>> GOOD MORNING AND WELCOME TO THE 182ND COUNCIL OF THE INSTITUTE OF INFECTIOUS DISEASES. WE'RE JOINED BY REPRESENTATIVES FROM PROFESSIONAL AND LAY ORGANIZATIONS WHO SHARE INTERESTS AND ACTIVITIES IN COMMON WITH THE MISSION OF THE INSTITUTE. AS ALWAYS, WE WELCOME THEM. I WOULD ALSO LIKE TO WELCOME OUR SIX NEW COUNCIL MEMBERS. DR. ANDINO. PROFESSOR OF THE DEPARTMENT OF IMMUNOLOGY AT UCSF. DR. WENDY BOOK IS PROFESSOR OF MEDICINE AT EMERY WHICH DIRECTOR OF THE EMERY DOCUMENT CONGENITAL HEART CENTER. DR. SALLY HOTTER, WEST VIRGINIA UNIVERSITY AND DIRECTOR OF THE WEST VIRGINIA CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE. DR. KAREN NELSON IS PRESIDENT OF THE J. CRAIG CENTER INSTITUTE IN ROCKVILLE, MARYLAND AND DR. KAHA WILSON. PROFESSOR OF INFECTIOUS DISEASES AT THE UNIVERSITY OF COLORADO AT DENVER. AND THREE AD HOC COUNCIL MEMBERS WHO ARE WITH US TODAY. DR. BUTLER, PROFESSIONAL PROFESSOR OF IMMUNOLOGY AND DIRECTOR OF THE CENTER OF HOST EVENTS. DR. RALPH BARRACK, PROFESSOR OF EPIDEMIOLOGY IN THE GILLING SCHOOL OF GLOBAL PUBLIC HEALTH AT THE UNIVERSITY OF NORTH CAROLINA AND DR. MARK FINEBURG IS PRESIDENT AND C.E.O. OF THE INTERNATIONAL AIDS VACCINE INITIATIVE. I NOW WOULD LIKE TO BRING YOU UP TO DATE ON KEY APPOINTMENTS AND TRANSITIONSES. IN SEPTEMBER, DR. MICHAEL LAWER WHO SERVED AS THE DIRECTOR OF THE DIVISION OF CARDIOVASCULAR SCIENCES WAS APPOINTMENTS IH DEPUTY DIRECTOR OF EXTRA MURAL RESEARCH, FILLING THE VACANCY LEFT BY SALLY ROCKY'S DEPARTURE. DR. LOWYER CAME. HIS RESEARCH INCLUDES CARDIOVASCULAR EPIDEMIOLOGY, COMPARATIVE EFFECTIVENESS AND BIOSTATISTICS. HE ALSO IS A STRONG ADVOCATE OF HUMAN SUBJECTS PROTECTION. I WOULD NOW LIKE TO TAKE A FEW MINUTES TO PAY TRIBUTE TO DR. CARROLL HIMLAN, WHO STEPPED DOWN NEXT MONTH OF THE DIRECTOR OF THE DIVISION OF MICRO BIOLOGY AND INFECTIOUS DISEASES. DR. IVORY REIN GLOWINSKY WHO WAS BEEN SERVING AS DEPUTY DIRECTOR SINCE 2007 HAS AGREED TO SERVE AS ACTING DIRECTOR, UNTIL A NEW DIRECTOR IS NAMED. SINCE BECOMING DEAN OF DIRECTOR IN 1999, CAROL HAS SERVED WITH GREAT DISTINCTION. MANAGING A COMPLEX NATIONAL AND INTERNATIONAL RESEARCH PROGRAM AND INFECTIOUS DISEASES ON MORE THAN THREE HUNDRED ORGANIZATIONS. UNDER CAROL'S LEADERSHIP, EXPANDED ITS RESEARCH INFRASTRUCTURE TO INCLUDE NATIONAL AND REGIONAL BIOCONTAINMENT LEGIBILITIES WHICH INCREASE OUR CAPACITY TO RESPOND QUICKLY TO PUBLIC HEALTH CHALLENGES, INCLUDING THE POTENTIAL BIOTERRORIST ATTACK. AMONG MANY ACCOMPLISHMENTS, DURING CAROL'S TENURE, DIMID PLAYED AN A CRITICAL ROLE IN THE GAMBIAN FUMEO COCKEL -- IN AFRICA. SPEARHEADED CLINICAL TRIALS OF A VACCINE AGAINST A 2009H1N1 INFLUENZA VIRUS. CAROL JOINED NIAID IN 1986 AND WORKED IN VARIOUS POSITIONS INCLUDING DEPUTY DIRECTOR OF THE DIVISION OF AIDS. SHE HAS RECEIVED NUMEROUS AWARDS FOR SCIENTIFIC MANAGEMENT AND LEADERSHIP, INCLUDING THREE HHS SECRETARIES AWARD FOR DISTINGUISHED SERVICE. I'D LIKE TO THANK CAROL FOR OUR OUTSTANDING SERVICE TO NIAD AND NIH. I WILL MISS HER AS A COLLEAGUE, AN ADVISER AND A FRIEND. HER LEGACY WILL ENDURE FOR MANY YEARS AND WE