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>>WELCOME

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TO THE OPEN SESSION OF THE

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DIVISION OF MICROBIOLOGY AND

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INFECTIOUS DISEASE SUBCOMMITTEE

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COUNCIL. OUR AGENDA IS ON THIS

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SLIDE.  I'LL GIVE A BRIEF

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PERSONNEL UPDATE, INTRODUCE BY

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SLIDE SOME NEW STAFF. I WILL

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GIVE SOME HIGHLIGHTS FROM DMID

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FUNDED RESEARCH THAT'S BEEN IN

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THE NEWS SINCE LAST TIME WE MET.

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WE'LL HAVE A PRESENTATION BY DR.

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EWE ZIKA HEWITT WHO IS DEPUTY

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DIRECTOR OF PRE-CLINICAL

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SERVICES BECAUSE THAT IS BUNDLE

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OF OUR INITIATIVES FOR CONCEPT

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CLEARANCE THIS AFTERNOON AND

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THERE WERE QUESTIONS RAISED HOW

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DOES THIS SYSTEM WORK AND FIT

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TOGETHER SO WE THOUGHT THAT

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BACKGROUND WOULD BE USEFUL TO

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FRAME THE DISCUSSI DISCUSSION. L

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YEAR 25 CONCEPTS CLEARANCE. SO

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THEN WE WILL HAVE THE FOUR

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INITIATIVES, DMID INITIATIVES

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PRESENTED T THAT ARE LISTED ON

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THIS SLIDE, FOLLOWED BY A

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CONCEPT CLEARANCE REQUESTED FOR

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THE OFFICE OF DATA SCIENCE AND

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EMERGING TECHNOLOGIES THAT WILL

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BE PRESENTED BY DR. REEDE

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SHABMAN AT THE END. SO THIS IS

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OUR AGENDA THIS AFTERNOON. FIRST

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OF ALL, IN THE OPEN SESSION

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REMARKS OF THE NIAID COUNCIL

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EARLIER TODAY YOU HEARD ABOUT

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THE RETIREMENT OF MARK SHULBURG,

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MARK WAS AN EMPLOYEE OF NIAID

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FOR OVER 37 YEARS WHICH IS

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REMARKABLE FOR THE INTRAMURAL

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PROGRAM WHERE HE WORKED IN THE

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LAB WITH DIRECTED BY BERNIE MOSS

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THEN CAME TO NIAID EXTRAMURAL

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DMID A FEW YEARS, PROBABLY STILL

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BEEN DECADES BUT HE -- I VALUED

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IN THE YEARS HE WAS VIROLOGY

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BRANCH CHIEF ABOUT THREE YEARS I

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VALUED HIS UNPUT AND DISCUSSIONS

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I HAD WITH HIM ON SOME BIGGEST

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CHALLENGES LIKE HBV CURE,

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GETTING A VACCINE FOR HEPATITIS

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C. DEVELOPING A VACCINE FOR ZIKA

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SO WE ARE GOING TO MISS MARK BUT

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WE ARE HAPPY GENE PATTERSON IS

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IN PLACE AND IS GOING TO TAKE ON

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THE ROLE OF ACTING VIROLOGY

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BRANCH CHIEF. SO WITH HER OWN

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NAME ON THE TENT IN FRONT OF HER

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AT THE TABLE HERE AND LOOK

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FORWARD TO WHAT GENE CONTINUES

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TO DO FOR DMID AND LEADERSHIP

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FOR THE UPCOMING YEARS. WE HAVE

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A FEW NEW STAFF TO MENTION THAT

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HAVE COME ON BOARD SINCE LAST

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TIME WE MET. CHRISTIAN GONZALES

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IS A PRODUCT DEVELOPMENT

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SPECIALIST, PRODUCT DEVELOPMENT

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PROGRAM MANAGER WHO IS MOVING

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FROM ESTIB TO THE RESPIRATORY

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DISEASE BRANCH. NOT REALLY NEW

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BUT A TRANSITION. NEW ROLE. 

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ROCHELLE SMITH IS A PRESIDENTIAL

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MANAGEMENT FELLOW ACCEPTING A

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POSITION IN THE VIROLOGY BRANCH

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WHERE SHE WILL WORK WITH THE

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CREED NETWORK. SHE STILL IS A

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PNF BUT SHE IS OVER THE NEXT

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MONTH MOVE INTO A FULL TIME

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POSITION WITH US. SHE GRADUATE

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WITH A Ph.D. IN CHEMISTRY FROM

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OREGON STATE UNIVERSITY AND MOST

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OF HER PRESIDENTIAL MANAGEMENT

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FELLOWSHIP EXPERIENCE WAS WITH

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NCI. THEN THE LAST NEW MEMBER OF

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OUR TEAM IS DR. WILL SEARS WHO

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JOINED THE OFFICE OF CLINICAL

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RESEARCH RESOURCES, LAST MONTH

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AND HE COMES TO US AFTER HE

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FINISHED HIS INFECTIOUS DISEASE

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FELLOWSHIP AT NIAID BUT WORKING

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IN THE DIVISION OF INTRAMURAL

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RESEARCH. WILL IS COMBINED

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PHYSICIAN, HE DID A COMBINED

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MEDICINE PEDIATRIC RESIDENCY AT

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INDIANA UNIVERSITY AND HIS

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RESEARCH AT NIAID DURING HIS

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FELLOWSHIP WAS CONDUCTED DONOR

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THE LAB OF TOM (INAUDIBLE) IN

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THE LAB OF PARACYTIC DISEASE. HE

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WORKED IMMUNE RESPONSE WORKING

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ON EOSINOPHILIC MENINGITIS AND

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DIAGNOSTICS AND GENOMICS OF MANY

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DIFFERENT HELMETS SO HIS FOCUS

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WILL BE ON DEVELOPING SKILLS IN

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CLINICAL TRIALS AND

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PARACYTOLOGY. SO NOW I WILL MOVE

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TO NEWS. YOU HEARD FROM DR.

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AUCHINCLOSS THE NEW INSTITUTE

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DIRECTOR WELCOMING SOON IS DR.

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(INAUDIBLE). THOSE COMING TO

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THESE MEETINGS AT LEAST A YEAR

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MIGHT RECALL THAT A YEAR AGO SHE

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PRESENTED BY ZOOM THOUGHTS ON UT

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PRIORITIES AND SEXUALL THAT'S

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THE TESTING OF THE ME

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JINKCOCCAUL MEMBRANE THAT -- IN

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THE BEXE ARE, ARER TRIAL AND

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PROTECTED MEASURE AGAINST

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GONORRHEA. SHE HAS BROAD

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BACKGROUND IN NON-HIV SEXUALLY

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TRANSMITTED INFECTION AND HIV.

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SHE ALSO SEVERAL YEARS AGO

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CONCLUDED THE VOICE TRIAL WHICH

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WAS A TRIAL RECRUITING WOMEN IN

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SUB-SAHARAN AFRICA TO BE

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RANDOMIZED ON TO M ON TA MOVE VD

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MICROBE SIDES.  SHE'S WELL KNOWN

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TO DIVISION OF AIDS AND TO THE

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DIVISION OF MICROBIOLOGY

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INFECTIOUS DISEASE.  SHE'S IN

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LEADERSHIP OF OUR INFECTIOUS

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DISEASE CLINICAL RESEARCH

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CONSORTIUM. SO WE ARE VERY

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EXCITED SHE'S COMING AND HAS

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INTEREST IN OUR SCIENCE. AND WE

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ARE REALLY LOOKING FORWARD TO

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THE NEXT ERA OF NIAID MOVING

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RESEARCH FORWARD INTO HER

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LEADERSHIP. SO JUST A FEW OTHER

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RESULTS THAT HAVE COME OUT

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RECENTLY, WE CONTINUED TO

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PUBLISH ON THE RESULTS OF THE

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COVALE TRIAL WHICH I MENTIONED

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BEFORE IN THESE AFTERNOON

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SESSIONS OF THE DMID SUB COUNCIL

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MEETINGS. THERE IS A RECENT

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PUBLICATION IN NATURE MEDICINE

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THAT -- THIS WAS A TRIAL

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DESIGNED TO COMPARE ALL -- MANY

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DIFFERENT COMBINATIONS OF

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BIVALENT AND MONOVALENT SARS

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COV-2 VARIANT VACCINES.  SOME OF

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THE DATA GENERATED THROUGH THIS

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TRIAL LED TO THE REALIZATION

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THAT AT THE CURRENT TIME WE NO

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LONGER NEEDED TO INCLUDE THE

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PROTOTYPE VACCINE, THE PROTOTYPE

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VALENT IN FUTURE UPDATED

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VACCINES. SO THIS LED TO THE

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DECISION IN PART THIS LED TO THE

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DECISION FOR THE NEXT UPDATED

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VACCINE TO BE MONOVALENT

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DERIVATIVE OF OMICRON. THEN WE

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CONTINUE TO HAVE A LOT OF

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EFFORTS FOCUSED ON SARS COV-2.

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THERE ALWAYS WAS A REPORT COMING

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OUT OF -- COMING IN NATURE

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COMMUNICATIONS FROM OHIO STATE

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UNIVERSITY, INVESTIGATORS THAT

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INTERESTINGLY WE KNOW THAT THIS

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VIRUS IS EVOLVING AND CHANGING.

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AND WE KNOW THAT THERE IS ALWAYS

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POTENTIAL FOR MORE ZOONOTICS

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EVENTS FROM BACK INTO HUMAN SO

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IT WAS INTERESTING TO NOTE THE

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FINDING THERE IS A LOT OF WHITE

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TAIL DEER INFECTED WITH SARS

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COV-2 AND SEEMS AS THOUGH THE

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VIRUS EVOLVES MUTATES AN EVOLVES

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TO NEW VARIANTS THREE TIMES

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FASTER THAN THEY DO IN PEOPLE. 

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SO ALWAYS POTENTIAL FOR LEARNING

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NEW THINGS AND THERE MIGHT BE

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NEW RESERVOIRS FOR NEW SPILL

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OVER EVENTS OUT THERE THAT WE

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NEED TO CONTINUE TO WATCH. SO

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THIS IS JUST AN INTERESTING

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LICENSURE OF A DMID, A VACCINE

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FORELIMB DISEASE THAT DMID

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SUPPORTED THE DEVELOPMENT OF.

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BUT IT IS DIFFERENT THAN THE

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WAYS WE HISTORICALLY -- THAN THE

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TARGET OF OUR MUTUAL VACCINES. 

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THE USDA, NOT THE FDA, THE

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UNITED STATES DEPARTMENT OF

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AGRICULTURE CONDITIONALLY

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LICENSED A VACCINE FOR BAITING

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MICE DESIGNED TO INTERRUPT THE

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TRANSMISSION CYCLE OF

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(INAUDIBLE). DMID SUPPORTED

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INVESTIGATORS WORKING ON THIS

202
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FOR OVER A DECADE.  THE IDEA IS

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THIS IS -- THIS INFECTION, THIS

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PATHOGEN HAS A COMPLICATED LIFE

205
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CYCLE M. MAJOR IMPLICATION --

206
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AMPLIFICATION STEP IN NATURE IS

207
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THE WHITE FOOTED DEER MOUSE

208
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WHICH IS SHOWN THERE ON THE --

209
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IN THE RIGHT PANEL. THE REASON

210
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THAT THAT IS SUCH AN IMPORTANT

211
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AMPLIFICATION STEP YOU CAN LOOK

212
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AT THE MIMPS ON THE EAR OF THE

213
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MOUSE. NYNPH IN THE GRASS WITH

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THE BABY MICE RUNNING AROUND OR

215
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ADULT MICE RUNNING AROUND,

216
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ATTACHES TO A BODY PART THE EAR

217
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DOESN'T HAVE A LOT OF HAIR SO

218
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EASY TO LATCH ON TO. IF THE

219
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MOUSE IS -- MICE BECOME

220
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CHRONICALLY SPY ROW KITEMIC SO

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THE BLOOD FEED OF THE NYNPM

222
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WHICH IS THE EXCODE OF THE TICK,

223
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GAVE US THE LYM DISEASE, THEY

224
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PICK IT UP BECAUSE THEY LAND AND

225
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START FEEDING ON THE BLOOD OF

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INFECTED MOUSE THEY BECOME

227
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INFECTED THEMSELVES, AND THEN

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PROGRESS TO ADULT TICK THAT CAN

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BITE A HUMAN OR CAN BITE A DEER.

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AND TRANSMIT LYM DISEASE. THE

231
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IDEA HERE IS THAT VACCINATING

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THE MICE WITH THIS ORAL BAIT BY

233
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SETTING TRAPS LIKE THAT AROUND

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THE PERIMETER OF YOUR HOUSE OR

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WHEREVER MICE ARE, YOU CAN

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REDUCE THE SPY ROW KEITH IN THE

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THE MOUSE TRANSLATION AND

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PERHAPS INTERRUPT THE

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TRANSLATION OF THE

240
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(INDISCERNIBLE) TO HUMANS.  

241
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THERE IS DATA THAT SUPPORTED

242
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THIS, THROUGH GRANTS WE FUNDED

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AND WE ARE HOPEFUL THAT WE

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CONTINUE TO MOVE THINGS FORWARD

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IN THIS AREA PREVENTING LIME

246
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DISEASE, THERE IS ALSO A HUMAN

247
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VACCINE IN DEVELOPMENT IN THE

248
00:11:01,080 --> 00:11:05,040
PRIVATE SECTOR SO HOPEFULLY WITH

249
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THAT IF THAT MOVES FORWARD TO

250
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LICENSURE THAT IS MORE TOOLS IN

251
00:11:08,920 --> 00:11:11,360
THE TOOLBOX TO PREVENT SPREAD OF

252
00:11:11,360 --> 00:11:12,760
LIME DISEASE.  IN THE PAST FEW

253
00:11:12,760 --> 00:11:15,160
MONTHS WE MADE NEW AWARDS TO

254
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DEVELOP COHORT. TO ACCELERATE

255
00:11:17,600 --> 00:11:19,080
DIAGNOSE -- DEVELOPMENT OF

256
00:11:19,080 --> 00:11:21,200
DIAGNOSTICS AND VACCINES FOR

257
00:11:21,200 --> 00:11:23,440
BACTERIAL SEXUALLY TRANSMITTED

258
00:11:23,440 --> 00:11:27,200
INFECTION. THESE FOCUSED ON

259
00:11:27,200 --> 00:11:30,640
CHLAMYDIA, GONEEE AND SYPHILIS. 

260
00:11:30,640 --> 00:11:34,480
I THINK THAT IS IMPORTANT TO --

261
00:11:34,480 --> 00:11:38,600
THIS IS AN UNDERSERVED NEGLECTED

262
00:11:38,600 --> 00:11:39,840
AREA PARTICULARLY THAT DISEASE

263
00:11:39,840 --> 00:11:45,480
OF SYPHILIS, SO WE ARE HOPEFUL

264
00:11:45,480 --> 00:11:47,080
DISCOVERIES THAT COME OUT OF

265
00:11:47,080 --> 00:11:48,400
COHORT TO MAKE MORE PROGRESS IN

266
00:11:48,400 --> 00:11:56,720
THIS AREA. WE CONTINUE TO BE

267
00:11:56,720 --> 00:11:59,120
CONCERNED ABOUT THE HIGH PATH

268
00:11:59,120 --> 00:12:01,320
AVIAN INFLUENZA A VIRUS

269
00:12:01,320 --> 00:12:05,120
CIRCULATING AROUND THE GLOBE OUR

270
00:12:05,120 --> 00:12:06,960
CREED NETWORK WORKED IN

271
00:12:06,960 --> 00:12:08,960
COLLABORATION WITH OUR SERE

272
00:12:08,960 --> 00:12:12,160
NETWORK BEING FOCUSED ON

273
00:12:12,160 --> 00:12:13,840
INFLUENZA. TO CHARACTERIZE THE

274
00:12:13,840 --> 00:12:15,640
VIRUSES THAT SEEM TO BE KILLING

275
00:12:15,640 --> 00:12:19,280
MARINE MAMMALS ON THE COAST OF

276
00:12:19,280 --> 00:12:22,360
PERU. THEY FOUND THAT THE

277
00:12:22,360 --> 00:12:23,440
VIRUSES WERE RAPID WILL I

278
00:12:23,440 --> 00:12:25,400
OCCURRING MUTATIONS, TRY TO

279
00:12:25,400 --> 00:12:27,800
CHARACTERIZE IN A WAY TO

280
00:12:27,800 --> 00:12:29,440
IDENTIFY THE ADAPTATIONS THAT

281
00:12:29,440 --> 00:12:32,560
SEEM PARTICULARLY DANGEROUS FOR

282
00:12:32,560 --> 00:12:36,440
MAMMALS SO WE CAN PREDICT --

283
00:12:36,440 --> 00:12:37,960
IDENTIFY IN ADVANCE WHAT MIGHT

284
00:12:37,960 --> 00:12:41,440
BE A THREAT TO HUMANS. THIS WAS

285
00:12:41,440 --> 00:12:42,480
IMPORTANT RESEARCH, THIS

286
00:12:42,480 --> 00:12:48,200
CONTINUES TO BE A PROBLEM THAT

287
00:12:48,200 --> 00:12:49,680
EGG SHORTAGE EARLIER IN THE YEAR

288
00:12:49,680 --> 00:12:52,360
SOMETHING THAT PASSED BUT

289
00:12:52,360 --> 00:12:54,440
CONTINUE TO BE A THREAT TO

290
00:12:54,440 --> 00:12:56,600
POTENTIAL THREAT TO HUMAN HEALTH

291
00:12:56,600 --> 00:12:59,960
THIS TYPE INFLUENZA, H 5N 1

292
00:12:59,960 --> 00:13:02,200
STILL CIRCULATING AROUND THE

293
00:13:02,200 --> 00:13:03,760
GLOBE. THIS WAS SOMETHING DR.

294
00:13:03,760 --> 00:13:05,320
AUCHINCLOSS MENTIONED IN HIS

295
00:13:05,320 --> 00:13:07,160
REMARKS EARLIER TODAY. THERE IS

296
00:13:07,160 --> 00:13:10,840
A REGUEST FOR INFORMATION

297
00:13:10,840 --> 00:13:15,280
PUBLISHED LAST WEEK ON CHANGES

298
00:13:15,280 --> 00:13:17,560
TO THE POLICY FOR OVERSIGHT OF

299
00:13:17,560 --> 00:13:22,000
DUAL USE RESEARCH OF CONCERN.

300
00:13:22,000 --> 00:13:23,920
AND POTENTIAL PANDEMIC PATHOGEN

301
00:13:23,920 --> 00:13:27,440
OVERSIGHT, THE P 3CO POLICY

302
00:13:27,440 --> 00:13:31,080
FRAMEWORK. THIS IS THE EFFORT TO

303
00:13:31,080 --> 00:13:35,320
REVISE THESE POLICIES WAS

304
00:13:35,320 --> 00:13:37,160
PRIMARILY UNDER -- IT WAS

305
00:13:37,160 --> 00:13:38,000
RESPONSIBILITY ASSIGNED TO

306
00:13:38,000 --> 00:13:39,480
OFFICE OF SCIENCE AND

307
00:13:39,480 --> 00:13:43,280
TECHNOLOGY, OSTP OUT OF THE

308
00:13:43,280 --> 00:13:44,680
WHITE HOUSE AND NATIONAL

309
00:13:44,680 --> 00:13:49,120
SECURITY COUNCIL. THE PROPOSED

310
00:13:49,120 --> 00:13:50,960
POLICY WILL EXPAND PRETTY

311
00:13:50,960 --> 00:13:51,920
SIGNIFICANTLY THE NUMBER OF

312
00:13:51,920 --> 00:13:54,960
PATHOGENS THAT HAVE TO BE ON THE

313
00:13:54,960 --> 00:13:56,520
DURC WATCH LIST. THIS IS MY READ

314
00:13:56,520 --> 00:13:58,600
OF THE DRAFT POLICY, THE DRAFT

315
00:13:58,600 --> 00:14:02,040
POLICY ISN'T PUBLISHED IN THE

316
00:14:02,040 --> 00:14:03,400
FEDERAL GUIDE OR FEDERAL

317
00:14:03,400 --> 00:14:05,000
REGISTRY BUT A LOT OF QUESTIONS

318
00:14:05,000 --> 00:14:09,360
ON AREAS OF -- THAT MIGHT BE

319
00:14:09,360 --> 00:14:12,280
UNCLEAR OR DIFFICULT TO

320
00:14:12,280 --> 00:14:14,080
IMPLEMENT ARE TARGETED QUESTIONS

321
00:14:14,080 --> 00:14:18,520
ARE ASKED SO BY OCTOBER 16TH

322
00:14:18,520 --> 00:14:20,200
OSTP AND THE NATIONAL SECURITY

323
00:14:20,200 --> 00:14:22,280
COUNCIL WOULD LIKE TO GET INPUT

324
00:14:22,280 --> 00:14:24,000
FROM THE SCIENTIFIC COMMUNITY,

325
00:14:24,000 --> 00:14:27,720
PEOPLE THAT ARE INVOLVED IN

326
00:14:27,720 --> 00:14:28,920
BIOSAFETY AT THE INSTITUTIONAL

327
00:14:28,920 --> 00:14:31,960
LEVEL AND INVESTIGATORS WHO WORK

328
00:14:31,960 --> 00:14:34,800
WITH SOME OF THESE PATHOGENS TO

329
00:14:34,800 --> 00:14:37,200
GET INPUT HOW THIS POLICY MAYBE

330
00:14:37,200 --> 00:14:39,000
COULD BE IMPROVED TO MAKE IT

331
00:14:39,000 --> 00:14:40,360
WORKABLE IN MANY THE FUTURE. SO

332
00:14:40,360 --> 00:14:41,720
THAT'S OUT THERE. IT IS

333
00:14:41,720 --> 00:14:44,280
IMPORTANT. IF YOU DON'T THINK

334
00:14:44,280 --> 00:14:46,600
YOU ARE A STAKEHOLDER, YOUR

335
00:14:46,600 --> 00:14:48,600
INSTITUTIONAL BIOSAFETY

336
00:14:48,600 --> 00:14:50,200
COMMITTEE MIGHT WANT TO BE --

337
00:14:50,200 --> 00:14:53,720
YOU MIGHT POINT THEM TO THIS RFI

338
00:14:53,720 --> 00:14:55,680
SO THAT POLICY THAT COMES OUT ON

339
00:14:55,680 --> 00:14:57,720
THE OTHER SIDE TO BE IMPLEMENTED

340
00:14:57,720 --> 00:15:00,760
NEXT YEAR IS THE BEST IN TERMS

341
00:15:00,760 --> 00:15:02,520
OF BIOSECURITY BIOSAFETY AND

342
00:15:02,520 --> 00:15:05,840
SUPPORT IT IS BEST SITES.  SO

343
00:15:05,840 --> 00:15:12,440
THAT CONCLUDES MY REMARKS. I

344
00:15:12,440 --> 00:15:14,360
WILL HAND OFF THE PODIUM TO DR.

345
00:15:14,360 --> 00:15:15,720
JUDY HEWITT WHO WILL TALK ABOUT

346
00:15:15,720 --> 00:15:17,840
WHO WILL GIVE BACKGROUND ON

347
00:15:17,840 --> 00:15:19,840
PRE-CLINICAL SERVICES, THE SUITE

348
00:15:19,840 --> 00:15:21,520
OF PRE-CLINICAL SERVICES THAT

349
00:15:21,520 --> 00:15:31,800
DMID SUPPORTS. 

350
00:15:34,520 --> 00:15:36,480
>>THANK YOU, EMILY.
APPRECIATE

351
00:15:36,480 --> 00:15:40,920
YOU MAKING TIME IN THE AGENDA

352
00:15:40,920 --> 00:15:46,680
FOR US. SO I WILL START BY

353
00:15:46,680 --> 00:15:48,240
DESCRIBING OUR PRE-CLINICAL

354
00:15:48,240 --> 00:15:49,720
SERVICES AND THE TITLE OF THIS

355
00:15:49,720 --> 00:15:51,640
SLIDE ALSO INCLUDES RESEARCH

356
00:15:51,640 --> 00:15:53,000
RESOURCES AND WE WILL GET INTO

357
00:15:53,000 --> 00:15:56,240
THAT IN A SECOND. THE POINT IS

358
00:15:56,240 --> 00:15:57,880
THAT TO PROVIDE A SUITE OF

359
00:15:57,880 --> 00:16:00,800
CAPABILITIES TO ADDRESS PRODUCT

360
00:16:00,800 --> 00:16:06,120
DEVELOPMENT GAPS. ALONG THE

361
00:16:06,120 --> 00:16:09,760
BOTTOM WE HAVE CONSIDER RESEARCH

362
00:16:09,760 --> 00:16:11,360
RESOURCE, PRE-CLINICAL MODELS OF

363
00:16:11,360 --> 00:16:12,120
INFECTIOUS DISEASE THAT CAME AS

364
00:16:12,120 --> 00:16:14,560
A CONCEPT TO YOU, I THINK TWO

365
00:16:14,560 --> 00:16:17,200
YEARS AGO, AS WELL AS THE BEI

366
00:16:17,200 --> 00:16:19,440
RESOURCES RESEARCH -- RESOURCE

367
00:16:19,440 --> 00:16:20,800
REPOSITORY. SO YOU HAVE APPROVED

368
00:16:20,800 --> 00:16:23,520
THOSE AND THOSE ARE IN THE

369
00:16:23,520 --> 00:16:27,040
PROCESS OF BEING AWARDED.  THEN

370
00:16:27,040 --> 00:16:28,720
WE HAVE VARIOUS SERVICES FOR

371
00:16:28,720 --> 00:16:30,280
THERAPEUTICS, VACCINES, OR

372
00:16:30,280 --> 00:16:34,840
DIAGNOSTICS.  SO THE

373
00:16:34,840 --> 00:16:36,600
BIOPHARMACEUTICAL PRODUCTS IS

374
00:16:36,600 --> 00:16:38,560
ALSO BEING AWARDED AS WE SPEAK.

375
00:16:38,560 --> 00:16:39,720
SO YOU HAVE HEARD THAT WITHIN

376
00:16:39,720 --> 00:16:42,720
THE PAST TWO YEARS. IN VITRO

377
00:16:42,720 --> 00:16:44,160
ASSESSMENT OF ANTIMICROBIAL

378
00:16:44,160 --> 00:16:45,600
ACTIVITY WILL COME TO YOU NEXT

379
00:16:45,600 --> 00:16:50,160
YEAR. THEN TODAY YOU ARE GOING

380
00:16:50,160 --> 00:16:52,600
TO HEAR ABOUT THREE SPECIFIC

381
00:16:52,600 --> 00:16:54,240
CONCEPTS THE NON-CLINICAL

382
00:16:54,240 --> 00:16:55,600
SERVICES FOR INTERVENTIONAL

383
00:16:55,600 --> 00:16:57,240
AGENTS AS WELL AS VACCINE

384
00:16:57,240 --> 00:16:59,880
EVALUATION AND TESTING AND

385
00:16:59,880 --> 00:17:01,440
MANUFACTURING. SO I WON'T SAY

386
00:17:01,440 --> 00:17:03,680
ANYTHING MORE ABOUT THOSE. THEN

387
00:17:03,680 --> 00:17:06,440
LASTLY, WE NEED TO POINT OUT

388
00:17:06,440 --> 00:17:08,240
THIS YEAR WE AWARDED A

389
00:17:08,240 --> 00:17:09,440
PRE-CLINICAL SERVICE PROGRAM FOR

390
00:17:09,440 --> 00:17:10,920
DIAGNOSTICS. SO THIS IS BRAND

391
00:17:10,920 --> 00:17:15,840
NEW, WE ARE LOOKING TO SOLICIT

392
00:17:15,840 --> 00:17:18,600
REQUESTS FROM THE RESEARCH

393
00:17:18,600 --> 00:17:20,360
COMMUNITY WHERE THEY NEED HELP

394
00:17:20,360 --> 00:17:23,800
DEVELOPING DIAGNOSTICKICS. SO

395
00:17:23,800 --> 00:17:25,160
BRIEFLY I WILL MENTION THAT,

396
00:17:25,160 --> 00:17:26,800
HELP WITH PRODUCT DEVELOPMENT

397
00:17:26,800 --> 00:17:29,680
PROCESSES, IMMUNOASSAYS, SAMPLE

398
00:17:29,680 --> 00:17:32,680
PREP VARIOUS CAPABILITIES LIKE

399
00:17:32,680 --> 00:17:34,240
THAT. ALL THESE SERVICES WERE

400
00:17:34,240 --> 00:17:38,200
SET UP IN P RESPONSE TO

401
00:17:38,200 --> 00:17:40,840
BIODEFENSE INITIATIVES EARLY ON

402
00:17:40,840 --> 00:17:44,240
PREACCEPT AT A TIMED BY AD

403
00:17:44,240 --> 00:17:45,840
EVENTS OF 22 YEARS AGO TODAY AND

404
00:17:45,840 --> 00:17:47,520
THE ANTHRAX LETTERS, AS THEY

405
00:17:47,520 --> 00:17:50,520
WERE RECOMPETED THEY BECAME LESS

406
00:17:50,520 --> 00:17:51,720
FOCUSED ON BIODEFENSE AND

407
00:17:51,720 --> 00:17:53,840
FOCUSED ON PATHOGENS THAT DMID

408
00:17:53,840 --> 00:18:00,880
WORKS ON. THESE ARE AVAILABLE TO

409
00:18:00,880 --> 00:18:03,800
FOR ALL CAPABILITIES. WE ALWAYS

410
00:18:03,800 --> 00:18:06,200
USE THESE PRE-CLINICAL SERVICES

411
00:18:06,200 --> 00:18:07,240
WHENEVER THERE WERE IS AN

412
00:18:07,240 --> 00:18:10,360
OUTBREAK SO WANTED TO HIGHLIGHT

413
00:18:10,360 --> 00:18:13,880
THAT NOT ONLY HELPING THE

414
00:18:13,880 --> 00:18:16,720
DEVELOPERS IT IS PART OF OUR

415
00:18:16,720 --> 00:18:22,720
RESPONSE EFFORT TO EVALUATION OF

416
00:18:22,720 --> 00:18:23,760
INTERVENTIONS WHEN THERE IS AN

417
00:18:23,760 --> 00:18:25,400
OUTBREAK. SO THE PRE-CLINICAL

418
00:18:25,400 --> 00:18:29,840
SERVICES OBVIOUSLY PROVIDE

419
00:18:29,840 --> 00:18:31,360
PRE-CLINICAL SERVICES BUT I WANT

420
00:18:31,360 --> 00:18:32,400
TO HIGHLIGHT OTHERS THINGS THEY

421
00:18:32,400 --> 00:18:39,400
DO SO THEY LOWER THE RISK FOR

422
00:18:39,400 --> 00:18:44,760
DEVELOPERS WE PROVIDE EXPERTISE

423
00:18:44,760 --> 00:18:45,680
CAPABILITY AND PRODUCT

424
00:18:45,680 --> 00:18:46,680
DEVELOPMENT FROM OUR STAFF

425
00:18:46,680 --> 00:18:52,920
EXPERTISE AND CAPABILITY THE

426
00:18:52,920 --> 00:18:53,960
PROPERTY TORRS PERFORMING THESE

427
00:18:53,960 --> 00:18:56,600
SERVICES PROVIDE ADDITIONAL

428
00:18:56,600 --> 00:18:57,600
CAPABILITIES AND THE

429
00:18:57,600 --> 00:18:58,400
CAPABILITIES PERFORMING THE

430
00:18:58,400 --> 00:19:02,920
WORK. WE HOPE TO MOVE PROMISING

431
00:19:02,920 --> 00:19:04,240
DISCOVERIES ALONG THE PRODUCT

432
00:19:04,240 --> 00:19:07,440
DEVELOPMENT PATHWAY.  THIS IS

433
00:19:07,440 --> 00:19:10,560
INTENDED TO BE A GAP FILLING

434
00:19:10,560 --> 00:19:13,000
SERVICE, NOT INTENDED TO BE A

435
00:19:13,000 --> 00:19:14,840
FULL PRODUCT DEVELOPMENT PROGRAM

436
00:19:14,840 --> 00:19:17,080
SOUP TO NUTS, REALLY OUR INTENT

437
00:19:17,080 --> 00:19:18,800
IS THAT WE CAN HELP

438
00:19:18,800 --> 00:19:22,080
INVESTIGATORS OUT, GET THEM SOME

439
00:19:22,080 --> 00:19:24,120
CRITICAL KEY PIECES OF DATA TO

440
00:19:24,120 --> 00:19:25,440
ATTRACT FUNDING FROM OTHER

441
00:19:25,440 --> 00:19:29,040
SOURCES.  LASTLY, WHEN WE

442
00:19:29,040 --> 00:19:30,800
PERFORM THESE SERVICES WE DO IT

443
00:19:30,800 --> 00:19:35,320
UNDER AGREEMENTS THAT ASSURE THE

444
00:19:35,320 --> 00:19:37,240
CONFIDENTIALITY AND PROTECT

445
00:19:37,240 --> 00:19:39,520
INTELLECTUAL PROPERTY OF THE WHO

446
00:19:39,520 --> 00:19:45,280
PRODUCT DEVELOPER. SO THIS SLIDE

447
00:19:45,280 --> 00:19:48,560
SUMMARIZES WHO IS ELIGIBLE. EVE

448
00:19:48,560 --> 00:19:51,080
INNOVATORS FROM ACADEMIA,

449
00:19:51,080 --> 00:19:54,000
NON-PROFIT INDUSTRY AND

450
00:19:54,000 --> 00:19:56,280
GOVERNMENT. INDUSTRY IN TERMS OF

451
00:19:56,280 --> 00:19:57,920
AGREEMENTS WITH VARIOUS

452
00:19:57,920 --> 00:19:58,840
ORGANIZATIONS INDUSTRY TAKES UP

453
00:19:58,840 --> 00:20:01,640
THE BULK OF OUR AGREEMENT,

454
00:20:01,640 --> 00:20:02,920
APPROXIMATELY 55 PERCENT OF OUR

455
00:20:02,920 --> 00:20:05,080
AGREEMENTS ARE WITH INDUSTRY. I

456
00:20:05,080 --> 00:20:09,080
WOULD SAY THAT IS LARGELY SMALL

457
00:20:09,080 --> 00:20:10,520
COMPANIES. THERE ARE

458
00:20:10,520 --> 00:20:12,280
OCCASIONALLY LARGE PHARMA

459
00:20:12,280 --> 00:20:15,200
REQUESTERS. FOLLOWED BY

460
00:20:15,200 --> 00:20:18,360
ACADEMIA, 30% REQUEST COME FROM

461
00:20:18,360 --> 00:20:20,880
ACADEMIC INVESTIGATORS AND

462
00:20:20,880 --> 00:20:22,240
BALANCE FROM INDUSTRY OR OTHER

463
00:20:22,240 --> 00:20:24,480
GOVERNMENT AGENCIES. WE CAN

464
00:20:24,480 --> 00:20:26,320
PROVIDE THESE SERVICES TO BOTH

465
00:20:26,320 --> 00:20:28,040
DOMESTIC AND FOREIGN

466
00:20:28,040 --> 00:20:29,120
INSTITUTIONS, THOUGH FAR AND

467
00:20:29,120 --> 00:20:30,920
AWAY IT WAS LARGELY DOMESTIC. 

