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HELLO, EVERYONE.

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WELCOME TO TODAY'S WEBINAR

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FOCUSED ON A DRAFT POLICY

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PROPOSAL ISSUED BY THE NIH TO

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REALLY THINK ABOUT HOW TO

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PROMOTE EQUITY THROUGH ACCESS

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PLANNING.

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I AM LYRIC JORGENSON, ASSOCIATE

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DIRECTOR FOR SCIENCE POLICY HERE

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AT THE NATIONAL INSTITUTES OF

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HEALTH.

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SO AGAIN I'D LIKE TO WELCOME YOU

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FOR JOINING US TODAY.

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WE ARE REALLY EXCITED TO HAVE

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THIS CONVERSATION WITH OUR

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COMMUNITY AND ARE GRATEFUL FOR

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YOUR INTEREST IN THE TOPIC.

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NOW AS MANY OF YOU LIKELY KNOW,

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ON MAY 21ST, NIH ANNOUNCED A

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REQUEST FOR INFORMATION, A WAY

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THAT WE OFTEN SEEK INPUT FROM

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THE PUBLIC, ON A DRAFT PROPOSED

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POLICY FOR THE AGENCY'S

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INTRAMURAL RESEARCH PROGRAM

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WHICH WE'LL BE TALKING ABOUT

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MORE IN DETAIL THROUGH TODAY'S

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WEBINAR.

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THE POLICY REALLY FOCUS ON HOW

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TO PROMOTE EQUITY THROUGH

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VEHICLES SUCH AS ACCESS PLANNING

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SOME OF THE PATIENT ACCESS

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CONSIDERATIONS INTO THE

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COMMERCIALIZATION PROCESS FOR

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NIH-OWNED INVENTIONS.

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THIS PROPOSAL WOULD CALL ON BOTH

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THE AGENCY AND OUR PARTNERS TO

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WORK TOGETHER THROUGH THE PATENT

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LICENSING PROCESS TO BE CREATIVE

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AND EXPLORE WAYS TO EXPAND THE

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REACH OF OUR NIH ACTIVITIES INTO

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THE HANDS OF PATIENT, ESPECIALLY

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AROUND THINGS LIKE NEW DRUGS

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THAT ARE DEVELOPED BASED ON NIH

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INVENTIONS.

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SO OUR GOALS FOR TODAY IS TO

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TELL YOU MORE ABOUT THIS POLICY

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PROPOSAL, PROVIDE INFORMATION

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RELEVANT TO THE RFI, ESPECIALLY

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WITH AN EYE TOWARDS EQUIPPING

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INTERESTED INDIVIDUALS AND

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COMMUNITIES WITH THE BACKGROUND

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AND CONTEXT FOR ANYONE NOT

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FAMILIAR WITH THE NIH INTRAMURAL

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PROGRAM FOR THE WORK WE'RE DOING

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TODAY.

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SO DURING THE NEXT HOUR WE'LL

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HEAR A PRESENTATION ABOUT THE

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NIH INTRAMURAL RESEARCH PROGRAM

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FROM ONE OF THE LEADERS AT THE

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AGENCY'S INTERNAL RESEARCH ARM.

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OUR PRESENTERS WILL DISCUSS

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PATENT LICENSING AT NIH, REVIEW

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THE CONCEPT OF ACCESS PLANNING

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AND DISCUSS THE RFI AND POLICY

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PROPOSAL LED BY ABBY REEVES, THE

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HEAD OF OUR STRATEGIC INNOVATION

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OF TECHNOLOGY TRANSFER POLICY.

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BEFORE WE DIVE IN I WANT TO

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OFFER A FEW REFLECTIONS ON THIS

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POLICY PROPOSAL.

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NOW IT WILL COME AS NO SURPRISE

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TO ANYONE HERE TODAY THAT NIH'S

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INVESTMENTS HAVE PROVEN TO BE A

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CATALYST FOR NEW DRUG

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DEVELOPMENT.

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THROUGH THE RESEARCH WE FUND AND

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CONDUCT, WE HAVE SPURRED PRIVATE

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SECTOR INVESTMENTS IN INNOVATION

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AND NEW THERAPIES THAT HAVE BEEN

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CRITICAL FOR AMERICAN INNOVATION

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AND HEALTH.

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NIH HAS GENERATED BROAD RETURNS

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FOR PUBLIC HEALTH AND THE U.S.

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ECONOMY.

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SO AS I MENTIONED, DR. TARA

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KIRBY WILL SOON SHARE MORE ABOUT

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SPECIFIC WAYS THE INTRAMURAL

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RESEARCH PROGRAM CONTRIBUTES TO

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THESE SUCCESSES.

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I ALSO WANT TO EMPHASIZE THAT

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ALL OF NIH'S ACTIVITIES ARE

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DRIVEN BY THE PRINCIPLE THAT OUR

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WORK IS NOT FINISHED WHEN WE

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DELIVER SCIENTIFIC DISCOVERIES.

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AS YOU'LL HEAR, THE NIH

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DIRECTOR, DR. MONICA BERTAGNOLLI

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SAY, OUR WORK IS FINISHED WHEN

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ALL PEOPLE ARE LIVING LONG AND

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HEALTHY LIVES.

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SO WHEN WE THINK ABOUT

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OPTIMIZING OUR ABILITY TO

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DELIVER ON NIH'S MISSION, WE

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KNOW THAT INVOLVES SEVERAL

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COMPONENTS.

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FIRST, WE KNOW WE NEED TO MAKE

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SURE THAT THE GREAT IDEAS THAT

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COME OUT OF NIH'S WORK CAN GET

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OUT THERE INTO THE HANDS OF

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OTHERS AND IMPROVE PEOPLE'S

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LIVES.

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SECOND, PEOPLE'S LIVES CAN ONLY

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GET BETTER IF THEY CAN ACTUALLY

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ACCESS THE PRODUCTS AND SERVICES

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THAT ARE BUILT ON THE FOUNDATION

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WE BUILD.

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TO THAT END, NIH IS THINKING

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ABOUT ITS CURRENT POLICY AND

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APPROACHES AS A RESEARCH

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INSTITUTION AROUND FACTORS THAT

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CAN SHAPE INNOVATION,

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COMPETITION AND PATIENT ACCESS

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TO CUTTING EDGE MEDICAL

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TECHNOLOGY.

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IMPORTANTLY WE RECOGNIZE NIH

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CANNOT ACHIEVE OUR MISSION OR

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REALIZE PUBLIC HEALTH BENEFITS

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IF PEOPLE CANNOT ACCESS PRODUCTS

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THAT EMERGE FROM OUR WORK.

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THUS WE ARE COMMITTED TO

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ADVANCING EQUITY IN THE

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APPLICATION OF NIH RESEARCH SO

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THAT ALL BENEFITS OF OUR WORK

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ARE AVAILABLE AND AFFORDABLE TO

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ALL AMERICANS.

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AT THE SAME TIME, WE RECOGNIZE

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THAT BIOMEDICAL RESEARCH AND

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HEALTHCARE ECOSYSTEMS ARE

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INCREASINGLY COMPLEX, AND THAT

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MEANS WE NEED TO THINK NOT ONLY

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CREATIVELY BUT STRATEGICALLY

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ABOUT HOW WE CAN SOLVE OR

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PRESENT THE CHALLENGES FOR

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PATIENTS ACCESSING THE CARE THEY

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NEED.

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IMPORTANTLY TODAY'S CONVERSATION

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IS AROUND ONLY ONE PIECE ON

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NIH'S INVESTMENT IN IMPROVING

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PATIENT OUTCOMES.

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FOR THOSE OF YOU THAT HAVE NOT

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ALREADY HEARD, LAST WEEK NIH

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ANOWBSED A NEW INITIATIVE CALLED

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COMMUNITIES ADVANCING RESEARCH

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EQUITY FOR HEALTH, OR CARE FOR

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HEALTH, WHICH SEEKS TO IMPROVE

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ACCESS TO CLINICAL RESEARCH TO

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INFORM MEDICAL CARE,

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PARTICULARLY FOR THOSE IN

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COMMUNITIES HISTORICALLY

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UNDERREPRESENTED IN CLINICAL

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RESEARCH OR UNDERSERVED IN

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HEALTHCARE SETTINGS.

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FINALLY BEFORE I TURN IT OVER TO

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OUR ESTEEMED SPEAKERS TODAY, I

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WANT TO HIGHLIGHT WHERE NIH IS

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IN THE POLICY DEVELOPMENT

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PROCESS, THE RELEASE OF LAST

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MONTH'S REQUEST FOR INFORMATION

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REFLECTS OUR VERY SINCERE

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COMMITMENT TO ENGAGING WITH THE

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PUBLIC TO INFORM OUR POLICIES.

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ONE OF MY HIGHEST PRIORITIES

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HERE AS THE ASSOCIATE DIRECTOR

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FOR SCIENCE POLICY IS MAKING

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SURE EVERYONE HAS AN EQUAL

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OPPORTUNITY AND CAN CONTRIBUTE

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MEANINGFULLY TO THE POLICY

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DEVELOPMENT PROCESS.

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OUR EARS ARE OPEN AND WE ARE

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LISTENING.

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WE ENCOURAGE ANYONE WHO WANTS TO

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SUBMIT PERSPECTIVES, FEED BACKS

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OR IDEAS ON THIS DRAFT PROPOSED

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POLICY TO US AT OUR LINK.

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WE ARE LISTENING.

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BEFORE I TURN OVER TO MIKE, I

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WANT TO ADDRESS A FEW

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HOUSEKEEPING ITEMS.

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AS LIKELY YOU KNOW, THIS WEBINAR

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IS BEING VIDEOCAST BY NIH.

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IT WILL BE RECORDED AND IT WILL

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BE AVAILABLE FOR THOSE WHO

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COULDN'T JOIN US LIVE TODAY.

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NOW I'M EXCITED TO KICK OFF

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TODAY'S DISCUSSION AND TURN

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THINGS OVER TO DR. TARA KIRBY AS

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I MENTIONED WHO WILL PROVIDE

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MORE BACKGROUND ABOUT THE

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INTRAMURAL PROGRAM AND DISCUSS

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PATENT LICENSING AT NIH, AND

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THEN SHE WILL BE JOINED BY,

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AGAIN, ABBY RIVES, DIRECTOR OF

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TECHNOLOGY TRANSFER AND

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INNOVATION POLICY AT NIH OSP.

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DR. KIRBY.

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>> THANK YOU, LYRIC, AND
THANKS

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TO EVERYBODY WHO'S BEEN ABLE TO

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JOIN US TODAY.

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I'M GOING TO START BY PROVIDING

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SOME BACKGROUND THAT I HOPE WILL

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HELP US TO PUT THIS POLICY

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PROPOSAL INTO CONTEXT.

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FIRST OF ALL, WHAT DO WE MEAN

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WHEN WE TALK ABOUT THE NIH

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INTRAMURAL RESEARCH PROGRAM OR

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IRP?

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NEXT I'LL TALK GENERALLY ABOUT

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HOW WE LICENSE TECHNOLOGIES FROM

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THE IRP, WHY WE DO IT, HOW WE DO

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IT AND WHY IT MATTERS.

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SO AS WE STEP OUT TO SEE THE BIG

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PICTURE, AS MANY OF YOU KNOW,

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THIS IS NIH'S MISSION.

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AND THE LAST TWO LINES, I THINK

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ARE VERY IMPORTANT HERE, BECAUSE

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OUR DISCUSSIONS ARE GOING TO

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REALLY FOCUS ON THIS PIECE,

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ABOUT APPLYING KNOWLEDGE TO

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ENHANCE HEALTH, LENGTHEN LIFE

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AND REDUCE ILLNESS AND

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DISABILITY.

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MOST PEOPLE KNOW THAT NIH

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SUPPORTS BASIC RESEARCH, IT

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ACCOUNTS FOR MORE THAN HALF OF

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OUR BUDGET AND IT'S CRITICAL TO

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FUELING PROGRESS FOR NEW

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TREATMENTS AND CURES.

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WE ALSO FOCUS ON TRANSLATIONAL

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RESEARCH THAT HELPS US MOVE

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BASIC DISCOVERIES FORWARD, AND

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CLINICAL RESEARCH WHICH IS

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NEEDED TO REALLY TURN

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DISCOVERIES INTO PREVENTIONS,

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TREATMENTS AND CURES.

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WHEN WE THINK ABOUT OPTIMIZING

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OUR ABILITY TO DELIVER ON THIS

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MISSION, WE KNOW THAT INVOLVES

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SEVERAL COMPONENTS, INCLUDING

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THAT WE NEED TO MAKE SURE THAT

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OUR GREAT IDEAS THAT COME OUT OF

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NIH'S WORK, AS LYRIC MENTIONED,

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CAN ACTUALLY GET OUT THERE TO

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THE WORLD AND IMPROVE PEOPLE'S

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LIVES.

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AND ALSO THAT PEOPLE'S LIVES CAN

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ONLY GET BETTER IF THEY CAN

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ACTUALLY ACCESS THE PRODUCTS AND

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SERVICES THAT ARE BUILT ON OUR

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WORK.

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SO FOR FOLKS WHO DON'T ALREADY

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KNOW, NIH IS MADE UP OF 27

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DIFFERENT COMPONENTS CALLED

262
00:07:44,248 --> 00:07:45,683
INSTITUTES, CENTERS AND OFFICES,

263
00:07:45,683 --> 00:07:47,952
WHICH WE USUALLY REFER TO AS

264
00:07:47,952 --> 00:07:49,253
ICs AND WHICH I'LL PROBABLY BE

265
00:07:49,253 --> 00:07:50,688
SAYING HERE.

266
00:07:50,688 --> 00:07:53,224
EACH IC HAS ITS OWN UNIQUE

267
00:07:53,224 --> 00:07:54,425
MISSION, BUDGET, PRIORITIES,

268
00:07:54,425 --> 00:07:56,627
LEADERSHIP AND FUNDING STRATEGY.

269
00:07:56,627 --> 00:07:58,563
MOST OF THE ICs FUND AND

270
00:07:58,563 --> 00:08:00,331
CONDUCT RESEARCH, THEY HAVE

271
00:08:00,331 --> 00:08:02,200
THEIR OWN RESEARCH AGENDA AND

272
00:08:02,200 --> 00:08:03,501
FOCUS USUALLY ON PARTICULAR

273
00:08:03,501 --> 00:08:07,271
DISEASES OR BODY SYSTEMS.

274
00:08:07,271 --> 00:08:09,473
24 OF THESE 27ICs HAVE

275
00:08:09,473 --> 00:08:10,474
INTRAMURAL RESEARCH PROGRAMS.

276
00:08:10,474 --> 00:08:12,844
THAT MEANS THEY CONDUCT INTERNAL

277
00:08:12,844 --> 00:08:18,783
RESEARCH AT NIH, SPANNING FROM

278
00:08:18,783 --> 00:08:20,318
BASIC, TRANSLATIONAL TO CLINICAL

279
00:08:20,318 --> 00:08:21,085
RESEARCH AT ALL OF OUR

280
00:08:21,085 --> 00:08:21,619
FACILITIES.

281
00:08:21,619 --> 00:08:23,087
THE OFFICE OF THE DIRECTOR UP

282
00:08:23,087 --> 00:08:25,790
THERE IN THE MIDDLE IS THE

283
00:08:25,790 --> 00:08:27,091
CENTRAL OFFICE RESPONSIBLE FOR

284
00:08:27,091 --> 00:08:29,160
SETTING POLICY FOR NIH AND

285
00:08:29,160 --> 00:08:30,261
PLANNING, MANAGING AND

286
00:08:30,261 --> 00:08:32,430
COORDINATING PROGRAMS ACROSS ALL

287
00:08:32,430 --> 00:08:33,998
OF NIH COMPONENTS.

288
00:08:33,998 --> 00:08:37,435
AND THIS HELPS US TO PROVIDE

289
00:08:37,435 --> 00:08:38,502
INTEGRATIVE POLICIES AND

290
00:08:38,502 --> 00:08:40,271
INFRASTRUCTURE ACROSS THE ICs.

291
00:08:40,271 --> 00:08:42,106
MY OFFICE, THE OFFICE OF

292
00:08:42,106 --> 00:08:43,975
TECHNOLOGY TRANSFER, IS PART OF

293
00:08:43,975 --> 00:08:45,176
THE OFFICE OF THE DIRECTOR OR

294
00:08:45,176 --> 00:08:48,145
THE OD.

295
00:08:48,145 --> 00:08:49,780
WE WORK CLOSELY WITH OUR

296
00:08:49,780 --> 00:08:51,449
PARTNERS IN THE TECHNOLOGY

297
00:08:51,449 --> 00:08:52,550
TRANSFER OFFICES IN THE

298
00:08:52,550 --> 00:08:53,951
INSTITUTES AND CENTERS TO ENABLE

299
00:08:53,951 --> 00:08:55,620
TECH TRANSFER, SO THINGS LIKE

300
00:08:55,620 --> 00:08:58,155
EXCHANGING MATERIALS AND DATA,

301
00:08:58,155 --> 00:09:00,658
COLLABORATIONS, PATENTING, AND

302
00:09:00,658 --> 00:09:05,763
LICENSING FOR OUR ENTIRE

303
00:09:05,763 --> 00:09:06,898
INTRAMURAL RESEARCH PROGRAM.

304
00:09:06,898 --> 00:09:09,066
I'LL EXPLAIN MORE ABOUT THAT

305
00:09:09,066 --> 00:09:13,137
NEXT.

306
00:09:13,137 --> 00:09:15,439
WE JUST SAW IN THE LAST SLIDE

307
00:09:15,439 --> 00:09:17,642
THAT NIH HAS 27 ICs, BUT HOW

308
00:09:17,642 --> 00:09:23,114
ARE THESE ICs ALLOCATING

309
00:09:23,114 --> 00:09:23,547
RESOURCES?

310
00:09:23,547 --> 00:09:26,350
WE CAN SEE A BREAKDOWN OF NIH'S

311
00:09:26,350 --> 00:09:27,585
OVERALL BUDGET, HERE I'M SHOWING

312
00:09:27,585 --> 00:09:29,320
THE BUDGET FOR 2022.

313
00:09:29,320 --> 00:09:31,522
MOST OF NIH'S BUDGET IS SPENT

314
00:09:31,522 --> 00:09:32,623
OUTSIDE THE AGENCY AND THAT'S

315
00:09:32,623 --> 00:09:34,058
WHAT MOST PEOPLE KNOW BEST.

316
00:09:34,058 --> 00:09:35,559
FOR EXAMPLE, GRANTS AND

317
00:09:35,559 --> 00:09:39,830
CONTRACTS TO OUR EXTRAMURAL

318
00:09:39,830 --> 00:09:41,032
FOLKS LIKE UNIVERSITIES, MEDICAL

319
00:09:41,032 --> 00:09:42,600
SCHOOLS, OTHER SCIENTIFIC

320
00:09:42,600 --> 00:09:44,435
INSTITUTIONS AND SMALL

321
00:09:44,435 --> 00:09:45,870
BUSINESSES.

322
00:09:45,870 --> 00:09:47,939
WE ALSO FUND GRANTS THAT SUPPORT

323
00:09:47,939 --> 00:09:49,040
LARGE MULTI-PROJECT EFFORTS FOR

324
00:09:49,040 --> 00:09:51,342
A WIDE ARRAY OF RESEARCH

325
00:09:51,342 --> 00:09:53,077
ACTIVITIES AND ALSO TRAINING SO

326
00:09:53,077 --> 00:09:55,379
THAT WE CAN HAVE A SKILLED

327
00:09:55,379 --> 00:09:56,580
WORKFORCE AND PROVIDE FOR THE

328
00:09:56,580 --> 00:09:57,682
NEXT GENERATION OF OUR

329
00:09:57,682 --> 00:10:02,153
INVESTIGATORS.

