>>WELCOME TO THE SUB COUNCIL MEETING OF THE DIVISION OF MICROBIOLOGY INFECTIOUS DISEASES. CAN YOU FORWARD THE SLIDE PLEASE? I DON'T THINK I'M IN CONTROL. THANK YOU. OUR AGENDA FOR TODAY, I'M GOING TO START WITH THE DIRECTORS REPORT, THAT WILL INCLUDE AN UPDATE ON PERSONNEL CHANGES, A FEW HIGHLIGHTS FROM OUR RESEARCH NEWS HERE AT DMID AND THEN THERE WILL BE FOUR SBIR CONTRACT TOPICS THAT I'LL PRESENT AS CONCEPTS FOR YOU CONSIDERATION AND HOPEFULLY APPROVAL, ECB RECORD. THIS WILL FOLLOW WITH AN UPDATE FROM THE NIAID OFFICE OF RESEARCH TRAINING AND SPECIAL TRAINING PROGRAM, DR. PRICE WITH US TODAY. THIS IS BASED UPON REQUEST THAT COUNCIL MEMBERS EXITING IN THE PAST, THEY ASK TO HEAR MORE ABOUT TRAINING PROGRAMS. SO WE ARE COMPLYING WITH THAT, JUST ISN'T THE SAME GROUP OF PEOPLE THAT SHE'S PRESENTING TO THAN THE REQUEST CAME FROM. THEN WE HAVE FIVE FY 24 CONCEPTS FOR YOUR CONSIDERATION AND APPROVAL. THE LAST CONCEPT ON THE LIST THE REVAMP CENTERS ACTUALLY IS A BUNDLE OF THREE DIFFERENT RFAs. SO WE WILL GET STARTED. NEXT SLIDE PLEASE. FIRST WE HAVE NEW COUNCIL MEMBERS. YOU HEARD ABOUT THIS EARLIER TODAY. DR. MARY ESTES COMES FROM BAYLOR, DISTINGUISHED SERVICE PROFESSOR DEPARTMENT OF MOLECULAR VIROLOGY AND MICROBIOLOGY IN THE DEPARTMENT OF MEDICINE, GASTROENTEROLOGY AND HEPATITIS AS WELL AS INFECTIOUS DISEASE. SHE'S THE EMERITUS FOUNDING DIRECTOR OF NIH FUNDED ADJUSTED DISEASES CENTER WHICH SUPPORTS COLLABORATIVE RESEARCH ACROSS MULTIPLE INSTITUTION INSTITUTIONS AT THE TEXAS MEDICAL CENTER HER RESEARCH FOCUSES ON VIRAL INFECTIONS OF GI TRACT. DR. PALMER IS REGIONS PROFESSOR VIROLOGY AND INFECTIOUS DISEASE AND THE JAN AND JACK ENDOWED CHAIR WASHINGTON STATE UNIVERSITY, WSU FOUNDING DIRECTOR PAUL ALLEN SCHOOL FOR POLITICAL HEALTH. HE SERVED AS DIRECTOR OF GLOBAL HEALTH FOR THE WSU SYSTEM AND COMBINES LABORATORY RESEARCH EPI STUDIES AND FOCUSED ON MICROBIAL ANGIOGENIC VARIABLE IMMUNE INNOVATION AND ZOONOTIC FACTORS ON IMMUNE HEALTH. NEXT SLIDE PLEASE. WE HAVE A NEW EX-OFFICIO MEMBER DR. DAN JERNIGAN WHO WAS WITH US IN THE MORNING SESSION. HE'S CURRENTLY ACTING DIRECTOR OF THE NATIONAL CENTER FOR EMERGING ZOONOTIC INFECTIOUS DISEASE. BEFORE HE ACCEPTED THIS INTERIM POSITION WITH NCEZIT HE WAS THE CDC DEPUTY DIRECTOR OF PUBLIC HEALTH SCIENCE AND SURVEILLANCE. AND BEFORE THAT, WHILE HE WAS DIRECTOR AT THE I HAVE BEEN FLUENCY NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES. AFTER HE COMPLETED 23 YEARS OF SERVICE IN 2019 HE RETIRED FROM THE DIVISION CORPS AS CAPTAIN AND CONTINUING AS CIVIL SERVANT IN THE CDC ROLES THAT I DESCRIBED SO WELCOME TO MARY GUY AND DAN. VERY GLAD TO HAVE YOU HERE. NEXT SLIDE PLEASE. WE HAVE NEW DMID STAFF TO WELCOME, DR. MICHAEL ISAN APPOINTED THE NEW BRANCH CHIEF IN RESPIRATORY DISEASES BRANCH AND DR. (INAUDIBLE) MENTION THIRD DEGREE IN HIS REMARKS EARLIER THIS MORNING. HE COMES FROM NORTHWESTERN UNIVERSITY SCHOOL OF MEDICINE, PROFESSOR OF MEDICINE AND HE DIRECTED THE TRAININGS PLANT ID SERVICE. HE IS INTERNATIONALLY RECOGNIZED IN VIRAL RESPIRATORY INFECTIONS, AND IN THEIR TREATMENT. AS WELL AS GENERALLY INFECTIONS AND ORGAN TRANSPLANT RECIPIENTS. HE'S PI OR A SITE PI AT NUMBER OF DMID FUNDED CLINICAL TRIALS AND RECENTLY HE SERVED AS THE DSMB CHAIR FOR OUR ACT STUDIES, THE ACT STUDIES LED TO AUTHORIZATION AMONG OTHER INTERVENTIONS. WE HAVE A NUMBER OF OTHER NEW DMID STAFF. KATE BRADFORD JOINED THE RESPIRATORY DISEASE BRANCH IN 2021, AS AAAS SCIENCE AND TECHNOLOGY POLICY FELLOW. DURING HER TIME WITH US AS A FELLOW, SHE PERFORMED EXTENSIVE PORTFOLIO ANALYSIS OF THE NIAID UNIVERSAL INFLUENZA VACCINE. STRATEGIC PLAN ACTIVITIES RELATED TO THE STRATEGIC PLAN. SHE TOOK ON MORE DUTIES WITH US IN RUNNING THE COMMITTEE THAT LOOKS AT ENHANCED PPP AND DRK PROJECTS AND NOW SHE'S PROGRAM OFFICER TAKING OVER THE CORONA VIRUS PATHOGEN BIOLOGY RESEARCH PROGRAM. THEN FANA SEGUNDO A NEW MEMBER OF THE RESEARCH RESOURCE -- RESEARCH RESOURCES SEC IN THE OFFICE OF BIODEFENSE RESEARCH RESOURCES AND TRANSLATIONAL RESEARCH OTHERWISE KNOWN AS OBRRTR. SHE WILL OVER SEE DEVELOPMENT AND ANIMAL MODELS SPECIAL DISEASES RELATED TO THE ANTIVIRAL PROGRAM FOR PANDEMICS. AND OVERSEEING AND DRIVING THE WORK AT IS THE REGIONAL BIOCONTAINMENT LABS AND THE FUNDING OF THOSE LABORATORIES. MORE NEW STAFF, BRENDA DORSEY OFFICE OF CLINICAL RESEARCH AFFAIRS AS SENIOR QUALITY ASSURANCE MANAGER. PRIOR TO DMID SHE WAS AT UNIVERSITY OF MARYLAND CENTER FOR VACCINE DEVELOPMENT AND GLOBAL HEALTH WHERE SHE SERVED DIRECTOR OF QUALITY ASSURANCE AND SHE IS BRINGING THOSE SKILLS FROM UNIVERSITY OF MARYLAND TO DMID AND SHE WILL LEAD OUR QUALITY ASSURANCE EFFORTS FOR CLINICAL TRIALS. THEN DR. KEVIN SCHULLY JOINED THE CLINICAL RESEARCH SECTION AS SCIENTIFIC CLINICAL LEAD. HE -- SINCE 2010 HE'S BEEN WORKING IN AT FORT DEE TRICK IN THE BIOLOGIC DEFENSE RESEARCH DIRECTORATE FOR THE NAVY MEDICAL RESEARCH CENTER INVOLVED IN VACCINES AND DEVELOPMENT AS WELL AS OTHER MEDICAL COUNTER MEASURES. HE WILL HELP SUPPORT VACCINE CLINICAL TRIAL EFFORTS THROUGH THE NIAID INFECTIOUS DISEASE CLINICAL RESEARCH CONSORTIUM, OUR NETWORK, KNOWN AS THE IDCRC. ALSO ADDITIONAL SUPPORT TO OUR CLINICAL EFFORTS ACROSS THE RESPIRATORY DISEASE BRANCH. MICHELLE ARNOLD JOINED THE RESPIRATORY DISEASE BRANCH THERE, PRIOR TO GETTING ALL THE NEW STAFF ON BOARD SHE WILL MANAGE THE INFLUENZA AND CORONA VIRUS IMMUNITY RESEARCH PORTFOLIO. SHE DID HER POST-DOCTORAL TRAINING IN THE LABORATORY OF INFECTIOUS DISEASE HERE AT NIAID. WHERE SHE STUDIED RHODA VIRUS, SHE SPENT TIME IN ACADEMIA JOINING NIH FOR CENTER E FOR SCIENTIFIC REVIEW AS SCIENTIFIC REVIEW OFFICER. KEEHWAN KWON OFFICE OF GENOMICS AND APPLIED TECHNOLOGIES AT OGAT AND HE WILL MANAGE THE PORTFOLIO THAT'S FOCUSED ON STRUCTURAL BIOLOGY. HE SPENT TIME AT THE INSTITUTE FOR GENOMIC RESEARCH OTHERWISE KNOWN AS TIGER AND THE J CRAIG VENTURE INSTITUTE JCBI AS WELL AS GLAXOSMITHKLINE. HE HAS EXPERIENCE IN MULTIPLE PROGRAMS ON PROTEOMIC, STRUCTURAL GENOMICS, VACCINE DEVELOPMENT AND SYNTHETIC BIOLOGY. AND JUST BEFORE COMING TO US HE LED THE DRUG DISCOVERY TEAM AT ATCC WHERE HE ENHANCED REPURPOSING DRUG DISCOVERY PLATFORM FOR EMERGING AND RE-EMERGING VIRUSES. NEXT SLIDE PLEASE. WE HAVE HAD SOME PEOPLE WHO LEFT ON HAPPY NOTE, HAPPY FOR THEM, THEY RETIRED. KAREN BAITMAN WAS HERE FOR DECADES ACTUALLY, WORKING IN THE BRANCH OPERATIONS TEAM AS TEAM LEAD. AND TINA PARKER AND MICHAEL SCHAEFER OFFICE OF BIODEFENSE AND RESEARCH RESOURCES AND TRANSLATIONAL RESEARCH THEY BOTH RETIRED. NEXT SLIDE PLEASE. AND IN THE MIDDLE THERE WITH KAREN HE RETIRED FROM THE VIROLOGY BRANCH SERVED AS BASIC RESEARCH SECTION CHIEF. SO WE MISS THEM BUT THEY ARE -- THEY MOVED ON TO GREATER PASTURES. NEXT SLIDE PLEASE. I'M GOING TO GIVE YOU UPDATES ON SOME OF OUR RESEARCH ACTIVITIES. IN RESPONSE TO APPROPRIATIONS LANGUAGE FROM CONGRESS, WE WERE ASKED TO CREATE A STRATEGIC PLAN FOR RESEARCH TO DEVELOP VALLEY FEVER VACCINE, A VACCINE THAT WORKS AGAINST A HUGE PROBLEM IN A RELATIVELY CIRCUMSCRIBED PART OF THE UNITED STATES, CENTRAL VALLEY OF CALIFORNIA AND PARTS OF SOUTH WESTERN UNITED STATES PARTICULARLY ARIZONA. ALTHOUGH THESE BOUNDARIES MIGHT BE EXPANDING. SO WE -- IT IS A HIGH PRIORITY TO FUND EFFORTS, BASIC RESEARCH EFFORTS THAT MIGHT LEAD TO UNDERSTANDING THE PROTECTIVE IMMUNE RESPONSE TO THIS -- INFECTION WITH THIS ORGANISM AS WELL AS THEN BUILD ON THAT TO DEVELOP THE VACCINE. SO WE PUBLISHED A STRATEGIC PLAN OUTLINING OUR EFFORTS THAT IN OUR COMMITMENT OVER UM COMING YEARS TO TRY TO DO THAT. NEXT SLIDE PLEASE. WE DID NOT FUND THE STUDY, THE GLOBAL RESEARCH ON ANTIMICROBIAL RESISTANCE PROJECT BUT THIS WAS A REALLY PROFOUND PUBLICATION EARLIER IN 2022 THAT ATTEMPTED TO ANALYZE THE IMPACT OF RESISTANT BACTERIAL INFECTIONS GLOBALLY AND THE EFFECT THEY HAVE ON HUMAN HEALTH. THE DATA THEY COLLECTED NOT PERFECT ESPECIALLY FROM LOW AND MIDDLE INCOME SETTINGS BUT ESTIMATED THE DEATH ATTRIBUTABLE TO RESISTANT BACTERIA ARE GREATER THAN HIV AND MALARIA. SEPARATELY AND THE SAME AS THOSE TWO COMBINED. SO H IS A SIGNIFICANT PROBLEM AND DMID AS THE EXTRAMURAL DIVISION RESPONSIBLE FOR THIS WE HAVE A LARGE ROLE TO PLAY IN FUNDING BASIC AND TRANSLATIONAL AND CLINICAL RESEARCH THAT WOULD ADDRESS THIS PROBLEM AND TRY TO MITIGATE THE IMPACT OF THESE MICROBES BECOMING RESISTANT AND HAVING THIS HEALTH IMPACT. MOST OF MY HIGHLIGHTS RESEARCH HIGHLIGHTS I'M DOING ARE RELATED TO WHAT WE HAVE DONE ON THE ANTIMICROBIAL RESISTANCE FRONT. NEXT SLIDE PLEASE. SINCE WE LAST MET, THE OVERCOME TRIAL RESULTS WERE PUBLISHED, THIS WAS TRIAL THAT TOOK YEARS AND WAS CONDUCTED IN MANY SITES INTERNATIONALLY, THIS WAS A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY THAT TESTED IN PEOPLE INFECTED WITH HIGH THROUGH RESISTANT GRAM NEGATIVE PATHOGENS, EITHER USE OF COLISTIN ALONE OR COLISTIN PLUS CARBAPENEM. THIS STUDY SHOWED THE ADDITION OF CARBAPENUM DIDN'T DERIVE BENEFIT BUT DID DRIVE RESISTANCE SO WE THINK THIS WILL CONTRIBUTE TO ESTABLISHING PRACTICE STANDARDS FOR INFECTIONS IN THE FUTURE. PREFERRED OVER DOUBLE COVERAGE. NEXT SLIDE PLEASE. WE HAVE ALSO YOU PROBABLY HEARD PAST YEARS THESE REPORTS OF MIRACLE CURES WITH BACTERIA PHAGE THERAPY, LARGELY CASE REPORTS AND PEOPLE THAT HAD SERIOUS RESISTANT INFECTIONS IN SOME CASES. SINCE THE LAST TIME WE MET, WE WERE ABLE THROUGH OUR ANTIBACTERIAL RESISTANCE LEADERSHIP GROUP TO LAUNCH A TRIAL THAT WILL TEST THE USE OF PHAGE IN ONE PARTICULAR POPULATION THAT IS LIKELY TO HAVE PROBLEMS RELATED TO RESISTANT GRAM NEGATIVE INFECTIONS. PEOPLE LIVING WITH CYSTIC FIBROSIS. SO IN THIS PHASE 1B PHASE 2 TRIAL, THERE WILL BE AN INTRAVENOUS PHAGE COKE UNTIL INFUSE, PHAGE TARGET PSEUDOMOW IN THIS ORIGIN KNOWSIS. WE ENROLL 17 PATIENTS IN 14 CENTERS STARTING IN SEPTEMBER. THE OBJECTIVES ON THE SLIDE, SAFETY, MICROBIOLOGIC ACTIVITY IN TERMS OF COLONY COUNTS, IN THE LUNGS OF PSEUDOMONUS ORIGINOSA. WE THINK IT IS IMPORTANT TO STUDY PHAGE INTERVENTION SYSTEMATICALLY, IN THE CASE REPORTS ARE GREAT BUT WE NEED A SYSTEMATICALLY CONDUCT TRIALS THAT WILL HELP US -- HELP FINISH USE PHAGE APPROPRIATELY AND ALLOW COMPANIES TO DEVELOP PHAGE COCKTAILS THAT WOULD BE MOST USEFUL FOR COMBATING ANTIMICROBIAL RESISTANCE. NEXT SLIDE PLEASE. ANOTHER TRIAL RESULT FROM THE ARLG RECENTLY PUBLISHED WAS COMBINED TRIAL, AGAIN THIS WAS A PHASE 1 TRIAL THAT EVALUATED THE SAFETY AND PHARMACO KINETICS OF USING CEFTAZIDIME IN HEALTHY VOLUNTEERS BUT A COMBINATION THAT MIGHT BE USED IN PEOPLE WHO HAVE SERIOUS AND HIGHLY RESISTANT GRAM NEGATIVE INFECTIONS SO DOUBLE COVERAGE FOR RESISTING GRAM NEGATIVE INFECTIONS. THE RESULTS SUGGESTED THAT THE TWO DRUGS CAN BE USED IN COMBINATION, THEY TESTED A VARIETY OF DOSES AND INTERMITTENT VERSUS