I WOULD LIKE TO CALL THE 105th MEETING OF THE NATIONAL ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES ADVISORY COUNCIL TO ORDER. THANK YOU ALL FOR JOINING US TODAY. COUNCIL MEETINGS ARE OPEN TO THE PUBLIC AS REQUIRED BY LAW EXCEPT FOR THE REVIEW, DISCUSSION AND EVALUATION OF GRANT APPLICATIONS AND RELATED INFORMATION WHICH WE WILL DO IN CLOSED SESSION THIS AFTERNOON. FOR THOSE MEMBERS OF THE PUBLIC WATCHING VIA VIDEOCAST, WE INVITE YOU TO SUBMIT YOUR COMMENTS VIA THE COMMENT BUTTON ON THE WEB PAGE. BEFORE WE PROCEED WITH THE BUSINESS OF THE MEETING THOUGH, MS. MELINDA NELSON WILL GO OVER LOGISTICS AN CONSIDERATIONS INTEREST THE LAST COUNCIL MEETING AND FUTURE COUNCIL DATES. THANKS, MELINDA. >> GOOD MORNING AND WELCOME TO EVERYONE. THIS IS OUR FIFTH VIRTUAL COUNCIL MEETING WITH OUR MEMBERS AND STAFF ON THE ZOOM CALL THIS MORNING AND THE REST OF THE STAFF AND THE PUBLIC WATCHING VIA THE LIVE VIDEOCAST. IF ANY STAFF MEMBER WATCHING THE VIDEOCAST HAS AN URGENT COMMENT OR QUESTION, PLEASE E-MAIL LIZ BORIS AND SHE WILL REFER THE QUESTION TO ME. WE ENCOURAGE VIEWERS TO SUBMIT WRITTEN COMMENTS EITHER IN REAL TIME USING THE LINK ON THE VIDEOCAST SCREEN CALLED LIVE EVENT FEEDBACK OR IN WRITING UP TO 15 DAYS FOLLOWING THE MEETING. ON THE ZOOM CALL YOU MAY SPEAK BUT BE SURE TO MUTE WHEN NOT SPEAKING AND YOU CAN RAISE YOUR HAND AN WE'LL CALL ON YOU AND WE'LL HAVE HELP WITH THE MUTING AND UNMUTING ESPECIALLY WHEN TAKING VOTES. IF COUNCIL MEMBERS NEED COMPUTER SUPPORT DURING THE MEETING PLEASE E-MAIL LIZ BORIS. I WOULD ALSO LIKE TO REMIND YOU ABOUT INCOMING CONFLICT OF INTEREST REPORTING DATES TO UPDATE THE REQUEST OF THE COUNCIL MEMBERS IN OCTOBER, FEBRUARY AND IN JUNE. WHEN YOU RECEIVE THOSE REQUESTS YOU MUST RESPOND WITHIN 30 DAYS TO PARTICIPATE IN COUNCIL-RELATED ACTIVITIES. LET ME TURN TO THE CONSIDERATION OF THE MINUTES. WE'RE GOING TO TAKE A VOTE SO CAN THE COUNCIL MEMBERS PLEASE MAKE SURE THAT YOU ARE UNMUTED. YOU'VE SEEN THE MINUTES OF THE MAY 18, 2020 COUNCIL MEETING POSTED IN THE ELECTRONIC COUNCIL BOOK. DOES ANYONE HAVE ANY COMMENTS OR CORRECTIONS? HEARING NONE, MAY I HAVE A MOTION TO APPROVE THE MAY 18 COUNCIL MINUTES? >> MOTION TO APPROVE. >> SECOND. >> THANK YOU. ALL IN FAVOR SAY AYE. OPPOSED? THE MOTION PASSES. THANK YOU. I WOULD ALSO LIKE TO REMIND YOU OF THE DATES OF THE FUTURE COUNCIL MEETINGS AND THEY'RE POSTED IN THE ECB. THE NEXT MEETING IS FEBRUARY 21, 2022 AND IT WILL ALSO BE VIRTUAL. WE APPRECIATE YOUR PARTICIPATION SO PLEASE MAKE SURE THESE DATES ARE ON YOUR CALENDAR. NOW I'LL TURN IT BACK TO DR. CRISWELL. >> THANKS, MELINDA. AS YOU HEARD, OUR FEBRUARY 1 MEETING WILL BE VIRTUAL AND AS MUCH AS WITH WE WOULD LIKE IT SEE EACH OF YOU IN PERSON, WE'RE CONTINUING TO FOCUS PRIMARILY ON SAFETY SO THANK YOU SO MUCH FOR YOUR UNDERSTANDING AND PATIENCE. WELCOME AGAIN TO THIS VIRTUAL MEETING. THIS WAS SUPPOSED TO BE THE LAST COUNCIL MEETING FOR THESE MEMBERS BUT WE INVITED THEM TO STAY ON THROUGH EXTENSION. WE RECOGNIZE THIS IS A CONSIDERABLE TIME COMMITMENT AND DELIGHTED ALL HAVE AGREED TO EXTEND THEIR TERMS THROUGH MARCH 22. I'M DEEPLY APPRECIATIVE FOR THEIR WILLINGNESS TO CONTINUE TO SUPPORT US. WE HAVE CERTIFICATES ACKNOWLEDGING THEIR SERVICE WITH WHICH WE'LL SEND IN THE MAIL SO THANK YOU AGAIN FOR YOUR ONGOING SERVICE. WE SHOULD HAVE A NEW SLATE OF COUNCIL MEMBERS IN FEBRUARY. I LOOK FORWARD TO INTRODUCING THEM AT THAT MEETING. MY REMARKS ARE DIVIDED INTO THE BUDGET, PERSONNEL CHANGES AND NIH AND NIAMS ACTIVITIES. SO THE NEXT SLIDE STARTING WITH THE BUDGET, THIS SLIDE DEPICTS THE CURRENT VERSION OF OUR FUNDING PLAN WITH MOST SET AT THE 20 PERCENTILE. YOU CAN ALSO SEE RO1 APPLICATIONS WILL BE PAID THROUGH THE 16th PERCENTILE. THESE PERCENTAGES HAVE IMPROVED FROM EARLIER IN THE YEAR. I'M DELIGHTED TO SAY AND PLEASED BE ASSURED THAT NIAMS LEADERSHIP CONTINUES TO WORK CLOSELY WITH OUR BUDGET OFFICE TO REFER CREATIVE WAYS TO IMPROVE CREATIVE WAYS TO PAY INVESTIGATOR INITIATED GRANTS AND BALANCING THE NEEDS FOR PROJECTS OUTSIDE THE RO1 MECHANISM. NOW, IF YOU TURN TO THE NEXT SLIDE, WHILE THE PRESIDENT AND HOUSE OF REPRESENTATIVES PROPOSED A FISCAL YEAR 2022 BUDGET FOR NIH AND NIAMS WE EXPECT THE SENATE PROPOSAL WILL NOT BE READY IN TIME FOR BOTH CHAMBERS TO REACH AGREEMENT ON THE BILL AND FOR THE PRESIDENT TO SIGN IT BEFORE NIH'S FISCAL YEAR BEGINS OCTOBER 1. THEREFORE, WE EXPECT TO BEGIN FISCAL YEAR 2022 WITH A CONTINUING RESOLUTION. NOW, THIS USUALLY MEANS NIH CAN CONTINUE TO OPERATE AT OR SLIGHTLY BELOW ITS CURRENT BUDGET UNTIL LEGISLATION PROVIDING FOR A FULL BUDGET CAN BE ENACTED. NOW, LOOKING AT THE PRESIDENT'S BUDGET AND THAT OF THE HOUSE OF REPRESENTATIVES, THE NEWS LOOKS QUITE PROMISING FOR NIH AND NIAMS. BOTH PROPOSED BUDGETS INCLUDE AN INCREASE FOR HEAL WHICH STANDS FOR HELPING TO END ADDICTION LONG TERM AND THOSE OF YOU FAMILIAR WITH THE BACPAC PROGRAM KNOW IT'S BEEN FUNDED THROUGH HEAL BUT THEY ALSO INCLUDE AN ADDITIONAL $24 MILLION TO ENHANCE NIAMS' PAIN AND RESEARCH PORTFOLIO AND WE'RE DEVELOPING PLANS TO BEST INVEST THIS MONEY SHOULD IT BE INCLUDED IN THE FINAL BILL. NOW, LATER TODAY WE WILL BE PRESENTING A COUPLE CONSENTS RELATED TO PAIN IN ANTICIPATION OF FUNDING THROUGH HEAL OR DIRECTLY TO NIAMS. WE'RE EXCITED AND GRATEFUL FOR THIS POTENTIAL SUPPORT AS PAIN IS AN IMPORTANT DEBILITATING COMPONENT OF MANY DISEASES WITHIN OUR PORTFOLIO AS YOU ARE ALL VERY WELL AWARE. NOW, THE PRESIDENT'S AND HOUSE BUDGETS INCLUDE FUNDING FOR A NEW NIH COMPONENT YOU MAY HAVE HEARD OF CALLED ARPA-H. I'M DRAWING YOUR ATTENTION TO THIS COMMUNICATION THAT CAME OUT RELATED TO THAT PROGRAM SO ARPA-H WHICH STANDS FOR ADVANCED RESEARCH PROJECTS AGENCY AND THE H, WHY STANDS FOR HEALTH IS THE DEFENSE'S PROJECT AGENCY THE CENTER RESEARCH AND DEVELOPMENT AGENCY FOR THE DEPARTMENT OF DEFENSE. SO ARPA-H WILL USE A DARPA AS A MODEL TO ESTABLISH THE CULTURE OF CHAMPIONING INNOVATIVE IDEAS IN HEALTH AND MEDICINE. FOR EXAMPLE, BY FOCUSSING ON MULTIPLE TIME LIMITED PROJECTS WITH DIFFERENT APPROACHES TO ACHIEVE A QUANTIFIABLE GOAL, THE LINE ON DEFINED METRICS AND INJECTING ACCOUNTABILITY THROUGH MEETING THESE METRICS AND SUPPORTING USE-DRIVEN IDEAS FOCUSSED ON SOLVING PRACTICAL PROBLEMS THAT ADVANCE EQUITY AND RAPIDLY TRANSFORM BREAKTHROUGHS INTO TANGIBLE SOLUTIONS. THIS SUMMER THE NIH AND WHITE HOUSE HELD A SERIES OF LISTENING SESSION TO GET FEEDBACK FROM PATIENT ADVOCACY GROUPS, INDUSTRY, SCIENTIFIC PROFESSIONAL ORGANIZATIONS AND OTHER STAKEHOLDERS. I AM SERVING ON THE TRANS NIH ARPA-H TASK FORCE AND I WANT TO THANK THE AMERICAN COLLEGE OF RHEUMATOLOGY AND SOCIETY FOR MINERAL RESEARCH AND INVESTIGATIVE DERMATOLOGY FOR MAKING SURE NIAMS RESEARCH COMMUNITY INTERESTS WERE REPRESENTED. I'M SURE IT'S A GREAT TOPIC OF INTEREST AND KEEP YOU UPDATED AS PLANS UNFOLD. NOW, I WANT TO HIGHLIGHT A FEW NIH PERSONNEL CHANGES. AFTER NEARLY THREE DECADES OF SERVICE AS THE NIH DEPUTY DIRECTOR FOR INTRAMURAL RESEARCH DR. GOTTESMAN IS STEPPING DOWN. THE DEPUTY DIRECTOR COORDINATES ACTIVITIES AN COOPERATION AMONG THE 24 INSTITUTES AND CENTERS THAT PARTICIPATE IN THE NIH INTRAMURAL PROGRAM AND THIS PERSON OVERSEES AND APPROVES THE HIRING OF ALL PRINCIPLE INVESTIGATORS AND IS THE INSTITUTIONAL OFFICIAL RESPONSIBLE FOR HUMAN SUBJECTS RESEARCH PROTECTIONS, RESEARCH INTEGRITY, TECHNOLOGY TRANSFER AND ANIMAL CARE AND USE AT THE NIH. SO A REALLY IMPORTANT POSITION AND A NATIONAL SEARCH IS ONGOING TO FILL THIS POSITION. ON THE NEXT SLIDE, AT THE END OF MAY, NIH DIRECTOR DR. FRANCIS COLLINS APPOINTED DR. BERNARD AS CHIEF OFFICER FOR SCIENTIFIC WORKFORCE DIVERSITY. DR. BERNARD HAD BEEN THE ACTING CHIEF OFFICER FOR WORKFORCE DIVERSITY SINCE OCTOBER 2020 CHAMPIONING DIVERSITY AND INCLUSION EFFORTS INCLUDING SERVING A ROLE IN EFFORTS TO END STRUCTURAL RACISM IN BIOMEDICAL RESEARCH THROUGH THE UNITE INITIATIVE I TOLD YOU ABOUT IN MAY. SHE'S A FOUNDING MEMBER OF THE NIH EQUITY COMMITTEE, CO-CHAIR OF THE NIH INCLUSION AND GOVERNANCE COMMUNITY WHICH OVERSEES INCLUSION IN CLINICAL RESEARCH BY SEX AND GENDER, RACE AND ETHNICITY AND AGE. SO ON THE NEXT SLIDE, I WANT TO HIGHLIGHT A COUPLE NIH AND NIAMS ACTIVITIES TO MAKE YOU AWARE OF. SO MANY OF THE DISEASES AND CONDITIONS WITHIN THE NIAMS MISSION DISPROPORTIONATELY AFFECT WOMEN AND MINORITIES. I RECENTLY MET WITH DR. JANINE CLAYTON DIRECTOR OF THE NIH OFFICE OF RESEARCH ON WOMEN'S HEALTH TO DISCUSS TOPICS WITHIN OUR ORGANIZATION'S MISSIONS. THE OFFICE OF RESEARCH ON WOMEN'S HEALTH IN CONJUNCTION WITH ADVISORY COUNCIL IS SEEKING INPUT ON GAPS IN RESEARCH AND TOPICS AND INCLUDING THE RATES OF CHRONIC DEBILITATING CONDITIONS ON WOMEN. COMMENTS WILL INFORM THE OCTOBER 2021 CONFERENCE ON ADVANCING NIH RESEARCH ON THE HEALTH OF WOMEN. I ENCOURAGE YOU TO RESPOND TO THE REQUEST FOR COMMENTS AND REGISTER FOR THE CONFERENCE IF YOU'RE INTERESTED USING THE LINK SHOWN ON THE SLIDE. SO ON THE NEXT SLIDE, I WANTED TO LET YOU KNOW NIH ALSO IS REQUESTING INPUT ON SAMPLE CONSENT LANGUAGE FOR FUTURE USE OF DATA AND BIO SPECIMENS. PATIENT PARTICIPATION IS THE CORNERSTONE OF CLINICAL RESEARCH AND RESPONSIBLE SHARING OF DATA AND SPECIMENS DERIVED FROM HUMAN PARTICIPANTS REALIZE ON ROBUST INFORMED CONSENT PRACTICES THE NIH HEARD FROM STAKEHOLDERS BUT THERE'S A STRONG INTEREST IN ESTABLISHING A SET OF BEST PRACTICES FOR DEVELOPING INFORMED CONSENT LANGUAGE REGARDING DATA AROUND BIOSPECIMEN SHARING. THEREFORE THE NIH HAS WORKED TO DEVELOP SAMPLE LANGUAGE THAT MAY BE USED IN INFORMED CONSENT WHEN DATA AND BIOSPECIMEN SHARING MAY OCCUR AS WELL AS POINTS TO CONSIDER INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS WHEN USING OR MODIFYING THE LANGUAGE. THESE ARE INTENDED TO SERVE AS A RESOURCE FOR INVESTIGATORS FROM WHICH THEY CAN TAILOR APPROPRIATE INFORMED CONSENT LANGUAGE TO THEIR SPECIFIC STUDY NEEDS AND USE THE SAMPLE INFORMED CONSENT LANGUAGE WILL BE COMPLETELY VOLUNTARY. BUT THE NIH WELCOMES INPUT FROM INSTITUTIONAL REVIEW BOARD MEMBERS AND PARTICIPANTS AND ORGANIZATIONS AND THOSE WITH AN EMPHASIS ON RESEARCH OVERSIGHT AND OTHER INTERESTED MEMBERS OF THE PUBLIC AND THE LANGUAGE MAY BE UPDATED THE REQUEST FOR INFORMATION IS CONSIDERED. NOTE THE RESPONSES MAY BE SUBMITTED BY ENDS OF DAY SEPTEMBER 29 USING THE LINK SHOWN ON THE SLIDE. SO OUR NEXT SLIDE WITH THE RAPIDLY CHANGING SCIENTIFIC LANDSCAPE REGARDING THE COVID-19 PANDEMIC I WANT TO MAKE SURE YOU AND ANY PATIENTS OR MEMBERS OF THE PUBLIC LISTENING TO THIS MEETING BY VIDEOCAST ARE AWARE OF THE LATEST RECOMMENDATIONED REGARDING COVID-19 VAX AND BOOSTER SHOTS. THE CDC IS RECOMMENDING MODERATELY TO IMMUNOCOMPROMISED PEOPLE RECEIVE AN ADDITIONAL DOSE INCLUDING THOSE BEING TREATED WITH MEDICINES THAT SUPPRESS THE IMMUNE RESPONSE AND PATIENTS SHOULD TALK TO THEIR HEALTH CARE PROVIDER ABOUT THEIR CONDITION AND WHETHER GETTING AN ADDITIONAL DOSE IS APPROPRIATE FOR THEM. I WANTED TO LET YOU KNOW ABOUT AN UPCOMING COMPONENT AND INFLAMMATION IS A TOPIC AND WE'LL HAVE A ROUNDTABLE TO TALK ABOUT THE INTRINSIC MECHANISM AND HOW IT MAY CONTRIBUTE TO THE RESOLUTION AREAS. THE RESOLUTION OF INFLAMMATION IS KNOWN TO BE A COMPLEX AND COORDINATED PROCESS THAT DAMPENS INFLAMMATION AND STIMULATES TISSUE REPAIR AND REGENERATION. UNCONTROLLED AND DYSFUNCTIONAL RESOLUTION DEFAMATION MAY LINK TO CHRONIC INFLAMMATION. TWO DOCTORS HAVE AGREED TO SERVE AS CO-CHAIRS FOR THIS ROUNDTABLE. WE'VE INVITED ABOUT 20 PEOPLE FROM THE EXTRAMURAL AND PATIENT COMMUNITIES AND THEY SPAN VARIOUS TOPICS ACROSS THE INSTITUTE. THIS SLIDE LISTS SOME OF THE POTENTIAL TOPICS FOR DISCUSSION. YOU'RE WELCOME TO WATCH THE VIDEOCAST AT VIDEOCAST.NIH.gov AND IT WILL BE ARCHIVED FOR FUTURE VIEWING. OUR HOPE IS IT THIS ROUNDTABLE WILL HELP INFORM THE NIAMS COMMUNITY WITH THE ROLE OF INFLAMMATION RESOLUTION IN DISEASE PATHOGENESIS AND ULTIMATELY IMPROVE THE WAYS TO TREAT CHRONIC INFLAMMATORY DISEASES AND CONDITIONS. BEFORE I REVIEW THE AGENDA I WANT TO CALL YOUR ATTENTION TO THE HANDFUL OF SCIENCE HANESES IN THE ELECTRONIC COUNCIL BOOK. STAFF DEVELOPING SCIENCE CONVENIENCES DURING THE CONGRESSIONAL APPROPRIATION PROCESS AND FOR OTHER PURPOSE AND THOSE SYNCHRONIZE WITH COUNCILS AND YOU'LL SEE THERE ARE FEWER ADVANCES IN YOUR COUNCIL BOOK COMPARED TO THE PREVIOUS ROUNDS BUT I ASSURE YOU THAT OUR STAFF ARE BUSY TO WRITING UP THE MANY IMPORTANT ADVANCES FROM OUR INVESTIGATORS. I WANTED TO GO OVER THE AGENDA BRIEFLY. WE DESIGNED THIS TO LEAVE PLENTY OF TIME FOR DISCUSSION FOR EACH OF THE TOPICS. SO FIRST, YOU'LL HEAR FROM DEPUTY DIRECTOR ROBERT CARTER ON THE NEXT STEPS FOR THE ACCELERATING MEDICINES PARTNERSHIP AND NEW WORKING GROUP OF COUNCIL WE'RE ESTABLISHING. THEN ALONG WITH DR. SUSAN NA SERRATE-SZTEIN WE'LL TELL YOU ABOUT ANOTHER WORKING GROUP OF COUNCIL. THIS ONE ON HOW THE INSTITUTE OVERSEES DATA SCIENCE. NOW, BECAUSE COUNCIL WORKING GROUPS PROVIDE FINDINGS AND RECOMMENDATIONS TO THE COUNCIL, NOT TO THE INSTITUTE, WE LOOK FORWARD TO GETTING YOUR THOUGHTS ON HOW TO FOCUS THIS GROUP IN ORDER TO BEST ADVICE YOU AS WE GO FORWARD. AFTER THE BREAK, DR. GAYLE LESTER WILL TALK ABOUT THE INSTITUTE'S POLICY FOR ACCEPTING APPLICATIO APPLICATIONS WITH BUDGETS OF $150,000 IN ANY GIVEN YEAR OR MORE AND AT THE END OF THE SESSION GAYLE WILL PRESENT IDEAS FOR CONSENT CLEARANCE. SO NOW THAT I'VE REACHED THE END OF MY PREPARED REMARK I'D LIKE TO BUILD UPON SOME OF THE TOPICS WE ADDRESSED DURING MY FIRST COUNCIL MEETING AND MY SUBSEQUENT ONE-ON-ONE CONVERSATIONS WITH EACH OF YOU. ONE OF THOSE TOPICS RELATES TO STRATEGIES TO MAKE THE COUNCIL AS EFFECTIVE AS POSSIBLE IN ADVISING NIAMS LEADERSHIP. MANY OF YOU ALSO EXPRESSED SUPPORT FOR MY PROPOSAL TO HAVE JUNIOR RESEARCHERS AND POSSIBLY ALSO SUBJECT MATTER EXPERTS SERVE AS AD HOC MEMBERS OF THE COUNCIL. NOW, WE'LL NOT DISCUSS OPEN NAMES IN OPEN SESSION WE WELCOME ADDITIONAL THOUGHTS YOU HAVE ABOUT THIS I'D AND SEPARATELY WELCOME SUGGESTIONS FOR AD HOC MEMBERS AND RAISE OTHER TOPICS YOU THINK WOULD BENEFIT FROM A GROUP DISCUSSION AT THIS TIME. SO ON THAT NOTE, I'D LIKE TO OPEN THE FLOOR FOR DISCUSSION AND PERHAPS NEIL, MAYBE YOU CAN CHANGE THE VIEW SO WE HAVE THE GALLERY VIEW. >> IF YOU'D LIKE TO SPEAK UP, UNMUTE YOUR MICROPHONE AND WE'D BE INTERESTED TO HEAR COMMENTS OR QUESTIONS AT THIS TIME. >> I THINK IT'S A WONDERFUL IDEA TO HAVE AD HOC MEMBERS TO INTRODUCE JUNIOR MEMBERS TO THE WORK AND I THINK IT'S A WONDERFUL IDEA. >> GREAT, THANK YOU. I THINK ALL OF YOU EXPRESSED SUPPORT FOR THAT IDEA. I'M EXCITED ABOUT THE OPPORTUNITY AND LOOK FORWARD TO SUBSEQUENTLY HEARING SOME SUGGESTED NOMINATIONS FOR SUCH MEMBERS. THANK YOU. >> SO I REALLY ENJOYED THE OPPORTUNITY IN PART BECAUSE I'M NEW TO THE INSTITUTE TO MEET WITH EACH OF YOU ON A ZOOM CALL IN THE LAST COUPLE MONTHS AND APPRECIATED ALL YOUR SUGGESTIONS. I TOOK SOME NOTES DURING THOSE CONVERSATIONS BUT IF THERE'S TOPICS THAT CAME UP YOU'D LIKE TO SHARE FROM THE GROUP TO BENEFIT FROM A GROUP SUGGESTION, PLEASE FEEL FREE TO DO SO AT THIS TIME. >> LYNN >> LINDSEY, SO WE KNOW WHO SUGGEST, ARE YOU TALKING ABOUT K LEVEL FOLKS OR EARLY RO1? >> I THINK K AWARDEE SOUNDS LIKE A GOOD GROUP. I THINK IF THERE WAS SOMEONE A