>> WELCOME. GOOD MORNING, EVERYONE. WELCOE TO THIS NIH COUNCIL OF COUNCILS MEETING, IT'S NOW IN SESSION. IT'S A PLEASURE TO BE HERE WITH YOU TODAY. AND I EMPHASIZE HERE, BECAUSE NOW WE'VE BECOME THE PERIPATETIC COUNCIL, IN SEPTEMBER WE'LL BE IN NATCHER. BEYOND THAT I'M NOT SURE. BUT I PROMISE THERE WILL BE A PLACE. TODAY UNFORTUNATELY DR. KEVIN JOHNSON AND SATCHEN CATERCAL CAN'T JOINT US, AND DR. BRUCE PAGALI IS ON THE PHONE. LET ME ASK, BRUCE ARE YOU ON? I THINK I HEARD HIM. BRUCE, ARE YOU ON MUTE? WE'LL COME BACK. HE'S PERIPATETIC APPARENTLY. WE HAVE A NUMBER OF NEW COUNCIL MEMBERS TODAY. WE'LL GO AROUND THE GIVE, GIVE YOUR AFFILIATION, CURRENTLY ON I.C. COUNCIL, LET US KNOW IF YOU'RE KNOW. THANK YOU TO YOU AND ALSO TO MANY OF YOU WENT OUT TO DINNER LAST NIGHT. WE HAD A GREAT TIME, A GREAT VENUE AND MAY GO BACK THERE NEXT TIME. THE SPEAKERS HAVE A LIMITED CAPACITY TO TAKE UP SOUND, SO PLEASE TURN ON AND OFF YOUR MICROPHONE AFTER YOU SPEAK. THERE ARE THERE HAVE BEEN QUITE A NUMBER OF LEADERSHIP CHANGES, SO I'M GOING TO GO THROUGH THEM. AS YOU MAY HAVE HEARD DR. STEVE KATZ WHO WAS THE VERY LONG-TERM DIRECTOR OF THE NATIONAL INSTITUTES OF ARTHRITIS AND MUSCULOSKELETAL DISEASE DIED SUDDENLY DECEMBER 20, STEVE WAS A MENTOR TO MOST OF US, A GREAT LEADER AND WE'RE GOING TO MISS HIM. BOB CARTER WILL BE TAKING OVER AS THE ACTING INSTITTE DIRECTOR PENDING RECRUITMENT SEARCH SOON. HELEN LONGEVIN, DR. BRUCE TROMBERG IN DECEMBER, HE WAS ABOUT TO STEP IN ON THE COUNCIL OF COUNCILS BUT OVERALL NIH GRAINED A GREAT NEW INSTITUTE DIRECTOR. WE'LL INVITE THE NEW DIRECTORS TO SPEAK AT SOME TIME AT OUR FUTURE COUNCIL MEETINGS. WE'RE RECRUITING FOR DIRECTORS OF CENTER OF SCIENTIFIC REVIEW, AN IMPORTANT ROLE FOR ALL OF YOU, FOR THE NATIONAL INSTITUTES OF DEAFNESS AND OTHER COMMUNICATION DISORDERS, FOR THE NATIONAL INSTITUTE OF NURSING RESEARCH, AND WE'RE VERY RELEVANT TO OUR GROUP HERE, WE'RE RECRUITING FOR THE CHIEF DATA STRATEGIST WHO WILL SERVE AS THE DIRECTOR OF OUR NEW DPCPSI OFFICE ON DATA SCIENCE STRATEGY. THIS IS AN OFFICE THAT'S BEING STOOD UP NOW. IT WILL TAKE A LEAD IN IMPLEMENTING NEW NIH STRATEGIC PLAN FOR DATA SCIENCE AND YOU'LL HEAR MORE ABOUT THE OFFICE. WE'RE UNDERGOING -- WE STARTED A SEARCH FOR THE NEW DIRECTOR OF OFFICE OF DIETARY SUPPLEMENTS, AFTER PAUL COATES RESIGNED IN JULY. AND SOME OF YOU HAVE HEARD PAUL SPEAK TO THE COUNCIL ABOUT THEIR IMPORTANT ACTIVITIES MAKING THIS SCIENCE VALID FOR THE STUDY OF DIETARY SUPPLEMENTS WHICH ARE VERY WIDELY USED AND UNREGULATED. WE WERE IN THAT SEARCH, THE DECISION WAS MADE LAST WEEK TO PUT A HALT TO THAT AND FIRST REVIEW THE OFFICE AND ITS ACTIVITIES BEFORE WE REINITIATE A NEW SEARCH. SO YOU WILL HEAL MORE ABOUT THAT. A SPECIAL WELCOME AND NOTICE TO DR. TARA SCHWETZ, OVER HERE IN THE TAN COAT, ASSOCIATE DEPUTY DIRECTOR OF NIH, AND YOU WILL BE SEEING MORE FROM HER. LET ME DESCRIBE WHAT HER ROLE WILL BE. TARA IS GOING TO SERVE AS NIH'S FIRST ASSOCIATE DEPUTY DIRECTOR. SHE STARTED THIS ROLE JUST A FEW WEEKS AGO. AND AS YOU KNOW LARRY TABAK WHO COMES TO SPEAK TO THE COUNCIL EVERY YEAR IS OUR PRINCIPAL DEPUTY DIRECTOR, AND HE ALSO -- WE DESCRIBED HIM AS THE INSTITUTE DIRECTOR FOR THE O-D, QUITE A LARGE ENTERPRISE IN ITSELF, OH IT WAS CLEAR -- LARRY NEEDED ASSISTANCE IN RUNNING THE ACTIVITIES OF THE O.D. AND TARA STEPPED IN WITH LOTS OF RELEVANT EXPERIENCE, WORKED WITH LARRY A FEW YEARS BEFORE GOING TO MULTIPLE LEADERSHIP ROLES AT NIAID, INCLUDING BEING ON THE LEADERSHIP TEAM FOR THE DIRECTOR. SHE STARTED AS AAAS FELLOW HERE AND HAD ROLES IN OTHER INSTITUTES, AND SHE OBTAINED HER Ph.D. IN BIOPHYSICS FROM UNIVERSITY OF SOUTH FLORIDA, AND DID POSTDOCTORAL FELLOWSHIP AT VANDERBILT BEFORE COMING HERE. AND ALSO INCLUDING PEOPLE WHO ARE HERE, YOU KNOW ALL THE OFFICE DIRECTORS OF OUR DPCPSI OFFICES ARE LIAISON MEMBERS OF THE COUNCIL, I'LL ASK THEM TO INTRODUCE THEMSELVES, IF THEY ARE NOT HERE WHO THEY DELEGATED TO REPRESENT THEM. THIS ROOM IS SO BIG, WHERE ARE FOLKS? LET'S START WITH DAVE. >> GOOD MORNING, DAVE -- (INAUDIBLE). >> POSTDOCTORAL FELLOWSHIP AT VANDERBILT. >> GOOD MORNING, JAY RADKE FOR MAUREEN GOODENOW OFFICE OF AIDS RESEARCH. >> GOOD MORNING, SPENCER, DEPUTY DIRECTOR OFFICE 67 RESEARCH WOMEN'S HEALTH REPRESENTING DR. JANINE CLAYTON. >> JOSEPH BEST, ACTING DIRECTOR OFFICE OF DIETARY SUPPLEMENTS. >> DAVID RAY, DIRECTOR OFFICE OF DISEASE PREVENTION. >> KAREN PARKER MINORITY RESEARCH OFFICE. >> BETSY WILDER DIRECTOR OF THE OFFICE OF STRATEGIC COORDINATION. >> RAINA VOLKOFF, OFFICE OF REPORTING. >> THE MOST IMPORTANT INTRODUCTION OF THE COUNCIL MEMBERS. >> GOOD MORNING, I'M TERRY MAGNUSON FROM UNC - CHAPEL HILL. >> KRISTIN ODDLY, BROAD INSTITUTE, I'M A NEW MEMBER. >> CHARLES MOUTON, UTMB, UNIVERSITY OF TEXAS MEDICAL BRANCH. >> BRIAN CALLETTER, WASHINGTON UNIVERSITY SCHOOL OF MED, BOARD OF SCIENTIFIC ADVISORS AT NCI THROUGH JUNE OF THIS YEAR. >> (INDISCERNIBLE) UNIVERSITY OF CALIFORNIA SAN DIEGO, ADVISORY COUNCIL FOR THE NATIONAL INSTITUTE OF MINORITY HEALTH AND HEALTH DISPARITIES. >> PAUL KENNEDY, MOUNT SINAI SCHOOL OF MEDICINE, JUST FINISHED NIAAA COUNCIL, GONE TO NIDA COUNCIL. >> GOOD MORNING, PATTY HERN, UNIVERSITY OF MICHIGAN, NO OTHER COUNCILS. >> ANDY FEINBERG, JOHNS HOPKINS UNIVERSITY, NEW MEMBER, I JUST FINISHED SERVICE LAST YEAR ON THE NIEHS COUNCIL. >> EDITH MITCHELL, THOMAS JEFFERSON UNIVERSITY, AND I'VE COMPLETED MY TERM ON THE CTAC. >> RHONDA ROBINSON BEAL, NEW TO THE COUNCIL, BLUE CROSS OF IDAHO, ALSO NATIONAL ADVISORY COUNCIL FOR NIMH. >> NICK HOROWITZ, ALLEN INSTITUTE. >> GARY CREATESKI. >> LINDA CHANG, NEW MEMBER, SERVING ON NIDA COUNCIL. >> PAUL JOHNSON, EMORY UNIVERSITY, PRIMATE RESEARCH CENTER, NO COUNCIL AFFILIATION, STRONG AFFILIATION WITH ORIP. >> MEGAN O'BOYLE, PHELAN-MCDERMID FOUNDATION, NCATS COUNCIL. >> MICHAEL AIRMORE, UC-DAVIS SCHOOL OF VETERINARY MEDICINE, ORIP PRIMARILY BACKGROUND, ALSO NCI. NOT CURRENTLY SERVING. >> GOOD MORNING, ANN MARIE SIGARESE UVA, FORMER COUNCIL MEMBER. >> MARIA ALSABOS SCIENCE INSTITUTE. >> JEFF VODKIN, UNIVERSITY OF UTAH, NEW MEMBER, COUNCIL FOR GENOME INSTITUTE. >> JEAN SHAFER, WASHINGTON UNIVERSITY IN ST. LOUIS, I'M FORMERLY A MEMBER OF THE NIDDK COUNCIL. >> SUSAN SANCHEZ, UNIVERSITY OF GEORGIA, NEW MEMBER. >> GOOD MORNING, EVERYBODY. FRANZISKA GRIEDER, DIRECTOR OF THE OFFICE OF RESEARCH INFRASTRUCTURE PROGRAM, ONE OF THE OFFICES IN DPCPSI, AND I ALSO SERVE AS THE EXECUTIVE SECRETARY TO THIS COUNCIL. >> AND LET ME GET ONE MORE TRY TO SEE IF BRUCE WILL ACKNOWLEDGE THAT HE'S ON. BRUCE? >> GOOD MORNING. >> OKAY. THANK YOU. PLEASE GO AHEAD. >> SORRY. I'M BRUCE (INDISCERNIBLE) FROM SAN FRANCISCO, NINDS ADVISORY COUNCIL. THANK YOU. >> THANKS FOR BEING WITH US, BRUCE. SO I'D LIKE TO REMIND FOLKS THAT MOST OF THE SESSIONS TODAY ARE OPEN TO THE PUBLIC, INCLUDING THE MEDIA, AND THEY ARE ALSO VIDEOCASTING ALL OF OUR OPEN SESSIONS. SO, I NEED TO TURN IT OVER TO FRANZISKA TO DESCRIBE LOGISTICS FOR TODAY. >> THANK YOU, JIM. SO, MATERIALS FOR THIS MEETING, ALL COUNCIL MEMBERS FROM THE MATERIALS IN THEIR BINDERS, FOR OTHER ATTENDEES MATERIALS CAN BE FOUND THERE ON THE TABLE. I'D LIKE TO REMIND EVERYBODY ON THE COUNCIL THAT YOU ARE SPECIAL GOVERNMENT EMPLOYEES, AND THEREFORE SUBJECT TO THE RULES OF CONDUCT THAT APPLY TO FEDERAL EMPLOYEES. SO TO SPEAK, WELCOME TO THE CLUB. THE RULES AND REGULATIONS THAT APPLY TO ALL OF US ARE EXPLAINING THE REPORT THAT'S ENTITLED "STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXECUTIVE BRANCH" WHICH YOU RECEIVED WHEN WE WERE FIRST APPOINTED TO THE COUNCIL. AT EVERY MEETING, THIS IS IMPORTANT, IN ADDITION TO REMINDING YOU ABOUT IMPORTANCE OF THE ETHICS RULES, WE ALSO LIKE TO REVIEW THE STEPS THAT WE TAKE AND THAT WE ASK YOU TO TAKE TO ENSURE THAT ANY CONFLICT OF INTEREST BETWEEN YOUR PUBLIC RESPONSIBILITIES AND PRIVATE INTERESTS ARE IDENTIFIED AND ADDRESSED. AS YOU KNOW, BEFORE EVERY MEETING, YOU PROVIDE US WITH INFORMATION ABOUT YOUR PERSONAL, PROFESSIONAL AND FINANCIAL INTERESTS. WE USE THAT INFORMATION AS THE BASIS FOR ASSESSING WHETHER YOU HAVE ANY REAL POTENTIAL OR APPARENT CONFLICT. IT'S IMPORTANT THAT THE APPARENT CONFLICTS ARE INCLUDED TOO. THEY COULD COMPROMISE YOUR ABILITY TO OBTAIN -- TO GIVE OBJECTIVE ADVICE TO US ON COUNCIL MATTERS. IF SUCH CONFLICT IS IDENTIFIED, WE EITHER ISSUE A WAIVER FOR YOU OR RECUSE YOU FROM CERTAIN PORTIONS OF THE MEETING. WE OF COURSE ALSO RELY HEAVILY ON YOU TO BE ATTENTIVE DURING THE MEETING AND IF YOU IDENTIFY ANY CONFLICT THAT OCCURS DURING THE MEETING WE WILL ASK YOU STATE AND RECUSE YOURSELF FROM THAT PART OF THE DISCUSSION. ARE THERE ANY QUESTIONS TO ETHICS RULES? ALL RIGHT. AT THE CONCLUSION OF THE CLOSED SESSION, WHICH OF COURSE IS THE BIGGEST PART OF ETHICS AND CONFIDENTIALITY, YOUR SIGNATURE ON THE CONFLICT OF INTEREST CERTIFICATION SHEET, THAT'S THAT DOCUMENT THAT YOU CAN FIND IN THOSE YELLOW FOLDERS, WILL DOCUMENT THAT -- YOU WILL DOCUMENT YOUR LACK OF CONFLICT WITH ANY APPLICATION THAT WAS RAISED FOR INDIVIDUAL DISCUSSION. SO EVERYBODY CAN VOTE AND DISCUSS IN EN BLOC VOTES. YOUR SIGNATURE WILL ALSO DOCUMENT THAT YOU UNDERSTAND AND AGREE WITH THE CONFIDENTIALITY PROCEEDINGS. IF YOU HAVE ANY QUESTIONS ABOUT WHAT I JUST EXPLAINED, RULES OF CONDUCT OR CONFLICT OF INTEREST, OUR COMMITTEE MANAGEMENT SPECIALIST, SANDRA CHERIC, SHE SITS OVER THERE, OR I WILL BE HAPPY TO EXPLAIN OR ANSWER ANY QUESTIONS THAT YOU HAVE. AT THIS POINT I WOULD LIKE TO ACKNOWLEDGE THE LOGISTICS CONTRACTOR FOR COUNCIL OF COUNCILS, THE SCIENTIFIC CONSULTING GROUP, MOST OF YOU WILL ALREADY HAVE MET DENISE HOFFMAN, OVER THERE, PROGRAM MANAGEMENT AND PRIMARY POINT OF CONTACT, MANY MET HER LAST NIGHT AT THE DINNER AND DEFINITELY EVERYBODY MET HER THROUGH E-MAIL. SHE'S JOINED TODAY BY JOHN HARE, WHO SITS AT THE LIGHTS, AND MARK DENNIS, OUTSIDE. YOU'LL FIND THESE INDIVIDUALS EITHER OUT AT THE TABLE OR SOMEWHERE AROUND THE ROOM. A FEW MORE ITEMS. TIME AT THE MEETING IS ALLOTTED TO HAVE DISCUSSIONS BETWEEN COUNCIL AND SPEAKERS, OR RELEVANT NIH STAFF THAT THEY WOULD LIKE TO ADDRESS. HOWEVER, THERE IS LIMITED TIME FOR ANY COMMENTS FROM OTHER ATTENDEES. THE PUBLIC IS WELCOME TO SUBMIT ANY COMMENTS IN WRITING AT THE MEETING. INSTRUCTIONS HOW TO DO THAT IS LISTED IN THE FEDERAL REGISTER PUBLICATION NOTICE THAT WAS PUBLISHED ON DECEMBER 27 WHEN THIS MEETING WAS ANNOUNCED. I WOULD ALSO LIKE YOU TO KNOW OR REMIND YOU THAT THE MINUTES OF THIS MEETING WILL BE PUBLISHED ON THE DPCPSI WEBSITE, AND YOU HAVE A COPY OF THE SEPTEMBER MEETING MINUTES IN THE BACK POCKET OF YOUR FOLDERS. JIM ALREADY MENTIONED FUTURE MEETINGS. TODAY'S MEETING IS OF COURSE THE FIRST ONE FOR 2019. THE TWO NEXT MEETINGS WILL BE IN MAY, ON MAY 17, AND ON SEPTEMBER 6. AND JIM MENTIONED THE LOCATIONS, BEFORE WE CAN GO BACK INTO BUILDING 31 I JUST LEARNED THIS MORNING THAT CONSTRUCTION IS ONGOING AND MAY NOT BE FINISHED ANYTIME SOON, MEANING DEFINITELY NOT 19, PROBABLY NOT NO 2020 EITHER. A REMINDER ABOUT MICROPHONES, TURN THEM ON WHEN YOU SPEAK, IT REALLY HELPS THE TRANSCRIPTIONIST AND NOTE TAKERS IF YOU STATE YOUR NAME BEFORE YOU MAKE A COMMENT OR ASK A QUESTION, SO THANK YOU FOR DOING THIS. ALSO THANK YOU FOR TURNING THEM BACK OFF BECAUSE ONLY SO MANY MICROPHONES CAN BE ON AT ANY GIVEN TIME. A CLOSED SESSION WORKING LUNCH WILL BE HELD FROM 11:45 TO 12:45 TO CONDUCT SECOND LEVEL REVIEW OF GRANT APPLICATIONS IN THIS ROUND. IN ACCORDANCE TO NIH AND FEDERAL POLICIES, ATTENDANCE IS RESTRICTED TO COUNCIL MEMBERS AND RELEVANT NIH STAFF. FOLLOWING CLOSED SESSION WE'LL CONTINUE WITH THE OPEN SESSION AND I ASK EVERYBODY TO COME BACK. HOWEVER, BEFORE THAT WE'LL TAKE THE MEMBERS WHO NEED NEW BADGES TO THE BADGING STATION TO GET NEW BADGES. THE LAST I HEARD IT'S DR. ASEBAL, MITCHELL AND MARTIN. WITH THAT, I WANT TO REMIND EVERYBODY THAT THE LUNCHES WILL BE OUTSIDE, THERE'S A CAFETERIA ACROSS THE HALL FOR THE LUNCH BREAK. AND UNLESS THERE ARE ANY QUESTIONS ON LOGISTICS, I CAN TURN IT BACK OVER TO JIM. >> SO AS USUAL, WE HAVE A PACKED AGENDA. WE NEED YOUR INPUT ON A RANGE OF THINGS TODAY. IN THE MORNING WE'LL HAVE PRESENTATIONS FROM TWO OF OUR OFFICE DIRECTORS ABOUT TWO DIFFERENT TOPICS, FRANZISKA WILL TALK ABOUT THE MID-POINT UPDATE OF THE STRATEGIC PLAN FOR ORIP, WHAT THEY ARE ACCOMPLISHING, WHERE THEY ARE STILL HEADED. IT'S A PREFACE TO THE NEXT STRATEGIC PLAN WHICH WE'LL INVOLVED IN A COUPLE OF YEARS. BETSY WILDER WHO DIRECTS OFFICE OF STRATEGIC COORDINATION IS GOING TO -- I'LL COME BACK TO THIS LATER. MORE DETAILED HOW TO EXPLAIN WHAT WE NEED FROM I SO I'LL COME BACK TO IT. LARRY TABAK, PRINCIPAL DEPUTY DIRECTOR, WILL GIVE AN UPDATE. IT'S A GOOD OPPORTUNITY FOR YOU TO ASK ANY QUESTIONS YOU WANT ABOUT WHAT'S GOING ON HERE OR HOW WE INTERACT WITH THE REST OF THE GOVERNMENT. WE'LL HAVE A GROUP PHOTO FOR COUNCIL MEMBERS AND YOU CAN PICK UP YOUR LUNCH AND HAVE A FEW PEOPLE WHO NEED TO PICK UP THEIR BADGES, OR UPDATE THEIR BADGES. WE'LL HAVE A CLOSED SESSION REVIEW OF GRANT APPLICATIONS, AND IN THE AFTERNOON AGAIN THE THINGS WE NEED FROM YOU ARE THE ECHO CONCEPT CLEARANCE, SO THIS IS A PRESENTATION TO YOU OF A PROPOSAL TO CONTINUE A CURRENT FUNDING PROGRAM. AND I'LL EXPLAIN WHAT THE PROGRAM IS ABOUT AND ASK FOR YOUR APPROVAL OR NOT, OR COMMENTS TO WHETHER TO CONTINUE WITH IT. AND THEN WE HAVE ONE OF THOSE WORKING GROUPS OF OUR COUNCIL, THE SEXUAL AND GENDER MINORITY RESEARCH WORKING GROUP THAT SCOTT AND EDITH MITCHELL SERVE ON, AND KAREN PARKER AND SCOUT WILL PRESENT RECOMMENDATIONS THAT CAME OUT OF A MIDDLE OF THE STRATEGIC PLAN REVIEW, IT'S COMPLICATED HOW WE DO THAT SO I'LL COME BACK TO THE LOGISTICS OF THAT. THEN DAVID MURRAY, ONE OF OUR DIRECTORS, IS GOING TO GIVE A DESCRIPTION OF WHAT THEY HAVE LEARNED ABOUT THE PRIMARY HUMAN PREVENTION RESEARCH FUNDING PORTFOLIO AT NIH AND WHAT IT LOOKS LIKE AND HIS THOUGHTS ON WHAT WE MIGHT DO ABOUT THAT. SO WE'LL START WITH FRANZISKA. >> ALL RIGHT. SO, CAN EVERYBODY HEAR ME OKAY? WELL, GOOD MORNING, EVERYBODY, AGAIN. IT'S DEFINITELY PLEASURE FOR ME TO GIVE YOU AN UPDATE ON THE OFFICE OF RESEARCH INFRASTRUCTURE PROGRAM STRATEGIC PLAN. I REMEMBER VERY WELL WHEN I WAS STANDING HERE AND INTRODUCING THE PLAN, KINDS OF TRYING TO SELL IT TO THE COUNCIL. NOT SELL BUT GET INPUT FROM THE COUNCIL. WE'RE HALFWAY THROUGH AND I'M GOING TO GIVE YOU A LITTLE BIT OF AN IDEA WHERE WE ARE AND HOW WE HAVE COME HERE. BECAUSE NOT EVERYBODY ON THE COUNCIL IS FAMILIAR WITH ORIP AND WITH THE HISTORY, WE HAVE NEW MEMBERS, I WANT TO REMIND EVERYBODY THAT ORIP WAS FOUNDED OR STOOD UP IN DECEMBER OF 2011. I ALWAYS USED TO CLAIM WE ARE THE YOUNGEST CHILD IN THE ORGANIZATION IN DPCPSI WHICH IS NO LONGER THE CASE. THE I STANDS FOR INFRASTRUCTURE, IN ORIP, THAT LED US TO THE MISSION STATEMENT WE HAVE, INFRASTRUCTURE FOR INNOVATION. SO WE SUPPORT RESEARCH INFRASTRUCTURE, AND RESOURCE PROGRAMS, AND OF COURSE VERY MUCH SO IN THE DPCPSI MISSION, WITH A TRANS-NIH FOCUS IN MIND. SO THOSE INFRASTRUCTURES, THOSE RESOURCES, REAL SUPPORT ALL FUNCTIONS, ALL SCIENTIFIC DIRECTIONS THAT THE NIH TAKES. SO THIS IS A TRANS-NIH, TRANSINSTITUTE AND CENTER MISSION. BY MAKING THOSE RESOURCES AVAILABLE, MAKING SURE THEY ARE OF THE QUALITY EVERYBODY WANTS THEM TO BE, WE ALSO SUPPORT PRECISION AND REPRODUCIBILITY OF RESEARCH ACROSS THE NIH. AND BY THEM BEING TRANS, THEY ARE ALSO SHARED IN THEIR MISSION. I'M SHOWING YOU THE PORTFOLIO DESCRIBED PROGRAMS THAT WE FUND. ORIP FUNDS ACTUALLY EXTRAMURAL PROGRAM, OUR STAFF IS RESPONSIBLE FOR THOSE PROGRAMS. THREE MAJOR PARTS TO THE PROGRAMS WE FUND LISTED ON THIS SLIDE. WE'RE UNIQUE IN THAT WE FUND A SMALL BUSINESS PROGRAM, AND IT TRACKS THE PROGRAMS THAT THE OTHERS FUND. (INDISCERNIBLE) I'M GOING IN BACKWARDS ORDER HERE BECAUSE THAT'S HOW I THINK. THE DIVISION OF CONSTRUCTION AND INSTRUMENTS IS LED BY (INDISCERNIBLE) WHO I SAW A MINUTE AGO. OH, SHE MOVED ON ME. OKAY. SHE LEADS THE DIVISION, CONSTRUCTION AND INSTRUMENTS. ON CONSTRUCTION, THERE ARE TWO FUNDING OPPORTUNITIES OPEN RIGHT NOW, A BIG ONE, A DIVISION IN ORIP, COLLABORATES WITH THE NIH CENTRAL AND WITH THE OFFICE OF EXTRAMURAL RESEARCH. I'M GOING TO ADVERTISE A LITTLE BIT, PAR, FOR ANYBODY WHO WANTS TO SUBMIT APPLICATIONS DUE IN EARLY MARCH, SO YOU STILL HAVE A CHANCE TO DO SO, AND SHE AND HER STAFF ADMINISTER THAT PROGRAM. THE SECOND ONE OUT, LIMITED COMPETITION, IT'S IN COLLABORATION. WE DO A LOT OF COLLABORATION IN ORIP, WHICH IS THE OFFICE OF AIDS RESEARCH, OUR SISTER ORGANIZATION. THE SECOND PART OF THE DIVISION OF CONSTRUCTION INSTRUMENT FOCUSES ON INSTRUMENT PART, I'LL TALK MORE ABOUT INSTRUMENTS A LITTLE BIT LATER ON AS WE GO ON. THE BIGGEST IS DIVISION OF COMPARATIVE MEDICINE, STEPHANIE MURPHY WHO SITS OVER THERE, SHE DID NOT MOVE ON ME, WITH HER STAFF MANAGE THE DIVISION OF COMPARATIVE MEDICINE. IN GREEN FIELD THE TOPICS ARE MANAGED AND FUNDED BY THE DIVISION. IN ADDITION TO ANIMAL MODELS, AND ANIMAL RESOURCES, WE ALSO SUPPORT VETERINARY TRAINING. I THOUGHT IT WOULD BE FIT TO GIVE A SHORT OVERVIEW HOW WE GOT TO THE STRATEGIC PLAN THAT YOU ALL HAVE IN YOUR BINDERS, AND ON YOUR WAY BACK YOU CAN READ A LOT ABOUT ORIP'S STRATEGIC PLAN AND A LITTLE BIT MORE ABOUT THE BACKGROUNDS THAN I CAN GIVE YOU IN THESE FEW MINUTES. BECAUSE IT WAS THE VERY FIRST STRATEGIC PLAN FOR AN ORGANIZATION, FOR ORIP, WE STARTED WITH SOME FOCUS GROUPS. THREE FOCUS GROUPS WERE COMPOSED OF MEMBERS OF NIH, SO SOME OF THE COLLEAGUES IN NIH WHO ARE PROGRAM OFFICERS, WE MET WITH THEM IN THREE ROUNDS ABOUT TEN EACH, AND THEY GAVE US INSIGHTS OF ADVICE OF WHAT THEY FELT, WHAT WOULD BE MOST HELPFUL FOR THEIR PROGRAMS IN OUR STRATEGIC PLAN. I THEN PRESENTED THE DRAFT PLANS TO THE EXTRAMURAL PROGRAM MANAGEMENT COMMITTEE, THAT'S THE THE GROUP COMPOSED OF ALL THE DIRECTORS OF EXTRAMURAL PROGRAMS IN EACH OF THE I.C.s. SO I HAD IN INPUT FROM THERE. WE GATHERED INFORMATION FROM THE PUBLIC IN GENERAL. WE HAVE TWO WORKSHOPS WITH STAKEHOLDERS, VERY SPECIFICALLY WHO USE OUR RESOURCES. MANY ARE GRANTEES, SOME WERE ALSO USERS OF OUR RESOURCES. AND WE ENDED UP BY THE COUNCIL PRESENTATION THAT I MENTIONED EARLIER ON. WE HAD TWO COUNCIL MEMBERS APPOINTED AS LIAISONS, TERRY MAGNUSON WAS ONE AND KEITH ROTATED OFF THE COUNCIL. AND ALL THESE EFFORTS RESULTED IN THIS PLAN. THIS PLAN WHICH HAS THREE MAJOR THEMES, THE THEME OF MODELS, THE THEME OF INSTRUMENTATION, AND THE THEME OF TRAINING. AND WHAT I THOUGHT I WOULD DO FOR YOU TODAY IS GIVE YOU A LITTLE INSIGHT IN WHAT WE HAVE BEEN WORKING ON AND CERTAIN THINGS WE HAVE ACCOMPLISHED SINCE THE PLAN WAS LAUNCHED. I'M GOING TO GO IN REVERSE ORDER. SO UNDER THE TRAINING, I MENTIONED THAT ORIP FOCUSES TRAINING ON VETERINARIANS AND VETERINARY SCIENCES SPECIFICALLY. AND IT'S IMPORTANT TO UNDERSTAND THAT IN VETERINARY TRAINING, STUDENTS GET VERY UNIQUE TRAINING. UNIQUE INSIGHT INTO WHAT THE ANIMALS CAN PROVIDE FOR THE RESEARCH SETTING. SO THE INSIGHT THAT THE SCIENTISTS, VETERINARY SCIENTISTS, BRING TO THE ENTERPRISE OF RESEARCH IS QUITE UNIQUE AND IT NEEDS TO BE THE TRAINING WE PROVIDE FOR THEM. IT'S IMPORTANT THAT THE RIGHT MODELS ARE SELECTED AND I THINK THE VETERINARY SCIENTISTS ARE UNIQUELY -- IN A UNIQUE POSITION TO DO SO. THE TRAINING THEN THAT WE HAVE ALREADY LEARNED. IN GIVING THIS SOME THOUGHT, I CAME UP WITH A COUPLE EXAMPLES WHICH WILL DEMONSTRATE WHAT I'M TRYING TO SAY. SO, AS AN INFECTIOUS DISEASE PERSON, I THOUGHT MOST PEOPLE WILL USE MICE TO STUDY FLU, INFLUENZA. WELL, FERRETS ARE A BETTER MODEL BECAUSE IN FERRETS THE PATHOGENICITY AND PATHOGENESIS IS THE SYMPTOMS AS WELL ARE MUCH MORE CLOSER TO DISEASE WE SEE IN HUMANS, SO THAT'S PROBABLE AN INSIGHT NOT EVERYBODY HAS. SECOND EXAMPLE HAS TO DO WITH RATS. RATS DON'T HAVE A GALLBLADDER. SO NOT EVERYBODY KNOWS THAT. OF COURSE JIM KNOWS THAT. IF SOMEBODY STUDIES ANYTHING WHERE GALLBLADDER IS IMPORTANT, RATS IS PROBABLY NOT YOUR FAVORITE MODEL. MALIGNANT TYPE OF HYPERTHERMIA IS A CONDITION THAT TICKS DEVELOP UNDER ANESTHESIA, SOMEBODY THAT DEALS WITH TICKS NEEDS TO KNOW THAT. THAT'S INFORMATION YOU DIDN'T HAVE BEFORE MIGHT BE VERY HELPFUL. ALONG THESE LINES I WANT TO MENTION THAT WE DO IN ORIP, WE CONDUCT SOME STUDIES TO HELP INVESTIGATORS MOVE FORWARD, WHERE THEY WANT TO GO AND UNDERSTAND BETTER WHAT RESOURCES THEY HAVE AVAILABLE. SO THIS YEAR, THIS LAST YEAR, WE CONDUCTED AN ANALYSIS OF NON-HUMAN PRIMATES, COLLECTION OF A LOT OF DATA, WHAT THE SITUATION IS ON HOW MANY ANIMALS WE HAVE, HOW MANY ANIMALS WILL BE USED, AS MUCH AS WE CAN PREDICT IT. AND THERE WAS A CONFERENCE HELD WHERE THIS WAS DISCUSSED. WE HOPE THAT THESE EFFORTS WILL LEAD TO BETTER UNDERSTANDING WHERE WE NEED TO GO. ON THIS SLIDE I'M GOING TO SHOW A LITTLE BIT WHAT WE ARE FUNDING IN ORDER TO SUPPORT EFFORTS I JUST DESCRIBED. SOME EFFORTS HAVE BEEN ONGOING FOR QUITE A WHILE. WHILE OTHERS HAVE BEEN ADDED NEWLY SINCE WE FUNDED OR WE LAUNCHED THE STRATEGIC PLAN. THE FIRST FUNDED MECHANISMS LISTED ARE EFFORTS THAT GO OUT TO EITHER INSTITUTIONS, THE FIRST TWO, OR TO INDIVIDUALS. SO INSTITUTIONS CAN APPLY FOR GRANTS. INSTITUTIONAL TRAINING GRANTS. AND GET VETERINARY STUDENTS OR VETERINARY -- GRADUATED VETERINARIANS WITH STUDENTS AND TRAIN THEM. S AWARDS ARE FOR INDIVIDUALS WHO WORK ON A Ph.D. OR WORK ON A COMBINED Ph.D./DVM DEGREE. K AWARDS, EVERYBODY HAS TO BE A VETERINARIAN, THERE'S NO OTHER PLACE THAT FOCUSES ON VETERINARY TRAINING. THE LAST TWO MECHANISMS LISTED ARE MECHANISMS OR OPPORTUNITIES THAT WE ADDED IN THE STRATEGIC PLAN WAS ACTUALLY PUBLISHED. WE REALIZE K GRANTEES HAVE A HARD TIME SOMETIMES SUPPORTING THEIR RESEARCH BECAUSE THE K AWARD ACTUALLY ONLY FUNDS THEIR SALARY. WE NOW OPENED R01 OPPORTUNITY FOR KO 1 GRANTEES WHILE THEY HAVE THE K 01S AND CAN APPLY FOR TWO-YEAR AWARDS TO FUND RESEARCH TO SUPPLEMENT WHILE THEY LEARNED WHILE STEER IN CAREER TRAINING. AND THEN ORIP'S DIVISION SIGNED UP FOR THE LOAN REPAYMENT PROGRAM, AN IMPORTANT ASPECT FOR VETERINARIANS AND TRAINEES BECAUSE LOTS OF TRAINEES ARE HORRIBLY IN DEBT AND THEY HAVE HUGE LOANS TO PAY BACK. LOAN REPAYMENT PLAN IS A GREAT THING TO HAVE ADDED. I'LL GIVE MORE INFORMATION ON THE K01 AWARD FOR VETERINARY TRAINEES, BRUCE OVERSEES, HE DID ANALYSIS, A LOT OF INFORMATION. PER YEAR WE FUND ABOUT FIVE OF THE K01s, TOTAL OF 20 TO 25 AWARDS, NOT BIG BUT MAKES A DIFFERENCE FOR THE TRAINEES. 70 AWARDS IN A 14-YEAR PERIOD, SO SINCE 2003 AND WHEN WE LOOKED WHAT TRAINING PRIOR TO RECEIVING THE AWARD WE SAW 2/3 OF THEM HAD KEY AWARD OF ONE OR ANOTHER KIND, AND MORE SO FROM THOSE WHO HAD KEY AWARDS, ABOUT 77% ALMOST THE SAME AMOUNT WHO SERVED 3/4 HAD T AWARDS FROM ORIP. WE MAKE T AWARDS AVAILABLE AND THEY GRADUATE AND MANY SECURE K AWARDS THEREAFTER. WE ALSO LOOKED A LITTLE BIT INTO THE LONG-TERM OUTCOME OF OUR TRAINEES, AND OF COURSE IF YOU LOOK LONG-TERM AND WHAT'S TO KNOW WHAT HAPPEN AFTER THEY HAVE THE AWARD WE HAVE TO GO BACK IN TIME. WE LOOKED AT 2003 THROUGH 2011, AND IDENTIFIED 39 K01 AWARDEES IN THAT TIME, AND I'M VERY IMPRESSED THAT 90% OF THEM ARE STILL IN POSITIONS OF RESEARCH, SO WE CAPTURE THEM AND THEY ARE ACTUALLY MAINTAINED IN RESEARCH, IN ALMOST THE NAME NUMBERS, STILL PERCENTAGE, STILL PUBLISH IT. SO THEY ARE NOT KIND OF DOING THIS AND DECIDE THEY DO SOMETHING ELSE. THIS IS KIND OF A LONG-TERM INVESTMENT AND WE CAPTURE THEM FOR THE LONG RUN. MY LAST SLIDE ON THE TRAINING FOCUSES ON A SMALL EXPERT PANEL WE CONVENED LAST SUMMER, CONVENED 22 SCIENTISTS, WITH EXPERTISE IN TRAINING. MANY OF THEM WERE ORIP TRAINEES, TRAINING DIRECTORS, OTHER CAME FROM INTRAMURAL PROGRAM OR OTHER TRAINING DIRECTORSHIPS. AND THEY DISCUSSED WHAT WHAT IS MOST NEEDED, MOST THAT THEY NEED TO RESEARCH SCIENCE, KNOWLEDGE, INFECTIOUS DISEASES, TO REALLY SERVE THE RESEARCH IN WHICH THEY CONTRIBUTE. THEY ALSO FELT STRONGLY IT WOULD BE GREAT TO HAVE BETTER COLLABORATIONS BETWEEN THE VETERINARY SCHOOLS AND MEDICAL SCHOOLS SO VETERINARY SCIENTISTS AND MEDICAL SCIENTISTS WOULD CLOSELY COLLABORATE. AND MIKE AND I HAD AN INTERESTING DISCUSSION OVER DINNER LAST NIGHT, AND I ACTUALLY HEARD INFORMATION THAT MAYBE WE CAN HEAR MORE ABOUT LATER. AND LASTLY, EVERYBODY FELT THAT THERE NEEDS TO BE SOME FOLLOW-UP TO THESE DISCUSSIONS. WITH THAT, LET ME MOVE TO THE SECOND TEAM, INSTRUMENTATION TOPIC, STATE-OF-THE-ART INSTRUMENTATION. WHAT IS ORIP FUNDING? ORIP FUNDS STATE-OF-THE-ART INSTRUMENTATION THAT ONCE AGAIN SERVES TRANS-NIH PURPOSES. THE APPLICATION SAYS CLEARLY AT LEAST THREE INVESTIGATORS NEED TO SHARE INTO SHARED INSTRUMENTS, USUALLY IT'S MORE, USUALLY AVERAGE OF 8 GRANTS THAT ARE LISTED. THERE'S THREE FLAVORS OF THESE AWARDS. THE SHARED INSTRUMENT IS THE LONGEST RUNNING ONE, IT FUNDS APPLICATIONS BETWEEN $50,000 AND $600,000, THE ONE HIGHER IS HIGH END INSTRUMENTATION PROGRAM, SO A LITTLE BIT YOUNGER. IT FUNDS INSTRUMENTS UP TO $2 MILLION. AND NEWEST KID ON THE BLOCK IS SHARED INSTRUMENTATION FOR ANIMAL RESEARCH, THESE ARE INSTRUMENTS REQUESTED FOR INVESTIGATORS THAT GO BEHIND AN ANIMAL BARRIER FACILITY. SO IF YOU NEED SOMETHING IN THE BARRIER FACILITY, YOU CAN APPLY FOR THAT TYPE OF AWARD. THESE ARE ANNUAL AWARDS, ONE-YEAR AWARDS, SO YOU APPLY FOR THEM AND EITHER GET THEM OR DO NOT GET THEM, AND ONE-YEAR AWARD. SO I WANT TO SHARE TO BEGIN WITH TWO PIECES OF INFORMATION WITH YOU. HOW MANY APPLICATIONS DO WE GET AND THEN HOW DO WE FUND THEM. THE FIRST SLIDE I SHOW YOU HOW MANY APPLICATIONS WE GET. I SHOW YOU FOUR YEARS, BETWEEN 2016 AND 2019, AND OF COURSE I COULD ADD 2019 NUMBERS, THESE ARE THE APPLICATIONS THAT HAVE COME IN AND YOU ACTUALLY WILL REVIEW THESE APPLICATIONS IN THE CLOSED SESSION TODAY. SO, IF YOU LOOK AT THE THREE BIGGEST CATEGORIES OR BUCKETS, AS I LIKE TO CALL THEM, IMAGERS, MICROSCOPES AND SPECTROMETERS, YOU SEE MOST APPLICATIONS THERE. AND NUMBERS ARE CONSISTENT ACROSS THE YEARS. SHOW PERCENTAGES BECAUSE OVERALL NUMBER VARIES, PERCENTAGE IS CONSISTENT, AND MANY OTHER CATEGORIES RECEIVE FEWER APPLICATIONS. WHAT DO WE DO WITH THOSE APPLICATIONS? WE FUND ACCORDING TO THE NUMBER OF APPLICATIONS WE RECEIVE. SO FOR THOSE APPLICATIONS WHERE WE SEE MANY MORE APPLICATIONS, WE ALSO FUND MORE AWARDS. AND WE FEEL AS A PROGRAM THAT THIS MAKES GOOD SENSE BECAUSE REVIEW IS OF COURSE DISTRIBUTED ALL ACROSS MANY DIFFERENT STUDY SECTIONS AND SO ANY POSSIBILITIES OF SCORING OUT, AND WE SERVE THE COMMUNITY, RESEARCH COMMUNITY BEST BY THIS APPROACH. WHAT'S ALSO IMPORTANT TO KNOW IS THAT THESE INSTRUMENTS ARE USED BY EVERYBODY ACROSS NIH. SO THIS SHOWS YOU THE PIECHART WHERE WHO ARE THE USERS OF THESE INSTRUMENTS, WHO FUNDS WHICH OF OUR INSTITUTES AND CENTERS OF THE NIH, THAT HAS FUNDED GRANTS, TWO INVESTIGATORS TWO ACTUALLY USE THESE INSTRUMENTS. AND EVERY FUNDING INSTITUTE AND CENTER IS REPRESENTED ON THIS PIECHART. NOT SO SURPRISINGLY THE BIGGER INSTITUTES HAVE A BIGGER PIECE OF THE PIE. THEY AWARD MORE GRANTS AND THEY HAVE THE BIGGER PIECE OF THE PIE. SO THIS SERVES TRANS-NIH PURPOSES. AS THE STRATEGIC PLAN CAME ALONG, LOOKING INTO OPTIONS WHERE ONE COULD MAKE IMPROVEMENTS. HERE IS A PLACE WHERE ORIP STAFF MADE SOME IMPROVEMENTS. I FIRST NEED TO EXPLAIN TO YOU WHAT THE IDEA PROGRAM IS. THE IeDEA PROGRAM IS INSTITUTAL DEVELOPMENT AWARDS, GIVEN TO THOSE STATES ACROSS THE UNITED STATES WHO TRADITIONAL HAVE LOWER SUCCESS RATES AND GET LESS OF THE NIH FUNDS. YOU SEE THE 23 STATES LISTED THERE, PUERTO RICO, THEY ALL QUALIFY FOR IDEA AWARDS. IDEA FUNDS ARE DISTRIBUTED BY NIGMS. STAFF RECOGNIZE THAT ALTHOUGH NON-IDEA STATES, 100% OF THEM MAKE APPLICATIONS FOR THE SHARE OF INSTRUMENTATION PROGRAMS. FOR THE IDEA STATES, LOOK AT THE HISTOGRAM IN 2017, LESS THAN 50% OF THE IDEA STATES SUBMITTED GRANTS. SO WE FELT THAT WAS REALLY NOT A GOOD SITUATION TO BE FACING, SO PROGRAM STAFF ENGAGED WITH NIGMS PROGRAM STAFF. WE HAD LOTS OF DISCUSSIONS WITH THEM. WE STARTED, OUR PROGRAM STAFF STARTED TO PARTICIPATE IN THE IDEA STATE MEETINGS. WE TWEAKED THE FUNDING OPPORTUNITY