>> I WOULD LIKE TO INTRODUCE THE
SESSION CHAIR IS A COLLEAGUE OF
MINE ALSO FROM NIBIB.
>> OKAY.
>> THANK YOU, OUR FIRST SPEAKER
THIS MORNING IS DR. TATIANA
COHEN, SCIENTIFIC REVIEW OFFICER
FOR TECHNOLOGIES WHICH IS ONE OF
PREDOMINANT SYNTHETIC BIOLOGY
STUDY SESSIONS AND SHE'S HERE TO
ASSESS THE CRC REVIEW. MORNING
CAN YOU HEAR ME, MORNING AND
THANK YOU FOR INVITING ME TO
PARTICIPATE IN THIS MEETING AND
TELL YOU ABOUT NIH PEER REVIEW.
SO THE MISSION OF NIH IS TO
PROMOTE FUNDAMENTAL KNOWLEDGE OF
LIVING THINGS. AND TO USE THAT
KNOWLEDGE TO ADVANCE HEALTH.
AND SO THIS MISSION IS
ACCOMPLISHED THROUGH FUNDING
THAT'S OFFERED TO 27 NIH
INSTITUTES. MY -- OF THESE 27
INSTITUTES AND CENTERS THERE ARE
24 THAT ACTUALLY PROVIDE
FUNDING. SO THOSE ARE HERE. IN
BLUE. BUT THERE'S ALSO THREE
THAT DID NOT PROVIDE FUNDING BUT
ARE INVOLVED IN OTHER THINGS AND
SO ONE OF THESE IS THE CENTER
FOR SCIENTIFIC REVIEW. SO
THAT'S WHERE I'M FROM. SO THE
MEGS MISSION OF CSR CENTER FOR
SCIENTIFIC REVIEW IS TO INSHURE
AND WE ACCOMPLISH THROUGH THE
APPLICATIONS. WE REVIEW
ABOUT -- WE CONDUCT ABOUT 2,000
OF MEETINGS. TO THE THREE
CYCLES AND THIS REVIEW IS
ACCOMPLISHED THROUGH THE HELP OF
ABOUT 270 SCIENTIFIC REVIEW
OFFICERS. SUCH AS MYSELF. SO
THIS IS KIND OF A BREAKDOWN OF
THE TYPES OF APPLICATIONS THAT
WE REVIEW THE MAJORITY ARE WE
ARE FAMILIAR W. THESE ARE
TYPICAL FOUR OR FIVE YEAR GRANTS
250K BUDGET ANABOLIC. WE DO
ALSO REVIEW OTHER GRANT
MECHANISMS. SO OF THESE, A GRAY
PROPORTION IS RO 21, R 03 AND
TRAINING GRANTS WE ALSO REVIEW
FELLOWSHIP APPLICATION FOR
GRADUATE STUDENTS OR POSTDOCS
AND ALSO APPLICATIONS WE TALKED
THE OTHER DAY ABOUT THE
POSSIBILITY OF INVOLVING SMALLER
BUSINESSES. I WOULD LIKE TO
TALK TO YOU ABOUT IT AFTERWARDS
IF YOU WOULD LIKE. THERE'S A
LOT OF NICE OPPORTUNITIES THERE
FOR SMALL BUSINESS, SOMEWHERE
PHASE ONE APPLICATIONS, AND THE
COMMERCIALIZATION READINESS
PROGRAM. SO THIS IS THE TYPICAL
CYCLE FOR HOW THE REVIEW
MEETINGS ARE SET UP. THIS KIND
OF GIVES YOU A PERSPECTIVE ON
THE TIMELINES THAT ARE INVOLVED.
SO YOU CAN SEE A STTYPICAL CYCL
MIGHT TAKE A YEAR. FROM THE
ONSET OF WHEN THE APPLICATIONS
ARE FIRST RECEIVED AND ASSIGNED
TO SICIENTIICIENTIFIC REVIEW GR
AN OPPORTUNITY FOR THE REVIEWERS
TO BE ASSEMBLED INTO A PANEL TO
REVIEW THE APPLICATIONS.
TYPICALLY THAT TAKES SEVERAL
MONTHS. AND THEN ONCE WE ARE
DONE WITH THE REVIEW, THE TWO
PHASE NIH REVIEW ALLOWS FOR THE
NEXT PHASE TO COME IN SO WE ARE
PHASE ONE WHERE APPLICATIONS ARE
REVIEWED FOR SCIENTIFIC MERIT
AND THAT IS OUR ONLY JOB AND
AFTER THE REVIEW IT GOES ONTO
THE NIC WHERE THAT APPLICATION
AND ITS FORE IS THEN CONSIDERED
FOR FUNDING. SO WE DON'T HAVE
ANYTHING TO DO WITH FUNDING.
AND THEN TO BREAK THIS UP INTO
SORT OF WHERE THIS GOES, THE
FIRST PART OF THIS IS
APPLICATIONS COMING IN TO THE
DIVISION OF RECEIPT AND REFERRAL
SO THIS THE IS FIRST SORT OF SET
OF EYES THAT SEIZE THESE
APPLICATIONS. AND DETERMINES
HOW TO ASSIGN THE APPLICATION TO
THE IC, AND THEN MAKES INITIAL
DETERMINATIONS AS TO THE
SCIENTIFIC DISCIPLINE INTO WHICH
THIS APPLICATION MIGHT FALL
INTO. SO WHICH SCIENTIFIC GROUP
TO ASSIGN IT TO. THEN ONCE IT'S
ASSIGNED THEN THE SRO THEN
STARTS LOOKING OVER THE
APPLICATION AND MAKING A
DETERMINATION OF WHAT KIND OF
EXPERTISE IS NEEDED. IF IT'S A
STANDING PANEL A LARGE
PROPORTION OF THE REVIEWERS ARE
STANDING MEMBERS THAT ARE
NOMINATED AND ELECTED TO BE --
THEY USED TO BE CALLED PERMANENT
MEMBERS BUT THEY ACTUALLY SERVE
ANYWHERE BETWEEN 4-6 YEARS AND
THEY COME TO EVERY MEETING AND
ANOTHER SMALLER LESS THAN HALF
PROPORTION OF THEM WILL BE AD
HOCS, REVIEWERS THAT COME IN TO
PROVIDE ADDITIONAL EXPERTISE AND
FINISH THE REVIEW OF THE
APPLICATIONS. SO WE WILL ASSIGN
THESE APPLICATIONS. AND GIVE
THE REVIEWERS ABOUT TWO MONTHS
TO REVIEW THEN THE MEETING TAKES
PLACE OVER TWO DAYS AFTER WHICH
50% OF THE APPLICATIONS ARE
DISCUSSED SO WE NEVER DISCUSS
100% OF THE APPLICATIONS. THE
APPLICATIONS ARE SORTED FROM
BEST TO WORST AND THEN THE TOP
50% TYPICALLY ARE DISCUSSED.
AND THEN AFTER THAT DISCUSSION,
THEN THE SRO WRITES THE RESUME
AND THE SUMMARY OF DISCUSSION.
SO THE REVIEWERS PROVIDE THE
CRITIQUES, THEY PROVIDE THE
INDIVIDUAL CRITIQUES FOR EACH
APPLICATION AND THEN THE
DISCUSSION SUMMARY IS PROVIDE BY
THE SRO, AFTER THAT, THE
APPLICATION'S RELEASED TO THE --
OR THE SUMMARY STATE IS RELEASED
TO THE APPLICANT AND THE IC AND
THAT'S WHERE THE SECOND PHASE
OCCURS WHERE THE IC MAKES A
DETERMINATION BASED ON THEIR PAY
LINES OR OTHER CONSIDERATIONS.
LET'S BREAK THIS DOWN A LITTLE
BIT FURTHER SO THE DIVISION OF
RECEIPT AND REFERRAL, THIS
OFFICE DETERMINES WHETHER THE
APPLICATION IS ACTUALLY ELIGIBLE
FOR WHAT IT IS PROPOSING TO DO.
IF IT'S SUBMITTED TO A
PARTICULAR RFA OR A PARENT
ANNOUNCEMENT, WHETHER ALL OF THE
PARTS ARE IN PLACE SO THAT IT
CAN BE ACCEPTED AND AS I
MENTIONED JUST BEFORE, IT ALSO
MAKES THE DETERMINATION OF WHICH
IC THAT APPLICATION WILL BE
REFERRED TO. SOMETIMES THEY
RECOMMEND A PREFERRED IC THAT
MAY OR MAY NOT ALWAYS COINCIDE
WITH WHAT THAT MISSION IS AND SO
DRR WILL NEGOTIATE TO MAKE THE
DETERMINATION OF WHETHER THE
APPLICATION FALLS INTO THAT IC'S
PROBLEMATIC GOALS OR NOT.
SOMETIMES A SECOND IC MIGHT BE
ASSIGNED AS WELL IF THE FIRST IC
FOR EXAMPLE DECLINES OR IF AFTER
THE REVIEW, THERE IS A DECISION
MADE THAT FUNDING NEEDS TO BE
ALLOCATED DIFFERENTLY THAN A
SECONDARY IC MIGHT PLAY A ROLE
IN THAT CASE. AND THEN DRR ALSO
ASSIGNS, IS ONE OF THE INITIAL
ASSIGNMENTS TO THE SIDE REVIEW
GROUP. OUR GROUPS ARE ORGANIZED
INTO BRANCHES, AND DIVISIONS, SO
AFTER THAT DETERMINATION IS
MADE, THE APPLICATION THEN GOES
TO THE BRANCH WHEN IT IS FURTHER
CATEGORIZED. IF IT'S A
RESUBMISSION THEN IT'S LIKELY TO
JUST COME STRAIGHT TO THE STUDY
SECTION WHERE IT WAS FIRST
REVIEWED. SO THIS IS THE STUDY
SECTION THAT I RUN THIS HAS 23
STANDING REGULAR MEMBERS IF YOU
WILL. AND THEN AS I MENTIONED
THE REST ARE AD HOCS WE RECEIVE
ABOUT 80-90 APPLICATIONS PER
ROUND AND THAT'S APPEAR
IMPORTANT NUMBER TO KEEP IN MIND
IF YOU WANT TO THINK ABOUT HOW
YOUR APPLICATION WILL BE
EVALUATED AGAINST OTHERS. THERE
MIGHT BE OTHER APPLICATIONS THAT
ARE CONSIDERED AND IT MUST BE
RELATIVE. IT'S HOW IT'S RELATED
TO THE SCIENCE NOT TO LIST --
EACH OTHER.
WE HAVE THE SYSTEMS, LIVING CELL
DEVICES, ORGANOIDS, MICRO IF A
LITTIC DEVICE FOR SELF CULTURE,
PROBES FOR MOLECULAR PROCESSES,
SO FLUORESCENT PROBES, PARTICLE,
THINGS LIKE THAT. MUTUAL AND
METHODS FOR CELL ENGINEER SO
THIS IS RELEVANT FOR THIS
CONFERENCE TODAY. SO SYNTHETIC
BIOLOGY, AS WELL AS TOOLS FOR
MEASURING CELLULAR FUNCTION,
EXTRACELLULAR MANIPULATION AND
THINGS LIKE THAT. MICROFLUIDIC
TECHNOLOGIES. SO TECHNOLOGIES
AND DEVICES FOR CAPTURING AND
MANIPULATING CELLS, BIO
PRINTING, CELL SORTING, THINGS
LIKE THAT AND ALONG WITH CELL
ALSO EXTRACELLULAR VESICLES
WOULD FALL INTO THIS CATEGORY.
NEW METHODS AND TECHNIQUES FOR
PRESERVING CELLS THINGS LIKE BIO
REACTORS, CRYO BIOLOGY, BIO
STABILIZATION, BIO PRESERVATION
AND OTHER TYPES OF METHODS.
AND THEN DEVELOPMENT AND
ADVANCEMENT OF MICROSCOPY AND
HIGH RESOLUTION IMAGING SO
THINGS LIKE SUPER RESOLUTION
IMAGING TECHNIQUES, SOMETIMES
OCT, OTHER TYPES OF HIGH
RESOLUTION MICROSCOPY. THIS IS
KIND OF A GENERAL GUIDELINE
ALTHOUGH YOU CAN APPLY IT. SO
THE MAKEUP OF REVIEW PANELS,
SROS PUT A LOT OF THOUGHT INTO
THE MAKEUP OF THESE PANELS. SO
WE HAVE GENERAL GUIDELINES THAT
WE HAVE TO GO BY. SO FIRST OF
ALL, THE SCIENTISTS HAVE TO MEET
THE REQUIREMENTS OF THE PANEL.
THEY NEED TO MEET THE
REQUIREMENTS OF THE EXPERTISE.
THEY NEED TO BE VISIBLE
SCIENTISTS, SCIENTISTS THAT ARE
KNOWN IN THEIR AREA. AND THAT
CAN AT LEAST ON PAPER,
DEMONSTRATE THAT THEY HAVE THE
EXPERTISE NEEDED TO EVALUATE THE
APPLICATIONS. THE STUDY SECTION
ALSO HAVE TO BALANCE. WE HAVE
TO TAKE ALL KINDS OF DIVERSITY
INTO CONSIDERATION. WE DON'T
WANT REVIEWERS TO ALL BE IN THE
SAME CITY SO WE HAVE TO, YOU
KNOW, DISTRIBUTE THEM ACROSS THE
U.S. SO PUT A LOT OF THOUGHT
INTO THAT. OTHER TYPES OF
DIVERSITY LIKE DEMOGRAPHIC,
STATURE, YOU KNOW THE STATUS IN
YOUR CAREER, ALL OF THOSE ARE
IMPORTANT FOR US. YOU CAN, AT
ANY GIVEN MEETING, THERE'S A
LINK AND I HOPE THESE SLIDES
WILL BE AVAILABLE FOR PEOPLE.
BUT THERE'S A LINK THERE WHERE
YOU CAN ACTUALLY GO TO THE STUDY
SECTION DESCRIPTION AND SEE PAST
ROSTERS OF COURSE IF YOU APPLY
INTO THE STUDY SECTION APPLY FOR
THE MEETING. THE SUMMARY
STATEMENT ALSO LISTS THE ROSTER
OF THAT PARTICULAR MEETING. WE
PUT A LOT OF EFFORT INTO
TRAINING OUR REVIEWERS. SO
THESE REVIEWERS HAVE TO BE
TRAINED. NOT ONLY IN SORT OF
THE BASIC TENETS OF NIH REVIEW
AND HOW IMPORTANT IT IS TO
EVALUATE STRICTLY ON SCIENTIFIC
MERIT. BUT THEY'RE ALSO TRAINED
FOR WHAT WE CALL THE PILLARS OF
REVIEW SO PILLARS OF REVIEW ARE,
SO THINGS LIKE BIAS AWARENESS,
WE WANT TO MAKE SURE THAT THE
REVIEW IS FAIR AND UNBIASED AND
BIAS CAN BE MANY THINGS TO
DIFFERENT PEOPLE HERE.
INCLUDING THINGS LIKE, YOU KNOW,
BIAS AGAINST PARTICULAR
INVESTIGATORS OR TRANSLATIONAL
BIAS, DIFFERENT THINGS LIKE THAT
SO ALL REVIEWERS HAVE A MANDATED
TRAINING THAT THEY HAVE TO
UNDERGO EVERY THREE YEARS FOR
THAT. AND THEN ANOTHER OF THESE
PILLARS IS THE REVIEW INTEGRITY.
SO REVIEWERS HAVE TO UNDERSTAND
THAT INFORMATION THAT IS
PRESENTED IN THESE MEETINGS IS
PRIVILEGED AND CONFIDENTIAL IT
CANNOT BE DISCUSSED OUTSIDE THE
STUDY SECTION THAT EVERY PIECE
OF INFORMATION, EVERY PIECE OF
DOCUMENT THAT THEY RECEIVE CAN
ONLY BE DISCUSSED WITH THE GROUP
AND NOT ANYWHERE ELSE. AND THEY
HAVE TO PRESERVE THAT. THERE'S
ANOTHER MODULE THEY HAVE TO TAKE
TO HELP THEM GET TRAINED ABOUT
THAT. ALONG WITH TRAINING A
REGULAR PANEL, OUR REGULAR PANEL
MEMBERS. WE ALSO STRIVE TO
EXPAND THE POOL OF REVIEWERS.
