>> GOOD MORNING, EVERYONE. WELCOME TO THE SECOND DAY OF THE 115th MEETING OF THE NATIONAL INSTITUTES OF HEALTH'S ADVISORY COMMITTEE TO THE ACD. NICE TO SEE YOU BRIGHT & CHIPPER THIS MORNING AND MANY THANKS TO CHILDREN'S INN FOLKS TO MAKE IT POSSIBLE TO SEE WHAT WE'RE DOING ON THE TOUR AND HAVE A NICE DINNER TOGETHER. WE HAVE A HALF DAY BUT IT'S A VERY FULL HALF DAY IN TERMS OF CONTENT AND THAT MEANS WE'RE GOING TO COUNT ON YOU ACD MEMBERS AND WE'LL START NEXT WITH THE NEXT GENERATION RESEARCHERS INITIATIVE AND THEN HEAR FROM NORAH VOLKOW TO HEAR ABOUT THE STATE OF THE SCIENCE FOR OPIOIDS WHICH WE TALKED A BIT ABOUT YESTERDAY BUT NORAH WILL BRING US ADDITIONAL INFORMATION AROUND 10:45 AND LARRY WILL FINISH US OFF WITH AN A DESCRIPTION OF WHAT'S HAPPENING IN THE RE-IMAGINED HHS EFFORT IN TERMS OF IMPROVING EFFICIENCIES OF OUR OPERATIONS AND WE'LL AIM TO FINISH ON TIME BY 12:15 BECAUSE I KNOW MANY PEOPLE HAVE TRAVEL THINGS THEY NEED TO GET TO. BEFORE WE GO TO THE FIRST TOPIC, I DID WANT TO INTRODUCE ONE MORE PERSON WHO WASN'T ABLE TO BE HERE YESTERDAY BUT IS HERE. OUR NEW DIRECTOR OF THE NATIONAL CANCER INSTITUTE FROM THE UNIVERSITY OF NORTH CAROLINA WHERE HE RAN THE LINEBERGER CANCER CENTER AND RESEARCHER IN HIS OWN RIGHT AND STUDYING CANCER AND AGING. NED SHARPLESS, STAND UP AND BE RECOGNIZED. WE'RE TRIARE THRILLED TO BE HERE AND WE KNOW THE NCI IS IN GREAT HAND AND IT'S BEEN FANTASTIC TO WORK WITH YOU ON MANY FRONTS. I HAVE NO OTHER OPENING REMARKS TO MAKE AT THIS POINT. I WANT TO VERY MUCH EXPRESS MY THANKS TO LARRY TABAK AND JOSƒ FLOREZ FOR HAVING DONE A LOT OF HARD WORK FOR THE PAST SEVERAL WEEKS TO PREPARE FOR THE NEXT GENERATION RESEARCHERS INITIATIVE. OF THE MEMBERS OF THE WORKING GROUP HAVE JOINED US IN PERSON. LARRY WILL CALL THEM OUT AT SOME POINT. I WANT TO SAY MY GRATITUDE TO MIKE LAUER WORKING INTENSIVELY ON THE EFFORT WE DO IN AN AMBITIOUS AND HARD-WORKING WAY AND REQUIRES HARD WORK FROM IMPLEMENTATION PURPOSE. MIKE HAS BEEN PUTTING A LOT OF HIS TIME AND ENERGY AND PASSION INTO THAT. THERE COULD HARDLY BE A TOPIC OF GREATER IMPORTANCE THAN MAKING SURE WE'RE PROVIDING A PATHWAY FOR THE BEST AND BRIGHTEST OF THE NEXT GENERATION TO FIND THEIR PATH IB A DIRECTION THAT'S GOING TO ALLOW THEIR VISION AND DREAMS TO HAPPEN AND FOR SCIENCE TO BENEFIT AS A RESULT. I THINK WE'LL ALL BE INTENSELY WATCHING THIS PRESENTATION AND I'LL TURN IT OVER TO LARRY. >> THANK YOU, FRANCIS. GOOD MORNING, EVERYBODY. LET ME SAY FROM THE OUTSET THIS IS TRULY A TEAM SPORT AND I'LL TRY TO ACKNOWLEDGE EVERYBODY ALONG THE WAY BUT IT'S A TREMENDOUS GROUP EFFORT. WE'RE PLEASED TO PROVIDE AN INTERIM CHECK-IN. SO THE GOAL HERE WILL BE TO PROVIDE INTERIM RECOMMENDATIONS TO THE ACD IN THE JUNE MEETING. WE WANTED TO CHECK-IN WITH YOU THIS MORNING ABOUT THE EFFORTS. SO HOW IS THIS ALL EMBEDDED WITHIN THE CULTURE OF NIH SOME MAY RECALL THIS IS THE FRAMEWORK FOR THE NIH-WIDE OVERVIEW AND HOW WE SET PRIORITIES AND THE WAY WE ENHANCE STEWARDSHIP AND MANAGING FOR RESULTS. SO UNDER THAT, THE UNDERLYING PRINCIPLES ARE THREE POINTS. EACH OF WHICH ARE VERY INVOLVED WITH AND INTEGRATED TO THE NEXT GENERATION INITIATIVE. THE FIRST IS TO THE WORKFORCE AND ONE OF THE WORKING GROUP MEMBERS REMINDED ME WE NEEDED TO ALSO ENCOURAGE INNOVATION BECAUSE SO MUCH OF THE INNOVATION COMES FROM THE NEXT GENERATION EVEN BEFORE THE NEWLY-MINT NEWLY-MINTED PROFESSORS. THAT'S IN HERE AS WELL AND EQUALLY IMPORTANT. THIS ALL BEGAN WITH A POLICY STATEMENT WITH THE NEXT GENERATION OF THE POLICY RESEARCHERS INITIATIVE. I PUT THIS UP FOR HISTORICAL COMPLETENESS BECAUSE WE DEFINE TWO DIFFERENT TYPES OF INVESTIGATORS AND THE ACRONYMS WILL COME UP THROUGHOUT THE DISCUSSION. JUST TO MAKE SURE THE WHOLE ACD IS ON THE SAME PAGE TO REMIND YOU, EARLY STAGE INVESTIGATORS WERE DEFINED AS A PROGRAM DIRECTOR OR PRINCIPLE INVESTIGATOR WHO COMPLETED THEIR END OF POST-GRADUATE CLINICAL TRAINING WITHIN THE PAST TEN YEARS. THAT'S WHAT WE HAD BEEN FRAMING AS AN E.S.I. THE EARLY-ESTABLISHED INVESTIGATOR, E.E.I, IS WITHIN 10 YEARS COMPLETING RO1 EQUIVALENT AS AN E.S.I. SO THERE WAS A LINKAGE THROUGH THAT E.E.I. BEING A FORMER E.S.I. AND THOSE WERE THE DEFINITIONS WE WERE WORKING WITH. THERE WAS INTENTION DISCUSSION ABOUT THIS IN THE SCIENTIFIC COMMUNITY AND THAT WAS A BIT OF AN UNDERSTATEMENT. I CAN DO A ROUGH INDEX OF HOW MUCH PEOPLE ARE INTERESTED IN THINGS BY THE NUMBERS OF E-MAILS THEY GET PER MINUTE. AND WHEN YOU DO THAT CALCULUS IT WAS ONE OF THE MOST INTENSELY DISCUSSED SET OF ISSUES DURING MY TENURE AS A DEPUTY DIRECTOR. SO AS IS TRUE IN MANY INSTANCES WHEN WE ARE FACED WITH A VERY GNARLY AND SIGNIFICANT ISSUE, FRANCIS TURNED TO YOU, THE ACD, AS THE PEOPLE TO HELP US THINK THROUGH THIS AND TO INFORM THE ACD IN DISCUSSIONS AND CREATE A WORKING GROUP THE NEXT GENERATION INITIATIVE WORKING GROUP, THE NGRI AND THIS WAS ANNOUNCED AND ALSO, PARENTHETICALLY, NOW EMBEDDED IN THE 21st CENTURY CURES LEGISLATION. NOW, SOMEWHAT CONVENIENTLY THE INITIATIVE IS NOW SIGNED TO HELP US DESIGNED TO HELP US MEET THE LEGISLATION. NOW, THIS INCLUDES GRADUATE STUDENTS TO PROFESSORS IN DIFFERENCE INSTITUTIONS AND THEY'RE MULTI-DISCIPLINARY AND WORKING ALL KINDS OF DISCIPLINES. HERE ARE THE MEMBERS OF THE GROUP. AMY ELLIOTT IS HERE TODAY AND JOSƒ FLOREZ A MEMBER OF THE ACD, AND LINDA GRIFFITH, MIKE LAUER WHO YOU ALL KNOW AND OTHER MEMBERS WHO ARE NOT PRESENT BUT I HOPE WILL JOIN US BY PHONE OR WATCHING ON THE WEB. JOHN WARSH IS HERE AND JUAN PABLO WHO IS A GRADUATE STUDENT IS HERE, ELBA A MEMBER OF ACD STUCK WITH ME. YOU SEE THE REMAINING MEMBERS OF THE GROUP. I HAVE TO SAY, HAVING CHIRRED MANY WORKING GROUPS OVER THE YEARS THIS HAS BEEN A UNIQUE GROUP AND THE REASON IT'S SO UNIQUE IS THE PASSION AND ENERGY AND THE ABSOLUTELY UNIQUE INSIGHTS THAT HAVE BEEN PROVIDED BECAUSE OF THE RANGE OF INDIVIDUALS THAT WE HAVE INCLUDED IN THIS PROCESS. AND I THINK THERE ARE LESSONS TO BE LEARNED HERE AS WE CREATE OTHER COMMITTEES GOING FORWARD THAT NOT EVERYBODY ON A COMMITTEE SHOULD BE A GRAY HAIR. SO KEEP THAT IN THE BACK OF YOUR MIND. THIS IS THE CHARGE TO THE WORKING GROUP AND I WILL NOT READ THROUGH THIS WHOLE LIST OF THINGS. SOME CAN READ IT QUICKER THAN I CAN, BUT BASICALLY WE WANT THE WORKING GROUP TO ADVISE THE LEADERSHIP ON A POLICY THAT WILL WORKING GROUP, THEY'LL FEED THEIR RECOMMENDATIONS TO THE ACD AS A WHOLE. THE ACD WILL WRESTLE, MAKE COMMENTS, MAKE RECOMMENDS AND SO FORTH ULTIMATELY PROVIDING FRANCIS WITH RECOMMENDATIONS. AS I SAY, THERE MAY BE INTERIM STUFF FOR THE NEXT MEETING IN JUNE BUT FINAL RECOMMENDATION AND IS THIS AN AREA WHERE YOU NEED AN ONGOING PRESENCE OR WILL THEY NEED TO MAKE A MEETING. AND IN TERMS OF A TACTICAL ERROR, IT'S ONE OF THE BIGGEST TACTICAL ERROR I'VE MADE IN MY CAREER. SO THIS SAY TEACHING MOMENT. WHEN YOU FORM A NEW WORKING GROUP YOU HAVE TO GET IN A ROOM TOGETHER, FACE TO FACE. SO I SCREWED THIS UP ROYALLY AND WE DID THIS INSTEAD BY TELEPHONE. WE HAD A SERIES OF MEETINGS. THE FIRST WERE COMPLICATED AND IT TOOK A WHILE TO GET A CADEN -- CADENCE AND WE HIGHLIGHTED THE AGING OF THE SCIENTIFIC WORKFORCE IS PARTICULARLY AMONG INDIVIDUALS AND MORE RAMPANT IN A WORKFORCE AS A WHOLE AND THIS IS WORK BY WINEBERG THAT'S BEEN PUBLISHED. WE HIGHLIGHTED THE NUMBER OF RO1 GRANTEES THAT ARE YOUNGER HAS DROPPED AND HIS IS PUBLISHED BY LOVETT AND LOVETT AND IT REMAINS DIFFICULT FOR JUNIOR INVESTIGATORS TO GET THEIR FIRST COMPETING RENEWAL. AND THIS IS SOMETHING ALL OF YOU SEATED AROUND THE ACD TABLE KNOW BECAUSE YOU ARE JUNIOR COLLEAGUES STRUGGLING IN YOUR INSTITUTIONS AND SOMETHING THE MEMBERS OF THE WORK BEING GROUP UNDERSTAND AND SOME ARE LIVING IT IN REAL TIME. THERE WAS NO JUDGMENT OFFERED IT WAS LOOKING THROUGH THESE AS OPTIONS. HOW CAN WE POSSIBLY USE METRICS AND CAME TO REALIZE THE CURRENT POLICY'S ONLY A GUIDE AND MUCH OF IT DEPENDS ON THIS INSTITUTES AND CENTERS FOR THE FINAL IMPLEMENTATION. THERE WAS THIS SORT OF REALITY TESTING MEANING THERE ARE NO ADDITIONAL FUNDS TO IMPLEMENT NGRI AND FRANKLY THE MEMBERSHIP EXPRESSED CONCERN ABOUT HOW IF YOU UNCOUPLE POLICY GOALS FROM THE MEANS TO ACHIEVE THOSE GOALS YOU MAY BE UNDERMINING YOUR ABILITY TO DO THAT AND IT'S NOT AN UNFAIR OBSERVATION. AND THE NUMBER OF INVESTIGATORS RATHER THAN THE NUMBER OF GRANTS. THIS IS SOMETHING INTERNALLY AT NIH WE'VE HAD PARALLEL CONVERSATIONS ABOUT. AND I KNOW JOHN MARSH OR MIKE LAUER CAN EXPOUND ON THAT IF ANYBODY'S INTERESTED. AND FINALLY WE HAD TO SHIFT AWAY FROM GRANT INDEXES. WE FLOATED THE NOTION WE'D GIVE SOME SORT OF METRIC VALUE TO THE TYPES OF GRANTS INDIVIDUALS HELD. AND BECAUSE OF AVERAGE PRODUCTIVITY MEASURES WE FELT YOU REACH A POINT OF DIMINISHING RETURNS AND IT WAS PROBABLY IMPORTANT TO LIMIT OF GRANT-SUPPORTED POINTS SO PEOPLE IN THAT AREA WHERE THEY WERE STILL BEING PRODUCTIVE BUT WEREN'T BEING AS PRODUCTIVE AS SOMEBODY WHO GOT THEIR FIRST OR SECOND GRANT IT PROPERLY MADE SENSE TO SHIFT FUNDS. THIS PROVED TO BE VERY POPULAR WITH SOME PEOPLE AND VERY UNPOPULAR WITH OTHER PEOPLE. I THINK THAT'S A FAIR CHARACTERIZATION AND WHAT THE COMMITTEE REALIZIZED REALIZED WE INTO TO LOOK AT THE RISK FOR LOSING ALL FUNDING SUPPORT. THAT'S A VERY IMPORTANT SHIFT. IN OTHER WORDS, RATHER THAN TALK ABOUT E.S.I.s OR E.E.I.s OR OTHER WAYS OF SLICING AND DICING THIS, CONSIDER WHO ARE THE INVESTIGATORS WHO ARE AT RISK FOR LOSING ALL FUNDING SUPPORT. ARE THOSE THE PEOPLE THAT YOU REALLY NEED TO FOCUS YOUR ATTENTION ON AND PERHAPS IN A MORE AGNOSTIC MANNER THAN E.E.I.s AND TALKING ABOUT AN E.S.I. THAN WHAT A HOST WOULD ALLOW TO YOU DO. THE GROUP ARTICULATED A SERIES OF GENERAL POLICY GOALS AND I WOULD SAY THESE ARE PRELIMINARY BECAUSE GOOD-BYE, THIS IS A CHECK-IN MEETING, THOUGH I THINK THE THINKING ON THESE IS FAIRLY MATURE AND I'D BE SURPRISED IF THEY CHANGED. CLEARLY THERE'S A NEED TO PROTECT JUNIOR INVESTIGATORS. THERE'S AN EQUALLY IMPORTANT DO NO HARM. IT'S SO IMPORTANT TO MITIGATE THE UNINTENDED CONSEQUENCES SO ANYTHING WE'VE PROPOSED TO DO HAS BEEN VETTED AND EVIDENCE BASED AND WE HAVE TO BE ABLE TO MONITOR AND RE-EVALUATE POLICIES IN REAL TIME BECAUSE TIMES THE CONSEQUENCE DOESN'T MANIFEST UNTIL AFTER THE FACT BECAUSE YOU NEVER THOUGHT OF IT BEFORE DESPITE THE MODELLING AND THINKING THROUGH OF DISCUSSION AND SO FORTH. SO THERE ARE A FEW ADDITIONAL THEMES FROM THE TELEPHONE CONFERENCES. THE COMMITTEE HATED ESI -- E.S.I. AND E.E.I. DEFINITIONS. AND YOU PRIORITIZE INVESTIGATORS AT HIGHEST RISK. ARE THOSE EARLY STAGE INVESTIGATORS OR FOLKS DEPENDENT ON A SINGLE RO1 AND WE NEED MORE PREDICTIVE MODELS TO MORE CAPTURE WHO IS AT RISK. WE CAN DO SOME OF THIS BUT WE CAN DO A BETTER JOB GOING FORWARD. AND THIS WAS SUBSEQUENTLY VALIDATED AND THERE WAS A SENSE DURING THE EARLY CONVERSATIONS THAT MID STAGE INVESTIGATORS MAY BE PUT AT GREAT RISK AND INTEEST WAS A WHOLE NEW GROUP AT RISK AND THAT'S A VERY GOOD EXAMPLE OF UNINTENDED CONSEQUENCES DESPITE EVERYBODY'S GOOD INTENTION YOU HAVE TO BE CAREFUL ABOUT. WE THEN HAD OUR FIRST FACE TO FACE MEETING IN NOVEMBER, WHICH WE SHOULD HAVE HAD UP JULY. HERE'S WHAT WE TALKED ABOUT AND AGAIN, AND I HAVE TO THANK JOSƒ, MIKE AND Y FOR CARRYING THE DAY BECAUSE I GOT CALLED TO A MEETING WITH FRANCIS. NEVERTHELESS, THERE