330
00:10:02,153 --> 00:10:03,721
BUT INTRAMURAL RESEARCH,

331
00:10:03,721 --> 00:10:04,989
RESEARCH CONDUCTED BY NIH

332
00:10:04,989 --> 00:10:07,558
SCIENTISTS THROUGH OUR INTERNAL

333
00:10:07,558 --> 00:10:09,994
PROGRAMS, STILL TOTALS

334
00:10:09,994 --> 00:10:12,363
$4.8 BILLION, OR ABOUT 11% OF

335
00:10:12,363 --> 00:10:19,270
OWRP OVERALOUR OVERALL BUDGET, R

336
00:10:19,270 --> 00:10:19,870
PROPORTIONS OVER THE YEARS.

337
00:10:19,870 --> 00:10:21,472
SO NOW WE'RE GOING TO TALK ON

338
00:10:21,472 --> 00:10:29,513
THIS SPECIFIC 11% SLICE.

339
00:10:29,513 --> 00:10:32,350
SO AS YOU CAN IMAGINE, OUR IRP

340
00:10:32,350 --> 00:10:34,552
IS VERY DIVERSE, BUT THIS SLIDE

341
00:10:34,552 --> 00:10:36,220
PROVIDES A SNAPSHOT OF A FEW

342
00:10:36,220 --> 00:10:39,056
WAYS TO UNDERSTAND ITS SCOPE.

343
00:10:39,056 --> 00:10:40,925
WE HAVE MORE THAN 5,000

344
00:10:40,925 --> 00:10:43,394
SCIENTISTS WORKING ON OVER 3,000

345
00:10:43,394 --> 00:10:45,329
PROJECTS, AND MANY OF THOSE ARE

346
00:10:45,329 --> 00:10:46,731
TRAINEES, AND WE ALSO HAVE A

347
00:10:46,731 --> 00:10:48,132
LARGE NUMBER OF SENIOR

348
00:10:48,132 --> 00:10:49,567
RESEARCHERS.

349
00:10:49,567 --> 00:10:52,436
MANY OF THESE PROJECTS THAT ARE

350
00:10:52,436 --> 00:10:53,738
OCCURRING RELY ON

351
00:10:53,738 --> 00:10:56,474
COLLABORATIONS, AND IN 2023, WE

352
00:10:56,474 --> 00:10:59,443
PUT MORE THAN 4600 COLLABORATION

353
00:10:59,443 --> 00:11:01,846
AGREEMENTS INTO PLACE TO HELP

354
00:11:01,846 --> 00:11:03,147
FACILITATE WORK BY OUR

355
00:11:03,147 --> 00:11:04,348
RESEARCHERS, RANGING FROM

356
00:11:04,348 --> 00:11:07,952
MATERIAL TRANSFERS, INFORMATION

357
00:11:07,952 --> 00:11:10,254
TRANSFERS TO MULTIYEAR PROJECTS

358
00:11:10,254 --> 00:11:11,355
AND CLINICAL TRIALS.

359
00:11:11,355 --> 00:11:15,860
ALSO IN 2023, WE FILED A TOTAL

360
00:11:15,860 --> 00:11:18,796
OF 187 NEW PATENTS FOR THE NIH

361
00:11:18,796 --> 00:11:19,997
INTRAMURAL PROGRAM.

362
00:11:19,997 --> 00:11:23,734
AND WE EXECUTED 273 LICENSES

363
00:11:23,734 --> 00:11:25,703
THAT YEAR, ALSO, BOTH FOR

364
00:11:25,703 --> 00:11:29,740
PATENTS AND OTHER INVENTIONS.

365
00:11:29,740 --> 00:11:32,043
THE IRP IS BASICALLY THE LARGEST

366
00:11:32,043 --> 00:11:33,878
BIOMEDICAL RESEARCH INSTITUTION

367
00:11:33,878 --> 00:11:34,945
ON THE EARTH AND SOMETIMES FEELS

368
00:11:34,945 --> 00:11:36,080
LIKE THAT HERE.

369
00:11:36,080 --> 00:11:38,182
AND IT COVERS MANY DISEASE AREAS

370
00:11:38,182 --> 00:11:39,817
AND TECHNOLOGIES FROM

371
00:11:39,817 --> 00:11:41,118
FUNDAMENTAL DISCOVERIES TO

372
00:11:41,118 --> 00:11:43,087
RESEARCH TOOLS TO INNOVATIONS

373
00:11:43,087 --> 00:11:45,489
THAT MAY BECOME FUTURE DRUGS,

374
00:11:45,489 --> 00:11:47,058
VACCINES, DEVICES AND OTHER

375
00:11:47,058 --> 00:11:55,499
PRODUCTS TO BENEFIT THE PUBLIC.

376
00:11:55,499 --> 00:11:57,268
SO I. WANTED TO GIVE JUST A VERY

377
00:11:57,268 --> 00:11:58,235
BRIEF IDEA OF THE LEGAL

378
00:11:58,235 --> 00:12:00,638
FRAMEWORK FOR NIH'S LICENSING.

379
00:12:00,638 --> 00:12:02,173
WHAT ALLOWS US TO ENGAGE IN

380
00:12:02,173 --> 00:12:05,242
LICENSING AND OTHER TECH

381
00:12:05,242 --> 00:12:06,544
TRANSFER ACTIVITIES IN THE NIH

382
00:12:06,544 --> 00:12:07,678
INTRAMURAL RESEARCH PROGRAM?

383
00:12:07,678 --> 00:12:09,346
THERE IS A NETWORK OF LAWS THAT

384
00:12:09,346 --> 00:12:11,315
GOVERN  PATENTING AND LICENSING

385
00:12:11,315 --> 00:12:12,683
OF GOVERNMENT-OWNED INVENTIONS.

386
00:12:12,683 --> 00:12:16,554
THE FOUNDATIONAL LAW IS THE

387
00:12:16,554 --> 00:12:18,856
STEVENSON WYDLER TECHNOLOGY

388
00:12:18,856 --> 00:12:20,291
INNOVATION ACT OF 1980 WHICH

389
00:12:20,291 --> 00:12:21,826
MANDATED THAT FEDERAL AGENCIES

390
00:12:21,826 --> 00:12:23,227
TRANSFER THEIR TECHNOLOGIES TO

391
00:12:23,227 --> 00:12:25,529
NON-FEDERAL PARTIES FOR

392
00:12:25,529 --> 00:12:25,830
DEVELOPMENT.

393
00:12:25,830 --> 00:12:27,431
THIS IS SUPPORTED BY OTHER LAWS

394
00:12:27,431 --> 00:12:30,134
SUCH AS BAYH-DOLE, WHICH IS

395
00:12:30,134 --> 00:12:32,303
PRIMARILY KNOWN AS THE LAW THAT

396
00:12:32,303 --> 00:12:33,537
LETS RECIPIENTS OF FEDERAL

397
00:12:33,537 --> 00:12:35,272
FUNDING TO OBTAIN TITLE TO

398
00:12:35,272 --> 00:12:36,040
INVENTIONS.

399
00:12:36,040 --> 00:12:37,775
BUT IT ALSO AUTHORIZED THE

400
00:12:37,775 --> 00:12:39,743
GOVERNMENT TO EXCLUSIVELY

401
00:12:39,743 --> 00:12:41,378
LICENSE ITS TECHNOLOGIES.

402
00:12:41,378 --> 00:12:43,881
THE FTTA, FEDERAL TECHNOLOGY

403
00:12:43,881 --> 00:12:46,083
TRANSFER ACT, DECENT LIETZED

404
00:12:46,083 --> 00:12:47,218
GOVERNMENT TECH TRANSFER TO

405
00:12:47,218 --> 00:12:48,719
INDIVIDUAL AGENCIES, WHICH IS

406
00:12:48,719 --> 00:12:51,689
HOW OTT CAME INTO BEING.

407
00:12:51,689 --> 00:12:59,096
THESE LAWS ARE CODIFIED IN 35USC

408
00:12:59,096 --> 00:13:00,965
207-209 AND ALSO PROMULGATED IN

409
00:13:00,965 --> 00:13:04,802
37  CFR 404.

410
00:13:04,802 --> 00:13:06,237
THAT'S ESSENTIALLY OUR BIBLE

411
00:13:06,237 --> 00:13:07,705
WHEN IT COMES TO HOW WE LICENSE

412
00:13:07,705 --> 00:13:13,244
OUR OWN TECHNOLOGIES.

413
00:13:13,244 --> 00:13:14,645
SO WE ARE PERMITTED TO LICENSE

414
00:13:14,645 --> 00:13:16,847
OUR TECHNOLOGIES, BUT WHY DO WE

415
00:13:16,847 --> 00:13:20,885
DO THAT ANYWAY?

416
00:13:20,885 --> 00:13:23,454
A SUCCINCT STATEMENT OF THIS IS

417
00:13:23,454 --> 00:13:27,057
IN 37SFR 404, TO PROMOTE THE

418
00:13:27,057 --> 00:13:29,126
RESULTS OF FEDERALLY FUNDED

419
00:13:29,126 --> 00:13:29,894
RESEARCH AND DEVELOP THE.

420
00:13:29,894 --> 00:13:32,530
BUT IN PRACTICE, WHAT DOES THIS

421
00:13:32,530 --> 00:13:34,064
MEAN?

422
00:13:34,064 --> 00:13:35,399
GENERALLY WE WANT TO UTILIZE OUR

423
00:13:35,399 --> 00:13:37,801
IP AS AN INCENTIVE FOR

424
00:13:37,801 --> 00:13:39,003
COMMERCIAL DEVELOPMENT, AND

425
00:13:39,003 --> 00:13:40,070
PATENT PROTECTION IN PARTICULAR

426
00:13:40,070 --> 00:13:42,173
MAY BE A KEY INCENTIVE TO

427
00:13:42,173 --> 00:13:43,707
DEVELOP RISKY BIOMEDICAL

428
00:13:43,707 --> 00:13:45,576
TECHNOLOGIES.

429
00:13:45,576 --> 00:13:47,211
LICENSING CAN ALSO ATTRACT NEW

430
00:13:47,211 --> 00:13:49,680
R & D RESOURCES, FOR
EXAMPLE,

431
00:13:49,680 --> 00:13:51,282
WHEN A LICENSING PARTER IN IS

432
00:13:51,282 --> 00:13:52,883
ABLE TO RAISE CAPITAL TO CONDUCT

433
00:13:52,883 --> 00:13:55,085
A CLINICAL TRIAL.

434
00:13:55,085 --> 00:13:56,587
WE ALSO WANT TO GET A RETURN ON

435
00:13:56,587 --> 00:13:58,822
THE PUBLIC'S INVESTMENT, AND

436
00:13:58,822 --> 00:14:00,357
CERTAINLY THAT MIGHT INVOLVE

437
00:14:00,357 --> 00:14:01,759
RECOUPING THE FUNDS WE USE TO

438
00:14:01,759 --> 00:14:03,427
CONDUCT OUR RESEARCH AND PAY FOR

439
00:14:03,427 --> 00:14:06,397
PATENT COSTS, BUT EVEN MORE

440
00:14:06,397 --> 00:14:07,698
IMPORTANTLY, WE WOULD LIKE TO

441
00:14:07,698 --> 00:14:09,667
REALIZE THE POTENTIAL OF NIH'S

442
00:14:09,667 --> 00:14:11,735
RESEARCH DISCOVERIES.

443
00:14:11,735 --> 00:14:13,504
LICENSING IS ALSO A WAY TO

444
00:14:13,504 --> 00:14:16,440
STIMULATE ECONOMIC DEVELOPMENT,

445
00:14:16,440 --> 00:14:18,609
WHICH CAN MAKE THE INNOVATION

446
00:14:18,609 --> 00:14:19,410
ECOSYSTEM MORE ROBUST AND HELP

447
00:14:19,410 --> 00:14:22,713
TO DRIVE NEW DISCOVERIES IN ITS

448
00:14:22,713 --> 00:14:22,913
TURN.

449
00:14:22,913 --> 00:14:24,481
OF COURSE, THOUGH, NIH HAS A

450
00:14:24,481 --> 00:14:26,850
VERY SPECIFIC REASON ALSO TO

451
00:14:26,850 --> 00:14:28,152
LICENSE THIS TECHNOLOGY, WHICH

452
00:14:28,152 --> 00:14:29,253
COMES BACK TO THE CORE PART OF

453
00:14:29,253 --> 00:14:31,255
ITS MISSION, WHICH IS TO BENEFIT

454
00:14:31,255 --> 00:14:31,822
THE PUBLIC HEALTH.

455
00:14:31,822 --> 00:14:34,391
AND THIS IS GENERALLY OUR FIRST

456
00:14:34,391 --> 00:14:35,092
CONSIDERATION IN ANY LICENSE

457
00:14:35,092 --> 00:14:44,068
THAT WE NEGOTIATE.

458
00:14:44,068 --> 00:14:45,836
SO WHILE THE IRP IS A SLICE OF

459
00:14:45,836 --> 00:14:46,704
WHAT NIH DOES AND PA AT THE

460
00:14:46,704 --> 00:14:56,413
PRESENT TIMAT THEPRPATENTING AN,

461
00:14:56,413 --> 00:14:57,514
OUR LICENSES HAVE RESULTED IN

462
00:14:57,514 --> 00:14:58,682
MORE THAN A THOUSAND PRODUCTS

463
00:14:58,682 --> 00:15:00,084
BROUGHT TO MARKET OVER THE LAST

464
00:15:00,084 --> 00:15:02,286
30 YEARS OR SO.

465
00:15:02,286 --> 00:15:05,956
THESE INCLUDE AN IMPRESSIVE 46

466
00:15:05,956 --> 00:15:08,058
FDA-APPROVED VACCINES AND

467
00:15:08,058 --> 00:15:09,193
THERAPEUTICS, AND EVEN MORE

468
00:15:09,193 --> 00:15:10,828
PRODUCTS HAVE BEEN AUTHORIZED

469
00:15:10,828 --> 00:15:12,896
THROUGH OTHER AUTHORITIES SUCH

470
00:15:12,896 --> 00:15:15,532
AS IN VITRO DIAGNOSTICS AND ALSO

471
00:15:15,532 --> 00:15:16,533
PRODUCTS AUTHORIZED FOR USE IN

472
00:15:16,533 --> 00:15:19,703
OTHER COUNTRIES.

473
00:15:19,703 --> 00:15:21,238
AND ALSO IN ADDITION TO BRINGING

474
00:15:21,238 --> 00:15:23,440
THESE IMPORTANT TECHNOLOGIES TO

475
00:15:23,440 --> 00:15:25,209
MARKET, THE PROGRESS FOR R &
D

476
00:15:25,209 --> 00:15:27,111
IN A MORE BROAD SENSE.

477
00:15:27,111 --> 00:15:29,013
IN A RECENT REPORT THAT WE PUT

478
00:15:29,013 --> 00:15:30,681
TOGETHER DESCRIBING THE IMPACT

479
00:15:30,681 --> 00:15:32,783
OF OUR LICENSING PROGRAM, WE

480
00:15:32,783 --> 00:15:34,518
FOUND THAT IRP TECHNOLOGIES WERE

481
00:15:34,518 --> 00:15:37,254
USED IN OVER 1200 CLINICAL

482
00:15:37,254 --> 00:15:38,989
TRIALS AND WERE CITED IN

483
00:15:38,989 --> 00:15:39,990
NUMEROUS PATENT APPLICATIONS

484
00:15:39,990 --> 00:15:43,160
FILED BY OUR LICENSEES.

485
00:15:43,160 --> 00:15:44,595
THE REPORT ALSO SHOWED THAT AS

486
00:15:44,595 --> 00:15:47,431
IMPORTANT AS OUR FDA-APPROVED

487
00:15:47,431 --> 00:15:48,732
PRODUCTS ARE AND THOSE LICENSES

488
00:15:48,732 --> 00:15:51,802
ARE TO OUR OVERALL GOALS, THE

489
00:15:51,802 --> 00:15:53,470
NIH ALSO HAS AN ENORMOUS IMPACT

490
00:15:53,470 --> 00:15:56,106
THROUGH MAKING RESEARCH TOOLS

491
00:15:56,106 --> 00:15:57,374
AVAILABLE TO INDUSTRY, AND THESE

492
00:15:57,374 --> 00:15:59,910
ACCOUNT FOR OVER 60% OF OUR

493
00:15:59,910 --> 00:16:01,545
LICENSES.

494
00:16:01,545 --> 00:16:02,313
AND IN ACCORDANCE WITH THIS,

495
00:16:02,313 --> 00:16:03,847
MOST OF OUR LICENSES ARE

496
00:16:03,847 --> 00:16:10,187
NON-EXCLUSIVE.

497
00:16:10,187 --> 00:16:11,955
I'D ALSO JUST LIKE TO TAKE A

498
00:16:11,955 --> 00:16:13,490
MOMENT TO HIGHLIGHT A FEW OF THE

499
00:16:13,490 --> 00:16:15,225
VACCINES AND THERAPEUTICS ON THE

500
00:16:15,225 --> 00:16:16,627
MARKET THAT UTILIZE SOMETHING

501
00:16:16,627 --> 00:16:17,728
DEVELOPED FROM THE IRP

502
00:16:17,728 --> 00:16:21,098
TECHNOLOGY PROGRAM.

503
00:16:21,098 --> 00:16:23,133
MANY PEOPLE ARE PROBABLY

504
00:16:23,133 --> 00:16:29,139
FAMILIAR WITH COMIRNATY, A

505
00:16:29,139 --> 00:16:31,108
COVID-19 VACCINE.

506
00:16:31,108 --> 00:16:33,510
OTHER RECENT TECHNOLOGIES ARE

507
00:16:33,510 --> 00:16:35,713
EBANGA, A HUMAN MONOCLONAL

508
00:16:35,713 --> 00:16:37,781
ANTIBODY FOR TREATING EBOLA

509
00:16:37,781 --> 00:16:40,617
VIRUS.

510
00:16:40,617 --> 00:16:43,153
AREXVY IS AN RSV VACCINE FOR

511
00:16:43,153 --> 00:16:45,122
INDIVIDUALS 60 YEARS OF AGE OR

512
00:16:45,122 --> 00:16:46,990
OLDER.

513
00:16:46,990 --> 00:16:49,193
ZOKINVY IS A DRUG THAT HELPS

514
00:16:49,193 --> 00:16:53,797
PREVENT THE BUILDUP OF PROGERIA,

515
00:16:53,797 --> 00:16:57,534
A DISEASE WHERE CHILDREN AGE

516
00:16:57,534 --> 00:16:59,069
PREMATURELY.

517
00:16:59,069 --> 00:17:01,372
AND ABECMA IS A CAR-T-CELL

518
00:17:01,372 --> 00:17:03,273
THERAPY TREATMENT FOR MULTIPLE

519
00:17:03,273 --> 00:17:03,907
MYELOMA.

520
00:17:03,907 --> 00:17:06,176
THERE ARE EVEN MORE RECENT

521
00:17:06,176 --> 00:17:07,611
APPROVALS THAT I HAVEN'T HAD THE

522
00:17:07,611 --> 00:17:09,446
CHANCE TO PUT ON THE SLIDE, BUT

523
00:17:09,446 --> 00:17:13,183
SOME OF THEM INCLUDE DRUGS FOR

524
00:17:13,183 --> 00:17:16,353
TREATING HEMOPHILIA, WHICH IS

525
00:17:16,353 --> 00:17:17,688
HAS BEEN A VERY ELUSIVE GOAL,

526
00:17:17,688 --> 00:17:19,123
AND ALSO FOR THE TREATMENT OF

527
00:17:19,123 --> 00:17:24,461
MELANOMA.

