>>WELCOME TO THE OPEN SESSION
OF THE DIVISION OF MICROBIOLOGY
AND INFECTIOUS DISEASE
SUBCOMMITTEE OF COUNCIL.
I'M JUST GOING TO START OFF WITH
A FEW OF MY--A FEW REMARKS AND
LET'S SEE, SO, OKAY, HERE WE GO,
SO SOMEBODY'S RUNNING THE SLIDES
FOR ME, IT LOOKS LIKE, GOOD.
SO HERE'S THE AGENDA FOR TODAY,
STARTING WITH THE DIRECTOR'S
REPORT, I WILL GIVE YOU SOME
PERSONNEL UPDATES, I WILL
HIGHLIGHT A FEW BITS OF RESEARCH
NEWS.
I AM GOING TO THEN PRESENT YOU
WITH AN FY23 CONCEPT.
AND I'M GOING TO ASK FOR YOUR
APPROVAL OF THAT AND ALSO THE
FISCAL YEAR 23 SBIR CONTRACT
TOPICS FROM BOTH THE DIVISION OF
MICROBIOLOGY AND INFECTIOUS
DISEASE ANDS FROM 1 OF OUR
COLLEAGUES AT THE OFFICE OF DATA
SCIENCE AND EMERGING
TECHNOLOGIES AND THEN WE WILL GO
INTO OUR CONSEPTD PRESENTATION
BY MEMBERS OF DMIDS PROGRAM
STAFF.
NEXT SLIDE, PLEASE.
SO FIRST OF ALL, NEW STAFF, I
JUST WANT TO INTRODUCE YOU
VIRTUALLY TO SOME PEOPLE WHO
HAVE BEEN BROUGHT ON BOARD SINCE
THE LAST TIME THAT WE MET.
CATHERIN BIGGER IS IN THE OBRRTR
SECTION, SHE IS A VIROLOGIST AND
THE JOINT PROGRAM EXECUTIVE
OFFICE FOR CBRN DEFENSE WHERE
SHE WAS SERVING IN AN ADVISORY
ROLE FOR MEDICAL MEASURE COUNTER
DEVELOPMENT FOR BIOWARFARE
AGENTS.
AND THEN OLIVIA SPARER JOINED A
COUPLE MONTHS AGO, SO SHE TOOK
ON A NEW ROLE AND SHE'S
EXPANDING OUR ROLE WITH THE
OFFICE OF CLINICAL RESEARCH
RESOURCES AND THE INFECTIOUS
DISEASE CLINICAL RESEARCH
DISEASE WORK AS A PROGRAM
OFFICER AND AS A MANAGEMENT
ANALYST.
NEXT SLIDE, PLEASE.
BRENDA LARKIN IS A PROGRAM
OFFICER ALSO IN THE OFFICE OF
CLINICAL RESEARCH RESOURCES AND
SHE WILL WORK WITH IDCRC AND THE
VTEUs BEFORE COMING TO DMID,
SHE SPENT SEVERAL YEARS AT
NIAID'S VACCINE RESEARCH CENTER
WORKING ON VACCINE TESTING FOR
HIV AND OTHER BIODEFENSE
PATHOGENS AND THEN KRISTA, CATO,
WHO IS A NURSE CONSULTANT WHO IS
JOINING THE ENTERIC AND STI
BRANCH WHERE SHE WILL SERVE AS A
PROJECTED MANAGER, PRIOR TO
JOINING OUR TEAM SHE OVERSAW
IMPLEMENTATION AND PROTOCOL FOR
THE NURSING PEDIATRIC OF CARE
AT----BRENDA AND KRISTA, AND
NEXT SLIDE, PLEASE AND THEN
WE'VE HAD 1 SIGNIFICANT
DEPARTURE, ALAN WAS THE CHIEF OF
THE RESPIRATORY BRANCH UNTIL
JUST THIS PAST MONTH HE HAD BEEN
INFORMALLY DETAILED TO
DR. FAUCI'S OFFICE WHERE HE
SERVED AS A SENIOR ADVISOR FOR
PANDEMIC PREPAREDNESS AND HE
RECENTLY LEFT NIAID TO TAKE A
POSITION IN THE PRIVATE SECTOR
AND SEPARATE FROM FEDERAL
SERVICE THAT WE HOPE HE WILL
COME BACK SOMEDAY.
NOW, TERESA HAUGEL IS NOT
LEAVING, SHE IS ACTING CHIEF OF
THE RESPIRATORY BRANCH AND I AM
GLAD SHE WAS ABLE TO TAKE ON
THESE ADDITIONAL DUTIES IN,A
DITION TO EVERYTHING ELSE THAT
SHE'S RESPONSIBLE FOR SO NOW I
WILL HIGHLIGHT RESEARCH NEWS,
CONDUCTED BY OUR EXTRAMURAL
INVESTIGATORS AND SUPPORTED BY
OUR DMIDRESOURCES.
ONE OF OUR MOST INTENSE EFFORTS
IN THE PAST YEAR FOR THE
PANDEMIC RESPONSE HAS BEEN THE
DMID MIX AND MATCH CLINICAL
TRIAL WHICH WAS DESIGNED TO TEST
THE SAFETY AND IMMUNE O
GENESISISSITY OF ALL POSSIBLE
COMBINATIONS OF LICENSED AND
AUTHORIZED SARS-COV-2 VACCINES
WHEN THEY WERE USED AS A PRIME
OR A BOOST IN COMBINATION OF
WITH OTHER VACCINES.
SO A PRELIMINARY REPORT OF
RESULTS WAS PUBLISHED IN THE NEW
ENGLAND JOURNAL IN OCTOBER AND
THEN THESE DATA,OT PRIMING AND
BOOSTING COMBINATIONS WAS ALSO
PRESENTED TO THE FDA VP A C, AND
TO THE ACIP AND THESE PROVIDED A
BASIS FOR THE RECOMMENDATION OF
THE ACIP ULTIMATELY, WHAT
ULTIMATELY CAME OUT OF THE ACIP,
AND BUT DIFFERENT MRNA VACCINES
COULD BE COMBINED SAFELY IN
PRIME BOOST COMBINATIONS AND THE
STUDY ALSO PROVIDED A VIEWS FOR
MRNA VACCINES FOLLOWING THE J&
JR VACCINE.
SAMPLES FROM THIS STUDY PROVIDED
DATA SHOWED THAT BOOSTING
GENERATED NEUTRALIZING ANTIBODY
RESPONSE THAT WOULD BE PARTIALLY
EFFECTIVE AGAINST THE OMICRON
VARIANT WHICH WAS VERY VARIANTS
OF CONCERN.
NEXT SLIDE, PLEASE.
INVESTIGATORS AT THE UNIVERSITY
OF PENNSYLVANIA SRMTED THROUGH
OUR CENTERS OF EXCELLENCE AND
INFLUENZA RESEARCH AND RESPONSE
REPORTED IN DECEMBER, JUDGE UTV
A FEW WEEKS AGO IN A PREPRINT
THAT PREEXISTING IMMUNITY
AGAINST CURRENTLY CIRCULATING H3
N2 VIRUSES IS LOW.
AND THAT CIRCULATING STRAINS MAY
NOT BE WELL NEUTRALIZED BY
ANTIBODIES THAT ARE GENERATED BY
THE NORTHERN HEMISPHERE VACCINE.
THIS IS BECAUSE THERE HAVE BEEN
SEVERAL NEW SUBTUITIONS THAT
HAVE EVOLVED RELATIVE TO THE
2021-22 STRAIN SELECTION FOR
THAT VACCINE.
WE DID NOT HAVE A SIGNIFICANT
FLU VACCINE IN 2020-21 BUT I'M
CONCLUDE FREE RADICALS GENERATED
THESE DATA THAT THESE
NONPHARMACEUTICAL INTERVENTIONS
THAT MIGHT HAVE MINIMIZED
INFLUENZA TRANSMISSION LAST YEAR
SUCH AS MASKING AND SOCIAL
DISTANCING ALSO MIGHT CONTINUE
TO PROVIDE BENEFIT TO US DURING
THIS RESPIRATORY VIRUS SEASON.
NEXT SLIDE, PLEASE.
STAFF MEMBERS IN OUR OFFICE OF
BIODEFENSE AND TRANSLATIONAL
RESEARCH RESOURCES WHAT WE CALL
OBRRTR, IN DMIDGENERATED DATA
FOR THE FDA THAT,A LOWED FOR
ANIMAL MODEL QUALIFICATION
THROUGH THE FDA DRUG DEVELOPMENT
TOOL PROGRAM.
IN IS THE FIRST TIME THAT
AN ANIMAL MODEL HAS BEEN
QUALIFIED IN THAT PROGRAM.
THIS IS THE RESULT OF OVER 10
YEARS OF WORK ON THE PART OF
DMIDAND FDA STAFF AND THIS
ANIMAL MODEL IS QUALIFIED FOR
TESTING THERAPEUTICS AGAINST
[INDISCERNIBLE], AND THIS WILL
ALLOW FOR NIAID AND INDUSTRY
PARTNERS TO APPROVE DRUGS OF
THERAPEUTIC TREATMENTS FOR
[INDISCERNIBLE] USING THE ANIMAL
PATHWAY.
NEXT SLIDE, PLEASE.
A NUMBER OF DMID STAFF MEMBERS
HAVE RECEIVED AWARDS SINCE LAST
TIME WE MET AND I WOULD LIKE TO
RECOGNIZE THEM.
OF THOSE THAT ARE IN OUR
COMMISSIONED CORPS, THE PUBLIC
HEALTH SERVICE AWARDS
DR. CHRISTINA CARDEMIL RECEIVED
OUTSTANDING SERVICE MEDAL FOR
CONTINUING OUTSTANDING
LEADERSHIP IN GLOBAL AND
DOMESTIC DISEASE PREVENTION AND
CONTROL.
DR. LORI NEWMAN RECEIVED
ACCOMMODATION FOR TRAINING OF
STAFF FROM NIH AND OTHER
AGENCIES IN OPIOID OVERDOSE
RESPONSE IN RESPONSE TO THE
NATIONAL EPIDEMIC ON OPIOID
OVERDOSE.
AND JOHN PESCE, COMBINATION FOR
2 PROJECTS IF PARTICIPATION IN
THE FDA OPIOID OVERDOSE RESPONSE
AND NALOXONE TRAINING TEAM AND
ALSO FOR HIS CONTRIBUTIONS TO
THE PACE OPIOID PLAN DEVELOPMENT
TEAM.
>> NEXT SLIDE, PLEASE.
THE HARRIET P. DUSTIN AWARD IS
BESTOWED FOR OUTSTANDING WORK IN
SCIENCE AS IT RELATES TO
MEDICINE AND SCIENTISTS IN ANY
FIELD, ANY COUNTRY CLINICAL,
NONCLINICAL, CHEMICAL,
NONCHEMICAL, BIOPHYSICAL ARE ALL
ELELIMINATEDDIBLE FOR THE AWARD,
THE MAJOR CONTRIBUTION WOULD BE
THAT THE AWARDEE MADE AN
OUTSTANDING CONTRIBUTION THAT
HAS BEEN NATIONALLY OR
INTERNATIONALLY RECOGNIZED WE
ARE PLEASED THAT DR. JOHN BIGEL,
RECEIVED THIS AWARD FOR HIS
LEADERSHIP IN LAUNCHING AND
IMPLEMENTING THE ACT STUDIES
DURING THE CURRENT PANDEMIC.
NEXT SLIDE, PLEASE.
SO DR. FAUCI, MENTIONED OUR
WORKSHOP ON PANDEMIC
PREPAREDNESS AND HOW WE DELVED
INTO THE PROTOTYPE PATHOGEN
APPROACH TO ACCELERATE THE
DEVELOPMENT OF MEDICAL
COUNTERMEASURES AT THAT
WORKSHOP.
THIS WORKSHOP WAS THE--THE HAGZ
RATIONAL WAS TO FOCUS I
HAVEROLOGYSTS AND OTHER THOUGHT
LEADERS ON OUR PROTOTYPE
PATHOGEN PLAN AND AS YOU MIGHT
RECALL, THAT'S BASED UPON THE
CONCEPT THAT THERE'S PROBABLY
ONLY A LIMITED NUMBER OF--EVEN
THOUGH IT SEEMS AN INFINITE
NUMBER OF RNA VIRUSES OUT THERE,
THERE'S A LIMITED NUMBER OF
VIRAL FAMILIES THAT ARE LIKELY
TO SPILL OVER FROM THEIR
ZOONOTIC RESERVOIR AND CAUSE AN
OUTBREAK OR AN EPIDEMIC OR A
PANDEMIC THAT IMPACTS HUMANS.
SO THIS--IF WE KNOW WHAT THOSE
FAMILIES ARE, PERHAPS WE CAN
DEVELOP PROTOTYPE VACCINES
AGAINST PATHOGENS AND BE BETTER
PREPARED SHOULD AN EPIDEMIC
ARISE FROM A VIRUS WITHIN THAT
FAMILY.
SO AT THIS WORKSHOP WHICH WAS
LED BY CHRISTINA [INDISCERNIBLE]
OUR DEPUTY DIRECTOR VIROLOGYST,
AND TO IDENTIFY GAPS AND
KNOWLEDGES IN THESE PATHOGENS
AND PROPOSE SPECIFIC VIRUSES
WITHIN THAT FAMILY THAT WE
SHOULD SUPPORT MORE INTENSIVE
STUDY IN THAT MIGHT REPRESENT
THE BEST PROTOTYPE THAT MIGHT
LEAD TO RESEARCH THAT MIGHT LEAD
TOWARD AN EFFICACIOUS VACCINE.
SO NEXT SLIDE, SO THE FAMILIES
OF RNA VIRUSES MOST LIKELY TO
CAUSE SIGNIFICANT EPIDEMICS OR
PANDEMICS ARE DEPICTED ON THIS
SLIDE AND IN THE PAST 2 YEARS
WE'VE MADE SUBSTANTIAL
INVESTMENTS IN VACCINES FOR
CORONAVIRUSS AND ALSO FOR
ORTHOMYXOVIRIDACE, THAT INCLUDES
INFLUENZA A, MAYBE WITH THE
EXCEPTION OF THE FILO I HAVE
RIEROUSS, WE PROBABLY LACK THE
FOUNDATION TO RESPOND QUICKLY
SHOULD A SPILL OVER FROM A
ZOONOTIC RESERVOIR LEAD TO AN
EMDIPPIC, AND FOR THE HIGH
CONSEQUENCE PATHOGENS THERE HAS
BEEN SIGNIFICANT SUCCESS IN
DEVELOPING SEVERAL VACCINES THAT
ARE NOW AVAILABLE ON THE
COMMERCIAL MARKET.
