>>GOOD MORNING.
IF THIS SEEMS WEIRD TO YOU,
IMAGINE HOW I FEEL.
I HAVE ATTENDED OVER 50 SESSIONS
OF THE COUNCIL, AND I'VE ONLY
OPENED MY MOUTH TO SPEAK ON ONE
OCCASION WHEN DR. FAUCI WAS IN
THAILAND RECEIVING AN AWARD, HE
PRE-TAPED REMARKS BUT I HAD TO
APPROVE THE MINUTES.
YOU'LL HEAR MORE FROM ME TODAY
THAN THAT.
WE'RE MEETING VIRTUALLY TODAY AS
WE PLAN TO DO EVERY JANUARY
COUNCIL, REGARDLESS OF COVID
STATUS.
I WOULD BE VERY PLEASED IF WHEN
IT COMES TO MAY IF A NEW
PERMANENT DIRECTOR COULD MAKE
THE DECISION THEN ABOUT WHETHER
WE MEET IN PERSON.
AS YOU KNOW, DURING THIS OPEN
SESSION, WE'RE JOINED BY
REPRESENTATIVES FROM
PROFESSIONAL AND LAY
ORGANIZATIONS WHO SHARE
INTERESTS IN ACTIVITIES IN
COMMON WITH THE MISSION OF THE
INSTITUTE.
AS ALWAYS, WE WELCOME THEM.
NEXT SLIDE PLEASE.
I WANT TO WELCOME SIX NEW
COUNCIL MEMBERS WHO ARE JOINING
US TODAY.
EMILY BROWN IS A NATIONAL
PATIENT ADVOCATE, FOUNDER AND
CHIEF EXECUTIVE OFFICER OF FREE
FROM MARKET, A DIGITAL HEALTH
AND e-COMMERCE COMPANY,
WORKING TO PROVIDE AFFORDABLE
INCLUSIVE ACCESS TO THE FOODS
AND RESOURCES PEOPLE NEED TO
IMPROVE THEIR HEALTH.
DR. MARY ESTES HOLDS THE CULLEN
FOUNDATION ENDOWED CHAIR OF
MOLECULAR AND HUMAN VIROLOGY,
DISTINGUISHED SERVICE PROFESSOR,
DEPARTMENT OF MOLECULAR BIOLOGY
AND MICROBIOLOGY, DEPARTMENT OF
MEDICINE, GASTROENTEROLOGY AND
HEPATOLOGY AND INFECTIOUS
DISEASES AT BAYLOR COLLEGE OF
MEDICINE.
DR. JAMES GERN IS PROFESSOR OF
PEDIATRICS AND MEDICINE,
UNIVERSITY OF WISCONSIN SCHOOL
OF MEDICINE AND PUBLIC HEALTH IN
MADISON, AND VICE CHAIR FOR
RESEARCH IN DEPARTMENT OF
PEDIATRICS.
DR. LAWRENCE MOREL, PROFESSOR
AND CHAIR OF DEPARTMENT OF
MICROBIOLOGY, UNIVERSITY OF
TEXAS HEALTH CENTER, SAN
ANTONIO.
DR. GUY PALMER IS PROFESSOR OF
PATHOLOGY AND INFECTIOUS
DISEASES, JAN AND JACK CREIGHTON
ENDOWED CHAIR AT WASHINGTON
STATE UNIVERSITY.
GUY SERVES AS SENIOR DIRECTOR OF
GLOBAL HEALTH FOR THE WASHINGTON
STATE UNIVERSITY SYSTEM.
WE ALSO HAVE A NEW EX OFFICIO
MEMBER OF COUNCIL, DR. DANIEL
JERNIGAN, ACTING DIRECTOR OF THE
NATIONAL CENTER FOR EMERGING AND
ZOONOTIC INFECTIOUS DISEASES AT
CDC.
WELCOME TO YOU ALL.
WE'RE DELIGHTED TO HAVE YOU WITH
US TODAY.
THE FIRST ITEM OF BUSINESS IS TO
REVIEW AND APPROVE THE MINUTES
FROM THE LAST MEETING.
YOU SHOULD ALREADY HAVE SEEN A
COPY OF THE MINUTES IN THE
ELECTRONIC COUNCIL BOOK.
ARE THERE ANY CORRECTIONS TO THE
MINUTES?
ARE THERE ANY CONCERNS ABOUT
CONCEPTS PRESENTED AT THE
PREVIOUS MEETING?
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL.
>>SO MOVED.
>>IS THERE A SECOND?
>>SECOND.
>>ALL THOSE IN FAVOR OF THE
MINUTES PLEASE SAY AYE.
>>AYE.
>>ANY OPPOSED?
THE MINUTES STAND AS APPROVED.
THANK YOU.
AS WE MOVE INTO THE MAIN BODY OF
THE PRESENTATION, I WANT TO
MENTION THAT WE'RE FOLLOWING A
FORMAT THAT DR. FAUCI HAS USED
FOR DECADES.
IT INVOLVES WORK ON THE PART OF
NUMEROUS EMPLOYEES OF NIAID BUT
THEY ARE ALL WORKING ON UNDER
THE DIRECTION OF GREG FOLKERS.
MANY OF YOU NOT IN THE IMMEDIATE
OFFICE OF THE DIRECTOR MAY NOT
KNOW GREG.
HE KEEPS A LOW PROFILE.
BUT FOR 25 YEARS, HE HAS BEEN
WORKING DIRECTLY FOR DR. FAUCI,
AND I SUSPECT THAT THERE ARE
FEW, IF ANY, PRESENTATIONS THAT
HAVE COME OUT OF HIS OFFICE THAT
HAVEN'T HAD THE FINGERPRINTS OF
GREG FOLKERS.
I MENTIONED HIM PARTICULARLY
BECAUSE OF HIS KEY ROLE IN
PREPARING THESE REMARKS BECAUSE
TOMORROW IS HIS LAST DAY AS A
FEDERAL EMPLOYEE.
I WILL LATER SHOW A PICTURE OF
HIM BUT IN FACT THAT IS GOING TO
BE SOMETHING OF A THEME FOR THIS
PRESENTATION, WE HAVE NUMEROUS
TRANSITIONS AND I'M SURE OVER
THE NEXT SEVERAL YEARS THERE
WILL BE MORE TO COME.
THE FIRST AND MOST SIGNIFICANT
OF COURSE IS THE DEPARTURE FROM
FEDERAL SERVICE OF TONY FAUCI.
HE SERVED AS THE NIH NIAID
DIRECTOR FOR 38 YEARS, AND SPENT
54 YEARS AS NIAID
PHYSICIAN-SCIENTIST.
HE LEAVES AN INDELIBLE MARK ON
SCIENCE AND GLOBAL HEALTH.
HERE IS HOW PRESIDENT BIDEN PUT
IT.
BECAUSE OF DR. FAUCI'S MANY
CONTRIBUTIONS TO PUBLIC HEALTH,
LIVES HERE IN THE UNITED STATES
AND AROUND THE WORLD HAVE BEEN
SAVED.
AS HE LEAVES HIS POSITION IN THE
U.S. GOVERNMENT, I KNOW THE
AMERICAN PEOPLE AND ENTIRE WORLD
WILL CONTINUE TO BENEFIT FROM
DR. FAUCI'S EXPERTISE IN
WHATEVER HE DOES NEXT.
WHETHER YOU MET HIM PERSONALLY
OR NOT HE HAS TOUCHED ALL
AMERICANS' LIVES WITH HIS WORK.
I EXTEND MY DEEPEST THANKS FOR
HIS PUBLIC SERVICE TO THE UNITED
STATES OF AMERICA AND THE
COUNTRY IS STRONGER FOR HIS
SERVICE, MORE RESILIENT AND
HEALTHIER BECAUSE OF HIM.
ON DECEMBER 16, NIH STAGED A
FAREWELL EVENT FOR DR. FAUCI,
SHOWN IN THIS SLIDE HERE.
WE HAD PRESENTATIONS FROM DR.
LARRY TABAK, JOHN GALLIN, CLIFF
LANE, FRANCIS COLLINS, AND
CHRISTINE GRADY.
AFTER THE TESTIMONIALS, NIH
ACTING CHIEF OF STAFF JOHN
BURKLOW IT A CONVERSATION ON
STAGE WITH DR. FAUCI, REFLECTING
ON HIS LONG AND REMARKABLE
CAREER.
FOLLOWING THAT, WE HAD CLOSING
REMARKS FROM DR. FAUCI HIMSELF
AND THE ENTIRE EVENT WAS VERY
MOVING.
YOU CAN SEE HERE THE STANDING
OVATION AT THE COMPLETION OF
THIS CEREMONY.
NOW, YOU SHOULD KNOW THERE'S A
GLOBAL SEARCH UNDERWAY TO FIND A
REPLACEMENT FOR DR. FAUCI, AS
THE INSTITUTE DIRECTOR.
THE ANNOUNCEMENT WENT OUT ON
NOVEMBER 16.
CLOSING DATE WAS THEORETICALLY
JANUARY 17 BUT IN FACT
APPLICATIONS WILL BE ACCEPTED
UNTIL THE POSITION IS FILLED.
BUT JANUARY 17 WAS THE TIME AT
WHICH THE SEARCH COMMITTEE CAN
BEGIN REVIEWING THE APPLICATIONS
AND BEGINNING TO DO INTERVIEWS.
SO, THE PROCESS IS UNDERWAY.
NOW I'M GOING TO TALK ABOUT
OTHER HIGH LEVEL APPOINTMENTS
AND DEPARTURES.
FIRST IS RENEE, THE FIRST ARPA-H
DIRECTOR, SHE COMES FROM A
BIOTECH COMPANY IN BOSTON, BUT
SHE'S WORKED IN THE PAST FOR
DARPA AND THE IARPA,
INTELLIGENCE ARPA, WELL FAMILIAR
WITH THE PROGRAM SHE'S GOING TO
BE LEADING AT ARPA-H.
WE HAD THE OPPORTUNITY TO HEAR
FROM HER THIS MORNING.
SHE'S AGREED TO SHARE HER
VISION.
WE HAVE JONI RUTTER CHOSEN TO
LEAD NCATS, ACTING DIRECTOR OF
NCATS AND BEFORE THAT DEPUTY
DIRECTOR.
APPOINTMENT RECENTLY OF NINA
SCHOR, DEPUTY DIRECTOR FOR
INTRAMURAL RESEARCH REPLACING
MICHAEL GOTTESMAN WHO STEPPED
DOWN LAST AUGUST AFTER MANY
YEARS.
ROGER GLASS STEPPED DOWN AS THE
DIRECTOR OF THE FOGARTY
INTERNATIONAL CENTER, HE'S HELD
THAT POSITION SINCE 2006, MAKING
HIM THE LONGEST-SERVING DIRECTOR
OF THE FOGARTY INTERNATIONAL
CENTER, AND HE'S LEFT AN
ENORMOUS MARK ON THE
INTERNATIONAL PROGRAMS OF THE
NIH.
AND THE CENTRAL -- CENTER FOR
INFORMATION TECHNOLOGY DIRECTOR
AND CHIEF INFORMATION OFFICER
ANDREA NORRIS HAS ALSO STEPPED
DOWN FROM THAT POSITION, SHE HAS
A $1.7 BILLION BUDGET TO PROVIDE
INFORMATION TECHNOLOGY SERVICES
TO THE INSTITUTES AT NIH.
COMING TO NIAID GRAY HANDLEY,
ASSOCIATE DIRECTOR FOR
INTERNATIONAL RESEARCH AFFAIRS,
RETIRED AT THE END OF LAST YEAR.
GRAY CAME TO NIAID IN 2006, A
FEW MONTHS AFTER I DID, AND OVER
THE COURSE OF THE YEARS SINCE
THEN WE TRAVELED THE WORLD
TOGETHER, HE'S BECOME A CLOSE
PERSONAL FRIEND, AND HE HAS
GREATLY EXPANDED AND IMPROVED
NIAID'S INTERNATIONAL PORTFOLIO.
WHEN HE CAME TO ME AND TOLD ME
HE WAS RETIRING, I SAID, PLEASE,
GRAY, ONE MORE YEAR.
HE SAID NO, THE TIME HAD COME,
BUT HE HAS AGREED TO COME BACK
AS A CONTRACTOR FOR SPECIAL
PROJECTS.
NOW, I MENTIONED GREG FOLKERS
EARLIER.
THIS IS A PICTURE OF HIM.
HE WORKED DIRECTLY FOR DR. FAUCI
FOR 25 YEARS.
AND LORI DUPELL ALSO IN FEDERAL
SERVICE FOR OVER 30 YEARS, AND
IS A GIFTED EDITOR AND WRITER
WORKING WITH DR. FAUCI FOR MANY
YEARS NOW ON THE SCRIPTS OF THE
MANY OF HIS REMARKS, AND OF SOME
OF HIS PAPERS.
THE TWO OF THEM HAVE AGREED TO
COME BACK AS CONTRACTORS PARTLY
WORKING FOR NIAID, BUT PROBABLY
SPENDING MORE OF THEIR TIME
ACTUALLY WORKING STILL FOR DR.
FAUCI, IN HIS PRIVATE CAPACITY.
