBE 5047 03:39:44,800 --> 03:39:45,400 BACKTRACK A LITTLE BIT AND I 5048 03:39:45,400 --> 03:39:46,000 KNOW ONE OF THE SLIDES THAT I 5049 03:39:46,000 --> 03:39:46,640 THINK THE LAST PRESENTER PUT UP 5050 03:39:46,640 --> 03:39:55,120 TO AND YOU JUST DISCUSSED IT I 5051 03:39:55,120 --> 03:39:55,760 WANT TO SAY THAT IT HAPPENS TO 5052 03:39:55,760 --> 03:39:56,360 BE MY GROUP BY SELF DIRECTED 5053 03:39:56,360 --> 03:39:59,720 COLLECTION WERE INVOLVED WORKING 5054 03:39:59,720 --> 03:40:00,280 WITH THE FDA ON THESE IDE 5055 03:40:00,280 --> 03:40:01,360 SWITCHES, WHICH MEANS DEVICE FOR 5056 03:40:01,360 --> 03:40:02,000 THE EARLIEST STAGE OF APPROVAL 5057 03:40:02,000 --> 03:40:02,600 THROUGH THE FDA. AND SO, CMS 5058 03:40:02,600 --> 03:40:06,680 HELPS TO MAKES COMMENTS ON THE 5059 03:40:06,680 --> 03:40:08,160 CLINICAL TRIALS GOING ON THERE, 5060 03:40:08,160 --> 03:40:09,880 EARLY FEASIBILITY STUDIES AND 5061 03:40:09,880 --> 03:40:11,360 MAKE SURE THE EVIDENCE COLLECTED 5062 03:40:11,360 --> 03:40:14,720 IN THE EARLY FEASIBILITY STUDY 5063 03:40:14,720 --> 03:40:17,280 HELPS PROVIDE EVIDENCE THAT CMS 5064 03:40:17,280 --> 03:40:19,440 COULD THEN REVIEW TO DETERMINE 5065 03:40:19,440 --> 03:40:20,520 WHETHER OR NOT SHOULD CONTINUE 5066 03:40:20,520 --> 03:40:23,800 TO PROVIDE COVERAGE. 5067 03:40:23,800 --> 03:40:25,640 EVEN AFTER PIVOT TRIAL. 5068 03:40:25,640 --> 03:40:28,400 SO WE WERE INVOLVED EARLY ON. 5069 03:40:28,400 --> 03:40:31,720 NOW, IF THAT EVIDENCE LEADS TO 5070 03:40:31,720 --> 03:40:33,600 NATIONAL COVERAGE DETERMINATION 5071 03:40:33,600 --> 03:40:35,880 OF THE SPONSOR REQUESTS NATIONAL 5072 03:40:35,880 --> 03:40:38,160 COVERAGE DETERMINATION, AFTER 5073 03:40:38,160 --> 03:40:41,280 THE IDE, ALSO COMES INTO THE 5074 03:40:41,280 --> 03:40:42,840 PLAY. 5075 03:40:42,840 --> 03:40:43,160 BEING THAT. 5076 03:40:43,160 --> 03:40:46,320 IF THERE IS ENOUGH EVIDENCE THAT 5077 03:40:46,320 --> 03:40:48,040 DEVICE SHOULD BE COVERED. 5078 03:40:48,040 --> 03:40:52,080 THE DEVICE AND EVIDENCE FOR MOB 5079 03:40:52,080 --> 03:40:53,880 CLINICAL TRIALS. 5080 03:40:53,880 --> 03:40:56,760 AND OBSERVATIONAL STUDIES THAT 5081 03:40:56,760 --> 03:41:00,880 HAVE OCCURRED, AGENCY WILL COVER 5082 03:41:00,880 --> 03:41:03,720 DEVICE AND ROUTINE SERVICES FROM 5083 03:41:03,720 --> 03:41:05,160 THAT POINT FORWARD. 5084 03:41:05,160 --> 03:41:07,040 AND ONCE THE NCD HAS GONE 5085 03:41:07,040 --> 03:41:10,520 THROUGH THE PROCESS, AND 5086 03:41:10,520 --> 03:41:11,120 APPROVED, AGENTS THEN SHOULD 5087 03:41:11,120 --> 03:41:11,920 COVER IT. 5088 03:41:11,920 --> 03:41:14,280 SO IT'S A LONG PROCESS. 5089 03:41:14,280 --> 03:41:17,200 >> WHAT ABOUT EARLIER IN 5090 03:41:17,200 --> 03:41:19,720 PROCESS, THERE IS QUESTION BY 5091 03:41:19,720 --> 03:41:25,000 APHONNOWS ATTENDEE. 5092 03:41:25,000 --> 03:41:26,440 2:47 SEN RAL TIME ANYWAY IF 5093 03:41:26,440 --> 03:41:28,320 PEOPLE WANT TO CHECK THE Q&A. 5094 03:41:28,320 --> 03:41:31,400 AND I'LL JUST PARAPHRASE AN IDE 5095 03:41:31,400 --> 03:41:34,040 STUDY OFTENTIMES, BY DEFINITION, 5096 03:41:34,040 --> 03:41:35,520 EARLY IN THE PROCESS. 5097 03:41:35,520 --> 03:41:37,040 AND SO NOT GOING TO BE EVIDENCE 5098 03:41:37,040 --> 03:41:41,760 OF EFFICACY OF THAT DEVICE. 5099 03:41:41,760 --> 03:41:52,240 AND MARTY HAS YOU SAID, WE 5100 03:41:59,800 --> 03:42:00,280 SHOULDN'T ENTER INTO THESE 5101 03:42:00,280 --> 03:42:00,880 THINGS PERHAPS WITHOUT HAVING 5102 03:42:00,880 --> 03:42:01,440 THOUGHT ABOUT THEM AHEAD OF 5103 03:42:01,440 --> 03:42:03,640 TIME. DISCIPLINARY APPROACH, 5104 03:42:03,640 --> 03:42:04,240 RIGHT. SO WE SHOULDN'T START 5105 03:42:04,240 --> 03:42:08,400 TRIALS WITHOUT HAVING SOME SENSE 5106 03:42:08,400 --> 03:42:11,080 OF OF HOW THEY'RE GONNA GO WITH 5107 03:42:11,080 --> 03:42:11,720 AN IDE WE DON'T HAVE WE'RE NOT 5108 03:42:11,720 --> 03:42:12,280 GOING TO HAVE THE EVIDENCE 5109 03:42:12,280 --> 03:42:12,920 SUGGESTING THE SHOWING EFFICACY 5110 03:42:12,920 --> 03:42:13,560 AND SO WE WOULD, WE WOULD HAVE 5111 03:42:13,560 --> 03:42:14,400 TO ENTER THAT WITHOUT THE 5112 03:42:14,400 --> 03:42:14,920 EVIDENCE, BUT THE PATIENT 5113 03:42:14,920 --> 03:42:18,720 PARTICIPANT WILL HAVE TO KNOW 5114 03:42:18,720 --> 03:42:19,360 WHAT IS GOING TO HAPPEN WITH 5115 03:42:19,360 --> 03:42:19,960 THEM AFTER THEY LEAVE THE TRIAL 5116 03:42:19,960 --> 03:42:20,600 WAS REALLY BEFORE THERE'S ENOUGH 5117 03:42:20,600 --> 03:42:21,240 EVIDENCE FOR AN NCD ETC. WHAT 5118 03:42:21,240 --> 03:42:21,760 ABOUT THAT SITUATION. 5119 03:42:21,760 --> 03:42:23,000 SO -- THAT'S A WHOLE ANOTHER 5120 03:42:23,000 --> 03:42:23,960 PRESENTATION, I DID NOT -- I 5121 03:42:23,960 --> 03:42:26,200 HAVE THE SLIDE, BUT NOT GOING TO 5122 03:42:26,200 --> 03:42:29,240 PUT YOU THROUGH THAT. 5123 03:42:29,240 --> 03:42:31,200 DURING THAT ID PROCESS. 5124 03:42:31,200 --> 03:42:34,440 WE WORK CLOSELY WITH FDA. 5125 03:42:34,440 --> 03:42:38,440 THE POINT IS WE ACTUALLY... WE 5126 03:42:38,440 --> 03:42:42,000 ARE WILLING TO ACCEPT A LOT 5127 03:42:42,000 --> 03:42:44,360 DETAIL, BUT SEEN SAMPLE SIZE OF 5128 03:42:44,360 --> 03:42:50,400 5 THAT SHOWS EFFICACY, AND NO 5129 03:42:50,400 --> 03:42:52,240 HARMS, AND BENEFITS OUTWAY THE 5130 03:42:52,240 --> 03:42:59,720 HARMS, AND WILL ACTUALLY PROVIDE 5131 03:42:59,720 --> 03:43:00,360 COVERAGE FOR THE DEVICE AND THE 5132 03:43:00,360 --> 03:43:02,400 RELATED SERVICES, EVEN AT THAT 5133 03:43:02,400 --> 03:43:03,040 EARLY STAGE SO DURING THE EARLY 5134 03:43:03,040 --> 03:43:07,720 FEASIBILITY STUDY, I MEAN, THE 5135 03:43:07,720 --> 03:43:08,360 FDA CLEARED IT. AND, YOU KNOW, 5136 03:43:08,360 --> 03:43:09,000 BELIEVES THAT THE, YOU KNOW, 5137 03:43:09,000 --> 03:43:09,520 AGAIN, THE BENEFITS. THE 5138 03:43:09,520 --> 03:43:10,160 BENEFITS OUTWEIGH THE HARMS ARE 5139 03:43:10,160 --> 03:43:13,680 WILLING TO PROVIDE COVERAGE FOR 5140 03:43:13,680 --> 03:43:14,280 THE DEVICE AND SERVICES EVEN 5141 03:43:14,280 --> 03:43:18,440 DURING THE EARLY FEASIBILITY 5142 03:43:18,440 --> 03:43:20,520 STUDY DURING THE ID PROCESS. 5143 03:43:20,520 --> 03:43:24,400 SO, AGAIN IT DEPENDS ON THE 5144 03:43:24,400 --> 03:43:26,400 EVIDENCE, BUT WE UNDERSTAND THAT 5145 03:43:26,400 --> 03:43:30,960 VERY EARLY IN THE FDA APPROVAL 5146 03:43:30,960 --> 03:43:31,560 PROCESS, THERE MIGHT BE VERY 5147 03:43:31,560 --> 03:43:32,160 LITTLE EVIDENCE BUT WE DO -- 5148 03:43:32,160 --> 03:43:33,960 DON'T WANT TO SAY REQUIRE -- BUT 5149 03:43:33,960 --> 03:43:35,600 WE'RE INTERESTED IN LOOKING AT 5150 03:43:35,600 --> 03:43:38,400 INTERNATIONAL STUDIES OF SAMPLE 5151 03:43:38,400 --> 03:43:41,560 SIZE OF 5. 