SO WHILE THERE'S MORE WORK TO BE
DONE FOR THE FILOs, THIS IS
NOT AN AREA THAT HAS BEEN
NEGLECTED.
SO NEXT SLIDE, PLEASE.
SO THIS LEADS ME TO ASK FOR
APPROVAL FOR WHAT WE HOPE WILL
BECOME AN FY23 CONCEPT AND I'LL
PRESENT YOU THE RATIONAL NOW AND
WHAT WE PROPOSE TO DO.
I WILL JUST NOTE, WE DO NOT HAVE
ACCESS TO FUNDS TO SUPPORT THIS
RIGHT NOW.
THERE IS TALK OF IMPROVING OUR
ABILITY TO RESPOND TO A
PANDEMIC, AND OTHER SOURCE OF
PANDEMICS IN THE FUTURE, THERE'S
INTEREST IN NIAID, AND THE REST
OF THE NIH IN SUPPORTING
RESEARCH IN THIS AREA, AND THERE
MAY BE APPROPRIATIONS EITHER
SPECIFICALLY TO NIAID FOR
PANDEMIC PREPAREDNESS IN THE
FUTURE OR SOMETHING THAT MIGHT
COME TO THE DEPARTMENT OF HEALTH
AND HUMAN SERVICES THAT WOULD BE
TRANSFERRED TO US IN ORDER TO
ADDRESS THIS.
WE'RE NOT PROPOSING THAT
ANYTHING, THAT ANY FUNDS THAT
WOULD COME OUT OF THIS CONCEPT
THAT WOULD SUPPORT PROJECTS IN
THIS CONCEPT WOULD TAKE AWAY
FROM THE PAY LINE OR ANOTHER
INVESTIGATOR INITIATED STUDIES.
SO THE TITLE OF THIS IS RESEARCH
CENTERS TO DEVELOP VACCINES IN
MONOCLONAL ANTIBODIES FOR
PANDEMIC PREPAREDNESS, THE
OBJECTIVES WOULD BE TO ADVANCE
THE KNOWLEDGE NEEDED TO DEVELOP
VACCINES AND MONOCLONE AT
ANTIBODIES FOR PROTOTYPE VIRAL
PATHOGENS AND THE VIRUS FAMILIES
THAT HAVE PANDEMIC POTENTIAL FOR
WHICH WE CURRENTLY DON'T HAVE
IT.
SO, THE KEY FEATURES, AND THE
FOCUS OF THESE PROPOSED CENTERS
ARE SUMMARIZED ON THIS SLIDE,
AND THE 5 FAMILY VIRAL FAMILIES
FOR WHICH WE DON'T HAVE ADEQUATE
KNOWLEDGE TO EVEN THINK ABOUT
APPROACHING A VACCINE FOR SOME
OF THE MEMBERS OF THE VIRAL
FAMILIES AT LEAST ARE DEPICTED
ON THE RIGHT.
THE CENTERS WOULD INCLUDE
MULTIDISCIPLINARY TEAMS THAT
WOULD BE FOCUSED ON BASIC I
HAVEROLOGY, STRUCTURAL BIOLOGY,
ANTIGEN MAPPING AND INVITRO
TESTING AND/OR MODEL DEVELOPMENT
AS WELL AS VAC SEEB AND
MONOCLONAL ANTIBODY TESTING AND
I& D ENABLING RESEARCH THAT
COULD LEAD TO HUMAN TRIALS IN
HUMANS PHASE 1 CLINICAL TRIALS
SO THE FOCUS WOULD BE ON
PROTOTYPE PATHOGENS THAT ARE
IDENTIFIED IN THE WORKSHOP--OR
PERHAPS MORE THE STAGE OF
DEVELOPMENT THAT COULD BE
SUPPORTED BY THESE CENTERS, FOR
THOSE VIRUSES THAT WE HAVE VERY
LITTLE UNDERSTANDING OF THE
VIRUS LIFE CYCLE FOR EXAMPLE,
THE CENTERS MIGHT SUPPORT BASIC
RESEARCH, STRUCTURAL BIOLOGY,
AND/OR MODEL DEVELOPMENT MOVING
ALONG TO ANTIGEN DESIGN, ASSAY
DEVELOPMENT AND KREENING FOR
ACTIVITY OF THAT PROPOSED
COUNTER MEASURE, MOVING ON TO
ADJUVANT PAIRING AND TESTING AND
I& D ENABLING STUDYINGS WHICH
IT MIGHT ULTIMATELY LEAD TO A
PHASE 1 CLINICAL TRIAL.
AND THEN A TRANSITION TO
PARTNERS THAT MIGHT TAKE IT FOR
FURTHER PERHAPS
COMMERCIALIZATION.
NEXT SLIDE, PLEASE.
AND THEN SUMMARIZED ON THIS
SLIDE, WE DEPICT HOW WE WOULD
PROPOSE THAT THIS PROGRAM COULD
INTERACT WITH OTHER RESEARCH
PROGRAMS WITH PROGRAMS SUPPORTED
BY OUR DIVISION.
MANY OF YOU MIGHT BE FAMILIAR
WITH THE CENTERS FOR RESEARCH
AND EMERGING INFECTIOUS DISEASES
OR THE CREEDS.
WE ENVISION THESE ARE
LONGITUDINAL STUDIES AND WHERE
SAMPLES ARE COLLECTED THAT MIGHT
BE APPROXIMATE TO WHERE SPILL
OVER EVENTS FROM ZOONOTIC
RESERVOIRS MIGHT BE, THIS
PROGRAM COULD SUPPORT THE
REAGENTS AND PERHAPS CLINICAL
SALES FOR THESE PROPOSED
RESEARCH CENTERS TO USE.
WE HAVE STRUCTURAL GENOMIC
CENTERS WHICH ARE WITH
STRUCTURAL BIOLOGY AND HELP
SOLVE ANTIGEN STRUCTURE IF THAT
HAPPENED TO BE IN NEED, THERE'S
GENERALLY THIS IS SIMILAR TO THE
PROGRAM THAT WE PROPOSED,
ANTIVIRAL DRUG DISCOVERY, THE
AVID CENTERS WHICH WILL BE
AWARDED SOMETIME THIS YEAR, WE
ENVISION THAT THERE MIGHT BE
SHARE AND SHUTTERS, AND IND
ENABLING AND RESEARCH CENTERS
AND THEIR RESEARCH PROJECT.
AND WE ENVISION THAT ANY
CANDIDATE, AND LOOKED LIKE A
SUCCESSFUL CANDIDATE GOING
FORWARD INTO PHASE 1 THROUGH OUR
INFECT YOWZ DISEASE RESEARCH
CONSORTIUM WHICH IS ALREADY
FUNDED.
SO THAT WAS QUITE A BIT, MAYBE I
SHOULD SEE IF ANYBODY HAS ANY
QUESTIONS THAT THEY WOULD LIKE
TO PROPOSE OR ASK QUESTIONS OR
GIVE FEEDBACK.
IT SOUNDS LIKE WE DON'T NEED A
FORMAL VOTE ON THIS BUT WE'RE
HAPPY TO GET FEEDBACK ON THIS
PROPOSED INITIATIVE.
ANYTHING FROM THE AUDIENCE,
OTHERWISE I WILL CONTINUE TO
MOVE FORWARD--
>> EMILY?
>> YES?
>> I HAVE MAYBE 1 OR 2
QUESTIONS.
ONE, IT'S OBVIOUSLY VERY
EXCITING.
I WONDER WHETHER YOU HAVE GIVEN
ANY THOUGHT TO HOW 1 COULD
INVOLVE THIRD WORLD COUNTRIES OR
THE SOUTH IN THIS EFFORT FOR A
NEW PANDEMIC.
IF THERE'S A LESSON FROM COVID
HAS BEEN 1 LESSON IS, BOY WE'VE
REALLY EXCITEDDED--SUCCEEDED IN
VACCINE DEVELOPMENT VERY RAPIDLY
FROM THE PRIVATE SECTOR AND
PUBLIC SECTOR HERE IN THE U.S.,
BUT MUCH OF THE WORLD HAS GOTTEN
LEFT OUT.
IS THERE ANY THOUGHT TO A
MECHANISM TO, IN THIS NEW EFFORT
TO TRY TO PROSPECTIVELY INVOLVE
LESS DEVELOPED COUNTRIES IN SOME
WAY.
I'M NOT SURE I KNOW HOW TO DO
THAT, ANDLET SECOND THING IS,
ALSO THE PRIVATE SECTOR PLAYED A
BIG ROLE IN COVID.
AND THIS, LOOKS--IS THERE
ANY--IN THE INITIATIVE.
>> SO I THINK I WILL RESPOND TO
THE FIRST INVOLVING LOW AND
MIDDLE INCOME COUNTRIES
INVESTIGATORS IN THIS
INITIATIVE.
I THINK THERE CERTAINLY COULD BE
ROOM FOR THAT, I THINK WE'RE
TALKING ABOUT VIRUSES THAT MIGHT
FIRST ARISE FROM ZOONOTIC
RESERVOIRS THAT ARE OUTSIDE OF
OUR BORDERS THAT ARE EX-U.S. AND
CERTAINLY INVOLVING
INVESTIGATORS OUTSIDE OF THE
U.S. TO SHARE THEIR--WHAT
THEY'VE LEARNED, WHAT THEIR LABS
ARE DOING AND REAGENTS AND
SEQUENCES MIGHT LEAD TO
PRODUCTIVE COLLABORATIONS SO I
THINK THAT'S AN IMPORTANT
COMMENT.
THANK YOU FOR THAT.
YES, AND I THINK THAT ON SECOND
QUESTION WITH REGARD TO THE
INVOLVEMENT OF INDUSTRY, YOU
HAVE FOUND IT VERY USEFUL IN THE
PAST TO INCLUDE AND SOMETIMES IN
WRITING A FUNDING OPPORTUNITY
ANNOUNCEMENT TO MAKE INDUSTRY
COLLABORATION MANDATORY BUT THAT
ISN'T JUST BIG PHARMA.
THAT'S OFTEN SMALL BIOTECH OR
SOME OF THE NONPROFITS THAT HAVE
BEEN SPECIFICALLY FORMED TO, YOU
KNOW TO MOVE PRODUCTS FORWARD.
THAT MIGHT NOT HAVE HAD A STRONG
COMPELLING COMMERCIAL MARKET.
SO, YES, I TAKE YOUR POINT AT
BOTH OF THOSE AND BOTH OF THOSE
COULD BE GETTING INCORPORATED
SOMEHOW SHOULD THIS INITIATIVE
BE SUPPORTED, SHOULD WE EVER GET
AN ALLOCATION OF FUNDS TO
SUPPORT THIS INITIATIVE.
ARE THERE MORE COMMENTS FROM--
>> YEAH, EMIMPEDIMENTSY, I JUST
HAD A CLARIFICATION, THE FOCUS
OF THAT IS PREPAREDNESS, RIGHT
DISM.
>> CORRECT.
>> AND SO AS YOGI, BEARRA WOULD
SAY IT'S DIFFICULT TO MAKE
PREDICTIONS, ESPECIALLY ABOUT
THE FUTURE AND SO THE
BIODIVERSITY THAT'S OUT THERE
AND THE VARIANT STUFF WILL
INEVITABLY GOING TO HAPPEN AND
THIS MAY RELATE TO HARRY'S
QUESTION, IS THERE A THOUGHT TO
TRY TO LINK THIS TO MAYBE SOME
OF THE EPIDEMIOLOGICAL
CHARACTERIZATIONS THAT MIGHT BE
ONGOING IN OTHER WORDS, GET A
LEG UP ON--I RATHER THAN HAVING
INFRASTRUCTURE AND CAPABILITY
AVAILABLE TO HAVE AS EARLY AS
POSSIBLE KNOWLEDGE ABOUT WHAT
YOU WILL BE DIRECTING YOUR
EFFORTS AGAINST.
I DON'T KNOW IF THAT'S A PART
YOU'RE THINKING ABOUT OR JUST
NOT MAKING THAT PART OF THIS
CONCEPT.
>> YEAH, SO, YOU WOULD THINK
LIKE FORECASTING IS WHAT YOU'RE
SUGGESTING, I THINK?
>> WELL, THAT'S PRETTY DIFFICULT
BUT YOU KNOW YOUR COMMENT ABOUT
FLU FOR EXAMPLE AND YOU KNOW A
LOT OF INFECTIOUS DISEASES WHEN
THERE'S NO CONTROL MEASURES IN
PLACE AND THEN YOU GET THE
REBOUNDS AND SO SOME OF THE
REBOUNDS WE MIGHT BE ABLE TO GET
A LITTLE ADVANCED WARNING IF
YOU'RE PARTNERING PERHAPS WITH
THE EPIDEMIOLOGIST, I THINK
THAT'S WHAT I WANTED TO SAY.
>> YEAH, I THINK--I MEAN WE DO
ENVISION PRIMARILY LABORATORY
BASED RESEARCH ON VIRUSES AND
PRODUCT DEVELOPMENT AS BEING THE
MAIN THRUST OF THESE CENTERS BUT
CERTAINLY, YOU KNOW THE
EPIDEMIOLOGY THIS THESE DAYS AND
HOW VIRUSES ARE EVOLVING ENDS UP
BEING VERY IMPORTANT AND PERHAPS
IN KNOWING WHAT TO TEST NEXT IN
YOUR ANIMAL MODEL FOR EXAMPLE, I
MEAN WE'RE DOING THAT NOW WITH
CORONAVIRUS VALID AND RELIABLE
YABTS.
SO YEAH, THERE MIGHT BE
OPPORTUNITY TO INCORPORATE THAT
INTO THIS INITIATIVE AS WELL.
>> EMILY MAY I MAKE A QUICK
COMMENT?
NYES.
>> SO PART OF THIS
EPIDEMIOLOGICAL WORK IS GOING TO
BE DONE BY THE CREEDS THAT EMILY
SUGGESTED AND WE'RE PLANNING TO
MAKE SURE THAT THE CREEDS ARE IN
VERY CLOSE COLLABORATION AND
INCORPORATION WITH THESE NEW
CENTERS BECAUSE OF COURSE YOU
NEED BOTH ASPECTS, YOU NEED THE
BASIC BIOLOGY AND PROPER
DEVELOPMENT BUT YOU ALSO NEED TO
FIGURE OUT WAYS EMERGING AT THE
SAME TIME.
BUT WE HAVE A--YEAH, SO DECREASE
THE SPECIALIZED IN DOING EXACTLY
THAT.
SO WE HOPE TO PUT THESE GROUPS
TOGETHER, AGAIN IF WE ARE ABLE
TO AWARD THESE CENTERS.