ANNOUNCEMENT A LITTLE BIT, ADDED MORE INFORMATION THERE, AND OF COURSE NIGMS ADDED SOME FUNDS TO FUND SOME INSTRUMENTS. FOUR INSTRUMENTS HAVE RECENTLY BEEN FUNDED, AND SUCCESSFULLY -- THE SUCCESS IN SECURING APPLICATIONS FROM IDEA STATES IS DEPICTED IN THE GRAPH, WHERE YOU SEE THAT BETWEEN 17 AND 19 INCREASE LESS THAN 50% OF IDEA STATES APPLYING TO ALMOST 80%. IN SUMMARY, THE SHARED INSTRUMENTATION PROGRAM IS IMPORTANT. IT'S POPULAR. PEOPLE LIKE IT. IT'S HIGHLY SOUGHT AFTER. IT'S ALSO NIMBLE BECAUSE IT'S A ONE-YEAR PROGRAM, IT CAN ADJUST, IT CAN MAKE FUNDING DECISIONS EASILY. SO, YES, IT IS TRUE WE FUND, WE GET MOST APPLICATIONS, ONE OF THE LATEST APPLICATION TIMES TYPES IS FOR 3D PRINTING, NOW WE CAN FUND SOMETHING A FEW YEARS AGO WE NEVER WOULD HAVE THOUGHT ABOUT FUNDING. OF COURSE WE SERVE ALL ICs BECAUSE THE NIH WITH THE SHARED INSTRUMENTS. ALL RIGHT. LAST BUT NOT LEAST, ANIMAL DISEASE MODELS, SEVERAL MEMBERS ON THE COUNCIL WHO MIGHT BE MOST INTERESTED IN THIS. SO, IF YOU THINK THESE MODELS -- MOST PEOPLE WILL THING LIKE MICE AND RATS, WHICH FALL UNDER THE VERTEBRATES. BUT I WANT TO POINT OUT THAT WE ALSO FUND INVERTEBRATES, AND FLIES AND WORMS ARE NOT THE ONLY ONES. WE FUND THE SEE SNAIL, THERE'S BEEN AN AWARD, VERY IMPORTANT MODELS, NOT TO SAY THAT VERTEBRATES ARE NOT IMPORTANT, LOOKING AT PERRY AND PAUL. NON-HUMAN PRIMATES PLAY A HUGE ROLE IN WHAT WE DO, MOST RECENTLY MARMOSETS HAVE GARNERED A LOT OF ATTENTION, OTHER MODELS WE FUND A PIG RESOURCE, TO GIVE YOU KIND OF AN IDEA. AQUATIC MODELS ARE QUITE IMPORTANT TOO AND THEY HAVE INCREASED IN POPULARITY AND USE. SALAMANDER IS A GOOD EXAMPLE, SALAMANDER WHICH CAN REGROW LIMBS. FROG, XANEPUS, DIFFERENT FISH SPECIES, ZEBRAFISH IS LISTED, I'LL TALK ABOUT ZEBRAFISH IN JUST A MOMENT A LITTLE BIT MORE. AND ASSOCIATED WITH OUR DISEASE MODELS ARE OTHER GENETIC BIOLOGICAL INFORMATION RESOURCES THAT WE ALSO FUND AND SUPPORT WITH THE MODELS. SO LET ME TELL YOU ABOUT ZEBRAFISH, A PLACE HOLDER FOR ANY OTHER MODELS THAT WE SUPPORT. IF YOU HAVE FUNDED RESOURCE YOU NEED TO BRING IN MODELS THAT ARE WHAT THEY SUPPOSED TO BE AND DISTRIBUTE THEM. LOOK AT ZEBRAFISH INTERNATIONAL RESEARCH CENTER, THAT WAS FUNDED IN 2000, AROUND THERE, USUALLY TAKES A LITTLE WHILE BEFORE THINGS TAKE OFF. WHEN YOU BRING IN MODELS. AND TERRY CAN ATTEST TO THAT, THE SAME THING THE MOUSE RESOURCE, IT TAKES A WHILE BEFORE YOU HAVE A NAME AND THINGS REALLY HAPPEN. AND IT TOOK QUITE A WHILE FOR THAT TO HAPPEN FOR THE ZEBRAFISH RESEARCH, AND THE YEAR OF BIG JUMP HAPPENED WHEN TWO BIG COLLECTIONS WERE BROUGHT IN. THE SANGER COLLECTION WAS BROUGHT IN, IN TWO INCREMENTS, AND BURGESS/LIN COLLECTION BROUGHT INTO THE ZEBRAFISH RESOURCE CENTER. ON THE LEFT SIDE THE LIGHT BLUE LINE IS INDIVIDUALS PER YEAR ADDITION TO CENTER, DARK BLUE LINE IS CUMULATIVE LINES OF ALLELES THE CENTER HAS, CLOSING ON 40,000 ALLELES. ON THE RIGHT SIDE WE SEE THE ACTUAL LINES, WHAT ARE THESE ALLELES TRANSLATED INTO ACTUAL LINES THAT THE ZEBRAFISH HAS ON STAFF FOR DISTRIBUTION TO INVESTIGATORS. I WAS 11,000 LINE, 60,000 LIVE SWIMMING, BUT THAT'S OKAY BECAUSE THE OTHER ONES CAN BE BROUGHT BACK AND CAN BE MADE FOR WHOEVER REQUESTS THEM. I NEED TO MENTION A LITTLE SYMBOL IN THERE. IT'S THIS FIRE THING THAT HAPPENED IN 2014. IN 2014, THE ZEBRAFISH RESOURCE CENTER HAD A FIRE IN ITS QUARANTINE FACILITY. PROBABLY MOST EVERYBODY WILL REMEMBER THERE WAS A FIRE IN 1989 IN A LAB, THESE THINGS DO HAPPEN. RESOURCES NEED TO GARNER AGAINST THESE THINGS, I'LL TELL YOU A LITTLE BIT MORE ABOUT HOW IMPORTANT THAT IS AND SECOND SIDE STORY. THIS LITTLE FIRE, OF COURSE, HALTED ACQUISITION AND DISTRIBUTION OF MODELS FOR ABOUT NINE TO TEN MONTHS. SO, IT HAS THIS PLATEAU IN THE TOTAL ACQUISITION, I DIDN'T WANT PEOPLE TO WONDER WHY THAT HAPPENED. ACQUISITION IS IMPORTANT, DISTRIBUTION IS EQUALLY IMPORTANT. WHAT THIS GRAPH SHOWS YOU IS OVER FIVE-YEAR PERIOD HOW MANY FISH ARE DISTRIBUTED. PER YEAR IT'S ABOUT 120 INDIVIDUAL FISH. YOU SEE THE NUMBERS IF ONE CAN READ THEM. HOW MANY SHIPMENTS TO HOW MANY LABS, AND THE COUNTRIES OF COURSE DEPICT WHAT THE DARK BLUE BAR IS BROKEN DOWN TO IN GREEN AND GRAY, SO THERE'S QUITE A DISTRIBUTION INTERNATIONALLY AS WELL. THE ZEBRAFISH RESOURCE DISTRIBUTION NATIONALLY AND INTERNATIONALLY AND WE SEE A DIP . THIS SLIDE SHOWS A FIVE YEAR PERIOD, NINDS IS COMING OUT ON TOP. THERE WAS A SHIFT, EARLIER IT WAS MORE CHILD HEALTH AND GM, THIS IS SHIFTING A LITTLE BIT, THERE'S MORE NEUROSCIENCE GOING ON WITH ZEBRAFISH. SO THINGS ARE ADJUSTING. I WOULD LIKE TO POINT OUT IN THIS SLIDE, BROWNISH COLOR TO THE RIGHT, INTRAMURAL SCIENTISTS ARE USERS OF THE ZEBRAFISH RESOURCE AS WELL. I ALREADY MENTIONED A CRYOPRESERVATION. EACH ONE OF OUR RESOURCES, NOT JUST THE FISH RESOURCE, IS RESPONSIBLE FOR SERVING RESEARCHERS, MAKING SURE THE FISH IN THIS CASE THAT WAS DISTRIBUTED IS GENETICALLY WHAT IT'S SUPPOSED TO BE, KEEPING ON THE SHELF IS ASSOCIATED WITH RISK SO CRYOPRESERVATION FOR SAFETY AND SPACE REASONS, WORKING WELL, AND WORKING SECURELY, OF COURSE, A MAJOR ISSUE. WHEN I FIRST JOINED THE NIH, THERE WAS GERM CRYOPRESERVATION, IT DIDN'T WORK WELL, THAT'S WORKED HARD WITH RESOURCE CENTER AND OTHER INVESTIGATORS TO IMPROVE CRYOPRESERVATION. THERE WAS A WORKSHOP HELD, THE REPORT WAS PUBLISHED, AND DISCUSSIONS WERE HELD, WHERE THE DIRECTION SHOULD GO FOR FUTURE RESEARCH. NOW, WE ARE ACTUALLY AT THE SPACE WHERE EMBRYOS CAN BE CRYOPRESERVED FOR FISH, THAT MAKES IT POSSIBLE THAT THE STUFF CAN BE FROZEN AND THEY ARE SECURE. WE FUNDED -- WE LAUNCHED NEW FUNDING OPPORTUNITY ANNOUNCEMENTS SO PEOPLE HAVE APPLIED, SBIR AND R01 TYPE, R21 TYPE INVESTIGATION. THE LAST IS CRITICAL IMPORTANCE IN MY OPINION. ORIP STAFF ENGAGED WITH INVESTIGATORS AT THE USDA, THERE IS A GERMPLASM PROGRAM WITH DICK CASE IN COLORADO, WHERE FROZEN STOCKS ARE HELD AT AN OFFSITE. ZEBRAFISH CENTER HAS CRYOPRESERVED SAMPLES STORED THERE SO THIS IS ONE OF THE SAFE SECURITY APPROACHES TO SAFEGUARD AGAINST FIRES OR FLOOD OR WHAT HAVE YOU. SO WITH THAT I'M GOING TO SUMMARIZE AND COME TO AN END AND SEE IF THERE ARE QUESTIONS. WHAT I TOLD YOU TODAY IS NOT WHAT I DID. THIS IS DEFINITELY A MUCH BIGGER ENTERPRISE. I COULD NEVER HAVE DONE OR I COULD NEVER HAVE PRESENTED WHAT I PRESENTED TODAY WITHOUT THE STAFF IN ORIP, DEDICATED AND COMPETENT STAFF. I COULDN'T MENTION EVERYBODY. I COULD NEVER HAVE DONE IT. WE COULD NEVER DO IT IF WE WOULDN'T HAVE NIH COLLEAGUES WHO WORK WITH US. WE WORK INTENSELY WITH OUR COLLEAGUES IN OFFICE OF AIDS RESEARCH, OFFICE OF WOMEN'S HEALTH, DIETARY SUPPLEMENTS, WE WORK WITH THE COMMON FUND. THERE ARE PROBLEMS SHARED WITH THE COMMON FUND. SO WE HAVE CLOSE COLLABORATION. AND MOST IMPORTANTLY, OF COURSE, WE COULD NEVER DO IT WITHOUT OUR GRANTEES. OUR GRANTEES ARE THE ONES WHO REALLY PUT THESE PROGRAMS TOGETHER. I WANT TO REMIND EVERYBODY THAT INFRASTRUCTURE WE SUPPORT AND THESE ARE THE LONG-TERM INVESTMENTS, ANIMAL MODELS, I FOCUSED ON ONE. I FOCUSED ON ZEBRAFISH FOR YOU TODAY, BUT THERE ARE MANY OTHERS, PRIMATE CENTERS HAVE BEEN FUNDED FOR 55 YEARS, WE'RE TALKING LONG-TERM INVESTMENTS. AND OF COURSE ALL OF THOSE PROGRAMS ALSO ENHANCE AND IMPROVE WHAT RESOURCES IN THESE CENTERS DO IN TERMS OF TRAINING OF VETERINARIANS, OF ANIMAL CARE STAFF, AND ALSO IN ANIMAL CARE AND USE PROGRAMS. SO THOSE ARE OF COURSE THE LEADERS IN NOT JUST DEVELOPING BUT PROMOTING THOSE PROGRAMS. THE SHARED INSTRUMENTATION AND CONSTRUCTION ARE EQUALLY IMPORTANT AND SERVE THE COMMUNITY, THE RESEARCH COMMUNITY, AS I SAID MANY TIMES, ACROSS THE INTERESTS OF THE NIH. THE SECOND TO THE LAST BULLET AND LAST BULLET IS THAT I OF COURSE WITH THE STRATEGIC PLAN SOONER OR LATER, THINK MORE SOONER THAN LATER, WE WILL START THE NEXT STRATEGIC PLAN, LAUNCH NEW IDEAS, AND WE WILL COME TO YOU, WE WILL COME TO YOU AS OUR COUNCIL MEMBERS, TO GAIN YOUR INSIGHT, ASK YOU QUESTIONS, WHERE WE SHOULD GO, AND WHAT NEXT STEPS WE NEED AND WHICH DIRECTION WE SHOULD GO WITH OUR PROGRAMS THAT ARE ONGOING. AND WITH THAT, LET ME SEE IF YOU HAVE ANY SPECIFIC QUESTIONS OR COMMENTS. DR. RAMOS? >> THANK YOU VERY MUCH, FRANZISKA. CONGRATULATIONS TO ORIP BEING ONE OF THE STAKEHOLDERS INVOLVED IN THE DEVELOPMENT OF THIS STRATEGIC PLAN. IT'S NICE TO SEE THE OUTCOMES THAT HAVE BEEN ACCOMPLISHED, SO CONGRATULATIONS. TWO COMMENTS AND MAYBE TWO AREAS I'LL FOCUS ON. ONE IS THE DEVELOPMENT OF THE CONTINUUM OF ANIMAL MODELS. I THINK THE CHANCE TO BE ABLE TO LINK THOSE TO HUMAN OUTCOMES, TO SHOW THE VALUE OF WHAT THEY CONTRIBUTE TO EACH AREA RELATED TO HUMAN OUTCOMES, SOME OF COURSE ARE VERY BASIC. YOU KNOW, GENETICS VERSUS THE OUTCOMES. ONE OF THOSE THAT'S MISSING THAT HAS PARALLELS IN HUMAN WITH THE CTSA MECHANISM IS NATURAL ANIMAL MODELS OF DISEASE, AND I'M SPECIFICALLY REFERRING TO THE AMOUNT OF EFFORT BEING PUT INTO CLINICAL TRIALS IN DOGS, WHICH HELP BOTH THE ANIMALS AND THE OWNERS, BUT ALSO HUMAN OUTCOMES, THIS WAS A FOCUS OF A 2015 NATIONAL ACADEMIES WORKSHOP. THERE'S A LOT OF ACTIVITIES. 15 UNIVERSITIES INVOLVED IN A COLLABORATIVE AROUND ONE HEALTH, AND THIS IS LINKED TO ALL THE CTSAs. ONE OF THE MAIN THINGS WE'RE COLLECTING IS THE AMOUNT OF STORIES COMING OUT OF NATURAL ANIMAL MODELS FROM DISCOVERY OF BASIC ELEMENTS OF GENETICS WITH DWARFISM IN BOTH DOGS AND PEOPLE TO CANCER OUTCOMES. SO I'D LIKE YOUR COMMENTS ON THAT. THE SECOND IS THE WORKFORCE ISSUE. AND YOU POINTED OUT THE SUCCESS RATES, AND THAT'S GREAT TO SEE, AND I THINK THAT TIES INTO THE NIH PHYSICIAN-SCIENTIST WORKFORCE REPORT WHICH INDICATED SIMILAR TRENDS IN WHICH THAT HAPPENS. THE THING THAT YOU DIDN'T POINT OUT IS THE VERY LOW PERCENT OF VETERINARIANS WHO ARE FUNDED BECAUSE OF THE NUMBERS ARE ACTUALLY QUITE LOW COMPARED TO WHAT COULD BE TRAINED. SO WHILE THE QUALITY IS VERY HIGH, NUMBERS FUNDED IS QUITE LOW. AND THAT ACTIVITY HAS REALLY BEEN, AGAIN, HIGHLIGHTED AT THE NATIONAL LEVEL WITH THE SCHOLARS PROGRAM WHICH NIH IS VERY -- WE'RE VERY GRATEFUL FOR THE NATIONAL SCHOLARS PROGRAM, AND THERE'S BEEN TREMENDOUS GROWTH IN THAT NATIONALLY AND LINKED UP NATIONALLY AS WELL. MAYBE YOU COULD COMMENT ON THAT. SO WORKFORCE AND THEN ANIMAL MODELS. >> YES, LET ME START WITH ONE HEALTH AND ANIMAL MODELS. YES, I'M VERY AWARE OF THE ONE HEALTH, TO ME THAT'S INCREDIBLY ATTRACTIVE. IT GOES BACK TO PHYSICIANS AND VETERINARIANS WORKING TOGETHER, PHYSICIAN-SCIENTISTS AND VETERINARIAN-SCIENTISTS WORKING TOGETHER. YOU MENTIONED OCCURRENCE OF SPONTANEOUS OR NATURALLY OCCURRING DISEASE MODELS. AND I THINK THAT'S SOMETHING WE CAN LOOK INTO. IT'S A LITTLE BIT HARDER TO FUND OF COURSE, BUT I THINK IT'S DEFINITELY SOMETHING WE NEED TO LOOK INTO. I'M VERY ENTHUSIASTIC ABOUT ONE HEALTH APPROACH, AND BUILDING ON THAT AND WHATEVER WE CAN -- WHATEVER LEVEL WE CAN INTERACT WITH COALITION OF 15 INSTITUTES, I'M DEFINITELY THINKING THAT'S SOMETHING WE NEED TO MOVE FORWARD IN THE FUTURE. ON THE TRAINING AND THE CAREERS, YOU'RE ABSOLUTELY RIGHT, IT'S NOT ALWAYS EASY TO SECURE FUNDING. FREQUENTL, VETERINARY SCIENTISTS ARE MEMBERS OF A TEAM. THERE'S NOTHING WRONG WITH BEING MEMBERS OF A TEAM AND CONTRIBUTING TO A TEAM, BUT IT'S NICE TO SEE YOUNG, PRODUCTIVE, SUCCESSFUL SCIENTISTS ACTUALLY ALSO SUCCEED. AND IT'S ONE OF THOSE THINGS WHERE WE ALL WORK TOGETHER. I MEAN, YOU FROM YOUR END AND WE FROM OUR END, AND I THINK WE HAVE MADE PROGRESS, BUT WE CAN DEFINITELY DO MORE. JIM? >> I WANT TO SAY QUICKLY, WE CAPTURE A TRANSCRIPT OF OUR MEETINGS VERBATIM, AND IT WOULD BE HELPFUL IF PEOPLE WOULD ACKNOWLEDGE WHO THEY ARE FOR THE TRANSCRIPTIONIST. I'M JIM ANDERSON. WE'RE SEEING A PICKUP OF THESE CO-ANIMAL/HUMAN COMPLEMENTARY PROGRAMS, ONE IN THE UNDIAGNOSED DISEASE NETWORK WHICH STARTED AS A CLINICAL CENTER PROGRAM, UNDIAGNOSED DISEASE PROGRAM, WHERE THEY WOULD TAKE PATIENTS IN WHO HAD NEVER HAD A DIAGNOSIS. AND THEY COULD NOT FIND A DIAGNOSIS. AND THEY WOULD APPLY THE WEALTH OF CLINICAL EXPERTISE IN THE CLINICAL CENTER AND USUALLY GENOME SEQUENCING, SOMETIMES FULL GENOME, AND A FAMILY MEMBERS AND OTHER TESTS THAT WE HAVE UNIQUELY IN THE CLINICAL CENTER, AND WE'RE PRETTY SUCCESSFUL GIVING PEOPLE A REASON WHY THEIR CHILDREN OR WHY THEY HAD A PROBLEM. AND SO THROUGH THE COMMON FUND EXTENDED TO UNDIAGNOSED DISEASE NETWORK, WHICH IS MULTIPLE SITES ACROSS THE COUNTRY, WHICH IS BECOMING VERY SUCCESSFUL IN SHARING ACROSS THE SITES, ACROSS THE COUNTRY, EXPERTISE, TECHNICAL ABILITIES, BUILT INTO THAT PROGRAM ARE ANIMAL CORES. SO A MUTANT IN THE HUMAN CAN BE THE NEXT DAY DISCUSSED HOW TO DO THOSE IN ANIMAL MODELS. I DON'T KNOW IF YOU WOULD LIKE TO MENTION OUR EXPERIENCE WITH THE CENTERS THAT CO-FUND HUMAN DISEASE STUDIES ADJACENT TO THE ANIMAL MODELS. >> SO THE PART WHERE I'M -- WE TRIED THAT ONCE, AND IT WAS A LITTLE BIT CHALLENGING. ARE YOU TALKING ABOUT THE PILOT CENTERS? >> THAT'S RIGHT. >> ALL RIGHT. SO SORRY, I WAS THINKING ABOUT SOMETHING ELSE. >> BECAUSE IT IS SOMETHING WE COULD REVISIT WITH THE GROUP NEXT TIME. >> SO, MAYBE I NEED TO CALL ON SOMEBODY ELSE. ORIP FUNDS SO CALLED PILOT CENTERS FOR PRECISION MEDICINE WHERE THERE ARE BASICALLY TWO CLINICS NEXT TO EACH OTHER, THEY CALL THEM THE MOUSE HOSPITAL WHERE THEY TRY TO MIMIC A DISEASE IN A PATIENT, IN A MOUSE MODEL AND TRY TO RUN IN PARALLEL TO GARNER INFORMATION FROM ONE OR THE OTHER. AND WITH OLLIE OR STEPHANIE LIKE TO ADD SOMETHING? I DON'T KNOW. >> I'M OLEG, AN EXAMPLE, THEY REPRESENT VERY GOOD RESULTS. THEY CREATED NEW COLLECTION OF XENOGRAFT MICE FOR ALMOST A THOUSAND PATIENTS, AND THEY CREATED NEW LIBRARIES, TESTED A LOT OF DRUGS, COMBINATION OF DRUGS ON THOSE SAMPLES, DATA DIRECTLY FEEDS TO CLINICAL TRIALS. IT'S A GREAT PROGRAM WHICH WE FUND, WE'RE VERY PROUD OF THIS PROGRAM. AND THEY ALSO CREATED LIBRARY OF KNOCKOUT MOUSE USED AS HOLDERS OF DIFFERENT TYPE OF MUTATIONS, TRIED TO, YOU KNOW, ADDRESS ISSUES OF PRECISION MEDICINE AND SIMPLY ONE OF THE EXAMPLES OF THE VERY SUCCESSFUL PROGRAM WHICH WE RUN. >> THANK YOU. SUSAN? >> I JUST -- SUSAN SANCHEZ, UNIVERSITY OF GEORGIA. I WANTED TO FOLLOW UP ON WHAT DR. LAIRMORE SAID ABOUT NATURAL MODELS OF DISEASE, IT'S NOT CREATING, ANIMALS GET SICK, THEY BELONG TO PATIENTS. BRAIN TUMORS IN DOGS ARE SIMILAR TO THE DISEASE THAT HAPPENS IN PEOPLE. TO BE ABLE TO RECRUIT THOSE PATIENTS AND THEIR OWNERS TO PARTICIPATE IN CLINICAL TRIALS IS VERY DIFFICULT. AND IT COSTS A LOT OF MONEY. YOU ONLY HAVE A FEW PATIENTS AT A TIME. TO GET THE NUMBERS YOU NEED PROVE OF TO PROVE A TREATMENT WORKS IS HARD. HOW CAN WE FIGURE OUT HOW TO SUPPORT AND GET THAT INFORMATION OUT, ANIMALS ARE OWNED BY THEIR OWNERS, IT'S NOT ANIMALS THAT BELONG TO UNIVERSITY FOR STUDIES. THESE ARE COMPLETELY DIFFERENT GROUP OF ANIMALS. SO I THINK THERE HAS TO BE WAYS OF SUPPORTING THE OWNERS OF THE ANIMALS THAT GO THROUGH TREATMENT OR SOMETHING, THERE HAS TO BE A BETTER WAY TO GET OWNERS TO PARTICIPATE IN SOME OF THESE STUDIES. >> THIS IS NOT THE FIRST TIME I HEAR THIS CALL FOR HAVING BETTER ACCESS, HAVING BETTER INFORMATION FROM OCCURRING DISEASE MODELS, WE CLEARLY HEAR YOU. JEAN? >> SO THAT WAS AN EXCELLENT PRESENTATION THAT REALLY HIGHLIGHTS THE TREMENDOUS PROGRESS THAT YOU'VE MADE. I WANTED TO RETURN TO A QUESTION THAT I'VE HEARD DISCUSSED BEFORE REGARDING TRAINING AT THE INSTITUTE LEVEL. CERTAINLY AT NIDDK WE'VE TALKED ABOUT. YOU PRESENTED US SOME INFORMATION ABOUT THE PRE-DOCTORAL TRAINING PROGRAMS, F MECHANISMS VERSUS T MECHANISMS. DO YOU HAVE ENOUGH DATA TO BE ABLE TO COMPARE THE OUTCOMES BETWEEN THOSE TWO PROGRAMS AND CAN YOU COMMENT ON WHAT YOU'VE LEARNED SORT OF FROM YOUR EXPERIENCE WITH THESE TWO DISTINCT PROGRAMS? >> SO, THE T35 PROGRAM IS THE PROGRAM WHERE INSTITUTIONS BRING IN COHORTS OF VETERINARY STUDENTS TO DO SUMMER RESEARCH. THE BEAUTY ABOUT THIS IS THIS HAS GONE ON FOR A LONG TIME, THERE ARE ABOUT TEN SUCH GRANTS WE FUND, EVEN A LITTLE BIT HIGHER NUMBER, EACH GRANT IS IN AVERAGE 10 OR 12 STUDENTS, SO THE NUMBER OF STUDENTS IS ACTUALLY QUITE HIGH. MOREOVER, WE BRING THE STUDENTS TOGETHER. WHEN I WAS A VETERINARY STUDENT IF YOU WANTED TO DO RESEARCH YOU WERE THE OFF GUY. WE BRING THOSE STUDENTS TOGETHER IN THE SUMMER FOR SYMPOSIUM, WHERE THEY PRESENT THEIR RESEARCH, WHICH IS VERY EXCITING OF COURSE FOR THEM. SO THEY CAN TALK TO THE OTHER STUDENTS AND MINGLE WITH THEM. ON THE F SIDE WE HAVE VERY FEW. WE STARTED THAT PROGRAM RECENTLY SO THE INDIVIDUALS WHO GET SUPPORT, AND FOR US THE F 30, THE F30 PROGRAM FOR PRE-DOCTORALS, IS COMBINED PROGRAM SO YOU HAVE TO BE IN VETERINARY SCHOOL, WORK ON A Ph.D. AND F32 GOES TO THE Ph.D., VERY FEW, WE CAN'T MAKE COMPARISON THERE. WHAT WE CAN DO TOO IS LOOK INTO THE P35 STUDENTS, THOSE STUDENTS WHO ACTUALLY DID THAT TRAINING. WHAT I KNOW FROM THE DATA I'VE SEEN LOOKING AT IS ONE IMPORTANT THING, IT SHOWS VETERINARY STUDENTS, WOW, RESEARCH IS REALLY WHAT I WANT TO DO. AND THEN THEY PURSUE THE RESEARCH CAREER OR IT'S NOT WHAT I THOUGHT I WOULD BE DOING AND GO BACK INTO THE CLINIC AND DO WHAT THEY WANT TO DO. DR. LEE FIRST AND THEN I'LL COME BACK. >> THANKS FOR INTRODUCING A LOT OF EXCITING OPPORTUNITIES. I HAVE A QUESTION REGARDING DCI PROGRAM. RELATED TO EXTRAMURAL CONSTRUCTION, MY QUESTION IS WHAT PROJECTS, OR WHAT CONSTRUCTIONS WILL BE ELIGIBLE FOR THIS FUNDING MECHANISM? I'M SURE DR. KLOSIK WOULD ANSWER BETTER BUT I CAN GIVE YOU AN IDEA. SO CONSTRUCTION MEANS BRICK AND MORTAR. YOU ACTUALLY HAVE TO BUILD SOMETHING. YOU CANNOT BUILD SHELF SPACE, AT THE END OF THE CONSTRUCTION IT NEEDS TO BE USED FOR RESEARCH. SO YOU CAN BUILD SECOND FLOOR, YOU CAN ALSO BUILD OUT SHELL FACILITIES, YOU CANNOT BUY EQUIPMENT. YOU CAN BUY -- NOT EQUIPMENT, I THINK IT'S CALLED EQUIPMENT, RIGHT? YOU CAN CONSTRUCT SOMETHING THAT YOU AFTERWARDS CAN DO RESEARCH IN. IT CAN BE A FACILITY TO HOUSE A BIG INSTRUMENT IF YOU HAVE THE INSTRUMENT, IT CAN BE ANIMAL RESEARCH FACILITY, CAN BE BENCH RESEARCH, IT CAN BE SOMETHING WHERE YOU CAN DO RESEARCH. DOES THAT ANSWER? OKAY. THE OTHER THING IS THAT I ALWAYS SAY TO EVERYBODY, READ THE FUNDING OPPORTUNITY ANNOUNCEMENTS, FOA, READ IT MULTIPLE TIME ALSO. >> THIS IS ANDY FEINBERG. THIS IS MY FIRST QUESTION IN SIX YEARS. I'M ACTUALLY NERVOUS THAT IT'S NOT A BAD ONE. IT'S RELATED TO THE IDEA PROGRAM, SO JUST A QUESTION, IT SHOWS MY -- I DON'T KNOW MUCH ABOUT WHAT DPCPSI DOES, ARE SMALL COLLEGES THAT HAVE PERHAPS A FEW OUTSTANDING BIOLOGICAL OR MEDICALLY RELATED SCIENTISTS WHO LIKE TEACHING, YOU KNOW, AND THEY HAVE A CLUSTER OF THEM, ARE THEY ON NIH'S RADAR SCREEN? THEY MIGHT BE AN IDEA STATE AND MIGHT NOT. THOSE PEOPLE CAN HAVE AN ENORMOUS INFLUENCE ON YOUNG PEOPLE WHO HAPPEN TO BE GROWING UP IN THE AREA, LIKE ME ACTUALLY. I WAS INFLUENCED BY PEOPLE LIKE THAT IN CENTRAL PENNSYLVANIA, YOU KNOW, GAZILLION YEARS AGO. >> I DO NOT THINK PENNSYLVANIA IS AN IDEA STATE BUT WE ALWAYS FOCUS ON SMALLER COLLEGES. WE ALWAYS ARE FOCUSED ON THE INSTITUTIONS WHICH ARE NOT RESEARCH INTENSE INSTITUTIONS. WE LIKE TO SEE APPLICATIONS FROM THEM. WE ARE VERY EXCITED WHEN THEY SEND US APPLICATIONS. FOR EXAMPLE, FOR THE SHARED INSTRUMENTATION PROGRAM, I TOLD YOU THERE NEEDS TO BE THREE, NEEDS TO BE THREE NIH FUNDED INVESTIGATORS, UNFORTUNATELY, SO THAT MAKES IT A LITTLE BIT MORE DIFFICULT. BUT THERE ARE OTHER OPPORTUNITIES THAT SMALL COLLEGES MIGHT HAVE. >> I MENTIONED ABOUT THE STATES.- THAT MIGHT NOT BE IDEA STATES BECAUSE SOME SUCH STATES ARE VERY BIG. >> ABSOLUTELY. >> AREAS THAT REALLY ARE NOT CONNECTED TO THE INFRASTRUCTURE. PENNSYLVANIA IS AN EXAMPLE BECAUSE IT'S THE TWO BIG CITIES THAT DOMINATE THE STATE ON EITHER END. AND ACTUALLY LIKE HARRISBURG, THAT AREA, IS ISOLATED. >> UNDER NEW CONSTRUCTION FUNDING OPPORTUNITY ANNOUNCEMENT, ACTUALLY THE DECISION WAS MADE BY NIH TO SET ASIDE 25% OF THE FUNDS AVAILABLE UNDER THAT OPPORTUNITY FOR APPLICANTS WHO COME FROM NOT SO INTENSE RESEARCH BACKGROUNDS FOR THE SO-CALLED INSTITUTION OF EMERGING, SO 25% WILL BE SET ASIDE FOR THOSE APPLICANTS. >> TERRY AND I'LL GO AROUND THAT WAY. >> TERRY MAGNUSON. FRANZISKA, I REMEMBER A COUPLE YEARS AGO THE FUTURE OF ANIMAL MODEL SYSTEMS DATABASES WERE IN QUESTION IN TERMS OF HOW THEY WERE TO BE SUPPORTED AND SO FORTH. HAS THAT BEEN SETTLED? >> ALMOST WANT TO TURN THAT OVER TO JANE, THAT QUESTION. >> THE SUSTAINABILITY OF THE CURRENT MODELS ARE UNDER DISCUSSION. THE WAY WE DONE IT IN THE PAST IS NOT SOMETHING THAT CAN BE SUSTAINED, PROBABLY. IT'S UNDER DISCUSS BY GENOME. I DON'T HAVE A RESOLUTION, IN OTHER WORDS, FOR IT TODAY. >> IT SEEMS TO BE A LONG DISCUSSION. [LAUGHTER] >> I WOULD AGREE WITH THAT COMMENT. >> SO THIS IS GARY KRETSKI. THIS WAS A GREAT PRESENTATION, THESE ARE CRITICAL PROGRAMS. ONE QUESTION I GUESS IN OUR RESPONSIBILITY WITH OVERSIGHT IS THE PIECHART THAT YOU SHOWED, THEY ARE VERY DIFFERENT TYPES OF ENTITIES YOU'RE FUNDING. ARE THE ALLOCATION OF RESOURCES FIXED THROUGH THE STRATEGIC PLAN? ARE THE SUCCESS RATES IN EACH PART OF THE PIE SIMILAR OR IS THIS SOMETHING THAT EACH YEAR CHANGES AS YOU LOOK AT THE APPLICATIONS, JUST AS YOU SAID, YOU KNOW, NOW THERE'S 3D PRINTING THAT DIDN'T EXIST WHEN YOU SET UP THE PROGRAM, AND NOW YOU'RE ABLE TO FUND THOSE. SO DO YOU TRANSFER MONEY BACK AND FORTH AMONGST YOUR GROUPS? >> SO, TWO ANSWERS TO THAT QUESTION. SPECIFICALLY, THE PIECHARTS, SHARED INSTRUMENTATION PROGRAM, SHARED INSTRUMENTS, SO THAT WAS A ONE-YEAR PICTURE. SO THAT CAN CHANGE WHO APPLIES AND WHICH INSTITUTE GETS A BIGGER PART OF THE PIE. SO THAT WILL CHANGE. AS I TOLD YOU, THE MORE APPLICATIONS WE GET FROM ONE AREA, THE MORE WE FUND IN THAT AREA. >> I UNDERSTOOD THAT, BUT BETWEEN DCI AND DCM AND SIBR, DO YOU REALLOCATE SO THAT THERE'S SIMILAR SUCCESS IN EACH OF THOSE BUCKETS? BECAUSE, YOU KNOW, OBVIOUSLY PEOPLE -- WE'RE IN A VERY FAST-MOVING ERA OF NEW EQUIPMENT NEEDS, AND ONE MIGHT IMAGINE THAT THE NUMBER OF APPLICATIONS AND THE INTERESTS IN LARGE AND MEDIUM INSTRUMENTATION WILL GROW. AND IS THERE A CAPABILITY TO BE MORE GENEROUS IF THERE ARE REALLY HIGH-QUALITY APPLICATIONS OR IS THAT A FIXED ALLOCATION? >> IT IS NOT. SO THAT RESPONSIBILITY IN THE END LAYS ON MINE AND DR. ANDERSON'S SHOULDERS IN THE END. I WILL ADD IF FOR WHATEVER REASON WE HAVE AT THE END OF THE YEAR ADDITIONAL MONIES AVAILABLE THEY ARE USUALLY NOT GOING TO A RESOURCE THAT WILL REQUIRE ANOTHER FIVE YEARS OF FUNDING. THEY ALL GO TO SHARED INSTRUMENTATION PROGRAM BECAUSE OF THE FLEXIBILITY. OF COURSE, BALANCING BETWEEN THE TWO, IF ONE AREA REQUIRES LONG-TERM EQUIPMENT WHAT YOU CAN'T JUST SAY, OH, TOMORROW I FEED THESE MONKEYS LESS, YOU KNOW, I CUT YOUR BUDGET IN HALF, IT'S NOT SUCH A GREAT OPTION, AS COMPARED TO MAYBE FUNDING A COUPLE INSTRUMENTS FEWER. SO IT'S A FINE BALANCE AND WE NEED TO LOOK AT IT EACH TIME. BUT NO, IT'S NOT FIXED. >> GARY, THE INSTRUMENT GRANTS ARE ONE-YEAR GRANTS. DIDN'T HAVE ANY OUT-YEAR IMPLICATIONS. >> PAUL? >> TWO QUESTIONS BUT WE'RE GOING TO NEED TO MOVE QUICKLY. BETSY'S PRESENTATION WILL CREATE A LOT OF INTEREST. >> WE CAN MAYBE TALK IN THE BREAK. THANK YOU VERY MUCH. >> THANK YOU VERY MUCH. SO THERE WILL BE MORE TO DISCUSS HERE AS THEY SET OUT GOALS FOR THE NEXT PLAN. SO THE NEXT PRESENTATION IS GOING TO BE GIVEN BY BETSY WILDER WHO DIRECTS THE OFFICE OF STRATEGIC COORDINATION WHICH OVERSEES THE COMMON FUND. BETSY IS GOING TO PRESENT SOME DATA ON THE COMMON FUND HIGH RISK, HIGH REWARD RESEARCH PROGRAMS GOING ON, SOME FOR MANY YEARS, SKIP THE POSTDOC, EARLY INDEPENDENCE IS RELATIVELY NEW, HEAVILY EVALUATED REALLY AS EXPERIMENTS IN HOW TO STIMULATE RESEARCH. SO NO PRELIMINARY DATA IS REQUIRED, IT'S FOR CONCEPTUAL AND SPECIFIC AIMS, MOST AWARDS REQUIRE INTERVIEWS SO THERE'S A NEED TO KNOW ABOUT THE PEOPLE INVOLVED IN THE PROJECT. SOME EVENTS A YEAR AGO CREATED INTEREST IN DISTRIBUTION OF FUNDS, WHICH LED TO CREATION, FRANCIS DECIDED TO CREATE A WORKING GROUP OF THE ADVISORY COMMITTEE TO THE DIRECTOR, TO ADDRESS SOME ISSUES ABOUT THE PROGRAM. THEY ARE DEVELOPING RECOMMENDATIONS FINALIZED IN JUNE I THINK, BRINGING INTERIM RECOMMENDATIONS FOR YOUR INPUT. SO WE WILL CAPTURE WHAT YOU SAY ABOUT THIS AND BRING IT BACK TO THE CO-CHAIRS OF THAT WORKING GROUP, ONE OF WHICH IS LARRY WHO WILL BE HERE LATER TODAY. THAT'S WHAT WE'RE LOOKING FOR FROM YOU, SOMETHING WE CAN BRING TO A WORKING GROUP THAT'S STILL WORKING. BETSY? >> THANKS, JIM. I'D LIKE TO INTRODUCE A FEW KEY PEOPLE BEFORE I GET STARTED, TO THE REPORTS I'M GOING TO RELAY AND THE WORK OF THE PROGRAM. DOCTORS RAVI BAVAKA AND BECKY MILLER ARE PROGRAM OFFICERS FOR THE HIGH-RISK, HIGH-REWARD INITIATIVES IN THE FUND AND DO A CAREFUL JOB ANALYZING THE PROGRAM AND MAKE THOUGHTFUL RECOMMENDATIONS ALL THE TIME. DR. JEFF MAZARUK, THERE YOU ARE, HAS BEEN INSTRUMENTAL IN PUTTING TOGETHER ACD WORKING GROUP AND THE RECOMMENDATIONS TODAY. SO, MY JOB IS TO RELAY TO YOU THE INTERIM RECOMMENDATIONS FROM THIS WORKING GROUP. SO MUCH OF WHAT I'LL PRESENT TO YOU TODAY IS WORK FROM THAT WORKING GROUP. I'M JUST A SPOKESPERSON FOR IT. SO THE AWARD IN THE COMMON FUND IS OUR INVESTIGATOR INITIATED COMPONENT, SO OF THE $600 MILLION PER YEAR THAT WE HAVE IN THE COMMON FUND, ABOUT A THIRD, WELL, 30%, GOES TO THIS PROGRAM. SO IT'S BY FAR THE LARGEST PROGRAM IN THE COMMON FUND. AND THE SCIENCE IS OPEN. ANY SCIENCE THAT FALLS WITHIN THE NIH MISSION COULD POTENTIALLY BE RELEVANT WITHIN THIS PROGRAM. SO EVEN THOUGH ALL OF THE APPLICATIONS ARE SUBMITTED VIA DEDICATED REQUEST FOR APPLICATIONS, THE IDEAS ARE INVESTIGATOR INITIATED. SO THE PURPOSE IS TO ENABLE INVESTIGATORS TO LAUNCH A POTENTIALLY TRANSFORMATIVE PROJECT, WITHOUT PRELIMINARY DATA. SO THERE IS A LOT OF RISK INVOLVED. THE RISK IS MITIGATED IN SOME WAYS BY ENABLING INVESTIGATORS TO HAVE A LOT OF LATITUDE TO CHANGE. SO, WE GET IDEAS, AND PLANS FROM THE INVESTIGATORS IN THE FORM OF AN APPLICATION, HIGH RISK POTENTIALLY VERY INNOVATIVE, FIT DOESN'T WORK OUT THEY HAVE A LOT OF ADJUST TO GO, VERY PRODUCTIVE BECAUSE EVEN THOUGH INITIAL HIGH-RISK IDEAS MAY NOT WORK OUT, THESE INVESTIGATORS USUALLY COME UP WITH SOME REALLY GREAT IDEAS. SO, ALL THE AWARDS ARE FIVE YEARS. AND WE HAVE PILOTED NEW APPLICATION AND REVIEW PROCESSES AS WE'VE GONE. JIM MENTIONED THAT TWO OF THE INITIATIVES WITHIN THE FOUR HAVE INTERVIEWS, THEY ALL HAVE MULTIPLE STAGES OF REVIEWS WHICH WE CAN TELL YOU MORE ABOUT IF YOU'RE INTERESTED. SO THERE ARE FOUR INITIATIVES WITHIN THIS PROGRAM. THE NIH DIRECTOR'S PIONEER AWARDS IS THE OLDEST, LAUNCHED, THE FIRST AWARD GOING OUT IN 2004. THE PIONEER AWARDS ARE OPEN TO ALL CAREER STAGES, BUT WE KNOW THAT THEY -- THIS PROGRAM SELECTS FOR PEOPLE WHO HAVE A HISTORY OF INNOVATION. VERY FOCUSED ON THE PAST ACHIEVEMENTS OF THE INVESTIGATORS AND IT'S SKEWED TOWARDS MORE SENIOR INVESTIGATORS, EVEN THOUGH ANYBODY CAN APPLY. THE NEW INNOVATOR AWARDS ARE FOR EARLY-STAGE INVESTIGATORS. BUT, AGAIN, FOCUSED ON THE PRIOR ACHIEVEMENTS OF THE INVESTIGATORS AND VERY INVESTIGATOR-FOCUSED. TRANSFORMATIVE RESEARCH AWARDS SHARE THE HIGH RISK, HIGH INNOVATIVE GOALS, OPEN TO TEENS. PIONEERS AND NEW. WE ENCOURAGE TEAMS TO GET TOGETHER. THEY HAVE MULTI-DISCIPLINARY EMPHASIS ABOUT THEM AS PEOPLE COME TOGETHER FROM DIFFERENT DISCIPLINES. NEWEST IS EARLY INDEPENDENCE AWARD, AND THESE AWARDS ENABLE PEOPLE WHO ARE JUST FINISHING THEIR DEGREE OR RESIDENCY TO GO INTO AN INDEPENDENT RESEARCH POSITION WITHOUT GOING THROUGH ANOTHER STAGE OF TRAINING. SKIP THE POSTDOC AWARD. GOING FROM TRAINING TO INDEPENDENT POSITION. THESE AWARDS SUPPORT EXCEPTIONAL& WE CREATIVE SCIENTIST WITH POTENTIAL FOR BROAD IMPACT, THAT'S HOW WE DESCRIBE THIS PROGRAM. I WANT TO ELABORATE ON THAT A LITTLE BIT. BECAUSE WITHIN THOSE WORDS, THERE ARE THINGS THEN NOT INCLUDED. FOR ALL COMMON FUND PROGRAMS, WE TRY TO FILL A NICHE, THINGS NOT HAPPENING ELSEWHERE IN THE NIH, AND I THINK IT'S IMPORTANT TO POINT OUT THAT THE INVESTIGATOR INITIATED WORLD OF BIOMEDICAL RESEARCH IS GENERALLY SUPPORTED BY R01s ACROSS THE NIH. IT IS THE BREAD AND BUTTER OF BIOMEDICAL RESEARCH. SO THE NICHE INTENDED TO FILL