I'M KEN FREEBERG AND I WANT TO
WELCOME EVERYONE TODAY.
SEPTEMBER MEETING OF THE AIDS
RESEARCH COMMITTEE OF NIAID AND
WE HAVE A VERY INTERESTING AND
PACKED AGENDA THIS AFTERNOON AND
WE LOOK FORWARD TO HEARING ABOUT
EXCITING NEW SCIENCE BEING
PROPOSED FIRST ORDER OF BUSINESS
IS TRUE AND CONSIDERING APPROVED
THE MINUTES OF OUR JUNE MEETING.
SO I WONDER IF I COULD HAVE A
MOTION TO APPROVE THOSE MINUTES.
>> SO MOVED.
>> SOMEONE SECOND THAT MOTION.
>> WE HAVE SECOND.
>> ALL IN FAVOR OF ACCEPTING
THOSE MINUTES.
>> AYE.
>> ANYONE OPPOSED?
WE WILL APPROVE THE MINUTES OF
THE JUNE MEETING AND THANK YOU,
EVERYONE, I APPRECIATE THAT.
BEFORE I HAPPENED IT OVER TO
Dr. DIEFFENBACH, I WANT TO
TAKE A MOMENT ON BEHALF OF OF
THE AIDS RESEARCH ADVISORY TO
REFLECT AS WHICH OPEN THE
SEPTEMBER TO 22 MEETING WHICH
WILL BE THE LAST MEETING UNDER
THE LEADERSHIP OF ANTHONY FAUCI.
HE HAS LED NIAID SINCE 1984 AND
IT'S REALLY IMPOSSIBLE TO
CAPTURE THE ENORMITY OF HIS
CONTRIBUTIONS AND HIS
EXTRAORDINARY LEADERSHIP OF
NIAID AND THROUGHOUT THE
DIVISION OF AIDS HAS BEEN
UNPARALLEL.
HIS ABILITY TO SEE THE WORLD AND
MAKE IT BETTER HAS BEEN TRULY
ASTONISHING FOR THE MOST
FUNDAMENTAL SCIENTIFIC QUESTIONS
AND TO THE DIFFICULT CLINICAL
PROBLEMS OF OUR LIFETIMES AND TO
THE MANY PUBLIC-HEALTH
CHALLENGES THE WORLD HAS FACED
OVER THE PAST 40 YEARS AND SO
MANY INFECTIOUS AND OTHER
DISEASES.
THEY HAVE PROFOUND LIFE-SAVING
EFFECT ON INDIVIDUALS,
COMMUNITIES AND REALLY ON THE
ENTIRE WORLD.
AND WE, AS A COMMITTEE, WANT TO
THANK HIM ON BEHALF OF PEOPLE
EVERYWHERE AND WE LOOK FORWARD
TO WHAT WILL NO DOUBT BE
CONTINUED EXTRAORDINARY
ACCOMPLISHMENTS AS HE OPENS THE
NEXT CHAPTER.
THANK YOU Dr. ANTHONY, TONY TON
FAUCI.
THANK YOU.
LAND ME AFTER IT OVER TO Dr.
CARL DIEFFENBACH FOR THE
DIRECTOR'S REPORT.
>> I WANT TO THANK YOU KEN FOR
THOSE INCREDIBLY MEANINGFUL
WORDS.
IT'S BEEN A PLEASURE TO BE THE
DIRECTOR OF DIVISION OF AIDS TO
LEAD THE DIVISION SINCE 2008 AND
I THINK WE HAVE APPOINTED
OURSELVES AS WELL AS WE CAN AND
WE CONTINUE TO STRIVE TO MAKE
PROGRESS AGAINST HIV,
SARS-CoV-2, AND NOW MONKEYPOX.
SO, OUR PLATE IS FULL AND WE
WILL CONTINUE TO PUSH FORWARD.
SO, IT'S MY PLEASURE TO WELCOME
YOU TO THE SEPTEMBER MEETING OF
THE AIDS RESEARCH ADVISORY
COMMITTEE AND NEXT SLIDE,
PLEASE.
I WANT TO START BY HONORING
SOMEONE WHO PASSED AWAY AND THE
LAST COUPLE OF WEEKS, NEIL
NATHANSON.
IT'S REALLY IMPORTANT THAT WE
CAN REMEMBER HIM.
I HAD THE PLEASURE OF KNOWING
NEIL WHEN I WAS A GRADUATE
STUDENT AND THE TIME WAS THE
SCHOOL OF HYGIENE AND
PUBLIC-HEALTH AT JOHNS HOPKINS
UNIVERSITY AND WHEN I STARTED
THERE IN 1976 TO WHEN HE THROAT
GO TO PENN IN 1979.
OUR PATHS CROSSED AGAIN YEARS
LATER IN 1998 WHEN HE WAS
APPOINTED DIRECTOR OF THE OFFICE
OF AIDS RESEARCH BY HAROLD
VARMUSS.
AT THAT TIME, HE HAD THIS TO SAA
POWERFUL SCIENTIFIC INTELLECT
GREAT COMPASSION AND LONG
ADMINISTRATIVE EXPERIENCE.
THE TASK TO LEADING THE NIH/AIDS
RESEARCH PROGRAMS AT THIS
CRITICAL TIME.
KEEP IN MIND, WHEN NEIL CAME TO
OAR HE WAS FOLLOWING IN THE
FOOTSTEPS OF BILL PAUL WHO HAD
BEEN BROUGHT INTO HELP IMPLEMENT
THE CHANGES TO OAR AND THE
STRUCTURE OF AIDS RESEARCH
FUNDING THAT BERNIE FIELDS HAD
IDENTIFIED AND PUBLISHED IN THE
MID-90S.
AND HE BUILT STRONGER BRIDGES
BETWEEN THE INSTITUTE AND
CENTERS AND EXPANDING THE ROLE
OF THE INVESTIGATOR COMMUNITY
AND HELPING TO DRAFT THE NIH,
HIV/AIDS STRATEGIC PLAN.
HE WAS ONLY IN THE POSITION FOR
TWO YEARS, HIS CREATIVE AND
POSITIVE INFLUENCE CARRIED
FORWARD AND IS STILL MANY OF HIS
IDEAS ARE STILL IN PLACE TODAY.
I WANTED TO ACKNOWLEDGE KNEEL'S
PASSING SO NEXT SLIDE.
I'M PLEASED TO A NEXT THAT ROBIN
FANFAIR IS JOINING US TODAY AS
AN EX AN EX-OFFICIO MEMBER FILL.
ROBIN IS SERVING AS THE ACTING
DIVISION DIRECTOR AND DIVISION
OF HIV PREVENTION AT CDC AND
PLEASE JOIN ME IN WELCOMING HERE
TODAY AND TO THE ARAC MEETING.
IT'S A PLEASURE TO HAVE YOU WORK
WITH US.
>> THANK YOU SO MUCH FOR THE
WARM WELCOME AND I'M PLEASED TO
BE HERE.
NEXT SLIDE, PLEASE.
I'D LIKE UP TO DATE YOU ON OUR
BUDGET.
THOSE WHO AWE Dr. FAUCI'S
PRESENTATION THIS MORNING HAVE
SEEN THESE SLIDES WHERE HE
TALKED ABOUT WHERE WE WERE IN
FISCAL YEAR 2022 AND WHAT WE'RE
LOOKING AT IS A HOUSE MARK OF A
5.1% INCREASE AND A SENATE MARK
OF A 2% INCREASE.
WE DON'T HAVE A SENSE OF WHERE
WE'LL END UP AT THE END OF THE
DAY.
IMPORTANTLY, THIS IS IN RED AT
THE BOTTOM HERE IS THESE NUMBERS
EXCLUDE THE OAR TRANSFER SO THE
FINAL BUDGET THAT THE DIVISION
OF AIDS WILL HAVE WILL BE FORMED
AFTER THE APPROPRIATIONS BILL
HAS FORMALLY BEEN PASSED.
SO, AS WE DO EVERY YEAR, WHEN WE
KNOW WE'RE STARTING UNDER A
CONTINUING RESOLUTION WE START
AT A VERY CONSERVATIVE POSITION
PLANNING FOR THE WORSE THE AND
HOPING FOR THE BEST.
WE'LL START WITH AN ESTABLISHED
PAYLINE FOR ESTABLISHED
PRINCIPLE INVESTIGATORS OF THE
TENTH PERCENTILE IN UPIs AT
THE 14% STYLE AND THEY WILL
HAVEN'T ANY ADJUSTMENTS AND AT
THIS POINT IN TIME COMPETING
RESEARCH INITIATIVES HAVE BEEN
TENTATIVELY SET FOURTH WITH A
20% CUT IF THIS STAYED AS OUR
FULL FINANCIAL MANAGEMENT PLAN
FOR THE YEAR, WE WOULD HAVE AN
ESTIMATED SUCCESS RATE OF
BETWEEN 18 AND 22%.
NOW, TYPICALLY, WHEN WE GET A
BUDGET, THESE NUMBERS WILL
INCREASE AND HOPEFULLY WE'LL
HAVE THAT EARLY IN THE FISCAL
YEAR AS WE GO FORWARD.
SO, ONE OF THE THINGS WE TALKED
ABOUT AT THE MOST RECENT MEETING
WAS DIVERSITY, EQUITY, INCLUSION
AND ACCESSIBILITY AND LIKE Dr.
FAUCI TALKED ABOUT TODAY, I HAD
MADE A PLEDGE TO BE AT THE
DIVISION WAS GOING TO PUT DEAI
CONSIDERATIONS AS PART THE OF
EVERY FUNDING ACTION AND
EVERYTHING THAT WE'RE
CONSIDERING AS WE GO FORWARD IN
OUR RESEARCH PLAN.
I ALSO SAID I WOULD COME TO YOU
AT EVERY MEETING AND TALK ABOUT
WHAT WE HAVE DONE OR WHAT WE ARE
DOING IN THE AREA OF HIGH VERSE
TEE, EQUITY AND INCLUSION AND
THIS IS THE FIRST ARAC MEETING.
I THOUGHT I WOULD HIGHLIGHT A
COUPLE OF ACTIVITIES THAT ARE ON
GOING AND SOME NEW THINGS THAT
WE'RE STARTING AND LOOK AT THEM
THROUGH THE LENS ABOUT HOW THEY
HAVE HAD AN IMPACT AND SOME OF
THESE THINGS HAVE BEEN GOING FOR
O.P.P. FOR A WHILE AND THIS IS
NOT A FAD THAT WE HAVE SUDDENLY
FOUND.
MANY OF THESE HAVE BEEN GOING ON
FOR A REL
RELATIVITY LONG PERIOD OF TIME.
THEY HAD A PROGRAM THAT START
INSIDE 2015 DESIGNED TO FUND
MENTORED TRAINING PROJECTS FOR
DECREASING HEALTH RELATED
DISPARITIES IN THE HISPANIC AND
LATINO COMMUNITY CALLED
ADELANTE.
A NEW PROGRAM ON ITS SECOND
YEAR, THE -- THIS IS A
INTERESTING PROGRAM DESIGNED TO
ENHANCE EXISTING PROGRAMS AND IN
THE DEVELOPMENT OF NEW WITHIN
THE CFAR NETWORK FOR
COLLABORATION WITH HISTORICALLY
BLACK COLLEGES, UNIVERSITIES AND
OTHER MINORITY-SERVING
INSTITUTIONS.
I KNOW THEY ARE INTERESTED AND
COMMITTED TO AND I SEE THIS
PROGRAM GROWING IN IMPORTANCE
OVER TIME.
THE ONE THING ABOUT THIS PROGRAM
THAT'S DIFFERENT THAN OTHER
THINGS WE DO, THIS A LOUSE ALLOO
REACH UNDERGRADUATE AND HIGH
SCHOOL LEVEL TO HELP BRING
FORWARD THE NEXT GENERATION SO
YOU ARE NOT WAITING FOR SOMEONE
TO MATRICULATE IN A MEDICAL
SCHOOL OR GRADUATE SCHOOL BUT
GET THEM AT THE UNDERGRADUATE
LEVEL AND GET THEM INTERESTED IN
AIDS RESEARCH AND INVOLVED IN
AIDS RESEARCH AND GET STEM
STUDENTS AT THE HIGH SCHOOL
LEVEL ENGAGE.
THIS IS A VERY IMPORTANT PROGRAM
AND WE'RE LOOKING FORWARD TO
SEEING IT GROW.
WITHIN THE HIV EPIDEMIC
INITIATIVES, THAT WE HAVE HAD,
FOCUSED ON EQUITY, FOCUSED
APPROACHES TO REDUCE HIV-RELATED
HEALTH DISPARITIES AND THE CYCLE
WE FUNDED 25 PROJECTS AND 18 TO
CFAR AND SEVEN TO THE NIH/AIDS
RESEARCH CENTER SO AGAIN, THIS
IS NOT JUST ABOUT THE DIVISION
BUT ACROSS NIH PROGRAMS
INVOLVING NIMH AS WELL.
IN TERMS OF SOME OTHER
ACTIVITIES, WE HAVE REISSUED A
PROGRAM ANNOUNCEMENT TO
TRANSGENDER PEOPLE, IMMUNITY
TREATMENT AND PREVENTION OF HIV
AND STIs.
THIS REALLY HAP REAL HELPS US UD
THE BIOLOGY AND SCIO BIOLOGY
WITH TRANS PEOPLE AND AS AN
EXAMPLE OF ONE OF THE PROGRAMS
THE NETWORKS ARE SUPPORTING, IS
THE MINORITY HIV INVESTIGATOR
MENTORING PROGRAM AND HAKEEN
INTERNATIONAL INVESTIGATOR
MENTORING PROGRAM WHICH ARE
ADMINISTERED BY THE ACTG UNDER
REPRESENTED POPULATION
COMMITTEES.
THESE PROGRAMS ENGAGE IN
SCIENCES IN THE HIV FIELD.
THERE ARE OTHER NETWORKS WITH
SIMILAR PROGRAMS SUCH AS THE
HPTN SCHOLARS THAT HAVE BEEN
INCREDIBLY POWERFUL IN BRINGING
FORWARD UP-AND-COMING MINORITY
INVESTIGATORS THAT HAVE BEEN
ABLE TO REACH THEIR GOALS FASTER
THROUGH THIS KIND OF
ACCELERATION.
WHAT I'D LIKE TO SPEND A LITTLE
BIT MORE TIME ON TODAY, IS THE
HANK LEGACY PROJECT DEVELOPED
SOMETHING CALLED THE REP RESEN
TIVE STUDIES RUBRIC TO HELP
ENSURE THAT WE ARE MEETING THE
NEEDS OF THE DIVERSE
REPRESENTATION OF PARTICIPANTS
IN OUR CLINICAL SEARCH.
THIS IS MORE ABOUT THE RSR OR
REPRESENTATIVE STUDIES RUBRIC.
THEY WERE ABLE TO GO DOWN TIE
POINT WHERE THEY HAD 12-ITEM
QUESTIONNAIRE AND THAT COULD BE
APPLIED TO STUD OWE PROTOCOLS TO
FACILITATE ENHANCED INCLUSION OF
UNDER REPRESENTED POPULATIONS IN
THE PROTOCOL.
THEY DID IS EXAM INDIVIDUAL
STUDY PROTOCOLS FOR THEIR
REPRESENTATION OF PEOPLE BASED
ON AGE AND ETHNICITY, GENDER,
AND INJECTION DRUG USE,
PREGNANCY RACE, AND SEX ASSIGNED
AT BIRTH.
SO USING THIS RUBRIC, THE
ANALYSIS COVERED 46 NETWORK
STUDIES AND THAT'S COMPLETED IN
2021.
WHAT WE WERE ABLE TO SEE-THROUGH
THIS ANALYSIS, WAS A WIDESPREAD
SYSTEMATIC EXCLUSION OF UNDER
REPRESENTED POPULATIONS AND IT
WAS MOST OFTEN THE GOAL IS TO
DETERMINE HOW BEST TO OPTIMIZE
UNINTENTIONALLY EXCLUDE KEY
POPULATIONS SOME OF THE THINGS
THAT PEOPLE ARE EXCLUDED FOR WE
DON'T NEED TO EXCLUDE IN AN
ININTENTIONAL WAY.
WHERE WE ARE ON OUR COVID
STUDIES.
MANY OF YOU WHO HAVE
PARTICIPATED IN ACTIVE 2D
REALIZE WE'RE IN LONG-TERM
SAFETY FOLLOW-UP IN EFFICACY OF
A SET OF AGENTS, NO NEW AGENTS
HAVE COME INTO ACTIVE 2D AND
IT'SEN ROLLING IN THE UNITED
STATES AND THAT IS LOOKING AT
THE SHINOGI-66662 PROTEASOME
INHIBITOR AND ALL THE COVID-19
STUDIES ARE ENROLLED AND IN
SAFETY FOLLOW-UP OR AT A POINT
NOW WHERE THEY'RE NEARLY
COMPLETED.
AS YOU ARE AWARE, MODERNA mRNA
1273 WAS APPROVED AS A TWO-DOSE
PRIMARY SERIES AND LICENSED 18
AND OVER.
IT RECEIVED EUA APPROVAL AT A
LOWER DOSE FOR SIX MONTHS AND
UP.
AND NOW MORDECHAI BIVALENT BOOST
WHICH INCLUDES THE ANCESTORIAL
AS WELL AS THE OMICRON BA.4/5
HAS RECEIVED AN EUA FOR
INDIVIDUALS 18 AND ABOVE.
IT'S THE EXPECTATION THAT WITHIN
THE NEXT COUPLE OF WEEKS, THE
FDA WILL OR THE CDC WILL MAKE
RECOMMENDATIONS ON EXTENDING THE
AGE FOR THE BIVALENT BOOST.
NOVAVAX HAS BEEN ISSUED FOR THE
PROTEIN, WHICH IS A TWO-DOSE
PRIMARY SERIES AND I KNOW THIS
IS AVAILABLE BECAUSE IN LOOKING
AROUND WHERE I CAN GET MY
BOOSTER THIS WEEKEND, I SAW
PLACES OFFERING THE NOVAVAX
VACCINE AS A PRIMARY SERIES,
WHICH IS GREAT TO SEE.
THE EUA PACKAGE HAS BEEN
SUBMITTED AND FOR IT'S PRIMARY
SERIES AND THERE'S AN INDICATION
WITH A BETA BIVALENT VACCINE.
SO, ONE OF THE THINGS THAT WE
PRIDE OURSELVES ON IS AS WE
DEVELOP TECHNOLOGIES AND WE HAVE
THESE VERY LARGE GRANTS, LIKE
THE IPCMEDs, WE ENCOURAGE
PEOPLE TO SHARE THE INFORMATION
THAT THEY GATHERED AND TO REALLY
HELP ADVANCE SCIENCE.
ONE OF THE THINGS THAT THE DUKE
GROUP HAS DONE, IS THEY HAVE
DEVELOPED SIGNIFICANTLY
PROTOCOLS FOR THE DEVELOPMENT OF
AN mRNA-LNP-TYPE VACCINE AND
HOW TO SHARE IT.
DUKE HAS SHARED WITH WITH
COLLABORATORS AND THE GOAL IS TO
HELP MAKE THE MESSENGER mRNA
TECHNOLOGY A TRUE PLATFORM FOR
RESEARCH AND THEY'RE
COLLABORATING WITH THE NIAID
VACCINE RESEARCH CENTER WITH A
GROUP CALLED AFRIGEN AND A
W.H.O.-mRNA HUB.
WE'RE TRYING TO GET THE
TECHNOLOGY THAT WE'RE DEVELOP
RECOGNIZE MAIN STREAMED IN A WAY
THAT WILL REALLY HELP TO FOSTER
AND SPEED UP DEVELOPMENT OF
SPECIFIC mRNA IN THE FUTURE.
THERE ARE FIVE PILLARS OF
ADDRESSING GAPS AND IMMUNOLOGY
AND UNDERSTANDING TRANSMISSION,
FOSTERING DEVELOPMENT OF NEW
DIAGNOSTICS AND EVALUATING NEW
TREATMENT STRATEGIES AND
EXISTING IN NEW TREATMENT
STRATEGIES AND OPTIMIZING AND
ADVANCING THE VACCINE REGIMENTS.
NEXT SLIDE, PLEASE.
TO THAT END, THE DIVISION OF
AIDS AND THE ACHG, FOR THOSE
THAT SAW TONY'S TALK THIS
MORNING, REALIZED A TRIAL CALLED
A541A OR STUDY OF TECROVIRIMAT
FOR THE TREATMENT OF HUMAN
MONKEYPOX HAS STARTED.
TO VALUE WAIT THE SAFETY AND
ADVOCACY FOR THE TREATMENT OF
HUMAN MONKEYPOX DISEASE.
OBVIOUSLY, WHAT WE ARE SEEKING
IS FASTER CLINICAL RESOLUTION OF
THE POX LESIONS COMPARED TO
PLACEBO.
KEEP IN MIND, THIS IS A 2-1
RANDOMIZATION SO WE'RE REALLY
STACKING THE DECK IN FAVOR OF
GETTING PEOPLE TREATED.
AND WE'RE DOING LOOKING AT TIMED
RESOLUTION AND THE END POINT IS
CLINICAL RESOLUTION IS WHEN ALL
SKIN LESIONS ARE SCABBED OVER
AND ALL ADVISABLE MUCOLAL
LESIONS ARE SCABBED.
THEY'RE GOING TO LOOK AT THE
FRACTIONAL DOSING NEEDED IT'S
IMPORTANT WE GET NOT JUST SAFETY
DATA BUT ALSO SOME P.K. DATA ON
TECOVIRIMAT AND BECAUSE AT THE
OWNED OF THE DAY, WE COULD GET
IN A SITUATION WHERE THIS
DISEASE WAS NOT JUST CONFINED TO
ONE POPULATION.
THIS IS ACTUALLY THREE ARMS.
THE 2/1 RANDOMIZATION.
THERE'S AN INTENSIVE SUB STUDY
LOOKING AT PK. OF 100 PEOPLE IN
THE RANDOMIZED GROUP.
AND YOU CAN SEE THE REST OF THE
DETAILS THERE.
SO ENROLLMENT IS ELIGIBLE DOWN
TO THREE KILOGRAMS SO RELATIVELY
YOUNG CHILDREN WOULD BE
ELIGIBLE.
QUITE YOUNG CHILDREN LIKE THE
TIME OF BIRTH WOULD BE ELIGIBLE
TO PURPOSE IN THE STUDY.
THE PRIMARY OUTCOME IS TIME TO
CLINICAL RESOLUTION AND THE
DURATION OF FOLLOW-UP IS 57 DAYS
AND AS I WAS SAYING THERE'S A
WEIGHT-BASED TECH ROW VERA MAT
PART OF THIS AND IT IS DEALT
WITH IN THE PROTOCOL.
WE ARE SCHEDULED FOR THE JANUARY
MEETING TO BE VIRTUAL AS WELL.
WE ARE IN DISCUSSIONS NOW AS TO
WHETHER WE'RE GOING TO HAVE AN
AVRS MEETING AT THE ASSOCIATED
WITH THE JANUARY MEETING THAT
REMAINS TO BE SEEN.
SO THE SOONEST WE COULD BE
IN-PERSON WOULD BE JUNE 5th OF
2023.
SO S. I'LL STOP THERE AND ANSWER
QUESTIONS.
>> GREAT.
THANK YOU.
THANK YOU, Dr. DIEFFENBACH.
QUESTIONS?
>> THIS IS KEITH.
I HAVE A QUESTION.
YOU TALKED ABOUT THE
REPRESENTATIVE STUDIES RUBRIC
AND IT JUST -- WHAT STRUCK ME IS
THERE'S UNINTENDED EXCLUSION
OCCURRING SO WHAT IS THE PLAN
FOR LESSONS LEARNED HERE AND
GETTING THESE OUT TO EVERYBODY
SO THAT WE CAN ALL MAKE SURE
THAT WE DON'T MAKE THE SAME
MISTAKES?
>> YEAH, SO THAT IS EXACTLY WHAT
IS GOING ON RIGHT NOW.
SO HANK AND OTHERS ARE PILOTING
THIS WITHIN PROTOCOL DEVELOPMENT
WITHIN EVERY NETWORK SO THAT WE
ARE MORE PRECISE IN OUR LANGUAGE
AND AS WE GO FORWARD AND LET IT
OUT OTHER INVESTIGATORS THAT
NEED THIS AS WELL.