528
00:17:24,461 --> 00:17:26,563
I'D ALSO LIKE TO TALK JUST FOR A

529
00:17:26,563 --> 00:17:28,599
SECOND ABOUT WHO IS LICENSING

530
00:17:28,599 --> 00:17:29,833
NIH'S TECHNOLOGIES.

531
00:17:29,833 --> 00:17:32,002
OUR RECENT IMPACT REPORT

532
00:17:32,002 --> 00:17:33,804
CONFIRMED SOMETHING THAT WE

533
00:17:33,804 --> 00:17:35,406
ALREADY KNEW, IT'S NOT JUST BIG

534
00:17:35,406 --> 00:17:37,040
PHARMAS AND BIOTECH COMPANIES

535
00:17:37,040 --> 00:17:37,708
THAT LICENSE FROM US.

536
00:17:37,708 --> 00:17:40,477
IN FACT, FOR OUR MOST SUCCESSFUL

537
00:17:40,477 --> 00:17:41,412
TECHNOLOGIES, ABOUT A THIRD OF

538
00:17:41,412 --> 00:17:43,080
THEM WERE LICENSED BY

539
00:17:43,080 --> 00:17:45,382
EARLY-STAGE COMPANIES.

540
00:17:45,382 --> 00:17:47,451
THIS WAS TRUE ACROSS PRODUCT

541
00:17:47,451 --> 00:17:49,286
TYPES, DIAGNOSTICS, RESEARCH

542
00:17:49,286 --> 00:17:52,589
TOOLS, THERAPEUTICS AND DEVICES.

543
00:17:52,589 --> 00:17:54,458
AND THAT PROBABLY REFLECTS THE

544
00:17:54,458 --> 00:17:55,893
FACT THAT SOMETIMES SMALL

545
00:17:55,893 --> 00:17:57,828
COMPANIES ARE THE ONLY ONES

546
00:17:57,828 --> 00:17:59,296
WILLING TO TAKE ON THE

547
00:17:59,296 --> 00:18:00,697
SUBSTANTIAL RISK OF AN EARLY

548
00:18:00,697 --> 00:18:02,232
STAGE TECHNOLOGY, WHICH IS THE

549
00:18:02,232 --> 00:18:04,101
VAST MAJORITY OF THE

550
00:18:04,101 --> 00:18:07,938
TECHNOLOGIES NIH HAS.

551
00:18:07,938 --> 00:18:12,209
PEOPLE ALSO ASSUME NIH ONLY

552
00:18:12,209 --> 00:18:14,711
LICENSES TO U.S. COMPANIES.

553
00:18:14,711 --> 00:18:18,015
AND THAT'S DEFINITELY NOT TRUE.

554
00:18:18,015 --> 00:18:19,316
ONE OF EVERY THREE OF OUR

555
00:18:19,316 --> 00:18:20,317
LICENSES IS TO A FOREIGN

556
00:18:20,317 --> 00:18:21,552
COMPANY.

557
00:18:21,552 --> 00:18:22,986
IF YOU THINK ABOUT THIS, IT

558
00:18:22,986 --> 00:18:25,022
MAKES SENSE.

559
00:18:25,022 --> 00:18:26,356
IN BIOMEDICAL RESEARCH,

560
00:18:26,356 --> 00:18:27,524
INTERNATIONAL COLLABORATIONS ARE

561
00:18:27,524 --> 00:18:29,960
OFTEN A CRITICAL PART OF

562
00:18:29,960 --> 00:18:32,262
SUPPORTING THE BEST SCIENCE

563
00:18:32,262 --> 00:18:33,130
INNOVATION, AND SOME

564
00:18:33,130 --> 00:18:34,364
TECHNOLOGIES LIKE THOSE FOR

565
00:18:34,364 --> 00:18:36,667
NEGLECTED TROPICAL DISEASES MAY

566
00:18:36,667 --> 00:18:37,734
BE BEST SUITED FOR DEVELOPMENT

567
00:18:37,734 --> 00:18:39,736
BY AN INTERNATIONAL PARTNER THAT

568
00:18:39,736 --> 00:18:41,138
HAS THE APPROPRIATE REGIONAL

569
00:18:41,138 --> 00:18:48,045
EXPERTISE AND RESOURCES.

570
00:18:48,045 --> 00:18:50,547
BOTH THE LEGAL FRAMEWORK FOR

571
00:18:50,547 --> 00:18:51,215
GOVERNMENT LICENSING, WHICH I'VE

572
00:18:51,215 --> 00:18:53,650
ALREADY TALKED ABOUT, AND NIH'S

573
00:18:53,650 --> 00:18:55,085
GOALS FEED INTO OUR GENERAL

574
00:18:55,085 --> 00:18:56,687
PRINCIPLES THAT WE FOLLOW FOR

575
00:18:56,687 --> 00:18:58,222
LICENSING TECHNOLOGIES FROM THE

576
00:18:58,222 --> 00:18:59,623
IRP.

577
00:18:59,623 --> 00:19:01,825
FIRST, WE WANT TO DO OUR BEST TO

578
00:19:01,825 --> 00:19:02,726
GRANT THE APPROPRIATE SCOPE OF

579
00:19:02,726 --> 00:19:06,196
RIGHTS.

580
00:19:06,196 --> 00:19:07,865
THE LICENSE SHOULD REFLECT THE

581
00:19:07,865 --> 00:19:09,066
LICENSEE'S PLANS AND ABILITIES

582
00:19:09,066 --> 00:19:09,967
TO DEVELOP THE TECHNOLOGY AND

583
00:19:09,967 --> 00:19:11,835
NOT BE A BLANKET GRANT.

584
00:19:11,835 --> 00:19:13,470
THIS MEANS TAILORING THE FIELD

585
00:19:13,470 --> 00:19:16,106
OF USE, THE TERRITORY WHERE THE

586
00:19:16,106 --> 00:19:17,207
LICENSEE CAN MAKE OR SELL THE

587
00:19:17,207 --> 00:19:19,009
PRODUCT OR SERVICE, AS WELL AS

588
00:19:19,009 --> 00:19:22,246
OTHER FACTORS.

589
00:19:22,246 --> 00:19:24,848
THIS ALSO INCLUDES LICENSING

590
00:19:24,848 --> 00:19:25,949
NON-EXCLUSIVELY WHEREVER

591
00:19:25,949 --> 00:19:27,284
POSSIBLE OR LIMITING

592
00:19:27,284 --> 00:19:27,818
EXCLUSIVITY.

593
00:19:27,818 --> 00:19:29,019
I'VE ALREADY MENTIONED THAT MOST

594
00:19:29,019 --> 00:19:32,022
OF OUR LICENSES ARE NOT

595
00:19:32,022 --> 00:19:33,156
EXCLUSIVE, AND THIS IS NOT AN

596
00:19:33,156 --> 00:19:34,725
ACCIDENT.

597
00:19:34,725 --> 00:19:36,159
WE WANT TO ALLOW THE BROADEST

598
00:19:36,159 --> 00:19:37,361
POSSIBLE DEVELOPMENT AND

599
00:19:37,361 --> 00:19:39,530
DISSEMINATION OF THE TECHNOLOGY

600
00:19:39,530 --> 00:19:41,198
IN ALL OF THESE ASPECTS IF WE

601
00:19:41,198 --> 00:19:42,432
CAN.

602
00:19:42,432 --> 00:19:44,301
IT'S ALSO CRITICAL TO US AS A

603
00:19:44,301 --> 00:19:46,403
RESEARCH INSTITUTION TO PRESERVE

604
00:19:46,403 --> 00:19:47,437
RESEARCH USE OF THE TECHNOLOGY,

605
00:19:47,437 --> 00:19:51,608
BOTH BY NIH AND BY OTHERS, SO

606
00:19:51,608 --> 00:19:54,011
THAT FURTHER R & D CAN BE

607
00:19:54,011 --> 00:19:55,012
FACILITATED AND WE CAN DEVELOP

608
00:19:55,012 --> 00:19:56,947
NEW TECHNOLOGIES.

609
00:19:56,947 --> 00:19:59,483
OUR LICENSES ALSO INCLUDE

610
00:19:59,483 --> 00:20:00,951
ENFORCEABLE MILESTONES AND

611
00:20:00,951 --> 00:20:02,352
BENCHMARKS THAT LET US TRACK HOW

612
00:20:02,352 --> 00:20:04,021
THE LICENSEE IS DOING AS IT

613
00:20:04,021 --> 00:20:05,522
DEVELOPS AND EVENTUALLY

614
00:20:05,522 --> 00:20:08,258
COMMERCIALIZES OUR TECHNOLOGIES.

615
00:20:08,258 --> 00:20:10,227
AND ALLOWS US TO GET INVOLVED IF

616
00:20:10,227 --> 00:20:11,662
THINGS GO OFF TRACK, AND I CAN

617
00:20:11,662 --> 00:20:12,663
TELL YOU A LITTLE BIT MORE ABOUT

618
00:20:12,663 --> 00:20:15,399
THAT IN A MINUTE.

619
00:20:15,399 --> 00:20:17,701
WE ALSO WANT A LICENSING

620
00:20:17,701 --> 00:20:19,803
STRATEGY THAT LETS US GET THE

621
00:20:19,803 --> 00:20:21,004
MOST OUT OF OUR TECHNOLOGIES.

622
00:20:21,004 --> 00:20:22,639
MANY OF THEM, PARTICULARLY

623
00:20:22,639 --> 00:20:24,608
FOUNDATIONAL ONES LIKE THE SARS

624
00:20:24,608 --> 00:20:26,376
STABILIZED SPIKE PROTEIN

625
00:20:26,376 --> 00:20:27,778
TECHNOLOGY THAT WAS THE BASIS OF

626
00:20:27,778 --> 00:20:29,846
THE COVID-19 VACCINE, MANY OF

627
00:20:29,846 --> 00:20:31,882
THESE TECHNOLOGIES HAVE MULTIPLE

628
00:20:31,882 --> 00:20:32,382
USES.

629
00:20:32,382 --> 00:20:34,685
SO MORE LICENSES FOR MORE USES

630
00:20:34,685 --> 00:20:37,387
EXPANDS THE POTENTIAL FOR PUBLIC

631
00:20:37,387 --> 00:20:38,288
BENEFIT.

632
00:20:38,288 --> 00:20:40,357
AND OF COURSE WE WANT TO ENSURE

633
00:20:40,357 --> 00:20:41,325
AN APPROPRIATE RETURN ON THE

634
00:20:41,325 --> 00:20:46,396
PUBLIC'S INVESTMENT.

635
00:20:46,396 --> 00:20:47,764
NOW I'M GOING TO TALK A LITTLE

636
00:20:47,764 --> 00:20:50,100
BIT ABOUT NIH'S LICENSING

637
00:20:50,100 --> 00:20:50,334
PROCESS.

638
00:20:50,334 --> 00:20:52,202
THIS COULD BE AN ENTIRE TALK ON

639
00:20:52,202 --> 00:20:54,438
ITS OWN, BUT HOPEFULLY I CAN

640
00:20:54,438 --> 00:20:56,506
SHARE THE ESSENTIALS IN A FEW

641
00:20:56,506 --> 00:20:57,374
SLIDES.

642
00:20:57,374 --> 00:21:00,243
THIS DIAGRAM SHOWS A VERY

643
00:21:00,243 --> 00:21:02,112
SIMPLIFIED VERSION OF HOW AN

644
00:21:02,112 --> 00:21:03,313
INVENTION MIGHT MOVE FROM AN

645
00:21:03,313 --> 00:21:05,849
INITIAL DISCOVERY TO A LICENSE

646
00:21:05,849 --> 00:21:06,383
AND BEYOND.

647
00:21:06,383 --> 00:21:08,018
WHILE THE DEVELOPMENT PROCESS

648
00:21:08,018 --> 00:21:09,319
AFTER THE TECHNOLOGY IS LICENSED

649
00:21:09,319 --> 00:21:11,221
IS OF COURSE VERY IMPORTANT, WE

650
00:21:11,221 --> 00:21:13,290
ARE ONLY FOCUSING ON THE GENERAL

651
00:21:13,290 --> 00:21:14,725
PROCESS HERE AS IT PERTAINS TO

652
00:21:14,725 --> 00:21:16,259
NIH.

653
00:21:16,259 --> 00:21:18,128
IN FACT, THIS IS ESSENTIALLY THE

654
00:21:18,128 --> 00:21:19,630
SAME PROCESS THAT ANY

655
00:21:19,630 --> 00:21:20,631
ORGANIZATION MIGHT USE WHEN

656
00:21:20,631 --> 00:21:21,832
PARTNERING WITH A COMPANY TO

657
00:21:21,832 --> 00:21:24,935
DEVELOP THIS TECHNOLOGY,

658
00:21:24,935 --> 00:21:25,802
ESPECIALLY EARLY STAGE

659
00:21:25,802 --> 00:21:27,571
TECHNOLOGIES.

660
00:21:27,571 --> 00:21:28,705
ONCE AN INVESTIGATOR MAKES

661
00:21:28,705 --> 00:21:30,307
SOMETHING THEY THINK COULD BE AN

662
00:21:30,307 --> 00:21:31,742
INVENTION, THEY REPORT TO THEIR

663
00:21:31,742 --> 00:21:35,912
TECH TRANSFER CONTACT AND

664
00:21:35,912 --> 00:21:37,214
INSTITUTE OR CENTER TECH

665
00:21:37,214 --> 00:21:39,082
TRANSFER OFFICE.

666
00:21:39,082 --> 00:21:40,884
THEY EVALUATE AND WORK WITH THE

667
00:21:40,884 --> 00:21:41,485
INVESTIGATOR TO DETERMINE HOW

668
00:21:41,485 --> 00:21:42,919
BEST TO DISSEMINATE IT, WHICH

669
00:21:42,919 --> 00:21:44,221
COULD INCLUDE PATENT PROTECTION

670
00:21:44,221 --> 00:21:45,756
WHEN NEEDED TO PROVIDE AN

671
00:21:45,756 --> 00:21:49,893
INCENTIVE, BUT NOT ALWAYS.

672
00:21:49,893 --> 00:21:51,595
THEN NIH SEEKS LICENSING

673
00:21:51,595 --> 00:21:53,363
PARTNERS THROUGH A VARIETY OF

674
00:21:53,363 --> 00:21:55,232
METHODS AND ONCE THEY FIND A

675
00:21:55,232 --> 00:21:56,466
PARTNER OR HOPEFULLY PARTNERS,

676
00:21:56,466 --> 00:21:58,402
THEY WORK TO NEGOTIATE A LICENSE

677
00:21:58,402 --> 00:21:59,603
WITH THOSE PARTNERS FOLLOWING

678
00:21:59,603 --> 00:22:00,837
THE PRINCIPLES THAT I HAD JUST

679
00:22:00,837 --> 00:22:01,605
MENTIONED.

680
00:22:01,605 --> 00:22:04,241
AND ONCE EXECUTED, THE COMPANY

681
00:22:04,241 --> 00:22:05,308
STARTS DOWN THE ROAD OF

682
00:22:05,308 --> 00:22:06,510
DEVELOPMENT AND

683
00:22:06,510 --> 00:22:07,744
COMMERCIALIZATION AND NIH WILL

684
00:22:07,744 --> 00:22:14,685
TRACK THEIR PROGRESS.

685
00:22:14,685 --> 00:22:16,887
SO STEPPING BACK A LITTLE BIT TO

686
00:22:16,887 --> 00:22:18,588
NEGOTIATING THE LICENSE, WHEN IT

687
00:22:18,588 --> 00:22:21,124
COMES TO NEGOTIATING TERMS,

688
00:22:21,124 --> 00:22:22,893
THERE SEEMS TO BE THE MOST

689
00:22:22,893 --> 00:22:25,629
OUTSIDE INTEREST IN FINANCIALS,

690
00:22:25,629 --> 00:22:27,731
ESPECIALLY THE ROYALTY RATE ON

691
00:22:27,731 --> 00:22:29,166
PRODUCT SALES, AND THAT'S

692
00:22:29,166 --> 00:22:29,800
UNDERSTANDABLE.

693
00:22:29,800 --> 00:22:31,268
HOWEVER, FROM OUR PERSPECTIVE,

694
00:22:31,268 --> 00:22:32,602
THE FINANCIALS ARE JUST ONE PART

695
00:22:32,602 --> 00:22:35,305
OF THE PUZZLE, AND OFTEN IT'S

696
00:22:35,305 --> 00:22:36,273
THE NON-FINANCIAL TERMS THAT

697
00:22:36,273 --> 00:22:37,908
TAKE THE MOST TIME FOR US TO

698
00:22:37,908 --> 00:22:40,110
NEGOTIATE.

699
00:22:40,110 --> 00:22:41,645
DETERMINING THE SCOPE OF THE

700
00:22:41,645 --> 00:22:42,746
LICENSE GRANT WHICH COULD

701
00:22:42,746 --> 00:22:44,815
INCLUDE EXCLUSIVITY, THE

702
00:22:44,815 --> 00:22:47,017
TERRITORY, WHAT IP IS INCLUDED,

703
00:22:47,017 --> 00:22:48,985
STAGE OF DEVELOPMENT, WHAT

704
00:22:48,985 --> 00:22:51,488
PRODUCTS THE LICENSEE WILL

705
00:22:51,488 --> 00:22:55,892
COMMIT TO AND MORE AND ALSO A

706
00:22:55,892 --> 00:22:57,094
PRENON-DEVELOPMENT TIMELINE AND

707
00:22:57,094 --> 00:22:58,962
BENCHMARKS CAN BE COMPLICATED

708
00:22:58,962 --> 00:23:00,697
ESPECIALLY WHEN IT COMES TO AN

709
00:23:00,697 --> 00:23:01,164
EXCLUSIVE LICENSE.

710
00:23:01,164 --> 00:23:03,233
SO CAN THINGS LIKE REPORTING.

711
00:23:03,233 --> 00:23:04,334
ESPECIALLY WHEN IT COMES TO

712
00:23:04,334 --> 00:23:06,970
THINGS LIKE PRODUCT SALES, AND

713
00:23:06,970 --> 00:23:08,205
REQUIREMENTS ASSOCIATED WITH

714
00:23:08,205 --> 00:23:10,273
SUBLICENSING AND OTHER

715
00:23:10,273 --> 00:23:11,108
PARTNERSHIPS OUR LICENSEES MAY

716
00:23:11,108 --> 00:23:14,678
WANT TO ENTER INTO.

717
00:23:14,678 --> 00:23:15,912
THE NIH ALSO INCLUDES PUBLIC

718
00:23:15,912 --> 00:23:17,547
BENEFIT OR WHITE KNIGHT

719
00:23:17,547 --> 00:23:18,715
PROVISIONS TO ENCOURAGE THE

720
00:23:18,715 --> 00:23:20,951
LICENSEE TO FACILITATE ACCESS,

721
00:23:20,951 --> 00:23:23,320
EDUCATION AND FURTHER RESEARCH.

722
00:23:23,320 --> 00:23:25,889
THESE CAN BE A VARIETY OF THINGS

723
00:23:25,889 --> 00:23:27,257
LIKE PROVIDING PATIENT EDUCATION

724
00:23:27,257 --> 00:23:28,492
OR SUPPLYING PRODUCT FOR FURTHER

725
00:23:28,492 --> 00:23:33,463
RESEARCH.

726
00:23:33,463 --> 00:23:34,598
AND THEN I'M GOING TO COME BACK

727
00:23:34,598 --> 00:23:38,435
NOW TO MONITORING LICENSING

728
00:23:38,435 --> 00:23:39,169
PROGRESS.

