HELLO, EVERYONE.
WELCOME TO TODAY'S WEBINAR
FOCUSED ON A DRAFT POLICY
PROPOSAL ISSUED BY THE NIH TO
REALLY THINK ABOUT HOW TO
PROMOTE EQUITY THROUGH ACCESS
PLANNING.
I AM LYRIC JORGENSON, ASSOCIATE
DIRECTOR FOR SCIENCE POLICY HERE
AT THE NATIONAL INSTITUTES OF
HEALTH.
SO AGAIN I'D LIKE TO WELCOME YOU
FOR JOINING US TODAY.
WE ARE REALLY EXCITED TO HAVE
THIS CONVERSATION WITH OUR
COMMUNITY AND ARE GRATEFUL FOR
YOUR INTEREST IN THE TOPIC.
NOW AS MANY OF YOU LIKELY KNOW,
ON MAY 21ST, NIH ANNOUNCED A
REQUEST FOR INFORMATION, A WAY
THAT WE OFTEN SEEK INPUT FROM
THE PUBLIC, ON A DRAFT PROPOSED
POLICY FOR THE AGENCY'S
INTRAMURAL RESEARCH PROGRAM
WHICH WE'LL BE TALKING ABOUT
MORE IN DETAIL THROUGH TODAY'S
WEBINAR.
THE POLICY REALLY FOCUS ON HOW
TO PROMOTE EQUITY THROUGH
VEHICLES SUCH AS ACCESS PLANNING
SOME OF THE PATIENT ACCESS
CONSIDERATIONS INTO THE
COMMERCIALIZATION PROCESS FOR
NIH-OWNED INVENTIONS.
THIS PROPOSAL WOULD CALL ON BOTH
THE AGENCY AND OUR PARTNERS TO
WORK TOGETHER THROUGH THE PATENT
LICENSING PROCESS TO BE CREATIVE
AND EXPLORE WAYS TO EXPAND THE
REACH OF OUR NIH ACTIVITIES INTO
THE HANDS OF PATIENT, ESPECIALLY
AROUND THINGS LIKE NEW DRUGS
THAT ARE DEVELOPED BASED ON NIH
INVENTIONS.
SO OUR GOALS FOR TODAY IS TO
TELL YOU MORE ABOUT THIS POLICY
PROPOSAL, PROVIDE INFORMATION
RELEVANT TO THE RFI, ESPECIALLY
WITH AN EYE TOWARDS EQUIPPING
INTERESTED INDIVIDUALS AND
COMMUNITIES WITH THE BACKGROUND
AND CONTEXT FOR ANYONE NOT
FAMILIAR WITH THE NIH INTRAMURAL
PROGRAM FOR THE WORK WE'RE DOING
TODAY.
SO DURING THE NEXT HOUR WE'LL
HEAR A PRESENTATION ABOUT THE
NIH INTRAMURAL RESEARCH PROGRAM
FROM ONE OF THE LEADERS AT THE
AGENCY'S INTERNAL RESEARCH ARM.
OUR PRESENTERS WILL DISCUSS
PATENT LICENSING AT NIH, REVIEW
THE CONCEPT OF ACCESS PLANNING
AND DISCUSS THE RFI AND POLICY
PROPOSAL LED BY ABBY REEVES, THE
HEAD OF OUR STRATEGIC INNOVATION
OF TECHNOLOGY TRANSFER POLICY.
BEFORE WE DIVE IN I WANT TO
OFFER A FEW REFLECTIONS ON THIS
POLICY PROPOSAL.
NOW IT WILL COME AS NO SURPRISE
TO ANYONE HERE TODAY THAT NIH'S
INVESTMENTS HAVE PROVEN TO BE A
CATALYST FOR NEW DRUG
DEVELOPMENT.
THROUGH THE RESEARCH WE FUND AND
CONDUCT, WE HAVE SPURRED PRIVATE
SECTOR INVESTMENTS IN INNOVATION
AND NEW THERAPIES THAT HAVE BEEN
CRITICAL FOR AMERICAN INNOVATION
AND HEALTH.
NIH HAS GENERATED BROAD RETURNS
FOR PUBLIC HEALTH AND THE U.S.
ECONOMY.
SO AS I MENTIONED, DR. TARA
KIRBY WILL SOON SHARE MORE ABOUT
SPECIFIC WAYS THE INTRAMURAL
RESEARCH PROGRAM CONTRIBUTES TO
THESE SUCCESSES.
I ALSO WANT TO EMPHASIZE THAT
ALL OF NIH'S ACTIVITIES ARE
DRIVEN BY THE PRINCIPLE THAT OUR
WORK IS NOT FINISHED WHEN WE
DELIVER SCIENTIFIC DISCOVERIES.
AS YOU'LL HEAR, THE NIH
DIRECTOR, DR. MONICA BERTAGNOLLI
SAY, OUR WORK IS FINISHED WHEN
ALL PEOPLE ARE LIVING LONG AND
HEALTHY LIVES.
SO WHEN WE THINK ABOUT
OPTIMIZING OUR ABILITY TO
DELIVER ON NIH'S MISSION, WE
KNOW THAT INVOLVES SEVERAL
COMPONENTS.
FIRST, WE KNOW WE NEED TO MAKE
SURE THAT THE GREAT IDEAS THAT
COME OUT OF NIH'S WORK CAN GET
OUT THERE INTO THE HANDS OF
OTHERS AND IMPROVE PEOPLE'S
LIVES.
SECOND, PEOPLE'S LIVES CAN ONLY
GET BETTER IF THEY CAN ACTUALLY
ACCESS THE PRODUCTS AND SERVICES
THAT ARE BUILT ON THE FOUNDATION
WE BUILD.
TO THAT END, NIH IS THINKING
ABOUT ITS CURRENT POLICY AND
APPROACHES AS A RESEARCH
INSTITUTION AROUND FACTORS THAT
CAN SHAPE INNOVATION,
COMPETITION AND PATIENT ACCESS
TO CUTTING EDGE MEDICAL
TECHNOLOGY.
IMPORTANTLY WE RECOGNIZE NIH
CANNOT ACHIEVE OUR MISSION OR
REALIZE PUBLIC HEALTH BENEFITS
IF PEOPLE CANNOT ACCESS PRODUCTS
THAT EMERGE FROM OUR WORK.
THUS WE ARE COMMITTED TO
ADVANCING EQUITY IN THE
APPLICATION OF NIH RESEARCH SO
THAT ALL BENEFITS OF OUR WORK
ARE AVAILABLE AND AFFORDABLE TO
ALL AMERICANS.
AT THE SAME TIME, WE RECOGNIZE
THAT BIOMEDICAL RESEARCH AND
HEALTHCARE ECOSYSTEMS ARE
INCREASINGLY COMPLEX, AND THAT
MEANS WE NEED TO THINK NOT ONLY
CREATIVELY BUT STRATEGICALLY
ABOUT HOW WE CAN SOLVE OR
PRESENT THE CHALLENGES FOR
PATIENTS ACCESSING THE CARE THEY
NEED.
IMPORTANTLY TODAY'S CONVERSATION
IS AROUND ONLY ONE PIECE ON
NIH'S INVESTMENT IN IMPROVING
PATIENT OUTCOMES.
FOR THOSE OF YOU THAT HAVE NOT
ALREADY HEARD, LAST WEEK NIH
ANOWBSED A NEW INITIATIVE CALLED
COMMUNITIES ADVANCING RESEARCH
EQUITY FOR HEALTH, OR CARE FOR
HEALTH, WHICH SEEKS TO IMPROVE
ACCESS TO CLINICAL RESEARCH TO
INFORM MEDICAL CARE,
PARTICULARLY FOR THOSE IN
COMMUNITIES HISTORICALLY
UNDERREPRESENTED IN CLINICAL
RESEARCH OR UNDERSERVED IN
HEALTHCARE SETTINGS.
FINALLY BEFORE I TURN IT OVER TO
OUR ESTEEMED SPEAKERS TODAY, I
WANT TO HIGHLIGHT WHERE NIH IS
IN THE POLICY DEVELOPMENT
PROCESS, THE RELEASE OF LAST
MONTH'S REQUEST FOR INFORMATION
REFLECTS OUR VERY SINCERE
COMMITMENT TO ENGAGING WITH THE
PUBLIC TO INFORM OUR POLICIES.
ONE OF MY HIGHEST PRIORITIES
HERE AS THE ASSOCIATE DIRECTOR
FOR SCIENCE POLICY IS MAKING
SURE EVERYONE HAS AN EQUAL
OPPORTUNITY AND CAN CONTRIBUTE
MEANINGFULLY TO THE POLICY
DEVELOPMENT PROCESS.
OUR EARS ARE OPEN AND WE ARE
LISTENING.
WE ENCOURAGE ANYONE WHO WANTS TO
SUBMIT PERSPECTIVES, FEED BACKS
OR IDEAS ON THIS DRAFT PROPOSED
POLICY TO US AT OUR LINK.
WE ARE LISTENING.
BEFORE I TURN OVER TO MIKE, I
WANT TO ADDRESS A FEW
HOUSEKEEPING ITEMS.
AS LIKELY YOU KNOW, THIS WEBINAR
IS BEING VIDEOCAST BY NIH.
IT WILL BE RECORDED AND IT WILL
BE AVAILABLE FOR THOSE WHO
COULDN'T JOIN US LIVE TODAY.
NOW I'M EXCITED TO KICK OFF
TODAY'S DISCUSSION AND TURN
THINGS OVER TO DR. TARA KIRBY AS
I MENTIONED WHO WILL PROVIDE
MORE BACKGROUND ABOUT THE
INTRAMURAL PROGRAM AND DISCUSS
PATENT LICENSING AT NIH, AND
THEN SHE WILL BE JOINED BY,
AGAIN, ABBY RIVES, DIRECTOR OF
TECHNOLOGY TRANSFER AND
INNOVATION POLICY AT NIH OSP.
DR. KIRBY.
>> THANK YOU, LYRIC, AND THANKS
TO EVERYBODY WHO'S BEEN ABLE TO
JOIN US TODAY.
I'M GOING TO START BY PROVIDING
SOME BACKGROUND THAT I HOPE WILL
HELP US TO PUT THIS POLICY
PROPOSAL INTO CONTEXT.