LITTLE BIT YOUNGER YOU THINK CAN CONTRIBUTE IMPORTANTLY AND ANOTHER THING TO KEEP IN MIND WHERE WE HAVE GAPS IN TERMS OF SPECIFIC BACKGROUNDS AND MAY HELP COMPLEMENT THE EXPERTISE WE HAVE FOR THE REGULAR COUNCIL MEMBERS. AND PART OF THE IDEA BEHIND THIS WAS I THINK FOR VERY GOOD REASONS, MEMBERS OF COUNCIL ARE WELL ESTABLISHED AND EXPERIENCED INVESTIGATORS OR OTHERS WHO HAVE IMPORTANT PERSPECTIVES AND VIEWS TO CONTRIBUTE TO THE INSTITUTE BUT ONE DOES WONDER THE EXTENT TO WHICH A GROUP OF ESTABLISHED INVESTIGATORS CAN UNDERSTAND THE PERSPECTIVES OF A MORE JUNIOR INVESTIGATOR AND PARTICULARLY GIVEN THE EXPERIENCE OF ALL OF OUR INVESTIGATORS BUT PARTICULARLY JUNIOR INVESTIGATORS AND TRAINEES DURING THE PAST 18 MONTHS. NOW IS AN IMPORTANT TIME WE MAKE SURE WE UNDERSTAND THEIR CONCERNS AND THEIR PERSPECTIVES. THAT'S PART OF THE SUGGESTION. >> I'D WELCOME OTHER THOUGHTS YOU HAVE AND LOOK FORWARD TO HEARING FROM YOU TOPICS WE SHOULD BE AWARE OF AND FOCUS ON. WHAT ARE GOOD WAYS FOR COUNCIL MEMBERS TO SUGGEST POSSIBLE TOPICS FOR OUR CONSIDERATION AND DISCUSSION? THEY CAN COME IN ONE-ON-ONE, OF COURSE, OR ONE OR MORE MEETINGS BUT WITH THE OPPORTUNITIES FOR YOU TO SHARE IDEAS AMONGST YOURSELVES ABOUT TOPICS THAT REALLY RESONATE AND ARE RELEVANT TO MANY MEMBERS OF OUR COMMUNITY. I'M INTERESTED IN YOUR THOUGHTS ON OTHER THINGS WE CAN DO AND WE ONLY HAVE YOU FOR A FEW MINUTES SO I'D LIKE TO MAKE THE BEST USE OF YOUR TIME AND EFFORT. >> SOMETIMES A WORKING GROUP LIKE YOU SAID YOU CAN PROVIDE INFORMATION ONE-ON-ONE BUT SOMETIMES THERE'S A SYNERGY WHEN PEOPLE ARE TOGETHER AND YOU HEAR SOMEBODY ELSE SAY SOMETHING AND IT MAKES YOU THINK OF SOMETHING ELSE SO THAT MIGHT BE USEFUL TO HAVE SOME WORKING GROUPS OR ALMOST I GUESS WHAT YOUR LOOKING FOR ARE BRAIN STORMING TYPE THINGS. >> THIS IS KAREN. WHEN DR. CRISWELL AND I VISITED AND PROBABLY BECAUSE OF THE MANY SPECIALTIES THAT DISEASE CARRIES OVER TO. I'M BIG ON LET'S DO WHAT WE CAN TO LEARN FROM ONE ANOTHER AND MANY OF THE SKIN CONDITIONS THAT'S WHY I WAS TICKLED ABOUT THE INFLAMMATION BUT I LEARNED SO MUCH FROM Y'ALL WITH LUPUS AND ALL THE DIFFERENT TYPES OF DISEASES. I LIKE THE IDEA OF THE GROUPS COMING TOGETHER AND BRAIN STORMING AND WHAT MAKES ME GO, OH, YEAH, WHAT ABOUT THIS. >> THANK YOU. >> LET ME ALSO SHARE SOMETHING I HEARD FROM DR. CARTER AND OTHERS AS ANOTHER IDEA. A FEW YEARS BACK MAYBE BEFORE MOST OF YOU WERE ON THE COUNCIL, A TRADITION WAS ESTABLISHED IN WHICH A SUBSET OF COUNCIL MEMBERS GOT TOGETHER. THIS WAS BACK IN THE GOOD OLD DAYS WHEN THE MEETINGS WERE IN PERSON BUT WOULD GATHER THE EVENING BEFORE THE COUNCIL MEETING AND DEVELOP A LIST OF TOPICS THEY THOUGHT WERE IMPORTANT FOR THE INSTITUTE TO CONSIDER AND HAVE THE BENEFIT OF BASICALLY A BRAIN STORMING SESSION ONCE THOSE ARRIVING FROM OUT OF TOWN HAD ARRIVED. NOW, WE WOULDN'T BE ABLE TO FULLY ADDRESS THOSE TOPICS THE FOLLOWING DAY BUT THEY WOULD BE GREAT OPPORTUNITIES TO GET THINGS ON OUR RADAR SCREEN THAT WE MAY NOT BE THINKING ABOUT OR MAY BE ALIGNED WITH SOME TOPICS WE WERE THINKING ABOUT AND IMPORTANT TO KNOW THEY WERE IMPORTANT TO COUNCIL. THAT INVOLVES EXTRA TIME AND EFFORT BUT THROW THAT OUT AS SOMETHING ADOPTED IN THE PAST AND MAYBE SOMETHING LIKE THAT YOU ALL MAY WANT TO CONSIDER. >> THIS IS TONY. I WAS ON THAT AT THE VERY BEGINNING OF MY TENURE. IT WAS VERY HELPFUL BECAUSE THERE WAS A MEMORY OF A LIST OF TOPICS AND IT PROVIDED MEMORY FOR THE COUNCIL MEMBERS FOR CONTINUITY OF TOP ICS THAT WERE ON THE MINDS OF THE FOLKS. THAT INCLUDED BOTH PATIENT TOP -- TOPICS AND CLINICAL TRIAL TOPICS AND WAS IMPORTANT TO REMIND THE COMMUNITY OF WHAT WERE THE TOPICS OF HAND. I THOUGHT THAT WAS VERY USEFUL. >> I REALLY LIKE THAT IDEA AS WELL. I CAME IN LATER BUT I REALLY LIKE IT BECAUSE WHEN WE HAVE THE AGENDA SET BEFORE US, WE MIGHT HAVE RANDOM IDEAS IN OUR HEADS BUT IT DOESN'T SEEM APPROPRIATE TO SPRINKLE THEM IN HERE AND THERE WHERE IT'S NOT THEMATICALLY CON GREW US AND HAVING THE OPPORTUNITY TO BRING UP TOPICS WOULD BE FANTASTIC. >> THAT'S GREAT. >> AND I CAN APPRECIATE THE BALANCING BETWEEN WANTING TO SHARE IDEAS AS THEY COME TO MIND AND ALSO BEING MINDFUL OF THE AGENDA FOR THE PARTICULAR MEETING BUT WE WILL HAVE SEVERAL DISCUSSION SECTIONS THROUGHOUT THE DAY. MOST FOLLOWING SPECIFIC TOPICS AND PRESENTATIONS BUT WE WILL HAVE AN OPEN PERIOD FOR DISCUSSION IN THE CLOSED PERIOD AS WELL SO WE CAN BEGIN THAT PROCESS AND TOPICS UNRELATED TO THE FOCUS TODAY WOULD LOVE TO HEAR THINGS ON YOUR MIND SO WE CAN START THINKING ABOUT THOSE AS WELL. SO PLEASE FEEL FREE TO SHARE THOSE IDEAS THAT DON'T RELATE TO ANY OF THE AGENDA ITEMS TODAY AT THAT POINT. >> I WOULD ECHO EVERYTHING THAT'S BEEN SAID. EVEN GREATER INPUT IS WELCOMED. I THINK WE'RE ALL AWARE DURING THE TIME WE ARE SERVING ON THIS COUNCIL WE ARE IN FACT ALLEVIATED OF OTHER DUTIES AND ARE NOT ALLOWED TO ACTUALLY PARTICIPATE IN OUR USUAL REVIEW FORUMS. FOR THAT ALONE THE EXPECTATION IS THAT ACCEPTING THIS POSITION IS TO PROVIDE FURTHER INPUT AND IT COULD BE TOPICS THAT WE ACTUALLY SHARE WITH YOU THAT COULD ADVANCE AN AGENDA. FOR EXAMPLE, THE IDEA OF SELECT PAY. A LOT OF US ARE STILL TRYING TO UNDERSTAND WHAT THAT MEANS AND WHAT MIGHT BE OUR ROLE. WE READ THE ELECTRONIC COUNCIL BOOK AND TRY TO UNDERSTAND THE PAY LINES. WE SEE GRAY AREAS BUT PERHAPS A CONSENT THAT MIGHT BE INTRODUCED IS WHAT DOES THAT MEAN AND DO WE HAVE A POSSIBLE OPPORTUNITY TO CONTRIBUTE TO THAT QUOTE, GRAY AREA, WHETHER IT'S AN INVESTIGATOR WHO MIGHT NOT BE ABLE TO MAINTAIN THEIR LABORATORY, SOMEBODY ON THE BRINK WHO IS AN E.S.I. I THINK THERE COULD BE SUBSETS OF TOPICS WE AS COUNCIL MEMBERS MAY BE ABLE TO CONTRIBUTE TO. THAT'S JUST ONE IDEA BUT SOMETHING LIKE THAT. >> THANK YOU, JILL. AND THAT REMINDS ME BECAUSE I'M STILL NEW AND I'VE BEEN ASKING LOTS OF QUESTIONS ABOUT HOW DO INSTITUTES DO X, Y AND Z ONE QUESTION I'VE OPPOSED IS HOW DO YOU WORK WITH COUNCIL. THERE'S QUITE A LOT OF VARIABILITY. THAT'S ALSO SOMETHING WE CAN DISCUSS AT SOME POINT AT THE RANGE OF POSSIBILITIES AND IT'S WIDE RANGING FROM WHAT I'VE LEARNED. THANK YOU FOR EXPRESSING YOUR INTEREST IN THAT PARTICULAR TOPIC. >> I LIKED THE E-FORMAL DINNER AND PROVIDES A GREAT ENVIRONMENT FOR COUNCIL MEMBERS TO GET TO KNOW EACH OTHER AND BOUNCE IDEAS BETWEEN FIELDS AND ALSO FOR THE OTHERS TO JOIN US AND CHAT IN THIS INFORMAL SETTING AND MAYBE WE'LL COME UP WITH UNEXPECTED IDEAS FOR THE INSTITUTE. >> YEAH. >> YES, THANK YOU. SEVERAL OF YOU I REMEMBER WHEN WE SPOKE THE BREAKS AND THE LUNCH BREAK AND THE NIGHT BEFORE WERE TERRIFIC OPPORTUNITIES ALSO FOR YOU TO GET TO KNOW EACH OTHER AND UNDERSTAND THIS IS A GOOD NETWORKING OPPORTUNITY OR I NOW UNDERSTAND TOPIC OVERLAP BETWEEN SEVERAL COUNCIL MEMBERS AND MAYBE NOT ALL HAVE THAT FULL AWARENESS. AT THE NEXT MEETING IT WILL BE VIRTUAL BUT WE'RE LOOKING FORWARD TO HAVING MEETINGS AGAIN IN PERSON WHEN WE CAN JUST SO WE ACTUALLY CAPTURE THE TIME TOGETHER AND MAKE THE MOST OUT OF IT. >> MAY I START THE DISCUSSION ON THE BUDGET. SO IT'S REALLY EXCITING THAT NIH IS SUPPOSEDLY GOING TO INCREASE BUDGET OVERALL AND PROBABLY NIAMS AND GET LIKE A 7% INCREASE IF THE BUDGET PASSES. THAT'S EXCITING AND YOU MENTIONED MAINLY FOR THE OPIATE RESEARCH. WAS IS IT ABOUT AND WHAT AREAS CAN NIAMS EXPAND ON THAT BUILDING ON THE EXISTING STRENGTH IN THIS AREA? >> SO, YES, IT'S A WONDERFUL OPPORTUNITY. AND PAIN IS A VERY HOT TOPIC. OUR AT THIS POINT AND THERE'S SEVERAL ON THE CALL WITH US TOO WHO SHOULD FEEL FREE TO CHIME IN IS IT'S PRETTY BROADLY DEFINED. FUNDING TO HEAL IS FOCUSSED ON PAIN AND OPIOID ABUSE AND RELATIONSHIPS THERE AND TENDS TO HAVE A SPECIFIC FLAVOR. BUT THE OTHER SUPPORT FOR PAIN RESEARCH IS MUCH MORE OPEN AS FAR AS WE CAN UNDERSTAND WHICH IS GREAT NEWS FOR US. ONE OF THE THINGS YOU'LL HEAR LATER IN THE MEETING, WE WANT TO BE PREPARED TO MAKE THE BEST POSSIBLE USE OF FUNDS EVEN STARTING THE FIRST YEAR WHICH MEANS WE NEED TO BE READY TO HIT THE GROUND RUNNING ONCE THE BUDGET IS APPROVED AND WE SEE HOPEFULLY THAT THOSE ADDITIONAL RESOURCES ARE THERE. SO IN ORDER TO BE PREPARED FOR EXAMPLE TO BE ABLE TO DEVELOP FOAs WE HAVE TO HAVE CONSENTS CLEARED BY THE COUNCIL. YOU'LL HEAR TWO COUNCILS. ONE MORE FOCUSSED ON THE HEAL PRIORITIES AND THEMES AND THE OTHER WHICH IS VERY BROADLY FOCUSSED ON PAIN. WE THINK WE'LL HAVE MANY OPPORTUNITIES TO CONSIDER HOW BEST TO USE THAT AND ONE QUESTION THAT WILL COME UP DOWN THE LINE IS HOW TO DEVELOP THE FOAs. SHOULD THEY BE RELATIVELY FOCUSSED TO ATTRACT INVESTIGATORS IN SPECIFIC AREAS TO APPLY FOR THE FUNDS OR ARE WE COMPLETELY WIDE OPEN AND ACCEPT ANYTHING WITHIN A PAIN PORTFOLIO AND THAT'S A STRATEGIC QUESTION. WHEN WE GET TO THAT POINT LATER IN THE MEETING I LOOK FORWARD TO DISCUSSING THAT FURTHER. AND GAYLE OR BOB, IF YOU HAVE ANOTHER INTERPRETATION OF THE PAIN BUT MY UNDERSTANDING IS IT'S QUITE BROADLY DEFINED AND WILL GIVE US A LOT OF FLEXIBILITY. >> I WOULD AGREE. I THINK ONE OF THE THINGS WE MAY START WITH IS MAYBE JUST A NOTICE OF INTENTION TO PUBLIC ONCE WE GET OUR ARMS WRAPPED AROUND WHETHER THE MONEY IS ACTUALLY GOING TO MATERIALIZE BECAUSE AS YOU SAW IT'S ONLY BEEN THROUGH THE HOUSE AND HAS NOT BEEN FINALLY APPROVED AND SIGNED BY THE PRESIDENT. WE STILL HAVE TWO BIG STEPS TO GO FOR THAT BUT WE'RE REALLY PUTTING IDEAS TOGETHER AND TRYING TO DECIDE AS DR. CRISWELL SAID WHAT THE BEST USE OF THESE FUNDS WOULD BE FOR OUR COMMUNITY. SO I WOULD SAY WE ALL WELCOME ANY IDEAS THAT ANY OF YOU HAVE WITH REGARD TO AREAS YOU FEEL ARE UNDER SERVED AND COULD BE IMPROVED OF GIVEN AN OPPORTUNITY FOR THIS PARTICULAR FOCUS ON PAIN. >> LET ME SAY MORE ABOUT THE PROCESS. SO WE HAVE BEEN THINKING ABOUT THIS OPPORTUNITY INTERNALLY AMONG OUR STRATEGY PLANNING GROUP AND ALSO NOW THE PROGRAM OFFICERS ARE THINKING CAREFULLY AND CREATIVELY ABOUT THE IMPORTANT OPPORTUNITIES WITHIN THE NIAMS MISSION AREAS WITH RELEVANCE TO PAIN. WE NOW HAVE THIS OPPORTUNITY WITH YOU TODAY, ONCE AGAIN, FOLLOWING THE CONSENT CLEARANCE AND THEN IN THE OPEN DISCUSSION TO HEAR FROM YOU ABOUT IDEA YOU MAY HAVE ABOUT PAIN AND BRING ALL OF THESE IDEAS TOGETHER TO THINK ABOUT NOTICE OF INTENT TO PUBLIC AND SPECIFIC FOAs. SO IN ADDITION -- I THINK I INTRODUCED THIS TOPIC TO MOST OF YOU ON ONE-ON-ONE CALLS TO START THINKING ABOUT THAT. WE'RE EAGER TO HEAR YOUR SUGGESTIONS. WHAT ARE THE MOST IMPORTANT GAPS, OPPORTUNITY AREAS RELATED TO PAIN SO -- ONCE AGAIN WE HAVE A DISCUSSION TIME FOLLOWING THE OTHER TOPICS IN THE AGENDA SO WE HAVE MORE TIME TO HAVE DISCUSSION. ANYTHING ELSE THAT FOLKS WOULD LIKE TO INTRODUCE NOW FOR OUR CONSIDERATION AT THIS POINT IN THE MEETING? >> THIS IS TONY. I'D LIKE TO GO BACK TO THE DISCUSSION ABOUT LEVERAGING AND BIG VERSUS SMALL TYPES OF PROGRAMS. I DON'T KNOW IF WE FINISHED THAT DISCUSSION BUT I THINK IT'S USEFUL TO TALK ABOUT HOW DO YOU LEVERAGE THE SMALL INSTITUTE, LIKE MAINTAIN THE PAY LINE BUT ALSO YOU KNOW, BITING OFF LARGE PROGRAMS OF IMPORTANCE TO THE CONSTITUENTS? I THINK THE IDEA OF LEVERAGE AND HOW TO LEVERAGE THE CROSS CAMPUSES AND WITHIN INDUSTRY I THINK IS STILL A BIG ISSUE. I'D LIKE TO THROW THAT OUT ONE MORE TIME BECAUSE I THINK IT'S A BIG ISSUE AS WE'RE TRYING TO FIGURE OUT WHAT TO DO IN THE FUTURE. >> SO, I COULD NOT AGREE MORE AND THIS, WE SHOULD ALWAYS BE THINKING ABOUT THIS. THIS IS NOT A ONE-TIME DISCUSSION. SO I THINK THAT'S CRITICALLY IMPORTANT. I THINK THE INSTITUTE HAS BENEFITTED TREMENDOUSLY FROM LEVERAGING AND SEVERAL PROJECTS THAT COME TO MIND IMMEDIATELY SUCH AS AMP. THAT'S A WONDERFUL OPPORTUNITY WHERE THERE'S INVESTMENT FROM MULTIPLE INSTITUTES AND CENTERS AND VERY SIGNIFICANT INSTITUTE SUPPORT. WE HAVE ALSO BENEFIT FROM HEAL FUNDS AND BACPAC HAS SCHOLARS AND AN INCREDIBLE OPPORTUNITY. AND THERE WAS ANOTHER BIG PROGRAM FUNDED. THERE'S THE COMMON FUND MECHANISM WHICH IS ALSO SOMETHING THAT WHICH DOES NOT IMPACT THE PAY LINE AND WE HAVE BEEN THINKING ABOUT MY GOAL WOULD BE THAT EVERY YEAR WHEN THERE'S AN OPPORTUNITY TO PROPOSE IDEAS FOR THE COMMON FUND, NIAMS WOULD BE IN THERE. THERE IS A PROCESS AND IN ANOTHER COUPLE OF MONTHS THERE WILL BE A SESSION OF NIH LEADERSHIP TO DISCUSS POTENTIAL IDEAS FOR COMMON FUNDING AND MY GOAL IS TO HAVE NIAMS GENERATED IDEAS OFTEN IN FRONT OF THE OTHER INSTITUTE DIRECTORS AND DR. COLLINS AT EVERY YEAR AND WE'RE THINKING ABOUT THAT IN FUNDING AS WELL AND THERE HAVE BEEN BEFORE MY TIME THERE HAVE BEEN COMMON FUND PROJECTS THAT BENEFITTED OR WERE ORIGINATED FROM NIAMS' LEADERSHIP THE PROMISE MEASURES IS ONE EXAMPLE. AND I'M SURE THERE ARE OTHERS THAT I'M NOT THINKING ABOUT AT THE TIME. SO I HAVE THE OPPORTUNITY TO MEET WITH DR. COLLINS ON A QUARTERLY BASIS AND IT'S AN OPPORTUNITY FOR ME TO KIND OF CONTINUE TO MAKE HIM AWARE OF OUR PRIORITIES AND TO LEARN FROM HIM HOW THOSE MIGHT OVERLAP WITH OTHER INSTITUTES. OH, AND BOB JUST REMINDED ME. SO MOTOR PAC ANOTHER EXAMPLE AND I KNEW I WAS FORGETTING ONE. THE MORTAR -- MOTOR PAC PROGRAM AND IT TAKES A LOT OF SOCIAL RELATION AND GETTING OTHER INSTITUTES ON BOARD WITH THE IDEA AND ADVOCACY WITHIN COLLEAGUES AT THE NIH AND THEN FURTHER REFINEMENT IN THE CONTEXT OF THE LEADERSHIP FORUM HELD EVERY YEAR, ETCETERA. YES, THANK YOU. WOULD YOU LIKE TO SAY SOMETHING? >> YEAH, THANKS FOR THAT GREAT SUMMARY, LINDSEY BECAUSE THERE'S A LOT OF INSPIRING EXAMPLES AND THE CONSTITUENCY WOULD LIKE TO REPLICATE WHAT WAS DONE FOR OUR GROUPS AND WONDER IF IT WILL BE USEFUL IN THE FUTURE MEETING TO HAVE SOMEONE FROM THE DIRECTOR'S OFFICE WHERE THEY PUT TOGETHER THE WARP SPEED AS IN FOR THE VACCINE AND WHAT ARE BEST WAYS TO INTERFACE WITH INDUSTRY AS A WHOLE BECAUSE WE TALK ABOUT THE CHALLENGE OF HOW TO KNOW WHAT IS THEIR GLOBAL OPINION AMONG ALL INDUSTRY GROUPS. I THINK THEY TEND TO BE BALKANIZED GROUPS BUT TRYING TO EXTRACT A COMMON INTEREST THAT COULD FUEL THE NEXT AMP IS AN ISSUE AND MAYBE HAVING SOMEONE WITH A LOT OF EXPERIENCE ALREADY INTERFACING NIH AND INDUSTRY TALKING TO OUR GROUP MIGHT BE HELPFUL. THAT'S ONE IDEA FOR THE FUTURE. >> YES, THANK YOU FOR RAISING THAT IMPORTANT POINT AND I'M PLEASED TO SEE HOW MUCH SUPPORT FOR INDUSTRY AND OTHER PARTNERSHIPS THAT IS CLEARLY THAT'S A PRIORITY FOR THE NIH RIGHT NOW. ONE QUESTION I HAVE AND WE'LL HAVE TO HAVE ONGOING DISCUSSIONS INTERNALLY AS WELL, THE FOUNDATION FOR NIH PLAYS AN IMPORTANT ROLE BETWEEN INDUSTRY PARTNERS AND NIH INITIATIVES. FOR SURE, THAT'S AN IMPORTANT PLAYER, STAKEHOLDER OR ADVISER IN THE TOPIC. THE EXTENT TO WHICH A PRESENTATION OR DISCUSSION WITH THEM IS THE RIGHT PLACE TO START IN TERMS OF THAT TOPIC OR WHETHER THERE'S OTHER THINGS WE SHOULD BE THINKING ABOUT. I'D LIKE TO UNDERSTAND BETTER THE BEST SOURCE OF ADVICE WE MIGHT GET FOR HOW TO IDENTIFY AND LEVERAGE THE OPPORTUNITIES. I'VE BEEN IMPRESSED SO FAR WITH HOW WELL THE FMIH HAS PLAYED THE IMPORTANT ROLE THEY HAVE AND WITH DEVELOPING RELATIONSHIPS WITH A NUMBER OF INDUSTRY PARTNERSHIPS AND THEN HELPING TO SECURE SUPPORT FOR IMPORTANT NIH PRIORITIES. BOB, PLEASE FEEL FREE TO CHIME IN. YOU'VE HAD A LOT OF MORE EXPERIENCE IF YOU HAVE OTHER THOUGHTS AT THIS POINT. >> LUIS, EMBEDDED IN YOUR COMMENTS IS WE DON'T ALWAYS UNDER THE PERSPECTIVE OF INDUSTRY