>> OKAY, SO NOW WE DO HAVE
CONTRACTS THAT REALLY DO REQUIRE
VOTING IS,A PROVE WILLA.
CAN YOU MOVE ME TO THE
NEXT--YES.
SO I WILL PRESENT TO YOU 3
PROPOSED TOPICS THAT THE
DIVISION OF MICROBIOLOGY AND
INFECTIOUS DISEASES PUT FORWARD
AND THEN MY COLLEAGUE WILL DRIEB
2 THAT HIS OFFICE PUTTING
FORWARD.
THE FIRST IS ENTITLED ADAPTATION
ADAPTATION
OF CRISPR-BASED INVITRO
DIAGNOSTICS FOR RAPID DETECTION
OF SELECTED UCARIOTIC PATHOGENS.
THIS WOULD BE OVER OTHER
TROPICAL DISEASES, PATHOGENS
THAT THERE'S CURRENTLY
DIFFICULTY OR LACK OF GOOD FIELD
DEPLOYABLE ASSAYS THAT ARE
SENSITIVE AND SPECIFIC.
SO THIS WOULD APPLY TO
CRISPR-CAS TO DEVELOP NEW
ASSAYS.
NEXT SLIDE, PLEASE.
THE SECOND TOPIC IS MODULAR
SAMPLE FOR I INFIELD VIRAL
DISCOVERY, AND THE FOCUS HERE IS
TO IMPROVE SAMPLE PROCESSING IN
THE FIELD FOR SOME OF THESE HIGH
CONSEQUENCE PATHOGENS SUCH AS
FILO, P A RI, AND FLAVI-VIRUSES,
THESE INFIELD SAMPLING PROCESSES
WOULD STABILIZE THE EXTRACTED
SAMPLES FROM ANY--HOPEFULLY ANY
TYPE OF CLINICAL SAMPLE FOR
ALLOW FOR STORAGE AND FIELD
ENVIRONMENTS WHERE THERE MIGHT
NOT BE REFRIGERATION AND THERE
MIGHT NEED TO BE TRANSPORT PRIOR
TO THE DIAGNOSTIC ANALYSIS,
ACTUALLY BEING DONE.
IDEALLY THESE WOULD BE MODULAR
SYSTEMS AND ALLOW FOR HIGH
THROUGH PUT PROCESSING AND AND
WOULD BE ABLE TO IMPLEMENT
PROCESSING FOR THINGS
LABORATORIES WITH LARGE
PROCESSING OR CENTRIFUGES.
SO THAT'S NUMBER 2, AND OUR
THIRD TOPIC IS ENTITLED
ARTIFICIAL INTELLIGENCE TO
IMPROVE CLINICAL MICROSCOPY FOR
THE DIAGNOSIS OF INFECTIOUS
DISEASES AND THIS WOULD CALL FOR
PROPOSALS TO-DISMF AND A LOT OF
THINGS, AFB SMEARS ARE DONE BY
TECHNICIANS SO TRAINING AND
HUMAN FATIGUE, LIMITS SOMETIMES
THE ABILITY TO PERFORM THESE
STUDIES WELL.
BUT WE PROPOSE THAT SCANNING AN
ARTIFICIAL INTELLIGENT SYSTEMS
COULD IMPROVE BOTH SENSITIVITY
AND MAYBE THE SPECIFICITY OF
IDENTIFYING TB AND SPUTUM FOR
EXAMPLE OR MALARIA ON A BLOOD
SMEAR OR SOME SORTS OF OPEN
PARASITES ON STOOL SMEARS.
SO THE PURPOSE OF THIS WOULD BE
TO DEVELOP AI APPLICATIONS TO
IMPROVE CLINICAL MICROSCOPY.
NEXT SLIDE, PLEASE.
SO NOW I'M GOING TO INTRODUCE MY
COLLEAGUE DR. WILBERT VAN P A
NHOUSE, WHO JOINED US AS THIS
LAST YEAR AND HE WILL PRESENT
THE NEXT 2 SBIR CONTRACT TOPICS.
WILBER, ARE YOU HERE?
>> THANKS, EMILY.
YES.
GO TO THE NEXT SLIDE, PLEASE.
YEAH.
SO OUR OFFICE WAS LOOKING AT
TOPICS THAT SPAN THE ENTIRE
NIAID INTEREST AREA AROUND DATA
SCIENCE, SO THESE ARE NOT
DIVISION SPECIFIC BUT WE'RE
GRATEFUL TO EMILY AND FOR THE
COUNCIL HERE TO LOOK AT THEM.
THESE BOTH ARE ABOUT
TECHNOLOGIES AND SOFTWARE FOR
DATA SCIENCE.
THE FIRST 1 IS ABOUT ADVANCE AND
IMMERSIVE VISUALIZATION TOOLS
FOR DISEASE RESEARCH.
THIS ADDRESSES THE AMOUNT AND
COMPLEXITY OF BIOMEDICAL DATA
THAT IS GROWING.
THE INCREASING NEED FOR NEW DATA
VISUALIZATION TOOLS THAT WILL
ENABLE RESEARCHERS TO EXPLORE,
UNDERSTAND AND COMMUNICATION
COMPLEX DATA, ESPECIALLY ACROSS
MULTIPLE SOURCES AND PLATFORMS
AND THE PURPOSE IS TO SUPPORT
DEVELOPMENT, ENHANCEMENT OR
ADAPTATION, OFF VISUALIZATION
TOOLS, SPECIALLY IMMERSIVE 3D
VISUALIZATION TOOLS, COMBINED
WITH MACHINE LEARNING ALGORITHMS
TO ACCELERATE RESEARCH DATA
ANALYSIS ACROSS INFECTIOUS AND
IMMUNE-MEDIATED DISEASES.
THE NEXT SLIDE, PLEASE.
THE SECOND TOPIC IS A BROAD
TOPIC THAT'S A CONTINUATION OF
LAST YEAR AS WELL, THAT INCLUDES
DATA SCIENCE TOOLS FOR INFECT,
MEDIATED DISEASE RESEARCH,
SIGNIFICANCE IS THAT REALLY TO
OPTIMALLY LEVERAGE POTENTIAL
AVAILABLE DATA FOR BIOMEDICAL
RESEARCH AND DISCOVERY, NEW
COMPUTATIONAL TOOLS ARE NEEDED
FOR FINDING DATA, CURATING DATA,
INTEGRATING DATA,ANALIZING
SHARINGING THAT DATA AND THE
PURPOSES IS REALLY ACROSS THE
BOARD TO SUPPORT DEVELOPMENT AND
ENHANCEMENT OF TOOLS, SOFTWARE
WORK FLOWS, DATA MODELS,
DATABASE MODELS, ET CETERA THAT
CAN BE READILY USED BY
RESEARCHERS TO FIND AND USE DATA
MORE EFFECTIVELY FOR THEIR
RESEARCH ON INFECT RELATED
DISEASES.
AND THERE ARE A VARIETY OF
INTEREST AREAS THAT ARE
SPECIFIED IN TOPIC DESCRIPTION
BUT THEY REALLY GO ACROSS ALL
THE WAY TO FINDING AND
DISCOVERING AND USING TO SHARING
DATA.
>> THANK YOU RNLINGS ANY
QUESTIONS FOR THE SWIL
CONTRACTS.
HARRY DO YOU HAVE YOUR HAND
RAISED?
>> YEAH, I KNOW I'M HERE HERE AT
STANFORD AND OTHER INSTITUTIONS,
ESPECIALLY WITH MACHINE
LEARNING, ENHANCED ABILITY TO
MAKE DIAGNOSIS FROM VISUAL DATA
SUCH AS X-RAYS OR SLIDES, THAT
TYPE OF THING, THE KEY TO THOSE
ARE LARGE QUANTITIES OF PAST
MATERIAL THAT HAS BEEN LOOKED AT
BY SO CALLED KNOWLEDGEABLE
PEOPLE THAT YOU CAN USE TO TEACH
THE MACHINE LEARNING.
AND I'M JUST THINK BEING IT FOR
ALL YOUR MICROBIAL DIAGNOSIS, I
DON'T KNOW WHERE THOSE EXIST.
I KNOW MUCH LESS ABOUT THAT BUT
IT WOULD BEIGATE IF YOU WERE
GOING TO DO THESE THINGS TO
BEGIN TO FIND VALIDATED LEARNING
SETS THAT YOU CAN USE FOR REALLY
SMART PEOPLE WHO MAKE THESE
THINGS.
>> YEAH, I AGREE, CAN TAKE--I
HAVE PERSPECTIVE TO IT BUT
THERE'S A LOT OF WORK IN
THINKING ABOUT KNOWLEDGE AND
DATABASES FOR THESE TYPES OF
DATA AND IT'S WELL UNDERSTOOD
THE NEED FOR CASTING AND THE
LACK OF THEM NOW AND HOW TO
SUPPORT THAT IS A BIG QUESTION
BUT THERE ARE DEFINITELY VARIOUS
EFFORTS ONGOING AND WE HAVE SOME
FOLLOW US OUT ON KNOWLEDGE BASED
DATABASE GENERATION AS WELL.
BUT THESE SBIR TOPICS THAT I WAS
TALKING ABOUT ARE MOSTLY
OBVIOUSLY TO BUILD THE TOOLS ON
TOP OF THESE THINGS, BUT
DEFINITELY WORTH--DEFINITELY
RECOGNIZE THE POINT YOU ARE
MAKING.
>> YEAH, I THINK THAT WE'LL SEE
WHAT COMES IN AND WE WILL SEE
WHAT HURDLES THEY FACE IN PEER
REVIEW AND IF WE NEED TO, YOU
KNOW GO BACK BECAUSE
THE--BECAUSE THE DATA FEED IS
INSUFFICIENT.
WE WILL HAVE TO THINK ABOUT HOW
TO ADDRESS THAT PROBLEM.
OKAY, SO I THINK THAT CONCLUDES
THE DIRECTOR'S REMARKS.
REMEMBER THAT WE DO NEED VOTES
AND I THINK THERE'S ALSO A TEXT
FIELD FOR COMMENTS.
WE WILL NEED VOTES ON EACH OF
THESE PROPOSED TOPICS FROM THE
SUBCOUNCIL MEMBERS.
AND OUR NEXT SPEAKER IS DR. LEAH
VINCENT WHO'S PROGRAM STAFF AND
ESTID AND SHE WILL PRESENT TO
YOU A CONCEPT FOR CLEARANCE.
LEAH?
>> THANK YOU.
GOOD AFTERNOON.
I'M DR. LEAH VINCENT, PROGRAM
OFFICER WITHIN THE DIVISION OF
MICROBIOLOGY AND INFECTIOUS
DISEASES.
THANK YOU FOR HAVING ME TODAY TO
SPEAK WITH YOU ABOUT OUR
PROPOSED INITIATIVE,
UNDERSTANDING THE CLINICAL
HISTORY OF BACTERIAL STI TO
ACCELERATE DIAGNOSTIC AND
VACCINE DEVELOPMENT.
THE OBJECTIVE IS TO SUPPORT
STUDIES ON THE CLINICAL STORY OF
SYPHILIS, GONORRHEA, CHLAMYDIA
WITH THE GOAL OF ACCELLING
DIAGNOSTIC AND VACCINE
DEVELOPMENT.
THIS IS A NEW INIAATIVE WITH AN
RO1 MECHANISM, WE ANTICIPATE 3-6
AWARDS AND THE FIRST YEAR TOTAL
COST FOR THE INITIATIVE IS
$3.6 MILLION.
CUC ESTIMATES HAVE SHOWN THAT
STIs ARE SURGED FOR THE FIFTH
STRAIGHT YEAR, NOT ONLY FOR
SYPHILIS BUT ALSO GONORRHEA AND
CHLAMYDIA.
THE W. H. O. STI VACCINE WROTE
THAT PUBLISHED JOINTLY WITH
NIAID IN 2013 ADENTIFIED
VACCINES FOR GONORRHEA SYPHILIS
AND CHLAMYDIA AS CRITICAL TOOLS
FOR RESPONDING TO THE STI
EPIDEMICS.
SINCE 2013 WHEN THE STI ROADMAP
WAS PUBLISHED, NIAID HAS
SUPPORTED 3 WORKSHOPS FOR STI
DEVELOPMENT, FOR GONORRHEA,
CHLAMYDIA, SYPHILIS IN THE
ROADMAP AS WELL AS ALL 4
WORKSHOPS, LACK OF KNOWLEDGE OF
CLINICAL HISTORY OF INFECTION
WAS CITED AS VACCINE DEVELOPMENT
AND BETTER DIAGNOSTICS FOR
CONTROL IN PARTICULAR IN GENERAL
FOR SYPHILIS.
IN 2021, THE NIAID WORKED WITH
OTHER FEDERAL AGENCIES TO
DEVELOP, IS TI NATIONAL STRAY
JECTORY STIGIC PLAN.
THIS PROPOSED INITIATIVE
ADDRESSES THE NATIONAL PLAN TO
ACCELERATE PROGRESS IN STI
RESEARCH AND TECHNOLOGY AND
INFORMATION BY FILLING THE GAP
THAT'S HINDERING VEHICLE SEEN
AND I DID AG NOOF THETIC
DEVELOPMENT.
--DIAGNOSTIC DEVELOPMENT.
THERE WE GO.
IN 2019 WE RELEASED A PROGRAM
ANNOUNCEMENT TO GAUGE INTEREST
AND DETERMINE IF INVESTIGATORS
COULD SUCCESSFULLY WORK.
TWO APPLICATIONS WERE
SUCCESSFULLY FUNDED WHICH IS A
LOWER SUCCESS RATE THAN THE
LOWER OVERALL NIH SUCCESS RATE,
BOTH OF THESE STUDIES IN
SLIGHTLY DIFFERENT WAYS ARE
TAKING ADVANTAGE OF SMALL
WINDOWS BEFORE TREATMENT TO
STUDY SPONTANEOUS CLEARANCE AND
OTHER ASPECTS OF CHLAMYDIA
INFECTION, SO BASED ON THE
INTEREST WE SAW IN THE SUCK SEZ
OF THE PA, THIS INITIATIVE WOULD
CONTINUE TO ADVANCE OUR
KNOWLEDGE WITH THE HISTORY
STUDIES FOR BACTERIAL STIs.
THIS INITIATIVE COULD HELP
BRIDGE THE GAP FOR STIs WHEN
IT COMES TO UNDERSTANDING THE
CLINICAL HISTORY OF DISEASE
AND--CLINICAL STUDIES WERE WELL
DOCUMMED IN THE EXISTING STI
RESEARCH PORTFOLIO, STI RESEARCH
CENTERS ARE FUNDED TO SUPPORT
VACCINE DEVELOPMENT BUT IMPROVED
UNDERSTANDING OF CLINICAL
HISTORY OF BACTERIAL STIs THAT
WILL ONLY COMPLEMENT THIS
EFFORT.