SO WE DON'T WANT REVIEWERS WHO
HAVE BEEN, YOU KNOW, REVIEWING
FOR NIH FOR 30 YEARS AND
BASICALLY PRESENT UNDUE
INFLUENCE FOR THAT STUDY
SECTION. WE WANT TO MAKE SURE
THAT WE ARE ALWAYS TRAINING NEW
REVIEWERS AND THIS IS
ACCOMPLISHED THROUGH OUR EARLY
CAREER REVIEWER PROGRAM THIS IS
A PROGRAM THAT'S REALLY
WONDERFUL AND I WOULD HIGHLY
RECOMMEND IF YOU YOURSELF ARE AN
EARLY STAGE INVESTIGATOR OR IF
YOU KNOW COLLEAGUES WHO ARE
EARLY STAGE INVESTIGATORS AND
HAVE NOT PARTICIPATED ON A STUDY
SECTION YET IT'S A GREAT
EXPERIENCE. THE APPLICATION TO
THIS PROGRAM ESSENTIALLY JUST,
YOU KNOW, ONLY THE ELIGIBILITY
IS THAT THEY NEED TO BE ON ESI
WHO HAS APPLIED FOR A GRANT
APPLICATION, HAS RECEIVED THE
SUMMARY STATEMENT BACK, DOES NOT
HAVE AN RO 1 EQUIVALENT GRANT
AND HAS NOT SERVED ON A STUDY
SECTION YET THESE INDIVIDUALS
COME IN AND BASICALLY GET
TRAINED WHAT REVIEWERS ARE
LOOKING FOR. ASSIGNMENTS ARE
VERY LIGHT. THEY GET TWO
APPLICATIONS TO REVIEW. BUT
THEY -- BUT ASIDE FROM THAT THEY
PARTICIPATE FULLY THEY
PARTICIPATE IN THE ENTIRE TWO
DAYS, ARE HIGHLY ENCOURAGED TO
PARTICIPATE IN THE DISCUSSIONS,
PROVIDE THEIR OPINIONS AND IN
THE EVALUATION AND IT'S VERY
LIGHT, VERY DESIRABLE. SO HOW
IS YOUR APPLICATION EVALUATED?
WELL, FOR THIS -- IS A TYPICAL
REVIEW FOR AN RO 1 OR -- PROJECT
RESEARCH PROJECT GRANT, RPG. SO
THESE GRANTS HAVE FIVE REVIEW
CRITERIA. SIGNIFICANCE,
INVESTIGATORS, INNOVATION,
APPROACH AND ENVIRONMENT. THE
SUM OF THESE CRITERIA EQUALS THE
OVERALL IMPACT OF THE
EVALUATION. SO THE OVERALL
IMPACT AND KIND OF THE MAIN
THING THAT WE'RE LOOKING FOR IS,
AND I'M JUST GOING TO READ IT
HERE ASSESSMENT OF THE
LIKELIHOOD OF THE PROJECT TO
EXERT A SUSTAINED POWERFUL
INFLUENCE ON THE FIELD. SO
THAT'S REALLY THE SCIENTIFIC
MERIT THAT WE'RE LOOKING FOR IN
APPLICATIONS. NOW THESE REVIEW
CRITERIA ARE, SIGNIFICANCE IS
THE IMPORTANCE OF THE PROBLEM.
WHAT PROBLEM IS BEING SOUGHT AT
WITH THIS APPLICATION THAT IS
GOING TO BE SOLVED.
INVESTIGATORS SO DOES THE TEAM
HAVE THE NECESSARY EXPERTISE TO
REVIEW THE APPLICATIONS?
INNOVATION, SO HOW, WHAT IS THE
NOVELTY THAT IS BEING PROPOSED.
ARE THERE NEW METHODS OR TOOLS
THAT ARE BEING PROPOSED OR IS
THERE GOING TO BE AN INCREMENTAL
ADVANCE OR IS THERE GOING TO BE
KIND OF AN INTEGRATION OF
EXISTING METHODS OR TOOLS.
APPROACH, THAT'S A KEY CRITERION
IS THE RESEARCH PLAN WELL
OUTLINED? WHAT IS THE RIGOROUS
PRIOR RESEARCH THAT SUPPORTS
WHAT IS BEING PROPOSED? IS
THERE A RIGOROUS AND ROBUST
SCIENTIFIC METHOD THAT ENSURES
THAT THE RESEARCHERS HAVE
PLANNED OUT ALL OF THE
EXPERIMENTS AND ARE PLANNING TO
USE ROBUST STATISTICAL ANALYSES
FOR THE EVALUATION, FOR THE
ANALYSIS. AND THEN FINALLY
ENVIRONMENT. SO ARE THERE
RESOURCES AND FACILITIES THAT
ARE AVAILABLE TO THE TEAM?
THESE ARE ALL SCORED ON A SCALE
OF ONE THROUGH NINE. SCORE ONE
IS THE HEIGHT IMPACT SCORE.
SCORE NINE IS THE LOW IMPACT
SCORE. WE GENERALLY ENCOURAGE
REVIEWERS TO START AT FIVE.
WHICH WE CALL A WELL-BALANCED
APPLICATION WITH A BALANCE OF
STRENGTHS AND WEAKNESSES. AND
THEN AS THEY READ THEIR
APPLICATIONS, THEN EITHER MOVE
UP OR DOWN SO THEY CAN MAKE A
DETERMINATION. NOW ALL OF THESE
APPLICATIONS RECEIVE A SCORE.
SO DISCUSSED APPLICATIONS
RECEIVE AN AVERAGED OVERALL
IMPACT SCORE. OF -- FROM NOT
ONLY THOSE ASSIGNED APPLICATIONS
BUT ALSO THE ENTIRE PANEL. SO
THESE APPLICATIONS ARE GOING TO
BE DISCUSSED AND THEN THE ENTIRE
PANEL VOTES TO PROVIDE A SCORE
FOR THOSE APPLICATIONS AND THEN
THAT ULTIMATELY GETS PERCENTILED
DEPENDING ON WHAT THE GRANT
MECHANISM IS.
AND THEN THAT'S WHAT YOU GET IN
THE SUMMARY STATEMENT. IN
ADDITION TO THE SCORE THOSE
DISCUSSED APPLICATION ALSO GET A
RESUME AND SUMMARY OF DISCUSSION
ATCSR THOSE ARE ALL WRITTEN BY
THE SRO.
WE TRY TO SUMMARIZE WHAT THE
DISCUSSION WAS AND TRY TO
PROVIDE A LITTLE MORE GUIDANCE
AND WHAT THE REVIEWERS HAD IN
MIND, ESPECIALLY IF THE
EVALUATIONS ALSO INVOLVED THE
PANEL DISCUSSION WHICH IS VERY
IMPORTANT TO US. AND THEN THE
NON DISCUSSED APPLICATION
RECEIVE ONLY THE CRITERION
SCORES FROM THE THREE ASSIGNED
REVIEWERS THE SUMMARY STATEMENT
FOR NON DISCUSSED APPLICATIONS
ARE ONLY GOING TO HAVE THE THREE
CRITIQUES.
SO THIS IS REALLY IMPORTANT.
AND I HOPE THAT YOU NOT ONLY
HEAR THIS NOW BUT ALSO PROMOTE
THIS TO YOUR COLLEAGUES. THIS
FRAMEWORK IS GOING TO BE
CHANGED. STARTING FROM
APPLICATIONS THAT ARE DUE DATES
JANUARY 25, 2025, THE IMMEDIATE
EFFECT WILL BE ON RPG SO RO 1S,
R 23S, THERE IS A SIMILAR CHANGE
THAT'S GOING TO BE OCCURRING FOR
FELLOWSHIPS.WE DON'T REALLY HAVE
INFORMATION ABOUT SBI RS JUST
YET SO FOR NOW, LET'S FOCUS THIS
ON RPGS.
SO EVERYTHING I TOLD YOU IN THE
LAST SLIDE, IN TERMS OF THE
OVERALL IMPACT WILL REMAIN THE
SAME. SO THE OVERALL IMPACT
DOES NOT CHANGE, WE'RE STILL
LOOK FOR APPLICATIONS THAT HAVE
A HIGH AMOUNT OF SCIENTIFIC
MERIT BUT THE FIVE CRITERIA WILL
BE CONVERTED INTO THREE FACTORS.
SO, BASICALLY COMBINING SOME OF
THE CRITERIA AND ALSO AS APPEAR
EFFORT TO REDUCE BIAS TO TAKE
AWAY SOME OF THE ONGOING
POTENTIAL IMPLICIT BIAS THAT
COULD BE UNDULY -- UNDUE TO THE
INVESTIGATORS AND ENVIRONMENT.
SO RATHER THAN FIVE CRITERIA
THERE'LL BE THREE FACTORS THE
FIRST FACTOR IS THE IMPORTANCE
OF THE RESEARCH. THIS SEFKT
ESSENTIALLY COMBINES THE
SIGNIFICANCE AND THE INNOVATION.
SO HOW IMPORTANT IS THIS
PROBLEM? WHAT KIND OF ADVANCE
IS IT GOING TO MAKE AND IF YOU
WILL, IT ASKS THE QUESTION,
SHOULD THIS BE DONE? SO THIS IS
THE SCORING WILL REMAIN THE SAME
SO SCORE ONE THROUGH NINE. THE
NEXT FACTOR IS RIGOR AND
FEASIBILITY. SO THIS BASICALLY
TAKES THE APPROACH INCLUDING THE
SCIENTIFIC RIGOR AND REALLY ASKS
THE QUESTION, CAN IT BE DONE?
SO IT REALLY, IT ALSO INCLUDES
HUMAN SUBJECTS, CLINICAL TRIALS,
THINGS LIKE THAT. NOW THE THIRD
FACTOR, TAKES THE INVESTIGATOR
AND ENVIRONMENT, THIS IS NOT --
THIS WILL NOT BE SCORED. AND,
AGAIN, IN AN EFFORT TO TRY TO
REDUCE BIAS TO THE BEST OF OUR
ABILITY, THIS FACTOR WILL
EVALUATE WHETHER THERE IS
RELEVANT EXPERTISE AND WHETHER
THERE ARE RELEVANT RESOURCES.
SO INSTEAD OF, YOU KNOW, GOING
INTO GREAT DETAIL ABOUT CERTAIN
INVESTIGATORS OR, YOU KNOW, HOW,
YOU KNOW, HOW PRODUCTIVE THEY'VE
BEEN OR HOW ACCOMPLISHED THEY'VE
BEEN THIS WILL ONLY EVALUATE
WHETHER THERE'S PROPER EXPERTISE
AND IF NOT THE REVIEWERS WILL
HAVE AN OPPORTUNITY TO PROVIDE
WHAT EXPERTISE THEY BELIEVE WILL
BE STILL NECESSARY AND MISSING.
AND IT ALSO WILL EVALUATE THE
ENVIRONMENT SO, AGAIN, TO TRY TO
REDUCE BIAS AGAINST INSTITUTIONS
THAT ARE MORE HEAVILY RESOURCED
THAN OTHERS SO IT WILL ONLY
EVALUATE WHETHER THERE'S
ADEQUATE RESOURCES AND
FACILITIES IN THAT ENVIRONMENT.
AGAIN, THESE SLIDES, SO THIS HAS
BEEN AN ONGOING PROCESS, THERE
HAS BEEN A LOT OF COMMUNITY
OUTREACH TO TRY TO PROMOTE THE
UNDERSTANDING OF THIS REVISION.
I HAVE A LOT OF LENGTH HERE IF
YOU GET TO SEE THE SLIDES, I
REALLY ENCOURAGE YOU TO LOOK
INTO THEM. AND, ALSO TO PROMOTE
THEM TO YOUR COLLEAGUES. OKAY.
SO BACK TO STANDARD REVIEW FOR
NOW. SO AT THE MEETING, THE
APPLICATIONS AS I MENTIONED ARE
SORTED FROM -- BASED ON THEIR
SCORES PRIOR TO THE MEETING FROM
BEST TO WORST. THIS
DETERMINATION THE ORDER OF
REVIEW SO, WE DISCUSSED TOP 50%.
IMPORTANTLY, THE ENTIRE SLATE OF
THE APPLICATIONS IS NOT
CLUSTERED AS A WHOLE. IS NOT
SORTED AS A WHOLE BUT IN FACT IS
CLUSTERED BASED ON SPECIFIC
REQUIREMENTS. ONE OF THESE
REQUIREMENTS IS THE CAREER STAGE
WE ALWAYS CLUSTER EARLY STAGE
INVESTIGATORS HAVE ESTABLISHED
INVESTIGATORS AND THESE
INVESTIGATORS ARE EITHER
INVESTIGATORS WHO HAVE, ARE
STILL WITHIN THE TEN YEARS OF
THEIR TERMINAL DEGREE PH.D. OR
M.D. AND HAVE NOT SUCCESSFULLY
COMPLETED FOR AN RO 1-LIKE GRANT
OR NEW INVESTIGATORS SO A NEW
INVESTIGATOR IS EVEN PAST THAT
TEN YEAR LIMIT BUT STILL IS NOT
SUCCESSFUL IN -- SUCCESSFULLY
COMPUTED FOR NRPG SO THOSE ARE
CLUSTERED SEPARATELY R 21S ARE
ALSO CLUSTERED SUCCESSFULLY.
THESE ARE SMALL, RO 1-LIKE
GRANTS. THESE ARE THREES.
THESE ARE ONE TO TWO YEAR PERIOD
OF ABOUT 50,000 FOR THAT. WE
SOMETIMES REVIEW U 01 SO THESE
ARE BIOENGINEERING RESEARCH
PROJECTS. PARTNERSHIPS. AND IF
THERE'S ANY OTHER TYPE OF RFA
THAT REQUIRES CLUSTERING.
ANOTHER THING THAT WE CLUSTER IS
THE SO-CALLED CATS R 01 SO THIS
IS AN R 01 FOR EARLY STAGE
INVESTIGATORS IT HAS VERY
SPECIFIC REVIEW CRITERIA THAT I
ENCOURAGE YOU TO LOOK INTO IF
YOU KNOW ANYONE WHO IS A NEW
INVESTIGATOR AND AS I MENTIONED
SO THE NON DISCUSSED
APPLICATIONS, THAT FALL ON THAT
BOTTOM 50%, DOESN'T MEAN THAT
THEY'RE BAD APPLICATIONS THEY
JUST DIDN'T MEET THAT CUTOFF.
WHATEVER THAT CUTOFF WAS AND THE
CUTOFFS WILL BE DIFFERENT. NOW
THOSE APPLICATIONS CAN STILL BE
RECALLED BY ANYBODY AT THE
MEETING. SO IF, FOR EXAMPLE, IF
REVIEWERS HAD A VERY DISCREPANT
SCORE THAT MADE THAT APPLICATION
FALL TO THE BOTTOM OF THE 50%,
THAT -- ANY REVIEWER CAN
ACTUALLY RECALL THAT APPLICATION
AND ASK FOR IT TO BE REVIEWED
EVEN THOUGH IT WASN'T INITIALLY.
OKAY WELL, SO AFTER THAT MEETING
TAKES PLACE, THEN THE SCORES,
THE PRIORITY SCORES AND THE
FINAL -- THE FINAL SCORES AND
THE PERCENTILES FOR THAT MEETING
TYPICALLY GET RELEASED BETWEEN
24-72 HOURS TO THE APPLICANT SO
YOU CAN SEE RIGHT AWAY WHETHER
YOUR APPLICATION WAS DISCUSSED.
WHETHER IT WAS -- HOW WELL IT'S
SCORED YOU CAN START THINKING
ABOUT MAYBE NEXT STEPS. AND
THEN THE SUMMARY STATEMENT GETS
RELEASED WITHIN 30 DAYS. AS I
MENTIONED, WE TAKE A LOT OF TIME
INTO COMPRISING THE SUMMARY
STATEMENTS. I WRITE THE RESUME
AND SO THAT IS WHAT TAKES EXTRA
TIME. NOW ONCE THAT SUMMARY
STATEMENT IS RELEASED, THE SRO
IS NO LONGER THE POINT OF
CONTACT FOR DISCUSSING THAT
SUMMARY STATEMENT. ONLY A
PROGRAM IS. AND THE REASON FOR
THAT IS BECAUSE FIRST OF ALL
PROGRAM TYPICALLY LISTEN INTO
THE DISCUSSION SO THEY ARE
HIGHLY AWARE OF WHAT THINGS WERE
SAID DURING THE DISCUSSION.
ALTHOUGH TO A POINT BECAUSE
AGAIN, YOU KNOW, REMEMBER THOSE
DISCUSSIONS HAVE TO BE
CONFIDENTIAL. SO THE PROGRAM
CANNOT DISCLOSE TO YOU, FOR
EXAMPLE, WHO THE REVIEWERS WERE.
THEY CANNOT DISCLOSE TOO MANY
SPECIFICS ABOUT WHAT WAS SAID.