FIRST OF ALL, WHAT DO WE MEAN
WHEN WE TALK ABOUT THE NIH
INTRAMURAL RESEARCH PROGRAM OR
IRP?
NEXT I'LL TALK GENERALLY ABOUT
HOW WE LICENSE TECHNOLOGIES FROM
THE IRP, WHY WE DO IT, HOW WE DO
IT AND WHY IT MATTERS.
SO AS WE STEP OUT TO SEE THE BIG
PICTURE, AS MANY OF YOU KNOW,
THIS IS NIH'S MISSION.
AND THE LAST TWO LINES, I THINK
ARE VERY IMPORTANT HERE, BECAUSE
OUR DISCUSSIONS ARE GOING TO
REALLY FOCUS ON THIS PIECE,
ABOUT APPLYING KNOWLEDGE TO
ENHANCE HEALTH, LENGTHEN LIFE
AND REDUCE ILLNESS AND
DISABILITY.
MOST PEOPLE KNOW THAT NIH
SUPPORTS BASIC RESEARCH, IT
ACCOUNTS FOR MORE THAN HALF OF
OUR BUDGET AND IT'S CRITICAL TO
FUELING PROGRESS FOR NEW
TREATMENTS AND CURES.
WE ALSO FOCUS ON TRANSLATIONAL
RESEARCH THAT HELPS US MOVE
BASIC DISCOVERIES FORWARD, AND
CLINICAL RESEARCH WHICH IS
NEEDED TO REALLY TURN
DISCOVERIES INTO PREVENTIONS,
TREATMENTS AND CURES.
WHEN WE THINK ABOUT OPTIMIZING
OUR ABILITY TO DELIVER ON THIS
MISSION, WE KNOW THAT INVOLVES
SEVERAL COMPONENTS, INCLUDING
THAT WE NEED TO MAKE SURE THAT
OUR GREAT IDEAS THAT COME OUT OF
NIH'S WORK, AS LYRIC MENTIONED,
CAN ACTUALLY GET OUT THERE TO
THE WORLD AND IMPROVE PEOPLE'S
LIVES.
AND ALSO THAT PEOPLE'S LIVES CAN
ONLY GET BETTER IF THEY CAN
ACTUALLY ACCESS THE PRODUCTS AND
SERVICES THAT ARE BUILT ON OUR
WORK.
SO FOR FOLKS WHO DON'T ALREADY
KNOW, NIH IS MADE UP OF 27
DIFFERENT COMPONENTS CALLED
INSTITUTES, CENTERS AND OFFICES,
WHICH WE USUALLY REFER TO AS
ICs AND WHICH I'LL PROBABLY BE
SAYING HERE.
EACH IC HAS ITS OWN UNIQUE
MISSION, BUDGET, PRIORITIES,
LEADERSHIP AND FUNDING STRATEGY.
MOST OF THE ICs FUND AND
CONDUCT RESEARCH, THEY HAVE
THEIR OWN RESEARCH AGENDA AND
FOCUS USUALLY ON PARTICULAR
DISEASES OR BODY SYSTEMS.
24 OF THESE 27ICs HAVE
INTRAMURAL RESEARCH PROGRAMS.
THAT MEANS THEY CONDUCT INTERNAL
RESEARCH AT NIH, SPANNING FROM
BASIC, TRANSLATIONAL TO CLINICAL
RESEARCH AT ALL OF OUR
FACILITIES.
THE OFFICE OF THE DIRECTOR UP
THERE IN THE MIDDLE IS THE
CENTRAL OFFICE RESPONSIBLE FOR
SETTING POLICY FOR NIH AND
PLANNING, MANAGING AND
COORDINATING PROGRAMS ACROSS ALL
OF NIH COMPONENTS.
AND THIS HELPS US TO PROVIDE
INTEGRATIVE POLICIES AND
INFRASTRUCTURE ACROSS THE ICs.
MY OFFICE, THE OFFICE OF
TECHNOLOGY TRANSFER, IS PART OF
THE OFFICE OF THE DIRECTOR OR
THE OD.
WE WORK CLOSELY WITH OUR
PARTNERS IN THE TECHNOLOGY
TRANSFER OFFICES IN THE
INSTITUTES AND CENTERS TO ENABLE
TECH TRANSFER, SO THINGS LIKE
EXCHANGING MATERIALS AND DATA,
COLLABORATIONS, PATENTING, AND
LICENSING FOR OUR ENTIRE
INTRAMURAL RESEARCH PROGRAM.
I'LL EXPLAIN MORE ABOUT THAT
NEXT.
WE JUST SAW IN THE LAST SLIDE
THAT NIH HAS 27 ICs, BUT HOW
ARE THESE ICs ALLOCATING
RESOURCES?
WE CAN SEE A BREAKDOWN OF NIH'S
OVERALL BUDGET, HERE I'M SHOWING
THE BUDGET FOR 2022.
MOST OF NIH'S BUDGET IS SPENT
OUTSIDE THE AGENCY AND THAT'S
WHAT MOST PEOPLE KNOW BEST.
FOR EXAMPLE, GRANTS AND
CONTRACTS TO OUR EXTRAMURAL
FOLKS LIKE UNIVERSITIES, MEDICAL
SCHOOLS, OTHER SCIENTIFIC
INSTITUTIONS AND SMALL
BUSINESSES.
WE ALSO FUND GRANTS THAT SUPPORT
LARGE MULTI-PROJECT EFFORTS FOR
A WIDE ARRAY OF RESEARCH
ACTIVITIES AND ALSO TRAINING SO
THAT WE CAN HAVE A SKILLED
WORKFORCE AND PROVIDE FOR THE
NEXT GENERATION OF OUR
INVESTIGATORS.
BUT INTRAMURAL RESEARCH,
RESEARCH CONDUCTED BY NIH
SCIENTISTS THROUGH OUR INTERNAL
PROGRAMS, STILL TOTALS
$4.8 BILLION, OR ABOUT 11% OF
OWRP OVERALOUR OVERALL BUDGET, R
PROPORTIONS OVER THE YEARS.
SO NOW WE'RE GOING TO TALK ON
THIS SPECIFIC 11% SLICE.
SO AS YOU CAN IMAGINE, OUR IRP
IS VERY DIVERSE, BUT THIS SLIDE
PROVIDES A SNAPSHOT OF A FEW
WAYS TO UNDERSTAND ITS SCOPE.
WE HAVE MORE THAN 5,000
SCIENTISTS WORKING ON OVER 3,000
PROJECTS, AND MANY OF THOSE ARE
TRAINEES, AND WE ALSO HAVE A
LARGE NUMBER OF SENIOR
RESEARCHERS.
MANY OF THESE PROJECTS THAT ARE
OCCURRING RELY ON
COLLABORATIONS, AND IN 2023, WE
PUT MORE THAN 4600 COLLABORATION
AGREEMENTS INTO PLACE TO HELP
FACILITATE WORK BY OUR
RESEARCHERS, RANGING FROM
MATERIAL TRANSFERS, INFORMATION
TRANSFERS TO MULTIYEAR PROJECTS
AND CLINICAL TRIALS.
ALSO IN 2023, WE FILED A TOTAL
OF 187 NEW PATENTS FOR THE NIH
INTRAMURAL PROGRAM.
AND WE EXECUTED 273 LICENSES
THAT YEAR, ALSO, BOTH FOR
PATENTS AND OTHER INVENTIONS.
THE IRP IS BASICALLY THE LARGEST
BIOMEDICAL RESEARCH INSTITUTION
ON THE EARTH AND SOMETIMES FEELS
LIKE THAT HERE.
AND IT COVERS MANY DISEASE AREAS
AND TECHNOLOGIES FROM
FUNDAMENTAL DISCOVERIES TO
RESEARCH TOOLS TO INNOVATIONS
THAT MAY BECOME FUTURE DRUGS,
VACCINES, DEVICES AND OTHER
PRODUCTS TO BENEFIT THE PUBLIC.
SO I. WANTED TO GIVE JUST A VERY
BRIEF IDEA OF THE LEGAL
FRAMEWORK FOR NIH'S LICENSING.
WHAT ALLOWS US TO ENGAGE IN
LICENSING AND OTHER TECH
TRANSFER ACTIVITIES IN THE NIH
INTRAMURAL RESEARCH PROGRAM?
THERE IS A NETWORK OF LAWS THAT
GOVERN PATENTING AND LICENSING
OF GOVERNMENT-OWNED INVENTIONS.
THE FOUNDATIONAL LAW IS THE
STEVENSON WYDLER TECHNOLOGY
INNOVATION ACT OF 1980 WHICH
MANDATED THAT FEDERAL AGENCIES
TRANSFER THEIR TECHNOLOGIES TO
NON-FEDERAL PARTIES FOR
DEVELOPMENT.
THIS IS SUPPORTED BY OTHER LAWS
SUCH AS BAYH-DOLE, WHICH IS
PRIMARILY KNOWN AS THE LAW THAT
LETS RECIPIENTS OF FEDERAL
FUNDING TO OBTAIN TITLE TO
INVENTIONS.
BUT IT ALSO AUTHORIZED THE
GOVERNMENT TO EXCLUSIVELY
LICENSE ITS TECHNOLOGIES.
THE FTTA, FEDERAL TECHNOLOGY
TRANSFER ACT, DECENT LIETZED
GOVERNMENT TECH TRANSFER TO
INDIVIDUAL AGENCIES, WHICH IS
HOW OTT CAME INTO BEING.
THESE LAWS ARE CODIFIED IN 35USC
207-209 AND ALSO PROMULGATED IN
37 CFR 404.
THAT'S ESSENTIALLY OUR BIBLE
WHEN IT COMES TO HOW WE LICENSE
OUR OWN TECHNOLOGIES.
SO WE ARE PERMITTED TO LICENSE
OUR TECHNOLOGIES, BUT WHY DO WE
DO THAT ANYWAY?
A SUCCINCT STATEMENT OF THIS IS
IN 37SFR 404, TO PROMOTE THE
RESULTS OF FEDERALLY FUNDED
RESEARCH AND DEVELOP THE.
BUT IN PRACTICE, WHAT DOES THIS
MEAN?
GENERALLY WE WANT TO UTILIZE OUR
IP AS AN INCENTIVE FOR
COMMERCIAL DEVELOPMENT, AND
PATENT PROTECTION IN PARTICULAR
MAY BE A KEY INCENTIVE TO
DEVELOP RISKY BIOMEDICAL
TECHNOLOGIES.