WILL BE HONORING HERE AND CELEBRATING HER CONTRIBUTIONS IN THE COMING WEEKS. IN OCTOBER, DR. ERNIE TAK AFGI DIRECTOR OF THE OFFICE OF BIORESEARCH, RETIRED FROM FEDERAL SERVICE AFTER MORE THAN 13 YEARS WORKING AT NIAID. OBR HELPED COORDINATE BIODEFENSE RESEARCH EFFORTS ACROSS THE NIH AND WITH OTHER AGENCIES. WITH ERNIE'S GUIDANCE, NIH BEGAN ITS CHEMICAL COURT RESEARCH METHODS IN 2005. WE ARE CURRENTLY CONDUCTING A SEARCH FOR A DIRECTOR OF THE NEWLY RESTRUCTURED OFFICE OF BIODEFENSE RESEARCH INSURETY. IT IS NOW MY PLEASURE TO ANNOUNCE FOUR SPECIAL RECOGNITIONS. IN OCTOBER, DR. CLIFF LANE, DEPUTY DIRECTOR FOR CLINICAL RESEARCH AND SPECIAL PROJECTS AND DIRECTOR OF THE DIVISION OF CLINICAL RESEARCH, RECEIVED THE 2015 DISTINGUISHED ACHIEVEMENT AWARD FROM THE UNIVERSITY OF MICHIGAN MEDICAL CENTER ALUMNI SOCIETY. SINCE 1979, WHEN CLIFF JOINED THE INSTITUTE, HE HAS SERVED IN MANY CAPACITIES, INCLUDING HIS WORK AS A RESEARCH SCIENTIST IN THE LEGIBILITY OF IMMUNOREGULATION AS DEPUTY CLINICAL DIRECTOR, CHIEF OF THE LAR CLINICAL AND MOLECULAR RETROBIOLOGY SECTION, A POSITION HE STILL HOLDS AND AS CLINICAL DIRECTOR. CLIFF IS ALSO OUR LIAISON WITH THE U.S. DEPARTMENTS OF DEFENSE AND HOMELAND SECURITY. MOST RECENTLY, HE HAS ABLY LED NAID'S EBOLA CLINICAL TRIALS PARTNERSHIP IN WEST AFRICA, PRIMARY FOCUSING ON LIBERIA. SADLY, DESPITE HIS MANY PROFESSIONAL ACCOMPLISHMENTS AND HIS SPECIAL RECOGNITION BY THE UNIVERSITY OF MICHIGAN, CLIFF HAS NOT BEEN ABLE TO PASS HIS SUCCESS ALONG TO HIS ALMA MATER'S FOOTBALL TEAM. IN OCTOBER, DR. DAVID MORAN, SENIOR SCIENTIFIC ADVISER AND THE OFFICE OF DIRECTOR WAS LEAKED AS A FELLOW OF THE AMERICAN SOCIETY OF TROPICAL MEDICINE AND HYGIENE. THE HONOR RECOGNIZES SUSTAINED PROFESSIONAL EXCELLENCE IN TROPICAL MEDICINE, GLOBAL HEALTH AND RELATED DISCIPLINES. DR. PETER COMPTON, CHIEF OF THE MALARIA INFECTION BIOLOGY AND IMMUNITY UNIT, HAS BEEN AWARDED THE BAILEY K. ASHFORD MEDAL FOR DISTINGUISHED WORK IN TROPICAL MEDICINE BY A MID-CAREER PROFESSIONAL. PETER'S RESEARCH FOCUSES ON UNDERSTANDING HUMAN IMMUNE SPONSES, INCLUDING THE DEVELOPMENT OF NATURALLY ACQUIRED IMMUNITY. MIKE TARTKOFSKY HAS RECEIVED THE 2015 MERIT ORUOUS EXECUTIVE RANKED AWARD, ONE OF ONLY TWO CATEGORIES OF PRESIDENTIAL RANK AWARDS. SINCE 2003, MIKE HAS LED EFFORTS TO DELIVER TO NIAID, STATE OF THE ART, I.T. INFRASTRUCTURE. CUSTOM SOFTWARE APPLICATIONS, BIOINFORMATIC TOOLS AND BUSINESS ANALYTICS. I WILL NOW TELL YOU ABOUT SOME RECENT MEETINGS AND EVENTS OF INTEREST. ON SEPTEMBER 28, A DELEGATION FROM THE BRAZILIAN MINISTRY OF HEALTH VISITED THE NAIAID VACCINE RESEARCH CENTER. I WELCOMED THE DELEGATION, DRC DIRECTOR PROVIDED AN OVERVIEW OF THE VRC RESEARCH AND DR. BARNEY GRAHAM DESCRIBED THE STUDIES, FOCUSED ON DEVELOPING RESPIRATORIES VIRUS, AS WELL AS CHICKEN GUNNIA VACCINES. LAST SUMMER, YANG HAZE HE CHOY, THE KOREAN MINISTER OF COMMUNICATIONS TECHNOLOGY AND FUTURE PLANNING, VISITED NIH. AT THE TIME, MINISTER CHOY AND I DISCUSSED EXPANDING NIH CAREER COOPERATION, FOCUSED ON INFECTIOUS DISEASES, INCLUDING THE MIDDLE EAST