THAT'S STILL CONFIDENTIAL
INFORMATION. BUT CERTAINLY THEY
CAN HELP YOU MAKE THE
DETERMINATION OF, YOU KNOW, WHAT
GENERAL IDEA THERE WAS, YOU
KNOW, AND MAKE RECOMMENDATIONS
ABOUT WHAT TO DO WITH YOUR
APPLICATION NEXT. IS THIS AN
APPLICATION THAT'S GOING TO BE
FUNDED? IS THIS AN APPLICATION
THAT PERHAPS NEEDS TO BE
RESUBMITTED? YOU CAN RESUBMIT
APPLICATION AGAIN AND THAT CALLS
IT AN A 1. A RESUBMISSION HAS
AN ADDITIONAL REQUIREMENT FOR
THAT. AFTER -- IF THAT
APPLICATION IS UNSUCCESSFUL
AGAIN, YOU CAN GO AHEAD AND
RESUBMIT THAT APPLICATION A
THIRD TIME ALTHOUGH AT THIS
POINT IT WILL BE LIKE A NEW
APPLICATION AGAIN. YOU CAN
CONTINUE DOING THIS INDEFINITELY
UNTIL, WELL, HOPEFULLY YOUR
APPLICATION GETS FUNDED. OKAY
OTHER THINGS THAT MIGHT BE ON
THE STATEMENT. THERE'S
REQUIREMENT TO INCLUDE THINGS
LIKE THE RESOURCE SHARING PLAN.
THE BIOSKETCH HAS TO BE IN THE
CORRECT FORMAT. YOU HAVE TO BE
REALLY CAREFUL ABOUT
OVERSTUFFING SO THE RESEARCH
PLAN HAS A CERTAIN TEXT LIMIT.
YOU KNOW WLSHGS WHETHER IT'S
SIX PAGES OR TWELVE PAGES.
THERE'S RESPONSE REQUIREMENTS,
LINE REQUIREMENTS, IF YOU PUT
TOO MUCH THERE'S A CHANCE YOUR
APPLICATION MIGHT GET WITHDRAWN
DUE TO ELIGIBILITY SO PLEASE BE
REALLY CAREFUL WHEN YOU ARE
WRITING YOUR APPLICATIONS.
OKAY, SO WHO CAN ANSWER YOUR
QUESTIONS? SO BEFORE THE
APPLICATION IS SUBMITTED, PLEASE
REACH OUT TO YOUR PROGRAM
OFFICER BECAUSE THEY CAN
CERTAINLY HEAR OUT YOUR IDEA.
AND LET YOU KNOW HOW WELL IT
MIGHT FIT IN WITH THEIR
PROGRAMMATIC GUIDELINES. IS
THIS SOMETHING THAT THEY WOULD
REALLY WANT TO BE FUNDED? YOU
CAN CERTAINLY REACH OUT TO THE
SRO BUT THE SRO AT CSR AT LEAST
HAS LIMITATIONS ON WHAT I CAN
TELL YOU. I CAN GIVE YOU SOME
SUGGESTIONS ABOUT WHICH STUDY
SECTIONS YOUR APPLICATION MIGHT
FIT INTO ALTHOUGH EVEN IN THAT
CASE I CAN'T EVER GIVE YOU A
GUARANTEE AND THE REASON FOR
THAT IS WE NEED THE APPLICATION
TO BE COMPLETELY SUBMITTED
BECAUSE, YOU KNOW, WHAT YOU SAY
IN THE ABSTRACT OR SPECIFICS
MIGHT NOT BE WHAT IS IN THE
RESEARCH PLAN AND THIS HAS TO
FIT IN WITH THE SCIENTIFIC GOALS
YOU CAN CERTAINLY REACH OUT TO
RECEIPT AND REFERRAL. WITH
QUESTIONS. ABOUT MAKING
SUGGESTIONS. THE CSR WEBSITE
HAS A LOT OF INFORMATION ON IT.
REGARDING THE -- MAKING
DECISIONS ABOUT THE IC OR SOG.
SO WHICH IC AND WHICH SCIENTIFIC
REVIEW BRANCH. REVIEW MEETING
TO, SEND YOUR APPLICATION TO.
APPLICANTS CAN CERTAINLY MAKE A
RECOMMENDATION. YOU CAN PUT IT
IN THE COVER LETTER. THERE'S AN
AN ASSIGNMENT REQUEST FORM. YOU
CAN DO THAT BUT REALLY THE FINAL
DETERMINATION IS MADE AT THE
TIME OF RECEIPT. AFTER
SUBMITTING, YOU CAN REACH OUT TO
THE SRO IF, LET'S SAY, PERSON
YOU DON'T KNOW WHERE ELSE TO
TURN AND YOU NEED SOME GUIDANCE
AND LET'S SAY YOU WANT YOUR
APPLICATION TO GO TO A
PARTICULAR IC AND YOU SEE IT
WENT SOMEPLACE ELSE. YOU HAVE
QUESTIONS ABOUT THAT, I CAN
CERTAINLY NAVIGATE YOU TO THE
RIGHT PEOPLE FOR THAT IF YOU
HAVE, IF YOU DISAGREE WITH THE
ASSIGNMENT OF THE STUDY SECTION,
YOU CAN REACH OUT TO THE SRO AND
WE CAN SEE WHAT WE CAN DO BUT
AGAIN THE APPLICATION, YOU KNOW,
GETS REVIEWED IN THE GROUP THAT
BEST FITS THE SCIENCE OF THE
APPLICATION. THAT IS REALLY
KIND OF WHAT DETERMINES IT. A
LOT OF TIMES APPLICANTS WILL
REACH OUT TO US AND SAY THE
APPLICATION WAS REVIEWED IN YOUR
MEETING. IT DID REALLY POORLY.
I WANTED TO GO TO A DIFFERENT
MEETING. THAT'S NOT
UNFORTUNATELY A CRITERION FOR US
AND AFTER REVIEW AS I MENTIONED
THE ASSIGNED PL THAT'S INDICATED
ON THE UPPER LEFT CORNER OF THE
STATEMENT. SO FINALLY, IF YOU
HAVE ANY CONCERNS REGARDING THE
OUTCOME OF YOUR REVIEW, WE HAVE
CHANNELS THAT YOU CAN SUBMIT
YOUR CONCERNS TO. IN
PARTICULAR, YOU HAVE ANY
CONCERNS ABOUT BIAS, OR ANYTHING
ELSE THAT YOU FEEL BASICALLY
COLORED THE FAIRNESS OF YOUR
REVIEW THE PLACE TO REACH OUT
FOR, OF COURSE YOU CAN ALWAYS
REACH OUT TO THE SRO BUT WE DO
HAVE CSR DOES HAVE CHANNELS THAT
ARE SPECIFIC TO REPORTING BIAS.
THERE'S THE E-MAIL THERE. AND
IN THE EVENT THAT YOUR
APPLICATION, OR YOUR SUMMARY
STATEMENT DOES INDICATE SOME
SORT OF BIAS, YOUR APPLICATION
WILL BE RE-REVIEWED WITHIN THE
SAME CYCLE. SO BEFORE THE IT
COMES DOWN TO THAT AND IF YOU
HAVE QUESTIONS AROUND THE REVIEW
INTEGRITY THERE'S ALSO A
SEPARATE CHANNEL FOR THAT. SO
THAT'S EVERYTHING THAT I HAVE.
AND I AM WELCOMING ANY OF YOUR
QUESTIONS.
>> DOES ANYONE HAVE QUESTIONS
FOR DR. COHEN? CAN YOU COME UP
TO THE MICROPHONE?
>> AUDIENCE: I WANT TO SPEAK IF
FOR YOUNG PEOPLE, NOT MANY YOUNG
PEOPLE HERE BUT AT LEAST FOR
HIM. SO I'M TOO SENIOR NOW. I
KNOW, IN THE ENTIRE PROCESS,
UNDERSTANDING THEN, THE ONE
THING I AM GOING TO ASK IS, THIS
IS MY FEELING SO IT MIGHT BE
TRUE OR NOT BE TRUE BUT I ALSO
TALK TO MY COLLEAGUE ABOUT THE
REVIEW PROCESS. THERE USED TO
BE MULTIPLE THING, SIGNIFICANCE
APPROACH, ET CETERA, UP UNTIL
NOW WHAT I FELT WAS CALLING
BECAUSE OF THE SCORE. THE
IMPACT SCORE WAS DETERMINED BY
THE APPROACH AND I WANT TO KNOW
IF THAT'S TRUE OR NOT. THE
SECOND QUESTION IS OVER BIAS. I
WELCOME THE NEW CHANGE.
POTENTIALLY HAVE ALREADY AT THE
END OF THE DAY, I'M A JUNIOR AND
I'M SUCCESSFUL FOR OTHER FUNDING
BUT NIH WHEN I WAS VERY JUNIOR I
NOT VERY MUCH HAVE SUCCESS AND
AFTER THAT I LIMIT MY SUBMISSION
BECAUSE I FEEL LIKE THIS IS NOT
MY COMMUNITY, THIS IS MORE THE
SCIENCE COMMUNITY OR THE
ADAPTERS COMMUNITY. SO THE
SECOND QUESTION IS I HOPE THIS
WILL CHANGE THE, WHATEVER BIAS
KIND OF PROBLEM IN THE STUDY
SECTION. BUT IS IT REALLY?
KIND OF TREMENDOUSLY KIND OF
CHANGED THE CULTURE OR YOU
EXPECTING SLOW STEP BY STEP
CHANGE IN THE FUTURE? I WANT TO
SPEAK FOR HIM BECAUSE HE
PROBABLY CANNOT ASK THAT KIND OF
QUESTION BECAUSE HE'S TOO JU
JUNIOR.
>> I'M GLAD YOU ASKED THAT
QUESTION. BOTH OF THOSE ARE
REALLY GOOD QUESTIONS. LET ME
TAKE THE FIRST ONE FIRST. SO
THE PURPOSE OF THE REVIEW IS TO
EVALUATE FOR SCIENTIFIC MERITS
WHICH IS THE SIGNIFICANCE. AND
THE OVERALL IMPACT. THIS IS
WHAT WE TRAIN OUR REVIEWERS TO
DO. NOW HOW WELL THE REVIEWERS
MIGHT COMPLY WITH THAT, IT COULD
VARY. WE HOPE THAT WE ARE DOING
BETTER. WE HOPE THAT WE ARE
CONTINUING TO DO BETTER. BUT
THE APPROACH IS IMPORTANT. YES,
BUT WE REALLY STRIVE TO
ENCOURAGE THE REVIEWERS TO THINK
ABOUT THE IMPORTANCE OF THE
PROBLEM. SOMETIMES THE APPROACH
CAN BE FIXED CERTAINLY IN
RESUBMISSIONS, YOU KNOW, IF
THERE ARE SOME WEAKNESSES IN THE
APPROACH THAT'S ALL DOABLE WHAT
CAN'T BE FIXED IS THE
SIGNIFICANCE SO IF THE PROBLEM
IS SIMPLY NOT LARGE ENOUGH TO
MAKE AN ADVANCE, NOT IMPORTANT
ENOUGH TO MAKE AN IMPORTANT
ADVANCE ON THE FIELD, THERE'S
NOT A WHOLE LOT THAT CAN BE DONE
WITH THAT PROJECT. SO THAT'S
WHAT WE -- THAT'S HOW WE TRAIN
OUR REVIEWERS, THAT'S WHAT WE
EXPECT TO DO THEM AND, BUT
REVIEWERS AS HUMANS MIGHT PICK
THINGS UP AT DIFFERENT LEVELS
BUT THAT'S CERTAINLY HOW I TRAIN
MY REVIEWERS AND I EXPECT THEM
TO UPHOLD THAT TYPE OF STANDARD
SO FOR THE SECOND QUESTION, SRF,
YEAH, WE ARE -- WE HAVE HIGH
HOPES THAT THIS IS GOING TO
REALLY CHANGE THE CULTURE OF
REVIEW. WE ARE AWARE THAT NIH
HAS BEEN STRUGGLING WITH BIAS
FOR MANY YEARS. WE STARTED OFF
TO ADDRESS THIS BIAS THROUGH THE
TRAININGS THAT WE DEVELOPED.
AND WE DIDN'T THINK THAT IT WENT
FAR ENOUGH AND SO WE WENT TO THE
COMMUNITY TO ASK WHAT THE
COMMUNITY WOULD LIKE TO DO. AND
SO THE COMMUNITY REALLY CAME UP
WITH THESE -- WITH THIS
SIMPLIFIED REVIEW FRAMEWORK THAT
REALLY SEGREGATES BIAS INTO A
NON SCORED CATEGORY. NOW,
REGARDING JUNIOR, I DON'T THINK
THE WORD JUNIOR, EARLY STAGE
INVESTIGATORS, YOU KNOW, AS I
MENTIONED, THOSE APPLICATIONS DO
GET CLUSTERED. THEY DO HAVE A
DIFFERENT PERCENTILING SYSTEM I
KNOW INSTITUTES DO THE TWO
THINGS DIFFERENTLY.
WHATEVER THE PERCENTILE IS, SO,
SOME OF THIS IS OUTSIDE THE, YOU
KNOW, WHAT I CAN EXPLAIN AS AN
SRO BECAUSE MY ROLE IS TRAINING
REVIEWERS MY ROLE IS NOT RELATED
TO FUNDING ON ANY LEVEL SO WE
REALLY KEEP THOSE VERY SEPARATE
BUT AS FAR AS TRAINING THE
REVIEWERS AND ENSURING THAT THEY
TAKE INTO ACCOUNT THAT AN EARLY
STAGE INVESTIGATOR IS, YOU KNOW,
NOT GOING TO HAVE, YOU KNOW, THE
SAME RECORD OF ACCOMPLISHMENT,
IS NOT GOING TO HAVE THE SAME
STATURE IN THE FIELD IS VERY
IMPORTANT AND THIS IS, AGAIN,
WHAT FEEDS INTO THE REASON WHY
FACTOR THREE WAS CREATED. SO
THAT INSTEAD OF IN THE PAST
THERE WAS THE STATURE OF THE
INVESTIGATOR. THE REVIEWERS
WOULD SAY I KNOW THIS PERSON AND
I KNOW THAT THEY ARE, YOU KNOW,
VERY IMPORTANT IN THE FIELD VERY
RENOWNED. SO REGARDLESS OF WHAT
THE APPLICATION IS, THEY KNOW
WHAT THEY'RE DOING. SO STARTED
ADDRESSING THIS THREE YEARS AGO
WITH THE BASE TRAINING. WE
THINK WE ARE DOING BETTER. WE
DO GET RESOLUTION OF CASES.
WHERE PEOPLE, YOU KNOW, COME
BACK TO US WITH QUESTIONS WELL,
YOU KNOW I THINK THE REVIEW WAS
BIASED AND WELL WHEN WAS THE
REVIEW DONE? IT WAS DONE THREE
YEARS AGO. OKAY, SO WE'RE
TAKING DIFFERENT STEPS TO
ADDRESS THIS. AND THE HOPE IS
THAT SRF WILL ALLOW US TO
CONTINUE TO DOWNPLAY THESE KIND
OF BIASES EVEN FURTHER.
>> AUDIENCE: I SEE, DO -- SO I
CAN -- GIVE TWO COMMENTS? I
ASKED THE QUESTION BASED ON MY
VERY LIMITED NUMBER OF
SUBMISSION. THE -- I KIND OF
LOOK AT THE SCORE AND THE FINAL
IMPACT SCORE AND SOMEHOW AN
APPROACH CAN CORRELATE WITH THAT
ONE AND THEN I GOT THE OTHER
ONE, THE OTHER ONE IS VERY
HEAVILY APPROACHED IN DEEP CARE
AND SOMEHOW THE RECENT ONE NOT
DISCUSSED WE DIDN'T DO THAT MUCH
DETAIL, NO APPROACH DESCRIPTION
AND THEN WE ARE NOT DISCUSSED
EVEN THOUGH I THOUGHT I FELT
THAT PROPOSES THE BEST IDEA I
EVER, YOU KNOW, IMAGINED. SO
THAT IS BECAUSE OF THAT, AND I
KIND OF HAVE THAT COMMENT OR THE
QUESTION. THE SECOND ONE IS
ABOUT THE EARLY CAREER, YOU
KNOW, DEBUT PANEL VULNERABILITY.
I ACTUALLY WAS SELECTED AND I
HOPE THAT IS CHANGING IN THE
FUTURE. IF YOU NEED SOME NAMES
I CAN GIVE 200 NAMES FOR YOU.
AND I'M HAPPY TO PROVIDE THEM.