LICENSING CAN ALSO ATTRACT NEW
R & D RESOURCES, FOR EXAMPLE,
WHEN A LICENSING PARTER IN IS
ABLE TO RAISE CAPITAL TO CONDUCT
A CLINICAL TRIAL.
WE ALSO WANT TO GET A RETURN ON
THE PUBLIC'S INVESTMENT, AND
CERTAINLY THAT MIGHT INVOLVE
RECOUPING THE FUNDS WE USE TO
CONDUCT OUR RESEARCH AND PAY FOR
PATENT COSTS, BUT EVEN MORE
IMPORTANTLY, WE WOULD LIKE TO
REALIZE THE POTENTIAL OF NIH'S
RESEARCH DISCOVERIES.
LICENSING IS ALSO A WAY TO
STIMULATE ECONOMIC DEVELOPMENT,
WHICH CAN MAKE THE INNOVATION
ECOSYSTEM MORE ROBUST AND HELP
TO DRIVE NEW DISCOVERIES IN ITS
TURN.
OF COURSE, THOUGH, NIH HAS A
VERY SPECIFIC REASON ALSO TO
LICENSE THIS TECHNOLOGY, WHICH
COMES BACK TO THE CORE PART OF
ITS MISSION, WHICH IS TO BENEFIT
THE PUBLIC HEALTH.
AND THIS IS GENERALLY OUR FIRST
CONSIDERATION IN ANY LICENSE
THAT WE NEGOTIATE.
SO WHILE THE IRP IS A SLICE OF
WHAT NIH DOES AND PA AT THE
PRESENT TIMAT THEPRPATENTING AN,
OUR LICENSES HAVE RESULTED IN
MORE THAN A THOUSAND PRODUCTS
BROUGHT TO MARKET OVER THE LAST
30 YEARS OR SO.
THESE INCLUDE AN IMPRESSIVE 46
FDA-APPROVED VACCINES AND
THERAPEUTICS, AND EVEN MORE
PRODUCTS HAVE BEEN AUTHORIZED
THROUGH OTHER AUTHORITIES SUCH
AS IN VITRO DIAGNOSTICS AND ALSO
PRODUCTS AUTHORIZED FOR USE IN
OTHER COUNTRIES.
AND ALSO IN ADDITION TO BRINGING
THESE IMPORTANT TECHNOLOGIES TO
MARKET, THE PROGRESS FOR R & D
IN A MORE BROAD SENSE.
IN A RECENT REPORT THAT WE PUT
TOGETHER DESCRIBING THE IMPACT
OF OUR LICENSING PROGRAM, WE
FOUND THAT IRP TECHNOLOGIES WERE
USED IN OVER 1200 CLINICAL
TRIALS AND WERE CITED IN
NUMEROUS PATENT APPLICATIONS
FILED BY OUR LICENSEES.
THE REPORT ALSO SHOWED THAT AS
IMPORTANT AS OUR FDA-APPROVED
PRODUCTS ARE AND THOSE LICENSES
ARE TO OUR OVERALL GOALS, THE
NIH ALSO HAS AN ENORMOUS IMPACT
THROUGH MAKING RESEARCH TOOLS
AVAILABLE TO INDUSTRY, AND THESE
ACCOUNT FOR OVER 60% OF OUR
LICENSES.
AND IN ACCORDANCE WITH THIS,
MOST OF OUR LICENSES ARE
NON-EXCLUSIVE.
I'D ALSO JUST LIKE TO TAKE A
MOMENT TO HIGHLIGHT A FEW OF THE
VACCINES AND THERAPEUTICS ON THE
MARKET THAT UTILIZE SOMETHING
DEVELOPED FROM THE IRP
TECHNOLOGY PROGRAM.
MANY PEOPLE ARE PROBABLY
FAMILIAR WITH COMIRNATY, A
COVID-19 VACCINE.
OTHER RECENT TECHNOLOGIES ARE
EBANGA, A HUMAN MONOCLONAL
ANTIBODY FOR TREATING EBOLA
VIRUS.
AREXVY IS AN RSV VACCINE FOR
INDIVIDUALS 60 YEARS OF AGE OR
OLDER.
ZOKINVY IS A DRUG THAT HELPS
PREVENT THE BUILDUP OF PROGERIA,
A DISEASE WHERE CHILDREN AGE
PREMATURELY.
AND ABECMA IS A CAR-T-CELL
THERAPY TREATMENT FOR MULTIPLE
MYELOMA.
THERE ARE EVEN MORE RECENT
APPROVALS THAT I HAVEN'T HAD THE
CHANCE TO PUT ON THE SLIDE, BUT
SOME OF THEM INCLUDE DRUGS FOR
TREATING HEMOPHILIA, WHICH IS
HAS BEEN A VERY ELUSIVE GOAL,
AND ALSO FOR THE TREATMENT OF
MELANOMA.
I'D ALSO LIKE TO TALK JUST FOR A
SECOND ABOUT WHO IS LICENSING
NIH'S TECHNOLOGIES.
OUR RECENT IMPACT REPORT
CONFIRMED SOMETHING THAT WE
ALREADY KNEW, IT'S NOT JUST BIG
PHARMAS AND BIOTECH COMPANIES
THAT LICENSE FROM US.
IN FACT, FOR OUR MOST SUCCESSFUL
TECHNOLOGIES, ABOUT A THIRD OF
THEM WERE LICENSED BY
EARLY-STAGE COMPANIES.
THIS WAS TRUE ACROSS PRODUCT
TYPES, DIAGNOSTICS, RESEARCH
TOOLS, THERAPEUTICS AND DEVICES.
AND THAT PROBABLY REFLECTS THE
FACT THAT SOMETIMES SMALL
COMPANIES ARE THE ONLY ONES
WILLING TO TAKE ON THE
SUBSTANTIAL RISK OF AN EARLY
STAGE TECHNOLOGY, WHICH IS THE
VAST MAJORITY OF THE
TECHNOLOGIES NIH HAS.
PEOPLE ALSO ASSUME NIH ONLY
LICENSES TO U.S. COMPANIES.
AND THAT'S DEFINITELY NOT TRUE.
ONE OF EVERY THREE OF OUR
LICENSES IS TO A FOREIGN
COMPANY.
IF YOU THINK ABOUT THIS, IT
MAKES SENSE.
IN BIOMEDICAL RESEARCH,
INTERNATIONAL COLLABORATIONS ARE
OFTEN A CRITICAL PART OF
SUPPORTING THE BEST SCIENCE
INNOVATION, AND SOME
TECHNOLOGIES LIKE THOSE FOR
NEGLECTED TROPICAL DISEASES MAY
BE BEST SUITED FOR DEVELOPMENT
BY AN INTERNATIONAL PARTNER THAT
HAS THE APPROPRIATE REGIONAL
EXPERTISE AND RESOURCES.
BOTH THE LEGAL FRAMEWORK FOR
GOVERNMENT LICENSING, WHICH I'VE
ALREADY TALKED ABOUT, AND NIH'S
GOALS FEED INTO OUR GENERAL
PRINCIPLES THAT WE FOLLOW FOR
LICENSING TECHNOLOGIES FROM THE
IRP.
FIRST, WE WANT TO DO OUR BEST TO
GRANT THE APPROPRIATE SCOPE OF
RIGHTS.
THE LICENSE SHOULD REFLECT THE
LICENSEE'S PLANS AND ABILITIES
TO DEVELOP THE TECHNOLOGY AND
NOT BE A BLANKET GRANT.
THIS MEANS TAILORING THE FIELD
OF USE, THE TERRITORY WHERE THE
LICENSEE CAN MAKE OR SELL THE
PRODUCT OR SERVICE, AS WELL AS
OTHER FACTORS.
THIS ALSO INCLUDES LICENSING
NON-EXCLUSIVELY WHEREVER
POSSIBLE OR LIMITING
EXCLUSIVITY.
I'VE ALREADY MENTIONED THAT MOST
OF OUR LICENSES ARE NOT
EXCLUSIVE, AND THIS IS NOT AN
ACCIDENT.
WE WANT TO ALLOW THE BROADEST
POSSIBLE DEVELOPMENT AND
DISSEMINATION OF THE TECHNOLOGY
IN ALL OF THESE ASPECTS IF WE
CAN.
IT'S ALSO CRITICAL TO US AS A
RESEARCH INSTITUTION TO PRESERVE
RESEARCH USE OF THE TECHNOLOGY,
BOTH BY NIH AND BY OTHERS, SO
THAT FURTHER R & D CAN BE
FACILITATED AND WE CAN DEVELOP
NEW TECHNOLOGIES.
OUR LICENSES ALSO INCLUDE
ENFORCEABLE MILESTONES AND
BENCHMARKS THAT LET US TRACK HOW
THE LICENSEE IS DOING AS IT
DEVELOPS AND EVENTUALLY
COMMERCIALIZES OUR TECHNOLOGIES.
AND ALLOWS US TO GET INVOLVED IF
THINGS GO OFF TRACK, AND I CAN
TELL YOU A LITTLE BIT MORE ABOUT
THAT IN A MINUTE.
WE ALSO WANT A LICENSING
STRATEGY THAT LETS US GET THE
MOST OUT OF OUR TECHNOLOGIES.
MANY OF THEM, PARTICULARLY
FOUNDATIONAL ONES LIKE THE SARS
STABILIZED SPIKE PROTEIN
TECHNOLOGY THAT WAS THE BASIS OF
THE COVID-19 VACCINE, MANY OF
THESE TECHNOLOGIES HAVE MULTIPLE
USES.
SO MORE LICENSES FOR MORE USES
EXPANDS THE POTENTIAL FOR PUBLIC
BENEFIT.
AND OF COURSE WE WANT TO ENSURE
AN APPROPRIATE RETURN ON THE
PUBLIC'S INVESTMENT.
NOW I'M GOING TO TALK A LITTLE
BIT ABOUT NIH'S LICENSING
PROCESS.
THIS COULD BE AN ENTIRE TALK ON
ITS OWN, BUT HOPEFULLY I CAN
SHARE THE ESSENTIALS IN A FEW
SLIDES.
THIS DIAGRAM SHOWS A VERY
SIMPLIFIED VERSION OF HOW AN
INVENTION MIGHT MOVE FROM AN
INITIAL DISCOVERY TO A LICENSE
AND BEYOND.