IT IS ACTIVELY GOING ON AND
THANK YOU SEATTLE, THANK YOU TO
HANK AND THE LEGACY TEAM FOR
DOING THIS.
>> JUST TO CONFIRM, CARL, YOU
DID SAY EVERY NETWORK UNDER THE
DIVISION OF AIDS WILL BE
INVOLVED WITH DEVELOPING OR
ADHERING TO OUR REASSESSING
THEIR ACCESSIBILITY AND
INCLUSION PRACTICES?
>> YES.
>> OK.
>> I HAVE A NOTE IN THE CHAT
THAT IT SEEMS LIKE MAYBE ONLY
ACTG IS DOING IT TO START AND
THE OTHER ISSUE IS THAT THE
REPRESENTATIVE STUDIES RUBRIC IS
GOING TO PUBLISH THEIR FINDINGS
BUT OUR GOAL IS TO HAVE IT MOVED
TO EVERY NETWORK.
YES, MELISSA.
>> THANK YOU.
>> MONICA --
>> THE PROGRAMS HAVE BEEN
AMAZING AND I REALLY WANTED TO
THANK YOU ALL FOR SUPPORTING IT
BECAUSE CFAR'S WERE NEVER ABLE
TO SUPPORT PEOPLE FROM
UNDERGRADUATE OR MASTER-LEVEL
PROGRAMS AND IT IS STARTING THE
PIPELINE EARLIER AND WE HAVE ONE
OF THESE AND IT IS GOING SO
WHEREON OCTOBER AGENT, FIFTH.
I WANT TO ASK IF DISADVANTAGED
STUDENTS FROM SOCIOECONOMIC
DISADVANTAGED BEYOND RACIAL AND
ETHNIC AND MINORITY STATUS FITS
INTO OUR MISSION IN THE CFAR
PROGRAMS BECAUSE WHEN YOU GET TO
A K, THE SOCIOECONOMIC
DISADVANTAGES DOESN'T COUNT AS
MUCH AS BEING IN THE URM
CATEGORY.
>> AT THE NIH LEVEL WE
CATEGORIZE IT AS A DISADVANTAGED
GROUP AS WELL AND I THINK WE
WILL CONTINUE TO DO SO.
>> OK.
THANK YOU.
AUDRY MAKES THE IMPORTANT POINT
IN THE CHAT IT WOULD BE GREAT TO
THINK ABOUT CHECKLISTS FOR DEIA
AND OTHERS AND OTHER GRANT
SUBMISSIONS.
>> THAT IS OUTSIDE OF OUR
PURVIEW BECAUSE IT'S A NIH
POLICY ISSUE.
>> WE CAN GENERATE IT FROM HERE
AND MOVE --
>> YEAH.
>> OK.
>> I WOULD LIKE TO JUST SAY, WE
HAVE BEEN FLYING UNDER THE RADAR
DOING THESE THINGS, FOR A NUMBER
OF YEARS AND I WOULD LIKE US TO
BE ABLE TO MAKE SURE THAT WE CAN
CONTINUE TO FLY.
I THINK THAT'S OUR GOAL.
>> FAIR ENOUGH.
LET ME ASKED NOTE THAT IT'S
GREAT THE THIRD ARM YOU
MENTIONED IN A 5418 TO GET THAT
INFORMATION FROM THE VERY
BEGINNING IT'S A MAJOR STEP
FORWARD I THINK WITH THE TRIAL.
>> AGREED.
WE CONTINUE NOW WITH THE OFFICE
OF AIDS RESEARCH OAR UPDATE ON
WOMEN'S HEALTH ON HIV ACTIVITIES
IN FISCAL 22 Dr. LESLEY
MARSHAL.
>> CAN YOU HEAR ME?
>> YES.
>> GOOD AFTERNOON, I'M LESLEY
MARSHAL SENIOR SCIENCE ADVISER
FOR WOMEN'S HEALTH AND BIDE OWE
MEDICAL PREVENTION IN THE NIH
OFFICE OF AIDS RESEARCH COMMONLY
REFERRED TO AS NIHIR AND I'M
PLEASED TO BE HERE TODAY TO
PROVIDE YOU AN UPDATE ON NIH/IRI
IN FISCAL YEAR 22 AT THE
INTERSECTION OF WOMEN'S HEALTH
AND HIV/AIDS RESEARCH.
TODAY I'LL PRESENT SOME METRICS
THAT REFLECT TO HIV PANDEMIC AS
IT RELATES TO WOMEN.
AND AN UPDATE ON IMPORTANT NEW
WOMEN'S HEALTH ACTIVITIES AT
NIH.
WE WILL THEN REVIEW AN IMPORTANT
TOPIC, WHAT IS NIH DOING TO
STRENGTHEN THE POSITION OF WOMEN
WITHIN THE HEALTH RESEARCH
WORKFORCE.
IN 2021, 20 MILLION WOMEN AND
GIRLS WERE LIVING WITH HIV.
ABOUT 54% OF ALL PEOPLE LIVING
WITH HIV.
HIV PREVALENCE AMONGST
TRANSGENDER WOMEN IS HIGH WITH A
14-FOLD GREATER RISK OF HIV
ACQUISITION THAN ADULT CISGENDER
WOMEN.
ADOLESCENT GIRLS AND YOUNG WOMEN
WERE TWICE AS LIKELY AS THEIR
PEERS TO BE LIVING WITH HIV AND
SUB SA HER ENTER AFRICA AND
WOMEN LIVING WITH HIV ARE AGING.
AND AGING WOMEN REMAIN AT RISK
FOR HIV.
CDC ANALYSIS REPORTS THAT HIV IS
ON THE RISE AMONG WOMEN 55 YEARS
AND OLDER IN THE U.S. AND IT
HIGHLIGHTS A FUNDAMENTAL GAP IN
UNDERSTANDING ABOUT PREVENTION
AND CONSIDERATIONS ACROSS
LIFESPAN INCLUDING MONKEYPOX.
REGARDING HIV INCIDENTS HALF OF
ALL OF ALL NEW INFECTIONS WERE
AMONG WOMEN BUT THIS IS HEAVILY
RATED AMONGST YOUNG WOMEN IN
EASTERN HALF ACH AVENUE RICKAL.
INCLUDING EXCLUSION FROM
ECONOMIC OPPORTUNITIES, LACK OF
ACCESS TO SECONDARY SCHOOLING
AND GENDER-BASED VIOLENCE.
WOMEN AND GIRLS EXPERIENCE
PHYSICAL OR SEXUAL INTIMATE
PARTNER VIOLENCE ARE 1.5 TIMES
MORE LIKELY TO ACQUIRE HIV.
IMPORTANTLY, RACE OWN
DISCRIMINATION AND HIV STIGMA ON
BARRIERS FOR WOMEN ACCESSING
PREP.
WOMEN AT RISK FOR HIV WILL
SELF-IDENTIFY OR BE IDENTIFIED
BY THEIR HEALTHCARE PROVIDERS
AND TRANSGENDER WOMEN HAVE
LIMITED ENGAGEMENT WITH
HEALTHCARE SERVICES FURTHER
LIMITING EQUITABLE ACCESS TO
PREP.
IN THE U.S., CDC REPORTS THAT
ABOUT 18% OF NEW HIV INFECTIONS
IN 2019 WERE AMONG WOMEN AND 23%
OF ALL PERSONS WITH HIV IN THE
U.S. ARE WOMEN.
PROGRESS TOWARDS EPIDEMIC
CONTROL TARGETS ARE BETTER AMONG
WOMEN OVER ALL ACROSS THE
CASCADE FROM OUR CONSIDERABLY
SOME OPTIMAL FOR RESELECTION
TENSION AND CARE MAKING ON BOARD
TRANSMISSION INEVITABLE.
NEXT SLIDE, PLEASE.
AS HIV EFFECTS GIRLS AND WOMEN
DIFFERENTLY A CROSS THE
LIFESPAN, THE NIH-HIV RESEARCH
AGENDA FOR WOMEN SHOULD BE
TAILORED APPROPRIATELY.
KEY FOCAL AREAS INCLUDE HIV
DURING PREGNANCY AND LACTATION,
EARLY CHILDHOOD CONSEQUENCES OF
HIV EXPOSURE, HIV IN MENOPAUSE,
THE INTERSECTION OF HIV AND
CO-MORBIDITY, IMPLEMENTATION AND
RESEARCH PARTICULARLY ON
PREVENTION, TREATMENT AND
MATERNAL MORBIDITY AND
MORTALITY, GENDER AFFIRMING AND
(INAUDIBLE) HIV CARE FOR
TRANSGENDER PEOPLE AND THE ROLE
OF SEX AND GENDER AND EFFICACY
OF HIV INTERVENTIONS INCLUDING
PREVENTION, TREATMENT AND CURE.
NEXT SLIDE, PLEASE.
-- WITH SCIENCE, HIV TICK MA AND
DISCRIMINATION, CURE, VACCINES
DEVELOPMENT AND MORE AND AS WE
SHIFT TO RESEARCH CONSIDERATIONS
WE'LL BEGIN WITH THE NIH VISION
FOR WOMEN'S HEALTH RESEARCH AND
HOW IT RELATES TO HIV/AIDS.
THE NIH VISION FOR WOMEN'S
HEALTH INCLUDES THREE
PRINCIPLES, INNS INAUGUR INTEGRF
WOMEN'S HEALTH RESEARCH AND
CONSIDER FOR HIV AND CARE WOMEN
SCIENCE CAREER REACHING THEIR
FULL POTENTIAL.
RESEARCH TO IMPROVE WOMEN'S
HEALTH REQUIRES A COMPREHENSIVE
CONSIDERATION OF THE MANY
FACTORS SUCH AS GENDER, AND SEX,
RACE, AND ETHNICITY JUST TO
MENTION A FEW.
THIS FRAMEWORK CAPTURES THESE
INTERNAL AND EXTERNAL FACTORS
AND THEIR INTEGRATION As COULD S
THE LIFE FORCE.
THE STRUCTURE OF NIH AND MAXIMUM
IMPACT OF HIV RESEARCH FOR WOMEN
AND GIRLS.
BOTH THE NIH IR AND THE OFFICE
OF RESEARCH IN WOMEN'S HEALTH
SIT WITHIN THE OFFICE OF THE
DIRECTOR AND THESE OFFICES
COLLABORATE TOGETHER AND ACROSS
OTHER NIH CENTERS AND OFFICES TO
ENSURE SYNERGY AND ADVANCEMENT
OF RESEARCH TOPICS OF INTEREST
FOR WOMEN LIVING WITH AND AT
RISK FOR HIV.
WE'RE NOW GOING TO EXPLORE SOME
IMPORTANT WORK ON DRAWING AT THE
INTERSECTION OF WOMEN'S HEALTH
AND HIV AT THE NIH.
NEXT SLIDE, IN 2021, CONGRESS
REQUESTED AN UPDATE ON AND
FURTHER INVESTMENT IN NIH
EFFORTS RELATED TO WOMEN'S
HEALTH RESEARCH.
WITH A SPECIFIC EMPHASIS ON
RISING MATERNAL MORBIDITY AND
MORTALITY RATES AND RISING RATES
OF CHRONIC, DEBILITATING
CONDITIONS IN WOMEN.
NIH IS ON THE SUB LINES OF THESE
EFFORTS AS DESCRIBED IN THE
COMING SLIDES.
MATERNAL MORBIDITY AND MORTALITY
IS A PUBLIC-HEALTH CRISIS IN THE
UNITED STATES.
WITH AN ESTIMATED 6/10 MATERNAL
DEATHS BEING PREVENTABLE.
DURING 2011 TO 2015 THE U.S. HAD
NEARLY TWICE THE LIVE BIRTH
MATERNAL MORTALITY RATE IN
CANADA AND THE UNITED KINGDOM.
THIS IS EVEN MORE PRONOUNCED
AMONGST WOMEN OF COLOR.
THESE RACIAL AND ETHNIC
DISPARITIES ARE INFLUENCED BY
STRUCTURAL RACISM AND IMPLICIT
BIAS AND RACIALLY BIASED
POLICIES AND PRACTICES.
NEITHER EDUCATION NOR HIGHER
SOCIOECONOMIC STATUS MITIGATE
THE RISKS.
GLOBALLY IN 2021, THERE WERE
1.3 MILLION PREGNANT PEOPLE
LIVING WITH HIV OF WHICH AN
ESTIMATED 81% RECEIVED ANTI
RETRO VIRAL THERAPY TO PREVENT
TRANSMISSION.
ESTIMATING MATERNAL MORTALITY IS
CHALLENGE BECAUSE IT CAN BE
EFFECTED WITH CHANGING POLICIES.
FOR MOST RECENT REPORT FOUND THE
W.H.O. IN 2017 INDICATES THAT
1.2% OF MATERNAL DEATHS GLOBALLY
ARE ESTIMATED TO BE HIV-RELATED.
AND BECAUSE OF CO-MORBIDITY,
PREGNANT WOMEN WITH HIV ARE
LINKED WITH A TWO TO 10 FOLD
INCREASED RISK OF HIV.
OR OF DEATH.
SORRY.
NEXT SLIDE, PLEASE.
IN 2019, NIH INITIATED MATERNAL
MORBIDITY AND MATERNITY EFFORTS
ACROSS THE ORGANIZATION THROUGH
FORMATION OF A ADVISORY CABINET
WITH SEN NER NIH LEADERS AND A
TASK FORCE WITH KEY SUBJECT
MATTER EXPERTS FROM ALL THE
INSTITUTE CENTERS AND OFFICES.
THE NIH RAR DIRECTOR IS A MEMBER
OF THE ADVISORY CABINET AND
MULTIPLE ADVISERS FROM NIH RAR
SCIENCE TEAM SERVE AS MEMBERS OF
THE TASK FORCE.
THE MATERNAL HEALTH AND
PREGNANCY OUTCOMES DIVISION FOR
EVERYONE OR THE IMPROVE
INITIATIVE, WAS THE FIRST
DELIVERED ON THIS FORCE.
IT SUPPORTS RESEARCH FOCUSED ON
REDUCING PREVENTABLE CAUSES OF
MATERNAL DEATHS AND IMPROVING
HEALTH FOR WOMEN BEFORE, DURING
AND AFTER DELIVERY.
AND FISCAL YEAR '22, IMPROVE
RECEIVED $30 MILLION FROM
CONGRESS.
THE ADVISORY CABINET AND THE
TASK MORSE ARE WORKING ON
MECHANISMS TO MAXIMIZE THIS
INVESTMENT IMPACT.
KEY ACTIVITIES OF THE TASK FORCE
ARE NOTED HERE.
I WON'T REVIEW THEM TODAY IN
DETAIL BUT I ENCOURAGE YOU TO
REVIEW THESE OPPORTUNITIES AND
TO SHARE WITHIN YOUR NETWORKS.
WE WILL NOW EXPLORE CRITICAL
TOPICS WHICH IS REPRESENTATION
OF WOMEN IN THE BIOMEDICAL
WORKFORCE.
THEY HAVE THE BARRIERS THAT
WOMEN HAVE EXPERIENCING FOR
DECADES IN THE STEM FIELDS.
FOR EXAMPLE, WOMEN IN ACADEMIA
FACE MORE SEVERE VERSIONS OF
LONGSTANDING GENDER GAPS, CAREER
INTERRUPTIONS CAN HAMPER WOMEN'S
ABILITY TO TENURE, AND COVID-19
HAS HAD A DEVASTATING IMPACT ON
OUR CAREER INVESTIGATORS.
WOMEN ARE MORE LIKELY TO EXIT
THE WORKFORCE BECAUSE OF
PANDEMIC-RELATED HOUSEHOLD
RESPONSIBILITY AND WOMEN'S
DEPARTURES DO EFFECT THE
DIRECTION OF RESEARCH.
NIH IS WORKING TO REMOVE
BARRIERS FOR RECOMMEND IN
RESEARCH CAREERS BY INCREASING
FUNDING FOR RESEARCH WOMEN WITH
HIV/AIDS.
TAKING INTO CONSIDERATION
CHILDCARE COSTS FOR IN AUD
INCREASING DIVERSITY IN THE
FEMALE WORKFORCE BY THE
DIFFERENT MECHANISMS LISTED HERE
AND PROVIDING SUPPLEMENTS FOR
COVID-19 RESEARCH DISRUPTIONS.
THE WOMEN'S HEALTH RESEARCH BY
ANNUAL REPORT FOR FISCAL YEARS
2019-2020, PRESENTS INFORMATION
ABOUT SEX, RACIAL, AND ETHNIC
BREAKDOWN OF THE NIH WORKFORCE
AND GRANTEES.
OVER ALL, WOMEN'S GRANT
APPLICATION OUTCOMES HAVE
IMPROVED IN RECENT YEARS.
APPLICANTS WHO ARE FEMALES FROM
UNDER REPRESENTED RACIAL AND
ETHNIC GROUPS WERE WELL ABOVE
THOSE OF ALL FEMALE APPLICANTS
IN GENERAL AND AFRICAN AMERICAN
FEMALE INVESTIGATORS HAVE THE
LOWEST SUCCESS RATES AMONG ALL
FEMALES FROM UNDER REPRESENTED
RACIAL AND ETHNIC GROUPS.
AND A NEW PUBLICATION FROM WOMEN
LEADERS AT NIH DESCRIBES EFFORTS
TO LEAD BY EXAMPLE THROUGH
ESTABLISHMENT OF PRINCIPLES FOR
IN CONCLUSIVE EX LENS EXCELLENH
ENHANCED FLEXIBILITY OPTIONS,
CREATING CULTURES OF INCLUSION,
REQUIRES LEADERSHIP SUPPORT,
ACTION-ORIENTED ACCOUNTABILITY
AND RESEARCH INTERVENTIONS ARE
BEST PRACTICES.
THE NIH AND WOMEN RESEARCH
PORTFOLIO PRINCIPLES ARE UNDER
SCORED IN NIH UNITE INITIATIVE
AND PROACTIVE IMPLEMENTATION OF
DEIA PRINCIPLES.
WE'RE COMMITTED TO REDUCING
BARRIERS FOR RACIAL EQUITY AND
THE HIV-AIDS RESEARCH WORKFORCE
BY APPLYING A CRITICAL LENS TO
IDENTIFY OPPORTUNITIES AND
IMPLEMENT STRATEGIES TO INCREASE
INCLUSIVITY AND DIVERSITY IN THE
HIV AIDS RESEARCH ENTERPRISE.
AND TO PROVIDE PLATFORM FOR I DO
VERSE VOICES ACROSS THE HIV-AIDS
RESEARCH CONTINUUM.
IN CLOSING, I WANT TO THANK YOU
FOR THE CHANCE TO SHARE THIS
INFORMATION WITH YOU TODAY.
THE NIH IS COMMITTED TO
ADVANCING THE HEALTH AND
WELLBEING OF ALL WOMEN AND WE
WELCOME YOUR THOUGHTS AND
SUGGESTIONS.
THERE ARE MANY WAYS TO STAY
CONNECTED AND LEAVING FOR US ON
SOCIAL MEDIA.
>> THANK YOU FOR THAT REPORT.
WE HAVE A COUPLE OF MINUTES FOR
QUESTIONS.
MELISSA --
>> THANK YOU FOR THAT
PRESENTATION AND A VERY
COMPREHENSIVE AND HELPFUL.
I GUESS ONE OF THE THINGS THAT I
LEARNED ABOUT AND HEARD ABOUT
OVER THE YEARS IN THE PREVENTION
ARENA IS THAT FOR WOMEN AND
GIRLS AT RISK FOR HIV, MAY NOT
FULLY RECOGNIZE OR BE AWARE OF
THEIR RISK AND I FULLY
APPRECIATE THAT IT EVEN EXISTS.
SO THIS MAKES IT MORE DIFFICULT
TO THEN BE PROACTIVE AND PURSUE
POTENTIAL REMEDIES OR OPTIONS IN
OUR PREVENTION TOOLBOX.
ANY THOUGHTS ABOUT WORK BEING
DONE IN THAT AREA?
ABOUT RAISING AWARENESS AND
HELPING WOMEN AND GIRLS
RECOGNIZE THEIR RISK?
>> I THINK THERE'S A LOT 6
EFFORT BEING PUT INTO THIS AREA
AND ESPECIALLY WITH THE ADVENT
OF NEW INNOVATIVE LONG-ACTING
PREVENTION.
AND I'M HAPPY TO SEE THAT THE
ORGANIZATIONS DEVELOPING THESE
TECHNOLOGIES ARE COMMITTING TO
EQUITABLE ACCESS AND TO
INCORPORATING THAT INTO THEIR
PRACTICE AND I WOULD DEFER TO
CARL OR ANYONE ELSE AT NIAID TO
DISCUSS ON GOING IMPLEMENTATION
EFFORTS IN THIS AREA.
>> I WOULD JUST SAY A QUICK
WORD, WHY THIS WITH 27
INSTITUTES AND CENTERS AT NIH, A
LOT OF THE BEHAVIORAL AND SOCIAL
SCIENCE WORK IS DONE IN
PARTNERSHIP WITH NIAID BY THE
NIMH AND THAT'S WHY DIANNE ROUSH
AND HER TEAM ARE ACTUALLY
CO-HOUSED WITHIN OUR
ORGANIZATION BECAUSE IT IS IS
THIS IMPORTANT INTERSECTION
BETWEEN NOT JUST AVAILABILITY OF
THE BIOMEDICAL INTERVENTION BUT
ALSO HELPING TO MEET PEOPLE
WHERE THEY LIVE SO THEY CAN
UNDERSTAND THEIR RISK AND ALSO
UNDERSTAND THE STIGMA HA THEY
FEEL AND WHAT'S NEEDED TO HELP
THEM DEVELOP THE CULTURAL
COMPETENCY TO ACCESS THE
RELATIVELY COMPLICATED
BIOMEDICAL INTERVENTIONS.
>> GREAT.
WELL, THANK YOU Dr. MARSHAL,
AGAIN.
WHY DON'T WE MOVE.
WE HAVE A NUMBER, WE HAVE SEVEN
CONCEPTS WE ARE GOING TO GO
THROUGH AND WE WILL START WITH
THE BASIC SCIENCES PROGRAM.
Dr. SANDERS AND Dr. NOVAK
OPPORTUNITIES FOR HIV CURE
STRATEGIES AT THE TIME OF OUR
NIGMS INITIATION.
Dr. SANDERS.
>> HELLO.
I WOULD LIKE TO PRESENT TO YOU
THE CONCEPT OPPORTUNITIES FOR
HIV CURES STRATEGIES AT THE TIME
OF ART INITIATION.
THAT MY COLLEAGUELY A NOVAK AND
I DEVELOPED.
THIS FUNDING ANNOUNCED WAS
RECENTLY PUBLISHED AS A NOTICE
OF SPECIAL INTEREST AND BECAUSE
OF THE ENTHUSIASM WE RECEIVED SO
FAR, WE ARE NOT PRESENTING IT AT
THE AIDS RESEARCH ADVISORY
COMMITTEE MEETING.
NEXT SLIDE, PLEASE.
THE OBJECTIVE IS TO IDENTIFY NEW
OPPORTUNITIES FOR CURE
STRATEGIES NEAR THE TIME OF ART
INITIATION OR AS A REPLACEMENT
FOR CONVENTIONAL ART AND IT'S
THE YOU WILL HAT GOAL IS OF
ACHIEVING A SUSTAINED ART FREE
HIV REMISSION.
THE STUDIES SHOULD BE CARRIED
OUT IN ANIMAL MODELS.
CLINICAL TRIALS ARE EXCLUDED BUT
CELLS OR TISSUE SAMPLES CAN BE
USED.
THE MECHANISM IS A GRANT AND THE
ACTIVITY ROAD IS RO1 AND R21.
THE BACKGROUND IS THAT CURRENT
HIV APPROACHES ARE FOCUSED
ALMOST EXCLUSIVELY ON STRATEGIES
OF THE COMPLETE ART SUPPRESSION.
RECENT HITS IN THE STRATEGIST
HOWEVER THAT MOST OF THE
RESERVOIR BECOMES STABILIZED AND
AT THE START OF ART AND ALSO THE
TIMING OF HIV RESERVOIR IS
COMPLICATED AND UNDER
INVESTIGATION.