468
00:20:30,920 --> 00:20:32,720
THERE IS NOT A REQUIREMENT YOU

469
00:20:32,720 --> 00:20:36,920
HAVE NIH FUNDING TO ACCESS

470
00:20:36,920 --> 00:20:38,840
SERVICES, THE HOPE IS YOU WOULD

471
00:20:38,840 --> 00:20:42,600
USE RESULTS TO ATTRACT NIH

472
00:20:42,600 --> 00:20:44,040
FUNDING. IN A FEW SLIDES I WILL

473
00:20:44,040 --> 00:20:45,520
SHOW YOU SIMPLIFIED REQUEST

474
00:20:45,520 --> 00:20:47,400
PROCESS, WHEN I GET TO THE SLIDE

475
00:20:47,400 --> 00:20:51,400
MAY NOT LOOK IT BUT COMPARED TO

476
00:20:51,400 --> 00:20:56,400
APRYIA-- APPLYING FOR GRANT IT A

477
00:20:56,400 --> 00:20:57,960
SIMPLIFIED PROCESS, AVAILABLE

478
00:20:57,960 --> 00:21:01,800
YEAR ROUND. WE HAVE SOME THIS

479
00:21:01,800 --> 00:21:02,920
LAST BULLET TALKS HOW WE

480
00:21:02,920 --> 00:21:04,160
DETERMINE WHICH PROJECTS TO

481
00:21:04,160 --> 00:21:07,120
SUPPORT. THIS IS VERY HIGH LEVEL

482
00:21:07,120 --> 00:21:08,040
BUT I HAVE ANOTHER SLIDE THAT

483
00:21:08,040 --> 00:21:10,200
GETS INTO A LITTLE MORE DETAIL

484
00:21:10,200 --> 00:21:15,600
ON THAT. SO IT IS IMPORTANT TO

485
00:21:15,600 --> 00:21:17,800
MENTION ALL THE CONTRACTS THAT

486
00:21:17,800 --> 00:21:18,760
PROVIDE PRE-CLINICAL SERVICES

487
00:21:18,760 --> 00:21:21,600
ARE WHAT IS KNOWN AS INDEFINITE

488
00:21:21,600 --> 00:21:23,200
DELIVERY AND DEFINITE --

489
00:21:23,200 --> 00:21:25,240
INDEFINITE QUANTITY OR IDIQ

490
00:21:25,240 --> 00:21:26,840
CONTRACTS. WHAT THAT MEANS IS

491
00:21:26,840 --> 00:21:27,760
THE GOVERNMENT KNOWS WE ARE

492
00:21:27,760 --> 00:21:30,880
GOING TO NEED SOME OF THIS, WE

493
00:21:30,880 --> 00:21:35,480
DON'T KNOW HOW MUCH OR WHEN. SO

494
00:21:35,480 --> 00:21:37,000
WHEN WE BRING CONCEPTS TO YOU IT

495
00:21:37,000 --> 00:21:42,400
IS DEVELOPING A POOL OF

496
00:21:42,400 --> 00:21:45,680
CONTRACTORS WHO CAN PROVIDE

497
00:21:45,680 --> 00:21:47,240
VACCINE TESTING OR

498
00:21:47,240 --> 00:21:48,680
INTERVENTIONAL AGENT TESTING. SO

499
00:21:48,680 --> 00:21:49,920
THEY GET A BASE CONTRACT THAT

500
00:21:49,920 --> 00:21:52,560
ALLOWS US TO PLACE TASK ORDERS

501
00:21:52,560 --> 00:21:54,120
FOR SEVEN YEAR ORDERING PERIOD.

502
00:21:54,120 --> 00:21:55,920
SO THAT BASE CONTRACT IS REALLY

503
00:21:55,920 --> 00:21:56,600
SOMETHING LIKE A FISHING

504
00:21:56,600 --> 00:22:03,880
LICENSE. YOU ARE ALLOWED TO

505
00:22:03,880 --> 00:22:05,000
FISH, DOESN'T MEAN YOU ARE GOING

506
00:22:05,000 --> 00:22:06,680
TO CATCH ANYTHING. SO WHEN WE

507
00:22:06,680 --> 00:22:07,880
HAVE A SPECIFIC REQUEST FOR A

508
00:22:07,880 --> 00:22:11,640
TASK ORDER WE PUT THAT REQUEST

509
00:22:11,640 --> 00:22:13,520
OUT TO THE CONTRACTORS IN THE

510
00:22:13,520 --> 00:22:15,640
POOL, THE CROs THAT HAVE

511
00:22:15,640 --> 00:22:16,680
FISHING LICENSES AND THEY

512
00:22:16,680 --> 00:22:18,040
COMPETE WITH EACH OTHER TO GET

513
00:22:18,040 --> 00:22:24,520
THAT WORK. ALTS THAT POINT WE

514
00:22:24,520 --> 00:22:26,560
ARE FOCUSING ON WHO HAS THE BEST

515
00:22:26,560 --> 00:22:27,760
CAPABILITY TO PERFORM THE

516
00:22:27,760 --> 00:22:28,960
SPECIFIC WORK WE ARE LOOKING TO

517
00:22:28,960 --> 00:22:35,000
CONTRACT.  THEY GET A GUARANTEED

518
00:22:35,000 --> 00:22:36,480
MINIMUM WE USE FOR INITIAL KICK

519
00:22:36,480 --> 00:22:39,840
OFF MEETING.  THEN THERE IS ALSO

520
00:22:39,840 --> 00:22:43,480
A SPECIFIED MAXIMUM VALUE FOR

521
00:22:43,480 --> 00:22:45,480
CONTRACTS WHICH ARE EXTREMELY

522
00:22:45,480 --> 00:22:47,360
LARGE WITH THE HOPE IF

523
00:22:47,360 --> 00:22:50,000
ADDITIONAL MONEY CAME TO US FOR

524
00:22:50,000 --> 00:22:51,280
OUTBREAK RESPONSE FOR EXAMPLE WE

525
00:22:51,280 --> 00:22:52,960
WOULD BE ABLE TO INCREASE THE

526
00:22:52,960 --> 00:22:55,800
VALUE OF THESE CONTRACTS.  SO

527
00:22:55,800 --> 00:22:57,400
THE REAL FUNDING COMES WITH THE

528
00:22:57,400 --> 00:23:00,840
INDIVIDUAL TASK ORDERS AS THEY

529
00:23:00,840 --> 00:23:06,400
COMPETE FOR THOSE.  THIS IS THE

530
00:23:06,400 --> 00:23:08,280
BUSINESS SLIDE. THE TITLE SAYS

531
00:23:08,280 --> 00:23:09,840
PRE-CLINICAL SERVICES PROVIDE

532
00:23:09,840 --> 00:23:11,000
SUPPORT NOT FUNDING SO IT IS

533
00:23:11,000 --> 00:23:13,600
REALLY IMPORTANT TO UNDERSTAND

534
00:23:13,600 --> 00:23:15,560
THIS IS IN KIND SUPPORT FOR THE

535
00:23:15,560 --> 00:23:16,960
EXTERNAL REQUESTERS, WE DON'T

536
00:23:16,960 --> 00:23:19,400
GIVE THEM THE FUNDING DIRECTLY.

537
00:23:19,400 --> 00:23:20,960
WE ARE FUNDING OUR CONTRACTORS

538
00:23:20,960 --> 00:23:26,480
WHO ARE PROVIDING THE SERVICES. 

539
00:23:26,480 --> 00:23:29,440
SO I'M SHOWING AGREEMENTS

540
00:23:29,440 --> 00:23:30,600
VARIOUS STAKEHOLDERS IN THEIR

541
00:23:30,600 --> 00:23:34,240
ROLES AND DELIVERABLES. SO I

542
00:23:34,240 --> 00:23:35,720
WILL START WITH REQUESTER WHO

543
00:23:35,720 --> 00:23:37,160
COMES TO US TO MAKE A REQUEST

544
00:23:37,160 --> 00:23:42,120
FOR A PARTICULAR SERVICE. THEY

545
00:23:42,120 --> 00:23:44,240
TALK WITH DMID STAFF, FREQUENTLY

546
00:23:44,240 --> 00:23:45,280
THEY GO TO PROGRAM OFFICER

547
00:23:45,280 --> 00:23:49,720
FIRST. BUT MIGHT KNOW WHO THE

548
00:23:49,720 --> 00:23:51,360
STAFF RUNNING THE VACCINE

549
00:23:51,360 --> 00:23:52,520
TESTING CONTRACT IS SO THEY

550
00:23:52,520 --> 00:23:54,760
MIGHT APPROACH THAT PERSON, IT

551
00:23:54,760 --> 00:23:57,760
JUST DEPENDS. SO A TEAM OF DMID

552
00:23:57,760 --> 00:23:58,960
PEOPLE GET TOGETHER AND TALK

553
00:23:58,960 --> 00:24:00,200
WITH THAT REQUESTER ABOUT THEIR

554
00:24:00,200 --> 00:24:05,520
REQUEST. WE BRING SUBJECT MATTER

555
00:24:05,520 --> 00:24:08,640
EXPERTS OR SMEs AS NEEDED,

556
00:24:08,640 --> 00:24:11,320
SUCH AS GMP TOX STUDIES OR

557
00:24:11,320 --> 00:24:12,680
MANUFACTURING, WE BRING THAT

558
00:24:12,680 --> 00:24:14,120
EXPERTISE, WE BRING IN

559
00:24:14,120 --> 00:24:15,800
REGULATORY AFFAIRS STAFF NEEDED

560
00:24:15,800 --> 00:24:16,920
DEPENDING ON WHAT THE REQUEST

561
00:24:16,920 --> 00:24:22,040
IS. SO THE DMID TEAM WILL

562
00:24:22,040 --> 00:24:25,040
DISCUSS REQUEST WITH THE

563
00:24:25,040 --> 00:24:26,000
REQUESTER, AND THIS CAN BE

564
00:24:26,000 --> 00:24:28,560
SOMETHING OF ITERATIVE PROCESS.

565
00:24:28,560 --> 00:24:32,760
IF WE THINK WE WANT TO MOVE

566
00:24:32,760 --> 00:24:36,360
AHEAD WE WILL ASK REQUESTER TO

567
00:24:36,360 --> 00:24:38,720
HAVE INSTITUTION SIGN NCEA OR

568
00:24:38,720 --> 00:24:40,400
NON-CLINICAL EVALUATION

569
00:24:40,400 --> 00:24:41,840
AGREEMENT. LIKE A MATERIAL

570
00:24:41,840 --> 00:24:45,240
TRANSFER AGREEMENT. IT SPECIFIES

571
00:24:45,240 --> 00:24:47,640
WHO HAS PUBLICATION RIGHTS,

572
00:24:47,640 --> 00:24:51,200
PROTECTS THE INVESTIGATORS IP,

573
00:24:51,200 --> 00:24:52,120
CONFIDENTIALITY, ALL KINDS OF

574
00:24:52,120 --> 00:24:56,120
THINGS LIKE THAT. THERE IS A

575
00:24:56,120 --> 00:24:58,840
SECOND PART TO THE AGREEMENT

576
00:24:58,840 --> 00:25:00,920
CALLED SRF OR SERVICE REQUEST

577
00:25:00,920 --> 00:25:02,920
FORM WHERE WE GET INTO THE

578
00:25:02,920 --> 00:25:04,160
NITTY-GRITTY OF WHAT IS THE

579
00:25:04,160 --> 00:25:06,120
SERVICE THE REQUESTERS ACTUALLY

580
00:25:06,120 --> 00:25:07,560
REQUESTING AND WHAT WE ARE

581
00:25:07,560 --> 00:25:10,120
AGREEING TO PROVIDE. T MORE THE

582
00:25:10,120 --> 00:25:11,360
SCIENCE TECHNICAL ASPECT OF THE

583
00:25:11,360 --> 00:25:17,840
REQUEST.  SO WHAT HAPPENS WHEN

584
00:25:17,840 --> 00:25:19,520
THERE MIGHT BE SEVERAL

585
00:25:19,520 --> 00:25:20,520
DISCUSSIONS TO COME TO A

586
00:25:20,520 --> 00:25:22,240
DECISION WHAT IS THIS REQUEST

587
00:25:22,240 --> 00:25:24,800
LOOK LIKE AND THEN THE DMID TEAM

588
00:25:24,800 --> 00:25:29,400
WILL PUT TOGETHER A REQUEST FORM

589
00:25:29,400 --> 00:25:31,520
THAT GOES TO WHAT I HAVE CALLED

590
00:25:31,520 --> 00:25:33,400
DMID LEADERSHIP REVIEW I WILL

591
00:25:33,400 --> 00:25:38,200
DESCRIBE IN MORE DETAIL. FIRST

592
00:25:38,200 --> 00:25:39,960
STEP IS GETTING BRANCH CHIEF TO

593
00:25:39,960 --> 00:25:45,040
OKAY IT. THEN IT GOES TO PCS

594
00:25:45,040 --> 00:25:48,600
REVIEW COMMITTEE. MADE UP OF

595
00:25:48,600 --> 00:25:51,240
KRISTINA (INAUDIBLE) THE DEPUTY

596
00:25:51,240 --> 00:25:53,040
DIRECTOR, THE DIRECTOR DEPUTY

597
00:25:53,040 --> 00:25:54,960
DIRECT DOOR AND THREE SCIENTIFIC

598
00:25:54,960 --> 00:25:58,280
SENIOR SCIENTIFIC OFFICERS ONE

599
00:25:58,280 --> 00:25:59,760
FOR VACCINES ONE FOR

600
00:25:59,760 --> 00:26:01,880
THERAPEUTICS AND ONE FOR

601
00:26:01,880 --> 00:26:05,080
DIAGNOSTICS.  THESE ARE

602
00:26:05,080 --> 00:26:05,720
INDEPENDENT FOLKS THAT DON'T

603
00:26:05,720 --> 00:26:07,280
HAVE A GRANT OR CONTRACT

604
00:26:07,280 --> 00:26:09,480
PORTFOLIO OF THEIR OWN BUT THEY

605
00:26:09,480 --> 00:26:10,920
HAVE DEEP EXPERIENCE IN PRODUCT

606
00:26:10,920 --> 00:26:11,960
DEVELOPMENT IN THEIR VARIOUS

607
00:26:11,960 --> 00:26:14,680
AREAS.  SO AS A COMMITTEE WE

608
00:26:14,680 --> 00:26:16,560
DISCUSS THE REQUESTS THAT ARE

609
00:26:16,560 --> 00:26:20,720
BROUGHT TO US EACH WEEK. WE

610
00:26:20,720 --> 00:26:26,040
AGREE WHICH SHOULD MOVE FORWARD 

611
00:26:26,040 --> 00:26:29,040
LASTLY THE DIVISION DIRECTOR DR.

612
00:26:29,040 --> 00:26:32,160
ERBELDING SIGNS OFF REQUESTS WE

613
00:26:32,160 --> 00:26:35,880
PUT FORWARD TO HER. THAT PROCESS

614
00:26:35,880 --> 00:26:37,560
HAPPENS EVERY WEEK. ONCE THE

615
00:26:37,560 --> 00:26:39,520
OKAY IS GIVEN FOR PARTICULAR

616
00:26:39,520 --> 00:26:43,240
PROJECT, SO WHAT THAT OKAY

617
00:26:43,240 --> 00:26:44,800
REALLY GRANTS IS THE FUNDING

618
00:26:44,800 --> 00:26:46,080
ATTACHED TO THAT SPECIFIC

619
00:26:46,080 --> 00:26:50,560
PRODUCT. OR PROJECT. SO WE THEN

620
00:26:50,560 --> 00:26:54,680
ATTACH THAT REQUEST TO A TASK

621
00:26:54,680 --> 00:26:56,240
ORDER. SOMETIMES WE HAVE TASK

622
00:26:56,240 --> 00:26:57,280
ORDERS ALREADY AWARDED AND I

623
00:26:57,280 --> 00:26:59,040
WILL GIVE YOU A GOOD EXAMPLE OF

624
00:26:59,040 --> 00:27:00,480
WHERE WE MIGHT DO THAT,

625
00:27:00,480 --> 00:27:02,520
SOMETHING LIKE A SCREENING TASK

626
00:27:02,520 --> 00:27:04,520
ORDER. SO WHERE WE KNOW WE WANT

627
00:27:04,520 --> 00:27:07,080
TO HAVE SCREENING FOR ANTIVIRALS

628
00:27:07,080 --> 00:27:11,320
FOR SARS COV-2. SO WE SET UP A

629
00:27:11,320 --> 00:27:14,680
TASK ORDER THAT DOES THAT

630
00:27:14,680 --> 00:27:17,520
ACTIVITY. THE APPROVAL COMES AT

631
00:27:17,520 --> 00:27:20,880
THE BRANCH CHIEF LEVEL. IF WE

632
00:27:20,880 --> 00:27:25,200
GET A REQUEST FOR GMP

633
00:27:25,200 --> 00:27:25,800
MANUFACTURING OF THE VACCINE

634
00:27:25,800 --> 00:27:28,200
THAT IS GOING TO COST MORE

635
00:27:28,200 --> 00:27:30,080
MONEY, THEN WE WILL SET UP A

636
00:27:30,080 --> 00:27:31,800
TASK ORDER SPECIFICALLY TO DO

637
00:27:31,800 --> 00:27:35,240
THE GMP MANUFACTURING FOR THAT.

638
00:27:35,240 --> 00:27:37,120
SO WE WILL SET UP A NEW TASK

639
00:27:37,120 --> 00:27:39,240
ORDER AND THE CONTRACT OR TASK

640
00:27:39,240 --> 00:27:43,480
ORDER IS THE AGREEMENT THAT

641
00:27:43,480 --> 00:27:46,720
ALLOWS US TO GET A THAT WORK

642
00:27:46,720 --> 00:27:47,880
DONE BY A CONTRACT RESEARCH

643
00:27:47,880 --> 00:27:49,680
ORGANIZATION THAT WE HAVE SOME

644
00:27:49,680 --> 00:27:50,760
ACADEMIC ORGANIZATIONS THAT CAN

645
00:27:50,760 --> 00:27:52,920
ALSO DO THIS FOR US.  SO ONCE WE

646
00:27:52,920 --> 00:27:54,320
HAVE AGREED TO DO THE WORK THEN

647
00:27:54,320 --> 00:27:57,160
WE WILL HAVE TELECONS THAT

648
00:27:57,160 --> 00:28:00,280
INCLUDE DMID TEAM, REQUESTER AND

649
00:28:00,280 --> 00:28:01,960
THE CRO ALL TOGETHER TALKING

650
00:28:01,960 --> 00:28:04,200
ABOUT THE NATURE OF THE WORK, WE

651
00:28:04,200 --> 00:28:09,360
GET FEEDBACK ON THE DATA. THEN

652
00:28:09,360 --> 00:28:10,440
EVENTUAL REPORT THAT COMES FROM

653
00:28:10,440 --> 00:28:12,360
THE STUDY IS SHARE WITH THE

654
00:28:12,360 --> 00:28:14,360
REQUESTER AND REPORT BECOMES THE

655
00:28:14,360 --> 00:28:16,280
PROPERTY OF THE REQUESTER, THEY

656
00:28:16,280 --> 00:28:20,480
GET TO USE THAT AS THEY SEE FIT 

657
00:28:20,480 --> 00:28:23,320
SO THAT IS OUR PROCESS. NOT

658
00:28:23,320 --> 00:28:26,760
EXACTLY -- IT CAN BE ITERATIVE,

659
00:28:26,760 --> 00:28:28,480
IT DEPENDS ON THE NATURE OF

660
00:28:28,480 --> 00:28:29,720
REQUEST WHEN IT COMES TO US. 

661
00:28:29,720 --> 00:28:31,720
MANY TIMES PEOPLE COME TO US FOR

662
00:28:31,720 --> 00:28:33,080
EXAMPLE ASKING FOR GMP

663
00:28:33,080 --> 00:28:34,000
MANUFACTURING BECAUSE THEY KNOW

664
00:28:34,000 --> 00:28:38,240
THAT'S A GAP IN THEIR PROGRAM.

665
00:28:38,240 --> 00:28:41,040
WHEN WE TALK TO THEM WE LEARN

666
00:28:41,040 --> 00:28:42,840
ABOUT THE DATA, WE MIGHT FIGURE

667
00:28:42,840 --> 00:28:44,560
OUT THERE'S SOMETHING CRITICAL

668
00:28:44,560 --> 00:28:48,200
THEY NEED BEFORE THEY GET TO GMP

669
00:28:48,200 --> 00:28:49,200
MANUFACTURING AND WE WILL

670
00:28:49,200 --> 00:28:50,480
PROVIDE THAT SERVICE INSTEAD. IT

671
00:28:50,480 --> 00:28:53,920
IS A DISCUSSION PROCESS. I'M

672
00:28:53,920 --> 00:28:58,160
GOING TO CALL OUT ON THE DMID

673
00:28:58,160 --> 00:28:59,320
TEAM, WE HAVE PRODUCT

674
00:28:59,320 --> 00:29:02,160
DEVELOPMENT SPECIALISTS, LOCATED

675
00:29:02,160 --> 00:29:03,560
IN EACH SCIENTIFIC BRANCH. SO

676
00:29:03,560 --> 00:29:05,840
THOSE ARE THE PEOPLE THAT OFTEN

677
00:29:05,840 --> 00:29:08,640
SHEPHERD REQUEST THROUGH THIS

678
00:29:08,640 --> 00:29:10,200
PROCESS. SO THEY HAVE GAIN AD

679
00:29:10,200 --> 00:29:12,320
LOT OF EXPERIENCE WITH PRODUCT

680
00:29:12,320 --> 00:29:15,680
DEVELOPMENT AS THEY PUT MORE OF

681
00:29:15,680 --> 00:29:19,880
THESE REQUESTS THROUGH THE

682
00:29:19,880 --> 00:29:21,480
PROCESS. WE FIND THIS PROCESS

683
00:29:21,480 --> 00:29:23,280
HAS BEEN GOING ON FOR PROBABLY

684
00:29:23,280 --> 00:29:26,720
OVER A DECADE WHEN WE REALLY

685
00:29:26,720 --> 00:29:29,160
EXPANDED THE ACCESS TO THESE

686
00:29:29,160 --> 00:29:32,720
RESOURCES TO ALL OF DMID COVERED

687
00:29:32,720 --> 00:29:34,920
PATHOGENS. SO A STAFF AND

688
00:29:34,920 --> 00:29:37,040
PRODUCT DEVELOPMENT SPECIALISTS

689
00:29:37,040 --> 00:29:39,160
HAVE GOTTEN USED TO THESE

690
00:29:39,160 --> 00:29:41,800
REQUESTS, THEY ARE DOING MORE

691
00:29:41,800 --> 00:29:43,720
WORK ON THE FRONT END PUT IN

692
00:29:43,720 --> 00:29:45,160
DEVELOPING GOOD REQUESTS. SO I

693
00:29:45,160 --> 00:29:47,960
JUST WANTED TO SAY THAT IN A WAY

694
00:29:47,960 --> 00:29:49,840
TO SAY THAT WE DON'T GET A LOT

695
00:29:49,840 --> 00:29:52,120
OF REQUESTS THAT COME ALL THE

696
00:29:52,120 --> 00:29:54,800
WAY TO COMMITTEE TO BE DENIED.

697
00:29:54,800 --> 00:29:57,360
THEY ARE OFTEN REFINED OR

698
00:29:57,360 --> 00:29:58,760
POTENTIALLY SENT BACK TO THE

699
00:29:58,760 --> 00:30:01,440
BRANCH FOR REFINEMENT BUT WHEN

700
00:30:01,440 --> 00:30:03,280
IT COMES TO COMMITTEE THEY ARE

701
00:30:03,280 --> 00:30:09,160
USUALLY IN GOOD SHAPE. HERE ARE

702
00:30:09,160 --> 00:30:13,320
THE CRITERIA THE PCS COMMITTEE

703
00:30:13,320 --> 00:30:15,360
DISCUSSES WHEN WE ARE LOOKING AT

704
00:30:15,360 --> 00:30:17,360
A REQUEST.  INITIALLY IS IT

705
00:30:17,360 --> 00:30:19,160
WITHIN OUR MISSION, DO WE HAVE

706
00:30:19,160 --> 00:30:22,400
THE CONTRACT SERVICES THAT CAN

707
00:30:22,400 --> 00:30:23,840
PROVIDE WHAT REQUESTER IS ASKING

708
00:30:23,840 --> 00:30:26,280
FOR, DO THEY HAVE THE PRODUCT

709
00:30:26,280 --> 00:30:29,320
AVAILABLE IN ORDER TO ACCOMPLISH

710
00:30:29,320 --> 00:30:31,680
THE PROJECT. NUMBER FOUR HERE IS

711
00:30:31,680 --> 00:30:32,920
IN COMPLIANCE WITH THE ANIMAL

712
00:30:32,920 --> 00:30:34,600
WELFARE REGULATION. SO I WILL

713
00:30:34,600 --> 00:30:37,160
JUST GIVE AN EXAMPLE OF ONE

714
00:30:37,160 --> 00:30:38,880
THING WE MIGHT LOOK AT THAT SO

715
00:30:38,880 --> 00:30:42,080
IF SOMEONE REQUESTS A NON-HUMAN

716
00:30:42,080 --> 00:30:43,960
PRIMATE STUDY, WE LOOK AT THE

717
00:30:43,960 --> 00:30:46,440
BODY OF DATA, THE SMALL ANIMAL

718
00:30:46,440 --> 00:30:48,160
DATA THAT SUPPORTS MOVING TO

719
00:30:48,160 --> 00:30:49,520
NON-HUMAN PRIMATES AND DECIDE

720
00:30:49,520 --> 00:30:50,600
WHETHER WE THINK THAT IS A

721
00:30:50,600 --> 00:30:52,640
SUFFICIENT BODY OF EVIDENCE FOR

722
00:30:52,640 --> 00:30:55,440
MOVING FORWARD OR IF THEY NEED

723
00:30:55,440 --> 00:30:58,000
MORE SMALL ANIMAL DATA. WE

724
00:30:58,000 --> 00:31:01,440
CONSIDER THE REQUEST WHETHER THE

725
00:31:01,440 --> 00:31:03,760
REQUESTER HAS OTHER SUPPORT THAT

726
00:31:03,760 --> 00:31:06,120
CAN FUND THIS PROJECT, WHETHER

727
00:31:06,120 --> 00:31:09,120
FIRST REQUEST OR REPEAT REQUEST.

728
00:31:09,120 --> 00:31:12,000
I WILL SAY MORE ABOUT THAT. 

729
00:31:12,000 --> 00:31:14,400
AGAIN WHETHER SUPPORTED BY

730
00:31:14,400 --> 00:31:15,920
ADEQUATE PRELIMINARY DATA, THEN

731
00:31:15,920 --> 00:31:18,440
WE TALK ABOUT GENERAL THINGS

732
00:31:18,440 --> 00:31:21,800
LIKE THE LIKELIHOOD OF

733
00:31:21,800 --> 00:31:23,000
CONTRIBUTING PRODUCT

734
00:31:23,000 --> 00:31:23,600
DEVELOPMENT, IN OTHER WORDS DO

735
00:31:23,600 --> 00:31:26,240
THEY HAVE A PLAN TO CARRY THIS

736
00:31:26,240 --> 00:31:27,840
PRODUCT FORWARDS? IS THIS

737
00:31:27,840 --> 00:31:29,960
PRODUCT IMPACTFUL TO PUBLIC

738
00:31:29,960 --> 00:31:31,560
HEALTH? IS IT GOING TO IMPROVE

739
00:31:31,560 --> 00:31:35,360
UPON EXISTING PRODUCTS. IS IT A

740
00:31:35,360 --> 00:31:37,760
HIGH PRIORITY FOR NIAID.  SO

741
00:31:37,760 --> 00:31:40,120
THOSE ARE THINGS WE DISCUSS WHEN

742
00:31:40,120 --> 00:31:45,280
TALKING ABOUT THE REQUEST. SO WE

743
00:31:45,280 --> 00:31:46,960
DO OUR BEST TO MAKE SURE THAT

744
00:31:46,960 --> 00:31:49,400
EVERYONE IS AWARE OF THESE

745
00:31:49,400 --> 00:31:53,680
PRE-CLINICAL SERVICES, SO AS I

746
00:31:53,680 --> 00:31:54,960
MENTIONED EARLIER PEOPLE'S

747
00:31:54,960 --> 00:31:57,360
PROGRAM OFFICER IS OFTEN THEIR

748
00:31:57,360 --> 00:32:02,840
FIRST STOP. WE ALSO DO HAVE ALL

749
00:32:02,840 --> 00:32:05,440
THESE MAILBOXES SO YOU CAN

750
00:32:05,440 --> 00:32:07,320
CONTACT STAFF AND IF SOMEONE IS

751
00:32:07,320 --> 00:32:09,000
OUT SOMEONE ELSE WILL ANSWER THE

752
00:32:09,000 --> 00:32:10,360
MAIL. WE HAVE ONE OF THOSE FOR

753
00:32:10,360 --> 00:32:16,840
EACH OF THE SERVICES. WE ALSO

754
00:32:16,840 --> 00:32:19,280
HAVE A RESEARCHER RESOURCES FOR

755
00:32:19,280 --> 00:32:22,520
RESEARCHERS WEB PAGE FOR NIAID.

756
00:32:22,520 --> 00:32:24,120
FOR NIAID AT LARGE THERE ARE

757
00:32:24,120 --> 00:32:27,200
MANY, MANY RESOURCES THERE,

758
00:32:27,200 --> 00:32:29,240
SUGGEST AS YOU FILTER ON

759
00:32:29,240 --> 00:32:30,760
PRE-CLINICAL SERVICES AND DMID

760
00:32:30,760 --> 00:32:32,360
YOU WILL COME UP WITH THESE FIVE

761
00:32:32,360 --> 00:32:35,880
SERVICES THAT ARE LISTED HERE. 

762
00:32:35,880 --> 00:32:37,520
SO THERAPEUTIC AND VACCINE

763
00:32:37,520 --> 00:32:38,680
DEVELOPMENT SERVICES ARE WHAT

764
00:32:38,680 --> 00:32:41,160
YOU ARE GOING TO HEAR ABOUT

765
00:32:41,160 --> 00:32:45,240
LATER TODAY.  STAFF ARE

766
00:32:45,240 --> 00:32:47,000
CONSTANTLY PRESENTING ABOUT

767
00:32:47,000 --> 00:32:48,840
THESE PRE-CLINICAL SERVICES AS

768
00:32:48,840 --> 00:32:51,160
THEY ARE GOING TO CONFERENCES,

769
00:32:51,160 --> 00:32:53,600
AND WORKSHOPS, EITHER ORAL

770
00:32:53,600 --> 00:32:55,960
PRESENTATIONS OR POSTERS, AND

771
00:32:55,960 --> 00:32:58,800
THIS IS JUST AN EXAMPLE. WE HAVE

772
00:32:58,800 --> 00:33:01,200
A BROCHURE, THIS IS FOR

773
00:33:01,200 --> 00:33:02,480
ANTIVIRAL PROGRAM FOR PANDEMICS.

774
00:33:02,480 --> 00:33:04,320
WE DEVELOPED A BROCHURE THAT

775
00:33:04,320 --> 00:33:06,000
GETS TO A LITTLE BIT MORE DETAIL

776
00:33:06,000 --> 00:33:08,240
ABOUT THE ACTUAL SERVICES THAT

777
00:33:08,240 --> 00:33:11,240
WE ALREADY HAVE UNDER CONTRACTS.

778
00:33:11,240 --> 00:33:15,040
THAT IS JUST A LITTLE SNAP SHOT

779
00:33:15,040 --> 00:33:17,440
OF THAT. THAT IS THE END OF MY

780
00:33:17,440 --> 00:33:19,560
PRESENTATION I WILL MAKE ONE

781
00:33:19,560 --> 00:33:24,520
LAST COMMENT. WE WORK WITH OTHER

782
00:33:24,520 --> 00:33:31,720
PARTNERS FOR EXAMPLE CARBAX OR

783
00:33:31,720 --> 00:33:33,000
SEPE, WE CAN'T GIVE THEM OUR

784
00:33:33,000 --> 00:33:36,600
FUNDS FOR THEM TO SPEND ON THEIR

785
00:33:36,600 --> 00:33:37,880
PROGRAMS, BUT WE USE OUR

786
00:33:37,880 --> 00:33:39,240
PRE-CLINICAL SERVICES THE ONCE

787
00:33:39,240 --> 00:33:40,960
AGAIN PROVIDE IN KIND RESOURCES

788
00:33:40,960 --> 00:33:46,040
TO INVESTIGATORS THAT CARVAX AND

789
00:33:46,040 --> 00:33:47,640
SEPE AND OTHER STAKEHOLDERS ARE

790
00:33:47,640 --> 00:33:50,160
FUNDING. SO WITH THAT I WILL

791
00:33:50,160 --> 00:34:00,720
CLOSE AND TAKE ANY QUESTIONS.  

792
00:34:13,800 --> 00:34:15,240
WE CAN MAKE SURE OF THAT,

793
00:34:15,240 --> 00:34:17,480
PROBABLY NOT THIS EXACT SLIDE

794
00:34:17,480 --> 00:34:22,080
SET BUT WE DO HAVE A MORE

795
00:34:22,080 --> 00:34:23,080
COMPREHENSIVE SET OF SLIDES WE

796
00:34:23,080 --> 00:34:27,200
HAVE PREPARED FOR STAFF TO PICK

797
00:34:27,200 --> 00:34:28,320
AND CHOOSE FROM GOING FROM

798
00:34:28,320 --> 00:34:29,800
VARIOUS MEETINGS. SOME OF THESE

799
00:34:29,800 --> 00:34:33,720
SLIDES YOU SAW TODAY WERE NEWER

800
00:34:33,720 --> 00:34:35,160
REFUNDS SO WE WILL MAKE SURE

801
00:34:35,160 --> 00:34:45,520
THEY ARE AVAILABLE.

802
00:34:56,040 --> 00:35:06,160
(OFF MIC)

803
00:35:51,080 --> 00:35:53,840
>>GOOD AFTERNOON. TODAY I
WILL

804
00:35:53,840 --> 00:35:56,480
TALK ABOUT TWO CONCEPTS FOR

805
00:35:56,480 --> 00:35:58,160
APPROVAL, THE INTERVENTIONAL

806
00:35:58,160 --> 00:36:00,280
AGENTS FOR SAFETY AND

807
00:36:00,280 --> 00:36:01,760
PHARMACOKINETICS SERVICES AND

808
00:36:01,760 --> 00:36:02,720
INTERVENTIONAL AGENTS FOR

809
00:36:02,720 --> 00:36:05,440
CHEMISTRY SERVICES. THE

810
00:36:05,440 --> 00:36:07,480
OBJECTIVE OF THESE SERVICES ARE

811
00:36:07,480 --> 00:36:09,280
TO PROVIDE DIVERSE SUITE OF

812
00:36:09,280 --> 00:36:11,120
SERVICES TO SUPPORT

813
00:36:11,120 --> 00:36:12,160
THERAPEUTICS, PRODUCT

814
00:36:12,160 --> 00:36:14,800
DEVELOPMENT FROM EARLY LEAD

815
00:36:14,800 --> 00:36:16,920
OPTIMIZATION TO ENABLING

816
00:36:16,920 --> 00:36:18,000
STUDIES.  THANK YOU, DR. HEWITT

817
00:36:18,000 --> 00:36:20,560
FOR GIVING ME A GREAT OVERVIEW

818
00:36:20,560 --> 00:36:22,040
BECAUSE IT SAVED ME QUITE A BIT

819
00:36:22,040 --> 00:36:25,640
OF TIME. THE SAFETY AND

820
00:36:25,640 --> 00:36:27,000
PHARMACOKINETIC SERVICES INCLUDE

821
00:36:27,000 --> 00:36:28,880
PRODUCT DEVELOPMENT PLANNING IN

822
00:36:28,880 --> 00:36:31,440
VITRO ABSORPTION, DISTRIBUTION,

823
00:36:31,440 --> 00:36:33,920
METABOLISM, EXCRETION,

824
00:36:33,920 --> 00:36:36,640
TOXICOLOGY. IN VITRO

825
00:36:36,640 --> 00:36:38,320
PHARMACOKINETICS OR PK SAFETY

826
00:36:38,320 --> 00:36:39,720
AND TOXICOLOGY. THE CHEMISTRY

827
00:36:39,720 --> 00:36:41,840
SERVICES ARE GOING TO INCLUDE

828
00:36:41,840 --> 00:36:43,200
MEDICINAL CHEMISTRY SYNTHESIS

829
00:36:43,200 --> 00:36:45,960
PROCESS CHEMISTRY OPTIMIZATION,

830
00:36:45,960 --> 00:36:48,360
PREPARATION TOXICOLOGY BATCHES,

831
00:36:48,360 --> 00:36:50,360
GMP MANUFACTURING AS WELL AS

832
00:36:50,360 --> 00:36:53,240
DRUG SUBSTANCE AND DRUG PRODUCT

833
00:36:53,240 --> 00:36:55,560
RELEASE AND STABILITY TESTING.  

