1 00:00:05,739 --> 00:00:10,444 THANK YOU, HELLO, I AM 2 00:00:10,444 --> 00:00:15,115 DR. CANDACE TIN JEN. I WORK 3 00:00:15,115 --> 00:00:16,984 WITH THE HUMAN AND HEALTH 4 00:00:16,984 --> 00:00:18,986 DEVELOPMENT WHICH IS ONE OF THE 5 00:00:18,986 --> 00:00:20,754 MANY INSTITUTES ON BEHALF OF THE 6 00:00:20,754 --> 00:00:26,760 BRANCH I AM VERY EXCITED TO 7 00:00:26,760 --> 00:00:30,898 WELCOME YOU ALL HERE. WE AROUND 8 00:00:30,898 --> 00:00:32,132 700 REGISTRANTS SO CLEARLY AN 9 00:00:32,132 --> 00:00:35,903 ITEM OF INTEREST GYNECOLOGIC 10 00:00:35,903 --> 00:00:39,573 PAIN FOR OUR COMMUNITIES 11 00:00:39,573 --> 00:00:43,777 SOMETHING WE KNOW THAT IS OFTEN 12 00:00:43,777 --> 00:00:45,479 IGNORED OR GASLIT OR SOMETIMES 13 00:00:45,479 --> 00:00:47,247 OVERLOOKED FOR A LOT OF OUR 14 00:00:47,247 --> 00:00:48,582 POPULATIONS IN THE CLINIC, ET 15 00:00:48,582 --> 00:00:50,384 CETERA, SO WE ARE REALLY HAPPY 16 00:00:50,384 --> 00:00:54,922 TO BE HERE ABLE TO BE ABLE TO 17 00:00:54,922 --> 00:00:57,724 PUT A SPOTLIGHT ON THIS AND I 18 00:00:57,724 --> 00:00:58,792 WANT TO BE BRIEF SO WE CAN FOCUS 19 00:00:58,792 --> 00:01:02,863 ON THE FANTASTIC AGENDA SO 20 00:01:02,863 --> 00:01:05,332 DR. HELENA AUN HAS LED THE 21 00:01:05,332 --> 00:01:06,934 CREATION OF THIS AGENDA WITH HER 22 00:01:06,934 --> 00:01:09,803 PLANNING COMMITTEE SO WE THANK 23 00:01:09,803 --> 00:01:10,837 THE COMMITTEE FOR THAT AND I 24 00:01:10,837 --> 00:01:12,673 WANT TO SAY WE HAVE A REALLY 25 00:01:12,673 --> 00:01:13,907 PACKED AGENDA. SO WE ARE GOING 26 00:01:13,907 --> 00:01:20,514 TO TURN IT OVER TO ALL OF YOUR 27 00:01:20,514 --> 00:01:22,316 OUR BRILLIANT SPEAKERS AND WE 28 00:01:22,316 --> 00:01:23,817 WILL HAVE THE QUESTION AND 29 00:01:23,817 --> 00:01:27,220 ANSWER IN THE CHAT AND OUR 30 00:01:27,220 --> 00:01:28,288 MODERATORS WILL BRING THE 31 00:01:28,288 --> 00:01:30,157 QUESTIONS TO THE SPEAKERS. SO 32 00:01:30,157 --> 00:01:32,893 WITH THAT I WANT TO TURN IT OVER 33 00:01:32,893 --> 00:01:38,031 TO OUR NICHD DEPUTY DIRECTOR 34 00:01:38,031 --> 00:01:38,265 ALISON. 35 00:01:38,265 --> 00:01:41,668 >> THANKS, FIRST OFF I WANT TO 36 00:01:41,668 --> 00:01:50,577 ADD MY THANKS. TO SAY I'M SO 37 00:01:50,577 --> 00:01:52,412 EXCITED, WE HAVE AN EXCELLENT 38 00:01:52,412 --> 00:01:54,047 AGENDA TODAY. I PARTICULARLY 39 00:01:54,047 --> 00:01:59,486 WOULD LIKE TO THANK THE GOING 40 00:01:59,486 --> 00:01:59,820 K 41 00:01:59,820 --> 00:02:01,688 GOING KOE LOGIC HEALTH AND 42 00:02:01,688 --> 00:02:03,790 DISEASE BRANCH. 43 00:02:03,790 --> 00:02:05,726 I ALSO WANT TO THANK ALL THE 44 00:02:05,726 --> 00:02:07,160 PRESENTERS WHO ARE WILL BE TO 45 00:02:07,160 --> 00:02:10,097 SHARE AND DISCUSS EMERGING 46 00:02:10,097 --> 00:02:12,299 TRENDS WITHIN GEICO LOGIC PAIN 47 00:02:12,299 --> 00:02:13,767 RESEARCH AND ALSO PARTICULARLY 48 00:02:13,767 --> 00:02:14,935 GLAD THAT WE HAVE OUR COLLEAGUES 49 00:02:14,935 --> 00:02:16,570 FROM THE U.S. FOOD AND DRUG 50 00:02:16,570 --> 00:02:17,237 ADMINISTRATION FOR TAKING THE 51 00:02:17,237 --> 00:02:19,906 TIME TO JOIN US TO DISCUSS FDA 52 00:02:19,906 --> 00:02:23,076 REVIEW OF GYNECOLOGIC DEVICES 53 00:02:23,076 --> 00:02:25,979 AND INVESTIGATIONAL NEW DRUG 54 00:02:25,979 --> 00:02:28,015 PROCESSES AND ALSO THANK YOU TO 55 00:02:28,015 --> 00:02:28,582 REPRESENTATIVES FROM TIGHT 56 00:02:28,582 --> 00:02:32,753 LIPPED WHO ARE HERE TO PROVIDE 57 00:02:32,753 --> 00:02:34,621 THE PATIENT PERSPECTIVE ON 58 00:02:34,621 --> 00:02:36,623 CHRONIC PELVIC PAIN. THESE ARE 59 00:02:36,623 --> 00:02:38,692 CRITICAL TO UNDERSTANDING OUR 60 00:02:38,692 --> 00:02:40,127 ABILITY TO ADDRESS GOING KOE 61 00:02:40,127 --> 00:02:41,828 LOGIC PAIN AND I THINK WE 62 00:02:41,828 --> 00:02:44,865 NORMALIZE THIS SO MUCH. THAT 63 00:02:44,865 --> 00:02:48,201 IT'S REALLY CRITICAL FOR US TO 64 00:02:48,201 --> 00:02:49,302 UNDERSTAND THIS DOES NOT HAVE TO 65 00:02:49,302 --> 00:02:51,605 BE NORMAL AND SOME OF THE 66 00:02:51,605 --> 00:02:52,205 SIGNIFICANT IMPAIRMENTS THAT 67 00:02:52,205 --> 00:02:54,508 PEOPLE DO FACE IN THE FACE OF 68 00:02:54,508 --> 00:02:56,510 CHRONIC GOING KOE LOGIC PAIN SO, 69 00:02:56,510 --> 00:02:58,178 YOU KNOW, WE REALLY ARE EXCITED 70 00:02:58,178 --> 00:03:05,285 ABOUT THIS DISCUSSION TODAY. WE 71 00:03:05,285 --> 00:03:08,789 HOPE WE ARE GOING TO MOVE THE 72 00:03:08,789 --> 00:03:10,891 NEED. IT AFFECTS 26 MILLION 73 00:03:10,891 --> 00:03:12,759 PEOPLE WORLDWIDE AND OFTEN 74 00:03:12,759 --> 00:03:13,760 IGNORED. YOU KNOW, FOR MANY 75 00:03:13,760 --> 00:03:15,495 PEOPLE THE PAIN IS SEVERE ENOUGH 76 00:03:15,495 --> 00:03:17,064 FOR THEM TO MISS WORK OR SCHOOL 77 00:03:17,064 --> 00:03:18,832 AND IT AFFECTS THEIR DAILY 78 00:03:18,832 --> 00:03:20,267 LIVES. PAIN CAN BE 79 00:03:20,267 --> 00:03:21,802 DEBILITATING, IT CAN HAVE 80 00:03:21,802 --> 00:03:24,404 IMPACTS ON MENTAL HEALTH AND 81 00:03:24,404 --> 00:03:25,739 QUALITY OF LIFE. AND REALLY THE 82 00:03:25,739 --> 00:03:27,774 OTHER THING THAT I THINK CANDACE 83 00:03:27,774 --> 00:03:30,210 MENTIONED IS, YOU KNOW, IN -- 84 00:03:30,210 --> 00:03:33,713 OFTENTIMES PEOPLE ARE TOLD WELL 85 00:03:33,713 --> 00:03:36,650 IT'S JUST NORMAL. IT'S WHAT 86 00:03:36,650 --> 00:03:39,553 HAPPENS. THERE'S A STIGMA, A 87 00:03:39,553 --> 00:03:41,121 SOCIETAL NORMALIZATION AND THAT 88 00:03:41,121 --> 00:03:43,223 PRESENTS A MAJOR BARRIER TO CARE 89 00:03:43,223 --> 00:03:44,858 IF PEOPLE UNDERSTAND THAT IS NOT 90 00:03:44,858 --> 00:03:47,894 NORMAL AND NEEDS ATTENTION. AND 91 00:03:47,894 --> 00:03:48,562 DIAGNOSIS OF CONDITIONS THAT 92 00:03:48,562 --> 00:03:51,331 CAUSE GYNECOLOGIC PAIN ARE OFTEN 93 00:03:51,331 --> 00:03:52,466 DELAYED. CAUSE MANY PEOPLE TO 94 00:03:52,466 --> 00:03:54,734 LIVE FOR YEARS WITHOUT 95 00:03:54,734 --> 00:03:58,271 TREATMENT. AND ALSO AFFECTS 96 00:03:58,271 --> 00:04:03,110 RESEARCHERS ABILITY. OUR 97 00:04:03,110 --> 00:04:04,478 MISSION IS TO LEAD RESEARCH AND 98 00:04:04,478 --> 00:04:06,713 TRAINING TO UNDERSTAND HUMAN 99 00:04:06,713 --> 00:04:08,081 DEVELOPMENT, IMPROVE 100 00:04:08,081 --> 00:04:09,416 REPRODUCTIVE HEALTH AND ENHANCE 101 00:04:09,416 --> 00:04:11,751 THE LIVES OF CHILDREN AND 102 00:04:11,751 --> 00:04:12,519 ADOLESCENTS AND OPTIMIZE 103 00:04:12,519 --> 00:04:14,020 ABILITIES FOR ALL. ONE OF OUR 104 00:04:14,020 --> 00:04:16,022 RESEARCH THEMES FOR OUR 105 00:04:16,022 --> 00:04:17,824 STRATEGIC PLAN IS PROMOTING 106 00:04:17,824 --> 00:04:20,560 GYNECOLOGIC ANDRO LODGE AND I 107 00:04:20,560 --> 00:04:21,795 CAN REPRODUCTIVE HEALTH. 108 00:04:21,795 --> 00:04:24,764 AND ONE OF OUR ASPIRATIONAL 109 00:04:24,764 --> 00:04:27,167 GOALS IS REALLY SPECIFICALLY 110 00:04:27,167 --> 00:04:29,035 TARGET AROUND THE DIAGNOSIS, 111 00:04:29,035 --> 00:04:32,973 PREVENTION AND TREATMENT OF ENDO 112 00:04:32,973 --> 00:04:37,878 KNOW TRIO SIS WHICH AFFECTS 10% 113 00:04:37,878 --> 00:04:39,679 OF WOMEN IN THE U.S. JUST 114 00:04:39,679 --> 00:04:41,314 WRAPPED UP IN THE MISSION AND 115 00:04:41,314 --> 00:04:45,385 OUR STRATEGY AND YOUR GOALS WE 116 00:04:45,385 --> 00:04:47,420 REALLY DO HAVE GYNECOLOGIC PAIN 117 00:04:47,420 --> 00:04:49,456 BOTH AS A REPRODUCTIVE HEALTH 118 00:04:49,456 --> 00:04:49,723 CONCERN. 119 00:04:49,723 --> 00:04:50,724 BECAUSE SOME OF THE CONDITIONS 120 00:04:50,724 --> 00:04:52,125 THAT CAUSE IT ARE LINKED TO 121 00:04:52,125 --> 00:04:53,393 OTHER AREAS WHERE WE HAVE 122 00:04:53,393 --> 00:04:55,495 PARTICULAR INTERESTS. BUT IT'S 123 00:04:55,495 --> 00:04:57,063 ALSO REALLY CRITICAL, YOU KNOW, 124 00:04:57,063 --> 00:04:58,665 NOT EVEN FOR REPRODUCTIVE HEALTH 125 00:04:58,665 --> 00:05:02,736 BUT FOR THE DAILY LIVES. OF 126 00:05:02,736 --> 00:05:07,874 PEOPLE WHO HAVE BEEN AFFECTED BY 127 00:05:07,874 --> 00:05:10,076 THIS. BY ADOLESCENTS BY 128 00:05:10,076 --> 00:05:12,279 REPRODUCTIVE AGE PEOPLE WHO ARE 129 00:05:12,279 --> 00:05:15,115 AFFECTED AND EVEN INTO THE OLDER 130 00:05:15,115 --> 00:05:21,321 AGES WE CONDUCT SUPPORTIVE 131 00:05:21,321 --> 00:05:27,260 RESEARCH. WITH GYNECOLOGIC PAIN 132 00:05:27,260 --> 00:05:31,665 AND FIBROIDS AND WE WORK WITH 133 00:05:31,665 --> 00:05:35,802 THE PELVIC FLOOR DIAGNOSIS OF 134 00:05:35,802 --> 00:05:38,138 CARE AND TREATMENT OF WOMEN WITH 135 00:05:38,138 --> 00:05:41,308 PUBLIC FLOOR DISORDERS. WE 136 00:05:41,308 --> 00:05:43,410 RECENTLY WORKED IN CALIFORNIA 137 00:05:43,410 --> 00:05:48,949 THAT FOUND THAT A NONSTEROIDAL 138 00:05:48,949 --> 00:05:50,317 ANTI-INFLAMMATORY DRUG WORKED IN 139 00:05:50,317 --> 00:05:54,754 A RODENT MODEL OF ENDOMETRIOSIS. 140 00:05:54,754 --> 00:05:55,455 THIS COULD BE PRESCRIBED MORE 141 00:05:55,455 --> 00:05:57,490 FREQUENTLY FOR ENDOMETRIOSIS 142 00:05:57,490 --> 00:05:59,259 PAIN. WE ALSO RECENTLY HELD A 143 00:05:59,259 --> 00:06:01,428 PANEL DISCUSSION ABOUT ADVANCES 144 00:06:01,428 --> 00:06:06,099 AND NEW DIRECTIONS IN ENDONE MEE 145 00:06:06,099 --> 00:06:08,835 TRIO SIS. AND ADVOCACY 146 00:06:08,835 --> 00:06:11,004 FOLLOWING A SCREENING OF THE 147 00:06:11,004 --> 00:06:12,772 DOCUMENTARY BELOW THE BELT A 148 00:06:12,772 --> 00:06:14,774 FILM BY DIRECTOR SHANNON KOEN 149 00:06:14,774 --> 00:06:18,278 THAT THEN IS AVAILABLE ON OUR 150 00:06:18,278 --> 00:06:20,180 NICHD WEBSITE WE HAVE RECENTLY 151 00:06:20,180 --> 00:06:21,414 LAUNCHED AND HOPE TO BE REALLY 152 00:06:21,414 --> 00:06:23,183 COMING OUT WITH MORE INFORMATION 153 00:06:23,183 --> 00:06:24,751 ON SOON. 154 00:06:24,751 --> 00:06:26,052 THE ADVANCING CURES AND 155 00:06:26,052 --> 00:06:29,055 THERAPIES AND ENDING 156 00:06:29,055 --> 00:06:29,723 ENDOMETRIOSIS DIAGNOSTIC DELAYS 157 00:06:29,723 --> 00:06:30,957 INITIATIVE WE'RE GOING TO BE 158 00:06:30,957 --> 00:06:33,293 PROVIDING ADDITIONAL INFORMATION 159 00:06:33,293 --> 00:06:34,027 ABOUT THE RESEARCH OPPORTUNITIES 160 00:06:34,027 --> 00:06:34,794 THAT WILL BE AVAILABLE, 161 00:06:34,794 --> 00:06:36,596 HOPEFULLY VERY SOON. SO JUST IN 162 00:06:36,596 --> 00:06:40,066 CLOSING, I WANT TO RESTATE OUR 163 00:06:40,066 --> 00:06:44,738 COMMITMENT. AT NICHD TO 164 00:06:44,738 --> 00:06:46,473 SUPPORTING HEALTH IN GYNECOLOGIC 165 00:06:46,473 --> 00:06:48,174 PAIN RESEARCH. WE HAVE WORKED 166 00:06:48,174 --> 00:06:50,710 WITH RESEARCHERS AND ADVOCATES 167 00:06:50,710 --> 00:06:52,312 AND I THINK WITH YOUR HELP WE 168 00:06:52,312 --> 00:06:56,750 CAN WORK TOGETHER TO BETTER 169 00:06:56,750 --> 00:06:58,551 UNDERSTAND, AND TREAT 170 00:06:58,551 --> 00:06:59,920 GYNECOLOGIC PAIN. I WANT TO 171 00:06:59,920 --> 00:07:02,922 TURN IT TO DR. AUN BOTH WITH MY 172 00:07:02,922 --> 00:07:04,124 THANKS, TO HER AND ALSO I'M 173 00:07:04,124 --> 00:07:06,459 GOING TO TURN IT OVER TO HER TO 174 00:07:06,459 --> 00:07:08,395 PROVIDE AN OVERVIEW OF THE 175 00:07:08,395 --> 00:07:09,562 GYNECOLOGIC HEALTH AND DISEASE 176 00:07:09,562 --> 00:07:11,264 BRANCH AND GYNECOLOGIC PAIN 177 00:07:11,264 --> 00:07:12,098 PROGRAM AND THANK YOU AGAIN TO 178 00:07:12,098 --> 00:07:13,400 ALL THE PRESENTERS I'M REALLY 179 00:07:13,400 --> 00:07:16,002 LOOKING FORWARD TO THIS MEETING 180 00:07:16,002 --> 00:07:18,605 AND HOPE EVERYONE ENJOYS IT. SO 181 00:07:18,605 --> 00:07:23,743 DR. AUN. OVER TO YOU. 182 00:07:23,743 --> 00:07:26,379 >> THANK YOU SO MUCH, DR. 183 00:07:26,379 --> 00:07:28,915 THANK YOU 184 00:07:28,915 --> 00:07:32,252 VERY MUCH FOR JOINING THE 2024 185 00:07:32,252 --> 00:07:35,588 THIRD NICHD PAIN RESEARCH 186 00:07:35,588 --> 00:07:39,426 VIRTUAL MIGHT. I AM A PROGRAM 187 00:07:39,426 --> 00:07:44,731 OFFICER. I HAVE NO DISCLOSURE. 188 00:07:44,731 --> 00:07:47,167 SINCE DR. CERTAIN ITCH MENTIONED 189 00:07:47,167 --> 00:07:50,970 THE MISSION I WILL SKIP THIS. 190 00:07:50,970 --> 00:07:57,010 AND SHE ALSO MANAGED THE 191 00:07:57,010 --> 00:07:59,312 STRATEGIC PLAN. AND THE PLAN OF 192 00:07:59,312 --> 00:08:00,547 2020 HAS FIVE THEMES. THE 193 00:08:00,547 --> 00:08:04,117 SECOND THOOIM THEME IS PROMOTING 194 00:08:04,117 --> 00:08:05,485 GYNECOLOGICAL AND ANDRO LOGICAL 195 00:08:05,485 --> 00:08:07,387 AND REPRODUCTIVE HEALTH. 196 00:08:07,387 --> 00:08:12,926 AND NICHD ALSO HAS ASPIRATIONAL 197 00:08:12,926 --> 00:08:15,128 ROLES AND THE SECOND ONE OF THE 198 00:08:15,128 --> 00:08:17,364 ASPIRATIONAL GOALS IS TO 199 00:08:17,364 --> 00:08:21,468 DIAGNOSIS, PREVENT AND TREAT 200 00:08:21,468 --> 00:08:22,969 ENDOMETRIOSIS WHICH IS ALSO 201 00:08:22,969 --> 00:08:28,241 RELEVANT. AND NICHD DIVIDEND OF 202 00:08:28,241 --> 00:08:30,510 EXMURAL RESEARCH HAS TWELVE 203 00:08:30,510 --> 00:08:31,978 BRANCHES ONE OF THEM IS 204 00:08:31,978 --> 00:08:35,715 GYNECOLOGIC HEALTH AND DISEASE 205 00:08:35,715 --> 00:08:38,952 BRANCH. AND SGSHGSHDB AIM TO 206 00:08:38,952 --> 00:08:40,253 IMPROVE WOMEN'S REPRODUCTIVE 207 00:08:40,253 --> 00:08:42,822 HEALTH BY GUIDING AND SUPPORTING 208 00:08:42,822 --> 00:08:45,492 GYNECOLOGIC RESEARCH AND CAREER 209 00:08:45,492 --> 00:08:48,361 DEVELOPMENT PROGRAMS. AND GHDB 210 00:08:48,361 --> 00:08:50,964 HAS HIGH PROGRAM PRIORITIES. 211 00:08:50,964 --> 00:08:54,334 ONE OF THEM IS TO UNDERSTAND THE 212 00:08:54,334 --> 00:08:59,773 MECHANISMS OF CHRONIC PAIN. 213 00:08:59,773 --> 00:09:06,413 GHDB HAS THREE PROGRAMS THAT 214 00:09:06,413 --> 00:09:07,480 CANDACE WHO HAS BEEN BEEN 215 00:09:07,480 --> 00:09:10,650 OVERSEEING THE ENDOMETRIOSIS, AN 216 00:09:10,650 --> 00:09:14,854 DINO MYOSIS, UNITED STATES RIN 217 00:09:14,854 --> 00:09:15,388 FIBRO 218 00:09:15,388 --> 00:09:18,725 FIBROIDS, MENSTRUATION AND 219 00:09:18,725 --> 00:09:20,093 ENDOMETRIUM PORTFOLIOS AND 220 00:09:20,093 --> 00:09:23,563 DR. M. WHO IS A MEDICAL OFFICER, 221 00:09:23,563 --> 00:09:25,231 SHE HAS BEEN OVERSEEING THE 222 00:09:25,231 --> 00:09:29,736 PELVIC FLOOR DISORDERS. 223 00:09:29,736 --> 00:09:32,038 OBSTETRIC FISTULA AND FEMALE 224 00:09:32,038 --> 00:09:34,674 GENITAL CUTTING PORTFOLIOS AND I 225 00:09:34,674 --> 00:09:35,575 HAVE BEEN OVERSTEEG GYNECOLOGY 226 00:09:35,575 --> 00:09:45,018 PAIN PORTFOLIO. WE RECENTLY 227 00:09:45,018 --> 00:09:45,952 PUBLISHED INFORMATION. 228 00:09:45,952 --> 00:09:48,922 PUBLISHED ON MARCH 18TH, 2024 229 00:09:48,922 --> 00:09:53,359 THIS YEAR. IT'S ABOUT -- IT'S 230 00:09:53,359 --> 00:09:55,929 ACT ENDO PROGRAM AND THE PURPOSE 231 00:09:55,929 --> 00:09:57,597 OF THIS NOTICE SO ALERT THE 232 00:09:57,597 --> 00:09:58,932 COMMUNITY THAT WE PLAN TO 233 00:09:58,932 --> 00:10:01,668 PUBLISH RESEARCH OPPORTUNITY 234 00:10:01,668 --> 00:10:04,037 ANNOUNCEMENT TO INVITE 235 00:10:04,037 --> 00:10:05,572 APPLICATIONS FROM ELIGIBLE 236 00:10:05,572 --> 00:10:08,341 ORGANIZATIONS TO ENGAGE WITH 237 00:10:08,341 --> 00:10:10,977 NICHD TO DEVELOP, ADVANCE AND/OR 238 00:10:10,977 --> 00:10:13,580 VALIDATE NEW DEVICES, BIOMARKERS 239 00:10:13,580 --> 00:10:15,982 AND/OR METHODS OR REPURPOSE 240 00:10:15,982 --> 00:10:17,250 EXISTING DEVICES FOR NONINVASIVE 241 00:10:17,250 --> 00:10:19,352 DIAGNOSIS OF ENDO MEE TROE SIS. 242 00:10:19,352 --> 00:10:23,923 IF YOU HAVE ANY SCIENTIFIC 243 00:10:23,923 --> 00:10:24,591 QUESTIONS INQUIRIES PLEASE 244 00:10:24,591 --> 00:10:28,928 CONTACT DR. TIN GENERAL IF YOU 245 00:10:28,928 --> 00:10:31,564 GO TO THE GHDB WEBSITE YOU CAN 246 00:10:31,564 --> 00:10:34,501 FIND MORE FUNDING OPPORTUNITIES. 247 00:10:34,501 --> 00:10:35,969 THE APPLICATION UNDERSTANDING 248 00:10:35,969 --> 00:10:38,838 CHRONIC CONDITIONS UNDERSTUDIED 249 00:10:38,838 --> 00:10:44,043 AMONG WOMEN R 21 IS ON JUNE 2TH. 250 00:10:44,043 --> 00:10:47,680 AND GHDB IS ALSO PARTICIPATING 251 00:10:47,680 --> 00:10:48,882 IN THE HILL INITIATIVE OF 252 00:10:48,882 --> 00:10:52,085 FUNDING OPPORTUNITIES. SO YOU 253 00:10:52,085 --> 00:10:53,453 CAN PLEASE JEBBING THE 254 00:10:53,453 --> 00:10:56,689 APPLICATION IN THREE DAYS AND IF 255 00:10:56,689 --> 00:11:01,594 YOU GO TO THE HE'LL WEBSITE OR 256 00:11:01,594 --> 00:11:02,228 YOU CAN FIND MORE DETAILED 257 00:11:02,228 --> 00:11:09,969 INFORMATION. AND AND GHDB HAS 258 00:11:09,969 --> 00:11:12,171 ALSO BEEN MANAGING THE BUILDING 259 00:11:12,171 --> 00:11:19,946 IN WOMEN'S CAREER AND HEALTH. 260 00:11:19,946 --> 00:11:25,151 GHDB HAD THE FIRST GYNECOLOGIC 261 00:11:25,151 --> 00:11:27,186 PAIN VIRTUAL MEETING IN 2022 AND 262 00:11:27,186 --> 00:11:29,589 SECOND MEETING IN 2023 LAST YEAR 263 00:11:29,589 --> 00:11:32,392 AND THE GOAL OF THIS MEETING TO 264 00:11:32,392 --> 00:11:39,599 BRING TOGETHER INVEST -- 265 00:11:39,599 --> 00:11:41,167 INVESTIGATORS TO DISCUSS 266 00:11:41,167 --> 00:11:44,037 CHALLENGES, GAPS, AND DIRECTIONS 267 00:11:44,037 --> 00:11:48,074 TO ADDRESS GYNECOLOGIC PAIN 268 00:11:48,074 --> 00:11:51,578 RESEARCH. THIS WORKSHOP, THE 269 00:11:51,578 --> 00:11:54,280 2023 WORKSHOP INVITED SEVEN 270 00:11:54,280 --> 00:11:58,451 SCIENTIFIC SPEAKERS AND THREE 271 00:11:58,451 --> 00:12:01,387 NIH SPEAKERS FROM HEAL AND SEED 272 00:12:01,387 --> 00:12:05,158 AND THE 2023 WORKSHOP WAS 273 00:12:05,158 --> 00:12:12,165 REGISTERED BY OVER 300 PEOPLE. 274 00:12:12,165 --> 00:12:14,100 THE WORKSHOP PROVIDE 275 00:12:14,100 --> 00:12:16,469 OPPORTUNITIES THAT INVESTIGATORS 276 00:12:16,469 --> 00:12:17,070 COULD NETWORK AND COLLABORATE 277 00:12:17,070 --> 00:12:25,945 TOGETHER. AND THIS IS THE THIRD 278 00:12:25,945 --> 00:12:28,781 VIRTUAL PAIN MEETING AND THIS 279 00:12:28,781 --> 00:12:30,116 MEETING WILL COVER THE MAIN 280 00:12:30,116 --> 00:12:32,852 TOPICS RELATED TO GYNECOLOGIC 281 00:12:32,852 --> 00:12:38,658 PAIN INCLUDING ENDOMETRIOSIS, 282 00:12:38,658 --> 00:12:39,692 GYNECOLOGIC PAIN MANAGEMENT OR 283 00:12:39,692 --> 00:12:40,693 TREATMENT AND FOR FDA 284 00:12:40,693 --> 00:12:45,865 REGULATIONS AND GUIDELINES. AND 285 00:12:45,865 --> 00:12:47,533 THEY WILL PROVIDE 286 00:12:47,533 --> 00:12:51,904 AN OVERVIEW OF THE FDA TO HAVE A 287 00:12:51,904 --> 00:12:54,774 VIEW OF GYNECOLOGICAL DEVICES 288 00:12:54,774 --> 00:12:56,976 AND INVESTIGATIONAL NEW DRUG 289 00:12:56,976 --> 00:12:58,845 PROCESSES AS OF THIS MORNING I 290 00:12:58,845 --> 00:13:03,082 HEARD THAT OVER 600 PEOPLE 291 00:13:03,082 --> 00:13:04,083 REGISTERED FOR THIS MEETING. 292 00:13:04,083 --> 00:13:06,219 THIS MEETING IS BEING RECORDED 293 00:13:06,219 --> 00:13:11,891 SO THE RECORDING WITH THE 294 00:13:11,891 --> 00:13:13,059 SPEAKER'S APPROVAL WILL BE 295 00:13:13,059 --> 00:13:14,260 POSTED AFTER THIS MEETING AND 296 00:13:14,260 --> 00:13:16,496 THERE WILL BE A FIVE MINUTE Q&A 297 00:13:16,496 --> 00:13:17,964 AFTER EACH TALK AND A DISCUSSION 298 00:13:17,964 --> 00:13:18,531 SESSION AT THE END OF THE 299 00:13:18,531 --> 00:13:21,768 MEETING. IF YOU HAVE ANY 300 00:13:21,768 --> 00:13:22,802 QUESTIONS, PLEASE COMMIT YOUR 301 00:13:22,802 --> 00:13:25,872 QUESTIONS USING THE Q&A BUTTON 302 00:13:25,872 --> 00:13:30,443 ON THE ZOOM TOOLBAR. AND IF YOU 303 00:13:30,443 --> 00:13:34,180 HAVE ANY TECHNICAL DIFFICULTIES 304 00:13:34,180 --> 00:13:36,516 PLEASE CHAT THE HOST. AND I 305 00:13:36,516 --> 00:13:37,950 WOULD LIKE TO HOST THE GHDB 306 00:13:37,950 --> 00:13:40,553 PLANNING TEAM AND ALSO THE 307 00:13:40,553 --> 00:13:49,128 NICHD. 308 00:13:49,128 --> 00:13:51,297 WE WILL START WITH DR. EMILY 309 00:13:51,297 --> 00:13:53,566 BARTLEY AN ASSISTANT PROFESSOR 310 00:13:53,566 --> 00:13:56,436 IN THE DEPARTMENT OF COMMUNITY 311 00:13:56,436 --> 00:13:57,837 DENTIST INDUSTRY AND BEHAVIOR 312 00:13:57,837 --> 00:13:58,171 SCIENCE. 313 00:13:58,171 --> 00:13:59,372 OR DIRECTOR OF COMMUNICATIONS 314 00:13:59,372 --> 00:14:00,506 AND OUTREACH IN THE PAIN 315 00:14:00,506 --> 00:14:01,841 RESEARCH AND INTERVENTION CENTER 316 00:14:01,841 --> 00:14:05,578 OF EXCELLENCE. AT THE 317 00:14:05,578 --> 00:14:08,047 UNIVERSITY OF FLORIDA. SO 318 00:14:08,047 --> 00:14:09,982 DR. BARTLEY IS GOING TO BE 319 00:14:09,982 --> 00:14:11,517 TALKING ABOUT INSIGHTS INTO 320 00:14:11,517 --> 00:14:12,518 ENDOMETRIOSIS: UNRAVELLING THE 321 00:14:12,518 --> 00:14:14,987 ROLE OF RISK AND RESILIENCE IN 322 00:14:14,987 --> 00:14:16,255 PELVIC PAN -- PAIN AND IF YOU 323 00:14:16,255 --> 00:14:17,256 HAVE QUESTIONS PLEASE PUT THEM 324 00:14:17,256 --> 00:14:18,257 IN THE Q&A AND WE'LL ASK THEM 325 00:14:18,257 --> 00:14:19,926 AFTER. 326 00:14:40,847 --> 00:14:41,481 >> CAN YOU SEE EVERYTHING OKAY? 327 00:14:41,481 --> 00:14:47,787 >> YES. EXCELLENT. HELLO, AND 328 00:14:47,787 --> 00:14:49,689 GOOD AFTERNOON, I AM DELIGHTED 329 00:14:49,689 --> 00:14:50,323 TO BE HERE TODAY TO SPEAK ABOUT 330 00:14:50,323 --> 00:14:54,527 SOME OF OUR RECENT WORK THAT 331 00:14:54,527 --> 00:14:55,161 WE'VE BEEN CONDUCTING IN PELVIC 332 00:14:55,161 --> 00:14:55,828 PAIN IN PARTICULAR, EXPLORING 333 00:14:55,828 --> 00:14:56,496 THE VULNERABILITY AND PROTECTIVE 334 00:14:56,496 --> 00:15:01,667 FACTORS THAT ARE IMPLICATED IN 335 00:15:01,667 --> 00:15:05,071 ENDOMETRIOSIS DISEASE BURDEN 336 00:15:05,071 --> 00:15:06,739 BEFORE I START I HAVE NO 337 00:15:06,739 --> 00:15:07,673 FINANCIAL DISCLOSURES AND MUCH 338 00:15:07,673 --> 00:15:09,475 OF THE WORK THAT I'LL BE TALKING 339 00:15:09,475 --> 00:15:12,512 ABOUT TODAY IS SUPPORTED BY AN R 340 00:15:12,512 --> 00:15:17,917 21 GRANT FUNDED BY NICHD. FOR 341 00:15:17,917 --> 00:15:21,921 OF THOSE WHO ARE UNFAMILIAR 342 00:15:21,921 --> 00:15:23,990 ENDOMETRIOSIS IS AN ESTROGEN 343 00:15:23,990 --> 00:15:25,858 DEPENDENT DISEASE. AND AFFECTS 344 00:15:25,858 --> 00:15:28,161 MORE THAN ONE IN TEN WOMEN WHICH 345 00:15:28,161 --> 00:15:29,929 EQUATES TO AROUND 4 MILLION 346 00:15:29,929 --> 00:15:31,631 WOMEN IN THE UNITED STATES 347 00:15:31,631 --> 00:15:34,534 ALONE. NOW BEYOND AN 348 00:15:34,534 --> 00:15:35,067 INFERTILITY, PAIN IS THE 349 00:15:35,067 --> 00:15:37,603 CARDINAL SYMPTOM OF 350 00:15:37,603 --> 00:15:38,838 ENDOMETRIOSIS AND ONE OF THE 351 00:15:38,838 --> 00:15:40,072 MAIN REASONS WHY WOMEN SEEK 352 00:15:40,072 --> 00:15:41,841 HEALTH CARE I DO WANT TO POINT 353 00:15:41,841 --> 00:15:43,342 OUT THAT PAIN DOESN'T JUST OCCUR 354 00:15:43,342 --> 00:15:47,413 AT THE TIME OF MENSES, 355 00:15:47,413 --> 00:15:51,117 ENDOMETRIOSIS IS ASSOCIATED WITH 356 00:15:51,117 --> 00:15:55,054 A HOST OF OTHER PAIN SYMPTOMS 357 00:15:55,054 --> 00:15:57,423 WHICH IS PAIN DURING DISCOURSE 358 00:15:57,423 --> 00:16:00,960 AND A LARGE OF PORTION OF WOMEN 359 00:16:00,960 --> 00:16:08,034 HAVE A GENERALIZED TYPE OF 360 00:16:08,034 --> 00:16:10,403 PELVIC PAIN. THIS CAN BE LONG 361 00:16:10,403 --> 00:16:13,906 AND FRUSTRATING ESPECIALLY SINCE 362 00:16:13,906 --> 00:16:15,474 DIAGNOSIS CAN TAKE UP TO TEN 363 00:16:15,474 --> 00:16:18,177 YEARS FROM THE ONSET OF 364 00:16:18,177 --> 00:16:19,679 SYMPTOMS. WOMEN EXPERIENCE HIGH 365 00:16:19,679 --> 00:16:21,747 RATES OF DEPRESSION AND POOR 366 00:16:21,747 --> 00:16:23,316 QUALITY OF LIFE AND MUCH OF THIS 367 00:16:23,316 --> 00:16:25,718 STEMS NOT ONLY FROM THE 368 00:16:25,718 --> 00:16:27,253 UNPREDICTABILITY AND DEGREE OF 369 00:16:27,253 --> 00:16:31,023 SYMPTOMS BUT ALSO FROM REPEATED 370 00:16:31,023 --> 00:16:32,725 DISMISSAL FROM THE HEALTH CARE 371 00:16:32,725 --> 00:16:34,794 SYSTEM. THIS IS A HIGHLY 372 00:16:34,794 --> 00:16:37,096 STIGMATIZED CONDITION AND ALSO A 373 00:16:37,096 --> 00:16:38,564 VERY DEBILITATING DISEASE AND 374 00:16:38,564 --> 00:16:40,399 WHEN WE THINK ABOUT THIS FROM A 375 00:16:40,399 --> 00:16:42,501 DISABILITY STANDPOINT, THE 376 00:16:42,501 --> 00:16:44,437 IMPACT OF PAIN CAN BE QUITE 377 00:16:44,437 --> 00:16:46,272 SIGNIFICANT. AND WE'VE EVEN 378 00:16:46,272 --> 00:16:47,807 OBSERVED THIS IN OUR OWN DATA SO 379 00:16:47,807 --> 00:16:49,508 WHAT YOU'RE SEEING HERE IS 380 00:16:49,508 --> 00:16:50,977 SURVEY FINDINGS THAT WE 381 00:16:50,977 --> 00:16:56,082 COLLECTED FROM 100 PEOPLE WITH 382 00:16:56,082 --> 00:16:57,483 PELVIC PAIN. AND WE WERE 383 00:16:57,483 --> 00:17:00,987 INTERESTED IN THE IMPACT OR THE 384 00:17:00,987 --> 00:17:01,787 BURDEN THAT PELVIC PAIN HAS ON 385 00:17:01,787 --> 00:17:03,656 DIFFERENT PARTS OF THEIR LIVES 386 00:17:03,656 --> 00:17:07,026 SUCH AS THEIR ENERGY LEVELS OR 387 00:17:07,026 --> 00:17:09,729 THEIR ABILITY TO GET A GOOD 388 00:17:09,729 --> 00:17:11,731 NIGHT'S SLEEP OR EVEN FUNCTION 389 00:17:11,731 --> 00:17:14,300 ADEQUATELY AT HOME OR AT WORK. 390 00:17:14,300 --> 00:17:16,269 AND WHAT WE'VE FOUND IN THIS 391 00:17:16,269 --> 00:17:19,705 DATA IS THAT AROUND 80% OF WOMEN 392 00:17:19,705 --> 00:17:22,275 REPORT A MODERATE TO HIGH LEVEL 393 00:17:22,275 --> 00:17:24,043 OF PELVIC PAIN IMPACT AGAIN 394 00:17:24,043 --> 00:17:25,778 SUGGESTING THAT THIS IS A 395 00:17:25,778 --> 00:17:27,613 DISEASE ASSOCIATED WITH 396 00:17:27,613 --> 00:17:29,015 TREMENDOUS BURDEN AND WHEN WE 397 00:17:29,015 --> 00:17:31,550 CONSIDER TREATMENTS, THERAPIES 398 00:17:31,550 --> 00:17:33,019 TEND TO BE MORE PERIPHERALLY 399 00:17:33,019 --> 00:17:34,420 BASED STARTING WITH THE 400 00:17:34,420 --> 00:17:36,422 SUPPRESSION OF ESTROGEN LEVELS 401 00:17:36,422 --> 00:17:38,324 AND THIS IS DONE MAINLY THROUGH 402 00:17:38,324 --> 00:17:42,028 HORMONE CONTRACEPTIVES BUT OVER 403 00:17:42,028 --> 00:17:44,664 50% OF WOMEN REPORT PERSISTENT 404 00:17:44,664 --> 00:17:46,732 PAIN AFTER THERAPY ENDS AND FOR 405 00:17:46,732 --> 00:17:51,270 THOSE WHO UNDERGO SURGERY SUCH 406 00:17:51,270 --> 00:17:54,674 AS SURGICAL OBLATION UP TO 50% 407 00:17:54,674 --> 00:17:57,209 HAVE PAIN RECURRENCE BUT 408 00:17:57,209 --> 00:17:59,445 IMPORTANTLY THE STAGE OF 409 00:17:59,445 --> 00:18:00,546 ENDOMETRIOSIS IS NOT REFLECTIVE 410 00:18:00,546 --> 00:18:03,115 OF THE AMOUNT OF PAIN OR THE 411 00:18:03,115 --> 00:18:04,150 DIVERSITY OF SYMPTOMS 412 00:18:04,150 --> 00:18:06,586 EXPERIENCED BY PATIENTS YOU WILL 413 00:18:06,586 --> 00:18:07,920 OFTEN FIND WOMEN WHO HAVE 414 00:18:07,920 --> 00:18:12,858 MINIMAL OR MILD ENDOMETRIOSIS TO 415 00:18:12,858 --> 00:18:15,127 HAVE A HIGH DEGREE OF PAIN. ON 416 00:18:15,127 --> 00:18:17,430 THE OTHER HAND YOU'LL FIND 417 00:18:17,430 --> 00:18:20,299 ASYMPTOMATIC WOMEN WITH SEVERE 418 00:18:20,299 --> 00:18:22,568 ENDOMETRIOSIS BASED ON OBJECTIVE 419 00:18:22,568 --> 00:18:24,003 FINDINGS. THE POINT I WANT TO 420 00:18:24,003 --> 00:18:25,905 MAKE SURE IS THERE IS A HIGH 421 00:18:25,905 --> 00:18:27,606 DEGREE OF VARIABILITY IN 422 00:18:27,606 --> 00:18:34,447 CLINICAL SYMPTOMS AND IT MAY BE 423 00:18:34,447 --> 00:18:37,917 THIS HETEROGENEITY IN THIS. SO 424 00:18:37,917 --> 00:18:39,352 THIS HAS BEEN A GOAL THAT MY 425 00:18:39,352 --> 00:18:40,686 COLLEAGUES AND I HAVE BEEN 426 00:18:40,686 --> 00:18:41,320 WORKING ON IS TO BETTER 427 00:18:41,320 --> 00:18:43,089 UNDERSTAND THE FACTORS THAT 428 00:18:43,089 --> 00:18:45,257 CONTRIBUTE TO ENDOMETRIOSIS PAIN 429 00:18:45,257 --> 00:18:46,592 AND ALSO HAVE A BETTER 430 00:18:46,592 --> 00:18:48,361 UNDERSTANDING OF HIGH THESE 431 00:18:48,361 --> 00:18:51,430 FACTORS SPECIFICALLY IMPACT 432 00:18:51,430 --> 00:18:55,701 TREATMENT. SO THERE'S BEEN A 433 00:18:55,701 --> 00:19:00,072 SMALL HANDFUL OF STUDIES IN 434 00:19:00,072 --> 00:19:01,207 RESPONSE TO TREATMENT. THIS IS 435 00:19:01,207 --> 00:19:02,942 AN EXAMPLE OF SOME OF THOSE 436 00:19:02,942 --> 00:19:04,343 PREDICTORS BUT I WANT TO POINT 437 00:19:04,343 --> 00:19:06,812 OUT THAT A LOT OF FACTORS LIKE 438 00:19:06,812 --> 00:19:08,047 THESE ARE NOT OFTEN CONSIDERED 439 00:19:08,047 --> 00:19:10,683 IN ROUTINE ASSESSMENT PRACTICES. 440 00:19:10,683 --> 00:19:13,919 AND MANY STUDIES TEND TO REALLY 441 00:19:13,919 --> 00:19:16,789 FOCUS ON SOCIODEMOGRAPHIC OR 442 00:19:16,789 --> 00:19:17,523 CLINICAL PREDICTORS SO THIS HAS 443 00:19:17,523 --> 00:19:19,125 BEEN A PARTICULAR FOCAL POINT 444 00:19:19,125 --> 00:19:20,960 FOR US AND THAT'S REALLY TO KIND 445 00:19:20,960 --> 00:19:22,728 OF MOVE BEYOND SOME OF THE MORE 446 00:19:22,728 --> 00:19:24,296 TRADITIONAL FACTORS THAT HAVE 447 00:19:24,296 --> 00:19:26,332 BEEN EXAMINED AND IDENTIFY 448 00:19:26,332 --> 00:19:27,833 VARIOUS PSYCHOSOCIAL AND 449 00:19:27,833 --> 00:19:29,335 BEHAVIORAL MECHANISMS THAT HAVE 450 00:19:29,335 --> 00:19:31,470 BEEN RELATIVELY UNDEREXPLORED IN 451 00:19:31,470 --> 00:19:33,673 THE ENDOMETRIOSIS DOMAIN. 452 00:19:33,673 --> 00:19:37,910 BUT WHEN WE LOOK AT THE LARGER 453 00:19:37,910 --> 00:19:44,283 PAIN LITERATURE, THESE ARE ALSO 454 00:19:44,283 --> 00:19:46,552 FACTORS THAT HAVE RELIABLE 455 00:19:46,552 --> 00:19:47,353 PREDICTABILITY IN ORDER TO 456 00:19:47,353 --> 00:19:48,888 PREDICT CHRONIC PAIN AND 457 00:19:48,888 --> 00:19:51,123 DISABILITY. I AM GOING TO SHOW 458 00:19:51,123 --> 00:19:53,192 YOU SOME DATA THAT ILLUSTRATES 459 00:19:53,192 --> 00:19:55,327 THE ASSOCIATIONS THAT WE HAVE 460 00:19:55,327 --> 00:19:56,162 OBSERVED. THIS IS FROM OUR OWN 461 00:19:56,162 --> 00:19:57,797 INTERNAL DATA. AND IT'S TAKEN 462 00:19:57,797 --> 00:20:04,003 FROM A COMMUNITY-BASED SAMPLE 463 00:20:04,003 --> 00:20:04,670 REPORTING ENDOMETRIOSIS AND WE 464 00:20:04,670 --> 00:20:05,871 EXAMINE VARIOUS CHARACTERISTICS 465 00:20:05,871 --> 00:20:08,541 ACROSS LEVELS OF PAIN IMPACT. 466 00:20:08,541 --> 00:20:11,210 SO VARIOUS DEMOGRAPHIC, 467 00:20:11,210 --> 00:20:12,511 BEHAVIORAL, AND PSYCH COLLEGE 468 00:20:12,511 --> 00:20:17,049 CALENDAR CHARACTERISTICS WELLS, 469 00:20:17,049 --> 00:20:20,519 THE QUALITY OF PAIN THAT WOMEN 470 00:20:20,519 --> 00:20:22,388 EXPERIENCE. WHAT WE FOUND IS 471 00:20:22,388 --> 00:20:23,622 THAT WOMEN WHO REPORT GREATER 472 00:20:23,622 --> 00:20:25,925 PAIN IMPACT, SO THESE ARE WOMEN 473 00:20:25,925 --> 00:20:28,194 WHO HAVE A HIGH DEGREE OF BURDEN 474 00:20:28,194 --> 00:20:30,563 AND ACTIVITIES OF DAILY LIVING. 475 00:20:30,563 --> 00:20:34,366 OR EVEN SOCIAL AND WORK 476 00:20:34,366 --> 00:20:39,438 RELATIONSHIPS. ASSOCIATED WITH 477 00:20:39,438 --> 00:20:42,641 THEIR PAIN HAVE A HIGHER BODY 478 00:20:42,641 --> 00:20:46,178 MASS INDEX, REPORT GREATER 479 00:20:46,178 --> 00:20:49,115 SYMPTOMS OF PAIN AND HIGHER 480 00:20:49,115 --> 00:20:51,117 RATES OF SLEEP DISTURBANCE WHEN 481 00:20:51,117 --> 00:20:53,252 YOU LOOK AT THIS FROM A 482 00:20:53,252 --> 00:20:54,353 PSYCHOLOGICAL STANDPOINT THEY 483 00:20:54,353 --> 00:20:56,655 ALSO REPORT A GREATER DEGREE OF 484 00:20:56,655 --> 00:20:59,024 NEGATIVE PSYCHOLOGICAL 485 00:20:59,024 --> 00:21:01,627 FUNCTIONING SUCH AS ANXIETY AND 486 00:21:01,627 --> 00:21:03,596 DEPRESSION AS WELL AS LOWER 487 00:21:03,596 --> 00:21:04,897 LEVELS OF PROTECTIVE RESOURCES 488 00:21:04,897 --> 00:21:09,935 SUCH AS OPTIMISM. SO WHAT THESE 489 00:21:09,935 --> 00:21:11,270 FINDINGS TELL US IS THAT THERE 490 00:21:11,270 --> 00:21:16,175 ARE MULTIPLE FACTORS THAT VARY 491 00:21:16,175 --> 00:21:17,443 WHICH MAY CONTRIBUTE TO 492 00:21:17,443 --> 00:21:19,011 ALTERATIONS IN PAIN PROCESSING 493 00:21:19,011 --> 00:21:21,847 THAT YOU SEE IN ENDOMETRIOSIS. 494 00:21:21,847 --> 00:21:23,916 SO ANOTHER AREA THAT WE HAVE 495 00:21:23,916 --> 00:21:26,085 BEEN EXPLORING IS THE PRESENCE 496 00:21:26,085 --> 00:21:28,621 OF OVERLAPPING PAIN. AND IT'S 497 00:21:28,621 --> 00:21:31,924 PROBABLY NO SURPRISE THAT 498 00:21:31,924 --> 00:21:33,926 ENDOMETRIOSIS HAS A HIGH DEGREE 499 00:21:33,926 --> 00:21:37,329 OF COPREVALENCE WITH OTHER PAIN 500 00:21:37,329 --> 00:21:38,864 CONDITIONS IN PARTICULAR CHRONIC 501 00:21:38,864 --> 00:21:42,301 OVERLAPPING CONDITIONS YOU MAY 502 00:21:42,301 --> 00:21:45,437 HAVE HEARD THESE CALLS COPCS. 503 00:21:45,437 --> 00:21:46,672 THESE REPRESENT A COLLECTION OF 504 00:21:46,672 --> 00:21:49,108 TEN DISORDERS THAT OCCUR 505 00:21:49,108 --> 00:21:51,911 FREQUENTLY IN THE POPULATION BUT 506 00:21:51,911 --> 00:21:53,646 WHOSE UNDERLYING PATHOPHYSIOLOGY 507 00:21:53,646 --> 00:22:01,120 REMAINS VERY POORLY UNDERSTOOD. 508 00:22:01,120 --> 00:22:05,758 THESE CONDITIONS CONTAIN A HIGH 509 00:22:05,758 --> 00:22:06,458 MORBIDITY. WHICH MEANS ONE 510 00:22:06,458 --> 00:22:08,160 MEANS ANOTHER. A GREATER 511 00:22:08,160 --> 00:22:08,861 PREVALENCE OF THESE CONDITIONS 512 00:22:08,861 --> 00:22:11,497 IS ASSOCIATED WITH A HIGHER 513 00:22:11,497 --> 00:22:14,200 FREQUENCY AND DURATION OF PELVIC 514 00:22:14,200 --> 00:22:16,168 PAIN EPISODES. THEY'RE 515 00:22:16,168 --> 00:22:17,903 ASSOCIATED WITH GREATER 516 00:22:17,903 --> 00:22:21,473 ENDOMETRIOSIS PAIN SEVERITY AND 517 00:22:21,473 --> 00:22:23,008 MORE FREQUENT DYSMENORRHEA AND 518 00:22:23,008 --> 00:22:25,644 IMPAIRMENTS OF ACTIVITIES IN 519 00:22:25,644 --> 00:22:27,413 DAILY LIVING. IN OUR OWN DATA 520 00:22:27,413 --> 00:22:29,348 WE OBSERVE THAT WOMEN WHO HAVE A 521 00:22:29,348 --> 00:22:32,785 GREATER NUMBER OF THESE SYMPTOMS 522 00:22:32,785 --> 00:22:35,354 ALSO SELF-REPORT GREATER 523 00:22:35,354 --> 00:22:39,225 SYMPTOMS OF CENTRAL 524 00:22:39,225 --> 00:22:40,559 DECENTIIZATION. THAT 525 00:22:40,559 --> 00:22:41,660 SENSITIVITY MAY PLAY A CENTRAL 526 00:22:41,660 --> 00:22:41,860 ROLE. 527 00:22:41,860 --> 00:22:47,266 WE HAVE TAKEN THIS A STEP 528 00:22:47,266 --> 00:22:50,469 FURTHER AND EXAMINED HOW THIS IS 529 00:22:50,469 --> 00:22:53,572 PELVIC PAIN BASED ON WHETHER OR 530 00:22:53,572 --> 00:22:56,342 NOT ENDOMETRIOSIS IS PRESENT. 531 00:22:56,342 --> 00:22:58,711 THIS IS BASED ON A SAMPLE OF 125 532 00:22:58,711 --> 00:23:03,649 WOMEN WITH CHRONIC PAIN. 25% OF 533 00:23:03,649 --> 00:23:05,284 HAVING REPORTED ENDOMETRIOSIS 534 00:23:05,284 --> 00:23:07,553 AND WE CHARACTERIZED DIFFERENCES 535 00:23:07,553 --> 00:23:08,554 IN PAIN BETWEEN THESE TWO GROUPS 536 00:23:08,554 --> 00:23:11,290 AND EXAMINED THE INFLUENCE OF 537 00:23:11,290 --> 00:23:13,993 COPCS ON PAIN. SO TO ORIENT 538 00:23:13,993 --> 00:23:16,528 YOU, WOMEN WITH ENDOMETRIOSIS 539 00:23:16,528 --> 00:23:18,964 ARE SIGNIFIED BY THE GOLD BAR 540 00:23:18,964 --> 00:23:21,100 AND THE BAR IN BLUE REPRESENTS 541 00:23:21,100 --> 00:23:23,002 WOMEN WHO HAVE CHRONIC PELVIC 542 00:23:23,002 --> 00:23:25,971 PAIN BUT DO NOT HAVE 543 00:23:25,971 --> 00:23:27,206 ENDOMETRIOSIS AND WHEN YOU 544 00:23:27,206 --> 00:23:28,907 COMPARE THESE TWO GROUPS 545 00:23:28,907 --> 00:23:31,644 TOGETHER. WOMEN WITH 546 00:23:31,644 --> 00:23:32,111 ENDOMETRIOSIS REPORT 547 00:23:32,111 --> 00:23:33,545 SIGNIFICANTLY GREATER LEVELS OF 548 00:23:33,545 --> 00:23:36,448 PELVIC PAIN SEVERITY AND 549 00:23:36,448 --> 00:23:37,716 INTERFERENCE FROM PAIN AND THEY 550 00:23:37,716 --> 00:23:43,088 ALSO REPORT GREATER OVERALL PAIN 551 00:23:43,088 --> 00:23:45,591 IMPACT. AND THESE WOMEN ALSO 552 00:23:45,591 --> 00:23:49,962 HAVE A HIGHER PREVALENCE OF 553 00:23:49,962 --> 00:23:50,896 COPCS AND IN PARTICULAR THEY 554 00:23:50,896 --> 00:23:52,865 REPORT HIGHER RATES OF CHRONIC 555 00:23:52,865 --> 00:23:57,202 FATIGUE SYNDROME, FIBROMYALGIA 556 00:23:57,202 --> 00:23:59,772 AND TAN DO MANDIBULAR DISORDER 557 00:23:59,772 --> 00:24:01,573 AND AROUND ONE QUARTER ALSO 558 00:24:01,573 --> 00:24:03,108 REPORT THREE OR MORE OVERLAPPING 559 00:24:03,108 --> 00:24:04,576 PAIN CONDITIONS. 560 00:24:04,576 --> 00:24:09,214 AND THIS IS RELATIVE TO ONLY 12% 561 00:24:09,214 --> 00:24:12,551 OF WOMEN WHO JUST STRICTLY HAVE 562 00:24:12,551 --> 00:24:14,586 CHRONIC PAIN AND SO TAKING ALL 563 00:24:14,586 --> 00:24:16,322 OF THIS TOGETHER, WHAT DID THIS 564 00:24:16,322 --> 00:24:18,357 MEAN? I THINK FIRST WE NEED TO 565 00:24:18,357 --> 00:24:20,492 KIND OF TAKE A STEP BACK AND ASK 566 00:24:20,492 --> 00:24:22,027 OURSELVES WHY DO OUR CURRENT 567 00:24:22,027 --> 00:24:25,097 TREATMENTS NOT WORK VERY WELL 568 00:24:25,097 --> 00:24:29,835 FOR THIS CONDITION? 569 00:24:29,835 --> 00:24:31,103 ENDOMETRIOSIS HAS BEEN 570 00:24:31,103 --> 00:24:33,605 CHARACTERIZED AS HAVING THIS 571 00:24:33,605 --> 00:24:37,009 MULTIFACTORIAL ETIOLOGY THAT NOT 572 00:24:37,009 --> 00:24:40,446 ONLY INCLUDES PERIPHERAL 573 00:24:40,446 --> 00:24:42,981 MODULATORS BUT MECHANISMS THAT 574 00:24:42,981 --> 00:24:45,884 MONITOR PAIN AND IT COULD BE 575 00:24:45,884 --> 00:24:47,686 THAT WE'RE MISSING CONTRIBUTOR 576 00:24:47,686 --> 00:24:49,922 TO PAIN THAT ARE NOT OFTEN 577 00:24:49,922 --> 00:24:50,756 CONSIDERED AND THIS IS 578 00:24:50,756 --> 00:24:54,326 ESPECIALLY SALIENT GIVEN THE 579 00:24:54,326 --> 00:24:57,396 DISCREPANCY BETWEEN SYMPTOM 580 00:24:57,396 --> 00:24:59,264 SEVERITY AND DISEASE BURDEN. 581 00:24:59,264 --> 00:25:00,299 THIS HAS BEEN THIS GROWING 582 00:25:00,299 --> 00:25:05,971 INTEREST IN USING 583 00:25:05,971 --> 00:25:06,739 MULTIDIMENSIONAL DATA TO SEE 584 00:25:06,739 --> 00:25:09,308 DISEASE IN PATTERNS OF DISEASE 585 00:25:09,308 --> 00:25:11,677 PRESENTATION AND COMORBIDITIES 586 00:25:11,677 --> 00:25:13,145 WHICH COULD POTENTIALLY BE AN 587 00:25:13,145 --> 00:25:16,749 AVENUE TOWARDS GREATER 588 00:25:16,749 --> 00:25:20,486 PERSONALIZED MEDICINE. AND SO I 589 00:25:20,486 --> 00:25:21,653 PUT A QUESTION MARK ON THIS 590 00:25:21,653 --> 00:25:23,455 TITLE BECAUSE I THINK THIS IS AN 591 00:25:23,455 --> 00:25:25,758 AREA THAT HOLDS A LOT OF PROMISE 592 00:25:25,758 --> 00:25:27,760 BUT ALSO STILL IN ITS INFANCY 593 00:25:27,760 --> 00:25:29,461 AND THERE'S STILL A LOT THAT WE 594 00:25:29,461 --> 00:25:30,896 REALLY DON'T KNOW ABOUT THE 595 00:25:30,896 --> 00:25:33,565 CHARACTERIZATION OF 596 00:25:33,565 --> 00:25:34,400 ENDOMETRIOSIS. SO WE'VE 597 00:25:34,400 --> 00:25:36,101 ACTUALLY BEEN TRYING TO TACKLE 598 00:25:36,101 --> 00:25:37,836 THIS A LITTLE BIT. AND I WANT 599 00:25:37,836 --> 00:25:41,907 TO BRIEFLY TOUCH UPON THE R21 600 00:25:41,907 --> 00:25:43,075 STUDY THAT WE ARE CURRENTLY 601 00:25:43,075 --> 00:25:44,009 CONDUCTING WHERE WE'VE BEEN 602 00:25:44,009 --> 00:25:47,980 TRYING TO ADDRESS THIS ISSUE BY 603 00:25:47,980 --> 00:25:50,783 EXPLORING PHENOTYPIC PREDICTORS 604 00:25:50,783 --> 00:25:51,550 ASSOCIATED WITH PELVIC PAIN 605 00:25:51,550 --> 00:25:54,253 IMPACT AND PHYSICAL FUNCTIONING 606 00:25:54,253 --> 00:25:56,755 IN PATIENTS WHO HAVE CLINICALLY 607 00:25:56,755 --> 00:25:59,725 SUSPECTED ENDOMETRIOSIS BUT WHO 608 00:25:59,725 --> 00:26:01,794 ARE UNDERGOING CONSERVATIVE 609 00:26:01,794 --> 00:26:02,694 MEDICAL MANAGEMENT OF THE 610 00:26:02,694 --> 00:26:04,329 DISEASE AND WHAT WE'RE DOING IN 611 00:26:04,329 --> 00:26:05,497 THIS STUDY IS WE'RE FOLLOWING 612 00:26:05,497 --> 00:26:08,700 WOMEN FOR AROUND SIX MONTH TO 613 00:26:08,700 --> 00:26:09,935 IDENTIFY WHETHER THERE ARE 614 00:26:09,935 --> 00:26:11,937 SPECIFIC FACTORS THAT TEND TO 615 00:26:11,937 --> 00:26:13,472 CLUSTER TOGETHER TO PREDICT HOW 616 00:26:13,472 --> 00:26:19,978 WELL ONE DOES ON THESE TYPES OF 617 00:26:19,978 --> 00:26:24,416 THERAPIES. INCLUDING HOW 618 00:26:24,416 --> 00:26:26,819 PHENOTYPES WORK OVER TIME. 619 00:26:26,819 --> 00:26:27,419 WE'RE WORKING ACROSS SEVERAL 620 00:26:27,419 --> 00:26:29,087 BROAD DOMAINS SUCH AS YOU SEE 621 00:26:29,087 --> 00:26:31,690 HERE AND ALTHOUGH THIS IS NOT AN 622 00:26:31,690 --> 00:26:32,357 EXHAUSTIVE LIST THESE ARE SOME 623 00:26:32,357 --> 00:26:33,859 EXAMPLES OF THE FACTORS THAT 624 00:26:33,859 --> 00:26:36,361 WE'RE INTERESTED IN SUCH AS 625 00:26:36,361 --> 00:26:40,032 VARIOUS DEMOGRAPHIC FACTORS, 626 00:26:40,032 --> 00:26:43,902 HEALTH AND PAIN COMORBIDITIES. 627 00:26:43,902 --> 00:26:45,304 SLEEP QUALITY, PSYCHOLOGICAL 628 00:26:45,304 --> 00:26:49,174 RISK AND RESILIENCE FACTORS AS 629 00:26:49,174 --> 00:26:50,742 WELL. NOW, WE'RE AT THE VERY 630 00:26:50,742 --> 00:26:52,211 EARLY STAGE OF THE DATA 631 00:26:52,211 --> 00:26:54,246 COLLECTION, BUT I WANTED TO 632 00:26:54,246 --> 00:26:55,581 PROVIDE A SNAPSHOT OF WHAT WE'VE 633 00:26:55,581 --> 00:26:58,584 BEEN FINDING SO FAR SO THESE ARE 634 00:26:58,584 --> 00:27:00,018 DATA REPRESENTING PELVIC PAIN 635 00:27:00,018 --> 00:27:04,156 IMPACT AND PHYSICAL FUNCTIONING. 