CONTINUOUS DOSING. THEY FOUND THAT IN ONE PARTICULAR CASE, IT WAS CONTINUOUS DOSING AT THE HIGHER DOSE OF CAREFUL MONITORING OF LIVER FUNCTION TESTS REQUIRED BUT IT WAS GENERALLY SAFE. NEXT SLIDE PLEASE. SO NOW WE ARE TO THE POINT IN MY REMARKS WHERE I WILL PRESENT SBIR CONTRACT TOPICS WE DO THIS EVERY YEAR, SMALL BUSINESS THERE IS A CERTAIN PARTICULAR SPECIFIC NUMBER OF DOLLARS EACH YEAR THAT THE NIH IS REQUIRED TO PUT TOWARDS SMALL BUSINESSES. SO WE CALL FOR SPECIFIC SOLICITATION FOR SPECIFIC TOPICS THROUGH THE CONTRACT MECHANISM EVERY YEAR, SBIR GRANTS SUBMISSIONS ARE RECEIVED CONTINUOUSLY THROUGHOUT THE FUNDING YEAR. TOPIC ONE FOR DMID WOULD BE DEVELOPMENT OF BACTERIA PHAGE FOR TREATMENT OF BACTERIAL INFECTIONS. SOME MIRACULOUS CASE REPORTS OF CURES, WITH PHAGE, SOME OF THOSE PATIENTS SUFFERED FROM NON-MICROBACTERIAL INFECTIONS SO WE THINK IT IS IMPORTANT TO SUPPORT THE COMMUNITY IN MOVING FORWARD WITH THIS AS A POSSIBLE INTERVENTION, THERE'S NOT MICROBACTERIAL THERAPEUTIC PRODUCTS IN COMMERCIAL DEVELOPMENT AT THIS TIME AND WE CALLED FOR APPLICATIONS THAT WERE SUPPORT PRE-CLINICAL RESEARCH IN DEVELOPMENT OF THESE PHAGE PRODUCTS THAT MIGHT TARGET MICROBACTERIAL THAT INFECT PEOPLE CLINICALLY. NEXT SLIDE PLEASE. COPY NUMBER 2, WOULD BE NOVEL DIAGNOSTIC BIOMARKER DISCOVERY AND VALIDATION FOR MALARIA AND FOR SELECT NON-NEGLECTED TROPICAL DISEASES. T SO A NUMBER OF DISEASES CURRENTLY HAVE DIAGNOSTICS IN USE, BOTH MALARIA AND SPECIFIC NTDs BUT THEY DON'T MEET SENSITIVITY OR SPECIFICITY THRESHOLDS REQUIRED TO ACHIEVE ELIMINATION GOALS. SO WE WEREN'T PRODUCT DEVELOPMENT TO SUPPORT TO DEVELOP BETTER ONES WE THINK GENOMIC PROTEOMIC PERHAPS METABOLOMIC OR BIOINFORMATIC APPROACHES MIGHT BE USEFUL IN IDENTIFYING AND CHARACTERIZING NOVEL MALARIA OR NTB BIOMARKERS IN CLINICAL SPECIMENS.MENT SO THAT IS TOPIC 3 NO TOPIC 2. TOPIC 3 WOULD BE TO CALL FOR APPLICATIONS TO DEVELOP ALTERNATIVES TO BENDAZINE PENICILLIN FOR TREATMENT OF SYPHILIS. IT IS CURRENTLY THE ONLY -- THE RECOMMENDED THERAPY FOR TREATMENT OF SYPHILIS BUT IT IS NOT AVAILABLE ORALLY AND THERE'S LIMITED FACILITIES THAT MANUFACTURE IT. SO THE SUPPLY CHAIN IS DISRUPTED AND IT IS NOT UNCOMMON SHORTAGES OF BENZATHINE PENICILLIN WHICH CONSTRAINS THE INDIVIDUALS TO INHIBIT THE SPREAD OF SYPHILIS. IN ADDITION TO THAT, BY INJECTION SO THAT THAT LOWER LEVEL FACILITIES ARE PEOPLE THAT AREN'T CLINICALLY TRAINED, IT IS IMPOSSIBLE TO DELIVER SYPHILIS THERAPY IN THE FIELD. SO THIS WOULD SUPPORT PRE-CLINICAL DEVELOPMENT OF LEAD CANDIDATES FOR SYPHILIS OR REPURPOSE EXISTING ANTIBIOTIC DRUGS THAT MIGHT BE SUITABLE FOR SYPHILIS TREATMENT. THAT IS OR THIRD CONTRACT TOPIC. THE LAST PROPOSED CONTRACT TOPIC IS THE DEVELOPMENT OF SEROLOGIC TEST FOR HERPES SIMPLEX TYPES 1 AND 2 INFECTION. THIS IS SIGNIFICANT BECAUSE A LOT OF PEOPLE WHO SURF FROM MORE INFECTED WITH GENITAL HERPES, HERPES TYPE 1 OR TWO OR ASYMPTOMATIC 5:A SEROLOGIC TEST IS USED TO CONFIRM INFECTION BUT THE COMMERCIALLY AVAILABLE SEROLOGIC TEST FOR HSV 1 AND 2 HAVE HIGH FALSE POSITIVE RATES SO THEY AREN'T ENDORSED FOR POPULATION LEVEL SCREENING. SO WE PROPOSE DEVELOPERS COME UP WITH A BETTER SEROLOGIC TEST FOR GENITAL HERPES THAT RETAINS HIGH SPECIFICITY AND SENSITIVITY AND GOOD POSITIVE PREDICTIVE VALUE THAT COULD DISTINGUISH BETWEEN HSV 1 AND 2. AND USE TECHNOLOGIES SUCH AS THAT FOR A TEST THAT COULD BE DISTRIBUTED FOR BROAD USE. RIGHT NOW THERE IS A WESTERN BLOT TEST DONE AT ONE ACADEMIC INSTITUTION IN THE NORTHWEST OF THE UNITED STATES BUT IT IS NOT WIDELY AVAILABLE COMMERCIALLY AND WE THINK THAT THIS COULD BE DONE BETTER, SO YES PROPOSE THIS CONTRACT SOLICITATION FOR A BETTER TEST FOR HSV 1 AND 2. THAT IS MY LAST SLIDE SO I WOULD ASK YOU, ANY QUESTIONS ON THE SBIR CONTRACT TOPICS? I WOULD ASK YOU TO VOTE ON THEM AND ADD ANY COMMENTS TO PROGRAM YOU MIGHT IN YOUR ELECTRONIC COUNCIL BOOKS. SO THE NEXT EYE TESTIMONY ON THE AGENDA IS DR. LEE SHONDRA PRICE WHO WILL TALK ABOUT NIAID'S TRAINING PROGRAMS. I SEE YOU ARE HERE. AND I THINK WE HAVE -- I DON'T KNOW WHO IS MOVING YOUR SLIDES. ARE THEY GOING TO PROJECT THEM? >>YES, JULIO SAID HE WOULD DO IT FOR ME. THANK YOU SO MUCH AND IT IS GREAT, A PLEASURE TO BE WITH Y'ALL THIS AFTERNOON. WE CAN GO TO THE NEXT SLIDE PLEASE I'M EXCITED TO SHARE INFORMATION ABOUT OUR TRAINING PORTFOLIO, SPECIFICALLY IN REFERENCE TO THE GOALS OUR INSTITUTES SET FOR TRAINING IN 2019. SO YOU CAN THINK OF THIS AS A LITTLE BIT OF AN UPDATE. I WILL ALSO HIGHLIGHT A NEW FUNDING OPPORTUNITY THAT WAS RECENTLY RELEASED. NEXT SLIDE PLEASE. SO IN 2019 AFTER REVIEW OF THE INSTITUTE TRAINING PORTFOLIO, FOUR SPECIFIC RECOMMENDATIONS WERE SET OUT FOR TRAINING THAT WOULD BE IMPLEMENTED OVER FIVE YEARS. FIRST THE MAIN GOAL WAS TO INCREASE THE EXTRAMURAL TRAINING BUDGET BY APPROXIMATELY $13 MILLION OVER THE FIVE YEAR PERIOD. ADDITIONAL GOALS ARE DECREASE INSTITUTIONAL TRAINING T 32 BUDGET, INCREASE SUPPORT FOR FELLOWS, BY INCREASING INVESTMENT IN THE NRSA FELLOWSHIPS. AND INCREASE THE SUPPORT FOR CAREER AWARDS. DATA I'LL PRESENT TODAY IS THROUGH FISCAL YEAR 21, OUR ANALYSES ARE NOT YET COMPLETE FOR FY 22. NEXT SLIDE PLEASE. WE INCREMENTALLY PROVIDED ADDITIONAL FUNDS TO OUR BUDGET FOR TRAINING AND AS OF FY 21 WE EXCEEDED THE GOAL INCREASING THE PORTFOLIO BY 13 MILLION. THE INSTITUTE REMAINS COMMITTED TO SUPPORT FOR TRAINING, ACCORDING TO OUR RECENT PRELIMINARY INFORMATION OF OUR FY 22 ANALYSES, WE INCREASED THE BUDGET BY APPROXIMATELY ANOTHER $5 MILLION FOR TOTAL PORTFOLIO OF FTs AND CRICKs FOR AROUND $124.5 MILLION. WE HAVE BEEN HOLDING FAIRLY STEADY AS YOU CAN SEE OVER THE LAST FEW YEARS IN TERMS OF PERCENTAGE OF THE BUDGET DEVOTED TO Fs, Ts AND Ks. NEXT SLIDE PLEASE. OVER TIME LIMITING THE NUMBER OF SLOTS FOR OUR T 32 HAS RESULTED IN A REDUCTION OF HOW MUCH WE SPENT ON T 32s. SO THE LAST SLIDE SHOWED THAT THE OUTSIDE OF THE RECOMMENDATIONS APPROXIMATELY 48% OF THE NIAID TRAINING BUDGET WAS SPENT ON T 32s. NOW THAT AMOUNT IS ROUGHLY 44%. . DESPITE REDUCTION IN SLOTS, WE WANT TO MAKE SURE THAT THE PROGRAMS WE SUPPORT ARE STILL RIGOROUS AND CONTINUE TO PROVIDE TRAININGS WITH OPPORTUNITIES THAT PUT THEM INTO CUTTING EDGE OF SCIENCE. THEREFORE WE IMPLEMENTED SEVERAL OTHER ACTIONS TO SUPPORT OUR INSTITUTIONAL TRAINING PROGRAMS. SUCH AS ADDITION OF TWO DE NOVO T 32s EACH YEAR, TO COME BAD STAGNATION IN OUR PROGRAMS AND ANNUAL REVIEW OF THE INSTITUTIONS WITH MULTIPLE T 32s TO ENSURE THAT THEY ARE FILLING AN UNMET TRAINING NEED NOT ALREADY COVERED BY EXISTING PROGRAMS. NEXT SLIDE PLEASE. TAKING A CLOSER LOOK AT THE Ts, OVERALL THE SUCCESS RATES HAVE BEEN STRONG FOR THE Ts. AT ROUGHLY 53 TO 61% THE PAST FEW YEARS. THERE WAS A LITTLE BIT OF DIP IN FY 21 WHEN WE SAW INCREASE IN UM NUMBER OF APPLICATIONS. BUT WE HAVEN'T SEEN ANY SIGNS THAT ANY REAL SIGNS THE PLIMMATION ON SLOTS IS IMPEDING APPLICATIONS. WE ALSO HAVE SUPPORTED A GOOD NUMBER OF NEW PROGRAMS. ON THE RIGHT YOU WILL SEE THE DE NOVO, YOU WILL SEE THE TYPE ONE AWARDS AND -- THAT WERE COMPLETE -- THE DE NOVO AWARDS, SO WITH THE EXCEPTION OF ONE AWARD IN FISCAL YEAR 19 AND ONE AWARD IN FISCAL YEAR 20 THAT WERE COMPLETE REVAMPS OF FORMER PROGRAMS THAT WERE STRUGGLING ALL OF THE OTHER PROGRAMS REPRESENTED HERE ARE DE NOVO PROGRAMS. WITHIN THE GROUP OF AWARDS THERE IS A NICE MIX OF PROGRAMS INSTITUTIONS WITH EXISTING NIAID T 32s BUT UNIQUELY DISTINCT AND ALSO INSTITUTIONS THAT HAVE HAD NO PRIOR T 32s. WITH RESPECT TO THE THIRD GOAL INCREASING THE F BUDGET WE HAVE NOT SEEN THE PROGRESS WE EXPECTED TO SEE. TWO MAJOR AREAS WERE HIGHLIGHTED FOR IMPROVEMENT IN THE F BUDGET. FIRST TO INCREASE THE RATE FOR 25% TO F 32s, THE POST-DOCTORAL AWARDS AND SUCCESS RATE STAGNATED AROUND 13 TO 16%, WE HAVE NOT SEEN IMPROVEMENT THROW FY 21. THE SECOND MAJOR FOR IMPROVEMENT WAS ACHIEVE TOTAL OF 25 AWARDS ANNUALLY FOR THE DIVERSITY F 31, WE ARE MAKING PROGRESS. SO LOOKING MORE CLOSELY, AT THE DATA FOR ALL OUR FOLLOW SHIPS THE OVERALL SUCCESS RATES FOR Fs ARE LOW, COVERING MOSTLY IN THE TEENS, AND APPLICATION NUMBERS ARE STAYING CONSTANT WITH RECENT INCREASE IN FY 21 BUT AWARD NUMBERS INCREASING. FY 19 WAS PEAK FOR SUCCESS RATES, MAINLY DUE TO INCREASE IN THE OVERALL NUMBER OF AWARDS. SO WE HAD A YEAR WITH MORE F AWARDS THAT YEAR AND MAYBE UPWARD TRAJECTORY BUT WE NEED TO MONITOR CLOSELY TO ENSURE THE TREND CONTINUES. WHEN WE LOOK MORE CLOSELY DISAGGREGATING BY MECHANISM WE SEE THE F 32 POST-DOCTORAL AWARDS HAVE SUCCESS RATES IN TEENS. OUR EXPECTATION WAS THAT WITH INCREASE IN THE F BUDGET WE SEE INCREASES IN THIS OUR SUCCESS RATES. WE KNOW THIS IS A IMPACTFUL PROGRAM FOR NIAID WITH MOST OF OUR AWARDEES APPLYING FOR RO1 EQUIVALENT AWARD, ROUGHLY HALF RECEIVING SUCH AN AWARD WE HAVE BEEN SUCCESSFUL IN THIS SPACE. BUT WE WANT THIS SUCCESS TO EXTEND TO MORE EARLY CAREER RESEARCHERS. NOW WHEN WE LOOK AT THE F 31,S FROM DOCTORAL AWARDS BOTH DIVERSITY FOCUSED PROGRAM AND STANDARD PROGRAM, DIVERSITY EQUITY AWARS ARE ON A POSITIVE TRAJECTORY. AWARD MEMBERS ARE INCREASING ANNUALLY AND WHILE WE ARE STEADILY WORKING UP TO OUR GOAL OF 25 AWARDS PER YEAR FOR THE DIVERSITY F 31 WE NEED TO MAKE SURE THAT GOAL IS COMMENSURATE WITH THE NEEDS OF THE COMMUNITY. WE WILL CONTINUE TO MONITOR THIS PROGRAM CLOSELY TO MAKE SURE THAT WE ADJUST OUR AWARD GOALS, SHOW THE APPLICATION NUMBERS AND SUCCESS RATES CONTINUING TO RISE. WHILE NOT A TARGET GOAL OF OUR PORTFOLIO INITIALLY IN FY 19, WE ARE STILL MONITORING OUR OTHER NRSA FELLOWSHIPS LIKE THE PARENT F 31 PROGRAM WE RECEIVED SIGNIFICANTLY MORE F 31 PARENT APPLICATIONS THAN WE DO DIVERSITY F 31s BUT THE SUCCESS RATES OF THE PARENT PROGRAM ARE LOWER. WHILE WE ARE ON TRACK TO SUPPORT OUR DIVERSITY APPLICANTS, WE NEED TO MAKE SURE THAT WE ARE NOT LEAVING THE PARENT PROGRAM TOO FAR BEHIND PARTICULARLY WITH OUR SUCCESS RATES HOVERING AROUND 10% AND WITH THE ADVOCATION NUMBERS ON THE RISE SO WE WILL CONTINUE TO MONITOR THIS SITUATION. FINALLY WE HAVE DUAL DEGREE PRE-DOCTORAL PROGRAM THE F 30. THIS PROGRAM REMAINED RELATIVELY STABLE THE LAST FIVE YEARS WITH SUCCESS RATES HIGHER THAN THE OTHER PROGRAMS FOR MOST FISCAL YEARS. WITH THIS PROGRAM BEING EARLY STAGE PHYSICIAN SCIENTIST PROGRAM WE NEED TO MAKE SURE WE ARE PROVIDING ADEQUATE SUPPORT TO THE F 30 APPLICANTS AS WELL DESPITE THIS PROGRAM NOT ACTUALLY BEING ONE OF OUR ORIGINAL FY 19 GOALS. THE FOURTH GOAL WHICH WAS TO INCREASE THE K BUDGET WAS DIVIDED TO THREE MAYOR AREAS OF IMPROVEMENT. SIMILAR TO THE APPS WE HAVE HAD SOME SUCCESS FOR Ks BUT STILL HAVE MORE WORK TO DO. THE FIRST AREA OF IMPROVEMENT WAS TO INCREASE THE NUMBER OF K99 AWARDS TO 12 AWARDS UP FROM 6 IN FY 18. WE HAVE MADE SOLID PROGRESS HERE WITH 13 AWARDS IN FY 21 AND AS WITH DIVERSITY