5152 03:43:41,560 --> 03:43:43,720 AND PERHAPS THE EVIDENCE THERE 5153 03:43:43,720 --> 03:43:47,720 IS PROMISING, AND WILLING TO 5154 03:43:47,720 --> 03:43:52,800 TAKE THAT UP AS AS EVIDENCE OF 5155 03:43:52,800 --> 03:43:55,720 POTENTIAL EFFICACY OF THE DEVICE 5156 03:43:55,720 --> 03:43:56,400 AT THAT EARLY STAGE . 5157 03:43:56,400 --> 03:43:59,520 >> MARTY IS THAT A FRESH RAISED 5158 03:43:59,520 --> 03:43:59,720 HAND. 5159 03:43:59,720 --> 03:44:02,800 >> NO, PROBABLY AN OLD ONE, BUT 5160 03:44:02,800 --> 03:44:04,560 I WAS GOING TO RAISE MY HAND. 5161 03:44:04,560 --> 03:44:06,480 SO THAT'S AN EFFICIENT HAND. 5162 03:44:06,480 --> 03:44:08,960 I'LL TAKE MY HAND DOWN. 5163 03:44:08,960 --> 03:44:13,440 DR. LI, I WOULD LIKE TO SAY, 5164 03:44:13,440 --> 03:44:19,120 POLICY THAT CMS HAS FOR COVERING 5165 03:44:19,120 --> 03:44:19,720 INVESTIGATIONAL TRIALS UNDER 5166 03:44:19,720 --> 03:44:21,000 THESE CIRCUMSTANCES THAT YOU 5167 03:44:21,000 --> 03:44:26,840 JUST OULTED, AND NOW MEDICAID, I 5168 03:44:26,840 --> 03:44:29,160 UNDERSTAND THAT CONGRESS ENABLED 5169 03:44:29,160 --> 03:44:31,160 THAT A COUPLE MONTHS AGO IS ONE 5170 03:44:31,160 --> 03:44:33,280 OF THE REASONS WHY THINGS ARE 5171 03:44:33,280 --> 03:44:36,480 HANG IN UNITED STATES, AND IT'S 5172 03:44:36,480 --> 03:44:47,000 ALSO PROVIDINGS GUARANTEESES 5173 03:44:50,480 --> 03:44:51,040 THAT STUDIES ARE WELL THOUGHT 5174 03:44:51,040 --> 03:44:51,640 OUT AND SCIENTIFICALLY BALANCED 5175 03:44:51,640 --> 03:44:52,240 AND THAT THE ENDPOINTS ARE 5176 03:44:52,240 --> 03:44:59,480 MEANINGFUL JUSTIFIABLE. AND SO 5177 03:44:59,480 --> 03:45:00,120 BUT WE GET IN THE SAME PLACE AS 5178 03:45:00,120 --> 03:45:00,720 IT WANTS TO STUDIES DONE WHAT 5179 03:45:00,720 --> 03:45:03,000 HAPPENS TO THE PATIENT. AND THIS 5180 03:45:03,000 --> 03:45:03,600 IS, YOU KNOW I THINK UPFRONT, 5181 03:45:03,600 --> 03:45:04,240 WE'RE ALL ACTUALLY DOING REALLY 5182 03:45:04,240 --> 03:45:08,400 WELL. WE HAVE NIH THAT'S DOING 5183 03:45:08,400 --> 03:45:09,040 EXTRAORDINARY WORK THROUGH, FROM 5184 03:45:09,040 --> 03:45:09,560 MY PERSPECTIVE THE BRAIN 5185 03:45:09,560 --> 03:45:11,200 INITIATIVE AND THE PUBLIC 5186 03:45:11,200 --> 03:45:11,800 PRIVATE PARTNERSHIP WHICH IS 5187 03:45:11,800 --> 03:45:12,400 REALLY QUITE INNOVATIVE, AND 5188 03:45:12,400 --> 03:45:15,880 THAT'S REALLY EFFECTIVE. WE HAVE 5189 03:45:15,880 --> 03:45:17,400 FDA WHO HAS BECOME REALLY QUITE 5190 03:45:17,400 --> 03:45:19,720 ENGAGED AND FLEXIBLE, AND TRYING 5191 03:45:19,720 --> 03:45:21,040 TO PROMOTE AND ADDRESS YOU WILL 5192 03:45:21,040 --> 03:45:24,880 A THE CHECKS, AND TECHNOLOGY, 5193 03:45:24,880 --> 03:45:31,720 WHICH HAPPENS SO QUICKLY THAT 5194 03:45:31,720 --> 03:45:32,280 IT'S HARD AND REGULATORY 5195 03:45:32,280 --> 03:45:32,920 ENVIRONMENT TO KEEP UP WITH THEM 5196 03:45:32,920 --> 03:45:34,800 ALL. NOW WE HAVE THIS BUT THEN 5197 03:45:34,800 --> 03:45:35,400 NONE OF US KNOW WHAT TO DO IN 5198 03:45:35,400 --> 03:45:39,160 THE PATIENT FINISHES. 5199 03:45:39,160 --> 03:45:45,400 IF THE STUDY ISN'T SUCCESSFUL, 5200 03:45:45,400 --> 03:45:46,000 IF THE DEVICE DOESN'T RECEIVE 5201 03:45:46,000 --> 03:45:46,600 APPROVAL AND CMS DECIDES THAT 5202 03:45:46,600 --> 03:45:47,200 THE EVIDENCE IS NOT WHAT THEY 5203 03:45:47,200 --> 03:45:48,560 WANT OR THE PRIVATE INSURER SO 5204 03:45:48,560 --> 03:45:50,440 THIS IS WHERE WE HAVE THE ISSUE 5205 03:45:50,440 --> 03:45:51,080 AND RHONDA WE NEED AN INSURANCE 5206 03:45:51,080 --> 03:45:53,840 POLICY, WE NEED AN INSURANCE 5207 03:45:53,840 --> 03:45:55,840 POLICY THAT EVERYBODY PAYS INTO. 5208 03:45:55,840 --> 03:45:57,520 BECAUSE AGAIN YOU CAN'T ESTIMATE 5209 03:45:57,520 --> 03:45:59,560 THE RISK. 5210 03:45:59,560 --> 03:46:09,920 PROBABLY EVERY R -- THE RISKS AE 5211 03:46:09,920 --> 03:46:11,360 VERY LOW. 5212 03:46:11,360 --> 03:46:12,520 AND SO THESE ARE MY OPINIONS. 5213 03:46:12,520 --> 03:46:15,160 >> LET ME FOLLOW-UP ON THAT. 5214 03:46:15,160 --> 03:46:18,680 AND THEN SHIRLEY COME TO YOU IN 5215 03:46:18,680 --> 03:46:19,640 A SECOND. 5216 03:46:19,640 --> 03:46:21,600 AND SO LOOK AT THE QUESTION FROM 5217 03:46:21,600 --> 03:46:26,160 THE Q&A, AND ALSO RHONDA FOR 5218 03:46:26,160 --> 03:46:28,200 YOU, AND PERSPECTIVE OF PAYER 5219 03:46:28,200 --> 03:46:31,240 AND SYSTEM IS PAYING. 5220 03:46:31,240 --> 03:46:33,960 HOW QUALITY OF LIFE, 5221 03:46:33,960 --> 03:46:35,920 INCORPORATED INTO THESE 5222 03:46:35,920 --> 03:46:39,320 DECISIONS AS TERM OF CAN 5223 03:46:39,320 --> 03:46:39,720 COVERAGE. 5224 03:46:39,720 --> 03:46:40,920 CAN YOU ANSWER THAT QUESTION 5225 03:46:40,920 --> 03:46:43,360 ALONG WITH MARTY'S? 5226 03:46:43,360 --> 03:46:44,320 >> YES. 5227 03:46:44,320 --> 03:46:45,640 VERY GOOD QUESTION. 5228 03:46:45,640 --> 03:46:47,680 SO QUALITY OF LIFE IS ONE OF THE 5229 03:46:47,680 --> 03:46:49,720 FACTORS THAT ONE LOOKS AT WHEN 5230 03:46:49,720 --> 03:46:52,360 THEY ARE JUDGING THE TECHNOLOGY 5231 03:46:52,360 --> 03:46:53,400 IN ITSELF. 5232 03:46:53,400 --> 03:46:55,680 IT KIND OF GOES BACK TO LOOKING 5233 03:46:55,680 --> 03:46:58,720 AT THE CONDITION ITSELF. 5234 03:46:58,720 --> 03:47:01,920 AND WHAT IT DOES TO THE QUALITY 5235 03:47:01,920 --> 03:47:03,720 OF THAT INDIVIDUAL'S LIFE, AND 5236 03:47:03,720 --> 03:47:06,000 THE LIKELIHOOD OF DISABILITY, 5237 03:47:06,000 --> 03:47:07,280 LIFELONG DISABILITY. 5238 03:47:07,280 --> 03:47:08,840 THE PROBLEM WITH THAT, IS MANY 5239 03:47:08,840 --> 03:47:12,280 OF THE INSURERS DON'T 5240 03:47:12,280 --> 03:47:15,480 NECESSARILY HAVE A DESIGNATED 5241 03:47:15,480 --> 03:47:17,280 POLICY, BECAUSE DISABILITY IS A 5242 03:47:17,280 --> 03:47:23,760 VERY BROAD SUBJECT. 