636 00:27:04,156 --> 00:27:06,091 AND DEPICT CHANGE IN THE OVERALL 637 00:27:06,091 --> 00:27:07,693 COMBINED SAMPLE OVER THE SIX 638 00:27:07,693 --> 00:27:09,928 MONTH PERIOD SO WHAT YOU'RE 639 00:27:09,928 --> 00:27:11,530 SEEING HERE IS THAT THE SLOPE OF 640 00:27:11,530 --> 00:27:13,832 THIS CHANGE IS NOT SIGNIFICANTLY 641 00:27:13,832 --> 00:27:16,068 DIFFERENT FROM ZERO FOR EITHER 642 00:27:16,068 --> 00:27:19,338 PAIN IMPACT OR PHYSICAL 643 00:27:19,338 --> 00:27:24,309 FUNCTION. BUT WHAT'S 644 00:27:24,309 --> 00:27:26,345 INTERESTING ABOUT THIS IS WHEN 645 00:27:26,345 --> 00:27:29,147 YOU LOOK AT INDEPENDENT PAIN 646 00:27:29,147 --> 00:27:31,416 SLOPES SIX MONTH CHANGE VARIES 647 00:27:31,416 --> 00:27:32,851 DRAMATICALLY. THERE'S 648 00:27:32,851 --> 00:27:34,253 IMPROVEMENTS OVER TIME IN THE 649 00:27:34,253 --> 00:27:37,022 PAIN SYMPTOMS. SOME TEND TO BE 650 00:27:37,022 --> 00:27:38,991 RELATIVELY STABLE OVER THE SIX 651 00:27:38,991 --> 00:27:40,459 MONTH TIME COURSE. WHEREAS 652 00:27:40,459 --> 00:27:42,494 OTHERS HAVE WORSENING 653 00:27:42,494 --> 00:27:44,029 TRAJECTORIES, SO THEIR PAIN 654 00:27:44,029 --> 00:27:44,963 IMPACT AND THEIR PHYSICAL 655 00:27:44,963 --> 00:27:47,633 FUNCTION AND ACTUALLY GETS WORSE 656 00:27:47,633 --> 00:27:50,302 OVER TIME. SO WHAT THIS 657 00:27:50,302 --> 00:27:51,803 ILLUSTRATES IS THAT PATTERNS OF 658 00:27:51,803 --> 00:27:55,440 CHANGE IN THESE SYMPTOMS VARY 659 00:27:55,440 --> 00:27:58,410 AMONG ENDOMETRIOSIS PATIENTS 660 00:27:58,410 --> 00:27:59,711 SUGGESTING THAT THERE IS A HIGH 661 00:27:59,711 --> 00:28:03,181 DEGREE OF VARIABILITY IN PAIN 662 00:28:03,181 --> 00:28:05,584 ASSOCIATED WITH TREATMENT. SO 663 00:28:05,584 --> 00:28:09,922 TO KIND OF SUM UP EVERYTHING, 664 00:28:09,922 --> 00:28:11,823 ENDOMETRIOSIS IS HIGHLY 665 00:28:11,823 --> 00:28:13,926 HETEROGENOUS, NOT ONLY IN 666 00:28:13,926 --> 00:28:14,593 PRESENTATION BUT ALSO IN 667 00:28:14,593 --> 00:28:17,362 TREATMENT EFFICACY. AND WHILE 668 00:28:17,362 --> 00:28:19,598 THIS DISEASE HAS PREDOMINANTLY 669 00:28:19,598 --> 00:28:29,908 BEEN CONCEPTUALIZED A PERIPHERAL 670 00:28:29,908 --> 00:28:32,244 CONDITION THERE'S OTHER THAN 671 00:28:32,244 --> 00:28:33,679 PERIPHERAL DAMAGE: SO MOVING 672 00:28:33,679 --> 00:28:35,581 FORWARD, IF WE THINK ABOUT, YOU 673 00:28:35,581 --> 00:28:37,716 KNOW, HOW CAN WE IMPROVE OUR 674 00:28:37,716 --> 00:28:40,786 UNDERSTANDING OF ENDOMETRIOSIS. 675 00:28:40,786 --> 00:28:42,287 IT MAY BE THAT AN IMPORTANT 676 00:28:42,287 --> 00:28:47,159 DIRECTIVE IS TO CONSIDER AND 677 00:28:47,159 --> 00:28:47,626 IDENTIFY SOME OF THE 678 00:28:47,626 --> 00:28:49,528 CHARACTERISTICS THAT PREDICT 679 00:28:49,528 --> 00:28:50,762 THIS VARIABILITY BECAUSE THIS 680 00:28:50,762 --> 00:28:53,131 MAY BE A REALLY CRITICAL STEP 681 00:28:53,131 --> 00:28:55,734 TOWARDS INDIVIDUALIZING AND 682 00:28:55,734 --> 00:29:01,173 IMPROVING PATIENT CARE FOR THIS 683 00:29:01,173 --> 00:29:03,041 POPULATION. SO BEFORE I CLOSE I 684 00:29:03,041 --> 00:29:04,576 WANT TO ACKNOWLEDGE MY 685 00:29:04,576 --> 00:29:05,711 COLLABORATORS AND MY LAB AT THE 686 00:29:05,711 --> 00:29:07,646 UNIVERSITY OF FLORIDA AND THE 687 00:29:07,646 --> 00:29:10,882 ORLANDO VA. AS WELL AS NIH FOR 688 00:29:10,882 --> 00:29:13,385 THEIR SUSTAINED SUPPORT 689 00:29:13,385 --> 00:29:16,054 INCLUDING NICHD FOR FUNDING MUCH 690 00:29:16,054 --> 00:29:19,491 OF THE WORK THAT I HAVE 691 00:29:19,491 --> 00:29:22,728 DISCUSSED TODAY. THANK YOU. 692 00:29:22,728 --> 00:29:23,762 >> THANK YOU SO MUCH, 693 00:29:23,762 --> 00:29:26,865 DRDR. P 694 00:29:26,865 --> 00:29:29,067 DR. BARTLEY, QUESTIONS CAN BE 695 00:29:29,067 --> 00:29:31,036 PLACED IN THE Q&A TOOL. I 696 00:29:31,036 --> 00:29:32,571 THOUGHT THIS WAS AN INTERESTING 697 00:29:32,571 --> 00:29:34,773 TALK BECAUSE IT TALKS ABOUT THE 698 00:29:34,773 --> 00:29:36,642 CONNECTION BETWEEN THE MIND AND 699 00:29:36,642 --> 00:29:38,477 BODY. NOT ONLY JUST THE NEURONS 700 00:29:38,477 --> 00:29:39,911 AND HOW THEY CONNECT TO THE 701 00:29:39,911 --> 00:29:42,214 EXPERIENCE OF PAIN BUT ALSO HOW 702 00:29:42,214 --> 00:29:43,915 THE EXPERIENCE OF PAIN CAN BE 703 00:29:43,915 --> 00:29:45,917 DIFFERENT BASED ON THAT. I'M 704 00:29:45,917 --> 00:29:46,985 WONDERING YOU BROUGHT IT UP ON 705 00:29:46,985 --> 00:29:48,520 ONE SLIDE ABOUT DIAGNOSIS AND IT 706 00:29:48,520 --> 00:29:50,689 MADE ME WONDER, IS THERE ANY 707 00:29:50,689 --> 00:29:53,191 LITERATURE OUT THERE OR ANY DATA 708 00:29:53,191 --> 00:29:55,661 ON THE EXPERIENCE OF PAIN PRE 709 00:29:55,661 --> 00:29:57,262 AND POST-DIAGNOSIS? I'M 710 00:29:57,262 --> 00:29:59,765 WONDERING IF BEING ABLE TO NAME 711 00:29:59,765 --> 00:30:01,433 IT AND UNDERSTAND IT, IF THAT 712 00:30:01,433 --> 00:30:03,168 CHANGES THE EXPERIENCE OF PAIN 713 00:30:03,168 --> 00:30:07,973 FOR, SAY, ENDOMETRIOSIS? 714 00:30:07,973 --> 00:30:11,510 >> LIKE ARE YOU ASKING, LIKE IS 715 00:30:11,510 --> 00:30:13,845 THE, IS THAT CRITICAL TOWARDS 716 00:30:13,845 --> 00:30:16,048 HOW A PATIENT KIND OF 717 00:30:16,048 --> 00:30:17,382 UNDERSTANDS AND APPRECIATES, YOU 718 00:30:17,382 --> 00:30:18,817 KNOW, HER PAIN EXPERIENCE AND 719 00:30:18,817 --> 00:30:19,685 MOVING FORWARD? 720 00:30:19,685 --> 00:30:22,921 >> YEAH, I WONDERED IF -- IF ANY 721 00:30:22,921 --> 00:30:26,491 OF YOUR DATA OR THESE THINGS 722 00:30:26,491 --> 00:30:29,327 LOOK AT WOMEN WITH PUNITIVE 723 00:30:29,327 --> 00:30:29,995 ENDOMETRIOSIS RATHER THAN 724 00:30:29,995 --> 00:30:32,064 DIAGNOSED ENDOMETRIOSIS AND 725 00:30:32,064 --> 00:30:33,799 WOULD THERE BE DIFFERENCES THERE 726 00:30:33,799 --> 00:30:35,701 BASED ON NOT REALLY KNOWING YET 727 00:30:35,701 --> 00:30:37,202 THEIR DIAGNOSIS AND YET KNOWING 728 00:30:37,202 --> 00:30:38,203 SOMETHING IS WRONG. 729 00:30:38,203 --> 00:30:39,771 >> YEAH, ABSOLUTELY. YOU KNOW, 730 00:30:39,771 --> 00:30:41,907 WE HAVE NOT LOOKED AT THAT IN 731 00:30:41,907 --> 00:30:44,676 OUR OWN DATA BUT, YOU KNOW, I 732 00:30:44,676 --> 00:30:48,213 THINK JUST KNOWING IS SO 733 00:30:48,213 --> 00:30:49,748 INCREDIBLY IMPORTANT AND THE 734 00:30:49,748 --> 00:30:53,919 FACT THAT THESE WOMEN HAVE TO GO 735 00:30:53,919 --> 00:30:55,921 THROUGH YEARS OF SEEING MEDICAL 736 00:30:55,921 --> 00:30:56,588 PROFESSIONAL AFTER MEDICAL 737 00:30:56,588 --> 00:30:59,324 PROFESSIONAL AND NOT KNOWING 738 00:30:59,324 --> 00:31:02,794 WHAT EXACTLY IS GOING ON I THINK 739 00:31:02,794 --> 00:31:05,964 CAN BE VERY DETRIMENTAL TO 740 00:31:05,964 --> 00:31:08,567 PSYCHOLOGICAL AND PHYSICAL 741 00:31:08,567 --> 00:31:10,135 HEALTH AND MOST CERTAINLY IT 742 00:31:10,135 --> 00:31:11,536 DOES IMPACT THE PAIN EXPERIENCE 743 00:31:11,536 --> 00:31:13,138 IN SOME WAY AND WE KNOW THAT 744 00:31:13,138 --> 00:31:16,341 THERE IS A HUGE LITERATURE ON 745 00:31:16,341 --> 00:31:17,409 JUST HOW OUR BELIEFS, THE WAY 746 00:31:17,409 --> 00:31:22,647 THAT WE THINK ABOUT THINGS, OUR 747 00:31:22,647 --> 00:31:24,049 PSYCHOLOGICAL STATE CAN IMPACT 748 00:31:24,049 --> 00:31:25,717 THE EXPERIENCE OVERALL AND JUST 749 00:31:25,717 --> 00:31:27,018 BECAUSE IT IS A HIGHLY 750 00:31:27,018 --> 00:31:29,955 STIGMATIZED CONDITION AND IF 751 00:31:29,955 --> 00:31:31,456 YOU'RE NOT GETTING THAT 752 00:31:31,456 --> 00:31:34,392 VALIDATION FROM OTHER PEOPLE, I 753 00:31:34,392 --> 00:31:37,362 THINK CAN BE INCREDIBLY HARMFUL 754 00:31:37,362 --> 00:31:39,030 SO I THINK SOMEBODY PUT THIS IN 755 00:31:39,030 --> 00:31:41,166 THE CHAT AND I RESONATE WITH 756 00:31:41,166 --> 00:31:45,070 THIS. I THINK IT'S SUCH AN 757 00:31:45,070 --> 00:31:46,371 IMPORTANT STATEMENT THAT JUST 758 00:31:46,371 --> 00:31:47,405 KNOWING THE DIAGNOSIS IS SO 759 00:31:47,405 --> 00:31:50,075 INCREDIBLY HEALING. 760 00:31:50,075 --> 00:31:52,010 >> AND CAN YOU SPEAK TO I THINK 761 00:31:52,010 --> 00:31:53,378 SOME OF THE RISKS WERE REALLY 762 00:31:53,378 --> 00:31:54,679 CLEAR, CAN YOU SPEAK TO SOME OF 763 00:31:54,679 --> 00:31:56,348 THE RESILIENCE SOME OF THE 764 00:31:56,348 --> 00:32:00,318 FACTORS THAT REALLY LEAD TO 765 00:32:00,318 --> 00:32:01,920 RESILIENCE IN THE EXPERIENCE OF 766 00:32:01,920 --> 00:32:03,822 PAI 767 00:32:03,822 --> 00:32:04,022 PAIN? 768 00:32:04,022 --> 00:32:05,991 >> YEAH, THIS IS AN AREA WE'RE 769 00:32:05,991 --> 00:32:08,960 DIVING INTO AND WE LOOKED AT 770 00:32:08,960 --> 00:32:10,462 PELVIC PAIN SEVERITY AND 771 00:32:10,462 --> 00:32:11,263 DISABILITY IN THIS POPULATION. 772 00:32:11,263 --> 00:32:14,099 WE SEE A LOT OF VARIOUS 773 00:32:14,099 --> 00:32:16,067 PSYCHOSOCIAL FACTORS THAT ARE 774 00:32:16,067 --> 00:32:18,203 ASSOCIATED WITH KIND OF LOWER 775 00:32:18,203 --> 00:32:23,008 LEVELS OF DISABILITY. SO LIKE I 776 00:32:23,008 --> 00:32:26,344 SHOWED YOU OPTIMISM BUT WE ALSO 777 00:32:26,344 --> 00:32:28,180 LOOKED AT STRESS RESILIENCE 778 00:32:28,180 --> 00:32:29,881 FROM, THERE'S JUST SOME VARIOUS 779 00:32:29,881 --> 00:32:33,518 MEASURES THAT CAN EXAMINE THIS, 780 00:32:33,518 --> 00:32:36,087 WE -- FROM THE RESILIENCE SCALE, 781 00:32:36,087 --> 00:32:37,522 THERE'S ALSO THE PAIN RESILIENCE 782 00:32:37,522 --> 00:32:39,591 SKILL THAT WE LOOKED AT. WE DO 783 00:32:39,591 --> 00:32:41,927 SEE LOWER LEVELS OF THESE TYPES 784 00:32:41,927 --> 00:32:43,595 OF FACTORS AS WELL BUT, YOU 785 00:32:43,595 --> 00:32:47,833 KNOW, WHEN YOU THINK ABOUT 786 00:32:47,833 --> 00:32:48,400 RESILIENCE YOU CAN KIND OF 787 00:32:48,400 --> 00:32:52,070 CONCEPTUALIZE IT. FROM ACROSS 788 00:32:52,070 --> 00:32:52,971 OTHER BEHAVIORAL FUNCTIONAL 789 00:32:52,971 --> 00:32:56,408 TYPES OF CHARACTERISTICS. SO 790 00:32:56,408 --> 00:32:58,009 PEOPLE WHO GET POOR SLEEP, YOU 791 00:32:58,009 --> 00:33:00,545 KNOW, THAT IS GOING TO 792 00:33:00,545 --> 00:33:01,813 ULTIMATELY HAVE A DETRIMENTAL 793 00:33:01,813 --> 00:33:04,316 IMPACT ON PAIN AND BURDEN. SO 794 00:33:04,316 --> 00:33:08,019 THIS IS AN AREA THAT WE'RE JUST 795 00:33:08,019 --> 00:33:10,388 STARTING TO DIVE INTO. WE HAVE 796 00:33:10,388 --> 00:33:12,257 FOUND THAT OUR CERTAIN KIND OF 797 00:33:12,257 --> 00:33:13,091 PSYCHOLOGICAL RESILIENCE 798 00:33:13,091 --> 00:33:14,626 CHARACTERISTICS THAT ARE 799 00:33:14,626 --> 00:33:15,160 AFFILIATED WITH THE PAIN 800 00:33:15,160 --> 00:33:18,997 EXPERIENCE. SO STAY TUNED. 801 00:33:18,997 --> 00:33:20,599 >> AMAZING, THANK YOU. AND I'LL 802 00:33:20,599 --> 00:33:22,200 NOTE THAT ONE OF OUR AUDIENCE 803 00:33:22,200 --> 00:33:23,735 MEMBERS, ONE OF OUR RESEARCHES 804 00:33:23,735 --> 00:33:25,804 IS NOTING THAT FOR THEIR 805 00:33:25,804 --> 00:33:27,172 SUBPOPULATION THERE WASN'T A 806 00:33:27,172 --> 00:33:29,207 DIFFERENCE BASED ON RACE AND SO 807 00:33:29,207 --> 00:33:30,809 THIS MIGHT DIFFER BASED ON HOW 808 00:33:30,809 --> 00:33:32,978 LARGE YOUR POPULATIONS ARE AND 809 00:33:32,978 --> 00:33:34,613 WHICH EXACT POPULATIONS YOU'RE 810 00:33:34,613 --> 00:33:36,181 LOOKING AT. EVEN MORE SPEAKS TO 811 00:33:36,181 --> 00:33:37,482 YOUR POINT ABOUT REALLY 812 00:33:37,482 --> 00:33:40,819 PERSONALIZING HOW WE THINK ABOUT 813 00:33:40,819 --> 00:33:41,019 THIS. 814 00:33:41,019 --> 00:33:42,520 >> YEAH, ABSOLUTELY, EVERYBODY'S 815 00:33:42,520 --> 00:33:43,288 EXPERIENCE IS QUITE DIFFERENT 816 00:33:43,288 --> 00:33:45,090 FROM ONE ANOTHER. YEP. 817 00:33:45,090 --> 00:33:46,458 >> PERFECT. THANK YOU SO MUCH 818 00:33:46,458 --> 00:33:48,560 DR. BARTLEY. I AM GOING TO ASK 819 00:33:48,560 --> 00:33:49,394 THAT YOU MAYBE CONTINUE TO 820 00:33:49,394 --> 00:33:50,762 ANSWER ANY QUESTIONS THAT POP UP 821 00:33:50,762 --> 00:33:54,266 FOR YOU IN THE Q&A. AND -- BYLY 822 00:33:54,266 --> 00:33:55,767 LET US MOVE ONTO OUR NEXT 823 00:33:55,767 --> 00:33:56,601 SPEAKER, THANK YOU SO MUCH FOR 824 00:33:56,601 --> 00:33:57,936 THAT TALK. 825 00:33:57,936 --> 00:34:01,172 >> YEAH, THANK YOU. 826 00:34:01,172 --> 00:34:07,178 >> SO OUR NEXT SPEAKER IS 827 00:34:07,178 --> 00:34:17,689 DR. JAE AND JUST AS WE TALKED 828 00:34:17,689 --> 00:34:18,957 ABOUT HOW SOME OF THE CURRENT 829 00:34:18,957 --> 00:34:20,825 DRUGS ARE NOT SO HELPFUL AND 830 00:34:20,825 --> 00:34:21,860 THERE'S A LARGE PERCENTAGE OF 831 00:34:21,860 --> 00:34:23,028 THE POPULATION WHO STILL HAVE 832 00:34:23,028 --> 00:34:25,463 PAIN AND STILL HAVE PROBLEMS 833 00:34:25,463 --> 00:34:26,765 AFTERWARDS. THERE IS A LARGE 834 00:34:26,765 --> 00:34:29,200 FOCUS ON DEVELOPING NEW 835 00:34:29,200 --> 00:34:35,473 TREATMENTS FOR ENDO MEE TRIO 836 00:34:35,473 --> 00:34:39,177 SIS. SO THERE'S AN 837 00:34:39,177 --> 00:34:41,713 ANTI-INFLAMMATORY NANO DRUG FOR 838 00:34:41,713 --> 00:34:41,980 TREATMENT. 839 00:34:41,980 --> 00:34:43,415 >> THANK YOU FOR THE NICE 840 00:34:43,415 --> 00:34:45,417 INTRODUCTION. WE ARE PERFORMING 841 00:34:45,417 --> 00:34:53,692 THE NICHD PROGRAM AND WORK WITH 842 00:34:53,692 --> 00:34:56,962 DR. DIANE TO DEVELOP THIS 843 00:34:56,962 --> 00:34:58,630 ANTI-INFLAMMATORY DRUG FOR 844 00:34:58,630 --> 00:34:59,798 ENDOMETRIOSIS. I THINK THE 845 00:34:59,798 --> 00:35:05,470 DOCTOR GAVE A NICE PREVIEW OF 846 00:35:05,470 --> 00:35:10,475 ENDOMETRIOSIS. THIS IS AN 847 00:35:10,475 --> 00:35:13,611 ESTROGEN-DEPENDENT CHRONIC 848 00:35:13,611 --> 00:35:15,213 INFLAMMATORY DISEASE 849 00:35:15,213 --> 00:35:19,517 CHARACTERIZED BY THE PRESENCE OF 850 00:35:19,517 --> 00:35:21,286 ENDOMETRIUM-LIKE TISSUE OUTSIDE 851 00:35:21,286 --> 00:35:25,590 OF THE UTE USE. ONE IN TEN 852 00:35:25,590 --> 00:35:27,025 REPRODUCTIVE AGE WOMAN, 853 00:35:27,025 --> 00:35:28,793 WORLDWIDE ARE SUFFERING. THE 854 00:35:28,793 --> 00:35:30,562 MAJOR SYSTEMS ARE THE CHRONIC 855 00:35:30,562 --> 00:35:33,264 PELVIC PAIN AND THE INFERTILITY. 856 00:35:33,264 --> 00:35:35,567 AND ONE OF THE USES HAVE 857 00:35:35,567 --> 00:35:40,672 INCREASED THE LEVELS OF 858 00:35:40,672 --> 00:35:42,941 PROINFLAMMATORY MEDIATORS IN 859 00:35:42,941 --> 00:35:45,510 PERITONEAL FLUID, AND THE 860 00:35:45,510 --> 00:35:51,216 ECTOPIC LESIONS AND THE UTOPIC 861 00:35:51,216 --> 00:35:52,984 ENDOMETRIUM. AND THE 862 00:35:52,984 --> 00:35:56,654 ANTI-INFLAMMATORY DRUGS ARE 863 00:35:56,654 --> 00:35:58,690 SOMETIMES USED TO REDUCE PAIN. 864 00:35:58,690 --> 00:36:02,027 SO WE ARE INTERESTED TO WHAT 865 00:36:02,027 --> 00:36:05,163 KIND OF MOLECULES ARE INVOLVED 866 00:36:05,163 --> 00:36:09,434 WITH THIS PROCESS. ONE, WE ARE 867 00:36:09,434 --> 00:36:12,670 INTERESTED IN THE SIGNAL 868 00:36:12,670 --> 00:36:14,072 TRANSDUCER AND ACTIVATOR OF THE 869 00:36:14,072 --> 00:36:16,408 TRANSPORTATION THREE. GENERALLY 870 00:36:16,408 --> 00:36:18,276 LOCATED IN THE SITE UNTIL 871 00:36:18,276 --> 00:36:20,345 ACTIVATED BY THE 872 00:36:20,345 --> 00:36:23,181 PHOSPHORYLATION. THERE'S A 873 00:36:23,181 --> 00:36:28,319 VARIETY OF THE CYTOKINES SUCH AS 874 00:36:28,319 --> 00:36:32,590 IL-6, IL-11 AND THE OTHER 875 00:36:32,590 --> 00:36:34,726 ACTIVITY AND IT'S LOCATED TO THE 876 00:36:34,726 --> 00:36:37,929 NUCLEUS AND THEN ACTIVATED 877 00:36:37,929 --> 00:36:41,833 SEVERAL TRANSCRIPTION SO THE 878 00:36:41,833 --> 00:36:45,904 PHOSPHORYLATED STAT3 IS RELATED 879 00:36:45,904 --> 00:36:48,106 TO SEVERAL BIOLOGICAL FACTOR 880 00:36:48,106 --> 00:36:52,177 INCLUDING ANGIOGENESIS, 881 00:36:52,177 --> 00:36:52,844 IMMUNOSUPPRESSION, INFLAMMATION 882 00:36:52,844 --> 00:36:59,117 AND CHRONIC PAIN. AFTER -- 883 00:36:59,117 --> 00:37:00,051 STAT3 ALSO AFFECTS THE 884 00:37:00,051 --> 00:37:01,052 TRANSLATION AND THE EXPRESSION 885 00:37:01,052 --> 00:37:11,596 OF IL-6, IL-1 BETA, TNF-ALPHA, 886 00:37:11,896 --> 00:37:19,804 CCLT AND SOCS 3. FIRSTLY, IF 887 00:37:19,804 --> 00:37:22,807 THERE'S THE DEVELOPMENT IN THE 888 00:37:22,807 --> 00:37:27,512 HUMAN STEM WITH AND WITHOUT 889 00:37:27,512 --> 00:37:27,946 ENDOMETRIOSIS. 890 00:37:27,946 --> 00:37:31,049 AS YOU CAN SEE THE POSTTEST IS A 891 00:37:31,049 --> 00:37:36,221 HIGH IN YOU TOPIC ENDOMETRIUM 892 00:37:36,221 --> 00:37:38,456 FROM COMPARED TO THE CONTROL 893 00:37:38,456 --> 00:37:44,763 WITHOUT ENDO -- ENDOMETRIOSIS XF 894 00:37:44,763 --> 00:37:47,899 AND THEN WE WANT TO LOOK AT THE 895 00:37:47,899 --> 00:37:49,334 ACTIVATION SO THE COLLABORATION 896 00:37:49,334 --> 00:37:51,803 WITH THE DOCTOR ASK US AT THE 897 00:37:51,803 --> 00:37:54,139 MICHIGAN STATE UNIVERSITY. HE 898 00:37:54,139 --> 00:37:57,442 USED -- AND USES NONHUMAN 899 00:37:57,442 --> 00:38:01,279 PRIMATE ENDO MEE 2R50E OWE SIS 900 00:38:01,279 --> 00:38:03,715 MODEL THAT MIMICS THE 901 00:38:03,715 --> 00:38:05,783 ELECTROGRADE TOD. 902 00:38:05,783 --> 00:38:09,921 HE INOCULATE THE TISSUE TO THE 903 00:38:09,921 --> 00:38:11,689 PERRY TEE ANYMORE AND THE ANIMAL 904 00:38:11,689 --> 00:38:19,264 DEVELOPED ENDOMETRIOSIS. BEFORE 905 00:38:19,264 --> 00:38:21,599 ENDO MEE 2R50E OWE SIS 906 00:38:21,599 --> 00:38:23,501 INDUCTION, BUT AFTER INDUCTION, 907 00:38:23,501 --> 00:38:28,640 IT VARIES QUICK. FIRST OF ALLY 908 00:38:28,640 --> 00:38:30,275 INCREASING. WE ALSO USED THE 909 00:38:30,275 --> 00:38:35,847 MOST MODEL FOR ENDO MEE TRIO SIS 910 00:38:35,847 --> 00:38:39,150 STUDY AND THERE'S ACTIVATION OF 911 00:38:39,150 --> 00:38:43,154 THE POST SIGNAL AFTER 912 00:38:43,154 --> 00:38:53,464 ENDOMETRIOSIS INDUCTION SO OUR 913 00:38:53,464 --> 00:38:55,600 HYPOTHESIS IS THIS PLAYS A 914 00:38:55,600 --> 00:38:58,770 CRUCIAL ROLE IN CHRONIC PAIN. 915 00:38:58,770 --> 00:39:03,608 AND POTENTIAL TARGET FIRST IS TO 916 00:39:03,608 --> 00:39:04,943 DOWN REGULATE THE SIGNALLING 917 00:39:04,943 --> 00:39:09,814 PATH WEI USING ANTIOXIDANT DRUG. 918 00:39:09,814 --> 00:39:13,484 TO PROVE THIS HYPOTHESIS WE 919 00:39:13,484 --> 00:39:18,256 DEVELOPED A PRECLINICAL MOUSE 920 00:39:18,256 --> 00:39:25,530 USED IN THIS. AND THIS IS 921 00:39:25,530 --> 00:39:36,074 SIMPLY THE MOUSE. WE HAVE THE 922 00:39:37,242 --> 00:39:41,045 AUTOURINE THAT BECOME LOOSE. SO 923 00:39:41,045 --> 00:39:44,849 IN USING THE BIOLUMINESCENCE IN 924 00:39:44,849 --> 00:39:48,152 IN VIVO IMAGING WE CAN BASICALLY 925 00:39:48,152 --> 00:39:51,589 DETECT THE UTERUS AND WE CAN 926 00:39:51,589 --> 00:39:53,891 MAKE A 3D IMAGE OF THE UTERUS IN 927 00:39:53,891 --> 00:39:58,596 THE LIVE ANIMAL AND ALSO THE -- 928 00:39:58,596 --> 00:40:03,468 IN ADDITION WE CAN USE THE 929 00:40:03,468 --> 00:40:08,506 FLUORESCENCE MICROSCOPIC. 930 00:40:08,506 --> 00:40:11,075 MICROSCOPE. WE CAN LOOK AT THIS 931 00:40:11,075 --> 00:40:13,011 AND ALL OF THESE ARE IN GREEN 932 00:40:13,011 --> 00:40:15,546 COLOR AND OTHER TISSUES ARE THE 933 00:40:15,546 --> 00:40:18,650 LIGHTER COLOR. SO WE APPLY THE 934 00:40:18,650 --> 00:40:21,719 SAME STANDARD SURGICAL INDUCTION 935 00:40:21,719 --> 00:40:28,826 OF AN ENDO MEE TREATISE RELATED 936 00:40:28,826 --> 00:40:35,600 TO THAT. AND INJECT THE TISSUE. 937 00:40:35,600 --> 00:40:42,907 AND THEN THE -- FROM THE MOUSE 938 00:40:42,907 --> 00:40:53,451 ARE SIMILAR TO THE HUMAN SO THE 939 00:40:53,985 --> 00:40:57,789 ADVANTAGE IS THAT WE HAVE THIS 940 00:40:57,789 --> 00:41:01,092 IMAGING. SO WE CAN CAN HAVE A 941 00:41:01,092 --> 00:41:04,028 NONINVASIVE MONITORING OF THE 942 00:41:04,028 --> 00:41:05,096 ENDOMETRIOSIS PROGRESSION IN 943 00:41:05,096 --> 00:41:07,632 LIVE ANIMAL. AFTER WE -- THEY 944 00:41:07,632 --> 00:41:12,570 USE -- WE USE THE GFP REPORTER 945 00:41:12,570 --> 00:41:16,274 SYSTEM. IT'S LIVE VISUALIZATION 946 00:41:16,274 --> 00:41:21,913 OF THE LESIONS. DETECTION IS 947 00:41:21,913 --> 00:41:24,415 SEN SENSITIVE AND VERY FAST AND 948 00:41:24,415 --> 00:41:27,018 IT'S POSSIBLE TO QUANTITATIVE 949 00:41:27,018 --> 00:41:27,652 ANALYSIS. 950 00:41:27,652 --> 00:41:30,922 YOU CAN SEE IT'S THE BRIGHT 951 00:41:30,922 --> 00:41:33,424 FILLED IMAGE. THIS REGION CAN 952 00:41:33,424 --> 00:41:35,893 DETECT A. SMALL ONE IS EVEN 953 00:41:35,893 --> 00:41:39,630 DIFFICULT TO DETECT BUT YOU SEE 954 00:41:39,630 --> 00:41:41,866 THIS FLUORESCENCE WE CAN DETECT 955 00:41:41,866 --> 00:41:46,270 ALL THOSE SMALL ENDOMETRIOSIS 956 00:41:46,270 --> 00:41:48,773 LESION. IF YOU LOOK AT THIS, WE 957 00:41:48,773 --> 00:41:51,876 CAN REMOVE THIS REGION. MINIMAL 958 00:41:51,876 --> 00:41:55,546 IMAGE OF THE NORMAL TISSUE TOO 959 00:41:55,546 --> 00:42:01,486 SO YOU THINK THERE'S A MOUSE 960 00:42:01,486 --> 00:42:04,422 THERE WE CAN HAVE A GOOD PLACE 961 00:42:04,422 --> 00:42:09,360 TO STUDY THE ENDOMETRIOSIS AS 962 00:42:09,360 --> 00:42:12,663 ASSOCIATED IN INFERTILITY AND IN 963 00:42:12,663 --> 00:42:17,201 PAIN. AND ENDOMETRIOSIS IS 964 00:42:17,201 --> 00:42:21,105 BASED ON THE MICE. SO WE HAVE 965 00:42:21,105 --> 00:42:24,275 THE HUMAN. IF WE GIVE THE 966 00:42:24,275 --> 00:42:26,110 ESTROGEN IN THE CONDITION THE 967 00:42:26,110 --> 00:42:28,980 NUMBER IS SIMILAR TO AN INCREASE 968 00:42:28,980 --> 00:42:33,885 COMPARED TO THE CONTROL AND THEN 969 00:42:33,885 --> 00:42:35,853 WE HAVE THIS THAT IS LESS AND 970 00:42:35,853 --> 00:42:37,655 THERE WE CHECK THE MAJOR SYMPTOM 971 00:42:37,655 --> 00:42:39,891 OF THE HUMAN IN OUR ANIMAL 972 00:42:39,891 --> 00:42:44,962 MODEL. PLUS THE SYMPTOM IS THE 973 00:42:44,962 --> 00:42:52,003 INFERTILITY AFTER THE ENDO ME M 974 00:42:52,003 --> 00:42:55,506 TRIO SIS WE CAN LOOK AT THE 975 00:42:55,506 --> 00:43:02,880 ANIMAL WITH ENDSO ONE OF THE 976 00:43:02,880 --> 00:43:07,151 MAJOR FOCUS IS THE 977 00:43:07,151 --> 00:43:07,752 ENDOMETRIOSIS-RELATED PAIN IN 978 00:43:07,752 --> 00:43:10,755 OUR ANIMAL MODEL. ENDOMETRIOSIS 979 00:43:10,755 --> 00:43:12,356 IS A CHRONICEN FLAME STORY 980 00:43:12,356 --> 00:43:13,691 CONDITION THAT CAUSES PAIN IN 981 00:43:13,691 --> 00:43:17,528 THE PELVIS, ESPECIALLY DURING 982 00:43:17,528 --> 00:43:28,072 MENSTRUAL PERIOD. THE LACK OF 983 00:43:28,673 --> 00:43:29,941 PHARMACOLOGICAL TREATMENTS 984 00:43:29,941 --> 00:43:31,843 SUITABLE FOR THE LONG-TERM 985 00:43:31,843 --> 00:43:34,946 RELIEF OF 986 00:43:34,946 --> 00:43:35,780 ENDOMETRIOSIS-ASSOCIATED PAIN 987 00:43:35,780 --> 00:43:40,051 WITHOUT AN IMPACT OF FERTILITY. 988 00:43:40,051 --> 00:43:41,786 PROGRESS HAS BEEN SLOWED BY THE 989 00:43:41,786 --> 00:43:44,589 ABSENCE OF A REPRODUCIBLE ENDO 990 00:43:44,589 --> 00:43:47,625 MEE THREE AGREE SIS MODEL THAT 991 00:43:47,625 --> 00:43:48,459 FULLY REPLICATES HUMAN PATH SIZ 992 00:43:48,459 --> 00:43:50,261 OWE LOGICAL CHARACTERISTICS 993 00:43:50,261 --> 00:43:52,296 INCLUDING PAIN SYMPTOMS PAIN IS 994 00:43:52,296 --> 00:43:54,165 USUALLY MEASURED TO WITH FLEX 995 00:43:54,165 --> 00:43:56,501 AND NON REFLEX TESTING IN ANIMAL 996 00:43:56,501 --> 00:43:58,503 MODEL THE REFLEX -- FOR THE 997 00:43:58,503 --> 00:44:02,440 REFLEX TEST, A HYPERSENSITIVITY 998 00:44:02,440 --> 00:44:06,944 IS EVALUATED BY APPLYING A 999 00:44:06,944 --> 00:44:08,479 NOXIOUS STIMULUS BUT THIS 1000 00:44:08,479 --> 00:44:12,550 IGNORES THE ASSOCIATED EMOTIONAL 1001 00:44:12,550 --> 00:44:15,786 COMPONENT. WE USE THE NON 1002 00:44:15,786 --> 00:44:18,623 REFLEX TEST STUDY AND NON REFLEX 1003 00:44:18,623 --> 00:44:23,027 TEST INCLUDING THE BURROWING 1004 00:44:23,027 --> 00:44:27,532 TEST, MARBLE BURRING TEST AND 1005 00:44:27,532 --> 00:44:37,775 NESTING TEST. FOR THE BURROWING 1006 00:44:37,775 --> 00:44:41,145 TEST. THE MOUSE DILIGENTLY 1007 00:44:41,145 --> 00:44:42,747 TRIED TO TAKE OUT THE FOOD 1008 00:44:42,747 --> 00:44:47,318 OUTSIDE THE SICYLINDER. YOU CA 1009 00:44:47,318 --> 00:44:51,455 SAY THEY TAKE UP ALMOST ALL THE 1010 00:44:51,455 --> 00:44:53,124 PELLET. HOWEVER IN THE MOUSE 1011 00:44:53,124 --> 00:44:56,494 WITH THE ENDOMETRIOSIS, THE 1012 00:44:56,494 --> 00:45:01,098 WEIGHT BURROWED IS SNARNT 1013 00:45:01,098 --> 00:45:03,935 SIGNIFICANTLY REDUCED COMPARED. 1014 00:45:03,935 --> 00:45:07,572 THE SECOND TEST IS THE MARBLE 1015 00:45:07,572 --> 00:45:09,173 TEST WE PUT SEVERAL MARBLES IN 1016 00:45:09,173 --> 00:45:10,007 THE CAGE. 1017 00:45:10,007 --> 00:45:12,209 THEY TRY TO HIDE ALL THE MARBLES 1018 00:45:12,209 --> 00:45:15,713 INSIDE THE BEDDING. SO YOU CAN 1019 00:45:15,713 --> 00:45:18,049 SEE THIS AND THEN IF THEY HIDE 1020 00:45:18,049 --> 00:45:19,850 THE MARBLE COMPLETELY WE GIVE 1021 00:45:19,850 --> 00:45:23,087 THE HIGH SCORE. IF THEY DO NOT 1022 00:45:23,087 --> 00:45:25,590 TOUCH THE MARBLE WE GIVE THE 1023 00:45:25,590 --> 00:45:27,892 OTHER SCORE AND YOU CAN SEE IN 1024 00:45:27,892 --> 00:45:30,394 SHAM YOU SEE THE ORIGINAL NUMBER 1025 00:45:30,394 --> 00:45:32,730 AROUND NINE. BUT IN THE MOUSE 1026 00:45:32,730 --> 00:45:36,400 WITH THE ENDO THREE TRIO SIS THE 1027 00:45:36,400 --> 00:45:37,001 MARBLE SCORE IS SIGNIFICANTLY 1028 00:45:37,001 --> 00:45:42,273 REDUCED. AND LAST TEST IS THAT 1029 00:45:42,273 --> 00:45:46,110 NESTING TEST. FOR THE SMALLER 1030 00:45:46,110 --> 00:45:49,180 THEM, THE LAST IMPORTANT THING 1031 00:45:49,180 --> 00:45:55,186 HIT AS IN THE PRODUCTION. SO IF 1032 00:45:55,186 --> 00:45:58,623 YOU PUT THE NAP THAT THEY 1033 00:45:58,623 --> 00:46:00,791 GENERALLY MAKE. IF EACH 1034 00:46:00,791 --> 00:46:02,893 COMPLETE NESTING WE GIVE A SCORE 1035 00:46:02,893 --> 00:46:05,162 FIVE. IF IT'S INCOMPLETE WE 1036 00:46:05,162 --> 00:46:07,131 GIVE LOW SCORE IN THE SHAM 1037 00:46:07,131 --> 00:46:10,134 THOUGH YOU CAN SEE THE MOUSE 1038 00:46:10,134 --> 00:46:15,039 MAKE THIS. BUT MICE WITH ENDIS 1039 00:46:15,039 --> 00:46:18,509 LASTING SCORE IS A SIGNIFICANTLY 1040 00:46:18,509 --> 00:46:29,053 REDUCED SO THIS IS AN ENDO MEE 1041 00:46:29,687 --> 00:46:30,254 THREE I DIDN'T SAY AND THIS IS 1042 00:46:30,254 --> 00:46:36,060 RELATED TO THE PAIN. 1043 00:46:36,060 --> 00:46:36,360 A 1044 00:46:36,360 --> 00:46:38,295 IT HAS THE AND TO IF A SIT 1045 00:46:38,295 --> 00:46:42,333 ANYBODY. I MENTIONED THAT 1046 00:46:42,333 --> 00:46:45,069 THERE'S THIS. AND THIS IS 1047 00:46:45,069 --> 00:46:49,173 APPROVED WITH THE ELASTICITY FOR 1048 00:46:49,173 --> 00:46:59,717 THE ARTHRITIS. SO THIS YOU CAN 1049 00:47:00,451 --> 00:47:05,956 SEE THIS REDUCED THE LESION. 1050 00:47:05,956 --> 00:47:10,328 AND WE APPLY THE SAME IN OUR 1051 00:47:10,328 --> 00:47:15,299 ANIMAL MODEL. WE HAVE THE SAME 1052 00:47:15,299 --> 00:47:18,302 ORIGINAL TOOL. TO IF AS SIT 1053 00:47:18,302 --> 00:47:20,738 ANYBODY SHOWED REDUCTION IN 1054 00:47:20,738 --> 00:47:24,508 ENDOMETRIOSIS DEVELOPMENT. 1055 00:47:24,508 --> 00:47:26,377 HOWEVER THE PROBLEM OF SEVERAL 1056 00:47:26,377 --> 00:47:28,179 IS THE SYSTEM INSIDE THE FACTOR 1057 00:47:28,179 --> 00:47:32,450 SO WHAT -- FROM THAT, IT'S 1058 00:47:32,450 --> 00:47:33,918 KNOWING THE STAT IS IMPORTANT 1059 00:47:33,918 --> 00:47:35,286 FOR THE FUNCTION. ESPECIALLY 1060 00:47:35,286 --> 00:47:38,022 FOR ALL THE PREGNANCY. FROM THAT 1061 00:47:38,022 --> 00:47:38,656 IS IMPORTANT FOR THE FUNCTION. 1062 00:47:38,656 --> 00:47:39,156 ESPECIALLY FOR ALL THE 1063 00:47:39,156 --> 00:47:41,359 PREGNANCY. WHEN WE APPLY THE 1064 00:47:41,359 --> 00:47:43,060 THE TOFACITINIB INHIBITOR WE CAN 1065 00:47:43,060 --> 00:47:46,130 SEE THE IMPLANTATION IMPACTS. 1066 00:47:46,130 --> 00:47:47,998 IN THE VEHICLE YOU CAN SEE THE 1067 00:47:47,998 --> 00:47:53,404 NICE IMPLEMENTATION BUT THIS 1068 00:47:53,404 --> 00:47:56,440 INDIVIDUAL WITH THE TO IF A SIS 1069 00:47:56,440 --> 00:48:01,879 ANYBODY SHOWS A FAILURE. 1070 00:48:01,879 --> 00:48:04,415 BUT THIS WAS DUE TO THE SYSTEM, 1071 00:48:04,415 --> 00:48:06,350 MAYBE DUE TO THE SYSTEMIC 1072 00:48:06,350 --> 00:48:09,754 PRACTICE SO WE COLLABORATE. WE 1073 00:48:09,754 --> 00:48:15,292 DID THIS AT THE UNIVERSITY OF 1074 00:48:15,292 --> 00:48:17,394 MICHIGAN STATE UNIVERSITY. WE 1075 00:48:17,394 --> 00:48:20,197 APPLY A NANO PARTICLE EXPERT TO 1076 00:48:20,197 --> 00:48:21,832 PRODUCE A SYSTEMIC EFFECT FOR 1077 00:48:21,832 --> 00:48:25,903 TREATMENT OF THE ENDOMETRIOSIS. 1078 00:48:25,903 --> 00:48:33,778 NANO PARTICLE IS THE SMALL 1-100 1079 00:48:33,778 --> 00:48:34,979 NANO MOLECULE AND HAS A FUNCTION 1080 00:48:34,979 --> 00:48:41,152 OF THE PROPERTY AND PRODUCED THE 1081 00:48:41,152 --> 00:48:43,220 TARGETING TOXICITY AND CAN HAVE 1082 00:48:43,220 --> 00:48:47,825 THE THEY ARE RAH NOVEMBERSIC 1083 00:48:47,825 --> 00:48:48,125 PLASTICITY. 1084 00:48:48,125 --> 00:48:51,695 SO WHAT ARE WE PUTTING IN THIS 1085 00:48:51,695 --> 00:48:54,231 SIN NAP RATE TO THE TISSUE BUT 1086 00:48:54,231 --> 00:49:00,271 IT'S PENETRATED DUE TO THE 1087 00:49:00,271 --> 00:49:02,573 ANGIOGENIC ACCUMULATED TO THE 1088 00:49:02,573 --> 00:49:05,342 REGION. SO THE -- HERE APPLIED 1089 00:49:05,342 --> 00:49:09,246 THE THEY ARE RAN NOVEMBERSIC 1090 00:49:09,246 --> 00:49:11,448 NANO SYRIA HAS THE IMPACT AS 1091 00:49:11,448 --> 00:49:15,486 WELL AS NONINVASIVE IMAGING. SO 1092 00:49:15,486 --> 00:49:18,022 IF YOU GENERATED THIS HERE, 1093 00:49:18,022 --> 00:49:21,458 APPLIED THIS NAN PARTICLE TO 1094 00:49:21,458 --> 00:49:24,995 THIS AND HAVE THIS SWITCHING 1095 00:49:24,995 --> 00:49:28,466 MACROPHAGE FROM THE M 1 1096 00:49:28,466 --> 00:49:31,202 PROINFLAMMATORY AND TO THE OTHER 1097 00:49:31,202 --> 00:49:33,904 INFLAMMATORY STAGE AND ALSO POST 1098 00:49:33,904 --> 00:49:36,273 MRAS 'TIS SI LEVEL HAS DECRE 1099 00:49:36,273 --> 00:49:36,574 DECREASED. 1100 00:49:36,574 --> 00:49:40,044 WE CHECK THE TARGET AND WITH THE 1101 00:49:40,044 --> 00:49:43,914 DIAGNOSIS USING THE IMAGING. 1102 00:49:43,914 --> 00:49:46,417 THE DELIVERY FACTOR YOU CAN SEE 1103 00:49:46,417 --> 00:49:50,855 THE DRUG IS ACCUMULATED FOR ONLY 1104 00:49:50,855 --> 00:49:53,424 THE ECTOPIC LESION BUT NOT IN 1105 00:49:53,424 --> 00:49:57,728 THE UTOPIC. HOWEVER, IF THIS IS 1106 00:49:57,728 --> 00:50:00,664 NOT HARMFUL, SO NANO SYRIA, NOT 1107 00:50:00,664 --> 00:50:07,504 HALF OF THE IMPLEMENTATION AND 1108 00:50:07,504 --> 00:50:10,241 WE CHECK THE EFFECTIVENESS OF 1109 00:50:10,241 --> 00:50:16,213 THIS ENDO MEE TRIO SIS. AND WE 1110 00:50:16,213 --> 00:50:19,183 HAVE THE REGION USING THE 1111 00:50:19,183 --> 00:50:19,450 IMAGING. 1112 00:50:19,450 --> 00:50:23,053 AND AN ALSO LASTLY WE SHOULD 1113 00:50:23,053 --> 00:50:25,389 CHECK THE NANO SYRIA THAT 1114 00:50:25,389 --> 00:50:28,325 REDUCES THE NUMBER OF ECTOPIC 1115 00:50:28,325 --> 00:50:31,395 SITE COMPARED TO THE VEHICLE. 1116 00:50:31,395 --> 00:50:33,430 SON ALSO LASTLY WE SHOULD 1117 00:50:33,430 --> 00:50:33,964 CHECK THE NANO SYRIA THAT 1118 00:50:33,964 --> 00:50:34,565 REDUCES THE NUMBER OF ECTOPIC 1119 00:50:34,565 --> 00:50:35,199 SITE COMPARED TO THE VEHICLE. 1120 00:50:35,199 --> 00:50:35,900 ALSO LASTLY WE SHOULD CHECK 1121 00:50:35,900 --> 00:50:36,533 THE NANO SYRIA THAT REDUCES THE 1122 00:50:36,533 --> 00:50:37,167 NUMBER OF ECTOPIC SITE COMPARED 1123 00:50:37,167 --> 00:50:38,736 TO THE VEHICLALSO LASTLY WE SHO 1124 00:50:38,736 --> 00:50:39,370 THE NANO SYRIA THAT REDUCES THE 1125 00:50:39,370 --> 00:50:40,004 NUMBER OF ECTOPIC SITE COMPARED 1126 00:50:40,004 --> 00:50:40,638 TO THE VEHICLE. SO THE DATA 1127 00:50:40,638 --> 00:50:45,910 SHOWS THE ESTROGEN DEPENDENT 1128 00:50:45,910 --> 00:50:47,144 INFLAMMATION. THEY ARE 1129 00:50:47,144 --> 00:50:49,780 NOVEMBERSIC NANO SYRIA, A NOVEL 1130 00:50:49,780 --> 00:50:51,615 ANTIUP FLAMMATORY NAN PART KM 1131 00:50:51,615 --> 00:50:52,549 PROVIDES A PROMISING APPROACH 1132 00:50:52,549 --> 00:50:55,986 FOR ENDOMETRIOSIS TREATMENT. 1133 00:50:55,986 --> 00:50:58,589 NOW WE HAVE THIS ASSOCIATED WITH 1134 00:50:58,589 --> 00:51:01,025 PAIN. I WILL THANK YOU FOR OUR 1135 00:51:01,025 --> 00:51:05,496 MEMBERS, ALSO OUR COLLABORATOR, 1136 00:51:05,496 --> 00:51:10,501 DR. KIM AND NIHCD FUNDING. 1137 00:51:10,501 --> 00:51:12,036 OKAY, I STOP HERE. I'M HAPPY TO 1138 00:51:12,036 --> 00:51:15,973 TAKE QUESTIONS. 1139 00:51:15,973 --> 00:51:19,209 >> THANK YOU. THAT WAS A 1140 00:51:19,209 --> 00:51:20,577 FANTASTIC AMAZING FIFTEEN MINUTE 1141 00:51:20,577 --> 00:51:22,646 FORAY INTO THIS. MUCH OF OUR 1142 00:51:22,646 --> 00:51:24,548 AUDIENCE TODAY ARE NOT 1143 00:51:24,548 --> 00:51:25,616 RESEARCHERS BY TRAINING AND ARE 1144 00:51:25,616 --> 00:51:27,518 THE LAY PUBLIC SO I THINK BEING 1145 00:51:27,518 --> 00:51:29,186 ABLE TO SHOW THEM HOW WE CAN USE 1146 00:51:29,186 --> 00:51:31,455 A MOUSE MODEL AND ACTUALLY HAVE 1147 00:51:31,455 --> 00:51:35,192 THAT MOUSE MODEL LOOK LIKE IT 1148 00:51:35,192 --> 00:51:36,860 HAS ENDOMETRIOSIS AND LOOK AT 1149 00:51:36,860 --> 00:51:38,829 THE BEHAVIOR OF THESE MICE TO 1150 00:51:38,829 --> 00:51:39,496 DETECT WHAT LEVEL OF PAIN THEY 1151 00:51:39,496 --> 00:51:40,998 HAVE IS REALLY, REALLY 1152 00:51:40,998 --> 00:51:43,968 INTERESTING. BECAUSE I KNOW A 1153 00:51:43,968 --> 00:51:48,672 LOT OF OUR FOLKS WILL ASK HOW DO 1154 00:51:48,672 --> 00:51:50,908 YOU ASK HOW MUCH PAIN A MOUSE 1155 00:51:50,908 --> 00:51:56,914 HAS SO I THINK YOU SHOWING THE 1156 00:51:56,914 --> 00:51:57,381 BEHAVIORAL TEST. 1157 00:51:57,381 --> 00:51:59,616 >> I KNOW WE DON'T HAVE MUCH 1158 00:51:59,616 --> 00:52:01,952 MODEL ABOUT ENDO MEE 2R50E OWE 1159 00:52:01,952 --> 00:52:03,687 SIS ASSOCIATED PAIN. 1160 00:52:03,687 --> 00:52:07,224 SO THAT'S WHY IT'S DIFFICULT TO 1161 00:52:07,224 --> 00:52:09,626 DEVELOP THIS MODEL AND WE HAD 1162 00:52:09,626 --> 00:52:13,063 THE TEST AT SEVERAL DIFFERENT 1163 00:52:13,063 --> 00:52:19,770 METHOD. WE FINALLY FIND THE 1164 00:52:19,770 --> 00:52:21,905 MODEL. IT'S A MOUSE, IT'S 1165 00:52:21,905 --> 00:52:24,575 SIMPLE AND A HOMOGENEOUS ANIMAL 1166 00:52:24,575 --> 00:52:26,510 MODEL. EVEN WE GIVE IT USING 1167 00:52:26,510 --> 00:52:29,880 THE SAME AMOUNT, AT THE SAME 1168 00:52:29,880 --> 00:52:36,120 TIME, THAT -- THE IMPACT ARE. 1169 00:52:36,120 --> 00:52:36,387 DIFFICULT. 1170 00:52:36,387 --> 00:52:39,156 >> THERE'S INDIVIDUALISM. 1171 00:52:39,156 --> 00:52:46,630 >> THAT MEAN IT SHOULD NOT -- WE 1172 00:52:46,630 --> 00:52:49,066 DEVELOPED A MODEL BUT IT'S MORE 1173 00:52:49,066 --> 00:52:49,366 COMPLICATED. 1174 00:52:49,366 --> 00:52:50,367 >> RIGHT. RIGHT. 1175 00:52:50,367 --> 00:52:53,604 >> THAT'S WHY WE WANT TO MONITOR 1176 00:52:53,604 --> 00:52:56,507 THE VISION IN THE LIVE ANIMAL 1177 00:52:56,507 --> 00:53:00,844 AND THEN CHECK THE BEHAVIOR AND 1178 00:53:00,844 --> 00:53:02,479 LOOK AT THE CORRELATION. 1179 00:53:02,479 --> 00:53:06,650 >> YEAH. I MEAN, I THOUGHT -- 1180 00:53:06,650 --> 00:53:07,584 THE PHENOMENAL POTENTIAL OF YOUR 1181 00:53:07,584 --> 00:53:10,254 WORK IS NOT ONLY A THERAPEUTIC 1182 00:53:10,254 --> 00:53:12,756 BUT THE DIAGNOSTIC POTENTIAL IS 1183 00:53:12,756 --> 00:53:14,024 INCREDIBLE WE'VE TALKED ABOUT 1184 00:53:14,024 --> 00:53:17,194 THIS TEN YEAR WE DELAY THE IDEA 1185 00:53:17,194 --> 00:53:19,730 THAT YOU CAN GO IN WITH AN 1186 00:53:19,730 --> 00:53:23,200 IMAGING AND SEE ENDOMETRIOSIS 1187 00:53:23,200 --> 00:53:24,835 LESIONS WOULD BE A GAME CHANGER 1188 00:53:24,835 --> 00:53:25,602 FOR DIAGNOSIS AND THAT'S 1189 00:53:25,602 --> 00:53:27,204 SOMETHING THAT YOU'RE WORKING 1190 00:53:27,204 --> 00:53:27,438 TOWARDS. 1191 00:53:27,438 --> 00:53:29,339 >> YES, THAT IS ONE OF THE 1192 00:53:29,339 --> 00:53:33,077 ADVANTAGE OF THE NANO PARTICLE. 1193 00:53:33,077 --> 00:53:35,012 THAT IS DOCTOR IS AN EXPERT FOR 1194 00:53:35,012 --> 00:53:39,516 THAT. IT'S WHERE APPLIED TO THE 1195 00:53:39,516 --> 00:53:43,787 FIELD. BUT IN OUR FIELD WE ARE 1196 00:53:43,787 --> 00:53:45,823 ONLY A FEW SCIENTISTS THAT THINK 1197 00:53:45,823 --> 00:53:50,661 ABOUT THAT CASE. I THINK -- AND 1198 00:53:50,661 --> 00:53:51,829 ENDOMETRIOSIS, YOU MENTIONED 1199 00:53:51,829 --> 00:53:52,563 IT'S BIOLOGIC. THERE ARE 1200 00:53:52,563 --> 00:53:54,465 SEVERAL IMAGING TOOLS. AND WE 1201 00:53:54,465 --> 00:54:04,241 DON'T HAVE THAT KIND OF POWER. 1202 00:54:04,241 --> 00:54:05,809 >> THE CANCER FIELD HAS 1203 00:54:05,809 --> 00:54:07,244 DEVELOPED THESE TOOLS BUT REALLY 1204 00:54:07,244 --> 00:54:09,546 THE LESIONS ARE VERY MUCH 1205 00:54:09,546 --> 00:54:11,548 CERTAIN KIND OF -- THEY BEHAVE 1206 00:54:11,548 --> 00:54:14,084 IN CERTAIN KINDS OF CONCERN. 1207 00:54:14,084 --> 00:54:16,920 THEY CAN METASTASIZE INTO 1208 00:54:16,920 --> 00:54:18,822 THINGS. OBVIOUSLY THEY ARE NOT 1209 00:54:18,822 --> 00:54:21,825 CANCEROUS BUT THEY CAN SOMETHING 1210 00:54:21,825 --> 00:54:22,459 THAT CAN BE UTILIZED IN THE SAME 1211 00:54:22,459 --> 00:54:24,328 SKILLS AND THE SAME TOOLS THAT 1212 00:54:24,328 --> 00:54:27,097 WE USE FOR CANCER BIOLOGY. 1213 00:54:27,097 --> 00:54:28,732 PHENOMENAL THAT YOU GUYS ARE 1214 00:54:28,732 --> 00:54:29,600 WORKING WITH THAT. 1215 00:54:29,600 --> 00:54:31,635 >> THAT'S WHAT WE ALWAYS SAY 1216 00:54:31,635 --> 00:54:40,244 IT'S UNDERSTUDIED, THE FIELD. 1217 00:54:40,244 --> 00:54:45,182 THER 1218 00:54:45,182 --> 00:54:45,415 THERE'S. 1219 00:54:45,415 --> 00:54:46,316 >> I THINK ASSIST ALL WE HAVE 1220 00:54:46,316 --> 00:54:48,085 TIME FOR BUT I KNOW WE WILL WANT 1221 00:54:48,085 --> 00:54:50,187 YOU TO COME BACK AS YOU HAVE 1222 00:54:50,187 --> 00:54:52,122 UPDATES BUT I AM SURE THAT 1223 00:54:52,122 --> 00:54:53,624 PEOPLE THAT ARE ENDOMETRIOSIS 1224 00:54:53,624 --> 00:54:55,292 AND ARE THINKING ABOUT SOME OF 1225 00:54:55,292 --> 00:54:57,861 THESE THERAPEUTICS WOULD LOVE TO 1226 00:54:57,861 --> 00:54:58,762 SEE SOME OF YOUR WORK HELP THE 1227 00:54:58,762 --> 00:55:06,170 WOMEN IN OUR AUDIENCE. WE WILL 1228 00:55:06,170 --> 00:55:08,639 NOW MOVE ONTO DR. LAURA PAYNE 1229 00:55:08,639 --> 00:55:11,408 WHO IS AN ASSISTANT PROFESSOR AT 1230 00:55:11,408 --> 00:55:12,676 HARVARD MEDICAL SCHOOL. SHE IS 1231 00:55:12,676 --> 00:55:14,311 ALSO THE DIRECTOR OF CLINICAL 1232 00:55:14,311 --> 00:55:16,213 AND TRANSLATIONAL PAIN RESEARCH 1233 00:55:16,213 --> 00:55:18,482 LAB. AT MCQUEEN HOSPITAL. AND 1234 00:55:18,482 --> 00:55:22,653 SHE'S GOING TO TALK TO US TODAY 1235 00:55:22,653 --> 00:55:33,197 ABOUT HOW MENSTRUAL PAIN BECOMES 1236 00:55:35,232 --> 00:55:37,134 CHRONIC PAIN. TAKE IT AWAY 1237 00:55:37,134 --> 00:55:38,101 DR. PAYNE. 1238 00:55:38,101 --> 00:55:40,437 >> YES, YOU WILL HEAR A LITTLE 1239 00:55:40,437 --> 00:55:42,639 BIT MORE ABOUT CENTRAL 1240 00:55:42,639 --> 00:55:43,307 SENSITIZATION FOR SURE ALTHOUGH 1241 00:55:43,307 --> 00:55:45,542 I'M GOING TO BE TALKING ABOUT A 1242 00:55:45,542 --> 00:55:48,779 DIFFERENT TYPE OF MENSTRUAL 1243 00:55:48,779 --> 00:55:51,114 PAIN. THAN ENDOMETRIOSIS 1244 00:55:51,114 --> 00:55:53,917 ASSOCIATED MENSTRUAL PAIN I WILL 1245 00:55:53,917 --> 00:55:56,820 SPEAK PRIMARILY ABOUT PRIMARY 1246 00:55:56,820 --> 00:55:58,355 DYSMENORRHEA AND THIS IS WITHOUT 1247 00:55:58,355 --> 00:56:00,090 ANY IDENTIFIED TISSUE PATHOLOGY. 1248 00:56:00,090 --> 00:56:01,124 SO IT'S A LITTLE BIT DIFFERENT 1249 00:56:01,124 --> 00:56:05,229 BUT CERTAINLY A LOT OF 1250 00:56:05,229 --> 00:56:09,900 SIMILARITIES. JUST A FEW 1251 00:56:09,900 --> 00:56:12,169 DISCLOSURES. SO MEN STRIEL 1252 00:56:12,169 --> 00:56:13,870 PAIN, WE GOT TO TALK ABOUT IT AS 1253 00:56:13,870 --> 00:56:16,173 IT WAS ELUDED TO EARLIER WE 1254 00:56:16,173 --> 00:56:17,741 DON'T TALK ENOUGH ABOUT PAIN 1255 00:56:17,741 --> 00:56:21,044 THAT GIRLS AND WOMEN EXPERIENCE. 1256 00:56:21,044 --> 00:56:25,382 IN PARTICULARLY MENSTRUAL PAIN. 1257 00:56:25,382 --> 00:56:26,617 MENSTRUAL PAIN IS A SIGNIFICANT 1258 00:56:26,617 --> 00:56:28,952 ISSUE FOR MANY REPRODUCTIVE AGE 1259 00:56:28,952 --> 00:56:30,654 GIRLS AND WOMEN IT AFFECTS UP TO 1260 00:56:30,654 --> 00:56:32,689 90% OF GIRLS AND WOMEN. AND 1261 00:56:32,689 --> 00:56:36,226 THIS IS A HUGE PART OF THE 1262 00:56:36,226 --> 00:56:40,297 POPULATION. AND 20-25% OF THIS 1263 00:56:40,297 --> 00:56:42,699 POPULATION EXPERIENCES SEVERE 1264 00:56:42,699 --> 00:56:44,935 AND DISABLING SYMPTOMS AND WHAT 1265 00:56:44,935 --> 00:56:47,170 THAT MEANS IS THAT CYCLE TO 1266 00:56:47,170 --> 00:56:49,239 CYCLE, WHICH IS ON AVERAGE EVERY 1267 00:56:49,239 --> 00:56:50,774 MONTH, THERE'S SIGNIFICANT 1268 00:56:50,774 --> 00:56:53,043 IMPAIRMENT IN DAILY ACTIVITIES 1269 00:56:53,043 --> 00:56:54,711 AND FUNCTIONING. IN PARTICULAR, 1270 00:56:54,711 --> 00:56:57,381 THIS IS IMPORTANT FOR 1271 00:56:57,381 --> 00:56:58,815 ADOLESCENTS. MORE RESEARCH HAS 1272 00:56:58,815 --> 00:57:02,619 REALLY LOOKED AT THE IMPACT OF 1273 00:57:02,619 --> 00:57:05,088 MENSTRUAL PAIN IN ADOLESCENT 1274 00:57:05,088 --> 00:57:06,423 POPULATIONS AND FOUND THAT 1275 00:57:06,423 --> 00:57:08,959 MENSTRUAL PAIN RESULTS IN 1276 00:57:08,959 --> 00:57:11,094 MISSING SCHOOL. IN MISSING 1277 00:57:11,094 --> 00:57:13,230 IMPORTANT ACTIVITIES INCLUDING 1278 00:57:13,230 --> 00:57:16,033 SPORTS, SOCIAL ACTIVITIES, 1279 00:57:16,033 --> 00:57:16,867 INTERFERING WITH DAILY 1280 00:57:16,867 --> 00:57:19,236 FUNCTIONING AND EVEN WHEN GIRLS 1281 00:57:19,236 --> 00:57:21,071 ARE ABLE TO GO TO SCHOOL, IT HAS 1282 00:57:21,071 --> 00:57:23,774 AN IMPACT ON THEIR ABILITY TO 1283 00:57:23,774 --> 00:57:25,409 CONCENTRATE AND FUNCTION IN 1284 00:57:25,409 --> 00:57:27,477 CLASS. SO IT'S A HUGE AND 1285 00:57:27,477 --> 00:57:29,413 SIGNIFICANT PUBLIC HEALTH ISSUE. 1286 00:57:29,413 --> 00:57:31,248 BUT HASN'T RECEIVED ENOUGH 1287 00:57:31,248 --> 00:57:35,385 ATTENTION AND ENOUGH RESEARCH. 