ALSO SOME APPROACHES IN THE
ABSENCE OF ART HAVE RESULTED IN
SUSTAINEDSUN ROW MISSION AND NH.
ARE THERE OPPORTUNITIES TO
INTERVENE BEFORE COMPLETE ART
SUPPRESSION OR AFTER ANN ANALYTL
AND IT SIMULATES THE IMMUNE
RESPONSE TIME PROVE THE OUTCOME
OF AN HIV CURE.
THIS SLIDE DID ADAPTED FROM A
FIGURE AND BOB.
CURRENT CURE STRATEGIES ARE
DESIGNED TO INTER VEN DURING
CHRONIC ART WHEN HIV IS
SUPPRESSED.
THE OUTCOMES CAN BE NO EFFECT,
CONTROL OF REBOUND OR
ERADICATION.
THE QUESTION IS WHETHER IT WILL
MAKE A DIFFERENCE TO INTERVENE
HERE AROUND THE TIME OF ART
INITIATION OR IN PLACE OF
CONVENTIONAL ART.
NEXT SLIDE, PLEASE.
THE LONGITUDINAL LEVELS OF
PLASMA AFTER ART NISHTATION WERE
PUBLISHED RECENTLY AND THERE'S A
DECAY WHICH AN AVERAGE HALF LIFE
OF 1.2 DAYS FOR PHASE 1 AND 30
DAYS FOR PHASE 2.
AND IN CONCLUSION, ON GOING
VIRUS PRODUCTION OCCURS MOSTLY
IN THE FIRST THREE MONTHS OF THE
INFECTION.
BETWEEN THREE AND SIX MONTHS,
HIV PRODUCTION DECLINES MORE
SLOWLY AFTER WHICH TIME POINT IT
BECOMES UNDETECTABLE.
INTERVENTION TO ART AND PLASMA
VIRUSES IN STEEP DECLINE MAY
ACCELERATE THE TIME TO FULL
SUPPRESSION AND MAY REDUCE THE
SIZE OF THE LATENT RESERVOIR.
THIS PAPER FROM ABRAMS FROM THE
OO2 STUDIES A SMALL COHORT OF
NINE WOMEN WHOSE HIV SUB TYPES C
THAT LIVED FOR AN AVERAGE OF 4.5
YEARS WITHOUT ART.
IT WAS DEMONSTRATED TO 71% OF
THE VIRAL RESERVOIR WAS MET TO
THE YEAR PROCEEDING ART.
ONLY 4% OF RESERVOIR VIRUS MET
TO THE FIRST YEAR OF INFECTION.
THE PAPER CONCLUDED THAT THE
LATE ANT VIRAL RESERVOIR IS
ESTABLISHED AT THE TIME OF ART
INITIATION.
AND REPRESENTS VIRUSES THAT
EMERGED IN THE YEAR BEFORE ART
WAS GIVEN.
OTHER STUDIES IN DIFFERENT
COHORTS WITH DIFFERENT HIV
SUPPOSE TYPES ARE ON GOING.
NEXT SLIDE, PLEASE.
THIS PAPER DEMONSTRATES THAT AN
IMMUNOTHERAPY DURING ACUTE SHIFT
INFECTION IS LONG-TERM
SUPPRESSION OF A REEMIA IN THE
ABSENCE OF ART.
THE ANTIBODIES 3BNC117 AND
10-1074 POTENTLY REDUCE VERREMIA
AND IN ADDITION IMMUNE COMPLEX
FORMATION MAY INCLUDE A VACCINAL
EFFECT AND ACTIVE PRODUCTION
STIMULATES THE IMMUNE RESPONSE
AND Dr. FAUCI PRESENTED THE
CLINICAL TRIAL USING THESE -- IF
IT'S SHOWN IN THIS SLIDE.
THEY WERE GIVEN SHIFT AAV FOR 36
WEEKS AND AT ONE TIME SHOT OF
AAV-ENCODED 3BNC117 AND 10-1074
WAS DELIVERED.
THE ANTIBODY WAS ALSO
ADMINISTERED BUT WAS CLEARED
FAST AFTER THE DEVELOPMENT OF
ANTIDRUG ANTIBODIES.
TWO OUR THE FOUR SHOWED AND THIS
IS THE FAMOUS MONKEY IN RED
HAVING UNDETECTABLE VIRAL LOADS.
NEXT SLIDE, PLEASE.
ENCOURAGING ALSO THE RESULTS
FROM THE STUDY PRESENTED AT
2022.
VOLUNTEERS WERE EITHER TREATED
WITH OUT A LOAN, ART PLUS
3BNC117 OR COMBINATION OF ALL
THREE AND DURING OUT INITIATION
INCREASED THE PREPORTION OF P24
POSITIVE CD4 CELLS WITH LATEN
SEE REVERSAL.
3BNC117 LED TO A FASTER SECOND
PHASE PLASMA DECAY AND
FACILITATED ELIMINATION OF
INFECTED CELLS.
OVER ALL, ONE PERSON FROM THIS
3BNC117 PLUS RMD GROUP CONTINUES
TO HAVE UNDETECTABLE VIRAL LOAD
3.7 YEARS AFTER STOPPING ART
WHICH IS HIGHLIGHTED IN RED.
SO, THIS SCOPE OF THIS
INITIATIVE PROPOSAL IS DIVIDED
INTO BASIC RESEARCH AND TARGETED
INTERVENTIONS.
FOR BASIC RESEARCH, SUPPORTING
ARE FIRST RESEARCH TO MAP HIV
RESERVOIR AND DIFFERENT TYPES
AND TISSUE AT VARIOUS TIME POINT
NEAR ART INITIATION AND THERE'S
ADJUSTED TOPICS COULD INCLUDE
COMPARING DIFFERENT HIV SUPPOSE
TYPES ACUTE VERSUS CHRONIC
INFECTION AND HUMAN VERSUS
ANIMAL MODELS AND DIFFERENT
POPULATIONS AND SECOND ANALYZING
HIV RESERVOIR DYNAMICS, DOUGH
KAY RATES AND CLONE
PROLIFERATION AND PREPORTION OF
ENACT VERSUS DEFECTIVE VIRUSES
AND DISTRIBUTION OF ACTIVE
VERSUS LATENT RESERVOIRS AND
REACTIVATION POTENTIAL OF LATE
ANT VIRUSES AT OR NEAR THE TIME
OF ART INITIATION.
AND FINALLY, COMPARING RESERVOIR
OR IMMUNO LOGIC STRATEGIES
DELIVERED AT DIFFERENT TIMES
POINTS WERE IN PLACE OF
CONVENTIONAL ART INCLUDING
VISUALIZATION STUDIES AND THE
APPLICANTS CAN USE EITHER CELLS
ANIMAL MODELS OR EXISTING EX
VIVO HUMAN CLINICAL SAMPLES AND
THE ENCOURAGED TEAM SCIENCE WITH
GROUPS COLLECTING CLINICAL
SAMPLES FROM CURE TRIALS.
NEXT SLIDE, PLEASE.
FOR TARGETED INTERCEPTIONS, WE
ARE LOOKING FOR FIRST
IDENTIFYING EXPERIMENTAL CURE
APPROACHES AND ANIMAL MODELS
PRIOR TO THE INITIATION OF ART
AND THAT CONTRIBUTE TO A
REDUCTION AND RESERVOIR SIZE AND
INCREASED DECAY RATE OF THE
RESERVOIR OR POST TREATMENT
CONTROL OF VIRAL REBOUND AND
SECOND, IDENTIFYING SHORT-TERM
STRATEGY IN PRE-CLINICAL MODELS
INSTEAD OF OR IN COMBINATION
WITH ART, THAT COULD DIFFER FROM
LIFE-LONG ART IN ENABLING
DURABLE CONTROL OF REBOUND WITH
ONE-TIME OR INTERMITTENT USE AND
EXAMPLES ARE INHIBITING LATTEN
SEE ESTABLISHMENT IN THE ART
START, PREVENTING CLONE ALEX
PANS OF RESERVOIR CELLS,
PREVENTING HIV DISSEMINATION,
AND LIMITING RESERVOIR SEEDING
IN SANCTUARY SITES.
PROGRAMS THAT ARE RELATED ARE
THE MARTIN DELANIE CO LAB TIRES
RENEWED AT THE END OF 2021 AND
THE CONSORTIA FOR INNOVATIVE AID
RESEARCH IN NON HUMAN PRIMATES
AND FOR INNOVATIVE HIV VACCINE
AND CURE RESEARCH AS WELL AS
UNDERSTANDING HIV REBOUND AND
HIV RESERVOIR DYNAMICS TO
ELIMINATION AND FOR WHICH THE
SUBMISSION AND ENDED.
THEY AND BY THE TIME OF ART AND
CONVENTIONAL ART.
NEXT SLIDE, PLEASE.
WE WOULD LIKE TO THANK Dr.
MONICA GANDHI FROM THE
UNIVERSITY OF CALIFORNIA SAN
FRANCISCO AND Dr. RICHARD FOR
THE HELP FOR COMMENTS AND
SUGGESTIONS IN THE PRE REVIEW OF
THIS CONCEPT, NEXT SLIDE,
PLEASE.
THERE ARE OVER ALL IMPRESSION
WAS THIS IS AN EXCITING AND
WONDERFUL INITIATIVE AND
INTERESTING CONCEPT, HOWEVER, WE
SHOULD MAKE IT CLEAR THAT THIS
IS NOT A FLOOR FOR CLINICAL
TRIALS BUT FOR BASIC SCIENCE
APPROACHES AND EXPERIMENTAL
SILENT ANIMAL MODELS AND OUR
RESPONSE IS WE CHANGE THE
OBJECTIVE AND REPLACED
INTERVENTION WITH EXPERIMENTS.
WE SHOULD ALSO KEEP THE R21
MECHANISM AND THE FOA AND
ENCOURAGE EARLY STAGE
INVESTIGATORS TO APPLY.
IT WAS ENCOURAGING AND WE WILL
IMPLEMENT IF THE INITIATIVE IS
APPROVED.
NEXT SLIDE, PLEASE.
THE REVIEWERS COMMENT WAS TO
ENCOURAGE TEAM SCIENCE AND
COLLABORATIONS WITH GROUPS
COLLECTING CLINICAL SAMPLES FROM
CURE TRIALS AND OUR RESPONSE IS
THAT WE WILL MAKE IN CLEAR IN
THE FOA IF THE CONCEPT IS
APPROVED.
FINALLY, WE WILL REQUEST TO MAKE
CHANGES TO THE SCOPE OF
INITIATIVES ON SLIDES 10 AND 11
TO PROVIDE CLARITY AND WHICH WE
IMPLEMENTED.
NEXT SLIDE, PLEASE.
THE LAST SLIDE IS A REPEAT OF
THE FIRST SLIDE.
SHOWING THE INITIATIVE TITLE,
THE OBJECTIVE AND THE MECHANISM.
THANK YOU FOR YOUR ATTENTION AND
THANK YOU VERY MUCH FOR YOUR
TIME.
>> THANK YOU Dr. SANDERS.
FASCINATING DATA AND PROVOCATIVE
IDEAS PROPOSED HERE.
WE DO HAVE TIME FOR A FEW
QUESTIONS IF PEOPLE HAVE
QUESTIONS.
LET ME -- PAM JUST PUT IN THE
CHAT, LET ME REMIND PEOPLE ON
THE COMMITTEE TO OPEN THE
ELECTRONIC COUNCIL BOOKS AND GO
TO THE DAIDS TAB AND THE SUB
LINE THERE TO BE ABLE TO VOTE ON
THIS AND THE OTHER CONCEPTS.
ANY QUESTIONS?
>> THANK YOU Dr. SANDERS AND
IT'S AN EXCITING OPPORTUNITY.
IF PEOPLE CAN GO AND ARE WE
AHEAD OF SCHEDULE?
>> ALL RIGHT.
WE'LL GIVE PEOPLE A MOMENT.
>> SO IF SOMEONE IS MONITORING
THE ECB, CAN YOU LET KEN KNOW
WHEN THE VOTES ARE ALL IN.
>> CAN I ASK A SILLY QUESTION,
THIS IS AUDRY, I'M HAVING A HARD
TIME FINDING EXACTLY WHERE THE
VOTING ROSTER IS HERE FOR THESE.
>> IT'S -- WE ALL HAVE THAT SAME
HARD TIME.
IF YOU OPEN THE ECB THERE'S A
TEAM ON THE TOP AND YOU NEED
THREE E-MAILS, THE ORIGINAL AND
THERE'S TWO E-MAILS WITH IT WITH
THE PASSWORDS AND THERE'S THE
DAIDS TAB ON TOP AND GO DOWN TO
OPEN SESSION.
THE THIRD HEADER AND THEN THE
RIGHT OF THAT VO ON DOCUMENT AND
THAT GETS YOU TO THE VOTES.
IT USUALLY TAKES ME SEVERAL
EFFORTS EVERY MEETING.
>> THANK YOU.
I WAS TOO FAR DOWN.
WHEN YOU RETIRE HE HAVE A JOB
FOR YOU IN I.T. HERE.
>> OH, YES.
[LAUGHTER]
>> THANK YOU.
>> OK.
SHALL WE BRING UP THE SECOND
BASIC SCIENCE.
>> THERE'S ANOTHER TECHNICAL
QUESTION.
>> IT WAS A REQUEST BECAUSE YOU
GET LOGGED ON AND HAVE TO LOG
BACK IN.
>> WHERE DO YOU VOTE ON THE RED
ONES?
>> THERE'S A VOTE ON DOCUMENTS.
THIS IS MEANT TO BE A TRICK AND
IT WORKS WELL.
IF YOU JUST OPEN AND CLOSE IT
EVERY COUPLE OF MINUTES, DURING
THE PRESENTATIONS IT STAYS OPEN.
>> THAT'S WHAT I WAS DOING.
>> YES.
>> EVERYBODY HAS VOTED SO THANK
YOU FOR TAKING CARE OF THAT.
>> WE'RE A SMART CREW HERE.
YOU ALL UNDERESTIMATE US.
OK.
THANK YOU.
SO, OUR NEXT CONCEPT IS ALSO
VERY INTERESTING.
THIS IS ENTITLED PRELIMINARY
OUTCOMES AND SEE QUELL EYE AFTER
TREATMENT OF TB OR POST TB IT
WILL BE PRESENT BID Dr. ROBIN
HUBNER OF THE EPIDEMIOLOGY
BRANCH IN THE BASIC SCIENCES
PROGRAM SOMEONE I HAVE WORKED
WITH FOR 15 PLUS YEARS AND THANK
YOU, ROBIN.
>> I JUST COMMENT IS THERE MUST
BE A JOKE IN THERE ABOUT HOW
MANY MDs AND PH.DES IT TAKES
TO VOTE TODAY, RIGHT.
ANYWAY, THE NEXT SLIDE PLEASE.
THIS IS PULMONARY OUTCOMES AND
SEQUELAE AFTER TREATMENT OF TB
AND OBSERVATIONAL RESEARCH AND
MORBIDITY IN TB DISEASE AND HIV
INFECTED INDIVIDUALS AND THIS IS
A NEW FOA FIVE-YEARS AND OUR
PARTNERS ARE NIAID AND NIEHS
WHICH IS ENVIRONMENTAL HEALTH
AND CHILDREN TO FOSSIL FUEL AND
OUTDOOR COOKING, ET CETERA.
FOR THOSE THAT DON'T KNOW ALL
I'M SURE MOST YOU DO, 23% OF THE
WORLD'S POPULATION IS EFFECTED
BY TUBERCULOSIS AND THERE ARE
MORE THAN 9 MILLION NEW CASES
ANNUALLY OF WHICH 1.1 MILLION
ARE UNDER THE AGE OF 15.
CURE IS A DISAPPEARANCE OF MTB
AND THE RESOLUTION OF CLINICAL
SYMPTOMS AND RESOLVED EXIST
X-RAY AFTER SIX TO NINE MONTHS
OF TREATMENT ALTHOUGH TREATMENTS
ARE SHOTTENNING.
DESPITE CURE, UP TO 50% OF
PATIENTS HAVE PERSISTENT
PULMONARY DYSFUNCTION AT THE
TIME OF TREATMENT COMPLETION.
WHAT WE'RE TALKING ABOUT IS THAT
AS THE PERSON IS LEAVING THE
CLINIC AND YOU ARE
CONGRATULATING THEM ON FINISHING
THEIR SIX TO NINE MONTHS OF
TREATMENT, THEY'RE WORKING OUT
THE DOOR WITH LUNGS THAT MAY NOT
BE FUNCTIONING PROPERLY.
AND THIS MAY BE PERMANENT
PULMONARY DAMAGE.
FOR ADULTS, IT INVOLVES
INFLAMMATION, EXCESSIVE BRON
MUCHIECTASIS AND THERE'S ADULT
WHO'S HAVE HAD TB OF PULMONARY
ASPERGILLOCIS AND MAY CONTRIBUTE
SUBSTANTIALLY TO THE COPD BURDEN
AND PEOPLE WITH T.B. ARE LIKELY
TO DIE WITHIN THE FIRST FIVE
YEARS THAN THE GENERAL
POPULATION AND THEY DIE OF
THINGS THAT ARE NOT RELATED TO
TUBERCULOSIS.
FOR CHILDREN, MUCH OF THE
DISEASE IS SUBCLINICAL THROUGH
CHILDHOOD OR THE DAMAGE AND THEY
CAN DEVELOP SYMPTOMS AND
RESPIRATORY MORBIDITY AS THEY
ENTER ADULTHOOD.
ONE PEDIATRICIAN TOLD ME THE
KIDS CAN LOOK FINE AND YOU
STRESS THEM AND YOU REALIZE
THEIR LUNGS AREN'T FUNCTIONING.
THE BOTTOM SLIDE THAT'S IN RED
SAYS POTENTIALLY 1.75 MILLION
PERSONS WITH HIV MAY HAVE
PERSISTENT LUNG DAMAGE FROM T.B.
SO THIS IS NOT A MINOR PROBLEM.
SO THE SCIENTIFIC QUESTIONS THAT
WE'RE INTERESTED IN TB DISEASE
AND THE AFTERMATH ARE THE
LEADING CAUSE OF DEATH PEOPLE
LIVING WITH HIV AND AS I SAID,
IF YOU'VE HAD EVEN IF ARE
CONSIDERED CURED.
LUNG FUNCTION IN ADULT AND
CHILDREN WITH HIV AND WE DON'T
KNOW MUCH.
WE DON'T KNOW THE PREVALENCE AND
CLINICAL FAN FESSTATION OR
DIFFERENCES BY HIV STATUS IN
TREATMENT.
A LOT OF THE DAMAGE THAT'S DONE
IS DUE TO THE INDIVIDUAL IMMUNE
RESPONSE SO IF YOU ARE HIV
EFFECTED AND YOU DON'T HAVE A
ROBUST IMMUNE RESPONSE, ARE YOU
BETTER OFF?
DO YOU END UP WITH LESS DAMAGE
AT THE END OF TREATMENT THAN
SOMEONE WHO ISN'T HIV INFECTED.
WE DON'T KNOW THOSE ANSWERS ARE
THERE BIOMARKERS, ARE THERE WAYS
THAT WE CAN POTENTIALLY IDENTIFY
INDIVIDUALS THAT GET DAMAGE BY
BIOMARKERS AND THEN PERHAPS
AMELIORATE THAT DAMAGE DURING
THIS TREATMENT.
ARE THERE RISK FACTORS FOR LUNG
DYSFUNCTION AND SEVERITY OF
DAMAGE?
THESE ARE NUTRITIONAL STATUS,
BEHAVIORAL FACTORS SUCH AS
ALCOHOL, TOBACCO USE, AND
ENVIRONMENT ALEX POSE YOU'RES
AND ARE THERE IMMUNE FACTORS OR
MECHANISMS WHICH COULD ENHANCE
PATHOGENESIS AND POTENTIALLY BE
TARGETS FOR INTERVENTION AND IN
ADDITION, WE'RE INTERESTED IN
THE RISK OF RECURRENT TB AND
OTHER LUNG INFECTIONS,
CARDIOVASCULAR DISEASE OR COPD.
I THINK THERE'S A GROWING BELIEF
THAT PRIOR TB MAY CONTRIBUTE TO
THE GLOBAL COPD BURDEN AND AS
ONE PULL MINUTOLOGIST SAID, THEY
RECEIVE COPD IN THEIR 40s NOT
LATER IN PEOPLE WHO WERE NOT TB
PATIENTS.
AND ARE THERE STRUCTURAL
BARRIERS, YOU KNOW, THERE'S
ECONOMIC IMPACTS OF TB TREATMENT
AND LONG-TERM MORBIDITY AND MANY
NEXT SLIDE.
THE BOTTOM LINE, LITTLE IS KNOWN
ABOUT THE LONG-TERM SEQUAELE OF
TB MOST TREATMENT AND LESS ABOUT
HOW HIV IMPACTS HA AND WE'RE
INTERESTED IN HIV AND HIV
TREATMENT BIOMARKERS AND ALSO
THIS IS AIMED AT BETTER
UNDERSTANDING THE IMPACT OF HIV
ARC AND IMMUNE RESPONSE AND
STRATEGIES TO REDUCE THE BURDEN
OF LONG-TERM SEE QUELLY
FOLLOWING THE TREATMENT OF TB.
SO, RESPONSIVE APPLICATIONS WILL
ENROLL PARTICIPANTS.
WE ARE NOT INTERESTED IN
ENROLLING DINOVO CO HEARTS AND
FOLLOWING THEM FOR 20 YEARS.
WE KNOW THAT EXISTING COHORTS
ARE GROUPS OF TB PATIENTS AND
SUCH AS AN IDEA IN TB REPORTS
THE CFARCE COMPLETED CLINICAL
TRIALS IN THE ACTG AND
PUBLIC-HEALTH DEPARTMENTS SO WE
WOULD LIKE TO ENROLL THOSE
PARTICIPANTS AND THEN ADD ON
ADDITIONAL EVALUATIONS DURING
THE TREATMENTS AND AT TREATMENT
END.
MANY TB PATIENTS AROUND THE
WORLD NEVER HAVE A PULMONARY
FUNCTION TEST DONE SO WE'RE
TALKING ABOUT ADDING THOSE TESTS
AND EVALUATIONS TO PEOPLE BEING
TREATED AS PART OF ANOTHER STUDY
OR A PUBLIC-HEALTH DEPARTMENT OR
HAVE BEEN TREATED BECAUSE THEY
WERE PART OF A CLINICAL TRIAL.
WE ARE NOT INTERESTED IN
EVALUATING INDIVIDUAL TB DRUGS
OR DRUG REGISTER MINUTES AND
WE'RE NOT INTERESTED IN MDR AND
ONLY XDIP PATIENTS WE KNOW THEIR
TREATMENT IS MORE COMPLEX AND
MUCH LONGER AND WILL HAVE MORE
DAMAGE.
WHILE WE DON'T MIND A FEW DRUG
RESISTANT CASES, WE'RE NOT
LOOKING FOR ENTIRE COHORTS OF
MDR AND XDR.
I THINK WE WOULD LIKE TO THANK
Dr. GUPTA AND Dr. ABRAMS.
WE WERE INCORPORATED THEIR
COMMENTS INTO WHAT I JUST
PRESENTED.
THEY FELT THAT IT WAS A VERY
IMPORTANT INITIATIVE.
THEY WANTED US TO BE MORE
FLEXIBLE IN OUR INTERPRETATION
OF COHORTS SO WE HAVE INCLUDED
INDIVIDUALS WHO HAVE COMPLETED
ACTG OR IMPACT CLINICAL TRIALS
AND WHO FOLLOW-UP COULD BE
EXTENDED TO LOOK AT
POST-TREATMENT PATHOLOGY AND
ALSO, WHOSE ALREADY HAVE
SELECTED BIOSPECIMENS THAT COULD
BE EXAMINED FOR BIOMARKERS.
AND WE'RE INCLUDING EXAMINATION
OF RISK FACTORS AND WE'RE ALLOW
FOR PROSPECTIVE ENROLLMENT TO
INCREASE THE STATISTICAL POWER
BUT WE'RE HOPING THAT WE DO NOT
HAVE TO ENROLL PATIENTS
COMPLETE, YOU KNOW, START FROM
SCRATCH AND THAT WE COULD ALLOW
PERSPECTIVE ENROLLMENT TO
INCREASE POWER FOR CERTAIN
SCIENTIFIC QUESTIONS.