WHILE THE DEVELOPMENT PROCESS
AFTER THE TECHNOLOGY IS LICENSED
IS OF COURSE VERY IMPORTANT, WE
ARE ONLY FOCUSING ON THE GENERAL
PROCESS HERE AS IT PERTAINS TO
NIH.
IN FACT, THIS IS ESSENTIALLY THE
SAME PROCESS THAT ANY
ORGANIZATION MIGHT USE WHEN
PARTNERING WITH A COMPANY TO
DEVELOP THIS TECHNOLOGY,
ESPECIALLY EARLY STAGE
TECHNOLOGIES.
ONCE AN INVESTIGATOR MAKES
SOMETHING THEY THINK COULD BE AN
INVENTION, THEY REPORT TO THEIR
TECH TRANSFER CONTACT AND
INSTITUTE OR CENTER TECH
TRANSFER OFFICE.
THEY EVALUATE AND WORK WITH THE
INVESTIGATOR TO DETERMINE HOW
BEST TO DISSEMINATE IT, WHICH
COULD INCLUDE PATENT PROTECTION
WHEN NEEDED TO PROVIDE AN
INCENTIVE, BUT NOT ALWAYS.
THEN NIH SEEKS LICENSING
PARTNERS THROUGH A VARIETY OF
METHODS AND ONCE THEY FIND A
PARTNER OR HOPEFULLY PARTNERS,
THEY WORK TO NEGOTIATE A LICENSE
WITH THOSE PARTNERS FOLLOWING
THE PRINCIPLES THAT I HAD JUST
MENTIONED.
AND ONCE EXECUTED, THE COMPANY
STARTS DOWN THE ROAD OF
DEVELOPMENT AND
COMMERCIALIZATION AND NIH WILL
TRACK THEIR PROGRESS.
SO STEPPING BACK A LITTLE BIT TO
NEGOTIATING THE LICENSE, WHEN IT
COMES TO NEGOTIATING TERMS,
THERE SEEMS TO BE THE MOST
OUTSIDE INTEREST IN FINANCIALS,
ESPECIALLY THE ROYALTY RATE ON
PRODUCT SALES, AND THAT'S
UNDERSTANDABLE.
HOWEVER, FROM OUR PERSPECTIVE,
THE FINANCIALS ARE JUST ONE PART
OF THE PUZZLE, AND OFTEN IT'S
THE NON-FINANCIAL TERMS THAT
TAKE THE MOST TIME FOR US TO
NEGOTIATE.
DETERMINING THE SCOPE OF THE
LICENSE GRANT WHICH COULD
INCLUDE EXCLUSIVITY, THE
TERRITORY, WHAT IP IS INCLUDED,
STAGE OF DEVELOPMENT, WHAT
PRODUCTS THE LICENSEE WILL
COMMIT TO AND MORE AND ALSO A
PRENON-DEVELOPMENT TIMELINE AND
BENCHMARKS CAN BE COMPLICATED
ESPECIALLY WHEN IT COMES TO AN
EXCLUSIVE LICENSE.
SO CAN THINGS LIKE REPORTING.
ESPECIALLY WHEN IT COMES TO
THINGS LIKE PRODUCT SALES, AND
REQUIREMENTS ASSOCIATED WITH
SUBLICENSING AND OTHER
PARTNERSHIPS OUR LICENSEES MAY
WANT TO ENTER INTO.
THE NIH ALSO INCLUDES PUBLIC
BENEFIT OR WHITE KNIGHT
PROVISIONS TO ENCOURAGE THE
LICENSEE TO FACILITATE ACCESS,
EDUCATION AND FURTHER RESEARCH.
THESE CAN BE A VARIETY OF THINGS
LIKE PROVIDING PATIENT EDUCATION
OR SUPPLYING PRODUCT FOR FURTHER
RESEARCH.
AND THEN I'M GOING TO COME BACK
NOW TO MONITORING LICENSING
PROGRESS.
THIS IS A CRITICAL PART OF OUR
BENEFIT TO -- WE DON'T KNOW IF
OUR LICENSEES ARE ACTUALLY
DEVELOPING THE TECHNOLOGIES,
WE'RE NOT BEING GOOD STEWARTS OF
OUR RESPONSIBILITIES.
SO A LITTLE BIT MORE ABOUT THAT
HERE.
AS I'VE ALLUDED, IT'S A START OF
A MULTIYEAR RELATIONSHIP BETWEEN
NIH AND THE LICENSEE.
THIS IS ONE PARTICULARLY FOR
EARLY STAGE TECHNOLOGIES THAT
CAN LAST 10 OR 15 YEARS OR EVEN
LONGER.
THERE ARE A LOT OF UNKNOWNS AND
AT NIH WE CAN'T ASSUME ONCE THE
BALL STARTS ROLLING IT WILL MAKE
IT SUCCESS THRI DOWN THE ROAD TO
THE DESTINATION AND THE PRODUCT
THAT WE ARE HOPING TO SEE.
THAT'S AN IMPORTANT REASON WHY
WE REQUIRE A DEVELOPMENT PLAN,
BENCHMARKS AND REPORTING BY THE
LICENSEE SO THAT WE CAN SEE
WHETHER THE LICENSEE IS ON TRACK
OR NOT, AND WHETHER THAT'S DUE
TO A LACK OF DILIGENCE ON THE
LICENSEE'S PART OR FROM OTHER
FACTORS THAT MAY BE OUTSIDE THE
LICENSEE'S CONTROL.
FINDING POTENTIAL PROBLEMS EARLY
MEANS THEY'RE EASIER TO RESOLVE,
AND WE DO WORK WITH OUR
LICENSEES TO RESOLVE PROBLEMS IF
WE CAN.
WE ACTUALLY HAVE AN ENTIRE GROUP
AT THE NIH OFFICE OF TECHNOLOGY
TRANSFER THAT'S DEDICATED TO
REVIEWING EXECUTED LICENSES TO
MAKE SURE THAT OUR LICENSEES ARE
COMPLIANT WITH THEIR TERMS AND
MAKING GOOD PROGRESS.
OUR SPECIALISTS EXAMINE PROGRESS
REPORTS, BENCHMARKS, PAYMENT
HISTORY, PUBLISHED INFORMATION,
OTHER PUBLIC INFORMATION
PROVIDED BY THE LICENSEE, AS
WELL AS DISCUSSING PROGRESS WITH
THE LICENSEE.
IF THE LICENSEE IS NOT
PERFORMING, WE HAVE A NUMBER OF
LEVERS THAT WE CAN USE.
BUT ALWAYS FOCUSING ON OUR END
GOAL, WHICH IS WHAT'S BEST FOR
GETTING OUR TECHNOLOGIES OUT TO
BENEFIT THE PUBLIC.
WITH THAT, I'M GOING TO TURN THE
DISCUSSION OVER TO MY COLLEAGUE,
ABBY RIVES, NOW THAT HOPEFULLY
THERE'S SOME BACKGROUND AND
CONTEXT ABOUT OUR IRP LICENSING
PROGRAM, WILL TALK ABOUT THE
PROPOSED POLICY.
OVER TO YOU, ABBY.
>> THANKS VERY MUCH, TARA.
I'LL JUST REITERATE WHAT LYRIC
AND TARA HAVE ALREADY SAID,
THANKS TO ALL OF YOU WHO ARE
JOINING THIS WEBINAR.
WE'RE GRATEFUL FOR YOUR INTEREST
IN THIS TOPIC AND LOOK FORWARD
TO HEARING FROM YOU IN THE
FUTURE.
SO I AM GOING TO TALK ABOUT THE
REQUEST FOR INFORMATION THAT NIH
PUBLISHED LATE LAST MONTH, BUT
BEFORE WE DIVE INTO THOSE
DETAILS, WE THOUGHT IT MIGHT
HELP TO UNPACK WHAT PEOPLE MEAN
WHEN THEY TALK ABOUT ACCESS
PLANNING.
AND I USE THIS SIMPLISTIC
DIAGRAM TO HELP ILLUSTRATE THAT
IDEA.
SO THE BASIC IDEA OF ACCESS
PLANNING INVOLVES INCORPORATING
PATIENT ACCESS CONSIDERATIONS AT
A HIGH LEVEL IN' AGREEMENTS
RELATED TO BIOMEDICAL RESEARCH
AND DEVELOPMENT.
A PATENT LICENSE HERE AT THIS
POINT IN TIME DURING THE
PRE-CLINICAL STAGE OF
DEVELOPMENT OR EVEN EARLIER
MIGHT REQUIRE A LICENSEE TO
SUBMIT A PATIENT ACCESS PLAN IF
AND WHEN THE LICENSEE GET TO A
CERTAIN LATER POINT IN PRODUCT
DEVELOPMENT.
THE INITIAL LICENSE WOULD NOT
INCLUDE ALL THE DETAILS ABOUT
HOW THE LICENSEE WILL PROMOTE
ACCESS.
INSTEAD, THOSE AGREEMENTS -- IN
THOSE AGREEMENTS, THE PARTIES
WILL COMMIT TO REVISITING ACCESS
SO THE INITIAL AGREEMENT TERMS
WOULD BE INTENTIONALLY FLEXIBLE
AND NOT PRESCRIPTIVE, AND IF
PRODUCT DEVELOPMENT IS
SUCCESSFUL, THEN AND ONLY THEN
WOULD A LICENSEE DEVELOP AND
SUBMIT THEIR ACCESS PLAN.
THAT LATER PLAN WOULD INCLUDE
MORE OF THE DETAILED
CONSIDERATIONS AROUND PROMOTING
ACCESS.
THIS ALSO ALLOWS ACCESS PLANNING
WORK DONE IN COORDINATION
BETWEEN THE PARTIES BETWEEN THE
PATENT OWNER AND THE LICENSEE,
AND YOU COULD ANALOGIZE THIS
APPROACH TO ACCESS PLANNING TO
SOME OF THE COMMERCIAL
DEVELOPMENT PLANNING THAT TARA
JUST SPOKE ABOUT ELSEWHERE IN
BIOMEDICAL R & D LICENSES.
THIS ISN'T AN ENTIRELY NEW IDEA,
SIMILAR VERSIONS OF ACCESS
PLANNING ALREADY AND DIFFERENT
INSTITUTIONS ARE TAKING
DIFFERENT APPROACHES.