5243 03:47:23,760 --> 03:47:26,600 AND IT'S VERY HARD TO PUT 5244 03:47:26,600 --> 03:47:29,760 QUALIFIERS HOW DISABLED SOMEONE 5245 03:47:29,760 --> 03:47:31,560 NEEDS TO BE. 5246 03:47:31,560 --> 03:47:32,960 AND WHEN ARE THEY CONSIDERED 5247 03:47:32,960 --> 03:47:34,320 DISABLED AND WHAT ARE THE 5248 03:47:34,320 --> 03:47:37,680 DEFINIT 5249 03:47:37,680 --> 03:47:39,320 DEFINITIONS, AND IN ORDER TO 5250 03:47:39,320 --> 03:47:42,640 CREATE A SUBSET OF CONDITIONS 5251 03:47:42,640 --> 03:47:45,360 AND LEVELS OF DISABILITY, SO 5252 03:47:45,360 --> 03:47:49,640 THAT ONE CAN BECLEAR 5253 03:47:49,640 --> 03:48:00,400 OUTLINELINE, WHEN SMIOMETHING I 5254 03:48:07,520 --> 03:48:08,040 COVERED BY A DISABILITY AS 5255 03:48:08,040 --> 03:48:08,640 OPPOSED TO SOMETHING THAT WAS 5256 03:48:08,640 --> 03:48:10,120 VERY CLEAR IF SOMEONE'S GOING TO 5257 03:48:10,120 --> 03:48:10,680 DIE IN A YEAR, OKAY? IT'S A 5258 03:48:10,680 --> 03:48:11,720 LITTLE EASIER TO MAKE THAT 5259 03:48:11,720 --> 03:48:14,480 DISTINCTION. DISABILITY IS VERY 5260 03:48:14,480 --> 03:48:15,080 WIDE, WIDELY DEFINED AND THERE'S 5261 03:48:15,080 --> 03:48:15,800 SO MANY DIFFERENT LEVELS. SO I 5262 03:48:15,800 --> 03:48:16,360 THINK THAT MIGHT BE WHY YOU 5263 03:48:16,360 --> 03:48:17,000 DON'T SEE POLICIES SO TO SPEAK, 5264 03:48:17,000 --> 03:48:19,720 IN WRITING THAT DEAL WITH 5265 03:48:19,720 --> 03:48:20,360 DISABILITY OR QUALITY OF LIFE AS 5266 03:48:20,360 --> 03:48:20,920 A DETERMINANT IN DECISION 5267 03:48:20,920 --> 03:48:21,520 MAKING, IT IS CONSIDERED NOT 5268 03:48:21,520 --> 03:48:26,440 NECESSARILY A DRIVER UNLESS ABLE 5269 03:48:26,440 --> 03:48:29,200 TO DEFINE DISABILITY AND ABLE 5270 03:48:29,200 --> 03:48:31,720 TO PUT IN SOME TYPE OF 5271 03:48:31,720 --> 03:48:33,160 DEFINITION, AND SOME TYPE OF 5272 03:48:33,160 --> 03:48:35,480 REGULATION THAT WOULD ALLOW THAT 5273 03:48:35,480 --> 03:48:36,160 INVESTIGATION AND CONSIDERATION 5274 03:48:36,160 --> 03:48:38,400 IN TERMS OF COVERAGE. 5275 03:48:38,400 --> 03:48:40,880 >> THANKS. 5276 03:48:40,880 --> 03:48:41,160 SHIRLEY. 5277 03:48:41,160 --> 03:48:43,160 >> LET ME LOWER MY HAND NOW. 5278 03:48:43,160 --> 03:48:45,000 HAVE A COUPLE OF THOUGHTS. 5279 03:48:45,000 --> 03:48:48,880 AS A RESEARCH ADMINISTRATOR IT 5280 03:48:48,880 --> 03:48:52,560 IS MY MORAL OBLIGATION, TOLESSEN 5281 03:48:52,560 --> 03:48:53,880 ADMINISTRATION AS MUCH AS 5282 03:48:53,880 --> 03:48:54,800 POSSIBLE. 5283 03:48:54,800 --> 03:48:57,840 BECAUSE IT JUST SEEMS LIKE A -- 5284 03:48:57,840 --> 03:48:59,320 THAT GETS IN THE WAY OF ANYTHING 5285 03:48:59,320 --> 03:48:59,640 HAPPENING. 5286 03:48:59,640 --> 03:49:01,920 I HAVE A COUPLE OF THOUGHTS 5287 03:49:01,920 --> 03:49:05,240 ABOUT STANDARD OF CARE, STANDARD 5288 03:49:05,240 --> 03:49:07,720 OF CARE DOESN'T EVEN WORK, WE 5289 03:49:07,720 --> 03:49:09,240 GET DENIALS ALL THE TIME, AND 5290 03:49:09,240 --> 03:49:13,240 SEEMS LIKE THE GO-TO MOVE IS 5291 03:49:13,240 --> 03:49:15,720 JUST TO DENY. 5292 03:49:15,720 --> 03:49:19,240 I HAVE A COUPLE EXAMPLES. 5293 03:49:19,240 --> 03:49:22,680 PATIENT HAS BRAIN SURGERY, SKULL 5294 03:49:22,680 --> 03:49:27,720 CAP COMES OFF, AND DENIAL TO PUT 5295 03:49:27,720 --> 03:49:30,200 IT BACK, IS DENIED BECAUSE IT'S 5296 03:49:30,200 --> 03:49:32,480 CONSIDERED CONSTANT METTIC, AND 5297 03:49:32,480 --> 03:49:37,720 SO THE PATIENT IS SUPPOSED TO 5298 03:49:37,720 --> 03:49:40,240 WANDER AROUND WITH THE BRAIN 5299 03:49:40,240 --> 03:49:43,720 HANGING OUT OF THEIR HEAD. 5300 03:49:43,720 --> 03:49:44,200 THAT'S EXTREME EXAMPLE. 5301 03:49:44,200 --> 03:49:47,840 BUT WE GET THOSE DENIALS AND 5302 03:49:47,840 --> 03:49:48,400 STANDARDS OF CARE WITH DEEP 5303 03:49:48,400 --> 03:49:48,960 BRAIN STIMULATION, WE STILL 5304 03:49:48,960 --> 03:49:49,600 ROUTINELY GET DENIALS FOR DEEP 5305 03:49:49,600 --> 03:49:50,600 BRAIN STIMULATION TO TREAT 5306 03:49:50,600 --> 03:49:51,120 DYSTONIA, BECAUSE IT WAS 5307 03:49:51,120 --> 03:49:54,320 APPROVED IN 2003 AS A 5308 03:49:54,320 --> 03:49:55,720 HUMANITARIAN DEVICE THAT WAS 20 5309 03:49:55,720 --> 03:49:58,520 YEARS AGO. SO I GUESS MY 5310 03:49:58,520 --> 03:50:01,320 QUESTION IS: DO YOU WANT TO FIX 5311 03:50:01,320 --> 03:50:02,480 THE STANDARD OF CARE SYSTEM? 5312 03:50:02,480 --> 03:50:05,800 OR DO YOU WANT TO TAKE WHAT 5313 03:50:05,800 --> 03:50:08,040 HAPPENS IN CLINICAL TRIAL 5314 03:50:08,040 --> 03:50:10,720 RESEARCH, AND BE INNOVATIVE. 5315 03:50:10,720 --> 03:50:16,480 AND AS MARTHA SAID PUSH THAT TO 5316 03:50:16,480 --> 03:50:18,600 PUSH STANDARD OF CARE TO ADAPT 5317 03:50:18,600 --> 03:50:21,040 AND BECOME BETTER ALSO. 5318 03:50:21,040 --> 03:50:23,840 AND SOMEONE WHO GREW UP IN 5319 03:50:23,840 --> 03:50:32,800 SOCIALIZED COUNTRY, I STRUGGLE 5320 03:50:32,800 --> 03:50:33,360 WITH THAT YOUR HEALTH CARE 5321 03:50:33,360 --> 03:50:33,960 BENEFITS ARE TIED TO ACTUALLY 5322 03:50:33,960 --> 03:50:38,480 HAVING A JOB THAT PROVIDES YOU 5323 03:50:38,480 --> 03:50:39,120 THAT BENEFIT, WHICH I DON'T SEE 5324 03:50:39,120 --> 03:50:39,720 AS A BENEFIT, BUT OTHER THAN 5325 03:50:39,720 --> 03:50:40,320 THAT. AND ANOTHER THING ABOUT 5326 03:50:40,320 --> 03:50:40,960 THE FDA, I HAVE NOTICED CHANGES, 5327 03:50:40,960 --> 03:50:43,480 WHICH I THINK ARE GOOD. HOWEVER 5328 03:50:43,480 --> 03:50:47,720 MY STUDY COORDINATOR CAME AND 5329 03:50:47,720 --> 03:50:48,360 SAID, YOU HAVE A CD LIKE WHAT DO 5330 03:50:48,360 --> 03:50:58,120 YOU NEED TO HAVE A CD FOR. THE 5331 03:50:58,120 --> 03:50:58,680 FDA WANTS ME TO SEND THESE 5332 03:50:58,680 --> 03:51:01,720 DOCUMENTS ON A CD. I'M LIKE, 5333 03:51:01,720 --> 03:51:02,320 YOU'RE ABSOLUTELY KIDDING ME 5334 03:51:02,320 --> 03:51:02,960 RIGHT. SO WE HAD TO SPEND TIME 5335 03:51:02,960 --> 03:51:07,040 FOR A CD, AND THEN NOT EVEN THEN 5336 03:51:07,040 --> 03:51:07,720 WE HAD TO FIND A COMPUTER THAT 5337 03:51:07,720 --> 03:51:08,320 HAD A CD DRIVE, AND THEN A CASE 5338 03:51:08,320 --> 03:51:11,920 TO PUT IT IN. SO, WE ARE MAKING 5339 03:51:11,920 --> 03:51:12,520 PROGRESS BUT WHEN IT COMES TO 5340 03:51:12,520 --> 03:51:13,120 THE ADMINISTRATION, WHICH IS 5341 03:51:13,120 --> 03:51:19,360 WHAT I WANT TO FIX. THOSE ARE 5342 03:51:19,360 --> 03:51:19,960 JUST COMMENTS FOR YOU TO TAKE 5343 03:51:19,960 --> 03:51:22,240 AWAY WITH YOU TODAY. . 5344 03:51:22,240 --> 03:51:23,320 >> THANK YOU FOR TRYING TO 5345 03:51:23,320 --> 03:51:26,920 REDUCE THE ADMINISTRATIVE BURDEN 5346 03:51:26,920 --> 03:51:28,040 FOR OUR CUSTOMERS. 5347 03:51:28,040 --> 03:51:31,360 YOU HAD YOUR HAND UP EARLIER. 5348 03:51:31,360 --> 03:51:33,240 >> IF YOU FOR MAKING US 5349 03:51:33,240 --> 03:51:34,920 PARTNERS IN THERE, FROM EVERY 5350 03:51:34,920 --> 03:51:37,200 STANDPOINT, AND I HAD A QUESTION 5351 03:51:37,200 --> 03:51:41,280 FOR DR. LI, IN THE SENSE THAT, 5352 03:51:41,280 --> 03:51:46,680 YOU KNOW, AS CLINICIAN MYSELF 5353 03:51:46,680 --> 03:51:49,400 AND RESEARCHER, AND FIND THE CD 5354 03:51:49,400 --> 03:51:58,720 MECHANISM FOR VAGUS NERVE 5355 03:51:58,720 --> 03:52:00,080 STIMULATION IS REALLY TANGIBLE 5356 03:52:00,080 --> 03:52:02,520 OPTION FOR PATIENTS WHO 5357 03:52:02,520 --> 03:52:05,120 OTHERWISE, NOT ABLE TO BE ABLE 5358 03:52:05,120 --> 03:52:08,080 TO ENCONTROL IN NIH SPONSORED 5359 03:52:08,080 --> 03:52:11,560 TRIALS AND FOUR WEEKS OFF LABEL 5360 03:52:11,560 --> 03:52:18,840 PROCEDURES, AND THE VAGUS NERVE 5361 03:52:18,840 --> 03:52:21,960 STIMULATION APPROVAL BY FDA IN 5362 03:52:21,960 --> 03:52:22,320 2005. 