SO A DEDICATED STUDY SECTION
WITH BASIC STI AND EPIDEM
YOJICAL AND CLINICAL EXPERTISE
AND SET ASIDE FUNDING WILL BE
BENEFICIAL FOR THESE
APPLICATIONS.
THE SCOPE OF THE WORK OVERALL
WOULD BE RESEARCH TO HELP
ACCELERATE BETTER DIAGNOSTIC
DEVELOPMENT, ACCELERATE VACCINE
DEVELOPMENT AND RESEARCH TO
UNDERSTAND HUMAN IMMUNE RESPONSE
AFTER INFECTION THROUGH
DIAGNOSIS AND TREATMENT.
EFFORTS COULD INCLUDE THOSE
CERTAINLY NOT LIMITED TO
CLINICAL HISTORY OF GENITAL
INFECTION TO UNDERSTAND THE
BETTER COMPLEXITY OF MAT
TERNAL-FETAL INFECTION, FOR
CHLAMYDIA PERHAPS EXPLORING
PATHOGENESIS AND BIOMARKERS THAT
LED TO LONG-TERM PUBLIC
INFLAMMATORY DISEASE, THESE ARE
NOT AN EXOFF THIVE LIST BUT
RATHER--NOT AN EXHAUSTIVE LIST
BUT RATHER EXAMPLES.
I WOULD LIKE TO THANK THE 2
DOCTORS WHO REVIEWED THIS
CONCEPT WITH ME.
WE TALKED ABOUT A LOT OF THINGS
DURING OUR DISCUSSION BUT THESE
2 PIECES OF FEEDBACK HERE WERE
CRITICAL TO THE APPROVAL OF THE
CONCEPT.
THE DOCTORS WERE PARTICULARLY
HELPFUL FOR PUTTING THIS INTO
THE CONCEPT OF IMMEDIATEERN
TIMES.
WITH WE SPOKE, THE DOCTOR SAID
USING NATURAL HISTORY PUT HER
OFF, WE NEED TO FIGURE OUT
BETTER LANGUAGE.
BOTH SUGGESTED A CHANGE OF TITLE
TO REFLECT THIS WHICH WE CHANGED
FROM NATURAL HISTORY TO CLINICAL
HISTORY.
IT'S ALREADY A CHALLENGE IN
THESE STUDIES FOR BACTERIAL
STIs, WE'VE SEEN MORE NATURAL
HISTORY STUDIES OF SOME VIRAL
INFECTIONS, PARTICULARLY THOSE
FOR WHICH THERE'S NO AVAILABLE
TREATMENT AND THEREFORE PEOPLE
ARE OBSERVED AND FOLLOWED AFTER
INFECTION, HOWEVER IN THE
CONTEXT OF A CURABLE BACTERIAL
INFECTION, NATURAL HISTORY
STUDIES BECOME MUCH MORE
CHALLENGING BECAUSE YOU CAN'T
LEAVE THOSE INFECTIONS
UNTREATED.
FURTHER WHAT MAY COME TO MIND
WHEN PEOPLE THINK OF NATURAL
HISTORY STUDIES OR STIs ARE
STUDIES DONE IN THE PAST THAT
WERE CONTINUED BEYOND THE POINT
WHERE TREATMENT WAS AVAILABLE.
HOWEVER THERE IS A FRAMEWORK
TODAY TO PROPOSE STUDIES THAT
ETHICALLY ADDRESS THESE CRITICAL
RESEARCH QUESTIONS AND GAPS
WHILE PROTECTING FULL
PARTICIPANTS.
SO AFTER LENGTHY DISCUSSION WE
CAME UP WITH THE TERM CLINICAL
VERSUS HISTORICAL HISTORY,
NATURAL HISTORY COVERS
SCREENING, BUT ALSO SCREENING
AND DIAGNOSTIC--DIAGNOSIS
THROUGH TREATMENT AND FOLLOW UP.
THE OBJECTIVE WAS PRESENT A FULL
CLINICAL PICTURE OF WHAT HAPPENS
FOR THESE INFECTIONS IN THE
CONTEXT OF A CURABLE DISEASE
EMPLOY GIVEN THESE CONTEMPORARY
STANDARDS FOR THIS STUDY, THIS
REQUIRES INNOVATIVE APPROACHES
FOR STUDY DESIGN WHICH WE LOOK
FORWARD TO SEEING IN
APPLICATIONS ADDRESSING THIS
SCIENTIFIC GAP.
ADDITIONALLY IT WAS NOTED THAT A
DEDICATED CONCEPT WITH A
SPECIFIC POOL OF VIEWERS, STI
EXPERTS, EPIDEMIOLOGICAL EXPERTS
AND PEOPLEATOLOGICAL EXPERTS,
THE FEEDBACK WAS VERY THOUGHTFUL
AND HELPFUL IN ADDRESSING THE
LANGUAGE AND COB SEPTORSS AROUND
THESE CITIES AND I DO APPRECIATE
THE INDEPTH CONVERSATIONS I WAS
ABLE TO HAVE WITH BOTH.
AND THAT TAKES ME BACK TO THE
OVERALL OBJECTIVE AND I AM HAPPY
TO TAKE ANYY REQUESTS AT THIS
TIME.
>> DR. TAYLOR, I SEE YOU ON
MUTE.
>> WORKING WITH THE LANGUAGE WE
DID TALK QUITE EXTENSIVELY ABOUT
THAT BECAUSE PEOPLE WILL SEE
NATURAL HISTORY AND JUST STOP
RIGHT THERE.
AND SO THE EXAMPLES OF PLACES
THAT HAD NATURAL HISTORY WERE
NATURAL HISTORY OF CONGENITAL
SYPHILIS, NATURAL HISTORY OF
PATHOGENESIS, AND ITEMS THAT
LEAD TO COMPLICATION SAYS AND
CELL QUELLA LIKE CHLAMYDIA AND
GONORRHEA SO IT WAS REALLY GREAT
TO WORK THROUGH THAT BECAUSE THE
CONTEXT IN WHICH NATURAL HISTORY
WAS BEING USED WAS ACTUALLY
GOOD, OR FINE BUT YOU HAD TO
REALLY DIG DEEP INTO THE
EXPLANATION TO FIND OUT WHAT WAS
MEANT IN THE CONTEMPORARY
CONTEXT ABOUT NATURAL HISTORY.
SO I JUST REALLY WANT TO THANK
LEAH FOR WORKING THAT OUT AND
FOR BEING FLEXIBLE ENOUGH TO
CHANGE SOME OF THESE THINGS THAT
REALLY COULD BE MISCONSTRUED.
SO THANKS A LOT LEAH.
>> YEAH.
>> I ALSO WANT TO THANK LEAH AND
ALSO STEPHANIE FOR GIVING THAT
INSIGHTFUL FEEDBACK BUT ALSO I
WANT TO EMPHASIZE AGAIN THAT 1
OF THE SUBJECTS OF OUR
DISCUSSION WAS LIKE, DO WE NEED
TO MAKE SURE THAT THE STUDY
SECTIONS COMBINE FOR DIFFERENT
EXPERTISE NEEDED FOR THIS, I
THINK THAT MIGHT BE MISS NOTHING
SOME OF THESE MAYBE, THAT'S WHY
THERE WERE ONLY 2 PREVIOUSLY
FUNDED APPLICATIONS JUST TO MAKE
SURE THAT THERE IS A STRONG
EPIDEMIOLOGY, CLINICAL AS WELL
AS THE--YOU KNOW THE BASIC
SCIENCE, THE VIEWERS BECAUSE I
THINK THAT COULD HAVE ACTUALLY
IMPROVED THE SUCCESS OF THESE
APPLICATIONS.
YEAH.
>> THANK YOU.
>> OKAY, THANKS TO ALL.
THANK YOU LEAH, AND I THINK WE
CAN GO ON, IF THERE AREN'T ANY
FURTHER QUESTIONS OR DISCUSSION
POINTS WE CAN GO ON TO THE NEXT
CONCEPT FOR PRESENTATION.
DR. SAM PERDUE, BACTERIAL
ONCOLOGY BRANCH WILL TALK ABOUT
UNDERSTANDING LONG-TERM SEQUEL A
IN LYME DISEASE.
>> THANK YOU.
I WILL CHECK TO SEE IF I HAVE
CONTROL.
START MY VIDEO.
HOST HAS ASKED.
WELL, I'M HITTING MY ARROW AND--
>> PUT IT ON PRESENTATION AGAIN.
>> CLICK ON THE PRESENTATION
AGAIN.
>> THERE WE GO AND I CAN GO BACK
AND FORWARD.
THANK YOU VERY MUCH.
SO GOOD AFTERNOON, EVERYBODY,
I'M THE PERSON LISTED HERE, I'M
SAM PERDUE, SECTION CHIEF FOR
BASIC SCIENCES AND
BACTERIAEROLOGY IN MY ONCOLOGY
BRANCH AND THIS AFTERNOON I WILL
TALK A BIT ABOUT AN ISSUE THAT
WAS CONTROVERSIAL AND OFTEN
DOMINATED LYME DISEASE
DISCUSSION WHEN IS I JOINED
NIAID MORE THAN 20 YEARS AGO AND
IT REALLY HASN'T CHANGED MUCH
HERE IN 2022 AND THAT IS THE
ISSUE OF PERSISTENT SYMPTOMS
THAT HAVE BEEN ATTRIBUTED TO
LYME DISEASE, SOMETIMES WITHIN
THE MOTIER SPECIFIC PROPOSED
ETIOLOGIC FRAMEWORK OF CHRONIC
LIVE DISEASE.
WHICH PRESUMES THERE IS A
PERSISTENT POST ANTIBIOTIC
INFECTION.
SO THIS IS AN ISSUE WE THOUGHT
ABOUT A LOT.
WE'VE CONSIDERED INITIATIVES ON
THIS MANY TIMES OVER THE YEARS
AND WE FINALLY DECIDED THAT THIS
IS SOMETHING THAT'S PROBABLY
GOING TO REQUIRE A MULTIPRONGED
APPROACH BUT 1 OF THOSE PRONGS
WOULD BE A TARGETED RESEARCH.
THIS WOULD BE UNDERSTANDING THE
LONG-TERM LINGERING AND SYMPTOMS
OF WITH ACUTE LYME DISEASE
DISTION DIAGNOSIS.
THESE HAVE OFTEN BEEN
SPECIFICALLY MORE LABELED AS STL
OR POST TREATMENT LYME DISEASE,
BUT REGARD WILL OF WHAT YOU CALL
IT, THAT WILL BE THE NATURE OF
WHAT I DESCRIBE HERE.
NOW AS YOU MAY BE AWARE, THERE
HAVE BEEN ELEVATED
CONGRESSIONAL, THERE'S BEEN
ELEVATED CONGRESSIONAL INTEREST
TO A COMPANY OF A VERY CONSIST
AND THEN THE PERSISTENT ADVOCACY
INTEREST IN LYME DISEASE
SPECIFICALLY AND IN OTHER
TICK-BORNE DISEASES, AND FOR THE
SAKE OF TIME I WILL NOT GO
THROUGH EVERYTHING WE'VE DONE
BUT SUFFICE IT TO SAY WE
CONTINUE TO BE AND ARE ACTIVELY
ENGAGED IN MULTIPLE ACTIVITIES
ESPECIALLY OVER THE PAST 5 YEARS
WHETHER THEY BE ADVISORY
COMMITTEES OR STRATEGIC
PLANNINGS OR D.O.D.
COLLABORATIONS OR WORKING GROUPS
AND MANY OF THOSE IF NOT MOST OF
THEM HAVE STEMMED FROM THE 2
PIECES OF LEGISLATION THAT ARE
LISTED AT THE TOP AND THE BOTTOM
OF THE SLIDE.
AND IN EACH OF THOSE THE ISSUE
WAS ATTRIBUTED TO LYME DISEASE
AND THEIR TREATMENT HAS
GENERATED A CONSIDERABLE AMOUNT
OF ATTENTION.
SO JUST AS BACKGROUND, I THINK
MOST OF YOU ARE PROBABLY AWARE
OF THIS, BUT LYME--IT'S CAUSED
BY THE BLACK LEGGED TICK SHOWN
IN THE SLIDES TO THE RIGHT OR
LEFT WHICH SHOWS WE WERE
TRANSMITTED BY THE TICK RATHER
SHOWN ON THE RIGHT OR THE LEFT
AND CAUSED BY THE BACTERIA
[INDISCERNIBLE] SO WHEN YOU LOOK
AT LYME DISEASE THERE ARE SOME
CLASSIC SYMPTOMS, HEADACHE,
FATIGUE, FEVER, THE CLASSIC
RASH, AND THIS DOES NOT ALWAYS
LOOK LIKE A BULLS EYE, THERE ARE
KNOWN EXTRA CUTANEOUS EXTRA
SYMPTOMS THAT ARE--SUCH AS
CARDITEIS, MENINGITIS,
NEUROLOGICAL COMPLICATIONS AND
ARTHRITIS AND ABOUT 10% OF
PATIENTS WITH LYME ARTHRITIS MAY
HAVE A PERSISTENT ARTHRITIS
AFTER TREATMENT THAT IS
RESPONSIVE TO SOME OF THE
MEDICATIONS USED FOR AUTOIMMUNE
ARTHRITIS.
NOW DEPENDING ON WHEN YOU LOOK
AT THE LITERATURE, YOU WILL SEE
THAT APPROXIMATELY, OR IT'S BEEN
REPORTED THAT APPROXIMATELY
10-20% OF PEOPLE WITH ACUTE LYME
DISEASE CONTINUE TO HAVE
SYMPTOMS AFTER THE STANDARD
TREATMENT OF DOXYCYCLINE AND
THAT'S BEEN DETERMINED AS I
MENTIONED POST TREATMENT LYME
DISEASE.
ALSO HAVE WITH COMPLIAICATES
THINGS A BIT MANY SIGNS AND
SYMPTOMS THAT AFFECT MULTIPLE
ORGANS AND SYSTEMS THAT ARE
POPULARLY ATTRIBUTED TO CHRONIC
LYME DISEASE, SO THE PURPOSE OF
THIS INITIATIVE IS TO GET AT
SOME OF WHAT IS GOING ON HERE.
