>>WELCOME TO NHLBI COUNCIL
>> I'LL QUICKLY GO OVER THE
AGENDA SO WE KNOW WE HAVE
SCHEDULED FOR OUR MEETING TODAY
SO WE'LL BEGIN WITH DR. GIBBONS'
REPORT ALONG WITH DR. CLAUDIA
KEMPER AND WE'LL REVIEW THE
NHLBI CONCEPTS FOR CLEARANCE
DISCUSSED AT THE MEETING BEFORE
WE END THE OPEN SESSION.
IT'S A PACKED AGENDA SO I THINK
WE SHOULD GO AHEAD AND GET
STARTED.
PATRICK GIBBONS, WE'RE ANXIOUS
TO HEAR YOU'RE REPORT.
>> THANKS VERY MUCH.
>> AS IS OUR CUSTOM I'LL ADDRESS
OUR ACCOUNTABLE STEWARDSHIP
ELEMENTS AS WELL AS SCIENTIFIC
OPPORTUNITIES ARE EXHIBITING OUR
PRIORITIES.
FIRST A REVIEW OF WHERE WE ARE
WITH THE FISCAL YEAR 2022
BUDGET.
FIRST YOU'LL NOTE A NOTE OF
APPRECIATION FOR THE BIPARTISAN
SUPPORT OF NIH PARTICULARLY OVER
THE LAST SEVERAL YEARS THAT HAS
YIELDED YEAR OVER YEAR INCREASES
THAT HAVE HELPED US STAY JUST
ABOVE AND AHEAD OF INFLATION.
WITH SARS COV2 INFECTION AND
HIGHLIGHTING AREAS OF CONCERN
RELATED TO THE NEXT GENERATION.
A FEW IMPORTANT THEMES THAT WERE
NOTEWORTHY WAS COMORBIDITY AND
MORTALITY THAT INTERSECTS WITH
HEALTH DISPARITIES RESEARCH.
CLIMATE CHANGE AND HEALTH AS
WELL AS HOW WE'RE DEALING WITH
THE STRUCTURAL RACISM AND ENDING
HARASSMENT.
TOWARD THAT END, THE CONGRESS
DID APPROPRIATE AN INCREASE
ABOVE FY21 TO NIH OVER ALL AND
FORTUNATELY THE NHLBI WAS PART
OF THAT RISING TIDE WITH AN
INCREASE OF 3.9% OVER ALL AND OF
PARTICULAR NOTE OF A BASE
INCREASE OF THE SEAL PROGRAM
COMMUNITY ENGAGED ALLIANCE
AGAINST COVID DISPARITIES THAT
NHLBI CO-LED WITH THE NIMHD AS
PART OF THE TRANS-NIH EFFORT TO
PROMOTE COMMUNITY-ENGAGED
RESEARCH AS PART OF THE PANDEMIC
RESPONSE WITH A PARTICULAR FOCUS
ON UNDER SERVED COMMUNITIES,
COMMUNITIES OF COLOR THAT WERE
DISPROPORTIONATELY AFFECTED BY
THE PANDEMIC.
ALSO NOTABLE IN THE
APPROPRIATION NOT ONLY WAS THAT
$45 BILLION FOR NIH OVER ALL,
AGAIN A PARTICULAR CALL OUT TO
AN INCREMENT GIVEN TO SUPPORT
MATERNAL MORBIDITY AND MORTALITY
RESEARCH PARTICULARLY THE
IMPROVE PROGRAM A TRANS-NIH
INITIATIVE FOCUSSED IN ON
MATERNAL HEALTH WITH EMPHASIS ON
THE STRIKING RACIAL ETHNIC
DISPARITIES IN MATERNAL HEALTH
THAT THE NHLBI IS PARTICIPATING
IN GIVEN OUR PORTFOLIO.
SIMILARLY, A $1 BILLION
ALLOCATION TO ARPA-H AS A NOVEL
ENTITY IN HHS.
ARE THIS ENABLES US TO PURSUE
SOME PRIORITIES IN PROMOTING
INVESTIGATOR-INITIATED SCIENCE.
AND WE'VE TRIED TO MAINTAIN A
STEADY CONSISTENT PREDICTIVE AND
SUSTAINABLE PRIORITY FOR OUR RO1
INVESTIGATORS SEEKING TO
MAINTAIN A SUCCESS RATE IN THE
20s.
IT DIPPED A LITTLE BIT BELOW
THAT THIS YEAR BUT AS YOU MAY
NOTICE, THAT THE SUCCESS RATE IS
A FRACTION OR A RATIO OF
APPLICATIONS TO AWARDS.
YOU'LL SEE THAT THERE'S A
PARTICULAR INCREASE IN THE
NUMBER OF APPLICATIONS WE
RECEIVED OVER THE LAST FOUR
YEARS.
IT'S FAIRLY SUBSTANTIAL, 2942 IN
2018 AND 3700 IN 2022.
THAT INCREASE IN APPLICATIONS
HOPEFULLY IS INDICATIVE OF A
VIBRANT COMMUNITY OF SCIENTISTS
WITH A LOT OF GREAT IDEAS.
THE CHALLENGE THAT OUR
APPROPRIATION HASN'T QUITE KEPT
UP WITH THAT EXUBERANT RESPONSE
EVEN THOUGH WE'RE STILL GIVING
OUT MORE AWARDS OVER ALL THAT
HAS RESULTED IN A SLIDE DIP IN
THE SUCCESS RATE.
WE'RE SEEKING TO SUSTAIN AND
MAINTAIN SUCCESS RATE FOR
EARLY-STAGE INVESTIGATORS WITH
THE 10-POINT HANDICAP AND ABOVE
THE 15% THIS TIME THAT YIELDED A
SUCCESS RATE IN THE MID 30s WE
TRY TO MAINTAIN AS WELL AS A
ROBUST SUCCESS RATE FOR OUR K
AWARDS AS PART OF OUR COMMITMENT
TO THE NEXT GENERATION.
LET ME PIVOT FROM STEWARDSHIP TO
ADVANCING SCIENTIFIC PRIORITIES.
FIRST AND FOREMOST, I WANT TO
GIVE A PARTICULAR SHOUT OUT AND
ACKNOWLEDGEMENT, RECOGNITION, TO
OUR BELOVED SCIENTIFIC DIRECTOR
DR. BALABAN WHO HAS MADE THE
DECISION TO STEP DOWN AS
SCIENTIFIC DIRECTOR.
HE'S NOT LEAVING US, HE'S GOING
TO KEEP HIS LAB BUT AFTER 20
YEARS AS SCIENTIFIC DIRECTOR
HE'S STEPPING DOWN FROM THAT
POSITION AND ACCORDINGLY WE'VE
INITIATED A SEARCH PROCEEDING
QUITE WELL ACCORDING TO OUR
TIMETABLE.
WE ARE CONFIDENT WE'LL BE ABLE
TO ENABLE BOB TO RETURN TO HIS
LAB IN THE VERY NEAR FUTURE.
BOB HAS DONE A FABULOUS JOB AS
SCIENTIFIC DIRECTOR.
I THINK HE'S BEEN A MODEL AS A
SCIENTIFIC DIRECTOR AND ACHIEVED
AND ACCOMPLISHED SO MUCH.
IN PART RELATED BECAUSE HE'S A
TERRIFIC SCIENTIST AND THIS IS
AN ATTEMPT TO GIVE HIM A SHOUT
OUT OF THE SCIENTIFIC
ACHIEVEMENTS THAT HE HAS.
HE'S NOT ONLY BRILLIANT BUT A
SMART MAN BECAUSE WHEN WE HAD
ONE-ON-ONES HE OFTEN SHARES WITH
ME WHAT'S GOING ON IN HIS LAB
AND WHAT HE'S EXCITED ABOUT AND
ONE OF THE CHALLENGES OF BEING
DIRECTOR OF NHLBI A NEEDED FIX
FOR SCIENTIFIC DATA ON A
RECURRENT BASIS.
JOB'S A RELIABLE SOURCE FOR THAT
AND JUST GETTING INSIGHTS IN HIS
FASCINATION WITH MITOCHONDRIAL
BIOLOGY HAS BEEN FUN AND I'VE
BEEN BLOWN AWAY BY HIM SHARING
HIS WORK.
IT'S REALLY STATE OF THE ART IN
TERMS OF USING OPTICAL
TECHNIQUES AND ISOLATED HOUSE
HEART TO TRACK WITH NMR SPECTRA
AND THE METABOLISM OF THE HEART
IN AN ELEGANT WAY EVEN THE
HISTORIC STANLEY SURNOOFF WOULD
BE PROUD IS STILL GOING OFF ON
AT THE NIH AND AT THE LEVEL OF
ELEGANCE WE'RE CAPABLE IN 2022.
AND BOB'S LAB TAKING A SYSTEMS
APPROACH AND PROTEOMICS,
ETCETERA, HAS REVEALED SOME
ASTOUNDING THINGS IN TERMS OF
THE MITOCHONDRIA OF THE HEART
AND THE NETWORKS AND RETICULA
AND MAYBE THAT'S WHAT WE'LL MAKE
HIM DO IS GIVE A TALK AND SHARE
OBSERVATIONS.
SUFFICE TO SAY IT'S THAT BURNING
CURIOSITY AND ENERGY THAT'S MADE
HIM AN EXCEPTIONAL SCIENTIFIC
DIRECTOR.
HIS LEGACY WILL JOIN THOSE OF
THE SARNOFFS WHO GRACE THE DIR.
THE INCREDIBLE LEGACY IS THE
ENVIRONMENT CREATED IN OUR
PROGRAM THOUGH I'M BIASSED I AM
UNABASHEDLY WOULD SAY THE BEST
PROGRAM AT NIH.
CERTAINLY PUNCHING ABOVE ITS
WEIGHT.
IT'S ALL ABOUT THE PEOPLE HE'S
RECRUITED AND RETAINED OVER HIS
20-YEAR TENURE.
IN PARTICULAR I'VE ALWAYS CHIDED
HIM HIS JOB IS TO CREATE THE
ENVIRONMENT, THE NEST, IN WHICH
THESE YOUNG INVESTIGATORS CAN
THRIVE.
HE'S RECRUITED AN INCREDIBLE
BEVY OF THEM AND YOU CAN SEE A
DIVERSE GROUP, INCREDIBLY
TALENTED DOING RESEARCH ACROSS
AN INCREDIBLE SPECTRUM OF
SCIENCE AND DISCIPLINES AND
AGAIN HE MAKES US ALL PROUD BY
THE IRP OF THE RESEARCH PROGRAM
HE'S CREATED HERE AND THAT IS
REALLY EXEMPLIFIED BY THESE FINE
INVESTIGATORS AND DURING JUNE
COUNCIL AS MANY ARE FAMILIAR,
THAT'S THE TIME THAT WE TAKE
PARTICULAR NOTE OF COUNCIL IN
WHICH WE SHARE THE READOUTS AND
EVALUATION OF OUR INTRAMURAL
INVESTIGATORS AS THEY UNDER GO
THEIR QUADRENNIAL REVIEWS BY THE
BOARD OF SCIENTIFIC COUNSELORS
IN WHICH THEIR PROGRESS IS
EVALUATED AS PART OF THE
STEWARDSHIP OF THE INTRAMURAL
PROGRAM.
ON THE RIGHT YOU CAN JUST SEE A
BRIEF LIST OF SOME OF THE
ACCOMPLISHMENTS THAT BOB BALBAN
HAS MADE IN TRANSFORMING AND
REENGINEERING AND PUTTING THE
INTRAMURAL PROGRAM ON AN
INCREDIBLE TRAJECTORY.
BOB, YEAR ETERNALLY GRATEFUL TO
YOUR SERVICE TO THE NHLBI AND
RESEARCH PROGRAM AND YOUR
SCIENCE AND SCIENTIFIC
LEADERSHIP NOT ONLY IN THE
INTRAMURAL PROGRAM BUT ACROSS
THE INTRAMURAL RESEARCH PROGRAM
OF THE NIH AND YOUR
CONTRIBUTIONS TO THE SCIENTIFIC
COMMUNITY SO THANK YOU.
THANK YOU.
AS A TASTE OF THE SCIENCE WE
WANT TO HIGHLIGHT DR. CLAUDIA
KEMPER AND WE LOOK FORWARD TO
HER TALK LATER ON.
SHE KIND OF BLEW ME AWAY WITH A
COMPLIMENT SYSTEM AND
TRANSFORMED MY THINK OF THAT
SYSTEM.
WE'RE TRYING TO TRANSLATE
DISCOVERY SCIENCE IN A PUBLIC
HEALTH IMPACT PARTICULARLY AT
THE COMMUNITY LEVEL AND AT THE
LEVEL OF GLOBAL HEALTH
PARTICULARLY AS IT RELATES TO
THE SOCIAL ECOLOGICAL MODEL THAT
APPRECIATES THINGS NOT ONLY AT
THE MOLECULAR LEVEL AND GENETIC
S BUT THE INDIVIDUAL LEVEL,
CULTURE, FAMILY, COMMUNITY,
ENVIRONMENT AND ALL THOSE ARE
CRITICAL TO HEALTH AND DISEASE
AS SOCIAL DETERMINATES OF HEALTH
AND AS WE LOOK AT HEALTH EQUITY
AND DISPARITIES AND GLOBAL
HEALTH, THESE CONSTRUCTS ARE
CRITICALLY IMPORTANT TO INCLUDE
IN HOW WE THINK ABOUT OUR
RESEARCH AGENDA AND OUR RESEARCH
PROGRAM PORTFOLIO.
TOWARD THAT END, ONE OF THE
OUTCOMES OF THE MOST RECENT AND
NIH RESPONSE TO THE PANDEMIC HAS
BEEN THE UNDER SCORE HOW A VIRUS
THAT ATTACKS THE BODY,
PARTICULARLY THE LUNG AND LINING
OF THE BLOOD VESSELS AND END
THELIUM HAS AN IMPACT THAT HAS A
SOCIAL DIMENSION.
THERE'S A REASON WHY THERE'S
CERTAIN RACIAL ETHNIC GROUPS
THAT ARE DISPROPORTIONATELY
AFFECTED BY THE PANDEMIC.
IT'S NOT NECESSARILY RELATED TO
THE STRUCTURE OF THEIR ACE 2
RECEPTOR THE VIRUS USE TO INVADE
THE CELLS BUT REFLECTS THESE
OTHER SOCIAL DETERMINATES OF
HEALTH AND IMPACT.
AND IT'S CRITICAL THAT IF WE'RE
GOING TO TURN DISCOVERY SCIENCE
INTO PUBLIC HEALTH IMPACT, THAT
WE HAVE A RESEARCH PORTFOLIO AND
PLATFORM THAT'S ABLE TO ADDRESS
THREATS TO COMMUNITY HEALTH SUCH
AS THESE.
AND SO AS PART OF I THINK THE
LESSONS LEARNED OF THE PANDEMIC
IS WE NEED PLATFORMS THAT ARE
ABLE TO ADVANCE HEALTH EQUITY BY
ENGAGING COMMUNITIES MOST
VULNERABLE AND THAT FOR ANY
GIVEN THREAT A VARIOUS, CLIMATE
CHANGE OR FRANKLY SOME
NON-COMMUNICABLE DISEASES
DISPROPORTIONATELY AFFECT THESE
COMMUNITIES AND IT COMES FROM
INCLUDING THE DIMENSIONS OF
SOCIAL DETERMINATES OF HEALTH
AND TARGETING OUR RESEARCH TO
LOCAL NEEDS.
LEVERAGING COMMUNITY PLATFORMS
AND PROMOTE BEING INCLUSIVE
COMMUNES AND THOSE AFFECTED
WITHIN THOSE COMMUNITIES AS PART
OF OUR RESEARCH AGENDA AND
FINALLY GOING THAT LAST MILD TO
PROMOTE UPTAKE FOR COMMUNITY
BENEFIT.
TOWARD THAT END THE ALLIANCE
AGAINST COVID DISPARITIES
EXERCISED PRINCIPLES OF
COMMUNITY-ENGAGED RESEARCH AND
BUILDING ON PARTNERSHIPS WITH
COMMUNITIES AND ADDRESSING THE
INFORMATION, PROMOTING
INFORMATION AND AWARENESS AND
ALL PROMOTES AN INCREASE IN
TRUST IN SCIENCE THAT YET AGAIN
THIS PANDEMIC HAS TAUGHT US WE
CANNOT TAKE LIGHTLY.
INDEED IT'S THE CRITICAL ELEMENT
OF OUR SURVIVAL.
IT'S BEEN ONE OF THE FACTORS
THAT IMPEDED OUR ABILITY TO PUT
THIS VIRUS BEHIND US.
AND IT'S CRITICAL TO THE
DISCOVERY SCIENCE YIELDS.
TO THAT END WE'RE REFINE THE
INITIATIVE THAT CREATES A
RESEARCH PLATFORM TO ADVANCE
HEALTH EQUITY BUILDING ON THE
EXPERIENCE OF CEAL AND THE
TECHNOLOGY ASSISTANCE CENTER AND
SERVING AS AN UMBRELLA OF THE
PLATFORM WHICH WE RECENTLY BEGAN
TO INCORPORATE PRIMARY CARE
RESEARCH NETWORKS PARTICULARLY
THOSE EMBEDDED WITHIN
COMMUNITIES OR OFTEN UNDER
SERVED LEVERAGING FEDERALLY
QUALIFIED HEALTH CENTERS, WHERE
THERE'S AN ETHOS OF COMMUNITY
ENGAGEMENT AS PART OF THEIR
DELIVERY OF PRIMARY CARE IN SUCH
THE INTERVENTIONS CAN PENETRATES
THE COMMUNITIES WHERE THESE
INDIVIDUALS LIVE, WORK AND PLAY
AND A MULTI-LEVEL APPROACH TO
ADDRESSING HEALTH INEQUITIES.
SIMILARLY THE PLATFORM HAS
INNOVATED INCORPORATING A
CONSULTATIIVE RESOURCE THAT CAN
PROMOTE TAILORED GUIDANCE FOR
INCLUSIVE PARTICIPATION IN
RESEARCH AND TRIALS AND BEST
PRACTICES FOR COMMUNITY-ENGAGED
RESEARCH, TRAINING MODULES AND
GUIDANCE FOR EXAMPLE FOR
COMMUNITY HEALTH WORKERS AND A
VARIETY OF TOOLS, TOOL KITS,
RESOURCES AND TIP SHEETS.
FINALLY, A KEY COMPONENT OF THE
PLATFORM RELATES TO THE
IMPORTANCE OF COMMUNICATION,
EDUCATION, BI-DIRECTIONAL
KNOWLEDGE EXCHANGE AND THE TOOLS
NECESSARY FOR THAT TO HAPPEN
THAT'S CULTURALLY COMPETENT AND
ENGAGES AND ADDRESSES THE NEEDS
OF A VARIETY OF SETTINGS, RURAL,
AMERICAN INDIAN, LATINO,
AFRICAN, PACIFIC ISLANDER,
ETCETERA.
TOWARD THAT END, WE'VE BEEN
EXERCISING THIS PLATFORM IN
WHICH WE LEARNED IN CEAL WHERE
WE LEARNED TO INTEGRATE VARIOUS
ELEMENTS INCLUDING THE
PRACTICE-BASED RESEARCH NETWORK
COMPONENT TO ENGAGE THE CLINIC
AND THE COMMUNITY FOR ISSUES
SUCH AS TESTING OR FINDING OUT
WHO'S AT RISK AND NEEDS A BOOST
AND THE STRATEGIES NECESSARY TO
ENSURE THOSE COMMUNITIES ARE
AFFECTIVELY PROTECT FROM THE
VIRUS.
LEVERAGING ASSETS AND
CAPABILITIES WITHIN THE
COMMUNITY AND BUTTRESSING THEM
WHERE THEY NEED TO AND ADDRESS
SPECIFIC CONTEXTUAL NEEDS OF THE
COMMUNITY TO PROTECT THEMSELVES.
WE HOPE TO EXTEND THIS MODEL
BEYOND COVID.
ONE EXAMPLE WOULD BE A
COLLABORATION AND COALITION ON
THE EFFORT IN MATERNAL HEALTH IN
WHICH A COMMUNITY-ENGAGED
PROGRAM IS PART OF THE EFFORT
AND MAY PROVIDE THE LINKAGES
BETWEEN PATIENTS AND PROVIDERS
IN A WAY THAT WOMEN BOTH BEFORE,
DURING AND AFTER PREGNANCY CAN
BE PUT ON THE BEST POSSIBLE
TRAJECTORY TO NOT ONLY HAVE A
HEALTHY PREGNANCY AND BABY AND
BE ON A PATHWAY TO OPTIMAL
CARDIOVASCULAR HEALTH.
ONE EMERGING APPLICATION IS IN
THE SPACE OF CLIMATE AND HEALTH.
EMERGING TRANS-NIH INITIATIVE
LED BY NIEHS WHERE NIH WILL BE
RESPONDING TO THE EXISTENTIAL
THREATS OF CLIMATE AND HEALTH
AND LEVERAGING THE STRATEGY OF
GOING TO THE COMMUNITIES AND
ENGAGING THEM IN HOW TO ADDRESS,
ADAPT AND BECOME RESILIENT TO
THE AFFECTS OF CLIMATE AND
CLIMATE CHANGE THROUGH THE
PLATFORM.
LET ME CLOSE WITH ANOTHER
EXAMPLE OF THAT ENGAGEMENT THAT
EXTENDS OUR PORTFOLIO INTO THE
SPACE OF COMMUNITY ENGAGEMENT
AND SCIENCE TO HAVE PUBLIC
HEALTH IMPACT.