5363 03:52:22,320 --> 03:52:25,400 LED TO A PERIOD OF, YOU KNOW, 5364 03:52:25,400 --> 03:52:29,000 15, 20 YEARS OF DROUGHT UNTIL 5365 03:52:29,000 --> 03:52:30,880 THIS NEW MECHANISM. 5366 03:52:30,880 --> 03:52:37,040 IS THIS, YOU KNOW, CD WITHOUT AN 5367 03:52:37,040 --> 03:52:39,800 FD APPLICATION BEFORE, 5368 03:52:39,800 --> 03:52:41,680 FORESEEABLE FOR TRIALS THAT 5369 03:52:41,680 --> 03:52:46,960 INVOLVE, FOR EXAMPLE DEEP BRAIN 5370 03:52:46,960 --> 03:52:47,600 STIMULATION FOR NEW INDICATIONS, 5371 03:52:47,600 --> 03:52:48,120 WHETHER IT'S, YOU KNOW, 5372 03:52:48,120 --> 03:52:50,120 DEPRESSION OR OTHER PSYCHIATRIC 5373 03:52:50,120 --> 03:52:54,320 INDICATI 5374 03:52:54,320 --> 03:52:55,400 INDICATIONS.. 5375 03:52:55,400 --> 03:52:57,440 >> , YOU KNOW, AGAIN, EACH 5376 03:52:57,440 --> 03:52:58,880 SITUATION IT'S NUANCED. 5377 03:52:58,880 --> 03:53:02,200 BUT I WOULD SAY IN GENERAL, OUR 5378 03:53:02,200 --> 03:53:03,400 MECHANISMS, LIKE THE OTHER 5379 03:53:03,400 --> 03:53:11,360 PATHWAY IS THE IDE PROCESS, THAT 5380 03:53:11,360 --> 03:53:13,960 REQUIRES THAT INVOLVEMENT, 5381 03:53:13,960 --> 03:53:17,000 THAT'S ONE OF OUR MAJOR PATHWAYS 5382 03:53:17,000 --> 03:53:19,400 WITH THE CMS COVERAGE. 5383 03:53:19,400 --> 03:53:21,400 AND THAT'S THE ID PROCESS, 5384 03:53:21,400 --> 03:53:22,200 INVOLVED IN FDA. 5385 03:53:22,200 --> 03:53:26,120 AND THE CD PROCESS, CVD PROCESS, 5386 03:53:26,120 --> 03:53:28,840 WHEN THE SPONSOR OR MANUFACTURE 5387 03:53:28,840 --> 03:53:31,600 COMES TO US INDIVIDUALLY, AND 5388 03:53:31,600 --> 03:53:34,560 REQUEST NATIONAL COVERAGE. 5389 03:53:34,560 --> 03:53:45,080 I CAN ONLY SPEAK TO SOME OF THE 5390 03:53:45,920 --> 03:53:46,440 NTDS I'VE WORKED ON, ALL WE 5391 03:53:46,440 --> 03:53:47,000 REQUIRE FDA APPROVAL OF THE 5392 03:53:47,000 --> 03:53:50,120 DEVICE FOR THE SERVICE. BEFORE 5393 03:53:50,120 --> 03:53:50,760 WE EVEN CONSIDER LOOKING AT THE, 5394 03:53:50,760 --> 03:53:53,640 AT THAT QUESTION. ON THE OTHER 5395 03:53:53,640 --> 03:53:55,560 HAND, THERE ARE... THERE IS 5396 03:53:55,560 --> 03:53:58,080 ANOTHER PATHWAY, WHERE IF THERE 5397 03:53:58,080 --> 03:54:00,480 ARE QUESTIONS ABOUT FDA APPROVAL 5398 03:54:00,480 --> 03:54:02,560 PROCESS, I MEAN, YOU HAVE 5399 03:54:02,560 --> 03:54:06,280 SOMETHING CALLED LOCAL MEDICARE 5400 03:54:06,280 --> 03:54:08,480 ADMINISTRATIVE CONTRACTS THAT 5401 03:54:08,480 --> 03:54:09,560 LOOK AT LOCAL COVERAGE OF THE 5402 03:54:09,560 --> 03:54:12,400 ITEM OR DEVICE. 5403 03:54:12,400 --> 03:54:14,320 >>KARL: WE SUCCESSFULLY DONE 5404 03:54:14,320 --> 03:54:17,520 THAT FOR OUR PATIENTS WHO 5405 03:54:17,520 --> 03:54:20,120 RECEIVE DEEP BRAIN STIMULATION 5406 03:54:20,120 --> 03:54:24,080 FOR DEPRESSION AT EMORY, AND 5407 03:54:24,080 --> 03:54:27,040 IT'S A UNIQUE ARRANGEMENT WE 5408 03:54:27,040 --> 03:54:29,520 HAVE THAT MEDICARE COVERAGE FOR 5409 03:54:29,520 --> 03:54:32,120 US, AND VERY THANKFUL FOR THAT. 5410 03:54:32,120 --> 03:54:34,120 AND SOMETIMES SEE THE CD 5411 03:54:34,120 --> 03:54:35,400 APPROACH AS WAY OF HAVING 5412 03:54:35,400 --> 03:54:39,360 MEDICARE FUNDED KLEINICAL TRIAL. 5413 03:54:39,360 --> 03:54:42,640 AND, YOU KNOW, BEING TONGUE IN 5414 03:54:42,640 --> 03:54:42,880 CHEEK. 5415 03:54:42,880 --> 03:54:44,800 >> THAT IS THE PURPOSE. 5416 03:54:44,800 --> 03:54:49,120 BUT, TO DEVELOP THE EVIDENCE TO 5417 03:54:49,120 --> 03:54:51,160 PROVIDE NATIONAL COVERAGE 5418 03:54:51,160 --> 03:54:51,520 DETERMINATION. 5419 03:54:51,520 --> 03:54:54,000 SO I MEAN, THAT IS IN FACT THE 5420 03:54:54,000 --> 03:54:57,040 REASON FOR THE CDE PROCESS. 5421 03:54:57,040 --> 03:54:59,400 EVIDENCE IS STILL SOMEWHAT 5422 03:54:59,400 --> 03:55:03,400 EARLY, AND PROMISING, FOR 5423 03:55:03,400 --> 03:55:05,720 EXAMPLE, OBSERVATIONAL STUDIES 5424 03:55:05,720 --> 03:55:07,560 MAY BE TOO SMALL AND NOT THE 5425 03:55:07,560 --> 03:55:11,360 BEST STUDY. 5426 03:55:11,360 --> 03:55:15,920 SO THE EXAMPLE OF PROVIDING 5427 03:55:15,920 --> 03:55:26,440 STANDARDIZED, AND, YOU KNOW, 5428 03:55:32,200 --> 03:55:32,760 THAT EVIDENCE IS SHOWS THAT THE 5429 03:55:32,760 --> 03:55:36,320 BENEFITS OUTWEIGH THE RISKS. THE 5430 03:55:36,320 --> 03:55:36,920 ITEM RELIES ON THE FACT THAT 5431 03:55:36,920 --> 03:55:37,520 THEY WILL PROVIDE A NATIONAL 5432 03:55:37,520 --> 03:55:38,160 COVERAGE, RIGHT, BUT THE ISSUE 5433 03:55:38,160 --> 03:55:39,920 THAT WE HAVE, AS INVESTIGATORS 5434 03:55:39,920 --> 03:55:40,560 MANY TIMES HAS BEEN, YOU KNOW, 5435 03:55:40,560 --> 03:55:41,160 IS THAT THE STANDARDS FOR FDA 5436 03:55:41,160 --> 03:55:41,760 APPROVAL, GO BEYOND, YOU KNOW 5437 03:55:41,760 --> 03:55:43,400 THE DOCUMENTATION OF 5438 03:55:43,400 --> 03:55:43,960 SIGNIFICANT LONG TERM DATA 5439 03:55:43,960 --> 03:55:47,400 SHOWING EFFICACY, LIKE THE 5440 03:55:47,400 --> 03:55:48,000 INITIAL FDA APPROVAL FOR VAGUS 5441 03:55:48,000 --> 03:55:52,400 NERVE STIMULATION IN 2005 AT 5442 03:55:52,400 --> 03:55:53,000 CLINICAL TRIAL THEY HAVE NOT 5443 03:55:53,000 --> 03:55:53,640 BEEN THAT STRONG, BUT THAT THE 5444 03:55:53,640 --> 03:55:57,200 FDA APPROVAL, THEN THEY STOPPED 5445 03:55:57,200 --> 03:56:02,720 COVERING FOR IT IN CMS, AND TOOK 5446 03:56:02,720 --> 03:56:10,120 COMBINED PAPER OF 800 PATIENTS, 5447 03:56:10,120 --> 03:56:10,720 YOU KNOW, DETERMINING LONG TERM 5448 03:56:10,720 --> 03:56:11,360 DATA, SOMETHING THAT WOULD GO, 5449 03:56:11,360 --> 03:56:12,000 CERTAINLY OUTSIDE THE COVERAGE 5450 03:56:12,000 --> 03:56:19,360 OF ANY CLINICAL TRIAL THIS FIVE 5451 03:56:19,360 --> 03:56:21,720 YEARS, 795 PATIENTS BE 5452 03:56:21,720 --> 03:56:23,400 FINANCIALLY VIABLE, AS YOU KNOW, 5453 03:56:23,400 --> 03:56:26,120 I ASSUME, BY A SINGLE COMPANY TO 5454 03:56:26,120 --> 03:56:30,200 FUND AND SUPPORT. SO ALL THE 5455 03:56:30,200 --> 03:56:31,600 STAKEHOLDERS HERE COULD SEE A 5456 03:56:31,600 --> 03:56:35,000 LONG TERM PLAN FOR PATIENTS, 5457 03:56:35,000 --> 03:56:38,120 ESPECIALLY WHEN -- THE LAST 5458 03:56:38,120 --> 03:56:40,200 THING I WANT TO SAY. 5459 03:56:40,200 --> 03:56:45,160 THE REASON WHY WE ARE SO 5460 03:56:45,160 --> 03:56:48,520 INVESTED IN POSTCLINICAL TRIAL 5461 03:56:48,520 --> 03:56:51,480 CARE, IS THAT IN MANY CASES, 5462 03:56:51,480 --> 03:56:53,080 I'VE BEEN PRIVILEGED TO TREAT 5463 03:56:53,080 --> 03:56:54,440 TWO OF MY PATIENTS THAT ARE HERE 5464 03:56:54,440 --> 03:56:57,440 IN THE PANEL TODAY. 