WELCOME TO THE 154TH MEETING OF THE NATIONAL ADVISORY EYE COUNCIL. THANKS TO ALL THOSE PRESENT. ESPECIALLY OUR COUNCIL MEMBERS, OUR GUEST SPEAKER AARON LEE, NEI STAFF, OTHER NIH STAFF INCLUDING PEOPLE FROM THE CENTER FOR SCIENTIFIC REVIEW. AND THE IRG FROM CSR. ANY ADVOCATES FROM VISION RESEARCH WE MIGHT HAVE IN THE AUDIENCE INCLUDING MEMBERS OF ARVO AND NEIGHBOR. ANY MEMBERS OF THE OPHTHALMOLOGY AND OPTOMETRY ASSOCIATIONS WHO MIGHT BE PRESENT AND MEMBERS OF THE PUBLIC. I ALSO INCLUDE A WELCOME TO ALL THOSE WHO MIGHT BE WATCHING THIS VIDEOCAST OF OUR OPEN SESSION. I WILL MENTION WE HAVE ONE COUNCIL MEMBER WHO IS COMING IN BY PHONE AND THAT'S RUSS VAN GELDER. THIS IS A VERY UNUSUAL CIRCUMSTANCE. SO WE WANT OUR COUNCIL MEMBERS TO BE HERE PRESENT BUT RUSS WAS RECENTLY APPOINT TO THE COUNCIL OF COUNCILS AND THEY HAVE THEIR FIRST MEETING NEXT FRIDAY. SO HE'S ALSO TRAVELING FROM THE WEST COAST SO AS YOU KNOW, WHEN YOU TRAVEL WEST TO EAST YOU GIVE UP TWO DAYS OUT OF YOUR WEEK SO I DIDN'T FEEL LIKE HE SHOULD HAVE TO DO THAT TWO WEEKS IN A ROW. SO WE'RE LETTING HIM AS A VERY SPECIAL CIRCUMSTANCE TO COME IN BY PHONE. >> GREAT. THANK YOU, I APPRECIATE THE VARIANCE FROM USUAL POLICY, GLAD TO BE HERE AT LEAST REMOTELY. >> SINCE THE SEGMENT OF OUR COUNCIL MEETING IS BEING VID OWE CAST, PLEASE REMEMBER TO USE YOUR MICROPHONES WHEN YOU SPEAK, AND THEN TURN IT OFF AFTERWARDS SO IT WON'T INTERFERE WITH ANOTHER SPEAKER. WHEN I WAS WRITING THE OCTOBER MINUTES, THERE WERE SEVERAL COUNCIL MEMBERS WHO ASKED QUESTIONS OF EARL SMITH BUT THEY DIDN'T TURN ON THEIR MICROPHONE AND SPEAK INTO THE MICROPHONE SO I HAD TO CALL HIM SAND SAY DO YOU REMEMBER WHAT THE QUESTION WAS? AND HE DID SO I WAS ABLE TO INCORPORATE THOSE INTO THE MINUTES SO REMEMBER TO SPEAK INTO THE MICROPHONE. ALSO IN ORDER FOR RUSS TO HEAR ANY COMMENTS YOU'LL HAVE TO DO THAT. SO HOUSE KEEP KEG TAILS I ALWAYS GO THROUGH, EACH OF YOU, COUNCIL MEMBERS HAS A FOLDER IN FRONT OF YOU THERE ARE COPIES OF THE OPEN AND CLOSE SESSION AGENDAS AND THERE'S TWO CONFLICT FORMS AND OTHER MATERIAL. SO WITH RESPECT TO THE CONFLICT FORMS WE ALWAYS PUT THEM ON ANOTHER COLOR SO YOU CAN FIND THEM EASILY, THIS TIME ON GREEN SHEETS. THESE FORMS APPLY TO CLOSED SESSION DISCUSSIONS. ONE FORM SAYS YOU WILL NOT ENGAGE IN DISCUSSION OF AN APPLICATION WHERE YOU HAVE A CONFLICT OF INTEREST. AND THE OTHER SAYS YOU DID NOT. SO YOU CAN SIGN THE WILL NOT, YOU SHOULD SIGN THAT P BEFORE THE CLOSED SESSION AND GET THAT BACK TO OUR ASSISTANT WHO IS LA TIFA HILL. SHE SENT AN EMAIL AND INTRODUCED HERSELF, SHE'S WONDERFUL RIGHT ON TOP OF THINGS. AFTER THE CLOSED SESSION YOU CAN SIGN DID NOT FORM AND MAKE SURE SHE GETS THAT AS WELL. WE ARE LUCKY THIS TIME, THERE ARE NO CONFLICTS FOR THE CLOSED SESSION SO THAT SHOULD WORK WELL. LATIFA HAS MOST OF YOUR LUNCH MENUS. IF YOU DIDN'T GIVE HER ONE, THERE MAY BE ONE IN YOUR FOLDER. SHE HAS SOME EXTRA COPIES SO JUST MAKE SURE YOU MAKE A LUNCHEON CHOICE AND GET TO HER EITHER $10 OR A CREDIT CARD AND SHE WILL TAKE CARE OF THE REST. SO WE'RE GOING TO HAVE THESE LUNCHES LIKE WE HAD -- WE HAVE DONE THE LAST TWO TIMES, WE WILL HAVE THEM DELIVERED UPSTAIRS TO THE THIRD FLOOR TO OUR CONFERENCE ROOM SO WHEN WE BREAK FOR LUNCH GO UP THERE SUITE 3400 AND YOU WILL BE ABLE TO GET INTO OUR SUITE AND HAVE LUNCH IN THE CONFERENCE ROOM. SO WITH THOSE ITEMS OUT OF THE WAY I'M GOING TO TURN IT BACK OVER TO DR. TUMMINIA AND SHE WILL SPEAK TO YOU ABOUT INTERESTING THINGS. >> THANKS, ANNIE. I WOULD LIKE TO ADD MY WELCOME TO THOSE IN THE ROOM AND DR. VAN GERDER IN THE ROOM AND STAKE HOLDERS WATCHING ON THE VIDEOCAST. I WON'T DO ANY OF THE HOUSEKEEPING SINCE ANNIE DID THAT, SO WE'LL GET RIGHT TO BUSINESS. FOR COUNCIL MEMBERS WE DON'T HAVE ANY UPDATES ON OUR NEW COUNCIL SLATE. BUT WE DO HAVE FOUR MEMBERS WHO ARE ROTATING OFF AND I WOULD LIKE TO ADD MY THANKS TO TOM GLAZER. DENNIS LEVI, SUSAN SMITH AND LEWIS DOING EXTRA SERVICE ON COUNCIL. THEY WILL BE TECHNICALLY ON COUNCIL UNTIL MAY BUT THIS IS ACTUALLY THEIR LAST PHYSICAL IN PERSON COUNCIL SESSION SO I WOLD LIKE TO THANK YOU FOR YOUR SERVICE AND ADD MY THANKS WITH THE SECRETARY FOR WHICH YOU HAVE ALL RECEIVED CERTIFICATES SO THANK YOU. CAN WE FIEF THEM A ROUND OF APPLAUSE? GIVE THEM A ROUND OF APPLAUSE? IF YOU DON'T WANT TO TRAVEL WITH YOUR FRAMED PLAQUE, YOU CAN GIVE IT TO ME AND I CAN FEDEX IT TO YOU. >> SO I FIELD AD FEW QUESTIONS THIS MORNING ABOUT THE SEARCH FOR THE NEI DIRECTOR SO I CAN GIVE YOU A SMALL UPDATE WHICH IS NOT TOO INFORMATIVE BUT AT LEAST YOU KNOW WHERE EVERYTHING STANDS. AS EVERYONE HERE NOSE DR. SEEVING STEPPED DOWN AS DIRECTOR OF THE NATIONAL EYE INSTITUTE IN JULY AND A SEARCH WAS INSTITUTED AND NOVEMBER. THE SEARCH CLOSED DECEMBER 2ND. CURRENTLY THERE IS A SEARCH COMMITTEE AND APPLICANTS ARE BEING REVIEWED. IT'S HARD TO PUT A TIME LINE ON THESE SEARCHES BECAUSE AFTER THERE IS THE REVIEW, THERE IS AN INTENSE INTERVIEW PERIOD AND HEN THE TOP CANDIDATES ALSO GOES THROUGH FINANCIAL AND ETHICS CLEARANCE FOR TYPES OF HOLDINGS DIE VESTITURES THEY HAVE TO DO IF THEY COME INTO THIS POSITION SO IT'S HARD TO CALL -- DEFINE WHAT THE TIME LINE MIGHT BE. THE OTHER THING I WOULD LIKE TO KEEP IN MIND IS NIH IS CURRENTLY HOLDING FIFED DIRECTOR SEARCHES FOR DIFFERENT INSTITUTES AND ALL SITTING DIRECTORS SERVE AS CHAIRS OF THE THOSE COMMITTEES. SO IT'S A CHALLENGING TIME FOR SENIOR HR DEPARTMENT IN THIS AREA. BEAR WITH US AS WE WORK THROUGH THE NIH HIRING PROCESS. BECAUSE WE DON'T HAVE A PERMANENT DIRECTOR SEARCH FOR SCIENTIFIC DIRECTOR IS STILL ON HOLD. THAT'S SO WE CAN DO A SEARCH FOR A SCIENTIFIC DIRECTOR FOR INTRAMURAL PROGRAM THAT ALIGNS WITH RESEARCH INTEREST OF THE NEW INCOMING DIRECTOR. FOR NOW THAT'S STILL ON HOLD AND DAVID IS STILL ACTING SCIENTIFIC DIRECTOR UNTIL SUCH TIME AS WE INSTITUTE A NEW SEARCH. GOOD NEWS FRONT FOR HIRES WE ARE LOOKING FOR DIRECTOR OF EXTRAMURAL ACTIVITIES WHICH DR. SCHAFFNER IS SO ABLY ACTING. WE ARE ACTUALLY DOING THE INTERVIEWS AS WE SPEAK AND WE HOPE WE WILL BE ABLE TO MAKE AN ANNOUNCEMENT SOMETIME WITHIN THE NEXT COUPLE OF MONTHS. WE HAVE A FABULOUS POOL OF CANNED DATES. SOME WITH QUITE A LOT OF EXPERIENCE IN THIS AREA SO I FEEL WHOEVER WE GET WILL DO A GOOD JOB. THAT BEING SAID I WOULD LIKE TO THANK ANNIE FOR HER CONTINUED GOOD WORKS IN THIS CAPACITY. [APPLAUSE] SO WE HAVE NEW STAFF ADDITIONS THAT I WOULD LIKE TO SHARE WITH YOU AS MANY OF YOU ALREADY INTERACTING WITH SOME THEM OVER TIME. FIRST DIVISION OF EXTRAMURAL SCIENCE PROGRAMS WE HAD JAMES GALL. JAMES IS A Ph.D. WHO RECENTLY JOINED DSP AS PROGRAM ANALYST, PRIOR TO COMING TO NEI HE WAS SCIENTIFIC REVIEWER AT THE DIVISION OF MOLECULAR GENETICS AND PATHOLOGY AT THE FDA. HE HAS AN INTERDISCIPLINARY BACKGROUND WITH STRONG EMPHASIS ON BIOINFORMATICS AND GENOMICS DATA ANALYSIS. WITH ALL THE NEW DATA PROJECTS AND NEW INTEREST IN NIH DATA ACTIVITIES THIS IS A REALLY IMPORTANT AREA FOR US TO HAVE EXPERTISE IN. HE PREVIOUSLY WORKED AT NEI AS CONTRACTOR FROM 2001 TO 2008 PROVIDING DATABASE ADMINISTRATION AND PROGRAMMING FOR GENOMICS PROJECT AND MOLECULAR STRUCTURE AND GENOMICS SECTION OF THE INTRAMURAL PROGRAM. WELCOME TO JAMES. WE ALSO HAVE DR. SONG IN THE DIVISION OF EXTRAMURAL SCIENCE PROGRAMS, M.D. Ph.D. AND SHE'S ALSO A PROGRAM ANALYST. SHE COMES TO US MOST RECENTLY AS A POST-DOCTORAL FELLOW IN DR. SEIVING'S LAB IN THE SECTION OF TRANSLATIONAL RESEARCH AND RETINAL MOLECULAR DEGENERATION OVER AT NIDCD, THE DEAFNESS INSTITUTE. SHE EARNED Ph.D. IN BIOCHEMISTRY AND MOLECULAR BIOLOGY FROM SCHOOL OF MEDICINE AND M.D.ED FROM UNIVERSITY SCHOOL OF MEDICINE IN CHINA. IN THE DIVISION OF EXTRAMURAL ACTIVITIES YOU RECEIVED A LETTER OF INTRODUCTION FROM LATIFA SO LATIFA HILLS JOINS US THIS PAST YEAR AS PROGRAM SPECIALIST PRIOR TO COMING TO NEI SHE HAD AD MINUTE INVESTIGATIVE ROLE AT THE CLINICAL CENTERS DEPARTMENT OF TRANSFUSION MEDICINE. SHE WILL BE UNDERTAKING COUNCIL DUTIES SO YOU WILL BE HEARING FROM HER A LOT. SHE SUPPORTS US ALSO IN OTHER ACTIVITIES SUCH AS TRAVEL. MAKE HER YOUR FRIEND. IN THE NEW OFFICE OF REGENERATIVE MEDICINE WE HAVE AMBER LYNN REED, A PROGRAM SPECIALIST, SHE HAS BS DEGREES IN PUBLIC HEALTH AND SOCIAL PSYCHOLOGY AND IS WORKING ON HER MASTERS DEGREE IN PUBLIC HEALTH. PRIOR TO JOINING NEI SHE WORKED AS A DISEASE INTERVENTION SPECIALIST IN THE DEPARTMENT OF DEFENSE AND AS PUBLIC HEALTH TECHNICIAN IN THE US AIR FORCE. SO WELCOME AMBER. WE HAVE COUPLE OF AWARDS OR ACCOLADES THAT I WOULD LIKE TO SHARE WITH YOU FROM OUR INTRAMURAL PROGRAM. WE HAVE A TENURE TRACK INVESTIGATOR, WHO IS NAME AD 2019 DISTINGUISHED SCHOLAR. THIS IS A COHORT MODEL FOR ENHANCING DIVERSITY AND INCLUSION OF PRINCIPLE INVESTIGATORS AND INTRAMURAL RESEARCH PROGRAM. THIS IS A RELATIVELY NEW PROGRAM. OUR THIRD DISTINGUISHED SCHOLAR JOINING DR. CATHY AND DR. SAND IN THIS PROGRAM, AND I WILL SAY MORE ABOUT THAT LATER. THIS PROGRAM PROVIDES INVESTIGATORS WITH FUNDING SUPPORT AS WELL AS OTHER RESOURCES, MENTORING AND PROFESSIONAL DEVELOPMENT ACTIVITIES AND WE ARE FINDING IT'S AN EXCELLENT PROGRAM TO FOSTER AMONG YOUNGER INVESTIGATORS. SELECTION FOR THIS PROGRAM IS EXTREMELY COMPETITIVE AND IT'S PRESTIGIOUS RECOGNITION OF THEIR OUTSTANDING ACCOMPLISH. S NOT ONLY IN SCIENCE BUT IN THEIR EFFORTS ALONG THEIR CAREER TRAJECTORY HAVE ALREADY SHOWN IN THE AREAS OF DIVERSITY AND INCLUSION. SO IT TIES ALL THOSE THINGS TOGETHER. QUITE A NICE PROGRAM ALSO HELPING NIH IMPROVE THEIR DIVERSITY AND INCLUSION ACTIVITIES. NEXT I WOULD LIKE TO CONGRATULATE DR. BARTI IN EXTRAMURAL RESEARCH WHO LAUNCHED AID PROVE TO LAUNCH THE FIRST CLINICAL TRIAL OF PATIENT DERIVED IPS CELL THERAPIES TO REPLACE AND REPAIR DYING CELLS IN THE RETINA TO TEST AGAINST INDIVIDUALS THAT HAVE GEOGRAPHIC ATROPHY. WE ARE EXCITED ABOUT THIS. CURRENTLY THE PROTOCOL IS GOING TO IRB AND WE HOPE TO INJECT THE FIRST PATIENT SOMETIME THIS SUMMER SO WE'LL KEEP YOU POSTED. DR. BARDI IS HERE, IF YOU ARE INTERESTED IN HIS PROTOCOL FEEL FREE TO ASK HIM DURING THE BREAK. HE'S HAPPY TO SHARE. BEFORE WE GET TO THE AGENDA, I WOULD LIKE TO GO OVER SOME THINGS THAT ARE GOING ON AT NIH SO THIS -- IN THE PAST FEW MONTHS WE HAVE HAD BOTH NIH LEADERSHIP FORUM WHICH IS SORT OF A RETREAT FOR THE NIH DIRECTORS WHERE WE TALK ABOUT SCIENCE ISSUES AND WE TALK ABOUT LARGER ISSUES AT NIH. ALSO IN DECEMBER DR. COLLINS HAD HIS MEETING OF HIS ADVISORY COUNCIL TO THE DIRECTOR AND THERE WERE SOME CROSS OVERLAP OF TOPPINGS AT BOTH MEETINGS. A FEW TOPICS ONE WAS THE HEEL INITIATIVE WHICH ADDRESSES THE OPIOID ADDICTION. THAT'S HEEL STANDS FOR HOPING TO END ADDICTION LONG TERM. THERE'S ALSO ENHANCING REPRODUCIBILITY AND RIGOR IN ANIMAL RESEARCH, DIVERSITY WAS BIG AS WELL AS HOW TO SUPPORT NEXT GENERATION RESEARCHERS, CHANGING THE CULTURE TO END SEXUAL HARASSMENT, ARTIFICIAL INTELLIGENCE. FOREIGN INFLUENCE AND THE NEW NIH STRATEGIC PLAN. I'M NOT GOING TO GO OVER ALL THOSE TOPICS WITH YOU OBVIOUSLY BUT IF YOU ARE INTERESTED ON THE NIH ACD WEBSITE, THERE ARE ALL OF THE PRESENTATIONS THERE AND SOME OF THEIR QUITE WELL DONE AND ENCOURAGE YOU TO LOOK AT THEM ESPECIALLY IF YOU HAVE AN INTEREST IN DIVERSITY, SEXUAL HARASSMENT SOME OF THE THINGS THAT NIH IS DOING, WE DID A CLIMATE SURVEY AND WE ALL HAVE A RESULTS TO SHOW WHERE WE CAN IMPROVE SOME OTHER ORGANIZATIONS ARE ASKING US TO USE THE SAME SURVEY INSTRUMENT AND SO NIH IS GOING TO MAKE THAT AVAILABLE TO OTHER ORGANIZATIONS. BUT THERE ARE ALSO RECOMMENDATIONS FROM THE ACD WHICH ARE INTERESTING. SOME OF THOSE RECOMMENDATIONS WOULD LIKE TO TAKE ATE STEP FURTHER THAN WHAT I THINK NIH'S PURVIEW IS. THEY MAKE FOR PROVOCATIVE READING SO ENCOURAGE YOU TO LOOK AT THOSE SLIDE SETS. FOR DIVERSITY, I'LL GET BACK TO THAT DISTINGUISHED SCHOLARS PROGRAM. THEY LOOKED WHETHER OR NOT WE CAN JUDGE OVER JUST EVEN THE LAST TWO YEARS HOW SUCCESSFUL THAT PROGRAM IS, AND ONE THING THEY FOUND IS THAT THE SCHOLARS THEMSELVES WHEN THEY ARE SURVEYED FOUND THAT THE MENTORING PART AND THE OPPORTUNITIES FOR NETWORKING ARE THE MOST CRITICAL ASPECTS OF THAT PROGRAM. EVERYBODY LOVES GETTING THE RESOURCES AND THAT KIND OF SUPPORT. BUT THE THEY WAY SET UP MENTORING ACTIVITIES IS A TEAM OF MENTORS. SO YOU CAN HAVE TEN OR 12 MENTORS AND THEY CAN EACH FILL A CERTAIN NICHE OF WHAT YOU FEEL IS IMPORTANT TO YOUR CAREER. AND THEY THINK THIS IS REALLY VALUABLE SO THIS IS SOMETHING THAT'S VERY EXCITING FOR NIH. THERE'S DEFINITELY COMMITMENT THE SUPPORT IS GUARANTEED FOR FIVE YEARS AND THERE'S A LITTLE BIT OF HINTING, IT COULD GO AS LONG AS SEVEN WHICH TAKES MOST TO TENURE TRACK REVIEW. RIGHT NOW WE ARE BANKING ON FIVE YEAR SUPPORT BUT IT'S TURNED OUT TO BE HELPFUL TO THOSE SCHOLARS AND THEY DEFINITELY FEEL SUPPORTIVE AND THEY NOT ONLY HAVE THEIR MENTORS BUT THEY HAVE EACH OTHER. THERE ARE MANY OPPORTUNITIES FOR THEM TO GET TOGETHER AND EXCHANGED STORIES. WE ARE PLEASED WITH HOW THAT PROGRAM IS BEING LAUNCHED AND MANAGED. ATTAR OFFICIAL INTELLIGENCE AND DATA MANAGEMENT SO HE WILL BE TELLING US SOME OF THE THINGS GOING ON IN ARTIFICIAL INTELLIGENCE. BUT ARTIFICIAL INTELLIGENCE, MACHINE LEARNING, DATA MANAGEMENT BIG TOPICS FOR NIH THAT WE ARE SUGGESTION STRUGGLING WITH,S RETROSPECTIVE DATA, THE WORKING GROUP ADVISORY COUNCIL TO THE DIRECTOR CAME UP WITH SOME RECOMMENDATIONS. THOSE WHO HAVE LONG STANDING DATA SETS THAT WERE COLLECTED YEARS AGO WOULDN'T NECESSARILY LIKE THE RECOMMENDATIONS OF THE ADVISORY COUNCIL, THROW IT ALL AWAY AND START FRESH AND THINK ABOUT MACHINE LEARNING AND HOW MACHINE LEARNING WILL HELP YOU LOOK AT YOUR DATA. OBVIOUSLY KNOW ONE IS THROWING AWAY DATA SETS BUT LESSONS THERE WE HAVE TO BE MINDFUL WHAT WE ARE TRYING TO FIND FROM THAT DATA, WHAT WE ARE ASKING ASSUMPTIONS THAT WE ARE MAKING THAT MAY NOT BE ACCURATE AS WE GO THROUGH EACH ITERATION OF MACHINE LEARNING. THERE'S SOME CAUTIONS THERE BUT A LOT OF RECOMMENDATIONS SO I THINK THAT'S REALLY IMPORTANT FOR YOU TO LOOK AT. BECAUSE THOSE ARE SOME OF THE THINGS WE WILL BE TACKLING BOTH NIH PROPER AND WITHIN THE NEI ITSELF. ONE OF THE OTHER THINGS NIH IS DOING IS PILOTING SOME PROJECTS IN MACHINE LEARNING, ONE IS SPECIFIC DIGITAL FELLOWSHIP AND THERE'S ALSO GRADUATE DATA SCIENCE PROGRAM. MACHINE LEARNING IS A MAJOR FOCUS OF THOSE PROGRAMS. AND WHAT THEY ARE IS AT LEAST FOR THE CIVIC DIGITAL FELLOWSHIP, IT'S TAKING STUDENTS WHO HAVE EXPERTISE IN COMPUTER SCIENCE WHO HAVE NO EXPERTISE IN BIOMEDICAL SCIENCE, AND PUTTING THEM IN AT NIH TO WORK ON REAL TIME PROBLEMS TO SHOW THEM WHAT THEY CAN CONTRIBUTE TO THIS FIELD. AND ACTUALLY THE FIRST YEAR THERE WERE 10 FELLOWS IN THE DIGITAL FOLLOW SHIP PROGRAM, HAPPY TO SAY NEI HAD ONE OF THOSE FELLOWS. SHE WAS FABULOUS AND SHE'S ACTUALLY BEING TOUTED AS ONE OF THE SUCCESSES FROM THAT CIVIC DIGITAL PROGRAM, WE GIVE HER A PROJECT SHE WORKED ON AND SHE WAS ABLE TO HELP US SCRAPE DATA AND FIND MISSING DATA THAT WAS REALLY IMPORTANT FOR DATA ANALYSIS. NIH IS VERY SERIOUS ABOUT TRYING TO MELD COMPUTER SCIENCES WITH THE BIOLOGICAL SCIENCES, AND SO THIS IS ALSO SOMETHING THAT WE WOULD LIKE TO TAKE A LEADERSHIP ROLE IN. LIKE YOU TO PAY ATTENTION TO SOME OF THE CONVERSATION ON FOREIGN INFLUENCES. NIH IS TAKING THIS SERIOUSLY. WE ARE ALSO WORKING WITH GOVERNMENT AGENCIES, WHERE THERE ARE INSTANCES OF FOREIGN INFLUENCE DISCOVERED AND WE ARE WORKING CLOSE WITH INSTITUTIONS WHERE SUCH VIOLATIONS OF FOREIGN INFLUENCE HAVE BEEN IDENTIFIED. THIS IS SERIOUS. NIH IS TAKING THIS SERIOUSLY AND SO IS THE GOVERNMENT. I WOULD STAY TUNED FOR SOME THINGS WE ARE DOING, LOOK AT THE SLIDES AND THE RECOMMENDATIONS FROM THE WORKING GROUP WHERE WE ARE HEADED WHAT WE ARE DOING AND HOW WE ENCOURAGE INSTITUTIONS AND ACADEMIC PARTNERS TO HELP WITH THAT ANALYSIS. NIH HAD SUCCESS WITH ACADEMIC INSTITUTIONS COMING FORWARD HAVING IDENTIFIED THEIR OWN AREAS OF FOREIGN INFLUENCE. WE ARE WORKING WITH THEM TO HELP ADDRESS SOME OF THOSE PROBLEMS. WE DID ALSO TALK ABOUT SCIENCE AT THE LEADERHIP, BUY LOGICAL SCIENCE BUT I CAN'T SHARE WITH THAT IS YET BECAUSE IT IS NOT FULLY DEVELOPED EXCEPT TELL YOU NEI WILL BE INVOLVED IN THAT WILL IS A FRANCE NIH WORKING GROUP THE GEROSCIENCE WORKING GROUP, THAT MIGHT GIVE YOU HINTS. NOTHING IS WORKED OUT BUT THERE WILL BE A STRONG PUSH SO WE MIGHT BE SEEING SOMETHING MORE COMING FROM THAT OVER THE NEXT COMING MONTHS. WHAT YEAR IS THIS? 2020. WE WOULD BE VERY REMISS IF WE DIDN'T TAKE ADVANTAGE OF THE FACT THAT IT IS 2020. WE DO HAVE A CAMPAIGN FOR ACTIVITIES AND YOU MIGHT BE HEARING FROM MARIA ZAKARIAS AND TEAM OFFICE OF COMMUNICATIONS, WE ARE PARTNERING WITH OUR STAKEHOLDER ORGANIZATIONS LIKE ARVO AND WE ARE WORKING TOWARDS ACTIVITIES, WE HAVE VIDEO SERIES, EDUCATIONAL PROGRAMS, SOCIAL MEDIA CAMPAIGNS AND WE ARE WORKING WITH NATIONAL EYE HEALTH EDUCATION PROGRAM AND INVIGORATING THAT AND PUTTING 2020 ACTIVITIES INTO THAT AS WELL. WE ARE WORKING ON 2020 ACTIVITIES AND I ENCOURAGE YOU, IF YOU HAVE ANY IDEAS FEEL FREE TO EMAIL MARIA AND LET HER KNOW WHAT THEY ARE AND WE RECOLLECT WHO WORK WITH YOU TO GET NEWS OUT THERE. WE WANT TO EDUCATE THE PUBLIC ABOUT VISION HEALTH AND HOW TO TAKE CARE OF THEIR EYES. THAT'S WHAT THE GOAL OF THIS TO 2020 IS. CAMPAIGN TITLE IS MORE THAN MEETS THE EYE. TO THE AGENDA, I'M NOT GOING TO STEEL THUNDER OF FOLKS TALKING BUT WE WILL HAVE KAREN COLBERT WHO IS OUR BUDGET OFFICER GIVE YOU THE BUDGET UPDATE AND WE HAVE SOME GOOD NEWS FOR NIH AND N EI. I WILL LET HER TELL YOU WHAT IT IS. YOU WILL GET AN UPDATE FROM DR. GORDON ON THE STRATEGIC PLAN. OUR RFI CLOSED ON JANUARY 9 FOR THE STRATEGIC PLAN FOR THE WHERE WE REQUESTED INFORMATION FROM THE COMMUNITY. I WILL SAY FOR NEI WE HAD A VERY SUCCESSFUL RESPONSE. YES EXCITED BY RESPONSES WE RECEIVED. STEVE BECKER WILL UPDATE YOU ON OFFICE OF REGENERATIVE MEDICINE NOT ONLY ON HOW HE IS INTERACTING WITH THE VARIOUS PARTS OF THE INSTITUTE BUT ALSO ON SEVERAL NEW INITIATIVES THAT WE ARE UNDERTAKING. WE WILL HEAR FROM DR. BRUCE REED CSR WHO WILL DISCUSS THE INQUIRE PROCESS. AND WE WILL ALSO HEAR FROM DR. JERRY WUJEK WHO WILL DISCUSS SBIR STTR PORTFOLIO AND DR. AARON LEE WHO WILL -- IS COMING FROM THE UNIVERSITY OF WASHINGTON AND HE WILL BE PRESENTING ON AI AND DEEP LEARNING APPLICATIONS AND OPHTHALMOLOGY AND VISION SCIENCE. WITH THAT, I WILL ASK DR. KAREN COLBERT TO COME TO THE PODIUM. >> ADMINISTRATIVE DETAILS. JUST A FEW. SO ONE WOULD BE THE OCTOBER MINUTES. ANY DIRECTIONS OR CHANGES THAT NEED TO BE MADE? IF NOT, I NEED A MOTION TO APPROVE THOSE. AS WRITTEN. ALL IN FAVOR, ANY OBJECTIONS? IF YOU RECALL IN JUNE I PRESENT AD SPREADSHEET OF THE PARs AND RFAs THAT EITHER THE NEI SPONSORS OR PARTICIPATES IN. THE NIH THOSE BE BROUGHT TO OPEN SESSION. AND VETTED. SO THE WAY TO HANDLE THAT GOING FORWARD WOULD BE EVERY COUNCIL ROUND I WOULD UPDATE THAT SPREADSHEET. AND LET YOU KNOW WHICH PARs OR RFAs ARE GOING TO BE REISSUED. SO THE POINT IS YOU WILL HAVE HEARD ABOUT THEM INITIALLY AND THESE ARE JUST THE REISSUE. SO I DON'T THINK WE HAVE TO GO THROUGH ANOTHER VETTING SESSION. BECAUSE YOU WILL HAVE SEEN THEM. SO I WILL MAKE A NOTE OPT SPREADSHEET, WE WILL CONTINUE OF COURSE TO BRING FOR CONCEPT CLEARANCE ANY NEW RFA OR PAR. IF THAT IS FINE WITH COUNCIL MEMBERS, I WOULD LIKE TO PROCEED THAT WAY. THE THIRD ISSUE IS WAS I WOULD LIKE TO MAKE A CHANGE TO OUR COUNCIL OPERATING PROCEDURES. I WILL GO HERE TO SHOW A COUPLE OF SLIDES. SO IN THE PAST, WE ALWAYS BROUGHT CONCERNS THAT WERE RAISED DURING PEER REVIEW TO THE COUNCIL DURING THE CLOSED SESSION. THAT WOULD HAVE BEEN CONCERNS WITH HUMAN SUBJECTS PROTECTIONS, INCLUSION, BIOHAZARD, SELECT AGENTS, VERTEBRATE ANIMALS. THE NIH HAS ALREADY DETERMINED HEADACHE NOT BE RESPONSIBLE FOR HUMAN SUBJECTS PROTECTIONS. THAT'S THE INSTITUTIONAL IRB THAT HANDLES THOSE. SO WE HAVE ALREADY MADE A DECISION THERE WAS A CHANGE IN OUR OPERATING PROCEDURE. TO HANDLE BIOHAZARDS INTERNALLY. WHAT I WOULD LIKE TO ASK COUNCIL IS IF WE COULD BRING HANDLE ALL THESE ISSUES INTERNALLY, PROGRAM STAFF, WOULD WORK WITH PI, THE INSTITUTIONAL IRB, THIS WOULD MAKE IT WE WOULD BE ABLE TO SAVE TIME IN CLOSED SESSION AND PREVENT OVERLAP OF EFFORT. WHAT WE CONTINUE TO BRING TO YOU IS UNRESOLVED CONCERNS OR IF WE WANTED YOUR INPUT ON A PARTICULAR ISSUE. I CHANGE THE STATEMENT IN COUNCIL OPERATOR PROCEDURES TO SAY THAT NEI STAFF WILL HANDLE ANY OF THESE CONCERNS. WE ALREADY FOR VERTEBRATE ANIMALS STAFF ALREADY WORKED WITH THE PI THROUGH THE OFFICE OF ANIMAL LABORATORY WELFARE. SO WE DON'T BRING THOSE TO YOU ANY MORE. JUST KNOW THE NEI WOULD NEVER FUND AN APPLICATION THAT HAD ANY UNRESOLVED ISSUES OR CONCERNS. THEN OF COURSE WHAT WON'T CHANGE IS THAT THERE ARE THINGS WE ALWAYS BRING TO COUNCIL. IF SOMETHING IS A PHASE 3 CLINICAL TRIAL WITHIN THE FUNDING RANGE THE FOREIGN APPLICATIONS, IF THERE'S EVER A QUESTION ABOUT THE ADEQUACY OF A REVIEW, IF THERE IS A GRIEVANCE OR APPEAL, AND THEN THE SPECIAL COUNCIL REVIEW, THOSE ARE PIs THAT IF THEY ARE FUNDING THIS ROUND WILL HAVE MORE THAN A MILLION DOLLARS IN DIRECT FUNDS. THOSE WE WILL ALWAYS CONTINUE TO BRING BEFORE COUNCIL. SO WHAT I WOULD LIKE WOULD BE IF YOU FEEL THAT THIS IS ADEQUATE I WOULD LIKE A MOTION TO APPROVE THIS CHANGE TO OUR OPERATING PROCEDURES. ABSOLUTELY. >> YOU KNOW WHAT, I'M THINKING IS NUMBER ONE, IS THERE SOME STATUTORY OBLIGATION THE COUNCIL HAS TO REVIEW HUMAN SUBJECTS CONCERNS, IS THIS SOMETHING THAT IT'S JUST BEEN THE PREROGATIVE OF THE NEI STAFF TO BRING ISSUES TO OUR ATTENTION S. >> THERE IS GUIDELINES COUNCIL SHOULD BUT HAZEN BEEN CHANGED EVEN SINCE THE LAST YEAR AND A HALF AGO WHEN IT WAS DETERMINED THAT THE NIH CAN'T BE THE FINAL SAY ON THAT, IT'S THE INSTITUTIONAL IRB. THOSE POLICIES HAVEN'T BEEN UPDATED. >> IF YOU CAN CHECK BECAUSE WE CAN'T ABROGATE OUR OWN RESPONSIBILITY. THE SECOND THING THAT OCCURS TO ME, HUMAN SUBJECT CONCERNS ARE SOMETHING MIGHT BE BEST DEALT WITH BY ACTIVE CLINICIANS. ARE THERE ACTIVE CLINICIANS THAT STAFF OF NEI THAT ARE ENGAGED IN MAKING DETERMINATION THAT SOMETHING DOES OR DOES NOT NEED TO BE BROUGHT -- >> IF THIS WERE A CLINICAL TRIAL, WE WOULD DEFINITELIBLY THAT BEFORE YOU. >> THAT'S A HUMAN SUBJECT CONCERN. THAT'S NOT CONSISTENT WITH WHAT YOU JUST WROTE. THAT WOULD MEAN ALL HUMAN SUBJECTS CONCERNS -- >> YOU HAVE TO REMEMBER THAT NOW WITH THE DEFINITION THE WAY THE NIH DEFINES A CLINICAL TRIAL THERE ARE COMPUTER STUDIES AND BIOBEHAVIORAL STUDIES WHERE THERE WOULD BE A CONCERN. I THINK WE -- THAT STAFF COULD DEAL WITH. >> IF YOU ARE DOING SOMETHING TO A PATIENT THAT IS SOMETHING A DOCTOR NEED, A PRACTICING CLINICIAN. >> I WOULD CONSIDER THAT, IF YOU WANT I CAN INCLUDE THE -- ANY PHASE 1, 2 OR 3 CLINICAL TRIAL WE WOULD BRING THAT BEFORE COUNCIL. SO I CAN CHANGE THE FIRST BULLET. >> RETROSPECTIVE -- YOU CAN SAY IT THAT WAY, BUT I WOULD RATHER SAY ANY TRIAL THAT INVOLVES DOING SOMETHING TO A HUMAN BEING, SHOULD BE BROUGHT -- IN OTHER