ARE THINGS NOT GENERALLY SUPPORTED BY R01s. SO A LOT OF RESEARCH REQUIRES THE FOUNDATIONAL PLATFORM OF R01 RESEARCH. THE NEXT HYPOTHESIS BUILDS ON PRIOR HYPOTHESES. AND SO PRELIMINARY DATA ARE CRITICAL FOR R01s. THE NICHE THE COMMON FUND FILLS ARE NEW IDEAS THAT DON'T HAVE THAT PLATFORM. THEY ARE INNOVATIVE. WE DON'T REQUIRE PRELIMINARY DATA. SO, IT'S COMPLEMENTARY TO R01s. AND THAT BROAD IMPACT STATEMENT IS ALSO IMPORTANT TO PLAY OUT. MUCH OF THE R01 PORTFOLIO IS TARGETED TO AN I.C.'S MISSION BECAUSE THEY ARE FUNDED BY I.C.s. RESEARCH FOCUSES ON SPECIFIC CELL TYPE, ORGAN, SPECIFIC CONDITION. WE'RE TRYING AGAIN TO FILL A NICHE NOT WELL SUPPORTED BY THE R01 PORTFOLIO, ENABLING PEOPLE TO DO RESEARCH THAT DOESN'T FIT WELL WITHIN AN INDIVIDUAL INSTITUTE. SO, I POINT THIS OUT, IT WILL BECOME RELEVANT LATER. WE WOULD EXPECT BY DESIGN FOR THE RESEARCH THAT WE SUPPORT FOR THIS PROGRAM TO LOOK DIFFERENT. IT DOESN'T COVER THE SAME TOPICS. OKAY. SO ACD HIGH RISK HIGH REWARD WORKING GROUP IS A FABULOUS GROUP, WONDERFULLY DIVERSE IN TERMS OF CAREER STAGES, A GRADUATE STUDENT, POSTDOC, YOUNG INVESTIGATORS, OLDER INVESTIGATORS, INSTITUTE DIRECTORS, THE WORKING GROUP THAT'S CO-CHAIRED LIE LARRY TABAK AS PRINCIPAL DEPUTY DIRECTOR AND BRENDAN LEE, SCOUT HAS BEEN A MEMBER OF OUR COUNCIL FOR A WHILE, MOLLY CARNES, FORMER COUNCIL OF COUNCIL MEMBER, THIS IS REALLY A FABULOUS WORKING GROUP, THEY HAVE DONE A GREAT JOB PUTTING TOGETHER THESE RECOMMENDATIONS. SO WORKING GROUP IS CHARGED AS FOLLOWS. TOP REVIEW EFFECTIVENESS OF THE NIH HRHR RESEARCH PROGRAMS, FOCUSED ON THE COMMON FUND HRHR PROGRAMS, EVEN THOUGH THERE ARE OTHERS ACROSS NIH. IN PARTICULAR, THE GROUP WAS ASKED TO ANALYZE PARTICIPATION OF WOMEN AND OTHER UNDERREPRESENTED GROUPS. FOR THOSE ON THE COUNCIL A WHILE, A YEAR AGO PROVIDED EVIDENCE THAT SHOWED THAT WOMEN ARE UNDERREPRESENTED IN THE APPLICANT POOLS, AND THEREFORE ALSO IN THE AWARDEE POOLS. SO TRYING TO UNDERSTAND THE CAUSES FOR UNDERREPRESENTATION. OFFER TO LOOK AT INSTITUTIONAL DIVERSITY AND DIVERSITY OF SCIENTIFIC TOPICS IN THE APPLICANT AND AWARDEE POOL. AND THEN FINALLY TO PROPOSE STEPS THE NIH MIGHT TAKE TO ENHANCE THE DIVERSITY OF APPLICANTS AND AWARDEES IN THE HRHR PROGRAM WHILE STILL SUPPORTING THE BEST SCIENCE. SO THE FIRST CHARGE IN TERMS OF ANALYZING EFFECTIVENESS, A WORKING GROUP REVIEWED AN EVALUATION THAT WE PAID FOR A FEW YEARS AGO OF THE PIONEER EVALUATION. THIS EVALUATION WAS CONDUCTED BY THE SCIENTIFIC -- SCIENCE AND TECHNOLOGY POLICY INSTITUTE WITHIN THE INSTITUTE FOR DEFENSE ANALYSIS, AND THIS EVALUATION LOOKED AT THE FIRST THREE YEARS OF AWARDEES FROM THE PIONEER PROGRAM. SO THOSE AWARDEES WHO GOT THEIR AWARDS IN 2004 THROUGH 2006. TO COMPARE THE OUTCOMES OF THOSE RESEARCH AWARDS, EVEN THOUGH NUMBERS WERE QUITE SMALL, TO R01 INVESTIGATORS RESEARCH. SO THEY DID THIS IN TWO WAYS. THEY MATCHED AS CLOSELY AS POSSIBLE THE SCIENCE AND THE INVESTIGATORS BETWEEN R01s AND PIONEERS, SO WE'VE HEARD THAT AS MATCHED INVESTIGATORS. AND THEN RANDOM R01 SETS. AND THEY ALSO COMPARED THE RESEARCH OUTCOMES TO HHMI INVESTIGATORS. SO, THEY ASSESSED THIS IMPACT IN INNOVATION, USED COMBINATION OF BIBLIOMETRICS AND EXPERT INPUT. THE TAKE HOME MESSAGE, PIONEER FUNDED RESEARCH WAS MORE IMPACTFUL AND SIMILAR AND RANDOM R01s, AND ABOUT THE SAME AS HHMI. THEY FOUND THAT THE RESEARCH WAS MORE INNOVATIVE THAN SAME ALREADILY QUALIFIED R01 AND HHMI. WE TOOK THAT INFORMATION. NIH LEADERSHIP DECIDED TO CONTINUE PIONEERS AS INDEFINITE COMPONENT OF THE COMMON FUND EVEN THOSE MOST OF OUR PROGRAMS CYCLE OVER TEN YEARS, THE PIONEER PROGRAM HAS BEEN GOING NOW FOR 15 YEARS. OKAY. WE'VE ALSO DONE A FORMAL EVALUATION OF THE NEW INNOVATOR PROGRAM, AND AGAIN BY THE SAME SCIENCE AND TECHNOLOGY POLICY INSTITUTE GROUP, AND THEY FOUND SIMILAR FINDINGS WITH NEW INNOVATORS. THEY FOUND NEW INNOVATOR RESEARCH WAS MORE INNOVATIVE. IT'S RISKIER. AND IT HAS HIGHER IMPACT THAN R01 RESEARCH FUNDED BY EARLY-STAGE INVESTIGATORS. AND IMPORTANTLY FOR THIS EVALUATION WE WERE ASKING WHETHER WE DO A DISSERVICE TO EARLY-STAGE INVESTIGATORS BY ASKING THEM TO DO RISKY RESEARCH. SO, IF WE ASK FOR THEM TO DO THINGS WITHOUT A LOT OF PRELIMINARY DATA, DOES IT ACTUALLY HARM THEIR CAREER OR IS IT OKAY? THOSE AWARDS DON'T HAVE A NEGATIVE IMPACT, DON'T HAVE A MARKED POSITIVE IMPACT EITHER. IT'S ABOUT THE SAME AS GETTING AN R01. IF AN EARLY STAGE INVESTIGATOR GETS AN AWARD THEY DO PRETTY WELL. OKAY. SO, BUILDING FROM THAT, THE OFFICE OF PORTFOLIO ANALYSIS WITHIN DPCPSI DID ADDITIONAL ANALYSES TO TRY TO GET ADDITIONAL DATA ABOUT THESE AWARDS, IN PARTICULAR LOOKING THE TWO INITIATIVES FOR WHICH WE'VE NOT DONE A FORMAL INITIATIVE, TRANSFORMAL ESEARCH AND EARLY INDEPENDENCE AWARD. THEY LOOKED AT CLINICAL IMPACT OF THESE PROGRAMS AS WELL AS TECHNOLOGICAL IMPACT. CLINICAL IMPACT IS DEFINED AS AWARD THAT YIELDS PUBLICATION THAT IS EITHER CITED IN CLINICAL GUIDELINES OR CLINICAL TRIAL. I'M NOT ABSOLUTELY SURE, IT MAY ALSO BE PUBLICATIONS THAT ARE CITED BY PUBLICATIONS THAT ARE CITED IN THOSE THINGS. I NEED TO CLARIFY THAT WITH THE OFFICE OF PORTFOLIO ANALYSIS. BUT TECHNOLOGICAL IMPACT IS DEFINED AS AWARD THAT YIELDS A PUBLICATION CITED PATENT. OR PATENT APPLICATION. SO THIS IS WHAT WE FIND. FIRST, NIH R01s I THINK RATHER STRIKING FINDING FROM THIS GROUP WAS THAT JUST OVER A THIRD OF AWARDS, NIH R01s, HAVE CLINICAL IMPACT, AS DEFINED BY THOSE CRITERIA. EITHER CITED BY CLINICAL TRIAL OR CLINICAL GUIDELINE. AND THEN ABOUT 16% OF R01s ARE DEEMED TO HAVE TECHNOLOGICAL IMPACT. IF WE LOOK AT SIMILAR MEASURES FOR THE HRHR PROGRAM WE SEE THAT THERE'S NOT A STATISTICAL DIFFERENCE IN TERMS OF CLINICAL IMPACT FOR ANY OF THE INITIATIVES OTHER THAN THE NEW INNOVATORS, WHICH ARE REDUCED IN CLINICAL IMPACT. SO PERHAPS MORE SKEWED TOWARDS VERY BASIC RESEARCH. AND WITH TECHNOLOGICAL IMPACT, THERE'S NO STATISTICAL DIFFERENCE EXCEPT FOR TRANSFORMATIVE RESEARCH AWARDS AND PIONEER RESEARCH AWARDS WHICH HAVE GREATER TECHNOLOGICAL IMPACT. THE SECOND CRITERIA OR SECOND CHARGE FOR THIS GROUP WAS ASSESSING THE PARTICIPATION IN THE PROGRAMS BY WOMEN, AND UNDERREPRESENTED MINORITIES. SO HERE WE HAVE AN INTERESTING SLIDE. SO LET ME JUST REMIND YOU BRIEFLY THAT FOR THESE PROGRAMS THAT GO THROUGH A PHASED REVIEW, WE HAVE APPLICANTS, AND WE HAVE PEOPLE WHO PASS THE FIRST STAGE OF REVIEW, AND THEN WE HAVE -- WE CALL THOSE PEOPLE FINALISTS. AND THEN WE HAVE THE AWARDEES. AND SO WHAT WAS DONE IN THE NEXT FEW SLIDES IS LOOK AT APPLICANTS VERSUS FINALISTS AND AWARDEES. AND THIS SLIDE JUST SHOWS APPLICANTS AND AWARDEES, AND THE PERCENTAGE OF WOMEN IN BOTH POOLS. SO WE CAN SEE THAT FOR PIONEER AWARDS AND TRANSFORMED RESEARCH AWARDS THERE ARE DIFFERENCES, NOT SIGNIFICANTLY DIFFERENT IN TERMS OF THE PERCENTAGE OF WOMEN AND APPLICANT AND AWARDEE POOL. AND FOR NEW INNOVATORS THERE'S INCREASE IN NUMBER OF WOMEN IN AWARDEE POOL. BUT THE EARLY INCENTIVE AWARDS WE'RE SEEING A TROUBLING TREND IN TERMS OF PARTICIPATION OF WOMEN IN THE AWARDEE POOL. AND YOU CAN SEE IN THE APPLICANT POOL, PERCENTAGE OF PEOPLE WHO APPLY TO THESE PROGRAMS IS UNDERREPRESENTED IN WOMEN TO BEGIN WITH BECAUSE CERTAINLY AT EARLY STAGES OF THEIR CAREERS WE'RE GETTING TO ABOUT A PRETTY EQUAL PARTICIPATION OF MEN AND WOMEN IN GRADUATE PROGRAMS AND WE SEE A SKEW AT EACH STAGE. SO, LET ME GET BACK UP ONE SECOND. SO THIS IS AVERAGED ACROSS ALL YEARS OF ALL INITIATIVES. AND THEN WE LOOKED AT 2018 SPECIFICALLY, AND SO I THINK I WANT TO MAKE THE POINT HERE THAT IF YOU LOOK AT ANY INDIVIDUAL YEAR FOR ANY OF THESE AWARDS, IT CAN BE MISLEADING. SO THE NUMBERS ARE SMALL. AND THEY VARY YEAR TO YEAR. SO IN 2018, JUST LOOKING AT THE PIONEER AWARDS, 22% OF THE APPLICANTS WERE WOMEN, BUT 50% WERE WOMEN IN THE AWARDEE POOL. IT WENT UP IN THE FINALISTS AS WELL. AND IF YOU LOOK AT THE EARLY INDEPENDENCE AWARDS, EVEN THOUGH WE SAW THE TROUBLING TREND OVER ALL YEARS, IN 2018, 29% WERE WOMEN, 2018 WE HAD A GOOD YEAR. THIS SLIDE IS MISLEADING IN TERMS OF EARLY INDEPENDENCE AWARD, I APOLOGIZE FOR THAT. IT SHOWS INTERVIEW WAS ELIMINATED. IT WAS ELIMINATED IN 2018 BUT THAT WAS FOR THE 2019 AWARDEES SO WE WON'T KNOW THE IMPACT OF ELIMINATING THE INTERVIEW IN THE EARLY INDEPENDENCE AWARD REVIEW PROCESS UNTIL NEXT YEAR. SO, EVEN THOUGH WE SAW THIS MARKED INCREASE IN PERCENTAGE OF WOMEN IN AWARDEE POOL IN 2018, THEY WENT THROUGH THE SAME REVIEW PROCESS AS THE PRIOR YEARS WHERE WE SAW THIS TROUBLING DECREASE IN THE PERCENTAGE OF WOMEN. SO FOR THE PIONEERS, NEW INNOVATORS AND TRANSFORMATIVE RESEARCH AWARDS WE DON'T SEE PARTICULAR PROBLEMS IN TERMS OF WOMEN IN AWARDEE POOL. FOR THE EARLY INDEPENDENCE AWARDS, THE NUMBERS ARE REALLY SMALL. WE FEEL LIKE WE NEED TO CONTINUE TO MONITOR THIS. AND WE DID ELIMINATE THE REVIEW PROCESS FOR THE 2019 AWARDS, UPON CONSULTATION WITH ALL OF YOU, OR AT LEAST THOSE ON THE COUNCIL AT THE TIME. AND THINKING ABOUT THAT WAS THAT INTERVIEWS MAY POSSIBLY SKEW THINGS AGAINST WOMEN. THERE ARE SOME STUDIES THAT SHOW THAT SO WE ELIMINATED THAT FOR THE 2019 PROCESS. SO WE DO SEE THIS YEAR TO YEAR VARIATION IN PERCENTAGE OF APPLICANTS WHO CHOOSE NOT TO IDENTIFY THEIR GENDER ETHNICITY AND RACE, COMPLICATING THE STUDIES. WHERE WE ARE HERE, IT'S AN ISSUE OF CONCERN, THE NUMBER OF WOMEN AND UNDERREPRESENTED MINORITIES WHO APPLY TO THESE PROGRAMS AND WHO RECEIVE THE AWARDS. THE NEXT ITEM THE WORK GROUP WAS ASKED TO CONSIDER IS INSTITUTIONAL AND TOPIC DIVERSITY. SO THIS SLIDE ADDRESSES TOPIC DIVERSITY WITHIN THE HR HR PROGRAM. IT'S A LITTLE BIT OF A CONFUSING SLIDE I THINK. THE KEY POINT TO MAKE ON THIS SLIDE IS THAT LET ME TELL YOU WHAT UNDERLIES THIS. OFFICE OF PORTFOLIO ANALYSIS TOOK RESEARCH BY THE R01 PORTFOLIO AT THE NIH AND MAPPED IT TO DIFFERENT TOPICS THROUGH VARIOUS TOOLS THAT THEY HAVE. AND LOOKING AT ALL OF THE R01s, THEY DEFINED 148 TOPICS, OR CLUSTERS OF R01s THAT ARE ALIGNED WITH EACH OTHER, WITH RESPECT TO THE TEXT, THE WAY THEY DESCRIBE THEIR RESEARCH. IF DO YOU THAT SAME ANALYSIS WITH THE AWARDS, HIGH RISK HIGH REWARD PROGRAM, YOU SEE OF THE 148 NIH-WIDE CLUSTERS, 21 OF THE CLUSTERS OR 14% OF THE 148 ACCOUNT FOR OVER HALF OF THE APPLICATIONS TO THE HRHR PROGRAM. SO THAT ALONE IS TELLING US THAT THE HRHR PROGRAM AND THE APPLICANT -- SORRY. THIS IS APPLICANTS AND AWARDS ARE SKEWED, RIGHT? SO WE'RE NOT CAPTURING THE WORLD OF NIH RESEARCH TOPICS IN THE HRHR PROGRAM. WE'RE SKEWING. I MADE SUCH A POINT EARLIER ABOUT THIS IS THAT IN MY VIEW WE WOULD EXPECT THIS. WE ASKED FOR IT. WE ASKED FOR THINGS THAT ARE NOT WITHIN THE NIH PORTFOLIO AND I THINK TO A CERTAIN EXTENT THIS IS TELLING US THAT WE'RE GETTING WHAT WE ASKED FOR. THE AWARD RATES FOR EACH OF THE TOPICS IS QUITE VARIABLE. YOU CAN SEE THAT ON THE RIGHT-HAND COLUMN IS AWARD RATE WITH THE TOPICS, HIGHEST AWARD RATE IN DARKER RED, GOING DOWN TO GREEN. AND SO IN THE OTHER COLUMNS IT'S KIND OF MIXED UP. DOES ANYBODY HAVE ANY QUESTIONS ABOUT THIS? IT'S A LITTLE BIT CONFUSING. YOU MIGHT WANT TO DIGEST IT A LITTLE BIT. THE BOTTOM LINE IS REALLY THESE TOPICS ACCOUNT FOR OVER HALF OF OUR APPLICATIONS AND AWARDS. OKAY. SO, LOOKING AT THE INSTITUTIONAL DIVERSITY, ARE WE GETTING APPLICATIONS FROM THE WORLD OF BIOMEDICAL RESEARCH? OR IS THAT ALSO SKEWED? AND WHAT THIS ANALYSIS SHOWS IN BLUE IS THE DATA FROM R01s. AND SO WHAT IT'S TELLING YOU IS PERHAPS A STATEMENT THAT'S A LITTLE BIT OF A FOREGONE CONCLUSION BECAUSE WHAT IT'S SAYING IS THAT THOSE APPLICANT ORGANIZATIONS THAT HAVE THE MOST MONEY GET THE MOST AWARDS. OR GET MORE AWARDS. IN BLUE, THE GRADE OF ORGANIZATIONS THAT HAVE MORE THAN $200,000 PER APPLICANT ARE THE MOST SUCCESSFUL GROUPS FOR R01 INVESTIGATORS. THAT KIND OF MAKES SENSE. IF YOU LOOK IN ORANGE, HRHR ORGANIZATIONS, YOU'LL SEE THAT IS QUITE SKEWED. SO, THE WEALTHIEST, MOST RESEARCH INTENSIVE INSTITUTIONS IN THE NIH COMMUNITY ARE GETTING MORE OF THE AWARDS. SO IT'S SKEWED IN THAT RESPECT. OKAY. LET ME JUST PAUSE HERE BECAUSE THAT'S THE DATA. I'M GOING TO MOVE TO THE RECOMMENDATIONS. DOES ANYBODY HAVE A QUESTION ABOUT THE DATA? YES? >> SO, THIS IS GARY KRETSKI. YOU'VE DONE A GREAT ANALYSIS OF IMPACT. YOU KNOW, AS YOU'RE GOING ALONG. WHEN YOU LOOK AT THESE NUMBERS, IS THERE A DIFFERENCE IN IMPACT, OR ARE THE NUMBERS STILL TOO SMALL? BECAUSE THIS IS A REALLY IMPORTANT SLIDE I THINK. AND HOW YOU'RE DISTRIBUTING THE AWARDS TO PEOPLE AT DIFFERENT INSTITUTIONS, IF YOU'RE IN AN ENVIRONMENT WHERE EVERYBODY'S GOT MONEY, THERE'S ALL THIS STUFF HAPPENING, AND YOU GET ONE OF THESE AWARDS, IS THERE MORE OF AN IMPACT? OR YOU GIVE THIS AWARD TO SOMEBODY IN A LESSER RESEARCH INTENSIVE ENVIRONMENT, DO THEY DO JUST AS WELL? >> THEY DO JUST AS WELL. THANK YOU, EXCELLENT POINT. SO THE ANALYSIS WAS DONE NOT IN THE SAME WAY AS THE PRIOR ANALYSES. IT WAS DONE USING A BIBLIOMETRIC TOOL THE OFFICE OF PORTFOLIO ANALYSIS GENERATED WHICH IS QUITE ROBUST. IT SHOWS ONCE YOU GET THESE AWARDS EVERYBODY -- YOU KNOW, THERE'S NO SKEW. >> YEAH, THIS REALLY SPEAKS TO ONE OF THE RECOMMENDATIONS THAT YOU'RE GOING TO MAKE, AND ACTUALLY DR. FEINBERG'S POINT EARLIER ABOUT PEOPLE AT LOTS OF DIFFERENT PLACES DO PHENOMENAL WORK. >> THAT'S CORRECT. >> AND TRYING TO IDENTIFY THOSE PEOPLE BECOMES REALLY IMPORTANT. >> CAN I ADD A QUICK COMMENT? WE'VE LOOKED AT THE RCR DISTRIBUTION AND MEAN AT OUR TOP FEW AND LIKE THE MIDDLE HUNDREDth, 150th, IT'S VERY SIMILAR. IT TELLS YOU YOU'RE LOOKING AT SO MANY NUMBERS, SUCH A WIDE DISTRIBUTION IN AN INSTITUTION IT'S NOT USEFUL. YOU HAVE TO DO IT WITHIN TOPICS, FOR EXAMPLE. >> YEAH. BUT I THINK THIS IS PARTICULARLY IMPORTANT FOR THESE HIGH RISK AWARDS, THESE ARE INDIVIDUALS WHO HAVE A GREAT IDEA AND THEY CAN BE ANYWHERE. >> THAT'S RIGHT. GREAT POINT. YES. >> I'D LIKE TO FOLLOW UP ON THAT. SO IF YOU -- IN ONE OF THE EARLIER SLIDES, YOU COMPARED THE IMPACT OF R01s, SAID THE IMPACT ARE HIGHER THAN R01s, BUT IF YOU NOW FILTER FOR PEOPLE WHO HAVE HAD STRINGS OF R01s OVER MULTIPLE CYCLES BECAUSE THERE IS A BIAS TOWARDS THE RECORD OR THOSE WHO HAVE 200K+, DOES THAT STATISTIC STILL HOLD UP? SO IN OTHER WORDS, IF YOU UNRANDOMIZED R01s AND INSTEAD START TO TALK ABOUT THE R01s FOR PEOPLE 200K OR OVER, OR PEOPLE WHO HAVE HAD MULTIPLE FUNDING ROUNDS OF R01s, DOES THE IMPACT STILL EXCEED THAT? >> I'M NOT SURE THAT SPECIFIC ANALYSIS HAS BEEN DONE. THE 200K FIGURE IS $200,000 PER APPLICANT AT THAT INSTITUTION, IT'S FOR INTUITION, NOT FOR INDIVIDUAL P.I.S. I SEE BY YOUR FACE THAT'S CONFUSING. IT'S POSSIBLE FOR A P.I. THAT HAS NO RESEARCH FUNDING TO BE INCLUDED IN THAT COLUMN BECAUSE THAT P.I. IS AT AN INSTITUTION THAT HAS MORE THAN 200,000 PER YOUR RESEARCHER. >> I WAS BY THE METRIC, PIONEER AWARDEES, COMPARABLE DATASET, IMPACTS SEEM TO BE HIGHER. YOU CAN INTERPRET THAT YOU'RE DOING A GOOD JOB PICKING PEOPLE WHO HAVE AN IMPACT OR STRUCTURE OF THE GRANT THAT GIVES MORE FREEDOM ALLOWS THEM TO BE MORE IMPACTFUL. DOES THAT SPEAK TO ALLOWING MORE FREEDOM UNDER R01 MECHANISMS? IT'S A BIG QUESTION BUT I'M CURIOUS HOW YOU INTERPRET THAT DATA. >> YEAH, WE INTERPRET IT AS WE'RE GETTING WHAT WE ASKED FOR. SO WE ASKED FOR VERY HIGH IMPACT IDEAS. IDEAS THAT COULD NOT EASILY BE DONE THROUGH AN R01 BECAUSE THERE IS NO BASE OF INFORMATION THAT SUPPORTS THE HYPOTHESIS. OR THEY ARE DEVELOPING AN ENTIRELY NEW TOOL OR WAY OF DOING RESEARCH THAT IS VERY RISKY. AND SO WHEN THOSE IDEAS PAY OFF, YEP, WE GET HIGH IMPACT. AND SO I THINK TO YOUR POINT ABOUT WHETHER WE SHOULD FREE UP R01s, I THINK THAT'S A LEGITIMATE TOPIC FOR NIH LEADERSHIP TO DISCUSS. BUT IT'S IMPORTANT TO REMEMBER THAT THE BREAD AND BUTTER OF RESEARCH BUILDS ON ITSELF, RIGHT? SO YOU TEST HYPOTHESIS, IT LEADS TO NEW HYPOTHESES. YOU GET A RENEWAL ON YOUR GRANT. AND PEOPLE BUILD THEIR CAREERS ON THIS. AND WE HAVE TO DO THAT. SO, YEP, ANDY? >> JUST TO FOLLOW UP ON THAT QUESTION, SO I WAS REALLY STRUCK BY HOW SIMILAR THE RESULTS ARE TO HEDIS FUNDING. I THINK THE PIONEER PROGRAM AT LEAST WAS CREATED, I THINK THE LANGUAGE WAS BACK WHEN I WAS INVOLVED IN IT WAS LIKE (INDISCERNIBLE) OF NIH, AN INVESTIGATOR WITH GREAT IDEAS AS OPPOSED TO SOME GOOD THAT HAPPENS TO HAVE A GOOD INVESTIGATOR. SO ANOTHER METRIC THAT WOULD BE INTERESTING TO LOOK AT, WHAT'S HAPPENING WITH PROGRAMS LIKE THAT, ACROSS THE INSTITUTES. I THINK THE CATALYST AWARD IS BRAND NEW AT NIDDK BUT THERE HAVE BEEN PERSON INVESTIGATED GRANT MECHANISMS, HOW MUCH THEY ARE TARGETED VARIES FROM INSTITUTE TO INSTITUTE, THAT'S ANOTHER SOURCE OF DATA BUT IF OTHER INSTITUTES BUY IN THAT MAY BE ANOTHER WAY OF EXPANDING THE PROGRAM. >> RIGHT, YEP. >> CAN I QUICKLY ADD SOMETHING? WE'RE GOING TO -- I'M SORRY. LARRY WILL BE HERE TO TALK AT 10:30. AND WE JUST HEARD THE DATA. NOW WE NEED TO GET TO THE RECOMMENDATIONS WHICH IS WHAT WE WANT YOUR COMMENTS TO BRING BACK. WE'LL TAKE ONE MORE AND NEED TO MOVE FORWARD. >> THANK YOU. THIS SIDE OF THE ROOM WAS GETTING IGNORED. I HAD A QUESTION RELATED TO EFFECTIVENESS. AND SPECIFICALLY, WHEN YOU'RE LOOKING AT SORT OF THE SUCCESS RATE OF THE INDIVIDUALS AND YOU'RE PRIMARILY FOCUSING ON PUBLICATIONS BUT I THINK IT'S REALLY IMPORTANT TO LOOK AT CAREER ADVANCEMENT, ESPECIALLY FOR THESE INVESTIGATORS WHO ARE EARLY IN THEIR CAREER OR DOING TEAM SCIENCE, SO HAVE YOU HAD AN OPPORTUNITY AND WOULD IT BE WORTHWHILE TO LOOK AT HOW QUICKLY ARE THEY PROMOTED? BECAUSE I REALLY THINK THAT HAS AN IMPACT, AND IT SHOULD BE SOMETHING THAT NIH SHOULD BE CONSIDERING. >> GREAT QUESTION. SO WITHIN THE NEW INNOVATOR EVALUATION WE DID LOOK AT PROMOTION, COMPARED TO SIMILAR ESIs, AND WE DIDN'T SEE A DIFFERENCE. AND SO I THINK MY TAKEHOME FROM THAT IS THAT IF EARLY-STAGE INVESTIGATORS ARE SUCCESSFUL IN GETTING FUNDED, EITHER THROUGH NEW INNOVATOR OR R01, AND THEY TURN THAT AROUND, THEIR CAREERS ARE ADVANCED. SO IN TERMS OF SORT OF TEAMS, IF YOU'RE REFERRING TO THE TRANSFORMATIVE RESEARCH AWARDS, HOW PEOPLE PARTICIPATE IN THOSE MULTI-DISCIPLINARY STUDIES, WE HAVEN'T DONE ANALYSIS. I THINK THAT WOULD BE A REALLY INTERESTING THING TO DO. SO LET ME MOVE ON TO THE RECOMMENDATIONS BECAUSE AS JIM SAID WE WANT TO GET YOUR THOUGHTS ON THESE. SO, THE ACD WORKING GROUP RECOGNIZED THERE'S VALUE IN THESE INITIATIVES. AND THAT THEY ARE HAVING A LOT OF IMPACT, AND THEY WOULD LIKE US TO CONTINUE THAT AND EXPAND IF POSSIBLE. GREAT. THEY HAVE SUGGESTED THAT WE FORMALLY EVALUATE EARLY INDEPENDENCE AWARD AND TRANSFORMATIVE RESEARCH AWARD, WE'VE BEGUN TO SET THAT UP. THE GROUP SUGGESTS THAT OUTREACH COULD BE ENHANCED, THAT ENCOURAGING WOMEN AND UNDERREPRESENTED MINORITIES TO APPLY IS CRITICAL. SO THEY SUGGESTED THAT WE INITIATE A SPECIAL HRHR PROGRAM THAT REQUIRES A COLLABORATION BETWEEN AN UNDERRESOURCED INSTITUTION AND RESOURCED INSTITUTION, AND ADDRESS THIS DIVERSITY IN THE BROADEST SENSE. AND TO TRY TO ENCOURAGE MORE UNDERREPRESENTED MINORITIES TO APPLY. THEY SUGGESTED WE BUILD A CAREER DEVELOPMENT PORTAL THAT CENTRALIZED NIH TRAINING GRANTS AND EFFORTS, AND THERE IS SUCH A PORTAL WITH THE WEBSITE SHOWN HERE. AND IT ALSO SUGGESTED THAT NIH HOST WORKSHOPS, WHERE INSTITUTION CAN SEND ONE TO TWO STUDENTS TO LEARN ABOUT TRAINING OPPORTUNITIES, AND NIH DOES DO OUTREACH LIKE THIS, REFERRED TO AS NIH REGIONAL SEMINARS, AND THEY MOVE AROUND, AROUND THE COUNTRY, TO PROVIDE THAT INFORMATION. NOT ONLY THE STUDENT BUT FACULTY AND TO THE INSTITUTION OFFICIALS AS WELL. ANOTHER RECOMMENDATION IS TO PROVIDE ON THE H.R. WEBSITE PROTOTYPE EXAMPLE GRANTS SIMILAR TO TEMPLATE EXAMPLES AVAILABLE FOR R01, SO WE'LL LOOK INTO DOING THAT. CERTAIN HR HR APPLICATION FEATURES CAN BE APPLIED TO OTHER NIH GRANTS TO ENHANCE BROADER SUCCESS OF UNDERSERVED GROUPS, AND AS AN EXAMPLE THE NEW INNOVATOR FEATURES SHOULD BE APPLIED TO A SPECIAL AWARD TYPE FOR ESI, WHAT THEY ARE REFERRING TO HERE IS NEW INNOVATORS ARE VERY ATTRACTIVE FOR EARLY-STAGE INVESTIGATORS WHO WANT TO GO, WANT TO DEVELOP AN INDEPENDENT RESEARCH PROGRAM THAT DOES NOT DIRECTLY DERIVE FROM THEIR POSTDOCTORAL WORK. AND SO IT'S A PRETTY UNIQUE OPPORTUNITY, AT THE NIH, SINCE OTHER R01s DO REQUIRE THAT FOUNDATION OF PRELIMINARY DATA. SO ONE GROUP IS SUGGESTING THAT THERE BE AN NIH-WIDE MECHANISM THAT WOULD ENABLE PEOPLE, EARLY-STAGE INVESTIGATORS, TO DO RESEARCH THAT DOESN'T DERIVE FROM THEIR EARLIER RESEARCH. RECOMMENDATIONS AROUND BIAS, TOPICS THAT ARE AWARDED UNDERHE- HRHR PROGRAMS, CLINICAL STUDIES TENDING TO UNDERREPRESENTED AS DO BEHAVIOR AND PSYCHOLOGICAL TOPICS. ACD WORKING GROUP IS RECOMMENDING THAT WE CONSIDER A SPECIAL TRACK OR SEPARATE HRHR PROGRAM FOR CLINICAL OUTCOMES WITH THE SEPARATE REVIEW TRACK. AND FOAs FOR ALL HRHR AWARDS, UNDERREPRESENTED TOPICS CAN BE EMPHASIZED, IN THAT LANGUAGE. CONTINUE TO ENSURE REVIEWER EXPERTISE IN TOPICS UNDERREPRESENTED AND AWARD TOPIC MAPS AND MATCHING REVIEWER EXPERTISE TO APPLICATIONS. WE WANT TO MAKE SURE WE HAVE REVIEWERS ON PANEL TO RECOGNIZE APPLICATIONS FROM DIVERSE AREAS AND HIGHLIGHT THOSE WHEN THEY COME IN. WITH RESPECT TO BIAS TOWARDS TOP TIER RESEARCH INSTITUTIONS THE WORKING GROUP HAS SUGGESTED THAT WE CONSIDER ELEVATING INSTITUTIONAL DIVERSITY AS A PROGRAM PRIORITY. SO IN THE FUNDING OPPORTUNITY ANNOUNCEMENTS WE DO CLARIFY THAT FUNDING DECISIONS ARE BASED ON THE REVIEWER SCORES AS WELL AS PROGRAM PRIORITIES WHERE SCIENTIFIC DIVERSITY IS ONE OF THE TOP PROGRAMMATIC PRIORITIES. WE COULD POTENTIALLY INCLUDE INSTITUTIONAL DIVERSITY AS ANOTHER PROGRAMMATIC PRIORITY. THEY ALSO SUGGESTED WE CONSIDER CAPPING THE NUMBER OF APPLICATIONS EACH INSTITUTION CAN SUBMIT. SO, I THINK THAT'S SELF EXPLANATOR, WE ALLOW TWO AND COULD EXTEND TO OTHER INITIATIVES AS WELL. SORT OF DIFFERENT FLAVOR OF THAT WOULD BE CAP THE NUMBER OF APPLICATIONS, NOT INSTITUTIONS, APPLICATIONS EACH INSTITUTION CAN SUBMIT TO FACTOR IN LARGE RANGE OF SIZES, SCALE TO LARGER CAN SUBMIT MORE, SMALLER INSTITUTIONS CAN SUBMIT FEWER. RECOGNIZING AVERAGE REPRESENTATION OF FEMALES IN UNDERREPRESENTED MINORITIES IN APPLICANT POOLS IS REFLECTED IN AWARDEE POOL, AND THERE'S FLUCTUATION FROM YEAR TO YEAR, AND NUMBERS ARE VERY SMALL. THE GROUP AGREES POTENTIAL FOR UNCONSCIOUS BIAS SHOULD BE MITIGATED SO THEY SUGGEST THAT WE CONSIDER REVIEWER EDUCATION OR TRAINING, AND FOR THE PIONEER AND EARLY INCENTIVES AWARD MOVE THE APPROACH REVIEW TO THE FIRST PHASE, AND KEEP ONLY THE BIOSKETCH FOR THE FINAL REVIEW, SO THIS ADDRESSES THE MULTI-PHASE REVIEW PROCESS, FOR THESE AWARDS, AND IN THE MULTI-PHASE REVIEW, THE TECHNICAL APPROACHES ARE CONSIDERED IN THE FIRST PHASE. BUT FOR THE LARGER CONSIDERATION OF HOW THE APPROACH WILL BE CONDUCTED AND WHAT EXACTLY IS GOING ON IS CONSIDERED IN THE INTERVIEW OR TIME PHASE OF THE REVIEW SO THEY ARE SUGGESTING WE MOVE THAT FORWARD. AND THEN REALLY ONLY FOLK FOCUS ON THE BIOSKETCH IN FINAL REVIEW. THE WORKING GROUP ALSO ADDED A LITTLE BIT TO THEIR CHARGE IN CONSIDERING SEXUAL HARASSMENT, AND ARE RECOMMENDING THAT HRHR GRANTEE ORGANIZATIONS PROVIDE ASSURANCES THAT THEY HAVE EFFECTIVE, FAIR AND UP-TO-DATE POLICIES TO PRESERVE HARASSMENT-FREE ENVIRONMENT. AND IF HRHR GRANTEE INSTITUTIONS BECOME AWARE OF HARASSMENT FINDINGS RELATED TO GRANTEES THEY SHOULD ALERT AND WORK WITH NIH TO ARBITRATE THE SITUATION. I THINK THIS IS NOT SOLELY RELEVANT TO THE HRHR GRANTEE POOL, OF COURSE, BUT THEY WANT TO EMPHASIZE FOR THIS AWARDEE POOL. HERE I REALLY LIKE TO GET YOUR THOUGHTS ABOUT THESE RECOMMENDATIONS. ADDITIONS, ADDITIONAL CONCERNS. YES? >> SO DID I HAVE A QUESTION ABOUT THE DATA THAT YOU SHOWED US, AND THEREFORE THE RECOMMENDATION THAT CAME OUT RELATED TO AWARDS BEING MORE PREVALENT AT RESEARCH INTENSIVE INSTITUTIONS. DOES THAT DATA TAKE INTO ACCOUNT NUMBER OF INSTITUTIONS OR ARE THEY GENERATING MORE APPLICATIONS? UP TO THIS POINT THESE ARE NOT BEEN LIMITED OPPORTUNITIES? >> THAT'S RIGHT. SO THAT DATA THAT I SHOWED YOU WAS AWARDS. >> I THINK IT'S REALLY IMPORTANT TO CONSIDER THE NUMBER OF APPLICATIONS AS A DENOMINATOR BECAUSE OTHERWISE, YOU KNOW, I THINK IT'S POSSIBLE YOU COULD SORT OF LOSE EFFECTIVE APPLICATIONS AND POTENTIALLY LOSE UNDERREPRESENTED GROUPS THAT COULD BE COMING FROM LARGER INSTITUTIONS. MY SECOND POINT THAT I ACTUALLY WANTED TO MAKE WAS I THINK ONE MUST BE MINDFUL WITH REGARD TO LIMITED OPPORTUNITIES AND WHILE LIMITED OPPORTUNITY APPLICATIONS COULD POTENTIALLY HAVE UNINTENDED CONSEQUENCES TOWARD NOT HELPING US GET OVER THE ISSUE OF PERCEIVED BIAS AND HOW THESE AWARDS ARE MADE BECAUSE I THINK THAT DIFFERENT INSTITUTIONS HAVE DIFFERENT KINDS OF PROCEDURES FOR ADVANCING OR SELECTING AND ADVANCING CANDIDATES AND I THINK THAT WILL COME INTO PLAY AS ONE MOVES TO A LIMITED OPPORTUNITY. >> YEP, THANK YOU. GREAT COMMENTS. LET ME MOVE TO THIS SIDE OF THE ROOM. I DON'T WANT TO BE BIASED TOWARDS THE LEFT. YES? >> WELL, CHARLES MOUTON. I SUPPORT SOME OF THE THINGS IN SLIDE 17 AND 18, I WAS THINKING ABOUT STRATEGIES, THOSE ARE THINGS THAT CAME TO MIND. I WOULD SUGGEST A COUPLE THINGS. PARTICULARLY, AS YOU THINK ABOUT THE EXPANDED SCOPE, THINKING ABOUT THE SOCIAL BEHAVIORAL CONSEQUENCES AND YOU HAVE THAT UP THERE, SO SOMETHING THAT SPECIFICALLY ADDRESSES THAT BUT EVEN MAYBE BROADER TO COMMUNITY-BASED INTERVENTIONS. AND SOME OF THE INTERVENTIONS THERE, BECAUSE WE SEEM TO DO A REALLY GOOD JOB PARTICULARLY LOOKING AT THE SKEWNESS OF THE CURRENT APPLICANTS AND ADDRESSING SOME FOUNDATIONAL AND BASIC SCIENCES, BUT THAT FULL TRANSLATIONAL SPECTRUM, THIS END, WE PROBABLY NEED TO ENCOURAGE. I SUSPECT YOU'RE GOING TO GET MORE ROBUST DIVERSE POOL WHEN YOU DO THAT AS WELL. THE SECOND PIECE, I'M STILL A AND REVIEW PIECE. YOU TALKED ABOUT THE FINAL PHASE, I THINK IT'S A GOOD IDEA TO TRY SOME OF THE INDIVIDUAL PIECES, BUT THE FACT THAT THE REVIEW STILL LOOKS AT OR SOUNDS THE ENVIRONMENT, THAT THE INVESTIGATORS ARE GOING TO BE CONDUCTING RESEARCH IN IS BY NATURE ALWAYS GOING TO BIAS TOWARD WELL-FUNDED LARGE INSTITUTIONS AND MAYBE LOSE SOME OF THE RICHNESS AROUND THE INNOVATION YOU'RE SEEKING TO ACCELERATE. >> I THINK THAT'S A GREAT POINT. IT IS IMPORTANT TO POINT OUT THAT THE REVIEW CRITERIA ARE MANDATED BY STATUTE, SO IT'S NOT SOMETHING WE CAN EASILY CHANGE. WE DO HAVE TO CONSIDER RESEARCH ENVIRONMENT. BUT I THINK IT'S IMPORTANT TO THINK ABOUT, YOU KNOW, HOW TO DO THAT IN THE BEST POSSIBLE WAY. YES? >> THIS IS HAPPY ANETTA. MY FIRST QUESTION IS ABOUT DATA PRESENTED WHICH EMPHASIZED TRENDS JUST IN WOMEN ALTHOUGH CONCLUSIONS SUGGEST THERE WERE NO DIFFERENCES WITH THE WOMEN AND UNDERREPRESENTED MINORITIES. DID THESE TRENDS -- THIS ANALYSIS, WERE THEY CONDUCTED SEPARATELY FOR UNDERREPRESENTED MINORITIES? THE SECOND HAS TO DO WITH CONCERN WHY ARE PEOPLE ELECTING NOT TO REPORT RACE, ETHNICITY OR GENDER WHO MIGHT THOSE PEOPLE BE, ARE THEY SUSPECTING THERE MIGHT BE BIAS GOING ON IF THEY ARE UNDERREPRESENTED MINORITIES, OR ASIANS, PERHAPS. FINALLY WHEN IT COMMENTS TO HARASSMENT I APPLAUD STATEMENTS LAST FALL ABOUT AVOIDING SEXUAL HARASSMENT BUT IF IS THERE ANY CONSIDERATION ABOUT AVOIDANCE OF RACE AND GENDER HARASSMENT INCLUDING MICROAGGRESSIONS? >> GREAT QUESTION. SO, THE NUMBERS OF UNDERREPRESENTED MINORITY APPLICANTS IS HINEY, SO ANALYSES WERE DONE SEPARATELY, WE DIDN'T PRESENT THEM, HERE THE NUMBERS ARE SO SMALL, PARTICULARLY FOR THE NEWER INITIATIVES, EARLY INDEPENDENCE AWARDS LAUNCHED IN 2009 NOT SURE WE CAN MAKE MEANINGFUL CONCLUSIONS ABOUT THAT RIGHT NOW. YOUR QUESTION, I THINK I'M MISSING ONE, BUT JUST ANSWERING THE QUESTION ABOUT HARASSMENT AGAINST MINORITIES, I DON'T KNOW THAT THERE IS AN NIH-WIDE APPROACH TO THAT. I WILL LOOK TO JIM TO SEE IF YOU'RE AWARE OF THAT KIND OF CONVERSATION ELSEWHERE. >> WELL, IT'S MORE RECENTLY FOCUSED ON SEXUAL HARASSMENT AND ITS IMPLICATIONS FOR CAREER DEVELOPMENT PARTICULARLY. THIS IS AN AREA OF VERY ACTIVE INVESTIGATION BECAUSE OF OUR DIVERSITY OFFICE NOW WITH HANNAH VALANTINE WHO IS ON THE GROUP, AND ALSO AN ACD WORKING GROUP HAS RECENTLY PROVIDED SOME RECOMMENDATIONS ON WHAT WE DO. I DON'T WANT TO GET INTO IT BECAUSE IT SOUND LIKE A COPOUT