5465 03:56:57,440 --> 03:57:00,120 THE BENEFITS, ESPECIALLY IN THE 5466 03:57:00,120 --> 03:57:01,920 CHRONIC CONDITIONS, MANIFEST 5467 03:57:01,920 --> 03:57:04,720 LONG AFTER THE ARBITRARY END 5468 03:57:04,720 --> 03:57:09,120 POINT OF A PRIMARY CLINICAL TIME 5469 03:57:09,120 --> 03:57:13,640 POINT, 6 MONTHS OR 12 MONTHS, 5470 03:57:13,640 --> 03:57:17,560 ESPECIALLY TALKING ABOUT 5471 03:57:17,560 --> 03:57:17,960 FUNCTIONALITY. 5472 03:57:17,960 --> 03:57:19,400 RECOVERY. 5473 03:57:19,400 --> 03:57:20,680 THESE TRIALS TAKE YEARS. 5474 03:57:20,680 --> 03:57:22,160 THAT'S WHY IT WAS SO IMPORTANT 5475 03:57:22,160 --> 03:57:25,760 ON THAT VAGUS NERVE STIMULATION 5476 03:57:25,760 --> 03:57:27,880 STUDY, TO DEMONSTRATE CUMULATIVE 5477 03:57:27,880 --> 03:57:31,400 EVIDENCE OVER 5 YEARS, SOMETHING 5478 03:57:31,400 --> 03:57:34,280 NOT FEASIBLE IN STANDARD 5479 03:57:34,280 --> 03:57:37,240 CLINICAL TRIAL DERIVED FROM DRUG 5480 03:57:37,240 --> 03:57:38,520 TRIALS, 12 WEEKS. 5481 03:57:38,520 --> 03:57:40,200 YOU KNOW, YOU WILL NEVER 5482 03:57:40,200 --> 03:57:41,000 DEMONSTRATE THAT. 5483 03:57:41,000 --> 03:57:47,600 SORRY, THAT WAS MY COMMENT. 5484 03:57:47,600 --> 03:57:49,120 >> I'LL TRY AND ANSWER THE 5485 03:57:49,120 --> 03:57:51,760 QUESTION, AND I'LL START OFF BY 5486 03:57:51,760 --> 03:57:54,000 SAYING THAT, YOU KNOW, THE 5487 03:57:54,000 --> 03:57:56,600 PURPOSE -- OR WHAT FDA LOOKS AT 5488 03:57:56,600 --> 03:58:01,400 AND CMS LOOK AT ARE ACTUALLY 5489 03:58:01,400 --> 03:58:01,840 COMPLEMENTARY. 5490 03:58:01,840 --> 03:58:06,680 AND FDA LOOKS LIKE, LOOKS AT THE 5491 03:58:06,680 --> 03:58:08,840 SAFETY OF THE DEVICE. 5492 03:58:08,840 --> 03:58:11,520 CLINICAL VALIDITY, DOES THE 5493 03:58:11,520 --> 03:58:14,920 DEVICE TEST ACTUALLY TEST WHAT 5494 03:58:14,920 --> 03:58:16,280 IT'S SUPPOSED TO BE TESTING. 5495 03:58:16,280 --> 03:58:20,880 AND LOOK AT CLINICAL UTILITY. 5496 03:58:20,880 --> 03:58:30,680 AND LOOK AT WHETHER OR NOT, ITEM 5497 03:58:30,680 --> 03:58:31,320 HAS LONG TERM IMPROVEMENT, YOU 5498 03:58:31,320 --> 03:58:31,880 KNOW, THE OUTCOME, SUCH AS 5499 03:58:31,880 --> 03:58:34,280 AGAIN, MORE WE USE MORTALITY, 5500 03:58:34,280 --> 03:58:35,400 LIKE GOLD STANDARD, BUT IT CAN 5501 03:58:35,400 --> 03:58:43,400 BE OTHER OTHER OUTCOMES LIKE 5502 03:58:43,400 --> 03:58:44,040 QUALITY OF LIFE, INCLUDE THAT IN 5503 03:58:44,040 --> 03:58:51,400 SOME OF OUR CD STUDIES. AND SO, 5504 03:58:51,400 --> 03:58:56,520 BOTH AGENCIES NEED TO LOOK AT 5505 03:58:56,520 --> 03:58:57,120 AND DETERMINE WHETHER OR NOT, 5506 03:58:57,120 --> 03:59:00,720 YOU KNOW, ITEM MEETS THE 5507 03:59:00,720 --> 03:59:01,240 OBJECTIVES OF INDIVIDUAL 5508 03:59:01,240 --> 03:59:01,760 AGENCIES. SO AGAIN, IN 5509 03:59:01,760 --> 03:59:02,360 GENERALITIES AND THERE'S SOMEONE 5510 03:59:02,360 --> 03:59:06,040 IN THE FDA IN THIS WORKSHOP, BUT 5511 03:59:06,040 --> 03:59:09,920 LOOK AT SAFETY IN PARTICULAR. 5512 03:59:09,920 --> 03:59:15,080 CLINICAL VALIDITY, WE LOOK AT 5513 03:59:15,080 --> 03:59:15,720 CLINICAL UTILITY AND SO THAT'S 5514 03:59:15,720 --> 03:59:20,120 WHY ... . 5515 03:59:20,120 --> 03:59:24,040 >> I'M TRULY SORRY TO INTERRUPT 5516 03:59:24,040 --> 03:59:27,720 YOU, BUT DO YOU INCLUDE PATIENTS 5517 03:59:27,720 --> 03:59:29,320 -- 5518 03:59:29,320 --> 03:59:32,120 >> THE NCD IS ARE BASED ON 5519 03:59:32,120 --> 03:59:32,640 PUBLISHED EVIDENCE. 5520 03:59:32,640 --> 03:59:35,400 >> THAT'S NOT WHAT I'M ASKING. 5521 03:59:35,400 --> 03:59:38,920 I'M ASKING IF YOU HAVE A PATIENT 5522 03:59:38,920 --> 03:59:40,360 ADVOCACY GROUP, BECAUSE THE 5523 03:59:40,360 --> 03:59:42,720 PATIENT S CORE AND CENTRAL TO 5524 03:59:42,720 --> 03:59:43,960 THE QUESTION, AND CORE OF WHAT'S 5525 03:59:43,960 --> 03:59:44,560 GOING ON. 5526 03:59:44,560 --> 03:59:47,400 THE ONLY WAY TO ADDRESS EQUITY 5527 03:59:47,400 --> 03:59:50,760 AND DIVERSITY IS TO INCLUDE 5528 03:59:50,760 --> 03:59:52,360 PATIENTS IN THE CONVERSATION. 5529 03:59:52,360 --> 03:59:55,080 >> SHORT ANSWER, THEY ARE NOT 5530 03:59:55,080 --> 03:59:57,320 INVOLVED IN OUR NATIONAL 5531 03:59:57,320 --> 04:00:02,880 COVERAGE DETERMINATION PROCESS. 5532 04:00:02,880 --> 04:00:05,560 >> TYLER YOU HAVE BEEN VERY 5533 04:00:05,560 --> 04:00:06,240 PATIENT. 5534 04:00:06,240 --> 04:00:08,440 WOULD LOVE TO HEAR YOUR VOICE, 5535 04:00:08,440 --> 04:00:10,400 HAD A GREAT PLEASURE OF HEARING 5536 04:00:10,400 --> 04:00:14,160 YOU TALK IN ONE OF THE 5537 04:00:14,160 --> 04:00:17,760 NEUROSURGICAL MEETINGS A FEW 5538 04:00:17,760 --> 04:00:18,320 WEEKS AGO IN PHILADELPHIA. 5539 04:00:18,320 --> 04:00:20,440 >> APPRECIATE THAT. 5540 04:00:20,440 --> 04:00:26,000 YEAH, I WAS CHATTING WITH NINA 5541 04:00:26,000 --> 04:00:27,880 IN THE CHAT, AND TRYING TO SOAK 5542 04:00:27,880 --> 04:00:28,800 IT ALL IN. 5543 04:00:28,800 --> 04:00:31,080 I WAS GOING TO ASK A SIMILAR 5544 04:00:31,080 --> 04:00:33,280 QUESTION THAT DR. MCCARTNEY 5545 04:00:33,280 --> 04:00:33,520 ASKED. 5546 04:00:33,520 --> 04:00:35,000 NOT JUST IF PATIENTS ARE 5547 04:00:35,000 --> 04:00:36,320 INVOLVED IN THE PROCESS, BUT HOW 5548 04:00:36,320 --> 04:00:38,120 CAN WE BE? 5549 04:00:38,120 --> 04:00:42,640 I HAVE BEEN LISTENING AND 5550 04:00:42,640 --> 04:00:45,680 HEARING A LOT ABOUT AWARENESS 5551 04:00:45,680 --> 04:00:50,160 AND RAISING FUNDS AND DATA. 5552 04:00:50,160 --> 04:00:53,600 AND IT SEEMS LIKE THE BEST WAY 5553 04:00:53,600 --> 04:00:56,840 TO GET IT IS FROM THE HORSES 5554 04:00:56,840 --> 04:00:57,040 MOUTH. 5555 04:00:57,040 --> 04:01:04,680 I'M IN DR. R P STUDY. 5556 04:01:04,680 --> 04:01:07,000 AND LIKE BRANDY MENTIONED 5557 04:01:07,000 --> 04:01:09,280 EARLIER, I'M CONTINUING TO GIVE 5558 04:01:09,280 --> 04:01:12,000 THEM AS MUCH DATA AS POSSIBLE. 5559 04:01:12,000 --> 04:01:15,880 IF IT HELPS WITH TREATMENT 5560 04:01:15,880 --> 04:01:16,360 RESISTANT DEPRESSION. 5561 04:01:16,360 --> 04:01:18,080 I'M ALL FOR IT. 5562 04:01:18,080 --> 04:01:20,280 AND I WAS HONORED AND GRATEFUL 5563 04:01:20,280 --> 04:01:27,440 TO BE ABLE TO SPEAK IN 5564 04:01:27,440 --> 04:01:28,040 PHILADELPHIA, A FEW WEEKS AGO AT 5565 04:01:28,040 --> 04:01:30,680 THE AMERICAN ASSOCIATION OF 5566 04:01:30,680 --> 04:01:32,440 NEUROLOGICAL SURGEONS AND... I 5567 04:01:32,440 --> 04:01:34,320 GUESS... I DIDN'T REALIZE HOW 5568 04:01:34,320 --> 04:01:36,880 MANY HANDS ARE IN THE PIE HERE 5569 04:01:36,880 --> 04:01:39,400 TRYING TO FIGURE OUT HOW TO DO 5570 04:01:39,400 --> 04:01:41,520 THIS. 5571 04:01:41,520 --> 04:01:43,920 IT'S A LITTLE OVERWHELMING, BUT, 5572 04:01:43,920 --> 04:01:45,520 AGAIN, I GUESS MY QUESTION IS 5573 04:01:45,520 --> 04:01:47,800 FOR -- ANYONE CAN ANSWER IT. 5574 04:01:47,800 --> 04:01:51,360 ONE AT A TIME PLEASE. 