SO THANK YOU AND WELCOME TO
THE OPEN DIVISION OF THE
DIVISION OF MICROBIOLOGY AND
INFECTIOUS DISEASE SUBCOMMITTEE
COUNCIL.
THE AGENDA FOR THIS AFTERNOON IS
ON THIS SLIDE.
I'M GOING TO GIVE A BRIEF REPORT
WITH A PERSONNEL UPDATE AS WELL
AS A FEW HIGHLIGHTS OF OUR
RESEARCH NEWS AND THINGS
ANNOUNCED SINCE WE LAST MET.
WE HAVE A NUMBER OF DMID
CONCEPTS FOR APPROVAL.
SIX OF THEM.
LAST WE HAVE A CONCEPT FROM ONE
OF OUR SISTER DIVISIONS THE
DIVISION OF CLINICAL RESEARCH.
WE HAVE A PRESENTATION ON THE
CONTRACT CONCEPT FOR THAT
DIVISION.
SO, FIRST I WANTED TO INTRODUCE
SOME NEW STAFF.
I'LL INTRODUCE THEM VIRTUALLY AT
LEAST.
DR. GENEVIEVE HOLZAPEL IN THE
VIROLOGY BRANCH AND A NEW
PROGRAM OF COOPERATIVE
AGREEMENTS THAT WILL FOCUS ON
VIRAL FAMILIES THAT HAVE
PANDEMIC POTENTIAL ON DEVELOPING
VACCINES AND MONOCLONAL
ANTIBODIES.
SHE CAME FROM GSK VACCINES
FOCUSSING ON PRE-CLINICAL
VACCINE DISCOVERY.
AND THEN ANNIE BRIDWELL FROM THE
VIROLOGY BRANCH WORKING ON THE
REVAMP PROGRAM AS WELL.
SHE WAS IN THE THERAPEUTIC
RESEARCH PROGRAM IN THE DIVISION
OF AIDS RESPONSIBLE FOR TB
FOCUSSED PORTFOLIO ON ANIMAL
MODELS AND PRE CLINICAL DIRECT
DEVELOPMENT.
SHUSHMA BHLOSE WILL OVERSEE THE
HEPATITIS PORTFOLIO.
SHE WAS AN ASSOCIATE STUDY
DIRECTOR AND LED THE DEVELOPMENT
OF MICROPHYSIOLOGIC SYSTEMS AT
THE HIGH CONTAINMENT LABORATORY
AT IRF.
SO THAT'S A BSL4 LAB IN
FREDERICK THAT COUNTER MEASURES
AGAINST HIGH-RISK VIRUSES.
AND FEORILLO GALIVO WAS A
PHARMACOLOGY AND TOXICOLOGY
REVIEWER AND TEAM LEAD AND WAS
FOCUSSED ON CELL AND GENE
THERAPY THERAPEUTICS FOR
ONCOLOGY AND NON-ONCOLOGY
INDICATIONS.
WELCOME TO THE VIROLOGY PROGRAM
OFFICERS.
WE ALSO WELCOME GEORGE JORGE
MEJIA-GALVIS.
HE'S HAD SEVERAL ROLES IN HIS
CAREER IN CLINICAL TRIAL WORK
AND DATA MANAGEMENT AND HE WAS A
MEDICAL MONITOR WORKING WITH ONE
OF OUR CONTRACTORS.
DR. YUNUS ABDUL COMES TO US FROM
THE ASPR IN ANOTHER HHS AGENCY
WHERE HE SUPPORTED
COMMERCIALIZATION OF COVID-19
ANTIVIRALS AND VACCINES
DEVELOPED IN OPERATION WARP
SPEED.
A LITTLE BIT OF RESEARCH NEWS
FROM PROGRAMS WE SUPPORTED.
THERE WAS AN ANNOUNCEMENT LAST
MONTH PUBLISHED IN THE JOURNAL
OF VACCINES THAT AN LASSA FEVER
VIRUS VACCINE PROTECTED NONHUMAN
PRIMATES FROM LETHAL DISEASE AND
IT'S BEEN PRIMARILY IN WEST
AFRICA IN THE BIOLOGIC THREAT
LIST AND THERE'S NO VACCINE
AVAILABLE BUT IS A HIGH PRIORITY
FOR PUBLIC HEALTH.
NON HUMAN PRIMATES WERE GIVEN
THIS IN A PROJECT AND WE WERE
PLEASED WITH THE SUCCESS OF THE
PROJECT.
YOU HEARD WE WERE FUNDING A
NUMBER OF NEW PROJECTS IN
SYPHILIS DIAGNOSTICS.
IF YOU HAVE DIAGNOSED PATIENTS
AND FOLLOWED THE DIAGNOSTICS ARE
TERRIBLE AND MORE THAN 50 YEARS
OLD AND HAVEN'T EVOLVED.
THE AWARD FOR NEW TECHNOLOGIES
THAT WILL LEAD TO BETTER
PROCESSING IN CLINICAL SAMPLES
SO THERE'S SMALL AMOUNTS OF
NUCLEIC ACIDS CAN BE DETECTS.
SOME FOCUS ON SPECIFIC
SUBCLASSES OF ANTIBODIES THAT
MAY BE GOOD DIAGNOSTIC TESTS.
SOME FOCUS ON A GENERAL OMICS
APPROACH HOSTING THE
REPRESENTATION.
SOME FOCUS ON CONGENITAL FOCUS
AND WE'RE HOPEFUL IT WILL MOVE
FORWARD WITH THE NEW PORTFOLIO.
THEN ANOTHER RECENT CLINICAL
TRIAL LAUNCHED YOU MIGHT RECALL
OVER THE PAST 10 YEARS AT LEAST
STARTING IN 2014 AND WHY EVERY
OTHER YEAR NEW OUTBREAKS OF
ACUTE FLACCID MYELITIS CASES
USUALLY YOUNG CHILDREN, TODDLERS
PRESENTING WITH PARALYSIS, ONE
ARM OR ONE LEG OR MORE THAN THAT
WITH SOME DOUBT THE PARALYSIS
INVOLVED UPPER MOTOR NEURONS OR
THE CRANIAL NERVES WHICH WAS
ALSO A FEATURE IN SOME CASES.
SO THIS WAS OBVIOUSLY A TERRIBLE
PROBLEM FOR THESE YOUNG PEOPLE.
WE STARTED TO WORK ON POTENTIAL
COUNTER MEASURES FOR THIS FOR
EBD6A THE AGENT CAUSING THE
PARALYSIS.
-- EV-D68 AND WE WERE ABLE TO
DEVELOP A MONOCLONAL ANTIBODY
AND A PROCESS TO CREATE IT IN
GENETICALLY MODIFIED PLANT AND
MAKE SUFFICIENT ANTIBODY THAT
COULD BE USED IN CLINICAL
TRIALS.
THEY STARTED IN THE PAST FEW
MONTHS AT VANDERBILT.
SOME HOPING SOME MUSCLE FUNCTION
CAN BE RESTORED IN THE CASE OF
THE ANIMAL OF THE EXPERIMENTS IN
THE LAB GET THE MONOCLONAL
ANTIBODY INJECTED EVEN AFTER
THEY'VE BEEN PARALYZED A SHORT
PERIOD OF TIME.
THE BELIEF OR HOPE IS THAT SOME
DAY THIS COULD BE AN EFFECTIVE
COUNTER MACHINE USED CLINICALLY.
THE FIRST STEP IS TO DO A
CLINICAL TRIAL THAT SHOWS IT'S
PK AND PD DISTRIBUTION AND
SAFETY IN ADULTS.
YOU'LL NOTICE THIS WAS A BIG
PROBLEM UP UNTIL 2018 AND THEN
WITH THE PANDEMIC THE CASES WENT
DOWN DRAMATICALLY.
YOU DEVELOP THIS AND THEN IT
GOES AWAY BUT WE HAVE A TRIAL IN
CASE THE OUTBREAKS RECUR.
AND WE'LL HAVE AMIR ZEITUNI TO
PRESENT.
THIS
>> THANK YOU FOR ALLOWING ME TO
PRESENT THE BROAD SPECTRUM
PRODUCTS AGAINST MULTIPLE
NEUROT
NEUROTOXIC BOTULINUM.
THE OBJECTIVE IS THE MEASURES
FOR BOTULINUM AND WHAT CAN
REVERSE THE BOTULINUM
INTOXICATION.
THE AGENTS WOULD COULD INCLUDING
BIOLOGICS FOR DRUGS.
WE'RE PROPOSING A BIPHASIC
MECHANISMS TO ALLOW UP TO SIX
R61 RESEARCH PROJECTS AND THEN
THOSE WILL BE DOWN SELECTED WITH
AGREED UPON MILESTONES R33
PROJECTS.
THE TOTAL COST FOR THE
INITIATIVE IS ANTICIPATED TO BE
$2.9 MILLION EACH YEAR FOR FIVE
YEARS.
FOR THE REST OF THE TALK I'M
REFERRING TO THE PHASE OF THE
AWARD.
BUT ALL OF THESE ARE PRE
CLINICAL IN NATURE.
SO NO HUMAN CLINICAL TRIALS WILL
BE SUPPORTED UNDER THE
INITIATIVE.
CLOSTRIDIUM BOTULINUM NEUROTOXIN
ARE BIO THREATS AND EASY TO GROW
AND MAKE THE MOST POTENT TOXINS
KNOW.
THERE'S SEVEN ESTABLISHED
SEROTYPESA-G.
IT CAN CAUSE FLACCID PARALYSIS
AND AND SYMPTOMS START 6 TO 36
HOURS AFTER EXPOSURE AND THE
PRAL LIST PROGRESSES TO THE
EXTREMITIES AND PARALYSIS TO THE
RESPIRATORY SYSTEM.
THERE'S A 5-10% WHEN PATIENTS
ARE TREATED WITH MEASURES IN A
GARDEN VARIETY EVENT USUALLY
INGESTION.
HOWEVER, IN AN INTENTIONAL
RELEASE THIS MORTALITY RATE IS
PROJECTED TO BE MUCH HIGHER.
THE CURRENT COUNTER MEASURES ARE
MECHANICAL VENTILATION AND THESE
ARE STORED IN THE STRATEGIC
NATIONAL STOCKPILE AND
DISSEMINATED BY CDC.
THEY'RE SPREAD AROUND THE UNITED
STATES AND SO IF ANTI-TOXIN IS
NEED FOR A PATIENT WITH
SUSPECTED BOTULISM IT CAN BE
PROVIDED TO A HOSPITAL ANYWHERE
WHEREIN THE UNITED STATES.
SO A LITTLE BIT MORE ABOUT THE
COUNTER MEASURES THAT ARE
CURRENTLY AVAILABLE.
THE MAIN COUNTER MEASURES TO
TREAT IN THE UNITED STATES ARE
BAT, WHICH IS EQUINE PEPTO VEIL
ENT AND IT'S A MONOCLONAL BASED
ANTITOXIN WITH PROTECTION
AGAINST THE TYPES A AND B.