>> THANK YOU FOR THAT THE ECR
PROGRAM WAS ACTUALLY REVISED
SEVERAL YEARS AGO SO WE USED TO
HAVE THE REQUIREMENT WAS TO
INCLUDE AN ECR ON ONE ECR ON
EVERY STANDING PANEL. THE --
AND THEY WOULD REVIEW ACTUALLY
FOUR APPLICATIONS. NOW THE
REQUIREMENT IS TWO ECRS SO WE
CAN ACTUALLY GET MORE PEOPLE
TRAINED TO UNDERSTAND WHAT IS
INVOLVED IN THE REVIEW. AND AS
I MENTIONED, IT'S REALLY A GREAT
PROGRAM SO PLEASE APPLY ONLINE,
THE APPLICATION PROCESS IS VERY
QUICK. YOU CAN, YOU KNOW, IF
YOU ARE ELIGIBLE YOU CAN GET
TURNED AROUND IN 24 HOURS. AND
THEN IT'S A -- SOME ECRS ARE
SELECTED DIRECTLY BY SROS AND
THIS IS A GENERAL COMMENT TO
COMMUNITY. WHATEVER QUESTIONS
YOU MAY HAVE ABOUT KIND OF THE
MYSTERY, RIGHT, LIKE THE BLACK
BOX OF NIH I HIGHLY ENCOURAGE
YOU TO SERVE AS A PANEL MEMBER.
IF YOU'RE INVITED AND ELECTED TO
COME AS A STANDING MEMBER THE
MYSTERY GETS RESOLVED. YOU SEE
THE APPLICATIONS THAT ARE
REVIEWED. SOMETIMES, YOU KNOW
THE APPLICANT MIGHT THINK IT'S
THE BEST IDEA THEY'VE HAD BUT LO
AND BEHOLD THERE ARE FIVE OTHER
APPLICATIONS THAT POSE A SIMILAR
IDEA IN THE SAME STUDY SECTION
AND SO ANOTHER THING TO POINT
OUT IS, YOU KNOW, YOU MIGHT END
UP IN A SITUATION WHERE YOU
APPLY YOUR FIRST INITIAL
SUBMISSION GETS A PARTICULAR
SCORE IS DISCUSSED, YOU RESUBMIT
AND THAT APPLICATION IS NO
LONGER DISCUSSED. THAT CAN
HAPPEN. AND THE REASON FOR
THAT, WELL, TWO, IS THE FIRST
REASON IS DEPENDING ON HOW THE
APPLICATION SCORING TOOK PLACE.
WHAT TYPE OF SCORING THEY
RECEIVED THAT DETERMINES THE 50%
CUTOFF. IN ONE ROUND LET'S SAY
AN R 01 ESTABLISHED
INVESTIGATORS MIGHT HAVE A
CUTOFF OF 4.0. IN ANOTHER ROUND
THAT MIGHT BE 3.7 IT DOESN'T
MEAN THE APPLICATION IS WORSE OR
YOU KNOW WHY WASN'T IT
DISCUSSED? IT DOESN'T MEAN IT'S
BAD IT'S JUST THAT IT DIDN'T
MAKE IT UNFORTUNATELY TO THAT
TOP 50%. AND SO BY SERVING AS A
REVIEWER YOU REALLY KIND OF, YOU
KNOW, DELVE INTO THE MYSTERY OF
THESE. S
>> AUDIENCE: I'M AN OFFICER ON
THE OTHER SIDE OF REVIEW. SO WE
OFTEN ENCOUNTER A SITUATION
WHERE PI'S ARE JUST MAD IN THE
SUMMARY STATEMENT. SO, YOU
KNOW, BELIEVE IT OR NOT I ALWAYS
TELL PEOPLE DON'T CALL ME IF YOU
ARE NOT DISGUST ENOUGH TO KNOW
AFTER READING THE SUMMARY AT THE
SAME TIME BUT SOMETIMES THEY'RE
RIGHT. FOR EXAMPLE, IF PI
PROPOSE TO DO SOME LINE OF
RESEARCH, AND THEN REVIEWER ONE
WHICH IS SUPPOSED TO BE THE MOST
FITTING REVIEWER SAID THAT HAS
BEEN DONE ALREADY, IN REALITY
IT'S NOT, IN OTHER WORDS,
PROGRAM OFFICER AGREES WITH THE
PI. SO IN THAT CASE, I MEAN,
WHAT I NORMALLY DO IS I REACH
OUT TO SRO AND HAVE A
CONVERSATION. AND MY QUESTION
IS SHOULD PI WORK AFTER THIS
CASE? I UNDERSTAND THEY'RE NOT
SUPPOSED TO TALK TO YOU GUYS.
>> I AM GLAD YOU ASKED THAT.
UNFORTUNATELY, NO, WE REALLY TRY
TO SEPARATE AND I THINK THE
SOURCE OF THE CONFUSION MIGHT BE
BECAUSE ICS THAT ALSO DO REVIEW,
YOU KNOW, THE ROLE OF THE SRO
AND THE PO IS DIFFERENT AND SO,
YOU KNOW, AT NCI AND N ISNIB BS
TOO THE SRO IS MORE INVOLVED AT
CSR THE SRO IS NOT INVOLVE IN
THE POST REVIEW DISCUSSIONS.
OUR JOB IS TO MAKE SURE
EVERYTHING IN THE SUMMARY
STATEMENT IS CLEAR ENOUGH SO
THAT, YOU KNOW, WE CAN PREVENT
THIS KIND OF THING. NOW I'M
CERTAINLY WE CAN'T PREVENT THE
PIS FROM BEING DISAPPOINTED,
EVEN UPSET AT THE OUTCOME, YOU
KNOW, THAT'S UNFORTUNATELY THE
GAME. AND, YOU KNOW, WE, YOU
KNOW, NEED TO MAKE SURE TO THAT
THE SUMMARY STATEMENT CONVEYS
WHAT IS THE GENERAL ASSESSMENT
AND SO FOR THE PROGRAM IT IS
IMPORTANT TO KIND OF BE ABLE TO
CONVEY AND TRANSLATE WHAT THE
SUMMARY STATEMENT MEAN TO THE
APPLICANT AND WHAT THEY CAN DO
ABOUT IT. THE ONLY THING THAT
THE SRO COULD BE CONTACTED ABOUT
IS IF THERE'S ANY -- IF THERE'S
ANY ALLEGATION OF BIAS. WHICH
AS I SAID, IF THAT IS
DETERMINED, SO BIAS WOULD NOT
BE, YOU KNOW, THEY DIDN'T LIKE
MY APPLICATION, THEY THOUGHT IT
WASN'T INNOVATIVE ENOUGH. BIAS
WOULD BE, YOU KNOW, I AM GETTING
THE SENSE THAT THERE WAS
SOMETHING AGAINST ME AS AN
INVESTIGATOR. THAT SEEMS TO
HAVE MATRICULATED INTO THIS
APPLICATI
APPLICATION.
>> IF IT'S QUICK YOU CAN ASK.
>> AUDIENCE: YOU MENTIONED IN
THE THREE FACTOR REVIEW APPROACH
THAT THAT THIRD FACTOR ISN'T
SCORED. DID I GET THAT RIGHT?
>> A LITTLE LOUDER.
>> AUDIENCE: YOU MENTIONED THE
THIRD FACTOR IS NOT SCORED? SO
HOW, I DIDN'T QUITE UNDERSTAND
THEN HOW IS IT TAKEN INTO
ACCOUNT? HOW IS IT IMPACTFUL?
>> YEAH, I MEAN, YEAH, SO THE
GOAL BASICALLY IS, YOU KNOW,
THAT FINAL SCORE THE OVERALL
IMPACT SCORE, RIGHT? THE FIRST
TWO FACTORS WILL BE SCORED THE
THIRD FACTOR WILL NOT BE SCORED
SO THAT MEANS THAT YOU MIGHT GET
SOMETHING LIKE, ONE OR TWO AND
OVERALL IMPACT IS FIVE. COMING
FROM THAT LACK OF EXPERTISE OR
LACK OF RESOURCES IN THE THIRD
FACTOR THIS IS A VERY COMMON
QUESTION. NOT ONLY FROM THE
SCIENTIFIC COMMUNITY OR
SOMETHING THAT NIH IS TRYING TO
FIGURE OUT THE BEST WAY TO TRAIN
REVIEWERS ON THAT. SO IT WILL
BE DEPICTED IN THE THIRD FACTOR
IN OTHER WORDS IT WILL SAY
UNACCEPTABLE EXPERTISE OR
RESOURCES. THERE'LL BE A SPACE
FOR THE REVIEWER TO PROVIDE
ADDITIONAL INFORMATION, WHY THEY
FEEL THAT. AND THEN THE OVERALL
IMPACT WILL HAVE TO EXPLAIN WHAT
IT WAS THAT THEY SCORED SO LOW
WE DON'T ANTICIPATE THAT IT WILL
BE A ONE-ON-ONE, AND AN 80 BUT
WE DO WANT TO MAKE SURE THE
REVIEWERS ARE PREPARED TO -- IF
THEY FEEL THE EXPERTISE IS
MISSING AND THE RESEARCH PLAN
STILL NEEDS TO -- WE'RE NOT
GOING BASED ON THE BIO SCHEDULE
BUT HOW WELL THE RESEARCH PLAN
IS OUTLINED. THIS IS ESPECIALLY
IMPORTANT FOR NEW INVESTIGATORS
THEY MIGHT NOT HAVE THAT MY
PUBLICATION TO SPEAK OF BUT THE
RESEARCH PLAN NEEDS TO BE
CLEARLY THOUGHT OUT. ANOTHER
THING THAT'S -- THAT THIS IS
RELEVANT TO IS APPLICATIONS THAT
DON'T -- ARE A PHASE THAT DON'T
REQUIRE PRELIMINARY DATA.
THINGS LIKE THE CATS R 01. NO
PRELIMINARY DATA REQUIRED. SO
THE RESEARCH PLAN REALLY NEEDS
TO BE CLEARLY LAID OUT, CLEARLY
THOUGHT OUT AND WE UNDERSTAND
THAT THERE IS A LIMIT ON SPACE
BUT IT HAS TO BE ABLE TO INSTILL
CONFIDENCE IN THE REVIEWERS THAT
YES, THEY THOUGHT THIS THROUGH
AND THEY KNOW WHAT THEY'RE DOING
AND REGARDLESS OF WHETHER THEY
HAVE BEEN IN THE FIELD FOR 20
YEARS OR 2 YEARS, THEY HAVE
THOUGHT IT OUT ENOUGH TO PROVIDE
FEASIBILITY OR TO EXECUTE
ANOTHER ONE.
>> AUDIENCE: THANK YOU.
>> THANK YOU, DOCTOR COHEN.
>> OKAY.
>> OUR NEXT SPEAKER WILL BE A
PROGRAM MANAGER DISCUSSING THE
WORKSHOP. THANK YOU.
>> GOOD MORNING, EVERYONE, TODAY
I'M GOING TO SHARE A BRIEF
OVERVIEW OF OUR WORKSHOP ON
SYNTHETIC BIOLOGY FOR MOLECULAR
IMAGING IN CANCER WHICH WAS
ORGANIZED BY THE CANCER IMAGING
PROGRAM AT NCI AMEDICAL IMAGING
TECHNOLOGY ARE CENTRAL IN CARE.
IT PLAYS ESSENTIAL ROLES IN
CANCER DETECTION, DIAGNOSIS,
TREATMENT, AND MONITOR. SO
ACCORDINGLY, IMPROVING THE
QUALITY OF THE IMAGING AGENT,
IMAGING METHOD, DIRECTLY
BENEFITTING THE CANCER PATIENT.
SO, SO ONE OF THE CHALLENGE IN
ACHIEVING THE CANCER IMAGING
LIES IN THE DEVELOPMENT OF SUCH
SPECIFIC IMAGING PROBES. THE
IDEAL IMAGING PROBES EVEN IF
THEY HAVE CRUCIAL PROPERTIES AS
LISTED IN THIS PAM ON THE RIGHT
SIDE. IT HAS TO BE SENSITIVE
ENOUGH TO DETECT EARLY LESIONS
OR SMALL TUMORS.
IT HAS TO HAVE THE SPECIFICITIES
TO GIVE ACCURATE DIAGNOSIS. THE
ADDITION TO THAT, THESE
CONTROLLED FUNCTIONALITIES AND
THE LONG-TERM REPORTINGS ARE
CRITICAL PROPERTIES FOR GOOD
IMAGING AGENT THAT'S WHERE YOUR
EXPERTISE IN BIOLOGY COMES IN.
IN SYNTHETIC BIOLOGY, OVER THE
POTENTIAL STATE IS THE DESIGNER
OF IMAGING AGENT TO ADDRESS
THESE CHALLENGES SO LET ME
BRIEFLY SHOW YOU EXAMPLES SHARED
BY THE SPEAKERS IN THIS
WORKSHOP. THE PANEL STUDY DONE
BY THE GROUP FROM THE CALTECH,
FOCUSING ON THE PROCESSING ON
NATURALLY EXISTING PROCESSES.
SO THERE ARE TWO PARTS IN HIS
STUDIES THE TOP ONE FOCUS ON THE
MAGNETIC CRYSTALS WHICH EXIST IN
THE MAGNETIC BACTERIA GUIDE
ALONG THE MAGNETIC FIELD. THE
BOTTOM PANEL IN THE LEFT SIDE IS
THE AIR BUBBLES WHICH EXIST IN
THE AQUATIC BACTERIA. IN
INNOVATIVE ENGINEERING, IN
PROPERTIES SUCH AS GUY DANCE --
GUIDANCE IN THESE PARTICLES.
THIS IS AIR BUBBLES AS THE AGENT
FOR ULTRASOUND IN THESE STUDIES.
THE MIDDLE PANEL IS USING THE
SYNTHETIC RECEPTORS.
SPECIFICALLY USING THE SYNTHETIC
MATCH RECEPTORS I AM SURE YOU
HAVE HEARD THE TALK BY LYNN FROM
UC S KRS
UCSF SO IN THE MIDDLE THERE ARE
TWO STUDIES FROM TWO GROUPS ONE
IS FROM THE GROUP FROM CANADA.
THE SECOND ONE IS FROM THE
WILSON GROUP. THEY UTILIZE
THESE RECEPTORS AND REPLACE THE
EEXTRACELLULAR DOMAIN WITH A
PEPTIDE THAT RECOGNIZE THE
ENERGIES.
THEREFORE YOU HAVE A NOBLE INPUT
IN THE TUMOR SPECIFIC SIGNALS.
THEN REPLACE THE INTRACELLULAR
DOMAIN. THESE ARE FOR
REPORTING. THAT'S -- THEY HAVE
THE WILSON'S STUDY FROM UCSF AND
THE OMI REPORTERS. THEREFORE
THEY CAN CREATE THIS IMAGING
AGENT FOR MRI IMAGING. DESPITE
THESE POTENTIALS THIS FIELD IS
IN AN EARLY STAGE. THIS GAP IS
REALLY THE DRIVING FORCE FOR US
TO ORGANIZE THIS WORKSHOP. THE
GOAL OF THE WORKSHOP IS TO BRING
THE EXPERT LIKE YOU IN SYNTHETIC
BIOLOGY TO WORK WITH THE MEDICAL
IMAGERS TO CREATE A ROBUST,
SENSITIVE AND PRECISION IMAGING
AGENT. SO THIS WILL ULTIMATELY
BENEFIT THE PATIENT OF CANCER SO
THE WORKSHOP WAS ORGANIZED BY
THE CANCER IMAGING PROGRAM IN
COLLABORATION WITH CALTECH AND
THE WORKSHOP WAS MANAGED AND
ASSISTED BY THE VARIOUS FOLKS
FROM NCI AS WELL AS FROM NIBIB.
SO THE MEETING IS VIRTUAL, A TWO
DAY EVENT AND WE RECEIVED
POSITIVE TURNOUTS. WE HAD MORE
THAN 200 PEOPLE ATTEND THIS
WORKSHOP. THEY ARE FOUR
SESSIONS IN THE WORKSHOP OVER
TWO DAYS. SO EACH SESSION --
EACH DAY AS TWO SESSIONS. EACH
SESSION HAS FIVE SPEAKERS SO WE
TOTAL HAVE 20 PRESENTATIONS. WE
HAVE A PANEL DISCUSSION. AT
EACH SESSION. LET ME GIVE YOU
AN OVERVIEW OF THE SCIENTIFIC
SESSIONS. THE FIRST IS ON
APPLICATIONS OF BIOLOGY. IT IS
RARELY SERVED AS PRODUCTION.
THIS SESSION WAS CHAIRED BY JOSH
LEONARD FROM NORTHWESTERN SO HE
STUDIED THE PREDECISION ON
ENGINEERING AND THE INFORMATION
PROCESS.