5575 04:01:51,360 --> 04:01:58,440 BUT, HOW CAN A PATIENT LIKE ME 5576 04:01:58,440 --> 04:02:00,280 HELP AN AS FAR AS NOT JUST 5577 04:02:00,280 --> 04:02:02,120 GIVING YOU GUYS MY PERSPECTIVE, 5578 04:02:02,120 --> 04:02:04,040 BUT AGAIN RAISING THAT 5579 04:02:04,040 --> 04:02:05,360 AWARENESS, AND BEING ABLE TO 5580 04:02:05,360 --> 04:02:06,520 PROVIDE THAT DATA. 5581 04:02:06,520 --> 04:02:08,280 LIKE, WHAT CAN I DO? 5582 04:02:08,280 --> 04:02:18,360 AS AN INDIVIDUAL TO DO THAT? 5583 04:02:18,360 --> 04:02:19,800 >> THAT'S IS A GREAT QUESTION. 5584 04:02:19,800 --> 04:02:23,440 >> I'D LIKE TO MODIFY MY ANSWER 5585 04:02:23,440 --> 04:02:25,960 AND GIVEN IT A LITTLE MORE 5586 04:02:25,960 --> 04:02:27,400 THOUGHT. 5587 04:02:27,400 --> 04:02:30,920 SO IN MY GROUP IN PARTICULAR WE 5588 04:02:30,920 --> 04:02:31,440 HAVE MEDICARE EVIDENCE 5589 04:02:31,440 --> 04:02:33,840 DEVELOPMENT AND COVERAGE 5590 04:02:33,840 --> 04:02:35,000 ADVISORY COMMITTEE. 5591 04:02:35,000 --> 04:02:38,720 SOMETHING CALLED MEDCAC. 5592 04:02:38,720 --> 04:02:39,880 NOT SURE IF PEOPLE ARE FAMILIAR 5593 04:02:39,880 --> 04:02:41,800 WITH THAT. 5594 04:02:41,800 --> 04:02:44,760 THAT'S WHERE WE ASK FOR EXPERT 5595 04:02:44,760 --> 04:02:47,160 ADVICE ON DEVELOPING TECHNOLOGY 5596 04:02:47,160 --> 04:02:54,120 OR ADVICE. AND SO WE GET 5597 04:02:54,120 --> 04:02:56,160 EXPERTS TOGETHER, AND PATIENT 5598 04:02:56,160 --> 04:02:59,360 ADVOCATES AND MANUFACTURERS AND 5599 04:02:59,360 --> 04:03:03,400 A 5600 04:03:03,400 --> 04:03:11,400 ACACADEMIA IN THE FIELD. 5601 04:03:11,400 --> 04:03:12,040 AND CAN BE ANY PARTICULAR TOPIC 5602 04:03:12,040 --> 04:03:13,240 AND THEN ALSO INCLUDES GROUPS OR 5603 04:03:13,240 --> 04:03:14,120 PATIENTS AS WELL, TO WRITE IN 5604 04:03:14,120 --> 04:03:14,720 PERSON, ACCESS TO THE FUTURE 5605 04:03:14,720 --> 04:03:15,240 DIRECTION OR, YOU KNOW, 5606 04:03:15,240 --> 04:03:15,840 PARTICULAR QUESTION REGARDING 5607 04:03:15,840 --> 04:03:18,080 HOW TO ACCESS AN ITEM OR DEVICE. 5608 04:03:18,080 --> 04:03:21,480 SO THAT WAY WE DO A PATIENT 5609 04:03:21,480 --> 04:03:21,840 INPUT. 5610 04:03:21,840 --> 04:03:24,600 ALONG WITH THE MANUFACTURES. 5611 04:03:24,600 --> 04:03:26,600 AND SO THAT'S USUALLY WHAT'S THE 5612 04:03:26,600 --> 04:03:29,240 STATE OF THE ART OF INNOVATIVE 5613 04:03:29,240 --> 04:03:31,200 TECHNOLOGY, SO THROUGH THAT 5614 04:03:31,200 --> 04:03:33,560 MECHANISM, DO GET INPUT FROM 5615 04:03:33,560 --> 04:03:33,840 PATIENTS. 5616 04:03:33,840 --> 04:03:36,000 >> GO AHEAD, NINA. 5617 04:03:36,000 --> 04:03:37,720 >> I WAS JUST GOING TO MENTION 5618 04:03:37,720 --> 04:03:40,200 THAT ON THE AGENDA. 5619 04:03:40,200 --> 04:03:45,880 THE DISCUSSION IS HERE SUPPOSED 5620 04:03:45,880 --> 04:03:47,280 TO BEGIN TO START TO WRAP UP 5621 04:03:47,280 --> 04:03:47,480 NOW. 5622 04:03:47,480 --> 04:03:54,520 IT'S SO RICH, WE DO HAVE JUST 5623 04:03:54,520 --> 04:03:55,400 A COUPLE OF EXTRA MINUTES OF 5624 04:03:55,400 --> 04:03:56,000 WIGGLE ROOM WITH EVERYBODY'S 5625 04:03:56,000 --> 04:03:56,560 PERMISSION TO CONTINUE THIS 5626 04:03:56,560 --> 04:03:57,120 DISCUSSION FOR A FEW MORE 5627 04:03:57,120 --> 04:03:57,640 MINUTES TO MAKE SURE THAT 5628 04:03:57,640 --> 04:03:58,240 EVERYBODY'S VOICES ARE HEARD. 5629 04:03:58,240 --> 04:04:02,960 AND YES, TRACY, PLEASE. HI I'M 5630 04:04:02,960 --> 04:04:08,360 TRACY SALAZAR, I'M EXECUTIVE 5631 04:04:08,360 --> 04:04:09,000 DIRECTOR OF THE LENNOX GASTAUT 5632 04:04:09,000 --> 04:04:13,000 SYNDROME FOUNDATION LIKE DR. 5633 04:04:13,000 --> 04:04:13,640 MOREAU WAS TALKING ABOUT FOR THE 5634 04:04:13,640 --> 04:04:14,240 RNS STUDY VERY SEVERE SHAPE 5635 04:04:14,240 --> 04:04:23,480 POPULATION SEES YOUR START IN 5636 04:04:23,480 --> 04:04:24,000 CHILDHOOD AND THEY BECOME 5637 04:04:24,000 --> 04:04:28,960 DISABLED ADULTS... I'VE HEARD A 5638 04:04:28,960 --> 04:04:29,600 LOT ABOUT FRAMING VALUE AROUND 5639 04:04:29,600 --> 04:04:30,120 ANY POLICY OR RETURN ON 5640 04:04:30,120 --> 04:04:30,680 INVESTMENT OR MONEY MADE OR 5641 04:04:30,680 --> 04:04:35,320 HELPING PATIENTS, BUT WHAT I NOT 5642 04:04:35,320 --> 04:04:36,960 HEARD IS VALUE FRAMEWORK 5643 04:04:36,960 --> 04:04:38,960 CENTERED AROUND PATIENT 5644 04:04:38,960 --> 04:04:39,360 OUTCOMES. 5645 04:04:39,360 --> 04:04:44,160 ONLY PATIENTS CAN WEIGH IN ON 5646 04:04:44,160 --> 04:04:45,840 HOW ABSOLUTELY SHITTY THE 5647 04:04:45,840 --> 04:04:47,400 DISEASE THAT HE ARE LIVING WITH. 5648 04:04:47,400 --> 04:04:49,640 AND WHETHER VALUE HAS BEEN ADDED 5649 04:04:49,640 --> 04:04:50,840 TO SOMETHING. 5650 04:04:50,840 --> 04:04:52,720 WE DON'T HAVE TO INVENT THIS, 5651 04:04:52,720 --> 04:04:57,480 BECAUSE THE FDA FOR THE LAST 10 5652 04:04:57,480 --> 04:04:58,040 YEARS, HAS BEEN MANDATED BY 5653 04:04:58,040 --> 04:04:58,680 LEGISLATION TO CREATE A PATIENT 5654 04:04:58,680 --> 04:05:00,280 FOCUSED DRUG DEVELOPMENT 5655 04:05:00,280 --> 04:05:00,840 FRAMEWORK, WHICH CAN EASILY 5656 04:05:00,840 --> 04:05:01,440 MOVED OVER TO THINKING ABOUT 5657 04:05:01,440 --> 04:05:11,400 DEVICES, WE AT THE FOUNDATION 5658 04:05:11,400 --> 04:05:12,000 DEVELOPMENT MEETING AND WE'VE 5659 04:05:12,000 --> 04:05:12,560 COMPLETED THE RISK BENEFIT 5660 04:05:12,560 --> 04:05:13,200 RATIO, ABOUT WHAT IT'S LIKE TO 5661 04:05:13,200 --> 04:05:14,160 LIVE WITH THE CONDITION. WE'VE 5662 04:05:14,160 --> 04:05:14,800 TALKED WAS LIKE TO INTERACT WITH 5663 04:05:14,800 --> 04:05:15,440 CURRENTLY AVAILABLE TREATMENTS, 5664 04:05:15,440 --> 04:05:18,400 AND THE FDA SET THE STANDARDS 5665 04:05:18,400 --> 04:05:22,320 FOR SAFETY, EFFICACY AND TOLL 5666 04:05:22,320 --> 04:05:22,560 RABLT. 5667 04:05:22,560 --> 04:05:24,440 RIGHT, THINKING ABOUT 5668 04:05:24,440 --> 04:05:26,480 MEDICATION, AND THEY SHIFTED 5669 04:05:26,480 --> 04:05:28,720 THEIR THINKING, I WAS RECENTLY 5670 04:05:28,720 --> 04:05:31,920 IN A MEETING WITH FDA WITH A LOT 5671 04:05:31,920 --> 04:05:33,880 OF DRUG MAKER AND IS DWAGS 5672 04:05:33,880 --> 04:05:38,120 MAKERS AND THE FDA KEPT SAYING 5673 04:05:38,120 --> 04:05:46,160 TO CLINICIANS AND THE 5674 04:05:46,160 --> 04:05:46,760 RESEARCHERS IN THE ROOM. WHAT IS 5675 04:05:46,760 --> 04:05:49,760 IT THAT PATIENTS WANT AND GO A 5676 04:05:49,760 --> 04:05:50,360 STEP FURTHER. IT'S IT'S MORE 5677 04:05:50,360 --> 04:05:50,840 SOPHISTICATED THAN JUST 5678 04:05:50,840 --> 04:05:55,400 ANECDOTALLY ASKING WHAT TRACY 5679 04:05:55,400 --> 04:05:59,400 WANTS FOR HER DAUGHTER. 