WELCOME YOU TO THIS AFTERNOON'S SESSION OF THE DIVISION OF ALLERGY IMMUNOLOGY AND TRANSPLANTATION SUBCOMMITTEE. I'M DAN ROTROSEN, DIRECTOR OF THE DIVISION. WE HAVE A UNUSUAL PRESENTATION SET TODAY BECAUSE IN LIGHT OF GOING FULLY BY ZOOM WE WANTED TO HAVE TIME TO COVER A FEW MORE THAN THE USUAL NUMBER OF CONCEPT CLEARANCES AND WITH THE POSSIBILITY OF CONNECTION PROBLEMS WE DECIDED NOT TO HAVE A SCIENTIFIC UPDATES AND PRESENTATIONS BY DAIT GRANTEES. WE HAVE FIRST OF THE CONCEPT PROPOSALS IS FOR A TRANSNIAID DATA SCIENCE PROGRAM, TWO CONCEPT CLEARANCES THAT WILL BE PRESENTED BY ISHWAR CHANDRAMOULISWARAN, WHO IS PART OF THE OFFICE OF DATA SCIENCE AND EMERGING TECHNOLOGIES, NOT A DAIT OFFICE BUT A TRANS-NIAID OFFICE SITUATED IN THE OFFICE OF THE DIRECTOR. ISHWAR WILL BE PRESENTING THESE TWO CONCEPT PROPOSALS AND GO UNTIL ABOUT 1:30, 1:35, INCLUDING TIME FOR QUESTIONS. FOLLOWING THAT WE WILL HAVE A NUMBER OF FISCAL YEAR 2020 CONCEPT CLEARANCES BY MEMBERS OF OUR STAFF, THERE ARE FIVE OF THOSE ALL TOGETHER. WE WILL DO AS WE USUALLY DO. BRIEF PRESENTATIONS, AND TIME AFTER EACH FOR QUESTIONS IF IT LOOKS LIKE THERE ARE CONCERNS ABOUT ANY OF THESE THAT RISE BEYOND THE EN BLOCK APPROVAL. THAT WE OFTEN DO. I WILL ASK FOR YOUR APPROVAL INDIVIDUALLY OTHERWISE WE WILL ASK FOR BLOCK APPROVAL AT THE END OF THE SESSION THIS AFTERNOON. SO ISHWAR GOOD AFTERNOON, DISTINGUISHED COUNCIL MEMBERS. MY COLLEAGUES AND OTHER MEMBERS OF THE AUDIENCE. THANK YOU FOR THIS OPPORTUNITY TO DAIT FOR PRESENTING THIS STATE OF DATA SCIENCE AT NIAID AS WELL AS CONCEPTS FOR CLEARANCE. THERE IS A SCIENTIFIC NEED -- LET ME JUST MOVE THE MOVE THE CAMERA ON TOP OF THE SLIDES. THERE IS A SCIENTIFIC NEED TODAY. AT NIAID BECAUSE PROJECTS ARE SEPARATING VERY LARGE DIVERSE AND COMPLEX DATA SETS THAT NEED AND THERE SAW CRITICAL NEED TO WRANGLE AND TRANSFORM THIS DATA INTO KNOWLEDGE. HENCE, THERE IS A NEED TO MAKE THIS DATA MORE FINDABLE, B ACCESSIBLE AND REUSABLE THAT FORMS THE FOUNDING PRINCIPLES OF THE FAIR PRINCIPLES. IN ADDITION THERE IS ALSO NEED TO MAKE THE SOFTWARE THAT TRANSFORMS THE DATA TO BE MADE MORE INNOVATIVE AND SUSTAINABLE. ONLY THEN CAN WE REALIZE THIS VERSION OF MODERNIZED INTEGRATED FAIR BIOMEDICAL DATA ECOSYSTEM THAT COMPRISES MODULAR COMPONENTS OF DATA TOOLS THAT ARE STANDARD BASED AND DRIVEN BY THE COMMUNITY. THIS SLIDE SHOWS YOU HOW DATA SCIENCE IS REPRESENTED IN NIA 'S PORTFOLIO AND THE LITTLE SLIVER OF A SLICE THERE COMPRISES OF JUST A LITTLE OVER 1% OF PROJECTS, HUNDRED PERCENT POW FOCUSED ON DATA SCIENCE. EVEN IF YOU INCLUDE THE PROJECTS THAT HAVE WET LAB COMPONENTS WITH SIGNIFICANT PORTION OF DATA SCIENCE, THERE'S STILL COMPRISE ONLY ABOUT UNDER 3% OF THE ENTIRE PORTFOLIO. HENCE THERE'S DEFINITELY A SIGNIFICANT NEED TO ADOPT DATA DRIVEN APPROACHES WITHIN OUR PROJECTS. TO ADDRESS THIS NEED, NIAID ESTABLISHED THE OFFICE OF DATA SCIENCE AND EMERGING TECHNOLOGIES WITH INTENT TO ADDRESS THIS NEED. THE OFFICE IS WORKING TO DEMONSTRATE NOT ONLY DATA SCIENCE THAT'S AS A DISCIPLINE BUT INITIAL LAUNCH OF AN UPDATE OF OUR WEBSITE TO ADDRESS DATA SCIENCE BUT ALSO IS LOOKING TO BUILD PARTNERSHIPS ACROSS THE INSTITUTE AMONG DIVISIONS AS WELL AS ACROSS NIH TO HARNESS THE POWER OF DATA IN IMMUNE MEDIATED INFECTIOUS DISEASE RESEARCH BY FIRST DEVELOPING A DATA SCIENCE STRATEGY AND RESEARCH PROGRAM, SECOND, PROVIDING DATA MANAGEMENT AND SHARING GUIDANCE AND IMPLEMENTATION THAT IS AN UPDATE TO THE NIH POLICY FROM 2003 THAT IS EXPECTED TO BE ROLLED OUT NEXT YEAR IN FISCAL YEAR 21. LASTLY, SUPPORTING WORK FORCE DEVELOPMENT TO RECRUIT DATA SCIENTISTS BOTH WITHIN THE INSTITUTE AS WELL AS AMONG GRANTEES WITH THE HOPE THIS WOULD ALIGN WITH THE NIH STRATEGIC PLAN FOR DATA SCIENCE. THE PRIORITIES OF THE OFFICE ARE TO ENABLE GREATER DISCOVERABILITY AND REUSE OF NIAID FUNDED DATA SETS, FACILITATE INTEROPERABILITY OF THE VARIOUS RESOURCES REPOSITORY AND KNOWLEDGE BASES THAT NIAID SUPPORTS. SUPPORTING OPPORTUNITIES FOR SUSTAINED DEVELOPMENT OF SOFTWARE TOOLS, AND PROVIDING OPPORTUNITIES FOR DATA SCIENTISTS. WE HAVE SEVERAL EFFORTS UNDERWAY TO ACHIEVE AND ACCOMPLISH THESE PRIORITIES AND SOME OF THE INITIATIVES THAT I WILL TOUCH ON THAT WE ALREADY INITIATED AND UNDERWAY INCLUDE IN FY 20 NIH JOINED OTHER INSTITUTES TO SIGN ON TO A BIOMEDICAL DATA REPOSITORY AND BIOMEDICAL FUNDING BASE OPPORTUNITY FUND ANNOUNCEMENT. ALONGSIDE THIS NIAID HAS ISSUED ITS PRIORITIES OF NOTICE OF SPECIAL INTEREST THAT FOCUSES ON PRIORITIES FOR THESE BIOMEDICAL REPOSITORY AND KNOWLEDGE BASE. THE INTENT OF THESE IS TO PROVIDE CONSISTENT RESOURCES SUCH THEY ARE EVALUATED BASED ON MEASURABLE SCIENTIFIC IMPACT, QUALITY, EFFICIENCY OF