BUT ONE OF THE THINGS WE'RE FACING IS THAT NIH DOESN'T HAVE THE TYPE OF POLICING AUTHORITY THAT OTHER AGENCIES DO. WE CAN'T MARCH IN AND DO THINGS. WE'RE RESEARCH FUNDING, BUT WE MAKE PROGRESS. AND I'M GOING TO LEAVE IT AT THAT. >> YOUR QUESTIONS? >> AVOIDANCE OF IDENTIFYING RACISM. >> RIGHT. WE DON'T HAVE VERY GOOD INSIGHT INTO WHY PEOPLE ELECT NOT TO PROVIDE THAT DATA. THEY DO IT FOR NOT SPECIFICALLY THESE APPLICATIONS BUT THEY ON THEIR OWN RESEARCH PROFILE. SO WE GET THE INFORMATION FROM THE APPLICANT'S RESEARCH PROFILE THEY PROVIDE FOR NIH-WIDE APPLICATIONS. YEAH, SO WE DON'T HAVE MUCH INFORMATION BEYOND THAT. YES? >> JEFF BOTKIN. I WANT TO EMPHASIZE THE PRIORITY OR NEED TO EXTEND THESE OPPORTUNITIES BEYOND THE TRADITIONAL BENCH, BASIC SCIENCE, AND THOSE ARE THE DATA YOU PRESENTED, REALLY SEEMS EXCLUSIVELY FOCUSED BUT THE INTENT IS NOT BE THAT NARROWLY FOCUSED, SEEMS THERE'S CHALLENGES WITH DEFINING HIGH RISK, HIGH REWARD IN SOCIAL SCIENCE, LEGAL DOMAINS, ET CETERA. BUT THEN ALSO PROBABLY THE BIGGER CHALLENGE IS HOW TO EFFECTIVELY MARKET TO THOSE COMMUNITIES OF SCHOLARS, I DON'T KNOW HOW MUCH THOUGHT IS GOING INTO THAT BUT SEEMS THERE NEEDS TO BE A REAL EFFORT TO LET FOLKS KNOW THESE OPPORTUNITIES ARE THERE. >> YEAH, SO WE HOPE TO WORK CLOSELY WITH OUR COLLEAGUE BILL RILEY TO DO A BETTER JOB OF REACHING OUT TO THAT COMMUNITY AND THINKING ABOUT THESE CRITERIA, WHAT DEFINES HIGH RISK, HIGH REWARD, HOW MIGHT WE REACH OUT TO THAT COMMUNITY MORE EFFECTIVELY. LET ME MOVE TO THIS SIDE. ANDY? >> THE ISSUE ABOUT LIMITING THE APPLICATIONS, SO I ACTUALLY WANT TO DISAGREE WITH THAT FOR A COUPLE REASONS. ONE IS THAT THE DATA THEMSELVES SHOW THAT THE PROBLEM IS GETTING PEOPLE TO APPLY IN THE FIRST PLACE, AND SO THE WAY TO ADDRESS THAT IS TO ENCOURAGE AND DO OUTREACH TO GET PEOPLE TO APPLY. AND I THINK THAT AS A FORMER PIONEER PERSON I USED TO DO THAT ACTUALLY, ALTHOUGH I DIDN'T TELL YOU GUYS ABOUT IT, BUT I WOULD BE ASKED TO TALK TO PEOPLE AT DIFFERENT SETTINGS ABOUT WHAT THE PROGRAM IS AND TRY AND ENCOURAGE PEOPLE, PARTICULARLY PEOPLE WHO THOUGHT THEY WOULD NEVER HAVE A CHANCE. AND EVERY ONE OF THOSE REQUESTS WAS FROM A WOMAN. AND SO I THINK THAT THE PEOPLE THEMSELVES ARE INTERESTED, AND YOU COULD RECRUIT THEM TO DO THIS. THE OTHER IS THAT I THINK IT MIGHT BE A MISTAKE IN TERMS OF INCENTIVES BECAUSE IF THE INSTITUTION IS GOING TO PICK THE PEOPLE FIRST, THEY ARE REALLY DIFFERENT IN WHAT THEY WANT THAN THE BOARD OF SCIENTIFIC REVIEWERS WHICH DEALT WITH THESE BEFORE WHO ARE REALLY LOOKING FOR CREATIVE THINGS, AN INCREDIBLY INTERESTING BODY THAT'S EXTREMELY DIVERSE. AND THE INSTITUTIONS HAVE THEIR OWN PAROCHIAL INTERESTS NOT NECESSARILY ALIGNED WITH WHAT THIS PROGRAM IS ABOUT, UNLIKE CONVENTIONAL GRANTS. >> I'M SEEING NODDING AROUND THE TABLE. YES? >> I WOULD LIKE TO MAKE A COMMENT AND ASK A QUESTION. MY COMMENT RELATES TO THE INTERVIEW. YOU KNOW, THE NUMBERS ARE STRIKING. AND THAT'S -- I UNDERSTAND THE URGE TO MITIGATE THAT DROP-OFF AND GETTING RID OF THE INTERVIEW MAY BE HELPED. THE OTHER MECHANISM OF COURSE IS TO TRAIN REVIEWERS BECAUSE I PERSONALLY THINK THAT INTERVIEWS ARE INCREDIBLY IMPORTANT ESPECIALLY WITH JUNIOR PEOPLE WHO MAY NOT HAVE A TRACK RECORD. AND THE QUESTIO IS EVERY INSTITUTION IS DOING UNCONSCIOUS BIAS TRAINING, SOME PROBABLY DO IT WELL, SOME PROBABLY DO IT DO WE HAVE DATA AND IS THERE A WAY TO ACTUALLY MITIGATE THAT BIAS BY APPROPRIATE TRAINING? I JUST HOPE THAT'S BEING CONSIDERED SO THE INTERVIEW COULD BE RETAINED. MY QUESTION IS ABOUT THE CLINICAL RELEVANCE, AT LEAST AS ONE DOMAIN THAT'S MISSING. AND THAT IS THE PERCENTAGE OF PHYSICIANS WHO ARE APPLYING VERSUS NON-PHYSICIANS AND BEING AWARDED. IF YOU KNOW THE ANSWER TO THAT, BECAUSE I REMEMBER WHEN EARLY INDEPENDENCE AWARDS FIRST CAME OUT IT WAS STRIKING HOW FEW PHYSICIANS WERE BEING AWARDED. I DON'T KNOW WHETHER THAT DATA HAS CHANGED. BUT I DO THINK THAT THAT COLORS THE TYPE OF RESEARCH THAT WILL BE DONE. >> THANKS FOR THAT QUESTION. I'LL TURN TO ROBBIE AND BECKY TO SEE IF YOU KNOW THE ANSWER TO THAT BECAUSE I DON'T KNOW THE BREAKDOWN BETWEEN M.D.s AND NON-M.D.s. A LOT OF M.D.s DO BASIC RESEARCH SO NOT NECESSARILY CLINICAL. RAVI, DO YOU KNOW? CAN YOU GO TO THE MICROPHONE PLEASE? >> I DON'T HAVE THE ACTUAL NUMBERS, BUT WE HAVE LOOKED AT THE NUMBERS OF M.D.s AND Ph.D.s APPLYING, THEY SEEM TO BE AS SUCCESSFUL AS PhDs, THEY SEEM TO BE AS SUCCESSFUL AS M.D.s AND PhDs. >> YES? >> NON-RESEARCH, THIS IS GOING TO BE SOMEWHAT OF A NAIVE QUESTION, BUT ARE THERE PROGRAMS, TRAINING PROGRAMS, SPONSORED BY NIH EITHER WEBINARS OR I'M SURE THERE'S THINGS ONLINE TO EDUCATE THESE YOUNG STUDENTS ABOUT WHAT DIFFERENT TYPES OF AWARDS THERE ARE AND SOME OF THE SPECIALTY AWARDS, OR IS IT UP TO THE INSTITUTIONS TO TRAIN THEIR OWN STUDENTS? JUST SEEMS TO BE SO MANY -- >> THERE ARE A LOT OF TRAINING MECHANISMS ACROSS THE NIH. THEY ARE THE COMMUNITY OF NIH STAFF WHO TRY TO DO A REALLY GOOD JOB OF INFORMING THE TRAINEE COMMUNITY ABOUT WHAT THE OPTIONS ARE AS THEY MOVE FORWARD. FOR OTHER PROGRAMS, WE PARTICIPATE IN THESE REGIONAL SEMINARS, SO THAT WE CAN TRY TO REACH PEOPLE AROUND THE COUNTRY TO PROVIDE INFORMATION ABOUT THEM. AND WE'VE ALSO TRIED TO PROVIDE INFORMATION TO THE OFFICE OF EXTRAMURAL RESEARCH, AT THE NIH, SO THAT THEY CAN GET THAT INFORMATION OUT AS WELL. >> JUST TO ADD THIS, WITH PCORI WHEN NEW AWARDS COME OUT THEY OFTEN HAVE A TOWN HALL WEBINAR WHERE THEY, YOU KNOW, GIVE THE RULES FOR THE AWARD BUT ALSO ALLOW FOR QUESTIONS WHEN THEY SUBMIT AN FAQ. >> WE DO THAT. FOR EACH OF OUR INITIATIVES WE HOLD WEBINARS TO HELP PEOPLE UNDERSTAND WHAT THE APPLICATION RULES ARE, WHAT THE REVIEW PROCESS IS. RHONDA? >> FIRST TIME, FORGIVE ME IF THIS SOUNDS LIKE A STUPID QUESTION TO ASK. I KNOW THERE HAS BEEN SOME CONCERN BY NIH, NIMH, ON THE FACT YOU FUNDED A LOT OF RESEARCH, AND A VERY -- THERE WAS A NOTICEABLE DECREASE OR LACK OF SUBMISSIONS FOR PUBLICATIONS ON THAT RESEARCH WHICH IMPLY THERE WAS RESEARCH BEING FUNDED WITHOUT PUBLICATIONS RESULTING OUT OF THAT. ONE OF THE ISSUES THAT CAME UP IS THAT WHEN ONE DOES RESEARCH AND IT'S NOT SUCCESSFUL, THAT SUBMITTING PUBLICATIONS DOES NOT GET REVIEWED, DOESN'T GET PUBLISHED. SO I GO BACK TO YOUR IMPACT CRITERIA, AND ASK THE QUESTION, WHETHER OR NOT ALL APPLICANTS WHO RECEIVED AWARD ARE OBLIGATED TO SUBMIT FOR PUBLICATION, NUMBER ONE, AND WHAT WOULD THAT PERCENTAGE BE. AND NUMBER TWO, WHAT PERCENTAGE OF THOSE APPLICANTS, THAT WHATEVER THEIR IDEA WAS, WAS NOT SUCCESSFUL, WAS THAT PUBLISHED, BECAUSE THERE'S MORE -- THERE'S USUALLY JUST AS MUCH INFORMATION, GOOD INFORMATION, OUT OF NON-SUCCESSFUL INNOVATIVE IDEAS, AS THERE IS IN SUCCESSFUL IDEAS. >> IT'S A REALLY GREAT QUESTION. THE ABILITY TO PUBLISH NEGATIVE RESULTS IS THAT ONGOING QUESTION AT THE NIH, WITHIN THE SCIENTIFIC COMMUNITY, I THINK THERE'S RECOGNITION THAT THAT WOULD BE VALUABLE, THERE ARE LIMITED OPPORTUNITIES, LIMITED JOURNALS THAT THROUGH WHICH YOU CAN PUBLISH NEGATIVE RESULTS. SO, WE DON'T REQUIRE THAT. WE ALSO DON'T TECHNICALLY REQUIRE PUBLICATION OF POSITIVE RESULTS. IT'S GENERALLY TO THE RESEARCHER'S BEST INTEREST TO PUBLISH RESEARCH BECAUSE THAT'S HOW CAREERS ARE ADVANCED. WE CERTAINLY TRACK IT BUT THERE'S NO TECHNICAL REQUIREMENT. FOR CLINICAL RESEARCH, THAT IS THAT REQUIREMENT NOW. >> WE'RE GOING TO SKIP THE BREAK AND GO TO LARRY AT 10:30. IF YOU NEED TO TAKE A BREAK, PLEASE DO. >> I'M SORRY, I DIDN'T REALIZE I WAS EATING INTO A BREAK. CHRIS? >> ONE POINT RELATED TO THE LAST COMMENT, AN ISSUE WITH THE PUBLICATION OF NEGATIVE RESULTS, IF YOU USE CITATION INDEX THAT'S GOING TO MARKEDLY DECREASE ABILITY OF YOUR CITATION TO HAVE MEANING BECAUSE IT'S NOT GOING TO GET CITED OUTSIDE OF SHOWING IT DIDN'T WORK. I WANT TO GO BACK TO A POINT DR. FEINBERG RAISED. I THINK THAT THE ISSUE OF LIMITING SUBMISSIONS FROM AN INSTITUTION IS IMPORTANT ONE, AND I'M GOING TO SUGGEST THAT WHAT WE TAKE BACK IS MAYBE THEY LOOK AT A PHASED APPROACH, WHILE IT MAY BE TRUE YOU DON'T WANT LIMITED ABILITY OF UNDERREPRESENTED MINORITIES AS WELL AS WOMEN INVESTIGATORS FROM INSTITUTIONS THAT HAVE HIGH FUNDING AND A LOT OF THEM THERE, AT SOME POINT YOU HAVE TO THINK ARE YOU GETTING WHAT YOU WANT, AND THAT'S ALL YOU GET, SO MAYBE A PHASED APPROACH TO THAT RECOMMENDATION MIGHT BE MORE APPROPRIATE. >> OKAY, THANK YOU. KRISTIN? >> I WANTED TO GO BACK TO THAT AWARDING THE INSTITUTIONS THAT HAVE A LOT OF AWARDS ALREADY, WONDERED IF YOU HAD DONE THE SAME ANALYSIS FOR THE WOMEN, YOU KNOW, DO YOU GET THE SAME -- ARE THOSE DROPPING OUT IN FAVOR OF THE HIGHLY AWARDED INSTITUTIONS, AT THE AWARD STAGE AS OPPOSED TO APPLICATION, WHICH WOULD BE INFORMATIVE AND LARGELY BECAUSE EVEN WITHOUT BIAS IF YOU'RE TRYING TO REVIEW APPLICATIONS AND ASSESS WHAT'S GOING TO BE -- WHAT'S GOING TO GIVE HIGHEST REWARD YOU'RE INCLINED TO PROBABLY SUSPECT PLACES THAT HAVE A RICH RESOURCE WITH THEM ARE GOING TO SUPPORT THAT APPLICANT AND MAKE IT MORE LIKELY TO HAPPEN SO IT'S NOT UNREASONABLE. WHICH GETS ME TO THE RECOMMENDATION THAT SUGGESTS A SPECIAL PROGRAM THAT COMBINES INSTITUTIONS WITH DIFFERENT RESOURCES. THAT'S A VERY GOOD ONE IN THE OUTREACH ONE AND MIGHT SORT OF PULL IN OTHER INSTITUTIONS AND GET PEOPLE TO WORK TOGETHER. AND OVERCOME THAT A LITTLE BIT. AND THEN THE OTHER ONE I LIKE ACTUALLY IS NOTICING THE CLINICAL OUTCOMES IS I DO THINK THE SPECIAL TRACK AND TRYING TO GET MORE IN THE CLINICAL RESEARCH AND CLINICAL OUTCOMES THERE, IT'S NOT SURPRISING TO ME THESE TYPE OF AWARDS ARE BUILT TOWARDS TECHNOLOGY, AND TECHNOLOGY THAT SOLVES A PROBLEM THAT MIGHT HAVE A BIG IMPACT IS NOT SURPRISING, BUT I THINK IT WOULD BE REALLY GREAT, IT'S HARD TO CHANGE CLINICAL PRACTICES AND GET SOME GEARED TOWARDS DOING THAT AND IMPLEMENTATION AND OUTCOME, AND I THINK THERE, THERE'S A RECOMMENDATION HERE TOO IN FOCUSING ON THAT, AND THAT SPECIFICALLY WOULD BE A REALLY GOOD IDEA. >> GREAT. THANK YOU. IN ANSWER TO QUESTION ABOUT ANALYSIS, THE AWARDEE POOL IS SKEWED TOWARDS MOST RESEARCH INTENSIVE, APPLICANTS ARE MORE DIVERSE, AWARDS ARE MORE SKEWED, RIGHT. YES? >> SO I JUST WOULD LIKE TO GO BACK TO THE IDEA OF TRANSFORMATIVE RESEARCH, AND JUST ASK THE COMMITTEE TO CONSIDER IF THEY REALLY ARE IDENTIFYING THAT KIND OF RESEARCH, AS OPPOSED TO JUST ANOTHER MECHANISM WHICH IS STILL IMPORTANT BECAUSE THE R01 IS VERY INCREMENTAL, BUT IS THIS OUTSTANDING INCREMENTAL RESEARCH, ARE WE DOING TRANSFORMATIVE RESEARCH, ARE THE ERIC'S AND STANLEY'S OF THE WORLD GOING TO BE CAPTURED WITH THE MECHANISM OR NOT? BECAUSE THOSE CAN ABSOLUTELY CHANGE HOW SCIENCE IS DONE SO I JUST WANT TO HAVE SOME ATTENTION SPAN ON THE TRANSFORMATIVE ASPECT BECAUSE THAT RESEARCH COULD BE REALLY IMPORTANT AND VERY HARD TO FUND. >> RIGHT. SO, THE EVIDENCE THAT WE HAVE FROM THE PIONEERS AND NEW INNOVATORS, WE'RE FINDING THAT. WITH THE EVALUATIONS SHOW THAT RESEARCH IS HIGHER, HAS HIGHER IMPACT THAN R01s. WE'RE DOING EVALUATION NOW OF TRANSFORMATIVE RESEARCH AWARDS, SO WE'LL HAVE MORE EVIDENCE ABOUT THAT ABOUT A YEAR FROM NOW. OTHER QUESTIONS OR COMMENTS? YES? >> [INAUDIBLE, OFF MIC]. >> AT THIS POINT IT'S A STATEMENT. SO IN THE REQUEST FOR APPLICATIONS, WE MAKE IT CLEAR THAT ANY RESEARCH TOPIC WITHIN THE NIH PURVIEW IS ACCEPTED. AND I'M AGAIN LOOKING TO BECKY AND RAVI. I DON'T THINK THERE'S A SPECIFIC CALLOUT TO SAY WE'RE MISSING SO THAT THE STATEMENT OF THAT AS AN EMPHASIS AREA IS ONE OF THE THINGS THAT'S UP FOR DISCUSSION. SHOULD THAT BE AN EMPHASIS AREA, ONE OF THE RECOMMENDATIONS FROM THE WORKING GROUP IS THAT A SEPARATE CALL FOR CLINICAL APPLICATIONS BE CONSIDERED, WITH SEPARATE REVIEW PROCESS BECAUSE THEY ARE QUITE DIFFERENT IN TERMS OF THE RESEARCH. >> I WOULD RECOMMEND THERE'S SOME FOLLOW-UP, IDENTIFIED THIS AS A STATEMENT, SO I THINK THERE SHOULD BE SOME FOLLOW-UP IN TERMS OF DO WE WANT TO CHANGE THIS OR MAKING A STATEMENT TO MAKE A STATEMENT, DO WE REALLY WANT TO IMPROVE ON THE OUT OUTCOMES OF THE OVERALL PROGRAM, THEREFORE IF IT'S BEEN IDENTIFIED AS A FOLLOW-UP -- (INAUDIBLE) -- THERE SHOULD BE SOME FOLLOW-UP WHAT IT'S GOING TO DO ABOUT IT. >> OKAY. THANK YOU. OKAY. I THINK THIS HAS BEEN REALLY A WONDERFUL AND RICH DISCUSSION, SO THANK YOU VERY MUCH FOR YOUR INPUT AND YOUR THOUGHTS. AND WE WILL FEED THAT BACK TO THE ACD WORKING GROUP. >> OKAY. [APPLAUSE] AND WE WILL DO EXACTLY THAT. WE HAVE A COUPLE STAFF FROM THE WORKING GROUP WHO HAVE BEEN HERE LISTENING. WE'LL ALSO CONVEY EVERYONE'S IDEAS IN WRITING TO THE WORKING GROUP. WE'LL DO IT THROUGH LARRY, WHO IS A CO-CHAIR OF THE WORKING GROUP. THIS WAS AN INTERESTING CONVERSATION, AND IT GETS TO I THINK ONE OF THE CORE PURPOSES OF OUR DIVISION IS TO THINK ABOUT ARE WE GETTING -- DO WE HAVE THE RIGHT WAY TO GET TO WHAT WE WANTED FROM OUR INVESTMENT, SO WE HAVE THE OFFICE OF PORTFOLIO ANALYSIS THAT CAN DO QUITE A BIT WITH OUR DATA. WE HAVE NEWLY ESTABLISHED OFFICE OF EVALUATION PLANNING AND REPORTING, WHICH IS GOING TO BE IN THE SAME KIND OF SPACE, AND I'M GETTING A SENSE THAT WE SHOULD BRING SOME OF THESE TOPICS BACK TO THE COUNCIL IN THE FUTURE. SO NOW WE'LL GO ON TO DR. LARRY TABAK, OUR PRINCIPAL DEPUTY DIRECTOR, AND HE GIVES AN ANNUAL UPDATE ON -- WHAT'S ON LARRY'S MIND, I GUESS. >> YEAH. >> THANKS. >> THANK YOU. GOOD MORNING, EVERYBODY. SO, USUALLY WHEN I SHOW UP IT MEANS THAT FRANCIS ISN'T AROUND. HE WAS SUPPOSED TO BE OUT OF THE COUNTRY THIS WEEK, WHY YOU GET ME. TURNS OUT HE'S NOT OUT OF THE COUNTRY, BUT YOU STILL GET ME. SO I'M REALLY DELIGHTED TO BE HERE. AND THIS REALLY IS AN UPDATE AND OPPORTUNITY TO HEAR WHAT'S ON YOUR MIND, AS WELL. SO WHAT I THOUGHT WE COULD SPEAK ABOUT THIS MORNING IS FIRST TO TALK A LITTLE BIT ABOUT THE BUDGET AND FROM THE NIH PERSPECTIVE THERE'S EXTRAORDINARILY GOOD NEWS. BECAUSE WE'RE ALL HERE WORKING, RIGHT? WELL, ALMOST ALL OF US. THERE'S A SLIGHT PART OF NIH THAT UNFORTUNATELY IS COMPROMISED DUE TO PARTIAL ABSENT FUNDING AT THE NIEHS, BUT APART FROM THAT NIH'S FUNDING IS ON TIME, FOR THE FIRST TIME IN MANY, MANY YEARS. AND SO WE'RE ALL ABLE TO BE HERE. I'D LIKE TO SPEAK ABOUT THE INCLUDE PROJECT, THAT ACRONYM STANDS FOR INVESTIGATION OF CO-OCCURRING CONDITIONS ACROSS THE LIFESPAN TO UNDERSTAND DOWN SYNDROME. WE'LL TELL YOU ABOUT AN EXCITING NEW WORKING GROUP, ARTIFICIAL INTELLIGENCE, AND DESCRIBE NEW PROGRAMS RELATED TO NIH'S CONTRIBUTION TO THE OPIOID CRISIS, TERMED "HEAL." AND SO THAT WILL BE THE LIST OF THINGS. SO WITH REGARD TO THE BUDGET UPDATE, THIS IS A FIGURE THAT YOU'VE SEEN MANY TIMES BEFORE, AND OF COURSE THE GOOD NEWS IS OVER THE LAST SEVERAL YEARS WE'VE ENJOYED EXTRAORDINARY INCREASES, PARTICULARLY IN VIEW OF THE OVERALL BUDGETARY CLIMATE. AND WE'RE VERY GRATEFUL FOR THAT. AND I THINK AS A RESULT, YOU KNOW, WE'RE PLACED APPROPRIATELY SO UNDER INCREASEED SCRUTINY HOW WE'RE USING THESE RESOURCES. AND I THINK THAT'S FAIR. AND SO WE HAVE TO TAKE GREAT CARE AND BE ABLE TO DESCRIBE WHAT WE'RE DOING, WHY WE'RE DOING IT, HOW WE'RE PRIORITIZING AND SO FORTH. NOW, IF YOU JUST LOOK AT THE NUMBERS A LITTLE BIT MORE CAREFULLY, YOU'LL SEE THE CHANGE FROM 2018 TO THE CURRENT FISCAL YEAR WAS AN EXTRAORDINARY $2 BILLION INCREASE, I DON'T USE THAT TERM LIGHTLY. I MEAN, IT REAL IS AN EXTRAORDINARY INCREASE. GENERAL INCREASE FOR INSTITUTES AND CENTERS WAS GREATER THAN 3%. AND THEN TOGETHER WITH $7 BILLION OF INCREASES FROM 2016 THROUGH 2018, OVER HALF OF LOSS OF PURCHASING POWER SINCE 2003 HAS BEEN RESTORED. SO WE'RE NOT QUITE BACK TO WHERE WE WERE BUT WE'RE VERY MUCH ON THE WAY MAKING THE WHOLE ECOSYSTEM MORE HEALTHY. NOT RESTORED TO FULL HEALTH BUT IT'S MORE HEALTHY. AND, AGAIN, WE STARTED OUT WITH A GREAT DEAL OF GRATITUDE FOR THE CONFIDENCE THAT HAS BEEN SHOWN TO US IN PROVIDING US WITH THESE ADDITIONAL RESOURCE. NOW, I'D LIKE TO TALK ABOUT A PROJECT CALLED "INCLUDE." MOPPING NOTHING THAT I CAN SAY IS MORE IMPORTANT OR BETTER THAN WHAT YOU'LL HEAR FROM A PATIENT WHO IS ALSO AN ADVOCATE. SO I'M GOING TO PLAY A SHORT MOVIE OF HIS TESTIMONY, AND FRANKLY AFTER YOU HEAR HIM, YOU DON'T NEED TO HEAR ANYTHING MORE FROM ME. RIGHT? ALTHOUGH I'LL ELABORATE A LITTLE BIT. OKAY. SO THIS IS MR. STEPHANES. HOW DO WE TURN UP THE SOUND, FOLKS? I DON'T KNOW HOW TO TURN UP THE SOUND. IT'S A P.C. I DON'T KNOW HOW TO USE A P.C. OKAY. I'M GOING TO -- WE'LL TRY AGAIN ONCE WE FIGURE OUT HOW TO TURN -- DO YOU KNOW HOW TO USE A P.C.? AH, OKAY. YOU KNOW HOW TO TURN UP THE SOUND. OKAY, THANK YOU. SORRY. I HADN'T ANTICIPATED THIS BECAUSE IT WORKED SO WELL ON MY LAPTOP. THERE'S ALL KINDS OF WIRES BEING PUT IN NOW SO I THINK THIS MIGHT BE OKAY. ALL RIGHT. READY TO GO? LET'S TRY IT. NO. >> I THINK ON A PERSONAL NOTE, I CANNOT TELL YOU HOW MUCH IT MEANS TO ME. IT MIGHT LEAD TO THE ANSWER TO ALZHEIMER'S . IT'S LIKELY THAT WROTE ONE DAY, MY MEMORY, MY VERY LIFE, ME. THIS IS VERY HARD FOR ME TO SAY, BUT THIS HAS ALREADY BEGUN, MY MOM, ME. THINK ABOUT ALL THOSE PEOPLE YOU LOVE. THE WAY I LOVE MY MOM. HELP US MAKE THIS DIFFERENCE. IT'S NOT FOR ME AND MY MOM. IT'S FOR YOU AND THE ONES YOU LOVE. FUND THIS RESEARCH. SO, I HOPE YOU WERE ABLE TO HEAR. THE SOUND WASN'T OPTIMAL. THANK YOU FOR YOUR HELP. MR.STEPHENS, HE'S NOT REQUESTING FUNDING FOR HIM. HE'S REQUESTING FUNDING FOR ALL OF THOSE PEOPLE WHO ARE BOTH AFFECTED BY DOWN SYNDROME, BUT WHAT MAY NOT HAVE BEEN OBVIOUS BECAUSE OF THE SOUND QUALITY IS HE WAS ALSO REFERRING TO THE FACT THAT YOU CAN LEARN A GREAT DEAL BY STUDYING INDIVIDUALS WITH DOWN SYNDROME THAT IS VERY APPLICABLE TO THOSE THAT DO NOT HAVE DOWN SYNDROME. AND SO I'M SURE MANY OF YOU KNOW INDIVIDUALS WITH DOWN SYNDROME DO HAVE PREDELICTIONS FOR CERTAIN DISEASES AND CONDITIONS BUT THEY ALSO HAVE RESILIENCE TO OTHERS. AND SO BY STUDYING INDIVIDUALS WITH DOWN SYNDROME, IN PARTNERSHIP WITH THEM, NOT ONLY WILL INDIVIDUALS WITH DOWN SYNDROME BENEFIT BUT WE WILL ALL, THE GENERAL POPULATION, WILL BENEFIT. THAT WAS REALLY HIS MESSAGE. I HOPE YOU WERE ABLE TO HEAR THAT. SO, EACH YEAR ABOUT 6,000 INFANTS ARE BORN WITH DOWN SYNDROME. THEIR LIFESPAN HAS DOUBLED OVER THE LAST 25 YEARS. AND SO IT IS NOT UNCOMMON FOR PEOPLE TO LIVE INTO THEIR FIFTH AND EVEN SIXTH DECADE NOW. AND THIS WAS PART OF THE LANGUAGE IN OUR 2018 APPROPRIATION TO DEVELOP A NEW TRANS-NIH INITIATIVE TO STUDY TRISO MANIC 21 WITH THE AIM OF YIELDING SCIENTIFIC DISCOVERIES TO IMPROVE HEALTH AND NEURODEVELOPMENT OF INDIVIDUALS WITH DOWN SYNDROME AND AT RISK FOR THIS RANGE OF DISEASES AND CONDITIONS. THOSE ARE DOWN SYNDROME ARE AT GREATER RISK FOR THESE THINGS THEY ARE PARADOXICALLY RESISTANT TO MANY TIMES OF CANCERS AND DISEASE AND HEART ATTACK. THERE'S THIS UNIQUE DOUBLE BENEFIT, IF YOU WILL. THOSE ARE DOWN SYNDROME, THOSE WHO ADVOCATE FOR THEM ARE QUICK TO POINT OUT INDEED UNDERSTANDING RISK AND RESILIENCY THERE'S A SHARED COMMON GOOD HERE. SO, THE FUNDING FOR DOWN SYNDROME IS DISPLAYED ON THIS GRAPH IN MILLIONS OF DOLLARS, PUT ON TOP OF THE BASE OF SUPPORT. AS YOU SEE NOW, WE'RE UP TO ABOUT $59 MILLION AS A RESULT. WE DID A DUAL SOLICITATION. WE HAD TWO MAJOR THINGS IN MIND, WHEN WE INITIATED THIS. THE FIRST WAS TO EXPAND PROJECTS THAT WERE CURRENTLY SUPPORT IN DOWN SYNDROME, BUT THEN THE SECOND WAS TO AMEND OR AUGMENT EXISTING PROJECTS TO ADD A DOWN SYNDROME COMPONENT. ONE OF THE THINGS THAT MEMBERS OF THE COMMUNITY OF INDIVIDUALS WITH DOWN SYNDROME HAVE REALLY ASKED FOR IS THE OPPORTUNITY TO PARTICIPATE IN CLINICAL TRIALS, BROADLY SPEAKING, BECAUSE WE HAVE PRECIOUS LITTLE INFORMATION ABOUT HOW A NUMBER, IN FACT MOST INTERVENTIONS WILL PLAY OUT IN THE GENETIC BACKGROUND OF TRISOMY 21. THEY WANT TO VOLUNTEER FOR MANY TYPES OF TRIALS FOR THAT PURPOSE, AS WELL AS FRESH PERSPECTIVE INTO THE DOWN SYNDROME RESEARCH COMMUNITY. SO, THERE'S A WEBSITE THAT YOU CAN INTERROGATE AT THIS URL, WHICH LAYS OUT WHAT WE ARE CURRENTLY DOING, AND WHAT WE'RE DOING GOING FORWARD. SO THE PLAN AGAIN, THREE COMPONENTS, TO ADDRESS QUALITY OF LIFE ISSUES FOR INDIVIDUALS WITH DOWN SYNDROME, AND THEIR FAMILIES. IT BEGINS AS VIRTUALLY EVERYTHING AT NIH DOES WITH FUNDAMENTAL BASIC RESEARCH, TARGETED HIGH RISK, HIGH REWARD BASIC SCIENCE STUDIES ON CHROMOSOME 21, YOU HEARD ABOUT HRHR IN THE PRECEDING DISCUSSION. TO BUILD A LARGE COHORT OF INDIVIDUALS WITH DOWN SYNDROME FOR COMPREHENSIVE ANALYSES AND BIOMARKER, AND INCLUDE INDIVIDUALS WITH DOWN SIRCHED IN EXISTING AND -- WITH DOWN SYNDROME IN EXISTING FUTURE CLINICAL TRIALS. WE GOT OFF TO A LATE START BECAUSE OF TIMING OF APPROPRIATIONS, ABLE TO AWARD OVER $22 MILLION, 49 AWARDS, THIS WAS A TEAM SPORT. 14 INSTITUTES ENGAGED IN THIS. AND WE WERE ABLE TO ADDRESS ALL THREE OF THE COMPONENTS, AND THERE IS AN UNAMBIGUOUS DATA SHARING EXPECTATION ACROSS ALL THESE DIFFERENT THINGS. OBVIOUSLY I'M NOT TRYING TO GIVE AN EYE TEST HERE, BUT THIS LIST OF FUNDED PROJECTS, AGAIN YOU CAN INTERROGATE THIS URL FOR THE DETAILS. JUST TO GIVE YOU A FLAVOR OF THIS, IN THE BASIC RESEARCH STUDIES, EXAMINING THE ROLES OF MULTIPLE GENES ON CHROMOSOME 21 SIMULTANEOUSLY, CHROMOSOME SILENCING, SO IMPORTANT IN THIS SPACE, EVALUATE EPIGENETIC TRANSCRIPTOMIC PROFILING IN MODEL ORGANISMS, ORGANOIDS AND OTHER SYSTEMS, AND THEN WHILE SYSTEMS THAT ARE NON-NEURAL INCLUDING MOLECULAR ATLAS FOR CARDIOVASCULAR AND OTHER SPECIMENS AGAIN BECAUSE OF THE ARRAY OF PRESENTATION THAT THESE PATIENTS EXPERIENCE. IN ALL OF THE DELIBERATIONS ABOUT WHAT TO SUPPORT, THERE WAS AN EMPHASIS ON THOSE STUDIES THAT CAN INFORM THE OTHER TWO COMPONENTS OF THE EFFORT TO FORM THE MOST COHESIVE APPROACH WITH THE ULTIMATE GOAL OF THE POTENTIAL FOR CLINICAL TRANSLATION. COMPONENT 2, A COUPLE EXAMPLES, ASSEMBLE BIOMARKER STUDIES FIRST STUDIES, YOU'RE FAMILIAR WITH THAT WORK, BECAUSE INDEED THAT IS COMMON FUND IN COLLABORATION WITH NHLBI, NCI AND NICHD, GENETIC ANALYSES OF CHD AND ALL IN CHILDREN WITH DOWN SYNDROME AND GERMLINE AND SOMATIC VARIANTS IN MYELOID MALIGNANCIES IN CHILDREN. BECAUSE OF THE PREDELICTION FOR ALZHEIMER'S OR ALZHEIMER'S-LIKE CONDITION IN INDIVIDUALS WITH DOWN SYNDROME, THE ALZHEIMER'S BIOMARKERS CONSORTIUM, DOWN SYNDROME MULTI-SIDE PROJECT ARE OF COURSE AN IMPORTANT TARGET, EUNICE KENNEDY SHRIVER INTELLECTUAL AND DEVELOPMENTAL DISABILITIES RESEARCH CENTER AT VANDERBILT HAS A COHORT THAT WILL NOW EXPAND TO DOWN SYNDROME. SO WE CAN DO CROSS-COMPARISONS. AND THEN, AGAIN, IT'S NOT ALL NEUROLOGICA. CLINICAL EVALUATION OF PULMONARY HYPERTENSION WILL NOW EXPAND TO DOWN SYNDROME SO EMPHASIS ON BUILDING COHORT ACROSS THE ENTIRE LIFESPAN TO ADDRESS KEY HEALTH AND QUALITY OF LIFE ISSUES. COMPONENT 3, TO BUILD A CLINICAL TRIALS NETWORK FOR INCLUSION AND EXISTING AND FUTURE TRIALS, AS I ALREADY ALLUDED TO WAS EXTREMELY LIMITED MEDICATION TRIALS IN DOWN SYNDROME, WE HAVE TO TEST HOW COMMONLY USED MEDS AFFECT PEOPLE WITH DOWN SYNDROME, AND OF COURSE THAT WILL LEAD TO DEVELOPING APPROPRIATE CLINICAL MEASURES FOR INDIVIDUALS WITH DOWN SYNDROME. SO AGAIN ALWAYS THE EMPHASIS ON BUILDING CLINICAL RESEARCH RESOURCES TO ACHIEVE FULL INCLUSION BOTH NOW AND IN THE FUTURE. THERE HAVE BEEN A COUPLE OF WORKSHOPS THAT HAVE HELPED INFORM SOME OF THESE EFFORT. ALZHEIMER'S DISEASE WORKSHOP WAS COORDINATED BETWEEN THE CHILD HEALTH INSTITUTE AND AGING INSTITUTE. AND INDIVIDUALS FROM BOTH DOWN SYNDROME AND ALZHEIMER'S DISEASE ADVOCACY COMMUNITIES PARTICIPATED, AND ADDITIONALLY INVESTIGATORS WHO STUDY THESE TWO TIMES OF DISEASES ENGAGED IN CROSS-THOUGHT AS THEY WERE EY WERE WERE ABLE TO COMPARE THEIR EXPERTISE AND EXPERIENCE. THIS IS A TEAM SPORT, IN ADDITION TO 14 14 INSTITUTES AND CENTERS THERE'S A DOWN SYNDROME CONSORTIUM THAT NIH ENGAGES WITH, SO THESE INSTITUTES TOGETHER WITH THESE MANY GROUPS, WE CONVENE THEM IN JULY AND NOVEMBER TO TALK TO THEM AND GET THEIR INPUT ABOUT THESE EFFORTS. SO 2019 AND BEYOND, FUNDING OPPORTUNITY ANNOUNCEMENTS RELEASED JULY 3, WORKSHOPS IN 2019 TO PLAN VIRTUAL COHORT, SO PLEASE DO INTERROGATE THIS SITE IF YOU OR YOUR COLLEAGUES HAVE AN INTEREST IN THESE AREAS. THIS IS VERY BROAD. YOU WOULD HAVE TO WORK AT NOT FINDING A CONNECTION TO SOMETHING THAT EITHER YOU OR YOUR COLLEAGUES ARE INTERESTED IN. SO PLEASE DO CONSIDER THIS. THIS IS THE FOLKS THAT DID ALL THE WORK. ANN CAME UP HERE TO RESCUE ME HAS DONE AN EXTRAORDINARY JOB IN HERDING ALL THESE CATS, AND DIANA BIANCHI, DIRECTOR OF CHILD HEALTH, AND GARY GIBBONS DIRECTOR OF NHLBI HAVE PERSONALLY BEEN ENGAGED IN THIS AND MANY EXTRAORDINARILY TALENTED STAFF FROM ACROSS NIH. YOU CAN SEE FROM MANY INSTITUTES AND CENTERS. REALLY AN OUTSTANDING OPPORTUNITY AND I THINK WE'RE COMING UP WITH SOME VERY VALUABLE THINGS AS A RESULT. OKAY. NOW I WANT TO TURN TO THE NEXT TOPIC, AN UPDATE ON A NEWLY FORMED ACD WORKING GROUP, WORKING GROUP. WE HAVE A LOT OF WORKING GROUPS THIS ONE ON ARTIFICIAL INTELLIGENCE. SO, JUST TO FRAME THIS WITH SOME PERSPECTIVE, AND SOME MEMBERS OF MY STAFF KID ME BECAUSE THEY THINK I'M REFERRING TO WHAT I SAW BACK IN 1870, WHICH IS NOT EXACTLY TRUE. [LAUGHTER] BUT IF YOU THINK ABOUT THE INDUSTRIAL REVOLUTION, AND HERE I CAN SPEAK TO, YOU KNOW, 1970 WASN'T THAT LONG AGO WHEN THESE THINGS STARTED POPPING UP ON PEOPLE'S DESKS. I TRY AND EXPLAIN TO MY POSTBACs THAT THE FIRST COMPUTER I WORKED WITH WAS A WANG CALCULATOR, AND IT WAS ABOUT AS BIG AS THE INTERNAL PERIMETER OF THIS TABLE. AND TODAY YOUR WATCHES HAVE ABOUT TWO ORDERS OF MAGNITUDE MORE COMPUTATIONAL POWER THAN THAT WANG CALCULATOR HAD AND FOR QUANTITATIVE CHEMISTRY WERE NOT ALLOWED TO USE IT BECAUSE IT WASN'T ACCURATE ENOUGH. YOU HAD TO USE A 13-PLACE LOG TABLE. WE HAVE COME A LONG, LONG WAY, BUT NOW IF YOU FAST FORWARD FROM 1970, 40+ YEARS LATER, AND WE'VE GOT OBVIOUSLY AN EXPLOSION OF DATA, THAT IS AN UNDERSTATEMENT BEYOND ALL UNDERSTATEMENTS, THE OPPORTUNITY WITH NEW TOOLS TO BEGIN TO NOT ONLY STORE MASSIVE DATA SETS BUT TO BEGIN TO COMPUTE ACROSS THEM, EVEN THOUGH THEY MAY BE DISPARATE IN NATURE, AND THAT'S EXCITING BECAUSE NOW WHEN WE STITCH TOGETHER COHORTS, IT'S A CHALLENGE, BUT THIS MAY ACTUALLY HELP US DO THAT IN A MUCH MORE REALISTIC WAY, AND THEN OF COURSE THERE'S THIS ARTIFICIAL INTELLIGENCE, AND ROBOTICS AND SO IT'S A WHOLE NEW UNIVERSE, TO BE SURE. JUST TO GIVE YOU SOME PERSPECTIVE ABOUT TEN YEARS AGO I SPOKE BEFORE A GROUP OF PROVOSTS OF THE UNIVERSITY OF CALIFORNIA SYSTEM, AND I WAS TRYING TO IMPRESS THEM ABOUT TEN YEARS AGO HOW MUCH DATA NIH GENERATES. AND THEY STARTED LAUGHING AT ME. NOW, IT'S NOT THAT I'M NOT USED TO PEOPLE LAUGHING AT ME BECAUSE THAT HAPPENS ALL THE TIME. BUT I WAS A LITTLE TAKEN ABACK BY THIS LAUGHTER. I SAID, WHAT'S SO FUNNY? WHICH IS PROBABLY NOT THE RIGHT THING TO SAY SPEAKING TO A GROUP, BUT I DID NEVERTHELESS. TURNS OUT THEY WERE ASTROPHYSICISTS, HIGH ENERGY PHYSICISTS, AND COSMOOLOGIST, THEY WERE LAUGHING BECAUSE OF THEIR PROFESSIONAL BACKGROUNDS. WE'VE ARRIVED. WE'RE WHERE THEY WERE AND BEYOND IN MANY CASE. EACH DAY -- OOPS. EACH DAY, WE MOVE FOUR PETABYTES OF DATA ACROSS OUR CAMPUS. WE'VE GOT ABOUT 15 PETABYTES OF GENOMIC SEQUENCE DATA, AND THAT IS LIKE DOUBLING, AS WE SIT HERE IT'S DOUBLING. SOMETHING LIKE GTEx, 200 TERABYTES, THAT SEEMS TINY, RIGHT? IT'S SUBSTANTIAL. AND THIS JUST LISTS MANY OF OUR HIGH -- VERY DATA RICH ASSETS, AND SOME OF THESE -- AGAIN, I APOLOGIZE FOR THE TYPEFACE, BUT THERE ARE SOME HERE LIKE FOR EXAMPLE GABRIELLA KIDS FIRST PEDIATRIC RESEARCH PROGRAM AND GTEx THAT YOU WOULD BE FAMILIAR WITH BECAUSE THEY ARE COMMON FUND PROGRAM. AND EACH OF YOU, WHETHER YOU'RE LIKE ME, DEPENDS ON A MacINTOSH TO BE SMARTER THAN I AM SO I DON'T HAVE TO FIGURE OUT HOW TO MAKE THE SOUND GO HIGHER OR FAST FORWARD WITH COMPUTATIONAL SCIENCE, EVERY ONE OF YOU DEALS WITH ARTIFICIAL INTELLIGENCE WHETHER YOU KNOW IT OR NOT. HERE ARE THE MANY EXAMPLES. SOMEBODY TOLD ME RECENTLY THAT THEY HAVE TWO OF THESE THINGS, THESE TWO THINGS TALK TO ONE ANOTHER. THAT IS A VERY SCARY THOUGHT TO ME, BUT OKAY, IF IT WORKS, IT WORKS. OCCASIONALLY I HIT THE WRONG BUTTON, AND THIS THING STARTS ASKING ME WHAT THEY CAN HELP