CLEARLY THAT'S AN AREA IN WHICH
THE GLOBAL HEALTH AGENDA IS A
KEY AND WE APPRECIATE THE
LEADERSHIP WHO I HOPE WILL BE
ABLE TO PRESENT TO COUNCIL AT
SOME JUNCTURE AS ONE OF OUR LEAD
COORDINATORS OF OUR GLOBAL
HEALTH EFFORT.
THIS IS AN AREA WHERE AS ALL OF
YOU KNOW, CARDIOVASCULAR DISEASE
AND NON-COMMUNICABLE DISEASE AND
CHRONIC RESPIRATORY DISEASES ARE
RISING ON A GLOBAL SCALE AND
STARTING TO SQUEEZE OUT THOSE
COMMUNICABLE CAUSES OF MORBIDITY
AND MORTALITY THROUGHOUT THE
WORLD.
IT'S IMPORTANT THE NHLBI BE A
GLOBAL LEADER OF NATIONAL HEART,
LUNG AND BLOOD INSTITUTE
RESEARCH RELATED TO CHRONIC LUNG
DISEASE AND IMPACT OF AIR
POLLUTION AS WELL AS BIO MASS
BURNING AND INTERNAL AIR
POLLUTION, IF YOU WILL.
THE RISING RATES OF HYPERTENSION
AND CARDIOVASCULAR DISEASE
THROUGHOUT THE WORLD.
AND PARTICULARLY HAVING IMPACT
ON LOW AND MIDDLE INCOME
COUNTRIES AND CERTAINLY FAMILIAR
WITH OUR BLOOD DISEASE PORTFOLIO
THAT HAS A GLOBAL COMPONENT NOT
ONLY IN BLOOD SAFETY,
HEMORRHAGE, BUT SICKLE CELL
DISEASE AND OTHERS AND HU
HUMEOGLOBENOPATHIES AND THERE'S
A PORTFOLIO THAT GOES THROUGHOUT
THE WORLD.
THOUGH THERE'S A STRATEGIC FOCUS
ON WHERE WE CAN HAVE THE
GREATEST IMPACT.
WE BELIEVE THAT'S IN THE
DEVELOPING WORLD AND LOW AND
MIDDLE INCOME COUNTRIES WITH THE
RISE OF COMMUNICABLE DISEASES,
CARIBBEAN, SOUTH AFRICA AND
SOUTHEAST ASIA.
HERE YOU SEE THE PROBLEM
STATEMENT, IF YOU WILL.
IN THIS CASE RELATED TO
HYPERTENSION THE W.H.O. CALLED
THE BEST BUY IN TERMS OF
INTERVENTIONS THAT CAN HAVE THE
GREATEST IMPACT.
JUST BY HOPEFULLY EXTENDING WHAT
WE ALREADY KNOW WORKS AND ABOUT
WHAT WE KNOW ABOUT HYPERTENSION
AND AWARENESS, TREATMENT AND
CONTROL.
UNFORTUNATELY IN HIGH-INCOME
COUNTRIES WE'VE HAD SUCCESS IN
PROMOTING THOSE ELEMENTS AND YET
YOU LOOK AT AREAS OF THE WORLD
LIKE SUB-SAHARAN AFRICA AND AN
EVER RISING OF UNDIAGNOSED,
UNAWARE, UNTREATED HYPERTENSION.
THAT'S WHERE I BELIEVE THE NHLBI
NEEDS TO MAKE A DIFFERENCE.
TOWARD THAT END, A PROGRAM OF
PROGRAMS HAVE BEEN STOOD UP BY
GEORGE MENSA THAT HAS THE HOME
OF THE GLOBAL HEALTH AGENDA.
A KEY PART OF THE LEADERSHIP WAS
FORGING INTERNATIONAL
COLLABORATIONS NOT THE LEAST OF
WHICH WAS THE GLOBAL ALLIANCE
FOR GLOBAL DISEASE THAT INCLUDES
A VARIETY OF FUNDERS AROUND THE
WORLD THAT HAVE COALESCED TO
COLLABORATE AROUND STUDIES AND
RESEARCH PROGRAMS ON CHRONIC
DISEASES.
WITH GEORGE'S LEADERSHIP, HE WAS
ABLE TO PUT HYPERTENSION AS A
MAJOR PRIORITY FOR THE COALITION
AND ADDRESSED LUNG DISEASE,
DIABETES AND MENTAL HEALTH AND
OTHER CONCERNS AND CONDITIONS.
TOWARD THAT END, ONE OF THE
STUDIES THE NHLBI FUNDED, THIS
IS AN EXAMPLE RELATED TO
HYPERTENSION INVOLVED A
COMMUNITY WIDE STUDY IN PERU
BASED ON A STEP WEDGE CLUSTER
DESIGN WHERE HOPEFULLY I GOT
THAT RIGHT, GEORGE, THERE WAS A
SUBSTITUTION OF A SALT
SUBSTITUTE AFTER A LOT OF
ENGAGEMENT AND EDUCATION AND
AWARENESS MOVING TO DIFFERENT
VILLAGES AS PART OF THE CLUSTER
DESIGN AND INDEED WAS ABLE TO
DEMONSTRATE THE SALT SUBSTITUTE
REDUCED THE INCIDENTS OF
HYPERTENSION IN THE VILLAGES
ACCORDING TO THE MODELLING THEY
DID BASED ON TIME SEQUENCE AND
CLUSTERING AS WELL NOTICEABLE
DECREASE IN BLOOD PRESSURE
SUGGESTING THE COMMUNITY-WIDE
INTERVENTION COULD HAVE GREAT
IMPACT SIMILARLY, MOVING FROM
CARDIOVASCULAR TO BLOOD
DISORDERS WE SEE AN OPPORTUNITY
TO TRANSLATE WHAT WE KNOW IN
SICKLE CELL DISEASE WE'VE BEEN
BLESSED TO WATCH THE EVER
DECLINING MORTALITY PARTICULARLY
AMONG CHILDREN IN THE LAST 40
YEARS.
IT'S BEEN QUITE SUBSTANTIAL
RELATED IN LARGE PART TO
DIAGNOSIS, NEWBORN SCREENING AND
PROPHYLAXIS AND TRANSFUSIONS,
PNEUMOVAX, ETCETERA, ALL THESE
THINGS THAT CAN HELP REDUCE
CHILDHOOD MORTALITY FROM SICKLE
CELL DISEASE.
AS WE LOOK FORWARD TO CHILDREN
IN THE U.S. EXPERIENCING LONG
SURVIVAL OF CHILDHOOD THIS IS
NOT THE CASE IN OTHER PARTS OF
THE WORLD.
YOU CAN SEE WHERE MOST CHILDREN
WITH SICKLE CELL RESIDE, AFRICA
BEING A LEADING PLACE, WEST
AFRICA IN PARTICULAR WHERE
THERE'S MORE BIRTHS BUT
UNFORTUNATELY YOU CAN ALSO SEE
THE STRIKING DIFFERENCE IN
SICKLE CELL DISEASE AND IN
AFRICA THE RATES ARE 50% TO 80%
OF MORTALITY OF 5-YEAR-OLDS IN
SUB-SAHARAN AFRICA.
THIS IS SOMETHING WE PREVENTED
IN OUR COUNTRY AND BELIEVE WE
CAN DO THAT IN SAHARA AFRICA AS
WELL.
TO THAT END OUR BLOOD DIVISION
LED EFFORTS TO ENGAGE SCIENTISTS
IN AFRICA.
TERRIFIC LEADERS LIKE JULIE
CONNIE AND OTHERS LEADING
NETWORKS BUILDING THAT
CAPABILITY TO DO NEWBORN
SCREENING AND TO CONDUCT
CLINICAL RESEARCH, FORM A
REGISTRY AND CONDUCTING CLINICAL
TRIALS AND DEMONSTRATED THE
CAPABILITY TO ADMINISTER AGENTS
LIKE HYDROXY UREA IN PROTOCOLS
AND ARE CREATING A CONTINENTAL
NETWORK OF INVESTIGATORS AND
CAPABILITIES THAT SHOULD
HOPEFULLY MAKE A DENT IN THAT
CHILDHOOD MORTALITY IN THE NEAR
TERM.
FINALLY, WE HOPE THAT
INFRASTRUCTURE IN WHICH WE
FINALLY TRANSLATE WHAT WE KNOW
WORKS AT THE SETTINGS LIKE
SUB-SAHARAN AFRICA WHERE THEY
WILL INNOVATE CONTEXTUAL
SOLUTIONS THAT EFFECTIVELY
ENABLE THEM TO IDENTIFY WHO HAS
SICKLE CELL THESE AND HOW TO
MORE EFFECTIVELY TREAT THEM IN
THEIR CONTEXT.
WE HOPE THEY'LL ALSO BE THE
LANDING PLACE, THE HOME OF NEW
TECHNOLOGIES THAT CAN BE
CURATIVE.
WE'RE HOPING AND PLANNING AND
INDEED YOU'LL HOPEFULLY SEE A
MANIFEST OF PROGRAMS ENABLE
ADVANCEMENT OF CURATIVE
THERAPIES IN THIS COUNTRY AND
NOT ONLY IN THE CONTEXT YOU
WHERE HAVE SOPHISTICATED
CHILDREN'S HOSPITALS THAT ARE
NEEDED TO HAVE CELL THERAPY,
GENETIC THERAPY FOR SICKLE CELL
DISEASE BUT TO MAKE A
TRANSFORMATIVE TECHNOLOGY LEAP
SUCH THAT WE CAN THINK OF A LESS
TOXIC REGIMENT AND THE ABILITY
TO BUILD GENE EDITING MACHINERY
TO HONE TO TISSUES.
FOR EXAMPLE, HEMATOPOIETIC STEM
CELLS ONE WAY WE ENVISION MAKE A
BLOOD TRANSFUSION WILL BE GIVEN
IN RURAL GEORGIA OR RURAL GHANA
AND THIS IS PART OF OUR AGENDA
FOR THE FUTURE PART OF WHICH
WE'RE DOING IN COLLABORATION
WITH THE GATES FOUNDATION THAT
WE HOPE TO BUILD ON THAT
INFRASTRUCTURE OF TAKING WHAT WE
KNOW WORKS, TAKING SUB-SAHARAN
AFRICA AND DEVELOPING A LEAPFROG
TECHNOLOGY THAT COULD BE
ACTUALLY ACCESSIBLE AND SAFE IN
THAT CONTEXT AS WELL.
THAT'S THE TECHNOLOGY CHALLENGE
WE HOPE TO TAKE ON IN THE NEXT
FIVE YEARS.
PART OF THAT MEANS WE NEED AN
ECO SYSTEM TO MAKE THAT
POSSIBLE.
ACADEMIA, GOVERNMENT, YOU ARE
SISTER AGENCIES LIKE CMS TO
ENSURE WE HAVE FDA AND
REGULATORY AND BIO TECH AS PART
OF THE COMMERCIALIZATION OF
THESE TECHNOLOGIES.
WE'RE ENCOURAGED BY THE PROGRESS
BEING MADE.
WE HOPE TO BUILD A COMMUNITY OF
PRACTICE TO ADVANCE HEART, LUNG
BLOOD RESEARCH, SAVE LIVES
AROUND THE WORLD.
LEVERAGING THIS APPROACH
FOCUSSING ON THE MOST VULNERABLE
COMMUNITIES IN THE U.S., AROUND
THE WORLD WHERE SCIENCE CAN MAKE
A DIFFERENCE AND SAVE LIVES BY
ENGAGING IN COLLABORATORS,
PARTNERSHIPS, COMMUNITIES,
DEVELOPING INFRASTRUCTURE
CAPACITY, TRAINING, TO TACKLE
THE BEST BUYS, THE DISORDERS WE
KNOW WE CAN TREAT IN THESE
CONTEXT TO HAVE THE GREATEST
IMPACT.
WITH THAT I THANK YOU FOR YOUR
ATTENTION.
>> THANK YOU, DR. GIBBONS.
THAT WAS VERY INTERESTING AND I
HOPE THE COUNCIL HAS MAYBE SOME
COMMENTS OR QUESTIONS.
IF YOU DO HAVE COMMENTS OR
QUESTIONS YOU CAN PUT THEM IN
THE CHAT OR RAISE YOUR HAND.
YOU CAN USE THE REACTION BUTTON.
>> THANK YOU, DR. GIBBONS.
THIS HAS BEEN A WHIRLWIND TO SEE
THE BREADTH OF ACTIVITY THE
NHLBI IS PROMOTING AND
SUPPORTING.
IN PARTICULAR I THINK I JUST
WANTED TO OFFER THE POSITIVE
FEEDBACK I'M PLEASED TO SEE
THERE'S A GLOBAL FOCUS AS WELL
BECAUSE WHAT IS HAPPENING AROUND
THE WORLD WILL INFLUENCE US IN
THE UNITED STATES.
IT WAS NICE TO SEE THE GLOBAL
FOCUS AND THE WORK GOING ON IN
EACH OF THE MAJOR DIVISIONS.
>> THANK YOU FOR THAT COMMENT.
>> THERE'S NOTHING LIKE A
PANDEMIC TO REINFORCE HOW
CONNECTED WE ARE.
ALL TE TOPICS, CLIMATE CHANGE,
ETCETERA, REENFORCE THAT
CONNECTIVITY AND WHERE IT'S
CRITICAL.
AS PART OF A HEALTH EQUITY
AGENDA THAT IS GOING TO TAKE ALL
OF TO US CARE FOR ALL OF US
BECAUSE WE'RE ALL IN THIS
TOGETHER.
THANKS FOR THAT, MERCEDES.
>> DOES ANYBODY ELSE HAVE ANY
QUESTION OR SOMETHING THEY WANT
TO BRING TO THE CONVERSATION
BEFORE WE MOVE ON?
>> OKAY.
DR. GIBBONS, I THINK YOU WERE
VERY CLEAR IN YOUR PRESENTATION
SO WE DO HAVE OUR SPEAKER FROM
THE D.I.R. NEXT ON THE AGENDA,
DR. KEMPER IS A SENIOR
INVESTIGATOR AND SECTION CHIEF
AT THE NATIONAL HEART, LUNG AND
BLOOD INSTITUTE AT THE NATIONAL
INSTITUTES OF HEALTH AND SHE IS
ALSO AN ADJUNCT PROFESSOR OF THE
UNIVERSITY OF LUBECK, GERMANY.
HER RESEARCH FOCUSES ON
NON-CANONICAL ROLES OF
PHYSIOLOGY AND DISEASE AND A
RECIPIENT OF AN INVESTIGATOR
TRUST AND MERIT AWARD FOR
EXCELLENCE IN SCIENCE FROM AND
TWO AWARDS IN SCIENCE FROM THE
NHLBI AND AN ELECTED MEMBER OF
THE HENRY KUNKEL SOCIETY AND
SERVES ON A SCIENTIFIC BOARD AND
IS THE CURRENT PRESIDENT OF THE
INTERNATIONAL COUNCILMAN'S
SOCIETY.
TODAY SHE'LL SPEAK TO US ABOUT
LOCATION MATTERS, UNEXPECTED
ROLES FOR HEALTH AND DISEASE.
I HOPE WE CAN ALL WELCOME
DR. KEMPER.
>> THANK YOU, LAURA.
>> CAN EVERYBODY SEE MY SLIDES?
>> YES, PERFECT.
>> I'D LIKE TO THANK THE NHLBI
LEADERSHIP TO FOR INVITING AND
THE COUNCIL FOR COMING AND
LISTENING TO WHAT I'M DOING.
I'VE GIVING AN INTRODUCTION TO
THE WORK AND I'M RELATIVELY SURE
MANY HAVE NOT HEARD OF US AND TO
GIVE AN OVERVIEW OF THE
COMPLEMENT AND INFLAMMATION
RESEARCH SECTION I'M HEADING AND
TO GIVE A SNAPSHOT OF OUR WORK.
WHAT TIME TRYING TO DO IN
BETWEEN IS NOT ONLY SHOWCASE OUR
SCIENCE BUT SHARE HOW WE OPERATE
AS A TEAM AND RESEARCH AND
CLINICAL TEAM AND EMBED US IN
THE NIH WIDE COMMUNITY AND NIH
WIDE MISSION.
MOST HAVE HEARD THE WORD
COMPLIMENT SYSTEM.
IT'S A SYSTEM CIRCULATING IN
YOUR BLOOD AND IT'S ONE OF THE
OLDEST PARTS OF THE IMMUNE
SYSTEM, THE INNATE IMMUNE
SYSTEM.
IT'S CRITICAL TO PROTECT YOU
AGAINST THE VIRUSES AND THERE'S
15 PROTEINS CIRCULATING IN THE
FLUID OR KILLS PATHOGENS BY
ACTIVATION THAT INDUCE THIS
INFLAMMATORY REACTION IN GENERAL
AND CRITICAL TO ADAPTIVE
IMMUNITY.
THE TWO CRITICAL COMPONENTS OF
THE COMPLIMENT SYSTEM ARE HERE.
IT'S A GOOD SYSTEM TO HAVE
FUNCTIONING WELL.
THE COMPLEMENT SYSTEM ALSO HAS A
DARK SIDE.
IF IT'S UNCONTROLLED AND THAT
ACTION SADLY HAPPENS QUITE OFTEN
CAN TURN AGAINST US AND WHAT IT
THEN DOES IS CAUSES PATHOLOGICAL
AND ACUTE AND CHRONIC
INFLAMMATION.
THAT UNDERS IN -- UNDER LIES A
BROAD RANGE OF DISEASE AND
THERE'S ONLY A SMALL LIST OF
REASONS.
IT MEANS WE KNOW FOR DECADES
COMPLEMENTS IS A THERAPEUTIC
TARGET FOR 60 TO 70 YEARS A LOT
OF MONEY AND RESEARCH IN
CLINICAL EFFORTS HAVE GONE TO
DEVELOPING COMPLEMENTIVE
TARGETED EFFORTS AND THE SUPPORT
HAS BEEN RATHER DISAPPOINTING.
HERE TO THE RIGHT WE SEE A
SNAPSHOT OF PUBLICATION IN 2015
WHERE ONLY FOUR COMPLEMENT
TARGETS AND IF I UPDATE IT TO
2022 THERE'S ONLY TWO MORE.
SIX ARE IN THE CLINIC AND FDA
APPROVED FOR COMPLEMENT MEDIATED
DISEASES.
AND ALMOST MORE IMPORTANTLY, THE
DRUGS THAT WE HAVE TODAY ARE
ONLY APPLICABLE TO RARE DISEASE
CONDITION AND SKIN AGE AND
SYNDROME AND SO WHAT WE ARE
LACKING RIGHT NOW IS COMPLEMENT
TARGETED THERAPEUTICS THAT
TARGET BROAD HUMAN DISEASES SUCH
AS ARTHRITIS, ATHEROSCLEROSIS
AND IBD.
IT'S NOT CLEAR TO THE COMMUNITY
WHY WE HAVE BEEN UNSUCCESSFUL
BUT I THINK POSSIBLY OUR WORK AT
THE NIH HAS MAYBE COME UP WITH
AGE EXPLANATION.
WE THINK COMPLEMENT IS LIVER
DERIVED AND CIRCULATES IN BLOOD
AND THERE'S COMPLEMENT MORE IN
CIRCULATION.
I'D LIKE YOU TO TAKE ONE
SNAPSHOT OF THE IDEA OF WHAT
WE'RE DOING HERE AND IT WOULD BE
THIS SLIDE.
WHAT WE HAVE DISCOVERED THAT
WILL EVERY CELL CARRIES IT
COMPLEMENT SYSTEM AND WE CALL
THIS THE COMPLOSOME IS CONCERNED
WITH A SINGLE-CELL METABOLISM
AND CONTROLS CELL SURVIVAL,
HOMEOSTASIS AND FUNCTION.
THE WAS DISCOVERED BY A POST-DOC
IN MY LAB IN COLLABORATION WITH
MY MENTOR AND MARTIN HAS
DISCOVERED THAT HUMAN C3A
POSITIVE T CELL AND THEY CONTAIN
C3 STOREAGES IN LYSOSOMES AND
THAT'S ACTIVATED BY A PROTEASE
AND THE INTRACELLULARLY
GENERATED C3A INDUCES THE MTOR
MACHINERY IN EVERY CELL IN YOUR
CELL AND IT'S REQUIRED TO
SUSTAIN T CELL SURVIVAL AND
WITHOUT THE SYSTEM THEY WILL
DIE.
THAT WAS AN INTERESTING FINDING
BECAUSE 10 YEARS AGO WE DIDN'T
REALLY THINK COMPLEMENT WAS
INTRACELLULARLY AND HAVE A T
CELL SURVIVAL.
IT WENT AGAINST THE GRAIN OF
WHAT WE KNEW ABOUT THE
COMPLEMENT SYSTEM.
HOWEVER, WHEN WE KEPT WORKING ON
THIS SYSTEM, WE KIND OF PUT IT A
LITTLE BIT BETTER INTO THE
PICTURE OF WHAT PEOPLE USUALLY
THOUGHT ABOUT COMPLEMENT BECAUSE
IT IS ACTUALLY ALSO T CELLS'
DEFENSE SYSTEM IN THE PRESENCE
OF DANGER, THE SYSTEM IS A
LITTLE BIT LIKE A LOADED GUN
FLIPS TO THE OUTSIDE OF THE T
CELL WHERE THE OTHER PORTION OF
C3B ENGAGES THE RECEPTOR, CD426
AND IT'S A HUMAN SPECIFIC
MOLECULE NOT EXPRESSED IN MICE.