OPERATIONS, COMMUNITY ENGAGEMENT, AS WELL AS GOVERNANCE. NIAID IS ALSO MAKING SUPPLEMENTAL AWARDS TO MAKE DIGITAL OBJECTS FINDABLE INTEROPERABLE AND REUSABLE AND RECENTLY RECEIVED APPLICATIONS TO NOTICE OF SPECIAL INTEREST TO SUPPORT ENHANCEMENT OF SOFTWARE TOOLS FOR OPEN SCIENCE. NIAID IS ALSO SIGNED ON TO RFA FROM GENERAL MEDICINE THAT FOCUSES ON DEVELOPING TRAINING MODULES AS PART OF AN EDUCATION PROGRAM TO ENHANCE RIGOR REPRODUCIBILITY OF RESPONSIBLE CONDUCT OF BIOMEDICAL DATA SCIENCE. IN FY 22 THE FOCUS IS THREE PRONGED ON DATA REUSE. TRAINING, AS WELL AS TECHNOLOGY DEVELOPMENT WITH INCLUSION OF INDUSTRY PARTNERSHIP THROUGH SMALL BUSINESS INNOVATION RESEARCH AWARDS. TODAY I WILL FOCUS ON THIS COMPANION ASSOCIATED WITH TECHNOLOGY DEVELOPMENT AND ALSO SHARE THE CONCEPT TOPIC FOR THE SBIR. INITIATIVE. THIS PROGRAM IS CALLED A TRANSNIAID DATA SCIENCE PROGRAM OR AIDS WITH A STANDING FOR TOOL ACRONYM OF THE INSTITUTE PER SE. AND COMPRISES OF -- IS A TRANSNIAID PROGRAM THAT SUPPORTS INVESTIGATOR INITIATED DATA SCIENCE TECHNOLOGY DEVELOPMENT THAT IS DRIVEN BY CRITICAL NEEDS AND IMMUNE MEDIATED INFECTIOUS DISEASE RESEARCH. THE OBJECTIVES ARE FIVE FOLD. NAMELY TO ENCOURAGE GREAT HE WERE EMPHASIS ADVANCING THE SIGNS OF IMMUNE MEDIATED DATA SCIENCE RESEARCH, SERVING CURRENT EMERGING NEEDS ACROSS IMMUNE MEDIATED RESEARCH CONTINUUM, SUPPORTING INTEGRATED -- INTEGRATION OF DATA DRIVEN HYPOTHESIS GENERATION MOST IMPORTANTLY IN OUR PROJECTS, PROMOTE ORGANIZE CROSS PROGRAM COLLABORATION TO BREAK SILOS AND PROVIDING FLEXIBLE SUSTAINABLE SUPPORT THAT APE LINES THROUGH THE STAGE OF INFORMATICS AND DATA SCIENCE DEVELOPMENT WHICH IS SOMEWHAT LACKING TODAY. THE THREE COMPANION FOR, SUPPORT WHERE YOUR STAGE AS A I SAID THE FIRST IS ON DATA SCIENCE METHODS AND ALGORITHM DEVELOPMENT, THE SECOND AND EARLY STAGE DEVELOPMENT OF DATA SCIENCE TECHNOLOGIES AND A THIRD ON ENHANCEMENT AND SUSTAIN DATA SCIENCE TOOLS. WHY ARE WE DOING THIS NOW? THERE IS NO DEDICATED FUNDING OPPORTUNITY FOCUSED ON INFORMATICS AND DATA SCIENCE TECHNOLOGY TO BROADLY SERVE THE INSTITUTES RESEARCH CONTINUUM AND ENHANCE THE NEED. THE INTENT AS YOU SAW IN THE PORTFOLIO ANALYSIS, THE PRELIMINARY PORTFOLIO ANALYSIS THAT I SHOWED A FEW SLIDES AGO, THAT THERE'S A GAP AND NEED TO BE ABLE TO BETTER HARNESS THE POWER OF DATA AND ENCOURAGE DATA SCIENTIST AS PRINCIPLE INVESTIGATORS TO ADDRESS INFORMATICS CHALLENGES PERTAINING TO NIAID MISSION. THIS PROGRAM IS MODELED AFTER THE NATIONAL CANCER INSTITUTE INFORMATION TECHNOLOGY FOR CANCER RESEARCH PROGRAM. SO I'LL QUICKLY STEP INTO THE THREE COMPANION AND WHAT THEIR FOCUS AREAS ARE. FIRST IS AS I SAID EXPLORATORY DEVELOPING METHODS AND ALGORITHMS THAT FOCUSES ON DEVELOPMENT OF NOVEL COMPUTATIONAL MATHEMATICAL STATISTICAL ALGORITHMS AND METHODS INCLUDING ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING APPROACHES. THE APPLICATION APPLICANT PROVIDE CLEAR RATIONAL DESCRIBING HOW THE PROPOSED METHOD OR ALGORITHM IS NOVEL AND HOW IT WILL BENEFIT THE IMMUNE MEDIATED INFECTIOUS DISEASE RESEARCH COMMUNITY. THE MECHANISM IS R21 WITH DURATION AWARD TWO YEARS WHERE FIRST YEAR FUNDING LEVEL OF UP TO A MILLION DOLLARS. THE SECOND IS IS FOCUSED SECOND CONCEPT FOCUSES ON EARLY STAGE DEVELOPMENT OF DATA SCIENCE TECHNOLOGIES BY EARLY STAGE WE MEAN REFER TO PROTOTYPING AND HARDENING INCLUDING ADAPTATION AND BY ADAPTATION IMMUNE MODIFYING AND EXISTING APPLICATION TO SUPPORT A NEW USE CASE OR ANSWERS NEW QUESTION. HERE AGAIN APPLICANT MUST PROVIDE CLEAR RATIONAL EXPLAINING WHY PROPOSED TECHNOLOGIES NEEDED AND HOW IT WILL BENEFIT THE ADVANCE THE FIELD. THIS IS THE COOPERATIVE AGREEMENT MECHANISM OF UO 1 DURATION OF ABOUT UP TO THREE YEARS IN THE FIRST YEAR FUNDING SET ASIDE FOR A MILLION DOLLARS. THE THIRD AND FINAL PART OF THE COMPANION 4 IS FOCUS ON ENHANCEMENT ENHANCING DEVELOPMENTMENT OR SUSTAINING OPERATIONS OF EXISTING WIDELY ADOPTED APPLICATION OR TOOL. HERE THE APPLICANT MUST PROVIDE A JUSTIFICATION WHY THE RESEARCH SOFTWARE SHOULD BE ADVANCED OR MAINTAINED. AND HOW IT BENEFITTED AND WILL CONTINUE TO BENEFIT THE COMMUNITY THAT ALIGNS WITH OUR MISSION. IT'SRITICAL THE ENGAGEMENT WITH TARGETED RESEARCH COMMUNITY AND THIS IS A U 24 AWARD WITH THE SET ASIDE FUNDING FOR A MILLION DOLLARS. THAT COMPLETES THE THREE COMPANION IN TECHNOLOGY DEVELOPMENT AND THIS IS IN SHARING THE TOPIC ON SBIR TOPIC THAT GOES INTO THE FY 21 OMNIBUS THAT FOCUSES ON AGAIN ON TECHNOLOGY DEVELOPMENT TO SUPPORT DEVELOPMENT ENHANCEMENT OR ADAPTATION OR INNOVATION OF ROBUST INFORMATICS TOOLS WITH THE AIM OF SUSTAINING SOFTWARE DEVEPMENT AS PART OF OUR RESEARCH EFFORTS AS WELL AS BRINGING INDUSTRY PARTNERSHIP TO ENABLE