RESPIRATORY SYNDROME OR MAYORS, WHICH HAS CAUSED THE PUBLIC HEALTH CRISIS IN SOUTH KOREA. ON OCTOBER 16, SHOWN ON THIS SLIDE, A SIMILAR KOREAN DELEGATION INCLUDING DR. YU Y SHI LEE. DIRECTOR OF THE KOREAN NATIONAL INSTITUTE OF HEALTH, HAVE THED THE NIH. ALSO DURING THE OCTOBER VISIT, DR. COLLINS SIGNED A BROAD LETTER OF INTENT, WITH THE KOREAN NIH TO DO LABRATE AND INTERACT WITH NIH ON THE PRECISION MEDICINE INITIATIVE AND MERIS CORONA VIRUS. ON OCTOBER 30, THREE MEMBERS OF THE SCIENTIFIC DELEGATION FROM CUBA VISITED NIH. ALL WERE FEATURED SPEAKERS IN THE SYMPOSIUM SPONSORED BY THE AMERICAN SOCIETY OF TROPICAL MEDICINE AND HYGIENE AND THE PAN AMERICAN HEALTH ORGANIZATION ENTITLED "CUBA-U.S.: BUILDINGS BRIDGES THROUGH SCIENCE AND GLOBAL HEALTH." DESPITE LONG-STANDING RESTRICTIONS ON U.S.-CUBA INTERACTION, THAT WERE EASED IN DECEMBER 2014, WHEN PRESIDENT OBAMA ANNOUNCED THE NORMALIZATION OF RELATIONS WITH CUBA, THE TWO COUNTRIES HAVE FOUND WAYS TO COLLABORATE ON MULTIPLE HEALTH AND SCIENCE PROJECTS. THE PURPOSES OF THE RECENT MEETING WERE TO SERVE AS AN OPPORTUNITY TO MEET OUR CUBAN COLLEAGUES, AND TO IDENTIFY MUTUAL INTERESTS AND PRIORITIES. ON NOVEMBER 9, I PARTICIPATED IN A PANEL DISCUSSION WHICH WAS ENTITLED "U.S. NATIONAL SECURITY BENEFITS FROM GLOBAL HEALTH." DURING A MEETING AT THE BIPARTISAN CENTER CONFERENCE, ON STRATEGIC HEALTH DIPLOMACY. THE CENTER WAS FOUNDED IN 2007 AND IS CURRENTLY HEADED BY FORMER SENATORS TOM DASH, AND BILL FRIST. "WASHINGTON POST" COLUMNIST, MIKE GURSEN SHARED THE SESSIONS AND I DISCUSSED THE ORIGINS AND SUCCESS OF PEPFA, THE PRESIDENT'S PLAN ON EMERGENCY AID AND RELEASEE OF 2015, THE PROGRAM HAS SUPPORTED ANTIVIRAL TREATMENT FOR -- ON NOVEMBER 19, I DELIVERED A TED MED TALK IN PALM SPRINGS AT THE SESSION ON CANALIZING GREAT SCIENCE. I DESCRIBED OUR HOWE IN THE EARLY YEARS OF THE HIV/AIDS EPIDEMIC, I CHOSE TO EMBRACE FLEXIBILITY IN CONDUCTING RESEARCH, IN ORDER TO MAINTAIN THE DELICATE BALANCE OF ADVANCING SCIENCE WHILE ALSO ADDRESSING THE URGENT NEEDS OF PEOPLE WITH HIV/AIDS. ON DECEMBER 15, AMBASSADOR AT LARGE, DR. DEBRA BURKS DELIVERED THE 2015 JOSEPH J.KINUNE MEMORIAL LECTURE. AT THE U.S. GLOBAL AIDS COORDINATOR AND UNITED STATES SPECIAL REPRESENTATIVE FOR GLOBAL HEALTH DIPLOMACY, DR. BURKS OVERSEES THE IMPLEMENTATION OF PEPFAR. IN THE PRESENTATION AT NIH. DR. BURKS DESCRIBED HOW THE USE OF DATA GATHERED BY PEPFAR HAS BEEN CRITICAL FOR UNDERSTANDING LOCAL HIV PREVALENCE, DETERMINING THE QUALITY AND COST OF SERVICES AND DEFINING KEY GAPS. SHE ALSO DISCUSSED HOW PEPFAR IS WORKING WITH HOST COUNTRIES TO USE THESE DATA TO REFOCUS PROGRAMS FOR MAXIMUM IMPACT. ON DECEMBER 16, NIH RELEASED ITS 2016-2020 STRATEGIC PLAN, TURNING DISCOVERY INTO HEALTH. THE PLAN WAS DEVELOPED AFTER HEARING FROM HUNDREDS OF STAKEHOLDERS AND SCIENTIFIC ADVISERS AND IN COLLABORATION WITH THE LEADERSHIP AND STAFF OF NIH INSTITUTES CENTERS AND OFFICES. IT IS DESIGNED TO COMPLEMENT THE ICO'S INDIVIDUAL STRATEGIC PLANS AND ARE ALIGNED WITH THEIR CONGRESSIONALLY MANDATED MISSIONS. THE PLAN DESCRIBES KEY