THERE'S NO SMALL ANIMAL MODEL TO
LOOK AT THIS THIS IS A HUMAN
SPECIFIC PATHWAY.
THE CD ENGAGEMENT HAS THE
CANONICAL CYTOKINE TO INDUCE OR
DENOTE TH1 RESPONSES.
INTERESTINGLY ENOUGH, COMING
FULL CYCLE BACK HERE THE CD46
ENGAGEMENT DRIVES RESPONSE BUT
ALSO MOVES INTO A STATE
IMPORTANT TO PREVENT TISSUE
MORPHOLOGY AND DOES SO BY
CO-INDUCING THE INFLAMMATORY
CYTOKINE IN TH CELLS.
WE HAVE SHOWN WITH
COLLABORATORS, IF YOU DON'T HAVE
THIS SYSTEM C3 THEY CANNOT MOUNT
RESPONSES AND SUFFER FROM
RECURRENT VIRAL INFECTIONS OF
THE UPPER RESPIRATORY.
HOWEVER, IF THE SYSTEM IS
AUGMENTED IF THE SYSTEM PRODUCES
TOO MUCH CD3 AND GET TOO MUCH
CD46 ENGAGEMENT YOU ARE GET
RESPONSES CONTRIBUTE TO THE
ARTHRITIS, SCLERO DERMA-AND
ORGAN REJECTION WE HAVE KNOWN
IT'S AN INTERESTING SYSTEM AND
THERE'S A HIGH PROBABILITY AND
WE HAVE SHOWN THAT IF WE TAKE
THE T CELLS FROM PATIENTS
SUFFERING FROM THESE STATES OF
AUTOIMMUNITY FROM THE LOCATION
OF INFLAMMATION FOR EXAMPLE, T
CELLS FROM THE INFLAMED JOINT OF
PATIENTS WITH ARTHRITIS AND
CULTURE THEM IN VIVO AND EX VIVO
AND WHAT DRIVES THE SYSTEM WE
CAN COMPLETELY NORMALIZE
HYPERACTIVE TH1 RESPONSE.
THIS WAS AN EXCITING POINT.
THINGS GOT MORE INTERESTING WHEN
WE TRIED TO UNDERSTAND HOW
EXACTLY IS THIS CAREER
COMPLEMENT CD46 CONTROLLING CH1
BIOLOGY.
WE EXPECT THE IT CONTROLS GENE
TRANSCRIPTION ON THAT LEVEL BUT
WHAT WE NOTED USING T CELLS FROM
THESE PATIENTS CD46 DOES THREE
CORE SIGNALLING INDUCTION
PATHWAYS.
FIRST ONE IS IT INDUCES THE GENE
EXPRESSION OF GENES AND CODED
PROTEINS CRITICAL TO ALLOW THE
ACTIVATED T CELL.
FOR EXAMPLE, A BROAD RANGE.
AT THE SAME TIME, CD46 INDUCE
THE SHUNT OF THE MTOR IN THE
METABOLIC MACHINERY THAT SENSES
NUTRIENTS IN THE CELL TO THE
LYSOSOMES AND THESE TOGETHER
DRIVE THE INFECTION.
T CELLS ALSO CONTAIN THE SYSTEM
CD46 ACTIVATED THE SYSTEM WHICH
THEN ENGAGES THE CELL INTRINSIC
OR SECOND SYSTEM THE INFLAMOSOME
DRIVING PRODUCTION AND
CONTROLLED TH1 RESPONSES.
IN A SIMILAR VEIN, CD46 CONTROLS
THE SHUT DOWN BY METABOLIC
REPROGRAMMING AND HERE IT
INDUCES CHOLESTEROL EFFLUX AND
INDUCES IL01 AND TH1
CONTRACTION.
THERE'S A SECOND ARM OF
COMPLEMENT AND RECEPTOR 2 THAT
ALSO AN IN AN INTRINSIC FASHION
BLOCKS THE ACTIVATION.
WHAT LAURA HASN'T TOLD YOU IS I
MOVED MY LAB AFTER THESE
DISCOVERIES IN 2017 TO NHLBI.
WHEN I JOINED THE FACULTY HERE,
WE KNEW THAT NORMAL BIOLOGY IS
DEPENDENT ON AN INTRINSIC
COMPLOSOME, THAT IT WORKS IN
COLLABORATION WITH OTHER ANCIENT
SYSTEMS AND IT'S CRITICAL AND
BECAUSE IT'S NOT EXPRESSED IT'S
THE HUMAN SPECIFIC SYSTEM.
WE ALSO KNEW THAT PERTURBATION
IN THE CELL INVASIVE SYSTEM
CONTRIBUTE TO HYPER AND
HYPOACTIVITY AND PERTURBATIONS
AFFECT THE MODEL.
WHAT WE DID WAS WHEN WE MOVED
HERE WE STARTED DEVELOPING A
BIGGER PROGRAM.
WE WANTED TO UNDERSTAND THE
FUNCTION OF THE COMPLOSOME WITH
REGARDS TO OTHER ARMS OF CELL
BIOLOGY AND WORKING ON STRESS
SENSING AND DNR ORGANIZATION.
I'LL SHOW A FEW TOWARDS THE END
OF MY PRESENTATION.
IMPORTANTLY, WE NEED TO
UNDERSTAND HOW THE SYSTEM
REGULATES BECAUSE YOU'VE SEEN IF
IT'S DISREGULATED AND CAUSES
DISEASE.
FOR THIS WE WENT INTO TISSUE
BIOLOGY AND DIFFERENCE DISEASES
AND TRIED TO UNDERSTAND WHERE IT
OCCURS OR REGULATED AND IF
REGULATION AND OCCURRENCE IS THE
SAME IN ALL AND THE ULTIMATE
GOAL TO UNDERSTAND TO WHAT
DISEASE DOES DYSFUNCTION OF THE
SYSTEM CONTRIBUTE AND DEVELOP
NEW PRE-CLINICALAL MODELS AND
THERAPEUTIC MODULATION.
THIS IS A SNAPSHOT OF OUR OVER
ARCHING RESEARCH PROGRAM.
TO ADDRESS THESE QUESTIONS IT
LOOKS PRETTY COMPLEX.
WE USUALLY CHOP DOWN THINGS INTO
SMALLER CHUNKS WE CAN HANDLE
QUITE WELL.
WHAT WE DO NORMALLY IS WE
ACTUALLY TRY TO ADDRESS TWO
IMPORTANT AND SIMPLE QUESTIONS.
THE ANSWERS ARE NOT SIMPLE BUT
THE QUESTIONS ARE SIMPLE.
HOW DOES THE COMPLOSOME FUNCTION
AND REGULATE?
ONE OF THE IMMINENT QUESTIONS
WAS I SHOWED YOU WE HAD
DISCOVERED THAT IN CD4 POSITIVE
T CELLS.
IS THE SYSTEM CD4 T CELL
SPECIFIC OR DOES IT OCCUR IN
OTHER IMMUNE CELLS?
I'M SHOWING YOU A LITTLE BIT OF
THE SUMMARY OF OUR RESEARCH IN
THE LAST FOUR YEARS.
WE FIRST TRIED TO FIND OUT IS
THIS SYSTEM ALSO OPERATIVE AND
THE OTHER SUB TYPE, CD8 T CELLS
THAT YOU NEED TO FIGHT VIRAL
INFECTIONS AND THE SYSTEM
OPERATES IN A SIMILAR FASHION
WITH CD8 POSITIVE T CELLS IS
REQUIRED FOR NORMAL ACTIVATION
AND NEEDED TO PROTECT YOU
AGAINST RECURRENT INFECTIONS.
WE COLLABORATED WITH NAIMS AND
WHAT WAS FOUND IS THE COMPLOSOME
PERTURBATION IN PATIENTS WITH
LUPUS CROSS-CONNECTS AND
CROSS-TALKS WITH THE EXTRA
CELLULAR COMPLIMENT SYSTEM AND
PERTURBATIONS CONTRIBUTE TO THE
PHENOTYPE FORMATION UNDERLYING
THIS.
TOGETHER WITH SOME RESEARCHERS
ACROSS OTHER INSTITUTES, WE HAVE
FOUND THE SYSTEM IS ALSO REALLY
OPEN TO MONOCYTES AND
MACROPHAGES AND DENDRITIC CELLS
AND IF THEY MAY NOT BE ABLE TO
FIGHT PRO-INFLAMMATORY STATES
AND PATIENT WHO'S CAN'T ENGAGE
IN THIS SYSTEM SUFFER FROM
IMMUNE DEFICIENCIES.
WHAT WE'RE TRYING TO DO IS MOVE
INTO THE SPIRIT OF NHLBI AND
UNDERSTAND CARDIOVASCULAR
DISEASE BETTER OUR MOST RECENT
FINDING IS THIS INTRACELLULAR
SYSTEM AND MONOCYTES AND
MACROPHAGES ARE NOW DRIVEN BY
INFLAMMATION.
ACTIVITY IN THE MONOCYTES LEADS
TO THE DYSREGULATION OF
MITOCHONDRIA AND TRANSPORT CHAIN
AND TO THE HYPERACTIVE STATE
MYELOID CELLS IN ATHEROSCLEROSIS
AND THERE'S A PAPER SHOWING THAT
SYSTEM WHICH IS DISREGULATED IN
ATHEROSCLEROTIC DISEASE PROTECTS
YOU AGAINST CANDIDIASIS AND
THERE'S DISEASES OF AUTOIMMUNITY
AND CARDIOVASCULAR DISEASE.
WE KNOW AND CONSTITUENT WE HAVE
BEEN ABLE TO NORMALIZE
SUCCESSFULLY C3 OR C5 INCREASES
IN T CELLS AND MONOCYTES AND
MACRO PHAGES IN VITRO AND WE
HAVE DEVELOPED WHAT HAS PASSED
TOXICOLOGY TESTS IN THE ANIMALS
AND MOVING TO TESTING THIS
COMPOUND IN CARDIOVASCULAR
DISEASE MODELS FOR ACTIVITY IN
THE INTRACELLULAR COMPLEMENT
DURING THESE DISEASE.
TACKLING AN INTRACELLULAR TARGET
WHAT WE'RE DOING IS WE'RE TRYING
TO UNDERSTAND THE NOVEL BIOLOGY
OF THE SYSTEM AND WE'RE
PARTICULARLY INTERESTED IN WHAT
ARE THE CELL REGULATORS OF C3
AND C5 TRANSCRIPTION OF IMMUNE
CELLS BECAUSE THE CELLS TARGET
AND I THINK WE HAVE DONE IT
SUCCESSFULLY AND I'D LIKE TO
SHARE WITH YOU HOW SOMETIMES AN
UNUSUAL FINDING OR CRITIQUE IN
THE FIELD CAN LEAD TO
DISCOVERIES.
SO WHAT HAPPENED IS WE RECEIVED
A LOT OF PHONE CALLS FROM OTHER
RESEARCHERS THAT SAID CLAUDIA,
WE CAN'T SEE A LOT OF COMPLEMENT
ACTIVITY IN CELLS AND
CIRCULATION.
I WAS WITH MY TEAM DURING A
BRAIN STORMING SYSTEM AND
WONDERING WHY THAT MIGHT BE AND
WE THOUGHT THE ACTION FOR ANY
DISEASE IS IN THE TISSUE.
SO WE WERE HYPOTHESIZING MAYBE
THE SYSTEM IS MORE IMPORTANT IN
TISSUE CELLS.
SO WHAT WE DID WITH
COLLABORATORS WE SOURCED
PUBLICLY AVAILABLE DATA WHERE T
CELLS OR IMMUSOLATED HUMAN SPLE
AND TISSUE OF CD4 T CELLS AND
LOOKED AT CIRCULATING VERSUS
RESIDENT CELLS AND THIS PANEL I
RECEIVED IN MY MAILBOX TWO DAYS
LATER.
I SAID NO, NO I DIDN'T WANT KNOW
THE COMPLEMENT EXPRESSION
PROFILE, I WANTED TO KNOW THE
WHOLE EXPRESSION PROFILE.
THEY SAID THIS IS THE UNBIASSED
DATA AND YOU CAN SEE THE IMMUNE
CELLS AND TISSUES.
THIS IS NOT ONLY THE CASE FOR
CD4 POSITIVE T CELLS BUT FOR CD8
T CELLS AND MYELOID CELLS AND
WHEN YOU GO TO THE EXPRESSION OR
COMPLEMENT LIKE I PROPOSED IN
THE BEGINNING, IT'S THE FULL
COMPLEMENT OF THE EXPRESSED
CELLS.
BASED ON THE INITIAL FINDING WE
FOUND THAT THE INTEGRIN IN FA1
IS THE MASTER INDUCER OF THE
COMPLEMENT CD3 COMPONENT WHY THE
CELLS MOVE INTO THE TISSUE.
THAT ALLOWED US TO INTEGRATE THE
SIMPLISTIC COMPLOSOME IN CONTROL
MORE INTO THE BODY AND MORE INTO
THE TISSUE.
SO WE KNOW THAT THE COMPLOSOME
MOVE TO THE TISSUE AND THIS IS
ALWAYS ENGAGED DURING THE
DIABETES TISSUES WHICH NOW NEEDS
TO TRANSCRIPTION WE CALL THIS
CD3 AND THE EFFECTER FUNCTION
AND HERE YOU HAVE HIGH
COMPLOSOME ACTIVATION AND THE
DRIVING DOWN STREAM TOWARDS T
CELL MYELOID CELL INFECTOR
FUNCTION.
IMPORTANTLY, THE SYSTEM ALSO IS
IMPORTANT AND ENGAGED ONCE THE
DANGER AND STOP BEING AN
EFFECTER CELL TO PREVENT
MORPHOLOGY.
YOU SEE THE COMPLOSOME IN ALL
LIFE CYCLE STAGES OF IMMUNE
CELLS BUT LOOKS A LITTLE BIT
DIFFERENT AND DOES SOMETHING
DIFFERENT DURING ALL THE STAGES.
MY LAB IS PARTICULARLY
INTERESTED IN UNDERSTANDING THE
TRANSITION OF THIS STATE AND THE
EFFECTER TISSUE TO THE
CONTRACTION TISSUE.
AND IF WE CAN UNDERSTAND THAT
AND MONTHLY LATE THAT WE'LL HAVE
A WAY TO CONTROL IMMUNITY AND
CANCER VERSUS CHRONIC INFECTION.
IMPORTANTLY, WITH THE EXPANDING
UNDERSTANDING THAT THE
COMPLOSOME IS REALLY QUITE
IMPORTANT ACROSS THE IMMUNE CELL
ACTIVITY IT'S NOT SOMETHING VERY
EXCITING OUTSIDE OF THIS, LARGE
PROPORTIONS OF THE SCIENTIFIC
COMMUNITY AND ALSO COMMISSIONS
ARE NOW STARTING TO BUY INTO THE
SYSTEM AND WE KNOW NOW THAT THIS
IS NOT JUST AN IMMUNE CELL
SPECIFIC PHENOMENA BUT THE
COMPLOSOME OPERATES IN A CLINIC
ROLE AND PANCREATIC CELLS AND
INTESTINAL EPITHELIAL CELLS TO
AND IS IMPORTANT AND DISEASE CAN
SPREAD AND WE HAVE HELPED OTHER
COLLABORATORS FIND A ROLE FOR
THE COMPLOSOME IN COLON CANCER
OR IN THE HIGH INFLAMMATORY
STATE THE COMPLEMENT SYSTEM PUTS
IN THE APPLICATION.
THIS IS WHERE WE STAND TODAY AND
I'M SHARING IN THE LAST SEVEN OR
EIGHT MINUTES JUST SOME
SNAPSHOTS AND DIRECTION IN WHICH
WE'RE GOING.
THIS IS MY TEAM RIGHT NOW.
I HAVE TWO STAFF SCIENTISTS AND
POST-DOCS AND ONE VISITING
CLINICAL FELLOW AND TWO Ph.D.
STUDENTS AND ONE JOINING THE
LAB.
I DO ACTUALLY THINK THAT MY LAB
IS A GREAT PLACE NOT JUST FOR
DOING SCIENCE BUT FOR TRAINING
PEOPLE NOR NEXT GENERATION OF
BASIC OR CLINICAL BIO MEDICAL
RESEARCH.
I THINK WE HAVE CREATED AN
IMPORTANT NICHE OF ADAPTIVE
IMMUNITY.
MEANING THERE'S SOMETHING FOR
EVERYBODY INTERESTED IN CERTAIN
ASPECTS OF IMMUNE BIOLOGY.
THEY'RE VERY INTERDISCIPLINARY.
WE DO HAVE FOCUS BUT WE'RE STILL
VERY INTERDISCIPLINARY AND
NETWORKING HEAVY IS GOOD FOR OUR
TEAMS AND STUDENTS.
THEY NETWORK AND MEET PEOPLE.
WE LIKE USING CUTTING-EDGE
TECHNOLOGIES YOU HEARD FROM GARY
GIBBONS GIVEN THE STRENGTH OF
NIDR AND CONVEY OUR FINDING TO
TRANSLATIONAL ASPECT.
WE'RE FOCUSSING ON TWO MAIN
AREAS, AND I'LL SHARE WITH YOU
WHY WE KEEP WORKING ON THESE.
WE'RE MOVING INTO A NEW AREA.
THE COMPLOSOME AND IMMUNITY AND
INFLAMMATION FROM ALL THE WORK
I'VE SHARED.
JUST A QUICK OVERVIEW.
AND WE HAVE A POST-DOC WHO
JOINED IN NOVEMBER 2019.
JUST WHEN HE WAS READY TO GET
BACK TO WORK, COVID CAME AND WE
MOVED TO A SHUT DOWN SYSTEM AND
JACK WAS INTERESTED IB DEFINING
THE GENETIC PROFILES THAT DRIVE
TH1 INFECTION AND CONTRACTION IS
ALSO REALLY GOOD COMPUTATIONAL
BIOLOGIST.
SO WHAT JACK DECIDED TO DO WHILE
HE WAS SITTING AT HOME AND
COULDN'T BE AT THE BENCH,
THERE'S A GOOD PROGRAM MISSING
RIGHT NOW TO MY SINGLE CELL SEQ
DATA AND WHAT JACK DID WAS WROTE
A PROGRAM AND DEVELOPED A NEW
TOOL.
HE SUBMITTED AND HAS BEEN
REVISED AND RESUBMITTED THIS
WEEK AND ASKED EVERYBODY TO MINE
OUR RNA SEQ DATA AND NOT JUST ON
A SINGLE GENE.
HE USES THIS NEW TOOL NOW TO
ASSESS THE GENETIC GENE
EXPRESSION PROFILES THAT T CELLS
GO THROUGH WHEN THEY MOVE TO THE
IL10 CONTRACTING PHASE.
HERE WE FOUND SOMETHING REALLY
INTERESTING.
DOWN HERE IN THE GRAY ZONE ARE T
CELLS THAT ARE NOT MOVING INTO A
TH1 PLACE, TH172 CELLS BUT WHEN
WE LOOK AT THE GENE EXPRESSION
BETWEEN THE GROUPS THEY ALL
CLUSTERED IN THE SAME AREA
MEANING THEY REALLY DO NOT HAVE
MUCH DIFFERENT OR DON'T DISPLAY
DRAMATIC DIFFERENT EXPRESSION OF
GENETICS.
I'M NOT GOING INTO THE AREA BUT
WHAT WE NOW FOUND IS THIS
TRANSITION PHASE IS NOT
REGULATED ON THE TRANSCRIPTION.
IT'S ACTUALLY REGULATED ON THE
TRANSLATIONAL SIDE.
WHAT JACK HAS DONE HAS ANALYZED
PROTEIN EXPRESSION PROFILING IN
THESE CELLS AND FOUND A BATTERY
OF NEW PROTEINS WHICH HAVE
PREVIOUSLY NOT BEEN DESCRIBED TO
BE EXPRESSED IN T CELLS.
NOW IN THE SAME VEIN, WE'RE
WORKING ON OTHER METABOLIC
PATHWAYS TO TIP THE BALANCE
BETWEEN TH1 INDUCTION AND
CONTRACTION AND WAS FOUND THAT T
CELLS AND THE COMPLOSOME PRODUCE
WHAT HAS NOT BEEN DESCRIBED YET
AND THE CONTROL BALANCE BETWEEN
PRODUCTION TIPS THE BALANCE
BETWEEN TH1 PRODUCTION AND
REDUCTION.
HE DEVELOPED A MOUSE MODEL AND
DISSECTING THIS NOW IN
ANTI-INFLAMMATORY DISEASES AND
HE HAS SHOWN THE T CELLS THAT
WAS DISPUTED FOR A LONG TIME AND
IS WORKING THE ARGININE
DEFICIENT LINES IN PATIENTS
WHERE THEY NOT TIP THE BALANCE
TO IL6 CONTRACTION AND LOOKING
AT THE TISSUE PATHOLOGY VERSUS
TISSUE PROTECTION.
AND OTHERS ARE WORKING ON A SUB
2 SYSTEM AND KNOW MOVING TO AN
ANIMAL MODEL FOR MULTIPLE
SCLEROSIS AND ALSO IDENTIFIED A
COMPLEMENT LIKE PROTEIN AND
FOUND THAT THAT PROTEIN CONTROLS
THE DEVELOPMENT OF TH1 VERSUS
TH17 CELLS IN VIVO.