COMMERCIALIZATION. SO THAT COMPLETES THE QUICK OVERVIEW OF THE CONCEPTS. HEARSAY THE TEAM FROM ACROSS DIVISIONS THAT PARTICIPATED IN PUTTING THIS TOGETHER. I ALSO WOULD LIKE TO TAKE A MOMENT TO THANK THE LEADERSHIP OF THE THREE DIVISIONS AND DIRECTORS AND DEPUTY DIRECTORS AS WELL AS DR. JILL HARPER FOR NOT ONLY PROVIDING INPUT AND BUT SO ENCOURAGING DATA SCIENCE AS FIELD ITSELF WITHIN NIAID. WITH THAT I'M HAPPY TO ANSWER ANY QUESTIONS. >> FIND DATA SCIENCE? >> YOUR QUESTION BROKE UP. WOULD YOU MIND REPEATING YOUR QUESTION? >> (INAUDIBLE) WHAT IS DATA SCIENCE? AN EXAMPLE OF DATA SCIENCE. >> SURE. SO DATA SCIENCE IS BROADLY DEFINED AND THE WAY WE ARE RYING TO CAPTURE THAT IS ANY KIND OF COMPUTATIONAL RESEARCH AND WE BEND INTO FOUR BROAD CATEGORIES HERE, ONE WE ARE MOSTLY FAMILIAR WITH IN TERMS OF DEVELOPING DATA REPOSITORY AND KNOWLEDGE BASES THAT BASICALLY MANIPULATES AND COLLECTS GATHERS AND MODIFIES AND PROVIDES SECONDARY ANALYSIS AND DATA SETS. ALSO INCLUDES ALL THE MODELING RESEARCH AND INFORMATICS RESEARCH BROADLY THAT USES SECONDARY ANALYSIS OF DATA TO INFORM HYPOTHESIS GENERATING -- DATA DRIVEN HYPOTHESIS GENERATION. IT ALSO COMPRISES OF PROJECTS THAT SERVE AS DATA COORDINATING CENTERS WHERE THERE IS A LOT OF GATHERING OF DATA TO PROVIDE THE SUPPORT FOR NETWORKS AND CONSORTIUM AND LASTLY THERE'S TRAINING ASSOCIATED WITH THIS WE HAVE VARIOUS PROJECTS SUPPORTING ADOPTING AND TRAINING PEOPLE TO LEVERAGE COMPUTATIONAL TOOLS HERE SO THAT'S THE BROAD DEFINITION HERE BASED ON WHICH WE ARE WORKING ACROSS OUR PORTFOLIO. >> QUICK QUESTION ABOUT REVIEW PROCESS. BECAUSE IT IS COMBINING EXPERTISE AND DATA SCIENCE AND YOU ENVISION SPECIAL EMPHASIS TYPE PANELS YOU BRING TOGETHER TO REVIEW THESE? >> ABSOLUTELY. THE SPECIAL -- THIS IS A SPECIAL EMPHASIS PANEL THAT WILL FOCUS ON REVIEWING ALL THE THREE TOGETHER BECAUSE I THINK THAT KIND OF EMPHASIZES -- HAS AN UNDERSTANDING OF THE STAGE IN WHICH THE PROMPT APOLOGETICS ARE WHETHER EARLY EXPLORATORY STAGE OR THERE'S A SIGNIFICANT USAGE OF IT AND IT IS A RESOURCE THANES TO BE SUSTAINED AND IT WOULD HAVE EXPERTISE IN THE COMBINATION OF INFORMATICS AND APPLICATION OF THE USE CASES, ABSOLUTELY VERY MUCH, THAT'S A CRITICAL COMPONENT AND A NEED TO DEMONSTRATE HOW IT WILL BENEFIT AND WHAT USE CASES IT WILL SERVE. >> THIS IS -- I HAVE A QUESTION. THANK YOU FOR THE PRESENTATION. YOU MENTIONED ABOUT THE R21 UO 1 U 24 TYPES ANNOUNCEMENTS BUT HOW ABOUT RO1 TYPE AND BECAUSE STANDARD STUDY SECTIONS WOULDN'T BE IDEAL FOR REVIEW OF THOSE TYPES OF APPLICAONS. >> ABSOLUTELY. THIS IS NOT REPLACING THE RO1 APPLICATION. THE UNSOLICITED DEFINITE COME IN, WE -- DEFINITELY COME IN, WE ENCOURAGE THOSE BUT THIS IS IN ADDITION TO PROVIDE COMMITMENT AND DEDICATED SUPPORT FOR VARIOUS KINDS OF DATA SCIENCE DRIVEN APPROACHES AND PARTICULARLY THIS IS FOCUSING ON SOFTWARE AND TOOL DEVELOPMENT BECAUSE A LOT OF THOSE ARE IN OUR CURRENT WET LAB PROJECTS AND AFTER THAT USE CASE THE QUESTION IS ANSWERED, THEIR SUSTAINABILITY BECOMES CHALLENGING. SO TO ENCOURAGE THOSE DATA SCIENCES THESE ARE DEDICATED APPLICATIONS AND THIS ALSO THE HOPE IS REPURPOSE BEYOND THE INITIAL APPLICATION THEY COME IN THAT SERVE A BROADER CASE. SO YES. THIS IS IN ADDITION TO WHAT IS ALREADY SUPPORTED. >> THANK YOU. >> I DON'T HEAR ANY MORE QUESIONS. THANK YOU VERY MUCH, ISHWAR. NOW WE CAN MOVE ON TO THE FIVE FY 22 DATE RESEARCH -- DAIT RESEARCH CONCEPT CLEARANCES. THE FIRST PRESENTED BY ADELINA BARTELS, THAT IS FROM THE REGULATORY MANAGEMENT CENTER. ADELINA, DO YOU HAVE SLIDES UP READY TO GO, ARE WE PROJECTING THEM FOR YOU? >> MY SLIDES ARE READY TO GO. >> CAN EVERYONE SEE MY SLIDES AS MUCH >> YES. >> GOOD AFTERNOON, MY NAME IS ADELINA, I WILL PRESENT THE REPERTOIRE MANAGEMENT CENTER CONTRACT TODAY. SO THE REGULATORY MANAGEMENT CENTER CONTRACT PROVIDES REGULATORY SUPPORT SERVICES FOR ALL ONGOING AND NEW FUNDED CLINICAL TRIALS AND NON-CLINICAL STUDIES. SO TWO MAIN ACTIVITIES THE RMC, ONE OF THE ACTIVITIES IS THE REGULATORY HEALTH AUTHORITY ACTIVITIES BEYOND -- PREPARATION SUBMISSION AND DISTRIBUTION OF REGULATORY FILINGS AND -- REPORT. THE OTHER -- AND ALSO MAINTAIN MANAGES REGULATORY SUBMISSIONS TO EACH PROTOCOL. THE SECOND IS QUALITY ASSURANCE, COMPLIANCE ACTIVITIES RELATED TO CLINICAL TRIALS SPONSOR OBLIGATIONS WHICH INCLUDES PROCESSING MAINTAINING AND MANAGING THE TRIAL MASTER FILES FOR EACH CLINICAL TRIAL. THE RNC ALSO SERVES AS A LEGAL REPRESENTATIVE IN CLINICAL TRIALS CONDUCTED OUTSIDE THE UNITED STATES. THE MAJOR ACCOMPLISHMENTS OF THE RNC THUS FAR IS IMPROVED EFFICIENCY BY THROUGH HARMONIZATION OF REGULATORY PROCESSES ACROSS STATE PROGRAMS, ESTABLISHMENT OF ELECTRONIC SYSTEMS AND