1288 00:57:35,385 --> 00:57:37,688 BUT IF THIS ISN'T ALL CONCERNING 1289 00:57:37,688 --> 00:57:41,458 ENOUGH WE ALL KNOW THAT 1290 00:57:41,458 --> 00:57:42,526 MENSTRUAL PAIN IS A RISK FACTOR 1291 00:57:42,526 --> 00:57:45,896 FOR CHRONIC PAIN. THE MANY 1292 00:57:45,896 --> 00:57:46,496 CROSS-SECTIONAL STUDIES HAVE 1293 00:57:46,496 --> 00:57:49,132 SHOWN A STRONG POSITIVE 1294 00:57:49,132 --> 00:57:50,634 ASSOCIATED BETWEEN MENSTRUAL 1295 00:57:50,634 --> 00:57:52,569 PAIN AND CHRONIC PAIN A 1296 00:57:52,569 --> 00:57:54,705 WONDERFUL REVIEW AND 1297 00:57:54,705 --> 00:57:56,606 META-ANALYSIS BY DR. LEE AND 1298 00:57:56,606 --> 00:58:00,043 LESION IN 2020 SHOW THAT HAD 1299 00:58:00,043 --> 00:58:01,478 DYSMENORRHEA FOR MENSTRUAL PAIN 1300 00:58:01,478 --> 00:58:04,381 WAS ASSOCIATED WITH 2.5 TIMES 1301 00:58:04,381 --> 00:58:06,216 THE ODDS OF HAVING A CHRONIC 1302 00:58:06,216 --> 00:58:06,850 PAIN CONDITION. 1303 00:58:06,850 --> 00:58:07,918 SO DEFINITELY A STRONG 1304 00:58:07,918 --> 00:58:11,221 RELATIONSHIP THERE. BUT WE'VE 1305 00:58:11,221 --> 00:58:14,024 NEEDED TO LOOK MORE TEMPORALLY 1306 00:58:14,024 --> 00:58:17,160 TO SEE WHAT IS THIS DEVELOPMENT 1307 00:58:17,160 --> 00:58:18,395 OF CHRONIC PAIN LOOK LIKE IN 1308 00:58:18,395 --> 00:58:19,730 THIS POPULATION AND THERE'S BEEN 1309 00:58:19,730 --> 00:58:21,431 A NUMBER OF STUDIES IN ADULTS 1310 00:58:21,431 --> 00:58:25,035 THAT HAVE TRIED TO LOOK AT THIS. 1311 00:58:25,035 --> 00:58:29,339 SO HARDY AND COLLEAGUES 1312 00:58:29,339 --> 00:58:30,774 PUBLISHED A PAPER FROM A SAMPLE 1313 00:58:30,774 --> 00:58:33,510 OF 100 ADULT WOMEN WHO ARE 1314 00:58:33,510 --> 00:58:34,478 PRESENTING FOR CHRONIC PELVIC 1315 00:58:34,478 --> 00:58:38,382 PAIN AND THEY ASKED THEM 1316 00:58:38,382 --> 00:58:39,750 RETROSPECTIVELY DID YOU HAVE 1317 00:58:39,750 --> 00:58:42,919 MENSTRUAL PAIN AS A TEENAGER AND 1318 00:58:42,919 --> 00:58:45,322 WHEN DID THE PAIN DEVELOP AND 1319 00:58:45,322 --> 00:58:47,624 YOUR CHRONIC PAIN DEVELOP? AND 1320 00:58:47,624 --> 00:58:53,897 100% OF THESE WOMEN 45D HAD 1321 00:58:53,897 --> 00:58:56,333 MENSTRUAL PAIN AS YOUNG GIRLS. 1322 00:58:56,333 --> 00:58:59,269 FOR OVER HALF THE SAMPLE THIS 1323 00:58:59,269 --> 00:59:01,037 TRANSITION HAPPENED IN TWELVE 1324 00:59:01,037 --> 00:59:02,873 YEARS WHICH IS A RELATIVELY 1325 00:59:02,873 --> 00:59:05,242 SHORT TIME. IF YOU THINK ABOUT 1326 00:59:05,242 --> 00:59:07,177 IT, TWELVE YEARS IS REALLY ONLY 1327 00:59:07,177 --> 00:59:09,813 INTO THE MID-20S SO CERTAINLY A 1328 00:59:09,813 --> 00:59:12,983 CONCERNING TIME FOR THAT 1329 00:59:12,983 --> 00:59:16,286 TRANSITI 1330 00:59:16,286 --> 00:59:19,890 TRANSITION. LIVE AND COLLEAGUES 1331 00:59:19,890 --> 00:59:21,825 LOOKED AT ANOTHER STUDY LOOKING 1332 00:59:21,825 --> 00:59:24,628 AT 841 WOMEN. THEY FOUND THAT 1333 00:59:24,628 --> 00:59:27,197 THE PRESENCE OF DYSMENORRHEA AT 1334 00:59:27,197 --> 00:59:30,033 BASELINE WHICH WAS THE INITIAL 1335 00:59:30,033 --> 00:59:31,234 TIMEFRAME THESE SYMPTOMS WERE 1336 00:59:31,234 --> 00:59:34,371 REPORTED WAS ASSOCIATED WITH A 1337 00:59:34,371 --> 00:59:35,672 41% GREATER RISK OF DEVELOPING 1338 00:59:35,672 --> 00:59:38,675 CHRONIC PAIN TEN YEARS LATER SO 1339 00:59:38,675 --> 00:59:39,876 WE DEFINITELY SEE A RELATIONSHIP 1340 00:59:39,876 --> 00:59:43,246 HERE BUT WE JUST DON'T REALLY 1341 00:59:43,246 --> 00:59:45,615 UNDERSTAND WHY SOME OF THESE 1342 00:59:45,615 --> 00:59:47,217 INDIVIDUALS WHO HAVE MENSTRUAL 1343 00:59:47,217 --> 00:59:50,987 PAIN ARE GOING ONTO DEVELOP 1344 00:59:50,987 --> 00:59:51,688 CHRONIC PAIN. BUT OF COURSE A 1345 00:59:51,688 --> 00:59:54,324 LOT OF RESEARCH BOTH IN THE 1346 00:59:54,324 --> 00:59:54,958 MENSTRUAL PAIN AND THE CHRONIC 1347 00:59:54,958 --> 00:59:57,194 PAIN FIELD HAS LOOKED AT THIS 1348 00:59:57,194 --> 01:00:00,797 ROLE OF CENTRAL SENSITIZATION. 1349 01:00:00,797 --> 01:00:01,798 NOW CENTRAL SENSITIZATION 1350 01:00:01,798 --> 01:00:03,200 BASICALLY MEANS THAT THERE ARE 1351 01:00:03,200 --> 01:00:04,835 THESE LONG LASTING CHANGES IN 1352 01:00:04,835 --> 01:00:06,436 THE CENTRAL NERVOUS SYSTEM. 1353 01:00:06,436 --> 01:00:08,505 THAT AFFECT HOW PAIN IS 1354 01:00:08,505 --> 01:00:09,673 PROCESSED AND EXPERIENCED. AND 1355 01:00:09,673 --> 01:00:13,143 A LOT OF THIS WORK HAS LOOKED AT 1356 01:00:13,143 --> 01:00:14,377 BRAIN STRUCTURE AND FUNCTION. 1357 01:00:14,377 --> 01:00:17,280 IN CHRONIC PAIN AND IN HEALTHY 1358 01:00:17,280 --> 01:00:18,715 POPULATIONS AND SEEN DIFFERENCES 1359 01:00:18,715 --> 01:00:21,418 IN HOW INFORMATION IS PROCESSED. 1360 01:00:21,418 --> 01:00:24,654 AND SO THAT'S ONE WAY OF LOOKING 1361 01:00:24,654 --> 01:00:25,555 AT CENTRAL SENSITIZATION BUT 1362 01:00:25,555 --> 01:00:26,723 ANOTHER WAY THAT A LOT OF 1363 01:00:26,723 --> 01:00:28,725 RESEARCH HAS ALSO FOCUSED ON IS 1364 01:00:28,725 --> 01:00:30,760 SOMETHING CALLED QUANTITATIVE 1365 01:00:30,760 --> 01:00:33,797 SENSORY TESTING WHICH BASICALLY 1366 01:00:33,797 --> 01:00:36,299 MEANS JUST USING DIFFERENT 1367 01:00:36,299 --> 01:00:38,768 PAINFUL STIMULI TO PROVOKE PAIN 1368 01:00:38,768 --> 01:00:40,403 RESPONSES. AND SEE WHAT 1369 01:00:40,403 --> 01:00:43,473 PEOPLE'S LEVELS OF PAIN OR THEIR 1370 01:00:43,473 --> 01:00:45,442 TOLERANCE FOR PAIN IS. NOW 1371 01:00:45,442 --> 01:00:48,578 THESE DATA WERE FROM A REVIEW 1372 01:00:48,578 --> 01:00:50,113 THAT MYSELF AND MY TEAM DID THAT 1373 01:00:50,113 --> 01:00:52,516 WAS PUBLISHED IN 2017 WHERE WE 1374 01:00:52,516 --> 01:00:54,584 LOOKED AT ALL OF THE 1375 01:00:54,584 --> 01:00:56,786 EXPERIMENTAL PAIN FINDINGS IN 1376 01:00:56,786 --> 01:00:58,088 ADULT WOMEN WITH PRIMARY 1377 01:00:58,088 --> 01:01:01,157 DYSMENORRHEA COMPARED TO HEALTHY 1378 01:01:01,157 --> 01:01:04,961 CONTROLS. AND IN GENERAL, NOT 1379 01:01:04,961 --> 01:01:06,830 ENTIRELY CONSISTENTLY BUT IN 1380 01:01:06,830 --> 01:01:09,900 GENERAL ACROSS PAIN STIMULI, 1381 01:01:09,900 --> 01:01:11,501 ACROSS THE MENSTRUAL CYCLE AND 1382 01:01:11,501 --> 01:01:16,406 ACROSS DIFFERENT BODY LOCATIONS, 1383 01:01:16,406 --> 01:01:18,041 WOMEN WITH PRIMARY DYSMENORRHEA 1384 01:01:18,041 --> 01:01:20,343 EXPERIENCED GREATER PAIN 1385 01:01:20,343 --> 01:01:23,380 SENSITIVITY AND LOWER PAIN 1386 01:01:23,380 --> 01:01:25,081 TOLERANCE COMPARED TO HEALTHY 1387 01:01:25,081 --> 01:01:26,449 CONTROLS. AND SO ALTHOUGH MANY 1388 01:01:26,449 --> 01:01:29,319 OF THESE STUDIES AREN'T PERFECT 1389 01:01:29,319 --> 01:01:30,921 IT DOES SUGGEST THAT THERE ARE 1390 01:01:30,921 --> 01:01:34,624 THESE STABLE ALTERATIONS IN PAIN 1391 01:01:34,624 --> 01:01:36,326 PROCESSING THAT PERHAPS IS 1392 01:01:36,326 --> 01:01:40,997 CONTRIBUTING TO PAIN IN THIS 1393 01:01:40,997 --> 01:01:43,466 POPULATION. ONE OF THE AREAS OF 1394 01:01:43,466 --> 01:01:44,668 RESEARCH THAT IS MY AREA OF 1395 01:01:44,668 --> 01:01:45,535 RESEARCH AND ONE OF THE THINGS 1396 01:01:45,535 --> 01:01:47,804 THAT WE WANTED TO LOOK AT IS DO 1397 01:01:47,804 --> 01:01:51,875 WE SEE THESE FINDINGS IN 1398 01:01:51,875 --> 01:01:55,779 ADOLESCENT POPULATIONS. THIS IS 1399 01:01:55,779 --> 01:01:59,316 A PAPER THAT WAS PUBLISHED IN 1400 01:01:59,316 --> 01:02:02,619 219 AND IN THIS SAMPLE IT WAS 1401 01:02:02,619 --> 01:02:05,288 GIRLS AGES 6-25 AND WE DID 1402 01:02:05,288 --> 01:02:06,856 SEVERAL DIFFERENT TYPE OF PAIN 1403 01:02:06,856 --> 01:02:09,292 TESTING PARADIGM TO SEE THEIR 1404 01:02:09,292 --> 01:02:10,126 PAIN RESPONSES. 1405 01:02:10,126 --> 01:02:11,795 SO ON THE LEFT YOU'LL SEE THIS 1406 01:02:11,795 --> 01:02:15,599 WAS THEIR -- THE AMOUNT OF TIME 1407 01:02:15,599 --> 01:02:17,434 THAT THEY WERE TABLE KEEP THEIR 1408 01:02:17,434 --> 01:02:20,470 HAND IN COLD WATER. THIS IS A 1409 01:02:20,470 --> 01:02:22,973 VERY COMMON QUANTITATIVE SENSORY 1410 01:02:22,973 --> 01:02:24,908 TESTING PARADIGM AND IN THIS 1411 01:02:24,908 --> 01:02:27,010 SAMPLE ACROSS THE MENSTRUAL 1412 01:02:27,010 --> 01:02:28,979 CYCLE GIRLS WITH PRIMARY 1413 01:02:28,979 --> 01:02:30,780 DYSMENORRHEA HAD A LOWER PAIN 1414 01:02:30,780 --> 01:02:33,016 TOLERANCE COMPARED TO GIRLS THAT 1415 01:02:33,016 --> 01:02:36,319 WERE IN THE CONTROL GROUP. SO, 1416 01:02:36,319 --> 01:02:41,825 AGAIN, THIS SUGGESTS WE SEE SOME 1417 01:02:41,825 --> 01:02:45,795 OF THESE ALTERATIONS EVEN IN 1418 01:02:45,795 --> 01:02:48,798 YOUNGER POPULATION. NOW WE ALSO 1419 01:02:48,798 --> 01:02:50,867 DID ANOTHER PARADIGM SOMETHING 1420 01:02:50,867 --> 01:02:52,869 CALLED OPINIONED PAIN MODULATION 1421 01:02:52,869 --> 01:02:55,405 AND THIS IS A DIFFERENT TYPE OF 1422 01:02:55,405 --> 01:02:57,340 TESTING PARADIGM MEANT TO ASSESS 1423 01:02:57,340 --> 01:03:01,911 THESE DESCENDING PAIN INHIBITION 1424 01:03:01,911 --> 01:03:08,118 IN THE BRAIN AND THE CENTRAL 1425 01:03:08,118 --> 01:03:09,719 NERVOUS SYSTEM AND WHAT IS 1426 01:03:09,719 --> 01:03:16,259 DIFFERENT IS THERE WAS NO GROUP 1427 01:03:16,259 --> 01:03:17,560 DIFFERENCES IN THIS PARTICULAR 1428 01:03:17,560 --> 01:03:18,928 PAIN PARADIGM. THERE ARE SOME 1429 01:03:18,928 --> 01:03:21,131 DATA SUGGESTING THERE'S ENHANCED 1430 01:03:21,131 --> 01:03:22,465 PAIN SENSITIVITY. BUT SOME OF 1431 01:03:22,465 --> 01:03:24,434 THESE OTHER PARADIGMS, THAT ARE 1432 01:03:24,434 --> 01:03:26,369 PRETTY WIDELY USED IN CHRONIC 1433 01:03:26,369 --> 01:03:28,972 PAIN POPULATIONS, WE DID NOT 1434 01:03:28,972 --> 01:03:31,775 FIND EVIDENCE OF THAT. IN 1435 01:03:31,775 --> 01:03:33,910 ADOLESCENTS IN YOUNG ADULTS WITH 1436 01:03:33,910 --> 01:03:42,118 PRIMARY DYSMENORRHEA. SO WHAT 1437 01:03:42,118 --> 01:03:43,219 REALLY INTERESTING EMERGENT 1438 01:03:43,219 --> 01:03:44,487 RESEARCH THAT WE'RE STARTING TO 1439 01:03:44,487 --> 01:03:46,256 LOOK AT IS FROM A BROADER 1440 01:03:46,256 --> 01:03:47,223 PERSPECTIVE AND A NUMBER OF MY 1441 01:03:47,223 --> 01:03:48,725 COLLEAGUES ARE GOING SOME WORK 1442 01:03:48,725 --> 01:03:51,361 IN THIS AREA AND THIS HAS BEEN 1443 01:03:51,361 --> 01:03:55,231 LOOKED AT IN MORE CHRONIC PAIN 1444 01:03:55,231 --> 01:04:00,737 POPULATIONS BUT THIS IS TAKING 1445 01:04:00,737 --> 01:04:06,710 CENTRAL SENSATION AND THIS IS 1446 01:04:06,710 --> 01:04:08,511 LOOKING AT ALL SENSITIVITY TO 1447 01:04:08,511 --> 01:04:11,414 OTHER SENSORY STIMULI INCLUDING 1448 01:04:11,414 --> 01:04:15,151 LIGHT, SOUND, HEAT, COLD, SMELL, 1449 01:04:15,151 --> 01:04:17,654 TOUCH, TASTE AND EVEN ALLERGIES. 1450 01:04:17,654 --> 01:04:20,090 THIS IS REALLY EXPANDING BEYOND 1451 01:04:20,090 --> 01:04:21,758 JUST WHAT WE HAVE TYPICALLY USED 1452 01:04:21,758 --> 01:04:23,426 IN OUR PAIN TESTING PARADIGMS 1453 01:04:23,426 --> 01:04:25,261 AND PERHAPS IS GOING TO GIVE US 1454 01:04:25,261 --> 01:04:28,598 SOME ADDITIONAL CLUES INTO WHO 1455 01:04:28,598 --> 01:04:31,301 IS REALLY AT RISK FOR DEVELOPING 1456 01:04:31,301 --> 01:04:33,069 CHRONIC PAIN BECAUSE OF THIS 1457 01:04:33,069 --> 01:04:36,473 CENTRAL SENSITIZATION. NOW MY 1458 01:04:36,473 --> 01:04:43,113 COLLEAGUES DR. KEVIN HELLMAN 1459 01:04:43,113 --> 01:04:45,415 DEVELOPED A PAPER LOOKING AT 1460 01:04:45,415 --> 01:04:48,752 THIS IDEA OF MULTIMODAL HYPER 1461 01:04:48,752 --> 01:04:51,421 SENSITIVITY. THESE WERE FROM A 1462 01:04:51,421 --> 01:04:53,923 SAMPLE OF TWO HUNDRED YOUNG 1463 01:04:53,923 --> 01:04:56,459 ADULT WOMEN. THAT HAD EITHER 1464 01:04:56,459 --> 01:04:58,261 MENSTRUAL PAIN, BLADDER PAIN 1465 01:04:58,261 --> 01:05:00,363 SYNDROME, OR A NON PELVIC 1466 01:05:00,363 --> 01:05:01,498 CHRONIC PAIN. 1467 01:05:01,498 --> 01:05:03,566 AND THEY WENT THROUGH A SERIES 1468 01:05:03,566 --> 01:05:07,403 OF DIFFERENT TESTING PARADIGMS. 1469 01:05:07,403 --> 01:05:12,175 AND ULTIMATELY PUT TOGETHER A 1470 01:05:12,175 --> 01:05:13,710 COMPOSITE MEASURE. WHAT THEY 1471 01:05:13,710 --> 01:05:17,347 CALL MULTIMODAL HYPERSENSITIVITY 1472 01:05:17,347 --> 01:05:20,083 THAT INVOLVE SENSITIVITY TO 1473 01:05:20,083 --> 01:05:21,885 AUDITORY, VISUAL AND SOME PAIN 1474 01:05:21,885 --> 01:05:24,621 STIMULI AND PUTTING TOGETHER 1475 01:05:24,621 --> 01:05:26,489 THIS COMPOSITE MEASURE WAS 1476 01:05:26,489 --> 01:05:29,859 ACTUALLY THE BEST PREDICTOR OF 1477 01:05:29,859 --> 01:05:31,761 PELVIC PAIN FOUR YEARS LATER 1478 01:05:31,761 --> 01:05:34,964 EVEN BETTER PREDICTOR THAN THEIR 1479 01:05:34,964 --> 01:05:37,033 BASELINE LEVEL OF PELVIC PAIN AS 1480 01:05:37,033 --> 01:05:38,601 WELL AS PRESSURE PAIN THRESHOLDS 1481 01:05:38,601 --> 01:05:43,306 AND BLADDER HYPERSENSITIVITY. 1482 01:05:43,306 --> 01:05:47,677 SO IT REALLY SUGGESTS THIS 1483 01:05:47,677 --> 01:05:48,778 BROADER PERSPECTIVE MIGHT BE 1484 01:05:48,778 --> 01:05:50,380 ACTUALLY A BETTER PREDICTOR OF 1485 01:05:50,380 --> 01:05:51,881 WHO IS ACTUALLY GOING TO DEVELOP 1486 01:05:51,881 --> 01:05:53,283 CHRONIC PAIN. AND SO WE HAVE 1487 01:05:53,283 --> 01:05:55,885 STARTED TO LOOK AT THIS IN MY 1488 01:05:55,885 --> 01:05:58,454 CURRENT STUDY. SO IN THIS 1489 01:05:58,454 --> 01:06:00,957 STUDY, THAT IS ONGOING, ALTHOUGH 1490 01:06:00,957 --> 01:06:04,527 WE HAVE COLLECTED MUCH OF THE 1491 01:06:04,527 --> 01:06:08,264 DATA, IT'S 141 ADOLESCENT GIRLS 1492 01:06:08,264 --> 01:06:11,334 AGES 13-19 AND THE STUDY 1493 01:06:11,334 --> 01:06:12,869 INCLUDED INDIVIDUALS WITH A 1494 01:06:12,869 --> 01:06:17,340 RANGE OF MENSTRUAL PAIN SEVERITY 1495 01:06:17,340 --> 01:06:22,212 LEVELS SO WE INCLUDED GIRLS THAT 1496 01:06:22,212 --> 01:06:23,580 HAD MILD PAIN ALL THE WAY TO 1497 01:06:23,580 --> 01:06:24,814 SEVERE PAIN AND WHAT IS 1498 01:06:24,814 --> 01:06:26,382 IMPORTANT ABOUT THIS POPULATION 1499 01:06:26,382 --> 01:06:28,418 NOT JUST THAT THEY'RE 1500 01:06:28,418 --> 01:06:29,485 ADOLESCENTS AND KIND OF IN THE 1501 01:06:29,485 --> 01:06:31,120 EARLIER STAGES OF THIS 1502 01:06:31,120 --> 01:06:32,288 DEVELOPMENT IS THAT WE EXCLUDED 1503 01:06:32,288 --> 01:06:35,124 ANYBODY WITH ANY TYPE OF CHRONIC 1504 01:06:35,124 --> 01:06:38,361 PAIN CONDITION. SO THIS IS A 1505 01:06:38,361 --> 01:06:41,898 VERY COMMUNITY-BASED SAMPLE OF 1506 01:06:41,898 --> 01:06:44,100 TYPICAL ADOLESCENT WITH 1507 01:06:44,100 --> 01:06:46,903 MENSTRUAL PAIN WE ALSO EXCLUDE 1508 01:06:46,903 --> 01:06:48,104 INDIVIDUALS WITH MAJOR 1509 01:06:48,104 --> 01:06:49,539 PSYCHIATRIC ISSUES AND THAT IS 1510 01:06:49,539 --> 01:06:51,875 BECAUSE OF THE STUDY INCLUDED AN 1511 01:06:51,875 --> 01:06:53,676 SMRI COMPONENT. FOR THE DATA 1512 01:06:53,676 --> 01:06:55,945 I'M PRESENTING TODAY THEY WERE 1513 01:06:55,945 --> 01:06:57,413 ASSESSED AT BASELINE AS WELL AS 1514 01:06:57,413 --> 01:06:59,949 MONTHLY FOR 12 MONTHS AND THE 1515 01:06:59,949 --> 01:07:04,020 MEASURES WE USED WE USED A 1516 01:07:04,020 --> 01:07:07,624 SELF-REPORT MEASURE CALLED THE 1517 01:07:07,624 --> 01:07:08,825 HYPERSENSITIVITY SCALE. AND 1518 01:07:08,825 --> 01:07:13,897 SPLIT THEM INTO TWO GROUPS HIGH 1519 01:07:13,897 --> 01:07:16,132 VERSUS LOW AND LOOKED AT THE 1520 01:07:16,132 --> 01:07:18,134 SEVERITY TRAJECTORY OVER 12 1521 01:07:18,134 --> 01:07:21,337 MONTHS AND THEN THE PRIMARY 1522 01:07:21,337 --> 01:07:23,473 OUTCOME WAS THIS MEASURE OF PAIN 1523 01:07:23,473 --> 01:07:25,575 WIDESPREADNESS TRAJECTORY. NOW 1524 01:07:25,575 --> 01:07:27,610 PAIN WIDESPREADNESS WAS DEFINED 1525 01:07:27,610 --> 01:07:30,813 AS THE NUMBER OF LOCATIONS ON 1526 01:07:30,813 --> 01:07:32,248 THEIR BOD THEY THAT THEY 1527 01:07:32,248 --> 01:07:35,184 ENDORSED AS PAINFUL IN THE PAST 1528 01:07:35,184 --> 01:07:36,953 MONTH. WE USE THIS BODY MAP 1529 01:07:36,953 --> 01:07:38,321 WHICH YOU CAN SEE THERE FROM THE 1530 01:07:38,321 --> 01:07:40,089 STUDY AND WE ADDED UP THE NUMBER 1531 01:07:40,089 --> 01:07:42,058 OF BODY PAIN LOCATIONS THAT THEY 1532 01:07:42,058 --> 01:07:43,159 WERE ENDORSING NOW THE REASON 1533 01:07:43,159 --> 01:07:46,262 THAT THIS IS IMPORTANT IS 1534 01:07:46,262 --> 01:07:50,533 BECAUSE MOST GIRLS AT THIS AGE 1535 01:07:50,533 --> 01:07:52,068 WILL NOT HAVE DEVELOPED CHRONIC 1536 01:07:52,068 --> 01:07:53,436 PAIN BUT THIS PAIN 1537 01:07:53,436 --> 01:07:55,338 WIDESPREADNESS IS A PROXY FOR 1538 01:07:55,338 --> 01:07:58,107 CHRONIC PAIN. THE EXTENT OF THE 1539 01:07:58,107 --> 01:08:00,343 PAIN WIDESPREADNESS IS 1540 01:08:00,343 --> 01:08:01,044 ASSOCIATED WITH MANY CHRONIC 1541 01:08:01,044 --> 01:08:03,713 PAIN CONDITIONS THAT ALLOWS US 1542 01:08:03,713 --> 01:08:05,581 TO SEE WHO ARE AT MUCH GREATER 1543 01:08:05,581 --> 01:08:06,516 RISK FOR CHRONIC PAIN AND WHEN 1544 01:08:06,516 --> 01:08:07,917 WE LOOKED AT DIFFERENT GROUPS, 1545 01:08:07,917 --> 01:08:09,352 WHICH I'LL BE PRESENTING IN JUST 1546 01:08:09,352 --> 01:08:12,221 A MOMENT, WE FOUND THAT OF THE 1547 01:08:12,221 --> 01:08:16,059 SAMPLE, 80 WERE GROUPED INTO THE 1548 01:08:16,059 --> 01:08:18,361 GROUP THAT SHOWED NO INCREASE IN 1549 01:08:18,361 --> 01:08:19,896 MENSTRUAL PAIN OVER TWELVE 1550 01:08:19,896 --> 01:08:20,997 MONTHS IT EITHER STAYED THE SAME 1551 01:08:20,997 --> 01:08:26,069 OR WENT DOWN AND 61 IN A GRIPE 1552 01:08:26,069 --> 01:08:27,637 GROUP SHOWED AN INCREASE IN 1553 01:08:27,637 --> 01:08:28,671 TWELVE MONTHS. 1554 01:08:28,671 --> 01:08:32,008 AND SO WHAT WE FOUND WAS THAT 1555 01:08:32,008 --> 01:08:33,910 FOR THE GROUP THAT SHOWED NO 1556 01:08:33,910 --> 01:08:35,511 INCREASE IN MENSTRUAL PAIN, OVER 1557 01:08:35,511 --> 01:08:37,880 THE TWELVE MONTHS, THE NUMBER OF 1558 01:08:37,880 --> 01:08:39,248 BODY PAIN LOCATIONS THAT THEY 1559 01:08:39,248 --> 01:08:41,784 ENDORSED GENERALLY WENT DOWN. 1560 01:08:41,784 --> 01:08:45,054 BUT IF YOU HAD HIGH SENSORY 1561 01:08:45,054 --> 01:08:46,789 HYPERSENSITIVITY, YOU STILL HAD 1562 01:08:46,789 --> 01:08:48,691 MORE BODY PAIN LOCATIONS THAN 1563 01:08:48,691 --> 01:08:50,093 THE LOW GROUP. SO YOU'RE STILL 1564 01:08:50,093 --> 01:08:54,797 AT A GREATER RISK FOR CHRONIC 1565 01:08:54,797 --> 01:08:58,267 PAIN. BUT IF YOU LOOKED AT THE 1566 01:08:58,267 --> 01:08:59,936 GROUP THAT SHOWED AN INCREASE 1567 01:08:59,936 --> 01:09:02,271 OTHER THE TWELVE MONTHS, IF YOU 1568 01:09:02,271 --> 01:09:03,806 HAD HIGH SENSORY 1569 01:09:03,806 --> 01:09:04,941 HYPERSENSITIVITY THE NUMBER OF 1570 01:09:04,941 --> 01:09:06,142 BODY PAIN LOCATIONS THAT YOU 1571 01:09:06,142 --> 01:09:09,012 WERE ENDORSING WENT UP 1572 01:09:09,012 --> 01:09:12,181 SIGNIFICANTLY. SO THIS REALLY 1573 01:09:12,181 --> 01:09:15,551 SHOWS THAT THIS GROUP IS THE 1574 01:09:15,551 --> 01:09:16,519 POTENTIAL GROUP AT GREATEST RISK 1575 01:09:16,519 --> 01:09:18,554 FOR CHRONIC PAIN. THOSE WHO 1576 01:09:18,554 --> 01:09:21,891 HAVE AN INCREASE IN MENSTRUAL 1577 01:09:21,891 --> 01:09:28,464 PAIN AS WELL AS THOSE WITH 1578 01:09:28,464 --> 01:09:34,670 MULTISENSORY SENSITIVITY. WE 1579 01:09:34,670 --> 01:09:36,773 NEED TO THINK OUTSIDE THE BOX OR 1580 01:09:36,773 --> 01:09:38,674 OUTSIDE THE UTERUS. PAIN 1581 01:09:38,674 --> 01:09:40,543 SENSITIVITY IS ONE ASPECT OF 1582 01:09:40,543 --> 01:09:41,644 THIS AND ALTHOUGH I THINK MANY 1583 01:09:41,644 --> 01:09:43,146 OF US HAVE KNOWN THIS, WE 1584 01:09:43,146 --> 01:09:45,148 HAVEN'T REALLY IMPLEMENTED THIS 1585 01:09:45,148 --> 01:09:48,684 INTO OUR RESEARCH PROTOCOLS. 1586 01:09:48,684 --> 01:09:50,190 AND PERHAPS (NO AUDIO) LEAD TO 1587 01:09:50,190 --> 01:09:51,491 CHRONIC PAIN. THE EVIDENCE IS 1588 01:09:51,491 --> 01:09:54,861 VERY COMPELLING. IN MY OPINION. 1589 01:09:54,861 --> 01:09:56,730 THIS TYPE OF CONSTRUCT HAS BEEN 1590 01:09:56,730 --> 01:09:59,099 STUDIED IN CHRONIC PAIN 1591 01:09:59,099 --> 01:10:02,135 SYNDROMES FOR AWHILE BUT PERHAPS 1592 01:10:02,135 --> 01:10:03,403 WE CAN ACTUALLY IDENTIFY THIS -- 1593 01:10:03,403 --> 01:10:05,706 THESE ALTERATIONS AND SENSORY 1594 01:10:05,706 --> 01:10:08,141 PROCESSING, MUCH EARLIER ON. 1595 01:10:08,141 --> 01:10:11,011 AND BE ABLE TO ADDRESS THESE 1596 01:10:11,011 --> 01:10:12,446 SYMPTOMS IN ORDER TO PREVENT THE 1597 01:10:12,446 --> 01:10:14,881 DEVELOPMENT OF CHRONIC PAIN. WE 1598 01:10:14,881 --> 01:10:17,684 NEED MORE LONGITUDINAL STUDIES 1599 01:10:17,684 --> 01:10:22,456 ON MAN MENSTRUAL PAIN TO BETTER 1600 01:10:22,456 --> 01:10:23,890 CHARACTERIZE THESE FACTORS. 1601 01:10:23,890 --> 01:10:25,692 BUT THIS BROADER PERSPECTIVE 1602 01:10:25,692 --> 01:10:27,394 OPENS UP THE POSSIBILITY OF 1603 01:10:27,394 --> 01:10:28,829 NEWER TREATMENT APPROACHES 1604 01:10:28,829 --> 01:10:32,432 IDEALLY TO REDUCE MULTISENSORY 1605 01:10:32,432 --> 01:10:34,368 SENSITIVITY THROUGH BEHAVIORAL 1606 01:10:34,368 --> 01:10:38,205 STRATEGIES, OR MEDICATION OR 1607 01:10:38,205 --> 01:10:41,541 OTHER TREATMENTS BASED ON 1608 01:10:41,541 --> 01:10:45,278 MECHANISMS INVOLVED IN THIS TO 1609 01:10:45,278 --> 01:10:46,747 IDEALLY PREVENT THE PAIN. SO I 1610 01:10:46,747 --> 01:10:50,817 JUST WOULD LIKE TO ACKNOWLEDGE 1611 01:10:50,817 --> 01:10:54,621 MY TEAM AT MCLANE HOSPITAL AND 1612 01:10:54,621 --> 01:10:56,656 AS WELL AS THE ONGOING GRANT 1613 01:10:56,656 --> 01:10:57,557 SUPPORT FROM NICHD. THANK YOU 1614 01:10:57,557 --> 01:11:01,228 SO MUCH. 1615 01:11:01,228 --> 01:11:04,664 >> THANK YOU SO MUCH DR. PAYNE. 1616 01:11:04,664 --> 01:11:07,968 I -- AM MIND BLOWN OVER HERE I 1617 01:11:07,968 --> 01:11:08,969 NEVER WOULD HAVE THOUGHT AS 1618 01:11:08,969 --> 01:11:10,604 MITCH AS I ALREADY WORK IN THIS 1619 01:11:10,604 --> 01:11:13,340 FIELD AND KNOW ABOUT PELVIC PAIN 1620 01:11:13,340 --> 01:11:14,374 I NEVER WOULD HAVE THOUGHT ONE 1621 01:11:14,374 --> 01:11:16,576 OF THE BEST PREDICTORS WAS 1622 01:11:16,576 --> 01:11:17,677 INCLUDING SENSITIVITY TO LIGHT 1623 01:11:17,677 --> 01:11:19,746 AND SENSITIVITY TO SOUND AS A -- 1624 01:11:19,746 --> 01:11:22,949 AS A PREDICTOR OF PELVIC PAIN OR 1625 01:11:22,949 --> 01:11:24,551 MENSTRUAL PAIN THAT IS, YOU 1626 01:11:24,551 --> 01:11:25,419 KNOW, I DON'T THINK IT IS 1627 01:11:25,419 --> 01:11:28,922 SOMETHING WE THINK OF SO THAT'S 1628 01:11:28,922 --> 01:11:30,123 INCREDIBLE. AND I THINK THE 1629 01:11:30,123 --> 01:11:31,391 AUDIENCE IS THINKING THE SAME 1630 01:11:31,391 --> 01:11:33,660 THING THAT I AM WHICH IS NOW 1631 01:11:33,660 --> 01:11:36,029 THAT WE KNOW THIS, HOW DO WE 1632 01:11:36,029 --> 01:11:38,899 REALLY USE THIS? HAVE YOU SEEN 1633 01:11:38,899 --> 01:11:41,168 THIS CHANGE THERE GUIDELINES? 1634 01:11:41,168 --> 01:11:43,370 IS ANYBODY USING MMH IN THE 1635 01:11:43,370 --> 01:11:48,775 CLINIC TO START TO HELP PEOPLE? 1636 01:11:48,775 --> 01:11:50,777 >> I DON'T THINK IT HAS 1637 01:11:50,777 --> 01:11:51,678 TRANSLATED TO CLINICAL WORK JUST 1638 01:11:51,678 --> 01:11:55,449 YET. I KNOW MY COLLEAGUES 1639 01:11:55,449 --> 01:11:56,883 DR. HELLMAN ARE DOING A LOT OF 1640 01:11:56,883 --> 01:11:58,952 WORK IN THIS AREA, SOME REALLY 1641 01:11:58,952 --> 01:12:00,987 GROUND BREAKING WORK AND ANOTHER 1642 01:12:00,987 --> 01:12:03,290 DOCTOR AS WELL. BUT I THINK 1643 01:12:03,290 --> 01:12:06,126 THIS IS JUST A REALLY 1644 01:12:06,126 --> 01:12:07,461 FASCINATING AREA THAT REALLY 1645 01:12:07,461 --> 01:12:11,431 SPEAKS TO THE ROLE OF THE BRAIN 1646 01:12:11,431 --> 01:12:14,701 AND CENTRAL SENSITIZATION BUT 1647 01:12:14,701 --> 01:12:16,636 PERHAPS PART OF WHAT HAS BEEN 1648 01:12:16,636 --> 01:12:19,439 CONFUSING IN THE LITERATURE THUS 1649 01:12:19,439 --> 01:12:21,508 FAR PARTICULARLY WITH MENSTRUAL 1650 01:12:21,508 --> 01:12:22,843 PAIN IS IT HAS BEEN SUCH A 1651 01:12:22,843 --> 01:12:26,246 NARROW FOCUS AND I THINK THAT I 1652 01:12:26,246 --> 01:12:27,814 SEE THIS AS KIND OF THE NEXT 1653 01:12:27,814 --> 01:12:30,951 AREA THAT WE REALLY NEED TO 1654 01:12:30,951 --> 01:12:32,986 INVESTIGATE. SO MY LAB IS KIND 1655 01:12:32,986 --> 01:12:34,855 OF WORKING AT, LIKE, THINKING 1656 01:12:34,855 --> 01:12:37,524 ABOUT WHAT ARE THE MECHANISMS 1657 01:12:37,524 --> 01:12:38,525 AND WE'RE CONSIDERING DIFFERENT 1658 01:12:38,525 --> 01:12:41,628 THINGS INCLUDING ALTERATIONS IN 1659 01:12:41,628 --> 01:12:43,096 THE GUT MICROBIOME BECAUSE THAT 1660 01:12:43,096 --> 01:12:45,532 IS A FACTOR THAT WE KNOW IS 1661 01:12:45,532 --> 01:12:47,367 ASSOCIATED WITH HYPERSENSITIVITY 1662 01:12:47,367 --> 01:12:50,570 IN OTHER AREAS TOO AND THIS 1663 01:12:50,570 --> 01:12:52,105 PERHAPS COULD BE ONE OF THE 1664 01:12:52,105 --> 01:12:52,939 THINGS INVOLVED. 1665 01:12:52,939 --> 01:12:54,641 >> THAT'S INCREDIBLE. I MEAN IT 1666 01:12:54,641 --> 01:12:56,576 SOUNDS LIKE TO ME THEN IF I WAS 1667 01:12:56,576 --> 01:12:58,879 A PATIENT WITH MENSTRUAL PAIN OR 1668 01:12:58,879 --> 01:13:00,614 PELVIC PAIN AND I ALSO HAD THESE 1669 01:13:00,614 --> 01:13:02,749 OTHER HYPERSENSITIVITIES THAT IS 1670 01:13:02,749 --> 01:13:04,351 SOMETHING I CAN BRING UP WITH MY 1671 01:13:04,351 --> 01:13:09,022 CLINICIAN AND MAKE IT KNOWN TO 1672 01:13:09,022 --> 01:13:12,559 THEM I HAVE OTHER STUFF GOING 1673 01:13:12,559 --> 01:13:12,726 ON. 1674 01:13:12,726 --> 01:13:14,628 >> YES THAT COULD BE A RISK 1675 01:13:14,628 --> 01:13:16,029 FACTOR. I'M A PSYCHOLOGIST AND 1676 01:13:16,029 --> 01:13:18,331 I COME FROM A BEHAVIORAL 1677 01:13:18,331 --> 01:13:19,432 PERSPECTIVE BUT THERE ARE A FEW 1678 01:13:19,432 --> 01:13:22,369 PAPERS PUBLISHED ON REDUCING 1679 01:13:22,369 --> 01:13:25,171 THIS MORE WIDESPREAD SENSORY 1680 01:13:25,171 --> 01:13:27,240 SENSITIVITY WITH BEHAVIORAL 1681 01:13:27,240 --> 01:13:30,777 STRATEGIES AND SO THERE'S A LOT 1682 01:13:30,777 --> 01:13:31,578 OF POSSIBILITY HERE. 1683 01:13:31,578 --> 01:13:34,014 >> REALLY TRYING TO GET AHEAD OF 1684 01:13:34,014 --> 01:13:35,482 THAT CENTRAL SENSITIZATION SO 1685 01:13:35,482 --> 01:13:37,717 YOU STOP IT BEFORE IT BECOMES A 1686 01:13:37,717 --> 01:13:41,821 BODY WIDE PROBLEM. THAT'S 1687 01:13:41,821 --> 01:13:43,023 INCREDIBLE. THANK YOU SO MUCH, 1688 01:13:43,023 --> 01:13:45,258 DR. PAYNE, THANK YOU FOR YOUR 1689 01:13:45,258 --> 01:13:47,294 WORK, ESPECIALLY IN THE 1690 01:13:47,294 --> 01:13:47,894 ADOLESCENCE FIELD. GETTING 1691 01:13:47,894 --> 01:13:49,763 AHEAD OF THIS PAIN AND 1692 01:13:49,763 --> 01:13:51,298 UNDERSTANDING IT WHEN GIRLS AND 1693 01:13:51,298 --> 01:13:53,667 WOMEN ARE YOUNG. AND WE CAN 1694 01:13:53,667 --> 01:13:55,569 REALLY TRY TO PREVENT SOME OF 1695 01:13:55,569 --> 01:13:57,103 THE PAIN BEFORE WE EVEN HAVE TO 1696 01:13:57,103 --> 01:14:05,412 TREAT IT IS SO, SO KEY. SO WE 1697 01:14:05,412 --> 01:14:07,781 ARE GOING TO MOVE ON NOW TO OUR 1698 01:14:07,781 --> 01:14:08,348 NEXT SPEAKER. WE HAVE HAD 1699 01:14:08,348 --> 01:14:10,917 SEVERAL QUESTIONS IN THE CHAT 1700 01:14:10,917 --> 01:14:12,252 ABOUT THERAPEUTICS SO I AM JUST 1701 01:14:12,252 --> 01:14:13,520 GOING TO HAVE DR. GOLD STEIN 1702 01:14:13,520 --> 01:14:15,922 ANSWER ALL OF THEM BUT DR. GOLD 1703 01:14:15,922 --> 01:14:19,092 STEIN IS THE DIRECTOR OF THE 1704 01:14:19,092 --> 01:14:25,999 CENTERS FOR VAGINAL DISORDERS 1705 01:14:25,999 --> 01:14:27,100 AND WILL SPEAK ABOUT A RECENT 1706 01:14:27,100 --> 01:14:29,336 SUMMIT AND TELL US ABOUT WHAT 1707 01:14:29,336 --> 01:14:31,071 WENT ON THAT MEETING. 1708 01:14:31,071 --> 01:14:32,505 >> THANK YOU VERY MUCH. I WANT 1709 01:14:32,505 --> 01:14:34,374 TO THANK YOU FOR HAVING ME 1710 01:14:34,374 --> 01:14:37,611 DR. AUN AND INVITING ME FOR THIS 1711 01:14:37,611 --> 01:14:41,748 VERY IMPORTANT MEETING AS I H 1712 01:14:41,748 --> 01:14:46,252 HEAR -- SIT HERE AND LISTEN I 1713 01:14:46,252 --> 01:14:49,589 CAN'T BE BY ENVIOUS OF THE WORK 1714 01:14:49,589 --> 01:14:52,759 THAT IS GOING ON IN THE WORLD OF 1715 01:14:52,759 --> 01:14:54,828 ENDOMETRIOSIS AND HOW FAR ALONG 1716 01:14:54,828 --> 01:14:58,198 THEY ARE COMPARED TO HOW FAR 1717 01:14:58,198 --> 01:15:00,600 ALONG WE ARE WITH THERAPEUTICS 1718 01:15:00,600 --> 01:15:02,235 IN AS A RULE VOE DIN YA. SO 1719 01:15:02,235 --> 01:15:03,436 THIS KIND OF MEETING THAT I'M 1720 01:15:03,436 --> 01:15:06,806 GOING TO TALK ABOUT IS BASICALLY 1721 01:15:06,806 --> 01:15:17,017 TO MOVE US TOWARDS TREATMENT. 1722 01:15:17,017 --> 01:15:18,451 MY MAIN RELEVANT DISCLOSURE IS 1723 01:15:18,451 --> 01:15:20,887 THAT I AM THE PRESIDENT OF THE 1724 01:15:20,887 --> 01:15:22,422 GYNECOLOGIC CANCERS RESEARCH 1725 01:15:22,422 --> 01:15:23,757 FOUNDATION WHICH IS ONE OF THE 1726 01:15:23,757 --> 01:15:25,358 FOUR SPONSORS OF THIS MEETING 1727 01:15:25,358 --> 01:15:29,262 THAT WE RECENTLY HAD. E PRESIDEC 1728 01:15:29,262 --> 01:15:30,964 CANCERS RESEARCH FOUNDATION 1729 01:15:30,964 --> 01:15:31,498 WHICH IS ONE OF THE FOUR 1730 01:15:31,498 --> 01:15:32,132 SPONSORS OF THIS MEETING THAT WE 1731 01:15:32,132 --> 01:15:32,799 RECENTLY HAD. SO THE CONCEPTION 1732 01:15:32,799 --> 01:15:34,567 OF THIS RESEARCH SUMMIT WAS THAT 1733 01:15:34,567 --> 01:15:37,704 APPROXIMATELY NINE YEARS AGO 1734 01:15:37,704 --> 01:15:43,543 ISSVD, ISSWSH CAME TOGETHER TO 1735 01:15:43,543 --> 01:15:45,945 PUBLISH AND DEVELOP THE 1736 01:15:45,945 --> 01:15:47,781 VULVODYNIA NOMENCLATURE. ONE OF 1737 01:15:47,781 --> 01:15:49,516 THE MOST IMPORTANT STATEMENTS 1738 01:15:49,516 --> 01:15:50,850 WAS THAT TREATMENT IS SHOULD BE 1739 01:15:50,850 --> 01:15:53,953 CHOSEN ACCORDING TO THE 1740 01:15:53,953 --> 01:15:54,988 CHARACTERISTICS OF THE 1741 01:15:54,988 --> 01:15:56,589 INDIVIDUAL CASE AND A POSSIBLE 1742 01:15:56,589 --> 01:15:58,391 ASSOCIATED FACTORS RATHER THAN A 1743 01:15:58,391 --> 01:16:01,761 ONE SIZE FITS ALL APPROACH TO 1744 01:16:01,761 --> 01:16:05,665 THE TREATMENT OF VULVAR PAIN OR 1745 01:16:05,665 --> 01:16:06,900 VULVODYNIA. UNFORTUNATELY AS 1746 01:16:06,900 --> 01:16:08,868 MANY OF YOU ARE ALL TOO WELL 1747 01:16:08,868 --> 01:16:15,341 AWARE THE EFFORT TO DEVELOP NEW 1748 01:16:15,341 --> 01:16:18,645 THERAPIES FOR VULVODYNIA HAS NOT 1749 01:16:18,645 --> 01:16:20,146 MOVED FORWARD IN ANY SIGNIFICANT 1750 01:16:20,146 --> 01:16:22,282 WAY HOWEVER RESEARCH HAS MADE 1751 01:16:22,282 --> 01:16:23,516 PROGRESS IN IDENTIFYING TARGETED 1752 01:16:23,516 --> 01:16:33,860 PATH -- PATH WEIS. 1753 01:16:34,861 --> 01:16:39,299 WE CON ACCEPT CHILDIZED A SUMMIT 1754 01:16:39,299 --> 01:16:40,867 TO LOOK AT TREATMENTS FOR 1755 01:16:40,867 --> 01:16:43,103 VULVODYNIA BASED ON OUR CURRENT 1756 01:16:43,103 --> 01:16:46,072 SUNS UNDERSTANDING OF THE 1757 01:16:46,072 --> 01:16:48,174 PATHOPHYSIOLOGY OF VULVA DIN YA. 1758 01:16:48,174 --> 01:16:51,811 WE WANTED TO DEVELOP AN AS IS 1759 01:16:51,811 --> 01:16:53,012 CONSENSUS AMONG PARTICIPANTS AS 1760 01:16:53,012 --> 01:16:55,381 TO WHEN ARE THE MOST PROMISING 1761 01:16:55,381 --> 01:16:57,684 AND FEASIBLE OF THESE NOVEL 1762 01:16:57,684 --> 01:16:59,919 IDEAS AND TO PRODUCE A WHITE 1763 01:16:59,919 --> 01:17:02,722 PAPER OR SIMILAR DOCUMENT THAT 1764 01:17:02,722 --> 01:17:04,124 COULD BE PRESENTED TO POTENTIAL 1765 01:17:04,124 --> 01:17:06,059 FUNDING ORGANIZATIONS INCLUDING 1766 01:17:06,059 --> 01:17:10,697 BUT NOT LIMITED TO NICHD, OTHER 1767 01:17:10,697 --> 01:17:11,498 GOVERNMENTAL AGENCIES, LARGE 1768 01:17:11,498 --> 01:17:13,299 PRIVATE FOUNDATION THAT CARE 1769 01:17:13,299 --> 01:17:16,169 ABOUT WOMEN'S HEALTH, PHARMA, 1770 01:17:16,169 --> 01:17:17,270 AS -- BECAUSE THERE'S VERY 1771 01:17:17,270 --> 01:17:21,007 LITTLE INTEREST IN THE 1772 01:17:21,007 --> 01:17:22,942 PHARMACEUTICAL INDUSTRY ABOUT 1773 01:17:22,942 --> 01:17:23,643 VULVODYNIA AS WELL AS OTHER 1774 01:17:23,643 --> 01:17:28,381 POTENTIAL STAKEHOLDER SOCIETIES. 1775 01:17:28,381 --> 01:17:31,785 SO THE SPONSORS OF THIS MIGHT 1776 01:17:31,785 --> 01:17:32,685 WERE THE INTERNATIONAL SOCIETY 1777 01:17:32,685 --> 01:17:35,054 FOR THE STUDY OF WOMEN'S SEXUAL 1778 01:17:35,054 --> 01:17:36,623 HEALTH. THE NATIONAL VULVODYNIA 1779 01:17:36,623 --> 01:17:37,624 ASSOCIATION. TIGHT LIPPED WHICH 1780 01:17:37,624 --> 01:17:39,759 YOU'LL HEAR FROM IN A FEW 1781 01:17:39,759 --> 01:17:41,594 MINUTES AND THE GYNECOLOGIC 1782 01:17:41,594 --> 01:17:43,396 CANCERS RESEARCH FOUNDATION AND 1783 01:17:43,396 --> 01:17:45,832 EACH SPONSOR CHOSE TWO PEOPLE TO 1784 01:17:45,832 --> 01:17:49,302 PARTICIPATE IN THE STEERING 1785 01:17:49,302 --> 01:17:52,038 COMMITTEE TO IDENTIFY TOPICS AND 1786 01:17:52,038 --> 01:17:54,808 POTENTIAL PARTICIPANTS WERE THEN 1787 01:17:54,808 --> 01:17:57,510 INVITED THE SUMMIT WAS VERY 1788 01:17:57,510 --> 01:18:00,947 RECENTLY HELD. LESS THAN TWO 1789 01:18:00,947 --> 01:18:03,483 MONTHS AGO IN FALLS CHURCH, 1790 01:18:03,483 --> 01:18:07,654 VIRGINIA, A SUBURB OF 1791 01:18:07,654 --> 01:18:08,655 WASHINGTON, D.C. AND THE FORMAT 1792 01:18:08,655 --> 01:18:09,656 WAS BASICALLY AFTER AN 1793 01:18:09,656 --> 01:18:11,224 INTRODUCTION AND A DISCUSSION ON 1794 01:18:11,224 --> 01:18:13,526 THE PROCESS, BASICALLY INVITED 1795 01:18:13,526 --> 01:18:15,228 SPEAKERS OR PRESENTERS WERE 1796 01:18:15,228 --> 01:18:16,763 GIVEN ABOUT TWENTY MINUTES TO 1797 01:18:16,763 --> 01:18:19,399 PITCH AN IDEA. AND MAYBE THEIR 1798 01:18:19,399 --> 01:18:20,767 IDEA, THEIR CURRENT RESEARCH OR 1799 01:18:20,767 --> 01:18:23,803 SOMETHING THEY THINK IS VERY 1800 01:18:23,803 --> 01:18:25,104 INTERESTING AND THEN IT'D BE 1801 01:18:25,104 --> 01:18:26,673 ABOUT 40 MINUTES FOR DISCUSSION 1802 01:18:26,673 --> 01:18:30,510 AMONG ALL THE PARTICIPANTS TO 1803 01:18:30,510 --> 01:18:33,346 HASH OUT BOTH THE FEASIBILITY OF 1804 01:18:33,346 --> 01:18:35,949 DOING RESEARCH IN THAT SPECIFIC 1805 01:18:35,949 --> 01:18:37,517 IDEA AS WELL AS IN IT REALLY 1806 01:18:37,517 --> 01:18:41,988 MADE ANY SENSE. THE LEADERSHIP 1807 01:18:41,988 --> 01:18:52,532 OF THIS MEETING WAS DR. PAUL Y., 1808 01:18:54,934 --> 01:18:57,337 MYSELF, AND DR. JILL AS A 1809 01:18:57,337 --> 01:19:02,141 MEDICAL WRITER. THESE ARE THE 1810 01:19:02,141 --> 01:19:03,977 ATTENDEES AND TOPICS THAT WERE 1811 01:19:03,977 --> 01:19:05,945 PRESENTED IN 10-15 MINUTES I 1812 01:19:05,945 --> 01:19:07,647 CAN'T GO THROUGH ALL OF THEM. I 1813 01:19:07,647 --> 01:19:08,815 AM GOING TO TALK ABOUT THE TOP 1814 01:19:08,815 --> 01:19:12,585 THREE THAT WERE DISCUSSED. BUT 1815 01:19:12,585 --> 01:19:16,055 THESE ARE SOME OF THE TOPICS AND 1816 01:19:16,055 --> 01:19:18,091 AT THE END OF THIS TALKLY GIVE 1817 01:19:18,091 --> 01:19:20,627 YOU A LINK TO THIS PRESENTATION 1818 01:19:20,627 --> 01:19:23,763 SO YOU CAN DIVE INTO ALL OF THE 1819 01:19:23,763 --> 01:19:28,268 AREAS THAT WERE DISCUSSED OR 1820 01:19:28,268 --> 01:19:37,577 PRESENTED IN MORE DEPTH. SO LET 1821 01:19:37,577 --> 01:19:39,178 ME TAKE A CHANCE TO LOOK AT ALL 1822 01:19:39,178 --> 01:19:39,779 THE PRESENTERS AND WHAT THEY 1823 01:19:39,779 --> 01:19:50,323 PRESENTED ON. SO WE IDENTIFIED 1824 01:19:52,025 --> 01:19:53,226 FIFTEEN POTENTIAL THERAPEUTICS 1825 01:19:53,226 --> 01:19:54,861 AND THESE ARE IN ALPHABETICAL 1826 01:19:54,861 --> 01:19:57,797 ORDER. THE ONES IN RED WERE THE 1827 01:19:57,797 --> 01:20:00,433 ONES THAT SEEM TO GET THE MOST 1828 01:20:00,433 --> 01:20:02,902 ATTENTION OR INTEREST AMONG THE 1829 01:20:02,902 --> 01:20:05,638 PARTICIPANTS. AND THE MOST 1830 01:20:05,638 --> 01:20:07,373 DISCUSSION. AND THEN AFTER THE 1831 01:20:07,373 --> 01:20:09,876 SUMMIT, THE ATTENDEES 1832 01:20:09,876 --> 01:20:13,012 ANONYMOUSLY RANKED THE FIFTEEN 1833 01:20:13,012 --> 01:20:15,782 MOST PROMISING -- RANKED THE 1834 01:20:15,782 --> 01:20:17,150 THERAPEUTICS. THEY RANKED THEM 1835 01:20:17,150 --> 01:20:18,918 FROM 1-15 IF THEY WANTED TO RANK 1836 01:20:18,918 --> 01:20:21,521 ALL OF THEM AND THESE ARE THE 1837 01:20:21,521 --> 01:20:22,956 ONES THAT RECEIVED -- THESE ARE 1838 01:20:22,956 --> 01:20:30,229 THE SCORES. AND SO WE CAN SEE 1839 01:20:30,229 --> 01:20:32,598 THIS WAS THE ONE THAT RECEIVED 1840 01:20:32,598 --> 01:20:37,003 THE MOST INTEREST FOLLOWED JUST 1841 01:20:37,003 --> 01:20:39,605 BEHIND BY ANOTHER TWO. I AM 1842 01:20:39,605 --> 01:20:44,610 GOING TO DISCUSS THESE THREE 1843 01:20:44,610 --> 01:20:54,454 TOPICS RIGHT NOW. KETOTY FEN 1844 01:20:54,454 --> 01:20:57,390 BLOCKS THE H 1 RECEPTOR AND 1845 01:20:57,390 --> 01:20:58,992 INHIBITS LEUCO TRY YEN FORMATION 1846 01:20:58,992 --> 01:21:01,561 IT'S FDA APPROVED BUT ORAL 1847 01:21:01,561 --> 01:21:03,396 MEDICATIONS ARE ONLY SDIS PENCED 1848 01:21:03,396 --> 01:21:06,065 DID I COMPOUND LG PHARMACIES, 1849 01:21:06,065 --> 01:21:08,501 THERE ARE TOPICAL EYE DROPS 1850 01:21:08,501 --> 01:21:08,801 AVAILABLE. 1851 01:21:08,801 --> 01:21:12,372 AND RECENTLY IN 2022, ANOTHER 1852 01:21:12,372 --> 01:21:15,008 EYE DROP WAS APPROVED. USING 1853 01:21:15,008 --> 01:21:18,911 THIS COMPOUND. BUT IT'S MAINLY 1854 01:21:18,911 --> 01:21:20,713 UTILIZED FOR ASTHMA. ANIMAL 1855 01:21:20,713 --> 01:21:23,449 STUDIES THAT WERE PRESENTED BY 1856 01:21:23,449 --> 01:21:25,585 DR. JACOB BORN SIXTEEN, HE 1857 01:21:25,585 --> 01:21:27,987 DISCUSSED AN ANIMAL MODEL THAT 1858 01:21:27,987 --> 01:21:29,122 IS QUITE WELL-KNOWN IN 1859 01:21:29,122 --> 01:21:31,557 VULVODYNIA THAT HAS BEEN DONE IN 1860 01:21:31,557 --> 01:21:35,995 BOTH ROW -- IN RATS AND MICE. 1861 01:21:35,995 --> 01:21:39,399 AND BASICALLY PSI KNOW SAN IS 1862 01:21:39,399 --> 01:21:41,367 INJECTED INTO THE VULVARS OF 1863 01:21:41,367 --> 01:21:44,470 THESE ANIMALS. AND WHAT THAT 1864 01:21:44,470 --> 01:21:50,910 DOES IS IT CAUSES INCREASED 1865 01:21:50,910 --> 01:21:53,346 MECHANICAL SENSE AT THIS TIME. 1866 01:21:53,346 --> 01:21:55,948 THERE'S INCREASED MAST CELLS AND 1867 01:21:55,948 --> 01:21:58,718 KNOW SEW CEPTORS THAT DEVELOP IN 1868 01:21:58,718 --> 01:22:01,454 THE VESTY BILES OF THESE ANIMALS 1869 01:22:01,454 --> 01:22:05,258 WHICH IS WHAT YOU FIND IN THE 1870 01:22:05,258 --> 01:22:09,095 PATHOLOGY OF WOMEN UNDERGOING 1871 01:22:09,095 --> 01:22:10,463 HAVE YOUS TIBIA YOU ELECTMY. SO 1872 01:22:10,463 --> 01:22:13,332 WHAT HAPPENED WAS IN THE SAMPLES 1873 01:22:13,332 --> 01:22:15,735 THAT WERE PRESENTED KETO FEW TEN 1874 01:22:15,735 --> 01:22:17,570 WAS PROTECTED PRIOR TO THE 1875 01:22:17,570 --> 01:22:21,874 CHALLENGE. AND THIS CAUSED A 1876 01:22:21,874 --> 01:22:28,514 VERY SIGNIFICANT REDUCTION IN 1877 01:22:28,514 --> 01:22:30,750 ALL THE INFLAMMATORY CYTOKINES 1878 01:22:30,750 --> 01:22:32,919 AS WELL AS A REDUCTION IN THE 1879 01:22:32,919 --> 01:22:36,022 MAST CELLS THAT WOULD ACCUMULATE 1880 01:22:36,022 --> 01:22:39,392 WITHOUT THE KE TOTY FEN. IT 1881 01:22:39,392 --> 01:22:48,868 PREVENTED HYPER INTNOVATION AND 1882 01:22:48,868 --> 01:22:55,174 REDUCEDTOTIFEN. IT 1883 01:22:55,174 --> 01:22:55,808 PREVENTED HYPER INNOVATION AND 1884 01:22:55,808 --> 01:22:57,543 REDUCED PAIN IN THE RATS. AS 1885 01:22:57,543 --> 01:23:03,783 WELL AS PAIN RELATED ANXIETY. 1886 01:23:03,783 --> 01:23:07,787 ADDITIONALLY, DR. BORN SIXTEEN'S 1887 01:23:07,787 --> 01:23:15,495 GROUP ALSO LOOKED AT THE SPINAL 1888 01:23:15,495 --> 01:23:18,297 CORD AND KETOTIFEN ALSO 1889 01:23:18,297 --> 01:23:20,466 SUPPRESSED GENE EXPRESSION IN 1890 01:23:20,466 --> 01:23:21,968 THE SPINAL CORD SO IT LOOKS LIKE 1891 01:23:21,968 --> 01:23:25,538 IT IS POSSIBLE NOT ONLY TO 1892 01:23:25,538 --> 01:23:28,741 PREVENT LOCAL AFFECT OF 1893 01:23:28,741 --> 01:23:30,476 INFLAMMATION SUCH AS FOR CHRONIC 1894 01:23:30,476 --> 01:23:34,113 YEAST INFECTIONS BUT INDEED MAY 1895 01:23:34,113 --> 01:23:39,218 BE ABLE TO PREVENT CENTRAL 1896 01:23:39,218 --> 01:23:45,391 SENSITIZATION BY PREVENT IING 1897 01:23:45,391 --> 01:23:48,861 INCREASED SENSITIZATION AT THIS 1898 01:23:48,861 --> 01:23:51,697 SYSTEM. THE SECOND RANKED AND 1899 01:23:51,697 --> 01:23:55,434 IT WAS A TIE WAS RESKINNY FER 1900 01:23:55,434 --> 01:23:58,871 RAH TOXIN AND THIS WAS PRESENTED 1901 01:23:58,871 --> 01:24:09,415 BY DR. MICHAEL WHO IS AT NIH AND 1902 01:24:10,483 --> 01:24:12,518 DEPARTMENT OF CARE. AND 1903 01:24:12,518 --> 01:24:15,388 BASICALLY WHAT HAPPENS IS THIS 1904 01:24:15,388 --> 01:24:20,993 BINDS TO THE TRPV 1 ION CHANNEL 1905 01:24:20,993 --> 01:24:23,796 CAUSING CALCIUM OVERLOAD AND 1906 01:24:23,796 --> 01:24:31,671 CAUSES THE -- CAUSES THE SAY TO 1907 01:24:31,671 --> 01:24:33,239 TOXICITY OF THE RECEPTOR AND 1908 01:24:33,239 --> 01:24:37,343 THAT CAUSES A HIGHLY SELECTED 1909 01:24:37,343 --> 01:24:40,580 CHEMO AX OTMY, BASICALLY DENEVER 1910 01:24:40,580 --> 01:24:44,584 VAGUS. NOW THIS RESKINNY FER 1911 01:24:44,584 --> 01:24:46,552 RAH TOXIN IS AN ANALOG OF 1912 01:24:46,552 --> 01:24:49,522 CAPSAICIN BUT IT IS FIVE HUNDRED 1913 01:24:49,522 --> 01:24:54,560 TIMES MORE THAN CAPSAICIN AND 1914 01:24:54,560 --> 01:24:56,829 THAT HAS BEEN USED AND RECENTLY 1915 01:24:56,829 --> 01:25:00,866 MY GROUP PUBLISHED ON USING 1916 01:25:00,866 --> 01:25:03,769 CAPSAICIN FOR VES TIBIA YOU DIN 1917 01:25:03,769 --> 01:25:05,438 YA BUT THIS HAS THE POSSIBILITY 1918 01:25:05,438 --> 01:25:09,108 OF BEING INJECTED LOCALLY. AND 1919 01:25:09,108 --> 01:25:14,280 CAUSING A DENEVER VAGUS OF THE 1920 01:25:14,280 --> 01:25:18,284 NOCICEPTORS IN WOMEN WHO HAVE 1921 01:25:18,284 --> 01:25:23,789 THIS. HE'S CURRENTLY STUDYING 1922 01:25:23,789 --> 01:25:26,058 THIS DRUG IN HIS GROUP. AND 1923 01:25:26,058 --> 01:25:29,929 WITH AN INCREASE IN NOCICEPTORS 1924 01:25:29,929 --> 01:25:32,732 WHICH MAY BE AKIN TO THIS. AND 1925 01:25:32,732 --> 01:25:35,167 WE'RE CURRENTLY -- THERE'S A 1926 01:25:35,167 --> 01:25:39,071 PROPOSAL FOR AN IN-HOUSE NIH 1927 01:25:39,071 --> 01:25:47,513 PHASE ONE STUDY OF THIS BY HIS 1928 01:25:47,513 --> 01:25:48,814 COLLEAGUES AT NIH AS WELL AS MY 1929 01:25:48,814 --> 01:25:59,358 COLLEAGUES. TIE FOR SECOND WAS 1930 01:26:06,565 --> 01:26:10,970 MA RAISIN. AND WIZ WAS TALKED 1931 01:26:10,970 --> 01:26:13,072 ABOUT IN THE UNIVERSITY OF 1932 01:26:13,072 --> 01:26:17,043 ROCHESTER. THIS IS A MEDIATOR. 