F 31s WE NEED TO CONTINUE MONITORING THE K99s TO ENSURE WE REMAIN ON TRACK. THE SECOND AREA OF NEED WAS THE K 22 AWARD, THE GOAL WAS SET TO FUND 20 UP FROM 14 IN FY 18. WE ARE NOT QUITE THERE YET. WE ARE STILL HOVERING IN THE MID-TEENS. NEXT. THE FINAL AREA OF IMPROVEMENT WAS FOR THIS GOAL WAS TO ACHIEVE A SUCCESS RATE OF 35% FOR OUR OTHER MAIN K PROGRAMS INCLUDING THE KO 1, K 08, K 23, 24 AND 25. IN FY 20 WE WERE 40% AND FY 20, 40% SUCCESS RATE AND FY 21, 42%. WE EXPERIENCE SUCCESS HERE AND WE ARE CONTINUING TO MONITOR THIS SITUATION TO ENSURE THAT WE MAINTAIN THESE SUCCESS RATES IN THE FUTURE. SO WE HAD SOME SUCCESSES WITH OUR Ks BUT WE STILL HAVE MORE WORK TO DO. NEXT SLIDE PLEASE. ENHANCING DIVERSITY REMAINS ONE OF NIH'S TOP PRIORITIES AND IT IS A PRIORITY FOR NIAID ALSO. IN MAY I PRESENT AD CONCEPT CLEARANCE FOR NEW FUNDING OPPORTUNITY ANNOUNCEMENT TO SUPPORT RO1 FUNDING TO RESEARCHERS FROM DIVERSE BACKGROUNDS INCLUDING INVESTIGATORS FROM UNDER-REPRESENTED RACIAL ETHNIC GROUPS WITHIN ALL OF NIAID MISSION AREAS. SPECIFICALLY THIS INITIATIVE, THIS NEW INITIATIVE SUPPORTS NEW INVESTIGATORS EARLY STAGE INVESTIGATORS AND AT RISK INVESTIGATORS FROM DIVERSE BACKGROUNDS AS DEFINED BY THE NIH INTEREST IN DIVERSITY. I'M SURE YOU ARE FULLY ACQUAINTED WITH THE DEFINITION OF NEW AND EARLY STAGE INVESTIGATORS BUT YOU MAY NOT BE AS FAMILIAR WITH THE TERM AT RISK INVESTIGATORS. AND THE AT RISK INVESTIGATORS ARE THOSE WHO HAD PRIOR SUPPORT AS PIs ON SUBSTANTIAL RESEARCH AWARD AND LESS SUCCESSFUL IN SECURING A SUBSTANTIAL RESEARCH AWARD IN THE CURRENT FISCAL YEAR WILL HAVE NO SUBSTANTIAL RESEARCH GRANT FUNDING IN THE FOLLOWING FISCAL YEAR. SO THIS IS A UNIQUE OPPORTUNITY THAT PROVIDES OPPORTUNITIES FOR AWARDEES TO PARTICIPATE NOT ONLY IN THIS PARTICULAR NEW OPPORTUNITY NEW GRANT FUNDING OPPORTUNITY BUT THE OPPORTUNITY ALSO COMES WITH NETWORKING COLLABORATION MENTORSHIP AND CAREER DEVELOPMENT. SO EACH YEAR EVERY PERIODICALLY THERE WILL BE OPPORTUNITIES FOR AWARDEES TO PARTICIPATE WITH US HERE AT NIAID IN -- AND WITH OR COLLABORATIVE ICs IN PARTICULARLY SPECIFIC MEETINGS AND WORKSHOPS TO CONTINUE THEIR CAREER DEVELOPMENT. SO WE INTEND TO SUPPORT APPROXIMATELY 15 TO 25 AWARDS FOR FISCAL YEAR DEPENDING ON AMOUNT AND PENDING AVAILABILITY OF FUNDS AND SUBMISSION OF SUFFICIENT NUMBER OF MER ORIUS APPLICATIONS. THE FOA WAS RELEASED SEPTEMBER 21ST, 2022 AND FIRST SUBMISSION DATE WAS IN DECEMBER. WE RECEIVED 66 APPLICATIONS THAT WILL BE REVIEWED THIS SPRING SO COUPLE HAVE ALREADY BEEN REVIEWED IN THE LAST COUPLE OF WEEKS, THE REST WILL BE REVIEWED IN FEBRUARY AND MARCH AND THEY WILL GO TO MAY COUNCIL. SO WE ARE VERY EXCITED ABOUT THIS -- WHAT WE CALL THE DIVERSITY RO1. WE ARE EXCITED ABOUT THIS FUNDING OPPORTUNITY ANNOUNCEMENT AND WE ENCOURAGE ALL ELIGIBLE TO APPLY. PLEASE SPREAD THE WORD. NEXT SLIDE. BRIEFLY I WANT TO MENTION SOME TRAINING RESOURCES WHICH RECENTLY UPDATED ON THE RIGHT WE WILL SEE WE HAVE TWO UPDATED TRAINING HAND OUTS. ONE FOR MDs AND ONE FOR Ph.D.s. WE ARE IN THE PROCESS OF FINALIZING A THIRD HAND OUT FOR DIVERSITY SPECIFIC OPPORTUNITIES. WE ALSO HAVE INCREDIBLY ROBUST NIAID TRAINING HOME PAGE, I WANT TO MAKE SURE YOU ARE AWARE OF THAT AND SHARE INFORMATION ABOUT OUR WEB PAGE AS WELL. WE OFFER SAMPLE F AND K APPLICATIONSEN OUR WEB PAGE, SAMPLE APPLICATIONS. OF COURSE THE AI TRAINING HELP DESK EMAIL BOX IS A RESOURCE FOR DIRECT COMMUNICATION WITH INDIVIDUALS IN OUR OFFICE. NEXT SLIDE PLEASE. WHAT ARE FUTURE PLANS, SO LOOKING FORWARD OUR NEXT STEPS INCLUDE CONTINUED EXAMINATION AND ANALYSIS OF THE PORTFOLIO. INCLUDING OUR FY 22 DATA. MENTAL HEALTH IS IDENTIFIED IF WE HAVE MADE PROGRESS ON OUR GOALS THAT WERE LAGGING BEHIND AND ALSO HELP US TO MAKE SURE WE ARE AT LEAST MAINTAINING THE HEADWAY WE MADE ON THE GOALS WHERE WE HAVE SEEN ADVANCES. WE ALSO PLAN TO DO DEEPER DIVE TO SEE IF THERE ARE ANY ADDITIONAL GAPS IN OUR PORTFOLIO. BASED ON THE DATA WE HAVE SO FAR, WE DO PLAN TO ENHANCE EFFORTS TO INCREASE THE NUMBER OF F AWARDS, FELLOWSHIPS ACROSS THE BOARD, F 30, F 31, F 32, TO MEET GOALS SET IN 2019. ALSO TO MAKE MORE CONCERTED EFFORT TO INCREASE THE NUMBER OF K 22s TO MEET OUR GOAL OF 20 PER YEAR. WHILE I ONLY BRIEFLY MENTION SCIENTIFIC WORK FORCE DIVERSITY TODAY THIS IS A TOPIC THAT IS ON THE INSTITUTE'S RADAR, OUR OFFICE PARTNERS WITH NIAID DIVERSITY COUNCIL, WE MONITOR PROGRESS WITH THE UNITE INITIATIVE TO IDENTIFY STRATEGIC OPPORTUNITIES TO ENHANCE SCIENTIFIC WORK FORCE DIVERSITY. WE ARE VERY EXCITED TO SEE THE OUTCOME OF OUR FIRST DIVERSITY RO1 APPLICATIONS AND WE ARE LOOKING FOR MORE OPPORTUNITIES IN THIS SPACE. NEXT SLIDE PLEASE. WITH THAT, I WILL OPEN UP FOR DISCUSSION. I APPRECIATE THIS OPPORTUNITY TO SHARE THIS UPDATE WITH YOU AND I LOOK FORWARD TO HEARING FROM YOU. THANKS SO MUCH. >>THANK YOU, LASHANDRA. ANY QUESTIONS FROM HOE THAT WAS A REALLY FAST OVERVIEW. THERE IS A LOT OF MATERIAL THERE. DOES ANYBODY WANT TO MAKE COMMENTS OR QUESTIONS? I SEE A HAND FROM MARY ESTES. >>THANK YOU VERY MUCH FOR THE INTERESTING PRESENTATION. SO YOU SAID IF YOU HADN'T MET YOUR GOALS, WAS THAT BECAUSE THERE WEREN'T ENOUGH APPLICATIONS SUBMITTED OR THE QUALITY WASN'T HIGH ENOUGH OR ANOTHER REASON? >>I THINK WE -- SO THE PERIOD OF TIME IS A TOTAL OF FIVE YEARS, WE ARE NOT AT THE END OF THE FIVE YEARS YET. WE ARE STILL WORKING ON IMPROVING THE SUCCESS RATE IN THE AREAS WE HAVE NOT QUITE YET MET OUR GOALS. I THINK THAT THERE ARE MANY DIFFERENT REASONS FOR WHY WE HAVEN'T MET GOALS FOR PARTICULAR ANNOUNCEMENTS WITH THE -- WITH OUR FELLOWSHIPS, EARLY CAREER VERY EARLY CAREER STUDENTS, MOSTLY GRADUATE STUDENTS, POST DOCS THERE ARE NUMBER OF THINGS THEY PROBABLY CAN DO LALE BIT BETTER IN TERMS OF GRANT WRITING EXPERIENCE. ONE OF THE THINGS THAT YOU ARE OUR OFFICE IS PLANNING TO DO IS OFFER A FREE SERIES OF WORKSHOPS VIRTUAL WORKSHOPS FOR ANYONE THAT WANTS TO ATTEND ABOUT GRANTSMANSHIP KINDS OF ACTIVITIES AND HOW TO DO A BETTER JOB AND EVEN A BETTER -- HAVING A BETTER UNDERSTANDING OF THE FUNDING PROCESS. ONE OF THE THINGS IN MY PAST EXPERIENCE HERE AT NIH IS WE KNOW WHEN PEOPLE HAVE A BETTER UNDERSTANDING OF THE PROCESS THEY TEND TO WRITE APPLICATIONS IN A DIFFERENT WAY, THEY THINK AND VISUALIZE THEIR SCIENCE DIFFERENTLY. THAT CAN CONTRIBUTE TO SEEING BETTER SUCCESS ALONG THE WAY. SO I WOULD SAY IT IS NOT ONE THING, WE ARE NOT QUITE THERE YET BUT THERE ARE NUMBER OF DIFFERENT CONTRIBUTORS TO WHY WE HAVEN'T QUITE MET THE GOALS WE SET OUT SO FAR. >>I THINK HARRY GREENBERG HAS HIS HAND UP. YOU ARE ON MUTE. >>ON MUTE. MY WIFE THINKS THAT IS GOOD. ANY CASE SOUNDS LIKE NIAID IS DOING A GREAT JOB. IS THERE A SITE WHERE THE NIH HAS COMBINED ALL THE INSTITUTES EFFORTS ESPECIALLY IN DEI IN YOUNG PEOPLE ENTERING ACADEMIC MEDICINE WHERE YOU CAN SORT OF SEE THE TOTAL, JUST THINKING ABOUT WHERE I AM AS A WHOLE IS THERE A PLACE WE CAN FOCUS AND RATHER INSTITUTE BY INSTITUTE LET ALL OF OUR FACULTY KNOW HERE IS ALL THE RESOURCES IN THIS AREA AND YOU SHOULD TAKE ADVANTAGE OF IT IN TRAINING ACTIVITIES SPECIFIC TO YOUR AREA. >>TO MY KNOWLEDGE THERE IS NOT SUCH A SITE ON THE NIH WEBSITE. I WILL CHECK WITH THE CHIEF OFFICER FOR SCIENTIFIC WORK FORCE DIVERSITY, DR. VALENTINE AND HER STAFF TO SEE IF THAT IS SOMETHING THEY HAVE PLANNED. THERE IS OF COURSE A UNITE WEBSITE AND THERE IS A WEBSITE ON THE COMMON FUND THAT HAS A FEW DIVERSITY-RELATED FUNDING OPPORTUNITY ANNOUNCEMENTS BUT I DON'T THINK THERE IS A SINGLE WEBSITE FOR ALL OF NIH WHERE ONE CAN GO LOOK FOR THIS INFORMATION. I THINK THAT IS A FANTASTIC IDEA, I WILL FOLLOW-UP WITH THEM ON THAT. >>IT WOULD BE REALLY HELPFUL AT LEAST FOR US. >>THANKS SO MUCH FOR THAT GREAT IDEA. >>ANY OTHER QUESTIONS OR COMMENTS FOR LASHAWNDRA? OKAY. THANK YOU SO MUCH, LASHAWNDRA. YOU ARE ALWAYS WELCOME TO. COBACK IN THE ENOUGH TIME WE CAN ASSESS PROGRESS, BUT THANK YOU FOR GIVING US THAT OVERVIEW. APPRECIATED. >>THANK YOU. MY PLEASURE. >>OKAY. SO I THINK WE CAN MOVE FORWARD IN THE DMID AGENDA. WE HAVE FIVE CONCEPTS FOR -- TO PRESENT FOR CLEARANCE WHICH MEANS YOU VOTE IN THE ELECTRONIC COUNCIL RECORD AND ALSO HAVE AN OPPORTUNITY TO ADD IN COMMENTS ON HOW WE MIGHT -- COMMENTS WE CONSIDER FOR IMPROVING INITIATIVE AS IT WAS PRESENTED. I THINK OUR FIRST PRESENTER IS MARIA (INDISCERNIBLE) SHE CAN PRONOUNCE HER OWN NAME SINCE I MIGHT HAVE GOTTEN IT WRONG. MARIA. ARE YOU THERE? >>I'M HERE. WIRIYA? >>VERY CLOSE, YES. HI. GOOD AFTERNOON, EVERYONE, I'M WIRIYA, PROGRAM OFFICER FROM THE GENOMICS ADVANCE DIVISION OF MICROBIOLOGY AND INFECT SHIES DISEASE. HERE TO PRESENT THE CONCEPT FOR THE BRC FOR INFECTIOUS DISEASES. NEXT SLIDE PLEASE. THE OBJECTIVE OF THE INITIATIVE IS TO CONTINUE SUPPORT FOR THE RESOURCE CENTER WHICH PRODUCT LEVEL PLATFORMS FOR THE INFECTIOUS DISEASE RESEARCH COMMUNITY. THE OBJECTIVES INCLUDE TO CONTINUE PROVIDING THE COMMUNITY WITH AN INTEGRATED KNOWLEDGE BASE THAT HARMONIZES DATA TO BASIC APPLIED INFECTIOUS DISEASE RESEARCH. WE ALSO WANT TO CONTINUE ADVANCING INNOVATIVE TECHNOLOGIES, PROVIDE INFORMATIC IN PUBLIC HEALTH EMERGENCIES. THE PROPOSED MECHANISM IS A U 24 CO-OPERATIVE AGREEMENT FOR RESOURCES. WE ANTICIPATE MAKING ONE TO TWO AWARDS WITH A TOTAL BUDGET OF 9 MILLION IN THE FIRST YEAR NEXT SLIDE PLEASE. THIS SLIDE PROVIDES A SHORT HISTORY OF THE BRCs. BRCs WERE ESTABLISHED IN 2004 TO PROVIDE GENOME ASSEMBLY AND ANNOTATION SERVICES TO THE RESEARCH COMMUNITY. THEY HAVE SINCE MATURED INTO CENTERS THAT PROVIDE ACCESS TO THE DATA SETS AND TOOLS, WHILE SUPPORTING NIAID AND COMMUNITIES NEEDS DURING OUTBREAKS. THE CONTRACTS WILL INITIALLY SEPARATED BY ORGANISM AND BECAME MORE COMPLEX IN (INAUDIBLE) BUT LESS FRAGMENT AS TIME WENT BY. IN THE CURRENT ITERATION 2019, TWO CONTRACTS WERE AWARDED TO FOCUS ON TWO SETS OF BIOLOGICAL DOMAINS. THE BVBRC SUPPORT RESOURCES FOR BACTERIAL AND VIRAL FAMILIES, IS EVENTUAL INFECTIOUS DISEASES, AND (INAUDIBLE) PROVIDES RESOURCES FOR PATHOGENS AND VECTORS AND HOSTS. NEXT LIED PLEASE. THIS SLIDE PROVIDES AN OVERVIEW OF THE MAIN FOUR ELEMENTS OF THE BRCs. THE FIRST ELEMENT, THE KNOWLEDGE BASE, TAKES DATA FROM DIFFERENT PUBLIC REPOSITORY, HARMONIZES THE DATA, AND PROVIDES TOOLS THAT ALLOW INVESTIGATORS TO PERFORM MEANINGFUL DATA ANALYSIS IN A CONTEXT OF THEIR OWN SCIENTIFIC QUESTIONS. THE OTHER ELEMENTS ARE AN R&D COMPONENT TO ADVANCE BIOINFORMATIC TECHNOLOGIES SERVICES TO THE COMMUNITY AND SUPPORT TO NIAID'S PRIORITIES DOING PUBLIC HEALTH EMERGENCIES. THESE FOUR ELEMENTS MAYBE DISPLAYED THROUGH ALL MY PRESENTATION. NEXT SLIDE PLEASE I WILL PROVIDE A SAMPLE OF THE BRC KEY ACCOMPLISHMENTS IN EACH OF THE FOUR ELEMENTS IN THE AREA OF THE FIRST ELEMENT THE KNOWLEDGE BASE, THE PROGRAM IS ESTABLISHED BIOINFORMATIC