729
00:23:39,169 --> 00:23:42,773
THIS IS A CRITICAL PART OF OUR

730
00:23:42,773 --> 00:23:45,942
BENEFIT TO -- WE DON'T KNOW IF

731
00:23:45,942 --> 00:23:47,043
OUR LICENSEES ARE ACTUALLY

732
00:23:47,043 --> 00:23:49,112
DEVELOPING THE TECHNOLOGIES,

733
00:23:49,112 --> 00:23:50,881
WE'RE NOT BEING GOOD STEWARTS OF

734
00:23:50,881 --> 00:23:51,548
OUR RESPONSIBILITIES.

735
00:23:51,548 --> 00:23:53,083
SO A LITTLE BIT MORE ABOUT THAT

736
00:23:53,083 --> 00:23:53,517
HERE.

737
00:23:53,517 --> 00:23:57,587
AS I'VE ALLUDED, IT'S A START OF

738
00:23:57,587 --> 00:23:58,989
A MULTIYEAR RELATIONSHIP BETWEEN

739
00:23:58,989 --> 00:23:59,990
NIH AND THE LICENSEE.

740
00:23:59,990 --> 00:24:03,693
THIS IS ONE PARTICULARLY FOR

741
00:24:03,693 --> 00:24:04,694
EARLY STAGE TECHNOLOGIES THAT

742
00:24:04,694 --> 00:24:07,464
CAN LAST 10 OR 15 YEARS OR EVEN

743
00:24:07,464 --> 00:24:08,331
LONGER.

744
00:24:08,331 --> 00:24:12,602
THERE ARE A LOT OF UNKNOWNS AND

745
00:24:12,602 --> 00:24:14,371
AT NIH WE CAN'T ASSUME ONCE THE

746
00:24:14,371 --> 00:24:15,672
BALL STARTS ROLLING IT WILL MAKE

747
00:24:15,672 --> 00:24:16,773
IT SUCCESS THRI DOWN THE ROAD TO

748
00:24:16,773 --> 00:24:17,841
THE DESTINATION AND THE PRODUCT

749
00:24:17,841 --> 00:24:20,277
THAT WE ARE HOPING TO SEE.

750
00:24:20,277 --> 00:24:21,812
THAT'S AN IMPORTANT REASON WHY

751
00:24:21,812 --> 00:24:24,681
WE REQUIRE A DEVELOPMENT PLAN,

752
00:24:24,681 --> 00:24:25,882
BENCHMARKS AND REPORTING BY THE

753
00:24:25,882 --> 00:24:27,083
LICENSEE SO THAT WE CAN SEE

754
00:24:27,083 --> 00:24:29,386
WHETHER THE LICENSEE IS ON TRACK

755
00:24:29,386 --> 00:24:31,121
OR NOT, AND WHETHER THAT'S DUE

756
00:24:31,121 --> 00:24:33,423
TO A LACK OF DILIGENCE ON THE

757
00:24:33,423 --> 00:24:34,524
LICENSEE'S PART OR FROM OTHER

758
00:24:34,524 --> 00:24:36,593
FACTORS THAT MAY BE OUTSIDE THE

759
00:24:36,593 --> 00:24:39,796
LICENSEE'S CONTROL.

760
00:24:39,796 --> 00:24:41,198
FINDING POTENTIAL PROBLEMS EARLY

761
00:24:41,198 --> 00:24:42,632
MEANS THEY'RE EASIER TO RESOLVE,

762
00:24:42,632 --> 00:24:43,934
AND WE DO WORK WITH OUR

763
00:24:43,934 --> 00:24:45,702
LICENSEES TO RESOLVE PROBLEMS IF

764
00:24:45,702 --> 00:24:46,570
WE CAN.

765
00:24:46,570 --> 00:24:48,772
WE ACTUALLY HAVE AN ENTIRE GROUP

766
00:24:48,772 --> 00:24:50,740
AT THE NIH OFFICE OF TECHNOLOGY

767
00:24:50,740 --> 00:24:52,275
TRANSFER THAT'S DEDICATED TO

768
00:24:52,275 --> 00:24:53,844
REVIEWING EXECUTED LICENSES TO

769
00:24:53,844 --> 00:24:57,581
MAKE SURE THAT OUR LICENSEES ARE

770
00:24:57,581 --> 00:24:58,982
COMPLIANT WITH THEIR TERMS AND

771
00:24:58,982 --> 00:25:00,217
MAKING GOOD PROGRESS.

772
00:25:00,217 --> 00:25:02,619
OUR SPECIALISTS EXAMINE PROGRESS

773
00:25:02,619 --> 00:25:05,021
REPORTS, BENCHMARKS, PAYMENT

774
00:25:05,021 --> 00:25:08,425
HISTORY, PUBLISHED INFORMATION,

775
00:25:08,425 --> 00:25:09,192
OTHER PUBLIC INFORMATION

776
00:25:09,192 --> 00:25:10,961
PROVIDED BY THE LICENSEE, AS

777
00:25:10,961 --> 00:25:12,262
WELL AS DISCUSSING PROGRESS WITH

778
00:25:12,262 --> 00:25:13,263
THE LICENSEE.

779
00:25:13,263 --> 00:25:14,898
IF THE LICENSEE IS NOT

780
00:25:14,898 --> 00:25:16,066
PERFORMING, WE HAVE A NUMBER OF

781
00:25:16,066 --> 00:25:17,934
LEVERS THAT WE CAN USE.

782
00:25:17,934 --> 00:25:20,003
BUT ALWAYS FOCUSING ON OUR END

783
00:25:20,003 --> 00:25:22,005
GOAL, WHICH IS WHAT'S BEST FOR

784
00:25:22,005 --> 00:25:23,173
GETTING OUR TECHNOLOGIES OUT TO

785
00:25:23,173 --> 00:25:27,477
BENEFIT THE PUBLIC.

786
00:25:27,477 --> 00:25:29,546
WITH THAT, I'M GOING TO TURN THE

787
00:25:29,546 --> 00:25:31,047
DISCUSSION OVER TO MY COLLEAGUE,

788
00:25:31,047 --> 00:25:34,017
ABBY RIVES, NOW THAT HOPEFULLY

789
00:25:34,017 --> 00:25:35,018
THERE'S SOME BACKGROUND AND

790
00:25:35,018 --> 00:25:36,753
CONTEXT ABOUT OUR IRP LICENSING

791
00:25:36,753 --> 00:25:38,288
PROGRAM, WILL TALK ABOUT THE

792
00:25:38,288 --> 00:25:39,022
PROPOSED POLICY.

793
00:25:39,022 --> 00:25:40,490
OVER TO YOU, ABBY.

794
00:25:40,490 --> 00:25:43,560
>> THANKS VERY MUCH, TARA.

795
00:25:43,560 --> 00:25:46,196
I'LL JUST REITERATE WHAT LYRIC

796
00:25:46,196 --> 00:25:47,631
AND TARA HAVE ALREADY SAID,

797
00:25:47,631 --> 00:25:48,932
THANKS TO ALL OF YOU WHO ARE

798
00:25:48,932 --> 00:25:49,799
JOINING THIS WEBINAR.

799
00:25:49,799 --> 00:25:50,834
WE'RE GRATEFUL FOR YOUR INTEREST

800
00:25:50,834 --> 00:25:53,203
IN THIS TOPIC AND LOOK FORWARD

801
00:25:53,203 --> 00:25:55,272
TO HEARING FROM YOU IN THE

802
00:25:55,272 --> 00:25:56,606
FUTURE.

803
00:25:56,606 --> 00:25:59,209
SO I AM GOING TO TALK ABOUT THE

804
00:25:59,209 --> 00:26:00,977
REQUEST FOR INFORMATION THAT NIH

805
00:26:00,977 --> 00:26:02,846
PUBLISHED LATE LAST MONTH, BUT

806
00:26:02,846 --> 00:26:05,782
BEFORE WE DIVE INTO THOSE

807
00:26:05,782 --> 00:26:06,549
DETAILS, WE THOUGHT IT MIGHT

808
00:26:06,549 --> 00:26:08,518
HELP TO UNPACK WHAT PEOPLE MEAN

809
00:26:08,518 --> 00:26:09,953
WHEN THEY TALK ABOUT ACCESS

810
00:26:09,953 --> 00:26:11,321
PLANNING.

811
00:26:11,321 --> 00:26:13,990
AND I USE THIS SIMPLISTIC

812
00:26:13,990 --> 00:26:15,725
DIAGRAM TO HELP ILLUSTRATE THAT

813
00:26:15,725 --> 00:26:16,960
IDEA.

814
00:26:16,960 --> 00:26:18,695
SO THE BASIC IDEA OF ACCESS

815
00:26:18,695 --> 00:26:21,197
PLANNING INVOLVES INCORPORATING

816
00:26:21,197 --> 00:26:24,968
PATIENT ACCESS CONSIDERATIONS AT

817
00:26:24,968 --> 00:26:27,904
A HIGH LEVEL IN' AGREEMENTS

818
00:26:27,904 --> 00:26:30,473
RELATED TO BIOMEDICAL RESEARCH

819
00:26:30,473 --> 00:26:31,107
AND DEVELOPMENT.

820
00:26:31,107 --> 00:26:33,843
A PATENT LICENSE HERE AT THIS

821
00:26:33,843 --> 00:26:34,811
POINT IN TIME DURING THE

822
00:26:34,811 --> 00:26:35,812
PRE-CLINICAL STAGE OF

823
00:26:35,812 --> 00:26:37,547
DEVELOPMENT OR EVEN EARLIER

824
00:26:37,547 --> 00:26:39,849
MIGHT REQUIRE A LICENSEE TO

825
00:26:39,849 --> 00:26:42,819
SUBMIT A PATIENT ACCESS PLAN IF

826
00:26:42,819 --> 00:26:46,323
AND WHEN THE LICENSEE GET TO A

827
00:26:46,323 --> 00:26:47,824
CERTAIN LATER POINT IN PRODUCT

828
00:26:47,824 --> 00:26:48,925
DEVELOPMENT.

829
00:26:48,925 --> 00:26:50,894
THE INITIAL LICENSE WOULD NOT

830
00:26:50,894 --> 00:26:52,829
INCLUDE ALL THE DETAILS ABOUT

831
00:26:52,829 --> 00:26:56,800
HOW THE LICENSEE WILL PROMOTE

832
00:26:56,800 --> 00:26:57,033
ACCESS.

833
00:26:57,033 --> 00:26:59,302
INSTEAD, THOSE AGREEMENTS -- IN

834
00:26:59,302 --> 00:27:00,503
THOSE AGREEMENTS, THE PARTIES

835
00:27:00,503 --> 00:27:04,474
WILL COMMIT TO REVISITING ACCESS

836
00:27:04,474 --> 00:27:07,544
SO THE INITIAL AGREEMENT TERMS

837
00:27:07,544 --> 00:27:09,412
WOULD BE INTENTIONALLY FLEXIBLE

838
00:27:09,412 --> 00:27:11,481
AND NOT PRESCRIPTIVE, AND IF

839
00:27:11,481 --> 00:27:13,750
PRODUCT DEVELOPMENT IS

840
00:27:13,750 --> 00:27:15,085
SUCCESSFUL, THEN AND ONLY THEN

841
00:27:15,085 --> 00:27:17,053
WOULD A LICENSEE DEVELOP AND

842
00:27:17,053 --> 00:27:19,255
SUBMIT THEIR ACCESS PLAN.

843
00:27:19,255 --> 00:27:20,557
THAT LATER PLAN WOULD INCLUDE

844
00:27:20,557 --> 00:27:21,891
MORE OF THE DETAILED

845
00:27:21,891 --> 00:27:22,859
CONSIDERATIONS AROUND PROMOTING

846
00:27:22,859 --> 00:27:27,364
ACCESS.

847
00:27:27,364 --> 00:27:28,999
THIS ALSO ALLOWS ACCESS PLANNING

848
00:27:28,999 --> 00:27:30,066
WORK DONE IN COORDINATION

849
00:27:30,066 --> 00:27:31,301
BETWEEN THE PARTIES BETWEEN THE

850
00:27:31,301 --> 00:27:32,435
PATENT OWNER AND THE LICENSEE,

851
00:27:32,435 --> 00:27:34,137
AND YOU COULD ANALOGIZE THIS

852
00:27:34,137 --> 00:27:35,905
APPROACH TO ACCESS PLANNING TO

853
00:27:35,905 --> 00:27:37,440
SOME OF THE COMMERCIAL

854
00:27:37,440 --> 00:27:38,842
DEVELOPMENT PLANNING THAT TARA

855
00:27:38,842 --> 00:27:40,944
JUST SPOKE ABOUT ELSEWHERE IN

856
00:27:40,944 --> 00:27:47,917
BIOMEDICAL R & D LICENSES.

857
00:27:47,917 --> 00:27:52,088
THIS ISN'T AN ENTIRELY NEW IDEA,

858
00:27:52,088 --> 00:27:55,158
SIMILAR VERSIONS OF ACCESS

859
00:27:55,158 --> 00:27:56,126
PLANNING ALREADY AND DIFFERENT

860
00:27:56,126 --> 00:27:56,693
INSTITUTIONS ARE TAKING

861
00:27:56,693 --> 00:27:57,494
DIFFERENT APPROACHES.

862
00:27:57,494 --> 00:27:58,561
IF YOU'RE INTERESTED IN STARTING

863
00:27:58,561 --> 00:28:00,163
TO LEARN A LITTLE BIT MORE, THIS

864
00:28:00,163 --> 00:28:02,165
IS A TOPIC THAT WAS DISCUSSED

865
00:28:02,165 --> 00:28:05,001
DURING AN NIH WORKSHOP LAST

866
00:28:05,001 --> 00:28:06,970
JULY, AND THE REPORT HERE ON THE

867
00:28:06,970 --> 00:28:09,272
NIH OSP WEBSITE ALONG WITH A

868
00:28:09,272 --> 00:28:12,042
WEBCAST OF THAT WORKSHOP ARE

869
00:28:12,042 --> 00:28:13,209
AVAILABLE ONLINE, SUMMARIZING IN

870
00:28:13,209 --> 00:28:15,512
PART THE BASIC IDEA AND

871
00:28:15,512 --> 00:28:17,380
INCLUDING SOME LINKS TO SOME

872
00:28:17,380 --> 00:28:18,348
RELEVANT BACKGROUND MATERIALS

873
00:28:18,348 --> 00:28:20,550
AND PERSPECTIVES FROM SOME OTHER

874
00:28:20,550 --> 00:28:22,385
FOLKS ON THIS TOPIC.

875
00:28:22,385 --> 00:28:26,356
SO WITH THAT CONTEXT IN PLACE,

876
00:28:26,356 --> 00:28:28,425
AS YOU ALL KNOW, LATE LAST

877
00:28:28,425 --> 00:28:30,727
MONTH, NIH RELEASED THIS INITIAL

878
00:28:30,727 --> 00:28:34,330
POLICY PROPOSAL DRAFT AND A

879
00:28:34,330 --> 00:28:35,632
REQUEST FOR INFORMATION ABOUT

880
00:28:35,632 --> 00:28:37,400
INCORPORATING PATIENT ACCESS

881
00:28:37,400 --> 00:28:39,903
PLANNING INTO OUR INTRAMURAL

882
00:28:39,903 --> 00:28:41,771
PROGRAM'S PATENT LICENSES.

883
00:28:41,771 --> 00:28:43,173
AS LYRIC MENTIONED, WE'RE HERE

884
00:28:43,173 --> 00:28:44,741
AT THE RFI STAGE.

885
00:28:44,741 --> 00:28:47,143
WE AS AN AGENCY ARE VERY EAGER

886
00:28:47,143 --> 00:28:48,645
TO HEAR PERSPECTIVES FROM THE

887
00:28:48,645 --> 00:28:50,313
PUBLIC ON THIS DRAFT POLICY AND

888
00:28:50,313 --> 00:28:51,714
WE'RE INTERESTED IN YOUR

889
00:28:51,714 --> 00:28:53,583
FEEDBACK ON THE QUESTIONS POSED

890
00:28:53,583 --> 00:28:56,953
IN THE RFI.

891
00:28:56,953 --> 00:28:59,956
SO TURNING TO WHAT IS IN THAT

892
00:28:59,956 --> 00:29:01,391
RFI, AND OUR GOAL HERE WAS

893
00:29:01,391 --> 00:29:02,892
PROVIDING THIS INFORMATION AS TO

894
00:29:02,892 --> 00:29:03,860
HOPEFULLY FACILITATE YOUR

895
00:29:03,860 --> 00:29:06,863
PARTICIPATION IN THE PROCESS, SO

896
00:29:06,863 --> 00:29:08,498
THIS IS A HIGH LEVEL SUMMARY OF

897
00:29:08,498 --> 00:29:12,869
WHAT'S PROPOSED IN THE DRAFT

898
00:29:12,869 --> 00:29:13,670
POLICY AND RFI.

899
00:29:13,670 --> 00:29:15,405
WE WOULD DEVELOP THROUGH OUR

900
00:29:15,405 --> 00:29:16,439
INTRAMURAL PATENT LICENSING

901
00:29:16,439 --> 00:29:18,141
PROGRAM A NEW POLICY TO PROMOTE

902
00:29:18,141 --> 00:29:19,676
ACCESS TO PRODUCTS THAT STEM

903
00:29:19,676 --> 00:29:23,646
FROM OUR IRP NIH-OWNED

904
00:29:23,646 --> 00:29:23,980
INVENTIONS.

905
00:29:23,980 --> 00:29:25,648
IT WOULD INVOLVE INCORPORATING

906
00:29:25,648 --> 00:29:29,152
EXPLICIT PATIENT ACCESS PLANNING

907
00:29:29,152 --> 00:29:30,353
EARLIER IN THE COMMERCIALIZATION

908
00:29:30,353 --> 00:29:31,588
PROCESS, AND IT WOULD INVOLVE

909
00:29:31,588 --> 00:29:33,123
THE AGENCY WORKING WITH OUR

910
00:29:33,123 --> 00:29:35,291
PATENT LICENSEE ON OUR SHARED

911
00:29:35,291 --> 00:29:37,694
PUBLIC HEALTH GOALS.

912
00:29:37,694 --> 00:29:38,795
PRACTICALLY SPEAKING, WHAT WE

913
00:29:38,795 --> 00:29:40,530
ARE PROPOSING AND WHAT IT WOULD

914
00:29:40,530 --> 00:29:43,967
LOOK LIKE WOULD BE ADDING NEW

915
00:29:43,967 --> 00:29:45,568
LANGUAGE TO SOME OF OUR MODEL

916
00:29:45,568 --> 00:29:46,669
PATENT LICENSE AGREEMENTS.

917
00:29:46,669 --> 00:29:47,971
THOSE MODEL AGREEMENTS ARE

918
00:29:47,971 --> 00:29:50,840
POSTED ALREADY ON THE NIH

919
00:29:50,840 --> 00:29:52,041
TECHNOLOGY TRANSFER COMMUNITY

920
00:29:52,041 --> 00:29:54,344
WEBSITE, AND THEY SERVE AS THE

921
00:29:54,344 --> 00:29:57,080
BASIS FOR LICENSE NEGOTIATIONS,

922
00:29:57,080 --> 00:29:58,615
SO I'LL TURN TO WHAT SPECIFICS

923
00:29:58,615 --> 00:30:01,384
OF THIS MIGHT LOOK LIKE IN A

924
00:30:01,384 --> 00:30:02,986
SECOND IN THE NUTS AND BOLTS OF

925
00:30:02,986 --> 00:30:07,390
THE DRAFT PROPOSED POLICY.

926
00:30:07,390 --> 00:30:09,058
SO STARTING WITH THE SCOPE, THE

927
00:30:09,058 --> 00:30:10,360
PROPOSED POLICY SCOPE IS

928
00:30:10,360 --> 00:30:16,132
RELATIVELY STRAIGHTFORWARD.

