SO GOOD MORNING. I'M FRANCIS COLLINS, AS YOU MIGHT HAVE FIGURED OUT. THE DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH JUST FINISHED CELEBRATING 10 YEARS IN THIS ROLE WHICH IS SOMETHING I NEVER QUITE EXPECTED WOULD BE PART OF MY SERIES. THAT WAS NOT INTENDED AS AN INDUCEMENT OF PLAUS BUT THANK YOU. -- OF APPLAUSE BUT THANK YOU. LIFE DOES HAVE TWISTS AND TURNS. WE'RE GATHERED HERE FOR TODAY AND TOMORROW WITH A VERY SERIOUS SET OF TASKS IN FRONT OF US. LET ME JUST AGAIN RESTATE WHY THIS IS SUCH A CRITICAL ISSUE AS OUR NATION CONTINUES TO BE FACED WITH A MAJOR PUBLIC HEALTH EMERGENCY OF DEATHS FROM OPIOID OVERDOSES, ADDICTION AND SUFFERING FROM CHRONIC PAIN. STILL, DESPITE WHAT MAY BE A SLIGHT IMPROVEMENT IN THE STATISTICS WE'RE STILL LOSING MORE THAN 100 PEOPLE A DAY TO OPIOID OVERDOSE DEATHS. WE HAVE ROUGHLY 2 MILLION ADDICTED INDIVIDUALS. MOST OF WHOM ARE NOT IN EFFECTIVE THERAPEUTIC PROGRAMS AND WE HAVE MILLIONS WHO SUFFER FROM CHRONIC PAIN FOR WHOM THE USE OF OPIOIDS IS CLEARLY NOT A GREAT SOLUTION AND FOR WHICH OTHER ALTERNATIVES ARE NEEDED. WE AT NIH BELIEVE WE CAN CONTRIBUTE TO FINDING SOLUTIONS TO THOSE REALLY SERIOUS PROBLEMS BY BRINGING THE BEST SCIENCE TO BEAR UPON IT AND WE HAVE BEEN IN AN ALL-HANDS-ON-DECK MODE ABOUT THIS CRISIS FOR YEARS AND INTENSIVELY SO OVER THE LAST COUPLE YEARS AS CONGRESS HAS PROVIDE US WITH ADDITIONAL RESOURCES AND ADDITIONAL MOTIVATION TO REACH OUT ACROSS DIFFERENT AREAS OF NIH RESEARCH AND MAKE SURE WE'RE COMING UP WITH THE MOST CREATIVE SOLUTIONS THAT WE CAN ON THE BASIS OF GOOD SCIENCE TO THIS CRISIS. SO MANY OF US ARE FINDING OUR HOURS AND DAYS AND WEEKS ARE CONSUMED BY THIS. BUT IN A GOOD WAY AND BECAUSE THAT'S REALLY WHAT WE'RE CALLED TO DO AT THIS PRESENT TIME. AND WE'RE GRATEFUL, VERY MUCH, TO ALL OF YOU FOR BEING HERE. LET ME SAY HOW GRATEFUL I AM TO THE EXECUTIVE COMMITTEE OF INSTITUTE DIRECTORS AT NIH WHO HAVE PUT THEMSELVES ON THE FRONT LINES HERE OF TRYING TO FIGURE OUT HOW WE CAN BEST UTILIZE THE RESOURCES THAT WE'VE BEEN GRANTED. I THINK ALL OF THEM EXCEPT PERHAPS JOSH GORDON WHO IS OFF IN PERU I THINK THE REST OF THE EXECUTIVE MEMBERS OF THE COMMITTEE ARE HERE AND WELL ENGAGE WITH YOU THROUGH THE COURSE OF THE DAY'S DISCUSSION AND I'LL ASK PEOPLE TO INTRODUCE THEMSELVES AROUND THE TABLE TO SEE WHO THEY ARE. AT A SHOUT OUT TO THE PROGRAM STAFF AT NIH. A LARGE GROUP OF PEOPLE FROM MANY DIFFERENT INSTITUTES WHO HAVE OTHER DAY JOB RESPONSIBILITIES BUT MADE IT HIGH PRIVATE TO PULL TOGETHER A PROGRAM YOU'LL LOOK AT INVOLVING NO LESS THAN 26 INITIATIVES AND MORE THAN 40 RFAs. ALL DESIGNED TO MAKE THE BEST USE OF THE RESOURCES WE HAVE TO INITIATIVE AND PUT INTO THE PROGRAM AND THAT NOW IS $500 MILLION A YEAR AND BECAUSE WE CARRIED OVER SOME OF THIS WITH PERMISSION FROM FY18 AND THEN ADDED THAT TO '19, WE'RE TALKING ABOUT OVER $900 MILLION THAT NEEDS TO BE INVESTED IN RESEARCH ON OPIOIDS AND PAIN BY SEPTEMBER 30. SO IT IS THAT PORTFOLIO THAT WE ARE ASKING YOU TO HELP US SIFT THROUGH. WE'RE PARTICULARLY ASKING YOU TO NOT THINK OF YOURSELVES AS A STUDY SECTION. LET'S BE CLEAR. STUDY SECTIONS HAVE ALREADY CARRIED OUT THEIR ROLES IN LOOKING AT THE RESPONSES WE GOT FOR THE FOAs AND YOU'RE NOT A COUNCIL EITHER. YOU'RE BASICALLY A HIGH-LEVEL GROUP TO HELP US PARTICULARLY ASSESS DO WE HAVE THE BALANCE RIGHT IN THIS PORTFOLIO. HAVE WE ACTUALLY COVERED THE KINDS OF BASES THAT YOU WOULD EXPECT FOR A PROGRAM OF THIS SORT TO INCLUDE. AND WE SUSPECT IT WILL BE CHALLENGING OVER THE COURSE OF THE NEXT COUPLE DAYS AS WE TRY TO HIT THE SWEET SPOT. WE DON'T WANT TO DELVE DOWN IN THE WEEDS ABOUT DEBATING THE MERITS OF A PARTICULAR APPLICATION BECAUSE THAT'S WHAT THE STUDY SECTIONS HAVE DONE BUT WE WANT YOU TO SAY DOES THIS PORTFOLIO LOOK RIGHT AND WILL BE ASKING TO YOU DO SO. BEFORE WE GO FURTHER, I'LL ASK PEOPLE AROUND THE TABLE QUICKLY TO SAY WHO YOU ARE AND SO WE ALL KNOW BECAUSE I KNOW IT'S BEEN A LITTLE WHILE SINCE WE LAST MET AND THEN I'LL HAVE A COUPLE MORE REMARKS AND THEN WE'LL GET INTO THE MEAT OF THE MEETING. MAYBE WE CAN START DOWN AT THE FAR END IF YOU DON'T MIND INTRODUCING YOURSELF WITH A SENTENCE AND WE'LL COME THE TABLE AND THEN SEE WHO'S HERE. >> ERIC GARLAND UNIVERSITY OF UTAH PROFESSOR IN THE SOCIAL WORK AND DIRECTOR OF MINDFULNESS AND INTEGRATION DEVELOPMENT. >> CHRIS BEASLEY OF THE CHRONIC BEAN RESEARCH MINDS. >> PROFESSOR OF PSYCHIATRY AT COLUMBIA UNIVERSITY MEDICAL CENTER. >> AL EN BESBONN PROFESSOR OF ANATOMY CHAIR OF THE DEPARTMENT AT UCSF SAN FRANCISCO. [OFF MIC] >> THE MICROPHONES ARE ALWAYS CONFUSING. IT'S THAT BUTTON THAT LOOKS LIKE SOMEBODY'S THROWING UP YOU WANT TO TOUCH LIGHTLY. >> UNIVERSITY OF CALIFORNIA SAN DIEGO, COGNITIVE SCIENCE, PSYCHIATRY AND RADIOLOGY AND CO-DIRECTOR OF THE ABCD STUDY. >> MARTHA SUMMERMAN NATIONAL INSTITUTE OF CRANIORESEARCH. >> DIANA BIANCHI. >> BOB GARDENER IN MUSCULOSKELETAL SKIN DISEASES. >> DIRECTOR OF THE HEAL INITIATIVE AND THOEFS DIRECTOR. >> LARRY TABAK PRINCIPLE DEPUTY DIRECTOR OF NIH. >> NORAH VOLKOW. >> NATIONAL CENTER FOR TRANSLATIONAL SCIENCES. >> OF THE NATIONAL CENTER OF INTEGRATIVE HOUSE. >> FROM THE UNIVERSITY OF VERMONT. >> CHIEF SCIENTIFIC OFFICER AT XAVIER. >> I'M FROM WASHINGTON UNIVERSITY IN ST. LOUIS AND DIRECTOR OF THE WASH-U PAIN CENTER. >> I'M FROM NORTHWESTERN IN CHICAGO THE DIRECTOR OF THE CANCER PAIN PROGRAM. >> PFIZER. >> KAISER PERMANENTE FROM SEATTLE AND DEPARTMENT OF PSYCHIATRY. >> UNIVERSITY CHAPEL HILL. >> WE EXPECT EVERYBODY IN THE MDWG AND WE ARE KNOWING PATRICE HARRIS HAD HER FLIGHT CANCELLED BUT IS EXPECTED TO APPEAR A LITTLE LATE. AGAIN, MANY THANKS TO ALL OF YOU BECAUSE WE DELUGED YOU WITH A LOT MATERIAL AND ASKED YOU TO COME IN THE DOG DAYS OF AUGUST WHEN MANY PEOPLE WOULD LIKE TO BE AT THE BEACH AND HAD TO WORK WITH US INTENSIVELY OVER THE COURSE OF THE NEXT COUPLE OF DAYS. IN TERMS OF WHAT WE'RE DOING RIGHT NOW, WE'RE GOING TO START OFF WITH AN OPEN SESSION AND TALK TO YOU ABOUT A COUPLE OF PROGRAMS FOR CONTEXT THAT HAVE ALREADY HAD DECISIONS MADE BUT WE THOUGHT YOU NEEDED TO KNOW WHERE WE STAND WITH THOSE AND IN A MOMENT REBECCA BAKER WILL GO OVER THE ENTIRE AGENDA. AGAIN, WE WILL TRY TO USE THIS DIAGRAM WHICH YOU SAW THE LAST TIME AS SORT OF THE YOU ARE HERE PART BECAUSE THIS IS TO BE HONEST A VERY COMPLEX SET OF PROGRAMS AND TO FIGURE OUT WHERE YOU ARE TAKES ORIENTATION. WE DIVIDED THESE UP INTO A SERIES OF SIX THEMES SOME DEDICATED ENHANCING PAIN MANAGEMENT AND OTHERS THROUGH MISUSE OF OPIOIDS AND WITHIN THOSE THERE'S SIX PROGRAMS AND WE'LL TRY TO KEEP YOU ORIENT POPPING THIS THING UP AS BEST WE CAN. NO MATTER WHAT YOU'RE AREA OF EXPERTISE AND WE HAVE LOTS OF THAT INPUT AND WE NEED TO KNOW WHICH AREAS YOU THINK ARE POISED FOR PROGRESS. WE WANT TO KNOW IF YOU SEE GAPS WE HAVE NOT ADEQUATELY COVERED IN THE BOLD ATTEMPT TO GET THE LANDSCAPE ATTENDED TO BECAUSE ULTIMATELY WE'LL BE CONTINUING THE PROGRAM NEXT YEAR AND THE YEAR AFTER. IF THERE'S THINGS WE FAILED TO COVERED ADEQUATELY WITH OUR CURRENT SET OF INITIATIVES WE'D LIKE TO HEAR THAT FROM YOU AS WELL. WE'LL TRY TO HAVE THE AGENDA ORGANIZED SO THERE'S LOTS OF TIME FOR DISCUSSION. SOMEBODY IN THE ROOM, MAYBE EVEN ME, WILL TRY TO KEEP TIME SO WE DON'T COMPROMISE AND MAYBE THERE'LL BE MORE TIME FOR THINGS SCHEDULED AND MAYBE OTHERS WILL GO SWIFTLY BUT WE NEED TO GET THROUGH THIS VERY BUSY