WELCOME TO THE 150th MEETING OF THE NATIONAL EYE COUNCIL, A MEASURE OF LONGEVITY, ISN'T IT? WONDERFUL. 50 YEAR ANNIVERSARY THIS YEAR. THREE ADVISOR COUNCILS A YEAR SO WE HAVE 150 TIMES YOU AND PREDECESSORS HAVE MET, THANK YOU FOR BEING HERE. GREATLY APPRECIATE THAT. YOU ARE ABOUT TO DO THE PUBLIC BUSINESS OF THE NATIONAL EYE INSTITUTE. BEFORE PROCEEDING I WOULD LIKE TO RECOGNIZE FOUR OF YOU AS YOUR LAST MEETING HERE. TOM BLAZER, DENNIS LEVI LOU PASQELLI AND SYLVIA SMITH. SORRY. I THOUGHT THAT WAS THE LAST. OKAY. YES, RIGHT. I'M PLEASED TO INFORM YOU ARE APPOINTED FOR A SECOND TERM. SORBRY FOR MY MISSTATEMENT THERE. TWO HAVE TAKEN EARLY LEAVE. SERIOUSLY, THANK YOU. FOR DOING WORK THAT YOU HAVE, IT'S BEEN FASCINATING TO HAVE YOUR VOICES AT THE TABLE. YOU BRING OUTSIDE OPINIONS, IDEA, AND GOOD LIFE, GOOD INTELLECTUAL LIFE TO THE EYE INSTITUTE COMING THREE TIMES A YEAR. THANK YOU VERY MUCH FOR THAT SERVICE. LET ME TELL YOU A FEW THINGS ABOUT WHAT THE EYE INSTITUTE HAS BEEN UP TO. FIRST ON PERSONNEL, WE HAVE HAD SIGNIFICANT CHANGE. SITTING TO MY RIGHT IS DR. -- THE NEW DEPUTY DIRECTOR OF THE EYE INSTITUTE. SHE WAS SELECTED AFTER NATIONAL SEARCH AT THE NIH LEVEL. THE COMMITTEE WAS CHAIRED BY GEORGE KU, DIRECTOR OF NIA, -- NIAAA. SHE'S QUITE FAMILIAR WITH THE EYE SUIT, HAVING FIRST ARRIVED IN 1991 AS A STAFF FELLOW. SENIOR STAFF FELLOW IN THE LABORATORY OF MECHANISMS OF OCULAR DISEASE. COMPLETING THAT SHE WENT TO THE FOUNDATION FIGHTING BLINDNESS AND FOR FIVE YEARS WORKED IN GRANTS PORTFOLIOS ON THE PRIVATE SIDE. THEN RETURNED TO THE EYE INSTITUTE IN 2003 AS ASSISTANT TO ME AS DIRECTOR AND SUBSEQUENTLY BECAME ASSOCIATE DIRECTOR FOR SCIENCE STRATEGIC INITIATIVES AND PROGRAMS. SHE HAS BEEN BOTH IN THE EYE INSTITUTE AT VARIOUS LEVELS AND IN THE OFFICE OF DIRECTOR AND IS QUITE FAMILIAR WITH NUMBER OF PROGRAMS THAT WE HAVE WITH RESPECT TO THE INSTITUTE. THANK YOU FOR ACCEPTING THAT POSITION. ALSO THIS YEAR JUST AS AN ADDENDUM 2018 FRANCIS COLLINS GAVE HER THE NIH DIRECTORS AWARD FOR MENTORSHIP. LET ME ALSO THANK DR. MIKE STEINMETZ. MIKE IS THE DIVISION DIRECTOR OF EXTRAMURAL SCIENCE PROGRAMS AND FOR PERIOD SINCE JANUARY UNTIL JUST WEEKS AGO WAS ACTING DEPUTY DIRECTOR, FULL TIME ROLES IN THE INSTITUTE DOING THAT EXTREMELY WELL AND PRODUCTIVELY FOR ALL OF US AND I WANT TO THANK MIKE STEINMETZ FOR THAT. A WORD ABOUT THE DESP OR EXTRAMURAL SCIENCE PROGRAMS. THIS IS THE MAJOR BOTH MONEY AND INTELLECTUAL PORTFOLIO OF THE EYE INSTITUTE EXTRAMURAL RESEARCH PROGRAM. AS 1200 PLUS OR MINUS ROLE INVESTIGATOR INITIATED RO1s. DR. STEINMETZ BACKGROUND IN VISUAL PROCESSING AND HAS BEEN INSTRUMENTAL WITH THE NIH BRAIN INITIATIVE WHICH IS A VERY MAJOR PROGRAM. ALONG WITH A NUMBER OF THE PROGRAM DIRECTORS WHO -- KNOWLEDGE AND THANKS FOR WORK IN THE (INDISCERNIBLE) ONE OF THE NEWER AREAS IN (INAUDIBLE) HAS A SIGNIFICANT PORTFOLIO IN RESEARCH AND (INAUDIBLE) ACTIVE INTEREST OF BOTH IN BASIC SCIENCE OF VISION RESEARCH AND ALSO OCULAR INJURIES FROM COMBAT. THERE IS A RESOURCE AVAILABLE IN THE DEFENSE DEPARTMENT AND THAT IS NOW BEING COORDINATED TO SOME EXTENT DUE TO INITIATIVES OF DR. STEINMETZ. THANKS TO MIKE FOR SEARCHING AS -- SERVING AS ACTING DEPUTY DIRECTOR FOR A WHILE. ON TO ANOTHER PLEASANT ANNOUNCEMENT. THAT IS AS YOU MAY KNOW, THE 2018 VISION AWARD. WENT TO A GROUP THAT INCLUDED T MIKE REDMAN, ONE OF THE NEI INTRAMURAL INVESTIGATORS. THE AWARD WAS AWARDED FOR THE PATHWAY GOING FROM GENE DISCOVERY THROUGH DELIVERY OF GENE THERAPY IN ANIMALS CULMINATING IN HUMAN OCULAR GENE THERAPY. FIRST REPORTS IN 2008 AND 2009 AND THEN IN DECEMBER 2017 LEADING TO THE DRUG REGISTRATION OF THE FIRST FDA REGISTERED DRUG IN THE UNITED STATES FOR A MONOGENIC DISEASE RETINA OR ANY OTHER MONOGENIC DISEASE, QUITE AN ACCOMPLISHMENT. THE GROUP OF SEVEN RESEARCHERS ACKNOWLEDGED INCLUDE FOUR WHO ARE OR WERE NEI FUNDED, GENE BENNETT, ELLEN MACGUIRE, SAM JACOBSEN AND BILL HEMS WORTH. ONE DEPARTURE, JOBS OPEN, PLEASE APPLY. WE NEED A IT SPECIALIST SURE YOU WOULD QUALIFY WELL. MATT MONTANA HAS BEEN WITH US THREE YEARS, CREATIVE, LED THE INFORMATION OFFICE AT NEI VERY WELL AND HAS UPWARD TO LEVEL OF THE PRESENT TO JOIN OFFICE OF AMERICAN INNOVATION IN EXECUTIVE OFFICE OF THE PRESIDENT. WITHOUT BEING FACETIOUS I'LL SAY THE SAME GOES, FIRST PART OF SUCCESS IS SHOWING UP, HE SHOWED UP AT A COUPLE OF MEETINGS CONDUCTED BY PRESIDENT'S OFFICE, GAVE TALKS, WAS RECOGNIZED AND UNFORTUNATE FOR THE EYE INSTITUTE SELECTED FOR THIS NEW POSITION. SO WE WISHED HIM FAIR WELL AND ARE LOOKING FOR SOMEONE NEW IN THE INFORMATION OFFICE. I MENTION THIS BECAUSE SIGNS INCLUDING VISION SCIENCE IS GOING AS WE KNOW HEAVILY INTO DATA. NIH IS WORKING HARD AT THE NIH LEVEL AND AT THE LEVEL OF EACH INSTITUTES TO BALANCE NEEDS OF SECURE INFORMATION THAT EVERY GOVERNMENT HAS A NEED FOR SECURE INFORMATION VERSUS OPEN INFORMATION. THAT IS THE HALLMARK OF SCIENTIFIC DATA. BUDGETS YOU WILL HEAR FROM KAREN COLBERT IN A MOMENT. THE BUDGET FOR 2018 WAS 772 MILLION. WE ARE UP FROM THAT AT THE MOMENT FOR 2019. I WILL LEAVE DETAILS TO KAREN. ONE THING I MENTIONED LAST COUNCIL MEETING AND WILL REPEAT, BECAUSE IT IS VERY IMPORTANT, CONGRESS CAN AWARD SIGNIFICANT AMOUNTS OF MONEY FOR MEDICAL NEED. THAT IS WHAT THE NIH IS HERE FOR. IN 2018 THERE IS A NEW SUBSTANTIAL POT OF MONEY TOTALLY NEW MONEY. AN INCREASE OF $425 MILLION. AWARDED FOR ALZHEIMER'S RESEARCH. AWARDED TO THE BASE OF THE AGING INSTITUTE. PUT THAT INSTITUTE AT $2.3 BILLION. FROM MID HIGH HUNS OF MILLIONS JUST A FEW YEARS AGO. -- HUNDREDS OF MILLIONS A FEW YEARS AGO. THERE'S INCREASE OF PRECISION MEDICINE FOR THE BRAIN INITIATIVE WHICH LAST YEAR F Y 18 HAD A TOTAL OF ABOUT $430 MILLION TO INVEST IN IDENTIFYING CIRCUITS IN THE BRAIN AND THAT EXTENDS AS WE KNOW INTO THE RETINA. THE RETINA BENEFITED GREATLY, VISION BENEFITED GREATLY FROM THE BRAIN MONEYS. FOR THOSE WHO READ THE ULTRA FINE PRINT, I'M SURE YOU KNOW WHAT THE NON-RECURRING EXPENSE FUND IS. THAT IS A FUND THAT CAN GO PAST PHYSICAL YEAR. NONE RECURRING, ONE TIME BUT IT IS NOT LOCKED INTO THE FISCAL YEAR. UNFORTUNATELY T NIH TOOK A CUT OF $400 MILLION WHICH IS MONEY TO MAINTAIN BUILDINGS BUILD SHELLING SYSTEMS, ET CETERA, ET CETERA, IT FUND, THOSE MONEYS NOW WILL BE APPROPRIATED IN OTHER WAYS, THEY'RE NOT ABANDONED BUT SHIFT IN FUNDING, JUST THOUGHT YOU WOULD WANT TO KNOW THAT. LOAN REPAYMENT PROGRAM, NEERAJ AGARWAL MANAGES THIS. HE WILL TELL YOU DETAILS SHORTLY. THESE FUNDS CAN HELP PHYSICIAN TRAINEES PAY FOR OR REPAY MEDICAL SCHOOL LOANS AND HELP DURING THE TIME THEY ARE PARTICIPATING IN RESEARCH TRAINING. SO IF YOU KNOW OF YOUNG RESIDENTS WHO ARE PARTICULARLY INTERESTED IN FURTHER RESEARCH ACTIVITIES, PLEASE CONTACT NEERAJ AND ASK HIM DETAILS. I WOULD LIKE THE INSTITUTE WOULD LIKE YOUR HELP I WOULD LIKE YOUR HELP WITH RECRUITING IN AREA OF DIVERSITY. THE EYE INSTITUTE HAS A SPECIAL PROGRAM CALLED DIVERSIFY IN RESEARCH AND OPHTHALMOLOGY. IT'S BEEN GOING ON FOR EIGHT YEARS. DURING THAT TIME 65 STUDENTS PARTICIPATED. THEY WORK WITH THE INTRAMURAL NEI LABORATORIES. A NUMBER OF STUDENTS HAVE GONE ON TO PROFESSIONAL MEDICAL OR SCIENCE EDUCATION. WE HAVE HAD HIGH SCHOOL STUDENTS, COLLEGE GRADUATE AND MEDICAL STUDENTS ACROSS A NUMBER OF NATIONALITIES AND RACES. SO THE PERIOD WILL BE OPEN SOON FOR THAT. IF YOU KNOW OF SOMEONE LOOKING TO SPEND A PRODUCTIVE SUMMER ENGAGE IN RESEARCH AND LEARNING ABOUT THE EXCITEMENT OF THAT, PLEASE REFER THEM TO THIS PROGRAM. ANOTHER TOPIC IS STATUS REPORT ON AUDACIOUS GOALS INITIATIVE WHICH STEVE BECKER WILL BE EXPLAINING IN A MOMENT BUT I WOULD LIKE TO TOUCH ON THIS. FIRST WE ARE CALLING THIS THE NEI AUDACIOUS GOALS INITIATIVE. OPPOSED TO THE NCI. THEY HAVEN'T COPIED IT YET BUT THEY HAVE GOTTEN VERY CLOSE. SO IT'S THE NCI AUDACIOUS GOALS INITIATIVE. IT IS LITERALLY IN REGENERATIVE MEDICINE. SO WHEN WE TALK TO A CONGRESSMAN OR SENATOR WE CAN SAY REGENERATIVE MEDICINE. THE NEI AUDACIOUS GOALS INITIATIVE IN REGENERATIVE MEDICINE. TWO MILESTONES I WOULD LIKE TO MENTION. ARE FIRST A WORKSHOP CONDUCTED TWO WEEKS AGO. WITH THE TITLE, PATHWAYS FOR RETINAL CELL REPLACEMENT THERAPIES. RATHER VAGUE TITLE BUT THE MEETING WAS NOT VAGUE. IT WAS VERY POINTED, VERY SPECIFIC, WITH ABOUT 100 PEOPLE WORKING IN THE FIELD, BOTH PRIVATE PUBLIC COMPANY BIOTECH AND GOVERNMENT INCLUDING FDA. IT WAS A DAY AND A HALF MEETING. IT WAS ONE OF THE MOST EXCITING MEETINGS THAT I HAVE SAT THROUGH. IT WAS REMARKABLE. THERE WILL BE A WHITE PAPER COMING OUT OF THIS. WHAT IS REMARKABLE TO ME IS FOUR YEARS AGO THE FIELD DIDN'T EXIST NOW IT DOES. TOPICS THAT FOUR YEARS AGO I FOUND DIFFICULT TO PAY ATTENTION TO BECAUSE THEY WERE SO VAGUE NOW ARE EXTREMELY SPECIFIC. BECAUSE CELLS AND CELL TYPES ARE SPECIFIC ABOUT ENVIRONMENT WHICH THEY CHOOSE TO LIVE. THE CONVERSATION FOR REGENERATIVE MEDICINE USING CELLS IS NOW AT THAT LEVEL. EXTREMELY EXCITING, MOVING QUICKLY. I THINK IT SHOWS HOW FAR WE HAVE COME IN FOUR YEARS BOTH AGI, EYE INSTITUTE, VISION RESEARCH AND SCIENCE AND MEDICAL RESEARCH AS A WHOLE. THE SECOND TOPIC IS ONE YOU KNOW BECAUSE THERE WAS A SPECIAL COUNCIL MEETING BY PHONE A FEW WEEKS AGO TO APPROVE FUNDING OF FIVE PROJECTS I BELIEVE IT IS. DUSTIN, DID YOU CIRCULATE THIS? SO YOU HAVE IT IN FRONT OF YOU. FIVE RESEARCH TEAMS THAT ARE ORGANIZED UNDER A LONG TITLE, TRANSLATING SURVIVALS. THE INTEGRATED REGENERATED NEURONS IN THE VISUAL SYSTEM. WHAT I FIND REMARKABLE ABOUT THIS IS SIMILAR TO THE MEETING THAT WE HAD TWO WEEKS AGO, THIS IS NOW MOVING INTO SPECIFICS. WE'RE NOT TALKING ABOUT WOULDN'T IT BE GREAT IF WE COULD BUT IF FACT WE ARE TALKING ABOUT AT A LEVEL AND THE MONEY IS THERE IN TERMS OF HOW WE WILL TRY THIS. AMONG THE COMPONENTS IMPORTANT FOR THIS, FOR SUCCESSFUL APPLICATION, WE'RE TO HAVE AN ANIMAL MODEL. NOT A GARDEN VARIETY MODEL BUT A MODEL THAT HAD SOME CHARACTERISTIC THAT OVERLAPPED HUMAN DISEASE. THESE PROJECTS ARE NOT INTENDED TO BE PRE-CLINICAL STUDIES BUT THAT'S WHAT THEY ARE IN FACT. PRE-CLINICAL TO GENERATE DATA THAT WILL TOUCHING UP GO TO FDA FOR SUBMISSION OF INDs. THE RULE OF THUMB THAT I WOULD HAVE IS IF WE FUND TEN PROJECTS AND ONE GOES TO FDA WE ARE SUCCESSFUL. MY PREDICTION IS MORE THAN AT LEAST ONE OF THESE FIVE IS GOING TO ACCOMPLISH THAT. OUR SCIENCE WILL BE FAR RICHER FOR WORK THEY ARE DOING. THIS IS THE THIRD INITIATIVE WITH MONEY ATTACHED OF THE AGI. FIRST WAS FUNCTIONAL IMAGING. NOT JUST SHARPER CLEAR IMAGES BUT HOW DOES ONE KNOW THAT WHAT YOU ARE LOOKING AT BEARS SIGNATURE FOR FUNCTION, SOME ASPECT IMPORTANT FOR VISION. OR VISUAL SIGNAL PROCESSING. THE SECOND AREA WAS NEUROMAINTENANCE, BASIC DISCOVERY FOR MOLECULES CRITICAL TO MAINTAIN THE ENVIRONMENT IN WHICH NEURONS CAN GROW AND THRIVE ONCE TRANSPLANTED. SO I'M EXCITED PERSONALLY ABOUT WHERE THE AGI IS HEADED. IT'S HEAD FOR A VERY GOOD COURSE. WE TALKED INTERNALLY ABOUT INTEREST EXPANDING BEYOND WHAT THE AGI IS DOING. IT'S BEEN A GREAT FOR RAY, IT'S BEEN A GOOD WAY TO DO BUSINESS. WE ARE LOOKING AT OTHER NEW WAYS TO DO BUSINESS FOR OTHER ASPECTS OF VISION. THAT COULD BENEFIT FROM THAT. WE WILL HEAR SHORTLY FROM DR.S JENNIFER SUN DAN MARTIN AND ADAM GLASSMAN. ON THE DRCR NETWORK STANDING FOR DIABETIC RETINOPATHY CLINICAL RESEARCH NETWORK, THIS IS DIFFERENT WAY OF DOING BUSINESS. IN THE CLINICAL DOMAIN FOR INTERACTING WITH PATIENTS IT HAS BEEN HIGHLY SUCCESSFUL. IN HAVING MORE THAN 300 PARTICIPATING SITES. WHICH ABOUT 150 CURRENTLY ARE ACTIVE. THAT'S A BIG NUMBER OF SITES. EACH SITES MULTIPLIED BY JUST SEVERAL PATIENTS GETS YOU INTO A THOUSAND AND THAT'S THE SCALE OF NUMBER THAT IT TAKES TO DO HUMAN CLINICAL RESEARCH. AS AN EXAMPLE OF ONE OF THE PROTOCOLS WHICH THERE ARE 28 I THINK, ONE OF THE PROTOCOLS THERE IS SOMETHING CALLED PROTOCOL T, THEY WENT A THROUGH Z AND STARTED OVER, PROTOCOL T IS VERY HIGH IMPACT HUMAN CLINICAL TRIAL PROTOCOL. TO LOOK AT THE POSSIBILITY OF USING ANTI-VEGF COMPOUNDS. FOR DIABETIC MACULAR EDEMA, THE VEGF COMPOUNDS AS YOU WILL REMEMBER ARE TARGETING AGAINST ABNORMAL BLOOD VESSEL GROWTH IN THE ADULT EYE WHICH IS NOT A GOOD THING AND CAUSES VISION LOSS. IT WAS ORIGINALLY DEVELOPED IN THE CONTEXT OF A AND D. BUT THIS PROTOCOL T EXTENDS THE DOMAIN OF THERAPY IN TO DIABETIC MACULAR EDEMA. SO GREAT BENEFIT OF THE MANY PEOPLE IN THIS COUNTRY WHO HAVE THAT CONDITION. WE WILL HEAR FURTHER ABOUT DRCR. JUST ANOTHER WORD BECAUSE THIS WILL INVOLVE YOU DOWN THE ROAD. THAT IS THAT THE NETWORK IS ON A FIVE YEAR GRANT CYCLE. THE RENEWAL IS IN 2019, THIS FISCAL YEAR. A APPLICATION, SUBMITTED APPLICATION EARLY. THAT HAS BEEN REVIEWED VERY WELL. IT WAS SUBMITTED EARLY TO ENABLE SMOOTH TRANSITIONS IN CASE THERE WERE ANY BUMPS. SO THE EYE COUNCIL WILL BE IN THIS. FINALLY AND IN CONCLUSION LET ME MENTION AGAIN NEI 50TH ANNIVERSARY IN THE CALENDAR YEAR 2018. WE HAVE HAD FOUR SYMPOSIA SO FAR. THE MOST RECENT WASSER WAS JUNE ON LOW VISION REHABILITATION. SOME EXCELLENT SPEAKERS. THE FINAL SYMPOSIUM IS NEXT WEEK, THURSDAY. YOU ARE WELCOME TO ATTEND. IT WILL ALSO BE VIDEO AND AVAILABLE ON THE WEB. PRETTY ASTONISHING WHAT HAS BEEN PUT TOGETHER IN FIVE, SIX SPEAKERS, UNDER THE TITLE OF THE FUTURE OF VISION RESEARCH. IT'S HARD TO KNOW WHAT VISION RESEARCH WILL BE DOING 50 YEARS FROM NOW BUT WE HAVE IDEAS ON TRAJECTORIES. THE TRAJECTORIES INCLUDE USING IMAGING MODALITIES, METHODS, TO LOOK AT INDIVIDUAL NEURONS IN THE RETINA. ADAPTIVE OPTICS, ET CETERA. ARTIFICIAL INTELLIGENCE FOR IMAGE ANALYSIS. AARON LEE, THANK YOU FOR VOLUNTEERING YOUR FACULTY MEMBER. WILL BE PRESENTING THIS WITH SOME INTERESTING THINGS SO IF YOU WANT TO HEAR INSIDE STORY TALK TO RUSS AT BREAK HOW THE OPTIC NERVE DIFFERENTIATES MALE FROM FEMALE, STILL PUZZLE, ISN'T IT? BUT MORE IMPORTANT, HOW IMAGE ANALYSIS IS GOING TO MOVE US FORWARD QUICKLY ON THE CLINICAL SIDE IDENTIFYING INDIVIDUALS WHO NEED TREATMENT. CELL TRANSPLANTATION CELL DEVELOPMENT REGENERATIVE MEDICINE, IN OUR INTRAMURAL PROGRAM AND THREE EXCEPTIONALLY INTERESTING NEUROSCIENCE SCIENTISTS, WITH ALL DUE RESPECT, THEY'RE ALL INTERESTING. DORIS SAL, SHEILA NEURONBERG AND SEBASTIAN SUNG. SO AT LEAST LISTEN TO THEIR REPLAY WHEN IT'S ON THE WEB. WITH THAT I WILL CONCLUDE. AND TAKE A MOMENT TO ASK IF THERE'S QUESTIONS ABOUT WHAT I HAVE SPOKEN. HEARING NONE WE WILL PROCEED. >> I BRING YOU TO THE CONSIDERATION OF MINUTES FROM THE JUNE MEETING. WE HAD A COURT REPORTER WHO TRANSCRIBED, SO IT IS A LITERAL TRANSTRANSCRIPTION, THOUGH I'M SURE YOU READ AND REVIEWED YOUR QUOTE, ANYBODY HAVE ANY COMMENTS ABOUT THE MINUTES? MOVE TO ACCEPT. YEAHS, NAYS. THANK YOU. WITH THAT, I THINK WE CAN GO TO LITERALLY ONE OF THE MOST INTERESTING TOPICS OF EVERYBODY, THE BUDGET FOR NEXT YEAR. KAREN COLBERT. >> GOOD MORNING. IT'S A PLEASURE TO BE WITH YOU TODAY. I USUALLY LIKE TO START THESE BUDGET UPDATES TALKING ABOUT THE NEWS THAT'S GOING ON IN THE BUDGET WORLD AND TRADITIONALLY WE ARE TALKING CONTINUING RESOLUTIONS AND THOSE REASONS WHY CONGRESS IS NOT BEEN ABLE TO GIVE US A BUDGET YET BUT FORTUNATELY THIS YEAR WE HAVE AN APPROPRIATION. 