OBJECTIVES AND ALSO IDENTIFIES GOALS FOR THE NEXT FIVE YEARS, INCLUDING THE INTEREST OF NIAID, SUCH AS LAUNCHING CLINICAL TRIALS ON UNIVERSAL INFLUENZA CANDIDATES, MAKING PROGRESS IN FIELD TEST OF A CANDIDATE VACCINES AGAINST RESPIRATORY STITIAL VIRUS AND ACHIEVING AT LEAST 50% PROTECT AGAINST HIV IN A PIVOTAL VACCINE WHILE, SLATED TO BEGIN IN SOUTH AFRICA IN 2016. ON JANUARY 11, I DELIVERIED THE KEYNOTE PRESENTATION AT THE 18TH INTERNATIONAL CONGRESS ON EMERGING INFIXES DISEASES IN THE PACIFIC RIM AND NIH ORGANIZED EVENT, COMMEMORATING THE 50TH ANNIVERSARY OF THE U.S.-JAPAN, COOPERATIVE MEDICAL PROGRAM. A RECEPTION HELD AT THE NATIONAL ACADEMY OF SCIENCES WAS ATTENDED BY SEVERAL HUNDRED PARTICIPATES, AND SCIENTIFIC MEETINGS PRECEDED THE REST OF THE WEEK. I ALSO ANNOUNCED A NEW PROGRAM FOR COLLABORATIVE PROJECT SUPPORT BETWEEN NIH AND THIA PAN AGENCY FOR MEDICAL RESEARCH AND DEVELOPMENT, WHICH IS CALLED AMED TO, DEMONSTRATE CONTINUING COMMITMENT TO THE U.S. JAPAN PROGRAM. OTHER KEY OFFICIALS FROM BOTH COUNTRIES INCLUDING NIH DIRECTOR, FRANCIS COLLINS, PARTICIPATED IN THE 50TH ANNIVERSARY EVENT. THE U.S.-JAPAN COOPERATIVE MEDICAL SCIENCES PROGRAM, ESTABLISHED IN 1965, IS ONE OF THE OLDEST BILATERAL INITIATIVES AT HHS AND MARKS OUR COUNTRY'S ORIGINAL ENGAGEMENT IN GLOBAL HEALTH DIPLOMACY. NOW I WOULD LIKE TO TAKE A FEW MINUTES TO UPDATE YOU ON OUR BUDGET. THE PRESIDENT'S FISCAL 2017 PRESIDENT BUDGET IS EXPECTED TO BE RELEASED ON FEBRUARY 9. I CANNOT DISCUSS THE FISCAL 2017 BUDGET PRIOR TO ITS RELEASE BY THE PRESIDENT, SO I WILL REVIEW IMPORTANT ASPECTS OF THE 2016 BUDGET. AS MOST OF YOU KNOW, THE PRESIDENT RECENTLY SIGNED THE FISCAL 2016 OMNI MOVER KNEE BUS SPENDING BILL, THAT ALLOCATE ALLOCATE -- THIS SLIDE COMPARES THE FISCAL BETWEEN THE 16, ENACTED BUDGET, WITH THE FISCAL 2015 ENACTED BUDGET. NIH RECEIVED AN INCREASE OF 6.6% IN THE FISCAL 2016 ENACTED BUDGET WITH INSTITUTE INCREASES THAT RANGED BETWEEN 3.9 AND 3 THEE .4%. THE VARIATION WAS A RESULT OF EARMARKS, SUCH AS THE SUPPORT OF ALZHEIMER'S DISEASE RESEARCH AND OTHER BRAIN INITIATIVE, WHICH WERE ALLOCATED TO SPECIFIC INSTITUTES NAIAD'S EARMARK WAS LIMITED TO A HUNDRED MILLION DOLLARS FOR ANTIMICROBIAL RESISTANCE RESEARCH, AND THE SUPPORT OF THE PRESIDENT'S COMBATING BACTERIA INITIATIVE. THIS SLIDE SHOWS OUR FINANCIAL MANAGEMENT PLAN FOR FISCAL 2016. IN GENERAL, IT MIRRORS THE FISCAL 2015 PLAN BUT EXPANDS THE PAULINS TO THE 13THS FOR AISLE FOR ESTABLISHED INVEST GATORS, AND THE 17TH PERCENTILE NEW INVESTIGATORS. THESE LEVELS SUPPORT THE NIH POLICY, INDICATING THAT THE SUCCESS RATES FOR NEW AND ESTABLISHED INVESTIGATORS, SHOULD BE ABOUT THE SAME. SUPPORT FOR COMPETING NIAID PROGRAM INITIATIVES, REMAINS AT LEVELS THAT PREVIOUSLY WERE CUT BY UP TO 10% IN ORDER TO SUSTAIN INVESTIGATOR-INITIATED AWARDS. FUNDS FOR FOUR YEAR SELECT PAY AWARDS AND BRIDGE AWARDS WILL BE UNCHANGED FOR PRIOR YEARS AS SHOWN ON THE BOTTOM OF THE SLIDE. NOT SHOWN ON THIS SLIDE IS THAT NIAID'S PLANNED INCREASE FOR RESOURCE PORTFOLIO IS 6.8% OVER FISCAL 2015, AS COMPARED TO A 4% INCREASE