1933 01:26:17,043 --> 01:26:20,346 SPMS WORKED WITH THE 1934 01:26:20,346 --> 01:26:21,047 POLYUNSATURATED FATTY ACIDS 1935 01:26:21,047 --> 01:26:23,916 WHICH PROMOTE THE RESOLUTION OF 1936 01:26:23,916 --> 01:26:25,318 INFLAMMATION. SPMS ARE 1937 01:26:25,318 --> 01:26:31,824 EFFECTIVE IN REDUCING IL-1 AND 1938 01:26:31,824 --> 01:26:36,529 PGE2. STUDIES OF VESTIBULAE DIN 1939 01:26:36,529 --> 01:26:43,569 YA SHOW SIGNIFICANTLY. AS WELL 1940 01:26:43,569 --> 01:26:45,204 AS INFILTRATES. NOT JUST MAST 1941 01:26:45,204 --> 01:26:48,808 CELLS BUT OTHER INFLAMMATORY 1942 01:26:48,808 --> 01:26:57,283 CELLS. AND SO IT IS POSSIBLE IF 1943 01:26:57,283 --> 01:26:59,819 WE CAN SHOW THE DECREASE IN 1944 01:26:59,819 --> 01:27:00,619 INFLAMMATION, WE CAN HELP 1945 01:27:00,619 --> 01:27:03,689 PREVENT THE ONSET OF VULVA DIN 1946 01:27:03,689 --> 01:27:06,592 YA OR POTENTIALLY TREAT 1947 01:27:06,592 --> 01:27:09,061 VULVODYNIA AND DR. F. PRESENTED 1948 01:27:09,061 --> 01:27:10,830 BOTH RODENT STUDIES USING THE 1949 01:27:10,830 --> 01:27:15,801 SAME MODEL THAT DR. BORNSTEIN 1950 01:27:15,801 --> 01:27:19,271 TALKED ABOUT. AS WELL AS 1951 01:27:19,271 --> 01:27:23,376 FIBROBLASTS RESEARCH AND THE 1952 01:27:23,376 --> 01:27:25,511 FIBROBLASTS FOR WOMEN WITH VES 1953 01:27:25,511 --> 01:27:27,146 TIBIA LOW DIN YA AND IF YOU ADD 1954 01:27:27,146 --> 01:27:30,116 THIS FIRST AND THEN INDUCED 1955 01:27:30,116 --> 01:27:33,219 INFLAMMATION EITHER IO 1 BETA 1956 01:27:33,219 --> 01:27:35,588 THEN THE MARIE SIN REDUCED BOTH 1957 01:27:35,588 --> 01:27:37,757 OF THESE INFLAMMATORY MEDIATORS 1958 01:27:37,757 --> 01:27:38,524 AND ALSO REDUCED PAIN 1959 01:27:38,524 --> 01:27:44,764 SIGNIFICANTLY. MAYBE MORE 1960 01:27:44,764 --> 01:27:49,935 EXCITEDLY IS THAT MARI SIN ALSO 1961 01:27:49,935 --> 01:27:51,804 WAS ABLE TO DECREASE 1962 01:27:51,804 --> 01:27:52,972 INFLAMMATION ONCE THE 1963 01:27:52,972 --> 01:27:56,008 INFLAMMATION HAD ALREADY 1964 01:27:56,008 --> 01:28:04,417 STARTED. THIS WAS ALSO 1965 01:28:04,417 --> 01:28:05,618 AFTERWARDS ONCE THE INFLAMMATION 1966 01:28:05,618 --> 01:28:09,054 HAD ALREADY OCCURRED THEN 1967 01:28:09,054 --> 01:28:11,424 TREATING WITH MA RAISIN 1968 01:28:11,424 --> 01:28:14,593 DECREASED BOTH PAIN AS WELL AS 1969 01:28:14,593 --> 01:28:20,966 INFLAMMATION SO THIS MAY ALSO BE 1970 01:28:20,966 --> 01:28:22,568 THE POSSIBILITY OF NOT ONLY 1971 01:28:22,568 --> 01:28:23,135 PREVENTING VIL BUT TREATING 1972 01:28:23,135 --> 01:28:25,671 VULVODYNIA. BECAUSE I DON'T 1973 01:28:25,671 --> 01:28:27,840 WANT -- I WANT TO GIVE FIVE 1974 01:28:27,840 --> 01:28:29,108 MINUTES FOR LECTURES I'M NOT 1975 01:28:29,108 --> 01:28:31,277 GOING TO GO INTO ALL THE OTHER 1976 01:28:31,277 --> 01:28:33,012 POTENTIAL THERAPEUTICS THAT WE 1977 01:28:33,012 --> 01:28:36,148 DID DISCUSS. AGAIN, WHAT I 1978 01:28:36,148 --> 01:28:40,953 WOULD LIKE TO DO IS GIVE YOU 1979 01:28:40,953 --> 01:28:42,788 JUST A LINK TO THIS PRESENTATION 1980 01:28:42,788 --> 01:28:44,557 AND I AM HAPPY TO SOMEWHERE 1981 01:28:44,557 --> 01:28:45,224 CONTAIN QUESTIONS NOW OR IN THE 1982 01:28:45,224 --> 01:28:50,529 FUTURE. THE GOAL AGAIN IS TO 1983 01:28:50,529 --> 01:28:58,103 PRODUCE A WHITE PAPER OR SIMILAR 1984 01:28:58,103 --> 01:28:59,238 PAPER ABOUT THIS. WE'RE IN THE 1985 01:28:59,238 --> 01:29:00,940 PROCESS OF MAKING THIS DOCUMENT 1986 01:29:00,940 --> 01:29:03,242 SO WE DON'T HAVE IT AVAILABLE 1987 01:29:03,242 --> 01:29:04,877 YET BUT WE HOPE TO BE MAKING IT 1988 01:29:04,877 --> 01:29:06,412 AVAILABLE IN THE COMING HERE 1989 01:29:06,412 --> 01:29:15,788 YEAR. THANK YOU. 1990 01:29:15,788 --> 01:29:18,390 >> THANK YOU SO MUCH THAT WAS A 1991 01:29:18,390 --> 01:29:20,826 SHARK TANK FOR THERAPEUTICS: 1992 01:29:20,826 --> 01:29:23,028 THAT WAS AN INCREDIBLE IDEA. I 1993 01:29:23,028 --> 01:29:24,363 HEARD YOU NEXT STEP IS THE WHITE 1994 01:29:24,363 --> 01:29:26,966 PAPER BY IN TERMS OF MOVING THAT 1995 01:29:26,966 --> 01:29:28,634 FORWARD WHAT ARE SOFT OTHER NEXT 1996 01:29:28,634 --> 01:29:31,637 STEPS SHOULD I TELL YOU THAT NIH 1997 01:29:31,637 --> 01:29:32,571 WOULD BE INTERESTED IN 1998 01:29:32,571 --> 01:29:34,640 APPLICATIONS IN THIS FIELD? 1999 01:29:34,640 --> 01:29:36,609 >> ABSOLUTELY, CERTAINLY 2000 01:29:36,609 --> 01:29:39,411 PARTICIPANTS, DR. AUN WAS VERY 2001 01:29:39,411 --> 01:29:41,347 KIND ENOUGH TO JOIN THIS SUMMIT 2002 01:29:41,347 --> 01:29:42,982 AND TALKED ABOUT ALL OF THE 2003 01:29:42,982 --> 01:29:47,620 FUNDING MECHANISMS THAT NIH HAS 2004 01:29:47,620 --> 01:29:50,689 FOR FUNDING FOR VULVODYNIA 2005 01:29:50,689 --> 01:29:53,325 UNFORTUNATELY, MANY RESEARCHERS 2006 01:29:53,325 --> 01:29:57,596 HAVE NOT TAKEN NIH UP ON THE 2007 01:29:57,596 --> 01:29:58,797 OPPORTUNITY SO IT'S FRUSTRATING 2008 01:29:58,797 --> 01:30:02,735 AND I -- AS I SAID EARLIER, 2009 01:30:02,735 --> 01:30:04,937 IT'S -- WE CAN ONLY -- BE 2010 01:30:04,937 --> 01:30:08,807 ENVIOUS OF WHAT'S GONE ON IN 2011 01:30:08,807 --> 01:30:10,943 ENDOMETRIOSIS RESEARCH COMPARED 2012 01:30:10,943 --> 01:30:12,545 TO VULVODYNIA RESEARCH. BUT AS 2013 01:30:12,545 --> 01:30:17,850 I JUST MENTIONED, IT LOOKS LIKE 2014 01:30:17,850 --> 01:30:21,387 AT LEAST SOME OF THE COMPOUNDS 2015 01:30:21,387 --> 01:30:24,490 AT LEAST THE TOP THREE THEY'RE 2016 01:30:24,490 --> 01:30:25,024 MOVING TOWARDS PHASE ONE 2017 01:30:25,024 --> 01:30:29,828 CLINICAL TRIALS BOTH THE MARI 2018 01:30:29,828 --> 01:30:31,330 SIN AND MAYBE A LITTLE MORE WORK 2019 01:30:31,330 --> 01:30:33,999 ON THE OTHER TWO. SINCE THAT'S 2020 01:30:33,999 --> 01:30:34,333 AVAILABLE. 2021 01:30:34,333 --> 01:30:35,467 WE WOULD ENCOURAGE ANY 2022 01:30:35,467 --> 01:30:40,205 RESEARCHERS OUT THERE TO TAKE 2023 01:30:40,205 --> 01:30:41,440 UP THAT CHALLENGE. IT LOOKS 2024 01:30:41,440 --> 01:30:44,910 LIKE A PROMISING TREATMENT. 2025 01:30:44,910 --> 01:30:46,679 POSSIBILITY. AND IT RANKED THE 2026 01:30:46,679 --> 01:30:49,582 MOST AMONG ALL THE RESEARCHERS 2027 01:30:49,582 --> 01:30:51,116 PRESENT YET. WE NEED SOMEONE TO 2028 01:30:51,116 --> 01:30:53,619 TAKE UP THAT MANTLE. 2029 01:30:53,619 --> 01:30:54,853 >> WONDERFUL. THERE'S A 2030 01:30:54,853 --> 01:30:56,855 QUESTION FOR YOU IN THE CHAT 2031 01:30:56,855 --> 01:30:59,124 BASED ON THESE NEW THERAPEUTICS 2032 01:30:59,124 --> 01:31:00,993 DO WE HAVE ANY INFORMATION ON 2033 01:31:00,993 --> 01:31:02,828 WHETHER -- WHAT THEIR PAIN 2034 01:31:02,828 --> 01:31:05,664 PROFILE IS IN TERMS OF ARE MAY 2035 01:31:05,664 --> 01:31:08,500 MORE OR LESS PAINFUL THAN 2036 01:31:08,500 --> 01:31:09,401 CAPSAICIN? 2037 01:31:09,401 --> 01:31:11,937 >> WELL THE -- SPECIFICALLY RAH 2038 01:31:11,937 --> 01:31:15,074 SIN FER ROW TOXIN WOULD BE 2039 01:31:15,074 --> 01:31:16,408 ADMINISTERED AFTER LOCAL 2040 01:31:16,408 --> 01:31:18,911 ANALGESIA SO AN INJECTION OF A 2041 01:31:18,911 --> 01:31:27,252 LOCAL ANESTHETIC. AND THIS LONG 2042 01:31:27,252 --> 01:31:29,488 ACTING. THE PAIN FROM RAH SIN 2043 01:31:29,488 --> 01:31:30,856 FER RAH TOXIN WOULD BE QUITE 2044 01:31:30,856 --> 01:31:32,992 INTENSE WITHOUT THIS INJECTION 2045 01:31:32,992 --> 01:31:36,061 OF THE LOCAL ANALGESIA. BUT 2046 01:31:36,061 --> 01:31:44,503 WITH THE INJECTION OF THE LOCAL 2047 01:31:44,503 --> 01:31:46,005 IT WILL LONG LASTER THAN THE 2048 01:31:46,005 --> 01:31:48,407 PAIN FROM THE RAH SIN KNOW FER 2049 01:31:48,407 --> 01:31:49,875 RAH TOXIN OR AT LEAST THAT'S 2050 01:31:49,875 --> 01:31:50,809 WHAT WE BELIEVE. 2051 01:31:50,809 --> 01:31:52,511 >> INTERESTING, THANK YOU. AND 2052 01:31:52,511 --> 01:31:53,812 THEN THERE'S A QUESTION ABOUT -- 2053 01:31:53,812 --> 01:31:55,781 DO WE KNOW ANYTHING ABOUT HOW 2054 01:31:55,781 --> 01:31:57,816 THESE THERAPEUTICS MIGHT MEASURE 2055 01:31:57,816 --> 01:31:59,785 AGAINST STANDARD OF CARE NOW 2056 01:31:59,785 --> 01:32:02,955 WHICH MIGHT INCLUDE TOPICAL 2057 01:32:02,955 --> 01:32:07,726 ESTROGEN OR OTHER HORMONAL 2058 01:32:07,726 --> 01:32:07,960 CREAMS? 2059 01:32:07,960 --> 01:32:08,994 >> I THINK THAT THE PROBLEM WE 2060 01:32:08,994 --> 01:32:10,029 HAVE WITH THE VULVODYNIA IS T 2061 01:32:10,029 --> 01:32:14,667 THAT, YOU KNOW, THIS IS A BIG 2062 01:32:14,667 --> 01:32:17,403 GROUP OF DIFFERENT DISORDERS 2063 01:32:17,403 --> 01:32:19,638 THAT WE ALL LUMP INTO VULVODYNIA 2064 01:32:19,638 --> 01:32:22,741 SO WHEREAS, TOPICAL HORMONES 2065 01:32:22,741 --> 01:32:25,411 CERTAINLY MAY BE VERY BENEFICIAL 2066 01:32:25,411 --> 01:32:27,780 AND HORMONALLY ASSOCIATED 2067 01:32:27,780 --> 01:32:31,250 VULVODYNIA. IT'S UNLIKELY TO BE 2068 01:32:31,250 --> 01:32:33,419 VERY, VERY USEFUL IN NEEDING ONE 2069 01:32:33,419 --> 01:32:36,588 THAT'S INFLAMMATORY OR NEURO 2070 01:32:36,588 --> 01:32:37,823 PROLIFERATIVE SO I THINK THAT 2071 01:32:37,823 --> 01:32:43,662 THE GOAL OF THE MOST RECENT VIL 2072 01:32:43,662 --> 01:32:48,834 NOMENCLATURE IS TO TRY TO BREAK 2073 01:32:48,834 --> 01:32:51,804 OUT SUBCATEGORIES OF VULVODYNIA. 2074 01:32:51,804 --> 01:32:54,840 AS WELL AS ASSOCIATED FACTORS OF 2075 01:32:54,840 --> 01:32:57,443 THE UNDERLYING HISTOPATHOLOGY 2076 01:32:57,443 --> 01:33:00,079 AGAINST SITINFLAMMATION OR 2077 01:33:00,079 --> 01:33:03,549 PROLIFERATION OR HORMONAL CAUSES 2078 01:33:03,549 --> 01:33:05,984 OR SECONDARY TO OVERACTIVE 2079 01:33:05,984 --> 01:33:08,153 PELVIC FLOOR MUSCLE DYSFUNCTION 2080 01:33:08,153 --> 01:33:10,089 AND THEN IN SO DOING, I THINK WE 2081 01:33:10,089 --> 01:33:13,225 CAN HONE OUR RESEARCH TO -- AND 2082 01:33:13,225 --> 01:33:15,327 THEREFORE I THINK WE'RE GOING TO 2083 01:33:15,327 --> 01:33:17,596 HAVE THE -- MUCH MORE SUCCESSFUL 2084 01:33:17,596 --> 01:33:20,299 IN FINDING A THERAPEUTICS. 2085 01:33:20,299 --> 01:33:23,836 BECAUSE THE TWO LARGE SCALE 2086 01:33:23,836 --> 01:33:26,004 FUNDED STUDIES FROM -- THAT WERE 2087 01:33:26,004 --> 01:33:31,477 FUNDED BY NIH BOTH IN GABAPENTIN 2088 01:33:31,477 --> 01:33:32,978 REALLY FAILED TO SHOW ANY 2089 01:33:32,978 --> 01:33:34,446 BENEFIT BUT THAT MAY HAVE BEEN 2090 01:33:34,446 --> 01:33:37,916 BECAUSE WE TOOK JUST ALL NUMBERS 2091 01:33:37,916 --> 01:33:39,818 OF PEOPLE WHO HAD VULVODYNIA AND 2092 01:33:39,818 --> 01:33:47,126 WE DIDN'T MAKE THE EFFORT TO THE 2093 01:33:47,126 --> 01:33:48,327 SUBCATEGORY OF THESE WYOMING I 2094 01:33:48,327 --> 01:33:49,762 THINK WE'RE MAYBE 20 YEARS 2095 01:33:49,762 --> 01:33:52,631 BEHIND SOME OF THE OTHER. 2096 01:33:52,631 --> 01:33:54,266 PELVIC PAIN FIELDS OR 2097 01:33:54,266 --> 01:33:55,367 GYNECOLOGIC PAIN FIELDS I THINK 2098 01:33:55,367 --> 01:33:56,935 WE'RE DOING OUR BEST TO CATCH UP 2099 01:33:56,935 --> 01:33:58,237 TO HELP THE WOMEN WHO SUFFER 2100 01:33:58,237 --> 01:34:05,477 FROM THIS PAIN. 2101 01:34:05,477 --> 01:34:07,780 >> THANK YOU IT SOUNDS LIKE LOTS 2102 01:34:07,780 --> 01:34:09,414 OF POSSIBILITIES TO CATCH UP. 2103 01:34:09,414 --> 01:34:11,884 IT SEEMS THERE ARE LOTS OF 2104 01:34:11,884 --> 01:34:13,585 PRESENTATION IN THE LINK. WE 2105 01:34:13,585 --> 01:34:15,954 WILL ASK YOU TO PUT THAT IN THE 2106 01:34:15,954 --> 01:34:18,290 Q&A OR THE LINK AND WE WILL SEND 2107 01:34:18,290 --> 01:34:20,626 IT OUT I AM SURE DR. AUN AT THE 2108 01:34:20,626 --> 01:34:23,829 END OF THIS MEETING WILL SEND 2109 01:34:23,829 --> 01:34:25,531 OUT LOTS OF INFORMATION TO 2110 01:34:25,531 --> 01:34:26,431 THOSE. THANK YOU SO MUCH FOR 2111 01:34:26,431 --> 01:34:27,065 PRESENTING THOSE REALLY EXCITING 2112 01:34:27,065 --> 01:34:28,934 OPTIONS. 2113 01:34:28,934 --> 01:34:30,135 >> AGAIN, THANKS FOR HAVING ME 2114 01:34:30,135 --> 01:34:31,904 I'M HAPPY TO ANSWER MORE 2115 01:34:31,904 --> 01:34:32,337 QUESTIONS BY E-MAIL. 2116 01:34:32,337 --> 01:34:35,808 >> THANK YOU. AND THEN I WILL 2117 01:34:35,808 --> 01:34:38,143 SAY WE'LL ASK THE DOCTOR TO 2118 01:34:38,143 --> 01:34:39,745 STICK AROUND AND ANSWER ANY IF 2119 01:34:39,745 --> 01:34:41,313 HE IS STILL AVAILABLE SO WE NOW 2120 01:34:41,313 --> 01:34:44,349 TURN VERY HAPPILY TO TOP PATIENT 2121 01:34:44,349 --> 01:34:45,484 ADVOCATES AND PATIENT 2122 01:34:45,484 --> 01:34:50,489 PERSPECTIVES. FOR REALLY 2123 01:34:50,489 --> 01:34:51,123 UNDERSTANDING A DIFFERENT POINT 2124 01:34:51,123 --> 01:34:52,224 OF VIEW OF THINGS AND WHAT'S 2125 01:34:52,224 --> 01:34:53,859 GOING ON IN THE ADVOCACY WORLD. 2126 01:34:53,859 --> 01:34:57,396 SO WE'RE GOING TO START WITH 2127 01:34:57,396 --> 01:34:59,464 REPRESENTATIVES FROM TIGHT 2128 01:34:59,464 --> 01:35:04,636 LIPPED WHICH IS A GRASSROOT 2129 01:35:04,636 --> 01:35:07,206 MOVEMENT CREATED BY PEOPLE WITH 2130 01:35:07,206 --> 01:35:08,473 PELVIC PAIN AND THE FIRST TO 2131 01:35:08,473 --> 01:35:09,808 SPEAK TO THAT WILL BE NOAH. I 2132 01:35:09,808 --> 01:35:10,909 WILL TURN IT OVER TO YOU. 2133 01:35:10,909 --> 01:35:12,678 >> GREAT, THANK YOU SO MUCH. 2134 01:35:12,678 --> 01:35:23,188 LET ME JUST SHARE MY SCREEN. 2135 01:35:24,122 --> 01:35:25,524 OKAY SO THANK YOU SO MUCH FOR 2136 01:35:25,524 --> 01:35:27,492 INVITING US AND FOR PUTTING 2137 01:35:27,492 --> 01:35:28,727 TOGETHER THIS CONFERENCE TODAY I 2138 01:35:28,727 --> 01:35:30,696 AM HERE REPRESENTING MANY 2139 01:35:30,696 --> 01:35:34,566 PATIENTS WITH CHRONIC AS A RULE 2140 01:35:34,566 --> 01:35:36,034 VOE VAGINAL AND PELVIC PAIN 2141 01:35:36,034 --> 01:35:37,769 CONDITIONS AND WE KNOW HOW 2142 01:35:37,769 --> 01:35:39,238 IMPORTANT IT IS FOR THERE TO BE 2143 01:35:39,238 --> 01:35:40,372 RESEARCH INTO ANY TREATMENTS, 2144 01:35:40,372 --> 01:35:42,441 INTO THE CAUSES AND BETTER 2145 01:35:42,441 --> 01:35:43,442 UNDERSTANDING OF WHAT CAUSES 2146 01:35:43,442 --> 01:35:44,610 THESE CONDITIONS AND HOW CONNECT 2147 01:35:44,610 --> 01:35:46,078 MORE EFFECTIVELY TREAT THEM SO 2148 01:35:46,078 --> 01:35:49,314 MY NAME IS NOAH, I'M THE 2149 01:35:49,314 --> 01:35:50,649 EXECUTIVE DIRECTOR OF TIGHT 2150 01:35:50,649 --> 01:35:52,284 LIPPED AND I WILL TALK ABOUT 2151 01:35:52,284 --> 01:35:52,951 BARRIER TO CARE AND ABOUT 2152 01:35:52,951 --> 01:35:54,887 PATIENT STORIES. SO I WANT TO 2153 01:35:54,887 --> 01:35:58,190 JUST SHARE VERY BRIEFLY A LITTLE 2154 01:35:58,190 --> 01:36:00,692 BIT ABOUT OUR ORGANIZATION. AS 2155 01:36:00,692 --> 01:36:02,694 CANDACE MENTIONED WE ARE A 2156 01:36:02,694 --> 01:36:04,062 GRASSROOTS ADVOCACY ORGANIZATION 2157 01:36:04,062 --> 01:36:06,665 AND WE ARE FOCUSED TO HELP 2158 01:36:06,665 --> 01:36:08,133 PATIENTS ACCESS THE CARE THAT 2159 01:36:08,133 --> 01:36:10,168 THEY NEED. WE HEARD FROM SO 2160 01:36:10,168 --> 01:36:11,670 MANY PEOPLE AND ALSO THIS IS 2161 01:36:11,670 --> 01:36:13,238 FOLLOWED WITH ALL THE STUDIES 2162 01:36:13,238 --> 01:36:15,007 THAT HAVE BEEN DONE ON THIS THAT 2163 01:36:15,007 --> 01:36:17,175 SO MANY PATIENTS WITH AS A RULE 2164 01:36:17,175 --> 01:36:18,410 VOE VAGINAL PAIN REALLY STRUGGLE 2165 01:36:18,410 --> 01:36:20,445 TO GET DIAGNOSED, GO YEARS 2166 01:36:20,445 --> 01:36:21,546 BEFORE GETTING DIAGNOSED AND 2167 01:36:21,546 --> 01:36:23,248 REALLY STRUGGLE TO FIND 2168 01:36:23,248 --> 01:36:25,350 EFFECTIVE TREATMENT I COME TO 2169 01:36:25,350 --> 01:36:29,988 THIS FROM MY OWN PERSPECTIVE AND 2170 01:36:29,988 --> 01:36:31,690 I KNOW FROM MY OWN PERSONAL 2171 01:36:31,690 --> 01:36:32,424 EXPERIENCE HOW DIFFICULT IT IS 2172 01:36:32,424 --> 01:36:33,959 TO GET DIAGNOSIS AND THE TREATED 2173 01:36:33,959 --> 01:36:35,294 FOR THESE CONDITIONS WHEN I 2174 01:36:35,294 --> 01:36:37,496 FIRST WENT TO MY GYNECOLOGIST 2175 01:36:37,496 --> 01:36:42,868 AND WAS IN SO MUCH PAIN I COULD 2176 01:36:42,868 --> 01:36:44,636 NOT TOLERATE TAMPONS, PELVIC 2177 01:36:44,636 --> 01:36:46,672 EXAMS MY GYNECOLOGIST SAID THAT 2178 01:36:46,672 --> 01:36:49,074 WAS JUST ANXIETY AND DID NOT 2179 01:36:49,074 --> 01:36:50,175 THINK THAT WAS A REAL MEDICAL 2180 01:36:50,175 --> 01:36:52,010 CONDITION AND PUT ME UNDER 2181 01:36:52,010 --> 01:36:54,813 GENERAL ANESTHESIA IN ORDER TO 2182 01:36:54,813 --> 01:36:56,882 TOLERATE MY PAP SMEAR AND SENT 2183 01:36:56,882 --> 01:36:59,184 ME HOME TO DIFFICULT IT ON MY 2184 01:36:59,184 --> 01:37:02,587 OWN SO I NOW HOW DIFFICULT IT IS 2185 01:37:02,587 --> 01:37:07,826 TO GET TREATED. WE STARTED AS A 2186 01:37:07,826 --> 01:37:08,493 PODCAST AND ALMOST IMMEDIATELY 2187 01:37:08,493 --> 01:37:10,262 AFTER LAUNCHING THE PODCAST WE 2188 01:37:10,262 --> 01:37:13,999 WERE FLOODED WITH STORIES FROM 2189 01:37:13,999 --> 01:37:16,568 PEOPLE ALL OVER THE WORLD 2190 01:37:16,568 --> 01:37:18,437 ESSENTIALLY TELLING US THE SAME 2191 01:37:18,437 --> 01:37:20,172 STORY OF HOW DIFFICULT IT WAS TO 2192 01:37:20,172 --> 01:37:22,307 DEAL WITH THE STIGMA AND HOW 2193 01:37:22,307 --> 01:37:23,275 DIFFICULT IT WAS FOR THEM TO BE 2194 01:37:23,275 --> 01:37:25,811 ABLE TO GET ACCURATE AND 2195 01:37:25,811 --> 01:37:28,080 ADEQUATE CARE. SO WE HAVE 2196 01:37:28,080 --> 01:37:29,247 EXPANDED BEYOND BEING A 2197 01:37:29,247 --> 01:37:32,818 STORYTELLING PROJECT, WE ARE AN 2198 01:37:32,818 --> 01:37:33,986 ADVOCACY ORGANIZATION AND WORK 2199 01:37:33,986 --> 01:37:35,320 IN COLLABORATION BETWEEN 2200 01:37:35,320 --> 01:37:37,422 PATIENTS AND MEDICAL PROVIDERS 2201 01:37:37,422 --> 01:37:38,523 WORKING TOWARDS A FUTURE WHERE 2202 01:37:38,523 --> 01:37:40,625 PATIENTS HAVE THE CARE THEY NEED 2203 01:37:40,625 --> 01:37:43,495 AND WHERE THERE IS NO STIGMA 2204 01:37:43,495 --> 01:37:44,396 ASSOCIATED WITH THESE 2205 01:37:44,396 --> 01:37:45,530 CONDITIONS. WE HAVE ACTIVE 2206 01:37:45,530 --> 01:37:46,999 CHAPTERS ACROSS THE COUNTRY. WE 2207 01:37:46,999 --> 01:37:48,600 ARE A NATIONAL ORGANIZATION. WE 2208 01:37:48,600 --> 01:37:52,070 HAVE CHAPTERS IN LOS ANGELES, 2209 01:37:52,070 --> 01:37:57,075 NEW YORK, CONNECTICUT, 2210 01:37:57,075 --> 01:37:59,211 PHILADELPHIA, ALL OF OUR 2211 01:37:59,211 --> 01:38:00,779 VOLUNTEERS HAVE A WHOLE RANGE OF 2212 01:38:00,779 --> 01:38:02,047 CONDITIONS. I WILL SHOW YOU A 2213 01:38:02,047 --> 01:38:05,517 LITTLE BIT OF BACKGROUND ON WHAT 2214 01:38:05,517 --> 01:38:07,586 CONDITIONS. SO WE'RE REALLY AN 2215 01:38:07,586 --> 01:38:08,320 UMBRELLA ORGANIZATION THAT 2216 01:38:08,320 --> 01:38:13,258 COVERS A NUMBER OF DIFFERENT 2217 01:38:13,258 --> 01:38:15,460 CONDITIONS THAT COVERS PELVIC 2218 01:38:15,460 --> 01:38:17,262 FLOOR PAIN. WE KNOW THERE'S A 2219 01:38:17,262 --> 01:38:20,565 VAST AMOUNT OF CONDITIONS, 2220 01:38:20,565 --> 01:38:24,002 VULVODYNIA, AND ALSO LICHEN SKER 2221 01:38:24,002 --> 01:38:26,405 LOW SUS AND A WE HAVE A 2222 01:38:26,405 --> 01:38:27,939 COMMUNITY NETWORK OF PEOPLE WHO 2223 01:38:27,939 --> 01:38:30,609 HAVE A WHOLE BUNCH OF 2224 01:38:30,609 --> 01:38:31,243 OVERLAPPING CONDITIONS AND WHO 2225 01:38:31,243 --> 01:38:33,045 ALSO COME TO US WITH ANY NUMBER 2226 01:38:33,045 --> 01:38:36,415 OF THESE SYMPTOMS AND 2227 01:38:36,415 --> 01:38:37,582 EXPERIENCES. AS WE KNOW THESE 2228 01:38:37,582 --> 01:38:40,018 CONDITIONS ARE SUPER, SUPER 2229 01:38:40,018 --> 01:38:40,619 COMMON EVEN THOUGH THEY'RE 2230 01:38:40,619 --> 01:38:44,256 REALLY STIGMATIZED, UP TO 28% OF 2231 01:38:44,256 --> 01:38:45,757 WOMEN IN THE UNITED STATES AND 2232 01:38:45,757 --> 01:38:47,859 WE KNOW IT'S NOT JUST WOMEN BUT 2233 01:38:47,859 --> 01:38:50,595 ALSO FOLKS WHO ARE NONBINARY, 2234 01:38:50,595 --> 01:38:52,597 TRANSGENDER, ANYONE CAN 2235 01:38:52,597 --> 01:38:54,266 EXPERIENCE CHRONIC AS A RULE VOE 2236 01:38:54,266 --> 01:38:56,134 VAGINAL AND CHRONIC PAIN AND 2237 01:38:56,134 --> 01:39:05,777 IT'S SUPER COMMON AND CHRONIC 2238 01:39:05,777 --> 01:39:07,112 CONDITION. WE WORK WITH 2239 01:39:07,112 --> 01:39:08,447 ABSOLUTELY GREAT MEDICAL 2240 01:39:08,447 --> 01:39:09,581 PROVIDERS. THESE ARE SOME OF 2241 01:39:09,581 --> 01:39:10,916 THE MEDICAL PROVIDERS THAT WE 2242 01:39:10,916 --> 01:39:14,319 WORK WITH. THIS IS THE ADVISORY 2243 01:39:14,319 --> 01:39:18,223 BOARD. OBGYN, VAGINAL PAIN 2244 01:39:18,223 --> 01:39:19,758 SPECIALIST, PHYSICAL THERAPISTS 2245 01:39:19,758 --> 01:39:22,160 AND SO MANY OTHERS WHO HAVE 2246 01:39:22,160 --> 01:39:22,727 DEDICATED THEIR LIVES AND 2247 01:39:22,727 --> 01:39:23,395 CAREERS TO TREATING PEOPLE WITH 2248 01:39:23,395 --> 01:39:27,299 THESE CONDITIONS. SO I'M GOING 2249 01:39:27,299 --> 01:39:29,134 TO PASS IT OVER TO KEENA WHO IS 2250 01:39:29,134 --> 01:39:30,936 HERE. KEENA IS THE CHAIR OF 2251 01:39:30,936 --> 01:39:33,672 OUR -- CO-CHAIR OF OUR LOS 2252 01:39:33,672 --> 01:39:35,774 ANGELES CHAPTER AND SHE WILL 2253 01:39:35,774 --> 01:39:37,309 SHARE ABOUT HER OWN PERSONAL 2254 01:39:37,309 --> 01:39:38,009 STORY AND EXPERIENCE BECAUSE SO 2255 01:39:38,009 --> 01:39:39,811 MUCH OF OUR WORK IS MOTIVATED BY 2256 01:39:39,811 --> 01:39:41,313 THE STORIES AND EXPERIENCES THAT 2257 01:39:41,313 --> 01:39:42,347 WE'VE HAD OURSELVES AND SO WE 2258 01:39:42,347 --> 01:39:44,716 WANT TO SHED A LITTLE BIT OF 2259 01:39:44,716 --> 01:39:45,817 LIGHT ON WHAT THAT HAS BEEN 2260 01:39:45,817 --> 01:39:46,118 LIKE. 2261 01:39:46,118 --> 01:39:47,819 >> THANK YOU, KNOW WASHGS THANK 2262 01:39:47,819 --> 01:39:50,188 YOU FOR PASSING IT OVER TO ME. 2263 01:39:50,188 --> 01:39:52,290 I WANTED TO START OFF BY 2264 01:39:52,290 --> 01:39:55,260 THANKING THE GHDB AND THE NICHD 2265 01:39:55,260 --> 01:39:57,462 AND THE NIH FOR HOST THING 2266 01:39:57,462 --> 01:39:59,731 EVENT. MY NAME IS KEENA, I'M 2267 01:39:59,731 --> 01:40:01,833 HONORED TO BE HERE AND HAVE A 2268 01:40:01,833 --> 01:40:03,368 FEW MINUTES TO SHARE MY STORY 2269 01:40:03,368 --> 01:40:04,736 WHILE MY EXPERIENCES DON'T 2270 01:40:04,736 --> 01:40:06,505 ENCOMPASS THAT OF EVERY PATIENT 2271 01:40:06,505 --> 01:40:08,940 I HOPE I CAN IMPART A SENSE OF 2272 01:40:08,940 --> 01:40:10,942 WHAT IT IS LIKE TO LIVE WITH 2273 01:40:10,942 --> 01:40:11,977 THESE PAIN CONDITIONS WHEN I WAS 2274 01:40:11,977 --> 01:40:14,179 19, I WANTED TO START TAKING 2275 01:40:14,179 --> 01:40:16,515 BIRTH CONTROL SO I VISITED MY 2276 01:40:16,515 --> 01:40:18,016 GYNECOLOGIST. AND HE CATALOGED 2277 01:40:18,016 --> 01:40:19,851 THE MANY WAYS BIRTH CONTROL 2278 01:40:19,851 --> 01:40:21,620 WOULD BENEFIT ME HE ALSO WORNED 2279 01:40:21,620 --> 01:40:24,556 ME OF BLOOD CLOTS BUT THAT WAS 2280 01:40:24,556 --> 01:40:26,892 ONLY THE SIDE EFFECT I WAS GIVEN 2281 01:40:26,892 --> 01:40:28,994 MANY IN MY OIMENT. I WAS MAKING 2282 01:40:28,994 --> 01:40:32,230 A DECISION TO TAKE A MEDICATION 2283 01:40:32,230 --> 01:40:33,698 THAT WOULD DRASTICALLY ALTER MY 2284 01:40:33,698 --> 01:40:36,434 LIFE. FAST FORWARD A FEW YEARS 2285 01:40:36,434 --> 01:40:38,203 ALL THROUGHOUT MY 20S I 2286 01:40:38,203 --> 01:40:42,440 EXPERIENCED UTISES I WAS TOLD I 2287 01:40:42,440 --> 01:40:46,444 WAS PRONE TO THEM, PRICED 2288 01:40:46,444 --> 01:40:47,312 ANTIBIOTICS AND NONE OF MY 2289 01:40:47,312 --> 01:40:49,648 DOCTORS INVESTIGATED FURTHER 2290 01:40:49,648 --> 01:40:52,317 THEN I WAS 28 I HAD A UTI THAT 2291 01:40:52,317 --> 01:40:54,953 WOULDN'T GO AWAY I TOOK 2292 01:40:54,953 --> 01:40:56,755 ANTIBIOTICS FOR MONTHS AND 2293 01:40:56,755 --> 01:40:59,224 DEVELOPED AN ALLERGY TO 2294 01:40:59,224 --> 01:41:02,460 AMOXACILLIN I WAS IN SUCH 2295 01:41:02,460 --> 01:41:03,862 EXCRUCIATING PAIN THAT GOING TO 2296 01:41:03,862 --> 01:41:06,631 WORK WAS TORTURE I COULDN'T USE 2297 01:41:06,631 --> 01:41:08,667 TAMPONS, WEAR PANTS OR HAVE SEX 2298 01:41:08,667 --> 01:41:10,135 NOT KNOWING WHERE ELSE TO GO I 2299 01:41:10,135 --> 01:41:12,237 EVENTUALLY FIND A UROLOGIST AND 2300 01:41:12,237 --> 01:41:13,738 SEXUAL MEDICINE SPECIALIST WHO 2301 01:41:13,738 --> 01:41:17,275 DIAGNOSED ME WITH HORMONALLY 2302 01:41:17,275 --> 01:41:20,111 MEDIATED VIS TIBIOFIBULAR DIN 2303 01:41:20,111 --> 01:41:23,248 YA. HE TOLD ME THESE HAD WORKED 2304 01:41:23,248 --> 01:41:26,318 IN MY VESTIBULE. THIS HORMONE 2305 01:41:26,318 --> 01:41:27,886 DEFICIENCY CAUSED MY TISSUES TO 2306 01:41:27,886 --> 01:41:29,554 BECOME THIN AND DAMAGED LEADING 2307 01:41:29,554 --> 01:41:32,591 TO ALL MY PAIN SYMPTOMS. I WAS 2308 01:41:32,591 --> 01:41:33,758 SHOCKED. WHY HADN'T I BEEN 2309 01:41:33,758 --> 01:41:35,794 WARNED OF THIS AS A POTENTIAL 2310 01:41:35,794 --> 01:41:37,295 SIDE EFFECT? WHEN I PUSHED MY 2311 01:41:37,295 --> 01:41:40,332 ANGER DOWN AND TOLD MYSELF TO BE 2312 01:41:40,332 --> 01:41:41,499 DWRATFUL FOR A DIAGNOSIS HOWEVER 2313 01:41:41,499 --> 01:41:43,768 THINGS DIDN'T GET EASIER FROM 2314 01:41:43,768 --> 01:41:44,002 THERE. 2315 01:41:44,002 --> 01:41:45,904 MY UREA ROLL GIST PRESCRIBED TWO 2316 01:41:45,904 --> 01:41:46,705 MEDICATIONS ESPECIALLY 2317 01:41:46,705 --> 01:41:49,407 COMPOUNDED TOPICAL ESTROGEN AND 2318 01:41:49,407 --> 01:41:51,176 TESTOSTERONE CREAM AND A 2319 01:41:51,176 --> 01:41:52,477 TESTOSTERONE JELL AND WARNED ME 2320 01:41:52,477 --> 01:41:54,379 THESE MEDICATIONS WERE 2321 01:41:54,379 --> 01:41:55,614 TECHNICALLY OFF LABEL BECAUSE 2322 01:41:55,614 --> 01:41:56,815 THEY HAD NOT BEEN STUDIED ENOUGH 2323 01:41:56,815 --> 01:41:58,917 IN FEMALE BODIES FOR THE FDA TO 2324 01:41:58,917 --> 01:42:00,218 APPROVE THIS MEDICATION FOR USE 2325 01:42:00,218 --> 01:42:01,786 IN PATIENTS WITH VULVAS THEY 2326 01:42:01,786 --> 01:42:03,955 WERE NOT COVERED BY INSURANCE 2327 01:42:03,955 --> 01:42:07,359 AND COST ME IN TOTAL ALMOST 250 2328 01:42:07,359 --> 01:42:09,394 DOLLARS. AGAIN, I PUSHED MY 2329 01:42:09,394 --> 01:42:11,329 ANGER DOWN AND TOLD MYSELF TO BE 2330 01:42:11,329 --> 01:42:13,365 GRATEFUL I COULD AFFORD MY 2331 01:42:13,365 --> 01:42:14,366 MEDICATIONS. I THOUGHT THIS 2332 01:42:14,366 --> 01:42:15,934 WOULD BE THE END OF IT BUT 2333 01:42:15,934 --> 01:42:23,041 THINGS DID NOT GET EASIER. I 2334 01:42:23,041 --> 01:42:26,111 DIDN'T TO MY MEDICATIONS AS 2335 01:42:26,111 --> 01:42:28,179 QUICK AS MY DOCTORS EXPECTED. 2336 01:42:28,179 --> 01:42:29,848 HOW LONG WOULD HEALING TAKE WITH 2337 01:42:29,848 --> 01:42:36,621 MY COMORBIDITICOMORBIDITIES. M 2338 01:42:36,621 --> 01:42:38,890 HAD NO ANSWERS. HOWEVER WE KNOW 2339 01:42:38,890 --> 01:42:41,393 AS MANY AS 50 MILLION PEOPLE IN 2340 01:42:41,393 --> 01:42:42,661 THE UNITED STATES HAVE AN 2341 01:42:42,661 --> 01:42:43,828 AUTOIMMUNE DISEASE AND PEOPLE 2342 01:42:43,828 --> 01:42:48,500 WITH VIL HAVE AN ARES MORE 2343 01:42:48,500 --> 01:42:50,235 LIKELY TO EXPERIENCE THEM. 2344 01:42:50,235 --> 01:42:51,069 AND WE KNOW THEY'LL EXPERIENCE 2345 01:42:51,069 --> 01:42:52,270 PAIN IN THEIR LIFETIME. 2346 01:42:52,270 --> 01:42:54,773 WHILE I FELT ISOLATED AND ALONE 2347 01:42:54,773 --> 01:42:56,975 IN DEALING WITH MY CONDITIONS I 2348 01:42:56,975 --> 01:42:58,343 KNEW THERE WERE LIKELY MANY MORE 2349 01:42:58,343 --> 01:43:00,912 PEOPLE OUT THERE WITH THE SAME 2350 01:43:00,912 --> 01:43:01,880 UNANSWERED QUESTIONS SO I 2351 01:43:01,880 --> 01:43:03,481 PURSUED TWO PROCEDURES. THE 2352 01:43:03,481 --> 01:43:05,150 FIRST A LASER TREATMENT TO HELP 2353 01:43:05,150 --> 01:43:06,918 WITH MY VAGINAL TISSUES, THE 2354 01:43:06,918 --> 01:43:09,521 SECOND, BOTOX INJECTIONS TO MY 2355 01:43:09,521 --> 01:43:11,690 PELVIC FLOOR MUSCLES WHICH WERE 2356 01:43:11,690 --> 01:43:13,425 TIGHT FROM A YEAR OF CONSTANT 2357 01:43:13,425 --> 01:43:15,794 PAIN AND CLENCHING THESE WERE 2358 01:43:15,794 --> 01:43:17,729 CONSIDERED COSMETIC PROCEDURES 2359 01:43:17,729 --> 01:43:19,964 AND WERE ONCE AGAIN OFF LABEL 2360 01:43:19,964 --> 01:43:22,334 USES BECAUSE THEY'D NOT BEEN 2361 01:43:22,334 --> 01:43:23,335 STUDIED ENOUGH IN FEMALE BODIES 2362 01:43:23,335 --> 01:43:25,737 THE TOTAL COST OF THESE 2363 01:43:25,737 --> 01:43:27,806 PROCEDURES WAS $7,000 THE 2364 01:43:27,806 --> 01:43:29,107 DECISION TO RECEIVE THESE 2365 01:43:29,107 --> 01:43:30,942 TREATMENTS WAS A HEAVYWEIGHT ON 2366 01:43:30,942 --> 01:43:32,744 MY SHOULDERS. I WAS WRACKED 2367 01:43:32,744 --> 01:43:34,045 WITH FEAR AND GUILT WHAT IF THEY 2368 01:43:34,045 --> 01:43:36,081 DIDN'T WORK? WHAT AN INCREDIBLE 2369 01:43:36,081 --> 01:43:40,018 FINANCIAL BIRD BURDEN I WAS TO 2370 01:43:40,018 --> 01:43:43,121 MY HUSBAND AND FAMILY. 2371 01:43:43,121 --> 01:43:45,957 MY INTERNET SEARCHES WERE 2372 01:43:45,957 --> 01:43:47,392 LACKING IN HARD EVIDENCE. 2373 01:43:47,392 --> 01:43:49,260 ULTIMATELY, I CHOSE TO TRUST MY 2374 01:43:49,260 --> 01:43:50,628 DOCTORS AND LUCKILY BOTH 2375 01:43:50,628 --> 01:43:52,364 TREATMENTS WERE INCREDIBLY 2376 01:43:52,364 --> 01:43:55,834 EFFECTIVE IN TREATING MY VULVA 2377 01:43:55,834 --> 01:43:57,769 VAGINAL AND PELVIC FLOOR PAIN. 2378 01:43:57,769 --> 01:44:01,773 IN MY ADVOCACY EFFORT WITH TIGHT 2379 01:44:01,773 --> 01:44:03,508 LIPPED I WORKED WITH ADMIRABLE 2380 01:44:03,508 --> 01:44:04,876 DOCTORS WHO ARE DOING THEIR BEST 2381 01:44:04,876 --> 01:44:06,644 THROUGH THEM I LEARN THAT HAD WE 2382 01:44:06,644 --> 01:44:08,513 KNOW THERE ARE GENETIC MARKERS 2383 01:44:08,513 --> 01:44:10,382 FOR PEOPLE LIKE ME. 2384 01:44:10,382 --> 01:44:11,950 PEOPLE WHO COULD DEVELOP THIS 2385 01:44:11,950 --> 01:44:13,985 FROM ORAL CONTRACEPTIVES WITH 2386 01:44:13,985 --> 01:44:15,186 PROPER RESEARCH AND FUND THING 2387 01:44:15,186 --> 01:44:18,022 COULD BE DEVELOPED INTO A TEST 2388 01:44:18,022 --> 01:44:21,493 AND BE GIVEN PRIOR TO BEING 2389 01:44:21,493 --> 01:44:23,128 PRESCRIBED BIRTH CONTROL. IT 2390 01:44:23,128 --> 01:44:24,829 PAINS ME THAT THIS TEST WILL 2391 01:44:24,829 --> 01:44:27,232 PROBABLY NEVER SEE THE LIGHT OF 2392 01:44:27,232 --> 01:44:29,033 DAY BECAUSE OF LACK OF FUNDING. 2393 01:44:29,033 --> 01:44:32,103 IT PAINS ME THAT I COULD HAVE 2394 01:44:32,103 --> 01:44:33,438 NOT HAD PAIN BECAUSE OF THE LACK 2395 01:44:33,438 --> 01:44:35,640 OF A TEST. IT FRUSTRATES ME 2396 01:44:35,640 --> 01:44:37,308 THAT THERE'S A MISCONCEPTION 2397 01:44:37,308 --> 01:44:39,110 THAT MY DIAGNOSIS IS RARE WHEN 2398 01:44:39,110 --> 01:44:40,912 IN REALITY WE SIMPLY JUST DON'T 2399 01:44:40,912 --> 01:44:42,046 KNOW HOW MANY PEOPLE THIS 2400 01:44:42,046 --> 01:44:43,648 CONDITION AFFECTS. IT HAS BEEN 2401 01:44:43,648 --> 01:44:46,184 FIVE YEARS SINCE I FIRST 2402 01:44:46,184 --> 01:44:47,819 EXPERIENCED VULVAR VAGINAL PAIN 2403 01:44:47,819 --> 01:44:51,322 AND I STILL AM NOT PAIN-FREE. 2404 01:44:51,322 --> 01:44:53,391 I COULD TELL YOU MY HEALTH 2405 01:44:53,391 --> 01:44:55,493 JOURNEY AND ALL THE DEAD ENDS WE 2406 01:44:55,493 --> 01:44:57,529 HAVE REACHED BECAUSE THERE IS NO 2407 01:44:57,529 --> 01:44:58,563 DATA. I COULD KEEP TELLING YOU 2408 01:44:58,563 --> 01:45:00,231 ABOUT ALL THE PROCEDURES I PAID 2409 01:45:00,231 --> 01:45:02,167 FOR OUT OF POCKET BECAUSE THERE 2410 01:45:02,167 --> 01:45:04,869 NO DATA TO FORCE THE HAND OF 2411 01:45:04,869 --> 01:45:06,704 INSURANCE TO COVER THEM. I 2412 01:45:06,704 --> 01:45:08,440 COULD WALK YOU THROUGH THE 2413 01:45:08,440 --> 01:45:09,607 COUNTLESS DISCUSSION I'VE HAD 2414 01:45:09,607 --> 01:45:12,377 WITH MY HUSBAND. WHAT TREATMENT 2415 01:45:12,377 --> 01:45:15,814 SHOULD WE SPEND THOUSANDS OF 2416 01:45:15,814 --> 01:45:20,785 DOLLARS ON. I COULD TALK ABOUT 2417 01:45:20,785 --> 01:45:22,921 WHAT'S WORSE, THE FEAR OF MAKING 2418 01:45:22,921 --> 01:45:26,324 THE WRONG GAMBLE OR THE 2419 01:45:26,324 --> 01:45:26,758 CONTINUED DEEPENING 2420 01:45:26,758 --> 01:45:28,593 CLAUSTROPHOBIA OR TAKING NO 2421 01:45:28,593 --> 01:45:30,528 ACTION AND KNOWING THAT ONLY 2422 01:45:30,528 --> 01:45:31,796 ASSURES MORE PAIN AND THE 2423 01:45:31,796 --> 01:45:34,065 CRUMBLING OF MY QUALITY OF LIFE 2424 01:45:34,065 --> 01:45:35,834 BY THAT WOULD TAKE HOURS AND WE 2425 01:45:35,834 --> 01:45:37,035 ONLY HAVE FIFTEEN MINUTES SO I 2426 01:45:37,035 --> 01:45:39,537 WILL LEAVE YOU WITH THIS IT IS 2427 01:45:39,537 --> 01:45:40,605 ABSOLUTELY TERRIFYING TO BE A 2428 01:45:40,605 --> 01:45:42,240 PATIENT WITH ACCESS AND 2429 01:45:42,240 --> 01:45:43,208 PRIVILEGE WORKING WITH DOCTORS 2430 01:45:43,208 --> 01:45:45,143 WHO ARE THE BEST IN THEIR FIELD 2431 01:45:45,143 --> 01:45:47,645 AND BEING TOLD WE JUST DON'T 2432 01:45:47,645 --> 01:45:50,014 KNOW ENOUGH AT EVERY TURN. 2433 01:45:50,014 --> 01:45:50,815 THANK YOU FOR YOUR TIME. AND 2434 01:45:50,815 --> 01:45:58,423 BACK OVER TO NOAH. 2435 01:45:58,423 --> 01:45:59,591 >> THANK YOU SO MUCH FOR SHARING 2436 01:45:59,591 --> 01:46:01,326 YOUR STORY. UNFORTUNATELY, 2437 01:46:01,326 --> 01:46:03,027 KEENA'S STORY IS AN EXTREMELY 2438 01:46:03,027 --> 01:46:05,096 COMMON STORY, EVERYDAY WE GET 2439 01:46:05,096 --> 01:46:05,763 MESSAGING FROM PATIENTS ACROSS 2440 01:46:05,763 --> 01:46:09,667 THE COUNTRY SHARING ABOUT THEIR 2441 01:46:09,667 --> 01:46:12,136 EXPERIENCES AND THE AMOUNT OF OF 2442 01:46:12,136 --> 01:46:13,671 MONEY TIME, THEY'VE HAD TO SPENT 2443 01:46:13,671 --> 01:46:15,507 WITH TRIAL AND ERROR OF 2444 01:46:15,507 --> 01:46:16,908 TREATMENTS I'M IN AND OUT GOING 2445 01:46:16,908 --> 01:46:18,810 TO GO INTO ALL THE DIFFERENT 2446 01:46:18,810 --> 01:46:19,811 BARRIER TO CARE BUT I WANT TO 2447 01:46:19,811 --> 01:46:21,579 HIGHLIGHT A COUPLE OF THINGS 2448 01:46:21,579 --> 01:46:23,581 FROM KEENA'S EXPERIENCE ONE IS 2449 01:46:23,581 --> 01:46:25,583 STIGMA. STIGMA IS A HUGE 2450 01:46:25,583 --> 01:46:26,784 BARRIER TO CARE THE FACT THAT WE 2451 01:46:26,784 --> 01:46:28,353 DON'T TALK ABOUT THESE 2452 01:46:28,353 --> 01:46:29,020 CONDITIONS, THAT THEY DON'T 2453 01:46:29,020 --> 01:46:30,488 RECEIVE THE RECOGNITION AND THE 2454 01:46:30,488 --> 01:46:32,390 FUNDING THAT THEY DESERVE AND 2455 01:46:32,390 --> 01:46:35,627 THAT MANY PATIENTS ARE OFTEN 2456 01:46:35,627 --> 01:46:37,428 DISMISSED AND THEIR INITIAL 2457 01:46:37,428 --> 01:46:38,596 SYMPTOMS ARE U SEEN AS THINGS 2458 01:46:38,596 --> 01:46:40,932 THAT ARE PSYCHOLOGICAL, 2459 01:46:40,932 --> 01:46:42,967 PSYCHOSOMATIC AND NOT WORTHY OR 2460 01:46:42,967 --> 01:46:44,269 IN NEED OF MEDICAL CARE THE 2461 01:46:44,269 --> 01:46:45,904 SECOND ONE I WANT TO HIGHLIGHT 2462 01:46:45,904 --> 01:46:49,040 IS LACK OF EDUCATION AND MEDICAL 2463 01:46:49,040 --> 01:46:51,142 KNOWLEDGE. MOST PATIENTS 2464 01:46:51,142 --> 01:46:54,412 STRUGGLE TO FIND A PROVIDER THAT 2465 01:46:54,412 --> 01:46:56,648 CAN DIAGNOSE THEM, TREAT THEM 2466 01:46:56,648 --> 01:46:59,083 AND MANY PATIENTS HAVE TO PAY 2467 01:46:59,083 --> 01:47:01,786 HUGE AMOUNTS OF MONEY TO FIND 2468 01:47:01,786 --> 01:47:04,188 SOMEONE OR FLY TO ANOTHER CITY 2469 01:47:04,188 --> 01:47:06,024 OR STATE TO FIND SOMEONE WITH A 2470 01:47:06,024 --> 01:47:08,159 BACKGROUND ON THIS. THE THIRD 2471 01:47:08,159 --> 01:47:09,093 ISSUE WHY WE'RE ALL HERE TODAY 2472 01:47:09,093 --> 01:47:12,096 IS LACK OF RESEARCH. THERE ARE 2473 01:47:12,096 --> 01:47:13,431 NOT ENOUGH TREATMENTS THAT ARE 2474 01:47:13,431 --> 01:47:14,966 WELL RESEARCHED FOR THESE 2475 01:47:14,966 --> 01:47:15,800 CONDITIONS AND MANY TREATMENTS 2476 01:47:15,800 --> 01:47:19,270 ARE TRIAL AND ERROR. AND AREN'T 2477 01:47:19,270 --> 01:47:20,538 ACTUALLY PROVEN TO BE EFFECTIVE 2478 01:47:20,538 --> 01:47:22,407 OR WE DON'T KNOW YET IF THEY ARE 2479 01:47:22,407 --> 01:47:24,208 EFFECTIVE AND INSURANCE AND 2480 01:47:24,208 --> 01:47:26,844 ACCESS TO CARE. MANY PATIENTS, 2481 01:47:26,844 --> 01:47:28,613 WHEN THEY DO FIND SOMETHING THAT 2482 01:47:28,613 --> 01:47:29,948 IT ACTUALLY WORKS FOR THEIR PAIN 2483 01:47:29,948 --> 01:47:33,818 IS NOT COVERED BY INSURANCE. IN 2484 01:47:33,818 --> 01:47:35,186 PART BECAUSE THERE ISN'T DATA 2485 01:47:35,186 --> 01:47:36,654 AND EVIDENCE BUT ALSO IN PART 2486 01:47:36,654 --> 01:47:38,623 BECAUSE INSURANCE DOESN'T COVER 2487 01:47:38,623 --> 01:47:39,691 THIS AS AN ESSENTIAL HEALTH 2488 01:47:39,691 --> 01:47:41,492 BENEFIT AND ALL OF THESE THINGS 2489 01:47:41,492 --> 01:47:42,994 PLAY INTO EACH OTHER. I WANT TO 2490 01:47:42,994 --> 01:47:45,263 LEAVE YOU WITH ONE THING WHICH 2491 01:47:45,263 --> 01:47:47,265 IS THAT AS A PATIENT-LED 2492 01:47:47,265 --> 01:47:48,866 ORGANIZATION, WE WROTE A 2493 01:47:48,866 --> 01:47:53,104 PETITION, A LETTER, WHEN THE WHO 2494 01:47:53,104 --> 01:47:55,540 IS WHITE HOUSE ANNOUNCED THE 2495 01:47:55,540 --> 01:47:57,108 INITIATIVE. 2496 01:47:57,108 --> 01:47:59,577 WITHIN A COUPLE DAYS WE HAD 835 2497 01:47:59,577 --> 01:48:01,512 PATIENTS WHO ARE WILLING TO SIGN 2498 01:48:01,512 --> 01:48:02,780 THEIR NAMES AND IDENTIFY 2499 01:48:02,780 --> 01:48:03,781 THEMSELVES WITH THEIR CONDITION 2500 01:48:03,781 --> 01:48:05,917 AND SAY I AM WILLING TO PUSH 2501 01:48:05,917 --> 01:48:07,619 PASS THE STIGMA AND SAY I HAVE 2502 01:48:07,619 --> 01:48:08,820 THE CONDITION IN ORDER TO PUT MY 2503 01:48:08,820 --> 01:48:12,090 VOICE OUT THERE AND TO SAY HOW 2504 01:48:12,090 --> 01:48:13,191 IMPORTANT IT IS FOR THERE TO BE 2505 01:48:13,191 --> 01:48:15,793 MORE INVESTMENT IN STUDYING NEW 2506 01:48:15,793 --> 01:48:18,429 TREATMENTS AND RESEARCH. THE 2507 01:48:18,429 --> 01:48:19,297 STATEMENTS THAT PEOPLE WROTE 2508 01:48:19,297 --> 01:48:20,598 WHEN THEY KIND OF TESTIFIED FOR 2509 01:48:20,598 --> 01:48:23,401 WHY THEY WERE SIGNING ONTO THIS 2510 01:48:23,401 --> 01:48:25,803 LETTER WERE INCREDIBLY 2511 01:48:25,803 --> 01:48:26,604 HEARTBREAKING AND MOVING. 2512 01:48:26,604 --> 01:48:28,172 PEOPLE TELLING US THEY'VE BEEN 2513 01:48:28,172 --> 01:48:29,807 STRUGGLING WITH THESE CONDITIONS 2514 01:48:29,807 --> 01:48:30,742 FOR YEARS AND WHAT IMPACT THAT 2515 01:48:30,742 --> 01:48:34,278 HAD HAD ON THEIR LIVES. WE HAVE 2516 01:48:34,278 --> 01:48:36,314 ACTUALLY A 30 PAGE DOCUMENT OF 2517 01:48:36,314 --> 01:48:37,015 TESTIMONIES WHEN WE ASKED PEOPLE 2518 01:48:37,015 --> 01:48:39,884 WHY ARE YOU SIGNING ON. THEY 2519 01:48:39,884 --> 01:48:41,786 SUBMITTED STORY AFTER STORY OF 2520 01:48:41,786 --> 01:48:42,820 TESTIMONY AFTER TESTIMONY OF HOW 2521 01:48:42,820 --> 01:48:44,756 IMPORTANT IT IS FOR THEM THAT 2522 01:48:44,756 --> 01:48:46,257 THERE'S MORE RESEARCH AND AN 2523 01:48:46,257 --> 01:48:48,426 INVESTMENT IN STUDYING THESE 2524 01:48:48,426 --> 01:48:49,794 CONDITIONS. AND THE NUMBER OF 2525 01:48:49,794 --> 01:48:50,795 TESTIMONIES WE RECEIVED 2526 01:48:50,795 --> 01:48:52,230 LITERALLY FILLED 30 PAGES AND I 2527 01:48:52,230 --> 01:48:54,332 AM HAPPY TO SHARE THOSE 2528 01:48:54,332 --> 01:48:57,468 TESTIMONIES WITH ANYONE WHO IS 2529 01:48:57,468 --> 01:48:59,303 INTERESTED. SO I NOW WE ONLY 2530 01:48:59,303 --> 01:49:00,638 HAVE A MINUTE LEFT IF PEOPLE 2531 01:49:00,638 --> 01:49:02,974 HAVE QUESTIONS AND WE ARE SO 2532 01:49:02,974 --> 01:49:04,509 APPRECIATIVE TO BE HERE TODAY 2533 01:49:04,509 --> 01:49:05,710 AND TO SEE THAT TOGETHER 2534 01:49:05,710 --> 01:49:06,878 PATIENTS AND RESEARCHERS ARE 2535 01:49:06,878 --> 01:49:13,584 REALLY TRYING TO INVEST IN 2536 01:49:13,584 --> 01:49:14,352 RESEARCHING THESE CONDITIONS. 