'S BEEN TWO DECADES SINCE CONGRESS GAVE US A BUDGET BEFORE OCTOBER 1. LET THAT SINK IN, THAT'S LIFETIME FOR SOME. THOSE WHO HAVE BEEN AROUND THREE MORE DECADES REMEMBER THE TIME WE DID GET BUDGETS ON TIME BUT. THERE YOU HAVE IT. BEFORE YOU GET INTO THE OVERVIEW OF 2019, I LIKE TO GIVE A BRIEF RECAP OF 2018. THIS SLIDE SHOWS THE HISTORY OF NIH AND NEI APPROPRIATIONS SINCE SEQUESTRATION, WE TEND TO LOOK BACK AT SEQUESTRATION BECAUSE THAT WAS A TIME WHEN THERE WAS A SIGNIFICANT REDUCTION TO OUR FUNDING, IT TOOK MANY YEARS FOR US TO RECOVER FROM THAT. WE'RE NOW IN A PERIOD WHERE WE HAVE BEEN RESTORED TO PRE-SEQUESTRATION LEVELS AND FORTUNATELY SINCE 2016 NIH AND NEI HAVE CONSECUTIVELY RECEIVED MODEST INCREASES EACH YEAR. THIS IS A SNAP SHOT OF OUR 2018 SPENDING BY FUNDING MECHANISM. I WILL TELL YOU OUR ACTUAL SPENDING IS NOT REPORTED TO CONGRESS YET. SO WE'RE NOT ABLE TO SHARE THE DETAILS BUT THIS IS A GENERAL OVERVIEW OF WHAT WE SPENT. HI CAN'T TELL YOU THAT IN 2018 WE PUT APPROXIMATELY $20 MILLION MORE INTO OUR RESEARCH PROJECT GRANTS AND RESEARCH GRANTS OVERALL SAW INCREASE OF ABOUT $30 MILLION. WE ALSO MAINTAINED OUR GOAL TO KEEP OUR EXTRAMURAL RESEARCH FUNDING AT 80% OVERALL BUDGET. THIS IS A VISUAL SNAP SHOT OF THE SAME DATA ON THE PREVIOUS SLIDE. OUR GOAL IS TO KEEP EXTRAMURAL RESEARCH 85% BUDGET AND INTEGRAL RESEARCH AT 11% AND RESEARCH SUPPORT AT 4%. THIS IS A HISTORY OF OUR RPG COMPETING RPG SUCCESS RATES. UNFORTUNATELY THE 2018 DATA IS NOT CALCULATED YET BUT I WILL TELL YOU THAT IS OUR EXPECTATION THAT WE WILL STILL REMAIN CONSISTENTLY AT A RATE HIGHER THAN THE NIH AVERAGE. WE TEND TO BE IN THE 25% RANGE. FOR SUCCESS RATE, NIH IS HIGH TEENS. APPROACHING 20%. AND THAT'S OUR GOAL AND WHAT WE EXPECT TO SEE FOR THIS FISCAL YEAR. THIS IS OPERATING LEVELS VERSUS BUYING POWER SLIDE THAT WE LIKE TO SHOW DURING THE BUDGET PRESENTATIONS. IT SHOWS THE IMPACT OF INFLATION ON OUR ABILITY TO SPEND AND AS YOU CAN SEE WE HAVE BEEN WELL BELOW WHERE WE WERE AT THE DOUBLING OF THE NIH BUDGET BETWEEN LATE 1990s AND THE EARLY 2000s ABOUT HALF SO FAR. BUYING POWER. OUTLOOK FOR 2018. FOR THE NATALIE WE RECEIVED AN INCREASE -- FORTUNATELY WE RECEIVED INCREASE WHICH IS FANTASTIC BUT BEFORE CONGRESS DECIDED TO GIVE US A BUDGET INCREASE WE HAD THE PRESIDENT'S BUDGET REQUEST. THAT BUDGET REQUEST SHOWED A PRETTY SIGNIFICANT DECREASE FOR US, ABOUT $16 MILLION OR 2.3% CONGRESS DECIDED TO GIVE AN INCREASE WHICH IS GREAT, APPRECIATE IT. SO THIS IS A SNAP SHOT OF THE HHS NIH AND NEI FUNDING FOR 2018. DEPARTMENT OF HEALTH AND HUMAN SERVICES RECEIVED AD $2.3 BILLION INCREASE. 2 BILLION OF THAT MONEY CAME TO NIH. SO THAT JUST REFLECTS CONGRESS'S CONFIDENCE IN THE RESEARCH THAT WE DO HERE. OF THAT NIH INCREASE OF $2 BILLION NEI RECEIVED 24.2 MILLION OR APPROXIMATELY 3%. THAT IS BEFORE ANY RESCISSIONS OR REDUCTIONS TO OUR BUDGET. WE ARE IN THE PROCESS RIGHT NOW WAITING FOR NIH HHS AND ONB TO TELL US WHAT POLICY REDUCTIONS THEY WILL APPLY TO OUR BUDGET. THIS IS REMINDER OF THE 21st CENTURY CURES ACT AND FINANCIAL COMMITMENT TO THAT PROGRAM. SO FAR CONGRESS HAS HELD TO THIS FUNDING PLAN. WE KNOW THAT FUNDS FOR EACH FISCAL YEAR ARE NOT AVAILABLE UNTIL APPROPRIATED BY CONGRESS, SO FAR CONGRESS HAS HONORED WHAT THEY HAVE SAID THEY WOULD FUND IN THE CURES PLAN. FOR 2019 TOTAL FUNDING OFFER 711 MILLION-DOLLAR. WAS APPROPRIATED. THIS IS A REMINDER WHEN THE CURES FUNDS COME TO NIH THEY GO INTO AN NIH INNOVATION FUND AND THEN THOSE FUNDS ARE THEN DISTRIBUTED TO THE ICEs FOR THE APPROPRIATE PROGRAMS. SO SNAP SHOT OF CURES FUNDING, PRECISION MEDICINE RECEIVED # $6 MILLION INCREASE, BRAIN, $29 MILLION INCREASE, CANCER MOON SHOT $100 MILLION INCREASE AND REGENERATIVE MEDICINE REMAINS FLAT WITH THE FUNDENING TO 18 WHICH WAS $10 MILLION -- 2018 WHICH WAS $10 MILLION. THERE ARE ALSO A NUMBER OF OTHER RESEARCH DIRECTIVES IN THE 209 REPORT LANGUAGE. CONGRESS DIRECTED US TO INCREASE SUPPORT FOR NEW COMPETING GRANTS TO OVER 11,400. SOME PROGRAMS CARRIED OVER FROM 2018. ALZHEIMER'S RESEARCH AND OPIOIDS, ALZHEIMER'S RECEIVED $425 MILLION INCREASE WHICH WENT TO AGING INSTITUTE, AND $500 MILLION TO NIDA AND NINDS. ALSO INCLUDED IN REPORT LANGUAGE IS $200 MILLION BUILDING FACILITIES TO SPEND THAT MONEY. I'M GOING TO STOP HERE AND ANSWER ANY QUESTIONS THAT YOU MIGHT HAVE. >> I WOULD LIKE TO PUT SOME OF THIS IN PERSPECTIVE. NUMBERS THERE'S ALL THE BACK STORY WHAT THE NUMBER MEANS. THIS COMMENT FOUR ASPECTS. 2017, 2018. NIH 2017, WAS UP 6.2%, 6%, NEI WAS UP 2.3%. 2018, LAST YEAR, 8.8% TO 5.4%. SOUNDS RATHER DIRE. TESTIMONY BACK STORY ON THIS IS ONE OF THE LAST SLIDES ON ALZHEIMER'S PRECISION CANCER GENOMICS AND BRAIN. 2017 THOSE ACCOUNTED FOR NOMINALLY $1 BILLION. THIS IS EARMARK MONEY WHICH IS PART OF THE NIH TOTAL T. WHEN IT GETS DOWN TO LEVEL OF INDIVIDUAL INSTITUTES IT LOOKS LIKE NEI DIDN'T DO WELL. PLEASED TO TELL YOU WE DID SUPER MUCH BETTER BUT THE REALITY IS THAT CONGRESS IS EARMARKING MONEYS AND HAS SPECIFIC INTERESTNA ACCOUNTS FOR A MAJOR PART OF THE DIFFERENCE BETWEEN WHAT THE NIH NUMBER ISND THE NEI NUMBER. SECOND POINT THE BUYING POWER IN 2016 WAS EQUIVALENT TO THE YEAR 2000. SO WE HAVE BEEN FLAT FOR 16 YEARS, UP MODESTLY IN 17 AND 18. RIGHT THERE YOU SEE IT. BLUE BARS. 2015, 16 IS ABOUT THE YEAR 2000. SO ACCORDING TO THIS HAVE NOT LOST GROUND BUT WE HAVE NOT GAINED GROUND. AS YOU KNOW, 15, 16 YEARS IN SCIENCE, THERE ARE WHOLE NEW PARADIGMS, NEW WAYS OF DOING BUSINESS, INSTRUMENTATION COST IS UP A LITTLE BIT. BECAUSE WE HAVE NEW INSTRUMENTATION IN HUNDRED HEARSAY THOUSANDS OF DOLLARS SO IN FACT, OUR BUYING POWER IS THE SAME. BUT THE NUMBERS OF GRANTS WE CAN SUPPORT IS DOWN. THIRD POINT, IN 2019, YEAR CURRENT, NIH TOTAL, THIS IS THE THEME OF THE THIRST COMMENT. -- FIRST COMMENT. NIH TOTAL WAS 5.4%, WE LOOK TO GET ABOUT 3%. BUT AS THE NUMBERS SHOW AS KAREN SAID, MONEYS ARE GOING EARMARKED INTO ALZHEIMER'S PRECISION MEDICINE CANCER GENOMICS BRAIN AND THEN YOU MAY HAVE NOTICED THIS IS MY FOURTH POINT, $500 MILLION FOR OPIOIDS. THAT SHOWS IN THE BUDGETS OF NIDA. AND NINDS TO SOME CONSTERNATION BY NIH BECAUSE THESE MONEYS ARE MEANT AS TRANS-NIH AND YET WERE PUT IN THE BASE OF TWO PARTICULAR INSTITUTES. NUMBERS DON'T TELL THE STORY. THERE IS A FLOW OF WHAT'S GOING ON AS COUNCIL MEMBERS I HOPE YOU'RE AWARE OF. BOTTOM LINE I SEE IS LISTEN WE GET TO REGENERATIVE MEDICINE, HUMAN REGENERATIVE MEDICINE, WHEN WE GET TO NHB REGENERATIVE MEDICINE. WE ARE TALKING SUBSTANTIAL COSTS. WE ARE NOT CURRENTLY BUDGETED FOR. TWO WAYS TO HANDLE THAT. TWO WAYS. TAKE FROM WHAT YOU GOT AND PUT IT THERE. WORK. SECOND, GET MORE MONEY. THIRD, DON'T DO IT. THOSE ARE THE CHOICES THAT YOU WILL BE FACED WITH. UNCOMFORTABLE CHOICES BUT WE NEED YOUR HELP WITH IMMEDIATELY BECAUSE WE ARE RIGHT AT THE EDGE OF THE AMOUNT. >> THANK YOU. >> CAN YOU GIVE UPDATE WITH THE EYE BONDS RELATION AND WHERE THAT SITS WITH WAYS OF GETTING MORE MONEY TO SUPPORT INITIATIVE? >> LET ME MENTION THAT, PHONE COUNCIL, I WILL STOP BACK MORE OR LESS AT THE BEGINNING BECAUSE IT'S NOT SOMETHING MOST PEOPLE ARE FAMILIAR WITH. THERE'S BEEN A CONCEPT GENERATED BY ANDREW LO, AT INTERNATIONAL RANK ECONOMIST AT MIT. TO GET PRIVATE MONEYS INTO FUNDING THESE VERY EXPENSIVE NOVEL THERAPIES. THAT WILL BE THE SECOND OPTION OF THE THREE THAT WE HAVE. GET MORE MONEY, THAT WAS TARGETED AT CANCER WHICH IS A BIG PORTFOLIO OF RESEARCH OPPORTUNITY. AND THE MECHANICS THAT NEVER QUITE BEEN ABLE TO BE WORKED OUT. SO HIS EFFORTS OR HIS CONCEPTS HAVE POPPED UP FOR THE FIRST TIME EVER. IN A HOUSE BILL CALLED 6421. LOOK IT UP. WITH A NAME FASTER TREATMENTS AND CURES FOR EYE DISEASE ACT. AND IT WAS INTRODUCED INTO THE HOUSE IN JULY, THE CHAMPION ON THAT WAS PETE SESSIONS, REPUBLICAN TEXAS SANFORD BISHOP DEMOCRAT GEORGIA, BRAD UPTON AND GUS BILAROCUS, NOW IT NEEDS TO GO FOR ACTUAL WRITING, ACTUAL CONSIDERATION, ACTUAL BUDGETING BY THE CONGRESSIONAL BUDGET OFFICE AND BE ULTIMATELY PERHAPS PUT THROUGH A VOTE IN CONGRESS. SINCE THE -- IT WILL HAVE TO BE REINTRODUCED, WITH THE NEW CONGRESS IN 2019. SO THERE IS NOTHING CURRENTLY TO ACT ON BUT IT'S IN THE BACK OFFICES BEING PROCESSED. THE CONCEPT ON THIS. EVERYONE WILL HAVE THEIR OWN OPINION AS TO WHAT THE CONCEPT IS. BECAUSE IT HASN'T FULLY BEEN WRITTEN. THE SCALE IS A BILLION DOLLARS. THE OPERATION OF IT, I'M JUST SWITCHING TO ECONOMICS NOW. THE OPERATION OF THIS IS THIS IS PRIVATE MONEY. BUT IT IS BACKED UP BY GOVERNMENT GUARANTEE. ALL THE GOVERNMENT COULD GUARANTEE HALF OF IT, 500 MILLION OR A THIRD OF IT. 300 MILLION. BUT IT WILL NOT BE GOVERNMENT MONEY BACK BACKING THE WHOLE THING, IT WILL BE FUNDED BY PRIVATE INVESTMENT YOU TOO IF YOU SO CHOOSE CAN BUY AN iBOND DOWN THE ROAD. WHY WOULD YOU DO THAT? BECAUSE IT WILL PAY A RESPECTABLE INTEREST RATE. AND AT THE CONCLUSION OF THE TERM WHICH IS THOUGHT TO BE TEN YEARS, YOU WILL GET YOUR MONEY BACK, JUST A STANDARD BOND. YOU CAN BUY HOUSING BONDS, EDUCATION BONDS, AGRICULTURE BONDS OR YOU CAN BUY iBONDS. THE MONEY NEEDS TO BE INVESTED TO MAKE -- TO PAY BACK, THIS MONEY WILL BE PUT TO COMPANIES SOME OF THOSE COMPANIES WOULD PROSPER. AND SUCCEED. OTHERS WOULD FAIL. FAIL RATE ON THIS KIND OF WORK 50%, 70%, SOMETHING. BUT IT IS COMPANY INVESTMENT AND NOT RESEARCH LABORATORY INVESTMENT AT THE UNIVERSITY OF WASHINGTON. HOW DOES THE EYE INSTITUTE FIT INTO THIS? IT FITS INTO IT AS WE ARE THOUGHT BY PETE SESSIONS AND INSTITUTION SUCH AS FOUNDATION FIGHTING BLINDNESS, TO BE RELIABLE REPUTABLE ADJUDICATOR OF QUALITIES OF SCIENCE. SO THE BILLION DOLLARS WHICH WOULD BE SPLIT UP IN FOUR CHUNKS, 250 MILLION A YEAR. WE WOULD, THE EYE INSTITUTE WOULD PUT OUT A CALL FOR GOOD TRANSLATIONAL SCIENCE IN A COMPANY DOMAIN PRINCIPALLY. WE WOULD LOOK AT THE RESPONSES, RANK THEM BY SURE FIRE TO SURE FAIL, PASS THOSE TO BOND UNDERWRITERS TO MERRILL LYNCH OR OR ANY OF THE WALL STREET FIRMS WHO TAKE THEIR OWN LOOK AT IT. AND THEY WOULD HANDLE THE MONEYS TO GO OUT ON THE STREET. SO OUR INVOLVEMENT IS LIMITED TO ADVISING ON THE QUALITIES OF SCIENCE THAT ARE NEEDED AND I THINK MOSTLY THE QUALITIES THAT ARE SURE TO FAIL. THERE ARE SOME VERY IMPORTANT CONSIDERATIONS ON THAT. IN THE BACK OFFICE WRITING. THAT IS WHO PUTS OUT THE SOLICITATION, WHO PUTS WHO IS RESPONSIBLE FOR HANDLING THE ANNUAL MILESTONE REPORTS. WHO IS RESPONSIBLE FOR PUTTING THE MONEY ON THE STREET AND THE ONE THAT I'M PERSONALLY CONCERNED WITH IS THAT SEEMS TO BE UNDER THE RUG IN THE BACK OFFICE, IS TO WHAT DEGREE WOULD THE EYE INSTITUTE ACQUIRE SUBSTANTIAL LIABILITIES IF THESE BONDS DON'T PAY OFF. AND CONGRESS SAYS OH, WE'RE ON THE HOOK FOR $500 MILLION, I WONDER WHERE WE CAN GET THAT MONEY. THERE ARE LOTS OF DETAILS, IT'S NOT READY FOR THE STREET, THE IS THAT SUBSTITUTION IS THE BILL WILL INFORM OTHERWISE. IT NEEDS TO BE REINTRODUCED BUT IT'S A VERY EXCITING CONCEPT AND SAYS IN CONGRESS THERE IS INTEREST IN VISION AND VISION TRANSLATION. >> QUICK QUESTION ON THE BUDGET. AS WE SEE THE NUMBERS CONCERNING ABOUT THE FLAT GROWTH SINCE 2000, I'M SURE YOU HAVE LOOKED AT IT, I HAVE A HINT THAT, A GUESS ON IT, HAS PRIVATE AND FOUNDATION MONEY FOR EYE RESEARCH, INCREASE COMMENSURATELY DURING THIS PERIOD OF TIME. >> I DON'T KNOW THAT. MY PERSONAL SENSE BUT I HAVE A LIMITED VIEW, IS THERE HAS NOT BEEN A SUBSTANTIAL NEW MONEYS FROM FOUNDATIONS, BENEFACTORS THAT I KNOW OF. NOT ON THE LEVEL OF $100 MILLION WHICH IS WHAT WE'RE MISSING. >> ONE MORE QUESTION ON THE IBONDS, IT'S A COMPLICATED CONCEPT. SO NIH NEI PRESUMABLY HAVE RESPONSIBILITY FOR STUDY SECTION SELECTION OF ESSENTIALLY CORPORATE PROJECTS WITH RESPECT TO SCIENCE BUT IS THE PURVIEW ALSO IN BUSINESS? OR IS IT PURELY SCIENCE BECAUSE IT'S HARD TO DISENTANGLE THE TWO ( >> THAT'S A QUESTION FOR THE OPHTHALMOLOGY DEPARTMENT CHAIR. I DON'T KNOW THE ANSWER NOR DO I KNOW THE MECHANISM, WHAT I DO KNOW IS THAT WE WOULD HAVE NEED FOR ADDITIONAL STAFF TO HANDLE THIS. AND ONE OF CONCERNS AS LEGISLATIVE OFFICE, ONE OF HIS CONCERNS IS THAT THERE IS NO MONEY PUT UP FRONT IN ORDER TO COVER OUR COST BEFORE THE THING GETS GOING. >> THANK YOU. >> NEXT PRESENTATION WILL BE NEERAJ AGARWAL ON THE LOAN REPAYMENT PROGRAM. >> GREAT. GOOD MORNING, SO I'M GOING TO BE TALKING AND GIVE YOU A REPORT ON LOAN REPAYMENT PROGRAMS FOR THE FISCAL YEAR 2018. SO TO BEGIN WITH, WHAT IS THE PURPOSE OF LOAN REPAYMENT PROGRAM? THE PURPOSE IS TO ATTRACT CLINICIAN SCIENTISTS AND OTHER HEALTH PROFESSIONALS TO RESEARCH AND HOW DO WITH DO THAT, WE LURE THEM INTO IT BY PAYING THEIR EDUCATIONAL THAT WHICH THEY INCUR BY BIOMEDICAL TRAINING. SO WHO ARE ELIGIBLE? THEY HAVE TO BE U.S. CITIZENS OR PERMANENT RESIDENTS OR GREEN CARD HOLDERS AND THEY SHOULD BE COMMITTING TO PATIENT ORIENTED CLINICAL RESEARCH AND THEY HAVE TO COMMIT 50% OF THEIR TIME TOWARD THIS EFFORT. SO WHAT NIH WILL PAY IN TURN WILL BE THEIR EDUCATIONAL LOANS BACKED BY THE US GOVERNMENT OR BY OTHER ACCREDITED U.S. ACADEMIC INSTITUTIONS AND OTHER COMMERCIAL LENDERS SUCH AS BANKS. SO WHAT WE DO, WE PAY UP TO $35,000 PER YEAR TOWARD THAT PAY BACK PLUS APPROVED IRS TAXES BECAUSE GOVERNMENT IS GIVING YOU $35,000 SO THEY WANT TO TAX IT SO WE WILL COVER THAT SO YOU DON'T HAVE -- YOU DON'T BE PENALIZED FOR GETTING THOSE $35,000. SO IT COMES AROUND IF YOU ADD THE TAXES WILL BE AROUND $50,000. IT'S RENEWABLE. NIH GRANT SUPPORT IS NOT REQUIRED YOU DON'T HAVE TO HAVE A K GRANT OR RO1 OR R21 OR ANY OTHER -- YOU COMMIT 50% OF YOUR TIME TOWARD CLINICAL PATIENT ORIENTED CLINICAL RESEARCH. IT'S AN ONLINE APPLICATION, RATHER SIMPLE, IT'S PEER REVIEWED SO THOSE APPLICATIONS, THOSE WHO APPLY TO NATIONAL EYE INSTITUTE WE GET THEM AND THEN SROT WILL SEND THEM TO BE PREPREVIEWED BY PEERS. THE DEADLINE IS 2018 THIS YEAR, NOVEMBER 15. SO THIS IS ONCE A YEAR DEADLINE, NOVEMBER 15 EACH YEAR. SO THIS IS THE TABLE TO SHOW YOU HOW MUCH MONEY WE GOT. WE WERE GETTING INCREASE THIS TIME SO WE GOT 1.7 MILLION AND MORE TOWARD NEI LRP BUDGET. WE CALL FUNDING RATES WERE PRETTY GOOD ACTUALLY. NIH AS YOU SEE, SO WE SEE 12 NEW APPLICATIONS, OUT OF THOSE 12 WE FUNDED EIGHT. AND RENEWAL OF THE TYPE 2, 31 AND THEN FUNDED # 1 OUT OF THOSE. 67% WE DID COMPARED TO NIH WHERE WE FUNDED AS A WHOLE 53% SO WE COULD HAVE DONE BETTER ACTUALLY. SOME OF THE APPLICANTS DIDN'T QUALIFY BECAUSE THEIR LOANS WERE NOT IN ORDER OR WHATEVER, OTHERWISE WE WOULD HAVE LIKE AROUND 802% OF THE GRANT. THAT'S ABOUT IT AND IF YOU HAVE ANY QUESTIONS, I WOULD BE HAPPY TO ASK. YES, SIR. >> FROM THAT LAST STATEMENT WE'RE LIMITED -- MONEY IS NOT LIMITING FABTOR. >> MONEY IS NOT THE LIMITING FACTOR. NO. >> WHAT IS THE APPLICATION CONSIST OF? IS IT LIKE A SCIENTIFIC GRANT? >> YEAH, IT IS LIKE A SCIENTIFIC GRANT BUT YOU HAVE YOUR BIO SCAD WHICH IS IMPORTANT AND YOU HAVE TO HAVE A MENTOR IN THE INSTITUTION WHERE YOU ARE APPLYING. SO YOU HAVE TO BE ACADEMIC INSTITUTION OR A NON-PROFIT PLACE IF YOU ARE DOING PRIVATE PRACTICE YOU'RE NOT ELIGIBLE TO DO THAT. THEN YOU HAVE A SCIENTIFIC PROPOSAL, NOT TOO ELABORATE, LIKE TWO OR THREE PAGES, THERE IS NO -- IT'S NOT HIGHLY STRUCTURED YOU DON'T HAVE -- YOU HAVE SIX PAGES FOR YOUR K GRANT, THINGS LIKE THAT. SO THAT AND RECOMMENDATION, THINGS LIKE THAT, SO THAT'S NUMBER ONE AND NUMBER TWO IS SO SINCE OUR KO 8 AND K 33 AWARDEES WE ARE COMMITTED TO 75% TIME FOR RESEARCH, SO AUTOMATICALLY WE ARE ELIGIBLE FOR HIGH CRASS CANDIDATES. FROM (INDISCERNIBLE) SO THEY ARE HA MAJOR. BUT THERE'S NO REQUIREMENT TO HAVE A K OR ANY OTHER NIH GRANT SUPPORT, YOU ARE ELIGIBLE TO APPLY AS SUCH. SO WE HAVE A FEW OF THOSE ALSO. >> IS THERE ANY OUTCOME DATA ON THE RFPs COMPARABLE TO THE K, HOW MANY STAY IN RESEARCH, HOW MANY END UP BEING NIH FUNDED? >> ALL RIGHT. I HAVE -- WE TRIED TO DO FOR -- I MEAN ONE TIME SUCH ANALYSIS. IT'S A FEW YEARS, BUT AS I SAID MAJORITY OF OUR -- RECIPIENTS ARE THE K AWARDEES SO THEY BASICALLY AS I SAID, 55% OF THEM ARE ABLE TO CONVERT TO RO1 WITHIN SIX YEARS OF THEIR GETTING THE K AWARD. AND THE K AWARD IS FIVE YEARS PLUS ADDITIONAL ONE YEAR. SO SOME DO GET THE RO1 FOR THREE YEARS, FOR FOUR YEARS, THINGS LIKE THAT. AS SUCH IN TERMS OF THOSE WHO HAVE NO ANY K AWARD, THAT NUMBER IS NOT -- I DON'T HAVE THAT DATA. YES. >> THE PROGRAM IS EXCELLENT. I'M CURIOUS IF SOMEONE FINISHED A K AWARD, WHAT IS THE ROLE OF THE MENTOR? >> GOOD QUESTION ACTUALLY. SO ONCE YOU ARE ELIGIBLE TO APPLY, THAT'S THE INITIAL APPLICATION YOU STARTED OUT WITH YOUR LOAN. SO THEN IF YOU GO SUBSEQUENT RO1 , WE STILL HAVE TO COME BACK TO APPLY. YOU HAVE THE LOAN TO BE ABLE TO DO THAT. IN TERMS OF MENTORING THAT POINT, IT'S A MOOT POINT BUT WE -- SO FAR INVOLVING RESEARCH, THAT'S ONE OF THE QUALIFYING POINT, YOU HAVE TO BE DOING EVERY MORNING RESEARCH. THAT'S THE THING. ONE MORE THING I FORGOT TO ANSWER