IN THE DIVISION OF EXTRAMURAL
ACTIVITIES, MATTHEW FENTON
STEPPED DOWN AT THE END OF THE
YEAR, KELLY POW IS NOW ACTING
DIRECTOR OF THE DIVISION, A
TUMULTUOUS TEN YEARS FOR
MATTHEW, GIVEN ZIKA, EBOLA, MORE
RECENTLY COVID OUTBREAKS KEPT
HIS DIVISION WORKING EXTRA TIME
THROUGHOUT HIS SERVICE.
IN THE DIVISION OF EXTRAMURAL
ACTIVITIES, GEORGE KENNEDY HAS
BEEN NAMED THE DIRECTOR OF THE
OFFICE OF ACQUISITIONS, HE HAS
WORKED IN NUMEROUS PARTS OF THAT
OFFICE OVER THE COURSE OF YEARS
AND IS A REAL EXPERT ON
GOVERNMENT CONTRACTING WHICH IS
A GOOD THING BECAUSE HE'S
REPLACING CHUCK GRUWE WHOSE 44
YEARS OF SERVICE AS CONTRACTING
OFFICER FOR NIAID MADE HIM A
RECOGNIZED GURU IN THAT
POSITION.
WE HAVE BEEN FORTUNATE TO NAME
DMID FOR THE RESPIRATORY DISEASE
BRANCH MICHAEL ICEN FROM
NORTHWEST UNIVERSITY, AN
INTERNATIONALLY ACKNOWLEDGED
EXPERT IN NUMEROUS RESPIRATORY
VIRUSES AND OTHER PATHOGENS.
WE'VE RECRUITED FOR DAIDS
VERNON -- ANDREW VERNON AS CHIEF
OF THE TB CLINICAL RESEARCH
BRANCH AFTER A LONG CAREER AT
CDC WHERE HE WORKED ON TB
AFFAIRS ON A GLOBAL BASIS, WILL
BRING ENORMOUS KNOWLEDGE TO THIS
POSITION.
IN THE DIVISION OF ALLERGY,
IMMUNOLOGY, AND TRANSPLANTATION,
JIM MCNAMARA HAS RETIRED, IN
HIS -- UNDER HIS LEADERSHIP THE
AUTOIMMUNITY CENTERS FOR
EXCELLENCE REALLY CAME TOGETHER
AS A FINELY TUNED NETWORK AND HE
CONTRIBUTED GREATLY TO THE
COURSE OF THE IMMUNE TOLERANCE
NETWORK.
EDEN GOLDMUNTZ IS NOW ACTING
DIRECTOR OF THAT BRANCH, SHE HAS
BEEN THE CHIEF OF
RHEUMATOLOGICAL DISEASE SECTION
IN THAT BRANCH FOR MANY YEARS.
MARY SMOLSGUS IN CLINICAL
RESEARCH IS LEAVING US -- EXCUSE
ME, IS THE DIRECTOR OF THE
OFFICE OF PLANNING AND
OPERATIONS SUPPORT.
>>ONE SECOND.
>>IN THE DIVISION OF CLINICAL
RESEARCH, MARY SMOLSKIS IS
DIRECTOR OF OFFICE OF PLANNING
AND OPERATIONS SUPPORT.
SHE CAME TO NIAID AND NIH IN
1985 AS A CLINICAL NURSE, SHE
HAS GONE ON TO BECOME LEAD
CLINICAL OPERATIONS MANAGER FOR
CATCH THIS THE FLUENCE, EBOLA,
SARS-COV-2, AND RUN STUDIES IN
MEXICO, LIBERIA, GUINEA, CONGO
AND MONGOLIA, SHE'S BEEN FAR AND
WIDE.
NOW CLIFF LANE RECEIVED THE 2022
PAUL VOCHER CAREER ACHIEVEMENT
MEDDLE AT HIS ANNUAL SERVICE TO
AMERICA MEDALS, REFERRED TO BY
PEOPLE IN THE KNOW AS THE
SAMMYS, THE AWARD IS CONSIDERED
THE OSCAR OF PUBLIC SERVICE.
IN ADDITION, ALEX ROSENTHAL HAS
BEEN RECOGNIZED BY PRESIDENTIAL
RANK AWARD FOR HIS SERVICE AS
THE NIAID CHIEF TECHNOLOGY
OFFICER.
THIS IS REALLY THE HIGHEST AWARD
FOR CIVIL SERVANTS PROVIDED BY
THE FEDERAL GOVERNMENT.
I'M PLEASED TO TELL YOU THAT
NIAID IS WINNER OF ONE OF THE
PATENTS FOR HUMANITY AWARD, THIS
WAS IN RECOGNITION OF THE WORK
OF OUR TECHNOLOGY TRANSFER AND
INTELLECTUAL PROPERTY OFFICE,
WHICH WORKED HARD WITH THE
INVESTIGATORS FROM VRC INCLUDING
MARTY GRAHAM FOR THEIR WORK
STABILIZING THE SPIKE PROTEIN OF
CORONAVIRUS WITH S2P MUTATIONS.
OVER THE YEARS, WE HAVE DONE
WELL WITH SCIENCE MAGAZINE'S
RECOGNITION OF TOP TEN
BREAKTHROUGHS IN 2022 THAT
AWARD, PRIME AWARD, WENT TO
JAMES WEBB SPACE TELESCOPE.
TWO RUNNER UP AWARDS RECOGNIZED
RESEARCH BY NIH INVESTIGATORS,
NIAID INVESTIGATORS, INCLUDING
MARTY AND OTHERS' WORK ON
RESPIRATORY SYNCYTIAL VACCINES,
CLOSE TO APPROVAL WE BELIEVE,
AND IMPLICATED EBV AS A
POTENTIAL CAUSE OF MULTIPLE
SCLEROSIS.
ON DECEMBER 8 WE HAD THE 9th
GLOBAL HEALTH WORKSHOP WITH THE
GATES FOUNDATION, HERE AT NIH.
AT THIS PLENARY SESSION AS YOU
SEE HERE BILL GATES HIMSELF MADE
KIND REMARKS ABOUT DR. FAUCI, IN
ADDITION HAD TAPED TRIBUTES FROM
PRESIDENT BILL CLINTON, W.H.O.
DIRECTOR TEDROS, AND OUR FRIENDS
FROM SOUTH AFRICA.
IT WAS ANOTHER VERY MOVING
CEREMONY.
NIH AND THE GATES FOUNDATION
HAVE COLLABORATED ON A NUMBER OF
PROJECTS AND CONTINUE TO DO SO
AFTER THIS MORNING PLENARY
SESSION WE SPENT THE REST OF THE
DAY MEETING TOGETHER TO TALK
ABOUT PROGRESS IN OUR JOINT
PROJECTS.
THIS SLIDE HIGHLIGHTS SOME OF
THE MEETINGS THAT WE, MEMBERS OF
THE SENIOR LEADERSHIP, HAVE HAD
WITH REPRESENTATIVES FROM
FOREIGN COUNTRIES.
WE'VE HAD IN-PERSON MEETINGS
WITH VISITOR FROM THE U.K.,
CANADA, INDIA, EUROPEAN UNION,
AUSTRALIA, POLAND, FRANCE,
W.H.O., KOREA, MALI AND ELSE
WHERE.
THIS IS A PICTURE UPPER LEFT
CORNER OF THE RECTOR OF THE
UNIVERSITY IN VAMAKO WHICH WITH
WE'VE HAD A RELATIONSHIP FOR
MANY YEARS, WE MET WITH HIM AS
WE HAVE WITH OTHER RECTORS OF
THE UNIVERSITY, BUT HE BROUGHT
WITH HIM ON THE LEFT THE TEAM OF
SCIENTISTS THAT I WAS REALLY
INTERESTED TO SEE SOME OF THOSE
PEOPLE I'VE KNOWN FOR OVER 15
YEARS, BACK IN THE DAYS WHEN
THEY WERE POSTDOCS, WE'VE
MAINTAINED RELATIONSHIP WITH
THEM.
ANOTHER IMPORTANT RELATIONSHIP
IS SHOWN ON LOWER RIGHT-HAND
CORNER, WHEN DR. GOGHALE, NEW
SECRETARY OF THE INDIA
DEPARTMENT OF BIOTECHNOLOGY, MET
WITH DR. FAUCI WITH THE JOINT
WORKING GROUP WHICH OVERSEES THE
SO-CALLED VACCINE ACTION PROGRAM
BETWEEN NIAID AND THE
BIOTECHNOLOGY DEPARTMENT IN
INDIA.
THIS RELATIONSHIP SPANS 35
YEARS, THE TWO OF THEM SIGNED
THE DOCUMENT THAT MAINTAINS THE
PROGRAM AS COLLABORATIONS
THROUGH 2027.
NOW WE'LL TURN TO EVERYBODY'S
FAVORITE TOPIC, THE BUDGET
UPDATE.
STATUTORY LAW SAYS THAT ON THE
FIRST MONDAY IN FEBRUARY, THE
PRESIDENT'S BUDGET IN THIS CASE
FOR 2024 WILL BE RELEASED.
I'VE SEEN THAT DATE SLIP MANY
TIMES AND I THINK WE'VE BEEN
TOLD THAT WILL HAPPEN AGAIN.
I DON'T KNOW WHAT IS IN THE
PRESIDENT'S 2024 BUDGET AND I'M
NOT ALLOWED TO TALK ABOUT IT IF
I DID.
SO LET'S TALK ABOUT FISCAL YEAR
2023.
THIS SLIDE SHOWS SOME KEY POINTS
OF THE OMNIBUS BILL ENACTED IN
DECEMBER OF 2023.
AND THERE ARE TWO OR THREE
THINGS I WANT TO DRAW YOUR
ATTENTION TO.
ONE IS THE 3.8% INCREASE FOR
NIAID COMPARED TO 2022.
AND I ONLY NOTE THAT BECAUSE
YOU'LL SEE IT'S LOWER THAN THE
AVERAGE INCREASE FOR OTHER NIH
INSTITUTES AND CENTERS, WHICH
I'VE NEVER SEEN BEFORE.
WE USUALLY RUN SLIGHTLY HIGHER.
AND I HAVE NO PARTICULAR
EXPLANATION FOR THAT.
I ALSO CALL YOUR ATTENTION TO
THIS 10.6% INCREASE FOR THE
OFFICE OF THE DIRECTOR.
PARTLY FOR CYBERSECURITY, AND
PARTLY TO EXPAND THE COMMON FUND
PROGRAM.
AND LASTLY, I WANT TO POINT OUT
TO YOU PANDEMIC PREPAREDNESS
DESPITE REQUESTS FOR FUNDS TO
MOUNT A PANDEMIC PREPAREDNESS
PROGRAM IN THE FUTURE, THERE WAS
NO ALLOCATION FOR THIS PURPOSE.
I MET WITH DR. FAUCI SHORTLY
BEFORE HIS DEPARTURE, AND WE
AGREED IT IS SIMPLY
UNCONSCIONABLE FOR NIAID TO NOT
HAVE PANDEMIC PREPAREDNESS
PROGRAM COMING OFF THE COVID
EXPERIENCE.
YOU'LL HERE THE DMID -- THE
SUBCOUNCIL WILL HEAR OUR PLANS
FOR A PROGRAM WHICH WE'LL HAVE
TO FUND OUT OF OUR OWN
ALLOCATION AT THIS POINT FOR
PANDEMIC PREPAREDNESS.
THIS IS A SLIDE YOU'VE SEEN
BEFORE WHICH SHOWS THE RELATIVE
SIZE OF THE INSTITUTES ACCORDING
TO THEIR BUDGETS, WE REMAIN
SLIGHTLY SMALLER THAN NCI.
IN MY TIME HERE THE TWO BALLOONS
THAT HAVE GROWN THE LARGEST HAVE
THE OFFICE OF THE DIRECTOR AND
THE NATIONAL INSTITUTE OF AGING,
RELATED TO INCREASED INTEREST IN
ALZHEIMER'S DISEASE AS PEOPLE MY
AGE GET OLDER.
THIS SLIDE SHOWS THE NIAID
FUNDING OVER THE ROUGHLY LAST 20
YEARS.
I ARRIVED ABOUT HERE,
IMMEDIATELY WE HAD ABOUT 8 YEARS
OF FLAT BUDGETS WHICH OF COURSE
DIDN'T KEEP UP WITH INFLATION SO
OUR ACTUAL SPENDING POWER WAS
DECREASED DRAMATICALLY DURING
THIS PERIOD OF TIME.
FOR THE PAST 8 YEARS OR SO, THE
FUNDING INCREASES HAVE BEEN MUCH
BETTER.
BEATING INFLATION SOME YEARS,
MATCHING IT IN OTHERS.
BUT NOT BY ANY MEANS MAKING UP
TO THE LEVEL OF BUYING POWER WE
HAD 20 YEARS AGO.
AS A RESULT OF OUR BUDGET
ALLOCATION, WE HAVE OUR
FINANCIAL MANAGEMENT PLAN.
YOU'VE SEEN THIS SLIDE BEFORE IN
PREVIOUS YEARS.
RIGHT NOW WE'RE WORKING ON THE
11th PERCENTILE INTERIM PAY
LINE, ENTER HIM PAYLINE I HOPE
VERY MUCH IT'S GOING TO GET
SLIGHTLY HIGHER BUT WILL NOT GET
SUBSTANTIALLY HIGHER THIS YEAR.
WE ALWAYS FUND THE NEW P.I.s
AT HIGHER PERCENTILE.