ME WITH, I DON'T KNOW HOW TO TURN IT OFF. [LAUGHTER] I MEAN, IT BECOMES A COMEDY ROUTINE. BUT I WILL TELL YOU AS SOMEBODY WHO THINKS THAT NORTH IS THIS WAY AND SOUTH IS THIS WAY, THIS IS THE MOST AMAZING INVENTION I'VE EVER SEEN IN MY ENTIRE LIFETIME. I'M NOT LOST ANYMORE! I LOVE THIS. THIS IS SO WONDERFUL. OF COURSE, IT'S ALL BASED ON THESE TYPES TIMES OF TECHNOLOGIES. SO, SOME OF YOU ARE FAMILIAR WITH THIS, OTHERS PERHAPS THIS IS NEWS. BUT THE CLINICAL APPLICATIONS FOR ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING AND DEEP LEARNING ARE EXPLODING, AND PARTICULARLY IN DIAGNOSTICS, PATHOLOGY DIAGNOSTICS, DERM, OPHTHALMOLOGY, RADIOLOGISTS, I'VE HAD MORE THAN ONE RADIOLOGIST OPINE THAT THEY ARE NOT QUITE SURE WHAT THEIR HALF-LIFE IS BECAUSE OF THE EXTRAORDINARY SUCCESS OF THESE APPROACHES. BUT IT GOES BEYOND JUST DIAGNOSTICS, INFERRING TREATMENT OPTIONS FOR CANCER, ROBOTIC SURGERIES, AND THEN OF COURSE NATURAL LANGUAGE PROCESSING OF ELECTRONIC HEALTH RECORDS BECAUSE MAYBE NATURAL LANGUAGE PROCESSING WILL BE ABLE TO SORT OUT THE MORASS THAT WE HAVE CREATED. SO-- BUT THEN ON THE BASIC SCIENCE SIDE, IMAGING SCIENCE IS NOW SO EXTRAORDINARY AS A RESULT OF THESE TECHNOLOGIES. NOT THE LEAST OF WHICH IS, YOU KNOW, ELECTRON MICROSCOPY, WHICH YOU KNOW ABOUT BECAUSE YOU'VE BEEN HELPING TO SUPPORT THIS, WHERE YOU DON'T HAVE TO CRYSTALLIZE THINGS ANYMORE BUT CAN USE ELECTRON MICROSCOPY IN A SOPHISTICATED WAY BUT IT'S REVOLUTIONIZING STRUCTURAL BIOLOGY. NEUROSCIENCE HAS EXPLODED AS A RESULT. AND OF COURSE GENOMICS IS SORT OF THE THING THAT BEGAN A LOT OF EFFORTS IN THIS, WITH MICROBIOME AND METAGENOMICS AS SORT OF A TRAILER. BUT NOW FULLY ENGAGED IN THIS, AND EPIGENOMICS AS WELL. WE HAD A WORKSHOP, IN THIS ROOM OR ONE OF THESE ROOMS, LAST JULY HARNESSING ARTIFICIAL INTELLIGENCE, MACHINE LEARNING, TO ADVANCE BIOMEDICAL RESEARCH. AND, YOU KNOW, THERE WERE TWO TYPES OF PEOPLE IN THE ROOM, PEOPLE LIKE ME, I COULD SPELL A.I. IF YOU SPOTTED ME THE A, BUT THAT WAS ABOUT IT AND PEOPLE WERE SOPHISTICATED PRACTITIONERS BUT EVERYBODY LEARNED SOCK FROM THE MEETING, THAT'S WHY WE THINK THINK IT WAS -- IT'S ONLINE IF ANYBODY WANTS TO INTERROGATE THIS, YOU CAN. WE'VE FORMED THIS WORKING GROUP AND WITH ONE EXCEPTION EVERYBODY ON THIS WORKING GROUP IS A TRUE EXPERT. THIS GUY, NOT SO MUCH. BUT EVERYBODY ELSE ON THIS GROUP ARE TRUE EXPERTS. WHAT IS REALLY AMAZING ABOUT THIS IS FOR SOME OTHER WORKING GROUPS WE'VE DONE WE HAVE SORT OF PURPOSESLY REACHES OUT FOR PEOPLE IN ALL CAREER STAGES BECAUSE WE'VE DECIDED IT'S HEALTHY WHEN TALKING ABOUT THE NEXT GENERATION OF RESEARCHERS OR HIGH RISK, HIGH REWARD RESEARCH, TO GET PERSPECTIVES OF PEOPLE EARLY IN THEIR CAREER, IN THIS CASE IF YOU WANT THE TRUE EXPERTS YOU HAVE TO GET GRADUATE STUDENTS AND POSTDOCS. I KID YOU NOT. A NUMBER OF PEOPLE ARE EARLY IN, QUOTE, TRADITIONAL CAREER, BUT NOT EARLY IN THEIR ACUMEN, ACCOMPLISHMENT OR EXPERIENCE IN THIS SPACE. SO, THERE'S SOME PEOPLE HERE WHO ARE JUST QUITE AMAZING WHAT NEFF ACCOMPLISHED. WE'RE REALLY LOOKING FORWARD TO THIS. WE'RE SETTING THIS OFF WITH THE FIRST MEETING I THINK ON THE 8th, 8th OF FEBRUARY, AND SO STAY TUNED. AND ETHICS EXPERT HAS BEEN ADDED AS WELL, BUT I DIDN'T HAVE TIME TO FIX THE SLIDE. OKAY. THE CHARGE, ARE THERE OPPORTUNITIES FOR CROSS-NIH EFFORT IN ARTIFICIAL INTELLIGENCE, HOW COULD THESE EFFORTS REACH BROADLY ACROSS BIOMEDICAL TOPICS AND HAVE POSITIVE EFFECTS, MANY IN DIVERSE FIELDS, VERY, VERY, VERY IMPORTANT. HOW DO WE BUILD THAT BRIDGE BETWEEN THE COMPUTER SCIENCE SAVVY COMMUNITY AND PEOPLE LIKE ME, FROM THE BIOMEDICAL COMMUNITY. WHAT CAN WE DO TO FACILITATE TRAINING THAT MARRIES BIOMEDICAL RESEARCH WITH COMPUTER SCIENCE, THE EXPERTISE IS NECESSARY BUT CAREERS MAY NOT LOOK LIKE OUR TRADITIONAL BIOMEDICAL RESEARCH CAREERS LOOK LIKE. AND THIS IS SOPPING THAT MEDICAL SCHOOLS IN PARTICULAR BUT OTHER INSTITUTIONS ARE GOING TO HAVE TO GET THEIR ARMS AROUND, THE TRADITIONAL TENURE TRACK POSITIONS THAT WE ALL GREW UP IN AND LOVE AND SO FORTH, OR LOATHE, DEPENDS HOW YOU FEEL BIT, THESE KIDS COME OUT OF COLLEGE WITH EXTRAORDINARY ABILITY, AND WE HAVE TO FIGURE OUT HOW TO DEAL WITH THAT. AND THEN VERY IMPORTANTLY TO IDENTIFY THE MAJOR ETHICAL CONSIDERATIONS AS THEY RELATE TO BIOMEDICAL RESEARCH USING ALL OF THESE APPROACH ALSO, ARTIFICIAL INTELLIGENCE, MACHINE LEARNING, AND DEEP LEARNING, FOR HEALTH-RELATED RESEARCH AND CARE, AND TO SUGGEST HOW WE MIGHT BE ABLE TO BUILD THESE CONSIDERATIONS INTO ALL OF ITS PROGRAMS, VERY, VERY IMPORTANT. OKAY. FINALLY, THE HEAL INITIATIVE. I DON'T THINK I HAVE TO CONVINCE YOU THAT WE HAVE A CRISIS IN THIS COUNTRY. THESE HEAT MAPS ARE SOBERING. AND SADLY TELL THE STORY. 1999, THERE WERE ISSUES, BUT IF YOU FAST FORWARD TO 2016, THE HEAT MAP SHOWS THE EXTRAORDINARY INCREASE IN DEATHS DUE TO OVERDOSE. 2017, 70,237 OVERDOSE, ALMOST 10% HIGHER THAN THE PRECEDING YEAR. AND SO THIS IS -- AND SADLY THIS IS IN FACT LOCALIZED, BUT NO PLACE IS IMMUNE. NO PLACE IS IMMUNE. NIH'S APPROACH TO THIS IS TO USE SCIENCE AS ONE MEANS OF HELPING TO SOLVE THESE DILEMMAS. THE HEAL INITIATIVE, HELPING TO END ADDICTION LONG-TERM, THE ACRONYM, AGAIN, THERE'S A WEBSITE WHICH I CERTAINLY ENCOURAGE YOU TO INTERROGATE. IT IS A TRULY TRANS-NIH INITIATIVE. LITERALLY EVERY INSTITUTE AND CENTER ENGAGED IN THIS. AND OF COURSE THE GOALS ARE TO IMPROVE PREVENTION AND TREATMENT STRATEGIES, BOTH FOR OPIOID MISUSE AND ADDICTION, BUT ALSO TO ENHANCE PAIN MANAGEMENT. SO IF YOU'RE A CLINICIAN, AND IF YOU THINK ABOUT WHAT YOU CAN PRESCRIBE TO PATIENT IN CHRONIC PAIN, YOUR ARMAMENTARIUM, YOU WANT TO PICK SOMETHING NON-ADDICTIVE IN NATURE, WHAT DO YOU REACH FOR? RIGHT? SO THIS IS THE OTHER PIECE OF THIS, AND A VERY IMPORTANT PIECE. WE'RE LOOKING AT BOTH SIDES OF THIS EQUATION. THE GOALS OF SCIENTIFIC SOLUTIONS, I CAN'T EMPHASIZE THIS ENOUGH WE'RE DOING THIS IN COORDINATION WITH THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, BECAUSE MANY OF OUR SISTER OpDivS AND STAFF DIVS HAVE QUIT -- EQUITY IN THIS SPACE. THE SURGEON GENERAL'S OFFICE, LOCAL OFFICIALS, THIS IS A LOCAL PROBLEM, AND WE CAN'T DO THIS FROM TOP DOWN, WE NEED AM GRASS ROOT LOCAL INTERVENTION. EFFORT IS $500 MILLION A YEAR, FORTUNATE TO RECEIVE THIS AS ADDITIONAL BUMP UP IN OUR APPROPRIATION. WE ANTICIPATE OBLIGATING OVER $850 MILLION THIS FISCAL YEAR. YOU MAY SAY WAIT A MINUTE, HOW DID YOU GET $850 FROM $500? FIRST YEAR, TIMING OF APPROPRIATION, CONGRESS RECOGNIZED WE MAY NOT BE ABLE TO APPROPRIATELY SPEND ALL THE $500 YEAR AND ALLOWED US TO CARRY OVER INTO THIS FISCAL YEAR, THAT $350 MILLION REPRESENTS THE CARRYOVER. 12 NIH I.C.s ARE LEADING 26 PROJECTS, BUT OVER 20 COLLABORATING INSTITUTES AND CENTERS, SO VIRTUALLY EVERY PART OF THE NIH IS ENGAGED IN THIS. THIS SPANS FROM PREVENTION RESEARCH ALL THE WAY TO IMPLEMENTATION SCIENCE, AND WE'RE DOING THINGS THAT INTEGRATE RESEARCH INTO NEW SPACES. SOY SO IT'S NOT JUST TRADITIONAL HEALTH CARE ENVIRONMENT BUT ENGAGES ARE CRIMINAL JUSTICE SYSTEMS, FOR EXAMPLE, IF WE TURN A BLIND EYE TO THAT WE'RE MISSING A WHOLE OPPORTUNITY FOR POTENTIAL INTERVENTION. WE'VE JUST ANNOUNCED 36 FUNDING OPPORTUNITY ANNOUNCEMENTS FOR 2019. AND THE PRIORITY AREAS ARE LISTED HERE TO EXPAND THERAPEUTIC OPTIONS, ENHANCE THERAPEUTIC STRATEGIES, ENHANCE TREATMENT FOR INFANTS WITH THE SYNDROME, CHILDREN BORN ADDICTED. AND HERE ARE SPECIFICS OF RESEARCH OPPORTUNITIES WHICH I'M NOT GOING TO GO THROUGH EACH BECAUSE OF TIME BUT YOU CAN SEE IT'S A FULL RANGE OF OPPORTUNITIES THAT ARE BEING EXPLORED HERE. THERE HAVE BEEN A NUMBER OF ADVANCES, LET ME HIGHLIGHT ONE. NASAL NARCAN, WE HAVE KNOWN ABOUT NALOXONE A LONG TIME, APPROACH TO OVERDOSE REVERSAL, BUT UNLESS YOU'RE A DOC, YOU'RE LOATHE TO INJECT SOMEBODY WITH ANYTHING. AND IT WAS GETTING IN THE WAY OF TIMELY ADMINISTRATION. WELL, ANYBODY IS WILLING TO SQUIRT SOMETHING UP SOMEBODY'S NOSE. THERE'S NO BARRIER THERE. EVERYBODY WILL DO IT. AND SO THIS APPROACH WHICH THE NIH AND NIDA IN PARTICULAR HAD A GREAT DEAL TO DO, YOU KNOW, TOOK A GIANT STEP FORWARD, AND THERE HAVE BEEN OTHER ADVANCES BUT, AGAIN, FOR TIME I'LL JUST MOVE. YOU KNOW, TO EXPAND THERAPEUTIC OPTIONS, YOU KNOW, AGAIN IF YOU'RE PHYSICIANS OR, YOU KNOW, OTHER TYPE OF CLINICIAN YOU KNOW WHAT SOME LIMITATIONS ARE. AND, YOU KNOW, HOW DO WE PREVENT RESPIRATORY DEPRESSION? WE NEED A WHOLE NEW CLASS OF COMPOUNDS. COULD WE USE IMMUNOTHERAPIES TO BLOCK CROSSING THE BLOOD BRAIN BARRIER? COULD DEVICES DO SOMETHING? ARE THERE NEW MEDICATION TARGETS? SO MANY OF THE TARGETS NOW ARE THE SAME OVER AND OVER AND OVER AGAIN. IN ORDER TO GET READY TO DO THESE SORTS OF TESTING THAT WILL BE REQUIRED, WE'RE ENHANCING AN EXTANT CLINICAL TRIALS NETWORK THAT NIDA HAS INVESTED IN, AS I MENTIONED EARLIER, YOU KNOW, FOCUSING ADDITIONALLY ON THE CRIMINAL JUSTICE SYSTEM AS A PLACE TO DO SOME NEW INNOVATION. BEHAVIORAL INTERVENTIONS, THESE COULD BE SO IMPORTANT IN MANAGING CHRONIC PAIN. FRANKLY, TRADITIONAL MEDICINE GIVES THEM SHORT SHRIFT. WHAT CAN WE DO TO ENHANCE BEHAVIORAL RESEARCH TO IMPROVE MEDICATION-ASSISTED TREATMENT? THIS IS DONE IN COLLABORATION WITH SAMHSA. AND THEN FINALLY THE HEALING COMMUNITY STUDY WHERE YOU ACTUALLY TEST INTEGRATED STRATEGIES IN A SMALL NUMBER OF COMMUNITIES THAT HAVE BEEN UNFORTUNATELY HIGHLY AFFECTED BY THIS CRISIS. I'M GOING TO RUN THROUGH THESE REALLY QUICKLY, GIVEN THE TIME. BUT I WANT TIME FOR -- YOU KNOW. AND SO AGAIN EVERYBODY HAS THE SLIDES SO YOU CAN SEE THE FULL RANGE OF THINGS. KIDS WITH NEONATAL OPIOID SYNDROME, HOW DO YOU TREAT THESE KIDS, WHAT'S THE CONSEQUENCE TO COGNITIVE DEVELOPMENT? AND THEN HEALTHY BRAIN AND CHILD DEVELOPMENT STUDY HOPEFULLY WILL PROVIDE SOME INSIGHTS TO THAT. IF YOU LOOK AT THE PROGRAMS FOR PAIN, THE ENTIRE SPECTRUM FROM BASIC DISCOVERY ALL THE WAY TO PRAGMATIC AND IMPLEMENTATION STUDIES IS ARRAYED HERE ON THIS SORT OF TIME LINE, IF YOU WILL AND, AGAIN, I HOPE YOU WILL SEE THAT WE HAVE ATTEMPTED TO COVER, ADDRESS MANY OF THE -- MANY COMPLICATED FEATURES OF THIS. AND I THINK THAT THIS IS A DEPICTION OF SO-CALLED SPARC, A COMMON FUND PROJECT. NON-OPIOID APPROACHES. YOU KNOW, WHAT WILL THIS TELL US? AND THEN JUST AS WE NEED A NETWORK SET UP, READY TO TEST NEW INTERVENTIONS RELATED TO OPIOID MISUSE, ANOTHER NETWORK IS REQUIRED TO TEST ANY NEW ASSETS THAT WE FIND, EITHER OBTAINED THROUGH PARTNERSHIP OR DISCOVERY, TO DO PAIN MANAGEMENT. AND SO THIS IS ALL BEING USED AS A VERY IMPORTANT ADJUNCT TO THIS. I DON'T KNOW HOW MANY PEOPLE HERE SUFFER FROM BACK PAIN. IT'S CERTAINLY AMONG THE MOST COMMON. SO THERE'S A SPECIFIC PROGRAM FOR THIS, AS WELL. AGAIN, NON-ADDICTIVE BIOLOGIC DEVICES AND COMPLEMENTARY APPROACHES. NOT JUST TO REDO WHAT WE ALWAYS DO. AND THEN WE'VE TALKED ABOUT A.I. DEVELOP PATIENT-CENTEED ALGORITHMS. PEOPLE ON HEMODIALYSIS -- ALL CHRONIC PAIN IS NOT THE SAME SO WE'RE FINDING VERY SPECIFIC EXAMPLES OF CHRONIC PAIN WHERE WE THINK UNIQUE INTERVENTION MAY BE IMPORTANT, PRAGMATIC STUDY TOGETHER WITH COLLABORATION WITH CMS, VIS-A-VIS MEDICARE COVERAGE CONSIDERATION. OKAY. SO SORRY FOR ROCKETING THROUGH THE LAST PIECE, I SPEND SO MUCH TIME ON A.I. BECAUSE THAT'S THE FUN PART. BUT HOPEFULLY WE'LL HAVE TIME FOR A FEW QUESTIONS. >> GO AHEAD. THANK YOU, LARRY. CHOOSE THE SPEAKERS. >> I'D LIKE TO GO BACK TO THE A.I. AND JUST SAY THAT WE DO AT OUR INSTITUTE, AND DESPITE THE FEELING THAT YOU HAVE, THAT YOU'RE AWESTRUCK AND IT'S OVERHYPED, WHEN YOU GET INVOLVED IT'S EVEN BETTER THAN YOU THINK. IT'S AS CLOSE TO MAGIC AS I'VE EVER SEEN. IT'S ABSOLUTELY ASTONISHING. HAVING SAID THAT THERE'S A BULLET POINT I'D LIKE TO HAVE YOU ADD. THAT IS, IN TRAINING. THE MATHEMATICS TRAINING THAT WE'VE TRADITIONALLY HAD IS VERY EARLY 20th CENTURY PHYSICS BASED. AND IT'S VERY CALCULUS BASED, OFTEN THREE SEMESTERS. THAT COULD BE COMPRESSED INTO ONE. YOU NEED COMPUTATION, YOU NEED ALGEBRA, YOU NEED STATISTICS, AT THE UNDERGRADUATE LEVEL AND Ph.D. LEVEL, BOTH TO BE NICE TO STRATEGIC THAT GROUP ACTUALLY THINK ABOUT HOW TRAINING MIGHT BE TRAINED TO DEAL WITH ALL DATA, WHETHER BIG DATA OR SMALL, AND A.I. IN PARTICULAR. >> YEAH, THANK YOU FOR RAISING THAT UP TO THE GROUP. THIS CAME UP IN SOME PRELIMINARY CONVERSATIONS, HOW WE HAVEN'T EVOLVED OUR MATHEMATICAL TRAINING. WE'RE STILL VERY TRADITIONAL. AND SO THANK YOU. BUT SO WE'LL HAVE TO CALL THAT OUT SPECIFICALLY. PLEASE. >> THANK YOU VERY MUCH FOR A VERY COMPREHENSIVE PRESENTATION. I HAVE TWO QUESTIONS. ONE IS REGARDING DOWN SYNDROME. AND I SAW THE LIST OF STUDY AND RESEARCH BUT DID NOT SEE ANYTHING ON THE SEARCH REGARDING THE CARETAKER. AND THAT'S SO IMPORTANT. >> YES. >> IN TERMS OF OUTCOME FOR DOWN SYNDROME. AND THE OTHER IS ON THE OPIOID, I WONDER IF YOU THOUGHT ABOUT ANY MORE WAYS, RESEARCH ON EDUCATIONAL PROGRAMS FOR RESIDENTS AND FELLOWS, BECAUSE THEY ARE AT THE FRONT LINES, ESPECIALLY AT ACADEMIC INSTITUTIONS. >> WITH REGARD TO THE FIRST QUESTION, I'M UNAWARE WE HAVE FUNDED ANYTHING RELATED TO CAREGIVERS, ALTHOUGH I DO KNOW THAT IN THE VARIOUS MEET ALSO THAT WE'RE HOLDING, INDIVIDUAL WHO ARE CAREGIVERS ARE WELL REPRESENTED, BUT I'M UNAWARE OF ANY SPECIFIC INITIATIVE. I'M LOOKING TO ANNA, WHO HAS SPENT SO MUCH TIME ON THIS. >> I MEAN, I CAN -- (INAUDIBLE). >> USE THE MICROPHONE. >> THANK YOU FOR THAT OBSERVATION. I CAN SAY THAT NIDCD, INSTITUTE ON COMMUNICATION AND DEAFNESS DISORDERS, HAS BEEN INVOLVED WITH THIS PROJECT. I KNOW IN THIS PAST FISCAL YEAR WE DID FUND WORK FROM THEIR INSTITUTE ON SPECIFIC COMMUNICATION STRATEGIES FOR INDIVIDUALS WITH DOWN SYNDROME, BUT THE OTHER THING I CAN SAY IS THAT WE'RE VERY EXCITED THERE'S GOING TO BE A LOT MORE SUPPORT THIS FISCAL YEAR FOR INCLUDE, PATIENT ORIENTED LARGER SCALE CLINICAL WORK WILL STILL BE FUNDED THIS YEAR SO WE SHOULD HAVE MORE TO SAY ABOUT THAT. >> OKAY. THANK YOU. AND THEN WITH REGARD TO THE TRAINING OF RESIDENTS, I'LL ADD, YOU KNOW, OTHER HEALTH PROFESSIONALS, I'M A DENTIST, OTHER HEALTH PROFESSIONALS, AND PEOPLE IN E.D.s, EMERGENCY DEPARTMENTS, AND SO IN A BROADER EFFORT OF COURSE THE CDC ISSUED ITS GUIDELINES, WHICH SORT OF ARE UNDERPINNING THIS TYPE OF WORK, THERE HAVE ALSO BEEN FUNDED SEVERAL CENTERS FOR TRAINING, SPECIFICALLY, BUT I'M GOING TO TURN TO REBECCA BAKER, WHO HAS BEEN COORDINATING THIS FOR DR. COLLINS, IF THERE'S ANYTHING SPECIFIC FOR RESIDENTS BECAUSE THAT'S ACTUALLY A VERY IMPORTANT POINT YOU RAISE. THEY ARE AT THE FRONT LINE INTERFACE. >> THAT'S RIGHT. I THINK WE'RE TRYING TO TAKE ON THAT COMPONENT OF THE CHALLENGE, THROUGH THE LONG TERM OR HEAL INITIATIVE THROUGH OUR COLLABORATION. WE WORK DO GENERATE DATA AND WANT TO WORK CAN STAKE HOLDERS, FEDERAL PARTNERS TO MAKE SURE INFORMATION IS RAPIDLY DISSEMINATED. >> I THINK YOU WANT TO MAKE ANOTHER -- >> I'D LIKE TO COMMENT. >> ONE SECOND. THERE'S A FOLLOW-UP COMMENT. >> YEAH. >> THERE IT IS. >> I'VE GOT ONE HERE. SO, YES, AAMC IS WORKING WITH HOW DO YOU INCORPORATE THIS INTO MEDICAL TRAINING FOR MEDICAL STUDENTS BUT ALSO ACG ANDE E IS LOOKING HOW TO INCORPORATE INTO RESIDENCY AND FELLOWSHIP TRAINING PROGRAMS, SO INSTEAD OF PEOPLE ALL IN THEIR SILOS I THINK IT WOULD BE IMPORTANT TO GENERATE THE RESEARCH AND THE RESEARCH DATA THAT WILL ALLOW US TO DETERMINE WHAT TECHNOLOGIES OR MECHANISMS ARE EFFECTIVE SO THAT WE CAN THEREFORE ADDRESS OUR INTERVENTIONS BASED ON DATA. >> IT'S A VERY, VERY IMPORTANT POINT. I THINK AGAIN WE'RE -- WHEN PEOPLE TALK ABOUT PARTNERS AND CONSORTIUM, WE'LL NEVER GET DONE, I THINK THIS IS SOMETHING THERE. PEOPLE ARE SO INTEGRATED HOW THEY ARE DOING THINGS, I THINK THIS HAS A VERY STRONG LIKELIHOOD OF SUCCESS, BUT THANK YOU FOR RAISING THIS SPECIFIC POINT AND WE NOW IN TURN WILL EMPHASIZE TO THE GROUPS OF FOLKS THAT WE ARE WORKING WITH. I THINK YOU WERE NEXT. >> SO I JUST WANT TO EXPAND ON THAT BECAUSE I THINK IT'S SO CRITICAL, AND I'LL JUST -- ANECDOTE, DECEMBER 31, I DID MY CME MEDICAL LICENSE RENEWAL FOR PENNSYLVANIA, AND IT'S ALL ABOUT OPIOIDS, THERE'S THIS REQUIRED ELEMENT, AND I READ THROUGH IT AND IT'S GOOD. BUT THERE'S A LOT THAT COULD BE LEARNED. I THINK FROM INTERACTIONS WITH OTHERS. AND I IMAGINE EVERY STATE IS DOING THAT RIGHT NOW BECAUSE OF THE CRISIS. AND I THINK THAT THAT'S A COHORT THAT COULD REALLY BE EMBRACED BECAUSE I IMAGINE THE INFORMATION IS VERY DIFFERENT FROM STATE TO STATE TO STATE. AND THIS IS SOMETHING THAT I THINK IF THERE WAS SOME COMMON BASIS JUST LIKE FOR ACGME OR AAMC FOR TRAINEES I THINK THE POPULATION WE'VE GOT TO INCLUDE ARE THE PHYSICIANS. >> THANK YOU FOR EXPANDING ON THAT. OKAY. I'VE LOST TRACK WHO IS NEXT. OKAY. LET'S GO AROUND THE ROOM. THERE AND I DON'T KNOW, JIM, TELL ME IF WE'RE RUNNING OUT OF TIME. YEAH, PLEASE. EIGHT MINUTES, PLENTY OF TIME. >> I WANT TO ASK THE QUESTION, THERE IS A PROJECT CALLED PROJECT ECHO, I DON'T THINK IT'S THE SAME ECHO THAT YOU'RE TALKING ABOUT HERE, THAT HAS BEEN FOCUSING ON HELPING TO TRAIN PRACTICING PHYSICIANS AND PROVIDERS. AND I'M WONDERING WHETHER -- AND THEY ARE DOING THIS, MOST OF THOSE PROGRAMS REALLY SUFFER IN TERMS OF BEING ABLE TO ADVANCE IN SEVERAL REASONS, ONE, THE WAY THAT THEIR BUSINESS MODEL IS SET UP THEY ARE DEPENDENT ON GRANTS IN ORDER TO EXIST. NUMBER TWO, I'M NOT TOTALLY FAMILIAR, THE AMOUNT OF SCIENCE THAT'S INTRODUCED INTO THE CURRICULUM OF THOSE PROGRAMS WHICH ARE ACTUALLY TRAINING PEOPLE WHO ARE OUT IN PRACTICE RIGHT NOW WHO ARE DEALING WITH THESE PATIENTS AND HAVE AN INTEREST IN UNDERSTANDING HOW TO DO THIS, I'M WONDERING IF THERE'S ANY OPPORTUNITY THERE TO INFUSE THE LATEST SCIENCE, INTO THAT TYPE OF FORMAT THAT MIGHT HELP AFFECT THOSE TREATING THESE PEOPLE NOW. >> THANK YOU FOR RAISING THAT. I'M UNFAMILIAR WITH THAT ECHO. THERE'S ANOTHER ECHO I'M FAMILIAR WITH BUT THAT ONE I'M NOT. I DON'T KNOW IF YOU'RE FAMILIAR, REBECCA. YOU DIDN'T KNOW YOU WERE GOING TO COME HERE TO WORK, DID YOU IN. >> IT'S A GREAT QUESTION. I THINK WHENEVER WE DO ENGAGE OUR PARTNERS, AS A FOLLOW-UP, DR. TABAK POINTED OUT THIS IS THE QUESTION, IF I HAVE THIS TYPE OF PATIENT WITH THESE INDICATIONS, WHAT IS THE BEST TREATMENT STRATEGY, WHAT ARE THE BEST PRACTICES, AND HOW CAN I JUSTIFY TO PAYERS OR SOMEONE ELSE INVOLVED. SO I THINK THAT PART OF OUR STRATEGY THROUGH "HEAL" IS TO GENERATE THOSE DATA AND TO WORK VERY CLOSELY WITH GRANTEES BUT ALSO WITH PARTNERS TO GET THAT INFORMATION IN A FORMAT THAT'S VALUABLE AND CAN BE EASILY UTILIZED SO THAT -- >> NOW WE'VE GOT TO COMPILE DATA, MAKE IT READILY ACCESSIBLE SO EVERYBODY KNOWS WHERE IT IS, AND REACH OUT TO PROGRAMS LIKE THIS ONE, WHICH AGAIN I'M NOT FAMILIAR WITH BUT TO REACH OUT AND SAY, HEY, HERE'S THIS OPPORTUNITY. YOU KNOW, SO OKAY. GOING AROUND THE ROOM. YES, PLEASE. >> MICHAEL AIRMORE, UC-DAVIS. WE TALKED ABOUT SOCIAL SCIENCES EARLIER TODAY, ON THE WORKING GROUP FOR A.I. I CAN'T TELL BUT ARE THERE SOCIAL SCIENTISTS INVOLVED AS WELL ABOUT THE ADVANCING BIOMEDICAL RESEARCH? >> OKAY, JESS, YOU'RE ON. JESS IS THE PERSON WHO IS WORKING WITH US ON THE -- I DON'T DO ANYTHING. I HAVE AMAZING PEOPLE THAT HELP ME. >> I THINK THAT POINT HAS BEEN RAISED WITH OTHERS THAT HAVE SEEN THIS LIST, AND THIS IS A THOROUGHLY NEW GROUP SO IT'S SOMETHING THAT WE'RE LOOKING TO EXPLORE GETTING SOMEWHERE ON IT. . >> IF YOU HAVE RECOMMENDATIONS FOR US LET JESS KNOW. THANK YOU. YES PLEASE. >> THANKS FOR THE COMPREHENSIVE PRESENTATION. MY QUESTION IS REGARDING SOME OF THE DATA YOU PRESENTED EARLY ON, WE HAVE SO FAR RECOVERED HALF OF THE LOSS. MY QUESTION IS WHETHER THE SUCCESS RATE OF R01 HAS BEEN RESTORED IN PROPORTION TO THAT AS YOU KNOW THAT BECAUSE OF THE DECREASED SUCCESS RATE OF R01, LOSING A LOT OF GREAT SCIENTISTS. >> YEAH, SO, YOU KNOW, SUCCESS RATE WHICH I KNOW IS WHAT EVERYBODY FOCUSES ON, I UNDERSTAND WHY, IS SUBJECT TO ONE ELEMENT THAT WE CAN'T I CAN'T CONTROL HOW MANY PEOPLE APPLY. AND SO, YOU KNOW, WE ARE A VICTIM OF OUR OWN SUCCESS. WE HAVE PRODUCED SO MANY HIGHLY QUALIFIED BIOMEDICAL RESEARCHERS, THAT THE NUMBER OF PEOPLE WHO APPLY KEEPS GOING UP AND UP AND UP. SO WE'RE TRYING TO PIVOT AWAY FROM SUCCESS RATE AS A METRIC OF SUCCESS, FOR WHAT WE ARE ABOUT. HOW MANY NEW INVESTIGATORS HAVE WE FUNDED? HOW MANY INDEPENDENT INDIVIDUALS HAVE WE FUNDED? I THINK THOSE ARE METRICS WHICH SHOW THAT IN FACT WE ARE MAKING PROGRESS. BUT SUCCESS RATE IS A BIT ARTIFICIAL BECAUSE ALL OF YOU HAVE SUCCESSFULLY RECRUITED AMAZING FACULTY WHO ARE APPLYING, YOU KNOW, MULTIPLE TIMES, SO IT BECOMES AN EXAGGERATED METRIC, THAT'S ONE PART OF THE EQUATION WE CAN'T CONTROL. IF YOU CAN'T CONTROL IT, YOU KNOW, IT'S A LITTLE DIFFICULT TO GET YOUR ARMS AROUND IT. I KNOW THAT'S NOT SATISFYING BECAUSE EVERYBODY WANTS THE SUCCESS RATE TO BE ABOUT 30%, WHERE , WHERE I THINK EVERYBODY AGREES THAT WOULD BE PERFECT BUT WE CAN'T CONTROL THE NUMBER OF PEOPLE APPLYING. >> BECAUSE THE MONEY BEING REDIRECTED TO OTHER FUNDING MECHANISM OR ACTUALLY MAY NOT BE THE CASE? >> WELL, SO, AGAIN, FOR EXAMPLE, THE HEAL INITIATIVE, THERE WILL BE MANY, MANY OPPORTUNITIES THERE FOR, YOU KNOW, R-TYPE PROGRAMS. AND SO THAT ALL GETS FED INTO THE SUCCESS RATE. SO I THINK IT MIGHT CONTRIBUTE SOMEWHAT, BUT NOT TO THE EXTENT MAYBE PEOPLE THINK IT IS. I THINK THE DRIVER THERE IS SO MANY MORE PEOPLE APPLYING. AND I DON'T THINK THAT'S A BAD THING NECESSARILY, BUT IT DOES EXAGGERATE A METRIC IN A WAY WE JUST CAN'T CONTROL. PLEASE. p>> MY COMMENT IS MORE A FOLLOW-ON TO DR. LAIRMORE ABOUT AT A.I. ISSUES. PEOPLE WERE ATTACKING SELF-DRIVING CARS IN CALIFORNIA, A THREAT TO LARGE SEGMENTS OF THE COMMUNITY. I DON'T SEE THIS GROUP NECESSARILY, STRUCTURED TO LOOK AT WHAT ARE THE OPPORTUNITY OR EXCITING DEVELOPMENTS BUT MAYBE AS A FOLLOW-ON ONCE WE GET SOME MAP OF WHERE THIS IS GOING, THIS REALLY MAY HAVE PROFOUND EFFECTS ON HOW MEDICINE AND SCIENCE ARE PRACTICED, THE NIH MIGHT BE WELL POSITIONED TO BEGIN TO ANTICIPATE HOW DO WE RESTRUCTURE WORKFORCES WITH THESE TECHNOLOGIES IN MIND. >> I WOULD OFFER THAT I THINK IT'S ALREADY BEGINNING TO INFLUENCE IN SOME PROFOUND WAYS HOW AT LEAST DIAGNOSTIC MEDICINE IS BEING PRACTICED IN SOME FIELDS, PARTICULARLY RADIOLOGY. I DON'T KNOW IF ANY OF YOU ARE RADIOLOGISTS, BUT THAT IN PARTICULAR IS ONE OF THE PLACES. SO YOU'RE A RADIOLOGIST. >> YEAH, LARRY, I HAVE A VERY UNRELATED QUESTION. >> GOOD. >> IS NIH DEVELOPING AN OPINION ON PLAN F? >> SO, WE ARE WORKING CLOSELY WITH OUR PARTNERS ACROSS THE GOVERNMENT. IT'S A LITTLE COMPLICATED RIGHT NOW BECAUSE SOME OF OUR PARTNERS ARE ON FURLOUGH BECAUSE OF THE PARTIAL LAPSE. AND SO HOPEFULLY ONCE EVERYBODY IS ALL BACK AT WORK, WE WILL BE ABLE TO HARMONIZE AND COORDINATE BECAUSE AS YOU KNOW THE PRINCIPLES ARE THINGS THAT NIH STANDS BEHIND. I'M SORRY, THIS IS OPEN ACCESS, IN EFFECT OPEN ACCESS OF THINGS THAT ARE PUBLISHED IN JOURNALS. BUT AS YOU WELL KNOW, THE DEVIL IS ALWAYS IN THE DETAILS, AND THERE ARE BUSINESS MODELS FOR CERTAIN JOURNALS THAT WOULD BE COMPROMISED IF ONE WERE TO FOLLOW THAT BY THE LETTER. NOW, THAT ALSO -- THAT PROPOSAL HAS ALSO BEEN EVOLVING A LITTLE BIT, AS YOU KNOW. AND SO THE HOPE IS THAT ONCE WE ALL GET OUR PARTNERS BACK ACROSS THE GOVERNMENT, WHAT WE'LL BE ABLE TO DO SOME ADDITIONAL WORK. >> THIS IS A PROPOSAL FROM EUROPEAN FUNDING, ORGANIZATIONS. >> I AGREE. AND I BRING IT UP BECAUSE I REALLY WORRY ABOUT SOCIETY JOURNALS. >> YEAH, EXACTLY RIGHT. NO, I MEAN, THAT'S A GOOD EXAMPLE OF A BUSINESS MODEL WHERE, YOU KNOW, IT COULD BE SEVERELY COMPROMISED. THE LAST WORD. >> I DON'T KNOW IF THAT'S APPROPRIATE FOR MY QUESTION. I HAVE A QUESTION, THINKING ABOUT A.I., HAVE YOU GIVEN ANY THOUGHT IF WE WANT TO PROMOTE THAT, DO WE DO SOMETHING SIMILAR TO THE ORIP AND INFRASTRUCTURE DEVELOPMENT TO START TO HAVE ALL OUR ACADEMIC PARTNERS BUILD THIS A.I. INFRASTRUCTURE IN SUCH A WAY TO ACCELERATE THIS INNOVATION? >> NO, THANK YOU, THAT'S A GREAT QUESTION TO BE THE LAST WORD ON THIS SET OF TOPICS. LOOK, I'M A FORMER RESEARCH DEAN. SO I LOVE INFRASTRUCTURE. ONCE A RESEARCH DEAN, ALWAYS A RESEARCH DEAN, OKAY? SO I LOVE INFRASTRUCTURE. AND SO, YES, I THINK THAT AT SOME POINT WHAT YOU WANT TO BE AUTOMOBILE TO DO IS YOU -- ABLE TO DO IS YOU WANT TO BE ABLE TO ENABLE THE WHOLE OF BIOMEDICAL RESEARCH. AND THE AMAZING THING ABOUT THINGS LIKE A.I. IS IT'S PRETTY LOW COST, RELATIVE TO SOME OTHER THINGS THAT BIOMEDICAL RESEARCH NEEDS TO DO A HEAVY LIFT ON. LOTS OF COMPLICATIONS BUT IN TERMS OF THE INFRASTRUCTURE, I THINK IT'S TRACTABLE. I THINK IT'S DOABLE. I THINK, YOU KNOW, NOT EVERYBODY CAN AFFORD HOWEVER MANY THOUSAND MEGAHERTZ NMRs WE HAVE THESE DAYS, BUT THIS STUFF, I THINK IT'S TRACTABLE, SO I THINK IT'S A VERY IMPORTANT QUESTION AND ONE THAT WE ARE GOING TO KEEP AT THE FOREFRONT AS WE START DEVELOPING WAYS FORWARD. AGAIN, I KNOW I'VE OVERSPENT MY WELCOME BUT I WANT TO THANK YOU ALL, AND HOPE THE REST OF YOUR MEETING IS VERY PRODUCTIVE. >> THANK YOU SO MUCH, LARRY. [APPLAUSE] THAT CONCLUDES THIS MORNING'S SESSION. >> WELCOME BACK. OUR OPEN SESSION IS NOW IN SESSION. WE HAVE THREE PRESENTATIONS THIS AFTERNOON, WE'LL START OUT WITH A CONCEPT CLEARANCE. THIS IS FOR A PROGRAM AND ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES. THIS IS OUR ECHO PROGRAM. THE TITLE OF THE PRESENTATION IS IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK AND THIS IS A RENEWAL OF SOMETHING THAT STARTED RELATIVELY RECENTLY. DR. ALAN SIMON WHO IS MEDICAL OFFICER IN THE IDEA STATES NETWORK IN ECHO IS GOING TO PRESENT THE CONCEPT AND WHAT WE'LL ASK YOU TO DO IS A MOTION TO APPROVE THE CONCEPT, PLEASE ASK A LOT OF QUESTIONS TO MAKE SURE YOU UNDERSTAND WHAT THE PROGRAM LOOKS LIKE. >> EVERYONE HEAR ME? SO THANK YOU GUYS FOR HAVING US HERE TODAY TALK ABOUT OUR CONCEPT PROPOSAL FOR THE RENEWA OF THE IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK. WE ARE HERE TO SEEK CONCURRENCE AND FEEDBACK TO HELP GO FORWARD WITH THIS PROJECT. THE IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK OR ISPCTN IS TWO MAYBE COMPONENT OF THE ECHO PROJECT. ONE COMPONENT IS ECHO COHORT, OBSERVATIONAL SCIENCE SIDE OF THE PROJECT. THE NETWORK OR ISPCTN IS THE INTERVENTIONAL SCIENCE SIDE OF THE PROJECT. WE WERE FUNDED FOR FOUR YEARS STARTED IN 2016 WHEN THE NIH RECOGNIZED THE NEED FOR VULNERABLE CHILDREN FROM RURAL UNDERSERVED BACKGROUNDS TO HAVE ACCESS TO STATE-OF-THE-ART CLINICAL TRIALS. THE PROGRAM WAS PLACED IN THE OFFICE OF DIRECTOR UNDER THE ECHO PROGRAM AND HENCE WE SERVED THE GREATER MISSION OF ECHO WHICH IS TO ENHANCE CHILDREN FOR GENERATIONS TO COME BUT THE NETWORK HAS SPECIFIC GOALS TO PROVIDE MEDICALLY UNDERSERVED URBAN RURAL POPULATIONS ACCESS TO STATE-OF-THE-ART CLINICAL TRIALS AND BUILD PEDIATRIC RESEARCH CAPACITY IN THE IDEA STATES. THESE NOT A POLITICAL MAP THOUGH USE RED AND BLUE. IF RED AND BLUE TOGETHER REPRESENT IDEA STATES. THOSE ARE STATES WHICH HISTORICALLY HAD LOW LEVELS OF NIH FUNDING. AND HENCE THE IDEA PROGRAM BUILDS RESEARCH CAPACITY IN THOSE STATES AND ENHANCES THE ABILITY OF INVESTIGATORS IN THOSE STATES TO COMPETE SUCCESSFULLY FOR ADDITIONAL RESEARCH FUNDING. IT ALSO SERVEDDED THE RESEARCH NEEDS OF MEDICAL COMMUNITIES IN THOSE STATES. THE RED STATES ARE THE 17 STATES IN WHICH OUR NETWORK CURRENTLY HAS A SITE AND THAT INCLUDE ARKANSAS, WHERE OUR DATA COORDINATION OPERATION CENTER IS, UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES, SUPPORTED BY THE OVERALL ECHO COORDINATING CENTER AT DUKE CLINICAL RESEARCH INSTITUTE. SO WHAT HAVE WE ACCOMPLISHED -- GO BACK, ONE SECOND. SORRY ABOUT THAT. SO I ALSO WANTED TO MENTION THOUGH YOU CAN SEE THAT THE RED AND BLUE STATES TOGETHER MAKE UP THE IDEA STATES THEY TEND TO BE VERY RURAL STATES THOUGH NOT EXCLUSIVELY. AND THOUGH THERE ARE MANY IDEA PROGRAMS, THE IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK IS UNIQUE AMONG IDEA PROGRAMS IN THAT WE'RE THE ONLY CLINICAL TRIALS NETWORK AND WE'RE THE ONLY PEDIATRIC FOCUSED PROGRAM AMONG THE IDEA PROGRAMS. SO WHAT HAVE WE ACCOMPLISH IN TWO SHORT YEARS SINCE WE BEGUN? QUITE A BIT. WE HAVE TWO ONGOING CLINICAL