AGENDA IN THE COURSE OF TODAY AND TOMORROW. I'LL TRY TO BE HERE AS MUCH AS I POSSIBLY CAN FOR BOTH DAYS. I KNOW I WILL NEED TO BE ABSENT FOR SOME PART OF TOMORROW FOR A FAMILY ISSUE BUT OTHERWISE YOU WILL MOSTLY SEE ME SITTING IN THIS CARE. LARRY TABAK DELAYED HIS TRIP TO ALASKA IN ORDER TO BE HERE FOR THIS MORNING. I KNOW HE HAS TO MAKE GOOD ON THAT COMMITMENT LATER ON TODAY. AGAIN, MANY INSTITUTE DIRECTORS PUT ASIDE WHAT THEY'D NORMALLY BE DOING FOR THESE TWO DAYS TO BE WITH US AND WE APPRECIATE THAT. WITHOUT FURTHER DO IT'S TIME TO GET TO WORK AND LET ME TURN IT OVER TO DOCTOR BAKER THE DIRECTOR OF THE HEAL INITIATIVE TO WAKE YOU THROUGH THE AGENDA AND THEN WE'LL GET UNDERWAY. >> THANK YOU, FRANCIS. I'D LIKE TO ECHO THE THANKS TO OUR WORKING GROUP WHOSE BEEN FLEXIBLE AS WE EXTEND THE MEETING TO BE A TWO-DAY MEETING IN AUGUST. OUR INSTITUTE DIRECTORS AND THE SCIENTIFIC LEADERSHIP WHO'S TAKEN CHARGE AND BUILT THE INITIATIVE IN THE PAST YEAR. ALL THE PROGRAMS YOU SEE TODAY WERE JUST GLIMMERS IN OUR EYE A YEAR AGO. SINCE THEN ALL THE PROGRAM LEADS AND SCIENTIFIC LEADERSHIP HAVE WORKED HARD TO GET THEM TO THE STATE YOU'LL SEE THEM IN TODAY SO THANK YOU TO ALL OF YOU FOR THAT. SO AS AN OVERVIEW OF THE AGENDA, IT'S BROKEN OUT IN TO TWO DAYS. WE'LL FOCUS TODAY ON RESEARCH TO IMPROVE TREATMENTS FOR OPIOID MISUSE AND ADDICTION AND TOMORROW WE'LL FOCUS ON RESEARCH TO ENHANCE PAIN MANAGEMENT. I KNOW AT OUR PREVIOUS MEETING YOU EMPHASIZED IT'S HARD TO SEPARATE THE AREAS INTO NEAT CATEGORIES FEEL FREE TO REMIND US OF THE WAY THE OVERALL AREAS OF FOCUS AND HOW EACH PROGRAMS CAN BE ARTICULATED AS WE PRESENT THEM TODAY BUT TODAY WE'LL FOCUS MORE ON THE AREA OF OPIOID MISUSE AND ADDICTION. WE'LL START WITH AN OPEN SESSION. WE'RE IN OPEN SESSION NOW. YOU'LL HEAR AFTER THE INTRODUCTION TWO PRESENTATIONS ON RESEARCH PROGRAMS THAT HAVE GOTTEN OFF TO A STRONG START AND UNDERWAY ALREADY AT THIS POINT IN THE FISCAL YEAR. THAT INCLUDES THE JUSTICE AND COMMUNITY INNOVATION NETWORK AND YOU'LL HEAR FROM DR. VOLKOW AND WILEY AND HEAR FROM DR. KROSHETZ AND DR. BARBARA KARP. ONCE WE HAVE THE OVERVIEWS AND WE'LL HAVE TIME FOR DISCUSSION, THAT'S WHEN WE'LL CLOSE THE MEETING. ALL THE NIH STAFF ARE ALLOWED TO STAY AND THE FEDERAL EMPLOYEES WILL STAY AND MEMBERS OF THE PUBLIC WILL START TO LEAVE AND WE'LL START WITH AN OVERVIEW AND EVERYONE IS ALLOWED TO BE PRESENT FOR THE OVERVIEW AND AFTER THE OVERVIEW WE'LL MOVE INTO A DISCUSSION THAT INCLUDES SOME SPECIFIC APPLICATIONS. AT THAT POINT FOR THE DISCUSSION WE ASK IF YOU SUBMITTED AN APPLICATION OR FOR ANY OTHER REASON OR THERE'S POTENTIAL PERCEIVED CONFLICTS YOU RECUSE YOURSELF FROM THE ROOM AND WE'LL HELP YOU REMEMBER WHETHER OR NOT YOU MAY BE IN PERCEIVED CONFLICTS FOR THE MANY PROGRAMS WE'LL GET TO TODAY. WE'LL START WITH THE OVERVIEW OF THE NAIDA CLINICAL TRIALS AND WE'LL DISCUSS COLLABORATIVE CARE FOR THOSE INDIVIDUALS WITH MENTAL HEALTH CONDITIONS AND WE'LL HAVE THE NATIONAL INSTITUTE OF MENTAL HEALTH TO LEAD THAT DISCUSSION. THEN WE'LL DISCUSS RESEARCH TO PREVENT OPIOID USE DISORDER AMONG AT RISK ADOLESCENTS AND YOUNG ADULTS FROM THE NATIONAL INSTITUTE ON DRUG ABUSE. WE'LL THEN SHIFT GEARS A LITTLE BIT AND INVESTIGATE SOME OF OUR RESEARCH TO ENHANCE OUTCOMES FOR INFANTS BORN EXPOSED TO OPIOIDS WITH PRESENTATIONS FROM THE NATIONAL IN THE OF HUMAN DEVELOPMENT AND THE NATIONAL INSTITUTE ON DRUG ABUSE. THAT'S DAY ONE. TOMORROW WE'LL MOVE INTO THE MORE PAIN FOCUSSED RESEARCH PROGRAMS AND DISCUSS THEM IN MORE DETAIL. IMPORTANTLY WHAT WE'RE SEEKING FOR YOU FROM YOU IS A SENSE OF YOUR ENTHUSIASM FOR THE DIFFERENT PROGRAMS, A SENSE OF WHAT YOU THINK IS REALLY REALLY IMPORTANT FOR THE HEAL INITIATIVE TO TAKE ON WHERE WE MIGHT HAVE MISSED OPPORTUNITIES TO MAKE OPPORTUNITIES OR BUILD IN AREAS OF SCIENTIFIC AREA OR AREAS OF PUBLIC HEALTH NEED. THIS CAN BE AN INTEGRATIVE PROCESS. AS WE DISCUSS APPLICATIONS YOU CAN ASK QUESTIONS AND WE CAN FRAME THE PRESENTATIONS GOING FORWARD TO YOU IN A WAY THAT GETS YOUR INPUT. I KNOW THERE WERE A LOT OF TERMS PRESENTED AND A LOT TO TAKE ON TODAY. SO THAT IS MY INTRODUCTION TO THE AGENDA. I HAVE A FEW GENERAL PROGRAM ATTIC ANNOUNCEMENTS ABOUT THE HEAL INITIATIVE FIRST. I'M PLEASED TO ANNOUNCE WE HAVE PUBLISHED OUR POLICY FOR PUBLIC ACCESS AND DATA SHARING FOR RESEARCH GENERATED THROUGH THE HEAL INITIATIVE. AS YOU WILL REMEMBER, THE POLICY SEEKS TO MAXIMIZE THE AVAILABILITY OF PUBLICATIONS AND RESEARCH DATA GENERATED THROUGH THE HEAL INITIATIVE BECAUSE WE'RE FACING A PUBLIC HEALTH EMERGENCY AND BECAUSE WE'RE MAKING THE RESEARCH SOLUTIONS AVAILABLE TO THE BROADEST POSSIBLE AUDIENCE WE WANT THE OUTCOMES OF OUR HEAL RESEARCH TO BE ACCESSIBLE TO THE PUBLIC. FOR A NUMBER OF LARGE-SCALE HELA AWARDS AND WHERE THERE'S A ROLE PUBLICATIONS AN UNDERLYING DATA WILL BE MADE AVAILABLE TO THE PUBLIC AT THE TIME OF PUBLICATION AND WE'LL MAKE SURE EACH OF THE PROGRAMS HAS A SUBSTANTIAL DATA SHARING PLAN SO RESEARCHERS CAN ASK THEIR OWN SCIENTIFIC QUESTIONS AND COME UP WITH THEIR OWN SCIENTIFIC SOLUTIONS BASED ON WHAT WE GENERATED AND THE POLICY IS POSTED ON THE HEAL WEBSITE. THANK YOU TO,000 ON THE WORK -- THOSE ON THE WORKING GROUP WHO PUSHED US IN THIS DIRECTION. IT WAS A GREAT SUGGESTION AND WILL HELP MAXIMIZE THE VALUE OF THE HEAL INITIATIVE. TO THAT END, I ALSO HAVE A VERY BRIEF CONCEPT CLEARANCE FOR THE HEAL INITIATIVE. WE ARE PROPOSING AN ADDITIONAL ACTIVITY AND BRINGING IT TO YOUR ATTENTION FOCUSSED ON GENERATING AN OVERARCHING DATA COORDINATION AND RESEARCH CENTER. THE CENTER WOULD PROVIDE THE PROGRAM WITH CENTRALIZED CORDINATION, MANAGEMENT AND SUPPORT A CLOUD-BASED INFRASTRUCTURE THROUGH THE HE'LL INITIATIVE. I GAVE A BRIEF PRESENTATION AND SO DID DR. TABAK AT THE LAST MEETING OPERATIONALIZING IT AND WORK THE RESEARCH COMMUNITY TO PUT INTO PLACE A RESOURCE TO SUPPORT ALL THE DATA GENERATING RESEARCH INVESTIGATORS AND ALSO ESTABLISH SOME COMMON DATA ELEMENTS AND STANDARDS AND METRICS AND ESSENTIAL RESOURCE FOR THE DISCOVERY OF HEAL PROGRAMS AND CURATE A LEADERSHIP ROLL ACROSS THE PROGRAMS TO MAKE SURE THE DATA COULD BE COMPARED AND RESEARCH ACROSS. WE EXPECT THIS WILL HAVE A SIGNIFICANT ONGOING CONTRIBUTION FROM NIH STAFF. THAT IS MY GENERAL OVERVIEW. ARE THERE ANY QUESTIONS ABOUT HOW WE SHOULD OR HOW WE WILL CARRY OUT TODAY'S DISCUSSION ESPECIALLY WITH REGARD TO THE OPEN AND CLOSED SESSIONS AND DISCUSSION OF INDIVIDUAL PROGRAMS? WELL, I'M AVAILABLE TO ANSWER ANY QUESTIONS IF YOU'RE NOT SURE WHETHER YOU'RE IN CONFLICT OR WANT TO TALK THROUGH AN ISSUE, PLEASE FEEL FREE TO FIND ME AND WE'LL DISCUSS OFFLINE. SO WITH THAT, I'M VERY PLEASED TO MOVE INTO THE FIRST PRESENTATION OF OUR OPEN SESSION. DR. VOL KOW WOULD YOU INTRODUCE THE TOPIC. >> THANK YOU, REBECCA AND FRANCIS AND LARRY FOR THE LEADERSHIP THAT YOU HAVE ALL EXERTED ON THE HEAL INITIATIVE AND WE'RE THE NATIONAL INSTITUTE OF DRUG ABUSE AND OUR TASK IS TO TREAT AND PREVENT SUBSTANCE USE DISORDERS AND IT DEMANDS WE RECOGNIZE ALL THOSE INTERVENTIONS MORE LIKELY TO DECREASE THE NUMBER OF PEOPLE THAT DIE FROM OVERDOSES. AND WHEN I THINK OF THE OPIOID CRISIS IT'S CLEAR IN MY BRAIN WE HAVE VERY POWERFUL TOOLS IF WE USE IT WE SHOULD BE ABLE TO SIGNIFICANTLY REDUCE THE NUMBER OF PEOPLE THAT ACCOMMODATE AND DIE FROM THEIR OPIOID ADDICTION. SO ONE OF THE BIG CHALLENGES THAT WE'VE HAD IS WHILE THE