WE START AT 4% DIFFERENTIAL, BUT
IN FACT WHAT WE SEEK IN THE END
IS EQUAL SUCCESS RATE FOR NEW
INVESTIGATORS COMPARED TO
ESTABLISHED.
WE NEVER HAVE ENGAGED IN
DOWNWARD NEGOTIATIONS CUTTING
NON-COMPETING AND COMPETING
GRANTS, AND WE DO EACH YEAR TRY
TO TRIM BACK COMPETING
INITIATIVES AS MUCH AS 20% IN
ORDER TO PRESERVE FUNDS FOR THE
PAYLINE.
ESTIMATED SUCCESS THIS YEAR WE
EXPECT TO BE IN THE RANGE OF 18
TO 22% WHICH IS CLOSE TO WHERE
IT HAS BEEN IN PREVIOUS YEARS.
YOU SHOULD UNDERSTAND THAT OUR
BUDGET COMES WITH SUBSTANTIAL
EARMARKS.
PARTICULARLY FOR ANTIMICROBIAL
RESISTANCE, UNIVERSAL INFLUENZA
VACCINE, AND SET ASIDE FOR
REGIONAL BIOCONTAINMENT
LABORATORIES.
THESE ARE ALL IMPORTANT
PRIORITIES FOR THE INSTITUTE,
NONETHELESS WHEN YOU HAVE ALMOST
$2 BILLION OF YOUR BUDGET SET
ASIDE FOR AIDS, AND ALMOST A
BILLION DOLLARS OF OTHER
EARMARKS THAT MEANS THE VERY
SUBSTANTIAL CLOSE TO 50% OF YOUR
OVERALL BUDGET IS ALREADY
ENCUMBERED LEAVING VERY REDUCED
FLEXIBILITY.
I JUST WANT TO MENTION THE FUNDS
WE'VE RECEIVED FOR COVID
PURPOSES DURING THE LAST SEVERAL
YEARS.
BACK IN MARCH OF 2022, WE GOT
TWO SUPPLEMENTS THAT CAME TO A
TOTAL OF ABOUT $1.5 BILLION TO
SPEND LARGELY RESEARCH INVOLVIG
VACCINES AND THERAPEUTICS AND
BASIC PATHOGENESIS.
THIS MONEY HAS ESSENTIALLY BEEN
EXPENDED, IT'S GOOD UNTIL 2024,
THERE'S $20 TO $30 MILLION NOT
EARMARKED AT THIS POINT.
WE ALSO RECEIVED FUNDS TO A
VARIETY OF MECHANISMS, OPERATION
WARP SPEED, AND MOST RECENTLY
CALLED H-CORE WHICH FUNNELS
MONEY FROM THE DEPARTMENT TO
BARDA AND OTHER AGENCIES
INCLUDING NIAID, IN TOTAL OF
THAT FUNDING OVER THE COURSE OF
THE PAST THREE YEARS NOW IS IN
THE RANGE OF $3.4 MILLION, AND
THAT MONEY HAS BEEN USED IN PART
TO FUND THE CLINICAL TRIALS THAT
LED TO APPROVAL OF OUR VACCINES
IN PART FUNDING SOME CENTERS TO
DEVELOP NEW THERAPEUTICS, IT'S
FUNDED STUDIES ON VARIANTS AND
THEIR SUSCEPTIBLITY TO VACCINES
AND BOOSTER SHOTS.
WE'RE STILL SHORT OF FUNDING FOR
THE ACTIVITIES THAT WE NEED TO
DO AS PART OF THE COVID
RESPONSE.
NOW LEGISLATIVE UPDATE.
THERE'S OF COURSE HEARINGS
AGAIN, THERE'S A HELP HEARING ON
SEPTEMBER 14 IN 2022, LARGELY ON
WHAT WE USED TO CALL MONKEYPOX
BUT NOW OFFICIALLY TERMED
Mpox, BUT THE CONVERSATION AND
QUESTIONS WENT BEYOND MONKEYPOX
INTO OTHER AREAS.
THE CONGRESSIONAL CAUCUS, HIV
CAUCUS ON WORLD AIDS DAY, HELD A
RECEPTION WITH SOME PARTNERS
THAT HONORED DR. FAUCI FOR HIS
LONG MANY CONTRIBUTIONS TO HIV.
MANY OTHER MEMBERS OF OUR STAFF
HAVE PARTICIPATED IN
CONGRESSIONAL BRIEFINGS WITH
STAFF IN CONGRESS, INCLUDING
THOSE HERE, ON A WHOLE VARIETY
OF SUBJECTS INCLUDING MONKEYPOX,
SUE DAN EBOLA VIRUS OUTBREAK,
PAXLOVID REBOUND, OTHER TOPICS.
I'M GOING TO RUN THROUGH THE
FOLLOWING SLIDES QUICKLY.
DEALING WITH CHANGES IN
LEADERSHIP IN THE 118th
CONGRESS.
CHUCK SCHUMER IS MAJORITY LEADER
IN THE SENATE, MITCH McCONNELL
AS THE MINORITY LEADER.
YOU KNOW KEVIN McCARTHY IS NOW
SPEAKER OF THE HOUSE, AND THAT
REPRESENTATIVE HAKEEM JEFFRIES
HAS BECOME THE MINORITY LEADER.
THE SENATE APPROPRIATIONS
COMMITTEE IS NOW CHAIRED BY
PATTY MURRAY WITH RANKING MEMBER
BEING SUSAN COLLINS FROM MAINE.
THE HHS EDUCATION APPROPRIATIONS
SUBCOMMITTEE, THE CHAIR AND
RANKING MEMBER YET TO BE
DETERMINED.
THE SENATE HEALTH EDUCATION
LABOR AND PENSIONS COMMITTEE IS
NOW CHAIRED BY SENATOR BERNIE
SANDERS, I MET WITH HIM ALONG
WITH LARRY TABAK JUST YESTERDAY.
RANKING MEMBER SENATOR BILL
CASSIDY IS THE RANKING MEMBER.
HOMELAND SECURITY AND GOVERNMENT
AFFAIRS COMMITTEE IS CHAIRED BY
SENATOR GARY PETERS, RANKING
MEMBER SENATOR RAND PAUL.
HOUSE APPROPRIATIONS COMMITTEE
NOW CHAIRED BY KAY GRANGER,
RANKING MEMBER IS ROSA DELAURO,
AND HHS APPROPRIATION
SUBCOMMITTEE IS CHAIRED BY
REPRESENTATIVE ROBERT ADERHOLD,
RANKING MEMBER ROSA DELAURO.
HOUSE ENERGY AND COMMERCE
COMMITTEE CHAIR CATHY McMORRIS
RODGERS, RANKING MEMBER
REPRESENTATIVE FRANK PALLONE,
HEALTH SUBCOMMITTEE
REPRESENTATIVE BRETT GUTHRIE,
RANKING MEMBER ANNA ESHOO.
OVERSIGHT AND INVESTIGATES
COMMITTEE CHAIR REPRESENTATIVE
MORGAN GRIFFITH, RANKING MAYBE
TO BE DETERMINED.
I THINK THIS IS THE LAST OF THEM
IS THE HOUSE OVERSIGHT AND
ACCOUNTABILITY COMMITTEE, CHAIR
BEING REPRESENTATIVE JAMES
COMER, RANKING MEMBER
REPRESENTATIVE JAMIE RASKIN AND
SELECT COMMITTEE ON CORONAVIRUS
PANDEMIC, CHAIRED BRAD WENSTRUP,
RANKING MEMBER TO BE DETERMINED.
WE'LL BE WATCHING THIS CLOSELY.
WE'RE GOING TO MOVE TO COMMENTS
ON SOME KEY SCIENTIFIC AREAS OF
THE PAST FOUR MONTHS.
GREG ORIGINALLY GAVE ME ON THE
ORDER OF 50 SLIDES, IN THE
INTEREST OF TIME WE CUT THAT
BACK TOUCHING ON MAJOR
HIGHLIGHTS IN THE PAST YEAR.
THIS IS A LIST OF SOME DISEASES
THAT HAD OUTBREAKS DURING 2022,
EITHER IN THE UNITED STATES OR
MANY COUNTRIES OR OUTSIDE OF THE
UNITED STATES, AND YOU'RE
FAMILIAR WITH THE FREQUENCY OF
THESE OUTBREAKS.
LET ME BRIEFLY SUMMARIZE 3+
YEARS OF RESEARCH ON COVID-19, A
SLIDE OF THE NUMBER OF NEW CASES
WHICH NOBODY TAKES QUITE
SERIOUSLY AT THIS POINT BECAUSE
SO MANY OF THE CASES ARE
DIAGNOSED AT HOME AND NEVER
REPORTED.
MUCH MORE IMPORTANT IS THE
HOSPITALIZATIONS WHICH WE
BELIEVE IS MUCH MORE ACCURATE
NUMBER.
WHEN I TOOK OVER AS ACTING
DIRECTOR HERE, ON JANUARY 1, MY
NIGHTMARE FOR SEVERAL WEEKS WAS
THAT THIS CURVE WOULD BE HERE AS
OF COUNCIL.
AS YOU CAN SEE, THAT HAS NOT
TURNED OUT TO BE THE CASE, AND
THE NUMBERS OF HOSPITALIZATIONS
HAVE BEEN FALLING OVER THE LAST
SEVERAL WEEKS.
IT HAS ENABLED ME TO FINALLY
BEGIN TO EXHALE AGAIN AS IT
SEEMS THAT DESPITE THE FACT THE
COUNTRY HAS LARGELY OPENED TO
BUSINESS, ORDINARY KIND OF WAYS,
WE'RE
WE'RE NOT HAVING THE KIND OF
RESURGENCE WE FEARED MIGHT
OCCUR.
YOU DO KNOW XBB.1.5 IS THE MOST
RECENT VARIANT NOW OVER 50% OF
CASES IN THIS COUNTRY.
BUT, AGAIN, WITHOUT
HOSPITALIZATIONS INCREASING THIS
IS NOT PROVING TO BE A MAJOR
CONCERN AT THIS POINT.
YOU'RE AWARE THERAPEUTICS HAVE
BEEN DEVELOPED OVER THE COURSE
OF THE YEARS, PARTICULARLY
PAXLOVID, REMDESIVIR AND MAL
KNOW PEER VEER, AND WE'VE BEEN
INVOLVED IN STUDIES OF IMMUNE
MODULATORS, HEPARIN FOR
HOSPITALIZED PATIENTS.
THAT LEADS ME TO MENTION THE NIH
COVID-19 TREATMENT GUIDELINES,
PANEL TO DEVELOP TREATMENT
GUIDELINES WAS ORGANIZED ALMOST
IMMEDIATELY MARCH 24, 2020,
UNDER CO-DIRECTION OF CLIFF
LANE, UPDATED 62 TIMES,
ESSENTIALLY IN REAL TIME WITH AS
MANY AS 45 MILLION PAGE VIEWS.
YOU KNOW THERE ARE NOW FOUR
VACCINES AVAILABLE IN THE UNITED
STATES, TWO mRNA VACCINES, ONE
FROM PFIZER BioNTech, THE
OVER FROM MODERNA.
NOVAVAX HAS A PROTEIN SUBUNIT
VACCINE, J&J JANSSEN HAS A VIRAL
VECTOR VACCINE THAT CAN BE GIVEN
IN SOME SITUATIONS.
YOU KNOW CDC RECOMMENDED WE
CHANGE TO A BOOSTER THAT'S A
BIVALENT BOOSTER INCLUDING THE
ORIGINAL WUHAN STRAIN BUT
INCLUDING HALF THE VACCINE BEING
THE MOST RECENT OMICRON VARIANTS
PRIOR TO XBB.1.5.
IF YOU DON'T THINK VACCINATION
MATTERS OR BOOSTERS MATTER, LOOK
AT THIS AGE ADJUSTED RATE FOR
COVID-19 HOSPITALIZATION.
UNVACCINATED, VACCINATED WITH NO
BOOSTER, UPDATED BOOSTER WITH
THE BIVALENT, AND THOSE ARE THE
DIFFERENT IN HOSPITALIZATIONS
RATES.
IF YOU DON'T THINK VACCINATION
MATTERS, LOOK AT THIS SLIDE.
THERE HAVE BEEN THREE OUTBREAKS
IN THREE YEARS, SARS, MERS,
COVID-19.
WE'VE ALSO SEEN THE RAPID
DEVELOPMENT OF VARIANTS OF
CONCERN OVER THE PAST THREE
YEARS, SO CLEARLY THERE NEED TO
BE INNOVATIVE APPROACHES TO
INDUCE BROAD DURABLE PROTECTION
AGAINST CORONAVIRUSES.
NOT ONLY THOSE WE KNOW BUT THOSE
WE DON'T KNOW YET.
WHICH LEADS TO OUR EFFORT TO
DEVELOP NEXT GENERATION
VACCINES.
OUR FIRST MAIN EFFORT IS TO
DEVELOP A PAN CORONAVIRUS
VACCINE.
AND IN 2021, WE ACTUALLY WENT
AHEAD AND AWARDED SEVEN AWARDS
TO CENTERS TO DEVELOP A
PAN-CORONAVIRUS VACCINE, AT
LEAST ONE CENTER WE EXPECT TO
BEGIN CLINICAL TRIALS IN THE
VERY NEAR FUTURE.