SO FOR TREATMENT, YOU HAVE GOT
MOST CASES RESOLVED WITH ORAL
DOXYCYCLINE OR WITH IV
SETRIPSYCHE LYNN WHEN IT IS
INDICATED AND 1 THING THAT HAS
BEEN CENTRAL TO ALL OF THIS
BECAUSE WITH WITHIN THE CHRONIC
LYME DISEASE ARGUMENT I'VE
MENTIONED, THERE'S BEEN
DISCUSSION THAT PATIENTS PEDE
EXTENDED LONG-TERM INTRAVENOUS
ANTIBI POTTICS, THERE ARE 5
CLINICAL TRIALS, SOME BY NIH,
SOME IN EUROPE THAT HAVE
DEMONSTRATED THAT LONG-TERM
INTRAVENOUS ANTIBIOTICS DO NOT
IMPROVE OUTCOMES AND IF THERE'S
BEEN A TRANSIENT IMPROVEMENT, IT
IS OUTWEIGHED BY THE LEVEL OF
RISK.
I SHOULD ALSO POINT OUT THAT
HOWEVER, WHEN YOU LOOK AT
PARTICULARLY THE [INDISCERNIBLE]
PAPER, THE FIRST STUDY THAT WAS
DONE, AND THEY RECRUITED
PATIENTS WHO HAD DISABILITY
AFTER A CLEAR UNEQUIVOCAL LYME
DISEASE DIAGNOSIS, THEY HAD
SUBSTANTIAL LEVELS OF
DISABILITY.
SO THIS IS NOT AN IMAGINARY
THING, PEOPLE ARE TRULY SICK AND
TRULY, TRULY ILIN SOME CASES
AFTER HAVING AN INITIAL DOSE OF
LYME DISEASE FOR PRIMARY
TREATMENT.
SO WHAT WE HAVE IS THIS KIND
OF--THIS IS THE SITUATION WHERE
WE ARE TODAY.
WE HAVE PEOPLE WITH KNOWN
UNEQUIVOCAL LYME DISEASE.
THEY'RE TREATED, MOST DO OKAY,
BUT SOME HAVE PERSISTENT
SYMPTOMS.
YOU ALSO HAVE ANOTHER GROUP THAT
HAS UNKNOWN SYMPTOMS, THEY MAY
NOT MEET THE KIND OF STANDARD 3
TEAR CRITERIA FOR LYME DISEASE
OR THE EM RASH BUT NEVERTHELESS
VISIT BEEN DIAGNOSED AS LYME
DISEASE JUST THROUGH PHYSICIAN
ASSESSMENT OR WHO HAVE
SELF-DIAGNOSED IN LYME DISEASE
IN SOME CASES AND THEY HAD THIS
COLLECTION OF PERSISTENT
SYMPTOMS WHICH IS CALLED
LONG-TERM LYME DISEASE WHICH
NEEDS EABT BIOTICSS, AND IF YOU
DON'T SUPPORT LONG-TERM
ANTIBIOTICS THEN THEREFORE THAT
YOU ARE NOT SUPPORTIVE OF
PERSISTENT SYMPTOMS OF LYME
DISEASE.
AND SO WE WERE GOING TO TACKLE
THIS AND 1 WAY IS THROUGH THIS
INITIATIVE AND LOOK AT PEOPLE
WITH PERSISTENT SYMPTOMS THAT
ARE KNOWN TO BE TEMPORARILY
ASSOCIATE WIDE AN KRARKS CUTE
LYME DISEASE DIAGNOSIS AND POST
TREATMENT LYME DISEASE SYNDROME.
AND THEN DETERMINE WHAT IS
CAUSING THAT AND FROM THAT
DETERMINE WHAT THE MOST
EFFECTIVE APPROACH TO DIAGNOSIS
AND TREATMENT ARE.
WE ARE NOT IN ANY WAY DISMISSING
LONG-TERM ANTIBIOTICS IN SOME
CASES THAT IS THE MOST EFFECTIVE
DIAGNOSIS AND TREATMENT BUT WE
WANT TO SEE WHAT IS GOING ON.
IS IT 1 THING, MULTIPLE THINGS,
SO FORTH.
SO IF YOU LOOK AT OUR CURRENT
PORTFOLIO, WE DO NOT HAVE A LOT
IN THE ISSUE OF PERSISTENCE OR
PERSISTENT SYMPTOMS.
WE HAVE A FAIR AMOUNT IN LYME
ARTHRITIS.
IF YOU LOOK AT THE LYME
COMMUNITY, THEY SEE LYME
ARTHRITIS AS A SEPARATE THING,
MOST OF THEM ARE SUFFERING FROM,
AND THEY'RE REALLY INTERESTED,
AND THIS GOES TO CONGRESS AS
WELL, REALLY INTERESTED MORE IN
THE GENERAL CAUSES OF-- SYMPTOMS
FOR LYME DISEASE.
WE DIDN'T WANT TO DISMISS LYME
ARTHRITIS AND I PERSONALLY
BELIEVE THERE MAY BE THINGS WE
CAN LEARN WITH LYME ARTHRITIS TO
OTHER CONDITIONS, OTHER SIGNS
AND SYMPTOMS BUT WITHIN THE
FRAMEWORK OF WHY WE CAN'T
ADDRESS IT WITHIN OUR CURRENT
INIAATIVES OR CURRENT
ACTIVITIES, WE DON'T GET A
TREMENDOUS AMOUNT ON THIS AND
WHEN IT DOES GET TO PEER REVIEW,
IT DOES NOT DO PARTICULARLY
WELL, SO WE HAVE A RELATIVELY
SMALL PORTFOLIO.
SO WHEN YOU LOOK AT THESE
PERSISTENT SYMPTOMS ATTRIBUTED
TO LYME DISEASE AND I'LL TAKE A
STEP BACK AND LOOK AT THIS
TITLE.
WE'VE GONE BACK AND FORTH WITH
THE TITLE A BIT AND THIS IS SORT
OF THE TITLE WE'RE SIT NOTHING
RIGHT NOW AND LINDA MIGHT
ADDRESS THIS TOO, BUT LINDA AND
I TALKED ABOUT THIS AS WELL, YOU
COULD HAVE A PERSISTENT OR
CHRONIC INFECTION, PEAR HAPPENS
IN SOME CASES IT'S NOT A CLEAR,
NOT PERHAPS IT'S A CO-INFECTION
ISSUE, WHICH IS A POPULAR
PROPOSAL FOR WHAT IS CAUSING
CHRONIC ILLNESS, THERE ARE
PEOPLE THAT LOOKEDDA THE
AUTOIMMUNE RESPONSE, WE ARE
PEOPLE LOOKING AT INFLAMMATORY
RESPONSES, IT IS PROPOSED, IT IS
MORE OF A GENERAL POST INFECTION
SYNDROME, PERHAPS WE CAN LEARN
SOMETHING FROM COVID LONG
HAULERS IN THIS CASE, THAT IS
NOT SPECIFIC TO LYME BUT IT IS
VERY REAL IN TERMS OF RECOVERING
IN CERTAIN INFECTIONS TCAN BE
OTHER DISEASES AND THEN THE
FRAME, WITHIN ALL OF THESE
FRAMEWORKS THERE COULD BE
GENETIC DETERMINANTS TO THESE,
THERE COULD BE MICROBIOME
EFFECTS AND SO FORTH.
THAT WE WOULD NEED TO LOOK AT.
AND SO IN 2021 WE HAD A
WORKSHOP, AN INTERNAL WORKSHOP
WITH OUTSIDE INVESTIGATORS AND
INSIDE FOLKS WHO HAD DIFFERENT
PERSPECTIVES ON WHAT IS CAUSING
THIS FROM--THERE WERE SOME WHO
BELIEVED VERY MUCH IN PERSISTENT
INFECTION, SOME WHO DID NOT
BELIEVE IN PERSISTENT INFECTION,
AND ALL THE BUTLES TO THE LEFT
TO GET A HANDLE ON WHAT WAS
GOING ON AND THEN WE DECIDED TO
FOLLOW THAT UP WITH AN ACTUAL
RESEARCH INITIATIVE.
SO THE SCOPE OF SUPPORT FOR THIS
WILL BE RESEARCH ON MECHANISMS
OF PERSISTENT SIGNS AND SYMPTOMS
FOLLOWED BY--OR FOLLOWING A
DEFINED B.BURGDORFERI INFECTION,
IT WILL ALSO INCLUDE IDENTIFYING
MARKERS PREDISPOSING INDIVIDUALS
TO PERSISTENT SYMPTOMS WILL
FOLLOWING TREATMENT, THAT DOES
NOT MEAN THAT PEOPLE HAD A
PARTICULAR MECHANISM AND THEY
HAD A DRUG OR SMALL MOLECULE
THAT BLOCKS THAT, THAT THEY
CAN'T USE THAT TO SUPPORT THEIR
HYPOTHESIS, BUT IT'S
NONAPOPTOTIC A PROPOSAL TO
DEVELOP NEW DRUGS FOR TREATING
LYME DISEASE AT THIS STAGE.
AND WILL NOT SRMT AT THIS STAGE
CLINICAL TRIALS.
SO DR. STEWARD AND
DR. [INDISCERNIBLE] WERE MEMBERS
AND IT WAS INTERESTING TO TALK
TO THEM BECAUSE THEY GOT AT IT
FROM DIFFERENT PERSPECTIVES.
DR. STEWART HAD THE GLOBAL
PERSPECTIVE AND DR. BACKSTED HAD
THE PERSPECTIVE OF WORKING IN
THE LYME DEC COMMUNITY SO IT WAS
INTERESTING AND VALUABLE TO GET
BOTH PERSPECTIVES ON THIS.
THERE WAS OVERALL SUPPORT OF THE
OVERALL ARCHING NEED AND GOAL.
THERE WAS A VIEW OF POTENTIAL
APPLICABILITY TO OTHER
INFECTIOUS DISEASES, CERTAINLY
BOTH OF THEM MENTIONED WHAT
WE'RE LEARNING FROM COVID LAWNG
HAULERS MAY COME INTO PLAY.
DID HAVE A DISCUSSION ABOUT I
THINK MOST PARTICULARLY WITH
LINDA ABOUT UTILIZING HUMAN
CLINICAL SAMPLES VERSUS ANIMAL
SAMPLES WHEN POSSIBLE.
AND TO EXPAND ON THAT, 1 OF MY
CONCERNS IS THAT RESEARCH
INVESTIGATORS ARE INCREDIBLY
GOOD AT STATING THEIR RESEARCH
IS RELEVANT TO A SPECIFIC RFA,
AND WHAT WE WANT TO MAKE SURE IS
THAT WE'RE GETTING PROPOSALS
WHERE PEOPLE ARE CLEARLY LOOKING
AT SOMETHING THAT IS A KNOWN
PERSISTENT SYMPTOM AND THEY WORK
BACKWARDS FROM THERE, RATHER
THAN STARTING WITH WHATEVER
THEY'RE WORKING FOR AND SAYING,
WELL, THIS MIGHT BE RELEVANT TO
PERSISTENT SYMPTOMS, SO WE WANT
TO USE HUMAN CLINICAL SAMPLE
WHEN IS WE CAN BUT THAT'S NOT
GOING TO OBVIOUSLY DISMISS
ANIMAL MODELS BUT WE WANT TO
MAKE SURE THESE PROPOSALS ARE
TIED VERY CLEARLY TO PERSISTENT
SYMPTOMS.
AND ALSO THERE WAS DISCUSSION OF
WHAT'S GOING ON WITH THE
MICROBIOME EFFECT WHETHER IT'S
GENERAL OR IN RESPONSE TO
ANTIBIOTIC THERAPY FOR EXAMPLE,
THAT COULD BE LEADING TO THESE
SYMPTOMS.
AND THERE WERE OTHER THINGS THAT
WE TALKED ABOUT, MANY OF THEM
HAVE BEEN INCORPORATED WITHIN
THE SLIDES THAT I SHOWED YOU.
SO AGAIN, HERE IS THE CONCEPT.
WE ARE GOING TO SUPPORT RESEARCH
AND PATHOGENESIS PERSISTENT
SYMPTOMS ATTRIBUTED TO LYME
DISEASE AND MARKERS PREDICTING
DEVELOPMENT AND IF YOU HAVE ANY
QUESTIONS I AM HAPPY TO ANSWER
IT.
>> I SEE HARRY HAS HIS HAND
RAISED.
>> JUST OUT OF CURIOSITY BEFORE.
>> WE WOULD PROBABLY FIND IT AS
DOCUMENTED SERIES POINTSOLOGY OR
EM RASH, BECAUSE WE WANT TO MAKE
SURE WE HAVE A CLEAR UNEQUIVOCAL
DIAGNOSIS.
>> AND JUST OUT OF CURIOSITY,
WITH THAT DEFINITION, WHAT
PROPORTION OF DOCUMENTED LYME
INFECTIONS DO YOU THINK HAVE
LONG-TERM SEQUELACE?
>> IT'S GENERALLY REPORTED AS
10-20%.
>> THAT'S TREATED 10-20%.
>> OBVIOUSLY IF YOU'RE NOT
TREATED, THERE ARE PROBLEMS BUT
THAT'S A DIFFERENT QUESTION
THERE.
>> DO WE HAVE ANY OTHER COMMENTS
OR QUESTIONS FROM SOME COUNCIL
MEMBERS?
>> I JUST WANT TO SAY IN SUPPORT
OF SAM HERE THAT YOU KNOW THIS
IS A REALLY DIFFICULT AREA AND
FROM THE BEGINNING IN THE 1990S
AND CONNECTICUT PEOPLE WERE
DEVELOPING PERSISTENT SYMPTOMS,
SO, YOU KNOW IN THOSE DAYS,
OFFENSE TIMES IT WAS A
CONSIDERABLE DELAY IN THE
DIAGNOSIS, SO SOME OF THE
PERRISTENT ISSUES THEY HAD WERE
ACTUALLY CHRONIC TISSUE DAMAGE
FROM AN UNTREATED INFECTION.
YOU KNOW WE'VE SEEN MORE IN THE
LAST, I THINK, YOU KNOW 5-10
YEARS OR PEOPLE WHO HAVE BEEN
PURPOSELY DIAGNOSED AND TREATED
EARLY ON BUT IT TAKES THEM A
LONG TIME TO GET BACK TO NORMAL
OR WE FOLLOW THEM OUT FOR A YEAR
AND THEY'RE STILL NOT WHERE THEY
SHOULD BE AND SOMETIMES THEY
HAVE THESE REALLY DISABLING
SYMPTOMS, SO I THINK THERE
IS--THERE IS A SIGNAL THERE
THAT'S REAL.
THE PROBLEM WITH TRYING TO STUDY
IN AN ANIMAL MODEL AT ALL IS
THAT THESE ARE SUGGESTIVE
DYSFUNCTIONS THAT ARE IN
MUSCULOSKELETAL AND PAIN AND
FATIGUE, YOU KNOW UNLIKE OTHER
INFECTIONS, LIME DISEASE, THESE
TYPES OF BACTERIAL INFECTIONS AS
AN EXTRA CELLULAR BACTERIUM,
THIS ORGANISM IS LISTED, IT'S A
STRONG TYPE 1 INTERFERON
RESPONSE.