2537 01:49:14,352 --> 01:49:15,653 I'M HAPPY TO ANSWER ANY 2538 01:49:15,653 --> 01:49:17,722 QUESTIONS IN THE Q&A AND ALSO 2539 01:49:17,722 --> 01:49:19,090 CONTINUE AFTER THE SESSION IF 2540 01:49:19,090 --> 01:49:20,258 PEOPLE HAVE QUESTIONS THAT THEY 2541 01:49:20,258 --> 01:49:27,832 WANT TO SEND OVER E-MAIL. 2542 01:49:27,832 --> 01:49:30,334 >> THANK YOU, NOA AND KEENA, I 2543 01:49:30,334 --> 01:49:32,303 HOPE YOU SEE THE REACTIONS IN 2544 01:49:32,303 --> 01:49:33,905 YOUR AUDIENCE WHO ARE COMPLETELY 2545 01:49:33,905 --> 01:49:36,074 MOVED BY YOUR STORIES. I THINK 2546 01:49:36,074 --> 01:49:37,675 NOTHING BETTER DEMONSTRATES WHY 2547 01:49:37,675 --> 01:49:40,511 WE SUPPORT THIS RESEARCH AND WHY 2548 01:49:40,511 --> 01:49:41,446 EVEN MORE IS NECESSARY THAN 2549 01:49:41,446 --> 01:49:42,280 HEARING SOME OF THE SUFFERING 2550 01:49:42,280 --> 01:49:43,347 AND I THINK IT'S HELPFUL FOR 2551 01:49:43,347 --> 01:49:45,083 ANYBODY IN OUR AUDIENCE TO HEAR 2552 01:49:45,083 --> 01:49:47,585 SOME OF THE SPECIFICS OF WHAT, 2553 01:49:47,585 --> 01:49:49,087 YOU KNOW, SOME PEOPLE FEEL 2554 01:49:49,087 --> 01:49:51,089 BECAUSE THEY MIGHT FEEL ALONE IN 2555 01:49:51,089 --> 01:49:53,758 THEIR EXPERIENCES. SO THAT'S 2556 01:49:53,758 --> 01:49:55,760 INCREDIBLE I JUST WANT TO SAY, 2557 01:49:55,760 --> 01:49:58,296 IF SOMEONE HAS QUESTIONS ON 2558 01:49:58,296 --> 01:49:59,797 CLINICIANS OR QUESTIONS FOR THE 2559 01:49:59,797 --> 01:50:01,966 COMMUNITY OR THINGS LIKE THAT, 2560 01:50:01,966 --> 01:50:04,969 IS THAT SOMETHING THEY COULD 2561 01:50:04,969 --> 01:50:06,471 ACCESS THROUGH YOUR GROUP? 2562 01:50:06,471 --> 01:50:08,539 >> YES, WE HAVE A SPREADSHEET 2563 01:50:08,539 --> 01:50:10,475 THAT -- THERE'S SOME AMAZING 2564 01:50:10,475 --> 01:50:11,309 RESOURCES OUT THERE AND WE HAVE 2565 01:50:11,309 --> 01:50:13,511 A SPREADSHEET THAT COMPILES ALL 2566 01:50:13,511 --> 01:50:15,546 THE DATABASES FOR FINDING A 2567 01:50:15,546 --> 01:50:17,882 CLINICIAN IN YOUR AREA AND OTHER 2568 01:50:17,882 --> 01:50:18,816 REPUTABLE MEDICAL RESOURCES AND 2569 01:50:18,816 --> 01:50:20,351 I WILL SHARE THE LINK TO THAT 2570 01:50:20,351 --> 01:50:21,552 RIGHT NOW IN THE CHAT. 2571 01:50:21,552 --> 01:50:22,920 >> PERFECT, THANK YOU SO MUCH. 2572 01:50:22,920 --> 01:50:24,355 SO WE DO NEED TO MOVE ON BUT I 2573 01:50:24,355 --> 01:50:25,623 AM SURE THERE'LL BE QUESTIONS 2574 01:50:25,623 --> 01:50:29,127 THAT POP UP FOR YOU BOTH AND IF 2575 01:50:29,127 --> 01:50:30,561 THE AUDIENCE WANTS TO PUT THOSE 2576 01:50:30,561 --> 01:50:35,566 IN THE Q&A I WILL ASK NOA AND 2577 01:50:35,566 --> 01:50:37,335 KEENA TO STAY ON THE Q&A AND 2578 01:50:37,335 --> 01:50:44,075 ANSWER THOF SMOEZ SOME OF THOSE 2579 01:50:44,075 --> 01:50:45,409 QUESTIONS IF THEY ARISE. LAST 2580 01:50:45,409 --> 01:50:49,714 IN THE SESSION WE WILL TURN IT 2581 01:50:49,714 --> 01:50:55,186 OVER TO DR. SUSAN WHO IS THE 2582 01:50:55,186 --> 01:50:56,754 DIRECTOR OF FEMALE SEXUAL 2583 01:50:56,754 --> 01:50:57,755 MEDICINE AND IS HERE 2584 01:50:57,755 --> 01:50:59,824 REPRESENTING THE NATIONAL 2585 01:50:59,824 --> 01:51:01,159 VULVODYNIA ASSOCIATION WHICH IS 2586 01:51:01,159 --> 01:51:02,393 ANOTHER ADVOCACY COMMUNITY WHO 2587 01:51:02,393 --> 01:51:04,595 IS WORKING TO IMPROVE RESEARCH 2588 01:51:04,595 --> 01:51:06,998 AND COMMUNITY IN THE FIELD OF 2589 01:51:06,998 --> 01:51:07,999 VULVODYNIA. SO I WILL TURN IT 2590 01:51:07,999 --> 01:51:11,169 OTHER TO YOU DR. SPADT. 2591 01:51:12,603 --> 01:51:14,505 THE HEALTH AND QUALITY OF LIFE OF 2592 01:51:14,505 --> 01:51:16,474 WOMEN SIFRING FROM CHRONIC 2593 01:51:16,474 --> 01:51:17,475 VULVAR PAIN. 2594 01:51:17,475 --> 01:51:19,710 THE MISSION FROM THE NATIONAL 2595 01:51:19,710 --> 01:51:20,645 VULVODYNIA ASSOCIATION WAS TO 2596 01:51:20,645 --> 01:51:22,346 PROVIDE UP-TO-DATE TREATMENT AND 2597 01:51:22,346 --> 01:51:24,148 RESEARCH INFORMATION SO PATIENTS 2598 01:51:24,148 --> 01:51:26,918 COULD MAKE DECISIONS ABOUT THEIR 2599 01:51:26,918 --> 01:51:31,122 CARE TO MAINTAIN A NATIONWIDE 2600 01:51:31,122 --> 01:51:36,627 REFERRAL OF OBGYNS TO HELP TREAT 2601 01:51:36,627 --> 01:51:38,863 VULVODYNIA AND FUND RESEARCH ON 2602 01:51:38,863 --> 01:51:41,465 THE PATH TROE FIZZ AND TREATMENT 2603 01:51:41,465 --> 01:51:44,168 OF VULVODYNIA. NEXT SLIDE, 2604 01:51:44,168 --> 01:51:44,402 PLEASE. 2605 01:51:44,402 --> 01:51:48,206 THE ISS VD CLASSIFICATION OF 2606 01:51:48,206 --> 01:51:50,107 VULVODYNIA IS THAT VULVODYNIA IS 2607 01:51:50,107 --> 01:51:51,609 VULVAR PAIN OF AT LEAST THREE 2608 01:51:51,609 --> 01:51:53,578 MONTHS DURATION WITHOUT A CLEAR 2609 01:51:53,578 --> 01:51:54,278 IDENTIFIABLE CAUSE WHICH MAY 2610 01:51:54,278 --> 01:51:56,347 HAVE A POTENTIAL ASSOCIATED 2611 01:51:56,347 --> 01:51:57,882 FACTORS AND IT MIGHT BE 2612 01:51:57,882 --> 01:51:59,784 GENERALIZED WITH MULTIPLE AREAS 2613 01:51:59,784 --> 01:52:02,053 OF THE VULVA AFFECTED OR 2614 01:52:02,053 --> 01:52:05,523 LOCALIZED WITH ONE AREA LIKE THE 2615 01:52:05,523 --> 01:52:06,757 CLITORIS, LIKE CLIT OWE DIN YA 2616 01:52:06,757 --> 01:52:09,327 OR MIXED LIKE LOCALIZED OR 2617 01:52:09,327 --> 01:52:10,194 GENERALIZED VULVODYNIA IT MINUTE 2618 01:52:10,194 --> 01:52:13,598 MAY BE PROVOKED WITH INSERTIONAL 2619 01:52:13,598 --> 01:52:16,234 OR CONTACT PAIN AND SPONTANEOUS 2620 01:52:16,234 --> 01:52:19,070 OR MIXED WITH BOTH PROVOKED AND 2621 01:52:19,070 --> 01:52:22,540 SPONTANEOUS IT MIGHT ONLY AFFECT 2622 01:52:22,540 --> 01:52:29,680 THE VESTY BUELL WHICH IS KNOWN 2623 01:52:29,680 --> 01:52:34,852 VES TIBIA BÜLOW DIN YA WHICH WAS 2624 01:52:34,852 --> 01:52:36,387 PREVIOUSLY KNOWN AS VULVAR VES 2625 01:52:36,387 --> 01:52:38,489 TIBIA YOU LIGHTS SYNDROME. 2626 01:52:38,489 --> 01:52:40,491 THIS CAN OCCUR FROM THE VERY 2627 01:52:40,491 --> 01:52:42,393 FIRST TIME THE VULVAR WAS 2628 01:52:42,393 --> 01:52:43,828 CONTACTED OR SECONDARY AFTER A 2629 01:52:43,828 --> 01:52:46,364 PERIOD OF PAIN-FREE CONTACT. 2630 01:52:46,364 --> 01:52:49,000 AND IT CAN BE INTERMITTENT OR 2631 01:52:49,000 --> 01:52:50,835 CONSTANT, IMMEDIATE OR DELAYED. 2632 01:52:50,835 --> 01:52:55,706 NEXT SLIDE, PLEASE. AS HAS BEEN 2633 01:52:55,706 --> 01:52:58,476 MENTIONED THE LIFETIME ESTIMATES 2634 01:52:58,476 --> 01:53:01,545 OF -- IN TERMS OF PREVALENCE ARE 2635 01:53:01,545 --> 01:53:03,714 8-28% THE GENERAL POPULATION AND 2636 01:53:03,714 --> 01:53:10,288 THE MOST COMMON SUBTYPE IS 2637 01:53:10,288 --> 01:53:11,889 VESTIBULODYNIA WHERE THERE IS 2638 01:53:11,889 --> 01:53:16,294 PAIN ON THE CONTACT. DESPITE 2639 01:53:16,294 --> 01:53:19,497 THIS HIGH PREVALENCE ONLY 60% 2640 01:53:19,497 --> 01:53:26,804 LOOK FOR TREATMENT AND ONLY 50% 2641 01:53:26,804 --> 01:53:28,673 HAVE A DIAGNOSIS. AND IT IS 2642 01:53:28,673 --> 01:53:32,944 AFFECTING A HIGHER RATE OF 2643 01:53:32,944 --> 01:53:35,846 HISPANIC WOMEN. SO LIVING WITH 2644 01:53:35,846 --> 01:53:39,684 VULVODYNIA LIMITS ACTIVITIES OF 2645 01:53:39,684 --> 01:53:41,652 DAILY LIVING AS HAS ALSO BEEN 2646 01:53:41,652 --> 01:53:43,487 SPOKEN OF. HOW ABOUT SITTING 2647 01:53:43,487 --> 01:53:45,756 FOR EXTENDED PERIODS? THAT'S 2648 01:53:45,756 --> 01:53:47,959 AMAZING. THAT REALLY IMPACTS 2649 01:53:47,959 --> 01:53:50,361 DAILY LIFE. ENGAGING IN THINGS 2650 01:53:50,361 --> 01:53:52,330 LIKE PHYSICAL EXERCISE, SEXUAL 2651 01:53:52,330 --> 01:53:53,597 INTERCOURSE, SOME WOMEN RESIGN 2652 01:53:53,597 --> 01:53:54,732 FROM THEIR ABILITY TO WORK THEIR 2653 01:53:54,732 --> 01:53:56,567 JOBS BECAUSE THEY CANNOT SIT AND 2654 01:53:56,567 --> 01:53:59,270 THEY CANNOT GO THROUGH A DAY AT 2655 01:53:59,270 --> 01:54:00,004 WORK WITHOUT SO MUCH PAIN AND 2656 01:54:00,004 --> 01:54:02,506 THEY APPLY FOR DISABILITY. AND 2657 01:54:02,506 --> 01:54:04,141 THAT IS VERY DIFFICULT FILLING 2658 01:54:04,141 --> 01:54:05,142 OUT THOSE APPLICATIONS FOR 2659 01:54:05,142 --> 01:54:07,979 DISABILITY AND MANY TIMES ARE 2660 01:54:07,979 --> 01:54:09,347 DENIED THAT DISABILITY. SEVERAL 2661 01:54:09,347 --> 01:54:11,916 STUDIES THAT SUMMARIZE THE 2662 01:54:11,916 --> 01:54:14,418 NEGATIVE BIO PSYCHOSOCIAL 2663 01:54:14,418 --> 01:54:17,421 EFFECTS OF VULVODYNIA. NEXT 2664 01:54:17,421 --> 01:54:22,026 SLIDE, PLEASE. THE NATIONAL VIL 2665 01:54:22,026 --> 01:54:23,361 VULVODYNIA ASSOCIATION SHOWS 2666 01:54:23,361 --> 01:54:27,164 ONLINE TUTORIALS THAT INCLUDE 2667 01:54:27,164 --> 01:54:29,433 ESSENTIAL INFORMATION SO 2668 01:54:29,433 --> 01:54:31,502 PATIENTS CAN GIVE ADVICE ON 2669 01:54:31,502 --> 01:54:33,037 SEXUAL AND RELATIONSHIP ISSUES 2670 01:54:33,037 --> 01:54:34,105 AND MAXIMIZE HEALTH CARE VISITS 2671 01:54:34,105 --> 01:54:35,406 TO HAVE A LIST OF QUESTIONS 2672 01:54:35,406 --> 01:54:38,476 READY FOR THEIR PROVIDERS. THE 2673 01:54:38,476 --> 01:54:40,478 NATIONAL VULVODYNIA ASSOCIATION 2674 01:54:40,478 --> 01:54:43,047 HAS PUBLISHED FOUR ONLINE 2675 01:54:43,047 --> 01:54:44,648 EDUCATIONAL BOOKLETS. WE 2676 01:54:44,648 --> 01:54:45,516 MAINTAIN SEVERAL REFERRAL LISTS 2677 01:54:45,516 --> 01:54:49,120 ORGANIZED BY STATE AND COUNTRY. 2678 01:54:49,120 --> 01:54:49,887 HELPING THAT PATIENTS FIND 2679 01:54:49,887 --> 01:54:51,322 HEALTH CARE PROVIDERS WITH 2680 01:54:51,322 --> 01:54:52,790 EXPERTISE IN THE DIAGNOSIS AND 2681 01:54:52,790 --> 01:54:56,260 TREATMENT OF VULVAR PAIN AND WE 2682 01:54:56,260 --> 01:54:57,561 OFFER SUPPORT TO CONTACT AND 2683 01:54:57,561 --> 01:55:01,866 ANSWER PATIENTS' QUESTIONS 2684 01:55:01,866 --> 01:55:02,867 PROVIDING LOCAL RESOURCES AND 2685 01:55:02,867 --> 01:55:04,301 EMOTIONAL SUPPORT TO PATIENTS AS 2686 01:55:04,301 --> 01:55:07,204 WELL. NEXT SLIDE, PLEASE. WE 2687 01:55:07,204 --> 01:55:08,606 ALSO OFFER DIAGNOSTIC AND 2688 01:55:08,606 --> 01:55:10,775 TREATMENT ONLINE TUTORIAL 2689 01:55:10,775 --> 01:55:14,678 QUARTERLY RESEARCH ABSTRACTS ON 2690 01:55:14,678 --> 01:55:17,281 CHRONIC VULVAR PAIN THAT ALSO 2691 01:55:17,281 --> 01:55:21,285 INCLUDES ABSTRACTS ON PIE DENIAL 2692 01:55:21,285 --> 01:55:25,322 NEURALGIA AND PERSISTENT GENITAL 2693 01:55:25,322 --> 01:55:30,294 AROUSE SAL DISORDER. AND WE HA 2694 01:55:30,294 --> 01:55:31,929 RESEARCH GRANTS UP TO 100,000 2695 01:55:31,929 --> 01:55:35,699 DOLLARS. NEXT SLIDE, PLEASE. 2696 01:55:35,699 --> 01:55:38,035 TO DATE THE NVA RESEARCH GRANTS 2697 01:55:38,035 --> 01:55:40,004 THAT HAVE BEEN AWARDED SINCE 2698 01:55:40,004 --> 01:55:43,908 2004 HAVE TOTALLED ALMOST 2 2699 01:55:43,908 --> 01:55:45,609 MILLION DOLLARS IN PILOT 2700 01:55:45,609 --> 01:55:47,211 RESEARCH GRANTS THAT RANGE FROM 2701 01:55:47,211 --> 01:55:50,314 40,000 DOLLARS TO 75,000 DOLLARS 2702 01:55:50,314 --> 01:55:52,416 AT A TIME. WE HAVE GIVEN 2703 01:55:52,416 --> 01:55:55,052 RESEARCH TO PILOT DATA AND LARGE 2704 01:55:55,052 --> 01:55:57,788 GRANTS AS WELL. FROM THE NIH 2705 01:55:57,788 --> 01:55:59,890 AND CANADIAN INSTITUTE OF HEALTH 2706 01:55:59,890 --> 01:56:02,460 SOME GRANT RECIPIENTS INCLUDE 2707 01:56:02,460 --> 01:56:05,129 VERY, VERY IMPORTANT RESEARCHERS 2708 01:56:05,129 --> 01:56:08,766 LIKE MELISSA FARMER THAT USES 2709 01:56:08,766 --> 01:56:11,435 THE MOUSE MODEL OF VES TIBIA 2710 01:56:11,435 --> 01:56:14,071 BÜLOW DIN YA, AND MEGAN FALL 2711 01:56:14,071 --> 01:56:18,142 SETA THAT WE HEARD FROM IN TERMS 2712 01:56:18,142 --> 01:56:24,815 OF LOOKING AT THE FIE BBROBLAST 2713 01:56:24,815 --> 01:56:27,818 AND ALSO LOOKING FROM VALERIE 2714 01:56:27,818 --> 01:56:32,823 WHO LOOKS AT THE NEUROPHYSIO 2715 01:56:32,823 --> 01:56:34,391 LOGICAL AND PSYCHOLOGICAL 2716 01:56:34,391 --> 01:56:35,493 CORRELATES OF VULVODYNIA AND 2717 01:56:35,493 --> 01:56:38,095 LINDA WHO IS LOOKING AT THE LOW 2718 01:56:38,095 --> 01:56:39,563 LEVEL LASER THERAPY FOR PAIN. 2719 01:56:39,563 --> 01:56:43,234 NEXT SLIDE, PLEASE. WE ALSO 2720 01:56:43,234 --> 01:56:45,136 OFFER THE MARY NOVEMBER CAREER 2721 01:56:45,136 --> 01:56:48,239 DEVELOPMENT AWARD TO ENCOURAGE 2722 01:56:48,239 --> 01:56:50,107 JUNIOR FACULTY TO PURSUE A 2723 01:56:50,107 --> 01:56:52,443 CAREER IN VULVODYNIA RESEARCH. 2724 01:56:52,443 --> 01:56:55,479 AND WE GIVE IT TO SIX OF 2725 01:56:55,479 --> 01:56:57,381 FOURTEEN RECIPIENTS HAVE MADE 2726 01:56:57,381 --> 01:57:03,721 SIGNIFICANT CONTRIBUTIONS IN 2727 01:57:03,721 --> 01:57:05,122 VIL AND THERE ARE 11 PAIN 2728 01:57:05,122 --> 01:57:07,525 CLINICS THAT ARE STILL OPERATING 2729 01:57:07,525 --> 01:57:09,760 THAT THE NVA STARTED, GAVE THEM 2730 01:57:09,760 --> 01:57:11,695 THE SEED MONEY TO HELP OPERATE 2731 01:57:11,695 --> 01:57:15,166 IN AND THEY'RE SO OPEN. 2732 01:57:15,166 --> 01:57:18,335 INCLUDING ONE IN LUMBAR LYNN 2733 01:57:18,335 --> 01:57:18,836 POLAND. 2734 01:57:18,836 --> 01:57:20,971 NEXT SLIDE, PLEASE. 2735 01:57:20,971 --> 01:57:21,772 THE NEWSLETTERS ARE REALLY 2736 01:57:21,772 --> 01:57:22,806 SOMETHING THAT ARE JUST 2737 01:57:22,806 --> 01:57:25,543 WONDERFUL THE NEWSLETTERS 2738 01:57:25,543 --> 01:57:27,211 PUBLISHED RESEARCH ABSTRACTS 2739 01:57:27,211 --> 01:57:30,915 THAT ARE BOTH HELPFUL FOR 2740 01:57:30,915 --> 01:57:31,749 CLINICIANS AND PEOPLE WHO ARE 2741 01:57:31,749 --> 01:57:33,117 SUFFERING WITH VULVODYNIA ALIKE 2742 01:57:33,117 --> 01:57:35,186 THEY ALSO OFFER ADVICE FOR 2743 01:57:35,186 --> 01:57:38,055 SEXUAL INTIMACY AND INSPIRING 2744 01:57:38,055 --> 01:57:39,623 PERSONAL STORIES FOR WOMEN WITH 2745 01:57:39,623 --> 01:57:40,691 VULVODYNIA. PATIENTS SAY I'VE 2746 01:57:40,691 --> 01:57:42,426 JUST LEARNED SO MUCH FROM THE 2747 01:57:42,426 --> 01:57:43,260 NEWSLETTER AND MY DOCTOR 2748 01:57:43,260 --> 01:57:44,962 ACTUALLY READS THEM ALL THE TIME 2749 01:57:44,962 --> 01:57:47,531 WHICH IS TRUE. AND PATIENTS 2750 01:57:47,531 --> 01:57:48,966 ALSO SAY WHEN THEY ARE IN SO 2751 01:57:48,966 --> 01:57:50,367 MUCH EMOTIONAL PAIN AND 2752 01:57:50,367 --> 01:57:52,870 DEPRESSION THE ARTICLES IN THE 2753 01:57:52,870 --> 01:57:56,106 NEWSLETTER LIFT THEM UP. NEXT 2754 01:57:56,106 --> 01:57:58,475 SLIDE, PLEASE. THE NATIONAL 2755 01:57:58,475 --> 01:58:00,110 VULVODYNIA REGISTRY TOOK PLACE 2756 01:58:00,110 --> 01:58:03,314 BETWEEN 2009 AND 204 AND 2757 01:58:03,314 --> 01:58:05,216 ACTUALLY IDENTIFIED THE MEDIAN 2758 01:58:05,216 --> 01:58:07,351 PATIENT AGE OF VULVODYNIA IS 29. 2759 01:58:07,351 --> 01:58:10,487 THAT'S REALLY QUITE YOUNG. 90% 2760 01:58:10,487 --> 01:58:13,624 OF THE PATIENTS WERE DIAGNOSED 2761 01:58:13,624 --> 01:58:16,627 WITH VES TIBIA BUY LOW DIN YA IN 2762 01:58:16,627 --> 01:58:21,599 THE REGISTRY AND 90% WERE 2763 01:58:21,599 --> 01:58:23,067 DIAGNOSED WITH PELVIC FLOOR 2764 01:58:23,067 --> 01:58:25,069 DYSFUNCTION. AND MOST COMMON 2765 01:58:25,069 --> 01:58:27,571 TREATMENTS WERE CREAM, THERAPY, 2766 01:58:27,571 --> 01:58:29,707 AND THEN TRY CYCLIC 2767 01:58:29,707 --> 01:58:31,408 ANTIDEPRESSANTS OR 2768 01:58:31,408 --> 01:58:33,210 ANTICONVULSANTS LIKE GABAPENTIN 2769 01:58:33,210 --> 01:58:34,545 WERE THE THIRD MOST COMMON 2770 01:58:34,545 --> 01:58:35,946 TREATMENT. AFTER SIX MONTHS 2771 01:58:35,946 --> 01:58:37,781 THERE WAS REDUCED PAIN AND 2772 01:58:37,781 --> 01:58:39,750 PSYCHOLOGICAL DISTRESS WHICH IS 2773 01:58:39,750 --> 01:58:41,085 GREAT NEWS, HOWEVER, THEY 2774 01:58:41,085 --> 01:58:42,720 REPORTED NO IMPROVEMENT IN 2775 01:58:42,720 --> 01:58:44,321 SEXUAL FUNCTIONING WHICH IS 2776 01:58:44,321 --> 01:58:47,591 DISTURBING NEWS. NEXT SLIDE, 2777 01:58:47,591 --> 01:58:49,627 PLEASE. SINCE MEDICAL SCHOOLS 2778 01:58:49,627 --> 01:58:51,695 AND RESIDENCY PROGRAMS DID NOT 2779 01:58:51,695 --> 01:58:52,496 INCLUDE INFORMATION ON 2780 01:58:52,496 --> 01:58:54,365 VULVODYNIA IN THEIR PROGRAMS AT 2781 01:58:54,365 --> 01:58:56,166 THE TIME OF THE EARLY DAYS OF 2782 01:58:56,166 --> 01:58:59,370 THE NVA, THE NV A DECIDED TO 2783 01:58:59,370 --> 01:59:02,039 DEVELOP AN ONLINE SELF GUIDE 2784 01:59:02,039 --> 01:59:05,743 TUTORIAL WITH PRE AND POSTTESTS. 2785 01:59:05,743 --> 01:59:08,946 THAT WAS THE INFORMATION WAS 2786 01:59:08,946 --> 01:59:12,549 GIVEN VOLUNTARILY BY MANY 2787 01:59:12,549 --> 01:59:12,816 EXPERTS. 2788 01:59:12,816 --> 01:59:14,218 AND ALL THE VULVODYNIA SUPPORT 2789 01:59:14,218 --> 01:59:17,254 IS GIVEN BY EXPERTS, IT'S ALL 2790 01:59:17,254 --> 01:59:19,189 VOLUNTARY, NON PAID WITHIN SIX 2791 01:59:19,189 --> 01:59:23,594 MONTHS OF THE LAUNCH OF THE NVA 2792 01:59:23,594 --> 01:59:25,496 TUTORIAL, THERE -- IT BECAME THE 2793 01:59:25,496 --> 01:59:27,798 THIRD MOST POPULAR TUTORIAL ON 2794 01:59:27,798 --> 01:59:29,767 MEDSCAPE AND TO DATE 50,000 2795 01:59:29,767 --> 01:59:32,503 HEALTH CARE PROVIDERS HAVE 2796 01:59:32,503 --> 01:59:34,004 AVAILED THEMSELVES OF THE 2797 01:59:34,004 --> 01:59:37,875 TUTORIAL WITH 22,000 OF THEM 2798 01:59:37,875 --> 01:59:39,743 SUCCESSFULLY COMPLETING THE 2799 01:59:39,743 --> 01:59:41,812 POSTTEST. NEXT SLIDE. NVA 2800 01:59:41,812 --> 01:59:45,916 SUPPORT DIRECTOR OVERSEES DOZENS 2801 01:59:45,916 --> 01:59:48,652 OF SUPPORT LEADERS AND MONITORS 2802 01:59:48,652 --> 01:59:51,989 OUR INSTAGRAM PAGES FOR 2803 01:59:51,989 --> 01:59:54,124 SELF-HELP STRATEGIES AND 2804 01:59:54,124 --> 01:59:55,125 REPUBLISHES EXCERPTS FROM 2805 01:59:55,125 --> 01:59:57,194 PREVIOUS NEWSLETTERS AND GIVES 2806 01:59:57,194 --> 01:59:58,395 RESOURCES AND THE PATIENTS SAY 2807 01:59:58,395 --> 02:00:00,964 THAT REALLY THE NVA WAS AROUND 2808 02:00:00,964 --> 02:00:02,199 AND GAVE THEM AN OPPORTUNITY AS 2809 02:00:02,199 --> 02:00:04,001 PART OF A LARGER STRONGER 2810 02:00:04,001 --> 02:00:06,136 COMMUNITY. IT LIFTS THEM UP AND 2811 02:00:06,136 --> 02:00:07,871 GIVES THEM HOPE WHEN THEY'RE 2812 02:00:07,871 --> 02:00:09,840 LOSING HOPE AND HELPS THEM TO 2813 02:00:09,840 --> 02:00:11,675 GET THE CARE THEY NEED WHEN THEY 2814 02:00:11,675 --> 02:00:13,444 FEEL LIKE THEY DON'T HAVE 2815 02:00:13,444 --> 02:00:15,412 HOPEFULLY LONGER. THE NVA WAS 2816 02:00:15,412 --> 02:00:17,848 THERE AT THE VERY BEGINNING AND 2817 02:00:17,848 --> 02:00:20,851 WE THANK ORGANIZATIONS LIKE 2818 02:00:20,851 --> 02:00:24,254 TIGHT TIPPED FOR TAKING THE 2819 02:00:24,254 --> 02:00:27,324 BATON AND CARRYING IT ON. WE 2820 02:00:27,324 --> 02:00:29,927 EMPLOY THE NIH TO HELP US WITH 2821 02:00:29,927 --> 02:00:31,495 FUNDING AND HELP US GIVE MORE 2822 02:00:31,495 --> 02:00:34,164 FUNDING TO RESEARCHERS THAT YOU 2823 02:00:34,164 --> 02:00:36,900 WILL HEAR FROM OR HAVE HEARD 2824 02:00:36,900 --> 02:00:40,904 FROM TODAY BECAUSE WE NEED MORE 2825 02:00:40,904 --> 02:00:42,339 RESEARCH OF THIS TERRIBLE 2826 02:00:42,339 --> 02:00:44,508 CONDITION. YES, WE ALSO HELP TO 2827 02:00:44,508 --> 02:00:48,812 SUPPORT THE RESEARCH SUMMIT FROM 2828 02:00:48,812 --> 02:00:51,115 WHEN YOU HEARD THE WONDERFUL 2829 02:00:51,115 --> 02:00:53,350 IDEAS FROM DR. GOLDSTEIN IN THE 2830 02:00:53,350 --> 02:00:58,088 FALL OF 2024. THERE'LL 2831 02:00:58,088 --> 02:00:59,890 HOPEFULLY BE SOME SPONSORSHIP 2832 02:00:59,890 --> 02:01:02,760 FOR THEIR WORK. THANK YOU VERY 2833 02:01:02,760 --> 02:01:08,565 MUCH FOR YOUR TIME. 2834 02:01:08,565 --> 02:01:10,834 >> THANK YOU SO MUCH FOR THAT. 2835 02:01:10,834 --> 02:01:13,237 DEFINITELY WORTH THE WAIT. I AM 2836 02:01:13,237 --> 02:01:15,072 SURE OUR AUDIENCE IS VERY GLAD 2837 02:01:15,072 --> 02:01:17,141 TO HEAR THOSE RESOURCES. I AM 2838 02:01:17,141 --> 02:01:18,776 CERTAIN WE CAN PUT A LINK IN THE 2839 02:01:18,776 --> 02:01:22,913 Q&A AS WELL TO THE NVA, THANK 2840 02:01:22,913 --> 02:01:24,948 YOU SO MUCH DR. KELLOGG SPADT 2841 02:01:24,948 --> 02:01:26,817 FOR BEING HERE. WITH THAT 2842 02:01:26,817 --> 02:01:27,885 SESSION ONE IS COMPLETE AND I 2843 02:01:27,885 --> 02:01:32,356 WILL TURN IT OVER TO DR. HELENA 2844 02:01:32,356 --> 02:01:37,127 TO MODERATE THE NEXT SESSION. 2845 02:01:37,127 --> 02:01:38,562 >> THANK YOU SO MUCH. LET'S 2846 02:01:38,562 --> 02:01:42,466 START SESSION TWO. THE FIRST 2847 02:01:42,466 --> 02:01:52,409 SPEAKER IS MR. ZACHARY LYON THE 2848 02:01:52,409 --> 02:01:58,148 CEO AND PRESIDENT OF H 3 PELVIC 2849 02:01:58,148 --> 02:01:59,249 THERAPY SYSTEM THAT INCLUDES 2850 02:01:59,249 --> 02:02:02,853 YEARS OF PRODUCT DESIGN AND 2851 02:02:02,853 --> 02:02:05,656 ENGINEERING EXPERIENCE IN 2852 02:02:05,656 --> 02:02:06,723 AUTOMOTIVE AND INDUSTRIAL AND 2853 02:02:06,723 --> 02:02:10,427 MEDICAL DEVICE PRODUCT AND 2854 02:02:10,427 --> 02:02:18,001 ENGINEERING. MR. LYON IS 2855 02:02:18,001 --> 02:02:20,370 COLLABORATING WITH ANOTHER 2856 02:02:20,370 --> 02:02:23,507 DOCTOR FOR ADVANCED CONTROL AND 2857 02:02:23,507 --> 02:02:25,509 MONITORING OF THE TISSUE 2858 02:02:25,509 --> 02:02:28,045 TEMPERATURE. MR. LYON IS VERY 2859 02:02:28,045 --> 02:02:30,280 EXCITED TO BE PRESENTING 2860 02:02:30,280 --> 02:02:32,082 INNOVATIVE, SAFE AND HIGHLY 2861 02:02:32,082 --> 02:02:34,785 EFFECTIVE METHODS OF 2862 02:02:34,785 --> 02:02:35,285 NONPHARMACOLOGICAL PAIN 2863 02:02:35,285 --> 02:02:36,220 MANAGEMENT. MR. LYON, THE FLOOR 2864 02:02:36,220 --> 02:02:39,056 IS YOURS. 2865 02:02:39,056 --> 02:02:41,225 >> THANK YOU HELENA, CAN 2866 02:02:41,225 --> 02:02:43,160 EVERYONE HEAR ME OKAY? 2867 02:02:43,160 --> 02:02:43,927 >> YES. 2868 02:02:43,927 --> 02:02:49,199 >> YES, I AM CEO/FOUNDER OF H 3 2869 02:02:49,199 --> 02:02:50,601 PELVIC THERAPY SYSTEMS. WE ARE 2870 02:02:50,601 --> 02:02:54,771 TRYING TO HELP FOLKS WITH DEEPLY 2871 02:02:54,771 --> 02:02:57,174 AGGRAVATING PELVIC PAIN 2872 02:02:57,174 --> 02:02:59,409 CONDITIONS. USING PHYSICS. THE 2873 02:02:59,409 --> 02:03:04,915 THERAPY THAT WE COIN TNT. WE 2874 02:03:04,915 --> 02:03:09,052 KNOW THAT, WHOOPS, HANG ON A 2875 02:03:09,052 --> 02:03:14,157 SEC. IS IT TRANSFERRING? HANG 2876 02:03:14,157 --> 02:03:17,361 ON. LET'S SEE. IT IS NOT 2877 02:03:17,361 --> 02:03:19,863 MOVIN 2878 02:03:19,863 --> 02:03:20,364 MOVING. 2879 02:03:20,364 --> 02:03:21,565 >> YOU HAVE TO CLICK ON THE 2880 02:03:21,565 --> 02:03:22,733 ACTUAL PRESENTATION TO ACTIVATE 2881 02:03:22,733 --> 02:03:23,700 THE SLIDE. 2882 02:03:23,700 --> 02:03:27,271 >> SORRY, GUYS. ANYWAY, WE ARE 2883 02:03:27,271 --> 02:03:30,674 IN A -- A VICIOUS CYCLE OF 2884 02:03:30,674 --> 02:03:33,510 PELVIC PAIN IS TORMENTS, IT'S 2885 02:03:33,510 --> 02:03:35,546 EXPENSIVE AND THE MEDICATIONS 2886 02:03:35,546 --> 02:03:41,451 ARINGING A DWRA -- ARE AGGRAVAT. 2887 02:03:41,451 --> 02:03:44,121 IT'S FRUSTRATING FOR PHYSICIANS. 2888 02:03:44,121 --> 02:03:44,988 PHYSICIANS ARE VERY CHALLENGED 2889 02:03:44,988 --> 02:03:47,758 TO TRY TO FIND OUT WHAT MIGHT BE 2890 02:03:47,758 --> 02:03:48,458 CAUSING THEIR PATIENT'S 2891 02:03:48,458 --> 02:03:50,027 CONDITIONS IN THE VERY LITTLE 2892 02:03:50,027 --> 02:03:52,396 TIME THAT THEY HAVE TO TREAT 2893 02:03:52,396 --> 02:03:52,796 THEM. 2894 02:03:52,796 --> 02:03:54,431 AND SOME OF THESE PATIENTS END 2895 02:03:54,431 --> 02:03:56,199 UP IN THE HOSPITAL, IN THE 2896 02:03:56,199 --> 02:03:58,235 EMERGENCY ROOM LOOKING FOR HELP 2897 02:03:58,235 --> 02:04:00,637 AND DON'T GET HELP AND THAT'S 2898 02:04:00,637 --> 02:04:01,738 MANY TIMES NOT RIGHT PLACE FOR 2899 02:04:01,738 --> 02:04:03,574 THESE TYPES OF CONDITIONS SO 2900 02:04:03,574 --> 02:04:05,142 IT'S A HUGE EXPENSE TO THE 2901 02:04:05,142 --> 02:04:09,479 HEALTH CARE SYSTEM. SO WE DID A 2902 02:04:09,479 --> 02:04:12,182 SURVEY TO ON AN OUR OWN TO 2903 02:04:12,182 --> 02:04:13,450 DISCOVER THESE LOCATIONS OF USER 2904 02:04:13,450 --> 02:04:15,352 GROUPS AND SHARING COMMUNITIES 2905 02:04:15,352 --> 02:04:18,121 OF HOW CONSTANT IS YOUR PAIN AND 2906 02:04:18,121 --> 02:04:21,491 OVER 85% OF 50 CORRESPONDENTS 2907 02:04:21,491 --> 02:04:26,563 SAID CONSTANT AND DAILY SO IT'S 2908 02:04:26,563 --> 02:04:29,600 EXTREMELY AGGRAVATING THE TOP 2909 02:04:29,600 --> 02:04:32,402 TWO QUESTIONS, IN YOUR SEARCH 2910 02:04:32,402 --> 02:04:34,104 FOR PAIN AND HEALING WHAT IS 2911 02:04:34,104 --> 02:04:35,606 YOUR BIGGEST CHALLENGE? THE 2912 02:04:35,606 --> 02:04:37,441 PAIN THAT WON'T GO AWAY AND LACK 2913 02:04:37,441 --> 02:04:39,209 OF DOCTOR UNDERSTANDING WHICH 2914 02:04:39,209 --> 02:04:41,044 WAS INTERESTING BUT NONETHELESS 2915 02:04:41,044 --> 02:04:43,714 WHEN YOU ASK HOW MUCH THEY SPENT 2916 02:04:43,714 --> 02:04:48,885 TRYING TO GET RESOLUTION 61% 2917 02:04:48,885 --> 02:04:51,688 SPENT A LOT OUT-OF-POCKET. 2918 02:04:51,688 --> 02:04:52,723 THESE CONDITIONS MIGHT UNDERLIE 2919 02:04:52,723 --> 02:04:56,226 THE PAIN INDUCING STATE ARE 2920 02:04:56,226 --> 02:04:57,227 EXTREMELY EXPENSIVE THE GREEN 2921 02:04:57,227 --> 02:04:58,462 LINE THAT YOU SEE HERE IS AN 2922 02:04:58,462 --> 02:05:01,231 AREA THAT WE'RE VERY INTERESTED 2923 02:05:01,231 --> 02:05:03,400 IN AND PART OF WHERE WE'RE GOING 2924 02:05:03,400 --> 02:05:07,237 WITH OUR GRANT. THE OTHER ONES 2925 02:05:07,237 --> 02:05:07,871 WITH QUESTION MARKS ARE AREAS 2926 02:05:07,871 --> 02:05:08,605 THAT WE THINK WE CAN TILL HAVE 2927 02:05:08,605 --> 02:05:11,775 SOME IMPROVEMENT AND YOU WILL 2928 02:05:11,775 --> 02:05:12,476 LEARN TO UNDERSTAND THAT AS WE 2929 02:05:12,476 --> 02:05:14,811 GO OY LONG. THE COST BURDEN IS 2930 02:05:14,811 --> 02:05:16,513 HUGE WHEREAS ONE IN FIVE WOMEN 2931 02:05:16,513 --> 02:05:17,848 AND ONE OUT OF TWELVE MEN AT 2932 02:05:17,848 --> 02:05:19,583 SOME POINT IN THEIR LIFETIME 2933 02:05:19,583 --> 02:05:22,052 WHEN THEY GET CHRONIC PELVIC 2934 02:05:22,052 --> 02:05:24,955 PAIN CONDITIONS IT BECOMES VERY 2935 02:05:24,955 --> 02:05:26,857 EXPENSIVE THE CHALLENGE IS 2936 02:05:26,857 --> 02:05:28,458 HOW -- WHEN YOU TAKE OVER 26 2937 02:05:28,458 --> 02:05:30,427 DAYS TO SEE YOUR DOCTOR, YOU'RE 2938 02:05:30,427 --> 02:05:32,729 SUFFERING IN PAIN FOR THAT 2939 02:05:32,729 --> 02:05:33,897 PERIOD OF TIME IF YOU DON'T HAVE 2940 02:05:33,897 --> 02:05:36,566 ANY WAY TO ABATE. HOW DO WE 2941 02:05:36,566 --> 02:05:38,168 TRANSFER THAT AND THE 2942 02:05:38,168 --> 02:05:39,436 FRUSTRATION THE PHYSICIAN HAS 2943 02:05:39,436 --> 02:05:42,639 DUE TO THE BRIEF PERIOD OF TIME 2944 02:05:42,639 --> 02:05:44,408 HE HAS TO SEE YOU AND THAT 2945 02:05:44,408 --> 02:05:47,210 THEY'LL BE DROPPING INTO 2946 02:05:47,210 --> 02:05:50,881 GRATITUDE AND TRANSFER THAT INTO 2947 02:05:50,881 --> 02:05:54,484 IMMEDIATE RELIEF NOT... ANYWAY. 2948 02:05:54,484 --> 02:05:56,086 THERMAL NEUROMODULATION THERAPY 2949 02:05:56,086 --> 02:05:58,021 IS THE TECHNIQUE TO MANAGE THESE 2950 02:05:58,021 --> 02:06:01,825 TYPES OF PAIN. WE ALL KNOW THAT 2951 02:06:01,825 --> 02:06:04,695 THERMAL THERAPY WORKS WELL WHERE 2952 02:06:04,695 --> 02:06:06,229 WE'RE ABLE TO HARNESS WARM TO 2953 02:06:06,229 --> 02:06:10,600 HOT, HOT TO COLD, AD NAUSEAM FOR 2954 02:06:10,600 --> 02:06:12,602 ANY PARTICULAR PROTOCOL THAT WE 2955 02:06:12,602 --> 02:06:14,571 MAY CONFIGURE IN THE FUTURE. 2956 02:06:14,571 --> 02:06:17,140 THIS IS IMPORTANT. BECAUSE FOR 2957 02:06:17,140 --> 02:06:20,110 THE COLD SIDE WE KNOW 2958 02:06:20,110 --> 02:06:22,879 INFLAMMATION DRIVES PAIN IF WE 2959 02:06:22,879 --> 02:06:26,316 ADDRESS THE ROOT CAUSE OF THIS 2960 02:06:26,316 --> 02:06:27,217 INFLAMMATION WE KNOW WE ARE 2961 02:06:27,217 --> 02:06:29,686 SHUNTING THE PAIN. IN THE CASE 2962 02:06:29,686 --> 02:06:33,190 OF THE TRPM8 CHANNELS WE ARE 2963 02:06:33,190 --> 02:06:35,892 AFFECTING THE VOLTAGE OF THE 2964 02:06:35,892 --> 02:06:40,197 NEURONS TO SHUNT THE RECEPTORS. 2965 02:06:40,197 --> 02:06:43,633 AND IT ALSO ELICITS INFLAMMATORY 2966 02:06:43,633 --> 02:06:44,968 FUNCTIONS WHICH IS EVEN MORE 2967 02:06:44,968 --> 02:06:46,970 BENEFICIAL TO THOSE THAT ARE 2968 02:06:46,970 --> 02:06:48,972 SUFFERING FROM INFLAMMATION-TYPE 2969 02:06:48,972 --> 02:06:51,308 CONDITIONS. WE ALSO ARE ABLE TO 2970 02:06:51,308 --> 02:06:55,112 CYCLE DUE TO THE CYCLICAL STATE 2971 02:06:55,112 --> 02:06:57,781 OF OUR THERMAL MODULATION 2972 02:06:57,781 --> 02:07:00,684 THERAPY UP, ABOVE AND BELOW CORE 2973 02:07:00,684 --> 02:07:02,252 BODY TEMPERATURE AND THIS IS A 2974 02:07:02,252 --> 02:07:04,821 KNOWN PHENOMENA OF ACCELERATING 2975 02:07:04,821 --> 02:07:07,023 HUMAN BODY HEALING FOR THOSE 2976 02:07:07,023 --> 02:07:09,359 SITUATIONS WHERE WE MAY HAVE 2977 02:07:09,359 --> 02:07:10,927 WOUNDS OR SORES THAT NEED TO 2978 02:07:10,927 --> 02:07:12,729 RAPIDLY HEAL THEY NEED TO HEAL 2979 02:07:12,729 --> 02:07:15,098 MUCH QUICKER THAN THEY CAN 2980 02:07:15,098 --> 02:07:16,433 WITHOUT THIS TYPE OF INFLUENCE 2981 02:07:16,433 --> 02:07:17,367 WE'RE ABLE TO HELP THOSE 2982 02:07:17,367 --> 02:07:18,568 CONDITIONS AS WELL. WHY DOES 2983 02:07:18,568 --> 02:07:20,237 THIS MATTER? THIS MATTERS 2984 02:07:20,237 --> 02:07:25,142 BECAUSE OUR DEVICES CAN CARRY 2985 02:07:25,142 --> 02:07:26,810 THAT SAME COOLING THERAPY. 2986 02:07:26,810 --> 02:07:28,011 WE'RE ABLE TO INTRODUCE THAT 2987 02:07:28,011 --> 02:07:31,515 INTO THE VAGINAL LUMEN FOR THOSE 2988 02:07:31,515 --> 02:07:35,786 THAT ACCEPT A TAMPON SIZE PROBE 2989 02:07:35,786 --> 02:07:37,788 TO GIVE COOLING ENERGY. THIS IS 2990 02:07:37,788 --> 02:07:41,658 A CONSOLE ANALYTICAL STUDY OF 2991 02:07:41,658 --> 02:07:43,927 PERFUSE TISSUES WITH OUR 2992 02:07:43,927 --> 02:07:46,963 SIMULATED DEVICE TRANSMITTING 2993 02:07:46,963 --> 02:07:48,498 THERMAL ENERGY INTO THE TISSUES 2994 02:07:48,498 --> 02:07:51,334 IN THE PELVIC REGION THE STUDY 2995 02:07:51,334 --> 02:07:53,270 THAT WE'RE DOING WITH DUKE 2996 02:07:53,270 --> 02:07:59,309 UNIVERSITY IS TO UTILIZE RAID I 2997 02:07:59,309 --> 02:08:01,545 DON'T MEAN TRY, HOW DEEP WE'RE 2998 02:08:01,545 --> 02:08:03,513 ABLE TO TRANSMIT THE ENERGY, 2999 02:08:03,513 --> 02:08:05,849 WHETHER COLD OR WARM INTO THESE 3000 02:08:05,849 --> 02:08:09,486 HIGH DENSE SENSITIZED REGIONS OF 3001 02:08:09,486 --> 02:08:10,020 THE HUMAN PELVIC CAVITY 3002 02:08:10,020 --> 02:08:12,255 ANATOMIES THE PRACTICAL 3003 02:08:12,255 --> 02:08:13,824 APPLICATIONS AS WE SAW BEFORE IS 3004 02:08:13,824 --> 02:08:18,361 A SIMPLE TAMM TAMM RESPONSE 3005 02:08:18,361 --> 02:08:19,329 SIZED DEVICE. 3006 02:08:19,329 --> 02:08:21,898 AS WE CAN SEE HERE IN THE 3007 02:08:21,898 --> 02:08:22,599 THERMAL IMAGE. 3008 02:08:22,599 --> 02:08:24,968 YOU CAN SEE HOW THIS COOLING 3009 02:08:24,968 --> 02:08:26,770 ENERGY DELIVERS DIRECTLY INTO 3010 02:08:26,770 --> 02:08:29,272 THE PARTICULAR SILVER PLATEDED 3011 02:08:29,272 --> 02:08:32,375 PROBE WITH NO ELECTRICITY, NO 3012 02:08:32,375 --> 02:08:34,044 FLUID WHATSOEVER. 3013 02:08:34,044 --> 02:08:35,045 SIMPLE ENERGY ALTHOUGH DELIVERED 3014 02:08:35,045 --> 02:08:37,614 VERY, VERY RAPIDLY. SO THE 3015 02:08:37,614 --> 02:08:40,450 RELEVANT ANIMAL MODEL WE MIGHT 3016 02:08:40,450 --> 02:08:44,487 STUDY THIS IN IS THE SWIPE DUE 3017 02:08:44,487 --> 02:08:47,357 TO THE RELATIVE SCALE OF THE 3018 02:08:47,357 --> 02:08:48,992 SUBJECTS. SO AS YOU CAN IMAGINE 3019 02:08:48,992 --> 02:08:51,328 THE HUMAN DEVICE AND THE SWINE 3020 02:08:51,328 --> 02:08:53,396 DEVICE IS QUITE DIFFERENT SO WE 3021 02:08:53,396 --> 02:08:59,035 HAVE TO ISOLATE THE AREA FROM, 3022 02:08:59,035 --> 02:09:01,004 I'M GOING TO RUN THIS THERMAL 3023 02:09:01,004 --> 02:09:02,606 ANALYSIS SO YOU CAN SEE HOW THE 3024 02:09:02,606 --> 02:09:04,708 PIG PROBE WORKS WE'RE SIMULATING 3025 02:09:04,708 --> 02:09:05,475 THE COOLING ENERGY AT THE BASE 3026 02:09:05,475 --> 02:09:07,444 OF THE PROBE AND HOW IT 3027 02:09:07,444 --> 02:09:08,745 TRANSFERS THAT TO THE FOCAL 3028 02:09:08,745 --> 02:09:10,480 POINT OF WHAT WOULD BE THE HUMAN 3029 02:09:10,480 --> 02:09:12,015 PROBE THAT YOU SAW IN THE 3030 02:09:12,015 --> 02:09:13,316 SMALLER UNIT AND WE HAD TO 3031 02:09:13,316 --> 02:09:14,584 DESIGN SUCH A THING AS THIS 3032 02:09:14,584 --> 02:09:16,853 BECAUSE IF YOU LOOK AT THE 3033 02:09:16,853 --> 02:09:17,787 ANATOMY OF THE SWINE YOU WILL 3034 02:09:17,787 --> 02:09:19,756 SEE THE BLADDER IS MUCH, MUCH 3035 02:09:19,756 --> 02:09:23,426 DEEPER IN THE WAY FROM THE HUMAN 3036 02:09:23,426 --> 02:09:28,932 IN RELATION OF THE HAVE A 3037 02:09:28,932 --> 02:09:33,303 VAGINA TO THE BLADDER. 3038 02:09:33,303 --> 02:09:35,906 THIS A CROSS SECTION SHOWING HOW 3039 02:09:35,906 --> 02:09:37,407 WE WILL PLACE THE SENSORS TO GET 3040 02:09:37,407 --> 02:09:39,643 THE DATA. IT'S KIND OF 3041 02:09:39,643 --> 02:09:42,045 COMPLICATED BUT WE WANT TO KNOW 3042 02:09:42,045 --> 02:09:44,714 HOW DEEP AND WHAT'S THE RADIAL 3043 02:09:44,714 --> 02:09:46,483 OUTPUT OF THIS THERMAL ENERGY 3044 02:09:46,483 --> 02:09:48,485 INTO THE DEEPLY INNERVATED OF 3045 02:09:48,485 --> 02:09:52,188 THE PELVIC CAVITY. SO, 3046 02:09:52,188 --> 02:09:54,758 COMMERCIALLY, THIS IS AN EXAMPLE 3047 02:09:54,758 --> 02:09:58,762 OF WHAT A SYMPTOM OF THIS MIGHT 3048 02:09:58,762 --> 02:10:00,530 LOOK LIKE. AND OUR 3049 02:10:00,530 --> 02:10:01,298 FORWARD-THINKING WOULD BE A 3050 02:10:01,298 --> 02:10:02,966 PERSONAL HOME DELIVERED DEVICE 3051 02:10:02,966 --> 02:10:06,870 THAT'S UTILIZED IN THE DIGNITY, 3052 02:10:06,870 --> 02:10:09,339 THE SANCTITY, THE PRIVACY OF 3053 02:10:09,339 --> 02:10:10,707 ONE'S HOME WHERE THEY'RE STAYING 3054 02:10:10,707 --> 02:10:15,645 OUT OF THE EMERGENCY ROOM. THE 3055 02:10:15,645 --> 02:10:17,747 PHYSICIAN CAN HAVE THIS 3056 02:10:17,747 --> 02:10:18,348 DELIVERED TO THE PATIENT AND 3057 02:10:18,348 --> 02:10:20,684 THEY CAN BE ON THEIR WAY TO AT 3058 02:10:20,684 --> 02:10:24,187 LEAST PAIN MANAGEMENT IF NOT 3059 02:10:24,187 --> 02:10:25,355 RECOVERY. THE PROBE IS OUR 3060 02:10:25,355 --> 02:10:27,157 CURRENT FOCUS IN THE RESEARCH 3061 02:10:27,157 --> 02:10:28,091 PROJECT FOR THOSE THAT CAN 3062 02:10:28,091 --> 02:10:30,126 ACCEPT SUCH A DEVICE AND REALIZE 3063 02:10:30,126 --> 02:10:37,901 THE COOLING OR THE WARP D -- 3064 02:10:37,901 --> 02:10:38,768 WARMING. 3065 02:10:38,768 --> 02:10:40,603 PELVIC INFLAMMATORY DISEASE, 3066 02:10:40,603 --> 02:10:42,072 THESE ARE AREAS OF STUDY THAT 3067 02:10:42,072 --> 02:10:44,274 WE'LL FOCUS ON IN THE FUTURE. 3068 02:10:44,274 --> 02:10:46,676 THIS IS JUST THE NEXT GENERATION 3069 02:10:46,676 --> 02:10:48,778 UNIT WHERE WE WOULD HAVE A 3070 02:10:48,778 --> 02:10:51,348 MUCH -- THIS WILL BE A MUCH 3071 02:10:51,348 --> 02:10:51,848 SMALLER UNIT BUT IT'S 3072 02:10:51,848 --> 02:10:53,583 SELF-CONTAINED AND DESIGNED FOR 3073 02:10:53,583 --> 02:10:55,185 LOWER RESOURCE SETTINGS. THIS 3074 02:10:55,185 --> 02:10:56,553 AN EXAMPLE OF OUR FORWARD 3075 02:10:56,553 --> 02:10:57,787 THINKING AND THIS IS HOW WE KNOW 3076 02:10:57,787 --> 02:10:59,923 WHAT WE KNOW WE BUILT MANY OF 3077 02:10:59,923 --> 02:11:01,391 THESE SYSTEMS. WE SHIPPED THEM 3078 02:11:01,391 --> 02:11:03,626 TO LOCAL PHYSICIANS WHO ASKED US 3079 02:11:03,626 --> 02:11:06,096 FOR THEM. FOLKS WHO FOUND US ON 3080 02:11:06,096 --> 02:11:08,431 USER GROUPS HAVE REACHED OUT TO 3081 02:11:08,431 --> 02:11:09,933 US. WE KNOW WHAT WE KNOW 3082 02:11:09,933 --> 02:11:11,601 BECAUSE THEY REACHED OUT AND 3083 02:11:11,601 --> 02:11:13,103 THERE'S BEEN INTERESTING 3084 02:11:13,103 --> 02:11:15,005 TESTIMONIALS AND I WANT TO PLAY 3085 02:11:15,005 --> 02:11:18,108 A QUICK SHORT 45 SECOND VIDEO 3086 02:11:18,108 --> 02:11:20,477 MONTAGE HERE IF THIS WILL COME 3087 02:11:20,477 --> 02:11:30,587 UP. . 3088 02:11:31,755 --> 02:11:33,323 >> IT SEEMS LIKE A LITTLE BIT OF 3089 02:11:33,323 --> 02:11:34,791 SOMETHING CHANGED WITH YOU 3090 02:11:34,791 --> 02:11:35,058 POSSIBLY. 3091 02:11:35,058 --> 02:11:38,161 >> YEAH. BECAUSE I DON'T NEED 3092 02:11:38,161 --> 02:11:40,230 THE MACHINE THAT MUCH ANYMORE. 3093 02:11:40,230 --> 02:11:43,733 YOU CAN'T HAVE IT BACK. 3094 02:11:43,733 --> 02:11:44,834 >> THERE MUST BE A BETTER WAY TO 3095 02:11:44,834 --> 02:11:47,871 DO THIS. IN THE PROCESS OF WHAT 3096 02:11:47,871 --> 02:11:50,540 WE SAW IN MY ISSUE, AFTER HAVING 3097 02:11:50,540 --> 02:11:53,376 KIND OF COME UP WITH THIS IDEA, 3098 02:11:53,376 --> 02:11:55,912 AND RESEARCHING NOT JUST MY 3099 02:11:55,912 --> 02:11:57,514 ISSUE, MY ISSUE'S MINOR COMPARED 3100 02:11:57,514 --> 02:11:59,382 TO -- ALL THE OTHERS THAT YOU 3101 02:11:59,382 --> 02:12:01,084 GUYS ARE REALLY AWARE OF AND I 3102 02:12:01,084 --> 02:12:04,220 BECAME AWARE OF HOW BIG THIS IS 3103 02:12:04,220 --> 02:12:07,590 AND HOW IT MIGHT REALLY IMPACT 3104 02:12:07,590 --> 02:12:09,492 THE WORLD OF PELVIC PAIN. 3105 02:12:09,492 --> 02:12:11,461 >> OKAY. THANK YOU, I JUST 3106 02:12:11,461 --> 02:12:12,962 WANTED TO SHARE THAT REAL QUICK 3107 02:12:12,962 --> 02:12:14,964 BECAUSE I THINK THAT'S A GOOD 3108 02:12:14,964 --> 02:12:17,434 EXAMPLE. WHERE WE ARE TODAY AS 3109 02:12:17,434 --> 02:12:20,403 FAR AS TRACTION IS CONCERNED WE 3110 02:12:20,403 --> 02:12:22,939 WERE FORMED IN 2020, IN 2022 WAS 3111 02:12:22,939 --> 02:12:25,141 THE YEAR OF DISCOVERY WE APPLIED 3112 02:12:25,141 --> 02:12:29,512 FOR MULTIPLE PATENTS. IN 2022 3113 02:12:29,512 --> 02:12:31,181 WHERE WE HAD TO PERSEVERE WE HAD 3114 02:12:31,181 --> 02:12:33,216 TWO REJECTIONS WITH THE NIH BUT 3115 02:12:33,216 --> 02:12:35,985 WE IN 2023 THEY HONORED US WITH 3116 02:12:35,985 --> 02:12:38,121 AN AWARD OF A PHASE ONE WE DID 3117 02:12:38,121 --> 02:12:45,095 APPLY FOR A THIRD PATENT IN 3118 02:12:45,095 --> 02:12:49,699 2022. IN YEAR TO YEAR WE ARE 3119 02:12:49,699 --> 02:12:54,737 MOVING FORWARD. WITHOUT THE 3120 02:12:54,737 --> 02:12:56,940 HEAL GRANT THIS WOULD NOT BE 3121 02:12:56,940 --> 02:12:57,607 POSSIBLE. WE HAVE 3122 02:12:57,607 --> 02:12:59,008 REPRESENTATION IN MARKETING, 3123 02:12:59,008 --> 02:13:00,944 TECHNOLOGY, FULL STACK 3124 02:13:00,944 --> 02:13:01,845 DEVELOPMENT, SALES, QUALITY 3125 02:13:01,845 --> 02:13:04,481 SYSTEMS, REGULATORY ADVISORIES 3126 02:13:04,481 --> 02:13:07,283 AS WELL AS SMALL BUSINESS 3127 02:13:07,283 --> 02:13:08,585 EXPERTISE. I'M HERE TODAY 3128 02:13:08,585 --> 02:13:09,919 BECAUSE WE HAVE A REALLY 3129 02:13:09,919 --> 02:13:11,421 INTERESTING SYSTEM THAT MAY HAVE 3130 02:13:11,421 --> 02:13:13,389 PREDICATES BUT IT MAY NOT HAVE 3131 02:13:13,389 --> 02:13:14,324 PREDICATES AND WE WOULD LIKE TO 3132 02:13:14,324 --> 02:13:16,426 CONNECT WITH THE FDA TO 3133 02:13:16,426 --> 02:13:17,861 UNDERSTAND HOW DO WE MOVE THIS 3134 02:13:17,861 --> 02:13:19,729 PRODUCT THAT SEEMS TO WORK 3135 02:13:19,729 --> 02:13:21,197 REALLY WELL INTO THE COMMERCIAL 3136 02:13:21,197 --> 02:13:23,633 SPACE AS RAPIDLY AS POSSIBLE? 3137 02:13:23,633 --> 02:13:25,168 IT IS A NONSIGNIFICANT RISK TYPE 3138 02:13:25,168 --> 02:13:28,404 DEVICE. WE CAN TELL AND I THINK 3139 02:13:28,404 --> 02:13:30,140 A TREMENDOUS NUMBER OF PEOPLE 3140 02:13:30,140 --> 02:13:31,608 COULD BENEFIT FROM IT. ON THAT 3141 02:13:31,608 --> 02:13:33,309 PAGE THAT HAS TO DO WITH CODES 3142 02:13:33,309 --> 02:13:35,011 AND I WON'T GET INTO THAT TODAY. 3143 02:13:35,011 --> 02:13:36,613 WE ARE LOOKING TO CREATE A NEW 3144 02:13:36,613 --> 02:13:40,583 STANDARD OF CARE OF HOW WE TREAT 3145 02:13:40,583 --> 02:13:43,953 PELVIC PAIN CONDITIONS. SAVING 3146 02:13:43,953 --> 02:13:45,688 HEALTH CARE COSTS, KEEPING 3147 02:13:45,688 --> 02:13:47,323 PEOPLE OUT OF THE EMERGENCY 3148 02:13:47,323 --> 02:13:49,425 ROOM, LET THEM TREAT AT HOME, 3149 02:13:49,425 --> 02:13:51,628 WITH TIME RESOLVING SOLUTIONS 3150 02:13:51,628 --> 02:13:53,263 THEY DIDN'T GET INTO THESE 3151 02:13:53,263 --> 02:13:54,531 PELVIC PAIN CONDITIONS OVERNIGHT 3152 02:13:54,531 --> 02:13:55,732 AND THEY WILL PROBABLY NOT GET 3153 02:13:55,732 --> 02:13:58,134 OUT OF THEM OVERNIGHT EITHER BUT 3154 02:13:58,134 --> 02:13:59,536 GIVING THEM A TOOL THAT HELPS 3155 02:13:59,536 --> 02:14:01,404 THEM TO MANAGE THEIR OWN PELVIC 3156 02:14:01,404 --> 02:14:03,840 PAIN TO POTENTIALLY BE RESOLVED 3157 02:14:03,840 --> 02:14:05,175 OVER TIME IT WOULD BE A 3158 02:14:05,175 --> 02:14:06,776 WONDERFUL, WONDERFUL THING AND 3159 02:14:06,776 --> 02:14:08,945 THAT'S OUR ULTIMATE GOAL HELPING 3160 02:14:08,945 --> 02:14:10,513 PATIENTS IMPROVE THE HEALTH CARE 3161 02:14:10,513 --> 02:14:13,283 SYSTEM AND I THANK YOU FOR 3162 02:14:13,283 --> 02:14:16,953 EVERYONE'S TIME. 3163 02:14:16,953 --> 02:14:22,559 >> THANK YOU SO MUCH MR. LYON. 3164 02:14:22,559 --> 02:14:24,494 I SEE THAT. WE HAVE ONE 3165 02:14:24,494 --> 02:14:27,096 QUESTION. FROM THE AUDIENCE. 3166 02:14:27,096 --> 02:14:32,969 WHAT IS DEVICE MADE OF? 3167 02:14:32,969 --> 02:14:35,205 >> WHICH DEVICE ARE WE TALKING 3168 02:14:35,205 --> 02:14:37,373 ABOUT? THE PROBE ITSELF OR THE 3169 02:14:37,373 --> 02:14:38,942 SEAT? 3170 02:14:38,942 --> 02:14:42,011 >> CAN YOU SEE THE Q&A BOX? 3171 02:14:42,011 --> 02:14:47,350 >> LET'S SEE. Q&A. WHAT IS THE 3172 02:14:47,350 --> 02:14:49,752 DEVICE MADE OF? THE ACTUAL SEAT 3173 02:14:49,752 --> 02:14:52,922 WOULD BE BIOCOMPATIBLE. IT IT 3174 02:14:52,922 --> 02:14:54,691 WOULD BE OF A FOAM MATERIAL 3175 02:14:54,691 --> 02:14:56,559 THAT'S ALREADY KNOWN TO BE 3176 02:14:56,559 --> 02:15:00,230 MEDICALLY BIOCOMPATIBLE, THE 3177 02:15:00,230 --> 02:15:01,998 MEMBRANE -- THE LATEX MEMBRANE 3178 02:15:01,998 --> 02:15:04,133 BUT FOR THOSE WITH A LATEX 3179 02:15:04,133 --> 02:15:08,104 ALLERGY WE HAVE REPLACED IT WITH 3180 02:15:08,104 --> 02:15:09,939 NEOPREEN OR VINYL TYPE MEMBRANES 3181 02:15:09,939 --> 02:15:11,407 THE ACTUAL PROBE ITSELF IS A 3182 02:15:11,407 --> 02:15:14,510 SILVER PLAITED BIOCOMPATIBLE 3183 02:15:14,510 --> 02:15:15,178 MATERIAL AND IT'S VERY SAFE FOR 3184 02:15:15,178 --> 02:15:22,585 THE MOST PART. ANY OTHER 3185 02:15:22,585 --> 02:15:22,986 QUESTIONS? 