AND I AGREE WITH THAT. WE'VE HAD A LOT OF MEETINGS WHERE AT THE END OF THE MEETING I WASN'T SURE WHERE THEY WERE COMING FROM BUT YOU'RE RIGHT, THEY DON'T SPEAK WITH ONE VOICE AND EVEN WITHIN A COMPANY UNLESS HAVE YOU THE DIRECTOR OF R&D AND YOU WILL HAVE A CONVERSATION WITH THE SUBJECT MATTER EXPERT ON WHATEVER DISEASE AND THEY'RE IN THE SAME POSITION AS AN INVESTIGATOR. THEY'RE TRYING TO SELL TO THEIR LEADERSHIP. THEY'RE NOT SPEAKING FOR THE LEADERSH LEADERSHIP. I DO AGREE IN TRYING TO UNDERSTAND WHERE A COMPANY OR INDUSTRY IS COMING FROM WITHOUT ASKING FOR DOLLARS COULD BE QUITE INTERESTING. CERTAINLY LARRY'S DONE THIS AND FRANCIS A LOT BUT WE CAN ASK FRANCIS, THE ACTING DIRECTOR OF FNIH HAS THAT PERSPECTIVE BUT HE'S GOT TO LOOK OUT FOR THE PERSPECTIVE OF FNIH BUT YOUR COMMENT IS INTERESTING AND IMPORTANT BECAUSE WE DON'T UNDERSTAND SOMETIMES WHERE THEY'RE COMING FROM AND THAT MAKES IT HARD TO PITCH THINGS. >> THANK YOU. I COMPLETELY AGREE. JOAN. >> MY QUESTION ON WHAT THE COMMON FUND IS MADE UP OF IS A CERTAIN PERCENTAGE OF THE NIH BUDGET EVERY YEAR AND HOW THAT WORKS AND WANTED TO FOLLOW-UP ON THE PREVIOUS CONVERSATION AS MUCH AS WARP SPEED WAS AMAZING, NIAID HAD AMAZING WARP SPEED IN GETTING CLINICAL TRIALS ORGANIZED AND THEY HAD AN EXISTING NIH -- HIV CLINICAL TRIALS RESEARCH NETWORK AND GOT THEIR PROTOCOLS THROUGH THE IRB IN WARP SPEED AND NUMEROUS CLINICAL TRIALS UP AND GOING FOR COVID WHICH WAS THE FASTEST THING I'VE EVER SEEN FOR NIH CLINICAL TRIALS. WE DON'T HAVE ANYTHING LIKE THAT IN NIAMS TO MY KNOWLEDGE. NIAMS HAS NEVER BEEN INTERESTED IN SUPPORTING NETWORKS LIKE THAT, AS FAR AS I KNOW. I DON'T KNOW IF THERE'S JUSTIFICATION FOR IT OR NOT BUT TO HAVE THEM BUT I THOUGHT I'D THROW THAT OUT. >> YEAH, AND LET ME SAY THE CLINICAL TRIALS IS A TOPIC I'VE HEARD FROM SEVERAL ABOUT AND LOOK FORWARD TO DIVING INTO TOPIC. I WAS ASKED TO SERVE ON A TRANS-NIH TASK FORCE AND IT WAS PROMPTED IN PART AS A FOLLOW-UP TO THE BIG EFFORT THAT THE NIH UNDERTOOK FIVE OR SIX YEARS AGO THAT RESULTED IN A NUMBER OF RECOMMENDATIONS AND THE QUESTION IS HAVE THEY BEEN IMPLEMENTED, IF NOT, WHY NOT AND WHAT ARE THE NEEDS AND IT'S BROAD AND PERSPECTIVE CONSIDERING WHAT WILL HELP THE NIH, FOR EXAMPLE, TO BE ABLE QUICKLY PIVOT TO SOMETHING LIKE COVID AND WHAT IS HAPPENING IN THE EXTRAMURAL WORLD. I THINK IT WILL BE INTERESTING. SO IT PROMPTED IN PART BY FOLLOW-UP TO THAT PREVIOUS EFFORT BUT ALSO BY SOME FRUSTRATION AND CHALLENGES THAT BECAME APPARENT WHEN MANY INSTITUTIONS WERE CHALLENGED TO PIVOT TO FOCUS ON COVID TRIALS AS QUICKLY AS SAY DR. COLLINS OR OTHERS WOULD HAVE LIKED TO HAVE SEEN. SO THAT IS GOING TO BE AN ONGOING EFFORT AND I LOOK FORWARD TO BRINGING THESE ISSUES BACK TO YOU BECAUSE WE'RE NOT A BIG INSTITUTE. WE DON'T HAVE -- IF WE WERE TO SPEND A LOT MORE MONEY ON CLINICAL TRIALS IT WOULD IMPACT OTHER AREAS WE'RE CURRENTLY FUNDING AND IT'S IMPORTANT TO THINK OF THE MOST EFFECTIVE WAYS TO SUPPORT OUR CLINICAL TRIALS. TO BE CONTINUED, FOR SURE. MARY, I SEE YOUR HAND UP. >> THIS IS A LITTLE BIT BACK ON THE PREVIOUS DISCUSSION ABOUT INTERACTING WITH INDUSTRY BUT IS THERE A PRECEDENT OR MECHANISM TO HAVE A CORPORATE ADVISORY BOARD TO HAVE REGULAR INPUT AND COULD -- THERE'S A DIVERSITY OF INDUSTRY TO BE CONSIDERED. THE QUESTION WAS IS THERE ANY INSTITUTE HAVE THAT OR IS THAT SOMETHING ONE COULD FORM? >> WE'RE STILL REELING FROM THE MACK STUDY WHERE NIH GOT TOO CLOSE TO THE ALCOHOL INDUSTRY. I THINK THE PENDULUM'S SWUNG THE OTHER WAY. AND OBVIOUSLY WE CANNOT CANNOT ASK INDUSTRY FOR DOLLARS OR ANYBODY REALLY INCLUDING NONPROFITS. IN TERMS OF HAVING DISCUSSIONS OF SHARED INTERESTS, FNIH WOULD HAVE PREVIOUS MECHANISMS BUT WOULD WONDER IF THERE'S SOME WAYS AND MAYBE SOME ORGANIZATIONS COULD HELP WITH THOSE DISCUSSIONSES. THEY COULD BE A -- DISCUSSIONS. THEY COULD BE A BROKER. IT DOESN'T COVER EVERYBODY BUT MOST PEOPLE WHO GO TO THE MEETINGS WOULD HAVE SOME PARTICULAR INTEREST IN MIND. BUT THAT MIGHT BE AN AVENUE. SOMETHING LIKE THAT. IT WOULD BE INTERESTING AND AGAIN WHAT YOU WOULD TRY TO DO IS GET THE INDUSTRY PEOPLE TO SAY SOMETHING A LITTLE MORE DEFINITIVE SOMETIMES. >> I WONDER WHETHER THIS IS A TOPIC WE COULD INTRODUCE AT THE UPCOMING COALITION MEETING TO MEET WITH THE GROUPS. MAYBE SOMETHING -- AND FIRST I AGREE WE NEED TO FIRST UNDERSTAND THE CONSTRAINTS OR THE BOUNDARIES WE NEED TO RESPECT BUT THEN FIND OUT WHAT SORT OF OPPORTUNITIES WE MIGHT HAVE TO DEVELOP THAT SORT OF A RELATIONSHIP AND ADVICE. THANK YOU. I THINK, SUE, PLEASE. >> I WANTED TO OFFER AND THIS BLENDS WELL WITH YOUR LAST COMMENT ABOUT THE COALITION MEETING. I BELIEVE YOU STILL HAVE ARTHRITIS FOUNDATION REPRESENTATION ON THE COALITION. THE A.F. DOES AN INDUSTRY FORUM OR AT LEAST THEY HAVE FOR SEVERAL YEARS AND THEY BRING MULTIPLE STAKEHOLDERS INCLUDING MULTIPLE INDUSTRY MEMBERS INTO A ROOM TO TALK ABOUT MANY OF THESE SAME THING, WHAT ARE THE HIGH PRIORITY RESEARCH AREAS AND UNMET CLINICAL NEEDS. THAT MAY BE A WAY TO LEVERAGE SOMETHING ALREADY IN EXISTENCE AND WOULDN'T BE AN ADDITIVE STEP. DEFINITELY, RAISE THAT WITH THE ARTHRITIS FOUNDATION AS A POTENTIAL SOURCE FOR COLLABORATION AND INPUT. >> THANK YOU SO MUCH. BY THE WAY, SOMEONE IS TAKING NOTES OF ALL THESE GREAT SUGGESTIONS SO WE DON'T FORGET THESE. LEE, YOUR HAND IS UP. WOULD LOVE TO HEAR WHAT YOU HAVE TO SAY AT THIS POINT TOO. >> TO FOLLOW-UP ON THAT, I'VE HAD EXPERIENCE IN THE ALZHEIMER'S WORLD WHERE INDUSTRY GOT TOGETHER IN A VERY COLLABORATIVE WAY IN A PRECLINICAL FASHION AND THAT SPECIFIC AREA WAS TRYING TO GET CLINICAL END POINTS OF WHAT MATTERS MOST TO THE PATIENT AND CAREGIVERS BUT THEY'RE WILLING TO DO A LOT WHEN IT'S GOING TO HELP EVERYBODY AND SO I THINK IF WE CAN ALSO TRY TO FIND COMMON THINGS THAT THEY'RE INTERESTED IN THAT WORKS WELL FOR THEM TO PLAY IN THE SAND BOX PRECLINICALLY. >> YES, THANK YOU. I SEE JILL AND TONY. NOT SURE WHOSE HAND WENT UP FIRST. MAYBE JILL AND THEN TONY IN ALPHABETICAL ORDER. >> ONE OF THE CHALLENGES WE NEVER THINK ABOUT BUT HAVE TO KEEP IN MIND IS THE TRANSIENT NATURE OF INDUSTRY AND LEADERSHIP AT THE HIGHEST LEVELS. THERE'S A MUCH MORE IN MANY WAYS BECAUSE YOU'RE NOT SURE WHO IS THE NEXT PERSON TO SIT AT THE TABLE AND IT EXISTS. SECOND IS WE RARELY TALK ABOUT GOING BACK TO THE MECHANISM OF DRILLING INDUSTRY LEVERAGING THE AMAZING COHORTS THEY HAVE ACCUMULATED AND TRYING TO FIGURE OUT HOW THAT CAN BE DONE IN A WAY WHERE ALL TEAMS BENEFIT. ONE DOESN'T WITHDRAW OR WORRY IF RESULTS NEGATIVE BUT IN REALITY, WE FORGET THAT THESE COHORTS ARE EXCEPTIONAL AND THE SCIENCE WE COULD BRING TO THEM, WE, I MEAN THE ACADEMIC COMMUNITY WOULD BE EXTRAORDINARY. AND LASTLY, AND THIS MAY BE SOMETHING THAT IS MAYBE TOO MUCH OF A CONFLICT OF INTEREST, BUT HOW OFTEN ARE MEMBERS OF INDUSTRY PARTICIPATING IN A REVIEW, IN A GRANT REVIEW. IS IT LEGAL, IS IT NOT? I SUSPECT IT IS BECAUSE WE ALL SIGN THE SAME CONFIDENTIALITY BUT HOW OFTEN DO WE HAVE INPUT WHETHER A CLINICIAN OR SCIENTISTS. THERE'S MANY CAPABLE PEOPLE IN OUR OWN ACADEMIC COMMUNITY WHO DECIDED TO JOIN INDUSTRY. I'VE ALWAYS THOUGHT, WELL, WHY NOT HAVE ONE OF THEM ON A REVIEW COMMITTEE BECAUSE THEY CERTAINLY HAVE A LOT OF EXPERTISE AND NOW THEY'RE CENTERED IN A DIFFERENT WAY. >> YES, FIRST, GREAT THOUGHTS ON LEVERAGING AND COHORTS ON THE PART OF INDUSTRY RELATES TO THE TOPIC OF CLINICAL TRIALS. INDUSTRY INVOLVEMENT INTERACTION. MY UNDERSTANDING IS THERE'LL BE INDUSTRY REPRESENTATIVES INVOLVED IN SOME WAY IN CONSIDERATION OF THE AMP/AIM PROPOSAL. WE HAVE A DISCUSS COMING UP ABOUT THAT AND I'M REMINDED OF COMMENTS MENTIONED IN TERMS OF INDUSTRY PERSPECTIVE IS VALUABLE WHEN IT COMES CLINICAL TRIALS AND STUDIES AS IS THE PATIENT PERSPECTIVE AND YOU TOUCH ON DIFFERENT TOPICS. TONY. >> TWO POINTS AND JUST TO FOLLOW-UP AGAIN. THERE'S A GOLDEN TRIANGLE OF WHEN SHARED SIGNS -- SCIENTISTS AND INDUSTRY GROUPS WORK TOGETHER AND SPUN OUT CLINICAL TRIALS FROM SOME MEDICINE PROGRAMS. WE SHOULD THINK TOGETHER IT IS A GOLDEN TRIANGLE OF SCIENTISTS AND INDUSTRY AND PATIENT GROUPS AND WE HAVE TO WORK TOGETHER AND SHOULD CONSIDER THINGS LIKE ONE TO ONE MATCHING PROGRAMS BECAUSE THAT BRINGS IN INDUSTRY AS WELL AS DOLLARS BECAUSE I THINK SCIENTISTS ARE EQUALLY AS TRANSIENT IN WHAT THAT CONSIDER AS INTERESTING AS COMPANIES ARE TRANSIENT. AND THE LAST POINT REALLY IS THERE'S AN EXAMPLE OF A COMMUNITY LIKE AMP AND SPIR IS ANOTHER AREA UNDER UTILIZED AND WE SHOULD MAKE USE OF THE SPIR AVENUE WHICH IS TONS OF MONEY AND THE FUNDING RATE IS LIKE 40%. IT'S UNUSED MONEY WHICH WE DON'T TAKE ADVANTAGE OF AND THE LAST COMMENT IS EVERYBODY HAS A CONFLI CONFLICT. IT'S JUST HOW YOU MANAGE IT AND WE HAVE TO GET AROUND AND STOP THINKING ABOUT HOW INDUSTRY IS CONTAMINATED OR LIKE YOU DIDN'T MANAGE THE CONFLICT WELL. >> THAT'S RIGHT. >> YOU'RE COMMENT ABOUT SPIR, IF I'M RECALLING CORRECTLY, I THINK WE HAVE VERY STRONG APPLICATIONS AND I THINK THE SUCCESS RATE IS WELL DIFFICULT LOW. GAYLE, ON THAT NOTE CAN YOU SAY A LITTLE BIT ABOUT THE SPIR? >> AS DR. CRISWELL SAID WE HAVE A VITAL SPIR/SGTR PROGRAM A PARTNERSHIP BETWEEN A COMPANY AND INVESTIGATOR AND ACADEMICS IS HIGHLY COMPETITIVE WITH THE SUCCESS RATE THERE IS NOT CLOSE TO 45% BUT THE SPIR SUCCESS RATE FOR COMPANY FUNDED RESEARCH AND SMALL BUSINESS IS VERY VITAL. WE ALWAYS USE ALL OF OUR DOLLARS. THERE ARE NO DOLLARS THAT GO TO WASTE. THE PROGRAM IS SUCH THAT IF YOU DON'T USE YOUR DOLLARS, OTHER INSTITUTES AND CENTER HAVE SPIR APPLICATIONS WORTHY OF BEING PAID CAN GET ACCESS TO THOSE DOLLARS TO COVER THOSE. SO IT REALLY IS HIGHLY UTILIZED AND DEVELOPS NEW PROGRAMS HOW TO GET IT COMMERCIALLY AVAILABLE FROM A SMALL BUSINESS AND HELPING BUSINESSES DO THE SPECIALIZATION PROCESS AND PUTTING THEM IN TOUCH WITH FUNDERS TO HELP THEM WITH VENTURE CAPITAL. THERE'S SOME REALLY GREAT THINGS, TONY, THANK YOU FOR BRINGING THAT UP ASSOCIATED WITH THE SPIR PROGRAM. >> OTHER COMMENTS AND THINGS TO SHARE BASED ON THE TOPICS INTRODUCED OR SOMETHING WE HAVEN'T TOUCHED UPON YET. IF NOT WE CAN MOVE ON TO THE NEXT SEGMENT BUT I'M LOOKING AROUND. FORTUNATELY, I CAN SEE ALL OF YOU ON MY SCREEN AND I DON'T SEE HANDS UP. WE'RE RUNNING A FEW MINUTES AHEAD OF SCHEDULE WHICH IS GREAT BECAUSE WE'RE LIKELY TO NEED ANYTIME IN ANOTHER SESSION. NEXT PORTION OF OUR MEETING IS GOING TO BE FOCUSSING ON THE AMP/AIM WORKING GROUP AND TIME LINE I MENTIONED BRIEFLY IN MY COMMENTS. TO GET EVERYBODY ON THE SAME PAGE, SO ONE OF THE INITIAL PROJECT WAS LAUNCHED BY THE ACCELERATING MEDICINES PROGRAM ALSO KNOWN AS AMP WAS IN RHEUMATOID ARTHRITIS AND LUPUS AND WAS DISCUSSED IN PREVIOUS COUNCIL MEETINGS INCLUDING THE LESSONS LEARNED PRESENTATION AND THOSE LAST HERE HEARD ABOUT IT IN MAY AND THE PROJECT IS NOW TRANSITIONING TO A NEW PROJECT CALLED AMP AUTO IMMUNE MEDIATED DISEASES OR AIM WHICH INCORPORATED THE LESSONS LEARNED FROM THE ORIGINAL AMP PROGRAM. THE APPLICATIONS ARE IN. THE REVIEW WILL TAKE PLACE NEXT MONTH. I'VEN AMP SAY PARTNERSHIP WE STRIVE TO INCLUDE PARTNERS IN DECISIONS BUT WITHIN THE RULES FOR DECISION MAKING AT NIH. TO THIS END WE PLAN TO FORM A WORKING GROUP OF COUNCIL TO INCLUDE REPRESENTATIVES FROM EXTERNAL PARTNERS AND ACADEMIC RESEARCHERS NOT IN CONFLICT BACK TO THE CONVERSATION WE WERE JUST HAVING AND WITH ALL NIAMS COUNCIL WORKING GROUPS IT WILL BE CHARGED WITH PROVIDING FINDINGS AND RECOMMENDATIONS BACK TO THIS BODY, YOU, COUNCIL. SO NIAMS HAS TAKEN THE LEAD IN ANOTHER CONSENT BEING DEVELOPED WITHIN THE AMP PROGRAM WHICH WILL USE AMP AS A PLATFORM FOR A SYSTEM'S BIOLOGY APPROACH TO ANALYSIS OF INFLAMMATION ACROSS DIFFERENT DISEASES. SO I'VE ASKED DR. CARTER TO REVIEW THE TRANSITION TO AMP/AIM. SECOND, THE FORMATION OF THE WORKING GROUP AND THIRD THE NASCENT AMP SYSTEMS BIOLOGY OF INFLAMMATION CONSENT. BOB, I TURN THINGS OVER TO YOU, NOW. >> THANKS, YOU ADJUST GAVE MY TALK FOR ME. THIS IS IS THE AMP TALK. THIS WOULD BE AN UPDATE ON SEVERAL DIFFERENT FACETS AS IT RELATE TO AMP AND AIM. IT IS A PARTNERSHIP. IT'S A NICE SEGUE FROM THE CONVERSATION LAUNCHED BACK IN 2014. IT'S BEEN REMARKABLE HOW MANY DIFFERENT PEOPLE AND COMPANIES AND INSTITUTES, NON-PROFITS, ADVOCACY GROUPS HAVE CONTRIBUTED TO THIS WITH THE GOAL OF DEVELOPING NEW THERAPEUTICS AND DIAGNOSTICS BASED ON THE PROBLEMS INDUSTRY HAS WHEN IT COMES TO LATE STAGE FAILURES. WE NEED TO DO A BETTER JOB UNDERSTANDING THE PATHWAYS. AND THE EMPHASIS WAS ON DISEASE DECONSTRUCTION. THE INNOVATIVE ASPECT WAS TAKING A PART THE TISSUES AND ISOLATING THE SINGLE CELLS OF TISSUES FROM PATIENTS WITH DISEASE AND USING THOSE FOR EMERGING TECHNOLOGY FOR SINGLE CELL ANALYSIS. AND IN ASSOCIATED TISSUES LIKE URINE AND LUPUS AND BLOOD IN BOTH OF THEM. SO THE INTERESTING THING WAS WE COULD SEE DIFFERENT TISSUE PATHWAYS ACTIVE IN THE SITES OF DISEASE AND GAVE NEW INSIGHTS INTO THE DISEASES. THESE NEXT TWO SLIDES ARE QUITE BUSY BUT IT WAS DONE WITH RHEUMATOID ARTHRITIS AND ON THE LEFT YOU CAN SEE DIFFERENT ANALYSES WERE DONE INCLUDING PROTEIN EXPRESSION AND RNA AND TRANSCRIPTOMICS AND IN ADDITION WORK IN RNA PROTEIN SO PROTEIN ANALYSIS AND PERIPHERAL BLOOD CELLS ALL ON BACKGROUND OF CLINICAL AND DEMOGRAPHIC DATA ON THE PARTICIPANTS INCLUDING FOLLOW-UP. IN LUPUS ASSAYS WERE RESTRICTED ON THE KIDNEY SAMPLES BECAUSE OF LIMITED AMOUNT OF CELLS WE COULD GET AND DID EXTENSIVE WORK ON THE URINE AND BLOOD AND INTERESTING WORK IN TERMS OF THE SINGLE CELL AND URINE CELLS AND BIOMARKERS POINTING TOWARDS NEW WAYS OF TREATING AND DIAGNOSING LUPUS. THE TRADITIONAL HISTOLOGY AND IMMUNOFLUORESCENCE BEING DONE AND A LIMITED NUMBER OF TISSUE SAMPLES BY SPECIAL TECHNOLOGIES INCLUDING TRANSCRIPTOMICS. SO NOW, AMP, RNA LUPUS IS TURNING TO AMP AIM AND ONCE AGAIN THE PARTNERSHIP INCLUDING US AND NIAID BUT NOW ALSO WITH NIDDK AND THE OFFICE OF RESEARCH ON WOMEN'S HEALTH AS WELL AS THE FMIH. THE NEW DIRECTION HERE WAS WE BUILD ON WHAT WAS DONE ON THE FIRST PHASE WHERE WE STUDY THE CELLS IN ISOLATION WHERE THE FOCUS IS UNDERSTANDING HOW THE DIFFERENT PIECES OF THE PUZZLE WE'VE IDENTIFIED ON THE SINGLE CELL ANALYSIS HOW THEY FIT TOGETHER AND HOW THE CELLS INTERACT TO CAUSE PATHOLOGY. THIS WOULD INCLUDE CAREFUL MAPPING OF THE CELLS USING SINGLE CELL ANALYTICS TO LOOK AT THE NEIGHBORHOOD AFFECTS INCLUDING MOLECULAR MEDIATORS AND HOW INFILTRATING IMMUNE CELLS ACTIVATE AND INTERACT WITH THE TISSUE CELLS THAT RESULT IN DISEASE. WE INCLUDED PSORIASIS AND THROUGH NICE AND A LOT OF WORK HAS GONE INTO THIS AND PARTNERSHIPS BETWEEN THE DERMATOLOGISTS AND ADDING SJOGREN'S SYNDROME AND ADDS TO THE RHEUMATOID AND SJOGREN'S TO THE LUPUS. IN ADDITIONAL BIOPSY CAN BE INCLUDED IF THE PARTNERSHIPS ARE THERE AND THERE ARE THESE OPPORTUNITIES. THE AMP/AIM WILL FOCUS ON DE CONSTRUCTING DISEASE MECHANISMS AS BEFORE AND BUILDING ON WHAT WE ACCOMPLISHED ALREADY AND SPATIAL MAPPING AND UNDERSTANDING HOW THE TYPES OF CELLS INTERACT AND IDENTIFY THE CROSS-TALK BETWEEN THEM THAT DRIVE INFLAMMATION AND LOOK AT THE COMPARISONS ACROSS AND EN TWIN TISSUES IN DIFFERENT DISEASE TO UNDERSTAND HOW DIFFERENT CELL TYPES INTERACT AND ADD TO DIFFERENT MANIFESTATIONS AS WELL AS PROVIDING A BETTER UNDERSTANDING AND WITH THE WORKING GROUP