AND YOU DON'T SEE PUSS IN THE
LESIONS OF AN EM LESION, IT'S
NOT THE SAME AND SO, I THINK WE
CAN LEARN SOMETHING FROM OTHER
TYPE DISEASES THAT ARE MORE TYPE
1 ASSOCIATED KLF-TWO IS WHY I
THINK AT THIS POINT IN TIME WITH
THE ONGOING EFFORT, WITH LONG
COVID, YOU MIGHT FIND PARALLELS
YOU COULD ARK PLIE TO A POST
COVID TREATMENT THAT, A POST
LYME DISEASE--POST TREATMENT
LYME DISEASE SYNDROME THAT MIGHT
HAVE ARISE IN SOME PEOPLE.
>> YEAH, SO I WOULD LIKE TO JUST
JOIN IN AND THANK SAM FOR A
TERRIFIC PRESENTATION AND
APPRECIATED THE COMMENTS AND I
THINK YOU KNOW MY VIEW IS
CHARACTERIZED AS GLOBAL, I THINK
IT'S--THE ISSUE HERE IS WE CAN
HEAR ECHOES OF MANY OTHER
DISEASES, ISSUES THAT ARE
PHASING MANY OTHER DISEASES,
INCLUDING THE DEFINITION OF WHAT
IS THE CONDITION SPECIFICALLY AS
BEING UNDER INVESTIGATION AND
THIS MAY LEAD TO SOME OF THAT
DEFINITION IS THEN THE FURTHER
UNDERSTANDING OF WHAT'S SPECIFIC
TO LYME DISEASE VERSUS OTHER
DISEASES AND WHAT'S IN COMMON.
SO, I THINK THIS IS A REALLY
GREAT ADDITION.
>> THANK YOU.
ANY OTHER COMMENTS?
OKAY, THANK YOU SAM.
WE HAVE MOVING ON TO OUR NEXT
INITIATIVE, THE TITLE IS
PARTNERSHIPS FOR THE DEVELOPMENT
OF VACCINES AGAINST SELECT
BACTERIAL ENTERIC PATHOGENS.
AND DR. MELODY MILLS WILL GIVE
THE PRESENTATION.
ARE YOU THERE MELODY?
>> YES, I AM.
HI, EVERYONE.
THANK YOU FOR THE OPPORTUNITY TO
PRESENT THIS PARTICULAR
PARTNERSHIP THAT FOCUSES ON THE
DEVELOPMENT OF VACCINES AGAINST
SELECT ANTIMICROBIAL RESISTENT
ENTERIC PATHOGENS.
I AM A PROGRAM OFFICER, I AM
ALSO THE SECTION CHIEF OF THE
ENTERIC INFECTION SECTION IN THE
ENTERIC AND SEXUALLY TRANSMITTED
INFECTIONS BRANCH.
>> SO THE SINGULAR FOCUS OF THIS
OBJECTIVE IS TO ADVANCE ENTERIC
VACCINE CANDIDATES FURTHER ALONG
THE PRODUCT DEVELOPMENT
PIPELINE.
IT FOCUSES ON 3 GENRE OF FOOD
AND WATER BORN BACTERIAL
PATHOGENS THAT ARE ETEC WHICH
LOW AND MIDDLE INCOME COUNTRIES
CAUSINGS AN ACUTE INFANT
DIARRHEA AND NATIONALLY IN HIGH
INCOME COUNTRIES, INTERNATIONAL
TRAVELS DIE EVERY YEAR,
SHIGGELLA, THAT ARE MOST
RESPONSIBLE FOR THE SHIGELLA AND
SARA TYPE PARATYPHY A CAUSES
TYPHOID FEVER.
THERE'S ANOTHER ENTERIC FEVER,
THIS IS A NEW CONCEPT.
THE MECHANISM IS A MILESTONE
DRIVEN RO1 AND WE ANTICIPATE 5-7
AWARDS AND THE FIRST YEAR TOTAL
COST IS SHOWN ON THE SLIDE.
5.2 MILLION.
SO IN TERMS OF THE SCOPE OF
SUPPORT, A CRITICAL REQUIREMENT
FOR THIS PARTNERSHIP CONCEPT IS
HAVING LEAD VACCINE CANDIDATES
AVAILABLE.
THEY'RE READY FOR FURTHER
DEVELOPMENT TOWARDS CLINICAL
STUDIES AND TRIALS.
AREAS OF INTEREST MAY INCLUDE
REDESIGNING THE CONSTRUCTS,
BROADENING THE CANDIDATES BY
INCORPORATING ADDITIONAL
COMPONENTS SUCH AS SPECIFIC
ANTIGENS OR SEROTYPE SPECIFIC
COMPONENTS.
OPTIMIZING CONSTRUCT AND
POTENTIALLY GENERATING
VACCINATION VACCINES, THE WORK
PROPOSED CAN SPAN THE RANGE OF
TRANSLATIONAL ACTIVITIES BUT
CLINICAL TRIALS WOULD NOTED BE
ALLOWED.
THIS PARTNERSHIP WOULD TARGET
VACCINES APPLICABLE TO BOTH
DOMESTIC AND INTERNATIONAL
POPULATIONS.
AND 2 OVERARCHING UNMET UNMET
PARTNERSHIPS, FIRST DISCIPLINARY
REALIA ON ALL AGES PARTICULARLY
CHILDREN AND SECOND THE
ANTIBIOTIC RESISTANCE IN THESE
PATHOGENS PARTICULARLY
SALMONELLA AND SHIGELLYME
ARTHRITISA, SO THERE ARE
LONG-TERM IMPACTS TO
DISCIPLINARY REAL AT DISEASES
THAT CAN BE SUBSTANTIAL, THE
EPIDEMIOLOGY CAN BE A MOVING
TARGET AND THE SPECIFIC
PATHOGENS DOES NOT NECESSARILY
OVERLAP GEOGRAPHICALLY, SO
DISCIPLINARY REAL DISEASES ARE
THE EIGHTH LEADING CAUSE OF
DEATH FOR ALL AGES GLOBALLY AND
IT'S ESPECIALLY PROBLEMATIC FOR
THOSE OVER 70 YEARS OF AGE A
GROUP THAT HAS DECREASED BY 1990
AND 2016 IT'S THE FIFTH LEADING
CAUSE OF DEATH FOR CHILDREN
UNDER 5 YEARS OF AGE AND THEIR
DIARRHEA'LL DISEASE OF CHILDREN
YOU SHOULD 5 AGE IS ASSOCIATE
WIDE AN INCREASED RISK OF
MORTALITY FROM SUBSEQUENT
INFECTIOUS DISEASE AND IT'S
IMPORTANT TO NOTE THAT THE
BURDEN OF DIAREAL DISEASES IS
UNDER REPORTED.
REPORTED BURDEN VARIES BY
REGIONAL DIFFERENCES BETWEEN AND
WITHIN COUNTRIES BETWEEN RURAL
AND URBAN AREAS IN THE COUNTRY
AND OFTEN THE DATA WE HAVE
AVAILABLE COMES ONLY FROM A
SPECIFIC AREA WITHIN A
COINCIDENTRY OR REGION OF THE
COUNTRY.
BUT SHIGELLA AND ETECH REPRESENT
THE SECOND LEADING CAUSE OF
DEATH DUE TO DIARRHEA IN
CHILDREN UNDER 5 YEARS AGE.
220 MILLION CASES ANNUALLY AND
MORE THAN 250,000 DEATHS
ANNUALLY THEY REPRESENT THE
CAUSES OF ABOUT 20% OF GLOBAL
PORTALLITY DUE TO DIAREAL
DISEASE.
AND THE AREA WITH THE GREATEST
DISEASE BURDEN TYPICALLY HAVE
RELATIVELY HEALTHCARE STRUCTURE,
POOR DISEASE SURVEILLANCE AND
INADEQUATE LABORATORY CAPACITY
TO DETECT THESE PATHOGENS.
SALMONELLA PARATYPHOID FEVER A
IS A MAJOR CAUSE OF DISABILITY
AND DEATH.
THE DISABILITY PEEKS IN THE 5-9
YEARS OF AGE RANGE.
AND WE KNOW THAT THERE ARE
ONGOING OUTBREAKS OF PARATYPHOID
FEVER AT THIS POINT IN TIME IN
ASIA AND AFRICA.
SO THE LONG-TERM HEALTH IMPACTS
CAN BE PARTICULARLY DRAMATIC
ESPECIALLY DURING CHILDHOOD OR
INFANCY.
SO THIS CAN HAPPEN, THESE LIFE
LONG REPERCUSSIONS CAN OCCUR
BOTH WITHIN SYMPTOMATIC BUT ALSO
ASYMPTOMATIC INFECTIONS AND WE
DO SEE CHILDHOOD DEVELOPMENT
OCCURS WITH THESE INFECTIONS,
THIS INVOLVES, STUNTING,
NUTRITION, THAT CAN LEAD TO
COGNITIVE IMPAIRMENT, COGNITIVE
IMPAIRMENT DEVELOPMENT AND THAT
CAN NEGATIVELY IMPACT THE
INDIVIDUALS EDUCATION AND THEIR
LIFE LONG ECONOMIC POTENTIAL.
THERE ARE ALSO HARMFUL SEQUELAI
THAT CAN AFFECT ALL AGES OF THE
POPULATION, FOR EXAMPLE,
ENVIRONMENTAL ENTERIC
DYSFUNCTION OR EED WHICH WAS
PREVIOUSLY HISTORICALLY KNOWN AS
STROPICAL SPRUE, THIS IS TOOKLY
PROBLEMATIC FOR CHILDREN AND
CAUSES GROWTH FAILURE, IT CAUSES
GUT ENTEROPEN MEETINGATHY THAT
INVOLVES STRUCTURAL AND CHANGES
IN THE SMALL INTESTINE AND YOU
SEE OTHER DELETERIOUS
MANIFESTATION SUCH AS GUT
INFLAMMATION, DYSENTERY, BOWEL
DISORDERS SUCH AS IRRITABLE
BOWEL DISORDER OR INFLAMMATORY
BOWEL DISEASE AND THESE
PATHOGENS PROMOTE THESE DISEASES
THROUGH PERMANENT CHANGES IN THE
MICROBIAL OR MICROBI OTA BEING
TESTED, DISRUPGDZ OF BARRIER AND
ALTERED IMMUNE RESPONSES
FOLLOWING THE INFECTION,
SHIGELLA AND SALMONELLA
INFECTIONS HAVE LONG BEEN LINKED
TO AN ARTHRITIS SEQUELACE AS
REFERRED TO ARB, SO ANOTHER
ISSUE FOR ENTERIC PATHOGENS, THE
CDC 2013 AND 2019 EABT BIOTICS
RESISTANCE THREATS FOR THE U.S.,
CITED ESBL, AND SHIGELLA AS A
SERIOUS THREAT LEVEL, THE W. L.
O. PUBLISHED A PATHOGEN LIST FOR
RESEARCH AND DEVELOPMENT OF NEW
ANTIBIOTICS.
AND THEY IDENTIFIED THE MOST
IMPORTANT RESISTANT BACTERIA AT
A GLOBAL LEVEL.
SO SALMONELLA IS LISTED AS A
HIGH PRIORITY AND SHIGELLAWYERA
SPECIES ARE LISTED AS MEDIUM
PRIORITY.
BUT IN TOTAL THERE IS AN URGENT
NEED TO COMBAT MULTIRESISTANT
STRAINS OF THESE PATHOGENS AND
IN AS EARLY AS 2015 WE SAW
EXTREMELY DRUG-RESISTANT
SHIGELLOSIS IN THE U.S., SO
MULTIPLE MEETING IN THE LAST-10
YEARS WITH THE GLOBAL PARTNERS,
REPRESENTATIVES FROM OUR SISTER
AGENCIES AND LEADERS IN ACADEMIC
COMMUNITIES LED TO VIEW THAT
VACCINES ARE NEEDED FOR PRIMARY
PREVENTION OF DISEASE CAUSED BY
HIGH PRIMATES PORTY ENTERIC
BACTERIA AND ALTHOUGH THERE IS A
LONG HISTORY OF VACCINE RESEARCH
AND DEVELOPMENT FOR ENTERIC
PATHOGENS, NO LICENSE VACCINES
EXIST FOR THESE PARTICULAR BUGS.
AND INDEED, RECOGNITION OF THE
CRITICAL ROLE VACCINES WILL PLAY
IN PRIMARY DISEASE PREVENTION
ENERGIZE THE ACADEMIC AND
BUSINESS INTEREST, AND THE
TIMING OF THIS CONCEPT IS
PARTICULARLY HELPFUL BECAUSE IT
ALLOWS DEVELOPERS TO,A LIEN WITH
THE PUBLISHED W. H. O. PREFERRED
PRODUCT CHARACTERISTICS AND SO
THE ETEC PPC WAS PUBLISHED IN
AUGUST OF 2021, THE SHIGELLA,
PPC WAS PUBLISHED AT THE END OF
LAST NOVEMBER.
SO WE DO KNOW AS WELL THAT THERE
ARE MANY VACCINE CANDIDATES THAT
EXIST THAT CAN TAKE ADVANTAGE OF
THIS PARTNERSHIP.
SO DMID SUPPORTED RESEARCH AND
DEVELOPMENT FOR ALL 3 OF THESE
PATHOGENS, THROUGH VARIOUS
DIFFERENT MECHANISMS, VACCINE
CANDIDATES HAVE BEEN DEVELOPED
BY OTHER ACADEMIC INVESTIGATORS,
NONGOVERNMENTAL ORGANIZATIONS
AND THE PHARMACEUTICAL INDUSTRY
SO THE VARIETY OF CANDIDATES
HAVE BEEN GENERATED USING
DIFFERENT PLATFORMS AND
FORMULATIONS.
FOR INSTANCE WE HAVE BOTH LIVE
ORAL ATTENUATE VACCINES,
CONJUGATE CANDIDATES, JON JUGATE
VACCINE CANDIDATES WE SEE SINGLE
AND COMBINATION VACCINE
CONSTRUCTS AND 1 EXAMPLE OF A
NICE PLATFORM IS THE GENERALIZED
MODULES FOR MEMBRANE ANTIGENS
THAT USE OUTER MEMBRANE
VESICLINGS FROM ENGINEER GRAM
NEGATIVE BACTERIA AS CARRIERS
FOR RECOMBIN ANT PROTEINS AND
POLYSACCHARIDES SUCH AS THE
O-ANTIGEN.
SO I WANT TO THANK THE ADVISORY
COUNCIL MEMBERS, DOCTORS HARRY
GREEN BURG AND TIENER FOR THEIR
FEEDBACK, THEY WERE OVERALL
SUPPORTIVE.