BAT AND BABY BIG ARE BOTH IV
ADMINISTERED THEY MUST BE GIVEN
WITH 6 TO 48 HOURS AND THIS
TIGHT WINDOW NECESSITATES
TREATMENT BASED ON CLINICAL
SYMPTOMS.
FURTHER, LAB CONFIRMATION TAKES
ABOUT FIVE DAYS SO WAIT BEING
FOR LAB CONFIRMATION WOULD PLACE
A PATIENT BEYOND THE TREATMENT
WINDOW FOR BAT AND BABY BIG WHY
WE NEED A HEPTO VALENT TREATMENT
AND IT NECESSITATES SOMEONE
STAYING NEAR THE PATIENT WHO
RECEIVE THE IV INFUSION TO
MONITOR THE INFUSIONS.
THIS POTENTIALLY LIMITS THE
FUTILITY IN A MASS EXPOSURE
EVENT.
FINALLY, THOUGH THERE'S BATCH IT
BATCH VARIATION.
THERE'S NO COUNTER MEASURES
AVAILABLE TO REVERSE
INTOXICATION.
PATIENTS EXPERIENCING BOTULINUM
AND MUSCLE TOXINS WILL NEED
SUPPORT WITH VENTILATORS AND
FEEDING TUBES UNTIL THE NEURONS
REGROW.
THIS PROCESS CAN TAKE WEEKS OR
MONTHS AND COULD STRESS A
HOSPITAL'S ICU.
AFTERWARDS, PATIENTS WHO DO
SURVIVE BOTULISM MAY HAVE
FATIGUE AND SHORTNESS OF BREATH
FOR YEARS AND MAY NEED THERAPY
TO HELP THEM FULLY RECOVER.
THREES A CRITICAL NEED FOR THE
COUNTER MEASURES.
THESE COUNTER MEASURES WOULD
POTENTIALLY WORK BY EITHER
NEUTRALIZING CIRCULATING TOXIN
OR DEGRADING TOXIN ONCE IT'S IN
THE NEURON.
THIS INITIATIVE SEEKS TO PROMOTE
THE DEVELOPMENT OF ANTITOXINS
THAT REVERSE INTOXICATION WHICH
IS SOMETHING THAT THE CURRENT
COUNTER MEASURES CANNOT DO.
NOVEL THERAPEUTICS THAT CAN
REVERSE NEURONAL INTOXICATION
WOULD EXTEND THE THERAPEUTIC
WINDOW AND GET PEOPLE OUT OF
ICU.
WE HAVE THE TROJAN HORSE
CONCEPT.
AN EXAMPLE IS SHOWN HERE IT'S A
CHIMERIC FUSION PROTEIN THAT
USES THE BOTULISM TO TARGET THE
NEURON AND THEN IT WILL DEVELOP
THE THERAPEUTIC PAY LOAD
INTERNEURONALLY AND THERE'S
MULTI-VALENT ANTIBODIES THAT
TARGET SEROTYPES AND MOLECULES
AND ENGINEERED NANO BODY
PRODUCTS.
THE INITIATIVE WOULD PROMOTE THE
DEVELOPMENT AND REFINEMENT OF
THERAPEUTIC AGENTS THAT ARE
PLATFORM AGNOSTIC.
AND THE RECENT ADVANCES IN
TECHNOLOGY HAVE LAID THE
FOUNDATIONAL WORK FOR THIS
PROPOSED INITIATIVE.
FINALLY, BARDA HAS SIGNALLED
THEY'RE INTERESTED IN ADVANCING
THE DEVELOPMENT AND POTENTIAL
LICENSING OF NOVEL THERAPEUTICS
FOR BOTULISM.
HOWEVER, IT'S NIAID'S MANDATE TO
DEVELOP THE NOVEL THERAPEUTICS
BARDA WOULD BE PROCURING.
AS I INDICATED EARLIER, THIS IS
A BIPHASIC AWARD.
BEFORE THE AWARD IS MADE,
MILESTONES THAT ARE ALL
PEER-REVIEWED WILL BE
RENEGOTIATED AND WE ANTICIPATE
THE R61 PHASE OF ACTIVITIES WILL
BE MORE IN THE PROOF OF CONCEPT
SCREENING AND IDENTIFICATION OF
NEW THERAPEUTIC AGENTS,
SYNTHESIZING AND PURIFYING DRUGS
AND INHIBITORS AND LEAD
CANDIDATE DOWN SELECTION REALM.
AFTER TWO YEARS IN THE R61
PHASE, APPLICATIONS THAT HAVE
ACHIEVED THEIR TRANSITION
MILESTONES AND FOLLOWING
PROGRAMS INVOLVEMENT AND
APPROVAL, COULD POTENTIALLY
TRANSITION TO AN R33 PHASE.
IT'S ANTICIPATED THE R31 PHASE
WOULD BE MORE ADVANCED
DEVELOPMENT ACTIVITIES.
THESE WOULD INCLUDE PRE CLINICAL
SAFETY AND EFFICACY STUDIES,
PKPD AND PROCESS DEVELOPMENT FOR
MANUFACTURE AND ULTIMATELY CMPG
MANUFACTURE OF LEAD CANDIDATES.
APPLICATIONS WILL ADDRESS A
THERAPEUTIC NEED SPECIFIC TO
BONT SUCH AS BUT NOT LIMITED TO
BOTULINUM AGENTS, THERAPEUTICS
THAT RESTORE MOTOR AND NEURON
ACTIVITY FOLLOWING BOTULISM AND
DELIVER MRRMZ.
-- PLATFORMS.
I'VE HAD A CHANCE TO DISCUSS
THIS WITH DOCTORS TAYLOR AND
BOTUSTEAD AND AGREE IT'S
SOMETHING THAT IS NEEDED FOR
PREPAREDNESS.
WITH THAT I'M HAPPY TO TAKE ANY
QUESTIONS.
6:
>> COMMENTS OR QUESTIONS FROM
COUNCIL MEMBERS?
HEARING NONE, THANK YOU, AMIR.
>> THANK YOU.
THANK YOU ALL FOR YOUR TIME.
THE COUNCILS WILL NEED TO RECORD
THEIR VOTES IN THE ELECTRIC
COUNCIL BOOK.
YOU CAN DO IT IN THE END SINCE
WE DON'T HAVE A DROP DEAD TIME
THIS AFTERNOON.
SO OUR NEXT PRESENTER IS THERE
KAITLYN MORABITO FROM THE
VIROLOGY BRANCH.
>> TODAY, I'M GOING TO TALK
ABOUT OUR RENEWAL CONCEPT
RATIONAL DESIGN OF VACCINES
AGAINST HEPATITIS C VIRUS.
THIS IS A RENEWAL AND TO
OPTIMIZE BROADLY PROTECTIVE
VACCINES FOR HCV AND
SATISFACTION PROTECTION FOR
CANDIDATE AGENTS AND
METHODOLOGIES AND ENABLING
STUDIES TO ENABLE MOVING THESE
VACCINE CANDIDATES TOWARDS THE
CLINIC.
IT IS A RENEWAL.
WE'LL USE A U-19 MECHANISM.
WE'RE ANTICIPATING TWO TO FOUR
AWARDS AND FIRST YEAR OF $8.3
MILLION IN COST.
FIRST ON HEPATITIS C.
OR HCV IS A BLOODBORNE VIRUS AND
THE ACUTE INFECTION IS LARGELY
ASYSTEMATIC OR SOMETIMES MILD
SYSTEMS.
ONLY A SMALL FRACTION OF PEOPLE
CLEAR THIS 10% TO 30% AND THE
REST GO ON TO CLEAR CHRONIC
HEPATITIS OF A THIRD GO ON TO
HAVE CIRRHOSIS AND CAN LEAD TO
CANCER AND END STAGE LIVER
DISEASE.
IT'S PREVALENT AROUND THE WORLD.
THE W.H.O. HAS GOALS OF
ELIMINATING AND IT INCLUDES
PREVENTION OF HCV INFECTIONS AND
INCLUDE RESEARCH OBJECTIVES.
DESPITE THE FOCUS IN
ELIMINATION.
HCV HAS CONTINUED TO GROW.
IT CORRESPONDS WITH GROWING
OPIOID EPIDEMIC AND THERE'S BEEN
ABOUT 125% INCREASE IN NEW HCV
INFECTIONS IN THE UNITED STATES.
THERE'S SOME HOPE IT TAILED OFF
OR FLATTENED OUT IN THE PAST FEW
YEARS BUT STILL WELL ABOVE THE
STRATEGIC PLAN ANNUAL TARGET.
THE ANTIVIRALS STOP CHRONIC
INFECTION BUT STILL SUSCEPTIBLE
TO RE-INFECTION.
A POINT OF CARE DIAGNOSTIC WAS
MADE AVAILABLE BUT THERE'S NO
ROUTINE SCREENING SO A VACCINE
IS NEEDED TO PREVENT ACUTE AND
CHRONIC INFECTION AND HOPEFULLY
LIMIT TRANSMISSION AS WELL.
HCV VACCINE HAS ENCOUNTERED
NUMEROUS CHALLENGES.
AS MENTIONED BEFORE, ACUTE
INFECTION CAN GO ON TO BE
RESOLVED OR CHRONIC.
AND EVEN THOSE WHO RESOLVE ACUTE
INFECTION CAN GO ON TO BE
RE-INFECTED.
THIS HAS MADE IT DIFFICULT TO
TEASE OUT WHAT IT LOOKS LIKE.
IT'S HIGHLY DIVERSE.
THERE'S PREDOMINANTLY SIX
GENOTYPES THAT CIRCULATE.
GENOTYPE 1 AND 3 ARE MOST
PROMINENT WORLD WIDE IN THE
UNITED STATES AND OTHERS ARE
PROMINENT IN OTHER AREAS.
AND IT'S DIFFICULT TO GROW AND
CULTURE AND DOESN'T REPLICATE
THE MOST AVAILABLE ANIMAL
MODELS.
THERE'S NO ANIMAL MODELS EASILY
AVAILABLE TO EVALUATE EFFICACY
AND NO STANDARDIZED REAGENTS OR
ASSAYS.
SO ALL TOGETHER IT'S LED TO A
LACK OF DEFINED CORRELATES OF
DETECTION AND FEW HCV VACCINES
HAVE BEEN TESTED IN PHASE I AND
II CLINICAL TRIALS.
WE STARTED THE RATIONAL DESIGN
OF VACCINES AGAINST HEPATITIS C
VIRUS.
THE OBJECTIVES TO LOOK AT BROAD
IMMUNOLOGICAL PROTECTION AND
ELUCIDATE PROTECTION FROM
SAMPLES FROM COHORTS AND VACCINE
STUDIES AND CONSTRUCTING
VACCINES AND EVALUATING THEIR
IMMUNOGENICITY AND DEVELOPING
NEW ANIMAL MODELS.
WE AWARDED THREE U-19 AWARDS.