I THINK THAT'S THE END.
WE THANK THE REVIEWERS FOR THEIR
COMMENTS.
I FELT LIKE I WAS PREACHING TO
THE CHOIR.
I WAS TALKING TO THEM.
>> THANK YOU, Dr. HUBNER.
WE HAVE A FEW MOMENTS FOR
QUESTIONS.
I GUESS NO ONE HAS QUESTIONS.
>> I HAVE ONE QUESTION.
ROBIN.
FIRST OF ALL, YOU ALREADY HEARD
MY ENTHUSIASM AND IT'S SUCH AN
IMPORTANT TOPIC AND HOPEFULLY WE
WILL GET A LOT MORE NEW IN
SIGHT.
DO YOU HAVE ANY SENSE OF HOW
MUCH OF THIS WILL BE -- IS THE
PEDIATRIC COMPONENT DEPENDENT ON
GETTING NICHD FUNDING IN
PARTNERSHIP OR DO YOU THINK --
>> I DON'T BELIEVE SO
NECESSARILY.
BECAUSE WE DO -- I HAVE BEEN
WORKING ON THIS WITH OUR OWN
PEDIATRIC GROUP.
>> GREAT.
>> THEY'RE VERY INTERESTED AS
WELL AS WITH THE TB TEAM.
SO, I DON'T THINK THAT -- I
THINK IF WE GET A GOOD PEDIATRIC
APPLICATION IN IT WOULDN'T
NECESSARILY RELY ON NICHD IF IT
WAS VERY HIV FOCUSED.
>> GREAT, THANK YOU.
LET ME REMIND EVERYONE ON THE
COMMITTEE TO OPEN YOUR ECB
FOLDERS AND VOTE.
AND OR REOPEN THEM IF THEY'RE
CLOSED.
SO PEOPLE CAN DO THAT AND IT
WOULD BE GREAT.
AND ONCE WE ARE SET WITH THAT,
WE HAVE 10 MINUTES TO TAKE A
BREAK.
SO, MAYBE YOU CAN LET ME KNOW
WHEN THE VOTING IS COMPLETE,
THAT WOULD BE GREAT.
ALL THE THE VOTES ARE IN.
>> SUPER.
THANK YOU.
>> OK, LET'S TAKE A 10-MINUTE
BREAK SO I GUESS UNTIL 2:17.
THANK YOU EVERYONE, WE'LL BEING
BACK SHORTLY.
>>IF YOU CAN REOPEN YOUR
ELECTRONIC COUNCIL BOOKS OR OPEN
IF THEY'RE STILL OPEN.
WE CAN BRING UP THE NEXT
PRESENTATION.
GREAT.
SO THIS IS FROM THE VACCINE
RESEARCH PROGRAM AND LET ME SHUT
THAT OFF.
ENTITLED SIN THEY H SNAP H AND M
LENTED BY ANGELA MALASPINA.
>> GOOD MORNING.
GOOD AFTERNOON, EVERYBODY.
I THINK I GOT STAY WITH MY TIME
METHOD.
FROM THE PROGRAM AND WE PRESENT
IN A NEW CONCEPT SIN NET SNAP-H
WITH THE THERAPEUTIC RESEARCH
PROGRAM IN THE BASIC SCIENCES
PROGRAM WHICH STEPHEN SMILEY AND
BRIGITTE SANDERS AND OTHERS.
SO THE OBJECTIVE OF THIS CONCEPT
IS ADVANCE NUCLEIC PLATFORM FOR
THE RAPID DEVELOPMENT AND
TESTING OF PRO FOE LAUGH TICK
AND VACCINES AND THE ANTIBODIES
AND ANTIBODIES PREVENTION AND
TREATMENT AND CURE SO THE
ADVANTAGES OF THE PLATFORM IS
FOR EXAMPLE, IN TERMS OF SPEED
OF MANUFACTURE AND TESTING AND
SO THE GOAL OF THIS CONCEPT IS
THE EXPERIENCES AND LESSON
LEARNED FROM THIS TECHNOLOGY AND
THEM INTO NIH FOR WE CHOSE THE
R61/R33 BUY FACE IKA WARD OF
FIVE YEARS AND THE APPLICANTS
MAY REQUEST THREE YEARS OF
SUPPORT FOR R61 PHASE AND TWO
YEARS FOR R33 PHASE AND WE HAVE
FIRST YEAR TO THE CAUSE OF
3 MILLION.
SO THE KEY FEATURE OF THE
PROGRAM THIS IS AS I SAID IT'S
R61 AND R33 AND WE NEGOTIATED
THE TERMS OF THE AWARD AND TWO
PHASES SO THERE'S AN INITIAL R61
PHASE AND WE FOUND ACTIVITIES
THAT WE PROVIDE NOVEL INSIGHTS
REGARDING THE IMMUNO AGAINST OR
RISE IN ANTIBODIES DERIVATIVES
AND IF THIS PHASE MOVES IT TO
R33 PHASE AND THE R33 PHASE PRE
CLINICAL PRODUCT DEVELOPMENT
ACTIVITIES TO FACILITATE THE
TRANSLATION OF THE R61 PHASE
RESEARCH TO CLINICAL VALUATION
AND THIS PHASE MAY INCLUDE
EVALUATION IN MODELS OR
ASSESSMENT OF THE FEASIBILITY
RIGHT NOW ALSO WE'RE GOING TO
ENCOURAGE THE TRANSLATION
BETWEEN ACADEMIA INDUSTRY AND
GOVERNMENT BECAUSE WE BELIEVE
THAT THEY WILL LESS STRENGTHEN
THE LIKELIHOOD OF SUCCESSFUL
CLINICAL TRANSLATION.
THE PANDEMIC ESTABLISHED THIS
APPROACHES AND PEOPLE
DEVELOPMENT IN TESTING IT SO WE
SHOW HERE AS AN EXAMPLE THE
ACCELERATED TIMELINE FOR THE
MODERNA mRNA 1/73 AND REALLY
63 DAYS FROM THE FINALIZE
SEQUENCE TO THE FORCED
PARTICIPANT ENROLLING PHASE AT
CLINICAL TRIAL.
SO DAY THREE WAS TO LEVERAGE AND
EXPAND SUCCESSES IN NUCLEO ACID
PLAS FORM TO THE PACE AND THE
TEST STRATEGIES FOR PREVENTION
TREATMENT AND CURE.
SO THE OBJECTIVES ARE REALLY TO
AVOID WAY APPROACHES CAN BE USED
FOR DIFFERENT TYPES OF HIV
IMMUNO AGAINST AND COMPLEX
REGIMENTS AND THE AN TA VICE TO
STATUS AND WE UNDERSTAND THAT IT
WILL BE UNIQUE REQUIREMENTS OF
OUR VACCINE AND NEEDS TO BLOCK
INFECTIONS VERSUS ONE THAT COULD
BE USED TO TREAT HIV INSPECTED
INDIVIDUAL.
THE PLATFORM AND ILLICIT
STRONGER IMMUNO RESPONSES AND
CAN SUPPORT THE DELIVERY OF
MULTIPLE BNABS OR BNAB DERIVE
DIFFERENCE FOR THE PREVENTION,
TREATMENT AND CURE SO WE WANTED
TO EXPLORE WHEN THIS PLATFORM
CAN DO FOR HIV FIELD AND AT THE
SAME TIME, WE ALSO KNOWLEDGE HIV
UNIQUE CHALLENGES.
SO THESE INCLUDE OF COURSE, THE
ASTRONOMICAL LIST EQUAL
WEDNESDAY DIVERSITY AND WE KNOW
SNIFF AND AIDS SURVEILLANCE SO
HIV RECOGNIZE SYSTEM WHICH
RELEASE MEANS THAT THE
ANTIBODIES ARE UNINFECTION OR
THROUGH EXPLANATION.
AND SO BNABs INDEX AND WILL
LIKELY REQUIRE COMPLEX
IMMUNIZATION REGIMENTS AND THE
MAY INCLUDE ACTIVATION AND RATE
ANTIBODY PRODUCTION.
ALSO IMMUNE RESPONSES AFTER
INFECTION ARE NOT EFFECTIVE ON
COVID-19 INFECTION PROVIDING
AGAINST REINFECTION SO
PREVENTION OR CONTROL OF HIV MAY
REQUIRE SUSTAINED PROTECTIVE
RESPONSES TO MULTIPLE AND BOTH
THE BROAD AND NEUTRALIZING AND
WE NEED PROBABLY ALL THE IMMUNE
SYSTEM.
IT'S A WELL-ESTABLISHED
INFECTION AND OVER ALL WITH HIV
WE HAVE A ANTIGEN PROBLEM AND
HIV ANTIGEN FOR VACCINES NEEDS
TO BE SELECTED SO IN THAT
REGARD, WE CAUTION THAT IT CAN
SOLVE THE MENTAL CHALLENGES.
HOWEVER, THERE ARE
OPPORTUNITIES, AND YEAH, ON THE
RIGHT ARE DIFFERENT VACCINE PLAS
FORMS AND THEY'RE EMPLOYED
COVID-19 VACCINE WHICH IS ON THE
ONE WITH THE CIRCLE SO AS I
SAID, AND REALLY LIKE THE
PROPERTIES IN ALSO THE
OPPORTUNITIES AND IT WOULD BE
PROVEN TO BE SAFE AND RAPID,
SCALABLE AND LOW COST OF
MANUFACTURING.
ALSO ALLOW FOR RAPID UTTER A
TIVE TESTING ON TA HIGHIZATION
OF CONCEPT AND VERSATILE AND SO
THEY CAN ACCOMMODATE DIVERSITY
AND PUBLICITY OF INSERTS FOR
BROAD COVERAGE AND IT CAN BE
SPREAD TO SECRETE AND PROTEINS
SO WE CAN ALSO DO PRACTICE
CALECHES TO ADDRESS WHAT IS VERY
IMPORTANT FOR US, A FIN ACTIVITY
AND DIVERSITY AND IT STILL NEEDS
AND IT'S PART OF THE GAP THAT I
THINK THIS INITIATIVE WANTS TO
COVER.
ALSO SELF-ADJUVANTED AND IMMUNO
GENETIC AND ALSO NO SUPPORT OF
CENTERS FOR THE DEVELOPMENT OF
THE MEMORY IN PLASMA CELLS.
EVEN IF WE ARE ALWAYS ON THE
LOOK OUT FOR INCREASE THE
INTARGET CELLS FOR HIV, NEXT.
SO, ON TOP OF CONTINUED
OPPORTUNITIES FOR THIS PLATFORM,
ON TOP YOU SEE THE PLASMA DNA
ANMODIFIED AND FOR EMERGENCY USE
FOR VACCINE AND WE LIKE SOME
DISTINCTIVE REPORTS OF THE
DIFFERENT FORMS THAT WE THINK
REALLY CAN BE FOR DESIRE ABLE
RESPONSE AND YOU KNOW, YOU CAN
SEE FROM THE PROPERTIES OF THIS
DIFFERENT PLATFORM, FOR EXAMPLE,
THE MIX T-CELL AN TOE BODY WITH
THE DNA OR STRONG ANTIBODIES FOR
MODIFIED mRNA, STRONGER T
CELLS FOR MODIFY AND ALSO IN
TERMS OF STABILITY, WE MAY HAVE
A HIGH STABILITY FOR DNA OR FOR
EXAMPLE THE CIRCULAR AREA AT THE
BOTTOM AND DIFFERENT IN TERMS OF
SUPPRESSION OF ANTIGEN FOR
EXAMPLE MOST SUSTAIN EXPRESSION
WITH THE TRANS-AM NOT FIE SO
THERE'S A LOT OF PROPERTIES OF
THIS FORM CAN BE HARNESSED FOR
HIV.
WE ARE GOING FOR VERY GOOD
IMPORTANT OPPORTUNITY IN THIS
INITIATIVE WOULD COME OUT AND
THESE ARE REALLY COME FROM
LEVERAGE OF THE LESSONS FROM RNA
AND DNA VACCINES AND DIFFERENT
STAGES AND DEVELOPMENT AND FOR
SARS-CoV-2, HIV, NON-HIV
INFECTIOUS DISEASES, CANCER AND
THE DELIVERY OF MABS.
TO GIVE YOU AN EXAMPLE IS THE
DATA FROM THE LANDSCAPE FROM
SEPTEMBER AND DELIVERING 98 IN
DEVELOPMENT 24RNA AND 117
CLINICAL VEMMENTS FOR 41RNA AND
16DNA SO FOR 24% IN TERMS OF THE
RNA AND 9% FOR DNA.
MOST OF THE OPPORTUNITIES WILL
BE BECAUSE OF A LOT OF VACCINE
AND REALLY CATCHING THE
MOMENTUM.
I THINK IT WILL BE IMPORTANT TO
SPAN THE POOL OF PLATFORM
DEVELOPER WORKING WITH HIV
EXPERTS AND ENCOURAGING A
COLLABORATION WITH JUSTTATIONAL
FACTORS FOR THIS INITIATIVE.
I WANT TO YOU THINK ABOUT THE
RELATIONSHIP TO OTHER AWARDS AND
PROGRAMS THAT SUPPORT HIV A WORK
IN NUCLEO APPROACHES AND MINELY
FOR HIV PREVENTION AND WE KNOW
THAT OUR HIV INVESTIGATOR ARE
INNOVATORS AND VERY RESOURCEFUL
IN SOME WORKING WITH THE
PLATFORM BEFORE THE PANDEMIC AND
WHAT IS REALLY HAPPENING NOW AND
I PUT EXAMPLES OF THE PROGRAM
THAT WE SUPPOSE SORTED IT TO
PROBABLY RECOGNIZE ON THE LEFT
AND LIKE THE CON SORE SHA FOR
HIV/AIDS VACCINE DEVELOPMENT AND
THE HIVRAD, HIV VACCINE AND RO1
AND IT'S NOT COMPLETE
COMPREHENSIVE THEY'RE DOING WORK
BUT WHAT IS HAPPENING RIGHT NOW
IS REALLY ABOUT COMPARING THE
SAME CON INFRASTRUCTURE
DELIVERED BY RNADNA TO
TRADITIONAL AND NEXT, HOWEVER,
WE DO THINK THAT OUR PORTFOLIO
STILL NEEDED TO INCLUDE LIMITED
NUMBER OF DEVELOPERS SO IF YOU
GO IN THE TABLE AND LOOK AT
ORGANIZATIONS BIOTECH INVOLVE
AND AND THE AND BION PECK AND WE
HAVE 61 TO SAY BUT THESE ARE THE
ONLY DEVELOPERS WE'VE BEEN
WORKING WITH.
ALSO, THE AND THIS TECHNOLOGY
WILL BE WITH US FOR A WHILE AND
WE LIKELY EVOLVE AND IMPROVE SO
NEXT.
SO, YEAH, I LIKE THE NIAID DATES
AND ANTIBODY PIPELINE SO 21 AND
23 AND WHAT IS HAPPENING NOW IN
THE CLINICAL GOAL IS REALLY TO
ESTABLISH THE FEASIBILITY ON THE
NUCLEAR ACID PLATFORM AND USING
VACCINES THROUGH HUMAN TESTING
IN EXPERIMENTAL TRIALS SO HERE
IF YOU GO TO THE TABLE THERE ARE
SOME PROTOCOLS FOR EXAMPLE THE
TESTING NOW MULL POLL
NATIVE-LIKE TIMERS WHERE WE
REALLY ARE LOOKING AT IMMUNO
AGAINST WHEN THEY DELIVER THE
CASE OF SOL YOU ABLE AND WE ALSO
HAVE A MULTIPLE IMMU IMMU -- IMO
AGAINST --
AND HOPEFULLY WE START THE CYCLE
TO GO BACK FOR CLINICAL BECAUSE
THIS PROBABLY IS A STILL PRODUCT
AND THIS IS STILL AT THE LEVEL
EXPERIMENTAL TRIAL OR IF THEY'RE
PROMISING, GO TO THE PRODUCT.
AND ALSO I THINK IT'S VERY
IMPORTANT, LESSON LEARNED IS THE
PREDICTIVE VALUE OF ANIMAL MODEL
IS THE SAME REGIMENT TESTED IN
HUMAN ANIMAL MODELS AND WHEN
THESE MODELS WILL BE VE VALIDATD
IT WILL BE EASIER AND FASTER TO
GO TO THE CLINIC.
SO HERE ARE EXAMPLES OF SCOPE
RESEARCH SO TO LOOK AT RESPONSES
AND WE LIKE STRATEGIES FOR
STABLATION OF IMMUNOGENIC AND
INCLUDED BY RNA/DNA NEED TO BE
GOOD SPIKES AND VARIANTS AND
EPITOPES AND WE LIKE TO SEE
DEVELOP OF ANTIGEN AND VACCINE
AND THIS IS A PLATFORM THAT
REALLY DO WELL IN UNIVERSITY.
INVESTIGATE CO-DELIVERY OF
RNA/DNA IMMUNOGENS AND IN
ADJUVANT AND MABS AND RND/DNA
FOR DELIVERY OF COMBINATION WITH
OTHER PLAS FORMS AND I WOULD
LIKE TO OPTIMIZE REGIMENTS
INCLUDING ROUTES OF
ADMINISTRATION, DOSES, AND
IMMUNIZATION INTERVALS TO
INCREASE DURABILITY AND EXPLORE
SUSTAINED DELIVERY TO SPECIFIC
CELL TYPES AND TISSUES AND
OPTIMIZE DELIVERY OF MULTIPLE
BNABS AND BNAB DERIVATIVE.
TO USE A SIN T -- AND FOLLOWED Y
INFUSION AND NON ACTIVITY RESORT
PURE PLOT FORM IMPROVEMENTS.
SO, YEAH, WE ARE REALLY THANKFUL
FOR REVIEWER COMMENTS AND
STEPHEN WALLACE AND RECOMMEND
CONCEPTS FOR APPROVAL BUT
REVIEWER SO THESE CONCEPT IS
TIMELY AND NEEDED AND THEY
RECOMMEND MORE ON THE NEED FOR
INCREASED EFFORTS ON SYNTHETIC
NUKELY I CAN ACID PLATFORMS AND
WE BELIEVE REGIMENTS THAT PROMIE
AND EFFECTING EFFECTIVENESS AND
DURABILITY AND FILL GAPS IN
IMMUNE LOGICAL STRUCTURE AND
FORMULATION PROPERTIES OF THESE
EVOLVING PLATFORMS FOR IMPROVED
PERFORMANCE IN THE CONTEXT OF
HIV AND THE UNIQUE CHALLENGES.
ALSO, WE THANK FOR THE QUESTION
ABOUT ADDRESSING EQUITY
DIVERSITY OF FILING FOR THIS
INITIATIVE AND ACCESS TO THE
PLATFORM AND VACCINE DEVELOPMENT
AND THIS INITIATIVE.
RERESPECT EQUITY AND DIVERSITY
TO LEVEL OF SCIENCE AND ACCESS
AND CDA AND PRODUCTS GLOBALLY
AND.
THERE ARE A LOT OF ACTIVITIES SO
WE WANT YOU TO SPEND A LITTLE
BIT FEW MORE TO GO A LITTLE BIT
MAYBE REPEATING ALSO WHAT WE'VE
BEEN SAYING THIS MORNING SO NEXT
SLIDE.
SO MAP EQUITY AND DIVERSITY IS
WE SAID IS PREPARING STRATEGIC
PLAN FOR DIVERSITY AND THE DEIAO
ADDRESS THIS CONCEPT TO
WORKFORCE STRUCTURE, CULTURE AND
THERE'S SUPPORT AND DID FAUCI
SAID IN 2021 NIAID ESTABLISHED A
DIVERSITY COUNCIL TO FIND WAYS
FOR NIAID FUNDED RESEARCH TO THE
WAYEST IMPACT POSSIBLE
ESPECIALLY FOR THOSE MOST
AFFECTED BY DISEASE.
SO THEY WILL TAKE ACCESS OF THE
VACCINE IS BEEN IN THE PUBLIC
EYE ESPECIALLY ABOUT THE
DISADVANTAGE A PLATFORM DURING
THE SARS-CoV-2 PANDEMIC SO WE
HAVE TO SAY THESE ARE GRANTS AND
IT'S LIMITED BY THE ACT AND IT
ENABLES UNIVERSITY NON-PROFIT
AND MORE BUSINESSES TO OWN,
PATENT AND COMMERCIALIZE
INVENTIONS DEVELOPMENT UNDER
FEDERALLY FUNDED RESEARCH.
HOWEVER, WE ARE PROUD TO SAY
THAT OUR HIV SCIENTISTS HAVE
BEEN SENSITIVE TO THE NEEDS OF
PEOPLE IN THE DEVELOPING WORLD
AND ARE ENCOURAGED TO WORK WITH
LOW/MIDDLE INCOME COUNTRY
SCIENTISTS TO SHARE TECHNOLOGIES
BUT OF COURSE INVESTIGATORS
CANNOT DO IS THE INTELLECTUAL
PROPERTIES FROM BIO TECHS AS AN
EXAMPLE GIVEN TODAY FROM THE
GIVE BACK IS THE WORK THAT WE
DID SAY UNDER THE APCB PROGRAM
ARE WORKING TO TRANSFER THE HOW
TO SOUTH AFRICA TEAMS IN THE
W.H.O. AND HAVE THE RARE
INVESTIGATOR IN THI THAILAND.
THIS IS THE END OF MY
PRESENTATION.
PLEASE, ANY QUESTIONS, THANK
YOU.
>> THANK YOU, VERY MUCH.
VERY NICE PRESENTATION.
VERY EXCITING PROGRESS IN THIS
AREA.
QUESTIONS.
>> I HAVE A CLARIFYING QUESTION.
YOU ARE GOING TO DO ACTIVE AND
PASSIVE IMMUNIZATION IN THIS
MECHANISM.
>> YOU ARE CORRECT, YES.
>> AND I GUESS THAT'S FINE.
I MEAN, THEY'RE BOTH IMPORTANT.
>> WE HAD THIS WORKSHOP IN MAY
ABOUT THE DEVELOPMENT OF
ANTIBODY AND WE HAD A SESSION ON
PLATFORM DEVELOPMENT AND
DELIVERY AND REALLY IT WAS A
GAP.
THE DELIVERY OF ANTIBODIES SO WE
SAW IT AS AN OPPORTUNITY AND
HERE TO (INAUDIBLE) BECAUSE IT'S
REALLY MORE GLOBAL ACCESS OF
THIS --
>> I WONDER, I MEAN, I GUESS
IT'S TOO LATE TO CHANGE THE
TITLE BUT, TO INCLUDE THAT
ASPECT.
BUT ANYWAY.
BECAUSE THERE MAY BE A LOT OF
PEOPLE WHO WON'T EVEN KNOW ABOUT
IT.
>> YEAH.
OK.
YEAH.
WE'VE BEEN VAGUE IN OUR TITLE.
YEAH.
AS A PLATFORM BUT YEAH WE WILL
RECONSIDER THAT, THANK YOU.
>> OK.
LET ME ASK PEOPLE TO VOTE.
WE HAVE A COUPLE OF MINUTES IF
WE HAVE ANOTHER QUESTION.
>> THANK YOU Dr. MALASPINA.
WE WILL CONTINUE.
WE'RE A LITTLE BIT AHEAD OF
SCHEDULE WHICH IS ALWAYS NICE.
MAYBE WE CAN BRING UP THE NEXT
CONCEPT.
SO, THIS IS ENTITLED RATIONAL
SYSTEMATIC CHARACTERIZATION AND
SELECTION OF ADD YOU VENT WILL
BE RECOLLECTED BY Dr. MILTON
MACIEL.
>> I HOPE YOU CAN HEAR ME.
IS THAT OK?
>> YES, GREAT.
>> GREAT.
THANK YOU, SO GOOD AFTERNOON FOR
THOSE IN THE WEST COAST AND GOOD
MORNING FOR THOSE IN THE WEST
COAST.
MY NAME IS MILTON MACIEL FROM
THE DIVISION OF AIDS AND I'M
GOING TO INTRODUCE THE RATIONAL
SYSTEMATIC CHARACTERIZATION
SELECTION OF ADJUVANTS FOR HIV
VACCINE CANDIDATES.