LOAD TO SIGNIFICANT CHANGES IN THE STRUCTURE. IN THIS CASE WE HAVE FOUR COMPONENTS. WE HAVE DISEASE TEAMS. WE'RE ASKING THESE TEAMS TO FORM THEMSELVES AHEAD OF TIME AND COME IN UNDER A SINGLE APPLICATION. AND WHEN WE HAVE THE TECHNOLOGY AND ANALYTIC COURSE AND TISSUE REPOSITORY AND TECHNOLOGY COURSE AND RESEARCH MANAGEMENT UNIT AND THE KNOWLEDGE PORTAL I MENTIONED EARLIER. IT DEPENDS ON IN THE FIVE YEARS WE EXPECT COULD HAVE ROBUST CLINICAL DATA SET AND ANALYTIC DATA ON TOPIC AND PATHWAYS TARGET IN THE TISSUES AND HOW THEY DIFFER BETWEEN DISEASE AND WE'LL HAVE NEW TOOLS FOR PROTEIN ANALYSIS AND COMPUTATIONAL TOOLS AND BASICALLY A ROAD MAP FOR HOW TO APPLY CONTEMPORARY MOLECULAR TECHNOLOGY TO STUDY DISEASES AND HOW TO PUT THOSE INTO A PORTAL TO BE ACCESSED AND STUDIED BY ANYBODY. TWO FUNDING OPPORTUNITIES WERE RELEASED THIS SPRING. ONE FOR THE DISEASE TEAMS AND ONE FOR THE DIFFERENT CORPS. THE APPLICATIONS WERE RECEIVED IN JULY AND THE FIRST LEVEL REVIEW AND PEER REVIEW AND STUDY SECTIONS IN A COUPLE WEEKS AND HOPE TO MAKE THE AWARDS BY THE END OF THE CALENDAR YEAR FOLLOWING A SPECIAL MEETING WITH COUNCIL TO PROVIDE THE SECOND LEVEL OF REVIEW. AS WE'VE DISCUSSED, WE WANT TO DEFINE WAYS TO HAVE INPUT FROM THE DIFFERENT PARTNERS WHO MAKE UP AMP INTO HOW THESE NETWORKS ARE STRUCTURED. IN THIS SLIDE IS VERY BUSY BUT IT THOSE DIFFERENT WAYS WHERE PARTNERS CAN HAVE INPUTS IN THE DIFFERENT RED BOXES THAT CAN INCLUDE INTO THE INITIAL CONSENT DEVELOPMENT AND TRY NOT TO INCLUDE THEM IN THE RFA APPLICATION PROCESS BUT CAN ON THE PEER-REVIEW COUNCILS AND IT'S MANAGING CONFLICT AND THE BIG THING WE'RE ADDRESSING IS THE PURPLE BOX TOWARDS THE BOTTOM LEVEL IS TO PUT TOGETHER A WORKING GROUP OF COUNCIL THAT WILL INCLUDE MEMBERS OF COUNCIL AND MEMBERS FROM ACADEMIA AND ALSO MEMBERS AND REPRESENTATIVES OF THE DIFFERENT PARTNERS WHO PARTICIPATE IN THIS AMP/AIM PROJECT. THEY WILL THEN MEET AND CONSIDER THE DIFFERENT APPLICATIONS AND THEN REPORT BACK TO YOU ALL COME THIS MEETING WE'VE TENTATIVELY SCHEDULED FOR EARLY DECEMBER. NOT A DONE DEAL YET BUT WHAT WE PLAN TO DO. THE GOALS OF THE WORKING GROUP -- THE MEMBERSHIP WILL BE DETERMINED BY NIAMS AND WHAT IT'S FUNCTION IS IS TO PROVIDE THE RECOMMENDATIONS BACK TO THE COUNCIL AND WE'RE NOT INTERESTED IN ASKING THEM TO DO A REAL REVIEW BY ANY MEANS OF ANY OF THE INDIVIDUAL APPLICATIONS, BUT TO HELP PROVIDE THE FINDINGS AND RECOMMENDATIONS TO THINK HOW TO BEST BUT TOGETHER THE NETWORK AND TO HELP IDENTIFY GAPS WHERE WE HAVE PIECES THAT MAY BE NEEDED. FOR EXAMPLE, IF A DISEASE TEAM SAYS WE NEED ANALYTIC Q AND WE HAVE X, Y AND Z WE HAVE TO FIND A WAY TO FIND ANALYTIC Q. THAT'S ONE WAY THE WORKING GROUP CAN HELP US. AND THEN PRESENTATION IN NOVEMBER IS THE CURRENT THINKING . AND THE SAME TIME LINE WITH THE WORKING GROUP MEETING IN OCTOBER TO PROVIDE THE INFORMATION WE CAN UNDER CONFIDENTIALITY AGREEMENTS TO GET THEIR INPUT AND PROVIDE THE RECOMMENDATIONS AND FINDINGS BACK TO COUNCIL AND THEN WITH NIAMS MAKE THE FINAL FUNDING DECISIONS BY THE END OF THE YEAR. I WILL OVERSEE THIS PROCESS BECAUSE LINDSEY MAY BE IN CONFLICT WITH CERTAIN APPLICATION. I WANT TO SWITCH GEARS NOW BUT I WANT TO INVITE YOUR COMMENTS AND FEEDBACK ABOUT THE PLAN WHEN I FINISH MY REMARKS. I WANT TO MENTION THE NASCENTEST OF SYSTEMS BIOLOGY AND INFLAMMATION. I THINK THEY'RE UP TO SEVEN AMP PROJECTS BUT FOR OUR FIVE HAVE SIMILAR TYPES OF OMICS DATA AND OFTEN FROM DIFFERENT TISSUES AND SOMETIMES DIFFERENT OMICS LIKE SOME EMPHASIZED PROTEOMICS AND LIPID OMICS WHERE WE EMPHASIZED CELL SURFACE PROTEINS AND TRANSCRIPT OMICS. THE IDEA IS TO USING THE DIFFERENT PROJECTS TO UNDERSTAND HOW TO PULL TOGETHER INFORMATION ACROSS DISEASES. FURTHERMORE, IN A NUMBER OF THESE DISEASES, THERE IS EVIDENCE FROM THE WORK BEING DONE NOW OF INFLAMMATION AND PERHAPS PATH OWE LOGIC INFLAMMATION BEING PART OF THE DISEASE PROCESS IN PLACES WE HADN'T THOUGHT ABOUT. WE INCLUDE ALZHEIMER'S AND PARKINSON'S, FOR EXAMPLE. THE IDEA IS TO USE SYSTEMS BIOLOGY APPROACH OF NOT JUST DOING THE DATA COMPARISON ACROSS THE DISEASES BUT USING THE SYSTEM'S BIOLOGY APPROACH TO DEVELOP MODELS OF HOW THE INFLAMMATORY PATHWAYS OPERATE SIMILARLY OR DIFFERENTLY ACROSS THESE DISEASES. ALL THE PROJECTS HAVE BIG DATA SETS AND WE WANT TO FOCUS ON THOSE THAT HAVE MOLECULAR DATA. TO USE THESE AS A SHARED PLATFORM FOR STARTING THE PROCESS OF DEVELOPING A WAY TO THINK OF DISEASE AT A MECHANISTIC LEVEL SO DISEASE DEFINED BY MECHANISMS NOT BY MANIFESTATIONS. THAT WOULD BE THE ULTIMATE GOAL. SO WE'LL START PROBABLY WITH AMP R.A. AND LUPUS BECAUSE WE'LL BE IN A SIMILAR PLATFORM AND ALZHEIMER'S HAS RELEVANT DATA. AMONG THE DIFFERENT APPROACHES THAT MIGHT BE MODELLING INFLAMMATION ACROSS DISEASES AND USE THE BLOOD OMICS DATA TO LINK SYSTEMIC INFLAMMATION TO STEM CELL LEVEL DISEASE AND EXPLORE THE CONTRIBUTION OF THE DISEASE OUTCOMES EVEN PLACES WHERE IT WASN'T THOUGHT TO BE PART OF THE PROCESS AND IT WILL REQUIRE THE FORMALIZED COORDINATED ANALYTIC APPROACHES AND HARMONIZED METADATA AND TOOLS AND PERHAPS ARTIFICIAL INTELLIGENCE METHODS FOR DATA MINING AND MODELLING. SO WE ENVISION A THREE-STEP APPROACH. THE FIRST WOULD BE LOW-HANGING FRUIT WHERE THERE ARE COMMON OMICS AND SIMILAR PLATFORM TO JUST SHOW THE FEASIBILITY OF WORKING ACROSS DISEASES AS I'VE DESCRIBED. THE SECOND STEP THOUGH THAT WOULD SCALE THIS UP TO INCLUDE MULTIPLE OMICS AND OTHER DISEASES AND FINALLY STEP THREE WOULD BE THE MODELLING OF INFLAMMATION I'VE DESCRIBED BUT HOPE TO START WITH DEMONSTRATION PROJECTS AND THE RELEVANT FEATURE. SO TO THIS END, THE STEERING COMMITTEE OF DIFFERENT PROJECTS MET BACK IN JUNE TO DISCUSS POSSIBLE INTERACTIONS. THEN THEY HAD A WEBINAR IN JULY AND WE BROUGHT TOGETHER THE DIFFERENT INVESTIGATORS FROM THE GROUPS AND COMPUTATIONAL LEADS FROM DIFFERENT PROJECTS. WE HEARD QUITE A FEW DIFFERENT POSSIBLE APPROACHES DESCRIBED AND QUITE A BIT OF ENTHUSIASM FOR THE CONSENT. AND OUT OF THAT WE ASKED THE PARTICIPANTS TO SUBMIT A ONE-PAGER AND THESE ARE NOW RECEIVED AND WILL BE COLLATED AND HOPEFULLY PRESENTED TO THE EXECUTIVE COMMITTEE OF THE OVERALL AMP LATER THIS MONTH. THIS WOULD FOCUS ON THE INITIAL ILLUSTRATION TYPE PROJECTS AS INITIAL GO/NO-GO, STEP ONE AND MORE TO FOLLOW THE SECOND AND THIRD STAGES SHOULD THE INITIAL EFFORT BE PERCEIVED. AND THEN OF COURSE IDENTIFYING SOURCES OF FUNDING IS AN ONGOING DISCUSSION. WITH THAT, I THINK I'M DONE. NEXT SLIDE. WE'D LIKE TO HEAR YOUR COMMENTS BOTH ABOUT THE WORKING GROUP AND THE EFFORTS ON SYSTEMIC BIOLOGY OF INFLAMMATION. THANK YOU. >> I HAVE A QUESTION, THIS IS SUSE. THIS MAY BE WAY OFF TRACK BUT IN ORDER TO GUIDE MY THINKING ABOUT THE WORKING GROUP, THIS IS SO EXCITING AND WE ALL WANT TO UNDERSTAND BETTER MODALITY AND WHAT THE TRIGGERS ARE AND HOW TO TREAT TO THOSE TRIGGERS. I'M TRYING TO FIGURE OUT WHETHER IN THIS INITIATIVE IT CROSSWALKS THE HUMAN EXPERIENCE. SO, WE UNDERSTAND AT THE CELLULAR LEVEL SOMETHING IS HAPPENING IN A PATIENT. ARE WE ALSO CAPTURING DATA, SIMULTANEOUSLY ABOUT WHAT THAT PATIENT LOOKS LIKE AND WHAT THEIR SYMPTOMOLOGY IS AND WHAT THEIR FUNCTION IS? BECAUSE I THINK THAT HAS BIG IMPLICATIONS IN A LOT OF DIRECTIONS IN HOW WE TARGET PATIENTS TO RECRUIT FOR THESE TYPES OF STUDIES AND ALSO IN HOW WE MESSAGE THE IMPORTANCE OF THIS WORK AND THEN HOW WE TRANSLATE IT AND CONTEXTUAL IZE IT FOR USE IN PRACTICE FOR CLINICIANS AND PATIENTS. DOES IT DO THAT OR IS THIS MUCH MORE -- >> YEAH. >> WE WANT TO BEAR IN MIND POTENTIAL CONFLICTS FOR POTENTIAL APPLICANTS BUT JILL HAS BEEN TREMENDOUSLY INVOLVED IN THE EFFORT AND THE IMPORTANT THING ABOUT THE DATA SET AND IN THIS CASE I WAS TOLD BY ONE OF THE ORGANIZATION S THAT THE AMP LUPUS DATA SET ON THE PATIENTS WAS THE BEST DATA SET ON PATIENTS WITH LONGITUDINAL FOLLOW-UP OF ANY SPORT. THAT CAME AS A SHOCK TO ME. AND IT'S A CONTRIBUTE TO WORK JILL DID AND OTHERS. COULD WE GO FURTHER IN TERMS OF PATIENT ENGAGEMENT? YES, WE SHOULD AND YOUR VOICE IS RIGHT BUT IN TERMS OF CAPTURING PATIENTS AND THEIR OUTCOMES, THAT WAS ONE OF THE BIGGEST EFFORTS WE MADE IN LUPUS AND THE LONGITUDINAL FOLLOW-UP IN LUPUS IS HARD. THE SUCCESS RATE WAS AROUND 80%, 85% IN TERMS OF DATA CAPTURE. IT'S NOT EASY BUT I THINK WE DO NEED TO CIRCLE BACK AND AS WE STAND UP THE NEW PROJECT MAKE SURE WE HAVE THE PATIENT VOICE MORE THAN WE DID IN R.A. AND LUPUS. IF ONLY JUST TO MAKE SURE THAT WE GET THE DATA WE NEED IN THE END TO HELP PATIENTS. >> LET ME ADD TO THAT. THE PATIENT-REPORTED OUTCOME USING THE MEASURES WAS INCLUDED AS PART OF THE LUPUS COMPONENT. THE INCLUSION OF PATIENT-REPORTED OUTCOMES AND THE USE OF THE SYSTEM THAT COULD BE USED IN PATIENTS WITH CHRONIC METABOLIC DISEASES, ALZHEIMER'S AND AUTOIMMUNE DISEASES. GO IN FOR DISCUSSION FOR THE AMP/AIM PROJECT. AND WHAT IS IN PUT IN PLACE BETWEEN AMP/AIM LUPUS IS THE PARTNERS AND THE RESEARCH ON PAIN AND INCLUSION OF THE PATIENT PERSPECTIVES IS ONE OF THOSE IMPORTANT ITEMS FOR DISCUSSION AND CONSIDERATION GIVEN THE FDA INCLUDE PATIENT PERSPECTIVES INCREASINGLY IN THE AND AMP IS GEARED TOWARDS INVENTION MAKES SENSE TO HAVE THE TWO ALIGNED AT THE BEGINNING OF THE PROJECT. I'M EXCITED ABOUT THE PROJECT. >> I HAVE TWO QUESTIONS. CAN YOU REMIND US WHAT THE MAJOR CONCLUSIONS WERE FROM THE PROJECT AND NEW DIAGNOSTICS OR THERAPEUTICS THAT CAME FROM IT AND WHAT GAPS WERE IDENTIFIED THAT REMAIN THAT WE WANT TO FILL WITH THE NEXT PHASE OF THIS AND THE SECOND QUESTION IS HOW ARE THE AMPS CHOSEN? SLE, ALZHEIMER'S DISEASE, COMMON METABOLIC DISEASES. WHAT ABOUT OTHER THE DISEASES UNDER THE NIAMS UMBRELLA LIKE OSTEOARTHRITIS AND OSTEOPOROSIS. >> YOU MAY KNOW DOUG KYLE'S DATABASE IS IN THE COMMON DISEASE PLATFORM. MARK, COULD WE GO BACK TO MAYBE SLIDE FOUR? IS THAT POSSIBLE? IT'S PHENOMENAL HOW MANY THINGS WERE DISCOVERED IN THE PROCESS. WE'VE KNOWNED T FOLLICULAR HELPERS LIKE IN THE LYMPH NODE AND SPLEEN AND HERE WE HAVE THE T PERIPHERAL HELPER LOOKS LIKE A FOLLICULAR HELPER BUT DIFFERENT IN TERMS OF THE CHEMO KINE RECEPTORS AND TYPES OF FIBROBLASTS THAT HAD NOT BEEN SEEN BEFORE DIFFERENT MONOCYTES IN THE TISSUES TO SEE INTERMEDIATES IN THE TISSUES THAT LED FROM A BLOOD TYPE OF MONOCYTE TO A KNOWN TISSUE TYPE BUT THE INTERMEDIATE ONE HAD NEVER BEEN SEEN BEFORE AND HAD ITS OWN TYPES OF ACTIVITIES THAT HAD NEVER BEEN APPRECIATED WITHIN A MONOCYTE POPULATION BEFORE. AND I DID MENTION THAT WE DO SEE SIGNIFICANT CHANGES IN THE BLOOD IN BOTH DISEASES PARTICULARLY LUPUS AND IN THE URINE THE ABILITY TO SEE ACTIVE MONOCYTES AND LOOK AT THEIR TRANSCRIPTOMICS AND ANOTHER PAPER SHOWED URINE IL16 CORRELATED WITH DISEASE ACTIVITY PRETTY WELL. YES, THERE WERE QUITE A FEW THINGS THAT WERE NEW. AND I DO THINK THIS PROJECT BECAME THE POSTER CHILD FOR HOW TO UNDERSTAND HUMAN DISEASE. THAT'S QUITE A STATEMENT, ACTUALLY. >> MY QUESTION IS, IS THIS CHANGING PRACTICE? IS THIS LEADING TO NEW DIAGNOSTIC TOOLS? >> I THINK SO. IT'S STILL A DISCOVERY PLATFORM AND MEANT TO IDENTIFY DRUG TARGETS DRUG COMPANIES AND OTHERS CAN THEN GO AFTER. IT'S MEANT TO IMPROVE THE SUCCESS RATE OF PHASE 3 TRIALS BUT LUPUS HAS HAD A COUPLE WINS LATELY WHICH IS WONDERFUL NEWS. IF YOU DON'T KNOW WHO THE PLAYERS ARE, MY PHILOSOPHY IS IF YOU DON'T KNOW WHO THE PLAYERS ARE YOU CAN'T BE EFFECTIVE IN THE DISEASE. I DO THINK THEY'LL LEAD TO NEW TREATMENTS. THE GAP IS IN THE FIRST STAGE WAS THE SPATIAL WORK. THE AREAS WHERE IN THE DIFFERENTIATION OF SOME OF THE TISSUE RESONANT CELLS, THE FIBROBLASTS THEY HAD TO DO BACK AND SHOW HOW THEY WERE INTERACTING. THAT'S GOING TO LEAD TO AS A SPECIAL APPROACH OF TREATING USING ONE OF THE NOTCH 3 LIGANDS ON THE MARKET FOR OTHER PURPOSE IDENTIFIED AS ACT VITTING THE SET OF FIBROBLASTS BUT IT WILL BE TARGETED THERAPEUTICS COMING OUT OF THIS NOT THOUGHT OF BEFORE BUT IT'S NOT THE PRIMARY GOAL. >> HOW ARE THEY CHOSEN? >> THERE'S A FORM ANYONE CAN FILL OUT AND SUBMIT. A AND OSTEOARTHRITIS HAS BEEN A MIXED PLAYER IN TERMS OF COMPETITIVE PROCESS. AND WOULD CLEARLY MEET THE TARGET AND THEN ROUNDING UP POTENTIAL FUNDING PARTNERS. YOU DON'T HAVE TO HAVE THE FUNDING PARTNERS IN PLACE BUT WILL HAVE TO HAVE A CLEAR AVENUE TO GET THERE BEFORE SUBMISSION. SO WOULD WE LIKE TO DO AN AMP IN OSTEOARTHRIT OSTEOARTHRITIS? YOU BET YOUR DOLLAR, ABSOLUTELY. WE'RE STILL DIGESTING O.E.I. BUT WE'VE HAD A LOT OF CONVERSATIONS IN WHAT WE CAN DO AND YOU'LL HEAR SOME OF THOSE WHEN WE GET TO THE CON SEPS. -- CONSENTS. >> WE'LL TAKE A COUPLE MORE QUESTIONS. >> THANK YOU. EXCUSE MY NAIVENESS NOT BEING A RESEARCHER BUT YOU STATED THE GOAL IS THE MOLECULAR PATHWAY VERSUS THE CLINICAL MANIFESTATIONS WHICH IS GREAT. THERE'S A POSSIBILITY OF GREATER AMPLIFICATION AND LESS NOISE AND GREATER FOLLOW-UP. I DON'T GET IT. >> IN PART BECAUSE OF THE INTEREST OF THE COMPANIES BUT I DON'T WANT TO PUT THE BLAME ON THEM. I AGREE AND SOME OF THE WORK IN PEDIATRIC, DERMATOLOGY SPACE IN PARTICULAR HAS THE ABILITY TO TRANSFORM SCIENCE. I'M REFERRING TO THE E.B. WORK. SOME OF THE WORK IN PEDIATRIC LUPUS HAS BEEN TREMENDOUSLY EYE OPENING AND PARADIGM SHIFTING. I AGREE WITH YOU THERE ARE THINGS TO BE LEARNED IN PEDIATRICS THAT GO BEYOND ADULT ADULTS. IN THIS CASE WE'RE TRYING TO FUT TOGETHER STRAIGHTFORWARD TO GET THROUGH THE PROCESSES WHERE WE CAN GET A LOT OF DIFFERENT PARTNERS ON BOARD AND FRANKLY THE ADULT WORK IS A LITTLE BIT EASIER BUT I AGREE WITH THEIR FUNDAMENTAL POINT THERE'S A LOT OF LESSONS TO BE LEARNED FROM PEDIATRICS WHERE THERE'S MORE SYSTEMIC MODIFICATIONS AND MORE SEVERE MANIFESTATIONS AND STRONGER LINK TO GENETICS. I WOULD AGREE ON THOSE POINTS. >> WE WANTED TO BE ABLE TO BUILD DISEASE MECHANISMS IN TISSUE AND IT'S GOING TO BE VERY DIFFICULT TO SET UP A PROGRAM WITH BIOPSIES AND IN CHILDREN WITH JUVENILE ARTHRITIS AND THAT'S ONE OF THE MAIN REASONS. >> I THINK MARY HAD HER AND UP AND THEN ELIZABETH. >> I HAD AN OFFLINE CONVERSATION WHETHER ALL THE OMICS DATA ARE PUBLICLY AVAILABLE LIKE IN DB GAP AND HEARD THEY AND WANT TO EMPHASIZE THAT SEEMS IMPORTANT SINCE NEW ANALYTICS ARE INVOLVED ALL THE TIME AND MAKE SURE PEOPLE IN THE ORIGINAL STUDIES TO EXPLORE THE DATA SETS IS KEY. >> AND WENT INTO THE NIAID PLATFORM AND TURNED OUT TO BE ONE OF THE MOST FREQUENTLY ACCESSED DATA SITE. >> AND THAT INTRODUCES THE NEXT TOPIC BUT BEFORE WE GO THERE, WE HAVE A HAND UP. >> THANK YOU. IT'S A GREAT SUMMARY OF THE AMP PROJECT AND I'M EXCITE ABOUT THE FUTURE PROJECT THAT'S COMING ALONG. MY QUESTION IS HAS THE PROJECT REACHED A POINT WHERE IMPORTANT GENES ARE IDENTIFIED IN THE CHANGE IN THE PATIENTS THAT WE COULD START USING FOR EXAMPLE THE NEW GENE EDITING APPROACH LIKE CRISPR CAS WITH CELL APPROACH AS A MODEL TO TRY TO CORRECT THESE IMPORTANT GENES THAT ARE MUTATED IN THE PATIENTS? >> SO THESE ARE VERY POLY GENIC DISEASES. BUT WE DO COLLECT THE DNA I THINK AS THE A CHIP-BASED ASSAY FOR SNIPS. THE SYSTEMS BIOLOGY GROUP HASN'T REALLY GOTTEN THERE YET BUT THE BACKGROUND IS IN GENETICSES -- GENETICS AND IN OTHER STUDIES WHERE PEOPLE HAVE TAKEN HEALTHY PEOPLE WITH DIFFERENT ALLELES OF THE RISK GENES FOR THESE AND IF YOU LOOK AT THE DIRECT CELLS THE IMPACT OF THOSE IS ACTUALLY PRETTY DRAMATIC. IT'S NOT SUBJECT AT SHIFTS IF YOU