THE OTHER AREA OF THERE IS
MUCOSAL VACCINE WITH AIM OF
PREVENTING INFECTION, NOT JUST
SEVERE DISEASE SO WE CAN BLOCK
TRANSMISSION OF THE VIRUS THAT
SEEMS SO TRANSMISSIBLE.
THIS IS NOT NECESSARILY GOING TO
BE AS EASY TO PURSUE AS SOME
PEOPLE THINK.
THERE ARE TWO RECENT ARTICLES ON
THE SUBJECT OF RETHINKING NEXT
GENERATION VACCINES IN
PARTICULAR MUCOSAL VACCINES ONE
BY DR. MORENS, HIGHLIGHTING
DIFFICULTIES IN PRODUCING A
TRANSMISSION-BLOCKING MUCOSAL
VACCINE.
WE DID ORGANIZE BACK IN 2022,
NOVEMBER, A WORKSHOP ON THE
DEVELOPMENT OF MUCOSAL VACCINES,
WE DID THIS AFTER THINKING OF --
PROCEEDING WITH IT, WE JOINED BY
PARTNERS BARDA, CEPI, BILL AND
MELINDA GATES FOUNDATION AND
WELLCOME TRUST, ALL THE ISSUES
WITH MUCOSAL VACCINES WERE AIRED
AND CONSIDERED.
THE LATE DRAFT IS CIRCULATING AT
THIS MOMENT AND I HOPE IT WILL
BE PUBLISHED IN THE NEAR FOR --
NEAR FUTURE.
THERE ARE CANDIDATE MUCOSAL
VACCINES MOVING TO CLINICAL
TRIALS, ALL SUPPORTED IN PART BY
NIAID, THIS ONE FROM ST. LOUIS,
THIS ONE FROM OUR OWN INTRAMURAL
PROGRAM.
BUT WE HAVE WORKED HARD TO
STRESS TO THE FUNDING AGENCIES
DOWNTOWN THAT THIS IS NOT GOING
TO BE A REPEAT OF OPERATION WARP
SPEED WHERE WE HAVE SUCCESS IN
LESS THAN ONE-YEAR TIME.
THIS IS A LONGER--TERM EFFORT
WE'RE UNDERTAKING.
LET ME TOUCH BRIEFLY ON HIV/AIDS
AS WE ALWAYS DO.
THIS REMAINS A TERRIBLE PROBLEM
WORLDWIDE, WITH 38 MILLION
PEOPLE LIVING WITH HIV AT THIS
TIME.
MAJOR NEWS IN THIS AREA
UNFORTUNATELY IS THE FAILURE OF
THE PHASE 3 SO CALLED MOSAIC
TRIAL OF HIV VACCINE REGIMEN IN
4,000 MEN IN EUROPE, NORTH
AMERICA, SOUTH AFRICA.
EVEN MORE DISAPPOINTING THAN THE
FAILURE AND COMPLETE FAILURE OF
THIS VACCINE WAS THE FACT THAT
BOTH TREATMENT ARMS AND PLACEBO
ARM HAVE INCIDENCE OF HIV OF 4%,
DESPITE THE FACT THAT PrEP WAS
OFFERED TO ALL OF THE
PARTICIPANTS IN THIS TRIAL.
WE THINK WE KNOW HOW TO PREVENT
HIV INFECTION BUT WE CERTAINLY
DON'T KNOW HOW TO PREVENT IT IN
THE REAL WORLD.
LET'S TALK BRIEFLY ABOUT THE
GLOBAL BURDEN OF MALARIA WHICH
CONTINUES TO BE A MAJOR PROBLEM
FOR CHILDREN, PARTICULARLY THOSE
UNDER 5 YEARS OF AGE, WITH
SUBSTANTIAL NUMBER OF WORLDWIDE
DEATHS.
WE'RE VERY PROUD OF THE
ANNOUNCEMENT OF SAFETY AND
EFFICACY OF A MONOCLONAL
ANTIBODY DEVELOPED IN PART IN
OUR INTRAMURAL PART BY BOB CDER
AND BILL COMPTON IN PROTECTING
HEALTHY NON-PREGNANT ADULTS
DURING AN INTENTION SIX MONTHS,
EFFICACY WAS 88% OVER A 24-WEEK
PERIOD.
TRIALS IN CHILDREN AND OTHER
PARTS OF AFRICA WITH BEING
INITIATED, I THINK YOU'LL HEAR
MORE ABOUT THE MONOCLONAL
ANTIBODIES TO PREVENT MALARIA
INFECTION IN THE COMING YEARS.
THEN OF COURSE THERE IS EBOLA,
OVER THE YEARS AS YOU KNOW THERE
HAVE BEEN OUTBREAKS OF ZAIRE,
SUDAN AND MARBURG CLOSELY
RELATED VIRUS, THIS YEAR
ATTENTION ON THE DEMOCRATIC
REPUBLIC OF CONGO WITH OUTBREAK
OF ZAIRE EBOLA VIRUS.
THE GOOD NEWS RECENTLY UGANDA
WAS ABLE TO DECLARE THE END OF
THIS EBOLA DISEASE OUTBREAK.
LET ME JUST BRIEFLY SAY THAT
THIS IS ONE EXAMPLE OF A TRIAL
UNDERWAY, TESTING IN THIS CASE
OF MARBURG VACCINE, SHOWING
PROMISE IN THE CLINICAL TRIAL
BUT IN FACT NIH NIAID SCIENTISTS
ARE WORKING ON ADDITIONAL ZAIRE
EBOLA VACCINES, SUDAN EBOLA
VACCINES, AS WELL AS MARBURG
VACCINES.
AGAIN TO MENTION UNIVERSAL FLU
AS A HIGH PRIORITY FOR THE
INSTITUTE, THIS IS ONE EXAMPLE
RECENTLY IN NOVEMBER OF A
PUBLICATION OF A PROMISING
mRNA VACCINE AGAINST ALL THE
KNOWN INFLUENZA VIRUS SUBTYPES,
WE HAVE MULTIPLE CANDIDATES IN
OUR INTRAMURAL PROGRAM FOR THE
UNIVERSAL FLU VACCINES, YOU WILL
SEE MANY CLINICAL PROGRAMS TO
TEST THESE VACCINES OVER THE
NEXT SEVERAL YEARS.
LET ME TURN A LITTLE BIT TO
IMMUNOLOGY.
THIS IS A STUDY PUBLISHED IN
"THE LANCET" THAT WAS THE FIRST
TO DEMONSTRATE AIR CONTAMINANTS,
OZONE AND FINE PARTICULATES,
INDEPENDENT OF ALLERGEN AND
RESPIRATORY VIRAL EXPOSURES CAN
TRIGGER ASTHMA EXACERBATIONS IN
CHILDREN, A STUDY FROM JEFF
COHEN'S GROUP, MONOCLONAL
ANTIBODIES PROVIDING PROTECTION
AGAINST EBV, WE'LL HEAR MORE IN
COMING YEARS, AND SYSTEMS
BIOLOGY APPROACH TO DETERMINING
DETERMINANTS OF IMMUNE RESPONSES
TO VACCINES, NOT A VACCINE BUT
VACCINES IN GENERAL, THIS WAS A
PROGRAM THAT STUDIED RESPONSE TO
13 VACCINES IN THE HUMAN
IMMUNOLOGY PROJECT CONSORTIUM,
HIPC, FUNDED BY IMMUNOLOGY,
ALLERGY AND TRANSPLANTATION,
IDENTIFYING A PATTERN OF
TRANSCRIPTIONAL RESPONSE THAT
CHARACTERIZES THOSE WHO RESPOND
WELL TO VACCINATION.
LET ME STOP THERE AND OPEN THIS
FOR QUESTIONS.
I APPRECIATE YOUR ATTENTION.
I'M HERE TO TAKE QUESTIONS LIVE.
THERE WERE TWO OR THREE PLACES I
CRINGED AS A MISSTATEMENT BUT
YOU PROBABLY PICKED UP THE
ERRORS IN THE PRE-RECORDED
REMARKS.
IF YOU HAVE QUESTIONS, SING OUT.
I DON'T SEE YOU ALL AND I WOULD
BE HAPPY TO TAKE QUESTIONS FROM
MANY OF YOU.
MONICA, HI.
>>THANK YOU SO MUCH.
THAT WAS GREAT.
DESPITE THE CONGRESSIONAL
MISUNDERSTANDING WHY WE SHOULD
FUND PANDEMIC PREPAREDNESS
INITIATIVE HOPEFULLY WE CAN
CONVINCE THEM HOW IMPORTANT IT
IS.
ONE QUESTION IS, MOSAICO TRIALS
WERE DISAPPOINTED BUT NOT
UNEXPECTS, THE VACCINES ARE
EXCITING, WONDERING -- THOSE ARE
NIH FUNDED, SMALL CLINICAL
TRIALS IN HUMANS, WONDERING IF
THERE WILL BE INTERIM RESULTS
PUT OUT ABOUT THOSE.
NUMBER TWO, I WANT TO ASK ABOUT
COVID VACCINES, SPECIFICALLY THE
INDIAN COMPANY THAT DOES HAVE A
MUCOSAL VACCINE WHICH IT'S VERY
UNCLEAR TO ME SORT OF THE
POST-MARKETING SURVEILLANCE AND
WHAT'S GOING TO HAPPEN WITH THAT
BUT THEY DID PUT THAT OUT.
AND WONDERING IF THE NIH HAS
EVALUATED THAT PRODUCT AND THE
SAME WITH THEIR WHOLE VIRUS
VACCINE WHICH IS THE COVAX
VACCINE WHICH IS DEVELOPED WITH
ADJUVANT FUNDED BY THE NIH, LIKE
THE ADJUVANT WAS FROM THE NIH,
THOSE TWO QUESTIONS ON VACCINES,
HIV AND COVID.
>>CARL, ARE YOU ON?
>>I'LL ANSWER THE FIRST
QUESTION.
YES, MONICA, WE'RE CONDUCTING
STUDIES OF DIFFERENT IMMUNOGENS
USING THE MESSENGER RNA
PLATFORM, EVALUATING SAFETY BUT
ALSO ARE USING SOME NOVEL ASSAYS
TO EXAMINE WHERE THE ANTIBODIES
THAT GET INDUCED IN PEOPLE BIND
TO THE HIV ENVELOPE.
SO THOSE WILL BE DEVELOPED AND
RELEASED.
THE INTENT FOR US IS TO REALLY
MOVE INTO A SET OF EXPERIMENTAL
MEDICINE TRIALS TO RAPIDLY
EVALUATE AND ITERATE OUR
IMMUNOGEN DESIGN SO WE CAN
ACCELERATE THE PROCESS OF
DISCOVERY.
>>OKAY.
THANK YOU.
>>ON THE ISSUE OF THE MUCOSAL
VACCINES, THE INDIANS ARE MOVING
AHEAD I BELIEVE WITH THE MICHAEL
DIAMOND PRODUCT.
I'VE SEEN ANIMAL DATA WITH THAT
PRODUCT BUT I'VE NOT SEEN HUMAN
DATA.
EMILY, DO YOU WANT TO MAKE
COMMENTS?
>>I'M HERE.
WE DID SUPPORT THROUGH MICHAEL
DIAMOND'S GRANTS THE DEVELOPMENT
OF A PRODUCT THAT'S NOW IN
ADVANCED CLINICAL DEVELOPMENT IN
INDIA WHICH I'M GUESSING THAT'S
WHAT YOU'RE TALKING ABOUT.
>>YEAH.
>>IT'S HARD TO KEEP TRACK.
>>YEAH.
THEY ARE ALREADY ROLLING IT OUT
SO I'M CURIOUS IF YOU HELPED
SUPPORT IT, WHAT KIND OF
EVALUATION ARE YOU GOING TO
REQUIRE FOR PHASE 4.
>>YEAH, WE CAN'T REQUIRE
ANYTHING.
IT'S THE INDIAN GOVERNMENT THAT
SETS THE REGULATORY STANDARDS
FOR SAFETY DATA IN THEIR
COUNTRY.
BUT CERTAINLY WE'RE INTERESTED.
SO, YOU KNOW, MAYBE WE CAN
REPORT BACK ON ANY DATA THAT WE
HAVE ACCESS TO AT A SUBSEQUENT
COUNCIL MEETING SINCE I THINK
WHAT YOU'RE TALKING ABOUT IS OF
GREAT INTEREST TO EVERYBODY IN
THE U.S. GOVERNMENT.
AND IN THE ACADEMIC COMMUNITY.
>>THANK YOU.
>>OTHER QUESTIONS?
GO AHEAD.
>>YES, HI.
THANK YOU SO MUCH FOR A
WONDERFUL SUMMARY AND A LOT OF
EVOLVING CHANGES AROUND
LEADERSHIP CLEARLY THAT WE'LL
HAVE TO SEE WHAT HAPPENS.
I HAVE A QUESTION IN THAT
REGARD.
I THINK MAYBE TOO EARLY TO SAY
BUT IN THE SENSE OF THE
INVESTMENT IN THE CLINICAL
TRIALS NETWORKS, HBTN, ACTG AND
HPTN, DO YOU THINK THAT WILL
REMAIN PRESERVED OR IS THAT
SOMETHING THAT COULD BE
INFLUENCED BY THE NEW LEADERSHIP
AT THE LEVEL OF NIAID AND
PERHAPS IT'S PROVOCATIVE
QUESTION BUT ONE THAT CERTAINLY
THERE ARE RUMORS FLYING AND
WOULD BE INTERESTED IN YOUR
PERSPECTIVE, YOUR AND CARL'S.