TO OPTIMIZE HIV ADJUVANTS FOR
DURABILITY AND AND MAGNITUDE OF
HIV VACCINES -- AND BASED ON THE
DESIRE IN LARGE PROFOUND AND
THIS IS A NEW MECHANISM AND IF
IT'S A BROAD AGENCY ANNOUNCEMENT
WITH THE DURATION OF FIVE YEARS
AND WE HOPE THAT WE EXPECT TO
AWARD ONE CONTRACT.
SO I'LL START BY BRIEFLY
REVIEWING NIAID APPROACH TO
SUPPORT INVESTIGATE AND ADJUVANT
FOR VACCINE.
IN 2018, THIS STRATEGIC PLAN
DEFINED THREE MAJOR AREAS THAT
NEEDED TO BE ADDRESSED.
FIRST, FUNDAMENTAL IMMUNOLOGY
AND ADJUVANT AND DEVELOPMENT IN
CLIN TAL A VESMENT AND THIRD
CLINICAL EVALUATION OF
ADJUVANTED VACCINES.
SUPPORT SIDE BY SIDE COMPARISON
IN COMBINATION WITH CLINICAL
RELEVANT VACCINES AND AG
PLATFORMS.
ESTABLISH BOTH SIS FEMALE I CAN
AND TISSUE-SPECIFIC IMMUNE
LOGICAL PROFILES AND EMPLOY AND
THE CALLS IN ENDJOINED ASSAYS
FOR EXPERIMENT AND CONTINUES
SCREEN POTENTIAL NEW ADJUVANTS,
NEXT SLIDE.
PLEASE.
THIS TIMELINE SUMMARIZED TWO
DECADES OF INITIATIVES
PHOTOGRAPHICKED ON THE
DEVELOPMENT OF ADJUVANT BUT IT'S
NOT EXHAUSTINGED LIST.
AS YOU CAN SEE BELOW THE
TIMELINE, THE DIVISION OF
ALLERGY AND KNOWLEDGE OF DATE
HAS MAINTAINED OVER THE YEARS.
A LARGE PORTFOLIO FOR THE
PROGRAMS FOCUS ON ADJUVANT AND
IN 2021, THE COMPARE ON BA8 FOR
ALLERGY, CANCER, AND SEVERAL
DISEASES FORMALLY EXCLUDING TB
WHICH HAS ITS OWN PROGRAM.
OUR DIVISION DAIDS JOINED FORCES
WITH DD AYE T INCLUDE ADJUVANTSR
IMMUNOGENS.
ON THE UPPER SIDE OF THIS
TIMELINE, YOU CAN SEE ACTIVITIES
FOCUS ODD ANJOU VANT SUPPORT BY
DATES AND I ADDED THE REFERENCE
TO THE SEMINAL HVTN 137 PHASE 1
STUDY ON THE EVALUATION OF THREE
DIFFERENT TLR AGONIST WITHAL UM
OR THE BG505SOSIP WHICH I WILL
SHOW LATER ON IN MORE DETAILS
ABOUT.
NOW, NOT SHOWING THIS TIMELINE,
I THINK WE'LL TRY DEVELOPMENTS
AND SOME OF WHICH DO INCLUDE A
FEW ADJUVANTS AND NON HUMAN
PRIME AT STUDIES WITH OUR
CLINICAL RESEARCH AND
DEVELOPMENT BRANCH INTENDED TO
MIRROR THE STUDY.
HOWEVER, UNTIL NOW, DAIT HAS NO
MECHANISM FOCUSED ON THE PRE
CLINICAL DEVELOPMENT OF
ADJUVANTS FORMULATIONS WHICH IS
A GAP WE HOPE FY24 CLINICAL WILL
COVER.
I WILL NOW SHOW YOU SOME
CONCLUSIONS AND HIGHLIGHTS OF
THE RECENT WORKSHOP RECORD BY
DAIDS AND THE HIV VACCINE BY ADD
VIEW VARIANT WHICH THE SUMMARY
IS PREPARED FOR PUB LA CAME IT'S
WELL DEVELOPED THE DEVELOPMENT
OF EFFECTIVE VACCINES FORMIDABLE
TASK.
AND AMONG THE UNIQUE CHALLENGES
WE ARE FACED BY THE LACK OF
EVIDENCE FOR BROAD NATIONAL
PROTECTION AND CONSEQUENTLY NO
DEFINED CORRELATES OF IMMUNITY
IN OUR PROTECTION AND THE LACK
OF A HUMAN CHALLENGED MODEL AND
IN PERFECT ANIMAL MODELS IN
VACCINES AND THERAPY.
AND AT THE SAME TIME, OUR
CURRENT UNDERSTANDING POINTS OUT
THAT THE HIV VACCINE WILL HAVE
TO PROPERLY MOBILIZE A IMMUNE
SYSTEM TO ACTIVATE THE IMMUNE
RESPONSE WHICH HAS TO BE BY MOT'
MODEL AND TCL RESPONSE.
WE BELIEVE THAT INVESTIGATION OF
THE IMMUNOGENS AND ADJUVANTS IN
COMBINATION IMPROVE THE NEW
PLATFORMS OF PIVOTAL TO SUPPORT
THE VACCINES.
BEING THAT WAY, THE INITIATIVE
WILL SUPPORT BIO MEMBER CAL AND
IMMUNE LOGICAL SYSTEM AND IN
SCREEN OF HIV IMMUNOGENS AND
ESTABLISH WITH THE GENERATE
IMPORTANT KNOWLEDGE TO FURTHER
DEVELOP THE VACCINE.
DEVELOPED IN THE PARAMETER FOR
THIS INITIATIVE, WE SPOKE WITH
HIV IMMUNO AGAIN AND ADJUVANT
DEVELOPERS ALIKE INCLUDING OUR
COLLEAGUES FROM DAIT TO EXPAND
THE NEGOTIATION THEY CHOSE
ADJUVANTS BASED ON CONVENIENCE
OR BIOCHEMICAL, BIO PHYSICAL AND
IMMUNE LOGICAL COMPARISONS SO
NEW ADJUVANTS HAVE TESTED FOR
CLINICAL AND ARE IN CLINICAL
TRIALS.
AT THE SAME TIME, ADD VIEW
DECONGESTANT DEVELOPERS ARE
RELUCTANT TO SHARE THE
PROVINCE.
THOUGH UNDER FIRE FOR
PRECONCEIVED BY PLIGHT.
AND UNFORTUNATELY, BOTH SEVERAL
NEW ADJUVANTS ARE UNDER
INVESTIGATION BY DIFFERENT
COMPANIES FOR ALL THE DISEASE
AND HIV/AIDS PRODUCTS ARE A
HIGH-RISK AND NOT TAKEN.
SO NEXT, THE QUESTION IS, HOW
CAN WE ENGAGE FRUITFUL
COLLABORATION BETWEEN HIV
IMMUNOGEN AND HIV DEVELOPERS.
PART OF THE ANSWER IS TO NETWORK
THE DIFFERENT GROUPS.
THE WORKSHOP THAT I MENTIONED A
WHILE AGO, JUMP STARTED SOME
CONVERSATIONS BETWEEN THOSE
GROUPS.
ALSO, HAVING SET ASIDE FUNDS AS
THE INITIATIVE IS AN IMPORTANT
COMPONENT OF THIS ANSWER AS WELL
AS ENGAGE SMALLER START UP
ADJUVANT DEVELOPERS WHICH IN THE
LAST DECADE, BUT ALSO DUE TO THE
SARS-CoV-2 PANDEMIC EXPANDED
THE PORTFOLIO AND FINALLY,
PROVIDE GUIDANCE OF STATE OF THE
ART ASSAYS, RELEVANT TO
ASSESSING IMMUNO AND HALF THE
PANEL OF EXPERTISE OF HIV
IMMUNOGEN DEVELOPERS.
I WANT TO SHARE ONE EXAMPLE WHY
IT'S IMPORTANT TO PROPERLY
ASSESS IMMUNOGEN FOR PURVIEWING
PRE CLINICAL DEVELOPMENT.
THE FORMULATION OF ADJUVANT AND
IMMUNOGEN, SHOULD NOT PHYSICALLY
DAMAGE THE IMMUNOGEN OR IMPEDE
ITS ABILITY TO PRESENT EPITOPES.
IT INVESTIGATED HOW SEVERAL
ADJUVANTS OF VARIOUS COMPETITION
EFFECTED EPITOPES ON TIMERS AND
WHILE MOST OF THE TASK AS SHOWN,
A CPG ADJUVANT, LED TO
CONCLUSION OF THE TIMER FOR THE
PGT145.
WITH THE LOWER BLUE-LINE
HIGHLIGHTED BY THE RED ARROW IN
THIS BOX.
FINALLY, I WANT TO PREVIOUSLY
DISCUSS THE PHASE 1 CLINICAL
TRIAL PGT145.
ON THE TABLE ON THE LEFT SHOWS
THE TRIAL DESIGN.
THE UPPER PART OF THE TABLE,
LOOK AT TWO DOSES OF THE TLR78
GIVEN INTER MUSCULARLY WITH THE
664GP140 AND THE RESORTS FROM
PART A INDICATED IT WAS SAFE TO
PROCEED TO PART B WITH FIVE
MICRO GRAMS OF THE ANTI-VANT
WHERE IT'S COMPARED TO TWO OTHER
RECEPTORS AND THE COMPARE TO BE.
NEXT.
THE TABLE WE CAN SEE ON THE
UPPER-RIGHT, YOU CAN SEE RESULTS
FROM PART A WHICH INDICATES THAT
THE FIVE MICRO GRAMS OF 3M052
ADJUVANTS IN SOME PARTICIPANTS
ALSO, BOTH DOSE OF THE EDGE
T-CELL ABLE TO SECRETE IN ALL
IL2 WITH IN VITRO WITH THE
ANTIGEN.
TWO MAIN POINTS WITH THIS LIGHT
ARM WHILE THIS IS A VERY
IMPORTANT CLINICAL TRIAL, IT'S
LIMITED COMPARE ONLY A FEW
ADJUVANTS WHICH UNDERSTANDABLE
GIVEN ITS COMPLEXITY AND COST.
BUT MAYBE MORE IMPORTANTLY,
WHILE THE 3M052 THAT'S POSITIVE
RESPONSE, THOSE PRELIMINARY
RESULTS, BEFORE PART B IS
COMPLETED, HAVE ALREADY
MOTIVATED ALL THE CLINICAL
TRIALS TO ADOPT THESE ADJUVANTS
AND THIS IS SORT OF IN YOUNG
EXAMPLE OF HOW ADJUVANT
ASSESSMENTS ARE UNDERTAKEN.
NEXT SLIDE, PLEASE.
SO, APPLICATIONS FOR THE
RATIONALE SYSTEM
CHARACTERIZATION SELECT ON
ADJUVANT FOR RESULTS ARE
CANDIDATES SHOULD PROPOSE A
SERIES OF HIV IMMUNOGEN CREATING
A MATRIX FOR ASSESSMENT OF
FORMULATIONS.
AND AS WELL AS BIOCHEMICAL
IMMUNE LOGICAL BY WHICH THOSE
FORMULATIONS WILL BE SYSTEM AS
TICKLY CHER TERRIZED BY IN THE
SCREEN AND THEY INCLUDE IN VITRO
SYSTEM AS WELL AS APPROPRIATE
ANIMAL MODELS AND FINALLY THE
INVESTIGATION SHOULD GENERATE
GO/NO-GO CRITERIA BY THE USE OF
THE METHODS.
NEXT SLIDE, PLEASE.
I WANT TO THANK THE REVIEWERS OF
OUR NEW INITIATIVES AND THE
HEALTH FOR DISCUSSION THAT
FOLLOWED DURING OUR MEETING A
FEW WEEKS AGO.
REVIEWERS ARE FRANKLY POSITIVE
AS HIV FUELS AND I QUOTE,
DESPERATELY NEEDS TO IMPROVE THE
PROCESS OF ADJUVANT DEVELOPMENT
AND A DEDICATED MECHANISM FOR
COMPARING ADJUVANTS RIGOROUSLY
IN A HEAD-TO-HEAD MANNER MAKES
SENSE.
WE RECEIVED SUGGESTIONS AND I
WANT TO SHARE THOSE.
FIRST, ABOUT COORDINATING WITH
DAIT CONTRACTS, MEETINGS, WITH
OUR INITIATIVE AND WE CONQUER
WITH THIS IDEA.
IN FACT, DAIT'S CONTRACTS DO
HAVE MEETINGS BETWEEN THE GROUPS
AND WE HAVE HAD INITIAL
CONVERSATIONS ABOUT INCLUDING
CONTRACTORS INTO DAIT'S PROGRAMS
MEETINGS TO HELP CROSS
POLLINATION AND IN EXCHANGE OF
IDEAS.
SECOND, THE SUGGESTION ABOUT
SPECIFYING THE CHARACTERISTICS
OF THE IMMUNE RESPONSE DESIRED
AND SELECT FROM A SET OF
ADJUVANTS KNOWN TO PROMOTE SUCH
ACTIVITY.
WE ALSO CONCUR WITH THIS
SUGGESTION AND THE CONTRACT CAN
HAVE LANGUAGE TO REQUIRE THE
ADJUVANTS PROPOSE THAT
COMPLIMENT THE IMMUNOGENS AND
LEAD TO THE DESIRED IMMUNE
RESPONSE.
WE BELIEVE IN FACT THAT THE
INITIAL SELECTION, IN FACT, BE
GUIDED WITH PREVIOUS EXPERIENCE
OF OTHER ANTIGENS.
AND FINALLY, A SUGGEST WILL
PROVIDING ADDITIONAL SPECIFICITY
REGARDING WHAT ASPECTS OF THE
IMMUNO MIGHT BE EVALUATED IN
COMPARISONS AND WE CONCUR AND
ALL THE MENU OF METHODOLOGY CAN
DEPEND ON THE PROPOSE A LOT AND
WE CAN USE THE HVTN ASSAY
ALGORITHM TO GUIDE IN THE
ASSESSMENTS SO IN MY LAST SLIDE,
PLEASE, SO THIS IS JUST TO
FINALIZE THIS IS THE MAIN
OBJECTIVE IS TO FACILITATE THE
COMBINATIONS AND IS A NEW BROAD
AGES ANNOUNCEMENT AND FIVE YEARS
AND THANK YOU SO MUCH AND I LOOK
FORWARD FOR YOUR QUESTIONS.
>> THANK YOU, VERY NICE
PRESENTATION.
WHILE PEOPLE THINK ABOUT
QUESTIONS, I WOULD ASK YOU TO
OPEN, REOPEN YOUR ECBs AND
VOTE ON THIS CONCEPT AND SEE IF
WE HAVE ANY QUESTIONS.
RICH --
>> IT SEEMS LIKE A DIFFICULT
CHESS GAME THAT YOU DON'T REALLY
KNOW WHERE TO START WITH THE
ADJUVANT AND MAYBE THE SUM
ADJUVANTS ARE BETTER FOR
DIFFERENTIMMUNOGENS?
>> CORRECT.
OUR RATIONALE TO PROMOTE THE
INITIATIVE THAT WAY IS TO CREATE
THIS MATRIX SO WE CAN INFACT
SELECT EXACTLY WHAT YOU ARE
ASKING ABOUT, WHO COMBINES
BETTER WITH WHO?
SO, WE STARTED WITH THIS
WELL-ACCEPTED RATIONALE THAT
EACH IMMUNOGEN AND ADJUVANT IS A
UNIQUE MARRIAGE THAT WE EXPAND
FROM ONE TO THE NEXT AND WE HAVE
THIS GENERAL IDEA THAT IF YOU
WORK WITH ONE ANTIGEN WE CAN
MOVE ON AND PLUG IN WITH THE AIM
ADJUVANT AND WE NEED TO BE
PREPARED BEFORE WE MOVE FORWARD
IN THIS FORMULATIONS TO MAKE
SURE THAT EACH ONE OF THESE
MARRIAGE, THIS ANTIGEN, THIS
ADJUVANT CAN EFFECT WORK AND WE
ARE PROPOSING THIS PRE CLINICAL
PLATFORM TO ASSESS THAT.
>> GREAT.
>> KEITH, QUESTION?
YOU ARE ON MUTE.
>> YEAH, THANK YOU.
I THINK YOU WERE IN OUR
CONVERSATION WHEN WE DISCUSSED
THIS ONE.
THANK YOU FOR A VERY NICE
RESPONSIVENESS TO SOME OF OUR
COMMENTS.
I REALLY APPRECIATE THAT.
>> I APPRECIATE YOUR COMMENTS.
IT WAS REALLY HELPFUL.
>> I GUESS, WHY I'M STILL A
LITTLE FUZZY IS SORT OF THE
CONCEPTS FOR WHAT YOU LOOK AT
AND WHAT YOU DO, DID THINGS
ORIGINATE FROM WHOEVER GETS THIS
BIG CONTRACT?
O IS THERE MECHANISMS FOR
OUTSIDE PEOPLE WITH IDEAS TO
FILTER INTO IT?
I'M STILL FUZZY ON HOW THIS
ACTUALLY GETS PROGRAMMED OUT.
>> THIS IS A BAE SO WE SHOULD
RECEIVE THE PROPOSAL AND WE GIVE
THEM LOSE PARAMETERS AND THEY
TELL US HOW THEY'LL GET THE WORK
DONE.
NOW, THEY HAVE SOME FLEXIBILITY
IN DECIDING ABOUT WHAT TO
ACCEPT.
WE CAN ACCEPT PART OF THE
PROPOSAL AND WE CAN EVEN PRE
POSE SPECIFIC COMBINATIONS OF
ADJUVANTS WE WANT TO BE PART OF
THAT COMPARISON SO THE BA
MECHANISM GIVES US FLEXIBILITY,
NOT ONLY TO ACCEPT PARTIAL, PART
OF THE PROPOSALS BUT ALSO TO
INCLUDE IF WE, AT THE TIME, WE
HAVE SOME COMPARE TO BEES AND
SOME AD ADJUVANT COMING FROM
CLINICAL TRIALS AND NON HUMAN
PRIMATES AND EXPERIMENTS THAT WE
THINK ARE RELEVANT AND WE WOULD
LIKE TO SEE BEING PERFORMED IN
THAT SPECIFIC PLATFORM.
DOES THAT ANSWER YOUR QUESTION?
THANK YOU.
>> THANK YOU, VERY MUCH.
>> THANK YOU SO MUCH.
>> OUR NEXT CONCEPT IS ENTITLED
INNOVATION FOR HIV VACCINES
DISCOVERY IHBD WILL BE PRESENTED
BY Dr. JOHN WARREN.
>> THANK YOU.
HELLO, EVERYONE.
CAN YOU HEAR ME OK?
>> YES.
>> THANK YOU, KEN.
IT'S IN DEED MY PRIVILEGE TO
REPRESENT THE VACCINE RESEARCH
PROGRAM AND ASKING FOR YOUR
APPROVAL.
FOR US TO RENEW AND REISSUE THE
INNOVATION FOR HIV VACCINE
DISCOVERY INITIATIVE.
AS MY NOW-RETIRED AND H ESTEEM L
EQUAL ALAN SHULTZ IT'S LIKELY TO
REDIVINE VIRAL HOST IMMUNOLOGY
AS WE CURRENTLY UNDERSTAND IT,
GIVEN AFTER MORE THAN 30 YEARS
OF BASIC AND CLINICAL VACCINE
RESEARCH AND EFFECTIVE VACCINE
HAS NOT BEEN ACHIEVED.
SO, THUS, THE OBJECTIVE IN THIS
RENEWAL IS TO STIMULATE NOVEL
HIGH-RISK, EYE IMPACT EARLY
DISCOVERY RESEARCH THAT MAY HAVE
SIGNIFICANT IMPACT ON THE DESIGN
DEVELOPMENT OF SUCCESSFUL
STRATEGIES FOR EFFECTIVE
VACCINES.
IT WILL USE MILESTONE DRIVEN
APPROACHES AND TO FUND
HIGH-RISK' SEARCH WHICH IS
SIGNIFICANTLY DIFFERENT FROM
MOST RO1 PROJECTS.
THE MECHANISM IS THREE-YEAR PAR
PROGRAM ANNOUNCEMENT.
WE SEE PROGRAM SET ASIDE FUNDING
OF $2 MILLION FOR FISCAL YEAR
2024.
FUNDING CAN BE ACHIEVED EITHER
WITH THIS SET-ASIDE SUPPORT OR
MEETING THE RO1 PAYLINE.
THIS INITIATIVE HAS BEEN THE
PRINCIPLE ENTRY LEVEL SOLICITED
PROGRAM WITHIN VRP THAT SUPPORTS
ENTIRELY NEW UNTESTED AIDS
VACCINE RESEARCH IDEAS.
AND AS IN PRIOR ITERATIONS IT
WILL ALSO SEEK TO PROMOTE AND
ADVANCE CAREER DEVELOPMENT BY
ATTRACTING NEW INVESTIGATORS,
EARLY STAGE PIs AND HOPEFULLY
AT-RISK PIs WITH THEIR NEW
IDEAS.
SO, IT'S IMPORTANT THEN TO
REALIZE THAT THERE REMAINS A
VITAL NEED TO CULTIVATE NEW
PARADIGMS THROUGH DISCOVERY
RESEARCH AND UNTIL AN HIV
VACCINE IS DURABLE THERE'S A AT
ANY TIME NEED FOR EARLY
DISCOVERY AND TRULY INNOVATIVE
RESEARCH AND TO FULLY LEVERAGE
THE ACCELERATED SIGNIFICANCE OF
VACCINE RESEARCH CATALYZED BY
THE COVID PANDEMIC.
THERE'S ONE NOTABLE CHANGE FROM
PRIOR INITIATIVES.
IN THAT THE PRIMARY FOCUS OF
THIS INITIATIVE, IT WILL BE IN
THIS ROW NEWELL, IT WILL BE TO
SUPPORT NOVEL EXPLORATORY
RESEARCH TOWARDS A SUCCESSFUL
VACCINE STRATEGY WITH KNOWS
PRECEDENCE IN LITERATURE AND
THOSE SECONDARILY IT WILL
CONTINUE TO CONSIDER SUPPORT FOR
WORTHY, NOVEL BASIC VACCINE
DISCOVERY RESEARCH THAT'S NOT
FULLY BEEN EXPLOITED.
SO, IN OUR PRIOR AND ACTIVE, WE
PLAN TO MANAGE THE ASSOCIATED
HIGH-RISK USING TWO STRATEGIES.
THE FIRST, IS THAT -- AND NEXT,
PLEASE.
THE FIRST IS THAT BECAUSE RO1
CAN BE COMPETITIVE IN THE RESKE
PEER REVIEW LIMITED OR ABSENCE
OF PRELIMINARY DATA IN THE
APPLICATIONS SHOULD NOT
NEGATIVELY IMPACT THE SCORE.
THIS IS SIGNIFICANTLY DIFFERENT
FROM MOST RO1 PROJECTS.
THE SECOND STRATEGY IS INCLUSION
OF GO/NO GO MILESTONES WITH
CLEAR METRICS TO BE A CHEERED BY
THE YEAR 2 PROGRESS REPORT AND
THESE WILL BE EVALUATED BY
PROGRAM BEFORE ADDITIONAL
FUNDING PROVIDED.
THIS IS A LANGUAGE STANDING USE
OF GO/NO-GO AND IT IS BACK IN
THE PROGRAM IN 2006 OR 2007.
AND BEFORE I GET TO THE
RESPONSIVE RESEARCH AREAS, I
WANT TO SAY THAT WE'VE BEEN
INSTRUCTED THAT THERE ARE NEW
REVIEW CRITERIA AND THERE ARE
THREE OF THEM NOW NOT FIVE AND
IT'S IMPORTANCE IS ONE,
FEASIBILITY AND RIGOR AS TWO AND
EXPERTISE.
I WANT TO MENTION THESE
APPLICATIONS COME IN PROPOSING
THEIR WORK FOR THE FULL FOUR
YEARS AND IF SOME DO NOT
TRANSITION INTO YEARS THREE AND
FOUR WITH FULL FUNDING THESE
INSTEAD MAY HAVE THE OPTION TO
OBTAIN NEGOTIATED SHUT DOWN
DOLLARS IN YEAR THREE WITH NO
FUNDS IN YEAR FOUR AND ANY
RESULTING SAVINGS WE GO BACK TO
PROGRAM TO SUPPORT THE NEW
GRANTS IN THE SECOND OR THIRD
YEAR.