THAT SO WE ARE TRYING TO RAISE THE LOAN VALUE FROM 35,000 TO 50,000 A YEAR. IN IS SITTING IN CONGRESS, CONGRESS WILL PAY $50,000 PER YEAR TOWARDS -- AS PROGRAM DIRECTOR, I DON'T KNOW IF YOU HAVE -- INCREASE BUDGET BECAUSE IT GOES THERE AND OTHER MEMBERS -- >> ONLY ONE PROFESSOR. YES. >> >> IT'S TWO YEAR PROGRAM, IS THAT CORRECT? >> IT'S INITIAL TWO YEARS BUT THEN YOU CAN COME BACK. >> LONGER THAN TWO YEARS, NEW APPLICATIONS -- >> YOU START TYPE 2 OR -- >> AS PAUL SAID EARLIER, (INAUDIBLE) IT'S VERY POPULAR ACTUALLY. AND I TALK ABOUT THIS >> HOW MANY YEARS HISTORY DOES THIS PROGRAM HAVE? >> STARTED IN LATE, WHICH STARTED IN 1990s IF I'M NOT WRONG. AM I RIGHT? >> I THINK 25 YEARS. >> 25, YEAH. SO WITH RESPECT TO PEOPLE IN THEIR THIRD AND FOURTH YEAR, RULES WE THEN ADD SEARCH CRITERIA, WE EXPECT TO HAVE CERTAIN PROGRAMS THAT BECOMES PARTS OF THE EVALUATION. SO THE ROLE OF MENTORING VARIES A LOT DEPENDING ON WHAT THAT TRACK IS IF THEY'RE PAID RESEARCH TRACK BUT REAL CLINICIANS THAT MIGHT NEEDS STATISTICS GENETICS SO APPLICATION TYPICALLY HAS THINGS LIKE MENTOR MAY SAY OKAY IN THE FIRST SIX MONTHS THIS PERSON IS GOING TO RUN JOURNAL CLUB. AT THE END OF THE YEAR I EXPECT THEY'LL HAVE A TICK IN ADDITION. IN TWO YEARS I -- TECHNICIAN. IN TWO YEARS I EXPECT A K AWARD. SO YOU SORT OF -- IT'S REALLY THAT MUCH MORE -- FIRST TWO YEAR AWARD, THEN THE ACTUAL RESEARCH PROJECT. YOU WANT TO HAVE AND IN THAT RESEARCH PROJECT WHAT THEY ARE TRYING TO ESTABLISH IS SUBSTANTIVE MEANING IT COULD BE A CAREER PATH, AND THAT THEY ARE THE MENTOR WILL RELINQUISH TO THAT PERSON. SO IN THE FIRST PART IT'S A FUNNY WAY TO KEEP YOU IN RESEARCH BUT IT'S STRUCTURE MORE LIKE THE GRANTS DEMAND. >> IS IT RESTRICTED TO M.D.s? >> NO. >> Ph.D.s ALSO. >> IT'S NOT DESIGNED TO PAY NECESSARILY MEDICAL SCHOOL LOANS BUT UNDERGRADUATE LOANS THAT WEREN'T APPROVED DURING UNDERGRADUATE EDUCATION. >> IT'S YOUR EDUCATIONAL -- EDUCATIONAL DEBT. >> IT'S OPEN FOR Ph.D.s ALSO. >> THANK YOU. >> IF IT'S KINDERGARTEN INTEREST -- SO MY EXPERIENCE IS THAT THE THIRD OF THE AWARDEES ARE Ph.D.s. >> THANK YOU. >> >> NOW STEVE BECKER. >> IT'S MY PLEASURE TO GIVE YOU AN UPDATE ON NEI INITIATIVE AND REGENERATIVE MEDICINE. JUST TO REMIND YOU, OUR AUDACIOUS GOALS INITIATIVE IS 10 TO 15 YEAR EFFORT TO CATALYZE INNOVATION AND VISION RESEARCH. WE HAVE COME UP WITH THE GOAL TO REGENERATE NEURONS AND NEURAL CONNECTIONS IN THE EYE AND VISUAL SYSTEM. AND OUR TARGETS ARE THE PHOTO RECEPTOR CELLS AND RETINAL GANGLIA CELLS. >> THIS IS JUST TO ILLUSTRATE SOME OF THE ACTIVITIES NEI HAS PUT ON IN THE LAST COUPLE OF YEARS. MANY TIMES WE HAVE PUT ON A WORKSHOP IN CONJUNCTION WITH TWO MAJOR MEETINGS, THE ANNUAL MEETING OF THE SOCIETY FOR NEUROSCIENCE, AND THE ANNUAL MEETING OF ARBA. TODAY I WILL BE TELLING YOU ABOUT OUR LATEST MEETING WHICH WAS DONE HERE AT THE NIH CAMPUS TALKING ABOUT PATHWAYS FOR RETINAL CELL REPLACEMENT THERAPIES. AFTER MY PRESENTATION, MY COLLEAGUE TOM GREENWELL WILL DISCUSS MORE ABOUT OUR RECENT AWARDS SHOWN AT THE BOTTOM OF THE BOXES OF RECENT FOAs. SO WE PUT ON THESE WORKSHOPS TO ACCOMPLISH A CUP OF THINGS. WE BRING RESEARCH TOGETHER, RESEARCHERS TOGETHER WITH EXPERTISE TO INFORM US AS WELL AS PROVIDE STATE OF THE SCIENCE BUT ALSO WE FOUND BRINGING PEOPLE TOGETHER PERHAPS NOT SOLELY FROM A PARTICULAR FIELD SPURS COLLABORATION ACROSS FIELDS. AND AN OUTCOME OF THESE WORKSHOPS AS DR. SIEVING MENTIONED IS A WHITE PAPER THAT IDENTIFIES THE SCIENTIFIC BARRIERS, WE ALWAYS WANT TO KEEP IN MIND OUR ULTIMATE GOAL. SO WE PUT TOGETHER A LOT OF THESE INITIAL WORKSHOPS TO AS CERTAIN THE STATE OF THE SCIENCE IN VARIOUS FIELDS. BUT A RECENT WORKSHOP WAS TO BRING THOSE TOGETHER. JUST TO HIGHLIGHT SOME OF THE FOAs WE PUT OUT REMINDING YOU OUR FIRST WAS FUNCTIONAL IMAGING. OUR SECOND ONE WAS TRYING TO IDENTIFY THOSE FACTORS THAT INFLUENCE REGENERATION IN THE VISUAL SYSTEM OUR LATEST ONE WAS ON DEVELOPING NEW MODELS THAT COULD HELP EVALUATE CELL THERAPY STRATEGIES. SO OBJECTIVES FOR THIS LATEST MEETING WERE TO REALLY LEARN WHAT'S NEEDED FOR IND ENABLING STUDIES FOR CELL THERAPY TRIALS. THAT'S WHERE THE FIELD IS RIGHT NOW. THE PREDOMINANT NUMBER OF INVESTIGATORS ARE IN THAT PRE-CLINICAL SPACE. AS YOU KNOW THERE'S A LOT OF RPE CELL THERAPY TRIALS, SO WE WANTED TO SHARE THOSE LESSONS LEARNED FROM THOSE TRIALS AS WELL AS RELATED TRIALS FROM RETINAL PROGENITOR CELLS AND NEURAL STEM CELLS. WE REALLY WANTED TO ALSO GET INTO CONSIDERATIONS FOR DEVELOPING A CELL REPLACEMENT CLINICAL TRIAL. WE ALSO NEEDED TO ADDRESS CHALLENGES TO MANUFACTURING THESE TYPES OF CELLS AND TO INSERTING THEM INTO THE RETINA. WE INVITED FOLKS FROM INDUSTRY AND BIOTECH TO GET THEIR PERSPECTIVES ON THE CHALLENGES THEY SOUGHT FOR RETINAL CELL THERAPY. SO HERE IS AN OVERVIEW OF THE AGENDA, WE HAD SIX SESSIONS AND WE REALLY FROM SOUP TO NUTS COVERED PRE-CLINICAL, CLINICAL REGULATORY SESSION ABOUT DIFFERENT FUNDING OPPORTUNITIES AND THEN OUR SECOND DAY INCLUDED THE CELL MANUFACTURING AND INDUSTRY PERSPECTIVES. SO I WANTED TO LIST THE AFFILIATIONS OF BUNCH OF PARTICIPANTS. WE HAD A LARGE GROUP OBVIOUSLY FROM ACADEMIA. WE HAD A SUBSTANTIAL COHORT FROM BIOTECH AND INDUSTRY AND NOTABLY WE ALSO HAD A LOT OF PARTICIPATION FROM OTHER AGENCIES AS WELL AS INSTITUTES INTERESTED IN THEIR OWN REGENERATIVE MEDICINE PROGRAMS. SO WE'RE STILL COMPILING A REPORT OF THE THIS WORKSHOP BUT WANTED TO GIVE A LITTLE BIT OF INITIAL TAKE AA WAYS. SO IN THE PRE-CLINICAL SESSION THERE'S DISCUSSION ABOUT THE ANIMAL MODELS THAT DIFFERENT GROUPS USE. IT WAS REALLY -- DEPENDING ON YOUR GOAL OF THE STUDY AND WHAT YOUR FOCUSING YOUR RESEARCH YOU CAN USE THEM ACCORDINGLY. KEEPING IN MIND THAT HOW THAT ANIMAL MODEL RELATES TO THE ACTUAL DISEASE PROGRESSION IN THE HUMAN POPULATION IS REALLY IMPORTANT. WHEN YOU ARE FORMULATING YOUR IN STUDIES YOU ORGANIZE YOUR STUDIES INTO CHUNKS THAT ADDRESS DIFFERENT REGULATORY ASPECTS. IT'S NOT POSSIBLE TO DO EVERYTHING AT ONCE BUT TO GO ABOUT IT IN A METHODICAL WAY BY INTERACTING WITH YOUR COLLEAGUES THAT TRAVELED THAT PATH AS WELL AS THE FDA. WE LEARN AD LITTLE BIT ABOUT WAYS TO INTERACT WITH THAT. FROM THERE'S A LOT OF TALK ABOUT END POINTS AND FIGURING WHAT'S SUITABLE DEPENDS ON YOUR DISEASE YOU ARE STUDYING AND WITH YOUR CELL THERAPY. SO THERE WAS A SUGGESTION WE NEED SOME MORE LONGITUDINAL STUDIES TO IDENTIFY BIOMARKERS SO WE CAN REALLY UNDERSTAND THE DISEASE PROGRESSION WITH SOME VALIDATED ATTRIBUTES. THE REGULATORY SESSION HAD THREE DIFFERENT PERSPECTIVES. WE HAD SOMEONE FROM THE CELL MANUFACTURING INDUSTRY CALLED BIOFAB USA WHICH IS FUNDED BY DOD. WE HAD SOMEONE FROM BIOTECH BLUE ROCK THERAPEUTICS. WE HAD FDA ONE OF THE MAIN THINGS THAT WAS EMPHASIZED WAS THAT WITH NEW REGENERATIVE MEDICINE DESIGNATION THAT ACCELERATES YOUR ABILITY TO GO THROUGH THE TRIAL WE NEED TO FIGURE OUT CELL MANUFACTURING EARLY. THAT MEANS LIKE PHASE 2 WE NEED TO KNOW IN PLACE ALL THE QUALITIES OF YOUR PRODUCT AND PROCESS OF MAKING IT. SO THE MORE COMPLEXITY OF YOUR CELL PRODUCT IF ON SCAFFOLD, THINGS LIKE THAT, HAVE TO BE TAKEN IN CONSIDERATION REALLY EARLY ON. SOME OF THE PEOPLE THAT WE INVITED ARE INVOLVED IN THAT SPACE, THROUGH DIFFERENT FUNDING AGENCIES, I MENTION THE DOD HAS THIS BIOFAB USA THAT'S BEEN AROUND ABOUT A YEAR, THERE'S A DEPARTMENT OF COMMERCE GROUP CALLED NIMBLE THAT IS ALSO IN COMMERCIALIZING PRODUCTS USED FOR CELL THERAPIES. AT THE END OF THE FIRST DAY, WE GAVE AN OVERVIEW ABOUT NIH REGENERATIVE MEDICINE INNOVATION PROJECT WHICH HAS $28 MILLION IN FUNDING THE NEXT THREE YEARS. REALLY TO ADVANCE THOSE PROJECTS THAT ARE POISED FOR CLINICAL TRANSLATION WITH THE UO 1 MECHANISM OR ONES THAT WANT TO CONDUCT CLINICAL TRIAL. WE HAD C,RM PRESENT SUBSTANTIAL MONEY FOR THE NEXT TWO YEARS TO SUPPORT AWARDS AND THEIR FOCUS IS REALLY ON SUPPORTING CLINICAL TRIALS IN TRANSLATING PROMISE MANAGE THERAPIES. AS I MENTIONED BEFORE, TWO NEW MANUFACTURING ENTITIES ARE NOW ISSUING PROJECT CALLS AND WHAT'S UNIQUE ABOUT THEM IS THEIR CONSTITUENTS ARE INDUSTRY. SO A PROPOSAL IS PRESENTED BY ACADEMIC RESEARCHER OR BIOTECH COMPANY AND IF THERE'S INTEREST FROM INDUSTRY THEY PICK IT UP BASICALLY. IT'S A CROSS CUTTING TECHNOLOGY OR PLATFORM THAT CAN REALLY ADVANCE REGENERATIVE MEDICINE. ACROSS MANY FIELDS. SO WE HAVE A CELL MANUFACTURING SESSION WHICH DETAIL AD LOT OF CHALLENGES IN THE PROCESS. WE DON'T HAVE A LOT OF EXPERIENCE SO THERE'S NOT A LOT OF UNDERSTANDING HOW DIFFERENT TWEAKS IN THAT PROCESS LINE AFFECTS THE FINAL PRODUCT. FOR EQUIPMENT LOT OF PEOPLE ACT DELLICS FOUND THEY NEED TO KNOW ABOUT WHAT'S GOING ON WHEN THEY ARE MAKING THEIR CELL PRODUCT, WHAT ARE ALL THE SPECIFICATIONS FOR ALL COMPONENT PARTS USED AND HOW COULD THAT AFFECT THE FINAL PURITY OR CONTAMINATION OF THEIR PRODUCT. AND REAGENTS, THEY NEED TO BE VALIDATED AND QUALIFIED FOR USE. SO OUR FINAL SESSION WAS QUITE INTERESTING WITH INDUSTRY REPRESENTATIVES. WHAT I TOOK AWAY WAS THAT A LOT ARE INTERESTED IN CONTINUING THE DIALOGUE THROUGH MEETINGS AND ALSO THROUGH INFORMAL DISCUSSIONS WITH ACADEMIC AND BIOTECH COMPANIES. MAJOR THINGS THEY ARE TRYING TO ADDRESS IS REIMBURSEMENT. ALL THESE THERAPIES HAVE A HEFTY PRICE TAG AND WE NEED NOVEL REIMBURSEMENT STRATEGIES TO MAKE IT A SUCCESSFUL BUSINESS MODEL. THEN MAJOR CHALLENGES THEY IDENTIFIED WERE LACK OF GOOD ANIMAL MODEL, LACK OF KNOWING HOW TO DESIGN A TRIAL BOTH FOR SAFETY AND EFFICACY. AND ONE OF THE DRIVERS THAT IS A LACK OF BIOMARKERS WHICH I MENTIONED BEFORE. THEY GAVE A COUPLE OF EXAMPLES WHERE COLLABORATIVE RELATIONSHIPS WITH ACADEMIC CENTER OR SMALL BIOTECH AUTHORED -- OFFERED A FASTER PATH TO THE MARKET. THAT COULD BE SEEN RECENT GENE THERAPY. GENETIC MANIPULATION AND GENE THERAPIES THAT COME TO MARKET. AND THERE WAS INTERESTING EXAMPLE OF HOW JUST SIMPLE DISTRIBUTION OF A CELL PRODUCT CAN BE A MAJOR HURDLE. ONE GROUP MENTIONED THAT A -- JUST HAVING A MINUS 70 FREEZER ON SITE AT DIFFERENT PLACES WHERE YOU WANT TO DELIVER THAT CELL PRODUCT -- PATIENT CLINIC SETTING. IS A REAL LOGISTICAL HURDLE THEY HAVEN'T FULLY CONSIDERED SUPPLY CHAIN TO ADDRESS. HOPEFULLY THESE THINGS WILL APPEAR SHORTLY ON OUR WEBSITE AND ALSO THOROUGHLY THROUGH COUPLE OF PUBLICATIONS. TURNING TO A COUPLE OF ACTIVITIES, HI IS COMING UP IS REGULAR PRINCIPLE INVESTIGATOR MEETINGS. WE HAVE FUNCTIONAL IMAGING CONSORTIUM MEETING NOVEMBER AND REGENERATIVE FACTORS CONSORTIUM MEETING IN DECEMBER. JUST TO REMIND EVERYBODY THE PURPOSE OF THOSE MEETINGS ARE TO REVIEW MILESTONES, SHARE RESULTS DISCUSS CHALLENGES, COLLABORATION AND REALLY IMPORTANT ASPECT IS WE BRING IN EXTERNAL EXPERTS IN THE FORM OF OVERSIGHT COMMITTEE AND THEY ARE REALLY SEEN AS COLLABORATORS IN THESE PROJECTS TO HELP ADDRESS ANY HURDLES THAT NEED TO BE OVERCOME. JUST TO REMIND YOU COUPLE OF THESE PROPROJECTS WE HAVE FIVE IMAGING AWARDS, I WON'T GO INTO THE DESCRIPTIONS NOW. BUT AT THE END OF MY PRESENTATION WE CAN TALK ABOUT OUR DIFFERENT SYMPOSIUM ACTIVITIES AND HOW TO HIGHLIGHT DISSEMINATE INFORMATION COMING OUT OF THESE CONSORTIUM. FOR REGENERATION FACTORS WE HAVE SIX DIFFERENT PROJECT USING A VARIETY OF ANIMAL MODELS AND APPROACHES TO DISCOVER NOVEL FACTORS THAT CAN INFLUENCE REGENERATION IN THE VISUAL SYSTEM. WE ARE CURRENTLY DEVELOPING A SYMPOSIUM AT THE NEXT ARVO. OUR THOUGHTS ARE TO HIGHLIGHT HOW THE FUNCTIONAL IMAGING TECHNOLGIES THAT WE'RE SUPPORTING AS WELL AS PERHAPS OTHERS IN THE FIELD COULD SUPPORT CELL THERAPY EFFORTS. WE'RE ALSO AFTER TALKING WITH OUR STEERING COMMITTEE, WE'RE INTERESTED IN HAVING A SYMPOSIUM NEXT YEAR'S SITE FOR NEURO-- SOCIETY FOR NEUROSCIENCE, WE'RE STILL NOT SURE OF THE TOPICS BUT IT CAME UP THAT WE CAN SHOWCASE ADVANCES IN RETINAL ORGANOIDS AS WELL AS RETINAL NEURON CHARACTERIZATIONS. TRY TO TIE IN HOW THAT KNOWLEDGE CAN INFORM CELL REPLACEMENT THERAPIES. THAT'S ALL I HAVE, HAPPY TO TAKE QUESTIONS AND OPEN FOR DISCUSSION. DR. VAN GELDER WAS T AT OUR WORKSHOP. IF YOU HAVE ANY COMMENTS, WELCOME. >> IT WAS VERY IMPRESSIVE WORKSHOP, VERY LARGE NUMBER OF PARTICIPANTS COVERING A BROAD SPECTRUM IN THE FIELD AS SOMEONE WHO IS AWARE OF WHAT'S HAPPENING BUT NOT IN THE TRENCHES, I LEARNED ADVANCES IN ORGANOID BIOLOGY WERE REALLY IMPRESSIVE, THE RANGE OF CELL TYPES THAT ARE GENERATED IN ORGANOIDS THAT THE ORGANIZATION OF THE ORGANOIDS THAT IT WAS A REAL VERY IMPRESSIVE, IT'S ALSO CLEAR WE'RE MOVING IN PARALLEL ON MANY LINES AND BASIC SCIENCE IS NOT AT THE POINT WHERE IT'S SO MATURE THAT WORK THERE IS DONE, THERE'S STILL A LOT OF BASIC SCIENCE LEFT TO DO. ONE ISSUE THAT CAME UP, NEAR TO MY HEART IS DISCUSSION ABOUT IMMUNE REJECTION AND THE IMMUNOLOGY OF CELL BASED THERAPY WHICH I THINK NEEDS TO BE ADDRESSED TO MOVE FORWARD IT'S NOT CLEAR THE BIOLOGY IS UNDERSTAND AND MECHANISMS FOR SUPPRESSING IMMUNE REACTION TO ALLOGENEIC TRANSPLANT IS FAR ENOUGH ALONG THAT ONE COULD SLIDE INTO CLINICAL TRIALS WITHOUT WORRYING ABOUT THAT ASPECT. THE REGULATORY, I HAVE TO SAY IS EXTREMELY DAUNTING AND IT IS VERY COMPLEX SPACE. THE DECISION NATION HAS ANOTHER LEVEL OF COMPLEXITY NOT SO MUCH SCIENTIFIC STANDPOINT BUT PRACTICAL STANDPOINT THE R MAT IS FAST TRACK TO FDA APPROVAL WHERE CERTAINLY YOUR PHASE 1, 2 DATA CAN BE USED FOR YOUR ENABLING IND STUDY. AS STEVE ALLUDED TO, WHAT THAT BASICALLY MEANS IS COMPANY IS GOING TO THE SPACE HAVE TO MAKE A BIG BET ON THE FAST TRACK THAT THEY HAVE TO RAMP UP PRODUCTION TO HAVE CELL BASED THERAPY TO PURSUE TO QUALIFY THE BATCH THAT GETS MADE OF THE CELLS AT THEIR PHASE 1, 2 STAGE WHICH IS OFTEN EARLIER THAN TRADITIONALLY ONE HAS TO DO THIS. I THINK THAT'S GOING TO IMPACT THE FIELD AND THE WHOLE TENOR OF THE FIELD BECAUSE IT CHANGES SOME OF THIS INTO LARGE TERRITORY FOR THE COMPANIES IN SPACE. TO FEEL ASSURED LIKELIHOOD SUCCESS IS HIGH AT EARLY STAGE AND AGAIN THAT'S GOING TO COME BACK TO TO NEEDING MORE DON VINCEING PRE-CLINICAL EVIDENCE AND IN PARTICULAR LARGE ANIMAL MODELS AND THINGS LIKE THAT BEFORE THE POINT OF THE THIRD ROUND OF THE RFPs. OVERALL IT WAS STUNNING HOW MUCH ACTIVITY IN THE SPACE,, IT WAS REMARKABLE HOW MUCH INDUSTRIAL INTEREST THERE IS, OBVIOUSLY THIS IS SPAWNED BY AGI, WE WOULDN'T HAVE THIS TOWN HALL OR LEVEL OF DISCOURSE, SO IT WAS A VERY EXCITING MEETING BUT OUTLINED THERE'S QUITE A LOT OF WORK LEFT TO DO BEFORE READY FOR PRIME TIME. >> I WOULD LIKE TO RECEIVE THE PROGRAM DIRECTORS WHO ARE INVESTING A LOT OF ENERGY AND TIME IN MAKING THIS HAPPEN. >> I'M TOM GREENWELL, PROGRAM DIRECTOR HERE AT THE NATIONAL EYE INSTITUTE. I WILL TALK ABOUT THE LATEST FOA THAT WAS RELEASED LAST YEAR AND FUNDED FIVE GRANTS, A LITTLE BIT ABOUT THAT, AND ALSO TALK ABOUT A CONCEPT CLEARANCE BASED ON SOME OF THE INFORMATION THAT WE GATHER. SO NOT TO BELABOR THE FOA BUT WE WANTED TO -- IT IS A LONG TITLE, AS DR. SIEVING ALLUDED TO EARLIER, TRANSLATION ENABLING MODELS TO EVALUATE SURVIVAL AND INTEGRATION REGENERATED NEURONS IN THE VISUAL SYSTEM AND FOLLOWS THE OTHER TWO FOAs THAT WERE RELEASED PREVIOUS YEARS, THE FIRST FOCUSING ON FUNCTIONAL IMAGING AND THE SECOND FOCUSING ON REGENERATIVE FACTORS AND COAXING THE BIOLOGY OF REGENERATION. SO WE THOUGHT THE THIRD FOA WOULD HELP INTEGRATE SOME OF THOSE ASPECTS. REALLY TRY TO PUSH TOWARDS PRE-CLINICAL AND TRANSLATIONAL WORK, SO WE CONTINUED THAT MOMENTUM, WE ALSO BIG HALLMARK OF AUDACIOUS GOALS AND REGENERATIVE MEDICINE IS IT IS MULTI-PI TEAM SCIENCE, IT DOESN'T TAKE ONE PERSON WORKING AT A LAB BENCH, IT TAKES COLLABORATIONS CROSS CUTTING WORK MULTIPLE DISCIPLINES SO WITH GOAL THERE WERE THREE GOALS TO THE FOA. FIRST IS TO GENERATE MODELS THAT MORE CLOSELY RECAPITULATE HUMAN DISEASE AND OPEN UP FOR REGENERATIVE MEDICINE THERAPIES AND APPROACHES. SECOND WAS TO CREATE A MODEL THAT RESEMBLED THE ANATOMY AND PHYSIOLOGY OF THE HUMAN RETINA SUCH AS VERY CONE RICH ENVIRONMENT AND THIRD WAS TO BE ABLE TO TEST THAT FUNCTIONAL INTEGRATION AND ASSESS VISUAL IMPROVEMENT. FOA