RESOURCES, WITH A PORTAL OR RESEARCH WEB SITES VUEBRC, BOTH HAVE ASSEMBLED AND CARRIED OVER 10 MILLION GENOMES INCLUDING DATA WITH GENOMES SUPPORT METADATA. IN ADDITION, THERE ARE OVER THOUSANDS OF TRANSCRIPTOMIC DATA SETS AND OVER 6 BILLION GENES AND PROTEINS INCLUDING IMMUNE EPITOPES. IN ADDITION THE BRC PROVIDE VALIDATED BIOINFORMATIC TOOLS TO REVIEW, ANALYZE AND TRANSFORM DIFFERENT DATA TYPES. SOME OF THESE TOOLS ARE SHOWN HERE. THESE TOOLS AND PRIVATE WORK SPACES, RESEARCHERS CAN ANALYZE THEIR OWN DATA IN A CONTEXT OF HIGH QUALITY PUBLIC DATA, WHICH ALLOWS THEM TO ANSWER THEIR OWN RESEARCH QUESTIONS AND DISEASES. NEXT SLIDE PLEASE. IN THE AREA OF THE SECOND ELEMENT, ADVANCING INNOVATIVE TECHNOLOGIES THE BRCs CONTINUE TO MOVE AWAY FROM AUTOMATION -- TO AUTOMATION PROCESSES FOR DATA CURATION AND QUALITY CONTROL FOR THE SYSTEMS FURTHERMORE, THE VU PATH IMPROVES METHODS FOR GROUPS TO ENABLE EUKARYOTIC FUNCTIONAL ANNCATION. THE VBVRC CONTINUE TO EXPLORE AND IMPLEMENT DEEP MACHINE LEARNING TO ADVANCE PATHOGENICITY PREDICTION INCLUDING PHENOTYPE PREDICTION. FOR EXAMPLE, IN THESE RECENT PUBLICATION, VB BRC GENERATED A MODEL THAT CAN PREDICT PHENOTYPE FROM PLASMA OR CHROMOSOME AND SHOW THIS COULD BE DONE WITH HIGH ACCURACY OF PREDICTION ACROSS MULTIPLE GENR GENRE. NEXT SLIDE PLEASE. IN THE AREA OF THE THIRD ELEMENT BIOINFORMATIC SERVICES TO THE RESEARCH COMMUNITIES, BRCs, HAVE PROVIDED EXTENSIVE END TO END SUPPORT. FROM RAW DATA TO HIGH QUALITY PUBLICATION. ON THAT NOTE OVER 9 MILLION JOBS WERE SUBMITTED BY SCIENTIFIC COMMUNITY SHOW ON THE TOP RIGHT KEEP IN MIND THE GRAPH IS PLOTTED IN LOCK SCALE WITH GENOMIC ANNOTATION TOOLS IN THE MOST FREQUENTLY USED ONES BY OVER 68,000 USERS WORLDWIDE SHOW IMAGE ON THE LOWER RIGHT. BEYOND THE USAGE VRCs ROBUST OUTREACH AND TRAINING ACTIVITIES. THEY ESTABLISH OPEN FORUMS FOR THE COMMUNITY WHICH ARE HIGHLY ATTENDED FIELD AND FOLLOWED VIA MULTIPLE CHANNELS UP TO DATE CLOSE TO 30,000 PUBLICATIONS CITED BRC RESOURCES SHOWING HOW THE BRC PROGRAM HAS BEEN ENABLED SCIENCE THROUGHOUT THE YEARS. NEXT SLIDE PLEASE. IN THE AREA OF THE FOURTH ELEMENT RESPONDING TO THE PUBLIC HEALTH EMERGENCY, THE BRC PROGRAM, HAS BEEN A CRITICAL PLATFORM FOR GENOMIC ANALYSIS OF EMERGING INFECTIOUS DISEASES OVER THE PAST YEARS INCLUDING FOR H 1N 1 INFLUENZA, EBOLA VIRUS, ZIKA VIRUS, SARS COV-2, FUNGI MALARIA AND DRUG RESISTANT BACTERIA. THESE SLIDE SHOWS EXAMPLES OF THE TWO RECENT AND CONTINUING VIRAL OUTBREAKS OF SARS COV-2 AND IMPACTS. BOTH SEVERITY AND CORONA VIRUS FAMILIES HAVE BEEN PART OF THE BRC SINCE INCEPTION. AND THUS THIS PROVIDES SOLID FOUNDATION THAT COULD BE EXTENDED QUICKLY AT THE BEGINNING OF THE OUTBREAKS. DURING OUTBREAKS THE BRCs STRENGTHEN THE E RESOURCE TO ACCOMMODATE MORE DETAIL SUPPORT FOR GENOMIC EVOLUTION, PHYLOGENETIC ANALYSIS AND MAINTAIN SUPPORT, FOR EXAMPLE THE NEW RESOURCES HELP INVESTIGATORS IDENTIFY THE IMAGING VARIANTS AND HELP ASSESS HOW KEY MUTATION IMPACT RECEPTOR BINDING FOR ANTIBODY INTERACTION. SUCH DISCOVERY IS IMPORTANT PUBLICATION FOR DETECTING BROADLY DETECTED VACCINES AND OFFER COUNTER MEASURES AGAINST THE VIRAL FAMILIES. FOR THE FY 24 INITIATIVE CONCEPT OF THE BRC PROGRAM, WE WANT TO CONTINUE TO IMPROVE THE BIOINFORMATICS INFRASTRUCTURE FOR THE INFECTIOUS DISEASE COMMUNITY. WE ENVISION THAT THE PROGRAM WILL CONTINUE TO SHY NEAR USE EFFORTS AND HER AGENCY HOE OTHER AGENCIES TO SO SCOPE KNOWLEDGE BASE BUT ALSO IDENTIFY OPPORTUNITIES PARTICULARLY AT TIMES WHEN RAPID CHANGES IN THE BIOINFORMATICS LANDSCAPE. WE ALSO WOULD LIKE NEW BRCs TO DEVELOP AND INCORPORATE NEW IMAGING METHODS AND ALGORITHMS TO ANALYZE THE DATA WITH A QUICK TURN AROUND TIME INCLUDING MORE EMPHASIS ON USING MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE OR MODELS THAT CAN HELP TO ACCELERATE THE DEVELOPMENT OF DIAGNOSTICS THERAPEUTICS AND VACCINES. LASTLY, AS FOR THE CENTRAL STRUCTURE WE ENVISION SUBMITTED APPLICATIONS CAN PROPOSE STEPS OF BIOLOGICAL DOMAINS, SIMILAR TO THE CURRENT STRUCTURE THAT SEPARATE EUKARYOTIC FROM BACTERIAL VIRAL PATHOGENS BUT ALSO ENVISION A SINGLE CENTER PROPOSING TO COVER ALL BIOLOGICAL DOMAINS. NEXT SLIDE PLEASE. THE CON FIRST, THANK YOU SO MUCH FOR TAKING THE TIME TO REVIEW AND PROVIDE VALUABLE FEEDBACK BOTH COUNCIL MEMBER SUPPORT THE CONCEPT AND RECOGNIZE THAT THE BRC PROGRAM HAS LEAD IN PROCESSING AND INTEGRATING DIVERSE DATA FROM PUBLIC REPOSITORIES. THE PROGRAM IS PRODUCTIVE AND WILL POSITION TO PLEA AGREEMENT PRODUCTION LEVEL AND SUSTAINABLE KNOWLEDGE BASE THAT ADVANCE BIOINFORMATICS TECHNOLOGIES INCLUDING MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE FOR CLINICAL APPLICATION IN REAL WORLD SCENARIOS. REVIEWERS RECOMMENDED TO ENSURE BRC INTERACT AND SYNERGIZE WITH OTHER KNOWLEDGE BASES INCLUDING THOSE PROPOSE RESPONSE DATA SOME HOST RESPONSE DATA INCLUDES IN THE CURRENT PROGRAM AND WE CONTINUE TO BE INCLUDED IN THE BRCs. WE ALSO ENSURE BETTER LINKAGE BETWEEN BRC WITH OTHER KNOWLEDGE BASES. AND WE ARE HOPING THAT THE CURRENTLY DEVELOP DATA ECOSYSTEM MAY FURTHER HELP SUPPORT THESE EFFORTS EARLIER SUMMARY SLIDE THIS CONCEPT IS TO SUPPORT THANK YOU VERY MUCH FOR YOUR ATTENTION, HAPPY TO TAKE ANY QUESTIONS. >>ANY QUESTIONS FROM ANY ADDITIONAL COMMENTS FROM THE COUNCIL MEMBERS THAT REVIEWED THIS CONCEPT? ANY SPECIFIC QUESTIONS? >>I WOULD LIKE TO MAKE ONE COMMENT. ONE OF THE THINGS THAT IS OBVIOUS FROM THE PRESENTATION THAT IS STRIKING, IS WHAT STARTED OUT AS A VARIETY OF EFFORTS AND BECAME PROGRESSIVELY MERGED INTO TWO CENTERS AND WHAT IS STRIKING IS THAT THIS HAPPENED AT A TIME OF MASSIVELY EXPANDING AMOUNTS OF DATA AND RAPIDLY CHANGING TECHNOLOGIES. AND INFORMATIC TECHNOLOGIES. AND I THINK MY PERCEPTION IS NOT ONLY AMOUNT OF DATA THAT IS INCREASING BUT THE NATURE OF THE DATA, IN OTHER WORDS RUNNING EVEN TO MORE METADATA EVEN EXPANDING FROM WHAT ORIGINALLY START AS GENOME SEQUENCE DATA NOW THROUGH METADATA AND EVERYTHING IN BETWEEN. TO ME IT IS NOT ONLY IMPRESSIVE ACCOMPLISHMENT BUT IT IS PRETTY OBVIOUS THAT THE COMMUNITY IS USING IT SO REALLY SUPPORTIVE OF THIS. >>ANY OTHER COMMENTS OR QUESTIONS? >>I WANT TO ECHO WHAT KEN SAID, I WAS IMPRESSED HOW THIS EVOLVED OVER TIME AND IT DOES SEEM TO BE A TREMENDOUS RESOURCE FOR PEOPLE. THE ONLY QUESTION I HAD IS WHETHER THE SCOPE OF EVERYTHING THAT IS DONE IS READILY KNOWN BY SOME OF THE MORE JUNIOR INVESTIGATORS DECEMBER SIMILARNATE THIS INFORMATION. -- DISSEMIN DISSEM. >>I CAN SPEAK FROM PERSONAL EXPERIENCE. I THINK IT'S BEEN SOMEWHAT CONSTRAINED BY THE LACK OF PEOPLE ATTENDING MEETINGS. I KNOW THAT ARE ALWAYS PRESENT AT SCIENTIFIC MEETINGS AND GIVE PRESENTATIONS. SO THERE IS A STRONG OUTREACH TO TRY TO INFORM PEOPLE ABOUT THE SERVICES FROM THESE PLATFORMS. >>BOTH BRC CENTERS HAVE OUTREACH ACTIVITIES. WE HAVE MULTIPLE CHANNELS, SCIENTIFIC MEETING IS ONE OF THEM, OTHERS HAVE MENTIONED, ALSO VERY ACTIVE IN OTHER TYPE OF SOCIAL MEDIA, CHANNEL AND ALSO REGULARLY CONDUCT WEBINARS AS WELL AS IN PERSON MEETINGS. SO THOSE ARE ONE OF THE MULTIPLE THAT HAVE THEM THROUGHOUT THE YEARS. THANK YOU. >>I THINK THAT WRAPS P OUR FIRST PRESENTATION OF THE VIRAL INFORMATICS CONCEPT. THANK YOU, MARIWIRIYA. OUR NEXT CONCEPT FOR YOUR CONSIDERATION IS ENTITLED ANAL MODELS FOR HEPATITIS B AND C. THIS WILL BE PRESENTED BY DR. KOSHY OF THE VIROLOGY BRANCH. ARE YOU HERE? >>I'M HERE. >>THERE YOU ARE. >>GOOD AFTERNOON, EVERYONE. TODAY I WANT TO PRESENT AN INITIATIVE ON ANIMAL MODELS FOR HEPATITIS B AND C. THIS INITIATIVES FOR CREATION OF CONVENIENT SMALLER MODEL SUPPORT INFECTION AND REPLICATION OF HEPATITIS B AND C VIRUSES, NOT NECESSARILY THE SAME MODEL. IN THE BEST CASE POSSIBLY MAY LEAD TO OUTCOMES OF VIRUS CLEARANCE INDUCER SUCLEARANSWER PERSISTENE ANTICIPATE USING UO 1 MECHANISM FOR THE AWARDS. SO THE ENORMOUS BURDEN OF CHRONIC VIRAL HEPATITIS AFFLICTS ALMOST 300 PEOPLE WORLDWIDE. IT RESULTS IN ALL THOSE -- ACTUALLY MORE THAN A MILLION DEATHS EVERY YEAR. WHICH OCCUR BECAUSE VERY SERIOUS DISEASES WHERE CHRONIC INFECTION PROGRESS TO CIRRHOSIS AND LIVER CANCER AND END STAGE LIVER DISEASE. SO FOR THE PREVENTION AND TREATMENT OF THESE TWO DISEASES, THOSE ARE REALLY VERY CLEAR AND THESE GOALS ARE SHARED BY THE WORLD HEALTH ORGANIZATION U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. AND THE NATIONAL INSTITUTES OF HEALTH. FOR HEPATITIS B WE HAVE HAD VERY EFFECTIVE VACCINE FOR ALMOST 40 YEARS. STILL IMPROVED VACCINES ARE NOW AVAILABLE -- APPROVED BY THE FDA. THE CURRENT CRISIS IN HEPATITIS B ACTUALLY IS BECAUSE OF DELAYS IN LOGISTICAL PROBLEMS IN UNIVERSAL ADOPTION OF VACCINES. SURPRISINGLY EVEN IN THIS COUNTRY, THERE IS NOT 100% COVERAGE OF VACCINATION OF INFANTS WHICH IS THE RECOMMENDED COURSE OF -- CAUSE OF VACCINATION. THERE ARE NO CURATIVE DRUGS. WE HAVE A FEW VERY USEFUL DRUGS I MIGHT SAY BECAUSE THEY INHIBIT VIRAL REPLICATION AND THEY SEEM TO PROGRESSION OF DISEASE. THE MOMENT YOU RELEASE YOU REMOVE DRUGS YOU GET THE VIRUS REPLICATION COMING BACK QUITE VIGOROUSLY. THESE DRUGS ARE USED TYPICALLY FOR MANY YEARS, SO IT IS NOT SATISFACTORY. FOR HEPATITIS C, THE OPPOSITE IS THE CASE WHERE WHAT IS KNOWN AS THE OPIOID CRISIS AND PEOPLE WHO INJECT DRUGS IN THE U.S. THERE IS NO VACCINE TO PREVENT INFECTION. SO THE NEED FOR EVALUATION IN ANIMAL IS VERY GREAT. WE NEED TO DISCOVER NEW DRUGS PARTICULARLY FOR HEPATITIS B VIRUS. AND TO TEST PROPHYLACTIC THERAPEUTIC VACCINES FOR HEPATITIS C. EVALUATION OF IMMUNOTHERAPIES THAT MIGHT HELP IN THE CASE OF CHRONIC HEPATITIS INFECTION. TO IDENTIFY NON-INVASIVE BIOMARKERS TO ASSESS RESPONSES, WHICH IS REALSO VERY IMPORTANT. THE NEED IS ALSO THERE FOR DEVELOPING ALONG WITH THESE MODELS SPECIFIC REAGENTS MOLECULAR AND BIOLOGICAL TOOLS WHICH ARE REQUIRED. NOW, THE MODEL FOR HEPATITIS B AND C WOULD BE A SMALL TRACTABLE -- TO BE FULLY IMMUNOCOMPETENT SO YOU CAN ASSESS THERAPY OF THE VACCINES AND CAN BE INFECTED WITH HBV AND/OR HCV AND SUPPORT REPLICATION OF VIRUSES. RIGHT NOW HUMANS AND CHIMPANZEES ARE THE ONLY HOSTS FOR HBV AND HCV, THE HOSTS CHIMPANZEES IN THE WILD AFFECTED BY READILY INFECTED VIRUSES, HAVING USE FOR VERY LONG TIME THE STUDY MOLECULAR BIOLOGY AND SUB BIOLOGY OF THE VIRUSES.ES. THE LAST SEVERAL YEARS WE HAVE A MORATORIUM ON CHIMPANZEE RESEARCH SO WE ARE FORCED TO LOOK ELSEWHERE FOR (INAUDIBLE). THERE ARE GENETICALLY SIMILAR VIRUS THAT EXIST IN SEVERAL OTHER SPECIES. AND SOME OF THESE ARE LISTED HERE GOT SOME NICE PICTURES I THOUGHT YOU MIGHT EBB JOY LOOKING AT. FOR HEPATITIS B VIRUS WHICH BELONGS TO THE ADENOVIRUS YOU MAY DISCOVER IN SEVERAL NON-HUMAN PRIMATES AS YOU SEE HERE, ALONG WITH OTHER -- AND EVEN SNAKE AND FISH. SEVERAL ARE USED, IN PARTICULAR THE WOODCHUCK TO ASSESS ANTIVIRAL DRUGS. A FEW OF THESE