THEY'RE CURRENTLY IN THEIR
FOURTH YEAR AND HAVE BEEN HIGHLY
PRODUCTIVE WITH 27 PUBLICATIONS
SINCE THE START.
I'LL HIGHLIGHT A FEW
ACCOMPLISHMENTS THAT SHAPED WHAT
WE'RE THINKING FOR THE RENEWAL
OF THIS THE E1 AND E2
GLYCOPROTEIN THEY'VE DONE
EPITOPE MATCHING AND WE KNOW
ABOUT THE IMMUNE GENICITY OF THE
VARIETY.
AND LOOKED AT THE STRUCTURAL
ANALYSIS AND GENETIC ANALYSIS.
SO WE KNOW WHAT TYPES OF
ANTIBODIES ARE PROTECTIVE.
THEY'VE DONE SOME WORK TO LOOK
AT DIFFERENTIAL RESPONSES TO
PRIMARY INFECTION VERSUS
SECONDARY INFECTION VERSUS
VACCINATION AND UNDERSTANDING
MORE IN THE IMMUNE AND ADAPTIVE
IMMUNE RESPONSES.
AND WORK HAS BEEN DONE TO
UNDERSTAND AS I MENTIONED BEFORE
CHRONIC INFECTION AND THEN
THERE'S THERE IS RE-INFECTION
THAT OCCURS.
HOW VIREMIA RELATE TO DEPTH AND
POTENCY FROM SERUM.
THEY'VE ALSO BEEN ABLE TO
GENERATE A NUMBER OF VACCINE
CANDIDATES USING DIVERSE
APPROACHES.
SINCE THE CORRELATES HAVE NOT
BEEN DEFINED.
IT'S NOT CLEAR IF WE NEED B CELL
OR T CELL RESPONSES OR BOTH AND
STRATEGIES THAT FOCUS ON B CELL
RESPONSES AND THE E1, E2
HETERODIMER AND ANTIGENS AND
THOSE THAT USED ANCESTRAL
SEQUENCE.
THERE'S BEEN A NUMBER OF
PLATFORMS ON THE CONTINUUM OF B
CELL TO T CELL RESPONSES.
THE RATIONALE DESIGN AGAINST
HCV1.0 HAS HAD AN EXPANSION OF
FOUNDATIONAL KNOWLEDGE AND THE
GOAL IS TO TAKE THAT EXPANSION
OF FOUNDATIONAL KNOWLEDGE AND
HARNESS IT TO MOVE SOME OF THE
CANDIDATES TOWARDS THE CLINIC.
TO THE AIM THE RENEWAL WILL HAVE
CONTINUING OBJECTIVES.
WE THINK THERE'S MORE TO
UNDERSTAND IN STRUCTURAL AND
IMMUNOLOGICAL BASIS AND USING
THE VACCINE STUDIES HAVE BEEN
IMPORTANT FOR UNDERSTANDING THE
IMMUNE RESPONSE.
THAT WILL CONTINUE TO BE AN
OBJECTIVE.
AND AS WELL AS THE DESIGN AND
EVALUATION OF NOVEL ANTIBODY AND
TX VACCINE APPROACHES.
THE ADDITIONAL FOCUS IS HERE
WILL BE IN THE OPTIMIZATION AND
DOWN SELECTION OF VACCINE
CANDIDATES BASED ON IMMUNOGE
IMMUNOGENICITY AND TRANSFORMING
TO EVALUATION.
I THANK THOSE FOR HELPFUL
CONVERSATIONS.
A FEW THINGS THAT CAME UP THAT
VACCINES ARE ADDRESSED IN THE
W.H.O. HEPATITIS ELIMINATION
PLAN AND STRATEGIC PLAN.
ONE OF THE OTHER THINGS THAT IS
DIFFERENT ABOUT 2.0 IS WE
DECOUPLED ANIMAL MODEL
DEVELOPMENT FROM THE VACCINE
DEVELOPMENT AND I WANTED TO
HIGHLIGHT WE HAD ANOTHER
INITIATIVE THAT WAS RECENTLY
AWARDED TO LOOK SPECIFICALLY AT
ANIMAL MODELS FOR HEPATITIS B
AND C.
IN THE CONCEPT WE'LL LOOK FOR
DOWN SELECTION OF VACCINE
CANDIDATES BASED ON TARGETED
IMMUNE RESPONSE.
WE TALKED ABOUT POTENTIAL
POPULATIONS AND GENOTYPES.
WE HAVEN'T SPECIFIED IN THE CALL
WHAT THE TARGET POPULATION OR
WHAT GENOTYPE WOULD BE TARGETED
BUT WOULD NEED TO BE LOOKED INTO
FOR THE INVESTIGATORS.
AND I'LL BE HAPPY TO TAKE ANY
QUESTIONS.
>> THANK YOU, KAITLYN.
ANY QUESTIONS FROM COUNCIL
MEMBERS OR ANY ADDITIONAL
COMMENTS?
>> I HAVE A QUESTION RELATED TO
THE GENOTYPES WHAT IS KNOWN
ABOUT THE DIFFERENCE BETWEEN HOW
THE GENOTYPES DIFFER?
ARE THEY SIMILAR OR DIFFERENT OR
IS THAT KNOWN YET?
>> THERE'S SOME SIMILARITIES AN
DIFFERENCES AND GENOTYPE DOESN'T
PREDICT WHETHER AN ANTIBODY
WOULD NEUTRALIZE OR NOT SO IT'S
COMPLICATED.
>> THE GOAL IS EVEN IF IT
FOCUSSED ON A SINGLE GENOTYPE
THAT WOULD BE INTERESTED TO BE
QUITE AN ADVANCE?
GOODNIGHT
GENOTYPE 1 AND 3 ARE MOST
COMMON.
>> ANY ADDITIONAL QUESTIONS?
THANK YOU, KAITLYN.
OUR NEXT FISCAL YEAR '26 CONCEPT
WILL BE PRESENTED BY THAMES
PICKETT FROM OBRRTR.
THERE WE GO.
>> GOOD AFTERNOON, EVERYONE.
I'M THAMES PICKETT.
I'M PRESENTING THE IN VITRO
ASSESSMENTS OF ANTIMICROBIAL
ACTIVITY CONCEPT.
THE OBJECTIVES ARE TO SCREEN --
>> CAN YOU GET CLOSER TO THE
MICROPHONE?
>> SURE.
THE OBJECTIVES ARE TO SCREEN
THERAPEUTIC CANDIDATES MAINLY
FOR EXTERNAL REQUESTERS, PRODUCT
SPONSORS AND CHEMICAL COLLECTION
OF INTEREST AND WELL
CHARACTERIZED TRAVEL MATERIAL
FOR PATHOGENS AND PRODUCE
DEVELOP METHODS FOR GROWING
DIFFICULT TO CULTURE ORGANISMS.
THIS IS A RENEWAL OF INDEFINITE
QUANT OR IDIQ CONTRACT OF THE
SAME NAME AND WE PLAN TO AWARD
BETWEEN 15 AND 25 BASE
CONTRACTS.
TO SUPPORT ITS MISSION, DMID
PROVIDES A BROADBAND SUITE OF
PRE CLINICAL SERVICES WHICH I
MAY REFER TO AS PCS GOING
FORWARD.
THE SERVICES FACILITATE BASIC
RESEARCH THROUGH ALL PHASES OF
DEVELOPMENT AND INTENDED TO BE
GAP FILLING.
THERE'S NO PREREQUISITE TO HAVE
NIH FUNDING AND THE SERVICES ARE
FREE OF CHARGE.
THE OUTPUT IS PRIMARILY PRODUCT
SPECIFIC DATA GENERATED BY THE
CONTRACTORS AND PROVIDED TO THE
PRODUCT SPONSORS.
IVAAA IS A CRITICAL COMPONENT OF
THE SUITE OF SERVICES
REPRESENTING THE EARLIEST PHASE
IN PRECLINICAL TESTING AND IS
OFTEN THE ENTRY POINT FOR FUTURE
TESTING DEVELOPMENT.
SO THIS GRAPHIC REPRESENTS THE
FACT THAT IN VITRO CONTRACTS
TEST A LARGE NUMBER OF PRODUCTS
TO IDENTIFY A SMALL NUMBER WITH
PROMISING ACTIVITY.
IN THIS CASE SINCE 2019 SINCE
THESE AWARDS WERE MADE FOR THE
CURRENT CONTRACT, MORE THAN
5,000 PRODUCTS HAVE BEEN TESTED
AND 120 PROGRESSED TO IN VIVO
TESTING THROUGH OTHER
PRE-CLINICAL SERVICES PROGRAMS.
THIS REPRESENTS 2.75%
PROGRESSION IN TO IN VIVO
TESTING.
IN SOME FORM THIS CONTRACT
PROGRAM HAS EXISTED SINCE 2003
TO PROVIDE IN VITRO SCREENING
SERVICES.
IN 2023, 10 CONTRACTS WERE
AWARDED THAT SUPPORTED IN VITRO
AND IN VIVO TESTING AND CALLED
AT THE TIME CATEGORY A THROUGH C
TESTING AND OF THE 10
CONTRACTORS FIVE WERE
RESPONSIBLE FOR PERFORMING THE
IN VITRO TESTING.
IN 2011, 14 CONTRACT AWARD WERE
MADE UNDER WHAT WAS NOW CALLED
THE IN VITRO ASSESSMENT OF AN
ANTIMICROBIAL ACTIVITY AND AT
THIS POINT IT WAS MOVED TO A
SEPARATE CONTRACT.
EACH ITERATION INCLUDING THE
CURRENT ONE THE BASE CONTRACTS
HAVE HAD A SEVEN YEAR ORDERING.
THE CURRENT IVAAA IDIQ CONTRACTS
WERE AWARDED IN 2019.
THE SCOPE WAS ALL PATHOGENS OF
INTEREST TO DMID.
14 CONTRACTS WERE AWARDED.
THE CONTRACTOR POOL IN TOTAL IS
14 CONTRACTORS.
WHEN THE RFP WAS ISSUED THE PLAN
WAS TO DIVIDE THE WORK INTO FIVE
TEST AREAS.
TESTING FOR ANTI-TOXINS,
ANTIVIRALS AND COUNTER MEASURES
AND TECHNOLOGIES AND DEVELOPIIN
METHOD FOR DIFFICULT TO GROW
PATHOGENS.
NO PROPOSALS WERE RECEIVED FOR
THE HOLLOW FIBER TECHNOLOGIES.
THAT'S WHY IT'S GRAYED OUT.
THE FINAL POOL HAD JUST FOUR
TASK AREAS AND THOSE ARE THE
SAME TASK AREAS THAT WILL BE
CARRIED FORWARD UNDER THE
CURRENT CONCEPT.
SOME WERE AWARDED UNDER A
SEPARATE IDIQ.
THAT TECHNOLOGY IS COVERED.
REQUESTS COME FROM ALL SECTORS
AND FROM MORE THAN 20 COUNTRIES.