TRIALS BOTH PHARMACOKINETIC TRIALS, FIRST CALLED POPS IS THE STUDIES PHARMACO KIP TICKS IN UNDERSTUDIED DRUGS IN PEDIATRICS. IT'S A PEDIATRIC TRIALS NETWORK PROJECT AND WE LEVERAGE THEIR INFRASTRUCTURE, THEIR NICHD NETWORK, WE LEVERAGE THEIR INFRASTRUCTURE AND GOT ALL OUR SITES INVOLVED RIGHT FROM THE START WITH THE IDEA OF SHOWING THEM EXACTLY WHAT IT TAKES AND HOW HARD IT IS TO GO AHEAD AND DO MULTI-CENTER CLINICAL TRIALS, IT'S BEEN A GREAT LEARNING EXPERIENCE FOR US. THE OTHER PHARMACOKINETIC TRIAL STUDIES VITAMIN D IN CHILDREN WITH OBESITY AND ASTHMA. THE HOPE OF THAT IS BY UNDERSTANDING THE PHARMACOKINETICS THERE BETTER WE'LL MOVE TO A LARGER TRIAL. WE ALSO HAVE SEVERAL OPIOID RELATED PROJECTS AS PART OF THE NIH HEEL INITIATIVE YOU HEARD ABOUT EARLIER TODAY. THESE ARE THE AT NOW PROJECTS THAT LARRY TABAK MENTIONED EARLIER. AND THESE ARE BEING DONE IN CONJUNCTION WITH THE NICHD RESEARCH NETWORK, WE HAVE BEEN LEVERAGING THEIR EXPERIENCE AND EXPERTISE IN THIS AREA TO GET THESE DONE. THE FIRST PROJECT IS ACTUALLY AN OBSERVATIONAL STUDY, A MEDICAL RECORD ABSTRACTION OF INFANTS WITH NEONATAL OPIOID WITHDRAWAL SYNDROME ACROSS 30 HOSPITALS IN THE US. IN BOTH NETWORKS. AND WE'RE VERY EXCITED, WE HAVE COMPLETED THE COLLECTION AND MOVING ON TO ANALYSIS JUST NOW. THE GOAL WAS TO UNDERSTAND THE CARE INFANTS WITH NEONATAL OPIOID WITHDRAWAL SYNDROME ARE RECEIVING AND ALSO TO HELP US GET THE INFORMATION WE NEED TO BUILD TWO ADDITIONAL CLINICAL TRIALS. THOSE ARE UNDER DEVELOPMENT RIGHT NOW. WE ALSO HAVE MULTIPLE PILOT PROJECTS IN DEVELOPMENT AS WELL. OUR NETWORKS DONE A LOT OF CAPACITY BUILDING AT OUR SITES. TURNS OUT THE BEST CAPACITY BUILDING WE HAVE DONE IS THE BUILDING AND THE DEVELOPMENT IMPLEMENTATION OF CLINICAL TRIALS I MENTIONED THAT SEEMS TO WORK THE BEST. BUT WE HAVE DONE MORE THAN THAT AS WELL. WE LIKE TO THINK OF OUR CAPACITY BUILDING IN TERMS OF THE FRAMEWORK OF STRUCTURE PROCESS AND OUTCOME. IN TERMS OF STRUCTURE WE HAVE BUILT GREAT KNOWLEDGE AND INCREASE STAFF AT DATA COORDINATION OPERATION CENTER, WE BUILT RESEARCH TEAMS AT ALL CLINICAL SITES AND PROVIDED THEM WITH EQUIPMENT AND SPACE IN TERMS OF PROCESS WE CREATED GOVERNANCE PROCESSES FOR THE WHOLE NETWORK AND SINGLE IRB MECHANISM WHICH IS SOMETHING THAT ALL NETWORKS ARE TRYING TO GET TO AND WE THINK WE HAVE GOTTEN THERE. WE HAVE ALSO COLLABORATED WITH OTHER IDEA PROGRAMS AS WELL AS THE ECHO COHORTS. IN TERMS OF OUTCOMES AS I MENTIONED, OUR TRIALS ARE BEST OUTCOME, THAT'S SORT OF THE THING THAT I THINK IS MOST IMPORTANT. WE HAVE STARTED CONDUCTING ANALYSES ON THE DATA WE HAVE COMING IN. AS WELL SOME QUALITY ASSURANCE DATA WE WORKED AT DURING WE COLLECTED DURING THE DATA COLLECTION. WE HAVE POSTERS AND PRESENTATIONS AND WE'RE GOING TO HAVE TWO PRESENTATIONS PEDIATRIC ACADEMIC SOCIETIES THIS YEAR AND WORKSHOP AS WELL. AND MANUSCRIPTS UNDER DEVELOPMENT AS WELL. WE ALSO MONITOR THE GRANTS THAT ARE INVESTIGATORS ARE SUBMITTING BECAUSE WE WANT TO KNOW THEY ARE PROGRESSING THE WAY WE HOPE THEY ARE. WE THINK WE HAVE BEEN GOING GREAT BUT WANT TO BUILD SUCCESS GOING FORWARD AND THERE'S STILL WORK TO BE DONE. CERTAINLY CHILDREN RURAL COMMUNITIES AND IDEA STATES STILL EXPERIENCE WORSE HEALTH OUTCOMES AND UNDER-REPRESENTED IN CLINICAL TRIALS. IDEA STATES INSTITUTIONS CONTINUE TO NEED MORE CAPACITY BUILDING AND PROFESSIONAL DEVELOPMENT TO LEARN HOW TO DEVELOP IMPLEMENT CLINICAL TRIALS. THIS IS MY OWN ANALYSIS FROM THE DATA NIH REPORTER WEBSITE. APPROXIMATELY 1.9 BILLION IN GRANT FUNDING GOES TO IDEA STATES COMPARED WITH 25 BILLION THAT NIH GRANT FUNDING GOES TO NON-IDEA STATES SO GIVES YOU SOME IDEA OF THE GAP THAT IS STILL THERE. SO OUR APPROACH TO NETWORK RENEWAL? WE PLAN TO REMAIN CURRENT SIZE, 17 CLINICAL SITES AND ONE DATA COORDINATION OPERATION CENTER WE PLAN FOR OPEN COMPETITION AMONG ALL STATE INSTITUTIONS. WE WOULD LIKE TO REMAIN A COOPERATIVE AGREEMENT, WE TALK ABOUT THREE LEGGED STOOL OF NIH DATA COORDINATION OPERATION CENTER AND CLINICAL SITES AND WE FOUND THIS STRUCTURE WORKS WELL TO KEEP EVERYBODY ON THE RIGHT PATH. WE ARE AIMING FOR FIVE YEARS AS I MENTIONED ALREADY THEY'RE OVERLAPPING BUCKETS BUT IT IS A HELPFUL FRAMEWORK TO THINK ABOUT IT THAT WAY. FOR CLINICAL TRIALS, WE AIM FOR MINIMUM THREE MULTI-CENTER CLINICAL TRIALS OVER FIVE YEARS. WE WANT DATA COORDINATION OPERATION CENTER TO CONTINUE PROVIDING RESOURCE ALLOCATION FOR TRIALS, DATA ANALYSIS AND DATA SHARING WE ALSO WANT THEM TO CONTINUE TO HELP WITH PROTOCOL DEVELOPMENT THAT'S SOMETHING WE FOUND IS VERY USEFUL TO HAVE THAT SUPPORT FOR THE CLINICAL SITES AND THEIR DEVELOPMENT OF PROTOCOLS. HOUR CLINICAL SITES WILL CONTINUE TO DEVELOP IMPLEMENT TRIALS BUT PART OF THE APPLICATION WE WANT THEM TO PROPOSE PROTOCOL FOR MULTI-CERTAINTY TRIAL AND THE REASON FOR THAT IS SO WE CAN MAKE SURE WE'RE GOING TO GET CENTERS SUCCESSFUL WITHIN NETWORK, THEY'RE STRONG CENTERS. AN AREA WE THINK WE CAN DO BETTER IS AS MENTIONED WE'RE IN RURAL STATES BUT WE STILL SOMETIMES THINK WE CAN DO BETTER ENGAGING RURAL COMMUNITIES WITHIN THOSE STATES. IN THE CLINICAL TRIALS SO WE WANT EVERYONE TO PROPOSE AND IMPLEMENT A PLAN TO ENPHAGOIN RURAL COMMUNITIES IN TRIALS. IN TERMS OF CAPACITY BUILDING WE WANT CLINICAL SITES AND DATA COORDINATION OPERATION CENTER TO PROPOSE IMPLEMENT CAPACITY BUILDING PLAN NOT JUST FOR JUNIOR AND SENIOR FACULTY BUT ALSO RESEARCH COORDINATORS. THE RESEARCH COORDINATORS ARE ABSOLUTELY ESSENTIAL TO GETTING MULTI-CENTER TRIALS DONE SUCCESSFULLY AND WE THINK THEY SOMETIMES GET LEFT BEHIND IN TERMS OF PROFESSIONAL DEVELOPMENT SO INCLUDE THEM AND BRING THEM IN TO THE PROCESS. WE WANT OUR CENTERS TO COLLABORATE WITH PEOPLE WHO HAVE BEEN SUCCESSFUL IN RESEARCH BEFORE SO THE IDEA PROGRAM OR ONE IDEA PROGRAM IS INFRASTRUCTURE FOR CLINICAL TRANSLATIONAL RESEARCH AWARDEES, VERY MUCH LIKE CTSAs, CLINICAL TRANSLATIONAL SCIENCE AWARD, INSTITUTIONS, AND AN APPLICANT PROPOSE COLLABORATING WITH EITHER OF THESE WITHIN THEIR STATE, MAYBE DON'T HAVE ONE OF THESE IN THEIR STATE WHICH CASE THEY CAN PROPOSE OTHER COLLABORATORS AS WELL BUT MAJORITY HAS TO STAY WITHIN THE YOURS TRULY STAID, WE DON'T WANT IT TO BE A PASS LARGER NON-IDEA STATE INSTITUTIONS BECAUSE THAT WOULDN'T BE THE PLAN. SO WE THINK WITH THIS COMBINATION OF CLINICAL TRIALS AND CAPACITY BUILDING WE THINK WE CAN BE SUCCESSFUL IN CONDUCTING A SCIENCE THAT IMPROVINGS THE HEALTH H OF THE CHILDREN. BUT ALSO WE CAN CREATE A WORK FORCE INFRASTRUCTURE TO CONDUCT THE SCIENCE AND IDEA STATES. AND ADDRESS THE NEEDS OF THE UNDERSTUDIED POPULATION. SO THAT'S IT. WE ARE LOOKING FOR APPROVAL AND WE ARE OPEN FOR DISCUSSION. BE BEST IF I GO AROUND. >> I HAVE TWO QUESTIONS REGARDING THE CLINICAL TRIALS EFFORT. YOU EMPHASIZED RESEARCHERS, FACULTY MEMBER AND SO FORTH. BUT WHAT ABOUT THE PRACTICING CLINICIAN WHO IS IN THE TRENCHES MORE OR LESS DOING THE WORK? AND THEN THE SECOND QUESTION IS RELATED TO THE PATERS. FOR -- THE PATIENTS. FOR MANY OF THESE CHILDREN THE PARENTS DOSE HAVE RESOURCES TO BRING THEM TO THE CENTER TO COLLECT THE INFORMATION ON ARE YOU MANAGING OUT OF POCKET COSTS TO ENSURE THAT YOU COLLECT THE DATA POINTS, THOSE TWO QUESTIONS, PLEASE. >> YOU SHOULD BE STANDING UP HERE. THOSE ARE BOTH FANTASTIC POINTS. LET ME TAKE THE SECOND ONE FIRST. ONE OF THE PILOT PROJECTS THAT WE HAVE BEEN THINKING ABOUT IS ACTUALLY TO BETTER IDENTIFY WHAT ALL BARRIERS ARE FOR OUR COMMUNITIES AND OUR PATIENTS. SO THERE'S SOME SURVEY WORK BEING IN DEVELOPMENT THERE. ONE OTHER APPROACH, I WOULD LIKE TO HEAR YOUR IDEAS ABOUT APPROACHES BUT ONE APPROACH THAT WE HAVE SEEN, OTHER THAN NEONATAL RESEARCH IS TOWARDS PEOPLE WITH ADDITIONAL BARRIERS AND COSTS IS IF SOMEBODY HAS TO TRAVEL PARTICULARLY LONG WAY, THE RESEARCHER CAN PUT IN FOR EXTRA COMPENSATION FOR THAT PATIENT. SORT OF A BY PATIENT THING SO SOMETHING WE THOUGHT ABOUT, CERTAINLY NOT PROBLEM WE COMPLETELY SOLVE, LIKE THE HEAR IF YOU HAVE OTHER IDEAS ABOUT THAT. IN TERMS OF CLINICIAN, THAT'S A GREAT POINT. WITH EACH NEW TRIAL YOU HAVE TO THINK ABOUT THAT, ONE THING I WOULD POINT OUT IS IN BUILDING CAPACITY, IF YOU THINK ABOUT JOHNS HOPKINS TYPE AREA WHERE CLINICS HAVE OPPORTUNITY THIS A LOT OF TIMES MAYBE USED TO IT IN YOU ARE AREAS, NEIGHBOR NOT. BUT WE PULL IN WITH EACH NEW TRIAL ABLE TO PULL IN RESEARCHERS SO GOING TO POINT OUT BOTTOM TWO, THESE ARE THE TWO THINGS GOING IN THE FIELD WITH MEDICAL RECORD ABSTRACTION AND SECOND IS VITAMIN D, JUST ENTERING THE FEEL NOW AND YOU CAN SEE THE NEW FACULTY THAT WE'RE PULLING IN TO EACH PROJECT. WE DO HAVE TO TRAIN THEM AND CONSIDER HOW THEY'RE GOING TO GO FORWARD. >> THANK YOU VERY MUCH. WE CAN TALK OFFLINE, I HAVE SOME EXPERIENCE WITH THIS IN CANCER CLINICAL TRIALS WHERE WE ARE PROVIDING THE CLINICAL TRIALS THROUGHOUT THE COUNTRY FOR THE PATIENT. WE CAN TALK OFFLINE. >> I NOW UNDERSTAND THIS IS A DIFFERENT ECHO ALL TOGETHER. INSIDE JOKE NOW. THANK YOU VERY MUCH. I APPRECIATE YOUR PRESENTATION. I'M IN IDAHO. ONE OF YOUR STATES BUT NOT ONE FUNDED AT THIS POINT SO I'M GOING BACK HOME TO FIND OUT WHAT THE HECK WENT ON. THIS DIDN'T HAPPEN. MY CONCERN AND I CAN UNDERSTAND FROM YOUR PERSPECTIVE OF THIS BECOME A PROJECT GOING FORWARD, YOU HAVE TO HAVE SOME LEVEL OF CONSISTENCY BUT I HAAR YOU SAY YOU'RE NOT EXPANDING THE SITES UP FOR YOUR CLINICAL TRIALS SITES AT THIS POINT, YOU HAVE 17 I THINK, THAT'S AS FAR AS YOU GO. THE REASON I ASK IS THAT IN NOT TO KIND OF LIKE IDAHO BUT I HAVE TO BE CLEAR THAT IT'S PROBABLY NOT UNIQUE TO OTHER STATES THAT HAVE QUITE A FEW RURAL AREAS. IN IDAHO THERE'S 44 COUNTIES, 35 RURAL AND 15 ARE FRONTIER SO THAT MEANS THAT YOU HAVE SIX OR LESS PEOPLE PER SQUARE MILE IN AN AREA. TRANSPORTATION OR GETTING ACCESS IS A HUGE ISSUE. AND ALSO HAVING HOW WOULD YOU SAY, EXTENSIONS TO THOSE COMMUNITIES WHICH ARE VERY DIFFERENT THAN I WOULD SAY THE URBAN AREAS IN A QUOTE UNQUOTE RURAL STATE. SO BOISE IS DIFFERENT THAN ARCO, IDAHO IN MANY RESPECTS AND WE'RE LOOKING AT CLINICAL OUTCOMES FROM THEM AND VERY DIFFERENT. THERE'S A LOT OF DISPARITIES BEING PICKED UP SO PART OF WHAT I'M ASKING IS TWO THINGS. ONE,, A STATEMENT HAS NOT PARTICIPATED, IS THERE A WAY FOR THEM TO PARTICIPATE NOW THROUGH SOME COLLABORATION? NUMBER ONE. NUMBER TWO, ARE YOU ACTUALLY RECRUITING CHILDREN IN ACTUAL RURAL AREAS OR ARE YOU COLLECTING THEM IN A RURAL STATE BUT ACTUALLY IN AN URBAN AREA. >> RIGHT. SO LET ME ANSWER THE SECOND PART FIRST. WHICH IS THAT'S SOMETHING THAT WE'RE -- WE'RE VERY EARLY ON. WHAT WE ARE DOING INITIALLY IS TRACKING TO SEE WHERE PEOPLE COME FROM. RIGHT NOW, AT OUR VERY EARLIEST DATA COMING IN FROM MEDICAL RECORD ABSTRACTION, IT LOOKS LIKES WE SORT OF LOOK LIKE THE BREAKDOWN OF THE COUNTRY IN TERMS OF PERCENT RURAL, PERCENT URBAN DEPENDING HOW YOU MEASURE. WHICH IS PROBABLY MY GUESS IS A LITTLE BETTER THAN WHAT OTHER PEOPLE HAVE DONE. BUT WE ARE REALLY TRYING TO THINK ABOUT HOW TO SPREAD OUT TO GET EXACTLY WHAT YOU ARE TALKING ABOUT, GET THE PEOPLE WHO ARE RURAL. I THINK IT'S NOT SOMETHING WE COMPLETELY SOLVED YET BUT SOMETHING WE WHERE THINKING ABOUT. GOING BACK TO THE FIRST PART OF YOUR QUESTION ABOUT THE STATES, IT WOULD BE OPEN COMPETITION AMONG IDEA STATES. IDAHO CAN APPLY. IN TERMS OF THE THE NUMBER WE ARE NOT -- I DON'T THINK THERE'S A MAGIC NUMBER HERE HOW MANY WE SHOULD BE EXACTLY. WE CAN TALK MORE ABOUT THAT. >> MAYBE STATING THE OBVIOUS BUT HAVE YOU USED ANY PCORI RESOURCES SUCH AS PCORNET? THERE'S A CLINICAL RESEARCH DATA NETWORK CALLED PEDES NET WIDE ARE NOT PROBABLY AN IDEA STATES BUT THERE'S A LOT OF REQUIREMENTS FROM PCORI TO WORK WITH THIS UNDERSERVED POPULATION IN TERMS OF PCORI WAS BUILT TO BUILD CLINICAL TRIALS. WONDER IF YOU HAVE USED OTHER TOOLS TO FIND PATIENTS. >> NOT YET BUT ONE OF THE PEDE NET PI IS CHRIS TORIES, HE'S AN ECHO GUY. I TALKED TO HIM BRIEFLY ABOUT IT BUT NOT YET, I THINK THAT'S SOMETHING WE CAN DEFINITELY LOOK INTO. I DON'T KNOW HOW MANY OUR SITES CURRENTLY OVERLAP BUT IF THERE MIGHT BE A WAY -- >> HE WOULD KNOW BETTER THAN ME SO YOU ARE TAPPED IN. GREAT. THANKS. >> I WANT TO ASK ABOUT THE RELATIVE BENEFITS TO THE STAKEHOLDERS HERE, I SEE THE BENEFITS FOR THE RESEARCH COMMUNITY AND THE AVAILABILITY OF RESOURCES HERE. I'M NOT SURE WE SEE THE ANGLE FOR THE KIDS IN THE UNDERSERVED COMMUNITIES HERE. IT'S HARD TO DESCRIBE RESEARCH AS A BENCH MAYBE IT'S A BENEFIT BUT MAYBE IT'S A HARM, WE DON'T KNOW. FREQUENTLY. ARE THESE RESEARCH QUESTIONS DESIGNED SPECIFICALLY TO ANSWER QUESTIONS ABOUT THE UNDERSERVED NATURE OF THESE COMMUNITIES AND WILL THE RESULTS OF THE STUDIES BE GENERALIZABLE TO OTHER UNDERSERVED KIDS OR KIDS IN GENERAL? HOW ARE YOU FOCUSING THE RESEARCH QUESTIONS BASED ON THE NATURE OF THE POPULATION? >> GREAT QUESTION. I THINK IT'S -- A LITTLE BIT OF EVERYTHING. DEFINITELY SOMETHING WE THINK ABOUT, WE WANT TO MAKE SURE WE ARE ASKING QUESTIONS THAT ARE RELEVANT TO COMMUNITIES WE ARE IN. CERTAINLY WE THINK ABOUT WHETHER THE QUESTION IS RELEVANT PARTICULARLY RURAL COMMUNITIES, IT'S HARD TO -- THE ONLY REASON I'M THINKING TWICE ABOUT THIS I GUESS BUT IT'S SOMETHING WE ARE DEFINITELY THINKING ABOUT. AT THIS STAGE WE'RE TRYING TO GET THIS UP OFF THE GROUND AND MAKE SURE OUR SITES KNOW HOW TO DO CLINICAL TRIALS WELL. SO SOMETIMES WE HAVE TO BALANCE THOSE THE DIFFERENT PRIORITIES THAT WE HAVE. IN THE NETWORK. >> A GUESS TO FOLLOW-UP QUICKLY. I'M NEW TO THIS CONCEPT SO WANT TO BE CAREFUL BUT OBVIOUSLY THERE'S LONG STANDING CONCERNS ABOUT CONDUCTING RESEARCH IN EASTERN EUROPE AFRICA AND PLACES WHERE THERE'S UNDERSERVED POPULATIONS AND THAT CAN BE DONE AS WAY OF TAKING ADVANTAGE OF THEIR UNDERSERVED NATURE TO ANSWER QUESTIONS FOR DRUGS YOU WILL SELL TO OTHER PEOPLE AND YOUR RESEARCH POPULATIONS, GOING TO SEE LONG TERM BENEFITS SO THE QUESTION IS, HOW TO THINK THROUGH THE YIELD FROM THIS RESEARCH IS GOING TO RETURN TO THE KIDS AND FAMILIES PART OF RESEARCH AND NOT JUST USE TO SELL DRUGS. >> DEFINITELY CONSCIOUS OF THAT. >> SO I WANT TO ASK CLEARLY YOU'RE -- YOUR GOAL SO DEVELOP INFRASTRUCTURE FOR MULTI-CENTER TRIALS IN THESE PARTICULAR POPULATIONS. SO COULD YOU COMMENT ON WHAT MEASURES OR GENERAL APPROACH YOU HAVE TAKEN TO MAKING SURE OBJECTIVE BASED MEASURES AT THE DIFFERENT SITES ARE HARMONIZED? ALSO, WHAT HAVE BEEN THE APPROACHES FOR HARMONIZING THINGS IN MANY OTHER CLINICAL TRIALS ARE SUBJECTIVE ASSESSMENTS BUT HAVE PROFOUND IMPACT WHETHER YOU GET TO THE TRUTH IF CLINICS IN DIFFERENT CENTERS THAT DON'T NORMALLY WORK TOGETHER ARE USING DIFFERENT METRICS TO EVALUATE? >> I WANT TO MAKE SURE I'M UNDERSTANDING YOUR QUESTION CORRECTLY. DO YOU MEAN IN CONTEXT OF PARTICULAR TRIAL LIKE A CERTAIN MEASURE WITHIN A TRIAL? TO MAKE SURE THEY'RE MEASURING IT THE SAME WAY? >> I THINK ONE QUESTION WOULD BE IS ARE YOU USING CENTRALIZED LABS FOR THE TRIALS? WOULD BE FOR LABORATORY BASED ASSAYS. THEN HOW HAVE YOU APPROACHED TRAINING THE ACTUAL OBSERVERS AND FOR EXAMPLE HOW THEY RATE BEHAVIORS OR EXAMS AND THINGS LIKE THAT. >> RIGHT. YEAH. NO, THOSE ARE ALL GREAT POINTS, SOMETHING WE THINK A LOT ABOUT. IN OUR VITAMIN D WE USE CENTRAL LAB EXCEPT THE ONLY EXCEPTION TO THAT IS OUR INITIAL SCREENER TO MAKE SURE PEOPLE -- ARE ELIGIBLE BUT BEYOND FOR THE ACTUAL MEASURES WE WANT TO USE CENTRAL LAB. WE ARE DEFINITELY VERY CONCERN ISED ABOUT MAKING SURE WE HAVE CONSISTENT MEASURES AND IN TERMS OF HOW THE STUDY IS CARRIED OUT, WE DO HAVE TO DO A LOT OF TRAINING OF OUR SITES, THERE'S A ROT CAPACITY BUILDING GOING ON WITH THAT AND OUR DATA COORDINATING CENTER SO FAR IS DOING A REALLY GOOD JOB OF THAT. IT TAKES I WOULD AGREE, IT TAKES A LOT OF WORK TO MAKE SURE EVERYBODY IS DOING THINGS THE SAME WAY. IT'S SOMETHING WE KEEP AN EYE ON CLOSELY. >> ONE MORE HERE. >> I ALSO WANTED TO FOLLOW-UP WHAT RHONDA WAS SAYING AND FOR EXAMPLE THE CHILDREN IN HONOLULU VERSUS BIG ISLAND, WHICH ARE RURAL COMMUNITIES. IT LOOKS LIKE THE RED STATES SEEM TO HAVE LARGE AGRICULTURAL ECONOMIES AND HAVE YOU CONSIDERED LOOKING AT UNIFORM EXPOSURES WITH REGARDS TO PESTICIDE AND RELATIONSHIP TO ASTHMA. >> WE THOUGHT A LITTLE BIT ABOUT THAT. I THINK ONE OF THE IDEAS WE HOPE TO EXPAND UPON IS LEVERAGE OUR RELATIONS WITH ECHO COHORTS. WE HAVE STRONG RESEARCHERS WHO HAVE DONE PESTICIDE WORK. WE DON'T -- WE NEED TO LEVERAGE THAT TO GET AT THAT TYPE OF QUESTIONS. ASTHMA OR RESPIRATORY DISEASE BUT MOSTLY ASTHMA IS ONE FOCUS AREA. THAT IS SOMETHING FOR DOWN THE ROAD, GETTING AT THAT SPECIFIC QUESTION. IT IS NOT IN OUR NEAR TERM BUT HOPEFULLY SOMETHING IN OUR FURTHER TERM. >> JUST ONE OTHER QUESTION. WHEN YOU TALK ABOUT RURAL COMMUNITIES THERE ARE A LOT OF DEMOGRAPHICS THAT MAKE IT VERY DIFFERENT DIFFERENT IMMUNITIES LOOK VERY DIFFERENT FROM THE STANDPOINT OF VIEW OF AGRICULTURAL BACKGROUND OR IF THERE'S MINING AND OTHER TYPES OF INDUSTRIES THAT ARE THERE. BUT ALSO THE ECONOMIC BALANCE GOING ON. WHAT I'M BACKING INTO IS ASKING ARE YOU COLLECTING INFORMATION ON THE GEOGRAPHY THAT THE INDIVIDUALS LIVE IN AND IS THAT FACTORED INTO YOUR ANALYSIS OF POTENTIAL OUTCOMES >> I THINK IT WILL DEPEND ON THE TRIAL, THE SPECIFIC TRIAL WE ARE DOING. I THINK THAT'S SOMETHING WE'LL DEFINITELY TRY TO KEEP IN MIND AS WE DESIGN EACH TRIAL ESSENTIALLY. I THINK WE'LL THINK MORE ABOUT THAT. >> SO MUCH IS BEING SAID THAT YOUR HEALTH IS DEPENDNT UPON GEOGRAPHY ZIP CODE YOU LIVE IN. I'M WONDERING WHETHER OR NOT THAT'S FACTORED INTO -- >> IT'S ABSOLUTELY SOMETHING WE ARE THINKING ABOUT. BUT IN TERMS OF WHAT WE'RE DOING IN A SPECIFIC TRIAL, WHAT EXPOSURES AND WHAT US THINGS WE WANT TO COLLECT WILL VARY. IT'S AN ABSOLUTELY RIGHT, EVEN WHEN WE TALK RURAL COMMUNITIES, IT'S ALMOST THE FIRST THING THAT COMES UP WHICH IS THERE'S NO SUCH THING AS ONE RURAL COMMUNITY. THEY HAVE -- THERE'S DIFFERENCE IN BETWEEN AND WE HAVE TO THINK ABOUT THAT. >> YOU HAVE BEEN USING THE TERM RURAL BUT THE FEDERAL GOVERNMENT HAS MANY DIFFERENT DEFINITIONS. I WONDER WHICH IS YOUR FOCUS. >> YEAH. SO THAT'S A GREAT QUESTION. AND ONE THAT'S NEAR ABOUT DEAR TO MY HEART AS A DATA PERSON FROM THE PAST. THE ONE WE HAVE BEEN RELYING ON NOW ARE ROCKET CODES, BECAUSE THOSE ARE SPECIFICALLY DESIGNED TO GET AT RURALITY VERSUS URBAN INFLUENCE CODES OR NCHS OR URBAN RURAL CODING. WE HAVE BEEN DOING THOSE AT ZIP CODE LEVEL SO THAT'S WHAT WE HAVE BEEN USING NOW BUT I DON'T THINK WE'S 100 PERSIAN SETTLED ON THE FORESEEABLE FUTURE. WE FOUND IT TO BE THE ONE USEFUL TO US NOW. IT'S A GREAT QUESTION AND SOMETHING WE WILL RE-EVALUATE WITH EACH NEW PROJECT. >> SO THIS IS A GREAT DISCUSSION. THANK YOU ALL FOR YOUR INPUT, INCREDIBLY HELPFUL. OUR ECHO COLLEAGUES SCRIBBLING AND WRITING INTENSELY. I ALSO SEE HOW ALAN CAREFULLY TRIED TO LISTEN TO WHAT YOU HAD TO SAY AND SURE THESE IDEAS WILL BE MAILED TO US, IT WILL BE DEVELOPED. SO WITH THAT, WHAT I HEARD, I HEARD NOBODY REALLY OBJECT TO THIS IDEA SO I'M GOING TO PUT THE MOTION FORWARD AND SEE WHAT HAPPENS. SO I'M GOING TO ASK IF THERE IS A MOTION ON THE TABLE TO APPROVE THE ECHO CONCEPT. FOR CLEARANCE OF THE RENEWAL OF THE IDEA STATE PEDIATRIC CLINICAL TRIALS NETWORK. IS THERE A SECOND? IS THERE ANY ADDITIONAL DISCUSSION? ALL THOSE IN FAVOR SAY AYE. >> AYE. >> ALL THOSE OPPOSED SAY NAY. ANY ABSTENTIONS? ONE, TWO. TWO ABSTENTIONS. THREE ABSTENTIONS. FOUR. IT WAS RHONDA, LINDA, GENE AND JEFFREY. ALL RIGHT. SO WITH THAT I WILL CALL THIS AS ACCEPTED. THE CONCEPT WAS CLEAR, ACCEPTED AND STAFF CAN MOVE FORWARD. I'M SURE WE WILL HEAR MORE UPDATES ON THIS PROGRAM. >> THE FOUR ABSTENTIONS IS SURPRISING, I WOULD LIKE TO KNOW -- WITHOUT PUTTING PEEP ON THE SPOT WHAT THE ISSUE IS. >> SOMEBODY WOULD LIKE TO COMMENT? >> I MAY BE CONFUSED BUT THOUGHT SINCE I WAS FROM A RURAL AREA VERY INTEREST IN THIS I NEED TO RECUSE MYSELF. >> THAT MAKES SENSE. CAN I ASK -- ADD SOMETHING? ALAN KIND OF SAID IT BUT I'M GOING TO ADD FOR CLARIFICATION, SO THEY SAID THERE ARE 17 SITES CURRENTLY, IT WILL BE AN OPEN COMPETITION. HE SAID THAT CLEARLY. THERE'S ABSOLUTELY NO GUARANTEE THAT THE 17 WILL BE FUNDED. THE BEST 17, SELECTED 17 WILL BE FUNDED ON THE TOP OR FOR WHATEVER REASON. COULD HAVE BEEN 17 EXISTING BUT COULD BE 17 NEW ONES, NOT LIKELY, I WANTED TO MAKE THAT CLEAR. >> WERE YOU ABSTAINING BECAUSE YOU THOUGHT YOU WERE IN CONFLICT? WE'RE IN CONFLICT WITH EVERY AREA. I THINK IF YOU'RE IN IN FAVOR OF THE PROPOSAL I THINK IT'S FAIR >> IF I'M IN FAVOR BUT ASKING THE QUESTION WHETHER OR NOT I NEED TO RECUSE MYSELF. >> I ABSTAIN FOR THAT SAME REASON BECAUSE I WAS AT THE UNIVERSITY OF HAWAII BEFORE AND I KEPT ADJUNCT APPOINTMENT THERE SO THOUGH I'M NOT PAY OR ANYTHING, I KNOW THE PEOPLE WHO HAVE THAT PROGRAM. SO I THOUGHT I SHOULD ABSTAIN. >> IN THIS CASE BECAUSE IT IS A CONCEPT CLEARANCE, THIS IS NOT THAT WE AWARD SOMETHING, WE CLEAR THE CONCEPT, THEN EVERYBODY IN THE IDEA STATES CAN APPLY THAT DOESN'T MAKE ANYONE MORE LIKELY SO FOR THAT REASON WE DIDN'T -- >> OKAY. >> SO TWO FEWER ABSTENTIONS. >> MY ABSTENTION IS MORE JUST SOME UNCERTAINTY ABOUT -- I DON'T OPPOSE IT BUT I'M UNCERTAIN ABOUT THE RELATIVE BENEFITS AND I DO SEE THE BENEFITS FROM RESEARCH COMMUNITY. I'M NOT CERTAIN HOW BENEFITS PLAY OUT THE KIDS AND FAMILIES, GIVEN ARE THESE RURAL ARE OR ARE THEY URBAN, URBAN KIDS IN RURAL STATES. WHAT BENEFITS DO WE REALLY ANTICIPATE COMING BACK TO PARTICULAR FAMILIES BY VIRTUE OF BEING GEOGRAPHIC AREAS. IS THE NETWORK DESIGNED TO ADDRESS CONCERNS AND PROVIDE BENEFITS BACK TO THEM. IT'S AN ELEMENT OF UNCERTAINTY IN THAT REGARD. >> I WOULD HAVE TO SAY THAT WAS THE SAME REASON I CHOSE STEPS. >> HELPFUL. THANK YOU. >> THANK YOU VERY MUCH. THAT WAS VERY CLEAR. AND DISCUSSION WAS HELPFUL. THEY LISTENED WE'RE GOING TO GO ON TO ANOTHER WORKING GROUP PRESENTATION AND FOR THE NEW MEMBERS I WANT TO DRAW A DISTINCTION HERE. THE ECHO PROGRAM USES THE COUNCIL OF COUNCILS TO PRESENT RECOMMENDATIONS AND CONCEPT CLEARANCE FUNDING BUT ALSO RECOMMENDATIONS TO THE NIH DIRECTOR AND ECHO DIRECTOR. THOSE OF US WHO WORK WITH IT. AND CONCEPT CLEARANCE, AN INVESTMENT IN A PARTICULAR AREA ONCE OUR JUSTIFICATION DO YOU AGREE WITH THAT, DO YOU WANT TO MAKE COMMENTS ON IT. THE NEXT IS THE SEXUAL GENDER MINORITIES RESEARCH WORKING GROUP WHICH ALSO DOESN'T MAKE ITS RECOMMENDATIONS DIRECTLY TO NIH BUT THROUGH FACA APPROVED GROUP LIKE YOU. THIS IS A REPORT REVIEW STATUS OF WORKING OR IMPLEMENTING THE STRATEGIC PLAN AND OUT OF THAT CAME RECOMMENDATIONS FOR WHAT THEY THINK THEY NEED TO DO EVEN MORE SUCCESSFUL GOING FORWARD. WHAT WE ASK YOU TO DO IS APPROVE OR DISAPPROVE THE REPORT AND RECOMMENDATIONS, WHICH WILL GO FOURTH. SEPARATELY WE WILL CAPTURE YOUR COMMENTS WHICH WILL BE A COMPANY THAT REPORT TO FRANCIS. YOU ARE WELCOME TO MAKE ANY COMMENT ABOUT IT. YOU ARE ASKING TO VOTE YES OR NO. WHY NO? IF YOU NEAL THERE WASN'T HONEST EFFORT TO INVESTIGATE THE NEEDS IT WAS UNREASONABLE. BUT PRODUCE THEIR HOME WORK AND YOU ACKNOWLEDGE THAT. WE WILL CAPTURE ANY COMMENT YOU MAKE WHERE YOU MIGHT MAKE ADDITIONS OR CORRECTIONS. THOSE WILL GO TO FRANCIS TOO. THIS IS STARTED BY DR. KAREN PARKER DIRECTOR OF OFFICE AND SHE'S GOING TO SPLIT THIS PRESENTATION WITH DR. SCOUT ON THE WORKING GROUP. I WILL SAY THAT DR. MITCHELL IS ALSO IN THE WORKING GROUP. FROM IT IT IS IT IS THAT SPANS THE ENTIRE AGENCY SO OUR OFFICE LEADS IMPLEMENTATION OF THE PLAN, REPORTING ON THE PLAN, AND SERVES AS A BLUEPRINT HOW OUR OFFICE THINKS ABILITY INITIATIVES THAT WE SUPPORT AND INITIATIVES THAT WE WORK ACROSS THE AGENCY, TO PUSH FORWARD. GOAL FOUR OF THE STRATEGIC PLAN IS EVALUATE PROGRESS ADVANCING SGM RESEARCH. TWO UNDER 4 SUGGESTIONS IN 2018 WE CONVENE SGM HEALTH RESEARCH EXPERTS TO REVIEW NIH MID COURSE PROGRESS ON THE STRATEGIC PLAN. THIS IS WHERE THE MID COURSE REVIEW COMES FROM. WHAT WE DID THIS YEAR IS CONVENED THE WORKING GROUP, PROVIDED THEM WITH A LOT OF DATA, THAT SAID THIS IS THE PROGRESS NIH MADE SINCE RELEASE OF REPORT IN 2018, WE'LL DO THAT THROUGH GIVING THEM OUR TWO REPORTS AND OTHER DATA TO DATE AND TWO PUBLISHED PORTFOLIO ANALYSES, THEY WERE ABLE TO SEE ACROSS THE BOARD THE TYPES OF THINGS NIH DOING IN SUPPORT OF OUR PLAN AND THE WORKING GROUP DEVELOPED THE RECOMMENDATIONS IN THIS REPORT YOU WILL FIND IN YOUR NOTEBOOKS TODAY. SO SCOUT WILL GO OVER EACH ONE OF THOSE WITH YOU, THESE ARE THE MEMBERS OF OUR WORKING GROUP. YOU WILL SEE OBVIOUSLY SCOUT AND DR. MITCHELL ARE BOTH WORKING GROUP AND DR. LESLIE WHO IS FORMER MEMBER OF COUNCIL, WAS PASSIONATE ABOUT THIS WORK WHEN SHE GOT INVOLVE AND ASKED TO REMAIN ON THE WORKING GROUP THOUGH COUNSEL TERM EXPIRED. >> EXCELLENT. THANK YOU. I LOVE THE FACT I CAN WALK AROUND. THIS IS THE MOST EXCITING PART OF COUNCIL YEAR FOR ME IS WHEN WE CAN TALK ABOUT THIS OTHER WORK WE ARE DOING HERE. I WANT TO SAY THAT AS SAID WE WANT TO GET COMMENTS FROM YOU. IF WE JUST GET UP OR DOWN WE LOSE OPPORTUNITY TO ADD INPUT OR WEIGHT AS IT GOES FORWARD SO AS WE GO THROUGH THESE FOUR GOALS, I WILL STOP AND ALLOW TIME FOR DISCUSSION ON EACH ONE OF THE FOUR GOALS AND INPUT COMMENTS YOU MAY HAVE. WITH THAT I ALSO WANT TO DO A LITTLE BIT SETTING THE STAGE AS WELL TO GO BACK FURTHER A LOT OF THIS EMERGES OUT OF MEETINGS THAT HAPPENED BACK LATE 2000 TRYING TO URGE NIH TO TAKE ACTION ON THIS SUBJECT AT THAT POINT MINIMAL RESEARCH DONE, MOSTLY AROUND HIV AS A RESULT IN 20 # 1 NIH PUBLISHED THE EXTENSIVE LITERATURE REVIEW ON SEXUAL GENDER MINORITY HEALTH AND OUT OF THAT CAME SEVEN RECOMMENDATIONS, FIRST WE CREATE A FULL RESEARCH AGENDA. SECOND OF ALL THAT WE ENCOURAGE ROUTINE AN CONSISTENT DATA COLLECTION FOR THE POPULATION. LACK OF DATA COLLECTION, REMEMBER THIS. IN PUBLIC HEALTH IF WE DON'T HAVE DATA, DON'T IDENTIFY A PROBLEM AND CAN'T MOVE TO ACT OR TEST INTERVENTIONS SO THE FACT THAT WE HAVE HAD A PERSISTENT LACK OF DATA CORRECTION ACROSS SURVEILLANCE INSTRUMENTS AND RESEARCH STUDIES HAS BEEN A HUGE BARRIER TO BEING ABLE TO WRITE PROPOSALS TO GET FUNDING TO CONTINUE MOVING FORWARD. YOU TEST MEASURES FOR DATA COLLECTION, I SAY WE, NIH, NIH WOULD ENCOURAGE INCLUSION ON ELECTRONIC HEALTH RECORDS, NIH RESEARCH BEST STRATEGIES TO REACH THE HARD TO REACH POPULATION. THAT NIH WOULD PROVIDE COMPREHENSIVE TRAINING PROGRAM FOR RESEARCHERS. THAT LDBT PEOPLE IDENTIFY AND BE INCLUDED IN MAINSTREAM RESEARCH THE WAY TO PHRASE THAT WAS IF YOU DO NOT INCLUDE WOMEN OR CHILDREN IN RESEARCH GRANT YOU SHOULD EXPLAIN WHY. IN THAT SAME WAY, IT WAS POSITED TO CONSIDER SAYING IF YOU'RE NOT GOING TO INCLUDE SGM PEOPLE, EXPLAIN WHY. OTHERWISE INCLUDE THEM. THIS IS YOU HAVE TO COLLECT DATA ON THIS POPULATION IN THE FIRST PLACE. ANOTHER PIECE OF FRAMING, THAT'S THE INSTITUTE MEASUREMENT REPORT. ANOTHER FRAMING I WANT TO GIVE YOU FROM THE POPULATION PERSPECTIVE, BECAUSE IF YOU'RE NOT IN THE POPULATION YOU MAY NOT BE AS FAMILIAR. OVER THE LAST TWO YEARS WE HAVE HAD A CONSISTENT SERIES OF ROLL BACKS RELATED TO SGM HEALTH AND RIGHTS ISSUES IS INCREASINGLY MAKING THE POPULATION CONCERNED AND WARY TO THE POINT HONESTLY WHEN I TOLD OTHER SGM RESEARCHERS THIS PRESENTATION WAS HAPPENING TODAY JUST THE PRESENTATION, NOTHING ABOUT THE CONTENT WHATSOEVER THERE WAS LEVEL DELIGHT I WAS SURPRISED BY BECAUSE AT THIS POINT WE HAVE COME TO NOT EXPECT IT. TO REVIEW THEM BRIEFLY, HHS IS NOW CONSIDERING ROLLING BACK TO DEFINITION OF BIRTH SEX TO BE DEFINITION OF SEX ONLY ASSIGNED AT BIRTH, FOR TRANSGENDER PEOPLE LINE MYSELF IF SOMEONE DISCRIMINATES AGAINST ME WITHIN HHS BASED UPON MY TRANSGENDER STATUS I HAVE NO RECOURSE WHATSOEVER LIKE I DID COUPLE OF YEARS AGO. ALSO THERE'S OBVIOUS THINK BAN ON MILITARY RECRUITS FOR TRANSPEOPLE. ONE THING THAT CAME OUT EARLY TWO YEARS AGO WAS A SEVEN BAN WORDS AT CDC INCLUDING EVIDENCE BASED, INCLUDING DIVERSITY AND TRANSGENDER. TRANSSTUDENTS ARE NO LONGER PROTECTED IN BATHROOMS, IN EDUCATION, SO IF THEY EXPERIENCE DISCRIMINATION IN BATHROOMS THEY HAVE NO RECOURSE WHATSOEVER. THE ATTORNEY GENERAL ANNOUNCED THE 1964 SEVERAL RIGHTS LAW DOES NO LONGER PROSECT TRANS-PEOPLE. HEALTHY PEOPLE 2030 HAS THE NEW