LOOK IN THE RIGHT PLACE. SO WE HAVEN'T GOTTEN THERE YET BUT ONE OF THE REASONS I WENT INTO THE PROJECT IN THE FIRST PLACE EIGHT YEARS AGO WAS TO UNDERSTAND HOW SNIPS PLAYED OUT IN DIFFERENT TRANSCRIPTOMICS IN THE TISSUE AND HOPE TO GET THERE BUT THE WORK HASN'T BEEN DONE YET. AND QUICKLY THE SECOND PART IS THAT WE NEED TO DO SOME WORK FOR TARGET VALIDATION. THAT'S WHERE THE CRISPR TYPE ASSAYS WILL COME INTO PLAY. THOSE ARE NOT FUNDED AS PART OF THIS WORK IN ITSELF. >> GREAT QUESTION AND THANKS FOR THAT RESPONSE. WHY DON'T WE MOVE TO THE NEXT SECTION ON DATA SCIENCE WHICH IS RELEVANT TO THIS. IF YOU CAN GET TO THE NEXT SLIDE. SO THANK YOU. SO NEEDLESS TO SAY, THE INCREASING AVAILABILITY OF LARGE DATA SETS COMBINED WITH NEW TOOLS FOR DATA STORAGE AND ANALYSIS PROVIDE ENORMOUS OPPORTUNITIES TO GAIN INSIGHT FROM EVERYTHING TO MOLECULAR PATHWAYS TO POPULATION SCIENCE. HOWEVER, THE DATA SETS NEED TO BE BROADLY AVAILABLE AND USABLE TO HAVE THE GREATEST IMPACT AND THE NIH HAS DATA SHARING REQUIREMENTS MANY HEARD ABOUT AT THE FEBRUARY 2020 MEETING. FROM THE INSTITUTE'S PERSPECTIVE, MAINTAINING LARGE DATA SETS, MAKING THEM ACCESSIBLE AND PROVIDING THE ANALYTIC TOOLS CAN BE EXPENSIVE AND TECHNOLOGIES ARE CHANGING RAPIDLY AS JUST POINTED OUT. ON THE OTHER HAND, FROM THE PERSPECTIVE OF THE INDIVIDUAL RESEARCHER, REQUIREMENTS FOR DATA SHARING RING ADDITIONAL BURDENS. SO IF YOU CAN MOVE TO THE NEXT SLIDE. NIAMS IS REVIEWING THE APPROACH TO DATA SCIENCE AND THE NEW REQUIREMENTS AND TO THIS END WE DECIDED ON THE TWO-PRONG STRATEGY. WE ALREADY LAUNCHED AN INTERNAL GROUP CHARGED WITH DEVELOPING A SET OF ACTIONS AND IMPLEMENTING SOLUTIONS. WE ALSO PLAN TO STAND UP A WORKING GROUP OF COUNCIL TO BRING THE PERSPECTIVE OF THE EXTRAMURAL RESEARCH COMMUNITY TO HELP PROVIDE GUIDANCE AND INSIGHT REPORTING BACK TO YOU, MEMBERS OF COUNCIL. I WANT TO THANK BOB FOR LEADING THE PLANNING AND IMPLEMENT GROUP HE'LL INTRODUCE AND WOULD LIKE TO THANK DR. SEUSS -- DR. SUSANA SERRATE-SZTEIN AND SHE'LL INTRODUCE A SET OF TOPICS AND THIS WILL HELP THE WORKING GROUP WHEN IT LAUCHES. BOB WILL LEAD WITH THE IMPLEMENTAL PLANNING GROUP AND SUSANA WILL HAVE MORE ON THE WORKING GROUP AND THEN TO DISCUSSION. NOW BACK TO BOB. >> THANK YOU. THIS GROUP HAS TWO TASKS. THE FIRST WAS TO THINK ABOUT HOW WE'RE GOING TO EVEN GO ABOUT THIS TYPE OF SURVEY OF BOTH THE INTERNAL DATA NEEDS AND THE DATA NEEDS OF THE COMMUNITY AND THE NEEDS RELATED TO DATA SHARING. THE FIRST THING WE HAVE IS A PLANNING PHASE. IN THAT PHASE WE DISCUSSED FOR STARTERS, WHAT THE WORKING GROUP OF COUNCIL WOULD BE ASKED TO DO. WHAT WOULD BE THEIR FOCUS AND AS LINDSEY DESCRIBED, WHAT WOULD BE THEIR CHARGE. THIS GROUP ALSO STARTED TO LOOK AT INTERNAL DATA NEEDS AND TOOLS AVAILABLE AT NIAMS OR NIMH INCLUDING DATA SETS AND INFRASTRUCTURE AND TOOLS AND LOOKING FOR WAYS THAT THE IRP, THE INTRAMURAL RESEARCH PROGRAM THAT CREATES DATA AND MANAGING DATA AND WHERE NEEDS AND CONCERNS WOULD BE SHARED AND POSSIBLY USE FOR COMMON SOLUTION ALL IN THE SETTING OF MAKING SURE WE'RE USING CYBER SECURITY AND LOOK AT THE TOOLS AVAILABLE ACROSS NIH AND THE DIFFERENT OPPORTUNITIES THAT KEEP FLOATING UP WE NEED TO DO A BETTER JOB OF TRACKING HOW TO SUPPLEMENT DATA SCIENCE TYPE WORK WHETHER TRAINING OR A DATA MANAGEMENT PILOT PROJECT WHERE ALL THE DATA FROM ONE LAB WILL BE FUNNELED THROUGH ONE DATA MANAGEMENT SYSTEM AS A WAY OF SEEING BOTH THE STRENGTHS AND CHALLENGES INVOLVED IN DATA MANAGEMENT ON THE IRP SIDE WITH NEWER TOOLS. THE PLANNING PHASE HAS LARGELY BEEN COMPLETED AND AS THE DIFFERENT GROUPS MENTIONED IN PARTICULARLY AS THE WORKING GROUP COUNCIL DOES ITS WORK, THIS GROUP WILL BE RATHER IN THE BACKGROUND. ONCE THE WORKING GROUP AND OTHER ACTIVI ACTIVITIES I MENTIONED COME ONLINE THIS GROUP WILL COME BACK UP AND LOOK AT HOW INTEGRATION OF EFFORTS ACROSS THE IRP AND EXTRAMURAL PROGRAM I MENTIONED AND HOW TO INTEGRATE THOSE WITH THE TRANS-NIH DATA RESOURCES AND TAKE THE RECOMMENDATIONS FROM COUNCIL IN LOOKING AT HOW WE CAN APPLY TO LESSONS YOU ALL HAVE LEARNED FROM THE EXTRAMURAL SIDE TO WHAT WE NEED TO DO AT NIH TO PRIORITIZE SOME OF THE RECOMMENDATIONS THAT COME FROM THE WORKING GROUP TO MAKE SURE WE CAN DO SOME OF THOSE RECOMMENDATIONS WITHIN THE EXISTING BUDGET AND PROVIDE OVERSIGHT FOR THE ACTUAL IMPLEMENTATION OF THOSE DIFFERENT ACTIVITIES AND DATA STORAGE REQUIREMENTS AND TOOLS THAT I MENTIONED. SO THAT IS ALL TO COME. FUTURE AND LARGELY BASED ON THE WORK OF THE WORKING GROUP SUE SAN -- SUSANNA WILL TALK ABOUT. >> THANK YOU FOR TALKING ABOUT THE STRATEGIES FOR THE NIAMS DATA SCIENCE INVESTMENT AND FUTURE OPPORTUNITIES. TODAY IN THE NEXT SLIDE, I'LL DISCUSS THE WAYS THE DATA SCIENCE STRATEGY OCCUR AND ACTIVES IN THE DEVELOPMENT OF THE NIH STRATEGIC PLAN FOR DATA SCIENCE AND REQUIREMENTS FOR THE INVESTIGATORS TO CONDUCT RESEARCH IN TERMS OF DATA MANAGEMENT AND POLICY. I WILL THEN MOVE ON TO THE CHARGE TO THE WORKING GROUP OF COUNCIL AND DISCUSS SOME DETAILS REGARDING THE LOGISTICS IN TERMS OF WHAT WE ANTICIPATE THE WORK OF THE WORKING GROUP WILL BE. THE TIME LINE AND THEN BACK TO A MODERATED DISCUSSION. SE THE NIH IN ADDRESSING THE CHALLENGES OF DATA SCIENCE FOR MANY YEARS AND THE EFFORT CULMINATED IN THE NIH DATA SCIENCE STRATEGIC PLAN BACK IN 2018. THE PLAN ADVISED BY COUNCIL PROPOSED BY MANY LEADERS AT NIH AND LED TO THE CREATION OF THE OFFICE OF DATA SCIENCE STRATEGY. YOU CAN SEE AT THE BOTTOM OF THE SLIDE GOING TO THE ODSS WEBSITE TO LOOK AT THE MILLION THE PLAN IS A DYNAMIC DOCUMENT ORGANIZED AROUND A NUMBER OF SCIENCE THEMES RANGING FROM INFRASTRUCTURE TO COMMUNITY -- [BACKGROUND NOISE] AND BASED ON THE NOTION THE MISSION OF NIH IS ADVANCED BY AN INVESTMENT AND FOCUS ON DATA SCIENCE BECAUSE IT ALLOWS THE ADVANCEMENT AND INNOVATION OF PERSONALIZED MEDICINE. AND DELINEATES OBJECTIVES NIH BEGAN TO IMPLEMENT PRIMARILY THROUGH THE ODDS OFFICE AS MENTIONED BEFORE, DR. GREGORY THE DIRECTOR OF THE OFFICE AND CREATING INFRASTRUCTURE RESOURCES FOR DATA SCIENCE AS WE SAID ALL NIH FUNDED INVESTIGATORS. IN ADDITION, THE HEAD OFFICE HAS MET THE NUMBER OF FUNDING OPPORTUNITY ANNOUNCEMENTS AND I SHOULD ACKNOWLEDGE OUR COLLEGIATE THIS POINT WHO HAS BEEN THE NIAMS REPRESENTATIVE TO MANY OF THE WORKING GROUPS AND TEAMS THAT HAVE BEEN WORKING WITH THE ODSS TO CREATE SOME OF THESE FUNDING OPPORTUNITIES. THEY ARE NOT MENTIONED IN THE SLIDE THAT ARE PROGRAM ANNOUNCEMENTS, P.A.R.s THAT CREATE KNOWLEDGE BASES FOR THE SUPPORT OF DATA SCIENCE. THERE'S A SECOND PROGRAM OF INITIATIVES TO EXISTING GRANTS FOUR OF WHICH IN THE SLIDE. I WILL NOT GO IN DETAIL INTO THOSE BUT THEY'RE SPONSORED BY ODSS AND MANY INSTITUTES AND CENTERS AROUND NIH. AND I SPANS THROUGH FISCAL YEAR 2020, 2021 AND 2022 SO THAT OUR APPLICATIONS THAT ARE IN THE SYSTEM. THE NIMS IS EXPECTED TO PARTICIPATE IN TWO OF THESE AT THE UPCOMING COUNCIL MEETING IT WILL BE INTERESTING TO SEE THE RESULTS OF SOME OF THE APPLICATIONS BUT SO FAR THE INSTITUTION HAS BEEN BRIEFED WITH THE SUCCESS OF APPLICATIONS FOR SUPPLEMENT TO EXISTING GRANTS AND THE IDEA OF DEVELOPMENT TOOLS AND IN WORKFORCE DEVELOPMENT. IN ADDITION TO CREATING SOME RESOURCES TO IMPLEMENT THE NIH DATA SCIENCE STRATEGIC PLAN, THE NIH HAS ISSUED RECENTLY POLICY THAT REPLACE THE OLD POLICY IN DATA SHARING AS A WAY OF FOSTERING A CULTURE LEADING TOWARDS OPEN SCIENCE WHERE FAIR PRINCIPLES CAN BE APPLIED MORE WIDELY. SO THE NEW POLICY REQUIRES THE DEVELOPMENT AND INCLUSION IN APPLICATIONS WITH A PLAN FOR DATA MANAGEMENT AND SHARING. I SHOULD EMPHASIZE THIS IS WHAT INCLUSION OF THE PLAN THE HOW, WHAT, WHEN AND WHERE OF DATA SHARING AND THERE'S A GOOD DEFINITION OF WHAT DATA ARE TO BE INCLUDED AND THE POLICY AND YOU CAN SEE HERE ON THE SLIDE APPLICATIONS AND PROJECTS AFTER JANUARY 25, 2023. IN ADDITION TO THE NOTICE DESCRIBING THE POLICY, THERE'S THREE OTHER LINKED NOTICES AND I ENCOURAGE YOU TO SPEND TIME LOOKING AT THE NOTICES. THE LINKED NOTICED, O.D.21014, 15 AND 16 DESCRIBE COMPONENTS OF THE DATA MANAGEMENT AND SHARING AND CONSIDERATION WHAT'S BUDGET ALLOWANCES OR CATEGORIES OR COSTS COULD BE INCLUDED AS PART OF THE APPLICATIONS. AND WE CAN COMMENT ON THE BUDGET REQUEST RELATED TO THE DATA MANAGEMENT AND SHARING. YOU CAN SEE HERE THE PLAN THEY'RE RECOMMENDED IT INCLUDE THE DATA TYPES AND THERE'S MANY TYPES OF DATA THAT ARE USED TO PRODUCE PUBLICATIONS AND REPORTS. THE SECOND EXPECTATION IS THE DATA INCLUDES NOT ONLY THE DATA USED BUT ANY DATA THAT MEETS THE DEFINITION OF THE DATA SETS HERE IN THE POLICY THAT WILL REDUCE FUND FROM NIH WHETHER APPLICATION OR NOT SO IT'S IMPORTANT CONSIDERATION. AND IT INCLUDES DETAILS ON THE TOOLS, SOFTWARE AND CODE AND WHAT APPROACHES ARE PLANNED FOR DATA PRESERVATION ACCESS. WHAT ARE PLANS FOR DISTRIBUTION OF THE DATA AND WHAT THE INVESTIGATORS HAVE IN TERMS OF HOW THEY ANNOTATE ORGANIZED STRUCTURE IN THE DEPOSITORIES AND KNOWLEDGE BASES THEY USE THE DATA WITH IN TERMS OF DISABILITY. THIS IS A VERY IMPORTANT CHALLENGE I HOPE WE CAN ADDRESS LATER AT THE END OF THE DISCUSSION. THE POLICIES IN LINE WITH OTHER POLICIES REGARDING DATA SHARING AND GENOMIC DATA SHARING POLICY. NEXT SLIDE, PLEASE. >> JUST A REMINDER FOR THOSE OF YOU NOT PRESENTING SHOULD MUTE. >> THANK YOU. SO JUST TO LET YOU KNOW, PROGRAM OFFICERS WILL BE ASSESSING THE PLANS AND APPLICATIONS AND IT'S A VERY SIGNIFICANT EFFORT AROUND NIH TO PRODUCE GUIDANCE AND TRAINING FOR THE PROGRAM STAFF SO THE POLICY AND ASSESSMENTS COULD BE DONE CONSISTENTLY FROM INSTITUTE TO INSTITUTE. AND COMPLIANCE WITH THE PLAN WILL ALSO BE MONITORED YEARLY BY THE PROGRAM STAFF. SO HOW IS NIAMS GOING TO APPROACH THIS? THERE'S POLICY AND AN APPLICATION OF THE DATA SCIENCE THE PRINCIPLES FOR DATA SCIENCE. AND ALSO THE INCREASING TREND TO OPEN SCIENCE ENVIRONMENT IN WHICH DATA SETS AND INVESTIGATORS AND TEAMS ARE SHARED IN REAL TIME. WE HOPE IT WILL HELP US THINK OF ISSUES THAT AFFECT DATA SHARING IN ORDER TO DO THAT, OUR PLAN IS TO CONVENE A WORKING GROUP OF COUNCIL EXPOSED -- COMPOSED OF A MEMBER GROUP OF COUNCILS FROM REPRESENTATIVES AND FROM THE OFFICE OF DATA SCIENCE STRATEGY AND ONE REPRESENTATIVE FROM ANOTHER INSTITUTE THAT IS ALSO INVOLVED IN THE DEVELOPMENT OF DATA SCIENCE STRATEGY AS WELL AS A REPRESENTATIVE FROM THE EXTRAMURAL RESEARCH DIVISION OF THE NIAMS. IN ADDITION, WE PLAN TO BRING ADDITIONAL EXPERTISE FROM THE SCIENTIFIC COMMUNITY INCLUDING SYSTEMS BIOLOGY AND IMPLEMENT SO WE CAN HAVE DISCUSSION ABOUT THE ISSUES THAT ARE RELEVANT. THIS DESCRIBES THE TWO MAIN AREAS TO FORM THE BASIS OF THE CHARGE TO THE WORKING GROUP WE ARE PROMOTING. WE THINK THE WORKING GROUP IS IB A UNIQUE POSITION TO PROVIDE THE COUNCIL AND INSTITUTE WITH GENERAL GUIDANCE ABOUT THE DATA SCIENCE THAT COULD BE CRUCIAL TO ADVANCE THE RESEARCH MISSION OF THE INSTITUTE. AND THE REQUIREMENTS OF INVESTIGATORS ARE COMING UP QUICKLY, WE ARE HOPING THE WORKING GROUP WILL THEY CAN REFER THEM TO THE GROUP AND BEGIN IMPLEMENTING SOME OF THOSE UNDER THE SHORT TERM. THE NEXT SLIDE, THESE ARE SOME OF THE CRITICAL YARZ AREAS FOR THE WORKING GROUP TO CONSIDER AND TRYING TO ALIGN THOSE WITH THE SCIENTIFIC THEMES AND THE NIH PLAN IS INFORMING A NUMBER OF DECISIONS NIH IS MAKING ABOUT RESOURCE AND HOPE IN RECOMMENDATIONS THE WORKING GROUP CAN TAKE ADVANTAGE OF LEVERAGING SOME OF THOSE OPPORTUNITIES AS MENTIONED EARLIER. ALSO BECAUSE WE THINK IN ADDITION TO THE SCIENTISTS FUNDED AND SUPPORT THE NIAMS, AND FUNDED BY RICs AND WOULD LIKE TO REMAIN IN SYNC. YOU CAN SEE HERE WHAT WE THINK IS IMPORTANT FOR THE WORKING GROUP TO CONSIDER PRIMARILY OR INITIALLY THE NEEDS OF INVESTIGATORS TO LOOK AT THE RESOURCES THAT MAY TAKE TIME AND CONSIDER FOR USING AND UTILIZING HIGH VOLUME DATA SETS AND WHAT ARE THE NEEDS OF THE COMMUNITY AND MOST INFORMATIVE DATA SETS THAT COULD BE MADE AVAILABLE IN THE PROCESS. WHAT KIND OF INFRASTRUCTURE WITH KNOWLEDGE BASES AND CYBER SECURITY ISSUES SHOULD WE CONSIDER AND DATA INTEROPERABILITY A BIG ISSUE AND REQUIRES THE EXPERTISE THAT WILL BE REPRESENTED AROUND THE TABLE WHEN THE WORKING GROUP MEETS BECAUSE ISSUES OF OPERABILITY ARE CLOSEST RELATED TO THE SCOPE AND CONTENTS OF THE SCIENCE IS INCLUDED IN THE DATA SETS. WE WOULD EXPECT TO TO ADDRESS ISSUES OF INTEROPERABILITY OF DATA SETS AND INVESTIGATORS AND ETCETERA. FOR THAT WE NEED TO BUILD EXPERTISE. AND HOW SHOULD WE THINK WITH THE ISSUES THAT COULD MOVE THE CULTURE WITH THIS GOOD AND LOFTY GOALS. AND KEEL WITH TRAINING AND SCIENTIFIC OPPORTUNITIES TO ADVANCE OUR SCIENCE THROUGH RESEARCH USING ARTIFICIAL INTELLIGENCE AND HOW TO LEVERAGE RESOURCES WITH NIH AND PARTNER ORGANIZATIONS INCLUDING SOME CREATING THEIR OWN KNOWLEDGE BASES AND DATA PORTALS AND WHAT HAS BEEN LEARNED FROM INSTITUTIONS WE REPRESENT WE COULD USING TO MAKE OUR PLAN AND STRATEGY MORE EFFECTIVE. WITH THAT I WILL -- THIS IS OUR TIME LINE. SORRY. A LITTLE BIT AMBITIOUS. WE HOPE THE WORKING GROUP WILL MEET MONTH LY AND THERE'S MEETINGS IN OCTOBER. OUR HOPE IS THAT A REPORT WILL BE PRODIVED A-- PRODUCED AND PRESENTED IN JUNE 2022. AS MENTIONED, WE ARE ENGAGING WITH EXERCISES AND THINK THE WORKING GROUP PLAYS A ROLE IN THE DESIGN PROCESS. I WOULD LIKE TO TURN IT OVER TO DR. CRISWELL TO MODERATE THE DISCUSSION AND BEFORE I DO THAT I WANT TO ACKNOWLEDGE MY COLLEAGUE WHO HAS AGREED TO WORK WITH ME AND WE'LL KEEP IT ON TIME. THANK YOU >> THANK YOU FOR INTRODUCING THE TOPIC AND FOR PUTTING US BACK IN GALLERY VIEW. A BIG TOPIC IS ONE THAT ALREADY CAME UP IN PREVIOUS DISCUSSIONS AND LEADING UP TO TODAY. YOU HEARD A LOT OF INFORMATION BUT WE'D LOVE TO HEAR YOUR REACTIONS, THOUGHTS, SUGGESTIONS, QUESTIONS I SEE ONE HAND UP. >> IT'S SO IMPORTANT AND THANK YOU FOR EMPHASIZING THE IMPORTANT AREA AND ONE THAT AFFECTS EVERYBODY AT THE NIH, WHAT WAYS ARE YOU GUYS IMAGINING FOCUSSING THE DISCUSSION ON NIAMS PARTICULAR NEEDS AND AT THE SAME TIME LEVERAGING AND LEARNING ALREADY FROM WHAT IS HAPPENING ACROSS THE NATION. AND THE NATIONAL INSTITUTE OF MEDICINE AND THE WHOLE INSTITUTE FOCUSSING ON THAT AND NIAMS. >> WE HAVE TO BE EFFICIENT AND LEVERAGE RESOURCING, PLANNING, INFRASTRUCTURE AVAILABLE. NOT EASY TO DO THAT BUT THE IMPORTANCE HAS BEEN FACTORED IN THE STRUCTURE OF THE WORKING GROUP OF COUNCIL WHICH WILL HAVE A MEMBER FROM ODSS. SEVERAL OF US INTERACT WITH THE OFFICE OF STRATEGY AND I'LL MEET WITH THAT OFFICE AND WE HAVE CLOSE CONNECTIONS AND SEVERAL MEMBERS OF THE NIAMS TEAM ALREADY INTERSECTS WITH SOME OF THOSE EFFORTS. IT'S A LOT FOR US TO WRAP OUR HEADS AROUND BUT CRITICALLY IMPORTANT AND WE'RE LOOKING TO YOU AND THE NIAMS COMMUNITY TO HELP US UNDERSTAND SPECIFICALLY FOR THE NIAMS DISEASE AREAS WHERE THE MOST IMPORTANT OPPORTUNITIES ARE BUT I WELCOME COMMENTS AND QUESTIONS ON THE TOPIC. >> WE NEED TO UNDERSTAND HOW WE ARE ADDRESSING AND WHAT THEY ARE CREATING TO ADDRESS THE DATA SCIENCE OPPORTUNITIES AND POLICIES. IN ADDITION TO WHAT THEY'RE DOING FOR THE EXTRAMURAL COMMUNITY AND LOOKING FOR THE INTRAMURAL INVESTIGATORS AND ACKNOWLEDGE HERE THE CONTRIBUTIONS OF OUR CHIEF INFORMATION OFFICER WHO IS WORKING WITH COLLEAGUES TO CREATE THE INFRASTRUCTURE WE SUPPORT THE DATA STORAGE NEEDS AND DATA SHARING NEEDS OF