3186 02:15:22,986 --> 02:15:28,725 >> THANK YOU. I HAVE ONE 3187 02:15:28,725 --> 02:15:31,127 QUESTION, MR. LYON. BUT IT'S 3188 02:15:31,127 --> 02:15:35,865 ALREADY IF:40IT'SALREADY AALREA0 3189 02:15:35,865 --> 02:15:38,501 IF:40ALREADY ITALREADY I'ALSALR 3190 02:15:38,501 --> 02:15:41,271 ALREADY IF:40 -- 3:40 I CAN ASK 3191 02:15:41,271 --> 02:15:43,339 A QUESTION LATER. IF WE SEE 3192 02:15:43,339 --> 02:15:44,774 MORE QUESTIONS CAN YOU ADDRESS 3193 02:15:44,774 --> 02:15:46,676 THEM IN THE Q&A BOX? 3194 02:15:46,676 --> 02:15:48,344 >> I WILL DO THAT. 3195 02:15:48,344 --> 02:15:49,512 >> THANK YOU SO MUCH. 3196 02:15:49,512 --> 02:15:56,219 >> SO OUR NEXT SPEAKER, IS 3197 02:15:56,219 --> 02:16:02,325 DR. JOSÉ CAN YOU SHARE YOUR 3198 02:16:02,325 --> 02:16:04,327 SLIDES WHILE I'M INTRODUCING 3199 02:16:04,327 --> 02:16:08,965 YOU? SO THE DOCTOR IS A FOUNDER 3200 02:16:08,965 --> 02:16:11,968 OF A PELVIC FLOOR FIRM 3201 02:16:11,968 --> 02:16:15,138 SPECIALIZING IN WIRELESS MEDICAL 3202 02:16:15,138 --> 02:16:18,608 DEVICES. AT BOLD TYPE JOSÉ 3203 02:16:18,608 --> 02:16:21,177 LEADS A TEAM OF DESIGNERS WITH 3204 02:16:21,177 --> 02:16:23,680 EXPERTISE IN THE INDUSTRY OF 3205 02:16:23,680 --> 02:16:24,947 DESIGN, MECHANICAL ENGINEERING, 3206 02:16:24,947 --> 02:16:27,317 MOBILE APPS, CLOUD 3207 02:16:27,317 --> 02:16:27,950 INFRASTRUCTURE, CYBER SECURITY 3208 02:16:27,950 --> 02:16:32,155 AND DATA ANALYTICS. DR. B., THE 3209 02:16:32,155 --> 02:16:34,824 FLOOR IS YOURS. 3210 02:16:34,824 --> 02:16:36,025 >> THANK YOU AND CAN EVERYBODY 3211 02:16:36,025 --> 02:16:36,426 HEAR ME? 3212 02:16:36,426 --> 02:16:37,360 >> YES. 3213 02:16:37,360 --> 02:16:39,562 >> ALL RIGHT, GREAT. SO, YES, 3214 02:16:39,562 --> 02:16:41,831 MY NAME IS DR. JOSÉ I'M 3215 02:16:41,831 --> 02:16:43,333 PRESIDENT OF BOLD TYPE AND I'LL 3216 02:16:43,333 --> 02:16:46,703 BE PRESENTING ON A DEVICE TO 3217 02:16:46,703 --> 02:16:48,604 TREAT HIGH TONE PELVIC FLOOR 3218 02:16:48,604 --> 02:16:49,339 DYSFUNCTION IN WOMEN. THIS 3219 02:16:49,339 --> 02:16:52,041 RESEARCH IS FUNDED BY THE NIH 3220 02:16:52,041 --> 02:16:57,513 UNDER A PHASE ONE SPAR GRANT. A 3221 02:16:57,513 --> 02:16:58,681 BIT ABOUT THE LEADERSHIP TEAM SO 3222 02:16:58,681 --> 02:17:00,550 AS I MENTIONED ON THE PI MY 3223 02:17:00,550 --> 02:17:02,385 BACKGROUND IS IN ELECTRICAL 3224 02:17:02,385 --> 02:17:03,486 ENGINEERING I GOT ABOUT 20 YEARS 3225 02:17:03,486 --> 02:17:05,621 IN THE MEDICAL DEVICES SPACE. 3226 02:17:05,621 --> 02:17:08,858 VERY CLOSE COLLABORATOR ON THE 3227 02:17:08,858 --> 02:17:11,527 PROJECT AS DR. ERIN CAREY REALLY 3228 02:17:11,527 --> 02:17:14,097 THE INVENTOR OF THIS TECHNOLOGY. 3229 02:17:14,097 --> 02:17:15,698 THIS IS HER BRAINCHILD A FORMER 3230 02:17:15,698 --> 02:17:17,533 PRESIDENT OF THE INTERNATIONAL 3231 02:17:17,533 --> 02:17:18,901 PELVIC PAIN SOCIETY AND 3232 02:17:18,901 --> 02:17:21,904 PROFESSOR AT UNC. AND THEN ALSO 3233 02:17:21,904 --> 02:17:24,941 INVOLVED IN THIS PROJECT IS OUR 3234 02:17:24,941 --> 02:17:26,843 CHIEF SOFTWARE ARCHITECT 3235 02:17:26,843 --> 02:17:29,145 MOHAMMED, OUR CHIEF OPERATING 3236 02:17:29,145 --> 02:17:34,884 OFFICER ANDRES, AND JACKIE AND A 3237 02:17:34,884 --> 02:17:35,952 TEAM OF FIVE OTHER ENGINEERS 3238 02:17:35,952 --> 02:17:37,920 HAVE PARTICIPATED ON THIS 3239 02:17:37,920 --> 02:17:39,489 PROJECT. SO AS WE'VE BEEN 3240 02:17:39,489 --> 02:17:40,656 DISCUSSING OVER THE COURSE OF 3241 02:17:40,656 --> 02:17:42,992 THE DAY OUR -- THE DEVICE THAT 3242 02:17:42,992 --> 02:17:44,927 WE'RE DEVELOPING IS DESIGNED TO 3243 02:17:44,927 --> 02:17:46,396 TREAT PELVIC FLOOR DYSFUNCTION 3244 02:17:46,396 --> 02:17:52,568 AS A BROAD CATEGORY, PELVIC 3245 02:17:52,568 --> 02:17:54,637 FLOOR DYSFUNCTION CAN BE PAIN OR 3246 02:17:54,637 --> 02:17:59,275 INCONTINENCE CAUSED BY DID 3247 02:17:59,275 --> 02:18:01,577 MUSCLES IN THE PELVIC FLOOR 3248 02:18:01,577 --> 02:18:03,546 BEING TOO TIGHT OR TOO LOOSE. 3249 02:18:03,546 --> 02:18:05,848 AND WE ARE GOING TO TALK ABOUT 3250 02:18:05,848 --> 02:18:08,785 TOO TIGHT CAUSING CHRONIC PAIN. 3251 02:18:08,785 --> 02:18:11,354 IT'S A LARGE PROBLEM AS HAS BEEN 3252 02:18:11,354 --> 02:18:14,891 DISCUSSED THERE'S A VARIETY OF 3253 02:18:14,891 --> 02:18:16,926 SOURCES. THAT GIVE US METRICS 3254 02:18:16,926 --> 02:18:18,194 ABOUT HOW LARGE IT CAN BE BUT 3255 02:18:18,194 --> 02:18:20,997 IT'S ESTIMATED THAT 37 MILLION 3256 02:18:20,997 --> 02:18:22,832 IN THE U.S. SUFFER FROM 3257 02:18:22,832 --> 02:18:24,200 DYSFUNCTION OF WHICH ABOUT 30 3258 02:18:24,200 --> 02:18:26,169 MILLION WOULD BENEFIT FROM MY 3259 02:18:26,169 --> 02:18:28,971 OWE NATIONAL RELEASE THERAPY OF 3260 02:18:28,971 --> 02:18:30,406 THOSE 30 MILLION UNFORTUNATELY 3261 02:18:30,406 --> 02:18:31,841 ONLY ABOUT HALF SEEK TREATMENT. 3262 02:18:31,841 --> 02:18:36,946 AND OF THOSE 15 MILLION TEN 3263 02:18:36,946 --> 02:18:37,647 MILLION ACTUALLY INITIATE PELVIC 3264 02:18:37,647 --> 02:18:40,550 FLOOR THERAPY AND ABOUT FIVE 3265 02:18:40,550 --> 02:18:42,652 MILLION COMPLETE IT. AS WE 3266 02:18:42,652 --> 02:18:44,287 DISCUSSED OVER THE COURSE OF THE 3267 02:18:44,287 --> 02:18:46,522 DAY THE IMPACT OF CHRONIC PELVIC 3268 02:18:46,522 --> 02:18:49,759 PAIN ON PATIENTS' LIVES ARE 3269 02:18:49,759 --> 02:18:52,662 SUBSTANTIAL AND CAN BE THINGS 3270 02:18:52,662 --> 02:18:54,764 LIKE PREVENTING PHYSICAL 3271 02:18:54,764 --> 02:18:56,866 ACTIVITY, DECREASING SEXUAL 3272 02:18:56,866 --> 02:18:58,100 ACTIVITY, IT CAN RESULT IN POOR 3273 02:18:58,100 --> 02:19:00,203 RELATIONSHIP DYNAMICS, HIGHER 3274 02:19:00,203 --> 02:19:02,171 RATES OF ANXIETY AND HIGHER 3275 02:19:02,171 --> 02:19:04,407 RATES OF DEPRESSION. AT THE 3276 02:19:04,407 --> 02:19:08,778 START OF THIS PROJECT DR. CAREY 3277 02:19:08,778 --> 02:19:09,846 INTERVIEWED OVER A HUNDRED 3278 02:19:09,846 --> 02:19:11,214 PEOPLE AND WE HAVE A FEW QUOTES 3279 02:19:11,214 --> 02:19:12,648 HERE FROM SOME OF THOSE PATIENTS 3280 02:19:12,648 --> 02:19:16,953 THE TOP ONE HERE SHOWS PELVIC 3281 02:19:16,953 --> 02:19:27,497 FLOOR (READING). I THINK THIS 3282 02:19:31,834 --> 02:19:33,402 IS JUST PROBABLY RESONATES WITH 3283 02:19:33,402 --> 02:19:35,738 A LOT OF THE PARTICIPANTS TODAY 3284 02:19:35,738 --> 02:19:38,341 AND SOME OF THE PRESENTATIONS 3285 02:19:38,341 --> 02:19:41,544 GIVEN EARLIER. SO FIRST LINE OF 3286 02:19:41,544 --> 02:19:43,579 TREATMENT FOR THESE TYPES OF 3287 02:19:43,579 --> 02:19:46,983 CONDITIONS IS PELVIC FLOOR 3288 02:19:46,983 --> 02:19:48,351 PHYSICAL THERAPY AND A SESSION 3289 02:19:48,351 --> 02:19:52,722 OF PELVIC FLOOR PHYSICAL THERAPY 3290 02:19:52,722 --> 02:19:54,357 MIGHT INCLUDE PHYSICAL 3291 02:19:54,357 --> 02:19:57,093 EDUCATION, MANUAL THERAPY, AND 3292 02:19:57,093 --> 02:19:58,995 THEN ALSO SOFT TISSUE 3293 02:19:58,995 --> 02:19:59,795 MANIPULATION WITH MECHANICAL 3294 02:19:59,795 --> 02:20:01,764 WANDS SO HERE ON THE TOP RIGHT 3295 02:20:01,764 --> 02:20:05,501 IS AN EXAMPLE OF DR. CAREY 3296 02:20:05,501 --> 02:20:07,436 SHOWING WHAT A MECHANICAL WAND 3297 02:20:07,436 --> 02:20:10,172 WOULD LOOK LIKE AS ITS INSERTED 3298 02:20:10,172 --> 02:20:12,475 INTO THE PELVIC MUSCLES. 3299 02:20:12,475 --> 02:20:15,945 UNFORTUNATELY FEWER THAN 33% 3300 02:20:15,945 --> 02:20:18,047 WOMEN PRESCRIBED THIS COMPLETED 3301 02:20:18,047 --> 02:20:20,449 AND THE REASONS ARE VAR RID IF 3302 02:20:20,449 --> 02:20:22,652 WE LOOK AT THOSE BARRIERS AND 3303 02:20:22,652 --> 02:20:24,220 PUT THEM INTO TWO CATEGORIES. 3304 02:20:24,220 --> 02:20:27,056 ON THE LEFT WE SAY WHAT ARE THE 3305 02:20:27,056 --> 02:20:30,626 BARRIERS OF GOING TO A THERAPIST 3306 02:20:30,626 --> 02:20:33,930 THOSE INCLUDE TIME CONSTRAINTS, 3307 02:20:33,930 --> 02:20:35,231 TRAVEL ISSUES AND FEAR OF COURSE 3308 02:20:35,231 --> 02:20:37,633 IF WE COULD REDUCE THOSE 3309 02:20:37,633 --> 02:20:38,267 BARRIERS THAT WILL HELP DRIVE 3310 02:20:38,267 --> 02:20:39,735 GREATER ADHERENCE ON THE HOME 3311 02:20:39,735 --> 02:20:40,670 THERAPY SIDE OF THINGS HERE'S 3312 02:20:40,670 --> 02:20:42,471 JUST A FEW COMMENTS FROM SOME OF 3313 02:20:42,471 --> 02:20:43,539 THOSE PATIENTS WHO WERE 3314 02:20:43,539 --> 02:20:45,675 INTERVIEWED SO ONE PATIENT SAID, 3315 02:20:45,675 --> 02:20:47,777 I DON'T KNOW WHERE I AM DURING 3316 02:20:47,777 --> 02:20:48,678 INTERNAL WORK. THIS WOULD BE 3317 02:20:48,678 --> 02:20:51,514 WITH A MECHANICAL WAND. I'M NOT 3318 02:20:51,514 --> 02:20:54,517 SURE HOW MUCH PRESSURE I'M 3319 02:20:54,517 --> 02:20:57,086 PUTTING. I WAS WORRIED I WAS 3320 02:20:57,086 --> 02:20:58,788 GOING TO MAKE SOMETHING WORSE. 3321 02:20:58,788 --> 02:21:01,991 SO CLEARLY A LARGE BARRIER TO 3322 02:21:01,991 --> 02:21:03,426 PATIENTS DOING THIS TYPE OF 3323 02:21:03,426 --> 02:21:06,862 THERAPY AT HOME IS A LACK OF 3324 02:21:06,862 --> 02:21:08,965 UNDERSTANDING AND UNCERTAINTY 3325 02:21:08,965 --> 02:21:09,732 ABOUT WHETHER THEY'RE DOING 3326 02:21:09,732 --> 02:21:13,636 THE -- PERFORMING THE THERAPY 3327 02:21:13,636 --> 02:21:15,705 CORRECTLY. SO WE'VE ENVISIONED 3328 02:21:15,705 --> 02:21:18,074 AND PROPOSED AND ARE CURRENTLY 3329 02:21:18,074 --> 02:21:19,508 DEVELOPING A SYSTEM THAT WE 3330 02:21:19,508 --> 02:21:22,278 REFER TO AS A SMART WAND SYSTEM. 3331 02:21:22,278 --> 02:21:23,746 IT INCLUDES SMART MECHANICAL 3332 02:21:23,746 --> 02:21:27,550 WAND WITH A NUMBER OF SENSORS 3333 02:21:27,550 --> 02:21:30,686 INSIDE THAT INDICATES THROUGH 3334 02:21:30,686 --> 02:21:31,687 BLUETOOTH THROUGH THE PATIENT'S 3335 02:21:31,687 --> 02:21:32,922 CELL PHONE. DATA FROM THE 3336 02:21:32,922 --> 02:21:34,523 THERAPY AND THE INTERACTION CAN 3337 02:21:34,523 --> 02:21:35,858 BE SENT TO THE CLOUD THROUGH 3338 02:21:35,858 --> 02:21:37,593 WI-FI OR CELLULAR AND THEN ON 3339 02:21:37,593 --> 02:21:40,496 THE BACK END, WE PLAN TO DEVELOP 3340 02:21:40,496 --> 02:21:41,797 A PHYSICAL THERAPIST WEB 3341 02:21:41,797 --> 02:21:43,199 APPLICATION THAT THEY CAN USE TO 3342 02:21:43,199 --> 02:21:44,834 INTERFACE WITH THE PATIENT. OUR 3343 02:21:44,834 --> 02:21:48,237 GOAL IS NOT TO TRY TO REPLACE 3344 02:21:48,237 --> 02:21:49,639 PELVIC FLOOR PHYSICAL THERAPISTS 3345 02:21:49,639 --> 02:21:50,873 BUT TO SUPPORT THEM IN THEIR 3346 02:21:50,873 --> 02:21:53,175 TREATMENT OF PATIENTS AND TO 3347 02:21:53,175 --> 02:21:55,044 BRING SOME OF THAT THERAPY INTO 3348 02:21:55,044 --> 02:21:56,579 THE HOME WHILE STILL HAVING SOME 3349 02:21:56,579 --> 02:21:58,381 OF THE THERAPY BEING PERSON TO 3350 02:21:58,381 --> 02:21:59,749 PERSON. SO JUST TO GIVE YOU AN 3351 02:21:59,749 --> 02:22:01,550 IDEA OF HOW WE ENVISION THAT 3352 02:22:01,550 --> 02:22:03,419 RELATIONSHIP IF WE START WITH 3353 02:22:03,419 --> 02:22:07,356 THE VISIT TO THE PELVIC FLOOR PT 3354 02:22:07,356 --> 02:22:08,758 THE PATIENT WOULD GET AN 3355 02:22:08,758 --> 02:22:09,725 EXERCISE PLAN AND THEN THE 3356 02:22:09,725 --> 02:22:11,460 SYSTEM WOULD BE SET UP SO THE 3357 02:22:11,460 --> 02:22:13,529 DEVICE WOULD BE SET UP FOR THE 3358 02:22:13,529 --> 02:22:15,431 PARTICULAR PATIENT BY THE PT. 3359 02:22:15,431 --> 02:22:16,866 AND I'LL GIVE YOU AN IDEA OF HOW 3360 02:22:16,866 --> 02:22:18,167 THAT WORKS IN A COUPLE OF SLIDES 3361 02:22:18,167 --> 02:22:20,403 AND THEN THE PATIENT COULD DO 3362 02:22:20,403 --> 02:22:21,437 SOME OF THOSE EXERCISES AND SOME 3363 02:22:21,437 --> 02:22:25,074 OF THAT THERAPY AT HOME. THE 3364 02:22:25,074 --> 02:22:27,543 APP WOULD TRACK ADHERENCE AND 3365 02:22:27,543 --> 02:22:29,712 THEY'D BE ABLE TO ANSWER 3366 02:22:29,712 --> 02:22:30,346 SYMPTOMATIC REPORTS AND THEN 3367 02:22:30,346 --> 02:22:32,181 BACK TO THE PHYSICAL THERAPIST 3368 02:22:32,181 --> 02:22:33,949 THEY WOULD BE ABLE TO TRACK THE 3369 02:22:33,949 --> 02:22:36,686 ADHERENCE OF THE PATIENTS, 3370 02:22:36,686 --> 02:22:39,121 EVALUATE SYMPTOMATIC PROGRESS 3371 02:22:39,121 --> 02:22:40,656 REPORTS AND ADJUST THE EXERCISE 3372 02:22:40,656 --> 02:22:41,457 PLANS AND THERAPY AND 3373 02:22:41,457 --> 02:22:43,559 ESSENTIALLY REPROGRAM THE DEVICE 3374 02:22:43,559 --> 02:22:47,029 FOR THAT ANY THERAPY FOR THE 3375 02:22:47,029 --> 02:22:50,199 PATIENT. SO HERE'S THE GENERAL 3376 02:22:50,199 --> 02:22:52,968 OBJECTIVE SO TODAY, WHEN 3377 02:22:52,968 --> 02:22:55,504 PATIENTS ARE PRESCRIBED PHYSICAL 3378 02:22:55,504 --> 02:22:56,072 THERAPY THEY'RE PRESCRIBED 3379 02:22:56,072 --> 02:22:58,441 TWELVE WEEKS OF IN-PERSON WEEKLY 3380 02:22:58,441 --> 02:22:59,942 SESSIONS AT THE OFFICE AND THREE 3381 02:22:59,942 --> 02:23:01,377 DAYS A WEEK PATIENTS ARE 3382 02:23:01,377 --> 02:23:02,778 SUPPOSED TO DO SOME OF THESE 3383 02:23:02,778 --> 02:23:07,049 EXERCISES AT HOME. ABOUT 50% OF 3384 02:23:07,049 --> 02:23:10,986 PATIENTS MAY MAKE IT TO THE 3385 02:23:10,986 --> 02:23:11,754 SECOND SESSION. 3386 02:23:11,754 --> 02:23:16,192 AND AND ONLY SOME COMPLETE THESE 3387 02:23:16,192 --> 02:23:18,928 RATHER THAN HAVING TWELVE OF THE 3388 02:23:18,928 --> 02:23:23,165 VISIT TO THE PT YOU CAN REDUCE 3389 02:23:23,165 --> 02:23:24,767 THAT TO FOUR. AND THEN THE 3390 02:23:24,767 --> 02:23:28,337 OTHER EIGHT WOULD BE DONE VIA 3391 02:23:28,337 --> 02:23:31,340 TELEHEALTH WITH THE PHYSICAL 3392 02:23:31,340 --> 02:23:36,278 THERAPIST TO EVALUATE HOW THE 3393 02:23:36,278 --> 02:23:38,948 PATIENT IS DOING AND RATHER THAN 3394 02:23:38,948 --> 02:23:39,915 THREE SESSIONS UNGUIDE THEY CAN 3395 02:23:39,915 --> 02:23:42,651 DO IT IN A GUIDED FASHION. 3396 02:23:42,651 --> 02:23:44,220 WHAT WE EXPECT IS THAT THERE'LL 3397 02:23:44,220 --> 02:23:45,521 BE GREATER ADHERENCE BECAUSE OF 3398 02:23:45,521 --> 02:23:47,623 THE GUIDANCE AS PROVIDED BY THE 3399 02:23:47,623 --> 02:23:50,025 SMART WAND. THAT IS GOING TO BE 3400 02:23:50,025 --> 02:23:51,761 MORE COMFORTABLE AND MORE 3401 02:23:51,761 --> 02:23:53,295 CONVENIENT FOR THE PATIENT AND 3402 02:23:53,295 --> 02:23:59,335 THAT YOU'RE GOING TO GET... HAVE 3403 02:23:59,335 --> 02:24:00,936 AN OPPORTUNITY TO HAVE SUPPORT 3404 02:24:00,936 --> 02:24:03,139 SUCH AS EDUCATIONAL CONTENT IF 3405 02:24:03,139 --> 02:24:04,974 WE LOOK INSIDE THE WANT IT'S 3406 02:24:04,974 --> 02:24:06,542 FILLED WITH A VARIETY OF SENSORS 3407 02:24:06,542 --> 02:24:08,911 SO AT THE TIP OF THE WAND OR AT 3408 02:24:08,911 --> 02:24:16,519 THE SECTION THAT'S INSERTED INTO 3409 02:24:16,519 --> 02:24:19,555 THE VAGINA THERE'S SENSORS. 3410 02:24:19,555 --> 02:24:20,389 THERE'S A NUMBER OF STRAIN 3411 02:24:20,389 --> 02:24:22,858 GAUGES ON THE WAND THAT CAN 3412 02:24:22,858 --> 02:24:24,026 ACCURATELY MEASURE THE AMOUNT OF 3413 02:24:24,026 --> 02:24:25,694 FORCE BEING APPLIED AND THERE'S 3414 02:24:25,694 --> 02:24:28,097 ALSO A THREE AXIS ACCELEROMETER 3415 02:24:28,097 --> 02:24:29,899 THAT CAN MEASURE THE ROTATION OF 3416 02:24:29,899 --> 02:24:31,367 THE WAND AS IT'S INSERTED INTO 3417 02:24:31,367 --> 02:24:34,069 THE MUSCLES. OR INSERTED INTO 3418 02:24:34,069 --> 02:24:36,939 THE VAGINA. HERE'S A 3419 02:24:36,939 --> 02:24:38,107 PRELIMINARY COMMERCIAL APP 3420 02:24:38,107 --> 02:24:39,842 DESIGN SO THE IDEA HERE AS YOU 3421 02:24:39,842 --> 02:24:43,612 CAN SEE IS THAT THE PATIENT IS 3422 02:24:43,612 --> 02:24:49,418 GUIDED AS TO HOW TO INSERT THE 3423 02:24:49,418 --> 02:24:51,320 WAND AND HAVE THE PROPER AMOUNT 3424 02:24:51,320 --> 02:24:52,755 OF FORCE. THIS IS THE 3425 02:24:52,755 --> 02:24:53,989 COMMERCIAL VERSION OF THE APP 3426 02:24:53,989 --> 02:24:55,991 THAT WE'RE DEVELOPING AT THE 3427 02:24:55,991 --> 02:24:59,028 MOMENT WE'VE COMPLETED 3428 02:24:59,028 --> 02:24:59,895 DEVELOPMENT OF THE PRELIMINARY 3429 02:24:59,895 --> 02:25:03,332 PROPERTY PROTOTYPE AND WE'RE 3430 02:25:03,332 --> 02:25:06,435 DOING A HUMAN STUDIES. AND 3431 02:25:06,435 --> 02:25:07,937 WE'RE WORKING WITH TEN HEALTHY 3432 02:25:07,937 --> 02:25:09,738 CONTROLS AND I WILL SHOW YOU NOW 3433 02:25:09,738 --> 02:25:11,273 A DEMONSTRATION OF THE APP 3434 02:25:11,273 --> 02:25:12,942 THAT'S BEING USED IN THE 3435 02:25:12,942 --> 02:25:14,476 CLINICAL RESEARCH. 3436 02:25:14,476 --> 02:25:19,481 >> THIS IS A SMART WAND. IT CAN 3437 02:25:19,481 --> 02:25:22,852 MEASURE INSERTION DEPTH, ANGLING 3438 02:25:22,852 --> 02:25:27,022 OF ORIENTATION, AND PRESSURE 3439 02:25:27,022 --> 02:25:30,793 APPLIED. A PHYSICAL THERAPIST 3440 02:25:30,793 --> 02:25:32,194 WOULD INSERT THIS INTO THE 3441 02:25:32,194 --> 02:25:35,631 VAGINA TO THE DESIRED DEPTH, 3442 02:25:35,631 --> 02:25:37,399 POSITION IT AT THE RIGHT ANGLE 3443 02:25:37,399 --> 02:25:40,970 AND APPLY THE DESIRED AMOUNT OF 3444 02:25:40,970 --> 02:25:43,105 PRESSURE AND AT THAT POINT SET 3445 02:25:43,105 --> 02:25:44,940 IT. THIS WILL SET A TARGET FOR 3446 02:25:44,940 --> 02:25:46,508 THE PATIENT TO PLACE THE WAND IN 3447 02:25:46,508 --> 02:25:48,510 THE RIGHT PLACE FOR THE RIGHT 3448 02:25:48,510 --> 02:25:50,446 MUSCLE AND APPLY THE APPROPRIATE 3449 02:25:50,446 --> 02:25:52,014 AMOUNT OF PRESSURE IF WE GO TO 3450 02:25:52,014 --> 02:25:53,649 THE PATIENT SCREEN HERE THE 3451 02:25:53,649 --> 02:25:55,251 PATIENT IS SHOWN THE MUSCLE THAT 3452 02:25:55,251 --> 02:25:58,254 THEY WILL BE TREATING. WE CAN 3453 02:25:58,254 --> 02:26:00,723 SELECT START. AND NOW THE 3454 02:26:00,723 --> 02:26:03,592 PATIENT'S GOAL IS TO HAVE THE 3455 02:26:03,592 --> 02:26:05,661 CIRCLE REACH ITS TARGET DEPTH, 3456 02:26:05,661 --> 02:26:07,363 THE WAND BEING THE RIGHT ANGULAR 3457 02:26:07,363 --> 02:26:08,964 ORIENTATION AND THE AMOUNT OF 3458 02:26:08,964 --> 02:26:10,799 FORCE APPLIED TO BE AT THE RIGHT 3459 02:26:10,799 --> 02:26:12,668 LEVEL. ONCE THEY REACH THAT 3460 02:26:12,668 --> 02:26:15,771 TARGET, THEY HOLD THAT POSITION 3461 02:26:15,771 --> 02:26:24,113 FOR TEN SECONDS. AND NOW IT'S 3462 02:26:24,113 --> 02:26:26,749 COMPLET 3463 02:26:26,749 --> 02:26:27,383 COMPLETED. 3464 02:26:27,383 --> 02:26:29,818 >> ALL RIGHT. SO, AGAIN, DURING 3465 02:26:29,818 --> 02:26:31,987 THE PERIOD OF TIME OF STUDIES 3466 02:26:31,987 --> 02:26:33,923 THAT WE'RE CONDUCTING WE'RE 3467 02:26:33,923 --> 02:26:35,224 LOOKING AT SIX DIFFERENT 3468 02:26:35,224 --> 02:26:37,726 MUSCLES, THREE ON EITHER SIDE 3469 02:26:37,726 --> 02:26:39,595 AND, YOU KNOW, JUST TO GIVE YOU 3470 02:26:39,595 --> 02:26:42,665 A SENSE OF HOW THIS WORKS IN A 3471 02:26:42,665 --> 02:26:43,332 SLOWER FASHION WHEN THE PATIENT 3472 02:26:43,332 --> 02:26:46,035 FIRST GRABS THE WAND BEFORE 3473 02:26:46,035 --> 02:26:48,938 INSERTING IT THIS WOULD SHOW OFF 3474 02:26:48,938 --> 02:26:51,407 TARGET IF YOU WILL. AS THE 3475 02:26:51,407 --> 02:26:52,708 PATIENT INSERTS IT MORE DEEPLY 3476 02:26:52,708 --> 02:26:57,880 INTO THE VAGINA THE GRAY CIRCLE 3477 02:26:57,880 --> 02:27:00,482 REACHES THE TARGET AND TURNS 3478 02:27:00,482 --> 02:27:01,917 GREEN. THAT LETS THE PATIENT 3479 02:27:01,917 --> 02:27:03,752 KNOW THEY INSERTED IT 3480 02:27:03,752 --> 02:27:05,120 SUFFICIENTLY DEEP AND THEN THEY 3481 02:27:05,120 --> 02:27:07,156 HAVE TO HAVE THE BARS TO THE 3482 02:27:07,156 --> 02:27:11,327 DOTTED LINE. AS THEY ROTATE THE 3483 02:27:11,327 --> 02:27:13,128 WAND YOU WOULD BE ON TARGET AND 3484 02:27:13,128 --> 02:27:14,663 THEN YOU APPLY FOR SOME PRESSURE 3485 02:27:14,663 --> 02:27:16,465 AND THAT'S WHAT YOU SEE IN THE 3486 02:27:16,465 --> 02:27:19,001 PINK CIRCLE THAT THAT CIRCLE 3487 02:27:19,001 --> 02:27:22,137 RADIATES AND GROWS UNTIL IT 3488 02:27:22,137 --> 02:27:22,905 REACHES THE TARGET AMOUNT OF 3489 02:27:22,905 --> 02:27:26,675 FORCE AT THAT TIME THE COUNTDOWN 3490 02:27:26,675 --> 02:27:27,977 TRIGGERS AUTOMATICALLY AND AS 3491 02:27:27,977 --> 02:27:29,545 LONG AS THE PHYSICAL THERAPIST 3492 02:27:29,545 --> 02:27:33,449 SETS IT UP FOR THAT AMOUNT OF 3493 02:27:33,449 --> 02:27:35,050 PRESSURE THEY HOLD FOR THAT 3494 02:27:35,050 --> 02:27:36,819 PERIOD OF TIME. IN SUMMARY OUR 3495 02:27:36,819 --> 02:27:40,255 GOAL IS TO BRING PELVIC FLOOR 3496 02:27:40,255 --> 02:27:42,024 THERAPY AT HOME WHILE STILL 3497 02:27:42,024 --> 02:27:47,062 INCORPORATING THE WISDOM AND 3498 02:27:47,062 --> 02:27:52,968 SKILL OF PELVIC FLOOR PHYSICAL 3499 02:27:52,968 --> 02:27:53,268 THERAPISTS. 3500 02:27:53,268 --> 02:27:58,974 >> THANK YOU SO MUCH, DOCTOR. 3501 02:27:58,974 --> 02:28:03,812 IF YOU STOP SHARING YOUR SLIDE 3502 02:28:03,812 --> 02:28:11,420 YOU CAN SEE THE Q&A BOX. ANY 3503 02:28:11,420 --> 02:28:16,025 CONNECTION BETWEEN LINE AND 3504 02:28:16,025 --> 02:28:16,325 VULVODYNIA? 3505 02:28:16,325 --> 02:28:16,959 >> GOOD QUESTION AND HERE IS 3506 02:28:16,959 --> 02:28:18,927 WHAT I WILL GIVE YOU THE CAVEAT 3507 02:28:18,927 --> 02:28:20,829 OF WHAT MY KIDS LIKE TO SAY I AM 3508 02:28:20,829 --> 02:28:23,298 NOT A REAL DOCTOR I'M JUST AN 3509 02:28:23,298 --> 02:28:24,366 ENGINEERING PH.D. I HAVEN'T SEEN 3510 02:28:24,366 --> 02:28:29,071 THE WORK THAT WE'VE BEEN DOING 3511 02:28:29,071 --> 02:28:31,874 WITH DR. CAREY. OUR FOCUS HAS 3512 02:28:31,874 --> 02:28:34,009 BEEN WITH CHRONIC PELVIC PAIN. 3513 02:28:34,009 --> 02:28:36,011 YOU USE THE WAND LIKE A 3514 02:28:36,011 --> 02:28:37,813 MECHANICAL WAND BUT IT'S BEING 3515 02:28:37,813 --> 02:28:39,281 GUIDED BY A TARGET SET BY THE 3516 02:28:39,281 --> 02:28:42,251 PHYSICAL THERAPIST SO ANYWHERE 3517 02:28:42,251 --> 02:28:44,953 WHERE MAYA FASCIA RELEASE TYPE 3518 02:28:44,953 --> 02:28:46,055 OF THERAPY CAN BE HELPFUL THIS 3519 02:28:46,055 --> 02:28:52,895 CAN BE HELPFUL FOR PATIENTS. 3520 02:28:52,895 --> 02:28:54,329 >> THANK YOU, WE HAVE A 3521 02:28:54,329 --> 02:28:56,298 LOGISTICAL QUESTION IF THE 3522 02:28:56,298 --> 02:28:58,300 APPLICATION IS ON THE PHONE HOW 3523 02:28:58,300 --> 02:29:00,936 WILL USERS HOLD THEIR PHONE AND 3524 02:29:00,936 --> 02:29:02,738 USE THE WAND SIMULTANEOUSLY? 3525 02:29:02,738 --> 02:29:04,573 >> YES, THAT'S A GREAT QUESTION 3526 02:29:04,573 --> 02:29:05,541 AND YOU KNOW, WE'RE LOOKING AT 3527 02:29:05,541 --> 02:29:08,110 DIFFERENT OPTIONS THERE. WE 3528 02:29:08,110 --> 02:29:10,112 THINK, YOU KNOW, ONE POSSIBILITY 3529 02:29:10,112 --> 02:29:11,547 FOR, YOU KNOW, EITHER THE 3530 02:29:11,547 --> 02:29:15,317 PATIENT COULD ALSO USE A TAB 3531 02:29:15,317 --> 02:29:18,053 LAET -- TABLET OR A PHONE AND 3532 02:29:18,053 --> 02:29:20,089 MORE THAN LIKELY HAVE A STAND OR 3533 02:29:20,089 --> 02:29:21,857 SOMETHING. THE WAND CAN BE 3534 02:29:21,857 --> 02:29:23,959 OPERATED WITH ONE HAND BUT MORE 3535 02:29:23,959 --> 02:29:25,594 LIKELY IT'LL BE MORE COMFORTABLE 3536 02:29:25,594 --> 02:29:29,832 WITH TWO HANDS DID VICE HAS A 3537 02:29:29,832 --> 02:29:30,966 BUTTON ON IT AND THE PROTOCOL 3538 02:29:30,966 --> 02:29:32,968 THAT WAS SET UP FOR THE PATIENT 3539 02:29:32,968 --> 02:29:34,503 IS INITIATED THEY CAN GO FROM 3540 02:29:34,503 --> 02:29:35,804 ONE MUSCLE TO THE NEXT JUST BY 3541 02:29:35,804 --> 02:29:38,207 PRESSING THE BUTTON ON THE WAND. 3542 02:29:38,207 --> 02:29:39,675 SO THEY DON'T NEED TO INTERACT 3543 02:29:39,675 --> 02:29:42,377 WITH THE PHONE. THEY JUST NEED 3544 02:29:42,377 --> 02:29:43,645 IT FOR THE VISUAL FEEDBACK SO 3545 02:29:43,645 --> 02:29:46,115 THEY CAN PUT IT ON THE STAND AND 3546 02:29:46,115 --> 02:29:47,850 LOOK AT IT AS THEY'RE GOING 3547 02:29:47,850 --> 02:29:55,824 THROUGH THE DIFFERENT MUSCLES. 3548 02:29:55,824 --> 02:30:02,564 >> DR. GOLDSTEIN HAVE A 3549 02:30:02,564 --> 02:30:08,237 QUESTION. CAN YOU SEE THE CHAT. 3550 02:30:08,237 --> 02:30:11,974 >> I HAD THE Q&A OPEN. 3551 02:30:11,974 --> 02:30:15,344 >> WHY NOT TARGET PEW BOW RECTAL 3552 02:30:15,344 --> 02:30:18,147 LIS AND TRANSVERSE PERRY NIA. 3553 02:30:18,147 --> 02:30:20,516 >> THE IDEA OF THIS CAN BE USED 3554 02:30:20,516 --> 02:30:22,718 ON ANY PELVIC FLOOR MUSCLES FOR 3555 02:30:22,718 --> 02:30:25,187 THE PURPOSES OF A HUMAN STUDY 3556 02:30:25,187 --> 02:30:27,189 THIS IS A FIRST PROOF OF STUDY 3557 02:30:27,189 --> 02:30:28,757 CONCEPT. WE SELECTED THREE 3558 02:30:28,757 --> 02:30:29,558 MUSCLES BUT ABSOLUTELY, ANY OF 3559 02:30:29,558 --> 02:30:32,895 THE MUSCLES THAT CAN BE REACHED 3560 02:30:32,895 --> 02:30:34,897 INTRAVAGINALLY ARE GOOD 3561 02:30:34,897 --> 02:30:37,366 CANDIDATES FOR PELVIC FLOOR 3562 02:30:37,366 --> 02:30:38,367 PHYSICAL THERAPY AND THE SMART 3563 02:30:38,367 --> 02:30:40,936 WAND WOULD CERTAINLY BE OF USE 3564 02:30:40,936 --> 02:30:43,539 FOR THAT. 3565 02:30:43,539 --> 02:30:47,476 >> OKAY. 3566 02:30:47,476 --> 02:30:49,878 >> THANK YOU SO MUCH, IT'S 3:55 3567 02:30:49,878 --> 02:30:52,548 SO WE NEED TO MOVE ON. THANK 3568 02:30:52,548 --> 02:30:53,715 YOU SO MUCH DOCTOR. 3569 02:30:53,715 --> 02:30:53,782 THANK YOU VERY MUCH. 3570 02:30:53,782 --> 02:30:57,019 WE HAVE TWO FDA SPEAKERS THE 3571 02:30:57,019 --> 02:30:59,588 FIRST SPEAKER IS DR. REGINALD 3572 02:30:59,588 --> 02:31:03,158 AVERY. DR. AVERY CAN YOU SHARE 3573 02:31:03,158 --> 02:31:13,950 YOUR SLIDES? (AUDIO CUTTING 3574 02:31:13,950 --> 02:31:17,497 OUT). AT THE FDA. AND PRIOR TO 3575 02:31:17,497 --> 02:31:19,766 HIS ROLE AS A TEAM LEAD HE WAS A 3576 02:31:19,766 --> 02:31:23,069 LEAD REVIEWER IN THE OBSTETRICAL 3577 02:31:23,069 --> 02:31:23,836 AND REPRODUCTIVE HEALTH DEVICES 3578 02:31:23,836 --> 02:31:34,380 TEAM. DR. AVERY, THE FLOOR IS 3579 02:31:35,381 --> 02:31:35,515 YOURS. 3580 02:31:35,515 --> 02:31:36,449 >> THANK YOU, HOPEFULLY YOU CAN 3581 02:31:36,449 --> 02:31:37,383 SEE MY SLIDES. 3582 02:31:37,383 --> 02:31:41,220 >> YES. 3583 02:31:41,220 --> 02:31:42,855 >> FWRAECHLT THA GREAT THANK YO 3584 02:31:42,855 --> 02:31:44,590 INTRODUCTION AND THE INVITATION. 3585 02:31:44,590 --> 02:31:46,059 MY NAME IS REGINALD AVERY AND 3586 02:31:46,059 --> 02:31:48,628 I'M THE TEAM LEAD FOR THE 3587 02:31:48,628 --> 02:31:49,962 GYNECOLOGICAL DEVICES TEAM IN 3588 02:31:49,962 --> 02:31:53,199 THE CENTER FOR DEVICES IN 3589 02:31:53,199 --> 02:31:55,868 RADIOLOGICAL HEALTH OR CDRH IN 3590 02:31:55,868 --> 02:31:57,203 FDA. 3591 02:31:57,203 --> 02:31:59,439 IN THIS PRESENTATION, I WILL TRY 3592 02:31:59,439 --> 02:32:01,774 TO BRIEFLY OVERVIEW THAT'S THE 3593 02:32:01,774 --> 02:32:03,376 FDA ORGANIZATION AND AGENCY 3594 02:32:03,376 --> 02:32:06,279 AUTHORITIES FOR MEDICAL DEVICES, 3595 02:32:06,279 --> 02:32:08,448 SURPRISE THE TOTAL PRODUCT LIFE 3596 02:32:08,448 --> 02:32:11,050 CYCLE AND HOW MEDICAL DEVICES 3597 02:32:11,050 --> 02:32:14,253 REVIEW AND REGULATED BY FDA. 3598 02:32:14,253 --> 02:32:18,091 I'LL FOCUS ON PREMARKET 3599 02:32:18,091 --> 02:32:21,861 ACTIVITIES BUT CAN'T DISCUSS 3600 02:32:21,861 --> 02:32:23,463 POSTMARKET ACTIVITIES AFTER MY 3601 02:32:23,463 --> 02:32:25,298 PRESENTATION IF PEOPLE HAVE 3602 02:32:25,298 --> 02:32:29,902 QUESTIONS. THE FDA IS A 3603 02:32:29,902 --> 02:32:31,437 REGULATORY AGENCY WITH THE 3604 02:32:31,437 --> 02:32:32,572 MISSION TO PROTECT AND PROMOTE 3605 02:32:32,572 --> 02:32:35,575 THE PUBLIC HEALTH THE STATUTES 3606 02:32:35,575 --> 02:32:36,209 AND REGULATIONS LISTED ON THIS 3607 02:32:36,209 --> 02:32:37,910 SLIDE ARE SOME OF THE LAWS THAT 3608 02:32:37,910 --> 02:32:42,915 GIVE FDA ITS AUTHORITIES. AND 3609 02:32:42,915 --> 02:32:44,617 RESPONSIBILITIES BUT ADDITIONAL 3610 02:32:44,617 --> 02:32:47,086 REQUIREMENTS AND DEVICE 3611 02:32:47,086 --> 02:32:47,887 CLASSIFICATION INFORMATION ARE 3612 02:32:47,887 --> 02:32:51,524 ALSO OUTLINED IN TITLE II 1 OF 3613 02:32:51,524 --> 02:32:54,527 THE CODE OF FEDERAL REGULATIONS. 3614 02:32:54,527 --> 02:32:56,562 FDA IS ORGANIZED INTO DIFFERENT 3615 02:32:56,562 --> 02:32:58,731 CENTERS BASED ON MEDICAL PRODUCT 3616 02:32:58,731 --> 02:32:59,465 REVIEW AREA. 3617 02:32:59,465 --> 02:33:00,967 THE CENTERS INCLUDE THE CENTER 3618 02:33:00,967 --> 02:33:03,836 FOR DEVICES AND RADIOLOGICAL 3619 02:33:03,836 --> 02:33:07,273 HEALTH OR CDRH WHICH IS WHERE I 3620 02:33:07,273 --> 02:33:10,877 WORK. WITHIN CDRH THERE'S THE 3621 02:33:10,877 --> 02:33:12,078 OFFICE OF PRODUCTS, EVALUATION 3622 02:33:12,078 --> 02:33:16,115 AND QUALITY OR OPEC. AND THAT 3623 02:33:16,115 --> 02:33:17,884 IS RESPONSIBILITY FOR THE TOTAL 3624 02:33:17,884 --> 02:33:19,152 PRODUCT LIFE CYCLE REVIEW OF 3625 02:33:19,152 --> 02:33:20,520 MEDICAL DEVICES. 3626 02:33:20,520 --> 02:33:24,056 OUR ROLE IN THIS OFFICE INCLUDES 3627 02:33:24,056 --> 02:33:25,358 SUBMISSION REVIEWS TO GET 3628 02:33:25,358 --> 02:33:27,760 MEDICAL DEVICES ON THE MARKET AS 3629 02:33:27,760 --> 02:33:29,695 WELL AS ACTIVITIES TO MONITOR 3630 02:33:29,695 --> 02:33:32,165 COMPANIES AND REVIEW INFECTION 3631 02:33:32,165 --> 02:33:34,000 FINDINGS FOR COMPLIANCE ONCE 3632 02:33:34,000 --> 02:33:38,204 COMPANIES HAVE DEVICES ON THE 3633 02:33:38,204 --> 02:33:40,039 MARKET. LASTLY, WE'LL LOOK AT 3634 02:33:40,039 --> 02:33:42,909 WHERE MY TEAM IS HOUSED WHICH IS 3635 02:33:42,909 --> 02:33:45,478 WITHIN THE OFFICES OF HEALTH 3636 02:33:45,478 --> 02:33:50,116 TECHNOLOGIES OR OHTS IN OPEQ 3637 02:33:50,116 --> 02:33:52,084 THERE ARE DIFFERENT OHTS AND 3638 02:33:52,084 --> 02:33:54,086 THEY ARE SEPARATED BASED ON 3639 02:33:54,086 --> 02:33:56,255 CLINICAL AND ANATOMICAL AREAS MY 3640 02:33:56,255 --> 02:33:58,791 TEAM THE GYNECOLOGICAL AND 3641 02:33:58,791 --> 02:34:03,729 SURGICAL DEVICES TEAM IS PART OF 3642 02:34:03,729 --> 02:34:06,799 OHT3 WHICH IS THE OFFICE OF 3643 02:34:06,799 --> 02:34:09,735 GASTRO RENAL, OBGYN, GENERAL 3644 02:34:09,735 --> 02:34:12,071 HOSPITAL AND UROLOGY DEVICES AND 3645 02:34:12,071 --> 02:34:14,240 IS PART OF THE GYNECOLOGY AND 3646 02:34:14,240 --> 02:34:16,509 NEUROLOGY DEVICES. THE DIVISION 3647 02:34:16,509 --> 02:34:19,512 I WORK IN ALSO INCLUDES 3648 02:34:19,512 --> 02:34:21,314 OBSTETRIC AND REPRODUCTIVE 3649 02:34:21,314 --> 02:34:23,282 HEALTH DEVICES LIKE CONDOMS AND 3650 02:34:23,282 --> 02:34:25,618 MATERNAL FETAL MONITORS, MALE 3651 02:34:25,618 --> 02:34:31,724 AND FEMAAILURE ROLLING DEVICES.N 3652 02:34:31,724 --> 02:34:36,162 THIS SLIDE ARE A FEW DEVICES 3653 02:34:36,162 --> 02:34:38,331 REVIEWED BY THE GYNECOLOGICAL 3654 02:34:38,331 --> 02:34:38,865 TEAMS. 3655 02:34:38,865 --> 02:34:41,667 RANGING FROM SURGICAL TOOLS, 3656 02:34:41,667 --> 02:34:43,035 DEVICES USED FOR ROUTINE 3657 02:34:43,035 --> 02:34:45,137 GYNECOLOGY VISITS AND 3658 02:34:45,137 --> 02:34:46,873 OVER-THE-COUNTER PRODUCTS. FOR 3659 02:34:46,873 --> 02:34:49,141 TODAY'S PRESENTATION, I WILL 3660 02:34:49,141 --> 02:34:50,810 DISCUSS THE THREE MAIN 3661 02:34:50,810 --> 02:34:55,548 COMPONENTS THAT TLPC PREMARKET, 3662 02:34:55,548 --> 02:34:57,283 POSTMARKET BUT I WILL FOCUS ON 3663 02:34:57,283 --> 02:34:59,252 THE PREMARKET ACTIVITIES THE 3664 02:34:59,252 --> 02:35:01,654 REVIEW TEAMS WHICH INCLUDE 3665 02:35:01,654 --> 02:35:07,493 ENGINEERS, CLINICIANS, NURSES, 3666 02:35:07,493 --> 02:35:11,230 MICROBIOLOGISTS, THINK OF TPLC 3667 02:35:11,230 --> 02:35:13,199 HAS A HOLISTIC PROCESS WORKING 3668 02:35:13,199 --> 02:35:15,902 IN TANDEM AND NOT IN ISOLATION 3669 02:35:15,902 --> 02:35:17,103 TO HELP ENSURE THAT THERE ARE 3670 02:35:17,103 --> 02:35:19,839 SAFE AND EFFECTIVE MEDICAL 3671 02:35:19,839 --> 02:35:22,842 DEVICES ON THE MARKET. BEFORE 3672 02:35:22,842 --> 02:35:26,746 DISCUSSING THE PREMARKET WORK, I 3673 02:35:26,746 --> 02:35:27,780 WOULD LIKE TO PROVIDE A 3674 02:35:27,780 --> 02:35:30,917 DEFINITION OF A MEDICAL DEVICE. 3675 02:35:30,917 --> 02:35:33,519 THE OHTS ARE RESPONSIBLE FOR 3676 02:35:33,519 --> 02:35:34,720 REVIEWING MEDICAL PRODUCTS THAT 3677 02:35:34,720 --> 02:35:36,956 MEET THE DEFINITION OF A MEDICAL 3678 02:35:36,956 --> 02:35:40,426 DEVICE AND THAT'S SHOWN ON THIS 3679 02:35:40,426 --> 02:35:41,994 SLIDE. THIS LANGUAGE IS FROM 3680 02:35:41,994 --> 02:35:44,063 THE FOOD, DRUG AND COSMETIC ACT 3681 02:35:44,063 --> 02:35:47,700 AND IT NOTES THAT A DEVICE IS AN 3682 02:35:47,700 --> 02:35:50,503 INSTRUMENT, APPARATUS, 3683 02:35:50,503 --> 02:35:53,272 IMPLEMENT, ET CETERA, WHICH IS 3684 02:35:53,272 --> 02:35:56,776 INTENDED FOR USE IN A DIAGNOSIS 3685 02:35:56,776 --> 02:35:58,110 OF DISEASE OR OTHER CONDITIONS 3686 02:35:58,110 --> 02:36:01,814 OR IN THE CURE OR PREVENTION OF 3687 02:36:01,814 --> 02:36:03,182 DISEASE. OR IS INTENDED TO 3688 02:36:03,182 --> 02:36:05,051 AFFECT THE STRUCTURE OR ANY 3689 02:36:05,051 --> 02:36:07,987 FUNCTION OF THE BODY IN WHICH 3690 02:36:07,987 --> 02:36:11,257 DOES NOT ACHIEVE AS PRIMARY 3691 02:36:11,257 --> 02:36:12,525 INTENDED PURPOSES THROUGH 3692 02:36:12,525 --> 02:36:15,227 CHEMICAL ACTION. SO THE PIECES 3693 02:36:15,227 --> 02:36:17,263 OF THAT DEFINITION THAT I JUST 3694 02:36:17,263 --> 02:36:19,865 READ HELP ADDRESS THE INTENDED 3695 02:36:19,865 --> 02:36:22,301 USE IN PART B AND THE MECHANISM 3696 02:36:22,301 --> 02:36:25,304 OF ACTION PART C OF A MEDICAL 3697 02:36:25,304 --> 02:36:26,305 DEVICE. AND IT HELPS 3698 02:36:26,305 --> 02:36:27,840 DISTINGUISH DEVICES FROM DRUGS 3699 02:36:27,840 --> 02:36:31,744 OR BIOLOGICS. MEDICAL DEVICES 3700 02:36:31,744 --> 02:36:33,779 ALSO INCLUDE CERTAIN SOFTWARE 3701 02:36:33,779 --> 02:36:36,716 FUNCTIONS, INCLUDING 3702 02:36:36,716 --> 02:36:37,616 SOFTWARE-BASED MOBILE, MEDICAL 3703 02:36:37,616 --> 02:36:38,951 APPLICATIONS THAT MEET THE 3704 02:36:38,951 --> 02:36:45,424 DEFINITION OF A DEVICE. THERE 3705 02:36:45,424 --> 02:36:53,799 ARE 3 CLASSES OF MEDICAL DEVICES 3706 02:36:53,799 --> 02:36:55,868 AND THEY'RE PLACED BASED ON 3707 02:36:55,868 --> 02:36:59,939 THEIR RISK LEVEL AND THE 3708 02:36:59,939 --> 02:37:02,541 REGULATORY NEEDED FOR SAFETY AND 3709 02:37:02,541 --> 02:37:03,142 EFFECTIVENESS. I WILL GO 3710 02:37:03,142 --> 02:37:05,911 THROUGH EACH OF THE CLASSES 3711 02:37:05,911 --> 02:37:08,014 SHORTLY. CLASS ONE DEVICES ARE 3712 02:37:08,014 --> 02:37:10,249 LOW TO MODERATE RISK. AND 3713 02:37:10,249 --> 02:37:12,952 GENERAL CONTROLS ARE NEEDED TO 3714 02:37:12,952 --> 02:37:14,086 PROVIDE A REASONABLE ASSURANCE 3715 02:37:14,086 --> 02:37:16,489 OF SAFETY AND EFFECTIVENESS. 3716 02:37:16,489 --> 02:37:18,991 SOME EXAMPLES OF THOSE GENERAL 3717 02:37:18,991 --> 02:37:20,693 CONTROLS ARE REGISTRATION AND 3718 02:37:20,693 --> 02:37:22,962 LISTENING REQUIREMENTS. 3719 02:37:22,962 --> 02:37:24,063 RECORDKEEPING. AND MEDICAL 3720 02:37:24,063 --> 02:37:26,966 DEVICE REPORTING REQUIREMENTS. 3721 02:37:26,966 --> 02:37:30,469 CLASS ONE DEVICES MAY BE EXEMPT 3722 02:37:30,469 --> 02:37:32,638 FROM 510K SUBMISSIONS WHICH 3723 02:37:32,638 --> 02:37:35,408 WE'LL OVERVIEW SHORTLY. NEXT 3724 02:37:35,408 --> 02:37:37,977 CLASS TWO DEVICES ARE MODERATE 3725 02:37:37,977 --> 02:37:39,678 TO HIGH RISK. AND GENERAL AND 3726 02:37:39,678 --> 02:37:42,448 SPECIAL CONTROLS. ARE NEEDED TO 3727 02:37:42,448 --> 02:37:43,315 PROVIDE THAT REASONABLE 3728 02:37:43,315 --> 02:37:46,018 ASSURANCE OF SAFETY AND 3729 02:37:46,018 --> 02:37:47,887 EFFECTIVENESS. SPECIAL CONTROLS 3730 02:37:47,887 --> 02:37:49,889 ARE USUALLY DEVICE-SPECIFIC 3731 02:37:49,889 --> 02:37:53,159 REQUIREMENTS. AND MAY INCLUDE 3732 02:37:53,159 --> 02:37:54,226 NON-CLINICAL TEST REQUIREMENTS 3733 02:37:54,226 --> 02:37:56,162 AS WELL AS LABELING 3734 02:37:56,162 --> 02:37:58,564 REQUIREMENTS. CLASS TWO DEVICES 3735 02:37:58,564 --> 02:38:03,736 TYPICALLY NEED A 510K TO BE 3736 02:38:03,736 --> 02:38:07,006 AUTHORIZED FOR MARKETING. DE 3737 02:38:07,006 --> 02:38:08,140 NOVOS ARE ANOTHER TYPE OF 3738 02:38:08,140 --> 02:38:10,643 SUBMISSION THAT CAN BE USED TO 3739 02:38:10,643 --> 02:38:13,412 MARKET CERTAIN CLASS TWO DEVICES 3740 02:38:13,412 --> 02:38:15,981 AND I'LL OVERVIEW WHAT A DE NOVO 3741 02:38:15,981 --> 02:38:20,786 ENTAILS IN A LATER SLIDE. LAST 3742 02:38:20,786 --> 02:38:22,755 CLASS THREE DEVICES ARE ANY HIGH 3743 02:38:22,755 --> 02:38:25,124 RISK DEVICES. THESE REQUIRE 3744 02:38:25,124 --> 02:38:27,860 GENERAL CONTROLS AND PREMARKET 3745 02:38:27,860 --> 02:38:29,728 APPROVAL TO PROVIDE THAT 3746 02:38:29,728 --> 02:38:31,330 REASONABLE ASSURANCE OF SAFETY 3747 02:38:31,330 --> 02:38:34,366 AND EFFECTIVENESS. AND 3748 02:38:34,366 --> 02:38:36,735 ACCORDINGLY A PMA IS THE 3749 02:38:36,735 --> 02:38:38,904 ASSOCIATED PREMARKET SUBMISSION 3750 02:38:38,904 --> 02:38:40,106 TYPE. ON EACH SLIDE FOR 3751 02:38:40,106 --> 02:38:42,708 PREMARKET REVIEWS. I HAVE 3752 02:38:42,708 --> 02:38:45,044 INCLUDED A FEW RESOURCES THAT 3753 02:38:45,044 --> 02:38:47,279 MAY HELP A MANUFACTURER OR 3754 02:38:47,279 --> 02:38:50,149 RESEARCHER UNDERSTAND THE 3755 02:38:50,149 --> 02:38:51,383 PREMARKET TOPIC. AND ONE 3756 02:38:51,383 --> 02:38:53,018 RESOURCE THAT I DO WANT TO 3757 02:38:53,018 --> 02:38:59,125 HIGHLIGHT IS THE PRESUBMISSION 3758 02:38:59,125 --> 02:39:01,894 PROGRAM. SO THIS PROGRAM IS A 3759 02:39:01,894 --> 02:39:04,163 COMMONLY USED APPROACH FOR 3760 02:39:04,163 --> 02:39:06,632 SPONSORS, RESEARCHERS, 3761 02:39:06,632 --> 02:39:08,767 INVESTIGATORS OR MANUFACTURERS 3762 02:39:08,767 --> 02:39:10,503 TO BEGIN OR CONTINUE TO 3763 02:39:10,503 --> 02:39:12,438 COMMUNICATE WITH FDA REVIEW 3764 02:39:12,438 --> 02:39:15,007 TEAMS TO HELP FACILITATE 3765 02:39:15,007 --> 02:39:17,143 BRINGING A DEVICE TO A MARKET 3766 02:39:17,143 --> 02:39:19,245 THE SUBMISSIONS ARE FREE AND ARE 3767 02:39:19,245 --> 02:39:20,846 USED TO RECEIVE FEEDBACK ON A 3768 02:39:20,846 --> 02:39:23,849 REGULATORY STRATEGY FOR A 3769 02:39:23,849 --> 02:39:24,583 DEVICE. APPROPRIATE 3770 02:39:24,583 --> 02:39:27,286 NON-CLINICAL TEST PLANS. ANIMAL 3771 02:39:27,286 --> 02:39:29,722 TESTING CLINICAL STUDY PROTOCOLS 3772 02:39:29,722 --> 02:39:31,824 SOR TO DISCUSS ANY DEFICIENCIES 3773 02:39:31,824 --> 02:39:34,126 THAT ACCOMPANY RECEIVED AS PART 3774 02:39:34,126 --> 02:39:37,396 OF A PREMARKET REVIEW. 3775 02:39:37,396 --> 02:39:39,565 THERE IS NO RIGHT TIME TO SUBMIT 3776 02:39:39,565 --> 02:39:42,268 A PRESUBMISSION. IT CAN BE 3777 02:39:42,268 --> 02:39:43,502 WHILE YOU'RE IN THE IDEA STAGE 3778 02:39:43,502 --> 02:39:45,905 OR WHEN YOU'RE CLOSER TO 3779 02:39:45,905 --> 02:39:49,375 FINALIZING YOUR DEVICE DESIGN. 3780 02:39:49,375 --> 02:39:51,377 YOU CAN SUBMIT MOST OF THE 3781 02:39:51,377 --> 02:39:52,344 PRESUBMISSIONS, THERE'S NO LIMIT 3782 02:39:52,344 --> 02:39:55,981 ON THE AMOUNT AND WE REALLY DO 3783 02:39:55,981 --> 02:39:57,049 THINK THAT THIS PROGRAM HELPS 3784 02:39:57,049 --> 02:40:02,054 ENSURE THAT FDA AND SPONSORS ARE 3785 02:40:02,054 --> 02:40:03,522 ALIGNED ON WHAT THE EXPECTATIONS 3786 02:40:03,522 --> 02:40:05,224 WILL BE ON THE PREMARKET 3787 02:40:05,224 --> 02:40:06,525 SUBMISSION BEFORE THEY GET TO 3788 02:40:06,525 --> 02:40:10,229 THAT POINT OF SUBMITTING 3789 02:40:10,229 --> 02:40:14,400 WHATEVER THEIR 510K DE NOVO OR 3790 02:40:14,400 --> 02:40:16,335 PMA. SO IF YOU ALREADY KNOW OR 3791 02:40:16,335 --> 02:40:18,904 WERE INFORMED BY THE REVIEW TEAM 3792 02:40:18,904 --> 02:40:21,707 THAT CLINICAL DATA WILL BE 3793 02:40:21,707 --> 02:40:25,177 NECESSARY TO SUPPORT A MARKETING 3794 02:40:25,177 --> 02:40:27,179 AUTHORIZATION YOU MAY NEED TO 3795 02:40:27,179 --> 02:40:31,717 SUBMIT A DEVICE EXEMPTION OR IED 3796 02:40:31,717 --> 02:40:36,121 TO STUDY A SIGNIFICANT DEVICE IN 3797 02:40:36,121 --> 02:40:38,224 THE UNITED STATES YOU MUST 3798 02:40:38,224 --> 02:40:41,026 SUBMIT AN IDE FOR APPROVAL. 