PUBLISHED LAST YEAR AT THE END OF LAST YEAR, DECEMBER 7, 2017. THERE IS A APPLICATION RECEIPT DATE IN MARCH OF 2018. THE APPLICATIONS WERE VIEWED IN HOUSE HERE AT NATIONAL EYE INSTITUTE BY OUR EXCELLENT SRO AND REVIEW CHIEF DR. ANN SHAFFNER, THAT WAS A DAUNTING TASK TO PUT TOGETHER COMPREHENSIVE GROUP OF EXPERTS THAT COULD REVIEW SUCH LARGE APPLICATIONS AND 30 PAGES BASICALLY TO PUT TOGETHER THEIR APPLICATION. SO THERE'S A LOT OF READING AND A LOT OF DIFFERENT EXPERTISE TO BEAR IN THESE APPLICATIONS IS A GOOD GUESS. THE APPLICATIONS, COUNCIL KNOWS, CAME THROUGH CLOSED SESSION IN AUGUST OF 2018 VIA PHONE CALL. YOU VETTED OUR PROPOSALS FOR FUNDING THERE THROUGH YOU AND AGAIN AS WAS SAID EARLIER TODAY WE MADE FIVE AWARDS IN FISCAL YEAR 2018 JUST THE END BEFORE THE DOOR CLOSED GOT THESE OUT THE DOOR AND OVER NINE INSTITUTIONS RECEIVED FUNDS INCLUDING PIs AND SUBAWARDS, SO IT WAS CROSS CUTTING AND A LOT OF DIFFERENT GROUPS. I'LL GET INTO THE DETAILS, FIRST GROUP IN ALPHABETICAL ORDER, DOES NOT REFLECT SCORE ORDER OR MERITORIOUSNESS. THEY WERE ALL MERITORIOUS. IT WAS A PRESS RELEASE TODAY THAT DESCRIBES THE GROUPS AS WELL. IN GOOD DETAIL. SO THE FIRST GROUP WAS FROM JOE CAROL AND JACKIE DUNCAN,, WISCONSIN, UCSF AND ALSO OSH KOSH, WISCONSIN AND THEY'RE DEVELOPING CONE DOMINANT RETINAL DISEASE MODELS AS A RESOURCE FOR TRANSLATIONAL VISION RESEARCH, AND WHAT THEY'RE REALLY DOING IS LOOKING AT CONE DISEASES AND INCREASING IMAGING AND CELL THERAPY APPROACHES IN THIS WAY, BEING ABLE TO LOOK AT CELLS AND HOW THEY INTEGRATE IN THE MODEL AND HOPEFULLY GET SOME SUCCESS FOR RETINAL DISEASE. THE SECOND GROUP WAS BY DR. GOLDBERG AT STANFORD, DR. HAWKINS AT VANDERBILT, DR. RAY UNIVERSITY OF WASHINGTON AND DR. ZACK AT HOPKINS. THEY ARE WORKING ON OPTIC NEUROPATHY MODELS IN MODELS OF DISEASE, THEY ARE REPLACING CELLS IN THOSE MODELS AND ASSESSING FUNCTION THROUGH PUPILLARY REFLEXES AND ELECTRORETINAL GRAMS AND MAKING SURE VISUAL FUNCTION IS GOING FORWARD. THIRD PROJECT IS AN ORGANOID APPROACH PROJECT BY DR. REX AT VANDERBILT, DR. SAMUELS AT UAB AND DR. BARINOF AT MASS -- AND THEY ARE WORKING ON TWO MODELS OF OPTIC NEUROPATHY, VISUAL TRAUMA AND OTHER ONE BEING HYPERTENSION AND REPLACING RETINAL GANGLION CELLS IN THOSE MODELS. THEN THE FOURTH PROJECT IS BY -- HEADED BY DR. ROGERS AT BAILOR COLLEGE OF MEDICINE, AS WELL AS DR. ROY CHEN AND DR. STOT WITH COLLABORATORS AT UC DAVIS. THEY ARE WORKING ON MODEL SYSTEMS FOR NATURALLY OCCURRING CONE DISEASE OR RETINAL DISEASE IN THE POPULATION AND REPLACING THOSE PHOTO RECEPTOR CELLS TESTING AND INTEGRATION AND FUNCTION THROUGH THOSE METHODS. THE FIFTH PROJECT, I'M ACTUALLY THE PROGRAM OFFICER ON THAT ONE. WE HAVE THREE OTHER PROGRAM OFFICERS INVOLVED. IN THESE PROJECTS AS WELL. SO APPRECIATE THE HELP, NOT JUST ME, JUST GOT PICKED TO GIVE THIS TALK BUT THIS GROUP IS BY THE CHILDREN'S HOSPITAL OF PENNSYLVANIA. UPENN AND DR. GANN AT WISCONSIN TO DEVELOP NOVEL RETINAL DISEASE MODELS THROUGH PHYSICAL GENETIC MEANS AND REPLACE PHOTO RECEPTORS. AGAIN, TEST FUNCTION THROUGH VISUAL ACUITY TASKS AND ERG. VERY COMPREHENSIVE GROUP HERE. THERE IS A LOT OF OPPORTUNITIES FOR SYNERGIES AND COLLABORATION. THE DOCTOR REX GROUP FOR EXAMPLE IN THE GROUP ARE USING A SIMILAR MODEL MAKE THEM LEARN QUITE A BIT FROM EACH OTHER BECAUSE THEY ARE USING THE SAME MODEL, THEY ARE USING DIFFERENT APPROACHES. DR. CAROL IS MORE FROM THE IMAGING TECHNOLOGY APPROACH AND IMPROVEMENT AND DR. -- AND THE CONE DISEASES AND DR. REX IS LOOKING AT GLAUCOMA RELATED OPTIC NEUROPATHY DISEASE AND MORE OF THE ORGANOID APPROACH. SO THERE'S SYNERGY, THERE'S JUST ONE HIGHLIGHT. THERE'S MODELS THAT ARE INNOVATIVE. VERY NEW NOT REALLY SEEN IN THE FIELD BEFORE THESE GROUPS DEVELOP IN THE FIRST COUPLE OF YEARS THESE PROJECTS FOR CONE DYSTROPHY, GLAUCOMA, HERITABLE RETINAL DISEASE, VISUAL TRAUMA, ET CETERA. THE SECOND POINT IS THAT THERE'S A DIFFERENT APPROACHES TO ACTUALLY PUT THE CELLS IN TO THESE MODELS. SO THE GROUPS CAN TALK TO EACH OTHER AND FIGURE OUT WHAT WORKS BEST FROM ONE GROUP APPROACH TO THE OTHER GROUP'S APPROACH. VERY EXCITING. AND THEN THE THIRD AGAIN, THIRD ASPECT IS REALLY EVALUATING THIS INTEGRATION AND FUNCTION IN NEW WAYS. USING STANDARD METHODS SUCH AS ERG AS WELL AS NOVEL IMAGING METHODS SUCH AS ADAPTIVE OPTICS SCANNING LASER I CAN NEVER SAY -- OPTHOLMOOSCOPY. THE RFA IS AT THE BOTTOM, I TALK ABOUT THE TITLES VERY LONG. WE HAVE ALSO PUT TOGETHER JUST LIKE THE OTHER FOAs AND CONSORTIUM, WE HAVE AN EXTERNAL SCIENTIFIC OVERSIGHT COMMITTEE. I'M HAPPY TO SAY I FINISHED TALKING TO THE GROUP LAST WEEK AND PUTTING THEM TOGETHER AND VOLUNTEERED, DR. KLEGG UNIVERSITY OF CALIFORNIA SANGEETA BARBARA. HAS STEM CELL BIOLOGY, PRE-REGULATORY EXPERTISE,HE WAS AT THE RECENT WORKSHOP THAT DR. BECKER MENTIONED, HE'S FUNDED. REALLY GOING TO BRING A LOT OF PRE-REGULATORY AND EXPERIENCE FROM REGENERATIVE MEDICINE TO THIS GROUP AS WELL AS DR. HOOD WHO IS AT COLUMBIA HAS IMAGING AND FUNCTIONAL EXPERTISE WHEN I TALKED TO HIM HE WAS HAPPEN MYOPY -- HAPPY TO HELP INSTITUTE. DR. WAHL LAS WHO IS ONE OF THE PROPONENTS OF PHOTO RECEPTOR BIOLOGY AND WHAT'S HAPPENING WHEN YOU PUT PHOTO RECEPTOR STEM CELLS INTO THE RETINA. SO THAT EXPERTISE ADDS TO SYNERGIES AS WELL AND CLINICAL EXPERIENCE FROM DR. SCHWARZ UNIVERSITY OF CALIFORNIA LOS ANGELES. WE ARE STARTING WITH THESE FOUR FOLKS, SHOULD BE A GOOD GROUP, WE ARE HOPING TO HAVE A MEETING IN THE FALL OR WINTER, IT WILL BE HARD TO GET EVERYONE TOGETHER WITH THEIR BUSY SCHEDULES BUT THAT'S THE NEXT GOAL. THE THREE GOALS ARE TO GET EVERYONE FAMILIAR WITH EACH OTHER, WITH THE PROJECTS, AND THEN TO AGREE UPON MILESTONES TO GET THINGS GOING. THE THIRD IS FOSTER COLLABORATION WHICH I MENTIONED, A LOT OF SYNERGY. WHAT I'M ALSO HERE FOR IS A CONCEPT CLEARANCE, WE LEARNED FROM THE LAST FOA THAT WE DID, THAT THERE WERE SOME PROJECTS THERE THAT WERE GOOD IDEAS BUT NOT FULLY DEVELOPED, THEY NEEDED MORE TIME, THEY NEED MORE THOUGHT MORE MONEY TO PUT TOGETHER THESE MODEL AND GET PRELIMINARY DATA IN SO WE KNEW THE TIME FROM PUBLICATION FROM DECEMBER TO MARCH, MIGHT NOT HAVE BEEN ENOUGH TO PUT TEAMS TOGETHER AND REALLY FULLY DEVELOP AN APPLICATION. WHAT WE WANT TO DO NEXT IS A SMALL SCALE FOA FOR SHORT TERM WORK TO GET THESE MODELS DEVELOPED MORE. FROM IDEA TO BENCH. THAT WOULD PRODUCE A BROADER BASE. BASIC BIOLOGY FOR PEOPLE TO COME IN FOR FUTURE PROJECTS. THAT'S THE GOAL THAT IS WHAT I'M HERE FOR, HOPING COUNCIL APPROVES THIS CONCEPT CLEARANCE. DR. SHEEHY, DO WE VOTE ON THIS? >> ANY COMMENTS FIRST. I'M AHEAD OF THE GAME HERE. DR. MASON, YES. >> IT'S A TERRIFIC IDEA. AN R-21 APPROACH. >> NOT THE GET INTO THE WEEDS, BUT IT WOULD BE TYPE R-21 TYPE TWO YEARS SEED MONEY AND SPREAD SEEDS WIDELY TO FUND DOZEN OR SO PROJECTS, HIGH SUCCESS RATE OF WHAT PEOPLE COME IN AND FOR A LOT OF MONEY OVERALL. >> TOM REVIEWED THE TIME LINE. SO WE ISSUED THE PREVIOUS RFA IN DECEMBER WHICH IS EARLY IN THE YEAR, MARCH REVIEW MARCH RECEIPT DEADLINE WE STILL ONLY GOT IN BY VIRTUAL COUNCIL IN AUGUST. SO THE IDEA IS TO PROVIDE TIME AND SUPPORT TO COME IN WITH MORE SUBSTANTIVE CHARACTERIZATIONS OF MODELS. AMOUNT OF SUPPORT OF TIME SORED IN THAT APP. IT'S SMALL SCALE BECAUSE WANT THESE AWARDS TO GO OUT SO WE KEEP MOMENTUM, IF THEY HAVE NO AWARD THIS CLEAR IT THAT MEANS THEY DON'T PUT AN APPLICATION UNTIL NEXT YEAR SO THAT WILL BE TWO YEARS BEFORE THEY CAN GET STARTED. SO THESE WILL -- THAT'S WHY WE ARE BRINGING IT TO YOU NOW WITHOUT PERHAPS THE AMOUNT OF CHARACTERIZATIONS SEEN FROM SOME THINGS YOU SAW. WE ARE GIVING YOU THE BROAD PARAMETERS AND ASKING PERMISSION TO USE BEST JUDGMENT FOR THE FINAL PRODUCT. >> WOULD THIS BE SAME SCOPE FOUR, FIVE, SIX PROJECTS, AND WOULD THE OVERSIGHT BE SIMILAR WITHIN ADVISORY COMMITTEE THAT WOULD MEET IN A SHORT TIME SCALE, OR WOULD THIS BE LESS OVER SITE THAN WITH OTHER FOAs THAT HAVE GONE OUT? >> THIS WOULD LIKELY BE LESS OVERSIGHT AND MORE PROJECTS THAN SIX, WE HOPE, AGAIN INCREASE THE BASE SO THAT IF IN THE FUTURE WE DO ANOTHER SIMILAR RELEASE TO WHAT WE HAVE JUST DONE THEN WE HAVE GOT MORE SEED CORN SO TO SPEAK. TO COME IN AND REALLY INCREASE REGENERATIVE MEDICINE GROUPS AND APPROACHES CROSS FERTILIZATION. >> TOM, THIS WOULD BE AN OPPORTUNITY ESPECIALLY FOR INDIVIDUALS WHO HAVEN'T NECESSARILY WORKED TOGETHER TO DEVELOP THEIR COMRADERY AND TEAM EFFORT AS THEY MOVE FORWARD? >> THAT'S RIGHT. ALSO INFRASTRUCTURE SOFA SILTS, FOR CARE AND FOR DEVELOPMENT OF ANIMAL MODELS, THAT'S A BIG UNDERTAKING IN ITSELF. THAT WAS THE FIRST PART OF THIS LAST FOA SO WE THOUGHT -- WE HEARD FROM REVIEWERS THAT REVIEWED THESE PROJECTS. I ANNOUNCED AT THE REVIEW, I SAID YOU GOT -- THEY WERE CONCERNED ABOUT PRELIMINARY DATA AND FEEDSIBILITY, THAT'S REALLY IMPORTANT. A LOT OF JOBS WERE INCREDIBLY COMPETITIVE BUT YOU DON'T WANT TO WAVE A MAGIC WAND AND CURE A DISEASE. THERE'S SOME SCIENCE THAT NEEDS TO BE DEVELOPED. SO WE THOUGHT STARTING AT THAT FIRST BASIC SCIENCE FIRST STEP, REALLY QUICK HIT THE GROUND RUNNING GET THESE PEOPLE TO DEVELOP MORE FULL REGENERATIVE MEDICINE. WILL BE WISE TO DO. >> WOULD THE DOLLAR VALUE BE SIMILAR TO THE R-21? >> YES, IT WOULD BE PROBABLY ON THAT SCALE. >> MAY I HAVE A MOTION TO APPROVE THIS CONCEPT IN >> SO MOVED. >> AYES? >> AYE. >> AYE. >> THANK YOU. WE HAVE DR. RAY AND PASCALLI PARTICIPATING BY PHONE, SHOULD HAVE ANNOUNCED THAT EARLIER. THANK YOU VERY MUCH. >> LET ME ASK TOM A QUESTION. SO YOU PUT THE NEWS ON THE STREET AND GIVE HOW MUCH TIME FOR APPLYING FOR THE NOMINALLY R-21, THEN THAT WOULD RUN FOR TWO YEARS. FOA WOULD FOLLOW THAT AT THE RIGHT INTERVAL? >> YES POTENTIALLY. WE'RE TRYING TO DO THINGS ONE STEP AT A TIME AND METHODICALLY AS YOU KNOW. PROVIDE THREE FOUR MONTHS FOR PEOPLE TO COME IN AND GET THINGS GOING NEXT AND THEN PEOPLE WILL BE POISED AFTER THAT ONE TO TWO YEAR TIME PERIOD TO BE COMPETITIVE FOR FUTURE PROJECTS. I SAW HEAD NODSES THANK YOU FOR THE AYES. MY TIME OFF THE HOT SEAT ALMOST DONE. >> I WOULD LIKE TO ACTUALLY ASK STEVE BECKER ABOUT NEXT EGI WORKSHOPS, THE ONE SFM IN 2019. I JUST HEARD BOTON ROSCA SPEAK ABOUT HIS ASTOUNDING ADVANCES IN DOING RETINA IN A DISH, IT'S RETINA IN A ATTACHED TO BRAIN ORGANOIDS. SO I'M WONDERING THIS WAS TRUE OF AGI WORKSHOP, I CO-CHAIRED. WE DIDN'T HAVE ANY FOLKS OUTSIDE OF THE U.S. OBVIOUSLY NOT SUPPORTED BY NEI. I'M WONDERING IF IT'S BENEFICIAL TO BRING IN FOLKS SUCH AS BOTON TO THE TABLE FOR THAT GATHERING. >> ABSOLUTELY. >> THANKS FOR THE SUGGESTION. I THINK THERE'S ADVANCES GOING ALL AROUND THE WORLD. ESPECIALLY SFN WHERE AR THERE WOULD BE A GOOD IDEA TO CAPITALIZE ON THAT. THANKS FOR THE SUGGESTION. IT'S A GOOD ONE. >> I ALSO NOTE AT THE LAST MEETING YOU HAD THERE WAS A SUBSTANTIAL NUMBER OF PEOPLE FROM OVERSEES AND A LOT OF PEOPLE INVITED WHO MAKE IT SO THERE WAS -- IT'S BEEN AN AREA -- >> I WAS ALSO GOING TO ADD THAT FOR THE FOA IT WAS ASTOUNDING WHAT GROUPS CAME IN, NOT JUST ACADEMIA, WE FUND AD LOT OF ACADEMIA PROJECTS BUT WE HAD FOREIGN PROJECTS COME IN, A LOT WERE EXCITING. THERE'S ALSO INDUSTRY COMPOSITION AS WELL. ACADEMIA OVERSEINGS AND HERE ON U.S. SOIL AS WELL AS INDUSTRY SMALL COMPANIES THAT DEVELOP PRE-CLINICAL IDEAS MORE THAT WE SEE THAT IN THE FUTURE ARE ABLE TO SUPPORT THAT. >> ONE OTHER COMMENT, THIS IS MORE GENERIC TO THE FOAs IN THESE PROJECTS AS THEY GO FORWARD. I WAS FORTUNATE TO BE INVOLVED WITH THE LAST GENERATION OF THIS MODEL WHICH WAS THE NANOTECHNOLOGY DISCOVERY CENTER NDCPN 2 MECHANISM. THEY HAD AN INTERESTING OVERSIGHT MECHANISM WHICH INCLUDED ANNUAL JAMBOREE OF ALL NDCC SITES THAT WERE FUNDED WHICH INCLUDED INVITE STUDENTS AND POST-DOCS AND IT WAS A MEETING WHERE ALL GROUPS GOT TO HEAR WHAT WAS GOING ON. AND A VERY INTENSIVE INDIVIDUAL GROUP OVERSIGHT. WHICH RICHARD FISHER LED FOR NEI. THAT WAS A REAL IN THE WEEDS VERY INTENSE DISCUSSION OF MILESTONES, BARRIERS, ITSELF AT THE TIME AS INVESTIGATOR -- THAT AT THE TIME WAS MODERATELY PAINFUL AND ESSENTIAL TOLL ADVANCES WE DID MAKE WHICH WAS TO GET TO THE PRE-IND STAGE WITH THAT PARTICULAR PROJECT. PI THINK IT IS A VERY SUCCESSFUL MODEL AND I SUGGEST CONSIDERATION COPYING FROM THAT MODEL IN TERMS OF PROVIDING OVERSIGHT NOT JUST THE WHOLE GROUP WITH ADVISORY PANEL BUT EACH INDIVIDUAL GROUP AS THEY MOVE FORWARD. >> >> I WILL TAKE SOME CREDIT FOR NEI SINCE WE DEVELOPED THAT MODEL. >> GREAT COMMENT. WE H THINK ABOUT THAT GOING FORWARD. MAYBE AT SOME POINT WE CAN HAVE LARGE AUDACIOUS GOALS FOR REGENERATIVE MEDICINE MEETING WITH ALL PAST PIs COMING TOGETHER MIGHT BE AN IDEA FOR FUTURE. TAKE TO HEART. >> FROM ANYTHING ELSE? >> TOM, THANK YOU VERY MUCH. THAT CONCLUDES THE FIRST HALF OF THE OPEN SESSION. NOW WE'LL TAKE A 15-MINUTE BREAK. >> GOOD MORNING, EVERYONE. I AM SANGEETA BHARGAVA, PROGRAM OFFICIAL IN THE COLLABORATED CLINICAL RESEARCH PROGRAM. WITHIN THE DIVISION OF EXTRAMURAL SCIENCE. WHAT I'M GOING TO DO TODAY IS GIVE YOU A BRIEF OVERVIEW OF THE NEI CLINICAL RESEARCH. I AM THE SOLE REPRESENTATIVE TODAY OF MY PROGRAM HERE, MY OTHER TWO DISTINGUISHED ESTEEMED COLLEAGUES DON EVERETT AND MARY REDFORD HAVE CONFLICTS AND ARE ATTENDING DSMC MEETINGS. THEY ARE AN INTEGRAL PART OF OUR JOB AND WE DO IT ON A REGULAR BASIS. AS AN NEI REPRESENTATIVE TO GIVE THE RIGHT AMOUNT OF OVERSIGHT. SO IN THE PAST FEW COUNSEL ROUNDS YOU HAVE HEARD A LOT OF BASIC PROGRAMS CONCERNING THE RETINA, THE CORNEA, THE LENS AND THE GLAUCOMA AND LOW VISION. WHAT I WANT TO EMPHASIZE IN THIS EXTRAMURAL MATRIX, THE COLLABORATORS CLINICAL RESEARCH PROGRAM CROSSES OVER ALL OF THEM. THAT MEANS WE HAVE CLINICAL STUDIES AS WELL AS TRIALS FROM ALL THESE AREAS WHICH IS THE RETINA, CORNEA, LENS GLAUCOMA AND LOW VISION. OUR MAIN GOALS OF OUR CLINICAL RESEARCH PROGRAM IS TO TEST NEW AGENTS TECHNOLOGIES AND OTHER INTERVENTION FOR THE PREVENTION DIAGNOSIS TREATMENT OF DISEASES AND ARE IMPROVED VISION RELATED QUALITY OF LIFE. WE FUND APPLICATIONS THAT CONDUCT POPULATION BASED RESEARCH TO DESCRIBE THE PREVALENCE OF EYE DISEASE ACROSS THE LIFE SPAN AND WITHIN AMONG DIVERGENT DEMOGRAPHIC GROUPS, WE HAVE APPLICATIONS THAT CONDUCT STUDIES TO IDENTIFY RISK FACTORS FOR BOTH DEVELOPMENT, PERSISTENCE AND PROGRESSION OF EYE DISEASE AND APPLICATIONS THAT DO SECONDARY DATA ANALYSIS USING EXISTING DATABASE RESOURCES. WE ALSO HAVE A LOT OF GRANTS IN OUR PORTFOLIO WHICH LOOK AT THE -- TO CONDUCT SYSTEM LEVEL HEALTH SERVICE RESEARCH TO INCLUDE VISION HEALTH AND REDUCED HEALTH DISPARITIES. AND WE ALSO HAVE APPLICATIONS THAT ARE LOOKING TO DEVELOP NEW STATISTICAL METHODOLOGY OR TOOLS APPROPRIATE FOR ANALYZING VISION HEALTH DATA AND LASTLY APPLICATIONS THAT DEVELOP NEW APPROACHES TO CONDUCTING CLINICAL RESEARCH STUDIES INCLUDING THAT CAPITALIZE PIPE OF CARE AS WELL AS ELECTRONIC MEDICAL RECORDS. THE WAY WE DO OUR CLINICAL TRIALS IS TWO MECHANISMS. ONE IS CORPORATE AGREEMENT AND EARLIER IN THE MORNING YOU HAVE HEARD OF UO 1 AND U 24s. THE ACTIVITY CODE WE USE IN THE CLINICAL TRIALS IS THE UG 1. THESE ARE FOR BIGGER TRIALS. AND I JUST WANT TO REMIND THE COUNCIL MEMBERS THAT THE COOPERATIVE AGREEMENT IS A SUPPORT MECHANISM THAT NIH FREQUENTLY USES FOR HIGH PRIORITY RESEARCH AREAS THAT REQUIRE A LOT OF INVOLVEMENT FROM NIH STAFF WHICH IS MUCH MORE THAN WHAT A TYPICAL RESEARCH PROJECT ON R GRANT COULD BE. WE ALSO DO CLINICAL STUDIES AN EPIDEMIOLOGY STUDY IT IS USING THE R MECHANISMS AND THESE ARE FOR SIMPLER CLINICAL AND EPI STUDIES USING THE RO1. WE HAVE SECONDARY DATA ANALYSIS WHICH WE USE R-21 AND THIS IS ONE MORE POPULAR PROGRAM IN OUR PORTFOLIO. WE ALSO DO A LOT OF CLINICAL STUDY PLANNING GRANTS AND THOSE ARE THE R-34 GRANTS. SO IN THE NEXT COUPLE OF SLIDES WHAT I'M GOING TO SHOW YOU IS A FEW EXAMPLES OF OUR CLINICAL TRIALS AND EPI STUDIES THAT WE HAVE DONE OVER TIME BUT I ALSO WANT TO REMIND THE COUNSEL MEMBERS THAT BEFORE WE DO ANY STUDY OR WE START ANY CLINICAL TRIAL OR EPI WE ALWAYS BRING