>> GOOD MORNING. A PLEASURE TOO SEE THOSE IN MASUR AND WELCOME TO THOSE WATCHING REMOTELY. WE'RE ABOUT TO INITIATE THE PLENARY SESSION NUMBER TWO. NIH RESEARCH FESTIVAL ON RESPONDING TO PUBLIC HEALTH EMERGENCIES. THIS IS OF COURSE THE RESEARCH FESTIVAL ANNUAL SHOWCASE OF NIH CONTRIBUTION TO BIOMEDICINE, THIS SESSION I THINK WAS CONTEMPLATED PERHAPS INITIALLY BY THE VERY STRONG FOCUS IN THIS COUNTRY OVER THE LAST YEAR ABOUT THE EBOLA OUTBREAK M. AFRICA WHICH REACHED OUR SHORES AND WHERE NIH PLAYED A CENTRAL AND CONTINUES TO PLAY AN ABSOLUTELY CENTRAL ROLE IN RESPONDING TO THAT OUTBREAK. THAT'S NOT THE ONLY TIME THAT NIH HAS BEEN CALLED AS A FIRST RESPONDER FOR PUBLIC HEALTH EMERGENCIES. YOU COULD POINT TO THE FUKUSHIMA NUCLEAR DISASTER, WHERE WE RESPONDED QUICKLY, TO THE CONCERNS THERE ABOUT NUCLEAR CONTAMINATION. THE DEEP WATER HORIZON SPILL, WHERE WE HAVE HAD ONGOING SUBSTANTIAL INVESTMENT IN UNDERSTANDING THE CONSEQUENCES OF EXPOSURE TO INDIVIDUALS OF THAT MAJOR ECOLOGICAL DISASTER, TO HURRICANE KATRINA WHERE WE HAD SOME WHO VOLUNTEERED AND SOME ASSIGNED TO TAKE CARE OF A TERRIBLE DISASTER THERE IN NEW ORLEANS. GOING BACK FOR MANY YEARS, NIH HAS BEEN THERE WHEN THESE EMERGENCIES HAVE STRUCK OUR COUNTRY AND THEY WILL CONTINUE TO, EVEN THOUGH WE LIKE TO THINK MAYBE THOSE ARE IN THE PAST, LOOKING AT HISTORY YOU CAN BE SURE THERE'S OTHERS LOOMING OUT THERE AHEAD. IT IS INEVITABLE SUCH EMERGENCIES WILL HAPPEN. WHAT IS NOT INEVITABLE IS WE'LL FIGURE OUT HOW TO MOUNT A RESEARCH RESPONSE THAT TAKES A LOT OF PLANNING, A LOT OF THOUGHT, AND EXPERIENCE HELPS IN THIS REGARD AND YOU'RE GOING TO HEAR TODAY FROM PEOPLE WHO HAVE BEEN IN THE MIDST OF SUCH RESPONSES AND I HOPE IT WILL MAKE YOU THINK ABOUT AREAS THAT WE MIGHT EVEN IN THE FUTURE BE EVEN BETTER PREPARED. SO WE HAVE IN FACT I THINK ASSEMBLED IN THIS PANEL THIS MORNING PEOPLE WHO CAN TALK ABOUT THIS FROM VERY DIFFERENT PERSPECTIVES BUT YOU'LL FIND IT TO BE SYNERGISTIC. I'M GOING TO LET MICHAEL GOTTESMAN INTRODUCE THEM. WE'LL HEAR FROM CLIFF LANE ABOUT THE CLINICAL RESEARCH RESPONSE TO EBOLA. CLIFF HAS BEEN ABSOLUTELY OUT THERE IN FRONT OF THIS EFFORT, BOTH HERE IN THE U.S. AND ESPECIALLY IN WEST AFRICA. WE'LL HEAR FROM PAMELA COLLINS ABOUT OUR EFFORTS TO ADDRESS THE SILENT EPIDEMIC OF MENTAL HEALTH PROBLEMS AND EMERGING GLOBAL HEALTH CRISIS. AND WE'LL HEAR FROM DAVID LIPMAN ABOUT FOOD SAFETY ISSUES WHICH WE NEED TO HAVE A BETTER HANDLE ON AND HE THROUGH NCBI HAS BEEN WORKING ON A NATIONAL GENOMICS NETWORK WHICH CAN BE A POWERFUL TOOL FOR THE KIND OF DETECTIVE WORK THAT'S NECESSARY TO SORT OUT WHEN ONE OF THOSE THINGS HAPPEN. AFTER THOSE PRESENTATIONS THERE WILL BE A PANEL DISCUSSION, TONY FAUCI WILL MODERATE, LINDA BIRNBAUM WILL BRING HER SPECK ACTIVE IN NIEHS, HIGHLIGHTING THE THINGS OUR INTRAMURAL PROGRAM IS DEEPLY INVESTED IN. I THINK YOU WILL GREATLY ENJOY THIS. AT THIS POINT I WILL GET OUT OF THE WAY AND LET MICHAEL GOTTESMAN WHO I SHOULD GIVE A TIP OF THE HAT FOR THE PLANNING AND RESEARCH FESTIVAL. MICHAEL, COME AND INTRODUCE THE SPEAKERS. [APPLAUSE] >> OUR FIRST SPEAKER IS SOMEONE WELL KNOWN TO ALL OF YOU, CLIFF LANE, HE'S THE NIAID DEPUTY DIRECTOR FOR CLINICAL RESEARCH AND SPECIAL PROJECTS AND ONE OF OUR INTRAMURAL PROGRAM'S MOST DISTINGUISHED SCIENTISTS. IN HIS RESEARCH, HE STUDIED IMMUNOREGULATORY MECHANISMS THAT CONTROL THE HUMAN IMMUNE RESPONSE TO SPECIFIC ANTIGEN CHALLENGES, AND AS YOU ALL KNOW WHEN THE AIDS CHALLENGE FIRST EMERGED, CLIFF WAS AT THE FOREFRONT OF INVESTIGATORS WHO ESTABLISHED WHAT THE IMMUNOPATHOGENNIC MEASURES WERE THAT LED TO HIV DISEASE. THIS PAST YEAR, CLIFF HAS SPENT MANY MONTHS, OFF AND ON IN WEST AFRICA, WORKING VERY HARD ON THE EBOLA CRISIS, INCLUDING THE DEVELOPMENT OF VACCINE TRIALS IN LIBERIA. MEDICAL DEGREE FROM UNIVERSITY OF MICHIGAN, COMMISSIONED OFFICER WHERE HE ROSE TO THE RANK OF REAR ADMIRAL, AND HE'S OF COURSE A MEMBER OF THE NATIONAL ACADEMY OF MEDICINE. WITHOUT FURTHER ADO I'LL INTRODUCE CLIFF WHOSE TALK IS "THE WEST AFRICAN CLINICAL RESEARCH RESPONSE TO EBOLA." CLIFF? >> THANKS, MICHAEL, FOR THE VERY KIND PRODUCTION. I HAVE TO SAY I USUALLY DON'T LIKE TO TALK. I HAVE TO ADMIT, IN PUBLIC I LIKE TO LISTEN. I LIKE TO WRITE. BUT YOU HAVE TO TALK EVERY SO OFTEN. BUT I HAVE TO SAY WHEN I WAS ASKED TO GIVE THIS TALK I WAS HAPPY AND EXCITED BECAUSE IT'S THE NIH INTRAMURAL RESEARCH FESTIVAL, AND I CAN'T THINK OF AN INSTANCE, AND MICHAEL WAS KIND ENOUGH NOT TO SAY IT, MY 36 YEARS AT THE NIH I'VE SEEN THE INTRAMURAL COMMUNITY AS A GROUP COME TOGETHER TO TRY TO DEAL WITH SOMETHING OF GLOBAL IMPORTANCE THE WAY THAT THEY HAVE IN THE SETTING OF EBOLA. I CAN REMEMBER WHEN WE WERE DEALING WITH SOME OTHER THINGS, SARS COMES TO MIND, THAT WE WOULD BE READING THINGS IN THE MEDIA OF HOW DARE WE, YOU KNOW, BRING PATIENTS LIKE THIS TO THE NIH. HOW DARE WE COMPROMISE THE HEALTH OF THE OTHER PATIENTS IN THE CLINICAL CENTER, OR THE COMMUNITY OF BETHESDA. WE HAD NONE OF THIS WITH THE EBOLA. IT REALLY WAS AMAZING TO ME HOW EVERYBODY THAT WE'VE INTERACTED WITH HAS BEEN SO INCREDIBLY SUPPORTIVE. IT REALLY MADE ME VERY PROUD TO BE A MEMBER OF THE INTRAMURAL COMMUNITY OF THE NIH IN GENERAL, AND I'LL GIVE YOU SOME EXAMPLES OF WHAT WE'VE DONE. I'LL GO THROUGH IT QUICKLY SO I CAN GIVE YOU THE OVERALL VIEW OF WHAT WE'RE DOING, BUT IT REALLY HAS BEEN AN EFFORT INVOLVING THOUSANDS OF PEOPLE REALLY AND DOING ALL SORTS OF DIFFERENT THINGS BECAUSE I THINK AS YOU KNOW, TO CARRY OUT A CLINICAL RESEARCH PROJECT IN GENERAL TAKES MULTIPLE PLAYERS, TO CARRY OUT A CLINICAL RESEARCH PROJECT OUTSIDE OF THE U.S. TAKES MANY PLAYERS. AND IN A PLACE THAT HAD NO CLINICAL RESEARCH TO SPEAK OF TO BEGIN WITH IS JUST EXTRAORDINARY. IT'S REALLY BECAUSE OF THE EXPERTISE THAT RESIDES HERE AT NIH AND THE PREPAREDNESS THAT WAS ALREADY A RESIDENT AT NIH FOR THESE TYPES OF ISSUES. SO THIS FIRST SLIDE GIVES YOU AN IDEA OF HOW THIS PARTICULAR OUTBREAK COMPARES TO ALL OTHER OUTBREAKS COMBINED. I THINK EVERYONE IS AWARE THAT THE NUMBER OF DEATHS IS OVER 10,000. AND IT JUST WAS COMPLETELY DEVASTATING TO THE THREE COUNTRIES IN WEST AFRICA. BUT THIS OUTBREAK WAS NOT THE FIRST TIME THE INTRAMURAL RESEARCH COMMUNITY WAS INVOLVED IN LOOKING AT EBOLA AS A POTENTIAL PATHOGEN OF IMPORTANCE TO HUMANS. OUR VACCINE RESEARCH CENTER INITIALLY ESTABLISHED BY GARY ENABLE HAD BEEN DOING EBOLA WORK CARRIED ON BY NANCY SULLIVAN AND ONE OF THE CANDIDATE VACCINES WE WERE TESTING WAS SOMETHING THAT NANCY WAS RESPONSIBLE FOR AND YOU MAY REMEMBER WHEN PRESIDENT OBAMA WAS HERE SEVERAL MONTHS AGO HIGHLIGHTING THE WORK OF NANCY AND HER COLLEAGUES AT THE VRC. WE HAVE WITHIN NIAID BSL-4 LABS DOING NON-HUMAN PRIMATE STUDIES OUT OF ROCKY MOUNTAIN, AND FORT DETRICK. WE HAD BUILT FROM ONE OF THE SHELLED OUT AREAS DURING THE COST OVERRUN TIME, WE HAD BUILT OUT A SPECIAL CLINICAL STUDIES UNIT. INDEED WE ENVISIONED THAT UNIT WOULD BE USED TO ISOLATE POTENTIAL CONTAMINATIONS FROM OUR BSL-4 LABS, THE U.S. GOVERNMENT LABS AT FORT DETRICK, NEVER DREAMING THAT WOULD BE USED TO HOUSE EBOLA PATIENTS MEDEVACED FROM WEST AFRICA AND HAD BEEN CONDUCTING WORKSHOPS THROUGHOUT THE INTERAGENCY, DoD, HHS, DHS, DEPARTMENT OF HOMELAND SECURITY, WE'RE DOING WORK IN HIGH CONTAINMENT LABS, VACCINES, WHAT WE DO IN TERMS OF THERAPEUTICS IF WE HAD EXPOSURE. A LOT OF WORK HAD BEEN UNDERWAY IN THE INTRAMURAL PROGRAM THAT REALLY PREPARED US WELL FOR DEALING WITH EBOLA OUTBREAK. THE FIRST RESPONDERS OF THE FIRST RESPONDERS WERE OUR BSL-4 LAB STAFF DEPLOYED TO WEST AFRICA, PRIMARILY LIBERIA, HERE YOU SEE THEM, TO DO THE DIAGNOSTICS. THESE GUYS AND THEIR COLLEAGUES WERE OVER THERE IN LIBERIA RUNNING THE PCR ASSAYS, AS WELL AS SOME DoD STAFF. AGAIN, VERY EARLY ON, MARCH OF LAST YEAR WAS WHEN LISA I THINK WAS THE FIRST PERSON FROM NIAID TO GO OVER. I MENTIONED WE HAVE HERE ONE OF THE THREE SPECIALIZED UNITS IN THE UNITED STATES EQUIPPED TO HANDLE PATIENTS WITH EBOLA VIRUS INFECTION. THAT UNIT WAS FORTUNATELY AVAILABLE WHEN THERE WAS A NEED TO EVACUATE INDIVIDUALS HERE FROM EITHER WEST AFRICA OR DALLAS, AND I THINK ONE OF THE BIG MEDIA EVENTS OF THE YEAR FOR ME AT LEAST WAS THE DISCHARGE OF NINA PHAM, WHO BECAME A SYMBOL OF MANY DIFFERENT THINGS FOR MANY DIFFERENT PEOPLE, BUT I CAN TELL YOU WHAT IT WAS FOR OUR UNIT. IT WAS REALLY A GREAT OPPORTUNITY TO PUT INTO PRACTICE ALL THE TRAINING. THIS SPECIAL CLINICAL STUDIES UNIT, IT IS CONSTANT STATE OF REPAIR UNDER RICK DAVIES DIRECTION, HE DOES A GREAT JOB MAKING SURE THE UNIT IS READY FOR WHATEVER MIGHT BE COMING OUR WAY. THAT WAS THE FIRST EXAMPLE OF PEOPLE COMING TOGETHER IN A VOLUNTARY WAY TO CARE FOR PATIENTS WITH EBOLA VIRUS INFECTION, IN ADDITION TO NINA WE HAD ONE OTHER PATIENT, BOTH WERE ILL. WE HAD PEOPLE FROM ALL THE DIFFERENT INSTITUTES AND CENTERS OF THE NIH HELPING OUT WITH THE CARE IN THE SPECIAL CLINICAL STUDIES UNIT, AS YOU CAN SEE RANGING FROM ASSISTANT CLINICAL INVESTIGATOR LIKE DAN CHERTOW TO INSTITUTE DIRECTOR LIKE TONY FAUCI, COMING TOGETHER OF THE INTRAMURAL COMMUNITY IN THIS BUILDING. I'M GOING TO TALK ABOUT WHAT'S GOING ON IN WEST AFRICA. AND WE AS AN INSTITUTE DO HAVE A CONSIDERABLE PRESENCE INTERNATIONALLY. OBVIOUSLY PART OF THE YOUR PORTFOLIO IS INFECTIOUS DISEASES, YOU NEED TO GO WHERE THOSE INFECTIONS ARE. AND MANY OF THE INFECTIONS WITH THE HIGHEST GLOBAL BURDEN LIKE HIV, TB AND MALARIA DO NOT OCCUR IN THE U.S. SO WE DO QUITE A BIT OF WORK OVERSEAS. DR. FAUCI IS FOND TO SAY WHEN HE GETS UP EVERY MORNING HE DOESN'T KNOW IF WE NEED TO LAUNCH A NEW PROGRAM, THAT'S WHY OUR INSTITUTE HAS A DEPUTY DIRECTOR FOR SPECIAL PROJECTS, IN CASE THOSE THINGS NEED TO BE ADDRESSED IN SOME WAY. BUT ONE OF THE VERY IMPORTANT PRINCIPLES FOR US IN THESE ENGAGEMENTS OVERSEAS IS TO BE SURE THAT WHAT WE'RE DOING IS SOMETHING THAT IS DESIRED BY THE HOST GOVERNMENT, AND INDEED WHEN WE WERE FIRST APPROACHED ABOUT DOING WORK IN WEST AFRICA WE MADE IT CLEAR TO THOSE ASKING US THAT, YOU KNOW, WE'RE HAPPY TO ENGAGE BUT IT REALLY NEEDS TO BE SOMETHING THAT WE'RE SURE AS A U.S. GOVERNMENT AGENCY THAT THE GOVERNMENT OF THE COUNTRIES IN NEED OF THAT ASSISTANCE WANT IT TO HAPPEN. AS YOU CAN SEE FOR EACH OF THE THREE OUTBREAK COUNTRIES WE'VE RECEIVED REQUESTS, HAD RECEIVED REQUESTS FIRST IN AUGUST, FROM THE MINISTER IN LIBERIA, TO SECRETARY BURWELL, SIERRA LEONE IN FEBRUARY OF -- THAT SHOULD BE 2015, FROM THE CHIEF MEDICAL OFFICER TO INITIATE TREATMENT TRIALS, FOR HELP AND ESTABLISHMENT OF CLINICAL