WORDS PHASE 1 GETS INTO THE ISSUE. >> INTERVENTION IS NOW -- INTERVENTION IS PART OF THE NEW DEFINITION OF A CLINICAL TRIAL SO YOU WILL INCLUDE EVERYTHING. OKAY. RIGHT. I CAN MAYBE REWORD IT AND BRING IT BACK TO YOU. WERE THERE ANY OTHER CONCERNS OR SUGGESTIONS >> THIS IS RUSS. I APPLAUD THE EFFORT TO STREAMLINE COUNCIL IN PARTICULAR SOME OF THE MORE ADMINISTRATIVE ISSUES THAT COME UP IN THE LATER PARTS OF THE APPLICATION BUT I'M UNEASY WITH THE ETHICS BEING PULLED OUT BECAUSE THAT IS A BROAD AREA, I DON'T THINK THAT THERE'S NECESSARILY QUITE THE TECHNICAL GUIDANCE ON WHAT POLICIES ARE BECAUSE THAT COULD BE ALMOST ANYTHING. IF WE ARE GOING TO PULL THINGS OUT AS MARCO SUGGESTS I MIGHT SUGGEST ETHICS COULD BE PULLED OUT OF THAT LIST. >> MAYBE WHAT I WILL DO IS GO BACK AND LOOK AT THE MANDATE AND THE POLICIES AND I'LL RECORE THAT. AND MAYBE COME BACK TO YOU WITH A SLIGHTLY DIFFERENT LIST HERE. ALL RIGHT. ANY OTHER QUESTIONS FOR ANNIE? NOW I WOULD LIKE TO INVITE KAREN COLBERT TO THE PODIUM. >> GOOD MORNING. NICE TO BE HERE WITH YOU TODAY AGAIN, I'M KAREN COLBERT OF NEI BUDGET OFFICER. SO I WOULD LIKE TO MENTION BEFORE I GET STARTED, THAT WITHIN THE BUDGET COMMUNITY WE ARE IN A GRAY AREA RIGHT NOW OUR 2019 SPENDING AND OUR 2020 OPERATING PLANS HAVE NOT BEEN TRANSMITTED TO CONGRESS. SO BECAUSE OF THAT I'M REALLY PROHIBITED FROM SHOWING SPECIFIC DETAILS WHAT WE FUND IN 2019 OR PLANS FOR 2020. SO TODAY I WILL HAVE TO KEEP MY COMMENTS UNLIMIT TO WHAT IS PUBLICLY AVAILABLE INFORMATION. THERE'S STILL GOOD INFORMATION TO KNOW. I WILL START WITH A QUICK RECAP OF 2019, HOPEFULLY YOU CAN HEAR THESE MICS ARE NOT MADE FOR REALLY TALL PEOPLE. LAST FISCAL YEAR NEI OPERATING LEVEL WAS A LITTLE OVER $794 MILLION. AND TO BE CLEAR, THE OPERATING LEVEL IS THE APPROPRIATION MINUS ANY RESCISSIONS AND TRANSFERS. SO THE FUNDING LEVEL YOU SEE WE GET FROM CONGRESS IS NOT THE AMOUNT WE HAVE TO OPERATE WITH. RECENT FUNDING TRENDS OVER SEVERAL FISCAL YEARS REFLECTED WE SPENT 85% OF OUR BUDGET ON EXTRAMURAL RESEARCH, 11% ON INTRAMURAL VERGE AND 4% ON RESEARCH SUPPORT. I HAVE EVERY EXPECTATION WHEN THE 2019 DATA IS RELEASED, THESE TREND WILL HOLD FOR 2019. SO I WANTED TO PROVIDE A LITTLE REMINDER ABOUT WHAT EACH OF THESE CATEGORIES INCLUDE. EXTRAMURAL RESEARCH INCLUDES OUR GRANTS AND CLINICAL TRIALS. THE INTRAMURAL RESEARCH PROGRAM FUNDS ARE INTERNAL PRINCIPLE INVESTIGATORS AND FELLOWS CONDUCTING BASIC TRANSLATIONAL AND CLINICAL RESEARCH. RESEARCH SUPPORT INCLUDES ADMINISTRATIVE BUDGETARY LOGISTICAL AND SCIENTIFIC SUPPORT ACROSS THE NEI AND ENCOMPASSES OTHER FUNCTIONS INCLUDING AWARDING GRANTS, CONTRACT ADMINISTRATION. PLANNING EVALUATION AND OTHER MANAGE MILLIMETER ACTIVITIES. HERE WE HAVE THE NIH AND NEI COMPETING RPG SUCCESS RATES, THIS SLIDE SHOWS 2013 THROUGH 2018 BECAUSE OF COURSE 2019 DATA HAS NOT BEEN RELEASED YET. COMPETING RPG SUCCESS RATE IS A MEASURE THAT CONGRESS LOOKS AT TO VALIDATE PROGRESS TOWARDS ACCOMPLISHING THE GOALS SET FORTH IN THE APPROPRIATION LANGUAGE. NIH DEFINITION OF SUCCESS RATE IS PERCENTAGE OF REVIEWED GRANTS APPLICATION THAT RECEIVE FUNDING. SUCCESS RATES ARE DETERMINE BY DIVIDING NUMBER OF COMPETING APPLICATIONS FUNDED BY SUM OF THE TOTAL NUMBER OF COMPETING APPLICATIONS REVIEWED. APPLICATIONS HAVE A ONE OR MORE SUBMISSION FOR THE SAME PROJECT AND SAME FISCAL YEAR ONLY ACCOUNTED ONCE. SOME GRANTS ARE JOINTLY FUNDED BY MULTIPLE INSTITUTES SO USUALLY THE IC THAT CONTRIBUTES THE MOST MONEY RECEIVES A GRANT CAP. THE DOLLARS ARE CONTRIBUTED TO EACH IC THAT HAS CONTRIBUTED TOWARDS THE PROJECT. EXCLUDED FROM THIS SUCCESS RATE APPLICATION ARE THOSE APPLICATIONS WITHDRAWN BY APPLICANT PRIOR PRIOR TO REVIEW OR RETURNED OR AD MINUTE INVESTIGATIVELY WITHDRAWN BY THE NIH CENTER FOR SCIENTIFIC REVIEW. THE SUCCESS RATE IS HISTORICALLY HIGHER THAN THE NIH AVERAGE AND WE HAVE EVERY EXPECTATION THAT WHEN THE 2019 DATA IS RELEASED THAT WILL CARRY THAT TREND. ON 2019. HERE WE HAVE THE NEI OPERATING LEVELS VERSUS BUYING POWER THROUGH 2019. THE BIOMEDICAL RESEARCH AND DEVELOPMENT PRICE INDEX WHAT WE CALL BIRD PIE IS USED TO CALCULATE HOW MUCH THE NIH BUDGET HAS TO CHANGE TO MAINTAIN OUR PURCHASING POWER. THE RATE IS UPDATED ANNUALLY AND THERE ARE PAGES AND PAGES OF DETAILED EXPLANATION ABOUT HOW IT IS CALCULATED ON NIH WEBSITE, THAT'S FOUND ON THE NIH OFFICE OF BUDGET WEB PAGE. THAT SAID, AS OF JANUARY 2019, THAT UPDATE BIRD PIE IS PROJECTED TO GROW AT 2.7% FOR FY 2019 THROUGH FY 2024. SO AS YOU CAN SEE FROM THE SLIDE, OUR PURCHASING POWER IN 2019 CONTINUES TO BE ABOUT HALF OF WHAT OUR OPERATING LEVEL IS. NOW MOVING ON TO CURRENT YEAR EXCITING TIME. THIS SLIDE PROVIDES A CROSSWALK 2019 ACTIVE APPROPRIATION THROUGH THE CURRENT FY 2020 APPROPRIATION. THE FY 2020 PRESIDENT'S BUDGET PROPORTIONED A 13% DECREASE TO THE NIH BUDGET AND A 14% DECREASE TO THE NEI BUDGET. IF THE PRESIDENT'S BUDGET REQUEST HAD COME TO FRUITION, NEI WOULD HAVE HAD TO CUT APPROXIMATELY 170 AWARDS AND $95 MILLION FROM THE EXTRAMURAL RESEARCH BUDGET. HOWEVER CONGRESS REJECTED THAT PLANNING DOCUMENT AND SUGGESTED INCREASES TO THE NIH AND NEI BUDGETS. THE HOUSE PROPOSED A $2 BILLION INCREASE TO THE NIH AND A $39 MILLION INCREASE TO NEI. THE SENATE PROPOSED A $3 BILLION INCREASE TO NIH, AND A $43.7 MILLION INCREASE TO NEI. ONCE THE HOUSE AND SENATE CAME TOGETHER IN CONFERENCE, THE END RESULTS WAS 6.7% INCREASE TO THE NIH BUDGET WHICH IS ABOUT MIDWAY BETWEEN WHAT THE HOUSE AND SENATE EACH PROPOSED. AND NEI ULTIMATELY RECEIVED A 3.5% INCREASE WHICH IS LESS THAN WHAT THE HOUSE AND SENATE PROPOSED. YOU MIGHT WONDER WHY THERE'S A DIFFERENCE BETWEEN THE NIH INCREASE AND THE INCREASE NEI RECEIVED, THAT'S BECAUSE OF TARGET RESEARCH SPELLED OUT IN THE LANGUAGE ANDLY TALK A LITTLE BIT ABOUT THOSE FUNDING AREAS. THE NEXT TWO SLIDES SHOW NIH AND NEI LEVELS SINCE SEQUESTRATION. JUST TO REMIND EVERYONE SEQUESTRATION WAS, IN MARCH 2013, NIH WAS REQUIRED BY STATUTE TO CUT APPROXIMATELY 5% OR $1.6 BILLION OF ITS FY 2013 BUDGET. IN THAT YEAR NIH FUNDED 640 FEWER RPGs VERSUS 2012 AND NON-COMPETING RPGs WERE CUT ON AVERAGE BY 5% ACROSS NIH. IT TOOK UNTIL FY 16 TO RECOVER FROM THAT SEQUESTRATION PERIOD. SINCE 2016 BOTH NIH AND NEI HAVE RECEIVED MODERATE I WANTED TO HIGHLIGHT FOR YOU A FEW RESEARCH PARTIES THAT WERE IN THE 2020 APPROPRIATIONS BILL. ALZHEIMER'S RESEARCH IS A CATEGORY THAT HAS RECEIVED SOME PROMINENCE, $2.8 BILLION FOR ALZHEIMER'S RESEARCH, 500 MILLION FOR BRAIN, NIH TOLD TO SPEND NO LESS THAN 500 MILLION-DOLLAR ON OPIOIDS RESEARCH. THE BILL ALSO INCLUDES LANGUAGE THAT DIRECTS NIH CKC TO EACH SPEND $12.5 MILLION ON FIREARM RESEARCH, INCLUDING TRACKING GUN RELATED DEATH AND INJURY, AS WELL AS IDENTIFYING CORRELATIONS LIKE THE RELATIONSHIP BETWEEN VICTIM AND SHOOTER. I BELIEVE THAT'S NEW. THE BILL HAD QUITE A BIT OF TEXT RELATED TO SEXUAL HARASSMENT, REQUIRING INSTITUTIONS TO NOTIFY AGENCY WITH KEY PERSONNEL, NAMED O AN NIH GRANT AWARD REREMOVED BECAUSE OF SEXUAL HARASSMENT CONCERNS AND SUBMIT TO CONGRESS PLANS TO IMPLEMENT MEASURES THAT ATTEND TO HARASSMENT AND EXTRAMURAL SETTINGS WITH THE SAME LEVEL OF ATTENTION AND RESOURCES AS THOSE DEVOTED TO RESEARCH -- OTHER RESEARCH MISCONDUCT. NIH DIRECT TO SUPPORT RESEARCH THAT INCLUDES A PSYCHOLOGY UNDERLYING HARASSMENT AND THE EXPERIENCES AND OUTCOME OF STUDY VERSE GROUPS WHEN SUBJECTS TO HARASSMENT. ADDITIONALLY, TO COLLABORATE WITH THE NATIONAL ACADEMY OF SCIENCES ENGINEERING AND MEDICINE TO DEVELOP BEST PRACTICES, FOR DEVELOPING MORE DIVERSE INCLUSIVE CULTURES. THE BILL DOES NOT CHANGE PREVIOUS LANGUAGE RELATED TO INDIRECT COST AND DOES NOT CONSOLIDATE THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY NIH HAS BEEN PROPOSED IN SEVERAL RECENT PRESIDENT'S BUDGETS. THE 21st CENTURY CURES ACT. THIS SLIDE SERVES AS A REMINDER ABOUT THE CURES FUNDING WHICH WAS SIGNED INTO LAW ON DECEMBER 12, 2016. THE CURES ACT PROVIDES FUNDING TO THESE FOUR HIGHLY INNOVATIVE SCIENTIFIC INITIATIVES, PRECISION MEDICINE MOW KNOWN AS THE ALL OF US PROGRAM, BRAIN INITIATIVE, CANCER MOON SHOT, REGENERATIVE MEDICINE. THE CURES ACT IS A TENURE PLAN THAT ALLOCATES $4.8 BILLION TO NIH. HOWEVER THE FUNDING HAS TO BE APPROPRIATED FROM CONGRESS EACH YEAR BEFORE IT CAN BE SPENT. AND I WOULD LIKE TO POINT OUT THAT 2020 IS THE FINAL FUNDING YEAR FOR CURES REGENERATIVE MEDICINE. MOVING FORWARD TO 2021. WITHIN THE BUDGET COMMUNITY WE ARE TASKED WITH THREE FISCAL YEAR AT ONE TIME M. SO RIGHT NOW OVER THE PAST FEW MONTHS WE HAVE COMPLETE REPORTING IN 2019, WE ARE CURRENTLY EXECUTING THE FY 2020 BUDGET AND FORMULATING THE 2021 PRESIDENT'S BUDGET REQUEST. THIS SLIDE REFLECTS TENTATIVE UPCOMING DATES RELATED TO THE BUDGET PROCESS. I ALSO SAY BY LAW ON THE FIRST MONDAY IN FEBRUARY THE PRESIDENT SCHMITZ TO CONGRESS A DETAILED BUDGET REQUEST FOR THE UPCOMING FISCAL YEAR BEGINNING OCTOBER 1st. THIS YEAR, THE PRESIDENT'S BUDGET RELEASE IS DELAYED BECAUSE STATE OF THE UNION I DON'T KNOW ADDRESS HAS BEEN SCHEDULED FOR FEBRUARY 4. SO THE PRESIDENT'S BUDGET WILL BE ONE WEEK LATE. WE HAVE A TENTATIVE HEARING SET FOR LATE MARCH, PROBABLY MARCH 26, AND THE HOUSE HEARING SCHEDULE HAS NO T BEEN DETERMINED YET. I WILL LA SAY LAST YEAR IN ADDITION TO NORMAL APPROPRIATIONS HEARING, THERE WAS A HEARING SCHEDULED FOR THOSE ICs THAT DON'T TYPICALLY HAVE THE OPPORTUNITY TO SPEAK BEFORE CONGRESS INCLUDED WERE THE NATIONAL INSTITUTES OF BIOMEDICAL IMAGING AND ENGINEERING. THE NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES. THE NATIONAL CENTER FOR COMPLIMENTARY INTEGRATED HEALTH, THE NATIONAL TRANSLATION HAL SCIENCES AND NATIONAL LIBRARY OF MEDICINE, AND THERE'S TALK ABOUT HAVING SIMILAR HEARING THIS YEAR. SO THAT CONCLUDES MY SLIDES. HAPPY TO ANSWER ANY QUESTIONS THAT YOU MIGHT HAVE. YES. FROM >> THANK YU VERY MUCH FOR THAT UPDATE. CAN YOU JUST EXPLAIN WHAT THE IDE PEDIATRIC NETWORK IS? YOU MENTIONED AS PART OF THE HIGHLIGHTS OF THE BILL. >> SURE. I WOULD HAVE TO LEAVE IT TO SCIENTIFIC STAFF TO EXPLAIN >> PARTICULAR LEGISLATION THE IDEA GRANTS ARE STATES THAT DON'T NORMALLY RECEIVE LARGE AMOUNTS OF FUNDING FOR NIH AND SPECIAL FUNDING IS SET ASIDE TO DIRECT I SUSPECT PART OF THAT PROGRAM. >> THE NEI PARTICIPATED IN THE PAST. WE SUBMIT GRANTS NEAR THE FUND LINE BUT DIDN'T QUITE MAKE IT AND THEY PROVIDE FUND FOR US TO FUND THOSE GRANTS. >> JUST TO MENTION WHEN KAREN DESCRIBED THE HEARINGS, NEI WAS ACTUALLY INVITED TO SPEAK TO CONGRESS BUT THE INVITATION TO NEI WAS ISSUED TOO LATE SO IT WAS DENIED BY THE WHITE HOUSE. WE HAVE HEARD THAT WE ARE UP IN MARCH. SO WE WILL GET OUR TURN TO SPEAK IN FRONT OF CONGRESS IT SEEMS. NEXT, DR. SHEFA GORDON WILL UPDATE ON THE STRATEGIC PLANNING ACTIVITIES AND THE NEI STRATEGIC PLAN DEVELOPMENT. >> STRATEGIC PLANNING IS FUN, MORE FUN WHEN CONGRESS HAS BEEN A LITTLE BIT MORE GENEROUS GIVING US A LARGER INCREAE THAN IN THE PAST. SO I'M SHEFA GORDON, DIRECT THE OFFICE OF PROGRAM PLANNING ANALYSIS AT NEI. I WANT TO -- WE DID DISCUSS PLANNING IN OCTOBER IN GENERAL. I WANT TO GIVE AN UPDATE ON THE PROGRAM PLANNING PANELS BRING TOGETHER AS WELL AS REQUEST FOR INFORMATION THAT SANTA ALLUDED TO IN HER OPENING REMARKS. WHEN I PRESENTED TO COUNCIL IN OCTOBER I PRESENTED DIFFERENT AREAS OF EMPHASIS THAT WE WANT TO FOCUS OUR PLAN OPPOSED TO THE CORE PROGRAMS. COUNCIL THOUGHT IN PRINCIPLE THAT WAS GOOD. YOU DIDN'T CARE FOR THE GRAPHIC I HAD UP THERE WHERE EVERYTHING WAS ON EQUAL PLAYING -- FOOTING. PARTICULARLY BECAUSE THERE WERE -- WE WERE MIXING DIFFERENT TECHNIQUES AND AIRS OF SCIENCE. YOU ASKED FOR HIERARCHICAL GRAPHIC WHICH WAS HELPFUL IN FRAMING HOW WE THINK -- PUTTING THIS TOGETHER THIS PLAN SO WE PUT THIS TOGETHER WITH DIFFERENT RESEARCH DOMAINS, VISUAL SYSTEM AND HEALTH AND DISEASE IS TAKING THE BASIC TO TRANSLATIONAL TO CLINICAL RESEARCH HUMAN BIOLOGY AS WELL AS ANIMAL AND CULTURE SYSTEMS. CAPITALIZE ON EMERGING FIELDS LOOKING -- THESE ARE NOT FOCUSING ON TECHNIQUES FOR REGENERATIVE MEDICINE DATA SCIENCE THESE ARE FOCUSING HOW WE CAN PUSH OUR DATA COLLECTION HOW WE PUSH OR DEVELOP OUR RESEARCH IN THESE AREAS. THE THIRD AREA PREVENTING VISION LOSS AND HINTING WELL BEING, THIS IS REALLY LOOKING PUBLIC HEALTH PATIENT PERSPECTIVE SO INDIVIDUAL QUALITY OF LIFE IS WHAT THE REHABILITATION LOOKING AT ISSUES OF SOCIAL ISOLATION AND DEPRESSION, PATIENT PERSPECTIVE AND PUBLIC HEALTH AND HEALTH DISPARITIES RESEARCH IS REALLY FOCUSING ON EPIDEMIOLOGY HEALTH SERVICES RESEARCH HEALTH ECONOMICS H. SO WE -- WE HAD BEEN WORKING AT TAKING SOME OF THE INPUT FROM REQUEST FOR INFORMATION AND I WILL TALK ABOUT THAT IN A SECOND. BEEN USING THAT TO FRAME WHAT WE WANT TO COVER IN EACH OF THESE PANELS. AND ALSO PUTTING TOGETHER PANELS. I HAVE NOT -- WE HAVE NOT CONTACTED THE -- OUR LIST OF PANELISTS ARE PRETTY GOOD DRAFT FORM BUT WE HAVE NOT REACHED OUT TO THEM YET SO I'M NOT PREPARED TO ODE HOWEVER WE DID -- THIS FRAMEWORK WHICH I SENT YOU OVER EMAIL AND COUNCIL DID ENFORCE THIS FRAMEWORK IN OCTOBER. WE ALSO ASK FOR VOLUNTEERS AND DID GET THEM FOR COUNCIL SO I THINK THOSE OF YOU WHO VOLUNTEERED TO BE ON THESE PANELS, SO LET ME MENTION THE COUNCIL MEMBER VOLUNTEERS BUT ALSO MENTION NIE STAFF, EACH PANEL HAS ONE OR TWO PROGRAM DIRECTORS FROM OUR EXTRAMURAL DIVISION AS WELL AS POLICY ANALYST OR TWO FROM MY OFFICE SO MECHANISMS WHICH REALLY IT'S KIND OF WHAT'S BEYOND GWAS, WE HAVE -- WE DID SAY YOUR COUNCIL TERM ENDS IN MAY AND WE HOPE TO HAVE THESE PANELS IN -- THIS PANEL IS MANY FEBRUARY MARCH AND APRIL SO BEFORE YOU ROTATE OFF. WE APPRECIATE YOU REALLY WORKING TO THE LAST DAY OF YOUR COUNCIL EXTENDED COUNCIL STAY. FROM MY OFFICE, NORA WONING AND CHUCK WRIGHT -- GRACE CHEN IS PROGRAM DIRECTOR POLICY YOU MAY EXPECT EMAILS FROM NORA, JOSE ALONSO IS WORKING ON BIOLOGY NEUROSCIENCE AND VISION, AND WE HAVE MARTHA AND TOM GREENWELL AND FROM MY OFFICE, WE ARE WORKING ON THAT NEUROSCIENCE PANEL. RUSS VAN GERDER IS -- SOME VOLUNTEER FOR A FEW PANELS WE ARE TRYING TO BALANCE OUT SO RUSS VOLUNTEERED FOR THE IMMUNE SYSTEM AND EYE HEALTH AND WE HAVE GEORGE MCKEY AND (INDISCERNIBLE) AS WELL AS MYSELF AND CHUCK WRIGHT ON THAT PANEL. REGENERATIVE MEDICINE, WE HAVE OFFICE OF REGENERATIVE MEDICINE, AND AMBER REED, THAT OFFICE WILL BE POLICY ANALYST ON THAT, (INDISCERNIBLE) AND MARCO ARE VOLUNTEER FROM COUNCIL. WE HAVE MARY ANN REDFORD PROGRAM DIRECTORS WORKING WITH THAT PANEL. DATA SCIENCE WE HAVE DENNIS LEVI WHO IS ROTATING OFF, WE ARE GOING TO SQUEEZE EVERY OUNCE OF THAT WORK OUT BEFORE YOU LEAVE. JAMES GOU AND JERRY -- PROGRAM DIRECTOR AND KERRY GETTS WORKING ON THAT PANEL AS WELL. FOR THE INDIVIDUAL QUALITY OF LIFE WE HAVE ANDY HARTMAN FROM COUNCIL AND SHERRI WIGS AND DON EVERETT FROM PROGRAM DIRECTORS AND RACHEL BISHOP IS WORKING ON THAT ONE AND PUBLIC HEALTH AND HEALTH DISPARITIES RESEARCH WE ACTUALLY HAVE ONE OF THE PANEL MEMBERS WE HAVE SOMEONE WHO IS ON THE AGING COUNCIL WE ARE THINKINGD OF FROM THE NATIONAL INSTITUTE OF AGING. AND NORA WOMG FROM MY OFFICE IS WORKING WITH JIMMY LEE FROM THE PROGRAM OFFICE. ONCE YOU TALK REQUEST FOR INFORMATION,, AS WE PRESENTED LAST TIME WE WERE ASKING FOR WHAT ARE THE BIG SCIENTIFIC DISCOVERIES SINCE 2012, WHAT NEW OPPORTUNITIES HAVE BEEN ENABLED BY SCIENTIFIC DISCOVERY TECHNOLOGY DEVELOPMENT AND WHAT NEEDS AN GAPS IN RESEARCH AND HEALTH QUALITY OF LIFE ADDRESSED BY NEI. WE ISSUED RFI ON OUR WEBSITE NOVEMBER 15th WE HAD A WEB FORUM, WE ALLOWED REASON WE USED WEB FOR RUM IS ALLOWING PEOPLE TO SUBMIT SOMETHING ANONYMOUSLY AND WE DID GET 50 RESPONSES THAT DIDN'T IDENTIFY THEMSELVES. WE CLOSED IT ON JANUARY 9, WE BROADCAST THIS THROUGH THE NIH GUIDE WHICH GOES TO RESEARCH COMMUNITY, THE FEDERAL REGISTER WHICH THEN WAS PICKED UP BY NEWS OUTLETS, I WAS SURPRISED WE GOT PEOPLE CAME OUT IN THEIR FEDERAL REGISTER FEW WEEKS AFTER WE RELEASED, THERE WAS UPTICK SO IT'S NOT SOMETHING WE DON'T USE FEDERAL REGISTER BUT IT WAS FOUND IT TO BE PARTICULARLY USEFUL. WE DID SEND EMAIL BLAST TO ALL CURRENT NEI GRANTEES. THEN WE ALSO HAVE OUR -- THE PROGRAM HAS DISTRIBUTION LIST OF 64 PARTNERS, ARVO, METRIC ASSOCIATION AMERICAN ACADEMY OF OPHTHALMOLOGY AND OTHER PARTNERS WHO OFTEN DISTRIBUTE TO THEIR LIST, WE ALSO SEND TO PARTICULAR STAKEHOLDERRERS TO PREVENT BLINDNESS, (INDISCERNIBLE) AND HIS MEMBERS, AMERICAN PUBLIC HEALTH ASSOCIATION. WE WERE TRYING TO BOTH REACH THE RESEARCH COMMUNITY AS WELL AS PUBLIC PATIENTS, WE WERE SUCCESSFUL AND I WAS PLEASED WITH THE RESPONSES. WE GOD 262 RESPONSES, ONE TRICKLED IN YESTERDAY. WE FOUND IT INTERESTING. YOU CAN SEE FROM THIS GRAPH, LARGE CITIZEN APPLICANTS RESPONDED, I WILL GET TONA IN A SECOND. EQUAL NUMBER OF ACADEMICS, PEOPLE -- WE DIDN'T ASK FOR THEM, WE HAD AN OPPORTUNITY TO IDENTIFY THEIR NAMES, EMAIL AND AFFILIATION BUT WE DIDN'T ACTUALLY -- THIS WAS US LOOKING AT IF THEY IDENTIFIED FROM SUCH UNIVERSITY. THESE ARE NOT SELF-IDENTIFIED CHARACTERIZATIONS. WE DID HAVE 50 RESPONSES ANONYMOUS. THEN WE GOT A BIG RESPONSE FROM EDUCATORS OF PEOPLE FROM SCHOOLS FOR THE BLIND. WE HAD CLINICIANS SOME OVERLAP WITH ACADEMICS IN THAT REALM BUT THERE WERE ALSO PEOPLE FROM PRIVATE PRACTICE. PHYSICAL THERAPISTS PUBLIC IDENTIFY THEMSELVES. WE DID GET A FEW ORGANIZED RESPONSES THE FROM SOCIETIES ORGANIZATIONS, FEW GOVERNMENT RESPONSE AND INDUSTRY RESPONSE. O LET'S DIVE INTO, WE ARE ORGANIZED BY OUR RESEARCH DOMAIN. NOTICE THE NUMBERS HERE ARE A LITTLE HIGHER THAN THE TOTAL RESPONSES. SO WE HAD 252 INDIVIDUAL RESPONSE BUT SOMETIMES THEY WERE COMMENTING ON DIFFERENT AREAS, WE ARE COUNTING EACH ON A PARTICULAR AREA. SEPARATELY SO THAT'S WHY THE NUMBERS ADD UP TO MOR THAN TOTAL BUD MORE DISEASE THAN PUBLIC AREA, SO LET'S DIVE DEEPER INTO VARIOUS EMPHASIS. YOU WILL NOTICE THAT BY AND LARGE, THE BIGGEST RESPONSES WERE IN THE AREAS OF NEUROSCIENCE, FOLLOWED BY INDIVIDUAL QUALITY OF LIFE, WE DID HAVE A LOT OF PATIENTS AND PARENTS RESPONDING. THEN ALSO PUBLIC HEALTH. SO THERE'S ALSO 25 COMMENTS AGAIN WE ALSO DIDN'T ASK PEOPLE TO ORGANIZE THEIR COMMENTS BY AREA OF EMPHASIS, WE DID THAT AFTER THE FACT. SO THERE WAS SOME COMMENTS THAT DIDN'T APPLY TO -- WE DID PUT THE AREAS OF EMPHASIS ON -- WITH THE RFI SO YOU CAN SEE HOW WE ARE THINKING BUT WE DIDN'T ASK SPECIFIC PEOPLE TO COMMENT ON THOSE. MOST TALKED IN ONE OF THOSE AREAS. COMMENTS ENDORSING THE WAY WE ORGANIZED THE PLAN. TESTIFY -- WHEN YOU DIVE DEEPER INTO WHAT WAS THE LARGE DRIVER OF RESPONSES, EVERYTHING IN PATTERN RESPONSES ARE RELATED TO CORTICAL OR CEREBRAL VISUAL IMPAYMENT. THIS LARGELY FUELED SOME OF THE RESPONSES IN NEUROSCIENCE AND LARGELY IN THE INDIVIDUAL QUALITY OF LIFE. SO CVI FOR THOSE WHO WHO REMEMBER ABOUT THREE YEARS AGO, WE HAD A PRESENTATION BY -- COUNCIL WHO EXPLAINED THE ORIGIN AND WHAT'S KNOWN ABOUT CVI IT IS USUALLY CAUSED BY A STROKE IN UTERO THAT PREVENTS -- OF THE BRAIN, SOMETIMES THERE'S SEVERELY PREMATURE INFANTS THAT MAY NOT HAVE SECURE PRIEF VIVE IN THE PAST ARE NOW SURVIVING TO -- THROUGH CHILDHOOD. CORTEX ISN'T FULLY DEVELOPED OR THERE'S TRAUMA EARLY ON. THERE'S A FEW REASONS BUT ULTIMATELY THE VISUAL AREAS OF THE BRAIN HAVEN'T DEVELOPED NORMALLY. THESE PATIENTS HAVE NORMAL OCULAR FUNCTION, OPTOMETRIST, OPHTHALMOLOGIST IS FINE BUT FACIAL RECOGNITION OR TENSION ISSUES. SO THIS WAS AS SOMETIMES HAPPENS WHEN YOU ARE HAVE REQUEST FOR INFORMATION, CERTAIN GROUPS STAKEHOLDER GROUPS WILL REALLY SEIZE ON IT SAY THIS IS AN OPPORTUNITY TO VOICE OUR CONCERNS. THAT DID DOMINATE. WE GOT 64%, TWO-THIRDS RESPONSE RELATED TO CVI. OFTEN WHEN YOU HAVE A GROUP THAT RESPONDS TO SOMETHING THEY MIGHT HAVE A COOKIE CUTTER, HERE IS LANGUAGE YOU NEED TO SEND, MAKE SURE THEY HEAR YOUR VOICE. IT'S GOOD AS GOOD DATA POINT I THINK FOR THE BY AND LARGE ALMOST EVERYONE OF THESE PARENTS OR TEACHESSERS OF VISUALLY IMPAIRED INDIVIDUAL WRITING THEIR INDIVIDUAL STORIES POIGNANT POWERFUL STORIES. T SO READING THROUGH THEM. IT WAS INTERESTING TO SEE THAT TO GET THAT PATIENT PERSPECTIVE. THAT'S OTHER ISSUES THAT CAME UP, THAT'S NOT THE WHOLE STORY BUT THAT WAS CERTAINLY A MESSAGE WE HEARD LOUD AND CLEAR FROM REQUEST FOR INFORMATION. JUST A LITTLE MORE DETAIL HERE ARE THE OTHER TOPICS THAT BUMP UP A BIT. WON'T GO THROUGH ALL THESE, WE ALSO GET THINGS ALONG OUR CORE PROGRAMS A LOT OF COMMENTS ON REFRACTIVE ERROR WE ARE MAKING SURE WE HAVE COVERAGE IN OUR PLANNING. EPIDEALOLOGY, WE DID HAVE COMMENTS ON MENTAL HEALTH, SOCIAL ISOLATION IN PEOPLE WITH VISUAL IMPAIRMENT AND DEPRESSION. WE HAVE COMMENTS ABOUT LOOKING AT ECONOMICS AND COST ANALYSIS, ANOTHER GROUP WE SAW MIRRORED LOOKING AT BEHAVIORAL RESEARCH PARTICULARLY IN NEUROSCIENCE PANEL. TRYING TO UNDERSTAND WHAT IS MEANT BY BEHAVIORAL RESEARCH, A LITTLE LOOK CLOSER LOOK,ERS OFTEN TALKING ABOUT PSYCHOPHYSICS, ATENSION, LITTLE AMBLYOPIA, OTHER COMMENTS, VISUAL PROSTHESIS TO LEARN HOW TO UNDERSTAND BEHAVIOR ADAPTING TO YOUR PROSTHESIS. WE MAKE SURE PARTICULAR PANELS THAT WE HAD THAT EXPERTISE COVERED. AGING IS A BIG THEME. HEALTH EDUCATION, AGAIN, A LARGE IMPACT FROM THE COMMUNITY THE WORK -- THEY WERE ALSO -- WHEN I SAY CBI WE DID A LOT -- WE ALSO HAVE A LOT OF CLINICIANS THAT I HAVE SEEN TOO SO WE HAD A LOT -- A LOT OF IT WASN'T JUST DO SOMETHING THERE WAS CONSTRUCTIVE IDEAS IN THOSE AREAS. I WON'T GO THROUGH THIS WHOLE SLIDE BUT JUST WAYS WE TRIED TO START TO INCORPORATE THE FEEDBACK FROM -- LIKE I SAID CVI WAS ITS OWN TYPE OF RESPONSES, SO WE DID MADE SURE WE HAVE A PANELIST IN OUR NEUROSCIENCE PANEL, REHABILITATION INDIVIDUAL QUALITY OF LIFE PANEL, THREE PANELISTS THAT FOCUS ON CBI, MAIN RESEARCH INTEREST. INCLUDING ONE OF THOSE IS SOMEONE WHO IS EDUCATOR FOR THE BLIND. SOME THINGS WE DON'T HAVE REPRESENTED WE WANT TO BRING UP FOR DISCUSSION THINGS LIKE HOW WE DEVELOP SCREENING TOOLS, THAT CAME UP A LOT DEVELOPING PATIENT REGISTRY. WE DID TALK ABOUT WHAT'S NEXT IN GENE THERAPY AND DEVELOPING MORE RELEVANT ANIMAL MODELS, THINGS WE TYPICALLY HAVE IN OUR REQUEST FOR INFORMATION, INFORMATION BEHAVIORAL NEUROSCIENCE, IMMUNOLOGY, NOT THAT MANY COMMENTS ON IMMUNOLOGY BUT ONE THING WE RESPOND TO IS MAKE SURE WE'LL COVER MICROBIOME IN THE IMMUNOLOGY PANEL. REGENERATIVE MEDICINE, INCORPORATE EXOSOMES, EXTRA CELLULAR RNA REGENERATIVE MEDICINE PANEL. SO WHICH HAD THAT EXPERTISE COVERED. DATA SCIENCE, THERE WAS A LOT ON THE DATA MANAGEMENT SIDE AS WELL AS ON THE PREDICTIVE MODELING SIDE OF THINGS. I DID MENTION WE WANT TO HAVE AN EXPERT ON SOCIAL ISOLATION IN OUR PANEL ON QUALITY OF LIFE WE TALK ABOUT BRINGING TECHNOLOGY LIKE TELEMEDICINE INTO OUR PANEL. PUBLIC HEALTH. LOOKING EVALUATING EFFECTIVENESS OF HEALTH SERVICES RESEARCH. WHAT TYPE -- AGAIN AS NIH RECENT ORGANIZATION A LOT OF THINGS IMPROVE ACCESS TO CARE NIH -- IN THE CONTEXT OF RESEARCH, WHAT TYPE OF SERVICES WHAT MOST EFFECTIVE SERVICES WE CAN DO RESEARCH ON THAT DOES FALL WITHIN OUR -- WE HAVE EXPERTISE ON THAT. THAT FALLS INTO