USING THE FDA MANDATED REQUIREMENT OF ELECTRONIC IND SUBMISSION. ADDITIONAL ACCOMPLISHMENTS HAVE BEEN SUCCESSFUL OF NAVIGATION OF LEGAL REGULATORY REQUIREMENTS MAINTAINING HEALTH AUTHORITY INFECTION RADIUS AND ACCURATE COLLECTION OF COST DATA ASSOCIATED WITH CLINICAL TRIALS. SOME OF THESE MAJOR CHANGES THAT JUSTIFY INCREASE IN BUDGET ARE TWO OF THEM, ONE IS THE EXPANDED RESOURCES FOR HIRING STAFF NECESSARY QUALIFICATIONS AS WELL AS ENSURING RESOURCES TO ADDRESS THE FOLLOWING. INCREASE IN NUMBER OF CLINICAL TRIALS AND SITES, INCREASE EXPENSES CONDUCT CLINICAL TRIALS OUTSIDE THE U.S., IMPLEMENTATION OF ELECTRONIC SYSTEM AND CHANGES IN CLINICAL TRIALS OVERSIGHT REQUIREMENTS THAT REQUIRE AN INCREASE IN -- INCREASE IN STAFF TRAINING. THE RNC CLINICAL TRIALS WILL BE RECOMPETED IN FY 21 UNDER THE FUNDING MECHANISM OF NL 1 FOR DURATION OF SEVEN YEARS. ONE OR MORE -- ONE AWARD AT THAT TIME. I WILL BE HAPPY TO TAKE ANY QUESTIONS AT THIS TIME. >> DO YOU HAVE ANY COMMENTS OR QUESTIONS? OKAY. I THINK WE WILL MOVE ON THEN. JANET DALE WILL BE PRESENTING A CONTRACT CONCEPT CLEARANCE FOR CLINICAL SITE MONITORING. >> SO THIS IS JANET. I CAN'T SHARE MY SLIDES UNTIL -- THERE WE GO. IT SAYS I CAN'T START SHARING WITH THE OTHER PARTICIPANTS SHARING. THANK YOU. OKAY. SO I GUESS YOU HAVE BEEN ALREADY BEEN TOLL I'M JANET DALE, CLINICAL RESEARCH OPERATIONS PROGRAM, THIS IS FISCAL YEAR 2022 INITIATIVE OF THE NIAID DAIT CLINICAL SITE MONITORING CENTER. SO THIS AWARD, THE CURRENT ONE WAS AWARDED IN 2011 FISCAL YEAR 2011, ONE CONTRACT AWARDED FOR TEN YEARS AS A BASE YEAR PLUS THE OPTION OF NINE ADDITIONAL YEARS. THIS IS A CRITICAL INFRASTRUCTURE AWARD CONTRACT, IT ASSISTS DAIT IN FULFILLING RESPONSIBILITIES AS THE SPONSOR FOR CLINICAL TRIALS AND WHEN WARRANTED THE OVERSIGHT MANAGEMENT OF OTHER FUNDED TRIALS ENSURING THE SAFETY OF STUDY PARTICIPANTS MAINTAINING DATA AND OVERALL STUDY INTEGRITY OF DAIT SUPPORTED NETWORKS AND CLINICAL TRIALS AND PROVIDING ESSENTIAL AGAIN OPERATIONAL SUPPORT TO MAJOR DAIT CLINICAL PROGRAMS. THEY ALSO THROUGHOUT THIS PROCESS ARE EXPECTED AND HAVE THE VERY SUCCESSFUL DEVELOPING AND EFFECT AND MAINTAINING AN EFFECTIVE QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH WHAT YOU KNOW I THINK EVERYONE HERE INVOLVED WITH CLINICAL TRIALS CONSISTENT WITH THE INTERNATIONAL COUNCIL FOR HARMONIZATION GUIDELINE FOR GCP OTHERWISE KNOWN AS ICHE 6R 2. YOUR INVOLVEMENT INFORMS YOU AS YOU ALREADY KNOW THAT DAIT HAS UNIFYING THEME ACROSS DAIT PROGRAMS, IS THIS RELATES TO APPLYING PROMISING TOLERANCE INDUCTIONS STRATEGIES TO THE TREATMENT OF IMMUNE MEDIATED DISEASES AND TRANSPLANTATION. THERE ARE THE TRIAL DESIGNS ARE COMPLEX AND THE THERE IS A DIVERSEANGE OF DISEASES. AND INTERVENTIONAL APPROACHES. WHAT YOU SEE HERE ARE THE -- OOPS I'M SORRY. DOESN'T MATTER. WHAT YOU SEE HERE ARE THE IMMUNE MEDIATED DISEASES ASTHMA ALLERGIC DISEASES AUTO IMMUNE DISORDERS, WHICH THERE ARE MANY. AND IMMUNE MEDIATED REJECTION AND SOLID ORGAN TISSUE AND CELL TRANSPLANTATION THAT IS THE FOCUS. THE DAIT PROGRAMS THAT HAVE BEEN INCLUDED THAT ARE INCLUDED MANY THE COVERAGE OF THIS SITE MONIRING AWARD ARE IMMUNE TOLERANCE NETWORK YOU KNOW TO BE THE LARGEST NETWORK THAT SPANS ACROSS ALL THE DIFFERENT PROGRAMS WITHIN DAIT, THE ASTHMA ALLERGIC DISEASES COOPERATIVE RESEARCH CENTERS AADRC. AND NOT NON-NETWORK CLINICAL TRIALS ON AS NEEDED BASIS. THE MAJORITY OF CLINICAL SITE LOCATIONS ARE IN THE UNITED STATES, HOWEVER, THERE IS A NEED FOR INTERNATIONAL COVERAGE AS YOU CAN SEE HERE PRIMARILY IN EUROPE AND CANADA BUT IT CAN BE BROADER THAN THAT AND THE CONTINUED NEED FOR INTERNATIONAL COVERAGE AS WELL WILL CONTINUE. IN ANY GIVEN YEAR THIS IS AN EXAMPLE OF THE ACCOMPLISHMENTS. THIS WAS THE MOST RECENT YEAR BUT IT COULD BE ANY. WE COVER ANY CLINICAL TRIALS FROM PHASE 0 TO 4. WHAT YOU SEE HERE IS IN ANY GIVEN YEAR THERE'S 30 RESEARCH STUDIES INVOLVING ADULTS AND PEDIATRICS. THE MAJORITY ARE CLINICAL TRIALS, MAJORITY ARE PHASE 1, 2 OR 2. IN ADDITION TO ADDITIONAL OBSERVATIONAL STUDIES WHEN NEEDED TO BE COVERED BY SITE MONITORING. THERE ARE GENERALLY IN A GIVEN YEAR 128 CLINICAL RESEARCH SITES. 