929
00:30:16,132 --> 00:30:16,866
ENCOMPASSED IN THE RFI, THIS

930
00:30:16,866 --> 00:30:18,001
WOULD BE A POLICY THAT WOULD

931
00:30:18,001 --> 00:30:20,403
APPLY TO LICENSES, AGAIN, THAT

932
00:30:20,403 --> 00:30:22,305
ORIGINATE FROM THE NIH

933
00:30:22,305 --> 00:30:23,072
INTRAMURAL PROGRAM.

934
00:30:23,072 --> 00:30:26,476
IT WOULD APPLY TO COMMERCIAL

935
00:30:26,476 --> 00:30:27,877
THAT TENT LICENSES AND MORE

936
00:30:27,877 --> 00:30:29,612
SPECIFICALLY TO THOSE LICENSES

937
00:30:29,612 --> 00:30:31,481
THAT AUTHORIZE COMMERCIALIZATION

938
00:30:31,481 --> 00:30:34,684
OF DRUG BIOLOGICS, VACCINES OR

939
00:30:34,684 --> 00:30:37,487
DEVICES IN CONTRAST TO, FOR

940
00:30:37,487 --> 00:30:39,489
EXAMPLE, WHAT TARA MENTIONED,

941
00:30:39,489 --> 00:30:40,924
LICENSES THAT WOULD AUTHORIZE

942
00:30:40,924 --> 00:30:44,594
USE OF CERTAIN RESEARCH TOOLS.

943
00:30:44,594 --> 00:30:47,997
AND THE POLICY WOULD APPLY TO

944
00:30:47,997 --> 00:30:50,166
LICENSES THAT SPAN NON-EXCLUSIVE

945
00:30:50,166 --> 00:30:51,935
TO EXCLUSIVE.

946
00:30:51,935 --> 00:30:55,205
A NOTE THAT WE ARE IT BE I CONTO

947
00:30:55,205 --> 00:30:56,839
EXPLORE WHETHER AND HOW THIS

948
00:30:56,839 --> 00:30:58,308
POLICY MIGHT APPLY TO JOINTLY

949
00:30:58,308 --> 00:30:59,342
OWNED INVENTIONS, SO APPLICATION

950
00:30:59,342 --> 00:31:00,910
OF THE PROPOSED POLICY TO

951
00:31:00,910 --> 00:31:02,912
PATENTS THAT ARE JOINTLY OWNED

952
00:31:02,912 --> 00:31:05,315
BY NIH WILL BE CONSIDERED AT A

953
00:31:05,315 --> 00:31:07,383
LATER DATE, AND THIS POLICY

954
00:31:07,383 --> 00:31:10,653
WOULD NOT REACH THE I.P. THAT

955
00:31:10,653 --> 00:31:12,755
OUR LICENSEES DEVELOP ON THEIR

956
00:31:12,755 --> 00:31:14,691
OWN OR I.P. THAT OUR PARTNERS

957
00:31:14,691 --> 00:31:16,359
BRING INTO COLLABORATION.

958
00:31:16,359 --> 00:31:19,128
PUT ANOTHER WAY, PATENTS OWNED

959
00:31:19,128 --> 00:31:21,097
SOLELY BY NIH'S COLLABORATORS

960
00:31:21,097 --> 00:31:22,832
AND PARTNERS WOULD BE OUTSIDE

961
00:31:22,832 --> 00:31:26,169
THE SCOPE OF THIS POLICY.

962
00:31:26,169 --> 00:31:28,571
HERE IS THE DRAFT LANGUAGE FROM

963
00:31:28,571 --> 00:31:30,840
THE RFI, AND AS I MENTIONED, NIH

964
00:31:30,840 --> 00:31:32,809
WOULD ADD LANGUAGE LIKE THIS TO

965
00:31:32,809 --> 00:31:34,577
THE MODEL AGREEMENTS THAT ARE

966
00:31:34,577 --> 00:31:38,314
WITHIN THE SCOPE OF THE POLICY.

967
00:31:38,314 --> 00:31:39,315
I'M NOT GOING TO BORE YOU WITH

968
00:31:39,315 --> 00:31:40,717
ALL THE DETAILS HERE, BUT I DID

969
00:31:40,717 --> 00:31:42,452
WANT TO HIGHLIGHT JUST A FEW

970
00:31:42,452 --> 00:31:44,320
PIECES THAT YOU CAN GLEAN FROM

971
00:31:44,320 --> 00:31:45,521
THIS LANGUAGE.

972
00:31:45,521 --> 00:31:47,190
WITH THIS LANGUAGE, NIH WOULD

973
00:31:47,190 --> 00:31:51,794
ASK OUR LICENSEES TO SEND US

974
00:31:51,794 --> 00:31:52,996
ACCESS PLAN.

975
00:31:52,996 --> 00:31:54,297
THE ACCESS PLAN WOULD ADDRESS

976
00:31:54,297 --> 00:31:55,531
STRATEGIES TO SUPPORT PATIENT

977
00:31:55,531 --> 00:31:57,267
ACCESS BROADLY IN THE UNITED

978
00:31:57,267 --> 00:31:59,469
STATES, AND WE CALL OUT A FOCUS

979
00:31:59,469 --> 00:32:02,739
ON UNDERSERVED DOMESTIC AND/OR

980
00:32:02,739 --> 00:32:04,374
GLOBAL POPULATIONS AS WELL.

981
00:32:04,374 --> 00:32:05,842
THAT ACCESS PLAN WOULDN'T BE DUE

982
00:32:05,842 --> 00:32:08,444
UNTIL THE LICENSEE HAS A PRODUCT

983
00:32:08,444 --> 00:32:12,148
IN PIVOTAL CLINICAL TRIAL, PHASE

984
00:32:12,148 --> 00:32:14,250
THREE OR THE EQUIVALENT.

985
00:32:14,250 --> 00:32:15,752
THIS LANGUAGE ALSO DEFINES WHAT

986
00:32:15,752 --> 00:32:18,054
AN ACCESS PLAN IS.

987
00:32:18,054 --> 00:32:20,256
AND THE LANGUAGE ENVISIONS

988
00:32:20,256 --> 00:32:21,291
FLEXIBILITY.

989
00:32:21,291 --> 00:32:22,925
IT ENVISIONS OPPORTUNITIES FOR

990
00:32:22,925 --> 00:32:25,561
NIH TO WORK WITH OUR LICENSEES

991
00:32:25,561 --> 00:32:27,530
AND THAT COULD INVOLVE NIH

992
00:32:27,530 --> 00:32:30,066
WORKING WITH OUR LICENSEES TO

993
00:32:30,066 --> 00:32:31,367
CONFER ABOUT WHAT GOES INTO AN

994
00:32:31,367 --> 00:32:34,137
ACCESS PLAN.

995
00:32:34,137 --> 00:32:37,407
THIS LANGUAGE ALSO INCLUDES A

996
00:32:37,407 --> 00:32:39,375
PROVISION FOR LICENSEES TO SEEK

997
00:32:39,375 --> 00:32:41,144
WAIVERS.

998
00:32:41,144 --> 00:32:43,413
WE ANTICIPATE THAT THESE

999
00:32:43,413 --> 00:32:47,150
PROCESSES COULD MIRROR THE WAY

1000
00:32:47,150 --> 00:32:49,152
NIH ALREADY WORKS WITH OUR

1001
00:32:49,152 --> 00:32:50,787
LICENSEES ON OTHER REQUIREMENTS

1002
00:32:50,787 --> 00:32:52,288
TARA MENTIONED LIKE DEVELOPMENT

1003
00:32:52,288 --> 00:32:53,323
MILESTONES, PROGRESS REPORTS AND

1004
00:32:53,323 --> 00:32:57,927
OTHER LICENSING REQUIREMENTS.

1005
00:32:57,927 --> 00:33:00,897
BEFORE WE FINALIZE ANY ACCESS

1006
00:33:00,897 --> 00:33:04,834
PLANNING POLICY, NIH PROPOSES TO

1007
00:33:04,834 --> 00:33:06,035
DEVELOP GUIDANCE FOR ACCESS

1008
00:33:06,035 --> 00:33:07,437
PLANS.

1009
00:33:07,437 --> 00:33:09,205
THIS COULD INCLUDE AN ACCESS

1010
00:33:09,205 --> 00:33:11,040
PLAN TEMPLATE THIS OUR LICENSEES

1011
00:33:11,040 --> 00:33:13,142
COULD FILL OUT.

1012
00:33:13,142 --> 00:33:15,211
DRAWING FROM LANGUAGE ON THE

1013
00:33:15,211 --> 00:33:17,613
PREVIOUS SLIDE AND THE MODEL

1014
00:33:17,613 --> 00:33:20,350
LANGUAGE OF THE -- THE DRAFT

1015
00:33:20,350 --> 00:33:21,951
LANGUAGE FOR MODEL AGREEMENTS,

1016
00:33:21,951 --> 00:33:22,985
HERE ARE THE LIST OF THINGS

1017
00:33:22,985 --> 00:33:24,320
WE'RE PROPOSING FOR EVERY ACCESS

1018
00:33:24,320 --> 00:33:27,357
PLAN TO INCLUDE.

1019
00:33:27,357 --> 00:33:29,325
FIRST A DESCRIPTION OF THE

1020
00:33:29,325 --> 00:33:31,461
PRODUCT, IDENTIFICATION OF THE

1021
00:33:31,461 --> 00:33:37,567
ANTICIPATED PATIENT POPULATION,

1022
00:33:37,567 --> 00:33:38,401
THE THIRD BULLET POINT ABOUT

1023
00:33:38,401 --> 00:33:39,769
OTHER PRODUCTS, TOOLS,

1024
00:33:39,769 --> 00:33:41,404
FACILITIES OR UNIQUE RESOURCES

1025
00:33:41,404 --> 00:33:43,573
NECESSARY TO USE A PRODUCT.

1026
00:33:43,573 --> 00:33:45,041
WE'VE INCLUDED THIS IN

1027
00:33:45,041 --> 00:33:46,342
RECOGNITION OF THE FACT THAT A

1028
00:33:46,342 --> 00:33:48,444
LOT OF FEATURES OF ACCESS ARE

1029
00:33:48,444 --> 00:33:51,180
OUTSIDE THE LICENSEES' CONTROL.

1030
00:33:51,180 --> 00:33:53,383
FOR EXAMPLE, OUR ACCESS TO A

1031
00:33:53,383 --> 00:33:55,651
GIVEN PRODUCT MIGHT HINGE ON

1032
00:33:55,651 --> 00:33:57,653
OTHER HEALTHCARE INFRASTRUCTURE,

1033
00:33:57,653 --> 00:33:59,822
OR A PATIENT MIGHT NEED ACCESS

1034
00:33:59,822 --> 00:34:01,791
TO A CERTAIN DIAGNOSIS BEFORE

1035
00:34:01,791 --> 00:34:03,960
RECEIVING A TREATMENT, BUT

1036
00:34:03,960 --> 00:34:05,294
ACCESS TO THAT DIAGNOSTIC MIGHT

1037
00:34:05,294 --> 00:34:06,796
BE OUTSIDE OF THE LICENSEE'S

1038
00:34:06,796 --> 00:34:10,299
CONTROL.

1039
00:34:10,299 --> 00:34:11,234
LICENSEES COULD NOTE SOME OF

1040
00:34:11,234 --> 00:34:13,102
THESE OTHER FEATURES IN AN

1041
00:34:13,102 --> 00:34:14,137
ACCESS PLAN BECAUSE WE RECOGNIZE

1042
00:34:14,137 --> 00:34:15,838
THAT THERE MAY BE EXTERNAL

1043
00:34:15,838 --> 00:34:17,039
CHALLENGES TO PATIENT ACCESS,

1044
00:34:17,039 --> 00:34:19,475
AND WE CAN FACTOR THOSE INTO OUR

1045
00:34:19,475 --> 00:34:21,778
CONVERSATION HERE.

1046
00:34:21,778 --> 00:34:24,213
WE ALSO THINK THAT EXPLORING

1047
00:34:24,213 --> 00:34:25,748
THESE OTHER FEATURES THAT IMPACT

1048
00:34:25,748 --> 00:34:28,117
ACCESS AND HAVING THESE

1049
00:34:28,117 --> 00:34:31,187
CONVERSATIONS AT THE AGENCY CAN

1050
00:34:31,187 --> 00:34:32,989
ALLOW NIH AND OUR PARTNERS

1051
00:34:32,989 --> 00:34:34,524
ACROSS THE BOARD TO APPROACH

1052
00:34:34,524 --> 00:34:35,491
THINKING ABOUT ACCESS FROM

1053
00:34:35,491 --> 00:34:36,559
UNIQUE ANGLES AS WELL.

1054
00:34:36,559 --> 00:34:38,127
FOR EXAMPLE, WE CAN ALSO BE

1055
00:34:38,127 --> 00:34:39,962
THINKING ABOUT PRODUCT DESIGN

1056
00:34:39,962 --> 00:34:41,931
CHOICES, DIRECTIONS FOR FUTURE

1057
00:34:41,931 --> 00:34:45,034
R & D, OR FUTURE

1058
00:34:45,034 --> 00:34:47,103
COMMERCIALIZATION OPPORTUNITIES

1059
00:34:47,103 --> 00:34:48,638
TO DEVELOP PRODUCTS THAT MEET

1060
00:34:48,638 --> 00:34:51,841
MORE PATIENTS WHERE THEY ARE AT.

1061
00:34:51,841 --> 00:34:53,709
RELATEDLY AS PART OF THE RFI AND

1062
00:34:53,709 --> 00:34:55,578
THE DRAFT PROPOSED ACCESS

1063
00:34:55,578 --> 00:34:58,181
PLANNING POLICY, WE ARE

1064
00:34:58,181 --> 00:34:59,615
INTERESTED IN HEARING INPUT ON

1065
00:34:59,615 --> 00:35:02,118
WHAT NIH AND THE GOVERNMENT CAN

1066
00:35:02,118 --> 00:35:04,020
DO TO HELP OUR LICENSEES ACHIEVE

1067
00:35:04,020 --> 00:35:05,855
ACCESS GOALS.

1068
00:35:05,855 --> 00:35:07,056
THERE MAY BE EXISTING PROGRAMS

1069
00:35:07,056 --> 00:35:09,459
WE CAN PLUG INTO TO MITIGATE

1070
00:35:09,459 --> 00:35:11,961
EXTERNAL ACCESS CHALLENGES.

1071
00:35:11,961 --> 00:35:14,163
AND THEN FINALLY, ACCESS PLANS

1072
00:35:14,163 --> 00:35:15,698
WOULD CONTAIN ONE OR MORE

1073
00:35:15,698 --> 00:35:18,100
STRATEGIES TO MITIGATE THOSE

1074
00:35:18,100 --> 00:35:22,305
ACCESS CHALLENGES.

1075
00:35:22,305 --> 00:35:24,040
AS PAR OF THE ACCESS PLANNING

1076
00:35:24,040 --> 00:35:26,476
GUIDANCE NIH IS PROPOSING, WE

1077
00:35:26,476 --> 00:35:28,444
WOULD ALSO INCLUDE A LIST OF

1078
00:35:28,444 --> 00:35:30,613
IDEAS OR MANY EXAMPLES, IF YOU

1079
00:35:30,613 --> 00:35:32,615
WILL, OF STRATEGIES THAT

1080
00:35:32,615 --> 00:35:34,250
LICENSEES CAN SELECT TO INCREASE

1081
00:35:34,250 --> 00:35:37,687
EQUITABLE ACCESS.

1082
00:35:37,687 --> 00:35:39,188
AT THE RFI STAGE, THIS IS

1083
00:35:39,188 --> 00:35:39,956
CERTAINLY ONE OF THE AREAS THAT

1084
00:35:39,956 --> 00:35:41,824
WE'VE REALLY CALLED OUT FOR

1085
00:35:41,824 --> 00:35:42,592
PUBLIC INPUT.

1086
00:35:42,592 --> 00:35:44,026
WE'RE EAGER TO HEAR YOUR IDEAS

1087
00:35:44,026 --> 00:35:45,561
ABOUT STRATEGIES TO EXPAND THE

1088
00:35:45,561 --> 00:35:49,365
REACH AND THE BENEFIT OF NEW

1089
00:35:49,365 --> 00:35:50,700
BIOMEDICAL PRODUCTS.

1090
00:35:50,700 --> 00:35:53,302
THE PERSPECTIVES THAT YOU SHARE

1091
00:35:53,302 --> 00:35:54,904
COULD HELP SHAPE THIS INTO A

1092
00:35:54,904 --> 00:35:56,706
MORE COMPREHENSIVE AND CONCRETE

1093
00:35:56,706 --> 00:35:58,574
LIST, AND THIS IS A TOPIC THAT

1094
00:35:58,574 --> 00:36:01,210
NIH CAN ALSO CONTINUE TO REVISIT

1095
00:36:01,210 --> 00:36:03,312
AS NEW IDEAS AND STRATEGIES

1096
00:36:03,312 --> 00:36:08,985
EMERGE OVER THE COMING YEARS.

1097
00:36:08,985 --> 00:36:10,486
AMONG THE IDEAS WE INCLUDED IN

1098
00:36:10,486 --> 00:36:11,854
THE RFI, THE FIRST ONE LISTED

1099
00:36:11,854 --> 00:36:13,289
HERE, PARTNERING WITH PUBLIC

1100
00:36:13,289 --> 00:36:14,924
HEALTH, NON-PROFIT OR PATIENT

1101
00:36:14,924 --> 00:36:18,427
ADVOCACY ORGANIZATIONS, EXAMPLES

1102
00:36:18,427 --> 00:36:19,629
OF THIS MIGHT INCLUDE

1103
00:36:19,629 --> 00:36:21,063
PARTNERSHIPS DURING RESEARCH AND

1104
00:36:21,063 --> 00:36:22,265
DEVELOPMENT, PARTNERSHIPS DURING

1105
00:36:22,265 --> 00:36:24,700
REGULATORY APPROVAL, OR THE

1106
00:36:24,700 --> 00:36:26,669
POINT OF SALES AND MARKETING.

1107
00:36:26,669 --> 00:36:27,970
IT COULD INCLUDE SELLING

1108
00:36:27,970 --> 00:36:29,171
LICENSED PRODUCTS TO PARTNER

1109
00:36:29,171 --> 00:36:30,406
ORGANIZATIONS THAT TREAT

1110
00:36:30,406 --> 00:36:31,641
UNDERSERVED POPULATIONS.

1111
00:36:31,641 --> 00:36:33,342
OR IT MIGHT INVOLVE PARTNERING

1112
00:36:33,342 --> 00:36:36,012
TO LICENSE INTELLECTUAL PROPERTY

1113
00:36:36,012 --> 00:36:37,313
TO PUBLIC HEALTH PATENT POOLS.

1114
00:36:37,313 --> 00:36:38,748
AGAIN, THOSE ARE JUST SOME

1115
00:36:38,748 --> 00:36:39,815
EXAMPLES OR IDEAS THAT COULD

1116
00:36:39,815 --> 00:36:42,051
FALL UNDER THIS FIRST PROPOSED

1117
00:36:42,051 --> 00:36:43,686
POTENTIAL STRATEGY FOR EXPANDING

1118
00:36:43,686 --> 00:36:47,823
REACH AND BENEFIT OF PRODUCT.

1119
00:36:47,823 --> 00:36:49,025
THE SECOND BULLET HERE

1120
00:36:49,025 --> 00:36:49,992
ADDRESSING ACCESSIBILITY AS A

1121
00:36:49,992 --> 00:36:53,296
DESIGN OBJECTIVE.