THEREFORE ANOTHER FROM UCF
DEVELOPED THE -- DEVELOPED A THE
SYNTHETIC RECEPTORS TO IMPROVE
THE SENSITIVITY IN CELLS. THEN
FOLLOWED BY THE HAM MY DIDEPAR
HE'S FROM UNIVERSITY OF PENN.
AND THEN WILSON WONG FROM BOSTON
UNIVERSITY TALKED ABOUT
IMPROVING THE CELLS AS WELL AS
THE CELL AMPLIFIER RNA FOR
VACCINE DEVELOPMENT. AND THE --
THIS SESSION WAS END WITH THE
KEVIN MCHOW -- MCHUGH FROM RICE
UNIVERSITY.
THE SESSION TWO AND THREE AND
FOUR, DIRECTED INTO IMAGING
INNOVATION. AND THUZ WAS
CHAIRED BY MICK HAIL FROM
CALTECH.
AND WAS WORKED WITH IMAGING AND
ULTRASOUND AND THEN FOLLOWED BY
JERSEY TALKED ABOUT THE
NONINVASIVE MANAGING OF BRAIN
ACTIVITIES AND AR NAB FROM UC
SANTA BARBARA TALKED ABOUT THE
ENGINEERING REPORTER GENES FOR
MR IMAGING AND CHRISTOPHER CAVE
A TALK OBJECT SYNTHETIC
ORGANELLE FOR INVIVO IMAGING AND
THIS SESSION ENDED WITH A TALK
FROM NICHOLAS WHO IS FROM THE
NST GROUP FROM STANFORD AND
TALKED ABOUT THE SYNTHETIC GPR.
AND SESSION THREE CONTINUED ON
THE IMAGING FRAME AND THIS WAS
SHARED FROM ONE FROM UKRAINE AND
THIS STUDY GAVE A TALK ON THE
PROTEIN TECH FOR IMAGING THE
IMMUNE CELLS. AND THIS USES
SYNTHETIC ANALYSIS RECEPTORS
INTO REPORTERS. THEN GABE
WORKED WITH EARLY CANCER
DETECTION AND THEN TET SUE HERO
WHAT ARE REE KNOW TO WITH HIS
GROUP AT COLUMBIA, THEY TALK
ABOUT ENGINEERED BACTERIA FOR
DRUG DELIVERY. AND THE SESSION
WAS ENDED WITH TIM TALKING ABOUT
SYNTHETIC BIOLOGY FOR NEXT
GENERATION THERAPEUTICS. THE
LAST SINCE WAS ON CLINICAL NEEDS
AND THIS SESSION WAS CHAIRED BY
ANNA WU AND SHE STUDIED THE
FIRST TALK WITH THE HUMANIZED
ANTIBODIES FOR IMMUNOLOGINOLOGY
INPATIENT CARE. AND THEN WE HAD
DAVID WILSON WHO I MENTIONED HAD
REPORTS FOR CANCER IMAGE AND
THEN VLADIMIR FROM MSK HE TALKED
ABOUT USING THE REPORTER TOOLS
IN THE MODELS AND IN THE PATIENT
CLINICAL TRIALS. OUR FOURTH WAS
LAURA FROM THE UCSF, SHE
SUPPORTED THE CLINICAL TRIALS SO
SHE BASICALLY WAS SOME INSIGHT
HOW TO AUGMENT IMAGING FEATURES
FROM A TUMOR. AND THE FINAL
TALK WAS SUPPORTED BY NCI FROM
THE PINNACLE WORKS GROUP. SO
THEY CREATE AN IMAGING AGENT TO
IMAG
IMAGING LABELS SO THEY ARE
MOVING THIS FROM THE PRECLINICAL
MODELS TOWARD THE CLINICAL
STUDIES. SO WE HAD A LIST OF
SPEAKERS AND VERY EXCITING
RESEARCH. IF YOU WANT TO KNOW
MORE I HAVE A LIST OF LINKS
HERE. THE FIRST LINK WILL TAKE
YOU TO THE MEETING PAGE. YOU
HAVE THE BIO. AND THE NEXT IS
THE WORKSHOP. WITH THAT, I
THANK YOU FOR YOUR ATTENTION.
IF YOU HAVE ANY QUESTIONS.
>> DOES ANYONE HAVE ANY
QUESTIONS? ALL RIGHT. THANK YOU
DOCTOR.
>> THANK YOU.
>> NEXT UP IS DR. FEI WANG.
>> GOOD MORNING I WOULD LIKE TO
THANK THE ORGANIZER FOR INVITING
US. TUBA DO YOU WANT TO JUST
COME UP? YEAH SO TUBA AND I
WILL GIVE YOU A REPORT OF A
WORKSHOP TOOK PLACE LAST YEAR
AND IT WAS ORGANIZED BY NIA AND
NIBIB BY PREVIOUS SUPERVISOR
DR. RON WAS WORKING WITH TUBA
VERY CLOSELY AND MADE THIS
HAPPEN. SO BEFORE WE EVEN GO
INTO THE WORKSHOP, I THOUGHT I
WOULD GIVE YOU A BRIEF
INTRODUCTION OF -- FOR DIVISION
OF AGING BIOLOGY IN THE NATIONAL
INSTITUTES ON AGING. BECAUSE
USUALLY WE ARE THE -- WE ARE NOT
THE NORMAL PLAYER HERE.
I THOUGHT JUST GIVE YOU A LITTLE
BIT OF WHAT WE DO. SO BASICALLY
WE ARE SUPPORTING RESEARCH AND
TRAINING AND TO THE MOLECULAR
LEVEL. ANYTHING BASIC, AGEING
RELATED, DISEASE AND SO ON SO
FORTH. SO WE ARE SORT OF, I
CALL IT THE BASIC EVERYTHING.
OKAY. AND THEN WE HAVE THREE
BRANCHES IN ADDITION. ONE IS
AGING PHYSIOLOGY BRANCH. YOU
SEE MANY PROGRAMS IN HERE. SO
LET'S SEE WHETHER I CAN MAKE
THIS -- YOU SEE ALL THESE
PROGRAMS IN HERE. AND THEN WE
ALSO HAVE CELL BIOLOGY BRANCH.
I LEAD AS A TRANSLATIONAL
RESEARCH BRANCH, I LITERALLY
MANAGE THE SYNTHETIC AGING
BIOLOGY PORTFOLIO AND THE OTHER
RELEVANT ONE YOU MAY WANT TO PAY
ATTENTION IS WE HAVE EMERGENT
TECHNOLOGY PROGRAM SO IN
ADDITION TO DO AGING BASIC
BIOLOGY RESEARCH, WE ALSO
SUPPORT TECHNOLOGY. THERE ARE
MANY ISSUES IN AGING RESEARCH
AND SOME OF THE CHALLENGES COULD
BE MATCHED BY OUR INVESTIGATOR,
WORKING WITH YOU GUYS, WHICH WAS
THE REASON FOR THE WORKSHOP.
>> YEAH SO AS FEI MENTIONED THIS
WORKSHOP GREW OUT AFTER A MUTUAL
INTEREST AND THE APPLICATION OF
BIOLOGY IN HOW WE CAN USE
SYNTHETIC BIOLOGY APPROACHES AND
HOW TO IMPROVE OUR UNDERSTANDING
OF AGING BIOLOGY AND IN TURN
MAYBE TAKE ATE STEP FURTHER IN
USING THESE TOLLS TO IMPACT WHAT
WE LEARNED FROM WHAT WE
UNDERSTAND ABOUT AGING BIOLOGY.
AND TURN THAT INTO A STRATEGIES
TO IMPACT AGING PROCESSES AND
OUTCOMES, AGAIN USING SYNTHETIC
BIOLOGY TOOLS SO THE WORKSHOP
GOAL WAS TO REALLY BRING
TOGETHER THE TWO COMMUNITIES OF
SYNTHETIC BIOLOGY TOOL MAKERS
AND AGING BIOLOGY RESEARCHERS TO
PROMOTE AWARENESS OF SYNTHETIC
BIOLOGY IN THE AGING RESEARCH
FIELD AND ALSO TO FOSTER NEW
COLLABORATIONS AMONG THESE
PARTICIPANTS TO GENERATE
SPECIFIC ACTION PLANS IN TERMS
OF MAYBE JOINT GRANT
APPLICATIONS WE HAD A WONDERFUL
PLANNING TEAM AND PUT TOGETHER
THIS WORKSHOP. TO, AGAIN,
EXPLORE BROADLY IDEAS ABOUT HOW
WE CAN USE SYNTHETIC BIOLOGY TO
TAKE AGING OR SON NECESSARY
SENSE CELLS AND MAYBE TURN BACK
THE CLOCK ON THEM TOWARDS A
NORMAL PHENOTYPE.
AND THE LOGISTICS AND THE FORMAT
OF THIS WORKSHOP BECAUSE OUR
GOALS WERE A LITTLE BIT
DIFFERENT IN TERMS OF, YOU KNOW,
INTRODUCING THESE TWO
COMMUNITIES TO EACH OTHER AND
FOSTERING COLLABORATIONS THIS UZ
WITH UNLIKE A TRADITIONAL NIH
WORKSHOP THAT YOU MAY BE
FAMILIAR WITH WITH FORMAL TALKS.
WE STRUCTURED IT SUCH THAT WE
INVITED FIVE PIS AND FIVE
TRAINEES FROM THEIR LABS FROM
THE AGING RESEARCH FIELD. AND
FROM THE SYNTHETIC RESEARCH
FIELD AND PUT THEM TOGETHER IN A
ROOM AND SO JUST CHAT AWAY
ESSENTIALLY. WE PROVIDED ZOOM
PARTICIPATION FOR OTHERS SO THEY
COULD WATCH THESE DISCUSSIONS
AND THEN PARTICIPATE, ASK
QUESTIONS IN THE CHATBOXES. AND
WE HELD THIS WORKSHOP OVER TWO
DAYS IN 2023 IN SEPTEMBER.
AGAIN, THE EMPHASIS WAS THAT NO
FORMAL SCIENTIFIC TALKS WHILE WE
ASKED THE PARTICIPANTS TO
DISCUSS WAS BROADLY THEIR
EXPERTISE AND THE SCIENTIFIC
QUESTIONS THAT THEY ARE TACKLING
AND WHETHER THERE WERE ANY
INTERSECTIONS WITH THE OTHER
FIELD, RESEARCH FROM THE OTHER
FEEL. SO WE EMPHASIZE MORE
INTERACTIVE DISCUSSION BASED
BREAKOUT SESSIONS AFTER VERY
SHORT INTRODUCTORY TALKS BY EACH
OF THE ATTENDEES AND THE FOCUS
WAS ON, YOU KNOW, WHAT ARE THE
BIGGEST CHALLENGES,
OPPORTUNITIES, OR OUTSTANDING
QUESTIONS IN THE AGING AND
SYNTHETIC BIOLOGY FIELDS
RESPECTIVELY AND WHAT CAN EACH
PERSON OFFER FOR POTENTIAL
COLLABORATIONS TO ADDRESS THESE
QUESTIONS? SO THAT WAS THE
GENERAL GOAL ON THE FORMAT OF
THE WORKSHOP SO THEY ONE, FOR
THAT REASON CONSISTED OF TWO
SETS OF TALKS, VERY SHORT TALKS.
ONE SET WAS FLASH TALKS BY PIS,
ONLY THREE SLIDES, FIVE MINUTES,
THAT'S IT, JUST INTRODUCE WHO
YOU ARE, WHAT YOU WORK ON, WHAT
YOUR EXPERTISE IS AND WHAT
YOU'RE BRINGING TO THE TABLE.
AN ELEVATOR PITCH TO THE OTHERS
IN THE OTHER FIELD AND THEN
FOLLOWED BY LIGHTENING TALKS
AGAIN BY THE TRAINEES TO, JUST,
YOU KNOW, INTRODUCE THEMSELVES
AND, YOU KNOW, TALK ABOUT THEIR
RESEARCH AND EXPERTISE. THEN WE
HAD THREE BREAKOUT SESSIONS AND
STRUCTURED THEM FIRST IN THESE
BREAKOUT SESSIONS WAS WE SORT OF
RANDOMLY PAIRED THESE FOLKS FROM
DIFFERENT FIELDS AND JUST
ENCOURAGED THEM TO DO A MORE
LANDSCAPE ANALYSIS AND BLUE SKY
IDEATION SO WHAT ARE, AGAIN,
SOME OF THESE BIG QUESTIONS?
THAT THEY'RE TRYING TO TACKLE?
AND ASK QUESTIONS LIKE, WOULDN'T
IT BE ARE GREAT IF WE WOULD DO
THIS? WOULDN'T BE IT GREAT IF
WE HAD THIS TOOL TO ANSWER THIS
OUTSTANDING QUESTION IN AGING
BIOLOGY AND THEN VICE VERSA.
WOULDN'T IT BE GREAT IF I TOOK
MY TOOL AS A SYNTHETIC BIOLOGIST
AND APPLY IT IN THIS FIELD OF
AGING BIOLOGY? SO IT'S VERY BIG
PICTURE THINKING. AND THEN WE
DIVIDED THEM UP AGAIN INTO
DIFFERENT BREAKOUT SESSIONS TO,
YOU KNOW, WITH THESE QUESTIONS
IN THEIR MIND, TO TALK ABOUT
POTENTIAL CONNECTIONS AND ANY
MUTUAL INTEREST AND
OPPORTUNITIES THAT MAY BE
OBVIOUS TO THEM AFTER THINKING
ABOUT THESE TYPES OF QUESTIONS.
AND THEN THE THIRD ONE WAS MORE
OF AN OPEN DISCUSSION FORMAT
WHERE, YOU KNOW, THEY EXPANDED
ON THOSE DISCUSSIONS AND
IDENTIFIED SOME, MAYBE, HIGHLY
IMPACTFUL OPPORTUNITIES RELEVANT
OPPORTUNITIES. WE ALSO HAD A
TRAINING SESSION BY TRAINING
OFFICERS FROM NIH AND NIBAB AND
WE WRAPPED UP THAT DAY AND ASKED
EVERYONE TO THINK ABOUT WHAT
THEY DISCUSSED DURING THE DAY
FOR THE NEXT DAY REPORT OUT
SESSION AND THE REPORT OUT
SESSION TO LAY OUT ALL THE
DISCUSSION. THERE WAS A LOT OF
DISCUSSIONS GOING ON AND THE
REPORT OUT FOCUSED ON WHAT THE
NEXT STEPS ARE AND
IDENTIFICATION OF LIKE SOME
SOLID OPPORTUNITIES. SOME
ACTION PLANS. AND WE ALSO -- WE
ALSO DID A PRIORITIZATION OF
THESE IDENTIFIED AREAS. GAP
AREAS AND OPPORTUNITIES WITHIN
THOSE AREAS. SO AGAIN VERY
SPECIFICALLY FOCUSED ON
COLLABORATIONS BETWEEN THE TWO
SCIENTIFIC FIELDS AND THEN WE
WRAPPED IT UP AND IF -- I FORGOT
TO PUT IT IN MY SLIDES BUT IF
ANY OF YOU WANT TO WATCH ANY OF
THE BREAKOUT SESSIONS OR THE
MAIN PLENARY SESSIONS THEY'RE
ALL AVAILABLE ON THE SYNTHETIC
BIOLOGY CONSORTIUM WEBSITE ON
NIBAB AND YOU CAN WATCH THEM AND
THERE'S A WORKSHOP REPORT THAT
IS ON THE WEBSITE YOU CAN READ.
AND THERE WERE GREAT
RECOMMENDATIONS THAT CAME OUT OF
THIS WORKSHOP WHICH FEI WILL NOW
GO OVER.
>> COSO SO T -- SO CLEARLY IT
WAS A VERY SUCCESSFUL WORKSHOP.
AND MANY RECOMMENDATION CAME OUT
OF IT. IN THIS SLIDE I LIST
SOME IN DISCOVERY RESEARCH SOME
THERAPEUTICS, DEVELOPMENT, I
DON'T EXPECT YOU TO READ IT NOW.
AND IF YOU ARE INTERESTED, THERE
IS A WEBSITE ALL YOU NEED TO DO
IS GOOGLE NIBIB WORKSHOP AND
REPORTS, YOU WILL GET THERE. IT
HAS THE EXACT SUMMARIES AND ALSO
SOME DETAILS, RECOMMENDATION.