BEHAVIORAL SCIENCE HEALTH ECONOMICS AND OUR PANEL WE ARE TRYING TO LOOK ATTY VERSE POPULATIONS, HAVING REPRESENTATION FROM VA COMMUNITY HEALTH SERVICE FROM CLINICS NATIVE AMERICAN HISPANIC POPULATIONS AFRICAN AMERICAN POPULATION SO WE ARE TRYING TO GET THAT PRESENTATION ON OUR PANEL. THAT IS HOW WE ARE TRYING TO INCORPORATE RFI INTO OUR PLANNING PANEL SO NEXT STEPS LIKE I SAID WE ARE -- HAVE AT LEAST INTERNALLY PRETTY MUCH FINALIZED WHO WE THINK WOULD BE GOOD FOR THESE PANELS, WE WANT TO KEEP THEM TO ABOUT TEN PEOPLE BECAUSE WE WANT THESE ON A ZOOM CONFERENCE CALLS, SERIES OF THREE CALLS, ONE IN FEBRUARY, MARCH AND APRIL OR SO. I THINK THE PANELS -- THEY ARE SO BROAD. THEY AVERAGE 12 PEOPLE PANEL AT THIS POINT. WE ARE GOING TO REACH OUT TO YOU, EITHER GOING TO FOND YOU DURING THE BREAKS OR TODAY OR SEND EMAIL SHORTLY IF YOU ARE ONE OF THE VOLUNTEERS. AND ALSO WE WORK -- NOT ASKING COUNCIL MEMBERS TO BE CHAIRS OF EACH PANEL BUT WE WILL WORK WITH YOU AND THE CHAIRS TO HELP FINALIZE MAYBE SOME EXPERTISE WE ARE MISSING BEFORE WE REALLY SEND -- INVITE THE PANELISTS. BUT WE HOPE TO INVITE THEM THE NEXT FEW WEEKS. AND SET UP PANEL MEETINGS. HOPEFULLY THE GOAL IS TO HAVE A PLAN OUT BY THE YEAR BEFORE THE YEAR 2020 IS OVER. I DON'T HAVE A SLIDE FOR IT BUT AT THE SAME TIME NIH IS LAUNCHING AN NIH WIDE PLAN WHICH IS THIS IS ONLY THE SECOND TIME NIH PLAN FIVE YEARS AGO, FOUR YEARS AGO AND WE ARE JUST STARTING THE EARLY PHASES OF PLANNING. WHEN NIH DOES A PLAN IT IS LOOKING MORE AT THE ADMINISTRATIVE THINGS AND CROSS CUTTING THEMES, LEE THE SCIENCE AT INDIVIDUAL INSTITUTES BUT WHEN WE INTERFACE WITH THAT, ALSO DEVELOPING THAT PLAN, WE ARE ALSO PUTTING TOGETHER AN RFI THAT SHOULD BE RELEASED IN THE END OF FEBRUARY SO BE ON THE LOOK OUT FOR THE NIH WIDE PLAN. WITH THAT, LET ME TAKE QUESTIONS >> ANY COMMENTS? THANK YOU SHEFA. DR. STEVE BECKER WILL GIVE AN UPDATE ON OFFICE OF REGENERATIVE MEDICINE. >> THANK YOU. I'M PLEASED TO BE ABLE TO DESCRIBE OUR VISION FOR NEW OFFICE OF REGENERATIVE MEDICINE AT NEI. JUST A LITTLE BIT ABOUT THE BACKGROUND OF FOR THIS OFFICE, THROUGH WORKSHOPS AND MEETINGS REALLY CAN BENEFIT FROM COORDINATION AMONG DIFFERENT DISCIPLINES AND BY PROVIDING MORE RESOURCES. THIS IS NOT SOMETHING NEW, WHEN THE INDUCED PLURIPOTENT STEM CELL TECHNOLOGY CAME ONLINE MORE THAN A DECADE AGO, NIH ACTUALLY STOOD UP THROUGH ITS COMMON FUND INITIATIVE OF THEIR OWN CENTER FOR REGENERATIVE MEDICINE, I WAS FORTUNATE TO RECEIVE MY TRAINING UNDER THAT PROGRAM. THEIR GOAL WAS TO CATALYZE INTRAMURAL ADOPTION OF STEM CELL TECHNOLOGIES. BUT THOSE SAME PRINCIPLES AND TECHNIQUES ARE REALLY WHAT WE ARE EMBRACING HERE WITH OURS. SO I'LL DESCRIBE A LITTLE BIT ABOUT OUR MISSION P. SO REALLY WE ARE PROVIDING SOME BOTH AD MINUTE INVESTIGATIVE AND SCIENTIFIC SUPPORT TO BOTH INTERNAL SATISFY AND TO RESEARCH EXTRAMURALLY AND INTRAMURALLY. WE ARE GOING TO COLLABORATE ACROSS THE MINI NIH. THERE'S OTHER REGENERATIVE MEDICINE PROGRAMS AND EXPERTISE THAT CAN BE TAPPED INTO A LOT OF ISSUES REGARDING DIFFERENTIATION MANUFACTURING ARE CROSS CUTTING IN THAT WAY. WE INTEND TO PROMOTE COLLABORATION FROM AMONG DIVERSE FIELDS TO ACCELERATE INNOVATION IN REGENERATIVE MEDICINE. I WANT TO GIVE AN EXAMPLE OF HOW THIS WAS DONE BY -- AT THE NIH LEVEL THAT DIRECTLY IMPACTED OUR INSTITUTE. SO WHEN CENTER FOR REGENERATIVE MEDICINE AT THE NIH WAS LAUNCHED IN 2010, THAT I LAUNCHED PILOT PROJECTS ON INTRAMURAL FOR INTRAMURAL INVESTIGATORS AND ONE OF THE BENEFIT -- BENEFICIARIES. THE EXPERTISE BROUGHT TO IT WE ARE HERE TODAY TEN YEARS LATER AND ARE PLEASED TO ANNOUNCE WE HAVE A CLINICAL TRIAL. THAT LESSENED THAT JOURNEY RESOURCES, THE INTRAMURAL RESEARCH PROGRAM BENEFITED FROM, WE WANTED TO IMPRINT AND EXTEND TO THE EXTRAMURAL RESEARCH COMMUNITY. WHAT ARE TYPES OF THINGS WE CAN PROVIDE? WE TELL PEOPLE ABOUT FUNDING. THAT IS OUR MAIN INTEREST. FINDING OUT HOW TO SUPPORT THE STEM CELL RESEARCH. THAT'S NOT FROM NEI BUT OTHER TRANS-NIH INITIATIVES. THERE IS THE BRAIN INITIATIVE, THE NCATS TISSUE CHIP PROGRAM THAT MIGHT BE OF INTEREST. THAT'S OTHER FUNDING ENTITIES SO THERE'S DIFFERENT DOD AND NIST FUNDED MANUFACTURING INSTITUTE THAT FOCUSES ON REGENERATIVE MEDICINE CAPACITY FOR MANUFACTURING. SO WE WANT TO SHARE ALL THIS INFORMATION WITH EXTRAMURAL RESEARCH APPLICANTS, AND THERE'S OPPORTUNITIES TO COLLABORATE WITH INTRAMURAL RESEARCHERS AND WITH INDUSTRY. SO PROGRAM THAT NCATS HAS DEVELOPED FROM THAT ORIGINAL NIH CENTER FOR REGENERATIVE MEDICINE IS STEM CELL TRANSLATIONAL LABORATORY AND LEE TIMES A YEAR HAVE OPPORTUNITIES TO EXTENDED TO SOLICIT PROPOSALS FROM EXTRAMURAL INVESTIGATORS TO COLLABORATE OVERCOMING SOME OF THE TRANSLATIONAL HURDLES IN REGENERATIVE MEDICINE. SO ONCE WE DEVELOP THESE TOOLS, THESE TECHNIQUES, THESE METHODS, WE WANT TO PUBLICIZE THEM. I WILL GET INTO MORE ABOUT THOSE DETAILS. SO WHEN WE TALK ABOUT SUPPORTING STEM CELL RESEARCH INFRASTRUCTURE. A LOT OF TIMES WE ARE ASKING WHERE CAN I GO TO GET TISSUE. HAS TO BE CONCEPTED FOR THAT USE AND THINGS -- CONSENTED FOR USE IN THINGS LIKE THAT. THERE'S USE, ARBO IDENTIFIED THE I FIND PROGRAM TO OUTEYE TISSUE, THE NIH HAS ITS OWN PROGRAM SUPPORTED BY THE OFFICE OF DIRECTOR PART OF OUR RESEARCH INFRASTRUCTURE PROGRAM, THE HTORR, THAT'S ADMINISTERED BY NBRI THAT PROMOTES GATHERING TISSUES. REALLY, WHEN PEOPLE ONCE THEY GET TISSUE NEED TO KNOW HOW TO GENERATE STEM CELL LINES AND DIFFERENTIATE THEM INTO THEIR TISSUE OR CELL OF INTEREST SO THERE'S LOTS OF SERVICE PROVIDERS, WE CAN PROVIDE THAT BUT THERE'S ALSO LOTS OF PUBLISHED PROTOCOLS THAT ARE OUT THERE. UNFORTUNATELY IT'S NOT SO SIMPLE JUST HANDING OVER READING THAT PROTOCOL TO IMPLEMENT INTO YOUR LAB. SO WE ARE TRYING TO FACILITATE AND MAKE SURE THAT CAN BECOME EASIER. ONCE YOU HAVE A CELL LINE PEOPLE CAN IMPROVE ON IT, THEY WANT TO ENGINEER SOME THINGS INTO IT SO IT TURNS ON WHEN IT BECOMES A CERTAIN CELL TYPE OR MAKE IT INDUCIBLE. THINGS LIKE THAT. WE WANT TO FACILITATE SHARING OF TECHNIQUES AND TOOLS. SO CATLIZING RESEARCH, I GAVE YOU SOME EXAMPLES THERE, WE HAVE SOME PARTICULAR PROGRAMS AGI FOR REGENERATIVE RESEARCH KEEP FOCUSING ON USING STEM CELLS FOR CRIMINAL REPLACEMENT THERAPY. WE HAVE 3-D RETINAL ORGANOID CHALLENGE WHICH IS ORGANIZING 3-D RETINAL MODELS. WE ALSO I WILL SPEND TIME LATER DESCRIBING A NEW INITIATIVE CALLED AMD INTEGRATIVE BIOLOGY ISSUE, THAT'S GOING TO AGAIN LEVERAGE IPS TECHNOLOGY, TO ALLOW MODELING OF CELLULAR PHENOTYPES. AND DEVELOPING DIFFERENT ASSAYS. SO WE WILL COMMUNICATE ALL THIS INFORMATION BY A NEW WEBSITE, A MONTHLY NEWS LETTER GOING OUT BY EMAIL AND THROUGH SOCIAL MEDIA. YOU HAVE HEARD ABOUT EGI. WE ARE AT A POINT WHERE TWO CONSORTIA ARE FINISHING UP. THE FUNCTIONAL IMAGING AND REGENERATIVE FACTOR DISCOVERY CONSORTIA, SO THE PROTOCOLS AND TECHNOLOGY COMING OUT THERE NEEDS TO BE COMMUNICATED IN AND DISSEMINATE SOD THIS OFFICE IS POSITIONED TO DO THAT. THE TRANSLATIONAL ENABLING MODELS WHERE NEW USEFUL ANIMAL MODELS, WILL BE AVAILABLE TO THE VISION COMMUNITY. WILL BE COMING ONLINE IN THE NEXT COUPLE OF YEARS AND WE NEED TO THINK ABOUT HOW TO DISTRIBUTE THIS RESOURCE WHICH IS VALUABLE AND LIMITED. WE WILL LEVERAGE WHAT SHEFA TALKED ABOUT, THE STRATEGIC PLANNING SO THERE'S A REGENERATIVE MEDICINE PANEL AND WE ARE INTERESTED WHAT COMES OUT OF THOSE IN TERMS OF SUPPORTING THE COMMUNITY. A LITTLE BIT ABOUT RETINOL ORGANOID CHALLENGE, WE EXTENDED THE DEADLINE TO OCTOBER 1st OF THIS YEAR. SO IT IS WRAPPING UP, THEY ARE REQUIRED TO SUBMIT PUBLICATION QUALITY DATA THAT SHOWS THAT THESE RETINAL ORGANOIDS HAVE BEEN IMPROVED, SO THEY CAN BE USED TO MODEL DISEASE OR TO TEST DRUGS AND TOXICITIES. WE ARE EXCITED TO THINK ABOUT AGAIN HOW TO LEVERAGE THAT PROGRAM AND CARRY FORWARD SO THAT ACCESS TO THIS RESOURCE CAN BE MADE WIDELY AVAILABLE TO ACADEMICS AND INDUSTRY. AND I WOULD LIKE TO TAKE A LITTLE TIME TO DESCRIBE THIS INTEGRATED BIOLOGY INITIATIVE FIRST THE BACKGROUND IS OUR INTRAMURAL RESEARCH PROGRAM HAS INVESTED A LOT, IN DEVELOPING TECHNIQUES TO DIFFERENTIATE CELLS INTO RPE. THEY ALSO -- WE HAVE A LOT OF THE CLINICAL STUDIES, THE AGE RELATED EYE DISEASE STUDY STARTED IN THE 1990s, AND THE INTRAMURAL PROGRAM IS LEVERAGING THAT COHORT TO GENERATE IPS CELL LINES FROM CONTRACT WITH NEW YORK STEM CELL FOUNDATION, A HUNDRED PLURIPOTENT STEM CELL LINES WILL BE MADE AVAILABLE IN THE NEXT COMING YEAR. WE JUST RECEIVED THE FIRST 11 LINES FROM NEW YORK STEM CELL FOUNDATION AND THEY ARE DERIVED FROM THE 2 COHORT. SO THEY CONTAIN HIGH RISK ALLELES IDENTIFIED BY THE RESEARCH COMMUNITY TO BE USEFUL AND OF INTEREST. T THEY WILL BE AVAILABLE SOON AND WILL HAVE BOTH THROUGH THE NEW YORK STEM CELL WEBSITE AND ALSO OUR OWN WEBSITE INFORMATION ABOUT THE GENDER, SEX, STUFF LIKE THAT. CORRESPONDING TO THE PATIENTS THESE CELLS WERE DERIVED FROM. THEN THE 2 COHORT AND SELF IS GOING TO BE ALL THAT THAT DATA SET OF RICH MEDICAL HISTORY CLINICAL INFORMATION GENETIC INFORMATION IS GOING TO BE ACCESSIBLE BOTH THROUGH DB GAP, DATA PORTAL BUT A NEW ONLINE PORTAL CALLED BRICKS THAT DATA PORTAL ALLOWED THE CAPABILITY TO QUERY THE INFORMATION, TO FILTER IT FOR DIFFERENT CLINICAL PHENOTYPES OF INTEREST, SO THE IDEA IS TO BE ABLE TO CORRELATE THAT INFORMATION FROM THOSE PATIENTS WITH WHAT YOU CAN SEE IN A IN VITRO CELL LINE ASSAY. LASTLY THE NIH REGENERATIVE MEDICINE INNOVATION PROJECT, IT IS IN ITS LAST YEAR OF FUNDING. RECENTLY WAS A FUNDING OPPORTUNITY FOR CLINICAL APPLICATION CONSIST THAT WAS JUST RECENTLY REVIEWED. THERE ARE A FEW VISION RELATED APPLICATIONS AND SO WE ARE WAITING TO DISCUSS THOSE AND SEE THE SUMMARY STATEMENTS AND THINGS NEXT COUPLE OF MONTHS. IT IS A LITTLE UNIQUE PROGRAM REQUIRED MATCHING FUNDS FROM NON-FEDERAL SOURCES. AS WELL AS PARTICIPATING IN A CELL CHARACTERIZATION PROGRAM. IN WHICH THE SOURCE CELLS AS WELL AS FINAL PRODUCT TRANSPLANTED ARE REALLY ROBUSTLY CHARACTERIZED BY AN INDEPENDENT ENTITY. SO THAT WE CAN BUILD A DATABASE AND TRY TO DRAW CORRELATIONS BETWEEN THE ATTRIBUTES, QUALITIES OF THOSE STEM CELLS AND EVENTUALLY THE CLINICAL OUTCOMES THAT HOPEFULLY WILL OCCUR. THROUGHOUT THIS PIPELINE. BACK TO DISSEMINATING THIS INFORMATION AND RESOURCES. WE HAVE LIST SERVE SET UP FOR AGI AND 3-D AND WE HAVE EVEN ONE THAT COMBINES PAST PARTICIPANTS OF THE EGI WORKSHOPS AND GRANTEES, THAT'S A REGENERATIVE MEDICINE LIST SERVE, THAT'S A THOUSAND FORMER AND CURRENT GRANTEES, WE PLAN TO HOLD WEBINARS, EVEN JOURNAL CLUBS, IF THERE'S A REALLY EXCITING PUBLICATION, WHY WAIT UNTIL YOU HAVE TO SEE THEM PRESENT AT CONFERENCE OR SOMETHING LIKE THAT. YOU CAN CONVENE THEM DIRECT RELEVANCE TO THE VISION COMMUNITY ONLINE AND DISSEMINATE THOSE ADVANCES. WE WILL CONTINUE TO ORGANIZE WORK SHOTS AND SYMPOSIUM AND SEMINARS, WE ARE GOING TO TRY TO HELP PEOPLE WHEN THEY ATTEND OTHER CONFERENCES, HIGHLIGHTING SOME OF THE TALKS THAT MIGHT BE OF INTEREST THAT WE ARE SUPPORTING OR INTEREST TO RESEARCH COMMUNITY. AND WE ARE GOING TO TRY TO PROMOTE THESE PLATFORMS THAT CAN SHARE REAGENTS SO A LOT OF LABS INUNDATED WITH MATERIALS AND MATERIAL TRANSFER AGREEMENTS IMMEDIATE TO BE EXECUTED ONE WAY TO ACCELERATE THE DISSEMINA US IS DEPOSIT CELLS LINES AND TOOLS IN PLATFORMS SUCH AS ADD GENE OR CELLULAR REPOSITORY SUCH AS COREAL OR RUTGERS. THAT TAKE THAT ADMINISTRATIVE BURDEN OUT OF PEOPLE'S HANDS. TRY TO ADVERTISE AND HELP PEOPLE DO THAT WILL HELP THE COMMUNITY. SO I TALKED ABOUT RESOURCES PROVIDING RESEARCHERS BUT WE ALSO NEED TO INFORM THE PUBLIC POTENTIAL REGENERATIVE MEDICINE, THERE'S INTEREST FROM THE PATIENT ADVOCATED GROUPS. UNFORTUNATELY THERE IS A GROUP OF UNREGULATED STEM CELL CLINICS PREYING ON THE INTEREST AND HYPE OF STEM CELLS AND WE HAVE TO DIFFERENTIATE THOSE UNREGULATED STEM CELL EFFORTS WITH WHAT IS BASED AND BACKED BY SCIENCE AND NIH MONEY. SO WHEN WE HAVE STEM CELL RELEVANT TRIALS THAT ARE HAVING ENROLLMENT WE WILL PROVIDE LINKS AND ADVERTISE THOSE ARE REALLY WHAT WE ARE SUPPORTING AND WE KNOW IS VALID AND INFORM THEM ABOUT THE ISSUES AND INFORMED CONSENT AND PROVIDE LOT OF RESOURCES THAT THE INTERNATIONAL STEM CELLS RESEARCH SOCIETY ISSCR HAS COUPLE OF GUYS AND THINGS LIKE THAT TO EDUCATE PATIENTS BE AWARE OF DIFFERENCES. WE HAVE AN EMAIL BOX YOU CAN CONTACT US. I WANTED TO ACKNOWLEDGE SOME OF THE UPCOMING ACTIVITIES NEXT WEEK AT THE WORLD STEM CELL CENTER. PRESENTING A POSTER ABOUT THE NEW OFFICE. WE WILL BE HAVING A WEBINAR FOR 3-D ROCK SPONSORS TO ADVERTISE RESOURCES YOU CAN BRING TO PARTICIPANT IN THAT PROGRAM. WE WILL BE AT THE NEI BOOTH AND STANDING UP AN NIH BOOTH AT ISSCR. TO DELVE INTO ACTIVITYS FROM AGI COMING UP, THANK YOU FOR THE WORKSHOP CLEARANCES, THAT YOU APPROVED LAST TIME, WE MET. THE WORKSHOP ON UNDERSTANDING HUMAN RETINAL BIOLOGY AND PERCEPTION WILL BE HELD IN COUPLE OF WEEKS. APOLLO, WE HAVE 22 ADDITIONAL INVESTIGATORS JOINING THAT MEETING TO AGAIN DISCUSS ISSUES AND OPPORTUNITIES THAT CAN IMPACT REGENERATIVE MEDICINE AND WE'LL HAVE A SUMMARY PUBLISHED IN ACADEMIC JOURNAL. WE HAVE TWO PI MEETINGS COMING UP. ONE FOR THE TRANSLATIONAL MODEL CONSORTIUM WHICH WILL BE SECOND AFTER INITIAL KICK OFF THIS PAST YEAR. THEN THE FINAL PI MEETING FOR THE IMAGING CONSORTIUM AFTER FIVE YEARS FUNDING WE WILL HEAR ABOUT WHERE THEY HAVE ADVANCED THEIR PROJECTS. ALSO THE TOPIC OF THE IMMUNOLOGY SURROUNDING RETINAL TISSUE AND CELLS, WE DECIDED TO FORM INTO A TOWN HALL SO WE ARE STILL FIGURING THE DETAILS AND RECRUITING PARTICIPATS BUT WE ARE EXCITE TO HAVE A VISION COMMUNITY AT LARGE WEIGH IN AND HELP US UNDERSTAND THE ISSUES ON THAT TOPIC. THEN WE WANT TO LOOK FORWARD AND DISSEMINATE A LOT OF TECHNOLOGIES METHODOLOGIES COMING OUT OF GRANTEES AND IN A GRANT PORTFOLIO OF AGI RELEVANT PROJECTS WE HAVE IDENTIFIED OVER A HUNDRED PIs AND OVER 150 PROJECTS, THEY HAVE AN IMPACT AND RELEVANCE TO WHAT WE ARE TRYING TO DO WITH AGI AND WE NEED TO PROVIDE SOME SORTS OF FORUMS TO GET THAT INFORMATION OUT THERE, WE ARE THINKING SYMPOSIUM WHERE WE CAN CAPTURE THAT AND DISSEMINATE IT TO THE COMMUNITY. PLEASE REACH OUT TO US. I'LL ANSWER QUESTIONS NOW, I WANT TO ACKNOWLEDGE AMBER REED WHO YOU HEARD ABOUT IS JOINED THE OFFICE AND YOU WILL BE HEARING FROM AND PROVIDING A LOT OF SUPPORT TO THIS OFFICE. THANKS SO MUCH. [APPLAUSE] >> I GUESS OF COURSE THIS IS THE PREROGATIVE OF NEI HOW APARTMENT TO EMPHASIZE THINGS. IN TERMS OF REGENERATIVE MEDICINE WITH CELLS, STEM CELLS ARE ONE WAY OF DOING REGENERATIVE MEDICINE WITH CELLS. BUT ANOTHER WAY OF DOING REGION REGENERATIVE MEDICINE IS TRANSDIFFERENTIATION WITH CELLS. I'M SURE YOU MUST HAVE THOUGHT ABOUT THAT BUT PRETTY GOOD EVIDENCE MUELLER CELLS UNDER THE RIGHT CIRCUMSTANCES TO DIFFERENTIATE WITH PHOTO RECEPTOR,NATIVE PHOTO RECEPTORS WHICH OVERIATES THE NEED TO DISCUSS IMMUNOTHERAPY AND PROCESS FOR CONTROL SYNAPSE FORMATION. IS THAT -- DO YOU INTEND EVER TO BRING THAT INTO FOCUS OR IS THAT NOT GOING TO BE PART? >> ORIGINALLY THAT WAS PART OF THE SCOPE AND WE HAD A DISCUSSION ON THE CONTRIBUTIONS OF MUELLER GLIA IN A WORKSHOP COUPLE OF YEARS AGO. IT WAS AFTER THAT WORKSHOP IT WAS KIND OF THOUGHT THE FIELD ALTHOUGH ADVANCING IN VERY -- HAS THE GREAT POTENTIAL AND HAS THE ADVANTAGES THAT YOU DESCRIBE, IT'S JUST NOT THERE FOR IMMEDIATE TRANSLATION LET'S SAY. BUT WE ARE NOT KEEPING OUR EYE OFF THAT POSSIBILITY. WE ARE BRINGING INTO THE REGENERATIVE MEDICINE PANELS AND OTHER DISCUSSIONS THAT THOSE EXPERTS AND THAT EXPERTISE WE HAD LAST FALL TALKING ABOUT ADVANCING CELLULAR THERAPIES. INTO THE CLINIC. WE HAD RECENT ADVANCES BY GROUPS AT YALE AND TOM WRIGHT AND THINGS LIKE THAT WHO CAN WEIGH IN ON THE PROMISE AND DIFFICULTIES AND HURDLES THAT ARE SEPARATE AND PERTAIN TO THAT APPROACH FOR ENDOGENOUS. BUT CERTAINLY, LEVERAGING ENDOGENOUS CAPACITY REACTIVATING THAT, THINGS LIKE THAT, ARE DISCOVERY CONSORTIUM INITIATIVE IS PURSUING THAT AND WILL HAVE A DATABASE OF COMPARING THOSE SIGNALING PATHWAYS AND FACTORS THAT ACTIVATE IN ZEBRAFISH AND CHICK THAT PERHAPS WE CAN TWEAK FOR HUMANS. >> I'M SURE IT'S NOT JUST PHOTO RECEPTORS BUT THE NEW YORK STEM CELL FOUNDATION HAS A TECHNOLOGY TO DO THE SAME THING WITH RPG CELLS TO ACTIVATE WHAT APPEAR TO BE A CELL GROUP THAT PRODUCES RP CELLS, ENDOGENOUS STEM CELLS, SAL HI TEMPLE AND JEFF STERN IS FUNDED BY NIH REGENERATIVE MEDICINE PROJECTS. THAT IS ADVANCING. >> SECOND THAT IN TERMS OF NOT LOSING FOCUS ON THE BASIC BIOLOGY THAT WE LEARNED FROM MODEL ORGANISMS WE GENERATE SUCH REPROGRAMMING. USING THE BASIC MODEL ORGANISM IS SEMINOT TO FORGET. THE INITIATIVE COMPARATIVE OF OMICS IS IMPORTANT BUT I THINK NOT LOSING EYE ON THE BASIC MODEL ORGANISMS WITH THE SUPERVISION (INAUDIBLE) RPE. >> ABSOLUTELY. I THINK FINDING THAT BALANCE OF CARRYING TRANSLATION THROUGH BUT ALSO FOCUSING ON GAPS AND BARRIERS AND THAT BASIC BIOLOGY THAT WE STILL NEED TO CODE AND LEVERAGE IS SOMETHING OUR STEERING COMMITTEE, WE HAVE ASKED THEM TO HELP US UNDERSTAND THAT. AND ALSO THROUGH THE REGENERATIVE MEDICINE PANELS, HOPEFULLY YOU WILL PARTICIPATE IN WILL COME THROUGH SO THAT WE CAN KNOW WHERE AND HOW TO INCORPORATE THAT INFORMATION. >> THANK YOU, STEVE. I WONDERED IF YOU HAVE IS THERE A PLACE PATIENTS GO TO GET INFORMATION ABOUT EXISTING CLINICAL TRIALS NOW? POTENTIALLY COULD BE LINKED TO OUR OWN UNIVERSITY WEBSITE? >> THERE IS CLINICALTRIALS.GOV. AND I THINK WE HAVE HAD A DISCUSSION ON HOW TO IMPROVE THAT. AND THINGS LIKE THAT SO I THINK IT MIGHT BE UNDERGOING A RENOVATION PROCESS, IF THERE IS A BANNER THERE BUT THAT'S A GOOD START. I KNOW A LOT OF ACADEMIC UNIVERSITIES LINKED TO. >> THANK YOU, STEVE. OPERATIONALLY OR PRACTICALLY HOW DO YOU ENVISION SHARING TO TAKE PLACE? IS THERE A WEBSITE WHERE PEOPLE CAN EITHER ASK FOR OR POST AVAILABILITY OF PROTOCOLS? THIS IS DONE BY EMAIL AND O LOOSE SYSTEMS NOW. SHARING THE REAGENTS AND CELLS. HOW DO YOU ENVISION IT WORKING? OR DO YOU HAVE TO APPLY? >> THANK YOU FOR THAT QUESTION. WE PUT IN SOME THOUGHT INTO THAT. ONE IS LIKE YOU SAID HOSTING SOME PROTOCOLS ON LION THAT HAVE BEEN WELL ESTABLISHED AND EMBRACED BY THE COMMUNITY. THAT'S ONE APPROACH. ANOTHER ONE WOULD BE TO REALLY HIGHLIGHT THEM IN A WEBINAR SOMETHING LIKE THAT. THERE IS A PAPER THAT COME OUT TO EXPLAIN THE NUANCES THAT WERE INCLUDED OR EMBEDDED IN SUPPLEMENTAL INFORMATION. WE HAVE TRIED, THERE WAS AN AGI DISCUSSION FORUM WE WERE HOPING TO ALLOW THE POSTING AND DISCUSSION ABOUT THESE PROTOCOLS AND ADVANCES, THINGS LIKE THAT. THAT WAS NOT EMBRACE BY THE COMMUNITY, IT WAS ANOTHER SITE THEY HAD TO REMEMBER AND NEEDED TO INTERACT WITH. BUT TURNS OUT THAT THAT CONCEPT OF SHARING INFORMATION IS REALLY CRITICAL FOR OUR CONSORTIUM THEMSELVES. NEXT WEEK WE WILL HAVE DEMONSTRATION OF TOOLS, COLLABORATION TOOLS, BOTH EMBEDED FROM COMMERCIAL VENDORS AS WELL AS CUSTOM MADE THAT ALLOW CONTROLLED ENVIRONMENT FOR COLLABORATORS FIRST TO SHARE PROTOCOLS AND SHARE DATA IMAGES IN MORE OR RESEES REAL TIME NOT BY EMAIL OR BEING ABLE TO TAG AND CATEGORIZE AND HAVE DISCUSSIONS ON PARTICULAR TOPICS TO PROMOTE COLLABORATION AND OVERCOMING OF THESE DIFFICULTIES THAT WILL BE ELUCIDATE IN THE TRANSLATIONAL MODELS. THEY WILL DEVELOP ANIMAL MODELS FOR INSTRUMENTATION AND TECHNIQUES AN THINGS LIKES THAT. SO THERE'S DISCUSSION THREADS, IF THAT WORKS IN CONFINED CONSORTIA, THE IDEA IS HOW DO WE GET THAT INFORMATION DEVELOP A PROCESS AS SOON AS THERE'S PUBLICATION. SO FOR EXAMPLE, THE DISCOVERY FACTORS REGENERATIVE CONSORTIA, USING SAINT JUDE'S PORTAL TO HOUSE INFORMATION AND BE ABLE TO LOOK AT IT INTERNALLY. BUT THERE IS A SWITCH THAT MAKES THAT INFORMATION AVAILABLE PUBLICLY. THAT'S GOING TO BE DESCRIBED HOPEFULLY IN SOME UPCOMING MEETINGS. WE ARE HOPING FOR ACCEPTANCE AT COUPLE OF CONFERENCES BUT IF NOT, WE WILL DO OUR OWN AND ADVERTISE RESASHESES IN THAT COLLABORATION. THANK YOU VERY MUCH. [APPLAUSE] >> OUR LAST SPEAKER BEFORE THE MORNING BREAK WILL BE DR. BRUCE REED. BRUCE IS DEPUTY DIRECTOR AT THE CENTER FOR SCIENTIFIC REVIEW AND HE'S GOING TO BE TALKING ABOUT THEIR INQUIRE PROCESS EVALUATING PANEL QUALITY AND REVIEW. GROUP 11, FUNCTIONAL NEUROSCIENCE WENT THROUGH THAT PROCESS AND IS STILL GOING THROUGH THAT PROCESS. GROUP 11 INCLUDES VISION CENTRIC STUDY SECTIONS BVS DPVS CPSBC AND HANDLES CORNEA AND OTHER ANTERIOR SEGMENT AREAS OF SCIENCE. THANK YOU, BRUCE. >> GOOD MORNING. AT YOUR LAST MEETING YOU HEARD ABOUT CSR PLANS FOR STUDY SECTION BVS DPVS AND SPECIAL EMPHASIS PANEL BDCN J 8 1, OCULAR SURFACE ANTERIOR (INAUDIBLE). THOSE PLANNED RAISED CONCERN WITH COUNCIL, I SAW YOUR LETTER SO HAPPY TO BE HERE TO TRY TO ADDRESS SOME OF YOUR CONCERNS. I WOULD LIKE TO GIVE A BETTER UNDERSTANDING OF THE PROCESSES ABOUT THE STRUCTURE OF OUR STUDY SECTION. SO TO GIVE YOU THAT UNDERSTANDING, NEED TOE TALK ABOUT INQUIRE. THAT'S THE TORTURED ACRONYM THAT WE USE THERE WERE WORSE CHOICES P. HERE IS THE PROBLEM. SCIENCE EVOLVES. HOW DOES CSR KEEP STUDY SECTIONS ALIGNED WITH THE SCIENCE AND KEEP THEM FUNCTIONING OPTIMALLY IN TERMS OF IDENTIFYING STRONGEST SCIENCE? WE NEED A PROCESS, THIS IS A FUNDAMENTAL PROBLEM WE DEALT WITH OVER THE YEARS. I WANT TO WALK YOU THROUGH THIS QUICKLY. SO FOR MANY YEARS WE ADDRESS THIS PROBLEM BY INTERNALLY ORIENTED REVIEWS SO OUR STUDY SECTIONS ARE ORGANIZED INTO INTEGRATED REVIEW GROUPS, THESE ARE ADMINISTRATIVE UNITS, THAT CLUSTER TOGETHER SCIENTIFICALLY RELATED STUDY SECTIONS, WE FOR MANY USERS WOULD REVIEW IRG. FIRST THIS WAS AN ENTIRELY INTERNAL PROCESS SO SENIOR MANAGEMENT, LOOKED AT THESE AND HOW THEY WERE FUNCTIONING. OVER THE YEARS WE BROADENED THIS PROCESS OUT BY BRINGING IN STUDY SECTION CHAIRINGS AND SELECTED REVIEWERS. AND EVENTUALLY BROADER EXTERNAL BLUE RIBBON WORKING GROUPS TO EVALUATE SETS OF STUDY SECTIONS. WE DID NOT FIND THIS TO BE AN ENTIRELY SATISFACTORY PROCESS. PRIMARILY BECAUSE WE WERE NOT GETTING MANY CHANGES WITH THE SCIENTIFIC STRUCTURE OF THE STUDY SECTIONS. WE GOT A LOT OF COMMENTS ABOUT PROCESS. SO HOW WERE THE STUDY SECTIONS WORKING. HOW SROs ARE. O PERFORMING THAT KIND OF THING BUT THE ONLY SCIENTIFIC CHANGES WE GOT WERE INTERNALLY GENERATED BY CSR. IF THE CHIEF CAME SAYING I THINK I NEED A NEW STUDY SECTION TO COVER X, THAT WOULD GENERALLY GO FORWARD BUT NOTHING WAS COMING FROM THE EXTERNAL FOLKS AND WE THOUGHT THE PROCESS WAS INSULAR AND NEEDED TO BE BROADENED OUT. SO WE DID THAT IN OUR NEXT ITERATION, SRG REVIEW SO SRG IS SCIENTIFIC REVIEW GROUP. STUDY SECTION. THERE WERE TWO KEY CHANGES HERE INSTEAD OF ORGANIZING THE CLUSTERS OF THE STUDY SECTIONS BY OUR OWN ADMINISTRATIVE UNITS, WE DID BY SOME SCIENTIFIC CLUSTER EGG. BIOMEDICAL ENGINEERING, DEVELOPMENTAL IMAGING SCIENCE THOSE KIND OF THINGS. WE SUBMITTED THESE PANELS TO BLUE RIBBON EXTERNAL PANELS SO PROMINENT SCIENTISTS IN THE FIELD. WE ASKED A SINGLE QUESTION TRYING TO GET THEM AWAY FROM THE PROCESS ORIENTED STUFF, ASK THEM HOW WELL DOES THE SCIENTIFIC SCOPE OF THE STUDY