>>I CAN'T SPEAK FOR THE FUTURE
DIRECTOR NOT KNOWING WHO THAT
PERSON IS BUT CAN ASSURE YOU
WHILE I'M HERE THE AIDS CLINICAL
TRIAL NETWORKS WILL REMAIN VERY
MUCH INTACT.
AS YOU KNOW PROBABLY THEY ARE
VITALLY IMPORTANT IN THE COVID
RESPONSE.
HAVING A WARM READY-TO-GO
CLINICAL TRIALS NETWORK TURNED
OUT TO BE ENORMOUSLY IMPORTANT.
CARL, OVER TO YOU.
>>I AGREE WITH THAT.
I MEAN, THE ISSUE IS WE
RESPONDED BOTH ON THE
THERAPEUTIC SIDE AND THE VACCINE
AND MONOCLONAL ANTIBODY SIDE.
WE ARE NOT FINISHED WITH HIV.
THERE'S A LOT WE STILL HAVE TO
DO.
YOU DON'T TAKE A SET OF GRANTS
THAT ARE HALFWAY THROUGH THEIR
7-YEAR CYCLE AND START
DISMANTLING THEM.
WHAT WE CAN DO I THINK IS HAVE A
PRINCIPAL DISCUSSION CLOSER TO
RENEWAL ABOUT SIZE, SHAPE, AND
DIRECTION.
WE DO THAT EVERY SEVEN YEARS, AS
YOU'RE AWARE, LAST TIME WE
STARTED TWO YEARS BEFORE THE
RECOMPETITION.
WE WORE EVERYBODY OUT TALKING
ABOUT POTENTIAL CHANGES AND
INTEND TO DO SOMETHING SIMILAR
AGAIN.
>>THANK YOU.
ONE OTHER QUESTION IF THAT'S
ALLOWED.
>>YES.
>>INTERESTED TO FOLLOW UP ON
MONICA GANDHI'S QUESTION ABOUT
PANDEMIC PREPAREDNESS, HAS THERE
BEEN DISCUSSION AROUND SORT OF
COLLABORATING WITH OTHER FEDERAL
AGENCIES TO SORT OF GO IN
TOGETHER TO LOBBY OUR CONGRESS
AND THOSE WHO ARE EMPOWERED TO
REALLY MAKE THESE DECISIONS,
GIVEN -- I MEAN IT'S JUST A
COMPLETE NO BRAINER, OBVIOUSLY
TO PEOPLE LIKE US, BUT SEEMS
RATHER SHOCKING THERE ISN'T AN
ALLOCATION, JUST INTERESTED IN
WHAT IS HAPPENING AT THE LEVEL
OF, YOU KNOW, CONSTITUENCIES AND
SORT OF MAKING PRESSURED -- NOT
PRESSURED BUT INFORMED ADVOCACY
ON THIS FRONT.
>>AGAIN, I'LL TURN IT OVER TO
EMILY.
BUT YES, WE'VE BEEN IN CONSTANT
CONVERSATION WITH OUR VARIOUS
COLLEAGUES AROUND THE FEDERAL
GOVERNMENT.
IT REALLY IS KIND OF STAGGERING
THAT THREE YEARS INTO THE
COVID-19 EXPERIENCE, WE'RE NOT
IN FACT FUNDING A MAJOR PANDEMIC
PREPAREDNESS PROGRAM.
EMILY?
>>SO YOU'RE ASKING ABOUT OUR
EFFORTS OVERALL, AMITA?
>>THERE'S NO CONGRESSIONAL LINE
ITEM SUFFICIENT, BASICALLY THE
BLANK LINE THERE WHICH IS RATHER
SHOCKING, SO THINKING WHAT MORE
CAN WE DO, WHAT MORE CAN BE
DONE, THIS IS SOMETHING THAT
ABSOLUTELY NEEDS TO BE FIXED.
>>YEAH, SO AS EMPLOYEES OF THE
EXECUTIVE BRANCH WE CAN'T LOBBY
CONGRESS, IN OUR BRIEFINGS WITH
CONGRESS.
WHAT WE HAVE PUT MONEY INTO, AND
THIS CAME THROUGH I THINK IN
THAT $3.3 BILLION FIGURE THAT
YOU SAW ON A SLIDE SLIDE, WE DD
THE DRUG DEVELOPMENT CENTERS
FOCUSING ON CORONAVIRUS AND ONE
OTHER MRNA VIRUS, THEY ALL
HAVE LINKS TO INDUSTRY WHICH WE
HOPE WILL AID IN THEIR LATE
DEVELOPMENT PATHWAY
SUCCESSFULLY.
THOSE WERE FUNDED -- GOT THREE
YEARS OF FUNDING IN ONE GIANT
LUMP, THERE'S NINE OF THEM,
WE'RE HOPEFUL IN SOME WAY, SHAPE
OR FORM, THIS WOULD BE IN FISCAL
YEAR, AFTER FISCAL YEAR 25, WE
CAN CONTINUE TO FUND THEM FOR
THE FIVE-YEAR PROJECTS THAT THEY
APPLIED FOR.
SO, THAT'S A BIG PROJECT FOR
ANTI-VIRAL DRUG DISCOVERY WHICH
WE THOUGHT WAS A HUGE GAP IN
PANDEMIC PREPAREDNESS.
THIS AFTERNOON IN THE DMID OPEN
SESSION OF SUBCOUNCIL, SORRY YOU
WON'T BE THERE AMITA BUT YOU CAN
WATCH ONLINE LATER, WE'LL BE
PROPOSING TO OUR SUBCOUNCIL THE
REVAMP INITIATIVE WHICH WILL
SORT OF DO THE SAME IN PANDEMIC
PREPAREDNESS FOR VIRAL FAMILIES
OF PANDEMIC CONCERN, FOCUS ON
VACCINES, AND MONOCLONAL
ANTIBODIES FOR PROTOTYPE
FAMILIES OF VIRUSES, A PROTOTYPE
VIRUS WITHIN A FAMILY THAT MIGHT
BE A FAMILY OF PANDEMIC CONCERN.
SO WE'RE DOING EVERYTHING WE CAN
TO MOVE THIS FIELD FORWARD WITH
THE RESOURCES THAT HAVE BEEN
ALLOCATED TO US IN THE FEDERAL
GOVERNMENT.
>>THANK YOU.
>>THAT'S ALL I CAN SAY.
>>OKAY.
SEEING NO ADDITIONAL QUESTIONS
I'M GOING TO --
>>JUST ONE MORE QUESTION.
MY UNDERSTANDING, BECAUSE WE'VE
BEEN THINKING ABOUT THIS A LOT
WITH THE PEPFAR 20-YEAR
ANNIVERSARY ON SATURDAY, THE
40th ANNIVERSARY OF SO MANY
PROGRAMS, IS THAT ONE THING I'M
SEEING IS THAT BIPARTISAN
SUPPORT FOR HIV HAS NOT DIMMED.
I MEAN, IS THAT YOUR IMPRESSION
AS LEADERS AT NIAID THAT, YES,
THERE'S THIS POLITICIZATION OF
VIRUSES LIKE COVID BUT HIV A
COMMITMENT WITH THE SETBACKS
DURING THE COVID PANDEMIC,
FUNDING THAT AT NIAID LEVEL, AND
WHEN YOU -- I KNOW YOU CANNOT
BREAK IT DOWN TO EXACTLY HOW
MUCH HIV BUT ISN'T THAT ACCURATE
WE CAN BREATHE A SIGH OF RELIEF
THERE'S BIPARTISAN SUPPORT
ONGOING FOR HIV?
>>CARL?
DID WE LOSE CARL?
THE SIMPLE ANSWER IS YES,
SUPPORT IS THERE.
CARL, DO YOU WANT TO MAKE
FURTHER COMMENTS?
>>I DIDN'T HEAR THE QUESTION.
>>IS THERE STILL BIPARTISAN
SUPPORT FOR HIV?
>>YES, THERE IS.
CLEARLY WE GOT AN INCREASE THIS
YEAR.
>>YEAH, OKAY.
>>OKAY.
NEXT WE'RE GOING TO TURN TO
RENEE WEGRYZN, WITH AN OVERVIEW
OF THE NEW ARPA-H.
>>THANK YOU FOR INSTREETING ME
TO -- FOR INVITING ME.
I HAVE A FEW SLIDES TO TELL YOU
ABOUT ARPA-H'S MISSION, AND
WHERE WE'RE AT TODAY.
WE'LL HAVE TIME FOR Q&A AT THE
END IF I UNDERSTAND CORRECTLY.
BEFORE I JUMP IN THOUGH FOR THIS
GROUP IN PARTICULAR I'D LIKE TO
SHARE A LITTLE BIT OF MY
BACKGROUND IN TERMS OF HOW IT
TOUCHES ON INFECTIOUS DISEASE
WHEN I WAS A PROGRAM MANAGER AT
DARPA LAUNCHED FOUR PROGRAMS,
TWO DIRECTLY RELATED TO
INFECTIOUS DISEASE, ONE WAS
CALLED THE PREPARE PROGRAM WHERE
WE DEVELOPED NOVEL TYPES OF
ANTI-VIRALS, USED mRNA,
[AUDIO DISTORTION]
WE COULD HAVE BROAD SPECTRUM FLU
AND ULTIMATELY COVID, SARS-COV-2
ANTI-VIRALS THAT TARGETED NOT
THE SHAPE-SHIFTING SPIKE PROTEIN
SEQUENCES BUT RATHER THE GENOMIC
SEQUENCES THAT WERE HIGHLY
CONSERVED AMONG THE VIRUSES SO
THIS ALLOWED US TO HAVE PAN
VIRAL EFFICACY AND I HOPE THAT
GIVES YOU THE FLAVOR OF WHAT AN
ARPA-TYPE APPROACH TO INFECTIOUS
DISEASE AND MEDICAL SCIENCE
MIGHT LOOK LIKE.
NOT READY FOR THIS PANDEMIC BUT
CERTAINLY FOR FUTURE PANDEMICS
WE'RE HERE TO BE A CATALYST FOR
SOME OF THAT DEVELOPMENT.
AFTER DARPA I WENT OUT TO
INDUSTRY AND WAS AT GINGKO
BIOWORKS, WE ACTUALLY LAUNCHED A
NATIONWIDE COVID TESTING
PROGRAM, NON-TRADITIONAL
SETTINGS, K-12 SCHOOLS AND
AIRPORTS, SO WE ARGUED THAT THE
NEXT PANDEMIC WHETHER IT'S A NEW
VARIANT OF COVID OR FLU OR
WHATEVER THAT MIGHT BE WOULD BE
INTRODUCED THROUGH AN AIRPORT
AND TRAVEL, AND DETECTED EARLY,
SENTINEL POPULATION LIKE K-12.
AT THE CDC WEBSITE YOU CAN SEE A
DASHBOARD FOR GENOMIC
SURVEILLANCE THAT WAS ACTUALLY
BUILT FROM THE TEAM THAT I WAS A
PART OF WHEN I WAS AT GINGKO
BIOWORKS.
SO INFECTIOUS DISEASES IS NEAR
AND DEAR TO MY HEART, AND I WILL
SHARE ARPA-H, WE'RE NOT MANDATED
TO WORK ON ANY ONE DISEASE.
WE'RE DISEASE AGNOSTIC BUT
CERTAINLY THESE TYPES OF
CHALLENGES WOULD BE IN SCOPE FOR
US.
I'M GOING TO SHARE MY SCREEN
HERE, HOPEFULLY YOU CAN SEE
EVERYTHING CLEARLY.
OUR MISSION AT ARPA-H IS TO
ACCELERATE BETTER HEALTH
OUTCOMES FOR EVERYONE.
SUCCESS FOR US IS SOMETHING THAT
IS ADOPT AND USED BY A
COMMUNITY, IN THE WILD THE
AMERICAN PUBLIC HEALTH CARE
PROVIDERS, PATIENTS, EVERY
CITIZEN.
SO SINCE I WAS SWORN IN ON
OCTOBER 11 OF LAST YEAR, I'VE
BEEN HERE JUST OVER THREE
MONTHS, WE LANDED ON THIS
MISSION STATEMENT AS SOMETHING
THAT WILL STAND THE TEST OF TIME
IN ALIGNMENT WITH PRESIDENT
BIDEN'S VISION TO PURSUE IDEAS
TO BREAK THE MOLD HOW WE
APPROACH FUNDAMENTAL RESEARCH.
WE'RE NOT HERE TO REPLACE ANYONE
IN THE HEALTH CARE FUNDING
ECOSYSTEM BUT HERE TO AUGMENT,
CATALYZE, ACCELERATE BRINGING
SOME OF THOSE INNOVATIONS
FORWARD.
SO BASED ON THE PRESIDENT'S
VISION WE'RE TAKING THIS AS OUR
MOMENT, ERA OF COMPLEX
TECHNOLOGIES, THAT LEAD TO
DISRUPTIONS WHETHER ECONOMIC,
SOCIAL, PANDEMICS CAUSE
DISRUPTIONS BUT IN A CREDIBLE
TIME WHERE BIOTECHNOLOGIES AND
INNOVATION ARE REALLY ADVANCING
THE STATE OF THE ART, POWERFUL
BIOLOGY IN THE FORM OF PANDEMIC
CAN COMBATED BY POWERFUL BIOLOGY
IN THE FORM OF mRNA VACCINES
AS JUST ONE EXAMPLE.