IF YOU'RE INTERESTED IN STARTING
TO LEARN A LITTLE BIT MORE, THIS
IS A TOPIC THAT WAS DISCUSSED
DURING AN NIH WORKSHOP LAST
JULY, AND THE REPORT HERE ON THE
NIH OSP WEBSITE ALONG WITH A
WEBCAST OF THAT WORKSHOP ARE
AVAILABLE ONLINE, SUMMARIZING IN
PART THE BASIC IDEA AND
INCLUDING SOME LINKS TO SOME
RELEVANT BACKGROUND MATERIALS
AND PERSPECTIVES FROM SOME OTHER
FOLKS ON THIS TOPIC.
SO WITH THAT CONTEXT IN PLACE,
AS YOU ALL KNOW, LATE LAST
MONTH, NIH RELEASED THIS INITIAL
POLICY PROPOSAL DRAFT AND A
REQUEST FOR INFORMATION ABOUT
INCORPORATING PATIENT ACCESS
PLANNING INTO OUR INTRAMURAL
PROGRAM'S PATENT LICENSES.
AS LYRIC MENTIONED, WE'RE HERE
AT THE RFI STAGE.
WE AS AN AGENCY ARE VERY EAGER
TO HEAR PERSPECTIVES FROM THE
PUBLIC ON THIS DRAFT POLICY AND
WE'RE INTERESTED IN YOUR
FEEDBACK ON THE QUESTIONS POSED
IN THE RFI.
SO TURNING TO WHAT IS IN THAT
RFI, AND OUR GOAL HERE WAS
PROVIDING THIS INFORMATION AS TO
HOPEFULLY FACILITATE YOUR
PARTICIPATION IN THE PROCESS, SO
THIS IS A HIGH LEVEL SUMMARY OF
WHAT'S PROPOSED IN THE DRAFT
POLICY AND RFI.
WE WOULD DEVELOP THROUGH OUR
INTRAMURAL PATENT LICENSING
PROGRAM A NEW POLICY TO PROMOTE
ACCESS TO PRODUCTS THAT STEM
FROM OUR IRP NIH-OWNED
INVENTIONS.
IT WOULD INVOLVE INCORPORATING
EXPLICIT PATIENT ACCESS PLANNING
EARLIER IN THE COMMERCIALIZATION
PROCESS, AND IT WOULD INVOLVE
THE AGENCY WORKING WITH OUR
PATENT LICENSEE ON OUR SHARED
PUBLIC HEALTH GOALS.
PRACTICALLY SPEAKING, WHAT WE
ARE PROPOSING AND WHAT IT WOULD
LOOK LIKE WOULD BE ADDING NEW
LANGUAGE TO SOME OF OUR MODEL
PATENT LICENSE AGREEMENTS.
THOSE MODEL AGREEMENTS ARE
POSTED ALREADY ON THE NIH
TECHNOLOGY TRANSFER COMMUNITY
WEBSITE, AND THEY SERVE AS THE
BASIS FOR LICENSE NEGOTIATIONS,
SO I'LL TURN TO WHAT SPECIFICS
OF THIS MIGHT LOOK LIKE IN A
SECOND IN THE NUTS AND BOLTS OF
THE DRAFT PROPOSED POLICY.
SO STARTING WITH THE SCOPE, THE
PROPOSED POLICY SCOPE IS
RELATIVELY STRAIGHTFORWARD.
ENCOMPASSED IN THE RFI, THIS
WOULD BE A POLICY THAT WOULD
APPLY TO LICENSES, AGAIN, THAT
ORIGINATE FROM THE NIH
INTRAMURAL PROGRAM.
IT WOULD APPLY TO COMMERCIAL
THAT TENT LICENSES AND MORE
SPECIFICALLY TO THOSE LICENSES
THAT AUTHORIZE COMMERCIALIZATION
OF DRUG BIOLOGICS, VACCINES OR
DEVICES IN CONTRAST TO, FOR
EXAMPLE, WHAT TARA MENTIONED,
LICENSES THAT WOULD AUTHORIZE
USE OF CERTAIN RESEARCH TOOLS.
AND THE POLICY WOULD APPLY TO
LICENSES THAT SPAN NON-EXCLUSIVE
TO EXCLUSIVE.
A NOTE THAT WE ARE IT BE I CONTO
EXPLORE WHETHER AND HOW THIS
POLICY MIGHT APPLY TO JOINTLY
OWNED INVENTIONS, SO APPLICATION
OF THE PROPOSED POLICY TO
PATENTS THAT ARE JOINTLY OWNED
BY NIH WILL BE CONSIDERED AT A
LATER DATE, AND THIS POLICY
WOULD NOT REACH THE I.P. THAT
OUR LICENSEES DEVELOP ON THEIR
OWN OR I.P. THAT OUR PARTNERS
BRING INTO COLLABORATION.
PUT ANOTHER WAY, PATENTS OWNED
SOLELY BY NIH'S COLLABORATORS
AND PARTNERS WOULD BE OUTSIDE
THE SCOPE OF THIS POLICY.
HERE IS THE DRAFT LANGUAGE FROM
THE RFI, AND AS I MENTIONED, NIH
WOULD ADD LANGUAGE LIKE THIS TO
THE MODEL AGREEMENTS THAT ARE
WITHIN THE SCOPE OF THE POLICY.
I'M NOT GOING TO BORE YOU WITH
ALL THE DETAILS HERE, BUT I DID
WANT TO HIGHLIGHT JUST A FEW
PIECES THAT YOU CAN GLEAN FROM
THIS LANGUAGE.
WITH THIS LANGUAGE, NIH WOULD
ASK OUR LICENSEES TO SEND US
ACCESS PLAN.
THE ACCESS PLAN WOULD ADDRESS
STRATEGIES TO SUPPORT PATIENT
ACCESS BROADLY IN THE UNITED
STATES, AND WE CALL OUT A FOCUS
ON UNDERSERVED DOMESTIC AND/OR
GLOBAL POPULATIONS AS WELL.
THAT ACCESS PLAN WOULDN'T BE DUE
UNTIL THE LICENSEE HAS A PRODUCT
IN PIVOTAL CLINICAL TRIAL, PHASE
THREE OR THE EQUIVALENT.
THIS LANGUAGE ALSO DEFINES WHAT
AN ACCESS PLAN IS.
AND THE LANGUAGE ENVISIONS
FLEXIBILITY.
IT ENVISIONS OPPORTUNITIES FOR
NIH TO WORK WITH OUR LICENSEES
AND THAT COULD INVOLVE NIH
WORKING WITH OUR LICENSEES TO
CONFER ABOUT WHAT GOES INTO AN
ACCESS PLAN.
THIS LANGUAGE ALSO INCLUDES A
PROVISION FOR LICENSEES TO SEEK
WAIVERS.
WE ANTICIPATE THAT THESE
PROCESSES COULD MIRROR THE WAY
NIH ALREADY WORKS WITH OUR
LICENSEES ON OTHER REQUIREMENTS
TARA MENTIONED LIKE DEVELOPMENT
MILESTONES, PROGRESS REPORTS AND
OTHER LICENSING REQUIREMENTS.
BEFORE WE FINALIZE ANY ACCESS
PLANNING POLICY, NIH PROPOSES TO
DEVELOP GUIDANCE FOR ACCESS
PLANS.
THIS COULD INCLUDE AN ACCESS
PLAN TEMPLATE THIS OUR LICENSEES
COULD FILL OUT.
DRAWING FROM LANGUAGE ON THE
PREVIOUS SLIDE AND THE MODEL
LANGUAGE OF THE -- THE DRAFT
LANGUAGE FOR MODEL AGREEMENTS,
HERE ARE THE LIST OF THINGS
WE'RE PROPOSING FOR EVERY ACCESS
PLAN TO INCLUDE.
FIRST A DESCRIPTION OF THE
PRODUCT, IDENTIFICATION OF THE
ANTICIPATED PATIENT POPULATION,
THE THIRD BULLET POINT ABOUT
OTHER PRODUCTS, TOOLS,
FACILITIES OR UNIQUE RESOURCES
NECESSARY TO USE A PRODUCT.
WE'VE INCLUDED THIS IN
RECOGNITION OF THE FACT THAT A
LOT OF FEATURES OF ACCESS ARE
OUTSIDE THE LICENSEES' CONTROL.
FOR EXAMPLE, OUR ACCESS TO A
GIVEN PRODUCT MIGHT HINGE ON
OTHER HEALTHCARE INFRASTRUCTURE,
OR A PATIENT MIGHT NEED ACCESS
TO A CERTAIN DIAGNOSIS BEFORE
RECEIVING A TREATMENT, BUT
ACCESS TO THAT DIAGNOSTIC MIGHT
BE OUTSIDE OF THE LICENSEE'S
CONTROL.
LICENSEES COULD NOTE SOME OF
THESE OTHER FEATURES IN AN
ACCESS PLAN BECAUSE WE RECOGNIZE
THAT THERE MAY BE EXTERNAL
CHALLENGES TO PATIENT ACCESS,
AND WE CAN FACTOR THOSE INTO OUR
CONVERSATION HERE.
WE ALSO THINK THAT EXPLORING
THESE OTHER FEATURES THAT IMPACT
ACCESS AND HAVING THESE
CONVERSATIONS AT THE AGENCY CAN
ALLOW NIH AND OUR PARTNERS
ACROSS THE BOARD TO APPROACH
THINKING ABOUT ACCESS FROM
UNIQUE ANGLES AS WELL.
FOR EXAMPLE, WE CAN ALSO BE
THINKING ABOUT PRODUCT DESIGN
CHOICES, DIRECTIONS FOR FUTURE
R & D, OR FUTURE
COMMERCIALIZATION OPPORTUNITIES
TO DEVELOP PRODUCTS THAT MEET
MORE PATIENTS WHERE THEY ARE AT.
RELATEDLY AS PART OF THE RFI AND
THE DRAFT PROPOSED ACCESS
PLANNING POLICY, WE ARE
INTERESTED IN HEARING INPUT ON
WHAT NIH AND THE GOVERNMENT CAN
DO TO HELP OUR LICENSEES ACHIEVE
ACCESS GOALS.
THERE MAY BE EXISTING PROGRAMS
WE CAN PLUG INTO TO MITIGATE
EXTERNAL ACCESS CHALLENGES.