MEMORY RESPONSES ARE IMPORTANT
AND THERE'S VIRTUALLY NOTHING
KNOWN IN THE COMPLOSOME IN TH1
MEMORY RESPONSES AND THEY'VE
BEEN LOOKING AT THIS THE LAST
FIVE YEARS.
CD46.
SOME PEOPLE ARGUE IS A DIFFERENT
AREA FOR RESEARCH BECAUSE WE
DON'T A SMALL ANIMAL MODEL BUT
WE'RE KEEN ON DISSECTING THE
BIOLOGICAL FUNCTIONS OF THE
PROTEIN BECAUSE WE THINK HES
UTTERLY IMPORTANT TO HUMAN
BIOLOGY.
MUTATIONS IN THIS GENE ARE
ASSOCIATED WITH INFECTIOUS AND
INFLAMMATORY DISEASES PART OF
THE SNIPS IN THIS MODEL ARE
ASSOCIATED WITH DEVELOPMENT OF
MENTAL DISEASE, SCHIZOPHRENIA
AND CANCER AND INTERESTED IN THE
SIGNALLING PATHWAYS OF THE
MOLECULE AND UNDERSTANDING HOW
TO APPLY IT TO CANCER AND CAR T
CELL THERAPY.
THIS IS ALL DEVELOPED BY JOHN
ATKINS IN 1986 AND IMPORTANT TO
KNOW THAT IT'S EXPRESSED IN
DIFFERENT ISO FORMS AND CAN
EXPRESS TWO DIFFERENT
CYTOPLASMIC DOMAINS AND WHEN
EXPRESSED IN THE SURFACE THROUGH
CB3 OR SOME PATHOGENS THAT USE
CD46 AS A RECEPTOR AND WHEN
MOVED TO THE NUCLEUS AND THIS IS
REALLY IMPORTANT TO INDUCE THE
SIGNALLING ACTIVITY OF CD46
HOWEVER, NONE CONTAIN A DNA
BINDING SO THEY CANNOT FUNCTION
AS TRANSCRIPTION FACTORS
THEMSELVES.
SO TWO TALENTED POST-DOCS IN THE
LAB DECIDED TO TACKLE AND
DISSECT ON THE MOLECULAR LEVEL
HOW THE ACTION WOULD INDUCE TH1
RESPONSE.
AND LOOKING AT THE CYTOPLASM ON
ITS WAY TO THE NUCLEUS AND THE
T1 PROBABLY INTERACTS WITH
TRANSCRIPTION FACTORS AND THIS
CONTROLS THE ACTIVATION.
SO SHE STARTED THIS PROJECT BY A
SIMPLE RNA SEQ OR CUT AND RUN
TECHNOLOGY TO IDENTIFY
TRANSCRIPTION FACTORS THAT
INTERACT DIRECTLY AND USING THIS
METHOD SHE HAS FOUND TWO TWO
TRANSCRIPTERS INTERACT.
AND USING RNA SEQ AND
MICROSCOPY, SHE HAS FOUND THE
INTERACTI
INTERACTION NOT ONLY DRIVES THE
EXPRESSION OF GENES BUT T1 ALSO
INDUCES THE HOMO MULTIMERIZATION
AND SERVES PROMOTERS AND THE
SYSTEM CONTROLS TH1 INDUCTION.
MEANING CD46 IS DIRECTLY
INVOLVED IN CHROMATIN
REMODELLING.
MY SECOND FINAL DATA SET NOT
ENTIRELY CONVINCED ME WE SHOULD
TRY TO MAKE OUR STRIDES TOWARDS
DEVELOPING AN IN VIVO MODEL TO
UNDERSTAND THIS AND CONVINCED ME
TO START WORKING ON THE CD46 DE
EFFICIENT ZEBRAFISH AND EXPRESS
THE CD46 AND TOGETHER WITH
COLLABORATORS AND THE FACILITY
OF NHLBI, WHAT WE HAVE DONE IS
GENERATED THE CD46 DEFICIENCY
AND WHAT YOU CAN SEE THIS IS THE
FISH THAT DOES NOT EXPRESS THE
CD46 GENE ANYMORE AND HERE'S
WILD TYPE ON HETEROZYGOUS FISH
AND YOU CAN SEE CLEARLY RIGHT
AWAY THE FISH IS VERY SIMPLE.
INDEED THE FISH HAS A DRAMATIC
PHENOTYPE, SIGNIFICANTLY
SMALLER, FISH DYING AT 4 MONTHS
OF AGE AND HAVE AN OVER ALL
GLYCOLYSIS FITTING NICELY WITH
OUR SCREEN AND CD46 IS A MASTER
REGULATOR OF THE METABOLISM AND
THE FEWER FISH DEVELOPED
COGNITIVE MYOPATHY.
WE DON'T KNOW YET THE REASON AND
WE'RE WORKING WITH COLLABORATORS
ON TRYING TO POINT OUT WHAT GOES
WRONG WITH THE FISH TO TARGET
MYOPATHY.
MY LAST DATA SLIDE AND A NEW
POST-DOC IN OUR LAB AND OUR
STUDENT FROM ARE REALLY
INTERESTED IN THE VASCULAR
SYSTEM AND THE SYSTEM IN THE
BRAIN AND TOGETHER WITH THE
SUPERV
SUPERVISORS AND OTHERS CONVINCED
ME WE SHOULD EMBARK IN
UNDERSTANDING THE COMPLEMENT
SYSTEM IN THIS UNUSUAL PATIENT
AND WHAT THEY HAVE FUND SO FAR
AND WHEN THEY KNOCKOUT THE C3 IN
MYELOID CELLS IN THE BRAIN, THE
BRAIN OF MICE CANNOT FORM
IMMUNOLOGIC CELL INTERACTION AND
COMMUNICATION AND CANNOT CLEAR
THAT.
WHAT I HOPE I HAVE DONE BY THIS
A LITTLE BIT OF A TOUR OF FORCE,
I KNOW THAT, BUT CONVINCED YOU
THE FUTURE'S BRIGHT, COMPLEMENT
IS NOT THE MOST BORING START OF
IMMUNITY AND THERE'S A LOT OF
SURPRISES IN STORE.
ALSO THE DISCOVERY OF THE
INTRACELLULAR COMPLEMENT SYSTEM
MAY EXPLAIN WHY WE HAVEN'T BEEN
AS SUCCESSFUL AS WE SHOULD HAVE
BEEN TARGETING THE SYSTEM.
AND WE WOULD PROPOSE THAT
THINKING ABOUT THE INTRACELLULAR
SYSTEM POSSIBLY IN COMBINATION
DEPENDING ON THE DISEASE OF THE
DISEASE STATE MAY BE A WAY TO
CHECK ON THE SYSTEM
THERAPEUTICALLY AND I'M OF THE
CONVICTION DIR CAN DO THIS AND
I'D LIKE TO LEAVE YOU HERE WITH
THE NAMES OF ALL THE PEOPLE THAT
HAVE AND ARE HELPING US IN
DISSECT
DISSECTING THIS AND IT TAKES A
VILLAGE TO DO GOOD SCIENCE.
I'M HAPPY TO ANSWER QUESTIONS
YOU MIGHT HAVE.
>> THANK YOU, DR. KEMPER.
DOES ANYBODY HAVE ANY QUESTIONS
OR COMMENTS?
YOU CAN PUT THEM IN THE CHAT OR
YOU CAN RAISE YOUR HAND.
DR. GIBBONS THINKS YOUR WORK IS
SCHOOL AND WHAT IS KNOWN ABOUT
ANCESTRY VARIATION OF CD46?
>> I AVOIDED THAT.
THERE'S THE PATHOGEN RECEPTOR
AND FOR A LOT OF DISEASES
THERE'S ADENOVIRUS AND GENE
THERAPY AND MEASLES VIRUS AND
THERE'S A SPECIFIC EXPRESSION
PROFILE IN CD46 ISO FORM
EXPRESSION PROFILE AND PEOPLE
HAVE DESPERATELY TRIED TO
CORRELATE EXPRESSION PROFILES
AND ANCESTRY OF CD46 WITH
DISEASE ASSOCIATION OR DISEASE
SEVERITY ASSOCIATION.
IT HASN'T WORKED VERY WELL.
I THINK ONE REASON IS BECAUSE
IT'S COMPLICATED.
AND THERE'S A PROCESS.
SIMILARLY ON THE HUMAN HEALTH
LEVEL, WE THINK MAYBE RODENTS
MAY HAVE KICKED OUT THE MODEL
BECAUSE IT WAS TARGETED BY
PATHOGENS.
I CAN'T GIVE YOU A DEFINITIVE
ANSWER TO YOUR QUESTION BECAUSE
I THINK WE NEED TO LEARN MORE TO
COME BACK FULL CIRCLE AND PROBE
WHAT YOU JUST ASKED ME TO DO.
THIS IS MORE INTERESTING THAN
WHEN THEY TRIED TO TEACH ME THIS
IN SCHOOL.
>> THAT'S WHAT WE THINK TOO.
>> DR. SCHOT.
>> SINCE YOU DID YOUR PROFILING
ON RESIDENT LUNG IMMUNE CELLS
AND THERE'S BEEN A HUGE AMOUNT
OF INTEREST IN THE COAGULATION
PATHWAY AND COMPLEMENT PATHWAY
IN ARDS, SPECIFICALLY
COVID-RELATED ARDS.
HAVE YOU LOOKED AT WHETHER THE
PATHWAY IS UPREGULATED AND
DYSFUNCTIONAL IN COVID-RELATED
LUNG INJURY AND THOUGHTS ON
THAT.
>> WE HAVE DONE THAT AND
PUBLISHED IN LINE WITH THE
INTRACELLULAR COMPLEMENT.
WE HAVE SHOWN WITH A COLLABORATE
ERRORSS -- COLLABORATORS AND
SARS COV2 ACTIVATES THE TYPE 2
CELLS THAT THIS INTRACELLULAR C3
ACTIVATION CHANGE THE BEHAVIOR
AND SPILLS TO THE OUTSIDE AND
INSTRUCT THE IMMUNE CELLS TO BE
MORE INFLAMMATORY.
WE HAD PROPOSED VERY CAREFULLY
THAT POSSIBLY A COMBINATION AND
WE COULD REMEDY THAT IN EX VIVO
ORGANOIDS AND WE'RE EXCITED
ABOUT THIS AND POSSIBLY DAMP
ENNING THIS IN ACUTE LUNG
INFLAMMATION MAY BE THE WAY TO
GO.
>> AND YOU'RE TELLING ME I NEED
TO DO A BETTER JOB SEARCHING THE
LITERATURE AND READING.
>> WE CAN'T DO EVERYTHING.
THERE'S SO MUCH OUT THERE
SPECIFICALLY WITH COVID.
>> THANK YOU.
>> WE HAVE A COMMENT FROM GOOD
GILLETTE.
DO YOU WANT TO SAY WHAT YOU HAD
TO SAY?
>> I'M AMAZED AT WHAT YOU'RE
DOING?
WHERE THIS?
IT SEEMS TO ME THIS HAS THE
POTENTIAL NOT ONLY TO BE
INVOLVED IN INFECTIOUS DISEASE
AND AUTOIMMUNE DISORDER WE'RE
FAR FROM UNDERSTANDING.
>> THIS IS MY FORTE.
I STARTED WITH AUTOIMMUNE
DISEASE AND THE WORK WAS DRIVEN
BY THE PANDEMIC AND COMPLEMENT
AND BACK TO AUTOIMMUNITY AND THE
FINDINGS AND COX INHIBITERS HAVE
INTERESTING FINDINGS WITH REGARD
TO T CELL AND THERE'S TH1
RESPONSES.
NOW, THIS IS MY FORTE,
AUTOIMMUNE DISEASES AND WE'RE
WORKING ON THIS WHICH LEADS US
TO CANCER BECAUSE
ANTI-INFLAMMATORY RESPONSE IS
ALSO AT THE HEART OF MANY
CANCERS AND AUTOIMMUNITY AND
MOVING CAREFULLY TO ONE OF TWO
DIRECTIONS AND THAT'S IT.
I'M AN AUTOIMMUNOLOGIST.
>> I DON'T SEE OTHER QUESTIONS
OR COMMENTS IN THE CHAT AND
DR. KEMPER I'LL SEND YOU OFF
WITH A ROUND OF VIRTUAL
APPLAUSE.
I THINK IT WAS A FANTASTIC
SEMINAR AND APPRECIATE YOU
SHARING THAT INFORMATION TODAY
WITH US.
IT WAS GREAT TO HAVE YOU.
>> THANK YOU VERY MUCH.
>> ALL RIGHT.
SO WE ARE NOT READY YET TO START
THE NEXT ITEM ON THE AGENDA
BECAUSE WE'RE A LITTLE BIT AHEAD
OF SCHEDULE AND THE DECISION
LENS GROUP ISN'T HERE YET SO I
THINK PERHAPS WHAT WE'LL DO IS
TAKE A 10-MINUTE BREAK
WELCOME BACK AFTER THE BREAK,
EVERYBODY.
WE HAVE OUR DECISION LENS FOLKS
HERE SO WE'RE GOING TO GO INTO
THE NEXT PART OF OUR AGENDA.
IT'S ACTUALLY THE FINAL AGENDA
ITEM OF TODAY'S MEETING WHICH IS
VOTING ON THE CONCEPT SO WE HAVE
AN IDEA ABOUT WHAT KIND OF
ADVICE YOU THINK WE SHOULD
CONSIDER.
BUT BEFORE WE PROCEED WE HAVE A
FEW REMINDERS.
WHEN ADDRESSING MEETING CONCEPT
COMMENTS RELATED TO SCIENTIFIC
COMMENTS PLEASE ADDRESS ALL THE
PANELISTS NOT THE HOST.
THAT'S WHEN YOU'RE PUTTING
THINGS IN THE CHAT.
DON'T ADDRESS ALL THE PANELISTS,
DO ADDRESS ALL THE PANELISTS,
DON'T ADDRESS THE HOST BECAUSE
IF YOU WRITE TO THE HOST,
EVERYBODY ELSE WON'T BE ABLE TO
SEE IT.
IF YOU ARE ENCOUNTERING ZOOM
TECHNICAL ISSUES CONTACT THE
I.T. FOLKS THEY'RE ONLINE AND
READY TO ASSIST YOU AND DON'T
SEND IT TO THE ZOOM TEAM.
SIMILARLY THOUGH FOR DECISION
LENS ISSUES DON'T GO TO THE I.T.
FOLKS BECAUSE THEY HAVE TO TO
THE DECISION LENS
REPRESENTATIVES.
PAT WILL PROVIDE THE LIVE DEMO
AND TECH SUPPORT AND PROVIDE
PASSWORD RESETS AND LOGIN ISSUES
AND HELP YOU WITH DECISION LENS
NAVIGATION AND WE HAVE BACKUP
SUPPORT FOR PAT AND WILL FORWARD
MORE TO THE DECISION LENS TECH
SUPPORT.
THE TECH SUPPORT E-MAIL
ADDRESSES WILL BE ADDED TO THE
CHAT FOR THOSE WHO NEED
ASSISTANCE AND IT WOULD BE
HELPFUL IF YOU STATE YOUR NAME
AND ROLE BEFORE THE VOTING
SESSION BEGINS.
I'D LIKE TO TURN IT OVER TO THE
DECISION LENS COLLEAGUES TO MOVE
FORWARD WITH THIS PART OF THE
AGENDA.
>> THANK YOU, DR. MOEN.
WE'LL GIVE A BRIEF PRESENTATION
OF THE MODULE AND PAT QUIN WILL
BE DOING OUR OVERVIEW FOR TODAY.
PAT, WHENEVER YOU'RE READY.
>> THANK YOU, JEN.
FIRST OFF I WANTED TO SAY THANK
YOU FOR HAVING US SUPPORT THE
ADVISORY COUNCIL.
AS ALWAYS IT'S A PLEASURE TO
WORK WITH YOU ALL AND IF YOU
NEED TECHNICAL SUPPORT
THROUGHOUT THE DAY AS DR. MOEN
MENTIONED YOU CAN REACH OUT TO
MYSELF, LAURA WILL BE WITH ME
THE NEXT FEW HOURS.
WE'LL BOTH BE MONITORING THE
CHAT AND WE'LL HAVE THE SUPPORT
TEAM.
THEY'RE NOT IN THIS MEETING BUT
THEY'RE AVAILABLE TO LEND A HAND
IF WE DO NEED ANYTHING AS WELL.
WE'LL DROP THEIR E-MAIL IN THE
CHAT.
I'LL SHARE MY SCREEN AND WALK
THROUGH A BRIEF DEMO OF THE
CAPABLEABILITY -- CAPABILITIES.
I'VE SEEN NAMES BEFORE BUT IF
YOU HAVE QUESTIONS, REACH OUT.
THERE'S NO NEW CAPABILITIES FROM
THE LAST SESSION.
HOPEFULLY THIS IS PRETTY
FAMILIAR FOR EVERYBODY.
THIS IS A PAGE YOU LOG IN AND
YOU'LL HAVE A PAGE THAT LOOKS
SIMILAR.
HAVE YOU THE TOP BANNER AND WILL
SEE NHLBI THE INSTANCE YOU'RE IN
AND SUPPORT ICON AS WELL AND TWO
MAIN TABS.
WE HAVE OUR MY TASKS AND
PORTFOLIO.
IT WILL SHOW ANY PORTFOLIOS
YOU'RE ASSIGNED TO.
IN HERE WE HAVE ANY RATING
ASSIGNMENTS YOU'VE BEEN GIVEN
WHICH EVERYBODY IN HERE TODAY
ALL OF OUR ADVISORY COUNCIL
MEMBERS HAVE BEEN ASSIGNED A
VOTING TASK FOR TODAY.
AS I REMINDER WHEN YOU LOG IN
USE GOOGLE CHROME OR MOZILAFOX.
USE ONE OF THOSE TWO BROWSERS
WHEN YOU LOG IN TODAY.
AS FAR AS LOGINS ARE CONCERNED,
EVERYBODY IN HERE ALREADY HAS AN
ACCOUNT.
YOUR ACCOUNTS HAVE BEEN UNLOCKED
AS WELL.
IF YOU NEED TO DO A PASSWORD
RESET YOU CAN CLICK ON THE I
FORGOT MY PASSWORD BUTTON IN THE
LOGIN PAGE AND IT WILL SEND AN
E-MAIL WITH A RESET LINK AND
THEN ALSO AS A REMINDER, YOUR
USER NAME IS GOING TO BE THE
E-MAIL ADDRESS INCLUDED IN THE
NHLBI ADVISORY COUNCIL ROSTER
SENT OUT IN ADVANCE OF THIS
MEETING.
IF YOU DON'T REMEMBER WHAT YOUR
E-MAIL ADDRESS WAS, SOMETIMES
PEOPLE CHANGE E-MAIL ADDRESSES,
JUST GO AHEAD AND ACCESS THE
LIST AND IT SHOULD BE THE E-MAIL
ASSOCIATED WITH YOUR LOG IN.
TO BEGIN OUR RATING ASSIGNMENT,
WE'LL NAVIGATE HERE TO MY TASKS.
WE'RE GOING FIND THE BUTTON THAT
SAYS RATE ALTERNATIVE FOR THE
PORTFOLIO LABELLED IB JUNE 2022
COUNCIL AND CLICK ANYWHERE IN
HERE.
WHEN WE LOG IN YOU CAN SEE I'VE
STARTED BECAUSE I DEMOED A BIT
OF THE PORTFOLIO ALREADY WITH
THE BEE LAST TIME BUT WHEN YOU
COME IN YOU'LL SEE AN ORANGE
BUTTON THAT SAYS START RATING
ALTERNATIVE.
IF YOU HAPPEN TO BE LOGGED OUT
OR SOMETHING LIKE THAT LIKE YOUR
WEB BROWSER CRASHES OR HAVE
INTERNET PROBLEMS DURING THE
DAY, ALL YOUR PROGRESS IS
AUTOMATICALLY SAVED SO WHEN YOU
COME BACK IT WILL SHOW THE
PROGRESS YOU'VE ALREADY MADE AND
THEN TWO, IT WILL SAY CONTINUE
RATING ALTERNATIVES AS WELL.
IN HERE WE HAVE OUR LIST OF
ALTERNATIVES AND CRITERIA.
ALTERNATIVES AND DECISION LENS
THE CONCEPTS.
THIS IS THE ACTUAL PIECE YOU'LL
BE EVALUATING AND IN CRITERIA WE
HAVE THE SIX CRITERIA WE'RE
EVALUATING THE PROJECTS AGAINST.
SO JUST A REFRESHER THOSE ARE
WHAT YOU GOT IN HERE.
YOU CAN SEE LEGACY COMMENTS IN
HERE AS WELL.
IN ORDER TO GET STARTED, WE'LL
CLICK THE ORANGE BUTTON THAT
SAYS CONTINUE ALTERNATIVES IN
YOUR CASE IT WILL SAY START
RATING ALTERNATIVES AND BRING US
TO THE LANDING PAGE.
YOU'LL GET SOME YELLOW
NOTIFICATIONS THROUGHOUT IT'S
JUST A SELF-GUIDED TOUR YOU'RE
WELCOME TO CLICK THROUGH OR
CLOSING IT BUT IT HAS USEFUL
POINTERS.
WHEN YOU LOG IN YOU'LL SEE THIS
CALLED SINGLE VIEW.
THIS IS ONE PROJECT, ONE
ALTERNATIVE AND ONE CRITERIA.