834
00:36:55,560 --> 00:36:59,160
THIS IS A NEW CONCEPT, THESE TWO

835
00:36:59,160 --> 00:37:01,200
NEW CONCEPTS WILL FOLLOW A SEVEN

836
00:37:01,200 --> 00:37:03,440
YEAR IDIQ AND THE ANTICIPATED

837
00:37:03,440 --> 00:37:05,080
NUMBER OF AWARDS FOR THE

838
00:37:05,080 --> 00:37:06,040
CHEMISTRY SERVICE IS

839
00:37:06,040 --> 00:37:07,120
APPROXIMATELY SIX AND FOR THE

840
00:37:07,120 --> 00:37:09,920
SAFETY AND PHARMACOKINETIC

841
00:37:09,920 --> 00:37:15,680
SERVICES APPROXIMATELY 12. SO

842
00:37:15,680 --> 00:37:17,440
GRAPHICS SHOWING MANY WAYS BUT

843
00:37:17,440 --> 00:37:21,360
DRUG DEVELOPMENT IN GENERAL VERY

844
00:37:21,360 --> 00:37:22,000
COMPLEX LENGTHY RISKY COSTLY, ET

845
00:37:22,000 --> 00:37:26,040
CETERA.  WE SEE ATTRITION IN THE

846
00:37:26,040 --> 00:37:27,280
EARLY PARTS OF THE PATHWAY IN

847
00:37:27,280 --> 00:37:28,840
THE VALLEY OF DEATH. SO WE

848
00:37:28,840 --> 00:37:31,640
REALLY NEED TO FIND GOOD WAYS TO

849
00:37:31,640 --> 00:37:38,240
MITIGATE THIS RISK BY PROCURING

850
00:37:38,240 --> 00:37:40,240
PROJECTS EARLY. THIS DIAGRAM

851
00:37:40,240 --> 00:37:43,320
SHOWS OVERALL DRUG DEVELOPMENT

852
00:37:43,320 --> 00:37:46,480
FOR THERAPEUTIC AREAS IN THE

853
00:37:46,480 --> 00:37:48,080
ANTI-INFECTED SPACE YAHOO SEE

854
00:37:48,080 --> 00:37:49,640
HIGH ATTRITION RATE IN THE

855
00:37:49,640 --> 00:37:51,640
VALLEY OF DEATH SO TO SPEAK.

856
00:37:51,640 --> 00:37:52,960
THIS THEN CAUSES LATER PRODUCTS

857
00:37:52,960 --> 00:37:55,480
TO HAVE HIGHER CHANCE OF SUCCESS

858
00:37:55,480 --> 00:37:57,120
BECAUSE CLINICAL MODEL OR

859
00:37:57,120 --> 00:37:58,120
PRE-CLINICAL MODELS ARE CLOSELY

860
00:37:58,120 --> 00:37:59,440
RELATED TO WHAT WE SEE IN THE

861
00:37:59,440 --> 00:38:02,120
CLINIC. SO THERE IS AN EVEN

862
00:38:02,120 --> 00:38:03,600
BIGGER NEED FOR PRE-CLINICAL

863
00:38:03,600 --> 00:38:08,880
SERVICES FOR ANTI-INFECTIVES.  

864
00:38:08,880 --> 00:38:10,240
SO THIS SLIDE ILLUSTRATES WHERE

865
00:38:10,240 --> 00:38:12,800
DIFFERENT PARTS OF DMID FOCUS

866
00:38:12,800 --> 00:38:15,360
OVERLAP WITH THE PRODUCT

867
00:38:15,360 --> 00:38:16,800
DEVELOPMENT PATHWAY. THE

868
00:38:16,800 --> 00:38:18,240
PRE-CLINICAL SERVICES ARE USED

869
00:38:18,240 --> 00:38:20,960
FOR AS YOU HEARD E TERM

870
00:38:20,960 --> 00:38:21,840
ORGANIZATIONS BUT ALSO INTERNAL,

871
00:38:21,840 --> 00:38:25,080
THEY HAVE BEEN USED TO SUPPORT

872
00:38:25,080 --> 00:38:27,960
GRANTS, PRODUCT DEVELOPMENT

873
00:38:27,960 --> 00:38:29,160
CONTRACTS PHASE 1 CLINICAL

874
00:38:29,160 --> 00:38:30,760
SERVICES SO FOR TODAY WE WILL

875
00:38:30,760 --> 00:38:33,640
TALK ABOUT THE BOX IN GREEN,

876
00:38:33,640 --> 00:38:37,360
PRE-CLINICAL SERVICES. AS YOU

877
00:38:37,360 --> 00:38:39,040
HEARD DR. HEWITT SAY, WE SHARE

878
00:38:39,040 --> 00:38:41,000
OUR SUBJECT MATTER EXPERTISE AND

879
00:38:41,000 --> 00:38:43,200
SUPPORT EXTERNAL REQUESTERS WITH

880
00:38:43,200 --> 00:38:45,680
THESE GAP FILLING PRE-CLINICAL

881
00:38:45,680 --> 00:38:48,120
SERVICES TO DERISK THERAPEUTIC. 

882
00:38:48,120 --> 00:38:49,360
THESE ARE IN THIS CASE SMALL

883
00:38:49,360 --> 00:38:52,200
MOLECULES NATURAL PRODUCTS SMALL

884
00:38:52,200 --> 00:38:54,320
PEPTIDES, OTHER ITEMS FALL UNDER

885
00:38:54,320 --> 00:38:55,520
THE OH PRE-CLINICAL SERVICES

886
00:38:55,520 --> 00:38:57,000
THAT WE OFFER TO SUPPORT

887
00:38:57,000 --> 00:39:00,560
PROGRAMS.  THESE ARE ALL USED TO

888
00:39:00,560 --> 00:39:02,560
SUPPORT PROJECTS THAT ARE

889
00:39:02,560 --> 00:39:05,200
TARGETING NIAID PATHOGENS OF

890
00:39:05,200 --> 00:39:06,480
INTEREST. THE TAKE AWAY FROM

891
00:39:06,480 --> 00:39:08,680
THIS SLIDE I WILL REFER TO LATER

892
00:39:08,680 --> 00:39:10,680
IS FIVE DIFFERENT TASK AREAS IN

893
00:39:10,680 --> 00:39:13,480
THE CURRENT PRE-CLINICAL

894
00:39:13,480 --> 00:39:15,760
SERVICES. TASK AREAS A THROUGH

895
00:39:15,760 --> 00:39:17,000
E, A IS PRODUCT DEVELOPMENT

896
00:39:17,000 --> 00:39:18,560
PLANNING, PROVIDING PRODUCT

897
00:39:18,560 --> 00:39:19,720
DEVELOPMENT PLAN FOR REQUESTER

898
00:39:19,720 --> 00:39:21,840
AND HOW TO GET COMPOUND INTO THE

899
00:39:21,840 --> 00:39:25,160
CLINIC. TASK AREA B IS DISCOVERY

900
00:39:25,160 --> 00:39:28,200
SIDE OF SYNTHESIS SO MEDICINAL

901
00:39:28,200 --> 00:39:30,240
CHEMISTRY SYNTHESIS OF BULK

902
00:39:30,240 --> 00:39:32,000
INTERMEDIATES, TARGETS WE MAY

903
00:39:32,000 --> 00:39:34,440
NEED TO ASSESS STRUCTURAL

904
00:39:34,440 --> 00:39:36,320
ACTIVITY, RELATIONSHIPS TASK

905
00:39:36,320 --> 00:39:39,920
AREA C IS LATER. IN THE PATHWAY,

906
00:39:39,920 --> 00:39:42,080
NOW OPTIMIZING CHEMICAL

907
00:39:42,080 --> 00:39:47,560
SYNTHESIS, DOING BULK -- DRUG

908
00:39:47,560 --> 00:39:50,160
PRODUCT AND NON-GMP AND GMP

909
00:39:50,160 --> 00:39:52,000
MANUFACTURING. TASK AREA D IS

910
00:39:52,000 --> 00:39:53,720
PRE-CLINICAL SAFETY AND

911
00:39:53,720 --> 00:39:55,960
TOXICOLOGY FOR THE MORE

912
00:39:55,960 --> 00:39:58,320
COMPLICATED PHARMACOKINETIC

913
00:39:58,320 --> 00:40:01,720
SERVICES, THIS INCLUDES GLP AND

914
00:40:01,720 --> 00:40:05,320
NON-GLP TESTING. IN TASK AREA E

915
00:40:05,320 --> 00:40:07,280
WE HAVE LEAD OPTIMIZATION FOR

916
00:40:07,280 --> 00:40:09,240
ADME SAFETY AND RAPID PK, THIS

917
00:40:09,240 --> 00:40:11,600
IS EARLIER ON FOR LEAD

918
00:40:11,600 --> 00:40:13,720
OPTIMIZATION, THIS IS RAPID HELP

919
00:40:13,720 --> 00:40:15,640
DEVELOP LEAD OFF PROGRAM TO MOVE

920
00:40:15,640 --> 00:40:23,440
FURTHER IN THE PATHWAY. SO LET'S

921
00:40:23,440 --> 00:40:24,880
LOOK AT KEY ACCOMPLISHMENT OUR

922
00:40:24,880 --> 00:40:26,000
CURRENT ITERATION OF THE

923
00:40:26,000 --> 00:40:29,680
PRE-CLINICAL SERVICES. WE HAVE

924
00:40:29,680 --> 00:40:31,000
CONTRIBUTED TO EIGHT MARKETED

925
00:40:31,000 --> 00:40:32,880
DRUGS. SOME OF THESE FDA

926
00:40:32,880 --> 00:40:35,880
APPROVALS WERE PROJECTS DRIVEN

927
00:40:35,880 --> 00:40:38,480
BY PUBLIC PRIVATE PARTNERSHIPS

928
00:40:38,480 --> 00:40:42,120
OR ADVANCE NIH HHS OBJECTIVES.

929
00:40:42,120 --> 00:40:43,880
OF THESE EIGHT MARKETED DRUGS,

930
00:40:43,880 --> 00:40:46,120
THREE MARKETED DRUGS RECEIVED

931
00:40:46,120 --> 00:40:48,000
INITIAL APPROVAL LISTED HERE AND

932
00:40:48,000 --> 00:40:50,160
THE OTHERS, FIVE OTHERS RECEIVED

933
00:40:50,160 --> 00:40:51,920
APPROVAL FOR NEW INDICATION

934
00:40:51,920 --> 00:40:55,800
USING PCS. AN EXAMPLE HOW WE USE

935
00:40:55,800 --> 00:40:59,240
SERVICES TO OVERLAP WITH OTHER

936
00:40:59,240 --> 00:41:00,640
PROGRAMS FOR INSTANCE THE DRUG

937
00:41:00,640 --> 00:41:02,240
DEVELOPMENT SECTION PRODUCT

938
00:41:02,240 --> 00:41:03,640
DEVELOPMENT PORTFOLIO 75%

939
00:41:03,640 --> 00:41:06,000
CURRENT PROJECTS RECEIVED PCS

940
00:41:06,000 --> 00:41:07,120
SUPPORT AT SOME POINT PRIOR TO

941
00:41:07,120 --> 00:41:10,800
AWARD. WE CAN USE SERVICES FOR

942
00:41:10,800 --> 00:41:13,880
FOLKS TO COME THROUGH THE VAA

943
00:41:13,880 --> 00:41:16,360
THAT HAVE PROGRAMS INTERESTING

944
00:41:16,360 --> 00:41:18,480
TO OUR NEEDS. WE CAN PROVIDE

945
00:41:18,480 --> 00:41:19,760
THEM PRE-CLINICAL SERVICES TO

946
00:41:19,760 --> 00:41:21,840
PREPARE FOR NEXT YEAR'S VA SO

947
00:41:21,840 --> 00:41:26,760
THEY ARE READY FOR A BETTER

948
00:41:26,760 --> 00:41:28,120
PROPOSAL AND ULTIMATELY WE HAVE

949
00:41:28,120 --> 00:41:29,240
SEEN THIS HAPPEN MANY TIME WHERE

950
00:41:29,240 --> 00:41:33,880
IS SERVICES WERE KEY GAPS IN

951
00:41:33,880 --> 00:41:35,120
THEIR PROPOSAL AND THEY ALL

952
00:41:35,120 --> 00:41:36,280
RECEIVED FUNDING THE FOLLOWING

953
00:41:36,280 --> 00:41:37,640
YEAR SO WE CAN SUPPORT OUR NEEDS

954
00:41:37,640 --> 00:41:39,160
USING THE PRE-CLINICAL SERVICES

955
00:41:39,160 --> 00:41:44,120
TO GET THINGS INTO PRODUCT

956
00:41:44,120 --> 00:41:45,280
DEVELOPMENT. SO LET'S TALK THE

957
00:41:45,280 --> 00:41:48,360
SCOPE OF OUR SUPPORT. SO

958
00:41:48,360 --> 00:41:50,360
ORIGINALLY, BACK IN 2006 WE

959
00:41:50,360 --> 00:41:51,600
AWARDED ALL THESE FIVE DIFFERENT

960
00:41:51,600 --> 00:41:54,800
AREAS TO A SINGLE CONTRACTOR. SO

961
00:41:54,800 --> 00:41:57,600
THAT CONTRACTOR NEEDED TO

962
00:41:57,600 --> 00:41:59,720
PROVIDE THAT WHOLE LIST OF

963
00:41:59,720 --> 00:42:01,040
SERVICES, THEY DID A GOOD JOB

964
00:42:01,040 --> 00:42:02,120
BUT AS WITH E MOVE FORWARD WE

965
00:42:02,120 --> 00:42:03,640
WANT TO INCREASE THE COMPETITION

966
00:42:03,640 --> 00:42:06,040
AND THE DIVERSITY OF OUR

967
00:42:06,040 --> 00:42:07,800
CAPABILITIES SO IN 2018 WE SPLIT

968
00:42:07,800 --> 00:42:11,240
OUT EACH OF THOSE TASK AREAS

969
00:42:11,240 --> 00:42:13,120
INTO THEIR OWN TARGET IF YOU

970
00:42:13,120 --> 00:42:14,920
WILL WHERE WE WERE THEN GOING TO

971
00:42:14,920 --> 00:42:16,360
POPULATE THAT POOL WITH

972
00:42:16,360 --> 00:42:17,560
CONTRACTORS FOR ONLY THAT

973
00:42:17,560 --> 00:42:22,000
SPECIFIC TASK AREA. WHAT YOU CAN

974
00:42:22,000 --> 00:42:23,720
SEE IS WE LEARN AD FEW THINGS,

975
00:42:23,720 --> 00:42:25,360
TASK AREA B AND C ARE NOW

976
00:42:25,360 --> 00:42:27,640
HIGHLIGHTED IN RED. THIS IS THE

977
00:42:27,640 --> 00:42:29,600
CHEMISTRY TASK ORDER, CHEMISTRY

978
00:42:29,600 --> 00:42:30,800
AND MANUFACTURING, WE WERE

979
00:42:30,800 --> 00:42:31,840
SIGNIFICANTLY LIMITED BY THE

980
00:42:31,840 --> 00:42:34,640
NUMBER OF CONTRACTORS THAT CAME

981
00:42:34,640 --> 00:42:37,440
IN THROUGH THAT MECHANISM.

982
00:42:37,440 --> 00:42:38,920
SPECULATE LATER WHY THIS MAY

983
00:42:38,920 --> 00:42:42,080
HAVE BEEN, WE NEED TO NOTE THERE

984
00:42:42,080 --> 00:42:44,160
THERE WAS LIMITATIONS THERE, THE

985
00:42:44,160 --> 00:42:46,560
SAFETY AND PK, A LOT OF THESE

986
00:42:46,560 --> 00:42:49,080
SAFETY GLP TALKS, THESE ARE BIG

987
00:42:49,080 --> 00:42:51,960
STUDIES, COSTLY STUDIES YOU WANT

988
00:42:51,960 --> 00:42:53,160
A LARGE POOL TO MAXIMIZE

989
00:42:53,160 --> 00:42:54,120
COMPETITION AND MAXIMIZE THE

990
00:42:54,120 --> 00:42:57,080
CAPABILITIES. AS THIS PROGRAM

991
00:42:57,080 --> 00:42:59,400
MOVE FORWARD NUMBER OF COMPANIES

992
00:42:59,400 --> 00:43:02,120
CHANGE THEIR BUSINESS MODEL OR

993
00:43:02,120 --> 00:43:04,520
THEY LOST KEY PLAYERS AND MAYBE

994
00:43:04,520 --> 00:43:05,640
NO LONGER CONSIDERED EXPERTS IN

995
00:43:05,640 --> 00:43:09,440
THE AREA. BECAUSE OF THAT OUR

996
00:43:09,440 --> 00:43:10,960
POOLS WERE REDUCED TO TWO SO

997
00:43:10,960 --> 00:43:12,400
LIMITD BY THE CAPABILITIES WE

998
00:43:12,400 --> 00:43:14,480
CAN OFFER BUT NOT LIMITED TO THE

999
00:43:14,480 --> 00:43:16,680
POINT THAT IT WAS DEBILITATING

1000
00:43:16,680 --> 00:43:17,480
BUT WOULD HAVE BEEN NICE TO HAVE

1001
00:43:17,480 --> 00:43:20,040
MORE. ENOUGH THE FINAL SPACE WE

1002
00:43:20,040 --> 00:43:23,240
SAW THAT RAPID ADME AND

1003
00:43:23,240 --> 00:43:24,800
PROFILING PK FOR LEAD OFF, THIS

1004
00:43:24,800 --> 00:43:27,520
IS A HEAVILY USED RESOURCE

1005
00:43:27,520 --> 00:43:28,840
BECAUSE EARLY LEAD OFF YOU

1006
00:43:28,840 --> 00:43:30,480
TYPICALLY HAVE A HARD TIME

1007
00:43:30,480 --> 00:43:32,760
FINDING CHEMISTRY BUT YOU CAN DO

1008
00:43:32,760 --> 00:43:35,640
A LITTLE SAR BY CATALOG IF YOU

1009
00:43:35,640 --> 00:43:38,320
WILL OR ANALOG BY CATALOG. BUY

1010
00:43:38,320 --> 00:43:40,360
IN CERTAIN SUBSTRATES TO DEVELOP

1011
00:43:40,360 --> 00:43:41,040
STRUCTURAL ACTIVITY

1012
00:43:41,040 --> 00:43:42,320
RELATIONSHIPS BUT THEY STILL

1013
00:43:42,320 --> 00:43:44,320
WILL NOT HAVE A WAY TO GET

1014
00:43:44,320 --> 00:43:45,720
PHARMACOKINETICS AND SEE IF IT

1015
00:43:45,720 --> 00:43:50,040
WORKS AS POTENTIAL TREATMENT INN

1016
00:43:50,040 --> 00:43:52,120
VIVO. ONE ORIGINAL CONTRACTORS

1017
00:43:52,120 --> 00:43:53,520
WAS A SPECIALIST. THIS IS ALL

1018
00:43:53,520 --> 00:43:55,720
THEY DID SO THEY AWARDED THE

1019
00:43:55,720 --> 00:43:57,920
EARLY CONTRACTS THAT WERE

1020
00:43:57,920 --> 00:43:59,200
AWARDED WENT ALL TO THEM. THEY

1021
00:43:59,200 --> 00:44:01,440
ARE CHEAPER AND PRICED EVERYBODY

1022
00:44:01,440 --> 00:44:02,800
ELSE ON THE MARKET. BECAUSE OF

1023
00:44:02,800 --> 00:44:05,880
THAT WE NO LONGER RECEIVE BID

1024
00:44:05,880 --> 00:44:07,880
ANYONE ELSE. THEY CAN PROVIDE

1025
00:44:07,880 --> 00:44:08,760
CAPABILITIES, ONLY ONE PERSON IN

1026
00:44:08,760 --> 00:44:16,040
THE POOL. SO LET'S LOOK AT THE

1027
00:44:16,040 --> 00:44:17,080
SCOPE OF SUPPORT WHAT WE WANT

1028
00:44:17,080 --> 00:44:21,080
GOING FORWARD.  SO WE WILL RENEW

1029
00:44:21,080 --> 00:44:23,440
WITH THE SAME SCOPE. WE NEED TO

1030
00:44:23,440 --> 00:44:26,680
SEPARATE THE CHEMISTRY FROM THE

1031
00:44:26,680 --> 00:44:29,120
SAFETY AND PK WITH THE SAME

1032
00:44:29,120 --> 00:44:30,560
RATIONALE AS BEFORE TO CREATE

1033
00:44:30,560 --> 00:44:32,280
DEEPER AND MORE COMPETITIVE TASK

1034
00:44:32,280 --> 00:44:36,440
AREAS. LET'S LOOK FIRST OFF WITH

1035
00:44:36,440 --> 00:44:41,000
THE SAFETY AND PHARM PHARMACOKIC

1036
00:44:41,000 --> 00:44:42,720
SERVICES SO WE STILL PROVIDE

1037
00:44:42,720 --> 00:44:44,960
PRODUCT AND PLANNING BUT TAKE

1038
00:44:44,960 --> 00:44:49,800
TASK AREA D, GLP AND NON-GLP

1039
00:44:49,800 --> 00:44:50,840
TESTING WHICH LIMIT WHAT

1040
00:44:50,840 --> 00:44:52,240
COMPANIES CAN BUY BECAUSE IT IS

1041
00:44:52,240 --> 00:44:53,680
NOT VERY COMMON SO WE TAKE THAT

1042
00:44:53,680 --> 00:44:56,960
TASK AREA, SPLIT IT OUT TO

1043
00:44:56,960 --> 00:44:59,320
NON-GLP IN VITRO TESTING NON-GLP

1044
00:44:59,320 --> 00:45:01,840
IN I HAVE SLOW TESTING. THIS

1045
00:45:01,840 --> 00:45:04,240
OPENS UP THE POOL POTENTIAL

1046
00:45:04,240 --> 00:45:06,240
BIDDERS SIGNIFICANTLY. SO SOME

1047
00:45:06,240 --> 00:45:09,080
FOLKS THEY COME IN JUST IN VITRO

1048
00:45:09,080 --> 00:45:11,080
GLP TESTING SO OVERALL WE SEE A

1049
00:45:11,080 --> 00:45:12,480
HUGE INCREASE IN COMPETITION AND

1050
00:45:12,480 --> 00:45:14,480
CAPABILITIES AND WE WILL KEEP

1051
00:45:14,480 --> 00:45:17,680
GLP IN VITRO AND IN VIVO TESTING

1052
00:45:17,680 --> 00:45:20,600
IN ITS OWN TASK AREA. AS WE GO

1053
00:45:20,600 --> 00:45:24,400
DOWN THE TWO TASK AREA E WE GET

1054
00:45:24,400 --> 00:45:27,160
QUICK IN VITRO ADME AND PK

1055
00:45:27,160 --> 00:45:29,440
PROVILING, NOW WE HOPE WE CAN

1056
00:45:29,440 --> 00:45:31,600
ATTRACT MORE COMPANIES THAT CAN

1057
00:45:31,600 --> 00:45:34,320
DO FIXED FEE FOR US. THIS WILL

1058
00:45:34,320 --> 00:45:35,680
SIGNIFICANTLY REDUCE THE COST,

1059
00:45:35,680 --> 00:45:37,280
BUT ALSO INCREASE CAPACITY

1060
00:45:37,280 --> 00:45:39,200
BECAUSE THEY ARE OFF THE SHELF

1061
00:45:39,200 --> 00:45:40,760
PRODUCTS WE CAN REQUEST QUICKER

1062
00:45:40,760 --> 00:45:44,400
THAN WE CURRENTLY DO. MOVING

1063
00:45:44,400 --> 00:45:46,600
FORWARD TO CHEMISTRY SERVICES,

1064
00:45:46,600 --> 00:45:50,440
WE ARE GOING TO DIVIDE CHEMISTRY

1065
00:45:50,440 --> 00:45:52,360
SERVICES INTO SUBSECTIONS WHERE

1066
00:45:52,360 --> 00:45:55,280
WE WILL PUT OUT FIVE

1067
00:45:55,280 --> 00:45:56,360
SUBCATEGORIES OF THINGS THAT WE

1068
00:45:56,360 --> 00:45:59,040
ARE INTERESTED IN, AND ALLOW

1069
00:45:59,040 --> 00:46:02,040
FOLKS TO APPLY FOR SUBCATEGORIES

1070
00:46:02,040 --> 00:46:03,840
AND AS LONG AS THEY COVER THE

1071
00:46:03,840 --> 00:46:06,200
MAJORITY THREE, THAT WE KNOW

1072
00:46:06,200 --> 00:46:07,880
COULD AWARD CONTRACTS TO THOSE

1073
00:46:07,880 --> 00:46:10,280
THREE. THIS GIVES US THE

1074
00:46:10,280 --> 00:46:12,120
CAPABILITY OF TARGETING MORE

1075
00:46:12,120 --> 00:46:13,800
SPECIALIZED CHEMICAL SYNTHESIS

1076
00:46:13,800 --> 00:46:16,600
BUT ALSO GIVING THE CAPABILITY

1077
00:46:16,600 --> 00:46:20,800
TO MORE THAN TWO OR THREE LARGE

1078
00:46:20,800 --> 00:46:23,200
CROs TO APPLY TO THIS. I'M A

1079
00:46:23,200 --> 00:46:24,760
MEDICINAL CHEMIST, I HAVE BEEN

1080
00:46:24,760 --> 00:46:26,880
MY WHOLE CAREER AND THE TWO

1081
00:46:26,880 --> 00:46:28,240
FOLKS IN THE POOL NEVER WORKED

1082
00:46:28,240 --> 00:46:29,840
WITH BEFORE SO THERE IS A LOT OF

1083
00:46:29,840 --> 00:46:31,960
FOLKS OUT THERE I KNOW COULD DO

1084
00:46:31,960 --> 00:46:33,400
GOOD SYNTHESIS, WE DIDN'T HAVE

1085
00:46:33,400 --> 00:46:34,800
THAT CAPABILITY BECAUSE THEY

1086
00:46:34,800 --> 00:46:37,200
HAVE NO BIOLOGY AT ALL, ALL JUST

1087
00:46:37,200 --> 00:46:38,480
CHEMISTRY.  THIS IS GREAT

1088
00:46:38,480 --> 00:46:39,440
OPPORTUNITY TO EXPAND THAT

1089
00:46:39,440 --> 00:46:41,920
SCOPE. ONE FINAL POINT TO MAKE

1090
00:46:41,920 --> 00:46:43,680
ON THIS SLIDE.  WE HAVE ALWAYS

1091
00:46:43,680 --> 00:46:45,440
WORKED WITH OUR OFFICE OF

1092
00:46:45,440 --> 00:46:47,280
SITUATION FOLKS BECAUSE THEY

1093
00:46:47,280 --> 00:46:49,400
HELP US EXPAND WHAT WE DO. THEY

1094
00:46:49,400 --> 00:46:51,760
CAME UP WITH A MECHANISM CALLED

1095
00:46:51,760 --> 00:46:53,240
ONRAMPING THAT WE ARE GOING TO

1096
00:46:53,240 --> 00:46:57,600
TRY WITH THIS NEW INITIATIVES

1097
00:46:57,600 --> 00:46:59,920
WHERE WE CAN BRING NEW

1098
00:46:59,920 --> 00:47:01,760
CONTRACTORS THAT PROVIDE NEW

1099
00:47:01,760 --> 00:47:04,080
CAPABILITIES OR BRING IN NEW

1100
00:47:04,080 --> 00:47:05,400
CONTRACTORS TO REPLACE FOLKS

1101
00:47:05,400 --> 00:47:07,280
THAT LEAVE SO THAT WE HAVE THE

1102
00:47:07,280 --> 00:47:09,000
CAPACITY AT ALL TIMES MAXIMIZE

1103
00:47:09,000 --> 00:47:12,080
AS WELL AS THE COMPETITION.

1104
00:47:12,080 --> 00:47:13,720
GREAT IDEA LOOKING FORWARD HOW

1105
00:47:13,720 --> 00:47:15,960
THAT CAN HELP AND WHEN WE HAVE A

1106
00:47:15,960 --> 00:47:17,920
CYCLE REFRESH THE CONTRACTOR

1107
00:47:17,920 --> 00:47:20,160
POOLS REALLY JUST A SPECTACULAR

1108
00:47:20,160 --> 00:47:28,720
IDEA.  SO I HAVE MET WITH

1109
00:47:28,720 --> 00:47:31,000
DOCTORS BOCKENSTEDT AND STEWART

1110
00:47:31,000 --> 00:47:32,160
AND THEY WERE SUPPORTIVE OF THIS

1111
00:47:32,160 --> 00:47:33,720
PROGRAM, THE GAP FILLING MODEL

1112
00:47:33,720 --> 00:47:37,040
SPLITTING TO TWO CONCEPTS MADE

1113
00:47:37,040 --> 00:47:38,560
LONGCAL SENSE, THE PROGRAM IS

1114
00:47:38,560 --> 00:47:40,080
PRACTICAL AND ESSENTIAL TO

1115
00:47:40,080 --> 00:47:43,160
DEVELOPING AND DELIVERING

1116
00:47:43,160 --> 00:47:43,760
PRODUCTS.

1117
00:47:43,760 --> 00:47:44,920
. THEY SUPPORTED THE IDEA

1118
00:47:44,920 --> 00:47:45,920
ALLOWING MORE SPECIALIZED AND

1119
00:47:45,920 --> 00:47:47,840
SMALLER ORGANIZATIONS TO SUPPORT

1120
00:47:47,840 --> 00:47:50,400
SPECIALIZED AREAS AND INCREASE

1121
00:47:50,400 --> 00:47:51,320
COMPETITION, THEY DID

1122
00:47:51,320 --> 00:47:54,080
ACKNOWLEDGE THE VOLUME OF PCS

1123
00:47:54,080 --> 00:47:59,160
ACCOMPLISHMENTS SINCE THE PAST

1124
00:47:59,160 --> 00:48:01,120
MID -- AND ALSO DISCUSS SECTORS

1125
00:48:01,120 --> 00:48:04,200
WE DISCUSS SECTORS THAT USE

1126
00:48:04,200 --> 00:48:05,200
SERVICES WHICH DR. HEWITT

1127
00:48:05,200 --> 00:48:07,640
PROVIDED FOR THIS WHOLE GROUP.

1128
00:48:07,640 --> 00:48:09,520
AND A SUGGESTION I AGREE WITH,

1129
00:48:09,520 --> 00:48:11,000
WE CAN INCREASE AWARENESS OF THE

1130
00:48:11,000 --> 00:48:12,000
PROGRAM TO THE SCIENCE

1131
00:48:12,000 --> 00:48:14,280
COMMUNITY. WE HAVE A PRETTY

1132
00:48:14,280 --> 00:48:16,400
SOLID APPROACH HOW WE DO

1133
00:48:16,400 --> 00:48:17,520
OUTREACH BUT ALWAYS BETTER WAYS

1134
00:48:17,520 --> 00:48:19,520
TO DO IT.  I APPRECIATE THAT

1135
00:48:19,520 --> 00:48:24,680
FEEDBACK. ANY QUESTIONS YOU HAVE

1136
00:48:24,680 --> 00:48:30,720
AT THIS TIME?

1137
00:48:30,720 --> 00:48:33,600
>>ANY QUESTIONS FROM
COUNCIL

1138
00:48:33,600 --> 00:48:36,960
MEMBERS ONLINE OR IN THE ROOM? 

1139
00:48:36,960 --> 00:48:44,080
THIS PROPOSAL?

1140
00:48:44,080 --> 00:48:46,240
>>REALLY SUPPORTIVE OF
THIS

1141
00:48:46,240 --> 00:48:48,880
PROGRAM. IT HAS BEEN SHOWN HOW

1142
00:48:48,880 --> 00:48:51,440
PRODUCTIVE IT IS, IT IS ADJUSTED

1143
00:48:51,440 --> 00:48:53,320
TO THE CHANGING ENVIRONMENT,

1144
00:48:53,320 --> 00:48:55,080
SPLITTING IT INTO TWO MAKES

1145
00:48:55,080 --> 00:49:00,440
TOTAL SENSE. REITERATE MY

1146
00:49:00,440 --> 00:49:08,200
SUPPORT. 

1147
00:49:08,200 --> 00:49:12,920
>>I CAN ECHO THAT AS
WELL. THIS

1148
00:49:12,920 --> 00:49:15,800
IS DR. BOCKENSTEDT. WE CAN'T SEE

1149
00:49:15,800 --> 00:49:17,040
YOUR FACE BECAUSE THE SLIDES,

1150
00:49:17,040 --> 00:49:19,760
THERE WE GO. THANK YOU.  I'M

1151
00:49:19,760 --> 00:49:21,640
VERY SUPPORTIVE OF THIS, ALL THE

1152
00:49:21,640 --> 00:49:23,560
REASONS LISTED THERE, I THINK

1153
00:49:23,560 --> 00:49:25,640
THAT GETTING MORE AWARENESS TO

1154
00:49:25,640 --> 00:49:26,920
THE SCIENTIFIC COMMUNITY OUT

1155
00:49:26,920 --> 00:49:31,320
THERE, EVEN PEOPLE WHO TEND TO

1156
00:49:31,320 --> 00:49:32,760
FINE THINGS THEY -- FIND THE

1157
00:49:32,760 --> 00:49:33,960
THINGS THEY NEED WHEN THEY NEED

1158
00:49:33,960 --> 00:49:36,240
THEM AND NOT SOMETHING THAT

1159
00:49:36,240 --> 00:49:39,800
SOMETHING THEY PLAN FOR

1160
00:49:39,800 --> 00:49:42,160
NECESSARILY ALONG -- IN ADVANCE

1161
00:49:42,160 --> 00:49:42,800
SO VERY IMPORTANT TO CONTINUE

1162
00:49:42,800 --> 00:49:50,840
THIS.

1163
00:49:50,840 --> 00:49:53,960
>>OUR SECOND CONCEPT
CONTINUING

1164
00:49:53,960 --> 00:49:55,960
ON PRE-CLINICAL SERVICES THEME

1165
00:49:55,960 --> 00:49:59,440
DR. LARRY WOLFRAIM WILL PREVENT

1166
00:49:59,440 --> 00:50:01,720
TESTING AND OTHER VACCINES AND

1167
00:50:01,720 --> 00:50:04,720
OTHER BIOLOGICS FOR INFECTIOUS

1168
00:50:04,720 --> 00:50:04,920
DISEASE.

1169
00:50:04,920 --> 00:50:08,560
>>GOOD AFTERNOON,
EVERYONE. I'M

1170
00:50:08,560 --> 00:50:12,080
DR. LARRY WOLFRAIM, CHIEF OF

1171
00:50:12,080 --> 00:50:13,200
BIODEFENSE VACCINES AND OTHER

1172
00:50:13,200 --> 00:50:14,360
BIOLOGICAL PRODUCTS DEVELOPMENT

1173
00:50:14,360 --> 00:50:16,680
SECTION. THAT'S THE FIRST

1174
00:50:16,680 --> 00:50:18,600
ACRONYM. OFFICE OF BIODEFENSE

1175
00:50:18,600 --> 00:50:19,800
RESEARCHERS AND TRANSLATIONAL

1176
00:50:19,800 --> 00:50:22,720
RESEARCH. SO NOW WE ARE DONE

1177
00:50:22,720 --> 00:50:24,840
WITH ACRONYMS WITH DMID. NOW I

1178
00:50:24,840 --> 00:50:26,240
WILL PRESENT ON CONCEPT

1179
00:50:26,240 --> 00:50:28,080
EVALUATION AND TESTING SERVICES

1180
00:50:28,080 --> 00:50:30,080
FOR VACCINES AND BUY LOGICS,

1181
00:50:30,080 --> 00:50:32,320
MORE LIKELY TO REFER TO AS THE

1182
00:50:32,320 --> 00:50:33,720
VACCINE TESTING CONTRACT FOR

1183
00:50:33,720 --> 00:50:38,520
SIMPLICITY.  I'M DRIVING THE

1184
00:50:38,520 --> 00:50:40,120
BUS. SO THE OBJECTIVE IS TO

1185
00:50:40,120 --> 00:50:44,160
PROVIDE A SUITE OF PRE-CLINICAL

1186
00:50:44,160 --> 00:50:45,600
NON-CLINICAL AND CLINICAL

1187
00:50:45,600 --> 00:50:46,960
SERVICES AND ASSAYS, VACCINES

1188
00:50:46,960 --> 00:50:48,800
AND OTHER BIOLOGIC PRODUCTS.