AND THEN FINALLY, ACCESS PLANS
WOULD CONTAIN ONE OR MORE
STRATEGIES TO MITIGATE THOSE
ACCESS CHALLENGES.
AS PAR OF THE ACCESS PLANNING
GUIDANCE NIH IS PROPOSING, WE
WOULD ALSO INCLUDE A LIST OF
IDEAS OR MANY EXAMPLES, IF YOU
WILL, OF STRATEGIES THAT
LICENSEES CAN SELECT TO INCREASE
EQUITABLE ACCESS.
AT THE RFI STAGE, THIS IS
CERTAINLY ONE OF THE AREAS THAT
WE'VE REALLY CALLED OUT FOR
PUBLIC INPUT.
WE'RE EAGER TO HEAR YOUR IDEAS
ABOUT STRATEGIES TO EXPAND THE
REACH AND THE BENEFIT OF NEW
BIOMEDICAL PRODUCTS.
THE PERSPECTIVES THAT YOU SHARE
COULD HELP SHAPE THIS INTO A
MORE COMPREHENSIVE AND CONCRETE
LIST, AND THIS IS A TOPIC THAT
NIH CAN ALSO CONTINUE TO REVISIT
AS NEW IDEAS AND STRATEGIES
EMERGE OVER THE COMING YEARS.
AMONG THE IDEAS WE INCLUDED IN
THE RFI, THE FIRST ONE LISTED
HERE, PARTNERING WITH PUBLIC
HEALTH, NON-PROFIT OR PATIENT
ADVOCACY ORGANIZATIONS, EXAMPLES
OF THIS MIGHT INCLUDE
PARTNERSHIPS DURING RESEARCH AND
DEVELOPMENT, PARTNERSHIPS DURING
REGULATORY APPROVAL, OR THE
POINT OF SALES AND MARKETING.
IT COULD INCLUDE SELLING
LICENSED PRODUCTS TO PARTNER
ORGANIZATIONS THAT TREAT
UNDERSERVED POPULATIONS.
OR IT MIGHT INVOLVE PARTNERING
TO LICENSE INTELLECTUAL PROPERTY
TO PUBLIC HEALTH PATENT POOLS.
AGAIN, THOSE ARE JUST SOME
EXAMPLES OR IDEAS THAT COULD
FALL UNDER THIS FIRST PROPOSED
POTENTIAL STRATEGY FOR EXPANDING
REACH AND BENEFIT OF PRODUCT.
THE SECOND BULLET HERE
ADDRESSING ACCESSIBILITY AS A
DESIGN OBJECTIVE.
EXAMPLES COULD INCLUDE
CONDUCTING PATIENT INTERVIEWS OR
NEED ASSESSMENT EARLY IN PRODUCT
DEVELOPMENT FOR STRATEGICALLY
MAKING CHOICES ORIENTED TOWARDS
PROMOTING PATIENT ACCESS.
THIRD ON THIS LIST, COMMITTING
TO SUBLICENSE RELEVANT
INTELLECTUAL PROPERTY AND
KNOW-HOW.
SOME OF THE EXAMPLES WE
MENTIONED IN THE RFI HERE COULD
INCLUDE SUBLICENSING TO
MANUFACTURERS OP VOLUNTARY AND
MUTUALLY AGREED TO TERMS, OR
COMMITTING TO LICENSE ALL THE IP
NEEDED TO MAKE A PRODUCT IF THE
LICENSEE LATER DECIDES TO EXIT
THE MARKET.
NEXT ON THIS LIST, PARTNERING
PARTNERSHIPS FOR COMMITMENT.
EXAMPLES HERE MIGHT INCLUDE
SOMETHING LIKE COMMITTING TO
SUPPLY PRODUCT IN A GIVEN MARKET
OR MARKETS FOR A DESIGNATED
DURATION, OR IT COULD INCLUDE
AGREEING TO COORDINATE AND SET
ASIDE A PORTION OF THE LICENSED
PRODUCT ONCE IT'S BEEN
MANUFACTURED, COORDINATION OR
SALE TO A PARTNER ORGANIZATION
ON A COST-PLUS BASIS.
NEXT, SUBMITTING ADDITIONAL
COMMERCIALIZATION PLANS TARGETED
TO OTHER MARKETS.
ONE EXAMPLE COULD INCLUDE A
FOLLOW-UP PRODUCT DEVELOPMENT
TIMELINE AND PLAN TO DEVELOP A
NEW FORMULATION OF A PRODUCT
THAT WOULD BE TAILORED TO
MEETING A POPULATION'S UNIQUE
NEED.
FOR EXAMPLE IF THE LICENSEE
INITIALLY BRINGS A FORMULATION
OF A PRODUCT TO MARKET AND THAT
DOESN'T MEET EVERY PATIENT'S
NEEDS, THEY COULD FOLLOW ON WITH
ADDITIONAL COMMERCIAL
DEVELOPMENT PLANS TO EXPAND THE
REACH TO FURTHER PATIENTS AND
COMMUNITIES.
THEN NEXT ON THE LIST, PROMOTING
EQUITABLE ACCESS AND
AFFORDABILITY IN PRODUCT
DEVELOPMENT AND DEPLOYMENT.
EXAMPLES MENTIONED HERE COULD
INCLUDE THINGS LIKE COMMITTING
TO KEEP PRICES IN THE UNITED
STATES EQUAL TO THOSE IN OTHER
DEVELOPED COUNTRIES, NOT RAISING
PRODUCT COSTS AND PRICES ABOVE
THE RATE OF INFLATION, OR
PREPARING TAILORED CULTURALLY
SENSITIVE EDUCATIONAL MATERIALS
FOR A RANGE OF PATIENT
POPULATIONS ACROSS THE COUNTRY
AND THE GLOBE.
I ALSO WANT TO NOTE THE LAST
BULLET POINT HERE.
WE WANT TO INVITE OUR LICENSEES
TO LET US KNOW IF THERE ARE
THINGS WE, NIH AND THE UNITED
STATES GOVERNMENT, COULD BE
DOING TO HELP THEM MEET THEIR
ACCESS GOALS.
THIS MIGHT INVOLVE, FOR EXAMPLE,
CONNECTING LICENSEES WITH
EXISTING NIH OR OTHER U.S.
GOVERNMENT PROGRAMS OR
RESOURCES, MERELY BY WAY OF
EXAMPLE, WE AT NIH HAVE PROGRAMS
TO SUPPORT PRE-CLINICAL
DEVELOPMENT WORK, AND PROGRAMS
THAT ALLOW US TO SHARE SOME
IN-HOUSE PRODUCT DEVELOPMENT
EXPERTISE.
SO AGAIN, AS PART OF THE ACCESS
PLANNING PROPOSAL BUT ALSO AS
PART OF THE RFI, WE'RE
INTERESTED IN HEARING REACTIONS,
REFLECTIONS FROM THE PUBLIC AND
FROM VARIOUS INTERESTED
COMMUNITIES ABOUT THINGS THAT WE
CAN BE DOING TO ADVANCE OUR
SHARED ACCESS GOALS.
I ALSO WANT TO NOTE IN THE RFI
WHEN WE DEFINE ACCESS, WE'VE
TRIED TO TAKE A BROAD LENS.
WE RECOGNIZE THERE ARE MYRIAD
FACTORS THAT AFFECT ACCESS TO
EMERGING BIOMEDICAL
TECHNOLOGIES.
THAT INCLUDE FACTORS SUCH AS
AFFORDABILITY, PATIENTS CANNOT
GET THE BENEFIT OF PRODUCTS THEY
CANNOT AFFORD.
AVAILABILITY, IF A PRODUCT DOES
NOT EXIST, IF A PRODUCT IS NOT
BEING MANUFACTURED OR SUPPLIED
IN A GIVEN REGION.
IT'IF THE REGULATORY AUTHORITIES
HAVE NOT APPROVED THE PRODUCT,
THEN THAT PRODUCT CANNOT DELIVER
VALUE TO PATIENTS.
ACCEPTABILITY, FOR EXAMPLE, WILL
THE PRODUCT RESONATE WITH END
USERS, WILL THEY BE WILLING AND
ABLE TO USE THE PRODUCT?
AND FINALLY, SUSTAINABILITY.
PART OF THAT IS A RECOGNITION
THAT WHAT IS ACCESSIBLE TODAY
MAY NOT BE ACCESSIBLE SEVERAL
YEARS FROM NOW BUT PATIENTS
MIGHT NEED OR WANT A PRODUCT
SEVERAL YEARS FROM NOW.
SO WITH THE RFI, WE'VE INVITED
LICENSEES TO WORK ALONG ANY OR
MULTIPLE OF THESE AK SEES TO
DELIVER -- WHEN WE RECOGNIZED IT
MIGHT NOT MAKE SENSE FOR AN
ADDRESSEE TO ADDRESS ALL OF
THESE, THE IDEA WITH THE DRAFT
PROPOSAL AT THIS POINT, AT
LEAST, WOULD BE TO HAVE
LICENSEES CONSIDER THOSE THAT
FIT THEIR PRODUCT AND MARKET AND
THAT FIT THEIR PATIENT
POPULATION BEST.
FINALLY THE DRAFT PROPOSED
POLICY WOULD ACCOUNT FOR THE
STAGE OF TECHNOLOGY DEVELOPMENT.
MOST OF NIH'S LICENSES ARE EARLY
STAGE AND FOR THOSE LICENSES,
THE STRUCTURE HERE IS THE ONE I
JUST DESCRIBED.
IN THE INSTANCES WHERE NIH
ADVANCES TECHNOLOGY PRETTY FAR
ALONG, AT THAT POINT, WE ALREADY
KNOW MORE ABOUT THE PRODUCT, WE
HAVE A BETTER SENSE OF WHO THE
PATIENTS WILL BE, AND WE WILL
HAVE A BETTER SENSE OF WHAT
MECHANISMS MIGHT BE AVAILABLE TO
IMPROVE PATIENT ACCESS.
IN THOSE CIRCUMSTANCES, WE'RE
EXPLORING ADDING DIFFERENT
SPECIFICS TO THOSE LICENSES,
TAILORED ACCESS ORIENTED
PROVISIONS FOR THESE LATE STAGE
LICENSES, AND THAT'S A DETAIL
WE'RE ALSO ACTIVELY EXPLORING
INCLUDING THROUGH THIS RFI.