YOU CAN SEE IN HERE WE HAVE 2784
AND IMPORTANT OF THE SCIENTIFIC
MEDICAL HEALTH OR RESEARCH
RELATED QUESTION OR OPPORTUNITY.
WE HAVE THE DEEPER DEFINITION OF
THAT CRITERIA AS WELL THEN THE
RATING SCHEDULE WE'RE EVALUATING
IT AGAINST.
CLICK ON HOW YOU BEST ASSESS HOW
THAT CONCEPT PERFORMS AGAINST
THE CRITERIA JUST CLICK THAT AND
IT WILL HIGHLIGHT IN GREEN.
YOU'LL SEE THE CHECK MARK AND AT
THE BOTTOM YOU'LL SEE THE NEXT
BUTTON HIGHLIGHTS ORANGE AND YOU
CAN GO AHEAD AND ADVANCE.
I'VE DEMOED THIS SO I'LL AHEAD A
LITTLE BIT.
IF YOU DO NEED TO GO BACKWARDS
AND CHANGE SOMETHING, YOU CAN DO
THAT.
ALL YOU HAVE TO DO IS CLICK
PREVIOUS AND CHANGE YOUR
ASSESSMENT AND IT WILL BE
AUTOMATICALLY SAVED AND YOU'LL
BE GOOD TO GO.
A FEW OTHER FEATURES IN HERE IF
YOU WANT TO SEE MORE INFORMATION
ON THE CONCEPT YOU CAN CLICK THE
BLUE TEXT RIGHT HERE AND YOU CAN
SEE THE DESCRIPTION AND IN
OTHERS THERE COULD BE MORE AS
WELL AS AND YOU CAN CLICK IT BY
BACKING OR VIEW ALTERNATIVE
DETAILS AS WELL.
THE PURPLE TEXT IS ALSO
CLICKABLE.
THIS IS THE CRITERIA YOU'RE
EVALUATING IT AGAINST.
IF YOU CLICK THIS IT WILL GIVE
YOU A MORE DETAILED DESCRIPTION
OF THE CRITERIA.
YOU CAN SEE HERE WE HAVE A
LENGTHY DESCRIPTION OF WHAT WE
MEAN BY THIS.
IT WILL GIVE MORE DESCRIPTION OF
THE SCALE.
WE TRY TO PROVIDE AS MUCH
CLARITY AS POSSIBLE ABOUT WHAT
IS MEANT BY THIS CRITERIA AND
THEN HOW SHOULD YOU ACTUALLY
EVALUATE IT AGAINST THIS.
THAT'S WHY WE HAVE A DETAILED
DESCRIPTION AND DESCRIPTION OF
THE RATING SCALE AS WELL.
IN ORDER CHLO CLOSE THAT OUT YOU
CAN CLICK THE PURPLE TEXT OR THE
THREE BARS WHERE YOU SEE THE
CRITERIA AND DETAILS.
AGAIN, IN ORDER TO MAKE THAT
SELECTION, CLICK NEXT, CLICK THE
BEST FIT, CLICK NEXT AND MOVE
ON.
YOU CAN ALSO LEAVE A COMMENT AND
CLICK ON THE BUBBLE THAT SAYS
VIEW COMMENTS.
IF YOU CLICK ON THAT IN HERE YOU
CAN VIEW OTHER COMMENTS FROM
OTHER COUNCIL MEMBERS OR ALSO
ADD YOUR OWN COMMENT AS WELL.
IF THERE'S OTHER COMMENTS IN
HERE YOU'LL HE SEE -- YOU'LL SEE
NOTIFICATIONS THERE'S COMMENTS
AND YOU CAN ADD ONE TOO AND YOU
CAN SELECT THE CATEGORY.
MAYBE THE IN INTENSITY AS WELL.
IN THE PAST WE'VE MADE GOOD USE
OF THE COMMENTS FEATURE.
IF YOU DO WANT TO CAPTURE MAYBE
SOME NUANCE THAT ISN'T ENTIRELY
REFLECTED IN THE RATING SCALE,
THIS IS A GREAT PLACE TO GO
AHEAD AND RECORD THAT
INFORMATION AS WELL.
AS YOU'LL SEE UP HERE TOO IN THE
UPPER RIGHT HAND CORNER WE HAVE
THE PROGRESS BAR.
IT WILL SHOW EVERY CLICK YOU
HAVE TO MAKE.
WE'RE DOING 21 CONCEPTS AGAINST
SIX CRITERIA.
SO THAT'S GOING TO SHOW EACH
INDIVIDUAL CLIP YOU HAVE TO MAKE
SO YOU CAN SEE 10 RIGHT THERE.
I MAKE THE SELECTION AND I MOVE
ON AND NOW I'LL HAVE GONE UP TO
11.
THAT'S EVERY SINGLE INDIVIDUAL
CLICK YOU HAVE TO MAKE IN HERE.
I'M CONTINUE MOVING ON TO SHOW
MORE PROGRESS AS YOU CAN SEE
HERE IN THE BOTTOM RIGHT HAND
CORNER.
THIS IS A SPACE WHERE THERE'S
ALREADY COMMENTS FROM A PREVIOUS
RATER.
SO WE HAVE THAT AS WELL.
WE CAN GO AHEAD AND MAKE
SELECTIONS AND MOVE ON.
AND THE LAST THING I'LL SHOW IN
HERE AS WELL IS THERE'S ACTUALLY
ANOTHER WAY TO LOOK AT THIS
MENU.
RIGHT NOW WE'RE LOOKING AT
SINGLE VIEW WHICH IS ONE CONCEPT
AND ONE CRITERIA.
IF YOU WANT YOU CAN ALSO LOOK AT
IT IN WHAT IS CALLED MULTI-VIEW
AND THE WAY TO DO THAT IS GOING
TO BE TO NAVIGATE UP HERE TO THE
UPPER RIGHT HAND CORNER WHERE IT
HAS THREE DOTS AND IT WILL SAY
RATE IN MULTI-VIEW AND YOU CAN
SEE THE ONE CONCEPT AND THE
CRITERIA YOU'RE EVALUATING
AGAINST RIGHT HERE.
THIS IS EASIER FOR SOME PEOPLE
BECAUSE WE GO CONCEPT BY CONCEPT
AND REQUIRES YOU TO HIT THE NEXT
BUTTON LESS THAN THE OTHER
SINGLE VIEW METHODS.
IF WANT TO GO BACK TO THAT JUST
NAVIGATE UP HERE TO THE THREE
DOTS AND SAY RATE THE
ALTERNATIVE IN SINGLE VIEW AND
IT WILL REVERT BACK TO THE
ORIGINAL FORMAT.
ONCE YOU ARE 100% COMPLETE ON
YOUR RATINGS, YOU'LL KNOW THIS
BECAUSE ONE, YOU'VE GOT THE
PROGRESS BAR WILL SHOW YOU ALONG
THE WAY AND IT WILL CATCH
ANYTHING YOU MISS AND PUT IT
BACK IN FRONT OF YOU AT THE END.
YOU CAN WATCH THE PROGRESS BAR
AND AT THE END WHEN YOU'RE 100%
COMPLETE YOU'LL GET A POP-UP IN
THE MIDDLE OF THE SCREEN WITH A
GREEN CHECK MARK THAT BASICALLY
SAYS, THANK YOU, YOU'VE
COMPLETED EVERYTHING.
ONCE YOU HIT THAT YOU CAN EITHER
VIEW YOUR OWN INDIVIDUAL RESULTS
OR JUST LOG OUT, CLOSE OUT OF
YOUR BROWSER.
EVERYTHING YOU'VE DONE IS
AUTOMATICALLY SAVED.
AT THAT POINT, YOU CAN JUST
CLOSE OUT AND EVERYTHING IS
GOOD.
IF YOU DO WANT TO VIEW YOUR OWN
RESULTS IT WILL LOOK LIKE THIS
AND THIS IS JUST GOING TO SHOW
YOU HOW YOU INDIVIDUALLY RATED
THE CONCEPTS AGAINST EACH
CRITERIA.
I'LL REMIND THAT THE ACTUAL
OUTPUTS OF THIS ARE GOING TO BE
THE AGGREGATE OF EVERYBODY.
SO THIS ISN'T GOING TO BE THE
EXACT RESULTS BUT SHOW YOU HOW
YOU RATE THE CONCEPTS
INDIVIDUALLY.
IF YOU HAPPEN TO COME TO THIS
TEAM YOU CAN GO BACK BY SAYING
CONTINUE RATING AND GO BACK.
AT THIS TIME BARRING ANYTHING
ELSE FROM JEN, I THINK WE
COVERED EVERYTHING.
JEN, WAS THERE ANYTHING ELSE YOU
WANTED ME TO TOUCH ON?
>> THAT'S EVERYTHING, PAT.
NICELY DONE AND THANK YOU VERY
MUCH.
I'LL GIVE A REMINDER TO
EVERYBODY TO MOVE SLOWLY AND
CLICK ON THE CRITERIA FOR ALL
CONCEPTS OTHERWISE WE MAY
CONTINUE ON TO OUR VOTING.
>> THANK YOU, JEN.
I WANT TO REMIND EVERYBODY YOUR
COMMENTS MEAN A GREAT DEAL TO US
AS WELL AS THE NUMBERS YOU
ASSIGN WHEN VOTING ON THE
CONCEPTS.
FEEL FREE TO DISCUSS AND COMMENT
DURING THE DISCUSSION OR TO PUT
YOUR COMMENTS IN THAT PART OF
THE DECISION LENS.
WE'RE GOING BEGIN WITH THE
TRANS-NIH OR TRANS-NHLBI STATUS.
I GUESS THAT'S GOING TO BE
ACTUALLY THE LEAD DIVISION FROM
DCDS.
DAVID.
>> THANK YOU, LAURA.
GREETINGS FROM THE DIVISION OF
CARDIOVASCULAR SCIENCES.
BEFORE I GET INTO OUR CONCEPTS,
I WANT TO UNDER SCORE THE
IMPORTANCE OF THE COMMENTS YOU
PROVIDE ESPECIALLY THOSE THAT
YOU PROVIDE THROUGH DECISION
LENS.
WE USE THOSE COMMENTS NOT ONLY
IN THINKING ABOUT WHICH
INITIATIVES TO MOVE FORWARD BUT
ALSO IN TERMS OF EXECUTION.
IF AN INITIATIVE GOES FORWARD,
YOUR COMMENTS MAY HELP US SHAPE
IT, MAY HELP US SHAPE HOW WE
EXECUTE IT.
THANK YOU VERY MUCH IN ADVANCE.
OUR DIVISION HAS SIX CONCEPTS TO
BRING TO YOU TODAY FOR
DISCUSSION AND EVALUATION.
BUT THEY SUPPORT THREE EFFORTS
SO I'LL BE PRESENTING THEM IN
CLUSTERS TOGETHER AND YOU CAN
RATE ASSOCIATED CONCEPTS
TOGETHER WITHIN EACH EFFORT.
THE FIRST EFFORT IS A RENEWAL OF
OUR PEDIATRIC PART NETWORK WHICH
INVOLVED TWO CONCEPTS.
NUMBER 2773 AND 2784 WHICH WILL
SUPPORT THE COORDINATING CENTER
THROUGH A U24 MECHANISM AND UP
TO NINE CLINICAL CENTERS THROUGH
A UA1 MECHANISM.
NOW, CONGENITAL HEART DISEASE OR
CHD CONSISTS OF A NUMBER OF RARE
MALFORMATIONS THAT TOGETHER
REPRESENT THE MOST COMMON BIRTH
DEFECT AND THE ONE MOST LETHAL
IN INFANCY RESULTING IN HIGH
SOCIETAL ECONOMIC IMPACT.
THE NUMBER OF MALFORMATIONS
MAKES IT NECESSARY TO STUDY CHD
USING A MULTI-CENTER PLATFORM.
WE HAVE KEY QUESTIONS IN
PEDIATRIC CARDIOVASCULAR
DISEASE.
ONE OF THE PHN LANDMARK'S TRIALS
COMPARED TWO STRATEGIES FOR
NEONATAL REPAIR OF COMPLEX CHD
AND THAT STILL INFLUENCES
PRACTICE.
DURING THE TRIAL, SIGNIFICANT
PRACTICE VARIATION AND
RESPIRATORY SUPPORT WAS NOTED
ACROSS SITES.
THE PHN TURNED THIS INTO A
COLLABORATIVE LEARNING STUDY
WHICH FOLLOWED A MODEL FOLLOWING
SURGERY AND IT LEADS TO SHORTER
STAY AND OPIOID USING AND FOUND
IN THE CARDIAC CONGENITAL
HEADLINES AND IN THE FIRST YEARS
PHN CONDUCTED 13 TRIALS AND
OTHER OBSERVATIONAL STUDIES WITH
OTHERS PLANNED SOON AND 13,000
CHILDREN AND YOUNG ADULTS HAVE
BEEN ENROLLED.
STUDY DATA ARE REGULARLY
PRESENTED AND INFLUENCE
GUIDELINES.
THE PHN IS HIGHLY COLLABORATIVE
AND PARTNERED WITH OTHER
INSTITUTES AND PHARMACEUTICAL
STUDIED AND THE ORPHAN PRODUCTS
DIVISION AND ADVOCACY GROUPS AND
CONDUCTED TRIALS PROPOSED BY
NON-NETWORK INVESTIGATORS.
THE PHN DEMONSTRATED THE
NIMBLENESS AND VALUE DURING THE
PANDEMIC.
IT WAS ABLE TO PIVOT QUICKLY TO
CONDUCT THE LARGEST STUDY OF
MULTI-INFLAMMATORY SYNDROME IN
CHILDREN RECRUITING OVER 1200
CHILDREN IN ADOLESCENTS IN A
LITTLE OVER A YEARS.
THE PHN IS SHARING THE DATA WITH
AND PARTICIPATING IN THE RECOVER
INITIATIVE STUDYING PASC AND
THEY CONDUCTED THE FDA MANDATED
FOLLOW-UP STUDY ON POST-VACCINE
MYOCARD
MYOCARDITIS.
THEY TRAINED THE NEXT GENERATION
OF NURSING INVESTIGATORS AT THE
SCHOLARS PROGRAM HAS TRAINED 25
SCHOLARS AND FOUR COHORTS.
AND AN EVALUATION SHOWED THE
RETURN INVESTMENT WAS $10 IN
EXTRAMURAL FUNDING FOR EVERY
DOLLAR SPENT SUPPORTING THE PHN
SCHOLARS AND THEY WERE FIRST OR
SENIOR AUTHORS ON 109
MANUSCRIPTS WITHIN FIVE YEARS OF
THEIR SCHOLAR EXPERIENCE.
FOR THE RENEWAL WHICH HAS A NICE
GRAPHIC IN THE MATERIAL PROVIDED
FOR YOU OUR PLANS BUILD ON
SCIENCE ACROSS THE LIFE SPAN AND
PARTNERSHIPS AND TRAINING WHILE
EVOLVING THE PHN THROUGH FOCUS
ON THREE PILLARS, PRECISION
MEDICINE, DIVERSITY, EQUITY AND
INCLUSION AND BUILD ON EXISTING
COLLABORATIONS WITH THE
CONSORTIUM TO IMPROVE CLINICAL
CARE THROUGH TRIALS INFORMED BY
GENOMICS.
FOR DEI, THE FOCUS WILL BE ON
ADDRESSING THE STUBBORN
DISPARITIES IN INFANT
MORTALITIES DUE TO CHD
ASSOCIATED WITH RACE AND OTHER
DISPARITIES AND OUTCOMES.
THIS WILL BE DONE THROUGH STRONG
COMMUNITY ENGAGEMENT AT SITES
FOSTERING RESEARCH FOCUS ON
DIVERSITY AND SOCIAL
DETERMINATES AND EQUITABLE
IMPLEMENTATION OF THE FINDING.
FOR DATA SCIENCE THE PLAN IS TO
LEVERAGE THE INSTITUTE'S
CATALYST PROGRAM, SUPPORT
PROGRAM FOR PHYSIOLOGICAL AND
OTHER DATA WITH PATIENT-REPORTED
OUTCOMES AND ELECTRONIC HEALTH
RECORD DATA AND THIS WILL
SUPPORT A LARGE BODY OF SUPPORT
AND STREAMLINE CONDUCT AND
FACILITATE A NETWORK OF NETWORKS
AMONG THE PHN AND EXISTING CHD
REGISTRIES AND OTHER EFFORTS.
THESE CONCEPTS, THESE TWO
RELATED CONCEPTS ARE NOW OPEN
FOR DISCUSSION.
I'D BE HAPPY TO TAKE ANY
QUESTIONS YOU MAY HAVE.
IF YOU HAVE QUESTIONS, PLEASE
RAISE YOUR HAND OR PUT SOMETHING
IN THE CHAT.
I'M NOT SEEING HANDS RAISED OR
QUESTIONS IN THE CHAT SO PERHAPS
WE CAN MOVE TOWARDS RATING THESE
TWO RELATED CONCEPTS.
AND JEN, PLEASE LET ME KNOW WHEN
WE'RE ABOUT DONE.
>> SURE, WE'RE OFF TO A GOOD
START.
A REMINDER TO THOSE VOTING THERE
ARE TWO CONCEPTS TO VOTE FOR SO
MAKE SURE YOU ENTER THE VOTES
FOR EACH ONE OF THOSE.
AT THE MOMENT MAYBE A GOOD
TWO-THIRDS OF THE VOTES ARE IN
AS WELL AS I'LL GIVE EVERYONE A
MOMENT OR TWO TO DELIBERATE ON
THAT.
>> YES.
THERE WAS A QUESTION FROM
DR. CARNETHON, DO WE RATE BOTH
OF THESE?
YES.
WE RATE -- WE'RE ASKING TO RATE
BOTH CONCEPTS RELATED TO THE
PEDIATRIC HEART NETWORK.
THE REASON THEY'RE BEING
PRESENTED AS TWO DIFFERENT
CONCEPTS IS SOMETIMES THE VIEW
OF ONE PART OF A LARGE COMPLEX
INITIATE MAY BE DIFFERENT THAN
THE VIEW OF ANOTHER.
THERE WILL BE TWO DIFFERENT FOAs
THAT COME OUT.
ONE FOR THE COORDINATING CENTER
AND ONE NOR THE CLINICAL
SCIENCE.
>> SINCE THERE ARE TWO CONCEPTS
I'LL GIVE EVERYONE ANOTHER
MOMENT TO COMPLETE THEIR VOTES.
>> THE RENEWAL OF THE INITIATIVE
THAT'S AN R01 AND N01 AND IAA
INITIATIVE AND IT WILL BE AN
INTERAGENCY AGREEMENT.
THE SUDDEN DEATH AND BEYOND OR
SDY CASE REGISTRY WAS
ESTABLISHED IN 2013 IN
COLLABORATION WITH NINDS AND THE
CDC.
THE PROGRAM BENEFITS FROM THE
STRENGTHS OF EACH AGENCY.
THE CDC'S EXPERTISE IN PUBLIC
HEALTH SURVEILLANCE AND NIH's
EXPERT EASE AND RESEARCH AND THE
GOAL IS TO DESCRIBE SUDDEN DEATH
AND BEYOND USING
POPULATION-BASED SURVEILLANCE
AND SUPPORT RESEARCH INTO THE
CAUSES OF SUDDEN DEATH AND
BEYOND BY COMPILING PHENOTYPIC
DATA AND IT'S THE LARGEST
PROGRAM FOR SUDDEN DEATH AND
BEYOND IN THE U.S. AND 13 FUNDED
STATES AND JURISDICTIONS INCLUDE
ABOUT 30% OF ALL THE
U.S. PEDIATRIC POPULATION.
DATA CAN USED TO CALCULATE THE
SUDDEN UNEXPECTED INFANT DEATHS
AND ASTHMA AND SICKLE CELL
DISEASE.
OUR DATA INDICATE PEOPLE
EXPERIENCING POVERTY AND CERTAIN
GROUPS ARE DISPROPORTIONATELY
AFFECTED AND RATES OF SDY ARE
HIGHER AMONG FEMALES AND MALES.
ON THE SURVEILLANCE SIDE WE'LL
FOCUS ON HEALTH DISPARITIES AND
TO UNDERSTAND THE HOW AND WHY
AND TO OPTIMIZE THE VALUE OF THE
RESEARCH RESOURCE WE PROPOSE TO
COLLECT CARDIAC, LUNG AND AIRWAY
AND BRAIN TISSUE IN ADDITION TO
DNA.
TO PERFORM GENOMICS FOR
EFFICIENCY AND TO EMPLOY
ENGAGEMENT STRATEGIES TO
INCREASE PARTICIPATION BY UNDER
REPRESENTED POPULATIONS IN THE
RESEARCH COMPONENT AND ENHANCE
THE DIVERSITY OF DATA IN THE
REGISTRY.
THE RENEWAL ALSO INCLUDES A NOSI
OF SPECIAL INTEREST TO ENCOURAGE
INVESTIGATORS TO LEVERAGE THE
DATA AND BIO SPECIMENS TO
EXPLORE THE CAUSES OF SUDDEN
DEATH AND BEYOND.
WE'RE PROPOSING $12.5 MILLION
OVER FIVE YEARS THAT'S BEEN
INCREASED IN THE RENEWAL TO
RECOVER THE RELATED TISSUE
COLLECTION RELATED TO HEART,
LUNG, BRAIN.
WITH THAT I THANK YOU AND THIS
CONCEPT IS OPEN FOR DISCUSSION
OR QUESTIONS.