ANIMALS CAN BE INFECTED WITH HBV FOR EXAMPLE THE SQUIRREL MONKEY, YOU NEED TO IMMUNOSUPPRESS, THEREFORE LIMITS THEIR USEFULNESS. HCV IS A PROTOTYPE ACCORDING TO MEMBER OF GENUS CAPACITY VIRUS FOR THE FAMILY (INAUDIBLE) AGAIN LIKE IN HEPATITIS B VIRUS TREE SHREW HAS INFECTION BUT IMMUNE SUPPRESSION OF THESE ANIMALS. NON-PRIMATES VIRUSES HAVE BEEN IDENTIFIED IN HORSES AND CANINE VIRUS IN DOGS AND THERE ARE RELATED TO HCV AND ITS ORGANIZATION AND IN THE WAY THEY ARE -- THEIR GENOME STRUCTURE IS ORGANIZED. CHRONIC INFECTION IS RARE EXCEPT IN IMMUNODEFICIENT ANIMALS RECENT LIFER RAIL RATS IN NEW YORK CITY ARE SHOWN TO HAVE SEVERAL RAT CAPACITY VIRUS SPECIES AND ONES THAT ISOLATE USED TO OBTAIN FURTHER DETAILS IN -- WE NOW HAVE ANIMALS THAT CAN EITHER ACUTELY OR CHRONICALLY INFECTED WITH VIRUSES, AGAIN, THIS IMMUNOCOMPETENT RATS, THIS IS A BREAK THROUGH BECAUSE IT ALLOWS US TO COMPARE HOST RESPONSES IN THE DICHOTOMOUS OUTCOMES WITH VIRUS INFECTION. THE RISE OF VIRUSES ARE ALSO WITH THE (INDISCERNIBLE) HOWEVER PERSISTENT INFECTION IS STILL NOT POSSIBLE. SO THE SCENARIOS FOR DEVISING MODELS, SPECIFIC QUESTION THE INFECTION OFEN MALL WITH THE HUMAN VIRUS WOULD BE THE MOST CHALLENGING SPECIES AND TISSUE SPECIFIC REQUIREMENTS WERE ACCEPTED AND REPLICATION PATHWAYS. THE PERFECT MODEL ALSO RECAPITULATED CLINICAL MANIFESTATION FOR CHRONIC INFECTION IN HUMANS. THIS FEATURE CANNOT BE EASILY DETERMINED, VERY LONG PROGRESSION INTO THOSE DISEASE INFECTION AND DISEASE. SO ALTERNATIVES INCLUDE TRANSGENIC MICE THAT EXPRESS HBV FROM INTEGRATED HBV GENOMES AND TEST ANTIVIRAL APPROACHES, AND AS AN IMMUNE COMPETENT ANIMAL TRANSGENIC MICE ARE UTILIZED FOR SOME KIND OF IMMUNE -- I MUST MENTION THE ENDOGENOUS PRESENCE OF HBV INDUCES TOLERAN TOLERANCO SOME KIND OF IMMUNE RELATED RESEARCH ARE NOT IN THE MICE. THEN THERE'S THE RECENT IDENTIFICATION OF RECEPTORS FOR THE ENTRY OF THE HE TIE AT THIS B VIRUS AND ALSO -- HEPATITIS B AND C VIRUS AND MODELS ARE BEING CREATED WHERE THESE ARE BEING EXPRESSED IN CELL LINES AND IN SMALL ANIMALS TO MAKE HBV ENTRY BUT THERE ARE VARIOUS REPLICATION OF VIRUSES EVEN IF YOU CAN GET THEM SO WE ARE NOT THERE YET. BUT IN TERMS OF DRUG DEVELOPMENT THESE MODELS CAN BE USEFUL BECAUSE DIFFERENT MODELS WHICH PERMIT DIFFERENT ASPECTS OF ENTRY AND REPLICATION THAN WE USE SPECIFIC APPLICATIONS. IT MAY NOT BE NECESSARY TO TO HAVE ALL THESE POSSIBILITIES IN A SINGLE ONE. WE COULD USE MODELS THAT LIMITED POSSIBILITY. THEN OF COURSE THERE IS THE ZERO TRANSPLANTATION MODEL, THE SO CALLED HUMANIZED MICE MODELS, WHICH REALLY INVOLVE IMPLANTATION OF HUMAN HEPATOCYTES AND IN THESE ANIMALS THE MOUSES OWN HEPATOSITES ARE DESTROYED SO YOU HAVE LIVER LARGE SCALE HUMAN HEPATOSITES. THESE ARE THEN AMENABLE TO INFECTION BOTH HEPATITIS B VIRUS AND C VIRUS, IN THE CREATION OF THESE HUMANIZED MODELS, IMMUNE SYSTEM HAS BEEN DEGRADED. NECESSITY, AND SO NOW THERE ARE ALSO SOME MODELS WHERE FUNCTION OF HUMAN IMMUNE SYSTEM HAS BEEN INTRODUCED IN THESE ANIMALS. THEY ARE DUALLY ENGRAFTED WITH HUMAN HEPATOCYTES AND FUNCTIONAL HUMAN IMMUNE SYSTEM. LASTLY, THERE IS CASE TO BE MADE FOR VIRUS OR HOST ADAPTATION FIRST BY REPEATED ATTEMPTS TO INFECT THEM WITH DIFFERENT ISOLATES. THERE IS SOME SUCCESS WHERE YOU HAVE THAT C VIRUS APPLICATIONS TO HAVE A VIRUS ADAPTED SCENARIO. SORRY ABOUT THAT. SORRY ABOUT THAT. IS THIS WHERE YOU WANT TO BE, RAJEN? OR DO YOU WANT -- >>I HAD A COUPLE OF SLIDES, I DON'T KNOW WHAT HAPPENED. >>BACKWARDS, RIGHT? >>YEAH. >>BACKWARDS, PLEASE. REVERSE. RAJEN, ARE WE WHERE YOU WANT TO BE? >>I DON'T SEE SLIDES. >>OKAY. IT'S PURPOSE OF THE INITIATIVE IS WHAT IS TITLE IS. >>ALL RIGHT. >>I DON'T KNOW WHAT SLIDE NUMBER. I CAN'T TELL THAT FROM THE DISPLAY. >>YEAH. SORRY ABOUT THAT. OKAY SO LET ME ASK YOU SO (INAUDIBLE) SLIDES -- COUPLE OF SLIDES. THIS INITIATIVE WILL INVITE APPLICATIONS ON ANY OF THE FOLLOWING APPROACHES. TO REFINE SURROGATE SMALL ANIMAL MODELS. AND TO OPTIMIZE DUAL HEPATOCYTE AND HIS TRANSPLANTATION. HIS TRANSPLANTATION IS REALLY NOT VERY EFFICIENT BECAUSE LEADS TO REALLY WEAK IMMUNE RESPONSES. OPTIMIZATION OF THAT MODEL IS SOMETHING THAT WE WOULD INVITE. THEN TO ENGINEER IMMUNOCOMPETENT MODELS TO EXPRESS HUMAN RECEPTORS AND FACTORS FOR HBV AND FOR HCV INFECTION. IN THIS REGARD THERE IS A VERY PROMISING MODEL IN THE MONKEYS IN THE RHESUS MONKEYS WHERE ONE OF OUR INVESTIGATORS HAS MANAGED TO INTRODUCE THE HUMAN RECEPTOR FOR HE TIE AT THIS B VIRUS IN THE TRANSGENE BUT IT TAKES A LONG TIME TO GENERATE ANIMALS THAT WILL BE READY FOR EXPERIMENTS. THAT IS THE STATE HERE AND NOW. THEN TO IDENTIFY NEW SPECIES FOR HEPATITIS B VIRUS, HEPATITIS C VIRUS. I THINK IT IS PERHAPS MORE PROMISING FOR HEPATITIS B VIRUS BECAUSE THE VERY LARGE NUMBER OF SPECIES AND FAMILIES THAT HAVE BEEN SHOWN TO BE INFECTED WITH SIMILAR VIRUSES SO THE LIKELIHOOD KEEP LOOKING YOU WOULD FIND OTHER POSSIBLE HOSTS FOR HBV. THEN WE WANT TO DEVELOP APPROPRIATE MODELS SPECIFIC TO REAGENTS AND MIGHT LEAD TO VALIDATE THESE MODELS BY THEIR RESPONSE TO CURRENTLY AVAILABLE DIRECTLY ACTING ANTIVIRALS AND ABILITY TO TEST SUPPRESSION OF THE HBV CCC DNA WHICH IS A TEST FOR ELIMINATING HBV. SO FINALLY I JUST WANT TO FIND REVIEWERS DR. HARRY GREENBERG AND DR. (INAUDIBLE), THEY WERE BOTH SUPPORTIVE AND HAD COUPLE OF COMMENTS. IN PARTICULAR DR. GREENBERG SAID YES, -- >>CAN WE MOVE THE SLIDES FORE PLEASE, ADVANCE THE SLIDES. THERE YOU GO. I THINK THIS -- COUNCIL FEEDBACK. THAT IS WHERE YOU ARE, RIGHT? >>THAT IS RIGHT. YEAH. SO DR. HARRY -- BOTH DR. GREENBERG AND DR. ESTES WERE SUPPORTIVE OF THIS INITIATIVE. AND DR. GREENBERG SUGGESTEDDED THAT WE TAKE A DEFINITIVE LOOK FOR MURINE HEP ADENOVIRUSES IN NATURE AND HOPE TO INCORPORATE THIS IDEA IN THE INITIATIVE. DR. ESTES WANTS TO KNOW WHETHER THE FDA MODERNIZATION ACT 2.0, WHICH WAS ENACTED IN DECEMBER OF 2022, MAY HAVE ANY PROFESSIONS FOR THIS PLAN. THIS ACT IS A MANDATE TO REQUIRING ANIMAL STUDIES FOR LICENSURE OF BIOLOGICAL PRODUCT. THAT IS BIOSIMILAR OR INTERCHANGEABLE WITH ANOTHER BIOLOGICAL (INAUDIBLE). IT ISN'T COMPLETELY BANNED TESTING ON ANIMALS BUT IT WOULD EMPOWER DRUG DEVELOPERS TO USE ALTERNATIVES WHEN FEASIBLE. SO AFTER DR. ESTES RAISED THIS -- DISCUSS BY SENIOR COLLEAGUE AT THE FDA, AND I WAS TOLD THIS TARGETS THE EXTENSIVE USE OF ANIMAL TOXICOLOGY TESTING OF DRUGS, AND CAUSE FURTHER REDUCTION REPLACEMENT WITH OTHER MEANS OF TESTING. BY 2030. SO I DON'T THINK YOU WILL HAVE ANY ADVERSE EXPECTATION FROM OUR INITIATIVE AND INDEED, MY DISCUSSIONS LED TO THE EARLY DEVELOPMENT ESPECIALLY ON VACCINES CANNOT EFFECT TESTIFILY OCCUR WITHOUT SUCH MODELS. SO NEXT SLIDE PLEASE. -- EFFECTIVELY. SO AGAIN DETAIL OF THE INITIATIVE, WHICH I SHOW YOU AT THE BEGINNING, I SHALL BE MOST PLEASED TO RECEIVE YOUR COMMENTS AND SUGGESTIONS. THANK YOU. >>THANK YOU, RAJEN. QUESTIONS OR COMMENTS FROM ANYBODY, ANY MEMBER OF COUNCIL? >>GO AHEAD. SPEAK UP. >>I WILL JUST ADD THAT I THINK RAJEN SAID IT BUT THOSE WHO AREN'T VERY FAMILIAR WITH HEP ADENOVIRUSES THEY RECALL OVER PLACE IN NATURE. AND FREQUENTLY THERE IS LITTLE COLONIES OR ISOLATED POPULATIONS OF DIFFERENT SPECIES THAT HAVE THESE VIRUSES. THEY JUST SEEM TO ME THAT MICE ARE ALSO ALL OVER THE WORLD IN VARIOUS POPULATIONS AND MORE SYSTEMATIC LOOK JUST FOR A MURINE HEP ADENOVIRUS WOULD BE INCREDIBLY USEFUL ESPECIALLY IN LOOKING FOR WAYS, BECAUSE IN ALMOST ALL THOSE POPULATIONS THE VIRUS IS CHRONIC AND AT MOMENT WE ARE NOWHERE NEAR GETTING RID OF CHRONIC HEPATITIS B VIRUS IN PEOPLE WHO ARE CHRONICALLY INFECTED. IT IS A HARD PROBLEM. A SMALL ANIMAL MODEL WOULD BE FABULOUS. >>THAT IS A GREAT IDEA, HARRY. I DON'T KNOW IF THEY WILL FIND ONE BUT SEEMS LIKE THERE IS A -- SHOULD BE A REASONABLE CHANCE THIS IF YOU LOOK HARD ENOUGH YOU WILL FIND ONE. >>MICE ARE EASY TO CATCH COME COMPARED TO WEIRD ANIMALS. >>I SEE ANOTHER HAND, GUY PALMER, DID YOU HAVE A QUESTION? >>JUST A COMMENT. WHEN YOU ARE LOOKING IN A FORMER LIFE I WAS A COMPARATIVE PATHOLOGIST DID RESIDENCE IN PATHOLOGY, ALWAYS WHEN THESE THINGS ARE FORMULATED TO BE VERY CLEAR THERE IS NO ANIMAL MODEL WHO WILL EVER RECAPITULATE THE HUMAN DISEASE. IT CAN BE USED IN ININSTRUCTIVELY TO DISSECT CERTAIN PARTS OF AN INFECTIVE PROCESS OR DISEASE PROCESS. AND THAT ALWAYS GETS INTO THAT AREA, THE CRITICISM IS DIDN'T RECAPITULATE THE DISEASE, WHICH IT NEVER WILL BUT TO BE VERY SPECIFIC ABOUT WHAT SPECIFIC ASPECTS YOU ARE LOOKING FOR, AND THEN HAVE THAT ANIMAL MODEL BE APPROPRIATE TO ADDRESS THAT PART OF -- >>ANIMAL MODEL WOULD BE TO ADDRESS CROWNICITY, THAT IS CHRONIC INFECTION, THAT IS THE MODEL YOU NEED. >>I THINK IT IS TO BE SPECIFIC ABOUT WHAT YOU ARE TRYING TO RECAPITULATE. >>I THINK THERE'S BEEN PROGRESS IN GETTING HEPATITIS B H WILL GROW IN HUMAN ORGANOIDS AND YOU CAN PUT THOSE INTO AN IMMUNOCOMPROMISED ANIMAL OR HUMANIZED ANIMAL. >>I'M SUPPORTIVE OF THE INITIATIVE, JUST THAT ALWAYS BEING CAREFUL WITH ANIMAL MODELS TO WHAT EXACTLY YOU WANT THEM TO DO. >>IT IS ALMOST CERTAIN THAT I THINK THAT TO GET RID OF CHRONIC HEPATITIS B IN HUMANS IS GOING TO REQUIRE A GENETIC ALTERATION OF THOSE HUMANS AND I WOULD LIKE TO DO THOSE EXPERIMENTS IN A CHRONICALLY INFECTED ANIMAL FIRST. >>FAIR ENOUGH. >>OKAY. ADDITIONAL COMMENTS OR QUESTIONS? ON THIS INITIATIVE? HEARING NO QUESTIONS, I PROPOSE WE MOVE ON TO THE NEXT CONCEPT. FOR YOUR CONSIDERATION, IT IS ENTITLED COLLABORATIVE PARTNERSHIP TO ADVANCE GLOBAL BIOMEDICAL RESEARCH PROGRAMS. PRESENTED BY STEPHANIE COOMES. ARE YOU THERE? >>I'M HERE, GOOD AFTERNOON, EVERYBODY. I'M STEPHANIE COOMES, PRESENTING ON BEHALF OF A TEAM OF US, BOTH IN DMID AND WITHIN NIAID'S OFFICE OF GLOBAL RESEARCH ON AN FY 24 CONCEPT COLLABORATIVE RESEARCH TO ADVANCE GLOBAL HEALTH RESEARCH. SO THE OBJECTIVE OF THIS CONCEPT IS TO DEVELOP IMPLEMENT ESTABLISH AND MAINTAIN A SUCCESSFUL COLLABORATIVE PARTNERSHIP TO ADVANCE HEALTH RESEARCH INTERNATIONALLY. THIS IS TECHNICALLY A NEW PROGRAM. WE ARE PROPOSING A COOPERATIVE AGREEMENT UO 1 MECHANISM AND ANTICIPATE ONE AWARD. THE FIRST YEAR ESTIMATED TOTAL COST OF THE INITIATIVE IS $350,000. THIS WOULD BE A BASE AWARD AND WE CONSIDER ADDITIONAL FUNDS FOR ADDITIONAL ACTIVITIES THAT MIGHT BE PROPOSED BY THE RECIPIENT. WE ALSO ARE WORKING WITH OTHER NIH INSTITUTES AND CENTERS WHO MAY -- MIGHT SIGN ON TO THE PROGRAM WE ARE ALSO PROPOSING THIS AS A LIMITED COMPETITION SO WE ARE PROPOSING ELIGIBILITY CRITERIA THAT LIMIT APPLICANT TO ORGANIZATIONS THAT HAVE AGREEMENTS OR FORMAL COLLABORATIVE RELATIONS WITH AT LEAST 140 NATIONS AND STAFF POSTED IN THOSE COUNTRIES. SO THE GOALS OF THIS PROGRAM ARE QUITE BROAD, THE FIRST GOAL IS TO DISSEMINATE SCIENTIFIC KNOWLEDGE TO FACILITATE GLOBAL HEALTH RESEARCH FINDINGS. STRENGTHENING INTERNATIONAL