WERE SOME IMPORTANT TOPICS. SO JOHN GAVE A SYNOPSIS OF THE PAST ISSUES AND HANNAH AND ELDWIN GAVE AN IMPORTANT PRESENTATION ABOUT THE INTERSECTION BETWEEN WHAT THE NEXT GENERATION RESEARCHERS INITIATIVE IS DOING AND WHAT THE WORKING GROUP ON DIVERSITY IS DOING. AND THIS WORKING GROUP, NGRI WORKING GROUP HAS COMPLETELY AND TOTALLY EMBRACED THE NEED FOR DIVERSITY IN EVERYTHING THEY'RE THINKING ABOUT. SO THAT WAS A VERY SUCCESSFUL PRESENTATION. WE THEN VIN -- INVITED A DOCK FOR FROM UNC TO OFFER HIS PERSPECTIVE AND OTHERS WHY WE NEED TO CAP INDIVIDUAL INVESTIGATORS. MIKE LAUER THEN PRESENTED EVIDENCE-BASED METRICS SHOWING THE RANGE OF OPTIONS ONE WOULD HAVE AVAILABLE. NO VALUE JUDGMENTS BUT THE LARGE RANGE OF OPTIONS. WE THEN HAD AN INTERESTING REPORT FROM THE GROUP OF A -- FROM A SUBGROUP OF OUR WORKING GROUP FROM THE NEXT GROUP OF SCIENTIST. I'VE ALREADY INTRODUCED YOU TO AMY AND JUAN AND STEPHANIE PAGE AND TIM REED BOTH PARTICIPATED. THEN GARY GIBBONS AND JIM ANDERSON AND LAURIE EBONELLI OFFERED THE UNIQUE APPROACHES THEY USED TO ENHANCE FUNDING FOR THOSE MOST AT RISK AND APPROACH THEM IN A SLIGHTLY DIFFERENT WAY. AND THEN THERE WAS THE NEXT STEP AND TIME LINE. SO, LET ME NOW REPORT OUT FROM THE FACE TO FACE MEETING. AND THE FIRST PART OF THE FACE TO FACE MEETING WAS -- THIS WAS THE PIECE I WAS THERE FOR. SO NIH RECOGNIZED, AND WE'VE SAID TO THE COMMITTEE AND I'LL SAY TO YOU, WE HAVE TO OWN THAT. AND THE SECOND WAS BECAUSE OF COMMUNICATION COULD HAVE BEEN BETTER. I TAKE RESPONSIBILITY FOR THAT. THERE WAS A LOT OF ANGST DERIVED FROM THE 25% FUNDING TARGET AND PART OF THE MISCOMMUNICATION THAT WAS VERY UNFORTUNATE WAS THIS WAS THOUGHT TO BE A UNIFORM TARGET ACROSS THE ENTIRE NIH. THE REALITY THOUGH IS FOR THOSE WHO LIVE INSIDE NIH KNOW, WHEN YOU'VE SEEN ONE AIC YOU'VE SEEN ONE AIC. THERE'S NO UNIFORM ANYTHING. THAT'S PART OF OUR STRENGTH AND WHAT MAKES NIH GREAT BUT IN THESE INSTANCES IT CAN GET YOU IN A CONUNDRUM. IN NIH WE WERE THINKING THAT OF AN AVERAGE UNDERSTANDING SOME NICs THEIR TARGET WOULD HAVE TO BE 15 AND OTHERS IT WOULD BE 23 OR 25 OR 30 OR -- IT WAS NEVER MEANT TO BE EVERY SINGLE PERSON. SO WE HAVE RECEIVED MANY MANY E-MAILS FROM SOMEBODY WHO WOULD SAY WELL, I RECEIVED A 24th PERCENTILE FROM INSTITUTE X AND AS SOON AS I STARTED RECEIVING THE E-MAILS I KNEW INSTANTLY WHAT THE COMMUNICATIONS MISSTEP WAS. I KNEW VERY WELL WILL INSTITUTE X THEIR TARGET WAS MORE LINE 15% AND THEY'D NEVER REACH IT 24. I HOPE THAT EXPLAINS THIS IN PART. AND WHY DOES THIS VARIATION -- THAT'S VERY COMPLEX AND BASED ON EACH INSTITUTE AND THEIR PARTICULAR STRATEGIES FOR SUPPORTING RESEARCH AND MANDATES AND SO FORTH. WE ALSO ACKNOWLEDGE DURING THE MEETING WE WERE VERY AWARE OF WHAT THE NGRI WAS TALKING ABOUT DURING THE TELEPHONE CONVERSATION. SO WE WEREN'T JUST WAITING TO GATHER EVERYTHING AND LET THE NIH LEADERSHIP NOW. THERE'S BEEN A CONSTANT BI-DIRECTIONAL DIALOGUE AND SOME WERE BEING CONSIDERED AND RATHER THAN ANCHOR THOSE FOR SPECIAL CONSIDERATION AT AN ARBITRARY POINT OF TIME, NIH LEADERSHIP HAS COME TO REALIZE IT WOULD MAKE MORE SENSE TO CONSIDER FLEXIBLE APPROACHES FOR MERITORIOUS INVESTIGATORS MOST AT RISK. YES, WE GET VERBATIM. WE LISTEN. THE SECOND WAS TO REQUIRE E.S.I. FUNDING IN CERTAIN AREAS OF SCIENCE. A GOOD EXAMPLE IS ALZHEIMER'S DISEASE WHERE RICHARD HODIS HAS DONE AN EXTRAORDINARY JOB OF PLOTTING OUT THE OPTIMAL USE OF THE RESOURCES NIA AND NIH AS A WHOLE ENJOY, TO ENSURE THE RESOURCES ARE NOT ONLY FOR ESTABLISHED INVESTIGATORS, BECAUSE IF YOU THINK BIT YOU GET -- ABOUT IT, WHO IS MOST POISED TO JUMP ON THE ANNOUNCEMENT? THE ESTABLISHED INVESTIGATORS. UNLESS YOU SAY, WAIT A MINUTE, WE NEED COMING FROM EARLY-STAGE INDIVIDUALS YOU'LL NEVER GET NEW PEOPLE IN THAT SYSTEM. SO AGAIN, I'M USING RICHARD AS THE EXAMPLE BUT OBVIOUSLY THERE'S OTHER EXAMPLES. AND THIS YEAR WILL BE A STRONGER YEAR FOR IMPLEMENTATION THAN FISCAL YEAR '17. SO FISCAL YEAR '17 BECAUSE WE STARTED IN THE LAST QUARTER OF THE FISCAL YEAR, IT PROVED TO BE CHALLENGING TO MEET TARGETS THAT WERE TALKED ABOUT. AT THE END OF THE DAY WE'LL COME CLOSER TO THE TARGETS IN THE E.S.I. CATEGORY. THE TIME FROM TERMINAL TO DEGREE SEEMED TO BE RESTRICTIVE AND THE UNINTENDED CONSEQUENCES UP OVER AND OVER AGAIN WHEN IMPLEMENTING. E.E.I. DEFINITION TIED TO FORMER STATUS, NOW, I MADE THIS CALMER. IT WAS VIEWED AS TOO RESTRICTIVE. PEOPLE WERE QUITE CONCERNED ABOUT THAT AND FOLKS RAISED THE ISSUE YOU CAN'T JUST DEFINE E.S.I.s AND E.E.I.s IN A MODEL WHERE RESEARCH IS RUN IN AN RO1 GRANT BECAUSE SOME PEOPLE FELT BY FOCUSSING ON SINGLE INVESTIGATORS RO1s, ARE WE REENFORCING SOME BEHAVIOR SOME THINK ARE UNHEALTHY. SO IS THAT SOMETHING WE WANT TO CODIFY AND INCENTIVIZE AND WE UNDERSTAND THERE'S DIFFERENT MODELS AMONG INSTITUTIONS AND NIH WON'T TELL AN INSTITUTION HOW TO RUN THEIR BUSINESS MODEL BUT WE DON'T NECESSARILY HAVE TO THROW KEROSENE ON THE EMBERS. AGAIN, CONTINUING WITH DEFINING SOURCES AVAILABLE TO AN INVESTIGATOR OR RECORDING OR ACHIEVING INDEPENDENT FUNDING MAY BE A MORE ACCURATE WAY TO DEFINE INVESTIGATORS AND OF COURSE AGE SHOULD NOT MATTER. INTERESTINGLY ENOUGH, THIS WAS THE MOST JUNIOR MEMBERS OF THE GROUP REMINDING US AGE SHOULD NOT MATTER. THAT WAS IMPORTANT AND VERY HEALTHY. I MENTIONED THIS A FEW MOMENTS AGO, JOHN MARSH AND HIS COLLEAGUES REVIEWED MODELLING DATA ACROSS ALL OF NIH TO ASSESS THE EFFECT OF NIH ATTEMPTING TO REACH E.S.I. AND E.E.I. TARGETS AND THAT RESULT IS A WASH. IN ORDER TO REACH TARGETS AS MUCH AS MERITORIOUS INVESTIGATORS WOULD LOSE FUNDING AS E.S.I.s WOULD RETAIN. I HAVE TO SAY, THOUGH SOME PEOPLE REALIZE THIS INTUITIVELY FROM THE BEGINNING. IN EVERY MATH CLASS WHEN THE PROFESSOR SAID INTUITIVELY YOU KNOW THIS, THAT'S WHERE I GOT LOST. AND INDEED, THE PROBLEM HAS IMPROVED A LITTLE BIT BY NOT PRIORITIZING FUNDING IN THE SECOND GRANT BUT YOU STILL HAVE A WHOLE GROUP OF FOLKS WHO AREN'T STRICTLY SPEAKING E.S.I.s AND E.E.I.s AND LOSE EVERYTHING AND SO IT MATTERS WHERE YOU GET THE FUNDS FROM AND UNTIL I SAW THE MODELLING I DIDN'T APPRECIATE IT BUT SURELY DO NOW. I THINK THE COMMITTEE RESONATED WITH THIS SO BY NOT TARGETED THE SOURCE OF FUNDS, NIH MAY HARM THE GROUP OF INVESTIGATORS WE'RE TRYING TO THEN SO SOMETHING TO KEEP IN MIND. NOW FROM OUR NEXT-GEN COLLEAGUES, MORE CLARITY IS NEEDED ON HOW THE POLICY IS BEING I MPLEMENTED. THIS IS SOMETHING WE HAVE TO COME TO GRIPS WITH. WE HAVE TO REBUILD THE TRUST. I HOPE IT RESTARTS TODAY BUT WE HAVE TO REBUILD THAT TRUST. WE HAVE TO PLACE MORE ATTENTION ON THE MEANINGFUL COLLABORATION BETWEEN SENIOR AND JUNIOR INVESTIGATORS. THE NOTION THAT JUNIOR INVESTIGATORS ARE LABORERS AND WE TALKED ABOUT THIS YESTERDAY ABOUT WHAT THE REAL COSTS ARE IN OUR SYSTEM WHEN YOU THINK ABOUT POST-DOCS AND WE NEED TO CONSIDER THE MORE JUNIOR INDIVIDUALS AS COLLEAGUES AND NOT PEOPLE WHO DO THE WORK, AS IT WERE. AND THIS CAME UP OVER AND OVER. NGRI MUST BE CLOSELY TIED TO MINORITY AND WOMEN AND INVESTIGATORS FROM REGIONALLY DIVERSE AREAS AND INSTITUTIONS BECAUSE IF WE CAN'T ACHIEVE THAT WE CAN ELIMINATE LARGE SECTIONS OF THE COUNTRY. AND NOT INCLUDE LARGE NUMBERS OF INSTITUTIONS. WE NEED MORE DATA. THIS GROUP CAME TO THE RIGHT PLACE. HOW MANY INVESTIGATORS CAN YOU SUSTAIN LONG TERM. IT'S SUCH A FUNDAMENTAL QUESTION BUT I DON'T THINK ANY OF US HAVE A READY ANSWER FOR THAT. WE CAN DO BACK OF THE ENVELOPE CALCULATIONS. IT'S CLEAR THE GROUP FEELS WE NEED MORE TRANSPARENCY AND BALANCE IN THE DATA PRESENTATION. PART OF THE ANGST IN THE COMMUNITY IS NOT ALL THE DATA WERE READILY AVAILABLE OR AVAILABLE IN A WAY THAT WAS EASILY ACCESSED. SOME POINTS ABOUT THIS, WHEN WE THINK OF NIH FUNDING MOST THINK OF ACADEMIC HEALTH CENTERS, SCHOOLS OF MEDICINE. OBVIOUSLY WE FUND INVESTIGATORS AND MANY OTHER TYPES OF INSTITUTIONS WHO PROVIDE ENORMOUS CONTRIBUTION TO WHAT WE DO. WE HAVE TO MAKE SURE THOSE ARE CONSIDERED. WE NEED MORE CLARITY ABOUT THE GAPS IN THE DATA AND ABOUT IMPORTANT TRENDS THAT CAN EXERT A LARGE INFLUENCE ON DATA INTERPRETATION. THE BEST EXAMPLE IS SCIENCE. TEAM SCIENCE IS NO LONGER BOW BOUTIQUE. IT'S HOW IT'S BECOME OF BEING DONE AND HOW DOES IT BENEFIT INVESTIGATORS EARLY IN THEIR CAREER OR NOT. SO IF YOU'RE THE 14th MEMBER OF THE BIG TEAM, DOES THAT BENEFIT YOU OR NOT AND IT COULD BUT IT MAY NOT AND THEN WE HAVE SOME NEW APPROACHES AT NIH TYPIFIED BY THE AWARDS AND WHAT EFFECT HAS THE SHIFT TO SHIFT TO THOSE AWARDS WHICH PROVIDE MORE STABILITY BUT SLIGHTLY LESS FUNDING THAN THE FOUR RO1s THEY WERE SEEKING, WHAT EFFECT DOES THAT HAVE? PRODUCTIVITY ASSESSMENTS. WE CAN CONSIDER PRODUCTIVITY BUT ONLY IF WE LOOK AT MULTIPLE LEVELS AND INDIVIDUAL, INSTITUTIONAL AND GLOBAL AND CONSIDER THE LIMITS AND IT HAS TO GO BEYOND PUBLICATIONS AND THERE ARE OTHER METRICS LISTED HERE YOU CAN READ FOR YOURSELF. ADDITIONAL DATA QUESTIONS. WHAT CORRELATION IS THERE BETWEEN MORE EXPERIENCED WELL-FUNDED INVESTIGATORS AND LESS EXPERIENCED POORLY-FUNDED INVESTIGATORS IN TERMS OF SERVICE TO NIH. THERE'S A VIEW THAT CERTAIN GROUPS OF INVESTIGATORS TAKE ON THE SHARE OF THE SERVICE WORK, NOT THIS GROUP. YOU GUYS ARE ALL WONDERFUL. THANK YOU FOR SERVING, EVERY ONE OF YOU. THAT WAS AN ADVERTISE MANY BUT IT'S TRUE. BUT THERE IS THIS CONCERN THE MOST SENIOR INVESTIGATORS, THE REAL OUTSTANDING PEOPLE THAT EVERYBODY LOOKS TO, THEY MAY NOT BE SERVING IN PROPORTION TO THE RESOURCES THAT THEY ENJOY AND THEN THERE'S A QUESTION WHICH WE HAVE TACKLED OVER AND OVER AND OVER AGAIN AT NIH BARB, YOU'LL LIKE THE ANSWER, SHOULD WE CONSIDER A MANDATORY LEVEL OF SERVICE PROPORTION TO THE WORK. PROBABLY WE CAN'T DO THAT AND BARBARA IS LOOKING LIKE, YEAH, OKAY. THAT'S MY REALITY CHECK BUT ANYWAY, IT WAS RAISED SO I'M REPORTING IT OUT TO YOU. WE NEED A BETTER UNDERSTANDING OF BUSINESS MODELS BECAUSE WHEN YOU'VE SEEN ONE INSTITUTION, YOU'VE SEEN ONE INSTITUTION. HOW DOES THE DIVERSITY OF BUSINESS MODELS INFLUENCE PRODUCTIVITY AND THERE'S DIFFERENT PRODUCTIVITY. THERE'S A COST OF LIVING DIFFERENCE. RODCHESTER, NEW YORK, WASHINGTON, D.C. THERE'S A DIFFERENCE IN THE COST OF LIVING. I'M POSITIVE. THEN WHAT PERCENTAGE OF NIH INVESTIGATORS RECEIVED A PERCENTAGE OF THEIR SALARY. IN OTHER WORDS, ARE SOME MODELS DRIVING THEM TO GET ALL THEIR MONEY, WE KNOW THE ANSWER IS YES BUT WE'D LIKE TO HAVE THE DATA. VERSUS SOMEBODY WHO HAS -- SAY YOU HAVE 80% OF YOUR SALARY, IS IT FROM TWO OR THREE GRANTS OR 15 GRANTS BECAUSE YOU'RE RUNNING A POOR FACILITY. AND THEY ALL MAKE THE ANALYSES MORE CHALLENGES. SOME PEOPLE SAID WHY DON'T WE THINK OF A PRODUCTIVITY SECTION. IT'S A SUGGESTION. WE'RE NOT SAYING IT'S A REQUIREMENT. SOME RAISE ISSUES ON PRODUCTIVITY METRICS TO MAKE HIGHLY GRANULAR DECISIONS. EVERYBODY WAS COMFORTABLE LOOKING AT TREND ANALYSIS. AND WHAT THEY DO ABOUT TEAM SCIENCE AND TENURE BUT IT MAKES A DIFFERENCE IN HOW INVESTIGATORS BEHAVE AND THERE'S A SHIFT IN DEMOGRAPHICS. THIS IS A GOOD THING, PARTICULARLY THE BRAIN INITIATIVE. I'VE BEEN IMPRESS WITH THE NUMBER OF MATHEMATICIANS AND WE NEED MORE OF THESE PEOPLE, THIS IS WONDERFUL, BUT HOW'S THAT CHANGE THE GAME? AND THEN TO EXAMINE THE MANDATE ON VULNERABLE INVESTIGATORS ASSESS FUNDING RATE OF E.E.I. SO THE SUCCESS RATE OF THE ESTABLISHED