INTRAMURAL INVESTIGATORS AND PARTNERS. YOU WILL HAVE THE WORKING GROUP WILL HAVE AN OPPORTUNITY TO HEAR DIRECTLY ABOUT ALL THOSE OTHER ACTIVITIES. >> DO YOU WANT TO RESPOND BEFORE WE MOVE ON TO OTHER QUESTIONS? >> NO, I JUST FIGURED THIS IS A DISCUSSION RELATIVE TO MY AREA OF EXPERTISE I'LL BE AVAILABLE FOR COMMENTS BUT DIDN'T HAVE A SPECIFIC ONE ON THIS TOPIC. >> THANK YOU. THE NEXT HAND WAS JENNIFER'S. >> I'LL JUMP IN. >> I HAVE A COLLEAGUE THAT SERVES ON A STUDY SECTION ON DATA SCIENCE AND TALKS ABOUT HOW THERE'S TWO, I GUESS, PLACES WHERE REVIEWERS COME FROM. ONE IS ON QUALITY OF THE DATA. NONE OF THIS WORKS IF THE DATA ISN'T GOOD SO DATA QUALITY HAS TO BE THE FOUNDATION FOR THIS. GARBAGE IN, GARBAGE OUT. ONE FOCUSES ON HOW YOU COLLECT THE DATA, HOW DO YOU ENSURE CONTROL OF THE DATA AND SO ON AND THE OTHER MIND SET IS JUST DEVELOPING NEW TOOLS TO ANALYZE IT. WE DON'T CARE WHAT THE DATA ARE. JUST DEVELOP NEW TOOLS. IS THERE A WAY TO HAVE A COMMON DATA SET SO THERE'S WAYS TO COMPARE THINGS? A DATA SET THE COMMUNITY UNDERSTANDS, THE COMMUNITY ACCEPTS AND SO ON. I THINK THESE WILL TWO DIFFERENT CAMPS IN THIS FIELD. LET'S FOCUS ON WHERE THE DATA COMES AND THE QUALITY VERSUS LET'S JUST DEVELOP NEW TOOLS. I GUESS IT'S MORE OF A COMMENT THAN A QUESTION. >> IMPORTANT ISSUES AND TOUGH TO BALANCE. I'M SURE MANY PEOPLE ON THE COUNCIL HAVE EXPERIENCED THIS BALANCE BETWEEN COMMON DATA ELEMENTS BUT NOT LOSING THE REALLY IMPORTANT INFORMATION THAT MAY BE SPECIFIC TO A PARTICULAR CONDITION AND THEN THERE'S ALSO THE QUESTION OF WHAT DATA HAVE BEEN DEN -- GENERATE AND AVAILABLE. THIS IS NOT AN EASY TASK. THESE ARE TOUGH QUESTIONS BUT REALLY IMPORTANT. WE HAVE A COUPLE REALLY GREAT QUESTIONS. THANK YOU FOR THROWING THOSE OUT THERE. AND THEN TONY. >> YES, THANKS SO MUCH. I WOULD HAVE QUICK POINTS. FIRST, SUSAN GREGURICK'S PRESENTATION TO THE COUNCIL A COUPLE YEARS AGO WAS MIND CHANGING FOR ME WITH DATA INTEROPERABILITY AND SHARING. THE SECOND POINT IS I THINK THE GOAL IS TO MODEL ALREADY EXISTING DATA BANKS IN OUR COUNTRY LIKE U.K. BIO BANK AND THE HUMAN CELL ATLAS AND ALSO THE LIBRARY OF MEDICINE. WE HAVE TO BE CAREFUL HOW WE DO THAT BUT THE QUESTION I HAD IS FOR BOB WHICH IS YOU JUST TOLD US ABOUT AMAZING PROGRAMS OF AMP AMP ALZHEIMER'S AND AMP FOR LUPUS. THESE ARE WHAT WE'D LIKE ACROSS THE PROGRAMS AND HOW DO YOU SEE IT GOING FORWARD IN TERM OF SHARING YOUR DATA OR APPLYING BASIC PRINCIPLES ACROSS NIAMS AND WHAT DO YOU THINK ABOUT THAT, BOB? >> THE NUMBER OF DIFFERENT ANGLES IN WHICH YOU JUST ASKED. THE FIRST WOULD BE TO SAY THAT THE TENDENCY AT NIH IS TO BUILD AND BESPOKE DATA SETS AND TO THINK ABOUT INTEROPERABILITY LATER AND THAT'S THE MIND SET THAT HAS TO CHANGE. YOU CAN'T KEEP DOING THAT. YET WE KEEP DOING IT INCLUDING IN AMP. SO IT'S A PET PEEVE AND JUST THE WAY NIH AS A CORPORATE ENTITY HAS GOTTEN UP FRONT THE WAY THE NEED TO AND IN PART THAT'S THE STRUCTURE OF BUILDING IT THE WAY THEY WANT TO AND WORRY ABOUT INTEROPERABILITY LATER. THE SECOND PART, THE THING ABOUT AMP IS THAT I DON'T REMEMBER THE EXACT LANGUAGE IN THE FOA BUT WE DO MAKE CLEAR THAT IF YOU FUNDED THE WORK WITH AMP, DATA SHARING IS ACTUALLY THE GOAL OF THE PROJECT. IT'S NOT JUST LIKE TELL US WHAT YOUR PLAN IS. THIS IS -- THAT'S WHY YOU'RE DOING THIS WORK IS TO PRODUCE A DATA SET THAT ANYBODY CAN ACCESS. THAT'S NOT GOING TO BE APPROPRIATE IN ALL CIRCUMSTANCES BUT I THINK NOW WITH THE NEW DATA SHARING POLICY, IT STARTS TO WALK UP TO THAT APPROACH. I'M NOT SURE IF I ANSWERED YOUR QUESTION, TONY. >> DO YOU THINK THE INSTITUTE IN GENERAL CAN HAVE A GUILDED, GARDEN TOP DOWN, THIS IS THE TYPE OF WHAT WE NEED FOR ENFORCEMENT WHICH IS SO AGAINST THE TYPICAL NIH POLICY? BECAUSE THAT'S WHERE U.K. BIO BANK IS KILLING US BECAUSE THEY HAVE DATA INTEROPERABILITY UP FRONT BEFORE YOU MAKE THE DATA. >> ALL OF THIS IS THE COMPARATOR TO USE ALL OF US. WHAT YOU ADDRESSED IS THE GOAL OF THE WORKING GROUP. >> IT'S SIGNIFICANT CHALLENGE. THERE'S NO DOUBT INVESTIGATORS WANT TO SHARE THE DATA AND COMPLY WITH THE DATA AND POLICY OF THE DATA. WHAT CHANGES DO INVESTIGATORS NEED IT MAKE TO MAKE THEM INTEROPERABLE. THAT COULD BE A GREAT CHALLENGE. COMMON DATA IS ONE ASPECT BUT THERE ARE OTHERS REGARDING PROMINENCE AND ETCETERA THAT WE HAVE TO CONSIDER. AND THE REQUIREMENTS AND DATA COMING FROM THE RO1s. I HOPE TO SOME EXTENT WE'LL BE ABLE TO AN ADDITION TO DATA PROCESSING AND HAVE ANNOTATION OF DATA SETS. ONE INTERESTING THING ARE LUPUS AND SOME OF THE TOOLS AND THERE'S A CONSENT WITH THE CLINICIANS AND PEOPLE WORKING ON THE BENCH TO INCLUDE AND CREATING DATA SETS. IT EXPANDS TOWARDS THE DATA SETS GENERATED. I DON'T KNOW. >> I'M SORRY IF I CAN JUMP BACK IN BEFORE WE GO, IT'S POSSIBLE, I THINK AND THERE'S A LARGE DATA SET ON THE GENETICS BONE WHICH NOW MIGRATED TO THE COMMON METABOLIC DISEASE AMP PLATFORM. SO THESE KIND OF WAYS OF MAKING THE DATA INTO A COMMON PLATFORM AND SHARING CAN HAPPEN. >> SO THANK YOU, SUE. YOU'VE HAD YOUR HAND UP FOR A WHILE SO LET'S GIVE YOU AN OPPORTUNITY TO ASK OR MAKE COMMENTS. HAVE TWO COMMENTS/QUESTIONS. THE FIRST IS ABOUT ONE OF THE QUESTIONS ON THE SLIDE WAS WHERE DO WE GO TO FOR HIGH VALUE DATA SETS. INCREASINGLY IT'S SO IMPORTANT TO TRY TO CAPTURE I'M GOING USE THE WORD PURE. PURE PATIENT GENERATED HEALTH DATA AND I'M SPEAKING MUCH MORE EXPANSIVELY THAN P.R.O.s. THEY CAN BE VALUABLE BUT IT DOESN'T ALWAYS EQUAL PATIENT IMPORTANCE SO HOW ARE WE CAPTURING THE ENTIRE GAMUT OF INFORMATION THAT'S RELEVANT AND ADDS COMPLEXITY TO INTEROPERABILITY AND OTHERS BUT WE KNOW IT'S IMPORTANT AND THAT'S ONE PIECE THAT IS IMPORTANT TO THINK ABOUT. THE OTHER PIECE IS SIMILAR AND THIS RELATES TO THE JUNK IN, JUNK OUT MANTRA. I HAVE TO BE CAREFUL HOW MUCH I SAY BUT I'VE BEEN WORKING WITH M.I.T. WITH A PROJECT ON SEVERAL YEARS NOW AND WORKING ON PUBLISHING FINDINGS ABOUT HOW INCREDIBLY IMPORTANT IT IS TO HAVE PATIENTS AND CLINICIANS BUT PATIENT THE RARE SUSPECT IN THE ROOM WHEN YOU'RE ANALYZING DATA. EVEN PATIENT GENERATED DATA. IN THIS CASE IT WAS PARTICULARLY AROUND CLAIMS IN THE M.R. DATA. WE FOUND SEVERAL AREAS WHERE THE INFORMATICISTS DREW CONCLUSIONS FROM DATA ONCE THEY PRESENTED TO US AS A PATIENT PANEL WE DEBUNKED ENTIRELY. ONE EXAMPLE IS STOPPING, STARTING, STOPPING, STARTING THERAP. THEY FIRST THOUGHT DOES THIS MEAN THERE'S A DEFECT IN THE DATA OR SOMETHING WRONG WITH THE DATA SET AND THEN IT WAS IT WASN'T EFFECTIVE AND WE SAID STOPPING AND STARTING THERAPY COULD BE A COLD, INFECTION, SURGERY, INSURANCE. THERE'S A MILLION REASONS. WHAT THAT DID WAS OPENED THE HOOD FOR A LOT OF ANALYSIS. HOW OFTEN IS DATA BEING EXPLORED, ANALYZED WITHOUT RELEVANT PEOPLE IN THE ROOM? YOU SO WHEN WE THINK OF MAKING THIS AS RIGOROUS AND VALID AS POSSIBLE, I THINK THAT NECESSARY HAS TO BE A PART. YOU HAVE TO HAVE RELEVANT STAKEHOLDERS AND COMMUNITY ENGAGEMENT WAS THERE. I'M GOING TO READ INTO COMMUNITY ENGAGEMENT AND COMMUNITY AND FAMILY ENGAGEMENT. THAT COULD BE A REALLY GREAT OPPORTUNITY FOR NIAMS TO BE OUT FRONT. THAT'S SOMETHING I WOULD SAY EVEN FDA -- THEY'VE TACKLED PATIENT EXPERIENCE DATA BUT NOT THE CONSENT YOU NEED HUMAN PATIENTS PARTNERING ADVISING IN THE ANALYSIS AND COLLECTION OF DATA. >> LOOKS LIKE TONY WANTS TO RESPOND. >> THAT'S IMPORTANT AND CRITICAL TO SOCIAL AND BEHAVIORAL CONSTRUCTS AND ONE OF THE MOST IMPORTANT THINGS. ONE QUESTION I HAVE IS A LOT OF THINGS PRESENTED ARE PREVENTED FROM CONNECTING TO THE GENOMICS DATA BECAUSE OF PATIENT PRIVACY ISSUES. I'M GOING TO THROW IT OUT HERE BUT MANY PEOPLE BELIEVE IT'S PREVENTING PROGRESS BECAUSE YOU CAN'T CONNECT THOSE THINGS YOU'RE SAYING ARE SO IMPORTANT WITH THE MOLECULAR AND BIO CHEMICAL DATA WHICH WE'RE ALL COLLECTING. SO I GUESS WHAT IS YOUR SENSE THEN ABOUT WOULD YOU BE WILLING TO SWITCH OFF A LITTLE BIT OF PRIVACY FOR SOME ADDITIONAL CONNECTION BETWEEN WITH THAT P.R.O.s AND PATIENT OUTCOME TO THE GENOMICS DATA IN THE FUTURE? >> I CAN'T SPEAK MONOLITHICLY ABOUT THE PATIENT COMMUNITY BUT I'VE DONE A BUNCH OF WORK IN THE LAST FOUR OR FIVE YEARS WITH PATIENTS ABOUT THEIR COMFORT LEVEL AND OVERWHELMINGLY WAS MORE ABOUT PRIVACY AND WHO IS MAKING MONEY OFF THIS AND WHAT ARE THEY DOING WITH MY DATA AND IF WE'RE TRULY GOING TO HAVE DEMOCRATIZATION IN HEALTH CARE DATA I WANT SOME SAY IN WHAT HAPPENS TO IT BUT AS LONG AS WE'RE NOT OPENING THE FLOODGATES DANGEROUSLY WIDE AND EXPOSING YOU TO DISCRIMINATION OR RISK OR WHO KNOWS WHAT, I THINK THERE CAN BE A BALANCE. IT'S MORE ABOUT FEELING EXPLOITED OR USED OR USED TO MAKE MONEY OFF OF, WE'RE ALL GETTING USED TO FACEBOOK AND WHOM EVER KNOWING A LOT OF ABOUT US. >> THESE COMMENTS ILLUSTRATE HOW RICH THIS TOPIC IS. ELIZABETH. THANK YOU FOR THE PRESENTATION AND I'D LIKE TO LEARN MOW ABOUT CYBER SECURITY IT'S AN IMPORTANT TOPIC AT TIME BECAUSE THERE'S A LOT OF HACKING GOING ON AND APPARENTLY THE DATA WE COLLECT BELONGS TO TWO CATEGORIES, ONE IS SECURE AND ONE NOT SECURE. COULD YOU COMMENT MORE ON THE CATEGORIES OF THE DATA AND HOW MUCH RESOURCE NIAMS AND NIH IS PUTTING UP TO SECURE FOR CYBER SECURITY. >> IT'D MAKE YOU SICK TO KNOW HOW MUCH MONEY AND THE BOTTOM LINE IT'S NOT GOING TO WORK. EVENTUALLY EVERYTHING GETS HACKED IN MY OPINION AND THE COMPANY THAT SOLD DATA SECURITY SOFTWARE AND ENDED UP HAVING MALWARE ATTACHED TO IT ILLUSTRATES HOW ALMOST IMPOSSIBLE IT IS. I WISH I HAD A BETTER ANSWER. WE DID JUST GO THROUGH AN AUDIT ON AND NIH GOT OUT ON THE TOPIC AND I DON'T HAVE A CONCRETE ANSWER FOR YOU BECAUSE I HAVEN'T HEARD AN UPDATE EXCEPT TO HEAR AT THE HIGHEST LEVELS IT'S TAKEN EXTREMELY SERIOUSLY. ON THE OTHER HAND, REALITY IS IT'S PRETTY TOUGH TO STOP ALL INFILTRATION. I DON'T HAVE A BETTER ANSWER. >> I DO THINK IT'S AN AREA WE'RE HOPING TO HEAR FROM INSTITUTIONS ON THE TRANSFER OF DATA AND INSTITUTIONS AND MOST LIKELY THROUGH INSTITUTIONS AND NIH APPROVED BIGGER REPOSITORIES OR KNOWLEDGE BASES F.R THERE'S GOING TO BE SIGNIFICANT DATA FROM INVESTIGATORS AND INSTITUTIONS. THE NKNOWLEDGE BASES AND ETCETERA THERE ARE CERTAIN STANDARDS BEING MET INCLUDING FOR CYBER SECURITY AND MAY BE A MOVING TARGET. I HOPE WHEN WE GET INPUT FROM THE NATIONAL LIBRARY OF MEDICINE REPRESENTATIVES THEY ARE ABLE TO INFORM THE WORKING GROUP ON THAT TOPIC AS WELL. >> OKAY. >> I HAVE A COUPLE MORE QUESTIONS. LUIS. >> A SMALL POINT. JUST TO EMPHASIZE, IT'S BEEN A RUNNING THEME BUT ESPECIALLY WITH THIS OPEN SESSION IT'S IMPORTANT TO EMPHASIZE WHAT MOST RESEARCHERS WHO MIGHT WATCH THIS ARE THINKING THAT EVERYBODY WANTS THE DATA TO BE REALLY EASY TO USE. I THINK LIKE IF YOU COULD TYPE IN YOUR -- I USED TO BE ABLE TO TYPE AND WRITE NCBIGO AND WITH A LINK MAKING IT SOMETHING LIKE THAT IF YOU TYPED IN YOUR FAVORITE GENE, R.A., GOOGLE COULD POP UP HOW MUCH HIGHER IT IS THAN R.A. OR PSORIASIS. UPLOADING OUR DATA IS IMPORTANT BUT ONLY IF A SMALL MINORITY ARE USING IT IT DEFEAT THE PURPOSE. MAKING STUFF MAXIMALLY USEFUL AND NIH RAMPING UP ONLINE TUTORIALS LIKE MAYBE YOU HAVE TO USE TYPE ON AND HERE'S AN ONLINE TUTORIAL ON A BEGINNERS GUIDE TO PYTHON. WAYS OF MAKING EASIER ESPECIALLY FOR TRAINEES. RIGHT NOW ALL OF US WANT BIOINFORMATICIANS AND FINDING TOOLS FOR EVERY RESEARCHER TO LEARN THIS IS HELPFUL. >> AND TONY HAS A COMMENT. >> I WANTED TO RESPOND TO THE POINT LEIGH BROUGHT UP. I HAVE A COMPOUND RESPONSE. THE FIRST ONE IS ONE OF THE INITIATIVES ODSS IS SPONSORING IN RESPONSE TO THE PLAN FOR DATA SCIENCE IS SUPPORTING BIO MEDICAL KNOWLEDGE BASE AND IT'S BEEN AROUND FOR LIKE GOING ON TWO YEARS. SO THE RATIONALE BEHIND THAT. THERE'S TWO. ONE IS THE PROJECTS DON'T DO WELL IN STANDARD REVIEW AND USUALLY REQUIRE A SEPARATE SPECIAL EMPHASIS PANEL TO EVALUATE THEM PROPERLY AND THE OTHER REASONS ARE WHAT YOU DESCRIBE WHICH IS THERE IS A RANGE OF USERS AND SOME USERS ARE MORE SOPHISTICATED AND SOME ARE NOT AND THE POINT OF THE KNOWLEDGE BASE IS PROVIDE THE INTERFACE THAT'S GOING TO ENABLE THE ENTIRE GAMUT OF USERS TO EFFECTIVELY ACCESS THE DATA AND BE ABLE TO WORK WITH IT. ACTUALLY, IN TERMS OF TRAINING PEOPLE TO USE CERTAIN PROGRAMS IS ONE OFF THE PURPOSE OF THE WORKFORCE DEVELOPMENT INITIATIVES AND PUBLIC BY ODSS IN THIS CASE AND NOSI AND IS AN AREA OF ACTIVE WORK WHERE THERE'S GOING TO BE MORE TO COME INCLUDING THINGS LIKE PROVIDING ACCESSIBLE TRAINING ON THE COMPUTATIONAL TOOLS AND MAKING USERS COMFORTABLE WITH USING THEM AS MUCH AS WE CAN. >> I'M LOOKING AT THE TIME AND WANT TO GIVE EVERYBODY TIME TO HAVE AN OPPORTUNITY TO GET UP AND STRETCH THEIR LEGS, ETCETERA. >> BEFORE WE LEAVE THE TOPIC BECAUSE IT SOUNDS LIKE YOUR CONCLUDING AND MAYBE THIS FITS IN VARIOUS PLACES BUT THANK YOU FOR EXCELLENT PRESENTATIONS. WE TALK A LOT ABOUT DATA SHARING AND EVERYONE AGREES TO SHARE BUT I'VE ALWAYS BEEN CONCERNED ABOUT NOT EVERYTHING CAN BE IN THERE AND THERE ARE NUANCES. WHEN IS THERE FEEDBACK TO THE PERSON WHO PROVIDE THE DATA BECAUSE IT'S IMPORTANT WHETHER IT'S A PATIENT REPORTED OUTCOME OR A VARIABLE WHERE THE UNITS MAY BE INTERPRETED IN SOME WAY OR SOME NUANCE TO THE FINALITY OF THE DATA THAT YOU'RE LOOKING AT COMPLETELY ABSENT OF THE PROVIDE WHO PROVIDED IT. AND WE REALLY HEAR ABOUT YES, YOU PUT YOUR DATA SOMEWHERE AND MANY ANALYZE BUT SHOULDN'T THERE BE SOME BACKYARD COMMUNICATION TO JUST MAKE SURE THAT HAS NO OTHER HUMAN DATA EXCEPT THE COMPONENTS YOU PUT IN THERE AND WONDER WHAT ROLE THE INITIATOR HAS WHICH IS SOMETIMES IGNORED. >> TONY. >> I WAS NODDING BECAUSE I THINK THAT'S AN EXCELLENT POINT. THE TRUTH OF THE MATTER IS THAT IT DEPENDS VERY MUCH ON THE DATA COORDINATION CENTER THAT IS ASSOCIATED WITH THIS SPECIFIC EFFORT AND ON HOW WELL THE META METADATA STANDARDS HAVE BEEN DEVELOPED UP FRONT AND IF THE COORDINATION CENTER IS ON TOP THERE'S DATA GOING BACK AND FORTH AND MAKE SURE EVERYTHING UPLOADED CAN BE USED AND EVERYBODY UNDERSTANDS WHAT IT IS THEY'RE LOOKING AT AND THE ONLY THING I WILL SAY IS IT VARIES BY THE BCC. I'LL STOP THERE. >> SO IT BE CONTINUED. WE'LL CONTINUE TO WORK TO ASSEMBLE THE GROUP AND FOR THOSE WITH ADDITIONAL THOUGHTS THAT COME TO MIND, WE CAN ALSO REVISIT THEM LATER IN THE AFTERNOON. I WANT TO MAKE SURE EVERYBODY GETS A BREAK. I'M TURNING THINGS BACK TO MELINDA TO TELL US WHAT TO DO AT THIS POINT. YOU'RE ON MUTE. >> YOU'RE STILL ON MUTE. IT'S PROBABLY A PHONE, COMPUTER ISSUE. >> WE'RE SCHEDULED TO COME BACK AT 12:45. >> THE QUESTION IS THAT OF TIME. ARE PEOPLE OKAY WITH 12:45. IT GIVES US 20 MINUTES? OKAY. STRETCH YOUR LEGS. GET YOUR CUP OF COFFEE. ETCETERA. WE'LL SEE YOU BACK IN AN A BIT. WELCOME BACK, EVERYBODY. DR. GAYLE LESTER WILL BE PRESENTING FOR THE NEXT TOPIC. THE NIAMS PROCESS ON THE RECEIPT OF LARGE BUDGET APPLICATIONS. SO GAYLE, WHEN YOU'RE READY. >> I'M READY. SO THIS IS A TOPIC THAT DR. CRISWELL WANTED US TO BRING TO YOUR ATTENTION. THE INSTITUTE HAS LONG RECEIVED BUDGETS OVER $500,000 FOR RO1 GRANTS OVER $500,000 AND MANAGED THE PROCESS RELATIVELY WELL. AND WE HAVE WANTED TO BRING TO YOUR ATTENTION SOME CHANGES THAT WE'RE GOING TO MAKE TO THIS PROCESS AND THEY'RE RELATIVELY MINOR AT THIS POINT BUT I THINK DR. CRISWELL WOULD LIKE US TO MAYBE THINK ABOUT WAYS THAT WE MIGHT BETTER MANAGE THIS PROCESS IN THE LONG RUN RELATIVE TO WHAT