1189
00:50:48,800 --> 00:50:51,800
THIS IS A RENEWAL. THE MECHANISM

1190
00:50:51,800 --> 00:50:56,440
IS AN IDIQ. ANTICIPATED NUMBER

1191
00:50:56,440 --> 00:50:58,200
OF AWARDS BETWEEN ONE AND FIVE

1192
00:50:58,200 --> 00:51:02,920
FOR EACH TASK AREA. THIS SLIDE

1193
00:51:02,920 --> 00:51:03,680
SPEAKS TO IMPORTANCE OF

1194
00:51:03,680 --> 00:51:07,040
SCIENTIFIC NEED. A LOT OF THIS

1195
00:51:07,040 --> 00:51:08,360
MY COLLEAGUE DR. HEWITT WENT

1196
00:51:08,360 --> 00:51:10,120
OVER IN HER TALK. THESE ARE GAP

1197
00:51:10,120 --> 00:51:11,800
FILLING SERVICES, BASICALLY ONE

1198
00:51:11,800 --> 00:51:16,680
OFFS, IF YOU WILL. TO PROVIDE

1199
00:51:16,680 --> 00:51:18,320
CRITICAL SERVICES TO FILL GAPS

1200
00:51:18,320 --> 00:51:19,560
FOR MEDICAL COUNTER MEASURES IN

1201
00:51:19,560 --> 00:51:23,120
THIS CASE, THE VACCINES OR OTHER

1202
00:51:23,120 --> 00:51:26,240
BIOLOGICS TO PROGRESS ALONG THE

1203
00:51:26,240 --> 00:51:27,400
PATHWAY TO WHAT EVENTUAL

1204
00:51:27,400 --> 00:51:30,320
LICENSURE. THAT'S IN CONTRAST TO

1205
00:51:30,320 --> 00:51:32,040
OUR PD OR PRODUCT DEVELOPMENT

1206
00:51:32,040 --> 00:51:35,440
CONTRACT AND VAAs WHICH IS DR.

1207
00:51:35,440 --> 00:51:36,760
HEWITT EXPLAINED ARE DIFFERENT

1208
00:51:36,760 --> 00:51:39,680
THEY ENCOMPASS EVERYTHING THEY

1209
00:51:39,680 --> 00:51:42,160
NEED TO ADVANCE VACCINE

1210
00:51:42,160 --> 00:51:46,160
CANDIDATE FROM PROOF OF CONCEPT,

1211
00:51:46,160 --> 00:51:48,000
PRE-CLINICAL DATA THROUGH TO

1212
00:51:48,000 --> 00:51:48,960
INITIATION, COMPLETION OF PHASE

1213
00:51:48,960 --> 00:51:51,600
1 TRIAL.  THESE ARE GAP FILLING

1214
00:51:51,600 --> 00:51:55,200
IN CONTRAST. WHAT WE CAN DO WITH

1215
00:51:55,200 --> 00:51:56,680
VACCINE TESTING PRE-CLINICAL

1216
00:51:56,680 --> 00:51:59,440
SERVICES CONTRACT IS TO PROVIDE

1217
00:51:59,440 --> 00:52:00,840
NON-CLINICAL EFFICACY AND

1218
00:52:00,840 --> 00:52:02,840
IMMUNOGEN AT THISTY DATA TO

1219
00:52:02,840 --> 00:52:04,800
SUPPORT CLINICAL GO NO GO

1220
00:52:04,800 --> 00:52:05,800
DECISIONS, ON THE PART OF THE

1221
00:52:05,800 --> 00:52:08,560
PRODUCT DEVELOPERS. HELP DEFINE

1222
00:52:08,560 --> 00:52:10,440
OR REFINE PRODUCT FORMULATIONS

1223
00:52:10,440 --> 00:52:13,080
INCLUDING DOSE AND SCHEDULE.

1224
00:52:13,080 --> 00:52:17,920
VERY POPULAR TASK AREA HERE IS

1225
00:52:17,920 --> 00:52:19,840
TALKS OR SAFETY STUDIES,

1226
00:52:19,840 --> 00:52:22,480
TYPICALLY GLP IND ENABLING

1227
00:52:22,480 --> 00:52:25,920
STUDIES. GOING TO ALSO PROVIDE

1228
00:52:25,920 --> 00:52:29,480
OTHER GAPS TO FILL IND PACKAGES.

1229
00:52:29,480 --> 00:52:31,400
WE CAN DEVELOP CRITICAL ASSAYS

1230
00:52:31,400 --> 00:52:32,840
AND INTERNATIONAL STANDARDS WE

1231
00:52:32,840 --> 00:52:34,920
ARE DOING MORE RECENTLY, FOR

1232
00:52:34,920 --> 00:52:36,240
EXAMPLE WITH THE INTERNATIONAL

1233
00:52:36,240 --> 00:52:39,360
STANDARDS WE ARE WORKING IN

1234
00:52:39,360 --> 00:52:41,080
COLLABORATION WITH (INAUDIBLE)

1235
00:52:41,080 --> 00:52:43,080
TO DEVELOP WHO ANTIBODY

1236
00:52:43,080 --> 00:52:45,280
INTERNATIONAL STANDARDS FOR

1237
00:52:45,280 --> 00:52:47,400
MARCHBURG AND SUDAN. THESE

1238
00:52:47,400 --> 00:52:49,200
SERVICES CAN BE RAPIDLY DEPLOYED

1239
00:52:49,200 --> 00:52:52,160
TO SUPPORT OUTBREAK AND PANDEMIC

1240
00:52:52,160 --> 00:52:55,160
RESPONSE, RECENT EXAMPLE IS FOR

1241
00:52:55,160 --> 00:52:58,680
THE COVID-19 PANDEMIC, WE WERE

1242
00:52:58,680 --> 00:53:00,560
ABLE TO SET IN PLACE QUICKLY

1243
00:53:00,560 --> 00:53:02,560
TASK ORDERS TO DEVELOP CRITICAL

1244
00:53:02,560 --> 00:53:05,360
IMMUNE ASSAYS BUT DEVELOP THE

1245
00:53:05,360 --> 00:53:08,200
ASSAYS QUALIFY AND VALIDATE AND

1246
00:53:08,200 --> 00:53:09,000
ULTIMATELY TEST CLINICAL TRIALS

1247
00:53:09,000 --> 00:53:10,600
STAFF AND THAT WAS UNDER

1248
00:53:10,600 --> 00:53:12,400
AUSPICES OF THE US GOVERNMENT

1249
00:53:12,400 --> 00:53:13,720
WIDE RESPONSE THAT WAS THEN

1250
00:53:13,720 --> 00:53:16,960
KNOWN AS OPERATION WARP SPEED.

1251
00:53:16,960 --> 00:53:19,200
OVERALL WE ARE DERISKING

1252
00:53:19,200 --> 00:53:20,600
CANDIDATES TO SUPPORT FURTHER

1253
00:53:20,600 --> 00:53:22,080
ADVANCE DEVELOPMENT AND/OR

1254
00:53:22,080 --> 00:53:24,600
FUNDING SO FUNDING COULD BE

1255
00:53:24,600 --> 00:53:26,360
OTHER US GOVERNMENT AGENCIES,

1256
00:53:26,360 --> 00:53:28,560
OVER TRANSITION PARTNERS LIKE

1257
00:53:28,560 --> 00:53:30,560
BARTA. ALSO NON-PROFITS LIKE THE

1258
00:53:30,560 --> 00:53:31,880
BILL AND MELINDA GATES

1259
00:53:31,880 --> 00:53:36,200
FOUNDATION OR SEPE OR POSITION

1260
00:53:36,200 --> 00:53:39,440
THESE PROGRAMS FOR PRIVATE

1261
00:53:39,440 --> 00:53:41,640
EQUITY FUNDING. THE TYPE OF

1262
00:53:41,640 --> 00:53:43,840
QUESTIONS WE GET SPAN IT IS

1263
00:53:43,840 --> 00:53:45,960
GAMUT INDUSTRY, SMALL BIOTECH,

1264
00:53:45,960 --> 00:53:50,560
ACADEMIC INVESTIGATORS OR US

1265
00:53:50,560 --> 00:53:52,080
GOVERNMENT. THIS IS A HISTORY,

1266
00:53:52,080 --> 00:53:55,680
THIS IS A RECOMPETE. PREVIOUSLY

1267
00:53:55,680 --> 00:53:57,400
THERE WERE TWO AWARDS, THESE

1268
00:53:57,400 --> 00:54:01,200
WERE SINGLE AWARDS MADE TO THE

1269
00:54:01,200 --> 00:54:03,920
SAME ORGANIZATION, SO THE FIRST

1270
00:54:03,920 --> 00:54:07,040
CONTRACT RAN FROM 2012 THROUGH

1271
00:54:07,040 --> 00:54:09,200
2018. CURRENTLY ACTIVE CONTRACT

1272
00:54:09,200 --> 00:54:13,320
WAS AWARDED TO PATEL IN 2018.

1273
00:54:13,320 --> 00:54:14,680
FOR BOTH OF THESE THERE WERE

1274
00:54:14,680 --> 00:54:16,640
FIVE TASK AREAS VERSUS

1275
00:54:16,640 --> 00:54:18,000
ADMINISTRATIVE WHICH SUPPORTS

1276
00:54:18,000 --> 00:54:20,400
CONCEPT DEVELOPMENT PLANS,

1277
00:54:20,400 --> 00:54:21,760
INFORMATION REPORTS, SITE VISITS

1278
00:54:21,760 --> 00:54:24,520
OR AUDITS,S THE SECOND IS ASSAY

1279
00:54:24,520 --> 00:54:26,760
DEVELOPMENT FOR NON-CLINICAL AND

1280
00:54:26,760 --> 00:54:31,120
CLINICAL TESTINGING. THE THIRD S

1281
00:54:31,120 --> 00:54:33,400
NON-CLINICAL IMMUNOGENICITY AND

1282
00:54:33,400 --> 00:54:35,760
EFFICACY TESTING AND APPROPRIATE

1283
00:54:35,760 --> 00:54:38,640
ANIMAL MODELS SPANNING BSL 2 ALL

1284
00:54:38,640 --> 00:54:41,520
THE WAY TO BSL 4. NON-CLINICAL

1285
00:54:41,520 --> 00:54:44,200
AND CLINICAL SAMPLE TESTING THEN

1286
00:54:44,200 --> 00:54:46,080
FINALLY SAFETY AND TOXICITY

1287
00:54:46,080 --> 00:54:52,760
TESTING.  THIS SLIDE IS

1288
00:54:52,760 --> 00:54:54,280
SUMMARIZING, I WILL START ON THE

1289
00:54:54,280 --> 00:54:55,600
RIGHT HERE THE PIE CHART. SO

1290
00:54:55,600 --> 00:54:59,240
THIS IS SHOWING THE RELATIVE

1291
00:54:59,240 --> 00:55:00,360
REPORTS OF INDIVIDUAL TASK

1292
00:55:00,360 --> 00:55:02,600
ORDERS BY PATHOGEN WITH TWO

1293
00:55:02,600 --> 00:55:03,720
EXCEPTIONS WHICH I WILL MENTION

1294
00:55:03,720 --> 00:55:05,040
IN A MINUTE. INTERESTING WE DID

1295
00:55:05,040 --> 00:55:07,560
A LOT OF WORK ON THE RECENT

1296
00:55:07,560 --> 00:55:09,720
CONTRACT FOR SARS COV-2

1297
00:55:09,720 --> 00:55:12,360
INFLUENZA, FETAL VIRUSES, THEN

1298
00:55:12,360 --> 00:55:14,920
THE TWO WHICH ARE PATHOGEN

1299
00:55:14,920 --> 00:55:17,600
AGNOSTIC ARE BSL IV AND

1300
00:55:17,600 --> 00:55:19,000
TOXICOLOGY. EACH OF THESE ARE

1301
00:55:19,000 --> 00:55:21,000
SINGLE STANDING TASK ORDERS

1302
00:55:21,000 --> 00:55:25,440
UNDER WHICH WE CAN DO STUDIES

1303
00:55:25,440 --> 00:55:28,440
FOR ANY PATHOGEN BSL 4 PATHOGEN,

1304
00:55:28,440 --> 00:55:33,920
THE BSL 4 TOX STUDY, WHICH AM

1305
00:55:33,920 --> 00:55:35,920
COME DATES VACCINE CANDIDATES

1306
00:55:35,920 --> 00:55:37,800
FOR ANY PATHOGEN. IN TERMS OF

1307
00:55:37,800 --> 00:55:40,720
HOW WE ACCOMPLISH, WHAT I FOCUS

1308
00:55:40,720 --> 00:55:43,040
ON HERE ARE WAYS IN MANY WHICH

1309
00:55:43,040 --> 00:55:45,600
THE PRE-CLINICAL SERVICES FOR

1310
00:55:45,600 --> 00:55:47,400
VACCINE TESTING CONTRIBUTED TO

1311
00:55:47,400 --> 00:55:49,320
VACCINE CANDIDATES THAT HAVE

1312
00:55:49,320 --> 00:55:52,520
ULTIMATELY BEEN LICENSED.  THE

1313
00:55:52,520 --> 00:55:57,920
TOP HERE BIOTHORAX, EMERGENT ADA

1314
00:55:57,920 --> 00:56:01,360
POST EXPOSURE PROPHYLAXIS

1315
00:56:01,360 --> 00:56:03,680
VACCINE, SECOND EXAMPLE GOING TO

1316
00:56:03,680 --> 00:56:06,920
A LITTLE MORE DETAIL IS JANSEN

1317
00:56:06,920 --> 00:56:12,640
26 MVA EBOLA VACCINE, WE

1318
00:56:12,640 --> 00:56:15,880
PROVIDED A LOT IN TERMS OF

1319
00:56:15,880 --> 00:56:17,960
CONTRIBUTION FOR PRE-CLINICAL

1320
00:56:17,960 --> 00:56:18,960
SERVICES, MOST IMPORTANT OF

1321
00:56:18,960 --> 00:56:21,800
WHICH IS THE WHOLE IDEA OF

1322
00:56:21,800 --> 00:56:23,320
TESTING, THE I 26 TOGETHER WITH

1323
00:56:23,320 --> 00:56:26,360
THE NVA. THAT WAS DONE UNDER

1324
00:56:26,360 --> 00:56:27,920
PRE-CLINICAL SERVICES. SO JUST

1325
00:56:27,920 --> 00:56:30,720
TO GIVE A LITTLE BACKGROUND

1326
00:56:30,720 --> 00:56:32,160
THERE WERE TWO PRODUCT

1327
00:56:32,160 --> 00:56:35,560
DEVELOPMENT CONTRACTS UNDER VAA,

1328
00:56:35,560 --> 00:56:38,720
ONE TO JANSEN THE I 26 VECTOR

1329
00:56:38,720 --> 00:56:40,120
EBOLA VACCINE. THE OTHER

1330
00:56:40,120 --> 00:56:42,200
CONTRACT WAS AWARDED TO

1331
00:56:42,200 --> 00:56:44,960
(INAUDIBLE) THE MVA BASED

1332
00:56:44,960 --> 00:56:47,080
VACCINE CANDIDATE. NEITHER ONE

1333
00:56:47,080 --> 00:56:49,560
ALONE WAS SHOWING PROMISING

1334
00:56:49,560 --> 00:56:51,480
EFFICACY, NON-HUMAN PRIMATE

1335
00:56:51,480 --> 00:56:55,560
CHALLENGE MODEL WITH THE EBOLA. 

1336
00:56:55,560 --> 00:56:59,080
LOOKING AT THE LITERATURE THE

1337
00:56:59,080 --> 00:57:00,320
(INAUDIBLE) AT THAT TIME ON

1338
00:57:00,320 --> 00:57:02,320
THESE TWO CONTRACTS, SAW SET A

1339
00:57:02,320 --> 00:57:04,760
PRECEDENT FOR COMBINING THESE

1340
00:57:04,760 --> 00:57:06,560
TWO IN THE PRIME BOOST. WE

1341
00:57:06,560 --> 00:57:08,040
COULDN'T DO THAT, COULDN'T TEST

1342
00:57:08,040 --> 00:57:10,360
EFFICACY OF THE HETEROLOGOUS

1343
00:57:10,360 --> 00:57:13,520
PRIME BOOST UNDER THE BAA

1344
00:57:13,520 --> 00:57:15,720
CONTRACTS BECAUSE THE SCOPE OF

1345
00:57:15,720 --> 00:57:18,720
THOSE CONTRACTS IS LIMITED TO

1346
00:57:18,720 --> 00:57:19,640
VACCINE CANDIDATES THAT WERE IN

1347
00:57:19,640 --> 00:57:23,160
THE ORIGINAL PROPOSALS. SO THE

1348
00:57:23,160 --> 00:57:26,040
VACCINE TESTING SERVICES PROVIDE

1349
00:57:26,040 --> 00:57:27,800
MECHANISM WHEREBY WE CAN GET OUT

1350
00:57:27,800 --> 00:57:29,280
OF THE PROOF OF CONCEPT DATA AND

1351
00:57:29,280 --> 00:57:35,080
TURNED OUT SUCCESSFUL ULTIMATELY

1352
00:57:35,080 --> 00:57:38,840
JANSEN LICENSED THE NORDIC MVA

1353
00:57:38,840 --> 00:57:40,960
PA PART OF THE COMB POINT AND

1354
00:57:40,960 --> 00:57:43,280
PRIME BOOST REGIMEN VACCINE WAS

1355
00:57:43,280 --> 00:57:44,920
APPROVED IN EUROPE IN 2020. THE

1356
00:57:44,920 --> 00:57:49,360
NEXT EXAMPLE IS THE QUADRIVALENT

1357
00:57:49,360 --> 00:57:51,320
DENGE VACCINE, LICENSED IN

1358
00:57:51,320 --> 00:57:53,000
SEVERAL TERRITORIES NOW,

1359
00:57:53,000 --> 00:57:54,480
PRE-CLINICAL SERVICES PROVIDE

1360
00:57:54,480 --> 00:57:56,000
SUPPORT OF THAT PROGRAM. THEN

1361
00:57:56,000 --> 00:57:59,600
MOST RECENT EXAMPLE WAS THE NEXT

1362
00:57:59,600 --> 00:58:01,640
GENERATION ANTHRAX VACCINE. THIS

1363
00:58:01,640 --> 00:58:05,960
IS EMERGENT VIRAL SOLUTIONS,

1364
00:58:05,960 --> 00:58:09,040
BASICALLY THE FIRST ANTHRAX

1365
00:58:09,040 --> 00:58:11,000
VACCINE T FIRST BULLET ADA WITH

1366
00:58:11,000 --> 00:58:16,080
A SECOND ADJUVANT SETTING CPG

1367
00:58:16,080 --> 00:58:18,080
709. WHICH WAS APPROVED BY FDA

1368
00:58:18,080 --> 00:58:21,520
IN JULY OF THIS YEAR. THIS SLIDE

1369
00:58:21,520 --> 00:58:24,600
IS ADDRESSING THE OUTBREAK

1370
00:58:24,600 --> 00:58:26,280
RESPONSES TO OUTBREAKS AND

1371
00:58:26,280 --> 00:58:27,880
THREATS HOW PRE-CLINICAL

1372
00:58:27,880 --> 00:58:30,040
SERVICES THE VACCINE TESTING

1373
00:58:30,040 --> 00:58:32,120
CONTRACT SPECIFICALLY HAS MADE A

1374
00:58:32,120 --> 00:58:34,000
DIFFERENCE. SO FOR EBOLA I

1375
00:58:34,000 --> 00:58:36,560
TALKED ABOUT THE HETEROLOGOUS

1376
00:58:36,560 --> 00:58:38,160
PRIME BOOST AND A MECHANISM TO

1377
00:58:38,160 --> 00:58:39,920
DO THAT. WHAT THIS IS FOCUSING

1378
00:58:39,920 --> 00:58:42,920
ON, THIS IS THE PAPER IN THE

1379
00:58:42,920 --> 00:58:45,560
UPPER LEFT PUBLICATION

1380
00:58:45,560 --> 00:58:48,000
DESCRIBING THE CRITICAL

1381
00:58:48,000 --> 00:58:50,560
NON-HUMAN PRIMATE IMMUNOGENICITY

1382
00:58:50,560 --> 00:58:52,280
EFFICACY DATA GENERATED ON A

1383
00:58:52,280 --> 00:58:54,920
NUMBER OF TASK ORDERS WHICH WAS

1384
00:58:54,920 --> 00:58:57,920
USED FOR THEIR JANSEN

1385
00:58:57,920 --> 00:58:59,960
IMMUNOBRIDGING PACKAGE, VERY

1386
00:58:59,960 --> 00:59:01,360
INSTRUMENTAL GETTING THIS

1387
00:59:01,360 --> 00:59:02,640
VACCINE CANDIDATE LICENSED IN

1388
00:59:02,640 --> 00:59:06,680
THE EU. THE UPPER RIGHT IS

1389
00:59:06,680 --> 00:59:09,600
EXAMPLE FROM ZIKA. WE HAD A TASK

1390
00:59:09,600 --> 00:59:13,120
ORDER WHICH DEVELOPED AND

1391
00:59:13,120 --> 00:59:15,920
OPTIMIZED QUALIFIED ET CETERA,

1392
00:59:15,920 --> 00:59:17,640
NUMBER OF CLINICAL ASSAYS,

1393
00:59:17,640 --> 00:59:21,640
IMMUNE ASSAYS FOR ZIKA USED TO

1394
00:59:21,640 --> 00:59:22,640
TEST CLINICAL TRIALS SAMPLES

1395
00:59:22,640 --> 00:59:23,880
FROM A NUMBER OF PHASE 1

1396
00:59:23,880 --> 00:59:26,280
CLINICAL TRIALS. THE BOTTOM LEFT

1397
00:59:26,280 --> 00:59:31,360
IS SARS COV-2. HERE WHAT WAS

1398
00:59:31,360 --> 00:59:33,440
DONE, AGAIN LOT DONE UNDER

1399
00:59:33,440 --> 00:59:35,560
AUSPICES OF OPERATION WARP

1400
00:59:35,560 --> 00:59:36,640
SPEED. THIS PARTICULAR

1401
00:59:36,640 --> 00:59:38,680
PUBLICATION HERE, THE DATA IS

1402
00:59:38,680 --> 00:59:41,560
COMING FROM A LIVE VIRUS

1403
00:59:41,560 --> 00:59:42,920
MICRONEUTRALIZATION ASSAY, IT

1404
00:59:42,920 --> 00:59:46,520
WAS THE FIRST OF ITS KIND, THE

1405
00:59:46,520 --> 00:59:48,520
FIRST LIVE VIRUS MUTUALIZATION

1406
00:59:48,520 --> 00:59:50,640
ASSAY TO BE VALIDATED. IT WAS

1407
00:59:50,640 --> 00:59:54,000
USED TO TEST SAMPLES FROM THE

1408
00:59:54,000 --> 00:59:55,400
MODERNA PHASE 3 CLINICAL TRIALS,

1409
00:59:55,400 --> 00:59:57,600
THE DATA WAS USED IN BLA

1410
00:59:57,600 --> 00:59:59,080
SUBMISSION AS WELL AS ANALYSES

1411
00:59:59,080 --> 01:00:01,320
OF CORRELATES OF PROTECTION. 

1412
01:00:01,320 --> 01:00:04,120
BOTTOM RIGHT IS INFLUENZA. WE

1413
01:00:04,120 --> 01:00:07,160
DID TOX AND CLINICAL ASSAY

1414
01:00:07,160 --> 01:00:11,160
STUDIES AS WELL AS DEVELOPMENT

1415
01:00:11,160 --> 01:00:15,080
OF IMMUNE ASSAYS TO SUPPORT THE

1416
01:00:15,080 --> 01:00:16,680
CLINICAL TRIALS. IN THE MIDDLE

1417
01:00:16,680 --> 01:00:20,400
IS MPOX. HERE, WE TOOK AN ASSAY

1418
01:00:20,400 --> 01:00:23,160
THAT HAD ORIGINALLY BEEN USED TO

1419
01:00:23,160 --> 01:00:25,480
ASSESS NEUTRALIZING ANTIBODY

1420
01:00:25,480 --> 01:00:28,560
LEVELS TO VAX SINIA. THAT WAS

1421
01:00:28,560 --> 01:00:30,080
THE PLAQUE REDUCTION

1422
01:00:30,080 --> 01:00:31,640
NEUTRALIZATION TEST AND

1423
01:00:31,640 --> 01:00:34,120
OPTIMIZED FOR TESTING FOR

1424
01:00:34,120 --> 01:00:35,920
NEUTRALIZING ANTIBODY TITERS

1425
01:00:35,920 --> 01:00:38,040
MPOX AND THE ASSAY THAT WAS

1426
01:00:38,040 --> 01:00:40,120
OPTIMIZED THEN USED TO TEST

1427
01:00:40,120 --> 01:00:42,240
CLINICAL TRIALS FROM NIAID

1428
01:00:42,240 --> 01:00:43,840
SPONSORED PHASE 2 DOSE BARING

1429
01:00:43,840 --> 01:00:47,520
CLINICAL TRIAL USING THE

1430
01:00:47,520 --> 01:00:50,880
LICENSED (INDISCERNIBLE)

1431
01:00:50,880 --> 01:00:52,800
VACCINE. THIS SUMMARIZES THE

1432
01:00:52,800 --> 01:00:56,120
CHANGES WE ARE ENVISIONING FOR

1433
01:00:56,120 --> 01:00:58,240
2025, I MENTIONED EARLIER THE

1434
01:00:58,240 --> 01:01:01,960
FIRST ITERATIONS OF THIS

1435
01:01:01,960 --> 01:01:04,280
CONTRACT, 2012 AND CURRENTLY

1436
01:01:04,280 --> 01:01:07,720
2018 ARE SINGLE AWARDS TO THE

1437
01:01:07,720 --> 01:01:09,760
SAME OFFER, WHAT WE ARE

1438
01:01:09,760 --> 01:01:10,880
ANTICIPATING THIS YEAR, PLANNING

1439
01:01:10,880 --> 01:01:12,840
TO DO IS MAKE MULTIPLE AWARDS.

1440
01:01:12,840 --> 01:01:15,280
THE SINGLE AWARD IDEA TENDS TO

1441
01:01:15,280 --> 01:01:16,560
BE THE EXCEPTION. THIS CONTRACT

1442
01:01:16,560 --> 01:01:18,800
NOW MAYBE THE ONLY ONE WHICH IS

1443
01:01:18,800 --> 01:01:21,280
A SINGLE AWARD. THERE ARE LOT OF

1444
01:01:21,280 --> 01:01:24,640
ADVANTAGES FOR MULTIPLE AWARDS

1445
01:01:24,640 --> 01:01:26,800
COMPARED TO A SINGLE, SOME OF

1446
01:01:26,800 --> 01:01:28,160
THESE ARE MORE OBVIOUS THAN

1447
01:01:28,160 --> 01:01:29,640
OTHERS SO GREATER COMPETITION.

1448
01:01:29,640 --> 01:01:31,640
THE ABILITY TO PERHAPS DRIVE

1449
01:01:31,640 --> 01:01:34,160
DOWN COSTS, ACCESS NEWER

1450
01:01:34,160 --> 01:01:36,080
CAPABILITIES AND PERHAPS EVEN

1451
01:01:36,080 --> 01:01:38,360
BRING ON BOARD SMALL BUSINESS,

1452
01:01:38,360 --> 01:01:39,840
SMALL BUSINESSES WHICH IS

1453
01:01:39,840 --> 01:01:43,360
ANOTHER MANDATE. ONE PROBLEM WE

1454
01:01:43,360 --> 01:01:47,560
ARE RUNNING INTO NOW IS THAT

1455
01:01:47,560 --> 01:01:49,040
WITH THE INCUMBENT, IF WE WANT

1456
01:01:49,040 --> 01:01:52,240
TO DO STUDIES UNDER BSL 4

1457
01:01:52,240 --> 01:01:53,520
CONTAINMENT THAT HAS TO BE DONE

1458
01:01:53,520 --> 01:01:55,720
THROUGH SUBCONTRACTING BECAUSE

1459
01:01:55,720 --> 01:01:57,680
INCUMBENT DOESN'T HAVE THEIR OWN

1460
01:01:57,680 --> 01:01:59,680
BSL 4 FACILITIES. THEN MORE

1461
01:01:59,680 --> 01:02:01,080
RECENTLY THERE'S BEEN A CHANGE,

1462
01:02:01,080 --> 01:02:02,840
WE USED TO BE ABLE TO DO TOX

1463
01:02:02,840 --> 01:02:04,640
STUDIES, WITHOUT THE NEED FOR

1464
01:02:04,640 --> 01:02:06,200
SUBCONTRACTING BUT THAT IS

1465
01:02:06,200 --> 01:02:09,120
RECENTLY CHANGED BECAUSE THE

1466
01:02:09,120 --> 01:02:12,120
INCUMBENT HAS SPUN OFF TALKS --

1467
01:02:12,120 --> 01:02:13,440
TOX UNIT TO ANOTHER ENTITY SO

1468
01:02:13,440 --> 01:02:15,080
THEY HAVE TO DO THAT THROUGH

1469
01:02:15,080 --> 01:02:16,440
SUBCONTRACTING WHICH MAKES IT

1470
01:02:16,440 --> 01:02:18,080
MORE COMPLICATED AND ADDS

1471
01:02:18,080 --> 01:02:21,160
ADDITIONAL LAYERS OF COST. SO

1472
01:02:21,160 --> 01:02:24,680
THE MAJOR CHANGE HERE IS

1473
01:02:24,680 --> 01:02:27,040
PREVIOUSLY OFFERED TO RESPOND TO

1474
01:02:27,040 --> 01:02:32,200
ALL TASK AREAS.  FOR THIS

1475
01:02:32,200 --> 01:02:34,360
ITERATION WE ALLOW TO APPLY TO

1476
01:02:34,360 --> 01:02:36,040
SINGLE TASK AREA OR MULTIPLE. UP

1477
01:02:36,040 --> 01:02:37,040
TO THEM. THEY DON'T NEED TO

1478
01:02:37,040 --> 01:02:42,680
RESPONSE TO ALL OF THEM NOW.  WE

1479
01:02:42,680 --> 01:02:43,800
ARE TRYING TO STREAMLINE THE

1480
01:02:43,800 --> 01:02:47,120
TASK AREAS 2 AND 4. TWO IS ASSAY

1481
01:02:47,120 --> 01:02:49,440
DEVELOPMENT AND 4 IS CLINICAL

1482
01:02:49,440 --> 01:02:50,760
NON-CLINICAL SAMPLE TESTING NOW

1483
01:02:50,760 --> 01:02:54,880
A SINGLE TASK AREA. WE ARE ALSO

1484
01:02:54,880 --> 01:02:56,160
ELIMINATING ADMINISTRATIVE

1485
01:02:56,160 --> 01:02:57,400
SUPPORT, A SEPARATE TASK, WE

1486
01:02:57,400 --> 01:02:59,320
WANT TO BRING ADMINISTRATIVE

1487
01:02:59,320 --> 01:03:00,920
SUPPORT UNDER THE UMBRELLA OF

1488
01:03:00,920 --> 01:03:06,000
EACH AWARDED TASK ORDER.  SOME

1489
01:03:06,000 --> 01:03:10,040
OF THE FEEDBACK THAT I GOT, SOME

1490
01:03:10,040 --> 01:03:14,760
GRATEFUL TO PROFESSORS GREENBERG

1491
01:03:14,760 --> 01:03:15,480
ANDs THESE FOR THEIR COMMENTS.

1492
01:03:15,480 --> 01:03:18,080
-- ESTES FOR THEIR COMMENTS. ONE

1493
01:03:18,080 --> 01:03:19,400
COMMENT NOTE -- ONE COUNCIL

1494
01:03:19,400 --> 01:03:21,000
MEMBER NOTED GOING FROM SINGLE

1495
01:03:21,000 --> 01:03:23,120
AWARD TO MULTIPLE AWARD WOULD BE

1496
01:03:23,120 --> 01:03:26,120
MORE COMPLICATED TO MANAGE. THAT

1497
01:03:26,120 --> 01:03:27,480
IS TRUE, THERE WILL BE MORE

1498
01:03:27,480 --> 01:03:29,400
EFFORT ON THE PART OF THE

1499
01:03:29,400 --> 01:03:32,040
PROGRAM STAFF TO REVIEW THESE

1500
01:03:32,040 --> 01:03:33,440
PROPOSALS BECAUSE INSTEAD OF A

1501
01:03:33,440 --> 01:03:35,000
SINGLE PROPOSAL THERE COULD BE

1502
01:03:35,000 --> 01:03:36,720
MULTIPLE. IT MAY TAKE A LITTLE

1503
01:03:36,720 --> 01:03:38,800
LONGER TO ISSUE TASK ORDER

1504
01:03:38,800 --> 01:03:41,760
AWARDS AS A RESULT. HOWEVER THE

1505
01:03:41,760 --> 01:03:43,160
ADVANTAGE I ALLUDED TO EARLIER

1506
01:03:43,160 --> 01:03:46,040
THE INCREASE COMPETITION PERHAPS

1507
01:03:46,040 --> 01:03:48,960
GETTING A BETTER PRICE REDUCING

1508
01:03:48,960 --> 01:03:51,440
THE NEED TO SUBCONTRACT, THOSE

1509
01:03:51,440 --> 01:03:53,320
ALL OFFSET THE ADDITIONAL

1510
01:03:53,320 --> 01:03:55,920
COMPLEXITY WHEN IT COMES TO OUR

1511
01:03:55,920 --> 01:03:59,640
END TO MANAGE THES THESE. THE GS

1512
01:03:59,640 --> 01:04:00,920
ALWAYS TO SELECT THE

1513
01:04:00,920 --> 01:04:02,280
BEST-IN-CLASS CONTRACTORS FOR

1514
01:04:02,280 --> 01:04:05,400
EACH TASK AREA. THEN AFTER THE

1515
01:04:05,400 --> 01:04:07,800
POOLS ARE CREATED, WE ARE ALSO

1516
01:04:07,800 --> 01:04:11,280
GOING TO USE THE SAME STRATEGY

1517
01:04:11,280 --> 01:04:13,720
TO SELECT THE BEST WHEN WE GET

1518
01:04:13,720 --> 01:04:15,960
PROPOSALS FROM CONTRACTORS WHEN

1519
01:04:15,960 --> 01:04:19,000
WE ISSUE NEW VISUAL TASK ORDERS.