SECTIONS ALIGN WITH THE CURRENT STATE OF SCIENCE. WE INDEED BEGAN TO GET MORE CHANGES EXTERNALLY GENERATED CHANGES WITH THAT PROCESS. MEANWHILE AT NIH THERE WERE OTHER DISCUSSIONS THAT REALLY BEGAN TO FOCUS ON THE FACT THAT THERE ARE TWO DIFFERENT REASONS STUDY SECTIONS CAN MAKE MISTAKES. BY THAT I MEAN TWO REASONS STUDY SECTIONS FAIL TO IDENTIFY THE BEST SCIENCE. ON YOUR LEFT, TWO EXAMPLES. YOU HAVE GOT STUDY SECTION A, THEY ARE DOING A GREAT JOB. THE END OF THE DAY WHEN THEY RANK EVERYTHING, WORST ON BOTTOM BEST ON TOP, YOU HAVE YOUR NOT SO GOOD APPLICATIONS CLUSTERED AT THE BOTTOM, YOU HAVE HIGH QUALITY AT THE TOP, THOSE ARE THE ONES THAT GO FORWARD FOR X ITERATION. STUDY SECTION B ON THE OTHER HAND IS CLUELESS, THEY HAVE DONE ALL THEIR REVIEWS AND YOU HAVE GOT GOOD APPLICATIONS MIXED WITH BAD AND SOME OF THE WEAKER APPLICATIONS -- THAT'S ONE PROBLEM. YOU CAN ALSO GET INTO A PROBLEM STRUCTURING SCIENCE WITHIN STUDY SECTIONS. ON THE RIGHT HAND YOU SEE TWO CONTRASTING SITUATIONS, STUDY SECTION A WAS A HOT AREA OF SCIENCE, REALLY STRONG REALLY HIGH IMPACT SCIENCE, ALL CLUSTERED IN ONE STUDY SECTION. EACH STUDY SECTION FORMS ITS OWN COMPETITIVE POOL. THERE'S ONLY A FIXED NUMBER OF TOPPERS TILE APPLICATIONS THAT COME OUT OF IT, NO MATTER WHAT. YOU HAVE ALL THESE STRONG APPLICATIONS, ONLY A STRONG PORTION GOING FORWARD. STUDY SECTION B THIS IS WEAKER, MAYBE UPDATED SCIENCE, YOU HAVE WEAKER APPLICATIONS, DOESN'T MATTER. STILL PORTION OF THOSE ARE GOING FORWARD SO YOU ARE AGAIN FAILING TO IDENTIFY ONES THAT YOU WANT. NIH IS CONCERNED ABOUT THE LATTER KIND OF IMBALANCE AND SAID TO US YOU HAVE GOT TO DO SOMETHING ABOUT THAT, THE NIH CONVENED A TRANS-NIH WORK GROUP TO CREATE PROCESSES FOR EVALUATING STUDY SECTIONS, TO IDENTIFY -- TO DEAL WITH BOTH OF THESE PROBLEMS. IT WAS OUT OF THAT EAWG WORK GROUP THAT THE PROCESS AROSE. THAT WAS THE GROUP THAT CREATED THE ENQR PROCESS AND SAID TO CSR THIS IS WHAT WE WOULD LIKE YOU TO IMPLEMENT SO THAT'S WHAT WE ARE DOING. TO SHOW HOW THE TRANSITION OCCURRED WE ARE DOING THE REVIEWS BIOREPRESENTATION ENGINEERING AND SO FORTH, THE VISUAL SCIENCES ONE WHICH HAPPENED IN SEPTEMBER OF 2018. WHICH MARY ANN SERVED ON, IT SEEMS TO ME RAN FROM GW TO BE THERE. THANK YOU. WAS THE LAST OF THESE. CONCURRENTLY WITH THAT, THE PROCESS WAS STARTING SO THE FIRST ENQR REVIEWS WERE STARTING JUST AS THE LAST SRG REVIEW WAS UNFOLDING. NOW WE HAVE RUN A NUMBER OF THOSE DUSTER 11, FUNCTIONAL NEUROSCIENCE, INCLUDED THE ONES OF INTEREST. WHAT HAPPENED HERE? THE AT THE MARCH -- NOT 2018, THAT'S 2019, THAT SHOULD BE. SO WE HAD THE S ARE,G REVIEW IN SEPTEMBER OF '18. THAT GROUP MADE A NUMBER OF RECOMMENDATIONS BUT BASICALLY LIKE THE EXISTING STRUCTURE OF THE STUDY SECTIONS. THEY SAY KEEP BASIC BIOLOGY ONE, KEEP A DISORDERS AND PATHOPHYSIOLOGY ONE THAT WAS ORIENTED ON BACK OF THE EYE AND CREATE A GO AHEAD AND CHARTER THE G 81 WHICH SAME TOPICS FOR THE OCULAR SURFACE ANTERIOR SEGMENT. SO WE TOOK THAT TO OUR COUNCIL. NOTING THE COMMITTEE RECOMMENDATION, COUNCIL DID NOT CONCUR WITH THAT RECOMMENDATION. COUNCIL NOTED. CONCERNS OF NARROWNESS WITH SCIENCE WITHIN OCULAR SURFACE AND NOTED SPECIFICALLY THE ENQR PROCESS STARTED UP AND SAID TO US OKAY, PLEASE PUT THESE STUDY SECTIONS BACK INTO ENQR PROCESS AND COME BACK TO US. SO THAT MADE MY SUMMER PRETTY BUSY. THIS IS THE PROCESS ENQR GOES THROUGH. BASE SISSY POINT HERE, THIS TAKES IN TO ACCOUNT THE POINTS OF VIEW OF MULTIPLE STAKEHOLDERS SO IT STARTS WITH A EXTERNAL ADVISORY PANEL, TAKES RECOMMENDATIONS OF THAT PANEL, GOES TO A TRANS-NIH INTERNAL PANEL AND THEN GOES BACK TO CSR COUNCIL. BULLET ME WALK YOU THROUGH IN LITTLE MORE DETAIL WHAT HAPPENED IN CLUSTER 11. THE TASK OF THE EXTERNAL PANEL IS TO LOOK AT THE SCIENCE AND TO RECOMMEND APPROPRIATE BOUNDARIES FOR THE TOPICS. WE GIVE THEM A LOT OF INFORMATION. WE GIVE TO HELP THEM GRASP WHAT THE RANGE OF SCIENCE IS. THEY LOOK AT STUDY SECTION SUBSCRIPTIONS, RANDOM SAMPLE OF APPLICATIONS, THEY GET OUTPUT MEASURES. WE WANT THEM TO FOCUS ON THIS PARTICULAR QUESTION IS THE SCIENTIFIC SCOPE OF EACH PANEL APPROPRIATE TO SUPPORT THE IDENTIFICATION OF HIGH QUALITY RESEARCH. THESE ARE STUDY SECTIONS THAT WENT INTO CLUSTER 11 SO THE EYE ONES, THESE ARE THE NEURAL BASIS OF FUNDAMENTAL SENSORY PERCEPTION COGNITIVE PROCESSES. THIS WAS THE ROSTER, THE POINT I WOULD MAKE SHEER IS THERE WAS A NUMBER OF PEOPLE WHO HAVE SUBSTANTIAL EXPERTISE IN THE BIOLOGY OF THE EYE, DISORDERS IN PATHOPHYSIOLOGY OF THE EYE WHO SERVED ON MULTIPLE STUDY SECTIONS. OF INTEREST HERE. SO WHEN THIS COMMITTEE MET, THIS IS HOW I ASKED THEM TO FRAME THE TASK. START WITH A BRAINING SLATE. WE GIVE YOU BIG RANGE OF SCIENCE COVERED BY IS THE STUDY SECTIONS. WHAT ARE THE BEST SET OF STUDY SECTIONS TO REVIEW THIS SCIENCE? THEY NEEDED TO THINK ABOUT WHAT MAKES FOR GOOD STUDY SECTION. THERE'S TWO COMPETING CONSIDERATIONS HERE. SO ONE IS THAT YOU NEED A BALANCED COMPETITIVE POOL. THIS CONSIDERATION I THINK TENDS TO MAKE STUDY SECTIONS BROAD BECAUSE YOU CAN'T JUDGE THE RELATIVE IMPORTANCE OF THINGS WITHIN A VERY NARROW TOPICAL AREA. YOU NEED TO INCLUDE CONTRASTING TOPICS RANGES AND MODEL AND DIFFERENCE FIELDS TO JUDGE COMPARATIVE MERITS. ON THE OTHER HAND, PEOPLE ON STUDY SECTION NEED TO TALK TO EACH OTHER. NEEDS TO BE INFORMATIVE. THEY NEED TO INTERPRET THE DIFFERENCES BETWEEN THE DIFFERENT KINDS OF STUDIES. THIS IS A NARROWING CONSIDERATION. WE HAVE TO GET THE RIGHT BALANCE WITH STUDY SECTION BOUNDARIES AND WORKLOADS NEED TO BE MANAGEABLE BUT DON'T PAY TOO MUCH ATTENTION TO THAT. WE'LL DEAL WITH IT. THE OTHER THING I WANT TO EMPHASIZE IS WE GAVE THE -- I KNOW YOU ARE CONCERNED ABOUT COUNCIL OUR COUNCIL PERCEPTION SCIENCE WAS NARROW, WE GO TO A LOT OF EFFORT TO INFORM THESE PANELISTS ABOUT THE RANGE OF SCIENCE IN EACH STUDY SECTION SO TAKING G 81 AS AN EXAMPLE, THEY GET THE DESCRIPTION, THEY GET HIGH LEVEL DESCRIPTION, TOPICS, OVERLAPS, OTHER STUDY SECTIONS. THEY GET A SAMPLE OF APPLICATION S, WE CHOSE THESE RANDOMLY BUT WE ALSO WENT BACK TO CHIEFS AND SRO AND SAID HEY DID THE RANDOM SAMPLE MISS ANYTHING? DID IT GROSSLY OVERREPRESENT ANYTHING WE WANTED TO REALLY REPRESENT THE SCIENCE OF THIS PANEL. WE ALSO GAVE THEM THIS WORD PIE CHART WHICH CRUDE LEVEL GIVES YOU THE RANGE AND DISTRIBUTION OF TOPICS WITHIN THE STUDY SECTION. ANOTHER EFFORT TO GET THEM TO UNDERSTAND WHAT THE RANGE OF SCIENCE WAS. THE CLUSTER OF PANEL THOUGHT ABOUT THE ISSUE OF WHAT WAS AN APPROPRIATE COMPETITIVE FIELD, THERE WAS OBVIOUSLY ON THEIR MIND IN THEIR DISCUSSIONS. THEY WERE CONCERNED WHERE EMERGING SCIENCE WOULD BE COMING FROM, CONCERNED HOW DO YOU ATTRACT YOUNG SCIENTISTS, HOW DO YOU ATTRACT CUTTING EDGE WORK TO THESE STUDY SECTIONS TO KEEP THEM VITAL? THEY ABSOLUTELY CONSIDER A VARIETY OF ALTERNATIVE ORGANIZATIONAL STRUCTURES FOR STUDY SECTION. NOT JUST FOR THE ONES OF INTEREST TO YOU BUT THE WHOLE CLUSTER 11. END OF THE DAY THESE WERE RECOMMENDATIONS THEY RECOMMENDED MAJOR CHANGES FOR FOUR STUDY SECTIONS, WITH THREE EYE PANELS WE MENTIONED AND THEN NNRS NNRS NEURAL ENDOCRINOLOGY, NEURAL IMMUNOLOGY, CIRCADIAN RHYTHMS AND SLEEP. THEY THOUGHT THAT WAS TOO BROAD. SO -- OKAY. THIS IS WHAT I JUST TOLD YOU. THIS IS WHAT THEY RECOMMENDED WITH RESPECT TO EYE PANEL. SO THEIR RECOMMENDATION WAS THEY THAT YOU GO WITH A BASIC EYE BIOLOGY AND YOU PUT POSTERIOR ANTERIOR PATHOPHYSIOLOGY DISEASE STUFF IN ONE STUDY SECTION BUT THAT'S TOO BIG SO SPLIT IT, MAKE IT INTO TWIN STUDY SECTIONS AND COVER IT THAT WAY. THAT WAS THE RECOMMENDATION THE INTERNAL PANEL WAS ASKED TO CONSIDER. WE DID GIVE INTERNAL PANEL SOME ADDITIONAL INFORMATION, NOT GOING TO -- IT WAS PROCESS ORIENTED, I HI FOR TODAY'S PURPOSES WE WILL PUT THAT ASIDE. WE DID ASK THE INTERNAL PANEL WHAT DO YOU THINK OF THE RECOMMENDATIONS FROM THE EXTERNAL PANEL? MIKE STEINMETS WAS ON THAT COMMITTEE AND REPRESENTED I THINK YOUR POINT OF VIEW STRONGLY. SO THIS WAS THE OUTCOME FROM THE INTERNAL PANEL, THE INTERNAL PANEL DID NOT AGREE WITH THE EXTERNAL WITH RESPECT TO THE REORGANIZATION BUT RATHER PROPOSE ORGANIZATIONAL STRUCTURE SIMILAR TO YOU OUTLINE IN THE LETTER. HAY DIDN'T LIKE NARROWING OF NNRS. THE OTHERS WE CAN SKIP FOR PRESENT PURPOSES. SO CSR WE HAD SITUATION WHERE OUR EXTERNAL PANEL SAID ONE THING, INTERNAL PANEL SAID ANOTHER, SO WE BROUGHT THIS TO OUR ADVISORY COUNCIL AND SAID WHAT DO YOU THINK? OUR ADVISORY COUNCIL SAID WE LIKE THE BROADER STUDY SECTIONS, THAT'S WHAT WE LIKE YOU TO DO. SO THAT'S WHAT WE ARE WORKING ON. SO COUPLE OF THINGS MOVING FORWARD. WE ARE WORKING TO IMPLEMENT THAT STRUCTURE RECOMMENDED BY OUR ADVISORY PANEL. WE SHARE THE SAME. YOUR NEI COUNCIL AND CSR SHARE SAME GOAL. WE WANT TO GET -- WE WANT YOU TO FUNCTION TO IDENTIFY THE BEST SCIENCE. WE LIKE TO WORK WITH YOU ON THAT. EVALUATION OF STUDY SECTIONS IS AN ONGOING PROCESS. SO THE ENQR PROCESS IS STRUCTURED SO EVERY STUDY SECTION UNDERGOES REVIEW EVERY FIVE YEARS BUT I WANT TO EMPHASIZE TO YOU THAT WE DON'T WAIT FIVE YEARS TO LOOK AT STUDY SECTIONS. WE DON'T WAIT FIVE YEARS TO FIX PROBLEMS. WE LOOK AT STUDY SECTIONS EVERY ROUND. EVERY ROUND CHIEF VISITING MEETINGS, SROs SHOULD BE LOOKING AT THEIR MEETINGS AND USUALLY ARE. DIVISION DIRECTORS ARE GOING. NEW PANELS CREATED UNDER EMQR PROCESS ARE INTENSE INTEREST TO CSR. THERE'S QUITE A FEW NEW PANELS BEING FORMED UNDER THIS PROCESS. I TRIED TO DO QUICK COUNT, SEEM TO ME THERE'S AT LEAST 20 NEW ONES COMING OUT FROM THE FOUR REVIEWS RUN SO FAR. WE WANT TO KNOW HOW THOSE ARE WORKING SO WE WILL BE LOOKING. IF WE SEE THINGS THAT NEED TO BE FIXED, WE WILL ADDRESS THOSE. REGARDING THE MANAGEMENT OF TWIN STUDY SECTIONS. TWIN STUDY SECTIONS IS NOT THE EASIEST. IT DOES REQUIRE ACTIVE MANAGEMENT. YOU CAN'T JUST RANDOMLY ASSIGN APPLICATIONS BETWEEN THEM. THE CHIEF AND THERE WILL BE A SINGLE CHIEF HANDLING THIS REFERRAL, NEEDS TO DO IN PA THOUGHTFUL WAY, YOU NEED TO BALANCE THEM SO THEY ARE DISTRIBUTED REASONABLY EVENLY ACROSS STUDY SECTIONS IS QUITE LIKELY THAT THEY ARE NOT IDENTICAL TWINS. YOU WILL HAVE DIFFERENT PEOPLE ON THE PANEL, DIFFERENT AREAS OF EXPERTISE. TYPICALLY YOU SEE SOME EVOLUTION OF EXACTLY WHAT THESE TWO PANELS COVER, WE BROADLY SIMILAR BUT YOU DO HAVE TO PAY ATTENTION TO THOSE DIFFERENCES, THE CHIEF IS GOING TO HAVE TO MANAGE THAT. MEMBERSHIP ON THE TWO PANELS IS GOING TO HAVE HAVE TO BE MANAGED CAREFULLY. IT TAKES APPROPRIATE TRAINING AND MANAGEMENT. NOT JUST WITH THESE PANEL BUS YOU WILL OUR PANELS. WE NEED TO GET REVIEWERS TO BE ENGAGED, WE WANT THE WHOLE PANELS TO BE CONSIDERING ALL THE APPLICATIONS AND WE WANT TO BE DISCOURAGING CAMPS OF SEPARATE REVIEW -- SEPARATE SUBGROUPS COMPETING WITH EACH OTHER WITHIN THE STUDY SECTION. I WOULD POINT OUT THERE'S SOME ADVANTAGES TO TWIN STUDY SECTIONS WE SOMETIMES HEAR FROM REVIEWERS WHO ARE RELUCTANT TO SERVE ON STANDING STUDY SECTIONS BECAUSE THEY KNOW THEIR APPLICATIONS ARE THEN GOING TO TO A MEMBER CONFLICT SO PEOPLE DON'T LIKE MEMBER CON -- THIS FIXES THIS PROBLEM. FINALLY I WOULD SAY CSR LIKE YOUR HELP IN MAKING THIS WORK. WHAT CAN YOU DO. SUGGEST APPROPRIATE REVIEWERS, WE ARE SHORTLY GOING TO HAVE PORTAL THAT WILL MAKE IT MUCH EASIER FOR ICs AND FOR PROFESSIONAL SCIENTIFIC SOCIETIES TO SUGGEST TO US REVIEWERS FOR STUDY SECTIONS. I WOULD ASK YOU GIVE THIS STRUCTURE A FAIR CHANCE. IF DPVSA AND WHATEVER THIS ITERATION IS MANY THE 2021 JANUARY COUNCIL,, HAS 30 CORNEA APPLICATIONS, AND ONLY TEN GET DISCUSSED, DON'T PANIC. IF YOU HAVE A FAIR COIN AND FLIP 30 TIMES IT'S NOT THAT UNCOMMON TO HAVE TEN COME UP HEADS. THAT HAPPENS. WE WILL BE WATCHING. WE WILL BE LOOKING AT THE STRUCTURE OF WHAT GETS DISCUSSED WE WILL BE LOOKING AT THE QUALITY OF DISCUSSIONS WITHIN THESE. AND THE QUALITY OF INTERACTIONS ON THESE PANELS. FINALLY, PLEASE KEEP US INFORMED. WE WANT TO HEAR FROM THE VARIOUS PEOPLE WE SERVE. SEEMS I DON'T HAVE TO ENCOURAGE YOU TO REACH OUT TO US. PLEASE DO. HAPPY TO TAKE YOUR QUESTIONS. >> MY QUESTION I GUESS COULD BE SUMMARIZED BY THE QUESTION OF WHAT IS GROUND TRUTH. IT HAS FOUR PARTS TO IT. SO THE IDEA OF GOOD SCIENCE VERSUS BAD SCIENCE. LOGIC WORKS IN THE OPPOSITE DIRECTION OF TIME. YOU ESTABLISH CAUSALITY BY LOOKING BACK IN TIME. GOOD SCIENCE VERSUS BAD SCIENCE IS A GOOD EXAMPLE OF THAT. YOU DON'T KNOW WHAT GOOD SCIENCE IS UNTIL TIME PASSED. IF I WERE TO SAY WHAT HAS THE STUDY SECTION UNDER CURRENT CONFIGURATION CONTRIBUTED TO SCIENCE, JUST SCIENCE, NEUROSCIENCE, IT'S ENORMOUS. ALL THE BASIC MECHANISMS OF SECOND MESSENGER SIGNAL WORK OUT IN THESE STUDY SECTIONS. SO I HAVE TO SAY CURRENT STRUCTURE ACTUALLY HAS PRODUCED INCREDIBLE GOOD SCIENCE. HOW YOU JUDGE THAT GOING FORWARD IS CONCERN BECAUSE OF THE LOGICAL PROBLEM I POSED TO YOU. THEREFORE HOW DO YOU JUDGE WHETHER IT'S WORKING OR NOT IS NOT CLEAR TO ME. A SECOND RELATED ISSUE, THE RANGE OF EXPERTISE, WHEN I LOOKED, I'M NOT FAMILIAR WITH ALL THE SCIENTISTS WHO WERE IN THOSE SECTIONS. SO I'M A LITTLE BIT AT A DISADVANTAGE IN SAYING THIS. I CAN TELL YOU IT'S PRETTY UNLIKELY THAT FIVE OR FOUR PEOPLE WOULD HAVE THE RANGE OF EXPERTISE TO JUDGE QUALITY OF SCIENCE IN ALL STUDY SECTIONS THROUGH THE NEI. I'M 100% SURE OF THAT STATEMENT. SO I'M WORRIED THE PROCESS -- PLEASE UNDERSTAND I REALIZE IT'S DIFFICULT. LET ME STEP BACK ANYTHING CAN BE IMPROVED, I TOTALLY BELIEVE STUDY SECTIONS CAN BE IMPROVED. SO I WANT YOU TO UNDERSTAND THAT IS MY PERCEPTION. BUT THE PROCESS DOES HAVE A BIG IMPACT ON THE WORK PRODUCT. I'M WORRIED ABOUT THAT ASPECT OF HOW THIS THIS CONCLUSION CAME ABOUT. THE THIRD ISSUE IS METHOD OF EYENALSIS WHICH IS DEEPLY RELATED TO GROUND TRUTH. LOOKING AT PUBLICATION CITATION IS A USEFUL BUT ABSOLUTELY INCOMPLETE WAY OF JUDGING THE IMPACT. ALBERT EINSTEIN H INDEX IS LIKE ORDER OF MAGNITUDE LOWER THAN THE CURRENT PERSON ALIVE. WITH A HIGH STAGE INDEX. SO ANOTHER PROBLEM WITH WHAT IS THE GROUND TRUTH THERE. THE LAST ISSUE HAS TO DO WITH THE COMPLEX NATURE OF JUDGING SCIENTIFIC APPLICATIONS. WHAT I MEAN BY THAT, SOME ASPECTS OF SCIENCE ARE VERY GENERIC. SO IN THAT SENSE I THINK THIS IDEA WORKS PERFECTLY WELL. SOMEBODY CAN FIND A FLAW HOW YOU ARE DOING CELL CULTURE, THEY DON'T NEED TO BE EXPERT IN THAT PARTICULAR CELL TYPE THOUGH IT WOULDN'T HURT. IN OTHER WAYS, THEY ARE HIGHLY SPECIFIC. SO YOU CAN'T EXPECT TO SAY A CORNEAL ENDOTHELIAL CELL CULTURE EXPERT TO ACTUALLY KNOW DETAILS ABOUT CULTURE RECEPTORS. UNFORTUNATELY SOMETIMES JUDGING THE SCIENTIFIC EXCELLENCE OF THE PROPOSAL, HINGES ON THAT KIND OF VERY DETAILED KNOWLEDGE. SO I THINK LOGISTICS HOW YOU OPERATIONALIZE THIS ARE DAUNTING. THAT OF COURSE IS A THEORETICAL CONCERN WHICH YOU COULD WORK OUT BY SEEING WHETHER IT QUOTE WORK OR NOT BUT THAT IS TO ME LIKE FIGURING IF THIS NEW WAY OF FLYING THE AIRPLANE WILL WORK WHILE AT 35,000 FEET. SO THIS WORRIES ME ABOUT NATURE OF THE EXPERIMENT. A, HOW DO YOU KNOW WHEN IT'S NOT WORKING? THE I HAVEN'T HEARD A BELIEVABLE METHODOLOGY FOR THAT BASED ON CONCERNS THAT I RAISE, I THINK IRREFUTABLE FROM A LOGICAL STANDPOINT. AND THE SECOND THING IS, IF IT'S NOT WORKING, HOW DO YOU FIX IT? WHEN THE PLANE IS LOSING ALTITUDE AT 10,000 FEET A MINUTE, WHAT DO YOU DO THEN? >> MANY QUESTIONS, MANY EACH WHICH IS WORTH DISCUSSION. LET ME TRY WALK THROUGH SOME OF THESE WE WORK BACK THROUGH THEM. I THINK IT'S IN SOME WAYS, EASIER TO KNOW THAT A STUDY SECTION IS NOT WORKING THEN TO KNOW THAT IT IS WORKING. I KNOW STUDY SECTIONS ARE NOT WORKING. YOU SEE PROBLEMS. YOU SEE PROBLEMS IN SCORING PATTERNS. YOU CAN SEE GROUPS NOT TALKING TO EACH OTHER. YOU CAN -- YOU CAN SEE DYSFUNCTIONAL PATTERNS. WE HAVE A VARIETY OF TOOLS TO STEP IN. SOMETIMES THAT'S A MATTER OF THE CHANGING PEOPLE ON THE COMMITTEE, SOMETIMES MATTER OF WORKING WITH THE SROs OR CHIEFS, SOMETIMES IT'S A MATTER OF HELPING REVIEWERS UNDERSTAND BETTER THEIR ROLES AND RESPONSIBILITIES. BUT THE FIRST -- THERE'S A LOT OF QUICK INDICATIONS THAT STUDY SECTIONS ARE NOT WORKING. THAT, I'M LESS CONCERNED ABOUT. THE FUNDAMENTAL QUESTION OF HOW DUE JUDGE STUDY SECTION OUTPUT? IN THIS IMPORTANT WAY ULTIMATELY WHAT IS THE KNOWLEDGE THEY ARE PUSHING OUT? IT IS A TOUGH ONE. IT'S REALLY TOUGH. IF YOU GOT GOOD ANSWERS, SOMETHING WE CAN'T IGNORE. WE HAVE TO THINK ABOUT IT M. THE APPROACH AT CSR IS TO LOOK AT MULTIPLE INDICATORS. I DON'T THINK ANYONE -- SO TAKE CITATIONS. ALL RIGHT. THERE'S PROBLEMS WITH CITATIONS FOR SURE. THEY ARE PROBABLY BETTER THAN COUNTING PUBLICATIONS. PROBABLY BETTER THAN JOURNAL IMPACT FACTORS. SO THERE'S SOMETHING. YOU CAN LOOK AT PUBLICATIONS COMING OUT OF FUNDED GRANTS. THERE'S LOTS OF ISSUES WITH THAT. IF NO PUBLICATIONS COME OUT OF A GRANT EIGHT YEARS AFTER IT'S BEEN FUNDED P THAT'S PROBABLY A PROBLEM. >> DO YOU KNOW HOW MANY PUBLICATIONS HAMILTON SMITH HAD WHEN HE WAS NOMINATED FOR TENURE AT HOPKINS? AND THE PRION STORIES AND -- YOU SEE WHAT I'M -- I MEAN, OF COURSE I AGREE WITH YOU, COLOCATIONS ARE NOT UNIMPORTANT BUT I'M VERY WELL AWARE, AS YOU OBVIOUSLY ARE, THAT THAT IS REALLY NOT A SATISFACTORY WAY OF JUDGING QUALITY. >> WE NEED BETTERED WAYS S. SO YOU LOOK AT THINGS LIKE THAT. THERE'S OTHER INDICATIONS, CLINICAL STUDY SECTIONS THAT PEOPLE -- DOESN'T PAY OUT IN NEW DRUG APPLICATIONS, PAY OUT IN PATENTS A. , DOES IT PAY OUT IN CLINICAL GUIDELINES? YOU CAN TRY -- WE CAN THINK ABOUT THINGS LIKE YOU CAN DO CERTAIN NETWORK ANALYSES OF IDEAS, IDEAS SORT OF PEDIGREE IDEAS, LOOK AT THOSE IMPACT. THERE'S ISSUES WITH ALL THESE. RIGHT? >> I WILL SAY I ABSOLUTELY DON'T WANT TO DOMINATE BUT IN THE WORLD THAT I LIVE IN, THIS IS WHAT I HAVE LEARNED SO FAR. WHEN WE ARE TRYING TO MAKE A BIC DECISION WHICH IS WHAT YOU ARE DOING AND YOU HAVE TWO GROUPS OF PEOPLE THAT DON'T AGREE WITH EACH OTHER, PRINCIPLE DISAGREEMENT IT IS NOT A QUESTION, YOU CANNOT BRING ABOUT A SATISFACTORY RESOLUTION. BY SOME SORT OF -- THAT NEVER IS A SATISFACTORY SUSTAINABLE SOLUTION TO THE PROBLEM. IN MY OPINION IT'S BETTER TO ACHIEVE A CONSENSUS DECISION. THE WAY THAT COB ACHIEVED, IF IT'S POSSIBLE, TOE HAVE THOSE TWO GROUPS THAT DON'T AGREE WITH EACH OTHER, MEET WITH EACH OTHER AND DISCUSS IT AND COME TO SOME CONSENSUS DECISION WHICH I PREDICT WILL BE BETTER THAN DECISION MADE WITH ABSOLUTELY CONSTRUCTIVE INTENTION. I UNDERSTAND THAT. BUT IT WILL BE BETTER THAN THE ONE THAT'S CURRENTLY COMING OUT. I JUST THINK BECAUSE GET BACK TO THE GRAND QUESTION, I CLAIM THERE'S NO EVIDENCE THAT THE STUDY SECTIONS ARE NOT WORKING. YOU SEE? IN FACT I THINK I CAN CONCLUDE THEY WORK BETTER THAN OTHER STUDY SECTIONS. >> WHAT WE HAVE -- WE HAVE THE PROBLEM OF FIXING THE AIRPLANE WHILE IT'S FLYING. BUT I DON'T THINK WE HAVE A CHOICE. I DON'T THINK'S SATISFACTORY FOR US TO SAY WHAT WE HAVE GOT, WE SAY IT'S OKAY, WE'RE JUST GOING TO LEAVE IT ALONE. THAT INSULAR EVALUATION IS NOT -- I DON'T THINK IT'S WISE, I DON'T THINK IT'S -- I DON'T THINK IT'S -- NO, NO. I UNDERSTAND YOU ARE NOT. I UNDERSTAND YOU ARE NOT. SO THIS IS -- SO WHAT WE HAVE TRIED TO DO IS TO ENGAGE MULTIPLE STAKEHOLDER, MULTIPLE INTERESTED PARTIES. HOW YOU INTEGRATE THAT. IS TOUGH. FOR ONE THING IT'S NOT JUST -- SO EXTERNAL SCIENTIST, THERE'S A LOT OF YOU OUT THERE. WHO SPEAKS FOR THEM. HOW DO WE -- THAT'S NOT A THING WHERE YOU CAN SIT DOWN AND HAMMER UP BECAUSE THERE'S VOICES AND SOMEHOW WE HAVE TO TAKE THAT INFORMATION TOGETHER AND SO I DO THINK WE DO BETTER BY TRYING TO ENGAGE LOTS OF GROUPS,, DO OUR BEST TO SEE HOW SOLUTIONS PAY OUT OVER TIME. AND BE WILLING TO CHANGE THEM IF THEY ARE NOT FUNCTIONING WELL. WHICH WE ARE. YEAH. >> FIRST OF ALL, I WANT TO APPLAUD YOUR EFFORTS BECAUSE I THINK OVERALL YOU LAID OUT IT'S A SERIOUS ISSUE, IT IS IMPORTANT TO ALL OF US. AS TAXPAYERS THE BEST SCIENCE IS FUNDED. SEEMS TO ME THIS IS MOVING FORWARD ONE OF THE WAYS WE REALLY ENSURE THAT YOUR GOAL AND GOAL OF US AND TAXPAYERS, SO ON IS ACHIEVED, IS IN -- SEEMS TO ME AN SRO WHO FULLY EMBODIES THE PHILOSOPHY THAT WE HAVE AND THAT YOU HAVE, ABOUT BEST SCIENCE,S SROs SO CRITICAL FOR HOW STUDY SECTION WORKS, IT'S JUST SO IMPORTANT. IF THAT PHILOSOPHY CAN BE VIEWED IN ALL THE MEMBERS, YOU HAVE A VERY GOOD CHANCE OF A VERY UNBIASED PRODUCT, ALL OF US IN THIS ROOM HAVE FELT ONE TIME OR ANOTHER IF A STUDY SECTION WAS BRILLIANT BECAUSE WE GOT FUNDED. THEY WERE FULL OF IDIOTS BECAUSE WE WERE TRIAGED. SO IT BECOMES SO PERSONAL THE LEADERSHIP THAT YOU HAVE OF YOUR STUDY SECTIONS REALLY DICTATES THE OUTCOME SOON. >> I COULDN'T AGREE MORE. I WILL SAY THAT AMONG -- THE CURRENT -- NEW DIRECTOR OF CSR IS VERY AWARE OF THE IMPACT SROs HAVE ON STUDY SECTION FUNCTION. SHE ABSOLUTELY WANTS TO MAKE SURE WE HAVE HIGHEST FUNCTIONING SROs POSSIBLE STARTING HIRING THE BEST PEOPLE TO TRAINING AND COACHING TO LET EVERYBODY BY ALL OF OUR STAFF BE BEST SROs POSSIBLE. IT IS A CRITICAL THING FOR US, I ABSOLUTELY AGREE WITH YOU. BECAUSE IT GOES IT'S NOT THAT THE SRO CONTROLS WHAT SO MUCH THAT HAPPENS BUT THE SRO MAKES SO MANY DECISIONS ABOUT WHO IS GOING TO BE THERE AND HAS SUCH AN IMPORTANT ROLE IN TRAINING, EDUCATING REVIEWERS, THAT IT REALLY IS REALLY IMPORTANT. I COULDN'T AGREE MORE. >> THANK YOU. I HAVE TWO QUICK QUESTIONS. ONE IS WHEN YOU MENTION -- I'M HIKING ABOUT THE DPVS STUDY SECTION TWO DIFFERENT STUDY SECTIONS. WHEN YOU MENTION ABOUT THE CHIEFS, ARE THE CHIEFS THE SROs, WHO DO YOU -- THERE'S ONE SORT OF -- >> THE WAY WHAT I WAS SAYING IS WHEN IT WORKS, THE IRG CHIEF, IRG CHIEF OVERSEES ANYWHERE FROM FIVE TO 12 STUDY SECTIONS. SO THERE WILL BE A SINGLE CHIEF WHO OVERSEE THE TWO PATHOPHYSIOLOGY AND DISEASE ONES. THE CHIEF PLAYS A CRITICAL ROLE IN REFERRAL OF APPLICATIONS SO THEY FLOW THROUGH THE CHIEF SO THAT PERSON HAS TO BE A VERY ATTENTIVE TO THAT REFERRAL. >> I HAVE A HYPOTHETICAL QUESTION. SAY YOU HAVE THE SAME QUALITY SCIENCE TO GRANTS, THE SAME QUALITY SCIENCE, ONE DPVS AND ONE IN THE OTHER, BECAUSE OF THE WAY THE STUDY SECTION SOMETIMES BAROMETER HOW THEY HAVE THEIR SCORES,SABLE THEY MAY COME OUT SCORE DIFFERENTLY, HOW ARE YOU GOING TO ACHIEVE FAIRNESS REGARDING PERCENTILE POTENTIAL FUNDING THOSE GRANTS. >> IF IT IS JUST AN ISSUE ONE STUDY SECTION IS A BUNCH OF TOUGH GRADERS AND THE OTHERS SWEET HEARTS, APPLICATIONS ARE PERCENTILED WITHIN EACH STUDY SECTION SO EACH ONE FORMS ITS OWN PERCENT TEAL BASE CONTAINED COMPETITIVE POOL, THE MEAN IS FIVE IN ONE STUDY SECTION, TWO IN ANOTHER IF IT'S TWO IT'S A MESS. BUT PERCENTILE AGAINST IT, THAT'S ADJUST JUSTED, YOU PAY ATTENTION TO PERCENTILE SCORES MAKING RECOMMENDATIONS FOR FUNDING. SO THAT GETS ADJUSTED. THERE IS A BROADER ISSUE, YOU WANT STUDY SECTIONS TO HAVE SIMILAR CULTURES IN THE SENSE OF APPRECIATING THE SAME THINGS IMPORTANT IN REVIEW. WE HAVE AN IMPORTANT CHALLENGE EDUCATING REVIEWERS SO YOU DO HAVE UNIFORMITY ABOUT THAT. ACROSS STUDY SECTIONS. >> THANK YOU. I HOUSE OF REPRESENTATIVES HOW DIFFICULT THIS PROBLEM IS FOR THE EFFORT. YOU PRESENT TWO PROBLEMS ONE