EVIDENCE IS THERE ABOUT ALL THE INTERVENTIONS, THEY ARE NOT BE PROPERLY IMPLEMENTED ON THE ONE HAND. AND THE LACK OF IMPLEMENTATION REFLECTS TWO FACTORS. ONE IS STIGMA AND LACK OF UNDERSTANDING OF THE PROCESS AND THE OTHER RELATE TO THE LACK OF INFRASTRUCTURE. WE KNOW FOR EXAMPLE OF THE MOST POWERFUL TOOLS WE HAVE ARE MEDICATIONS. IT'S LIKE ALL STANDARD AND YOU CAN PREVENT PEOPLE DYING FROM OVERDOSES. YOU CAN PROVIDE THE MEDICATION FOR OVERDOSE DISORDERS AND THE CHALLENGES ARE NUMBER ONE, GETTING PEOPLE ACCESS TO THOSE TREATMENTS BECAUSE A SIGNIFICANT NUMBER OF INDIVIDUALS ARE NOT GIVEN THESE MEDICATIONS. AND THERE IS STIGMA AROUND IT AROUND THE MEDICATIONS BUT VERY IMPORTANTLY THERE IS LOOK OF INFRASTRUCTURE AND THE LACK OF INFRASTRUCTURE REFLECTS ON THE ONE HAND THE FACT THAT AGAIN UNDER THE HEALTH CARE SYSTEM ADDICTION HAS NOT BEEN RECOGNIZED ON THE PART OF RESPONSIBILITY OF DOCTORS AND NURSES AND THEREFORE NOT EVEN TRAINED. AS A NATION, WE HAVE CRIMINALIZED ADDICTION. A SIGNIFICANT NUMBER OF PEOPLE WITH OPIOID USE DISORDERS END UP IN THE JUSTICE SETTINGS AND WE'RE THE NATION WITH THE LARGEST NUMBER OF PEOPLE INCARCERATED. AND A SIGNIFICANT PORTION OF THEM HAVE A SUBSTANCE USE DISORDER. THE LATEST STATISTICS WE HAVE IS IN 209 WHERE IT WAS ESTIMATED 20% OF INDIVIDUALS HAVE SUBSTANCE USE DISORDERS THAT DID NOT INVOLVE ALCOHOL. IF YOU INVOLVE ALCOHOL IT GOES WAY UP. THAT WAS 2007 TO 2009. NOW THE NUMBERS INDICATE THAT PERHAPS PERHAPS 60% TO 70% OF PEOPLE IN JAIL CELL PRISONS MISUSED OPIOIDS AND THE DATA SHOWS WHEN YOU DON'T TREAT THESE INDIVIDUALS THE RISK OF DYING IS HIGH. DESPITE THE NUMBERS OF THE 5,000 JAILS AND PRISONS IN THE UNITED STATES, SOME PROVIDE TREATMENT FOR OPIOID USE DISORDERS. AS A RESULT OF THAT THE NUMBER OF INDIVIDUALS INCARCERATED ARE NOT GIVEN MEDICATION. WHAT CAN WE DO? IF WE WANT TO INCREASE THE NUMBER OF INDIVIDUALS RECEIVING MEDICATIONS ONE IS HEALTH CARE AND YOU'LL HEAR WHAT WE'RE DOING AND IS THE OTHER IS IN THE JUSTICE SETTING. TRADITIONALLY NIH DOES NOT WEIGH IN ON THE JUSTICE DEPARTMENT. IT'S A DIFFERENT CULTURE. WHAT WE'RE AIMING TO DO WITH THE HEAL INITIATIVE IS EXPAND THE CAPACITY THAT WE HAVE TO DO RESEARCH AND CREATE PARTNERSHIPS WITH A JUSTICE DEPARTMENTS, PRISONS AND JAILS. IT'S A COMPLEX STRUCTURE AND THERE'S DIFFERENCES ACROSS STATES AND INDIVIDUALS HAVE DIFFERENT LEVELS AND YOU CAN BE IN PRISON AND AN IMPORTANT COMPONENT HAS BEEN ALONG THERE'S BEEN A LOT NEGATIVE ATTITUDES TOWARDS THE USE OF MEDICATIONS IN PRISON SYSTEMS. THIS IS ONE OF THE REASONS WHY WE WERE PROACTIE IN HAVING DEVELOPMENT OF A NONTAGONIST TO TREAT OPIOID USE DISORDERS IN PRISON SETTINGS. THE PORTFOLIO YOU ARE GOING TO BE SEEING IN TERMS OF WHAT WE WANT TO DO REFLECTS THE NEED TO DEVELOP MODELS THAT COULD BE IMPLEMENTED AND SUSTAINED. THE NEED TO TAKE ADVANTAGE OF NEW TOOLS THAT HAVE EMERGED IN MEDICATION DEVELOPMENT THAT MAKE IT EASIER TO APPLY. THE NEED TO CREATE PARTNERSHIPS BETWEEN JUSTICE AND HEALTH SYSTEMS AND IMPORTANTLY THE NEED TO PROVIDE EVIDENCE ABOUT THE ECONOMIC SUSTAINABILITY OF SUCH EVIDENCE. WE'RE VERY LUCKY AT NIAIDA TO HAVE AN EXTRAORDINARY LEADER IN THIS AREA, TISHA WHO HAS NOT JUST DEVELOPED THE PROGRAM BUT EXPAND AND CREATED MEANINGFUL RELATIONSHIPS WITH THE DEPARTMENT OF JUSTICE. DR. TISHA WILEY WILL GIVE THE PERFORMAL PRESENTATION OF WHAT THE PROJECT -- THE FORMAL PRESENTATION OF WHAT THE PROGRAM LOOKS LIKE. >> DO I HAVE A CLICKER TO MOVE THE SLIDES? GOOD MORNING, EVERYONE. I'M EXCITED TO BE HERE AND SHARE WITH YOU WHAT WE'RE DOING IN OUR INITIATIVE. SO HERE'S WHAT DR. COLLINS REFERENCED. WE FOCUS ON IMPROVING TREATMENTS FOR MISUSE AND ADDICTION UNDER OPTIMIZED EFFECTIVE TREATMENTS. AND OTHER PROJECTS IN THE GROUPING AND WE'RE FOCUSSED ON INNOVATION IN THE JUSTICE SYSTEM. NORAH GAVE YOU BACKGROUNDS BUT HERE STATISTICS. IT'S A HUGE TOUCH POINT FOR PEOPLE WHO HAVE ADDICTION. BETWEEN 10 MILLION AND 11 MILLION ARE ARRESTED AND 2 MILLION ARE INCARCERATED AND THERE'S 6MAN AND -- 6 MILLION AND 7 MILLION UNDER THE SUPERVISION OF THE JUSTICE SYSTEM AND THEY'RE LESS LIKELY TO RECEIVE TREATMENTS FOR OPIOID USE DISORDER. IT'S NOT JUST ABOUT WHAT HAPPENS BEHIND BARS, 90% OF PEOPLE WILL RETURN TO THE COMMUNITY AND WHEN THEY DO THEY'RE AT A HEIGHTENED RISK FOR OVERDOSE AND MORTALITY WHEN THEY RETURN TO THE COMMUNITY. THAT CAN BE ATTENUATED. SOME SUGGEST AS MUCH AS 75% BY PROVIDING ACCESS TO MEDICATIONS DURING INCARCERATION AND RE-ENTRY PERIOD. AND THIS IS A RAPIDLY CHANGING LANDSCAPE. A FEW STATES HAVE PASSED LAWS THAT SAY MEDICATIONS HAVE TO BE OFFERED FOR THOSE INCARCERATED IN MAINE SAID WITH HOLDING MEDICATIONS SAY VIOLATION -- IS A VIOLATION WITH THE AMERICANS WITH DISABILITY ACT. WE'LL SHE YOU WHAT WE'RE -- SHOW YOU WHAT WE'RE DOING AND LESS THAN 1% OF THE NATION'S JAILS OFFER ANY FORMS OF MEDICATION. WE THINK IT WILL RAPIDLY CHANGE WITH THE COURT RULINGS AND LAWS BEING PASSED AT THE STATE LEVEL. WE HOPE WE CAN MOVE TOWARDS A MISSION WHERE VERY INDIVIDUAL INVOLVED IN THE JUSTICE SYSTEM WHO HAS A SUBSTANCE USE DISORDER HAS ACCESS TO TREATMENT. SO FOR PEOPLE WHO HAVE AN OPIOID USE DISORDER THAT MEANS HAVING ACCESS TO ALL FORMS OF FDA APPROVED MEDICATIONS. HERE'S SOME OF OUR PRIORITY GOALS AS WE MOVE TO THE VISION. WE KNOW WE HAVE TO GENERATE NEW EVIDENCE FOR WHAT WORKS AND TAKE WHAT WORKS AND PUT THEM INTO PRACTICE. WE HOPE TO BECOME A GO-TO RESEARCH AS WE WORK TOWARDS THE GOAL. WE'LL BE BUILDING A NETWORK THAT IS ABOUT RESEARCHERS COLLABORATING WITH PRACTITIONERS AND THE JUDGE, SHERIFFS, PROBATION OFFICERS TOUCHING THE PEOPLE ON A DAILY BASIS AND COMMUNITY-BASED SERVICE PROVIDERS PROVIDING SERVICES TO THOSE FOLKS. THAT MEANS THERE HAS TO BE A DIALOGUE BETWEEN THE RESEARCHERS AD PRACTITIONERS. THAT'S WHAT WE'RE MOVING TOWARDS AND HOPE TO BUILD CAPACITY FOR RESEARCHERS THAT CONDUCT THIS KIND OF RESEARCH. IT'S COMPLEX RESEARCH AND THERE'S A LOT OF ADDITIONAL REGULATORY OVERSIGHT REQUIRED AND FOR PRACTITIONERS IN THE FIELD BUILD THEIR CAPACITY TO CONDUCT STUDIES IN THEIR OWN SETTINGS SO MEET THEIR NEEDS. WE HOPE THAT WILL LEAD TO THE TRANSLATION PROCESS AND FEEDBACK LOOPS. I'M EXCITED TO ANNOUNCE WE'VE BEEN ABLE TO FINALIZE THE INFORMATION WITH THE BUREAU OF JUSTICE SYSTEMS PART OF THE DEPARTMENT OF JUSTICE. AND THEY'RE LOCAL INITIATIVES THAT PROVIDE THOSE INJUSTICE SETTINGS AND MOVE CLOSER TO THAT GOAL. THERE ARE TWO COMPONENTS. LET ME GIVE YOU A QUICK OVERVIEW. THERE'S STUDIES ON THE LEFT AND SUPPORTIVE INFRASTRUCTURE I'LL START WITH THE STUDIES. EARLIER IN 2018 AT THE END OF THE PHYSICAL 2018, WE WERE ABLE TO SERVE TO ACCELERATE THE WORK WE'RE ABLE TO DO WITH THIS. WE FUNDED 20 PROJECTS AND I'LL SHOW YOU DETAIL IN A MOMENT. THE BIGGEST COMPONENT COMES FROM MY RESEARCH. EACH WERE BETWEEN THE 15th OF JULY AND 23rd AND EACH STUDIES ARE MULTI-STATE STUDIES. EACH TAKES PLACE IN AT LEAST FIVE COMMUNITIES. THERE'S A CASCADE OF CARE AND ORGANIZING FRAMEWORK. EACH HAS HAD A JUSTICE AND TREATMENT PARTNER TO THE TABLE TO HELP THINK THROUGH AND DESIGN APPLICATIONS INTO THE STUDY FROM THE BEGINNING. AND THERE ARE TWO MAIN COMPONENTS. THE COORDINATION AND TRANSLATION CENTER FOR SCIENCE AND OUTREACH. ONE CENTER WAS FUNDED IN JUNE. THE OTHER COMPONENT IS THE METHODOLOGY TO PROVIDE THE DATA INFRASTRUCTURE AND THAT WE'LL SHOW YOU MORE DETAILS IN A MOMENT. JUST TO GIVE YOU MORE I'LL