INVESTIGATORS. AGAIN, LOOKING AT THE PERSON. SO THERE WAS AN ACKNOWLEDGEMENT CERTAIN APPROACHES WERE WORKING. PROGRAMS THAT FOCUS ON THE ACCOMPLISHMENTS RATHER THAN THE PROJECT PER SE AND HERE I THINK THEY WERE THINKING ABOUT THE MIRROR AWARD AND AWARDS LIKE THAT. PRIORITIZE PROJECTS THAT FILL A CRITICAL GAP IN AN I.C. STRATEGIC PLAN. SHOULD THERE BE AN ADVISORY COMMITTEE FOR OVERSIGHT AND MENTORING OR DO MORE SELECT PAY WITH THE CAVEAT IF YOU'RE NOT CAREFUL YOU CAN INJURY THE VERY PEOPLE YOU WANTED TO HELP. THEY ACKNOWLEDGED BRIDGE AWARDS IS AN APPROACH. A BRIDGE AWARD IS BETTER IN THAN NOT HAVING ANY FUNDING. IT DEPENDS ON THE REVIEWS AND EARLY STAGE AND APPARENTLY WE DON'T DO THIS UNIFORMLY AND IT IS SOMETHING WE CAN DO MORE UNIFORMLY. HERE IS A SUMMARY OF THE PROGRESS TO DATE. I THINK WE HAVE ACHIEVED A MILESTONE OF INCLUSIVENESS IN ESTABLISHING ONE OF THE MOST DIVERSE WORKING GROUP -- I THINK IT'S THE MOST DIVERSE WORKING GROUP AND I THINK IT'S A GOOD THING. I THINK WE MADE GOOD PROGRESS IN SHARPENING WHAT ARE A SERIES OF SHARED UNDERSTANDING OF PROBLEMS AND POTENTIAL PATHS FORWARD. AND I THINK WILL HELP US RE-ESTABLISH A WORKING GROUP AND THERE'S A SHARED UNDERSTANDING OF WHAT THE POTENTIAL WOULD BE FOR UNINTENDED NEGATIVE CONSEQUENCES OF A POLICY CHANGE. AND WE'VE CLEARLY MADE SUBSTANTIAL PROGRESS IN REFINING WHAT THE FOCUS OF A POLICY SHOULD BE. NOT ON E.S.I. OR E.E.I. BUT RATHER PEOPLE AT RISK. WE HAVE SORT OF MADE THAT TIPPING POINT. SO WHAT ARE THE NEXT STEPS? SO AGAIN, THIS IS JUST MEANT TO BE AN INTERIM REPORT. THERE ARE NO REAL RECOMMENDATIONS THOUGH YOU CAN DISSECT SOME OF THEM NOW ALREADY. WE'LL GIVE YOU MORE RECOMMENDATIONS IN JUNE. WE HAVE TO CONTINUE TO DEVELOP SHORT-TERM AND LONG-TERM METRICS AND THERE'S A GROUP HAS SET A GOAL OF RECOMMENDATIONS SUSTAINABILITY NOT JUST ACROSS I.C.s AND TYPES OF INSTITUTION AND FIELDS OF RESEARCH, BUT CROSS TIME. THAT'S A HEAVY LIFT BUT I THINK THEY GOT IT RIGHT. THEY'RE GETTING IT RIGHT. SO WITH THAT, I JUST WANTED TO MENTION IN ADDITION TO THE EXTRAORDINARY WORK OF THE WORKING GROUP AND IN PARTICULAR, OER AND MIKE LAUER AND JOHN AND ALL THE STUFF YOUR FOLKS HAVE PROVIDED AND GARY, THANK YOU FOR BEING ON THIS AS WELL, SHOSHAUNA HELPED WITH THAT AND WITH THAT AIL -- I'M OPEN IT FOR DISCUSSION. AND THERE'S FOLKS BY PHONE AND THE ARRANGEMENT IS SOME FOLKS WILL E-MAIL ME RATHER THAN ALL JUMP IN AND WE'LL START WITH ACD MEMBERS. >> THANK YOU FOR A VERY CLEAR AND INFORMATIVE PRESENTATION. I'D LAKE TO REFER TO JOSƒ, YOUR CO-CHAIR AND SEE WHAT COMMENTS HE WANTS TO ADD. >> AS THE CO-CHAIR OF THE GROUP AND I AGREE BECAUSE IT WAS A CONSENSUS STATEMENT. I THINK YOU WERE A LITTLE TOO HASH -- HARSH ON YOURSELF AND THERE WERE TWO DRIVING FORCES ONE WAS THE URGENCY OF THE TOPIC AND THE TURM OIL IT CAUSED IN JUNE AND THE COMMITMENT TO MAKE SURE THE GROUP WAS REPRESENTATIVE. GIVEN THE URGENCY AND DIVERSITY IT WASN'T AN EASY TASK TO CONVERGE US AND GET US TO DISCUSSION. THERE WERE A FEW HICCUPS BUT YOUR ABILITY TO MANAGER THE GROUP AND NAVIGAE AND PROVIDE A SAFE FORUM FOR VOICES TO BE HEARD AT THE SAME TIME WITH SOME REALISM HAS BEEN INSPIRATIONAL SO THAT'S ONE POINT TO MAKE. THE SECOND POINT I'D LIKE TO MAKE ECHOS BUT I WANT TO EMPHASIZE WHAT LARRY SAID, IF THERE'S ANY DOUBT IN ANYBODY'S MIND, DIVERSITY CROSSES MANY AXES AND IT MAKES A MUCH MORE RICH AND PRODUCTIVE DISCUSSION WITH MANY PERSPECTIVE I THINK WE WERE MISSING IN THE SPRING WHEN THE ACD WAS CONSIDERING A SIMILAR ISSUE. IN PARTICULAR, I THINK THE YOUNG PEOPLE IN THE GROUP HAVE BEEN SO INSPIRATIONAL TO SEE HOW THOUGHTFUL, ARTICULATE AND SEE HOW WELL INFORMED THEY ARE AND REPRESENT A NUMBER OF PEOPLE ACROSS THE COUNTRY SO THEIR CONTRIBUTION IS PARTICULARLY VALUED AND I AGREE ON THE FOCUS ON PEOPLE RATHER THAN GRANTS AND EXPANDING THE DEFINITION TO A VULNERABLE AT-RISK GROUP OF INVESTIGATORS THAN ARBITRARY GRUP OF -- GROUP OF PEOPLE AND HAVE SCIENTIFIC VIGOR BECAUSE WE CARE ABOUT FACTS AND DATA. OUR DESIRE TO NOT HAVE ALTERNATIVE CONSEQUENCE AND MORE TIME ALLOCATED TO THIS THAN WHAT WAS DONE IN THE SPRING IS THOUGHTFUL AND TO CONTINUE TO MONITOR THE POLICIES FOR DESIRED EFFECT RIGHT ON TARGET. >> I'M SURE ACD MEMBERS HAVE QUESTIONS STARTING WITH BRANDON. >> FIRST, I WANT TO THANK THE WORKING GROUP. I THINK THIS IS A VERY DIFFICULT TOPIC AND IT'S AKIN TO TRYING TO TAKING A $2 TRILLION TAX CUT AND AT THE SAME TIME IT'S TRYING THE FEDERAL RESERVE TRYING TO MANIPULATE THE ECONOMY WITH JUST AN INTEREST RATE. ONE POINT I'D LIKE TO MAKE IS THE EXPECTATION WITH DIVERSE REPRESENTATION IS AT THE END OF THE DAY IT WILL BE SOME THINGS TO ALL BUT NOT PERFECT IN TERMS OF EXPECTED OUTCOME. IN TERMS OF A SPECIFIC RECOMMENDATION I THOUGHT IT WAS THOUGHTFUL AND HITS MANY THINGS ON THE NAIL THAT WE'VE TALKED ABOUT SEVERAL MONTHS. ONE THING THAT HIT ME ESPECIALLY WAS THE COMMENT THERE WAS A LACK OF TRUST IN THE SYSTEM BY MORE JUNIOR INVESTIGATORS. IT'S SOMEWHAT SHOCKING BECAUSE AS A JUNIOR INVESTIGATOR I DID NOT TRUST THE SYSTEM. I THINK WE ALL FEEL IT'S THE JEWEL OF EVERY OPERATION IN THE COUNTRY. THE QUESTION IS WHY. AND TO LOOK JUNIOR AND NEW INVESTIGATORS AN ADDED CONSIDERATION. CLEARLY, THAT'S NOT WORKED AT LEAST FROM THE PERCEPTION PERSPECTIVE FOR THE JUNIOR INVESTIGATOR AND OUR PERCEPTION IS TO SOME DEGREE REALITY. SO WHAT I THINK NEEDS TO BE DONE IS PERHAPS A CHANGE OR RETURN TO THE PAST BECAUSE I THINK OF WHAT WAS IT THAT WAS DIFFERENT FOR ME AS A JUNIOR INVESTIGATOR. MY VERY FIRST GRANT WAS AN R29 AND THAT WAS A GRANT FOCUSSED ON JUST NEW INVESTIGATORS. WE VIEWED THE COMPETITIVE FIELD AS I WAS JUST COMPETING WITH ANOTHER NEW INVESTIGATOR. THE REALITY DIDN'T MAKE MUCH OF AN IMPACT BUT THAT WASN'T THE POINT. THE PERCEPTION WAS I WAS COMPETING ON A LEVEL PLAYING FIELD THOUGH WHETHER THE COMMITTEE MADE A DIFFERENCE OR NOT. I DO THINK THERE IS SOMETHING TO BE SAID ABOUT THIS ASPECT WHERE WE HAVE MECHANISMS IN PLACE, PERHAPS, THAT ALLOW FOR THE TARGET GROUP OF INVESTIGATORS COULD BE COMPETING, STRUCTURALLY, AMONG THEMSELVES OR WITHIN A GROUP THAT'S WELL DEFINED. IT DOESN'T HAVE TO BE PAY LINE OR NUMBER OF GRANTS BUT THAT'S IMPORTANT. WHEN I THINK ABOUT TODAY AND WHAT I JUST HEARD VERSUS 5 YEARS AGO, THAT'S A STRUCTURAL DIFFERENCE IN TERMS OF PERCEPTION. >> GREAT POINTS, BRANDON. LINDA. >> SO AS A FOLLOW-ON TO THAT IS WHEN THE DATA'S NOT AVAILABLE IGNORANCE BREEDS FEAR. AS WE'VE HAD THE DISCUSSION SOME DATA WE'VE ASKED FOR MAY HELP YOUNG INVESTIGATORS. MAYBE THEY'RE GETTING SUPPORT AND DOING RO1s AND THE NUMBERS WE HAVE LOOK SCARY BUT THERE MAY BE MORE DIMENSIONS TO THIS AND WE APPRECIATE IT AND THAT MAY HELP BUILD SOME MORE TRUST IF THERE'S A MORE COMPLETE DATA SET ON WHAT'S GOING ON. I THINK WE HAVE PART OF IT BUT NOT THE WHOLE PICTURE. MAYBE IT IS REALLY AWFUL BUT MAYBE THERE ARE MITIGATING FACTORS WE JUST DON'T HAVE IN OUR SITES -- SIGHTS RIGHT NOW THAT WOULD HELP YOUNG INVESTIGATORS FEEL LIKE THERE'S MORE OUT THERE. I DON'T KNOW. WE NEED THE DATA. >> WHILE WE'RE ON THIS POINT BECAUSE I ALSO WAS SHAKEN UP AND TROUBLED BY THE STATEMENT ON THE SLIDE ABOUT LOSS OF TRUST, MY SENSE IS AND I'M GOING TO ASK AASK AMY IS UNDER THE FACE OF BLISTERING ATTACK WE HAD TO GET REVISED AND IT CAUSED EARLY-STAGE INVESTIGATORS TO FEEL NIH BA D -- ABANDONED OR STEP AWAY AND WHEN WE SAID WE'D FIND A WAY TO FIND FUNDS FOR THE E.S.I.s AND THE ABILITY TO DO SO LATE IN THE YEAR AND IN A FASHION THAT WOULD MEET ABOUT WHAT PEOPLE INTERPRETED AS AN ACROSS-THE-BOARD PERCENTILE DIDN'T HAPPEN AND THAT FURTHER ERODED A SENSE OF TRUST THAT NIH IS REALLY IN THEIR CORNER MAYBE I'M NOT ARTICULATING THE SENSE OF BEING DISILLUSIONED. >> I APOLOGIZE, I'M NOT WEARING A SUIT. I WENT TO SEE STAR WARS LAST NIGHT AND WENT TO BED LATE. SORRY. DR. COLLINS WHAT YOU POINT OUT IS CORRECT. THERE WAS WITH THE ROLLOUT OF THE GSI FOLLOWED BY THE NGRI, THE 25% WHICH WAS AN AVERAGE, THERE WAS THIS IDEA OR WE LEFT DISENFRANCHISED AND THE DECISIONS WEREN'T BEING MADE IN OUR BEST INTEREST AND I APPRECIATE WHAT DR. LEE SAID IN THAT WE DON'T FEEL IT'S A LEVEL PLAYING FIELD. THE DIVERSITY AND THE REPRESENTATION IS NOT EQUAL AND THEREFORE THE WAY PEER REVIEW IS HAPPENING NOW ACROSS IS ITS IS NOT REFLECTING TRUE MERIT DIVERSITY. IT'S NOT A LEVEL PLAYING FIELD SO TO HAVE A MORE EQUAL SYSTEM AND WE HOPE THIS WILL BE ABLE TO BE TAKEN FROM WHAT WE ARE SUGGESTING NOW INTO ACTIONABLE ITEMS WE HOPE TO PROVIDE YOU THROUGH THE WORKING GROUP AND FURTHER ON. >> THANKS FOR CLARIFYING THAT. LET ME SAY AS THE NIH DIRECTOR THAT REGAINING THAT SENSE OF CONFIDENCE IN THE NEXT GENERATION OF RESEARCHERS IS A HIGH PRIORITY TO US. YOU ARE THE FUTURE. WE ARE DOING OUR JOB PROPERLY WE SHOULD BE ENCOURAGING YOUR VISION, YOUR DREAMS, YOUR CAPABILITIES TO DO ALL THE THINGS THAT WE WANT YOU TO DO. >> PAM KRIEGER IS ON THE LINE AND WANTS TO ADD. PAM, ARE YOU THERE? ARE YOU ON MUTE? >> LARRY, ON THE PRODUCTIVITY ASSESSMENTS, CAN YOU EXPLAIN MORE AND I HAVE A COMMENT -- >> HI, SORRY. >> PAM, IS THAT YOU? >> YES, I'M SO SORRY. I ACCIDENTALLY HUNG UP INSTEAD OF UNMUTING MY PHONE. >> ROY, IS IT OKAY? PAM, MAKE YOUR COMMENT, PLEASE. >> I WANTED TO FOLLOW-UP ON THE COMMENT ON TRUST AS WELL. I THINK A BIG PART OF IT WAS WITH THE GSI AND RESPONSE. THERE STILL A DEEPER UNDERLYING LACK OF TRUST IN PIER REVIEW. MY EXPERIENCE FROM COLLEAGUES OF SIMILAR CAREER LEVELS IT'S NOT UNCOMMON TO HEAR, WELL, THE GRANT HAS MAJOR FLAWS BUT IF ANYBODY CAN DO IT, THEY CAN DO IT. LOOK AT HOW PRODUCTIVE THEY'VE BEEN. THEY HAVE THREE RO1s ALREADY. IN ADDITION TO ALL THE KNOWN STUDIES ABOUT THE PROBLEMS WITH IMPLICIT BIAS FOR WOMEN AND UNDER REPRESENTED MINORITIES IS A BIGGER PROBLEM BECAUSE IT'S ALL BASED ON WHERE YOU SCORE IN PEER REVIEW. SO PEER REVIEW HAS FLAWS THEN WE'RE JUST PUTTING A BAND-AID ON A BIG PROBLEM INSTEAD OF SOLVING THE PROBLEM. >> I HEARD SIMILAR CONCERNS AND I THINK THERE ARE SOME THINGS WE ARE LOOKING AT TO TRY AND SEE HOW TO ADDRESS THAT. WE HAVE MET THE ENEMY IN THIS CASE AND IT IS US. ALL OF US WHO ARE APPLYING FOR PEER REVIEW ARE THE ONES DOING PEER REVIEW. [TECHNICAL DIFFICULTIES] >> THERE WAS A SENSE OF THE GROUP AND JOSƒ, PLEASE JUMP IN, THERE WAS A SENSE OF THE GROUP THAT JUST DOING A BIBLIOMETRIC ANALYSES WOULD FALL SHORT AND A PERSON TO KNOW WHAT THEY'RE ACCOMPLISHING MOST IS THE APPLICANT SO MAYBE WE NEED A PORTION OF THE BIOSKETCH WHERE THAT COULD BE ARTICULATED. JOSƒ. >> IF WE'RE COMING TO THE CONCLUSION THAT WE NEED TO SHOW WHERE THE FUNDS WILL COME FROM BECAUSE THAT'S WHAT WAS LEFT HANGING IN JUNE AND THE DATA SHOWED IF WE DON'T DO THAT, SIMPLY MOVING THE PAY LINE WILL BE A WASH AND NOT PROTECT THE PEOPLE WE'RE INTENDED TO PROTECT SO WE'LL PROVIDE THAT AS ONE ASSUMPTION. SECOND, IF PRODUCTIVITY IS GOING TO BE A METRIC TO BE USED IN THE SENIOR INVESTIGATORS TO GAUGE WHETHER THEY CAN TAKE ANOTHER GRANT OR NOT, THEN SIMPLY HAVING A BIBLIOMETRIC ASSESSMENT LINKED TO THE GRANTS THEY HAVE MAY BE INSUFFICIENT AND THEY MAY TARGET MORE UNDER REPRESENTED POPULATIONS AND MINORITY ARE MORE LIKELY TO PARTICIPATE BECAUSE THERE'S A DESIRE TO HAVE DIVERSE REPRESENTATIVE COMMITTEES AND WHEN IT COMES TO MENTORING BECAUSE SOME WANT TO DEVOTE TO MENTORING OR