OVER 50% OF REQUESTS ARE FROM
INDUSTRY AND THE VAST MAJORITY
ARE SMALL BUSINESSES AND
PRIVATELY HELD BUSINESSES.
MANY ARE START-UPS THAT RELY ON
THE DATA TO MOVE FORWARD WITH
THEIR IDEAS.
ABOUT 30% OF REQUESTS COME FROM
ACADEMIA AND THE REST ARE
DIVIDED AMONG OTHER GOVERNMENT
AGENCIES, NONPROFITS AND OTHERS.
ABOUT TWO-THIRDS OF TESTING
UNDER THIS PROGRAM IS ANTIVIRAL
TESTING.
THE VAST MAJORITY OF COUNTER
MEASURES TESTED,
HIGH-CONSEQUENCE PATHOGENS WE
HEARD ABOUT ALL DAY INCLUDING
VIRUSES HAVING PANDEMIC
POTENTIAL, BACTERIA AND FUNGI
LISTED IN THE CDC 2019
ANTIMICROBIAL THREAT REPORT AND
BACTERIA ON THE SELECT AGENT
LIST.
SO I HAVE DIVIDED FOR THE
PURPOSE OF THIS TALK, I'VE
DIVIDED THE EFFORTS TO SCREEN
ANTIBACTERIAL, ANTI-FUNGAL
PRODUCTS FOR THAT PERFORMED FOR
PRODUCT SPONSORS AND THAT WHICH
PERFORMED AS BROADER SCREENING
AB ACTIVITIES.
THERE'LL BE TESTING DEPICTED FOR
PRODUCT SPONSORS.
IT'S FOCUSSED ON AMR THREATS AND
TIER 1 SELECT AGENTS.
THE PREFERRED PRE REQUEST FOR
PRODUCT SPONSORS IS EVIDENCE OF
SOME IN VITRO ACTIVITY AGAINST A
RELEVANT SPECIES OF BACTERIA OR
FUNGI.
THE EXPECTATION IS ANY POSITIVE
DATA FROM THE TESTING ALONG WITH
IN VIVO DATA WILL BE USED TO
PROKUSE FURTHER FUNDING OR
INVESTMENTS SUPPORT FOR FURTHER
DEVELOPMENT.
AS NOTED HERE, 52 REQUESTERS
HAVE ASKED FOR ANTI-FUNGAL
TESTING AND 68 FOR ANTIBACTERIA
TESTING AND THE NUMBER THAT
MOVED TO IN VIVO TESTING
INTERCEPT QUITE AS HIGH.
SO IN TERMS OF ACHIEVEMENTS IN
THIS AREA, MORE THAN 10% OF THE
ANTIBACTERIAL AND ANTI-FUNGAL
PRODUCTS MOVED ON TO TESTING
UNDER THE PROGRAM.
IN VITRO DATA CAN HAVE SELECTION
OF A PRIMARY INDICATION AND DATA
HAVE BEEN USED DOWN THE LINE IN
REGULATORY SUBMISSIONS.
ONE INTERESTING ACHIEVEMENT IS
THAT EVERY CLINICAL STAGE
ANTIFUNGAL HAS BEEN TESTED
EXCEPT ONE THROUGH IN VIVO
CONTRACT IS.
I'VE LITTED A COUPLE
PUBLICATIONS DOCUMENTING THE
FOUNDATIONAL IMPACT OF THE
PROGRAM ON TWO OF THE DRUGS.
FINALLY, THIS TESTING HAS
SUPPORTED SEVERAL INVESTIGATORS
IN THE CARBX PROGRAM BEING A
GLOBAL NONPROFIT ACCELERATOR TO
ADDRESS ANTIMICROBIAL
RESISTANCE.
NIAID S IN-KIND SERVICES TO
SUPPORT INVESTIGATORS AND
CURRENTLY FIVE CARB-X PROGRAMS
GRADUATES HAVE BEEN SUPPORTED BY
THE PROGRAM.
AIN IN
IN ADDITION, THE CONTRACT HAS
PROVIDED MORE BROAD SCREENING OF
PROMISING CHEMICAL COLLECTIONS.
THE FIRST POINT IS IN A
COLLABORATION WITH NATIONAL
CANCER INSTITUTE A LARGE NATURAL
PRODUCT SCREEN WAS UNDERTAKEN
AGAINST A PANEL OF BACTERIAL AND
FUNGAL SPECIES.
AND IN THIS CASE 300,000
PARTIALLY PURIFIED PRODUCT
FRACTION TESTED.
OVER 3,000 IDENTIFIED AS HAVING
ANTI-FUNGAL ACTIVITY AND A
SUBSET OF THESE WERE PURIFIED
AND THEIR STRUCTURES ASSESSED
AND FOUND TO REPRESENT HAVING
ANTIMICROBIAL ACTIVITY THAT LAD
NOT BEEN PREVIOUSLY IDENTIFIED.
THE SECOND IS MIC SCREENING FOR
THE CHEMISTRY CENTER FOR
COMBATTING ANTIMOOISH YAL --
ANTIMICROBIAL MATTER IN DRUG
DISCOVERY.
IT'S PERFORMED A PANEL OF DRUG
RESIST TAPT AND WILD TYPE
STRAINS TO ALLOW THE PROVISION
OF A COMMON BASELINE FOR FURTHER
DEVELOPMENT.
ALL MIC RESULTS ARE ADDED TO THE
CC FOR CARB DATABASE AND
PROVIDED TO INVESTIGATORS TO
FACILITATE STRUCTURE ACTIVITY
RELATIONSHIP STUDIES AND EARLY
DEVELOPMENT.
SO MOVING ON TO ANTIVIRAL
SCREENING.
THE GOAL IS TO IDENTIFY PRODUCTS
EXHIBITING MAXIMAL VIRAL
INHIBITION WITH MINIMAL
TOXICITY.
THESE ARE ALL CELL-BASED ASSAYS.
THESE REPRESENT COST-EFFICIENCY
AS WELL AS QUICK TURN AROUND
WITH WHICH PARTICULARLY
IMPORTANT TO GETTING INFORMATION
BACK TO THE DEVELOPERS QUICKLY.
THE FOCUS AS I MENTIONED BEFORE,
MOST OF THE TESTING HAS BEEN
DONE AGAINST PANDEMIC VIRUSES
ALONG WITH OTHER VIRUSES BUT
PRIMARILY THE SEVEN FAMILIES
THAT HAVE BEEN IDENTIFIED AS
HAVING PANDEMIC POTENTIAL.
TESTING IS ORGANIZED INTO TIERS.
PRIMARILY TESTING BEING
CYTOPATHIC EFFECT AND SECOND IS
VIRAL YIELD PRODUCTION AND
TERTIARY IS TESTING FOR
ANTIBODY-BASED PRODUCTS AND
OTHER CHANGING CONDITIONS OF THE
CULTURE.
CY
CYTOTOXICITY FOR TESTING AND
INTO IN VIVO STUDIES.
SO IN TERMS OF THE VOLUME OF
THIS TESTING AS WELL AS AN
EXAMPLE OF SUCCESS FROM 2019 TO
2024 WERE REQUESTS FROM ALMOST
1,000 UNIQUE REQUESTERS.
MORE THAN 5,000 PRODUCTS HAVE
BEEN TESTED IN THIS TIME FRAME.
AS MENTIONED TESTING IS
ORGANIZED INTO TIERS.
AND IT'S REPRESENTED HERE
OBVIOUSLY MANY MORE PRIMATES
TESTED.
YOU CAN SEE A FEW CAN GRADUATE
TO SECONDARY TESTING.
76 ANTIVIRAL PRODUCTS MOVED ON
TO IN VIVO TESTING UNDER THE
OTHER PCS CONTRACTS.
IN 2015 AT THE MID POINT OF THE
LAST ITERATION OF THE CONTRACT
PROGRAM ALMOST THE EXACT NUMBER
OF PRODUCTS HAD BEEN TESTED AND
GONE TO IN VIVO STUDIES WHICH
REPRESENTS THE CONSISTENCY OF
THE PROGRAM.
THE CONSISTENCY AND DEMAND ON
THE PROGRAM.
SO ONE AND ONE IS CYCLOPROPAVIR
AND MESSED ON TO IN VIVO STUDIES
UNDER ANOTHER CONTRACT PROGRAM
AND WAS FOUND PROMISE BEING FOR
MULTIPLE INDICATIONS.
THIS SUCCESSFULLY COMPLETED
PHASE I TRIAL AND THERE'S PLANS
TO MOVE IT INTO A PHASE II TRIAL
FOR TRANSPLANT RECIPIENTS.
THIS IS NOT YET IN CLINICAL
TRIALS.gov BUT STATED GOAL OF
THE PRODUCT SPONSOR.
ANOTHER STATED GOAL IS TO PURSUE
CLINICAL DEVELOPMENT FOR
ADENOVIRUS IN HUMAN HERPES VIRUS
VI INDICATIONS.
IT'S A BROAD SPECTRUM.
I MUST MENTIONED THE IN VIVO
RESPONSE TO SARS COV2.
CONTRACTS OFFER FLEXIBILITY TO
PIVOT QUICKLY TO ADDRESS MENTAL
HEALTH EMERGENCIES LIKE THE
COVID PANDEMIC AND STARTING IN
2020 WAS ABLE TO RESPOND TO THE
DEMANDS OF THE PANDEMIC.
TO DATE 91 PRODUCTS WITH 46
REQUESTERS HAVE BEEN TESTED
SPECIFICALLY AGAINST SARS COV2.
OF THESE 21 MOVED ON TO TESTING
IN SMALL AN PLAL MODELS OF COVID
INFECTION.
I WANT TO THANK DOCTORS ESTES
AND PALMER REMARKING ON THE
SERVICE.
BOTH IMPRESSED BY THE BROAD
SCOPE OF PATHOGENS COVERED IF
THE CONTRACT.
THE LIBRARY AND CHEMICAL ENTITY
COLLECTION IS OF PARTICULAR
VALUE AND WORTHY OF INCREASED
MESSING.
BOTH DISCUSSED THE METRICS WE
USED TO DETERMINE THE SUCCESS OF
THE PROGRAM AND HOW WE DECIDED
TO MOVE FORWARD WITH TESTING A
PARTICULAR ENTITY.
THE SPONSORS WHO REQUEST
SERVICES AND THE TYPICAL AMOUNT
OF TIME NEEDED TO AWARD SCORERS.
AGAIN, THIS IS A RAPID TURN
AROUND SO THAT WAS OF INTEREST
AS WELL.
DR. PALMER NOTED THE FLEXIBILITY
AND RAPID RESPONSIVENESS ARE
ESSENTIAL ELEMENTS OF THE
PROGRAM FOR ADDRESSING PUBLIC
HEALTH EMERGENCIES AND PROVIDING
RESULTS FOR PRODUCT DEVELOPERS
ON IN TIME GO/NO-GO PERFORMANCE
AND WERE SUPPORTIVE EFFORTS AND
ACKNOWLEDGED THE DRUG
DEVELOPMENT IN THE AREA LAGS
BETWEEN ANTIBACTERIAL AND
ANTIBIOTIC DEVELOPMENT.