3799 02:40:41,026 --> 02:40:43,195 THIS CAN BE A FIRST IN HUMAN 3800 02:40:43,195 --> 02:40:44,663 STUDY, AS AN EARLY FEASIBILITY 3801 02:40:44,663 --> 02:40:47,132 STUDY A PILOT STUDY OR YOUR FULL 3802 02:40:47,132 --> 02:40:49,201 PIVOTAL STUDY WHICH IS INTENDED 3803 02:40:49,201 --> 02:40:53,138 TO SUPPORT DEVICE SAFETY EFFECT 3804 02:40:53,138 --> 02:41:03,515 ANDIVENESS. FDA WILL DETERMINE 3805 02:41:03,515 --> 02:41:05,718 WHETHER THESE SUPPORT THE SAFE 3806 02:41:05,718 --> 02:41:10,155 USE OF THE DEVICE IN THE 3807 02:41:10,155 --> 02:41:20,699 INVESTIGATIONAL STUDY. FDA WILL 3808 02:41:22,835 --> 02:41:28,540 ALSO SUPPORT THIS THAT -- 3809 02:41:28,540 --> 02:41:30,142 EXAMPLES OF THESE CONSIDERATIONS 3810 02:41:30,142 --> 02:41:31,777 THAT YOU MAY RECEIVE INCLUDE A 3811 02:41:31,777 --> 02:41:33,279 MORE APPROPRIATE PRIMARY END 3812 02:41:33,279 --> 02:41:35,748 POINT OR RECOMMENDATION TO 3813 02:41:35,748 --> 02:41:36,882 PROVIDE ADDITIONAL BENCH TESTING 3814 02:41:36,882 --> 02:41:41,720 TO SUPPORT DEVICE EFFECTIVENESS 3815 02:41:41,720 --> 02:41:43,889 IN MARKETING SUBMISSION. NOW 3816 02:41:43,889 --> 02:41:46,759 ONCE YOU HAVE ALL OF THE 3817 02:41:46,759 --> 02:41:48,360 NON-CLINICAL AND CLINICAL DATA 3818 02:41:48,360 --> 02:41:50,863 AS WELL AS THE PROPOSED LABELING 3819 02:41:50,863 --> 02:41:51,597 YOU BELIEVE ARE NECESSARY TO 3820 02:41:51,597 --> 02:41:54,066 SUPPORT A MARKETING 3821 02:41:54,066 --> 02:41:56,435 AUTHORIZATION, YOU'LL SUBMIT 3822 02:41:56,435 --> 02:42:03,909 YOUR MARKETING APPLICATION DO 3823 02:42:03,909 --> 02:42:07,313 NOVO, 510 (K) ARE THE MOST 3824 02:42:07,313 --> 02:42:14,720 COMMON. AND SUBMISSION TYPES 3825 02:42:14,720 --> 02:42:17,523 ARE SUBJECT TO A FEE. FIRST, 3826 02:42:17,523 --> 02:42:21,293 THE 510K WHICH IS MOST COMMON 3827 02:42:21,293 --> 02:42:23,395 PATH WEI FOR GUIDELINE KOE 3828 02:42:23,395 --> 02:42:25,831 LOGICAL DEVICE TO RECEIVE 3829 02:42:25,831 --> 02:42:26,732 MARKETING AUTHORIZATION. 3830 02:42:26,732 --> 02:42:31,403 THE REGULATORY FRAMEWORK 4510K 3831 02:42:31,403 --> 02:42:34,373 IS TO DEMONSTRATE AS SAFE AND AS 3832 02:42:34,373 --> 02:42:37,810 EFFECTIVE AS A LEGALLY MARKETED 3833 02:42:37,810 --> 02:42:39,978 PREDICATE DEVICE OR THAT THE 3834 02:42:39,978 --> 02:42:43,382 SUBJECT AND PREDICATE DEVICE ARE 3835 02:42:43,382 --> 02:42:44,016 SUBSTANTIALLY EQUIVALENT. AND 3836 02:42:44,016 --> 02:42:46,952 WHAT MAKES A DEVICE 3837 02:42:46,952 --> 02:42:48,487 SUBSTANTIALLY EQUIVALENT IS WHEN 3838 02:42:48,487 --> 02:42:51,790 IT HAS THE SAME INTENDED USE AS 3839 02:42:51,790 --> 02:42:53,459 THE PREDICATE DEVICE. IT HAS 3840 02:42:53,459 --> 02:42:56,929 THE SAME TECHNOLOGICAL 3841 02:42:56,929 --> 02:42:57,830 CHARACTERISTICS AS THE PREDICATE 3842 02:42:57,830 --> 02:42:59,965 DEVICE OR IF THERE ARE 3843 02:42:59,965 --> 02:43:01,300 DIFFERENCES, THOSE DIFFERENCES 3844 02:43:01,300 --> 02:43:04,603 DO NOT RAISE DIFFERENT QUESTIONS 3845 02:43:04,603 --> 02:43:10,676 OF SAFETY OF EFFECTIVENESS AND 3846 02:43:10,676 --> 02:43:13,545 THEY HELP DEMONSTRATE THAT THE 3847 02:43:13,545 --> 02:43:19,985 DEVICE IS AS SAFI SAFE EFFECTIV 3848 02:43:19,985 --> 02:43:22,087 THE PREDICATE DEVICE. DE NOVOS 3849 02:43:22,087 --> 02:43:28,260 ALLOW ES FDA TO CLASSIFY LOW 3850 02:43:28,260 --> 02:43:31,964 RISK DEVICES THAT DO NOT HAVE A 3851 02:43:31,964 --> 02:43:33,799 MARKETING PREDICATE PART OF THE 3852 02:43:33,799 --> 02:43:35,768 TEAM'S WORK IS TO CONFIRM THERE 3853 02:43:35,768 --> 02:43:39,271 IS NO AVAILABLE REGULATION OR 3854 02:43:39,271 --> 02:43:39,938 PREDICATE ALREADY AVAILABLE FOR 3855 02:43:39,938 --> 02:43:43,976 THE DEVICE BASED ON ITS INTENDED 3856 02:43:43,976 --> 02:43:46,745 USE AND TECHNOLOGICAL 3857 02:43:46,745 --> 02:43:47,913 CHARACTERISTICS. THE REGULATORY 3858 02:43:47,913 --> 02:43:50,115 FRAMEWORK FOR A DE NOVO IS TO 3859 02:43:50,115 --> 02:43:51,517 DETERMINE WHETHER GENERAL 3860 02:43:51,517 --> 02:43:54,219 CONTROLS AND SPECIAL CONTROLS 3861 02:43:54,219 --> 02:43:55,921 ARE ENOUGH TO PROVIDE THAT 3862 02:43:55,921 --> 02:43:59,691 REASONABLE ASSURANCE OF SAFETY 3863 02:43:59,691 --> 02:44:04,897 EFFECT ANDIVENESS. DEVICES 3864 02:44:04,897 --> 02:44:06,331 GRANTED MARKETING AUTHORIZATION 3865 02:44:06,331 --> 02:44:08,534 CAN SERVE AS A PREDICATE DEVICE 3866 02:44:08,534 --> 02:44:10,869 FOR A FUTURE 510K BECAUSE THESE 3867 02:44:10,869 --> 02:44:14,540 ARE CLASS TWO DEVICES. AND A 3868 02:44:14,540 --> 02:44:17,443 UNIQUE PART OF A DE NOVO REVIEW 3869 02:44:17,443 --> 02:44:19,912 IS THE OPPORTUNITY TO GENERATE A 3870 02:44:19,912 --> 02:44:22,214 NEW REGULATION TO HELP DEFINE 3871 02:44:22,214 --> 02:44:25,918 THE DEVICE TYPE AND THE 3872 02:44:25,918 --> 02:44:27,519 NECESSARY TESTING OR SPECIAL 3873 02:44:27,519 --> 02:44:34,993 CONTROLS FOR THAT DEVICE TYPE. 3874 02:44:34,993 --> 02:44:36,128 LAST AMONG THE PREMARKET 3875 02:44:36,128 --> 02:44:38,630 SUBMISSION TYPES, PMAS WHICH ARE 3876 02:44:38,630 --> 02:44:41,266 THE MOST STRINGENT TYPE OF 3877 02:44:41,266 --> 02:44:42,234 MARKETING APPLICATION AND ARE 3878 02:44:42,234 --> 02:44:44,503 THE REGULATORY SUBMISSION THAT 3879 02:44:44,503 --> 02:44:47,940 ALLOWS FDA TO CLASSIFY HIGH RISK 3880 02:44:47,940 --> 02:44:49,775 DEVICES INCLUDING LIFE 3881 02:44:49,775 --> 02:44:51,844 SUSTAINING OR SUPPORTING DEVICES 3882 02:44:51,844 --> 02:44:53,645 THERE ARE NO PREDICATE DEVICES 3883 02:44:53,645 --> 02:44:55,814 SO THE SPONSOR WOULD NEED TO 3884 02:44:55,814 --> 02:44:56,715 DEMONSTRATE INDEPENDENTLY THAT 3885 02:44:56,715 --> 02:44:58,917 THE DEVICE HAS A REASONABLE 3886 02:44:58,917 --> 02:45:01,854 ASSURANCE OF SAFETY AND 3887 02:45:01,854 --> 02:45:02,988 EFFECTIVENESS. SOME DEVICE 3888 02:45:02,988 --> 02:45:05,457 TYPES LISTED IN THE REGULATIONS 3889 02:45:05,457 --> 02:45:08,427 ARE ALREADY CLASSIFIED AS CLASS 3890 02:45:08,427 --> 02:45:11,964 THREE AS OUTLINED IN THE 3891 02:45:11,964 --> 02:45:13,866 REGULATION. AND TYPICALLY THESE 3892 02:45:13,866 --> 02:45:16,468 DO REQUIRE SOME CLINICAL DATA TO 3893 02:45:16,468 --> 02:45:20,072 SUPPORT SAFETY AND 3894 02:45:20,072 --> 02:45:22,174 EFFECTIVENESS. AND ESPECIALLY 3895 02:45:22,174 --> 02:45:28,013 FOR FIRST OF ITS KIND DEVICES 3896 02:45:28,013 --> 02:45:29,715 THERE CAN BE AN ADVISORY PANEL 3897 02:45:29,715 --> 02:45:32,618 WHICH IS A PUBLIC MEETING TO 3898 02:45:32,618 --> 02:45:35,787 HELP PROVIDE ADDITIONAL INPUT ON 3899 02:45:35,787 --> 02:45:37,723 THE SAFETY AND EFFECTIVENESS 3900 02:45:37,723 --> 02:45:40,425 DATA THAT'S BEEN AFFECTED BY THE 3901 02:45:40,425 --> 02:45:42,661 COMPANY. THERE IS ONE MORE 3902 02:45:42,661 --> 02:45:44,630 SUBMISSION TYPE THAT I'D LIKE TO 3903 02:45:44,630 --> 02:45:46,131 SHARE. MANY COMPANIES 3904 02:45:46,131 --> 02:45:47,566 DEVELOPING DEVICES ARE 3905 02:45:47,566 --> 02:45:49,701 INTERESTED IN OBTAINING 3906 02:45:49,701 --> 02:45:51,703 BREAKTHROUGH DESIGNATION WHICH 3907 02:45:51,703 --> 02:45:53,171 IS A PROGRAM THAT WAS INITIATED 3908 02:45:53,171 --> 02:45:58,744 FROM THE 21ST CENTURY ACT. IT'S 3909 02:45:58,744 --> 02:46:00,979 A DESIGNATION THAT PROVIDES 3910 02:46:00,979 --> 02:46:02,214 COMPANIES WITH ADDITIONAL 3911 02:46:02,214 --> 02:46:04,850 RESOURCE TO HELP EXPEDITE THEIR 3912 02:46:04,850 --> 02:46:06,251 DEVELOPMENT AND ALIGN 3913 02:46:06,251 --> 02:46:10,155 EXPECTATIONS WITH FDA THIS SLIDE 3914 02:46:10,155 --> 02:46:11,156 OUTLINES THE TWO CRITERIA THAT 3915 02:46:11,156 --> 02:46:13,258 SHOULD BE MET BY A DEVICE FOR IT 3916 02:46:13,258 --> 02:46:16,662 TO ACHIEVE BREAKTHROUGH 3917 02:46:16,662 --> 02:46:17,796 DESIGNATION. AND YOU CAN SEE IT 3918 02:46:17,796 --> 02:46:19,798 THERE BUT I JUST WOULD LIKE TO 3919 02:46:19,798 --> 02:46:22,734 HIGHLIGHT THE FIRST ONE IS THAT 3920 02:46:22,734 --> 02:46:28,006 IT NEEDS TO PROVIDE A MORE 3921 02:46:28,006 --> 02:46:30,208 EFFECTIVE TREATMENT FOR A 3922 02:46:30,208 --> 02:46:32,377 DISEASE OR CONDITION. AND TO 3923 02:46:32,377 --> 02:46:35,113 TAKE ADVANTAGE OF THIS PROGRAM'S 3924 02:46:35,113 --> 02:46:36,415 RESOURCES A REQUEST FOR 3925 02:46:36,415 --> 02:46:37,950 BREAKTHROUGH SHOULD BE SUBMITTED 3926 02:46:37,950 --> 02:46:41,553 BEFORE YOU SUBMIT YOUR MARKETING 3927 02:46:41,553 --> 02:46:44,656 SUBMISSION AND THIS IS MY LAST 3928 02:46:44,656 --> 02:46:47,593 SLIDE. THERE ARE FDA ACTIVITIES 3929 02:46:47,593 --> 02:46:50,062 AND MANUFACTURER 3930 02:46:50,062 --> 02:46:50,696 RESPONSIBILITIES THAT CONTINUE 3931 02:46:50,696 --> 02:46:53,131 AFTER A DEVICE RECEIVES 3932 02:46:53,131 --> 02:46:54,633 MARKETING AUTHORIZATION. 3933 02:46:54,633 --> 02:46:56,768 SPONSORS DO HAVE REGULATORY 3934 02:46:56,768 --> 02:46:59,171 REQUIREMENTS THAT THEY MUST MEET 3935 02:46:59,171 --> 02:47:01,773 SUCH AS MDR REPORTING FOR ALL 3936 02:47:01,773 --> 02:47:03,976 DEVICES. FDA ALSO HAS THE 3937 02:47:03,976 --> 02:47:05,677 AUTHORITY TO INSPECT 3938 02:47:05,677 --> 02:47:06,345 MANUFACTURER SITES FOR 3939 02:47:06,345 --> 02:47:08,380 COMPLIANCE TO THE REGULATORY 3940 02:47:08,380 --> 02:47:09,448 REQUIREMENTS AND CAN TAKE 3941 02:47:09,448 --> 02:47:11,483 ENFORCEMENT ACTIONS IF COMPANIES 3942 02:47:11,483 --> 02:47:15,153 ARE NOT IN COMPLIANCE. THIS 3943 02:47:15,153 --> 02:47:17,489 CONCLUDES MY OVERVIEW OF THE FDA 3944 02:47:17,489 --> 02:47:19,958 REVIEW PROCESS FOR DEVICES AND I 3945 02:47:19,958 --> 02:47:22,294 LOOK FORWARD TO ANSWERING ANY 3946 02:47:22,294 --> 02:47:27,232 QUESTIONS IN THE Q&A OR LATER IN 3947 02:47:27,232 --> 02:47:28,367 THE DISCUSSION. 3948 02:47:28,367 --> 02:47:29,434 >> THANK YOU SO MUCH DR. AVERY 3949 02:47:29,434 --> 02:47:33,805 WE NEED TO MOVE ONTO THE NEXT 3950 02:47:33,805 --> 02:47:44,082 SPEAKER MISS MARGARET KOEB ER A 3951 02:47:44,082 --> 02:47:45,684 CHIEF MANAGEMENT STAFF IN THE 3952 02:47:45,684 --> 02:47:47,319 OFFICE OF REGULATORY OPERATIONS 3953 02:47:47,319 --> 02:47:49,388 WITHIN THE OFFICE OF NEW 3954 02:47:49,388 --> 02:47:51,490 DRYINGS, CENTER FOR DRUG 3955 02:47:51,490 --> 02:47:54,926 EVALUATION AND RESEARCH. AT 3956 02:47:54,926 --> 02:48:01,133 FDA. THE FLOOR IS YOURS. 3957 02:48:01,133 --> 02:48:05,737 >> THANK YOU, I BELIEVE MY 3958 02:48:05,737 --> 02:48:07,139 SLIDES WOULD BE SHARED FOR ME. 3959 02:48:07,139 --> 02:48:08,540 I'M DELIGHTED TO BE HERE. 3960 02:48:08,540 --> 02:48:11,009 TOWARD THE END OF MY SESSION SO 3961 02:48:11,009 --> 02:48:15,147 I HAVE MY WORK CUT OUT FOR ME IN 3962 02:48:15,147 --> 02:48:17,516 TERMS OF KEEPING ME AWAKE. YOU 3963 02:48:17,516 --> 02:48:19,184 MAY BE WONDERING WHY YOU NEED TO 3964 02:48:19,184 --> 02:48:20,919 HEAR FROM TWO PEOPLE FDA PEOPLE 3965 02:48:20,919 --> 02:48:23,088 AND THE BASIC ANSWER TO THAT IS 3966 02:48:23,088 --> 02:48:26,158 ALTHOUGH WE REGULATE DEVICES AND 3967 02:48:26,158 --> 02:48:31,363 THE WAY REGULATE DRUGS HAVE 3968 02:48:31,363 --> 02:48:32,597 SIMILARITIES AND THERE'S SOME 3969 02:48:32,597 --> 02:48:34,666 DIFFERENCES. WE DO HAVE OUR OWN 3970 02:48:34,666 --> 02:48:36,168 SET OF REGULATIONS AND SO THAT 3971 02:48:36,168 --> 02:48:38,103 IS WHAT I'M HERE TO HELP 3972 02:48:38,103 --> 02:48:39,971 EXPLAIN. THE TITLE OF MY TALK 3973 02:48:39,971 --> 02:48:41,940 IS UNDERSTANDING THE IND 3974 02:48:41,940 --> 02:48:44,242 PROCESS. THERE IS NO WAY THAT 3975 02:48:44,242 --> 02:48:45,343 IF YOU DON'T ALREADY KNOW 3976 02:48:45,343 --> 02:48:47,546 SOMETHING ABOUT INDS, THAT 3977 02:48:47,546 --> 02:48:48,914 YOU'RE GOING TO UNDERSTAND IT IN 3978 02:48:48,914 --> 02:48:49,681 FIFTEEN MINUTES BUT WE'LL DO OUR 3979 02:48:49,681 --> 02:48:53,752 BEST. AND BY WAY OF BACKGROUND, 3980 02:48:53,752 --> 02:48:55,587 I AM WITH THE OFFICE OF 3981 02:48:55,587 --> 02:48:59,157 REGULATORY OPERATIONS, BUT I AM 3982 02:48:59,157 --> 02:49:03,729 ALIGNED WITH THE DIVISION OF 3983 02:49:03,729 --> 02:49:05,530 UROLOGY, OBSTETRICS AND 3984 02:49:05,530 --> 02:49:06,732 GYNECOLOGY SO I AM INVOLVED IN 3985 02:49:06,732 --> 02:49:08,633 THE REVIEW OF APPLICATIONS FOR 3986 02:49:08,633 --> 02:49:12,637 THOSE TYPES OF INDICATIONS. 3987 02:49:12,637 --> 02:49:17,075 NEXT SLIDE, PLEASE. SO WHEN WE 3988 02:49:17,075 --> 02:49:19,711 TALK ABOUT INDS, FIRST OF ALL, 3989 02:49:19,711 --> 02:49:22,147 IT STANDS FOR INVESTIGATIONAL 3990 02:49:22,147 --> 02:49:24,683 ANY DRUG BY YOU'LL OFTEN HEAR IT 3991 02:49:24,683 --> 02:49:28,153 ALSO REFERRED TO AS THE 3992 02:49:28,153 --> 02:49:31,156 APPLICATION TO STUDY THAT NEW 3993 02:49:31,156 --> 02:49:34,259 DRUG. AND WHEN WE SAY NEW DRUG, 3994 02:49:34,259 --> 02:49:37,929 IT'S DEFINITELY A DRUG THAT HAS 3995 02:49:37,929 --> 02:49:39,264 EVER BEEN APPROVED WOULD REQUIRE 3996 02:49:39,264 --> 02:49:41,166 AN IND BUT THERE'S ALSO A 3997 02:49:41,166 --> 02:49:42,434 REQUIREMENT THAT COMES INTO 3998 02:49:42,434 --> 02:49:44,903 EFFECT IF YOU'RE USING AN 3999 02:49:44,903 --> 02:49:50,142 APPROVED DRUG FOR A NEW USE IF 4000 02:49:50,142 --> 02:49:51,977 THAT USE WOULD INTRODUCE NEW 4001 02:49:51,977 --> 02:49:54,813 RISKS OR MAKE THE EXISTING KNOWN 4002 02:49:54,813 --> 02:49:56,114 RISKS LESS ACCEPTABLE. SO 4003 02:49:56,114 --> 02:49:58,650 THAT'S WHAT WE'RE TALKING ABOUT 4004 02:49:58,650 --> 02:50:01,286 HERE. ANYTIME YOU WANT TO DO A 4005 02:50:01,286 --> 02:50:04,422 STUDY TO INCLUDE THESE TYPES OF 4006 02:50:04,422 --> 02:50:07,959 PRODUCTS, YOU WOULD SEND IN THIS 4007 02:50:07,959 --> 02:50:08,794 APPLICATION. AND WHAT DOES THAT 4008 02:50:08,794 --> 02:50:10,729 LOOK LIKE? WELL, THERE ARE 4009 02:50:10,729 --> 02:50:15,767 REGULATIONS OUTLINED IN 21 CFR 4010 02:50:15,767 --> 02:50:18,570 312.23 FROM THE REGULATORY 4011 02:50:18,570 --> 02:50:20,772 ASPECT FOR THE SUBMISSION TO BE 4012 02:50:20,772 --> 02:50:23,175 COMPLETE IT MUST INCLUDE AT 4013 02:50:23,175 --> 02:50:33,718 LEAST THE COVER LETTER, THE FORM 4014 02:50:40,559 --> 02:50:43,528 1571 THAT ALLOWS US TO REVIEW 4015 02:50:43,528 --> 02:50:44,996 WHAT YOU SENT IN AND IN THAT 4016 02:50:44,996 --> 02:50:47,833 FORM YOU SIGN YOU INTEND TO 4017 02:50:47,833 --> 02:50:51,970 FOLLOW ALL THE REGULATIONS. THE 4018 02:50:51,970 --> 02:50:56,875 FORM 3674 WHETHER OR NOT YOU'RE 4019 02:50:56,875 --> 02:50:58,043 COMPLYING WITH THE REGULATION OF 4020 02:50:58,043 --> 02:50:59,611 THE TRIALS. YOU SHOULD INCLUDE 4021 02:50:59,611 --> 02:51:02,480 A TABLE OF CONTENTS, AN 4022 02:51:02,480 --> 02:51:03,548 INTRODUCTORY STATEMENT AND 4023 02:51:03,548 --> 02:51:04,749 GENERAL INVESTIGATIONAL PLAN. 4024 02:51:04,749 --> 02:51:07,185 TELL US WHAT YOU HAVE IN MIND 4025 02:51:07,185 --> 02:51:09,187 AND THEN IN THERE ARE MULTIPLE 4026 02:51:09,187 --> 02:51:11,256 INVESTIGATORS, YOU'LL WANT TO 4027 02:51:11,256 --> 02:51:14,025 INCLUDE THE INVESTIGATOR'S 4028 02:51:14,025 --> 02:51:23,068 BROCHURE. NEXT SLIDE, PLEASE. 4029 02:51:23,068 --> 02:51:25,537 OTHER TECHNICAL SECTIONS ARE THE 4030 02:51:25,537 --> 02:51:28,106 NON-CLINICAL. THINGS LIKE BASIC 4031 02:51:28,106 --> 02:51:31,776 EXPOSURE DATA. YOU DON'T WANT 4032 02:51:31,776 --> 02:51:34,112 TO GO FIRST IN HUMAN WHEN YOU 4033 02:51:34,112 --> 02:51:39,851 HAVE NOTHING TO SUPPORT THAT 4034 02:51:39,851 --> 02:51:42,254 USE. IN TERMS OF SAFETY THERE'S 4035 02:51:42,254 --> 02:51:43,722 ALSO A SECTION ON CHEMISTRY, 4036 02:51:43,722 --> 02:51:45,357 MANUFACTURING AND CONTROLS. 4037 02:51:45,357 --> 02:51:46,157 THIS MEANS YOU HAVE TO SUPPLY 4038 02:51:46,157 --> 02:51:47,759 SUFFICIENT INFORMATION TO ASSURE 4039 02:51:47,759 --> 02:51:50,262 THAT YOU CAN PROPERLY IDENTIFY 4040 02:51:50,262 --> 02:51:53,064 THE QUALITY, THE PURITY AND THE 4041 02:51:53,064 --> 02:51:55,834 STRENGTH, AND THAT THIS PRODUCT 4042 02:51:55,834 --> 02:51:58,436 CAN BE MANUFACTURERED IN AN 4043 02:51:58,436 --> 02:52:02,073 ADEQUATE FACILITY AND CONSISTENT 4044 02:52:02,073 --> 02:52:03,975 FROM ONE BATCH TO ANOTHER 4045 02:52:03,975 --> 02:52:06,878 INSOFAR AS POSSIBLE. NEXT 4046 02:52:06,878 --> 02:52:08,179 SLIDE. WHAT MOST OF YOU ARE 4047 02:52:08,179 --> 02:52:10,815 PROBABLY INTERESTED IN TODAY, 4048 02:52:10,815 --> 02:52:12,217 THAT CLINICAL PROTOCOL, FIRST 4049 02:52:12,217 --> 02:52:14,552 YOU HAVE TO DETERMINE THE PHASE 4050 02:52:14,552 --> 02:52:16,521 OF DEVELOPMENT AND THIS BECOMES 4051 02:52:16,521 --> 02:52:17,188 IMPORTANT BECAUSE THE STANDARDS 4052 02:52:17,188 --> 02:52:20,392 FOR ALLOWING A STUDY TO PROCEED 4053 02:52:20,392 --> 02:52:23,762 WILL BE DETERMINED BY WHAT PHASE 4054 02:52:23,762 --> 02:52:26,131 YOU'RE IN. YOU MUST ALSO 4055 02:52:26,131 --> 02:52:29,768 PROVIDE ANY SUPPORTING DATA. IN 4056 02:52:29,768 --> 02:52:31,670 OTHER WORDS, IF YOU ARE AWARE OF 4057 02:52:31,670 --> 02:52:32,871 TRIALS DONE OUTSIDE THE U.S. 4058 02:52:32,871 --> 02:52:34,773 YOU'D WANT TO CERTAINLY INCLUDE 4059 02:52:34,773 --> 02:52:36,408 INFORMATION ABOUT THOSE TRIALS 4060 02:52:36,408 --> 02:52:38,710 AND THEN PHARMACOKINETIC DATA IF 4061 02:52:38,710 --> 02:52:41,446 THERE IS ANY, THAT'S ALREADY 4062 02:52:41,446 --> 02:52:45,817 BEEN GATHERED, AND YOU WANT TO 4063 02:52:45,817 --> 02:52:46,952 ESPECIALLY BE SURE TO ADDRESS 4064 02:52:46,952 --> 02:52:48,987 HOW YOU ARE GOING TO ENSURE THE 4065 02:52:48,987 --> 02:52:50,689 SAFETY OF PATIENTS AND SUBJECTS 4066 02:52:50,689 --> 02:52:53,525 IN THE STUDY. THIS IS THE 4067 02:52:53,525 --> 02:52:55,927 NUMBER ONE REASON WHY WE TELL 4068 02:52:55,927 --> 02:52:59,197 FOLKS THEIR STUDY MAY NOT 4069 02:52:59,197 --> 02:53:01,199 PROCEED. SO BE VERY COGNIZANT 4070 02:53:01,199 --> 02:53:08,406 OF THAT, PLEASE. NEXT SLIDE. 4071 02:53:08,406 --> 02:53:10,642 AND THE FORMAT, YOU CAN SEND IT 4072 02:53:10,642 --> 02:53:13,244 IN IF IT IS A RESEARCH IND 4073 02:53:13,244 --> 02:53:15,981 MEANING IT'S BEING CONDUCTED NOT 4074 02:53:15,981 --> 02:53:17,749 FOR COMMERCIAL PURPOSES. IT CAN 4075 02:53:17,749 --> 02:53:20,418 BE SUBMITTED IN PAPER. THERE IS 4076 02:53:20,418 --> 02:53:22,087 ALSO A MECHANISM TO SEND IT 4077 02:53:22,087 --> 02:53:25,023 THROUGH AN ELECTRONIC PORTAL. 4078 02:53:25,023 --> 02:53:26,358 WHAT YOU CANNOT DO AND I CAN'T 4079 02:53:26,358 --> 02:53:28,026 TELL YOU THE NUMBER OF TIMES 4080 02:53:28,026 --> 02:53:29,694 PEOPLE TRY TO DO THIS, YOU CAN'T 4081 02:53:29,694 --> 02:53:31,529 E-MAIL IT TO US. THAT'S JUST 4082 02:53:31,529 --> 02:53:35,967 NOT GOING TO WORK. SO IF IT IS, 4083 02:53:35,967 --> 02:53:38,069 HOWEVER, A COMMERCIAL IND THEN 4084 02:53:38,069 --> 02:53:40,705 IT MUST BE SUBMITTED 4085 02:53:40,705 --> 02:53:41,606 ELECTRONICALLY THROUGH THE 4086 02:53:41,606 --> 02:53:44,576 ELECTRONIC SUBMISSIONS GATE WEI 4087 02:53:44,576 --> 02:53:45,610 AND IT MUST BE IN COMMON 4088 02:53:45,610 --> 02:53:48,213 TECHNICAL DOCUMENT FORMAT. AND 4089 02:53:48,213 --> 02:53:50,248 THERE ARE LOTS OF RESOURCES TO 4090 02:53:50,248 --> 02:53:53,318 HELP YOU DETERMINE HOW TO DO 4091 02:53:53,318 --> 02:54:00,725 THAT. NEXT SLIDE SH, SO ONCE Y 4092 02:54:00,725 --> 02:54:03,895 SUBMITTED YOUR APPLICATION WHAT 4093 02:54:03,895 --> 02:54:05,296 HAPPENS NEXT? WE ASSEMBLE A 4094 02:54:05,296 --> 02:54:07,966 REVIEW TEAM THAT INCLUDES 4095 02:54:07,966 --> 02:54:09,968 EXPERTS IN REGULATORY, CLINICAL, 4096 02:54:09,968 --> 02:54:12,871 NON-CLINICAL PHARMACOLOGY AND 4097 02:54:12,871 --> 02:54:15,473 TOXICOLOGY, CHEMISTRY, CLINICAL 4098 02:54:15,473 --> 02:54:18,710 PHARMACOLOGY, BIO STATISTICS, 4099 02:54:18,710 --> 02:54:20,412 EVEN IF IT'S THE FIRST THING 4100 02:54:20,412 --> 02:54:22,313 WE'VE SEEN FROM YOU IF IT'S A 4101 02:54:22,313 --> 02:54:24,182 PHASE THREE PROTOCOL THE 4102 02:54:24,182 --> 02:54:25,750 STATISTICIANS WILL DEFINITELY 4103 02:54:25,750 --> 02:54:26,484 WANT TO BE INVOLVED AND THEN WE 4104 02:54:26,484 --> 02:54:28,486 ALSO BRING IN OTHER EXPERTS 4105 02:54:28,486 --> 02:54:31,956 DEPENDING ON THE TYPE OF 4106 02:54:31,956 --> 02:54:35,860 PRODUCT. IF IT IS A COMBINATION 4107 02:54:35,860 --> 02:54:36,728 PRODUCT THAT INCLUDES A DRUG AND 4108 02:54:36,728 --> 02:54:39,297 A DEVICE AND A PRIMARY MODE OF 4109 02:54:39,297 --> 02:54:43,334 ACTION IS CHEMICAL RATHER THAN 4110 02:54:43,334 --> 02:54:46,337 MECHANICAL, THAT WOULD BE STILL 4111 02:54:46,337 --> 02:54:51,609 REVIEWED PRIMARILY BY S CDR BUT 4112 02:54:51,609 --> 02:54:58,550 WE WILL CONSULT OTHERS AS WELL. 4113 02:54:58,550 --> 02:55:00,151 BOTANICAL RAISE INTERESTING 4114 02:55:00,151 --> 02:55:00,385 ISSUES. 4115 02:55:00,385 --> 02:55:02,787 WE HAVE A WHOLE TEAM DEVOTED TO 4116 02:55:02,787 --> 02:55:04,155 REVIEWING ANYTHING POE DANNAL. 4117 02:55:04,155 --> 02:55:07,926 IF YOUR STUDY INVOLVES CHILDREN 4118 02:55:07,926 --> 02:55:11,062 WE WILL FREQUENTLY BRING IN OUR 4119 02:55:11,062 --> 02:55:12,997 PEDIATRIC EXPERTS AND WE ALSO 4120 02:55:12,997 --> 02:55:15,133 HAVE A STAFF OF ETHICISTS WHO 4121 02:55:15,133 --> 02:55:16,768 CAN HELP US OUT IN SITUATIONS 4122 02:55:16,768 --> 02:55:17,635 WHERE THAT MIGHT BE IMPORTANT 4123 02:55:17,635 --> 02:55:21,339 FOR THEM TO WEIGH IN. THE NEXT 4124 02:55:21,339 --> 02:55:23,575 SLIDE, PLEASE. SO THE FIRST 30 4125 02:55:23,575 --> 02:55:26,344 DAYS IS ALL ABOUT A SAFETY 4126 02:55:26,344 --> 02:55:28,012 REVIEW. WE HAVE 30 DAYS FROM 4127 02:55:28,012 --> 02:55:30,215 THE DAY WE RECEIVE YOUR 4128 02:55:30,215 --> 02:55:31,883 APPLICATION TO DETERMINE WHETHER 4129 02:55:31,883 --> 02:55:34,519 THE STUDY IS REASONABLY SAFE TO 4130 02:55:34,519 --> 02:55:37,222 PROCEED OR IF IT'S NOT, WE WILL 4131 02:55:37,222 --> 02:55:40,125 PUT IT ON WHAT'S KNOWN AS 4132 02:55:40,125 --> 02:55:41,693 CLINICAL HOLD MEANING YOU WILL 4133 02:55:41,693 --> 02:55:43,228 NOT BE ABLE TO LEGALLY CONDUCT 4134 02:55:43,228 --> 02:55:46,931 THAT STUDY IN THE UNITED STATES. 4135 02:55:46,931 --> 02:55:48,700 SOME DIVISIONS MAY ISSUE WHAT'S 4136 02:55:48,700 --> 02:55:50,969 KNOWN AS A SAFE TO PROCEED 4137 02:55:50,969 --> 02:55:52,537 LETTER BUT EVEN WITHOUT THAT 4138 02:55:52,537 --> 02:55:54,973 LETTER, IF YOU DO NOT HEAR THAT 4139 02:55:54,973 --> 02:55:57,142 YOU'RE ON CLINICAL HOLD WITHIN 4140 02:55:57,142 --> 02:55:59,544 THIRTY DAYS YOU CAN LEGALLY 4141 02:55:59,544 --> 02:56:02,814 START CONDUCT OF THE STUDY. ONE 4142 02:56:02,814 --> 02:56:05,116 THING I WOULD LIKE TO STRESS, WE 4143 02:56:05,116 --> 02:56:08,052 DON'T APPROVE INDS. WE ALLOW 4144 02:56:08,052 --> 02:56:11,956 THEM TO PROCEED. BUT THAT'S NOT 4145 02:56:11,956 --> 02:56:13,324 THE SAME STANDARD AS DETERMINING 4146 02:56:13,324 --> 02:56:17,262 AN APPROVAL. THAT COMES MUCH 4147 02:56:17,262 --> 02:56:20,198 LATER ON IN THE NEW DRUG 4148 02:56:20,198 --> 02:56:22,433 APPLICATION PHASE. COMPLEX 4149 02:56:22,433 --> 02:56:24,669 PRODUCTS DON'T GIVE US EXTRA 4150 02:56:24,669 --> 02:56:26,804 TIME. IN OTHER WORDS, WE HAVE 4151 02:56:26,804 --> 02:56:28,740 30 DAYS, WE ONLY HAVE 30 DAYS, 4152 02:56:28,740 --> 02:56:32,510 YOU DON'T HEAR FROM US, YOU CAN 4153 02:56:32,510 --> 02:56:33,811 PROCEED. NOW, THERE ARE 4154 02:56:33,811 --> 02:56:35,513 OCCASIONS WHERE WE WILL REACH 4155 02:56:35,513 --> 02:56:37,982 OUT TO A SPONSOR AND SAY, YOU 4156 02:56:37,982 --> 02:56:39,817 KNOW, WE'RE GOING TO NEED SOME 4157 02:56:39,817 --> 02:56:41,920 MORE TIME. WE WOULD VERY MUCH 4158 02:56:41,920 --> 02:56:43,521 APPRECIATE IT IF YOU WOULD AGREE 4159 02:56:43,521 --> 02:56:45,390 NOT TO START THE STUDY UNTIL YOU 4160 02:56:45,390 --> 02:56:47,358 HEAR FROM US. I WILL SAY THAT 4161 02:56:47,358 --> 02:56:50,995 EVEN IF YOUR STUDY IS NOT ON 4162 02:56:50,995 --> 02:56:54,232 CLINICAL HOLD WE WILL VERY OFTEN 4163 02:56:54,232 --> 02:56:57,502 HAVE SOME ADVICE TO GIVE IN 4164 02:56:57,502 --> 02:56:59,470 TERMS OF WAYS THAT WE THINK YOU 4165 02:56:59,470 --> 02:57:03,975 MAY IMPROVE THE STUDY TO REACH 4166 02:57:03,975 --> 02:57:07,979 YOUR OBJECTIVES MORE 4167 02:57:07,979 --> 02:57:10,248 EFFICIENTLY. NEXT SLIDE, 4168 02:57:10,248 --> 02:57:14,652 PLEASE. ONCE YOU PASS 30 DAYS, 4169 02:57:14,652 --> 02:57:18,890 AND YOUR STUDY IS UNDERWAY YOU 4170 02:57:18,890 --> 02:57:19,958 CAN AMEND THAT APPLICATION WHEN 4171 02:57:19,958 --> 02:57:23,127 THINGS CHANGE. THE TYPES OF 4172 02:57:23,127 --> 02:57:25,496 AMENDMENTS INCLUDE BOTH PROTOCOL 4173 02:57:25,496 --> 02:57:26,064 AMENDMENTS AND INFORMATION 4174 02:57:26,064 --> 02:57:27,332 AMENDMENTS AND WE'LL TALK A 4175 02:57:27,332 --> 02:57:28,833 LITTLE BIT MORE ABOUT THE TYPES 4176 02:57:28,833 --> 02:57:31,970 OF THINGS THAT THAT MIGHT 4177 02:57:31,970 --> 02:57:34,606 ENTAIL. NEXT SLIDE. SO A 4178 02:57:34,606 --> 02:57:36,207 PROTOCOL AMENDMENT INCLUDES 4179 02:57:36,207 --> 02:57:39,310 THINGS LIKE A NEW PROTOCOL. IF 4180 02:57:39,310 --> 02:57:41,312 THERE IS A CHANGE IN YOUR 4181 02:57:41,312 --> 02:57:42,547 EXISTING PROTOCOL THAT WOULD BE 4182 02:57:42,547 --> 02:57:44,515 A PROTOCOL AMENDMENT AND ANYTIME 4183 02:57:44,515 --> 02:57:47,885 YOU ADD A NEW INVESTIGATOR TO A 4184 02:57:47,885 --> 02:57:49,954 PROTOCOL, YOU WANT TO SEND AN 4185 02:57:49,954 --> 02:57:51,356 AMENDMENT TO SHARE THAT 4186 02:57:51,356 --> 02:57:55,159 INFORMATION WITH US. NEXT 4187 02:57:55,159 --> 02:57:56,894 SLIDE. INFORMATION AMENDMENTS. 4188 02:57:56,894 --> 02:57:58,930 IF IT'S NOT A PROTOCOL AMENDMENT 4189 02:57:58,930 --> 02:58:03,735 BY BUT STILL SOMETHING YOU WANT 4190 02:58:03,735 --> 02:58:05,570 TO TELL US YOU CAN SEND AN 4191 02:58:05,570 --> 02:58:06,070 INFORMATION AMENDMENT. 4192 02:58:06,070 --> 02:58:07,705 THIS CAN INCLUDE NEW INFORMATION 4193 02:58:07,705 --> 02:58:11,709 MAYBE EVEN FROM FOREIGN STUDIES. 4194 02:58:11,709 --> 02:58:14,112 CLINICAL. CLINICAL 4195 02:58:14,112 --> 02:58:15,747 PHARMACOLOGY. SOME NON-CLINICAL 4196 02:58:15,747 --> 02:58:16,681 INFORMATION. NEW CHEMISTRY 4197 02:58:16,681 --> 02:58:19,951 INFORMATION. AND STUDY REPORTS. 4198 02:58:19,951 --> 02:58:22,220 YOU ARE ALSO OBLIGATED TO LET US 4199 02:58:22,220 --> 02:58:29,294 KNOW IF YOU DISCOUNT -- 4200 02:58:29,294 --> 02:58:33,031 DISCONTINUE A STUDY WITHIN FIVE 4201 02:58:33,031 --> 02:58:33,865 DAYS OF DOING SO. 4202 02:58:33,865 --> 02:58:35,667 OTHER AMENDMENTS INCLUDE IF 4203 02:58:35,667 --> 02:58:37,802 YOU'RE THE SPONSOR AND YOU WANT 4204 02:58:37,802 --> 02:58:40,838 TO TRANSFER THAT IND TO ANOTHER 4205 02:58:40,838 --> 02:58:42,307 ENTITY, YOU HAVE TO TELL US 4206 02:58:42,307 --> 02:58:46,477 ABOUT THAT. AND THAT NEW ENTITY 4207 02:58:46,477 --> 02:58:49,681 ALSO HAS TO ACCEPT THAT 4208 02:58:49,681 --> 02:58:53,017 ASSIGNMENT OR TRANSFER AND THEN 4209 02:58:53,017 --> 02:58:54,719 FINALLY IF YOU MOVE YOU GOT TO 4210 02:58:54,719 --> 02:58:55,887 LET US KNOW AND YOU'LL HAVE TO 4211 02:58:55,887 --> 02:58:57,121 SEND IN A CHANGE OF ADDRESS FOR 4212 02:58:57,121 --> 02:59:00,858 THAT. NEXT SLIDE, PLEASE. AND 4213 02:59:00,858 --> 02:59:02,827 FINALLY THERE ARE SOME IND 4214 02:59:02,827 --> 02:59:04,329 REPORTING REQUIREMENTS. SAFETY 4215 02:59:04,329 --> 02:59:10,201 REPORTS AND ANNUAL REPORTS. 4216 02:59:10,201 --> 02:59:14,539 NEXT SLIDE. AND IN TERMS OF 4217 02:59:14,539 --> 02:59:17,775 OTHER ACTIVITIES, IF YOU ARE NOT 4218 02:59:17,775 --> 02:59:20,445 CONDUCTING STUDIES CURRENTLY OR 4219 02:59:20,445 --> 02:59:22,113 PERHAPS YOU NEVER STARTED THE 4220 02:59:22,113 --> 02:59:24,749 STUDY THAT YOU HAD SENT THE 4221 02:59:24,749 --> 02:59:28,019 PROTOCOL FOR, YOU CAN CHOOSE TO 4222 02:59:28,019 --> 02:59:29,787 HAVE THAT IND INACTIVATED AND 4223 02:59:29,787 --> 02:59:31,522 THE BENEFIT OF THAT IS THEN YOU 4224 02:59:31,522 --> 02:59:33,725 WOULD NOT BE REQUIRED TO SUBMIT 4225 02:59:33,725 --> 02:59:36,260 AN ANNUAL REPORT. IF YOU WERE 4226 02:59:36,260 --> 02:59:39,630 TO RESUME ACTIVITIES UNDER THAT 4227 02:59:39,630 --> 02:59:41,466 IND YOU WOULD SEND IN A REQUEST 4228 02:59:41,466 --> 02:59:43,568 FOR REACTIVATION. ONCE YOU DO 4229 02:59:43,568 --> 02:59:46,637 THAT, THE 30 DAY CLOCK STARTS 4230 02:59:46,637 --> 02:59:48,206 AGAIN. SO YOU CAN'T START 4231 02:59:48,206 --> 02:59:49,207 ANYTHING UNTIL YOU HEAR -- UNTIL 4232 02:59:49,207 --> 02:59:53,711 30 DAYS ARE PASSED. IF YOU ARE 4233 02:59:53,711 --> 02:59:57,081 DONE WITH YOUR STUDIES UNDER THE 4234 02:59:57,081 --> 02:59:58,516 IND AND YOU HAVE NO INTENTION OF 4235 02:59:58,516 --> 02:59:59,617 DOING ANYMORE, YOU CAN REQUEST 4236 02:59:59,617 --> 03:00:05,123 THAT THE IND BE WITHDRAWN. AND 4237 03:00:05,123 --> 03:00:09,494 FINALLY, IF WE DETERMINE THAT 4238 03:00:09,494 --> 03:00:10,762 YOU ARE NOT COMPLIANT WITH THE 4239 03:00:10,762 --> 03:00:14,298 IND REGULATIONS WE CAN TERMINATE 4240 03:00:14,298 --> 03:00:15,933 YOUR IND MEANING YOU WOULD NOT 4241 03:00:15,933 --> 03:00:18,636 BE ALLOWED TO CONTINUE ANY 4242 03:00:18,636 --> 03:00:24,275 PROTOCOLS UNDER THAT IND. NEXT 4243 03:00:24,275 --> 03:00:28,646 SLIDE. SO THERE'S A LOT OF 4244 03:00:28,646 --> 03:00:30,248 INFORMATION THAT WE PUT OUT 4245 03:00:30,248 --> 03:00:32,650 ABOUT PROCESSES AND I HAVE TRIED 4246 03:00:32,650 --> 03:00:35,353 TO JUST CAPTURE SOME OF THE MOST 4247 03:00:35,353 --> 03:00:36,020 HELPFUL. AND SO THERE ARE SOME 4248 03:00:36,020 --> 03:00:41,592 LINKS EMBEDDED HERE. NEXT 4249 03:00:41,592 --> 03:00:43,561 SLIDE. SOME OTHER RESOURCES 4250 03:00:43,561 --> 03:00:46,697 THAT YOU MIGHT FIND HELPFUL IF 4251 03:00:46,697 --> 03:00:50,101 YOU WANT TO LEARN MORE ABOUT 4252 03:00:50,101 --> 03:00:51,102 ELECTRONIC SUBMISSIONS YOU CAN 4253 03:00:51,102 --> 03:00:54,639 SEND AN E-MAIL TO THAT ADDRESS 4254 03:00:54,639 --> 03:01:02,747 THERE. AND THEN YOU ALSO IF YOU 4255 03:01:02,747 --> 03:01:04,982 WANT TO CORRESPOND BY E-MAIL 4256 03:01:04,982 --> 03:01:08,152 WITH THE FDA YOU WILL NEED TO 4257 03:01:08,152 --> 03:01:09,954 SET UP SECURE E-MAIL TO DO THAT. 4258 03:01:09,954 --> 03:01:12,023 ANYTHING THAT REQUIRES A 4259 03:01:12,023 --> 03:01:16,127 REGULATORY OPINION, ADVICE OR 4260 03:01:16,127 --> 03:01:17,328 CERTAINLY ANY KIND OF ACTION ON 4261 03:01:17,328 --> 03:01:19,163 OUR PART THAT IS NOT ACCEPTABLE 4262 03:01:19,163 --> 03:01:22,500 FOR E-MAIL. SO THIS WOULD BE 4263 03:01:22,500 --> 03:01:24,769 FOR THINGS LIKE IF WE ARE -- IF 4264 03:01:24,769 --> 03:01:26,838 WE GRANTED YOU A MEETING AND NOW 4265 03:01:26,838 --> 03:01:28,573 WE'RE GOING TO TALK ABOUT WHEN 4266 03:01:28,573 --> 03:01:30,808 THAT MEETING COULD BE. SOME 4267 03:01:30,808 --> 03:01:34,545 LOGISTICAL TYPES OF THINGS LIKE 4268 03:01:34,545 --> 03:01:35,580 THAT BUT ANYTHING THAT REQUIRES 4269 03:01:35,580 --> 03:01:39,717 US TO MAKE A DECISION SHOULD BE 4270 03:01:39,717 --> 03:01:43,120 FORMALLY SUBMITTED. AND NEXT 4271 03:01:43,120 --> 03:01:46,190 SLIDE, SO ALL OF THAT 4272 03:01:46,190 --> 03:01:50,661 INFORMATION VERY QUICK, IF YOU 4273 03:01:50,661 --> 03:01:52,997 HAVE SPECIFIC QUESTIONS OR 4274 03:01:52,997 --> 03:01:54,832 ANYTHING WAS NOT CLEAR, I HAVE 4275 03:01:54,832 --> 03:01:55,833 INCLUDE MY DIRECT WORK PHONE 4276 03:01:55,833 --> 03:01:57,768 NUMBER AND MY E-MAIL ADDRESS. 4277 03:01:57,768 --> 03:01:59,437 DON'T E-MAIL ME IF YOU DON'T 4278 03:01:59,437 --> 03:02:01,506 HAVE SECURE E-MAIL THOUGH. AND 4279 03:02:01,506 --> 03:02:04,742 I AM HAPPY TO HELP IF IT'S A 4280 03:02:04,742 --> 03:02:06,177 QUESTION I CAN'T ANSWER MYSELF I 4281 03:02:06,177 --> 03:02:07,979 WILL CERTAINLY PUT YOU IN 4282 03:02:07,979 --> 03:02:11,616 CONSTITUENT WITH THE -- TOUCH 4283 03:02:11,616 --> 03:02:12,450 WITH THE PEOPLE WHO CAN. 4284 03:02:12,450 --> 03:02:13,784 I REALLY APPRECIATE YOUR 4285 03:02:13,784 --> 03:02:16,687 ATTENTION. AND LOOK FORWARD TO 4286 03:02:16,687 --> 03:02:20,458 ANY QUESTIONS OR COMMENTS YOU 4287 03:02:20,458 --> 03:02:23,427 MAY HAVE. THANK YOU. 4288 03:02:23,427 --> 03:02:25,830 >> THANK YOU SO MUCH. AND WE 4289 03:02:25,830 --> 03:02:35,840 HAVE OUR LAST SPEAKER. DR. ERIC 4290 03:02:35,840 --> 03:02:46,350 HOW DABUD 4291 03:02:46,984 --> 03:02:48,719 HUDAK. DR. HIGH DABBING, THE 4292 03:02:48,719 --> 03:02:51,489 FLOOR IS YOURS. 4293 03:02:51,489 --> 03:02:52,456 >> THANK YOU, HELENA AND GOOD 4294 03:02:52,456 --> 03:02:55,526 AFTERNOON, EVERYONE. TODAY I 4295 03:02:55,526 --> 03:02:57,094 WILL BE TAKING YOU THROUGH THE 4296 03:02:57,094 --> 03:02:59,997 GRANT PROGRAMS AND RESOURCES WE 4297 03:02:59,997 --> 03:03:02,300 HAVE AVAILABLE THROUGH THE 4298 03:03:02,300 --> 03:03:03,901 INITIATIVE, THE SUPPORT RESEARCH 4299 03:03:03,901 --> 03:03:06,571 FUND. SO THE NIH HEAL 4300 03:03:06,571 --> 03:03:08,806 INITIATIVE TOR HELPING TO END 4301 03:03:08,806 --> 03:03:10,207 ADDICTION LONG-TERM INITIATIVE 4302 03:03:10,207 --> 03:03:13,511 IS AN NIH-WIDE EFFORT TO SPEED 4303 03:03:13,511 --> 03:03:14,779 SCIENTIFIC SOLUTION TO STEM THE 4304 03:03:14,779 --> 03:03:16,714 NATIONAL OPIOID PUBLIC HEALTH 4305 03:03:16,714 --> 03:03:18,249 CRISIS. TO DO THIS WE'VE 4306 03:03:18,249 --> 03:03:19,150 LAUNCHED A COORDINATED SET OF 4307 03:03:19,150 --> 03:03:21,752 PROGRAM TO BETTER UNDERSTAND, 4308 03:03:21,752 --> 03:03:24,655 MANAGE AND TREAT PAIN AND TO 4309 03:03:24,655 --> 03:03:27,091 IMPROVE PREVENTION AND TREATMENT 4310 03:03:27,091 --> 03:03:29,927 STRATEGIES FOR OPIOID MISUSE AND 4311 03:03:29,927 --> 03:03:32,930 DISORDER. HEAL IS CO-LED BY THE 4312 03:03:32,930 --> 03:03:36,667 DIRECTORS BY THE DIRECTORS ON 4313 03:03:36,667 --> 03:03:41,172 THE INSTITUTE OF DRUG ABUSE, 4314 03:03:41,172 --> 03:03:47,878 DR. NORA AND DR. TALT WALT 4315 03:03:47,878 --> 03:03:51,015 EVERY. WE HAVE INITIATIVES IN 4316 03:03:51,015 --> 03:03:52,850 ALL 50 STATES. 4317 03:03:52,850 --> 03:03:55,353 HEAL IS A COLLABORATION ACROSS 4318 03:03:55,353 --> 03:03:57,121 INSTITUTES AND CENTERS AND 4319 03:03:57,121 --> 03:03:57,855 THROUGH OUR RESEARCH WE HAVE 4320 03:03:57,855 --> 03:04:02,193 GAINED OVER 40 FDA APPROVALS FOR 4321 03:04:02,193 --> 03:04:03,828 INVESTIGATIONAL NEW DRUGS OR 4322 03:04:03,828 --> 03:04:06,130 DEVICES AND CURRENTLY OVER 300 4323 03:04:06,130 --> 03:04:09,800 CLINICAL TRIALS ARE UNDERWEI WE 4324 03:04:09,800 --> 03:04:10,835 ALSO HAVE ONGOING PARTNERSHIPS 4325 03:04:10,835 --> 03:04:12,136 WITH COMMUNITIES, FEDERAL, STATE 4326 03:04:12,136 --> 03:04:15,539 AND LOCAL AGENCIES, AND PRIVATE 4327 03:04:15,539 --> 03:04:26,083 SECTOR, COMPANIES AND ACADEMIA. 4328 03:04:27,151 --> 03:04:29,720 WE WANT TO PROVIDE SAFE PAIN 4329 03:04:29,720 --> 03:04:31,956 TREATMENT TO IMPROVE QUALITY OF 4330 03:04:31,956 --> 03:04:33,791 LIFE FOR ALL PEOPLE. THROUGH 4331 03:04:33,791 --> 03:04:35,693 THESE RESEARCH EFFORTS WE WANT 4332 03:04:35,693 --> 03:04:38,929 TO UNDERSTAND THE BIOLOGICAL 4333 03:04:38,929 --> 03:04:41,332 UNDERPINNINGS OF CHRONIC PAIN, 4334 03:04:41,332 --> 03:04:44,001 UNDERSTAND THE DISCOVERY OF PAIN 4335 03:04:44,001 --> 03:04:45,736 TREATMENTS. ADVANCE NEW 4336 03:04:45,736 --> 03:04:47,972 NONADDICTIVE PAIN TREATMENTS 4337 03:04:47,972 --> 03:04:50,174 THROUGH THE CLINICAL PIPELINE, 4338 03:04:50,174 --> 03:04:52,343 INFORM BEST PRACTICES FOR 4339 03:04:52,343 --> 03:04:53,444 EFFECTIVE PAIN MANAGEMENT WHILE 4340 03:04:53,444 --> 03:04:55,312 MINIMIZING THE RISK OF 4341 03:04:55,312 --> 03:04:56,781 ADDICTION. SINCE 2018 WHEN HEAL 4342 03:04:56,781 --> 03:04:59,116 WAS LAUNCHED WE HAVE INVESTED 4343 03:04:59,116 --> 03:05:01,819 OVER 1.25 BILLION DOLLARS ON 4344 03:05:01,819 --> 03:05:07,792 PAIN AND CROSSCUTTING RESEARCH. 4345 03:05:07,792 --> 03:05:09,226 THIS SLIDESHOWS A SNAPSHOT OF 4346 03:05:09,226 --> 03:05:10,861 ALL THE DIFFERENT HEAL PROGRAMS 4347 03:05:10,861 --> 03:05:12,430 WITH FUNDING TO SUPPORT PAIN 4348 03:05:12,430 --> 03:05:13,931 RESEARCH. AS YOU CAN SEE OUR 4349 03:05:13,931 --> 03:05:15,966 PROGRAMS COVER THE ENTIRE 4350 03:05:15,966 --> 03:05:17,735 PIPELINE FROM DISCOVERY RESEARCH 4351 03:05:17,735 --> 03:05:19,437 THROUGH CLINICAL TRIALS AND 4352 03:05:19,437 --> 03:05:20,905 IMPLEMENTATION SCIENCE. WE 4353 03:05:20,905 --> 03:05:23,107 SUPPORT MANY RESEARCH FOCUS 4354 03:05:23,107 --> 03:05:25,009 AREAS AS WELL SUCH AS DIAGNOSTIC 4355 03:05:25,009 --> 03:05:28,012 TECHNOLOGIES, PHARMACEUTICALS 4356 03:05:28,012 --> 03:05:30,481 INCLUDING SMALL MOLECULES AND 4357 03:05:30,481 --> 03:05:34,652 BIOLOG 4358 03:05:34,652 --> 03:05:38,255 BIOLOGICS, AND TREAT PAIN. SO I 4359 03:05:38,255 --> 03:05:40,157 WILL NOW FOCUS ON THE DEVICES 4360 03:05:40,157 --> 03:05:42,293 PROGRAM. IN THIS PROGRAM OUR 4361 03:05:42,293 --> 03:05:43,761 GOAL IS TO SUPPORT NEXT 4362 03:05:43,761 --> 03:05:46,097 GENERATION TECHNOLOGIES TO 4363 03:05:46,097 --> 03:05:49,567 DIAGNOSE AND TREAT PAIN BY 4364 03:05:49,567 --> 03:05:50,701 SUPPORTING THE DEVELOPMENT, 4365 03:05:50,701 --> 03:05:52,837 TRANSLATION AND OPTIMIZATION OF 4366 03:05:52,837 --> 03:05:55,973 SAFE DEVICES. OUR PROGRAMS SPAN 4367 03:05:55,973 --> 03:05:58,576 THE RESEARCH SPACE FROM DEVICE 4368 03:05:58,576 --> 03:05:59,977 DEVELOPMENT THROUGH DEVICE 4369 03:05:59,977 --> 03:06:01,278 OPTIMIZATION AND CLINICAL TRIALS 4370 03:06:01,278 --> 03:06:03,314 AND THIS IS A FOCUS AREA FOR 4371 03:06:03,314 --> 03:06:06,784 HEAL BECAUSE WE BELIEVE DEVICES 4372 03:06:06,784 --> 03:06:12,289 REPRESENT FARM SITE -- 4373 03:06:12,289 --> 03:06:13,991 PHARMACEUTICAL APPROACHES WITH 4374 03:06:13,991 --> 03:06:17,061 LITTLE TO KNOW ADDICTION 4375 03:06:17,061 --> 03:06:17,962 LIABILITY. 4376 03:06:17,962 --> 03:06:19,964 SO WITHIN THIS PROGRAM THE FIRST 4377 03:06:19,964 --> 03:06:23,968 FUNDING OPPORTUNITY I WANT TO 4378 03:06:23,968 --> 03:06:24,602 HIGHLIGHT, WE SUPPORT 4379 03:06:24,602 --> 03:06:27,404 PRECLINICAL TECHNOLOGY 4380 03:06:27,404 --> 03:06:28,906 DEVELOPMENT, THIS R 18 PROGRAM 4381 03:06:28,906 --> 03:06:30,341 OFFERS THREE YEAR GRANTS TO 4382 03:06:30,341 --> 03:06:31,976 SUPPORT THE DEVELOPMENT OF 4383 03:06:31,976 --> 03:06:33,911 CLINICAL GRADE PROTOTYPE DEVICE 4384 03:06:33,911 --> 03:06:36,213 FOR THE DIAGNOSIS AND TREATMENT 4385 03:06:36,213 --> 03:06:38,015 OF PAIN IN OPIOID USE DISORDER 4386 03:06:38,015 --> 03:06:39,950 AND THROUGH THIS FUNDING WE WANT 4387 03:06:39,950 --> 03:06:41,485 TO FACILITATE THE DEVELOPMENT OF 4388 03:06:41,485 --> 03:06:44,789 NEW DEVICES UP TO THE STATE OF 4389 03:06:44,789 --> 03:06:45,856 READINESS FOR HUMAN TESTING 4390 03:06:45,856 --> 03:06:47,825 THESE ARE NOT HYPOTHESIS DRIVEN 4391 03:06:47,825 --> 03:06:51,962 AND CAN FOCUS ON EARLY TO MID 4392 03:06:51,962 --> 03:06:53,931 STAGE ENGINEERING DEVELOPMENT, 4393 03:06:53,931 --> 03:06:56,267 PRECLINICAL ACTIVITIES THROUGH 4394 03:06:56,267 --> 03:06:58,269 MODELING STUDIES AS WELL AS 4395 03:06:58,269 --> 03:07:01,739 PROOF OF CONCEPT TESTING IN 4396 03:07:01,739 --> 03:07:03,974 ANIMALS. THIS PROGRAM IS LED BY 4397 03:07:03,974 --> 03:07:06,277 MY COLLEAGUE DR. MARIA SO FEEL 4398 03:07:06,277 --> 03:07:09,880 FREE TO REACH OUT WITH QUESTIONS 4399 03:07:09,880 --> 03:07:12,082 ABOUT THIS PROGRAM. THE NEXT 4400 03:07:12,082 --> 03:07:15,052 STAGE OF OUR PROGRAM SUPPORTS 4401 03:07:15,052 --> 03:07:16,487 THE TRANSLATION OF YOUR 4402 03:07:16,487 --> 03:07:18,389 TECHNOLOGY TO CLINICAL USE WE DO 4403 03:07:18,389 --> 03:07:22,793 THIS THROUGH A PARTNERSHIP WITH 4404 03:07:22,793 --> 03:07:24,562 NIH BLUEPRINT MED TECH PROGRAM. 4405 03:07:24,562 --> 03:07:26,363 BLUEPRINT MED TECH ACCELERATES 4406 03:07:26,363 --> 03:07:28,799 THE DEVELOPMENT OF CUTTING EDGE 4407 03:07:28,799 --> 03:07:30,267 MEDICAL DEVICES. 4408 03:07:30,267 --> 03:07:33,170 THE HEAL INITIATIVE IS 4409 03:07:33,170 --> 03:07:33,771 PARTICIPATING IN THIS PROGRAM 4410 03:07:33,771 --> 03:07:35,472 AND IS SEEKING TECHNOLOGIES FOR 4411 03:07:35,472 --> 03:07:38,509 PAIN AND OPIOID USE DISORDER 4412 03:07:38,509 --> 03:07:40,778 THROUGH THESE GRANTS WE EXPECT 4413 03:07:40,778 --> 03:07:42,079 YOU TO COMPLETE THE VALIDATION 4414 03:07:42,079 --> 03:07:44,682 OF YOUR MEDICAL DEVICE, PERFORM 4415 03:07:44,682 --> 03:07:47,017 IDE ENABLING STUDIES AND SEEK 4416 03:07:47,017 --> 03:07:48,319 IRB APPROVAL TO INITIATE AN 4417 03:07:48,319 --> 03:07:51,455 EARLY STAGE CLINICAL TRIAL ON 4418 03:07:51,455 --> 03:07:55,826 YOUR TECHNOLOGY. THIS PAGE 4419 03:07:55,826 --> 03:07:57,061 ILLUSTRATES THE TWO PHASES OF 4420 03:07:57,061 --> 03:08:00,231 THE PROGRAM. THE EARLIER STAGE 4421 03:08:00,231 --> 03:08:02,066 DEVELOPMENT PORTION OF THE 4422 03:08:02,066 --> 03:08:03,234 PROGRAM SUPPORTS PRECLINICAL 4423 03:08:03,234 --> 03:08:06,103 PROJECTS TO OPTIMIZE YOUR 4424 03:08:06,103 --> 03:08:06,871 TECHNOLOGY AND ITS 4425 03:08:06,871 --> 03:08:07,504 COMMERCIALIZATION POTENTIAL. 