YOU TO THE COUNCIL FOR THE DISCUSSION, FOR THE INPUT BEFORE ANY TRIAL IS STARTED. SOME OUR EPI STUDIES, THESE ARE JUST EXAMPLES TO GIVE YOU A FLAVOR OF THE KIND OF STUDIES WE HAVE OVER TIME, WE HAVE DONE A GLAUCOMA EVALUATION STUDIES FOR AFRICAN DESCENT, WE HAVE DONE DEMOGRAPHIC POPULATION, WE HAVE DONE CHEST STUDY, THE CHINESE HEALTH EYE STUDY, WE HAVE DONE THE LATINO EYE STUDY WE HAVE LOOKED AT INFECTIOUS DISEASE WE HAVE DONE FOR THE AIDS COMPLICATION, SOFA STUDY WE HAVE DONE UVEITIS WE HAVE DONE UVEITIS FOLLOW-UP STUDY. WE ALSO LOOKED IN TO STUDIES EPI STUDIES IN CHILDREN AND THAT HAS BEEN THE -- STUDY AACDAT STUDY SO WE HAVE DONE QUITE A FEW STUDIES, JUST TO GIVE YOU A FLAVOR OF SOME OF THE E PI STUDIES WE HAVE DONE. BESIDES EPI STUDIES WEK LOUED IN CLINICAL TRIALS, THESE ARE. EXAMPLEPS OF CLINICAL TRIALS, WE LOOKED INTO CLINICAL TRIALS USING INTERVENTIONS, SOME THAT TARGET DISEASES, CAT STUDY, WHICH IS TOKING AT THE AND, WE HAVE THE SCORE TWO WHICH IS TO DO RETINAL OCCLUSION, WE HAVE SOME INFECTIOUS DISEASES LIKE -- WE HAVE DISEASE TRIALS IN THE UVEITIS FIELD, -- IS ONE OF THEM. WE HAVE STUDIES THAT WE HAVE DONE FOR EARLY TREATMENT OF ROP. WE HAVE STUDIES DONE FOR UVEITIS, ONE IS THE FAST. AND WHAT I REALLY WANT TO BRING OUT IS THAT AS THE RESEARCH IN BASIC RESEARCH IS MOVING ALONG, AS ADVANCES IN BASIC RESEARCH COME ALONG, WE ALSO HAVE MORE CLINICAL TRIALS IN THAT AREA. SO FOR EXAMPLE, WE JUST RECENTLY FUNDED SOME CLINICAL TRIALS USING STEM CELL THERAPY AS WELL AS GENE THERAPY. AND THOSE ARE EXAMPLES THE TRUST AND -- STUDY. EARLIER IN THE MORNING, DR. SIEVING ALLUDED TO THE NETWORKS AND THESE ARE ONE OF OUR SUCCESS STORIES IN OUR PORTFOLIO. OF THE CRR NETWORKS. WE HAVE TWO NETWORKS. SO WE HAVE BEEN INVOLVED IN THE PAST FEW YEARS. ONE OF THEM IS THE PEDIATRIC EYE DISEASE INVESTOR GROUP AND THE OTHER ONE IS THE DIABETIC RETINOPATHY CLINICAL RESEARCH NETWORK GROUP. ONE THING DR. SIEVING ALSO ALLUDE IN THE MORNING SESSION IS DIFFERENCE BETWEEN NETWORK AS WELL AS CLINICAL TRIALS THAT EPI STUDIES THAT I SHOWED YOU BEFORE. THE TRIAL IS BASICALLY ONE PROTOCOL BUT WITH THE NETWORKS BECAUSE THEY HAVE SO MANY CLINICAL SITES INVOLVED SO MANY PHYSICIANS INVOLVED, THEY ARE DOING MULTIPLE PROTOCOLS AT ONE TIME. COUPLE OF THINGS TO POINT OUT ABOUT OUR NETWORKS IS ONE THAT WHICH IS VERY UNIQUE ACROSS THE NIH, IS ONE THAT THEY ARE OPEN NETWORK. THAT MEANS PRETTY MUCH ANYONE CAN JOIN INTO DO A PROTOCOL, THEY CAN DO TWO PROTOCOLS IF THEY WANT TO DO OR IF THEY DON'T WANT TO DO A PROTOCOL THEY DON'T NEED TO DO IT. AS DR. SIEVING EARLIER ALSO POINTED OUT, MOST OF THE THE PHYSICIANS ARE COMMUNITY BASED PROVIDERS AND ONE IS FOR ACADEMIC INSTITUTION. BOTH THE NETWORKS HAVE BEEN AN EXAMPLE OF PRIVATE PUBLIC PARTNERSHIPS AND LAST BUT NOT THE LEAST I WANT TO POINT OUT THEY HAVE BEEN VERY COLLABORATIVE AND IN TERMS OF THE OTHER NIH INSTITUTES. WE DO COLLABORATE WITH THE NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DISEASES AND NICHD, ORTHOPEDIC AND FOR DRCRN THERE IS GOING COLLABORATION WITH NIDDK AS WELL AS CO-FUNDING BY THE SAME INSTITUTE. BEFORE I TAKE YOU TO THE MAIN SCIENTIFIC PRESENTATION, WE HAVE THIS OPPORTUNITY HERE IF THE DIABETIC GROUP, CURRENT LEADERSHIP IS HERE TODAY TO TALK ABOUT THEIR DRCRN NETWORK, BEFORE THEY GO TO THAT EXCITING PRESENTATION, I JUST LIKE TO TELL YOU WHO THESE PEOPLE ARE. ADAM GLASSMAN IS DIRECTOR OF THE -- CENTER AT J HE STARTED WITH DRCRN IN 2003 AS A BIOSTATISTICIAN. IN 2006 HE BECAME THE ASSISTANT DIRECTOR FOR DRCRN NET UNDER DIRECTION OF DR. ROY BECK. IN 2009 TO PRESENT HE'S DIRECTOR FOR DRCR NET COORDINATING CENTER. ADAM HAS SERVED AS PRINCIPLE INVESTIGATOR FOR THE COORDINATING CENTER ON OVER 20 NIH FUNDED STUDIES AS WELL AS THREE JDRS FUNDED STUDIES. HE HAS CO-AUTHOR OVER 80 PEER REVIEWED PUBLICATIONS. HE'S ALSO ON THE ADVISORY BOARD OF THE COCHRAN EYE AND VISION GROUP THAT IS NEI FUNDED STUDY. EDITORIAL BOARD FOR JAMA OPHTHALMOLOGY AND -- ADAM IS MAIN PI ON DRCRN NETWORK APPLICATION. IF I MAY SAY SO, HE IS THE WALKING INENCYCLOPEDIA FOR THE NETWORK. WE HAVE TWO CO-CHAIRS, TWO CHAIRS, IN THE NETWORK DR. JENNIFER SUN IS IN CHARGE OF DIABETIC INITIATIVE DRCRN NETWORK AND IS FIRST WOMAN CHAIR FOR THE NETWORK. SHE'S PRESENTLY AN ASSOCIATE PROFESSOR AT THE HARVARD DEPARTMENT OF OPHTHALMOLOGY AND GRADUATED FROM HARVARD COLLEGE AND HARVARD MEDICAL SCHOOL AND COMPLETED OPHTHALMOLOGY RESIDENCY AND RETINAL SURGICAL FELLOWSHIP AT THE MASS EYE AND -- INFIRMARY. FROM 2005 TO 2009 SHE WAS FIRST PROGRAM IN THE HARVARD VISION CLINICAL SCIENTIST KEY PROGRAM AND RECEIVED A LAST YEAR'S PUBLIC HEALTH IN 2007 AT THE HARVARD SCHOOL OF PUBLIC HEALTH. SHE SERVED AS THE NETWORK'S NATIONWIDE PROTOCOL INVESTIGATOR FROM 2010 TO 2017 AS WELL AS THE NETWORK VICE CHAIR FROM 2012 TO 2014. SHE HAS BEEN THE NATIONWIDE CLINICAL CHAIR FOR THEE DRCRN NET STUDIES, WHICH IS EVALUATION OF VISUAL ACUITY MEASUREMENTS IN EYES AND MACULAR EDEMA. PROTOCOL AA WHICH IS THE PERIPHERAL DIABETIC RETINOPATHY ON ULTRA WIDE FUNDUS IMAGES AND WORSENING OVER TIME, PROTOCOL -- PREVENTION OF VISION THREATENING COMPLICATIONS IN EYES AND HIGH RISK TO ANTI-VEGF TREATMENT. SHE'S ALSO SEARCHED AS THE NATIONWIDE PI FOR BOTH THE MULTI-CENTER DME FUND STUDIES DIABETIC MACULAR EDEMA FUND BY UCT UTILIZATION ON NON-OPTHALMIC DIABETES CARE VISITS. DR. SUN LEADS STUDIES IDENTIFYING BIOMARKERS OF FUNCTIONAL AND ANATOMIC OUTCOMES IN DIABETIC RETINOPATHY AND DIABETIC MACULAR EDEMA TO ADVANCES IN TECHNIQUES SUCH AS ADAPTIVE OPTICS SCANNING LASER AND OCTA. SHE'S CME EDITOR OF JAMA OPHTHALMOLOGY AND CURRENT RECENT PUBLICATIONS INCLUDE ARTICLES IN NEW ENGLAND JURY ROOM OF MEDICINE AS WE AS IN JAMA. SHE RECEIVED MULTIPLE AWARDS. MOST NOTABLY ARE THE 2008 EARLY CAREER CLINICIAN SCIENTIST RESEARCH AWARD, THE 2016 RPP PHYSICIAN SCIENTIST AWARD AND THE 2018 JDRF MARY TYLER MOORE AND ROBERT LEVINE EXCELLENCE IN CLINICAL RESEARCH AWARD AND DELIVERED MORE RESUBPOENALY IN 2017, THE -- RECENTLY IN 2017 THE WILL MANIER EYE INSTITUTE JOSEPH SMI THE -- SMITTY CHAIR. THE OTHER NETWORK IS DR. DAN MARTIN WHO HEADS THE NON-DIABETIC INITIATIVE PARTS OF THE NETWORK. HE'S ALSO THE CHAIR OF THE CLEVELAND CLINIC EYE INSTITUTE, THE BARBARA AND MALACCI NIXON INSTITUTE CHAIR IN OPHTHALMOLOGY AND PROFESSOR OF OPHTHALMOLOGY IN THE CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE AT CASE WESTERN UNIVERSITY. DR. MARTIN COMPLETED HIS MEDICAL SCHOOL FROM THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE FOLLOWED BY RESIDENCY AND CHIEF RESIDENCY IN OOP THAT WILLMOLOGY AT EMORY UNIVERSITY SCHOOL OF MEDICINE. HE COMPLETED A FELLOWSHIP IN SURGERY AND DISEASES FROM DUKE EYE CENTER FOLLOWED BY TWO YEAR FELLOWSHIP IN UVEITIS AND OCULAR FOR THE NATIONAL EYE INSTITUTE. DR. MARTIN WOULD HAVE BEEN STUDY CHAIR FOR THE CAT STUDY AND HE IS ALSO A STUDY CHAIR FOR SIX OTHER NATIONAL CLINICAL TRIALS INCLUDING THOSE THAT LECTURE THE FDA APPROVAL OF CYCLOVEER. HE HAS SERVED AS PI MEMBER OF DSMC AND MEMBER OF STEERING COMMITTEES FOR DOZENS OF OTHER STUDIES INCLUDING -- DR. MARTIN HAS PUBLISHED MORE THAN 200 PEER REVIEW ARTICLES DELIVERED 35 LECTURES AND MORE THAN 340 INVITED LECTURES. HE'S ALSO RECIPIENT OF NUMEROUS AWARDS INCLUDING THE -- GAS METAL ROGER JOHNSON AWARD IN AMT, THE ROSETHAL AWARD, THE SANGEETA MARIA MILLER AWARD FOR SCIENTIFIC RESEARCH AND CLASS METAL. THE ONE THING COMMON FOR ALL THESE THREE PEOPLE THAT ARE EXCELLENT SPEAKERS SO WITHOUT -- WITH THAT I WOULD LIKE TO WELCOME THEM TO GET THEIR SCIENTIFIC PRESENTATION ON DRCRN NET PAST, PRESENT AND FUTURE. THANK YOU. >> EXCELLENT, THANK YOU VERY MUCH. THANK YOU FOR GIVING US THE OPPORTUNITY TO PRESENT THE ACCOMPLISHMENTS OF DRCR NETWORK OVER THE PAST DECADE AND A HALF AND TO SHARE WITH YOU SOME VISION OF THE FUTURE. SO OUR PLAN FOR TODAY IS TO GIVE A LITTLE BRIEF OVERVIEW INTO THE HISTORY OF THE DRCR NETWORK. WE'LL SHARE SOME OF THE NETWORKS MAJOR IMPACT ON DIABETIC RESEARCH AND CLINICAL CARE. WE'LL TALK HOW THE NETWORK IS ABLE TO MAINTAIN PRODUCTIVITY OVER 16 YEARS T TALK A LITTLE BIT ABOUT THE OUR VISION FOR THE FUTURE OF RESEARCH IN DIABETIC RETINOPATHY, AGE RELATED MACULAR DEGENERATION AND OTHER DISEASES AND HAVE OPPORTUNITY FOR DISCUSSION FROM THE COUNCIL. WHO ARE WE? DRCR NETWORK IS AN OPEN COLLABORATIVE GROUP WITH DIVERSE CLINICAL SITES FROM ACROSS NORTH AMERICA, MOSTLY IN THE UNITED STATES, WE DO HAVE SOME SITES IN CANADA AS WELL. WE ARE DEDICATED TO RIGOROUS IMPACTFUL CLINICAL RESEARCH OF RETINAL DISEASE. THE WAY WE WILL ACCOMPLISH THIS IS PERFORM HIGH QUALITY CLINICAL STUDIES THAT LEAD TO BETTER UNDERSTANDING OF RETINAL DISEASE, ADVANCE TREATMENT AND IMPROVE LIVES OF INDIVIDUALS WITH RETINAL PATHOLOGY. IN 2002 THE NEI DISTRIBUTED RFA TO CREATE A STANDING INFRASTRUCTURE THAT ALLOWS FOR RAPID DEVELOPMENT AND IMPLEMENTATION IN CLINICAL TRIALS IN DIABETIC RETINOPATHY. AS A RESULT OF THAT RFA IN 2002 THE DRCR NET WAS BORN. OVER THE DECADE AND A HALF TO FOLLOW THE NETWORK HAS EVOLVED INTO EFFICIENT MATURE NETWORK CONDUCTED 30 MULTI-CENTER STUDIES IN DIABETIC RETINOPATHY, WE HAVE 100 PUBLICATIONS TO DATE AND CURRENTLY WE HAVE A LITTLE OVER 150 ACTIVE CLINICAL SITES AND OVER 300 SITES THAT HAVE PARTICIPATED IN THE NETWORK SOME TIME OR ANOTHER. LAST YEAR WE ADDED A FOCUS OF ALL RETINAL DISEASE TO TURMOIL IN ADDITION TO SPANNING -- TO OUR PORTFOLIO, IN ADDITION TO DIABETIC RETINOPATHY OVER 15 YEARS SO WE WILL TALK VISION FOR EXPANSION IN TWO OTHER RETINAL DISEASE AS A PRESENTATION MOVES ALONG. SO THERE ARE FOUR MAIN UNITS THAT MAKE UP THE DRCR NETWORK. WE HAVE A WONDERFUL PRESENTATION FROM NEI ROLE AS SCIENTIFIC LEADS DR. SUN AND DR. MARTIN MY TEAM AT THE COORDINATING CENTER OF CURSE OUR CLINICAL SITES WHICH SPAN OVER 500 INVESTIGATORS AND RIGHT NOW IN THE NETWORK ALL TOLD ABOUT 1800 MEMBERS INCLUDING INVESTIGATORS AND COORDINATORS TECHNICIANS, AND OTHER SUPPORT STAFF. NONE OF THIS IS POSSIBLE WITHOUT PRIOR LEADERSHIP FROM DR. -- AS PRIOR CHAIRS, ALSO MY MENTOR AT THE COORDINATING CENTER, DR. BECK. WITH THAT I'M GOING TO TURN IT OVER TO DR. SUN WHO WILL START DISCUSSION BY TALKING ABOUT THE IMPACT THE NETWORK MADE ON CLINICAL CARE AND DIABETIC RETINOPATHY. >> THANK YOU, ADAM. THANK YOU AGAIN FOR THE PRIVILEGE OF SPEAKING TO THE COUNCIL TODAY. I'LL JUST SET THE STAGE BY SAYING WE ACKNOWLEDGE TWO MAJOR CAUSES OF VISUAL LOSS FROM DIABETES FACED WITH WHEN WE BEGAN OUR WORK. DIABETIC MACULAR EDEMA OR THICKENING FROM ABNORMAL LEAKAGE WHICH IS THE MOST COMMON CAUSE OF MODERATE VISION LOSS IN DEE BITE PATIENTS IN DEVELOPED COUNTRIES LIKE U.S. THESE DAYS. IN AUDITION,, PROLIFERATIVE DIABETIC RETINOPATHY OR DEVELOPMENT OF NEOVASCULARRIZATION, YOU CAN SEE HERE LEAD TO THINGS LIKE BLEEDING, TRACTION RETINAL DETACHMENT, PUTTING PATIENTS AT HIGH RISK FOR SEVERE VISION LOSS. TO PUT THIS IN CONTEXT BEFORE 2003 WHEN THE NETWORK INITIATED ITS STUDIES, LASER PHOTO COAGULATION WAS NOT PRIMARY BUT THE ONLY METHOD WE HAD TO TREAT ALL DIABETIC EYE DISEASE. THAT IN PART WAS THE IMPETUS TO FORM A NETWORK THAT COULD DO MULTIPLE STUDIES TO ADVANCE THE FIELDS. SINCE 2003 AS ADAM SAID DRCR NETWORK INITIATED 30 STUDIES THAT HAVE TRANSFORMED THE STANDARD OF CARE FOR DIABETIC EYE DISEASE IN THE U.S. AND THROUGHOUT THE WORLD. WE ADDRESSED EFFICACY OF ANTI-VEGF THERAPY FOR NEW STANDARDS OF CARE PROVIDED ALGORITHMS TO GUIDE CLINICIAN TREATMENT WITH ANTI-VEGF FOR THESE COMPLICATIONS OF DIABETES. WE EVALUATED OUTCOMES OF STEROID THERAPY, HI WILL TALK ABOUT THAT IN A MOMENT. WE STARTED TO ELUCIDATE EFFECTS OF ANTI-VEGF AND STEROID ON IMPROVING DIABETIC RETINOPATHY. THIS IS NOT SOMETHING WE HAD EVERY SEEN BEFORE, IN THE NATURAL HISTORY DISEASE OR PREVIOUS TREATMENTS. WE ADDRESSED COST EFFECTIVENESS OF TREATMENTS FOR DNR AND DME AND LOOK AT EVALUATION OF EYES IMENING MAAING AND ACUITY MEASUREMENTS. SO THIS IS IS THE DRCR PROTOCOLS AND A PICTURE OF NINE STUDIES CURRENTLY ENROLLING OR IN FOLLOW-UPS SO WE HAVE A VERY ACTIVE PORTFOLIO. I WILL TALK IN THE NEXT FEW MINUTES ABOUT SOME OF THE OUR STUDY HIGHLIGHTS, MAJOR ADVANCES WE THINK THE NETWORK CONTRIBUTED OVER THE COURSE OF THE PAST 15 YEARS AND YOU WILL SEE ALSO HEAR QUOTE FROM NEI PRESS RELEASES, DR. SIEVING WILL SEE HIS NAME HERE A LOT LOT BECAUSE WE THOUGHT ELEGANTLY SUMMARIZED THE IMPACT OF STUDIES. OUR PROTOCOL B WAS OUR FIRST MAJOR INTERVENTIONAL STUDY REPORTED IN 2008 INDIVIDUAL STEROIDS FOR DME AND THE BACK GROUND TO THIS WAS THAT IN THE EARLY 2000s POTENTIAL BENEFITS OF STEROID WITHIN THE EYE WERE REPORTED TO TREAT D MECHANICSE AND CLINICS WERE VERY IMPRESSED RAPID RETINAL THINNING AND IMPROVEMENTS IN ACUITY IN EARLY SMALL CASE SERIES THAT WERE REPORTED TO THE POINT BY THE NEXT YEAR OVER 50% RETINA SPECIALISTS REPORTED USING DESPITE WE HAD LIMITED DATA SUPPORTING LONG TERM VISION BENEFIT. NETWORK DID COMPARATIVE EFFECTIVENESS STUDY LOOKING AT LASER TREATMENT WHICH IS THE STANDARD OF CARE COMPARED TOED TWO DOSES OF -- IN THE EYE AND WE FOUND VERY INTERESTINGLY THAT ALTHOUGH IN THE SHORT TERM STEROID IMPROVED VISION BY ONE YEAR THE VISUAL ACUITY RESULTS WERE NO BETTER THAN LASER AND BY TWO YEAR THE LASER TREATEDDED EYES WERE DOING BETTER IN VISION. THERE WAS A DRAMATIC SUBSEQUENT DECREASE IN USE ENTERINDIVIDUAL FOR DME AND WE THINK IT HAD SIGNIFICANT IMPACT ON QUALITY OF LIFE AND WAY CARE APPROACHED FOR PATIENTS ACROSS THE U.S. AND GLOBALLY. OUR NEXT MAJOR INTERVENTIONAL PROTOCOL I IN 2010 THEN LOOKED AT STEROIDS BUT ALSO AT ANTI-VEGF THIS WAS THE FIRST PHASE 3 TRIAL REPORTED OUT DEMONSTRATING THAT ANTI-VEGF IS EFFICACIOUS FOR TREATMENT OF DME. WE KNEW AT THAT POINT THAT ANTI-VEGF WAS USEFUL FOR NEUROVASCULAR AMD BUT AFFECT IN DME WAS NOT FULLY KNOWN, AT THE TIME AGAIN MACULAR LASER WAS EFFICACIOUS BUT NOT COMPLETELY SO FOR ALL EYES WITH DME. IT WAS A CLEAR UNMET NEED FOR NOVEL THERAPY. THE RESULTS WERE DRAMATIC. IN THE FIRST YEAR THERAPY PRIMARY OUTCOME TIME POINT A DRAMATIC IMPROVEMENT IN OUTCOMES IN TREATED EYES IN BLUE AND ORANGE COMPARED TO THE LASER TREATED EYES IN PURPLE. THIS REALLY SET A NEW STANDARD OF CARE FOR PATIENTS WITH DIABETIC MACULAR EDEMA WHO EXPERIENCE VISION LOSS AN SHOW FIRST TIME WE WERE HAVING DRAMATIC IMPROVEMENTS IN VISION WITH THESE EYES IN DME. OUR PROTOCOL T DR. SIEVING REFERRED TO THIS IN HIS INTRODUCTORY REMARKS AND THIS WAS OUR COMPARATIVE EFFECTIVENESS TRIAL, THIS POINT IN TIME AS WE SET TO DESIGN STUDY WE KNEW THERE WAS A CLEAR MANDATE FOR ANTI-VEGF AS FIRST LINE THERAPY FOR DME. THE MAJOR DIFFERENCES IN COST AND AVAILABILITY BETWEEN ANTI-VEGF AGENTS SO THERE WAS A MAJOR PUBLIC HEALTH IMPORTANCE TO UNDERSTANDING THESE DIFFERENCES. THIS WAS A STUDY THAT NEVER WOULD HAVE BEEN DONE BY INDUSTRY ALONE. BECAUSE OF THE NETWORKS GOVERNMENT SPONSORSHIP WE WERE ABLE TO PULL TOGETHER SUPPORT FROM INDUSTRY PARTNERS TO PERFORM THE STUDY IN A WAY THAT I THINK GAVE IMPORTANT RESULTS FOR PATIENTS. WHAT WE FOUND IS ON ONE HAND WE WERE PLEASED TO SEE THAT ALL THREE AGENTSES WERE VERY EFFECTIVE IN IMPROVING VISION IN OUR PATIENTS WITH DME. ALTHOUGH ALL THREE HAD SIMILAR EFFECTS IN EYES THAT STARTED WITH JUST MILD VISUAL IMPAIRMENT, THERE WERE LARGE DIFFERENCES WHEN WE LOOK AT EYES WITH WORSE BASELINE VISION. 