START WITH THE ACCELERATORS AND SHOW YOU HIGHLIGHTS FROM THOSE. THEN I'LL SHOW HIGHLIGHTS FROM THE RESEARCH PROJECTS INCLUDING THE RESEARCH HUBS. INCLUDING THE OUTREACH AND THEMES THAT CONNECT THEM AND THE CORE DOMAINS OF MEASUREMENT pGIVE MORE DETAIL OF THE CAPACITY BUILDING AND INFRASTRUCTURE WE HAVE BAKED IN AND THE STRUCTURAL COMPONENTS AND THERE'S THE TRANSLATION AND COORDINATION CENTER AND THE MARK IS THE METH METHODOLOGY CENTER. IN TERMS OF THE ACCELERATORS ABOUT A YEAR AND A HALF AGO I WAS ASKED HOW MANY JAILS OFFER MEDICATIONS AND I STARTED TRYING TO FIND THE ANSWER. SURELY THERE'S DATA TO FIND THE ANSWER TO THAT, THERE IS NOT. THERE'S A STATISTIC RECENTLY CITED END NEWSPAPER ARTICLES BUT WHEN YOU WENT TO THE SOURCE IT WAS SOMEONE'S SPREAD SHEET TRACKING NEWS STORIES. SO THERE'S NO DATA AND WE'RE FIELDING IT AND WE'RE CURRENTLY FIELDING A SURVEY AND THERE'S 245 JAILS WE'LL BE SURVEYING. WE WORKED HARD TO GET BUY-IN FROM STAKEHOLDERS. THE NATIONAL SHERIFF'S ASSOCIATION AND JAIL ASSOCIATION HAVE SENT OUT NEWSLETTERS TO THEIR CONSTITUENTS TO ENCOURAGE THEM TO PARTICIPATE WHEN CONTACTED. WE'RE WORKING WITH IN-STATE JAILS AND PLACES WHERE WE DON'T KNOW WHAT'S HAPPENING LIKE DRUG COURTS AND SURVEYING THE VA AND WE'RE LOOKING AT WHAT HAPPENS IN THE VA AROUND THAT AS WELL. THOSE ARE IN THE FIELD AND WE EXPECT RESULTS IN THE NEXT SIX MONTHS OR SO. AND WE BUILT ON SOME OF NIAIDA EXISTING INFRASTRUCTURE. HERE'S TWO EXAMPLES. THE NATIONAL DRUG WARNING SYSTEM. IT DOES SURVEILLANCE OF DRUG TRENDS AND AN ACTIVE USER FORUM AND WE HAVE A FORUM OF ACTIVE JUSTICE AND A PLACE FOR PEOPLE TO TALK WITH THE ISSUES. WE SUPPLEMENTED THE EPIDEMIOLOGY AND WHAT PRACTICES ARE NATIONWIDE AROUND VARIOUS LAWS. AND THERE'S A WEBSITE WHERE THEY DO PRESCRIPTION DRUG ABUSE SURVEILLANCE. AND WE HAVE DATA SETS AVAILABLE TO THE PUBLIC WHERE THEY HAVE IDENTIFIED WHAT THE CURRENT STATE OF LAWS ARE AND THESE AREAS OF DRUG-INDUCED HOMICIDE AND UNVOLUNTARY COMMITMENT AND IN SOME STATES MEDICAID IS TURNED OFF FROM PEOPLE GOING TO JAIL WHICH MEANS IT'S HARDER FOR THEM TO GET ACCESS TO MEDICAID WHEN THEY RETURN TO THE COMMUNITY AND ACCESS TO SERVICES THAT CAN BE PAID FOR BY MEDICAID AND MEDICAID IS PAUSED AND IT MAKES THE TRANSITION SMOOTHER. WE HAVE THAT DATA SET AND COVERAGE OF MEDICATIONS BY MEDICAID. THOSE WILL BE UP ON THE WEBSITE WITHIN THE NEXT MONTH AVAILABLE FOR DOWNLOAD. AND BACK IN BJORK OF LAST YEAR WE -- IN OCTOBER OF LAST YEAR WE FUNDED A HACKATHON. THE HACKATHON HAD TEAMS LOOKING AT HOW YOU COMBINE PUBLIC HEALTH AND DATA SETS AND WITH THE HACKATHON IS TYPICALLY WHERE IT STOPS AND WE LOOKED IF IT COULD TURN INTO AN IMPLEMENTATION STRATEGY AND PARTNERED WITH SCIENTISTS TO GO TO COMMUNITIES WHERE RELEVANT DATA SETS WERE FOUND AND LOOKED TO SEE IF THEY COULD APPLY THOSE FROM THE HACKATHON SOLUTIONS. AND WHAT WE WERE ABLE TO DO IS HAD A JCOIN MEASUREMENT PLAN MEETING AND IT WAS LESS THAN TWO TO THREE WEEKS WE ISSUED THE AWARDS AND WE BROUGHT IN AWARDEES AND LOOK AT KEY DOMAINS OF MEASUREMENT QUICKER THAN WITHOUT THE SUPPLEMENT AND I'LL GIVE MORE DETAIL WHAT THE MEASURES ARE IN A MOMENT. WE HAD 68 PEOPLE AT THAT MEETING. SO RETURNING TO THE HUBS THIS IS TO GIVE YOU A GEOGRAPHIC DEPICTION. WE HAVE 52 COMMUNITIES AND WE CROSSED 16 STATES AND TERRITORIES AND AND WE EXPECT TO TOUCH MORE THAN 16,000 PATIENTS THROUGH THE STUDIES. WHAT ARE THE STUDIES? HERE'S AN OVERVIEW. THIS IS PCOMPLICATED SO I'LL ORIENT YOU. EACH BOX SHOWS AT THE TOP THE ORGANIZATION THAT WAS FUNDED AND PARENTHETICALLY NOT THE STATE THE ORGANIZATION IS IN BUT THE STATE THE STUDY WILL BE EXECUTED IN. BELOW THAT YOU HAVE A BRIEF DESCRIPTION OF THE STUDY IN IS THE BARS BELOW SHOW YOU THE STUDY AND WHAT WILL TAKE PLACE. WE HAVE SEVEN STUDIES IN JAIL STUDIES. AND NEXT TO THAT IS HOW MANY OF THOSE. WE HAVE SEVEN STUDIES TAKING PLACE IN GENERAL. FIVE TO 10 JAILS PER STUDY AND DRUG COURTS AND THEN PROBATION AND PAROLE AND STUDIES FOCUSSED ON PROBATION AND PAROLE. THE BLUE ACCESS AND THE LEFT IS FOCUSSED ON STATE/LEVEL POLICY ROLES. WHAT'S EXCITING -- THIS IS A DYNAMIC ENVIRONMENT AND WE'LL STUDY TWO STATES ON THE LEADING EDGE OF THIS. IN MASSACHUSETTS THEY PASSED A LAW THAT MANDATED SEVEN JAILS HAD TO PILOT USING ALL THREE FORMS OF MEDICATIONS IN THE JAILS. WE'LL STUDYING THAT AS THE POLICY ROLLS OUT AND GETS INTO PLACE. MARYLAND IN THE LAST MONTH OR SO PASSED A SIMILAR LAW AND WE HAVE A STUDY SO WE'LL HAVE A CHANCE TO MAKE SOME CONNECTIONS ACROSS THOSE AS WELL. IN NEW YORK THERE WAS A MODIFICATION OF A DRUG PORT MODEL. THEY PLAN TO MOVE THAT INTO 10 COMMUNITIES IN NEW YORK AND WE'LL HAVE THE CHANCE TO VIEW THAT. WE HAVE CASE MANAGEMENT AND HOW YOU THINK WITH THE SERVICES PEOPLE GET AND HELPING PEOPLE NAVIGATE THROUGH THE SERVICE SYSTEM. ON THE BOTTOM THEY HAVE AN A CLIENT LEVEL INTERVENTION AND FOCUS ON THE DYNAMICS AND HOW TO LOOK AT HOW THEY'RE ABLE TO ADAPT EFFECTIVE PRACTICES AND ON THE RIGHT WE HAVE TWO FOCUSSED ON COMPARATIVE EFFECTIVENESS OF MEDICATIONS. WHY IS THAT IMPORTANT? SO ONE OF THE REASONS WHY JUSTICE SYSTEMS HAVE BEEN SLOW TO ADAPT TO MEDICATIONS IS AROUND CONCERNS FOR DIVERSION WHICH IS MAKING TREATMENT OF AN INJECTABLE FORMULATION WITH A LONG-ACTING FORMULATIONS SOME OF WHICH HAVE NOT BEEN TESTED INJUSTICE SETTINGS. WE HAVE ONE APPROVED A YEAR AND A HALF AGO IN LATE 2017 AND WE HAVE ANOTHER APPROVED BUT NOT YET READY FOR MARKET. WE'LL HAVE STUDIES BY SIX STATES AND ABOUT 1,000 PATIENTS WHERE WE'RE LOOKING AT THIS. THIS WILL BE A LARGE SCALE EFFECTIVENESS TRIAL. SO IS A MEETING FOR STUDIES. SO WE ARE CURRENTLY STUDYING DESIGNS THAT MAKE SENSE AND THESE ARE ORGANIZED FROM AN INDIVIDUAL LEVEL TO AN ORGANIZATIONAL LEVEL. WE HAVE MEASURES OF SUBSTANCE USE NOT ONLY INCLUDING OPIOIDS BUT OTHER SUBSTANCES AND OVERDOSE. I WANT TO HIGHLIGHT WE'RE COLLECTING THIS AT MULTIPLE LEVELS. WE'LL LOOK AT ADMINISTRATIVE AND BIOLOGICAL AND THE CASCADE OF CARE FOCUS AND OTHER INDIVIDUAL CHARACTERISTICS OF BROAD RANGE AND LOOK AT ASPECTS OF THE INTERVENTIONAL CHARACTERISTICS AND LOOK AT INTERVENTION STRATEGIES AND LOOK AT ECONOMIC MEASURES AND ONE OF THE EXCITING THINGS WHICH IS LOW HANGING FRUIT TO CAPITALIZE ON AND WE HAVE METHODOLOGIES WITH GEOSPATIAL STUDIES AND WE'LL LOOK AT THE DISTANCE BETWEEN HOW FAR THE PATIENT HAS TO TRAVEL AND LOOK AT SOME OF THOSE GEOSPATIAL ASPECTS THAT MAY BE HIDDEN MODERATORS OF TREATMENT OUTCOMES SO WE'RE EXCITED ABOUT THAT ABILITY. THIS TALKS MORE IN DETAIL ABOUT OUR CAPACITY BUILDING AND TRANSLATIONAL INFRASTRUCTURE. SO THOSE WILL TWO COMPONENT WE HAVE. AND THERE'S A SOPHISTICATED CAPACITY ON THE DATA COMMONS AND MANAGING DATA SETS AND BRINGING THEM TOGETHER. WHAT'S UNIQUE IS WE ALSO HAVE A SURVEY RESEARCH PIECE EMBEDDED. I MENTION THE EXAMPLES IN THE ACCELERATOR PROGRAM AND PLAN TO DO THAT ON AN ONGOING BASIS AND COLLECTING RESEARCH ON TARGETED OUTCOMES. WE PLAN TO REPEAT AND WE'LL HAVE CHANGES OVER TIME AND WHETHER FOR EXAMPLE THE SITES WE HAVE IN OUR NETWORK ARE ACTUALLY REFLECTIVE OF WHAT'S HAPPENING ON A NATIONAL MODEL. THE OTHER THING I THINK WILL ACCELERATE THE IMPACT OF THE NETWORK ARE OR MODE JELG -- MODELLING PROJECTS AND WE HAVE AGENT BASED MODELS AND PREDICTIVE ANALYTICS AND GEOSPATIAL APPROACHES AND WE'LL HAVE MODELLING PROJECTS GOING ON THROUGH THE BEGINNING OF THE STUDY EVERY YEAR AND WILL ADD CAPACITY