FOR INTRAMURAL RESEARCH. THIS SLIDE SHOWS THE FUNDING TREND FOR NIAID DURING THE PAST 15 YEARS. AS YOU CAN SAY, NIAID RECEIVED BUDGET INCREASES FOR SEVERAL YEARS, INCLUDING FOR FUNDS FOR BIODEFENSE RESEARCH IN 2003, WHICH RESULTS IN THAT INCREASE IN THE BLUE BAR YOU SEE ON 2003. THE NIAID BUDGET HAS BEEN RELATIVELY FLAT EVER SINCE. THE BOTTOM LINE IS THAT OUR BUDGET, EVEN WITH THE HEALTHY INCREASE IN 2016 LIKE THAT OF OTHER INSTITUTES, HAS BEEN ESSENTIALLY FLAT FOR MORE THAN 10 YEARS. WHEN WE FACTOR IN THE COST OF INFLATION FOR BIOMEDICAL RESEARCH, OUR FLAT BUDGET AMOUNTS TO A DECREASE IN PURCHASING POWER OF MORE THAN 20%. NOW, I WOULD LIKE TO DISCUSS SEVERAL LEGISLATIVE ITEMS OF INTEREST. AS YOU ARE AWARE, THERE OF COURSE SOME UNEXPECTED LEADERSHIP CHANGES IN THE HOUSE OF REPRESENTATIVES SENSE WE LAST MET. REPRESENTATIVE JOHN BOEHNER, SPEAKER OF THE HOUSE RESIGNED FROM CONGRESS, EFFECTIVE OCTOBER 31ST. ON OCTOBER 29TH, REPRESENTATIVE PAUL RHINE WAS REACTED AS HIS REPLACEMENT. WE LOOK FORWARD TO WORKING WITH SPEAKER RYAN, AND APPRECIATE THE ROLL HE PLAYED SECURING THE NIH BUDGET INCREASE IN THE O -- OMNI BILL I JUST DESCRIBED. CONGRESS CONTINUES TO EXPRESS A SMALL INTEREST IN THE NIAID RESEARCH PROGRAM. SINCE WE LAST MET, THE INSTITUTE HAS ENJOYED SEVERAL INTERACTIONS FOR MEMBERS OF CONGRESS AND CONGRESSIONAL COMMITTEE STAFF. HERE IS AN UPDATE. ON NOVEMBER 5, AT THE REQUEST OF UN -- PARTICIPATED IN A BRIEFING ON FAST TRACKING THE END OF AIDS. WHICH WAS COSPONSORED BY SENATOR ED MARKIE. DURING THE EVENT, I DISCUSSED THE SCIENTIFIC PROGRESS AND EVIDENCE THAT MAKES ACHIEVING EPIDEMIOLOGIC CONTROL AND ENDING THE AIDS PANDEMIC, AS FEASIBLE GOALS. THESE SCIENTIFIC ACHIEVEMENTS WOULD NOT HAVE BEEN POSSIBLE WITHOUT THE SUSTAINED CONGRESSIONAL INVESTMENTS IN NIH RESEARCH ON HIV-AIDS. AMONG OTHERS, SENATORS BOB CALKER AND BENECARTON, REPRESENTATIVES JIM HEINZ AND BARBARA LEE. JANNA LIASON. MICHELLE SEBAY AND UN UNDERSECRETARY ITEM AND AMBOSS DEPARTMENT OF ROADS BURKS SPOKE THE ASSESSMENT. I WAS ON IT TO PARTICIPATE IN THIS BRIEFING, WHICH WAS URN CORED, THE IMPORTANCE OF CONTINUED U.S. INVESTMENT IN HIV/AIDS RESEARCH AS WELL AS GLOBAL IMPLEMENTATION OF AIDS TREATMENT AND PREVENTION TOOLS MANY OF WHICH NIAID HAS HELPED TO DEVELOP. ON NOVEMBER 17, AT THE REQUEST FOR ACT FOR NIH, AN ORGANIZATION WORKING TO INCREASE AWARENESS OF THE IMPORTANCE OF NIH RESEARCH, I BRIEFED STAFF TO THE SENATE AND HOUSE APPROPRIATIONS AND AUTHORIZING COMMITTEES, ON PROGRESS TOWARDS THE DEVELOPMENT OF UNIVERSAL FLU AND H.I.V. VACCINES AND UPDATED THEM ON DEVELOPS, RESULTING ON NIH'S EBOLA RESEARCH. SENATOR LINDSAY GRAHAM, CHAIR OF THE NIH CAUCUS, CO-SPONSORED IN EVENT. DEPRIVING WAS AN EXCELLENT OPPORTUNITY TO MEET WITH SEVERAL IMPORTANT CONGRESSIONAL STAFF TO DISCUSS THE SIGNIFICANCE AND PROMISE OF NIAID RESEARCH AND RESEARCH FINDING. NIAID GRANTEE DR. JAMES CROW OF VANDERBILT, ALSO SPOKE AT THE EVENT. I WOULD NOW LIKE TO RECOGNIZE NIAID STAFF, WHO HAVE PARTICIPATED IN CONGRESSIONAL BRIEFINGS SINCE OUR LAST MEETING. ON NOVEMBER 