COMMUNITY SERVICES, THEY MAY BE LESS ABLE TO WRITE THE PAPERS AND GIVE A GOOD ASSESS MANY BUT THEY ARE CLEARLY PRODUCTIVE TO THEIR ENTERPRISE AND FANTASTIC CITIZENS AND THE BEST WAY TO GAUGE PRODUCTIVITY MAY BE TO LET THEM TELL THEIR OWN STORY AND SAY WELL, THERE'S PRODUCTIVITY HERE THAT IS RECOGNIZED AND WHETHER IT'S THE LEVEL OF STUDY OR CONSULT IS TO BE DECIDED. >> NOW MY COMMENT, I THOUGHT THAT'S WHERE YOU WERE GOING. I THINK THAT'S OPPOSITE OF WHAT THE INDUSTRY IS GOING TO AND BECOMING LESS PRODUCTIVITY CENTRIC. AND PARTICULARLY IN HIGHER EDUCATION WE HAVE SOMETHING CALLED TENURE NOW AND PRODUCTIVITY IS BEING MEASURES IN MANY WAYS AND THE ISSUE IS NOT SO MUCH WHETHER THEY SHOULD BE USED BUT MORE WHAT THE VALIDITY OF THE MEASURE IS. SO THE FOCUS, I THINK, SHOULD BE ON VALIDATING PRODUCTIVITY MEASURES BUT USING I SO THAT YOU CAN REALLY GET TO AS JOSƒ SAID, GET TO UNDERSTAND THE FULL OF WHAT PEOPLE ARE DOING. >> AND FROM YOUR PERSPECTIVE AS THE PRESIDENT OF A UNIVERSITY AND SO FORTH, THAT'S VERY HELPFUL. YOU SUMMARIZE THE DISCUSSION THE GROUP HAD. WHAT I PRESENTED WAS NOT A CONSENSUS. IT WAS TO PROVIDE A RANGE OF DISCUSSION. WE CLEARLY HAVE MORE WORK TO DO IN THIS. >> IT SEEMS LIKE CITIZENSHIP IS A BETTER TERM FOR THE KIND OF CONTENT YOU'RE NOT NECESSARILY GETTING NOW IN TERMS OF OTHER CONTRIBUTIONS PEOPLE MAKE THAT COULD BE VALUED AS YOU JUDGE GRANTS. >> THE REASON WE'RE DOING THIS IS BECAUSE CONGRESS GOT IT RIGHT. WE HAVE TO DO THIS FOR BIOMEDICAL RESEARCH TO FLOURISH. WE HAVE WORKING FROM WHAT WAS DONE IN THE '60s AND '70s AND NOW WE'RE IN A DIFFERENT PLACE AND POSSIBLY THE BEST TRAINED SCIENTIFIC WORKFORCE TO CONTRIBUTE AND THEY NEED THEIR CHANCE LIKE WE HAD OURS. AS PAINFUL AS THE CONVERSATION IS WE HAVE TO DO IT AND WE HAVE TO MAKE CHANGES. I'LL LEAVE IT AT THAT. >> CAN I ASK LARRY, JOSƒ, WHENEVER WANTS TO ADD TO THIS THE NOT HAVING THE HARD AND FAST DEFINITION OF E.S.I. SEEMED RATHER UNFAIR IF YOU'RE OPPORTUNITY TO APPLY HAPPENED TO OCCUR ONE MONTH AFTER THE 10-YEAR PERIOD YOU'RE MISSING OUT ON THIS KIND OF PLACE THAT YOU WOULD REALLY WANT TO HAVE BE THAT'S COMING IN FOR THE FIRST TIME. AT NIH WE'VE HAD THIS SEPARATE CATEGORY CALLED NEW INVESTIGATORS. THAT HAVE PEOPLE WHO HAVE NOT PREVIOUSLY APPLIED AND BEEN SUCCESSFUL AS AN NIH APPLICANT. YOU SAY WHY DON'T WE GO WITH THAT AND SOME HAVE BEEN FUNDED BY OTHER SOURCES. MAYBE THEY WERE FUNDED BY NSF OR DOD AND COMING TO THIS SOURCE OF FUNDING FOR THE FIRST TIME. WE HAVE TO MAKE SURE THERE'S A DIFFERENT KIND OF ISSUE. IF THE GROUP AND WHAT ALTERNATIVES COULD YOU CONSIDER IN TERMS OF SOMETHING THAT WOULDN'T END UP BEING SO SQUISHY. >> THERE'S THE AVAILABILITY OF AN INDIVIDUAL BEING AT RISK WE WANT TO BE ABLE TO GIVE THAT INDIVIDUAL THE OPPORTUNITY. AND THERE'S MEANS OF SUPPORT AND WE COULD ENJOY THE OTHER STREAMS OF SUPPORT. IT COULD BE AN ARBITRARY DEFINITION. >> THE KINDS OF CRITERIA RAISED AT THE MEETING AND WOULD TAKE YOU BEYOND THE 10 YEARS WERE THINGS LIKE DIFFICULTY WITH FAMILY SITUATIONS OR EMERGENCY OR MATERNITY LEAVE OR A REASON TO GIVE AN EXTRA YEAR. ANY WOMAN COULD HAVE AN EXTRA YEAR AND THINGS WERE THAT AS POTENTIALLY MITIGATING FACTORS. YOU COULD SAY WE COULD SPEND ALL OUR TIME TRYING TO PARSE WHETHER THEY'RE REAL OR NOT. IT WON'T BE A HUGE NUMBER OF PEOPLE IN THIS CATEGORY AND WOULD PROBABLY BE FEASIBLE TO LOOK AT THE INDIVIDUAL SITUATION. THOSE KINDS OF THINGS WERE BROUGHT UP. >> AS LARRY SAID AND OTHERS, THE GOAL HERE IS NOT ONLY TO PROTECT YOUNG PEOPLE, IT'S TO SLOW DOWN OR SOMEHOW REVERT THE ATTRITION IN THE WORKFORCE OF PRODUCTIVE MERITORIOUS INVESTIGATORS PARTICULARLY IN THE MID YEAR RANGE AND THOSE ACROSS THE SPECTRUM IN DANGER OF LEAVING SCIENCE OR ACADEMIA BECAUSE OF HOW COMPET IG -- COMPETITION IS STRUCTURED AND THE INSTITUTION THAT SUPPORTS YOU AND THERE'S MANY THINGS BUT IF YOU'RE AT RISK, YOU'RE A GOOD SCIENTIST AND GIVING GOOD SCIENCE AND AT RISK IN THE NEAR OR MEDIUM TERM OF LEADING SCIENCE BECAUSE HAVE YOU NO SUPPORT NOT JUST FROM NIH WE NEED TO DO SOMETHING. FROM WE NEED TO THINK BROADLY IN TERMS OF DEFINING WHAT THIS IS. >> INTRODUCE YOURSELF. >> I'M THE DIRECTOR OF THE DIVISION OF BIOMEDICAL RESEARCH WORKFORCE AND THE TASK LEAD ON THE NEXT GENERATION ACADEMY INITIATIVE. IN THAT CONTEXT WE ACTUALLY COLLECTED A LOT OF DATA ON INVESTIGATORS AND ESTABLISHED INVESTIGATORS. PART OF THIS WAS DRIVEN BY THE CONCERN THAT SOME OF THE NEW INVESTIGATORS WERE NOT EARLY STAGE INVESTIGATORS. I THINK A COUPLE IMPORTANT POINTS TO NOTE IS THAT THERE ARE MORE OLDER NEW INVESTIGATORS BUT THIS STILL IS A SIGNIFICANT NUMBER OF THEM STILL RELATIVELY EARLY IN THEIR CAREER. THE SECOND IS THAT WE HAVE STATISTICAL EVIDENCE THAT WOMEN AND UNDER REPRESENTED MINORITIES ARE ACTUALLY A HIGHER PROPORTION OF THE APPLICANT AND AWARDEES IN THE NEW INVESTIGATOR POOL AS WELL AS IN THE EARLY STAGE INVESTIGATOR POOL. AND ON THE GROUND I HEAR FROM WOMEN WHO HAVE PUT IN MULTIPLE GRANTS WHO HAVE MERITORIOUS SCORES AND STILL HAVE NOT ACHIEVED THE RO1 AND LOST THEIR E.S.I. STATUS TWO YEARS AGO. I THINK THERE SHOULD BE THE PREROGATIVE TO LOOK AT NEW INVESTIGATORS AS WELL IN THE CONTEXT WE'RE LOOKING TO FUND THOSE PASSIONATE ABOUT SCIENCE AND STAY IN BUT HAVE NOT MANAGED TO GET IN THERE. AND IT AFFECT THE DIVERSITY ISSUE AS WELL. >> I'M NED SHARPLESS THE NEW NCI DIRECTOR. AS I'VE COME MONTHS AGO I'VE CAREFULLY LOOKED AT THE ISSUE THE POINT OF REFERENCE THE SUCCESS RATE COULD BE MORE THAN DOUBLE TO THE RATE. WE'VE DONE OUR OWN ANALYSES ON WHAT THE IMPLICATIONS COULD HAVE ON INVESTIGATORS. TWO THINGS THAT SURPRISED ME IS WE PERFORMED AN ANALYSIS ON YEARS SINCE DEGREE. THE DEFINITION OF E.S.I. AND WE WERE SURPRISED TO SEE THE 10-YEAR NUMBER IN THE NCI DIDN'T APPEAR TO MAKE SENSE. IT'S EXACTLY BY SEX, A HISTOGRAM IN WHERE YOUR INVESTIGATORS FALL. THAT NUMBER MAY HAVE MADE SENSE YEARS AGO WHEN THE RO1 AGE WAS EARLIER BUT AS THE AGE HAS INCREASED, IF YOU WANTED TO HAVE A TEMPORAL NUMBER AND LARRY SAID IT'S MAYBE NOT A GOOD IDEA BUT YOU HAVE TO GET PAST THE MIND SET OF 15 YEARS LATER YOU'RE AN EARLY STAGE INVESTIGATOR. SEE, THAT WOULD BE THE METRIC-DRIVEN DECISION AT NCI. SECOND IS WE TALKED ABOUT WHAT WOULD BE THE IMPACT OF PRIORITIZING INVESTIGATORS THAT DON'T HAVE FUNDING OR ON THE VERGE OF LOSING FUNDING. AND I THINK IF YOU APPLY THAT TO YOUNG INVESTIGATORS 15 YEARS IN THEIR CAREER AND THAT'S A REALLY GOOD IDEA AND SOMETHING WE DEFEND, BUT IF YOU TAKE THAT TO THE LOGICAL EXTREME AND SAY ANYBODY ABOUT TO GET FUNDING GETS A SPECIAL PAY LINE YOU GET A SYSTEM YOU HAVE TWO PAY LINES FOR FUNDED AND UNFUNDED INVESTIGATORS AND I DON'T THINK THAT'S A GOOD IDEA. AND I THINK ANY UNIVERSITY PRESIDENT OR DEPEND -- INVESTIGATORS WILL TELL YOU IT'S NOT ONLY A BAD USE OF THE NIH FUNDS BUT THE INSTITUTIONAL COMMITMENT REMAINS STRONGER. IT'S IMPORTANT TO ACKNOWLEDGE. >> IT SEEMS WE HAVE TWO THINGS WE'RE TRYING TO SOLVE FOR. ONE IS TO MAXIMIZE PRODUCTIVITY AND ONE TO SUSTAINABILITY. WE CAN DO A GREAT JOB OF MAXIMIZING PRODUCTIVITY IF WE JUST GAVE IT TO THE MOST SENIOR INVESTIGATORS DOING THE SAFEST SCIENCE BUT THAT WOULDN'T GIVE MUCH OF A FUTURE. WE NEED TO ENSURE WE'RE SUSTAINING THE PIPELINE AND THAT REQUIRES WE INVEST IN YOUNG INVESTIGATORS. I THINK ONE OF THE MAJOR PROBLEMS WE HAVE IS THE AGE OF FIRST AWARD. THEY'RE OFTEN GETTING IT 10 YEARS INTO THEIR CAREER. THE OTHER ACCESS AND I'M CONCERNED ABOUT THE DESIRE TO KEEP PEOPLE IN THE SYSTEM AT PERHAPS ALL COSTS. I DON'T THINK THAT MAXIMIZING THE NUMBER OF INVESTIGATORS IS A WISE ELEMENT TO BE SOLVING FOR. I'LL COME BACK TO ONE OF THE ISSUES FRANCIS HAS RAISED ON A NUMBER OF OCCASIONS. THERE'S THE INSTITUTIONAL COMMITMENT TO INVESTIGATORS. IT'S UNCLEAR TO ME WHY NIH SHOULD BE MORE COMMITTED TO KEEPING PEOPLE IN THE GAME WHEN THEIR INSTITUTIONS ARE NOT PROVIDING SUPPORT THAT WOULD ALLOW THAT. >> THANK YOU. THOSE WERE THOUGHT PROVOKING INDEED. >> I'M A FELLOW AT NIH AND SERVE ON THE WORKING GROUP WHICH HAS BEEN A SUPER EXPERIENCE. THE TWO THINGS I WANT TO BRING UP WE HAVEN'T HEARD MUCH ABOUT IS THE COMMITMENT TO INNOVATION, LARRY MENTIONED IN THE PRESENTATION. THERE ARE MECHANISMS IN PLACE FOR BUILDING INNOVATION IN YOUNG INVESTIGATORS, NOT AT THE MID CAREER. SO AT THE MID CAREER STAGE, YOU ARE OFTEN HURT MORE THAN HELPED IN INNOVATIVE THINGS AND YOU'RE HAVING LESS PRODUCIVITY WHEN YOU'RE DOING MORE AND THERE'S MORE MECHANISMS AT THE EARLY STAGE. I'M AN INNOVATOR THAT MAKES ME NERVOUS FOR HOW I'LL KEEP FUNDING ALL THE MICRO SCOPES I WANT TO BUILD AND THE OTHER IS RESOURCE SCARCITY. AND OPPORTUNITIES TRAIN GRANTS FOR TRAINEES. THESE ARE THINGS WE SHOULD EVALUATE WHEN WE LOOK AT METRICS OF PRODUCTIVITY AND WHO IS AT RISK. >> I WANT TO ADDRESS THE SECOND COMMENT NED MADE AND RICK FOLLOWED WITH. ARE WE GOING TO UNFUND PEOPLE AND IS THE END POINT. THAT WOULD BE A VALID CONCERN AND I THINK IN AN ERA WHEN WE HAVE 10% TO 12% OF GRANTS THERE'S EVIDENCE THAT SHOWS WE ARE NOT THAT GREAT PREDICTING THE SCORES AND THIS THINGS ARE GOING INTO THE ASSESSMENT. WHAT WE'RE TRYING TO DO IS MAKE SURE THE PEOPLE WHO JUST MISSED THE PAY LINE AND THEY GO ONES AND THREES AND IT'S ABOUT THE CAPACITY OF THE SYSTEM AND MAKING SURE AND WITH THE DOUBLING OF THE BUDGET WE'RE ATTRACTING PEOPLE. AND THE SECOND POINT IS IT'S THE CHICKEN OR THE EGG AS FAR AS INSTITUTIONAL SUPPORT. IT'S TRUE THE INSTITUTIONAL COMMITMENT TO A PERSON WILL OFTEN BE PREDICATED AND SOMEONE WE WANT TO PROTECT BECAUSE THEY BRING A LOT IN TERMS OF INSTITUTIONAL SERVICE AND MENTORSHIP AND EVERYTHING ELSE, MAYBE WE ARE ELICITING A RESPONSE TO SUPPORT THAT PERSON. THERE'S A ROLE NIH CAN PLAY THROUGH INCENTIVES TO PROTECT THE WORKFORCE. IT'S DOES NOT LEAD TO THE FUNDING OF SCIENCE THAT IS MARGINAL. >> I'D LIKE TO FOLLOW-UP ON THAT. THE REASON THESE INDIVIDUALS ARE THOUGHT TO BE AT RISK IS BECAUSE THERE'S NOT SUFFICIENT SUPPORT FOR SALARY UNLESS THEY HAVE A SUFFICIENT PORTFOLIO. WE HAVE CREATED PERVERSE INCENTIVES FOR INSTITUTION TO HIRE PEOPLE WITHOUT OBVIOUS MEANS OF SUPPORT OUTSIDE THE NIH FUNDING. I'M NOT SURE NIH HAS DONE THESE PEOPLE A DISSERVICE WITH THEIR HOST INSTITUTIONS. >> RICK, I DID WANT TO COME BACK THOUGH TO ONE THING YOU SAID, YOU SAID THE BEST WAY TO GET IN THE SHORT-TERM PRODUCTIVITY IS TO GIVE IT TO WELL FUNDED, EXPERIENCE THE INVESTIGATORS. I THING WE KNOW THAT'S NOT RIGHT. WHEN YOU LOOK AT THAT AS WHATEVER MEASURE OF PRODUCTIVITY YOU WANT TO PICK AND WE CAN ARGUE WITH WHAT'S PERFECT BUT THERE IS A LAW OF DIMINISHING RETURNS WHEN AN INVESTIGATOR'S LEVEL OF FUNDING IS IN THE HIGHEST CATEGORY AND I DIDN'T WANT THAT TO HANG OUT WITHOUT BEING CHALLENGED BECAUSE I THINK WE HAVE THAT AND WHILE THAT IS TRUE IN THE AGGREGATE AND I'M CONVINCED OF THE DATA AND THE AGGREGATE IT'S A BIG LEAP TO GO THERE TO SAYING FOR A SPECIFIC INVESTIGATOR THAT MEANS THEY SHOULDN'T GET THE FOURTH GRANT BECAUSE IN GENERAL IT HASN'T TURNED OUT SO WELL FOR THAT INVESTIGATOR THAT MAY BE JUST THE RIGHT THING TO DO FOR THE NEXT BREAKTHROUGH AND THAT'S WHERE WE HAD TO STEP AWAY FROM GSI AND HAD TO SUPPORT THE NEED TO DO SO. BECAUSE WE'RE AFTER ALL AN INSTITUTION THAT VALUES INDIVIDUAL PROMISE AND CREATIVITY AND IT SEEMED FORMULA- DRIVEN THAN OPPOSED