RETURNING TO THE CONCEPT SLIDE
I'M HAPPY TO ANSWER ANY
QUESTIONS.
>> ANY QUESTIONS OR COMMENTS?
VERY CLEAR AND COMPREHENSIVE
APPARENTLY.
SO WE'RE MOVING EFFICIENTLY THIS
AFTERNOON.
OUR NEXT CONCEPT WILL BE
PRESENTED BY MICHELLE ARNOLD
FROM THE RESPIRATORY DISEASE
BRANCH.
>> THANK YOU FOR THE OPPORTUNITY
TO PRESENT THIS INITIATIVE WHICH
IS TITLED THE IMPACT OF INITIAL
INFLUENZA EXPOSURE ON IMMUNITY
AND INFANTS.
THE OBJECTIVE IS TO DETERMINE
HOW INFLUENZA INFECTIONS OR
VACCINES SHAPES PROTECTIVE
IMMUNITY TO FUTURE EXPOSURES IN
LONGITUDINAL HUMAN INFANT
COHORTS.
THIS IS A RENEWAL INITIATIVE
FIRST ESTABLISHED IN 2008.
THERE ARE CURRENTLY TWO ACTIVE
AWARDS BUT THIS WILL BE AN OPEN
COMPETITION TO ALLOW RESEARCH
TEAMS TO PROPOSE NEW OR
CONTINUING SUPPORT OF EXISTING
INFLUENZA INFANT COHORTS.
AT LEAST TWO UL 1 COOPERATIVE
AGREEMENTS ARE EXPECTED IN
FISCAL 26 AND CO-MANAGED BETWEEN
THE DIVISION OF MICROBIOLOGY AND
INFECTIOUS DISEASES AND ALLERGY,
IMMUNOLOGY AND TRANSPLANTATION.
A CHILD'S FIRST EXPOSURE TO
INFLUENZA BY INFECTION OR
VACCINATION LEADS TO THE PRODUCT
OF ANTIBODIES AND MEMORY B CELLS
THAT RECOGNIZE ANTIGENIC
EPITOPINGSS -- EPITOPES AND TH
MEMORY B CELLS ARE ESSENTIAL TO
RESPONDING TO FUTURE INFECTIONS.
INFLUENZA VIRUSES MUTATE AND
CHANGE OVER TIME RESULTING IN
DIFFERENCES TO THE SURFACE
PROTEINS.
EXPOSURE TO A RELATED ANTIGEN
FROM A SECOND OR THIRD INFLUENZA
INFECTION LEADS TO A MIXED
PRIMARY AND RECALL IMPRINTED
IMMUNE RESPONSE.
THE PRIMARY RESPONSE TO THE NEW
ANTIGEN EXPOSURE IS LESS
EFFICIENT AND OVERWHELMED BY THE
RAPID AND ROBUST MEMORY B CELL
CALL RESPONSE TO THE ANTIGENS.
THUS THE IMPRINTED ANTIBODY
RESPONSE IS MORE ROBUST THAN THE
NEW ANTIGEN.
HUMANS REMAIN THE PATTERN OF
HEIGHTENED REACTIVITY AGAINST
INFLUENZA VIRUS CIRCULATED
DURING THE CHILDHOOD.
WHILE THE RESPONSE IS KNOWN TO
OCCUR FOR VIRUSES LIKE INFLUENZA
AND SARS COV2 COULD BE
APPLICABLE TO OTHER MUCOSAL
PATHOGENS.
AND TO THE FIRST EXPOSURE WORKS
WITH AND IS IMPRINTING CAN BE
HARNESSED TO MAKE VACCINES FOR
INDIVIDUALS OR DO THE EFFECTS
NEED TO HAVE MORE EFFECTIVE AND
DURABLE VACCINES FOR ADULTS.
UNDERSTANDING IMPRINTING IS THE
IMPORTANT OBJECTIVE OF THE
INFLUENZA STRATEGIC PLAN
SPECIFICALLY OBJECTIVE 2.1 WHICH
AIMS TO UNDERSTAND HOW AND WHEN
EXPOSURE TO INFLUENZA ANTIGENS
SHAPE THE HOST RESPONSE TO
INFLUENZA INFECTION AND
VACCINATION.
THE CURRENT AWARDS IN THE
PORTFOLIO ALSO CONTRIBUTE TO THE
CROSS-CUTTING TOOLS TO IMPROVE
INFLUENZA VACCINES BY
ESTABLISHING LONGITUDINAL
COHORTS FOR INFLUENZA RESEARCH.
APPLICATION TO THE FIRST NOTICE
OF FUNDING OPPORTUNITY WERE
REVIEWED AND RECEIVED IN 2018.
TWO COOPERATIVE AGREEMENTS WERE
AWARDED IN APRIL OF 2019.
THESE WERE SEVEN-YEAR AWARDS TO
ENABLE THE ESTABLISHMENT OF
COHORTS AND TO TIME TO PROVIDE
TWO OR MORE EXPOSURES TO
INFLUENZA EITHER BY VACCINATION
OR INFECTION.
THE UNANTICIPATED SARS COV2
PANDEMIC EARLY IN THE AWARD
RESULTS IN FEW INFLUENZA CASES
IN 2020 TO 2021 AS WELL AS THE
2021 TO 2022 SEASONS.
THE ABSENCE OF INFLUENZA
INFECTIONS INITIALLY AFFECTED
THE ENROLLMENT OF PARTICIPANTS
EXPOSED BUT WITH RESEARCH FROM
THE PROGRAMS CONTRIBUTED TO
UNDERSTANDING SARS COV2 EARLY IN
THE PANDEMIC AND THEY HAVE
RECRUITED MORE PARTICIPANTS THAN
PLANNED TO PARTICIPATE IN THE
ORIGINAL STUDY DESIGN.
THE CURRENT COOPERATIVE
AGREEMENT THE DA VINCI OR
DISSECTION OF THE IMMUNITY
AWARDED TO PAUL TOMS AT ST. JUDE
CHILDREN'S RESEARCH HOSPITAL AND
UNIVERSITY OF MICHIGAN.
THE SECOND STUDY IS THE IMPACT
OR IMPACT OF THE INITIAL
INFLUENZA EXPOSURE ON THE
QUALITY, MAGNITUDE, BREADTH,
POTENCY AND IMMUNITY AWARDED TO
MARY STAT AT CINCINNATI
CHILDREN'S HOSPITAL.
THE DA VINCI STUDY COHORT HAVE A
TOTAL ENROLLMENT OF
APPROXIMATELY 2100 CHILDREN
ACROSS THE COHORTS INCLUDING
NICARAGUA COVERING THE SOUTHERN
HEMISPHERE, NEW ZEALAND COVERING
A TROPICAL LOCATION AND SOUTHERN
CALIFORNIA WHICH COVERS THE
NORTHERN HEMISPHERE.
THIS ALLOWS FOR YEAR ROUND
SAMPLE COLLECTION AND COVERAGE
OF INFECTIONS AND VACCINATION
EXPOSURES.
THE SITE OF NICARAGUA HAS A
COHORT THAT BEGAN IN 2011 RAAND
HAS AN ACTIVE ENROLLMENT OF
1,248 WITH 181 PARTICIPANTS
CONFIRMED TO HAVE MORE THAN ONE
EXPOSURE TO INFLUENZA.
THE NEW ZEALAND SITE AN ACTIVE
ENROLLMENT OF 652 CHILDREN WITH
228 PARTICIPANTS CONFIRMED TO
HAVE MORE THAN ONE EXPOSURE.
AND THE SOUTHERN CLINICAL
RESEARCH SITE HAS AN ACTIVE
ENROLLMENT OF 230 WITH 125
CONFIRMED SECOND EXPOSURES IN
THE CASE ALL BY VACCINATION.
THE SITE IN MEXICO HAS AN
ENROLLMENT OF 790 AND THE SITE
IN CINCINNATI HAS 1,490
ENROLLEES.
THE INCLUSION OF MOTHER-CHILD
PAIRS ALLOWS FOR THE ADDITIONAL
CONSIDERATION OF MATERNALLY
TRANSFERRED ANTIBODY.
THE LARGE COHORTS ARE NECESSARY
TO COLLECT STATISTICALLY
SIGNIFICANT NUMBER OF SECOND AND
THIRD EXPOSURES IN ORDER TO
UNDERSTAND THE EFFECTS OF
IMPRINTING.
AND THERE MAY BE DIFFERENCES TO
DISCOVER DEPENDING ON WHETHER
THE FIRST AND SECOND EXPOSURES
WERE EITHER BY VACCINATION OR BY
INFECTION.
AS THE COHORTS ENROLL AND FOLLOW
PARTICIPANTS THEY'RE COLLECTING
SAMPLES AND IN DEPTH ANALYSIS OF
ANTIBODY B CELL AND T CELL
RESPONSES.
THESE CURRENTLY ARE UNDERWAY
WITH CONFIRMED CASES OF FIRST
AND SECOND EXPOSURES TO
INFLUENZA VIRUS.
THE COMPREHENSIVE PANEL OF
ASSAYS WILL OFFER A DETAIL LEVEL
OF CHARACTERIZATION AND PROVIDE
AN UNPRECEDENTED DEGREE OF
RESOLUTIONS.
THE OUTCOMES ARE ESSENTIAL FOR
DETERMINING THE IMPACT OF FIRST
EXPOSURE ON THE IMMUNE RESPONSES
ON THE CELLULAR AND ANTIBODY
RESPONSES TO SUBSEQUENT
EXPOSURES.
GIVEN THE COMPLEXITY OF THE
EXPOSURES, THESE FINDINGS ARE
LIKELY TO BE ITERATIVE AS THE
ANALYSES EXPAND WITH THE
INCREASING NUMBER OF SAMPLES
BEING EVALUATED.
RESEARCH FROM THE DA VINCI STUDY
CONTRIBUTED TO 70 PUBLICATIONS
INCLUDING HIGH IMPACT
PUBLICATIONS ON THE NICARAGUAN
COHORTS PUBLISHED IN CLINICAL,
INFECTIOUS DISEASES AND
CORRELATES INDEPENDENT OF
SEROLOGY AND IMMUNOLOGY AND
BASAL STATE AND IMPLICATIONS FOR
DISEASE.
RESEARCH FROM THE IMPRINT STUDY
CONTRIBUTED TO 11 PUBLICATIONS
INCLUDING MULTI-OMICS ANALYSIS
OF MUCOSAL AND SYSTEMIC IMMUNITY
OF SARS COV2 AFTER BIRTH IN THE
CELL AND A STUDY OF THE FACTORS
WITH PROLONGED VIRUS PROTECTION
WITH PCR OF NASAL SPECIMENS
COLLECTED LONGITUDINALLY IN
HEALTHY CHILDREN IN A
U.S. COHORT IN THE JOURNAL OF
THE PEDIATRIC INFECTIOUS
DISEASES SOCIETY.