AGAIN, PLEASE RAISE YOUR HAND OR
PUT SOMETHING IN THE CHAT OR
TURN YOUR VIDEO ON.
WHATEVER IS MOST CONVENIENT.
I'M NOT SEEING ANYTHING IN THE
CHAT OR HANDS RAISED OR VIDEOS
TURNED ON SO I THINK WE MAY BE
ABLE TO MOVE ON TO RATING THIS
CONCEPT.
>> WE'RE NEARLY READY TO MOVE
ON.
WE'RE GIVING OUR REMAINING
COUNCIL MEMBERS A MOMENT VOTE.
>> WE'RE READY TO ADVANCE TO
CONCEPT 2770.
>> THANK YOU, JEN.
THE FINAL EFFORT WE'RE BRINGING
TO YOU TODAY FROM THE DIVISION
OF CARDIOVASCULAR SCIENCES IS
OUR PRIDE INITIATIVE.
IT IS SPORED BY THREE CONCEPTS
THAT WE'RE ASKING YOU TO
EVALUATE TODAY.
NUMBER 2770, 2771 AND 2772.
WE'LL BE ASKING FOR YOUR INPUT
ON A RENEWAL OF THE COORDINATION
CENTER FOR THE PRIDE PROGRAM AND
SUMMER INSTITUTE SITE FOR THE
NOSI OR ADMINISTRATIVE
SUPPLEMENTS FOR SMALL RESEARCH
PROGRAMS.
FOR SMALL WORK RESEARCH PILOT
AWARDS IN THE PRIDE PROGRAM.
SO THESE PROPOSALS SUPPORT
RENEWAL OF THE PROGRAMS TO
INCREASE DIVERSITY AMONG
INDIVIDUALS AND GAYS IN HEALTH
RELATED RESEARCH OR PRIDE FOR
RESEARCH FOCUSSED ON HEART,
LUNG, BLOOD AND SLEEP DISORDERS.
PRIDE IS COMPRISED OF SUMMER
INSTITUTES OF MENTORS, MENTEES A
COORDINATION CORE AND THE NHLBI
PROGRAM OFFICE.
THERE'S CURRENTLY NINE SUMMER
INSTITUTES AND EACH IS FOCUSSED
ON AN AREA OF SCIENCE RELEVANT
TO THE NHLBI MISSION FOR
SEQUENTIAL COHORTS OF 8 TO 12
MENTEES
THEY ATTEND AN INSTITUTE SESSION
FOR TWO CONSECUTIVE SUMMERS AND
A SHORT MID YEAR MEETING IN
BETWEEN AND ANNUAL PROGRAM-WIDE
MEETING INCLUSIVE OF ALL THE
SUMMER PROGRAMS.
THEY WORK TOGETHER TO ESTABLISH
MENTOR-MENTEE TEAMS MATCHED
BASED ON COMMON RESEARCH
INTERESTS.
AND THEY COLLABORATE TO
COMPLEMENT THE NEEDED EXPERT FOR
THE GOALS.
THE SPECIAL EMPHASIS ON
GRANTSMANSHIP AND DEVELOP
SPECIFIC RESEARCH PROJECTS AND
PROPOSALS AND ENHANCE THEIR
LONG-TERM FUNDABILITY.
MENTEES ARE SELECTED BY AN
APPLICATION PROCESS AS MANAGED
BY BOTH COORDINATION CENTER AND
THE SUMMER INSTITUTE PROGRAMS.
ELIGIBLE CANDIDATES MUST HAVE A
DOCTORAL DEGREE, FACULTY
POSITION, EARLY CAREER STATUS OR
NEW CAREER FOCUS AND PROTECTED
TIME ASSURED BY THAT OF
DEPARTMENT CHAIR OR DEAN.
IN THE CURRENT ITERATION OF
PRIDE ADDED THE SMALL RESEARCH
PROGRAM TO FUND PILOT PROGRAMS
LED BY PRIDE MENTEES TO
CONTRIBUTE TO PRELIMINARY DATA
TO DEVELOP A COMPETITIVE FUTURE
GRANT APPLICATION.
THE COORDINATION CENTER IS AN
IMPORTANT PART OF THE PROGRAM
AND SUPPORTS AND COMPLEMENTS THE
ACTIVITIES OF THE SUMMER
INSTITUTES AND THE PROGRAM STAFF
BY FACILITATING MENTEE
RECRUITMENT AND MATCHING WITH
THE SUMMER INSTITUTE SITES AND
MENTORS, CO-PLANNING AND
CO-FACILITATING PROGRAM-WIDE
MEETINGS AND ACTIVITIES WITH OUR
NHLBI PROGRAM STAFF,
FACILITATING REVIEW OF THE SMALL
RESEARCH PROGRAM PILOT AWARD
APPLICATIONS AND CONDUCTING
LONGITUDINAL DATA COLLECTION AND
PROGRAM-WIDE EVALUATION TO
BENCHMARK PROGRAM SUCCESS AND
OVER ALL PROGRAM IMPACT.
PRELIMINARY OUTCOMES SHOW
MEANTEES HAVE AN INCREASED
PUBLICATION AND GRANTS AND 50%
FROM EARLIER PRIDE COHORT HAVE
EARNED AT LEAST ONE PROMOTION IN
ACADEMIC RANK.
BASED ON THIS TRACK RECORD AND
WHAT WE LEARNED TO DATE, THE
RENEWAL AIMS TO SUSTAIN THAT
SUCCESS.
IN ADDITION TO THE CURRENTLY
SUPPORTED AREAS OF TRANLATIONAL
AND CLINICAL AND IMPLEMENTATION
SCIENCE AMONG HEART, LUNG, BLOOD
CONDITIONS AND THERE IS
DIVERSITY OF THE WORKFORCE
INCLUDING FOR EXAMPLE
CONTEMPORARY INTERVENTION
RESEARCH APPROACHES SUCH AS IVE
AND PRAGMATIC TRIALS, BEHAVIORAL
AND SOCIAL SCIENCE RESEARCH,
EMERGING TECHNOLOGY AND CLINICAL
INFORMATICS, GLOBAL HEALTH AND
PRECISION HEALTH.
SO THIS RENEWAL SUPPORTS THE
CONTINUATION OF THE COORDINATION
CORE AND SUMMER INSTITUTE AND
SMALL RESEARCH PROGRAM FOR A
FIVE-YEAR PERIOD.
THE CURRENT PROGRAM'S RECRUITING
THE LAST COHORT OF MENTEES TO
START THIS SUMMER AND FINISH
NEXT SUMMER WITH FUNDING ENDING
THE END OF NEXT YEAR.
SO THIS RENEWAL FOR FISCAL YEAR
'24 WELL ENABLE UNINTERRUPTED
PROGRAM AND THERE'S A SCIENTIFIC
WORKFORCE AND THE CONTINUATION
WILL STIMULATE THE ENTRY OF NEW
RESEARCH INVESTIGATORS FROM
HISTORICALLY EXCLUDED AND UNDER
REPRESENTED GROUPS INTO THE
PIPELINE ACROSS EXISTING AND
EMERGING AREAS OF SCIENCE
RELEVANT TO OUR MISSION.
WITH THAT, THESE CONCEPTS ARE
NOW OPEN FOR DISCUSSION OR
QUESTIONS.
>> WE'RE OFF TO A GOOD START
WITH THE VOTING.
REMEMBER THERE'S THREE
INDIVIDUAL CONCEPTS TO VOTE FOR.
>> I'M NOT SEEING QUESTIONS IN
THE CHAT OR HANDS RAISED OR
ANYONE COMING ON VIDEO SO I
THINK WE MAY BE PREPARED TO PASS
THE BATON WHEN THE VOTING IS
COMPLETED.
>> I'LL PAUSE HERE.
>> I SEE SOMEONE COMING ON
VIDEO.
RESPONSE HE'LL BE THE RECIPIENT
OF THE BATON.
>> I'LL TAKE A PAUSE TO VOTE ON
THE CONCEPTS AND I'LL LET YOU
KNOW WHEN WE CAN MOVE ON.
>> I'D LIKE TO THANK THE MEMBERS
FOR PROVIDING INPUT AND ANY
COMMENTS YOU MIGHT MAKE THROUGH
THE SYSTEM.
WE TAKE THEM SERIOUSLY IN MOVING
CONCEPTS FORWARD AND HOW WE
SHAPE AND EXECUTE THEM.
MANY THANKS.
WITH THAT I WILL GO BACK ON
MUTE.
>> WE'RE ALMOST READY TO
PROCEED.
I'M WAITING FOR ONE REMAINING
VOTE.
WE'RE NOW READY TO MOVE ON.
>> THANKS, JEN AND DAVID AND
THREW FOR THE BATON AND I'LL
GRAB THAT AND SEE IF WE CAN
CRUISE DOWN THE TRACK WITH IT.
THE LUNG DIVISION WILL PRESENT
THREE INITIATIVES THIS AFTERNOON
THAT WE ARE LEADING BUT AS
YOU'LL SEE TWO OF THEM ARE NIH
WIDE AND ONE IS NHLBI WIDE AND
THEY'RE TRANS-INITIATIVES
DEVELOPED BY A TEAM OF OUR STAFF
ACROSS THE INSTITUTE AND WOULD
AND HELP FROM OTHER I.C.s AS
WELL.
THIS IS ENTITLED LIMITED
COMPETITION.
THIS IS A SMALL GRANT PROGRAM
FOR KO1, K25 AND OTHERS AND
OPTIONAL.
YOU MAY THINK I TALKED TO YOU
ABOUT THIS ONE AND YOU'RE RIGHT,
WE PRESENTED A PROGRAM PLAN FOR
GRANTS THAT CAME INTO THIS
PARTICULAR INITIATIVE FOR THE
LAST ROUND.
THIS IS A RENEWAL OF THE
PROGRAM.
AND THERE'S KO1, K08, K23 AND
K25.
IT'S FOR SMALL GRANT SUPPORT TO
EXPAND THEIR K RESEARCH
OBJECTIVES OR TO BRANCH OUT TO A
NEW AREA OF RESEARCH RELATED TO
THEIR K AWARD STUDIES.
AND THERE'S ADDITIONAL SUPPORT
TO TRANSFER TO RESEARCH IN
DEPENDENCE AND RESEARCH EFFORT
OF THE P.I. IS REQUIRED.
THE PROGRAM WAS STARTED IN 2015
AS A PILOT AND THEN RENEWED
AGAIN IN 2018 AND 2020 AND SO
YOU THINK AND THE CURRENT
PROGRAM EXPIRED IN OCTOBER OF
'21.
WE AWARDED 115 NEW AWARDS
BETWEEN 2016 AND 2021.
SO THE PERIOD THAT THIS PROGRAM
EXISTED.
SO A PRETTY GOOD NUMBER OF
AWARDS.
WE HAVE LIMITED DATA BUT WE DO
HAVE SOME DATA TO SUGGEST THE
RO3 AWARDEE LIKELY TO ABSTAIN AN
R01 OR EQUIVALENT GRANT.
YOU'LL INTEREST HAVE TO TAKE MY
WORD FOR THAT BECAUSE I DON'T
HAVE TIME TO SHOW THE DATA.
MAYBE AT SOME POINT WE CAN BRING
IT TO YOU.
AT THIS POINT WE HAVE DONE GOOD
ANALYSIS OF WHAT WE HAVE AND
BELIEVE THE R03 PROGRAM IS
ACHIEVING THE STATED GOALS OF
ACHIEVING THE RESEARCH
INDEPENDENCE OR AID TO
TRANSITION TO THE NEXT AWARD.
WE WOULD LIKE TO MEET THE
PROGRAM AND IT'S MEETING ITS
GOALS FOR AN ADDITIONAL THREE
YEARS TO SUPPORT A TOTAL OF 90
NEW AWARDS WITH A DIRECT COST OF
75K PER YEAR.
SO WHAT ARE WE CHANGES FROM THE
PREVIOUS ONE TO NOW FROM WHAT WE
LEARN?
WE MADE A FEW MODIFICATIONS, NOT
MAJOR ONES BUT A COUPLE WE THINK
ARE GOING TO BE BENEFICIAL TO
THE APPLICANTS AND AWARDEES.
FIRST OF ALL WE'LL INCREASE THE
DIRECT COST FROM $50,000 TO
$75,000 AND HOPE TO AWARD 20 TO
30 PER FISCAL YEAR AND WE ADDED
THE K25 AS AN ELIGIBLE MECHANISM
FOR THIS RO3 PROGRAM.
SO WITH THAT BRIEF BACKGROUND
GIVING YOU A SENSE OF WHAT WE'RE
AFTER HERE WITH THE RENEWAL OF
THIS PROGRAM, I'LL STOP THERE.
I'LL BE HAPPY TO TAKE ON ANY
QUESTIONS THAT YOU MAY HAVE.
>> DOES THE AWARD THAT COME FROM
NHLBI OR THE RESEARCH PROPOSED
IN THE RO3 HAS TO BE RELEVANT TO
THE NHLBI?
>> IT'S A LIMITED COMPETITION
FOR NHLBI AWARDEES.
IF YOU HAVE A CANCER GRANT IT'S
NOT ELIGIBLE FOR THIS MECHANISM.
>> OKAY.
I THOUGHT I UNDERSTOOD THAT.
THANK YOU.
>> I'M NOT SEEING ANYTHING IN
THE CHAT BOX.
RAISE YOUR HAND OR SPEAK UP OR
ENTER ANYTHING IN THE CHAT.
IF NOT DO THE VOTING ON THIS
ONE.
>> THE VOTING HAS BEEN COMPLETED
AND WE'RE READY TO ADVANCE TO
THE NEXT CONCEPT.
AIDS PROGRAM.
IT'S NUMBER 2763, AND THIS ONE
IS SECONDARY PARTICIPATION IN
CATALYST AWARD FOR EARLY STAGE
INVESTIGATORS PURSUING RESEARCH
IN HIV COMORBIDITIES,
COINFECTIONS AND COMPLICATIONS.
AND THIS ONE IS GOING TO USE A
DP1 CLINICAL TRIAL OPTIONAL
MECHANISM.
SO OUR DESIRE IS TO SIGN ON AS A
SECONDARY INSTITUTE ON A
TRANS-NIH DP1 PROGRAM
ANNOUNCEMENT INITIATIVE THAT'S
LED BY THE NIDDK, DIABETES,
DIGESTIVE DISEASE AND KIDNEY
INSTITUTE.
THE GOAL HERE IS TO INCREASE
FUNDING OPPORTUNITIES TO PROMOTE
AND SUPPORT CREATIVE EARLY STAGE
INVESTIGATORS PROPOSING HIGH
IMPACT POTENTIALLY
TRANSFORMATIVE RESEARCH ON
HIV-ASSOCIATED COMORBIDITIES,
CO-INFECTIONS AND COMPLICATIONS.
SO THIS ANNOUNCEMENT, THIS
OPPORTUNITY WAS DEVELOPED
FOLLOWING A PORTFOLIO ANALYSIS
OF THE HIV GRANTS AT NHLBI WHICH
SHOW THE NUMBER OF GRANT
SUBMISSIONS AND AWARDS FOR THE
EARLY STAGE INVESTIGATORS IN
HIV/AIDS HAS BEEN VERY LOW OVER
THE PAST FEW YEARS, THREE TO
FOUR R01 GRANTS AWARDED ON
AVERAGE PER YEAR.
IN ADDITION, THE ESIs AND
HIV/AIDS ARE LESS SUCCESSFUL IN
GETTING R01 AWARDS THAN ESIs
AND OTHER FIELDS OF RESEARCH.
SO THIS TREND IS NOT UNIQUE TO
NHLBI, BUT SEEMS TO BE SIMILAR
ACROSS OTHER NIH INSTITUTES.
SO GIVEN THE SMALL NUMBER OF
JUNIOR INVESTIGATORS PURSUING
RESEARCH IN HIV/AIDS, THERE ARE
SOME CONCERNS THAT THE WORKFORCE
OF RESEARCHERS IN THIS AREA MAY
BE SLOWLY DECLINING.
AND SO TO ADDRESS THOSE
CONCERNS, THIS INITIATIVE WAS
DEVELOPED, AIMED AT INCREASING
THE FUNDING OPPORTUNITIES TO
SUPPORT OBVIOUSLY THE NEXT
GENERATION OF RESEARCHERS IN
HIV/AIDS BY ATTRACTING MORE
ESIs TO SUBMIT GRANT
APPLICATIONS AND INCREASE THE
NUMBER OF ESIs DOING WORK IN
AIDS AND HIV.
SO WE BELIEVE THAT THIS
MECHANISM, THIS DP1 MECHANISM IS
BETTER SUITED FOR THIS KIND OF
AN APPROACH COMPARED TO THE
STANDARD R01 MECHANISM TO
AUTOIMMUNE DRESS CURRENTLY --
ADDRESS THE CURRENT PIPELINE
DOING RESEARCH IN THIS AREA.
DP1 AWARDS ARE GENERALLY MADE TO
SUPPORT CREATIVE INVESTIGATORS
PROPOSING HIGHLY INNOVATIVE AND
PIONEERING STUDIES.
THEY'RE NOT RENEWABLE.
THEY'RE SINGLE PI STUDIES ONLY,
AND AS SUCH, THEY FOSTER THE
ESTABLISHMENT OF INDEPENDENT
RESEARCH PROGRAMS.
THEY'RE USED IN OUR COMMON FUND
QUITE FREQUENTLY, OUR PIONEER
AWARDS AND OTHERS USE THIS
MECHANISM.
SO IT'S NOT A NEW MECHANISM,
IT'S ONE THAT'S BEEN AROUND, BUT
WE HAVEN'T USED IT MUCH IN OUR
INITIATIVES, MOSTLY BECAUSE WE
CAN DO IT THROUGH OTHER MEANS,
BUT THIS ONE MAY BE A BETTER ONE
FOR WHERE WE ARE WITH THE AIDS
PROGRAM RIGHT NOW.
WE'D LIKE TO FUND UP TO FOUR ESI
APPLICATIONS AT NHLBI IN EACH OF
THREE RECEIPT DATES, SO A TOTAL
OF ABOUT 12 APPLICATIONS IN
TOTAL, AND THIS WOULD AGAIN BEEF
UP THE POOL OF NHLBI ESIs
PERFORMING HIV/AIDS RESEARCH
BASED ON WHAT WE'VE ALREADY SEEN
OVER THE PAST FEW YEARS.
THE BUDGETS WILL BE LIMITED TO
350K PER YEAR DIRECT COST WITH A
MAXIMUM OF FIVE YEARS.
SO THAT PRETTY MUCH SUMMARIZES
WHERE WE ARE WITH THIS PROGRAM,
AND I'LL STOP THERE AND TRY TO
ANSWER QUESTIONS IF YOU HAVE
THEM, AND CLOSE AT THIS POINT.
THIS IS ALSO ONE I SHOULD MAKE
SURE EVERYONE REALIZES WAS
DEVELOPED BY OUR AIDS TEAM.
YOU HEARD A LITTLE FROM SHIMEON
THIS MORNING, SO THIS IS ONE
THAT WAS DEVELOPED BY A VERY
ESTABLISHED TEAM OF OUR STAFF IN
THE NHLBI THAT REALLY HAVE
INTERFACED WITH THE OFFICE OF
AIDS RESEARCH TO MAKE SURE THAT
ALL OF THESE THINGS ALIGN WITH
ALL OF OUR STRATEGIC PRIORITIES.
>> IF THERE ARE NO QUESTIONS FOR
THIS CONCEPT, WE'RE READY TO
ADVANCE TO THE NEXT ONE.
I SEE ALL THE VOTES IN DECISION
LENS.
>> OKAY.
VERY GOOD.
OKAY.
SO THE LAST ONE THAT THE LUNG
DIVISION IS LEADING IS NUMBER
2692.
THIS ONE IS ENTITLED SECONDARY
PARTICIPATION IN THE RENEWAL OF
THE TRANS-NIH PROGRAM
SPECIALIZED CENTER OF RESEARCH
EXCELLENCE ON SEX DIFFERENCES.
THIS IS A SCORE PROGRAM.
IT'S A U54 MECHANISM WHERE
CLINICAL TRIALS ARE OPTIONAL.
NOW THIS PROGRAM IS LED BY THE
OFFICE OF RESEARCH ON WOMEN'S
HEALTH, AND AGAIN, I DON'T HAVE
TO REPEAT MYSELF BY SAYING THAT
WE HAVE A REALLY TERRIFIC GROUP
OF STAFF WHO ARE WORKING ACROSS
NHLBI AS WELL AS WITH THE OFFICE
OF WOMEN'S HEALTH AND OUR OTHER
ICs TO REALLY DEVELOP THESE
TRANS INITIATIVES THAT ARE
RELEVANT TO ALL OF OUR -- ALL OF
THE NIH INSTITUTES.
SO THE CURRENT SCORE PROGRAM,
THIS IS A RENEWAL, SO THE
CURRENT ONE LEVERAGES ABOUT 15
YEARS OF PRIOR INVESTMENT, AND
REMAINS THE ONLY NIH CENTERS
PROGRAM SUPPORTING TRANSLATIONAL
RESEARCH FOCUSED ON SEX
DIFFERENCES.
SO THIS RENEWAL SEEKS TO
CONTINUE THIS PROGRAM FOR AN
ADDITIONAL FIVE YEARS TO PROMOTE
RESEARCH IN MAJOR MEDICAL
CONDITIONS AFFECTING WOMEN IN
THE U.S.
SO VERY BROAD.