1520
01:04:19,000 --> 01:04:20,880
THERE IS ALSO A QUESTION I THINK

1521
01:04:20,880 --> 01:04:24,120
WHAT MY COLLEAGUE DR. HEWITT

1522
01:04:24,120 --> 01:04:25,800
ADDRESSED THIS VERY WELL BUT

1523
01:04:25,800 --> 01:04:28,800
HAPPY TO ANSWER ADDITIONAL

1524
01:04:28,800 --> 01:04:30,920
QUESTIONS, IT WAS DURING THE

1525
01:04:30,920 --> 01:04:32,240
PRESENTATION ON EARLIER SLIDE I

1526
01:04:32,240 --> 01:04:33,840
MENTION WE SUPPORTED VACCINE

1527
01:04:33,840 --> 01:04:36,360
TESTING CONTRACT MORE THAN 75

1528
01:04:36,360 --> 01:04:37,880
VACCINES OR BIOLOGIC CANDIDATES

1529
01:04:37,880 --> 01:04:40,720
BUT OF COURSE THE ENTIRE

1530
01:04:40,720 --> 01:04:42,200
UNIVERSE OF VACCINE AND

1531
01:04:42,200 --> 01:04:44,240
BIOLOGICS LARGER THAN 75. HOW TO

1532
01:04:44,240 --> 01:04:46,520
NARROW IT DOWN TO SUPPORT 75. I

1533
01:04:46,520 --> 01:04:50,840
THINK THAT WAS ADEQUATELY

1534
01:04:50,840 --> 01:04:54,120
ADDRESS THROUGH DETAILED SLIDE

1535
01:04:54,120 --> 01:04:57,280
DECK DR. HEWITT WENT THROUGH,

1536
01:04:57,280 --> 01:04:57,920
YOU CAN ADD ANYTHING TO THAT IF

1537
01:04:57,920 --> 01:04:59,000
YOU WOULD LIKE. THAT BRINGS ME

1538
01:04:59,000 --> 01:05:02,720
TO THE END OF MY PRESENTATION. 

1539
01:05:02,720 --> 01:05:04,240
THANK YOU, VERY MUCH FOR YOUR

1540
01:05:04,240 --> 01:05:06,960
TIME AND ATTENTION. I WOULD BE

1541
01:05:06,960 --> 01:05:08,920
HAPPY TO ANSWER ANY QUESTIONS

1542
01:05:08,920 --> 01:05:10,400
THAT YOU MIGHT HAVE. DR.

1543
01:05:10,400 --> 01:05:17,600
GREENBERG.

1544
01:05:17,600 --> 01:05:18,840
>>THANK YOU VERY MUCH.
THAT WAS

1545
01:05:18,840 --> 01:05:24,920
VERY INFORMATIVE. WONDERING IN

1546
01:05:24,920 --> 01:05:26,360
GENERAL I CAN THINK OF A LOT OF

1547
01:05:26,360 --> 01:05:30,680
TYPES OF USERS OF THIS SERVICE

1548
01:05:30,680 --> 01:05:34,440
INDUSTRY, ACADEMIA AND THE

1549
01:05:34,440 --> 01:05:35,120
INTRAMURAL PROGRAM (INAUDIBLE)

1550
01:05:35,120 --> 01:05:36,640
COMES TO MIND. DO YOU THINK IT

1551
01:05:36,640 --> 01:05:39,000
IS SORT OF A LITTLE BIT OF EACH?

1552
01:05:39,000 --> 01:05:41,720
OR IS ONE GROUP MUCH MORE

1553
01:05:41,720 --> 01:05:43,360
REPRESENT -- I WONDER WHO IS

1554
01:05:43,360 --> 01:05:43,760
USING IT?

1555
01:05:43,760 --> 01:05:47,600
>>I WOULD SAY WE ALL
THREE YOU

1556
01:05:47,600 --> 01:05:50,400
REFERENCE ARE REPRESENTED AS

1557
01:05:50,400 --> 01:05:51,760
TRUE. I WOULD SAY -- I THINK THE

1558
01:05:51,760 --> 01:05:56,040
BULK IS COMING FROM SOFT

1559
01:05:56,040 --> 01:05:56,880
COMPANIES AND ACADEMIC

1560
01:05:56,880 --> 01:06:00,280
INVESTIGATORS.  THAT IS MY

1561
01:06:00,280 --> 01:06:00,640
RECOLLECTION.

1562
01:06:00,640 --> 01:06:09,840
>>THANKS.

1563
01:06:09,840 --> 01:06:11,400
>>NICE PREGNANT. GREAT
YOU

1564
01:06:11,400 --> 01:06:13,880
PIVOT WITH YOUR EXPERIENCE TO

1565
01:06:13,880 --> 01:06:15,200
BREAK THIS UP. I HOPE YOU DO

1566
01:06:15,200 --> 01:06:17,040
HAVE THE EXTRA COMPETITION THAT

1567
01:06:17,040 --> 01:06:19,920
COMES IN WITH THIS. I THINK IT

1568
01:06:19,920 --> 01:06:21,600
IS A GOOD PROGRAM, CERTAINLY

1569
01:06:21,600 --> 01:06:24,600
VERY SUPPORTIVE OF CONTINUING TO

1570
01:06:24,600 --> 01:06:25,000
SUPPORT THIS.

1571
01:06:25,000 --> 01:06:34,880
>>THANK YOU. 

1572
01:06:34,880 --> 01:06:38,480
>>GO AHEAD.

1573
01:06:38,480 --> 01:06:40,640
>>KEN, YOU GO FIRST I
WILL GO

1574
01:06:40,640 --> 01:06:43,280
RIGHT AFTER.

1575
01:06:43,280 --> 01:06:46,560
>>JUST WONDERING THE
PREVIOUS

1576
01:06:46,560 --> 01:06:47,720
AWARD WERE THERE SUBCONTRACTS

1577
01:06:47,720 --> 01:06:50,040
FROM THAT SINGLE AWARD? AND WILL

1578
01:06:50,040 --> 01:06:51,840
BE POTENTIAL SUBCONTRACTS FROM

1579
01:06:51,840 --> 01:06:53,320
THESE INDIVIDUAL AWARDS ALSO?

1580
01:06:53,320 --> 01:06:55,600
>>THERE CERTAINLY WERE

1581
01:06:55,600 --> 01:06:57,000
INSTANCES -- RIGHT. SO THE

1582
01:06:57,000 --> 01:06:58,440
AWARDS WERE MADE -- THE INITIAL

1583
01:06:58,440 --> 01:07:00,240
AWARDS MADE TO THAT PRIME

1584
01:07:00,240 --> 01:07:01,600
CONTRACTOR INCUMBENT IN THIS

1585
01:07:01,600 --> 01:07:04,320
CASE PATEL. WHEN INDIVIDUAL

1586
01:07:04,320 --> 01:07:05,920
REQUEST FOR TASK ORDERS ARE

1587
01:07:05,920 --> 01:07:08,800
MADE, IT IS UP TO THE CONTRACTOR

1588
01:07:08,800 --> 01:07:10,120
TO DECIDE WHETHER OR NOT THEY

1589
01:07:10,120 --> 01:07:12,560
CAN DONNA HOUSE OR NEED TO

1590
01:07:12,560 --> 01:07:14,920
SUBCONTRACT. THERE'S CLEAR

1591
01:07:14,920 --> 01:07:17,120
EXAMPLES TO SUBCONTRACT. A

1592
01:07:17,120 --> 01:07:18,720
COUPLE I CITED WERE STUDIES THAT

1593
01:07:18,720 --> 01:07:20,760
NEED TO BE DONE UNDER BSL 4

1594
01:07:20,760 --> 01:07:21,760
CONTAINMENT SO THEY DON'T HAVE

1595
01:07:21,760 --> 01:07:23,240
THAT CAPABILITY AS NECESSITY,

1596
01:07:23,240 --> 01:07:25,440
THEY HAVE TO SUBCONTRACT.

1597
01:07:25,440 --> 01:07:27,560
PARTWAY THROUGH THE CURRENT

1598
01:07:27,560 --> 01:07:29,040
CONTRACT THEY LOST THEIR ABILITY

1599
01:07:29,040 --> 01:07:31,160
TO DO TOXICOLOGY STUDIES. THAT

1600
01:07:31,160 --> 01:07:32,920
IS A VERY POPULAR SERVICE WE

1601
01:07:32,920 --> 01:07:35,960
PROVIDE. SO NOW -- SO THEY SPUN

1602
01:07:35,960 --> 01:07:37,840
OFF A FOR PROFIT ENTITY

1603
01:07:37,840 --> 01:07:42,520
AMPLIFIED BIO, TOX STUDY BUS TO

1604
01:07:42,520 --> 01:07:44,200
ACCESS BIO IT IS A

1605
01:07:44,200 --> 01:07:48,120
SUBCONTRACTING MECHANISM. TO

1606
01:07:48,120 --> 01:07:50,920
ACCESS ANY OTHER CHARLES RIVER

1607
01:07:50,920 --> 01:07:54,000
OR ANY OTHER COMPANIES KNOWN FOR

1608
01:07:54,000 --> 01:07:57,520
TOX STUDIES WILL HAVE TO BE DONE

1609
01:07:57,520 --> 01:07:58,560
LIEU CURRENT CONTRACT TO

1610
01:07:58,560 --> 01:08:00,120
SUBCONTRACT TO PATEL. ADDING

1611
01:08:00,120 --> 01:08:02,000
COMPLEXITY, TIME, COST, SO

1612
01:08:02,000 --> 01:08:05,200
HOPING THAT WILL HAVE SOME

1613
01:08:05,200 --> 01:08:06,080
RESPONSES FROM ORGANIZATIONS

1614
01:08:06,080 --> 01:08:09,920
THAT CAN DO THE WORK THEMSELVES

1615
01:08:09,920 --> 01:08:12,000
AND THERE WILL BE A REDUCED NEED

1616
01:08:12,000 --> 01:08:17,480
TO SUBCONTRACT.  DR. PALMER. 

1617
01:08:17,480 --> 01:08:20,920
RELATED TO THAT, WHEN AN

1618
01:08:20,920 --> 01:08:22,200
ORGANIZATION APPLIES DO THEY

1619
01:08:22,200 --> 01:08:25,800
APPLY FOR THE DIFFERENT PARTS

1620
01:08:25,800 --> 01:08:27,360
INDIVIDUALLY OR Z A PACKAGE? THE

1621
01:08:27,360 --> 01:08:31,600
REASON I ASK IS OBVIOUSLY THEIR

1622
01:08:31,600 --> 01:08:32,720
COST STRUCTURE MATTERS IF YOU

1623
01:08:32,720 --> 01:08:34,480
BREAK THAT UP. CURIOUS ON THE

1624
01:08:34,480 --> 01:08:34,880
STRATEGY ON THAT.

1625
01:08:34,880 --> 01:08:37,120
>>THAT IS UP TO THE
OFFER. IF

1626
01:08:37,120 --> 01:08:39,880
THERE IS ONLY ONE TASK AREA,

1627
01:08:39,880 --> 01:08:40,960
WHERE THEY CAN BE RESPONSIVE TO

1628
01:08:40,960 --> 01:08:43,440
THEY CAN RESPOND TO THAT SINGLE

1629
01:08:43,440 --> 01:08:47,280
ONE. IF THEIR PROPOSAL LOOKS

1630
01:08:47,280 --> 01:08:49,280
GOOD, FROM A COST PERSPECTIVE

1631
01:08:49,280 --> 01:08:52,000
THE THEY WILL BE PART OF THAT

1632
01:08:52,000 --> 01:08:54,320
POOL. THEY CAN APPLY TO MULTIPLE

1633
01:08:54,320 --> 01:08:55,520
SO THEY WILL BE PART OF MULTIPLE

1634
01:08:55,520 --> 01:08:57,760
POOLS.  ASSUMING THE PROPOSALS

1635
01:08:57,760 --> 01:09:02,400
PASS MUSTER. THEN WE SEND

1636
01:09:02,400 --> 01:09:04,760
REQUEST FOR TASK ORDER

1637
01:09:04,760 --> 01:09:05,880
PROPOSALS, THOSE WILL GO OUT TO

1638
01:09:05,880 --> 01:09:07,520
THE CONTRACTORS IN THOSE

1639
01:09:07,520 --> 01:09:09,920
INDIVIDUAL POOLS.

1640
01:09:09,920 --> 01:09:11,400
>>THANK YOU.

1641
01:09:11,400 --> 01:09:14,120
>>SORT OF LIKE SETTING UP
A

1642
01:09:14,120 --> 01:09:15,400
CONSORTIUM EACH OF THESE

1643
01:09:15,400 --> 01:09:17,160
CONTRACTOR POOLS IS LIKE A

1644
01:09:17,160 --> 01:09:18,480
CONSORTIUM UNDER THE PARENT

1645
01:09:18,480 --> 01:09:20,920
CONTRACT OR AS DR. HEWITT

1646
01:09:20,920 --> 01:09:23,040
REFERRED TO IT AS A FISHING

1647
01:09:23,040 --> 01:09:25,880
LICENLICENSE. NO GUARANTEE YOU L

1648
01:09:25,880 --> 01:09:26,960
CATCH ANYTHING BUT AT LEAST YOU

1649
01:09:26,960 --> 01:09:30,640
HAVE THE POSSIBILITY OF CATCHING

1650
01:09:30,640 --> 01:09:30,920
SOMETHING.

1651
01:09:30,920 --> 01:09:32,280
>>THAT IS WHY THEY CALL
IT

1652
01:09:32,280 --> 01:09:33,760
FISHING AND NOT CATCHING.

1653
01:09:33,760 --> 01:09:37,560
>>THAT'S RIGHT. YES.

1654
01:09:37,560 --> 01:09:38,400
>>THANK YOU, LARRY.

1655
01:09:38,400 --> 01:09:41,680
>>THANK YOU. 

1656
01:09:41,680 --> 01:09:47,560
>>MOVING ON OUR NEXT
PRESENTER

1657
01:09:47,560 --> 01:09:49,800
IS DR. DAN STOUGHTON FROM THE

1658
01:09:49,800 --> 01:09:51,640
SAME SECTION, SAME OFFICE WITHIN

1659
01:09:51,640 --> 01:09:57,080
DMID. 

1660
01:09:57,080 --> 01:09:58,400
>>THANK YOU FOR LETTING
ME

1661
01:09:58,400 --> 01:10:00,160
PRESENT VACCINE AND OTHER

1662
01:10:00,160 --> 01:10:01,040
BIOLOGICS MANUFACTURING

1663
01:10:01,040 --> 01:10:02,600
CHARACTER SIXTH SERVICES. TAKE A

1664
01:10:02,600 --> 01:10:04,680
MOMENT TO COMMENT ON HOW WHAT

1665
01:10:04,680 --> 01:10:06,560
I'M GOING TO PRESENT IS VERY

1666
01:10:06,560 --> 01:10:07,680
SIMILAR TO WHAT YOU HEARD FROM

1667
01:10:07,680 --> 01:10:09,760
OTHER SERVICES, AND HOW

1668
01:10:09,760 --> 01:10:11,440
PRE-CLINICAL SERVICES INTERACT

1669
01:10:11,440 --> 01:10:12,360
TOGETHER WE LEARN FROM EACH

1670
01:10:12,360 --> 01:10:15,080
OTHER HOW TO DO CONTRACTING

1671
01:10:15,080 --> 01:10:17,480
TOGETHER AND WE DO SERVICES PART

1672
01:10:17,480 --> 01:10:19,720
TOGETHER TOO. WE ARE A VERY

1673
01:10:19,720 --> 01:10:23,240
INTEGRATED ORGANIZATION.  THE

1674
01:10:23,240 --> 01:10:24,920
OBJECTIVE PROVIDE A SUITE OF

1675
01:10:24,920 --> 01:10:25,920
MANUFACTURING SERVICES TO

1676
01:10:25,920 --> 01:10:27,800
SUPPORT MANUFACTURE OF

1677
01:10:27,800 --> 01:10:29,480
PRE-CLINICAL STUDIES AND ALSO

1678
01:10:29,480 --> 01:10:30,680
CLINICAL TRIAL MATERIAL.

1679
01:10:30,680 --> 01:10:32,040
FOCUSING ON PHASE 1 AND 2,

1680
01:10:32,040 --> 01:10:36,040
BECAUSE WE ARE LOOK AT DIFFERENT

1681
01:10:36,040 --> 01:10:38,240
CONCEPTS GOING INTO CLINIC AND

1682
01:10:38,240 --> 01:10:40,960
EXTENSIVE COST INCREASE WHEN YOU

1683
01:10:40,960 --> 01:10:43,880
GO TO MARKET PRODUCTS. THIS IS A

1684
01:10:43,880 --> 01:10:46,520
RENEWAL. IF APPROVED THIRD TIME

1685
01:10:46,520 --> 01:10:47,920
THROUGH LIKE LARRY SAID WE DID

1686
01:10:47,920 --> 01:10:50,600
THIS IN 2012, 2018 AND HOPEFULLY

1687
01:10:50,600 --> 01:10:55,800
2025. MECHANISM IS IDIQ HOWEVER

1688
01:10:55,800 --> 01:10:58,120
WE HAD CONTRACTORS THAT OFFER

1689
01:10:58,120 --> 01:11:00,120
OTHER FUND MECHANISMS AND WE ARE

1690
01:11:00,120 --> 01:11:02,720
OPEN AS NEEDED AS

1691
01:11:02,720 --> 01:11:03,720
PRO-APPROPRIATE. ANTICIPATED

1692
01:11:03,720 --> 01:11:05,200
NUMBER OF AWARDS ONE TO THREE

1693
01:11:05,200 --> 01:11:06,640
FOR EACH AREA. I WILL DISCUSS

1694
01:11:06,640 --> 01:11:09,320
THAT AND YOU WILL SEE A

1695
01:11:09,320 --> 01:11:12,000
RECURRING THEM AND CONTENT WE

1696
01:11:12,000 --> 01:11:13,320
PROVIDE AS SERVICE DOESN'T

1697
01:11:13,320 --> 01:11:15,760
CHANGE BUT HOW WE MAKE IT MORE

1698
01:11:15,760 --> 01:11:22,120
RIGHT SIZE TO MAKE IT CHANGE. SO

1699
01:11:22,120 --> 01:11:23,600
THE PRODUCTS WE SUPPORT ARE

1700
01:11:23,600 --> 01:11:25,000
VACCINES OTHER BIOLOGICS,

1701
01:11:25,000 --> 01:11:26,480
CHALLENGE MATERIAL FOR HUMAN

1702
01:11:26,480 --> 01:11:27,920
CHALLENGE STUDIES AND

1703
01:11:27,920 --> 01:11:29,440
PRE-CLINICAL STUDIES AND

1704
01:11:29,440 --> 01:11:33,040
ASSOCIATED VACCINE COMPONENTS,

1705
01:11:33,040 --> 01:11:35,840
ADJUVANTS CRITICAL REAGENTS,

1706
01:11:35,840 --> 01:11:38,040
ASSAY AGENT CELL BANKS.

1707
01:11:38,040 --> 01:11:39,480
PREDOMINANTLY BSL 2 BUT

1708
01:11:39,480 --> 01:11:41,720
CAPABILITY OF 3 AND 4 WHICH IS A

1709
01:11:41,720 --> 01:11:45,480
LITTLE UNUSUAL. THE SERVICES

1710
01:11:45,480 --> 01:11:48,440
STARTS WITH PRODUCT DEVELOPMENT

1711
01:11:48,440 --> 01:11:50,160
PLANS. THIS IS ONE OF THE FEW

1712
01:11:50,160 --> 01:11:51,680
PLACES WE ALLOW SOMEBODY WHO

1713
01:11:51,680 --> 01:11:53,360
DOESN'T KNOW WHAT THEY WANT TO

1714
01:11:53,360 --> 01:11:56,200
COME IN AND FIGURE OUT, HELP

1715
01:11:56,200 --> 01:11:57,720
CREATE A DRAFT PLAN TO TAKE A

1716
01:11:57,720 --> 01:12:02,560
NOVEL CANDIDATE FROM PROOF OF

1717
01:12:02,560 --> 01:12:04,480
CONCEPT THROUGH DEVELOPMENT

1718
01:12:04,480 --> 01:12:08,640
MANUFACTURING PRE-IND

1719
01:12:08,640 --> 01:12:10,000
TOXICOLOGY, AND WE CAN SHEPHERD

1720
01:12:10,000 --> 01:12:11,560
HOW TO DO THAT AND HELPS THEM

1721
01:12:11,560 --> 01:12:12,880
FIGURE WHAT THEY NEED TO DO AND

1722
01:12:12,880 --> 01:12:14,240
HOW THEY NEED TO DO IT. SO THIS

1723
01:12:14,240 --> 01:12:16,560
IS ONE OF THE SERVICES WE LIKE

1724
01:12:16,560 --> 01:12:18,200
TO KEEP IN BUT IT IS A PAPER

1725
01:12:18,200 --> 01:12:19,840
EXERCISE. SO WE FOUND THAT AS A

1726
01:12:19,840 --> 01:12:22,280
PAPER EXERCISE IT DOESN'T FIT

1727
01:12:22,280 --> 01:12:26,560
WITH WHAT A CMO DOES. CMOs DO

1728
01:12:26,560 --> 01:12:28,000
AUTHORIZATION, PROCESS

1729
01:12:28,000 --> 01:12:30,280
DEVELOPMENT, MANUFACTURING PROOF

1730
01:12:30,280 --> 01:12:33,480
REAGENTS, MANUFACTURING CLINICAL

1731
01:12:33,480 --> 01:12:34,840
TRIAL MATERIAL. MOVING ON TO

1732
01:12:34,840 --> 01:12:37,280
WHAT JUDY WAS TALKING ABOUT, WE

1733
01:12:37,280 --> 01:12:38,440
TEND TO GET TWO DIFFERENT

1734
01:12:38,440 --> 01:12:40,880
CLASSES OF PRODUCT TO DERISK

1735
01:12:40,880 --> 01:12:42,240
SOME THINGS. WE HAVE PRODUCT

1736
01:12:42,240 --> 01:12:44,880
SWITCH COME IN, WE DON'T

1737
01:12:44,880 --> 01:12:46,240
RECOMMEND SCALABLE, WE DON'T

1738
01:12:46,240 --> 01:12:48,320
KNOW IF WE CAN MAKE IT IN THE

1739
01:12:48,320 --> 01:12:50,760
GMP COMPLIANT MANNER. WE DON'T

1740
01:12:50,760 --> 01:12:57,560
THINK IT WILL PASS A STUDY

1741
01:12:57,560 --> 01:12:59,200
SECTION. SO THIS IS JUST TOO

1742
01:12:59,200 --> 01:13:00,960
RISKY. SO I PUT IN A YEAR'S

1743
01:13:00,960 --> 01:13:03,400
WORTH OF RESOURCES IN IT WE CAN

1744
01:13:03,400 --> 01:13:05,040
IDENTIFY WHETHER OR NOT WE CAN

1745
01:13:05,040 --> 01:13:06,640
MANUFACTURE THE PRODUCT THEN

1746
01:13:06,640 --> 01:13:08,080
CREATE VALUE TO PEOPLE COMING

1747
01:13:08,080 --> 01:13:11,080
BACK TRY FOG GET A VAA OR OTHER

1748
01:13:11,080 --> 01:13:14,280
CONTRACT OR FUNDING SUPPORT.  

1749
01:13:14,280 --> 01:13:15,840
ONE WE DIDN'T TALK ABOUT SO MUCH

1750
01:13:15,840 --> 01:13:17,680
IS WHEN WE DO THIS EARLY WORK,

1751
01:13:17,680 --> 01:13:19,080
IT IS VERY IMPORTANT THE

1752
01:13:19,080 --> 01:13:20,120
CONTRACT MANUFACTURING

1753
01:13:20,120 --> 01:13:20,920
ORGANIZATIONS DO NOT TAKE ANY

1754
01:13:20,920 --> 01:13:24,600
IP. SO ALL PRE-CLINICAL SERVICES

1755
01:13:24,600 --> 01:13:27,000
HAVE A DETERMINATION OF

1756
01:13:27,000 --> 01:13:27,800
EXCEPTIONAL CIRCUMSTANCE WHICH

1757
01:13:27,800 --> 01:13:31,000
MEANS THE CMOs ACT AS FIRST

1758
01:13:31,000 --> 01:13:33,360
FEE FOR SERVICE CONTRACT

1759
01:13:33,360 --> 01:13:35,600
ORGANIZATION AND ALL PROPRIETARY

1760
01:13:35,600 --> 01:13:36,600
INFORMATION AND ALL INDIVIDUAL

1761
01:13:36,600 --> 01:13:38,400
-- INTELLECTUAL PROPERTY FLOWS

1762
01:13:38,400 --> 01:13:39,680
BACK TO GOVERNMENT AND BACK TO

1763
01:13:39,680 --> 01:13:40,120
THE PRODUCT YOU KNOW

1764
01:13:40,120 --> 01:13:43,200
INVESTIGATOR. -- INNOVATOR. SO

1765
01:13:43,200 --> 01:13:45,960
DO NOT LOSE ANY OF THEIR

1766
01:13:45,960 --> 01:13:47,080
PROPRIETARY INFORMATION OR HAVE

1767
01:13:47,080 --> 01:13:48,000
SOMEBODY ELSE TAKE A PIECE OF

1768
01:13:48,000 --> 01:13:50,840
THE PIE. THE OTHER TYPE OF

1769
01:13:50,840 --> 01:13:54,040
PROJECT WE GET ARE FILL IN THE

1770
01:13:54,040 --> 01:13:55,920
GAPS.  SOMEBODY HAS A BA

1771
01:13:55,920 --> 01:13:57,600
CONTRACT AND THEY NEED A MASTER

1772
01:13:57,600 --> 01:13:59,400
CELL BANK, SOMEBODY DISCOVERED

1773
01:13:59,400 --> 01:14:01,320
THE PRODUCT ISN'T STABLE, THEY

1774
01:14:01,320 --> 01:14:02,520
NEED FORMULATION STUDIES THAT

1775
01:14:02,520 --> 01:14:03,680
DOESN'T FIT THE SCOPE OR FUNDING

1776
01:14:03,680 --> 01:14:04,920
WHAT THEY ARE DOING AND ABLE TO

1777
01:14:04,920 --> 01:14:13,240
PROVIDE THAT AS WELL.  SO KEY

1778
01:14:13,240 --> 01:14:14,840
ACCOMPLISHMENTS IN 2018 SHOWN

1779
01:14:14,840 --> 01:14:16,320
HERE WE HAVE DONE FIVE PRODUCT

1780
01:14:16,320 --> 01:14:17,360
DEVELOPMENT PLANS PROCESS

1781
01:14:17,360 --> 01:14:21,040
DEVELOPMENT PROJECTS,

1782
01:14:21,040 --> 01:14:22,360
MANUFACTURE TWO CLINICAL TRIAL

1783
01:14:22,360 --> 01:14:23,640
MATERIALS, TALK ABOUT THAT IN A

1784
01:14:23,640 --> 01:14:26,200
MINUTE. WE HAVE HAD A LOT OF

1785
01:14:26,200 --> 01:14:27,360
MASTER BANK REQUESTS, AND

1786
01:14:27,360 --> 01:14:29,880
SPEAKING TO WHAT LARRY SAID

1787
01:14:29,880 --> 01:14:32,320
EARLIER, THE TOX STUDIES PRODUCT

1788
01:14:32,320 --> 01:14:33,680
DEVELOPERS OUTSOURCE MASTER

1789
01:14:33,680 --> 01:14:35,480
BANKS ANYWAY SO A POPULAR

1790
01:14:35,480 --> 01:14:36,560
SERVICE TO REQUEST. BECAUSE IT

1791
01:14:36,560 --> 01:14:38,200
IS A POPULAR SERVICE WE RETHINK

1792
01:14:38,200 --> 01:14:39,760
HOW TO PROVIDE THAT TO THE

1793
01:14:39,760 --> 01:14:42,880
GREATER COMMUNITY.  ENHANCING

1794
01:14:42,880 --> 01:14:45,800
FORMULATION STUDIES IN 2017,

1795
01:14:45,800 --> 01:14:46,960
2016, FIVE MIXING STUDIES.

1796
01:14:46,960 --> 01:14:48,200
CURRENTLY WE DON'T HAVE ANY.

1797
01:14:48,200 --> 01:14:49,720
THAT IS SOMETHING WE MAY COME UP

1798
01:14:49,720 --> 01:14:51,760
AND HAVE IN THE FUTURE.

1799
01:14:51,760 --> 01:14:53,080
STABILITY STUDIES ALSO FAIRLY

1800
01:14:53,080 --> 01:14:54,880
COMMON THING TO REQUEST TO

1801
01:14:54,880 --> 01:14:57,280
EXTEND STABILITY STUDIES FOR

1802
01:14:57,280 --> 01:14:58,360
PRODUCT WHICH THE CONTRACT IS

1803
01:14:58,360 --> 01:15:04,200
LANGUAGE. WHAT ARE THE SPECIFIC

1804
01:15:04,200 --> 01:15:05,120
ACCOMPLISHMENTS? WITH THE

1805
01:15:05,120 --> 01:15:07,000
PRODUCT DEVELOPMENT PLANS, WE

1806
01:15:07,000 --> 01:15:09,680
HAVE DONE PDPs FOR PRODUCT

1807
01:15:09,680 --> 01:15:13,880
PANS FOR INFLUENZA,

1808
01:15:13,880 --> 01:15:19,480
TUBERCULOSIS, COMMON -- MRRS,

1809
01:15:19,480 --> 01:15:21,960
LANDSCAPE ANALYSIS FOR MERS. WE

1810
01:15:21,960 --> 01:15:24,080
HAVE DONE PROCESS FOR DIFFERENT

1811
01:15:24,080 --> 01:15:26,840
VACCINE CANDIDATES MICROBIAL

1812
01:15:26,840 --> 01:15:29,800
RECOMBINANT PROTEIN CANDIDATES

1813
01:15:29,800 --> 01:15:30,840
AND VIRAL CANDIDATES.  YOU CAN

1814
01:15:30,840 --> 01:15:32,160
SEE WITH THE MASTER BANKS WE

1815
01:15:32,160 --> 01:15:35,080
HAVE DONE A LOT OF MASTER BANK

1816
01:15:35,080 --> 01:15:39,360
WORK. SPANNING MAMMALIAN AND

1817
01:15:39,360 --> 01:15:41,400
SPANNING VIRAL AND MAMMALIAN

1818
01:15:41,400 --> 01:15:42,960
CELL LIVE DERIVED, TAKE A MOMENT

1819
01:15:42,960 --> 01:15:47,120
TO IDENTIFY OR FOCUS ON THE FIVE

1820
01:15:47,120 --> 01:15:49,000
STAPH AUREUS PROJECT WHERE ALL

1821
01:15:49,000 --> 01:15:50,600
FIVE WENT TO A PENALTY VALENT

1822
01:15:50,600 --> 01:15:54,120
VACCINE CANDIDATE FOR CARBX

1823
01:15:54,120 --> 01:15:56,160
CONTRACT CANDIDATE SIMILAR TO

1824
01:15:56,160 --> 01:15:59,840
JUDY TALKED ABOUT AND HUMANIZED

1825
01:15:59,840 --> 01:16:04,520
CK CELL LINE THAT SUPPORTS

1826
01:16:04,520 --> 01:16:05,960
MANUFACTURE OF FLU VACCINE

1827
01:16:05,960 --> 01:16:08,800
CANDIDATES. AS SHOWN HERE WE

1828
01:16:08,800 --> 01:16:10,000
ALSO DID CLINICAL TRIAL MATERIAL

1829
01:16:10,000 --> 01:16:12,520
WITH INACTIVATED WEST NILE VIRUS

1830
01:16:12,520 --> 01:16:14,320
OCCURRING NOW, KNOCK ON WOOD,

1831
01:16:14,320 --> 01:16:16,680
HOPEFULLY WE WILL BE SUCCESSFUL.

1832
01:16:16,680 --> 01:16:20,040
MANUFACTURING H 3N 2 INFLUENZA

1833
01:16:20,040 --> 01:16:21,280
VIRUS OR HUMAN CHALLENGE

1834
01:16:21,280 --> 01:16:23,200
MATERIAL GONE INTO A DOSE

1835
01:16:23,200 --> 01:16:23,960
RANGING CLINICAL TRIAL AND WE

1836
01:16:23,960 --> 01:16:25,480
ARE HOPING THAT DATA WILL COME

1837
01:16:25,480 --> 01:16:31,440
OUT IN ABOUT SIX MONTHS.  SO

1838
01:16:31,440 --> 01:16:35,320
WHAT HAVE WE LEARNED? ONE OF THE

1839
01:16:35,320 --> 01:16:36,840
DIFFICULTIES WITH THE VACCINES

1840
01:16:36,840 --> 01:16:39,240
AND OTHER BIOLOGICS IS PLATFORMS

1841
01:16:39,240 --> 01:16:40,560
ARE BROADER AND MORE

1842
01:16:40,560 --> 01:16:43,720
CHALLENGING. WE HAVE VIRAL

1843
01:16:43,720 --> 01:16:45,120
VACCINES, WE HAVE (INAUDIBLE)

1844
01:16:45,120 --> 01:16:47,320
BASED PRODUCTS MICROBIAL BASED

1845
01:16:47,320 --> 01:16:49,440
PRODUCTS YEAST BASED PRODUCTS. 

1846
01:16:49,440 --> 01:16:50,880
INSECT BASED PRODUCTS SO WE HAVE

1847
01:16:50,880 --> 01:16:52,800
TO HAVE A WIDE VARIETY OF

1848
01:16:52,800 --> 01:16:54,240
PLATFORMS FOR VACCINE

1849
01:16:54,240 --> 01:16:56,320
IMMUNOGENS.  WE ALSO FOUND OUT

1850
01:16:56,320 --> 01:16:58,800
THAT AS RICK SAID BEFORE AS

1851
01:16:58,800 --> 01:17:00,800
WELL, NOT ALL TASK AREAS ARE

1852
01:17:00,800 --> 01:17:03,240
WELL MATCHED TO WHAT THE

1853
01:17:03,240 --> 01:17:04,240
CONTRACTING MANUFACTURING

1854
01:17:04,240 --> 01:17:07,880
ORGANIZATIONS DO. THE PDP IS ONE

1855
01:17:07,880 --> 01:17:09,800
EASIEST EXAMPLE THAT WE NEED TO

1856
01:17:09,800 --> 01:17:11,280
FIND A WRITING ORGANIZATION TO

1857
01:17:11,280 --> 01:17:12,320
HELP WITH PRODUCT DEVELOPMENT

1858
01:17:12,320 --> 01:17:15,080
PLANS AS OPPOSED TO CONTRACT

1859
01:17:15,080 --> 01:17:15,920
MANUFACTURING ORGANIZATION. WITH

1860
01:17:15,920 --> 01:17:20,760
THE CMO ONLY FOCUSING ON

1861
01:17:20,760 --> 01:17:22,200
MANUFACTURING AND QUALITY AND

1862
01:17:22,200 --> 01:17:24,320
CMC DOCUMENTS HAVING REALLY NO

1863
01:17:24,320 --> 01:17:26,760
EXPERTISE IN TOXICOLOGY,

1864
01:17:26,760 --> 01:17:28,000
CLINICAL TRIAL DESIGN AND

1865
01:17:28,000 --> 01:17:30,760
INDs.  SO WE NEED THE RIGHT

1866
01:17:30,760 --> 01:17:32,000
ORGANIZATION TO PROVIDE THE

1867
01:17:32,000 --> 01:17:35,200
RIGHT SERVICE. THE OTHER WRINKLE

1868
01:17:35,200 --> 01:17:36,440
THAT WE HAVE COMPARED TO SOME OF

1869
01:17:36,440 --> 01:17:39,960
THE OTHER PEOPLE YOU HEARD SPEAK

1870
01:17:39,960 --> 01:17:43,280
EARLIER IS WE REQUESTED OF THE

1871
01:17:43,280 --> 01:17:44,520
REMAINING CHEMISTRY TYPE OF

1872
01:17:44,520 --> 01:17:46,120
WORK, THE CONTRACTORS COULD DO

1873
01:17:46,120 --> 01:17:50,240
IT ALL. WE CAN DO DEVELOPMENT,

1874
01:17:50,240 --> 01:17:56,920
MASTER SEEDS, DO MANUFACTURING

1875
01:17:56,920 --> 01:17:59,760
TO SCALE, WE LIMITED THE POOL OF

1876
01:17:59,760 --> 01:18:01,600
CONTRACTORS AND WE EXCLUDED

1877
01:18:01,600 --> 01:18:03,480
COMPANIES THAT MAKE MASTER VIRAL

1878
01:18:03,480 --> 01:18:05,040
SEATS. THERE'S A LOT OF

1879
01:18:05,040 --> 01:18:06,520
COMPANIES THAT MAKE MASTER VIRAL

1880
01:18:06,520 --> 01:18:08,080
SEATS AT THE 250 VIRAL RANGE, DO

1881
01:18:08,080 --> 01:18:09,640
IT ACROSS THE BOARD TIME AND

1882
01:18:09,640 --> 01:18:13,000
AGAIN, BUT THEY DON'T DO

1883
01:18:13,000 --> 01:18:16,160
CHROMATOGRAPHY, THEY DON'T

1884
01:18:16,160 --> 01:18:18,520
SKDs SO WE WANT TO FOCUS THAT

1885
01:18:18,520 --> 01:18:23,600
TO DO THAT TYPE OF WORK. SO HOW

1886
01:18:23,600 --> 01:18:26,400
DO WE CHANGE THE STRUCTURE? THE

1887
01:18:26,400 --> 01:18:27,640
CONTENT ISN'T GOING TO CHANGE.