12, DR. CAROL HARL IN, BRIEFED BIPARTISAN STAFF, TO THE HOUSE, ENERGY AND COMMERCE COMMITTEE, OVERSIGHT COMMITTEE ON INVESTIGATIONS, ON THE NIAID INFLUENZA PROGRAM, INCLUDING PROGRESS ON AN DEVELOPMENT OF A VACCINE. THE BRIEFING WAS HELD PRIOR TO THE SUBCOMMITTEE'S NOVEMBER 19 HEARING, ON U.S. PUBLIC PAIREDNESS FOR SEASONAL INFLUENZA, AT WHICH DR. HEILMAN TESTIFIED. I WILL NOW PROVIDE A VERY QUICK UPDATE ON CONGRESSIONAL UPDATES TO DEVELOP LEGISLATION AIMED AT ADVANCING MEDICAL RESEARCH AND INNOVATION. AS YOU MAY RECALL, LAST YELL, THE HOUSE PASSED THE 21ST CENTURY CURES ACT, WHICH WOULD REAUTHORIZE NIH AND CREATE THE NIH CURES INNOVATION FUND, THE FUND IS DESIGNED TO PROVIDE 1.7 BILLIONA YEAR, IN MANDATORY SUPPORT TO NIH OVER A FIVE-YEAR PERIOD, FOR HIGH-RISK, HIGH- REWARD, BIOMEDICAL RESEARCH, CONDUCTED BY EARLY STAGE INVESTIGATORS AND DEVELOPMENT FOR MORE EFFECTIVE TREATMENTS FOR UNMET MEDICAL NEEDS, INCLUDING ANTIBIOTICS, AND OTHER THERAPEUTICS FOR INFECTIOUS DISEASES. FOR SEVERAL MONTHS, WORKING ON INITIATIVE ALTHOUGH NO COMPREHENSIVE COMPANION LEGISLATION HAS BEEN INTRODUCED. JUST LAST WEEK, HOWEVER, THE SENATE HEALTH COMMITTEE ANNOUNCED THAT STARTING ON FEBRUARY 9, IT WILL BEGIN MARKING UP A SERIES OF INDIVIDUAL BILLS, DESIGNED TO ADVANCE MEDICAL INNOVATION, INCLUDING LEGISLATION SUPPORTING THE PRESIDENT'S PRECISION MEDICINE INITIATIVE. AT THIS TIME, IT IS DIFFICULT TO PROTECT THE OUTCOME OF THESE LEGISLATIVE EFFORTS AND THEIR IMPLICATIONS FOR THE NIH. I WILL DEDICATE THE REMAINDER OF THE SESSION TO A DISCUSSION OF OTHER ISSUES THAT HAVE A RISEN, EVENTS HAVE OCCURRED AND FOLLOW-UP OF MATTERS WE HAVE PREVIOUSLY DISCUSSED, THEY BELIEVE MIGHT BE OF INTEREST TO YOU LET'S START OFF WITH E BOWL A. AS YOU PROBABLY KNOW, THE EBOLA OUT BREAK, IN WEST AFRICA IS ESSENTIALLY UNDER CONTROL WITH THE TOTALS NOW, AT THE END OF THE EPIDEMIC, BEING OVER 28,000 CASES WITH MORE THAN 11,000 DEATHS. WE PARTICIPATED IN A SIGNIFICANT MANNER IN THE RESEARCH ENDEAVOR, WHICH WE TITLED "PREVAIL" OR THE PARTNERSHIP FOR RESEARCH ON EBOLA VIRUS IN LIBERIA, WHICH WAS ACTUALLY A CLINICAL RESEARCH PARTNERSHIP BETWEEN THE LI BEERIAN MINISTRY OF HEALTH AND UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES. THERE WERE THREE ON GOING STUDIES. PREVAIL 1, CHAMPIONS A VACCINE TRIAL. PREVAIL 2, WHICH WAS A TREATMENT TRIAL AND PREVAIL 3, WHICH WAS A SURVIVOR, AND A SURVIVOR NATURAL HISTORY STUDY. ON JANUARY 18 AND 19, CLIFF LANE AND I VISITED THE SITES IN LIBERIA. SEVERAL PICTURES OF US ARE SHOWN ON THIS SLIDE. DR. LANE, AS I'VE TOLD YOU BEFORE, HAS PLAYED AN ENORMOUS ROLE, NOT ONLY IN ORGANIZING THE CLINICAL STUDY ITS, BUT BEING RESPONSIBLE FOR THE RENOVATING AND THE DEVELOPMENT OF INFRASTRUCTURE AT THE LEAST TWO SITES IN MONROVIA. THE REDEMPTION HOSPITAL AND THE J.F.K. HOSPITAL. ON THIS SLIDE. YOU CAN SEE DR. LANE AND I AND OTHERS, TALKING TO OUR COLLEAGUES IN LIBERIA. ON THE LOWER RIGHT, I MET WITH THE UNITED STATES AMAMBASSADOR TO LIBERIA, AND WE TALKED ABOUT THE IMPORTANCE OF CONTINUING THE SUSTAINED COLLABORATION BETWEEN OUR