THIS IS A TRANS NHLBI INITIATIVE
UNDER THE UMBRELLA OF THE NHLBI
WOMEN'S HEALTH WORKING GROUP.
APPLICATIONS WILL BE ACCEPTED
FROM ALL THE DIVISIONS AND WILL
SOLICIT APPLICATIONS ACROSS ALL
OF OUR MISSION AREAS.
SO WE THINK THIS IS A VERY
RELEVANT PROGRAM TO NHLBI AND WE
THINK WE CAN BENEFIT FROM THIS
PROGRAM AND WE'LL DO A GOOD JOB
OF TRYING TO BROADCAST WIDELY
ITS AVAILABILITY.
IT'S VERY SIMILAR TO AN NHLBI
PROJECT PROGRAM WITH A FOCUS ON
SEX DIFFERENCES AND WOMEN'S
HEALTH, AND WILL OPERATE AS A
U54 COOPERATIVE AGREEMENT WITH
PROGRAM STAFF OVERSIGHT.
SO THAT'S WHAT DIFFERENTIATES IT
A BIT FROM THE STANDARD P01.
APPLICATIONS ARE RESPONSIVE S
PROGRAM SHOULD INCLUDE AT LEAST
THREE SYNERGISTIC PROJECTS, A
CAREER ENHANCEMENT CORE FOR THE
NEXT GENERATION OF SCIENTISTS IN
THE STUDY OF SEX DIFFERENCES,
AND FINALLY AN ADMINISTRATIVE
CORE TO OVERSEE THE PROJECTS'
CAREER CORE FUNCTIONS.
THE PROGRAM AS I MENTIONED
ALREADY IS LED BY ORWH, AND THEY
HAVE DETERMINED THAT THIS
PROGRAM WOULD BENEFIT FROM FIVE
YEARS OF SUPPORT.
THE APPLICATIONS CANNOT EXCEED
$1 MILLION PER YEAR IN DIRECT
COSTS.
ORWH WILL SET ASIDE FUNDS TO
FULLY SUPPORT UP TO THREE U55
SCORE PROGRAMS, BUT IC
CO-FUNDING WOULD ALLOW THEM TO
FUND ADDITIONAL CENTERS.
SO THAT'S WHERE WE AND OTHERS
WILL STEP IN.
WITH THIS SECONDARY
PARTICIPATION, WE'RE REQUESTING
TO CO-FUND ONE NHLBI CENTER AT
50% FOR A TOTAL PROGRAM COST OF
JUST UNDER $4 MILLION.
SO AGAIN, VERY FOCUSED ON OUR
MISSION AREA AND CO-FUNDED WITH
ORWH, WE THINK THAT THIS IS A
MODEST INVESTMENT TO ALLOW US TO
BENEFIT FROM THIS TRANS-NIH
INITIATIVE.
IT REFLECTS THE SAME SETASIDE AS
OUR LAST PARTICIPATION IN THIS
PROGRAM.
AS I SAID, IT'S A RENEWAL SO
THIS WOULD BE NO DIFFERENT THAN
WHAT WE BASICALLY SPENT IN OUR
LAST CYCLE, AND IT WOULD BE
SPENT ONLY IF WE RECEIVE
MERITORIOUS APPLICATIONS.
AGAIN, VERY FOCUSED ON THE
MISSION AREAS OF NHLBI.
SO WITH THAT, I'LL STOP, SEE IF
THERE ARE ANY QUESTIONS AND I'LL
TRY TO DO MY BEST WITH THIS UP .
SO I'LL LET YOU ALL HAVE AT IT.
LOOKING FOR HANDS, VOICES OR
COMMENTS IN CHAT.
>> NOT SEEING ANYTHING.
>> SINCE THERE ARE NO COMMENTS,
IT'S OKAY TO MOVE ON TO THE NEXT
CONCEPT.
>> THANK YOU ALL VERY MUCH.
SO I THINK WE'RE GOING TO TURN
THIS OVER TO DR. MENSA.
HE IS GOING TO TAKE US THROUGH
THE NEXT COLLECTION OF
INITIATIVES.
GEORGE?
>> THANKS, JIM.
THE CENTER FOR TRANSLATIONAL
RESEARCH AND IMPLEMENTATION
SCIENCE WILL PRESENT NINE
CONCEPTS.
I PROMISE YOU I WILL NOT PRESENT
AND HAVE YOU VOTE ONE BY ONE FOR
ALL NINE.
THEY REALLY REPRESENT THREE
CLUSTERS OF THREE DISTINCT
EFFORTS.
SO I WILL TELL YOU WHEN WE NEED
TO VOTE.
THE FIRST ONE IS CONCEPT NUMBER
2684.
AND IT'S A REISSUE OF FUNDING
OPPORTUNITY ANNOUNCEMENT,
DISSEMINATION AND IMPLEMENTATION
RESEARCH.
IT SERVES AS THE PRIMARY
MECHANISM FOR SUPPORTING
DISSEMINATION AND IMPLEMENTATION
OR D & I RESEARCH AT NIH.
IT IS VERY WELL-KNOWN BY NHLBI,
EXTRAMURAL RESEARCH
INVESTIGATORS, AND NHLBI
LEADERSHIP AND CONTINUED
PARTICIPATION IN THEIR FUNDING
OPPORTUNITY ANNOUNCEMENT IS
CRUCIAL, IN FACT, OUR INSTITUTE
RECEIVES THE THIRD LARGEST
NUMBER OF APPLICATIONS TO THIS
FOA.
THE GOAL OF THE FUNDING
OPPORTUNITY ANNOUNCEMENT IS TO
SUPPORT INNOVATIVE APPROACHES
FOR IDENTIFYING, UNDERSTANDING,
AND DEVELOPING STRATEGIES THAT
WILL STIMULATE THE SUSTAINED
ADOPTION AND IMPLEMENTATION OF
EVIDENCE-BASED INTERVENTIONS,
TOOLS, STRATEGIES AND GUIDELINES
FOR HEART, LUNG, BLOOD AND SLEEP
DISEASES AND DISORDERS,
INCLUDING ESPECIALLY IN
UNDERSERVED POPULATIONS.
ALTHOUGH NOT OFTEN EMPHASIZED,
IT ALSO SUPPORTS
DEIMPLEMENTATION OF THE
DEVELOPMENT OF STRATEGIES TO
STOP OR REDUCE THE USE OF
INTERVENTIONS THAT ARE
INEFFECTIVE, UNPROVEN, LOW VALUE
OR HARMFUL.
IN ADDITION, STUDIES TO ADVANCE
DISSEMINATION AND IMPLEMENTATION
RESEARCH METHODOLOGY, FRAME
WORKS AND METHODS OF
IMPLEMENTATION OUTCOMES ARE
ENCOURAGED.
AS YOU KNOW, D & I RESEARCH
PROVIDES RIGOROUS APPROACHES TO
BRIDGE THE GAP BETWEEN THE
EVIDENCE FROM RESEARCH FROM
PRACTICE AND FROM POLICY BY
BUILDING A KNOWLEDGE BASE ABOUT
HOW HEALTH INFORMATION,
EFFECTIVE INTERVENTIONS AND NEW
CLINICAL PRACTICE GUIDELINES AND
TOOLS ARE INTEGRATED INTO
ROUTINE CLINICAL AND PUBLIC
HEALTH SETTINGS.
AND FOR CONTINUOUS IMPROVEMENT
IN THE DELIVERY OF HIGH QUALITY
HEALTHCARE IN A BROAD RANGE OF
SETTINGS.
THIS FOA IS CURRENTLY THE MAIN
MECHANISM THAT IS SPECIFICALLY
DESIGNED FOR
INVESTIGATOR-INITIATED
DISSEMINATION AND IMPLEMENTATION
RESEARCH.
ALMOST ALL APPLICATIONS RECEIVED
THROUGH THIS FOA ARE REVIEWED BY
A STUDY SECTION THAT IS
DEDICATED TO DISSEMINATION AND
IMPLEMENTATION RESEARCH WITH THE
REQUISITE EXPERTISE.
WE ARE CURRENTLY IN THE MIDDLE
OF A FORMAL PORTFOLIO ANALYSIS
WITH THE SUPPORT OF THE NHLBI
OFFICE OF PLANNING, ANALYTICS
AND EVALUATION, AND WE HOPE TO
SHARE THE PROGRAM PRODUCTIVITY
AND OTHER KEY FINDINGS WITH
COUNCIL IN THE NEAR FUTURE.
BUT TO GIVE YOU A FLAVOR OF SOME
OF THE FUNDABLE APPLICATIONS
RECEIVED IN THIS COUNCIL, THERE
IS AN APPLICATION ON INTEGRATED
RESPONSE PROGRAM TO ASTHMA IN
PUERTO RICO, THERE IS AN
APPLICATION ON HOW TO OPTIMIZE
THE IMPLEMENTATION OF MULTILEVEL
INTERVENTIONS IN CLINICS FOR
PEDIATRIC HYPERTENSION IN
COMMUNITY HEALTH CENTERS IN
CHICAGO, AND ONE FROM ABROAD,
HOW WE ACCELERATE THE DELIVERY
OF RHEUMATIC HEART DISEASE
PREVENTION INTERVENTIONS IN
UGANDA.
I'LL PAUSE HERE TO SEE IF YOU
HAVE ANY QUESTIONS, COMMENTS OR
SUGGESTIONS FOR US.
AND AGAIN, I WILL REITERATE WHAT
DR. MOEN HAS SAID, YOUR COMMENTS
REALLY ARE VERY, VERY VALUABLE
TO US.
ESPECIALLY AS WE GO INTO
EXECUTION OF THESE PROGRAMS.
JEN, I DON'T SEE ANYTHING IN THE
CHAT.
SO I'LL WAIT TO HEAR FROM YOU.
>> I'LL PAUSE FOR A MOMENT.
THERE'S ONE OR TWO
COUNCILMEMBERS WHO ARE STILL
ADDING THEIR VOTES.
THEY HAVE NOW COMPLETED THEM AND
WE CAN MOVE ON TO THE NEXT
CONCEPT.
>> GREAT.
THE NEXT CONCEPT IS ACTUALLY A
CLUSTER, AND BEFORE I BEGIN, I
SHOULD REALLY RECOGNIZE THE
OUTSTANDING WORK DONE BY BECKY
WILLIAMS, WHO IS NOW NHLBI
GLOBAL HEALTH RESEARCH PROGRAM
DIRECTOR, AND SEVERAL KEY STAFF
MEMBERS FROM ACROSS OUR NHLBI
DIVISIONS, INCLUDING OUR
DIVISION OF EXTRAMURAL RESEARCH
ACTIVITIES, AND ALSO A BIG THANK
YOU TO THE LEADERSHIP AND STAFF
OF THE FOGARTY INTERNATIONAL
CENTER, WHO HAVE HELPED MAKE
GLOBAL HEALTH PROGRAMS
SUCCESSFUL.
I'LL NOW PRESENT THREE RELATED
CONCEPTS FOR COUNCIL'S
CONSIDERATION OF NHLBI SECONDARY
PARTICIPATION IN THE NIH-WIDE
GLOBAL HEALTH RESEARCH CAPACITY
BUILDING.
THIS IS A FUNDING OPPORTUNITY
ANNOUNCEMENT ISSUED BY THE
FOGARTY CENTER.
EACH OF THE CONCEPTS REQUIRES A
SEPARATE VOTE, HOWEVER, THESE
THREE THAT I'M PRESENTING NOW
ARE RELATED TO TWO GLOBAL HEALTH
RESEARCH CAPACITY BUILDING
PROGRAMS THAT ARE CRUCIAL FOR
BUILDING A PIPELINE FROM
TRAINING TO INDEPENDENCE FOR
EARLY CAREER SCIENTISTS IN LOW
AND MIDDLE INCOME COUNTRIES.
I'LL FIRST DESCRIBE THE
INSTITUTIONAL D43 INITIATIVE,
THAT'S CONCEPT NUMBER 2677,
WHICH IS ALSO KNOWN AS THE NCD
LIFESPAN, THE CHRONIC
NON-COMMUNICABLE DISEASE AND
DISORDERS ACROSS THE LIFESPAN.
AND I'LL ASK YOU TO VOTE ON
THAT.
I WILL THEN DESCRIBE THE RELATED
INDIVIDUAL K43s WITHIN THE
EMERGING GLOBAL LEADER PROGRAM,
AND THERE ARE TWO OF THEM.
NUMBER 2879, AND 2878.
AND I'LL REMIND YOU WHICH ONES
THEY ARE.
SO FIRST THE NCD LIFESPAN.
THE PURPOSE OF THE
D43 INSTITUTIONAL NCD LIFESPAN
INITIATIVE IS TO SUPPORT
COLLABORATIVE RESEARCH TRAINING
BETWEEN INSTITUTIONS IN THE U.S.
AND THOSE IN LOW AND MIDDLE
INCOME COUNTRIES.
AND HELP SUSTAINABLY STRENGTHEN
THE CAPACITY OF LOW AND MIDDLE
INCOME COUNTRY INSTITUTION
INVESTIGATORS SO THAT THEY CAN
CONDUCT RESEARCH ON NCDs.
THIS INITIATIVE AIMS TO TRAIN
LOCAL IN-COUNTRY EXPERTS TO
CONDUCT RESEARCH ON CHRONIC
NON-COMMUNICABLE DISEASES AND
DISORDERS WITH THE ULTIMATE GOAL
OF IMPLEMENTING EVIDENCE-BASED
INTERVENTIONS RELEVANT TO THEIR
OWN COUNTRY SETTINGS.
AS YOU HEARD FROM DR. GIBBONS
EARLIER THIS MORNING, CHRONIC
NON-COMMUNICABLE DISEASES WITHIN
OUR MISSION AREA ARE STEADILY
INCREASING AROUND THE WORLD,
INCLUDING IN LOW AND MIDDLE
INCOME COUNTRIES, AND THEY
ACCOUNT FOR MORE THAN HALF OF
THE EXPENDITURES FOR HEALTHCARE
AND MORE THAN 60% OF THE
DISABILITY-ADJUSTED LIFE YEARS
IN THESE COUNTRIES.
THEY'VE ENDORSED A GLOBAL ACTION
PLAN FOR THE PREVENTION AND
CONTROL OF THESE DISEASES, AND
IT INCLUDES PROMOTION AND
SUPPORT OF NATIONAL CAPACITY FOR
HIGH QUALITY RESEARCH AND HEALTH
SYSTEMS DEVELOPMENT.
THIS INITIATIVE SUPPORTS
MERITORIOUS TRAINING PROGRAMS
THAT CAN SUSTAINABLY STRENGTHEN
HEART, LUNG AND BLOOD AND SLEEP
RESEARCH CAPACITY IN LOW AND
MIDDLE INCOME COUNTRIES AND IN
RELATED INSTITUTIONS.
NHLBI PARTICIPATED IN THE LAST
ANNOUNCEMENT, PAR18901 IN AUGUS.
OF THE 21 NHLBI-RELATED
APPLICATIONS SUBMITTED, 11 WERE
SCORED AND THREE HIGHLY
MERITORIOUS APPLICATIONS WERE
SELECTED FOR CO-FUNDING
CONSIDERATIONS.
THE THREE HIGHLY MERITORIOUS
APPLICATIONS, JUST TO GIVE YOU A
FLAVOR OF THESE, FOCUSED ON
BUILDING SUSTAINABLE AND
COLLABORATIVE RESEARCH TRAINING
INFRASTRUCTURE IN THE CARIBBEAN,
IN CENTRAL AMERICA, AND SOUTH
AMERICA.
IMPORTANTLY, WITHOUT NHLBI'S
PARTICIPATION, CRITICAL GLOBAL
HEART, LUNG, BLOOD, SLEEP
RESEARCH PROGRAMS LIKE THESE
WOULD NOT BE SUPPORTED DUE TO
FOGARTY'S LIMITED BUDGET THAT
NOW FOCUSES ONLY ON
CROSS-CUTTING HEALTH RESEARCH
PRIORITIES.
I'LL PAUSE HERE AND ENTERTAIN
ANY QUESTIONS OR COMMENTS AND
SUGGESTIONS YOU HAVE FOR US.
>> DR. MENSAH, I HAD A QUESTION
RELATED TO -- YOU SAID THIS WAS
LINKED WITH TWO OTHERS.
WHAT ARE THE OTHER TWO
COMPONENTS?
>> YES.
SO THE 2878 AND 2879 ARE THE D4R
AWARDS.
THE PURPOSE OF THE EMERGING
GLOBAL LEADER AWARD IS TO
PROVIDE RESEARCH SUPPORT AND
PROTECTED TIME ABOUT THREE TO
FIVE YEARS TO EARLY CAREER
SCIENTISTS FROM THE LOW AND
MIDDLE INCOME COUNTRIES WHO HOLD
JUNIOR FACULTY POSITIONS IN
ORDER TO AFFORD THEM THE TIME TO
DO RESEARCH.
2878 AND 2879, ONE BEING
CLINICAL TRIAL REQUIRED AND
CLINICAL TRIAL NOT ALLOWED.
>> THANK YOU.
>> AGAIN, 2878 REQUIRES A
CLINICAL TRIAL.
2879 DOES NOT ALLOW CLINICAL
TRIALS.
I DON'T SEE ANY QUESTIONS IN THE
CHAT BOX SO I'LL WAIT FOR YOUR
SIGNAL.
>> ALL THE VOTES ARE IN FOR
2677.
WAITING FOR THE ADDITIONAL VOTE
FOR 2678 AND 2679.
I HAVE NEARLY ALL THE VOTES FOR
ALL THREE CONCEPTS.
I'LL PAUSE HERE TO ALLOW THE
REMAINING VOTES TO COME IN.
WE HAVE ALL OF THEM AND CAN
PROCEED TO THE NEXT CONCEPT.
>> GREAT.
THANKS, JEN.
I WILL PRESENT FIVE CONCEPTS,
BECAUSE THEY ARE ALL RELATED TO
THE GLOBAL ALLIANCE FOR CHRONIC
DISEASES MULTI-MORBIDITY
PROGRAM.
YOU WILL RECALL EARLIER THIS
MORNING, DR. GIBBONS SHOWED YOU
A SLIDE OF THE GECD PROGRAM THAT
HAD FUNDING CALLS FOR
HYPERTENSION, FUNDING CALLS FOR
DIABETES, FOR MENTAL HEALTH, FOR
CANCER.
WE THINK WE'VE MADE SUBSTANTIAL
IMPROVEMENT BY MOVING AWAY FROM
THE SINGLE DISEASE AND SINGLE
RISK FACTOR CONCEPT THAT COMES
OUT ONE PER FUNDING CALL INTO
CLUSTERS THAT SHOW THE THEMES
AND FOCAL AREAS OF RESEARCH
THREE YEARS AT A TIME, AND ALSO
IMPORTANTLY, THEMES THAT ADDRESS
MULTI-MORBIDITY RATHER THAN
SINGLE RISK FACTORS AND SINGLE
DISEASES.
SO IN THESE FIVE CONCEPTS, I'LL
TELL YOU -- I'LL FIRST GIVE YOU
A BACKGROUND AND THEN TELL YOU
THE CONCEPT NUMBER AND THE THEME
IT ADDRESSES AND THE YEARS FOR
WHICH THEY'RE GOING TO BE
FUNDED.
EACH OF THE CONCEPTS REQUIRES A
SEPARATE VOTE.
HOWEVER, THEY'RE ALL RELATED TO
THE NIH-WIDE GLOBAL ALLIANCE FOR
CHRONIC DISEASES, WHICH I
REFERRED TO AS GECD, AND IS THE
MULTI-MORBIDITY RESEARCH
PROGRAM.
THE PROGRAM TARGETS CHRONIC
DISEASES AND MULTIPLE
MORBIDITIES IN LOW AND MIDDLE
INCOME COUNTRIES, AND VERY
IMPORTANTLY FOR THE FIRST TIME,
AMERICAN INDIAN AND ALASKA
NATIVE POPULATION IN THE UNITED
STATES.
I'LL PROVIDE AN OVERVIEW NEXT
AND THEN ASK FOR YOUR VOTE ON
THE CLUSTERS OF THE CONCEPTS.
THE PRIMARY OBJECTIVE OF THE NIH
WIDE GECD PROGRAM IS TO SUPPORT
IMPLEMENTATION RESEARCH THAT IS
FOCUSED ON ADDRESSING COMMON
RISK FACTORS FOR
NON-COMMUNICABLE DISEASES IN LOW
AND MIDDLE INCOME COUNTRIES AND
AMERICAN INDIAN AND ALASKA
NATIVE AND TRIBAL NATION
POPULATIONS IN THE U.S.
NOW, IN OTHER COUNTRIES THAT ARE
PARTNERS WITH US, SUCH AS
CANADA, AUSTRALIA AND NEW
ZEALAND, THEY'VE ALSO AGREED TO
FOCUS RESEARCH FUNDING ON
INDIGENOUS AND FIRST NATION
PEOPLES IN THEIR COUNTRIES.
THIS INITIATIVE IN COLLABORATION
WITH PARTICIPATING NIH ICs
SUPPORT INNOVATIVE APPROACHES TO
IDENTIFY, TO UNDERSTAND,
DEVELOP, AND IMPLEMENT
STRATEGIES FOR OVERCOMING
BARRIERS TO THE ADOPTION,
ADAPTATION, THE INTEGRATION AND
THE SCALEUP AND SPREAD AND
SUSTAINMENT OF EVIDENCE-BASED
INNOVATIONS, TOOLS, POLICIES,
STRATEGIES AND GUIDELINES.