230 SITE MONITORING VISITS. HERE YOU SEE THE RISK BASED MONITORING LEVEL AND YOU SEE THE MAJORITY OF OUR TRIALS ARE ARE MEDIUM OR MEDIUM HIGH AS DEFINED BY RISK BASED MONITORING. THIS IS RECOMPETITION, IT WILL CONTINUE TO BE A CONTRACT IN A ONE DURATION OF SEVEN YEARS AND ANTICIPATED ONE AWARD. WE WILL BE EXPANDING WHAT IS INCLUDED AS RELATES TO OUR NETWORKS HERE YOU SEE FIVE ADDITIONAL NETWORKS, ESSENTIALLY THE PLAN IS TO HAVE ONE AWARD TO COVER OUR SITE MONITORING NEEDS. THAT IS FOR PURPOSES OF EFFICIENCY AND EFFECTIVENESS AND MANAGEME AS WELL AS PLANNING AND CONDUCT. AND I WILL BE PLAID TO ANSWER ANY QUESTIONS. >> THANK YOU. >> WHY IS THIS AN EXTERNAL -- (INAUDIBLE)? >> I'M SORRY, I CAN'T HEAR YOU. YOU ARE BREAKING UP, DR. JENKINS. WHY IS IT EXTERNAL? >> WHY IS THIS AN EXTERNAL -- EXTRAMURAL PROGRAM? >> IT IS A CONTRACT -- IT IS A CONTRACT TO COVER OUR SITE MONITORING NEEDS INDEPENDENT OF THE SITES AND OURSELVES. THIS IS LONG STANDING, THE FIRST AWARD WAS IN 2004. WE DON'T HAVE AS YOU KNOW THROUGH THE DRMC AND OTHER INFRASTRUCTURE WE NEED THE INFRASTRUCTURE AS RELATES TO OUTSIDE SOURCES WHO ARE EXPERTS, THEY COLLABORATE WITH US BUT WE RELY UPON THE CONTRACT TO PROVIDE THE SERVICES NECESSARY SERVICES WITH QUALIFIED STAFF. >> MARK, DOES THAT ANSWER YOUR QUESTION OR WAS YOUR QUESTION WAS THIS NOT A RESPONSIBILITY OF DAIT STAFF PER SE OR ONE OF OUR DATA COORDINATING CENTERS OR REGULATORY CONTRACT? >> MORE ALONG THOSE LINES, SEEMS LIKE YOU CAN DO THIS INTRAMURALLY H. >> WE ARE CERTAINLY NOT STAFFED OURSELVES TO HANDLE THE AMOUNT OF TRAVEL INVOLVED IN ALL THE SITES MONITORING. MORE DO WE NECESSARILY HAVE STAFF WITH FULL SET OF EXPERTISE TO DO THIS. SO THAT MAY ANSWER PART OF YOUR QUESTION. THERE ARE MANY EXAMPLES OF DATA COORDINATEK CENTERS AND THE LIKE THAT HAVE THIS FUNCTION AS WELL. BUT FOR US TO HAVE THE BEST CHANCES OF AWARDING A CONTRACTED TO A DATA COORDINATING CENTER WITH MOST RELEVANCE EXPERTISE FOR DATA COORDINATION, AND MONITORING CONTRACT WITH THE RELEVANT EXPERTISE FOR MONITORING. SEPARATING THE TWO MAKES SENSE. >> QUESTION ABOUT THE CURRENT PROJECT THAT'S I GUESS ONGOING, HOW HAS IT BEEN EFFECTIVE BY COVID? I'M ASSUMING IT'S BEEN QUITE DISRUPTED AND IS THERE A NEED FOR COST EXTENSIONS OR WAS THERE A LOSS OF DATA COORDINATION THAT CREATED A PROBLEM?% >> THERE'S BEEN HUGE DISRUPTION AS YOU CAN IMAGINE. SITES WERE NOT THE PRIORITIES FOR COVID-19 NOR WERE THEY ALLOWING MONITORS TO GO ON SITE IN ADDITION THE ENTIRE ENROLLMENT OF MANY TRIALS WAS DISRUPTED. THIS CURRENT AWARD VERY QUICKLY ESTABLISHED A PLAN B DURING THIS TIME WHEN WE CANNOT GET ON TO THE SITE OR THEY CANNOT GET ON TO THE SITE IN TERMS OF KEEPING SITES ENGAGED, SCHEDULING REMOTE MONIRING VISITS AND KEEPING THEM -- IDENTIFYING THIS DEFICIENCIES AND MAINTAINING THE PROCESS UNTIL SUCH TIME WE CAN GET -- THEY CAN GET BACK ON SITED. YOU ARE ABSOLUTELY RIGHT. IT HAS REQUIRED MITIGATION PLANS AND THOSE HAVE GONE VERY WELL. VERY AT THIS RUNTIVE. >> GWEN, TO ADDRESS -- DISRUPTIVE. >> TO ADDRESS THE OTHER PART OF YOUR QUESTION, THE NEED FOR NO COST EXTENSIONSES MAY APPLY MORE TO THE CLINICAL TRIAL NETWORKS THEMSELVES THAN MONITORING CONTRACTOR. WE CAN PRESUMABLY AWARD A NEW MONITORING CONTRACT ON SCHEDULE BUT THE DISRUPTIONS OF THE CLINICAL TRIALS ARE SO SIGNIFICANT THAT IN SOME CASES PARTICIPANTS WHO HAVE GONE OFF IMMUNOSUPPRESSION FOR EXAMPLE, STUDIES EVEN WITH PROTOCOLTHOSE AMENDMENTS, WE MIGHT HAVE TO RECRUIT NEW PATIENTS OR IN OTHER CASES JUST RESTART PATIENTS ON WHATEVER THE PROTOCOL DIRECTOR THERAPY WAS. IT'S A TRIAL BY TRIAL AND IN SOME CASES SITE BY SITE. ISSUE. WE'LL HAVE TO WORK THAT OUT. OVER THE NEXT FEW YEARS. OBVIOUSLY THE CLINICAL TRIAL NETWORK ARE STAGGERED IN THEIR ANNIVERSARY DATES SO SOME MAY BE IMPACTED WITH EARLY ANNIVERSARY DATES, OTHERS THAT HAVE ANNIVERSARY DATES FURTHER OUT MAY BE ABLE TO MAKE ADJUSTMENTS. >> FIRST AND FOREMOST IS HEALTH AND WELL BEING AND CONTINUITY WITH PATIENTS, PARTICIPANTS. >> I GUESS THERE ARE NO MORE QUESTIONS ON THE MONITORING CENTER. THAT BRINGS US TO THE NEXT PRESENTATION JANET, YOU SHOULD PULL YOUR SLIDES OFF SO THAT MERCY CAN GET HER SLIDES UP. THAT PRESENTATION WILL BE BY MERCY PRABHUDAS WHO WILL TALK ABOUT INITIATIVE CALLED IMMUNE DEVELOPMENT IN EARLY LIFE. >> CAN YOU SEE THE SLIDES? >> NOT YET. HERE THEY ARE. GREAT. >> THE PROGRAM I'M SPEAKING TO YOU TODAY IS IMMUNE DEVELOPMENT IN EARLY LIFE. AND THE MAIN OBJECTIVES OF THIS PROGRAM ARE TO UNDERSTAND IMMUNE ONTOGENY FROM BIRTH TO ADOLESCENCE WHICH INCLUDES ELUCIDATING MECHANISM Z AS WELL AS PATHWAYS AND IMMUNE SIGNATURES ASSOCIATED WITH THE DEVELOPMENT OF A FUNCTIONAL IMMUNE SYSTEM. AND ALSO LIKE TO DEFINE IMMUNE MECHANISMS THAT REGULATE THE INDUCTIONS AND MAINTENANCE OF PROTECTIVE IMMUNITY IN BIRTH FROM BIRTH THROUGH ADOLESCENCE. TO INFECTIONS INCLUDING HIV OR VACCINES AND ENVIRONMENTAL -- >> MERCY, THIS IS YOUR SLIDES AREN'T GOING FORWARD. >> PUT IT ON SLIDE. THANK YOU. >> ONE SECOND. SORRY. >> IS THAT BETTER? >> PERFECT. THANK YOU. >> SORRY. GREAT. ARE WE BASICALLY WANT TO UNDERSTAND THE IMMUNE MECHANISMS THAT ARE INVOLVED IN THE DEVELOPMENT OF THE IMMUNE SYSTEM FROM BIRTH THROUGH AD HE IS SENSE AS