RESEARCH PROGRAM, A VERY IMPORTANT COMPONENT OF THE WORK WE DO OVERSEAS. AS I MENTIONED AT THE BEGINNING, AS WE BEGAN TO WORK IN LIBERIA IT WAS QUITE CLEAR THERE WAS LITTLE INHERENT INFRASTRUCTURE FOR DOING CLINICAL RESEARCH. THAT DOESN'T MEAN THAT THERE WERE NOT PROFESSIONALS WHO HAD TRAINING AND COULD DO CLINICAL RESEARCH, THERE HAD NEVER BEEN ANYTHING OTHER THAN A SMALL INDUSTRY SPONSORED TRIAL AND NONE OF THAT WORK HAD BEEN DONE IN QUITE SOME TIME. WE WORKED WITH COLLEAGUES IN LIBERIA TO PUT TOGETHER A PROGRAM TO CONDUCT CLINICAL RESEARCH. YOU CAN SEE AT THE BOTTOM OF THE SLIDE ALL THE DIFFERENT PIECES THAT YOU NEED TO BRING TOGETHER, TO HAVE AN EFFECTIVE PROGRAM, BECAUSE AS WE BEGAN DOING THIS IT BECAME CLEAR IF WE DID CLINICAL RESEARCH AND DO IT RIGHT, WE WOULD HAVE TO INVEST IN INFRASTRUCTURE AND IF WE MAKE THIS INVESTMENT IN INFRASTRUCTURE WE SHOULD DO IT IN A WAY TO ALLOW US TO DO THINGS BEYOND EBOLA. WE HAD QUITE A PRESENCE ALREADY IN BAMACOA MALI FOR MALARIA WORK ESTABLISHED BY OUR DIVISION OF INTRAMURAL RESEARCH, WE WANTED TO MODEL WHAT WE BEGAN IN LIBERIA AND NOW EXTENDED TO GUINEA, ALONG THOSE SAME LININGS. WE BROUGHT TOGETHER SUBJECT MATTER EXPERTS FROM THE NIH PREDOMINANTLY INTRAMURAL COMMUNITY, PAIRED THEM UP WITH COLLEAGUES IN LIBERIA TO LOOK THROUGH ALL THE DIFFERENT COMPONENTS FROM SOCIAL MOBILIZATION, WE HAD STRUCTURE WITH COMMAND AND CONTROL AND HAD THE WHOLE PROGRAM ULTIMATELY ACCOUNTABLE TO THE U.S. AMBASSADOR IN THE COUNTRY AND THE MINISTER OF HEALTH. THE NIH PIECE OF THIS AS A WHOLE BEGAN VERY EARLY THIS YEAR, JANUARY 2, WHEN DR. COLLINS SENT OUT A NOTE TO BASICALLY ALL STAFF AT THE NIH WHO MIGHT IN ANY WAY, SHAPE OR FORM BE ABLE TO HELP WITH THE CLINICAL RESEARCH ENTERPRISE, ASKING FOR VOLUNTEERS, TALKING ABOUT INITIALLY THE VACCINE AND THERAPEUTIC TRIAL AND WE'VE HAD AN OVERWHELMING RESPONSE TO THAT REQUEST AND WE'RE STILL ALWAYS LOOKING FOR VOLUNTEERS, IF YOU'RE INTERESTED PLEASE DROP A NOTE TO BETSY AT HER E-MAIL. INDEED AT THIS POINT IN TIME WE'VE HAD OVER 100 STAFF FROM NIH, MOSTLY INTRAMURAL, FROM 14 INSTITUTES TRAVEL TO WEST AFRICA TO HELP WITH THESE EFFORTS. I CAN'T TELL YOU HOW APPRECIATIVE WE ARE AS AN INSTITUTE FOR THE WORK EVERYONE HAS DONE. NO ONE GOT SPECIAL PAY FOR THIS. NO ONE GOT TIME OFF. COMPENSATORY TIME. NO ONE FLEW BUSINESS CLASS UNLESS THEY USED THEIR OWN MILES SO IT WAS QUITE A SACRIFICE FOR EVERYONE WHO DID THIS AND HOPEFULLY THERE WAS SOME REWARD THAT CAME BACK WITH IT. JUST TO TALK ABOUT THE THINGS THAT WE'VE BEEN DOING, VACCINES, THERAPEUTICS, NATURAL HISTORY, LEAD VACCINE CANDIDATES AT THE TIME THAT WE STARTED RECOMBINANT ADENOVIRUS, WITH OR WITHOUT A BOOST, THREE TRIALS ONGOING IN WEST AFRICA, THE ONE WE'RE DOING, THE CLASSIC PLACEBO CONTROLLED TRIAL, THE ONE CDC IS DOING WHICH IS MEDIA VERSUS DEFERRED IMMUNIZATION WITH VSV OF HEALTH CARE WORSEE AND THE RING VACCINATION STUDY IN GUINEA, WITH PUBLICITY LATELY. THERE IS GREAT OPTIMISM WHEN WE'LL HAVE A VACCINE, IT'S BEEN THE CHALLENGE FOR HIV. WE KNOW PEOPLE WHO SURVIVAL DO IT WITH A DISAPPEARANCE OF CIRCULATING VIRUS AND WE BELIEVE A STATE OF PROTECTIVE IMMUNITY. UNFORTUNATELY, THERE'S NO CLEAR LABORATORY CORRELATE OF THAT STATE OF PROTECTIVE IMMUNITY, MAKING DEVELOPMENT OF A VACCINE MUCH MORE DIFFICULT FROM A NON-TRADITIONAL PATHWAY AND THUS THE OPPORTUNITY TO DO A CLINICAL ENDPOINT STUDY WAS AN ENORMOUS OPPORTUNITY FOR THE FIELD. THE TWO CANDIDATES WE LOOKED AT, ONE WAS RECOMBINANT VSV DEVELOPED BY PUBLIC HEALTH AGENCY OF CANADA AND THE CHAMP AD 3 DEVELOPED BY NANCY SULLIVAN AND VACCINE RESEARCH CENTER. GRABBING DAT AT FROM PHASE 1 STUDIES DONE, ACTUALLY BOTH PHASE 1 STUDIES TOOK PLACE IN THE CLINICAL CENTER, CHIMP AD-3 BY JULIE LEDGERWOOD, AND VRC ON THE FIFTH FLOOR AND VSV BY RICK DAVIES AND THEIR COLLEAGUES ON THE EIGHTH FLOOR CLINIC. NANCY RAN THE ANTIBODY ASSAYS SO WE WOULD COMPARE THE TWO VACCINES. YOU CAN SEE IN TERMS OF ANTIBODY THEY LOOK FAIRLY COMPARABLE. THE STUDY WE DESIGNED AND INITIATED WAS A CLASSIC PLACEBO-CONTROLLED RANDOMIZED CLINICAL TRIAL WITH A SALINE PLACEBO, COHORT SIZE OF 27,000, WITH THE FIRST 600 SLATED TO ENROLL IN A MORE INTENSIVE STUDY WITH LABORATORY EVALUATIONS AT WEEK ONE AND FOUR AND THEN DEPENDING UPON THE SAFETY ANALYSIS AND IMMUNOGENICITY ANALYSIS AT WEEK FOUR KEEPING IN MIND THAT POPULATION HAD NOT BEEN STUDIED PRIOR TO THIS TRIAL, WE WOULD THEN GET A GREEN LIGHT FROM THE DSMV TO GO AHEAD WITH THE LARGER COHORT. IT LAUNCHED IN FEBRUARY, THIS IS THE INITIAL SCREENING, REDEMPTION HOSPITAL, STAFF USING THE PERSONAL PROTECTIVE EQUIPMENT SCREENING INDIVIDUALS AS THEY CAME IN. BEFORE YOU WENT INTO THIS HOSPITAL, OR BASICALLY ANY PUBLIC BUILDING IN LIBERIA AT THE TIME, YOU HAD YOUR TEMPERATURE CHECKED WITH A FOREHEAD SENSOR AND MY TEMPERATURES RANGED FROM 32 TO 34 MOST OF THE TIME. YOU ALSO HAD SOMEONE ASKING IF YOU HAD SYMPTOMS, THIS IS JUST ANOTHER LEVEL OF SCREENING THAT WAS DONE AT REDEMPTION. THE INFORMED CONSENT PROCESS WAS QUITE THOROUGH YET GEARED TO THE POPULATION. YOU CAN SEE HERE MELVIN JOHNSON, WHO WAS THE LEAD COORDINATOR FOR THE SITE OF REDEMPTION DOING CLASSROOM PRESENTATION, BEHIND HIM ARE THE PICTURES. STUDY. MARK KEY GAVE A TALK HERE A FEW MONTHS AGO, HEAD PHYSICIAN FOR THE STUDY AT REDEMPTION. BEHIND HIM IS ONE OF THREE PRIVATE ROOMS AFTER THE CLASSROOM SETTINGS THE VOLUNTEERS WOULD HAVE A PRIVATE SESSION AND GIVE YOU AN EASY WAY TO OPT OUT, AN IDEA OF WHAT THE PAGES LOOK LIKE, TRYING TO GET THE CONCEPT OF RANDOMIZATIONS MAKING SURE EVERYONE KNEW WHAT THEY WERE ENROLLING IN. WE WERE TOLD AS WE STARTED THIS THAT YOU COULDN'T DO PLACEBO CONTROLLED TRIAL IN WEST AFRICA, ON EBOLA, THAT NO ONE WOULD VOLUNTEERS AND FOLLOW-UP WOULD BE POOR. WE HAD TO HAND OUT NUMBERS LIKE AT A DELI COUNTER BECAUSE WE HAD MORE VOLUNTEERS THAN WE COULD HANDLE. WE ENROLLED THIS STUDY IN AN AMAZINGLY SHORT PERIOD OF TIME. FOLLOW-UP WAS 98%-PLUS FOR EACH VISIT. AS WE WERE ENROLLING AND DOING WELL, IN LIBERIA SHOWN BY THE LIGHT BLUE LINES THE EPIDEMIC SUBSIDED AND IN FACT I THINK MANY ARE AWARE THEY HAVE GONE TWO 42-DAY PERIODS WITH ONE CLUSTER IN BETWEEN, NO NEW CASES IN LIBERIA ALLOWING ONE TO DO A CLINICAL ENDPOINT STUDY. WHAT WE DID WITH THE AGREEMENT OF THE DSMV, WE REDEVELOPED THE PLAN, CHANGED PROTOCOL DESIGNED, PLANNED TO MOVE TO GUINEA WHERE THEY WERE STILL CASES GOING ON BUT THE CASE NUMBERS DROPPED EVEN IN GUINEA, FROM 27,000 WE NEEDED TO GO TO A SAMPLE SIZE OF 156,000. WE DID HAVE THIS COHORT THAT WAS ENROLLING WELL IN LIBERIA. WE INVESTED SUBSTANTIALLY IN THE CLINICAL RESEARCH INFRASTRUCTURE IN LIBERIA AND SAID LET'S EXPAND THE PHASE 2, INCREASE THE FOLLOW-UP AND AMOUNT OF LABORATORY WORK. THAT 1500 PATIENT COHORT CONTINUES TO BE FOLLOWED, IN GUINEA THE CASES DID GO DOWN TO JUST A COUPLE WEEKS AND THE RING VACCINATION STUDY THAT W.H.O. IS DOING CAME UP WITH PRELIMINARY DATA SUGGESTING STRONGLY ANY SETTING OF POST EXPOSURE ADMINISTRATION THE VSV VACCINE, ONE OF THE TWO WE WERE TESTING, WAS QUITE EFFECTIVE IN PREVENTING EBOLA VIRUS INFECTIONS OCCURRING TEN DAYS OR MORE AFTER THE TIME OF ADMINISTRATION. I'M NOT GOING TO GO THROUGH THESE DATA OTHER THAN TO POINT OUT IN THE FIRST COLUMN WHICH IS THE PRIMARY ANALYSIS FROM THE STUDY, COMPARING EVERYONE WHO WAS VACCINATED IN THE IMMEDIATE ARM, SO THIS IS A GROUP OF CONTACTS, AND CONTACTS OF CONTACTS, WHO IMMEDIATELY GOT THE VSV COMPARED TO THE CONTACTS OF THE CONTACTINGS IN THE CONTROL ARM WHO DIDN'T GET THE VACCINE UNTIL 21 DAYS LATER. IF YOU COMPARE IMMEDIATE ARM TO THE CONTROL ARM, OR DELAYED ARM, THERE WAS NINE INFECTIONS IN THE IMMEDIATE -- DURING THE FIRST TEN DAYS VERSUS 16 IN THE DELAYED BUT GOING DOWN AFTER TEN DAYS NO INFECTIONS IN THE IMMEDIATE ARM COMPARED TO 16 IN THE DELAYED. AGAIN, WHEN YOU GO THROUGH THE METHODOLOGY, YOU CAN SEE THE COMPARISON HERE IS ALL VACCINATED IN THE ONE ARM, COMPARED TO ALL ELIGIBLE IN THE OTHER, AND THUS THERE ARE SOME CONFOUNDERS IN THERE THAT ARE STILL BEING WORKED THROUGH, BUT NONETHELESS PRETTY GOOD EVIDENCE THERE IS EFFICACY OF THIS PARTICULAR CANDIDATE. WHERE WE'RE GOING NEXT WITH THE VACCINES IN WEST AFRICA DEPENDS ON WHAT'S GOING ON IN THE EPIDEMIC, IF THERE'S PERSISTENT TRANSMISSION AND NEED AND OPPORTUNITY FOR EVALUATING EFFICACY IN A CLINICAL SCENARIO, WE WILL DO THAT AT A COMMUNITY-BASED LEVEL, PROBABLY IN THE CLINICAL ENDPOINT STUDY. IF WE GET TO ZERO NEW CASE THERE'S STILL QUESTIONS OF SAFETY AND IMMUNOGENICITY PARTICULARLY IN THE YOUNGER AGE GROUP SO A GENERAL POPULATION PHASE 2 STUDY MAY TAKE PLACE, WE'LL LOOK AT VSV, CHAMP AD-3 AND OTHER CANDIDATES, THE HUMAN AD-26 WITH A BOOST BEING DEVELOPED BY J & J. WE WORKED HARD OVER THE TIME TO VERY MANY THE INVESTIGATOR COMMUNITY IN THE THREE COUNTRIES AND WERE ABLE TO BRING THEM TOGETHER IN LIBERIA LAST MONTH TO TALK ABOUT THE FACT THAT IT WOULD BE GREAT TO WORK ACROSS THE THREE COUNTRIES WITH A COMMON PROTOCOL AND WE'RE HOPING THE NEXT PROTOCOL WILL BE OF THAT TYPE. TO SAY A FEW WORDS ABOUT TREATMENT, THE BASIC TREATMENT FOR PATIENTS WITH EBOLA IS SUPPORTIVE CARE, FLUID AND ELECTROLYTES, VENTILATOR SUPPORT, RENAL REPLACEMENT THERAPY. WE LEARNED FROM THE LIMITED NUMBER OF PATIENTS HERE AT THE CLINICAL CENTER WHAT WAS WRITTEN IN THE TEXT BOOKS AND WHAT WAS THE CASE WERE SO DIFFERENT AS TO BE EXTRAORDINARY. WHAT WOULD HAPPEN IN AFRICA WITH THE CASE OF EBOLA IS THE PATIENT WOULD GET SICK AND EITHER GET BETTER OR DIE, MINIMAL SUPPORT, MAYBE SOME FLUIDS. HERE IN THE U.S., ALSO IN EUROPE, HERE AT EMORY OR NEBRASKA, YOU MAINTAIN THE PATIENTS, BLOOD PRESSURE DOESN'T DROP, THEY STILL DEVELOP MULTI-SYSTEM ORGAN FAILURE, LUNGS, KIDNEY, NERVOUS SYSTEM, AND EXTRAORDINARY INFECTION SEEING EVEN A COUPLE PATIENTS HERE ENHANCED OUR KNOWLEDGE EXTRAORDINARILY. THERE ARE A EVALUATOR OF EXPERIMENTAL ANTI-VIRAL STRATEGIES DEVELOPED PRIOR TO THE OUTBREAK IN ANIMAL MODELS, ANTIBODIES THAT NEUTRALIZE, PROMOTE ADCC, SMALL MOLECULES AND POLYMERASE AND TRANSCRIPTION. ZMapp COCKTAIL BINDS TO THREE REGIONS. ENVELOPE GLYCOPROTEIN. THE SURVIVAL IN THE NON-HUMAN PRIMATES IS 99%+, 100% MORTALITY IN THE CONTROL ARM. UNFORTUNATELY, WE DON'T HAVE SURROGATE MARKERS FOR EBOLA VIRUS INFECTION, BECAUSE OF THE HIGH MORTALITY THOUGH IN EBOLA WE'RE ABLE TO DO A CLINICAL ENDPOINT STUDY WITH SURVIVAL AS THE PRIMARY OUTCOME. HISTORICAL CONTROLS WHICH MANY HAVE SAID SHOULD BE USED IN THESE STUDIES BECAUSE YOU CAN'T DO RANDOMIZATION HAS THE POTENTIAL TO BE VERY