DRAFT RECOMMENDATIONS ARE OUT OUT FOR HEALTHY PEOPLE 2030 AND THEY INCLUDE LDP BUT NOT T AS PRIORITY POPULATION. HOPEFULLY WE'LL GET THAT CHANGED BUT YOU GET A SENSE THAT WE NOW HAVE THIS SERIES OF ACTIONS THAT ARE VERY WELL KNOWN TO THE TARGET POPULATION. THAT MAKES US EVEN MORE CONCERNED AND WARY ABOUT ANY ATTENTION MIGHT GET. AT THE SAME TIME TO BE CLEAR USING A WE HAVE REPRESENTATIVES FROM EVERY PART OF HHS WHO ARE IDENTIFIED AS LIAISONS WITH SGM ISSUES AN CONCERNS. TO BE HONEST, THIS WORK GROUP IS ONLY ONE THAT STILL EXISTS NOW. SO ALL OF THOSE HAVE ALSO BEEN ROLLED BACK. SO WITH THAT FRAMING, THAT'S WHERE THE POPULATION OF INTEREST COMES TO OF INTO CONCERN, LET'S TALK ABOUT GOALS AND WHAT THE WORK GROUP SUGGESTED. GOAL ONE RECOMMENDATIONS. PUBLISH FOAs FOCUSED ON TRAINING THE NEXT GENERATION OF SCHOLARS, THROUGH INDIVIDUAL INSTITUTIONAL AWARDS, EMPHASIZE INSTITUTIONAL AWARDS, AS LITERATURE INDICATES COMPASS SHY AND LESS POPPED RESEARCH AREAS, CROSS PROFESSIONAL COLLABORATION TO FACILITATE TRAINING IN RARE DISEASE AND I WOULD SAY THAT ANOTHER BERNARD KINGTON WAS ALSO ONE OF THE PEOPLE WHO EMPHASIZED STRONGLY TO ME THAT BUILDING THIS CAPACITY OF THE INCOMING RESEARCH CADRE WAS GOING TO BE VERY IMPORTANT IN CHANGING THE TUNE AND NATURE OF THE KIND OF RESEARCH ABLE TO BE CONDUCTED BY THE POPULATION. NOTICED FOCUS ON MEASUREMENT USING OUTPUTS FROM SGM RESEARCH OFFICE SPONSOR MEASUREMENT WORKSHOP THAT HAPPENED A YEAR AGO. ONE OF THE NICE THINGS THAT HAS COME OUT OF THAT IS THAT A THAT OFFICE PUBLISHED A WEB PAGE BUT THIS SHOULD BE MOVING IT ON. JUST AS AN IDEA, I AM TALKING WITH STATE BRSS REPRESENTATIVES HOW TO INCLUDE SGM MEASURES ON STATE BRFSs AND I'M REALLY DELIGHTED TO SAY MANY MORE STATES ARE RIGHT NOW 35 AROUND THE COUNTRY INCLUDE IT. THOSE ARE MEASURES UNTESTED AND ONE THING THAT KEEPS GETTING ASKED IS CAN WE GET THOSE MEASURED THE WAY WE DO WHEN WE PUT THEM ON SURVEILLANCE INSTRUMENTS. SO SOMETHING LIKE THIS FOA OFFER AN OPPORTUNITY TO MOVE FORWARD WITH THAT. ENCOURAGE APPLICANTS TO INCLUSION OF POPULATIONS IN CLINICAL RESEARCH AS APPROPRIATE. AND THIS IS ONE OF THE FEW THAT WE HAVE IN THERE THAT GETS TO ORIGINAL GOAL FOR INCLUSION OF ELECTRONIC HEALTH RECORDS, NIH INCLUDED SGM STATUS ON ELECTRONIC HEALTH RECORDS AT THE HOSPITAL HERE. CORRECT? AT THE CLINICAL CENTER. RIGHT. BUT AROUND THE COUNTRY RIGHT NOW THAT'S STILL A LITTLE BIT LEADING EDGE. AND UNFORTUNATELY EVEN THOUGH WE HAVE PLACES LIKE THE AMERICAN SOCIETY OF CLINICAL ONCOLOGISTS, AND MANY OTHER ORGANIZATIONS RECOMMENDED INCLUSION OF SEXUAL GENDER NIGH MORETY STATUS IN ELECTRONIC HEALTH RECORDS, IT IS NOT YET HAPPENING AND NEEDS A PUSH TO HAPPEN. ONE OUTCOME OF THIS, I WORK IN THE CANCER ARENA, WE CAN GET NO EVIDENCE ON IMPACT ON SGM POPULATIONS ABOUT CANCER INCIDENCE BECAUSE WE'RE NOT INCLUDED IN THE REGISTRIES BECAUSE THEY'RE DERIVED FROM THE ELECTRON INC. HEALTH RECORDS SO IT CASCADES DOWN AND AGAIN DATA GAPS WHICH MEANS WE CANNOT MOVE FORWARD. WITH THAT, DISCUSSION. THOUGHT. REACTIONS. GOAL ONE RECOMMENDATIONS. >> INCREDIBLY INTERESTING, I'M A NEW MEMBER, I TRIED TO READ ABOUT THIS WHILE YOU'RE TALKING. YOUR AREA OF PARTICULAR EXPERTISE IS IN CANCER. >> AND TOBACCO. >> ARE THERE THINGS LIKE FOR EXAMPLE NOT SURE MAYBE BECAUSE OF LATER HORMONAL EXPOSURE, THINGS LIKE THAT COULD YOU EDUCATE US? >> THE OTHER HALF OF WHAT CAME OUT OF INSTRUMENT MEASUREMENT REPORT. THERE'S A CLUSTER OF HEALTH DISMARETIES BY THE POPULATION -- DISPARITIES BY THE POPULATION, PREDOMINANT AROUND RISK BEHAVIORS WITH COPING SKILLS WITH DISCRIMINATION. ONE IS THE HIGHEST AND CREATES THE BIGGEST PROBLEM IS TOBACCO USE. WHILE WE HAVE ABSOLUTELY NO EVIDENCE OF INCREASE CANCER INCIDENCE BECAUSE OF NO INCLUSION THE REGISTRY REGISTRY, IT WOULD BE IMPOSSIBLE FOR US NOT TO HAVE MUCH HIGHER CANCER RATES. BUT YOU ALSO SEE INCREASED DRUG USE AND ALCOHOL USE, YOU HAVE INCREASED CANCER RATES AMONG GAY MEN BECAUSE OF TANNING, THINGS LIKE THAT. IF YOU ARE FAMILIAR WITH UNDERSERVED POPULATIONS WHEN YOU EXPERIENCE STIGMA THERE'S A SET OF COPING STILLS OUT OF THAT WHILE WE LIKE TO THINK HEALTH IS BIOLOGICAL WE REALIZE MORE IS SOCIALLY DETERMINED THAN YOU WOULD THINK UPON ANALYSIS SO WE HAVE LOTS OF HEALTH DISPARITIES. SORRY. LET'S GO HERE. >> I WAS LOOKING, THE FLIP SIDE OF THE -- THIS KIND OF INFORMATION OBVIOUSLY WANT THIS INFORMATION OR NEED THIS INFORMATION, IT'S CRITICAL BUT HOW IT CAN BE USED DETRIMENTALLY, PEOPLE GET INFORMATION ON ELECTRONIC HEALTH RECORDS AND THEY CAN USE -- NOT BENEFICIAL. >> RIGHT. HAVE YOU TAUGHT ABOUT THAT >> WE HAVE BEEN THINKING ABOUT THAT SINCE THE QUESTION OF COLLECTING HIV RELATED DATA. IMAGINE THAT WAS AN ENVIRONMENT THAT WAS ACTUALLY MUCH LESS WELCOMING AND YET THERE WAS A STRONGER IMPERATIVE NEED FOR IT FOR PUBLIC HEALTH CONCERNS. I WILL SAY AS WE HAVE MOVED THROUGH MANY YEARS AND TRUST ME, I WAS THERE WHEN THE STATE OF WEST VIRGINIA HANDED OUT THE NAMES OF EVEN WITH HIV IN IT. THEN RAN AROUND TABLE COLLECTING COLLECTIN G THE PAPERS BECAUSE OBVIOUSLY A HUGE DATA BREECH. BUT ALL THOSE YEARS CONCERNS USE AGAINST PEOPLE, THE TRUTH IS WE HAVE GENERALLY MOVED THROUGH THAT WITHOUT MAJOR NEGATIVE INCIDENCE. THAT WEST VIRGINIA MAKE BEING A SMALL EXCEPTION. AND SO WE UNDERSTAND RIGHT NOW THE BENEFIT WILL PROBABLY HAVE TO COME WITH EDUCATION WITH POPULATION, THERE'S INCREASE RISK AND CONCERNS RIGHT NOW, PARTICULARLY IF THIS DESIGNATION OF HHS THERE'S NO RECOURSE ON DISCRIMINATION EXCEPT THAT BY YOUR BIRTH ASSIGNED SEX, BECAUSE TRANSDISCRIMINATION IS VERY COMMON. AND PEOPLE ARE VERY CONCERNED ABOUT THAT. SO WE NEED TO HAVE EDUCATION BUT THAT SAID,, IT CONSISTENTLY IS RECOMMENDATION OF THE LEADERS IN THE FIELD AND THE PROFESSIONAL BODIES TO MOVE FORWARD WITH THE DATA COLLECTION BECAUSE OF PUBLIC HEALTH BENEFIT OUTWEIGHS THE CONCERNS. YES. >> ONE OTHER AREA ESPECIALLY IN THE CANCER ARENA, IS LACK OF PREVENTIVE SERVICES. FOR THIS GROUP OF PATIENTS. IN MANY CASES NOT IDENTIFIED. AND IN OTHER CASE, LACK OF INFORMATION WHAT KIND OF PREVENTIVE RESEARCH WE NEED TO DO, WHAT ARE THE PREVENTIVE HEALTH AND CANCER PREVENTION STRATEGIES THAT SHOULD BE INCORPORATED LOT OF RESEARCH IS NEEDED. >> GREAT POINT ALSO IF YOU THINK IN CANCER CARE THERE AS BEEN A BIG PROBLEM IN BARRIERS TO CARE. AND DOCTORS TREATING THE POPULATION LIVE LESS THAN POSITIVE ASPECT. WE KNOW 80% OF FIRST YEAR MEDICAL SCHOOL STUDENTS SHOW LEVEL OF IMPLICIT BIAS AGAINST THIS POPULATION. THAT'S SADLY OUR NEWEST GROUP OF PEOPLE COMING INTO THE FIELD. AND SO ONE OF THE CHALLENGES YOU SEE, WE KNOW FROM PATIENT CENTERED RESEARCH IT'S NOT ALWAYS WHETHER THESE TWO DOCTORS GIVE THE SAME TESTS, IT'S WHETHER ONE OF THOSE ACTUALLY SEEMS TO GET BETTER RAPPORT, RELATIONSHIP AND POSITIVE INTERACTION WITH YOU, YOUR MEDICAL OUTCOME WILL BE BETTER WITH THAT DOCTOR. SO THE FACT THAT WE HAVE PEOPLE WHO ARE DRIVING HUNDRED MILES AWAY FROM THEIR LOCAL HOSPITAL BECAUSE IT'S CALLED SAINT MARIES AND AS A RESULT THEY FEAR THIS HOSPITAL WILL NOT TREAT THEM EQUITABLY, IT'S NOT ALWAYS THE CASE BUT THERE'S BEEN SUBSTANTIAL BASIS FOR THAT IN THE PAST AND ARE THEN TRYING TO GET THEIR CANCER CARE A HUNDRED MILES FROM THEIR HOUSE AWAY FROM FAMILY, AWAY FROM SOCIAL SUPPORT AND THESE ACTIONS ARE NOT UNCOMMON. WHEN YOU HAVE CANCER YOU ARE SUDDENLY A FREQUENT FLYER IN THE MEDICAL CARE PROGRAM. THAT MEANS EVERY DOCTOR YOU GET ONLY HAVE TO BE HOPEFULLY WELCOMING AND IF YOU'RE IN RURAL YOUR OPTIONS AND CHANCES CERTAINLY GO DOWN SO IT STARTS TO COMPLICATE THIS CONCEPT OF SMALL BARRIERS TO CARE CASCADE AND BECOME LARGE BARRIERS TO CARE. YES. >> AGAIN, THIS MIGHT BE OBVIOUS TO THE WORK GROUP. USE ANY DATA COLLECTED BY THE -- THERE'S ANOTHER PCORI GROUP CALLED PRIDE NET. >> PRIDE NET IS A PRETTY NEW STUDY RIGHT NOW. TO MY KNOWLEDGE I HAVEN'T SEEN THE DATA OUT THERE USEFUL BUT THAT SAID WE HAVE BEEN LOOKING AT RESEARCH THAT'S OUT THERE. ANYTHING THAT'S PUBLISHED A GROUP OF VERY WELL EXPERIENCED PEOPLE WHO ARE VERY FAMILIAR WITH THE ARENA. >> CORRY LIKES TO SEE OUTSIDE PARTNERS SO PRIDE NET MAYBE VERY WELCOMING OF ANY ASKS YOU MIGHT HAVE IN TERMS OF FUTURE PROJECTS OR, THESE PPRNs, PATIENT POWERED RESEARCH NETWORKS ARE ABOUT THE DATA. THEY MAY BE ABLE TO -- YOU MIGHT BE ABLE TO PUT A QUERY IN AND THEY MIGHT BE ABLE TO PULL FROM -- >> WE WILL DULY NOTE THAT. I LOVE BEING DATA EARLY. >> YOU CAN PROBABLY FIND MORE ONLINE THAN I CAN TELL YOU. BUT THE NAME OF THE PVR PRIDE NET. >> CAN I ADDRESS THAT? WE ARE AWARE OF THE FOLKS AT PRIDE NET, ALSO THE FOLKS WHO HAVE RECEIVED THE ENGAGEMENT GRANT THROUGH THE NIH ALL OF US PROGRAMS, THEY HAVE BEEN ADVISING NIH IN TERMS OF THAT PROGRAM. ENGAGEMENT WITH THE LGBT COMMUNITY SO THAT'S BEEN GREAT. IN TERMS OF PROVIDING DATA TO THE WORK GROUP FOR THIS PARTICULAR REVIEW, WE DID NOT PROVIDE THEM LIKE THE SCIENTIFIC DATA BEHIND HEALTH OF THE POPULATION. THE DATA THAT WE PROVIDED THEM WAS REALLY ABOUT WHAT NIH HAS DONE SINCE INITIATION OF OUR STRATEGIC PLAN. SO THIS WAS REALLY TO SAY, THIS IS WHAT NIH HAS DONE OVER THE PAST COUPLE OF YEARS. THESE ARE YOUR SUCCESSES. NECESSARY ARE SOME OF THE AREAS WE THINK MAYBE WE SEE POTENTIAL FOR MORE PROGRESS WITHIN THE NEXT TWO AND A HALF YEARS OF THE STRATEGIC PLAN SO THE DATA WAS MOSTLY, MOST OF THE DATA WAS PUBLIC DATA ON OUR WEBSITE. BUT IT CAME FROM REPORTS ABOUT WHAT NIH HAS BEEN DOING. >> REMEMBER IT'S ALSO A NEW OFFICE. THE SGM OFFICE IS VERY NEW SO ALL NEW. OTHER QUESTIONS OVER HERE? DID I MISS THAT PART OF THE TABLE? NO? >> ONE OF THE THINGS I HOPE TO THINK ABOUT WITH THIS IS INSTEAD OF BEING FOCUSED NECESSARILY ON RARE DISEASES AND THINGS LIKE THAT, TO FOLLOW-UP ON WHAT DR. MITCHELL TALKED ABOUT, THIS WHOLE ISSUE OF PREVENTION AND WHAT I CONSIDER CLINICALLY RELEVANT AND IMMEDIATELY IMPACTFUL RESEARCH. THERE'S SO MUCH WE DON'T KNOW ABOUT THAT WE -- THAT WE NEED TO GET IN THE HANDS OF PRACTITIONERS SOME EVIDENCE BASED DATA. I THINK -- BECAUSE I'M IN AGING, I'M THINKING ABOUT WE KNOW NOTHING ABOUT AGING EFFECTS AS YOU GO THROUGH TIME, WE JUST NOW STARTING TO DEVELOP RESEARCH. I HATE TO SEE FOUR YEARS FOCUS ON SPECIFIC DISEASES AND NOT FOCUS ON THINGS IMMEDIATELY USEFUL FOR THE -- >> OUR CONCERN IS SO MUCH OF THIS IS BURDEN IS STILL HIV. STILL SEEING LITTLE ON ANYTHING OTHER THAN HIV. WE HAVEN'T GONE PAST PAST THAT INTO SUBSETS YET, JUST TRYING TO GET IT OUT OF -- IT'S NOT JUST HI, THAT DOES NOT DEFINE THE HEALTH OF POPULATIONS. >> CAN I ALSO ADDRESS THAT ISSUE? SO JUST TO BE CLEAR ABOUT THAT SPECIFIC PIECE ABOUT RARE DISEASE, I THINK THAT THE -- I KNOW THE REASON THAT WAS PUT IN WAS REALLY THINKING ABOUT THE DSD INTERSECTS COMMUNITIES. SO WE ARE RECOMMENDING INSTITUTIONAL AWARDS BUT FOR FOLKS WHO DO RESEARCH IN DISORDERS SEX DEVELOPMENT INNER SEX MANY CASES ONE PERSON AT A GIVEN INSTITUTION DOING THAT SO IF WE PROMOTED CROSS INSTITUTIONAL COLLABORATION, SOMETIMES WE'LL PUT OUT AN RFA WHERE EVERYBODY HAS TO BE AT THE SAME INSTITUTION. SO THAT WAS REALLY TO GET AT THAT -- THE -- THOUGH COMMUNITY OF RESEARCHERS FOCUSED ON MANY OF THOSE DIFFERENT DSD CONDITIONS THAT ARE CONSIDERED RARE. SO I THINK THE POINT THAT YOU MADE WAS SPOT ON. BUT THE REASON THAT THAT EXTRA SENTENCE WAS ADDED WAS TO MAKE SURE WE WERE DOING THINGS THAT WEREN'T GREAT FOR SGM RESEARCH EXCET FOR THOSE DOING RESEARCH IN DSDs. >> AND WE'LL TALK MORE ABOUT HOW WE CONCERN ABOUT DSD IS BEING ADDRESSED BY THIS WORK GROUP NOW. >> ONE CONDITION TO THAT SEEMS OBVIOUS IS WHAT ABOUT LONG TERM HORMONE THERAPY EXPOSURE AS WELL AS SURGICAL OUTCOMES. THE NATIONAL INSTITUTE OF MINORITY HEALTH AND HEALTH DISPARITIES ISSUED A PROGRAM ANNOUNCEMENT MARCH OF LAST YEAR, SPECIFICALLY ON HEALTH OF TRANSGENDER AN GENDER NON-CONFORMING POPULATIONS. THE TOPICS INCLUDED IMPROVED METHODOLOGY AND MEASUREMENT, DEVELOPMENT OF TRANSGENDER AND GENDER NON-PERFORMING IDENTITIES. IMPROVEMENTS IN DIAGNOSIS AND CLINICAL MANAGEMENT, QUALITY OF LIFE AND MENTAL HEALTH, SO THERE MIGHT BE RICH OPPORTUNITIES TO PARTNER WITH OTHER ICs. AND THAT PROGRAM ANNOUNCEMENT WAS ISSUED MARCH OF LAST YEAR AND IS GOOD UNTIL 2021. >> VERY EXCITED ABOUT THAT. YOU CONSIDER TRANSWOMEN ARE VERY LIKELY TO FREE INJECT SILICONE, THIS IS NOT SILICONE LIKE FOR BREAST IMPLANT, THAT IS ENCAPSULATED. WE ARE TALKING FREE INJECTION SILICONE. WHAT HAPPENS WITH THAT THROUGHOUT YOUR LIFE? IT SHIFTS AND MOVES. WE HAVE ALMOST NO INFORMATION ON THAT WHATSOEVER SO JUST ONE EXAMPLE HOW WE HAVE MAJOR GAPS IN THIS AREA. I WOULD SAIL HOW IT GOES BACK TO INSTITUTIONAL TRAINING. AS AN EXAMPLE AT ONE POINT I WAS ONE OF TWO Ph.D. LEVEL HEALTH RESEARCHERS WHO WERE TRANSIDENTIFY IN THE COUNTRY. LIKE UNIFORM STATUS, IT SHOWS YOU WE NEED TO BUILD THE CADRE OF PEOPLE WITH THE EXPERTISE IN ORDER TO GET THESE ANSWERS AS WELL. YES. >> JUST QUICKLY, ARE THE DATA BEING COLLECTED FOR ALL OF US? >> SO EXCITED ABOUT THAT. >> PART OF THE DEAF GRAPHIC QUESTIONS ARE THAT. >> THAT MIGHT BE VERY, VERY INTERESTING. I WILL MOVE TO GOAL TWO, REMOVING BARRIERS TO CONDUCTING THE RESEARCH. >> I WANT TO SUMMARIZE OR MAKE A STATEMENT AS WE GO SO WE DON'T COMMENT AT THE END AGAIN TOO. >> I THOUGHT YOU WERE TELLING US TO MOVE FASTER. >> I AM, WE HAVE THREE MORE TO GO. I DIDN'T HEAR ANY COMMENTS ABOUT YOUR EMPHASIS COMPLETELY WRONG YOU MISSED SOMETHING YOU NEED TO ADD SOMETHING, VERY HELPFUL COMMENT, BE MINDFUL OF, RETAIN PERSPECTIVE OF, THIS DATA CAN BE MISUSED, REMEMBER THAT AND INCLUDE WHEN YOU THINK ABOUT WHAT WE'RE DOING, CONTACT PRIDE NET. THERE'S A SPECIFIC ONE. I HEARD VERY POSITIVE COMMENTS WE WILL CONVEY TO THE DIRECTOR. I'M SORRY. >> I GUESS I WOULD SUGGEST THEY ARE MISSING SOME THINGS ALONG BOTH THESE PATHWAYS WE HAVE TO FIGURE SOME WAY TO MAKE IT A CROSS NIH INITIATIVE OR SOMETHING THAT NEEDS TO BE SPECIFICALLY TALK ABOUT IN THEIR GOALS. >> WE DO ADDRESS THOSE ISSUES IN SOME LATER SUGGESTIONS. >> I WOULD ALSO EMPHASIZE AGAIN THE NOTION OF UNINTENDED CONSEQUENCES, BECAUSE THAT ALL GOOD THINGS HAVE UNINTENDED CONSEQUENCES IN THE PRIVACY ISSUE AND THE IMPLICATIONS BECOME HUGE. SO HAVING THAT IN MIND AS ALL THESE THINGS MOVE FORWARD. REALLY CRITICAL TO MOVE FORWARD BUT AS YOU POINT OUT, THERE ARE SOCIAL PRESSURES IN THE WRONG DIRECTIO RIGHT NOW THAT ARE BEING SUPPORTED WASHINGTON. IT'S JUST UNFORTUNATE REALITY. >> RECOMMENDATIONS TO REMOVE PAIRIERS NIH FEED TO CLARIFY INCLUSION OF SGM POPULATIONS, MANY, MANY YEAR EFFORT. ONE OTHER DR. KINGTON FORMER INTERIM DIRECTOR HERE THAT IT BECOME -- SGM BECOME LEGAL HEALTH DISPARITY POPULATION. THAT ALLOWS TO BE INCLUDED IN ALL PLACES WHEN YOU SEE OTHER HEALTH DISPARITY POPULATIONS NEXT TO IT. OUR CONCERN AS WORK GROUP IS PEOPLE DIDN'T NOTICE. SINCE WE HAVE A LONG HISTORY OF HAVING CALL PEOPLE AND SAY WOULD YOU BE WELCOMING TO SGM SPECIFIC PROPOSAL AND FOR MANY YEARS HONESTLY THE ANSWER CAN BE NO, THE MORE YOU PUT SOMETHING IN THE ACTUAL FUNDING ANNOUNCEMENT, ANYTHING LIKE THAT, IF IN BLACK AND WHITE IT WILL ENCOURAGE TO WRITE PROPOSALS IN RESPONSE. SO THIS WAS PLEASE PUBLISH THE FACT, RAISE AWARENESS ACROSS RESEARCH COMMUNITY, LE GAL HEALTH DISPARITY POPULATION AND NIH WILL NOT SAY NO, NO, WE DON'T WANT RESEARCH ON THAT, WE ARE STANDING ALONGSIDE ALL THE OTHER GROUPS THAT ARE PRIORITY. SECOND, EXPAND SGM RESEARCH OFFICE TO INCLUDE ONE POSITION PER SCIENTIST WITH PROGRAM OFFICER EXPERTISE AND ONE WITH A COMMUNICATION SPECIALIST. INCREASE AWARENESS OF SGMRO AND SGM RELATED WORK AT NIH THROUGH TARGETED COMMUNICATION INCLUDING SOCIO MEDIA AND WEB PRESENCE, INCREASE BUDGET, PROVIDE FUNDS FOR TRAINING AND MEASUREMENT FOIA -- NOT SORRY, FOA RECOMMENDED UNDER GOAL ONE. KAREN DOESN'T A AMAZING JOB USING MIRRORS TO GET HERSELF ALL AROUND THE COUNTRY AND RESPOND TO LOTS OF PEOPLEN QUIRING PERSONALLY BUT THAT SAID, IT WAS CERTAINLY OUR STRONG FEELING THAT SHE COULD USE MORE SUPPORT AND ESPECIALLY IF THESE FOAs START TO ROLL OUT, WE NEED TO RAISE AWARENESS AND PROFILE OFFICE OVERALL FOR PEOPLE TO KEEP APPRISED OF OPPORTUNITIES AND TO BE ENCOURAGED AS THEY CONTINUE TO COME UP THE RANKS. SO THAT DISCUSSION, COMMENTS, THOUGHTS. >> >> AS PAR FOR THIS OFFER GUNS IN TERMS OF TYPES OF RESEARCH THAT YOU DON'T WANT? I GUESS ONCE YOU HAVE CERTAIN TYPES OF RESEARCH THAT PUT THESE POPULATIONS, IT COULD OPEN THE DOOR FOR GOING IN DIFFERENT DIRECTIONS YOU ARE NOT -- YOU DON'T WANT. >> THERE'S NOT A MECHANISM FOR THINKING ABILITY WHAT YOU DON'T -- I THINK NIH ENCOURAGING WHAT MAYBE WANTED OR GENERAL DIRECTIONS. >> SO WE TYPICALLY PARTICULARLY WITH FOA WE TALK ABOUT MAYBE SOME RESEARCH OPPORTUNITIES OR NEEDS THAT HAVE BEEN IDENTIFIED. BUT REALLY LIKE THE APPLICATIONS THAT COME IN ACROSS THE BOARD RELATED TO SGM, SOME COME THROUGH THE SGM SPECIFIC FOA. LIKE MENTIONED TRANSGENDER FOA BUT OUR OFFICE DOESN'T SEE ALL OF THOSE SO WE ARE REALLY COORDINATING OFFICE, WE DON'T HAVE GRANT MAKING AUTHORITY BUT WORK CLOSELY WITH THE ICs AND THEN THEY THINK ABOUT THEIR INDIVIDUAL MISSIONS VISIONS AND PRIORITIES AND WHERE SGM WORK INTERSECTS. SO THAT'S HOW THOSE TYPES OF DECISIONS ARE MADE. WE LEAVE THE SCIENTIFIC MERITORIOUS QUESTIONS TO -- >> AGAIN SINCE YOU ARE OFFERING DATA GAPS AND TRYING TO GET YOUR PROPOSAL SCORE IN THE FIRST PLACE, IT'S UPHILL BATTLE WHICH MEANS NOT UNDERSTOOD TAKING TO THIS AND COMMITTED TO THE CONCEPT IN THE FIRST PLACE. >> PAUL'S IDEA WORTHYING ABOUT. THE COMMON FUND APPLICATIONS, LIKE INNOVATOR AWARDS, THINGS LIKE THAT, DO SAY WHAT YOU DON'T WANT AND HELPS YOU UNDERSTAND MAYBE MORE WHAT YOU DO WANT. I THINK ABOUT IT, I THINK BECAUSE IT MIGHT HELP. >> PERMISSIBLE WE DO THAT SO PEOPLE AREN'T MISLED. >> FAIR ENOUGH. OTHER COMMENTS SUGGESTIONS. >> >> I WAS GOING MAKE THE SAME POINT, OTHER QUESTION, WITH OTHER INSTITUTES WE HAVE PROPOSALS THAT CAN GET OVER THE HUTCH OF THE FUNDING AVAILABILITY. HAS THAT BEEN TALKED ABOUT AT COMMITTEE LEVEL? >> OUR OFFICE HAS A CO-FUND PROGRAM SO OVER THE PAST THREE YEARS WE FUNDED ADMINISTRATIVE SUPPLEMENTS IN SGM HEALTH RESEARCH AND TYPICALLY THOSE ARE CO-FUNDED WITH ICs AND OFTEN TIMES WITH THE OTHER DIVISION OFFICES. ODP AND OPSR, AT THIS POINT WE CO-FUND THINGS LIKE WORKSHOPS, NIMHD, SUMMER RESEARCH INSTITUTE, THOSE KINDS OF THINGS. WE DON'T -- OUR BUDGET IS SUCH THAT WE HAVEN'T BEEN ABLE TO CO-FUND LARGE RO1s OR THOSE TYPES OF THINGS SO I WOULD IMAGINE SOMETIMES IN THE FUTURE WE MOVE MORE IN THAT DIRECTION MENT -- >> I'M HEARING HELPFUL COMMENTS FOR US TO CONVEY. BUT THAT'S IT. >> SORRY. >> JUST THINKING ABOUT YOUR COMMENT ON CANCER, THINKING NAVIGATORS DEVELOPED IN CERTAIN CANCER CENTERS. IN TERMS OF REMOVING BARRIERS, NAVIGATOR TRAINING TO HELP RESEARCHERS IN THOSE POPULATIONS OR THAT KIND OF CONCEPT? >> RIGHT NOW WE ARE STRUGGLING WITH LACK OF TRAINING ACROSS ALL THE MEDICAL PROFESSIONS. IN ADDRESSING ISSUES RELATED TO THIS POPULATION. AS A MATTER OF FACT LAST WEEK RESEARCH JUST CAME OUT OF A SAMPLE OF ONCOLOGISTS SHOWING THAT OVER HALF OF THEM DID NOT THINK THEY HAD ADEQUATE KNOWLEDGE TO TREAT THE LGB POPULATION AND IT WAS EVEN HIGHER FOR THE T POPULATION. SO THIS SHOWS A HUGE OPPORTUNITY AND THAT'S THE ONCOLOGY LEVEL, ONCOLOGIST LEVEL ONCE DOWN TO THE ALLIED HEALTH PROFESSION, THE PROBLEM I'M SURE CONTINUES. SO THERE'S ONLY OPPORTUNITIES. PUT IT THIS WAY, ONLY CHALLENGES BUT ONLY OPPORTUNITIES IN THAT AREA AND WE CAN GET A BIG WIN WITH ABLE TO ADDRESS IT. WE ARE THINKING ABOUT TRYING TO FIGURE OUT IF TRAININGS ARE ONLINE IT DOESN'T TAKE A HUGE INITIATIVE TO START TRAININGS AND SAY YOU HAVE THE OPPORTUNITY. GO ACCESS IT. >> SO WE'LL GO TO THREE. T CHARLES BROUGHT UP SOMETHING, WRITES UP THE STRATEGY WE USE FROM OUR DIVISION, WE'RE NOT AN INSTITUTE, WE DON'T HAVE LARGE BUDGETS IN OUR OFFICES SO OUR GOAL TO UNDERSTAND HOW TO GET ALL OF NIH TO DO WHAT WE THINK IS THE RIGHT THING. SO WHAT IS THE STRATEGY,? >> COMMUNITY RESEARCHERS AND SCHOLARS WHO CONDUCT THIS RESEARCH. WORK IN THE NATIONAL SCIENCE FOUNDATION, WROTE THIS GOAL AND DIDN'T REALIZE THE NATIONAL SCIENCE FOUNDATION WAS GOING TO COME OUT AND MAKE A DECISION TO INCLUDE SEXUAL AND GENDER MINORITY DATA IN THEIR GRADUATE STUDENTS AND POST-DOC RATES DATA COLLECTION PROGRAM, THAT WAS A BIG CHANGE, THEY JUST ANNOUNCED VERY RECENTLY. BE LOVELY NIH CONSIDER A SIMILAR CHANGE TOO. SO TO WORK WITH THEM AROUND THEIR EFFORTS CHANGING THAT SO WE HAVE SOME SENSE OF WHO THE INCOMING INSTITUTIONS ARE. WHO THE INCOMING RESEARCHERS ARE, JUST TO TELL YOU, ALL THE DATA WE NOW HAVE ON SGM RESEARCH AT NIH IS BECAUSE WE'RE ANALYZING ABSTRACTS NOT BECAUSE WE HAVE ANY KNOWLEDGE RELATED TO THE PARTICIPANTS IDENTITY OR RESEARCHERS IDENTITY. IT'S SIMPLY FROM ANALYZING ABSTRACTS. SO THAT AGAIN IS A HUGE OPPORTUNITY FOR GROWTH. THEN WE ARE VERY CONCERNED THE HGBT AND INTERSECTS OR DISORDERS OF POPULATION DO NOT AS CLOSE AWAY AS WE MIGHT HOPE AND THE WORK OF THIS OFFICE, IS NOTED CATTILY ELEVATING DSD CONCERNS AND ISSUES. AND PART OF THAT IS COMPLICATED BY THE FACT DSD RESEARCH COMMUNITY IS AS WAS SAID EXTREMELY FRACTURED OFTEN ISOLATED. NOT AS MUCH AD HEARINGS OR UNIFIED DECISION MAKING GOALS AND PRIORITIES SO WE TALK ABOUT HOW TO ADDRESS THAT, FIX THAT, AND WORKSHOP COULD BE CREATED, SPECIFICALLY FOCUS ON THE ISSUES BRINGING TOGETHER LEADING RESEARCHERS AND TRYING TO GET A SENSE OF TOP PRIORITIES AND ISSUES TO WORK ON WE DEFINITELY BE BENEFITED AS A RESULT. ALSO WE HAVE THIS LARGE -- WE HAVE THIS ACTIVE OFFICE OF SCIENTIFIC WORK FORCETY VERSETY WITH INITIATIVE TO TRY AND REDRESS DISCRIMINATION AGAINST SOME POPULATIONS IN THE RESEARCHER WORLD. RIGHT NOW WHILE AMENABLE AND SUPPORTIVE,S OF SGM RESEARCHERS IT'S NOT INCLUDED IN THE WORK HAPPENING WITH THE OFFICE. SO ANOTHER THING WE THOUGHT WOULD BE GREAT MOVE, FORMALLY INCLUDED IN WORK IN THAT OFFICE AND THAT OFFICES PROGRAMS. THOUGHTS, COMMENTS, SUGGESTIONS. >> THIS IS PROBABLY COMING OUT WITHOUT MY HAVING FULLY THOUGHT THROUGH SO FORGIVE ME IF IT SOUNDS WEIRD HERE BUT YOUR SECOND RECOMMENDATION TO CONDUCT WORKSHOPS SPECIFICALLY FOCUSED ON RESEARCH, I AM HEARING IN THIS AREA YOU HAVE ORGANIZATIONS THAT ARE NOT NECESSARILY TEALING WITH ONE ANOTHER. THAT RAISES A REGULAR FLAG BECAUSE MY WORK, WORKING WITH RULE YOU FIND OUT THESE SEGMENTATION OR THE SEGREGATION IS THERE FOR A REASON. AND PEOPLE DON'T DO WELCOMING TOGETHER AND SO A WORKSHOP DOESN'T SOUND LIKE ENOUGH AND WONDERING WHETHER OR NOT YOU NEED TO HAVE ONGOING WORK TO PULL THOSE PIECES TOGETHER IN SOME WAY. THAT WAS THE FIRST GUT REACTION I HAD. >> >> EXCELLENT SUGGESTION. I'M NOT SURE IF THIS IS BECAUSE PEOPLE DON'T WORK WELL NECESSARILY BUT MAY NOT HAVE BEEN GIVEN OPPORTUNITIES TO COLLABORATE AND INTERACT. MAY NOT HAVE GIVEN A FORM TO GET TOGETHER CONFERENCES THINGS LIKE THAT LIKE OTHER ARENAS HAVE. SO IT COULD BE A GROWTH ISSUE IN IN THE ARENA RIGHT NOW. >> MAKE A COMMENT ABOUT THAT. THAT IS A GREAT POINT. THIS IS THE RECOMMENDATION THE WAY THAT CAME ABOUT WAS UNDER GOAL 3 OUR OFFICE HAS BEEN WORKING ON REGIONAL WORKSHOPS. WE COLLABORATED WITH THE FENWAY INSTITUTE IN BOSTON IN MAY, COLLABORATING WITH UCLA NEXT MONTH. WE ARE HOLDING BASICALLY SGM REGIONAL WORK SHOTS WHERE MYSELF AND SOME PROGRAM OFFICER HEAD OUT THERE, WE INVITE ESTABLISHED RESEARCHERS SUCCESSFUL IN OBTAINING NIH FUND AND WE INVITE STUDENTS POST-DOCS AND EARLY INVESTIGATORS TO COME AND DO A GRANTS WORKSHOP, ROUND TABLE DISCUSSION AND PROVIDE LOTS OF NETWORKING OPPORTUNITIES. WHAT WAS DISCUSSED AT THE WORKING GROUP WAS THAT THE DSD RESEARCH COMMUNITY NEEDED A REGIONAL WORKSHOP THAT WAS FOCUSED SPECIFICALLY ON THEM TO CONNECT TO WET NETWORKS AND LEARN MODER ABOUT NIH. WHAT WE TALKED ABOUT WE CALLED A REGIONAL WORKSHOP BUT THEN WE WERE LIKE HOPEFULLY DO A COUPLE MORE NATIONAL TO MAKE THE NETWORKS HAPPEN. THIS IS NOT A STATE OF THE SCIENCE WORKSHOP, NIH HAD ONE A COUPLE OF YEARS AGO ON DSD, EVENTUALLY WE'LL DO ANOTHER ONE BUT THIS IS TO TARGET THE DSD RESEARCH COMMUNITY IN TERMS OF THE GRANTS PERSONSHIP AND MENTORING AND NETWORK. NETWORKING. THAT COMMUNITY OF RESEARCHERS MAYBE -- MAY NEED DIFFERENT THINGS THAN COMMUNITY OF RESEARCHERS DOING OTHER SGM RELATED WORK. NOT SURE IF THAT HELPS. >> WHAT I'M HEARING WHAT YOU ARE SAYING, WORKSHOP IS GOING TO PROMOTE MORE NETWORKING ON REGIONAL BASIS TO ALLOW NOT ONLY WORK TOGETHER BUT WORK WITH YOU HOW TO UNDERSTAND IN SOME WAY. >> >> OUR LAST ONE, EVALUATING PROGRESS AND ADVANCING SGM RESEARCH, MOST EFFECTIVE WAY TO COLLECT AND REPORTEN A SGM STATUS IN CLINICAL RESEARCH FUNDED BY NIH. AGAIN, THIS GETS TO CONCEPT OF INCLUDING IN HEALTH RECORDS AND IF THERE'S GREATER PRECEDENT WITHIN NIH HOW TO DO THAT I -- THERE WILL BE A LOT OF WATER FALL EFFECT WITH A LOT OF OTHER HEALTH PROGRAMS AS WELL. PROVIDING MORE EXHAUSTIVE PORTFOLIO ANALYSIS BY SGM POPULATION AND RIGHT NOW REMEMBER WE'RE NOT COLLECTING SGM POPULATION DATA SO WE FIRST NEED TO COLLECT IDENTITY DATA IN ORDER TO UNDERSTAND THE PORTFOLIO ANALYSIS. NIH FUNDED SGM RESEARCH, IDENTIFY CARE SON GROUPS FOR CONDUCTING AIL ANALYSES. IT WAS ARE WE LOOK FORWARD TO THE DAY WE CAN MOVE BEYOND THE IDEA OF IDENTIFYING SGM RESEARCH BY ABSTRACTS ONLY, INSTEAD TALKING ABOUT IDENTITY OF RESEARCHERS AND IDENTITY OF PARTICIPANT WILL GIVE A MUCH FINER TOOL WHICH TO UNDERSTAND HEALTH DISPARITIES AS POPULATION AND MOVE ON THEM. INCLUDING THE NEXT SGM RESEARCH STRATEGIC PLAN GOALS RELATED OPERATIONAL ACTIVITIES AND SCIENTIFIC OPPORTUNITIES WITHIN FIELD WE HAVEN'T BEEN -- WE HAVE BEEN DOING WORKING ON WHAT MIGHT BE THE BASIC STEPS IN THIS FIRST STRATEGIC PLAN NIH CAN TAKE IN ORDER TO MOVE FORWARD THE FIELD. AS WE THINK ABOUT THE NEXT STEPS IN THE STRATEGIC PLAN WE CAN GO BEYOND BUILDING BLOCKS AND THINK ABOUT IDENTIFYING SCIENTIFIC OPPORTUNITIES SPECIFICALLY TO PEOPLE GET INTO. FOR EXAMPLE WE DON'T HAVE RESEARCH BEING DONE FROM NCI. LARGE PART OF NIH. THERE ARE PLACES LIKE THAT, THIS MIGHT BE AN OPPORTUNITY TO HELP THE FIELD, ADVANCE THE FIELD AND WORK WELL WITH EXISTING RESOURCES. YES. >> THIS IS REALLY IMPORTANT AND INTERESTING. ONE SUGGESTION WOULD BE TO EITHER FOR EACH GOAL OR MAYBE COLLECTIVELY TO HAVE SPECIFIC METRICS THAT WILL TELL YOU YOU MOVE FORWARD AND THERE'S SUCCESS THE GOALS ARE GLOBAL BUT MAYBE IF THERE ARE SPECIFIC THINGS FOR EXAMPLE HOW MANY GRANTS, HOW MUCH, WHAT IS IT YOU, IF YOU LOOK BACK YOU SAY WE ACTUALLY ACCOMPLISHED, WHAT IT WAS THAT WE WERE AFTER, HARD TO ARTICULATE. SO CAN'T BE MORE SPECIFIC THAN THAT. WHAT SEEMS MISSING IN MY MIND IS SOMETHING CONCRETE. THAT YOU CAN SAY THIS IS WHAT WE ARE TRYING TO ACHIEVE. LOOKING BACK WE GOT THERE, THIS IS WHERE WE MISSED THE MARK. >> EXCELLENT SUGGESTION. COMMENTS SUGGESTION, GOAL, CONSOLATION FOR ALL IN GENERAL? >> IS THERE AGREED UPON COMMON DATA ELEMENT NOW FOR -- >> I WILL SAY WHAT WE ARE GETTING NOW IS BRFSS RECOMMENDED DATA ELEMENTS CURRENTLY THE WHITEST AND MOST COMMONLY USED IN SURVEYS. WHICH MAKES IT MORE CONCERN THEY'RE NOT REALLY WELL TESTED BUT YOU GOT AN N OF 400,000 ACROSS BEHAVIORAL RISK FACTOR SOCIAL SURVEY ACROSS THE COUNTRY, 35 STATES USING THESE RECOMMENDED DATA ELEMENTS. WE ARE RAPIDLY GETTING A STANDARD. IS IT NECESSARILY A SCIENTIFIC STANDARD WE WANT. THAT'S PROBABLY STILL ANOTHER POINT. >> DO YOU SEE A POINT WHERE NIH STUDIES THAT ASK THE QUESTION IN OUR REGISTRY WE SAY MALE OR FEMALE. GENDER, SEX. IS THERE A GOAL TO HAVE STANDARDIZATION AROUND THIS OR IS IT -- >> YES. ABSOLUTELY. >> AN ATTAINABLE GOAL? >> I THINK IT'S ALSO ATTAINABLE GOAL. VERY LITTLE EFFORT RESEARCHING MEASUREMENT ISSUES SO FAR. SO ONE THINGS IF THERE IS MORE RESEARCH IN MEASUREMENT ISSUES WE ARE GETTING CLOSER TO THAT GOAL. IT'S VERY COMMON PEOPLE ARE CONSIDERING THE TWO STEP QUESTION FOR GENDER IDENTITY. WHAT IS BIRTH AND CURRENT GENDER BE WORKED SUCCESSFULLY ACROSS A LOT OF DIFFERENT PLACES. THERE'S PRECEDENT LIKE THAT, THERE HAS BEEN STUDIED AND IS RAPIDLY MOVING FORWARD. SO THIS QUESTION IS ADD MORE RESORTSES TO THIS AND GET US TO THAT POINT OF A COMMON DATA ELEMENT. >> I WILL LOOK AROUND