TO INCREASE THE IMPACT OF SOME OF OUR STUDIES FOR EXAMPLE MODELLING POTENTIAL OUTCOMES IN THE STUDY. WE'RE EXCITED TO LOOK AT THE POTENTIAL. FINALLY TO LOOK AT THE STAKEHOLDER BUY-IN COMPONENT AND THIS IS DIFFERENT. WE HAVE SOMETHING CALLED RAPID RESPONSE PILOT TRIALS. THERE'S A LOT OF INNOVATION HAPPENING IN THE FIELD. COMMUNITIES TRY IT AND FIND IT HARD TO GET THROUGH NIH FUNDING AND MAKE IT THROUGH OUR PROCESS. OFTEN BY THE TIME WE GET THEM FUNDING THE PROGRAM HAS ENDED AND WE EXPECT TO BE ABLE TO PUT FUNDS OUT FOR SMALL PROGRAMS SMALL PILOT PROJECTS TWO TO THREE TIMES A YEAR AND HOPING IT WILL GENERATE FRESH DATA AND NEW IDEAS AND WE THINK IT WILL BE EXCITING AND WE'LL EMBED A RESEARCH DESIGN IN A WAY TO PUSH THAT OUT TO THE COMMUNITY AND LEVERAGE IMPLEMENTATION SCIENCE AND ALL THE INSIGHTS IT CAN BRING. ONE THING I'M EXCITE ABOUT IS KEY STAKEHOLDER INPUT. pWE HAVE A ROBUST GROUP TO BRING TOGETHER AND USE THEM TO GENERATE INPUT AND ADVICE ABOUT WHAT TOPICS NEED TO BE EXPLORED AND HOW TO EXPLORE IT AND LOOK AT RESEARCH DESIGNS, OFFER ADVICE, SUGGEST TARGETED AREAS WE MIGHT WANT TO MAKE INVESTMENTS IN. WE'LL BUILD THAT NETWORK INTO THAT SO WE'RE CONNECTING THE RESEARCH IN PRACTICE FROM THE BEGINNING. FINALLY, WE'LL HAVE INFRASTRUCTURE AS WELL TO DO TRAINING FOR RESEARCHERS AND PRACTITIONERS. I KNOW I'VE GONE OVER A LOT. THAT'S ALL I HAVE AND HOPEFULLY GIVES YOU A GOOD SENSE HOW WE'LL STRUCTURE THE JCOIN NETWORK AND WHAT WE HOPE TO ACCOMPLISH. >> TERRIFIC, THANK YOU VERY MUCH. AND TO REMIND OUR MDWG THIS IS PART OF THE OPEN SESSION WHERE WE THOUGHT YOU'D WANT TO KNOW ABOUT PROGRAMS WE ALREADY WENT AHEAD AND GOT FUNDED BECAUSE OF THE URGENCY AND GOT COMPELLING INFORMATION AND THIS IS NOT TO WEIGH IN ON THE PROGRAMS BUT FOR YOUR INFORMATION AS CONTEXT BECAUSE IT'S A CRITICAL PART OF A LARGE AND COMPLICATED LANDSCAPE. IS THERE QUESTION OR COMMENTS PEOPLE WANT TO MAKE ABOUT WHAT YOU JUST HEARD ABOUT JCOIN WHICH IS AMBITIOUS AND A CRITICAL PART OF TRYING TO FIND SOLUTIONS BECAUSE WE KNOW WE LOSE AN AWFUL LOT OF OPPORTUNITIES BY NOT HAVING THE JUSTICE SYSTEM INVOLVED AND WE WANT TO CHANGE THAT. QUESTIONS, COMMENTS. >> WITH THE PILOT PROJECT IS THAT ANOTHER SERIES OF RFAs IN THE COMING YEARS OR HOW'S THAT WORK? >> THEY'LL ISSUE SOLICITATIONS. IT'S NOT THROUGH NIH MECHANISMS. WE HAVEN'T WORKED OUT ALL THE DETAILS. AND WE USE A CORE SO YOU CAN THINK IT AS A PILOT CORE BUT HAS TO BE OPEN TO THE WHOLE COMMUNITY. IT'S NOT JUST OPEN TO JUST THE JCOIN NETWORK BUT RESEARCHERS AND PRACTITIONERS. WE HOPE TO MAKE IT EASIER TO GET IN AND GET FUNDS FOR A SMALL AREA AND HOPE THIS WILL BE A WAY TO DRAW IN COMMUNITIES DEGREE INNOVATIVE -- DOING INNOVATIVE THINGS BUT DIDN'T HAVE A RESEARCHER TO PARTNER WITH AND HOPE TO CONNECT THE DOTS THROUGH THAT. WE HOPE TO STAND THAT UP IN THE FIRST QUARTER OF 2020. IT WILL BE ON THE WEBSITE. WE'LL FIGURE OUT THE WAYS TO ADVERTISE IT BUT WON'T DO THROUGH THE TYPICAL NIH PEER REVIEW PROCESS. THAT IS WHAT THE FLEXIBILITY ALLOWS IT TO BE VERY RAPID. THE AWARDS WILL BE RELATIVELY SMALL AND SO THERE'S A BUNCH OF CRITERIA TO MAKE SURE THEY'RE SMALL PILOT PROJECTS. >> I THINK WHAT YOU'RE DOING IS FANTASTIC. I'M EXCITED TO SEE THIS. >> I'M NOT SURE WE CAN QUITE HEAR. >> I THINK IT'S FANTASTIC. ONE QUESTION IN THE JAILS AND PRISONS I'VE TALKED TO IS DIVERSIONS. HOW ARE YOU HANDLING THAT BECAUSE I THINK IT'S GOOD FEEDBACK FOR THE JAILS AND PRISONS TO KNOW AND THE SECOND THING I HAVE TO ASK ABOUT IS SEX AS A BIOLOGICAL VARIABLE. WE KNOW IN MALE AND FEMALE PRISONS IF YOU CAN TALK ABOUT HOW YOU ARE ADDRESSING THAT AND WOMEN INCARCERATED SOMETIMES BECOME PREGNANT. CAN YOU TALK ABOUT THAT. THANK YOU. >> SO FIRST, CONCERNS ABOUT DIVERSION, I THINK IT'S A GREAT POINT. I MADE A NOTE AND WILL TAKE IT TO OUR MEASUREMENT PLANNING AND I WOULD PUT THAT IN THE ORGANIZATIONAL CLIMATE. I'LL MAKE SURE WE GET THAT IN THERE BECAUSE IT'S A GREAT POINT. THEN YOU TALKED ABOUT WOMEN AND SO WE WILL OBVIOUSLY LOOK AT COMPARATIVE EFFECTIVENESS TRIALS PLANNED TO SAMPLE FOR WOMEN AND THERE'S ONE PROJECT AT THE UNIVERSITY OF KENTUCKY HAS A PROJECT FOCUSSED ONLY ON WOMEN AND IT INCLUDES A TELEHEALTH COMPONENT. I THINK THAT'S ALSO AS WE THINK ABOUT FROM A MEASUREMENT PERSPECTIVE AND MAKING SURE WE HARMONIZE OUR MEASUREMENTS AND LOOK AT ISSUES THAT MIGHT OTHERWISE BE HARD TO DO FOR WOMEN BECAUSE THEY'RE TYPICALLY UNDER SAMPLED SO THAT'S A GREAT POINT AND WE'LL LOOK AT THE PROTOCOLS AND WE WILL LOOK AT THE BALANCE OF WOMEN AND RECRUITING SUFFICIENT NUMBERS OF WOMEN. YOU ASKED ABOUT PREGNANCY. WE HAVEN'T DESIGNED THAT IN TO ANYTHING. I KNOW IT TOUCHES ON OTHER PROJECTS YOU'LL HEAR ABOUT WITH THE HEALTHY BRAIN AND COGNITIVE DEVELOPMENT STUDIES BECAUSE A LOT OF THOSE WOMEN AND THE CHILDREN EXPOSED AND ALSO MY BA BACKGROUND IS DOING WORK IN THE CHILD WELFARE FIELD. I WAS HOPING WE'D GET SOMETHING IN HERE BUT ALL THE COMPLEXITY FOR WOMEN WHETHER THERE'S CHILD WELFARE INVOLVED OR IN JAIL AND WHAT THAT LOOKS LIKE. I HOPE WE CAN IDENTIFY OPPORTUNITIES TO EXPLORE THAT. WE HAVE A GREAT PLACE TO START WITH IDEAS FOR THAT. >> THANK YOU VERY MUCH. I WANTED TO TALK ABOUT THE PRACTITIONER/RESEARCHER PARTNERSHIPS. THE SCIENCE EXISTS BUT IF THE DOOR'S CLOSED WE DON'T GET FURTHER WHAT STRATEGY THE PROJECTS USING AND HOW ARE YOU ENSURING IT'S HAPPENING? >> WE HAVE THREE WAYS BUILT IN AT DIFFERENT LEVELS. AT THE LEVEL OF THE INDIVIDUAL STUDY THERE'S FIVE COMMUNITIES EVERYONE PROPOSED TO WORK IN THEY HAD TO HAVE LETTERS OF SUPPORT FROM A JUSTICE STAKEHOLDER AND THE COMMUNITY STAKEHOLDER. WE KNOW THEY AT LEAST HAVE THOSE TWO SYSTEMS AT THE TABLE IN WHATEVER THEY'RE TRYING TO DO. WE HOPE BY STARTING THERE AND MAKING SURE BOTH PERSPECTIVES ARE IN PLACE AT THE LEVEL OF THE SITES THAT WILL HELP AND THE NEXT STEP UP AT EACH OF THE HUB AWARDS WE HAVE KEY PERSONNEL. SOMEONE THAT REPRESENTED THE JUSTICE PERSPECTIVE AND THE BEHAVIORAL HEALTH PERSPECTIVE. WE'LL TREAT THOSE FOLKS AS MEMBERS OF OUR STEERING COMMITTEE. WHEN WE MAKE DECISIONS AND DELIBERATE IT WILL BE THE PERSPECTIVES OF THE STAKEHOLDER SIDE AND THE THIRD WAY IS THE STAKEHOLDER CORE. THERE'S A FOCUS OF THE STAKEHOLDER CORE AND WE HAVE GENERATED A LIST AND WE ARE PLANNING OUR FIRST MEETING TO PRESENT INFORMATION FROM THE NETWORK ABOUT WHAT WE PLAN TO DO AND GET THEIR FEEDBACK ON WHAT PRIORITIES MIGHT BE AND FIGURE OUT HOW TO USE THEM TO DISSEMINATE WORK OUT. AND ANOTHER WAY WE HAVE BUILT INTO OUR EDUCATION CORE AND TRAINING FOR RESEARCHERS AND STAKEHOLDERS. AS WE HAVE FINDINGS WE'LL SYSTEMATICALLY BE PRESENTING THE FINDINGS AND THAT WILL BE JUST AS IMPORTANT. WE'LL BE FOCUSSED ON PUBLICATIONS AND TRADE JOURNALS IN ADDITION TO THE STANDARD NIH PEER REVIEWED JOURNALS. I HOPE TO CREATE A DIALOGUE BACK AND FORTH BETWEEN THE PERSPECTIVES. >> WE CAN TAKE ONE MORE QUESTION. ED. >> IT'S AN EXCITING INITIATIVE. MY QUESTION IS THERE'S A LOT OF MENTAL HEALTH COMORBIDITY, DEPRESSION, PTSD AND IMPULSE CONTROL PROBLEMS, IS THAT GOING TO BE A FOCUS? >> IT WILL BE EMBEDDED. WHEN WE HAVE OUR MEETING WE DID AN EXERCISE FOR ALL THE THINGS THAT WERE INDIVIDUAL THAT WEREN'T SUBSTANCE USE OR CRIMINAL JUSTICE INVOLVEMENT AND WHAT FLOATED TO THE TOP WAS MENTAL HEALTH CONSIDERATION. BEVERY -- WE HAVE TO FIGURE OUT HOW LONG THE ASSESSMENTS WILL BE AND WHAT THE MEASUREMENT TOOL WILL BE TO MAKE THAT