THE RENEWAL OF THIS INITIATIVE
NOW PROPOSES FIVE-YEAR AWARDS
WHICH ARE EXPECTED TO SUPPORT
THE ESTABLISHMENT OR
CONTINUATION OF INFANT COHORTS
TO DETERMINE HOW INITIAL NATURAL
INFLUENZA EXPOSURE OR
VACCINATION SHAPES IMMUNE
REASONS TO SUBSEQUENT EXPOSURES.
PROSPECTIVE COHORTS WILL BE
FOLLOWED PRIOR TO AND AFTER
RECEIVING THE INITIAL INFLUENZA
VACCINATIONS OR AFTER THE
CLINICAL DIAGNOSIS OF INFLUENZA
INFECTION PRIOR TO RECEIVING AN
INITIAL INFLUENZA VACCINATION.
RESEARCH PLANS ARE EXPECTED TO
ADDRESS THE EFFECTS OF REPEATED
EXPOSURES TO INFECTIONS OR
VACCINATIONS ON THE MAINTENANCE
ON IMMUNITY IN INFANTS AND
CHILDREN AND LOOK AT VACCINATION
VERSUS NATURAL INFECTION AND
TAKE OTHER VACCINATIONS INTO
CONSIDERATION BUT STILL MEASURE
RESPONSE TO INFLUENZA.
I WOULD LIKE TO THANK THE
COUNCIL MEMBERS WHO REVIEWED
THIS FOR THEIR TIME AND
COMMENTS.
AND NOTED RESEARCH PROGRAMS TO
UNDERSTAND EARLY IMMUNE
RESPONSES IN KNEEE JONIOO --
SUPPORTED SUPPORT FOR COHORT
STUDIES PROVIDES FOUNDATIONAL
INFORMATION TO IMPROVE IMMUNE
HEALTH AND VACCINE EFFICACY.
I APPRECIATE THE SUPPORT ON THE
AND I CAN TAKE ANY QUESTIONS.
>> ANY QUESTIONS OR ADDITIONAL
COMMENTS?
>> I'LL COMMENT.
I THINK IT'S AMAZING FOR ALL THE
YEARS WE'VE STUDIED INFLUENZA
AND ALL THE RESEARCH THAT'S BEEN
DONE WE STILL DON'T REALLY
UNDERSTAND WHAT HAPPENS WITH
IMPRINTING FROM THE FIRST
INFECTION AND VACCINATION.
I THINK IT'S A VERY IMPORTANT
STUDY.
>> MOVING ON TO THE NEXT
CONCEPT, MICHAEL ISON FROM THE
RESPIRATORY DISEASE BRANCHING.
-- BRANCH..
-- BRANCH.
>> IT'S MY HONOR TO TALK ABOUT
THE COLLABORATIVE INFLUENZA
VACCINE INNOVATION CENTER THE
CIVICS PROGRAM IS TO ADVANCE
IMPROVEMENTS ON SEASONAL VACCINE
AS WELL AS ACHIEVE OUR LONG-TERM
GOAL OF UNIVERSAL INFLUENZA
VACCINE.
MOVE THEM THROUGH MANUFACTURING
AND INTO THE CLINIC AND TAKE THE
DATA THAT IS GENERATED FROM THAT
PROGRAM BACK TO THE LAB TO
ITERATIVELY IMPROVE THE VACCINE.
WE'RE ANTICIPATING FIVE TO SIX
AWARDS FOR VACCINE DEVELOPMENT
AND DEVELOPMENT CENTERS.
AIL TALK THROUGH BACKGROUND AND
THE CURRENT PROGRAMS HERE OVER
THE NEXT MINUTE OR SO.
AS WE'RE SEEING MORE AND MORE
CASES OF H5N1 IN HUMANS AND
CASES IN ANIMALS, THERE'S A NED
FOR BROADLY PROTECTIVE INFLUENZA
VACCINE TO HELP US BE BETTER
PREPARED FOR FUTURE PANDEMICS.
INFLUENZA STILL CAUTIONS
SIGNIFICANT MORBIDITY AND
MORTALITY AND WHILE WE HAD A
LITTLE REPRIEVE DURING THE COVID
PANDEMIC IT'S ROARED BACK TO
PRE-PANDEMIC LEVELS.
ABOUT 18 TO 35 MILLION ILLNESSES
AND 16 MILLION MEDICAL VISITS
AND UP TO 440,000 HOSPITALIZINGS
AND UP TO 38,000 DEATHS.
WE HAVE VACCINATIONS AVAILABLE
BUT IT UP TAKE FLUCTUATES.
BACK IN 2018 NIAID OUTLINED THE
UNIVERSAL INFLUENZA VACCINE
STRATEGY HOPING TO DEVELOP A
UNIVERSAL FLU VACCINE 75%
EFFECTIVE IN PROTECTING ILLNESS
AND PROTECTING AGAINST GROUP 1
AND 2 AND DURABLE PROTECTION
THAT LASTS AT LEAST A YEAR AND
SUITABLE FOR ALL AGENTS AND
PATIENT TYPES.
MANY GROUPS AROUND THE WORLD USE
SLIGHTLY DIFFERENT ROLES IN
ACHIEVING THIS.
OUR GOAL AT NIAID IS TO STRIVE
FOR THE UNIVERSAL VACCINE THAT
PROTECTS BROADLY BUT ALSO MAKE
ADVANCES AGAINST STRAINS,
MULTIPLE SUB TYPES AND GROUP
VIRUSES.
TO THIS ENT A SINGLE
MANUFACTURING SITE AT DUKE, TWO
CLINICAL CORES AT DUKE AND THE
UNIVERSITY OF MARYLAND AND A
STATISTICAL DATA AND MANAGEMENT
AND COORDINATION CENTER
PRIMARILY RUN THROUGH DIGITAL
INFUSION BY DELOITTE AND MM SC.
THIS REPRESENTS A COLLABORATIVE
PROGRAM THROUGH DATE AND THE
DMID PROGRAMS.
WE'VE HAD STAGES OF PRECLINICAL
TESTING LEADING TO 13 PACKAGES
SUBMITTED FOR MANUFACTURING.
WE'VE MADE SIGNIFICANT PROGRESS
IN MOVING PRODUCTS THROUGH THE
CASCADE FROM DISCOVERY TO
PRE-TMP WORK AND PROCESS
DEVELOPMENT INTO GMP
MANUFACTURING AND JUST STARTING
TO TRANSITION INTO SOME OF THOSE
PROGRAMS INTO PHASE 1 TESTING.
WE'VE BEEN SUCCESSFUL AS WELL
MOVING TO CHALLENGE VIRUSES FOR
HUMAN CHALLENGE STUDIES FOR THE
H3N2 AND IS WIDELY AVAILABLE TO
THE RESEARCH COMMUNITY.
OUR H1N1 HUMAN VIRUS IS STILL
COMPLETING AND HOPEFULLY WILL
MOVE INTO CLINICAL TESTING TO
VALIDATE ITS UTILITY.
WE'VE MOVED ONE EXTERNAL
CANDIDATE FORWARD FOR PEDIATRIC
STUDIES AND THOSE RESULTS ARE
STILL PENDING.
IT'S IMPORTANT TO NOTE WE MOVED
A NUMBER OF NOVEL PRODUCTS WITH
MECHANISMS OF ACTION AND
BACKBONES AND LEVERAGES THE USE
OF CANDIDATE ADJUVANTS.
CLINICALLY WE'VE ACCOMPLISHED A
LOT.
WE HAVE SIX SITES CLINICALLY
ACTIVE THAT HAVE TO DATE
ENROLLED 550 INDIVIDUALS ACROSS
FIVE CLINICAL STUDIES SHOWN
HERE.
AND A CHALLENGE VIRUS IS NOW
AVAILABLE TO THE RESEARCH
COMMUNITY AND HOPEFULLY WILL
HAVE SOMETHING SIMILAR FOR H1N1
IN THE FUTURE.
ONE SIGNIFICANT DELIVERABLE FROM
THIS PROGRAM IS THE DEVELOPMENT
OF A LARGE AMOUNT OF DATA BOTH
FROM PRECLINICAL TO CLINICAL
TRIALS THAT ARE AVAILABLE TO THE
RESEARCH COMMUNITY.
DESPITE ALL OF THESE ADVANTAGES,
THE PROGRAM HAS HAD A NUMBER OF
CHALLENGES.
IT WAS A NEW TRANS DIVISIONAL
COLLABORATIVE PROGRAM WITH A
BROAD SCOPE OF RESEARCH
ACTIVITY.
SO IT TOOK LEARNING TO FIGURE
OUT HOW TO WORK EFFECTIVELY WITH
ONE ANOTHER AND MOVE TOGETHER IN
HARMONY AND WERE IMPACTED BY THE
SARS COV2 PANDEMIC DIRECTLY AND
INDIRECTLY THE CLEAR DIRECT
IMPACT IS ALL THE VACCINES WERE
ASKED TO TRANSITION AND FOCUS ON
SARS COV2 AND WE'LL CONTINUE TO
DO WORK ON THE PROGRAM.
ADDITIONALLY THERE WERE INDIRECT
THINGS LIKE DIFFICULTY FINDING
REAGENTS, ABILITY TO FIND THINGS
LIKE VIALS TO PRODUCE THE
VACCINES AND EVEN NOW STILL
CAUSING CHALLENGES WITH OUR
ABILITY TO PRODUCE VACCINES.
THE OTHER CHALLENGE IS WE
LEARNED A LOT ABOUT VACCINE
DEVELOPMENT.
WE HAD CHALLENGES IN THE PRODUCT
DEVELOPMENT AND STAGE OF THE
CENTERS THAT WERE DISCOVERING
THE VACCINES THAT WERE HANDED
AFTER TO DUKE OR OTHER PARTNERS
TO REALLY MOVE THE PRODUCT INTO
MANUFACTURING.
WHAT WE'VE LEARNED IS THIS NEEDS
TO BE AN ITERATIVE PROCESS WITH
EXPERT INPUT AND CLOSE
COLLABORATION WITH THE VACCINE
AND MANUFACTURING CENTER.
WE HAD SOME PRODUCTS THAT GOT
HUNG UP AT THAT STAGE.
WHEN WE WENT BACK AND TOLD THE
CENTER GO FIND A PARTNER TO WORK
WITH COLLABORATIVELY WE WERE
ABLE TO ACCELERATE THE PROGRAM.
WITH THIS RENEWAL WE HOPE TO
ADDRESS SOME OF THESE KEY
CHALLENGES BUT ALSO SIMPLIFYING
AND STREAMLINING THE PROGRAM
WHILE REMAINING ON FOCUS TO THE
PRODUCT DEVELOPMENT PLATFORM.
SO WE WANT THE GREAT SCIENCE TO
BE SUPPORTED BY THIS IN THE END
WE WANT VACCINE CANDIDATES THAT
MOVED THROUGH MANUFACTURING INTO
THE CLINICAL SETTING TO LEARN
AND IMPROVE ON VACCINES.