THE WAY THAT WE WANT TO PURSUE
THIS VISION, OUR PROMISE IS TO
HIRE PROGRAM MANAGERS WHO ARE
GOING TO BUILD, CREATE, DESIGN
THE SOLUTIONS FOR THIS BETTER
HEALTH CARE FUTURE.
AND SO VERY UNIQUE IN TERMS OF
THE BUSINESS STRUCTURE, I WON'T
SET A TECHNICAL VISION OF THESE
ARE THE TEN PROGRAMS, FOR
EXAMPLE, THAT WE'LL FUND THIS
YEAR.
INSTEAD WE SEEK OUT THOSE
VISIONARIES WHO CAN COME JOIN
ARPA-H FOR A TERM APPOINTMENT SO
THE CONGRESS HAS ALLOWED US TO
HAVE A TERM APPOINTMENT BASE OF
THREE YEARS RENEWABLE FOR UP TO
ANOTHER THREE, SO THAT PROGRAM
MANAGER COMES IN, NOT ONLY WITH
A GREAT CV BUT SPECIFIC PROBLEM
IN HEALTH IN MIND THEY WANT TO
SOLVE.
I ANTICIPATE THAT THEY WILL
LAUNCH ABOUT A PROGRAM A YEAR
BEFORE THEY LEAVE THE
ORGANIZATION.
AND SO I'LL TALK A LITTLE BIT
MORE ABOUT THAT MODEL BUT I
THINK IT'S A REALLY IMPORTANT
PREMISE TO UNDERSTAND HOW IF YOU
LOOK AT ARPA-H THIS YEAR,
COMPARED TO FIVE YEARS FROM NOW,
IT'S GOING TO LOOK LIKE A
TOTALLY DIFFERENT AGENCY IN
TERMS OF PROJECTS WE'RE FUNDING
BECAUSE THEY ARE DRIVEN BY THOSE
PROGRAM MANAGERS.
WE WERE LOOKING FOR THOSE
VISIONARIES WHO WANT TO IMAGINE
A FUTURE WITH THERAPIES COULD BE
PROGRAMMED FOR EACH NEW DISEASE
TARGET, GREAT PROOFS OF CONCEPT
IN PARKINSON'S BUT DOSE IN SCALE
IS MISSING, MRIs REQUIRE A
CENTRAL SYSTEM TO DO THE MRI,
WHAT IF WE CAN DELIVER THIS IN
THE COMFORT OF SOMEBODY'S HOME?
MORE AND MORE HOSPITALS ARE
CLOSING, HOW DO WE BRING MORE
CARE TO THE HOME?
EXAMPLE OF THE PERSONALIZED
CANCER VACCINE, COSTING THE SAME
AS A CUP OF COFFEE, THESE ARE
AREN'T REALLY PROBLEMS AT
ARPA-H, WE'RE EXPECTING PROGRAM
MANAGERS THIS QUARTER TO REPLACE
STATEMENTS WITH ACTUAL PROGRAMS
WE'LL BE RUNNING BUT WANT TO
INSPIRE WHAT THOSE PROGRAMS
COULD LOOK LIKE.
ARPA-H IS AN ORGANIZATION WITHIN
BOTH HHS AND NIH.
IT'S AN INTERESTING STRUCTURE
THAT I THINK IS WORTH SPENDING A
MINUTE ON HOW THIS WORKS.
THE ARPA-H DIRECTOR, I REPORT TO
SECRETARY BECERRA, HE'S MY BOSS.
BUT WE'RE AN AGENCY WITHIN NIH.
SO WHAT THAT MEANS IS WE'RE VERY
LUCKY TO BE WORKING WITH SUBJECT
MATTER EXPERTS LIKE THE FOLKS AT
NIAID TO UNDERSTAND SOME OF THE
BIG PROBLEMS THAT WE COULD
PURSUE GOING FORWARD TO TAP INTO
THEIR NETWORKS TO LOOK FOR THOSE
PROGRAM MANAGERS THAT WE WANT TO
HIRE, AND AS WE LAUNCH PROGRAMS
TO WORK WITH THEM AS SUBJECT
MATTER EXPERTS TO HELP INFORM
AND GUIDE OUR PROGRAMS EVEN IF
WE SET THE MILESTONES AND
METRICS, WE DEFINITELY BENEFIT
FROM HAVING THAT SUBJECT MATTER
EXPERTISE CLOSE TO US.
SO, UNDER ARPA-H WE HAVE THE
PROGRAM MANAGERS AND THE
BUSINESS TEAM MEMBERS, I'M HAPPY
TO SAY WE'VE HIRED ABOUT 100
BUSINESS TEAM MEMBERS AND SO
THIS IS - IN A SHORT TIME WE'RE
TRYING TO CREATE THE SIDE OF THE
HOUSE AS I CALL IT TO BE ABLE TO
SUPPORT A PROGRAM MANAGER WHEN
THEY WALK IN THE DOOR.
SO THINK THE COMMUNICATIONS
TEAM, OUR CONTRACTING TEAM, OUR
HUMAN RESOURCES TEAM, EVERYBODY
THAT'S GOING TO NEED TO BE IN
PLACE WHEN THE PROGRAM MANAGER
ARRIVES TO LAUNCH THOSE PROGRAMS
AS QUICKLY AS POSSIBLE.
THE PRESIDENT STARTED OUT WITH
INITIAL BUDGET OF $1 BILLION TO
GET STARTED IN FISCAL YEAR 2023,
WE'VE RECEIVED ANOTHER
$1.5 BILLION TO GO AFTER THESE
BIG PROGRAMS.
WE ANTICIPATE THAT EACH PROGRAM
WILL RUN BETWEEN 50 AND $150
MILLION PER PROGRAM, WHICH IS
BASED ON AVERAGE EXPERIENCE FROM
PRIOR DARPA EXPERIENCE.
WE DON'T HAVE INTERNAL RESEARCH
LABS.
WE'RE EXCLUSIVELY EXTRAMURAL AND
DISEASE AGNOSTIC, AND PROGRAM
MANAGERS WILL DRIVE THE
DECISIONS BUT ALSO THE DECISION
MAKING.
SO WE'RE EXEMPT FROM SOME OF THE
NIH POLICIES INCLUDING NEEDING A
STUDY SECTION.
IN ORDER FOR US TO TAKE BIG
RISKS AND GO AFTER THOSE
CATALYTIC PROJECTS IN HEALTH
THAT ARE UNABLE TO BE FUNDED
ELSEWHERE IN THE FEDERAL
GOVERNMENT, WE CAN TAKE THOSE
RISKS BY HAVING AN INDIVIDUAL AS
A DECISION MAKER MOVING FORWARD
ON THOSE PROGRAMS.
AND SO WITH THIS MODEL WE INTEND
TO CREATE A FLYWHEEL OF PROGRAM
MANAGERS WHO COME INTO THE
AGENCY FOR 3 TO 6 YEARS, AND
PROGRAMS THEY ARE GOING TO
LAUNCH, ONE PER YEAR, THAT LAST
TWO TO FOUR YEARS AND THOSE
PROGRAMS ALSO LEAVE THE
ORGANIZATION, WE MUST TRANSITION
THEM TO FUNDERS AND ENTITIES
OUTSIDE OF ARPA-H.
SO LONG-TERM FUNDER MIGHT BE NIH
BUT WE COULD WORK TO SPIN OUT A
COMPANY AND IT BECOMES
COMMERCIALIZED, THE GOVERNMENT
CAN BECOME A CUSTOMER FOR THAT
SOLUTION LAUNCHED FROM ARPA-H.
A LITTLE BIT MORE ON THE MODEL.
AS I MENTIONED A PROGRAM MANAGER
COMES IN, NOT ONLY WITH THEIR
GREAT BACKGROUND BUT THE
CHALLENGE AND PROBLEM THEY WANT
TO SOLVE, THAT MAGIC
COMBINATION, THEY COME IN, IN
THREE TO FOUR MONTHS THEY WRITE
A SOLICITATION, CALL FOR
PROPOSALS, TALK TO EXPERTS,
MAKING SURE THEY ARE HITTING
THOSE VERY AMBITIOUS METRICS
THEY ARE GOING TO NEED, IF THEY
ARE GOING TO LAUNCH A PROGRAM.
THEY ARE GOING TO SELECT THE
TEAMS THEY FUND, PERFORMERS THEY
FUND UNDER THIS PROGRAM.
ARPA-H PROGRAMS, THE MODEL, IS
VERY INTENSIVE, WE CALL IT HIGH
CONTACT PROGRAM MANAGEMENT.
AND SO WHEN A P.M., PROGRAM
MANAGER, IS MANAGING A PROGRAM
THEY WILL BE ENGAGED WITH TEAMS
ON A MONTHLY, SOMETIMES EVEN
WEEKLY BASIS, TO MAKE SURE THEY
ARE MAKING PROGRESS AGAINST
THEIR GOALS.
THEY WILL NOT BE GRANTS.
THEY WILL BE COOPERATIVE
AGREEMENTS.
THEY WILL BE CONTRACTS.
THEY WILL BE VERY FOCUSED ON
ACHIEVING THAT SOLUTION.
ACTIVE PROGRAM MANAGEMENT ALSO
MEANS CUTTING FUNDING FOR A TEAM
IF THEY ARE NOT MEETING THOSE
METRICS AND GOALS, SO IT'S NOT
UNUSUAL TO SEE AT THE BEGINNING
OF A PROGRAM YOU MAY HAVE THREE
OR FIVE PERFORMERS THAT EACH
BRING A DIFFERENT APPROACH TO
SOLVING A BIG PROBLEM IN HEALTH,
AT THE END YOU MAY HAVE ONLY ONE
OR TWO TEAMS THAT ACTUALLY MAKE
IT TO THE END AND HAVE THEIR
CAPABILITY LAUNCHED.
BECAUSE OF THIS, SUCCESS TO
TRANSITION OUT OF THE AGENCY,
I'LL SHARE INFORMATION ABOUT A
WHOLE OFFICE WE'RE STANDING UP
AROUND TRANSITION.
WE HAVE TO HELP THESE PROGRAMS
START, EVERYTHING FROM EVEN
BEFORE PROGRAM LAUNCHES, MAKE
SURE WE UNDERSTAND REIMBURSEMENT
MODELS, MAKE SURE WE'VE DONE
MARKET ASSESSMENT.
WE CAN PURSUE A CONCEPT EVEN IF
THERE ISN'T A MARKET YET BUT
WANT TO UNDERSTAND THAT AND SAY
ARE WE GOING TO HAVE TO DEVELOP
THIS MARKET OVER THE COURSE OF
THE PROGRAM?
AGAIN, WE'RE PART OF THE ENTIRE
HEALTH ECOSYSTEM.
OUR CUSTOMERS ARE THE PUBLIC,
HEALTH CARE PROVIDERS, PATIENT
GROUPS, PERFORMERS WILL BE
ACADEMIA AND INDUSTRY,
STAKEHOLDERS OF COURSE INCLUDE
NIH, FDA, CMS, PARTS OF HHS,
MAKE STAKEHOLDERS, NGOs, AND
THOSE ACROSS THE HEALTHCARE
ECOSYSTEM.
IT'S HELPFUL TO TAKE A MOMENT TO
UNDERSTAND HOW WE FRAME THESE
WELL-DEFINED PROBLEMS IN HEALTH.
WE'VE ADOPTED AND MODIFIED WHAT
ARE CALLED HIGH HEILMEIER
QUESTIONS.
GEORGE HEILMEIER SAID EIGHT
QUESTIONS HOW YOU DEFINE, WHAT
IS THE PROBLEM YOU'RE TRYING TO
SOLVE, HOW DOES IT GET DONE,
WHAT'S NEW ABOUT YOUR APPROACH?
WHY ARE YOU EXCITED?
IS THERE INNOVATION NOW
PUBLISHED OR PATENTED THAT WE
CAN REALLY BE EXCITED ABOUT?
WHO CARES IF IT'S SUCCESSFUL,
WILL THIS MAKE A DIFFERENCE?
LET'S QUANTITATE THE IMPACT, IS
IT WORTH INVESTING IN?
WHAT ARE RISKS THAT CAN PREVENT
YOU FROM REACHING OBJECTIVES BUT
OF THE PROGRAM ITSELF?
IS THIS TECHNOLOGY -- YOU KNOW,
WE'VE HEARD THIS, THERE ARE
BIOTECHNOLOGIES YOU SHOULDN'T
JUST DO EVERYTHING, RIGHT?
HOW DO WE PUT THE GUARD RAILS ON
THINGS THAT COULD BE MISUSED?
HOW WILL IT TAKE, HOW MUCH WILL
IT COST?
WHAT ARE OUR MIDTERM AND FINAL
EXAMS FOR SUCCESS?
THE PROGRAM MANAGER WILL DO THAT
AS THEY MOVE FORWARD.
WE'VE ADDED TWO NEW QUESTIONS
FOR ARPA-H.
ONE IS WE WANT TO ENSURE
EQUITABLE ACCESS FOR ALL PEOPLE.