1888
01:18:27,640 --> 01:18:29,360
WE ARE JUST GOING TO RIGHT SIZE

1889
01:18:29,360 --> 01:18:33,040
HOW WE ARE DOING IT.  THE -- WE

1890
01:18:33,040 --> 01:18:34,840
TRADITIONALLY HAD ADMIN AND

1891
01:18:34,840 --> 01:18:37,200
TECHNICAL MANAGEMENT TASK AREA,

1892
01:18:37,200 --> 01:18:38,880
DISAPPEARING AS A STAND ALONE

1893
01:18:38,880 --> 01:18:40,240
TASK, INCLUDED TO EVERY OTHER

1894
01:18:40,240 --> 01:18:44,000
CONTRACT WE HAVE. THE PRODUCT

1895
01:18:44,000 --> 01:18:48,280
DEVELOPMENT PLANS EXTRACTED FROM

1896
01:18:48,280 --> 01:18:49,360
CMOs, CARVE OUT INDIVIDUAL

1897
01:18:49,360 --> 01:18:51,560
TASK AREA FOR PDP LANDSCAPE

1898
01:18:51,560 --> 01:18:52,680
REPORTS, HOPING TO FIND

1899
01:18:52,680 --> 01:18:56,920
DEDICATED REGULATORY AFFAIRS

1900
01:18:56,920 --> 01:18:57,760
ORGANIZATIONS, OTHER TYPE OF

1901
01:18:57,760 --> 01:18:59,040
ORGANIZATIONS TO PROVIDE THIS

1902
01:18:59,040 --> 01:19:01,960
SUPPORT. THE REMAINING CHEMISTRY

1903
01:19:01,960 --> 01:19:03,080
WE WILL BREAK INTO THREE

1904
01:19:03,080 --> 01:19:04,120
SECTIONS, BASED ON WHAT WE SEE

1905
01:19:04,120 --> 01:19:11,520
IN THE PAST AS WELL. SOME CMOs

1906
01:19:11,520 --> 01:19:14,000
IN OUR CURRENT POOL DO

1907
01:19:14,000 --> 01:19:15,600
ANTIMICROBIAL WORK OUTSOURCE

1908
01:19:15,600 --> 01:19:17,920
DEVELOPMENT WORK SO GREAT TO GO

1909
01:19:17,920 --> 01:19:18,440
STRAIGHT THROUGH THOSE

1910
01:19:18,440 --> 01:19:19,640
ORGANIZATIONS AND NOT A PRIME

1911
01:19:19,640 --> 01:19:20,840
CONTRACTOR TO A SUBCONTRACTOR

1912
01:19:20,840 --> 01:19:23,880
FOR THE REASONS YOU HER EARLIER

1913
01:19:23,880 --> 01:19:25,000
TODAY. PRODUCT OPTIMIZATION,

1914
01:19:25,000 --> 01:19:27,040
PROCESS DEVELOPMENT AND NON-GMP

1915
01:19:27,040 --> 01:19:29,480
MANUFACTURING IS ONE TASK AREAS

1916
01:19:29,480 --> 01:19:31,320
GMP MANUFACTURING IS A SECOND

1917
01:19:31,320 --> 01:19:32,680
AND MASTER BANKS WILL BE A THIRD

1918
01:19:32,680 --> 01:19:36,960
TASK AREA. THAT IS HOW WE

1919
01:19:36,960 --> 01:19:38,720
ENVISION CHANGING WHAT WE

1920
01:19:38,720 --> 01:19:40,600
HAVEN'T DEVELOPED IN THE PAST TO

1921
01:19:40,600 --> 01:19:46,240
HOW WE DO IT MOVING FORWARD.  SO

1922
01:19:46,240 --> 01:19:47,600
AGAIN WE GOT RELATIVELY -- WE

1923
01:19:47,600 --> 01:19:50,280
HAVE POSITIVE FEEDBACK, THE

1924
01:19:50,280 --> 01:19:51,400
SCOPE IS QUITE LARGE, I DON'T

1925
01:19:51,400 --> 01:19:53,440
KNOW THAT WE CAN DO IT OTHER

1926
01:19:53,440 --> 01:19:56,360
THAN MANAGE THAT SCOPE. QUESTION

1927
01:19:56,360 --> 01:19:58,280
WAS ON HOW WE VETTED PROJECTS,

1928
01:19:58,280 --> 01:20:00,280
JUDY PROVIDED EXCELLENT

1929
01:20:00,280 --> 01:20:02,320
PRESENTATION ON THAT. THERE WAS

1930
01:20:02,320 --> 01:20:04,200
A QUESTION HOW DO WE DO FAILURE?

1931
01:20:04,200 --> 01:20:06,800
RICK TALKED ABOUT FAILING EARLY,

1932
01:20:06,800 --> 01:20:09,040
FAILING CHEAP OPPOSED TO FAILING

1933
01:20:09,040 --> 01:20:11,360
LATE.  I THOUGHT WE GO THROUGH

1934
01:20:11,360 --> 01:20:13,800
THE FAILURES WE HAVE BECAUSE

1935
01:20:13,800 --> 01:20:16,600
THEY ARE ALL DIFFERENT. SOME ARE

1936
01:20:16,600 --> 01:20:19,600
FAILURES BUT SOME GO BACK TO BE

1937
01:20:19,600 --> 01:20:21,520
R&D MAKING NEXT GENERATION

1938
01:20:21,520 --> 01:20:23,440
VERSION OF THAT SAME CANDIDATE. 

1939
01:20:23,440 --> 01:20:25,680
SO WE HAVE A RHINO VIRUS PRODUCT

1940
01:20:25,680 --> 01:20:27,840
DEVELOPMENT PLAN TO MAKE A

1941
01:20:27,840 --> 01:20:30,880
MULTI-VALENT VACCINE. WE HAD

1942
01:20:30,880 --> 01:20:33,440
EXPLAINED TO THE PRODUCT

1943
01:20:33,440 --> 01:20:37,280
INNOVATOR THAT 20 TO 50 IS STILL

1944
01:20:37,280 --> 01:20:42,480
TOO HIGH SO THEY KNEW THAT BUT

1945
01:20:42,480 --> 01:20:44,760
THEY JUST DIDN'T QUITE -- TO

1946
01:20:44,760 --> 01:20:47,520
HELP THEM FOCUS, IDENTIFY HOW

1947
01:20:47,520 --> 01:20:49,040
THEY COME UP WITH CONSENSUS

1948
01:20:49,040 --> 01:20:50,960
SEQUENCES HOW TO COME UP WITH

1949
01:20:50,960 --> 01:20:53,040
MORE NARROW SCOPE AND A STEP

1950
01:20:53,040 --> 01:20:55,000
WISE FASHION WORK THROUGH TO A

1951
01:20:55,000 --> 01:20:57,920
GOOD CANDIDATE. WE HAVE A

1952
01:20:57,920 --> 01:20:58,840
PROTEIN VACCINE CANDIDATE

1953
01:20:58,840 --> 01:21:00,440
UNUSUAL ON MOLECULAR LEVEL BUT

1954
01:21:00,440 --> 01:21:03,080
ALSO DISCOVERED THERE WAS A

1955
01:21:03,080 --> 01:21:05,080
LICENSING PROBLEM THAT

1956
01:21:05,080 --> 01:21:06,240
INNOVATOR, KNEW ABOUT BUT HASN'T

1957
01:21:06,240 --> 01:21:10,240
THOUGHT THROUGH. BY THE TIME YOU

1958
01:21:10,240 --> 01:21:12,320
FINISH MAKING PDP THEY

1959
01:21:12,320 --> 01:21:13,680
DISCOVERED THEY WERE BLOCKED,

1960
01:21:13,680 --> 01:21:15,560
NOT ABLE TO USE THAT LICENSE WAS

1961
01:21:15,560 --> 01:21:17,240
GOING TO STOP MOVING FORWARD.

1962
01:21:17,240 --> 01:21:19,680
BUT THEY COULD TAKE THE

1963
01:21:19,680 --> 01:21:21,840
INFORMATION AND WE DISCUSSED

1964
01:21:21,840 --> 01:21:24,240
PRODUCT OPTIMIZATION AND MADE A

1965
01:21:24,240 --> 01:21:25,440
NEXT GENERATION CANDIDATE THEY

1966
01:21:25,440 --> 01:21:29,200
CAN PATENT AND NOW HAVE COLLIE

1967
01:21:29,200 --> 01:21:30,440
FREE AND CLEAR TO DEVELOP THAT

1968
01:21:30,440 --> 01:21:34,160
CANDIDATE.  THAT IS A AN ITERATE

1969
01:21:34,160 --> 01:21:37,840
WIWIWIN. PARVO VIRUS B 19 FAILE,

1970
01:21:37,840 --> 01:21:39,800
COULDN'T MANUFACTURE. WE GOT A

1971
01:21:39,800 --> 01:21:41,080
PROCESS, TRIED, THOUGHT IT WOULD

1972
01:21:41,080 --> 01:21:42,320
WORK, WE HAD MULTIPLE PROBLEMS

1973
01:21:42,320 --> 01:21:43,320
WITH THAT PRODUCT AND WE FOUND

1974
01:21:43,320 --> 01:21:49,680
OUT THAT THE PROTEIN SUB UNIT

1975
01:21:49,680 --> 01:21:53,320
CHOSEN WOULD NEVER BE A SCALABLE

1976
01:21:53,320 --> 01:21:54,800
PRODUCT. THAT WAS A FAILURE,

1977
01:21:54,800 --> 01:21:59,760
TERMINATED PROJECT. HSV WAS

1978
01:21:59,760 --> 01:22:03,760
TERMINATED, MATERIAL WENT INTO A

1979
01:22:03,760 --> 01:22:05,880
NHP STUDY WHICH FAILED A

1980
01:22:05,880 --> 01:22:07,400
IMMUNOLOGICAL END POINT. FAILED

1981
01:22:07,400 --> 01:22:12,280
BUT FAILED FOR LOSS OF EFFICACY.

1982
01:22:12,280 --> 01:22:16,920
ADJUVENTS.  WE HAVE HAD -- WE

1983
01:22:16,920 --> 01:22:18,600
HAVE HAD A REAL PROBLEM TRYING

1984
01:22:18,600 --> 01:22:21,200
TO MAKE ADJUVANT, SOME SUCCESS

1985
01:22:21,200 --> 01:22:23,560
AND SOME FAILURES. TECHNICALLY

1986
01:22:23,560 --> 01:22:25,040
HELPING SUPPORT MANUFACTURING

1987
01:22:25,040 --> 01:22:26,080
ADJUVANT SHOULDN'T BE A

1988
01:22:26,080 --> 01:22:27,480
DIFFICULT PROBLEM. BUT THE

1989
01:22:27,480 --> 01:22:29,360
LICENSING BECOMES VERY

1990
01:22:29,360 --> 01:22:30,800
PROBLEMATIC. ON A FEW OCCASIONS

1991
01:22:30,800 --> 01:22:33,280
WE HAVE HAD ADJUVANT

1992
01:22:33,280 --> 01:22:35,480
MANUFACTURERS ALLOW US TO MAKE

1993
01:22:35,480 --> 01:22:37,320
ADJUNCT FOR A SPECIFIC PRODUCT

1994
01:22:37,320 --> 01:22:38,600
AND SPECIFIC PRODUCT YOU KNOW

1995
01:22:38,600 --> 01:22:39,440
INVESTIGATOR OR EXTERNAL

1996
01:22:39,440 --> 01:22:42,960
REQUESTER, NOT AS A SERVICE TO

1997
01:22:42,960 --> 01:22:46,640
MULTIPLE PEOPLE. WE HAVE SOME

1998
01:22:46,640 --> 01:22:47,680
ADJUVANT MANUFACTURERS THAT

1999
01:22:47,680 --> 01:22:49,200
NEVER WORK WITH US, AND ONLY

2000
01:22:49,200 --> 01:22:52,320
WORK DIRECTLY WITH THE PRODUCT

2001
01:22:52,320 --> 01:22:53,400
INNOVATORS.  SO WE HAVE TO COME

2002
01:22:53,400 --> 01:22:55,320
UP WITH A WAY OR ACCEPT WHEN IS

2003
01:22:55,320 --> 01:22:56,840
THE LICENSING ISSUE THAT GETS IN

2004
01:22:56,840 --> 01:22:58,160
THE WAY AND WE CAN'T MOVE

2005
01:22:58,160 --> 01:23:02,360
FORWARD.  I THINK THAT ROUNDS UP

2006
01:23:02,360 --> 01:23:05,440
EVERYTHING I HAD SO PAUSE AND

2007
01:23:05,440 --> 01:23:12,120
ASK IF THERE'S QUESTIONS. 

2008
01:23:12,120 --> 01:23:14,480
>>SO LAST QUESTION I
HAVE, I

2009
01:23:14,480 --> 01:23:18,480
ACTUALLY TURNED ON THE

2010
01:23:18,480 --> 01:23:22,320
MICROPHONE. SAME QUESTION AS

2011
01:23:22,320 --> 01:23:26,920
BEFORE. WHO ARE YOUR USERS? ARE

2012
01:23:26,920 --> 01:23:30,800
THEY COMPANIES ACADEMIC? NIH, OR

2013
01:23:30,800 --> 01:23:37,160
SOME OTHER GROUP? IS THIS OPEN

2014
01:23:37,160 --> 01:23:40,560
TO FOREIGN ENTITIES OR ONLY TO

2015
01:23:40,560 --> 01:23:41,080
US COMPANIES?

2016
01:23:41,080 --> 01:23:49,280
>>GREAT QUESTION. I WOULD
SAY

2017
01:23:49,280 --> 01:23:51,760
DIFFERENT. VACCINE MANUFACTURING

2018
01:23:51,760 --> 01:23:54,120
LARGE PHARMA DOESN'T WANT TO

2019
01:23:54,120 --> 01:23:55,680
MAKE PROCESS DEVELOPMENT OTHER

2020
01:23:55,680 --> 01:23:57,960
THAN MASTER BANKS OR CRITICAL

2021
01:23:57,960 --> 01:24:00,120
REAGENTS SO THEY ARE MUCH LESS

2022
01:24:00,120 --> 01:24:04,360
INCLINED TO USE THESE SERVICES. 

2023
01:24:04,360 --> 01:24:05,080
PRODUCT DEVELOPMENT PLANS WE

2024
01:24:05,080 --> 01:24:07,600
DON'T GIVE TO EXSTRAY SEN DA IN

2025
01:24:07,600 --> 01:24:08,280
THE EMERGENCY WORLD BECAUSE THEY

2026
01:24:08,280 --> 01:24:09,560
KNOW HOW TO DO THE WORK.

2027
01:24:09,560 --> 01:24:12,080
ACADEMIC SCIENTISTS AN SMALL

2028
01:24:12,080 --> 01:24:13,680
COMPANIES WHO ARE GREAT

2029
01:24:13,680 --> 01:24:15,640
INNOVATORS BUT DON'T NECESSARILY

2030
01:24:15,640 --> 01:24:16,840
HAVE THE PRODUCT DEVELOPMENT

2031
01:24:16,840 --> 01:24:19,720
EXPERTISE.  IT HELPS THEM FIND

2032
01:24:19,720 --> 01:24:21,640
OUT THEY NEED TO FIND

2033
01:24:21,640 --> 01:24:24,440
STAKEHOLDERS TO HELP THEM OUT OR

2034
01:24:24,440 --> 01:24:25,280
SHAREHOLDER HELP THEM TO DO THE

2035
01:24:25,280 --> 01:24:32,600
WORK. WE HELP SOME

2036
01:24:32,600 --> 01:24:34,240
NON-GOVERNMENT ORGANIZATIONS WE

2037
01:24:34,240 --> 01:24:37,880
HAVE DONE SOME WORK FOR NIDDK

2038
01:24:37,880 --> 01:24:39,000
FOR PROJECT THEY HAD BECAUSE

2039
01:24:39,000 --> 01:24:42,120
THEY DIDN'T HAVE THE RESOURCES

2040
01:24:42,120 --> 01:24:46,440
AVAILABLE AND WE DID -- WE

2041
01:24:46,440 --> 01:24:47,160
MANUFACTURE PRIZE MATERIALS

2042
01:24:47,160 --> 01:24:49,680
WHICH AS JUDY SAID HELP SUPPORT

2043
01:24:49,680 --> 01:24:51,440
GRANTS WE CAN'T PROVIDE MONEY TO

2044
01:24:51,440 --> 01:24:53,520
BUT CAN PROVIDES A RESOURCE TO. 

2045
01:24:53,520 --> 01:24:55,040
>>THANKS.

2046
01:24:55,040 --> 01:24:57,080
>>I THINK DR. PALMER HAS
A

2047
01:24:57,080 --> 01:24:58,400
QUESTION. HE HAS HIS HANDS

2048
01:24:58,400 --> 01:25:03,120
RAISED. 

2049
01:25:03,120 --> 01:25:05,720
>>REITERATING ONE VERY

2050
01:25:05,720 --> 01:25:07,960
SUPPORTIVE OF THIS BUT ALSO THAT

2051
01:25:07,960 --> 01:25:10,840
LAST SLIDE I'M GLAD WAS ADDED

2052
01:25:10,840 --> 01:25:12,200
BECAUSE WHAT LOOKED LIKE

2053
01:25:12,200 --> 01:25:15,440
FAILURES ARE ACTUALLY SUCCESSES

2054
01:25:15,440 --> 01:25:16,800
BECAUSE YOU ARE IDENTIFYING

2055
01:25:16,800 --> 01:25:20,840
THESE VERY EARLY AND REDIRECTING

2056
01:25:20,840 --> 01:25:22,800
OR PUTTING ENERGY WHERE MORE

2057
01:25:22,800 --> 01:25:26,120
PRODUCTIVE. SO WE ALWAYS LIKE TO

2058
01:25:26,120 --> 01:25:28,160
SEE A SUCCESS WHERE SOMETHING IS

2059
01:25:28,160 --> 01:25:32,440
OUT IN A MARKET AND MAKING A

2060
01:25:32,440 --> 01:25:33,920
HEALTHCARE DIFFERENCE BUT THE

2061
01:25:33,920 --> 01:25:38,280
EARLY FAILURES BY PROVIDING THAT

2062
01:25:38,280 --> 01:25:39,760
WHOLE RANGE THAT SUITE OF

2063
01:25:39,760 --> 01:25:41,200
SUPPORT ACTIVITIES, I THINK IS

2064
01:25:41,200 --> 01:25:44,400
REALLY CRITICALLY IMPORTANT AND

2065
01:25:44,400 --> 01:25:49,360
ADDRESSES ONE MAJOR ISSUE THAT

2066
01:25:49,360 --> 01:25:51,520
HAPPENS ESPECIALLY WITH ACADEMIA

2067
01:25:51,520 --> 01:25:53,640
AND SMALL COMPANIES. GETTING

2068
01:25:53,640 --> 01:25:54,760
STARTED IN THIS. GREAT

2069
01:25:54,760 --> 01:25:57,120
PRESENTATION. I APPRECIATE THAT

2070
01:25:57,120 --> 01:26:03,320
EDITION.

2071
01:26:03,320 --> 01:26:08,960
>>OKAY. THANK YOU. THE
LAST OF

2072
01:26:08,960 --> 01:26:11,520
THE DMID CONCEPTS, WILL BE

2073
01:26:11,520 --> 01:26:13,160
PRESENTED BY JUDY HEWITT, YOU

2074
01:26:13,160 --> 01:26:18,800
HEARD FROM EARLIER, THIS IS

2075
01:26:18,800 --> 01:26:21,520
CONCEPT FOR THE NEXT VERSION OF

2076
01:26:21,520 --> 01:26:22,440
CENTERS OF EXCELLENCE FOR

2077
01:26:22,440 --> 01:26:23,600
TRANSLATIONAL RESEARCH.

2078
01:26:23,600 --> 01:26:27,000
>>I'M PRESENTING THIS ON
BEHALF

2079
01:26:27,000 --> 01:26:28,480
OF PAULA BRUNET WHO COULDN'T BE

2080
01:26:28,480 --> 01:26:30,840
HERE, SHE SENDS REGRETS, SHE HAD

2081
01:26:30,840 --> 01:26:36,080
A COLLEGE VISIT THAT WAS

2082
01:26:36,080 --> 01:26:37,280
SCHEDULED TODAY.  ON BEHALF OF

2083
01:26:37,280 --> 01:26:38,640
THE TEAM THAT WORKED ON THIS

2084
01:26:38,640 --> 01:26:45,720
CONCEPT AS WELL. THERE WE GO. SO

2085
01:26:45,720 --> 01:26:47,520
THE CENTERS OF EXCELLENCE FOR

2086
01:26:47,520 --> 01:26:53,000
TRANSLATIONAL RESEARCH OR

2087
01:26:53,000 --> 01:26:54,000
CETRs EXPAND PIPELINE OF

2088
01:26:54,000 --> 01:26:56,160
MEDICAL COUNTER MEASURES, FOR FY

2089
01:26:56,160 --> 01:26:58,200
25 WE PROPOSE TO FOCUS THAT

2090
01:26:58,200 --> 01:26:59,960
AGAINST BACTERIA AND FUNGI WITH

2091
01:26:59,960 --> 01:27:03,160
KNOWN EMERGING RESISTANCE. 

2092
01:27:03,160 --> 01:27:06,240
SUPPORTING TRANSLATIONAL

2093
01:27:06,240 --> 01:27:07,760
ACTIVITY SO BEYOND DISCOVERY

2094
01:27:07,760 --> 01:27:08,960
LIEU PRE-CLINICAL DEVELOPMENT TO

2095
01:27:08,960 --> 01:27:10,200
THE PRODUCT DEVELOPMENT PATHWAY.

2096
01:27:10,200 --> 01:27:13,200
THIS IS A RENEWAL THAT IN THE

2097
01:27:13,200 --> 01:27:16,400
PAST THE CETRs ARE U 19, WE

2098
01:27:16,400 --> 01:27:18,000
ARE HAPPY WITH THAT MECHANISM.

2099
01:27:18,000 --> 01:27:23,240
WE ARE PROPOSING 4 TO 6 AWARDS

2100
01:27:23,240 --> 01:27:25,680
AT 25 MILLION. SO GIVE YOU A

2101
01:27:25,680 --> 01:27:29,600
LITTLE BACKGROUNDETR PROGRAM. IN

2102
01:27:29,600 --> 01:27:31,800
THE BEGINNING IN 2003 WE AWARDED

2103
01:27:31,800 --> 01:27:34,360
THE FIRST REGIONAL CENTERS OF

2104
01:27:34,360 --> 01:27:36,520
EXCELLENCE. THESE WERE

2105
01:27:36,520 --> 01:27:39,840
BIODEFENSE AWARDS, RIGHT AFTER

2106
01:27:39,840 --> 01:27:43,480
9/11. THEY WERE FOCUSED ON

2107
01:27:43,480 --> 01:27:46,480
CATEGORY A A. RENEWED AGAIN IN

2108
01:27:46,480 --> 01:27:48,360
2009 SO THE REGIONAL CENTERS OF

2109
01:27:48,360 --> 01:27:52,360
EXCELLENCE WERE BASED ON THE TEN

2110
01:27:52,360 --> 01:27:55,400
REGIONS IN THE US.  ONE IN EACH

2111
01:27:55,400 --> 01:27:57,760
REGION. BIG AWARDS IN 2009 THE

2112
01:27:57,760 --> 01:27:59,880
RENEWAL WAS CATEGORY A THROUGH

2113
01:27:59,880 --> 01:28:04,920
C.  IN 2014 WE REFOCUSED A

2114
01:28:04,920 --> 01:28:06,800
LITTLE BIT, WHEN WE CALLED THEM

2115
01:28:06,800 --> 01:28:09,800
CENTERS OF EXCELLENCE FOR

2116
01:28:09,800 --> 01:28:10,760
TRANSLATIONAL RESEARCH SO WE

2117
01:28:10,760 --> 01:28:14,440
DIDN'T HAVE A STRICT BIODEFENSE

2118
01:28:14,440 --> 01:28:16,080
FOCUS THOUGH AGAIN CATEGORY A

2119
01:28:16,080 --> 01:28:17,840
THROUGH C AND EMERGING

2120
01:28:17,840 --> 01:28:20,960
INFECTIOUS DISEASES WERE SCOPE

2121
01:28:20,960 --> 01:28:25,120
OF THESE AWARDS. THESE WERE U

2122
01:28:25,120 --> 01:28:28,560
19s, THEY WERE RENEWED AGAIN

2123
01:28:28,560 --> 01:28:33,760
IN 2019 CETR 1.0 AND 2.0. THESE

2124
01:28:33,760 --> 01:28:39,360
ARE SYNERGISTIC MULTI-PROJECT

2125
01:28:39,360 --> 01:28:41,880
AWARDS WHERE INSTITUTION PICKS A

2126
01:28:41,880 --> 01:28:44,720
THEME FOR THEIR AWARD. FROM THIS

2127
01:28:44,720 --> 01:28:46,760
BROAD SCOPE OF CATEGORY A

2128
01:28:46,760 --> 01:28:48,160
THROUGH C EMERGING INFECTIOUS

2129
01:28:48,160 --> 01:28:49,800
DISEASES.  ONE OF THE

2130
01:28:49,800 --> 01:28:51,040
INTERESTING FEATURES THAT WE

2131
01:28:51,040 --> 01:28:54,520
LIKE ABOUT THESE AWARDS IS THAT

2132
01:28:54,520 --> 01:28:56,920
THEY HAVE A SAC OR SCIENTIFIC

2133
01:28:56,920 --> 01:28:58,520
ADVISORY COMMITTEE. SO THAT IS A

2134
01:28:58,520 --> 01:29:02,160
GROUP OF INDEPENDENTS OUTSIDE

2135
01:29:02,160 --> 01:29:04,480
EXPERTS THAT HAVE PRODUCT

2136
01:29:04,480 --> 01:29:06,960
DEVELOPMENT EXPERTISE WHETHER

2137
01:29:06,960 --> 01:29:08,760
INDUSTRY OR REGULATORY, SO THEY

2138
01:29:08,760 --> 01:29:13,440
CAN REALLY HELP THIS CETR FOCUS

2139
01:29:13,440 --> 01:29:17,160
ON PROJECTS MOVING FORWARD AND

2140
01:29:17,160 --> 01:29:19,080
GO NO GO DECISIONS. I WOULD LIKE

2141
01:29:19,080 --> 01:29:21,320
TO POINT OUT VERY LARGE SCOPE

2142
01:29:21,320 --> 01:29:23,760
BROAD SCOPE HERE LARGE NUMBER OF

2143
01:29:23,760 --> 01:29:28,760
AWARDS AND A LARGE DOLLAR AMOUNT

2144
01:29:28,760 --> 01:29:31,440
AS WELL. HERE ARE KEY

2145
01:29:31,440 --> 01:29:33,640
ACCOMPLISHMENTS FOR THE CETRs.

2146
01:29:33,640 --> 01:29:36,560
AT THE END OF 2022, THERE WERE

2147
01:29:36,560 --> 01:29:38,760
1300 PUBLICATIONS AND 86 PATENTS

2148
01:29:38,760 --> 01:29:41,560
SO THIS IS IMPRESSIVE THOUGH ONE

2149
01:29:41,560 --> 01:29:42,880
REVIEWERS POINTED OUT THAT IT IS

2150
01:29:42,880 --> 01:29:45,880
LIKELY THAT MANY OF THOSE

2151
01:29:45,880 --> 01:29:49,600
PUBLICATIONS WERE RELATED TO

2152
01:29:49,600 --> 01:29:51,640
COVID-19. WHICH BRINGS ME TO THE

2153
01:29:51,640 --> 01:29:55,880
NEXT BULLET, THIS CETRs PLAYED

2154
01:29:55,880 --> 01:29:57,880
A SIGNIFICANT ROLE IN OUR

2155
01:29:57,880 --> 01:29:59,280
COVID-19 RESPONSE SO THEY

2156
01:29:59,280 --> 01:30:03,680
QUICKLY PIVOTD TO TESTING

2157
01:30:03,680 --> 01:30:06,360
REMDESIVIR IN VITRO AND SMALL

2158
01:30:06,360 --> 01:30:07,960
ANIMAL MODELS AN ENABLED

2159
01:30:07,960 --> 01:30:09,160
PRODUCTS TO MOVE QUICKLY

2160
01:30:09,160 --> 01:30:12,640
RAPIDLY.  WE HAVE PUBLICATIONS

2161
01:30:12,640 --> 01:30:14,920
ON THE RIGHT SO THE ONE ON TOP

2162
01:30:14,920 --> 01:30:17,920
TALKS ABOUT NEUTRALIZING

2163
01:30:17,920 --> 01:30:26,600
ANTIBODIES FOR OMICRON, AGAIN

2164
01:30:26,600 --> 01:30:27,480
PART OF RESPONSE EFFORTS SO WE

2165
01:30:27,480 --> 01:30:29,160
HAD A NUMBER OF ACCOMPLISHMENTS

2166
01:30:29,160 --> 01:30:30,520
RELATED TO PANDEMIC

2167
01:30:30,520 --> 01:30:31,600
PREPAREDNESS, DEVELOPING MEDICAL

2168
01:30:31,600 --> 01:30:34,080
COUNTER MEASURES SO THIS SECOND

2169
01:30:34,080 --> 01:30:37,480
PUBLICATION HERE IS ANTIVIRAL

2170
01:30:37,480 --> 01:30:41,920
FOR ALPHA VIRUS. THAT IS MOVING

2171
01:30:41,920 --> 01:30:50,480
ALONG NICELY.  WE HAVE ALSO

2172
01:30:50,480 --> 01:30:52,600
MONOCLONALS AND VACCINES

2173
01:30:52,600 --> 01:30:55,000
SUPPORTED FOR SUDAN OUTBREAKS,

2174
01:30:55,000 --> 01:30:56,880
MOVE FORWARD FOR BARTA SUPPORT

2175
01:30:56,880 --> 01:30:59,640
AS WEL WELL. SO THAT IS THE THID

2176
01:30:59,640 --> 01:31:06,680
PUBLICATION HERE. WE HAVE CETR

2177
01:31:06,680 --> 01:31:09,960
ON ANTIMICROBIAL RESISTANCE, DID

2178
01:31:09,960 --> 01:31:12,400
LARGE NEW DISCOVERY PLATFORMS

2179
01:31:12,400 --> 01:31:14,120
IDENTIFICATION OF THERAPEUTIC

2180
01:31:14,120 --> 01:31:17,520
TARGETS AND BROAD SPECTRUM

2181
01:31:17,520 --> 01:31:25,560
ANTIBACTERIALS AND ANTI-FUNGALS.

2182
01:31:25,560 --> 01:31:28,240
IN CETR 3.0 WE FOCUS ON

2183
01:31:28,240 --> 01:31:31,560
ANTIMICROBIAL RESISTANCE. SO

2184
01:31:31,560 --> 01:31:34,000
THIS SLIDE IS MEANT TO POINT OUT

2185
01:31:34,000 --> 01:31:37,960
HOW IT FITS INTO OVERALL

2186
01:31:37,960 --> 01:31:40,000
PORTFOLIO, IT WILL BE A SLIGHTLY

2187
01:31:40,000 --> 01:31:42,080
SMALLER PROGRAM FEWER AWARDS,

2188
01:31:42,080 --> 01:31:43,520
SMALLER DOLLAR AMOUNT, LARGE

2189
01:31:43,520 --> 01:31:47,160
PART BECAUSE IT IS A REALLY VERY

2190
01:31:47,160 --> 01:31:50,760
FOCUSED PROGRAM. SO THIS NEXT

2191
01:31:50,760 --> 01:31:57,000
SLIDE -- SORRY. THIS SLIDE IS ON

2192
01:31:57,000 --> 01:31:58,880
THE IMPORTANCE OF FOCUSING ON

2193
01:31:58,880 --> 01:32:00,880
ANTIMICROBIAL RESISTANCE.

2194
01:32:00,880 --> 01:32:02,120
THERE'S SOME STALINGERRING

2195
01:32:02,120 --> 01:32:03,840
STATISTICS HERE -- STAGGERING

2196
01:32:03,840 --> 01:32:06,040
STATISTICS HERE, 5 MILLION

2197
01:32:06,040 --> 01:32:07,440
DEATHS GLOBALLY IN 2019

2198
01:32:07,440 --> 01:32:10,400
ASSOCIATED WITH ANTIMICROBIAL

2199
01:32:10,400 --> 01:32:12,680
RESISTANCE. 100 TRILLION IN

2200
01:32:12,680 --> 01:32:14,880
ECONOMIC COSTS. THAT IS OVER A

2201
01:32:14,880 --> 01:32:19,120
35 YEAR PERIOD BUT STILL A LOT

2202
01:32:19,120 --> 01:32:22,120
OF MONEY. THINKING ABOUT THIS

2203
01:32:22,120 --> 01:32:24,200
NOT IF BUT WHEN, NOW IS REALLY A

2204
01:32:24,200 --> 01:32:27,160
GOOD TIME TO BE FOCUSING ON

2205
01:32:27,160 --> 01:32:28,600
ANTIMICROBIAL RESISTANCE AN

2206
01:32:28,600 --> 01:32:32,360
RE-EMPHASIZING THIS AREA BECAUSE

2207
01:32:32,360 --> 01:32:36,560
AS WAS PRESENTED EARLIER OUR

2208
01:32:36,560 --> 01:32:37,720
RESPONSES HERE ARE GOING TO TAKE

2209
01:32:37,720 --> 01:32:40,200
TIME TO COME TO FRUITION SO WE

2210
01:32:40,200 --> 01:32:46,680
NEED TO FOCUS ON IT.  HERE IS

2211
01:32:46,680 --> 01:32:49,480
THE SLIDE HOW CETR 3.

2212
01:32:49,480 --> 01:32:50,560
0 FITS WITHIN THE RESEARCH

2213
01:32:50,560 --> 01:32:52,320
PORTFOLIO SO THE TEAM THAT GOT

2214
01:32:52,320 --> 01:32:54,680
TOGETHER TO THINK ABOUT THE CETR

2215
01:32:54,680 --> 01:32:55,960
AND WHAT WE WOULD FOCUS ON WHEN

2216
01:32:55,960 --> 01:32:59,520
WE WERE DISCUSSING THE RENEWAL,

2217
01:32:59,520 --> 01:33:02,160
LOOKED AT ALL THESE VERY LARGE

2218
01:33:02,160 --> 01:33:04,760
CENTER TYPE PROGRAMS THAT NIAID

2219
01:33:04,760 --> 01:33:10,160
DMID FUNDED OR WILL BE FUNDING.