MISLEADING AS ILLUSTRATED HERE, JUST LOOKING AT THE BOTTOM THREE ROWS, DECLINE AT MORTALITY AT ONE SITE IN SIERRA LEONE AS OUTBREAK INVOLVED FROM SEPTEMBER OF 2014 TO OCTOBER OF 2014 TO NOVEMBER OF 2014, SO AGAIN WE FELT IT IMPORTANT TO STUDY THESE THINGS IN A ROBUST WAY, THERE WAS A LOT OF OFF LABEL INVESTIGATIONAL SINGLE PATIENT EXEMPTION WORK GOING ON. ALL WE SAW COMING OUT WERE A SERIES OF ANECDOTES AND WORRIES ABOUT PATIENT SAFETY. WORKING WITH FDA, RICK DAVEY, LORI DODD AND NIAID CAME UP WITH A NOVEL ADAPTIVE TRIAL DESIGN TO LOOK AT TREATMENT FOR EBOLA DISEASE WHICH COULD BE APPLIED TO ANY DISEASE WHERE YOU WANT TO LOOK QUICKLY AT MULTIPLE INTERVENTIONS OR ONE. THE SUPPORTIVE CARE IS THE CONTROL ARM. INVESTIGATOR DRUG A IS ZMapp F WE SHOW THIS TO BE OF BENEFIT WE MAY THEN GO AND LOOK AT OTHER AGENTS BUT RIGHT NOW WE'RE JUST ENROLLING IN A RANDOMIZED CONTROL TRIAL OF ZMapp PLUS STANDARD OF CARE VERSUS STANDARD OF CARE. THAT STUDY HAS 65 PATIENTS ENROLLED, WE'RE ABLE TO ENROLL MOST NEW SPORADIC CASES. DATA BEING LOOKED AT FREQUENTLY BY A DSMV. THIS WAS AN OPPORTUNITY TO STAND WHAT WE WERE DOING HERE, THE SAME STUDY TO LIBERIA, FROM THERE TO SIERRA LEONE, FROM THERE TO GUINEA. THIS IS A TEAM IN SIERRA LEONE THAT TOOK OVER THE BUSINESS CENTER AT THE RADISSON HOTEL, THIS IS THE PHARMACY AREA AT PTS 1 HOSPITAL IN FREETOWN, DIFFERENT THAN THE CLINICAL PHARMACY. AND ONE OF THE GRATIFYING MOMENTS TO PARTICIPATE IN ONE OF THE CEREMONIES WHERE A SURVIVOR OF EBOLA WHO HAD BEEN A PARTICIPANT WAS DISCHARGED WITH A CERTIFICATE SAYING SHE WAS NEGATIVE AND THESE BECAME EMOTIONAL EVENTS. THE FINAL THING IS WITH INFRASTRUCTURE WE PUT INTO LIBERIA WE LAUNCHED A NATURAL HISTORY STUDY OF SURVIVORS, BOTH P.I.s ARE HELPED BY LIBBY HIGGS. RACHEL IS LEADING AN EYE STUDYA AVI NATH NEUROLOGY SUBSTUDY, THREE SITES OPEN, WE HOPE TO ENROLL 1500 SURVIVORS. THIS IS SHOWING THE CONSENT PROCESS AT JOHN F. KENNEDY MEDICAL CENTER IN LIBERIA, MOSAKA FALLAH ON THE LEFT, LAURA McNAY. WORKING WITH RACHEL WE BROUGHT IN EYE EQUIPMENT, NOWHERE TO BE FOUND IN LIBERIA AT THE TIME, AND ARE DOING EXTENSIVE EYE EXAMS. UVITIS IS A SEQUELAE, AND WE'RE DOING ROUTINE MONITORING, THE CLINICAL CENTER LABORATORY HAS BEEN HEPFUL TO US BEING ABLE TO DO THIS. WE'VE ENROLLED 640 SURVIVORS THUS FAR, 73 CONTACTS, I DRAW YOUR ATTENTION TO THE GAP, MALARIA, 80% OF SURVIVORS HAVE HAD MALARIA, 100% OF OUR CONTROLS, 6% OF THE SURVIVORS HAVE HAD SYPHILIS OR ANOTHER STE, STD, 16% OF CONTROLS, NO ONE GIVES A HISTORY OF HIV/AIDS, WE KNOW FROM THE PREVAIL ONE VACCINE TRIAL COHORT PROBABLY 5 TO 10% OF THIS COHORT IS INFECTED WITH HIV AND JUST DON'T KNOW IT. THE SUMMARY THEN, THE MISSION HERE FOR US HEAVILY INTRAMURAL HAS BEEN TO BUILD CLINICAL RESEARCH PROGRAMS IN ACCORDANCE WITH HIGH SCIENTIFIC OPERATION AND ETHICAL STANDARDS AND BY EXTENSION SUPPORT THE HEALTHCARE SYSTEMS IN THOSE AREAS. WE'VE DONE OUR BEST TO DO THINGS IN A RIGOROUS FASHION, FROM THE BEGINNING TO ENSURE WE LEAVE THE EPIDEMIC WITH MORE KNOWLEDGE THAN WHEN WE ENTERED. WORKING HARD TO COORDINATE WHAT WE'VE BEEN DOING WITH THE OTHER AGENCIES AND MINISTRIES IN THE COUNTRIES WE'RE WORKING IN TO MAKE SURE THAT THE MOST SCIENTIFICALLY SOUND STUDIES WITH THE GREATEST POTENTIAL IMPACT ARE GIVEN PRIORITY. THANKS VERY MUCH. [APPLAUSE] >> WE HAVE TIME FOR A COUPLE QUESTIONS. OKAY, THANK YOU. OUR NEXT SPEAKER IS PAMELA COLLINS. DR. COLLINS IS A ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS, AND DIRECTOR OF THE OFFICES FOR SPECIAL POPULATIONS, RURAL MENTAL HEALTH RESEARCH AND GLOBAL MENTAL HEALTH. HER EARLY RESEARCH WAS ON THE PSYCHIATRIC EFFECTS OF HIV INFECTION, AND AVAILABILITY OF MENTAL HEALTH SERVICES FOR PEOPLE WHO WERE HIV INFECTED, BOTH DOMESTICALLY AND INTERNATIONALLY. SHE NOW FOCUSES ON DISPARITIES IN MENTAL HEALTH INSIDE AND OUTSIDE OF THE U.S. AND SHE POINTS OUT THAT THIS IS A HIDDEN EPIDEMIC, MENTAL DISORDERS ARE THE LEADING CAUSE OF DISABILITY AROUND THE WORLD, AND VERY LITTLE QUITE RECENTLY HAS BEEN DONE TO REMEDY THIS. DR. COLLINS RECEIVED HER MEDICAL DEGREE FROM CORNELL UNIVERSITY MEDICAL COLLEGE, M.PH. FROM COLUMBIA, THE TITLE IS THE ENORMOUS GLOBAL BURDEN OF MENTAL ILLNESS. >> THANK YOU VERY MUCH. CAN YOU HEAR ME? IS THAT GOOD? OKAY. THANKS SO MUCH. MY PERSPECTIVE WILL BE A LITTLE BIT DIFFERENT BECAUSE I'M COMING FROM THE EXTRAMURAL WORLD AT NIMH FROM THE OFFICE FOR RESEARCH ON DISPARITIES IN GLOBAL MENTAL HEALTH, HOW DO WE ADDRESS DISPARITIES THROUGH RESEARCH, BOTH LOCALLY AND GLOBALLY. JUST TO FOLLOW ON CLIFF'S PRESENTATION, IN MARCH OF 2015 SARAH RIORDAN WROTE IN AN ISSUE OF "NATURE" THE EBOLA EPIDEMIC IN WEST AFRICA MAY BE FADING, BUT ITS IMPACT ON MENTAL HEALTH COULD LINGER FOR YEARS. SURVIVORS ARE OFTEN HAUNTED BY TRAUMATIC MEMORIES, AND THEY FACE REJECTION BY SOCIETY WHEN THEY RETURN HOME. THOSE WHO NEVER CONTRACTED THE DISEASE MAY GRIEVE FOR LOST RELATIVES OR STRUGGLE TO COPE WITH EXTREME ANXIETY. AID GROUPS AND GOVERNMENTS ARE BATTLING TO ADDRESS THE SITUATION, IN A REGION THAT HAS LITTLE IN TERMS OF MENTAL HEALTH INFRASTRUCTURE. BUT THE FEAR AND THE DISTRUST OF AUTHORITIES THAT HELPED EBOLA TO SPREAD ALSO MAKE IT DIFFICULT TO MANAGE THE TOLL ON MENTAL HEALTH. IN MEASURES SUCH AS QUARANTINES CAN LIMIT ACCESS TO NECESSARY TREATMENT. THIS STORY HIGHLIGHTS THE ENDURING CHALLENGES OF CARING FOR PEOPLE WITH MENTAL DISORDERS AROUND THE WORLD. FREQUENTLY, THE MENTAL HEALTH INFRASTRUCTURE IN COUNTRIES OF NON-EXISTENT OR QUITE WEAK, AND THIS LEADS TO A DELAY IN ACCESS AND CARE, DELAYING TREATMENT CAN INCREASE LIKELIHOOD OF DISABILITIES. AND WE'RE SEEING THESE KINDS OF IMAGES EVERY DAY THAT WOULD SUGGEST PEOPLE'S LIVES THAT ARE AFFECTED BY CONFLICT WOULD SUGGEST WE'LL BE SEEING MORE OF THESE KINDS OF PROBLEMS. THESE ARE PEOPLE WHO ARE LIKELY TO HAVE BEEN REPEATEDLY EXPOSED TO TRAUMA AND HAVE A GREATER LIKELIHOOD OF DEVELOPING MENTAL DISORDER. BUT I ALSO WANT TO EMPHASIZE THAT MENTAL DISORDERS EMERGE IN PEOPLE OF COURSE IN THE ABSENCE OF SOCIAL UPHEAVAL AND WE DON'T FULLY UNDERSTAND HOW THE NUMEROUS DISTAL RISK FACTORS INTERACT TO END UP TO GIVE US THE SYMPTOMS OF DISORDERS. SO THOSE RISK FACTORS INCLUDE OBVIOUSLY OUR GENES, OUR FAMILY HISTORY, EARLY CHILDHOOD ADVERSITY, IMMIGRATION, SOCIAL EXPERIENCES, LOSS, AND OF COURSE ENVIRONMENT MEANING THE MANY EXPOSURES THAT HAPPEN IN ENVIRONMENT, INCLUDING WAR, EPIDEMICS AND OTHER KINDS OF DEPRIVATION. THE KINDS OF DISORDERS THAT I'LL BE TALKING ABOUT IN TERMS OF THE INTERVENTIONS THAT WE'RE SUPPORTING TO DEVELOP ARE THINGS LIKE MAJOR DEPRESSIVE DISORDER, OTHER MOOD DISORDERS LIKE BIPOLAR, PSYCHOSIS, INCLUDING SCHIZOPHRENIA, ET CETERA. I WANT TO TALK ABOUT WHAT WE KNOW ABOUT THE DISTRIBUTION OF THE BURDEN OF ILLNESS AROUND MENTAL DISORDERS GLOBALLY, AND I'LL SAY SOMETHING ABOUT RESOURCES TO ACTUALLY MANAGE THESE PROBLEMS. THEN I'LL END BY TALKING ABOUT SOME OF THE INTERVENTIONS THAT SHOW PROMISE AND THAT NIMH IS SUPPORTING AS WELL. AND ONE OF THE MESSAGES I WANT TO CONVEY IS THAT IN ORDER TO RESPOND IN THE CONTEXT OF EMERGENCY SETTINGS, WE HAVE TO FIGURE OUT HOW TO BUILD THAT INFRASTRUCTURE AND ENSURE THAT PEOPLE CAN DELIVER THE EVIDENCE-BASED INTERVENTIONS WE KNOW CAN BE EFFECTIVE. SO THIS IS A MAP JUST SHOWING YOU THE DISTRIBUTION OF DISABILITY ADJUSTED LIFE YEARS FOR MENTAL DISORDER, THE BURDEN FROM 2010 DATA, AND THE EASY WAY TO LOOK AT THIS SLIDE IS SAY THE PINK ONES, THE PALE COUNTRIES, REPRESENT THE MEDIAN, THE MEAN. THESE ARE THE COUNTRIES THAT ARE IN THE MIDDLE. RED COUNTRIES ARE HIGHER THAN THE MIDDLE. YOU CAN SEE FOR EXAMPLE -- LET ME SEE IF I HAVE A POINTER HERE. THIS IS LIBYA, COUNTRIES THAT ARE EXPERIENCING A LOT OF ADVERSITY ARE OFTEN SOME OF THE DARKERS COUNTRIES BUT AGAIN THE UNITED STATES IS ONE OF THE DARKER COUNTRIES AS WELL AND BLUE REPRESENTS THOSE WHO HAVE LESS THAN THE MEAN IN TERMS OF DISABILITY ADJUSTED LIFE YEARS. CHINA AND NIGERIA ARE TWO OF THOSE. AGAIN, IT'S ALWAYS IMPORTANT TO NOTE THAT THESE ARE DISORDERS THAT OCCUR EVERYWHERE, AND THIS IS AN IMAGE SHOWING REGIONS OF THE WORLD, SUB-SAHARAN AFRICA, LATIN AMERICA, EUROPE, ASIA, AND WHAT YOU CAN TAKE AWAY ARE THESE ARE DIFFERENT DISORDERS. BLUE IS DEPRESSIVE, HIGHLY PREVALENT AND HIGHLY DISABLING, SO TENDS TO REPRESENT MOST OF THE DALYs, BUT THE TAKEAWAYS OF THESE DISORDERS ARE EVERYWHERE. IS THAT ME OR IS THAT SOMETHING ELSE? OKAY. THESE DISORDERS ARE HAPPENING EVERYWHERE. THE RED REPRESENTS ANXIETY DISORDERS, ALSO A VERY COMMON MENTAL DISORDER. AND WHAT WE'VE NOTICED WHEN YOU'RE LOOKING AT THE GLOBAL BURDEN OF DISEASE STUDIES, ONE OF THE PROBLEMS THAT HAS CHANGED SIGNIFICANTLY OVER THE LAST 20 YEARS IS ACTUALLY SUBSTANCE USE DISORDERS, INCREDIBLE INCREASES AROUND THE WORLD. AND UNLIKE MOST NON-COMMUNICABLE DISEASES THESE ARE ACTUALLY DISABLING DISORDERS OF YOUNG PEOPLE, AND AGAIN LOOKING AT AGE GROUPS, THIS IS AGE 5, GOING UP TO AGE 80, THE BULK ARE AFFECTING PEOPLE IN THEIR YOUTH, ABOUT 50% BEGIN BEFORE THE AGE OF 15, AND ABOUT 75% BEFORE THE AGE OF 24. SO HIGHLY DISABLING, AFFECTING PEOPLE WHEN THEY ARE GETTING THEIR EDUCATION, BEGINNING THEIR WORK, WHEN THEY ARE STARTING FAMILIES, ET CETERA. BUT THEY ARE NOT ONLY DISABLING. THESE ARE ALSO DEADLY DISEASES. THERE ARE ABOUT 800,000 SUICIDES A YEAR. THE BULK OF THEM OCCUR IN LOW AND MIDDLE INCOME COUNTRIES BECAUSE OF THE HIGH POPULATIONS IN LOW AND MIDDLE INCOME POPULATIONS, EVEN THOUGH RATES ARE HIGHER IN HIGH INCOME COUNTRIES. AGAIN, IN THIS IMAGE, THE DARKEST COUNTRIES ARE THOSE WITH THE HIGHEST SUICIDE RATES, AND AS YOU GET PALER YOU HAVE LOWER SUICIDE RATES. SUICIDE IS AN INCREDIBLE PROBLEM, AND 90% TEND TO BE ASSOCIATED WITH MENTAL DISORDER. EVEN MORE SURPRISING IS DATA THAT WE'VE GATHERED OVER THE LAST 20 YEARS COMING FROM MANY STUDIES, SIMPLY LOOKING AT MORTALITY RATES IN PEOPLE WITH MENTAL DISORDERS. AND THIS WAS A LOVELY REVIEW PUBLISHED IN JAMA EARLIER THIS YEAR, WHICH LOOKED AT ABOUT 29 STUDIES FROM SIX DIFFERENT CONTINENTS. I'M SORRY, 150 STUDIES ON SIX CONTINENTS, AND EXAMINED MORTALITY ASSOCIATED WITH ROUTINE CAUSES OF DEATH, NOT NECESSARILY SUICIDE. MORTALITY FOR PEOPLE WITH THE MENTAL ILLNESS IS TWICE THAT OF THE GENERAL POPULATION. IT'S HIGHER FOR PEOPLE WITH PSYCHOSIS COMPARED TO PEOPLE WITH DEPRESSION AND ANXIETY BUT EVEN WITH THOSE OTHER DISORDERS YOU STILL SEE AN ELEVATED MORTALITY. MANY OF THESE ARE DEATHS FROM NON-COMMUNICABLE DISEASE, ON AVERAGE REDUCING LONGEVITY BY TEN YEARS. WHEN