IS BLUE OTHER STUDY SECTION WITH RED BOXES STUDY SECTION THAT HAS THERE IS ANOTHER PROBLEM THAT YOU DIDN'T INCLUDE IN YOUR PRESENTATION. THAT MEANS WHEN YOU HAVE A SMALL POCKET OF STRONG GRANTS FOLLOWING STUDY SECTION THAT IS (INAUDIBLE) BY DIFFERENT EXPERTISE. THEN,, I KEEP HEARING FROM MY COLLEAGUES IN CIRCUITRY FOLLOWING THIS NDRC STUDY SECTION WE ARE NOT TREATED FAIRLY. JUST TO VERIFY IF THEY ARE RIGHT CHECK IN ADDITION ROUND OF REVIEW I SAW IT WAS ONLY ONE OF TEN THAT GOT COMPETITIVE SCORE. HOW DO YOU HANDLE THAT? Z FROM >> I SEE THAT AS AN ISSUE. I HEAR THAT AS A DESCRIPTION OF THE CAMPUS PROBLEM. YOU HAVE AN AREA OF SCIENCE MINORITY AREA WITHIN A STUDY SECTION THAT'S NOT APPRECIATIVE BY BROADER SECTION. LET ME GIVE TWO LEVELS OF ANSWER. RETINAL CIRCUITRY STUFF IS GOING TO MOVE OVER TO BDS. MY OWN PERSONAL VIEW IS IT DIDN'T NEED TO HAPPEN BUT IT IS HAPPENING, I THINK IT WILL MAKE SOME PEOPLE HAPPY. BUT ON THE ISSUE OF -- I THINK SOMETIMES IT'S A MATTER OF JUST THE WRONG PEOPLE BUT SOMETIMES IT'S A MATTER OF WRONG UNDERSTANDING. I THINK IT'S CSR WE NEED TO DO A BETTER JOB OF EDUCATING REVIEWERS ABOUT WHAT THEIR ROLE IS. BY THAT I MEAN, WE WERE NOT SELECTING PEOPLE TO BE SIMPLY SUBJECT MATTER EXPERTS AND THEIR PARTICULAR TOPICS. THAT IS ONE RULE. WE ALSO NEED PEOPLE WHO ARE REVIEWERS WHOP CAN LOOK ACROSS A RANGE OF TOPICS AND AREAS OF SCIENCE AND BE ABLE TO JUDGE THE RELATIVE IMPORTANCE OF THE WORK. SO THEY NEED TO BE PEOPLE WHO CAN MAKE BROADER JUDGMENTS. THAT'S ONE ROLE, NOT THERE JUST TO REPRESENT THE METHODS THAT THEY KNOW. THEY MAKE JUDGMENTS ABOUT A RANGE OF SCIENCE, THAT'S ONE OF THE MOST IMPORTANT FUNCTIONS REVIEWERS ON PANELS DO. >> HAVE YOU CONSIDERED GIVE CONSIDERATION USING NATURAL LANGUAGE PROCESSING TO HELP YOU IN THIS DAUNTING JOB YOU HAVE, WITH REGARD TO GROUND TRUTH AND YOU HAVE PREEXISTING DATA SO YOU CAN FIND OUT WHAT ARE GOOD REVIEWS, WHAT ARE BAD REVIEWS, WHAT IS FOOD SCIENCE, WHAT IS PAD SCIENCE AND PERHAPS THAT CAN HELP GUIDE THIS PROCESS. >> TREMENDOUS NUMBER OF QUESTIONS CSR DEALS WITH WHERE THERE IS A POTENTIAL FOR ARTIFICIAL INTELLIGENCE TO HELP US UNDERSTANDING ALL KIND OF QUESTIONS CRUCIAL TO OUR FUNCTION. WE ARE MAKING INCREASED INVESTMENTS AND MET WITH WORK GROUP AT CSR YESTERDAY, WORKING ON A NUMBER OF TOPICS, IT'S ABSOLUTELY, THIS IS SOMETHING WE NEED, WE NEED TO SPEND MORE MONEY ON IT, IN THE -- THIS IS GOING TO SHAPE THINGS GOING FORWARD. IT WILL TAKE A WHILE TO GET THERE. >> MY MAIN CONCERN ABOUT WHAT'S GOING ON, THERE'S BEEN A LACK OF APPRECIATION OF THE EXPERTISE WITHIN NEI AND THE ADVICE NEI HAS BEEN ABLE TO PROVIDE. SEEMS TO HAVE BEEN DISCARDED BY CSR. THE PANEL I WAS ON HAS A SPECIFIC RECOMMENDATION GOING FORWARD. IT'S BEEN IGNORED. RECOMMENDATIONS OF NEI WHO REALLY KNOWS, THEY HAVE HISTORY BEHIND OF FUNDING EXCELLENT RESEARCH IN NEUROSCIENCE. AND EYE DISEASE. IT'S NOT BEEN TAKEN INTO CONSIDERATION AS STRONGLY AS IT SHOULD BE BY CSR. WE AS INDIVIDUAL SCIENTISTS CANNOT PROVIDE DEPTH OF INFORMATION ABOUT PERSONAL EXPERIENCE BUT HISTORICAL INSTITUTIONAL KNOWLEDGE THE NEI HAS ABOUT HOW TO GET THE BEST SCIENCE FUNDED NEEDS TO BE LISTENED TO. I KNOW THERE'S A SEPARATION BETWEEN POWERS OF PROGRAM AND CSR. BUT STILL I THINK THERE SHOULD BE MORE DISCUSSION AMONG THOSE THINGS. THE SECOND, J 81 AROSE BECAUSE OF AAD CLOSED DOWN A NUMBER OF YEARS AGO. IT AROSE AS A -- STOP GAP MECHANISM TO ASSIST IN THE FUNDING OF ANTERIOR EYE DISEASE GRANTS WHICH WERE NOT GETTING PERCEPTION THEY WEREN'T FUNDED PROPERLY WITHIN THE CONTEXT OF EXISTING STUDY SECTIONS AND WE HAVE SEP THAT AROSE. WHOSE IT SEEMS TO HAVE BEEN COMPARED AGAINST STANDING CHARTERED STUDY SECTION FOR QUALITIED AND ABILITY TO FUNCTION, ET CETERA. IT NEVER WAS A CHARTERED STUDY SECTION, IT WAS A CONSISTENT TO THINK FIRST ABOUT HISTORY OF J 81 BUT COMPARE FUNCTIONALITY OF J 81 TO OTHER STANDING STUDY SECTIONS AND TO -- I'M SENSING IMPLICIT STUDY SECTION DIDN'T THINK WAS DOING A GOOD JOB, THAT'S WHY THEY DIDN'T THINK IT VALID TO CHARTER, IS NOT FAIR. >> I WAS DIVISION DIRECTOR AT THAT TIME. I THOUGHT J 81 WAS WORKING WELL. WE HAD -- IN THE ROOM. IF SHE WASN'T HERE, I THOUGHT J 81 WAS WORKING WELL, I WAS HAPPY TO CHARTER THE STUDY SECTION, COUNCIL SAID NO. SO IT WAS NOT ISSUES ABOUT HOW WELL THE STUDY SECTION WAS FUNCTIONING. IT WASN'T. ON THE FIRST POINT IT IS DIFFICULT TO PERSUADE PEOPLE THAT YOU HAVE LISTENED TO THEM WHEN YOU DON'T DO WHAT THEY ASK. I THINK THAT'S THE CASE HERE. IT REALLY IS A CASE CSR MADE EVERY EFFORT TO TAKE SERIOUSLY THE FEEDBACK WE HAVE GOTTEN NOT JUST FROM COUNCIL. CERTAINLY WE WANT COUNCIL INPUT BUT WE ALSO WE TOOK THE INPUT FROM THE FIRST PANEL SERIOUSLY. WE DO HEAR THAT. AND WE ARE ALSO AWARE OF HISTORY. HISTORY IS SOMETHING WE ARE AWARE OF, NOT DETERMINENATIVE. THINGS CHANGE. WHAT I THINK IS THIS SORT OF IS THE HISTORY GIVES US ISSUES WE OUGHT TO BE AWARE OF GOING FORWARD. DIRECTS US TO CONCERNS WE NEED TO BE AWARE OF AND TRY TO ADDRESS TO MAYBE SHOE THAT THEY DON'T RECUR IN THE NEW STUDY SECTION. AS I SAID,S WE WANT TO WORK -- WE WANT TO MAKE THESE WORK. WE'RE GOING TO GO AHEAD, WE WANT TO -- WE WILL IMPLEMENT. FOR WHATEVER IT'S WORTH, IF I HAVE DIRECTOR I WOULD BE IMPLEMENTING THAT, THAT WOULD BE AT THE TOP OF MY SECTION, THERE'S STUDY SECTIONS I WOULD NOT BE SAYING THAT, THESE ARE STUDY SECTION I THINK NOT FUNCTIONING WELL, WE NEED TO DO SOMETHING. THIS ONE WOULD HAVE BEEN AN ASSIGNMENT LIKE YEAH WE CAN MAKE THIS WORK. THAT'S MY OPINION, I KNOW YOU HAVE A DIFFERENT OPINION BUT I THINK THIS IS A SITUATION WHERE CSR REALLY HAS RISEN THE END OF THE DAY MADE A DECISION DIFFERENTLY, DIFFERENT THAN I THINK YOU WOULD HAVE LIKED. >> WE ARE RUNNING LATE. ONE FINAL QUESTION, HOW MANY TWIN STUDIES EXIST NOW? >> I DON'T KNOW OFF THE TOP OF MY HEAD. THERE IS A FEW. HOW MANY YEARS HAVE THEY BEEN RUNNING? THE >> MANY YEARS. >> THIS IS A MODEL TRIED OUT. >> WE HAVE A NUMBER OF TWIN STUDY SECTIONS THAT WERE SATISFACTORY. >> YOU CAN'T NAME ONE. SEEMS TO ME, I DON'T LIKE AN EXPERIMENTAL MODEL, SEEMS THOUGH WE WILL HAVE A AND B LIKE WE USED TO 30 YEARS AGO. IN ESSENCE. >> I'LL BE HAPPY TO FOLLOW UP WITH YOU TO GIVE SOME LIST. I KIND OF THOUGHT ABOUT THIS QUESTION ALREADY. IT'S NOT -- I DON'T THINK IT'S THE ISSUE OF WHETHER OTHER TWINS WORK. IT'S WHETHER THIS ONE WILL WORK. MY OWN ESTIMATE IS THIS ONE CAN WORK FINE. LET'S TRY TO MAKE IT WORK, SEND US SUGGESTIONS ON REVIEWERS, WE WILL BE KEEPING AN EYE ON THINGS. I THINK WE CAN. >> I THINK WE CAN ENTERTAIN ONE QUICK QUESTION THEN WE HAVE GOT TO MOVE ON. >> HERE IS AN IDEA M. (INDISCERNIBLE) JOURNAL OF NEUROSCIENCE, ONE TOOL THEY FOUND HELPFUL WAS THE INFORMATION THEY HAD ON REVIEWERS. YUMMY HOW LONG THEY WERE. IS THERE ANY WAY TO GET SOME INFORMATION SROs BY ALLOWING FEEDBACK? THE GRANTS THE PIs, AS REVIEWERS ARE EVALUATING THE PIs, PIs REVIEWERS HAVE -- (INDISCERNIBLE) SRO LIKE ANONYMOUS FEEDBACK SO THAT YOU CAN GET SOME BECAUSE AT THE END OF THE DAY WE WOULD LIKE THAT, REVIEWERS SROs TO TELL US WHAT IS GOOD SCIENCE, WHAT IS NOT GOOD SCIENCE. >> >> WE ARE INTERESTED IN BETTER TRAINING OF REVIEWERS, PART OF THAT MAY BE BETTER MONITORING OF REVIEWER SCORE PATTERNS FOR EXAMPLE. WE GET SURVEYS FROM STUDY SECTIONS ABOUT HOW IS THE STUDY SECTION WORKING. WE GET FEEDBACK FROM STUDY SECTIONS REGARDING SRO PERFORMANCE. GOING TO THE LEVEL OF HAVING THE PIs RATE THE CRITIQUES THEY GET AND GET BACK SOMETHING I DON'T THINK WE ARE READY TO DO. >> THANK YOU, BRUCE. I KNOW WE'LL CONTINUE THIS DISCUSSION. AARON LEE SPEAK FIRST, HE WILL BE INTRODUCED BY OUR RETINAL PROGRAM STAFF TOM GREENWELL. >> THANK YOU, ANNIE. I HAVE THE HONOR OF INTRODUCING DR. LEE. HE RECEIVED HIS BACHELOR'S DEGREE FROM HARVARD. AND ALSO AWARD AT THAT TIME FOR EXCELLENT CODING. HIS M.D. FROM WASHINGTON UNIVERSITY, MASTERS OF SCIENCE AND CLINICAL INVESTIGATIONS ALSO FROM WASHINGTON UNIVERSITY. IN ST. LOUIS. HE'S A TVST EDITOR. HE PUBLISHED EXTENSIVELY ON RETINAL DISEASES AND ANALYSIS OF OCT IMAGES, FUNDUS IMAGE AND DIABETIC RETINOPATHY, PUBLISHED IN GOOD JOURNALS INCLUDING SCIENTIFIC REPORTS. AND IS NOW AFULLIATE PROFESSOR -- I'M SORRY, ASSISTANT PROFESSOR OF OPHTHALMOLOGY AT THE UNIVERSITY OF WASHINGTON. SO HE WENT FROM WASHINGTON UNIVERSITY TO UNIVERSITY OF WASHINGTON. I DON'T WANT TO TAKE A BUNCH OF TIME INTRODUCING HIM, I WANT TO HEAR THE SCIENCE WHICH IS STILL SOME OVER MY HEAD. I'M PLEASED HE IS HERE, WE HAVE THIS TALK. THANK YOU FOR COMING, DR. LEE AND THANKS FOR LETTING ME INTRODUCE THEM. >> THANKS VERY MUCH FOR THE INTRODUCTION. AARON LEE FROM UNIVERSITY OF WASHINGTON. THESE ARE MY DISCLOSURES. I'M GOING TO START BY GIVING AN INTRODUCTION INTO SOME OF THESE TERMINOLOGIES AND THEN GO DOWN HOW WE WENT DOWN THE ROUTE THAT WE DID. JUST WANT TO START BY SAYING WE FIRMLY LIVE IN THIS ERA OF BIG DATA MACHINE LEARNING. OUTSIDE LEARNING SO EVERY TOO MANY YOU PICK UP YOUR PHONE, SEARCH FOR SOMETHING, ON THE YOU- SEARCH ENGINE, THAT DATA IS BEING COLLECTED, THAT DATA IS PROCESSED AND ALGORITHMS ARE POWERING WHAT YOU SEE WHAT YOU READ. IT VERY MUCH WE LIVE HUMAN RACE IS LIVING IN THIS ERA NOW. IT GET ASKED WHAT EXAMLY -- I GET ASKED WHAT IS BIG DATA. I THINK IN TERMS OF THESE AXES. ONE IS VOLUME, THE OTHER IS VELOCITY AND THIRD IS VARIETY. I THINK IT'S INTERESTING TO THINK ABOUT EYE CARE WITH RESPECT TO THESE AXES. RIGHT NOW WITH COMPUTATIONAL STRUCTURE AS MOST HOSPITALS WE CAN RUN ANALYSES IN YOUR REAL TIME IF NOT REAL TIME. IN OPHTHALMOLOGY, WE WILL ARE COLLECTING TONS OF DIFFERENT KINDS OF IMAGING. SOMETIMES EVEN MOVIES, AS WELL. I THINK WHAT SETS APART OPHTHALMOLOGY FROM OTHER FIELDS OF MEDICINE, WE ARE ALSO WELL STRUCTURED DATA ELEMENTS THAT ARE PART OF OUR ELECTRONIC HEALTH RECORD. WHEN YOU LOOK AT THE REGISTRY, THE SCALE OF THE IRIS REGISTRY WHICH DOESN'T INCLUDE IMAGING IS ALREADY SITTING AT SOMEWHERE BETWEEN TERABYTES AND PEDABYTES OF DATA SO SAFE TO SAY EYE CARE IS BIG DATA. THE OTHER THING TO THINK ABOUT IS TOOL SETS THAT ARE AVAILABLE TO ANALYZE THESE THINGS. THINK ABOUT THEM ON ONE AXES IS SIZE OF DATA SETS, THE OTHER IS COMPLEXITY OR VARIETY OF DIFFERENT KIND OF DATA ELEMENTS. ONE OF THE DEFINITIONS OF BIG DATA IS YOU CAN'T USE MICROSOFT EXCEL. BECAUSE THE DATA IS TOO COMPLEX OR TOO BIG TO FIT INTO A SPREADSHEET. THEN WE HAVE THESE OTHER STATISTICAL LANGUAGES LIKE SBSSR AND SAS. I CAN DEAL WITH LIMITED VARIETY OF DATA BUT THEY CAN'T SCALE UP TO LARGE NUMBER OF ROWS. THEN I PUT PENOLOGY UP HERE, BECAUSE IT'S ONE OF THE MORE POPULAR GENERIC PROGRAMMING LANGUAGES BUT IT COULD BE ANY COMPUTER LANGUAGE. THOSE CAN BE FLEXIBLE ENOUGH TO DEAL WITH ANY DATA ANY SCALE, BUT YOU HAVE TO CUSTOM WRITE YOUR OWN CODE EVERY TIME. I VIEW THE BOTTOM HALF OF THE GRAPH AS PLACES WHERE TRADITIONAL STATISTICS CAN PLAY A LARGE ROLE. THE UPPER RIGHT CORNER OF THIS GRAPH IS WHERE MACHINE LEARNING IS REALLY NEEDED HANDLE THAT DATA AT THAT SCALE. THE REVERSE IS TRUE TOO. NECESSARY INGREDIENTTOR MACHINE LEARNING IS VERY OFTEN THAT YOU NEED LARGE DATA SETS. WHAT IS MACHINE LEARNING? I THINK IT'S KIND OF DISSERVICE THAT MEDIA MIXES THESE TERMS UP, THEY HAVE FORMAL DEFINITIONS SO THE FIELD OF AI IS OLD VERY BROAD. SUBSET OF THAT IS MACHINE LEARNING, SUBSET OF THAT IS RELATIVELY NEW FIELD CALLED DEEP LEARNING. WHAT IS DEEP LEARNING? IT'S AN EXTENSION OF ARTIFICIAL NETWORKS. IT THE OLD ARTIFICIAL NETWORKS IN THE 90s HAD ONE TO THREE FULLY CONNECTED LAYERS. AND DEEP LEARNING IS TAKING THAT TO ANOTHER EXTREME. IN MY OPINION THERE'S FOUR ADVANCES THAT LED TO THE BIRTH OF WHAT WE CALL DEEP LEARNING TODAY. ONE WAS REALIZATION THAT YOU CAN USE GRAPHICS PROCESSING CARDS AND COMPUTERS TO DO LINEAR ALGEBRA. THE OTHER THIS IS A KEY POINT, THERE ARE SPATIALLY AWARE NEURAL LAYERS THAT TAKE ADVANTAGE OF IMAGES. THE USE OF NON-LINEAR ACTIVATION FUNCTIONS ALLOWED US TO BUILD VERY DEEP NEURAL NETWORKS AND FINALLY LIKE I SAID YOU HAD COMPUTER INFRASTRUCTURE HAD ADVANCED TO THE POINT WHERE WE CAN START TO COLLECT DATA. WE LIVE IN THIS EXCITING TIME NOW WHERE YOU CAN BUILD LARGE NEURAL NETWORKS AND AS YOU FEED MORE DATA THEIR PERFORMANCE SEEMS TO INCREASE MORE AND MORE. SO I WANT TO GIVE BACKGROUND STORIES OF WHAT INSPIRED US AND ONE OF THE VERY FIRST THINGS I DID WHEN I JOINED THE UNIVERSITY OF WASHINGTON WAS TO APOLOGETIC OPTICAL COHERENCE TOMOGRAPHY OCT IMAGING FROM OUR HOSPITAL. THAT TODAY IS ABOUT FIVE AND A HALF MILLION OCT B SCAN IMAGES OF 90,000 VOLUMES, 16,000 PATIENTS FOR MORE THAN TEN YEARS OF TIME SCANNED WITH THE SAME PROTOCOL. THE KEY POINT HERE IS THAT BECAUSE WE HAD THE ELECTRONIC HEALTH RECORD WE CAN GO LINK EACH ONE OF THESE VOLUMES TO THE VISUAL ACUITY, DIAGNOSIS, INTERVENTIONS, AND THE INTERPRETATIONS. BECAUSE OF THAT WE COULD START TO DO INTERESTING THINGS. ONE OF THE VERY FIRST QUESTIONS WE ASKED WAS WHAT I THOUGHT WOULD BE A VERY FIRST IMPORTANT FIRST STEP TO SEE WHETHER DEEP LEARNING COULD DISTINGUISH BETWEEN NORMAL AND AMD OCT IMAGES. TO DO THAT WE TOOK A DATA SET OF 100,000 IMAGES AND TRAINED THIS NEURAL NETWORK BGD 16 WHICH IS NOW A CLASSIC DEEP LEARNING MODEL. WITHIN A DAY WE TRAINED OUR FIRST MODEL AND ACHIEVED THESE STATISTICS. I WAS FLOORED, AND I WAS SHOCKED HOW WELL DEEP LEARNING COULD DO BUT I FELT NERVOUS ABOUT PUBLISHING THIS RESULT BECAUSE I DIDN'T KNOW IF IT WAS CHEATING SOMEHOW. IT JUST SEEMED TOO GOOD TO BE TRUE. IT KIND OF SPEAKS TO THIS PROBLEM THAT DEEP LEARNING HAS, IT'S A BLACK BOX. WE HOPE AND WE TRUST THAT THE ALGORITHM IS DOING SOMETHING USEFUL BUT NO WAY TO GUARANTEE THAT. I WAS FRUSTRATED BY THIS. THOUGH IT TOOK ONLY A DAY TO GET OUR FIRST RESULT I SPENT WEEKS AFTER TO THINK OF WAYS TO VALIDATE. I EVENTUALLY FOUND THIS -- ONE WAY I THOUGHT WAS INTUITIVE. IT GOES LIKE THIS. IF I ASKED YOU IS THERE A BALL IN THIS PICTURE YOU SAY WITH 100% CERTAINTY I BELIEVE THERE'S A BALLS IN PICTURE. IF I COVERED UP A SMART PART OF PHOTOGRAPH, I ASK YOU AGAIN YOU WOULD SAY YES. BUT IF I KEEP IT RATING THAT BOX AND I MOVE IT AROUND TO EVERY POSSIBLE PIXEL POSITION THE BOX WILL END HERE AND I WILL ASK YOU IS THERE A BALL IN THIS PICTURE, YOU WILL SAY I'M NOT SURE ANY MORE. SO THAT'S EXACTLY WHAT WE DID. SO WE TOOK THIS MODEL THAT HAD BEEN TRAINED, ACHIEVED THESE IMPRESSIVE AUROCs AND WE TOOK OCT B SCAN SET WORKED OUT IN PART OF THE TRAINING SET AND SYSTEMATICALLY PERTURBED PART OF THE OCT. WE SEE WHAT HAPPENED TO THE CONFIDENCE OF THAT MODEL IN SAYING THAT THIS WAS AMD OR NOT. BY DOING THAT, YOU COULD OVERLAY HEAT MAPS AND YOU CAN SAY SEE SORT OF AREAS WHERE MODEL WAS DEPENDENT UPON TO MAKE THIS DETERMINATION. THAT MADE ME FEEL MORE COMFORTABLE ABOUT PUBLISHING THIS RESULT AND USING THIS FRAMEWORK WE REALIZE YOU COULD TRAIN DEEP LEARNING CLASSIFIERS TO HOPEFULLY TEACH US ONE DAY SUBTLE DIFFERENCES BETWEEN IMAGE SETS WHERE WE BELIEVE THERE SHOULD BE A DIFFERENCE. THE OTHER PROJECT WE DID SECOND PROJECT IS AUTOMATED SEGMENTATION ALGORITHM WHERE WE TRAINED DEEP LEARNING TO GIVE US THE EXACT PIXEL SEGMENTATION OF FLUID. I'M NOT GOING TO GO THROUGH HOW WE DID THAT BUT THESE ARE RESULTS WHERE LEFT IS INPUT INTO THE MODEL AND THE RIGHT IS THE PROBABILITY SHADING OF THE MODEL SAYING THAT THIS IS INTERNAL FLUID. RED CIRCLE IS HIGHLIGHTING THE MODEL IS NOT GETTING CONFUSED BY SHADOWS UNDERNEATH RETINAL VESSELS. WE DID THIS WHOLE VALIDATION WORK WHERE WE PROVE IT WAS AS GOOD AS EXPERT VARIABILITY. BUT THE MOST INTERESTING PART OF THE PROJECT WAS SOMETHING THAT DIDN'T MAKE IT INTO THE PAPER. IT WAS BECAUSE IT IS HARD TO PUBLISH THIS PARTICULAR RESULT SO HERE WHAT I'M SHOWING YOU IS A MOVIE. WHAT WE ARE DOING IS WATCHING THE MODEL LEARN TO DO THIS TASK OVER TIME. YOU CAN SEE THAT INITIALLY MAKES THIS MISTAKE AND SAYS THAT SHADOW UNDERNEATH THE VESSEL IS INTERNAL FLUID OR SAYS THAT POCKET OF SOUBRETTE MALL FLUID IS INTERNAL FLUID BUT AS IT LEARNS MORE AND MORE, AS IT'S MORE EXAMPLES YOU CAN SEE IT GETTING BETTER OVER TIME. THE HAIR RAISING PART OF OF THIS IS SOMETHING THAT HAPPENED AT THE VERY BEGINNING. I WILL PLAY AND STOP HERE. WHAT I'M TRYING TO SHOW YOU HERE IS THAT THE MODEL WAS ONLY FED OCT IMAGES AND THE MARKS WHERE THE INTERNAL FLUID ARE. YET THIS DEEP LEARNING MODEL REALIZED THAT IT NEED -- IN ORDER TO FIGURE THAT OUT IT HAD TO LEARN WHERE THE ILM AND THE RPE WAS. I FIND THIS TO BE KIND OF HAIR RAISINGLY CRAZY BECAUSE WE HAVE GIVEN IT A TOTAL HI DIFFERENT PROBLEM TO SOLVE. IT HAD GONE AND SOLVED THIS INTERMEDIATE PROBLEM, NEEDED TO LEARN ON ITS OWN BEFORE IT COULD UNDERSTAND WHERE INTRAFLUID WAS. I THINK THIS IS AN EXAMPLE OF THIS EMERGENT BEHAVIOR OF AI THAT IS EXCITING. ONE THING WE TOOK FROM THESE TWO PROJECTS IS THAT MACHINE LEARNING IS LIMITED BY GROUND TRUTH. IT SEEMS TO HAVE INCREDIBLE POTENTIAL. IF YOUR GROUND TRUTH IS ALWAYS LABELED BY HUMAN BEINGS IT WILL NEVER ACHIEVE PERFORMANCE BEYOND THAT. SO WE STARTED TO THINK ABOUT HOW TO PUSH DEEP LEARNING TO DO MORE. SO I'M GOING TO GO OVER SOME OF THE PROJECTS WE DID AFTERWARDS. SO JUST AS AN ASIDE, I CAN I WANTED TO HIGHLIGHT THIS ONE PROJECT WE DID WITH OER. THIS IS A VERY COMMONLY USED ANIMAL MODEL TO STUDY -- WE REALIZED WHEN TALKING TO RESEARCHERS, RESEARCHERS DOING SEGMENTATIONS MANUALLY WERE NOT BLIND TO THE EXPERIMENTAL CONDITION AND THEY WERE NOT INTERNALLY CONSISTENT SO IF YOU ASK THE SAME RESEARCHER WITH THE SAME IMAGE ON A DIFFERENT DAY THEY WOULD PRODUCE DIFFERENT SEGMENTATION RESULTS. SO WE WANTED TO SEE IF WE CAN USE MACHINE LEARNING TO SOLVE THIS PROBLEM SO WHAT WAS HAPPENING BEFORE WAS SOMEBODY TAKE ONE OF THESE IMAGES PUT THEM INTO PHOTO SHOP AND GENERATE THIS SEGMENTATION MASK OF WHERE THE VASOOBLITERATION REGION WAS. IN THE TWO METRICS THEY WANTED WERE TWO RATIOS. WE BROKE IT DOWN AND WE WENT TO COLLABORATE WITH MARTY FREELANDER SITTING ON THIS DATA SET OF A THOUSAND RETINAL IMAGES AND I HEARD SOMEBODY TALKING THROWING AWAY DATA EARLIER, PLEASE DON'T DO THAT FOR THIS REASON. TURNS OUT ALL THIS DATA CHECKED FROM PREVIOUS EXPERIMENTS COULD BE USED TO BUILD THIS AUTOMATED ALGORITHM. WE TRAINED TWO DIFFERENT DEEP LEARNING NETWORKS SO WE CAN BUILD THIS PIPELINE. YOU CAN FEED NEW IMAGE, IT WOULD SEGMENT VASOOBLITERATION REGION SEGMENT COMPLEXES AN SEGMENT THE RETINA AND GET TWO QUANTIFIABLE RATIOS AFTERWARDS. SEEING IS BELIEVING SO HERE IS ON THE LEFT HAND COLUMN THE INPUT OF NEW IMAGES. THE MIDDLE IS HUMAN SEGMENTATION, RIGHT IS DEEP LEARNING, I'LL ADMIT MAYBE ON THE EDGES TYPE LEARNING IS NOT DOING QUITE AS WELL. FOR THE NEOVASCULAR COMPLEX IT DID REALLY SHOCKINGLY AMAZING JOB OF RECAPITULATING THE HUMAN EXPERIMENTMENT THE REALLY IMPORTANT PART OF THIS PROJECT IS NOT THE PUBLICATION BUT WHAT WE DID AFTERWARDS. WE PACKAGED THE ENTIRE PROJECT UP AS A GET HUB REPOSITORY AND OPEN SOURCED ALL OF IT, THE MODEL, THE CODE, THE WEIGHT AND WE REALIZE MOST PEOPLE DIDN'T HAVE THE EXPERTISE TO WORK WITH THESE ENCODES SO WE DEPLOYED A WEBSITE WHERE EVEN TODAY SOMEBODY DOING RESEARCH WITH THESE RETINA IMAGE COULD UP LOAD IMAGE AND AUTOMATICALLY PERFORM THE SEGMENTATION FOR THEM. WE WERE TRYING TO DELIVER ON THIS AND SURPRISINGLY WITHIN NINE MONTHS RELEASING THIS, WE HAD 2000 IMAGES. I THINK THIS IS A WAY TO BRING DEEP LEARNING TO VISION SCIENTISTS TO REALLY ACCELERATE BIOMEDICAL RESEARCH. SO RATHER THAN SPENDING COUNTLESS HOURS TRYING TO DO SEGMENTATION BY HAND TWO CUSS ON EXPERIMENTAL DESIGN AND THE ACTUAL RESULTS THEMSELVES. ANOTHER AREA THAT WE WERE REALLY FASCINATED BY WAS THIS IDEA THAT YOU COULD TAKE STRUCTURAL OCT SCANS, AND FIND THE VESSELS. I REMEMBER THESE PAPERS FROM EARLY 2000s WHERE BEFORE OCTA PEOPLE WERE CIRCLING ALL THESE VESSELS ON OCT B SCANS. BY DOING SO, YOU CAN GENERATE A NICE MAP. I THOUGHT ABOUT DOING THIS. AND THE WAY THAT I WAS GOING TO APPROACH IT WAS COLLECT A BUNCH OF OCTB SCANS, HIRE AN ARMY OF MEDICAL STUDENTS TO GO AND PROVIDE ALL THESE MANUAL SEGMENTATIONS LIKE WE DID IN OIR PROJECT. AND THEN THE FIRST IMAGE INTO THE MODEL TRY TO GET THE MODEL TO GIVE US THE LOCATION OF THE VESSELS. THAT'S THE WAY I THOUGHT I WAS GOING TO DO IT. AND IN COMPUTER VISION WE WOULD CALL THIS INSTANT SEGMENTATION. BUT I REALIZE THAT I DIDN'T HAVE THE FUNDS TO DO THIS OR ARMY MEDICAL STUDENTS TO TORTURE SO I REALIZE IT WAS AT UNIVERSITY OF WASHINGTON WHERE RICKY WANG DOWN THE ROAD WAS DEVELOPING OCTA. AND THE KEY REALIZATION I HAD WAS THAT IF YOU LOOK AT THE OCTA B SCAN, AND LOOK IN THE RETINA, THOSE AREAS THAT ARE HYPERREFLECTIVE ARE WHERE FLOW IS OCCURRING. WHERE HIGHEST AREAS OF FLOW ARE. THAT'S ESSENTIAL LAY MAP OF THE VESSELS. SO WHY NOT SET THIS STRUCTURAL OCT SCAN ADS INPUT, TRY TO GET DEEP LEARNING TO RECAPITULATE THE OCTA B SCAN AND WE SET THAT AS GROUND TRUTH. SO REALLY IMPORTANT POINT HERE IS THAT HERE ARE THE GROUND TRUTH NOT BEING DERIVED BY HUMAN BEING. IT'S BEING DERIVED BY MACHINE CONSTRUCTED MEASUREMENT M. AFTER TWO WEEKS OF TRAINING, WE ACHIEVED THESE RESULTS. TO THIS DAY I'M ASTONISHED BY THE RESULTS. HERE IS INPUT INTO THE MODEL. THE MIDDLE IS GROUND TRUTH AND RIGHT IS THE DEEP LEARNING PREDICTION. I THOUGHT THAT THE MOST DEEP LEARNING WAS GOING TO BE ABLE TO DO WAS FIND VESSELS THAT ARE INDICATED BY THE RED ARROW HEADS, THOSE ARE OBVIOUS. I THOUGHT THERE'S NO WAY TO PICK UP SMALLER VESSELS AND IT WOULD BE BLURRED OUT AS NOISE. BUT IF YOU LOOK AT THE YELLOW ARROW HEADS, DEEP LEARNING WAS ABLE TO TEASE OUT SOME OF THE FLOW IN THE SMALLER VESSELS. IN A WAY EVEN AS CLINICIAN WHEN I LOOK AT THE. IMAGINE ON THE LEFT I CAN'T NECESSARILY IDENTIFY THOSE RELIABLY. IF YOU U COLLECT DENSE ROSTER SCAN AND RUN THROUGH THE MODEL YOU GET THIS. SO THIS WAS NOT GENERATED USING OCTA. IT WAS GENERATED USING STANDARD UBIQUITOUSLY AVAILABLE SPECTRAL DOMAIN OCT RUN THROUGH A DEEP LEARNING MODEL. AN IMPORTANT THING WE DID IN THE TRAINING SET TO NORMAL AND DIABETIC MACULOPATHY AND TESTED IT IN OTHER RETINAL VASCULAR DISEASE. WE DIDN'T WANT FOR IT TO LEARN WAS JUST SOME PATTERN OF DISEASE AND APPLY THAT TEMPLATE OVER AND OVER. SO WHAT ABOUT DISEASE MODEL I HAD NEVER SEEN BEFORE? HERE ARE RESULTS FROM CENTRAL RETINAL ARTERY INOCCLUSION. WHAT YOU SEE ON THE LEFT COLUMN THE FIRST ONE IS THE OCT STRUCTURAL PROJECTION. THE SECOND THE IS DEEP LEARNING, THIRD IS ACTUAL OCTA. AND THE LAST TWO COLUMNS ARE INSETS, I'M NOT HERE THE SAY DEEP LEARNING IS E REQUEST I'VE LENT TO OCT. OF COURSE OCTA IS SUPERIOR BUT I WAS SHOCKED BY HOW WELL DEEP LEARNING COULD TEASE OUT THE FLOW IN SOME OF THE SMALLER VESSELS. THE SAME THING WAS TRUE IN VEIN OCCLUSION. THE WEIRD THING ABOUT THIS IS THAT OCTA IS DERIVED BY REPEATED B SCAN EXACT SAME LOCATION LOOK ACT THE CHANGE IN THE INTENSITY IN FADES. HERE A SINGLE ON AVERAGE B SCAN WAS BEING FED INTO THE MODEL LOOKING AT THESE PICTURES TRYING TO DETERMINE AS A HUMAN BEING HOW FAST EACH PIXEL IS MOVING SO THE QUESTION IS HOW IS THIS POSSIBLE? SO WE COULD HAVE ENDED