WELL A Z TO LOOK AT REGULATING THE INDUCTIONS AND MAINTENANCE OF PROTECTIVE IMMUNITY FROM BIRTH TO ADOLESCENCE THROUGH INFECTION WHICH INCLUDE HIV FOR VACCINES ENVIRONMENTAL POLLUTANTS ALLERGENS. ONE SECOND. LET ME GET THE NEXT ONE. THIS PROGRAM BEGAN IN 2012 AS THE INFANT IMMUNITY PROGRAM. WHICH CONSISTED OF RO1 BASED PROJECTS, DMID PARTNERED WITH US, THIS PROGRAM, THERE WERE 15 PROJECTS, AND APPROXIMATELY 140 PAPERS RESULTED FROM THIS PROGRAM. IN 2017, IN FY 2017 IT WAS RENEWED AND RENAMED IMMUNITY AND NEONATESES AN INFANTS. PARTNERS AT THIS TIME WERE DMID, DADES NICHD AND NIEHS, CHILD HEALTH DEVELOPMENT INSTITUTE AS WELL AS ENVIRONMENTAL HEALTH INSTITUTE. SO 15 PROJECTS WERE AWARDED AND CURRENTLY THERE ARE AROUND 50 PAPERS. SO JUST HIGHLIGHT A FEW FINDINGS FROM SOME OF THE PUBLICATIONS THAT RESULTED FROM THIS PROGRAM, A STUDY FROM ONE -- FROM ONE OF THE PROJECT SECTORS SHOWED THAT MATERNAL DINGHY VIRUS ANTIBODIES INCREASED CITY CAVIARS INFECTION. PLACENTAL MACROPHAGES. THAT WAS FROM EMORY HE DISCOVERED THE POOL IS A VERY HETERO GENIUS POOL THAT EXPLAINS DIFFERENTIAL RESPONSES THAT ARE SEEN IN EFFECTIVE MEMORY T-CELL SUBJECTS. THEN ANOTHER STUDY IDENTIFIED DIFFERENT SITES IN SMALL INTESTINE OF YOUNG DONORS AND WHICH CONTAIN HIGH FREQUENCIES OF NAIVE T-CELLS AND REGULATORY T-CELLS WHICH REGULATED THE RESPONSES TO ANTIGENS INTRODUCED VIA THE ORAL ROUTE. FROM DONNA'S LAB. FINALLY ONE OF THE STUDIES BASICALLY LOOKED AT LATE ONSET SEPSIS, COHORT STUDIES HAVE OBSERVED THOSE -- THAT REDUCED RISK OF LATE ONSET SEPSIS WAS ASSOCIATED WITH BREAST FED INFANTS WHERE MECHANISMS WERE NOT KNOWN. SOFT THE LAB DEVELOPED AN ANIMAL LAB WITH NEONATAL LATE ONSET SEPSIS AND IDENTIFIED A MECHANISM WHEREBY EGF FROM THE MOTHER WITHIN THE INTESTINAL TRACK OF THE BABY INHIBITED EQUAL ACCESS TO THE CIRCULATION FROM THE COLON. SO WE ARE GOING TO BE EXPANDING THE PROGRAMS INTO THIS NEW PROGRAM CALLED IDEAL, IMMUNE DEVELOPMENT IN EARLY LIFE. HERE WE WOULD LIKE TO SUSTAIN AND EXPAND CURRENT OBJECTIVES AND SUPPORT FOUNDATIONAL STUDIES TO UNDERSTAND PERTURBATIONS IN EARLY LIFE THAT IN FACT IMMUNE DEVELOPMENT AND FUNCTION. WE ALSO WANT TO FOSTER COMPLIMENTATION OF HUMAN AND ANIMAL STUDIES. AND WE ALSO LIKE TO IDENTIFY FACTORS OF EARLY IMMUNE DEVELOPMENT WHICH INFLUENCE SUSCEPTIBILITY TO DISEASES THROUGH CHILDHOOD AND ADOLESCENCE. SO WE ARE INCREASING AND EXTENDING THE AGE RANGE FROM BIRTH THROUGH 18 YEARS -- 18 YEARS OF AGE AND WE ALSO LIKE FOLKS TO LEVERAGE CURRENTLY AVAILABLE COHORTS. FOR THIS RECOMPETITION WE WILL BE USING UO 1 MECHANISM AS WELL AS U 19 MECHANISM AND WE HAVE -- IT WILL BE A FIVE YEAR PROGRAM, WE HOPE TO HAVE AROUND 6 TO 10 PROJECTS FUNDED. THE DIVISION OF AIDS, CHILD HEALTH INSTITUTE, AS WELL AS THE ENVIRONMENTAL HEALTH INSTITUTE WILL BE PARTNERING WITH US. WITH THAT I'M OPEN TO ANY QUESTIONS. >> DO WE HAVE ANY QUESTIONS OR COMMENTS? >> MERCY, THIS IS ADELINA, WHAT IS APPLICATION DATE FOR THIS? >> WE DON'T KNOW, FY 21 SOMETIME. Z SO THIS IS AN FY 22 PROGRAM SO IT WILL COME UP SOMETIME IN FY 21. >> OKAY. THANYOU. >> IF NO QUESTIONS, MERCY YOU SHOULD GO TO THE NEXT PROGRAM UNDERSTANDING INFLUENZA IMMUNITY. THIS PROGRAM IS GOING TO BE LOOKING AT COHORT STUDIES TO IMPROVE UNDERSTANDING OF INFLUENZA IMMUNITY. VCCINE RESPONSES AND EFFECTIVENESS IN OLDER ADULTS OVER 65. THIS IS A JOINT PARTNERSHIP BETWEEN DMID AND DAIT AND MIKE COOPER FROM DMID IS MY COLLEAGUE WHO IS PARTNERING WITH ME ON THIS PROGRAM. SO JT A SHORT BACKGROUND, THAT INDIVIDUALS OVER AGE 65 HAVE HIGHEST INCIDENCE OF SEVERE INFLUENZA INFECTION. AND INFLUENZA RELATED COMPLICATIONS THAT LEAD TO HOSPITALIZATIONS AND DEATH. IT'S THE FOURTH LEADING CAUSE OF DEATH IN AMERICANS. VACCINE EFFICACY ESTIMATES VARY FOR OLDER ADULTS AND IT'S USUALLY LOW IN GENERAL, CURRENTLY WE HAVE THE HIGH DOSE VACCINE OPTION WITH ADJUVANTED VACCINE OPTION AVAILABLE FOR THE ELDERLY. SOME OF THE CURRENT KNOWLEDGE GAPS THAT WE ARE ADDRESSING THE IMMUNE MECHANISMS THAT ARE ASSOCIATED WITH VACCINE FAILURE ARE NOT COMPLETELY KNOWN. ANOTHER ASPECT IS IMPACT OF REPEATED INFLUENZA VACCINATIONS OR NATURAL EXPOSURES ON IMMUNE RESPONSE AND VACCINE EFFICACY. AND INTERSEASON WANING OF RESPONSES AND PROTECTION WITHIN THE SINGLE FLU SEASON THOSE MECHANISMS ARE KNOWN EITHER AND IDENTIFICATION OF CORRELATES OF PROTTION OR RISK. CURRENT OVERALL KNOWLEDGE GAPS. CURRENTLY NIAID SUPPORTS AROUND SEVEN STUDIES THAT INVESTIGATE VACCINE RESPONSES AND -- IN THE POPULATION THAT ARE 65 YEARS OR OLDER. DEALING WITH DEFINING IMMUNE FACTORS THAT ARE ASSOCIATED WITH VACCINE FAILURE. OR CORRELATES OF PROTECTION OR RISK. AND SOME EVALUATING VACCINE RESPONSE BY VACCINE TYPE. FOR