WHAT CAME OUT REALLY LOUD AND
CLEAR IS -- SOMEHOW THIS IS NOT
WORKING RIGHT. OKAY, SO, SO
BASICALLY YOU GOT TWO SPACE,
RIGHT? YOU HAVE THE BIOLOGY OF
AGING RESEARCH. YOU HAVE THE
SYNTHETIC BIOLOGY INVESTIGATORS.
AND IT IS THE INTERSECTION WE'RE
HOPING THAT YOU GUYS EITHER ARE
THE TWO DEVELOPER OR GOT SOME
IDEAS IN AGING RESEARCH. THAT
WILL HELP US IN THE APPLICATION
AREA. AND I WAS HAVING A
CONVERSATION WITH A TEAM
YESTERDAY ABOUT SIMPLE THINGS
LIKE WE WERE TALKING ABOUT THE
STEM CELL RESEARCH ALL THE TIME,
RIGHT? REGENERATIVE MEDICINE,
HAVE WE THOUGHT ABOUT AGING?
AND WHEN YOU DO IPS CELL YOU
BRING IT BACK TO THE STATE. IN
MY PREVIOUS LIFE I DIDN'T REALLY
CARE ABOUT AGING NOW I'M IN THE
NATURAL INSTITUTE ON AGING, I
THINK ABOUT THESE THINGS. AND
THE AGING POSSESS.
IT'S NOT SIMPLY WE DEAL WITH
ELDERLY. THE PROCESS LEADS TO
AGING. A 50 YEARS OLD IS
DIFFERENT FROM 15 YEARS OLD.
RIGHT? ONE IS RUNNING MARATHON,
ANOTHER ONE HAS ALL THESE KNEE
OSTEOARTHRITIS PROBLEMS SO IN
OTHER WORDS ONE OF THE BIG
CHALLENGE IN OUR FIELD IS WHAT
IS A MARKER FOR AGING? CAN YOU
GUYS BE RELEVANT OF A MARKER FOR
US? JUST SIMPLE THINGS LIKE
THIS I SEE A LOT OF
OPPORTUNITIES FOR US TO WORK
TOGETHER. AND I THINK THE
IMPORTANT THING IS FOR THE TWO
DEVELOPERS ENGAGE WITH THE
INVESTIGATORS WORKING IN THE
AGING BIOLOGY AREA SO YOU CAN
UNDERSTAND EACH OTHER'S
CHALLENGE. OF THE RESULT, YOU
CAN WORK TOGETHER, MAKE THINGS
HAPPEN. SO WITH THAT, I WANT TO
THANK YOU. AND MY CONTACT
INFORMATION TUBA'S CONTACT
INFORMATION IS UP THERE I
WELCOME YOU TO REACH OUT TO US
AND FOR ANY POTENTIAL QUESTIONS
YOU MAY HAVE. THANK YOU.
>> LOOKS LIKE WE HAVE MAYBE ONE
QUESTION MAYBE? ALL RIGHT.
>> AUDIENCE: THANK YOU SO MUCH I
AM SO GLAD I DIDN'T KNOW ABOUT
THIS WORKSHOP UNTIL TODAY. I
ENTER AGING RESEARCH THIS FIELD
THIS YEAR. AFTER APPROACHED BY
THE PLENARY SO I AM GOING TO
TAKE WHATEVER MONEY OR WHATEVER.
ONE THING, THEY ACTUALLY ACCEPT
THE SAID THING THEY NOT THAT
HAPPY WITH THE RESEARCH THE LAST
DECADE OF THE AGING RESEARCH
BECAUSE VERY TRADITIONAL
APPROACH. AND THEN THEY INVITE
ME TO GIVE A TALK IN ONE OF THE
BIGGEST AGING RESEARCH
CONFERENCE IN DENMARK THAT IS
THE MOST BORING CONFERENCE I
EVER ATTENDED. BECAUSE THEY
ONLY TALKING ABOUT VERY
TRADITIONAL APPROACH TO
UNDERSTAND THE AGING. SO THE
QUESTION I HAVE IS, YOU DON'T --
ABOUT THE WORKSHOP LAST YEAR AND
SINCE THAT, DO YOU SEE SOME
CHANGE IN THE PREVIOUS STUDY
SECTION ABOUT AGING RESEARCH?
OR NEW SUBMISSION THAT
INCORPORATE SYNTHETIC BIOLOGY?
>> SO, THE SIMPLE ANSWER IS DO
WE HAVE MORE INVESTIGATOR
WORKING IN THIS SPACE, RIGHT? I
MEAN, WE HAVE OUR ISOS FROM CR
HERE, RIGHT? SO LET ME USE A
DIFFERENT EXAMPLE. YOU KNOW NIH
ALWAYS HAVE THIS COMMON FOUND
ACTIVITY, RIGHT? AND THEN IN MY
PREVIOUS LIFE I ALWAYS TELL
INVESTIGATOR IF YOU ARE THE ONLY
APPLICATION IN THAT 200
APPLICATION STUDIES SECTION DO
YOU THINK YOU WILL HAVE A
REVIEWER THAT APPRECIATES YOUR
WORK?
>> AUDIENCE: I DON'T THINK SO.
THAT'S WHY I HESITATE.
>> IT'S NOT SIMPLY THE STUDY
SECTION. IT IS DO WE HAVE A
COMMUNITY, RIGHT? SO IF WE HAVE
A COMMUNITY THEN THE REVIEWERS
WILL BE MORE. YOU WOULDN'T
INVITE A SPECIFIC REVIEWER WHEN
YOU HAVE ONE APPLICATION IN YOUR
STUDY SECTION YOU ONLY INVITE 25
REVIEWERS. IT'S AS SIMPLE AS
THAT SO THAT'S WHY I AM HERE TO
TELL YOU GUYS, NOT ONLY NIBIB IS
INTERESTED. NOT ONLY CI. AGING
IS ALSO INTERESTED.
>> AUDIENCE: OKAY, I AM HAPPY TO
CREATE A COMMUNITY WITH SOME
YOUNG PEOPLE WITH YOU. THANK
YOU.
>> ANY OTHER QUESTIONS? GREAT.
THANK YOU, BOTH.
>> THANK YOU.
>> I WILL STAY ON FOR MY
PRESENTATION.
>> NEXT IS TALKING ABOUT AN
EXCITING NEW MECHANISM THAT SHE
DEVELOPED.
>> OKAY, SO THIS ONE IS A NEW
PROGRAM THAT WE LAUNCHED AT
NIBIB IN COLLABORATION WITH THE
NSF AND IT'S CALLED BIOMEDICAL
RESEARCH INITIATIVE FOR NEXT
GENERATION BIOTECHNOLOGIES. SIN
BIO CONTROL EDITION. THIS IS A
SOLICITATION THAT HIT THE
STREETS SOMETIMES IN SEPTEMBER.
AND THE DEADLINE IS DECEMBER
4TH. YOU HAVE ABOUT TWO WEEKS.
IF YOU ARE RUSHING BUT HOPEFULLY
YOU'VE HEARD ABOUT IT A WHILE
AGO BECAUSE WE SENT OUT A LOT OF
E-MAILS AND PUT IT ON OUR
WEBSITE. SO WE DID A LOT OF
RESEARCH TO THE SYNTHETIC
BIOLOGY COMMUNITY AND I WANT TO
USE THIS OPPORTUNITY TO GO OVER
WHAT THE PROGRAM'S ABOUT AND THE
GOALS OF IT. AND AGAIN, I DON'T
EXPECT ANYONE TO PUT TOGETHER A
BRAND NEW APPLICATION BY
DECEMBER 4TH BUT YOU CAN BE
AWARE OF THE APPROACH WE TOOK IN
THIS NEW TYPE OF COLLABORATION
WITH THE NSF. IF YOU WOULD LIKE
TO READ ABOUT THIS, THIS IS THE
WEBSITE HERE AND THERE IS ALSO A
WEBINAR WE HELD FOR POTENTIAL
APPLICANTS THAT GO OVER THE
SOLICITATION AND THE
REQUIREMENTS THAT YOU COULD ALSO
WATCH. NOW, BRING SIN BIO WE
DEVELOPED THIS PROGRAM AS A
COLLABORATION TOOL BETWEEN TWO
AGENCIES THAT ARE INTERESTED IN
FUNDING SYNTHETIC BIOLOGY
RESEARCH.
OR INTERESTED IN COLLABORATING
IN GENERAL. SO WE HAVE HAD
LONG-STANDING COLLABORATIONS
WITH THE NDF AND OTHER PROGRAMS
BUT AS WE ALL KNOW RESEARCH IS A
SPECTRUM AND INTERESTS FALL AT
THE DIFFERENT ENDS OF THE
SPECTRUM AND FOR OUR PURPOSES
WITHIN THIS COLLABORATIVE SPACE
NSF FALLS ON THE MORE
FOUNDATIONAL ASPECT OF QUESTIONS
ASKED WHEREAS NIH IS INTERESTED
IN MORE BIOMEDICAL AND HEALTH
RELEVANT RESEARCH SO WE SORT OF
FALL ON THE OPPOSITE ENDS OF THE
SPECTRUM. AND BECAUSE OF THAT,
THE NATURE OF THE EXISTING
COLLABORATIONS WITH THE NSF HAS
MOSTLY FALLEN IN A SPACE THAT IS
IN BETWEEN WHERE, FOR EXAMPLE,
AN APPLICATION OR A RESEARCH
PROJECT COULD EITHER GO TO THE
NSF OR NIH IN GENERAL. SO WHAT
WE WANTED TO DO WAS TO REALLY
CAPTURE MORE OF THE DISCOVERIES
THAT HAS COME OUT OF
FOUNDATIONAL, MORE FOUNDATIONAL
RESEARCH, SO TOWARDS THE LEFT
END OF THE SPECTRUM, LET ME SEE
IF I CAN GET A LASER POINTER WE
FELT THE KNOWLEDGE AND THE
INNOVATION AND DISCOVERIES THAT
COME OUT OF FROM THE NSF SPACE
TOWARDS A MORE FOUNDATIONAL
RESEARCH AREAS, SO THE STATE
SILOED AND DID NOT MAKE THEIR
WAY INTO THE NIH DOMAIN BECAUSE
OF THE HIGH ACTIVATION THRESHOLD
OF PUSHING THESE DISCOVERIES
INTO THE NIH DOMAIN APPLICATION
INTO THE HUMAN RELEVANCE AREAS.
SO WHO WE WANTED TO DO WAS TO
REALLY CAPTURE THE KNOWLEDGE
THAT COMES OUT OF NSF AND PUT IN
INTENTIONAL DIRECTIONALITY OF
TAKING THIS KNOWLEDGE AND
TURNING INTO BIOMEDICALLY
RELEVANT RESEARCH PROJECTS AT
THE NIH SO OUR GOAL WAS TO,
AGAIN, BRIDGE MORE OF THE
FOUNDATIONAL RESEARCH
DISCOVERIES AND THEIR
APPLICATIONS IN THE BIOMEDICAL
SPACE BY PUTTING IN THIS ARROW
HERE. SO WE THOUGHT LONG AND
HARD ABOUT IT. AND HAD TO JUMP
THROUGH A LOT OF BUREAUCRATIC
HOOPS AND LOOPS BUT WE MADE IT
HAPPEN IN A UNIQUE WAY. AND
WHAT WE DECIDED TO DO WAS AGAIN,
TAKE A RESEARCH PROJECT BUT
SPLIT IT INTO TWO PHASES. SUCH
THAT THERE WOULD BE AN ACTUAL
CONNECTION BETWEEN THE TWO
PHASES. THAT PUTS IN THAT, YOU
KNOW, DIRECTIONALITY OF THIS
ARROW. SO WE CALL IT A BIPHASIC
APPROACH BECAUSE THERE ARE TWO
PHASE TO THE RESEARCH PROJECT.
AND THE RESEARCH IS A SINGLE
APPLICATION.
A SINGLE PROPOSAL. WITH AN
INTEGRATED PROJECT THAT ALLOWS
THE RAPID AND SEAMLESS
TRANSITION OF FUNDAMENTAL
DISCOVERIES. WITHIN THE NSF
DOMAIN. WE CALL THIS PHASE ONE.
AND SHEPHERD THEM THROUGH TO
BIOMEDICALLY RELEVANT
TECHNOLOGIES THAT ARE WITHIN NIH
MISSION. IN PHASE TWO. SO WE
INTENTIONALLY LINKED THE TWO
PHASES SUCH THAT WHATEVER COMES
OUT OF PHASE ONE WOULD NATURALLY
NOW INTO PHASE TWO NOW THE
ADVANTAGES OF THE BIPHASIC
CONCEPT IS NOT ONLY IS THIS A
UNIQUE FUNDING TOOL FOR
INTERAGENCY COLLABORATION AGAIN
TAKING NSF DISCOVERIES THAT MAY
MAKE THEMSELVES SILOED AND NOT
MAKE THEIR WAY INTO NSF OR
DISCOVERIES. AND I THINK OF
COMPUTER SCIENCE, BUT TAKE THOSE
AND TURN THEM INTO HUMAN HEALTH.
AND THERE IS ALSO AN INTENTIONAL
PUSHING AND PULLING OF THESE
FUNDAMENTAL DISCOVERIES, AGAIN,
THE ARROW THAT I DISCUSSED
EARLIER. WHERE NSF
INTENTIONALLY PUSHES DISCOVERIES
OUT OF PHASE ONE. AND WE PULL
IT INTO PHASE TWO. AT THE NIH
SO THEY AGAIN BRING IN THAT
DIRECTIONALITY SO THIS PROVIDES
A RAPID PATHWAY FOR CONTINUED
ACTIVITIES AT THE NIH WITHOUT A
BREAK IN FUNDING IN PHASE ONE
BECAUSE OTHERWISE, PEOPLE WOULD
DO THEIR RESEARCH AT NSF AND
MAYBE NOT BOTHER TAKING A STEP
FURTHER IN APPLYING FOR AN NIH
GRANT TO TURN IT INTO
DISCOVERIES RELEVANT TO OUR
MISSION SO WE WANTED TO SORT OF
DECREASE THAT ACTIVATION ENERGY
AND SORT OF PROVIDE THIS
PATHWAY, RAPID PATHWAY FOR
CONTINUED ACTIVITIES AND ALSO
WHAT THIS BRING TO THE TABLE IS
THAT PHASE ONE IS AN INDEPENDENT
NSF AWARD. SO WE ROLLED TWO
AWARDS INTO ONE. IT'S LIKE BUY
ONE GET ONE FREE ALTHOUGH PHASE
TWO IS NOT GUARANTEED THIS
PROVIDES THE P SISHGS THEY GET
TWO INDEPEN -- AWARDS AS WELL.
WE SEE IT AS A WIN-WIN AGAIN WE
STRUCTURED THIS PROGRAM IN TWO
PHASES. AND PHASE ONE SHOULD
FIT INTO THE NSF AND INTERESTS.
AND PHASE TWO SHOULD FIT INTO
NIBIB MISSION AND INTERESTS SO
PHASE ONE IS MOSTLY PROOF OF
PRINCIPLE, FOUNDATIONAL, SIN
THREAT -- SYNTHETIC.
AND THEN, PHASE TWO, WOULD
EXPAND ON THIS KNOWLEDGE
GENERATED DURING PHASE ONE.
TOWARDS EXPANDED BIOMEDICAL
TECHNOLOGY DEVELOPMENT WHICH IS
SUPPORTED BY NIBIB. BUT THESE
TWO PHASES CANNOT BE
INDEPENDENT. THEY'RE A NATURAL
CONTINUATION OF EACH OTHER SO TO
DO THAT YOU NEED TO
INTENTIONALLY LINK THEM
SCIENTIFICALLY AND YOU DO THAT
BY MILESTONES. THESE ARE
QUANTITATIVE BENCHMARKS FOR
JUSTIFYING CONTINUATION INTO
PHASE TWO. OF PHASE ONE
RESEARCH SO PHASE ONE AT THE END
OF PHASE ONE, WE INCLUDED A
REQUIREMENT FOR MILESTONES SUCH
THAT THE PI WOULD KNOW THAT THEY
HAVE SUCCEEDED. THEY HAD THEIR
BENCHMARKS AT THE BEGINNING SO
THIS IS INCLUDED IN THE
APPLICATION PACKAGE. THEY KNOW
WHAT SUCCESS LOOKS LIKE. AT THE
END OF PHASE ONE AND THEN IF
THEY ACHIEVE THEIR MILESTONES
THEY HAVE THE RIGHT TO CONTINUE
INTO PHASE TWO. SO IF THEY
HAVE, IF THINGS DIDN'T WORK OUT.
IF THEY DIDN'T REACH THEIR
MILESTONES IT'S AN INDICATION
THAT MAYBE IT'S TIME TO PULL THE
PLUG ON THE PROJECT. AND WE DO
NOT SUPPORT CLINICAL TRIALS FOR
THIS VERSION OF THE BRING SIN
BIO PROGRAM.