OUR MISSION IS TO ACCELERATE
BETTER HEALTH OUTCOMES, AND HOW
WILL WE ADDRESS COST, DESIGNING
TOOLS PEOPLE WANT TO ADOPT.
WE WANT FOMO AROUND OUR
PROGRAMS, I WANT THAT, ARPA-H IS
CATALYZING SOMETHING THAT'S
GOING TO MAKE AN IMPACT.
FINALLY NUMBER 10, HOW MIGHT
THIS PROGRAM BE MISPERCEIVED OR
MISUSED?
ALL OFS
ALL OF US IN THE FEDERAL
GOVERNMENT AND BEYOND ARE
DEALING WITH MISINFORMATION
SPECIALLY AROUND HEALTHCARE
TECHNOLOGY AND WANT TO
UNDERSTAND AND GET AHEAD AND
MAKE SURE WE'RE MAKING CLEAR
WHAT ARE TECHNOLOGIES WE'RE
ADDRESSING, EVEN WHEN TECHNOLOGY
IS READY TO GO LIVE MAKE SURE
WE'RE ADDRESSING THESE
COMMUNICATION CHALLENGES.
SO A TYPICAL PROGRAM LIFE CYCLE
FROM IDEAS TO SOLUTIONS IN THE
REAL WORLD COMES FROM DESIGNING
THOSE PROGRAMS.
THEY HAVE TO BE NON-REDUNDANT
WITH THE REST OF THE FEDERAL
GOVERNMENT, WITHIN THE HEILMEIER
FRAMEWORK, HIGH RISK AND HIGH
CONSEQUENCE.
NIH IS A STAKEHOLDER OF VENTURE
CAPITAL FIRM.
WE WANT THOSE INSIGHTS.
PMs WILL EXECUTE AND MEASURE
THROUGHOUT, WE CONSIDER THEM THE
CEO OF THE PROGRAM, MAKING SURE
THIS IS OPERATING.
THIS IS REALLY MOVING FORWARD,
THEY ARE SPENDING MONEY, A GOOD
STEWARD OF TAXPAYER DOLLARS.
IT'S A VERY ACTIVE ROLE DURING
THE LIFE CYCLE OF THE PROGRAM.
WITH THE GOAL OF ADVANCING THE
STATE OF THE ART, WELL BEYOND
100X, NOT EVOLUTIONARY OR
INCREMENTAL BUT REVOLUTIONARY
DISRUPTIVE CHANGES WE'RE LOOKING
FOR IN THESE PROGRAMS.
AND WE WANT TO DE-RISK THESE
INVESTMENTS THAT WE'VE MADE FOR
OTHERS THAT CAN FOLLOW ON BEHIND
US.
I THINK FOR THIS AUDIENCE IT'S
HELPFUL TO THINK HOW SHOULD
NIAID AND NIH THINK ABOUT
[AUDIO DISTORTION]
EARLY IN THE DESIGN TO HAVE
BETTER UNDERSTANDING OF THE
PROBLEM IN HEALTH.
[AUDIO DISTORTION]
WE WANT TO MAKE SURE THAT WE'RE
NOT THE
[AUDIO DISTORTION]
WE'RE BUILDING A PERFORMER TEAM.
COLLEAGUES AT NIH CAN SHARE
OPPORTUNITIES WITH COMMUNITIES
AND SUPPORT PROPOSAL EVALUATION
WHEN PROPOSALS COME IN.
ALL OF MY PROGRAMS WHEN I WAS AT
DARPA HAD NIH SUBJECT MATTER
EXPERTS PROVIDING SOME REVIEWS,
ULTIMATELY WAS THE SINGLE
DECISION MAKER BUT DID WANT TO
HEAR PERSPECTIVES FROM EXPERTS
ON, YOU KNOW, WHERE IS THE STATE
OF THE ART, WILL THIS MAKE AN
IMPACT, THIS IS A REALLY
IMPORTANT ASPECT OF THIS.
FOR THOSE PROGRAMS THAT ARE NEAR
AND DEAR TO AN NIH I.C. AND
BEYOND WE WANT TO HAVE THOSE NIH
PLAYERS AS STAKEHOLDERS TO SEE
WHAT THE PROGRESS IS, AND HELP
ADVANCE THEIR OWN PROGRAMS ALONG
THE WAY, ESPECIALLY IF THEY ARE
GOING TO BE OUR TRANSITION
PARTNERS.
SO WE NEED TO MAKE SURE WE'RE
SHAPING PROGRAMS THAT CAN
TRANSITION AND THAT WE'RE
DEVELOPING SO THEY CAN RECEIVE
THAT LONG-TERM MAINTENANCE
FUNDING ON THE BACK END.
I DID SAY THAT I'M NOT GOING TO
DICTATE WHAT PROGRAMS WE'RE
GOING TO FUND BUT IDENTIFIED
INITIAL FOCUS AREAS THAT HELP
GIVE AN IDEA OF THE TYPES OF BIG
LEVERS IN HEALTH WE SEE OUT
THERE WITH SIGNIFICANT
INVESTMENT WE REALLY WILL
ADVANCE THE STATE OF THE ART TO
IMPROVE BETTER HEALTH OUTCOMES
FOR EVERYONE.
ONE IS HEALTH SCIENCE FUTURES,
EXPANDING WHAT'S TECHNICALLY
POSSIBLE.
WHAT DISEASES?
WE'RE DISEASE AGNOSTIC AND WANT
TOOLS, PLATFORMS AND
TECHNOLOGIES RELEVANT FOR A
NUMBER OF DISEASES.
IF YOU CAN IMAGINE MAYBE DIGITAL
HISTOPATHOLOGY, A.I. MACHINE
READABLE DIAGNOSTIC TOOL WOULD
ADVANCE STATE OF THE ART FOR
CANCER AND ALZHEIMER'S DISEASE,
SO A PROGRAM MANAGER MAY FUND
PROJECTS AROUND BOTH.
I'M GOING TO TAKE A SIP OF WATER
REAL QUICK.
SCALABLE SOLUTIONS, THESE ARE
MAKING SURE THAT THERE HAS BEEN
INVESTMENT IN SOME PLACES, MAYBE
THERE'S A PROOF OF CONCEPT BUT
WE HAVEN'T MADE SOMETHING AT
SCALE.
BY SCALE I MEAN MANUFACTURING
SCALE, ALSO IN TERMS OF MEETING
PEOPLE IN THEIR HOMES.
THE CUSTOMER IS THE PERSON
PEOPLE AND HOW DO WE REACH
EVERYBODY?
PRO-ACTIVE HEALTH, KEEPING
PEOPLE FROM BECOMING PATIENTS IN
THE FIRST PLACE.
SO EXTENDING YOUR HEALTH SPAN,
THIS CAN BE DIAGNOSTIC AND
DETECTION TOOLS BUT WE ALSO KNOW
THAT THERE'S A LOT OF
PREVENTIBLE DISEASES OUT THERE.
SO WHAT ARE INVESTMENT IN
BEHAVIORAL SCIENCE FOR EXAMPLE
THAT MAY ADVANCE PRO-ACTIVE
HEALTH?
THREE OFFICES I JUST DESCRIBED,
IF YOU LIKE TO STUDY PNS
INNOVATION, P PRODUCT IS REALLY
ON THE LEFT-HAND SIDE,
DEVELOPING THE TOOLS THAT
SYSTEMS LEVEL, S-TYPE, BUILDING
INTEGRATED HEALTH CARE SYSTEMS.
THROUGH THE LAST THREE YEARS WE
DO NOT HAVE A RESILIENT HEALTH
CARE SYSTEMS IN THE UNITED
STATES, WE CAN IMPROVE, HOW DO
WE CREATE SYSTEMS THAT CAN WITH
STAND CRISES LIKE PANDEMICS,
SOCIAL DISRUPTION, CLIMATE
CHANGE, ECONOMIC INSTABILITY,
WHAT ARE INVESTMENTS THAT MAYBE
TAKE INNOVATION THAT'S ALREADY
OUT THERE BUT WHAT'S MISSING IS
DIGITAL LAYER THAT BRINGS THOSE
ALL TOGETHER, A SINGLE STANDARD
FOR A DASHBOARD THAT REPORTS
THAT INFORMATION.
I KNOW I'M PREACHING TO THE
CHOIR IN THE NIAID INFECTIOUS
DISEASE COMMUNITY THAT A LOT OF
THESE STANDARDS AND
COMMUNICATING INFORMATION DON'T
EXIST.
WE SHARED THIS, LUCKY ENOUGH TO
BE INVITED BY NIH COLLEAGUES TO
PARTICIPATE IN THE GATES
FOUNDATION WORKSHOP THINKING
ABOUT GLOBAL HEALTH, SOME
EXAMPLES ARE IMAGINE IF WE COULD
CREATE SOME PROGRAMMABLE
THERAPIES, COMMON GENE
MODULATION TOOL TO TREAT
MULTIPLE DISEASES INCLUDING RARE
DISEASES?
SO THINKING LIKE A Cas9 TO
KNOCK DOWN ACE-2 RECEPTION TO
PREVENT SARS-COV-2 INFECTION IN
LUNGS.
SCALABLE SOLUTIONS, CHALLENGES
THAT DON'T REQUIRE COLD STORAGE
OR NEEDLES, WE JUST USE POSTAL
SERVICE TO DELIVER TESTS.
WHAT ABOUT VACCINES?
WHAT DOES IT LOOK LIKE TO
ACHIEVE THAT?
I GAVE THE EXAMPLE OF 3D
HISTOPATHOLOGY.
THE TYPES OF PROGRAMS THAT WE
MIGHT EXPECT, THESE ARE THE
PROGRAM MANAGERS WE WANT TO
RECRUIT.
MY BIG REQUEST FOR THIS GROUP
RIGHT NOW IS I CAN'T SPEND THE
MONEY THAT I'VE BEEN GIVEN BY
THE CONGRESS UNTIL I HAVE
PROGRAM MANAGERS ON BOARD THAT
ARE ABLE TO DEFINE THE PROBLEM
THEY WANT TO SOLVE AND LAUNCH
THOSE INTO THE FUTURE.
MAYBE THERE'S MEMBERS ON THE
LINE NOW THAT WANT TO BECOME
PROGRAM MANAGERS OR MAYBE YOU
KNOW SOMEBODY IN YOUR NETWORK.
PLEASE THINK ABOUT THE FOLKS
THAT WANT TO CHANGE THE
DIRECTION IN THEIR FIELD,
PASSIONATE ABOUT SOLVING THEIR
PROBLEM, WILLING TO COME ON FOR
A TERM APPOINTMENT, BASE OF
THREE YEARS, RENEWABLE UP TO
SIX.
WE CAN OFFER A COMPETITIVE
SALARY.
SO I'M VERY LUCKY I HAVE DIRECT
HIRING AUTHORITY THAT'S BEEN
GIVEN TO ME BY THE CONGRESS SO
IF WE IDENTIFY GREAT CANDIDATE I
CAN HIRE THEM NEXT WEEK.
THERE'S NOT A VERY LONG JOB
APPLICATION PROCESS.
AND WE CAN HIRE UP TO THE
PRESIDENT'S SALARY, OUTSIDE OF
THE GS SCALE, ATTRACTIVE TO MANY
FOLKS IN INDUSTRY.
WE HAVE A COMMITMENT OF COURSE
TO DIVERSITY, IN GEOGRAPHY AND
DEMOGRAPHICS AND EXPERIENCE.
SO GOVERNMENT, INDUSTRY,
ACADEMIA AND THE TOPICS, WE WANT
A DIVERSITY OF TOPICS ESPECIALLY
AS WE LAUNCH THIS ORGANIZATION
SO WE CAN SHOW JUST THE SPECTRUM
AND CONTINUUM OF WORK ARPA-H CAN
REALLY FACILITATE GOING FORWARD.
KNOW THAT PERSON IS JOINING A
TEAM, THEY ARE NOT MEANT TO
CHANGE THE DIRECTION OF THEIR
FIELD ALONE.
WE HAVE THIS ENTIRE BUSINESS
TEAM ALSO VISIONARIES AND
INNOVATORS FINDING THE RIGHT
WAYS TO DO CONTRACTING TO REALLY
ACHIEVE THOSE GOALS, FOR
EXAMPLE, AND ALSO HAVING A TEAM
TYPICALLY EACH PROGRAM MANAGER
WILL HAVE A TEACH OF CONTRACTORS
THEY CAN HIRE THAT ARE SUBJECT
MATTER EXPERTS TO HELP THEM RUN
THE DAY-TO-DAY OF THE PROGRAMS.
PROGRAM MANAGERS, THEY HAVE THIS
SERIOUS DRIVE, VERY PASSIONATE
ABOUT SOLVING THEIR PROBLEM BUT
NOT AFRAID TO FAIL AND THEY ARE
VERY TECHNICALLY HONEST.
THEY CAN SAY YOU KNOW WHAT?
THIS ISN'T WORKING.
AND WE'RE NOT GOING TO KEEP JUST
BRUTE FORCING THIS CHALLENGE.
WE NEED TO FIND ANOTHER WAY.
SO THE FOLKS WILLING TO TAKE
THOSE HARD CONVERSATIONS ARE
REALLY IMPORTANT.