1122
00:36:53,296 --> 00:36:54,530
EXAMPLES COULD INCLUDE

1123
00:36:54,530 --> 00:36:56,265
CONDUCTING PATIENT INTERVIEWS OR

1124
00:36:56,265 --> 00:36:59,268
NEED ASSESSMENT EARLY IN PRODUCT

1125
00:36:59,268 --> 00:37:02,104
DEVELOPMENT FOR STRATEGICALLY

1126
00:37:02,104 --> 00:37:04,173
MAKING CHOICES ORIENTED TOWARDS

1127
00:37:04,173 --> 00:37:06,809
PROMOTING PATIENT ACCESS.

1128
00:37:06,809 --> 00:37:09,445
THIRD ON THIS LIST, COMMITTING

1129
00:37:09,445 --> 00:37:11,013
TO SUBLICENSE RELEVANT

1130
00:37:11,013 --> 00:37:12,214
INTELLECTUAL PROPERTY AND

1131
00:37:12,214 --> 00:37:12,882
KNOW-HOW.

1132
00:37:12,882 --> 00:37:14,083
SOME OF THE EXAMPLES WE

1133
00:37:14,083 --> 00:37:15,718
MENTIONED IN THE RFI HERE COULD

1134
00:37:15,718 --> 00:37:18,354
INCLUDE SUBLICENSING TO

1135
00:37:18,354 --> 00:37:21,490
MANUFACTURERS OP VOLUNTARY AND

1136
00:37:21,490 --> 00:37:22,725
MUTUALLY AGREED TO TERMS, OR

1137
00:37:22,725 --> 00:37:24,927
COMMITTING TO LICENSE ALL THE IP

1138
00:37:24,927 --> 00:37:27,129
NEEDED TO MAKE A PRODUCT IF THE

1139
00:37:27,129 --> 00:37:29,532
LICENSEE LATER DECIDES TO EXIT

1140
00:37:29,532 --> 00:37:30,833
THE MARKET.

1141
00:37:30,833 --> 00:37:35,671
NEXT ON THIS LIST, PARTNERING

1142
00:37:35,671 --> 00:37:36,672
PARTNERSHIPS FOR COMMITMENT.

1143
00:37:36,672 --> 00:37:37,873
EXAMPLES HERE MIGHT INCLUDE

1144
00:37:37,873 --> 00:37:39,742
SOMETHING LIKE COMMITTING TO

1145
00:37:39,742 --> 00:37:41,911
SUPPLY PRODUCT IN A GIVEN MARKET

1146
00:37:41,911 --> 00:37:44,013
OR MARKETS FOR A DESIGNATED

1147
00:37:44,013 --> 00:37:45,548
DURATION, OR IT COULD INCLUDE

1148
00:37:45,548 --> 00:37:47,750
AGREEING TO COORDINATE AND SET

1149
00:37:47,750 --> 00:37:49,619
ASIDE A PORTION OF THE LICENSED

1150
00:37:49,619 --> 00:37:51,587
PRODUCT ONCE IT'S BEEN

1151
00:37:51,587 --> 00:37:53,322
MANUFACTURED, COORDINATION OR

1152
00:37:53,322 --> 00:37:54,457
SALE TO A PARTNER ORGANIZATION

1153
00:37:54,457 --> 00:37:58,761
ON A COST-PLUS BASIS.

1154
00:37:58,761 --> 00:38:00,596
NEXT, SUBMITTING ADDITIONAL

1155
00:38:00,596 --> 00:38:02,398
COMMERCIALIZATION PLANS TARGETED

1156
00:38:02,398 --> 00:38:05,234
TO OTHER MARKETS.

1157
00:38:05,234 --> 00:38:07,970
ONE EXAMPLE COULD INCLUDE A

1158
00:38:07,970 --> 00:38:09,271
FOLLOW-UP PRODUCT DEVELOPMENT

1159
00:38:09,271 --> 00:38:11,240
TIMELINE AND PLAN TO DEVELOP A

1160
00:38:11,240 --> 00:38:13,776
NEW FORMULATION OF A PRODUCT

1161
00:38:13,776 --> 00:38:15,645
THAT WOULD BE TAILORED TO

1162
00:38:15,645 --> 00:38:17,647
MEETING A POPULATION'S UNIQUE

1163
00:38:17,647 --> 00:38:18,147
NEED.

1164
00:38:18,147 --> 00:38:19,715
FOR EXAMPLE IF THE LICENSEE

1165
00:38:19,715 --> 00:38:20,449
INITIALLY BRINGS A FORMULATION

1166
00:38:20,449 --> 00:38:22,251
OF A PRODUCT TO MARKET AND THAT

1167
00:38:22,251 --> 00:38:24,120
DOESN'T MEET EVERY PATIENT'S

1168
00:38:24,120 --> 00:38:25,755
NEEDS, THEY COULD FOLLOW ON WITH

1169
00:38:25,755 --> 00:38:26,288
ADDITIONAL COMMERCIAL

1170
00:38:26,288 --> 00:38:27,523
DEVELOPMENT PLANS TO EXPAND THE

1171
00:38:27,523 --> 00:38:29,158
REACH TO FURTHER PATIENTS AND

1172
00:38:29,158 --> 00:38:33,262
COMMUNITIES.

1173
00:38:33,262 --> 00:38:35,331
THEN NEXT ON THE LIST, PROMOTING

1174
00:38:35,331 --> 00:38:37,066
EQUITABLE ACCESS AND

1175
00:38:37,066 --> 00:38:39,935
AFFORDABILITY IN PRODUCT

1176
00:38:39,935 --> 00:38:41,270
DEVELOPMENT AND DEPLOYMENT.

1177
00:38:41,270 --> 00:38:43,272
EXAMPLES MENTIONED HERE COULD

1178
00:38:43,272 --> 00:38:44,774
INCLUDE THINGS LIKE COMMITTING

1179
00:38:44,774 --> 00:38:46,108
TO KEEP PRICES IN THE UNITED

1180
00:38:46,108 --> 00:38:47,309
STATES EQUAL TO THOSE IN OTHER

1181
00:38:47,309 --> 00:38:48,978
DEVELOPED COUNTRIES, NOT RAISING

1182
00:38:48,978 --> 00:38:50,279
PRODUCT COSTS AND PRICES ABOVE

1183
00:38:50,279 --> 00:38:52,581
THE RATE OF INFLATION, OR

1184
00:38:52,581 --> 00:38:55,184
PREPARING TAILORED CULTURALLY

1185
00:38:55,184 --> 00:38:56,752
SENSITIVE EDUCATIONAL MATERIALS

1186
00:38:56,752 --> 00:38:59,822
FOR A RANGE OF PATIENT

1187
00:38:59,822 --> 00:39:02,625
POPULATIONS ACROSS THE COUNTRY

1188
00:39:02,625 --> 00:39:03,492
AND THE GLOBE.

1189
00:39:03,492 --> 00:39:05,327
I ALSO WANT TO NOTE THE LAST

1190
00:39:05,327 --> 00:39:05,795
BULLET POINT HERE.

1191
00:39:05,795 --> 00:39:07,697
WE WANT TO INVITE OUR LICENSEES

1192
00:39:07,697 --> 00:39:08,964
TO LET US KNOW IF THERE ARE

1193
00:39:08,964 --> 00:39:11,067
THINGS WE, NIH AND THE UNITED

1194
00:39:11,067 --> 00:39:11,634
STATES GOVERNMENT, COULD BE

1195
00:39:11,634 --> 00:39:13,169
DOING TO HELP THEM MEET THEIR

1196
00:39:13,169 --> 00:39:14,236
ACCESS GOALS.

1197
00:39:14,236 --> 00:39:16,639
THIS MIGHT INVOLVE, FOR EXAMPLE,

1198
00:39:16,639 --> 00:39:18,307
CONNECTING LICENSEES WITH

1199
00:39:18,307 --> 00:39:20,276
EXISTING NIH OR OTHER U.S.

1200
00:39:20,276 --> 00:39:22,511
GOVERNMENT PROGRAMS OR

1201
00:39:22,511 --> 00:39:24,580
RESOURCES, MERELY BY WAY OF

1202
00:39:24,580 --> 00:39:26,015
EXAMPLE, WE AT NIH HAVE PROGRAMS

1203
00:39:26,015 --> 00:39:27,650
TO SUPPORT PRE-CLINICAL

1204
00:39:27,650 --> 00:39:28,851
DEVELOPMENT WORK, AND PROGRAMS

1205
00:39:28,851 --> 00:39:30,853
THAT ALLOW US TO SHARE SOME

1206
00:39:30,853 --> 00:39:33,889
IN-HOUSE PRODUCT DEVELOPMENT

1207
00:39:33,889 --> 00:39:34,457
EXPERTISE.

1208
00:39:34,457 --> 00:39:35,991
SO AGAIN, AS PART OF THE ACCESS

1209
00:39:35,991 --> 00:39:38,861
PLANNING PROPOSAL BUT ALSO AS

1210
00:39:38,861 --> 00:39:40,162
PART OF THE RFI, WE'RE

1211
00:39:40,162 --> 00:39:42,164
INTERESTED IN HEARING REACTIONS,

1212
00:39:42,164 --> 00:39:44,767
REFLECTIONS FROM THE PUBLIC AND

1213
00:39:44,767 --> 00:39:45,768
FROM VARIOUS INTERESTED

1214
00:39:45,768 --> 00:39:46,635
COMMUNITIES ABOUT THINGS THAT WE

1215
00:39:46,635 --> 00:39:48,404
CAN BE DOING TO ADVANCE OUR

1216
00:39:48,404 --> 00:39:52,041
SHARED ACCESS GOALS.

1217
00:39:52,041 --> 00:39:54,376
I ALSO WANT TO NOTE IN THE RFI

1218
00:39:54,376 --> 00:39:55,778
WHEN WE DEFINE ACCESS, WE'VE

1219
00:39:55,778 --> 00:39:59,749
TRIED TO TAKE A BROAD LENS.

1220
00:39:59,749 --> 00:40:01,050
WE RECOGNIZE THERE ARE MYRIAD

1221
00:40:01,050 --> 00:40:02,618
FACTORS THAT AFFECT ACCESS TO

1222
00:40:02,618 --> 00:40:03,385
EMERGING BIOMEDICAL

1223
00:40:03,385 --> 00:40:04,887
TECHNOLOGIES.

1224
00:40:04,887 --> 00:40:08,557
THAT INCLUDE FACTORS SUCH AS

1225
00:40:08,557 --> 00:40:09,225
AFFORDABILITY, PATIENTS CANNOT

1226
00:40:09,225 --> 00:40:10,626
GET THE BENEFIT OF PRODUCTS THEY

1227
00:40:10,626 --> 00:40:14,263
CANNOT AFFORD.

1228
00:40:14,263 --> 00:40:16,132
AVAILABILITY, IF A PRODUCT DOES

1229
00:40:16,132 --> 00:40:17,833
NOT EXIST, IF A PRODUCT IS NOT

1230
00:40:17,833 --> 00:40:20,102
BEING MANUFACTURED OR SUPPLIED

1231
00:40:20,102 --> 00:40:22,938
IN A GIVEN REGION.

1232
00:40:22,938 --> 00:40:25,007
IT'IF THE REGULATORY AUTHORITIES

1233
00:40:25,007 --> 00:40:26,175
HAVE NOT APPROVED THE PRODUCT,

1234
00:40:26,175 --> 00:40:28,010
THEN THAT PRODUCT CANNOT DELIVER

1235
00:40:28,010 --> 00:40:32,281
VALUE TO PATIENTS.

1236
00:40:32,281 --> 00:40:33,082
ACCEPTABILITY, FOR EXAMPLE, WILL

1237
00:40:33,082 --> 00:40:34,517
THE PRODUCT RESONATE WITH END

1238
00:40:34,517 --> 00:40:35,785
USERS, WILL THEY BE WILLING AND

1239
00:40:35,785 --> 00:40:37,153
ABLE TO USE THE PRODUCT?

1240
00:40:37,153 --> 00:40:39,255
AND FINALLY, SUSTAINABILITY.

1241
00:40:39,255 --> 00:40:42,391
PART OF THAT IS A RECOGNITION

1242
00:40:42,391 --> 00:40:43,793
THAT WHAT IS ACCESSIBLE TODAY

1243
00:40:43,793 --> 00:40:47,163
MAY NOT BE ACCESSIBLE SEVERAL

1244
00:40:47,163 --> 00:40:49,565
YEARS FROM NOW BUT PATIENTS

1245
00:40:49,565 --> 00:40:51,834
MIGHT NEED OR WANT A PRODUCT

1246
00:40:51,834 --> 00:40:52,434
SEVERAL YEARS FROM NOW.

1247
00:40:52,434 --> 00:40:54,970
SO WITH THE RFI, WE'VE INVITED

1248
00:40:54,970 --> 00:40:56,705
LICENSEES TO WORK ALONG ANY OR

1249
00:40:56,705 --> 00:41:00,442
MULTIPLE OF THESE AK SEES TO

1250
00:41:00,442 --> 00:41:02,645
DELIVER -- WHEN WE RECOGNIZED IT

1251
00:41:02,645 --> 00:41:04,980
MIGHT NOT MAKE SENSE FOR AN

1252
00:41:04,980 --> 00:41:06,615
ADDRESSEE TO ADDRESS ALL OF

1253
00:41:06,615 --> 00:41:08,050
THESE, THE IDEA WITH THE DRAFT

1254
00:41:08,050 --> 00:41:09,151
PROPOSAL AT THIS POINT, AT

1255
00:41:09,151 --> 00:41:12,788
LEAST, WOULD BE TO HAVE

1256
00:41:12,788 --> 00:41:13,823
LICENSEES CONSIDER THOSE THAT

1257
00:41:13,823 --> 00:41:16,859
FIT THEIR PRODUCT AND MARKET AND

1258
00:41:16,859 --> 00:41:18,194
THAT FIT THEIR PATIENT

1259
00:41:18,194 --> 00:41:18,828
POPULATION BEST.

1260
00:41:18,828 --> 00:41:20,162
FINALLY THE DRAFT PROPOSED

1261
00:41:20,162 --> 00:41:21,230
POLICY WOULD ACCOUNT FOR THE

1262
00:41:21,230 --> 00:41:22,998
STAGE OF TECHNOLOGY DEVELOPMENT.

1263
00:41:22,998 --> 00:41:25,768
MOST OF NIH'S LICENSES ARE EARLY

1264
00:41:25,768 --> 00:41:27,603
STAGE AND FOR THOSE LICENSES,

1265
00:41:27,603 --> 00:41:32,107
THE STRUCTURE HERE IS THE ONE I

1266
00:41:32,107 --> 00:41:32,775
JUST DESCRIBED.

1267
00:41:32,775 --> 00:41:34,610
IN THE INSTANCES WHERE NIH

1268
00:41:34,610 --> 00:41:36,946
ADVANCES TECHNOLOGY PRETTY FAR

1269
00:41:36,946 --> 00:41:39,348
ALONG, AT THAT POINT, WE ALREADY

1270
00:41:39,348 --> 00:41:40,449
KNOW MORE ABOUT THE PRODUCT, WE

1271
00:41:40,449 --> 00:41:42,084
HAVE A BETTER SENSE OF WHO THE

1272
00:41:42,084 --> 00:41:43,419
PATIENTS WILL BE, AND WE WILL

1273
00:41:43,419 --> 00:41:45,254
HAVE A BETTER SENSE OF WHAT

1274
00:41:45,254 --> 00:41:47,056
MECHANISMS MIGHT BE AVAILABLE TO

1275
00:41:47,056 --> 00:41:50,459
IMPROVE PATIENT ACCESS.

1276
00:41:50,459 --> 00:41:52,528
IN THOSE CIRCUMSTANCES, WE'RE

1277
00:41:52,528 --> 00:41:54,830
EXPLORING ADDING DIFFERENT

1278
00:41:54,830 --> 00:41:58,133
SPECIFICS TO THOSE LICENSES,

1279
00:41:58,133 --> 00:41:59,201
TAILORED ACCESS ORIENTED

1280
00:41:59,201 --> 00:42:00,870
PROVISIONS FOR THESE LATE STAGE

1281
00:42:00,870 --> 00:42:02,071
LICENSES, AND THAT'S A DETAIL

1282
00:42:02,071 --> 00:42:04,039
WE'RE ALSO ACTIVELY EXPLORING

1283
00:42:04,039 --> 00:42:06,242
INCLUDING THROUGH THIS RFI.

1284
00:42:06,242 --> 00:42:07,877
SO THAT'S THE PROPOSAL.

1285
00:42:07,877 --> 00:42:09,778
AGAIN, WE'RE INVITING PUBLIC

1286
00:42:09,778 --> 00:42:11,413
INPUT ON EVERYTHING I JUST

1287
00:42:11,413 --> 00:42:11,647
SHARED.

1288
00:42:11,647 --> 00:42:14,917
IN ADDITION TO THOSE ASPECTS OF

1289
00:42:14,917 --> 00:42:17,887
A DRAFT PROPOSED POLICY, WE HAVE

1290
00:42:17,887 --> 00:42:22,491
A HANDFUL OF QUESTIONS THAT WE

1291
00:42:22,491 --> 00:42:24,994
ALSO INCLUDED IN THE RFI WHERE

1292
00:42:24,994 --> 00:42:26,695
WE'RE ALSO INTERESTED IN HEARING

1293
00:42:26,695 --> 00:42:29,298
IDEAS FROM THE COMMUNITY.

1294
00:42:29,298 --> 00:42:31,700
THE FIRST OF THOSE QUESTIONS IS

1295
00:42:31,700 --> 00:42:33,035
FOCUSED ON IDEAS ABOUT

1296
00:42:33,035 --> 00:42:35,404
STRATEGIES FOR IMPROVING ACCESS.

1297
00:42:35,404 --> 00:42:37,006
FOR EXAMPLE, IF YOU HAVE

1298
00:42:37,006 --> 00:42:38,240
EXPERIENCE WITH COMMERCIALLY

1299
00:42:38,240 --> 00:42:41,043
REASONABLE APPROACHES TO PROMOTE

1300
00:42:41,043 --> 00:42:43,646
PATIENT ACCESS IN THESE OR OTHER

1301
00:42:43,646 --> 00:42:44,513
CIRCUMSTANCES, WE WOULD LOVE TO

1302
00:42:44,513 --> 00:42:46,048
HEAR THAT FEEDBACK.

1303
00:42:46,048 --> 00:42:47,950
WE HAVE A QUESTION ABOUT

1304
00:42:47,950 --> 00:42:49,351
PROMOTING TRANSPARENCY IN THE

1305
00:42:49,351 --> 00:42:51,253
BIOMEDICAL RESEARCH ENTERPRISE

1306
00:42:51,253 --> 00:42:53,756
AND RETURN ON INVESTMENT.

1307
00:42:53,756 --> 00:42:55,491
THAT'S WITH AN EYE TOWARD,AGE

1308
00:42:55,491 --> 00:42:57,693
OTHER THINGS, DRIVING DOWN COSTS

1309
00:42:57,693 --> 00:43:00,229
ASSOCIATED WITH INNOVATION,

1310
00:43:00,229 --> 00:43:02,531
MAKING CLEAR WHAT COSTS ARE

1311
00:43:02,531 --> 00:43:04,400
INCURRED ALONG THE WAY, AND

1312
00:43:04,400 --> 00:43:06,502
MAKING CLEAR HOW THOSE COSTS

1313
00:43:06,502 --> 00:43:09,071
AFFECT PRODUCT COSTS.

1314
00:43:09,071 --> 00:43:11,573
UNDER THE THIRD QUESTION ABOUT

1315
00:43:11,573 --> 00:43:13,542
PROVIDING FLEXIBILITY WHILE

1316
00:43:13,542 --> 00:43:15,544
ACHIEVING CLEAR POLICY

1317
00:43:15,544 --> 00:43:16,445
OBJECTIVES, WE REALIZE THAT

1318
00:43:16,445 --> 00:43:18,847
INCLUDES EVERYONE, NIH, OUR

1319
00:43:18,847 --> 00:43:20,249
LICENSEES, OUR LICENSEES'

1320
00:43:20,249 --> 00:43:21,717
PARTNERS AND THE PUBLIC NEED

1321
00:43:21,717 --> 00:43:23,886
CONFIDENCE AROUND WHAT THIS

1322
00:43:23,886 --> 00:43:25,321
POLICY WOULD REQUIRE.