APPLICATIONS CYCLE OF THE
THREE-YEAR PAR OR IT COULD BE
USED FOR GRANT SUPPLEMENTS.
THIS SLIDE ACTUALLY SAYS THAT
THE RESPONSIVE AREAS OF RESEARCH
AND I'LL JUST GO THROUGH THEM
QUICKLY.
THE FIRST ONE HERE IS NOVEL
VACCINE APPROACHES TO ILLICIT
DURABLE CELLULAR RESPONSES AND
HUMORAL PROTECTIVE IMMUNITY AND
I WANT TO ADD IN ADDITION WE ARE
INTERESTED IN GENERATING BREADTH
OF THESE RESPONSES SO THE TWO
HUGE DELEM AS ARE STILL IN THIS
FIELD.
AND WE ALSO WANT TO TARGET
INNATE INDUCED OR IMPRINTED
INNATE IMMUNE RESPONSES THAT CAN
BE RECALLED IN RESPONSE TO
SUBSEQUENT VACCINATIONS.
AND NOVEL STRATEGIES FOR BOTH OF
THESE KINDS OF RESPONSES AND
THEY'RE RELEVANT TO CERTAIN AN
TOM I CANAL SITES SO MUCOSAL
SITES SPECIFICALLY.
AND NEW MALL MODELS BUT THESE
HAVE TO BE SPECIFICALLY LINKED
TO A NOVEL VACCINE INTERVENTION
STRATEGY FOR PREVENTION OF
ACQUISITION OR CLEARANCE OF
VIRUS OR INFECTED CELLS.
SO, CONTINUING THE RESPONSIVE
AREAS, HE ENCOURAGE THE USE OF
CLINICAL SPECIMENS, FOR EXAMPLE,
FROM THE HVTN STUDIES TO ANSWER
QUESTION QUESTIONS ABOUT THE
IMMUNE RESPONSES.
AND WE'RE ALWAYS INTERESTED IN
EXPLORING DIFFERENT OR NEW
ENCODED TARGETS AS AND WE WANT
TO PROMOTE ARTIFICIAL
INTELLIGENCE AND MACHINE
LEARNING APPROACHES ARE
ENCOURAGED IN THIS.
SO NONRESPONSE I HAVE RESEARCH,
BASIC ONCE ARE, WE'RE NOT GOING
TO SUPPORT PRODUCT DEVELOPMENT
OR HUMAN CLINICAL TRIALS.
AND WE'RE NOT GOING TO SUPPORT
SCRIPT TIVE RESEARCH OR
STRUCTURAL STUDIES WITHOUT A
DIRECT APPLICATION TO HIV
VACCINES.
AND FAILURE OBVIOUSLY TO PROVIDE
DETAILS GOING GO/NO-GO MILESTONE
CRITERIA.
SO THE HISTORY HERE HAS JUST
BRIEFLY HAVE BEEN SIX PREVIOUSLY
IHVD SINCE 2012, THAT'S OF THE
LAST 10 YEARS WITH SIMILAR
OBJECTIVES AND 30 APPLICATIONS
WERE FUNDED IN THIS PERIOD AND
THE PRIOR THREE-YEAR PAR FOR
FISCAL YEAR '18 THROUGH '20 AND
IT FUNDED THREE APPLICATIONS
WITH SET ASIDE DOLLARS.
AND CURRENTLY ACTIVE PAR FOR
FISCAL YEARS 21-23 HAD ONE AWARD
FOR FISCAL '21 AND NONE WHY
FUNDED IN '22 AND WE HAD NO SET
ASIDE FUNDS AND NONE OF THOSE
MADE PAYLINE AND WE HAD A ROBUST
SET OF APPLICATIONS, FOR FISCAL
'23, THE CURRENT PAR IS STILL
ACTIVE AND THE RECEIPT DATE WAS
JULY AND END OF JULY THIS YEAR
AND WE RECEIVED A VERY ROBUST
SET OF APPLICATIONS AND THESE GO
TO REVIEW IN NOVEMBER.
FROM THE PREVIOUS 30 AWARDS, SIX
PROJECTS HAVE ADVANCED PASS
INNOVATION GRANT STATES TO
RECEIVE CONTINUING FUNDING VERY
RO1s OR OTHER PROJECTS WITHIN
PO1s OR ADVANCE AWARDS AND I
THINK ANGELA CHOSE SOME OF THESE
AND I'LL JUST -- SO BEFORE
CLOSING, I WANT TO NOTE TWO
PRIOR IE3D AWARDS AND THESE WERE
BOTH AWARDED IN FISCAL YEAR 2016
AND NEXT, AND THE FIRST ONE I'LL
DESCRIBE IS, THAT TO DREW WISE
MAN AT THE UNIVERSITY OF
PENNSYLVANIA WITH HIS MRNA
BANANA PARTICLE PLATFORMS AND
THIS OF COURSE, WAS, THIS IS HIS
PIONEERED FOUNDATIONAL RNA
MODIFICATION TECHNOLOGY THAT
PLAYED A CRITICAL ROLE IN BOTH
OF PFIZER BION TECH FOR COVID
AND THE SECOND ONE IS FROM LOUIS
PICKER AND THE VACCINES AND THIS
IS A VERY EXCITE TECHNOLOGY IS
ALSO BEING FOLLOWED UP IN MORE
ADVANCED PROGRAMS SUPPORTED
RESEARCH AND WE LOOK FORWARD TO
DEVELOPING THAT FURTHER.
NEXT, FINALLY.
NEXT, PLEASE.
SO, JUST A REPEAT OF THE INITIAL
SLIDE DESCRIBING ABOUT WHAT WE
WANT TO DO.
FINALLY, THE COMMENTS FROM THE
REVIEWERS.
NEXT SLIDE.
NEXT SLIDE, PLEASE.
>> BOTH WERE STRONGLY IN SUPPORT
AND HIGHLY RECOMMENDED APPROVAL
TO RENEW THIS CONCEPT AND AND
NEVER TESTED FOR THE NEXT.
AND GOT NO GO APPROACH MANAGING
THEY MIGHT NOT HAVE ACCESS AND
ONE HAS BEEN PROPOSED AND FUNDED
BEFORE REVIEWERS SUGGEST AND FOR
ADVICE CONCERNING THE NOVELTY OF
THE PROPOSED RESEARCH AND I'M
HAPPY TO TAKE YOUR QUESTIONS,
THANK YOU, VERY MUCH.
>> GREAT.
THANK YOU.
Dr. WARREN.
FOR A VERY NICE PRESENTATION.
QUESTIONS?
LET ME ASK PEOPLE AND REMIND
PEOPLE TO OPEN THEIR ECBs AND
VOTE.
YES, PAUL.
>> JOHN, HOW DID YOU COME UP
WITH THE YEARS TO FUND?
IS IT WHAT IS AVAILABLE OR IT'S
BEEN SUCCESSFUL IN THE PAST?
I MEAN I CAN IMAGINE IF YOU COME
UP WITH SOMETHING AND NOVEL AND
MAY TAKE MORE TIME TO DEVELOP.
>> YEARS TO FUND?
SO, CAN YOU BE A LITTLE MORE
SPECIFIC?
>> YOU MEAN --
>> YOU MEAN JUST WITHIN THE
FOUR-YEAR GRANT.
>> YEAH, THAT'S WHAT I MEAN.
>> SO, CURRENTLY, WHAT WE DO IS
IT GOES TO PEER REVIEW AND IT
GETS SCORED AND ADDS A TYPICAL
RO1 FUNDED THROUGH PAYLINE, FOR
EXAMPLE.
AND I SHOULD HAVE MENTIONED BY
THE WAY IF NON HUMAN PRIMATES OR
HUMANIZED MOUSE MODELS ARE USED
THE INVESTIGATORS WILL HAVE UP
TO 150,000 OR THERE ABOUTS FOR A
YEAR TO SUPPORT THOSE ACTIVITIES
AND THIS GRANT MECHANISM SO, AT
ONE POINT IN TIME, THIS GRANT
MECHANISM WAS AN R21 AND R33
WHICH WAS FIVE-YEARS TO SUPPORT
OF R33 POST TRANSITION AND IT
BECAME FIVE YEARS WITH NO
TRANSITION AND THEN WE WENT BACK
TO THE RO1 THIS TIME WITH FOUR
YEARS AND THE AMOUNTS OF MONEY
THAT WERE USED TO FUND EACH OF
THOSE DIV DIFFERENT ITERATIONS Y
BUT IT WAS CONSISTENT OVER TIME.
I DON'T THINK, I MEAN WE'RE
ASKING FOR $2 MILLION FOR THE
FIRST YEAR OF THIS NEW
THREE-YEAR PAR, BEGINNING FISCAL
YEAR 24°, IT CERTAINLY WOULD BE
NICE TO ASK FOR MORE IF THOSE
ARE AVAILABLE.
AND SOMETIMES WE CAN GET -- WE
CAN SUPPLEMENT THESE GRANTS,
TYPICAL RO1s AS WELL.
I DON'T KNOW IF THAT ANSWERED
YOUR QUESTION.
>> YEAH, THANK YOU.
>> Dr. JEROME.
>> YEAH.
JOHN, THAT'S REALLY NICE AND I
ALWAYS LOVE THE EMPHASIS ON
INNOVATION.
YOU STARTED TO ADDRESS THIS
RIGHT AT THE END.
IT STRIKES ME THAT PART OF THIS
STARTS TO INTERSECT A LITTLE BIT
WITH THE SNAP--WE HEARD ABOUT
WITH THE mRNA PLATFORMS AND
YOU CAN HANDLE THAT -- IS
SOMETHING OWN HAVE A TIVE OR NOT
IN THESE CONVERSATIONS THAT YOU
WANT TO HAVE?
IS THERE A CROSS-REFERENCE, I
DON'T KNOW IF YOU DO THIS, I
MEAN, SOMEONE LOOKS AT THIS AND
IF FOR MORE PRODUCTS OR
APPROACHES FARTHER ALONG THE
DEVELOPMENT OF THE PATHWAY MIGHT
CONSIDER THIS PROGRAM
ANNOUNCEMENT OR THIS CONCEPT AS
WELL?
>> THOUGHT I SHOULD ADDRESS THAT
QUESTION AND I THOUGHT I SHOULD
WRITE SOMETHING DOWN SO IN A
SENSE SNAP-H IS IN PART OF
COURSE HIGHLY IMPORTANT
DEVELOPMENTAL PHASE OF THE
WISEMAN PLATFORM FOR mRNA LIP
OWE NANOPARTICLES THAT I DON'T
KNOW IF YOU KNOW THIS BUT AMONG
THE 14 NIH-SUPPORTED PATENTS
SUBMITTED BY DREW WEISMAN AND
HIS GROUP AT PENN BEFORE MODERNA
WAS EVEN IN THIS FIELD, NINE OF
THOSE PATENTS CITE THIS
INNOVATION GRANT IN 2016.
SO, IT'S NOT LIKE THIS IS IN A
VACUUM.
THESE GRANTS GO SOMEWHERE.
NOT ALL OF THEM, OBVIOUSLY, MOST
OF THEM FAIL ACTUALLY, THEY
DON'T GO ANYWHERE, THEY GET
FUNDED.
BUT THEY GO SOMEWHERE AND SAME
WITH THE PICKER SCOTT HANSON
APPROACH WITH CMV I FAILED TO
MENTION THEY'RE BOTH IN CLINICAL
TRIALS, RIGHT.
IN ONE WAY OR ANOTHER.
THE GROUP IS TESTING THE CMV
VECTOR AND A LOT OF THAT WORK
WAS -- SO, IN TERMS OF SNAP-H
AND HOW IT WILL COMMUNICATE WITH
THE INNOVATION GRANT PROGRAM,
WHICH WILL WE HOPE WILL ALSO
INCLUDE FURTHER DEVELOPMENT OF
NUCLEIC ACID-BASED VACCINES NOT
JUST RNA BUT DNA WE'LL HAVE TO
SEE WHERE IT GOES.
WE WON'T TURN DOWN FURTHER
DEVELOPMENTAL ASPECTS.
I MEAN WHAT'S DREW WISEMAN DID
OVER MANY YEARS, HIS INNOVATION
GRANT THAT WAS AWARDED IN 2016,
ACTUALLY GOT TWO NO-COST
EXTENSIONS AND ITS FINAL REPORT
I JUST GOT LIKE LAST MONTH.
EVEN THOUGH IT WAS FUNDED SIX
YEARS AGO.
AND HE HAD ALSO DONE ALL KINDS
OF DEVELOPMENTAL WORK,
ESPECIALLY THE MODIFICATIONS OF
THE PSEUDO URIDINE FOR THE
INNATE SYSTEM SO I HOSTED DREW
WISEMAN IN 2014 AND HE WAS ONE
OF THE THINGS HE WAS HOT ABOUT
THEN WAS SHOWING THE
NANOPARTICLES BY THEMSELVES
COULD BE ADJUVANTS AND
INDEPENDENT OF THE mRNA SO
THAT WORK HAS BEEN TAKEN ON BY
OTHER GRANT MECHANISMS AND
EXPANDED EXTENSIVELY AND WE'RE
CERTAINLY GOING TO COMMUNICATE
THAT IF THE SNAP-H GETS TRACTION
WE HOPE TO CERTAINLY INTERACT
GOING FORWARD.
>> GREAT.
JOHN, WE HAVE A QUESTION FROM
Dr. HARRIS.
>> JUST KIND OF A COMMENT AND A
QUESTION.
SO, INNOVATION BEING KEY NOVEL
BEING KEY, MY QUESTION IS
RELATED TO KEITH'S WAY AND IT
WOULD BE REALLY NICE IF THE
DIFFERENT PROGRAMS COULD TALK
AND HELP THE PIs DETERMINE
WHICH, YOU KNOW, FOA IS MORE
APPROPRIATE FOR THEIR INNOVATIVE
PROPOSAL.
BECAUSE THERE IS ACTUALLY QUITE
A NICE THEME THAT IS EMERGING
HERE BETWEEN THEM BUT I THINK --
YOU FROZE UP.
CAN YOU HEAR ME?
>> RUBEN, YOU JUST FROZE SO YOU
WILL UNFREEZE AT SOME POINT
AND --
>> I THOUGHT I FROZE UP.
>> I'M NOT SURE WHAT HE WAS
GETTING AT.
>> WELL, HE WILL COMMUNICATE BY
CHAT AND THEN WHEN ALWAYS
FREEZES IN JUST THE MOST
WONDERFUL POSITIONS THAT WE CAN
HAVE.
ZOOM SHOULD ALLOW TO YOU CHOSE
WHEN YOU FREEZE HOW YOU FREEZE.
ALL RIGHT.
WELL, HERE HE GOES.
ARE YOU BACK?
>> SO MY BRANCH CHIEF HAS A
COMMENT IN THE CHAT THAT MAYBE
PRELIMINARY DATA IS THE KEY SO,
ONE OF THE THINGS DISCUSSED IN
OUR CALL WITH THE REVIEWERS WAS
YOU KNOW, THE DEGREE OF
PRELIMINARY DATA OR THIS IDEA
THAT THOSE KINDS OF DATA ARE NOT
NECESSARILY NEEDED FOR AN
APPLICATION FOR THIS IHVD AND IN
MY EXPERIENCE, ALL THESE GRANTS
COME IN WITH SOME PRELIMINARY
DATA AND SOMETIMES IT'S
RELEGATED TO OTHER DISEASE
SYSTEMS USING THAT APPROACH THAT
THEY WANT TO APPLY TO HIV.
SO, WE'RE VERY SERIOUS, THESE
GET REVIEWED IN BLOCK IN A BLOCK
WITHIN THE CSR/RO1 REVIEW PANEL
AND SO THESE ARE REVIEWED AS A
GROUP AND THE SRO OR THE CHAIR
IS CAREFUL TO REMIND THE
REVIEWERS OF THIS FACT THAT THE
PRELIMINARY DATA AREN'T
NECESSARILY HAVE TO BE AS
RIGOROUS AS A TYPICAL RO1.
>> GREAT.
THANK YOU Dr. WARREN AND THANK
YOU FOR REMINDING US THAT FOR
HIGH-RISK PROPOSALS, THAT SIX
MOVING ON OUST 30 IS A HIGH
YIELD AND THEN A PROGRESS BEYOND
THAT SO LET ME ASK PEOPLE TO
VOTE IF YOU HAVEN'T ALREADY
VOTED.
HOPEFULLY PEOPLE HAVE AND WE
WILL GET Dr. HARRIS BACK AT
SOME POINT.
AND I THINK WE WILL MOVE ON TO
THE LAST CONCEPT FOR THE VACCINE
RESEARCH PROGRAM ENTITLED
INTEGRATED PRE CLINICAL CLINICAL
AIDS VACCINE DEVELOPMENT IPCAVD
PROGRAM AND A U19.
WE'LL BE PRESENTED BY Dr.
VIJH.
>> THANK YOU.
CAN YOU HEAR ME?
>> YES.
>> GREAT.
HELLO, EVERYONE.
I AM GOING TO PRESENT, IT'S MY
PRIVILEGE TO PRESENT THE FISCAL
YEAR 24 CONCEPT INTEGRATED PRE
CLINICAL/CLINICAL AIDS VACCINE
DEVELOPMENT PROGRAM.
THROUGHOUT THE PRESENTATION, I
WILL USE IPCAVD TO REFER TO THE
CONCEPT.
THE IPCAVD IS A LONGSTANDING
PROGRAM INITIATED IN 1998 AND
HAS EVOLVED OVER THE YEARS TO
THE CURRENT STATE.
THIS IS A REQUEST TO COUNCIL FOR
APPROVAL OF REISSUE.
THIS IS A U19 GRANT MECHANISM.
WHICH IS ACTUALLY A CO-OPERATIVE
AGREEMENT WHICH REQUIRES
SIGNIFICANT OVERSIGHT BY
PROGRAMS.
A MINIMUM OF TWO PROJECTS THAT I
SCIENTIFIC PROJECTS AND
ADMINISTRATIVE CORE ARE
REQUIRED.
AND ONE OF THE PROJECT TEST TO
FOCUS ON MANUFACTURING.
THE FIRST YEAR TOTAL COST FOR
THIS CONCEPT IS $4 MILLION.
FOR A DURATION OF FIVE YEARS.
AND THE ANTICIPATED NUMBER OF
AWARDS IS ONE TO TWO.
THE PURPOSE OF THE REVIEW IS TO
FACILITATE TRANSLATION OF
ADVANCED HIV VACCINE CANDIDATES
FROM PRE CLINICAL STUDIES ALL
THE WAY THROUGH MANUFACTURING
REGULATORY FILING UP TO THE
POINT OF CLINICAL TESTING AND
CLINICAL TRIALS BEEN BE
SUPPORTED.
THE OBJECTIVES OF THE PROGRAM
ARE, TRANSLATION OF VACCINE
PLATFORMS THAT ILLICIT PRIMARILY
BROADLY NEUTRALIZING ANTIBODIES
AND DOWN-SELECTION OF MA CURE
HIV VACCINE CANDIDATES BY A
MULTI-DISCIPLINARY GROUP OF
EXPERTS SUCH AS IMMUNOLOGIST,
STRUCTURE BIOLOGISTS AND ANIMAL
MODELERS, AND OTHERS.
AND ANOTHER OBJECTIVE IS FOR
CLINICAL TRIAL READINESS FOR
TESTING HYPOTHESIS-DRIVEN PROOF
OF CONCEPT USING THE CGMP
MANUFACTURED PRODUCTS IN
EXPERIMENTAL TID PHASE ONE
CLINICAL TRIALS.
GIVEN THE RELUCTANCE OF INDUSTRY
TO TAKE FINANCIAL RISKS TO
INVEST IN HIV VACCINE
DEVELOPMENT, THE MAIN OBJECTIVE
OF THE IPCAVD IS TO POSTER
PARTNERSHIPS BETWEEN ACADEMIC
THAT BRINGS IDEAS AND INNOVATION
TO THE TABLE, PHARMA, BIOTECH,
CONTRACT MANUFACTURING AND
ORGANIZATION THAT'S PROVIDE THE
MANUFACTURING KNOW HOW AND DAIT
THAT PROVIDE LEADERSHIP TO INSEN
TA VIVE COMMERCIAL PARTNERS AND
DERISK HIV DEVELOPMENT.
I'D LIKE TO PROVIDE AN OVERSIGHT
OF THE TRANSLATIONAL RESEARCH
AND THE ACTIVITIES.
THIS REQUIRES MULTI-DISCIPLINARY
TEAMS FROM ALL STAKEHOLDERS
INCLUDING DAIDS, INDUSTRY AND
THE GRANTEE ORGANIZATION AND
ALSO REQUIRES EXCELLENT PROJECT
MANAGERS AND COMMUNICATION
SKILLS.
OVER SUES SOUP TO NUTS
MANUFACTURING.
IN YEARS ONE TO THREE THE
GRANTEE FOCUSES ON THE APP
TIMIZATION STUDIES IN PRE
CLINICAL MODELS COULD BE SMALL
ANIMAL MODELING LIKE TRANSGENIC
MICE AND LARGER ANIMALS LIKE NON
HUMAN PRIMATES.
THIS GOES THROUGH DOWN SELECTION
AND AS WELL AS DECISION AND
MANUFACTURE ABILITY AND THROUGH
PRE IND AS WELL AS IND ENABLING
STUDIES AND IN YEARS THREE TO
FIVE, BASED ON THE RESEARCH
GREAT EXPRESSION AND DECISION
FOR MANUFACTURING ABILITY, THERE
COULD BE LARGER SCALE RUNS THAT
TAKE PLACE AND THERE COULD BE
DEMONSTRATION RUNS AND
ENGINEERING RUNS LEADING UP TO
CGMP MANUFACTURING.
THERE'S A LOT OF OVERSIGHT OF
DEVELOPMENT OF ANALYTICAL ASSAYS
METHOD DEVELOPMENT, UPSTREAM AND
DOWNSTREAM PROCESS DEVELOPMENT,
QUALITY ASSURANCE AS WELL AS
REGULATORY AND IND APPLICATION.
THIS RESULTS IN INVENTORY,
MULTIPLE INVENTORY AS WELL AS A
CLINICAL PRODUCT THAT WILL BE
VILE AND REQUIRES SHORT TERM AND
LONG-TERM STORAGE OF PRODUCTS
AND MATERIALS AND A STABILITY
PROGRAM THAT FOLLOWS GUIDANCE.
WHEN THE PRODUCT IS AROUND
THERE'S A HAND OFF OUTSIDE THE
IPCAVD PROGRAM AND I'M SHOWING
THIS AT THE BOTTOM.
THERE'S A SEPARATION OF THE
IPCAVD ACTIVITIES FROM TESTING
IN THE CLINIC.
SO, THE IMPORTANCE OF THE IPCAVD
IT HAS FOSTERED SEVERAL AND
UNIQUE PARTNERSHIPS BETWEEN
ACADEMIC AND DAIDS THAT WOULD
NOT HAVE OCCURRED WITHOUT THIS
MECHANISM AND I WILL SHOW YOU A
FIE EXAMPLES IN THE FOLLOWING
SLIDES.
HIV VACCINE DEVELOPMENT IS AT A
CROSS ROADS.
GIVEN THE RESULTS OF 703, 703
AND 4 THE M.P. TRIALS AND 705
THE TRIALS.
THIS PRESENTS AN OPPORTUNITY FOR
US TO TAKE LESSONS LEARNED FROM
THESE TRIALS AND AS WELL AS
APPLY STATE OF THE ART
TECHNOLOGIES GIVEN THE SUCCESSES
OF THE COVID-19 VACCINE FIELD
WITH SHORTER MANUFACTURING TIME
LINES.
IT'S A STREAM LINE
INVESTIGATOR-DRIVEN APPROACH TO
ADVANCE VACCINE RESEARCH
CONCEPTS FORWARD FOR TESTING AND
THERE IS NO SIMILAR MECHANISM
THAT SUPPORTS AN
INVESTIGATOR-INITIATED UTTER A
TIVE MULTI-DISCIPLINARY TEAM
BASED TRANSLATIONAL PROGRAM THAT
IS SYSTEMATIC AND INTEGRATED AS
THE IPCAVD.