2050 OR WORSE. WE CLEARLY DEMONSTRATED THAT OF OUTPERFORMED THE -- OVER TWO YEARS, WITH ALMOST FOUR LINES OF VISION GAIN IN THE RECEPTOR TREATED EYES COMPARED TO TWO TO THREE ON AVERAGE IN THE BENEFIT SIDS HAS BEEN TREATED EYES. THIS HAS CHANGED THE WAY MANY OF US THINK ABOUT FIRST LINE THERAPY WHEN WE HAVE ACCESS TO FDA APPROVED TREATMENT FOR OUR PATIENTS. PROTOCOL S REPORTED PRIMARY OUTCOMES IN 2015 AT TWO YEARS AND FIVE YEAR RESULTS CAME OUT THIS SUMMER, SO WE WERE VERY EXCITED TO LOOK AT LONG TERM VISUAL ACUITY AND ANATOMIC OUTCOME WHEN WE TREATED EYES WITH ANTI-VEGF FOR NEW INDICATION PROLIFERATIVE DIABETIC RETINOPATHY. THOUGH OUR PREVIOUS STANDARD OF CARE COAGULATION LASER THIS I PI WAS EFFECTIVE AT NEOVASCULARRIZATION IT'S DESTRUCTIVE AND WE WERE WIPING OUT LARGE SECTIONS OF PERIPHERAL RETINA CAUSING CONSTRICTION OF PERIPHERAL VISION FIELDS AND CHANGES IN QUALITY OF LIFE FOR PATIENTS. WHAT WE FOUND OVER FIVE YEARS IS THAT ANTI-VEGF GIVES NON-INFERIOR VISUAL ACUITY OUTCOMES OVER TIME TO PRP SO IT'S A SAFE REASONABLE ALTERNATIVE TREATMENT. AND WE HAVE VALUABLE INFORMATION& FROM THIS TRIAL, NOT JUST LONG TERM VISUAL ACUITY RESULTS BUT PERIPHERAL VISUAL FIELD OUTCOMES TREATMENT BURDENED AND SAFETY OUTCOMES THAT MOVE TOWARDS LETTING OUR PATIENTS AN DOCTORS MAKE MORE INFORMED TREATMENT DECISIONS IS ABOUT HOW THEY'RE GOING TO APPROACH PROLIFERATIVE RETINOPATHY IN THEIR EYES. SO I THINK THE IMPORTANT QUESTION FOR US MOVING FORWARD IS WHAT ARE THE KEY ASPECTS OF THE NETWORK STRUCTURE AND APPROACH THAT ENABLED THIS BODY OF WORK AND I'M GOING TO HIGHLIGHT THREE CRITICAL COMPONENTS. NUMBER ONE, I WILL TALK ABOUT THE FACT WE SEE OURSELVES HAVING OPEN COLLABORATIVE TRANSPARENT PROCESS. NUMBER TWO WE RELY ON A RIGOROUS SCIENTIFIC REVIEW PROCESS FOR ALL OF OUR STUDIES BEFORE THEY EVER HIT PROTOCOL IMPLEMENTATION. DAN MARTIN WILL COME UP AND TALK ABOUT EFFICIENT COST EFFECTIVE AND WHAT WE THINK IS A PRODUCTIVE STUDY PIPELINE. SO LET'S TALK ABOUT OUR PROCESS. WE ARE AN OPEN NETWORK, WE WELCOME ANY QUALIFIED RETINA SPECIALIST IN U.S. AND CANADA AND EVERY YEAR WE HAVE FLUX OF NEW SITES, AS SHE ALSO MENTIONED ONE PRIORITY INITIATIVE UPON INITIATION WAS TO DEVELOP COMMUNITY AND ACADEMIC PARTNERSHIP AND THIS HAS BEEN REALLY SUCCESSFUL SO 68% CURRENT SITES ARE COMMUNITY SITES, WE HAVE THE STRENGTH OF EACH TYPE OF SITE IS LEVERAGED IN IN THIS PARTNERSHIP AND THE ABILITY TO WORK ACROSS THE NATION, ACROSS WIDE SITES ALLOWED A WHOLE NEW GENERATION OF RETINA SPECIALISTS TO EXPERIENCE PARTICIPATE IN QUALITY CLINICAL RESEARCH IN WAYS THAT HAVEN'T BEEN DONE BEFORE. THE DRCR URGES INVESTIGATORS AT EVERY STEP OF PROTOCOL DEVELOPMENT IMPLEMENTATION AND REPORTING, WE DO IT ACROSS INVESTIGATOR GROUP SO ALL OUR INVESTIGATORS HAVE THE OPPORTUNITY AND INDEED VERY MUCH ENCOURAGED TO COMMENT ON STUDIES IN DEVELOPMENT DOING IN PERSON READINGS WE HOLD TWICE YEARLY AS WELL AS EMAIL. WE SELECT INVESTIGATORS TO PARTICIPATE ON PROTOCOL DEVELOPMENT COMMUNITIES THAT ARE GOING TO DO THE HEAVY WORK PUTTING IN INITIAL PROTOCOL TOGETHER BASED ON PERFORMANCE NETWORK IN THE PAST. JUST RECRUITMENT LEVEL BECAUSE WE THINK THESE ARE THE INVESTIGATORS THAT REALLY HAVE THEIR FINGER ON THE PULSE OF WHAT IT MEANS TO PERFORM THIS WORK. WE SELECT INVESTIGATORS ON EXPERTISE. THIS ALLOWS THEM TO DO THREE THINGS. ONE IS TO PROVIDE SCIENTIFIC INPUT AND NUMBER TWO, TO DETERMINE FEASIBILITY OF STUDY PROCEDURES AND VISITS SO WE GET REAL WORLD FEEDBACK AND THREE WE WANT TO ENSURE OUR STUDY RESULTS WHETHER NEGATIVE OR POSITIVE ARE GOING TO IMPACT PRACTICE. WE MAKE A VERY CONCERTED EFFORT TO INVOLVE YOUNG INVESTIGATOR Z BECAUSE WE SEE IT AS A TREMENDOUS OPPORTUNITY FOR ALL OF US WHO PARTICIPATED OVER THE YEARS BUT BRINGING FORWARD NEW GENERATION OF RETINA PRACTITIONERS AND RESEARCH ENTHUSIASTS, OUR IMPLEMENTATION ROLES ONCE PROTOCOLS GET ROLLING, DEPEND ENTIRELY COORDINATING CENTER PLAYS A HUGE ROLE BUT INVESTIGATORS ARE THE FLESH AND BLOOD OF RECRUITMENT FOR PROTOCOLS TO GET THE PATIENTS IN, WE ENROLLED 10,000 PARTICIPANTS OVER NETWORK HISTORY. AND WE HAVE OVER 300 ACTIVE SITES. OUR INVESTIGATORS SERVE AS CHAIRS VICE CHAIRS ON OUR COMMITTEE TO MAKE OUR DECISION AND WHEN WE GO TOWARDS REPORTING RESULTS OUR INVESTIGATORS PLAY A CRITICAL ROLE. THEY'RE ALL GIVEN OPPORTUNITY TO COMMENT ON MANUSCRIPT DRAFT, NETWORK WIDE AND PLEASE SEND US COMMENTS BEFORE WE SUBMIT DRAFTS. INVESTIGATORS SELECTED TO PARTICIPATE ON WRITING COMMITTEES, AGAIN BASED ON LEVEL OF PARTICIPATION CRY ARE RECRUITMENT IN STUDY AND SCIENTIFIC CONTRIBUTIONS TO THE PROTOCOLS. TO DATE WE HAVE 142 INVESTIGATORS PATS U PATING ON COMMITTEES, 71 PRESENTED ON NATIONAL INTERNATIONAL MEETINGS. AND IT HAS BEEN A JOY AND PRIVILEGE TO WORK WITH INVESTIGATORS WHO HAVE NEVER DONE WRITE IN COMMUNITIES BEFORE NEVER PRESENTED AT MEETINGS, AND WORK THROUGH THAT PROCESS AND WHAT REMARKABLE RESULTS WE HAVE. WE ENDEAVOR TO BE TRANSPARENT IN PROCESSES AND AS PART OF THAT WE SEE OURSELVES AND OUR PUBLIC FACE AS COMMUNITY RESOURCE. ON OUR PUBLIC WEBSITE WE PUBLISH GET ACCESS TO NETWORK PUBLICATIONS WE LIST THEM AND LINK THEM WHERE WE MAKE THEM AVAILABLE, WE MAKE SLIDE SETS AVAILABLE FOR PUBLIC USE. WE WANT TO ENCOURAGE THOSE SLIDE SETS TO BE USED BY INVESTIGATORS IN THE COMMUNITY NOT JUST FOR OUR MAJOR PLATFORM PRESENTATIONS BUT LOCAL MEETINGS TEACHING RESIDENTS THROUGHOUT THE COMMUNITY, LAY PEOPLE ARE WELCOME TO DOWNLOAD THESE. WE REGULARLY UPDATE OUR PROTOCOLS POLICIES AND PROCEDURES AND THESE ARE AVAILABLE PUBLICLY. PARTICIPATING CLINICAL CENTERS AND WE HAVE RESOURCE FOR OTHER RESEARCH EFFORTS IN THIS AREA. AND I THINK A VERY IMPORTANT RESOURCE IS WE PROVIDE DEIDENTIFIED STUDY SETS ON THE WEBSITE AVAILABLE FOR DOWNLOAD, DEIDENTIFIED STUDY IMAGES AVAILABLE UPON REQUEST, THAT TAKES MORE COORDINATING EFFORT. OUR STUDY DATA TYPICALLY IS AVAILABLE TO PUBLIC ONE YEAR AFTER PUBLICATION AFTER STUDY RESULTS, WE HAVE 18 DATA SETS POSTED ON DRCR.NET AND 4,300 MORE DOWNLOADS OF THE STUDY SETS BY OTHER 2000 UNIQUE RESEARCHERS TO DATE WE HAVE SHARED NEARLY 42,000 IMAGES AMONG MULTIPLE DIVERSE ACADEMIC GROUPS INCLUDING YOUNG GIRL COMPUTING LEAGUE AND WE'RE LOOKING FORWARD TO HEARING RESULTS FROM THEM. I WILL ALSO EMPHASIZE RIGOROUS SCIENTIFIC REVIEW OF PROTOCOLS. WE THINK THE MULTI-LAYERED PROTOCOL APPROVAL PROCESS GIVES US HOPEFULLY HOPEFULLY ROBUST WELL DESIGNED CLINICALLY RELEVANT STUDIES SO I WILL WALK THROUGH OUR PROTOCOL PROCESS BECAUSE I WANT YOU TO UNDERSTAND WHAT THE LAYERS ARE. WE SOLICIT IDEAS ON SEMIANNUAL BASIS FROM ALL OUR INVESTIGATORS, BUT THE FORMS ARE AVAILABLE ONLINE AND WE ENCOURAGE EXTERNAL PEOPLE WHO ARE NOT PARTICIPANTS IN THE NETWORK PER SE TO SUBMIT IDEAS WE HAVE HAD PEOPLE DO SO. THAT'S A WONDERFUL THING. NETWORK CHAIRS CONDUCT INITIAL REVIEW ONLY JUST TO DECIDE DOES THE STUDY IDEA NEED TO BE EXPEDITED. IS A PUBLIC HEALTH IMPORTANCE TO MOVE IT OUT OF OUR REGULAR REVIEW PROCESS. BUT MOST IDEAS GO THROUGH OUR OPERATIONS GROUP REVIEW, AND WE WELCOME EACH SUBMITTER TO COME PRESENT IT DIRECTLY TO HAVE A VOICE HOW THEIR IDEA IS SHARED AND PRESENTED TO THE OPERATIONS GROUP WHICH THEN DISCUSSES THE SCIENTIFIC MERIT AND FEASIBILITY. THIS SERVES AS A VERY IMPORTANT INITIAL REVIEW IN OUR FUNNEL. WE HAVE HAD HUNDREDS OF IDEAS, SUBMITTED TO OUR NETWORK OVER TIME AND MANY OF THEM OVER TIME BECOME DUPLICATE OR DISCUSS THEM BEFORE, MAY NOT BE FEASIBLE SO THAT'S AN IMPORTANT FIRST STEP. WE DO TRY TO HAVE A LOW THRESHOLD FOR MOVING IDEAS FORWARD EVEN IF WE THINK THERE'S EVOLVING CONCEPT THAT CAN MOVE FORWARD OUT OF IDEA THAT'S SUBMITTED. TO OUR NETWORK INVESTIGATORS AT SEMIANNUAL MEETINGS BECAUSE WE WANT TO GAUGE THEIR ENTHUSIASM FOR THESE IDEAS. BASED ON INVESTIGATOR FEEDBACK THE IDEAS ARE THEN PRESENTED TO OUR EXECUTIVE COMMITTEE OUR GOVERNING BOARD AND PRIORITIZED BY THEM BASED ON AVAILABLE RESOURCES. WE LIKE THE DO AS MANY IDEAS AS WE POSSIBLY CAN. BUT THEY MAY SAY THIS IS A HIGHER PUBLIC HEALTH IMPACT OR WE THINK THIS IDEA NEEDS TO MOVE FORWARD. BASED ON EXECUTIVE COMMITTEE REVIEW, PROTOCOL DEVELOPMENT COMMITTEES ARE. TOED. -- ARE FORMED. FROM THE HUNDREDS OF IDEAS WE HAVE HAD 75 PRESENTED TO& EXECUTIVE COMMITTEE AND OUT OF THAT 30 PROTOCOL DEVELOPMENT OVER NETWORK HISTORY. SO THERE IS A GRADUAL FUNNELING DOWN. WE'RE NOT DONE THERE, PDCs PERFORM HEAVY WORK OVER THE NEXT SAY FEW MONTHS TO A YEAR TO CREATE INITIAL PROTOCOL DRAFT, AS COMPLETE AS WE CAN MAKE IT. AND THAT POINT WE RELEASE THE PROTOCOL AND HAVE OPEN REVIEW BY ALL OUR NETWORK INVESTIGATORS. WE ALSO ASK FOR VERY SPECIFIC DETAILED REVIEW, BY DESIGNATED EXECUTIVE COMMITTEE MEMBERS SO WE HAVE A VERY FRESH SCIENTIFIC LOOK. FROM THERE OUR REVISED PROTOCOL ACTUALLY GETS REVIEWED BY TWO INDEPENDENT COMMITTEES ONE IS NATIONAL EYE INSTITUTE APPOINTED EXTERNAL PROTOCOL REVIEW COMMITTEE, THIS IS AN INDEPENDENT COMMITTEE THAT LOOKS AT PROTOCOL REVIEWS IT, APPROVES IT AND REVISE IN RESPONSE TO EPRC COMMENTS. SECONDLY WE HAVE A DATA SAFETY MONITORING COMMITTEE THAT ALSO REVIEWS PROTOCOL SIMULTANEOUSLY OR AFTER PROTOCOL REVIEW AND REVISE AGAIN IN RESPONSE TO THE DSMC COMMENTS. ALL OF THIS LEADS TO A VERY RICH BACKGROUND OF SCIENTIFIC EXPERTISE DIVERSITY OF OPINION THROUGHOUT PROTOCOL DEVELOPMENT BEFORE FINAL DRCR NETWORK PROTOCOL. HAVING GONE THROUGH THAT I WILL URN THE IT TO DAN TO TALK ABOUT THE STUDY PIPELINE. >> THANK YOU, GOOD MORNING. WE ARE EFFICIENT. WE HAVE DONE 30 CLINICAL TRIALS IN 15 YEARS ENABLED BY ROBUST CLINICAL RESEARCH INFRASTRUCTURE. IT'S HOUSED AT THE -- CENTER IN TAMPA. THEY HAVE BEEN AROUND A LONG TIME, CONDUCTED WORLD CLASS CLINICAL TRIALS, EPIDEMIOLOGICAL RESEARCH OPHTHALMOLOGY AND DIABETES. THERE WERE MANY, MANY EFFICIENCIES HERE WHICH IS ENABLED BY NOT HAVING TO REINVENT THE WHEEL FOR EACH PROTOCOL. LOTS OF COMMON FEATURES ACROSS ALL STAGES OF DEVELOPMENT, AND A LOT OF THIS OCCURS SIMULTANEOUSLY. AN EXAMPLE OF THAT. RIGHT NOW THIS IS A MAP SHOT WHERE WE ARE IN VARIOUS PORTFOLIOS, WE'RE DOING THE ALL THESE THINGS IN PARALLEL, THEN SECONDARY MANUSCRIPTS FOR S AND T, CURRENTLY WRITING, WE WILL ANNOUNCE SOON A VERY IMPORTANT PROTOCOL, THAT (INAUDIBLE) WILL TOUCH ON WORKING ON THAT PRIMARY MANUSCRIPT NOW, DOING FOLLOW-UP FOR WAABB RECRUITING FOR AC AND AD WE'RE LAUNCHERRING AE AG AH AND AF AI AND AJ. CURRENTLY IN THE PROTOCOL DEVELOPMENT COMMITTEES YES, IT IS ALPHABET SOUP AND TOOK OOH WHILE -- IT DOESN'T TAKE LONG BECAUSE WE LIVE WITH THESE THINGS. BUT THIS IS RIGHT NOW, JUST THE SNAP SHOT OR ACTIVITY HAPPENING WITHIN THE NETWORK. WHICH ARE COST EFFECTIVE. WE HAVE DONE APPROXIMATE AMAZING JOB, BACK TO TWO, I WAS ONE OF THE FOUNDERS OF THIS NETWORK. I DON'T THINK WE IMAGINE HOW SUCCESSFUL WE WOULD BE ABLE TO LEVERAGE NIH DOLLARS WITH INDUSTRY AND FOUNDATION SUPPORT. A FEW EXAMPLES. WE HAVE STRICT GUIDELINES HOW WE DO THIS. THE NETWORK EXPLICITLY CONTROLS THE DESIGN IMPLEMENTATION AND REPORTING AND WE SERVE THE PUBLIC. WE DON'T -- WE ARE NOT HERE -- IF YOU CAN HELP BRING A DRUG TO MARKET, OKAY. BUT THAT'S NOT OUR AGENDA, WE SERVE THE PUBLIC. WE HAVE SEVEN COLLABORATIONS WITH INDUSTRY ON STUDIES THAT PROVIDE SCIENTIFIC EVIDENCE FOR THERAPEUTIC EFFICACY, GENERATED DATA TO SUPPORT FDA APPROVAL FOR NEW INDICATIONS THAT ALLOW COMPARISONS OF SAME CLASS AGENTS. SO BREAK DOWN OF OUR FUNDING WITHOUT DRUG COST, HALF COME FROM NEI, 20% FROM NIDDK, 30% FROM INDUSTRY, 3% JDRF, INDUSTRY COMPONENT TOTALS $40 MILLION SINCE THE NETWORK INCEPTION AND IF YOU ADD THE DRUG COST IN, IT'S HUGE. $117 MILLION OF SUPPORT FROM PHARMACEUTICAL INDUSTRY, SO WE PUT IN 30% NEI DOLLARS ABLE TO LEVERAGE ALL THE REST. SO -- GAVE BANG TO THE BUCK. WE'RE VERY PLEASED HOW ALL THIS HAS UNFOLDED. WE ARE PRODUCTIVE. WE HAVE HAD 220 POSTER AND PLATFORM PRESENTATIONS OVER THE CURSE OF OUR HISTORY. MORE THAN HUNDRED IN THE CURRENT GRANT CYCLE. IN 2018 WE HAVE 12 PRESENTED, WE HAVE SEVEN AT THE CAD MY AS WELL AS ANNUAL COURSE WE GET. WE PRESENTED 17 DIFFERENT NATIONAL INTERNATIONAL SOCIETY ANNUAL MEETINGS. THIS IS A LOOK AT NUMBER OF PUBLICATIONS WE HAVE PUT OUT OVER TIME. AND MORE THAN HALF OF THOSE 50 OF THOSE OCCURRED WITHIN THE CURRENT GRANT YEAR. FROM WE HAVE BEEN RECOGNIZED BY MANY ENTITIES, HERE IS A FEW, HOUSE OF REPRESENTATIVE APPROPRIATION BILL, THE NATIONAL EYE INSTITUTE DRCR YOU KNOW INVESTIGATIVE TREATMENTS, WE ARE RECOGNIZED AMONG EIGHT NIH FUNDED STUDIES CLINICAL BREAK THROUGH IN 2008, 2010 THE U.S. SENATE APPROPRIATION BILL RECOGNIZED COMPARATIVE EFFECTIVENESS CLINICAL TRIAL. IN 2011 WE WERE CITED FOR TANGIBLE SCIENTIFIC AND CLINICAL RESULTS FROM JDRF. IN 2012 U.S. SENATE APPROPRIATION COMMITTEE PROTOCOL EYE WHICH IS COMPARISON OF LASER AND ANTI-VEGF STEROIDS SHOWED -- SAW REVOLUTIONIZING STANDARD OF CARE FOR DIABETIC MACULAR EDEMA. PROTOCOL T WAS OUR FIRST -- WE NOT ONLY WERE ABLE TO INVOLVE ONE COMPANY WE SUCCESSFULLY MANAGED TO HAVE TWO COMPANIES AGREE TO PARTICIPATE IN MA CLINICAL TRIAL WHICH WE COMPLETELY CONTROLLED DESIGN, IMPLEMENTATION, THE INTERPRETATION OF THE RESULTS. THIS WAS I THINK A MARVELOUS EFFORT AND PRODUCED A CLINICAL TRIAL THAT TO THIS DAY CONTINUES TO SHAPE THE STANDARD OF CARE FOR DIABETIC MACULAR EDEMA, OF COURSE 2015 THE FIRST MAJOR -- NOT TREATMENT 40 YEARS OF PUBLICATION PROTOCOL S IN JAMA. LAST BUT NOT LEAST THE RECENT GRANT REVIEW SCORE WE WERE PLEASED TO RECEIVE 11 1/2 -- AND I HAVE TO READ THIS QUOTE BECAUSE WE WAPPED TO MAKE T-SHIRTS. OPPOSE ANY WAY SUPPORT FOR THIS CLINICAL TRIAL NETWORK WOULD BE EQUIVALENT OF IMPOSING MOTHER HOOD, APPLE PIE AND THE AMERICAN FLAG. WHAT ARE THE MAJOR GOALS FOR NEXT FIVE YEARS, JAMIE WILL TELL YOU HOW WE ENVISION IT. >> THANK YOU. SO THIS IS THE FUN PART OF THE TALK, LOOKING AT THE FUTURE AHEADS. I THINK AS -- SO I WILL TALK DIABETIC RETINOPATHY AND WHAT WE SEE COMING FORWARD IN THE PORTFOLIO OF STUDIES OVER THE NEXT FIVE YEARS AND FURTHER. AS WE DO THAT, LOOK INTO BE FUTURE WE HAVE TO BASE THAT INTO WHAT ARE THE CURRENT LANDSCAPE OF CARE AND WHAT ARE THE NEEDS? THOSE ARE WHAT WE NEED TO SHAPE RESEARCH PRIORITIES. THOUGH WE HAVE SHOWN GREAT ADVANCES IN CARE, THERE IS A HUGE UNMET NEED IN THAT DIABETIC RETINOPATHY REMAINS A LEADING CAUSE OF VISION LOSS WORLDWIDE. U.S. AND GLOBALLY. THIS IS DESPITE OUR OPTIMAL THERAPIES CURRENTLY. THERE ARE MANY REASONS WHY. 50% EYES WITH DIABETIC MACULAR EDEMA DON'T RESPOND FULLY TO ANTI-VEGF WHEN GIVEN IN CLINICAL TRIAL SETTING WITH REALLY PUSHING THE TREATMENTS REALLY PUSHING THE VISIT WINDOWS. WE HAVE A VERY INCOMPLETE UNDERSTANDING OF THE MECHANISMS BEHIND DIABETIC RETINOPATHY, AND THERE'S NO WAY WE CAN SCIENTIFICALLY AND INTELLIGENTLY DESIGN THERAPEUTIC ADVANCES UNLESS WE BETTER UNDERSTAND THOSE MECHANISMS. WE DON'T HAVE METHS TO PREVENT ONSET OR WORSE INFORMATION, THIS IS A CRITICAL NEED AS THERAPY FOR LATE STAGE DISEASE BET BETTER AND SCREENING TOOLS BETTER TO EDIFY PATIENTS WITH EARLIER ONSET DISEASE. WE WANT TO MOVE THE ENVELOPE SO WE STOP TREATING VISION ONCE LOSS AND PRESERVE BEFORE IT CHANGES. PATIENT DESPITE OUR BEST EFFORTS LOSE VISION ALL THE TIME BECAUSE OF TREATMENT COST ACCESS AND AVAILABLE ISSUE, WE HAVE LIMITED RESOURCES TO DEAL WITH EXPANDING GLOBAL BURDEN OF DIABETES AND DIABETIC RETINOPATHY. BY 2045 THERE WILL BE OVER 600 MILLION WORLDWIDE WITH DIABETES AND THERE'S A THREEFOLD INCREASE IN VISION THREATENING COMPLICATIONS FROM DIABETES IN THE U.S. ALONE AS ESTIMATE BIT THE CDC. WE NEED WAYS TO DEAL WITH THIS CREATIVELY BECAUSE WE DON'T HAVE THE MAN POWER THE WOMAN POWER TO DO THIS ON INDIVIDUAL BASIS. FINALLY, THERE IS A GAP BETWEEN CLINICAL TRIAL RESULTS AND REAL WORLD OUTCOMES WE HEAR THAT ALL THE TIME AND WE NEED TO FIND WAYS TO BRIDGE THAT GAP. SO HOW DO WE DO THIS? NUMBER ONE, WE NEED TO OPTIMIZE TREATMENT AND DEVELOP NEW MORE EFFECTIVE TREATMENT. I'M GOING TO SHOW YOU AS I MOVE THROUGH THIS CIRCLE WHAT THE NETWORK IS DOING AND WILL BE DOING OVER THE NEXT FIVE YEARS. WE HAVE STUDIES IN THIS AREA, PROTOCOL B WILL POINT OUT, NOT JUST THE LETTER BUT THIS IS OUR TRIAL LOOKING AT HOW DO WE MANAGE EYES WITH DIABETIC MACULAR EDEMA WITH GOOD VISION 2025 OR BEAR. DO WE NEED TO START INVASIVE TREATMENT ANTI-VEGF TREATMENT ONCE A YEAR OR MORE OR CAN WE WAIT AND RESCUE ANTI-VEGF LATER AND GET EQUIVALENT VISUAL OUTCOMES AND DO THESE EYES DO WELL WITH LASER NEVER NEEDING INVASIVE PROCEDURE? THAT WILL BE REPORTED THIS YEAR. OUR PROTOCOL AB IS FIRST RANDOMIZED SURGICAL TRIAL AND THIS IS LOOKING AT THE -- ANTI-VEGF HEMORRHAGE FROM EYES WITH DIABETIC RETINOPATHY. WE HAVE A LAUNCHING