YOU FACTOR IN THESE DEATHS, ABOUT 8 MILLION DEATH AS YEAR CAN BE ATTRIBUTED TO MENTAL DISORDERS. SO WHAT CAN ONE DO ABOUT THESE? THIS IS FROM THE LATEST DATA FROM W.H.O.'S MENTAL HEALTH ATLAS THAT SHOWS ABOUT HOW MUCH MONEY COUNTRIES ARE SPENDING PER CAPITA FOR -- IN U.S. DOLLARS FOR MENTAL HEALTH SERVICES, AND THE LOWEST INCOME COUNTRIES ARE SPENDING ABOUT $1.53 A YEAR PER CAPITA, OBVIOUSLY A HUGE DIFFERENCE FROM THE HIGHEST INCOME COUNTRIES. SOMEONE MIGHT IMAGINE WHY THIS GRAPH LOOKS SIMILAR IN TERMS OF HUMAN RESOURCES, WHERE IN THE LOWEST INCOME COUNTRIES YOU HAVE LESS THAN ONE PROVIDER PER 100,000 PEOPLE, COMPARED WITH UP TO 50-SOMETHING PROVIDERS IN HIGH INCOME COUNTRIES. THERE'S SOME MODELING OF WHAT THIS MEANS IN TERMS OF NEEDING TO DEVELOP A MENTAL HEALTH WORKFORCE IN SUB-SAHARAN AFRICA, FOR EXAMPLE, ONE COULD EXPECT ABOUT 130% INCREASE IN DISEASE BURDEN BY 2050, WHERE YOU ALREADY HAVE DEFICITS IN ADDITIONAL 216,000 MENTAL HEALTH CARE PROVIDERS WOULD BE NEEDED OVER THE NEXT 35 YEARS. AND SO WHAT HAPPENS WHEN YOU DON'T HAVE THOSE PROVIDERS? THIS IS AN IMAGE FROM A FIELD VISIT WE RECENTLY MADE IN GHANA. THIS IS AT A PRAYER CAMP, AN EXAMPLE OF WHERE PEOPLE WITH MENTAL ILLNESS ARE TREATED. YOU CAN SEE THE LITTLE CELLS THAT INDIVIDUAL PATIENTS RESIDE IN. AND THIS IS WHAT PEOPLE DO WHEN THEY DON'T HAVE SERVICES. THEY FIGURE OUT HOW TO MAKE DO. IN THIS CONTEXT THERE ARE MORE BEDS IN THESE KINDS OF FACILITY THAN THE MINISTRY OF HEALTH, THIS IS WHY FAMILIES SEND FAMILY MEMBERS TO THESE SETTINGS, WHAT'S AVAILABLE MOST READILY. I WANT TO POINT OUT THE UNITED STATES IS OPERATING ON A DIFFERENT SCALE. IF YOU LOOK AT THE YELLOW SPOTS ON THIS MAP, THOSE ARE THE ONLY PLACES WE HAVE ADEQUATE NUMBERS OF MENTAL HEALTH CARE PROVIDERS IN THE U.S. AND AGAIN THIS IS THE STORY THAT'S BEEN FOLLOWED IN THE "NEW YORK TIMES" EMPHASIZING HOW MANY PSYCHIATRIC PATIENTS ARE BEING TREATED IN JAILS IN THIS COUNTRY. SO WHAT ABOUT RESOURCES FOR INTERVENTIONS OR WHAT DO WE DO FOR INTERVENTIONS IN THESE LOW RESOURCE SETTINGS? THERE'S BEEN WONDERFUL EVIDENCE ACCUMULATING ABOUT TAX SHIFTING, USING LESS SPECIALIZED PROVIDERS TO DELIVER SERVICESES FOR -- DELIVER EVIDENCE-BASED INTERVENTION FOR MENTAL HEALTH. MOST HAVE BEEN AROUND DEPRESSION CARE, MOST ARE PSYCHOLOGICAL INTERVENTIONS, BUT WE HAVE SOME VERY NICE DATA FROM INDIA, FROM PAKISTAN, FROM UGANDA, CHILE, AND EVEN MORE IS ACCUMULATING. BUT I THINK WHAT'S ALSO ENCOURAGING, THIS IS A STUDY THAT JUDY BASS PUBLISHED IN THE NEW ENGLAND JOURNAL A COUPLE YEARS AGO, WE'RE SEEING DATA THAT SHOW EVEN IN PLACES THAT ARE FRAGILE, THIS IS A STUDY DONE IN THE DEMOCRATIC REPUBLICAN OF THE CONGO, YOU CAN STILL GET THIS WORK DONE. AND THEY ESSENTIALLY TRAINED PSYCHOSOCIAL ASSISTANTS WORKING WITH N.G.O.s IN THE REGION PROVIDING SOCIAL SUPPORT BUT THEY TRAINED THEM TO PROVIDE A SPECIFIC TYPE OF PSYCHOTHERAPY COMPARED TO -- AND COMPARE THIS TO JUST ROUTINE SUPPORT. WHAT THEY FOUND WAS THAT THIS STRUCTURED PROBLEM SOLVINGTHERAPY WAS EFFECTIVE FOR PREEDING DEPRESSIVE AND ANXIETY SYMPTOMS AND REDUCING PTSD SYMPTOMS OVER SIX MONTHS, USING LOCAL RESOURCES FOR CARE IN A POORLY RESOURCED SETTING BUT ABLE TO GET GOOD OUTCOMES. I WANT TO TELL YOU ABOUT ONE OF OUR INITIATIVES AT NIMH THAT'S BEEN HOPING TO BUILD EVIDENCE ON SIMILAR KINDS OF PROBLEMS. THESE ARE THE COLLABORATIVE HUBS FOR INTERNATIONAL RESEARCH ON MENTAL HEALTH. IN 2010, I THINK IT WAS, WE BROUGHT TOGETHER A SMALL GROUP OF FOLKS TO HELP US THINK THROUGH WHAT WERE SOME OF THE PRESSING ISSUES AROUND THE GLOBE WITH RESPECT TO MENTAL HEALTH AND HOW COULD RESEARCH SOLVE THESE PROBLEMS. WE'RE TALKING TO PEOPLE FROM MINISTRIES OF HEALTH, PATIENTS, RESEARCHERS WHO WERE CONDUCTING MENTAL HEALTH SERVICES RESEARCH IN THESE SETTINGS, N.G.O.s WORKING GLOBALLY, AND ONE OF THE BIG ISSUES THAT PEOPLE TALKED ABOUT WAS NEEDING TO MAKE SURE THE RESEARCH WAS ACTUALLY MEETING NEEDS OF END USERS, OFTEN, YOU KNOW, IN OUR FIELD THERE ARE BIG TRIALS THAT MAY HAVE BEEN PUBLISHED BUT NO ONE'S UTILIZING THOSE RESULTS AND THEY ARE NOT FEEDING INTO THE PUBLIC HEALTH SYSTEM. SO AFTER THE CONVERSATION WE THOUGHT ABOUT A FEW THINGS. WE THOUGHT, WELL, GIVEN THE RESOURCE ISSUES AND DISPARITIES THAT I JUST SHOWED YOU, RESOURCES ACROSS COUNTRIES, ONE OF THE THINGS WE COULD DO IS FIGURE OUT WHAT WE CAN DO TO REDUCE THE TREATMENT GAP, THE NUMBER OF -- DIFFERENCE BETWEEN PEOPLE WHO NEED TREATMENT AND GET ACCESS TO TREATMENT AND DO THAT BY STRENGTHENING THE EVIDENCE BASE ON TASK SHIFTING, FIGURING OUT WHAT ARE THE VARIOUS KINDS OF PROVIDERS IN THESE DIFFERENT HEALTH SYSTEM CONTEXTS WHO MIGHT BE ABLE TO DELIVER EVIDENCE-BASED MENTAL HEALTH SERVICES. THAT WAS ONE. THAT WAS A RESEARCH QUESTION. THE OTHER PIECE WAS TO STRENGTHEN RESEARCH CAPACITY AS WE DID THIS, AS THESE GROUPS SET ABOUT DOING THESE TRIALS, HOW COULD THEY BUILD RESEARCH CAPACITY BUT NOT JUST FOR THEIR UNIVERSITY OR THEIR COUNTRY BUT FOR A REGION. THE THIRD THING WE WANTED TO MAKE SURE WAS THAT THERE WERE MEANINGFUL COLLABORATIONS IN THESE RESEARCH TEAMS. ONE REQUIREMENT WAS THAT THEY HAD TO DEMONSTRATE THAT THEY HAD GOVERNMENT BUY-IN, THEY WERE WORKING WITH LOCAL CLINICIANS AND GETTING THE VIEWPOINTS OF LOCAL SERVICE USERS AS WELL AS HAVING AN ADEQUATE RESEARCH TEAM TO ANSWER THESE QUESTIONS. SO THIS ISSUE OF COLLABORATION AND FIGURING OUT HOW YOU COULD LOAD IT UP FRONT SUCH THAT YOU WOULD HAVE A GREATER LIKELIHOOD OF PUBLIC HEALTH IMPACT SHOULD THE FINDINGS BE POSITIVE. AND FINALLY, WE WANTED TO CREATE A NETWORK OF STUDIES THAT COULD ACTUALLY ASK QUESTIONS ACROSS THIS DIVERSE SET OF HEALTH SYSTEMS, AND SEE WHAT THEY COULD DO TOGETHER. SO WE FUNDED FIVE OF THESE HUBS, AND I'LL GO THROUGH EACH ONE OF THEM BRIEFLY. THE PARTNERSHIP FOR MENTAL HEALTH AND DEVELOPMENT, SUB-SAHARAN AFRICA, IS BASED IN GHANA, AND NIGERIA, LIBERIA, KENYA, SOUTH AFRICA. THEY ARE DOING TRIALS IN NIGERIA AND GHANA GET, OR GETTING READY TO ON, THEY ARE INTERESTED IN FIGURING OUT HOW TO EXPAND SERVICES FOR PEOPLE WITH PSYCHOSIS. THESE ARE TWO OF THE SITES WHERE YOU HAVE MORE PEOPLE SEEKING CARE FROM TRADITIONAL HEALERS OR FAITH HEALERS THAN THROUGH THE REGULAR HEALTH SERVICE SIMPLY BECAUSE OF THE DEARTH OF PROVIDERS. SO THEY ARE GOING TO TRY TO FIGURE OUT HOW YOU CAN WORK WITH THESE COMPLEMENTARY PROVIDERS. THIS TEAM IS BASED OUT OF UNIVERSITY OF CAPETOWN, ALSO WORKING IN ETHIOPIA, UGANDA, MALAWI AND GHANA. IN A DISTRICT WHERE THERE WERE TWO PSYCHIATRIC NURSES THAT ESSENTIALLY HAD TO HANDLE EVERYONE IN THAT ENTIRE DISTRICT WHO HAD A PSYCHIATRIC PROBLEM, THEY ARE NOW TRYING TO SEE CAN YOU ACTUALLY WORK WITH THE PRIMARY CARE PROVIDERS AT SMALLER HEALTH CENTERS AND EQUIP THEM TO MANAGE PEOPLE WITH PSYCHOSIS. IN SOUTH AFRICA THIS GROUP IN WORKING IN THE TOWNSHIP OF KYLETA TO CHAIN WORKERS TO DEAL WITH MATERNAL DEPRESSION IN CHILD CARE SETTINGS. THESE ARE UNDERWAY AND WE'LL SEE WHAT COMES OUT OF THOSE. LATIN-AMERICAN TREATMENT AND INNOVATION NETWORK IN MENTAL HEALTH IS ONE OF OUR TWO LATIN-AMERICAN HUBS, AND THIS IS DIFFERENT, DIFFERENT IN PART BECAUSE THESE ARE WORKING IN MIDDLE INCOME COUNTRIES, AND THE QUESTION THAT THEY ARE ASKING IS HOW DO WE DEAL WITH THE COMORBIDITIES OF DEPRESSION, FOR EXAMPLE, AND OTHER NON-COMMUNICABLE DISEASES LIKE HYPERTENSION AND DIABETES? AND THEY ARE VEALING AN APP THAT PATIENTS CAN USE TO BOTH MONITOR THEIR MENTAL HEALTH AND IF THEY HAVE DEPRESSIVE SYMPTOMS GO THROUGH A COGNITIVE BEHAVIORALLY ORIENTED APP THAT WILL HOPEFULLY LEAD TO GOOD OUTCOMES. SO THEY ARE WORKING BOTH WITH PEOPLE WITH COMORBIDITIES AS WELL AS NURSES TO SEE IF THEY CAN MANAGE CARE FOR BOTH OF THESE KINDS OF PROBLEMS. AND FINALLY, ALMOST FINALLY, REDEAMERICAS IS FOCUSING ON IMPROVING THE LIVES OF PEOPLE WITH PSYCHOSIS, FIGURING OUT HOW DO WE USE PEERS TO WORK WITH PEOPLE COMING INTO A CLINIC, NEW ADMISSIONS TO OUTPATIENT SERVICES, TO HELP NAVIGATE THEM THROUGH TREATMENT BUT ALSO ENSURING THAT THEY GET NAVIGATION TO MEDICAL SERVICES. I MENTIONED THE ISSUES AROUND MORTALITY, ENSURING PEOPLE HAVE GOOD MEDICAL CARE, ALONG WITH GOOD MENTAL HEALTH CARE IS INCREDIBLY IMPORTANT. THOSE TRIALS ARE HAPPENING IN BRAZIL AND CHILE. FINALLY, THE ONE HUB WE HAVE IN ASIA IS THE SOUTH ASIAN HUB FOR ADVOCACY RESEARCH AND EDUCATION ON MENTAL HEALTH. THAT'S INVOLVING INDIA, PAKISTAN, AFGHANISTAN, NEPAL, BANGLADESH AND SRI LANKA. TRIALS HAPPENING IN INDIA AND PAKISTAN, AGAIN THIS IS A GROUP THAT'S ALSO FOCUSING ON MATERNAL DEPRESSION. INTERESTINGLY, JUST BECAUSE OF THE LOCATION OF THESE STUDIES, YOU KNOW, THESE ARE ALSO COUNTRIES THAT HAVE HAD A NUMBER OF SOCIAL UPHEAVALS AND SO IN ADDITION TO SIMPLY ROUTINE MANAGEMENT OF DEPRESSION THE TEAMS ARE FIGURING OUT HOW TO DEAL WITH POST CONFLICT, POST NATURAL DISASTER, THIS SORT OF THING. SO THIS IS AN EXAMPLE OF MOTHERS, WOMEN, WHO MAY OR MAY NOT HAVE HAD A PREVIOUS EPISODE OF DEPRESSION, WHO ARE BEING TRAINED TO DELIVER A SIMPLE COGNITIVE BEHAVIORAL THERAPY INTERVENTION TO OTHER DEPRESSED MOTHERS. AND THIS IS THE THINKING HEALTHY PROGRAM WHICH ACTUALLY HAS BEEN USED QUITE WIDELY AROUND THE WORLD, NOW BECOME ONE OF W.H.O.'S MAIN THERAPY INTERVENTIONS PROMOTING FOR MANY SITES. WE'RE VERY EXCITED ABOUT THIS. AND SO THAT'S WHAT THESE COLLABORATIVE HUBS ARE DOING. IN THE MEANWHILE AS A NETWORK, THEY ARE WORKING TOGETHER ON A SHARED PROJECT THAT WILL FOCUS ON UNDERSTANDING MORE IN DEPTH HOW THIS TASK SHIFTING CAN WORK IN DIFFERENT CONTEXTS AND WHAT ARE THE TOOLS THAT HEALTH SYSTEMS NEED TO UTILIZE AS THEY THINK ABOUT HOW TO IMPLEMENT DIFFERENT KINDS OF TASK SHIFTING FOR DELIVERY OF SERVICES. AND FINALLY, WE ALSO TRY TO THINK ABOUT WHAT ARE THE WAYS THAT WE CAN STRETCH THE RESULTS OF RESEARCH THAT HAS BROADER IMPACT AND WE'VE DONE THAT THROUGH GETTING INVOLVED WITH THE NUMBER OF ACTIVITIES, ONE EXAMPLE, I'LL HIGHLIGHT A COUPLE, THE WHO ARE THE WORLD HEALTH ORGANIZATION DEVELOPED A PLAN TO IMPROVE ACCESS TO CARE AND IMPROVE ACCESS TO COMMUNITY CARE, IN PARTICULAR, REDUCING THE LONG-TERM STAY BEDS IN COUNTRIES, BUT THIS IS ALL -- THESE KINDS OF PLANS ARE BUILT ON THE EVIDENCE BASE SO WE'RE ALWAYS PROUD TO BE ABLE TO CONTRIBUTE TO THESE KINDS OF EFFORTS. I'LL HIGHLIGHT ONE LAST THING ON THIS PAIN, WHICH IS THAT IN APRIL OF 2016 THE WORLD BANK WILL BE HOLDING A MEETING THAT WILL BRING ATTENTIONING TO MENTAL HEALTH, TO USE RESEARCH FINDING TO COMMUNICATE WHAT WE KNOW ABOUT MENTAL HEALTH INTERVENTION TO A GROUP OF NON-MEDICAL PEOPLE, TO A