SO THAT'S THE PROPOSAL.
AGAIN, WE'RE INVITING PUBLIC
INPUT ON EVERYTHING I JUST
SHARED.
IN ADDITION TO THOSE ASPECTS OF
A DRAFT PROPOSED POLICY, WE HAVE
A HANDFUL OF QUESTIONS THAT WE
ALSO INCLUDED IN THE RFI WHERE
WE'RE ALSO INTERESTED IN HEARING
IDEAS FROM THE COMMUNITY.
THE FIRST OF THOSE QUESTIONS IS
FOCUSED ON IDEAS ABOUT
STRATEGIES FOR IMPROVING ACCESS.
FOR EXAMPLE, IF YOU HAVE
EXPERIENCE WITH COMMERCIALLY
REASONABLE APPROACHES TO PROMOTE
PATIENT ACCESS IN THESE OR OTHER
CIRCUMSTANCES, WE WOULD LOVE TO
HEAR THAT FEEDBACK.
WE HAVE A QUESTION ABOUT
PROMOTING TRANSPARENCY IN THE
BIOMEDICAL RESEARCH ENTERPRISE
AND RETURN ON INVESTMENT.
THAT'S WITH AN EYE TOWARD,AGE
OTHER THINGS, DRIVING DOWN COSTS
ASSOCIATED WITH INNOVATION,
MAKING CLEAR WHAT COSTS ARE
INCURRED ALONG THE WAY, AND
MAKING CLEAR HOW THOSE COSTS
AFFECT PRODUCT COSTS.
UNDER THE THIRD QUESTION ABOUT
PROVIDING FLEXIBILITY WHILE
ACHIEVING CLEAR POLICY
OBJECTIVES, WE REALIZE THAT
INCLUDES EVERYONE, NIH, OUR
LICENSEES, OUR LICENSEES'
PARTNERS AND THE PUBLIC NEED
CONFIDENCE AROUND WHAT THIS
POLICY WOULD REQUIRE.
LIKEWISE, THERE'S A NEED FOR
CLARITY AND CERTAINTY AROUND THE
STANDARDS THAT WOULD BE USED TO
EVALUATE ACCESS PLANS FOR
WAIVERS, SO WE'RE SEEKING INPUT
ON THOSE ASPECTS OF THE POLICY
LOOKING TO ALLOW FLEXIBILITY FOR
LICENSEES TO PURSUE SPECIFIC
PRODUCT DEVELOPMENT NEEDS WHILE
SIMULTANEOUSLY PROMOTING
CERTAINTY AND TRANSPARENCY.
AS I MENTIONED, WE WANT TO HEAR
IDEAS ABOUT HOW NIH CAN HELP
LICENSEES DELIVER PATIENT ACCESS
TO PRODUCT THAT STEM FROM THESE
IRP PATENT LICENSING AGREEMENTS.
WE HAVE A QUESTION ABOUT
ESTABLISHING LICENSEE
OBLIGATIONS DEPENDING ON THE
STAGE OF A TECHNOLOGY'S
DEVELOPMENT.
AND THE FINAL QUESTION IN THE
RFI IS FOCUSED ON ASSESSING
POLICY IMPACT.
WHAT METRICS COULD THE AGENCY
USE IN THE NEAR TERM AND THE
LONG TERM AND ACCESS PLANNING
POLICY.
SO BEFORE WE TURN TO A FEW
QUESTIONS, I JUST WANTED TO
OFFER A FEW KEY LINKS.
AS A REMINDER, THE REQUEST FOR
INFORMATION THAT WE'RE TALKING
ABOUT TODAY IS OPEN UNTIL
JULY 22ND, AND WE INVITE ANYONE
WHO IS INTERESTED TO SHARE THEIR
FEEDBACK ON OR BEFORE THAT DATE.
HERE'S A LINK TO THE FEDERAL
REGISTER PAGE WHERE YOU CAN FIND
ALL THE DETAILS WE JUST
PRESENTED.
AND THERE'S A COMMENT FORM ON
THE NIH OFFICE OF SCIENCE POLICY
WEBSITE WHERE YOU CAN SUBMIT
YOUR FEEDBACK, AND THEY ALSO MAY
BE INTERESTED IN THIS LINK TO
THE NIH TECHNOLOGY TRANSFER
COMMUNITY WE CAN S WEBSITE AND H
SCIENCE POLICY WEBSITE.
SO WITH THAT, WE ARE GOING TO --
I'LL ASK TARA TO JOIN ME AND
WE'LL TALK ABOUT SOME OF THE
QUESTIONS THAT WERE SUBMITTED IN
ADVANCE.
SO THE FIRST ONE I'LL START
WITH, WHO SHOULD RESPOND TO THE
RFI?
I'VE GOT SOME THOUGHTS ON THAT,
CERTAINLY I INVITE TARA TO CHIME
IN, BUT OVERALL, OUR AIM IN
RELEASING THIS RFI IS TO BE ABLE
TO SOLICIT REALLY ROBUST, BROAD
AND ENCOMPASSING STAKEHOLDER
FEEDBACK ON THIS DRAFT PROPOSED
POLICY, SO WE'RE WELCOMING
FEEDBACK FROM ALL TYPES OF
RESPONDENTS THAT WOULD INCLUDE
PATIENTS AND PATIENT ADVOCATES,
SMALL BUSINESSES AND STARTUPS,
TECHNOLOGY TRANSFER AND
LICENSING PROFESSIONALS,
INCLUDING FOLKS WITH EXPERIENCE
NEGOTIATING THESE TYPES OF
AGREEMENTS FOR EARLY STAGE
BIOMEDICAL PATENTS AND
NEGOTIATING THESE TYPES OF
TERMS, ACCESS PLANS OR OTHER
SIMILAR PROVISIONS.
WE WOULD WELCOME INPUT FROM
INVESTORS, INDUSTRY PARTNERS,
HEALTHCARE PROVIDERS,
UNIVERSITIES, OTHER PUBLIC
INTEREST GROUPS.
THE LIST GOES ON.
TARA, ARE THERE ANY CATEGORIES
YOU THINK I'VE MISSED?
>> I DON'T KNOW OF ANY, BUT
PLEASE, IF YOU ARE NOT MENTIONED
AND YOU HAVE INPUT, PLEASE
PROVIDE IT, BECAUSE WE WANT TO
HEAR FROM EVERYONE.
WE DON'T WANT TO OPERATE IN A
VACUUM.
OUR STAKEHOLDER INPUT WHICH
INCLUDES ALL THESE GROUPS AND
MORE IS CRITICAL TO US FORMING A
GOOD AND USEFUL POLICY THAT WE
THINK WILL BENEFIT NOT JUST NIH
BUT THE PUBLIC WHEN OUR PRODUCTS
COME TO MARKET.
>> YEAH, MAYBE IT GOES WITHOUT
SAYING, BUT THE RESPONSES THAT
WE RECEIVED FOR THE RFI ARE
GOING TO REALLY INFORM THE
AGENCY'S DEVELOPMENT OF NIL
FINAL POLICY, AND SO AS WE SAID
AT THE OUTSET, WE TAKE THIS PART
OF OUR JOB VERY SERIOUSLY AND
LOOK FORWARD TO HEARING FROM
YOU.
OKAY.
SO THE NEXT QUESTION I HAVE, AND
IT'S A LITTLE BIT OF A TWO
PARTER, WILL NIH ACCEPT ACCESS
PLAN THAT DON'T SUPPORT GLOBAL
ACCESS?
WE NOTE THE POLICY WOULD REQUIRE
PLANS SUPPORTING ACCESS FOR
UNDERSERVED U.S. AND/OR LMIC
POPULATION.
FOR THE CASES IN WHICH GLOBAL
ACCESS COMMITMENTS ARE
APPROPRIATE, WHERE THE LICENSEE
DOES NOT INCLUDE THEM IN THE
EQUITABLE ACCESS PLAN, HOW DOES
NIH INTEND TO ADVANCE GLOBAL
ACCESS PROVISION?
I WILL AT THE START RESPOND BY
REITERATING THAT THIS IS AN RFI.
OUR EARS ARE OPEN SO WE'RE
DEFINITELY INTERESTED IN HEARING
THOUGHTS FROM THE PUBLIC ON THAT
POINT.
ALSO JUST TO DOUBLE DOWN ON
SOMETHING WE'VE ALREADY
MENTIONED, WE'RE INTERESTED IN
SUGGESTIONS AND IDEAS FROM THE
PUBLIC ON COMMERCIALLY
REASONABLE STRATEGIES TO ADVANCE
BOTH DOMESTIC PUBLIC HEALTH AND
GLOBAL ACCESS GOALS.
ANOTHER PIECE OF THIS, AND I'LL
INVITE TARA TO CHIME IN,IS THAT
WE RECOGNIZE NO TWO NIH LICENSES
ARE THE SAME, THERE'S A LOT AT
PLAY WHEN IT COMES TO THE
COMMERCIALIZATION OF ANY
TECHNOLOGY.
THE SITUATION IS A VERY CASE TO
CASE, PATIENT TO PATIENT,
PRODUCT TO PRODUCT, LICENSEE TO
LICENSEE, SO WE DO WANT TO MAKE
SURE THAT WE'RE CHARTING A
POLICY THAT IS FLEXIBLE ENOUGH
TO REALLY ACCOMMODATE THAT RANGE
AND GIVES THE AGENCY FLEXIBILITY
TO WORK WITH OUR LICENSEES TO
MAKE SURE WE'RE DOING OUR LEVEL
BEST TO IMPROVE ACCESS.
I'LL STOP RAMBLING AND SEE IF
YOU HAVE SOME THOUGHTS.
I THINK I HAVE A COUPLE OTHERS,
THOUGH.
>> SURE.
I MEAN, I THINK THIS IS EXACTLY
UP WITH OF THE REASONS WHY WE
ARE COMING OUT WITH THIS RFI
BECAUSE WE ARE LOOKING FOR
IDEAS.
HOW COULD WE ADVANCE GLOBAL
ACCESS IF OUR LICENSEE IS NOT
ABLE TO AND IT SEEMS LIKE IT
WOULD BE APPROPRIATE IN THAT
CASE.