PROTOCOL AT PHOTO BIOMODULATION FOR DME. THIS IS AN EXCITING PROTOCOL BECAUSE IT'S INNOVATIVE, LOOKING AT LIGHT THERAPY, SOUNDS A LITTLE NUTS, WE KNOW THERE ARE LIGHT THERAPY DEVICES YOU WILL OVER SKY MALL AND SHARPER IMAGE BUT THERE'S NONETHELESS INTRIGUING BASIC PRE-CLINICAL EVIDENCE OF THAT, THAT PHOTO BIOMODULATION MODULATES OXIDATIVE STRESS RESPONSES OF THE RETINA AND MAY IMPROVE THINGS LIKE ACELLULAR CAPILLARY DEVELOPMENT, PARASITE LOSS, ENDOTHELIAL CELL MIGRATION AND LEAKAGE IN ANIMAL MODELS AND EARLY HUMAN EVIDENCE THAT THERE MAYBE SOME EFFECT BENEFICIAL IN EYES WITH DME SO THIS WILL BE A PHASE 2 STUDY AND SEE CAN THIS NON-INVASIVE WHAT WE THINK IS VERY SAFE, POTENTIALLY LOW COST CORTICAL ALTERNATIVE BE ALTERNATIVE IN EYES WITH GOOD VISION. LOOKING AT UNDERSTANDING OF MECHANISMS UNDERLYING DR WE HAVE INITIATIVES THAT SPAN ACROSS OUR STUDIES. WE ARE LOOKING AT EFFORTS TO BANK BLOOD FOR GENETICS TO LOOK AT GENETIC DISTRIBUTIONS, NOT JUST DR LEVEL, WHAT OUR NET WORK CAN ADD IS PHARMACOGENETICS IS TO LOOK AT ARE THERE TREATMENT RESPONSE IN EXQUISITELY PHENOTYPED COHORTS OF PATIENTS FOLLOWED OVER THE COURSE OF TREATMENT LONGS TERM. WE ALSO WILL CONTINUE TO ENCOURAGE BIOBANKING EFFORTS FROM ACROSS OUR STUDIES, PLASMA, VITREOUS, AQ3IUS, THESE ARE VALUABLE SAMPLES AND WE WANT TO MAKE SAMPLES AVAILABLE TO BASIC SCIENCE AN TRANSLATIONAL COLLABORATORS SO THEY CAN UNDERSTAND BETTER MECHANISMS AND AGAIN HELP NEW THERAPIES THROUGH THESE NOVEL MECHANISMS. IN TERMS OF EFFECTIVE STRATEGIES FOR DR AND DNE PREVENTION WE HAVE TWO LOOKING AT VISION THREATENING COMPLICATIONS, B PAR ALPHAING A NICHE, SHOWN PERHAPS EFFECTED IN CORE TRIAL THAT WAS NIH SPONSORED, FOR DIABETIC RETINOPATHY WORSENING. SO WE ARE LOOK AT NOVEL AGENT RATE FOR PREVENTION OF DR WORSENING IN EARLY STAGE DISEASE. OUR PROTOCOL AC IS LOOKING AT COST EFFECTIVENESS AND WE ARE SEEING ALTHOUGH IT'S CLEAR THAT THE -- DOES BET IN EYES WITH POOR VISION THERE ARE MEDICATIONS THAT DO VERY WELL WITH LOWER COST ALTERNATIVE SO CAN INITIATE TREATMENT AND USE IT AS A RESCUE THERAPY WITH THE SAME RESULTS WHILE HOPEFULLY SAVING QUITE A LOT OVER THE PUBLIC HEALTH SPECTRUM. PUBLIC HEALTH IMPLICATIONS ALSO IN TERMS OF DEVELOPING EFFICIENT METHODS FOR RETINOPATHY SCREENING AND RISK STRATIFICATION, PROTOCOL AA ARE LOOKING AT NEW TERRITORIES AN SEE CANNING WE USE LESIONS TO IMPROVE OUR ABILITY TO STAGE RISK OF RETINOPATHY WORSENING AND DEVELOPMENT OF VISION LOSS IN OUR PATIENTS WITH DIABETES. THIS COULD CHANGE THE WHOLE SPECTRUM HOW WE DIABETIC RETINOPATHY THERAPY. WE'RE JUST BEGINNING EFFORTS TO LEVERAGE OUR DATA SET OR STUDY DATA SETS AT CLINICAL IMAGES TO WORK WITH GROUPS THAT HAD ESTABLISHED EXPERTISE IN ARTIFICIAL INTELLIGENCE TO MAKE THOSE AVAILABLE TO HELP MOVE FORWARD THOSE EFFORTS IN TERMS OF NOT JUST DR DETECTION BUT AGAIN WHERE WE NEED TO GO IN TERMS OF PREDICTION OUTCOMES OVER LONG TERM. FINALLY WE LIKE THE THINK CLINICAL TRIAL RESEARCH SHOULD BE DONE TO CHANGE REAL WORLD OUTCOMES NOT IN RESPONSE TO REAL WORLD OUTCOME BUT NOT NECESSARILY, WE NEED TO UNDERSTAND PRACTICE PATTERNS THAT INFLUENCE OUTCOMES ONCE MOVE OUT OF CLINICAL TRIALS INTO CLINICAL CARE. SO WE ARE BRINGING BACK PROTOCOL T PARTICIPANTS FOR FIVE YEAR VISITS SO WE UNDERSTAND HOW THEY DO ONCE THEY LEAVE THE CLINICAL TRIAL SETTING AND MOVE TO STANDARD CARE AND CAN THAT CHANGE HOW WE THINK ABOUT HOW DESIGN TRIALS GOING FORWARD. WE ARE PARTNERING WITH THE AMERICAN ACADEMY OF OPHTHALMOLOGY AND EYE REGISTRY ELECTRONIC HEALTHCARE DATA ACROSS MULTIPLE PRACTICES ACROSS U.S. TO BETTER DESIGN STUDY QUESTIONS DOWN THE ROAD. SO THE GOAL IS PRESERVATION OF VISION AND ALL OUR PATIENTS WITH DIABETES. I'M NOT GOING TO GO THROUGH THE NEXT FEW SLIDES IN DETAIL, THIS IS SNAP SHOT OF ONGOING STUDIES, LOOKING AT STUDY DESIGN, GROUPS TO GIVE YOU A SENSE THERE'S A LOT OF WORK GOING ON AND WILL BE GOING ON THROUGH THE NEXT FIVE YEARS TO KEEP US BUSY. I THINK WHAT'S MORE IMPORTANT IS LOOKING AT WHAT IS THE POTENTIAL IMPACT OF ALL THESE STUDIES. THESE IMPACTS RANGE, WON'T GO THROUGH DETAILS BUT THEY RANGE FROM LOOKING AT PREVENTIVE STRATEGIES FOR RETINOPATHY WORSENING VISUAL ACUITY LOSS TO NEW EFFECTIVE AND INNOVATIVE TREATMENTS TO BIOMARKERS AND TO EFFORTS THAT MAY HELP SUPPORT THE TRANSLATION OF BENCH TO BEDSIDE RESEARCH, PROVIDING EARLIER LOOKS AT WHAT HAPPENS IS THERE A HUMAN SIGNAL THAT CAN THEN HELP IDENTIFY PATHWAYS THAT ARE MORE IMPORTANT OR PERHAPS LESS IMPORTANT TO PURSUE. OUR INITIATIVES THAT SPAN OUR NETWORK TRIALS ALSO HAVE MAJOR POTENTIAL IMPACTS IN TERMS OF IDENTIFYING GENETIC CONTRIBUTIONS, BIOMARKERS, AND LOOKING AT LARGE SCALE SCREENING METHODS FOR RETINOPATHY, PREDICTION DISEASE, YOU COMES, SO I HOPE WE HAVE LEFT YOU WITH THE IDEA THAT THE NETWORK HAS A VERY ROBUST ONGOING BODY OF WORK IN DIABETIC EYE DISEASE, WE WILL BE BUSY, WE ARE BUSY, THERE'S A HECK OF A LOT OF WORK TO BE DONE, AND THESE ARE POTENTIAL FUTURE STUDIES WE CONSIDER MOVING FORWARD, ALWAYS INTERESTED IN NOVEL THERAPY FOR D ALREADY AND DME AS THE FIELD MOVES WE ARE MOVING WITH IT AND HOPEFULLY MOVING AHEAD SO WE CAN HELP BRING NEW THERAPIES TO OUR PATIENTS. I THINK THERE'S A LOT OF SPACE TO LOOK AT INTERACTIONS BETWEEN THE EYE AND THE REST OF THE BODY, NOT JUST IN HOW DOES RETINAL NEURAL AND VASCULAR CHANGES REFLECT RANGE FUNCTION AND STRUCTURE IN PATIENTS WITH DIABETES BUT ALSO SYSTEMIC COMORBIDITIES OF PATIENTS WITH DIABETES. WE'LL NEED TO TEST IMPLEMENTATION OF ARTIFICIAL INTELLIGENCE ALGORITHMS IN OUR CLINICAL CARE PRACTICE, THAT NEEDS PROSPECTIVE STUDIES GOING FORWARD. EVENTUALLY WE ARE OPEN TO LOOKING AT REGENERATIVE APPROACHES TO DIABETIC EYE DISEASE THAT MAYBE EARLY AT THIS POINT BUT AT SOME POINT IN TIME AS THOSE APPROACHES ARE DEVELOPED THROUGH SOME OF THE FUNDING MECHANISMS NEI HAS AND COLLABORATIVE APPROACHES WE WOULD LOVE TO TEST THESE THROUGH OUR MULTI-CENTER CLINICAL TRIAL RESEARCH NETWORKS AS WELL. I WILL YIELD TO DAN TO TALK ABOUT OUR FUTURE DIRECTIONS IN AMD AND OTHER RETINAL DISEASE. >> SO WE LABELED THIS AMD RETINAL DISEASE, BECAUSE AS WE MOVE -- LAST YEAR, WE WERE THE NETWORK WAS EXPANDED, TO COVER ALL RETINAL DISEASE. AND AND IS PROBABLY A FOCUS AS WE GO FORWARD. IT'S IMPORTANT I THINK TO LOOK TOWARD -- BEFORE WE GO FURTHER, I WANT TO TALK ABOUT WHY IT'S IMPORTANT THAT WE EXPAND AND WHY IT'S IMPORTANT TO HAVE AND ALL RETINA CLINICAL TRIAL NETWORK? PHARMACEUTICAL COMPANIES ARE NOT THE HE WILL IS SOURCE OF FUNDING FOR RETINAL CLINCAL TRIALS BECAUSE NEEDS OF PHARMA TO ACHIEVE DRUG APPROVAL NEEDS POSITION HOW THEY USE DRUG ARE DIFFERENT. THEY'RE VERY DIFFERENT. REGISTRATION TRIALS RARELY INFORM PATIENTS AND PHYSICIAN WITH OPTIMAL USE OF DRUG. FURTHER TRIALS FREAKILY COMPARE TO SINGLE STANDARD OF CARE BUT RARELY COME MARE MULTIPLE DRUGS AND FINALLY AFTER DRUG IS APPROVED CLINICAL TRIAL PERSONNEL AND RESOURCES WITHIN THE COMPANY ARE USUALLY DEPLOYED TO P NEW PROJECTS LEAVING MINIMAL RESOURCES TO EXPLORES SECONDARY OUTCOMES. AS A RESULT THINK ABOUT THE REGISTRATION TRIALS FOR EXAMPLE, RISE AND RIDE WHICH ARE THE TWO TRIALS THAT WILL LED TO FDA APPROVE OF MACULAR EDDY MARKS A TOTAL OF FOUR, FIVE PUBLICATIONS THAT COME OUT OF THOSE PAPERS. REGISTRATION TRIALS FOR EDEMA -- NEOVASCULAR AMD. FIVE OF SIX PAPERS OUT OF THOSE, WHEREAS LOOK AT PROTOCOL I WHICH WAS TIE BETTIC MACULAR EDEMA,'S 15 PUBLICATIONS. LOOK AT HAT UP TO 54 PUBLISHED PAPERS EDITORIALS AND COMMENTARIES OPPOSED TO FOUR OR FIVE. THESE CLINICAL TRIALS CONTAIN A DROVE OF INFORMATION BUT THE RESOURCES TO EXPLORE THAT USUALLY DON'T PERSIST IN COMPANIES AND IT IS JUST CRITICAL A CLINICAL TRIAL NETWORK IS ABLE TO GO IN AND DO WORK. DIABETIC RETINOPATHY TREATMENT IS ENHANCED BY WORK OF DRCR NETWORK. EVERY DISEASE HAS ITS SIMILAR KNOLL MOMENT WITH CONCERN GENERALS OF DISCOVERIES THAT MAKE IT AN IMPORTANT TRIAL TO PERFORM, PROTOCOL T AND S AND CAT. CURRENTLY THE MOST ROBUST AREA OF DRUG DEVELOPMENT, AFTER DELIVERY OF RETINA IS NEOVASCULAR AMD SO THE NETWORK NEEDS TO BE POISED TO ANSWER QUESTIONS WHENEVER THEY ARISE WITHIN RETINAL DISEASE. HERE IS AN EXAMPLE OF HOW ROBUST THE DEVELOPMENT OF NEOVASCULAR AND, THESE ARE DRUGS IN PHASE 2 OR 3 CLINICAL TRIALS. MANY OF THESE MOVE ON TO BE EDEMA, I CAN PUT UP A CHART THAT LOOKS LIKE THIS ALSO FOR AMD SO THE OPPORTUNITY FOR COMPARATIVE TRIALS WITH THE OPPORTUNITY FOR COLLABORATION WITH PUBLICLY FUNDED NETWORK BECOMES VERY OBVIOUS VERY FAST. WE SPENT A LOT OF TIME OVER THE LAST COUPLE OF -- LAST YEAR OR SO TRYING TO DECIDE WHAT IS OUR FIRST MAJOR AND TRIAL. IT'S BECOME CLEAR TO US THAT AREA A LOT OF PEOPLE LOVE TO EXPLORE HAS WELL EXPLORED YET IS A STUDY THAT LOOK AT PREVENTION OF VASCULARIZATION IN AMD. SO WE LOOK AT CAT, IT'S TRUE A LOT OF DISEASES, THE BETTER THE VISUAL ACUITY AT THE TIME OF DIAGNOSIS, THE BETTER THE VISUAL OUTCOME. SO IT MAKES A LOT OF SENSE TO BACK UP BEFORE YOU DEVELOP DISEASE, BEFORE YOU HAD FIBROTIC CHANGE OR CHANGES TO THE THINGS FIBROTIC CHANGES OR CORTICAL VASCULARIZATION THAT INFILTRATES THE SUBRPE AND RPE SPACE BEFORE THESE HAPPEN IT MAKES SENSE CAN YOU PREVENT IT ALL TOGETHER? SO THIS IS A CURRENT STUDY THAT WE'RE WORKING THROUGH, IT'S STILL IN EVOLUTION BUT WE ARE GETTING CLOSE, LARGE CLINICAL TRIAL THAT WOULD LOOK AT PATIENTS WHO HAVE HIGH RISK BASICALLY A VASCULARIZATION ONE EYE, HIGH RISK DRIVE AND WE LOOK TO INJECT AN ANTI-VEGF DRUG AT SOME FREQUENCY. QUO, Q3 VERSUS YOUR Q 6 WITH SHAM Q3 WITH DEVELOPMENT OF VASCULARIZATION OF STUDY EYE OCT. STUDY ALSO INCLUDE IMPORTANT SUBSTUDY. WE HAVE A REALLY NEW ENTITY BUT WE NOW RECOGNIZE EXIST MORE OFTEN THAN WE PREVIOUSLY KNEW, THAT IS THE APPEARANCE, THE OCCURRENCE OF NON-EXUDATED SUBCLINICAL C AND D. WE KNOW 5 TO 20% HIGH RISK GUYS HARBOR ON OCTA BUT THE FIRST TIME WE CAN IMAGE, WE HAVE ACTUALLY KNOWN IT WAS THERE, WE GO BACK TO STUDIES IN 1990s WE HAVE KNOWN THIS WAS THERE. SUBCORTICAL VASCULAR MEMBRANES. WE DON'T KNOW WHY, BUT THEY'RE THERE. AND WE KNOW IF THEY ARE THERE, THEY'RE ASSOCIATED WITH INCREASE RISK FOR EXUDATED NEOVASCULAR AND AND UNKNOWN WHETHER WE SHOULD TREAT THOSE OR NOT. IF PREVENTION IS EFFECTIVE WE ALSO DON'T KNOW IF THESE EYES THESE HE'SES REQUIRE A DIFFERENT DOSING TO BE EFFECTIVE. SO ONE OF THE SUBSTUDIES THAT WE HAVE LAYERED INTO THIS LARGER CLINICAL TRIAL IS OCTA ANCILLARY STUDY WE DETERMINE FREQUENCY AND CLINICAL IMPORTANCE OF NON-EXDAYTIVE EVERY SINGLE RETINA YOU GO TO RIGHT NOW, THERE'S PROBABLY MORE CONVERSATION ABOUT THIS THAN ANY TOPIC YOU CAN NAME. IT IS -- WE SEE ENTIRE DAY LONG MEETINGS ABOUT OCTA AND ITS APPLICATION OPHTHALMOLOGY, THE BIGGEST FOCUS IS IDENTIFICATION NON-EXUDATED C -- WE NEED TO UNDERSTAND THE NATURAL HISTORY OF THESE LEAGUES. WE DON'T KNOW, THERE'S A LOT OF SMALL STUDIES, IT'S INCUMBENT ON NETWORK LIKE OURS TO UNDERSTAND THAT. WE CAN DO THAT BY BUILDING THIS SUBSTUDY INFO A LARGER TREATMENT TRIAL. OCTA IT WOULD BE OBTAINED EVERY THREE MONTHS ALONG STRUCTURAL OCT WITH THE -- THE OUTCOMES ARE -- GROWTH OF MACULAR -- IT'S POSSIBLE THAT TREATMENT OF THESE SUBCLINICAL MEMBRANES WHICH ARE HIGH RISK TO GO ON TO -- IT'S POSSIBLE CAN YOU MIGHT PUSH THESE LEAGUES INTO GEOGRAPHIC ATROPHY. THERE'S SOME EVIDENCE THAT IN FACT MAYBE THE CASE. IT'S IMPORTANT IT'S REALLY UNKNOWN. AGAIN, GOING TO TAKE A NETWORK STUDY LIKE THIS, TO ELUCIDATE THAT. ONE OF THE DISEASES MIGHT WE STUDY, NEOVASCULAR AMD AS I MENTIONED WE ARE GOING TO DO TWO SMALL TRIALS AT (INDISCERNIBLE) SO OF ALL THE PROTOCOL IDEAS THAT WE'RE GETTING FROM OUR INVESTIGATORS, MAJORITY OF THEM NOW ARE NON-DIABETIC RETINOPATHY THE -- IS SO EXCITED ABOUT THE POSSIBILITIES THAT IN FRONT OF US. BEYOND AFTER NEOVASCULAR DRY ANT THE ONE WE GET ASKED MORE PROTOCOLS SUBMITTED ON -- RETINOPATHY. THIS IS A DISEASE THAT IS POORLY UNDERSTOOD, IT HAS NEVER BEEN A LARGE CLINICAL TRIAL TO TELL US HOW WE SHOULD BE TREATING THIS DISEASE. SO -- PHOTO DYNAMIC THERAPY, THAT'S DATA OUT THERE ON THAT BUT IT'S THE PRODUCT FORMS. WE HAVE COUPLE OF NEW TREATMENTS WE'RE ALL USING, AND THEN -- IS ANOTHER ONE. WE ARE CURRENTLY DEVELOPING A TRIAL TO LOOK AT ONE OR BOTH OF THESE TREATMENTS FOR CHRONIC CENTRAL CIRRUS, RETINOPATHY PREMATURITY, THERE'S A PROMISING DRUG FROM THE PIPELINE, WE OTHER DOING SURGICAL TRIALS, THAT HAVE BEEN PROPOSED AND I CLOSE THIS OUT BY PUTTING OTHER RETINAL DISEASES. WE HAVE SO MANY PROTOCOL IDEAS. SUBMITTED TO US. VERY NICELY SHOWED YOU, VERY FEW PROTOCOLS EVER MAKE IT. IT'S A RIGOROUS PROCESS. THAT WE GO THROUGH AND TAKES A LONG TIME TO WORK THROUGH IT. BUT IT'S A VERY EXCITING TIME FOR THE NETWORK AND WE ARE THANK YOU FOR THE SUPPORT, WE THANK YOU FOR ALLOWING US TO EXPAND THE NETWORK AND WE WANT TO MAKE SURE WE BEST SUPPORT REFLECTING THE PRIORITY OVER THE NEXT FIVE YEARS. WE'RE HAPPY THE TAKE QUESTIONS. PLEASE. >> I HAVE A QUESTION. SO IF THE NETWORK IS GOING TO EXPAND TO ALL RETINAL DISEASES, MAYBE SOME OF THAT WOULD UNCOLLUDE PEDIATRIC DISEASE. I CAN SEE THAT IT COULD SET UP COMPETITION. SO YOU HAVE CLINIC SCIENTIST OR SMALL GROUP OF CLINICIAN SCIENTISTS WHO HAVE AN IDEA AND THEY WANT TO PURSUE IT ON THEIR OWN. IS THERE SOME PRESSURE FROM THE NETWORK TO DO IT THROUGH THE NETWORK. AND IF THEY DECIDE TO DO IT THROUGH THE NETWORK IS THERE SOME WAY WOULD THERE BE SOME WAY THEY CAN SOMEHOW RETAIN OWNERSHIP OF THEIR IDEA OR IMPLEMENTATION, ET CETERA. >> SO I THINK COUPLE OF THINGS GO INTO THAT ANSWER. ONE QUESTION IS IF WE'RE GETTING IDEAS WHERE THERE OVERLAP, PERHAPS WHAT WE CAN DO, OTHER NETWORKS CAN DO, GROUPS CAN DO, OUR INTEREST IS ALWAYS SUPPORTING SCIENCE MOVING IT FORWARD AND THERE WILL BE MANY IDEAS, PEDIATRIC FROM EYE DISEASE RETINA SITES MAY NOT BE THE BEST FEASIBLE WAYS TO MOVE IT FORWARD. BUT CAN SERVE AS REFERRAL CENTERS FOR THE PATIENTS THAT WERE IDENTIFYING AND WE OTHER HAPPY TO COLLABORATE WITH OTHER GROUPS IF WE CAN HELP IN A DISEASE AREA WHERE AGAIN WITH DON'T HAVE EXTREME EXPERTISE. DOESN'T FALL TO A GENERAL RETINA BUT WHERE ARE EFFORTS CAN HELP THAT. IN TERMS OF IDEA OWNERSHIP, ANY TIME SOMEONE BRINGS AN IDEA TO US, WE TRY REALLY HARD TO KEEP THEM INVOLVED IN SUBSEQUENT PROTOCOL DEVELOPMENT PROCESS, IN THE PERFORMANCE OF THAT PROTOCOL, SO MANY CLINICIANS THAT POSE IDEAS ARE UNDERSTANDABLY MOST ENTHUSIASTIC ABOUT IDEAS BEING OUR HIGHEST RECRUITERS. SO FORTH. WHEN'S EXTERNAL GROUPS WE KEEP THEM ON PROTOCOL DEVELOPMENT COMMITTEES, AS PROTOCOL MOVES FORWARD, HAPPY TO INVOLVE IN MANUSCRIPT PROCESSES. IF THE QUESTION IS ABOUT INTELLECTUAL PROPERTY, THERE WE HAVE NEVER -- WE ARE NOT LOOKING TO TAKE ANYONE'S INTELLECTUAL PROPERTY. SO IN INDUSTRY COLLABORATION, WE DON'T TAKE OWNERSHIP OF, WE DON'T THINK IT'S APPROPRIATE FOR US TO DO THAT. AND WE THINK ACTUALLY WE WANT IT TO BE CLEAR ON OUR PARTS. THAT'S CRITICAL FOR US, WE WANT TO MAKE THAT DIVISION CLEAR. >> IT'S A GREAT QUESTION. IT WAS SUBJECT OF OUR CONFERENCE CALL LAST WEEK T. SO I WOULDN'T SAY IT'S A VERY -- THERE'S LOT OF DIFFERENT WAYS THAT THAT COULD GO. SO I WOULD SAY THAT WE DON'T HAVE -- I DON'T HAVE A SINGLE ANSWER THAT I CAN PROVIDE WITH THAT. BECAUSE THE NUMBER OF SCENARIOS WE'RE GOING TO ENCOUNTER ARE QUITE DISPARATE. GENERAL PRINCIPLE IS JUST AS JENNY SAID WE ARE NOT LOOKING TO TAKE SOMEONE'S IDEAS BUT IF IT IS SOMEONE'S IDEA THAT MOVE THROUGH P POTENTIAL COMMERCIALIZATION IN THAT INDIVIDUAL CLEARLY THIS -- WE ARE STRICT ON CONFLICT OF INTEREST ISSUES. RULES, AND PROBABLY THAT INVESTIGATOR WOULD NOT BE INVOLVED IN FURTHER CLINICAL TRIALS IF THERE WAS COMMERCIALIZATION ASPECT. IS THAT WHAT YOU WERE GETTING AT? IT'S A VERY INTERESTING TOPIC TO THINK THROUGH. AGAIN, I GO BACK TO INITIAL WHAT WE SERVE THE PUBLIC. SO WE ARE REALLY FRONT AND CENTER. AT THE SAME TIME WE WANT THE SEE IMPORTANT DRUGS MOVE FORWARD. AT THE END OF THE DAY NO DRUG EVER MAKES IT COMMERCIAL PARTNER. -- WITHOUT A COMMERCIAL PARTNER SO IT WILL BE INTERESTING AS WE