TO THIS END WE PROPOSED A
SIMPLIFIED PROGRAM OF THE CIVICS
PROGRAM.
.
IT WILL CONTINUE TO HAVE NIAID
CIVICS OVERSIGHT TEAM FOR A
COLLABORATIVE EFFORT BETWEEN
DATE AND DMID.
DATE WILL BE SUPPORTING AND
PRESENTING THE CONCEPT FOR THE
DATA MANAGEMENT AND COORDINATION
CENTER ALSO FUNDING THE EXTERNAL
ADVISORY GROUP.
THIS WILL BE AN EXTERNAL GROUP
OF EXPERTS TO ADVISE US ABOUT
THE VACCINE DEVELOPMENT.
THE CORNERSTONE OF THIS PROJECT
THAT WE'RE TALKING WE'RE
INCREASING THE NUMBERS FROM
THREE TO FIVE TO SIX WITH THE
GOAL OF HOPING TO HAVE MORE
GROUPS WORKING VERY CAREFULLY TO
MOVE PROJECTS FORWARD.
THE OTHER THING THAT'S GOING TO
CHANGE IS THE DUTY OF THE
VACCINE DEVELOPMENT CENTER TO
TAKE A CANDIDATE AND MOVE IT
THROUGH PROCESS INTO THE CLINIC.
THEY'LL HAVE TO PARTNER WITH
ORGANIZATIONS TO MOVE THIS
FORWARD.
WE'LL NOT BE FUNDING A SEPARATE
CORE.
WE'RE ALSO REQUESTING THE
CENTERS WHEN THEY COME INTO THE
GRANT THEY COME IN WITH WHAT'S
CALLED TECHNOLOGY READINESS
LEVEL 5 OR 6 CANDIDATE.
IT'S A CANDIDATE ARE THE WITHIN
A YEAR TO MOVE INTO GM P
MANUFACTURING.
SO THEY CAN MOVE FORWARD ON
OTHER VACCINE CANDIDATES.
WE'LL HAVE MANUFACTURING AND
PROCESS DEVELOPMENT AND TRIALS
AS SEPARATE OPTIONS AS THE
STRUCTURE.
EACH VACCINE DISCOVERY AND
DEVELOPMENT CENTER WILL NEED AN
ASSAY CORE RESPONSIBLE FOR
ASSAYS NOT PERFORMED BY THE
VACCINE TESTING SERVICES AND
THESE ARE THINGS THAT ARE
SPECIFIC TO THE INDIVIDUAL
VACCINE THEY ARE DEVELOPING.
THERE MAY BE SPECIFIC T AND B
CELL OR ANTIBODY RESPONSES
UNIQUE TO THEIR VACCINES NOT
PART OF TESTING ACROSS ALL
VACCINE CANDIDATE.
THOSE CONSISTENT TESTS WILL BE
PERFORMED BY THE VACCINE TESTING
SERVICES INCLUDING THE HA STOCK
AND INHIBITION ASSAYS.
IN ADDITION, THE VACCINE CENTERS
WILL BE ABLE TO WITH
CONSULTATION OF THE OVERSIGHT
TEAM TO USE GAP-FILLING TOOLS
THROUGHOUT THE NIAID SUPPORT
PROGRAM INCLUDING THINGS THROUGH
ADJUVANTS AND ANIMAL MODELS AND
STUDIES PLACED.
THEY'LL BE ABLE TO WORK WITH
VACCINE MANUFACTURING SERVICE TO
DEVELOP MASTER CELL BANKS AND
VIRUSES POTENTIALLY AND GMP
SUPPORT IF THEY AREN'T ABLE TO
FIND OTHER MECHANISMS TO MOVE
FORWARDS.
ANOTHER KEY CHANGE FOR THE
RENEWAL IS WE'LL BE LEVERAGING
THE NIAID INFRASTRUCTURE YOU'LL
HEAR ABOUT NEXT TO COMPLETE OUR
PHASE 2 AND TWO STUDIES.
IF WE DO CHALLENGE STUDIES IT
WILL STREAMLINE STORAGE AND
STATISTICAL MANAGEMENT OF THESE
STUDIES.
I HAD A WONDERFUL TIME CHATTING
WITH DR. ESTES AND PALMER AND
THEY CLARIFIED A FEW THINGS
HOPEFULLY I DID DURING THE
PRESENTATION AND TALK ABOUT WHAT
A TRL IS AND TAKING MORE
CONCEPTS FORWARD AND MOVE THINS
INTO PRODUCT DEVELOPMENT.
WITH THAT, THAT'S OUR RENEWAL.
HAPPY TO ANSWER ANY QUESTIONS
YOU MAY HAVE.
ANY QUESTIONS OR COMMENTS OR
COLLABORATIONS.
THANKS, MIKE.
OUR LAST DMID CONCEPT, SECOND TO
LAST OVER ALL IS GOING TO BE
PRESENTED BY ANDREW BURNHAM OF
THE OFFICE OF CLINICAL RESEARCH
RESOU
RESOURCES.
>> THANK YOU.
I'M A PROGRAM OFFICER IN THING
OFF OF CLINICAL RESEARCH
RESOURCES.
THIS IS CALLED THE CLINICAL
RESEARCH OPERATIONS CORE WITH
ACTIVITIES THAT ADDRESS
SCIENTIFIC PRIORITIES.
THE IS A NEW INITIATIVE AND
WE'LL BE USING A CONTRACT
MECHANISM.
WE ANTICIPATE MAKING ONE.
OF WAY AS BACKGROUND AS YOU SAW
THROUGH MANY PRESENTATIONS WE
SUPPORT THE BROAD RANGE OF
CLINICAL RESEARCH.
THIS INCLUDES PHASE 0-4 CLINICAL
TRIALS IN THERAPEUTICS AND
VACCINES.
COHORT STUDIES AND EVALUATION OF
NEW DIAGNOSTICS AND LOOK AT
POTENTIAL AGENTS OF BIO
TERRORISM AND NIAID PRIORITY
PATHOGENS.
WITH THE INFRASTRUCTURE IT'S
PLAY A ROLE IN THE DMID
SCIENTIFIC PRIVATES.
LESSONS LEARNED FROM RECENT
CLINICAL TRIALS AND OUTBREAKS
DEMONSTRATED FUNDING OF
OPERATIONS IN SITES AND RAPIDLY
RESPOND DURING PUBLIC HEALTH
EMERGENCIES.
FOR EXAMPLE, THEY CONDUCTED
MULTIPLE PHASE III TRIALS AS
PART OF OUR COVID-19 RESPONSE.
THE SPEED AT WHICH THE TRIALS
CAME ONLINE AND LATER EVOLVED
OUTPACED THE ABILITY OF OUR
SYSTEMS.
SO THE CLINICAL RESEARCH
OPERATIONS CORE WILL PROVIDER A
RESEARCH FOR CLINICAL TRIALS AND
RESEARCH ACROSS DMID'S
SCIENTIFIC PRIORITIES.
THE CORE WILL PROMOTE EFFICIENT
COORDINATION OF OPERATIONS
ACROSS AREAS.
SPECIFICALLY, THE OPS CORE WILL
OVERSEE AND MANAGE THE FOLLOWING
ACTIVITIES, PROTOCOL DEVELOPMENT
WHERE IT WILL OVERSEE AND
DEVELOP PROTOCOLS, NFK INFORMED
CONSENT FORMS AND SITE SELECTION
TO IDENTIFY SITES FROM ACROSS
NIAID'S INFRASTRUCTURE THAT BEST
MEET THE NEEDS OF THE STUDY.
STUDY MANAGEMENT WHERE LL -- IT
WILL OVERSEE AND START UP AND
CLOSE OUT ACTIVITIES AND
COORDINATION WHERE IT WILL
COORDINATE WITH VARIOUS
STAKEHOLDERS TO ENSURE TIMELY
DISSEMINATION OF RESULTS.
THIS IS WHERE WE SEE THESE
ACTIVITIES TO BE ADDITIVE OR AS
NEW NOOEDZ COME YONL LINE
THEY'RE ABLE TO BE MET WITH NEW
RESOURCES WHILE WE ARE ABLE TO
CONTINUE WITH THE CURRENT
ACTIVITIES.
WE ALSO ANTICIPATE SOME OF THESE
ACTIVITIES COULD BE CONDUCTED IN
PARALLEL DURING A PANDEMIC
RESPONSE OR RAPID RESPONSE TYPE
SITUATION.
THE OPS CORE WILL OPERATIONALIZE
CLINICAL TRIALS DEVELOPED BY
SCIENTIFIC NETWORKS AND IN
RESPONSE TO EMERGING AND
RE-EMERGING DISEASE OUTBREAKS.
AS DR. ISON MENTIONED THE OPS
CORE WILL RUN THE CLINICAL
TRIALS DEVELOPED BY THE CIVICS
PROGRAM.
THE YEAR ONE ACTIVITIES WILL
FOCUS ON INFLUENZA VACCINE
TRIALS WITH LATER EXPANSION TO
PRIORITIES.
SO FOR COUNCIL FEEDBACK I WAS
ABLE TO MEET WITH DOCTORS TAYOR
AND BOCKENSTEDT AND INDICATED
SUPPORT.
THE COMMENTS AND FEEDBACK WERE
TO EMPHASIZE HOW THE OPS CORE
COULD RESPONSE IN THE FUTURE
BASED ON THE LESSONS LEARNED.
AND BE HAPPY TO TAKE QUESTIONS.
>> HOW IS THIS DIFFERENT FROM
THE BTUs.
>> THIS IS A FUTURE INITIATIVE
TO OPERATIONALIZE THE TRIALS
ACROSS THE NETWORKS.
>> WE HAVE LEADERSHIP GROUPS IN
CONTROL OF GRANTS WHICH END UP
BEING A LESS MECHANISM FOR
FLOWING PROTOCOL FUNDS IN A
PUBLIC HEALTH EMERGENCY.
THERE ARE SPECIFIC CHALLENGES
CREATED DURING COVID.
>> THE VTUs ARE A LONG STANDING
PROGRAM FOR NIAID AND LEVERAGED
THEM AS BEST WE COULD.
WE'RE LOOKING -- WHAT WE LEARNED
IN THE PANDEMIC WAS A BIGGER
SCOPE OF TRIALS, MULTICENTER
SOMETIMES 50, 60, 70 CENTERS FOR
TRIALS AND BEING ABLE TO RESPOND
TO A PANDEMIC IN THAT SITUATION
WE LOOKED FOR DIFFERENT
MECHANISMS TO INCREASE OUR
FLEXIBILITY AND SO THAT'S WHERE
THE IDEAS WERE BORN FROM.
?
AND A NEW AWARD TO I AA -- TO A
NEW SITE AND SCALING UP TO NEW
OPERATIONS WHEN THAT WAS
REQUIRED ARE THE SORTS OF THINGS
CONTRACTS OFTEN DO BETTER IN OR
ALLOW US TO DO BETTER THAN IN A
GRANT MECHANISM.