SO, AGAIN, JUST TO GIVE YOU THE
OVERVIEW, THE PHASE -- WHAT'S
UNIQUE ABOUT THE PROGRAM IS NOT
ONLY THE PHASE ONE AND THE PHASE
TWO AND THE SEPARATION OF
ACTIVITIES BUT ALSO THE
INCLUSION OF MILESTONES AS A
BRIDGE AND A GO-NO-GO
TRANSITION. GO-NO-GO DECISION
POINT FOR TRANSITIONING OF THESE
PHASE ONE ACTIVITIES INTO PHASE
TWO. THERE THESE TO BE A GOOD
JUSTIFICATION FOR CONTINUED
FUNDING FOR THE PROJECT. SO THE
GO-NO-GO DECISION IS BASED ON
SUCCESSFUL COMPLETION OF PHASE
ONE MILESTONES AND THIS WILL BE
ADMINISTRATIVELY EVALUATED BY
NIBIB TO DETERMINE ELIGIBILITY
AND THE TRANSITION TO PHASE TWO
IS NEITHER AUTOMATIC OR
GUARANTEED. YOU HAVE TO SHOW US
THAT YOU HAVE BEEN SUCCESSFUL
AND WE'RE STILL INTERESTED IN
THE PROJECT AS THE TIME OF
TRANSITION. JUST TO GIVE YOU AN
IDEA OF AWARD SIZE AND
TRANSITION. SO TO BRING AN
UMBRELLA FOR COLLABORATION IS A
BIG UMBRELLA. THE BRING SIMPLE
BIO WAS A TEST CASE FOR TRYING
THIS COLLABORATION.
SO WE WANTED A PILOT'S CASE
ESSENTIALLY. SO IT'S THE -- THE
AWARD AMOUNTS ARE NOT VERY BIG
BUT IT'S FOR TWO YEARS:
AND EACH AGENCY. AND NSF
PROVIDES AN ESTIMATED OF, YOU
KNOW, 300,000 DOLLARS TOTAL
COSTS OVER TWO YEARS. AND
ESTIMATES TO MAKE 6-8 AWARDS.
THE DEADLINE IS NOT, YOU KNOW,
PAST YET SO WE'RE STILL, WE
DON'T KNOW HOW MANY -- WE WILL
RECEIVE BUT WE PLAN TO MAKE SIX
TO EIGHT AWARDS AT THE NSF AND
THEN NIH WILL PROVIDE SOMETHING
ALONG THE LINES OF AN OUGHT 21.
SO A TWO YEAR PROJECT, 275,000
DOLLARS COST IN TWO YEARS. AND
NOT EVERYBODY WILL TRANSITION.
SO THERE NEEDS TO BE A GOOD
JUSTIFICATION FOR HITTING THE
MILESTONES AND OTHER CRITERIA.
SO WHAT'S DIFFERENT THEN --
DIFFERENT IN THIS PROGRAM THAN
OTHERS IS THE APPLICATIONS NEED
TO INCLUDE SEPARATE, YOU KNOW,
RESEARCH PLANS FOR PHASE ONE AND
PHASE TWO. AND FOR SUBJECT
BUDGETS FOR EACH PHASE ONE AND
PHASE TWO. THERE'S SOME
BUREAUCRACY THERE. THAT WE HAVE
TO FIGURE OUT AND TO REITERATE
NOT ALL AWARDS WILL TRANSITION.
NOW, HOW ARE THESE PROPOSALS
REVIEWED AND FUNDED? AGAIN
BECAUSE THIS IS A TRUE
COLLABORATION BETWEEN THE TWO
AGENCIES WE DECIDED THAT THE
APPLICATIONS WILL GO TO NSF
BECAUSE WILL IMPLEMENT PHASE ONE
AND THAT WILL BE AN NSF PROJECT
ESSENTIALLY AND SO THE
APPLICATION CONTAINS BOTH NSF
AND NIH PORTIONS OF THE RESEARCH
BUT GOES TO NSF FOR REVIEW. THE
REVIEW IN -- THE REVIEW PANEL
INCLUDES REVIEWERS IDENTIFIED BY
THE NSF AND ALSO AN NIH REVIEW
OFFICER WITH OTHER
REPRESENTATIVES SUCH AS ME AND
PROGRAM STAFF AS OBSERVERS AND
AFTER THE REVIEW FUNDING
DECISION ARE MADE JOINT BY BY
THE PROGRAM STAFF BECAUSE AGAIN,
WE BOTH NEED TO FEEL COMFORTABLE
THAT PHASE ONES FITS WHAT THEY
ARE LOOKING FOR AND THERE'S A
NATURAL CONTINUATION OF EACH
OTHER. AND NSF WANTS PHASE ONE
AND TWO YEARS LATER NIH FUNDS
PHASE TWO. AGAIN, AFTER THE
ADMINISTRATIVE REVIEW OF THE
TRANSITION CHECKPOINT. TO
ENSURE THE SUCCESS OF THIS
CONCEPT, IT'S BRAND NEW, WE PUT
IN TWO CHECKPOINTS IN THERE IN
TERMS OF PROGRAMMATIC OVERSIGHT
AND THE FIRST IS THE
QUANTITATIVE MILESTONE SO IT'S
UP TO THE PI TO COME UP WITH
WHAT SUCCESS LOOKS LIKE AT THE
END OF PHASE ONE BUT WE CAN LOOK
AT THESE BENCHMARKS AND
NEGOTIATE WITH THE PI BEFORE WE
MAKE AN AWARD THAT, YOU KNOW,
YOUR SUCCESS BENCHMARKS ARE A
LITTLE VAGUE, LET'S NEGOTIATE
THEM TO MAKE IT A LITTLE MORE
CONCRETE, FOR EXAMPLE. AND SO
THE INCLUSION OF THOSE
MILESTONES, HOLDING THEM UP TO A
CERTAIN STANDARD OF SUCCESS IS
MEANT TO ENSURE SUCCESS OF THE
PROJECT. THE SECOND ONE IS THE
ADMINISTRATIVE MIDPOINT
PROGRAMMATIC REVIEW. AGAIN,
THERE ARE THREE CRITERIA FOR
JUSTIFYING TRANSITIONING A
PROJECT INTO PHASE TWO AND ITS
SUCCESSFUL COMPLETION OF
MILESTONES AND THAT'S NOT BY
ITSELF SUFFICIENT. THE SECOND
CRITERIA IS NIBIB PROGRAM
PRIORITIES IF YOU SUBMIT THE
APPLICATION DECEMBER 4TH IT'LL
BE TWO YEARS. WE DON'T KNOW
WHAT OUR PRIORITIES WILL BE AT
THAT POINT IN TIME SO WE RESERVE
THE RIGHT TO SAY THIS IS NO
LONGER AN INTEREST OF OURS OR WE
DON'T HAVE THE FUNDS FOR IT. SO
THESE CRITERIA NEED TO BE MET
AND THE TRANSITION IS NEITHER
AUTOMATIC OR GUARANTEED BUT
ANYONE WHO IS IN PHASE ONE CAN
SUBMIT A PACKAGE TO CONTINUE
INTO PHASE TWO BUT WE WILL
REVIEW THAT THERE WILL NOT BE
ANY SCIENTIFIC PEER REVIEW.
ASSOCIATED WITH IT. NOW, THE
AREAS OF INTEREST WE IDENTIFIED
FOR THE PURPOSES OF THIS
PARTICULAR PILOT SOLICITATION IS
THE USE OF BIOLOGICAL CONTROL
THEORY AND THE DESIGN AND
CHARACTERIZATION OF EITHER NEW
SIN BIO TOOLS AND PARTS AND
THEIR -- OR THEIR, DOWNSTREAM
APPLICATION TO TECHNOLOGY
DEVELOPMENT IN THE BIO MEDICAL
FIELD THIS IS, IT'S -- IT'S NOT
ONLY LIMITED TO THESE AREAS
OUTLINED HERE BUT THE IDEA IS
THERE SHOULD BE INCLUSION OF
SOME ASPECT OF CONTROL THEORY
INTO THESE PROJECTS. AND IT
COULD INCLUDE GENE CIRCUIT
DESIGNS FOR ENHANCING
RELIABILITY, PREDICTABILITY OF
CURRENT GENE CIRCUIT DESIGNS OR
NEW STRATEGIES. FOR
INCORPORATING NOVEL FEEDBACK
STRATEGIES AND WHATNOT. THESE
ARE INCLUSIVE BUT NOT LIMITED TO
THESE BULLET POINTS. NOW FOR
THE TIMELINE, AGAIN, THE
SOLICITATION WAS ISSUED SOMETIME
IN SEPTEMBER OR END OF AUGUST
AND THE PROPOSALS ARE DUE IN A
COUPLE OF WEEKS THE REVIEW WILL
TAKE PLACE IN FEBRUARY/MARCH AND
THE FIRST AWARDS WILL BE MADE IN
APRIL/MAY OF NEXT YEAR AND THEN
THE TRANSITION REVIEW WILL BE
ROUGHLY 21 MONTHS AFTER THESE
AWARDS ARE MADE AND THEN AT THE
24 MONTH MARK, THOSE WHO ARE
GRANTED PERMISSION TO EXTEND
INTO PHASE TWO WILL BE AWARDED.
AND THAT CORRESPONDS TO AGAIN,
APRIL/MAY 2027. AND THESE ARE
MY WONDERFUL COLLEAGUES AT THE
NSF WHO WORKED WITH ME IN
LAUNCHING THIS PROGRAM SO IF YOU
HAVE ANY QUESTIONS ABOUT THE
PROGRAM OR WHAT MIGHT BE A GOOD
FIT FOR NSF OR NIH FEEL FREE TO
REACH OUT TO US AND I AM HAPPY
TO TAKE ANY QUESTIONS.
>> GIVEN FIRST DEADLINE IS
COMING UP QUITE SOON WHAT DO YOU
THINK IS IF THE LIKELIHOOD THAT
THIS PROGRAM WILL BE RENUED A
FEW YEARS FROM NOW?
>> WE TO NOT KNOW. WE DON'T
KNOW. WE GOT GREAT FEEDBACK
FROM THE COMMUNITY.
AS TO, YOU KNOW SH,KNOW, EXCITI
THOUGHT THE PROGRAM WAS. FOR
NOW IT'S A PILOT PROGRAM. WE'RE
TESTING IT OUT AND THE UMBRELLA
IS THERE SO WE CAN USE THIS FOR
FUTURE COLLABORATIONS BUT WE
DON'T KNOW.
>> AUDIENCE: THIS IS A REALLY
CLEVER CONCEPT. I LOVE IT. I
ASSUME THERE'S NO OPPORTUNITY
FOR A NO COST EXTENSION IN THAT
PERIOD. YOU NEED TO BE READY IN
TWO YEARS TO TRANSITION ON.
>> THIS CAME UP AND MAYBE IS THE
ANSWER. IT DEPENDS BECAUSE EACH
AGENCY HAS THEIR OWN POLICIES
AND PROCEDURES IN PLACE. I
ACTUALLY CANNOT SPEAK FOR THE
NSF BUT I KNOW THIS QUESTION
CAME UP AND WE WILL EVALUATE IT
ON A CASE-BY-CASE BASIS. SO WE
DIDN'T RULE IT OUT BUT WE HOPE
THAT THINGS WILL BE
TRANSITIONING SMOOTHLY.
>> ANY OTHER QUESTIONS? ALL
RIGHT. THANK YOU.
>> THANK YOU.
>> NEXT UP JER MONTH CHEN IS
GOING TO BE TALKING ABOUT THE
SUMMARY OF THE BIOLOGY WORKSHOP.
>> THANKS NICOLE. ON BEHALF OF
THE HEART AND LUNG SYNTHETIC
BIOLOGY WORKING GROUP I'M GOING
TO PRESENT A SHORT SUMMARY OF
THEIR TWO DAY ONLINE WORKSHOP.
SO JUST LIKE YOU HEARD FROM
AGING, JUST LIKE YOU HEARD FROM
CANCER, HEART AND LUNG ALSO
WANTS TO FUND IN THE SYNTHETIC
BIOLOGY WORKSHOP SO, AGAIN, IT
WAS A TWO DAY WORKSHOP THE
CO-CHAIRS WERE KATIE. AND I'M
SURE YOU'RE FAMILIAR WITH THEIR
WORK IN THE SYNTHETIC BIOLOGY
FIELD SO THE MAIN GOAL HERE WAS
TO IDENTIFY AND TEAM DEVELOPERS
AND USERS IN ORDER TO HELP
HEART, LUNG, BLOOD AND SLEEP.
LOOK AT THEIR DISEASE RESEARCH.
SO, AGAIN, IT WAS A TWO DAY
ONLINE MEETING. AND THEIR GOAL
IS TO ESTABLISH A WORKSPACE IN
THIS CASE, YOU CAN SEE THE
PICTURE. IT'S A SANDBOX WITHIN
HEART, LUNG, BLOOD INSTITUTE
WHERE THE TECHNOLOGY
DEVELOPMENT, FOR SYNTHETIC
BIOLOGY HAS A HOME. SO THEIR
GOALS HERE, VERY SIMILAR TO SOME
OF THE OTHER GOALS THAT THE
OTHER INSTITUTES LIKE THE NIBIB
AND AGING GOALS WERE TO FORM
TEAMS TO PREPARE APPLICATIONS TO
SUBMIT TO HEART, LUNG AND BLOOD.
AND WHAT THEY'RE IN THE PROCESS
OF DOING IS CREATING A
PUBLICATION FOR RELEASE AND THAT
WILL BE POSTED ON BOTH THE
HEART, LUNG AND BLOOD WEBSITE
ALONG WITH THE NIH SIN BIO
WEBSITE. SO THESE WERE THE
GUIDING THOUGHTS OF THE
WORKSHOP, KIND OF UNDERSTANDING
THE LANDSCAPE OF WHAT HEART,
LUNG, BLOOD SLEEP WANTED TO DO.
AND THE FLASHLIGHT IS SYNTHETIC
BIOLOGY KIND OF GOING OVER,
TRYING TO FIT WHERE SYNTHETIC
BIOLOGY CAN FIT ANY OF THOSE
CATEGORIES. HOW CAN -- HOW CAN
THIS -- HOW CAN THEY ADD THIS TO
TRAINEES THINKING? HOW CAN THEY
DEVELOP THE NEXT GENERATION OF
THERAPIES AND DIAGNOSTICS? AND,
AGAIN, HOW CAN SYNTHETIC BIOLOGY
AT HEART, LUNG AND BLOOD ENABLE
THE GOAL THEY WANTED TO CREATE
WHICH IS COLLABORATIONS GOING
FORWARD? SO THESE WERE THE
TAKEAWAYS FROM THE MEETINGS.
AGAIN, THE VIDEOS WERE RECORDED
AND AT SOME TIME THEY'LL BE
POSTED TO THEIR WEBSITES: AGAIN,
MODEL DEVELOPMENT AND AGING
EVENTS WITH DISCREET TIMING AND
SPATIAL DATA.
ACCESSIBLE TISSUES FOR STUDYING
DEVELOPMENT. FIBROSIS
MECHANISMS WITH HEART FAILURE
AND PULMONARY FIBROSIS AND
CARDIOTOXICITY YOU CAN SEE THESE
ARE HEART, LUNG, BLOOD, SLEEP
CATEGORIES AND WITH THAT, LIKE I
SAID, THE VIDEOS WILL BE POSTED
ON THE HEART, LUNG AND BLOOD
WEBSITES ALONG WITH THEIR
PUBLISHED REPORT AND THAT WILL
BE ALSO LINKED ON THE NIH
CONSORTIUM WEBSITE. SO IF YOU
HAVE ANY QUESTIONS, I'M NOT SURE
I CAN ANSWER THEM BUT WE CAN --
WE'LL JUST WAIT FOR THE
PUBLICATION TO BE FINAL IDEAS
AND POSTED TO THEIR WEBSITE.
OKAY. THANK YOU VERY MUCH.
>> AND OUR NEXT SPEAKER IS
DR. CONNIE SOME HERS AND HAS AN
UPCOMING WORKSHOP IN VIVO
ENGINEERING.