TO WHAT IT SHOULD HAVE BEEN AND I WANTED TO PUT THAT FRAME AROUND IT SO MAKE SURE WE DON'T WALK PAST IT. >> I DON'T DISAGREE WITH THAT AT ALL. I WAS THINKING MORE ALONG THE LINES OF WHEN I WAS A BRAND NEW INVESTIGATOR WITH NO ONE IN MY LABORATORY, IT'S GOING TO TAKE THAT A WHILE TO GET UP AND RUNNING TO BE PRODUCTIVE WITH SUFFICIENT PEOPLE ALREADY WELL TRAINED. I WAS THINKING ABOUT THIS FROM THE CONTEXT OF, FOR EXAMPLE, PHARMA. PHARMA IN THE SHORT TERM CAN PUT THEIR CLINICAL DEVELOPMENT IN A PIPELINE BUT IF THEY HAD NOTHING IN EARLY DISCOVERY, 10 YEARS DOWN THE ROAD THEY WOULDN'T HAVE NOTHING TO WORK ON AND WE'RE IN THE SAME SITUATION. WE NEED TO MAXIMIZE OUR PRODUCTIVITY WHILE ENSURING WE HAVE A SUSTAINABLE PIPELINE OF OUTSTANDING INVESTIGATORS. >> THOSE ARE ALL GOOD POINTS. IF YOU HAD A GRANT UNDER REVIEW I THINK IT WOULD HAVE TURNED OUT WELL. >> THE FIRST NIH APPLICATION RECEIVED A SCORE OF FIVE. >> SO I'M JUST DELIGHTED WE'RE HAVING THIS CONVERSATION IT'S WONDERFUL TO HEAR THE COMMENTS. THERE'S TWO OBSERVATIONS I WANT TO PUT ON THE TABLE. THE FIRST IS OUR UNHEALTHY OBSESSION WITH THE R01 GRANT. THAT MAY BE MORE OF AN INSTITUTIONAL ISSUE WE JUST STOP MOVING AWAY FROM THE RO1 TO BE ANY OUTSTANDING SCIENTIST. IN THE 21st SEARCH -- CENTURY THAT'S NOT TRUE ANYMORE AND IT'S GOOD FOR AN ENTERPRISE -- IMAGINE YOUR OWN PORTFOLIO, TO HAVE 10% OF THE INDIVIDUALS CONTROLLING 40% OF THE FUNDING. IS THAT THE BEST MODEL? I DON'T KNOW WHAT ECONOMISTS WOULD TELL US AND WHEN I THINK OF PRODUCEABILITY AND YOU HAVE A HOST OF INDIVIDUALS AND NOW THE RESEARCH ENTERPRISE HAS THE ERROR IN IT. IT WOULD BE SYSTEMIC ERROR RATHER THAN RANDOM ERROR BUT STILL THERE IS THAT POINT. >> GOING BACK TO THE POINT OF LEVEL PLAYING FIELDS AND TO HIGHLIGHT THE NEW INNOVATORS PROGRAM THAT DOES A GOOD JOB OF EXECUTING ON THAT FROM MY POINT OF VIEW I SEE AN IMPACT IN GETTING PEOPLE IN THE SYSTEM AND WHEN YOU START OUT WITH AN EMPTY LAB, I DON'T KNOW -- I IMAGINE THE PEER REVIEW IS DIFFERENT THAN RO1s AND IS THAT MORE ON THAT AS FAR AS MERITORIOUS APPLICATIONS. IT CHECKS SOME OF THE BOXES. WE'VE JUST GOT AN OUTCOME EVALUATION OF THE FIRST FOUR YEARS OF PROGRAM YOU CAN FIND ON THE WEB. IT'S DATA DRIVEN AND SUPPLEMENTED WITH EXPERT OPINION, REVIEWS OF THE OUTCOMES FROM THE FUNDING, INTERVIEWS WITH THE PEOPLE WHO RECEIVED FUNDING AS A CONTROL GROUP OF EARLY STAGE RO1s VERSUS NEW INNOVATORS. THE FIRST QUESTION IS CAN WE PRODUCE MORE INNOVATION AND IMPACT WITH THE FREEDOM OF TIS TYPE OF WARD AND THE ANSWER'S CLEARLY YES. THE SECOND QUESTION IS ARE WE HURTING PEOPLE'S CAREERS BY FOSTERING THE INNOVATION AND THE ANSWER IS NO. I THINK THERE'S A VERY LARGE POOL OF PEOPLE WHO CAN HANDLE AN INNOVATION -- A RISK-TOLERANT A. AND I'M A PROPONENT OF EXPANDING THIS TO THE INSTITUTES BECAUSE CURRENTLY IT'S A FUNDED PROGRAM. THE POOL OF THE FOLKS ARE DEEP. >> ARE THERE OTHER MEMBERS OF THE WORKING GROUP ON THE LINE THAT WOULD LIKE IT MAKE COMMENTS? THIS IS NOT A BASHFUL GROUP. MAYBE THE TIME DOESN'T WORK FOR PEOPLE. THEY WERE ALL AT THE STAR WARS MOVIE LAST NIGHT. OKAY. JOSƒ. >> JUST A COUPLE QUICK THINGS TO MENTION ON THE POINT ON THE RO1 OBSESSION, I AGREE WE DON'T WANT TO INCENTIVIZE INSTITUTION IT'S THE SOUL MEASURE OF SUCCESS. AND WE NEED TO LOOK AT METRICS AND THINGS SO IT'S ONE PLACE TO START THAT AT LEAST MAKES IT EASIER TO STUDY BUT I AGREE WE DON'T NEED TO SAY IT'S THE ONLY MECHANISM AND SO WE DON'T THINK WE CAN MANDATE NIH SERVICE BUT WE CAN INCENTIVIZE IT. IF IT LOOKS TO APPLY FOR A FOURTH GRANT IT INCENTIVIZES OR SHEPHERD THE APPROACH. >> INTERESTINGLY, BARBARA LEFT THE ROOM -- >> IN THE NICK OF TIME. >> THERE ARE THINGS WE CAN DO BUT CERTAINLY THE SENTIMENT IS ONE WE NEED TO COME BACK TO. >> IF YOU RECEIVE THE AWARD AND ASKED TO SERVE IN PEER REVIEW IT'S EXPECTED THE ANSWER WILL BE YES. >> IN THE TERMS AND CONDITIONS OF THE GRANT WORK, DO I HAVE THAT RIGHT? >> >> THE NIH DOES EXPECT THAT. THE NIH HAS A DID MECHANISM FOR THE NEW CONTEXT OF DOLLAR AMOUNT OR TYPE OF GRANT. IT'S THE RO1. I SUPPORT THE IDEA OF REALLY GOING AWAY FROM BEING FOLKED -- FOCUSSED ON THE FIRST INTRAMURAL FUNDING MAY LEAD TO A CHANGE OF DOLLAR AMOUNTS. THAT'S A FAIR WAY THAT'S BEEN AN INVESTMENT IN YOUR RESOURCE PROGRAM WHETHER IT'S FROM SOME SOURCE, DOD OR WHAT HAVE YOU. I THINK THAT'S A FAIR METRIC FROM MY PERSPECTIVE WHETHER YOU'RE FIVE, TEN OR FIFTEEN YEARS OUT. >> WELL, THIS HAS BEEN A VERY USEFUL DISCUSSION WITH LOTS OF GOOD POINTS I KNOW THE WORKING GROUP CAN BRING ON BOARD AND THERE'S NOT A TOPIC MORE CRITICAL TO GET RIGHT THAN THIS ONE. I KNOW WE'VE HAD BUMPED IN THE ROAD OVER THE COURSE OF THE LAST YEAR AND I WANT TO BE TOTALLY TRANSPARENT ABOUT THAT AND TO COMMIT ONCE AGAIN TO TRY TO MOVE THIS IN A DIRECTION THAT HAS THE MAXIMUM OUTPUT FOR THE NEXT GENERATION WE'RE COUNTING ON TO BE FUTURE LEADERS AND GET THEM THERE AS QUICKLY AS POSSIBLE. SO THANK YOU, LARRY, AND THANK YOU, JOSƒ. AND THANK YOU TO THOSE ON THE WORKING GROUP WHO ARE HERE AS PART OF THIS AND SPECIAL THANKS TO AMY AND JUAN PABLO HERE IN PERSON AND MEMBERS ON THE PHONE AND MEMBERS OF THE ACD ALSO ON THE GROUP. I SUSPECT YOU'LL BE PRETTY BUSY IN THE NEXT COUPLE MONTHS TO BRING TO US IN JUNE SOME SPECIFIC RECOMMENDATIONS BUT I THINK IT'S VERY WISE NOT TO DO THAT PREMATURELY BECAUSE MAYBE WE GOT AHEAD OF OURSELVES AND WE WANT TO THOUGHTFULLY COME THROUGH WITH A SET OF RECOMMENDATIONS WE WILL HAVE CONSIDERED THE UNINTENDED CONSEQUENCES WE HAVE ARTICULATED WE NEED TO WORRY ABOUT AND THEN WE CAN MOVE FORWARD TOGETHER. AGAIN, I THINK ALL THE INSTITUTE AND SENATE DIRECTORS ARE WATCHING CLOSELY AND TO DO WHAT THEY CAN TO PROVIDE THE RIGHT SUPPORT SYSTEMS HERE AND WE WILL DO THIS TOGETHER AND WE'LL DO IT ACCORDING TO THE BEST ADVICE AND I'M COUNTING ON THE WORKING GROUP TO BRING THAT FORWARD AND LOOKING FORWARD TO SEEING WHAT THAT LOOKS LIKE. SO WITH THAT I THINK WE CAN MAYBE TAKE A QUICK BREAK. SEVEN MINUTES? THEN COME BACK ROUGHLY AT 10:45 TO LISTEN TO NORA VOLKOW'S PRESENTATION ABOUT OPIOIDS. >> NORA VOLKOW AS THE DIRECTOR OF NATIONAL INSTITUTE OF DRUG ABUSE IS OUR LEAD IN BOTH HER SCIENTIFIC EXPERTISE AND SKILL IN MANAGING THE ENTERPRISE AND INTERACTING WITH LOTS OF OTHER PARTS OF THE GOVERNMENT AND WITH AGENCIES OUTSIDE THE GOVERNMENT TO TRY TO SEE WHAT WE CAN DO. LET ME JUST SAY NORA AND I HAVE SPENT A LOT OF TIME ON THE ISSUE OVER THE COURSE OF THE LAST NINE MONTHS OR SO AND IT'S ONLY ENHANCED MY ADMIRATION FOR HER SKILL, LEADERSHIP AND SCIENTIFIC KNOWLEDGE. I THINK IT WOULD BE A REAL TREAT TO HAVE HER COME AND SPEAK SO WE ASKED HER TO DO SO AND SHE'S PREPARED TO WALK YOU THROUGH WHATEVER IT IS THAT SHE THINKS WOULD MAKE THE MOST USEFUL PRESENTATION. THE FLOOR IS YOURS. >> THANK YOU, FRANCIS AND FOR GIVING THE ME OPPORTUNITY TO SPEAK WITH ALL OF YOU. AS FRANCIS HAS CLEARLY STATED THIS IS THE MAIN CRISIS WE'RE FACING AS A NATION. IT'S ALSO VERY DISTURBING IS THAT WE DON'T SEEM TO CONTROL IT AND WE'RE SEEING THE FATALITIES GOING UP 22% AND THAT IS WHAT IS SO FRUSTRATION AND IT'S BEEN A PLEASURE EARLY LITERALLY THE PASSION FRANCIS HAS THROWN HIMSELF INTO THE CRISIS BECAUSE IT'S A CRISIS THAT REQUIRES THE INTERVENTION OF MULTIPLE GROUPS AND WE HAVE BEEN STATING THIS IS AN ALL-DECK APPROACH, IT'S NOT JUST THE TERM EVERYONE USES BUT WE NEED TO WORK TOGETHER AND WORK TOGETHER AS A PRIORITY AND BE AS CREATIVE AS WE CAN. WE NEED TO STOP IT. SO I PRESENTED IN JUNE IN 2017 AND I GAVE YOU A PERSPECTIVE AND FRANCIS GAVE YOU AN IDEA OF SOME OF THE THINGS WE'RE DOING AFTER LISTENING TO FRANCIS I SAID LARRY, I'M GOING CHANGE MY SLIDES. HE SAID OKAY SO I CAN FOCUS VERY MUCH ON THE HIGHLIGHTS OF WHAT HAS HAPPENED SINCE I LAST MET WITH YOU. SINCE I ONLY HAVE 15 MINUTES AND WE WANT TIME FOR DISCUSSION, I HAD TO SELECT, I THINK, SOME OF THE MORE SALIENT ISSUES THAT INTEGRATE THE OTHER ACTIVITIES. THAT'S WHAT I'M GOING TO DO TODAY. AND THE I'LL SHOW YOU THE SLIDE AND SPEAKS TO THE URGENCY OF WHERE WE ARE. UNFORTUNATELY I SHOWED THE SLIDE IN JUNE, 2017. WE ARE ON DECEMBER 2017 AND I HAVE NOT BEEN ABLE TO CHANGE THE SLIDE TO SHOW 2016. IT SAID WE'LL HAVE RED SPOTS WHICH ARE THE AREAS WITH THE HIGHEST OF FATALITIES AND MANY WILL BE OCCUPYING THE AREAS OF THE COUNTRY AND STATES WHERE THEY'RE SEEING THE STEEPEST INCREASE INCLUDING MARYLAND. THAT ACTUALLY IMPORTANT BECAUSE IT DOES REFLECT THE CHANGING NATURE OF THE EPIDEMIC WE NEED TO ADDRESS. AND THIS IS ACTUALLY THE DATA THAT INDICATES WHY THE SHIFTING NATURE OF THE EPIDEMIC. THIS IS PARTICULAR DATA. NOT THE OFFICIAL CDC DATA. THAT'S WHERE THE ESTIMATED 22% INCREASE IN EVERY DOSE FATALITIES. TO THE RIGHT YOU'LL SEE PRESCRIPTION OPIOIDS ARE STILL SLIGHTLY GOING UP BUT YOU CAN SEE 15,400 DEATHS FROM HEROIN AND THOSE ARE RISING STEEPLY STARTING 2010. YOU SEE THE BEFORE YOU ONES HERE AND 20,000 FATALITIES AND THAT'S A RECENT PHENOMENON AND THIS IS WHAT WE'RE FACING. WE HAVE A PRESCRIPTION OPIOID EPIDEMIC FACILITATING THE ENTRY TO HEROIN AND AS PEOPLE BECAME ADDICTED TO HEROIN AND BECAME TOLERANT AND THE BLACK MARKET REALIZED THEY CAN SYNTHESIZE THE DRUG AND THE STRONG EFFICACY HAS LED TO THE LACING OF HEROIN INITIALLY TO THE LACING OF FENTANYL AND SEEKING FENTANYL AND BECOMING ADDICTED SO I PRESENTED THE SLIDE LAST TIME AND THIS IS THE STRATEGY WE'RE FOLLOWING IN THE WHOLE NIH INITIATIVE BECAUSE I WANT TO REITERATE THIS IS NOT ONE INSTITUTE PROBLEM, THIS IS BASICALLY A WHOLE NIH ISSUE. AND WE HAVE TO REALIZE THE PRESCRIPTION EPIDEMIC STARTED WITH OPIOIDS AND IF YOU LOOK AT THE DATA AND THIS IS DATA AS OF NOW HAS NOT BEEN PUBLISHED BUT WILL BE IN THE AMERICAN JOURNAL AND WHEN WE DO THE ANALYSIS IN THE EMERGENCY DEPARTMENT OF THE PEOPLE WHO OVERDOSE, WHAT WAS THE NATURE OF THOSE OVERDOSES BETWEEN THE TIME IS 60% OF PATIENT OVERDOSING WERE THOSE THAT RECEIVED A DIAGNOSIS OF A CHRONIC PAIN CONDITION AND WE HAVE TO BE BETTER TO MANAGE PAIN SAFELY AND EFFECTIVELY AND WE WILL IDENTIFY THE BASE OF THE TRIANGLE. AND ON ONE HAND WE NEED TO DEVELOP MORE EFFECTIVE INTERVENTION AND STRATEGIES TO ASSURE PATIENTS THAT BECOME ADDICTED TO NOT OVERDOSE AND FOCUS OUR EFFORTS INTO REVERSING THE OVERDOSES. IN THE PAIN SPACE, I THINK THERE'S CLEARLY ONE OF THE BIG EXCI EXCITEMENTS IS THERE'S BEEN DEVELOPMENTS REGARDING THE MOLECULAR MECHANISMS ASSOCIATED WITH PAIN AND COULD HAVE POTENTIAL FOR MEDICATIONS. SOME INDEPENDENT FROM THE OPIOID RECEPTOR MECHANISMS AND OTHERS THAT I MENTIONED LAST TIME AND HAVE INTERESTING ADVANCS IN OUR UNDERSTANDING IN HOW OPIOIDED HAVE LED TO SPECIALLY NEW WAYS OF ADDRESSING OPIOID AGONIES THAT MAY HAVE PROPERTIES THAT LEAVE THEM MORE DESIRABLE THAN THE CURRENT ONES. WHAT IS VALUABLE FOR ANALGESIC WITH REDUCED SIDE EFFECT. I PRESENTED IT IN A SLIDE AND THAT'S WHERE WE WERE BUT THERE'S THE CONCEPT THAT THEY BIND TO THE PROTEIN SYSTEM AND THERE'S A PROTEIN RESPONSIBLE FOR MANY THINGS AND IT'S ALSO ASSOCIATED WITH TOLERANCE. AT THAT POINT THE UNDERSTANDING WAS WE HAVE MOST DRUGS BINDING TO BOTH OF THEM AND BY UNDERSTANDI UNDERSTANDING THREE-DIMENSIONAL STRUCTURE YOU CAN ASSIGN MOLECULES THAT WILL BIND. SINCE THEN IT HAS BECOME CLEAR IT'S NOT SO POLARIZED AND THERE'S A FUNCTIONALITY AND CAN LOOK AT THE WHOLE