EXAMPLE HIGH DOSE VSUS ADJUVANTED VACCINE. THE AGING INSTITUTE SUPPORT STUDIES COMPARING HIGH DOSE HIGH DOSE VACCINE VERSUS STANDARD DOSE VACCINE IN ADULTS LONG TERM CARE FACILITIES AND ANOTHER GROUP IDENTIFYING SEX DIFFERENCES IN B CELL ANTIBODY RESPONSES TO HIGH DOSE VACCINES. IN THE FRAIL ELDERLY. THIS IS A NEW INITIATIVE AND THE GOAL IS TO SUPPORT THE USE OF LONGITUDINAL COHORTS TO DEFINE IMPORTANT ELEMENTS OF INFLUENZA IMMUNITY WHICH IMPACT VACCINE RESPONSES AND EFFICACY IN OLDER ADULTS. THIS ADDRESSES GAP AREAS INCLUDED IN NIAID STRATEGIC PLAN FOR UNIVERSAL FLU VACCINE AND IT WILL SUPPORT STUDIES IN BOTH DOMESTIC AND INTERNATIONAL COHORTS. IT WILL BE A UO 1 COOPERATIVE AGREEMENT, IT WILL BE A FIVE YEAR AWARD. AND WE HOPE TO HAVE TWO TO FOUR AWARDS UNDER THIS PROGRAM AND AS STATED EARLIER IT WILL BE A DAIT AND DMID COLLABORATION. WITH THAT I'M OPEN TO TAKING ANY QUESTIONS. >> THERE IS A QUESTION FROM MARK ABOUT ELIGIBILITY OF MOUSE STUDIES. >> WE WANT TO KEEP THIS ALL HUMAN AS THIS STAGE BECAUSE SOME OF THE AGES IN MICE MAY NOT DIRECTLY BE COMPARABLE TO HUMANS AND SO WE WANTED TO LOOK AT THE VACCINE RESPONSES AND INFECTION RESPONSES IN HUMANS TO -- BECAUSE SOME STRAINS ARE NOT AS RECAPITULATED AS MOUSE MODEL FOR EXAMPLE SO THAT'S WHY WE WANT TO KEEP THIS COMPLETELY IN HUMANS. >> ANY OTHER QUESTIONS OR COMMENTS? IF NOT THEN LET'S MOVE ON TO THE FINAL INITIATIVE. MERCY, YOU HAVE TAKEN YOUR SLIDES DOWN, I GUESS. >> YEAH. >> THAT IS A PROGRAM ON ADJUVANT COMPARISONS AND CHARACTERIZATIONS. HALONNA KELLY WILL DO THE PRESENTATION. HALONNA, WE CAN SEE YOU AND YOUR SLIDES ARE -- PUT THEM IN PRESENTATION MODE SO THAT YOU ARE ABLE TO ADVANCE THEM. >> CAN EVERYONE SEE MY SLIDES? >> YES. >> GREAT. THANK YOU. SO GOOD AFTERNOON, AGAIN MY NAME IS HALONNA KELLY, I'M PRESENTING THE CONCEPT CLEARANCE FOR THE TRANS-NIAID AN EVENTUAL COMPARISON AND CHARACTERIZATIONS PROGRAM, THE ACC PROGRAM. THIS INITIATIVE IS SUPPORT BY ALL THREE DIVISIONS OF NIAID THE DIVISION OF MICROBIOLOGY AN DIVISION OF AIDS. SO I'M FIRST GOING TO WALK YOU THROUGH THE HISTORY OF UP DAIT'S ADJUVANT PORTFOLIO SO THEY HAVE BEEN FUNDING ADJUVANT RESEARCHES IN THE LARGE SCALE STARTING IN 2003. WITH OUR ADJUVANT DISCOVERY PROGRAMS, SEVERAL YEARS LATER WE STARTED SUPPORTING THE ADJUVANT DEVELOPMENT PROGRAM AND MORE RECENTLY WE IMPLEMENTED THE MOLECULAR MECHANISMS OF COMBINATION ADJUVANT PROGRAMS. ADDITIONALLY AROUND THE SAME TIME OF THE MOLECULAR MECHANISMS OF COMBINATION ADJUVANT PROGRAM, WE THOUGHT THAT WE SHOULD BE LEVERAGING THE ADJUVANT DISCOVERY AND DEVELOPMENT WITHIN THE SMALL BUSINESS COMMUNITY SO WE STARTED FUNDING SBIR. THROUGHOUT THIS TIME WE HAVE BEEN FUNDING ADJUVANT RESEARCH LIEU OUR UNSOLICITED GRANT PORTFOLIO. OVER THE YEARS AS WE AMASS DATA THROUGH THESE PROGRAMS, IT BECAME A CHALLENGE TO COMPARE DATA FROM ONE ADJUVANT TO DATA FROM ANOTHER ADJUVANT. THIS IS BECAUSE THEY WERE DIFFERENCES IN MODEL ANTIGENS USED DIFFERENT READ OUTS AND EMPERIMENTAL DESIGNS, ET CETERA. THIS REALIZATION REALLY BECAME FOUNDATION FOR ADJUVANT COMPARISON AND CHARACTERIZATIONS PROGRAM. SO THE OVERALL GOAL OF THE ACC IS TO PROVIDE COMPREHENSIVE SIDE BY SIDE CHARACTERIZATIONS OF MULTIPLE ADJUVANTS TO INFORM SELECTION OF ADJUVANTS FOR VACCINES AND IMMUNE BASED THERAPEUTICSICS. THOUGH I HAVE WRITTEN THE SCOPE HERE I'M GOING TO MOVE TO THE NEXT SLIDE WHERE I HAVE A PICTURE OF THE STRUCTURE OF THE PROGRAM. SO EACH CONTRACT WILL BE COMPRISED OF TWO RESEARCH AREAS, RESEARCH AREA ONE, WHICH IS THE BROAD IMMUNOPROFILING OF ADJUVANT TO BE COMPARED AND RESEARCH AREAS TO WHICH IS THE FOR RESEARCH AREA ONE THE OFFERER CAN PROPOSE CAN COMPARE UP TO FIVE ADJUVANTS, THEY MUST ALSO INCLUDE REFERENCE ADJUVANTS SUCH AS ALUM AND ADIVAKS AND WE ARE ASKING THE OFFERER TO ACCOMMODATE THE INFLUENCE OF UP TO FIVE ADJUVANTS APPOINTED BY NIAID BASED ON OUR RESEARCH PRIORITIES. SO FOR RESEARCH AREA ONE, THE OFFERER CAN PROPOSE TO COMPARE ADJUVANTS USING UP TO THREE PLATFORMS AND BY PLATFORMS WE MEAN MODEL ANT ENGINE THE OFFERER PLANS TO USE IN COPY NATION WITH ADJUVANTS SO THIS ANTIGENS CAN BE FROM A VIRUS BACTERIA, EUKARYOT ORGANISM OR IMMUNE MEDIATED DISEASE. SO BASED ON EACH PLATFORM THE OFFER HAS TO PROVIDE BROAD IMMUNOPROFILING LOOKING AT INNATE CELLS, T-CELLS, B CELLS AND ANTIBODIES. FROM THERE USING THE LEAD ADJUVANTS, THAT PROPOSE UP TO THREE CHALLENGE MODELS AND AGAIN LOOKING AT INNATE CELL PROFILE T-CELL PROFILE AND ANTIBODY PROFILE AND TRYING TO DETERMINE WHETHER OR NOT THESE IMMUNOPROFILES CORRELATE WITH DISEASE OUTCOMES. I'M SORRY IF I FAILED TO MENTION RESEARCH AREA ONE WOULD BE DONE IN AN ANIMAL MODEL OF OFFERERS CHOOSING. OBVIOUSLY