5680 04:05:59,400 --> 04:06:01,720 IT'S ACTUALLY THAT PATIENT 5681 04:06:01,720 --> 04:06:02,360 ADVOCACY GROUPS ARE DEVELOPING 5682 04:06:02,360 --> 04:06:02,960 OUTCOME MEASURES AND THE WORK 5683 04:06:02,960 --> 04:06:06,760 THAT WE'VE BEEN DOING IN THIS 5684 04:06:06,760 --> 04:06:07,400 SPACE, YOU KNOW OUR KIDS DON'T 5685 04:06:07,400 --> 04:06:08,040 ACHIEVE MILESTONES THEY BARELY 5686 04:06:08,040 --> 04:06:08,640 ACHIEVED IN STONE, BUT WE SEE 5687 04:06:08,640 --> 04:06:09,280 THEM MAKING PROGRESS, , AND YOU 5688 04:06:09,280 --> 04:06:09,880 CAN'T MEASURE THE PROCESS OF 5689 04:06:09,880 --> 04:06:10,520 MAKING WITH CURRENTLY AVAILABLE 5690 04:06:10,520 --> 04:06:11,400 TOOLS, BECAUSE THE WORK THAT 5691 04:06:11,400 --> 04:06:12,040 WE'VE BEEN DOING WITH OTHERS, WE 5692 04:06:12,040 --> 04:06:17,320 CAN MEASURE THE INSTANT. WE HAVE 5693 04:06:17,320 --> 04:06:17,960 FIGURED THAT OUT SO THE FDA IS 5694 04:06:17,960 --> 04:06:18,520 DOING A FOUR PART SERIES ON 5695 04:06:18,520 --> 04:06:19,160 PATIENT FOCUSED DRUG DEVELOPMENT 5696 04:06:19,160 --> 04:06:26,160 THEY PUBLISHED THE FIRST TWO I 5697 04:06:26,160 --> 04:06:26,720 ENCOURAGE YOU GUYS TO READ. 5698 04:06:26,720 --> 04:06:30,640 THE SECOND AND THIRD, WE'RE 5699 04:06:30,640 --> 04:06:31,240 LOOKING AT THE OUTCOME METRICS. 5700 04:06:31,240 --> 04:06:35,280 SO I FEEL LIKE THREE THINGS I 5701 04:06:35,280 --> 04:06:35,920 THINK THE FIRST THING IS WE NEED 5702 04:06:35,920 --> 04:06:36,560 TO SHIFT OUR VALUE FRAMEWORK. 5703 04:06:36,560 --> 04:06:37,160 SO WHAT MATTERS TO PATIENTS, 5704 04:06:37,160 --> 04:06:37,800 PATIENTS SHOULD BE ON PATIENTS 5705 04:06:37,800 --> 04:06:39,360 ARE VERY SOPHISTICATED, I HAVE A 5706 04:06:39,360 --> 04:06:40,000 PHD IN NEUROSCIENCE, I'VE BEEN 5707 04:06:40,000 --> 04:06:42,480 AN ADVOCATE FOR ALMOST 30 YE 5708 04:06:42,480 --> 04:06:43,080 YEARS,I CAN WEIGH IN ON THIS 5709 04:06:43,080 --> 04:06:43,720 STUFF FOR EVERYONE ON THIS CALL 5710 04:06:43,720 --> 04:06:44,320 HAS BEEN DEALING WITH THIS AT 5711 04:06:44,320 --> 04:06:44,920 THE PATIENT HAS BEEN DEALING 5712 04:06:44,920 --> 04:06:46,720 WITH YOU CAN WEIGH IN ON EVERY 5713 04:06:46,720 --> 04:06:47,280 ASPECT OF DEVELOPMENT, BE 5714 04:06:47,280 --> 04:06:47,920 SPEAKING TO EVERYBODY AT EVERY 5715 04:06:47,920 --> 04:06:54,400 LEVEL SHOULD BE SPEAKING TO CMS 5716 04:06:54,400 --> 04:06:54,960 AND NIH. 5717 04:06:54,960 --> 04:06:55,600 NOTHING ABOUT US WITHOUT US. 5718 04:06:55,600 --> 04:07:00,440 FIRST THING I WISH I THINK WE 5719 04:07:00,440 --> 04:07:01,080 DID HAVE VALUE FRAMEWORK SHIFT 5720 04:07:01,080 --> 04:07:02,160 THE WAY WE'RE THINKING ABOUT 5721 04:07:02,160 --> 04:07:07,400 THIS. THE SECOND THING I WOULD 5722 04:07:07,400 --> 04:07:08,000 SAY IS IT'S ALREADY DONE AND 5723 04:07:08,000 --> 04:07:10,880 EXECUTED WITH THE FDA. 5724 04:07:10,880 --> 04:07:12,360 SO WE HAVE IT INVENTED. 5725 04:07:12,360 --> 04:07:19,400 I THINK WE COULD THINK ABOUT 5726 04:07:19,400 --> 04:07:20,040 THIS, AND I LOOK AT WHAT THEY'VE 5727 04:07:20,040 --> 04:07:20,760 DONE. AND I WOULD SAY IS THAT I 5728 04:07:20,760 --> 04:07:21,360 THINK WE NEED TO FIGURE OUT WHAT 5729 04:07:21,360 --> 04:07:22,000 IMPROVEMENT LOOKS LIKE RIGHT? SO 5730 04:07:22,000 --> 04:07:22,640 IT'S ONE THING TO SAY YOU KNOW 5731 04:07:22,640 --> 04:07:27,360 WE DO CLINICAL TRIALS, IT'S A 5732 04:07:27,360 --> 04:07:27,920 50% REDUCTION IN SEIZURES 5733 04:07:27,920 --> 04:07:30,320 DECADES, OR HUNDREDS WEEK. IF 5734 04:07:30,320 --> 04:07:30,840 YOU DO A 50% REDUCTION IN 5735 04:07:30,840 --> 04:07:33,560 SEIZURES TO GET FDA. DID YOU 5736 04:07:33,560 --> 04:07:34,200 REALLY MEET THE PRIMARY AND TO 5737 04:07:34,200 --> 04:07:34,800 DEVELOP TREATMENTS AND, YES, 5738 04:07:34,800 --> 04:07:35,440 SEIZURES ARE CAN BE VERY DEADLY 5739 04:07:35,440 --> 04:07:38,240 IN OUR POPULATION AND SO 5740 04:07:38,240 --> 04:07:38,880 REDUCING THEM IT'S GOOD BUT YOU 5741 04:07:38,880 --> 04:07:43,400 KNOW WHAT IS THINGS THAT REALLY 5742 04:07:43,400 --> 04:07:44,040 MATTER IN ADDITION TO THAT, SO I 5743 04:07:44,040 --> 04:07:45,560 THINK WE NEED TO SET-- AND WE 5744 04:07:45,560 --> 04:07:46,920 CAN DO THIS. 5745 04:07:46,920 --> 04:07:50,120 BECAUSE EVERY LITTLE INDIVIDUAL 5746 04:07:50,120 --> 04:07:52,400 DISEASE IS HAVING THEIR OWN 5747 04:07:52,400 --> 04:07:55,400 PATIENT FOCUSED DRUG DEVELOPMENT 5748 04:07:55,400 --> 04:07:56,000 PLATFORM FOR DEVELOPING THEIR 5749 04:07:56,000 --> 04:08:02,160 OWN, WHAT VALUE IS. AND THEN 5750 04:08:02,160 --> 04:08:02,760 THAT CAN BE THE COMMON THEME 5751 04:08:02,760 --> 04:08:07,400 RATHER THAN SORT OF SHELF 5752 04:08:07,400 --> 04:08:07,960 PATIENTS INTO A POLICY THAT 5753 04:08:07,960 --> 04:08:08,600 WE'RE GOING TO, BECAUSE ALL OF 5754 04:08:08,600 --> 04:08:09,240 US ARE IN THIS TO HELP PATIENTS 5755 04:08:09,240 --> 04:08:14,120 REALLY WANT TO HELP, WHAT'S 5756 04:08:14,120 --> 04:08:18,520 BROKEN IS THE SYSTEM. AND SO 5757 04:08:18,520 --> 04:08:19,120 INSTEAD OF TRYING TO USE THE 5758 04:08:19,120 --> 04:08:19,720 CURRENTLY AVAILABLE SYSTEM TO 5759 04:08:19,720 --> 04:08:21,400 SORT OF SHOVE IN A SOLUTION. 5760 04:08:21,400 --> 04:08:25,280 MAYBE WE CAN THINK ABOUT A 5761 04:08:25,280 --> 04:08:25,920 LITTLE BIT, JUST AS THE FDA HAS 5762 04:08:25,920 --> 04:08:26,480 BEEN DOING FOR THE PAST 10 5763 04:08:26,480 --> 04:08:27,120 YEARS. AND SO JUST SOME THOUGHTS 5764 04:08:27,120 --> 04:08:37,640 TO CONSIDER. >> THANK YOU TRACY 5765 04:08:39,200 --> 04:08:41,080 FOR SHARING THAT. 5766 04:08:41,080 --> 04:08:43,240 I THINK THAT MIGHT BE REALLY 5767 04:08:43,240 --> 04:08:47,240 ELOQUENT WAY TO CLOSE THIS 5768 04:08:47,240 --> 04:08:51,280 PANEL, AND FIRST DAY OF THE 5769 04:08:51,280 --> 04:08:51,520 WORKSHOP. 5770 04:08:51,520 --> 04:08:52,480 AND I THINK WE'RE ALL TAKING IN 5771 04:08:52,480 --> 04:08:54,720 AND SOAKING IN A LOT OF THE 5772 04:08:54,720 --> 04:08:56,000 PERSPECTIVES THAT HAVE BEEN 5773 04:08:56,000 --> 04:08:56,480 SHARED. 5774 04:08:56,480 --> 04:08:58,560 SO I'M GOING TO CLOSE THIS 5775 04:08:58,560 --> 04:09:01,880 AFTERNOON'S PANEL, AND TURN IT 5776 04:09:01,880 --> 04:09:05,320 OVER TO TO WRAP UP FOR DAY ONE. 5777 04:09:05,320 --> 04:09:07,840 >> ALL RIGHT, THANK YOU, 5778 04:09:07,840 --> 04:09:10,560 MODERATORS AND PANELISTS FOR THE 5779 04:09:10,560 --> 04:09:13,120 GREAT SECOND PANEL. 5780 04:09:13,120 --> 04:09:17,040 IT'S A LOT TO PIECE TOGETHER. 