2220
01:33:10,160 --> 01:33:11,440
BEGINNING WITH THE CENTERS OF

2221
01:33:11,440 --> 01:33:14,560
EXCELLENCE FOR INFLUENZA

2222
01:33:14,560 --> 01:33:16,360
RERESEARCH THAT FOCUSES

2223
01:33:16,360 --> 01:33:18,840
OBVIOUSLY ON FLU NATURAL HISTORY

2224
01:33:18,840 --> 01:33:23,440
TRANSMISSION PATHOGENESIS, AND

2225
01:33:23,440 --> 01:33:25,160
SURVEILLANCE AS WELL. NEXT WE

2226
01:33:25,160 --> 01:33:27,600
HAVE THE CREEDS CENTERS FOR

2227
01:33:27,600 --> 01:33:30,400
RESEARCH ON EMERGING INFECTIOUS

2228
01:33:30,400 --> 01:33:32,240
DISEASESSER MORE BASIC RESEARCH

2229
01:33:32,240 --> 01:33:34,400
AND SURVEILLANCE ON EMERGING

2230
01:33:34,400 --> 01:33:36,720
INFECTIOUS DISEASE AND

2231
01:33:36,720 --> 01:33:38,240
RE-EMERGING DISEASE. I WILL MOVE

2232
01:33:38,240 --> 01:33:40,840
TO THE RIGHT HAND SIDE HERE AND

2233
01:33:40,840 --> 01:33:43,840
TALK ABOUT THE AVIDS AND REVAMP

2234
01:33:43,840 --> 01:33:45,560
BOTH WHICH ARE FOCUSED ON

2235
01:33:45,560 --> 01:33:46,920
PANDEMIC PREPAREDNESS EFFORTS SO

2236
01:33:46,920 --> 01:33:49,840
THE AVIDS ARE ANTIVIRAL DRUG

2237
01:33:49,840 --> 01:33:51,720
DISCOVERY CENTERS SPECIFICALLY

2238
01:33:51,720 --> 01:33:54,440
LOOKING FOR DIRECT ACTING

2239
01:33:54,440 --> 01:33:55,920
ANTIVIRALS AGAINST THE SEVEN

2240
01:33:55,920 --> 01:33:58,320
VIRAL FAMILIES OF PANDEMIC

2241
01:33:58,320 --> 01:34:02,640
POTENTIAL. THE REVAMPS ARE BEING

2242
01:34:02,640 --> 01:34:04,440
REVIEWED NOW, THOSE ARE FOCUSING

2243
01:34:04,440 --> 01:34:06,120
ON VACCINE MONOCLONAL DISCOVERY

2244
01:34:06,120 --> 01:34:11,040
AND DEVELOPMENT CENTERS, FOR THE

2245
01:34:11,040 --> 01:34:13,960
SAME FAMILIES OF VIRUSES. MOVING

2246
01:34:13,960 --> 01:34:16,200
BACK TO THE LEFT INTO BACTERIA

2247
01:34:16,200 --> 01:34:19,440
HERE, WE HAVE THE IMPACT TB, THE

2248
01:34:19,440 --> 01:34:22,760
IMMUNE MECHANISMS OF PROTECTION

2249
01:34:22,760 --> 01:34:24,840
FOR TB CENTERS, THOSE ARE LOOK

2250
01:34:24,840 --> 01:34:27,640
AT BASIC IMMUNE RESPONSES. 

2251
01:34:27,640 --> 01:34:29,720
REQUIRED FOR PROTECTION AGAINST

2252
01:34:29,720 --> 01:34:34,280
TB. LASTLY TESTIFY NO -- CENTERS

2253
01:34:34,280 --> 01:34:36,400
FOR ANTIMICROBIAL RHESUS TAN

2254
01:34:36,400 --> 01:34:39,160
BACTERIA, INTERDISCIPLINARY

2255
01:34:39,160 --> 01:34:40,920
COMBATING ANTIMICROBIAL

2256
01:34:40,920 --> 01:34:42,520
RESISTANT BACTERIA

2257
01:34:42,520 --> 01:34:43,280
INTERDISCIPLINARY RESEARCH

2258
01:34:43,280 --> 01:34:44,880
UNITS.  THOSE ARE BASIC RESEARCH

2259
01:34:44,880 --> 01:34:47,520
LOOKING AT BACTERIAL AND HOST

2260
01:34:47,520 --> 01:34:49,440
FACTORS THAT ARE IMPORTANT FOR

2261
01:34:49,440 --> 01:34:51,840
DEVELOPING RESISTANCE AND WE

2262
01:34:51,840 --> 01:34:54,120
NEED TO POINT OUT THESE ARE

2263
01:34:54,120 --> 01:34:56,080
DESIGNED TO BE PRECETR, MORE OF

2264
01:34:56,080 --> 01:35:00,160
THE BAY SUCK RESEARCH AND COULD

2265
01:35:00,160 --> 01:35:02,760
POTENTIALLY FEED INTO A CETR BUT

2266
01:35:02,760 --> 01:35:06,400
ARE DISTANT. AGAIN CETR 3.0 IS

2267
01:35:06,400 --> 01:35:07,920
ABOUT DEVELOPING MEDICAL COUNTER

2268
01:35:07,920 --> 01:35:11,320
MEASURES FOR AMR BACTERIAL AND

2269
01:35:11,320 --> 01:35:13,680
URGENT FUNGAL THREATS. SO THIS

2270
01:35:13,680 --> 01:35:18,800
IS HOW WE ENVISION THE PROJECTS

2271
01:35:18,800 --> 01:35:21,840
OR PROPOSALS THAT MIGHT COME IN,

2272
01:35:21,840 --> 01:35:23,440
THEY COULD SPAN THERAPEUTICS,

2273
01:35:23,440 --> 01:35:25,920
VACCINES AND DIAGNOSTICS SO FOR

2274
01:35:25,920 --> 01:35:27,000
THERAPEUTIC APPROACHES WE ARE

2275
01:35:27,000 --> 01:35:29,280
THINKING NEW APPROACHES, NEW

2276
01:35:29,280 --> 01:35:31,080
THERAPEUTIC APPROACHES FOR

2277
01:35:31,080 --> 01:35:33,520
NON-TARGETS SO TARGET DISCOVERY

2278
01:35:33,520 --> 01:35:34,680
WAS IN THE (INAUDIBLE) BUT THIS

2279
01:35:34,680 --> 01:35:37,000
WOULD BE ADVANCING THAT LOOKING

2280
01:35:37,000 --> 01:35:38,640
FOR NEW THERAPEUTIC APPROACHES

2281
01:35:38,640 --> 01:35:40,560
FOR THOSE TARGETS. THINKING A

2282
01:35:40,560 --> 01:35:42,360
BIT ABOUT ALTERNATIVE

2283
01:35:42,360 --> 01:35:45,600
TECHNOLOGIES, FOR EXAMPLE, PHAGE

2284
01:35:45,600 --> 01:35:49,440
POTENT YEAH TORRS THAT COULD

2285
01:35:49,440 --> 01:35:51,640
RESTORE ANTIMICROBIAL

2286
01:35:51,640 --> 01:35:52,600
SUSCEPTIBILITY, THINKING ABOUT

2287
01:35:52,600 --> 01:35:54,760
THERAPEUTICS OR THINKING ABOUT

2288
01:35:54,760 --> 01:35:57,240
MONOTHERAPIES, COMBINATION,

2289
01:35:57,240 --> 01:36:00,440
ADJUDGETIVE THERAPY THE WHOLE

2290
01:36:00,440 --> 01:36:02,440
GAMUT. FOR VACCINES SOME

2291
01:36:02,440 --> 01:36:05,120
POSSIBLE APPROACHES OR SYSTEMS

2292
01:36:05,120 --> 01:36:08,760
VACCINOLOGY FOR IMMUNOGEN

2293
01:36:08,760 --> 01:36:10,320
DESIGN, INNOVATIVE VACCINE

2294
01:36:10,320 --> 01:36:12,080
TECHNOLOGIES, LAST BUT NOT

2295
01:36:12,080 --> 01:36:14,320
LEAST, DIAGNOSTICS, SO ONE OF

2296
01:36:14,320 --> 01:36:17,760
THE THINGS WE ARE THINKING ABOUT

2297
01:36:17,760 --> 01:36:21,160
HERE IS COUPLE DEVELOPMENT OF

2298
01:36:21,160 --> 01:36:22,680
PATHOGEN IDENTIFICATION

2299
01:36:22,680 --> 01:36:25,600
TECHNOLOGIES ALONG WITH

2300
01:36:25,600 --> 01:36:26,600
PHENOTYPIC SUSCEPTIBILITY

2301
01:36:26,600 --> 01:36:33,040
TESTING. SO FOR PATHOGEN

2302
01:36:33,040 --> 01:36:34,560
IDENTIFICATION TECHNOLOGIES WE

2303
01:36:34,560 --> 01:36:36,920
WOULD LIKE TO SEE SENSITIVE

2304
01:36:36,920 --> 01:36:39,200
CULTURAL INTERDEPENDENT

2305
01:36:39,200 --> 01:36:41,040
SENSITIVE PATHOGEN TESTING AND

2306
01:36:41,040 --> 01:36:42,840
WE THINK THAT PHENOTYPIC TESTING

2307
01:36:42,840 --> 01:36:45,960
IS GOING TO BE KEY THERE.  

2308
01:36:45,960 --> 01:36:47,320
ANOTHER THING WE SHOULD POINT

2309
01:36:47,320 --> 01:36:49,320
OUT IS WE ARE ANTICIPATING

2310
01:36:49,320 --> 01:36:52,320
CENTERS COME IN PROPOSING

2311
01:36:52,320 --> 01:36:55,480
VARIETY OF APPROACHES HERE,

2312
01:36:55,480 --> 01:36:56,640
THERAPEUTIC VACCINE OR

2313
01:36:56,640 --> 01:36:58,200
DIAGNOSTIC POTENTIALLY COMBINED

2314
01:36:58,200 --> 01:37:02,640
TOGETHER THEY DON'T HAVE TO PICK

2315
01:37:02,640 --> 01:37:05,440
ONE OR ANOTHER. IN TERMS OF THE

2316
01:37:05,440 --> 01:37:07,400
PATHOGENS WE ADAPTED THIS TABLE

2317
01:37:07,400 --> 01:37:13,280
FROM THE CDC ANTIMICROBIAL

2318
01:37:13,280 --> 01:37:16,120
RESISTANCE THREAT REPORT. SO WE

2319
01:37:16,120 --> 01:37:18,800
JUST FOCUSED ON FOR BACTERIA

2320
01:37:18,800 --> 01:37:20,720
THEIR URGENT AND SERIOUS THREATS

2321
01:37:20,720 --> 01:37:23,480
HERE. I WON'T GO THROUGH THIS

2322
01:37:23,480 --> 01:37:31,440
WHOLE LIST. FUNGI AS WELL R. FOR

2323
01:37:31,440 --> 01:37:33,320
COUNCIL FEEDBACK, WE WANT TO

2324
01:37:33,320 --> 01:37:36,280
THANK DR. TAYLOR AND

2325
01:37:36,280 --> 01:37:37,560
BOCKENSTEDT, THEY AGREED ON

2326
01:37:37,560 --> 01:37:40,400
FOCUSING CETRs ON

2327
01:37:40,400 --> 01:37:41,720
ANTIMICROBIAL RESISTANCE, IT WAS

2328
01:37:41,720 --> 01:37:43,320
IMPORTANT AND TIMELY ESPECIALLY

2329
01:37:43,320 --> 01:37:44,480
GIVEN THAT WE ARE MERGING OUT OF

2330
01:37:44,480 --> 01:37:47,520
THE COVID-19 PANDEMIC AND IT IS

2331
01:37:47,520 --> 01:37:49,160
TIME TO RE-EMPHASIZE

2332
01:37:49,160 --> 01:37:51,560
ANTIMICROBIAL RESISTANCE. ONE OF

2333
01:37:51,560 --> 01:37:55,880
THE QUESTIONS THEY ASKED WAS

2334
01:37:55,880 --> 01:37:56,520
WITH RESPECT (INAUDIBLE) SHOULD

2335
01:37:56,520 --> 01:37:59,560
BE INCLUDED, THAT IS CERTAINLY

2336
01:37:59,560 --> 01:38:04,080
-- IT WAS -- THERE WAS A RECENT

2337
01:38:04,080 --> 01:38:08,480
CDC HEALTH ALERT AROUND VIBRIAL

2338
01:38:08,480 --> 01:38:10,680
IN PARTICULAR WARMING COASTAL

2339
01:38:10,680 --> 01:38:13,520
WATERS, SO THEY -- ASKED WHETHER

2340
01:38:13,520 --> 01:38:14,880
WE SHOULD CONSIDER WORKING THIS

2341
01:38:14,880 --> 01:38:16,800
ON THE LIST. RIGHT NOW IT IS

2342
01:38:16,800 --> 01:38:19,680
CONSIDERED AMR PATHOGEN BY CDC

2343
01:38:19,680 --> 01:38:21,040
SO IT IS TECHNICALLY NOT ON THE

2344
01:38:21,040 --> 01:38:25,200
LIST, WE ARE GOING TO TALK WITH

2345
01:38:25,200 --> 01:38:27,240
CDC AND WATCH WHETHER THEY MIGHT

2346
01:38:27,240 --> 01:38:30,440
CONSIDER ADDING IT TO THEIR

2347
01:38:30,440 --> 01:38:32,560
WATCH LIST, AS OF RIGHT NOW WE

2348
01:38:32,560 --> 01:38:34,000
ARE NOT GOING TO CONSIDER IT

2349
01:38:34,000 --> 01:38:34,600
RESPONSIVE AT THIS POINT IN

2350
01:38:34,600 --> 01:38:37,280
TIME.  IT IS AN EXCELLENT POINT

2351
01:38:37,280 --> 01:38:41,120
THOUGH THAT CLIMATE CHANGE IS

2352
01:38:41,120 --> 01:38:43,440
IMPACTING THREATS ANTIMICROBIAL

2353
01:38:43,440 --> 01:38:49,160
THREATS THAT WE FACED. BACK TO

2354
01:38:49,160 --> 01:38:50,840
THE ORIGINAL SLIDE, WE ARE

2355
01:38:50,840 --> 01:38:53,560
THINKING FOUR TO SIX AWARDS

2356
01:38:53,560 --> 01:38:56,640
USING THE U 19 MECHANISM FOCUS

2357
01:38:56,640 --> 01:38:57,720
CANNING ON ANN MICROBIAL

2358
01:38:57,720 --> 01:39:06,040
RESISTANCE. 

2359
01:39:06,040 --> 01:39:10,680
>>QUESTIONS FROM COUNCIL

2360
01:39:10,680 --> 01:39:13,400
MEMBERS, DR. PALMER, YOU ARE

2361
01:39:13,400 --> 01:39:15,880
LINING UP ON THE SCREEN, I DON'T

2362
01:39:15,880 --> 01:39:17,040
KNOW IF YOU WANT TO SAY

2363
01:39:17,040 --> 01:39:22,760
SOMETHING. NO? OKAY.  DR.

2364
01:39:22,760 --> 01:39:23,880
JERNIGAN YOU HAVE YOUR HAND UP?

2365
01:39:23,880 --> 01:39:26,200
>>JUST HAPPY TO CONNECT
YOU IN

2366
01:39:26,200 --> 01:39:28,440
WITH THE DIVISION OF FOOD BORN

2367
01:39:28,440 --> 01:39:30,120
WATER BORNE AND ENVIRONMENTAL

2368
01:39:30,120 --> 01:39:33,880
INFECTIONS WITH REGARD TO

2369
01:39:33,880 --> 01:39:35,040
VIBRIO, (INAUDIBLE) REALLY

2370
01:39:35,040 --> 01:39:36,360
INCREASE BECAUSE OF THE

2371
01:39:36,360 --> 01:39:38,080
INCREASED TEMPERATURE OF WATER.

2372
01:39:38,080 --> 01:39:39,160
I DON'T BELIEVE THEY ARE

2373
01:39:39,160 --> 01:39:41,120
PLANNING TO ADD THAT TO THE AIM

2374
01:39:41,120 --> 01:39:43,760
OR LIST BUT HAPPY TO CONNECT

2375
01:39:43,760 --> 01:39:44,520
MICHAEL CRAIG AND OTHERS ON

2376
01:39:44,520 --> 01:39:45,000
THAT.

2377
01:39:45,000 --> 01:39:49,000
>>EXCELLENT. PROBABLY
WORTH

2378
01:39:49,000 --> 01:39:50,840
MENTIONING SINCE THERAPEUTICS,

2379
01:39:50,840 --> 01:39:53,400
WE ARE ACTIVELY SOLICITING GRAM

2380
01:39:53,400 --> 01:39:56,240
NEGATIVE FOCUS, SO ANYTHING THAT

2381
01:39:56,240 --> 01:39:58,480
COMES UP AS A THREAT THAT

2382
01:39:58,480 --> 01:40:01,840
EMERGES BETWEEN NOW AND THE NEXT

2383
01:40:01,840 --> 01:40:03,720
POTENTIAL DRUG WE COULD PUT THEM

2384
01:40:03,720 --> 01:40:04,840
INTO PRE-CLINICAL SERVICE

2385
01:40:04,840 --> 01:40:06,640
TESTING AND SEE HOW WHY THEIR

2386
01:40:06,640 --> 01:40:07,880
ACTIVITY WOULD BE EXPECTED TO BE

2387
01:40:07,880 --> 01:40:09,520
SO THERE IS LOT OF WAYS WE CAN

2388
01:40:09,520 --> 01:40:17,240
HANDLE THIS PROBLEM. THANK YOU,

2389
01:40:17,240 --> 01:40:27,800
JUDY.  I DIDN'T SEE HANDS GO UP.

2390
01:40:28,360 --> 01:40:31,080
>>SO WE CAN MAKE SURE ANY

2391
01:40:31,080 --> 01:40:32,240
QUESTIONS. 

2392
01:40:32,240 --> 01:40:34,600
>>WERE THERE ANY
QUESTIONS, ANY

2393
01:40:34,600 --> 01:40:35,520
FURTHER QUESTIONS FROM THE

2394
01:40:35,520 --> 01:40:37,840
COUNCIL MEMBERS WHO ARE ONLINE?

2395
01:40:37,840 --> 01:40:47,080
I DIDN'T SEE THE WHOLE GALLERY. 

2396
01:40:47,080 --> 01:40:52,240
DR. BOCKENSTEDT IS SHAKING HER

2397
01:40:52,240 --> 01:40:54,920
HEAD.  THANK YOU. NEXT IS DR.

2398
01:40:54,920 --> 01:40:56,840
REEDE SHABMAN, CONCEPT FOR

2399
01:40:56,840 --> 01:41:02,440
CLEARANCE FROM OD SET.

2400
01:41:02,440 --> 01:41:03,960
>>WHILE WAITING FOR
SLIDES TO

2401
01:41:03,960 --> 01:41:04,760
COME UP I WOULD LIKE TO THANK

2402
01:41:04,760 --> 01:41:05,680
YOU FOR THE OPPORTUNITY TO

2403
01:41:05,680 --> 01:41:09,240
PRESENT AND PRESENTING ON OFFICE

2404
01:41:09,240 --> 01:41:10,480
OF DATA SCIENCE EMERGING

2405
01:41:10,480 --> 01:41:12,640
TECHNOLOGIES AND DEPUTY DIRECTOR

2406
01:41:12,640 --> 01:41:17,560
ABOUT TEN MINUTES AGO. AND I WAS

2407
01:41:17,560 --> 01:41:23,760
IN DMID PREVIOUSLY, WORKING WITH

2408
01:41:23,760 --> 01:41:24,720
LILLIANA, HAVE AN OPPORTUNITY TO

2409
01:41:24,720 --> 01:41:26,040
PRESENT. TODAY I WANT TO TALK

2410
01:41:26,040 --> 01:41:27,840
WITH YOU SWITCH GEARS AN CHAT

2411
01:41:27,840 --> 01:41:32,480
WITH YOU BRIEFLY ABOUT FY 25

2412
01:41:32,480 --> 01:41:34,200
CONCEPT, CENTER OF EXCELLENCE

2413
01:41:34,200 --> 01:41:36,240
FOR SYSTEMS MODELING INFECTION

2414
01:41:36,240 --> 01:41:37,720
IMMUNITY ACROSS BIOLOGICAL

2415
01:41:37,720 --> 01:41:39,000
SCALES. AND THE OBJECTIVE OF

2416
01:41:39,000 --> 01:41:41,400
THIS CONCEPT IS TO ADVANCE

2417
01:41:41,400 --> 01:41:44,120
INFECTIOUS AND IMMUNE MEDIATED

2418
01:41:44,120 --> 01:41:45,560
DISEASE MODELING RESEARCH AND

2419
01:41:45,560 --> 01:41:47,520
COORDINATION AND WE WILL DO THIS

2420
01:41:47,520 --> 01:41:48,760
THROUGH RESEARCH PROJECTS AND

2421
01:41:48,760 --> 01:41:49,760
COORDINATION CORES SO THE

2422
01:41:49,760 --> 01:41:51,600
RESEARCH PROJECTS WILL IMPROVE

2423
01:41:51,600 --> 01:41:53,600
METHODS FOR MODELING COMPLEX

2424
01:41:53,600 --> 01:41:56,960
SYSTEMS RELATED TO INFECTIOUS

2425
01:41:56,960 --> 01:41:59,400
AND ALLERGIC AND IMMUNE MEDIATED

2426
01:41:59,400 --> 01:42:01,000
DISEASINGS ACROSS DIFFERENT

2427
01:42:01,000 --> 01:42:02,600
BIOLOGICAL SCALE SCALES. COORDIN

2428
01:42:02,600 --> 01:42:03,720
CORES WE WILL GET INTO MORE

2429
01:42:03,720 --> 01:42:05,640
DETAIL ON THE FOLLOWING SLIDES

2430
01:42:05,640 --> 01:42:07,360
WILL IMPROVE COLLABORATION

2431
01:42:07,360 --> 01:42:08,240
COORDINATION DATA MODEL SHARING

2432
01:42:08,240 --> 01:42:10,640
AND TRAINING AND ALIGN MODELING

2433
01:42:10,640 --> 01:42:12,000
WITH NIAID STRATEGIC PRIORITIES

2434
01:42:12,000 --> 01:42:16,320
SO THIS IS A U 54, THIS IS A NEW

2435
01:42:16,320 --> 01:42:17,680
CONCEPT FIVE YEARS, WE ARE

2436
01:42:17,680 --> 01:42:19,480
ANTICIPATING A SINGLE CENTER OF

2437
01:42:19,480 --> 01:42:21,360
EXCELLENCE OR COE. I WOULD LIKE

2438
01:42:21,360 --> 01:42:23,520
TO STOP HERE AND ACKNOWLEDGE I'M

2439
01:42:23,520 --> 01:42:25,440
PRESENTING ON A LARGE ON BEHALF

2440
01:42:25,440 --> 01:42:28,680
OF LARGE NUMBER OF FOLKS, ODSET

2441
01:42:28,680 --> 01:42:30,160
WHICH IS SITS IN THE OD.  THIS

2442
01:42:30,160 --> 01:42:33,800
IS JOINT INITIATIVE WITH DMID,

2443
01:42:33,800 --> 01:42:38,960
OVER HERE, SPEARHEAD AD LOT BY

2444
01:42:38,960 --> 01:42:41,240
(INAUDIBLE) BROWN, DADE ALLISON

2445
01:42:41,240 --> 01:42:43,360
CANDIDATES CARLY WILLIAMS, JASON

2446
01:42:43,360 --> 01:42:45,200
HEIGHT AND PETER KIM. THIS IS

2447
01:42:45,200 --> 01:42:48,280
GOING TO SPAN ALL THREE PROJECTS

2448
01:42:48,280 --> 01:42:52,320
ALL THREE DIVISIONS. SO LITTLE

2449
01:42:52,320 --> 01:42:54,080
BIT OF BACKGROUND. I WANT TO

2450
01:42:54,080 --> 01:42:55,880
TALK ABOUT SYSTEMS MODELING AND

2451
01:42:55,880 --> 01:42:57,600
HOW TO IMPROVE UNDERSTANDING OF

2452
01:42:57,600 --> 01:42:58,960
COMPLEX BIOLOGICAL MECHANISMS.

2453
01:42:58,960 --> 01:43:00,400
IN GENERAL A MODEL IS A

2454
01:43:00,400 --> 01:43:02,600
RECOMMENDATION OF REALITY

2455
01:43:02,600 --> 01:43:04,080
EXPRESSED THROUGH MATHEMATICAL

2456
01:43:04,080 --> 01:43:05,520
OR LOGICAL RELATIONSHIPS. THE

2457
01:43:05,520 --> 01:43:09,000
SYSTEMS MODEL IS A COMPUTATIONAL

2458
01:43:09,000 --> 01:43:09,760
MECHANISTIC RECOMMENDATION OF

2459
01:43:09,760 --> 01:43:11,160
COMPLEX PROCESS SUCH AS

2460
01:43:11,160 --> 01:43:12,360
INFECTION PROCESS ACROSS THE

2461
01:43:12,360 --> 01:43:13,800
CELL, T-CELL ACTIVATION AND

2462
01:43:13,800 --> 01:43:17,080
EPIDEMIC OR TRIAL.  SO THERE

2463
01:43:17,080 --> 01:43:18,440
COULD BE A LARGE NUMBER OF

2464
01:43:18,440 --> 01:43:21,200
EXAMPLES WE CAN SHOW ON THE

2465
01:43:21,200 --> 01:43:24,480
SLIDE IS A PAPER THAT DEFINE AS

2466
01:43:24,480 --> 01:43:26,120
PERIOD OF TIME BETWEEN MID

2467
01:43:26,120 --> 01:43:28,440
OCTOBER AND MID NOVEMBER OF 2019

2468
01:43:28,440 --> 01:43:30,040
AS PLAUSIBLE INTERVAL OF THE

2469
01:43:30,040 --> 01:43:33,160
FIRST CASE OF SARS COV-2 CASE IN

2470
01:43:33,160 --> 01:43:35,160
CHINA. BY CHARACTERIZING THE

2471
01:43:35,160 --> 01:43:36,360
DYNAMICS OF THE VIRUS BEFORE

2472
01:43:36,360 --> 01:43:37,960
DISCOVERY THE OFFICERS SHOWED

2473
01:43:37,960 --> 01:43:40,600
MORE THAN TWO-THIRDS OF SARS

2474
01:43:40,600 --> 01:43:45,240
COV-2 EVENTS SELF-LIMITED,

2475
01:43:45,240 --> 01:43:46,960
NEGATIVE PANDEMIC, DONE THROUGH

2476
01:43:46,960 --> 01:43:48,200
DATA STREAMS AND PUTTING INTO

2477
01:43:48,200 --> 01:43:49,760
THESE TYPES OF MODELS THIS IS

2478
01:43:49,760 --> 01:43:51,680
DISTINCT FROM USING A

2479
01:43:51,680 --> 01:43:55,320
COMPUTATIONAL MODEL EPIDEMIC

2480
01:43:55,320 --> 01:43:56,920
FORECASTING FOR EXAMPLE. A

2481
01:43:56,920 --> 01:43:59,960
LITTLE BACKGROUND, IT WOULD COME

2482
01:43:59,960 --> 01:44:01,880
NO SURPRISE FUNDING SIGNIFICANT

2483
01:44:01,880 --> 01:44:04,200
AMOUNT OF MODELING RESEARCH,

2484
01:44:04,200 --> 01:44:05,880
THAT RESEARCH WILL BENEFIT FROM

2485
01:44:05,880 --> 01:44:06,840
CORD NATION. SO WE LOOK AT DATA

2486
01:44:06,840 --> 01:44:10,920
A LOT OF WAYS AND I SAY THE WORD

2487
01:44:10,920 --> 01:44:12,000
NUMEROUS DEPENDING HOW YOU

2488
01:44:12,000 --> 01:44:13,920
ANALYZE YOU GET A LARGE NUMBER

2489
01:44:13,920 --> 01:44:16,520
BUT LARGE AWARDS MODELING

2490
01:44:16,520 --> 01:44:19,400
PROJECT, AS WE LOOK THROUGH FY

2491
01:44:19,400 --> 01:44:21,280
21 THROUGH 23, MANY ARE

2492
01:44:21,280 --> 01:44:23,840
INVESTIGATOR INITIATED. MOREOVER

2493
01:44:23,840 --> 01:44:26,880
30% MODELING IS AFFILIATE WITH

2494
01:44:26,880 --> 01:44:29,440
THE MIDAS NETWORK AND FUNDED BY

2495
01:44:29,440 --> 01:44:31,120
NIAID ANDLY SPEAK ABOUT THAT IN

2496
01:44:31,120 --> 01:44:32,880
A MOMENT. THERE IS LIMITED

2497
01:44:32,880 --> 01:44:34,080
COORDINATION TO SHARE METHODS

2498
01:44:34,080 --> 01:44:35,640
MODELS OR DATA ACROSS PATHOGENS

2499
01:44:35,640 --> 01:44:37,640
AND RESEARCHERS SO SOME EXAMPLES

2500
01:44:37,640 --> 01:44:39,840
OF THESE AWARDS IF YOU LOOK YOU

2501
01:44:39,840 --> 01:44:44,200
CAN SEE EXAMPLE OF MODELING HIV

2502
01:44:44,200 --> 01:44:46,680
RESERVOIR CANDIDATES MODELS HOST

2503
01:44:46,680 --> 01:44:52,160
MICROBIOTA, INTERACTION WITH --

2504
01:44:52,160 --> 01:44:53,720
AUTOMICROBIOME TRANSPLANTS AND D

2505
01:44:53,720 --> 01:44:56,040
MID AND MODELING TISSUE RESIDENT

2506
01:44:56,040 --> 01:45:02,680
T-CELLS IN DADES.  SPEAKING TO

2507
01:45:02,680 --> 01:45:04,920
IMPORTANCE OF HAVING A U 54,

2508
01:45:04,920 --> 01:45:05,920
COORDINATION WILL IMPROVE

2509
01:45:05,920 --> 01:45:06,960
COLLABORATION NEW METHODS AS

2510
01:45:06,960 --> 01:45:09,400
WOMEN AS DATA MODEL SHARING AND

2511
01:45:09,400 --> 01:45:12,280
REPRODUCIBILITY. SO THE GAO

2512
01:45:12,280 --> 01:45:15,240
CITED THE NEED FOR COORDINATING

2513
01:45:15,240 --> 01:45:17,120
INFECTIOUS IMMUNE MEDIATED

2514
01:45:17,120 --> 01:45:19,040
DISEASE MODELINGING. THIS IS WIY

2515
01:45:19,040 --> 01:45:21,520
RECOGNIZED IN 2020, PARAPHRASE

2516
01:45:21,520 --> 01:45:23,120
WHAT THIS REPORT FOUND IS

2517
01:45:23,120 --> 01:45:25,040
ESSENTIALLY THEY STATE MODELS IN

2518
01:45:25,040 --> 01:45:26,040
INFECTIOUS DISEASE GUIDE

2519
01:45:26,040 --> 01:45:27,840
DECISION MAKERS POLICIES FOR

2520
01:45:27,840 --> 01:45:28,960
DISEASE CONTROL AND MAY HELP TO

2521
01:45:28,960 --> 01:45:31,960
ALLOCATE RESOURCES. HHS AGENCIES

2522
01:45:31,960 --> 01:45:33,160
REPORTED USING MULTIPLE

2523
01:45:33,160 --> 01:45:34,480
MECHANISMS TO COORDINATE

2524
01:45:34,480 --> 01:45:36,960
MODELING EFFORTS ACROSS AGENCIES

2525
01:45:36,960 --> 01:45:38,880
BUT DO NOT EVALUATE EXTENT AND

2526
01:45:38,880 --> 01:45:41,120
SUCCESS OF COORDINATION.  SO

2527
01:45:41,120 --> 01:45:43,040
CONSEQUENTLY THE RISK MISSING

2528
01:45:43,040 --> 01:45:44,040
OPPORTUNITIES TO ADDRESS

2529
01:45:44,040 --> 01:45:46,640
MODELING CHALLENGES SUCH AS

2530
01:45:46,640 --> 01:45:49,120
COMMUNICATING CLEARLY, OBTAIN

2531
01:45:49,120 --> 01:45:52,640
ADEQUATE DATA AND RESOURCES

2532
01:45:52,640 --> 01:45:53,920
OUTBREAK AND DUPLICATION OF

2533
01:45:53,920 --> 01:45:55,440
AGENCY MODELING EFFORTS WHICH

2534
01:45:55,440 --> 01:45:57,600
LEAD TO INEFFICIENCIES. ON THE

2535
01:45:57,600 --> 01:46:00,040
RIGHT HAND SIDE IS PERSPECTIVES

2536
01:46:00,040 --> 01:46:01,600
IN SCIENCE CITED A NUMBER OF

2537
01:46:01,600 --> 01:46:05,840
TIMES DESCRIBING REPRODUCIBILITY

2538
01:46:05,840 --> 01:46:07,520
RESEARCH AND COMPUTATIONAL

2539
01:46:07,520 --> 01:46:09,000
SCIENCE. THE SCIENCE LED TO

2540
01:46:09,000 --> 01:46:10,040
EXCITING DEVELOPMENTS BUTNA

2541
01:46:10,040 --> 01:46:11,360
ITURE OF THE WORK IS EXPOSE

2542
01:46:11,360 --> 01:46:12,600
LIMITATIONS TO EVALUATE

2543
01:46:12,600 --> 01:46:15,680
PUBLISHED FINDINGS. SO IN OTHER

2544
01:46:15,680 --> 01:46:17,160
WORDS REPRODUCIBILITY HAS SERVED

2545
01:46:17,160 --> 01:46:20,160
AS MINIMUM STANDARD FOR JUDGING

2546
01:46:20,160 --> 01:46:21,600
SCIENTIFIC CLAIMS WHEN FULL

2547
01:46:21,600 --> 01:46:22,880
INDEPENDENT REPLICATION OF STUDY

2548
01:46:22,880 --> 01:46:24,680
IS NOT POSSIBLE SO WE CAN HAVE

2549
01:46:24,680 --> 01:46:27,200
REPRODUCIBILITY IN OUR MODEL MOS

2550
01:46:27,200 --> 01:46:29,720
WOULD BE A GOOD PLACE TO STRIVE.

2551
01:46:29,720 --> 01:46:31,280
HOW WOULD THIS -- WE START TO

2552
01:46:31,280 --> 01:46:33,760
ATTACK THESE CHALLENGES? THIS IS

2553
01:46:33,760 --> 01:46:36,160
HIGH LEVEL OVERVIEW HOW A SINGLE

2554
01:46:36,160 --> 01:46:37,800
CENTER OF CLEANSE COE SUPPORT

2555
01:46:37,800 --> 01:46:39,840
MULTIPLE PIs THROUGH EXPERTISE

2556
01:46:39,840 --> 01:46:40,880
AND MODELING RESEARCH AND

2557
01:46:40,880 --> 01:46:45,320
COORDINATION. SO ON THE LEFT IS

2558
01:46:45,320 --> 01:46:47,080
CURRENT STATES, MECHANISMS,

2559
01:46:47,080 --> 01:46:48,920
OBVIOUS WILL MORE, WE HAVE NIAID

2560
01:46:48,920 --> 01:46:51,000
SUPPORTED MODELING RESEARCH. IF

2561
01:46:51,000 --> 01:46:54,440
YOU GO ACROSS THE TOP, HERE YOU

2562
01:46:54,440 --> 01:46:57,160
SEE THIS COE WILL BE NIAID POINT

2563
01:46:57,160 --> 01:46:59,160
OF CONTACT IN RESOURCE FOR IAD

2564
01:46:59,160 --> 01:47:01,160
MODELING. THIS WOULD OCCUR

2565
01:47:01,160 --> 01:47:03,280
THROUGH CORES I MENTIONED.

2566
01:47:03,280 --> 01:47:04,720
CONSIDERING A MODEL OF DATA

2567
01:47:04,720 --> 01:47:06,560
SHARING CORE, COMMUNITY

2568
01:47:06,560 --> 01:47:08,440
DEVELOPMENT CORE, AS WELL AS

2569
01:47:08,440 --> 01:47:09,640
PLACE FOR OPPORTUNITY FUNDS.