COUNTRIES. LET ME VERY BRIEFLY DESCRIBE SOME OF THE ACTIVITIES UNDER THE DIFFERENT PREVAIL PROTOCOLS. AS I MENTIONED, PREVAIL 1 IS A VACCINE TRIAL. IT IS NOW A PHASE 2 ORIGINALLY RANDOMIZED PLACEBO CONTROLLED TRIAL OF THE GLAXOSMITHKLINE CHIP ADNO, TOGETHER WITH THE NEW LINK, DSV CANDIDATE. IT WAS LAUNCHED ON FEBRUARY TWO 2015 IN LIBERIA, BUT DUE TO THE DECLINING CASES, WHAT WAS ORIGINALLY SCHEDULED TO BE A PHASE III EFFICACY TRIAL WAS CONVERTED TO A PHASE II SAFETY, IMMU NO GENICITY STUDY. THERE WERE 15 VOLUNTEERS ENROLLED BY APRIL OF 2015. THE IMMU NO GENICITY AND FOLLOW UP IS EXPECTED TO CONCLUDE IN THE SPRING OF 2016 AND ANTIBODY LEVELS ARE BEING MEASURED IN LIBERIA, AS PART OF OUR TRYING TO HELP THEM IN THEIR CAPACITY BUILDING. DURING MY VISIT, WE HAD THE OPPORTUNITY TO CELEBRATE WITH THEM, THE ONE-YEAR FOLLOW-UP OF THE PREVAIL VACCINE TRIAL, AT WHICH POINT, INDIVIDUALS WERE GIVEN A CERTIFICATE OF APPRECIATION AND THESE ARE SOME PICTURES HERE, AT THE REDEMPTION HOSPITAL, SHOWING THE FOLLOW-UP STUDIES OF THAT PREVAIL 1 VACCINE TRIAL. WITH REGARD TO THE PREVAIL 2 TREATMENT TRIAL. THIS IS A RANDOM ICED CONTROL TRIAL OF OPTIMIZED STANDARD OF CARE VERSUS OPTIMIZED STANDARD OF CARE PLUS 0NAC. THE COCKTAIL OF THREE MONOCLONAL ANTIBODIES AGAINST EBOLA FLUKEO PROTEIN. THE TRIAL -- -- GLYCO PROTEIN. THE TRIAL OPENED IN FEBRUARY 2014 AND CITES WERE ENROLLED HERE IN THE -- SITES WERE ENROLLED HERE IN LIBERIA, SIERRA LEONE AND GEANY. WE PLANNED TO CLOSE ENROLLMENT AND DID IN JANUARY, 2016, AFTER 72 INDIVIDUALS WERE ENROLLED. THE DATA AND SAFETY MONITORING BOARD HAS NOW GONE OVER THE DATA AND WE ARE IN THE PROCESS OF ANALYZING IT AND HOPEFULLY, WE WILL HAVE RESULTS THAT WILL BE REPORTABLE IN A REASONABLE PERIOD OF TIME. WITH REGARD TO PREVAIL 3, WHICH IS THE SURVIVOR NATURAL HISTORY STUDY, THAT IS A PROTOCOL WHICH IS FOLLOWING EBOLA SURVIVORS, AS WELL AS THEIR CLOSE CONTACTS AND WE'RE LOOKING AT THE SEQUELER OF DISEASE, AND THE POSSIBILITY OF VIRAL PERSISTENCE IN BODILY FLUIDS, SUCH AS SEMEN, AS WELL AS INCEREBRAL SPINAL NUDE, WE RELATE IT TO THE FACT OF A CASE OF AN IRISH NURSE CASE STUDY THAT RELAPSED. WE HAD GOOD COOPERATION WITH OTHER NIH INSTITUTES. THE NATIONAL EYE NEWT AND THE NEUROLOGY INSTITUTE PARTICIPATED IN OCULAR AND NEUROLOGY SUBSTUDIES AND WE HAVE NOW HAD CLOSE TO 2,000 INDIVIDUALS WHO HAVE BEEN ACCRUED INTO THE STUDY, INCLUDING OVER A THOUSAND SURVIVORS AND OVER 8,000 CONTACTS HAVE BEEN ENROLLED. LET'S MOVE ON. TO A QUICK FOLLOW-UP OF HRD AIDS. AS YOU KNOW, THE CDC HAS BEEN, AS WE ALL HAVE, BEEN TRYING TO PUSH THE AWARENESS OF THE UTILIZATION OF THE HIGHLY EFFECTIVE PREEXPOSURE PROP LGBT ACTIVISTSIC OR PREP, A DAILY PIT, WHICH CONTAINS -- WHICH CAN ACTUALLY REDUCE THE RISK OF GETTING H.I.V. FROM SEXUAL CONTACT BY 90% ABOUT 25% OF GAY BISEXUAL MEN, 20% OF ADULT WHO IS INJECT DRUGS AND ONE IN 200 HETEROSEXUAL ARE WHAT THE C.D.C. CONSIDERS, AT SUBSTANTIAL RISK FOR H.I.V. INFECTION AND MIGHT BENEFIT GREATLY P.R.E.P. HOWEVER IT IS DISTURBING THAT YET ONE IN THREE PRIMARY CARE DOCTORS AND NURSES ARE COMPLETELY