DR. GREEN BERG WANTED TO KNOW IF
THERE WERE VACCINE CANDIDATES
AVAILABLE SO I ADDED MORE DETAIL
TO THE PRESENTATION ABOUT THAT,
HE DID COMMENT THAT THE POETIC
TEBTIAL MANUFACTURES MIGHT
BE--THEY MIGHT EXIST IN LOW AND
MIDDLE INCOME COUNTRIES.
C TYNER SAID THAT WAS HIS HOPES
AND THAT'S THE END OF MY
PRESENTATION AND I'M HAPPY TO
TAKE ANY QUESTIONS OR CONCERNS.
>> ANY ON COUNCIL HAVE A
QUESTION OR FEEDBACK FOR THIS
CONCEPT FOR MELODY?
GARY, I THINK YOU HAVE YOUR HAND
UP?
>> AS 1 OF THE REVIEWERS, PICKED
A LOT OF PATHOGENS THAT HAVE
BEEN AROUND FOR A LONG TIME AND
THEY HAVE ENDURED.
WE NEEDED A VACCINE 40 YEARS AGO
AND WE STILL NEED IT SO I
APPLAUD YOUR PERSISTENCE.
>> THANK YOU HARRY.
OTHERS?
OKAY.
>> I HAVE A QUESTION FOR MELODY
BECAUSE SHE MENTIONED YOU HAVE
TO HAVE A VAC SIGN PAT TONIGHT
IN ORDER TO APPLY THAT OR
SOMETHING LIKE THAT, OR ANYMORE
FOR LIKE NEW APPROACHES FOR
VACCINES, YOU KNOW?
IF THEY'RE NOT IN THE VACCINES
DEVELOPED LIKE MRNA OR LIKE
TRYING NEW APPROACHES TO IMPROVE
THE VACCINES IN THAT PART OF
THESE OR IT WILL NOT BE?
>> WELL, AS A PARTNERSHIP
CONCEPT OR A PARTNERSHIP
INITIATIVE, THEY ARE USUALLY
FOCUSED ON OF COURSE I FORGOT TO
SAY SOMETHING THAT WAS VERY
IMPORTANT, WHICH WAS THAT THIS
IS ACTUALLY INTENDED TO BRIDGE
THE GAP BETWEEN--IN THE AREA OF
TRANSLATIONAL RESEARCH TO GET
TOWARDS CLINICAL TRIALS AND
CLINICAL STUDIES.
SO THAT WAS REALLY THE FOCUS OF
THIS SO IN A LOT OF MEETINGS
WE'VE HAD, PART OF THE
DISCUSSION WAS THE NEED TO LOOK
AT NEXT GENERATION VACCINES AND
DIFFERENT KINDS OF INNOVATION AT
THE SAME TIME GIVEN THE CURRENT
ISSUES, WE DIDN'T REALLY WANT TO
GIVE UP ON THE CURRENT VACCINE
CANDIDATES THAT ARE OUT THERE
AND AGAIN PART OF THE
PARTNERSHIP IS ALWAYS LOOKING AT
THINGS THAT HAVE TO HAVE A LEAD
PRODUCT.
SO THERE WASN'T AN INTEREST IN
DENYING BASIC DISCOVERY BUT
HOPEFULLY WHOEVER COMES IN WILL
HAVE A VACCINE CANDIDATE OF ANY
TYPE AS LONG AS IT'S A WORTH
WHILE VACCINE CANDIDATE AND OF
COURSE THAT WILL BE DETERMINED
IN PEER REVIEW, WE ARE HAPPY TO
SEE IT.
>> OR AN INNOVATIVE PLATFORM
COULD MEET THE MILESTONES OF AN
RO1 DRIVEN PLATFORM--
>> YEAH, I THINK THAT COULD BE
INCLUDED IN THE LANGUAGE, THAT
IS NOT EXCLUDING--TO NOTE THAT
THERE ARE ANY OTHERS THAT MIGHT
ALREADY HAVE THAT PLATFORM IN
PLACE.
>> OKAY, THAT'S GREAT.
THANK YOU FOR THAT INSIGHT.
THAT IS VERY HELPFUL.
>> OKAY.
IF THERE ARE NO FURTHER
QUESTIONS, WE CAN MOVE ON TO OUR
NEXT PROPOSED INITIATIVE, WHICH
IS ENTITLED PARTNERSHIPS FOR THE
DEVELOPMENT OF NOVEL
THERAPEUTICS TO COMBAT
ANTIBIOTIC RESISTANT BACTERIA
AND FUNNING I.
ZUOYU XU WILL GIVE THIS
PRESENTATION.
ARE YOU THERE?
>> I AM HERE, THANK YOU EMILY.
>> YEAH, GOOD AFTERNOON,
EVERYONE.
I'M ZUOYO, XU IS PRONOUNCED
ASHOE, AND PROGRAM OFFICER FOR
THERAPEUTIC TO COMBAT AND WITH
THE BACTERIAL DMID AND IT'S MY
PLEASURE TO PRESENT TO YOU
PARTNERSHIPS FOR THE DEVELOPMENT
OF NOVEL THERAPEUTICS TO COMBAT
ANTIBIOTIC RESISTANT BACTERIA
AND THE THE FUNGI.
OKAY, I SEE THAT.
THE OBJECTIVE FOR THIS CONCEPT
IS TO SUPPORT PRECLINICAL
DEVELOPMENT OF A NEW CLASSES OF
ANTIBIOTICS.
AND NONTRADITIONAL ANTIMICROBIAL
THERAPEUTICS ACTING AGAINST
MULTIDRUG-RESISTANT
ACINETOBACTERIAER, PSEUDOMONAS,
ENTERO BACTERIA CAEE AND CANDIDA
AURIS AND THIS IS A NEW PROPOSAL
AND WE PARTNERSHIP WITH R01 AND
ANTICIPATE 6-8 AND THE FIRST
YEAR TOTAL COST FOR AWARD
INITIATIVE IS $4 MILLION.
>> THE BACKGROUND, AS WE KNOW
ANTIBI BOTTIC
RESISTANCE--ANTIBIOTIC
RESISTANCE IS A TOP THREAT TO
PUBLIC HEALTH NEEDS AND IT IS
PRIORITY OF THE GLOBAL ACROSS
THE GLOBE.
THERE ARE NATIONAL AND
INTERNATIONAL EFFORTS TO ADVANCE
EABT BIOTICS RESISTANCE, THE W.
H. O. COVERED THE PRIORITY
THERAPEUTICS LIST FOR R&D--AS
CRITICAL.
BUT WHY THE VECTOR FOR MONEY,
SECOND IS A SUED MOANIS
ALLOGENOSA, AND THE ENTHUSIASMER
O BACTERIAIARIAL SEA.
AND THEN THE [INDISCERNIBLE]
MANY ABOUT THE FUNGAL INFECTIONS
HERE, THAT IS IN THE NEW YORK
TIMES SHOW THAT FOR THE
INFECTIONS BY THE CANDIDA AURIS
AND THE CDC LISTED THESE AS
URENTLY NEEDS TO FIND
ANTIBIOTICS.
THE U.S. GOVERNMENT LAUNCHED AS
A NATIONAL ACTION PLAN FOR
COMBATING ANTIBIOTIC RESISTANT
PROGRAM IN 2014 CALLING FOR A
FEDERAL RESPONSE TO ADDRESS THE
GROWING THREATS OF ANTIBIOTIC
RESISTANCE.
THIS PLAN HAS BEEN RENEWED FOR
2020 TO 2025.
AND RECENTLY UPDATED THE NIAR
RESEARCH FRAMEWORK THE INSTITUTE
DESCRIBED A STREAMLINED RATE OF
INNOVATIVE STRATEGIC APPROACH TO
UPON A. E. R. RESEARCH THAT
INCLUDES REINVIGORATING GRAM
NEGATIVE DRUG DISCOVERY,
HARNESSING THE IMMUNE SYSTEM AND
DEVELOPING NONTRADITIONAL
PROLAPSE TO TREAT INFECTIOUS
DISEASE.
IN 2019 A. R. THREATS REPORT,
THE CDC ESTIMATED THAT AT THE
LEAST, 2.8 MILLION PEOPLE
DEVELOP AN ANTIBIOTIC RESISTANCE
TO INFECTIONS AND MORE THAN
35,000 PEOPLE DIE AS A RESULT OF
THIS IN THE STATES.
TO MAKE A NATIONAL CAUSE TO
ACHIEVE THE RESISTANCE,
INFECTIONS CAN BE MORE THAN 4.6
BILLION DOLLARS ANNUALLY.
SO THIS CONCEPT WILL FOCUS ON
WHAT I JUST MENTIONED THE TOP 4
PATHOGENS.
THAT'S PRIORITY AND CRITICAL AND
URGENT.
SHOWED HERE, GLOBE ALTHOUGH
[INDISCERNIBLE] FOR THE
[INDISCERNIBLE].
TWELVE NEW ANTIBIOTICS HAVE BEEN
APPROVED SINCE 2014, MOST OF THE
DRUGS ARE NEW MEMBERS OF
EXISTING CLASSES OF ANTIBIOTICS.
REGARDING CANDIDA AURIS IS IN
DEVELOPMENT.
DESPITE EXTENSIVE EFFORT TO
STIMULATE THE [INDISCERNIBLE] IT
STILL REMAINS SEEN AND
[INDISCERNIBLE].
ESPECIALLY AS THE GRAM NEGATIVE
PATHOGENS.
SO WAIT TO EVEN NEW CLASSES OF
ANTIBIOTICS AS WELL AS
NONTRADITIONAL ANTIMICROBIAL
THERAPEUTICS TO COMBAT
ANTIBIOTIC RESISTANCE.
SCOPE OF THIS SUPPORT?
AS ALREADY DISCUSSED, THE
CONCEPT SUPPORTS PRECLINICAL
DEVELOPMENT OF A NEW CLASSES OF
ANTIBIOTICS IN THE
NONTRADITIONAL ANTIMICROBIAL
THERAPEUTICS THAT ACT AGAINST
MULTIDRUG RESISTANCE PSEUDOMOAN
ISOTOPE AND ENTERO BACTERIA ACA
OR CANDIDA AURIS.
OF THE [INDISCERNIBLE] STATE, A
FEW KEY WORDS HERE.
FIRST THE CONCEPT SUPPORTS
PRECLINICAL DEVELOPMENT, NOT
EARLY STAGE DISCOVERY OR
CLINICAL STAGE EVALUATION.
SECONDLY, IT SUPPORTS NEW
CLASSES OF ANTIBIOTICS, NOT JUST
NEW ANTIBIOTICS, AS MENTIONED,
MOST RECEIPTLY APPROVED
ANTIBIOTICS, AND THE MOST
CANDIDA IS IN CLINICAL
DEVELOPMENT ARE NEW MEMBERS OF
EXISTING CLASSES.
THE OVERWHELMING RESISTANCE
PROBLEMS WILL MAKE THIS NEW
DRUGS--AND THE EVEN LITTLE OR NO
SPACE FOR FURTHER MODIFICATIONS
WHEN NEEDED.
AND THIRD, NONTRADITIONAL
MICROBIAL THERAPEUTICS INCLUDE
BUT ARE NOT LIMITED TO BACTERIAL
PHAGES THERAPY, APPROACH TO
[INDISCERNIBLE] THE HOST SYSTEM
AND THE COUNTERMEASURES TO
SUPPRESS MILLIONS OF PATHOGENS.
FINALLY, RESPONSIBLE
APPLICATIONS MUST TARGET AT
LEAST 1 OF THE 4 RESISTANT
PATHOGENS.
SUPPORTED EFFORTS ARE FORMA
CODYNAMMICS FORMA COTOXICOLOGYS,
AND THE STUDIES ADDRESS
EFFICACY, TOXICITY AND THE
SAFETY.
FROM ADDITION TO THAT, GMP
MANUFACTURE AND IND ENABLING
ACTIVITIES ARE ALLOWED.
THE PARTIC PAIGDZ IS STRONGLY
RECOMMENDED BUT NOT REQUIRED.
THIS IS BECAUSE OVER DECADES
ACADEMIC INSTITUTIONS HAVE
ESTABLISHED THE PLATFORMS AND TD
FACILITIES AND ACQUIRED NEEDED
EXPERTISE AND EXPERIENCE IN
SUPPORT OF NEW ANTIBIOTICS
DEVELOPMENT.
THEREFORE, IN THIS CONCEPT,
WHILE APPRECIATION IN THE ACTUAL
PARTICIPATION THAT HAS BEEN
CONTRIBUTING BEAUTY INDUSTRIALLY
TO THE SUCCESS OF PARTNERSHIP
PROGRAM, WE DON'T WANT TO
EXCLUDE THE ACADEMIC IONIZATIONS
TUITIONS WITH A SIMILAR
CAPACITY.
NOW I WOULD LIKE TO DISCUSS WHY
WE PROPOSE THE PROPOSALS.
FIRST, THEY PROVIDE A TAYLORED
EXPERTISE IN A RICH ENVIRONMENT
FOR PRODUCT DEVELOPMENT OR FOCUS
THE PROJECTS.
SECOND, SEEM DRUG DEVELOPMENT
PROGRAMS USUALLY INVOLVES A
LARGE NUMBER OF ANIMALS SUCH AS,
MICE, RATS, RABBITS OR EVEN
BIGGER ANIMALS AND CONSUME A
LARGER QUANTITY OF A
PRODUCT/MATERIALS THAT ARE ALL
EXPENSIVE.
R01S CAN PROVIDE A REASONABLE
BUDGET TO HELP.
HISTORICALLY WE HAVE RECEIVED A
ROBUST RESPONSE FROM PIs TO
PARTNERSHIPS CALLED AND FINALLY,
THE RETURN ON INVESTMENT IS
GREAT.
THE PARTNERSHIPS PROGRAM
SIMILARLY THERAPEUTICS
DEVELOPMENT, GRADUATES MAY
SERVE--ADVANCE TO CLINICAL
DEVELOPMENT, ALL BE CONSIDERED
IN OTHER FORMS FORMS--PORTFOLIOS FOR
FURTHER DEVELOPMENT.
THANK YOU FOR TAKING THE TIME TO
REVIEW THIS CONCEPT.
OVERALL, THE COUNCIL FEEDBACK
AND VERY POSITIVE.
COUNCIL FULLY SUPPORTS THE
PRECLINICAL DEVELOPMENT OF A NEW
CLASSES OF ANTIBIOTICS AND THE
NONTRADITIONAL THERAPEUTICS
BECAUSE THEY ADDRESS UNMET
PUBLIC HEALTH NEEDS.