HEALTH RESEARCH ACTIVITIES INCLUDING PANDEMIC PREPAREDNESS AND THE RESEARCH RESPONSE, ENHANCING RESEARCH RELATED RESOURCES, ASSESSING AND EVALUATING HEALTH RELATED PROGRAMS FOCUSED ON HEALTH RESEARCH. AND FINALLY COORDINATING EXPERT ASSISTANCE FOR HEALTH RESEARCH PRIORITIES. SO FOR THIS PROGRAM I THINK IT IS IMPORTANT TO UNDERSTAND THE BACKGROUND AND HISTORY TO THIS CONCEPT. NIAID HAS SUPPORTED TWO AWARDS, PREVIOUSLY THAT SUPPORT SIMILAR GOALS TO WHAT WE ARE PROPOSING FOR FY 24. THE FIRST AWARD WAS MADE IN FY 13. THIS WAS A SOLICITED PROGRAM, IT WAS A COOPERATIVE AGREEMENT UNDER RFA AND AWARD MADE TO THE WORLD HEALTH ORGANIZATION. THEN IN FY 18, WHO CAME IN UNDER AN INVESTIGATOR INITIATED MECHANISM WITH ANOTHER -- WITH AN APPLICATION FUNDED TO CONTINUE MANY OF THE PROGRAMS THAT WERE MADE ACTIVE IN THE FY 13 AWARD. WE ARE NOW PROPOSING THIS FY 24 CONCEPT WITH SIMILAR GOALS. SO I'M GOING TO GO THROUGH A FEW EXAMPLES OF ACTIVITIES THAT WERE SUPPORTED THROUGH THE PREVIOUS PROGRAMS BECAUSE I THINK THEY ARE GOOD EXAMPLES OF THE TYPES OF ACTIVITIES THAT WE ANTICIPATE SUPPORTING WITH THE FY 24 PROGRAM. THE FY 13 AWARD TO WHO, THERE WAS A NUMBER OF DIFFERENT ACTIVITIES THAT WERE SUPPORTED. THERE WAS A MEETING FOR UTILIZATION OF THE YELLOW FEVER VACCINE, SUPPORT FOR THE EBOLA VIRUS OUTBREAK IN WEST AFRICA. A NEEDS ASSESSMENT FOR CHICKEN GUNIA RESEARCH, HHS PROVIDED BY MAIN NAME FOR CREATION OF GLOBAL OBSERVATORY AND WHO REFORM. THE NATIONAL CANCER INSTITUTE PROVIDED FUNDS FOR PROJECT FOCUSED ON CANCER MANAGEMENT AND LOW RESOURCE SETTINGS. THERE WAS A CONSULTATION ON UNIVERSAL INFLUENZA VACCINE RESEARCH AND THE NATIONAL INSTITUTE FOR MENTAL HEALTH PROVIDED FUNDS FOR RESEARCH BASE REPORT ON SUICIDE IN FY 18 THE COOPERATIVE AGREEMENT HAD A NUMBER OF DIFFERENT ACTIVITIES THAT WERE ALSO HAVE BEEN FUNDED. THERE WAS A PROJECT ADVANCING VACCINE DEVELOPMENT FOR SEXUALLY TRANSMITTED INFECTIONS. THE PROJECT SUPPORTED THE GLOBAL VACCINE IMMUNIZATION RESEARCH FORUM, THE GVRF MEETING THAT HAPPENS BIANNUALLY, ALSO SUPPORTED THROUGH THE FY 13 AWARD. THE NATIONAL INSTITUTE ON CHILD HEALTH AND HUMAN DEVELOPMENT SUPPORTED THE REHABILITATION RESOURCE DEVELOPMENT AND IMPLEMENTATION PROGRAM. NATIONAL INSTITUTE ON MENTAL HEALTH SUPPORTED A PROGRAM CALLED MH GAP, A MENTAL HEALTH RESOURCE PROGRAM, PARTICULARLY LOW AND MIDDLE INCOME COUNTRIES. THE NATIONAL -- THE NIH OFFICE OF DIRECTOR, NATIONAL CANCER INSTITUTE, AND NIAID ARE SUPPORTING THE WHO SCIENCE COUNCIL THROUGH THIS PROGRAM. ANTICIPATE SIMILAR ACTIVITIES FUNDED THROUGH THE FY 24 PROGRAM, THAT WE ARE PROPOSING. I WANT TO THANK THE COUNCIL MEMBERS, DR. PALMER AND DR. KEN SUIT FOR TAKING THE TIME TO REVIEW OUR CONCEPT AND MEETING WITH ME TO DISCUSS THEIR FEEDBACK. BOTH COUNCIL MEMBERS WHO WERE SUPPORTIVE OF THIS PROGRAM, DR. PALMER NOTED THE UO 1 APPEARS THE BEST MECHANISM FOR THIS PROGRAM, IT PROVIDES FOR CLOSE COORDINATION BETWEEN NIH AND THE RECIPIENT. THIS PROGRAM WOULD ENGAGE BEYOND NIAID AND DMID BUT ALSO OTHER NIH INSTITUTES AND THAT IS WHAT WE ARE PLANNING. THE BASE AWARD FOR THE PROGRAM IS MODEST, BUT PROVIDES MECHANISM FOR RESPONSE TO NEW GLOBAL HEALTH CHALLENGES THROUGH SUPPLEMENTS. DR. STEWART NOTED THAT THIS IS -- THERE IS A NEED FOR THIS INTERNATIONALLY FOCUSED PROGRAM, PROGRAM IS FLEXIBLE AND PROVIDES FORMAT THAT I ALLOWS RESPONSES TO UNANTICIPATED OPPORTUNITIES AND NEEDS. PROVIDED SOME PORTAL CONSTRUCTIVE FEEDBACK THAT WE CONSIDER MOVING FORWARD, WHICH IS HAVING A FRAMEWORK OR CONCEPTUAL GUIDELINES, THAT WILL DETERMINE WHICH ACTIVITIES WILL BE SUPPORTED. WITH THAT I WILL THANK YOU FOR YOUR ATTENTION AND I CAN ADDRESS ANY QUESTIONS. >>THANK YOU, STEPHANIE. SO CLEARLY THIS IS DIFFERENT THAN SOME OF THE OTHER THINGS WE CONSIDER WHICH ARE MUCH MORE RESEARCH PROJECT FOCUSED. ANY COMMENTS OR QUESTIONS FOR RECEIVE REPRODUCIBILITY SRESEARCH. ANY QUESTIONS OR COMMENTS FOR STEPHANIE? NO? OKAY. >>THANK YOU. >>THANK YOU. HOPEFULLY AS WE MOVE FORWARD YOUR RECORDING YOUR VOTES AND ANY ADDITIONAL ADVICE THAT YOU WANT TO REGISTER INTO THE ELECTRONIC COUNCIL BOOK. OUR NEXT CONCEPT FOR YOUR CLEARANCE FOR YOUR CONSIDERATION FOR CLEARANCE IS ENTITLED INTERNATIONAL RESEARCH AND INFECTIOUS DISEASES THE IRID. DR. GLENN MCGUGEN PROGRAM OFFICER IN DMID WILL PRESENT THIS CLEARANCE CONCEPT. >>THANK YOU SO MUCH. SO GOOD AFTERNOON, I'M GLENN MCGUGA IN, PROGRAM OFFICER IN DMID. I'M EXCITED TO SEE THE TWO UNIQUE AND IMPORTANT PROGRAM HERE AT THE INSTITUTE INTERNATIONAL RESEARCH INFECTIOUS DISEASES. JUST LIKE THE PREVIOUS CONCEPT THAT YOU SAW, THIS CONCEPT IS A BIT DIFFERENT THAN THOSE YOU NORMALLY SEE IN COUPLE OF WAYS. THE FIRST IS THE REALLY BROAD BOAT SO WE PURPOSEFULLY DESIGNED THIS PROGRAM, THE SCIENTIFIC SCOPE TO BE SUFFICIENTLY BROAD TO COVER THE FULL RANGE OF INFECTIOUS DISEASE RESEARCH TOPICS COVERED BY THE DIVISION. IN FACT IN THE PAST WE HAVE PARTICIPATION FROM DIVISION OF AIDS, SO THIS SPANS TWO DIVISIONS WITHIN THE INSTITUTE. AND THE SECOND UNIQUE ASPECT IS IS THAT ELLAGIC IS RESTRICTED TO NON-US-BASED INSTITUTIONS AND SPECIFICALLY THOSE RESOURCE LIMITED COUNTRIES. OVER THE NEXT FEW MINIS WILL GIVE A HISTORY OF THE PROGRAM AND TALK A BIT ABOUT HOW WE SEE THIS PROGRAM MOVING FORWARD. SO AS I'M SURE WILL COME NO SURPRISE TO THIS AUDIENCE, I HAVE THE LONG ROBUST HISTORY OF SUPPORT FOR GLOBAL HEALTH RESEARCH WITH ACTIVITIES IN MORE THAN 120 COUNTRIES. AND THAT FUNDING HAS INCREASED THE PAST SEVERAL DECADES, THESE DATA ARE A BIT OLD, FISCAL YEAR 2018. NUMBER OF YEARS AGO THE INSTITUTE CONVENE AD TASK FORCE ON MICROBIOLOGY AND INFECTIOUS DISEASE. THEY MADE A NUMBER OF RECOMMENDATIONS ONE PERTINENT FOR TODAY, AND THEY SAID BECAUSE INFECTIOUS DISEASE DO NOT RESPECT NATIONAL BOUNDARY, THE INSTITUTE SHOULD CONTINUE LONG STANDING EFFORTS TO FOSTER SUPPORT AND EVEN EXPAND WHERE POSSIBLE BROAD-BASED INTERNATIONAL STUDIES OF INFECTIOUS DISEASE. THIS PUTS NICELY TO BOTH PREVIOUS PROGRAM AND THIS PARTICULAR PROGRAM THAT I'M PRESENTING. SO AS BACKGROUND, THIS PROGRAM STARTED BACK IN 2005 WITH A SMALL RO 3 FIRST AND THEN LATER TO AN RO1 GRANT MECHANISM, THESE ARE SMALL AWARDS, 125,000 PER YEAR IN DIRECT COSTS FOR PERIOD OF FIVE YEARS. AS I MENTIONED THESE ARE ALL DIRECT FOREIGN AWARDS AND THIS HAS BEEN A JOINT DMID DIVISION OF AIDS INITIATIVE. THE GOAL OF THIS IS AIMED ADVANCING THE DEVELOPMENT OF LOCAL SCIENTIFIC EXPERTISE. AND REALLY BUILDING THAT LOCAL RESEARCH INFRASTRUCTURE. ALSO THE ELIGIBILITY LIMITED TO RESOURCE LIMITED COUNTRIES. SINCE THE BEGINNING OF THE PROGRAM I'M SHOWING THE RO1 AWARDS ON THIS SLIDE BUT WE HAVE BEEN ABLE TO FUND 130 AWARDS, THE MAJORITY HERE IN DMID, WITH 112 AWARDS AND ALSO ADDITIONAL 18 AWARDS IN THE DIVISION OF AIDS. WE HAVE ONE FUNDING ROUND LEFT FOR FISCAL YEAR 23, THOSE ARE PRESENTED TODAY AT COUNCIL. SO IF FUNDED THE THIS NUMBER WOULD BE A BIT HIGHER THAN THIS. SO THOSE 130 AWARDS HAVE SPANNED RESEARCH TOPICS AS YOU CAN SEE HERE. THIS IS NOT AN EXHAUSTIVE LIST. . BUT HOPEFULLY DEMONSTRATES IT COVERS VARIOUS TYPES OF DISEASES INCLUDING BACTERIAL VIRAL PARASITIC AND VECTORS. AND OF COURSE THERE ARE THE AWARDS FOCUSED ON HIV AIDS NOT CAPTURE ON THIS SLIDE BUT THOSE ARE THOSE 18 ADDITIONAL AWARDS IN THE DIVISION OF AIDS. SO THOSE AWARDS ARE MADE IN 26 DIFFERENT COUNTRIES YOU CAN SEE HERE IN THE SPAN THE GLOBE CENTRAL SOUTH AMERICA, SEVERAL COUNTRIES IN AFRICA AND ALSO IN ASIA. AND YOU CAN SEE THE BREAK DOWN OF NUMBER OF AWARDS PER COUNTRY ON THE LEFT-HAND SIDE OF THE SCREEN. IT IS DIFFICULT TO CAPTURE THAT METRICS OF SUCCESS FOR A PROGRAM LIKE THIS IT IS IMPRESSIVE THAT OVER AROUND 900 PUBLICATIONS ATTRIBUTED TO THIS PROGRAM. I PICKED OUT A FEW EXAMPLES HERE BASED ON THE NUMBER OF PUBLICATIONS PER BASE PROJECT. I HOPE YOU CAN SEE IS NOT ONLY DOES IT SPAN THE GLOBE, BUT AGAIN THOSE DIFFERENT ORGANISMS AND DESUBMISSIONS INCLUDING VIRAL DISEASE, BACTERIAL PARAIS ITIC AND ALSO VECTORS. IN THIS CASE INSECT SIDE RESISTANCE. IT IS IMPORTANT TO NOTE THESE SOME OF THESE PUBLICATIONS HAVE BEEN HIGH IMNOCTURNALS INCLUDING PNAS AND SCIENCE, THOSE FOCUSED ON ZIKA AND SHAGA'S DISEASE. MAJOR MEDICINE, THE LANSETT, JOURNAL OF EXPERIMENTAL MEDICINE, AND STI IS ONE OF THE HIV-1s FUNDED BY DIVISION OF AIDS AS WELL. THERE ARE OF COURSE OTHER SUCCESS STORIES OTHER THAN PUBLICATIONS THAT ARE BIT MORE CHALLENGING TO QUANTIFY, BUT THOSE ARE THE COLLABORATIONS THAT HAVE BEEN FORGED BETWEEN THESE ENDEMIC SCIENCES AND US-BASED INVESTIGATORS AND TRAINING OF THOSE NEW SCIENTISTS IN ENDEMIC AREAS AND LEADING TO THE ENDEMIC RESEARCH CAPACITY INCREASING IN THOSE AREAS AS WELL. SO MOVING FORWARD THE CONCEPTS SCOPE WE ANTICIPATE BEING SIMILAR AND THAT IS PROVIDING SUPPORT FOR HIGH PRIORITY INFECTIOUS DISEASE STUDIES THAT ARE PROPOSED BY THESE INTERNATIONAL INVESTIGATORS IN RESOURCE LIMITED COUNTRIES. WE AGAIN ANTICIPATE HAVING A REALLY BROAD SCOPE, SO COVERING FULL RANGE AGAIN OF INFECTIOUS DISEASE TOPICS COVERED BY THE DIVISION, EXCEPT FOR CLINICAL TRIALS. SO THE SCOPE OF THESE PROJECTS AND AMOUNT OF MONEY IS TOO SMALL TO SUPPORT CLINICAL TRIALS BUT EVERYTHING ELSE IS IMPORTED BY THIS PROGRAM. WE ALSO WILL ENCOURAGE COLLABORATION SO WE FOUND IN THE PAST WE DON'T REQUIRE THESE US-BASED COLLABORATIONS, BUT MAJORITY OF THESE APPLICATIONS HAVE SOME COLLABORATION AND WE INTEND TO ENCOURAGE THAT AGAIN MOVING FORWARD. SO WE SEE THIS PROGRAM AS IMPORTANT FOR NUMBER OF REASONS, I WILL SHOW A FEW ON THE SLIDE, THE FIRST IS THE ABILITY TO ADVANCE THE LOCAL SCIENTIFIC EXPERTISE. AND BUILD A LOCAL RESEARCH INFRASTRUCTURE. THE SECOND IS FORMATION OF LONG STANDING RESEARCH COLLABORATIONINGS. BETWEEN U.S. AND -- COLLABORATIONS BETWEEN U.S. AND INTERNATIONAL SCIENCES. ONE OF THE IMPORTANT BY-PRODUCTS OF THESE COLLABORATION IS INCREASED ACCESS TO ORGANISMS AND (INAUDIBLE) THROUGH THIS CAPACITY BUILDING IN THESE ENDEMIC REGIONS. SO WE SEE A RELATIVELY SMALL INVESTMENT, HAS LED TO HUGE PAY OFF OVER THE LIFE OF THIS PROGRAM AND WE REALLY WANT TO SEE THIS PROGRAM CONTINUE TO FUTURE. I WOULD LIKE TO GIVE A SPECIAL THANKS TO THE ASSIGNED REVIEWERS FOR THIS CONCEPT, DR. TAYLOR AND DR. BACKENSTED, THEY WERE BOTH OVERALL SUPPORTIVE. THEY THOUGHT IT WAS AN IMPORTANT PROGRAM, THEY HAD A FEW SUGGESTIONS AND COMMENTS, I'M SHOWING JUST FOUR ON THE SLIDE HERE. IN THE DISCUSSION. YOU CAN DEFINITERY GO INTO MORE DETAIL BUT BRIEFLY THE FIRST POINT WAS YOU PROBABLY NOTICED ON THE SLIDE LISTED AS NEW. YET I GAVE YOU A LOT OF HISTORY. THE REASON FOR THAT IS BECAUSE WE ARE GOING TO MOVE FROM A PROGRAM ANNOUNCEMENT OR PAR. TO REQUEST FOR APPLICATION. SO MOVING FROM PAR TO RFA NECESSITATES THAT WE LIST THIS AS A NEW OPPOSED TO A RENEWAL APPLICATION. WE CAN TALK MORE ABOUT THE