>> ANY OTHER COMMENTS OR
QUESTIONS FOR ANDY?
>> THANK YOU.
>> THANK YOU SO, WE'RE BEING
VERY EFFICIENT.
THE NEXT CONCEPT FROM THE
DIVISION OF CLINICAL RESEARCH
AND I THINK I SAW DR. CONNIE
SCHMALJOHN'S NAME.
>> I'M SHARING MY SLIDES.
CAN YOU SEE THEM?
>> YES.
GOOD AFTERNOON I'M THE DIRECTOR
AT IRF-FREDERICK.
I'M PART OF THING OFF OF
SCIENTIFIC AND ADMINISTRATIVE
MANAGEMENT AND THANK YOU FOR
ALLOWING ME TO INTRUDE ON THIS
MEETING AND ALLOWING ME TO DO
THIS VIRTUALLY SO I DON'T HAVE
TO DRIVE THIS TIME OF DAY.
THE CONCEPT I AM PRESENTING IS
THE RECOMPETE FOR RENEWAL OF THE
OPERATIONS AND MANAGEMENT FOR
THE NIAID INTEGRATED RESEARCH
FACILITY AT FORT DETRICK FOR THE
IRF FREDERICK.
IT'S A CONTINUATION OF
SCIENTIFIC ADMINISTRATIVE
OPERATIONS AT THE IRF FREDERICK
TO FACILITATE THE PROGRAM AND
THE MISSION AND PORTFOLIO.
THIS IS A RENEWAL OR RECOMPETE
OF THE OPERATIONS CONTRACT.
IT'S THE NATIONAL RESOURCE AND S
OPPORTUNITIES FOR MAXIMUM
CONTAINMENT RESEARCH TO
GOVERNMENT, ACADEMIA AND
INDUSTRY PARTNERS WHO COULD NOT
OTHERWISE CONDUCT SUCH RESEARCH.
WE HAVE THE FACILITY CAPABLE OF
ANIMAL MODELS OF DISEASE IN A
SETTING AND THE PICTURES SHOW AN
ILLUSTRATION AND THERE'S A
SCIENTIST IN THE LEVEL 4 LAB AND
THE ANIMAL IS ON THE CONVEYOR
TABLE READY TO GO THROUGH THE
PORT IN THE WALL WHICH MAINTAIN
THE ENVIRONMENT THOUGH THE BSL
PORTION OF THE BUILDING THE
MACHINE MOVES OVER THE TUBE FOR
THE IMAGING AND THE ANIMAL IS
RETURNED TO THE BSL-4 PORTION OF
THE LABORATORY.
SOME CAPABILITIES INCLUDING
IMAGING OF ALL SIZES OF ANIMAL,
11,000 SQUARE FEET OF THE
LABORATORY SPACE AND HOLDING
ROOMS AND ANIMAL ROOMS AND THE
NECROPSY SUITE AND SMALL
PARTICLE AEROBIOLOGY AND
SUPPORTING SPACING AND
BORT-CERTIFIED PATHOLOGISTS AND
A.I. EXPERTISE AND ORGAN-ON-CHIP
AND LABORATORY AND TRAINING FOR
THE CLINICAL STUDIES IN RESOURCE
FOR POOR SETTINGS PRIMARILY IN
AFRICA.
IT'S TO SERVE AS A RESPONSIVE
AND COLLABORATIVE RESOURCE TO
UNDERSTAND, TREAT AND ERADICATE
DISEASES CAUSED BY NOVEL
EMERGING AND VIRULENT PATHOGENS
AND THIS IS HOW WE DEVELOP THE
PORTFOLIO AND SELECT PROJECTS
AND THE LAB LOCATED IN MONTANA
AND UNLIKE RM11 FREDERICK DOES
NOT DO P.I. RESEARCH BUT SORT
THE WORK OF GOVERNMENT, INDUSTRY
AND ACADEMIC PARTNERS.
RESEARCH PROPOSALS WORK WITH
PA
PARTNERS HAVE THE FINAL REVIEW
OF THE STEERING COMMITTEE.
IF WE DO DECIDE TO DO PROJECTS
AT THE IRF FREDERICK THE
EXPENSES ARE LIMITED TO PURCHASE
OF ANIMALS AND IF THERE ARE ANY
NON-STANDARD SPECIALTY
RE-AGENTS.
THE BUILDING CONSTRUCTION
STARTED IN 2005 AND THE FIRST
SERVICES SUPPORT CONTRACT WAS
AWARDED IN 2007 TO BATTEL.
IN 2011 IT ABECAME OPERATIONAL
AND IN 2012 LEVEL 4 CONSTRUCTION
WAS CLEATED IN 2014 CDC SELECT
AGENT APPROVAL WAS GRANTED AND
IN 2020 THE PROJECT WAS
RECOMPETED AND IN 2020 AWARDED.
THE NEW COMPANY LA LIMA
GOVERNMENT SOLUTIONS.
THE FIRST CONTRACT ENDS IN
FEBRUARY OF 2027.
THIS IS FROM THE COVER OF THE
ANNUAL REPORT LISTING
ACCOMPLISHMENTS FOR THAT YEAR.
IT INCLUDES 94 PUBLICATION AND
COLLABORATION AGREEMENT AND
TRANSFER AGREEMENTS AND
PRESENTATIONS AT NATIONAL AND
INTERNATIONAL CONFERENCES AND
CLINICAL TRIAL SUPPORT FOR STUDY
IN LIBERIA AND IN THE REPUBLIC
OF CONGO.
I LISTED SOME OF THE MORE HIGH
PROFILE PUBLICATIONS IN THE LAST
COUPLE YEARS TO TRY TO
ILLUSTRATE THE DIFFERENT AREAS
OF WORK WE FACILITATED.
THERE'S MRNA VACCINATION AND IT
CAN EXPAND CLONALO TYPES
UNDETECTABLE OF SARS COV2
INFECTION AND PATHOLOGISTS USED
SPECIMENS FROM A MONKEY STUDY
NOT COMPETED ON THE EBOLA VIRUS
TO LOOK AT THE ABNORMALITY AND
FOUND THAT EEBL -- EBOLA VIRUS
COULD OCCUR AND DISEASE
PROGRESSION WAS ASSOCIATED
WITHEMWI
WITHEMWITH
HEMATOPOIETIC FAILURE AND THE
SECOND WAS IN A COLLABORATION
WHERE THEY ISOLATED MONOCLONAL
ANTIBODIES TO SARS COV2.
THE SECOND STUDY WAS CONDUCTED
WITH PARTNERS IN AFRICA LOOKING
AT PREGNANCY OUTCOMES AFTER
EBOLA VIRUS RECOVERY.
THE FOLLOWING WAS ANOTHER STUDY
AND THE LAST ONE WAS A
COLLABORATION WITH THE CENTER
FOR IMAGING AND INFECTIOUS
DISEASE IMAGING AT NIH AND
INCLUDED OUR A.I. EXPERT WHO
PARTICIPATED IN THAT STUDY THE
SUPPORT CONTRACT WILL SERVE AS A
NATIONAL RESOURCE FOR LEVEL-2
LABORATORY WORK.
IT INCLUDES DEVELOPING ANIMAL
MODELS FOR HUMAN DISEASE CAUSED
BY HIGHLY PATHOGENIC VIRUSES AND
CUTTING EDGE METHODS UNDER
METHOD OF PATHOGENESIS AND THE
EVALUATION OF COUNTER MEASURES
TO TREAT DISEASE AND PROVIDES
PERSONNEL TO SUPPORT CLINICAL
STUDIES IN AFRICA.
USING A UNIQUE OPERATING MODEL
WITH INTRAMURAL AND EXTRAMURAL
COMPONENTS.
WE'RE WORKING TO REVISE THE
STATEMENT OF WORK WHERE IT IS
NECESSARY TO ADDRESS CHANGED
PRIORITIES AND THIS COMES FROM
THE MOST RECENT REPORT PROVIDED
TO THE GOVERNMENT BY LA LIMA AND
CHOSE THE WORKFORCE.
WE HAVE 111 CONTRACT PERSONNEL
FROM LA LIMA AND THEIR
SUBCONTRACTOR.
BUT IN ADDITION TO THE WORKFORCE
THE THERE'S TWO CONTRACTORS FROM
LIDOS AND FOUR GOVERNMENT FTE
INCLUDING ME AND ONE PUBLIC
HEALTH OFFICER A HUMAN
PATHOLOGIST AND ON SITE SUPPORT
FROM THE DIVISION OF CLINICAL
RESEARCH OF PROGRAMS AND BUDGET
BRANCH AND NIH INFORMATION OF
TECHNOLOGY SERVICES AND RESEARCH
FACILITIES AND CONTRACTED
SECURITY GUARDS AND THE NUMBERS
AFTER EACH ARE HOW MANY OF THAT
PARTICULAR TYPE OF PERSONNEL WE
HAVE ON SITE AT THE IRF
FREDERICK.
AGAIN, I VERY MUCH THANK DOCTORS
PALMER AND BOCKENSTEDT
EXPLAINING WHAT I'M SUPPOSED TO
DO AND I SPENT THE TIME TRYING
TO EXPLAIN WHAT THE
IRF-FREDERICK IS BECAUSE I THINK
A LOT OF PEOPLE SIMPLY DON'T
UNDERSTAND HOW WE FIT INTO THE
OVER ALL SCHEME OF NIAID AND NIH
AND HOW WE DIFFER FROM RML.
WHAT ARE OUR PUBLICATIONS THE
SPECTRUM OF THE TYPE OF WORK WE
DO AND THE IN THE PICTURE AND
ABBREVIATIONS.
THANK YOU BOTH FOR POINTING OUT
TO ME I NEED TO BE A LITTLE
CLEARER IN MY PRESENTATIONS.
ALL IN ALL, THEY WERE BOTH QUITE
SUPPORTIVE OF CONTINUING THIS
PROJECT.
WITH THAT AIL STOP AND SEE IF
ANYBODY HAS ANY QUESTIONS.
>> THANK YOU, CONNIE.
THE FLOOR'S.
TO QUESTIONS.
QUESTIONS FROM COUNCIL MEMBERS
OR ADDITIONAL COMMENTS?
>> OKAY.
>> YOU'VE CLARIFIED THE
DIFFERENCE BETWEEN THE ROCKY
MOUNTAIN LAB AND YOUR LAB.
THANKS, CONNIE.
>> THANK YOU.
OKAY.
I THINK THAT CONCLUDES OUR --
WE'VE GONE THROUGH THE ENTIRE
AGENDA OF CONCEPTS FOR
CLEARANCE.
WE DO NEED TO ASK YOU TO EN TUR
YOU'RE VOTE INTO THE ELECTRONIC
COUNCIL BOOK THAT IS BOTH
COUNCIL MEMBERS REMOTELY
PARTICIPATING AS WELL AS THOSE
IN THE ROOM.
THEY WILL COME AFTER YOU IF YOU
NEGLECT.
I THINK OTHERWISE WE ARE
ADJOURNED.
THANK YOU ALL.