RESEARCH HERE BUT IT'S AGAIN UNSATISFYING. AND DEEP LEARNING PROJECT AT THIS POINT. WE HAD A HYPOTHESIS THAT THIS WAS ONLY POSSIBLE THERE WAS INFORMATION HIGH FREQUENCY SPECIAL INFORMATION EMBEDDED IN THIS SPECTRAL DOMAIN OCT. WE TOOK THE NEXT STEP WHERE WE APPLY A GALSION KERNAL ACROSS OCTB STANDS AND LOOK TO SEE WHAT HAPPENED TO THE PREDICTION. ALMOST IMMEDIATELY, THE FLOW IN THIS SMALLER VESSELS DISAPPEARED. THERE WAS THIS VERY NICE SIGMOIDAL RELATIONSHIP BETWEEN FIDELITY OF BEING ABLE TO RECONSTRUCT OCTA WITH THE SIZE OF THE GALLION KERNAL. SO THIS IS EXCITING BECAUSE OCTA HAS NO T BEEN AROUND THAT LONG BUT THERE'S MOUNTAINS OF OCT DATA BEING COLLECTED AND WHAT IF WE COULD USE THESE METHODS TO ENHANCE PAST DATA SETS. HOPEFULLY IN THE FUTURE ENHANCE OCTA ACQUISITION ITSELF. WE TOOK THIS BODY OF RESEARCH AND APPLIED IT IN BRAIN NEUROIMAGING SO WE WERE ABLE TO TAKE T 1 AND T 2 WEIGHTED MRI. IMAGINE OF THE BRAIN AND RECONSTRUCT THE MRA. WITHOUT DOING AN MRA ACQUISITION PROTOCOL. AND WE ALSO APPLIED IT IN DIFFUSION SENSOR IMAGING WHERE WE ARE ABLE TO RECONSTRUCT MAPS OF THE BRAIN USING STANDARD NEURAL IMAGING WITHOUT DOING DIFFUSION TENSOR IMAGING. THIS BODY OF RESEARCH GETS AT THIS IDEA THAT MAYBE THERE ARE UNSEEN SPATIAL FEATURES EMBEDDED IN CONVENTIONAL IMAGING THAT WE ARE NOT PAYING ATTENTION TO. IF YOU TIE TO A STRUCTURAL -- FUNCTIONAL MEASUREMENT, MAYBE DEEP LEARNING CAN TEASE THINGS OUT. I WANT TO TALK LAST SECTION DISEASE MODELING. I'M GOING TO SHIFT GEARS AND TALK GLAUCOMA, HOPE ANY EVERYONE IN THIS ROOM MOWS IT'S A BIG PROBLEM. THERE'S A LOT OF DIFFERENT KINDS OF TESTS THAT ARE AVAILABLE THAT'S OCT VISUAL FIELDS, ET CETERA BUT KEY MISSING COMPONENT RETINA SPECIALIST. AS AN OUTSTANDING LOOKING IN TO THE FIELD WAS THAT THERE WAS A LACK OF PREDICTED ALGORITHMS. THIS IS IMPORTANT FOR DOING RISK STRATIFICATION GLAUCOMA. THINKING HOW YOU CAN USE DEEP LEARNING AND GLAUCOMA HOW YOU CAN DO IS TALK PAIRS OF VISUAL FIELDS AND SEND IT TO EXPERTS. AND ASK THEM DID PROGRESSION OCCUR? AND ROOM OF EXPERTS WE GET IN AND TRY TO REACH CONSENSUS ON THAT. BUT I WANT -- I WAS CURIOUS TO SEE IF THERE WAS A MORE OBJECTIVE WAY WE CAN TRAIN THESE MODELS. WHAT WE DECIDED TO DO, I REALIZED THE ARROW IS SORT OF UNDENIABLE GROWTH TRUTH. WHAT I MEAN BY THAT IS IF YOU TAKE A VISUAL FIELD THIS TIME POINT AND TAKE A VISUAL FIELD AT ANOTHER TIME POINT I KNOW EXACTLY TWO AND A HALF YEARS LAPSE IN BETWEEN THEM. SO WHAT WE TRY TO DO IS SET ONE VISUAL FIELD AS INPUT INTO THE MODEL. AND THE OTHER VISUAL FIELD AS OUTPUT. TRY TO GET DEEP LEARNING TO PREDICT WHAT THE FIELD LOOKS LIKE TIME POINT IN THE FUTURE. SO AGAIN WE HAD TO GO COLLECT THE DATA SET AND WE COLLECTED DATA SET FROM UNIVERSITY OF WASHINGTON, 32,000 VISUAL FIELDS ACROSS 20 YEARS. THAT ENDED UP BEING 1.7 MILLION END POINTS. THE GOAL IS TO FEED ONE VISUAL FIELD IN AND PREDICT FUTURE VISUAL FIELD. I KNEW THIS RESEARCH WAS GOING TO BE A LITTLE BIT CON CONTROVERSIAL SO WE ADOPTED A STRICT METHODOLOGY. SO SOON AS WE GOT VISUAL FIELDS WE DIVIDED 20% AT PATIENT LEVEL OUT AS TEST SET, ONLY TESTED ONCE AT THE END. THE OTHER 80% DID TENFOLD INTERNAL CROSS VALIDATION. TO DO ALL THE MODEL DEVELOPMENT AND EVERYTHING. AND USUALLY IN DEEP LEARNING YOU ADOPT ONE OF THESE TWO METHODS, NO T BOTH BUT WE ADOPTED BOTH TO BE STRICT. AND THESE ARE RESULTS THE UPPER LEFT IS A SCATTER PLOT SHOWING VISUAL FIELD MEDIATION. THE SIZE OF THE CIRCLE REPRESENTS HOW MUCH TIME HAD ELAPSED BETWEEN THE PAIR. THE COLORING IS HOW THE MEDIATION OF INPUT VISUAL FIELD, THE UPPER RIGHT IS A SAME RESULT. ON THE BOTTOM IS THE MEAN POINT WISE ABSOLUTE ERROR AS YOU TRY TO PUSH THE MODEL TO PREDICT FURTHER INTO THE FUTURE. HONESTLY ABOUT FIVE AND A HALF YEARS THE MODEL BROKE DOWN. WE DID WORK IN THE PAPER TO COMPARE AGAINST OTHER LINEAR MODELS AND WE SHOWED DEAN LEARNING WAS SUPERIOR TO THEM. WE ALSO DID A DERIVATION OF AND TRY AND FIGURE OUT WHAT THE LOWER THEORETICAL LIMIT WAS, IT WAS AROUND 2.32-DECIBELS. I THINK SEEING IS BELIEVING. HERE IS INPUT VISUAL FIELDS ON THE LEFT COLUMN, THE ARROW REPRESENTS HOW MUCH TIME ELAPSED BETWEEN THEM AND MIDDLE COLUMN IS THE ACTUAL VISUAL FIELD. FAR RIGHT IS AI DEEP LEARNING PREDICTION. ONE NEGATIVE CONTROL FOR NEUROLOGIC FIELD. WE WOULDN'T EXPECT THOSE TO PROGRESS OVER TIME. WE ALSO DID STRATIFIED ANALYSIS BY SEVERITY OF GLAUCOMA AND WE WERE GLAD TO SEE IT DIDN'T COMPLETELY BREAK DOWN IN SOME OF THE UNDER-REPRESENTED GROUPS IN THE DATA SET. YOU CAN TAKE A SINGLE VISUAL FIELD AND ASK THESE MODELS TO FIEF YOU PROJECTION OF WHAT IT WILL LOOK LIKE IN ONE YEAR, TWO, THREE, FOUR FIVE YEARS AND COMPARE THEM TO HOW THEY OCCUR. I GET A LOT OF QUESTIONS ABOUT THIS, I GET QUESTIONS HOW IS THIS POSSIBLE, DOES THIS PLY INTO FACE OF EVERYTHING WE UNDERSTAND ABOUT VISUAL FIELDS. YES, VISUAL FIELDS ARE UNRELIABLE AND THERE'S ALL SORTS OF RELIABILITY METRICS. WE DIDN'T FILTER THOSE OUT. WE WANTED TO KNOW HOW MUCH THE MODELS COULD LEARN FROM INHERENTLY NOISY DATA. IF I TURN IT AROUND AND ASK GLAUCOMA SPECIALISTS, I ASK THEM DO YOU BELIEVE CERTAIN FIELD CHANGES ARE PREDICTABLE OR CERTAIN CHANGES PRE-DISPOSE TO OTHER CHANGES THEY SAY YES. I BELIEVE THAT. SO IF THE ANSWER TO THAT QUESTION IS YES, THAT'S WHAT THIS BODY OF RESEARCH IS EXPLOITING. OVERALL WE ACHIEVED 2.47, THIS WAS TO SET THE BAR OF WHAT'S POSSIBLE. IN THE FUTURE WE LOVE TO INCLUDE THINGS LIKE OTHER CLINICAL VARIABLES LIKE PRESSURE MEDICATION, CIRCULAR INTERVENTION, IT IS KIND OF INTERESTING HOW WELL IT'S ABLE TO PREDICT. AND IN THE FUTURE REALLY INTERESTING TO BE ABLE TO TAKE A VISUAL FIELD AND ASK WHAT IS THAT VISUAL FIELD LOOK LIKE IF I GET -- DO A TRAV OR TWO, ET CETERA. THE LAST BIT OF WORK TO HIGHLIGHT IS SOMETHING THAT'S ADMITTEDLY PRELIMINARY BUT I'M VERY EXCITED. IT'S A COLLABORATION WITH -- UAB. THEY HAVE DONE A BODY OF WORK AROUND ADAPTATION THEY HAVE SHOWN IT'S AN IMPORTANT FUNCTIONAL MEASUREMENT MANY THE COMPLEX OF MACULAR DEGENERATION. SO WHAT WE TRIED TO DO IS ANSWER A QUESTION OF WHAT FEATURES ON OCT ARE MOST ASSOCIATED WITH OUR MDA. TO DO THIS WE TOOK OCTB SCAN AND WE SLICE THEM INTO TINY VERTICAL WINDOWS AND KEPT TRACK OF A SCAN POSITION. WE TRIED TO LIMIT DEEP LEARNING TO LOOK AT JUST AT THAT WINDOW AND PREDICT WHAT THEY ARE SHOULD BE. GIVEN A PARTICULAR INFORMATION FROM A PARTICULAR PATIENT PREDICT THE ARNDA. SO THIS IS A THOUSAND FOOT SCHEMEIC OF WHAT'S GOING ON. WHAT WE WERE ABLE TO SHOW IS DIFFERENT A SCAN POSITIONS, THE MODEL IS ABLE TO DO THIS TASK DIFFERENTLY, THE CAPACITY TO LEARN THIS TASK DIFFERENCE AT DIFFERENT A SCAN LOCATIONS. THESE ARE ON THE LEFT TRAINING CURVES WE PLOT ALL THE TIME IN DEEP LEARNING. THE IMPORTANT ONE IS TO LOOK ON THE GRAPH OF THE RIGHT. THERE IN VALIDATION SET, THE MODEL WAS ACTUALLY ABLE TO PERFORM BETTER IN THE ORANGE A SCAN LOCATION COMPARED TO BLUE A SCAN LOCATION. TO MAKE SURE THIS WASN'T NOISE WE REPEATED THE EXPERIMENT TEN TIMES AT EVERY A SCAN LOCATION. WHAT WE DID IS WE THEN COLLECTED THE LOWEST POSSIBLE VALIDATION MSC AT EACH A SCAN AND PLOTTED IT. WHEN WE PLOT YOU GET THIS RELATIONSHIP. I FIND THIS TO BE COMPLETELY INTERESTING AND BAFFLING. IF THE NULL HYPOTHESIS IS TRUE YOU EXPECT IT TO BE A STRAIGHT LINE GOING ACROSS MEANING FROM IS NOT NECESSARILY MORE INFORMATION ONE PART B SCAN COMPARED TO ANOTHER PART OF THE B SCAN BUT THERE'S SOME SORT OF RELATIONSHIP. I WAS SHOWING THESE PRELIMINARY RESULTS TO CHRISTINE WHO THEN SENT ME THIS SLIDE THAT SHE HAD POSTULATED, THAT THIS MIGHT LOOK LIKE, THAT THERE WAS A MIXTURE OF TWO DIFFERENT GALSIONS THAT MIGHT BE INDICATIVE OF PROTECTION AND OUR NDA SO INDEPENDENTLY SHE HAD KIND OF HYPOTHESIZE THIS, SHE NEVER SHARED THAT HYPOTHESIS WITH ME A PRIORI BY THE WAY. WHAT'S MORE EXCITING IS THAT YOU CAN APPLY VISUALIZATION TECHNIQUES SOMETHING LIKE THE BALL AND THE DOG THING I SHOWED EARLIER IN THE PRESENTATION. YOU CAN DO THAT TO FIND WHERE IN THE OCTB SCAN MODEL IS LOOKING TO FIND THE RNTA. WHAT IS EXCITING IS WE WERE ABLE TO -- WE FOUND THAT THE MODEL WAS LOOKING IN AREAS THAT ARE NOT TRADITIONALLY DESCRIBED. TRADITIONALLY WITH OCT IMAGES OF RETINA PEOPLE SPEND TIME TALKING ABOUT THE HYPERREFLECTIVE BANDS AND NOT HYPOREFLECTIVE BANDS. SURPRISINGLY THE MODEL SEEMED MUCH MORE INTEREST IN HYPOREFLECTIVE AREAS BETWEEN HYPERREFLECTIVE LUNGS THAN WE THOUGHT BEFORE. SO WE ARE DOING SOME WORK TO VALIDATE THAT NOW. MORE GENERALLY, I THINK THIS FRAMEWORK IS REALLY INTERESTING BECAUSE IT ALLOWS US TO TAKE AGAIN, A GROUND TRUTH THAT WAS NOT DERIVED BY AN AN EXPERT AND THEN USE A CONVENTIONAL IMAGING TO TRY AND TEASE OUT SOMETHING NEW AND SOMETHING WE DIDN'T UNDERSTAND BEFORE. THE LAST TWO SLIDES ARE ABOUT WHY I THINK AI HAS BEEN IMPORTANT FOR EYE CARE AND VISION SCIENCE. DEEP LEARNING CAN HELP WITH HYPOTHESIS GENERATION, HELP EXPLORE THAT SPACE. I DIDN'T TALK ABOUT CLASSIFICATION DIABETIC RETINOPATHY BUT THERE'S WORK DONE ARE THERE AND FDA APPROVED ALGORITHM THAT WILL BE CHANGING THE WAY WE DELIVER CARE IN SCREENING. IN VISION SCIENCE IN PARTICULAR WE HAVE LOTS OF WAYS OF IMAGING NON-INVASIVE NOT ONLY JUST STRUCTURAL IMAGING BUT ALSO FUNCTIONAL DATA. IT ALLOWS US TO DO THE KINDS OF THINGS I WAS DOING WHERE YOU TAKE A FUNCTIONAL MEASUREMENT AND TIE IT TO STRUCTURE AND TRY TO UNDERSTAND WHAT BRIDGES THOSE TWO. MORE IMPORTANTLY COMPARED TO FIELD OF RADIOLOGY PATHOLOGY, DERMATOLOGY WE HAVE VERY DISCRETE DATA FIELDS IN OUR EHR. ALL THE WORK THAT'S WITHIN DONE IN INFORMATICS IS IMPORTANT TO POWER DEEP LEARNING. ONE REASON WE ARE SEEING EXPLOSION OF IS DEEP LEARNING ARTICLES IN THE LITERATURE IN VISION SCIENCE IN OPHTHALMOLOGY IS BECAUSE OF THE FACT. THEY ARE NOT EMBED IN RADIOLOGIST OR PATHOLOGIST REPORT SO I WOULD ARGUE SO THERE'S NO OTHER FIELD OF MEDICINE THAT HAS BREADTH AND DEPTH OF THE IMAGING WITH DISCREET LABELS LIKE WE DO IN OUR FIELD. IF I CARTED THIRDING ABOUT WHAT ARE MISSING PIECES WHY -- WHAT WOULD IT TAKE TO PUSH THIS TO THE NEXT LEVEL, IT'S -- THERE NEEDS TO BE MORE PEOPLE LIKE ME. PEOPLE ACROSS DOMAIN EXPERTS WHO ARE BOTH CLINICALLY TRAINED AS WELL AS DATA SCIENTISTS WITH MACHINE LEARNING BACKGROUND. WHETHER THAT'S HAPPENING IN THE MEDICAL STUDENT LEVEL OR POST-DOCTORAL LEVEL. THERE'S MORE WORK TO BE DONE WITH DATA CURATION STANDARDIZATION SHARING ANNOTATION. THOSE ARE AREAS WE CAN IT RATE ON. FINALLY TO DO THE REALLY CUTTING EDGE MACHINE LEARNING WORK YOU NEED SPECIALIZED COMPUTER HARDWARE THAT I SPENT QUITE A BIT OF MY RESEARCH FUNDS BUYING SO RATHER THAN PIEING ANOTHER PIPETTE OR ANIMAL MODEL, I AM BUYING EXPENSIVE GRAPHICS CARDS. IF THIS HARDWARE IS MORE AVAILABLE IT WOULD ACCELERATE RESEARCH IN THIS AREA. FINALLY, I WANT TO END BY THANKING ALL MY FUNDING SOURCES AS WELL AS MEMBERS OF MY LAB. THANK YOU. [APPLAUSE] >> I HAVE THREE ISSUES. NUMBER ONE THAT MRA MRI TRANSITION, I WONDER IF YOU CAN DO THAT WITH PET SCANS TOO. IT WOULD BE WAY WETTER THAN PET SCANNING PEOPLE. SO THAT YOU GET FUNCTIONAL DATA NOT FLOW DATA BUT FUNCTIONAL DATA MRI IMAGE. ONE SUGGESTION. ANOTHER OBSERVATION IS SOMETIMES THE DATA SET WILL LIE. FOR EXAMPLE, IF YOU LOOK AT IMAGES OF DIABETIC RETINOPATHY AND TREAT WITH ANTI-VEGF AGENTS THE PICTURES GET BETTER BUT IF YOU DO OCTA IMAGES OF THOSE PATIENTS, THE DEGREE OF SO -- THAT'S ANOTHER WAY YOU CAN ADAPT WHAT YOU HAVE DONE TO GET A MORE ACCURATE DESCRIPTION OF HOW MUCH IS THE RETINOPATHY GETTING BETTER BEFORE AND AFTER TREATMENT OPPOSED TO JUST A PICTURE. THEN THE THIRD THING, ONE OF THE EARLIEST THINGS THAT HAPPENS TO PHOTO RECEPTORS WHEN THEY ARE DAMAGED IS OUTER SEGMENT STRUCTURE. YOU CAN MEASURE THAT CLINICALLY WITH DARK ANNOTATION THAT'S A 15 MINUTE TEST. THAT'S FROM A PRACTICAL STANDPOINT, AND POSSIBILITY ONCE WE HAD A BIG SESSION THINKING HOW TO MAKE IT SO YOU CAN DO THIS IN AN INDUSTRIAL LEVEL, WHAT YOU JUST SHOWED SHOULD BE CONVERTED INTO THE OCT VERSION BECAUSE THAT WOULD BE A GREAT WAY TO LOOK AT THE BIOLOGICAL EFFECTS OF DIFFERENT INTERVENTIONS VERY RAPIDLY, SO THAT YOU CAN DO IT TO ALL YOUR -- LIKE IT WOULDN'T REQUIRE SPECIAL ROOM DEDICATED TO GETTING INFORMATION. >> I THINK ALL THREE OF THOSE ARE ENTIRELY WORTH EXPLORING. THERE IS ANOTHER WHOLE SECTION THAT I TOOK OUT BECAUSE DIDN'T HAVE ENOUGH TIME. WHERE WE SHOWED THAT AS ANALOG WITH MICROIMAGERY, WE CAN SHOW WE LOOK AT THE STRUCTURAL OCT SCAN AND PREDICT LOCAL RETINAL SENSITIVITY SO IT SHORT CUTS HOPEFULLY THE NEED TO DO MICRO-- I THINK THAT'S ENTIRELY FEASIBLE AND POSSIBLE TO TRY. I WAS TELLING SOMEBODY BETWEEN THE BREAK FOR EVERY ONE OF THESE PROJECTS THAT I JUST SHOWED YOU THERE'S 20 THAT FAILED. I ALWAYS LIKE TO SAY THAT I THINK IT'S WORTH TRYING, BUT IT'S REALLY IMPORTANT IN THIS BODY OF RESEARCH TO REALIZE THE NULL HYPOTHESIS MAYBE TRUE. MAY NOT BE POSSIBLE TO DO THESE THINGS BUT WORTH TRYING. >> NO OTHER QUESTIONS? >> COMMENT, THANK YOU. THAT WAS BRILLIANT. >> THANK YOU FOR THE OPPORTUNITY TO SPEAK. I WAS EXCITED TO COME. >> WE HAVE A WHOLE BUNCH OF CAPILLARY VIDEO ON PEOPLE WITH DIFFERENT OPTHALMIC PATHOLOGIES AND WE ARE PART OF FAILURE GROUP IN TERMS O TRYING TO USE AI TO DISTINGUISH THEM. I GUESS PART OF THE PROBLEM IS, IS THAT WE DON'T KNOW, IT DOESN'T SEEM AI CAN HANDLE VIDEO VERY WELL. SO WHAT WOULD YOUR STRATEGY BE, WOULD YOU BREAK VIDEOS DOWN? THIS COULD BE A GENERAL QUESTION. VIDEOS DOWN INTO INDIVIDUAL SEGMENT COMPONENTS IN TERMS OF ANALYZING THE DATA. >> THERE ARE A FAMILY OF COMPUTER VISION ALGORITHMS SPECIFICALLY MEANT TO DEAL WITH VIDEOS SO I RECOMMEND TRYING THAT BRANCH OF COMPUTER VISION RESEARCH. YOU CAN CERTAINLY BREAK THEM DOWN INTO INDIVIDUAL FRAMES. THEN USE THOSE AS INDIVIDUAL TRAINING EXAMPLES. ONE THING I WOULD CAUTION YOU AGAINST IS MAKING SURE TO EVADE PATIENT LEVEL PARTITIONING ACROSS YOUR TRAINING VALIDATION AND TEST SETS BECAUSE THE SIMILARITY BETWEEN THE FRAMES WOULD MAKE YOU MIGHT BELIEVE MAKE YOU BELIEVE THE MODEL IS GOING QUITE WELL WHEN IT'S NOT ACTUALLY LEARNING ANYTHING USEFUL. OTHERWISE KNOWN AS (INAUDIBLE). OVERFITTING. >> CAN I JUMP IN HERE? THIS IS CHRIS. >> SURE. >> AARON, BEAUTIFUL TALK. IN THINKING SORT OF ABOUT THE BEST WAY TO DEPLOY DEEP LEARNING ACROSS THE BROADER FIELD, SEEMS THAT HAVING EVERY UNIVERSITY REPLICATE A DEEP LEARNING GROUP COMPUTATIONAL INFRASTRUCTURE WHICH IS NOT TRIVIAL TO DO THIS SORT OF WORK WOULD RESULT IN A LOT OF DUPLICATION OF EFFORT. ALMOST SEEMS AS IF THEY -- A LOT OF THE RESEARCH TEAMS ARE AGNOSTIC TO THE PROBLEM, AS LONG AS IT HAS RICH ENOUGH DATA SET, INTERESTING, DO YOU SEE THE POTENTIAL FOR SORT OF THROUGH NEI FUNDING MECHANISM OR SOMETHING LIKE THAT, A CONSORTIUM TYPE APPROACH IN WHICH YOU WOULD HAVE THESE TEAMS WHO COULD BID OUT ON SPECIFIC PROBLEMS RESEARCHERS HAVE OPPOSED TO HAVING DEVELOP THIS EXPERTISE DE NOVO EVERY TIME? >> RUSS, IS THAT A QUESTION FOR ME? >> START WITH YOU AARON, JUST IN TERMS OF YOUR SENSE OF HOW BROAD EXPERTISE IS AVAILABLE AND YOUR HONOR WISH LIST AS SOMEONE WITH CAPACITY TO DO THESE SORTS OF THINGS, WOULD YOU LIKE PEOPLE TO BRING FORTH PROJECTS THAT HAVE RICH DATA SETS POTENTIALLY SOLVABLE OR SHOULD IT BE CLONED IN MANY SITES AND DONE MORE LOCALLY? >> I THINK ONE OF THE REALLY AMAZING THINGS ABOUT DEEP LEARNING IS THAT IT'S FORCED PEOPLE TO WORK TOGETHER. NO ONE INSTITUTION HAS LARGE OR DIVERSE TRAINING SET TO BUILD TO TRAIN THESE MODELS. SO IT FORCED PEOPLE TO DEAL WITH SOME OF THE ISSUES AROUND STANDARDIZATION. BUT ALSO TO COME TOGETHER TO WORK TOGETHER. IT WOULD BE MUCH BETTER IN TERMS OF HUMAN EFFORT TESTIFY PEOPLE WERE DOING CONSORTIUM TYPE APPROACH. I WILL SAY THAT IN TERMS OF EXPERTISE, EVERY ONE OF THESE PEOPLE ON THE SLIDE HERE THEY CRASH OUT OF INDUSTRY. DOING MACHINE LEARNING FOR AMAZON OR FINANCIAL INSTITUTION. THEY DECIDED IT WAS NOT WORTH THEIR EFFORT AND THEY WANT TO DO SOMETHING MORE MEANING SO CAME TO WORK IN OUR LAB. BUT FINDING THOSE PEOPLE HAS BEEN A NIGHTMARE. IT'S REALLY HARD TO FIND THESE PEOPLE. IF IT WOULD MAKE MORE SENSE IF WE BUILT CONSORTIUM TYPE APPROACH. THANK YOU. [APPLAUSE] >> FINALLY, JERRY GETS A CHANCE. DISEASE WUJEK IS OUR SMALL BUSINESS PORTFOLIO PROGRAM PERSON AND HE WILL SPEAK TODAY ON SBIRs AND STTRs. DR. WUJEK. >> I WASN'T LYING ABOUT THE -- PART. THERE WE GO. FROM THE BEGINNING. CAN EVERYBODY HEAR ME OKAY? I'M INJURY WUJEK. I MANAGE OR TRY TO MANAGE THE NEI SMALL BUSINESS PROGRAM. THIS IS A BIT DIFFERENT. IT'S QUITE A BIT DIFFERENT FROM MOST GRANT MECHANISMS BECAUSE AS YOU CAN SEE IT'S FROM APPLICATION TO COMMERCIALIZATION. THIS IS A GRANT MECHANISM AND I WILL TELL YOU MORE ABOUT IT, I CAN TAKE ABOUT HALF A DAY AND TALK ALL ABOUT IT, ANNIE ONLY GAVE ME 45 MINUTES SO I WILL TRY TO MOVE THROUGH IT QUICKLY AND GIVE YOU AN OVERVIEW OF WHAT SMALL BUSINESS DOES, ITS PROCESS, ITS SUCCESS, HOW IT'S BEEN CHANGING OVER THE YEARS. I HAVE BEEN AT NEI SINCE 2006, TIME FLIES WHEN YOU ARE HAVING FUN. QUICK OVERVIEW WHAT IT IS. HOW IT WORKS EVOLUTION OF THE PROGRAM SINCE 2006 WHEN I JOINED. AND LOOKING TO THE FUTURE. SOME PEOPLE CALLED IT AMERICA'S SEED FARM. FROM THE LARGEST SOURCES OF EARLY STAGE CAPITAL FOR SMALL BUSINESSES. EARLY STAGE IS VERY IMPORTANT. WE ARE FUNDING COMPANIES VENTURE CAPITALISTS AND ANGEL CAPITAL PEOPLE WILL NOT LOOK AT. THEY SAY COME BACK WHEN YOU HAVE HUMAN DATA OR SOMETHING LIKE THAT. IT SUPPORTS USA COMPANIES, THAT'S ELIGIBILITY REQUIREMENT. IT CREATES INNOVATIVE HIGH RISK HIGH PAY OFF TECHNOLOGIES THOUGH I WILL SAY HIGH PAY OFF IN QUOTE BECAUSE WE ARE INTERESTED IN NICHE METHODS, WE HAVE A COMPANY CALLED DANCING DOTS. WE GAVE THEM A GRANT BUT COMPANY IS OWNED AND OPERATED BY A BLIND MU SIGNATURES AND HIS PRODUCT IS -- MUSICIAN AND HIS PRODUCT IS SOFTWARE FOR BLIND MUSICIANS TO READ MUSIC AS THEY ARE PLAYING. BRAILLE AND PLAYING A PICK LOW IS A LITTLE CHALLENGING IF NOT IMPOSSIBLE. THAT'S A VERY SMALL MARKET. BUT OF COURSE MARKET IS A BIG PART OF THE IT. COMMERCIAL PROMISE M. NOT LOOKING FOR SCIENCE AND TECHNOLOGY IS FOUNDATION BUT THE END POINT IS SALES. MORE THAN SALES. WE ARE THE NIH NEI LOOKING FOR HEALTH AND SAVE LIVES. THAT'S ANOTHER -- WHY WE ARE INTERESTED IN SMALL MARKETS. BECAUSE ONE OF THE FIVE REVIEW CRITERIA, BRINGING BACK CSR INTO THE TOPIC IS SIGNIFICANCE. I TELL MY APPLICANTS, IT'S NOT NECESSARILY SIGNIFICANCE OF YOUR PROBLEM. IT'S A SIGNIFICANCE OF YOUR SOLUTION. TO A PROBLEM. SMALL BUSINESS, TWO SEPARATE PROGRAMS, ONE IS SMALL BUSINESS INNOVATION RESEARCH REVIEWERS AT STUDY SECTION WILL SAY INNOVATION IS PART OF THE TITLE, THE OTHER IS SMALLER SMALL BUSINESS TECHNOLOGY TRANSFER. AS THE TITLE SUGGESTS, TECHNOLOGY TRANSFER, FROM NON-PROFIT RESEARCH INSTITUTIONS, SMALL BUSINESSES TO GET TO IT THE MARKETPLACE. STTR. SO I WILL BE TALKING SBIR AND STTR. THESE HAVE BEEN CONGRESSIONALLY MANDATED SO IT'S THE LAW. EVERY LARGE FEDERAL AGENCY, IN PROGRAM FEDERAL LIVE FROM DOD DOWN TO DEPARTMENT OF EDUCATION. MENT DOD IS 3 HUP POUND GORILLA IN TERMS OF AMOUNT OF MONEY, HHS WE ARE PART OF IS SECOND. SBIR IS ESTABLISHED IN 1982. THERE IS A LONG HISTORY HERE. STTR WAS ESTABLISHED IN 1992, CONGRESS WANTED TO HELP MOVE THINGS FROM BENCH TO BEDSIDE AS IT WERE. THIS IS A LAW PERIODICALLY REAUTHORIZED OR CURRENT THROUGH REAUTHORIZED LIEU FISCAL YEAR 2022. PERIODICALLY REAUTHORIZED. WHAT DOES THAT MEAN? EVERY NOW AND THEN THE RULES CHANGE AS WE PLAY THE GAME. FROM ARE THE THINGS DO CHANGE, DYNAMIC, KEEPS US INTERESTING. FEDERAL WIDE, IT IS A SMALL BUSINESS ADMINISTRATION, THAT SETS THE POLICY. SO THE RULES REGULATIONS AND LAWS THAT WE HAVE TO FOLLOW ADMINISTRATING AND DOING THIS PROGRAM. THE TWO PROGRAMS THEY ARE SEPARATE. DR. STEINMETS CANNOT MIX THE MONEY BETWEEN THE TWO, NEI HAS 21 MILLION FOR SPIR AND SBIR ONLY. S TEXASR IS -- STTR IS SMALLEST 3 MILLION, WE GET FEWER GRANT APPLICATIONS STTR. IT'S ALL ABOUT THE SAME. THERE ARE SIMILARITIES AN DIFFERENCES BETWEEN THE TWO PROGRAMS. BOTH ARE PRIVATE SECTOR COMMERCIALIZATION, GETTING THINGS TO THE MARKETPLACE, STIMULATING PATHOLOGICAL INNOVATION. OVER THE LAST FEW DECADES, PHARMACEUTICAL INDUSTRY A LOT, EVEN OTHER PARTS OF HEALTH INDUSTRY WHERE IS THE INNOVATIVE COMING FROM? SMALL BUSINESSES. LARGE PHARMA, THEY HAVE DEEP POCKETS FOR CLINICAL TRIALS. THE DIFFERENCE IS, STTR, LET'S START WITH SBIR. SMALL BUSINESS CAN DO THE WHOLE WORKS. 