POSSIBLE, WE'LL FIGURE OUT AND WE'VE REACHED OUT TO OUR COLLEAGUES AT NIH AND LOOKED AT OPPORTUNITIES TO PARTNER AND BUILD ON THAT AS WELL. I'LL REACH OUT TO COLLEAGUES TO LEARN FROM THAT AS WELL. >> BRIEFLY >> I WANT TO LOOK AT INNOVATIVE THINGS GOING ON IN THE CLINICS. I THINK THEY'RE IN THE SYSTEMS. WE WANT TO KEEP THAT GOING BECAUSE I THINK THAT'S WHERE THERE'S INNOVATIVE THINGS WHETHER IT HAS TO DO WITH DIVERSION OR WHATEVER WILL HAPPEN. AND BUILD IN THOSE AND TAKING NOTE IS IMPORTANT. >> WELL TAKEN. I CAN TELL IT'S A CRITICAL PART OF WHAT WE'RE TRYING TO ACCOMPLISH. WE HAVE THE EPIC NET EFFORT AND BARBARA KARP WILL MAKE A PRESENTATION. WALTER KOROSHETZ. >> I WANT TO SWITCH GEARS AND TALK ABOUT A PIECE OF THE PAIN PORTFOLIO OF HE'LL AND BASICALLY TALK ABOUT THREE -- HEAL AND BASICALLY TALK ABOUT THREE PLATFORMS TO DEVELOP THE NOVEL PAIN THERAPEUTICS TO TRY TO REDUCE THE DEPENDENCY OF PAIN PATIENTS ON OPIOIDS AND CREATE MORE EFFECTIVE TREATMENTS FOR PATIENTS WITH PAIN. BECAUSE AS IS EVIDENT FROM WHAT WE'RE TRYING TO DO HERE, WE NEED TO DO THIS WITH INDUSTRIES INVOLVEMENT BOTH ON A DEVICE AND DRUG SIDE. THE IDEA IS TO DEVELOP TREATMENTS THAT WILL EVENTUALLY BE COMMERCIALIZED AND GET ON TO THE MARKET. SO WE HAVE A HEAL PARTNERSHIP COMMITTEE WHICH MET IN AUGUST 1, 2019. THEY'VE BEEN HELPING US ALL pTHERE'S FOLKS ON THIS GROUP FROM ACADEMIA AND FROM THE DEVICE AND PHARMACEUTICAL INDUSTRY AND BIOTECHNOLOGY AND WE HAVE CROSS TALK FROM THAT COMMITTEE AND THIS COMMITTEE WITH MEMBERS OF BOTH COMMITTEES AND I'LL MENTION THAT DAN MELON FROM THE FDA FILLED IN AND WE HAVE A REPRESENTATIVE NOT ABLE TO MAKE IT FROM CDRH FOR DEVICES. THERE'S A LOT OF INTELLECTUAL POWER IF THE GROUP AND HELPFUL TO US. WHAT I'LL DO NOW IS GIVE A BRIEF OVERVIEW OF THE PAIN PROGRAM AND TALK ABOUT THE PRE-CLINICAL TESTING PLATFORM AND A PLATFORM WE'RE PUTTING TOGETHER FOR THE HEAL INITIATIVE. WE BEING MULTIPLE INSTITUTES AND I'LL TRY NOT TO BUTCHER THE PROGRAM AS I DESCRIBE IT BUT PLEASE INTERFERE IF I DO. IN TERMS OF THE HEAL INITIATIVE FOR PAIN AS SHOWN ON THE SLIDE, WE PUT PROGRAMS TOGETHER THAT SEEM TO COVER WE HOPE COVERS THE WHOLE SPECTRUM FROM DISCOVERY TO COMPARATIVE EFFECTIVENESS AND STUDIES THAT WILL EFFECT PRACTICE AND EVERYTHING IN BETWEEN. SO ON THE LEFT HAND WE HAVE A COMMON FUND PRATH WHICH IS LOOK -- PROJECT THAT MOVES SOME PEOPLE FROM AN ACUTE TO CHRONIC PAIN CONDITION. THE HOPE IS WE'LL DEVELOP BETTER MODES OF PREVENTING CHRONIC PAIN AND WE HAVE PROJECTS TO DISCOVER AND VALIDATE NOVEL TARGETS FOR PAIN AND THOSE IN WHICH THE CIRCUITS THEY'RE EFFECTING ARE DIFFERENT FROM THE REWARD CIRCUITS INTERTWINED WITH OPIOIDS AND CREATE ADDICTION. WE DO MORE THAN PUT OUT GRANTS FOR DISCOVERY BUT VALIDATE THE TARGETS TO SEE IF THEY HAVE LEGS. IS THERE TRACTION FOR THESE TO MOVE INTO THE THERAPY AND WE'LL TALK ABOUT THE PRE-CLINICAL SCREENING PLATFORMS AND WE ALSO HAVE PROGRAMS TO HELP INDUSTRY AND DEVICES TO MOVE THEM THROUGH THE STAGES THAT REQUIRE AN IDE FROM THE FDA TO GO INTO PATIENTS OR COVER PHASE 1 STUDIES WITH THE COMPOUNDS OR DEVICES. WE HAVE A SIMILAR PROGRAM FOR BIOMARKERS WE DO FOR DRUG DEVELOPMENT. AGAIN, IT'S NOT JUST DISCOVERY BUT TRYING TO VALIDATE THEM AND SEE HOW THEY CAN BE USEFUL. AND WHETHER THEY CAN BE MOVED INTO CLINICAL TRIALS PARTICULARLY FOCUSSED ON EARLY PHASE TRIALS AND END POINTS, BIOMARKERS OF TARGET ENGAGEMENT OR PROOF OF PRINCIPLE TO ENABLE GO, NO-GO DECISIONS AT THE PHASE 2 LEVEL. WE'LL TALK ABOUT THE NETWORK FOR TESTING NEW DEVICE OR DRUGS OR BIOMARKERS IN PAIN CONDITIONS AND DR. BARBARA KARP WILL TALK TO YOU ABOUT THAT. THIS IS A PAIN CONDITION AGNOSTIC NETWORK. IT SHOULD BE ABLE TO REACH OUT TO PAIN CONDITIONS DEPENDING ON WHAT THE ASSETS ARE BUT WE HAVE A COUPLE PROGRAMS SPECIFIC FOR PARTICULAR TYPES OF PAIN. BOB CARTER'S HERE AND THEY HAVE A PROGRAM TO UNDERSTAND BACK PAIN WHICH SAY -- IS A LEADING CAUSE OF PAIN AND UNDERSTANDING THE MECHANISMS AND WHAT WORKS FOR PATIENTS AND DEVELOP NEW AND NOVEL THERAPIES FOR BACK PAIN. WE HAVE A PROGRAM FROM NIDDK ON DIALYSIS MANAGEMENT OF PAIN IN PATIENTS UNDERGOING HEMODIALYSIS WHICH IS A SEVERE PROGRAM THAT AFFECTS THEIR ABILITY TO STAY ON DIALYSIS AND GET EFFECTIVE CONTROL OVER THEIR RENAL ABNORMALITIES. THERE'S A PAIN EFFECTIVENESS NETWORK THAT MANY OF THE I.C.s ARE INVOLVED IN AND NCATS AND NIAID ARE THE LEAD DOING COMPARATIVE EFFECTIVENESS RESEARCH AND WE'LL SEE SOME OF THOSE GRANTS AND THIS ONE WITH THE LAST ONE WHICH IS PRAGMATIC IMPLEMENTATION STUDIES ARE WE THINK KIND OF THE SHORTER TERM EFFECT ATTEMPTS TO GIVE INFORMATION TO PATIENTS AND DOCTORS TO HELP US MANAGE PAIN. THE LATTER IS ONE TO BE DONE IN HEALTH CARE SYSTEMS AND BOTH OF THEM ARE LOOKING AT THINGS LIKE DRUGS AND DEVICES BUT ALSO HEAVILY LOOKING AT THIS POINT AT NON-PHARMACOLOGIC MANAGEMENT OF PAIN AND THAT'S THE SPECTRUM OF WHAT WE'RE DOING IN THE PAIN SPACE. IN THE HEAL PARTNERSHIP INITIATIVE MEETING WE DISCUSSED THE PLATFORMS. THE FIRST ONE IS A PRE-CLINICAL SCREENING PLATFORM FOR PAIN AND THAT'S ANIMAL MODELS. THE DISCUSSION RESOLVED AROUND THINGS LIKE TRYING TO BE FLEXIBLE AND IN TERMS OF PUTTING TOGETHER THE MODELS USED TO TEST AN AGENT. THE IDEA IS YOU WANT THESE TO MATCH THE TARGET AND THE BIOLOGY THERE'S A QUOTE ALL MODELS ARE WRONG BUT SOME ARE USEFUL AND WE'RE TRYING TO FOCUS ON THE UTILITY OF THE MODELS AND TRY AND BUILD IN NEW MODELS TO FILL THE GAPS THAT HAVE STYMIED DEVELOPMENT OF NEW DRUGS FOR PAIN. WE THINK THERE'S A PREMIUM ON DOING THIS IN A RIGOROUS WAY. THE IDEA IS TO HAVE THOSE DO THE TEST BLINDED TO WHAT THEY'RE TEST SOG THERE'S A LOT OF -- TEST SOG THERE'S RIGOR AND WE REMOVE HUMAN BIAS AND THERE'S A DISCUSSION OF PAIN MODELS AND THERE WAS A DISCUSSION ON LAST ITEM NUMBER 5 WHICH IS THIS IS GOING TO BE A PROJECT AND LOTS OF DATA CREATION BUT WE WANT IT TO BE A USEFUL PLATFORM SO COMPANIES AND ACADEMICS CAN COME IN AND DON'T HAVE THEIR IP THREATENED AND WE LIKE TO SHARE AS MUCH DATA AS WE CAN. WE'LL BE THREADING THAT NEEDLE AS WE GO ALONG AND THERE'S DISCUSSION ON HOW WE PRIORITIZE WHAT WE TAKE IN AND IT'S HARD TO KNOW NOW. WE DON'T KNOW WHAT THE VOLUME WILL BE COMING IN BUT THAT'S AGAIN A DISCUSSION THAT OCCURRED DURING THE MEETING AND TAKING IN THINGS THAT LOOK TO HAVE A HIGH IMPACT AND FACTORING IN HOW FAR THEY ARE FROM BEING ABLE TO GOING INTO PATIENTS WHAT WE'D LIKE TO HAVE AT THE END FOR EACH ASSET IS A FLOW DIAGRAM OF WHAT WILL BE TESTED AND HOW AND IT WILL HAVE TO BE SFIFK FOR THE ASSET AND -- SCREENING FOR THE ASSET AND MORE AKIN TO WHAT THE CONDITION IS THAT WILL BE TESTED IN PATIENTS. LOTS OF DISCUSSION ABOUT THE FACT THAT WE HAVE TO HAVE THE PHARMACO KINETICS FIGURED OUT BEFORE WE GO INTO THE TESTING TO KNOW WHAT DOSES AND HOW TO ADMINISTER THEM AND SO FORTH. WE HAVE A CONTRACT WE'VE BEEN USING AND THE PROGRAM IS OPEN FOR GROUPS TO COME IN. THE NEW CONTRACT WILL COME OUT IN THE NEXT YEAR AND I THINK WILL BE A MORE SOPHISTICATED SYSTEM BUT PEOPLE WITH ASSETS THAT WANT TO TEST IN A NUMBER OF DIFFERENT PAIN MODELS CAN COME IN TO THE TRANSLATIONAL DIVISION AT NIAIDS AND THE TEST CAN BE DONE EVEN AT SOME LEVEL LY. NOW, THE OTHER PLATFORM WHICH IS THE ONE THAT NCATS IS RUNNING IS INTRAMURAL RESEARCH PROGRAM AND BASED ON HUMAN CELLS AND ASSAYS AND SO A NUMBER OF DIFFERENT COMPONENTS WHICH I'LL JUMP INTO RIGHT NOW SO RIGHT NOW THERE'S AN