1323
00:43:25,321 --> 00:43:26,322
LIKEWISE, THERE'S A NEED FOR

1324
00:43:26,322 --> 00:43:27,423
CLARITY AND CERTAINTY AROUND THE

1325
00:43:27,423 --> 00:43:29,291
STANDARDS THAT WOULD BE USED TO

1326
00:43:29,291 --> 00:43:31,794
EVALUATE ACCESS PLANS FOR

1327
00:43:31,794 --> 00:43:33,462
WAIVERS, SO WE'RE SEEKING INPUT

1328
00:43:33,462 --> 00:43:35,564
ON THOSE ASPECTS OF THE POLICY

1329
00:43:35,564 --> 00:43:38,400
LOOKING TO ALLOW FLEXIBILITY FOR

1330
00:43:38,400 --> 00:43:40,002
LICENSEES TO PURSUE SPECIFIC

1331
00:43:40,002 --> 00:43:41,837
PRODUCT DEVELOPMENT NEEDS WHILE

1332
00:43:41,837 --> 00:43:42,871
SIMULTANEOUSLY PROMOTING

1333
00:43:42,871 --> 00:43:46,942
CERTAINTY AND TRANSPARENCY.

1334
00:43:46,942 --> 00:43:48,644
AS I MENTIONED, WE WANT TO HEAR

1335
00:43:48,644 --> 00:43:51,280
IDEAS ABOUT HOW NIH CAN HELP

1336
00:43:51,280 --> 00:43:52,581
LICENSEES DELIVER PATIENT ACCESS

1337
00:43:52,581 --> 00:43:55,017
TO PRODUCT THAT STEM FROM THESE

1338
00:43:55,017 --> 00:43:56,785
IRP PATENT LICENSING AGREEMENTS.

1339
00:43:56,785 --> 00:43:59,521
WE HAVE A QUESTION ABOUT

1340
00:43:59,521 --> 00:44:00,622
ESTABLISHING LICENSEE

1341
00:44:00,622 --> 00:44:01,523
OBLIGATIONS DEPENDING ON THE

1342
00:44:01,523 --> 00:44:02,825
STAGE OF A TECHNOLOGY'S

1343
00:44:02,825 --> 00:44:05,227
DEVELOPMENT.

1344
00:44:05,227 --> 00:44:06,428
AND THE FINAL QUESTION IN THE

1345
00:44:06,428 --> 00:44:08,430
RFI IS FOCUSED ON ASSESSING

1346
00:44:08,430 --> 00:44:09,999
POLICY IMPACT.

1347
00:44:09,999 --> 00:44:12,167
WHAT METRICS COULD THE AGENCY

1348
00:44:12,167 --> 00:44:16,538
USE IN THE NEAR TERM AND THE

1349
00:44:16,538 --> 00:44:19,008
LONG TERM AND ACCESS PLANNING

1350
00:44:19,008 --> 00:44:19,608
POLICY.

1351
00:44:19,608 --> 00:44:21,577
SO BEFORE WE TURN TO A FEW

1352
00:44:21,577 --> 00:44:22,678
QUESTIONS, I JUST WANTED TO

1353
00:44:22,678 --> 00:44:25,114
OFFER A FEW KEY LINKS.

1354
00:44:25,114 --> 00:44:26,882
AS A REMINDER, THE REQUEST FOR

1355
00:44:26,882 --> 00:44:28,183
INFORMATION THAT WE'RE TALKING

1356
00:44:28,183 --> 00:44:30,953
ABOUT TODAY IS OPEN UNTIL

1357
00:44:30,953 --> 00:44:32,388
JULY 22ND, AND WE INVITE ANYONE

1358
00:44:32,388 --> 00:44:33,922
WHO IS INTERESTED TO SHARE THEIR

1359
00:44:33,922 --> 00:44:36,125
FEEDBACK ON OR BEFORE THAT DATE.

1360
00:44:36,125 --> 00:44:38,227
HERE'S A LINK TO THE FEDERAL

1361
00:44:38,227 --> 00:44:39,094
REGISTER PAGE WHERE YOU CAN FIND

1362
00:44:39,094 --> 00:44:40,529
ALL THE DETAILS WE JUST

1363
00:44:40,529 --> 00:44:41,930
PRESENTED.

1364
00:44:41,930 --> 00:44:43,832
AND THERE'S A COMMENT FORM ON

1365
00:44:43,832 --> 00:44:45,901
THE NIH OFFICE OF SCIENCE POLICY

1366
00:44:45,901 --> 00:44:50,739
WEBSITE WHERE YOU CAN SUBMIT

1367
00:44:50,739 --> 00:44:51,707
YOUR FEEDBACK, AND THEY ALSO MAY

1368
00:44:51,707 --> 00:44:54,043
BE INTERESTED IN THIS LINK TO

1369
00:44:54,043 --> 00:44:55,711
THE NIH TECHNOLOGY TRANSFER

1370
00:44:55,711 --> 00:44:59,681
COMMUNITY WE CAN S WEBSITE AND H

1371
00:44:59,681 --> 00:45:00,449
SCIENCE POLICY WEBSITE.

1372
00:45:00,449 --> 00:45:06,155
SO WITH THAT, WE ARE GOING TO --

1373
00:45:06,155 --> 00:45:07,456
I'LL ASK TARA TO JOIN ME AND

1374
00:45:07,456 --> 00:45:08,457
WE'LL TALK ABOUT SOME OF THE

1375
00:45:08,457 --> 00:45:12,294
QUESTIONS THAT WERE SUBMITTED IN

1376
00:45:12,294 --> 00:45:14,363
ADVANCE.

1377
00:45:14,363 --> 00:45:15,731
SO THE FIRST ONE I'LL START

1378
00:45:15,731 --> 00:45:17,566
WITH, WHO SHOULD RESPOND TO THE

1379
00:45:17,566 --> 00:45:18,000
RFI?

1380
00:45:18,000 --> 00:45:20,102
I'VE GOT SOME THOUGHTS ON THAT,

1381
00:45:20,102 --> 00:45:21,637
CERTAINLY I INVITE TARA TO CHIME

1382
00:45:21,637 --> 00:45:24,506
IN, BUT OVERALL, OUR AIM IN

1383
00:45:24,506 --> 00:45:26,708
RELEASING THIS RFI IS TO BE ABLE

1384
00:45:26,708 --> 00:45:30,813
TO SOLICIT REALLY ROBUST, BROAD

1385
00:45:30,813 --> 00:45:32,114
AND ENCOMPASSING STAKEHOLDER

1386
00:45:32,114 --> 00:45:33,916
FEEDBACK ON THIS DRAFT PROPOSED

1387
00:45:33,916 --> 00:45:35,217
POLICY, SO WE'RE WELCOMING

1388
00:45:35,217 --> 00:45:37,419
FEEDBACK FROM ALL TYPES OF

1389
00:45:37,419 --> 00:45:38,387
RESPONDENTS THAT WOULD INCLUDE

1390
00:45:38,387 --> 00:45:40,889
PATIENTS AND PATIENT ADVOCATES,

1391
00:45:40,889 --> 00:45:43,192
SMALL BUSINESSES AND STARTUPS,

1392
00:45:43,192 --> 00:45:44,259
TECHNOLOGY TRANSFER AND

1393
00:45:44,259 --> 00:45:45,327
LICENSING PROFESSIONALS,

1394
00:45:45,327 --> 00:45:48,697
INCLUDING FOLKS WITH EXPERIENCE

1395
00:45:48,697 --> 00:45:50,032
NEGOTIATING THESE TYPES OF

1396
00:45:50,032 --> 00:45:51,900
AGREEMENTS FOR EARLY STAGE

1397
00:45:51,900 --> 00:45:53,335
BIOMEDICAL PATENTS AND

1398
00:45:53,335 --> 00:45:54,636
NEGOTIATING THESE TYPES OF

1399
00:45:54,636 --> 00:45:56,171
TERMS, ACCESS PLANS OR OTHER

1400
00:45:56,171 --> 00:45:57,806
SIMILAR PROVISIONS.

1401
00:45:57,806 --> 00:46:02,344
WE WOULD WELCOME INPUT FROM

1402
00:46:02,344 --> 00:46:05,147
INVESTORS, INDUSTRY PARTNERS,

1403
00:46:05,147 --> 00:46:06,215
HEALTHCARE PROVIDERS,

1404
00:46:06,215 --> 00:46:07,349
UNIVERSITIES, OTHER PUBLIC

1405
00:46:07,349 --> 00:46:07,883
INTEREST GROUPS.

1406
00:46:07,883 --> 00:46:11,386
THE LIST GOES ON.

1407
00:46:11,386 --> 00:46:12,688
TARA, ARE THERE ANY CATEGORIES

1408
00:46:12,688 --> 00:46:14,590
YOU THINK I'VE MISSED?

1409
00:46:14,590 --> 00:46:16,692
>> I DON'T KNOW OF ANY,
BUT

1410
00:46:16,692 --> 00:46:18,060
PLEASE, IF YOU ARE NOT MENTIONED

1411
00:46:18,060 --> 00:46:19,595
AND YOU HAVE INPUT, PLEASE

1412
00:46:19,595 --> 00:46:20,796
PROVIDE IT, BECAUSE WE WANT TO

1413
00:46:20,796 --> 00:46:21,663
HEAR FROM EVERYONE.

1414
00:46:21,663 --> 00:46:24,633
WE DON'T WANT TO OPERATE IN A

1415
00:46:24,633 --> 00:46:26,735
VACUUM.

1416
00:46:26,735 --> 00:46:28,203
OUR STAKEHOLDER INPUT WHICH

1417
00:46:28,203 --> 00:46:29,071
INCLUDES ALL THESE GROUPS AND

1418
00:46:29,071 --> 00:46:30,939
MORE IS CRITICAL TO US FORMING A

1419
00:46:30,939 --> 00:46:33,008
GOOD AND USEFUL POLICY THAT WE

1420
00:46:33,008 --> 00:46:35,310
THINK WILL BENEFIT NOT JUST NIH

1421
00:46:35,310 --> 00:46:38,714
BUT THE PUBLIC WHEN OUR PRODUCTS

1422
00:46:38,714 --> 00:46:41,583
COME TO MARKET.

1423
00:46:41,583 --> 00:46:43,252
>> YEAH, MAYBE IT GOES
WITHOUT

1424
00:46:43,252 --> 00:46:44,453
SAYING, BUT THE RESPONSES THAT

1425
00:46:44,453 --> 00:46:45,854
WE RECEIVED FOR THE RFI ARE

1426
00:46:45,854 --> 00:46:47,556
GOING TO REALLY INFORM THE

1427
00:46:47,556 --> 00:46:50,058
AGENCY'S DEVELOPMENT OF NIL

1428
00:46:50,058 --> 00:46:52,794
FINAL POLICY, AND SO AS WE SAID

1429
00:46:52,794 --> 00:46:54,563
AT THE OUTSET, WE TAKE THIS PART

1430
00:46:54,563 --> 00:46:56,198
OF OUR JOB VERY SERIOUSLY AND

1431
00:46:56,198 --> 00:46:57,099
LOOK FORWARD TO HEARING FROM

1432
00:46:57,099 --> 00:46:58,400
YOU.

1433
00:46:58,400 --> 00:46:59,401
OKAY.

1434
00:46:59,401 --> 00:47:02,571
SO THE NEXT QUESTION I HAVE, AND

1435
00:47:02,571 --> 00:47:05,107
IT'S A LITTLE BIT OF A TWO

1436
00:47:05,107 --> 00:47:09,545
PARTER, WILL NIH ACCEPT ACCESS

1437
00:47:09,545 --> 00:47:13,048
PLAN THAT DON'T SUPPORT GLOBAL

1438
00:47:13,048 --> 00:47:13,382
ACCESS?

1439
00:47:13,382 --> 00:47:14,917
WE NOTE THE POLICY WOULD REQUIRE

1440
00:47:14,917 --> 00:47:16,818
PLANS SUPPORTING ACCESS FOR

1441
00:47:16,818 --> 00:47:19,888
UNDERSERVED U.S. AND/OR LMIC

1442
00:47:19,888 --> 00:47:20,856
POPULATION.

1443
00:47:20,856 --> 00:47:23,058
FOR THE CASES IN WHICH GLOBAL

1444
00:47:23,058 --> 00:47:25,394
ACCESS COMMITMENTS ARE

1445
00:47:25,394 --> 00:47:27,162
APPROPRIATE, WHERE THE LICENSEE

1446
00:47:27,162 --> 00:47:28,797
DOES NOT INCLUDE THEM IN THE

1447
00:47:28,797 --> 00:47:30,766
EQUITABLE ACCESS PLAN, HOW DOES

1448
00:47:30,766 --> 00:47:34,102
NIH INTEND TO ADVANCE GLOBAL

1449
00:47:34,102 --> 00:47:38,574
ACCESS PROVISION?

1450
00:47:38,574 --> 00:47:40,209
I WILL AT THE START RESPOND BY

1451
00:47:40,209 --> 00:47:42,444
REITERATING THAT THIS IS AN RFI.

1452
00:47:42,444 --> 00:47:43,946
OUR EARS ARE OPEN SO WE'RE

1453
00:47:43,946 --> 00:47:45,180
DEFINITELY INTERESTED IN HEARING

1454
00:47:45,180 --> 00:47:49,051
THOUGHTS FROM THE PUBLIC ON THAT

1455
00:47:49,051 --> 00:47:50,452
POINT.

1456
00:47:50,452 --> 00:47:52,120
ALSO JUST TO DOUBLE DOWN ON

1457
00:47:52,120 --> 00:47:53,322
SOMETHING WE'VE ALREADY

1458
00:47:53,322 --> 00:47:54,089
MENTIONED, WE'RE INTERESTED IN

1459
00:47:54,089 --> 00:47:56,758
SUGGESTIONS AND IDEAS FROM THE

1460
00:47:56,758 --> 00:47:57,626
PUBLIC ON COMMERCIALLY

1461
00:47:57,626 --> 00:47:59,928
REASONABLE STRATEGIES TO ADVANCE

1462
00:47:59,928 --> 00:48:02,464
BOTH DOMESTIC PUBLIC HEALTH AND

1463
00:48:02,464 --> 00:48:03,899
GLOBAL ACCESS GOALS.

1464
00:48:03,899 --> 00:48:06,001
ANOTHER PIECE OF THIS, AND I'LL

1465
00:48:06,001 --> 00:48:12,474
INVITE TARA TO CHIME IN,IS THAT

1466
00:48:12,474 --> 00:48:15,577
WE RECOGNIZE NO TWO NIH LICENSES

1467
00:48:15,577 --> 00:48:17,212
ARE THE SAME, THERE'S A LOT AT

1468
00:48:17,212 --> 00:48:18,146
PLAY WHEN IT COMES TO THE

1469
00:48:18,146 --> 00:48:19,014
COMMERCIALIZATION OF ANY

1470
00:48:19,014 --> 00:48:20,515
TECHNOLOGY.

1471
00:48:20,515 --> 00:48:22,284
THE SITUATION IS A VERY CASE TO

1472
00:48:22,284 --> 00:48:23,819
CASE, PATIENT TO PATIENT,

1473
00:48:23,819 --> 00:48:25,854
PRODUCT TO PRODUCT, LICENSEE TO

1474
00:48:25,854 --> 00:48:27,155
LICENSEE, SO WE DO WANT TO MAKE

1475
00:48:27,155 --> 00:48:28,323
SURE THAT WE'RE CHARTING A

1476
00:48:28,323 --> 00:48:29,291
POLICY THAT IS FLEXIBLE ENOUGH

1477
00:48:29,291 --> 00:48:30,826
TO REALLY ACCOMMODATE THAT RANGE

1478
00:48:30,826 --> 00:48:32,894
AND GIVES THE AGENCY FLEXIBILITY

1479
00:48:32,894 --> 00:48:35,564
TO WORK WITH OUR LICENSEES TO

1480
00:48:35,564 --> 00:48:37,332
MAKE SURE WE'RE DOING OUR LEVEL

1481
00:48:37,332 --> 00:48:41,937
BEST TO IMPROVE ACCESS.

1482
00:48:41,937 --> 00:48:43,138
I'LL STOP RAMBLING AND SEE IF

1483
00:48:43,138 --> 00:48:43,939
YOU HAVE SOME THOUGHTS.

1484
00:48:43,939 --> 00:48:45,807
I THINK I HAVE A COUPLE OTHERS,

1485
00:48:45,807 --> 00:48:46,041
THOUGH.

1486
00:48:46,041 --> 00:48:46,475
>> SURE.

1487
00:48:46,475 --> 00:48:48,043
I MEAN, I THINK THIS IS EXACTLY

1488
00:48:48,043 --> 00:48:50,579
UP WITH OF THE REASONS WHY WE

1489
00:48:50,579 --> 00:48:52,447
ARE COMING OUT WITH THIS RFI

1490
00:48:52,447 --> 00:48:53,515
BECAUSE WE ARE LOOKING FOR

1491
00:48:53,515 --> 00:48:54,316
IDEAS.

1492
00:48:54,316 --> 00:48:56,718
HOW COULD WE ADVANCE GLOBAL

1493
00:48:56,718 --> 00:49:00,589
ACCESS IF OUR LICENSEE IS NOT

1494
00:49:00,589 --> 00:49:01,957
ABLE TO AND IT SEEMS LIKE IT

1495
00:49:01,957 --> 00:49:04,793
WOULD BE APPROPRIATE IN THAT

1496
00:49:04,793 --> 00:49:05,060
CASE.

1497
00:49:05,060 --> 00:49:06,595
SO YES, DEFINITELY INPUT WOULD

1498
00:49:06,595 --> 00:49:10,632
BE VERY IMPORTANT, BUT AGAIN I

1499
00:49:10,632 --> 00:49:12,668
THINK WE STRESSED ALL ALONG THAT

1500
00:49:12,668 --> 00:49:14,736
WE WORK WITH OUR LICENSEES TO

1501
00:49:14,736 --> 00:49:17,339
FIND SOLUTIONS, WE DON'T WANT TO

1502
00:49:17,339 --> 00:49:19,474
PUNISH A COMPANY FOR NOT

1503
00:49:19,474 --> 00:49:20,475
PURSUING A SPECIFIC AVENUE, SO

1504
00:49:20,475 --> 00:49:22,010
MAYBE WE CAN FIND OTHER WAYS TO

1505
00:49:22,010 --> 00:49:23,145
ACHIEVE THAT GOAL, AND IT COULD

1506
00:49:23,145 --> 00:49:25,547
BE TAILORING THE LICENSE,

1507
00:49:25,547 --> 00:49:26,682
ENCOURAGING PARTNERSHIPS WITH

1508
00:49:26,682 --> 00:49:27,316
OTHER ORGANIZATIONS.

1509
00:49:27,316 --> 00:49:28,950
THERE ARE A LOT OF DIFFERENT

1510
00:49:28,950 --> 00:49:29,785
POSSIBILITIES AND WE WANT TO

1511
00:49:29,785 --> 00:49:31,420
HEAR FROM YOU ABOUT THINGS THAT

1512
00:49:31,420 --> 00:49:32,621
WE MAY NOT HAVE THOUGHT ABOUT.