DAIDS DOES PROVIDE A
COMPLIMENTARY APPROACH WHICH IS
A CONTRACT MECHANISM THAT IS
GAP-FILLING FOR VACCINE CONCEPTS
AND IT'S A SUPPORT CONTRACT AND
IT'S TASK-ORIENTED AND IT'S A
MULTI-ID/IQ WHICH IS INDEFINITE
QUANTITY AND PTVDS CONTRACT AND
THIS ONE, THIS IS A DELIVERABLE
TO THE GOVERNMENT AND THE FUNDS
ARE NOT PROVIDED TO THE GRANTEE.
SORRY, NOT TO THE GRANTEE BUT TO
THE BIOTECH COMPANY OR ANY
INVESTIGATOR THAT MAY WANT TO
GET SOME PRODUCT FILLED AS WELL
AS DAIDS MAY DECIDE THAT THEY
WOULD LIKE SOME PRODUCT TO BE
FILLED.
NEXT SLIDE, PLEASE.
IN THE NEXT TWO SLIDES, I WILL
BE PRESENTING AN OVERVIEW OF THE
PROGRAMS IN THE LAST 15 YEARS OF
THE 24 YEARS IT HAS BEEN IN
EXISTENCE.
SINCE 1998, TO PRESENT, 33ICCAVD
AWARDS HAVE BEEN MADE AND THERE
ARE SEVEN ACTIVE AWARDS.
THE ACTIVE AWARDS ARE SHOWN IN
THE SLIDE IN THE YELLOW AS WELL
AS CORRELATES WITH A OLD TEXT OF
THE YEAR IT WAS AWARDED AND THE
YEARS THAT ARE GRAYED OUT
INDICATES THAT THE AWARD HAS
ENDED.
I WOULD ALSO LIKE TO STATE THAT
THE LINE THAT IS DIVIDING IS
BASICALLY GROUPING THE DIFFERENT
IMMUNOGEN DESIGNS SO UP ON THE
UPPER HALF YOU CAN SEE THE
VECTOR PLATFORMS WHERE THE LOWER
HALF IS DESIGN AND I WON'T MENTN
ALL THE PROGRAMS AND JUST BE
SELECTIVE TO GET THE POINT
ACROSS.
I WOULD LIKE TO FOCUS ON THE
TRANSLATIONAL OF THE HOWARD
MEDICAL CENTER PROGRAM.
Dr. RECEIVED FOUR IPCAVD AWARD
OVER THE MANY YEARS IN THE
INITIAL STAGES OF 2005, THIS WAS
A HEAD-TO-HEAD COMPARISON WITH
THE 26 ZERO TYPES THAT IS AT 26,
35, 48 TO DOWN SELECT TO AT 26
WITH CELL SUBSTRATES AND
RESULTED IN MANUFACTURING OF
SMALL SCALE PHASE 1 MATERIAL AND
IN 2008, IT SUPPORTED AR26
PLATFORM DEVELOPMENT AND SCALE
UP OF THE ADD 26 MOSAIC ENVELOPE
PROCESSES FOR PHASE 2 AND ALSO
ENGAGE THAT MADE SIGNIFICANT
FINANCIAL COMMITMENTS AT
JANSSEN.
IN 2012, THE LATER YEARS,
DEVELOP MANUFACTURING PROCESSES
FOR GENERATE B AND C FOLD ON
TRIMER AS GP140 PROTEIN BOOST
AND BY THEN, THEY HAD BOUGHT OUT
CREW SELL SO THESE EFFORTS
FOSTERED MANY PARTNERSHIPS THAT
RESULTED IN EFFICACY TRIALS AND
705 AS YOU KNOW HAS BEEN
COMPLETED.
AND 706 THAT IS CURRENT LEON
GOING, THIS IS THE TRIAL.
FURTHERMORE, AS YOU ALREADY
KNOW, THIS IS ALSO ACCELERATED
THE COVID-19 R26 PLATFORM AS A
PLUG AND PLAY WITH LESSONS
LEARNED FROM THE HIV VACCINE
FIELD.
THE PROGRAM HAS BEEN MENTIONED
PREVIOUSLY BY MY COLLEAGUES
PREVIOUSLY.
THIS IS THE OREGON HEALTH
SCIENCES.
IT WAS USED FOR FILL FINISH OF
THE DRUG SUBSTANCE AND THIS
RESULTED IN A CD8 T-CELL VACCINE
USING THE ATTENUATED HUMAN CMV
VACCINE WHICH HAS BEEN TAKEN,
THE PROCESSES FROM THESE WERE
TAKE ON BY TECHNOLOGIES TO USED
THE PRODUCT VIR IN THE 22 TRIAL
GOING ON IN COLLABORATION WITH
THE BELINDA GATES FOUNDATION.
MOVING ON, THIS IS THE PROGRAM
AND HE ENGAGE INITIALLY PARA
GONE THAT WAS BY CAT A LYNN WHO
ENGINEERED A FOUR TO SIX
NANOPARTICLE AND THIS IS A JP120
AND IT'S THE GERM LINE TARGETING
THE VRCO1.
AND THIS ENTERED INTO THE CLINIC
IN 301 IN JULY OF THIS YEAR SO
TEST THE DOSING REGIMENT USING
3M052-ALUM AND IN 2022, Dr.
KEVIN SAUNDERS WAS AVOIDED BY
THE FOR NA NANOPARTICLE PLATFOR.
I WOULD LIKE TO FOCUS BY Dr.
DAVID BARNER OF THE WEST STAR
THAT HAS PARTNERED WITH BIO
PHARMACEUTICALS OVER MANY YEARS
AND THE FINISH WAS BUN DID I IDT
RESULT INSIDE TWO DNA I AM OWE E
BEGINS AND THE OTHER
NANOPARTICLE AND THOSE WERE CO
FORMULATED WITH IL12 AS AN
ADJUVANT AND TESTED IN THE PRIME
PROTEIN BOOST.
IT WOULD BE TRIMER 4571 PROVIDED
BY THE CRC AND WITH 30M5 TOO
ALUM.
THE TWO TRIALS, 304 AND 305 WILL
START LATER THIS YEAR.
FINALLY COMING TO THE MRNA
PLATFORM, EVERYBODY IS FAMILIAR
WITH THE AWARD TO Dr. HAINES
AS WELL AS TO Dr. WAISMAN AND
Dr. HAINES WAS AWARDED TWO AND
BASICALLY TO PARTNER WITH BION
TECH, VEVONIK AND A VANITY AND
CURRENTLY THE FOCUS ON THE V3
GO-CH848 PRIME BOOST mRNA
BOOST PLATFORM.
AND AS YOU KNOW, AS YOU CAN SEE,
THESE WERE AWARDED PRIOR TO THE
SUCCESSES OF THE COVID-19
VACCINE AND THIS WAS ALSO STATED
VERY WELL BY MY COLLEAGUE, JOHN
WARREN AND THERE ARE TWO AWARDS
BY Dr. HAYNES AND Dr.
WEISSMAN AND THANK YOU TO ALL
OUR HIV SCIENTISTS AND ALL THE
MEMBERS WHO ALREADY HAVE THE
INTERNATIONAL AWARENESS AND
THESE INVESTIGATORS CAN
INFORMALLY ADVISE AND PROVIDE NO
HOW WITHOUT SHARING COMPANY
INTELLECTUAL PROPERTY WITH
ENTITIES SUCH AS AFRIGEN IN
SOUTH AFRICA AND IN THAILAND AND
THIS HAS BEEN STATED BY Dr.
FAUCI AND MY COLLEAGUE ANGELA.
FINALLY, A COUPLE OF IPCAVD
PROGRAMS DID NOT MAKE IT TO
MANUFACTURING DUE TO LACK OF
IMMUNOGEN OR EFFICACY BUT YOU
CAN SEE THE PROGRAM HAS BEEN
SUCCESSFUL AND VERY PRODUCTIVE.
I WOULD LIKE TO TOUCH UPON THE
SCOPE OF THE INITIATIVE.
ON THIS SLIDE, THE TEXT IN BOLD
SHOWS THOSE THAT ARE NEW TO THIS
PARTICULAR CONCEPT FORT FOR FISL
YEAR '24.
CONSIDERED WOULD BE SCOPE IS HIV
IMMUNOGEN DESIGNED TO IN
COMBINATION WITH INNATE OR
ADAPTIVE IMMUNE RESPONSE
STABILIZED HIV ENVELOPE PROTEIN
IMMUNOGENS DESIGNED TO MINIMIZE
RESPONSE OF OFF-TARGET
EPIDEMIOLOGI' TOPS AND PLATFORMS
AND ESPECIALLY PLATFORMS THAT
OFFER ADVANTAGES OF
DOSE-SPARRING OR ACCELERATED
MANUFACTURING PROCESSES.
PRE CLINICAL ANIMAL MODELS.
THE KNOCK-IN MICE EXPRESSING
HUMAN IMMUNO GLOBIN GENES FOR
BNABS BUT THIS TIME AROUND THE
NON HUMAN PRIMATES AND EFFICACY
OR CHALLENGE STUDIES ARE NOT
PRIOR TO AREA OF SUPPORT TO THE
IPCAVD AND IT'S PRESENTED IN A
LATER SLIDE.
THE APPLICANTS WOULD BE
ENCOURAGED TO SEEK FUNDING
THROUGH OTHER MECHANISMS THROUGH
EFFICACY STUDIES AND SUCH AS OUR
CONTRACT MECHANISM AND THE
VACCINE EVALUATION UNITS.
SO SOME OF THE NONRESPONSE I
HAVE AREAS THAT I WOULD LIKE TO
ADDRESS ARE BASED ON THE CURRENT
STATUS OF THE NIH AND THESE ARE
STUDIES WITH GP1 IMMUNOGENS
ALONE OR IN COMBINATION AND
DESIGNED TO YOU ILLICIT
PRIMARILY NON NEUTRALIZING
ANTIBODIES AND APPLICATIONS WITH
MANUFACTURE OF ADJUVANTS BECAUSE
YOU HAVE OTHER SOURCES OF
THROUGH WHICH PIs WOULD
MANUFACTURE THESE ADJUVANTS AND
DEVELOPMENT IN MANUFACTURE OF
THERAPEUTIC INTERVENTIONS.
AS I STATED EARLIER THE FUNDING
OF CLINICAL STUDIES WILL NOT BE
SUPPORTED, HOWEVER, THE
APPLICANTS WOULD BE REQUIRED TO
SUBMIT A CLINICAL DEVELOPMENT
PLAN DESCRIBING THE CLINICAL
STRATEGIES AND PRO TEN SHALL
PARTNERS FOR TESTING THE
HYPOTHESIS-DRIVEN PROOF OF
CONCEPT AND A LETTER OF SUPPORT
WOULD BE REQUIRED AND A PRODUCT
DEVELOPMENT PLAN WOULD BE
REQUIRED IN THE MANUFACTURING
PROJECT.
MILESTONE PLAN WITH NO CRITERIA
AND TIME LINES TO KEEP ON
SCHEDULE WOULD BE REQUIRED.
BASED ON EXPERIENCES OVER THE
YEARS, WITH MANY PROGRAMS, WE
HAVE ADDED THIS NEW PLAN WHICH
IS A PRODUCT STORAGE AND
STABILITY PROGRAM.
THIS WOULD BE BASICALLY TO HELP
GRANTEES BE THINKING AHEAD OF
HOW TO MANAGE THE INVENTORY THAT
IS GENERATED OUT OF THESE
PROGRAMS AND THE EXPECTATION IS
THE GROUND INSTITUTES WILL
ASSUME RESPONSIBILITY OF
SUPPORTING STORAGE AND STABILITY
PROGRAMS THAT FALL OUTSIDE THE
PROJECT PERIOD.
AS I MENTIONED EARLIER, THIS IS
A U19 WHICH IS A CO-OPERATIVE
AGREEMENT THAT REQUIRES
SIGNIFICANT OVERSIGHT BY
PROGRAMS.
AND AN EXTERNAL ADVISORY
COMMITTEE OF SCIENTIFIC EXPERTS
IS IDENTIFIED WITH PROGRAM
CONCURRENCE.
BECAUSE THE APPLICANT PROVIDES
PRE DETERMINED IMMUNO LOGICAL
MANUFACTURING GO-NO-GO CRITERIA
IT ALLOWS MONITORING BUDGET FOR
CGMP MANUFACTURING THAT COULD BE
LIMITED IF THE MILESTONES ARE
NOT MET.
AND PROGRAM ASSESS READINESS FOR
GNP MANUFACTURING AT THE END OF
YEAR 2 TO NISH MANUFACTURING IN
YEAR THREE.
WE WANT TO SEE THIS AS A SLIGHT
ACCELERATION BECAUSE WE WILL
MONITOR IT AND HOPE THAT THE
MANUFACTURING CAN BEGIN EARLIER
IN THE YEAR OF THREE RATHER THAN
LATE YEAR THREE.
SO I'D LIKE TO REVIEWERS -- I'D
LIKE TO THANK OUR REVIEWERS TO
MAKE THIS PROBABLY A BETTER
PRESENTATION.
BOTH REVIEWERS EXPRESSED SUPPORT
FOR THIS PROGRAM AS PROPOSED.
AND I'D LIKE TO QUOTE FROM ONE
OF THE REVIEWERS, THIS IS AN
IMPORTANT PROGRAM WITH A LOT OF
SUCCESSES WITH INTERESTING
PRODUCTS MOVING FORWARD.
DEVELOPING A VACCINE IS AN
ENORMOUS CHALLENGE CAN YOU CAN
POINT TO A LOT OF UNIQUE
EXPERIMENTAL APPROACHES FROM THE
PROGRAM.
THIS PROGRAM IS VITAL AND AMONG
OUR BEST HOPES OF HAVING
SOMETHING THAT COULD DEVELOP
INTO AN EFFECTIVE HIV VACCINE.
AND WE COULDN'T HAVE SAID IT
BETTER AND WE TOTALLY, THIS IS
HOW WE FEEL ABOUT THIS PROGRAM
AND THANK YOU FOR THE OPTIMISM.
ONE OF THE REVIEWERS EMPHASIZED
THAT THE CLINICAL TRIAL TIMELINE
AND FUNDING IS SEPARATE FROM THE
IPCVED AND IT SHOULD BE NOTED
AND WE BELIEVE WE HAVE ADDRESSED
IT IN THE PRESENTATION.
THERE SEEMS TO BE A BIG EMPHASIS
ON THE MANUFACTURING AND HOW
MATURE IS THE CONCEPT AT THE
TIME THE PRODUCTS ARE PRODUCED
FOR CLINICAL STUDIES.
BASICALLY THE SUPPORT ADVANCED
IMMUNOGENS BEYOND BASIC
DISCOVERY AND FURTHER ALONG IN
RESEARCH AND DEVELOPMENT AND
CONCEPTS SHOULD INCLUDE WELL
CHARACTERIZED PRODUCT AND
PROCESS THAT'S CAN GENERATE
DESIGN RAT TRA BEAUT SCALE FOR
MANUFACTURING WHAT IS THE REASON
TO LIMIT THE STUDIES AND THIS IS
WHAT I ALLUDED TO EARLIER.
SO THERE ARE OTHER FUNDING
MECHANISMS IN DAIDS TO SUPPORT
EFFICACY STUDIES IN ENERGY AND
CHALLENGE STUDIES CAN TAKE 18
MONTHS TO TWO YEARS AND NEED TO
BE REPEATED FOR REPRODUCIBILITY.
EFFICACY STUDIES ARE NOT
INCLUDED DUE TO THE NEED TO
ACCELERATE MANUFACTURING TIME
LINES.
FURTHERMORE, RESULTS FROM THE
NHP STUDY DID NOT TRANSLATE INTO
THE CLINIC FOR HVTN705 AND THE
USER OF KNOCK-IN MICE EXPRESSING
HUMAN ANTIBODIES GENES HAVE
SUPPORTED TRANSLATION OF
CONCEPTS, WITH AN IMMUNOGEN THAT
TARGETS CD4 BINDING CITE
LINEAGES INTO THE CLINIC AND SO
WE NEED TO STRIKE A BALANCE
BETWEEN THESE TYPE OF STUDIES.
IS IT S THERE AN OBLIGATION FOR
CLINICAL TRIALS THAT HAVE
ADVANCED WITH THIS PROGRAM?
9 APPLICANTS ARE REQUIRED TO
INCLUDE A DEVELOPMENT PLAN IN
THE APPLICATION.
THEY MUST IDENTIFY POTENTIAL
CLINICAL PARTNERS, IT DOESN'T
HAVE TO BE A NETWORK PARTNER.
THERE'S NO OBLIGATION FOR THE
GRANTEE TO USE THE HVTN TO
CONDUCT THE TRIAL AND WHAT KIND
OF TRY TERRIA TARGET NEEDS TO BE
MET BY THE PRODUCT TO BE A
VIABLE CANDIDATE FOR THIS
FUNDING MECHANISM?
IT DOES NOT SPECIFY OR PROVIDE A
CUSTOMIZED LIST OF TARGET
ATTRIBUTES OF TARGETS BECAUSE
THE GOAL OF THE IPCAVD IS TO
SUPPORT INNOVATIVE PROOF OF
CONCEPTS FOR MANUFACTURING HIV
CANDIDATES FOR CLINICAL TESTING.
THIS BRINGS ME BACK TO THE SLIDE
WHERE I REQUEST COUNCIL FOR
APPROVAL OF REISSUE OF THIS
LONGSTANDING WE BELIEVE
PRODUCTIVE PROGRAM AND THANK YOU
FOR YOUR ATTENTION.
>> THANK YOU, VERY MUCH.
VERY INTERESTING AND THANK YOU
FOR SHARING THE HISTORY OF THE
MANY SUCCESSES THAT HAVE COME
THROUGH THIS PROGRAM TO DATE.
LET ME ASK EVERYONE TO REOPEN
THEIR ECBs AND TO VOTE ON THIS
CONCEPT AND HAPPY TO TAKE
ADDITIONAL QUESTIONS THAT PEOPLE
MAY HAVE.
I UNDERSTAND THE RESISTANCE TO
HAVING NHP CHARGE STUDIES BUT, I
GUESS THAT INFORMATION IS NEEDED
A LOT OF TIMES BEFORE THIS WILL
GO INTO A CLINICAL STUDY, IS
THAT CORRECT OR NOT CORRECT?
>> WE HAVE EXAMPLES OF IT BEING
TRANSLATED IN SOME STUDIES AND
SOME STUDIES THEY'RE NOT
TRANSLATED SO WE NEED TO STRIKE
A BALANCE.
I MEAN, I CAN SENSE THAT FOR IT
IS DEFINITELY HELPFUL TO HAVE AN
STUDY THAT CAN BE REPEATED AND
THEN TAKE THE PRODUCT TO THE
CLINIC.
BUT THAT WOULD BE REALLY LONG
PROGRAM.
>> AND THEN A RELATED QUESTION,
SOMETIMES WE'VE HAD HISTORICALLY
REAL DIFFICULTIES IN
MANUFACTURING PRODUCTS AND THIS,
I GUESS IT'S RELATED TO WHY YOU
DON'T WANT THESE NHP CHALLENGE
STUDIES BUT I ASSUME, HAVE YOU
HAD TO WORK IN PREVIOUSLY WITH
THESE GROUPS WHERE THE
MANUFACTURE DIDN'T GO QUITE AS
PLANNED?
AND IS THERE FLEXIBILITY THERE?
>> FLEXIBILITY FOR WHAT?
>> WELL, IF THEY NEED MORE TIME
OR AN EXTENSION, THAT WOULD GO
BACK TO THIS COUNCIL OR
SOMETHING LIKE THAT?
>> I MEAN, IT DOES TAKE A LONG
TIME FOR THESE PROGRAMS TO COME
THROUGH, ESPECIALLY FOR BUY
LOGICS AND PROTEINS.
THE mRNA AND DNAs ARE A
LITTLE BIT FASTER BUT THEN EVEN
GIVEN THE WAY WE FUNCTION
THROUGH A GOVERNMENT GRANT
MECHANISM, THERE ARE SO MANY
ISSUES THAT COULD CHARGES THAT
WOULD COME UP, FOR EXAMPLE, THE
INSTITUTIONS AND THEY COULD BE
SOME LEGAL IMPLICATIONS WHEN
THEY ARE TRYING TO NEGOTIATE
CONTRACTS TO BE AGREEMENTS WITH
MANUFACTURERS AND THEN IT'S FOR
EXAMPLE THE COVID PANDEMIC
CREATED A TIGHT SUPPLY CHAIN
ISSUE AND THERE WAS LACK OF
MATERIALS THAT WAS NEEDED SO ALL
OF THESE CAN ADD DELAYS TO THE
PROGRAM SO THEY END UPTAKING A
WHILE AND I MEAN THEY DO GO INTO
NO COST EXTENSIONS SO OUR
ATTEMPT AT THIS FUNDING OPTION
ANNOUNCEMENT ROUND IS TO TRY TO
KIND OF SHORTEN THE TIMELINE SO
WE DON'T GO INTO SEVEN YEARS OF
PROGRAMS AND YES, THERE ARE
ISSUES OF MANUFACTURING THAT ARE
A COUPLE OF PROGRAMS THAT DID
NOT MAKE IT INTO THE
MANUFACTURING ITSELF AND YOU
KNOW, SOME OF THEM HAVE ENDED
EARLIER BECAUSE THE GROUND ENDED
BUT WE COULDN'T FINISH GMP
BECAUSE THE PRODUCT DID NOT GET
TO THE AMOUNT THAT WE WANTED TO
THE PURITY AS WELL AS THE
QUALITY OR WE COULDN'T GET
ENOUGH MATERIALS FOR THE CLINIC.
SO WHY WANT TO NAME SPECIFIC
PROGRAMS, BUT, YES, THERE ARE
ALL SORTS OF SITUATIONS AND
THERE'S NO ONE SPECIFIC PROGRAM
THAT IS LIKE THE OTHER.
>> THANK YOU.
Dr. DEIN.
DIEFFENBACH.>> WE HAVE A PRO BUM
FOR PRIME AT REEVALUATION.
THERE ARE WAYS TO GET DOWN
WITHOUT BEING PART OF THIS GRANT
AND THAT'S THE POINT, WE HAVE
FLEXIBILITY.
THIS IS FOCUSED ON MANUFACTURE
AND GETTING TOWARDS CLINIC AND
THE IT COULD BE ELSEWHERE.
>> THANK YOU.
OTHER QUESTIONS OR THOUGHTS THAT
PEOPLE HAVE, PLEASE, VOTE.
VOTE EARLY AND OFTEN HERE.
>> THANK YOU, Dr. DIEFFENBACH
AND COUNCIL.
OUR LAST CONCEPT WE'RE SWITCHING
FROM THE VACCINE PROGRAM TO A
NEW INITIATIVE.
THE NIH MEDICAL SCIENTIST
PARTNERSHIP PROGRAM WILL BE
PRESENTED BY Dr. MATTHEW
FENTON.
>> GREAT.
THANK YOU.
AND I WANT TO THANK THE
COMMITTEE FOR THE TIME TODAY TO
PRESENT THIS BRAND NEW TRANS NIH
INITIATIVE THAT WE'RE CALLING
THE NIH MEDICAL SCIENTIST
PARTNERSHIP PROGRAM OR MSPP.
SO IT'S BEEN LONG RECOGNIZED IN
ACADEMIA AND BY NIH THAT WE
REALLY NEED TO HAVE CONCERTED
EFFORT TO GROW THE HIGHLY
VALUABLE PHYSICIAN SCIENTIST
PIPELINE THAT THIS IS A GREAT OF
SCIENTISTS THAT REALLY NEED
EXTRA SUPPORT AND EXTRA
OPPORTUNITIES FOR WHICH TO ENTER
THE BIOMEDICAL WORKFORCE.