>> THANK YOU FOR STICKING AROUND
FOR THE LAST WORKSHOP TALK I'M
GOING TO BE TALKING ABOUT A
WORKSHOP CALLED INVIVO
ENGINEERING. AND IT'LL BE HELD
IN JANUARY 28TH AND 29TH AND BE
A VIRTUAL WORKSHOP AND I AM
PRESENTING ON BEHALF OF THE
PLANNING COMMITTEE LISTED HERE
SO JUST A BIT OF BACKGROUND, AS
YOU ALL KNOW, THERE ARE THE
HISTORIC PILLARS SUCH AS
CHEMOTHERAPY, MORE RECENTLY
IMMUNOTHERAPY HAS COME ON THE
SCENE AND THAT'S BASICALLY MEANS
TARGETING THE IMMUNE SYSTEM TO
KILL THE CANCER RATHER THAN
TARGETING THE TUMOR CELLS
THEMSELVES. AND THERE ARE THESE
DIFFERENT KINDS OF
IMMUNOTHERAPIES LISTED HERE.
THE MOST NOTABLE ONES RECENTLY
HAVE BEEN IMMUNE CHECKPOINT
BLOCKADES LIKE ANTIPD ONE AND
ANTICT LSHG 4 FOR TREATING
CANCERS.
AND ADOPTIVE CELL THERAPIES AND
THE MOST ADVANCED ARE CAR-T CELL
THERAPIES SO THAT IS WHAT I WILL
CONCENTRATE ON TODAY BUT THERE
ARE OTHER ADOPTIVE CELL
THERAPIES LIKE MACROPHAGES AND
DEN DRDRITIC CELLS, ET CETERA. D
THESE THERAPIES HAVE BEEN USED
INITIALLY TO TREAT HAEMATOLOGIC
MALIGNANCIES. THEY ARE SINCE
FDA APPROVED AND FOR SOLID
THERAPIES THERE'S ONE ADOPTIVE
CELL THERAPY APPROVED WHICH IS
TUMOR INFILTRATED FOR MELANOMA.
SO A LITTLE BIT MORE ABOUT CAR-T
CELL THERAPY SO WE'RE ALL ON THE
SAME PAGE WHAT HAPPENS IS, THAT
BLOOD IS REMOVED FROM THE
PATIENT. AND THEN T-CELLS ARE
PURIFIED FROM THE BLOOD. AND
THEN THE T-CELLS ARE ENGINEERED.
SO USUALLY USING A VIRUS, A
CHIMERIC ANTIGEN RECEPTOR IS
INSERTED INTO THE T CELLS AND
THEN IT'S EXPRESSED ON THE YOU
ARE -- SURFACE AND THEN GOES
BACK INTO THE PATIENT AND THEY
GET A LIMB FOE DEPLETING OR
PRECONDITIONING USUALLY
CHEMOTHERAPY TO ALLOW SPACE FOR
THE CAR-T CELLS TO COME AND AND
START TO EXPAND AND THEN THE
CHIMERIC ANTIGEN RECEPTOR HONES
TO THE CANCER CELLS AND IS
CAPABLE OF KILLING THE CANCER
CELLS SO THAT'S KIND OF HOW IT
WORKS. AND IT WORKS WELL AND
IT'S PRETTY LABORIOUS. THERE'S
THE EX VIVO MANIPULATION OF
CELLS SO THAT'S THE GENETIC
ENGINEERING OF THE CELLS. IT
REQUIRES HIGHLY SKILLED
PERSONNEL. IT REQUIRES GMP
MANUFACTURING AND PRODUCTION.
AND I ALSO MENTIONED THE LIMB
FOE DEPLETION THAT THE PATIENTS
HAVE TO DO.
AND SO THIS REQUIRES SPECIALIZED
FACILITIES, SPECIALIZED
PERSONNEL. IT'S RELATIVELY
TIME-CONSUMING. SO BETWEEN THE
TIME THAT THE BLOOD IS COLLECTED
FROM THE PATIENTS TO THE TIME
THAT IT'S ADMINISTERED BACK, CAN
BE A FEW WEEKS AND IF THE
PATIENTS ARE VERY SICK TO START
WITH, WHICH, YOU KNOW, WHEN
YOU'RE BEGINNING A NEW THERAPY,
YOU'RE GOING TO GET THE PATIENTS
WHO HAVE FAILED OTHER THERAPIES
AND ARE VERY SICK. YOU KNOW,
THAT CAN BE A PROBLEM THAT
THEY'RE TOO SICK BY THE TIME TO
GET THE THERAPY. OR EVEN THAT
THEY HAVE DIED. AND THE COST IS
ABOUT 500,000 DOLLARS PER SHOT
SO IT'S VERY EXPENSIVE. NOT
EVERYONE CAN AFFORD THAT. SO
THAT MAKES IT, BOTH THE
SPECIALIZED PROCESSING AND THE
COST MAKE IT LESS ACCESSIBLE TO
BROAD PATIENT POPULATIONS.
THERE'S A COMPLEX REGULATORY
PROCESS BECAUSE IT'S A LIVING
CELL PRODUCT NOT A DRUG WHERE
YOU CAN JUST TAKE A PILL. THERE
ARE STILL SOME CHALLENGES WITH
EFFICACY IN TERMS OF PERSISTENCE
OF THE CAR-T-CELLS AND THERE ARE
SAFETY CONCERNS BOTH RELATED TO
PUTTING IN ALL THOSE CELLS THAT
BECOME ACTIVATED AND ALSO
CONCERNS FROM THE LIMB FOE
DEPLETION PROCESS.
WHICH RENDERS THE PATIENTS
SUSCEPTIBLE TO INSPECTION BOTH
WHEN THEY'RE IN THE HOSPITAL AND
EVEN, YOU KNOW, AFTERWARDS WHILE
THEY'RE RECOVERING. SO, THIS --
IN VIVO ENGINEERING IDEA IS TO
CUT OUT SOME OF THE THOSE MORE
PROBLEMATIC PIECES OF THE
ADOPTIVE CELL THERAPIES. SO
WITH IN VIVO ENGINEERING, YOU
REPROGRAM THE IMMUNE CELLS
INSIDE OF THE BODY RATHER THAN
TAKING THE CELLS OUT.
REPROGRAMMING THEM, AND PUTTING
THEM BACK IN AND I WILL GET INTO
HOW THAT'S DONE BUT BASICALLY
THERE'S NO LEUKOPHORESIS
REQUIRED. NO LIMB FOE DEPLETION
FOR THE PATIENTS THERE'S NO EX
VIVO MANIPULATION OF CELLS.
YOU CAN STILL DO DIFFERENT KINDS
OF CELLS, DIFFERENT TARGETS, SO
YOU CAN DO T-CELLS OR YOU CAN DO
MACROPHAGES. OR OTHER KINDS OF
CELLS. YOU CAN DO CELLS
SPECIFIC DELIVERY OF DIFFERENT
KINDS OF GENETIC MATERIALS AND I
WILL GET INTO HOW. BUT USUALLY
THIS IS GOING TO BE THROUGH BIO
IF HE CAN -- BIO VECTORS OR
USING LIPID NANOPARTICLES AND
YOU CAN DELIVER MRNA OR GENE
EDITING TOOLS OR JUST, YOU KNOW,
LOTS OF DIFFERENT PAYLOADS AND
SIN BIO PEOPLE, YOU CAN PROBABLY
IMAGINE THIS. IT'S LESS
RESOURCE DEMANDING. IT'S LESS
COSTLY. TAKES LESS TIME. SO
THAT MAKES IT MORE EASILY
ACCESSIBLE TO MANY MORE
PATIENTS. SO HOW ARE YOU GOING
TO DELIVER THESE PAYLOADS?
THERE'S TWO DIFFERENT METHODS
USING VECTORS AND ASSOCIATED
VECTORS ARE THE ONES THAT ARE
COMMONLY BEING USED
PRECLINICALLY NOW AND THEN THE
OTHER MAIN TYPE IS SYNTHETIC
NANO CARRIERS AND THIS THESE CAN
BE LIPID NANOPARTICLES.
THEY CAN BEEN NANO VESICALS
THERE'S A VARIETY OF PARTICLES
THAT YOU CAN IMAGINE COULD
COMPLETE THIS GOAL IF TARGETED
TO THE CORRECT CELLS. SO HERE
ON THE BOTTOM LEFT IS A PAPER
FROM JENNIFER'S LAB. USING
ENVELOPE DELIVERY VEHICLES. AND
SO THOSE ARE MEMBRANE-LIKE
VEHICLES BUT THEY HAVE
ANTIBODIES ON THEIR SURFACE THAT
HELPS TARGET THEM SO IN THE
PROOF OF PRINCIPLE EXAMPLE, THEY
DID IN THIS VERY ELEGANT
ARTICLE, THEY TARGETED THE EDVS
TO T-CELLS USING ANTIBODIES AND
ONCE THEY GET IN, THEY ARE
DELIVERING CRISPR REAGENTS AND
THE ANTIGEN RECEPTOR TO CD 19 SO
THEY'RE ACTUALLY DISRUPTING THE
T-CELL RECEPTOR AND THE NEW
CHIMERIC RECEPTOR AND THE T-CELL
ON A T-CELL SURFACE ARE HOME TO
THE CD POSITIVE CANCER CELLS AND
KILL THEM. SO THIS IS ALL
WORKING, YOU KNOW, MAKING SENSE,
WORKING IN MICE, IT'S REALLY ON
THE CUSP OF BEING AVAILABLE FOR
PATIENTS. SO WE THINK THIS IS A
NICE TIME FOR THIS WORKSHOP. SO
THE GOALS ARE TO PRESENT THE
LATEST RESEARCH ON IN VIVO
ENGINEERING OF IMMUNE CELLS,
LOOK AT WHAT ARE THE GAPS. WHAT
ARE THE OPPORTUNITIES. WHAT ARE
THE FUTURE DIRECTIONS, THIS IS
AN EDUCATIONAL OPPORTUNITY FOR
ANYONE, YOU KNOW, IT'S
PREREGISTRATION. WE THINK IT'S
A TIMELY DISCUSSION ON THE
COMPARISONS BETWEEN EX VIVO AND
IN VIVO APPROACHES THE IN VIVO
APPROACHES ARE ALREADY ON GOING,
ALREADY WORKING WHAT DO WE NEED
TO DO IN THE EX VIVO FIELD TO
ACTUALLY BE ABLE TO OFFER THIS
TO PATIENTS NOW. AND THE
INFORMATION AND REGISTRATION
SITE IS LISTED IN THE MIDDLE OF
THE SLIDE THERE BUT IF YOU JUST
GOOGLE AND NCI EVENTS, ALMOST
ANYTHING, ADOPTIVE CELL THERAPY
THE SITE WILL COME UP AND THAT'S
WHERE YOU CAN REGISTER. BUT I
WANT TO JUST BRIEFLY GO THROUGH
THE FOUR SESSIONS. THAT WE'RE
GOING TO HAVE IN THE WORKSHOP.
I'M NOT GOING TO GO THROUGH ALL
OF THE TALKS BUT THE FIRST
SESSION IS ON THE DELIVERY
METHODS I MENTIONED THERE ARE
VIRAL DELIVERY METS AND THE
NANOTECHNOLOGY APPROACHES.
THE TALKS BASICALLY GIVE
EXAMPLES OF WHAT'S GOING ON IN
TERMS OF DIFFERENT METHODS OF
DELIVERY AND WHERE WE ARE WITH
THAT. THE SECOND SESSION
BECAUSE GENOME EDITING
TECHNOLOGY SUCH AS CRISPR ARE
GOING TO BE SO CRITICAL TO SOME
OF THESE DELIVERY METHODS WE'RE
HAVING A SEPARATE SESSION ON
CRISPR TO GO OVER WHAT ALL THE
UP-TO-DATE METHODS ARE, HOW THIS
CAN BE USED FOR INVIVO EDITING
AND ACTUALLY ONE TALK ON INVIVO
EPIGENOME EDITING IN THE THIRD
SESSION WE CALL UPON BEYOND
T-CELLS FOR REPROGRAMMING AND SO
THIS WILL BE DIFFERENT PAYLOADS
AND DIFFERENT KINDS OF CELLS.
SO DIFFERENT PEOPLE ARE LOOKING
AT NK CELLS, LOOKING AT
MACROPHAGES. AND EVEN DENDRITIC
CELLS AND I THINK THE FOURTH
SESSION WILL REALLY BRING
EVERYTHING TOGETHER TO TALK
ABOUT WHERE WE ARE IN TERMS OF
GETTING THESE THINGS INTO THE
CLINIC. AND SO OUR FIRST TALK
IS GOING TO BE FROM TOM
WHITEHEAD AND HE'S THE FATHER OF
EMILY WHITEHEAD I'M NOT SURE IF
YOU HEARD OF HER BUT SHE'S THE
FIRST PEDIATRIC PATIENT TO
RECEIVE CAR-T-CELL THERAPY AND
WOMEN'S HEALTH SHE WAS SEVEN
YEARS OLD AND KNEW SHE'S AN AS
UNDERGRADUATE AT THE UNIVERSITY
OF PENNSYLVANIA AT THE
INSTITUTION CONNECTED TO WHERE
SHE GOT HER CAR-T-CELL THERAPY
AND HER PARENTS START THIS HAD
FOUNDATION TO HELP OTHERS.
AND I HEARD HIM SPEAK HE GETS
TONS OF LETTERS AND E-MAILS FROM
PEOPLE ALL AROUND THE WORLD WHO
ARE DESPERATE TO HAVE THIS
THERAPY FOR THEIR CHILDREN.
HE'LL PROVIDE THIS SORT OF
CONTEXT FOR THE RATIONALE FOR
TRYING TO MOVE THIS FIELD
FORWARD AS QUICKLY AS POSSIBLE.
AND THEN THERE ARE THREE MAJOR
COMPANIES. WHO ARE TRYING TO
MOVE THESE INTO THE CLINIC. SO
THEY'RE EITHER CLOSE OR THEY'RE
THERE. THOSE ARE THE
THERAPEUTICS THAT WE'LL HAVE
REPRESENTATIVES FROM. WE'LL
HAVE A TALK FROM DARIA. THEY
HAD A SOLICITATION TO DEVELOP IN
VIVO CELL THERAPIES SO THAT'S A
REALLY INTERESTING PROGRAM THAT
SHE'LL TALK ABOUT. AND THEN
WE'LL HAVE PETER MARKS FROM THE
FDA TALK ABOUT REGULATORY
CONSIDERATIONS AND AT THE END OF
ALL THE SESSIONS WE'LL HAVE
PANEL DISCUSSIONS AND HOPEFULLY
REALLY TRY TO SYNERGIZE AND TALK
ABOUT HOW TO MOVE THE FIELD
FORWARD. SO THANK YOU FOR
HAVING ME HERE TO TALK ABOUT IT.
AGAIN, THERE'S THE REGISTRATION
WEBSITE. AND I'M HAPPY TO
ANSWER ANY QUESTIONS.
>> ANY QUESTIONS? GREAT. THANK
YOU VERY MUCH.
>> YOU'RE WELCOME.
>> OKAY, THANK YOU TO ALL THE
SPEAKERS TODAY FOR PRESENTING
WHAT THE NIH IS INTERESTED IN
AND TO DR. COHEN FOR WHAT THE
CHANGES IN THE REVIEW PROCESS.
SO WHAT I'D LIKE TO DO IS JUST
WRAP UP I THINK THIS HAS BEEN A
GREAT SERIES OF TALKS FROM
WEDNESDAY'S TRAINING SESSIONS TO
YESTERDAY'S TECHNICAL SESSION TO
TODAY'S OPPORTUNITY SESSION.
WHAT I WILL SAY IS THAT THESE
VIDEOS WILL BE AVAILABLE
SOMETIME IN THE NEXT WEEK OR SO,
ARCHIVED ON A VIDEO CAST AND
THEY'LL BE POSTED ON OUR
SYNTHETIC BIOLOGY CONSORTIUM
WEBSITE SO THAT'S ONE WEBSITE I
WOULD RECOMMEND THAT EVERYONE
BOOKMARKS BECAUSE WE'LL LINK TO
OTHER NIH FUNDING OPPORTUNITIES
ON THE WEBSITES. AGAIN, THANKS
TO THE NIH CONSORTIUM. THE
MEMBERS THAT HELPED WITH PUTTING
THIS ON, THE WORKSHOP STAFF OF
STRATEGIC RESULTS AND THE
NEUROSCIENCES FACILITY AND WITH
THAT I WOULD LIKE TO THANK
EVERYONE FOR THEIR ATTENDANCE
AND SAFE TRAVELS BACK. I THINK
I SAW IT SNOW EARLIER WHICH I'M
NOT USED TO. OKAY, THANK YOU,
EVERYONE. OH, ONE LAST THING IF
YOU HAVEN'T SIGNED OUR POSTER,
PLEASE SIGN OUR POSTER. THIS IS
OUR OLD TRADITION THAT WE'RE
TRYING TO BRING BACK.