THEY CAN BE AT ANY STAGE, EARLY
STAGE CAREER, UNBIASED, LOOKING
WITH FRESH EYES, VISIONARY, OR
MAYBE MID-CAREER, STATUS QUO AND
THERE'S A BLOCKER IN THEIR FIELD
THEY CAN'T GET PAST AND WANT TO
JUMP IN TO ARPA-H FOR A FEW
YEARS AND UNSTICK THAT IN THEIR
FIELD AND BE A BENEFICIARY OF
THAT WHEN THEY COME BACK TO IT
ON THE OTHER SIDE.
SO, WE SEE ARPA-H AS AN
ORGANIZATION THAT WILL HELP
THESE FOLKS LEVEL UP, NOT ONLY
THEIR FIELD BUT THEMSELVES IN
THEIR CAREER.
AGAIN, SUCCESS FOR US IS WHEN
SOMETHING CAN ACTUALLY SURVIVE
IN THE REAL WORLD, AND WE
BELIEVE THAT RESEARCH GRANTS
AREN'T THE BEST WAY TO DO THAT,
REALLY USING CONTRACTING
VEHICLES LIKE COOPERATIVE
AGREEMENTS, DIRECT CONTRACTS AND
OTHER TRANSACTIONAL AUTHORITIES
WILL BE THE WAY THAT WE MOVE
FORWARD IN OUR ORGANIZATION.
THE LAST IS THE PROJECT
ACCELERATORS OFFICE, PATIO, OUR
THEME IS GOING TO BE SETTING UP
THOSE EARLY MARKET ASSESSMENTS
MAKING SURE WE'RE USING
HUMAN-CENTRIC DESIGN IN OUR
PROCESSES IF WE'RE GOING TO MAKE
A SOFTWARE TOOL SO SOMEBODY
WANTS TO USE IT AND IT'S
INTUITIVE.
HELP DEVELOP BAAs, MAKING SURE
WE'RE ADDRESSING ALL THE RIGHT
COMMUNITIES THAT NEED TO BE
RESPONDING TO A PROGRAM AND THEN
EARLY ON UNDERSTANDING WHAT IS
THE INVESTMENT IN THE TRANSITION
COMMUNITY SEEING AS A RISK, MAKE
SURE WE'RE DE-RISKING THOSE
PARTS, TECHNICAL AND OTHER
RISKS.
IN TERMS OF MANAGEMENT TEAM WE
MAY BE ESTABLISHING, MEANT TO
ADDRESS ALL OF THAT BECAUSE WE
WANT SOLUTIONS TO SURVIVE IN THE
WILD SO GOVERNMENT AND OTHERS
CAN ULTIMATELY BE A CUSTOMER.
I JUST STARTED IN OCTOBER SO
WE'RE REALLY A START-UP.
LITERALLY JUST LAUNCHED A
WEBSITE ABOUT A MONTH AGO.
SO, PLEASE CHECK OUT ARPA-H.GOV,
FIND THE PROGRAM MANAGER LANDING
PAGE AND TECHNICAL AREAS I
MENTIONED.
WE HAVE A ROBUST PM PIPELINE BUT
NARROWING DOWN THE FUNNEL OF
CANDIDATES IS HARD.
WE'RE GOING TO BRING IN THE
FIRST P.M.s THIS QUARTER, WE
SHOULD HAVE PROGRAMS LAUNCHING
IN THE SECOND AND THIRD QUARTERS
OF THIS YEAR.
WE HEARD ABOUT CONGRESS IN THE
LAST PRESENTATION, AND SO WHAT I
SPENT A LOT OF TIME BEFORE THE
END OF LAST YEAR WAS MEETING
WITH OVER 30 MEMBERS OF CONGRESS
TO REALLY LOCK IN OUR
AUTHORITIES IN THE OMNIBUS WHICH
I'M PLEASED TO SAY THAT WE WERE
SUCCESSFUL WITH AND WE'RE
STARTING TO NOW ENGAGE
UNIVERSITIES AND THOSE PATIENT
ADVOCACY GROUPS THAT ARE GOING
TO BE NOT JUST PERFORMERS BUT
MAIN BENEFICIARIES FOR US.
WE LOVE WORKING TOGETHER WITH
NIH.
HERE IS TARA SCHWETZ
THEY CAME TO OUR LAUNCH AT
HOWARD UNIVERSITY.
WE WANT TO ENGAGE MINORITY
COMMUNITIES AND SO IT WAS
IMPORTANT TO LAUNCH AND MAKE
SURE WE GET PROGRAM MANAGERS AND
PERFORMERS.
WE'RE MEETING WITH I.T.
DIRECTORS TO, STARTED SMALLER
BRAINSTORMING SESSIONS WHAT ARE
SOME CONCEPTES WE COULD PURSUE.
WE'VE BEEN VERY LUCKY TO HAVE AN
OPEN DOOR WITH NIH AS WE START
TO LAUNCH AND WORK TOGETHER.
I'LL LEAVE WITH THIS CALL TO
ACTION, HAPPY IF THERE'S TIME TO
TAKE ANY QUESTIONS.
AGAIN, PROGRAM MANAGERS ARE OUR
TOP PRIORITY THAT WE'RE HIRING
SO PLEASE EITHER CONSIDER THAT
YOURSELF OR SEND THOSE UNICORNS
OF GREAT CV PLUS BIG PROBLEMS
THEY WANT TO SOLVE, SEND THOSE
FOLKS OUR WAY.
THANKS AGAIN FOR INVITING ME.
>>RENEE, A GREAT PRESENTATION.
I'VE HEARD PORTIONS BEFORE, I
THINK IT GETS BETTER EACH TIME.
ONE QUESTION FROM ME AND LET'S
OPEN IT UP.
I'VE SEEN A NUMBER OF PLACES
SUGGEST YOU SHOULDN'T GO TO NIH
EMPLOYEES TO FIND YOUR PROGRAM
MANAGERS.
HOW STRONGLY DO YOU FEEL THAT
WAY?
>>WELL, I'LL TELL YOU HOW
STRONGLY CONGRESS FEELS ABOUT
IT.
IN THE OMNIBUS THEY HAVE CREATED
A RESTRICTION THAT THE --
ANYBODY WHO WORKED AT NIH IN THE
LAST THREE YEARS NEEDS TO
RECEIVE A WAIVER TO AN ARPA-H
EMPLOYEE, IT'S NOT JUST PROGRAM
MANAGERS, IT'S ACROSS THE BOARD.
I WILL EMPLOY THE WAIVER IF I
NEED TO BECAUSE I WOULD HOPE I
SHOULD BE TRUSTED TO HIRE THE
BEST AND BRIGHTEST, BUT
CERTAINLY INCLUDING FOLKS THAT
MAY BE AT NIH.
SO WE ARE OPEN TO IT BUT THAT IS
INDEED THE RESTRICTION IN PLACE
AT THE MOMENT.
>>GOT IT.
KEITH JEROME WAS THE FIRST HAND
I SAW.
>>YEAH, UNIVERSITY OF
WASHINGTON, SEATTLE, YOUR
DISCUSSION HOW THE HALMIRE
FRAMEWORK, THE STAGE AND
MATURITY OF IDEAS THIS IS REALLY
BUILT TO MOVE FORWARD, THE
NATURAL TENSION BETWEEN THINGS
TOO MATURE VERSUS WHAT MAY BE
GROUNDBREAKING.
>>I APPRECIATE THE QUESTION.
WHEN THE TECHNOLOGY READINESS
LEVEL, FROM ONE BEING NEVER
SHOWN BEFORE PROOF OF CONCEPT TO
NINE BEING SOMETHING YOU CAN BUY
OFF THE SHELF AT CVS, WE'RE
GOING TO FOCUS ON ONE THROUGH
FIVE, WITH SYSTEMS INTEGRATION,
WE'LL LOOK AT SOME OF THOSE
PROOFS OF CONCEPTS WHERE THINGS
NEED TO BE PULLED TOGETHER, AND
SYSTEM INTEGRATION.
WE'LL EXPLORE THE RANGE BUT TO
THE POINT ABOUT A PUBLICATION WE
DON'T NEED TO SEE PROOF THAT
SOMETHING WORKS.
WE NEED TO SEE PROOF IN APPROACH
BUT WHAT WE WANT TO SEE FROM
PROGRAM MANAGERS IS THEY REALLY
THOUGHT THROUGH LIKE HOW CAN
THEY BE SUCCESSFUL THAT THERE'S
SIGNALS OUT THERE, MAYBE IT'S A
PATENT, BUT MAYBE IT'S NOT.
MAYBE THEY JUST HAVE THIS EUREKA
MOMENT PUTTING THINGS TOGETHER
THEY WILL BE ABLE TO SOLVE THIS
PROBLEM BUT WE WANT THEM TO WALK
US THROUGH THEIR LOGIC.
THERE'S A TON OF GREAT IDEAS OUT
THERE.
LOTS OF LACK OF EXECUTION.
SO IT'S REALLY AN EXECUTION
THERE'S GOING TO BE -- THAT
WE'RE GETTING IT'S A IN THAT
NUMBER THREE.
>>RITU AGRAWAL.
>>YOU MENTIONED YOU WON'T HAVE
STANDARD STUDY SECTIONS AND
INDICATED YOU MAY CALL UPON SOME
SUBJECT NIH SUBJECT MATTERS
EXPERTS TO COMMENT ON PROPOSALS
YOU GET OR PROGRAM MANAGERS
GENERATE.
MY QUESTION IS, YOU KNOW, HAVE
YOU THOUGHT THROUGH WHAT THIS
NEW PEER REVIEW PROCESS MIGHT
LOOK LIKE, IF YOU COULD SAY
SOMETHING ABOUT THAT?
THE SECOND QUESTION RELATES TO
KEITH'S POINT, ALONG THE
CONTINUUM OF BASIC DISCOVERY,
TWO THINGS IMMEDIATELY
COMMERCIALIZABLE, YOU MENTIONED
THESE ARE NOT RESEARCH GRANTS SO
IF YOU COULD SPEAK A LITTLE BIT
TO THAT.
>>YES, FIRST ON THE PEER
REVIEW, IT'S NOT A NEW PROCESS.
WE'RE ADOPTING THE PROCESS USED
BY DARPA.
>>OKAY.
>>SO THE WAY THAT WORKS IS
WE'LL IDENTIFY EXPERTS THAT CAN
WEIGH IN ON THE PROGRAM, AND SO
WHETHER THOSE ARE FROM
GOVERNMENT OR INDUSTRY THEY WILL
GO THROUGH ETHICS, LIKE YOU
WOULD FOR ANY OTHER REVIEW.
AND WE'LL SET EVALUATION
CRITERIA.
SO TYPICALLY THOSE ARE, YOU
KNOW, IS THIS TECHNICALLY
POSSIBLE, WHAT ABOUT COST
REALISM?
WE'RE NOT TRYING TO NICKEL AND
DIME THE PROJECT BUT HAVE THEY
PROPOSED ENOUGH FUNDS TO ACHIEVE
THAT THEY SAY THEY WANT TO DO
AND IS THIS JUSTIFIED?
THE OTHER CRITERIA IS REALLY
LOOKING AT THE TEAM THEY HAVE IN
PLACE.
DO WE HAVE -- ARE THE RIGHT
EXPERTS HERE, PROGRAM MANAGER
MAY ADD OTHERS.
WE ASK FOR THOSE REVIEWERS WE
INVITE FROM NIH AND OTHER PLACES
TO WEIGH IN.
THE PROGRAM MANAGER WILL TAKE
THOSE INSIGHTS IN THEIR FINAL
DECISION BUT AGAIN THE PROGRAM
MANAGER MAKES A DECISION.
THEY MAY DISAGREE WITH
REVIEWERS, COMPLETELY FINE.
AND SO THEY SHOULD JUSTIFY, WHY
THEY DISSENT, WHAT THE REVIEWER
SAYS BUT IT'S THEIR DECISION SO
THEY CAN TAKE THOSE RISKS.
[AUDIO DISTORTION]
FOR THE FUNDING WE HAVE HAVEN'T
ALLOCATED -- LOOKS LIKE I'M
HAVING AN UNSTABLE INTERNET
MESSAGE HERE.
THE FUNDS, THE PROGRAMS, THERE'S
A SMALL OPERATING BUDGET WE NEED
TO USE BUT PREDOMINANT FUNDS
WILL BE USED FOR THOSE FUNDS.
FOR THOSE PROGRAM MANAGERS.
SO AS WE HIRE THEM THAT'S HOW I
KNOW WHAT WE'LL SPEND THE MONEY
ON.
SO THAT'S -- BUT IT'S NOT BEEN
PRE-DETERMINED.
THAT IS ONE OF THE FREEDOMS
GIVEN TO THE ORGANIZATION THAT
WE SELECT ON A ROLLING BASIS
WHAT PROJECTS THAT WE'LL FUND.
>>THANK YOU.
>>ANY OTHER QUESTIONS FOR DR.
WEGRYZN?
SEEING NONE, THANK YOU, RENEE
FOR JOINING US.
>>WE'LL TAKE A FIVE-MINUTE
BREAK TO PREPARED FOR THE CLOSED
SESSION.
WE ASK ALL NON-GOVERNMENT
EMPLOYEES LEAVE THE ROOM.
COUNCIL MEMBERS SHOULD REMAIN SO
WE CAN GO TO THE CLOSED SESSION
TO REVIEW GRANT APPLICATIONS.