100%. STTR, THERE IS A REQUIRED PARTNERSHIP BETWEEN SMALL BUSINESS AND RESEARCH INSTITUTION. MIAMI UNIVERSITY, HARVARD UNIVERSITY. ET CETERA. ET CETERA. UCLA. UNIVERSITY OF WASHINGTON. SO IT'S A COOPERATIVE RESEARCH THAT REQUIRES STIMULATING TECHNOLOGY TRANSFER. WE ARE VERY CREATIVE HERE IN THE SMALL BUSINESS PROGRAM, SOMETIMES IT'S SMALL BUSINESS THAT HAS TECHNOLOGY, WHAT THEY NEED FROM THE UNIVERSITY IS EQUIPMENT SUPPLIES, EXPERTISE. THEY CAN PROVIDE. ELIGIBILITY WHO CAN APPLY? IT HAS TO BE A FOR PROFIT USA BUSINESS. YOU WOULD BE SURPRISED ISN'T FOR PROFIT AND BUSINESS THE SAME THING? NOT ALWAYS, I DO GET APPLICANTS CALLING AND SAYING I HAVE A NON-PROFIT, CAN I APPLY? NO. SO HAS TO BE SMALL, 500 OR FEWER EMPLOYEES. MOST OF THE COMPANIES ARE IN THE RANGE OF TWO PEOPLE TO 20 PEOPLE TO 50 PEOPLE. MANY ARE STARTUPS, SOME DIDN'T EXIST LAST YEAR. THE R&D WORK MUST BE DONE IN THE USA. THAT'S ANOTHER KEY POINT. THE MARKETPLACE IS LOCAL. ONCE YOU HAVE GOT YOUR PRODUCT R&D, WE HAVE GOTTEN YOU THERE, THEN YOU CAN SELL IT ANYWHERE AS YOU WILL SEE IN THE EXAMPLES I WILL PROVIDE. LASTLY, INDIVIDUAL OWNERSHIP THIS IS ONE OF THOSE THINGS DEVIL IS IN THE DETAILS, I WON'T BORE YOU WITH DETAILS. BUT THAT'S AN IMPORTANT THING. VENTURE CAPITAL COMPANIES CAN'T GO IN SMALL BUSINESS. THE GOAL IS COMMERCIALIZATION. THERE'S LOTS OF WAYS TO DEFINE COMMERCIALIZATION. I WILL TALK ABOUT THAT IN A MOMENT. THE SIMPLEST DEFINITION I FOUND CALLS LOTS OF DIFFERENT DEFINITIONS. PROCESS OF MAYBEING A NEW PRODUCT. A NEW PRODUCTION METHOD OR NEW SERVICE. TELEMEDICINE. AVAILABLE FOR SALE TO THE PUBLIC. FINDING COMMERCIAL SUCCESS HERE AT NIH, I'M MIXING NIH AND NEI A LITTLE BIT AS WE GO THROUGH BECAUSE SOME OF THE PROGRAMS SOME OF THE THINGS WE DO HERE ARE UNIQUE TO NE I. WE ALSO HAVE AVAILABLE TO OUR NEI SMALL BUSINESS PROGRAM SOME OF THE NIH WIDE RESOURCES. I TAKE ADVANTAGE OF THOSE. HOW DO WE DEFINE COMMERCIAL SUCCESS. WHILE SALES IS AN OBVIOUS THING, SELLING YOUR OWN PRODUCT BUT THIS CAN BE A LONG WINDING ROAD BECAUSE PRODUCTS HAVE TO GO THROUGH THE FDAMENT THAT CAN TAKE A LONG TIME. LICENSING AGREEMENT OR PARTNERSHIPS. WE HAVE SOME COMPANIES THEY MAKE A COMPONENT SELL IT TO A MANUFACTURER, YOU WILL NEVER SEE THAT COMPANIES NAME ON A PRODUCT. IT'S IN THERE MAKING IT WORK. MERGER OR ACQUISITION. BEFORE I DO THIS ONE I'LL STEP BACK, PARTNERSHIPS, STRATEGIC PARTNERSHIPS. I TELL COMPANIES SBIR WE FUND PROJECTS, WE DON'T FUND COMPANIES BETWEEN GRANTS AND OVER THE LONG HAUL GET TO MARKETPLACE YOU GOT TO HAVE THE WHEREWITHAL TO KEEP YOURSELF GOING, KEEP YOUR EMPLOYEES PAID. KEEP THE PROJECT MOVING FORWARD. STRATEGIC PARTNERS SHIPS,ES SERIES A, SERIES B FINANCING, THOSE ARE KEY STEPS. THAT MEANS SOMEBODY PUT A CROWBAR TO THEIR WALLET AND GIVEN YOU MONEY BECAUSE THEY THINK YOUR TECHNOLOGY WILL WORK. MERGER OR ACQUISITION. THIS IS TRUE FOR THE PHARMACEUTICAL BIOTECH COMPANIES BECAUSE IT TAKES DEEP POCKETS CLINICAL TRIALS MULTIPLE CLINICAL TRIALS NO SMALL -- COUPLE OF EXAMPLES ALSO. THAT'S A COMMERCIAL SUCCESS. AGAIN, SOMEBODY PAID MONEY FOR THAT TECHNOLOGY. THE CLINICAL TRIALS, WE ARE FUNDING SOME SMALL BUSINESSES DEPENDING UPON THE PRODUCT THEY ARE ABLE TO GET TO A CLINICAL TRIAL. IT CAN BE FIRST IN HUMAN. VENTURE CAPITAL A LOT TO SAY, WE WOULD LOVE TO FUND IT BUT SHOW ME SOME HUMAN DATA FIRST. WE CAN HELP THEM GET THERE. A QUICK NOTE OVER THE YEARS WE HAVE HAD OVER 40 COMPANIES THAT ACHIEVED SOME FORM OF COMMERCIAL SUCCESS AT NEI. IT'S DOING QUITE WELL, I LIKE THE THING. SO HOW IT WORKS LICENSING AND SALES. THIS IS ONE EXAMPLE. THIS IS A DICES DOES EVERYBODY HAS GONE TO THE -- (INDISCERNIBLE). EVERYBODY HAS GONE TO THE EYE DOCTOR, BIG MACHINES, DOES THIS LOOK BETTER, DOES THIS LOOK WORSE, DOES THIS LOOK BETTER OR WORSE? (INDISCERNIBLE) DEVELOPED AN AUTOMATED MOBILE TOOL,S ONE FIRST PRODUCT IS A QUICK SEAT. THEY CAME IN WITH A PHASE 1 GRANT. I WILL BE TALKING MORE PHASE 1 PHASE 2 A LITTLE BIT. BUT EARLY GRANT THEY DEVELOPED A ALREADY BASIC SYSTEM RYE SENSING AGREEMENT -- LICENSING WITH ORAL LAB IN INDIA, MARKETPLACE IS LOCAL. THEY HAVE SOLD THEIR TECHNOLOGY LICENSED IT TO THE ORAL LAB AND ORAL LAB IS SELLING THE EC IN INDIA. LOW TRAINING ALMOST EVEN TECHNICIANS CAN DO IT. VERY GOOD BUT NOW THEY ARE LOOKING TO SELL IT IN AMERICA. THIS IS A MORE -- AND IN THE ERA SO MORE SOPHISTICATED MARKET. SO USING A PHASE 2 GRANT TO EXTEND FUNCTIONALITY TWO OF THE ASPECTSTHEY ARE LOOK FOR IS ENHANCE ASIGNATUREMATIC OPTICAL POWER, NOT JUST BASIC PRESCRIPTION BUT ACTUALLY A VERY COMPLEX SOPHISTICATED JUST LIKE THAT. ANOTHER ONE, THIS IS ACTUALLY A DOUBLE EXAMPLE BY OPTOGEN IN DURHAM, NORTH CAROLINA. OCULAR COHERENCE TOMOGRAPHY, THE OCT AARON WAS TALKING ABOUT. THEY GOT IN EARLY IN THE GAME. IT'S A SMALL BUSINESS AND OCT NON-INVASIVE GREAT IMAGING TECHNIQUE MICRON RESOLUTION EXAMPLES IN THE UPPER RIGHT CROSS SECTIONAL, THEY DO 3-Ds, THEY DEVELOP AND SOLD IN THE MARKET THEIR OWN SYSTEM AND SEVERAL INNOVATIVE PEDIATRIC, IT'S CHALLENGING BECAUSE YOU HAVE YOUNG KIDS HARD TO -- THEY ARE NOT ALWAYS COOPERATIVE. A HAND HELD OCT, IN VARIOUS SITUATIONS MORE AFFORDABLE. INTRASURGICAL OCT. THIS IS VERY INSTRUMENTAL AND WILL EVENTUALLY HAPPEN BUT NORMALLY IF YOU HAVE DONE ANY SURGERY LOOKING THROUGH A SCOPE YOU SEE WHAT'S ON THE SURFACE. SURGEON BY EXPERIENCE LOOKS WHAT'S UNDERNEATH BUT INTRASURGICALLY YOU CAN SEE SOME OF THE LAYERS AS YOU ARE OPERATING ON THE RETINA. THAT ALLOWS YOU TO TAKE THE WHOLE EYE IN ONE SESSION. SO IT WAS RECOGNIZE LEADER IN THE OCT FIELD, I WOULD RUN ACROSS PAPERS AND LOOK IN THE MATERIALS AND METHODS, THEY ARE USING OCT, THEY BOUGHT A (INDISCERNIBLE). THEY ARE SUCH A GOOD LEADER. THEY GOT PURCHASED BY GERMAN COMPANY WHICH ACTS AS SUBSIDIARY OF JAPANESE COMPANY, IN 2015 LIKE MICROSYSTEMS. COMING BACK TO AARON'S TALK. AT THE VERY END DATA MANAGEMENT. THE CEO OF OPTOGEN STARTED NEW COMPANY BECAUSE HE DIDN'T WANT TO WORK IN THAT ENVIRONMENT ANY MORE. HE'S AN ENTREPRENEUR. BUT HE'S GOT A GRANT APPLICATION COMING IN THAT IS DOING ARTIFICIAL INTELLIGENCE DATA MANAGEMENT AND ALL OF THESE THINGS THAT AARON WAS TALKING ABOUT. SO THE CONSORTIUM QUESTION AT THE END WE MAYBE ABLE TO ANSWER THAT FOR YOU. CLINICAL TRIAL. SBIR AWARDED IN 2010, THEY WERE LOOKING AT AN EPITHELIAL SODIUM CHANNEL BLOCKER FOR CHRONIC DIE EYE. THIS IS A COMPANY TRYING TO DEVELOP A DRUG. DEEP POCKETS NEEDED TO GET THROUGH CLINICAL TRIALS. THEY ARE LOOKING AT THE SODIUM CHANNEL BLOCKERS, DRY EYE COMPLEX DISEASE BUT HYDRATION OF EYE SURFACE VERY IMPORTANT. THEY ARE LOOKING TO REGULATE SALT AND WATER TRANSPORT IMPROVING THE HYDRATION OF THE EYE. THEY WERE LOOKING TOTY I KNOW DEVELOP FIND NOVEL MOLL QUEUINGS TO POTENTLY INHIBIT EPIHELIUM SODIUM CHANNELS. DRUGS ARE TRICKY THINGS, THEY HAVE TO BE EFFICACIOUS AND POTENT BUT HAVE TO BE SAFE. AND MANY OTHER THINGS THAT GO WITH IT. WITH OUTSIDE FUNDING AS WELL AS R FUNDING AND THEY ALSO TOOK ADVANTAGE OF ANOTHER RESOURCE THE NIH HAS AVAILABLE WHAT WAS IT CALL IN BASICALLY A RESOURCE COMPANIES AND INVESTIGATORS CAN HAVE ACCESS TO, BASICALLY WE HAVE SUBCONTRACTORS AT NIH THAT DO PHARMACOKINETICS, PHARMACODYNAMICS. SAFETY. METABOLISM. ET CETERA. ET CETERA. FORMULATION. THIS COMPANY WAS ABLE TO TAKE ADVANTAGE OF THAT RESOURCE, COMPETITIVE GRANT APPLICATION. THAT MOVED HIM FORWARD,, DOING CLINICAL TRIALS THEY JUST COMPLETED IT. RESULTS ARE VERY GOOD AND NOW PURSUING NEXT STEPS AND PROBABLY SOON WILL BE BOUGHT OUT IF NOT A LITTLE BIT LATER. BASICALLY RESULTS COME OUT GOOD. THAT'S ALWAYS THE CLINICAL TRIAL IS THE ULTIMATE ANIMAL MODEL UNTIL YOU CAN SHOW IT ALREADY MANY DRUGS WHICH ARE GREAT ALL THE WAY TO THE END. DO THAT CLINICAL TRIAL. DOESN'T WORK. I HAD ONE COMPANY THAT WE DID FUND BUT CLINICAL TRIAL BUT THE RESULTS DIDN'T WORK. SMALL BUSINESS. HOW IT WORKS GRANTS AND RESOURCES, YOU APPLY FOR SMALL BUSINESS GRANT, THE NIH PEER REVIEWS ALL THE SBIR STTR GRANT APPLICATIONS AND THERE ARE STUDY SECTIONS SPECIFICALLY FOR THE SMALL BUSINESS, DR. HARTMAN KNOWS ABOUT THAT. OF COURSE THE FIVE NIH REVIEW CRITERIA ARE APPLIED SOMEWHERE U.S. LIKE ANY OTHER GRANT MECHANISM. THIS IS GREAT UNLIKE VENTURE CAPITAL IT'S NON-DILUTIVE. WE FUND THE COMPANY, BUT AS FEDERAL AGENCY WE CAN'T TAKE AN EQUITY POSITION OR OWNERSHIP POSITION OF THE COMPANY. VENTURE CAPITAL THEY GIVE YOU MONEY. THEY TAKE A PLEASE PIECE OF YOUR COMPANY. UNLIKE PRIVATE INVESTMENTS AND ALSO YOU KEEP INTELLECTUAL PROPERTY AND DATA RIGHTS. IT'S LUCRATIVE VERY ATTRACTIVE RESOURCE TO SMALL BUSINESSES. AND OF COURSE VERY COMPETITIVE. OUR SUCCESS RATE IS RUNNING IN THE 2015 TO 25% RANGE. IT'S GETTING TOUGHER LATELY. THERE ARE A LOT OF COMPANIES, I TELL APPLICANTS THEY ASKED IS MY -- IS MY PROJECT AVAILABLE TO YOU? IS IT WORTHWHILE? ELIGIBLE? IF THE -- IT HAS TO DO WITH NEE NEI SBIR DOES IT. AS YOU WILL SEE. LITTLE BIT MORE HOW IT WORKS. NUTS AND BOLTS, DIFFERENT FROM THE RO1 AND OTHER GRANT MECHANISMS BUT IT IS A STAGED PROCESS. FIRST SMALL BUSINESS PHASE 1 GRANT, THIS IS A FEZZIBILITY STUDY, SMALL AMOUNT SMALL TIME SIX MONTHS, 12 MONTHS, IT'S ABOUT FEASIBILITY, I WILL TALK MORE ABOUT THAT IN A MINUTE. PHASE 2, THAT'S THE FULL RESEARCH AND DEVELOPMENT PROJECT. THAT'S WHERE YOU BEGIN TO OPTIMIZE AND GET THAT STRONG DATA. PHASE 3 ACCORDING TO CONGRESS PHASE 3 COMMERCIALIZATION STAGE IS USE OF NON-SBIR STTR, YOU GOT O GET IT TO THE MARKETPLACE. CRITICAL THING. SMALL BUSINESS PHASE 1 PHASE 2 PHASE 3, NOT THE SAME AS CLINICAL TRIAL PHASE 1, PHASE SOMETIMES CONFUSING TO PEOPLE, PHASE 1, PHASE 2 ROLLS OFF MY TONGUE, PEOPLE SAY OH, CLINICAL TRIAL. NO, NO, NO. IT'S DIFFERENT. PHASE 1 GRANT, ESTABLISHING THE TECHNICAL MERIT AND SHOWING COMMERCIAL POTENTIAL. SO PROOF OF CONCEPT. IT'S A SMALL GRANT YOU HAVE TO ASK THAT, WHAT'S THAT MOST IMPORTANT QUESTION THAT YOU NEED TO SHOW MAKE IT A GO, NO GO DECISION POINT. PHASE 2 THAT IS WHERE YOU BUILD OUT THE PRODUCT. IF IT'S A DEVICE OPTIMIZE DESIGN PROTOTYPE, DRUGS, PHARMACOLOGY EFFICACY, A IN MOST CASES MANUFACTURING ISSUES. PHASE 3 COMMERCIALIZATION STAGE I PUT THAT IN QUOTE BECAUSE I TELL PEOPLE COMMERCIAL PLANNING SHOULD BE FROM THE START. THEY ARE ALWAYS THINKING, THAT'S WHAT I LEARNED WHEN I WAS AT A BIOTECH COMPANY, ONE OF THE JOBS OF THE CEO WAS TO KEEP THESE WONDERFUL SCIENTISTS ON TARGET. HERE IS OUR PRODUCT. THAT'S A NICE LITTLE FINDING. RIGHT IN SBIR, THEN WE'LL THINK ABOUT DOING IT. AGAIN, COMMERCIAL SUCCESS. THIS IS A RECENT ONE, IT'S ONGOING. LUMATHERA. THIS IS A CASE OF SALES OUTSIDE THE USS -- USA, THEY BEGINNING WITH OUR FUNDS FDA APPROVED CLINICAL TRIALS. THEIR PROJECT IS CLINICAL EVALUATION OF INNOCULATION OF DRY MD EYE PATIENTS. THOUGH MITOCHONDRIAL DYSFUNCTION OXIDATIVE STRESS ARE PART OF THE AMD DRY AMD. BIOMODULATION, IT'S USING SPECIFIC LIGHT WAVELENGTH, IN THIS CASE IT ACTIVATES MITOCHONDRIAL CHANGE COMPONENTS. NON-INVASIVE USING LIGHT TO TREAT PART OF THE DISEASE TISSUE, STABILIZES METABOLIC FUNCTION AND STIMULATES MITOCHONDRIAL ENERGY. REMEMBER THE EYE IS A ENERGY DEPENDENT SYSTEM. PHOTO RECEPTORS, ALL THE RETINAL CELLS ARE CONSTANTLY WORKING. SO WHAT THEY HAVE SHOWN IN CLINICAL TRIALS IN CANADA, AND IN EUROPE, AND BEGINNING CLINICAL TRIALS HERE, THE PHOTO -- MY PHOTOBIOMODULATION, CAUSES OR LEADS TO REGRESSION OF DRUZIN, IMPROVING RETINAL FUNCTION AND FOR THE PATIENT BETTER VISUAL ACUITY AND CONTRAST SENSITIVITY. IT'S NOT A CURE, IT LASTS ABOUT SIX MONTHS OR SO, DEPENDS UPON THE PATIENT BUT THEY FOUND THAT PATIENT COMES BACK FOR TREATMENT TWO OR THREE DAYS. TEN MINUTES EACH TREATMENT. YOU GET IMPROVEMENT AGAIN. THERE IS A GET BETTER, GET WORSE COME BACK GET TREATED GET BETTER, BUT THAT'S NOT SO UNUSUAL TO NUMBER OF DISEASES THAT WE ARE TREATING ALREADY. IT'S THE NAME THEY HAVE GIVEN THEIR DEVICE, A LIGHT DELIVERY SYSTEM, IT'S APPROVE IN THE EUROPEAN UNION, CE MARK FOR THOSE WHO MAY NOT KNOW THE CE MARK IS IT'S A VARIATION, QUITE DIFFERENT THAN THE FDA BUT AGAIN REGULATORY PROCESS WHICH MEDICAL PRODUCTS ARE APPROVED IN EUROPE. NOW THEY HAVE INITIATED FDA APPROVED CLINICAL TRIALS. SO THAT SHOULD BE COMING TO AMERICA SOON HOPEFULLY IN THE NEXT FEW YEARS. ANOTHER MECHANISM WE HAVE IS A FAST TRACK. SIMULTANEOUS SUBMISSION AND REVIEW OF PHASE 1 AND PHASE 2 GRANTS. WHY IS THAT NECESSARY? THIS IS USEFUL FOR PROJECT WITH HIGH COMMERCIALIZATION POTENTIAL. BUT WHAT IT DOES NORMALLY IF YOU GO PHASE 1 YOU GET GO THROUGH REVIEW, GET GRANT FUNDING DO THE PROJECT, SUBMIT GRANT APPLICATIONS FOR PHASE 2, NO U YOU GOT TO WAIT NINE, TEN MONTHS TO GET THE MONEY, THAT REDUCES THE GAP BETWEEN PHASE 1 AND PHASE 2. SO PHASE 1 IS AWARDED FIRST. THEN YOU DO THAT PROJECT. YOU SUBMIT PROGRESS REPORT, AND THEN IT'S EVALUATED AND APPROVED. ADMINISTRATIVE REVIEW IN HOUSE, IN THE -- HERE AT NEI FOR OUR GRANTS. SO PHASE 2 IS NOT GUARANTEED. MANY COMPANIES DO GET, ONCE THEY DO A PHASE 1 THEY ARE DOING STRONG WORK. OVER THE YEARS WE FUNDED 28 PROJECTS. FOUR PHASE 1s ARE ACTUALLY INACTIVE RIGHT NOW. WE HAVE HAD TWO GRANTS THAT FAIL TRANSITION. SO IT'S NOT A SLAM DUNK. WE HAD ANY COMMERCIAL SUCCESS? WE'LL COME BACK TO BIOOPTOGEN. THEIR SURGICAL OCT MACHINE STARTED AND INITIATED WITH A FAST TRACK. OF COURSE NOW THEY HAVE BEEN BOUGHT OUT THEY ARE SO SUCCESSFUL. MORE RECENT ONE IS IRIS VISUAL LLC. USING AGAIN, ARTIFICIAL INTELLIGENCE, AND THEY CREATED WEARABLE LOW VISION GLASSES FOR THE/LY IMPAIRED SO IT ACTUALLY USING AI, IT MODIFIES THE SCENE, MAG MY MYS SPECIFIC ASPECTS OF IT AND IT CAN BE WARN, IT'S MOBILE. LIKE THE VIRTUAL REALITY THAT PEOPLE USE NOW. THIRDLY, THIS IS NOT THE ONLY ONE. BUT SCAN INCORPORATED IN NEW ENGLAND, AUTOMATED SCREENING FIRST FOR BUSINESS AND THAT'S THREE VIEWS OF THE DEVICE ABOUT THE SIZE OF A BASKETBALL, SEEMS TO BE QUITE INTRIGUING FOR THE KIDS. WHAT IS UNIQUE AND POWERFUL ABOUT THIS, IT'S AUTOMATED. NORMALLY YOU NEED A LITTLE BIT OF COOPERATION FROM YOUR PATIENT TO REALLY GET DIAGNOSIS OF -- THIS REQUIRES NO COOPERATION SO THEY ARE ABLE TO CHECK AND SCREEN INFANTS AS WELL AS YOUNG CHILDREN. VERY QUICK AND RAPID. THIS IS ANOTHER COMPANY, IT WASN'T FAST TRACK BUT ANOTHER INTERESTING SUCCESS, IT'S ABOUT CATARACTS AND CATARACT SURGERY, INITIALLY, THEIR PROJECT WITH MICROTECHNOLOGY ENHANCE PEDIATRIC LENS CAPSULEOTOMY DEVICE, THIS IS ONE OF THE SMALL MARKETS AGAIN, PEDIATRIC CATARACTS NOT THAT FREQUENT,, BUT IT CAN BE DEVASTATING TO BE BLIND AT VERY YOUNG AGE. CATTED RACKET SURGERY IS VERY -- CATARACT SURGERY IS VERY COMMON SOME CASES PEOPLE CALL IT ALMOST SIMPLE BUT THE FIRST STEP IS CUTTING A CIRCLE IN THE LENS CAPSULE. IN ADULTS, VERY SIMPLE, IT'S GOT -- SURGEONS KNOW, I JUST DO A LITTLE -- IN CHILDREN THAT LENS CAPSULE IS DIFFERENT PHYSICAL CHARACTERISTICS, MORE DIFFICULT TO TEAR. TO MAKE THAT CUT. IS THAT IS THE MOST CHALLENGING PART OF IT. T FAILURE AND SUCCESS CAN HAPPEN BASED ON THAT. CATARACT SURGERY LENS PRECISION IS THE FIRST STEP. AND -- (OFF MIC) A LOT ABOUT THIS. BUT MAKING THAT CIRCULAR IS CRITICAL. AS YOU CAN SEE WE ARE WORKING THROUGH THE CORNEA. THIS IS TECHNICALLY CHALLENGING. A GOAL WAS TO CREATE THE DEVICE THAT WOULD AUTOMATE AND SIMPLIFY THE FIRST MOST DIFFICULT STEP. IN 2011 THEY GOT SMALL BUSINESS PHASE 1 GRANT. WITH THIS THEY ARE ABLE TO DO EARLY PROTOTYPE AND FEASIBILITY. THIS IS VERY COMPLEX SYSTEM THAT THEY ARE CREATING. SO YOU CAN SEE THE SKETCHES THEY HAD, IT COMES OUT FOLDED,S THEY EXTRUDE IT, THE INSTRUMENT POPS OUT AND YOU CAN SEE THAT PURPLE RING. THAT IS THE WORKING PIECE RIGHT THERE. VERY THIN MICROENGINEERING, A ZAP OF ELECTRICITY, GENERATES A LOT OF HEAT, MAKES A PERFECT CIRCULAR CUT IN THAT CAPSULE. AND THE OTHER TRICKY THING, ONCE IT'S OPEN AND DONE IN BUSINESS, THE SERVE AS STRUCTURAL SCHEMATIC YOU HAVE TO GO BACK TO A AND PULL IT BACK IN AGAIN. SO YOU CAN PULL IT OUT OF THE CORNEA. SO BUT 2011 SMALL BUSINESS PHASE 2, THEY OPTIMIZE DESIGN COMPONENT AND SURGICAL PERFORMANCE, THERE YOU CAN SEE IT'S BEING UNFOLDED AND THEN DCBA HAS TO BE UNFOLDED AGAIN. AND THEN ALSO THERE'S A BIT OF SUCTION BECAUSE HAY GRABBED THE CAPSULE, SO THEY GET A PERFECT CUT. SO THEY DEVELOPED A PRECISION CATARACT SURGERY SYSTEM. WITH PHASE 2 THEY DID MICROENGINEERING BENCH TESTING IN VIVO SURGICAL WITH ANIMALS PERFORMANCE TESTING, THEN REGULATORY PATHWAY. NOW THIS IS THE SYSTEM THAT THEY ARE SELLING. FROM IRONICALLY THE WAY THINGS TURNED OUT, CATARACT SURGEONS WHEN THEY GOT WIND OF IT THEY LOVED IT SO MUCH THEY WANTED FOR ALL SURGERIES AND RIGHT NOW IT'S BEING SOLD FOR ADULT SURGERIES AND THEY ARE STILL WORKING ON THE PEDIATRIC PATHWAY. SO IF I REMEMBER I'LL COME BACK TO IT BECAUSE THERE'S ANOTHER MECHANISM THAT'S AVAILABLE NOW THAT WASN'T AVAILABLE THEN. THEY ACTUALLY GOT ON TO IT BEFORE IT WENT AWAY AND CAME BACK AGAIN. WE ARE ALSO INTERESTED IN INNOVATION. SO CATARACT SURGERY SEEMED STRAIGHT FORWARD SO COMMON PLACE, IS THERE AN ALTERNATIVE. WE KNOW THAT WHAT CATARACTS ARE, LENS CRYSTAL PROTEINS STATES BECOMING A GRATES AND INSOLUBLE AND BLACK LIGHT PASSING THROUGH. IT'S BEEN ESTIMATED THAT WE CAN DELAY CATARACT FORMATION BY TEN YEARS WE CAN REDUCE VISION CARE EXPENSES BY 50%, ALSO STOP THE PROGRESSION OR ACTUALLY REVERSE THEM. SO THERE'S TWO COMPANIES, FIRST ONE FEW POINT THERAPEUTICS. THAT'S BEEN SOME GOOD ACADEMIC RESEARCH SHOWING THAT YOU CAN REVERSE SOME OF THESE OR STOP THE PROCESS. IN VIVO. IN ANIMAL MODELS. SO THEY ARE DEVELOPING A TOPICAL TREATMENT FOR CATARACT, DESIGNING SYNTHESIZING SMALL MOLECULE CHAPERONES TO DESTABILIZE THAT AMYLOID AND RIGHT NOW THEY ARE IN THE PROCESS SCREENING SELECTING COMPOUNDS IN THE CATARACT MOUSE MODEL. SO GOING FORWARD WITH THAT, PLEX PHARMACEUTICALS, HERE WE GOT COMPETITION. THIS IS THE MARKETPLACE SO MALL MOLECULE ACTIVATORS, DRUG COMING AT IT WITH DIFFERENT MOLECULES BUT THEY ARE TRYING TO ALSO HAVE SMALL MOLECULE ACTIVATORS OF -- WITH CHAPERONE ACTIVITY TO AGAIN TRY TO REDUCE AND STOP THE PROGRESSION MAYBE EVEN REVERSE IT. IT SEEMS CATARACT SURGERIES ARE QUITE COMMON PLACE IN AMERICA BUT IN UNDERDEVELOPED COUNTRIES IT'S ACCESS TO THAT SORT OF SURGERY IS NOT UNIFORM. OR AVAILABLE OFTEN. THE THIRD WORLD MAYBE A GOOD MARKET FOR THIS. NOW I WOULD LIKE TO TALK ABOUT HOW THE PROGRAM IS EVOLVED OVER THE YEARS. BASICALLY WHEN I STARTED WAS GIVE A GRANT AND HOPE FOR THE BEST. PHASE 1 PHASE 2 AND FAST TRACK WERE THE PRIMARY TOOLS WE HAD. FROM CERTAINLY I HAVE LEARNED OVER THE YEARS I THINK NIH AS A WHOLE COMMERCIALIZATION IS A PROCESS. GIVING YOU A LITTLE BIT INDICATION YOU ARE MOVING ALONG, STEP BY STEP MAYBE START SELLING OUTSIDE AMERICA THEN FDA APPROVE TRIALS COME IN, AND VERY MANY DIFFERENT WAYS OF DOING IT. THERE IS A VARIETY OF PASS THROUGH THE MARKETPLACE, IT IS A DEVICE OR A DRUG? IS IT A SERVICE OR A PRODUCT? YOUR PATHWAY MAYBE DIFFERENT HOW QUICK YOU CAN GET THERE. REGULATORY APPROVAL, THAT CAN BE CRITICAL. AND IT VARIES, FDA HAS ONE WAY OF DOING IT, EUROPEAN UNION HAS ANOTHER WAY OF DOING IT AND OTHER COUNTRIES MEXICO FOR EXAMPLE HAS THEIR OWN WAY OF DOING IT. I BRING IN MEXICO, I WILL MENTION THAT LATER. BUT THEY ARE ALSO THE BUSINESS CHALLENGES. THESE ARE STARTUP COMPANIES,, GREAT SCIENTISTS WHO STARTED THESE, BUT THERE'S THE BUSINESS SIDE. THERE'S THE BUSINESS OF SCIENCE, NOT JUST THE SCIENCE OF SCIENCE. REIMBURSEMENT. YOU MAKE A PRODUCT BUT WHO IS GOING TO PAY FOR IT. IS IT THE PATIENT. IS IT THE CLINICIAN. IS IT THE HEALTH INSURANCE COMPANY, IS IT CMS, MEDICARE, OR COMBINATION OF ALL THREE? IF IT'S TELEMEDICINE IS ANYBODY GOING TO PAY FOR IT? LET ME GO BACK. SO NOW IT'S 2020, WE HAVE PHASE 1, PHASE 2 FAST TRACKS AND WE HAVE THE PHASE 2 COMPETING RENEWAL. MANY TIMES VERY COMPLEX PROJECTS. MILLION DOLLARS DOESN'T GO AS FAR AS IT USED TO SO A SECOND GRANT CAN HELP YOU GET THROUGH, IF YOU NEED FEDERAL REGULATORY APPROVAL OR COMPLEX ENGINEER ORGANIZE BOTH. DIRECT TO PHASE 2. OVER THE YEARS COMPANIES COME TO ME AND SAID I HAVE FEASIBILITY PROOF OF CONCEPT DONE, WHY NEED PHASE 1? I HAVE TO SAY IT'S THE LAW. NOW CONGRESS IN RE-AUTHORIZATIONS HAS GIVEN US THE DIRECT TO PHASE 2 SO YOU HAVE THAT PROOF OF CONCEPT IN HAND YOU CAN GO TO PHASE 2. NOW WE HAVE THE COMMERCIALIZATION READINESS PILOT PROGRAM. THERE ARE DETAILS I HAVEN'T TOLD YOU ABOUT BUT ONE DETAIL IS WE DON'T FUND VIRTUAL COMPANIES. FOR PHASE 2 GRANT MINIMUM OF 50% WORK NEEDS TO BE DONE BY SMALL BUSINESS. BUT IF YOU GET TO THE POINT YOU ARE READY TO START CLINICAL TRIAL YOU NEED GOOD MANUFACTURING PRACTICES, GOOD CLINICAL PRACTICE, SAFETY TOXICOLOGY, THAT SORT OF WORK MOST SMALL BUSINESSES DON'T HAVE THE EXPERTISE OR FACILITIES TO DO WHAT THEY NEED TO DO, THEY NEED CONTRACT RESEARCH ORGANIZATION. ONE BIG THING ABOUT CRP YOU CAN SUBCONTRACT OUT ALMOST ALL THE WORK. GET THAT EXPERTISE. ALLOWS YOU TO DO OTHER THINGS THAT REGULAR SBIR GRANTS WON'T ALLOW YOU TO, MARKET RESEARCH FOR EXAMPLE, PATENT WORK. AND THAT REMINDS ME MENOSIS, GO BACK TO THE ZEPTO CATARACT. THE LAST STEP WAS A 1 CRP, THEY USE THAT TO GET THEMSELVES READY FOR CLINICAL TRIALS AND THEY DID THE CLINICAL TRIALS THAT GET THEM THE FDA APPROVAL IN AMERICA AND AROUND THE WORLD. THEY HAVE CE MARK 2. OKAY. SO ANOTHER EXAMPLE OF CRP, OWEN THERAPEUTICS. THEY GOT THEIR PHASE 1 GRANT IN 2012 DEVELOPING A SMALL PEPTIDE FAST MEDIATED RETINOL CELL DEATH. THIS INHIBITS THAT. THE FIRST TARGET RETINAL DETACHMENT, RETINAL DETACHMENT OF COURSE YOU ARE NOT GETTING THAT IN CLINIC. YOU GET SYMPTOMS CALL THE EYE DOCTOR, I CAN'T SEE THIS, WE HAVE TO GET YOU IN AND GET REATTACHMENT SURGERY DONE. THERE'S GOING TO BE A TIME GAP. SO THE IDEA HERE IS PROVIDE A DRUG THAT WILL DELAY THAT CELL DEATH UNTIL SURGICAL REATTACHMENT CAN HAPPEN. 2014 PHASE 2 GRANT IND ENABLING. INVESTIGATIONAL NEW DRUG APPLICATION. I HAVE TALKED ABOUT THIS, NOW GIVING IT A NAME. THOSE PHARMACOLOGY AND SAFETY TESTS THAT YOU NEED TO DO ON A DRUG. DOSING. MAXIMUM TOLERATED DOSE. THERE'S A LIST OF THINGS THAT NEED TO BE DONE. IND ENABLE BEFORE WE GO TO FDA I LIKE TO GET APPROVAL TO DO A CLINICAL TRIAL IN AMERICA. SO THEY WANTED COMMERCIALIZATION READINESS PROGRAM IN 2017 DID SOME MORE WORK AND NOW THEY ARE IN INITIAL PHASE 1 SAFETY TRIALS FOR TREATMENT OF RETINAL DETACHMENT. SO IT'S NOT A COMMERCIAL SUCCESS YET IN ONE SENSE NO SALES BUT THEY HAVE TAKEN A BIG STEP AND THEY HAVE GOT BIG PHARMACEUTICAL COMPANY VERY INTERESTED TO THE POINT THEY MADE AN INVESTMENT AND THEY GOT ONE OF THEIR PEOPLE ON THE BOARD. AND THEN MORE EVOLUTION. TECHNICAL AND BUSINESS ASSISTANTS, I HAVE ALLUDED TO THE BUSINESS OF SCIENCE. WE NOW HAVE AVAILABLE PROGRAMS AND RESOURCES TO ASSIST GRANTEES IN TECHNICAL DECISIONS. THERE ARE LOTS OF TECHNICAL DECISIONS YOU NEED TO MAKE BEFORE YOU GO TO THE FDA. THERE WAS ONE COMPANY WE HAD FUNDED, THEY DID THEIR WORK WITH A TAGGED PROTEIN GFP, ATTACHED TO THE MOLECULES, ADS THEY DID THEIR EXPERIMENT. HERE IS ALL THE DATA WE HAVE GOT, FDA SAYS WHAT ABOUT THE FLUORESCENT TAG? THAT'S PART OF THE PRODUCT. NO. WE'LL GO BACK AND DO IT ALL OVER AGAIN. AND COME BACK WHEN YOU HAVE THAT CLEAN DATA. THAT'S WHY I SAID EARLIER YOU ALWAYS THINK COMMERCIALIZATION. MINIMIZING TECHNICAL RISKS AND A KEY THING COMMERCIALIZATION OF NEW PRODUCTS AND PROCESSES. ALL THESE THINGS COST MONEY. YOU TALK DIFFERENTLY TO TO SCIENTISTS AND TO REGULATORY- AGENCIES. IN THE EARLY DAYS MARKET RESEARCH TO COMPANIES, PHASE 1 COMMERCIALIZATION ASSISTANCE PROGRAM. THAT GAVE SOME ASSISTANCE TO TEACHING PEOPLE HOW TO DO THE BUSINESS IF THEY DIDN'T KNOW THOUSAND DO THAT. IN ADDITION WE HAVE GOT -- THIS IS FOR PHASE 1 GRANTEES, I CORE INTENSIVE AND ENTREPRENEURIAL EMERGENT FORCE, BASICALLY WHAT THIS SAYS THE MANTRA IS GET OUT OF THE LAB, GO FIND YOUR CUSTOMERS, ASK NEM WHAT THEY WANT. ASK THEM WHAT THEY WANT. WHO ARE THE CUSTOMERS. ONE OF THE BED MARKS FOR THIS PROGRAM, THEY HAVE TO INTERVIEW 100 POTENTIAL CUSTOMERS. FOR A SCIENTIST TO GET OUT OF THE LAB AND GO TALK TO PEOPLE AND SAY WHAT WOULD YOU DO, WHAT WOULD IT TAKE FOR YOU THE BUY MY PRODUCT? IS THIS WHAT YOU REALLY NEED? IF YOU MAKE IT THEY WILL COME. WRONG. COMMERCIALIZATION ACCELERATOR PROGRAM, THAT'S COMMERCIALIZATION ASSISTANCE PROGRAM HON STEROIDS. NOW WE HAVE ADDED -- THERE'S THREE SEPARATE TRACKS, ONE IS BASIC, COMMERCIALIZATION, LEARN HOW TO TALK TO INVESTORS, IT'S YOUR PITCH YOUR ONE MINUTE ELEVATOR TALK. THE ADVANCE TRACK, THERE ARE COMPANIES SMALL BUSINESS, THEY HAVE THAT BUSINESS EXPERTISE. THEY ARE INNOVATIVE, GOT A NEW PRODUCT, A NEW FIELD, THEY DON'T KNOW THIS. THEY HAVE BEEN DOING DRUGS, NOW THEY GOT DRUG DELIVERY. THAT'S A NEW AREA. GOT TO TALK TO NEW PEOPLE, GOT PARTICULAR PROBLEM THEY NEED SOLVED. LASTLY, THE REGULATORY TRACK WHICH THAT GIVES THEM THE ASSISTANCE IN THEIR KNOW HOW TO TALK TO REGULATORY PATH WE ALSO HAVE AVAILABLE ENTREPRENEURS AND RESIDENTS, I MYSELF AM A TRAINED SCIENTIST MOST PROGRAM OFFICERS ARE TRAINED SCIENTISTS. I MAYBE UNUSUAL I WORKED FOR A BIOTECH COMPANY FOR EIGHT YEARS. WE HAVE NOW ENTREPRENEUR AT THE NIH, I WILL TALK ABOUT SEED OFFICE IN A MOMENT. THESE ARE PEOPLE WHO HAVE DONE THIS, THEY STARRED THEIR OWN COMPANIES, VENTURE CAPITALISTS, THEY KNOW HERE IS WHAT YOU NEED HOW TO GET TO THE MARKETPLACE. THAT IS THE RESOURCE AVAILABLE TO SMALL COMPANIES NIH WIDE AND THEN LASTLY INVESTOR MEETINGS. WE ALL GO TO ARBO. BUT THE INVESTORS ARE GOING TO MEETINGS TOO. THEY ARE TALKING AMONG THEMSELVES HOW BEST DO I PICK WINNERS THROUGH NIH WE ARE NOW GETTING ASSISTANCE TO GO TO FILE, ACA ANGEL, CAPITAL ASSOCIATION. ASSOCIATION OF ANGEL INVESTORS. ET CETERA, ET CETERA. STANLEY MORGAN HAVE THEIR MEETINGS. THEY ARE SCIENTISTS OUR COMPANIES NOW GET A CHANCE TO GET IN FRONT OF THESE PEOPLE AND SAY HERE IS WHAT WE WANT TO CREATE. HERE IS WHAT WE ARE CREATING. AND ANOTHER COMMERCIALIZATION IS A PROCESS, VISION QUEST BIOMEDICAL, THEY ARE CREATING THE EYE STAR, ONE OF THE DIABETIC ARTIFICIAL INTELLIGENCE ALGORITHM SYSTEMS FOR VISION SCREENING. SO IT'S A COMPUTER BASED SCREENING FOR DIABETIC RETINOPATHY. A PROBLEM FOR COMPLIANCE WITH ANNUAL VISION SCREENING. SO IS GOAL OF THIS COMPANY WAS TO DEVELOP RAPID AFFORDABLE SEMIAUTOMATED VISION SCREENING. IDEALLY THEY WILL -- AS I'LL MENTION IN A MOMENT BUT AN IMPORTANT THING IS EVALUATE LARGE NUMBER OF DIABETICS FOR VISION. BASICALLY GO IN GET PICTURE FUNDUD CAMERA, NON-DILATED IMAGING SO YOU DON'T HAVE TO DILATE THE PUPIL, THE IMAGE GOES UP TO THE CLOUD, THE EYE STAR ALGORITHM IS THERE, TWO MINUTES YOU GET THE RESULTS, THE PATIENT HASN'T LEFT THE CHAIR OR THE OFFICE AND BUT IT'S DOING AND THIS IS AN ALGORITHMMENT THAT'S NOT TRYING TO SAY YOU HAVE THIS DISEASE, IT'S REALLY DISSECTING OUT DISTINGUISHING YOUR NORMAL YOU ARE FINE, COME BACK IN A YEAR. YOU HAVE GOT A PROBLEM. YOU NEED TO SEE AN OPHTHALMOLOGIST RIGHT AWAY. SO FOR OPHTHALMOLOGISTS, THE WAY THE SYSTEM WORKS, THEY MAKE THEIR BEST PROCESS ON TREATING PATIENT WHOSE HAVE HEALTH PROBLEMS. 