GROUP OF FINANCE MINISTERS, TO SEE HOW THEY CAN TAKE THAT AND USE THAT BENEFICIALLY FOR THEIR POPULATION, AND WITH THAT I WILL STOP. THANK YOU. [APPLAUSE] >> QUESTIONS FOR DR. COLLINS? LET ME POSE ONE QUESTION, THERE MAY NOT BE A SIMPLE ANSWER. MANY OF THE OTHER PEOPLE WHO ARE SPEAKING AT NIH INTRAMURAL RESEARCH FESTIVAL ARE TALKING ABOUT INTRAMURAL CONTRIBUTIONS TO LARGE PROBLEMS. IS THERE A ROLE FOR THE INTRAMURAL PROBLEM? HAS NIMH THOUGHT ABOUT USING THE INTRAMURAL PROGRAM IN SOME WAY TO ADDRESS SOME OF THE ISSUES THAT ARE ON YOUR MIND? >> WELL, ACTUALLY I WAS JUST TALKING TO CLIFF LANE, WHO I THINK HAS BEEN TALKING TO SOME OF OUR INTRAMURAL COLLEAGUES ABOUT HOW THEY CAN HELP WITH EFFORTS AROUND EBOLA, FOR EXAMPLE, ON THE GROUND IN LIBERIA. SO CERTAINLY I THINK BEING ABLE TO -- IF YOU TALK TO THE -- SOME OF MY COLLEAGUES I'VE KNOWN OVER THE YEARS ARE WORKING AROUND EBOLA, FOR EXAMPLE, TO TAKE THIS EXAMPLE, AND I WOULD SAY ONE OF THE NEEDS RIGHT NOW THAT I'VE HEARD IS EVEN HAVING PEOPLE THAT CAN COME AND NOT PROVIDE DIRECT CLINICAL SERVICES BUT SUPERVISE THE PSYCHIATRIC NURSES ON THE GROUND WHO HAVE BEEN TAKEN AWAY FROM MAYBE DEALING WITH THE ROUTINE MENTAL HEALTH PROBLEMS TO NOW TRYING TO FOLLOW UP ON FAMILIES OF SURVIVORS WHO ARE DOING A LOT OF THINGS BUT OBVIOUSLY THESE ARE STRESSFUL JOBS THAT HAVE TAKEN ON IN THE CONTEXT OF AVAILABLE, HOW MANY PEOPLE HAVE EXPERIENCE COULD SUPERVISE, SOME COULD HAPPEN BY DISTANCE, BUT HAVING THAT ON THE GROUND CONTACT IS PROBABLY EVEN MORE BENEFICIAL. >> ALSO EMPHASIZING THE TRANS-NIH NATURE AND BENEFITS OF TEAM SCIENCE. WE HAVE ONE QUESTION. >> MENTAL HEALTH IS BLACK BOX. THE MOST DEVELOPED COUNTRIES WITH THE ACCESS TO MRI AND ALL THE OTHER THINGS. SO HOW DO YOU DEAL WITH SOME OF THE ISSUES OF THE MENTAL HEALTH OR TEASE THEM TO SCHIZOPHRENIA IN THE DEVELOPING COUNTRIES, OR VERY POOR COUNTRIES WITH LIMITED DISORDERS? ONCE YOU IDENTIFY SOMEBODY HAS THE PROBLEM HOW DO YOU CATEGORIZE? WHAT ARE THE WAYS YOU HANDLE IT WITHOUT ANY OF THESE RESOURCES OR LIMITED RESOURCES. >> THAT'S A GREAT WAY. THOSE ARE SOME QUESTIONS WE'RE TRYING TO ANSWER. MANY OF THESE COUNTRIES WILL HAVE -- LIBERIA AS AN EXTREME, LIBERIA HAS ONE PSYCHIATRIST, IT HAS A NUMBER OF PSYCHIATRIC NURSES NOW WHO REALLY HAVE BEEN TRAINED OVER THE LAST SIX YEARS. BUT THOSE ARE THE RESOURCES THEY HAVE. THIS WORKFORCE IS BEING TRAINED TO RECOGNIZE SYMPTOMS, TO LEARN TO MAKE A DIAGNOSIS, AND TO DELIVER INTERVENTIONS TO THE PATIENTS THAT THEY SEE WHO COME INTO CLINICS OR WHO ARE ADMITTED TO THE HOSPITALS. I WOULD SAY THAT COUNTRIES MAY NOT HAVE A LOT BUT THEY USUALLY HAVE SOMETHING TO OFFER. AND SO THE KINDS OF -- AM I GETTING AT YOUR QUESTION? I THINK -- >> YES. DOWELS HAVE TO DEAL WITH SHAMAN IN THE EARLY STAGES IN AFRICA. >> DID YOU SAY -- >> SHAMANS. >> OH, SHAMANS. >> YES, YES. >> THE EXAMPLE OF ONE STUDY I WAS MENTIONING, CERTAINLY OFTEN THE MEDICAL, YOU KNOW, GOING TO A CLINIC, GOING TO A HOSPITAL MAY BE THE LAST PLACE IN THE PATHWAY TO CARE BECAUSE PEOPLE WILL OFTEN GO TO OTHER SOURCES FIRSTMENT PEOPLE MAY GO THEIR CHURCH, A TRADITIONAL AREA, IF YOU'RE IN A RURAL AREA OR THIS EXAMPLE I GAVE IN N GHANA WHERE THERE ARE NOT THAT MANY OPTIONS IN THE HEALTH SYSTEM. YES, PEOPLE WILL SEEK OTHER CARE FIRST AND THEY MAY OR MAY NOT MAKE IT TO MENTAL HEALTH SERVICES. IT DEPENDS ON THE STATE OF THE SERVICES IN THOSE COUNTRIES. >> GOOD LUCK. >> THANK YOU. >> OKAY. SO I KNOW YOU'RE WORRIED ABOUT THE DEEP HUMMING NOISE THAT'S COMING OUT. IT'S AN AIR HANDLING NOISE, WE DON'T HAVE ANY IMMEDIATE WAY TO DEAL WITH IT. SO IF IT COMES BACK OR IT'S BOTHERSOME JUST TRY TO TALK OVER IT AND IGNORE IT. WHICH IS PROBABLY TRUE OF A LOT OF ISSUES THAT COME UP IN THE INTRAMURAL PROGRAM. OKAY. OUR THIRD SPEAKER IS DAVID LIPPMAN, AS YOU KNOW THE SCIENTIFIC DIRECTOR OF THE NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION, THE NATIONAL LIBRARY OF MEDICINE. DAVID IS THE SORT OF INSPIRED LEADER OF COLLECTION OF IMPORTANT DATA THAT HE HAS MADE AVAILABLE TO MANY OF US, THE WORLD'S BIOMEDICAL LITERATURE, INFORMATION ABOUT THE GENOME, PROTEIN DATA AND SO ON AND SO FORTH. AND IT'S ALWAYS FUN TO TALK TO DAVID BECAUSE HE'S ALWAYS COMING UP WITH NEW CREATIVE WAYS IN WHICH BIOINFORMATICS AND COMPUTATIONAL INFORMATION CAN BE USED TO IMPROVE THE PUBLIC HEALTH. HE HAS A MEDICAL DEGREE FROM STATE UNIVERSITY OF NEW YORK AT BUFFALO, HE'S A MEMBER OF BOTH THE NATIONAL ACADEMY OF MEDICINE AND SCIENCE AND TODAY WILL TALK ABOUT A NATIONAL GENOMICS NETWORK FOR FOOD SAFETY. DAVID? >> THANK YOU, MICHAEL. THIS DOESN'T LOOK LIKE FOOD SAFETY ACTUALLY. THIS IS USEFUL TO THINK ABOUT THE NETWORK FOR FOOD SAFETY THAT I'M GOING TO TALK ABOUT IN THE CONTEXT OF A LARGER VISION FOR WHAT WE COULD DO WITH MONITORING SURVEILLANCE OF PATHOGENS, AND THAT MODEL I THINK IS REALLY THE WEATHER SERVICE WHICH IS AN INCREDIBLE SUCCESS. THE ACCURACY OF PREDICTIONS GETS BETTER ALL THE TIME. AND IT'S A COMPLEX SYSTEM WHERE FOR EXAMPLE THE U.S. IS COLLECTING DATA FROM SATELLITES, FROM LAND CENTERS, THE WATER, WE INTEGRATE ALL THAT INFORMATION. WE'RE MAKING PREDICTIONS OUT OF THAT DATA SO IT'S MUCH MORE PRO-ACTIVE THAN JUST RESPONSE AFTER A STORM. AND THE DATA IS OPENLY AVAILABLE TO COMPANIES, WE EXCHANGE DATA REGULARLY WITH EUROPEANS, TO IMPROVE THE PREDICTIONS. AND SO THE QUESTION IS COULD WE WORK TOWARDS A GLOBAL NETWORK LIKE THIS FOR PATHOGEN SURVEILLANCE, AND WHAT WOULD IT INVOLVE? MUCH MORE COMPREHENSIVE SAMPLING SO WE COULD DO MODELING, WE DO COLLECTION INTERNATIONALLY, FOR EXAMPLE, FOR FLU, BUT THE NUMBERS ARE TOO LOW TO REALLY DO GOOD STATISTICAL MODELING. WE SHOULD INCLUDE ENVIRONMENTAL SAMPLING AS WELL. I THINK THE IDEA OF DOING FULL GENOME SEQUENCING FOR BACTERIAL AND VIRAL AND BACTERIAL PATHOGENS IS POSSIBLE IN THE NEAR FUTURE. THE PRINCIPLE OF HAVING THE DATA BE OPEN IS CRITICAL AND I'LL TOUCH ON THAT IN A MINUTE. AND WE ALREADY HAVE A MULTIPLE COMPREHENSIVE REPOSITORY FOR DNA SEQUENCE DATA SO THE IDEA WOULD BE RATHER THAN JUST STARTING TO COLLECT ISOLATES AT THE TIME OF AN OUTBREAK LIKE WHAT'S HAPPENED WITH EBOLA AND MANY OTHER OUTBREAKS, BUT TO HAVE ONGOING COLLECTION HOPEFULLY PREDICTION. BUT THAT'S KIND OF A VISION FOR THE FUTURE. I CAN TALK ABOUT SOMETHING THAT'S SORT OF REALLY ALREADY WORKING. AND THAT'S WITH RESPECT TO FOOD-BORNE ILLNESS. IT'S MORE COMMON THAN YOU MIGHT THINK. FORTUNATELY THE NUMBER OF DEATHS IS RELATIVELY LOW BUT THE COST IS QUITE SUBSTANTIAL. AND BECAUSE OF THIS, WE HAVE AN EXISTING SYSTEM IN THE U.S. FOR FOOD SAFETY, AND IT'S ACTUALLY WORLD CLASS. I THINK IT'S AS GOOD AS ANY SYSTEM IN THE WORLD. BUT THE CHALLENGE THEY HAVE IS AS EARLY AS POSSIBLE TO DETECT AN OUTBREAK AND FIND THE SOURCE. AND ESSENTIALLY, AN OUTBREAK IS WHERE YOU HAVE TWO OR MORE CASES WHICH COME FROM THE SAME SOURCE, AND CURRENTLY THEY USE A VARIETY OF EPIDEMIOLOGICAL INFORMATION AND COARSE GRAIN GENOTYPING, WITH FULL GENOME SEQUENCING WE SHOULD BE BE ABLE TO DO THAT MUCH BETTER. I GUESS THE SCOPE OF THE CHALLENGE IS QUITE BROAD WHEN YOU LOOK AT ALL THE WAYS FOOD IS PRODUCED IN THIS COUNTRY AND ELSEWHERE AND IT COMES TO THIS COUNTRY, NO LONGER LOCAL, ALTHOUGH IT'S SOMETHING WE LIKE TO HAVE AT SOME RESTAURANTS, TYPICALLY IF YOU HAVE A MEAL YOU'RE GETTING FOOD FROM QUITE THE DISTANT PLACES. AND ALTHOUGH THE SYSTEM THE U.S. IS QUITE GOOD, IT'S BEEN DIFFICULT OVER THE LAST FEW YEARS TO ACTUALLY REDUCE THE NUMBER OF CASES AND COST AND LOSS OF LIFE. SO THE HOPE WITH DNA SEQUENCING FOR THIS IS RELATED TO NOT WHAT WE'RE TRYING TO DO WITH PRECISION MEDICINE, MEDICAL GENETICS, WHERE REALLY THE GOAL IS TO GO FROM GENOTYPE TO PHENOTYPE BUT IT'S MORE LIKE DNA FORENSICS, AND THAT'S WHY IT'S A NO BRAINER. IN DNA FORENSICS, THERE'S BLOOD IN THE SCENE OF A CRIME. THEY GET THE DNA PROFILE. AND THEN YOU CAN TAKE A SUSPECT, GET THE DNA PROFILE FOR THEM AND PUT THEM CLEARLY AT THE SCENE OF THE CRIME, VERY HIGH PROBABILITY. FURTHERMORE, THERE'S SOMETHING CALLED THE COLD HIT, BECAUSE WE HAVE DNA PROFILE DATABASES LIKE CODUS, FELONS GET PROFILED, IT GOES IN THE DATABASE AND YOU CAN OFTEN TAKE THE DNA PROFILE, FINGERPRINT FROM THE SCENE OF A CRIME, SEARCH AGAINST THE CODUS DATABASE AND GET THIS COLD HIT. AS THE DATABASE BECOMES MORE COMPREHENSIVE IT'S A WAY OF GETTING SOMEBODY WHO MIGHT HAVE COMMITTED A MORE MINOR OFFENSE, CORRECT THEM TO A MORE SERIOUS ONE. AND I'LL DESCRIBE HOW THAT ALSO APPLIES TO THE FOOD SAFETY PROBLEM. THE OTHER ATTRACTIVE ASPECT OF DNA EXPENSE, WHOLE GENOME SEQUENCE, AS DIAGNOSTIC ASSAY IN FOOD SAFETY IS IT CAN BE USED ACROSS THE BOARD. SPECIFIC ASSAYS HAVE TO BE TAILORED TO EACH PATHOGEN, BECAUSE THE BACTERIA AND VIRUSES ARE ALWAYS EVOLVING YOU HAVE TO KEEP MODIFYING YOUR ASSAYS. THIS BRUTE FORCE APPROACH CAN BE USED ACROSS THE BOARD, BECAUSE SEQUENCING HAS GOTTEN SO CHEAP IT BECOMES FEASIBLE AND MEANS THE LABS THAT DO THIS ONCE YOU DEVELOPED THE PIPELINE, YOU CAN USE THE SAME EQUIPMENT OVER AND OVER AGAIN. FURTHERMORE DNA SEQUENCE INFORMATION IS SO INFORMATIVE AS COMPARED TO OTHER KINDS OF ASSAYS YOU DON'T NEED EPIDEMIOLOGICAL PIECE S OF DATA TO MAKE THIS AVAILABLE. THE PARTICIPANTS IN THIS AND THE COLLABORATION, FDA, CDC, PUBLIC HEALTH LAST ACROSS THE COUNTRY AND USDA, THEY ARE MORE COMFORTABLE SHARING A CERTAIN AMOUNT OF DATA THAN ABSOLUTELY ALL THE DATA, YET IT CAN BE USEFUL AS IS. SO I WANT TO TALK ABOUT THE ISSUE OF OPEN DATA. EARLY ON IN THIS PROJECT, ONE OF THE PRIME MOVERS, STEVE MUSSER FROM FDA PUSHED HARD THAT FROM THE BEGINNING OF THIS COLLABORATION WE SHOULD REALLY TRY TO MAKE THE DATA FULLY OPEN, SO AS YOU'LL SEE ALL OF THE PARTICIPANTS IN THIS, WHEN THE ISOLATES ARE SEQUENCED, RAW DATA BECOMES AVAILABLE AT NCBI, AND THIS IS REALLY AN IMPORTANT ASPECT OF THIS, WHICH IS SIMILAR TO WEATHER SERVICE, UNFORTUNATELY THE RESPONSE TO PUBLIC HEALTH EMERGENCIES LIKE EBOLA, EARLIER BIRD FLU, THERE'S BEEN A NUMBER OF ISSUES WITH DATA SHARING WHERE GROUPS WOULD GET THE DATA AND THEN NOT MAKE IT AVAILABLE IN THE CASE OF BIRD FLU DISPUTES ABOUT PUBLICATION, ABOUT I.P. ACTUALLY LED INDONESIA TO PULL OUT OF THE INTERNATIONAL CONSORTIUM FOR FLU, THE NETWORK FOR FLU, THEY HAVE COME BACK IN BUT THERE HAVE BEEN CONTINUED PROBLEMS WITH OTHER AVIAN FLU, EVEN SEASONAL FLU SHARING HAS BEEN DIFFICULT, AND WITH EBOLA IT WAS SIGNIFICANT ENOUGH PROBLEM THAT THEY EARLIER THIS MONTH HAD A MEETING, THE WORLD HEALTH ORGANIZATION, TO SEE IF THEY COULD CHANGE THIS. I THINK THAT AN IMPORTANT