2570
01:47:09,640 --> 01:47:10,840
THESE CORES ARE GOING TO ENGAGE

2571
01:47:10,840 --> 01:47:13,480
WITH THE RESEARCH COMMUNITY TO

2572
01:47:13,480 --> 01:47:15,640
HELP THESE INVESTIGATORS SPEAK

2573
01:47:15,640 --> 01:47:17,200
TO EACH OTHER ABOUT HOW THEY ARE

2574
01:47:17,200 --> 01:47:19,200
SHARING MODELS AND DATA AND

2575
01:47:19,200 --> 01:47:21,240
MAKING SILOED EFFORTS MORE

2576
01:47:21,240 --> 01:47:26,240
CONNECTED.  BUT COE GO BEYOND

2577
01:47:26,240 --> 01:47:27,560
COORDINATION, ALSO DRAW CUTTING

2578
01:47:27,560 --> 01:47:30,280
EDGE RESEARCH SO IN THE C 54

2579
01:47:30,280 --> 01:47:32,600
RESEARCH PROJECTS A COUPLE OF

2580
01:47:32,600 --> 01:47:34,600
REQUIRED PROJECTS AND OPTIONAL

2581
01:47:34,600 --> 01:47:36,440
PROJECT WHERE WE EXPECT CUTTING

2582
01:47:36,440 --> 01:47:37,520
EDGE TECHNOLOGIES AND MODELING

2583
01:47:37,520 --> 01:47:41,400
SPACE. ALL THIS TIE INTO THE

2584
01:47:41,400 --> 01:47:43,240
NIAID DATA ECOSYSTEM PORTAL ON

2585
01:47:43,240 --> 01:47:44,560
THE BOTTOM HERE, RECENTLY

2586
01:47:44,560 --> 01:47:46,840
LAUNCHED PORTAL THAT IS AN

2587
01:47:46,840 --> 01:47:48,640
AGGREGATOR OF DIGITAL ASSETS

2588
01:47:48,640 --> 01:47:51,120
FROM NIAID AND OTHERS SUPPORTED

2589
01:47:51,120 --> 01:47:54,280
INFECTIOUS DISEASE AND IMMUNE

2590
01:47:54,280 --> 01:47:57,560
MEDIATED DISEASE DATA. THIS IS A

2591
01:47:57,560 --> 01:47:59,320
LOT OF FEW BULLETS HERE BUT TRY

2592
01:47:59,320 --> 01:48:00,960
TO GO INTO MORE DETAIL WHAT THE

2593
01:48:00,960 --> 01:48:03,240
RESEARCH PROJECTS ENCOMPASS. SO

2594
01:48:03,240 --> 01:48:05,800
FOR EXAMPLE, THE RESEARCH

2595
01:48:05,800 --> 01:48:06,800
PROJECTS WOULD BRIDGE

2596
01:48:06,800 --> 01:48:08,040
COMPUTATIONAL MODELS AT

2597
01:48:08,040 --> 01:48:09,440
DIFFERENT BIOLOGICAL SCALES. FOR

2598
01:48:09,440 --> 01:48:11,360
EXAMPLE MOLECULAR AND CELLULAR

2599
01:48:11,360 --> 01:48:13,240
MODELS TO WITHIN HOST MODELS.

2600
01:48:13,240 --> 01:48:15,320
THEY CAN ALSO BRIDGE SCALES FROM

2601
01:48:15,320 --> 01:48:16,640
WITHIN HOST BETWEEN HOST MODELS

2602
01:48:16,640 --> 01:48:18,480
FOR PATHOGEN SPREAD FOR EXAMPLE.

2603
01:48:18,480 --> 01:48:20,280
THESE PROJECTS WOULD EVALUATE

2604
01:48:20,280 --> 01:48:21,520
HOW DETERMINANTS OF ONE SCALE

2605
01:48:21,520 --> 01:48:25,240
INFLUENCE OUTCOMES AT ANOTHER.

2606
01:48:25,240 --> 01:48:27,440
PROJECTS TO TRANSLATE FROM BASIC

2607
01:48:27,440 --> 01:48:29,840
SCIENCE POPULATION LEVEL

2608
01:48:29,840 --> 01:48:31,920
OUTCOME, THEY WOULD COVER

2609
01:48:31,920 --> 01:48:33,600
INFECTIOUS DISEASE ALLERGIC

2610
01:48:33,600 --> 01:48:35,160
MEDIATED DISEASE, IMMUNOLOGY,

2611
01:48:35,160 --> 01:48:36,440
HIV INCLUDED IN AT LEAST ONE

2612
01:48:36,440 --> 01:48:39,000
PROJECT SINCE THIS IS

2613
01:48:39,000 --> 01:48:40,600
COLLABORATION WITH DAID, IS.

2614
01:48:40,600 --> 01:48:42,760
DOESN'T HAVE TO BE THE ENTIRE

2615
01:48:42,760 --> 01:48:44,440
PROJECT. OF COURSE PRIORITIES

2616
01:48:44,440 --> 01:48:47,240
WITH CIRCLE AROUND AND NOT BE

2617
01:48:47,240 --> 01:48:50,280
LIMITED TO VACCINES AND

2618
01:48:50,280 --> 01:48:51,280
MICROBIALS, STRUCTURAL LEVEL

2619
01:48:51,280 --> 01:48:52,480
FACTORS WHICH ARE BECOMING MORE

2620
01:48:52,480 --> 01:48:54,680
IMPORTANT SUCH AS CLIMATE

2621
01:48:54,680 --> 01:48:56,920
CHANGE. TO REITERATE ON THE

2622
01:48:56,920 --> 01:48:59,520
COORDINATION CORE THERE IS IS

2623
01:48:59,520 --> 01:49:01,520
ADMINISTRATION ELEMENT, FROM

2624
01:49:01,520 --> 01:49:03,600
THIS U 54 AND WE EXPECT THESE

2625
01:49:03,600 --> 01:49:05,000
CORES TO DEVELOP INNOVATIVE

2626
01:49:05,000 --> 01:49:06,240
METHODS FOR DATA AN MODEL

2627
01:49:06,240 --> 01:49:08,680
SHARING THAT ENABLE REUSE. WHAT

2628
01:49:08,680 --> 01:49:10,200
MIGHT GO BEYOND TRADITIONAL WAYS

2629
01:49:10,200 --> 01:49:12,600
OF SHARING BESIDES PUTTING

2630
01:49:12,600 --> 01:49:17,760
SOMETHING ON GITHUB MAYBE LOOK

2631
01:49:17,760 --> 01:49:19,360
FOR SOMETHING MORE INNOVATIVE

2632
01:49:19,360 --> 01:49:21,240
AND FOSTER COMMUNITY THROUGH

2633
01:49:21,240 --> 01:49:22,880
WORKSHOPS AND OPPORTUNITY FUNDS.

2634
01:49:22,880 --> 01:49:25,080
VERY IMPORTANT IS THE COE SHOULD

2635
01:49:25,080 --> 01:49:26,880
BE ABLE TO PIVOT RESEARCH AND

2636
01:49:26,880 --> 01:49:28,360
COORDINATION DURING EPIDEMICS

2637
01:49:28,360 --> 01:49:29,640
AND PANDEMICS TO ALIGN WITH THE

2638
01:49:29,640 --> 01:49:34,320
PRIORITIES OF THE INSTITUTE. SO

2639
01:49:34,320 --> 01:49:37,760
THIS IS A SLIDE I'M PUTTING IN

2640
01:49:37,760 --> 01:49:40,880
WHICH IS RESPONSE TO SOME OF THE

2641
01:49:40,880 --> 01:49:43,080
COUNCIL FEEDBACK. I APPRECIATE

2642
01:49:43,080 --> 01:49:44,800
THAT, GET TO THAT ON THE NEXT

2643
01:49:44,800 --> 01:49:47,440
SLIDE, NIAID COE WILL SUPPORT

2644
01:49:47,440 --> 01:49:51,160
THE NIAID MISSION IN CONTEXT

2645
01:49:51,160 --> 01:49:51,640
SHOULD HAVE ACTIVITY AND

2646
01:49:51,640 --> 01:49:52,320
COMPLIMENT EXISTING PROGRAMS SO

2647
01:49:52,320 --> 01:49:53,280
THE POINT OF THIS SLIDE IS THAT

2648
01:49:53,280 --> 01:49:56,360
THERE ARE A LOT OF DIFFERENT

2649
01:49:56,360 --> 01:49:58,160
EFFORTS OUT THERE. HOWEVER WE DO

2650
01:49:58,160 --> 01:50:01,280
BELIEVE THE COE HAS UNIQUE PLACE

2651
01:50:01,280 --> 01:50:02,280
THAT SHOULD BE SUPPORTED. FOR

2652
01:50:02,280 --> 01:50:03,960
EXAMPLE WE SPENT A LOT OF TIME

2653
01:50:03,960 --> 01:50:06,240
TALKING THE INDIVIDUAL AWARDS IN

2654
01:50:06,240 --> 01:50:07,800
NIAID, RIGHT NOW WE THINK THEY

2655
01:50:07,800 --> 01:50:10,000
CAN BE ORGANIZED MORE

2656
01:50:10,000 --> 01:50:12,760
EFFICIENTLY.  THERE IS MIDAS

2657
01:50:12,760 --> 01:50:14,760
NETWORK, CONSISTING OF A SINGLE

2658
01:50:14,760 --> 01:50:16,000
U 24 WHICH IS PRIMARILY

2659
01:50:16,000 --> 01:50:18,280
COORDINATION CORES B, MOSTLY

2660
01:50:18,280 --> 01:50:21,920
FOCUSED ON COORDINATION AND NOT

2661
01:50:21,920 --> 01:50:23,400
NECESSARILY AS NIMBLE TO ALIGN

2662
01:50:23,400 --> 01:50:26,040
WITH THE NEEDS OF NIAID. THERE

2663
01:50:26,040 --> 01:50:27,760
IS THE INTERAGENCY MODELING AND

2664
01:50:27,760 --> 01:50:30,880
ANALYSIS GROUP. THIS IS A CROSS

2665
01:50:30,880 --> 01:50:32,640
NIH AND CROSS GOVERNMENT

2666
01:50:32,640 --> 01:50:35,160
ORGANIZATION WHICH CURRENTLY IS

2667
01:50:35,160 --> 01:50:37,480
IN SUPPORTED ANY ACTIVE AWARDS.

2668
01:50:37,480 --> 01:50:39,360
THERE ARE OTHER OUTSIDE OF

2669
01:50:39,360 --> 01:50:40,280
NIAID, THE CENTER FOR

2670
01:50:40,280 --> 01:50:41,440
FORECASTING AN OUTBREAK

2671
01:50:41,440 --> 01:50:44,240
ANALYTICS. THE DARPA ASKING

2672
01:50:44,240 --> 01:50:45,720
PROGRAM, LARGE IMPRESSIVE

2673
01:50:45,720 --> 01:50:48,840
PROGRAMS, FOCUSED ON

2674
01:50:48,840 --> 01:50:50,480
EPIDEMIOLOGY. THERE IS THE

2675
01:50:50,480 --> 01:50:53,400
ECOLOGY EVOLUTION OF INFECTIOUS

2676
01:50:53,400 --> 01:50:56,240
DISEASES WHICH NIAID WORKS WITH

2677
01:50:56,240 --> 01:50:58,480
AS WELL AS GATES FOUNDATION. SO

2678
01:50:58,480 --> 01:51:00,080
THESE EXIST AND WE BELIEVE THE

2679
01:51:00,080 --> 01:51:01,920
COE WILL COORDINATE WITH THESE

2680
01:51:01,920 --> 01:51:02,880
PROGRAMS BUT ALSO DISTINGUISH

2681
01:51:02,880 --> 01:51:04,680
ITSELF THROUGH SUPPORTING THE

2682
01:51:04,680 --> 01:51:05,800
NIAID MISSION THROUGH MODELS

2683
01:51:05,800 --> 01:51:08,680
THAT ARE GOING TO DIRECTLY

2684
01:51:08,680 --> 01:51:10,640
INFORM US ABOUT BETTER VACCINES

2685
01:51:10,640 --> 01:51:12,200
DIAGNOSTICS AND THERAPEUTICS.

2686
01:51:12,200 --> 01:51:16,520
AND ALSO BE ABLE TO PIVOT

2687
01:51:16,520 --> 01:51:17,760
TOWARDS THEIR INFRASTRUCTURE,

2688
01:51:17,760 --> 01:51:19,360
HOW INFRASTRUCTURE THAT CAN

2689
01:51:19,360 --> 01:51:20,960
PIVOT DURING EPIDEMICS AN

2690
01:51:20,960 --> 01:51:24,880
PANDEMICS.  SO ONE OTHER THING

2691
01:51:24,880 --> 01:51:28,040
TO POINT OUT HERE, IN OUR

2692
01:51:28,040 --> 01:51:29,480
OFFICE, AND OTHERS IS THIS

2693
01:51:29,480 --> 01:51:31,640
ACCOMPANYING NOCI. THE REASON WE

2694
01:51:31,640 --> 01:51:33,640
ARE APPOINTING NOCI HERE IS

2695
01:51:33,640 --> 01:51:35,920
SYSTEMS MODELING OF INFECTION

2696
01:51:35,920 --> 01:51:37,280
IMMUNITY ACROSS BIOLOGICAL

2697
01:51:37,280 --> 01:51:38,880
SCALES AND THE POINT IS TO

2698
01:51:38,880 --> 01:51:41,240
ENCOURAGE RO1 AND R21

2699
01:51:41,240 --> 01:51:42,240
APPLICATIONS FOR SYSTEMS

2700
01:51:42,240 --> 01:51:44,040
MODELING AND ENCOURAGE AWARDEES

2701
01:51:44,040 --> 01:51:46,040
TO COLLABORATE WITH THE COE.

2702
01:51:46,040 --> 01:51:47,400
AWARDEES ELIGIBLE FOR

2703
01:51:47,400 --> 01:51:49,760
OPPORTUNITY FUNDS IN COE JOIN

2704
01:51:49,760 --> 01:51:50,960
MEETINGS, WORKSHOPS ET CETERA. 

2705
01:51:50,960 --> 01:51:53,080
THIS IS PAY LINES, DEPEND HOW

2706
01:51:53,080 --> 01:51:55,120
WELL THEY DID IN REVIEW BUT IDEA

2707
01:51:55,120 --> 01:51:58,120
IS TO INCREASE THE NUMBER OF

2708
01:51:58,120 --> 01:51:59,640
INVESTIGATORS THAT WOULD BE

2709
01:51:59,640 --> 01:52:01,760
SUBMIT RESPONSIVE APPLICATIONS

2710
01:52:01,760 --> 01:52:05,320
TO INTERACT WITH THE COE. SO THE

2711
01:52:05,320 --> 01:52:06,440
COUNCIL FEEDBACK WE HAVE THE

2712
01:52:06,440 --> 01:52:08,200
OPPORTUNITY TO SPEAK WITH DR.

2713
01:52:08,200 --> 01:52:10,600
JERNIGAN AND PALMER AND GREAT

2714
01:52:10,600 --> 01:52:11,480
CONVERSATION WITH BOTH. THEY

2715
01:52:11,480 --> 01:52:15,760
WERE SUPPORTIVE OF THIS CONCEPT.

2716
01:52:15,760 --> 01:52:20,520
FEEDBACK INCLUDED TO FOCUS TO

2717
01:52:20,520 --> 01:52:23,160
MODEL IAD ACROSS BIOLOGICAL

2718
01:52:23,160 --> 01:52:24,960
SCALES REPRESENTS AN EXCITING

2719
01:52:24,960 --> 01:52:26,080
CHALLENGE IN THE FIELD.  ALSO

2720
01:52:26,080 --> 01:52:27,440
NOTESSED THE POTENTIAL SCOPE

2721
01:52:27,440 --> 01:52:29,360
ACROSS ALL SCALES IS LARGE. I

2722
01:52:29,360 --> 01:52:31,600
TEND TO AGREE WITH THAT. BUT IT

2723
01:52:31,600 --> 01:52:33,400
IS ALSO EXCITING CHALLENGE. THEY

2724
01:52:33,400 --> 01:52:35,000
THOUGHT MAYBE WE SHOULD CONSIDER

2725
01:52:35,000 --> 01:52:36,680
EMPHASIZING SPECIFIC SCALES OVER

2726
01:52:36,680 --> 01:52:37,960
OTHERS. IT IS ALSO IMPORTANT TO

2727
01:52:37,960 --> 01:52:40,000
CONSIDER HOW THE COE INTEGRATES

2728
01:52:40,000 --> 01:52:42,840
TO EXISTING MODELING PROGRAMS

2729
01:52:42,840 --> 01:52:44,560
AND THIS IS A IMPORTANT POINT,

2730
01:52:44,560 --> 01:52:46,120
WE DON'T WANT TO -- BASED ON

2731
01:52:46,120 --> 01:52:48,000
WHAT WE PRESENTED EARLIER DON'T

2732
01:52:48,000 --> 01:52:50,040
WANT TO REINVENT THE WHEEL, THIS

2733
01:52:50,040 --> 01:52:51,080
IS POSITIONED TO FIT INTO THE

2734
01:52:51,080 --> 01:52:55,120
LARGER ECOSYSTEM OF MORE

2735
01:52:55,120 --> 01:52:56,840
PROGRAMS ACROSS THE GOVERNMENT,

2736
01:52:56,840 --> 01:52:59,760
IMPORTANT TO ENCOURAGE JUNIOR

2737
01:52:59,760 --> 01:53:02,200
INVESTIGATORS EARLY STAGE

2738
01:53:02,200 --> 01:53:03,360
INVESTIGATORS SINCE TETANUS

2739
01:53:03,360 --> 01:53:05,760
SPACE IS COMPUTATIONAL AND A LOT

2740
01:53:05,760 --> 01:53:11,160
OF TIMES IS SITUATED IN THE MORE

2741
01:53:11,160 --> 01:53:16,520
JUNIOR FOLKS. FINAL SLIDE,

2742
01:53:16,520 --> 01:53:18,080
RELATED BUT LITTLE BIT ON THE

2743
01:53:18,080 --> 01:53:19,800
SIDE, THIS IS A HEADS UP FOR A

2744
01:53:19,800 --> 01:53:22,160
NOTICE OF SPECIAL INTEREST FOR

2745
01:53:22,160 --> 01:53:23,760
COMPETITIVE REVISION SUPPLEMENT

2746
01:53:23,760 --> 01:53:25,120
FOR COMPETITIVE REVISION

2747
01:53:25,120 --> 01:53:27,720
SUPPLEMENTS TO EXISTING T 32

2748
01:53:27,720 --> 01:53:29,160
PROGRAMS TO INCLUDE

2749
01:53:29,160 --> 01:53:30,480
INSTITUTIONAL RESEARCH TRAINING

2750
01:53:30,480 --> 01:53:33,160
AND DATA SCIENCE FOR INFECTIOUS

2751
01:53:33,160 --> 01:53:34,360
IMMUNE MEDIATE DISEASE. WE

2752
01:53:34,360 --> 01:53:37,000
WANTED TO INCLUDE THIS BECAUSE

2753
01:53:37,000 --> 01:53:44,400
THERE IS A NEED TO MEET -- TO

2754
01:53:44,400 --> 01:53:46,720
MEET THE GROWING NEED FOR IUD

2755
01:53:46,720 --> 01:53:48,560
RESEARCHERS WITH -- IID

2756
01:53:48,560 --> 01:53:50,680
RESEARCHERS WITH DATA SCIENCE

2757
01:53:50,680 --> 01:53:52,360
EXPERTISE NEEDS TO BE DONE BY

2758
01:53:52,360 --> 01:53:53,800
CREATING NEW SLOTS FOR

2759
01:53:53,800 --> 01:53:55,080
PRE-DOCTORAL TRAINEES IN

2760
01:53:55,080 --> 01:53:57,120
EXISTING T 32 PROGRAMS, THESE

2761
01:53:57,120 --> 01:53:58,240
TRAINING PROGRAMS WILL ESTABLISH

2762
01:53:58,240 --> 01:53:59,600
INSTITUTIONAL LEVEL

2763
01:53:59,600 --> 01:54:00,360
COLLABORATIONS BETWEEN

2764
01:54:00,360 --> 01:54:03,600
COMPUTATIONAL AND BIOMEDICAL

2765
01:54:03,600 --> 01:54:04,960
SCHOOLS FOR MULTI-DISCIPLINARY

2766
01:54:04,960 --> 01:54:06,280
COURSE WORK AN DISSERTATION

2767
01:54:06,280 --> 01:54:08,960
RESEARCH. THE IDEA HERE IS

2768
01:54:08,960 --> 01:54:10,760
ESSENTIALLY THAT YOU CAN CREATE

2769
01:54:10,760 --> 01:54:12,560
NEW COARSE WORK TO INCLUDE

2770
01:54:12,560 --> 01:54:13,480
NATURAL LANGUAGE PROCESSING

2771
01:54:13,480 --> 01:54:15,240
MACHINE LEARNING ARTIFICIAL

2772
01:54:15,240 --> 01:54:16,520
INTELLIGENCE FOR INDIVIDUALS

2773
01:54:16,520 --> 01:54:19,000
GETTING THEIR Ph.D.s SO THAT

2774
01:54:19,000 --> 01:54:21,040
THEY CAN START TO APPLY SKILL

2775
01:54:21,040 --> 01:54:22,520
SETS TO OTHER INFECTIOUS DISEASE

2776
01:54:22,520 --> 01:54:32,440
RESEARCH. I HOPE I WAS ABLE TO

2777
01:54:32,440 --> 01:54:34,560
SUMMARIZE A LOT OF DIFFERENT

2778
01:54:34,560 --> 01:54:35,720
EXCITING OPPORTUNITIES, COUPLE

2779
01:54:35,720 --> 01:54:37,360
OF EXCITING CONCEPTS GOING ON

2780
01:54:37,360 --> 01:54:38,880
HERE. I FINISHED WITH THE FINAL

2781
01:54:38,880 --> 01:54:43,200
SLIDE FOR THE U 54. I THINK I

2782
01:54:43,200 --> 01:54:44,760
WOULD BE HAPPY TO ADDRESS ANY

2783
01:54:44,760 --> 01:54:47,160
QUESTIONS YOU MAY HAVE. THANK

2784
01:54:47,160 --> 01:54:57,440
YOU VERY MUCH.

2785
01:54:58,480 --> 01:55:00,840
>>I WOULD TO POINT OUT
OFFICE O

2786
01:55:00,840 --> 01:55:07,920
DIRECTORS IS ONLINE AS WELL. 

2787
01:55:07,920 --> 01:55:14,160
>>THERE'S TWO PROJECTS
THAT

2788
01:55:14,160 --> 01:55:15,760
(INAUDIBLE) WONDERING THERE IS

2789
01:55:15,760 --> 01:55:18,480
QUITE A BIT OF (INAUDIBLE)

2790
01:55:18,480 --> 01:55:24,600
DEVELOP, WONDERING HOW EXAMPLES

2791
01:55:24,600 --> 01:55:31,120
OF ONE TYPE OF PROJECTS, FOR

2792
01:55:31,120 --> 01:55:34,520
WONDERING IF TWO PROJECTS MIGHT

2793
01:55:34,520 --> 01:55:39,080
BE CONSTRAINED IMAMMING DATA

2794
01:55:39,080 --> 01:55:42,120
ACCUMULATION, WHAT IS GOING TO

2795
01:55:42,120 --> 01:55:47,400
FIT, (INAUDIBLE) IN OTHER WORDS

2796
01:55:47,400 --> 01:55:51,000
WILL THE MODELING BE DEVELOP

2797
01:55:51,000 --> 01:55:58,440
DIVORCED FROM EXISTING DATA? 

2798
01:55:58,440 --> 01:56:02,680
(INAUDIBLE) THEN A LITTLE BIT

2799
01:56:02,680 --> 01:56:09,680
WONDERING ABOUT AND THINKING

2800
01:56:09,680 --> 01:56:12,840
VARIOUS GENERAL MODEL SYSTEMS,

2801
01:56:12,840 --> 01:56:14,960
IMAGE LIKE HOW DO YOU GUYS

2802
01:56:14,960 --> 01:56:15,280
(INAUDIBLE)

2803
01:56:15,280 --> 01:56:17,280
>>I SEE A LOT OF
POTENTIAL

2804
01:56:17,280 --> 01:56:19,040
HERE, I'M JUST WONDERING HOW

2805
01:56:19,040 --> 01:56:22,320
THEY CAN BE A BIT MORE FOCUSED.

2806
01:56:22,320 --> 01:56:25,120
>>REALLY GOOD POINTS
THERE. I

2807
01:56:25,120 --> 01:56:28,920
THINK HIGH LEVEL THIS IS A

2808
01:56:28,920 --> 01:56:30,360
SINGLE CENTER WITH COUPLE OF

2809
01:56:30,360 --> 01:56:32,600
RESEARCH PROJECTS SO WE EXPECT

2810
01:56:32,600 --> 01:56:36,480
EXPERTISE TO BE BROAD.  AND WE

2811
01:56:36,480 --> 01:56:37,960
WANT FOLKS WITH LOT OF DIFFERENT

2812
01:56:37,960 --> 01:56:39,640
AREAS. IF I UNDERSTAND YOUR

2813
01:56:39,640 --> 01:56:43,320
QUESTION CORRECTLY, WE WANTED

2814
01:56:43,320 --> 01:56:45,680
COMBINATION, SO WE WANT A

2815
01:56:45,680 --> 01:56:46,920
SITUATION WHERE PRIMARY FOCUS OF

2816
01:56:46,920 --> 01:56:51,280
THIS IS GOING TO BE INGESTION

2817
01:56:51,280 --> 01:56:54,680
AND MODELING OF EXISTING DATA.

2818
01:56:54,680 --> 01:56:56,440
WHERE GENERAL RATION NEW DATA

2819
01:56:56,440 --> 01:56:59,880
USED FOR VALIDATION.  AND WITH

2820
01:56:59,880 --> 01:57:04,200
RESPECT TO FOCUS, YOU CAN

2821
01:57:04,200 --> 01:57:06,400
ENVISION, THINKING LOUT WOULD

2822
01:57:06,400 --> 01:57:08,040
BUT ENVISION A SCENARIO ONE

2823
01:57:08,040 --> 01:57:09,840
PROJECT WOULD BE ON IMMUNE

2824
01:57:09,840 --> 01:57:11,880
MEDIATED FUNDING IMMUNE SYSTEM

2825
01:57:11,880 --> 01:57:14,360
DIGITAL TWIN FOR EXAMPLE HOW

2826
01:57:14,360 --> 01:57:18,320
THAT -- HOW THAT COULD BE

2827
01:57:18,320 --> 01:57:21,800
UNDERSTOOD IN THE CONTEXT OF A

2828
01:57:21,800 --> 01:57:24,920
PATHOGEN OR IMMUNE MEDIATED

2829
01:57:24,920 --> 01:57:26,040
DISEASE, POTENTIALLY ANOTHER

2830
01:57:26,040 --> 01:57:29,480
RESEARCH PROJECT ON A VIRUS OR

2831
01:57:29,480 --> 01:57:37,840
BACTERIA AND HOW IT CAN INTERACT

2832
01:57:37,840 --> 01:57:40,160
IN A HOST CELL IN A LARGE --

2833
01:57:40,160 --> 01:57:42,240
SORT OF BRIDGE THAT WITH A

2834
01:57:42,240 --> 01:57:46,760
LARGER SCALE SUCH AS ORGAN

2835
01:57:46,760 --> 01:57:49,920
SYSTEM OR BEYOND. IT IS A GOOD

2836
01:57:49,920 --> 01:57:51,960
QUESTION ABOUT SCOPE, BROUGHT UP

2837
01:57:51,960 --> 01:57:57,480
WITH COUNCIL MEMBERS AS WELL. IT

2838
01:57:57,480 --> 01:57:58,960
IS ALSO SOMETHING WE ARE

2839
01:57:58,960 --> 01:58:00,400
DISCUSSING INTERNALLY, I THINK

2840
01:58:00,400 --> 01:58:05,200
THAT IS WORTH MENTION.

2841
01:58:05,200 --> 01:58:06,640
>>DO YOU HAVE ANY OTHER

2842
01:58:06,640 --> 01:58:11,040
THOUGHTS ON THAT QUESTION?

2843
01:58:11,040 --> 01:58:13,560
>>NO, THANKS, REED.  YOU

2844
01:58:13,560 --> 01:58:16,480
ADDRESSED IT, IT IS A BIT OF

2845
01:58:16,480 --> 01:58:17,360
CHALLENGE BECAUSE THIS IS

2846
01:58:17,360 --> 01:58:18,640
TRANSNIAID INITIATIVE AND ALWAYS

2847
01:58:18,640 --> 01:58:22,280
THREE ARE PARTICIPATING SO WILL

2848
01:58:22,280 --> 01:58:23,360
BE REQUIRED IN THE SCOPE TO

2849
01:58:23,360 --> 01:58:25,600
ADDRESS HIV AND ASPECTS OF HIV

2850
01:58:25,600 --> 01:58:27,680
BECAUSE OF THE DATA INVOLVEMENT.

2851
01:58:27,680 --> 01:58:29,240
THEN BECAUSE THERE'S ALSO DATA

2852
01:58:29,240 --> 01:58:32,520
IN DMID, WE WILL PUT

2853
01:58:32,520 --> 01:58:33,520
REQUIREMENTS IN PLACE IN TERMS

2854
01:58:33,520 --> 01:58:35,760
OF WHAT TYPES OF BRIDGES NEED TO

2855
01:58:35,760 --> 01:58:38,720
BE BUILT BETWEEN GENOMIC SCALES

2856
01:58:38,720 --> 01:58:40,280
AND THEN HOLD THAT -- HOPE

2857
01:58:40,280 --> 01:58:41,760
INVESTIGATORS COME IN WITH

2858
01:58:41,760 --> 01:58:45,720
PROJECTS.  THAT WOULD FIT.  

2859
01:58:45,720 --> 01:58:47,760
CONSTRAINTS ARE HIGH LEVEL

2860
01:58:47,760 --> 01:58:48,600
BECAUSE BIG SCOPE IN THE

2861
01:58:48,600 --> 01:58:50,240
COMMUNITY RIGHT NOW WE TRYING TO

2862
01:58:50,240 --> 01:59:00,400
ADDRESS. 

2863
01:59:01,840 --> 01:59:05,000
>>DR. BOCKENSTEDT I SEE
YOUR

2864
01:59:05,000 --> 01:59:09,880
HAND IS UP. I SEE. DR. PALMER.

2865
01:59:09,880 --> 01:59:11,320
>>WE CAN BE
INTERCHANGEABLE

2866
01:59:11,320 --> 01:59:16,640
THAT IS OKAY. I WANT TO

2867
01:59:16,640 --> 01:59:18,640
EMPHASIZE WHAT IS UNIQUE IS

2868
01:59:18,640 --> 01:59:20,320
WORKING ACROSS SCALES SO I'M

2869
01:59:20,320 --> 01:59:23,240
TRYING TO THINK OF SPECIFIC

2870
01:59:23,240 --> 01:59:24,640
EXAMPLES, WE UNDERSTAND HOW

2871
01:59:24,640 --> 01:59:27,960
SUPER SHEDDERS FOR PATHOGEN THEN

2872
01:59:27,960 --> 01:59:29,440
AFFECT SPREAD THROUGHOUT A

2873
01:59:29,440 --> 01:59:31,800
COMMUNITY BUT LINKING THAT BACK

2874
01:59:31,800 --> 01:59:34,160
TO WHAT IS THE NETWORK AT THE

2875
01:59:34,160 --> 01:59:36,600
IMMUNE LEVEL WITHIN AN

2876
01:59:36,600 --> 01:59:38,080
INDIVIDUAL THAT CREATES THE

2877
01:59:38,080 --> 01:59:40,160
SUPER SPREADER AND THEN ALLOWS

2878
01:59:40,160 --> 01:59:41,600
SPREAD THROUGHOUT THE COMMUNITY

2879
01:59:41,600 --> 01:59:44,600
AND HOW EXTERNAL FACTORS OF THAT

2880
01:59:44,600 --> 01:59:46,000
COMMUNITY ALLOW THAT SUPER

2881
01:59:46,000 --> 01:59:48,880
SPREADING EVEN TO OCCUR. SO IT

2882
01:59:48,880 --> 01:59:51,040
IS REALLY POTENTIALLY VERY

2883
01:59:51,040 --> 01:59:52,520
IMPACTFUL, IT IS A BIG CHALLENGE

2884
01:59:52,520 --> 01:59:55,480
TO WORK ACROSS THOSE SCALES,

2885
01:59:55,480 --> 01:59:56,960
MOST DATA SCIENTISTS PREFER TO

2886
01:59:56,960 --> 02:00:00,120
WORK WITHIN ONE OF THOSE SILOS

2887
02:00:00,120 --> 02:00:02,200
BUT WHAT THIS DOES THAT IS

2888
02:00:02,200 --> 02:00:05,760
REALLY UNIQUE AND I FOUND QUITE

2889
02:00:05,760 --> 02:00:09,440
INNOVATIVE, WAS THE EMPHASIS ON

2890
02:00:09,440 --> 02:00:10,480
WORKING ACROSS DIFFERENT SCALES.

2891
02:00:10,480 --> 02:00:13,560
THAT IS WHAT STANDS OUT, WHY IT

2892
02:00:13,560 --> 02:00:18,680
IS NOT JUST ANOTHER DATA SCIENCE

2893
02:00:18,680 --> 02:00:21,040
PROGRPROGRAM. THIS HAS REALLY GT

2894
02:00:21,040 --> 02:00:23,160
THIS FOCUS ON MOVING ACROSS

2895
02:00:23,160 --> 02:00:25,840
SCALES WHICH COULD GIVE A LOT OF

2896
02:00:25,840 --> 02:00:30,320
INSIGHT TO WHY EMERGING

2897
02:00:30,320 --> 02:00:31,360
PATHOGENS RELATE -- BECOME

2898
02:00:31,360 --> 02:00:34,120
PANDEMICS AND OTHERS DIE OUT,

2899
02:00:34,120 --> 02:00:36,880
WHETHER THAT IS OCCURRING AT THE

2900
02:00:36,880 --> 02:00:37,720
INDIVIDUAL LEVEL SCALE,

2901
02:00:37,720 --> 02:00:39,960
COMMUNITY LEVEL SCALE OR THAT

2902
02:00:39,960 --> 02:00:41,320
INTERACTION BETWEEN THE TWO.

2903
02:00:41,320 --> 02:00:42,760
THAT IS WHAT THIS INITIATIVE

2904
02:00:42,760 --> 02:00:45,360
REALLY ADDRESSES.  I'M VERY

2905
02:00:45,360 --> 02:00:55,480
ENTHUSIASTIC ABOUT THIS. 

2906
02:00:55,480 --> 02:00:59,280
>>THANK Y THANK YOU. MORE
COMMR

2907
02:00:59,280 --> 02:01:00,560
QUESTIONS?

2908
02:01:00,560 --> 02:01:05,400
>>SO EVERYONE WHO IS A
COUNCIL

2909
02:01:05,400 --> 02:01:06,800
MEMBER PLEASE RECORD YOUR VOTES

2910
02:01:06,800 --> 02:01:08,280
ON EACH INDIVIDUAL CONCEPT IN

2911
02:01:08,280 --> 02:01:10,320
THE ELECTRONIC COUNCIL BOOK. IF

2912
02:01:10,320 --> 02:01:11,200
YOU FORGET PEOPLE WILL COME

2913
02:01:11,200 --> 02:01:17,080
AFTER YOU AND REMIND YOU.  BUT

2914
02:01:17,080 --> 02:01:20,560
THIS DOES CONCLUDE OUR OPEN

2915
02:01:20,560 --> 02:01:22,600
SESSION OF THE DMID SUB COUNCIL.

2916
02:01:22,600 --> 02:01:24,840
THANK YOU TO EVERYBODY AND WE

2917
02:01:24,840 --> 02:01:27,840
WILL RECONNECT VIRTUALLY IN

2918
02:01:27,840 --> 02:01:40,200
JANUARY. THANK YOU.