WE'RE GOING TO TALK JUST TODAY. SO IN THE SLIDES I'LL INTRODUCE YOU TO THE PROCESS BY WHICH NIAMS MANAGES LARGE BUDGETS AND APPLICATIONS WITH LARGE BUDGETS. NOW, I'LL START BY TALKING A LITTLE BIT ABOUT THE NIH POLICY OVERALL. THIS IS NOT SPECIFIC TO OUR INSTITUTE. ANYONE APPLIES TO A GRANT OVER $500,000 IN AND DIRECT COSTS FOR ANY YEAR INCLUDING ANY CONSORTIUM COSTS, THIS IS DIRECT COST ONLY, NEEDS TO SUBMIT A REQUEST FOR APPROVAL FOR ASSIGNMENT TO AN INSTITUTE. THIS IS IN THE FORM OF A LETTER OF REQUEST TO THE INSTITUTE AND THE INSTITUTE THEN LET'S THE CENTER FOR SCIENTIFIC REVIEW KNOW THIS LARGE APPLICATION WILL BE ACCEPTED BY THE INSTITUTE. THIS APPLIES TO ALL APPLICATIONS EXCEPT FOR THOSE IN RESPONSE TO REQUEST FOR APPLICATIONS, RFAs WHERE THERE ARE SPECIFIC BUDGETARY ALLOWANCES IN THAT FOA. THE PURPOSE OF THIS IS FOR BUDGETARY PLANNING. AS YOU MIGHT THINK ABOUT IT WITH A SMALL INSTITUTE, HAVING A NUMBER OF APPLICATIONS WHERE THE BUDGETS ARE IN THE $.75 TO $1.5 MILLION PER YEAR CATEGORY, COULD HAVE A TREMENDOUS IMPACT ON THE INSTITUTE BUDGET. SO JUST TO LET YOU KNOW ALL I.C.s AND I'LL FOCUS ON ALL THE NIAMS POLICIES BUT JUST TO LET YOU KNOW THAT OTHER I.C.s AND CENTERS MANAGER THESE IN QUITE DIFFERENT WAYS. THERE ARE A NUMBER OF INSTITUTES THAT DON'T ACCEPT ANY APPLICATIONS WITH REQUESTS OVER DIRECT OVER $500,000. SOME EXCEPT ALL REQUESTS AND THEN SET A SEPARATE PAY LINE FOR LARGE GRANTS SO IF YOUR NORMAL PAY LINE FOR AN RO1 WAS 20 OR IS A THE LARGER WOULD BE MUCH MORE MODEST THAN THAT NORMAL PAY LINE. SOME INSTITUTES AND CENTERS LIMIT THE GRANTS TO CERTAIN TYPES. MAYBE CLINICAL TRIALS ONLY OR SOME TYPE OF SCIENCE THAT REQUIRES A LARGE BUDGET APPLICATIONS. AND THEN THERE ARE OTHER INSTITUTES THAT HAVE SPECIAL REVIEW PANELS THAT WILL ASSIST THE INSTITUTE IN MAKING THESE DECISIONS. SO THESE ARE SOME OF THE PRACTICES SEEN AT NIH. THIS IS WHAT NIAMS DOES AND HOW WE MANAGE OUR OVER $500,000 KWF -- THAT COME INTO INSTITUTE. THE APPLICANT SEEKS APPROVAL. THEY'RE ENCOURAGED TO DISCUSS WHAT THEY'RE HOPING TO SUBMIT AND THE BUDGET AND PUT IN A REQUEST, THE LOR. IT CONTAINS A SYNOPSIS OF THE PROPOSAL, PERHAPS A CLEAR OUTLINE OF THE SPECIFIC AIMS AS WELL AS EXTENSIVE OR RELATIVELY EXTENSIVE BUDGETARY INFORMATION. THE NIAMS WEBSITE HAS ALL THE INFORMATION WHAT MUST BE INCLUDED. THEY DISCUSS EACH LOR RECEIVE AND DECIDE TO ACCEPT OR NOT THE LOR. ONCE THE DECISION IS MADE THEN IT'S COMMUNICATED TO THE APPLICANT AND THE APPLICANT IS TOLD THEY CAN SUBMIT AT A CERTAIN AMOUNT. THE APPLICATION IS SUBMITTED AND GOES THROUGH PEER REVIEW AND NIAMS HOLDS A FUNDING DISCUSSION AND MAKES A DECISION WHETHER TO FUND THE APPLICATION OR NOT. ONE THING CONCERNING TO SOME AM -- APPLICATIONS ARE NOT TO A FOA OR CLINICAL TRIAL ARE PERCENTILE AS ARE OTHERS REVIEWED IN THE STUDY SECTION NO MATTER WHAT THE AMOUNT OF THE BUDGET IS. AND IT DOESN'T STATE CLEARLY IN OUR WEBSITE RIGHT NOW THAT THESE FUNDING DECISIONS, THESE APPLICATIONS WOULD NOT BE INCLUDED WITHIN THE PERCENTILE PAY LINE. AND THAT FUNDING DECISIONS WOULD BE MADE ON A CASE BY CASE BASIS WITH THESE APPLICATIONS EVEN THOUGH THEY ARE REVIEWED IN THE CENTER FOR SCIENTIFIC REVIEW AND OUR PERCENTILE. SO LET'S GO ON TO THE NEXT SLIDE. SO HOW DO WE EVALUATE THESE LETTERS OF REQUEST? THE LETTERS OF REQUEST ARE FIRST LOOKED AT FOR THEIR RELEVANCE TO THE NIAMS MISSION. WILL THEY PROVIDE VALUABLE ADDITIONS TO THE EXISTING KNOWLEDGE BASE. SO THIS IS WORK THAT'S DONE BY THE PROGRAM DIRECTOR WHO RECEIVES THE LOR. THIS WOULD BE THE KIND OF BACKGROUND THAT WOULD BE INCLUDED IN EITHER A RECOMMENDATION TO ACCEPT OR RECOMMENDATION NOT TO ACCEPT AN LOR. THEY PROVIDE WHETHER THIS ADDRESSES SOME NEED FOR RESEARCH WORKFORCE AND THIS IS PARTICULARLY IN CASES AND WE DO HAVE THESE WHERE A T32 NOT AN RO1 IS SUBMITTED WITH A BUDGET OVER $500 TO,000 PER YEAR. FOR RESEARCH WITH HUMAN SUBJECT ONE QUESTION IS WILL THIS MOVE THE NEEDLE FORWARD FOR COMING UP WITH A NEW TREATMENT FOR THIS PARTICULAR DISORDER OR IMPACT THE PATIENT COMMUNITY AND IS THE BUDGET REASONABLE TO COMPLETE THE PROPOSED WORK. IS THE BUDGET TOO BIG? IS IT TOO SMALL? DOES IT SEEM ADEQUATE TO DO THE WORK OR NOT? WILL NIAMS HAVE THE FUNDING TO SUPPORT THE PROJECT AND THAT'S A SUBJECT WE DISCUSS AT EACH ONE OF THE MEETINGS. THE MOST IMPORTANT ONE RIGHT NOW IS THE ONEABOVE THAT. IS THE BUDGET REASONABLE TO COMPLETE THE PROPOSED WORK. BETWEEN THOSE QUESTIONS WE HAVE COME TO REALIZE THERE ARE SOME PROBLEMS WITH THE WAY WE MANAGE THESE. AND THE NEXT SLIDE WILL SHOW YOU WHAT WE TELL THE PEOPLE WHO HAVE BEEN APPROVED. SO THEY WILL GET A LETTER OR E-MAIL THAT SAYS NIAMS HAS REVIEWED YOUR LOR. WE WILL ACCEPT IT AND THE PARTICULAR COUNCIL REALM IT HAS BEEN SUBMITTED FOR WHICH WILL BE WRITTEN OUT AND THEN WE HAVE FREQUENTLY MODIFIED DIRECT COST IN THESE. IF WE FELT THAT THE BUDGET WAS TOO HIGH FOR THE WORK PROPOSED OR IF WE FELT LIKE IT NEEDED TO BE ADJUSTED FOR US TO BE ABLE TO CONSIDER IT FOR FUNDING. SO THAT IS WHAT WE MEAN BY THE DIRECT COST REQUESTED MUST NOT EXCEED A CERTAIN AMOUNT. WE DON'T USUALLY GIVE AN AMOUNT BUT IT HAS TO BE IN CONJUNCTION WITH WHAT THEY SUBMITTED. SO SOMETIMES THESE GRANTS COME IN AT MUCH HIGHER THAN THE REQUESTED AMOUNT WHEN THEY FINALLY GET WORKED UP BY THE GROUP THAT'S SUBMITTING IT. WHAT WE HAVE FUND IS THE LACK OF COMPLIANCE THAT THEY DO SUBMIT THE MUCH LARGER BUDGETS AND WE DO STATE THIS IN THE LAST SENTENCE MAY RESULT IN ADMINISTRATIVE CUTS OR DECISIONS NOT TO FUND THE AWARD. WELL, THIS HAS PROVEN TO BE VERY PROBLEMATIC FOR US BECAUSE FREQUENTLY THESE DO COME IN AT AMS HIGHER THAN THAT WAS APPROVED. AS YOU MIGHT UNDERSTAND WITH BUDGETING, THAT BECOMES DIFFICULT BECAUSE WE RECEIVE THESE AT EVERY RECEIPT DATE WE'LL HAVE ONE OR TWO OF THESE APPLICATIONS THAT COME UNDER CONSIDERATION. SO IF THEY'RE COMING IB -- IN AT THE TIME THEY'RE SUBMITTED AND REVIEWED AND COMPETED TO BE FUNDING AT A HIGHER AMOUNT THAN APPROVED AND PUT IN THE BUDGET, THEN THAT CAUSES US A LOT OF DISCORDANCE WITH REGARD TO THE AMOUNT WE THOUGHT WE WERE GOING TO BE SPENDING IN THIS PARTICULAR LINE. SO WE PROPOSED TO CHANGE THIS CURRENT PRACTICE OF SAYING LACK OF COMPLIANCE MAY RESULT IN ADMINISTRATIVE CUTS OR DECISIONS TO NOT FUND THE AWARD. BECAUSE THAT IS TO US VERY PROBLEMATIC AND CAUSES THE INVESTIGATORS TO SUBMIT AN APPLICATION THAT GOES THROUGH REVIEW AND THEN GETS THROUGH THAT WHOLE PROCESS WITHOUT ANY COMMENTS FROM THE INSTITUTE. SO WE PROPOSE TO CHANGE THAT LANGUAGE TO SAY ANY APPLICATIONS SUBMITTED OVER THE LOR APPROVED BUDGET WILL BE WITHDRAWN PRIOR TO PEER REVIEW. THIS IS A WAY TO AVOID -- IT DOESN'T AVOID THE APPLICATION COMING IN, BUT OUR HOPE IS THAT IN THE DISCUSSIONS WITH THE PROGRAM DIRECTOR THE APPLICANTS WOULD BE MUCH MORE COGNIZANT OF THIS AND HESITANT TO PUT IN THE OVER THE APPROVED BUDGET APPLICATION. SO THAT'S WHAT'S STATED IN OUR RATIONALE. WE DON'T WANT TO WASTE PEOPLE'S TIME AND RESPECT THE TIME OF THE REVIEWERS AS WELL AS THE APPLICANTS. SOMETIMES IF WE WERE TO CUT THE BUDGET AND WE HAVE DONE THIS PREVIOUSLY AND RUN INTO DIFFICULTIES HERE, THERE WILL BE AN INCONGRUITY BETWEEN WHAT WAS REVIEWED AND WHAT WAS ABLE TO BE FUNDED WITH THE AMOUNT OF FUNDS PROVIDED TO THE INVESTIGATOR. SO IT DIDN'T PROVIDE SUFFICIENT FUNDING TO PROVIDE THE GOALS THE WAY IT WAS INTENDED WITH THE HIGHER BUDGET. OUR FINAL COMMENTS ARE WE ARE GOING TO UPDATE OUR WEBSITE AND WE ARE GOING TO PUT IN THIS NEW LANGUAGE IN OUR LETTERS OF APPROVAL AND THIS WILL CLARIFY AND POST IT TO THE WEBSITE THERE'S BEEN CHANGES TO OUR POLICIES IN THIS AREA. THAT WAS ALL I WANTED TO PRESENT ON THIS BUT WE DID WANT TO MAKE COUNCIL AWARE AND MAKE THE PUBLIC AWARE THROUGH THE COUNCIL MEETING THAT THESE CHANGES ARE COMING UP VERY SOON AND THAT WE WILL BE POSTING THEM AND MAKING SURE THAT THEY ARE WIDELY DISSEMINATED TO THE COMMUNITY. SO I'LL BE GLAD TO TAKE ANY QUESTIONS AT THIS POINT. >> GAYLE, THANK YOU VERY MUCH FOR REVIEWING THAT AND I JUST WANT TO REFLECT BACK ONE OF THE COMMENTS YOU MADE UP FRONT WAS THIS IS AN OPPORTUNITY FOR COUNCIL MEMBERS TO REACT TO THESE PROPOSED CHANGES. WILL THIS ACCOMPLISH THE CLARITY AND HAVING EXPECTATIONS ALIGNED AND AN OPPORTUNITY FOR COUNCIL MEMBERS TO ACT MORE BROADLY TO THE APPROACH TO APPLICATIONS ALONG THE LINE AND INSTITUTES HAVE DISCRETION HOW THEY WANT TO MANAGE THIS ISSUE. WE ALSO HAVE AN OPPORTUNITY IN THE FUTURE TO CONSIDER CHANGES TO HOW WE VIEW AND MANAGE THESE APPLICATIONS. IF WE COULD MAYBE HAVE THE SLIDES SO WE'RE BACK IN GALLERY VIEW AND I SEE JOAN HAS A QUESTION OR COMMENT. >> HI, JOAN. >> HI, GAYLE. VERY NICE. I THINK IT'S VERY APPROPRIATE TO DO THIS. I TOTALLY AGREE WITH IT. I DO WONDER HOW CSR WILL KNOW THIS BECAUSE IS IT GOING TO BE FLAGGED SOMEHOW. HOW WILL WE INTERRUPT THE REVIEW PROCESS AND THE OTHER THING I WAS CURIOUS ABOUT WAS FOR INFORMATION, HOW MANY GREATER THAN $500,000 SUBMISSIONS ARE CLINICAL VERSUS BENCH RELATED? I HEAR MORE AND MORE BENCH SUBMISSIONS ARE HAVING THE LARGE BUDGETS THROUGH A LOT OF COLLABORATIONS AND CLINICAL INVESTIGATORS MAY BE A PART OF THOSE. >> I DON'T KNOW THE PRECISE NUMBER OF BASIC VERSUS CLINICAL ABOUT THE THE MAJORITY ARE CLINICAL PROPOSALS AND MANY ARE CLINICAL TRIALS. THERE AGAIN, WE DO TRY TO ENSURE THAT THERE ARE SUFFICIENT FUNDS AVAILABLE BECAUSE IT BECOMES A VERY IMPORTANT FACTOR FOR EVERYBODY INCLUDING THE PATIENTS WHO ENROLL IN THE STUDY THAT THERE BE SUFFICIENT FUNDING TO ALLOW THE RESEARCH TO BE CARRIED OUT APPROPRIATELY. >> HOW DO YOU TAG IT FOR CSR? >> OKAY, SO ALL OF THEIR CLINICAL TRIAL APPLICATIONS COME TO US DIRECTLY IF THEY'RE REVIEWED IN THE AMSC STUDY SECTION. SO WE SEE THOSE THEY COME TO US AND WE MANAGE THOSE DIRECTLY. ONCE WE PUBLISH THE LANGUAGE, IN OUR RECEIPT AND REFERRAL WHERE THEY COME IN THE INSTITUTE, THEY WOULD BE FLAGGED AND THEY WOULD BE RETURNED TO THE APPLICANT THROUGH THE PROGRAM DIRECTOR. THERE WOULD BE DISCUSSION BETWEEN RECEIPT AND REFERRAL FOLKS AND THE PROGRAM DIRECTOR THAT THIS IS OVER THE LOR BECAUSE IT IS STATED IN THE LOR BUT YOU ARE RIGHT, JOAN, WITHOUT THAT EXTRA STEP IN THERE, CSR IS HESITANT TO RETURN AN APPLICATION BUT ONCE WE TELL THEM THAT IT IS NOT IN COMPLIANCE WITH THE POLICY, THEN THEY WILL RETURN IT. >> THANKS. MAYBE A LITTLE MORE WORK ON OUR END WHEN THE APPLICATIONS ARE SUBMITTED. >> I'M HOPING WE WON'T HAVE MANY OF THESE. I'M HOPING WE CAN USE THE POLICY CHANGE TO KIND OF STOP THE INFLUX OF APPLICATIONS THAT COME IN WITH HIGHER BUDGETS THAN THEY PROPOSED BECAUSE IT'S NOT FAIR FOR ANYBODY TO HAVE THAT HAPPEN AND WHILE I UNDERSTAND IT'S HARD TO PROJECT, I WOULD HOPE YOU MIGHT DO YOUR BEST AT PROJECTING AT THAT ORIGINAL LOR STEP AND THEN NOT FEEL THE NEED AT THE TIME YOU SUBMIT THE APPLICATION TO EXCEED THAT AMOUNT OF MONEY. >> JILL, YOU HAVE A QUESTION? >> YES, I WANT TO SEPARATE TWO DIFFERENT THINGS IN SOME RESPECT. I, 100% SUPPORT THE LADDER. THE CONSENT YOU PUT IN AN LOR AND DO YOUR DUE DILIGENCE AND BECAUSE IT'S SUBMITTED 10 WEEKS AHEAD OF TIME IT SHOULD BE TOO SHORT OF TIME TO HAVE MADE HUGE CHANGES. INHERENT IN THE FACT THE LOR PROCEEDS THE ACTUAL SUBMISSION AND IT'S ALL LIKE VERY WELL LAID OUT IN YOUR INSTRUCTIONS, I SEE ENFORCEABLE WHAT YOU SAID. OTHERWISE, IT MAKES THE WHOLE PROCESS SILLY BECAUSE IF A REVIEWER GETS A GREAT SCORE, YOU'RE STUCK. AND AGAIN YOU EMPHASIZED THAT BEAUTIFULLY PARTICULARLY IF IT'S A PERCENTILE DRIVEN SITUATION. I WOULD JUST SAY I 100% EMPHASIZE THAT ASPECT OF THE POLICING. HOWEVER, I THINK THAT THERE ARE MAYBE TWO DIFFERENT CONSENTS HERE WHEN IT COMES TO THE LARGE BUDGET AND ONE I THINK A COUNCIL POINT FOR DISCUSSION WHEN WE GET INTO CLINICAL TRIALS WE TEND NOT TO DISCUSS THAT BUT WE AS COUNCIL MEMBERS WOULD LIKE INPUT IN THE CONSENT OF THE RUL34 TRANSITION AND THAT'S PROBABLY THE GREATEST PLACE WHERE THIS LOR BECOMES NEEDED BECAUSE IT'S ALMOST IMPOSSIBLE AND I THINK JOAN WOULD SUPPORT THAT TO DO A SERIES RCT WITH THAT AMOUNT OF MONEY. INHERENT IS THE CONSENT -- CONSENT OTHER INSTITUTES USE TO PLAN SOMETHING THAT COULD TAKE TWO YEARS BEFORE INSTITUTED AND PAY FOR THAT BUT ON THE OTHER HAND TO PAY FOR SOMETHING THAT YOU NEVER INTENDED TO ALLOW MORE THAN 500 IS ALSO A WASTE OF YOUR PLANNING DOLLARS. I DO THINK THAT TOPICALLY, WE MAY WANT TO TIE THIS INTO THE CONSENT -- CON AND DEF CONSENT AND-- CONCEPT AND WOULD BE A HIGH PRIORITY AT THAT TIME OTHERWISE THE MONEY IS WASTED. >> THAT'S SOMETHING WE'VE BEGUN DOING, JILL. WE HADN'T ALWAYS DONE THAT IN THE PAST. BUT IF WE DON'T THINK THE INSTITUTE WILL INTERTAIN THE UL 1, WE SHOULD NOT FUND THE R34. THAT IS VERY -- IT DOES KIND OF PUT US IN LINE TO BE BRINGING IN THE BEST UL 1s WE POSSIBLY CAN. >> I AGREE THOSE ARE TWO DISTINCT POINTS AND I'M EAGER TO HAVE A DEEP AND BROAD CONVERSATION WITH THE COUNCIL AND THERE ARE MANY PERSPECTIVES REGARDING THE PLANNING GRANT AND THE PHASE, ETCETERA. IT'S A REALLY IMPORTANT AND COMPLICATED TOPIC. THANK YOU FOR GETTING THAT ON OUR RADAR SCREENS AND LOOK FORWARD TO DISCUSSING THAT AS A FOCUS FOR DISCUSSION IN A SUBSEQUENT MEETING. ANY OTHER REACTION TO JILL'S COMMENTS AND WE CAN ALSO ENTERTAIN OTHER REACTIONS, SUGGESTIONS, COMMENTS ABOUT THIS TOPIC? >> I HAD ONE QUESTION. I'M CURIOUS FROM SOME OF THE NIAMS STAFF, WHAT'S -- MAYBE YOUR VISCERAL IMPRESSIONS. DO YOU THINK THE GRANTS THAT REQUIRED MORE THAN $500,000 PER YEAR, HAVE THEY BEEN HIGH YIELD FOR NIAMS AND FOR THE NIAMS' MISSION? LIKE IF YOU WERE TO DO A RETROSPECTIVE OF HOW WELL THOSE GRANTS FARED, WHAT DO YOU GUESS THE ANSWER WOULD BE? ANY THOUGHTS? >> YOU MEAN AS FAR AS THEIR SCORES? >> THEIR IMPACT. DID THEY MOVE THE NEEDLE IN THE END. WITH HINDSIGHT YOU CAN DO THAT ANALYSIS. WHAT DO YOU THINK? >> WE HAVEN'T DONE IT BUT MY IMPRESSION IS WITH THE CLINICAL TRIALS OVER HALF A MILLION, THEY ARE HIGHLY IMPACTFUL. MANY. MOST, I WOULD SAY. BOB, YOU CAN THINK ABOUT THAT TOO BECAUSE YOU HAVE AN OPINION ON THAT. >> THINKING ABOUT MRIs WHICH HAS TO DO WITH THIS AUDIENCE. THOSE ARE EXPENSIVE AND IF YOU DO LONGITUDINAL STUDIES YOU'LL HAVE TO PAY FOR IT BUT SOME HAVE BEEN GAME CHANGERS. THEY'VE CHANGED THE UNDERSTANDING AND THINKING PARTICULARLY OF THE MUSCLE ONES BUT BONE TOO. AND ACTUALLY AND UNDERSTANDING OF THE ENGINEERING OF BONE IS RECOGNIZED BY THE MRIs. SO IN THOSE CASES WHERE THAT'S THE BEST WAY TO GET DATA, I WOULD SAY THEY'VE BEEN QUITE IMPACTFUL. THIS IS NOT AN OBJECTIVE ANALYSIS. THIS IS AN IMPRESSION BASED ON WHAT I'VE SEEN. I WOULD SAY WE DO GIVE THESE SPECIAL SCRUTINY AS GAIL DESCRIBED. BUT SOME OF THE TIMES, IT IS NECESSARY TO PAY FOR THOSE TYPES OF STUDIES BUT THEY DO HAVE ESPECIALLY THOSE WHO TAKE NEW TECHNOLOGIES TO STUDY HUMANS WIND UP BEING IMPACTFUL. >> ONE THING I'M EAGER TO DO IS WHENEVER POSSIBLE HAVE DATA TOO DRIVE DECISIONS AND ONE THING I'M EAGER TO SHARE WITH COUNCIL AT SOME POINT IS AN ANALYSIS OF OUR PORTFOLIO WHICH ANSWER MS. QUESTIONS AND METRICS RELATED TO RETURN ON INVESTMENT AND THERE'S AN OFFICE DEVOTED TO THIS AT THE NIH WE ARE NOW COLLABORATING WITH. SO THOSE ARE GREAT QUESTIONS. THEY'RE HARD TO ANSWER. YOU CAN GET SOME KIND OF REACTION LIKE YOU'RE GETTING NOW BUT I'M LOOKING FORWARD TO A POINT