ARRAY. AND THE TARGET WOULD BE A COMPOUND THAT ONLY BINDS TO THE G PROTEIN LIKE THIS PURPOSE ONE AND DOESN'T HAVE BETA RESTING. AN UNDESIRABLE DRUG IS ONE THAT BINDS BUT HAS LOW BETA RESTING AND AN THERE'S A DEVELOPMENT MUCH ASSAYS TO SEE WHERE DRUGS STAY IN THE DIMENSION. FENTANYL IS TO THE THE RIGHT. IT'S VERY POTENT AND HIGH ACTIVATION AND IT'S LIKELY TO ACCOUNT FOR THE HIGH MORTALITY. NOW RESEARCHERS, AND THIS A PAPER THAT WAS JUST PUBLISHED ONE MONTH AGO, THERE'S MOLECULES. THERE'S A MOLECULE WITH THE CHARACTERISTICS IN PURPOSE THAT SHOW STRONG ANELGESANELGESIA AND THE PUBLIC AND PRIVATE PARTNERSHIP PLAYS A ROLE. A SECOND PONE -- COMPONENT AND WE HAVE ONE DRUG THAT GETS IN THE OPIOID RECEPTOR RAPIDLY AND DISPLACES IT AND YOU CAN REVERT BREATHING RIGHT WAY. YOU NEED TO ADMINISTER THE DRUG RAPIDLY SO INTRAVENALS ARE GREAT IN A HOSPITAL SETTING BUT WITH A FIRST RESPONDER IT WILL NOT WORK BECAUSE MOST ARE NOT TRAINED FOR THE ADMINISTRATION AND IT'S NOT SO SIMPLE TO START AN INTRAVENOUS INJECTION. WE'VE WORKED WITH TWO COMPANIES TO DEVELOP AN INTRANASAL NALOXONE AND YOU CAN SEE THE SIGNIFICANT BLOCKADE AND THOSE ARE BEING OCCUPIED TO BASICALLY THE SAME EXTENT AS INTRAVENOUS. AND IT SHOWS THE INTRANASAL DRUGS RESULTED IN EQUIVALENT PLASMA LEVELS AND FAST DELIVERY OF THE DRUG AND IT'S NOW THE MAIN PRODUCT UTILIZED FOR REDUCING OVERDOSES. THE CHALLENGE NOW IS THAT PATIENTS OVERDOSING WITH FENTANYL OR BENZO PRODUCTS WE CAN GET THEM TO STAY BLOCKING IT FOR A LONGER PERIOD OF TIME AND PRODUCTS BECAUSE NALOXONE WILL NOT DO IT ALONE AND THAT'S ANOTHER THING WE'RE EXPLORING WITH A PUBLIC/PRIVATE PARTNERSHIP. AND WE'RE LUCKY TO HAVE [INDISCERNIBLE] AND AS I MENTIONED, THE OUTCOMES WHEN YOU INITIATE MEDICATION IT CAN IMPACT EFFECTS. VERY POSITIVE ACROSS EVERY INDICATOR WE HAVE. THE RELAPSE RATES ARE HIGH. AND THIS HIGHLIGHTS TO WHERE WE HAVE TO DETERMINE WHAT IS IT RESEARCH CAN DO IN THOSE SPACES. THEY'RE UNDER UTILIZED. ONE REASON IS BECAUSE THERE'S NOT SUFFICIENT TREATMENT PROGRAMS TO TREAT THE PATIENTS. ITEM NUMBER ONE. THERE'S ALSO AN ISSUE OF STIGMA. THAT'S HARDER TO ADDRESS HOW DO WE IMPROVE CAPABILITIES FOR ADMINISTERING THE MEDICATION TO PATIENT NEED IT. THAT'S FIRST. THE SECOND HAS TO DO WITH IF HALF THE PATIENTS ARE RELAPSING AT SIX MONTHS AFTER MEDICATION-ASSISTED TREATMENT, WHAT CAN WE DO IN THE MEDICATION DOMAIN ITSELF THAT CAN IMPROVE THE COMPLIANCE OF THOSE TREATED AND PREVENT RELAPSES. AND YOU CAN SEE IN BLUE WHAT YOU WANT TO DO IS ASSIST IN AT LEAST SIX-MONTHS IN RECOVERY AND THE RELAPSE IS RISK IS HIGH IN THOSE SIX MONTHS AND IF YOU RELAPSE THE RISK OF MORTALITY IS HIGH. THEY RESTART AND OVERDOSE AND DIE BECAUSE THEY'RE NO LONGER TOLERANT. SO WE CAN IMPROVE BY EXPANDING THE INFRASTRUCTURE AND WE CAN IMPROVE IN RETAINING PATIENTS BY FACILITATING MEDICATION. AS WITH KNOW IN MEDICINE ONE STRATEGY WE'VE USED ALL ALONG EFFECTIVE FOR COMPLIANCE IS EXTEND FORMULATION THAT WILL NOT FORCE THE PATIENT ON A DAILY BASIS TO TAKE IT ON A DAILY BASIS. AND LAST TIME I PRESENTED THE EXTENDED RELEASE NATRAXONE AND YOU GET IT ON A MONTHLY BASIS. THERE'S BEEN ANOTHER APPROVAL AND THIS IS THE PRODUCT RECENTLY APPROVED NOVEMBER 30, 2017. THIS IS THE TYPE OF SUCCESSES WE'VE HAD IN PARTNERING WITH PHARMACEUTICAL INDUSTRY IN ORDER TO BRING EVIDENCE-BASED PRODUCTS INTO THE APPROVAL FOR THE FDA THAT WILL ENSURE AND FACILITATE THEM BEING IN PROGRAMS AND REIMBURSED. PRODUCT.THE DATA FOR THE - THIS IS ANOTHER PROBLEM WE'VE WORKED ON. ONE IS A ONE-WEEK AND THE OTHER IS A ONE-MONTH INJECTABLE. THEY DID A DIFFERENT DESIGN AND THEY HAVE PARTICIPANTS FOR NEGATIVE URINES AND IT'S A HIGHER POWER. WHAT IS REMARKABLE IS YOU CAN ALREADY SEE SIGNIFICANTLY BETTER OUTCOMES IN THE INDIVIDUALS THAT HAVE THE ONE MONTH EXTENDED RELEASE VERSUS THOSE THAT HAVE IMMEDIATE RELEASE. AND I'M NOT SHOWING THE DATA HERE BUT WHAT I FOUND FASCINATING IS WHEN THEY DID QUANTITATIVE ANALYSIS FOR THE CONCENTRATION OF MORPHINE IN THE PATIENTS ON THE EXTENDED RELEASE WAS 70% LOWER THAN THAT ON THE IMMEDIATE RELEASE OF THE PRODUCT HIGHLIGHTING THE OPPORTUNITY OF DEVELOPING TREATMENTS THAT WILL FACILITATE COMPLIANCE IN THE PATIENTS AND PREVENT THEM FROM TAKING [INDISCERNIBLE] . ANOTHER AREA WE'RE FOLLOWING AND IS ACTUALLY NOT IN THE STAGE OF THE -- WHAT ARE THE LOWER HANGING FRUIT IS THE SPACE OF FACILITATING MEDICATIONS WE KNOW WORK AND EASY FOR PHYSICIAN TO WORK WITH. . THE OTHER IS WHERE SCIENCE TAKES US TO NEW OPPORTUNITIES. AS WE KNOW AND CAN INVESTIGATE THE NEUROCIRCUITRY THAT GETS EFFECTED BY ADDICTION AND IT'S PROCESS OF YOU CAN TAKE THE DRUG AND GET INTOXICATED AND THEN GO ACK AND RELAPSE AGAIN. THERE'S A CIRCLING EFFECT. THE ABILITY TO TARGET THOSE NEUROCIRCUITS IS FROM BASIC NEUROSCIENCE RESEARCH. THERE'S OPPORTUNITIES THAT MAY BE AMENABLE IN THE FIVE-YEAR PERIOD TO GET US TO NEW TREATMENTS. THAT'S IN THE DOMAIN OF WHAT MEDICATIONS WE CAN DO THAT WILL MAKE IT EASIER FOR CLINICIANS TO BE ABLE TO -- FOR PATIENTS TO BE ABLE TO TAKE THE MEDICATIONS. THE OTHER IS HOW DO WE EXPAND THE INFRASTRUCTURE. AND LAST TIME I PRESENTED THE DATA SHOWING HAVING PHYSICANS IN EMERGENCY DEPARTMENTS PRESCRIBE MEDICATIONS AT THE TIME THEY'RE IN THE EMERGENCY DEPARTMENT IMPROVES THE ABILITY OF PATIENT TO DECREASE THEIR UTILIZATION OF HEROIN COMPARED TO BRIEF INTERVENTIONS. IT ALSO DECREASE THE NUMBER OF EMERGENCY DEPARTMENT ADMISSIONS POST RELEASE. AND IT WILL FACILITATE THAT RETENTION OF PATIENTS IN CARE. THERE'S MORE THAN EMERGENCY DEPARTMENTS AND AGAIN ONE OF THE AREAS THAT WE'RE FOCUSSING OUR EFFORTS TO EXPAND RESEARCH IS HOW DO WE ENGAGE PRIMARY CARE PHYSICIANS. AND SINCE MANY OF THE OPIOID CRISIS IS IMPROVING IN AREAS IT'S BEEN IMPORTANT TO COLLABORATE WITH QUALIFIED HEALTH CENTER TO IMPLEMENT SOME OF THE STRATEGIES. THESE ARE TWO EXAMPLES OF TWO STUDIES THAT HAVE SHOWN THE COMMUNITY CENTERS CAN HAVE THE STRATEGY OF THE EVENT THAT FOLLOWED THE TREATMENT. AND WHAT IS NOTABLE AND IT'S ASSOCIATED WITH A MODEL THAT ENGAGES NURSES AND IT'S NOT VERY DIFFERENT FROM THE RESULTS WE'RE GETTING ON ACADEMIC CENTERS INDICATED THAT THESE MODELS ARE QUITE EFFECTIVE IN PROVIDING SUPPORT AND TREATMENT FOR THOSE THAT NEED IT. THIS AREA OF RESEARCH OF COURSE IS SOMETHING THAT WE CAN DEMONSTRATE THERE'S THE EVIDENCE. FOR THIS TO BE VALUABLE AND MAKE A DIFFERENCE IN A RELATIVELY SHORT PERIOD OF TIME WE NEED TO ENGAGE THE OTHER PARTNERS AND AGENCIES. SO ON MONDAY, AND YOU SEE FRANCIS THERE AND HE WAS THERE FROM THE BEGINNING TO THE END, WE ORGANIZED A MEETING THAT BROUGHT ALL THESE DIFFERENT AGENCIES THAT ARE PARTNERING AND RESPONSIBLE FOR THE TREATMENT OF MANY OF THESE PATIENTS ACADEMY HEALTH AND POLICY FORUM AND IT REACHES OUT TO FAMILIES WITH ADDICTION AND AGENCY FOR THE AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE AND AMERICAN HOSPITAL ASSOCIATION AND THE POLICY CENTER AND DEFENSE HEALTH AGENCY AND CAL RESOURCES AND SERVICES, NATIONAL ACADEMY OF MEDICINE, YOU CAN SEE EVERYONE WHO WAS THERE. AND THE ACTING SECRETARY ACTUALLY WAS THERE WITH US TOO. WHAT WE ASKED THE ORGANIZATION BEFOREHAND IS TO SEND THE WHAT ARE THE THREE MAIN POINTS THEY THINK WERE KNOWLEDGE-DEVELOPED, THEY WOULD BE ABLE IT DO THEIR JOB BETTER. AT THE END OF THE MEETING AND FRANCIS OPENED THE MEETING AND SAID, WE WANT AN ACTION MEETING. WE WANT AT THE END OF THIS MEETING TO HAVE A BETTER IDEA WE WOULD NOT HAVE HAD OTHERWISE AND THERE'S MANY IDEAS WITH THE PLAYERS IDENTIFYING THE SIX TOP ONES. THEY WERE QUITE SIGNIFICANT IN MY BRAIN BECAUSE I HAVE TO ADMIT ONE OF THEM I HAD NEVER THOUGHT ABOUT IT AND I THINK IT IS A KEY ONE. ESTABLISH WHAT TREATMENTS ARE EFFECTIVE FOR MILD OPIOID USE AND DISORDER. IT DOESN'T CONSTITUTE THE MINORITY OF PATIENTS WHERE INTERVENTIONS ARE LIKELY TO HAVE THE LARGEST IMPACT. THIS CAME ACROSS IN OUR DISCUSSIONS. ALSO THERE WAS CLEARLY THE RECOMMENDATIONS OF STRENGTHENING THE CONNECTION AND MAXIMIZE ALL AVAILABLE DATA SOURCES AND ONE CHALLENGE WE HAVE IN THE SUBSTANCE ABUSE SPACE IS THE PRIVACY REQUIREMENTS TO MAKE IT DIFFICULT TO OBTAIN THE DATA. THERE WAS THE RECOMMENDATION TO LOOK AT CITIES AND SCIENTIST TO DEVELOP OUTCOME INEQUALITY MEASURES. THIS IS VERY WELL -- RELEVANT BUT IT DIDN'T DEMAND QUALITY OF CARE AND IT'S CRUCIAL THAT WE CHANGE THAT. ANOTHER QUESTION THAT EMERGES IS HOW DO YOU DETERMINE WHEN A PATIENT NEEDS IN-PATIENT VERSUS OUT-PATIENT. IT'S VERY EXPENSIVE AND WE DON'T HAVE EVIDENCE TO SHOW ALL PATIENTS BENEFIT FROM IT. AND ADDRESSING TREATMENT INTERVENTION AND THAT TAKES ME TO THE LAST TWO SLIDES ON THE PRESENTATION WE HAD ON TUESDAY AND WEDNESDAY DECEMBER 12 AND 13 ON THE PUBLIC/PRIVATE PARTNERSHIP AND FRANCIS SPOKE TO YOU ABOUT THIS YESTERDAY. HE'S BEEN WORKING NON STOP SINCE APRIL BUT IT WAS BEFORE BECAUSE WHEN HE LAUNCHED THIS HE HAD ALREADY MET WITH ME IN GARNERING THE ENERGY AND THE IMPETUS TO GET PHARMACEUTICAL INDUSTRIES TO BE PART OF THE SOLUTION OF THE CRISIS. AND WITH THE PARTICIPATION WITH MANY HAVE WORKED ON THIS AND THE NOTABLE EFFORT OF REBECCA BAKER, AND LINDA PORTER. IT HAS BEEN A CONSTANT NON STOP. MY WORRY SOMETIMES IS ARE WE BURNING THEM OUT BUT THEY DON'T SEEM TO BURN OUT. EVERYBODY'S VERY ENERGIZED. WE INITIALLY WENT TO THE MEET BEING WITH TWO AREAS, OPIOID USE DISORDERS AND PAIN. AT THE END OF THE MEETING WHAT HAPPENED WAS A RECOGNITION WE NEED TO LOOK AT THE EFFORT BECAUSE THEY'RE INTERMINGLED. THE PUBLIC/PRIVATE PARTNERSHIP IS TO LOOK AT COMBINATION OF MEDICATIONS TO PREVENT OVERDOSES. AND TO REPURPOSE COMPOUNDS THAT MAY BE ACTUALLY USED FOR SOMETHING ELSE THAT MAKE UP OPIOID USE DISORDERS. THOSE ARE THE ONES MORE LIKELY TRANSLATED TO PRODUCTS. AGAIN, HIGHLIGHTING THE URGENT NEED OF MORE POTENT TO LONGER-LASTING OPIOID ANTAGONISTS TO REDUCE OVERDOSES AND I LOOKED AT STIMULANTS FOR RESPIRATION WHICH HAVE NOT BEEN TESTED IN THE PAST. FINALLY, A THIRD ELEMENT THAT CREATED A LOT OF INTEREST AMONG THE PHARMACEUTICALS IS THE END POINTS FOR THE MEDICATIONS THAT WOULD THEN FACILITATE OTHER THAN ABSTINENCE, FACILITATE THEIR APPROVAL BY FDA. AND THEY WERE FINALLY ENDORSED BY THE MEETINGS WE HAD. ONE OF THEM, THE OPPORTUNITY OF DATA SHARING AND REPURPOSING OF COMPOUNDS FOR OPIOID USE DISORDERS AND THE NEED FOR BIOMARKERS AND THIRD IS THE TREMENDOUS VALUE OF CREATING A RESEARCH TRIAL NETWORK THAT WILL FACILITATE ACTUALLY THE CLINICAL TRIALS FOR MEDICATIONS OF PAIN AS WELL AS MEDICATIONS PREVENTING OPIOID USE DISORDERS. WITH THEY END MY PRESENTATION BY SAYING WE'RE MAKING THIS A PRIORITY AND WE LEASED IT TO THE HELP OF MIKE LAUER THE FUNDING OPPORTUNITY ANNOUNCEMENT TO INCENTIVIZE A MECHANISM FOR COMPANIES TO WORK TOGETHER TOWARDS THAT DEVELOPMENT TO THE FAST TRACKING DEVELOPMENT OF OPIOID USE DISORDERS. I'M HAPPY TO ANSWER ANY QUESTIONS YOU MAY HAVE. >> NORRA THANK YOU FOR A LOT OF INFORMATION AND NICELY PRESENTED. QUESTIONS? ROY. >> VERY NICELY DONE. ONE OF THE LONGER TERM STRATEGY IS EDUCATION OF MEDICAL STUDENTS WHICH UNTIL RECENTLY HAS BEEN ALMOST NON EXISTENT. FROM THAT PERSPECTIVE I NOTICE THE EXTENSIVE LIST OF PARTNERSHIPS IT WAS NOT INCLUDED AND INCLUDE THE AAMC, IN THE ONLY HAVE THEY INVOLVED WITH THOSE AREAS OF THE MEDICAL STUDENTS AND RESIDENTS BUT ALSO LCME IN TERMS OF