EXPAND TO MORE OPPORTUNITIES TO COME UP, BE INTERESTING HOW WE EXEXPLORE THOSE. >> GREAT PRESENTATION, REALLY REMARKABLE PROGRAM. TWO QUESTIONS, ONE IS WITH THE VERY ROBUST MECHANISM FOR PROTOCOL INITIATION DEVELOPMENT AND SO FORTH. HOW DO WE PROTECT AGAINST OVER COMMITTEIZATION OF PROTOCOLS, IT'S EASY TO CREATE PROTOCOLS BY COMMITTEE THAT END UP IN FUNNY PLACES I THINK BACK TO ETDRS AND DEFINITION OF CLINICAL SIGNIFICANT DIABETIC MACULAR EDEMA WHICH COULD GEE THEM OUT OF ECONOMY AND FIELD FOR A LONG, LONG TIME BECAUSE OF THE WAY IT WAS FORMULATED. HOW DO YOU -- THAT TYPE OF ISSUE >> WE PUT A CHECK ON THAT BECAUSE WE DO INVOLVE ALL O OUR INVESTIGATORS. AND OUR INVESTIGATORS ARE LOCAL. RETINA SPECIALISTS, THEY WILL TELL YOU. YOU KNOW THAT. SO WE DO TRY AND GAUGE THEM, WE TRY TO MAKE SURE THEY GET EMAILS BUT ALSO -- THESE ARE THE RULES COMING UP, WATCH FOR THIS MAN EWE SCRIPT FOR THIS PROTOCOL. WE WANT TO KNOW IF SOMETHING WEAR SAYING IS NOT GOING TRANSLATE WELL IN CLINICAL PRACTICE IT'S IMPORTANT TO CONSIDER AS WE DEVELOP PROTOCOL. >> THIS IS ALL 20 YEARS AGO BUT EBS AND USE OF -- AS THE ANTIBIOTIC USING THAT CAME OUT OF NOWHERE AND -- OFF TO THE SIDE. THE SECOND QUESTION YOU ALLUDED TO WHICH IS CONFLICT OF INTEREST POLICY, SO WITH YOUR, DAN, YOUR MINE BASICALLY EVERY PHARMA GROUP, PHARMA COMPANY IN THE OPTHALMIC SPACE AND MANY WHO HAVEN'T BEEN IN OPTHALMIC SPACE, I DIDN'T KNOW SAMSUNG WAS -- CONFLICT OF INTEREST WITH OUR COMPUTER MONITORS HERE. GOING TO MEETINGS NOW, THE WAY I CAN TELL I'M STILL 2020 OR BETTER IS BY READING THE DISCLOSURE SLIDE IN MOST RETINA TALKS. AND IT'S REALLY AN ISSUE. BECAUSE YOU HAVE EVERYONE PLAYENING THE SPACE, YOU ARE IN COMPANIES, AND YOU HAVE A LOT OF INVESTIGATORS WHO DO HAVE A LOT OF TIES TO INDUSTRY. SO HOW DO YOU BRIGHT LINE THAT, IT WOULD SEEM DIFFICULT TO SAY NO CONSULTING AGREEMENTS OR WHATEVER, BUT IT'S ALSO EASY TO HAVE PEOPLE IN STUDIES WHO DO HAVE CONFLICT OF INTEREST. >> SO YOU ARE RIGHT. ESPECIALLY WITH THE RETINA COMMUNITY, IT'S VERY DIFFICULT TO JUST SAY WE WON'T COLLABORATE WITH ANYBODY WITH THAT RELATIONSHIP. SO WE HAVE A STRICT POLICY IN PLACE, NONE OF THE LEADER SHIP CAN HAVE ANY RELATIONSHIP WITH THE COMPANY, WE WORK WITH DRCR NET AND WE CANNOT TAKE ANY MONEY FROM THEM OUTSIDE THE NETWORK. SO THAT GOES FOR THE THREE OF US. ALSO GOES FOR OUR OUR OPERATIONS GROUP WHICH DEALS WITH DAY TO DAY INVOLVEMENT OF THE NETWORK, ALSO ON OUR DEVELOPMENT COMMITTEES. PROTOCOL DEVELOPMENT IS TRICKIER BECAUSE WE NEED OUTSIDE EXPERTISE IS WE MAINTAIN AT LEAST MAJORITY OF THOSE INDIVIDUALS ON THOSE COMMITTEE ALSO NOT HAVE CONFLICTS WHATSOEVER. SO WE HAVE A MAJORITY MAKING DECISIONS THAT ARE UNCONFLICTED. FOR MAN EWE IS SCRIPT WRITING SAME APPROACH IS TAKEN. SO WE MAKE SURE WE HAVE CLEAN GROUPS AT LEAST MAJORITY OF THAT. IN TERMS OF RECRUITING PARTICIPANTS AND BEING INVOLVED WITH THE NETWORK THERE WERE CERTAINLY TO HAVE INVOLVEMENT IN PEOPLE THAT WILL ARE IN INDUSTRY TRIALS COLLABORATING WITH INDUSTRY AS WELL AS INSIDE THE NETWORK. NUMBER OF PARTICIPANTS, 10% RECRUITMENT INTO A STUDY, TO MAKE SURE ANY INVOLVEMENT THEY HAVE IS MITIGATED BY THESE RULES. (OFF MIC) VERSUS (INAUDIBLE) ADVANCE AND I WAS CONFLICTED ABOUT HOW TO ADVISE HIM BECAUSE (INAUDIBLE) -- SUBMITTING AUTHOR ON PAPER. SO I'M JUST WONDERING HOW YOU ADVISE PEOPLE CLINICIANS LOWER LEVELS OF ACADEMIC -- WHAT THEY SHOULD DO IN TERMS OF HOW MUCH INVOLVEMENT WITH CONSORTIA VERSUS HAVING YOUR OWN WORK. >> IT IS THE AGE OLD QUESTION. BECAUSE RANDOMIZED CLINICAL TRIALS IS ADEEM DRAFF CATTIC PROCESS AND PEOPLE WHO FIND OUT TOP GET WAY MORE CREDIT THAN REALLY SHOULD. AND PEOPLE WHO MAY HAVE -- MAYBE THERE WERE 15, HARD TO REALLY ESTIMATE CONTRIBUTION, ONE THINGS WE HAVE DONE IS -- ONE NICE THING ABOUT OUR NETWORK IS WE INVOLVE SO MANY OTHER PEOPLE IT STARTS WITH THE POT PROTOCOL CHAIRS. JENNY AND I ARE NOT PROTOCOL CHAIRS THOUGH THE TRIAL COME TO US WITH AN IDEA, BUT SOMETIMES ONE OF THE FIRST ONES CAME TO US WITH AN IDEA. SOMEONE VERY INVOLVED WITH THE NETWORK, VERY ENGAGED WITH THE GROUP WE LIKED TO PROMOTE THEM TO THE POINT WHERE THEY ARE -- THEY WILL BECOME A PROTOCOL CHAIR. PROACTIVE IN TERMS OF HOW WE PROMOTE THAT, THERE'S STILL A FINITE NUMBER OF LEADERSHIP ROLES WE ALWAYS ARE ASK OURSELVES HOW TO CREATE MORE OPPORTUNITIES. IT'S A BIGGER OPPORTUNITY THAN JUST A SINGLE CLINICAL TRIALS NETWORK. SINGLE CLINICAL TRIAL. BUT IT'S >> LET ME ALSO SAY THINK THE NICE THING IS NOT ONLY IS IT NOT MUTUALLY EXCLUSIVE TO PARTICIPATE IN NETWORK MEANINGFULLY AND OWN EXCELLENT INDIVIDUAL RESEARCH. BUT THEY HELP INFORM EACH OTHER. IT'S INCREDIBLY I WILL SPEAK FROM MY PERSONAL EXPERIENCE, I CAME TO NETWORK AS INVESTIGATOR FRESH OUT OF FELLOWSHIP AND MY PARTICIPATION IN NETWORK TAUGHT ME SO MUCH ABOUT DESIGNING RESEARCH IN GENERAL. AND I HAVE MY OWN INDIVIDUAL PROJECTS THAT I RO1 SUPPORT FROM NEI, AND IT WAS THAT INTERACTION BETWEEN WATCHING HOW THINGS ARE TRANSLATED INTO MULTI-CENTER CLINICAL TRIALS THAT HAS CHANGED AROUND HOW I HAVE BEEN DESIGN MY OWN RESEARCH IN BIOMARKERS AN IMAGING. I THINK THE OPPORTUNITIES INVOLVED IN THE NETWORK NICE THING IS AS DAN SAID WE TRY TO GET PEOPLE INVOLVED EARLY AND IT'S RELATIVELY EASY AS HIGH RECRUITER IN PARTICULAR TO MOVE UP THE LADDER OF GETTING INVOLVED. SO IT'S A NICE WAY OF GETTING EARLY RECOGNITION AS YOUNG INVESTIGATOR AND SUPPORT AROUND YOU AND ACCESS TO MENTORS LEADERS IN THE FIELDS THAT I THINK CAN HELP YOUR OWN RESEARCH. >> THERE ARE A NUMBER OF PEOPLE WHO ARE IN PRIVATE PRACTICE, MAJORITY OF SITES ARE PRIVATE PRACTICE SITES. WHO REALLY BLOSSOMED. I DON'T THINK THEY SAW THEMSELVES EVER BEING ON PODIUM PRESENTING NATIONAL CLINICAL TRIAL RESULTS. JACK WELLS, CARLS BAKER. THERE IS A NUMBER OF PEOPLE WHO HAVE DONE AMAZING JOB. SO THE OPPORTUNITIES ARE THERE. SO I WOULD HOPE YOU WOULD ENCOURAGE YOUR INDIVIDUALS TO PARTICIPATE IN THE NETWORK. WE'RE CERTAINLY SENSITIVE TO IT. WE DON'T HAVE THE PERFECT ANSWER. BUT I THINK WE OFFER A LOT OF OPPORTUNITY. >> I THINK IT'S USEFUL, I REVIEWED CANDIDATES WHO HAVE BEEN IN THESE GROUPS. USEFUL IF A LETTER FROM SOMEONE IN ADMINISTRATIVE LEVEL TO COMMITTEE CAN DEFINE THE EXACT ROLE OF THE INDIVIDUAL PLAYED IN THAT COMMITTEE. FOR OUR PROMOTION COMMITTEE SO WE CAN UNDERSTAND EXACTLY WHERE THEY COMING FROM BUT I DON'T KNOW THE MECHANISM FOR THAT KIND OF INVOLVEMENT. >> THAT'S A REALLY INTERESTING THOUGHT WE HAD A LOT OF CONVERSATIONS RECENTLY ABOUT PARTICULARLY JUNIOR INVESTIGATOR DEVELOPMENT. IT'S SOMETHING WE CAN OFFER TO OUR INVESTIGATORS TO MAKE AWARE. >> WE ALSO DO A FAIR NUMBER OF EDUCATIONAL THINGS WITHIN OUR GROUP, EVERY ONE OUR TWICE A YEAR MEETINGS WE HAVE A FUNDAMENTAL CLINICAL TRIALS WORKSHOP TRYING TO EDUCATE PEOPLE, GET THEM INVOLVED IN THIS HAS DEEPLY AS THEY WANT TO BE. >> THANK YOU FOR TAKING TIME OUT YOUR PRACTICES TO COME. THAT WAS VERY INFORMATIVE. PROCESS USUALLY ISN'T ALL THAT INTERESTING BE THIS WAS. >> THANK YOU. [APPLAUSE] >> THE AGENDA NOW SHOWS A FEW MINUTES FOR COUNCIL SESSION. >> BEFORE WE TURN TO COUNCIL DISCUSSION I WANT TO TAKE RESPONSIBILITY FOR THE CONFUSION, I GAVE MY BOSS THAT DATA, THE PEOPLE WHO ARE RETIRING NEXT YEAR. THEY READ THE -- ARE LOOKING FORWARD TO SEEING YOU AGAIN IN JANUARY AND IN OCTOBER. HOWEVER, WE WILL NOT BE SEEING (INDISCERNIBLE) SO THIS IS AS MUCH TO TELL THEM. THEY ARE OFF THE HOOK TO IT WILL YOU ALL THAT YOU ARE NOT, MY APOLOGIES. >> NOT BAD. THE ONLY MISTAKE NEI MADE THIS YEAR. >> WITH THAT THERE'S OPENING TOPIC FOR ITEMS YOU WOULD LIKE TO BRING UP. I WILL JUST SAY THAT WE'RE STILL IN OPEN SESSION SO PLEASE DON'T TALK ABOUT ANY SPECIFIC GRANTS APPLICATIONS. >> I HAVE A QUESTION ABOUT DEFINITION OF A CLINICAL TRIAL. ANY UPDATES ON WHERE THAT IS? >> CONGRATULATIONS THAT YOU HAVE ONLY ONE QUESTION. SO THERE'S A NUMBER OF PARTS TO THIS, THE FIRST IS THAT NIH WAS DIRECTED BY CONGRESSIONAL BUDGET AUTHORIZING TO GO BACK AND WORK WITH THE COMMUNITIES THAT HAVE BEEN REALLY ADVERSELY AFFECTED BY GLOBALLY ENCOLLUSIVE DEFINITION OF CLINICAL TRIALS AND SO THERE HAS BEEN A OUTREACH MOSTLY PROFESSIONAL SOCIETY LEVELS TO IDENTIFY WHAT ARE CALLED BASIC SCIENCE STUDIES BUT I THINK ARE TO BASICALLY GET INTO THE PARADIGM OF THERE THERAPEUTIC INTERVENTION AS A CLINICAL TRIAL BUT THE FEDERAL DEFINITION OF CLINICAL TRIAL INCLUDES ESSENTIALLY ALL PROSPECTIVELY ASSIGNED TREATMENTS TO HUMANS SO A LOT BASIC SCIENCE STUFF. FROM SOFT WE NOW ARE PREPARING NEW FOAs THAT IDENTIFY A SUBSET OF CLINICAL TRIALS WHICH ARE BASIC STUDIES IN HUMAN SUBJECTS. THAT WILL BE DIFFERENT FOAs. THEY HAVE BEEN OUT FOR COMMENT. LANGUAGE IS REVIEWED BY PROFESSIONAL SOCIETIES AND FOAs ARE BEING DEVELOPED FOR PUBLICATION VERY SOON. SO THAT WILL BE FOR APPROXIMATELY -- APPLICATIONS RECEIVED STARTING IN JANUARY SO THE FISCAL YEAR. FOLLOWING FISCAL YEAR. SECONDLY, NIH HAS A POLICY TO NOT ANALYZE PEOPLE WHO USE THE WRONG FOA. IF YOU COME IN YOU ARE REVIEWED BY THOSE CRITERIA. AND THAT RELACKED ENFORCEMENT WILL CONTINUE FOR ANOTHER YEAR. MORE SPECIFIC? >> THIS WILL ALL BE RESOLVED IN A YEAR? I THOUGHT I SAW SEPTEMBER 2019 WAS DEAD LYNN FOR SOMETHING. >> THAT THE END OF THE RELAXATION -- DEADLINE FOR SOMETHING. >>S THAT THE END OF THE RELAXATION, YOU HAVE TO BE ON THE RIGHT FOA. >> I HAVE A QUESTION FOR YOU. YOU HAVE BEEN VERY HELPFUL IN ADVISING ME ABOUT THIS NIH COURSE IN PROTECTING HUMAN SUBJECTS WAS DISCONTINUED ON SEPTEMBER 26. AND JUST AS WE WERE ABOUT TO SIGN UP FOR A CITY, SAW NIH IS RESUMING THE COURSE IN PROTECTING HUMAN SUBJECTS AS OF NOVEMBER 6. BUT NOW THEY'RE GOING TO CHARGED 39.99 PER INDIVIDUAL TO TAKE THE COURSE. AND GET THIS CERTIFICATE. SO I WONDER IF YOU HAD ANY NEWS ABOUT THIS NEW COURSE AND IS IT WORTH $39, SHOULD WE GO FOR A CITY AND WHY THE MONTH HIATUS AND IT'S ALL VERY CONFUSING TO SMALL INSTITUTIONS LIKE MINE. >> I HAVE NO INCITE INTO THIS PROCESS OF DELIBERATIONS AT ALL. I WAS COMPLETELY SURPRISED BY THE APPEARANCE OF THE NEW -- I'M CO-CHAIR OF THE NIH DEVELOPMENT OF CURRICULUM FOR STAFF AND -- MY SENSE IS THAT NIH SAYS THEY THEY'RE GOING TO GIVE YOU CREDIT FOR SOMETHING THEY REQUIRE IN THEIR COURSE. SO THAT'S A STRONG ARGUMENT. >> -- IS BETTER THAN CITY WHICH IS $129 PER PERSON. >> BUT I DON'T KNOW HOW BROAD CURRICULUM IS, HOW IN DEPTH, IT'S HARD FOR ME TO MAKE A RECOMMENDATION. >> WAIT UNTIL NOVEMBER. >> SUPERFICIAL STUFF YOU GET CREDIT AND IT'S CHEAPER. BUT IN TERMS OF WHAT THE VALUE CONTENT IS, I CAN'T. >> JUST A QUICK QUESTION ABOUT EVOLUTION OF STUDY SECTIONS GERMANE TO NEI LAST YEAR OR TWO, ANTERIOR SEGMENT STUFF HAS GONE OUT OF THE STANDING STUDY SECTIONS INTO SPECIAL EMPHASIS STUDY SECTIONS. AND OBVIOUSLY FOR MANY OF US THE FAMILIAR LANDSCAPE OF ORIENTED STUDY SECTIONS CHANGED SIGNIFICANTLY, IN SOME OF THESE A LOT INVESTIGATORS DOING FOR EXAMPLE BASIC RETINAL MECHANISMS MAY FIND THEMSELVES IN A DIFFERENT POOL WITH A DIFFERENT EXPERTISE SITTING AROUND THE TABLE THAT MAY OR MAY NOT VALUE RETINAL DISEASE MECHANISMS AS MUCH AS OTHER FUNDAMENTAL NEURAL MECHANISMS. IS THERE ANY SENSE WHERE THAT'S HEADING, IS THAT SPECIAL EMPHASIS PANEL FOR SEGMENT WORK GOING TO TURN INTO STANDING STUDY SECTION? IS THERE ANY CLARIFICATION WHERE THINGS ARE GOING IN THE CSR WORLD WILL BE APPRECIATED. >> I CAN'T TALK ABOUT THE SPECIFIC STUDY SECTIONS THAT MAY APPEAR OR NOT APPEAR THE ORGANIZATION OF STUDY SECTIONS IS REALLY IMPORTANT TOPIC. WE HAVE BEEN DOING IT ON AN AD HOC BASIS. AND NOT WITH THE SYSTEMATIC APPROACH. THERE WAS A FAIRLY HIGH LEVEL GROUP THAT WAS PUT TOGETHER LED BY JOHN AND GRAHAM WILSON, WILSON COMPTON LIKE HAD FOUR INSTITUTE DIRECTORS AND A BUNCH OF PEOPLE SO A PROPOSAL IS GIVEN TO THE CSR ADVISORY COMMITTEE IN DEPT IN WHICH A SYSTEMATIC PROCESS IN WHICH CLUSTERS OF ANYWHERE FROM 10 TO 20 BROADLY RELATED SCIENTIFIC AREAS WOULD BE EXAMINED EVERY FIVE YEARS -- SO THREE OR FOUR OF THESE WOULD BE DONE EVERY YEAR AND OVER THE COURSE OF A FIVE YEAR PERIOD YOU COME UP AGAIN. SO THE -- WEIOUS REFERRAL GUIDELINES, WHERE -- AND SO THEY WOULD BE REEXAMINED BY OUTSIDE PEOPLE SORT OF REAL MER US TO LEVEL FOLKS. THIS IS A LEVEL OF ORGANIZATION AND TIME LINE THAT WE DIDN'T HAVE BEFORE. IT'S VERY MUCH ANTICIPATED THAT IT WILL EVOLVE OVER THE NEXT FEW YEARS. I'M ASSUMING IT WILL START BRINGING IN SOME ARTIFICIAL INTELLIGENCE IN CLUSTERING KINDS OF THINGS. SO THAT HAS BEEN TRIED BEFORE WITH INCOMING APPLICATIONS TO LACK AT ASSIGNMENTS AND IT HASN'T EVEN BEEN RAISED TO THE LEVEL OF DECISION SUPPORT TOOL THAT IT'S NOT LOCKING SO GOOD. NUANCES OF THE WORDS ARE CONTEXT DEPENDENT SO IT'S A LOT MORE THAN SIMPLE -- BUT THERE'S A VERY ACTIVE EFFORT ON THAT. WITH RESPECT TO THE IMMEDIATE FATE OF SOME STANDING STEPS THAT HAVE GONE ON, GROUP ORGANIZE ODD BY BRUCE REED DIVISION DIRECTOR AT CSR, WAS PUT TOGETHER LAST MONTH TO LOOK AT THAT. AND THEY MADE RECOMMENDATIONS, THOSE RECOMMENDATIONS WILL GO TO A PANEL AT CSR THAT DEFINE -- DECIDES WHAT GROUPS ARE IMPANELED. THAT NORMALLY STANDING UP A COMMITTEE YOU HAVE TO GO THROUGH FEDERAL REGISTERS JUST LIKE THIS COMMITTEE DOES, SO THAT MAY TAKE AS MUCH AS A YEAR BUT THE DECISION ABOUT WHAT WILL BE DONE AND MOVED WHAT NEW STANDING STEPS WILL BE CREATING WHAT NEW IF ANY STUDY SECTIONS WILL BE CREATED SHOULD BE BY END OF THIS CALENDAR YEAR. WITH THAT, GOING TO ASK DR. RECEIVE IF SHE WANTS GET THROWN UNDER THE BUS SHE WAS ONE OF THE MEMBERS AT THAT PANEL THAT LOOKED AT IT. >> WE HAD A ALL DAY MEETING COUPLE OF WEEKS AGO I BELIEVE. >> THE DATE OF WORKSHOP (INAUDIBLE) (OFF MIC) >> AND AT THE CONCLUSION OF THE MEETING WE WERE TOLD THAT IF MEMBER THE COMMUNITY ASKED US HOW IT WENT, WE WERE ALLOWED TO SAY CERTAIN THINGS SO I WILL SAY THOSE THINGS. THE VISION SPECIFIC STANDING, THE OCULAR SURFACE SPECIFIC STANDING STUDY SECTIONS RECOMMENDED TO BE FORMALLY ACCEPTED. , A NAME IS PROPOSED. AND THEN WE DISCUSSED BBS AND DPBS AND HOW THOSE WERE GOING. AND IDENTIFY STRENGTH IN SOME THINGS SENT TO ONE STUDY SECTION OR THE OTHER. THEN THERE WAS DISCUSSION AMONG THE RETINA CIRCUITRY PEOPLE ABOUT POTENTIALLY THE FORMATION OF A NEW STANDING SET AND HOW IT MIGHT BENEFIT THE COMMUNITY TO PUT CERTAIN TYPES OF PROJECTS INTO THAT. THOSE THINGS ARE BROUGHT TO CSR MEETING IN MARCH AND THEY WILL VOTE AND THEN A GENERAL ANNOUNCEMENT THEREAFTER. IT WAS A VERY PRODUCTIVE MEETING AND LOT OF DISCUSSION GOING ON AND YOU WILL HEAR THE FINAL REPORT AT SOME POINT. THANK YOU. >> ONE QUICK FOLLOW UP. WAS THERE ANY DISCUSSION OR HAS THERE BEEN ANY DISCUSSION OF FOR INSTANCE CVP WHICH WAS NEI STUDY SECTION AND THEN MERGE INTO SPC SOMETHING ELSE. ANY DISCUSSION OF THAT COMING BACK INTO NEI. >> NO. THERE WAS LOTS OF DISCUSSION ABOUT HOW THINGS GOT PUT INTO THOSE OTHER STUDY SECTIONS WHERE THERE ARE FEW NEI GRANTS AND MOST FUNDED BY OTHER AGENCIES. PEOPLE WANT TO BE FAIR TO EVERYBODY AND IT'S A CONTENTIOUS ISSUE AMONG PEOPLE AROUND THE TAME, THERE WAS NOT A LOT OF AGREEMENT ABOUT WHAT TYPE OF CHANGE SHOULD BE MADE. THEY CAME DOWN TO WHERE THEY WANT TO CREATE POTENTIAL SEP TO TEST OUT SOME THEORIES HOW TO IMPROVE THE WAY THINGS WERE GOING WITH THE NEW SEP. SO THAT WAS THE -- ABOUT THE WAY IT WENT. THERE WAS ISSUES THAT SOMETHING WASN'T PASS GOOD AS THEY WOULD LIKE BUT THEY WEREN'T REALLY SURE EXACTLY THE BEST WAY TO MAKE CHANGES TO IMPROVE THINGS. >> SO THE PREVIOUS EFFORTS THAT USED THE WROTE CONTROL PROPOSED TO THE CSR ADVISORY COMMITTEE STANDING, HAVE RESULTED IN SOMETHING LIKE THAT LITTLE BIT LESS THAN 10% GRANTS GETTING REASSIGNED. SO THIS IS NOT AT MARGIN BUT INTENT IS TO PRESERVE CONTINUITY FOR AS MUCH AS POSSIBLE. IT'S IN EVERYBODY'S INTEREST ESPECIALLY BEST SERVES THE SCIENCE. THERE IS A CLEAR THOUGHT THAT EVERYTHING HAS TO BE REEXAMINED DEEPLY AND REGULARLY AND SO SOME BIT OF CHANGE IS GOING TO BE FACT OF LIFE WHERE YOU JUST WANT TO MAKE IT A LITTLE MORE TRANSPARENT. >> PROCESS IS INTERESTING. >> GOOD.