THING WITH THE FOOD SAFETY PROJECT WAS RIGHT AT THE VERY BEGINNING THERE WAS A COMMITMENT TO KEEP THE DATA OPEN, AND THAT'S -- THE CAUSAL COLLECTING DATA ONGOING, IT'S NOT SPORADIC, YOU'RE NOT TESTED. THE DATA IS ALWAYS FLOWING OUT. OKAY. SO THE SYSTEM THAT'S BEEN IN PLACE IN THE U.S., PULSE NET, HAS BEEN QUITE EFFECTIVE. WHAT HAPPENS IS LET'S SAY THERE'S A REPORTABLE PATHOGEN, SAY SALMONELLA, SOMEBODY IN AN EMERGENCY ROOM IN CLEVELAND HAS THAT, THAT EMERGENCY ROOM WOULD PROVIDE SOME METADATA AND ISOLATE TO THE PUBLIC HEALTH LAB IN OHIO, THEY WOULD CHARACTERIZE IT IN A FEW WAYS, INCLUDING COARSE GRAIN GENOTYPING, GOING INTO THE PULSE NET NETWORK AND BE EVALUATED, LIKE THE WEATHER SERVICE IN THE SENSE THE CDC AND FDA AND STATE LABS ARE MONITORING POTENTIAL OUTBREAKS ALL THE TIME. DATA COLLECTION COMES IN ALL THE TIME. THE ADVANTAGE OF WHOLE GENOME SEQUENCING, THEY COULD DETECT OUTBREAKS EARLIER. FDA HAD THE VISION, STEVE MUSSER DID, FOR GENOME TRACKING PROVIDING SEQUENCE EQUIPMENT, REAGENTS TO PUBLIC HEALTH LABS AND REGIONAL FDA LABS AROUND THE COUNTRY AND ACTUALLY ARGENTINA AND IN THE U.K., AND THOSE GROUPS HAVE ALL COMMITTED TO SHARING THE DATA, METADATA AND SO FORTH. SO THE FIRST PROJECT, THE FIRST PATHOGEN WHICH HAS BEEN TAKEN ON IN A COMPREHENSIVE WAY IS LISTERIA. THAT WAS CDC'S IDEA BECAUSE THE NUMBER OF CASES IS NOT THAT HIGH COMPARED TO THE OTHER FOOD PATHOGENS, BUT THE MORBIDITY AND MORTALITY IS QUITE SIGNIFICANT. AND THE COST IS AS WELL. AND SO A LITTLE OVER A YEAR-AND-A-HALF AGO, THE PILOT STARTED WITH FDA, CDC AND CBI AND STATE LABS TO TAKE EVERY CASE THAT CAME IN IN THE CURRENT SYSTEM THAT WAS CAUGHT IN THE CURRENT SYSTEM OF LISTERIA AND ADD WHOLE GENOME SYSTEM, HAVE THE DATA FLOW TO NCBI, SEND THE TO THE LABS AND FDA AND CDC. THE BOTTOM IS THE WORK IN THE LABS PRIOR TO GENOME SEQUENCING. PATHOGEN, ISOLATE COMES FROM EMERGENCY ROOM HOSPITAL TO THE STATE LAB, LET'S SAY, ISOLATE IN ROCHESTER, NEW YORK, WOULD GO TO WADSWORTH LAB IN ALBANY. THEY CHARACTERIZE USING SEROLOGY, COARSE GRAIN GENOTYPING, IT TAKES A COUPLE WEEKS. PIGGYBACKING ON THE PROCESS, WHAT THESE LABS ARE DOING, AS SOON AS THEY CAN GET THE ISOLATES READY FOR SEQUENCING, THEY SEQUENCE, SEND THE RAW DATA TO NCBI, IN A FEW HOURS WE'VE DONE THE ANALYSIS AND SEND IT BACK TO ALL THE GROUPS, AND IN FACT THIS LITTLE TIME TEST WE DID WITH WADSWORTH LAB WAS DONE VERY EARLY IN THE PROJECT, AND NOW THEY HAVE CUT THIS DOWN BY SEVERAL DAYS, AND THE GOAL IS TO MAKE IT EVEN FASTER OVER THIS NEXT YEAR. AN IMPORTANT ASPECT OF THE PROJECT, ONE OF THE COMPLEXITIES, IS THAT THIS IS SORT OF A BIG DATA PROJECT, AND THIS IS SORT OF FAIRLY HIGH THROUGHPUT GENOMICS. I'LL SHOW YOU NUMBERS IN A MOMENT. BUT THE LABS ARE NOT USED TO DOING THIS, NOT LIKE, SAY, THE BROAD LAB OR WASHINGTON UNIVERSITY GENOMICS LAB. SO GETTING THESE CENTERS TO BE ABLE TO GET THE WHOLE PROCESS WORKING IS TAKING A LITTLE BIT OF TIME, CURRENTLY MOST OF THE ISOLATES ARE SUBMITTED TO US BY BEING BROKERED BY FDA OR CDC. THE STATE LAB WILL SOMEHOW GET THE DATA, METADATA AND RAW CONSEQUENCE AND SEND IT TO US. WHAT WE'VE BEEN SHIFTING TO, OVER THE NEXT YEAR WE'LL BE DOING MUCH MORE INTENSIVELY, IS HAVING ALL OF THE DISPARATE SITES SENDING DATA TO US, WE HAVE TO WORK WITH THEM TO DO THIS IN A RELIABLE AND EFFICIENT WAY. BUT THESE GROUPS, A NUMBER HAVE BEEN DOING THIS. YOU CAN SEE A NUMBER ARE IN THE U.K. AND WE ALSO HAVE A PILOT AT BRIGHAM AND WOMEN'S HOSPITAL, THAT'S FOCUSED AS WELL ON AMR AND NOT JUST FOOD SAFETY. SO THE PUNCHLINE HERE IS THAT THIS HAS BEEN SUCCESSFUL FAR BEYOND THE EXPECTATIONS OF THE PARTICIPANTS. ALMOST IMMEDIATELY, WHEN THE PROJECT WAS STARTED, AN OUTBREAK WAS DETECTED IN THE CASE OF FRESCO, THERE WERE A FEW CASES THAT WERE ON THE EAST COAST, AND A HANDFUL IN CALIFORNIA, ONE OF WHICH LED TO A DEATH. BUT THE ISOLATES WERE SEQUENCED, AND WERE FOUND TO BE ONLY A FEW MUTATIONAL DIFFERENCES APART, SO A GENOME IS ABOUT 4 MILLION BASES OR SO, AND THERE WERE ONLY A HANDFUL OF MUTATIONAL DIFFERENCES WHICH REALLY MADE THEM HIGHLY SUSPICIOUS. AMAZINGLY, HOWEVER, THE FDA IN ONE OF ITS ROUTINE INSPECTIONS HAD GONE TO A PRODUCTION FACILITY IN DELAWARE, DID A SWAB OF THE EQUIPMENT THAT WAS ALREADY IN THE FREEZER, HAD BEEN SEQUENCED, AND THE MATCH WAS FOUND IMMEDIATELY. ALMOST, YOU KNOW, JUST WITH A FEW CASES THEY WERE ABLE TO HAVE ENOUGH DATA TO SHUT DOWN THE PLANT, DO A RECALL AND REDUCE THE NUMBER OF PEOPLE AFFECTED. THIS REALLY BUILT A HUGE AMOUNT OF MOMENTUM FOR THE PROJECT AND SINCE THEN THERE HAVE BEEN A NUMBER OF OTHER OUTBREAKS THAT WERE FOUND ON A VERY EARLY STAGE, ONE OF THEM HAD HIT THE NEWS, YOU MIGHT READ ABOUT THE BLUE BELL ICE CREAM OUTBREAK, QUITE EXTENSIVE INVOLVING MULTIPLE PRODUCTION FACILITIES AND THEY HAD TO SHUT DOWN ALL THEIR PRODUCTION. BUT THE INTERESTING THING ABOUT THAT CASE IS THAT WITH THE TRADITIONAL APPROACH WITH FOOD SAFETY, THE EPIDEMIOLOGICAL DATA IS WEAK ENOUGH, IF YOU WILL, THAT THEY HAVE TO KEEP THE TIME WINDOW FAIRLY NARROW. OTHERWISE YOU GET TOO MANY FALSE POSITIVES. YOU END UP HAVING TOO MANY SUSPECTS, SO YOU HAVE TOO MANY RED HERRINGS IF YOU DO AN INVESTIGATION. BUT BECAUSE THE SEQUENCE DATA IS SO SPECIFIC THAT DNA FINGERPRINT IS SO INFORMATIVE, THEY WERE ABLE TO TRACE BACK THESE OUTBREAKS, BACK I THINK ON THE ORDER OF TEN YEARS. AND REALLY PUT TOGETHER A WHOLE NETWORK OF CASES THAT HAD OCCURRED AROUND THE COUNTRY. BECAUSE OF THE LEGAL NATURE OF THE COMPLIANCE ACTIONS FDA TAKES WE DON'T KNOW THE SPECIFICS OF THE BULK OF THE CASES THAT HAVE BEEN BROKEN USING THIS SYSTEM. HOWEVER I'M ASSURED THERE WERE QUITE A FEW, AND IN FACT FROM WHAT THE LAST DATA THAT I SAW, WE'RE ON THE ORDER THIS YEAR OF DETECTING EIGHT TIMES THE NUMBER OF OUTBREAKS FROM PREVIOUS YEARS AND CATCHING THEM MUCH EARLIER SO THE NUMBER OF PEOPLE AFFECTED IS MUCH SMALLER. IT HAS BEEN EXPANDED TO LOOKING AT SALMONELLA AND COLI BUT NOT COMPREHENSIVELY BUT THERE HAVE BEEN OUTBREAKS WITH SALMONELLA, THIS AND OTHERS DETECTED WITH THE PILOT SO FAR. SO BUILDING ON FROM WHERE WE ARE RIGHT NOW, THE GOAL IS TO EXPAND BEYOND LISTERIA TO SALMONELLA, COLI, CAMPYLOBACTER, WE NEED TO MAKE THE WORKFLOW FOR PARTNERS SIMPLER, GET THE VARIOUS SITES GETTING THE ISOLATES AND CHARACTERIZING THEM, GETTING THEM TO BE ABLE TO SUBMIT DIRECTLY, AND WE WANT TO BE ABLE TO TURN THINGS AROUND FASTER AND SO WE'RE EXCITED ABOUT WHERE THAT'S GOING. I WANT TO GET A LITTLE BIT INTO WHAT'S INVOLVED THOUGH AT OUR END. SO THE KINDS OF ANALYSES THAT WE'RE TALKING ABOUT COULD PICK UP A LOT OF DIFFERENT JOURNAL, ANY MICROBIOLOGY JOURNAL, YOU'LL SEE FIGURES LIKE THIS WHERE RETROSPECTIVE ANALYSIS OF AN OUTBREAK IS DONE AND THESE TREES ARE BASED ON SINGLE NUCLEOTIDE POLYMORPHISMS WHERE EACH DIFFERENCE IS THOUGHT OF AS AN INDEPENDENT EVENT AND THEN THE OUTBREAKS TEND TO CLUSTER TOGETHER LIKE THIS. SO THAT'S WHAT WE'RE DOING IN THIS PROJECT AS WELL, BUT FOR FOOD SAFETY. BUT THE ISSUE WITH THESE PROJECTS WHICH ARE RETROSPECTIVE PROJECTS AND AREN'T DEALING WITH ONGOING HIGH NUMBER OF ISOLATES IS THAT THERE ARE STEPS NOT FULLY AUTOMATED, WHEN LOOKING AT COMPARISONS FOR EXAMPLE, WHEN LOOKING AT AT SIMPLIES OF THE GENOME THEY CAN LOOK FOR AREAS WHERE THERE MAY HAVE BEEN RECOMBINASE OR ASSEMBLY MIGHT HAVE CAUSED SOME -- BECAUSE OF REPEATS OR SOME OTHER PROBLEM, A NUMBER OF ERRORS IN A SMALL REGION, AND THOSE WOULD NOT BE INDEPENDENT DIFFERENCES. THOSE NEED TO BE FILTERED OUT AND THOSE ARE DONE IN A SORT OF SEMI AUTOMATIC PROCESS IN MOST OF THESE PAPERS. IN THIS PROJECT, BECAUSE OF THE SCALE, SO THIS IS A DASHBOARD, ONE OF THE DASHBOARDS WE USE FOR FOLLOWING IT, ON A TYPICAL DAY WE CAN GET OVER 200 ISOLATES, AND AS THIS PROJECT SCALES UP WE'LL BE GETTING OVER A THOUSAND EIGHTS, MAYBE TWO THOUSAND, DEPENDING ON WHAT OTHER PROJECTS FOLD IN, A DAY. THE ONLY WAY THIS CAN BE DONE IS BY MORE FULLY AUTOMATING IT SO THAT'S WHERE A LOT OF R&D AND GOING IS ON OUR, WE'VE MADE PROGRESS BUT I EXPECT OVER THE NEXT YEAR WE'LL HAVE A FULLY AUTOMATED PROCESSING PLACE THEY CAN SCALE UP FOR THE NUMBERS. ANOTHER ISSUE WHERE YOU NEED TO DO SORT OF AUTOMATED FILTERING AND SO FORTH IS YOU NEED TO DEAL WITH DIFFERENCES BETWEEN THE METHODOLOGY. WE WOULD LIKE ALL THE PROTOCOLS TO BE EXACTLY THE SAME, AND FOR THE PATHOGEN PROJECT PER SE THE COLLABORATORS ARE WORKING TOWARDS A SINGLE PROTOCOL. BUT THERE ARE ISOLATES THAT CAME FROM OTHER SOURCES AND WE NEED TO TAKE ADVANTAGE OF THOSE AS WELL, AND A LITTLE EXPERIMENT WAS DONE A WHILE BACK WITH OUR FDA COLLABORATORS, WHERE THEY SEQUENCED ABOUT A DOZEN DIFFERENT ISOLATES THAT WERE CLOSE, SEQUENCED WITH SEVERAL METHODS. AND AFTER OUR FILTERING WE WERE ABLE TO GET THE ISOLATES TO CONGREGATE BY SAMPLE AS YOU WOULD LIKE IT TO HAPPEN, NOT BY PLATFORM. IF YOU DIDN'T FILTER YOU GOT THE FOUR FIVE FOUR TO CLUSTER TOGETHER, SO THE SYSTEMATIC ERRORS THAT THE VARIOUS METHODS MAKE NEEDED TO BE FILTERED OUT AS PART OF THE PROCESS, THE ERROR CHARACTERISTICS. WELL, I WAS WONDERING HOW TO GET THIS DONE QUICKLY. I'M DOING GOOD. OKAY. SO THE AMR PROBLEM HAS GOTTEN A LOT OF ATTENTION THIS LAST YEAR. THERE WAS AN EXECUTIVE WHITE HOUSE REPORT ON THIS, WITH THE GOAL TO FAIRLYAMBITIOUS INITIATIVE TO TO COMBAT MICROBIAL RESISTANCE, THE INFRASTRUCTURE IS USEFUL ALTHOUGH WE HAVE TO ADD OTHER THINGS. THE SCALE OF THE PROBLEM IS LARGER, IN TERMS OF THE NUMBER OF AFFECTED INDIVIDUALS, THE NUMBERS ARE NOT AS BAD, THE NUMBER OF DEATHS IS GREATER, THE NUMBER OF DIFFERENT SITES THAT WOULD WANT TO BE ABLE TO GET INFORMATION IN TERMS OF A POSSIBLE OUTBREAK WITHIN THE INSTITUTION IS MUCH GREATER SO THE CHALLENGE HERE IS GREATER FOR SEVERAL REASONS AND I'LL GET INTO THAT IN A SECOND. SO WE'VE BEEN WORKING WITH NIAID, WITH FDA, CDC, AND INDIVIDUAL HOSPITALS STARTING WITH BRIGHAM AND WOMEN'S ON THIS, AND DoD I SHOULD SAY. WHAT WE ALREADY HAVE IN PLACE IS A SYSTEM THAT CAN TAKE SEQUENCED ISOLATES WITH ANTI-BIOGRAM INFORMATION, ILLRELEVANT MET A DATA, THERE'S A GOAL TO HAVE A REFERENCE DATABASE FOR WELL CHARACTERIZED BACTERIA WITH THE SEQUENCE SO THAT ONE CAN COME UP WITH BETTER DIAGNOSTICS. AND RECOGNIZE RECOGNIZING NEW. WE'VE BEEN STANDARDIZING NOMENCLATURE, WORKING TO KEEP THAT UP TO DATE, THAT'S A COLLABORATION WITH A VARIETY OF GROUPS. WE'RE ALSO WORKING ON DEVELOPING TOOLS FOR AMR GENES, THE GOAL HERE IS TO PROVIDE A NUMBER OF TOOLS, NOT JUST LIKE IN THE FOOD SAFETY, THAT ARE RELEVANT FOR CDC FOR ITS NATIONWIDE SURVEILLANCE AND ALSO FOR