ACCREDITATION IN TERMS OF MEDICAL SCHOOLS. >> BY ALL MEANS. WE'VE REACHED OUT TO THEM AND WE'VE MET WITH THEM AND THE LAST TIME WE MET WAS I THINK LIKE MORE THAN A YEAR AGO, 14 MONTHS AGO AND WE DID NOT ADVANCE VERY MUCH. I THINK THINGS HAVE CHANGED AND IT'S A TIME TO BRING BACK THOSE EFFORTS BECAUSE I COMPLETELY AGREE. ONE OF THE LOWEST HANGING FRUITS IS EDUCATING AND TRAINING THE PROVIDERS IN PAIN AND SUBSTANCE USE DISORDERS. WE HAVE THE CDC GUIDELINES BUT YOU HAVE TO TRAIN PHYSICIANS. AND IN PARALLEL, WHICH HAS BEEN BROUGHT UP MANY TIMES, ENSURE THAT CMS AND INSURANCE WILL COVER FOR THOSE GUIDELINES. >> WE'VE SEEN HOW IMPORTANT TRAINING IS AND WE STARTED TWO INITIATIVES. ONE IS CENTERS OF EDUCATION FOR SUBSTANCE USE DISORDERS AND THE CENTERS FOR EDUCATION OF PAIN HAVE BEEN DONE WITHIN THE PAIN CONSORTIUM AND THE PURPOSE IS TO DEVELOP CURRICULUM THAT WOULD BE OPEN, ACCESSIBLE AND AVAILABLE FOR TRAINING FOR NURSES, PHARMACISTS AND THE PROPER TREATMENT OF PATIENTS WITH PAIN AND WITH PRESCRIPTION OF OPIOIDS. THERE ARE EDUCATIONAL TRAINING MODELS FOR PAIN BUT MANY HAVE BEEN FUNDED BY A PHARMACEUTICAL INDUSTRY AND IT HAS GENERATED THE POTENTIAL ASPECT OF CONFLICT. IT'S SOMETHING WE'RE WORKING WITH ACADEMIC CENTERS TO HAVE THE EXPERTISE TO FACILITATE THE DEVELOPMENT OF THAT CURRICULUM. >> THANKS FOR THAT. I HAVE TWO QUESTIONS. ONE IS THAT YOU'VE SHOWN US SOME AMAZING SCIENCE EVOLVING IN THIS AREA AND LOOKS AT RESEARCH AND IN ADDITION TO BEHAVIORAL SCIENCE. I'M WONDERING HOW YOU'RE ADDRESSING THE DIFFUSION OF BEHAVIORAL SCIENCE IS THE FIRST QUESTION. THE SECOND QUESTION IS, I COULDN'T TELL FROM THE LIST IN YOUR MEETING WHETHER PATIENTS AND THEIR FAMILIES WERE REPRESENTED? >> I HAVE TO ADMIT MY MISTAKES. IT WASN'T UNTIL RECENTLY I BASICALLY HAVE TAKEN ADVANTAGE AND RECOGNIZE HOW IMPORTANT THAT PATIENT ADVOCACY COMPONENT IT. I RECOGNIZE IT BECAUSE I SAW IT BUT THERE WERE NO STRONG GROUPS. NOW THERE'S AN ADDICTION POLICY FORUM AND HAS BEEN ABLE TO RAPIDLY BRING TOGETHER FAMILIES AND PATIENTS. THEY HAVE PARTNERED WITH US AND BEEN SUCH PARTNERS WITH US WE'VE COME TO AN AGREEMENT TO WORK TOGETHER TO GENERATE WHAT'S CALLED PATIENT FOCUSSED DEVELOPMENT WHICH IS PFD BY THE FDA AND STIPULATED ON THE 21st CENTURY [INDISCERNIBLE] TO DETERMINE ALTERNATIVE OUTCOMES FOR PATIENT-BASED OUTCOMES. THEY'VE APPROVED IT FOR FIBROMYALGIA WHICH IS RELEVANT TO WHAT WE'RE DOING THE FDA APPROVED OUR LETTER OF INTENT AND EMBRACED IT WILL COVER THE COST OF EVERYTHING REQUIRED TO BE READY TO HAVE A PROPOSAL IN HOW TO MOVE THEY WERE THERE. WITH RESPECT TO YOUR FIRST QUESTION, HOW WE'LL DO IT. EFFECTIVELY FROM LEARNING FROM PRACTICE TO RESEARCH AND RESEARCH TO PRACT YOU NEED TO CREATE ENVIRONMENTS TO BE FACILITATED. AS A RESULT, THAT WAS A POINT THAT CAME AND EMERGED ALL ALONG OUR DISCUSSIONS. WE'VE HAD A LONG HISTORY OF PARTNERSHIP WITH SAMSA AND THE DIRECT EVER OF THAT AGENCY HAS BEEN ONE OF OUR GRAUNTES. GRANTEES. WE STARTED DISCUSSING OPPORTUNITIES TO CREATE SPACES WHERE WE CAN SEEK RESEARCHERS WITHIN THEIR TREATMENT PROGRAMS OR AGAIN THE GRANTING ORGANIZATIONS TO WHICH THEY'RE GETTING FUNDING TO ENSURE WE CAN LEARN FROM THEM AND IMPORTANTLY AT THE SAME TIME WE CAN LEARN FROM THEM, WE CAN EVALUATE THOSE OUTCOMES SO GOING BACK AND FORTH. AGAIN, I THINK THESE MEETINGS HELPED US CRYSTALIZE ONE OF THE ISSUES WE NEED TO CONFRONT. WE NEED TO FIGURE OUT HOW WE'LL BE WORKING TOGETHER. THE V.A. HOSPITAL WAS INTERESTED SO THERE'S MULTIPLE PARTNERS WE CAN BRING INTO PLAY. >> LOOKED AT CRIMINALITY IS A BIG COMPONENT, IN TERMS OF ENGAGEMENT DO YOU SEE A ROLE IN THE CRIMINAL JUSTICE SYSTEM IN THIS? IT SEEMS CHALLENGING BUT IT SEEMS TO BE A COMPONENT THAT NEEDS TO BE ADDRESSED AND THE OTHER IS RESEARCH-RELATED. NOTHING INCENTIVIZES AN END POINT BECAUSE THAT WILL OPEN THE GATES IN TERMS OF SCIENTIFIC DEVELOPMENT. WE RECOGNIZE HOW IMPORTANT IT IS AND I ONLY HAVE 15 MINUTES AND WE ARE PRIORITIZING WITHIN THE CRIMINAL JUSTICE SYSTEM BECAUSE THERE'S AN URGENCY AND I RECOGNIZE WE CANNOT KEEP OUR EYES OFF THE BALL FROM THE OTHER BALL BECAUSE YOU SEE THE MORALITY FROM COCAINE GOING UP AND POSSIBLY BECAUSE THEY'RE BEING LACED WIN FENTANYL. AND PEOPLE SOMETIMES GET NERVOUS BUT WE NEED TO FOCUS RIGHT NOW THERE'S AN URGENCY. WHAT WE ARE ARE GOING TO BE DOING IS IN OUR CRIMINAL JUSTICE NETWORK OPERATIONS, WE WANT IT FOCUS ON OPIOID DISORDERS. WE CREATED A PARTNERSHIP WITH THE FOUNDATION WHERE THEY'RE GOING TO HELP US BE ABLE TO FUND PROJECT WHEN WE DON'T HAVE SUFFICIENT FOUNDING. WE'RE WORK THE CLINICAL TRIAL NETWORK SO ONCE A PERSON IS RELEASED THEY HAVE THE CRIMINAL COMPONENT -- >> THE SURROGATE END POINTS. >> YOU HEARD SCOTT GOTTLIEB HE WANTED TO PROMOTE ALTERNATIVE END POINTS. [INDISCERNIBLE] IT'S ONE OF THE ONES AND WE HAD DISCUSSIONS AND I SAID WOULD YOU CONSIDER AS AN ALTERNATE OUTCOME PREVENTION OF OVERDOSES BECAUSE WE'RE SEEING THEM IN OUR CLINICAL TRIALS. WE'RE SEEING MANY FATE -- FATALITIES. EVEN IN THE CLINICAL TRIALS WHERE WE DO 200 AND 300 WE'RE SEEING SUFFICIENT OVERDOSES TO MAKE AN EFFECT. >> I WOULD ENCOURAGE YOU TO CONSIDER ADDING THE LAND GRANT UNIVERSITY TO YOUR GROUP OF PEOPLE BECAUSE THEY HAVE AN EXTENSION BECAUSE THEY HAVE DEEP ROOTS AND IN CONNECTING WITH THE COMMUNITY THEY'RE VALUABLE. I'M TROUBLED EVERY TIME I SEE YOUR TALK BECAUSE OF THE DEMOGRAPHIC DIVIDE YOU CAN ALMOST DRAW A LINE IN THE MIDDLE OF THE COUNTRY AND TO THE RIGHT THE MORTALITY RATE IS FAR LESS THAN THE LEFT. CAN YOU ADDRESS WHY YOU THINK THAT IS? WHY IS THERE SUCH A CHANGE WITH THE WESTERN HALF OF THE COUNTRY. >> WHAT IS DRIVING THE FATALITIES AND LOCATION, THERE'S HISTORICAL TRENDS THAT RELATE TO THE USE OF HEROIN. WE KNOW MASSACHUSETTS AND PUERTO RICO AND MARYLAND HAVE LONG HISTORIES OF HEROIN USE SO THE FATALITIES HAVE BEEN HIGH. IN THE APPALACHIAN AREA AND NEW MEXICO, IT IS WRITTEN PRESCRIPTION PREDOMINANTLY AND A COMBINATION WITH ALCOHOL SO THAT COMBINATION IS LETHAL. IN OTHER AREAS IT SEEMS TO BE DRIVEN BY WHERE THE HEROIN HAS DONE ENTRY AND OHIO WAS ONE OF THE FIRST TO BE TARGETED BY THE HEROIN DEALERS. SO CALIFORNIA WAS ONE OF THE FIRST ONES TO BE TIED TO HEROIN COMING FROM MEXICO. SO THERE IS AN ELEMENT THAT RELATES TO MEDICAL PRACTICES. IN SOME COMMUNITIES DRUG DEALERS HAVE IMMERGED THEMSELVES AND IN CHICAGO THERE'S HIGH RATES OF COCAINE. WITHIN ALL THEM WHAT EMERGES CLEARLY IS THIS IS A DISEASE OF DESPAIR. COMMUNITY THAT DON'T HAVE MANY ALTERNATIVES SOCIALLY. SOCIAL ALTERNATIVES AND AT GREATER RISK. THAT'S WHAT WE NEED TO RECOGNIZE. WE ARE ADDRESSING THE ISSUES TO PRE PRESENT REVERSALS OF OVERDOSES. IN THE LONG RUN HOW DO WE ADDRESS THE DISPARITIES. PERHAPS THE OTHER THING I NOTICE IS THE LARGER COUNTIES HAVE HIGH RATES AND MAYBE ACCESS TO MEDICAL ATTENTION IS ONE LOOK AT MORTALITY AND YOU CAN CONCENTRATE ON THE ACUTE OVERDOSE AND REFERRAL TO TREATMENT CENTERS BUT A LOT OF DEATHS ARE PROBABLY HAPPENING IN THE FEEL AND ONE ANALOGY IS HOW THE DEPLOYMENT OF THE DEFIBRILLATORS IN THE COMMUNITY WHETHER THE PERSON WOULD BE ADEQUATELY TRAIN ACTUALLY REVERSES DEATHS. THINKING HOW THE NIH CAN HELP IN THE SITUATION, WHAT EVIDENCE IS BEING GATHERED TO SHOW THE DISSEMINATION OF THE NASAL KITS WITHOUT PRESCRIPTION COULD REVERSE MORTALITY? >> ONE OF THE RECOMMENDATIONS IN THE MEETING WAS TO DO A LARGE PILOT STUDY TO LOOK AT INTERVENTION TO ASK THE QUESTION YOU ARE ASKING. WE HAVE THOUGHT OF THAT ALREADY AND HAVE A PROPOSAL FOR THE PILOT PROJECT THAT WOULD DO A LARGE IMPLEMENTATION TO IDENTIFY WHAT ARE THE ACTIVE INGREDIENTS TO BE SUCCESSFUL. THAT TYPE OF PILOT INTERVENTION LARGE SCALE IS VERY COSTLY. SO WE NEED TO FIGURE OUT HOW TO FUND IT. WE ARE FUNDING AND SEEING SMALLER INVENTION PROJECTS FOR THE ADMINISTRATION OF MEDICATION ASSISTED TREATMENT FOR THE ADMINISTRATION OF NALOXONE AND INTERVENTIONS. WE'RE DOING THIS WITH THEC.D.C. >> SOME STATES ARE MOVING IN THE DIRECTION TO MAKE IT AVAILABLE. >> YOU CAN GET IT OVER THE COUNTER SO ANYONE CAN GET IT AND SO -- THERE HAS BEEN A BIG INVESTIGATE MANY HERE AND THE DATA, AS YOU SHOW IT, SHOWS WE'RE SAVING LIVES AND IT'S ANOTHER AREA THAT HAS TO BE URGENTLY ADDRESSED WHICH IS WHEN YOU OVERDOSE AND YOU END UP IN THE EMERGENCY DEPARTMENT AND THEY'RE RELEASED WITHOUT FOLLOW-UP. SO WHEN A PATIENT GETS IN THE EMERGENCY DEPARTMENT THERE ARE MEASURES TO ENSURE THAT PERSON IS PUT IN SUPPORT OTHERWISE THEY'LL OVERDOSE. >> IT TALKS TO HOW THE POPULATION IS SPREAD OUT AND ONE OF THE GREAT TRAGEDIES IT HOW IT'S HIT RURAL AREAS HARD AND IT MAKES IT DIFFICULT FOR REVERSAL AT THE RIGHT PLACE AT THE RIGHT TIME AND FOR PEOPLE THAT ARE MOTIVATED TO GET INTO A RECOVERY PROGRAM HOW DO YOU DO THAT WHEN THE POPULATION IS LOW AND YOU CAN'T SET UP TOO MANY CLINICS. THERE'S A BIG INTEREST IN TELEMEDICINE WHICH IS PROBABLY ONE OF THE BETTER MOMENTS TO TEST OUT TELEMEDICINE APPROACH AND SAMSA AND OTHERS ARE INTERESTED IN EXPLORING THAT AND AS ARE WE. >> AND WHAT WE'VE DONE RE -- AND IN THE PARTNERSHIP WITH A COMPANY WAS THE FIRST TO BE APPROVED BY THE FDA TO HAVE A PHONE-BASED TECHNOLOGY AND WE'LL WORK WITH THEM AND HOPEFULLY THEY'LL GET APPROVAL NEXT YEAR FOR THE USE OF OPIOID USE DISORDER. AND I CONTACTED THEM AND SAID GUYS, WOULD YOU BE INTERESTED IN THINKING ABOUT THE POSSIBILITY OF DEVELOPING SUCH AN APPLICATION FOR AN EARLY INTERVENTION ON OPIOID DISORDER. THAT'S ANOTHER SPACE WHERE THERE'S UNIQUE OPPORTUNITIES AND FRANCIS AND I HAVE BEEN DISCUSSION OF DISCUSSING IN ONCE WE CONSOLIDATE THE PRIVATE/PUBLIC PARTNERSHIP IS THERE SOMETHING WE CAN HELP MONITOR THE PATIENTS BETTER. >> NORA, I SUSPECT WE'LL KEEP TALKING ABOUT THIS EVERY TIME WE GATHER BECAUSE IT TOOK YEARS TO GET IN THIS MESS BUT WE CAN GET THERE FASTER WITH THE BEST SCIENCE AND THANK YOU FOR LEADING THE EFFORT SO ABLY. ACD MEMBERS, WE HAVE ONE MORE TOPIC TO WALK THROUGH. OUR ALWAYS ABLE, DR. TABAK, WILL TALK ABOUT HOW WE'RE OPTIMIZING SO GET READY. >> THIS IS A DIFFERENT TOPIC THAN I WAS INVOLVED WITH LAST TIME AND IT'S A GOVERNMENT-WIDE EFFORT THE OMB HAS DIRECTED THE ENTIRE U.S. GOVERNMENT TO ENGAGE IN. THE DEPARTMENT OF HEALTH AND HUMAN SERVICES IN RESPONSE TO THIS A DEPARTMENT-WIDE INITIATIVE AS REIMAGINE HHS. THE DEPARTMENT HAS REALLY WORKED HARD TO ENGAGE MANY MANY PEOPLE AT ALL DIFFERENT LEVELS OF THE ORGANIZATION TO IDENTIFY POTENTIAL OPPORTUNITIES TO IMPROVE OUR ABILITY TO SERVICE THE AMERICAN PEOPLE. LET ME GIVE YOU A BRIEF OVERVIEW OF THE HHS PLAN. IT BEGAN WITH AN OUTLINING OF PRINCIPLES OUTLINED THERE AND THIS IN TURN WAS INFORMED BY GAO AND OIG RECOMMENDATIONS. WE THEN HAD A SUMMIT, IF YOU WILL, FOR A COUPLE WEEKS WHICH INVOLVED OVER 150 PEOPLE FROM ACROSS HHS. DURING THAT PERIOD OF TIME THERE WERE MANY SUCTIONS MADE. AND THEY -- SUGGESTIONS MADE AND THEY RANGE FROM GLOBAL TO GRANULAR THINGS. SOME WERE COLLECTED AT THE SO-CALLED IDIATION SUMMIT. AT THE END THEY HAD ALMOST 2,000 IDEAS THAT WERE UNIQUE. AND THEY DISTILLED THOSE IDEAS AND IT SHOWED THE STRATEGIC SHIFTS AND THEY'RE LISTED THERE. AND MAYBE SOME DONE ALIGN WITH WHAT WE DO BUT LEVERAGING THE POWER OF DATA. AND THOSE WERE USED TO CREATE A SERIES OF PROPOSALS. WE'RE NOW AT THE POINT OF BUILDING IMPLEMENTATION PLANS ALTHOUGH, NIH IS BEYOND THAT. ALL THAT