4426 03:08:07,504 --> 03:08:11,041 THIS PART OF THE PROGRAM IS PART 4427 03:08:11,041 --> 03:08:15,846 OF THE UP CUE BAY TOR HUBS. 4428 03:08:15,846 --> 03:08:16,914 YOU CAN FIND OUT MORE ABOUT THIS 4429 03:08:16,914 --> 03:08:18,282 PROGRAM AND THE APPLICATION 4430 03:08:18,282 --> 03:08:22,519 PROCESS BY GOING TO BLUEPRINT 4431 03:08:22,519 --> 03:08:22,887 NEUROTECH.ORG. 4432 03:08:22,887 --> 03:08:27,992 THE LATER TRANSLATIONAL PHASE OF 4433 03:08:27,992 --> 03:08:29,026 THE PROGRAM SUPPORTS THE WORK 4434 03:08:29,026 --> 03:08:30,961 AND APPROVALS TO CONDUCT AN 4435 03:08:30,961 --> 03:08:32,863 EARLY STAGE CLINICAL TRIAL WITH 4436 03:08:32,863 --> 03:08:36,267 YOUR DEVICE INTERVENTION TO 4437 03:08:36,267 --> 03:08:38,602 DEMONSTRATE SAFETY AND BEGIN 4438 03:08:38,602 --> 03:08:40,704 EXAMINING THE EFFICACY. THESE 4439 03:08:40,704 --> 03:08:43,107 PROJECTS ARE SUPPORTED THROUGH 4440 03:08:43,107 --> 03:08:49,813 TRADITIONAL AGREEMENT AWARDS, 4441 03:08:49,813 --> 03:08:50,948 ANOTHER VERSION SPECIFICALLY FOR 4442 03:08:50,948 --> 03:08:51,949 SMALL BUSINESSES. IF YOU 4443 03:08:51,949 --> 03:08:54,418 RECEIVE AN AWARD THROUGH THE 4444 03:08:54,418 --> 03:08:55,185 BLUEPRINT MED TECH PROGRAM YOU 4445 03:08:55,185 --> 03:08:58,656 CAN GAIN ACCESS TO ADDITIONAL 4446 03:08:58,656 --> 03:09:00,724 THREE RESOURCES THAT NEED IN THE 4447 03:09:00,724 --> 03:09:01,125 TRANSLATION AND 4448 03:09:01,125 --> 03:09:02,893 COMMERCIALIZATION OF YOUR 4449 03:09:02,893 --> 03:09:03,961 TECHNOLOGY. THESE INCLUDE 4450 03:09:03,961 --> 03:09:05,863 SERVICES SUCH AS DESIGN, 4451 03:09:05,863 --> 03:09:08,832 PROTOTYPING AND BENCH TESTING, 4452 03:09:08,832 --> 03:09:10,668 CONSULTANTS FOR BUSINESS 4453 03:09:10,668 --> 03:09:12,803 DEVELOPMENT. REGULATORY 4454 03:09:12,803 --> 03:09:15,773 COMPLIANCE AND QUALITY SYSTEM 4455 03:09:15,773 --> 03:09:22,513 DEVELOPMENT. AS WELL AS BY OWE 4456 03:09:22,513 --> 03:09:23,247 CO 4457 03:09:23,247 --> 03:09:24,281 BIO COMPATIBILITY. OUR RESEARCH 4458 03:09:24,281 --> 03:09:27,017 PROGRAM OFFERS FIVE YEAR GRANTS 4459 03:09:27,017 --> 03:09:28,552 TO SUPPORT INTERDISCIPLINARY 4460 03:09:28,552 --> 03:09:31,889 RESEARCH TO INVESTIGATE THE 4461 03:09:31,889 --> 03:09:32,623 MECHANISMS UNDERLYING WITH 4462 03:09:32,623 --> 03:09:35,092 MEDICAL DEVICES THE OVERALL GOAL 4463 03:09:35,092 --> 03:09:36,827 HERE IS OPTIMIZATION OF 4464 03:09:36,827 --> 03:09:37,661 THERAPEUTIC OUTCOMES FOR 4465 03:09:37,661 --> 03:09:39,596 PATIENTS IN PAIN. THE 4466 03:09:39,596 --> 03:09:40,497 MOTIVATION IS THAT ALTHOUGH 4467 03:09:40,497 --> 03:09:42,333 THERE ARE MANY DEVICES ON THE 4468 03:09:42,333 --> 03:09:47,438 MARKET FOR TREETH TREATING PAIN 4469 03:09:47,438 --> 03:09:50,207 MANY LACK THE RATIONALE FOR HOW 4470 03:09:50,207 --> 03:09:51,976 THEY WORK. BY DEVELOPING A 4471 03:09:51,976 --> 03:09:52,910 BETTER UNDERSTANDING OF 4472 03:09:52,910 --> 03:09:54,712 MECHANISMS WE AIM TO OPTIMIZE 4473 03:09:54,712 --> 03:09:58,749 THESE THERAPIES TO IMPROVE THEIR 4474 03:09:58,749 --> 03:09:59,984 EFFICACY. THESE ARE TEAM 4475 03:09:59,984 --> 03:10:01,185 SCIENCE GRANTS THAT ALLOW 4476 03:10:01,185 --> 03:10:02,753 RESEARCH IN THE PRECLINICAL OR 4477 03:10:02,753 --> 03:10:06,023 CLINICAL SPACE AND YOU CAN USE A 4478 03:10:06,023 --> 03:10:09,126 COMBINATION OF TECHNIQUES SUCH 4479 03:10:09,126 --> 03:10:20,471 AS ANIMAL STUD DI-DEE DID-- STD 4480 03:10:20,471 --> 03:10:21,638 HOW THAT INFORMATION CAN BE USED 4481 03:10:21,638 --> 03:10:27,111 TO IMPROVE CARE IN THE CLINIC. 4482 03:10:27,111 --> 03:10:30,280 I ALSO WANT TO HIGHLIGHT THAT 4483 03:10:30,280 --> 03:10:31,215 HEAL HAS ITS FUNDING 4484 03:10:31,215 --> 03:10:32,950 OPPORTUNITIES FOR PAIN 4485 03:10:32,950 --> 03:10:34,184 MANAGEMENT. THESE ARE PHASE ONE 4486 03:10:34,184 --> 03:10:38,022 AND PHASE TWO SVIR AND STTR 4487 03:10:38,022 --> 03:10:41,425 AWARDS THAT SUPPORT SMALL 4488 03:10:41,425 --> 03:10:43,494 BUSINESSES FOR PAIN MANAGEMENT. 4489 03:10:43,494 --> 03:10:44,995 WE HAVE A DUE DATE FOR THIS 4490 03:10:44,995 --> 03:10:45,929 PROGRAM COMING UP IN SEPTEMBER 4491 03:10:45,929 --> 03:10:48,499 AND YOU CAN REACH OUT TO MY 4492 03:10:48,499 --> 03:10:51,902 COLLEAGUE DR. EMILY FOR MORE 4493 03:10:51,902 --> 03:10:53,704 INFORMATION. ONE FINAL RESOURCE 4494 03:10:53,704 --> 03:10:56,907 I WANT TO HIGHLIGHT IS THE HEAL 4495 03:10:56,907 --> 03:10:57,574 INITIATIVE PURPOSE NETWORK. YOU 4496 03:10:57,574 --> 03:11:00,010 CAN THINK OF THIS A SOCIAL 4497 03:11:00,010 --> 03:11:01,912 NETWORK MORE PAIN RESEARCHERS 4498 03:11:01,912 --> 03:11:03,981 WHERE YOU CAN CONNECT WITH 4499 03:11:03,981 --> 03:11:04,615 COLLEAGUES, ACCESS INFORMATION 4500 03:11:04,615 --> 03:11:06,984 ABOUT PAIN FUNDING. 4501 03:11:06,984 --> 03:11:09,453 ACCESS INFORMATION ABOUT 4502 03:11:09,453 --> 03:11:12,289 NETWORKING OPPORTUNITIES, AND 4503 03:11:12,289 --> 03:11:13,690 OTHER UPCOMING PAIN CONFERENCES 4504 03:11:13,690 --> 03:11:14,992 AND EVENTS. THIS IS OPEN TO 4505 03:11:14,992 --> 03:11:16,326 ANYONE IN THE RESEARCH SPACE SO 4506 03:11:16,326 --> 03:11:18,295 YOU DO NOT NEED TO HAVE HEAL 4507 03:11:18,295 --> 03:11:19,363 FUNDING TO BE PART OF THIS 4508 03:11:19,363 --> 03:11:20,697 NETWORK SO WE ENCOURAGE YOU TO 4509 03:11:20,697 --> 03:11:23,901 JOIN THE NETWORK BY GOING TO 4510 03:11:23,901 --> 03:11:26,470 PAIN RESEARCHERS.COM AND SIGNING 4511 03:11:26,470 --> 03:11:28,972 UP. WITH THAT I'D LIKE TO 4512 03:11:28,972 --> 03:11:32,242 RECOGNIZE THE NINDS 4513 03:11:32,242 --> 03:11:34,611 TRANSLATIONAL NEURAL DEVICES 4514 03:11:34,611 --> 03:11:37,081 TEAM. AND THE PROGRAMS TO 4515 03:11:37,081 --> 03:11:37,881 SUPPORT DEVELOPMENT AND 4516 03:11:37,881 --> 03:11:40,517 TRANSLATION OF MEDICAL DEVICES. 4517 03:11:40,517 --> 03:11:43,487 AND THE BIOLOGICAL DISORDERS. 4518 03:11:43,487 --> 03:11:44,755 PLEASE REACH OUT TO US AND THANK 4519 03:11:44,755 --> 03:11:49,827 YOU FOR YOUR TIME. 4520 03:11:49,827 --> 03:11:55,866 >> THANK YOU SO MUCH DR. HIGH 4521 03:11:55,866 --> 03:11:58,202 HUDAK. WE WILL GO ON TO THE 4522 03:11:58,202 --> 03:11:59,937 DISCUSSION CENTER. 4523 03:11:59,937 --> 03:12:03,073 DR. GOLDSTEIN. DR. GOLDSTEIN IS 4524 03:12:03,073 --> 03:12:05,642 GOING TO MODERATE THE DISCUSSION 4525 03:12:05,642 --> 03:12:08,245 SECTION AND WE WILL EXTEND OUR 4526 03:12:08,245 --> 03:12:13,317 MEETING UNTIL 5:15. OKAY. 4527 03:12:13,317 --> 03:12:16,386 DR. GOLDSTEIN TAKE IT AWAY. ANY 4528 03:12:16,386 --> 03:12:18,889 DUE TO A LIMITED AMOUNT OF TIME 4529 03:12:18,889 --> 03:12:20,624 I WANTED TO POSE A COUPLE OF 4530 03:12:20,624 --> 03:12:22,726 QUESTIONS TO OUR PANELISTS AND 4531 03:12:22,726 --> 03:12:23,994 SEE IF THEY CAN SHED SOME LIGHT 4532 03:12:23,994 --> 03:12:26,396 ON SOME IMPORTANT QUESTIONS THAT 4533 03:12:26,396 --> 03:12:27,831 WE'VE COME UP WITH OVER THE LAST 4534 03:12:27,831 --> 03:12:30,501 SEVERAL DAYS. THE FIRST ONE I 4535 03:12:30,501 --> 03:12:32,169 SORT OF WOULD LIKE ANY PANELIST 4536 03:12:32,169 --> 03:12:34,738 TO JOIN IN AND ANSWER IS THAT 4537 03:12:34,738 --> 03:12:37,107 WHY DO YOU FEEL THERE ARE 4538 03:12:37,107 --> 03:12:39,977 RELATIVELY FEW RESEARCH 4539 03:12:39,977 --> 03:12:42,613 PROPOSALS FOR GYNECOLOGICAL PAIN 4540 03:12:42,613 --> 03:12:44,381 DISORDERS? BASICALLY, WHAT ARE 4541 03:12:44,381 --> 03:12:47,518 THE GAPS EITHER CONCEPTUAL, 4542 03:12:47,518 --> 03:12:51,955 PRACTICAL OR TECHNICAL AND 4543 03:12:51,955 --> 03:12:54,057 CHALLENGES THAT YOU'RE FACING 4544 03:12:54,057 --> 03:12:57,661 THAT MAY IMPEDE YOUR WANTING TO 4545 03:12:57,661 --> 03:13:02,065 DO OR ABILITY TO HAVE 4546 03:13:02,065 --> 03:13:02,699 GYNECOLOGICAL PAIN RESOURCE. 4547 03:13:02,699 --> 03:13:08,005 ANY OF THE PANELISTS HAVE ANY 4548 03:13:08,005 --> 03:13:15,412 OPINIONS ON THAT QUESTION? 4549 03:13:15,412 --> 03:13:17,114 >> HI. WELL I CAN SPEAK TO JUST 4550 03:13:17,114 --> 03:13:20,350 ONE ASPECT THAT I THINK HAS 4551 03:13:20,350 --> 03:13:23,887 IMPEDED SOME RESEARCH. I -- MY 4552 03:13:23,887 --> 03:13:24,788 RESEARCH FOCUSES A LOT ON THE 4553 03:13:24,788 --> 03:13:28,892 MAN -- MENSTRUAL CYCLE. 4554 03:13:28,892 --> 03:13:30,727 JUST ASSESSING THE MENSTRUAL 4555 03:13:30,727 --> 03:13:32,396 CYCLE IS VERY CHALLENGING IN A 4556 03:13:32,396 --> 03:13:33,530 RESEARCH CONTEXT. 4557 03:13:33,530 --> 03:13:37,134 IT REQUIRES A LOT OF RESOURCES, 4558 03:13:37,134 --> 03:13:39,570 A LOT OF FEEDBACK FROM 4559 03:13:39,570 --> 03:13:41,104 PARTICIPANTS AND TO ACCURATELY 4560 03:13:41,104 --> 03:13:42,105 PHASE THE MENSTRUAL CYCLE WHICH 4561 03:13:42,105 --> 03:13:44,241 I THINK IS A REALLY IMPORTANT 4562 03:13:44,241 --> 03:13:46,743 PART OF GYNECOLOGICAL PAIN 4563 03:13:46,743 --> 03:13:49,479 RESEARCH IT'S A LOT MORE THAN I 4564 03:13:49,479 --> 03:13:51,548 THINK WHAT MOST PEOPLE WANT TO 4565 03:13:51,548 --> 03:13:55,285 GET INVOLVED IN. THAT BEING 4566 03:13:55,285 --> 03:13:56,853 SAID IT'S ABSOLUTELY IMPORTANT 4567 03:13:56,853 --> 03:14:01,592 AND IT'S ABSOLUTELY CRITICAL TO 4568 03:14:01,592 --> 03:14:03,527 BETTER UNDERSTANDING WOMEN'S 4569 03:14:03,527 --> 03:14:04,094 GYNECOLOGICAL PAIN AND ALSO 4570 03:14:04,094 --> 03:14:06,296 TREATMENT AND APPROPRIATE CARE. 4571 03:14:06,296 --> 03:14:09,733 >> COMPLETELY AGREE. DO YOU 4572 03:14:09,733 --> 03:14:12,469 FIND THAT IT'S DIFFICULT TO GET 4573 03:14:12,469 --> 03:14:15,906 PARTICIPANTS TO PARTICIPATE IN 4574 03:14:15,906 --> 03:14:18,408 CLINICAL TRIALS OR THEY'RE MORE 4575 03:14:18,408 --> 03:14:22,446 THAN HAPPY TO FIND THAT IT'S 4576 03:14:22,446 --> 03:14:24,915 DIFFICULT TO GET APPROVAL OR 4577 03:14:24,915 --> 03:14:28,685 WHAT BARRIERS HAVE YOU RUN INTO 4578 03:14:28,685 --> 03:14:29,052 IF ANY? 4579 03:14:29,052 --> 03:14:31,888 >> FOR MY RESEARCH WHICH IS 4580 03:14:31,888 --> 03:14:33,857 FOCUSED PRIMARILY ON ADOLESCENTS 4581 03:14:33,857 --> 03:14:37,027 AND YOUNG ADULTS I DON'T KNOW IN 4582 03:14:37,027 --> 03:14:39,663 COMPARISON TO THE ADULT 4583 03:14:39,663 --> 03:14:41,632 POPULATION BUT MANY OF THESE 4584 03:14:41,632 --> 03:14:44,468 YOUNG INDIVIDUALS ARE ALREADY 4585 03:14:44,468 --> 03:14:48,405 TRACKING THEIR MAN STRUL PSY 4586 03:14:48,405 --> 03:14:51,708 MENSTRUAL CYCLE SO THAT'S A GOOD 4587 03:14:51,708 --> 03:14:51,975 BENEFIT. 4588 03:14:51,975 --> 03:14:52,843 WE DEVELOP CLOSE RELATIONSHIPS 4589 03:14:52,843 --> 03:14:54,645 WITH THESE PARTICIPANTS, WE'RE 4590 03:14:54,645 --> 03:14:57,848 IN CONTACT WITH THEM FREQUENTLY 4591 03:14:57,848 --> 03:14:59,016 AND THAT HELPS WITH THE TRACKING 4592 03:14:59,016 --> 03:15:01,785 AND THE, YOU KNOW, USING VARIOUS 4593 03:15:01,785 --> 03:15:03,754 MEASURES TO ASSESS OVULATION AND 4594 03:15:03,754 --> 03:15:05,722 THOSE IMPORTANT ASPECTS AND SO 4595 03:15:05,722 --> 03:15:08,692 IT'S A REAL COMMITMENT TO THAT 4596 03:15:08,692 --> 03:15:12,029 PART OF THE RESEARCH. THAT I 4597 03:15:12,029 --> 03:15:15,766 THINK IS NOT CONSIDERED AS MUCH 4598 03:15:15,766 --> 03:15:17,501 IN SOME OTHER AREAS THAT ARE, 4599 03:15:17,501 --> 03:15:19,970 YOU KNOW, LESS KIND OF DIRECTLY 4600 03:15:19,970 --> 03:15:21,838 FOCUSED ON THE MENSTRUAL CYCLE. 4601 03:15:21,838 --> 03:15:25,509 >> HOW ABOUT SOME OF OUR OTHER 4602 03:15:25,509 --> 03:15:27,878 PANELISTS? WHAT BARRIERS THAT 4603 03:15:27,878 --> 03:15:30,747 YOU MAY HAVE FACED OR MAYBE SOME 4604 03:15:30,747 --> 03:15:31,581 SOLUTIONS TO -- YOU'VE BEEN ABLE 4605 03:15:31,581 --> 03:15:35,652 TO OVERCOME SOME OF THESE 4606 03:15:35,652 --> 03:15:41,558 BARRIERS? HAS ANYONE HAD 4607 03:15:41,558 --> 03:15:42,492 DIFFICULTY GETTING PEOPLE TO 4608 03:15:42,492 --> 03:15:44,127 PARTICIPATE IN CLINICAL TRIALS 4609 03:15:44,127 --> 03:15:48,332 MAYBE BECAUSE OF STIGMA OR ANY 4610 03:15:48,332 --> 03:15:49,933 OTHER REASONS? THAT THEY'VE NOT 4611 03:15:49,933 --> 03:15:53,403 BEEN ABLE TO GET PEOPLE OR THEY 4612 03:15:53,403 --> 03:15:57,374 REALLY -- THAT CAME OUT OF A 4613 03:15:57,374 --> 03:16:01,545 DIFFICULT PROBLEM? MAYBE I'M 4614 03:16:01,545 --> 03:16:06,717 NOT ASKING THE RIGHT QUESTIONS. 4615 03:16:06,717 --> 03:16:08,552 MAYBE, OKAY, I'LL JUMP ONTO THE 4616 03:16:08,552 --> 03:16:09,886 NEXT POSSIBLE QUESTION, WE HEARD 4617 03:16:09,886 --> 03:16:13,523 A LOT OF REALLY AMAZING THINGS 4618 03:16:13,523 --> 03:16:15,459 TODAY. AND NOT TOOTING OUR OWN 4619 03:16:15,459 --> 03:16:16,960 HORN IF POSSIBLE. WHAT ARE THE 4620 03:16:16,960 --> 03:16:18,962 THINGS YOU'RE MOST EXCITED ABOUT 4621 03:16:18,962 --> 03:16:20,230 THAT YOU MAY HAVE HEARD TODAY 4622 03:16:20,230 --> 03:16:22,399 AND MAYBE SOME THINGS THAT WE 4623 03:16:22,399 --> 03:16:25,335 HAVEN'T TALKED ABOUT TODAY THAT 4624 03:16:25,335 --> 03:16:28,505 YOU'RE REALLY EXCITED ABOUT 4625 03:16:28,505 --> 03:16:31,708 MOVING FORWARD. IN 4626 03:16:31,708 --> 03:16:35,879 GYNECOLOGICAL PAIN RESEARCH. 4627 03:16:35,879 --> 03:16:39,983 >> I CAN TRY FIRST. I THINK 4628 03:16:39,983 --> 03:16:43,186 PART OF THE THINGS THAT I WAS 4629 03:16:43,186 --> 03:16:43,987 EXCITED ABOUT WAS FIRST OF ALL 4630 03:16:43,987 --> 03:16:46,423 SEEING ALL THESE AMAZING 4631 03:16:46,423 --> 03:16:47,924 SCIENTISTS DOING RESEARCH IN 4632 03:16:47,924 --> 03:16:51,361 THIS AREA, SECOND IS THE NEW 4633 03:16:51,361 --> 03:16:52,796 PIPELINE OF DRUGS THAT ARE 4634 03:16:52,796 --> 03:16:58,602 COMING IN TO REPLACE THE LONG 4635 03:16:58,602 --> 03:17:01,004 USED GENERICS THAT HAVE BEEN 4636 03:17:01,004 --> 03:17:03,540 USED FOR A LONG TIME OFF LABEL. 4637 03:17:03,540 --> 03:17:04,508 SO HOPEFULLY THERE'LL BE 4638 03:17:04,508 --> 03:17:05,842 PRODUCTS THAT WILL BE APPROVED. 4639 03:17:05,842 --> 03:17:08,979 IT WILL HELP APPROVE PRODUCTS 4640 03:17:08,979 --> 03:17:10,881 FOR SPECIFIC INDICATIONS AND NOT 4641 03:17:10,881 --> 03:17:12,215 JUST HAVE OFF LABEL PRESCRIBED 4642 03:17:12,215 --> 03:17:14,217 PRODUCTS. THAT IS CHALLENGING. 4643 03:17:14,217 --> 03:17:15,986 BECAUSE OF REGULATORY. BECAUSE 4644 03:17:15,986 --> 03:17:17,554 THERE IS NOT APPROVED PRODUCTS 4645 03:17:17,554 --> 03:17:21,458 IT'S NOT EASY TO GO A 505B 2 4646 03:17:21,458 --> 03:17:22,926 ROIT SO THAT EXTENDS THE 4647 03:17:22,926 --> 03:17:26,296 REGULATORY PATH TO HAVE THE 4648 03:17:26,296 --> 03:17:27,931 FIRST PRODUCT APPROVED. 4649 03:17:27,931 --> 03:17:29,900 THAT BEING SAID IF IT WERE EASY 4650 03:17:29,900 --> 03:17:31,968 EVERYBODY WOULD DO AND IT 4651 03:17:31,968 --> 03:17:33,670 HOPEFULLY THE FIRST PRODUCT WILL 4652 03:17:33,670 --> 03:17:34,938 OPEN THE DOOR TO MORE AND MORE 4653 03:17:34,938 --> 03:17:38,875 AND MORE TO BE MORE OPTIONS FOR 4654 03:17:38,875 --> 03:17:40,610 INDICATIONS LIKE THESE THAT ARE 4655 03:17:40,610 --> 03:17:44,247 SUCH A NEED. SO VERY NICE TO 4656 03:17:44,247 --> 03:17:45,015 SEE EVERYBODY. 4657 03:17:45,015 --> 03:17:46,516 >> I WOULD LIKE TO SAY I WISH WE 4658 03:17:46,516 --> 03:17:47,951 HAVE THE PROBLEM WITH THE 4659 03:17:47,951 --> 03:17:49,653 CLINICAL TRIALS BECAUSE WE'RE 4660 03:17:49,653 --> 03:17:51,788 JUST GETTING AT ANIMALS BUT 4661 03:17:51,788 --> 03:17:53,857 WE'RE LOOKING TO SEE WHAT WE CAN 4662 03:17:53,857 --> 03:17:58,662 DO TO MANAGE THE SITUATIONS WITH 4663 03:17:58,662 --> 03:17:59,963 NONPHARMACOLOGICAL MEANS TO 4664 03:17:59,963 --> 03:18:02,232 BETTER UNDERSTAND HOW IT AFFECTS 4665 03:18:02,232 --> 03:18:02,866 THE CENTRAL NERVOUS SYSTEM SO 4666 03:18:02,866 --> 03:18:04,434 WE'RE LOOKING FORWARD TO SEEING 4667 03:18:04,434 --> 03:18:06,837 THE RESULTS WE GET FROM OUR 4668 03:18:06,837 --> 03:18:08,405 ANIMAL TRIALS AND AS QUICKLY AS 4669 03:18:08,405 --> 03:18:12,843 POSSIBLE TO PULL TOGETHER THAT 4670 03:18:12,843 --> 03:18:14,578 RELIGION STUDY I DON'T 4671 03:18:14,578 --> 03:18:15,512 ANTICIPATE HAVING DIFFICULTY 4672 03:18:15,512 --> 03:18:16,746 FINDING THE PEOPLE FOR THIS 4673 03:18:16,746 --> 03:18:18,348 CLINICAL STUDY SINCE WHAT WE'RE 4674 03:18:18,348 --> 03:18:19,449 DOING IS FAIRLY NON RISK. IT'S 4675 03:18:19,449 --> 03:18:21,852 LOW IMPACT. AND TREMENDOUS 4676 03:18:21,852 --> 03:18:23,487 NUMBER OF PEOPLE THAT EXIST THAT 4677 03:18:23,487 --> 03:18:27,257 ARE CLAMBERING FOR A SOLUTION. 4678 03:18:27,257 --> 03:18:31,328 SO IT'S JUST TIME FOR US, THAT'S 4679 03:18:31,328 --> 03:18:36,132 BIGGEST CHALLENGE. 4680 03:18:36,132 --> 03:18:38,835 >> FOR THE PEOPLE DOING RESEARCH 4681 03:18:38,835 --> 03:18:44,140 IN ENDOMETRIOSIS, HAVE YOU FOUND 4682 03:18:44,140 --> 03:18:48,078 MANY WILLING PARTICIPANTS OR ANY 4683 03:18:48,078 --> 03:18:51,114 BARRIERS TO YOUR -- ANY 4684 03:18:51,114 --> 03:18:54,084 PARTICIPATION IN YOUR CLINICAL 4685 03:18:54,084 --> 03:18:57,821 TRIALS OR AGAIN ANY BARRIERS 4686 03:18:57,821 --> 03:18:59,623 THAT YOU MIGHT HAVE FIND OR ANY 4687 03:18:59,623 --> 03:19:03,960 SOLUTIONS TO SOME OF THOSE 4688 03:19:03,960 --> 03:19:07,497 BARRIE 4689 03:19:07,497 --> 03:19:07,764 BARRIERS? 4690 03:19:07,764 --> 03:19:09,933 >> CAN I SPEAK THE TRIAL THAT 4691 03:19:09,933 --> 03:19:12,168 WE'RE DOING RIGHT NOW IT'S 4692 03:19:12,168 --> 03:19:14,404 FAIRLY BENIGN. IT'S 4693 03:19:14,404 --> 03:19:15,138 PARTICIPANTS CAN GENERALLY JUST 4694 03:19:15,138 --> 03:19:16,306 KIND OF FILL OUT QUESTIONNAIRES 4695 03:19:16,306 --> 03:19:19,409 ON THEIR OWN. SO IT'S NOT A 4696 03:19:19,409 --> 03:19:20,810 VERY BURDENSOME TYPE OF STUDY 4697 03:19:20,810 --> 03:19:23,947 BUT WHAT WE DO FIND IS THAT, SO 4698 03:19:23,947 --> 03:19:27,083 MANY WOMEN OUT THERE ARE HIGHLY 4699 03:19:27,083 --> 03:19:28,718 INVESTED IN PARTICIPATING, AT 4700 03:19:28,718 --> 03:19:31,254 LEAST IN THIS PARTICULAR 4701 03:19:31,254 --> 03:19:32,722 RESEARCH. I THINK THE ONLY 4702 03:19:32,722 --> 03:19:34,891 BARRIER IS JUST THE TIME 4703 03:19:34,891 --> 03:19:35,592 COMMITMENT OBVIOUSLY, PEOPLE 4704 03:19:35,592 --> 03:19:37,427 HAVE VERY BUSY LIVES BUT, YOU 4705 03:19:37,427 --> 03:19:41,798 KNOW, YOU FIND A LOT OF WOMEN 4706 03:19:41,798 --> 03:19:42,365 ARE REALLY WILLING TO DO 4707 03:19:42,365 --> 03:19:45,735 ANYTHING THAT THEY NEED TO DO IN 4708 03:19:45,735 --> 03:19:47,971 ORDER TO HELP PROGRESS TREATMENT 4709 03:19:47,971 --> 03:19:50,340 AND FIND WAYS OF BEING ABLE TO 4710 03:19:50,340 --> 03:19:52,475 KIND OF DEAL WITH SOME OF THE 4711 03:19:52,475 --> 03:19:53,577 SYMPTOMS THAT THEY'RE HAVING. 4712 03:19:53,577 --> 03:19:55,345 SO WE HAVEN'T NECESSARILY 4713 03:19:55,345 --> 03:20:00,717 ENCOUNTERED A LOT OF ISSUES. 4714 03:20:00,717 --> 03:20:04,821 NOW I WILL SPEAK TO DR. PAYNE'S 4715 03:20:04,821 --> 03:20:06,389 WORK. I USED TO DO RESEARCH 4716 03:20:06,389 --> 03:20:08,224 BACK IN THE DAY AND I CAN ATTEST 4717 03:20:08,224 --> 03:20:10,760 TO HOW BURDENSOME THAT ACTUALLY 4718 03:20:10,760 --> 03:20:12,062 IS. IT'S VERY TIME-CONSUMING 4719 03:20:12,062 --> 03:20:13,563 BUT YOU HAVE TO CAPTURE PEOPLE 4720 03:20:13,563 --> 03:20:16,866 AT CERTAIN TIME POINTS AND 4721 03:20:16,866 --> 03:20:23,139 YOU'RE ASKING WOMEN TO DO A LOT 4722 03:20:23,139 --> 03:20:24,741 OF WORK REPORTING ON THEIR 4723 03:20:24,741 --> 03:20:26,076 MENSTRUAL CYCLE AND WHATEVER 4724 03:20:26,076 --> 03:20:27,410 ELSE IS INVOLVED BUT THESE ARE 4725 03:20:27,410 --> 03:20:28,778 THE KIND OF STUDIES THAT WE NEED 4726 03:20:28,778 --> 03:20:31,748 TO BE DOING AND I ALWAYS THINK 4727 03:20:31,748 --> 03:20:34,851 THAT SOMETIMES FOR PEOPLE THE 4728 03:20:34,851 --> 03:20:35,952 BURDEN CAN BECOME TOO MUCH 4729 03:20:35,952 --> 03:20:38,188 ESPECIALLY IF THEY HAVE VERY 4730 03:20:38,188 --> 03:20:40,590 BUSY LIVES BUT, YOU KNOW, IT'S 4731 03:20:40,590 --> 03:20:42,192 JUST KIND OF PART OF DOING THAT 4732 03:20:42,192 --> 03:20:46,630 TYPE OF RESEARCH. SO, YES, I 4733 03:20:46,630 --> 03:20:48,331 VERY MUCH UNDERSTAND SOME OF 4734 03:20:48,331 --> 03:20:50,100 THAT BACKGROUND. HOW RIGOROUS 4735 03:20:50,100 --> 03:20:56,806 THOSE PROTOCOLS CAN ACTUALLY BE. 4736 03:20:56,806 --> 03:20:58,074 >> I WILL SAY THAT I THINK WE'VE 4737 03:20:58,074 --> 03:20:59,476 MADE SOME PROGRESS IN THIS AREA 4738 03:20:59,476 --> 03:21:02,545 IN TERMS OF USE OF DIGITAL 4739 03:21:02,545 --> 03:21:06,549 HEALTH TECHNOLOGIES. AS OPPOSED 4740 03:21:06,549 --> 03:21:09,886 TO VERY NOT THAT LONG AGO BUT 4741 03:21:09,886 --> 03:21:10,854 BACK IN THE DAY IT WAS ALL BY 4742 03:21:10,854 --> 03:21:13,089 HAND AND DIARIES. AND THE 4743 03:21:13,089 --> 03:21:15,959 AMOUNT OF MISSING DATA REALLY 4744 03:21:15,959 --> 03:21:17,293 CALLED INTO QUESTION SOME OF THE 4745 03:21:17,293 --> 03:21:21,164 RESULTS WE WERE SEEING. SO I 4746 03:21:21,164 --> 03:21:23,500 WILL JUST TOSS OUT THAT BIT OF 4747 03:21:23,500 --> 03:21:24,100 HOPE THAT THINGS ARE GETTING 4748 03:21:24,100 --> 03:21:29,739 BETTER. 4749 03:21:29,739 --> 03:21:32,942 >> I WANT TO ADD ONE MORE TOPIC. 4750 03:21:32,942 --> 03:21:37,013 10% OF ALL THE PRODUCTIVE WOMAN, 4751 03:21:37,013 --> 03:21:39,716 BUT OUR ASSOCIATES ARE VERY 4752 03:21:39,716 --> 03:21:42,352 LIMITED AND IT'S VERY 4753 03:21:42,352 --> 03:21:45,855 HETEROGENOUS OF WHEN WE TRY TO 4754 03:21:45,855 --> 03:21:48,391 TRANSLATIONAL STUDY I THINK 4755 03:21:48,391 --> 03:21:50,794 COMPARED TO THE OTHER. I THINK 4756 03:21:50,794 --> 03:21:53,329 THAT OUR RESOURCES ARE VERY 4757 03:21:53,329 --> 03:21:54,998 LIMITED TO DO THAT KIND OF 4758 03:21:54,998 --> 03:21:59,069 TRANSLATIONAL STUDY AND THE 4759 03:21:59,069 --> 03:22:03,473 METHOD IS ALSO VERY LIMITED. I 4760 03:22:03,473 --> 03:22:06,242 TRIED TO STUDY IN THE CLINICAL 4761 03:22:06,242 --> 03:22:10,313 ANIMAL. THERE IS NO METHOD. SO 4762 03:22:10,313 --> 03:22:17,654 WE NEED TO MORE BASIC KIND OF -- 4763 03:22:17,654 --> 03:22:19,055 MORE COMPARED TO THE OTHER TO 4764 03:22:19,055 --> 03:22:25,095 DEVELOP THAT KIND OF A BASIC 4765 03:22:25,095 --> 03:22:29,666 RESOUR 4766 03:22:29,666 --> 03:22:29,933 RESOURCE. 4767 03:22:29,933 --> 03:22:30,567 >> I MAY SWITCH TO A DIFFERENT 4768 03:22:30,567 --> 03:22:37,941 TOPIC NOW. BECAUSE IT'S SUCH A 4769 03:22:37,941 --> 03:22:39,909 BIG PROBLEM IN SOCIETY TODAY 4770 03:22:39,909 --> 03:22:43,613 WHICH IS OUR OPIATE CRISIS WHAT 4771 03:22:43,613 --> 03:22:45,115 THERE SOLUTION AND STRATEGIES 4772 03:22:45,115 --> 03:22:48,351 THAT YOU UTILIZE TO PREVENT 4773 03:22:48,351 --> 03:22:50,186 OPIATE MISUSE AND ADDICTION 4774 03:22:50,186 --> 03:22:53,289 RELATE TO DO GYNECOLOGIC PAIN 4775 03:22:53,289 --> 03:22:54,290 GIVEN THAT THESE CAN BE CHRONIC 4776 03:22:54,290 --> 03:22:57,761 PAIN SYNDROMES, SOMETIMES 4777 03:22:57,761 --> 03:23:06,736 WITHOUT ANY SOLUTION. 4778 03:23:06,736 --> 03:23:09,339 >> IT'S PRETTY OBVIOUS. THERMAL 4779 03:23:09,339 --> 03:23:18,414 MODULATION. THANKS FOR ASKING. 4780 03:23:18,414 --> 03:23:20,550 >> ANY OTHER SUGGESTIONS TO 4781 03:23:20,550 --> 03:23:26,189 PREVENT THE USE OF OPIATES AND 4782 03:23:26,189 --> 03:23:28,658 THE PREVENTION OF ADDICTION. OR 4783 03:23:28,658 --> 03:23:30,960 HAVE YOU NOT SEEN THAT MUCH OF A 4784 03:23:30,960 --> 03:23:31,461 PROBLEM IN THIS PATIENT 4785 03:23:31,461 --> 03:23:41,538 POPULATION? OKAY. 4786 03:23:41,538 --> 03:23:41,871 CONSIDERING -- 4787 03:23:41,871 --> 03:23:44,374 >> IF IT'S OKAY -- DR. GOLDSTEIN 4788 03:23:44,374 --> 03:23:46,409 IF IT'S OKAY I WOULD LIKE TO 4789 03:23:46,409 --> 03:23:47,610 ANSWER THE QUESTION ABOUT 4790 03:23:47,610 --> 03:23:51,381 CLINICAL TRIALS FROM THE PATIENT 4791 03:23:51,381 --> 03:23:52,882 PERSPECTIVE. SO I JUST -- I 4792 03:23:52,882 --> 03:23:54,217 THINK THERE'S TWO DIFFERENT 4793 03:23:54,217 --> 03:23:56,085 THINGS THAT I'M SEEING IN TERMS 4794 03:23:56,085 --> 03:23:57,520 OF PATIENTS AND FIRST OF ALL I 4795 03:23:57,520 --> 03:23:59,255 REALLY AGREE WITH WHAT 4796 03:23:59,255 --> 03:24:01,224 DR. PAYNE -- OR SORRY 4797 03:24:01,224 --> 03:24:03,493 DR. BARTLEY ONE OR BOTH OF YOU 4798 03:24:03,493 --> 03:24:04,894 WERE SAYING ABOUT HOW PATIENTS 4799 03:24:04,894 --> 03:24:06,963 ARE VERY INVESTED IN WANTING TO 4800 03:24:06,963 --> 03:24:10,400 SOLVE THESE PROBLEMS AND WANT TO 4801 03:24:10,400 --> 03:24:12,368 VOLUNTEER AND HELP IF THEY HEAR 4802 03:24:12,368 --> 03:24:15,004 ABOUT AN OPPORTUNITY. I THINK 4803 03:24:15,004 --> 03:24:16,139 THERE'S TWO MAIN ISSUES THAT I 4804 03:24:16,139 --> 03:24:17,907 FIND IN TERMS OF THE 4805 03:24:17,907 --> 03:24:20,376 CONVERSATIONS I'M HAVING WITH 4806 03:24:20,376 --> 03:24:22,078 PATIENTS. ONE IS THAT SO MANY 4807 03:24:22,078 --> 03:24:23,947 PATIENTS ARE NOT DIAGNOSED IF 4808 03:24:23,947 --> 03:24:26,015 YOU DON'T HAVE A DIAGNOSIS YOU 4809 03:24:26,015 --> 03:24:26,850 DON'T NECESSARILY HAVE ANYWHERE 4810 03:24:26,850 --> 03:24:29,085 TO GO THAT YOU WOULD SEE ABOUT 4811 03:24:29,085 --> 03:24:31,521 AN -- YOU WOULD HEAR ABOUT AN 4812 03:24:31,521 --> 03:24:33,056 OPPORTUNITY TO PARTICIPATE IN A 4813 03:24:33,056 --> 03:24:34,224 CLINICAL TRIAL AND MANY PATIENTS 4814 03:24:34,224 --> 03:24:36,292 HAVE NORMALIZED THEIR SYMPTOMS 4815 03:24:36,292 --> 03:24:38,361 OR THINK THEIR PAIN, THEIR 4816 03:24:38,361 --> 03:24:39,762 URINARY SYMPTOMS ARE NORMAL AND 4817 03:24:39,762 --> 03:24:41,598 THEIR PAIN IS NORMAL AND THEY 4818 03:24:41,598 --> 03:24:43,666 DON'T ACTUALLY THINK OF 4819 03:24:43,666 --> 03:24:45,435 THEMSELVES AS HAVING A MEDICAL 4820 03:24:45,435 --> 03:24:47,136 CONDITION UNTIL THEY FIND A 4821 03:24:47,136 --> 03:24:48,705 PROVIDER THAT ASKS ABOUT THEIR 4822 03:24:48,705 --> 03:24:49,739 MEDICAL CONDITION UNTIL THEIR 4823 03:24:49,739 --> 03:24:51,975 PAIN GET TO A POINT THAT IS 4824 03:24:51,975 --> 03:24:53,042 COMPLETELY UNTENABLE IF YOU 4825 03:24:53,042 --> 03:24:54,377 DON'T THINK YOU HAVE A MEDICAL 4826 03:24:54,377 --> 03:24:59,482 CONDITION YOUR SH -- YOU'RE NOT 4827 03:24:59,482 --> 03:25:00,383 NECESSARILY LOOKING FOR THE 4828 03:25:00,383 --> 03:25:02,852 RIGHT OPPORTUNITIES TO 4829 03:25:02,852 --> 03:25:04,787 PARTICIPATE IN TRIALS. I THINK 4830 03:25:04,787 --> 03:25:07,290 THAT'S ONE CATEGORY OF PATIENTS 4831 03:25:07,290 --> 03:25:08,591 THAT DON'T KNOW WHAT THEY HAVE. 4832 03:25:08,591 --> 03:25:10,159 THEY'RE EITHER MISDIAGNOSED OR 4833 03:25:10,159 --> 03:25:10,760 NOT DIAGNOSISED. 4834 03:25:10,760 --> 03:25:12,395 ON THE OTHER CATEGORY OF 4835 03:25:12,395 --> 03:25:14,030 PATIENTS THAT ARE ON THE 4836 03:25:14,030 --> 03:25:15,632 OPPOSITE END WHERE THEY'RE 4837 03:25:15,632 --> 03:25:16,699 TRYING LITERALLY EVERYTHING 4838 03:25:16,699 --> 03:25:18,434 UNDER THE SUN AND THEY ARE 4839 03:25:18,434 --> 03:25:20,069 SPENDING HOURS AND HOURS EVERY 4840 03:25:20,069 --> 03:25:22,538 WEEK GOING FOR PHYSICAL THERAPY, 4841 03:25:22,538 --> 03:25:23,406 TRYING SOME NEW TREATMENT, 4842 03:25:23,406 --> 03:25:25,441 TRACKING THEIR SYMPTOMS, 4843 03:25:25,441 --> 03:25:26,142 TRACKING THEIR TREATMENTS AND I 4844 03:25:26,142 --> 03:25:27,076 THINK THOSE PATIENTS ARE KIND OF 4845 03:25:27,076 --> 03:25:29,979 THERE THE OPPOSITE SITUATION 4846 03:25:29,979 --> 03:25:32,115 WHERE IT'S A LITTLE BIT HARD TO 4847 03:25:32,115 --> 03:25:33,349 FIT WITH -- THEY'RE ALREADY 4848 03:25:33,349 --> 03:25:35,551 TRYING SO MANY THINGS THAT IT'S 4849 03:25:35,551 --> 03:25:37,153 HARD TO SAY WHY SHOULD I DO THIS 4850 03:25:37,153 --> 03:25:38,221 ADDITIONAL THING ON TOP OF 4851 03:25:38,221 --> 03:25:41,691 EVERYTHING ELSE THAT I'M TRYING 4852 03:25:41,691 --> 03:25:44,027 AND TO UNDERSTAND THAT THIS 4853 03:25:44,027 --> 03:25:45,528 MIGHT BE WORTHWHILE AND THAT 4854 03:25:45,528 --> 03:25:46,829 MIGHT BE A DIFFERENT EXPERIENCE 4855 03:25:46,829 --> 03:25:47,997 FROM SOMETHING THEY'VE TRIED IN 4856 03:25:47,997 --> 03:25:50,566 THE PAST. I THINK THOSE ARE TWO 4857 03:25:50,566 --> 03:25:51,534 ISSUES I DEFINITELY THINK THE 4858 03:25:51,534 --> 03:25:52,936 FIRST ONE IS A BIGGER ISSUE THAT 4859 03:25:52,936 --> 03:25:55,305 A MAJORITY OF THE PATIENTS ARE 4860 03:25:55,305 --> 03:25:56,172 MISDIAGNOSED AND WOULDN'T KNOW 4861 03:25:56,172 --> 03:25:57,240 WHEN THERE'S AN OPPORTUNITY TO 4862 03:25:57,240 --> 03:25:58,041 PARTICIPATE IN RESEARCH. 4863 03:25:58,041 --> 03:26:00,643 >> I WANT TO ADD ONTO THAT 4864 03:26:00,643 --> 03:26:03,079 BECAUSE THAT IS EXCELLENT POINTS 4865 03:26:03,079 --> 03:26:03,880 THAT YOU BROUGHT UP. WE 4866 03:26:03,880 --> 03:26:05,315 ACTUALLY SEE A LOT OF WOMEN COME 4867 03:26:05,315 --> 03:26:07,417 IN THROUGH THE CLINICS WHO HAD 4868 03:26:07,417 --> 03:26:10,086 NEVER EVEN HEARD ABOUT 4869 03:26:10,086 --> 03:26:11,955 ENDOMETRIOSIS BEFORE AND I THINK 4870 03:26:11,955 --> 03:26:14,123 THAT'S A REALLY BIG PROBLEM IS 4871 03:26:14,123 --> 03:26:15,625 THAT THERE'S STILL A LACK OF 4872 03:26:15,625 --> 03:26:18,394 AWARENESS. ABOUT THESE TYPES OF 4873 03:26:18,394 --> 03:26:19,429 CONDITIONS. INCLUDING 4874 03:26:19,429 --> 03:26:21,064 ENDOMETRIOSIS I CAN THINK BACK, 4875 03:26:21,064 --> 03:26:23,967 YOU KNOW, FIVE YEARS AGO. YOU 4876 03:26:23,967 --> 03:26:26,135 JUST REALLY DON'T HEAR ABOUT 4877 03:26:26,135 --> 03:26:29,439 THESE THINGS NOW YOU HEAR ABOUT 4878 03:26:29,439 --> 03:26:31,040 ENDOMETRIOSIS, ON COMMERCIALS, 4879 03:26:31,040 --> 03:26:34,243 AND SO I THINK THAT HAS BEEN 4880 03:26:34,243 --> 03:26:35,979 INCREASED AWARENESS BY WE STILL 4881 03:26:35,979 --> 03:26:37,981 HAVE A LOT OF ROOM TO GROW AND I 4882 03:26:37,981 --> 03:26:40,817 THINK IT'S JUST GOING TO REQUIRE 4883 03:26:40,817 --> 03:26:42,652 THAT WE KEEP TALKING ABOUT THESE 4884 03:26:42,652 --> 03:26:47,523 THINGS. WE KEEP DOING RESEARCH. 4885 03:26:47,523 --> 03:26:52,128 WE HELP -- WE WORK ON THIS FROM 4886 03:26:52,128 --> 03:26:54,797 A POLICY PERSPECTIVE AND REALLY 4887 03:26:54,797 --> 03:26:56,432 JUST TO TRY CREATE AWARENESS AND 4888 03:26:56,432 --> 03:26:57,600 KNOWLEDGE ABOUT THESE CONDITIONS 4889 03:26:57,600 --> 03:26:59,502 SO THAT OUR PATIENTS ARE AWARE 4890 03:26:59,502 --> 03:27:01,637 OF THEM. OUR MEDICAL PROVIDERS, 4891 03:27:01,637 --> 03:27:05,508 OUR RESEARCHERS ARE WARE AWARE 4892 03:27:05,508 --> 03:27:08,444 OF THEM SO WOMEN CAN BE HEARD. 4893 03:27:08,444 --> 03:27:09,779 ULTIMATELY WE NEED TO KEEP THE 4894 03:27:09,779 --> 03:27:10,713 CONVERSATION GOING. SO WE CAN 4895 03:27:10,713 --> 03:27:18,154 GAIN MORE MOMENTUM IN THE FIELD. 4896 03:27:18,154 --> 03:27:22,258 >> I THINK I WAS INCREDIBLY 4897 03:27:22,258 --> 03:27:26,662 MOVED BY KEENA'S DISCUSSION 4898 03:27:26,662 --> 03:27:28,464 TODAY ABOUT NOT JUST THE 4899 03:27:28,464 --> 03:27:29,565 EMOTIONAL COST AND THE PHYSICAL 4900 03:27:29,565 --> 03:27:32,769 COST OF CHRONIC PAIN BUT THE 4901 03:27:32,769 --> 03:27:35,671 ECONOMIC COSTS THAT THE DECISION 4902 03:27:35,671 --> 03:27:38,674 SHE HAS TO MAKE TO TRY TO GET 4903 03:27:38,674 --> 03:27:41,177 CARE TO SIGN ON CARE AND SINCE 4904 03:27:41,177 --> 03:27:46,749 THERE ARE NO APPROVED TREATMENTS 4905 03:27:46,749 --> 03:27:49,619 THAT MANY THIRD PARTY PROVIDERS 4906 03:27:49,619 --> 03:27:55,491 WILL NOT REIMBURSE OR PAY FOR 4907 03:27:55,491 --> 03:27:57,593 THESE TREATMENTS. ANY STRATEGY 4908 03:27:57,593 --> 03:27:59,162 THAT YOU HAVE FOUND AS PROVIDERS 4909 03:27:59,162 --> 03:28:00,730 WHO ARE TREATING PAIN DISORDERS 4910 03:28:00,730 --> 03:28:02,932 THAT MAY NOT HAVE ANY FDA 4911 03:28:02,932 --> 03:28:06,202 APPROVED TREATMENTS TO HELP 4912 03:28:06,202 --> 03:28:09,906 PATIENTS GET THE CARE, SOMEWHAT 4913 03:28:09,906 --> 03:28:13,409 AFFORDABLY GIVEN THE DIFFICULTY 4914 03:28:13,409 --> 03:28:16,579 SOMETIMES WITH THIRD PARTY 4915 03:28:16,579 --> 03:28:27,090 PAYERS? NO ANSWERS TO THAT. 4916 03:28:29,559 --> 03:28:30,927 ANY OTHER QUESTIONS THAT PEOPLE 4917 03:28:30,927 --> 03:28:33,396 WANT TO THROW OUT TO THE 4918 03:28:33,396 --> 03:28:35,965 CO-PANELISTS THAT MAYBE I 4919 03:28:35,965 --> 03:28:38,701 HAVEN'T ADDRESSED OR OUR 4920 03:28:38,701 --> 03:28:43,639 PARTICIPANTS HAVE NOT ADDRESSED? 4921 03:28:43,639 --> 03:28:45,608 I THINK OUR PANELISTS HAVE VERY 4922 03:28:45,608 --> 03:28:46,375 SHY TODAY. 4923 03:28:46,375 --> 03:28:48,377 >> I HAVE A QUESTION AND THAT IS 4924 03:28:48,377 --> 03:28:50,780 AFTER TODAY EITHER DOES -- DO SH 4925 03:28:50,780 --> 03:28:51,848 THIS IS SUSAN, DO PEOPLE THAT 4926 03:28:51,848 --> 03:28:55,885 ARE PREDOMINANTLY DEAL WITH 4927 03:28:55,885 --> 03:28:58,321 ENDOMETRIOSIS PATIENTS, HAVE -- 4928 03:28:58,321 --> 03:29:00,823 DID YOU LEARN ANYTHING DIFFERENT 4929 03:29:00,823 --> 03:29:03,626 ABOUT VULVODYNIA PATIENTS TODAY 4930 03:29:03,626 --> 03:29:05,895 OR -- DO PEOPLE WHO 4931 03:29:05,895 --> 03:29:06,429 PREDOMINANTLY DEAL WITH 4932 03:29:06,429 --> 03:29:08,798 VULVODYNIA PATIENTS DID YOU 4933 03:29:08,798 --> 03:29:11,434 LEARN ANYTHING DIFFERENT ABOUT 4934 03:29:11,434 --> 03:29:12,001 VULVODYNIA PATIENTS VERSUS 4935 03:29:12,001 --> 03:29:12,835 ENDOMETRIOSIS PATIENTS IN TERMS 4936 03:29:12,835 --> 03:29:15,671 OF HOW THEY COME TO THE TABLE 4937 03:29:15,671 --> 03:29:17,573 AND WHAT THEIR SPECIFIC NEEDS 4938 03:29:17,573 --> 03:29:19,375 ARE AND WHAT THEIR DESIRES ARE 4939 03:29:19,375 --> 03:29:22,945 FROM RESEARCH PROTOCOLS AND OR 4940 03:29:22,945 --> 03:29:23,813 TREATMENTS. ONE THING THAT 4941 03:29:23,813 --> 03:29:25,481 STICKS OUT TO ME I WILL START 4942 03:29:25,481 --> 03:29:30,019 BECAUSE I WORK PREDOMINANTLY 4943 03:29:30,019 --> 03:29:32,054 WITH VULVODYNIA BY BUT I ALSO 4944 03:29:32,054 --> 03:29:33,589 WORK WITH OTHER PATIENTS. 4945 03:29:33,589 --> 03:29:36,726 AND THERE'S MORE WITH ENDO 4946 03:29:36,726 --> 03:29:37,593 PATIENTS THAN THE VULVODYNIA. 4947 03:29:37,593 --> 03:29:41,964 IN TERMS OF OPIOID USE I SEE 4948 03:29:41,964 --> 03:29:44,167 MORE OF THAT IN THE ENDO IC 4949 03:29:44,167 --> 03:29:48,738 COMMUNITY AND VULVODYNIA 4950 03:29:48,738 --> 03:29:49,939 PATIENTS SHY AWAY FROM OPIOID 4951 03:29:49,939 --> 03:29:53,776 USE. THEY DON'T REALLY LIKE OIP 4952 03:29:53,776 --> 03:29:54,377 EYED USE AND REALLY RUN FROM 4953 03:29:54,377 --> 03:29:57,980 THAT AND RUN THAT FROM THAT AS 4954 03:29:57,980 --> 03:29:58,281 AN ANSWER. 4955 03:29:58,281 --> 03:30:05,188 THEY ARE MORE I GUESS AMENABLE 4956 03:30:05,188 --> 03:30:07,857 TO BENZOS OR DIAZEPAM 4957 03:30:07,857 --> 03:30:09,392 SUPPOSITORIES BUT NOT REALLY 4958 03:30:09,392 --> 03:30:10,726 OPIOIDS THAT'S AN INTERESTING 4959 03:30:10,726 --> 03:30:13,329 DISTINCTION FOR ME AT LEAST BY A 4960 03:30:13,329 --> 03:30:14,463 UNIFYING PORTION BETWEEN BOTH 4961 03:30:14,463 --> 03:30:17,300 CADRES OF PATIENTS IS THAT IF 4962 03:30:17,300 --> 03:30:22,905 ANYTHING IN THE CBD/THC SPACE 4963 03:30:22,905 --> 03:30:23,940 COULD WORK FOR THEM THEY WOULD 4964 03:30:23,940 --> 03:30:31,147 BE VERY, VERY EXCITED ABOUT 4965 03:30:31,147 --> 03:30:41,157 THAT. THOUGHTS? 4966 03:30:41,157 --> 03:30:42,658 >> I DO BELIEVE THAT RESEARCH 4967 03:30:42,658 --> 03:30:47,964 WOULD BE WARRANTED IN THE 4968 03:30:47,964 --> 03:30:49,665 THC/CBD SPACE. IT IS--IT HAS 4969 03:30:49,665 --> 03:30:51,834 BEEN SLIGHTLY DIFFICULT TO GET 4970 03:30:51,834 --> 03:30:55,471 WELL, I DID TRY TO DO AN IND FOR 4971 03:30:55,471 --> 03:30:59,675 A CBD SUPPOSITORY FOR PELVIC 4972 03:30:59,675 --> 03:31:02,345 PAIN. BUT THAT REQUIRED MUCH 4973 03:31:02,345 --> 03:31:05,381 PRECLINICAL WORK THAT, 4974 03:31:05,381 --> 03:31:07,650 UNFORTUNATELY, WOULD BE VERY 4975 03:31:07,650 --> 03:31:09,552 COSTLY AND DOESN'T SEEM TO BE 4976 03:31:09,552 --> 03:31:11,254 ANY -- COMPANIES ARE WILLING TO 4977 03:31:11,254 --> 03:31:13,122 DO THE PRECLINICAL WORK GIVEN 4978 03:31:13,122 --> 03:31:15,758 THAT IT'D BE DIFFICULT TO PATENT 4979 03:31:15,758 --> 03:31:19,962 SUCH A PRODUCT OR THAT OTHER -- 4980 03:31:19,962 --> 03:31:23,132 BECAUSE CBD AND THC IS SO NOW 4981 03:31:23,132 --> 03:31:24,333 WIDELY AVAILABLE THERE'D BE NO 4982 03:31:24,333 --> 03:31:28,004 RETURN ON INVESTMENT EVEN IF 4983 03:31:28,004 --> 03:31:32,108 THERE WAS PROVEN IN A CLINICAL 4984 03:31:32,108 --> 03:31:35,478 TRIAL FOR -- TO MOVE FORWARD IN 4985 03:31:35,478 --> 03:31:38,381 A, YOU KNOW, TO GET FDA 4986 03:31:38,381 --> 03:31:42,385 APPROVAL. SO I DID HAVE AN IND 4987 03:31:42,385 --> 03:31:48,291 SUBMISSION THAT I HAD TO 4988 03:31:48,291 --> 03:31:50,192 WITHDRAW BECAUSE OF THE 4989 03:31:50,192 --> 03:31:51,294 REQUIREMENTS OF SO MUCH 4990 03:31:51,294 --> 03:31:53,763 PRECLINICAL WORK THAT THE FDA 4991 03:31:53,763 --> 03:31:57,767 WANTED AND THAT WAS DISCUSSED IN 4992 03:31:57,767 --> 03:31:58,367 THE DRAFT GUIDANCE. 4993 03:31:58,367 --> 03:32:01,570 >> THAT'S A GOOD POINT. THANK 4994 03:32:01,570 --> 03:32:05,608 YOU 4995 03:32:05,608 --> 03:32:05,775 YOU. 4996 03:32:05,775 --> 03:32:07,943 >> I WILL SAY THAT YOU RAISE AN 4997 03:32:07,943 --> 03:32:09,378 INTERESTING TOPIC. I THINK EVEN 4998 03:32:09,378 --> 03:32:14,183 IF YOU'RE NOT FOCUSED ON 4999 03:32:14,183 --> 03:32:18,788 STUDYING A CBD OR THC PRODUCT 5000 03:32:18,788 --> 03:32:21,223 YOU MIGHT CONSIDER COLLECTING 5001 03:32:21,223 --> 03:32:22,758 DATA ON CANNABIS USE 5002 03:32:22,758 --> 03:32:24,393 PARTICULARLY IN YOUNGER 5003 03:32:24,393 --> 03:32:26,862 POPULATION OF FOLKS WHO ARE 5004 03:32:26,862 --> 03:32:30,333 LIKELY TO SELF-MEDICATE WITH 5005 03:32:30,333 --> 03:32:33,402 CANNABIS. NOT TO RULE IT OUT OR 5006 03:32:33,402 --> 03:32:37,740 MAKE AN EXCLUSION CRITERIA BUT 5007 03:32:37,740 --> 03:32:39,642 TO FACTOR IT IN WHEN IT COMES TO 5008 03:32:39,642 --> 03:32:40,810 DETERMINING WHETHER OR NOT YOUR 5009 03:32:40,810 --> 03:32:42,244 PRODUCT IS MORE EFFECTIVE THAN 5010 03:32:42,244 --> 03:32:46,782 PLACEBO IF THERE IS A HUGE 5011 03:32:46,782 --> 03:32:48,484 IMBALANCE IN THE CANNABIS USE 5012 03:32:48,484 --> 03:32:50,219 THAT CAN BE TELLING. IT'S VERY 5013 03:32:50,219 --> 03:32:53,122 SIMILAR TO HOW WE APPROACH IN 5014 03:32:53,122 --> 03:32:56,625 THE AREA OF RESCUE MEDICATION. 5015 03:32:56,625 --> 03:33:00,863 SO IF YOUR DRUG IS WORKING WELL 5016 03:33:00,863 --> 03:33:04,200 COMPARED TO PLACEBO, THAT MAY BE 5017 03:33:04,200 --> 03:33:06,302 CONFOUNDED BY THE NEED TO 5018 03:33:06,302 --> 03:33:09,138 INCREASE RESCUE MEDICATION. SO 5019 03:33:09,138 --> 03:33:12,108 JUST THE MORE DATA YOU CAN 5020 03:33:12,108 --> 03:33:18,381 COLLECT TO BRING TO BARE ON WHAT 5021 03:33:18,381 --> 03:33:19,715 HAPPENING WITH THESE MEDICATIONS 5022 03:33:19,715 --> 03:33:21,150 THE BETTER YOU'LL BE. 5023 03:33:21,150 --> 03:33:23,219 >> IT'S INTERESTING YOU BRING UP 5024 03:33:23,219 --> 03:33:26,222 THC AND CBD, ONE OF THE SIDE 5025 03:33:26,222 --> 03:33:27,390 CONVERSATIONS AT THE HEAL EVENT 5026 03:33:27,390 --> 03:33:31,494 A COUPLE MONTHS AGO THERE WAS A 5027 03:33:31,494 --> 03:33:34,864 DISCUSSION OF SILL LA SAY BIN. 5028 03:33:34,864 --> 03:33:36,665 AGAIN THAT'S ANOTHER MOON SHOT 5029 03:33:36,665 --> 03:33:38,968 BUT HAS ANYBODY TALKED ABOUT 5030 03:33:38,968 --> 03:33:41,303 THAT THE USE OF SILL LA SAY BIN. 5031 03:33:41,303 --> 03:33:42,471 IS THAT RIGHT, SUSAN? 5032 03:33:42,471 --> 03:33:52,615 >> YEP. 5033 03:33:55,351 --> 03:33:56,485 >> THE END RESULT IS ALWAYS 5034 03:33:56,485 --> 03:33:58,587 THESE CONVERSATIONS WE NEED TO 5035 03:33:58,587 --> 03:34:00,089 CONTINUE TO DO WELL-DESIGNED 5036 03:34:00,089 --> 03:34:01,624 CLINICAL TRIALS TO TRY TO 5037 03:34:01,624 --> 03:34:03,559 ACCOUNT FOR AS MANY VARIABLES AS 5038 03:34:03,559 --> 03:34:08,798 POSSIBLE IN A VERY HETEROGENOUS 5039 03:34:08,798 --> 03:34:10,399 POPULATION OF GYNECOLOGIC PAIN 5040 03:34:10,399 --> 03:34:12,301 PATIENTS BUT THAT WE DO NEED TO 5041 03:34:12,301 --> 03:34:15,838 KEEP MOVING FORWARD TO HELP THE 5042 03:34:15,838 --> 03:34:17,706 MANY MILLIONS OF WOMEN WHO ARE 5043 03:34:17,706 --> 03:34:19,642 SUFFERING FOR TIME OF PAIN WE 5044 03:34:19,642 --> 03:34:20,443 SPENT THE LAST FOUR AND A HALF 5045 03:34:20,443 --> 03:34:24,513 HOURS TALKING ABOUT TODAY. 5046 03:34:24,513 --> 03:34:27,683 >> THANK YOU VERY MUCH, 5047 03:34:27,683 --> 03:34:30,419 DR. GOLDSTEIN. AND ALL THE 5048 03:34:30,419 --> 03:34:36,392 SPEAKERS. AND THANK YOU. I 5049 03:34:36,392 --> 03:34:37,293 REALLY APPRECIATE YOU STAYED 5050 03:34:37,293 --> 03:34:39,595 WITH US UNTIL THE END OF THE 5051 03:34:39,595 --> 03:34:40,863 MEETING. I AM SO GRATEFUL FOR 5052 03:34:40,863 --> 03:34:44,366 ALL THE SPEAKERS WHO GAVE THE 5053 03:34:44,366 --> 03:34:45,835 WONDERFUL TALKS. IT WAS MY 5054 03:34:45,835 --> 03:34:49,338 GREAT PLEASURE TO MEET YOU ALL 5055 03:34:49,338 --> 03:34:52,107 AND LEARN MORE ABOUT GYNECOLOGIC 5056 03:34:52,107 --> 03:34:55,544 PAIN RESEARCH AND THE RECORDING 5057 03:34:55,544 --> 03:34:58,581 WITH SPEAKER'S APPROVAL WILL BE 5058 03:34:58,581 --> 03:34:59,782 POSTED ON THE WEB PAGE AFTER 5059 03:34:59,782 --> 03:35:02,117 THIS MEETING. IF YOU WOULD LIKE 5060 03:35:02,117 --> 03:35:04,854 TO SHARE YOUR RESEARCH FINDINGS 5061 03:35:04,854 --> 03:35:08,290 AT OUR NEXT MEETING IN 2025 5062 03:35:08,290 --> 03:35:10,459 PLEASE E-MAIL ME AND IF YOU HAVE 5063 03:35:10,459 --> 03:35:13,896 ANY OTHER QUESTIONS OR FEEDBACK, 5064 03:35:13,896 --> 03:35:16,365 PLEASE FEEL FREE TO CONTACT US 5065 03:35:16,365 --> 03:35:17,433 ANYTIME AND THANK YOU VERY MUCH 5066 03:35:17,433 --> 03:35:20,035 FOR JOINING US TODAY AND HAVE A 5067 03:35:20,035 --> 03:35:22,304 GOOD NIGHT AND BYE, EVERYONE. 5068 03:35:22,304 --> 03:35:24,473 >> THANK YOU, HELENA. 5069 03:35:24,473 --> 03:35:25,508 >> THANK YOU SO MUCH. 5070 03:35:25,508 --> 03:35:27,576 >> THANKS, HELENA, BYE, 5071 03:35:27,576 --> 03:35:27,977 EVERYONE. 5072 03:35:27,977 --> 03:35:38,320 >> THANK YOU. BYE.