HOSPITALS THAT WANT TO DETECT EARLY ON A POSSIBLE OUTBREAK WITHIN THE HOSPITAL, THAT'S WHY WE'RE WORKING NOW WITH BRIGHAM AND WOMEN'S HOSPITAL. SO THIS PROJECT, THERE'S REALLY QUITE A FEW PEOPLE WHO HAVE BEEN INVOLVED, THIS IS NOT ALL THE NAMES BUT FROM NCBI WE'VE HAD A LARGE TEAM WORKING ON THIS. IT'S BEEN A VERY EXCITING PROJECT AND ALL THE SENIOR FOLKS MEET ONCE A WEEK, AND GO OVER THE DATA, AND TRY TO FIGURE OUT WHAT'S HAPPENING IN THE WORK FLOW BECAUSE WE'RE GETTING ISOLATES ALL THE TIME. WE HAVE TO TURN THINGS AROUND QUICKLY, WE CAN'T BE THE RATE LIMITING STEP IN FOLLOWING WHAT'S GOING ON. THE FDA GROUP HAS BEEN GREAT TO WORK WITH. MARK ALLARD AND ERIC BROWN ARE ACTIVE NOT ONLY WITH THEIR OWN PROJECTS BUT WORKING WITH THE COLLABORATORS IN THE STATES AND OTHER COUNTRIES TO GET THEM INVOLVED. THE CDC GROUP HAS ALSO BEEN GREAT TO WORK WITH. THEY ARE THE MAIN FORCE RESPONSIBLE FOR PULSE NET AND INTEGRATING PULSE NET ACTIVITY, THE CURRENT STATE OF THE ART INTO THIS NEW THING HAS BEEN -- THEY HAVE BEEN ACTIVELY INVOLVED IN THAT. FINALLY THE STATE LABS HAVE BEEN EXCELLENT TO WORK WITH. AND THERE ARE MORE COMING ON BOARD. WADSWORTH LAB IN NEW YORK STATE HAS BEEN ONE OF THE STRONGEST CENTERS PUSHING FORWARD AND THEY ARE DIRECTLY SUBMITTING TO US. THE U.S.DA IS COLLABORATING WITH US, IT WOULD BE D BE IMPORTANT TO GET THE ISOLATES FROM FARMS, AND MARIA HAS BEEN TERRIFIC AND WE'RE WORKING WITH HER NOT JUST FOOD SAFETY BUT WITH THE CENTERS THEY FUND, BROAD AND JCBI. SO THANK YOU. [APPLAUSE] >> DAVID, THANK YOU. SINCE WE'RE PLANNING TO HAVE A PANEL DISCUSSION, WHY DON'T WE HOLD OFF QUESTIONS UNTIL THAT PERIOD. LET ME BRING ALL THE SPEAKERS AND OUR TWO ADDITIONAL PANELISTS, DR. LINDA BIRNBAUM, DIRECTOR OF NIEHS, AND TONY FAUCI, DIRECTOR OF NIAID, UP HERE, BEFORE WE BEGIN THE DISCUSSION DR. BIRNBAUM IS GOING TO SAY A FEW WORDS ABOUT THE IMPORTANT ROLE NIEHS PLAYS IN PUBLIC HEALTH AT THE NIH. >> GOOD MORNING, EVERYBODY. WE'RE THE INSTITUTE THAT PEOPLE LOVE TO FORGET JUST BECAUSE WE'RE NOT DISEASE ORIENTED AND WE'RE ALSO NOT HERE, AS YOU KNOW WE'RE IN THE SOUTHERN PART OF HEAVEN. WHAT I WANTED TO DO IF I CAN GET THE SLIDES UP HERE VERY BRIEFLY, I HOPE THE SLIDES ARE COMING UP. I WANTED TO TALK TO YOU ABOUT THE DISASTER RESEARCH RESPONSE EFFORT THAT NIEHS IS LEADING. ALSO A LITTLE BIT ABOUT HOW THIS FITS INTO THE WHOLE GLOBAL HEALTH AREA, ESPECIALLY WITH CLIMATE CHANGE. SO -- OOPS. LET ME SEE IF I CAN GET OUT OF THAT. OKAY. SO IT LOOKS LIKE I'M MISSING THE SLIDES I WANTED TO HAVE IN HERE RELATED TO DISASTER RESEARCH RESPONSE BUT I THINK MANY OF YOU MAY REMEMBER THAT ABOUT 2 1/2 YEARS AGO FRANCIS COLLINS, ALONG WITH NIKKI LAURIE AND TOM FRIEDMAN PUT AN ARTICLE IN NEW ENGLAND JOURNAL OF MEDICINE FOCUSING ON THE NEED TO CONDUCT RESEARCH IN A DISASTER SITUATION. AND THE REASON OBVIOUSLY YOU DON'T WANT TO INTERFERE WITH EMERGENCY RESPONSE BUT YOU NEED TO BE ABLE TO DO SOME RESEARCH SO YOU CAN HAVE BETTER RESPONSE THE NEXT TIME AS WELL AS WHAT YOU DO WITH ANY OF THE HEALTH POLLUTION -- THE ENVIRONMENTAL IMPACTS OF A DISASTER, WHETHER IT'S SOMETHING LIKE AN INFECTIOUS AGENT OR ENVIRONMENTAL DISASTER OR INDUSTRIAL DISASTER. AND NIEHS HAS BEEN VERY INVOLVED WITH RESPONSE TO 9/11, KATRINA, GULF OIL SPILL, MORE RECENTLY HURRICANE SANDY AND ITS IMPACT, EVEN MORE RECENTLY SOME OF THE THINGS FOR EXAMPLE IN WEST VIRGINIA WITH THE POLLUTION OF THE ELK RIVER. AND SO WHAT WE'VE COME UP WITH IS THERE'S ACROSS INSTITUTE EFFORTS, IT SAYS WORK GROUP THAT MEETS ONCE A MONTH, THE NIH DISASTER RESEARCH INTEREST GROUP THAT MEETS ONCE A MONTH BY PHONE CALLS AND WE'VE BEEN PARTNERING CLOSELY NOT ONLY WITH THE NATIONAL LIBRARY OF MEDICINE TO LEAD THIS EFFORT BUT ALSO WITH THE CDC AND WITH THE ASSISTANT SECOND FOR PREPAREDNESS AND RESPONSE, HER EFFORT, EPA AND OTHER FEDERAL AGENCIES WHO HAVE A ROLE PLAYING IN DISASTER RESPONSE. THERE'S A FACT SHEET ON THE TABLE THAT TALKS ABOUT PROJECT OBJECTIVES AND ACCOMPLISHMENTS SO FAR. I DID WANT TO MENTION THERE'S A ROBUST AND VERY ACTIVE WEBSITE AVAILABLE ON THE NLM WEBSITE, DISASTER RERESPONSE, DR-2, THAT HAS SOME THINGS DEVELOPED, FOR EXAMPLE FIT FOR PURPOSE AND READY TO GO PROTOCOLS THAT CAN BE USED, THEY HAVE BEEN APPROVED BY -- PRE-APPROVED BY THE NIEHS IRB FOR USE IN INTRAMURAL RESEARCH, WITH DIFFERENT KINDS OF PROTOCOLS THAT YOU COULD JUST PULL UP IN DIFFERENT KINDS OF OPPORTUNITIES. THERE'S A GREAT DEAL OF TRAINING MATERIAL AND GUIDANCE ON THAT WEBSITE. APHA IS GOING TO IT, CDC IS GOING TO IT WHENEVER THERE'S A DISASTER SCENARIO TO GET GOING QUICKLY. SO WE'RE ALWAYS INTERESTED IN NEW PARTNERS. SORRY THOSE TWO SLIDES APPEAR TO HAVE BEEN MISSING. WHAT WE'RE DEALING WITH GLOBAL RELATED HEALTH, THE ISSUE IS HOW WE'RE DEALING WITH THEM. IT'S A WORD SLIDE SHOWING HOW AIR POLLUTION AFFECTS ALMOST EVERY KIND OF ASPECT OF YOUR LIFE, RANGING FROM IQ DEFICITS AND BEHAVIORAL AND AUTISM AND DIABETES AND CLEARLY INFECTIOUS DISEASES, ALSO PULMONARY DISEASES, CANCER AND CARDIOVASCULAR DISEASES, BUT WE TALK ABOUT AIR POLLUTION AND ABOUT 7 MILLION PEOPLE DIE A YEAR AROUND THE WORLD FROM AIR POLLUTION. BUT ABOUT 3 BILLION OF THOSE, 3 TO 4 BILLION OF THOSE, ARE DYING FROM INDOOR AIR POLLUTION. WHY WE DON'T THINK ABOUT INDOOR AIR POLLUTION BEING AS BAD AS OUTDOOR AIR POLLUTION WHEN IT'S ORDERS OF MAGNITUDE WORSE, NIH HAS BEEN ABLE TO PARTNER RECENTLY WITH THE BILL AND MELINDA GATES FOUNDATION WORKING WITH NIEHS, FOGARTY CENTER, NHLBI AND NICHD IN A MULTI-YEAR INTERVENTIONAL TRIAL LOOKING AT SWITCHING OUT DIFFERENT STOVES IN LARGELY DEVELOPING COUNTRIES TO LOOK AT IMPACTS FROM INDOOR AIR POLLUTION. I DO WANT TO -- WELL, AGAIN SOME OF THE INDOOR AIR QUALITY ISSUES, WE'RE FINDING ASSOCIATIONS WITH DECREASE THE NEURODEVELOPMENTAL PERFORMANCE, I.Q. AND BEHAVIORAL. IMPACTS ON LOW BODY WEIGHT RESPIRATORY RATE AND INFANT MORTALITY, ASTHMA AND HOUSEHOLD COOKING, CARDIOVASCULAR AND RESPIRATORY DISEASE AND DECREASED LUNGS FUNCTION. I THINK SOME OF THE MAIN POINTS THAT WE HAVE TO DEAL WITH HERE IS THAT THERE'S STILL 13 MILLION PEOPLE IN THE UNITED STATES WHO ACTUALLY ARE HEATING WITH BIOMASS INDOORS AND ARE SUBJECT TO HIGH LEVEL OF INDOOR AIR POLLUTION. OTHER ISSUES SPREADING AROUND THE WORLD CREATING ENVIRONMENTAL HEALTH CONCERNS FOR EXAMPLE E-WASTE EVERY TIME YOU GET RID OF A CELL PHONE OR ELECTRONICS, DON'T THINK IT STAYS IN THIS COUNTRY. IN MANY CASE IT'S PUT ON SHIPS AND SENT TO THE LESS DEVELOPED WORLD. IN THESE SITUATIONS, PEOPLE ARE BEING VERY HEAVILY EXPOSED, OFTEN WOMEN AND CHILDREN, TO HIGH LEVELS OF HEAVY METALS, CHROMIUM, FLAME RETARDANTS, PCBs AND PAHs. WE'VE GOT AN INTRAMURAL PROGRAM LOOKING AT ISSUES, FOCUSING ON WOMEN, RECYCLERS, A GROUP THAT'S NEVER BEEN STUDIED AT ALL. I REALLY WANTED TO GET BRIEFLY TO THE ISSUE OF CLIMATE CHANGE AND EMERGENCY IMPACTS THERE. WE KNOW THERE ARE OVER 140,000 DEATHS, THAT'S 15 YEARS AGO, ASSOCIATED WITH IMPACT FROM CLIMATE CHANGE. THAT'S PROJECTED TO INCREASE, THE PROJECTIONS ARE GOING UP ABOVE THE 250,000 ANNUAL DEATHS. WE KNOW SOME THINGS THAT WE'RE SEEING CAUSING DEATHS ARE HEAT DISEASE, MALNUTRITION, DENGUE, ET CETERA, WITH HIGH LEVELS OF MORTALITY. WE'RE LOOKING AT POPULATION RISK, IT'S HARD TO IDENTIFY IN THE VISUAL BUT WE'RE FINDING THAT THERE'S CLEARLY CLIMATE IS CHANGING, WE'RE HAVING WARMER TEMPERATURES, MORE CONCENTRATED PRECIPITATION, MORE DROUGHTS AND SEVERE HURRICANES. THIS IS JUST A SLIDE SHOWING THE THINGS THAT ARE HAPPENING AS THE CLIMATE IS CHANGING, WE'RE HAVING INCREASED CO2 LEVELS, IN THE OCEAN. RISING TEMPERATURES. EXTREME WEATHER EVENTS AND RISING SEA LEVELS. THIS IS ASSOCIATED FOR EXAMPLE WITH MORE AIR POLLUTION, CHANGES IN VECTOR ECOLOGY, ASSOCIATED WITH INCREASES AT DIFFERENT LOCATIONS FROM MALARIA AND DENGUE AND ENCEPHALITIS AND SO ON. WE'RE HAVING INCREASING ALLERGIES, RESPIRATORY, ASTHMA, HAYFEVER SEASON CHANGES, ISSUES OF FOOD SECURITY AS FOOD IN CERTAIN AREAS YOU'RE GETTING A DISCONNECT BETWEEN WHERE THE PREDATORS AND PREY MAY BE, OR WHERE THE FOOD IS AVAILABLE, LEADING TO INCREASES, MALNUTRITION AND DIARRHEA, EXTREME HEAT IS DIFFICULT FOR ELDERLY AND YOUNG, ESPECIALLY IN LESS WELL COUNTRIES AND WE HAVE INCREASED DEATH AND CARDIOVASCULAR IMPACT, SEVERE WEATHER FOR EXAMPLE A LOT MORE INJURIES, FATALITIES. I WANT TO PUT THAT ON THE RADAR SCREENS AS ISSUES WE'RE GOING TO NEED TO BE DEALING WITH IN EMERGENCY RESPONSE FROM A HEALTH IMPACT PERSPECTIVE. THANKS. [APPLAUSE] >> THANK YOU, LINDA, FOR THAT PRESENTATION. WE'LL GENERATE SOME DISCUSSION RELATED TO THE PRESENTATIONS FROM THE THREE INDIVIDUALS, CLIFF, PAMELA, AND DAVID. IF THERE ARE ANY QUESTIONS FROM THE AUDIENCE PLEASE JUST GO UP TO A MICROPHONE. I'LL KEEP MY EYE OUT ON THE MICROPHONES AND BE HAPPY TO ENTERTAIN QUESTIONS. SO -- AH, THERE YOU GO, STARTING RIGHT OFF. YOU TOOK THE WORDS RIGHT OUT OF MY MOUTH. GO AHEAD. >> WELL, AS A CONSUMER, I GUESS WE'RE VERY MUCH INTERESTED FROM ALL OUTCOME OF SOME OF THE BASIC LEVEL INVESTIGATIONS, YOU'RE FINDING ESPECIALLY FROM DR. LIPPMAN'S STUDIES, THE EFFECT OF ANTI-MICROBIAL GENES. HOW DO YOU FILTER BASIC SCIENCE TO THE PUBLIC AS YOUR WEBSITE, COULD YOU MAKE IT AVAILABLE? FOR QUICK CONSUMPTION, QUICK CHECKING, IF SOMETHING GOES WRONG, SO THEY COULD GO AND CHECK IT OUT? HOW MUCH OF THIS DATA IS FILTERED OUT AND HOW LONG DOES IT TAKE FOR IT TO GO TO THE PUBLIC, WHO MIGHT BE SUFFERING FROM THE CONSEQUENCES OF THOSE BUGS IN FOODS AND OTHER AREAS? >> FOR THE FOOD SAFETY PROJECT, THE DATA IS RELEASED ALMOST IMMEDIATELY. BUT WE DON'T YET HAVE VIEWS OF THE DATA THAT ARE REALLY THAT USEFUL FOR SOMEBODY OUTSIDE THE PROJECT, AND THAT'S WHAT WE'RE WORKING ON, OVER THIS YEAR, THE TOOLS WE'RE PUTTING TOGETHER USED BY THE FOLKS AT THE STATE LABS AND FDA, AND EPIDEMIOLOGISTS, SOME OF THOSE CAN HAVE USED THAT, I DON'T KNOW IF A CONSUMER WILL FIND THEM USEFUL REALLY, BUT CERTAINLY FOLKS INTERESTED IN RESEARCH WILL FIND THEM INTERESTING. I SHOULD POINT OUT THAT THE AVAILABILITY OF SO MANY ISOLATES WHICH ARE CHARACTERIZED AT SOME LEVEL OR LET'S SAY FOR THE FOOD SAFETY PROJECT WHERE THEY ARE SO CLOSELY RELATED ALLOWED US AS PART OF OUR R&D FOR OUR REGULAR PROCESS TO MAKE NEW FINDINGS, FOR EXAMPLE IN SALMONELLA WE FOUND A GENE WE HAVE TO DO MORE WORK ON THAT'S UNDER STRONG POSITIVE SELECTION THAT WE WEREN'T AWARE OF IN THE PAST. THAT MAY BE OF INTEREST. BUT I THINK THE OVERALL PROJECT WITH AMR, THE DIRECTION THAT'S GOING WITH CDC COLLECTING MUCH MORE EPIDEMIOLOGICAL