AND THERE ARE ALREADY SEVERAL
EXISTING WELL-SUPPORTED AND
HIGHLY FUNCTIONAL PROGRAMS AT
NIH THAT SUPPORT PHYSICIAN
SCIENTISTS BUT THERE'S ALSO THE
OPPORTUNITY TO HE CAN PANNED THE
KIND OF SUPPORT THAT NIH CAN
PROVIDE WE ARE SUPPORT
PHYSICIANS SCIENTISTS AND
TRAINING THROUGH THE MEDICAL
SCIENTISTS TRAINING PROGRAM OR
NSTP AND THIS IS A T32 BASED
PROGRAM THAT IS LED BY NIGMS AND
THERE'S THE RELATIVELY NEW STARS
AND STARTS PROGRAM WHICH SAY
RESEARCH AND RESIDENCY PROGRAM
AND NIAID IT'S SEV ITSELF HAS AN
SCIENTIST PATHWAY TO
INDEPENDENCE AWARD AUGUS A USIND
R00 AND THE F30 COMBINED DEGREE
NRSA FELLOWSHIP.
NOW, SINCE AROUND 2006, OVER 300
COMBINED DEGREES STUDENTS
LARGELY IN PARTNERSHIP WITH THE
MSTP UNIVERSITIES, HAVE PERSUADE
THEIR PHD DISSERTATION RESEARCH
IN NIH INTRAMURAL LABORATORIES
AND THEY'VE GONE ON TO
SUCCESSFUL CAREERS IN BIOMEDICAL
AND CLINICAL RESEARCH.
SO, WE FELT THERE WAS AN
OPPORTUNITY TO EXPAND THIS NIH
SUPPORT BEYOND JUST THE 53MSTP
UNIVERSITIES TO INCLUDE
ADDITIONAL MEDICAL DENTAL AND
VET SCHOOLS IN THE U.S.
THE MSPP IS DESIGNED TO PROVIDE
A PATHWAY TO ATTRACT TRAINEES
WHO ARE WOMEN AND UNDER
REPRESENTED MINORITIES.
THIS STUDENTS WISHING TO DO
THEIR DISSERTATION RESEARCH IN A
INTRAMURAL LABORATORY AND THE
GOAL IS TO BUILD A PIPELINE OF
TALENT FOR NOT ONLY THE IRP
ITSELF BUT LATER FOR THE
BIOMEDICAL WORKFORCE AS A WHOLE.
AND THE MSPP WILL ACCEPT
APPLICATIONS FROM STUDENTS WHO
WILL BE ATTENDING SCHOOLS AND
THAT BOTH DO AND DO NOT HAVE
EXISTING COMBINED DEGREE
PROGRAMS.
AND THAT MAKES IT QUITE DISTINCT
FROM THE OLDER MSTP PROGRAM.
AND WE ANTICIPATE THAT THE
PROGRAM WILL OPEN UP BROAD
POTENTIAL SOURCE OF COMBINED
DEGREES STUDENTS AND INCLUDING
THOSE ATTENDING HBCUs AND
MSIs.
THE NIAID WILL BE THE NATIONAL
LEAD INSTITUTE AND COORDINATE
WITH THE OTHER PARTICIPATING
INSTITUTES AND WE EXPECT THEY'LL
BE BETWEEN 12 AND 16 ADDITIONAL
ICs THAT WILL JOIN ON TO THIS
PROGRAM.
THE MSPP WILL USE A COMPLETELY
NEW FELLOWSHIP GRANT MECHANISM
CALLED THE FM1 GRANT.
THAT IT'S BASED ON INDIVIDUAL
RATHER THAN INSTITUTIONAL
CRITERIA LIKE THE T32 AND THE
MSTP PROGRAM.
THE INITIATIVE WILL HAVE A
SINGLE ANNUAL RECEIPT DATE IN
AUGUST AND IT WILL ACCOMMODATE
TWO TRACKS DEPENDING ON WHETHER
THE STUDENT OR POSTBAC APPLIES
BEFORE OR AFTER ACCEPTANCE TO
MEDICAL, DENTAL OR VETERINARY
SCHOOL.
UNDER GRADS AND POST PACKS WILL
APPLY USING NIAID AS THE
APPLICANT ORGANIZATION SAUL
THOUGH THE AWARD WILL BE MADE BY
THE STUDENTS' RESEARCH INSTITUTE
OR CENTER EXTRAMURAL DIVISION TO
THE STUDENTS MEDICAL, DENTAL OR
VETERINARY SCHOOL AND WE'RE
NEGOTIATING WITH CSR NOW TO
REVIEW THE APPLICATIONS AND
SPECIAL EMPHASIS PANEL.
NEXT SLIDE.
SO, THIS IS IT A TIMELINE AND
MAP FOR THE TWO TRACKS.
TRACK ONE WHERE THE STUDENTS
WILL GET THE AWARD AS THEY'RE
GETTING READY TO ENTER THEIR
CLINICAL DEGREE SCHOOLS WHEN
THEY MATRICULATE AND TRACK TWO
IS ESSENTIALLY A NEAR LATER AS
THE STUDENTS THEY GET THE AWARD
AS THEY'RE BEGINNING THEIR
SECOND YEAR IN MEDICAL, DENTAL
OR VET SCHOOL.
AND WHEN THEY'VE COMPLETED THE
FIRST TWO YEARS, THEN THE
STUDENT TAKES A LEAVE OF ABSENCE
AND THEY PHYSICALLY MOVE TO
TRACTOR-TRATOTHE TRAIN MURAL WHY
FOUR-YEAR PERIOD AND AT THAT
POINT THE MSPP GRANT IS ON HOLD.
AND THEN THEY'RE GETTING READY
TO START THE THIRD YEAR OF THEIR
CLINICAL TRAINING, THE INSTITUTE
THEN WILL AWARD AN EXTENSION, A
TYPE 4 GRANT, WHICH WILL SUPPORT
THEIR LAST TWO YEARS OF THEIR
CLINICAL TRAINING.
THIS IS TRACK 1 FOR POST BACKS
AND RISING SENIORS IN COLLEGE.
AND THEY HAVE THE AUGUST RECEIPT
DATE AND THEN SHORTLY
AFTERWARDS, THEY NEED TO APPLY
SEPARATELY THROUGH AN
INDEPENDENT PROCESS THROUGH THE
INTRAMURAL GRADUATE PARTNERSHIP
PROGRAM AND THEY PORTAL FOR THAT
PROGRAM OPENS FOR APPLICATIONS
IN AUGUST THROUGH NOVEMBER.
WE WOULD THEN CONDUCT PEER
REVIEW BETWEEN OCTOBER AND
NOVEMBER OF THAT YEAR AND THE
COUNCIL JANUARY NIAID COUNCIL
WILL APPROVE THE APPLICATIONS
AND WE CAN ISSUE THOSE STUDENTS
WHAT WE CALL AN APPROVAL LETTER,
WHICH SIMPLY SAYS THEY'RE
ELIGIBLE FOR FUNDING BUT THE
STUDENT CAN USE THAT TO THEN
SUBMIT TO THE IRP PROGRAM AS
PART OF THEIR APPLICATION
PACKAGE.
IRP PROGRAM INTERVIEWS ALL OF
THEIR CANDIDATES IN FEBRUARY AND
MAKES A DECISION BY THE END OF
THAT MONTH.
AND THEN NIAID WOULD AT THAT
POINT, TRANSFER THE GRANT TO THE
FUTURE INSTITUTE WHEN THEY HAVE
THE INTRAMURAL LAB AND THEREFORE
KNOW WHICH INSTITUTE WILL MAKE
YOU THE AWARD AND WE HAVE TO GO
TO THAT INSTITUTES COUNCIL AND
MAY OR JUNE AND THEN WE GET
FINAL JUST IN TIME INFORMATION
AND MAKE THAT IC WILL MAKE THE
AWARD IN JULY OF THAT YEAR.
AS THEY'RE GETTING READY TO
MATRICULATE INTO MEDICAL SCHOOL.
NEXT SLIDE.
TRACK TWO IS ESSENTIALLY THE
SAME TIMING AND STEPS AND THE
STUDENT WILL APPLIANCE AND
DENTAL OR VET AND IN THEIR YEAR
AND THEY WOULD THEN GET AT WARD
IN JUNE OR FULL AFTER FINISHING
THEIR FIRST YEAR OF SCHOOL AND
THEY WOULD RECEIVE SUPPORT FOR
THEY SECOND AND THIRD AND FOURTH
YEARS OF SCHOOL.
NOW, SPEAKING OF THE REVIEW
CRITERIA, SINCE THE TRACK ONE
STUDENTS WILL NOT KNOW WHICH
SCHOOL THEY'LL ATTEND AND WHICH
LAB THEY'LL WORK WITH AT THE
TIME OF APPLICATION, THIS
FELLOWSHIP APPLICATION, UNLIKE
MOST NIH FELLOWSHIP
APPLICATIONS, WILL NOT REQUIRE
RESEARCH PROPOSALS OR THE
IDENTIFICATION OF A DISSERTATION
MENTOR.
WHILE TRACK STUDENTS MOST LIKELY
WILL MOW THE ANSWER TO THOSE
QUESTIONS AT THE TIME THEY
SUBMIT, WILL STILL PROPOSE THAT
THE REVIEW CRITERIA BE THE SAME
FOR BOTH TRACK ONE AND TRACK TWO
STUDENTS FOR FAIRNESS.
AT SCIENTIFIC MEETINGS AND THE
STUDENTS' STATEMENT OF
COMMITMENT AND INTEREST IN A
CAREER IN BIOMEDICAL RESEARCH
AND LASTLY THE STRENGTHS OF
THREE LETTERS OF
RECOMMENDATIONS.
THE COST OF THE PROGRAM IS
DESIGNED TO BE ROUGHLY EQUAL TO
THE CURRENT COST THAT WE HAVE
UNDER THE MSTP PROGRAM AND IT'S
BASICALLY AROUND 57,000 A YEAR
CURRENTLY FOR EACH YEAR OF
EXTRAMURAL SUPPORT BUT THIS IS
BASED ON THE NSRA STIPEND
GUIDELINES SO THAT COST WILL GO
UP AS THE STAPENS GO UP EVERY
FEW YEARS, I'M SURE YOU ARE
AWARE OF THOSE CHANGES IN
STIPEND.
THE STUDENTS TAKES A LEAVE OF
ABSENCE FROM SCHOOL AND FUNDING
UNDER THE FM1 GRANT AND THE
INTRAMURAL PROGRAM ACTUALLY
HIRES THAT STUDENT AS AN FELLOW
AND COVERS ALL OF THEIR COST AND
SALARY DURING THE DURATION OF
THIS PHASE.
IT'S GOING TO BE IMPORTANT, ONCE
WE ANNOUNCE THIS NEW TISH TIVE
FOR NIAID AND OUR IC PARTNERS TO
LAUNCH SEVERAL OUTREACH
ACTIVITIES.
AND INCLUDING PROVIDING PROGRAM
INFORMATION ON OUR WEBSITE AND
OUR PARTNERS ICs' WEB SITES BY
PROVIDING WEBINARS AND WORKSHOPS
AND AN INSTRUCTION MANUAL FOR
APPLICANTS TO HELP WALK THEM
THROUGH THE NIH APPLICATIONS
PROCESS.
AND WE NEED TO HAVE GREAT
OUTREACH TO MEDICAL SCHOOLS AND
UNDERGRADUATE INSTITUTION AND
PROFESSIONAL SOCIETIES.
SO I THANK YOU FOR YOUR TIME AND
I'M HAPPY TO TAKE ANY QUESTIONS.
>> THANK YOU, Dr. FENTON.
VERY EXCITING, EXCITING PROGRAM
THAT I THINK WILL GENERATE
TREMENDOUS INTEREST.
WE HAVE TIME FOR SOME QUESTIONS.
>> SO, I KNOW I'VE ASKED A LOT
OF QUESTIONS AND --
>> KEEP ASKING.
>> I'M CONFUSED.
IF YOU ADMIT OR GIVE A GRANT TO
AN MSTP STUDENTS, WHAT HAPPENS
TO THE MONEY?
DO YOU SHARE THE COST OF THAT
WITH THE INSTITUTION?
OR DOES THIS PROGRAM TAKE OVER
THAT COST?
>> WELL, FIRST OF ALL, THE MSTP
PROGRAM IS SUNSETTING ITS OPTION
OF ALLOWING STUDENTS TO DO THEIR
DISSERTATION RESEARCH AT THE NIH
CAMPUS.
SO THIS PROGRAM IS SUBSTITUTING
FOR THAT.
BUT THE WAY IT IS WORKED IN THE
PAST, IS THAT UNDER THE MSTP,
THE INSTITUTION RECEIVES A T-32
GRANT WITH A CERTAIN NUMBER OF
SLOTS AND THE FUNDS TO SUPPORT
THOSE SLOTS.
THE STUDENT THAT MATRICULATE GET
INTO A SLOT AND IF THAT --
AGAIN, THE T32 IS HOUSED AT
NIGMS SO LET'S SAY A STUDENT
WANTS TO DO A MIKE OWE BIOLOGY
DISSERTAT
DISSERTATION, NIAID WOULD PAY
FOR THE STUDENT DURING THEIR
FOUR YEARS OF SCHOOLING.
>> UNDER THE MSPP PROGRAM, WE'RE
JUST SIMPLY PAYING DIRECTLY.
IT'S AN INDIVIDUAL FELLOWSHIP
GRANT AND BE WE'RE NOT PAYING
THROUGH A T32.
>> Dr. GANDHI, QUESTION.
>> YEAH, I MEAN, I ASKED THIS
BEFORE BUT I'M TRYING TO
UNDERSTAND THAT DOES THIS HE CAD
TO NON MEDICAL PH.Ds IN
PHARMACY, DENTAL?
IN A WAY AND NURSING, IN A WAY
THAT WE DIDN'T, THAT THE MSTP
DIDN'T SERVE?
>> WELL, WE'RE DEFINITELY GOING
TO BE INCLUDING MEDICAL, DENTAL
AND VETERINARY.
WE WILL LIKELY INCLUDE SOME OF
THE OTHER CLINICAL DOCTOR ATS
BUT ONE OF THE QUESTION THAT
COME UP RECENTLY ABOUT RNs AND
WHETHER THIS WOULD BE AN RN PH.D
OPPORTUNITY.
BECAUSE OF THE GRANT MECHANISM,
IT HAS TO BE A COMBINED DOCTORAL
DEGREE SO, IT WOULDN'T BE A
PATHWAY FOR SOMEONE WHO WANTED
DO AN RN, PH.D, THEY WOULD HAVE
TO GO THROUGH THE REGULAR THD
FELLOWSHIP GRANT PATHWAY TO DO
THAT.
>> THANK YOU.
>> CAN I ASK YOU TWO QUESTIONS.
IN THE FOUR CRITERIA YOU LISTED
I DON'T BELIEVE THAT DIVERSITY
WAS ONE OF THOSE CRITERIA
PERHAPS IT WAS.
WHAT I WANT TODAY ASK AND THIS
CAME UP EARLIER, HOW FOR THE T32
IT'S CRITERIA FOR SUCCESS AND
THE PROGRAM.
WILL THAT BE VIEWED IN THIS
PROGRAM INTERNALLY AS ONE OF THE
CRITERIA IN EVALUATING THE
APPLICATIONS IS THE FIRST
QUESTION AND THE SECOND, I
HADN'T REALIZED BEFORE YOU
PRESENTED THERE WAS NO RESEARCH
PROPOSAL NOTED SO HOW WILL
APPLICANTS AND REVIEWERS KNOW
WHERE SOMEONE MIGHT END UP OR IS
THIS TO FIND COMMITTED PEOPLE
WHO HAVE DONE RESEARCH AND
EXPECT THEY WILL FIND A GOOD
PLACE TO GO?
>> LET ME ANSWER YOUR SECOND
QUESTION FIRST IF I COULD.
IF YOU THINK ABOUT A STUDENT
COMING INTO THE MSTP PROGRAM,
THEY GET A SLOT ON A T32.
THEY HAVE NO IDEA WHAT THEIR
RESEARCH PROJECT IS GOING TO BE,
WHO THEIR MENTOR IS GOING TO BE,
WHETHER IT'S IN THE INTRAMURAL
PROGRAM OR NOT.
SO THIS ISN'T ALL THAT
DIFFERENT.
WE DO PUT -- WE WILL PUT IN THE
FOA A DESCRIPTION OF THE
RESEARCHES AVAILABLE THROUGH THE
INTRAMURAL PROGRAM AND I THINK
EVERYBODY'S AWARE OF
HIGH-QUALITY RESEARCH THAT IT
TAKES PLACE AT THE NIH CAMPUS.
BUT, THIS IS GOING TO BE VERY
SIMILAR TO THE EXISTING PROGRAM
SINCE A STUDENT ON A T32 SLOT IN
THE MSTP WILL BE IDENTIFIED A
MENTOR IN A RESEARCH PROJECT IN
THE COURSE OF THEIR FIRST YEAR
IN MEDICAL SCHOOL.
AS FAR AS YOUR FIRST QUESTION, I
WOULD RATHER HAVE YOU TALK TO MY
LAWYER.
THE ANSWER IS, IS THAT IF YOU
ARE DOING AN INTERN -- AN
INSTITUTIONAL GRANT, WE CAN
ENCOURAGE INSTITUTIONS THROUGH
THE FOA TO DO THEIR BEST TO
ENCOURAGE AND SUPPORT DIEA AND
IN THEIR RECRUITMENT PRACTICES.
WE CANNOT MAKE AN AWARD BASED ON
RACE, SEX, GENDER OR ANY OF
THOSE CRITERIA.
LEGALLY WE'RE NOT ALLOWED TO DO
THAT.
BY SAYING THAT WE WANT THIS
PROGRAM TO -- WE ENCOURAGE
SCHOOLS HBCUs AND MSIs TO
PARTICIPATE IN THE PROGRAM BY
OPENING IT UP TO SCHOOLS OUTSIDE
OF THE MSTP PROGRAMS TO REACH
OUT TO MORE DIVERSE COLLEGES AND
UNIVERSITIES.
WE'RE HOPING THAT WE WILL
AUTOMATICALLY INCREASE THE
DIVERSITY OF THE APPLICANT POOL
BY DOING THAT BUT WE ACTUALLY
CAN'T TAKE RACE, SEX, GENDER AND
INTO ACCOUNT AND DETERMINING
FUNDING.
>> THANK YOU.
THAT'S HELPFUL AND I DO THINK
THAT BY FOCUSING ON A DIVERSE
SET OF RESEARCH EXPERIENCES, AND
VARIOUS POPULATIONS THAT THAT
CAN BE EXPANDED QUITE WELL.
SO, I THINK THAT CAN BE
SUCCESSFUL.
MONICA, DO YOU HAVE NUR Y YOU
ARE HAND UP AGAIN OR STILL IN
UP?
OR MAYBE NOT AT ALL.
I DON'T KNOW.
>> SO STU FOR THIS PROGRAM AND
FOR WE ALL AGREE NEEDING
HIGH-QUALITY PHYSICIAN
SCIENTISTS VETERINARY AS WELL AS
DENTAL WILL BE REALLY VALUE-ADD.
QUESTION ABOUT QUESTIONS WILL
TOPIC AREAS WILL THERE BE SOME
ATTEMPT TO SORT OF IDENTIFY
PARTICULAR HIGH VALUE AREAS THAT
ARE NEEDED BY THE NIH AND ARE
ALIGNED WITH THE PRIORITIES THAT
WILL BE GIVEN PREFERENCE?
I KNOW YOU MENTIONED THAT THERE
MAY NOT BE A CLEAR PATH TO
SELECT THE AREAS OF STUDINESSLY
AND JUST CURIOUS AROUND THE
TOPIC AREAS THAT WOULD BE
PRIORITIZE THE?
>> WELL, YOU KNOW, THE ABILITY
TO DO THAT PRIORITIZATION IS
LIMITED GIVEN THAT WE DON'T
REQUIRE A RESEARCH PROJECT TO BE
PROPOSED IN THE GRANT
APPLICATION ITSELF.
AND AS I SAID BEFORE, AS WE
DISCUSSED, AT THE TIME THESE
APPLICATIONS ARE REVIEWED, FOR
AT LEAST FOR THE TRACK ONE
STUDENTS, THAT THEY WON'T HAVE A
CLEAR ANSWER FOR WHERE THEIR
MENTOR AND HOME INSTITUTIONS
WILL BE IN THE INTRAMURAL
PROGRAM AND CHANCES ARE, THEY'RE
VERY LIKELY TO KNOW THE TYPES OF
RESEARCH THAT THEY'RE INTERESTED
IN AND A LOT OF THESE STUDENTS
ARE GOING TO HAVE PRIOR RESEARCH
EXPERIENCE AND HAVE VERY STRONG
IDEAS AT LEAST UP FRONT, OF
WHERE THEY THINK THEY MIGHT WANT
TO WORK IN TERMS OF THEIR
SCIENCE AREAS.
WE'RE NOT TRYING TO PRIORITIZE
ONE AREA OVER ANOTHER, IN THE
CASE OF NIAID, WE'LL BE LOOKING
AT STUDENTS THAT FIT THE MISSION
OR FOLLOW THE MISSION AREAS OF
NIAID AND I THINK THE NEED FOR
PHYSICIANS SCIENTISTS IS GREAT
ENOUGH AS WE WANT TO TAKE EVERY
OPPORTUNITY TO BE ABLE TO TRAIN
PEOPLE AND THIS CAREER PATH AS
WE CAN.
AND TO TROY TO PRE SELECT EARLY
BASED ON SOME PRIORITIZATION OF
AN INSTITUTES RESEARCH I THINK
IS NOT HELPING US GET PEOPLE IN
THE PIPELINE AS WE WOULD LIKE.
>> UNDERSTOOD.
THANK YOU.
>> GREAT.
THANK YOU.
THANK YOU Dr. FENTON.
LET ME REMIND, ASK PEOPLE TO
VOTE ON THIS CONCEPT PROPOSAL
AND PLEASE.
AND I KNOW THAT Dr.
DIEFFENBACH WOULD LIKE TO MAKE A
COUPLE OF ANNOUNCEMENTS BEFORE
WE CLOSE.
THANK YOU TO EVERYONE FOR THESE
REALLY FANTASTIC PRESENTATIONS
AND AS ALWAYS, A BREADTH OF
SCIENCE AND INTERESTING EXCITING
AND IMPORTANT CONCEPT AND
PROPOSALS.
SO THANK YOU TO EVERYONE FOR ALL
OF THEIR EFFORTS HERE.
>> THANK YOU.
I WANT TO ECHO YOUR COMMENTS
ABOUT THE BREADTH AND THE GREAT
THING ABOUT OUR SCIENCE, USING
THE COMMITTEE TO HELP
CROWDSOURCE, IT ONLY IS BETTER
THROUGH THE INPUT OF THE
COMMITTEE AND I APPRECIATE
EVERYBODY'S TIME ENERGY AND
THOUGHTFUL LESS AS THEY THINK
ABOUT THE CONCEPTS AND SCIENCE
REPORTING FORWARD.
SO, IT'S A TEAM EFFORT AND YOU
AS OUR ARAC ARE AN IMPORTANT
PART OF OUR TEAM.
SECOND, WE HAVE NO PUBLIC
COMMENTS TODAY AND WE DON'T HAVE
TO READ INTO THE RECORD.
AND LAST IS WE NEED AN ON BLOCK
ACTION BY SHOW OF HANDS OR SOME
SORT OF VOICE VOTE THAT THE
ENTIRE PROCEEDINGS HAS BEEN
ACCEPTED BY THE COMMITTEE.
SO, IF FOLLOWING ROBERTS RULES
OF ORDER LET'S HAVE A MOTION TO
APPROVAL OF TODAY'S ACTIVITIES.
>> I WILL MAKE A MOTION TO
APPROVE TODAY'S ACTIVITIES, IF I
CAN.
>> AND I GUESS WE'LL NEED A
SECOND.
>> SECOND.
>> AND THEN LET'S HAVE TH AYE AD
THE NAYs.
HEARING NONE, WE HAVE OUR BLOCK
APPROVAL AND I APPRECIATE
EVERYBODY'S TIME AND ENERGY AND
EFFORT TODAY.
AND THANK YOU ALL.
JUST QUICK REMINDER, JANUARY
WE'RE NOT IN BETHESDA SO IF YOU
SHOW UP THERE AND YOU DON'T WORK
THERE, YOU WILL HAVE TRAVELED
REALLY UNNECESSARILY BUT ALWAYS
FUN TO TRAVEL IN JANUARY.
>> IT'S SO MUCH FUN.
>> YES.
>> THANK YOU, EVERYONE!