RATIONALE FOR THIS IN THE DISCUSSION BUT ONE OF THE MAJOR BENEFITS OF DOING THAT IS IT ALLOWS THESE APPLICATIONS TO BE CLUSTERED AND REVIEWED. ALL BE REVIEWED TOGETHER. IN A SPECIAL REVIEW PANEL. THE SECOND WAS MENTIONED BY BOTH REVIEWERS AND THAT WAS CAN WE INCREASE PARTICIPATION FROM UNDER-REPRESENTED COUNTRIES. I WILL SAY THIS IS SOMETHING THAT WE HAVE NOTICED IN SOMETHING THAT WE ARE FOCUSED ON, TRYING TO INCREASE PARTICIPATION FROM THE LOW AND LOWER MIDDLE INCOME COUNTRIES. WE HAVE DONE SEVERAL ANALYSES INTERNALLY, WE HAVE BEEN IN CONFERENCE WITH THE OFFICE OF GLOBAL RESEARCH HERE AT NIAID. TO TRY TO REALLY INCREASE ONE OF THE DEFICITS WE FOUND IS WE TEND TO GET MORE APPLICATIONS FROM THE UPPER MIDDLE INCOME COUNTRIES COMPARED TO THE LOW AND LOWER MIDDLE. PART OF THAT IS ADVERTISEMENT, PART OF THAT MAY WI BE THIS NEXT POINT BROUGT BY DR. BOCKENSTEDT IS TRAINING ON GRANT WRITING. WHILE THERE ARE TRAINING AVAILABLE THROUGH NIH AND NIAID, WE DO HOPE TO HAVE SOME INFORMATIONAL WEBINARS AS PART OF THIS PARTICULAR PROGRAM AS WELL. IN FACT, SOON AS FOIA IS ISSUE AND APPROVED WE WOULD LIKE AN INFORMATIONAL WEBINAR TO HIGHLIGHT THE UNIQUENESS OF THE PROGRAM AND MAKE THEM AWARE OF THESE TRAININGS THAT ARE AVAILABLE AS WELL. THE FINAL POINT WAS THE ABILITY TO TARGET SPECIFIC PATHOGENS THROUGH THIS PROGRAM. PRESENT THE FOCUS AS I MENTION IS BROAD AND GOING TO BE INVESTIGATOR KNISH YEAHED IN TERMS OF THE POPICS THAT THEY PRESENT. HOWEVER, INITIATED. SINCE THIS IS AN RFA WE HAVE POTENTIAL OF UPDATING THE CALL THROUGH NOTICE OF SPECIAL INTEREST, SO IF WE WANT TO TARGET A PARTICULAR OUTBREAK, POTENTIAL PATHOGEN SUCH AS EBOLA VIRUS OR SOMETHING LIKE THAT. SO WITH THAT, THANK YOU FOR YOUR TIME AND I WELCOME YOUR SUGGESTIONS, YOUR QUESTIONS AND ANY FEEDBACK YOU MAY OFFER. THANK YOU SO MUCH. >>THANK YOU, GLENN. ANY COMMENTS OR QUESTIONS FROM THE REVIEWERS OR THE -- MEMBERS OF COUNCIL? >>THE OREGON THING TALK ABOUT IS THE SLIDE THAT SHOWED THE NUMBER OF GRANTS THAT WERE AWARDED IN DIFFERENT COUNTRIES. WE TALKED ABOUT WHETHER WE HAD LOOKED AT THAT OVER TIME TO SEE THAT IF GOING BACK DOWN TO THE LOWER, IF THOSE EVEN THOUGH THE SMALLER NUMBER OF GRANTS BUT MORE RECENT AASSIGNELY ASSIGNEDR AWARDED. >>HUE FOR BRINGING THAT UP. I DID ANALYSIS ON THAT AND SAW IT WAS RELATIVELY STABLE OVER TIME I CALL IT OUT WITH YOU DR. TAYLOR ON THAT AS WELL. BUT IT IS SOMETHING THAT WE ARE INTERESTED IN, REALLY ENCOURAGING, TALKING TO OUR COLLEAGUES IN THE OFFICE OF GLOBAL RESEARCH, ONE OF THE THINGS THEY FOUND IS JUST BEING ABLE TO ADVERTISE BETTER TO THE LOW AND LOWER MIDDLE INCOME COUNTRIES MAY INCREASE PARTICIPATION FROM THOSE. THAT IS THE FIRST THING WE ARE DOING. SO WE HAVE A SURVEY PLAN RIGHT NOW WHERE IT IS GOING TO BE IN COOPERATION WITH OGR AND OTHER PARTNERS, TRY TO GET AT THAT QUESTION, FIND OUT HOW TO DO -- DID YOU HAIR ABOUT PROGRAM, HOW CAN WE ADVERTISE BETTER AND HOW TO ENCOURAGE PARTICIPATION FROM THESE UNDER-REPRESENTED AREAS. >>THANK YOU. >>HAVE THERE BEEN ISSUES WITH DATA SHARING COMING OUT OF THESE PROGRAMS? OBVIOUSLY A LOT OF COUNTRIES ARE VERY CONCERNED ABOUT WHAT HAPPENS TO THEIR DATA ESPECIALLY HUMAN DATA INVOLVED WITH THAT. AND THE U.S. NOT BEING A SIGNATORY TO THE FOIA PROTOCOL. CURIOUS IF THAT COMES UP? >>THANK YOU FOR THAT QUESTION. SO THE WAY THESE ARE ASSIGNED, I'M NOT THE PROGRAM OFFICER FOR THEM, I SHEPHERD THE PROGRAM, THEY ARE ASSIGNED TO INDIVIDUAL PROGRAM OFFICERS SO THEY MAY WANT TO SPEAK INDIVIDUALLY TO THOSE, IF ANY ARE ON THE CALL BUT I CAN TELL YOU IN GENERAL AS PART OF THE FUNDING ANNOUNCEMENT THEY ARE REQUIRED TO SHARE DATA, THE NIH REQUIRES THAT. SO THEY DO THAT BY A PUBLICATIONS IF THEY HAVE MADE ORGANISMS THEY HAVE TO MAKE THOSE AVAILABLE TO THE RESEARCH COMMUNITY AS WELL. SO WE HAVE NOT SEEN THAT AS BEING A PROBLEM IN THE PAST BUT VERY GOOD POINT, THAT IS THE GOAL OF THE PROGRAM AS WELL, TO INCREASE ACCESS TO THESE KINDS OF ORGANISMS AND PATHOGENS OF INTEREST. >>ANYTHING ELSE TO SAY ABOUT THE IRIDS? OKAY. THANK YOU VERY MUCH, GLENN. >>THIS IS NOT SOMETHING (INAUDIBLE) -- >>IT IS. I THINK IT SHOULD BE IN -- IS IT NOT, DO YOU NOT SEE IT -- LILLIAN OR BARBARA DO YOU KNOW? >>I GUESS I SEE IT. >>THE COLLABORATIVE PARTNERSHIP IS WHAT STEPHANIE PRESENTED AND THIS IS INTERNATIONAL RESEARCH AND INFECTIOUS DISEASES. >>SORRY, I'M CONFUSED. >>IT IS OKAY. >>WE HAVE ONE MORE CONCEPT WHICH IS A BUNDLE OF CONCEPTS. ENTITLED RESEARCH AND DEVELOPMENT OF VACCINES AND MONOCLONAL ANTIBODIES FOR PANDEMIC PREPAREDNESS NETWORK. CAITLIN FROM THE VIROLOGY BRANCH WILL PRESENT THIS WHICH WE HAVE CLEVERLY CALLED THE REVAMPP NETWORK. >>I'M GOING TO CONTINUE TO USE THE REVAMPP NETWORK RESEARCH AND DEVELOPMENT OF VACCINES AND MONOCHOLINAL ANTI-GUYS FOR PANDEMIC PREPAREDNESS IS A MOUTHFUL. SO I WILL TALK ABOUT PROGRAM TODAY. IT DOESN'T SEEM LIKE I HAVE CONTROL OF THE SLIDES YET. IF SO CAN WE MOVE TO THE NEXT SPOT THEN? AS EMILY MENTIONED THIS IS THREE CONCEPTS ROLLED INTO ONE SO THE OVERALL OBJECTIVE OF THIS NETWORK IS TO ESTABLISH A NETWORK OF COMPREHENSIVE COOPERATIVE BASIC AND TRANSLATIONAL RESEARCH CENTERS. WHAT THEY ARE GOING TO DO IS DEVELOP GENERALIZABLE VACCINE AN MONOCLONAL ANTIBODY APPROACHES FOR PROTOTYPE VIRUSES. FROM FAMILIES OF HIGH PANDEMIC POTENTIAL. THEY WILL NEED TO VALIDATE THE SAME APPROACH THAT WORKS FOR THE PROTOTYPE WORKS FOR OTHER VIRUS WITNESS THAT FAMILY. THROUGH THIS PROCESS THEY ARE GOING TO ADVANCE SCIENTIFIC KNOWLEDGE FOR THE PROTOTYPE VIRUS THAT IS -- GRAB MY POINTER. KNOWLEDGE FOR THE PROTOTYPE VIRUSES ABLE -- IN ORDER TO BE ABLE TO DEVELOP THESE VACCINES AND MONOCLONAL ANTIBODIES. SO THIS IS A NEW CONCEPT. SINCE IT IS MULTIPLE CONCEPTS ROLLED INTO ONE IT WILL BE TWO MECHANISM USED. BIPHASIC COOPERATIVE U 19 PROJECT GRANT MECHANISM AND A UG 3 UH 3 GRANT MECHANISM, SO THE NETWORK WILL CONTAIN 6 TO 7 RESEARCH CENTERS AND ONE DATA COORDINATING CENTER AND FIRST YEAR COST IS UP TO $100 MILLION PER YEAR. >>SO THE WAY TO ESTABLISH THIS NETWORK IS THROUGH THREE COMPANION RFAs. FIRST CENTERS FOR (INAUDIBLE) SECOND FOR BUNYAVIRALES,. THEY WILL HAVE SIMILAR STRUCTURE, SIMILAR IDEAS. BUT THEY DON'T -- MAINLY SEPARATED BASED ON WHAT VIRUS FAMILIES ARE INCLUDED. I WILL TALK MORE LATER WHY WE MADE THAT SEPARATION SO FOR THE FLAVIVIRIDAE CENTER THIS IS A BIPHASIC U 19 AWARD MECHANISM, ONE OR TWO CENTERS FROM THIS FOA. FROM THE CENTERS FOR BUYAVIRALS, BE USE THE BIPHASIC U 19 MECHANISM, AWARDING 5 TO 6 CENTERS FROM THIS FOA. AND NETWORK WILL INCLUDE A COORDINATING DATA SHARING CENTER FOR THE CDSC, WHICH WILL USE UG 3 UH 3 MECHANISM AND ONE AWARDS HERE. AND IMPORTANTLY CENTERS FROM EACH OF THESE FOAs WILL COME TOGETHER TO FORM THE REVAMPP NETWORK. SO FIRSTLY TALK ABOUT THE TWO SETS OF RESEARCH CENTERS TOGETHER H. AGAIN CONCEPT FOR THEM IS VERY SIMILAR. SO I WENT THROUGH MOST OF THIS ALREADY BUT FOR THE RESEARCH CENTERS THEMSELVES THE OBJECTIVE IS TO ESTABLISH RESEARCH CENTERS COMPRISED OF MULTI-DISCIPLINARY TEAMS OF INVESTIGATORS. THAT ARE FOCUSED ON IN DEPTH BASIC TRANSLATIONAL RESEARCH ON PROTOTYPE VIRUSES FOR FAMILIES WITH HIGH PANDEMIC POTENTIAL. SO NIAMS IS THINKING ABOUT PANDEMIC PREPAREDNESS FOR A LONG TIME NOW, ESPECIALLY WITH INCREASE FREQUENCY OF VIRAL OUTBREAKS THAT WE HAVE SEEN LIKE 2014 WITH EBOLA, FOLLOWED BY 2016 WITH ZIKA AND WITH CORONA VIRUS. ONE OF THE THINGS THAT BECAME CLEAR WITH THE COVID-19 PANDEMIC,S IS THE WAY WE WERE ABLE TO RESPOND SO QUICKLY IS WE HAVE THIS PHASED FOUNDATIONAL KNOWLEDGE FROM CORONA VIRUSES BASED ON YEARS OF RESEARCH ON MRS AND SARS 1 AND THAT LED TO FOUNDATIONAL KNOWLEDGE, THINGS LIKE WHAT ARE PROTECTIVE ANTIGENS AND PROTECTIVE EPITOPES. WE HAD A GENERALIZABLE VACCINE SOLUTION WHERE THIS VACCINE CONCEPT IS APPLIED TO MULTIPLE CORONA VIRUSES SUCCESSFULLY SO THAT BASE KNOWLEDGE IS WHAT ALLOWED US TO RESPOND QUICKLY AND FOR MANY OTHER VIRUS FAMILIES WE ARE NOT NEARLY AS PREPARED. SO NIAMS HAS DEVELOPED A PANDEMIC PREPAREDNESS PLAN WITH THREE PRY PLAYER GOALS, SYSTEMATICALLY CHARACTERIZED KNOWN PATHOGENS TO FILL GAPS IN RESEARCH INFRASTRUCTURE TECHNOLOGY AND CAPACITY. AND TIME LINES FOR APPROVAL OF MEDICAL COUNTER MEASURES. THESE ARE NOT INDEPENDENT GOALS, THERE'S OBVIOUSLY OVERLAP BETWEEN THEM. SO THE REVAMPP NETWORK PARTICULARLY WILL FOCUS ON TWO GOALS, WHICH IS SYSTEMATICALLY CHARACTERIZING KNOWN PATHOGENS IN HOPES THAT SHORTENING TIME LINES FOR APPROVAL IF A VIRUS FOR ONE OF THESE FAMILIES BREAKS OUT. SO THESE REVAMPP CENTERS WILL USE THE PROTOTYPE PATHOGEN APPROACH FOR PANDEMIC PREPAREDNESS. THIS IS THIS CONCEPT DOING RESEARCH ON KNOWN PROTOTYPE VIRUSES SO BASIC IMMUNOLOGY BASIC VIROLOGY, IN DEPTH CHARACTERIZATION OF THE IMMUNE RESPONSE USING NEW TECHNOLOGIES LIKE THE TRANSCRIPTOMICS, THAT BASIC RESEARCH LEADS TO FOUNDATIONAL KNOWLEDGE, SO THINGS LIKE CORRELATES OF PROTECTION, MECHANISM OF PROTECTION, UNDERSTANDING ANGIOGENIC DIVERSITY AS WELL AS IDENTIFYING PROTECTIVE ANTIGENS AND PROTECTIVE EPITOPES. ONCE YOU HAVE THE FOUNDATIONAL KNOWLEDGE THAT ALLOWS YOU TO THEN MAKE GENERALIZABLE VACCINE MONOCLONAL SOLUTIONS WITH THAT KNOWLEDGE. A KEY COMPONENT OF THIS APPROACH IS DELIVERABLE IS NOT -- IS THE GENERALIZABLE STRATEGY SO HAVING A STRATEGY THAT WORKS FOR MULTIPLE MEMBERS OF VIRUS FAMILY, NOT HAVING A DIFFERENT VACCINE FOR EVERY FAMILY MEMBER, DIFFERENT MONOCLONAL FOR EVERY FAMILY MEMBER AND NOT HAVING A UNIVERSAL VACCINE. IT IS FINDING WHAT APPROACH WORKS FOR MOST VIRUSES IN THAT FAMILY. SO THE WAY WE SELECTED THE VIRUS FAMILIES WE WORK ON FIRST IS PRIORITIZE BASED ON PANDEMIC POTENTIAL, SO THESE ARE ALL THE VIRUSES THAT ARE KNOWN TO INFECT HUMANS, VIRUS FAMILIES THAT HAVE VIRUSES THAT ARE KNOWN TO INFECT HUMANS. SORTED BASED ON PANDEMIC POTENTIAL HIGH VERSUS MODERATE AND CURRENT EXISTING RESOURCES AND COUNTER MEASURES SO INITIALLY WE ARE FOCUS HERE ON THIS PURPLE BOX, THESE ARE VIRUS FAMILIES WHERE -- THAT ARE HIGH PANDEMIC POTENTIAL BUT ONLY MODERATE EXISTING RESOURCES. SO THE REVAMPP CENTERS WORK ON NINE SELECTED VIRUS FAMILIES. Z FIVE FALL WITHIN THE ORDER, NEW VIRUSES PERIGUNYP AND ADDITIONAL VIRUS FAMILIES OF FLAVIVIRIDAE, PARA AND PICO AND TOGA. THIGH ARE ENCOURAGED TO WORK ON MORE THAN ONE VIRUS FAMILY TO HAVE MORE BREADTH THROUGH THE NETWORK. SO AL HOE THESE VIRUS FAMILY ALTHOUGH THESE VIRUS FAMILIES FALL IN THE SAME BOX THERE IS DECENT VARIETY BETWEEN VIRUS FAMILIES. SO FOR SOME LIKE FLAVI, THERE'S MORE FOUNDATIONAL KNOWLEDGE THAT SOMETHING LIKE MAYBE THE PERIGUNYA VIRUS FAMILY. WHEN WE LOOK AT THESE AND SAW THIS DIFFERENCE WE DECIDED IT WOULD BE IMPORTANT TO SEPARATE INTO TWO DIFFERENT FOAs SO WE HAVE FOA REVAMPP CENTERS FOR FLAVI AND TOPI WHICH HAVE ADVANCE CANDIDATES AND REVAMPED