1513
00:49:32,621 --> 00:49:36,425
WE CERTAINLY HAVE A LOT OF

1514
00:49:36,425 --> 00:49:37,492
EXPERIENCE WITH GENERAL

1515
00:49:37,492 --> 00:49:38,226
BIOMEDICAL PRODUCT DEVELOPMENT

1516
00:49:38,226 --> 00:49:41,129
WITH OUR LICENSES, BUT WE ARE

1517
00:49:41,129 --> 00:49:41,930
NOW FOCUSING MORE SPECIFICALLY

1518
00:49:41,930 --> 00:49:43,699
ON ACCESS, AND THAT'S WHERE WE

1519
00:49:43,699 --> 00:49:52,674
CAN USE YOUR INSIGHTS.

1520
00:49:52,674 --> 00:49:55,043
>> AND RECOGNIZING THAT NO
TWO

1521
00:49:55,043 --> 00:49:56,578
LICENSES ARE THE SAME, THE

1522
00:49:56,578 --> 00:49:57,746
ACCESS STRATEGIES THAT WERE

1523
00:49:57,746 --> 00:49:59,881
GOING TO NEED TO PURSUE AT ANY

1524
00:49:59,881 --> 00:50:02,951
GIVEN TIME ARE GOING TO VARY

1525
00:50:02,951 --> 00:50:04,619
FROM PRODUCT TO PRODUCT, LICENSE

1526
00:50:04,619 --> 00:50:05,487
TO LICENSE.

1527
00:50:05,487 --> 00:50:07,823
AT SOME POINT PATIENT TO PATIENT

1528
00:50:07,823 --> 00:50:11,727
OR PAISH COMMUNI PATIENT COMMUNT

1529
00:50:11,727 --> 00:50:12,594
COMMUNITY SO WE'RE GOING TO NEED

1530
00:50:12,594 --> 00:50:14,429
A LOT OF IDEAS ON THE TABLE AND

1531
00:50:14,429 --> 00:50:18,133
THE FLEXIBILITY TO WORK TOWARDS

1532
00:50:18,133 --> 00:50:20,001
THE BEST WE CAN GET IN

1533
00:50:20,001 --> 00:50:21,470
PARTNERSHIP WITH OUR LICENSEES

1534
00:50:21,470 --> 00:50:23,004
ON ACCESS PLANS THAT REALLY ARE

1535
00:50:23,004 --> 00:50:25,006
TAILORED TO THE PRODUCT, THE

1536
00:50:25,006 --> 00:50:29,745
LICENSEE AND THE PATIENT NEEDS,

1537
00:50:29,745 --> 00:50:31,246
AND I WOULD NOTE IN TERMS OF

1538
00:50:31,246 --> 00:50:32,447
THINKING ABOUT VARIATION FROM

1539
00:50:32,447 --> 00:50:33,682
ONE LICENSE TO ANOTHER, IN SOME

1540
00:50:33,682 --> 00:50:36,251
CASES OUR LICENSEES WILL NOT BE

1541
00:50:36,251 --> 00:50:37,686
AUTHORIZED TO DEVELOP OR SELL A

1542
00:50:37,686 --> 00:50:38,587
PRODUCT OUTSIDE THE UNITED

1543
00:50:38,587 --> 00:50:40,222
STATES, AND IN OTHER CASES, THE

1544
00:50:40,222 --> 00:50:43,291
LICENSEE WILL ONLY BE AUTHORIZED

1545
00:50:43,291 --> 00:50:46,628
TO MAKE A PRODUCT OUTSIDE OF THE

1546
00:50:46,628 --> 00:50:49,498
UNITED STATES, SO WE REALLY DO

1547
00:50:49,498 --> 00:50:51,800
WANT GOOD IDEAS, GUIDANCE,

1548
00:50:51,800 --> 00:50:52,968
CLARITY AND CERTAINTY, BUT ALSO

1549
00:50:52,968 --> 00:50:54,503
RETAIN THE FLEXIBILITY TO WORK

1550
00:50:54,503 --> 00:50:57,472
ON IMPROVING ACCESSORILY ACROSS

1551
00:50:57,472 --> 00:51:01,009
THAT RANGE IN WAYS THAT ARE A

1552
00:51:01,009 --> 00:51:05,247
WIN, WIN, WIN OUT COME FOR EVE 

1553
00:51:05,247 --> 00:51:05,547
EVERYONE.

1554
00:51:05,547 --> 00:51:06,748
I ALSO WANT TO NOTE, WE'RE NOT

1555
00:51:06,748 --> 00:51:08,016
GOING TO STOP DOING WHAT WE

1556
00:51:08,016 --> 00:51:09,684
ALREADY DO TO SUPPORT GLOBAL

1557
00:51:09,684 --> 00:51:12,954
HEALTH AND TO SUPPORT GLOBAL

1558
00:51:12,954 --> 00:51:13,989
ACCESS AS I REFERRED TO SOME OF

1559
00:51:13,989 --> 00:51:15,290
THESE STRATEGIES EARLIER, AND I

1560
00:51:15,290 --> 00:51:16,425
THINK ONE OF THE EXCITING THINGS

1561
00:51:16,425 --> 00:51:18,894
THAT THIS ACCESS PLANNING PO

1562
00:51:18,894 --> 00:51:21,797
WILL SEE INVITES US TO DO IS TO

1563
00:51:21,797 --> 00:51:22,764
LEVERAGE SOME OF THE STRATEGIES

1564
00:51:22,764 --> 00:51:23,565
THAT ARE REAL TRIED AND TRUE

1565
00:51:23,565 --> 00:51:26,134
THAT THE AGENCY HAS A LOT OF

1566
00:51:26,134 --> 00:51:29,070
EXPERIENCE WITH SUCCESSFULLY

1567
00:51:29,070 --> 00:51:30,839
DELIVERING ACCESS SOMETIMES IN A

1568
00:51:30,839 --> 00:51:33,742
GLOBAL -- PRIMARILY IN A GLOBAL

1569
00:51:33,742 --> 00:51:35,277
DIRECTION, LEVERAGING THOSE SAME

1570
00:51:35,277 --> 00:51:36,945
THINGS AND THINKING ABOUT HOW WE

1571
00:51:36,945 --> 00:51:38,580
IMPROVE PATIENT ACCESS TO NEW

1572
00:51:38,580 --> 00:51:39,948
TREATMENTS WITHIN THE U.S. USING

1573
00:51:39,948 --> 00:51:41,716
SOME OF THE SAME PARTNERSHIPS,

1574
00:51:41,716 --> 00:51:42,918
SOME OF THE SAME STRATEGIES THAT

1575
00:51:42,918 --> 00:51:48,223
WE'VE HAD SUCCESS WITH BEFORE.

1576
00:51:48,223 --> 00:51:50,258
>> I'LL ADD ON TO THAT, WE
HAVE

1577
00:51:50,258 --> 00:51:52,194
MANY TECHNOLOGIES THAT ARE HARD

1578
00:51:52,194 --> 00:51:53,895
TO LICENSE NOT JUST BECAUSE

1579
00:51:53,895 --> 00:51:56,097
THEY'RE EARLY STAGE, BUT PERHAPS

1580
00:51:56,097 --> 00:51:59,601
THEY'RE FOR A RARE DISEASE OR A

1581
00:51:59,601 --> 00:52:02,871
NNEGLECTED TROPICAL DISEASE, SO

1582
00:52:02,871 --> 00:52:04,840
IN THOSE CASES WE REALLY DEPEND

1583
00:52:04,840 --> 00:52:06,475
ON PARTNERSHIPS, NOT THAT WE

1584
00:52:06,475 --> 00:52:07,943
JUST LICENSE TO A PARTNER, WE

1585
00:52:07,943 --> 00:52:09,244
FIND OTHER STAKEHOLDERS TO

1586
00:52:09,244 --> 00:52:10,679
COLLABORATE WITH US TO HELP GET

1587
00:52:10,679 --> 00:52:12,347
THAT PRODUCT DEVELOPED AND TO

1588
00:52:12,347 --> 00:52:13,482
THE PATIENT, SO THERE'S NO ONE

1589
00:52:13,482 --> 00:52:14,916
SIZE FITS ALL, AND WE EXPECT

1590
00:52:14,916 --> 00:52:18,186
THAT'S GOING TO BE THE CASE

1591
00:52:18,186 --> 00:52:18,386
HERE.

1592
00:52:18,386 --> 00:52:19,888
IN THE END, WE JUST WANT TO FIND

1593
00:52:19,888 --> 00:52:20,856
SOMETHING THAT'S REASONABLE AND

1594
00:52:20,856 --> 00:52:25,494
TO THE EXTENT THAT WE CAN HELP

1595
00:52:25,494 --> 00:52:26,728
OUR LICENSEES FIND OTHER WAYS TO

1596
00:52:26,728 --> 00:52:27,729
EXPAND ACCESS OR WAYS THAT WE

1597
00:52:27,729 --> 00:52:30,232
CAN SUPPORT THEM IN THAT GOAL,

1598
00:52:30,232 --> 00:52:31,700
WE WOULD LOVE TO BE ABLE TO

1599
00:52:31,700 --> 00:52:33,335
EXPLORE THOSE FURTHER AND ACT ON

1600
00:52:33,335 --> 00:52:38,740
THOSE IF WE CAN.

1601
00:52:38,740 --> 00:52:39,608
>> OKAY.

1602
00:52:39,608 --> 00:52:40,842
THEN THE LAST QUESTION THAT WE

1603
00:52:40,842 --> 00:52:45,313
RECEIVED, I WILL READ THIS ONE,

1604
00:52:45,313 --> 00:52:49,718
HOW WELL DOES THIS ACCESS WORK

1605
00:52:49,718 --> 00:52:51,386
FOR INVESTIGATORS WHO LEAVE NIH

1606
00:52:51,386 --> 00:52:54,823
AND START A COMPANY?

1607
00:52:54,823 --> 00:52:56,458
SO I THINK BEFORE WE DIVE IN ON

1608
00:52:56,458 --> 00:52:58,860
ANSWERING THAT QUESTION, IT'S

1609
00:52:58,860 --> 00:53:00,495
PERHAPS WORTH REFLECTING ON SOME

1610
00:53:00,495 --> 00:53:03,565
OF THE UNIQUE LEGAL AND ETHICAL

1611
00:53:03,565 --> 00:53:04,966
RULES AND POLICIES AND

1612
00:53:04,966 --> 00:53:05,967
PROCEDURES THAT ARE IN PLACE TO

1613
00:53:05,967 --> 00:53:07,235
AVOID CONFLICTS OF INTEREST FOR

1614
00:53:07,235 --> 00:53:08,537
OUR INTRAMURAL PROGRAM

1615
00:53:08,537 --> 00:53:11,706
INVESTIGATORS.

1616
00:53:11,706 --> 00:53:13,575
AND BECAUSE THERE ARE A LOT OF

1617
00:53:13,575 --> 00:53:14,609
THINGS IN PLACE THAT GOVERN THE

1618
00:53:14,609 --> 00:53:17,012
WORK OF THE SCIENTISTS HERE ON

1619
00:53:17,012 --> 00:53:17,245
CAMPUS.

1620
00:53:17,245 --> 00:53:19,014
FOR EXAMPLE, AN NIH INVESTIGATOR

1621
00:53:19,014 --> 00:53:20,115
CANNOT START THEIR OWN NEW

1622
00:53:20,115 --> 00:53:21,416
COMPANY WHILE THEY'RE CURRENTLY

1623
00:53:21,416 --> 00:53:25,687
WORKING AT NIH.

1624
00:53:25,687 --> 00:53:27,122
AND ALSO EVEN AFTER AN NIH

1625
00:53:27,122 --> 00:53:28,590
EMPLOYEE LEAVES THE AGENCY,

1626
00:53:28,590 --> 00:53:29,491
THERE ARE STILL CONSIDERATIONS

1627
00:53:29,491 --> 00:53:33,628
AND MAYBE SOME LIMITATIONS ON

1628
00:53:33,628 --> 00:53:35,263
WHAT OPTIONS ARE AVAILABLE TO

1629
00:53:35,263 --> 00:53:36,631
THEM, SO AN INVESTIGATOR MIGHT

1630
00:53:36,631 --> 00:53:38,166
NOT BE ABLE TO JOIN A COMPANY

1631
00:53:38,166 --> 00:53:39,734
FOR A FEW YEARS IF THAT COMPANY

1632
00:53:39,734 --> 00:53:42,604
IS WORKING ON TECHNOLOGY RELATED

1633
00:53:42,604 --> 00:53:43,605
TO WHAT THE INVESTIGATOR WAS

1634
00:53:43,605 --> 00:53:46,341
DOING WHILE THEY WERE AT THE

1635
00:53:46,341 --> 00:53:48,009
AGENCY.

1636
00:53:48,009 --> 00:53:49,210
THERE MIGHT BE RESTRICTIONS ON

1637
00:53:49,210 --> 00:53:50,812
THE INVESTIGATOR'S ABILITY TO

1638
00:53:50,812 --> 00:53:52,213
NEGOTIATE A PATENT LICENSE

1639
00:53:52,213 --> 00:53:56,084
DIRECTLY WITH NIH AFTER THEY

1640
00:53:56,084 --> 00:53:57,218
LEAVE, SO THERE ARE SOME SPECIAL

1641
00:53:57,218 --> 00:53:58,453
CONSIDERATIONS CERTAINLY IN

1642
00:53:58,453 --> 00:54:06,728
PLACE IN THE CIRCUMSTANCE.

1643
00:54:06,728 --> 00:54:07,829
ANYTHING ELSE YOU WOULD ADD ON

1644
00:54:07,829 --> 00:54:08,029
THAT?

1645
00:54:08,029 --> 00:54:09,931
>> NO, JUST TO EMPHASIZE
THAT,

1646
00:54:09,931 --> 00:54:11,032
YOU KNOW, WE CERTAIN WILL I HAVE

1647
00:54:11,032 --> 00:54:12,734
A NUMBER OF FORMER INVESTIGATORS

1648
00:54:12,734 --> 00:54:14,736
AT NIH WHO HAVE GONE OUT TO

1649
00:54:14,736 --> 00:54:15,837
START COMPANIES EITHER RELATING

1650
00:54:15,837 --> 00:54:18,440
TO THEIR TECHNOLOGIES OR

1651
00:54:18,440 --> 00:54:22,277
SOMETHING DIFFERENT, AND WE

1652
00:54:22,277 --> 00:54:23,378
TREAT EVERYBODY THE SAME.

1653
00:54:23,378 --> 00:54:25,847
WE DON'T HAVE PREFERENTIAL

1654
00:54:25,847 --> 00:54:27,582
TREATMENT BECAUSE SOMEBODY

1655
00:54:27,582 --> 00:54:29,150
WORKED AT NIH.

1656
00:54:29,150 --> 00:54:30,752
WE DO THE BEST JOB WE CAN FOR

1657
00:54:30,752 --> 00:54:31,720
THEM, AND THAT'S OUR PRIMARY

1658
00:54:31,720 --> 00:54:35,890
GOAL.

1659
00:54:35,890 --> 00:54:39,127
>> SO I THINK THAT KIND OF
GOES

1660
00:54:39,127 --> 00:54:43,031
TO THE QUESTION, HOW WOULD THE

1661
00:54:43,031 --> 00:54:44,532
ACCESS PLANNING POLICY APPLY

1662
00:54:44,532 --> 00:54:47,936
AFTER AN INVESTIGATOR, HE OR SHE

1663
00:54:47,936 --> 00:54:51,773
LEFT THE AGENCY AND JOINED THE

1664
00:54:51,773 --> 00:54:52,741
COMPANY DOWN THE ROAD

1665
00:54:52,741 --> 00:54:54,142
INTERESTING IN LICENSING NIH

1666
00:54:54,142 --> 00:54:55,110
TECHNOLOGY, THAT COMPANY WOULD

1667
00:54:55,110 --> 00:54:56,911
BE TREATED LIKE ALL OTHER

1668
00:54:56,911 --> 00:54:58,113
LICENSEES WHEN IT COMES TO THE

1669
00:54:58,113 --> 00:55:02,617
ACCESS PLANNING POLICY.

1670
00:55:02,617 --> 00:55:06,588
SO, YEAH.

1671
00:55:06,588 --> 00:55:08,356
>> THANKS FOR ALL THOSE
GREAT

1672
00:55:08,356 --> 00:55:08,623
QUESTIONS.

1673
00:55:08,623 --> 00:55:09,991
>> THANKS AGAIN TO
EVERYBODY FOR

1674
00:55:09,991 --> 00:55:12,427
JOINING AND FOR YOUR ENGAGEMENT

1675
00:55:12,427 --> 00:55:13,762
WITH THIS ISSUE AND WE LOOK

1676
00:55:13,762 --> 00:55:14,863
FORWARD TO CONTINUING TO HEAR

1677
00:55:14,863 --> 00:55:18,166
WHAT FOLKS HAVE TO SAY OVER THE

1678
00:55:18,166 --> 00:55:19,834
COMING MONTH AND CHANGE.

1679
00:55:19,834 --> 00:55:21,603
>> THANK YOU VERY MUCH,
TARA AND

1680
00:55:21,603 --> 00:55:22,704
ABBY, AND THANK YOU TO THOSE WHO

1681
00:55:22,704 --> 00:55:24,339
WERE ABLE TO JOIN US TODAY.

1682
00:55:24,339 --> 00:55:25,807
AS MENTIONED, WE ARE GOING TO

1683
00:55:25,807 --> 00:55:27,475
RECORD THIS AND KEEP THIS UP AND

1684
00:55:27,475 --> 00:55:30,645
AVAILABLE FOR OTHERS TO LEARN

1685
00:55:30,645 --> 00:55:32,414
MORE.

1686
00:55:32,414 --> 00:55:34,115
OUR RFI CLOSES JULY 22ND, SO

1687
00:55:34,115 --> 00:55:35,417
PLEASE, PLEASE, PLEASE SUBMIT

1688
00:55:35,417 --> 00:55:36,651
ANY COMMENTS AND SUGGESTIONS ON

1689
00:55:36,651 --> 00:55:38,520
HOW TO MAKE THIS THE STRONGEST

1690
00:55:38,520 --> 00:55:39,087
PROPOSAL POSSIBLE.

1691
00:55:39,087 --> 00:55:40,422
I THINK WE ARE ALL REALLY

1692
00:55:40,422 --> 00:55:41,756
INTERESTED IN MAKING SURE THAT

1693
00:55:41,756 --> 00:55:43,291
NIH IS THE WORLD'S LARGEST

1694
00:55:43,291 --> 00:55:46,061
FUNDER OF BIOMEDICAL RESEARCH TO

1695
00:55:46,061 --> 00:55:48,363
REALLY SHARE OUR COMMITMENT TO

1696
00:55:48,363 --> 00:55:49,264
TRANSFORM KNOWLEDGE INTO

1697
00:55:49,264 --> 00:55:50,298
IMPROVED HEALTH FOR ALL, AND

1698
00:55:50,298 --> 00:55:51,166
THIS IS ONE IMPORTANT WAY IN

1699
00:55:51,166 --> 00:55:52,500
WHICH WE ARE CONSIDERING TAKING

1700
00:55:52,500 --> 00:55:53,802
SOME ACTION AND COULD BENEFIT

1701
00:55:53,802 --> 00:55:55,170
FROM YOUR PERSPECTIVES IN MAKING

1702
00:55:55,170 --> 00:55:56,571
THIS AS STRONG AS POSSIBLE.

1703
00:55:56,571 --> 00:55:57,906
SO THANK YOU FOR JOINING US

1704
00:55:57,906 --> 00:55:58,440
TODAY.

1705
00:55:58,440 --> 00:56:00,141
WE LOOK FORWARD TO HEARING YOU

1706
00:56:00,141 --> 00:56:01,710
FROM YOU SOON, AND WE'LL BE IN

1707
00:56:01,710 --> 00:56:12,220
TOUCH WITH MORE AS WE PROCEED.