PRECEDED THIS REFINED AND RETHOUGHT, ETCETERA. THERE IS NOW THE POINT WHERE IMPLEMENTATIONS HAVE BEGUN TO OCCUR. NOW, AS YOU CAN READ UNDER THE MULTI-YEAR IMPLEMENTATION, AND THERE WERE TEAMS OF CODERS CAME TO HHS AND FILLED THE ENTIRE GREAT HALL IF YOU'VE BEEN TO HHS, AND THEY WERE GIVEN ACCESS AND ASKED TO COME UP WITH NEW WAYS OF AND LAYING -- ANALYZING THINGS AND SO FORTH. I'M TOLD THEY CAME UP WITH NOVEL IDEAS. THAT'S AN EXAMPLE OF SOMETHING THAT'S HAPPENED. TO GIVE AN EXAMPLE HOW IT'S BEING RUN, THE SECRETARY'S ALL IN ON THIS. CURRENTLY WE HAVE AN ACTING SECRETARY THE COMMITTEE IS REFERRED TO AS THE RE-IMAGINED HHS COMMITTEE CHAIRED BY THE DEPUTY SECRETARY OF HHS. NOW, CURRENTLY THE DEPUTY SECRETARY OF HHS IS THE ACTING SECRETARY OF HHS AND IS BEING LED BY AN ASSOCIATE DEPUTY SECRETARY. ONCE A PERMANENT SECRETARY IS APPOINTED, MR. HARGAN WILL TAKE LEADERSHIP IN HIS ROLE AS THE DEPUTY SECRETARY. AND THE DEPUTY DIRECTOR AND I ARE UP THIS AD HOC ADD ADVISER SPACE. EACH ARE BEING RUN BY AN INDIVIDUAL GIVEN RESPONSIBILITY FOR THIS SO-CALLED STRATEGIC SHIFT EXECUTIVES. ALL THIS WILL BE IN PART ENABLED BY THE CREATION OF A TRANSFORMATION MANAGEMENT OFFICE AT HHS BUT THEY WILL PROVIDE ACROSS THE DEPARTMENT SERVICE WHERE REQUIRED. SOME WE CAN DRAW UPON BUT NOT EVERY STAFF HAS EQUAL REQUEST AND ANALYTIC SPACE AND SO FORTH. SO THE STRATEGIC SHIFTS ARE LISTED HERE AND THE RESPONSIBLE PERSON DISPLAYED. I'LL HIGHLIGHT THOSE DIRECTED TO NIH. AND I KNOW THOSE IN ACADEMIA WOULD BE SHOCKED TO KNOW DIFFERENT PARTS OF OUR ORGANIZATION DON'T NECESSARILY SHARE DATA BECAUSE AT THE UNIVERSITIES -- YEAH, RIGHT, OKAY. GENERATING EFFICIENCIES THROUGH STREAMLINED PROCESSES. IT'S ALL ABOUT GRANTS AND WE HAVE BEEN WORKING CLOSELY IN THIS SPACE WITH OUR HHS COLLEAGUES FOR A VARIETY OF REASONS. ONE, OBVIOUSLY NIH HAS ENORMOUS EQUITY IN THE GRANTS BUSINESS AND WE HAVE A GREAT DEAL OF EXPERIENCE. ALSO A GRANT IS NOT A GRANT. AND MANY ARE BLOCK GRANTS TO STATES. THOSE ARE DIFFERENT THAN THE INDIVIDUAL AWARDS WE MAKE TO INSTITUTIONS AROUND THE COUNTRY TO SUPPORT RESEARCH. SO WE HAVE SPENT A RATHER LARGE AMOUNT OF TIME BOTH INFORMING AND HELPING OUR COLLEAGUES IN THIS SPACE. RESTORING MARKET FORCES THIS IS OSTENSIBLY RELATED TO CLINICAL TRIALS AND IT'S ALL ABOUT THE JUXTAPOSITION OF FDA AND CMS. IT'S FURTHER THE SPACE NIH NORMALLY ENGAGING IN. AND THERE'S A CMA HANDOFF OR ENGAGEMENT. THOUGH WE ARE NOW IDENTIFYING FOLKS WHO CAN HELP INFORM THE AREA FROM NIH. MOVING TO A 21st CENTURY WORKFORCE AND JOHN CORDOVA IS THE SSC AND THIS IS ABOUT HUMAN RESOURCE AND THE TENANTS ARE THOSE WHICH I'M SURE YOU ALL SUBSCRIBE TOO -- TENENTS -- TENANTS YOU EMPLOY AND IT WILL COME IN PART THROUGH SHARED DELIVER OF CORE FUNCTION. THERE'S EQUITIES IN THIS SPACE WE CAN CONTRIBUTE AND THE IDEA IS TO AVOID DUPLICATION AND CREATE SUPPORT OF HR SERVICES. AND WE'VE HAD A WONDERFUL PARTNER AND THE OVERALL ARCHING GOAL IS WRITTEN HERE AND NIH IS A PILOT FOR THE REST OF THE DEPARTMENT SO FIGURE OUT HOW TO INCREASE COLLABORATION AND RESEARCH SHARING WITHIN AN AGENCY. WE WERE GIVEN THE OPPORTUNITY AND THE CHALLENGE OF FIGURING OUT WHAT WOULD NIH DO IN THIS SPACE TO ENHANCE RESOURCE UTILIZATION. AND THERE'S AN INITIATIVE WE'RE CALLING OPTIMIZE NIH. WANT TO EMPHASIZE THIS PLAN IS SOMETHING NIH LEADERSHIP HAS DEVELOPED. OF COURSE WE HAVE INFORMED THE DEPARTMENT. THERE'S BEEN SOME ITERATION BUT THIS IS AN NIH PLAN. AND WE HAVE SUPPORTED OUR RESEARCH AND TRAINING MISSION WHILE MAINTAINING OUR AMAZING WORKFORCE. SO LET ME SUMMARIZE WHAT WE'RE DOING. WE HAVE A DECENTRALIZED ORGANIZATION AND ALL OF YOU ARE ALL TOO FAMILIAR WITH THAT. IT IS CONCEIVABLE INEFFICIENCIES CREEP IN PARTICULARLY IF YOU HAVEN'T LOOKED AT THEM IN A NUMBER OF YEARS. ADDITIONALLY, PROCESSES PUT IN PLACE MANY YEARS AGO MAY NOT BE AS EFFICIENCY BECAUSE WE'RE NOT TAKING FULL ADVANTAGE OF TECHNOLOGIES. THINGS LIKE COMPUTERS WHICH ALLOW YOU TO DIGITIZE PAPER. SO WE STILL USE A LOT OF PAPER AROUND NIH. MOUNDS AND MOUNDS OF PAPER. THEY DO ENHANCE THINGS AND STREAMLINE THINGS. SINCE THE FOCUS OVERALL IS TO IMPROVE EFFICIENCY, EFFECTIVENESS AND ACCOUNTABILITY, NIH HAS COME UP WITH A PLAN, AN APPROACH TO BEGIN TO DO THIS WITHIN OUR SPACE. SO OUR INITIAL FOCUS WILL BE ON THREE ADMINISTRATIVE SUPPORT AREAS WHICH ARE CRUCIALLY IMPORTANT TO THE MISSION OF THE AGENCY. ETHICS, FREEDOM OF INFORMATION AND COMMITTEE MANAGEMENT AND A CRUCIAL PART OF ADDRESSING THIS IS THE PROPOSED CHANGES WILL OCCUR AS A RESULT OF A DETAILED PROCESS REVIEW OF THE STAKEHOLDERS THEMSELVES. WE'LL BE DEPUTIZING WILL MAKE RECOMMENDATIONS ON DOING THINGS BETTER OR MORE EFFICIENTLY. IT'S GOING TO BE A TEAM-SHARED EFFORT. I WAS GRATIFIED BY THE POSITIVE FEEDBACK WE'VE RECEIVED WHICH I CAN SUMMARIZE BY WE'RE IN IT TOGETHER. SO THE GOALS ARE LISTED HERE. SO PROCESS AND MAP ALL FUNCTIONAL AREAS AND FIGURE OUT THE ABILITIES FOR IMPROVEMENT AND DO DETAILED PROCESS REVIEW AND THEN DO AN AUDIT TO SAY, OKAY, WHEN WE DO THINGS THIS DIFFERENT WAY DO YOU NEED A DIFFERENT COMPLIMENT OF PEOPLE OR DIFFERENT FUNCTIONS. THEN WE DO A BUDGET USING ACCOUNTABILITY-BASED PRINCIPLES. IN THE GOVERNMENT THIS IS AN UNUSUAL, NOVEL AND SCARY IDEA BUT YOU PROBABLY LIVE THIS EVERY YEAR OF YOUR LIVES. AND WE IS THE DEPUTY DIRECTOR FOR MANAGEMENT AND OUR LIAISON TO HHS, I HAVE A TO-BE NAMED PERSON AND JULIE IS HERE. AND JOHN BERKLOW AND JOHN HALLETT AND CARRIE WOLINETZ WHO WAS HERY HERE YESTERDAY. EACH HAS LINKAGE TO THE FOLKS IN INSTITUTES AND CENTERS WITHIN THEIR SPECIFIC DOMAINS OF EXPERTISE. AND YOU HAVE THOSE THAT WORK CLOSELY WITH ME. AND WE HAD A GUEST HERE TWO DAYS WHEN WE LOOKED AT THIS AND SO WHAT WE ARE IN THE PROCESS OF DOING NOW AND WILL MEET WITH THE TEAMS NEXT WEEK AND I BELIEVE THE TIME IS BEING SET, STAFF TO HELP WITH PROCESS MAPPING. SOME FROM THE TIME YOU USED TO DO THESE BIG LONG SHEETS THAT WENT AROUND THE ROOM WE CAN DO THAT BETTER NOW. WE'LL HAVE EXPERTS FROM THE COMMUNITY AND WHAT WE TOLD COMMUNITY MEMBERS AT THE TOWN HALL MEETING IS NO MATTER WHAT THE NUMBER IS WE'LL BRING IT BACK TO THE GROUCH AS A WHOLE SO THEY'LL HAVE THE FEEDBACK LOOP WHETHER THEY PARTICIPATED DIRECTLY THE WHOLE COMMUNITY WILL BE ABLE TO WEIGH IN. SO HERE WE ARE. THIS HAS BEEN A PRETTY INTENSE WEEK FOR A LOT OF REASONS. FRANCIS TEASED EACH OTHER BECAUSE WE CAN'T BE AT THE SAME PLACE AT THE SAME TIME AND IT WAS AN INTENSE WEEK. YESTERDAY DURING THE ACD MEETING WE SENT OUT AN ALL-HANDS E-MAIL SAYING THIS IS WHAT'S GOING ON AND THERE'LL BE A VIDEO RELEASE. AND SECRETARY HARGAN PROVIDES AN INTRODUCTION AND THERE'S A VIDEO -- >> WILL BE A CLASSIC. >> YES. SO ANY OF YOU INVOLVE IN A CHANGE MANAGEMENT ISSUE KNOW IT'S COMMUNICATE AND THE SECOND RULE IS COMMUNICATE AND THE THIRD RULE COMMUNICATE MORE. WE'RE TRYING TO BE AS OPEN AND TRANSPARENT AS POSSIBLE. WE'LL ALSO HAVE AN INTRANET PAGE. THERE'LL BE MANY WAYS OF PROVIDING FEEDBACK. EACH INSTITUTE AND CENTER HAS A DESIGNATED POINT OF CONTACT. BEFORE WE HAD THE TOWN HALL MEETING THE POINT OF CONTACT MET WITH THE INDIVIDUAL EMPLOYEES. A LOT OF THOUGHT HAS GONE INTO THIS. THE GROUP OF INDIVIDUALS THAT I LISTED AS PART OF THE OVERALL EXECUTIVE COMMITTEE IT'S BECAUSE OF THEIR CLEAR THINKING AND CAREFUL PLANNING. WE'RE OFF TO THIS VERY NICE START. SO HIRING SO YOU ALL KNOW HOW THIS PLAYS INTO THE DAY-TO-DAY LIVING. THE DEPARTMENT ACCEPTED OUR PLAN AND SO FULL AUTHORITY TO HIRE WAS PROVIDED TO THE NIH DIRECTOR IN MID OCTOBER. WHAT WE NEED TO DO GOING FORWARD IS MAKE SURE OUR HIRING IS IN ALIGN MANY WITH OUR OPTIMIZE NIH PLAN SO WE'RE NOT AT ODDS WITH ONE ANOTHER AND WORKING THROUGH THAT AND I WOULD THINK NEXT WEEK SAY SHORT WEEK BECAUSE OF HOLIDAYS BUT BY THE END OF THE CALENDAR YEAR WE'LL BE IN A REGULAR CADENCE AND INSTITUTES AND HIRING WILL BE BACK TO A MORE REGULAR ROUTINE WHICH OF COURSE IS WELCOME TO ALL OF THEM. SO WITH THAT I'LL BE HAPPY TO ANSWER ANY QUESTIONS YOU MAY HAVE BUT WE WANTED THE ACD TO KNOW ABOUT THIS SINCE IT WILL BE SOMETHING FOLKS MAY MENTION TO YOU NOW THAT WE HAVE FORMALLY ROLLED IT OUT IT SEEMED LIKE AN OPPORTUNE TIME FOR A QUICK CONVERSATION. I KNOW THIS IS THE ONLY THING STANDING BETWEEN YOU AND YOUR TRAINS, PLANES AND CARS BUT HAPPY TO ANSWER ANY COMMENTS. >> I THINK ANY ORGANIZATION THAT GOES THROUGH THE CHANGE MANAGEMENT THERE'S TWO OUTCOMES. ONE IS THE INVESTMENT IN TECHNOLOGY AND INFRASTRUCTURE. THE ARGUMENT HAS ALWAYS BEEN IT PAYS FOR ITSELF OVER TIME. OBVIOUSLY THAT'S NOT HOW THE GOVERNMENT BUDGET WORKS. IN FACT IN THE AREA OF TECHNOLOGY WE HAVE MORE FLEXIBILITY IN TERMS OF OUT YEAR COMMITMENT. IF WE NEED TO DIGITIZE SOMETHING NOW PAPER BASED COULDN'T HAVE TO MAKE THE INVESTMENT IN THE ONE FISCAL YEAR. WE CAN SPREAD IT OUT. THE SECOND OUTCOME IS THE OUTSIZING OF THE WORKFORCE. THAT CAN EFFECT MORALE TREMENDOUSLY. AND FEDERAL WORKERS WHO WANT TO WORK AT NIH WILL CONTINUE TO BE ABLE TO WORK HERE AT NIH. NOW, WILL EVERYBODY HAVE THE EXACT SAME JOB THEY HAVE TODAY? I DON'T KNOW THE ANSWER TO THAT BECAUSE AS YOU DO PROCESS MAPPING YOU MAY LEARN THE PERSON WHO WAS STAMPING THE PAPER FORMS THAT NO LONGER EXIST CREATE A CERTAIN CATEGORY. IF FOR SOME REASON THAT PERSON'S FUNCTION IS NO LONGER THE ONE YOU NEED, YOU EITHER RETRAIN THAT INDIVIDUAL TO DO THE NEW FUNCTION OR PROVIDE THAT INDIVIDUAL WITH A NEW EMPLOYMENT OPPORTUNITY WITHIN THE NIH. THERE'S NO INTENTION IN REDUCING THE WORKFORCE. >> I'M WONDERING IF YOU HAVE METRICS FOR SUCCESSFUL OPTIMIZING NIH AND OVER WHAT TIME FRAME? >> IN THESE THREE SPACES WE HAVE GOOD BENCHMARKS. THE TIME IT TAKES TO PROCESS YOUR ETHICS FORMS -- BY WAY OF EXAMPLE -- AND THE TIME IT TAKES TO RESPONSE TO A REQUEST AND THERE'S OTHER MEASURES ONE CAN USE BUT YOU'RE QUITE RIGHT. AS PART OF THIS WE'LL HAVE TO DEVELOP A SET OF MEASURES SO AT THE END WE'RE ABLE TO SAY WITH CLARITY, WE HAVE MADE NO DIFFERENCE, WE HAVE MADE IT WORSE, OR IMPROVED IT. >> I HAVE LOST COUNT OF HOW MANY FULL-TIME JOBS WE'RE UP TO BUT YOU HAVE HANDLED IT WITH GRACE AND SKILL AND WHY WE CONTINUE TO OPERATE IN A REMARKABLY EFFICIENT WAY. I THINK WE HAVE REACHED THE END OF OUR AGENDA. LET ME ONE MORE TIME THANK GRETCHEN AND CINDY BEHIND ME FOR KEEPING TRACK OF THE LOGISTICS FOR THIS IMPORTANT GATHERING AND LARRY FOR SHOULDERING THE PLANNING AND DOING A NUMBER OF PRESENTATIONS HIMSELF. AND I DO SAY GOOD-BYE WITH A TEAR IN MY EYE BECAUSE IT'S THE LAST SCHEDULED MEETING FOR FIVE OF YOU. WE'LL HAVE A NEW BUNCH OF FACES IN JUNE. THEY'LL HAVE A HARD TIME LIVING UP TO THE STANDARDS SET BY OUR RETIRING GROUP BUT I'M SURE THEY'LL STRIVE THEIR BEST TO DO SO. FOR ME GOING ON NINE YEARS AS AN NIH DIRECTOR, THIS KIND OF GATHERING WE'VE HAD OVER THE LAST DAY AND A HALF IS INCREDIBLY VALUABLE. THE ABILITY TO PICK SUBSTANCIVE -- SUBSTANTIVE TOPICS AND WE TRY VERY HARD NOT TO EVER CONSIDER THE ACD AS A RUBBER STAMP FOR ANYTHING AND YOU WOULDN'T LET US DO THAT ANYWAY. SO YOU WILL TRAVEL BACK TO WHERE YOU CAME FROM OR WHEREVER IT IS YOU'RE GOING NEXT. I'M HOPING YOU WILL GET A LITTLE BIT OF A BREAK AT THIS HOLIDAY SEASON BUT WON'T FORGET ABOUT ALL OF US. YOU'LL HAVE US IN YOUR BEST WISHES AND HOPES FOR THE NEW YEAR BECAUSE WE'LL HAVE A WILD 2018. MANY THANKS WE ARE ADJOURNED.