5781 04:09:17,040 --> 04:09:19,800 I THINK JUST TO PROVIDE A VERY 5782 04:09:19,800 --> 04:09:20,960 HIGH LEVEL SUMMERY, I THINK 5783 04:09:20,960 --> 04:09:24,760 DURING THE FIRST PANEL TODAY, WE 5784 04:09:24,760 --> 04:09:27,280 HEARD ABOUT MANY NEEDS THAT 5785 04:09:27,280 --> 04:09:28,760 PARTICIPANTS MAY HAVE AFTER A 5786 04:09:28,760 --> 04:09:31,280 TRIAL ENDS. 5787 04:09:31,280 --> 04:09:33,440 THIS INCLUDES FOR EXAMPLE 5788 04:09:33,440 --> 04:09:35,280 CONTINUED ACCESS TO THE DEVICE 5789 04:09:35,280 --> 04:09:36,480 ALREADY IMPLANTED. 5790 04:09:36,480 --> 04:09:40,800 FOLLOW-UP CARE RELATED TO THE 5791 04:09:40,800 --> 04:09:41,040 DEVICE. 5792 04:09:41,040 --> 04:09:43,920 AND DEVICE SUPPORT LIKE 5793 04:09:43,920 --> 04:09:46,280 MAINTENANCE HARDWARE REPLACEMENT 5794 04:09:46,280 --> 04:09:49,720 AND SOFTWARE UPDATES AND DEVICE 5795 04:09:49,720 --> 04:09:52,760 REPLACEMENT IN CERTAIN CASES, 5796 04:09:52,760 --> 04:09:55,400 THAT MAY NEED EMERGENCY CARE, 5797 04:09:55,400 --> 04:09:57,480 AND SIDE EFFECTS OR 5798 04:09:57,480 --> 04:09:59,080 COMPLICATIONS, AND POTENTIALLY 5799 04:09:59,080 --> 04:10:01,920 NEED FOR CARE COORDINATOR, AND 5800 04:10:01,920 --> 04:10:06,040 HEARD PATIENTS NAVIGATE PATHWAYS 5801 04:10:06,040 --> 04:10:07,760 TO FINDING CARE. AND MIGHT NEED 5802 04:10:07,760 --> 04:10:09,760 FOR PSYCHOLOGICAL SUPPORT, AND 5803 04:10:09,760 --> 04:10:12,400 NEED FOR STRONG, ADEQUATE 5804 04:10:12,400 --> 04:10:13,920 CONSENT, AND HEARD ABOUT 5805 04:10:13,920 --> 04:10:15,080 PATIENTS THROUGH RESEARCH 5806 04:10:15,080 --> 04:10:15,320 DESIGN. 5807 04:10:15,320 --> 04:10:18,880 AND HEARD ABOUT THE NEEDS FOR 5808 04:10:18,880 --> 04:10:22,880 REGISTRIES, WITH DEVELOPMENT 5809 04:10:22,880 --> 04:10:23,840 INFORMATION PROVIDERS COULD HAVE 5810 04:10:23,840 --> 04:10:26,920 ACCESS TO RELEVANT INFORMATION. 5811 04:10:26,920 --> 04:10:30,080 AND APOLOGIZE IF I'M SKIPPING 5812 04:10:30,080 --> 04:10:33,080 SOME NEEDS, BUT WE'LL WILL SURE 5813 04:10:33,080 --> 04:10:35,080 TO REGISTER ALL OF THEM AT A 5814 04:10:35,080 --> 04:10:36,720 LATER POINT IN TIME. 5815 04:10:36,720 --> 04:10:37,320 AND DURING THE SECOND PANEL WE 5816 04:10:37,320 --> 04:10:42,480 HEARD ONCE ALREADY BEING 5817 04:10:42,480 --> 04:10:43,960 COVERED. 5818 04:10:43,960 --> 04:10:47,920 IN PART, THE ANSWER THERE SOUNDS 5819 04:10:47,920 --> 04:10:50,320 LIKE IT DEPENDS. 5820 04:10:50,320 --> 04:10:51,600 THERE ARE A NUMBER OF THINGS 5821 04:10:51,600 --> 04:10:54,280 THAT ARE USUALLY COVERED BY 5822 04:10:54,280 --> 04:10:57,560 INSURANCE, INCLUDING EMERGENCY 5823 04:10:57,560 --> 04:11:02,560 CARE, OR EXPLANTATION IF IT'S 5824 04:11:02,560 --> 04:11:03,840 NEEDED FOR PROGRESSIVE 5825 04:11:03,840 --> 04:11:05,240 COMPLICATION OF THE DEVICE. 5826 04:11:05,240 --> 04:11:07,480 BUT IN MANY OTHER CASES, 5827 04:11:07,480 --> 04:11:10,000 DIFFERENT STAKEHOLDERS MAY OR 5828 04:11:10,000 --> 04:11:12,200 MAY NOT PROVIDE A CERTAIN TYPE 5829 04:11:12,200 --> 04:11:19,760 OF CARE DEPENDING ON THE CASE. 5830 04:11:19,760 --> 04:11:21,080 SOMETIMES IT'S A CASE BY CAY 5831 04:11:21,080 --> 04:11:22,760 BASIS, AND HEARD OF POLICIES 5832 04:11:22,760 --> 04:11:23,640 WHERE IT MAY FIT INSIDE OR 5833 04:11:23,640 --> 04:11:27,160 OUTSIDE OF THE POLICY. 5834 04:11:27,160 --> 04:11:30,040 I THINK FOR MANY OF THE TRIALS 5835 04:11:30,040 --> 04:11:31,920 NEEDS, WE HAVEN'T HEARD THAT 5836 04:11:31,920 --> 04:11:34,680 THERE IS CONSISTENT PROVISION OF 5837 04:11:34,680 --> 04:11:35,920 THIS CARE. 5838 04:11:35,920 --> 04:11:40,480 SO, I THINK THAT'S SOMEWHERE WE 5839 04:11:40,480 --> 04:11:42,440 WILL PICK UP TOMORROW, AS WE 5840 04:11:42,440 --> 04:11:44,440 START TO THINK ABOUT WHAT CARE 5841 04:11:44,440 --> 04:11:46,000 NEEDS SHOULD BE COVERED. 5842 04:11:46,000 --> 04:11:48,320 WHICH, I GUESS IS MY BRIDGE TO 5843 04:11:48,320 --> 04:11:49,560 TALKING ABOUT TOMORROW, WHERE WE 5844 04:11:49,560 --> 04:11:52,280 HOPE THAT ALL OF YOU WILL JOIN 5845 04:11:52,280 --> 04:11:53,680 US THEN. 5846 04:11:53,680 --> 04:11:55,240 WE'RE GOING TO HAVE ANOTHER TWO 5847 04:11:55,240 --> 04:11:56,680 SESSIONS IN THE AFTERNOON. 5848 04:11:56,680 --> 04:11:59,560 AND THE FIRST OF WHICH, IS GOING 5849 04:11:59,560 --> 04:12:04,080 TO COVER WHAT POST-TRIAL NEEDS 5850 04:12:04,080 --> 04:12:04,880 TO BE COVERED. 5851 04:12:04,880 --> 04:12:06,200 AND SECOND PANEL IS GOING TO 5852 04:12:06,200 --> 04:12:09,480 LOOK AT, OKAY, GIVEN THE 5853 04:12:09,480 --> 04:12:11,160 THINGS... GIVEN THE THINGS THAT 5854 04:12:11,160 --> 04:12:13,680 SHOULD BE COVERED -- SORRY ABOUT 5855 04:12:13,680 --> 04:12:16,920 THAT -- WHAT ARE THE GAPS IN 5856 04:12:16,920 --> 04:12:18,640 TERMS OF WHAT WE HEARD IN WHAT 5857 04:12:18,640 --> 04:12:19,920 IS CURRENTLY COVERED AND HOW CAN 5858 04:12:19,920 --> 04:12:22,160 WE BEST FILL THE GAPS, AND 5859 04:12:22,160 --> 04:12:23,960 HOPING THAT IS WHERE SOME OF THE 5860 04:12:23,960 --> 04:12:25,600 SOLUTIONS HAVE ALREADY BEEN 5861 04:12:25,600 --> 04:12:27,600 PROPOSED, AND MIGHT COME BACK 5862 04:12:27,600 --> 04:12:29,640 AND START TALKING ABOUT HOW WE 5863 04:12:29,640 --> 04:12:31,920 CAN APPROACH THEM, AND WHAT THE 5864 04:12:31,920 --> 04:12:34,440 NEXT STEPS COULD BE AND SO ON. 5865 04:12:34,440 --> 04:12:39,080 SO WITH THAT, I WANT TO ASK THE 5866 04:12:39,080 --> 04:12:49,600 CO-CHAIRS, AND THE EUROETHICS 5867 04:12:53,120 --> 04:12:55,160 WORKING GROUP IF THEY HAVE 5868 04:12:55,160 --> 04:12:55,800 SOMETHING ADDITIONAL TO ADD AND 5869 04:12:55,800 --> 04:12:58,120 I WANT TO AGAIN THANK YOU, 5870 04:12:58,120 --> 04:12:58,760 THANK YOU ALL FOR PARTICIPATING. 5871 04:12:58,760 --> 04:12:59,360 THANK YOU ALL FOR ATTENDING AND 5872 04:12:59,360 --> 04:13:02,880 I, I HOPE TO SEE YOU TOO,AND SEE 5873 04:13:02,880 --> 04:13:04,200 IF YOU HAVE SOMETHING TO ADD. 5874 04:13:04,200 --> 04:13:06,680 >> GREAT FIRST DAY, AND LOOKING 5875 04:13:06,680 --> 04:13:07,920 FORWARD TO TOMORROW. 5876 04:13:07,920 --> 04:13:10,600 >> PRETTY MUCH WHAT I WANTED TO 5877 04:13:10,600 --> 04:13:13,280 SAY, WONDERFUL PRESENTATION AND 5878 04:13:13,280 --> 04:13:15,760 DISCUSSION, AND LOTS TO THINK 5879 04:13:15,760 --> 04:13:17,160 ABOUT, AND TALK ABOUT TOMORROW 5880 04:13:17,160 --> 04:13:18,600 AS WELL. 5881 04:13:18,600 --> 04:13:18,960 THANK YOU ALL. 5882 04:13:18,960 --> 04:13:21,560 >> RIGHT WITH THAT WE CAN END 5883 04:13:21,560 --> 04:13:22,320 TODAY'S MEETING AND THANK YOU 5884 04:13:22,320 --> 04:13:23,000 ALL AGAIN, AND LOOKING FORWARD 5885 04:13:23,000 --> 04:13:24,320 TO SEEING YOU TOMORROW AND 5886 04:13:24,320 --> 04:13:25,600 THINKING ABOUT HOW TO RESOLVE 5887 04:13:25,600 --> 00:00:00,000 THESE COMPLICATED ISSUES.