SO YES, DEFINITELY INPUT WOULD
BE VERY IMPORTANT, BUT AGAIN I
THINK WE STRESSED ALL ALONG THAT
WE WORK WITH OUR LICENSEES TO
FIND SOLUTIONS, WE DON'T WANT TO
PUNISH A COMPANY FOR NOT
PURSUING A SPECIFIC AVENUE, SO
MAYBE WE CAN FIND OTHER WAYS TO
ACHIEVE THAT GOAL, AND IT COULD
BE TAILORING THE LICENSE,
ENCOURAGING PARTNERSHIPS WITH
OTHER ORGANIZATIONS.
THERE ARE A LOT OF DIFFERENT
POSSIBILITIES AND WE WANT TO
HEAR FROM YOU ABOUT THINGS THAT
WE MAY NOT HAVE THOUGHT ABOUT.
WE CERTAINLY HAVE A LOT OF
EXPERIENCE WITH GENERAL
BIOMEDICAL PRODUCT DEVELOPMENT
WITH OUR LICENSES, BUT WE ARE
NOW FOCUSING MORE SPECIFICALLY
ON ACCESS, AND THAT'S WHERE WE
CAN USE YOUR INSIGHTS.
>> AND RECOGNIZING THAT NO TWO
LICENSES ARE THE SAME, THE
ACCESS STRATEGIES THAT WERE
GOING TO NEED TO PURSUE AT ANY
GIVEN TIME ARE GOING TO VARY
FROM PRODUCT TO PRODUCT, LICENSE
TO LICENSE.
AT SOME POINT PATIENT TO PATIENT
OR PAISH COMMUNI PATIENT COMMUNT
COMMUNITY SO WE'RE GOING TO NEED
A LOT OF IDEAS ON THE TABLE AND
THE FLEXIBILITY TO WORK TOWARDS
THE BEST WE CAN GET IN
PARTNERSHIP WITH OUR LICENSEES
ON ACCESS PLANS THAT REALLY ARE
TAILORED TO THE PRODUCT, THE
LICENSEE AND THE PATIENT NEEDS,
AND I WOULD NOTE IN TERMS OF
THINKING ABOUT VARIATION FROM
ONE LICENSE TO ANOTHER, IN SOME
CASES OUR LICENSEES WILL NOT BE
AUTHORIZED TO DEVELOP OR SELL A
PRODUCT OUTSIDE THE UNITED
STATES, AND IN OTHER CASES, THE
LICENSEE WILL ONLY BE AUTHORIZED
TO MAKE A PRODUCT OUTSIDE OF THE
UNITED STATES, SO WE REALLY DO
WANT GOOD IDEAS, GUIDANCE,
CLARITY AND CERTAINTY, BUT ALSO
RETAIN THE FLEXIBILITY TO WORK
ON IMPROVING ACCESSORILY ACROSS
THAT RANGE IN WAYS THAT ARE A
WIN, WIN, WIN OUT COME FOR EVE
EVERYONE.
I ALSO WANT TO NOTE, WE'RE NOT
GOING TO STOP DOING WHAT WE
ALREADY DO TO SUPPORT GLOBAL
HEALTH AND TO SUPPORT GLOBAL
ACCESS AS I REFERRED TO SOME OF
THESE STRATEGIES EARLIER, AND I
THINK ONE OF THE EXCITING THINGS
THAT THIS ACCESS PLANNING PO
WILL SEE INVITES US TO DO IS TO
LEVERAGE SOME OF THE STRATEGIES
THAT ARE REAL TRIED AND TRUE
THAT THE AGENCY HAS A LOT OF
EXPERIENCE WITH SUCCESSFULLY
DELIVERING ACCESS SOMETIMES IN A
GLOBAL -- PRIMARILY IN A GLOBAL
DIRECTION, LEVERAGING THOSE SAME
THINGS AND THINKING ABOUT HOW WE
IMPROVE PATIENT ACCESS TO NEW
TREATMENTS WITHIN THE U.S. USING
SOME OF THE SAME PARTNERSHIPS,
SOME OF THE SAME STRATEGIES THAT
WE'VE HAD SUCCESS WITH BEFORE.
>> I'LL ADD ON TO THAT, WE HAVE
MANY TECHNOLOGIES THAT ARE HARD
TO LICENSE NOT JUST BECAUSE
THEY'RE EARLY STAGE, BUT PERHAPS
THEY'RE FOR A RARE DISEASE OR A
NNEGLECTED TROPICAL DISEASE, SO
IN THOSE CASES WE REALLY DEPEND
ON PARTNERSHIPS, NOT THAT WE
JUST LICENSE TO A PARTNER, WE
FIND OTHER STAKEHOLDERS TO
COLLABORATE WITH US TO HELP GET
THAT PRODUCT DEVELOPED AND TO
THE PATIENT, SO THERE'S NO ONE
SIZE FITS ALL, AND WE EXPECT
THAT'S GOING TO BE THE CASE
HERE.
IN THE END, WE JUST WANT TO FIND
SOMETHING THAT'S REASONABLE AND
TO THE EXTENT THAT WE CAN HELP
OUR LICENSEES FIND OTHER WAYS TO
EXPAND ACCESS OR WAYS THAT WE
CAN SUPPORT THEM IN THAT GOAL,
WE WOULD LOVE TO BE ABLE TO
EXPLORE THOSE FURTHER AND ACT ON
THOSE IF WE CAN.
>> OKAY.
THEN THE LAST QUESTION THAT WE
RECEIVED, I WILL READ THIS ONE,
HOW WELL DOES THIS ACCESS WORK
FOR INVESTIGATORS WHO LEAVE NIH
AND START A COMPANY?
SO I THINK BEFORE WE DIVE IN ON
ANSWERING THAT QUESTION, IT'S
PERHAPS WORTH REFLECTING ON SOME
OF THE UNIQUE LEGAL AND ETHICAL
RULES AND POLICIES AND
PROCEDURES THAT ARE IN PLACE TO
AVOID CONFLICTS OF INTEREST FOR
OUR INTRAMURAL PROGRAM
INVESTIGATORS.
AND BECAUSE THERE ARE A LOT OF
THINGS IN PLACE THAT GOVERN THE
WORK OF THE SCIENTISTS HERE ON
CAMPUS.
FOR EXAMPLE, AN NIH INVESTIGATOR
CANNOT START THEIR OWN NEW
COMPANY WHILE THEY'RE CURRENTLY
WORKING AT NIH.
AND ALSO EVEN AFTER AN NIH
EMPLOYEE LEAVES THE AGENCY,
THERE ARE STILL CONSIDERATIONS
AND MAYBE SOME LIMITATIONS ON
WHAT OPTIONS ARE AVAILABLE TO
THEM, SO AN INVESTIGATOR MIGHT
NOT BE ABLE TO JOIN A COMPANY
FOR A FEW YEARS IF THAT COMPANY
IS WORKING ON TECHNOLOGY RELATED
TO WHAT THE INVESTIGATOR WAS
DOING WHILE THEY WERE AT THE
AGENCY.
THERE MIGHT BE RESTRICTIONS ON
THE INVESTIGATOR'S ABILITY TO
NEGOTIATE A PATENT LICENSE
DIRECTLY WITH NIH AFTER THEY
LEAVE, SO THERE ARE SOME SPECIAL
CONSIDERATIONS CERTAINLY IN
PLACE IN THE CIRCUMSTANCE.
ANYTHING ELSE YOU WOULD ADD ON
THAT?
>> NO, JUST TO EMPHASIZE THAT,
YOU KNOW, WE CERTAIN WILL I HAVE
A NUMBER OF FORMER INVESTIGATORS
AT NIH WHO HAVE GONE OUT TO
START COMPANIES EITHER RELATING
TO THEIR TECHNOLOGIES OR
SOMETHING DIFFERENT, AND WE
TREAT EVERYBODY THE SAME.
WE DON'T HAVE PREFERENTIAL
TREATMENT BECAUSE SOMEBODY
WORKED AT NIH.
WE DO THE BEST JOB WE CAN FOR
THEM, AND THAT'S OUR PRIMARY
GOAL.
>> SO I THINK THAT KIND OF GOES
TO THE QUESTION, HOW WOULD THE
ACCESS PLANNING POLICY APPLY
AFTER AN INVESTIGATOR, HE OR SHE
LEFT THE AGENCY AND JOINED THE
COMPANY DOWN THE ROAD
INTERESTING IN LICENSING NIH
TECHNOLOGY, THAT COMPANY WOULD
BE TREATED LIKE ALL OTHER
LICENSEES WHEN IT COMES TO THE
ACCESS PLANNING POLICY.
SO, YEAH.
>> THANKS FOR ALL THOSE GREAT
QUESTIONS.
>> THANKS AGAIN TO EVERYBODY FOR
JOINING AND FOR YOUR ENGAGEMENT
WITH THIS ISSUE AND WE LOOK
FORWARD TO CONTINUING TO HEAR
WHAT FOLKS HAVE TO SAY OVER THE
COMING MONTH AND CHANGE.
>> THANK YOU VERY MUCH, TARA AND
ABBY, AND THANK YOU TO THOSE WHO
WERE ABLE TO JOIN US TODAY.
AS MENTIONED, WE ARE GOING TO
RECORD THIS AND KEEP THIS UP AND
AVAILABLE FOR OTHERS TO LEARN
MORE.
OUR RFI CLOSES JULY 22ND, SO
PLEASE, PLEASE, PLEASE SUBMIT
ANY COMMENTS AND SUGGESTIONS ON
HOW TO MAKE THIS THE STRONGEST
PROPOSAL POSSIBLE.
I THINK WE ARE ALL REALLY
INTERESTED IN MAKING SURE THAT
NIH IS THE WORLD'S LARGEST
FUNDER OF BIOMEDICAL RESEARCH TO
REALLY SHARE OUR COMMITMENT TO
TRANSFORM KNOWLEDGE INTO
IMPROVED HEALTH FOR ALL, AND
THIS IS ONE IMPORTANT WAY IN
WHICH WE ARE CONSIDERING TAKING
SOME ACTION AND COULD BENEFIT
FROM YOUR PERSPECTIVES IN MAKING
THIS AS STRONG AS POSSIBLE.
SO THANK YOU FOR JOINING US
TODAY.
WE LOOK FORWARD TO HEARING YOU
FROM YOU SOON, AND WE'LL BE IN
TOUCH WITH MORE AS WE PROCEED.