75% OF THE PATIENTS THAT HAVE GOOD EYES WILL NOT MAKE THAT BIG OF A MARGIN THERE SO THE 25% ARE ONES THE EYE CARE SPECIALIST WANTS TO SEE GETS STREAMLINES MAKE ITS IT MORE EFFICIENT. ET CETERA. ET CETERA. ARTIFICIAL INTELLIGENCE, IT'S A SMALL BUSINESS FAST TRACK, PHASE 1 FEASIBILITY THE AI ALGORITHM ON LARGE DATA SET, THIS IS RETROSPECTIVE. THEY ARE ABLE TO OPTIMIZE AND VALIDATE THE ALGORITHM SO THEY CAN DISTINGUISH ABNORMAL FROM NORMAL. THEN THEY WENT IN TO PHASE 2 AND THERE THEY IMPROVED THE AI ALGORITHMS BUT THEY ALSO GOT OTHER GRANTS, THEY WERE USING US. THEY USE US WISELY, BECAUSE AUTOMATIC IMAGE QUALITY ASSESSMENT IS KEY, THAT'S ONE OF THE STRONG SELLING POINTS, THEY HAVE SEVERAL COMPANIES INTERESTED IN PUTTING THAT INTO THEIR CAMERAS. REGARDLESS OF DIABETIC RETINOPATHY SCREENING. ON TO HAVE TOP OF THAT, THEY WANTED TO DEVELOP THEIR OWN HAND HELD LETNAL CAMERA. -- RETINAL CAMERA. THEY GOT PHASE 2B COMPETING RENEWAL, MORE WORK, IT'S A COMPLEX SYSTEM THEY ARE DEVELOPING, NOT ONLY ALGORITHM, IT'S GETTING INTO CLINICAL NETWORK SO THEY BEGAN CLINICAL STUDIES PROSPECTIVELY. AND THEN BUSINESS CHALLENGES THE REIMBURSEMENT. THIS IS A -- THE AFFORDABLE CARE ACT CAME INTO PLAY. BECAUSE THAT SET METRICS FOR SELF-INSURANCE COMPANIES, THEY ARE VERY INTERESED IN THEM AND THEY HAD DEALS BECAUSE NOW THEY HAD ALL OF THEIR PEOPLE, ALL OF THEIR PATIENTS,ES ALL OF THEIR CLIENTS SCREENING FOR VISION AND HOW TO DO THAT. THIS IS THE WAY TO DO IT. THEY ARE VERY INTERESTED. CLINICIAN ACCEPTANCE. WORK FLOW IS VERY RAPID IN CLINICAL SETTING. YOU HAVE TO SEE PEOPLE, SOME OF YOU KNOW THAT BETTER THAN I DO. OF COURSE THE FEDERAL REGULATORY REQUIREMENTS, THAT TOOK A GOOD DEAL OF WORK. ALWAYS A BACK AND FORTH NEGOTIATING WHAT'S THE BEST ASPECT OF THE CLINICAL TRIAL. THEY ARE COMMERCIALIZING IN MEXICO. MEXICO HAD THEIR OWN FDA THEY FOUND PEOPLE THAT THEY WORK WITH IT'S A LONG STORY, I HAVEN'T GOT TIME TO GO INTO IT BECAUSE I'M RUNNING OVER. NOW THEY ARE WORKING ON CE MARK AND SOON TO BEGIN FDA CLINICAL TRIAL. AARON HADN'T MENTIONED A COMPANY ALREADY HAD FDA APPROVAL. THAT'S AN EXAMPLE OF BUILD IT THEY WILL COME. IT'S ONE THING FOR FDA APPROVAL NOW YOU HAVE TO GET CLINICAL ACCEPTANCE. CPT CODE SOME OF YOU KNOW WHAT THAT IS, SOME OF YOU MAY NOT. THAT'S HOW THE HEALTH INSURANCE COMPANY PAYS FOR THINGS. IF THERE IS NOT CODE FOR THAT NOBODY WILL PAY. THAT IS KEY THING. I'LL FINISH UP QUICK LOOKING TO THE FUTURE. I THINK THINGS HAVE BEEN GOING VERY WELL BUT MONITORING COMMERCIALIZATION PROGRESS, THAT IS TRICKY THING, ALL OF NIH IS WORKING ON THAT. DEVELOPING A COMPANY TRACKING DATABASE. BECAUSE COMMERCIALIZATION HAPPENS AS A PROCESS IN STEPS AND LONG AFTER THE LAST GRANT. WHEN WE ARE WORKING NOW WITH NEI PROGRAM ANALYSTS TO TRY TO PULL TOGETHER THIS DATA. IT'S QUITE A BIT OF DATA NOT ALL IN IMPACT TWO DATABASE WE HAVE AT NIH. KEY STEP IS FUNDING DECISIONS WE HAVE STRONG APPLICATIONS TRYING TO MAKE BETTER STRATEGIC FUNDING DECISIONS, WORKING WITH OTHER ICs LEARNING FROM THE OTHER SMALL BUSINESS PROGRAM OFFICERS AND VICE VERSA. ONE THING I WOULD LIKE TO DO IS ENHANCE THE SMALL BUSINESS WEB PAGE. SMALL BUSINESS EDUCATION ENTREPRENEURIAL DEVELOPMENT, THAT IS OFFICE OF DIRECTOR OF NIH. EACH NIH INSTITUTE MANAGES THEIR OWN SMALL BUSINESS. SO THIS OFFICE, THEIR JOB IS LIKE HERDING CATS. BUT EACH INSTITUTE HAS A DIFFERENT COMMUNITY, DIFFERENT WAYS OF DOING THING. DIFFERENT SIZES. SO THEY OVERSEE THE GENERAL PROGRAM BUT THEY ARE NOW PROVIDING US WITH SMALL BUSINESS OPPORTUNITIES, AND RESOURCES THAT'S WHERE THE ENTREPRENEUR RESIDENCE ARE LOCATED. THEY GIVE OUTREACH ANGEL INVESTORS VENTURE CAPITALISTS, ET CETERA, ET CETERA,. SO THEY ARE DOING MORE NOW EVOLVING HOW WE COULD HAVE MOVE COMPANIES FROM THAT FIRST PHASE 1 FEASIBILITY PROOF OF CONCEPT UP TO COMMERCIALIZATION GETTING THESE INNOVATIVE STRONG THINGS OUT TO PEOPLE. AND HELP PATIENTS OF ALL AGES. SO AN ENTREPRENEURIAL TRAINING. THANK YOU FOR YOUR ATTENTION. SORRY IF I RAN LONG. ANY QUESTIONS? >> VERY IMPRESSIVE. THANK YOU FOR THAT PRESENTATION. SEEMS LIKE NEE AND OUR RESERVING IS THE PERFECT FODDER FOR SBIRs AND IN TURN YOU FOR THEM. FOR THE DEVELOPERS, HOW DOES NEI DO WITH THEIR SBIR SUCCESSES COMPARED TO OTHER INSTITUTES? >> WE ARE IN THE SAME BALLPARK AS EVERYBODY ELSE. SUCCESS RATES FOR GRANT APPLICATION, THAT'S VARIABLE BECAUSE YOU GOT THE SMALL PHASE 1 AND LARGE PHASE 2s. >> I MEANT NOT -- >> COMMERCIAL SUCCESS. >> YES. >> THAT'S ONE OF THE PROBLEMS WE ARE STRUGGLE WITH, HOW QUANTITATED, WHAT EXACTLY IS COMMERCIAL SUCCESS FOLLOWING THEM ALL. EVEN RECENTLY I'M GOING THROUGH THINGS,OH MY GOD, TRACKING THEM AND KEEPING AN EYE ON THEM, THAT'S WHY IT'S IMPORTANT TO HELP GOOD RELATIONSHIPS. NOBODY KNOWS HOW GOOD WE ARE DOING. I WILL SAY ACADEMY OF SCIENCES ELECTRICAL ENGINEERING OF MEDICINE, THEY HAVE BEEN DONE SEVERAL REPORTS OVER THE LAST 20 YEARS, THE NIH SBIR PROGRAM, BOTTOM LINE, THEY SAY WE ARE DOING WELL, EVERYTHING CAN BE IMPROVED BUT IT'S FUNCTIONING WELL. >> THANK YOU FOR THAT. SO DO -- IN ORDER TO GO FOR SB,R DO YOU RECOMMEND THERE'S IP ALREADY OBTAIN IN >> DEFINITELY. TO GET SOMETHING COMMERCIALIZED YOU NEED THAT IP PROTECTION. VENTURE CAPITAL WON'T TOUCH IT IF IT'S NOT THERE. EVEN REVIEWERS THOUGH IT'S NOT IN THE REGULATIONS ROVERS KNOW THAT HAS TO BE THERE, YOU NEED A PLAN IF YOU HAVEN'T GOT IT IN PLACE. >> THANK YOU, JERRY. I JUST WANTED TO MAKE SURE WE HAD LEFT SOME TIME FOR GENERAL COUNCIL DISCUSSION. SO WE CAN START THAT NOW, IF THERE ARE ISSUES OR CONCERNS, THAT YOU ALL HAVE, THAT YOU WANT TO MAKE US AWARE OF. >> ANYTHING YOU HEARD ABOUT THIS MORNING THAT YOU WOULD LIKE CLARIFICATION ON OR MORE INFORMATION ON WE CAN ENTERTAIN THAT NOW OR DURING LUNCH. IS THERE AN ESTIMATED TIME FRAME FOR WHICH THIS STUDY SECTION CHANGES WILL TAKE PLACE? HOW LONG DO WE HAVE BEFORE CHANGE? IS GOING TO BE FORCED UPON US. >> WE HAVEN'T HEARD ANY OF THAT YET. >> SO FOR OUR COMMUNITIES, THINGS ARE STABLE FOR THE NEXT SUBMISSION ROUND, NEXT TWO, PROBABLY? >> I CAN'T IMAGINE THEY WILL MAKE CHANGES WITHOUT GIVING SOME LEAD TIME ON IT. BUT WE DON'T HAVE ANY INFORMATION ABOUT IT. IT SEEMED CLEAR FROM HIS PRESENTATION TODAY THAT THE DECISION HAS ALREADY BEEN MADE AND THEY PLAN TO STICK WITH IT. REGARDLESS OF OUR OBJECTIONS. WE DON'T HAVE A TIME FRAME YET. THANK YOU. >> I WAS LOOKING THROUGH -- TALKING TO COLLEAGUES AND ONE CONCERN IS THAT THERE IS NO MECHANISM FOR NEW RESEARCHERS IN THE FIELD WHO GET TRAINED. THERE WAS A REALLY GREAT COURSE IN YEARS AGO THAT HAS DISAPPEARED FUNDED BY NEI I THINK. THAT WAS A QUERY, IF THAT WOULD BE SOMETHING THAT WOULD BE WILLING TO LOOK AT. >> THAT IS A NOTE I MADE DURING THE PRESENTATION. SEEMS LIKE TRAINING IS NEEDED THERE. >> ALONG THAT -- MAYBE FUNDING MECHANISMS MORE RO 3 WERE REALLY YOUNG -- ASSISTANT PROFESSORS >> THERE ARE SPECIFIC TRAINING MECHANISMS, WE HAVE DONE THESE IN THE PAST USING THE R 13 WHICH IS REALLY A CONFERENCE GRANT MECHANISM, THERE IS A MECHANISM SPECIFIC MECHANISM FOR TRAINING DEVELOPING TRAINING PROGRAMS, THEY ARE MOST COSTLY TO US BECAUSE WE HAVE TO PAY INDIRECT COSTS ON THEM AND WE DON'T -- R 13s BUT WILL CERTAINLY LOOK AT THAT, THIS IS A VERY OBVIOUS NEED. WE MAY SEE SOME OF THIS COMING OUT OF THE BRAIN INITIATIVE. BECAUSE THIS IS CERTAINLY A HIGH EMPHASIS RIGHT NOW. WE MAYBE ABLE PARTNER WITH THEM. >> I DON'T KNOW HOW MUCH BUDGE F 32 AND 33 NEI. >> WHAT THE ACTUAL BUDGET? >> YEAH. IS THERE A GOOD -- >> I DON'T HAVE THAT NUMBER OFF THE TOP OF MY HEAD. BUT IT IS INCREASED EVERY YEAR BOTH FOR F AND K PARTLY BECAUSE STIPENDS HAVE GONE UP AS WELL YOU HAVE TO LIE TO THEM. OUR GOAL IS TO NOTE LET THE NUMBER OF SOLUTION DECLINE AND TRY TO KEEP INCREASING THEM. THE ONE SHIFT WE HAVE BEEN MAKING IS MOVING AWAY FROM THE INSTITUTIONAL GRANTS, K 12s FOR THE Ks AND THE SAME WITH TO THE INDIVIDUAL GRANTS. THIS IS THE RESULT OF SEVERAL STUDIES NOW COMING OUT OF THE NATIONAL ACADEMIES THAT SHOW IF YOU ARE ON AN INDIVIDUAL TRAINING GRANT YOUR SUCCESS RATE GETTING EVENTUALLY GETTING YOUR OWN RO1 IS MUCH HIGHER, IN FACT WE LOOK AT OUR OWN DATA. IT'S DOUBLE THE SUCCESS RATE IF YOU HAD AN INDIVIDUAL GRANT. DISTRIBUTION OF OUR FUNDS WAS VERY LOPSIDED TOWARDS INSTITUTIONAL FUNDING VERSUS INDIVIDUALS. SO WE DON'T WANT -- WE UNDERSTAND INSTITUTIONS NEED TO HAVE THE INSTITUTIONAL GRANTS TO CAPTURE THAT DESIRABLE CANDIDATE WHO WALKS IN THE FRONT DOOR AND WE DON'T WANT TO PULL THE RUG OUT OF PEOPLE WHO ARE DEPENDING ON THAT BUT WE WANT TO GRADUALLY MIGRATE TO LESS MONEYED INSTITUTIONAL GRANTS AND MORE FOR INDIVIDUAL FELLOWSHIPS. BUT OUR SUCCESS RATE IS VERY GOOD. >> THEY ARE NOT IN OUR -- >> WE DON'T PARTICIPATE IN THE RO 3 MECHANISM. >> IS THERE ANY INTEREST TO HAVE THAT MECHANISM? R21st ARE SEEN MORE HIGH RISK HIGH IMPACT AND MANY BEINGER ASSISTANT PROFESSORS MIGHT NOT BE COMPETITIVE FOR THAT. >> THE PROBLEM WITH THE RO 3s IS THAT IT'S A VERY SMALL AMOUNT OF MONEY AND IT'S NOT A RENEWABLE. THE COST OF ADMINISTRATING A VERY TINY AWARD LIKE THAT, IS VERY HIGH. SO WE MOVED AWAY FROM THE RO 3 MECHANISM TEN YEARS AGO. >> I'M JUST SAYINGS THAT THE FIRST ONE I GOT AND REALLY GOT ME GOING. I THINK THAT'S PROBABLY EXCEPTIONAL BECAUSE IT DOESN'T REALLY GIVE A YOUNG RESEARCHER ADEQUATE TIME AND RESOURCES TO DO A GOOD JOB SO WE TRY TO PUSH PEOPLE INTO PUTTING IN THEIR RO1. THERE'S ADVANTAGES AND HOW IT'S REDEEMED AT CSR. THEY REVIEW TOGETHER. SO THEY DON'T COMPETE WITH THE OTHER MORE EXPERIENCED RO 1 PIs. SO WE WOULD RATHER SEE THEM PUT IN AN RO1. >> I SHOW THE THE DATA LAST TIME THE SUCCESS RATE FOR EARLY STAGE INVESTIGATORS COMPETING FOR RO1s IS EXCEPTIONAL AT IN MEI. SO WE REALLY PUSH THEM TO USE THAT MECHANISM AND NOT OTHER MECHANISMS BECAUSE WE GIVE THEM FIVE YEARS OF FUNDING AND THAT IS TIME FOR THEM TO PUBLISH THOSE RESULTS AND COME IN WITH A COMPETING RENEWAL AND HAVE A GOOD CHANCE OF HAVING A SUCCESS RATHER THAN STARTING ALL OVER AGAIN. SO WE HAVE A REALLY STRONG DEDICATION TO THAT AND REALLY ENCOURAGE PEOPLE TO USIA IT. >> CATHY YOU MENTIONED TRAINING, I WAS CO-DIRECTOR WITH TED OF THE FUNDAMENTAL ISSUES AND VISUAL RESEARCH ON COURSE THAT RAN FOR A NUMBER OF YEARS. IT GOT SNAGGED UP IN A CHANGE IN LEADERSHIP WHERE THEY WENT FROM BEING OWNING THEIR OWN PROGRAMS TO BEING PART OF THE UNIVERSITY OF CHICAGO I BELIEVE. SINCE THE TIME WE STOPPED RUNNING THE PROGRAM I HAVE BEEN TRYING TO REBOOT IT ALONG WITH SIMON JOHNS. WE HAVEN'T REALLY TALKING ABOUT WHETHER WE COULD START AT JACKSON LABS OR WOODSILL OR SOMEWHERE ELSE. WE ARE TALKING ABOUT IT AND WE NEED TO HAVE A STRONG GROUP OF BOTH INTERIOR AND POSTERIOR SEGMENT PEOPLE TO PUT IT TOGETHER BUT IT WAS A WONDERFUL OPPORTUNITY AND TRAINED A LOT OF YOUNG PEOPLE AND GAVE THEM A GREAT OPPORTUNITY TO SPEND TIME LEARNING TECHNIQUES AND IMAGING PROCEDURES AND MEET ONE ANOTHER AND IT WAS A LOT OF FUN. SO I HOPE YOU CAN GET IT GOING AGAIN. WE WILL SEE. >> WE FUNDED THAT IN THE PAST ON A U 13 MECHANISM WHICH IS JUST THE SAME CONFERENCE GRANT MECHANISM, ONLY TO USE A COOPERATIVE AGREEMENT SO WE CAN HAVE INVOLVEMENT IN THE COURSE AND SPEAKERS. >> I ALSO WANT TO MENTION THERE IS GOING TO BE A NEW EARLY STAGE INVESTIGATOR AWARD CALLED THE STEVE CATS AWARD. THIS AWARD IS GOING TO BE USING AN RO1 MECHANISM FOR AT RISK EARLY STAGE INVESTIGATORS WHO WISH TO CHANGE FIELDS. SO IF THEIR WORK IS HIGHLY INNOVATIVE, THEY WERE NOT TRAINED IN THAT WORK, THEY ARE NOT REQUIRED TO SHOW ANY PRELIMINARY DATA AND IT GIVES THEM AN OPPORTUNITY TO LAUNCH THEMSELVES IN A NEW DIRECTION. WITHOUT PENALTY. KEEP YOUR EYES OPEN, IT'S STILL IN DEVELOPMENT AND WE ARE WORKING THROUGH SNACKS BUT IT WAS ANNOUNCED AT THE ACD MEETING. >> IS THAT NIH WIDE? >> YES. ONLY FOR NEW INVESTIGATORS NOT CAREER THINKING. >> IT'S CALLED -- EARLY STAGE INVESTIGATORS. >> I HAVE A QUESTION FOR MIKE CAN ANSWER THIS MAYBE, GLOBAL QUESTION. DO WE HAVE ANY DATA ON THE NUMBERS OF INVESTIGATORS SAY PER YEAR APPLYING IN -- LET'S DIVIDE UP NEI TO THREE SEGMENTS. VISUAL PATHWAYS PERCEPTION SYSTEMS NEUROSCIENCE, BASIC BIOLOGY OF THE RETINA AND VISUAL PATHWAYS AND DISEASE. BOTH APPROXIMATE TIER SEGMENT. GOOD DATA ON NUMBERS OF GRANTS COMING IN AND AGE DISTRIBUTION OF THE INVESTIGATOR. PROBABLY AI QUESTION. >> THAT'S NOT SOMETHING WE TRACK, WE MOW EXACTLY THE BREAKDOWN IF WE WANT TO LOOK AT RETINA VERSUS CORNEA VERSUS CENTRAL PATHWAYS. THOSE NUMBERS ARE VERY CLEAR AND AVAILABLE DIVING DOWN WITHIN THOSE EACH OF OUR CATEGORIES HAS SUBPROGRAM AREAS AND THEY ARE CATEGORIZED THAT WAY AND WE CAN POOL THAT DATA AS FOR THE AGE OF THE INVESTIGATOR, THAT'S NOT SOMETHING AVAILABLE TO US IMPACT WE COULDN'T TELL YOU THAT. >> IT'S QUESTION THAT PERTAINS TO REORGANIZATION STUDY SECTIONS TOO. I DON'T KNOW CSR >> SOMEBODY KEEPS TRACK OF THAT INFORMATION BECAUSE NOW AND AGAIN THERE'S THERE'S A SCIENCE ARTICLE ABOUT AGING OF THE RO1 COHORT. I DON'T KNOW WHERE THAT INFORMATION IS HOUSED WHETHER'S BROKEN DOWN BY IC. SOME INFORMATION IN THE APPLICATION IS VOLUNTARY, FOR EXAMPLE, MINORITY STATUS AND SEX AND THIS IS VOLUNTARY INFORMATION. IT'S NOT A MADE AVAILABLE TO THE ICs, THE NIH OD DOES HAVE THAT INFORMATION. IF YOU HAVE THE SPECIFIC REQUEST AND SPECIFIC NEED YOU CAN GO TO THEM AND THEY WILL DO THE ANALYSIS FOR YOU AND PROVIDE YOU WITH THE DATA. THAT'S WHY YOU SOMETIMES SEE THESE THINGS. WE DON'T HAVE OUR OWN ACCESS TO IT. HAS THE PLANNED CHANGE IN THE STUDY SECTION BEEN ANNOUNCED TO ALL THE VARIOUS SOCIETIES THAT WILL BE AFFECTED BY IT? >> NO. THE PROCESS HAS BEEN COMPLETELY UNDER WRAPS. THIS IS THE FIRST PUBLIC DISCUSSION OF IT THAT I'M AWARE OF. >> I KNOW I'M NAIVE, IN MY OPINION NOTHING IS OVER UNTIL IT'S OVER. WE DO LIVE IN THE UNITED STATES. THIS IS A POLITICAL ORGANIZATION. CSR IS ACCOUNTABLE TO SOMEBODY. SO DON'T YOU THINK IN THE INTEREST OF DUE PROCESS, THE RELEVANT SUBSPECIALTY SOCIETIES ARE TO BE INVOLVED IN TWO LEVELS. ONE GETTING AN OPPORTUNITY TO COMMENT ON THE PROPOSED CHANGE, WITH A REQUIREMENT THERE BE RESPONSE TO THAT COMMENT. AND SECOND, WHEN WE THINK ABOUT WHAT IN MY ESTIMATION IS GROSSLY UNDERSTOOD ESTIMATED COMPLEXITY COMPLEXITY,, OF CONSTITUTING APPROPRIATE STUDY SECTION UNDER THIS PROPOSAL, I THINK SOCIETIES OUGHT TO HAVE AN ACTIVE ROLE IN CONTRIBUTING TO THE PROCESS OF IDENTIFYING THE MEMBERSHIP OF THE STUDY SECTION. >> WE CAN THINK HOW TO DO IT. LET ME TELL YOU WHAT MY MAIN CONCERNS ABOUT THIS. FIRST OF ALL IS ONE YOU IDENTIFIED EARLY ON IN DISCUSSION, IN THE PANEL MEMBERS NAMED UP THERE, ONLY ONE OF THOSE MEMBERS SERVED AS A REGULAR MEMBER ON ANY OF THOSE STUDY SECTIONS IN THE LAST TWO DECADES. THE OTHER THREE IDENTIFIED AS RESEARCHERS HAD AD HOC SERVICE ON MAYBE ONE MEETING WHERE THEY MAY HAVE CALLED IN TO REVIEW ONE GRANT, ONE PERSON AS A DROSOPHILA RESEARCHER WHO REVIEWED TO OR THREE TIMES OVER THE PERIOD THAT WAS UNDER STUDY. WE DIDN'T FEEL THERE WAS ADEQUATE EXPERTISE. THAT EXTERNAL PANEL. SECONDLY, ANN SCHAFFNER WENT TO THAT CSR COUNCIL MEETING WHERE THE INFORMATION WAS PRESENTED TO THE COUNCIL AND I DON'T WANT TO SPEAK FOR HER BUT I CAN SUMMARIZE COMMENTS TO FEEL THE ALTERNATIVE POSITION WAS NOT FAIRLY PRESENTED TO THE CSR COUNCIL ABOUT OUR CONCERNS H. WE ALSO FEEL THAT THE TWIN STUDY SECTION IS DEMONSTRATED FAILURE. THERE USED TO BE SEVERAL OF THESE FEW YEARS AGO AT CSR AND THEY HAVE GRADUALLY DISAPPEARED, HE COULDN'T ANSWER THE QUESTION, HOW MANY THERE ARE AND I BELIEVE THERE ARE NOW TWO PAIRS OF TWINS LEFT. ONE OF THEM MY UNDERSTANDING ONLY MEETS AS A TWIN WHEN A NUMBER OF APPLICATIONS IS REAL HIGH AND I THINK THAT'S AN ACTUALLY AN SBIR STUDY SECTION, NOT A REGULAR RPG STUDY SECTION. SO THOSE ARE SERIOUS CONCERNS. THEN THE ISSUE OF -- ABOUT TAKING THIS GROUP OF SCIENCE AND SPLITTING IT UP AND PUTTING IT AS MINORITY MEMBERS OF OTHER STUDY SECTIONS, IS A PROVEN FAILURE ALSO, THE STUDY THAT LED TO THE CREATION OF THIS STEP WAS TRIGGERED BY OUR ANALYSIS OF THE DATA THAT SHOWED THE CORNEA, ALL THE ANTERIOR EYE APPLICATIONS WERE BEING DIVIDED BETWEEN TWO STUDY SECTIONS WHERE THEY WERE 15% OF THE GRANTS IN THAT STUDY SECTION, ONE STUDY SECTION WAS TREATING THEM FAIRLY WELL AND THE OTHER SECTIO WAS NOT SO THERE WAS A CLEAR DISPARITY IN THE SCORES WITHIN THAT GROUP COMING OUT OF THE TWO STUDY SECTIONS. I BROUGHT THE DATA TO THEM, BRUCE WAS THERE AND LOOKED AT THE DATA SO THAT TRIGGERED THE EXTERNAL PANEL THAT MET AND PUT THIS TOGETHER. OF COURSE NOW WE ARE GOING BACK TO THAT SITUATION THAT WE THOUGHT HAD BEEN RESOLVED. THEY ARE FULLY AWARE OF THIS -- I CAN'T TELL YOU EMPHATIC I WAS ON THAT INTERNAL PANEL. THE OTHER MEMBERS OF THE INTERNAL PANEL WERE IN 100% AGREEMENT THOUGH NONE OF THEM WILL HAVE GRANTS THAT WILL BE REVIEWED IN STUDY SECTIONS BUT THEY UNDERSTOOD THE ISSUE. YOU SEE WHERE WE STAND. >> NEEDS TO BE POLITICAL PRESSURE BROUGHT ON THIS PROCESS, THAT'S WHAT HAS TO HAPPEN. YOU HAVE TO GO OUTSIDE THE SYSTEM TO DO THIS. THAT MEANS THERE HAS TO BE A SENATOR OR CONGRESSMAN WHO KNOWS ABOUT BLINDNESS RESEARCH, WE KNOW WHO THEY R THEY HAVE TO WRITE A LETTER AND ASK FOR EXPLANATION WHY THIS DECISION IS GOING AGAINST THE RECOMMENDATION OF A PROPERLY CONSTITUTED PANEL. IT'S IGNORING BY CONDITION. THE 2020 THING IS TOTAL LACK OF DUE PROCESS. THAT IS NOT OKAY. THAT'S NOT HOW WE OPERATE AS A COUNTRY. T SO WE SHOULD NOT JUST LET THIS HAPPEN. >> I AGREE. LET'S PUT OUR HEADS TOGETHER AND FIGURE THE BEST WAY TO DO THIS. MY SENSE IS THAT PUSH OUGHT TO COME FROM COUNCIL. >> AS FEDERAL EMPLOYEES WE CANNOT DO THAT. THE PUSH HAS TO COME FROM OUR STAKEHOLDER COMMUNITIES. >> BUT WE TRIED WITH THAT LETTER. >> LARGER STAKEHOLDER COMMUNITY. SUCH AS MARGO SUGGESTED. WE CAN CONTINUE THAT PART OF THE DISCUSSION. >> WE ARE ALL GOING TO GO TO ARBO AND GO TO BUSINESS MEETINGS. WE NEED TO TALK IF YOU ARE NOT ON THE SCHEDULE FOR YOUR BUSINESS MEETING IF SOMEONE FROM COUNCIL IS NOT ON THE -- AS NOT ASKED TO SPEAK AT YOUR BUSINESS MEETING AND ARVO ABOUT THIS TOPIC REQUEST PERMISSION TO SPEAK. I HAVE. I WILL BE TELLING PEOPLE THAT THEY SHOULD OBJECT AND THESE LETTERS CAN BE WRITTEN BY AGGREGATE -- YOU ARE RIGHT. WE ARTICULATED POLITICAL PRESSURE NEEDS TO BE PUT TO BARE FROM ARGO TO NEI. I AGREE WITH -- (OVERLAPPING SPEAKERS) Q. AT NIH AS WELL, THIS IS ONLY AT THE LEVEL OF CSR. WE COULD ALSO GO TO MIKE LAUER DIRECTOR OF EXTRAMURAL RESEARCH ALL THE WAY TO FRANCIS COLLINS. >> WE SHOULD TWO TO -- DR. COLLINS SAYS WE SHOULD GO. THAT'S -- >> DID HE GET COPIED ON THE LETTER? NO. >> WE SHOULD DO THAT, WE SHOULD DO THAT TODAY. >> ALONG WITH SOME NOTE THAT SAYS CSR TOLD US THE DECISION HAS BEEN MADE. WITHOUT DUE CONSIDERATION. >> THAT'S WHY WE ARE COPYING HIM NOW. >> BE ORGANIZED. >> YOU MAY BE LISTENING NOW. >> WIRELESS PHONE HEADSET BATTERY, I JUST GOT THIS, MAIL. HE'S COMING IN ZOOM. SO YOU COULD ASK THEM THIS AFTERNOON. HE'S GOING TO ZOOM IN. FROM >> ANY OTHER TOPICS BEFORE WE BREAK FOR LUNCH AND CLOSE THE OPEN SESSION? >> CAN I JUST ANOTHER TOPIC THAT WAS BROUGHT UP AS PARTNERSHIP WITH OTHER INSTITUTES LIKE NATIONAL INSTITUTE ON AGING, SPECIFICALLY TO BE ABLE TO GET TISSUES THAT APPARENTLY THEY ARE NOT EASILY ACCESSIBLE IF YOU ARE NOT FUNDED BY THE NIA, THAT'S ONE OF THE THINGS I HEARD. >> SO WE HAVEN'T HEARD A PROBLEM OF PEOPLE NOT BEING ABLE TO GIVE TISSUES, WE SUPPORT A GRANTS OF PEOPLE WHO CAN BUY EYE TISSUE FROM THEM. ONE ISSUE PEOPLE ARE TALKING ABOUT IS FRESHNESS OF TISSUE AND WE CAN WORK WITH THEM.ITICAL.- THEY ARE OPEN TO US. TO THEM UNTILING THEM WHAT OUR SPECIFIC NEEDS ARE AND BEING ABLE TO SUPPLY IT. ACTORRBO HAS A BIG INITIATIVE NOW TO WORK WITH iBANKS TO GET TISSUE AVAILABLE. WE CAN PARTNER WITH THEM AS WELL. >> ALONG WITH THAT FOR FUTURE FUNDING OPPORTUNITIES AS DISEASES THAT ARE ALSO AFFECTING THE H DISEASE SO GOOD PARTNERSHIP FOR THE LENS COMMUNITY THEY EMPHASIZE THE DEVELOPMENT AS WELL, SO PARTNERSHIP AND MODEL OF CELL BIOLOGY, SO THERE'S POSSIBILITIES ACROSS. >> SO WE HAVE INCREDIBLE NUMBERS OF PARTNERSHIPS. WITH ALL THESE INSTITUTES. FORMAL BILL, NIA IS FLUSH WITH MONEY, USED TO BE OUR PARTNERSHIP WITH THEM WAS ALWAYS IN THAT DIRECTION. BUT NOW WITH THE ALZHEIMER'S MONEY THEY HAVE LOTS OF MONEY AND THEY OFFERED A MINUTE INVESTIGATIVE SUPPLEMENTS TO GRANTS FOR PEOPLE WHO WANT TO WORK ON AGING ISSUES IN OTHER SYSTEMS. WE SEND THEM QUITE A LIST OF GRANTS EVERY YEAR AND THEY HAVE FUNDED EVERY SINGLE ONE OF THEM. SO WE HAVE DONE VERY, VERY WELL WITH THESE PARTNERSHIPS. THE IDEA GRANT PROGRAM IS ALSO EXTREMELY SUCCESSFUL. THEY PICK UP GRANTS ON THE MARGINS BUT THEY WILL FUND TWO OF THREE YEARS WHICH LETS US LEVERAGE OUR MONEY VERY WELL. WOE TAKE ADVANTAGE OF THOSE THINGS. THE CENTRAL OD OFFICES THE OFFICE OF WOMEN'S HEALTH RESEARCH IS ALSO VERY GOOD AT PROVIDING SUPPLEMENTAL FUNDS AND DIETARY OFFICE OF DIETARY SUPPLEMENTS IS ALSO A BIG CO-FUNDER OF OUR GRANTS. WE REALLY PAY ATTENTION TO THESE THINGS AND PICK UP ALL THE POSSIBLE FUNDING THAT WE CAN. >> WITHIN A FUNDED AND PLACATION IF YOU WISH TO ADD AN ELEMENT THAT HAS TO DO WITH AGING MICE FOR EXAMPLE OF A PARTICULAR STRAIN, THAT ANY -- NIA MAINTAINS A COLONY OF YOU CAN WRITE A SUPPLEMENT APPLICATION AND IT WOULD GO INTO THE NEI AND THEN GET SENT TOP THE NIA IS THAT HOW IT WORKS? IF THE GRANT IS COMING FUNDED FROM THE NEI. BUT YOU WANT TO USE AGING. (OFF MIC) >> OKAY. THANK YOU. WHY DON'T WE BREAK FOR LUNCH AND RECONVENE ABOUT LIKE 12:50. I MEAN 1:50. GOING BACK IN TIME. SO LIKE 1:50 WE'LL BE BACK. WE ONLY HAVE SIX ITEMS FOR THE CLOSED SESSION.