THE ROOM AND MAKE THE STATEMENT. >> JUST TO ADD TO THE SUMMARY, THIS IS A VERY IMPORTANT AREA OF CLINICAL MEDICINE. WHERE WE KNOW LITTLE WHERE THERE ARE NO GUIDELINES OR PRACTICES THAT ARE UNIVERSAL AND CONSEQUENTLY RESEARCH. HOW DO WE BRING GROUPS TOGETHER THAT ARE CONDUCTING RESEARCH. SO THERE IS GREATER BENEFIT. IT IS VERY OBVIOUS THIS IS AN AREA WHERE PREVENTION IS NEEDED, MORE EDUCATION IS NEEDED. BASIC INFORMATION. SO THAT THE RESEARCH THAT NEEDS TO BE DONE IN THE LGBTQ COMMUNITY, WILL HAVE TREMENDOUS POTENTIAL IMPACT. THROUGHOUT THE COUNTRY, NOT ONLY FOR THE PATIENTS, BUT FOR THE PROVIDERS AND RESEARCHERS ON HOW TO CONDUCT RESEARCH. WHAT VERBIAGE IS EVERYONE ACCEPTABLE OR MEANINGFUL. WE NEED RESEARCH THROUGHOUT THE CLINICAL COMMUNITY, RESEARCH COMMUNITY, FROM PATIENTS WITH PATIENTS AND OTHERS. SO I THINK IT'S A START. BUT THERE IS A LOT TO BE DONE. THANK YOU. >> >> I WANT TO THANK YOU EDITH AND MEANT OF THE WORK GROUP PUT IN A LOT OF TIME THINKING ABOUT THAT AND A LOT OF THEIR OWN EFFORT. >> >> CHARLES. NOTICED YOUR HAND. >> NO. >> SO THE WAY WE'LL TO THIS IS I'M GOING TO LOOK AROUND THE ROOM, LOOK FOR HEAD NODS AND SAY THAT I HEARD NO ONE NO STATEMENTS THAT WOULD LEAD YOU TO REJECT THE REPORT AND RECOMMENDATIONS BUT CERTAINLY MANY VERY HELPFUL POSITIVE COMMENTS TO ADD TO CONVEY TO THE DIRECTOR, INCLUDING WE'LL START WE DEATH PERSPECTIVE. WHAT -- EDITH PERSPECTIVE. CAN I HEAR A MOTION TO ACCEPT THE REPORT AND RECOMMENDATIONS? SECOND? ALL IN FAVOR. OPPOSED. DISCUSSION. VERY GOOD. THANK YOU. THANK YOU VERY MUCH. SO WE WILL MOVE TO OUR THIRD PRESENTATION. THIS IS FROM DAVID MURRAY WHO DIRECTS OFFICE OF DISEASE PREVENTION, HE WILL BRING YOU UP TO DATE DEEP DIVE HUMAN PRIMARY DISEASE PREVENTION PORTFOLIO LEADS TO MAKE SUGGESTIONS TO THE INSTITUTE DIRECTORS ABOUT HOW TO APPROACH DISEASE PREVENTION RESEARCH. SO LOOKING FOR INPUT FROM YOU. >> CAN YOU HEAR ME? I'M DAVID MURRAY ASSOCIATE DIRECTOR FOR PREVENTION AND OFFICE OF DISEASE PREVENTION WHO WILL TALK TO YOU ABOUT WORK THAT WE HAVE DONE IN THE OFFICE TO LOOK AT THE PORTFOLIO PREVENTION RESEARCH NIH SUPPORTS. I WANT TO START BY POINTING OUT SHERRI SHULLY IN THE BACK ROW HERE. SHE HAS OUR PORTFOLIO ANALYSIS TEAM, NONE OF THIS WOULD HAVE BEEN DONE WITHOUT SHERRI AND TEAM. IS ASHLEY HERE? ASHLEY IS NEXT TO HER. SORRY. CAN'T SEE THAT FAR. SHE IS A MEMBER OF A TEAM, WE HAD A GROUP OF FOUR TO FIVE PEOPLE OVER SEVERAL YEARS WORKING ON THIS. THESE TWO ARE CONTINUING TO WORK ON IT. ODP IS LOCATED IN OFFICE OF -- IN THE DIVISION OF PROGRAM COORDINATION PLANNING STRATEGIC INITIATIVES. AS ALL THE GROUPS YOU HAVE BEEN HEARING ABOUT TODAY. WE ARE PERHAPS LESS WELL KNOWN THAN OBSSR, O AR ORWH BUT WE ARE TRYING. OUR CHARGE IS IMPROVE PUBLIC HEALTH IMPROVING INCREASING THE SCOPE QUALITY DISSEMINATION IMPACT RESEARCH SO WE WORK ACROSS THE ICs AND WITH THEM. WE WON'T GET FAR WORKING ON OUR OWN. WE RELEASED OUR NEW STRATEGIC PLAN IN OCTOBER. WE HAVE COMPLETED THE FIRST FIVE YEAR PLAN, THIS IS OUR SECOND. WE HAVE SIX PRIORITIES IN OUR SECOND PLAN. I WILL FOCUS ON THE FIRST ONE IN THIS SET. CONDUCT PORTFOLIO ANALYSIS AND IMPACT ASSESSMENT BUT WE HAVE SIX ALL TOGETHER. WE ARE INTERESTED IN MONITORING NIH INVESTMENTS AND PREVENTION RESEARCH AND PARTICULARLY IN ASSESSING THE PROGRESS AND RESULTS OF THAT INVESTMENT. WE DEFINE PREVENTION RESEARCH TO INCLUDE PRIMARY AND SECONDARY PREVENTION RESEARCH IN HUMANS. ALONG WITH RELEVANT METHODS RESEARCH OR METHOD STUDIES. WE INCLUDE RESEARCH DESIGNED TO PROMOTE HEALTH, PREVENT ONSET OF DISEASE DISORDERS CONDITIONS OR INJURIES AND DETECT AND PREVENT PROGRESSION OF ASYMPTOMATIC DISEASE. THERE'S A LIST OF THINGS COVER #-D IN OUR DEFINITION THAT'S SHOWN HERE. WHEN I WAS INTERVIEWING FOR THIS POSITION I ASSUMED THAT I COULD COME TO OFFICE AND MY STAFF WOULD BE ABLE TO TELL ME HOW MUCH MONEY WAS SPENDING IN VARIETY OF PREVENTION TOPICAL CATEGORIES SUBJECT MATTER CATEGORIES BASED ON STUDY DESIGN USED ON POPULATION BEING STUDIED. BECAUSE I ASSUMED THAT NIH KNEW HOW TO COUNT. AS EPIDEMIOLOGIST THAT'S FUNDAMENTAL THING WE'RE TRYING TO DO AND CERTAIN ARE ASSUME THAT'S POSSIBLE HERE. I GOT HERE AND STARTED LEARNING ABOUT THE RCDC SYSTEM WHICH IS USED AT NIH FOR PORTFOLIO ANALYSIS. AND ONLY WAS HAD TO DISCOVER IT COULDN'T GIVE ME THE DATA I WANTED. IT PROVIDES LOTS OF USEFUL DATA USEFUL TO MANY PEOPLE FOR MANY PURPOSES BUT IT WASN'T WHAT I WANTED FOR OEP. I DIDN'T KNOW WHAT SENSE TVTY AND SPECIFICITY WAS FOR PREVENTION RESEARCH, IT DIDN'T MEASURE THE CONTENT TOPICS THAT I WAS PARTICULARLY INTERESTED IN. IT WASN'T GOING TO WORK. I APPROACHED COLLEAGUES IN PORTFOLIO OFFICE, THAT SAID SHOULD WE TRY TO DO SOMETHING TO CHANGE RCDC TO DO WHAT WE NEED, BETTER TO START FROM SCRATCH. THAT'S WHAT WE DID. WE STARTED IDENTIFYING ACTIVITY CODES THAT SUPPORT PREVENTION RESEARCH ACROSS INSTITUTES AND CENTERS. WE EXCLUDED A VARIETY OF CATEGORIES, WE DECIDED EARLY THAT WE WEREN'T GOING TO INCLUDE WAY SICK OR PRE-CLINICAL, WE EXCLUDED FOR INFRASTRUCTURE FOR TRAINING. WE CONSIDERED BUT DECIDE TO EXCLUDE INTRAMURAL RESEARCH TO FOCUS ON EXTRAMURAL. WE TOOK A CRACK AT CONTRACTS BUT THEY PROVED IMPOSSIBLE TO CODE IN THE SYSTEM MATY WAY USING METHODS, SO WE DO BAN THAT. YIELDS PRODUCTS APPLICABLE TO PREVENTION RESEARCH WITHOUT ADDITIONAL DEVELOPMENT. WE FOCUSED ON R P, U ACTIVITY CODES IN PARTICULAR THOSE THAT HAD AT LEAST 500 AWARDS ACROSS FY 12 TO 17 OR 500 MILLION IN AWARDS, COULD BE EITHER OR. SEVERAL ACTIVITY CODES INCLUDE AWARDS WITH MULTIPLE SUBPROJECTS, COMMON IN THE U AND P AND WE SAMPLED APPLICATION IDs TO AVOID DOUBLE COUNTING. THESE ARE THE 12 CODES WE EXAMINED. IN DETAIL: MOST ARE FAMILIAR WITH THOSE. THE TWO IN BOLD BOTTOM TWO COLUMNS DIDN'T MEET THE THRESHOLD FOR THAT SECTION BUT MET THE THRESHOLD FOR THE OTHER. SO UN 1s DIDN'T HAVE ENOUGH AWARDS TO QUALIFY BUT PLENTY OF DOLLARS. RO 3s DIDN'T HAVE ENOUGH BUT PLENTY OF AWARDS. EITHER OR AND WE KEPT BOTH. HOW DID THE 12 CODES WE PICKED REPRESENT RESEARCH AT NIH AND PARTICULARLY PREVENTION RESEARCH? FY 12 TO 17, THERE WERE 111,000 MADE. WHEN WE LOOK AT R P U WHERE ALL RESEARCH GOES ON, THE NUMBERS ARE APPRECIABLY SMALLER. WHEN WE EXCLUDE THE RPNU ACTIVITY CODES NOT FOCUSED ON RESEARCH WE GET NUMBERS THAT ARE SMALLER. WHEN YOU LOOK AT 12 PICKED THEY REPRESENT 91.7% RESEARCH ACTIVITY CODES AND RP AND U CATEGORIES AND 84.1% OF THE DOLLARS. SO WE DID WELL WITH 12 WE CHOSE. WHICH LOOK AT TYPE 1, 2, 9 AWARDS ACTIVITY CODES BECAUSE THOSE ARE NEW ONES. MACHINE LEARNING TO IDENTIFY PROJECTS FOR CODING. WE ARE INTERESTED IN CODING FOR PREVENTION AWARDS TO TRY TO DEVELOP MACHINE LEARNING ALGORITHMS THAT IDENTIFY OR DISTINGUISH BETWEEN PREVENTION AN NON-PREVENTION AWARDS. WE USED ALGORITHMS I AM NOT EXPERT ON MACHINE LEARNING, GEORGE IS NOTTER HERE SO I CAN'T PUT HIM ON THE MICROPHONE, IF YOU HAVE DETAILS I'LL TURN TO DR. SHELLEY. WE USED A VARIETY OF ALGORITHMS, WE TRAINED THEM WITH THE PRIOR YEARS' DATA AND TURNED IT LOOSE ON THE NEW YEAR'S DATA AND PREDICTED WHICH AWARDS FOR INCLUSION AND WHICH WEREN'T. WE THEN SELECTED FROM THOSE TWO BUCKETS AWARDS WE WERE GOING TO CODE. AWARDS AS PREVENTION WE CODED IN HALF. WE PICKED HALF AT RANDOM TO CODE. THE EXCEPTION WAS RO1 WHERE WE CODED ALL BECAUSE THEY WERE THAT IS SUCH AN IMPORTANT CATEGORY. THEN WE CHOSE 5% OF THE AWARDS THAT IDENTIFIED NOT LIKELY PREVENTION AND CODED THOSE AS WELL. WE WEREN'T CERTAIN WHAT THE SENSITIVITY SPECIFICITY OF THE ALGORITHM WAS GOING TO BE AND DIDN'T WANT TO CODE POSITIVES. WE CODED BASED ON TAXONOMY WE DEVELOPED IN THE OFFICE. WE EXAMINED THE RATIONALE USED FOR THE PROJECT. WE EXAMINED THE EXPOSURE. WE EXAMINED OUTCOMES. WE CODED POPULATION FOCUS, WE CODED STUDY DESIGN, WE CODED PREVENTION RESEARCH CATEGORY. WE HAD 129 TOPICS. AND DEVELOPED 29 PAGE PROTOCOL TO TRAIN OUR STAFF TO DO THIS. WE APPLIED THIS TO TITLE OF ABSTRACT AND PUBLIC HEALTH SIGNIFICANCE. WE HAD INPUT FROM THE PREVENTION RESEARCH COORDINATING COMMITTEE AS WE'RE DOING THIS, WHO. -- THIS WORK. WE USED A TEAM BASED CODING APPROACH, WE HIRED A BUNCH OF NPH GRANTS LED BY Ph.D. EPIDEMIOLOGIST. THEY HAD MPH ENVIRONMENTAL HEALTH, EPIDEMIOLOGY VITAL STATISTICS AND BEHAVIOR HEALTH EDUCATION, VARIETY OF AREAS. WE TRAINED THEM IN GROUPS OF THREE OR FOUR. TRAINING TOOK MONTHS AND WHEN DOING THE WORK THEY WERE OVER SEEN BY OUR STAFF AND BY DR. SHELLEY AND HER TEAM. PEOPLE CODED IN TEAMS OF THREE WORKING FROM ISPCTN PAD, SITTING AT A CONFERENCE TABLE, THEY PULL UP THE ABSTRACT, READ IT TOGETHER BUT INDIVIDUALLY. AND THEN THEY CODED EACH PROJECT WITHOUT TALKING TO EACH OTHER. AFTER BEING DONE THEY STARTED DISCUSSING THE AWARD SEE WHAT ETCH PERSON ASSIGN AND RESOLVE THROUGH DISCUSSION. WE TAUGHT THEM ADVOCATES FROM THEIR PERSPECTIVE. WE ALSO TAUGHT THEM TO ARGUE WITH US BECAUSE WE CAME AROUND BEHIND THEM CODING 10, 20% ABSTRACTS THEY CODED OR AWARDS THEY CODED. AND COMPARING OUR RESULTS AGAINST THEIRS. AND WE WOULD MEET WITH THEM AND RESOLVE DISCREPANCIES. SOMETIMES WE CHANGE OUR MIND MORE OFTEN THEY CHANGED THEIR MIND. AGREEMENT BETWEEN OUR TEAM AND CODERS WAS CAP OF .86 OVER YEAR PLUS WE WERE DOING THIS WORK. WE THEN HAD TO WAIT THE DATA -- WEIGHT THE DATA. WE SAMPLED. SO RO1 CODE ALL OF THEM, WEIGHT WAS ONE. MECHANISMS CODING 50% POSITIVES, THOSE WERE WEIGHTED WITH APPROXIMATELY 2. WHERE WE ONLY SAMPLE FIVE PERCENT NEGATIVE WEIGHT WAS 20. WE USE EXACT NUMBERS BASED ON SAMPLING FRACTION. HOW DID WE DO FROM IN THIS FIRST GENERATION? THIS WAS THE FIRST GENERATION MACHINE LEARNING ALGORITHMS FY 12 TO 17. SINCETIVETY AND -- SENSITIVITY AND SPECIFICITY FOR RCDC WAS UNCERTAIN. WE FOUND THAT APPLIED TO RO1 SENSITIVITY WAS 75.6% MACHINE LEARNING ALGORITHM SPECIFICITY HIGHER. ACROSS THE ACTIVITY CODES WE WERE INTERESTED IN, A BIT LOWER. I WAS NOT SATISFIED WITH THE SENSITIVITY IN MID 60s O OR LOW 70s. I WAS HAPPY WITH SPECIFICITY IN LOW 90s BUT KNEW WE COULD DO BETTER AND CAN'T SHOW YOU DATA FROM THE NEW ALGORITHM BUT I CAN TELL YOU THE SECOND STAGE OR SECOND GENERATION ALGORITHM HAS SENSITIVITY, THESE NUMBERS UPDATED SINCE I MADE THE SLIDE. 96.1 PERCENT SENSITIVITY, 93.6% SPECIFICITY. WITH NEW GENERATION OF ALGORITHM WE'LL FIND VIRTUALLY ALL OF THE PREVENTION AWARDS AND NOT WASTE TOO MUCH TIME CHASING DOWN FALSE POSITIVES AND FALSE NEGATIVES. RESULTS. PRETTY STABLE OVER TIME, THIS IS THE PROPORTION OF ESTIMATED PROPORTION OF NIH PREVENTION PORTFOLIO THAT WAS FOCUSED ON PREVENTION RESEARCH IN HUMANS. DEFINED PRIMARY AND SECONDARY INTERVENTION. 16.9% AVERAGE, IT VARIED FROM YEAR-TO-YEAR BUT NOT TERRIBLY AND THERE WAS NO TREND PARTICULARLY OVER TIME. WE WERE CONCERNED BEFORE 2017 IT MIGHT DECLINE BUT IT CAME BACK UP SO THERE'S NO EVIDENCE OF A TREND. ABILITY 16.7% OF AWARDS PREVENTION UNDER OUR DEFINITION. PROPORTION IS HIGHER IN TERMS OF DOLLARS, 22.6 PERCENT. WE HAD A BIG BUMP IN 201 WHEN NIAID ISSUED PRICEY UN 1 AWARDS. THESE ARE THEIR NETWORK AWARDS. VERY VALUABLE AWARDS. THAT BUMPED THAT DOLLAR FIGURE UP THOUGH IT DIDN'T CHANGE NUMBER OF AWARDS VERY MUCH. THE ACTIVITY CODES DIFFER CONSIDERABLY IN THEIR CONCENTRATION PREVENTION RESEARCH PROJECTS SO IF WE LOOK AT UO 1 WE SEE HIGH FRACTION OF PREVENTION AWARDS. POs, LOW FRACTION PREVENTION BOARDS, RO1 CAME AT 16.1% BECAUSE THE MOST COMMON, THAT'S CLOSE TO THE ACTUAL ARCH OBSERVED. NOW LET'S TAKE A LOOK MORE DEEPLY AT PROJECTS CODED AS PREVENTION AND CHARACTERISTICS. ONE OF THE MOST NOTABLE THINGS IN TERMS OF GENDER AND MINORITY INCLUSION CODES WAS SO MANY AWARDS DIDN'T HAVE ONE. WE WERE MISSING GENDER INCLUSION CODE FOR 24% PROJECTS AND THE MINORITY INCLUSION CODE FOR 30% OF THE PROJECTS. OTHERWISE BOTH GENDERS QUITE COMMON, MINORITY AND NON-MINORITY POPULATIONS IS QUITE COMMON. WE HOPE TO DO A FAR BETTER JOB IN THESE TWO CATEGORIES AS WE MOVE FORWARD WITH THE NEXT PHASE OF OUR CODING. BEGINNING WITH FY 18 AWARDS. WE HOPE TO PROVIDE MORE DETAIL HERE. STUDY DESIGN, OF INTEREST TO ME, METHOD DOLL GIST, EPIDEMIOLOGIST AND I WANTED TO KNOW WHAT STUDIES FOR STUDY DESIGNS BEING USED IN PREVENTION RESEARCH, 63% PREVENTION AWARDS INCLUDED OBSERVATIONAL STUDY. 43% HAD ANALYSIS OF EXISTING DATA NOT MUTUALLY EXCLUSIVE, IT'S CHECK NUMBERS THAT APPLY SO THEY DON'T ADD TO 100. 24% INCLUDED METHODS WORK. ONLY 18 INCLUDED RANDOMIZED INTERVENTION. I PAUSED WHEN I SAW THAT. I WAS SURPRISED. IT'S -- THIS IS FY 12 TO 17. I WAS PUZZLED AT WHY WE WERE STILL DOING LOTS OF OBSERVATIONAL STUDIES, LOSS OF SECONDARY DATA ANALYSES, ONLY 18% PROJECTS INCLUDED RANDOMIZE TRIAL TO EVALUATE INTERVENTION. WE KNOW A LOT ABOUT RISK FACTORS. SEEMS TO ME WE OUGHT TO BE DOING MORE INTERVENTION STUDIES AND TRIALS TO EVALUATE THEM. HEN WE LOOK AT POPULATIONS STUDIED, MOST AWARDS TITLE ABSTRACT DON'T GIVE MUCH DETAIL ABOUT POPULATIONS THEY STUDY, SO THAT FELL INTO ADULT OR UNCLEAR CATEGORY. YOUTH WERE IDENTIFIED BY PRETTY GOOD FRACTION, URBAN OLDER ADULTS AS WELL AND THEN IT DROPS OFF AFTER THAT. LGBTI WAS IDENTIFIED A SPECIAL FOCUS GROUP, 2 ANTI-6% OF AWARDS. WE LOOKED AT THE RATIONALES PROVIDED FOR THE RESEARCH, WHAT ARE THE MOTIVATING FACTORS. MORTALITY CAME AT THE TOP OF THE LIST, CANCER, INFECTIOUS DISEASE, MATERNAL, PATERNAL, CHILD HEALTH AND OTHER FAMILIAR ITEMS, MOST OF THESE WERE DISEASES OR HEALTH CONDITIONS, RISK FACTORS STARTED POPPING UP DOWN TO OBESITY, TOBACCO, ALCOHOL, SO FORTH BUT MOST WERE LEADING KAWS OF DEATH AS OPPOSED TO RISK FACTORS. FROM WHAT WERE EXPOSURES. WE DIDN'T DO AS WELL IDENTIFYING COMING UP WITH CATEGORIES OF EXPOSURE, THERE'S A LOT IDENTIFIED AS OTHER. FOR THE ONES THAT DID COME IN, GENETICS WAS THE TOP OF THE PILE, HOW CAN GENETICS BE EXPOSURE? IT'S EXPOSURE IN GWAS STUDIES, WHERE PEOPLE VALUE PARTICULAR VARIANT, THEIR EXPOSURE WHAT IS THE OUTCOME DOWN THE ROAD. THERE'S LOTS OF WAYS GENETICS IS EXPOSURE. EDUCATION COUNSELING, COMMON EXPOSURE OF MEDICATION DEVICE NO SURPRISE, DIET OR CHEMICAL TOXIN OR SUBSTANCE ABUSE, THOSE WITHIN EXPOSURES JUST LIKE GENETICS CAN BE. YOU IDENTIFY A POPULATION THAT INCLUDES SUBSTANCE USERS AND NON-SUBSTANCE USERS AND HOW THEY DIFFER IN INCIDENCE OR PREVALENCE SOMETHING. AND THAT'S HOW THOSE FACTORS SERVE AS EXPOSURE. IN TERMS OF OUTCOMES. CANCER WAS IDENTIFIED MOST COMMONLY AS AN OUTCOME, INFECTIOUS DISEASE, HEALTHCARE DELIVERY, MENTAL HEALTH, SO FORTH DOWN THE LINE. THE BEHAVIORAL RISK FACTORS APPEAR FURTHER DOWN THE LIST YOU WILL SEE THEM THERE. INTEREST IN COMPARING THESE PATTERNS LEADING CAUSES AND RISK FACTORS. LEADING CAUSES CDC, 2015 VALUE SHOW HERE AND GLOBAL BURDEN OF DISEASE PROJECT IS IN THEIR 2016 DATA. YOU SEE HEART DISEASE AN CANCER, HAS A FAIR AMOUNT OF ACTIVITY IT FALLS OFF AFTER THAT. WHEN WE LOOK AT THE LEADING RISK FACTORS, NOTHING WAS OVER 10% EXCEPT IF WE HAD ALCOHOL SEPARATE FROM DRUG USE IT WOULD BE 5% RANGE. WE LOOK AND THINK IS THIS APPROPRIATE? NOBODY HAS EVER SAID THIS IS HOW MUCH WE ARE PUTTING INTO EACH OF THESE AREAS IN TERMS OF PREVENTION. THIS IS HOW MUCH WE OUGHT TO PUT INTO RISK FACTORS OPPOSED TO CAUSES. THIS IS THE FIRST TIME YOU HAVE BEEN ABLE TO SEE WHAT WE'RE PUTTING IN. EVEN IF THERE IS NOT A GRAND PLAN. MOST IS ANALYSIS OF EXISTING DATA AND OBSERVATIONAL STUDIES. RANDOMIZED INTERVENTION, NOT COMMON. COUPLE OF EXCEPTIONS, DIABETES, SUICIDE, STROKE. THOSE ARE CONDITIONS WHERE OUTCOME IS OBSERVED MORE RAPIDLY AFTER THE INTERVENTION OR CAN BE. SO THAT MAKES SENSE, FOR SOMETHING LIKE CANCER WHERE YOU HAVE A VERY LONG DEVELOPMENT PERIOD, NOT SURPRISE WE SEE LOWER FRACTION OF STUDIES THAT EMPLOY RANDOMIZED INTERVENTION. WHEN WE LOOK AT THE RISK FACTORS, WE SEE A SHIFT THERE'S STILL GOOD OBSERVATIONAL STUDIES AND ANALYSIS AND EXISTING DATA BUT WE SEE MORE RANDOMIZED INTERVENTIONS BECAUSE IT'S WE CAN SEE CHANGE IN PHYSICAL ACTIVITY, OR IN OBESITY OR TOBACCO USE, MORE EASILY MORE QUICKLY THAN WE SEE CHANGES IN INCIDENCE OF DISEASE. SO WE CODED OVER 11,000 PROJECTS, FUNDED DURING FY 12 TO 17 FOR THIS EFFORT. THOSE CODES REPRESENT 92% OF RESEARCH PROJECTS THAT NIH SUPPORTS FUNDED BY RP AND U ACTIVITY CODES AND 84.1% DOLLARS USED FOR THIS PROJECT. WE THINK WE REPRESENTED THE PORTFOLIO WELL. BASED ON OUR WORK, 16.7% PROJECTS ATRESS PRIMARY OR SECONDARY RESEARCH IN HUMANS OR METHODS PROJECTS TO SUPPORT THAT RESEARCH. IF WE THINK IN TERMS OF DOLLARS, IT'S 22.6%. 63% PROJECTS INCLUDED OBSERVATIONAL STUDY, 43% ANALYSIS EXISTING DATA. 24% METHODS RESEARCH, ONLY 18% RAN COMIZE INTERVENTION, A LITTLE ARITHMETIC, MULTIPLICATION WILL TELL YOU THAT MEANS OF THE ENTIRE NIH RESEARCH PORTFOLIO ONLY 3% PROJECTS SUPPORT RANDOMIZE PREVENTIVE INTERVENTIONS. THAT SEEMS TO BE A LOW NUMBER, I'M INTEREST IN YOUR THOUGHTS DURING THE DISCUSSION PERIOD. PARTICULARLY WHEN 74% VARIABILITY IN COUNTY WIDE OR COUNTY LEVEL LIFE EXPECTANCY IS EXPLAINED BY ESTABLISHED RISK FACTORS, SEEMS APPROPRIATE TO ME TO DEVOTE ADDITIONAL RESOURCES TO EVALUATE PREVENTATIVE INTERVENTIONS TO ADDRESS THOSE RISK FACTORS. WE PUBLISHED THE METHODS AND THE RESULTS RECENTLY JUST IN NOVEMBER, IN AMERICAN JOURNAL PREVENTIVE MEDICINE AND REFERENCES ARE PROVIDED HERE. NEXT STEPS FOR US WE ARE WORKING WITH COLLEAGUES ACROSS THE INSTITUTES CENTERS AND OFFICES TO EXAMINE OUR DATA. FOR THEIR INTEREST AND CONSIDER IMPLICATIONS FOR THEIR WORK GOING FORWARD. WE ARE MAKING IC SPECIFIC DATA AVAILABLE TO THEM IF THEY WANT IT. WE WILL CONTINUE TO SHARE OUR FINDING WITH RCDC BECAUSE IT'S ONE OF THE FEW SITUATIONS WHERE THEY HAVE A LARGE SCALE DATA SET WITH VALIDATED RESULTS FOR SO MANY AWARDS, THEY CAN IMPROVE THEIR METHODS BY USING OUR CODED DATA. WE ARE EXTENDING THE MACHINE LEARNING ALGORITHMS TO LOOK AT OTHER CATEGORIES SO FARCE PREVENTION VERSUS NOT PREVENTION BUT LOOK AT OTHER THINGS AS WELL. WE'D LOVE TO REDUCE MANUAL CODING THAT WE HAVE TO PAY FOR. AND THAT WE HAVE TO DO. AND THE QUALITY CONTROL THAT WE HAVE TO DO BEHIND IT. WE WILL USE RESULTS NOW THAT WE CAN IDENTIFY PROJECTS THAT QUALIFY UNDER OUR DEFINITION. WE CAN USE THE HOST OF TOOLS OFFICE PORTFOLIO ANALYSIS DEVELOPING AND RESOURCES TO EVALUATE IMPACT OF THAT RESEARCH, PARTICULAR FOCUS FOR US DURING OUR SECOND STRATEGIC PLANNING PERIOD. WE WILL CODE FY 18 AWARDS, I HOPE IN FEBRUARY. BE DUB BY FISCAL YEAR AND JUMP INTO FY 19. THIS IS A LIST OF SOME OF THE PEOPLE THAT HAVE BEEN INVOLVED IN IF PROJECT. AGAIN, DR. SHELLEY'S TEAM IS CENTRAL, GEORGE'S TEAM OPA IS INVALUABLE, CONTINUES TO BE. THIS IS A LIST OF CONTRACTORS FROM OUR ORIGINAL CONTRACTOR, WE CHANGED TEAMS IN THE LAST 12 MONTHS. SO THESE FOLKS ARE NOT WORKING SHOW THIS SLIDE IT WILL HAVE A DIFFERENT CONTRACTOR. BE HAPPY TO TAKE QUESTIONS. ANY QUESTIONS YOU HAVE ABOUT THIS WORK. YES. >> SO APPRECIATE YOUR CALLING ON ME, I HAVE TO LEAVE AFTER QUESTION BECAUSE OF MOBILITY. >> PLEASE STAY FOR THE ANSWER. >> SO THERE'S AN INCREDIBLY INTERESTING STUDY THAT CAME OUT LAST WEEK IN NATURE GENETICS, IT WAS A HUGE ASSURANCE DATA SET BASED ICD 9 STUDY OF 49,000 PEOPLE COMPARING IDENTICAL TWINS TO SIBS TO TRY TO SEE GENETIC CONTRIBUTION ENVIRONMENTAL CONTRIBUTION OF DISEASE. THERE'S A HUGE GENETIC CONTRIBUTION, 40% OR SOMETHING LIKE THAT. THERE'S AN ENVIRONMENTAL COMPONENT, THERE'S LIMITATIONS IN THE STUDY BUT IT WASN'T AS BIG, LIKE 20% BUT IT'S A LOT. REALLY INTERESTING THING WHEN THEY STRATIFY RISK THE THINGS PEOPLE SAY OR THE RISK FACTORS INCLUDING MANY OF THE THINGS ON THE LIST THERE. AT LEAST ICD 9 CODE, OBESITY, THING LIKE THAT. ONLY ACCOUNTED FOR 2% SO THERE'S A BLACK HOLE OF RISK FACTORS, MANY BEING THAT IN TERMS OF JUST YOUR OFFICE IN GENERAL BUT ALSO IN TERMS OF PREVENTION, THERE'S THIS LACK OF INFORMATION ABOUT WHAT MIGHT BE MAJOR ENVIRONMENTAL EXPOSURES THAT ARE CONTRIBUTING TO -- >> I HAVEN'T SEEN THIS PAPER SO I CAN'T COMMENT ON IT SPECIFICALLY. IT'S RUNNING COUNTER WHAT YOU DESCRIBE IS CONTRARY TO WHAT I HAVE SEEN ELSEWHERE. SO THE GLOBAL BURDEN OF DISEASE PROJECT IN THEIR 2016, 17, 18 PAPERS HAVE IDENTIFIED THE RISK FACTORS THAT I HAVE ON THE SLIDE AS ACCOUNTING FOR A LARGE FRACTION OF THE VARIABILITY AND COUNTY LEVEL MORTALITY, FOR EXAMPLE. OR LIFE EXPECTANCY. EVEN AFTER ADJUSTING FOR SES FACTORS, AFTER ADJUSTING FOR HEALTHCARE ACCESS AND OTHER THINGS, THEY DIDN'T INCLUDE GENETICS. >> I MAY HAVE MISSPOKEN. THEY ARE TALKING ENVIRONMENTAL EXPOSURE. SO OBESITY, THAT SORT OF THING WOULDN'T BE ON THE LIST SO IT'S REALLY THINGS LIKE TOXIC EXPOSURE OR -- >> THOSE FACTORS ARE ACCOUNTING FOR A SMALL FRACTION. >> WHEN THEY LOOK AT THEM SPECIFICALLY BUT THERE MUST BE THINGS THAT ARE MORE THAN THAT THAT ARE CONTRIBUTING. >> I HAVE TO LOOK AT THE PAPER. >> YOU ARE RIGHT. >> WHAT WE HAVE SEEN IS BEHAVIORAL RISK FACTORS ACCOUNTING FOR AWFUL LOT OF WHAT WE CARE ABOUT. WE KNOW A LOT AND FAIR AMOUNT ABOUT WHAT TO DO ABOUT THEM, WE NEED TO LEARN MORE, THAT'S THE AREA I ADVOCATE FOR MORE RESEARCH. >> SO THAT WAS REALLY INTERESTING, OBVIOUSLY CRITICALLY IMPORTANT QUESTION, WHAT ARE PREVENTABLE CAUSES OF DISEASE. MY QUESTION, YOU ARE LOOKING AT THE NIH ALONE BUT WE EXIST IN ECOSYSTEM OF OTHER RESEARCH FUNDERS. THERE ARE MANY, MANY DISEASE FOUNDATIONS THAT ARE DISEASE SPECIFIC. WHEN YOU INCORPORATE THOSE, AND PHARMA INTO WHAT SORTS OF STUDIES ARE BEING DRIVEN OR SUPPORTED TO ASK THESE QUESTIONS, DOES IT BECOME MORE BALANCED ONE REAL IMPORTANT THING TO RECOGNIZE IS ONE PIE ANY TIME YOU TAKE RESOURCES FROM SOME ASPECT OR GIVE TO ONE ASPECT YOU TAKE FROM ANOTHER. SO THIS IS A RESERVING IS ECOSYSTEM QUESTION, NOT JUST UNIQUE NIH QUESTION. >> I WOULD AGREE OR WOULD RECOLLECT IS LIMBED TO THE NIH PORTFOLIO. SO I CAN'T EXPAND BEYOND THAT, WE HAVEN'T INCLUDED IT. >> I UNDERSTAND THAT. JUST THINKING ABOUT WHETHER OR NOT THERE SHOULD BE A REDIRECTION OF RESOURCES. THAT IS SOMETHING TO THINK ABOUT. >> FOR WHAT WE ARE PROVIDING FOR THE INVESTIGATORS IN THE COUNTRY. >> WHEN I THINK ABOUT REDIRECTION, I'M NOT MAKING ARGUMENT TAKE MONEY FROM BASIC SCIENCE AND PUT INTO PREVENTION RESEARCH. I'M LOOKING WHAT WE ARE SPENDING ON PREVENTION RESEARCH AND SUGGESTING DO WE NEED TO SUPPORT 63% PROJECTS TO DO OBSERVATIONAL STUDIES? NEED TO SUPPORT 43% TO DO SECONDARY DATA ANALYSIS? WHY ONLY SUPPORTING 18.2 STUDIES EVALUATING INTERVENTIONS TO DO SOMETHING ABOUT THE RISK FACTOR? WE COULD DO SOME INTERNAL REALLOCATION WITHOUT SHIFTING DOLLARS FROM OTHER AREAS. AND PROBABLY MAKE MORE PROGRESS. THAT CLARIFIES, THANKS. >> I'M INTERESTED IN FEEDBACK FROM THIS GROUP, IF YOU SUPPORT THAT, THAT WOULD BE USEFUL TO KNOW. >> WE CAN ALSO LOOK AT PUBLICATIONS WHICH HAD -- ASSUMING THAT PHARMA PUBLISHES THAT TYPE OF RESULT. BUT THERE ARE OTHER DATABASES. >> MANY ANALYSIS IS A REALLY IMPORTANT ANALYSIS. >> THANK YOU VERY MUCH. UC DAVIS. I WAS FASCINATED BY THE STUDY DESIGN ON SLIDE 23 VERSUS TYPE OF FUNDING MECHANISM. DID YOU FIND THAT CERTAIN MECHANISMS FAVOR CERTAIN STUDY DESIGNS? AND AS FOLLOW-UP, COULD YOU -- AS YOU MENTION, IF YOU WANTED TO PUT YOUR -- IF MONEY TOWARDS MORE RANDOMIZE INTERVENTION, WHICH TYPE OF MECHANISM WOULD YOU FAVOR? >> I HAVE NOT LOOKED AT STUDY DESIGN CROSS SELECTIVITY CODES, INTERESTING QUESTION, WE COULD EASILY DO THAT. DR. SHELLEY MAY HAVE THAT AT HER FINGERTIPS. IF YOU DO, SPEAK UP. >> NCI MADE CATEGORY TO GET COHORTS ALL IN ONE FUNDING POT TO SORT OF CAP THE AMOUNT OF MONEY GOING INTO THE PROSPECTIVES OBSERVATIONAL STUDIES. TO ME, THAT PROBABLY IS A BIG CHUNK OF THE -- >> IF IT WOULDN'T SURPRISE ME IF THERE WAS DRAMATIC DIFFERENCES BETWEEN ACTIVITY CODES AND DISTRIBUTION OF STUDY DESIGN. THAT'S ALMOST CERTAINLY TRUE, NOT SOMETHING WE HAVE LOOKED AT YET BUT CERTAINLY CAN. >> I WANT TO THANK YOU FOR THIS PRESENTATION. IT'S VERY INFORMATIVE. AND REGARDLESS OF WHAT THE RIGHT PERCENTAGE IS IN TERMS OF HOW MUCH TREATMENT VERSUS PREVENTION RESEARCH, IT DOES SPEAK TO THE FACT THAT WE SHOULD BE HAVING THAT CONVERSATION. IN FACT TALKING ABOUT WHAT TYPES OF STUDY DESIGNS AND WHY IS IT THAT WE'RE NOT GETTING MORE CLINICAL TRIALS, IS IT BECAUSE OF THE FACT THAT THE WAY CLINICAL TRIALS ARE BEING DESIGNED IN THE LEVEL OF PERFECTION WE ARE ASKING WITHIN CLINICAL TRIALS PERHAPS IS INHIBITING OUR ABILITY TO BE ABLE TO HAVE HUMANS PARTICIPATE IN THEM. I SPEAK THIS AS RESEARCHER AT BEHAVIORAL INTERVENTIONS AND THE NEW CONCEPT OF AGILE SCIENCE AND THE FACT WE MIGHT HAVE TO RETHINK HOW WE ENROLL INDIVIDUALS INTO CLINICAL TRIALS AND ASSIGN THEM TREATMENT WITHOUT REALLY UNDERSTANDING WHAT IT IS THAT THEY'RE MORE LIKELY TO PARTICIPATE IN ENHANCING THEIR SUCCESS IN WHATEVER TREATMENT IT IS WE ARE TRYING TO GIVE. IT'S A GREAT DISCUSSION. NO ANSWERS RIGHT HERE. BUT I REALLY DO THINK IT'S SOMETHING WORTHY OF US EXPLORING A LITTLE BIT MORE. >> ONE THING I HEAR FROM THE IC IS THINK SPEAK WITH DIRECTORS AND OTHER STAFF, IS THAT DAVID RANDOMIZED TRIALS ARE MORE EXPENSIVE, COPPING DOESN'T WANT TO DO FEWER STUDIES. HOW ARE WE GOING TO DO MORE RANDOMIZED TRIALS. MY RESPONSE TENDS TO BE WE SHOULD BE DOING WHAT WILL ADVANCE THE SCIENCE, NOT JUST WHAT IS INEXPENSIVE. YES. >> SO THANKS FOR THIS, I JUST WONDER WHETHER THERE ARE OTHER OPPORTUNITIES HERE TO BUILD ON THIS PAGE GREEN AT NCI TO REVIEW 600 RANDOMIZED TRIALS THAT'S FINALLY ABOUT TO BE PUBLISHED. THAT PROCESS SHOWED AMAZING GAPS IN AGE AND MULTI-MORBIDITY SOME OF THESE SAME REPORTING ISSUES THAT YOU ARE HAVING TROUBLE WITH IN GRANT APPLICATION DETAIL. WE HAVE SAME TROUBLE WHEN THE RCTs ARE PUB ESTABLISHED SO I EXPECT -- PUBLISHED SO THERE'S SOME EXISTING DATA THAT MIGHT BE INTERESTING CROSS VALIDATION FINAL OUTCOME OF SOME OF THESE. EVERYTHING FUNDED DOESN'T GET PUBLISHED. I PRESUME. THE OTHER WAY ON THE ECOSYSTEM OUT OF THESE 600 RANDOMIZE TRIAL SAMPLED OVER 15 YEARS ALL NIH FUNDED BECAUSE WE EXCLUDED DRUGS. OTHER WAYS TO ROUND OUT SOME OF THESE QUESTIONS, WAITING TO HAPPEN. >> I WAS CURIOUS, 3% YOU POINTED OUT, DO YOU HAVE SENSE HOW MANY ARE DRIVEN BY SPECIFIC RFAs FOR PREVENTION RESEARCH VERSUS DE NOVO RO1s PO 1s. >> NOT SOMETHING WE LOOKED AT YET SO THOSE DATA SO WE CAN. >> >> IT MAYBE INFORMATIVE SO MAY GET TO SOMETHING HAD TALKED ABOUT. IT'S THE ISSUE THAT PERCEPTION OF THE NEED FOR PERFECT PRELIMINARY DATA BEFORE YOU CAN BE SUCCESSFUL AT A DE NOVO RO1 PO 1 U IS INHIBITING PEOPLE THAT ARE PREVENTIVE RESEARCHERS FOR EVEN APPLYING BECAUSE YOU DON'T HAVE THAT KIND OF DATA PRELIMINARILY TO GET SOMETHING THROUGH THOSE HURDLES. THAT WOULD SUGGEST AGAIN ANOTHER WAY OF LOOKING AT HOW WE ARE VIEW AND ASSESS SIGNS NIH WIDE. >> GOOD IDEA. >> SLIDE 23, SLIDE 24, I THOUGHT NUMBER PERCENTAGE OF VETERANS 1.2% PERSONS WITH DISABILITIES 2.5% SEEMED LOW. BUT I DON'T KNOW ENOUGH ABOUT THE NATURE OF MOST PREVENTIVE STUDIES. >> THOSE FIGURES ALL THE FIGURES IF ON THAT SLIDE, AND THE OTHER SLIDES, COME FROM WHAT INVESTIGATORS PUT IN THEIR TITLE ABSTRACT PUBLIC HEALTH RELEVANCE. THEY MAY VERY WELL BE FOCUSED HEAVILY ON VETERAN POPULATION BUT IF THEY DON'T TELL US THAT IN THE TITLE ABSTRACT PUBLIC HEALTH RELEVANCE, IT'S VOTED ADULT OTHER. SO 1.5 OR 2.5% TOLD US THEY WERE FOCUSED ON THOSE POPULATIONS. MANY OTHERS WOULD HAVE INCLUDED REPRESENTATIVES FROM THOSE POPULATIONS. WHICH JUST DIDN'T POINT TO IT IN ABSTRACT. YES. >> >> I THINK THERE ARE SOME SIGNIFICANT BARRIERS NOT APPOINTED VA FOR INCLUDING VETERANS AND GETTING A HUMAN STUDIES APPROVED IN THE VA SYSTEM. THAT MAYBE A BARRIER THAT IS SORT OF FUNCTIONAL THAT PREVENTS THAT NUMBER FROM BEING HIGHER. >> OTHER QUESTIONS, COMMENTS. THANK YOU VERY MUCH. >> THANK YOU VERY MUCH, DAVID THIS IS AN EXAMPLE OF WHAT OUR DIVISION DOES. EVERYTHING WE DO IS NIH WIDE IN TERMS OF COORDINATION PLANNING AND STRATEGIC INITIATIVE. SOMETIMES IT LEADS US TO DO PROPROJECTS THAT ARE PROVOCATIVE, WE NEED YOUR INPUT ADS WE APPROACH THE INDIVIDUAL INSTITUTES HOW TO INTERPRET AND WHAT WE SHOULD DO ABOUT IT CORPORATELY. SO THANKS FOR YOUR INPUT. UNLESS YOU HAVE ANYTHING TO ADD TODAY, I'LL THANK YOU ALL FOR YOUR INPUT, DISCUSSIONS, WE DID OUR WORK TODAY GOT SOME GREAT IDEAS AND WE WILL SEE YOU MAY 17th. THANK YOU.