FOR CANDIDA AURIS, IS IN
DEVELOPMENT BECAUSE WE REALIZE
THAT THIS EFFORT IS TO ADDRESS
UNMET NEEDS IN THE TREATMENT OF
CANDIDA AURIS INFECTIONS.
COUNCIL ALSO CONSIDERED THAT
THIS PROPOSED RESEARCH MAY PART
OF THE NEXT GENERATION SOLUTIONS
FOR AR.
COUNCIL SUGGESTS WE PAY
ATTENTION TO ANIMAL MODELS,
DEVELOPED AND LEAD OPTIMIZATION
HAD WHEN APPLICATION COME IN,
SINCE THIS ARE IMPORTANT AND
USEFUL.
AS WE JUST DISCUSSED THIS
CONCEPT TO SUPPORT DEVELOPMENT
OF NEW CLASSES OF ANTIBIOTICS
AND NONTRADITIONAL THERAPEUTICS
THAT IS TARGETING MULTIDRUG
RESISTANCE PATHOGENS AND THE NEW
CONCEPT, WE WILL USE RO1
MECHANISM, 6-SIT CITATIONS WILL
BE AWARDED.
THANK YOU.
I'M HAPPY TO TAKE YOUR
QUESTIONS.
>> THANK YOU ZUOYO, DO YOU HAVE
ANY QUESTIONS OR ADDITIONAL
FEEDBACK FROM COUNCIL MEMBERS.
I'M NOT SEEING ANY RAISED HANDS
ON MY SCROOM GALLERY.
OKAY.
THANK YOU.
>> THANK YOU.
SO WE WILL KEEP MOVING FORWARD
ON OUR AGENDA.
THE NEXT AND LAST PRESENTATION
IS DEVELOPMENT AND OPTIMIZATION
OF NEXT-GENERATION IMMUNE O
LOGIC ASSAYS TO SUPPORT
INFLUNNENSA CLINICAL STUDIES AND
TRIALS.
AND DR. CHELSEA LANE FROM THE
RESPIRATORY DISEASE BRANCH WILL
PRESENT THIS.
>> GREAT.
THANK YOU SO MUCH EMIMPEDIMENTSY
FOR THE INTRODUCTION AND THANKS
FOR THE OPPORTUNITY TO PRESENT
THIS CONCEPT TODAY.
SO MY NAME IS CHELSEA LANE, I'M
A PROGRAM OFFICER WITHIN THE
RESPIRATORY DISEASES BRANCH AND
I'LL BE PRESENTING THIS CONCEPT
FOR FY23 ENTITLED DEVELOPMENT
AND OPTIMIZATION OF NEXT
GENERATION IMMUNEOLOGICAL ASSAYS
TO SUPPORT INFLUENZA CLINICAL
STUDIES AND TRIALS.
SO THE OBJECTIVE OF
THIS INITIATIVE IS SUPPORT
COLLABORATIVEY MULTIDISCIPLINARY
RESEARCH TO DEVELOP AND
OPTIMIZE, NEXT GENERATION
IMMUNEOLOGICAL ASSAYS THAT ARE
READILY UTILIZED AND CLINICAL
STUDIES AND TRIALS BY THE END OF
THE 5 YEAR PROJECT PERIOD.
SO THIS WILL BE A NEW INITIATIVE
AND WOULD UTILIZE THE PHASED
UH2-/UH3 COOPERATIVE MECHANISM
WHICH WILL WILL DESCRIBE IN A
SUBSEQUENT SLIDE.
WE ANTICIPATE AWARDING 3-5
APPLICATIONS AND THE PHOTTAL
COST FOR THIS INITIATIVE WOULD
BE AROUND 5 MILLION IN TOTAL
COST FOR YEAR 1.
SO IN 2018, NIAID PUBLISHED THE
STRATEGIC PLAN TEEJIC PLAN FOR
ADDRESSING RESEARCH AREAS TO
CREATING SAFE AND EFFECTIVE
INFLUENZA VACCINES AND A
SCHEMATIC OF THIS PLAN IS
ILLUSTRATED HERE AND FOCUSES ON
3 KEY AREAS ARE INFLUENZA
RESEARCH, RESEARCH AREA 1 THAT
INVOLVES IMPROVING THE
UNDERSTANDING OF THE
TRANSMISSION, NATURAL HISTORY,
AND PATHOGENESIS OF INFLUENZA
INFECTION.
RESEARCH AREA 2, WHICH INVOLVES
THE PRECISE CHARACTERIZATION OF
PROW PROTECTIVE INFLUENZ
IMMUNITY OCCURS AND HOW TO
TAYLOR VACCINATION RESPONSES TO
ACHIEVE IT AND RESEARCH AREA 3
WHICH AIMS AT SUPPORTING THE
RATIONAL DESIGN OF UNIVERSAL
INFLUENZA VACCINES INCLUDING
DESIGNING IMMUNE O GENS ANDAD
JUSTICE ACCESS VENTS TO BOOST
IMMUNITY AND EXTEND THE
PREPARATION, THE PLAN INCLUDES
COST CUTTING RESEARCH AREAS AS
IS DESIGNATED HERE WITHIN THE
RED ARROWS, SO WITHIN OBJECTIVE
2.4 RESEARCH AREA 2 IT
SPECIFICALLY CALLS OUT A NEED
FOR DEVELOPMENT OF NEW ASSAYS
AND REAGENTINGS, PARTICULARLY AS
NEW VACCINE PLATFORMS AND
ANDROGEN ROUGH ATOMGENIC TARGETS
EVOLVE.
SO ON MARCH 31st, 2019 THE
NIAID HOSTED I MEETING ENTITLED
IMUGEYOLOGICAL ASSAYS CORRELATES
OF PROTECTION FOR NEXT
GENERATION INFLUENZA ACSEENS AND
THESE WILL BE NEEDED TO PROTECT
THE EFFICACY OF NEXT GENERATION
INFLUENZA VACCINES INCLUDING
BROADLY USED INFLUENZA VACCINES
AND VACCINE CANTIDATES.
SO ALL OF THE RESEARCH BEING
DONE UNDER OUR NETWORK, DEPICTED
HERE TO THE LEFT HAS LED TO AN
EXPANDED NUMBER OF COHORTS OF
DIFFERENT AGED AND AT-RISK
POPULATIONS AS WELL AS AN
EXPANDED NUMBER OF CLINICAL
TRIALS WITH DIFFERENT TYPES OF
VACCINE CANDIDATES.
HENCE THE EXPANDED
INFRASTRUCTURE HAS LED TO A NEED
FOR NOVEL HIGH THROUGH PUT
ASSAYS TO DETERMINE CORRELATES
OF PROTECTION RATHER THAN THE
CLASSICAL INHIBITION, AND
MICRONEUTRALLIZATION ASSAYS.
AS WELL AS APPROVED SAMPLING
TECHNIQUES FOR EXAMPLE, MUCOSAL
SAMPLING, FOR MUCOSAL ASSAYS ARE
NONINVASIVE, TECHNIQUES OR
ASSAYS THAT UTILIZE SMALLER
VOLUMES FOR EXAMPLE, FOR
PEDIATRIC POPULATIONS.
SO CURRENTLY INVESTIGATOR
INITIATED RESEARCH ON
IMMUNEOLOGICAL ASSAY DEVELOPMENT
IS LIMITED AND RELATED ASSAY
DEVELOPMENT ACTIVITIES UNDER
BROADER PROGRAMS ARE IN GENERAL
SPECIFIC TO THE NEEDS OF THAT
PROGRAM.
SO THE GOAL OF THIS INITIATIVE
WILL BE TO COMPLEMENT EXISTING
PROGRAMS BY PULLING OUTSIDE
INVESTIGATOR WHO IS ARE
DEVELOPING NOVEL ASSAYS TO
EXPAND OR NIAID CLINICAL
PROGRAMS ASSAY DEVELOPMENT
CAPABILITIES.
SO THE SCOPE OF THIS INITIATIVE
IS DEVELOPING ASSAYS FOR MUCOSAL
IMMUNE RESPONSES OR PLATFORM
TECHNOLOGIES THAT ARE MORE HIGH
THROUGH PUT.
ONE EXAMPLE OF THE LATTER COULD
INCLUDE A MORE HIGH THROUGH PUT
CRYOEM TECHNOLOGY THAT CAN
CHARACTERIZE A LARGER NUMBER OF
CLINICAL SAMPLES FOR ANTIBODY
RESPONSES ILLICITTED BY
VACCINATION OR INFECTION, OTHER
ACTIVITIES THAT WILL BE
CONSIDERED IN SCOPE IMPROVE
SAMPLING TECHNOLOGIES IT TO
SAMPLE MUCOSAL IMMUNE RESPONSES
FOR TEAKNIQUES THAT ARE
NONINVASIVE OR UTILIZE SMALLER
VOLUMES.
APPLICANTS, APPLICATIONS
THAT--APPLICANTS WOULD BE
REQUIRED TO DOCUMENT ACCESS TO
CLINICAL STUDY OR TRIAL SAMPLES
AND APPLICATIONS THAT WOULD BE
CONSIDERED NONRESPONSIVE INCLUDE
BASIC RESEARCH FOCUSED ON
BIOMARKER DISCOVERY, RESEARCH
FOCUSED ON CLASSICAL
HEMOGLIEWTDINNATION, MICROOR
[INDISCERNIBLE] APPLICATION
ASSAYS AND APPLICATIONS THAT
PROPOSE A CLINICAL TRIAL.
SO THIS WOULD UTILIZE THE UH2/3
PROGRAM FOR NIAID STAFF WHO HAVE
SUBJECT MATTER EXPERTISE IN
DEVELOPMENT AND OPTIMIZATION.
THE RESEARCH STRATEGY MUST
INCLUDE MILESTONES TO BE
ASSESSED AT THE END OF THE UH2
PHASE AND PRIOR TO THE END OF
THE UH2 PHASE, PRIOR TO THE END
OF THE TRANSMISSION PACKAGE
WHICH INUDPGA KLF-TWOS THE
PROGRESS REPORT DETAILING THE
PROGRESS TOWARD THE MILESTONES
AS WELL AS DESCRIPTION OF HOW
THEY PROPOSED FOR THE UH 3 PHASE
IS SUPPORTED BY THE COMPLETION
OF THE UH 2 PHASE MILESTONES.
SO EXAMPLES OF PHASE 1
ACTIVITIES MAY INCLUDE
OPTIMIZATION OF SAMPLE
COLLECTION PROCEDURES AND
IDENTIFYING ASSAY AND PLATFORM
SAMPLES AND ACTIVITIES COULD
INCLUDE ASSAY DEVELOPMENT AND
THE FACE 1 OR 2 ACTIVITIES THAT
ARE PROPOSED AND APPLICATIONS
CAN TAIL LORA RODRIGUEZ 1 AND 2
ACTIVITIES TO FIT THE CURRENT
STAGE OF TWEPMENT FOR THEIR
SPECIFIC ASSAY.
I WANT TO TAKE A MINUTE TO THANK
DR. FERNANDEZ-SESMA AND
DR. GREENBERG, FOR THEIR SUPPORT
OF THE INITIATIVE.
THEY ALSO RECOGNIZE THE NEED FOR
NOVEL HIGH-LIEU PUT ASSAYS AND
EMPHASIZE THE IMPORTANCE OF
SAMPLING TECHNOLOGIES, SPECIALLY
THOSE THAT ARE NONINVASIVE AND
SAMPLING OBVIOUSLY FOR PEDIATRIC
POPULATION.
SO THIS IS THE RECAP SLIDE FOR
THE INITIATIVE CONCEPT AND I AM
HAPPY TO ADDRESS ANY QUESTIONS
ANYONE MAY HAVE AT THIS TIME.
>> THERE ARE ANY QUESTIONS OR
COMMENTS FROM ANY SUBCOUNCIL
MEMBERS?
ANNA?
>> I JUST WANT TO SAY THIS HAS
BEEN A LONG ONGOING QUESTION OR
PROBLEM OR LACK OF A BIG NEED IN
THE INFLUENZA FIELD BECAUSE WE
RELY HEAVILY ON VERY KIND OF OLD
FASHIONED TYPE OF--I THINK ALSO
IT WAS IN THE DISCUSSION FOR
OTHER, MAYBE OTHER TARGETS FOR
THE ASSAYS OR PARTICULAR HOW
MANY WERE VERY ENCOURAGING AND I
THINK IT'S IMPORTANT WE DON'T
JUST FOCUS MOSTLY ON THE HA BUT
IT'S AN ONGOING PROBLEM THAT HAS
TO BE ADDRESSED AND WE ARE
REALLY SUPPORTIVE, WE WERE VERY
SUPPORTIVE OF THESE HOPEFULLY
VERY IMPORTANT THING WILL COME
OUT OF THIS INITIATIVE BECAUSE
THERE IS A BIG NEED FOR THAT.
IT'S AMAZING WE HAVE SO MUCH
RESEARCH AND INFLUENZA, WE STILL
DON'T HAVE VERY HIGH THROUGH PUT
ASSAYS THAT ARE USED WIDELY ALL
OVERALL STRATEGY THE WORLD.
>> HARRY DO HAVE YOU YOUR HAND
UP?
>> YEAH, I ENDORSE WHAT ANA SAID
AND I WOULD SIMPLY SAY THAT WITH
THE ADVENT OF RNA BASED
VACCINES, THERE REALLY IS GOING
TO BE MORE VACCINATION WHERE
NEUROMITT DACE IS A LEGITIMATE
TARGET THAT CAN BE STANDARDIZED
AND THE ASSAYS ARE PRETTY OLD
FASHIONED FOR NEUROMENA DICE AND
IT'S IMPORTANT TO GET THOSE IN
PLACE BECAUSE PRETTY SOON YOU
WILL HAVE ALL SORTS OF RNA
VACCINATION EFFORTS WITH FLU AND
IF WE'RE STILL DOING NEUROMENA
DAZE, TELL BE INSANE.
>> I AGREE COMPLETELY.
>> I DON'T SEE ANY OTHER HANDS
RAISED.
ANY OTHER FINAL COMMENTS OR
FEEDBACK FROM THE GROUP?
WELL, WE GET TO FINISH EARLY
THEN.
SO THANK YOU.
THANKS TO THE SUBCOUNCIL MEMBERS
FOR PARTICIPATING AND FOR DOING
YOUR HOME WORK AND COMING
PREPARED.
THANKS TO ALL THE PRESENTERS
TODAY.
I THINK OUR NEXT COUNCIL MEETING
WILL BE--WELL IT WILL BE MAY
COUNCIL, I DON'T EXACTLY KNOW
THE DATE BUT WE WILL SEE YOU
THEN IF NOT SOONER.
SO THANK AND YOU FAREWELL.