ANNOUNCEMENT OUT FOR ANNOUNCEMENT OF COLLABORATIVE OPPORTUNITIES TO DEVELOP DRUG AND HUMAN CELL BASED TESTING PROGRAM FOR OPIOIDS. NCATS HAS AN INTRAMURAL AND PEOPLE COME IN WITH THEIR COMPOUND AND EXPERTISE AND DEVELOP COLLABORATION WITH THE NCATS PIs TO HAVE THE RESOURCE TO TEST THEM IN THEIR UNIQUE SETTINGS. THE CONCENTRATION IS USING HUMAN CELLS FROM IPS CELLS TAKEN FROM SKIN AND BLOOD AND TRANSLATED TO NEUROTISSUE AS THAT WILL LIKELY BE THE FOCUS HERE. THESE CAN BE CULTURES AND THEY'RE WORKING ON ORGANOIDS AS WELL. SOME ARE ACCESS TO RELEVANT HUMAN CELL TYPES AND CHARACTERIZE THE CELLS AND HIGH THROUGHPUT SIGNALLING OF PATHWAYS, METABOLISM AND TRACKING CELL BEHAVIOR DENDRITIC GROWTH AND THINGS LIKE THAT AND COMBINING SINGLE CELL TRANSCRIPTOMICS AND PROTEOMICS. AND THEY HAVE CAPABILITIES IN TERMS OF DEVELOPING THE PROBES INTO THINGS THAT WILL BE MORE EFFECTIVE AND LIKELY TO BE COMMERCIALIZED AND THESE INCLUDE CHEMO INFORMATICS AND METABOLISM AND TOXICITY ASSAYS AND THEY HAVE LIBRARIES THEY CAN RUN ON ASSAYS THAT ARE PAIN RELEVANT AND SO THE IDEA HERE IS THAT THE NCATS RESOURCES WILL BE FOCUSSED ON DEVELOPING NON-ADDICTIVE PAIN THERAPIES AND THERAPIES THAT COULD POTENTIALLY MITIGATE AGAINST ADDICTION AND OPIOID USE DISORDERS. FINALLY, THEY HAVE THIS RFA OUT TO PROMOTE THE DEVELOPMENT OF SYSTEMS THAT COULD BE USED IN THESE TYPES OF ASSAYS SO TISSUE CHIP SYSTEMS TO ACTUALLY TEST NEW THERAPEUTICS THROUGH THE PIPELINE THAT WE JUST DISCUSSED. CHRIS, HOW DO WE DO? OKAY. SO THOSE ARE THE PRE-CLINICAL PLATFORMS. ANYBODY HAVE ANY QUESTIONS? >> ON THE TESTING STRATEGY SCREENING PROFILE AND VALIDATION, IT'S CURIOUS THE SCREENING IS FOR OPIOID BINDING. ARE YOU LOOKING FOR NO BIND -- BINDING? >> WE'LL TALK WITH THE CLINICAL PLATFORM. >> MY PART IS TO BRING YOU UP TO DATE TO WHERE WE ARE ON THE SET UP WHICH IS THE EARLY PHASE PAIN INVESTIGATION CLINICAL NETWORK DESIGNED TO TAKE DRUGS OR DEVICE THERAPEUTICS COMING FROM ACADEMIA OR INDUSTRY INTO EARLY PHASE CLINICAL TRIALS. AS WALTER SAID WE ARE COME BACK OF OF -- CONDITION AGNOSTIC AND LOOKING FOR IT TO TARGET SPECIFIC PAIN CONDITIONS AND NOT PAIN IN GENERAL AND TO SOME EXTENT ASSET AGNOSTIC WHERE WE WANT THINGS THAT ARE NON-ADDICTIVE AND INDE READY THAT'S WHERE OUR GOAL IS TO BE. WE'RE UP IN THE CLINICAL RESEARCH AND PAIN MANAGEMENT DOMAIN AND EVERYTHING I HAVE TO SAY IS SOLD UP AT THE TOP OF THIS SLIDE WHICH IS WE'RE READY TO OPEN. WE'RE OPENING FOR SUBMISSIONS OF APPLICATIONS FROM PHARMA OR ACADEMIA ON SEPTEMBER 3. SO THAT'S THE GIST OF WHAT I HAVE TO SAY. I DON'T HAVE STUDIES TO REPORT YET BECAUSE WE DON'T HAVE ANYTHING COMING IN. WE'RE AT THE STAGE HERE MUCH AUGUST 17 TO 24. WE'RE HAVING A WEBINAR FOR POTENTIAL APPLICANTS AND I BELIEVE REBECCA SENT INFORMATION ON THE WEBINAR IF YOU'D LIKE TO ATTEND IT AND WE'RE FINISHING UP THE APPLICATION PROCESS AND ON SEPTEMBER 3 WE OPEN. ONCE WE OPEN, WE HAVE A RATHER AGGRESSIVE TIME LINE FOR SUBMISSION AND REVIEW. EPIC NET IS BUILT AROUND A THREE-STAGE APPLICATION PROCESS. THE PRELIMINARY APPLICATION ASKS FOR BASIC INFORMATION ON THE ASSET BEING PROPOSED, THE PAIN CONDITION BEING TARGETED AND SOME EARLY DESIGN FOR THE CLINICAL TRIAL ITSELF. THAT UNDERGOES PEER REVIEW. THOSE THAT COME IN HIGHLY RATED PREPARE A DOSSIER. THE DOSSIER HAS MORE DETAILED INFORMATION ON PHARMACOLOGY AND PHARMACOKINETICS AND DYNAMICS AND DEVICES ON THE DEVICE SPECIFICS AND THEN THE DOSSIERS GO FOR INDEPENDENT REVIEW. THE DOSSIERS THAT COME THROUGH THE SECOND-LEVEL REVIEW HIGHLY RA RATED GO TO OUR CLINICAL COORDINATION CENTER TO GO WITH FULL CLINICAL TRIAL INFORMATION. TE PROTOCOL GOES FOR A FINAL LEVEL OF OBJECTIVE REVIEW AND THOSE THAT ARE SELECTED COME TO YOU ALL AND TO NIAIDS COUNCI FOR FINAL APPROVAL AND FUNDING AND IMPLEMENTATION. WE'RE AIMING FOR THE TIME LINES AND STARTING FIRST CLINICAL TRIALS IN 2020. SO THIS IS SET UP LIKE MANY OF THE OTHER NIAIDS CLINICAL TRIAL NETWORKS. HEAL AND NINDS PROVIDE THE LEADERSHIP. THERE'S A CLINICAL COORDINATING CENTER THAT SITS IN THE MIDDLE OF THE NETWORK AND I'LL GO INTO THE DETAILS OF WHAT EACH PROVIDES AND THERE'S A DATA MANAGEMENT CENTER OR DCC TO HELP WITH STATISTICAL INPUT AND DATA MANAGEMENT AND BRING IN THE DATA FROM BACKPACK AND HEAL AND EPIC NET FOR LATER SUBMISSION TO THE HEAL WIDE REPOSITORY. THE NETWORK WILL DESIGNATE A TRIAL PI TO SELECT THE HUBS AND SPOKES THAT WILL SEE THE PATIENTS AND RUN THE TRIAL BASED ON THE INVESTIGATORS AREA OF EXPERTISE AND THE AVAILABLE PAIN PATIENT POPULATIONS. THEY'LL ALL INTERACT WITH THE ASSET PROVIDER WHO WILL OTHERWISE PARTICIATE BUT WON'T BE INVOLVED IN THE ACTUAL CONTENT OF THE TRIAL. SO WE'RE AIMING TO INCREASE THE QUALITY AND BOUNCE THE PORTFOLIO ACROSS PAIN CONDITIONS AND DEMOGRAPHICS AND CREATE A PIPELINE AND HAVE A STABLE INFRASTRUCTURE IN FUNDING. WE'LL HAVE USE OF COMMON DATA ELEMENTS FOR ALL HEAL STUDIES IN A SINGLE DATA CENTER. WE'LL BE ABLE TO MANAGE COMPETITION FOR SIMILAR PATIENTS OR PATIENT COHORTS ACROSS THE TRIALS WHICH WILL ALSO HELP US COMPLETE THINGS AND IMPROVE EFFICIENCY AND COORDINATE WITH OUR NON-PROFIT INDUSTRIES AND PARTNERS. OUR INFRASTRUCTURE IS SET UP. WE HAVE SELECTED THE CCC, DCC AND TOMORROW I'LL TALK ABOUT HE HUB REISSUE. WE HAD LIMITED DIVERSITY IN TERMS OF OUR FIRST-ROUND HUBS THEY WERE ALL ISSUED AN RFA TO BRING IN MORE PAIN DISTRIBUTION AND BETTER GEOGRAPHIC DISTRIBUTION AND WE'LL TALK ABOUT THOSE SECOND HUBS TOMORROW. WE'VE BEEN FINALIZING THE APPLICATION TEMPLATES AND THE REVIEW PROCESS AIMING TOWARDS THE IMPLEMENTATION. SO THE CLINICAL COORDINATING CENTER WILL ADMINISTER THE CENTRALIZED IRB AND THE HUBS AND SPOKES. THEY'LL BE CHARGED WITH MATCHING THE ASSET WE'RE GOING STUDY TO THE SPECIFIC HUBS AND FOLKS AND THERE'S STANDARDIZING THE REPORT FORMS AND METHODOLOGIES AND WORKING ON THE OPERATING PROCEDURES AND QUALITY CONTROLS AND THEY'LL ALSO ADMINISTER THE FUNDS. THE DATA COORDINATING CENTER HANDLES THE DATA AND WILL PROVIDE THE STATISTICAL ANALYSIS AND REPORTS AND HARMONIZE DATA FOR THE REPOSITORY ONCE THAT'S UP AND RUNNING. THEY'LL RECORD THE MONITORING AND MANAGE THE BIOREPOSITORY FOR SAMPLES THROUGHOUT HEAL. THE HUBS AND SPOKES WILL HAVE THE INDIVIDUAL INVESTIGATORS AND PATIENTS AND COLLECT EVERYTHING AND REPORT TO THE DCC AND OTHER COMPONENTS AND WE CAN OVERSEE EVERYTHING. THE FUNDING FOR THE COMPONENTS OF THE INFRASTRUCTURE ARE U-24 COOPERATIVE AGREEMENTS. SO WE HAVE GONE THROUGH VIRTUALLY ALL THE STAGES NOW. OUR PRELIMINARY TEMPLATE IS PART OF AN APPLICATION PACKAGE YOU CAN FIND ON THE HEAL AND EPIC NET WEBSITES. THE DOSSIER TEMPLATE HAS BEEN DEVELOPED AND HELD BY THE CONTRACTOR FOR WHEN THE STUDY IS READY TO COME THROUGH FOR DOSSIER DEVELOPMENT. THE PROTOCOL TEMPLATE IS WHERE WE'RE USING THE FDA/NIH PROTOCOL TEMPLATE AS A BASIS. THAT'S BEEN DONE. THE REVIEW CRITERIA HAVE BEEN FINALIZED AND INCORPORATED INTO A RESEARCH OPPORTUNITY ANNOUNCEMENT TO BE POSTED SHORTLY AND THE INFORMATION WILL BE POSTED ON OUR WEBSITES. THIS IS AN OVERVIEW OF WHERE THE FUNDING IS. THE FIRST TWO STAGES OF APPLICATION THE PRELIMINARY ASSET APPLICATION AND THE DOSSIER APPLICATION ARE NOT ASSOCIATED WITH FUNDING. THOSE ARE JUST INTERMEDIARIES AND THE APPLICANT BECOMES THE CLINICAL COORDINATING CENTER THAT THE POINT BECAUSE THEY'RE THE ONES TO GET THE FUNDING TO DISTRIBUTE TO THE SITES TO RUN THE STUDY. SO THERE'S