STUDIES THAT ADVANCE
DISSEMINATION AND IMPLEMENTATION
RESEARCH METHODS AND MEASURES
AND THOSE THAT ENABLE
INCORPORATION OF DIGITAL
INNOVATION TOOLS ARE ENCOURAGED.
ESTABLISHED IN 2009, THE GECD IS
AN ALLIANCE OF AROUND 15 HEALTH
RESEARCH FUNDING AGENCIES FROM
AROUND THE WORLD THAT DEVELOP
AND FACILITATE INNOVATIVE
RESEARCH COLLABORATIONS BETWEEN
LOW AND MIDDLE INCOME COUNTRIES,
AND HIGH INCOME COUNTRIES IN THE
FIGHT AGAINST THESE CHRONIC
CONDITIONS.
NHLBI LEADERSHIP AND
PARTICIPATION IN THIS PROGRAM IS
CRUCIAL BECAUSE NEW NIH GECD
NICHE
INITIATIVES WILL HELP LEVERAGE
THE PROOF OF CONCEPT SUCCESSES
DEMONSTRATED IN EARLIER GECD
STUDIES WHICH IDENTIFY IDEAL
STRATEGIES THAT ARE RIGHT FOR
NATIONAL SCALEUP AND SPREAD.
THE STRATEGIC INVESTMENTS WE
MAKE AND NHLBI'S LEADERSHIP
WOULD LIKELY LEVERAGE ADDITIONAL
RESOURCES FOR GLOBAL HEALTH
RESEARCH FROM OTHER GECD
INVESTMENTS AND OTHER
ORGANIZATIONS SUCH AS THE
EUROPEAN COMMISSION AND THE
WORLD BANK.
THE NHLBI'S FACILITATION IS
NEEDED TO DEVELOP RESEARCH
CAPACITY IN THESE COUNTRIES AND
ESPECIALLY IN UNDERSERVED
POPULATIONS IN HIGH INCOME
COUNTRIES FOR THE PREVENTION AND
TREATMENT OF HEART, LUNG, BLOOD
AND SLEEP DISORDERS.
IN SUMMARY, INTEREST IN THIS
PROGRAM CLEARLY DRIVEN BY NHLBI
STRATEGIC VISION OBJECTIVE
6 THAT WOULD HELP OPTIMIZE
CLINICAL AND IMPLEMENTATION
RESEARCH TO IMPROVE HEALTH AND
REDUCE DISEASE.
SO FOR THE VOTING, THE FIRST
CONCEPT WHICH IS CONCEPT 2788,
IT USES THE R01 CLINICAL TRIAL
OPTIONAL MECHANISM AND IT
FOCUSES SPECIFICALLY ON CRITICAL
LIFE STAGES AND KEY TRANSITIONS.
ITS PLAN FOR FY 23 AND THE
FUNDING IS DESIGNED TO SUPPORT
RESEARCH THAT FOCUSES ON
ADDRESSING COMMON RISK FACTORS
THROUGH INNOVATIONS THAT IMPROVE
HEALTH OVERALL AND LIFESTYLE
BEHAVIORS IN INFANCY AND
CHILDHOOD, IN ADOLESCENCE,
PREGNANCY, OLDER ADULTS, ALL THE
RELATED TRANSITIONS ACROSS THESE
PHASES.
SO THAT'S CONCEPT 2788.
AND I'LL PAUSE HERE FOR ANY
QUESTIONS OR COMMENTS YOU HAVE
ON THIS CONCEPT AND FOR YOUR
VOTE.
>> SINCE I'M NOT HEARING OR
SEEING CONCEPTS, WE'RE ALMOST
READY TO MOVE ON TO THE NEXT
CONCEPT.
>> THAT'S GREAT.
>> I'M WAITING FOR ONE VOTE.
>> GREAT.
>> OKAY.
WE CAN PROCEED TO THE NEXT ONE
IN THIS SERIES.
>> I'LL PRESENT THE NEXT TWO,
CONCEPTS 2789, WHICH USES THE
R01 CLINICAL TRIALS OPTIONAL,
AND CONCEPT 2790.
THIS TIME BOTH FOCUS ON URBAN
ENVIRONMENTS AND CLIMATE HEALTH.
WITH ADDITIONAL EMPHASIS ON THE
RISK AND EXPOSURES LINKED TO
URBANIZATION AND RELATED HEALTH
INEQUITIES AND THE DEVELOPMENT
OF ENVIRONMENTALLY SUSTAINABLE
INTERVENTIONS.
SO THAT'S THE FOCUS FOR THESE
TWO CONCEPTS.
AND I'LL PAUSE HERE FOR YOUR
COMMENTS, YOUR SUGGESTIONS AND
YOUR VOTE.
>> WE'RE JUST ABOUT READY TO
MOVE ON.
OKAY, AND WE CAN ADVANCE TO THE
NEXT ONE.
>> GREAT.
THANK YOU, JEN.
THE FOURTH AND THE FINAL
CONCEPT, CONCEPT 2777 AND 2778,
TO BE FUNDED IN FY 2025.
FOCUS ON MULTI-MORBIDITIES AS A
WHOLE.
THEY ADDRESS MECHANISMS THAT
SUPPORT IMPLEMENTATION RESEARCH
ON WHEN, FOR WHOM AND UNDER WHAT
CIRCUMSTANCES COST-EFFECTIVE
PATIENT-CENTERED MODELS CAN
IMPROVE INTEGRATED CARE FOR
PATIENTS WHO HAVE NCD
MULTI-MORBIDITIES IN LOW AND
MIDDLE INCOME COUNTRIES, AND IN
UNDERSERVED POPULATIONS IN HIGH
INCOME COUNTRIES AS I DESCRIBED.
AGAIN, I'LL PAUSE HERE FOR YOUR
QUESTIONS, YOUR COMMENTS, YOUR
SUGGESTIONS, AND YOUR VOTE,
AGAIN ON 2777 AND 2778.
>> LOOKING GOOD FOR 2678.
I'LL GIVE EVERYONE A MOMENT TO
COMPLETE THEIR VOTE FOR THE
OTHER CONCEPT AS WELL.
THE VOTES ARE ALSO IN FOR 2678.
>> THANK YOU, JEN.
I BELIEVE THAT'S THE LAST PAIR
I'LL BE PRESENTING AND I'LL TURN
IT BACK OVER TO DR. MOEN,
PLEASE.
>> YES.
SO I BELIEVE SOMEBODY IS GOING
TO BE PRESENTING THESE FOR DARA.
>> I AM, DR. MOEN.
IT'S JULIE.
>> THANK YOU.
>> SO THE DIVISION OF EXTRAMURAL
RESEARCH ACTIVITIES WILL PRESENT
THREE INITIATIVES TODAY.
THE FIRST INITIATIVE, CONCEPT ID
NUMBER 2713 IS THE BUILDUP TRUST
PRIZE CHALLENGE.
THE OBJECTIVE -- A MAJOR
OBJECTIVE IS TO INCREASE
RESEARCH PARTICIPATION, ADOPTION
OF EXISTING AND NEW TOOLS, AND
STRATEGIES TO DETECT, TREAT AND
MONITOR DISEASES AND DISORDERS
BY IMPROVING ENGAGEMENT WITH
UNDERSERVED POPULATIONS.
I WILL DESCRIBE IN BRIEF THE
RATIONALE AND FORMAT.
BY USING A PRIZE CHALLENGE, THE
GOAL IS TO ENGAGE DIRECTLY WITH
NON-TRADITIONAL INNOVATORS SUCH
AS UNDERSERVED COMMUNITY
MEMBERS, AND TO ENGAGE WITH
ADVOCATES WHO DO NOT NORMALLY
APPLY FOR NIH GRANTS, AND TO
GENERATE NEW IDEAS ON ADDRESSING
TRUST IN UNDERSERVED
COMMUNITIES.
THE CHALLENGE CONSISTS OF TWO
PHASES.
PHASE 1 WILL SOLICIT NEW IDEAS
THAT WILL ADDRESS ONE OR MORE
BARRIERS TO TRUST IN A SPECIFIC
COMMUNITY TO BE REFINED BY EACH
SOLVER OR TEAM MEMBER.
IN PHASE TWO, SOLVERS WILL
IMPLEMENT THEIR PROPOSED
SOLUTION.
THE PHASE ONE SUBMISSION WILL
CONSIST OF A WHITE PAPER THAT
INCLUDES INFORMATION ON THE TEAM
MEMBERS, COMMUNITY OR GROUPS
THAT WILL BENEFIT FROM THE
PROPOSED SOLUTION, DESCRIPTION
OF BARRIERS, STATEMENT OF GAP
AND OPPORTUNITY, PROPOSED
SOLUTIONS, AND A PLAN TO
IMPLEMENT A SOLUTION AND ADDRESS
THE GAP.
PHASE ONE WILL CULMINATE IN A
DEMO DAY HOSTED BY THE NHLBI IN
WHICH THE TOP PHASE ONE SOLVERS
WILL BE ASKED TO PARTICIPATE.
THE PURPOSE IS THREE FOLD.
NUMBER ONE, TO SHOWCASE THE
EXCITING SOLUTIONS THAT WERE
SUBMITTED.
NUMBER TWO, TO PROVIDE AN
OPPORTUNITY FOR SOLVERS AND
STAKEHOLDERS TO INTERACT TO
SHARE IDEAS, AND NUMBER THREE,
TO SELECT PHASE ONE FINALISTS.
PHASE TWO WILL CONSIST OF A
REDUCTION TO PRACTICE, WHERE
SOLVERS ARE ASKED TO IMPLEMENT
THEIR PROPOSED SOLUTIONS AND
PROVIDE METRICS OF SUCCESS.
THE OPTIMAL CRITERIA FOR SUCCESS
WILL BE SPECIFIC TO EACH
SOLUTION.
SCORING WILL GENERALLY TAKE INTO
ACCOUNT FEATURES INCLUDING
COMPLETION OF PROPOSED PLAN,
DESCRIPTION OF BARRIERS
ENCOUNTERED AND HOW THOSE WERE
LAN DELLED, DESCRIPTION AND
DEMONSTRATION OF IMPACT AND THE
POSSIBILITY FOR CONTINUATION
INTO THE FUTURE.
DO ANY MEMBERS HAVE ANY
QUESTIONS OR WISH TO DISCUSS
THIS INITIATIVE?
IF NOT, WE CAN HAVE MEMBERS
VOTE.
SO I'M NOT HEARING OR SEEING
ANY, SO I THINK WE CAN GO AHEAD
AND VOTE.
>> VOTING IS TAKING PLACE RIGHT
NOW.
WE'RE JUST ABOUT READY TO MOVE
ON.
ALL THE VOTE ARE IN AND WE CAN
PROCEED.
>> THANK YOU.
SO THE SECOND AND THIRD
INITIATIVES, I WILL PRESENT
TOGETHER, AND THEY ARE SECONDARY
SIGN-ONS, CONCEPT ID NUMBER
2710, AND CONCEPT ID NUMBER
2711.
SBIR STTR COMMERCIALIZATION
READINESS PILOT PROGRAM,
TECHNICAL ASSISTANCE AND LATE
STAGE DEVELOPMENT SB1 CLINICAL
TRIAL NOT ALLOWED AND
SB1 CLINICAL TRIAL REQUIRED
R42 AND R44.
SO THE 2011 REORGANIZATION OF
THE SBIR/STTR PROGRAM
FACILITATED AN EXPANSION OF THE
COMMERCIALIZATION READINESS
PILOT PROGRAM TO THE NIH.
THE COMMERCIALIZATION READINESS
PILOT PROGRAM IS DESIGNED TO
FACILITATE THE TRANSITION OF
PREVIOUSLY FUNDED SBIR/STTR FACE
2B PROJECTS TO COMMERCIALIZATION
STAGE BY PROVIDING ADDITIONAL
SUPPORT FOR LATER STAGE
TECHNICAL ASSISTANCE AND R & D
ACTIVITIES.
AND ALSO ALLOWS PHASE TWO 2B
GRANTEES TO RECEIVE SUPPORT
CONCURRENTLY TO THE PARENT
AWARD.
DUE TO ITS UNIQUE SB1 MECHANISM,
AWARDS UNDER THE CRP ARE NOT
SUBJECT TO THE SAME
SUBCONTRACTING RESTRICTIONS AS
R42/R44 AWARDS.
THIS ALLOWS THE CRP AWARDS TO
COVER THE COST OF ACTIVITIES
THAT ARE NOT TYPICALLY SUPPORTED
THROUGH PHASE 2 OR PHASE 2B
GRANTS OR CONTRACTS BUT ARE
NECESSARY FOR PRODUCT
DEVELOPMENT.
THESE ACTIVITIES INCLUDE BUT ARE
NOT LIMITED TO IND IDE ENABLING
STUDIES, CHEMISTRY MANUFACTURING
AND CONTROL ACTIVITY FOR IND
ENABLING TESTS, DESIGN AND
VALIDATION STUDIES FOR DEVICES
AND SOFTWARE, CLINICAL TRIAL
DESIGN AND PLANNING, ANIMAL
STUDIES TO DEVELOP NEW SURGICAL
TECHNIQUES RELEVANT TO A NEW
DEVICE, AND DEVELOPMENT
VALIDATION OF ASSAYS FOR
CLINICAL TRIALS.
THE NHLBI STARTED PARTICIPATING
IN THE CRP AS EARLY AS 2015, AND
CONTINUED ITS PARTICIPATION WHEN
THE PROGRAM WAS RE-AUTHORIZED IN
2019 THROUGH THE JOHN S. MCCAIN
NATIONAL DEFENSE AUTHORIZATION
ACT.
SINCE FISCAL YEAR '20, WE HAVE
RECEIVED A TOTAL OF
44 APPLICATIONS AND MADE A TOTAL
OF SEVEN AWARDS THROUGH THE CRP
FUNDING OPPORTUNITY
ANNOUNCEMENTS.
POSITIVE OUTCOMES HAVE BEEN
OBSERVED FROM RECIPIENTS OF CRP
AWARDS.
FOR EXAMPLE, FOLLOWING THEIR
NHLBI FUNDED CRP AWARD WHICH WAS
USED TO DEVELOP THEIR
INTELLECTUAL PROPERTY STRATEGY,
A COMPANY FOCUSED ON DEVELOPING
PLATELET-BASED CELLULAR
THERAPIES WENT ON TO RECEIVE A
CONTRACT FROM BARDA, VALUED UP
TO $506 MILLION, TO DEVELOP
HUMAN STEM CELL DERIVED
PLATELETS AS A MEDICAL COUNCIL
AT THE MEASURE TO RADIOLOGICAL
AND NUCLEAR EXPOSURES IN 2019.
TWO YEARS LATER, THEY WENT ON TO
RAISE $75.5 MILLION IN SERIES B
FUNDING.
ANOTHER EXAMPLE WITH A COMPANY
WITH NHLBI FUNDING WHICH SPAWNED
A SPINOUT COMPANY RECENTLY
OBTAINED 501K CLEARANCE FOR
THEIR NHLBI FUNDED ULTRASOUND
SYSTEM.
THEIR NHLBI-FUNDED CRP AWARD WAS
USED TO SUPPORT THE 3D PRINTING
AND MANUFACTURING OF THE
COMPONENTS TO BETTER COMPLY WITH
FDI GUIDELINES.
FINALLY, A MEDICAL DEVICE
COMPANY FOCUSED ON THE
DEVELOPMENT OF BLOOD-BASED
DIAGNOSTICS RECEIVED THE FDA
ACKNOWLEDGMENT OF EMERGENCY USE
NOTIFICATION FOR ITS TEST FOR
DETECTING SARS-COV-2.
THE NHLBI-FUNDED CRP AWARD WAS
USED TO SUPPORT THE DEVELOPMENT
OF THE REGULATORY STRATEGY AND
MANUFACTURING ACTIVITY FOR THE
EVENTUAL COMMERCIALIZATION FOR
THEIR DEVICE.
ACOMPLETE THEIR PRODUCT
DEVELOPMENT ACTIVITIES AND
MAXIMIZE THE INSTITUTE'S EFFORTS
TO PROMOTE THE TRANSLATION OF
HEART, LUNG, BLOOD AND SLEEP
TECHNOLOGY.
WE RECOMMEND PRIORITIZING
CONTINUED SECONDARY
PARTICIPATION AND FUNDING OF
THIS PROGRAM.
I'LL STOP HERE AND DO ANY
MEMBERS HAVE ANY QUESTIONS OR
WISH TO DISCUSS THE INITIATIVE?
OTHERWISE WE CAN HAVE VOTING.
I'M NOT SEEING ANY QUESTIONS OR
HEARING DISCUSSION.
>> ALL THE VOTES ARE IN FOR
CONCEPT 2710.
I'M GOING TO PAUSE TO MAKE SURE
WE HAVE ALL THE VOTES FOR 2711.
ALL THE VOTES ARE IN FOR 2711.
>> GREAT.
THAT ENDS THAT.
I'LL TURN IT BACK OVER TO YOU,
DR. MOEN.
>> THANK YOU.
MASTERFULLY DONE.
BEFORE WE END THE CONCEPT
CLEARANCE PIECE, I JUST WANTED
TO LET EVERYBODY KNOW THAT IF
YOU HAVE ANY QUESTIONS ABOUT THE
CONCEPTS THAT WERE LISTED FOR
INFORMATION ONLY IN THE
MATERIALS THAT WERE PRESENTED ON
THE ACD, THIS IS A GOOD TIME FOR
YOU TO ASK ABOUT THEM.
THERE WERE THINGS IN THERE THAT
I HOPE YOU DID AT LEAST BECOME
AWARE OF OUR INVOLVEMENT IN THE
HEAL PROGRAM, OUR INVOLVEMENT IN
IMPROVE AND INCLUDE.
THERE'S A LOT OF THINGS IN THERE
AND THE REASON OF COURSE THAT
THEY'RE FOR INFORMATION ONLY IS
THAT THE MAJORITY OF THESE,
ALTHOUGH NOT ALL OF THEM, ARE
NIH OD PROGRAMS THAT COME FROM
OTHER PEOPLE'S MONEY THAT WE
SIGN ON TO AS PART OF BEING A
GOOD CITIZEN BUT ALSO FOR THE
NHLBI TO BE ABLE TO SUPPORT
THINGS IN OUR MISSION THAT FALL
UNDER THOSE PARTICULAR HEADINGS.
SO DON'T FLE GLECT NEGLECT.
DID ANYBODY HAVE ANY QUESTIONS
ABOUT THOSE?
NOT SEEING ANYTHING IN THE CHAT.
OR ANY QUESTIONS OR HANDS
RAISED.
DR. GIBBONS, DO YOU HAVE ANY
QUESTIONS OR ANY DIALOGUE THAT
YOU WISH TO ENGAGE YOUR
COUNCILMEMBERS ON BEFORE WE
ADJOURN THE MEETING?
I THINK YOU'RE STILL MUTED,
DR. GIBBONS.
THERE YOU GO.
>> THANKS.
FOR SOME REASON I'M NOT AS ADEPT
WITH THE BUTTONS ANYMORE.
NO, JUST -- REALLY JUST A NOTE
OF, AGAIN, GRATITUDE FOR SHARING
YOUR TIME, EXPERTISE, AND
ENGAGEMENT.
YOU'VE GIVEN SOME REALLY GOOD
INPUT AND ADVICE THAT WE VERY
MUCH APPRECIATE TO BE WITH YOUR
COMMENTS IN THE INITIATIVES, AND
SO AGAIN, THANK YOU.
BACK TO YOU, LAURA.
>> THANK YOU, DR. GIBBONS.
SO I ALSO WANT TO EXTEND MY
THANKS TO EVERYBODY AND TO THOSE
AD HOC MEMBERS WHO WERE WILLING
TO COME AND SHARE THEIR TIME
WITH US THIS ROUND.
I LOOK FORWARD TO OUR NEXT
MEETING.
I THINK I SHOULD JUST MENTION
THAT WE HAVE THE AUGUST MEETING
WHICH IS GRANTS BUSINESS ONLY SO
IT'S CLOSED SESSION ONLY.
WE'LL JUST BE DISCUSSING
GRANT-RELATED BUSINESS THAT
NEEDS TO BE CONCLUDED BEFORE THE
END OF THE FISCAL YEAR, BUT THE
BIG EVENT THAT'S COMING UP IS IN
SEPTEMBER, OUR COMBINED MEETING
WITH THE BOARD OF EXTERNAL
EXPERTS, AND WE ARE HOPING TO DO
THAT MEETING IN PERSON THIS
YEAR.
SO PLEASE DO STAY TUNED FOR
ADDITIONAL FUN, AND
ANNOUNCEMENTS.
I THINK WE'RE GOING TO ENJOY
THOSE DISCUSSIONS A GREAT DEAL,
AND WE'RE BUSY IN THE PLANNING
PHASE SO FURTHER INFORMATION
WILL BE FORTHCOMING.
DR. GIBBONS, YOU MAY CLOSE THE
MEETING.
>> WELL, THANK YOU SO MUCH TO
THE 297TH MEETING OF THE
NATIONAL HEART, LUNG AND BLOOD
ADVISORY COUNCIL IS NOW
ADJOURNED.
THROUGH SO MUCH.
>> THANKS, EVERYBODY.
>> BYE, ALL.
>> BYE.
THANKS, DAVID.
>> BYE.
THANK YOU.
>> THANK YOU, TINA.
>> BYE-BYE.
NICE TO SEE YOU ALL.
>> YOU TOO, MARTHA.
THANKS.
>> BYE, EVERYONE.