INFORMATION, DIVING IN MORE TO GET SEQUENCE INFORMATION, THE GOAL THERE IS TO COMPLEMENT THE OVERALL AMR INITIATIVE, WHICH WOULD BE TO, YOU KNOW, USE ANTIBIOTICS MUCH MORE WISELY AND RESEARCH THEM FOR WHERE THEY ARE MOST EFFECTIVE AND NEEDED, AND SO GOAL ON THAT PROJECT I THINK WOULD BE TO IN CONJUNCTION WITH OTHER KINDS OF INFORMATION PROVIDE MUCH BETTER GUIDELINES FOR PHYSICIANS IN THE USE OF ANTI-MICROBIAL AGENTS AND ALSO ULTIMATELY FOR THE PUBLIC TO BE EDUCATED AS TO WHAT ARE THOSE CONDITIONS WHERE ANTIBIOTICS AREN'T HELPFUL AND ACTUALLY EXACERBATE AN EXISTING PROBLEM. >> I WOULD LIKE TO SEE THE SUMMARY SLIDES. I LOVE YOUR SLIDES OF ALL THE INFECTION FROM ALL THE FOOD-BORNE BACTERIA. I DID NOT KNOW MY FAVORITE CILANTRO MAY HAVE BUGS I HAVE TO WORRY ABOUT WHEN I'M MAKING SALSA OR WHATEVER IT IS. THOSE SUMMARY SLIDES, COULD WE PUT ON THE WEBSITE AT THE ORGANIZATION WHO IS DOING THE STUDIES? THEY DON'T HAVE TO TELL ALL THE TECHNICAL DETAILS, THE SUMMARY OF FINDINGS THAT COULD BE AVAILABLE, SHOULD BE MABEL AVAILABLE QUICKLY TO THE CONSUMER PUBLIC. >> THANK YOU. YEAH. >> I JUST WANTED TO KIND OF -- A LITTLE BIT OF WHAT DR. COLLINS WAS SAYING, THE NEED FOR MENTAL HEALTH DEALING WITH THESE RESPONSES AND MAKE THE COMMENT WITH RESPONSE TO THE GULF OIL SPILL WHERE WE HAVE -- WITH DR. COLLINS DIRECTORS FUND, COMMON FUND AND OTHER RESOURCES WE'VE BEEN ABLE TO AVAILABLE, WE SPENT $60 MILLION ON RESPONSE TO GULF OIL SPILL AND MUCH OF THAT WORK HAS FOCUSED ON MENTAL HEALTH ISSUES WHERE WE'VE PARTNERED FOR EXAMPLE BOTH WITH NIMH AND SAMHSA TO GET THEM INVOLVED FROM THE BEGINNING BECAUSE THE CLEAR NEED TO WORK WITH WHATEVER KIND OF EMERGENCY RESPONSE IS RESILIENCY OF THE INDIVIDUAL AND THE COMMUNITY. >> I HAVE A COUPLE QUESTIONS THAT STRUCK ME AS THE PRESENTERS WERE PRESENTING. CLIFF, YOU MENTIONED THE ISSUE OF BUILDING SOME INFRASTRUCTURE AND REDEMPTION HOSPITAL IN JFK. YOU'VE BEEN THERE NOW MANY TIMES. AT LEAST 11, TO MY COUNT, OVER THE LAST FEW MONTHS. WHAT IS YOUR PERCEPTION OF THE ROLE OF THE INTRAMURAL PROGRAM IN TRYING TO HELP BUILD A SUSTAINABLE INFRASTRUCTURE LIKE YOU'VE BEEN DOING AT THOSE HOSPITALS, BECAUSE IT SEEMS THAT THE AMOUNT OF BENEFIT WE GET FROM THAT IS EXTRAORDINARY. YOU WANT TO AMPLIFY THAT A LITTLE BIT PLEASE? >> EACH OF THE HOSPITALS THAT WE'VE BEEN WORKING AT, AS WE'VE GONE IN, WE'VE UNFORTUNATELY FOUND VERY LITTLE IN THE WAY OF PRIMARY SUPPORT, EVEN JUST CLEAN CLINIC ROOMS WITH RUNNING WATER. SO WHAT WE'VE TRIED TO DO IS INVOLVE THE -- IN THE CASE OF LIBERIA, WHERE WE'VE DONE MOST OF THE WORK, IS INVOLVE THE LIBERIAN INFRASTRUCTURE IN A MAJOR WAY AS WE BUILD WHATEVER IT IS, WATER TOWER OR PUT IN A GENERATOR OR BUILD OUT A LAB, AND THEN HAVE OUR STAFF THAT ARE THERE REALLY THINK AS PAMELA WAS MENTIONING, AS AN ADVISORY ROLE WHILE THE LIBERIAN STAFF THEMSELVES LEARN THE TECHNIQUES THAT NEED TO BE PUT IN PLACE TO THEN USE THAT INFRASTRUCTURE. AND WE'VE BEEN -- IT'S REALLY BEEN QUITE IMPRESSIVE HOW QUICKLY PEOPLE GET ON THAT STEEP LEARNING CURVE AND GET TO THE POINT OF BEING ABLE TO DO THIS ON THEIR OWN, SO RIGHT NOW WE RARELY HAVE ANYBODY AT THE FIRST PLACE WHO WORKS AT REDEMPTION HOSPITAL WORKING IN THE LAB. THAT'S ALL LIBERIAN NOW. THERE'S SOME TECHNICAL ISSUE WE NEED TO LOOK AT, WE'LL HAVE SOMEONE DROP BY BUT THEY ARE WORKING ON THEIR OWN. WE'VE BEEN SO IMPRESSED WITH THIS WE'RE CONTINUALLY TAKING IT UP TO THE NEXT LEVEL, SO THE NEXT THING WE'RE PLANNING TO DO, WE'VE GOT THE LAB SPACE AT JFK, THEIR MAJOR MEDICAL REFERRAL CENTER, WE'RE WORKING WITH DAVID BLUMKE AND AVI NASS, DAVID IN NEUROLOGY, PUTTING IN A SCANNER TO LOOK AT DETAILS, PROBLEMS WE'RE SEEING, WHETHER IT'S PULMONARY OR NEUROLOGIC. WE'VE BEEN VERY IMPRESSED WITH HOW WELL THE LIBERIANS -- IT'S ALMOST -- THERE'S A GREAT APPETITE FOR DOING IT AND PEOPLE ARE WORKING REALLY HARD TO BE ABLE TO DO IT. WE'VE BEEN ABLE TO BE THERE IN AN ADVISORY ROLE AND PULL BACK WHICH ALLOWS US THEN TO GO TO THE NEXT EITHER PHASE OF COMPLEXITY OR THE NEXT SITE. >> THANK YOU. PAMELA, YOU WERE TALKING ABOUT THE DIFFERENT HUBS IN AFRICA YOU'VE BEEN INVOLVED WITH. FROM YOUR EXPERIENCE THERE AND THE IMPRESSION YOU HAVE, GIVEN ALL OF THE OTHER DISEASES, MANY OF WHICH ARE INFECTIOUS DISEASES THAT WE DEAL WITH AT NIAID, IS IT YOUR IMPRESSION THE HEALTH AUTHORITIES IN THE COUNTRY ARE AS INVOLVED AND INVESTED IN ADDRESSING THE MENTAL HEALTH ISSUES IN THOSE COUNTRIES OR IS IT STILL AT A LOW LEVEL OF PRIORITY, AT LEAST FROM THE STANDPOINT OF YOUR PERCEPTION. >> YEAH, THAT'S A GREAT QUESTION. I THINK IT VARIES. I WOULD SAY GHANA RECENTLY PASSED A NEW MENTAL HEALTH ACT, SO THERE'S A LOT OF ENERGY RIGHT NOW AROUND HOW THEY CAN EXPAND MENTAL HEALTH SERVICES IN THE COUNTRY. LAST YEAR THE ETHIOPIAN MINISTER OF HEALTH DECLARED THE ROLLOUT OF MENTAL HEALTH SERVICES THROUGHOUT THE COUNTRY. IT REALLY DEPENDS. IT'S ACTUALLY HARD TO PREDICT WHERE IT GETS THAT KIND OF TRACTION AND WHERE IT DOESN'T BUT THIS IS NOT TRADITIONALLY AN AREA PEOPLE THINK OF WHEN YOU THINK OF GLOBAL HEALTH. OFTEN MINISTERS OF HEALTH HAVE COMPETING PRIORITIES AND OFTEN THEY GO WHERE DONOR FUNDING GOES AS WELL, THERE'S NOT MUCH DONOR FUNDING AROUND MENTAL HEALTH GLOBALLY AS OTHER INFECTIOUS DISEASES AND OTHER THINGS. >> LIBERIA HAS TO DO BETTER THAN ONE PSYCHIATRIST THOUGH, YEAH. >> LIBERIA'S GOT TO DO BETTER. THE CARTER CENTER IS TRAINING PSYCHIATRIC NURSES THERE, SO THEY WILL TO KEEP -- >> KEEP PUSHING. ALL RIGHT. >> OH, QUESTION. SORRY, I DIDN'T SEE YOU. >> THANKS. GIVEN THE NICE DISCUSSIONS FROM BIOTECHNOLOGY, MENTAL HEALTH, INFECTIOUS DISEASE TO ENVIRONMENTAL HEALTH, I WAS THINKING ABOUT THE ROLE OF OUR INTRAMURAL PROGRAMS, IN RESPONDING AND BUILDING INFRASTRUCTURE LIKE WE HAVE BEEN. WHERE DO YOU FORESEE HOW WE MOVE THAT FORWARD BEING ABLE TO DO TIMELY RESEARCH, USING SOME INFRASTRUCTURE WE'RE BUILDING IN A THOUGHT FORWARD WAY IN RESPONSES TO FUTURE SITUATIONS AND DISASTERS AND SOME LESSONS LEARNED THAT YOU MAY HAVE GLEANED FROM YOUR EXPERIENCES? >> CLIFF, YOU ARE THE DEPUTY DIRECTOR FOR SPECIAL PROJECTS. THIS LOOKS LIKE A SPECIAL PROJECT HERE. >> IT'S A VERY GOOD QUESTION, BECAUSE IT'S VERY DIFFICULT TO DO THIS FROM A COLD START. AND WE ACTUALLY HAVE PROGRAMS IN SOUTHEAST ASIA, INDONESIA, MULTIPLE PLACES IN AFRICA, MEXICO, SOUTH AMERICA, EVEN EUROPE, WE HAD NOTHING IN LIBERIA, SIERRA LEONE, OR GUINEA. AND YOU JUST DON'T KNOW WHERE IT'S GOING TO HAPPEN. INTERESTINGLY, WE DID HAVE AS I MENTIONED QUITE A BIT IN MALI, WHEN THE FIRST CASES OCCURRED IN MALI, THEY WERE ABLE TO USE A BSL-3 LAB WE BUILD THERE FOR TB RESEARCH, HINES FELDER WENT FROM THE ROCKY MOUNTAIN LAB AND THEY PUT IN PLACE THE DIAGNOSTIC CAPABILITIES THEY NEEDED FOR EBOLA. THEY CONTROLLED THEIR OUTBREAK, YOU KNOW, EXTRAORDINARILY WELL. IT DIDN'T TURN INTO ANY MORE THAN ONE CLUSTER. SO THE CHALLENGE IS BEING PREPARED WHERE YOU ARE, AND THEN OR BEING READY TO RESPOND. SO WE RESPONDED BECAUSE WE WERE ASKED PARTICULARLY SINCE WE WERE ASKED BY THE SECRETARY, BUT THAT HIGHLIGHTED TO US THAT WE ACTUALLY PROBABLY NEED AT LEAST AN NIAID, AND YOU CAN THINK NIH-WIDE, THE ABILITY TO RESPOND QUICKLY. IN OTHER WORDS HAVING A CADRE OF PEOPLE WHOSE PRIMARY JOB IS TO RESPOND WHEN IT'S TIME TO RESPOND, NOT WHOSE PRIMARY JOB IS SOMETHING ELSE AND HEY WE NEED YOU FOR A RESPONSE NOW. I TALK ABOUT ALL THE PEOPLE WHO WENT OVERSEAS. THERE ARE TWICE AS MANY PEOPLE WHO STAYED HERE FILLING IN FOR THOSE GUYS WHO WENT OVERSEAS WHO ARE ACTUALLY MORE STRESSED AND MORE STRAINED THAN THE STAFF THAT WENT OVERSEAS. WE'RE LOOKING WITHIN NIAID ABOUT WHETHER OR NOT WE MAY BUILD OUT A PIECE OF OUR PROGRAM SUCH THAT IT IS A RAPID DEPLOYMENT FORCE, FOR LACK OF A BETTER WORD. >> DAVID, YOU WERE TALKING ABOUT SEQUENCING AND YOU MENTIONED THE FDA DOING SEQUENCING. SO WE HAVE CDC THAT HAS SEQUENCING CAPABILITY TRACKING MICROBES, YOU GUYS AND THE FDA. HOW DO YOU DIVIDE THE RESPONSIBILITY WHEN YOU WANT TO IMPLEMENT SOME OF THE THINGS YOU SHOWED ON YOUR SLIDE? >> ACTUALLY UNFORTUNATELY WE DON'T HAVE CAPABILITY. WE DO THE COMPUTATIONAL AND BIOINFORMATICS AND DATA MANAGEMENT. NIH HOWEVER HAS TREMENDOUS SEQUENCING CAPACITY, NIAID IS A PRIME PLAYER WITH INFECTIOUS DISEASE AND SEQUENCING. THE THING IS THAT YOU REALLY NEED PEOPLE WHO ARE LOOKING TO GET TO THE GOAL AS FAST AS POSSIBLE, AND NOT NECESSARILY REINVENT THE WHEEL. THE GROUP AT FDA REALLY HAS BEEN VERY FORWARD LOOKING. THEY HAVE WANTED TO MAXIMIZE THEIR CAPABILITIES, BUT COMPLEMENT THEM WHERE NECESSARY AND THEY HAVE REALLY BEEN A GREAT PARTNER, AND ONCE WE STARTED WORKING WITH THEM CDC SAW THE ADVANTAGES AND AGAIN THEY ARE NOT TRYING TO COMPLETELY REINVENT THE WHEEL, WE'RE HANDLING A LOT OF THE COMPUTATIONAL AND DATA MANAGEMENT STUFF FOR THEM AND THEY ARE FOCUSING ON OTHER PARTS OF IT. I FORESEE WITH THE AMR CHALLENGE THAT THEY HAVE GREAT POTENTIAL TO COMPLEMENT EACH OTHER BECAUSE CDC HAS THE SURVEILLANCE AND COLLECTIONS FOR MONITORING AND SO FORTH BUT THEY REALLY DON'T HAVE THE CAPABILITIES WITH CENTERS LIKE BROAD AND JCBI, NIAID HAS BUILT UP, NOR -- NIAID HAS TREMENDOUS RESEARCH OPPORTUNITIES WITH SOME OF THE DATA AND THINGS THAT COME OUT OF THIS PROJECT. AND SO I THINK IT'S -- I THINK THAT'S -- I'M SELLING YOU SOMETHING HERE. BUT I DON'T HAVE TO SELL TOO HARD BECAUSE MARIA IS ENGAGED. THAT I THINK THAT NIAID AND NCBI CAN CONTRIBUTE IN THEIR OWN WAY, CDC IN THEIR SPECIAL WAY AND YOU NEED PARTNERS WILLING TO DISCUSS AND MAKE IT WORK. >> SO LET ME THANK THE PANELISTS. WE'VE COME TO THE END OF THE SESSION. WE CAN'T TAKE ANY MORE QUESTIONS BUT THE DISCUSSION IS JUST BEGINNING. ONE OF THE GOALS OF OUR LONG-TERM PLANNING WAS TO THINK ABOUT WAYS IN WHICH THE NIH COULD MORE EFFECTIVELY HARNESS THE ENORMOUS TALENT WE HAVE HERE TO DEAL WITH PUBLIC HEALTH EMERGENCIES AND I'M HEARING THE BEGINNINGS OF GOOD IDEAS AND WE'LL CONTINUE THESE DISCUSSIONS. ANYONE WHO IS INTERESTED IN JOINING US IS CERTAINLY WELCOME TO. LET ME THANK THE GREAT SPEAKERS AND THE PANELISTS FOR HELPING US TODAY. LET ME REMIND YOU THAT THE RESEARCH FESTIVAL GOES ON. THERE'S -- CURRENTLY THERE'S A POSTER SESSION IN THE FAS TERRACE AND FOOD IF YOU'RE INTERESTED IN HAVING SOMETHING TO EAT AND SEEING THE POSTERS. AND THEN 1:30 WE'LL HAVE OUR WORKSHOPS. IN THIS VERY ROOM THERE'S GOING TO BE A WORKSHOP ON VACCINE DEVELOPMENT AT THE NIH FOR THOSE OF YOU WHO HAVE PUBLIC HEALTH INTERESTS. SO THANKS A LOT, AND CONTINUE TO ENJOY THE RESEARCH FESTIVAL. [APPLAUSE] [END OF PROGRAM]