WHERE WE CAN ALSO TRY TO APPLY SOME DATA-DRIVEN APPROACHES TO ASK SOME OF THESE QUESTIONS. >> SOMETIMES AND SOMETIMES THEY'RE IN THE $650,000 THAT ARE HIGHLY SOPHISTICATED AND VERY IMPACTFUL AND IF WE TOOK THE POLICY WE WON'T TAKE ANYTHING OVER $499,999 OR WHATEVER IS BELOW 500. WE WOULD MISS SOME OF THESE SOPHISTICATED STUDIES THAT HAVE BEEN CARRIED OUT AND PARTICULARLY I'M THINKING OF THE MUSCLE GROUPS HAVE DONE SOME EXQUISITE WORK WITH THIS. NOT $2 MILLION, $3 MILLION BUT A LITTLE BIT OVER CAN MAKE A BIG DIFFERENCE SOMETIMES. THAT'S WHY WE WANT TO KEEP IT AVAILABLE. >> OKAY. ANYBODY ELSE? >> WE'RE RIGHT ON TIME. WE'RE TWO MINUTES AHEAD OF OUR INTERNAL SCHEDULE. THANK YOU GAYLE AND LOOK FORWARD TO DISCUSSING SOME OTHER ISSUES RAISED TOO. NEXT IS CONCEPT CLEARANCE. I DON'T KNOW WHETHER MELINDA WANTED TO MAKE AN SPECIFIC INTRODUCTION TO THE SECTION? >> THIS IS A SLIDE ON WHAT CONCEPT CLEARANCE IS AND GAYLE LESTER WILL PRESENT SEVERAL OF THESE CONCEPTS FOR YOU THAT INDEED MAY BECOME POTENTIAL INITIATIVES THAT WE MAY PURSUE IN THE FUTURE BUT CONCEPT CLEARANCE BASICALLY IS THE FIRST STEP WE ARE REQUIRED TO BRING ALL CONCEPTS TO THE PUBLIC AND WHY WE'RE DOING IT IN THE OPEN SESSION OF COUNCIL. AGAIN, GAYLE WILL PRESENT TWO CONCEPTS TO YOU AND WE'LL DOES FOR YOUR ADVICE AND FURTHER INPUT. GAYLE. THANK YOU. >> TODAY I'M GOING TO PUT FORTH TWO CONCEPTS. DR. CRISWELL EXPLAINED EARLIER THESE ARE GENERAL TOPICS THAT MAY OR MAY NOT BE PURSUED BY EITHER AN INITIATIVE SUCH AS FUNDING OPPORTUNITY OR A ROUND TABLE OR WORKSHOP OR SOME ACTIVITY THAT THE INSTITUTE WOULD TAKE RELATIVE TO THIS PARTICULAR TOPIC. THE FIRST ONE IS ONE WE'RE DOING WITH PARTNERS. IT WAS REFERRED TO EARLIER. IT'S AN OFF SHOOT OF THE HEAL PARTNERSHIP THAT NIAMS HAS FORMED WITH A NUMBER OF OTHER INSTITUTES AND CENTERS. THE TOPIC IS MAPPING NEURONS TO UNDERSTAND MECHANISMS OF JOINT PAIN. THE SECOND ONE AND I'M GOING GIVE YOU A LITTLE MORE DETAIL ABOUT THAT IN JUST A MOMENT. SECOND ONE IS COLLABORATIVE RESEARCH IN CHRONIC PAIN AND THAT IS GOING TO BE NIAMS ALONE AND THIS IS IN RESPONSE TO THE POSSIBILITY THAT THERE WILL BE INCREASED FUNDS APPROPRIATED TOWARDS IMPROVING PAIN RESEARCH IN NIAMS MISSION AREAS. SO THE FIRST CONCEPT, MAPPING NEURONS TO UNDERSTAND MECHANISMS OF JOINT PAIN. THIS IS A GLOBAL INITIATIVE TO SUPPORT RESEARCH WITH WHAT WOULD INVOLVE MAPPING OF SENSORY NERVE TERMINALS IN DIFFERENT AREAS OF THE JOINT. ALSO INVOLVING TRACKING THE INNERVATION CHANGES WITH AGING AND DISEASE INCLUDING ARTHRITIS AND OF THE OSTEOARTHRITIS. THEth. PROJECT WILL HOPEFULLY LEAD TO THE TRANSLATION OF RESEARCH ON NERVES AND MEDIATORS INTO THE DISCOVERY OF NEW INHIBITERS OF PAIN. WE'RE TRYING TO LOOK AT PAIN FROM A DIFFERENT POINT OF VIEW BUT STILL BE IN THE AREA OF THE MISSION AREA OF THE INSTITUTE. THE FINAL COLLABORATIVE RESEARCH IN CHRONIC PAIN IS A GENERAL DESCRIPTION OF THE TYPES OF THINGS THAT MIGHT BE DONE WERE THERE TO BE ADDITIONAL FUNDING RELATIVE TO PAIN RESEARCH. THIS WOULD BE IN BOTH ADULTS AND CHILDREN AND THE DISEASE AREAS WITHIN NIAMS MISSION IT WOULD SUPPORT BASIC, CLINICAL AND TRANSLATIONAL PROJECT. PERHAPS WITH A FOCUS TOWARDS PRECISION MEDICINE TO IDENTIFY THE CHALLENGES AND PREVENTION AND TREATMENT OF CHRONIC PAIN. AND MAY REQUIRE SOME TYPES OF INFRASTRUCTURE WHICH WE LOOKED INTO THE POSSIBILITY THIS COULD BE PART OF THE INITIATIVE OR CONCEPT. AND THE PROJECTS WOULD GENERATE RESOURCES TO BE SHARED WITH THE COMMUNITY AND FOST EVER DISCOVERY OR HYPOTHESIS GENERATING SCIENCE. THIS IS IN LINE WITH MAKING EVERYTHING SHAREABLE AND IMPROVING OUR ABILITY TO UNDERSTAND DISEASE FROM THE BIGGER PICTURE AND PAIN BEING ONE OF THE UNDERLYING CHARACTERISTICS OF MANY OF THE DISEASES OF NIAMS HAVE SOME TYPES OF RESOURCES THAT MAY CROSS DISEASE AREAS AND ENABLE US TO UNDERSTAND THE MECHANISMS OF CHRONIC PAIN. THAT'S ALL I WANTED TO SAY ON THE CONCEPTS BUT WOULD BE GLAD TO ENTERTAIN QUESTIONS ON EITHER ONE OF THEM. THEY'RE JUST IDEAS AND ANY OTHER IDEAS PEOPLE WANT TO ENTERTAIN AS WELL. >> AND THANK YOU FOR GOING BACK TO GALLERY VIEW. TO CLARIFY THE FIRST CONCEPT GAYLE MENTIONED WAS CONCEIVED IN THE CONTEXT OF HEAL AND THERE'S ALREADY BEEN DISCUSSION AND SOCIALIZING ABOUT THE CONCEPT IN PARTICULAR INCLUDING WHAT COULD BE ACCOMPLISHED DURING AN INITIAL YEAR OF FUNDING AND THAT CONCEPT WILL BE DISCUSSED INITIALLY TOMORROW OVER THE NEXT TWO DAYS IN THE HEAL PLANNING EFFORTS AND ALSO SOMETHING TO SIT WELL IN THE PORTFOLIO. SECOND ONE CAN BE INTENDED TO BE VERY BROAD SO IT COULD ENCOMPASS MANY NOT THAT ANY TOPIC HAS TO TOUCH ALL TOPICS BUT WE WANTED THE CONCEPT TO BE BROAD TO GIVE US FLEXIBILITY WITHIN THAT. THOUGH WE'RE CHARACTERIZING IT AS BEING NIAMS SPECIFIC, OTHER INSTITUTES CAN JOIN US IN THE EFFORT OF COLLABORATIVE RESEARCH IN PAIN. >> IT'S EXCITING BECAUSE OF THE ISSUE OF CHRONIC PAIN. I WANT TO MAKE SURE PAIN AT LEAST IN THE SKIN REALM INCLUDES THE SAME RECEPTORS FOR ITCH. AND CONSIDER THE SAME SENSORY INPUT WHICH INCLUDES ITCH AND PAIN TOGETHER. THE SECOND THING IS IN TERMS OF CHRONIC, WE KNOW THAT SO MUCH OF THAT IS ALSO NOT AT THE PERIPHERAL LEVEL BUT CENTRAL LEVEL AND NEED TO CONNECT THOSE ISSUES IN TERMS OF PERCEPTION AT THE CNS LEVEL. WE WANT TO MAKE SURE WE CONNECT THAT TOGETHER. THEN LASTLY, JUST TO THROW IT OUT THERE, WE JUST HEARD OF AGAIN ABOUT HOW TO AMP IS THE WAY TO DO COLLABORATIVE STUDIES SO WHAT ABOUT THE AMP APPROACH WHERE WE USE THE MONEY TO THEN GO AND FISH FOR OTHER LEVERAGING PARTNERS. >> THOSE ARE GREAT COMMENTS. I WANT TO GIVE BOB AN OPPORTUNITY TO RESPOND AND HE'S BEEN INVOLVED IN THE FIRST CONCEPT IN PARTICULAR. BOB, DID YOU WANT TO OFFER SOME RESPONSE AND WE'LL ALLOW OTHERS ALSO. >> THE IDEA OF AN AMP LIKE IN PAIN IS CERTAINLY ON THE TABLE. IF WE ARE SO FORTUNATE TO GET A BOLUS OF FUNDS, THEN IT'S SOMETHING WE'LL CONSIDER. AT THIS POINT WE'RE KEEP THING RATHER VAGUE AND THAT CONCEPT IS TO WHAT EXTENT DO WE TRY TO. THE DOORS WIDE AND LACK FOR NEW IDEAS AND WHAT -- LOOK FOR NEW IDEAS AND WHAT EXTENT TO WE BUILD A PROGRAM LIKE AMP. TO THE SECOND POINT, WE HAVE TO BE CAREFUL THE LANGUAGE THAT GOES TO CONGRESS FOCUSSED ON PAIN. NO QUESTION SOME OF THE FIBERS ARE SHARED, SOME SEPARATE, SOME USED. INTERNALLY, IT'S MORE OR LESS EQUIVALENT TO PAIN BUT EXTERNALLY WE'D HAVE TO BE CAREFUL TO PUT IT MILDLY. SO IF THERE ARE OPPORTUNITIES TO STUDY ITCH IN THE CONCEPT OF PAIN, I THINK IT WOULD WORK WELL BUT WOULD HAVE TO BE COUCHED LIKE THAT. >> THANKS, BOB. >> I HEARD ABOUT JOINT PAIN AND SKIN AND PAIN AND ITCH AND I THINK ONE OF THE BIG AREAS FOR PAIN IS PROBABLY MUSCLE PAIN PEOPLE ARE GOING THROUGH NOT ONLY IN PATIENTS BUT ALSO FOR EXERCISE AND INJURY. I THINK IT COULD BE A BIG AREA TO EXPLORE AS WELL. >> I THINK THE KEY FACTOR MAY BE MUSCLE PAIN. YES, ABSOLUTELY. >> THIS IS KAREN. THE ONE THING I HOPE WE'LL ALSO ADDRESS IS THE NOCICEPTIVE WAY TO INCREASE THE DIAGNOSIS OF THE PAIN. ESPECIALLY LOOKING AT IT MORE FROM THE JOINT OF THE -- OF THE YO ARTHRITIS -- OSTEOARTHRITIS PAIN AND PEOPLE CAN BE IN PAIN FOR A YEAR BEFORE THEY IDENTIFY THE SOURCE WHETHER IT'S A TORN GLUTEUS MAXIMUS MUSCLE FROM A SMALL WHEN THEY'RE ACTUALLY LOOKING AT SCIATICA AND I THINK IT WOULD BE GOOD TO LOOK AT THAT. >> EXCELLENT POINT. JOAN. >> TONY BROUGHT UP THE MODEL OF AMP AND I HAD ALSO HAD BEEN THINKING WHILE YOU WERE TALKING ABOUT THE BACPAC MODEL BECAUSE THAT SEEMS FITTED TO SOMETHING LIKE THIS IF IT'S GOING TO BE A GROUP APPROACH WITH THE AMOUNT OF MONEY YOU MIGHT GET SEEMS LIKE SOME SHOULD BE GROUP ORIENTED AND BACPAC HAS BASIC MECHANISTIC STUDIES WITH CLINICAL STUFF AND THEY WERE WORKING FOR A CLINICAL TRIAL THAT WOULD HAVE PRECISION MEDICINE ASPECTS. THAT'S ANOTHER MODEL TO CONSIDER. >> THAT'S A LOT BIGGER BUDGET BUT IT WOULD BE A GOOD MODEL TO USE, I THINK. >> THE BIG CLINICAL STUDY WILL DO PRECISION MEDICINE IN A VERY INNOVATIVE WAY I HOPE WE HAVE A CHANCE TO REVIEW AGAIN WITH YOU ALL. BUT IT'S USING MOSTLY EXISTING THERAPIES AND WE KNOW HOW GOOD THOSE ARE. AND SURE, FINDING THE RIGHT PERSON FOR THE RIGHT PERSON IN THE RIGHT ORDER IS GOING TO HELP BUT AT THE END OF THE DAY, I THINK WE ALSO NEED A MORE DISCOVERY-BASED APPROACH. AND THE AMOUNT OF DISCOVERY WORK IN BACPAC IS A LITTLE BIT LIMITED. YOU'RE BASIC PLAYERS IS IT IS GETTING A TEAM TOGETHER AND WE MADE THE POINT THAT IF THEY WORK IN SILOS WE WILL HAVE FAILED. I THINK THIS WILL BE TRUE AS WELL. >> GO AHEAD. >> I THOUGHT IT THE CLINICAL TRIAL WAS ALREADY AVAILABLE. I ALSO AGREED WE DON'T WANT THAT. >> OKAY. THE EMPHASIZE IS TEAM SCIENCE IS A THEME WE'RE DISCOVERING AND -- >> EVENTUALLY IT WOULD BE, YEAH. I WOULD ALSO MENTION AGAIN MAYBE IT'S AN INCREDIBLE OPPORTUNITY TO THINK OUT OF THE BOX. WE THINK MUSCULOSKELETAL AS ARTICULAR AND SOMETIMES PEOPLE COMPLAIN ABOUT PAIN AND WE DON'T KNOW WHY AND THERE'S PAPERS THAT LOOKED AT WAYS OF THINKING OF AUTOIMMUNE ANTIBODIES THAT MAY MEDIATE PAIN AND THIS COULD BE AN OPPORTUNITY TO THINK WHERE WE HAVEN'T THOUGHT BEFORE ABOUT SOME OF THE IDEOLOGIES WHERE WE FACED PATIENTS WHO ARE REALLY IN PAIN BECAUSE WE BELIEVE THAT IN EVERY WAY POSSIBLE YET OUR EXAMINATIONS ARE NORMAL BUT WHAT IS THERE LURKING IN SOME OF THEIR CYTOKINES OR TRANSCRIPTOMIC MODULE OR AUTOANTIBODY PROFILES THAT COULD CHANGE THE WAY WE THINK? I'M LOOKING AT THIS OPPORTUNITY AS REALLY UNIQUE TO THINGS I PERSONALLY HAVE NOT YET ENTERTAINED. >> IT'S A REMOTE LIST. SUSAN AND I HAVE LOOKED AT THE PAPERS AND THE MOUSE WORK IS CONVINCING, PROVEN CAUSALITY IN HUMANS IS HARD. >> WOULDN'T THAT BE EXCITING AND FOR THE WORK YOU AND SUSANA HAVE PRESENTED TO US, IT WOULD BE A VERY UNIQUE OPPORTUNITY IF FASHIONED RIGHT, I THINK PAIN COULD TAKE ON AN IMAGERY AND SUSANA SHARED PAPERS WITH ME A WHILE AGO AND THEY'RE VERY INTERESTING. THANK YOU VERY MUCH. >> ROOT CAUSES IN LUPUS. >> AND IT'S TAKING YEARS TO COME TO THE CONCLUSION AND I THINK THE PATIENT ADVOCACY GROUPS HAVE TO BE REALLY ENCOURAGED FOR HAVING MADE US STAND UP AND LISTEN. >> THESE ARE GREAT COMMENTS AND POINTS AND I THINK JENNIFER WANTED TO MAKE A COMMENT OR ASK A QUESTION TOO. >> I THINK THESE ARE GREAT CONCEPTS FROM THE BASIC DISCOVERY SIDE. I THINK SOME TOOLS ARE IN PLACE TO DO THIS AND MAKE SUBSTANTIAL PROGRESS. THERE'S MOUSE MODELS AND BASELINE DATA AND ATLASES AND WHAT KIND OF NERVES ARE INNERVATING ALL KINDS OF MUSCULOSKELETAL TISSUES. NOW'S THE TIME TO LAUNCH AND GO AFTER THOSE ATLASES. >> THE FIRST CONCEPT IS PULLING RIGHT OFF THAT DATA DIRECT ACTIVATION OF NEURONS AND UNDERSTANDING NEURO ITE ACROTH IN THE SETTING. >> THAT FIRST CONCEPT IS PERIPHER PERIPHERAL. >> AND ACTIVATION IN THE BRAIN IS CORRELATED WITH PERIPHERAL SENSORY AND PERCEPTION WHICH IS COMPLETELY LOST. >> YEAH, I WILL PUSH BACK A LITTLE, TONY. I THINK THE PENDULUM SWUNG THE OTHER WAY A LITTLE TOO FAR AND NOW KNOW MORE ABOUT SECONDARY PAIN RATHER THAN WHAT ACTIVATES THE NERVES IN THE SETTING OF THE LOCAL DISEASE IN THE TISSUES. I THINK THAT'S WHERE WE DON'T KNOW. ABSOLUTELY, CHRONIC PAIN IS DETERMINED BY WHAT HAPPENS IN THE CNS, NO QUESTION. BUT WHAT HAPPENS IN A JOIN ARTERIAL ARTHRITIS AND WE HAVE NO IDEA BUT NOW WE KNOW CHEMO KINES CAN ACTIVATE NEUROITES. >> WE CAN TALK ABOUT THE DRGs A LITTLE BIT TO MEET YOU IN THE MIDDLE. >> THAT'S WHY THE FIRST CONCEPT IS TO TAKE THEM AND MAP THEM THROUGH DIFFERENT TYPE OF FIBERS TO UNDERSTAND THE NOCICEPTIC FIBERS AND HOW THEY CHANGE WITH ARTHRITIS. WE DON'T KNOW. >> TO THE SECOND CONCEPT MAKE SURE WE INCLUDE SOCIAL DETERMINATES OF HEALTH. IT'S BRIEFLY INEQUITY BUT HEALTH EQUITY BUT SOCIAL DETERMINATES MAY BE A BETTER PHRASE TO USE THERE. >> AGREED. >> I'M INVOLVED IN A PROJECT WITH THE DENTAL INSTITUTE ON TMJ AND I'M NOT -- BEN MAY BE BETTER SUITED FOR THE SECOND CONCEPT AS A COLLABORATIVE PROJECT. >> THE FIRST ONE WITH HEAL IS WITH DCR AND LOOK ACROSS DIFFERENT JOINTS AND FOR THEM TO BE EXCITED AND I DON'T MEAN THAT -- TMJ IS INCLUDED FOR A LOT OF REASONS AND HELPS THEM GET EXCITE AND PARTICIPANT. >> AND I'M PICKING UP ON SOMETHING JEN SAID YOU KEEP SPAWNING IDEAS FOR ME IN THE THINGS THAT ARE VALUABLE FOR PATIENTS I'M SURE TWO CONCEPTS ARE EMBEDDED ALREADY BUT I'LL RAISE THEM JUST IN CASE. ONE IS THE ISSUE OF LOSS OF BASELINE AND ESPECIALLY THIS MATTERS IN CLINICAL TRIALS AND EVEN IN MANAGING OUR DISEASE LONG TERM UNDERSTANDING WHAT A NORMAL AMOUNT OF PAIN IS VERSUS AN ABNORMAL AMOUNT OF PAIN AND HOW WE COMMUNICATE IT AND THE TOOLS WE HAVE TO REPORT PAIN. PATIENTS OFTEN GRIPE ABOUT LAGERT SCALES BUT HOW DO WE MEASURE IT IN WAYS THAT ARE MEANINGFUL NOT JUST HYPOTHETICALLY MEANINGFUL. A LOT OF THE DISSATISFACTION WITH THERAPY AND CARE COMES FROM THE INABILITY TO NAIL DOWN PAIN AND WE CAN LOOK AT BLOOD MARKERS AND CAN LOOK AT THE GENERATION ON X-RAY. PAIN IS JUST A TOUGHER ASPECT. THERE'S PRACTICAL APPLICATIONS AROUND MEASURING AND CAPTURING AND TALKING ABOUT IT THE WAY PATIENTS DESCRIBE IT. IT WILL BE A REALLY IMPORTANT SEQUELAE FROM WHAT WE DO AROUND THE BIOLOGY. GOING INTO IT WITH THE END IN MIND AND ANYTHING WE CAN TO TO LEARN THOSE PIECES IS GOING TO BE REALLY IMPORTANT. >> THANK YOU SO MUCH. I APPRECIATE YOU ALL SPEAKING UP WITH YOUR DIFFERENT PERSPECTIVES AND EXPERIENCE. THANK YOU SO MUCH. I THINK LUIS YOU WANTED TO MAKE A COMMENT AFTER THAT. >> A QUICK COMMENT. I THINK PEOPLE SAID IS SO APPROPRIATE AND TRUE BUT JUST TO RAISE ANOTHER ISSUE A LOT OF OUR PATIENTS COMPLAIN ABOUT IS STRESS. SO I DON'T KNOW IF YOU WANT TO TAKE THE OPPORTUNITY AT HOW PSYCHOLOGICAL STRESS AFFECTS ALL THE CONDITIONS WE STUDY PARTICULARLY IN THE SKIN IT MAKES ANYTHING WE LOOK AT WORSE LIKE I SEE PATIENTS FROM LIKE DIVORCES AND STUFF LIKE THAT AND IF THERE'S FUNDING AND THERE ARE FUTURE INITIATIVES WORTH THINKING ABOUT HOW STRESS CAN LEAD TO OPIOID MISUSE AND ALSO HOW STRESS AFFECTS ALL NIAMS MISSIONS. >> SLEEP AS WELL. >> THIS IS GREAT. I LOVE THE EMPHASIS ON SOME OF THE TOPICS THAT ARE TIMELY SUCH AS SOCIAL DETERMINATES AND PATIENT'S HEALTH. WE STILL HAVE MORE TIME FOR DISCUSSION ON THIS TOPIC. IF THERE'S OTHER THOUGHTS YOU WANT TO SHARE BASED ON THINGS COMING TO YOUR MIND AS WE HAVE THIS DISCUSSION. AND IF NOT, THEN OH, MY WORD, THAT BRINGS US TO THE LUNCH BREAK. ONE LAST CALL FOR QUESTIONS BEFORE WE MOVE TO THE LUNCH BREAK. >> WHAT WE'LL NOW DO IS TAKE A LUNCH BREAK AND AT 3:00, WE'RE GOING HAVE THE BOARD OF SCIENTIFIC COUNCIL MEMBERS REVIEW AND YOU ALL HAVE A SEPARATE LINK FOR THAT MEETING. SO AT 3:00, COUNCIL MEMBERS WILL COME BACK ON THE NEW ZOOM FOR. NOW, THE CLOSED SESSION OF COUNCIL, THAT INCLUDES STAFF AND STAFF IS NOT INCLUDED IN THE BOC AND EVERYBODY HAS A SEPARATE ZOOM LINK. SORRY. SO IN ZOOM LINK. WE'LL SEE THE COUNCIL MEMBERS AT 3:00 FOR THE B OC REVIEW AND SEE THE REST OF YOU AT 3:30 WHEN THE AFTERNOON SESSION. >> BEFORE WE BREAK UP HERE IF I CAN SAY I JUST WANT TO THANK MEMBERS OF THE PUBLIC WHO ARE LISTENING IN ON THE VIDEOCAST AND REMIND THEM THERE IS A BUTTON THERE NEW WANT TO SEND QUESTIONS AND COMMENTS, WE REALLY WELCOME THAT OPPORTUNITIES. I WANT TO THANK THOSE OF YOU WHO ARE LISTENING IN AND PLEASE FEEL FREE TO RESPOND AND REACH US TO US IN THAT WAY. >> ALL-RIGHTY. I'LL SEE YOU LATER. >> THANK YOU.