THE CHALLENGE MODEL WOULD BE DONE IN ANIMAL MODEL AS WELL. ALL THE DATA WOULD BE PROVIDED TO THE SCIENTIFIC COMMUNITY. SO FOR THIS INITIATIVE WE ARE PROPOSING THE CONTRACT MECHANISM TO GIVE US THE FLEXIBILITY OF ADDING ADJUVANTS OF OUR CHOOSING, THESE CLINICAL TRIALS ARE UP TO FIVE YEARS AND THROUGH THE CO-SPONSORSHIP OF DAIT AND DMID WE HOPE TO FUND UP TO FOUR CLINICAL TRIALS. THAT'S IT. ANY QUESTIONS? >> MAYBE I WOULD LIKE -- THIS IS GAY WEB TO ASK A QUESTION ABOUT PROVIDING THE DATA TO THE COMMUNITY. WHAT IS THE MECHANISM THAT YOU YOU TYPICALLY DO HERE OUTSIDE OF PUBLICATION. >> WE HAVEN'T FLUSHED THAT OUT YET BASED ON IP ISSUES ET CETERA SO THAT'S STILL KIND OF SOMETHING THAT WILL NEED TO DSCUSS. ONE THING WE WANT TO CHIME IN A LITTLE BIT MORE BECAUSE HE ISLETEDDING THESE ADJUVANTS FOR A VERY LONG TIME. BUT THE IDEA IS TO PROVIDE SOME LEVEL OF RESEARCH, MAYBE OR HOPEFULLY FOR I DON'T KNOW. THAT'S OUTSIDE OF PUBLICATIONS TO THE SCIENTIFIC COMMUNITY. AGAIN WE WANT TO BE ABLE TO ALLOW INVESTIGATORS TO UNDERSTAND HOW THEY CAN BE -- HOW THEY SHOULD BE SELECTING THESE VARIOUS ADJUVANTS AND WHY. >> THIS IS ALLISON. SO WOLF GANG IS WORKING WITH OUR OFFICE OF SCIENCE TECHNOLOGY INSIDE OF NIAID TO DEVELOP A PUBLIC WEB PORTAL TO PROVIDE GENERAL INFORMATION ABOUT THOSE ADJUVANTS. THAT WE HAVE ALREADY BEEN DEVELOPED THROUGH OUR PROGRAM SO WE COULD PUT DATA IN THERE AS WELL SO INVESTIGATORS CAN LEARN MORE ABOUT THE ADJUVANTS THAT ARE BEING TESTED. WE ALSO HAVE THE IMPORT DATABASE SUPPORTED BY DAIT THAT PROVIDES GENERAL INFORMATION ABOUT IMMUNOLOGIC STUDIES CONDUCTED BY DAIT AND OTHER PROGRAMS. WITHIN AN OUTSIDE OF NIAID. I'LL SOP THERE. >> GWEN, DOES THAT ANSWER YOUR QUESTION? >> LOOKS LIKE WOLFGANG IS GETTING READY TO ADD SOMETHING ON. >> YES, I WAS GOING TO SAY WE WERE THINKING OF USING THE IMPORT DATABASE BUT AS ALLISON MENTIONED WE ARE ALSO WORKING ON THE ADJUVANT DATABASE THAT IS HOPEFULLY GOING TO COME ONLINE BY LATER THIS YEAR. THAT WILL ACCOMMODATE A LOT OF THESE DATA COMING OUT OF THIS PROGRAM BUT ALSO PREVIOUS NIAID ADJUVANT PROGRAMS. I ALSO SAW DR. JENKINS ABOUT OTHER ANIMAL MODELS, FERRETS CONTINUE TO BE A CHALLENGE WHEN IT COMES TO DETAILED MECHANISTIC IMMUNOLOGICAL STUDIES BECAUSE OF THE AVAILABILITY OF REAGENTS. WE DO HAVE OTHER PROGRAMS TO SUPPORT THE PRODUCTION OF NEW IMMUNOLOGICAL REAGENTS WITH THESE ANIMAL MODELS. THAT'S A COMPLETELY SEPARATE PROGRAM. >> ONE OTHER THING WE MIGHT CONSIDER PUBLICIZING THE RESULTS WOULD BE ANNOUNCEMENTS IN THE EXTRAMURAL NEWS IT GOES OUT TO MANY, MANY GRANTEES. THERE IS AN UPDATE IN IMPORT OR WHEREVER OR PUBLICATIONS THAT EMERGED FROM THIS WORK AND PROVIDE OTHER LINKS. >> OKAY. ANY OTHER QUESTIONS ON THIS? QUESTIONS ON ANY OF THE INITIATIVES THAT WERE DISCUSSED? IF NOT WE CAN WRA UP IN JUST A FEW MINUTES THEN. WE ARE AHEAD OF SCHEDULE WHICH IS ALWAYS NICE. SHORT PEOPLE HAVE A LOT TO DO P. FORTUNATELY FOR YOUR SCHEDULES YOU DON'T HAVE TO TRAVEL HOME AND YOU CAN FORTUNATELY FOR US I THINK THESE MEETINGS ARE GOING PRETTY WELL BUT WE MUCH RATHER HAVE THEM IN PERSON. I HOPE THAT'S THE CASE BY THE FALL COUNCIL ROUND. I NEED A MOTION TO APPROVE AND THEN A SECOND FROM COUNCIL MEMBERS. NEED SOMETHING IN THE ELECTRONIC COUNCIL FOR EACH OF THESE AS WELL. >> THAT'S CORRECT. I LIKE THE COUNCIL MEMBERS TO ENTER -- GO INTO THE ECB AND APPROVE EACH OF THE CONCEPT CLEARANCES AS WELL AS ISHWAR'S PRESENTATION. HIS CONCEPT CLEARANCE. >> YOU DO NEED THE VERBAL MOTION AND A SECOND? >> THAT IS CORRECT. >> SO MOVED. >> SECOND. >> OKAY. LET ME THEN THANK YOU ALL FOR PARTICIPATING IN THIS UNUSUAL WAY. WISH YOU WELL IN THE NEXT FEW MONTHS. ACTUALLY, I'M CURIOUS TO ASK, HOW MANY OF YOU ARE STILL WORKING FROM HOME OR BECAUSE YOU ARE WORKING ON COVID ESSENTIAL RESEARCHER LABORATORIES IN YOUR OFFICES? SOUNDS LIKE MARK IS IN HIS CABIN. >> WE ARE WORKING FROM HOME. WE ARE ACTUALLY PUTTING TOGETHER A U 19 APPLICATION DUE THIS WEEK. >> UH-HUH. >> AMONG OTHER THINGS. >> >> YOU ARE HOME TODAY TOO. >> I'M ALSO AT HOME, AT WASHINGTON UNIVERSITY OUR LABS RESTARTED TO 30% CAPACITY. BUT WHEN I CALCULATED THAT FROM MY LAB AND MYSELF, I -- SINCE SO MUCH GRANT WRITING AND -- AT HOME I'M GIVING ALL THOSE HOURS. PEOPLE IN THE LAB. EXCEPT MAYBE I HAVE SIX HOURS A WEEK I ALLOWED MYSELF TO BE SCHEDULED. >> AT BRIGHAM AND MASS GENERAL WE HAVE GONE BACK OPENING 50% FOR LABORATORY WORK. BUT THERE'S STILL REQUESTING EVERYONE WHO CAN WORK FROM HOME TO CONTINUE TO DO SO. THE LABORATORY WORKERS ARE GOING BACK BUT FACULTY AND ADMINISTRATORS ARE WORKING FROM HOME. >> WE WOULD BE REOPENING TOO THIS WEEK, LATER THIS WEEK. >> I HOPE OVER THE NEXT FEW WEEKS, BACK TO 100%