FUNDING ONLY ASSOCIATED WITH THE THIRD STAGE OF APPLICATION AND THAT IS COMING FROM OTHER TRANSACTION FUNDS RATHER THAN COOPERATIVE AGREEMENTS, GRANTS OR CONTRACTS AND AWARDS ARE MADE TO THE CLINICAL COORDINATING CENTER FOR DISTRIBUTION TO OTHER COMPONENTS INCLUDING HUBS AND SPOKES ON A. PATIENT BASIS. THEY GET ACCESS TO OUR NETWORK TO RUN THE CLINICAL TRIAL FOR THEIR ASSET. WE NEED TONE CLEAR ABOUT THAT. THERE ARE PROVISIONS IN PLACE FOR A TECHNOLOGY TRANSFER AGREEMENT TO PROTECT THEIR IP AND RIGHTS AND RETAIN RIGHTS TO THEIR PRODUCT. SO WE'RE TESTING COMPOUNDS AND DEVICES THROUGH THE THREE-STAGE PEER-REVIEW PROCESS THAT COME FROM ACADEMIA AND INDUSTRY AND ELSEWHERE IF SOMEBODY ELSE WANTS TO GIVE US SOMETHING. pFOR OUR NETWORK.ND SPOKE DESIGN WE ARE AIMED AT PHASE 2 CLINICAL TRIALS TO INCENTIVIZED AND ACCELERATE NEED FOR NON-EFFECTIVE PAIN TREATMENTS AND REDUCE THE TIME TO START UP AND COMPLETE THE TRIAL. WE'RE ALSO GOING TO INCORPORATE BIOMARKER AND DEEP PHENOTYPING KNEE TRIALS AND TRY TO DEVELOP -- INTO TRIALS AND TRY TO DEVELOP INNOVATIVE TRIAL DESIGNS. AS THE OTHER NETWORKS DO, WE HAVE EMPHASIS ON DATA AND ASSET SHARING IN OUR PARTNERSHIPS. SO OUR DCC IS GOING TO TAKE IN THE DATA AT EPIC NET AND BACKPACK AND HARMONIZE IT FOR THE HEAL REPOSITORY AND SPONSOR THE BIOSAMPLE REPOSITORY AND FINAL FINALLY WOULD LIKE TO SOLICIT YOUR HELP TO GET THE WORD OUT AND HELP US GET GOOD ASSETS COMING IN THROUGH EPIC NET. THANK YOU. >> THANKS VERY MUCH, BARBARA. QUESTIONS, COMMENTS? WE HAVE JUST A COUPLE MINUTES. AGAIN, THIS SAY PROGRAM ALREADY UP AND RUNNING BUT WE THOUGHT YOU SHOULD KNOW ABOUT IT PARTICULARLY AS IT RELATE TO TODAY AND TOMORROW IN TERMS OF WHAT EPIC NET OFFERS AS FAR AS A CLINICAL TRIAL OPPORTUNITY AND ARE HOPING THE ASSETS WHEN THEY GET THE DOOR OPEN SEPTEMBER 3 WILL COME IN WITH LOTS AND LOTS OF INTERESTING COMPOUNDS, DEVICES TO PUT INTO THE PARTICULAR MACHINE FOR DISCOVERY. I DON'T KNOW IF ANY OF THE FOLKS ON THE HPC WANT TO COMMENT LIKE JUDITH OR KEN OR CHRISTINE BECAUSE YOU JOINED THE MEETING AUGUST 1 WHERE WITH TALKED A BIT ABOUT THIS. ALL IS WELL. OKAY. >> WE SHOULD SAY BEFORE MOVING ON THOUGH WE'RE NOT YET OPEN FOR SUBMISSIONS, ALL THE INFORMATION IS NOW AVAILABLE ON OUR WEBSITE TO PREPARE YOUR SUBMISSIONS AND WHEN SEPTEMBER 3 COMES WE'LL RAPIDLY BE EVALUATING THEM AND MOVING FORWARD. >> THIS MAY BE GET INTO THE WEEDS AND FOLLOWING UP ON THE PREVIOUS QUESTION, IF ONE HAS AN ASSET THAT IS THOUGHT TO BE OPIOID SPARING BUT IS AN OPIOID, LET'S SAY IT'S A BIASSED OPIOID AGONIST IS THAT RULED OUT FROM THIS? >> NO, WE'RE INTERESTED IN BIASSED AGONISTS. >> IF IT'S PERFORMING LIKE AN OPIOID WE'D DROP IT. >> BUT BIASSED AGONIST WOULD BE OF INTEREST IF THEY ARE RELIABLE THAT WAY. >> AND LET ME SAY IF YOU HAVE OPIOID DRUG THAT DOESN'T GO IN THE BRAIN YOU CAN USE THE POWER OF THE OPIOID IS AN NAL -- ANALGESIC. >> WE'RE HOPING TO DO THE REVIEWS CONTINUOUS. VERY SEPARATE FROM WHAT NIH DOES OTHERWISE. THEY'LL PRIORITIZE CONTINUALLY AND GET MORE INFORMATION BEFORE THEY DELIVER SOMETHING TO GO TO A CLINICAL TRIAL. >> BUT COMING IN EARLY IS A GOOD THING SO IF YOU HAVE AN ASSET WE HAVE UNTIL SEPTEMBER AND -- SEPTEMBER 3. >> THE ASSET PROVIDER IS BRINGING THIS TO THE TABLE BUT THE TRIAL P.I. COMES FROM ELSEWHERE. CAN YOU EXPLAIN WHO THE TRIAL P.I.s ARE IN THIS CASE. >> THEY'RE PROBABLY GOING TO BE THE HUB P.I. WHO HAVE THE CLOSEST MATCHED EXPERTISE AND PATIENT POPULATION AVAILABLE TO MATCH WITH THAT ASSET. THE SELECTION WILL BE A COLLABORATIONTOWN THE ASSET OWNER -- COLLABORATION BETWEEN THE ASSET OWNER AND ICC HUBS IN ORDER TO IDENTIFY THE CLOSEST FIT. >> I'M LOOKING TO HEAR WHAT ASSET HOLDERS SAW AND ARE THEY LOOKING TO DERISK OR LOOKING TO OBVIATE THE COST. >> DO YOU WANT TO RESPOND TO WALLY'S QUERY? >> IT'S MULTIFACTORIAL AND SOMETHING WE'VE BEEN BUILDING ON A COUPLE YEARS. ONE IS ACCESS TO A WELL PHENOTYPED POPULATION. YOU CAN PREDICT WHAT I'M GOING TO SAY HERE AND TYPICALLY WHEN WE LAUNCH INTO A NEW PAIN AREA, WE DON'T DO THE PROPER FOUNDATIONAL ASPECTS OF IT. WE'RE NOT SURE HOW WELL THE INVESTIGATORS HAVE PHENOTYPED OR CHARACTERIZED THEIR PATIENTS. SO A LOT OF IT IS THAT SORT OF THING. WE FIGURE WITH AN EMBEDDED NETWORK AND IDENTIFIED HUBS AND SPOKES AND BASICALLY FOR US IS HIGHER QUALITY CLINICAL TRIALS THAN WHAT WE'VE BEEN ABLE TO EXECUTE ON OUR OWN. >> JUST BUILDING ON WHAT ALAN WAS ASKING ABOUT IN TERMS OF OPIOID TARGETED MEDICATIONS, WILL SIMILAR CONSIDERATIONS BE GIVEN TO THE ADDICTIVE POTENTIAL OF SOME DRUGS. >> THE POTENTIAL IS RELATED TO THE PHARMACOKINETICS AND HOW RAPIDLY THEY ENGAGE THE DOPAMINE RECEPTORS AND IT MAY NOT NECESSARILY BE ADDICTIVE AS WHAT HAPPENS WITH THE ANTI-DEPRESSANTS. AND YOU CAN BE ADDICTED WITH AN ANALGESIC WITHOUT ENGAGING THE OPIOID SYSTEM SUCH AS AS THE CANNABINOID RECEPTOR SYSTEM AND THE ANIMAL MODELS HAVE PRETTY GOOD PREDICTION CAPACITY TO TELL US AND WHICH ARE LIKELY TO HAVE ADDICTION POTENTIAL IN HUMANS. THAT IS THE KEY ELEMENT OF WHETHER TO GO OR NOT GO. >> I WOULD ADD ONE OF THE OTHER CAPABILITIES WE IS TO PARTNER WITH THE PROGRAM FOR A DRUG TO DO POTENTIAL TESTING IN PREPARATION FOR A CLINICAL TRIAL. THERE'S THAT TYPE OF ALLIANCE AS WELL. >> CHRISTINE. >> I REMEMBER IN A PRIOR PARTNERSHIP COMMITTEE MEETINGS ONCE THE ASSET OWNER ONCE IT MOVES FORWARD TO THE CLINICAL TRIAL WHETHER THERE'S GOING TO BE AN OPPORTUNITY FOR THE ASSET PROVIDER TO BE IN THE CONDUCT OF THE TRIAL OR HANDS-OFF APPROACH AND WE DISCUSSED THAT AND IT WAS BROUGHT UP BY MEMBERS OF INDUSTRY BUT I DON'T KNOW WHICH WEATHER THERE'S ADDITIONAL CLIFF CLIFF -- CLARIFICATION. >> IT'S A HANDOFF AND THERE'S AN AGREEMENT WITH EACH ASSET OWNER TO DEFINE A RELATIONSHIP IF THERE'S A CLEAR ROLE IN THE ASSET OWNER IN THE CLINICAL TRIAL WE CAN NEGOTIATE THAT AND INCORPORATE THAT IF IT'S AN IMPORTANT PART BUT THE INTENT IS BASICALLY A HANDOFF. >> DO YOU HAVE ANOTHER COMMENT? >> YES, IT SEEMS LIKE IT'S CRITICAL TO HAVE THE PROCESS FROM THE PRELIMINARY APPLICATION TO THE DOSSIER PREPARATION TO THE PROTOCOL PREPARATION PASS A NUMBER OF REVIEW STEPS AND THERE'S INVESTMENT INVOLVED IN THAT I'M ASSUMING ON THE PART OF THE ASSET HOLDER, CORRECT? >> NO, THAT'S COVERED BY THE FUNDING FOR THE INFRASTRUCTURE AND THERE'S A CONTRACT WITH THE COMPANY THAT WILL PREPARE THE DOSSIER SO WE ARE PROVIDING THOSE FUNDS. >> AND WHO IS MARCHING THINGS THROUGH? ASSET HOLDER OR POTENTIAL HUB P.I.? >> WHO IS BRINGING THINGS THROUGH THE REVIEW PROCESS? >> YES. >> THE EPIC NET LEADERSHIP. >> SO TO THE ASSET HOLDER IT WOULD BE A BLACK HOLE. >> AN PARTNER IN DOING THAT. >> I'M TRYING TO UNDERSTAND BETTER. >> THE INITIAL STAGES ARE A PARTNERSHIP BETWEEN US AND THE ASSET HOLDER. CORRECT. >> I THINK WE PROBABLY SHOULD MOVE ALONG. THANK YOU VERY MUCH ALL THE PRESENTERS FOR OUR OPEN SESSION. WE'RE GOING TO TAKE A 10-MINUTE BREAK AND THEN WE'LL GO INTO CLOSED SESSION SO DURING THAT BREAK ANYBODY WHO IS NOT FEDERAL EMPLOYMENT READY OR OCCUPIED AT THE PRESENT TIME OR ON THIS PARTICULAR GROUP MIGHT JUST GO FIND SOMETHING ELSE TO DO. AND WHEN WE RECONVENE AT 10:10 WE'LL START HEARING WITH THE NIAIDA CLINICAL TRIALS NETWORK AND THERE'S A COFFEE BAR DOWN THE HALL AND SINCE WE PROVIDED YOU WITH WONDERFUL REFRESHMENTS, NAMELY WATER, BUT IF YOU WANT SOMETHING MORE THAN THAT AND HAVE YOU CASH, IT'S AVAILABLE. THANK YOU. SEE YOU SHORTLY.