THAT HAVE THE SLIGHTLY LESS DEVELOPED FEELS THAT CREATES A MORE BALANCED NETWORK TO WORK ON DIFFERENT PATHOGENS AND NOT JUST FOCUS ON ADVANCE CANDIDATES THAT MIGHT REVIEW BETTER SINCE LARGER FIELD THERE IS NOR BASIC KNOWLEDGE THERE. SINCE THE PRIMARY GOAL OF THESE REVAMPP CENTERS IS TO DEVELOP VACCINESTHEY WILL BE REQUIRED TO WORK ON VACCINE DEVELOPMENT, A KEY COMPONENT IS VALIDATING THE APPROACH THAT WORKS FOR THE PROTOTYPE VIRUS WORKS FOR OTHER FAMILY MEMBERS. THEY WILL BE ENCOURAGED TO USE PLUG AND PLAY BECAUSE WE WANT THESE APPROACHES TO BE VERY DEPLOYABLE SHOULD A VIRUS OUTBREAK, BREAK OUT. AND THEN INDUSTRY COLLABORATIONS WILL BE REQUIRED FOR LATE STAGE TRANSLATIONAL ACTIVITIES. WE WANT THESE INDUSTRY PARTNERS TO BRING THIS REGULATORY KNOWLEDGE, THIS MANUFACTURING KNOWLEDGE TO REALLY MAKE THESE DISCOVERIES QUICKLY TRANSLATESSABLE TO THEICALLY I CAN IN. -- TRANSLATABLE TO THE CLINIC. THEY WILL BE ABLE TO WORK ON ADDITIONAL VACCINE DEVELOPMENT PROJECTS OR MONOCLONAL ANTIBODY DEVELOPMENT, WITH THE IDEA OF ONCE DEVELOPING AND FINDING CANDIDATE MONOCLONAL ANTIBODIES THEY WILL VALIDATE THAT ANTIBODY WITH SIMILAR PROPERTIES AND FUNCTION SO THE EPITOPES HOW IT NEUTRALIZES THAT IT IS PROTECTIVE FOR OTHER FAMILY MEMBERS AS WELL. THEN ALSO BE ABLE TO WORK ON FOUNDATIONAL RESEARCH, THESE ARE THINGS LIKE KNOWLEDGE, REAGENTS MODELS ASSAYS, ANYTHING YOU NEED TO DEVELOP AND TEST VACCINES. SO THE REVAMPP CENTERS UTILIZE MILESTONE BASED BIPHASIC U 19 GRANT MECHANISM SO PHASE 1 IS FIRST THREE YEARS, FOLLOWED BY PHASE 2, YEARS FOUR AND FIVE. SO WE EXPECT DEFUNDING CENTERS FOR FIVE YEARS, HOWEVER USING THIS BIPHASIC MECHANISM GIVES ADDITIONAL FLEXIBILITY. SO WE CAN CURTAIL UNDERPERFORMING PROJECT AND REPRIORITIZE PROJECTS IF NEEDED. ONE THING VERY IMPORTANT THROUGHOUT THIS PROCESS IS TO REALLY MAKE THIS REVAMPP NETWORK INTEGRATING WITH OTHER NIAID PROGRAMS SO SOME OF THESE PROGRAMS ARE HOUSED WITHIN DMID, SO WE ARE WORKING CLOSELY WITH THEM TO FIGURE HOW REVAMPP WILL FIT IN, HOW TO SHARE RESOURCES AND CORPMENT EACH OTHER. WE ARE LOOKING OUTSIDE DMID AND WORKING WITH SOME DATE PROGRAMS AND INTRAMURAL COLLABORATORS AS WELL. SO A NIAID WIDE EFFORT TO SPREAD THAT ON. WE ENVISION VACCINES OF MONOCLONAL ANTIBODY CANDIDATES THAT ARE DEVELOPED THROUGH THE REVAMPP PROGRAM TO BE ABLE TO BE TESTED AND SOME OF OUR PHASE 1 MECHANISMS, SUCH AS THE IDCRC, EARLY CLINICAL PHASE CONTRACTS. AND TRANSITION THESE PRODUCTS TO PARTNERS WHO ARE ABLE TO DO MORE ADVANCE DEVELOPMENT. SO ONE KEY FOR US IS COLLABORATIONS AT ALL LEVELS, MAJOR EMPHASIS OF THIS NETWORK. SO THE CENTERS WITH THEMSELVES ARE TEAMS OF MULTI-DISCIPLINARY SCIENTISTS, THE CENTERS WITHIN THE NETWORK COLLABORATE AND WILL HAVE DATA SHARING. AS I MENTION WE WANT THE NETWORK TO COLLABORATE WITH OTHER NIAID PROGRAMS AND ALSO SHARING DATA WORKING WITH EXTERNAL PARTNERS THAT ARE ALSO HAVE A VESTED INTEREST IN PANDEMIC PREPAREDNESS. BECAUSE OF NEED FOR OVERALL COLLABORATIVE NETWORK, WE NEED A COORDINATING DATA SHARING CENTER TO HELP US MANAGE THIS BIG TASK SO THE THIRD CONCEPT IS REVAMPP COORDINATING DATA SHARING CENTER. THIS COMPREHENSIVE CDSC WILL SUPPORT COORDINATE AND MANAGE ACTIVITIES ACROSS THE REVAMPP NETWORK. IT IS NEW, WILL USE A UG 3 UH 3 MECHANISM. AND WILL AWARD ANTICIPATED 1 AWARD. SO SOME OF THE THINGS CDSC IS TASKED WITH WILL BE FACILITATING COLLABORATION ACROSS THE NETWORK SO WE KNEE AREAS OF OVERLAP, BETWEEN DIFFERENT CENTERS SHARING IDEAS AND ANIMAL MODELS, REAGENTS TOOLS PLATFORMS AND IMMUNOGEN DESIGN. DATA SHAREING IS A BIG PART OF THIS. SO CDSC DEVELOPED AND ADAPT EXISTING DATA SHARING PLATFORMS AND TEMPLATES. THE WORK WITH THE CENTER PIs, TO DEVELOP NETWORK WIDE GOVERNANCE STRUCTURE, A REVAMPP LEADERSHIP NETWORK AS WELL AS WORKING GROUPS AROUND SHARED IDEAS LIKE ANIMAL MODELS AND ASSAYS AND DEVELOPING GUIDANCE SOME DATA SHARING POLICIES FOR THE NETWORK ITSELF AND ALSO COLLATE AND FACILITATE INFORMATION EXCHANGE WITH SOME OF OUR KEY PARTNERS IN THE PANDEMIC PREPARENESS SPACE. SO SIMILAR TO OUR REVAMPP CENTERS THE CDSC WILL UTILIZE MILESTONE BASE BIPHASIC UG 3 UH 3 GRANT MECHANISM SO THE FIRST THREE YEARS IS UG 3, SECOND TWO YEARS WILL BE UH 3 AND SO THIS TRANSITION FROM PHASE 2 TO 3 WILL BE BASED ON CONTINUATION OF NETWORNETWORK. ABILITY TO FACILE COLLABORATION. LOOKING AT THE COUNCIL FEEDBACK, THANKS TO DR. TAYLOR AN -- FOR HELPFUL DISCUSSIONS. HIGHLY SUPPORTIVE OF THE CONCEPT, THEY HIGHLIGHTED THE IMPORTANCE OF THESE SELECTED VIRUS FAMILIES. THEY LIKE THAT IT WASN'T JUST VACCINE DEVELOPMENT FOR SPECIFIC VIRUS BUT THAT STRATEGY FOR ALL THE VIRUSES WITHIN THAT FAMILY. I HAD IT HIGHLIGHT AS WELL DISCUSSION POINTS THAT CAME UP. THE RESEARCH CENTERS WERE COMPRISED OF TEAMS OF INVESTIGATORS THAT MAYBE STRUCTURAL VIROLOGIST, MENOLOGIES AND IN BETWEEN. BUT ASKING THEM TO WORK ON MULTIPLE VIRUS FAMILIES YOU MAY HAVE A FLAVI VIRUS EXPERT TOGA VIRUS OR BU,NYA VIRUS AND PERI VIRUS EXPERT COMING TOGETHER. THERE IS A BIG SPREAD AND FOUNDATIONAL KNOWLEDGE FOR DIFFERENT VIRUS FAMILIES AND SO WE ARE IMAGINING A SPECTRUM OF ACTIVITIES WITH MORE ADVANCE FIELDS HAVING MORE ADVANCE ACTIVITIES. SIMILARLY WITH INTEGRATION OF INDUSTRY PARTNERSHIPS AND THAT BEING NEEDED FOR MORE ADVANCE DEVELOPMENT. SO WE ENVISION THAT TO BEING DIFFERENT FOR DIFFERENT FAMILIES. THERE WAS -- WE ACKNOWLEDGE THE BUNYA VIRUS FIELD IS LIMIT SOD WE ARE HOPING THAT THIS REVAMP CENTER WILL HELP STIMULATE RESEARCH IN THAT AREA. THERE WERE QUESTIONS ABOUT HOW THE CENTERS WOULD BE REVIEWED SO EACH CENTER WILL HAVE OWN SAD REVIEW PROGRESS ANNUALLY. BUT THE REVIEW FROM PHASE 2 -- PHASE 1 TO PHASE 2 WILL BE PERFORMED BY PROGRAM STAFF AND ALSO QUESTIONS AROUND SUCCESS OF COORDINATED CENTERS FOR OTHER PROGRAMS. SO WE ARE DEFINITELY LEVERAGING THE SUCCESS OF CDSC TYPE GROUPS. AND LESSONS LEARNED AS WE DESIGN EXACTLY WHAT WE ARE LOOKING FOR IN CDSC. SO THAT IS THE CONCEPT OVERALL, AGAIN THIS IS THREE CONCEPTS ROLLED INTO ONE. TWO SETS OF RESEARCH CENTERS, SEPARATED BY VIRUS FAMILY, MORE ADVANCED AND LITTLE LESS ADVANCE AND COORDINATING DATA SHARING CENTER COMING TOGETHER. OVERARCHING GOAL IS DEVELOP GENERALIZABLE APPROACHES FROM VACCINE MONOCLONAL ANTIBODIES FOR PROTOTYPE VIRUS AND VALIDATE OTHER FAMILY MEMBERS AND ADVANCE SCIENTIFIC KNOWLEDGE IN THOSE FIELDSES. HAPPY TO -- FIELDS. HAPPY TO TAKE QUESTIONS OR LISTEN FOR COMMENTS. >>THANK YOU, CAITLIN. >>THIS IS KEN. I HAVE A COUPLE OF QUESTIONS, FIRST A COMMENT. THIS EXCITING CONCEPT I REALLY LIKE COLLABORATIVE ASPECT OF THIS. SO THE QUESTIONS I HAVE, ONE IS THERE WILL BE A LOT OF RESOURCES PRESUMABLY WILL BE GENERATED DURING THIS ACTIVITY. WONDERING IF THERE IS A PROVISION FOR CAPTURING THOSE RESOURCES BECAUSE THE UTILITY WILL GO BEYOND WHAT IS INDIVIDUAL PROJECTEDS AND THE PROGRAM ARE. THEN MAYBE A RELATED QUESTION I HAVE IS THE TECHNOLOGIES USED FOR THIS, ARE GOING TO BE USEFUL IN OTHER AREAS OF INFECTIOUS DISEASES. WONDERING IF THERE IS SOME WAY OF FOR EXAMPLE NETWORKING ACCESS TO THOSE TECHNOLOGIES BECAUSE THOSE TECHNOLOGIES ARE DEVELOPING RAPIDLY AND THE ABILITY TO DEVELOP MORE HIGH THROUGH PUT METHODS AND ALSO TO RETAIN SOME OF THE MATERIALS BEING GENERATED FOR MANY INVESTIGATORS TO USE. I THINK ARE REALLY ATTRACTIVE ELEMENTS OF A PROGRAM LIKE THIS. I DON'T KNOW IF THIS IS THESE TWO ITEMS HAVE BEEN CONSIDERED. >>WE THOUGHT A LOT ABOUT THAT. THIS IS SOMETHING WE ARE INTERESTED IN. WE EMPHASIS COLLABORATION AND REAGENT SHARING AS MUCH AS POSSIB POSSIR SOME OF THE TECHNOLOGY WHEN YOU START GETTING INTO IP ISSUES THERE IS ONLY SO MUCH WE CAN DO ABOUT THAT. BUT WE ARE HOPING TO FOSTER ETHOS OF SHARING AND ALL THAT AS WELL. USING DEI RESOURCES AND THING LIKE THAT FOR DATA SHARING ON TOP OF STANDARD MECHANISMS THAT WE H WE HAVE. >>WHEN YOU TALK DO YOU MEAN REAGENTS LIKE NEW VIRUSES? >>I THIS IT IS GOING TO BE A BUNCH OF ANTIGENS GENERATED THAT MAY BE USEFUL TO OTHERS OUTSIDE OF THOSE WHO ARE ACTUALLY FUNDED THROUGH THIS ASSUMING NO SAFETY ISSUE OBVIOUSLY. I THINK ALSO AS MENTIONED CRYOPRESERVE B CELLS, THINGS LIKE THIS. AND THEN DEPENDING ON METHODS USED TO GENERATE ANTIBODIES, THEY COULD BE RECOMBINANT MATERIALS USEFUL AS WELL. SO THOSE ARE THE SORTS OF THINGS ENTERING MY MIND. >>WE ARE LOOKING WHAT THE RESOURCE, THAT IS ONE WAY WE HAVE TO TAKE THE -- A LITTLE BIT INVESTIGATORS FOR SHARING, WILL BE ABLE TO SHARE THINGS FREELY WITHOUT HAVING TO PRODUCE ASSESSING WITH THEMSELVES, AND SHARING WITH EVERYONE. >>I SEE HARRY'S HAND UP, NEW OR OLD, HARRY? >>THAT IS A NEW HAND. ANY THOUGHT HOW THIS SEEMS TO BE GREAT PRESENTATION, WONDERFUL IDEA. HOW DOES IT RELATE TO THE BRC? SEEMS TO BE INCREDIBLY OVERLAPPING WITH BRC, OBVIOUSLY IT IS MUCH -- IN TOE TOE WOULD BE BIGGER OR AS FAR AS NUMBER OF INVESTIGATORS IN THE VRC. >>I THINK WE DEFINITELY SEE THAT IS A PLACE TO FIND AREAS OF OVERLAP. PREMISE GROUP TO TALK ABOUT HOW WE WORK A LITTLE BIT THERE. THERE IS ALSO VIRUS FAMILY NOT NECESSARILY IN BRC, THE TYPE OF THINGS WE ARE WORKING ON RIGHT NOW. WILL IS NOT -- THE HIV ARE NOT INCLUDED IN THIS SO THERE IS AREAS OF SYNERGY BUT NOT NECESSARILY AREAS OF DIRECT COMPOSITION. >>BRC IS LOOKING FOR A NEW DIRECTOR I THINK. SO IS THAT PERSON MIGHT HAVE A DIFFERENT IDEA OR ANY CASE, I THIS I THE INTERACTION, ONE SHOULD FIGURE HOW BEST TO MAXIMIZE THE INTERACTION. >>DEFINITELY. WE ARE IN PREPAREDNESS WORKING GROUPS TOGETHER AND TALKING A LOT ABOUT HOW TO WORK TOGETHER. I CAME FROM THE BRC TOO, I WAS THERE FIVE YEARS. VERY AWARE OF THE BRC. >>YOU ARE RIGHT, HARRY. THIS IS A PROJECT, WE WOULDN'T FUND A LOT OF EXTRAMURAL INVESTIGATORS BUT MANY HOPEFULLY LOVE TO WORK WITH BRC INVESTIGATORS AND VICE VERSA. THEY JUST CAN'T FUND THE,PANSIVE GROUP OF -- EXPANSIVE GROUP OF INVESTIGATORS TO BECOME INVOLVED IN THIS PROJECT. IS >>I THOUGHTS IT WAS EXCITING TO BE IN A POSITION TO RESPOND RAPIDLY LIKE FOR COVID H ACCIDENTAL MAYBE JUST HAD TO CONVERT AND GO. SO THIS WILL BUTT US IN A POSITION TO BE ABLE TO DO THAT. >>ANY OTHER COMMENTS OR QUESTIONS FROM COUNCIL MEMBERS? I THINK ANY LAST WORDS LILLIAN OR BAR BRUIN THEM VOTING ON THE CONCEPT? THERE ARE PEOPLE WHO WILL COME AFTER YOU BY EMAIL IF YOU FORGET TO REGISTER YOUR VOTE. FOR ANY OF THESE CONCEPTS THAT WERE PRESENTED TODAY.MENT >>THAT IS TRULY COME AFTER YOU IF YOU HAVE NOT VOTED SO IF YOU DON'T WANT TO HEAR FROM ME, VOTE NOW. >>OTHERWISE, WE GOT A LOT OF BUSINESS DONE. IT IS 3:01 SO WE ARE ENDING EARLY. THANK YOU FOR BEING SO HELPFUL, SO ENGAGED BUT ALSO SO EFFICIENT. OF SO I THINK THIS CONCLUDES OUR MEETING AND WE CAN ADJOURN. WE WILL RECONVENE IN JUNE. >>JUNE 5. >>WITH I THINK THE SAME MEMBERSHIP, RIGHT, BARBARA? >>CORRECT. >>OKAY. >>THANK YOU, EVERYONE. >>FAIR WELL UNTIL NEXT TIME.