UNAWARE OF P.R.E.P. SO IT'S CLEAR THAT WE HAVE TO DO A BETTER JOB OF LETTING THE BENEFITS OF THIS KNOWN MORE WIDELY. THE NIH HAS RECENTLY LAUNCHED AN INITIATIVE TO DEVELOP LONG-ACTING H.I.V. TREATMENT AND PREVENTION TOOLS AND WE HAVE DONE THIS IN A 5-YEAR CREATED PARTNERSHIP BETWEEN THE VACCINE RESEARCH CENTER AND GLAXOSMITHKLINE, TO IDENTIFY COMBINATIONS OF BROADLY NEUTRALIZING ANTIBODY, THAT BLOCK THE WIDEST RANGE OF H.I.V. STRAINS, AS WELL AS TO DO THIS IN COMBINATION WITH ANTI-RETROVIRAL DRUGS. TOM FREED CAPITAL IMPROVEMENT AND I IN THE SAME ISSUE, THE DECEMBER 3 ISSUE "THE NEW ENGLAND JOURNAL OF MEDICINE", PUBLISHED COMMENTARIES, MIND ON THE SCIENTIFIC BASIS OF WHY WE'LL BE ABLE TO END THE HIV AIDS PANDEMIC, AND TOM, DOING A LOOK AT HOW HAVE WE FOLLOWED THE PUBLIC HEALTH PRINCIPLES IN THE HIV-AIDS EPIDEMIC. THESE WERE TWO PIECES IN THE NEW ENGLAND JOURNAL THAT HAVE BEEN VERY WELL RECEIVED. REGARDING MY EMPHASIS ON THE SCIENCE, I DESCRIBED VERY BRIEFLY, AND OF COURSE DOING SO AT VARIOUS MEETINGS, THREE PIVOTAL STUDIES WHICH FORMED THE SCIENTIFIC BASIS OF WHY WE THINK WE CAN END THE EPIDEMIC AS WE KNOW IT, WITHIN A REASONABLE PERIOD OF TIME. THE FIRST WAS THE SMART STUDY, WHICH CLEARLY SHOWED THAT CONTINUAL TREATMENT WITH ANTI-RETROVIRALS, AS OPPOSED TO TRYING TO SPEND AS MUCH TIME, OFF AND RETROVIRALS AS POSSIBLE, WAS MUCH MORE BENEFICIAL. IN FACT, MANY OF THE TOXICITIES THAT WERE THOUGHT DUE TO DRUGS, WERE ACTUALLY DUE TO THE PERSISTENCE OF VIRAL REPLICATION. ALSO, THE NOW CLASSICAL HPTNO 2 FILE STUDY SHOWS THAT EARLY INITIATION OF NRT. WHERE ONE IS INFECTED AND THE OTHER IS NOT. IF YOU TREAT EARLY, THE INFECTED PARTNER, THAT WOULD DECREASE THE TRANSMISSION TO THE UNINFECTED PARTNER BY OVER 96%. AND FINALLY, THE QUESTION IS HOW EARLY SUHAIL REALLY START AGENT RETROVIRAL DRUGS AND THIS WAS APPROPRIATELY DONE BY A STUDY CALLED THE START STUDY. TREATMENT WITH ANTI-RETROVIRALS, AT ANY TIME, ESSENTIALLY IMMEDIATELY AFTER YOU KNOW THAT SOMEONE IS INFECTED, REGARDLESS OF WHAT THEIR CD4 COUNT, ACTUALLY REDUCES SERIOUS ILLNESS AND DEATH BY PESSIMISTIC% WHICH REALLY IS TRANSLATED INTO THE FACT THAT RIGHT NOW, THERE'S NO EXCUSE NOT TO PUT EVERY SINGLE PERSON WHO'S H.I.V.-INFECT BOD ANTI-RETROVIRAL DRUGS, WITH VERY FEW EXCEPTIONS. IN FACT, THE WORLD HEALTH ORGANIZATION HAS COME OUT WITH A RECOMMENDATION TO TREAT ALL PEOPLE, LIVING WITH H.I.V. AND TO OFFER ANTI-RETROVIRALS AS AN ADDITIONAL PREVENTION, FOR PEOPLE WHO ARE AT SUBSTANTIAL RISK. ON NOVEMBER 4, I PARTICIPATED IN A DISCUSSION OF THE FAST ATTACK CITIES INITIATIVES, WHICH ACTUALLY WAS A JOINT MEETING OF THE OFFICE OF THE NATIONAL AIDS POLICY OR ONAP AND OAKS BOULEVARD TOGETHER WITH REPRESENTATION FROM UN AIDS AND THE MEETING WAS HELD AT THE WHITE HOUSE. WE DISCUSSED HOW THE FAST TRACK INITIATIVE, NAMELY, FOLLOWING THE NATIONAL STRATEGIC GOALS, AND LOOKING FOR 90% OF PEOPLE WHO ARE INFECTED TO BE DIAGNOSED, 90% ON THERAPY, AND 90% WITH A VIRAL LOAD THAT IS BELOW DETECTABLE LEVEL. THE FAST ATTACKING TO THE END OF AIDS. REALLY IS AS FOLLOWS. WE NEED TO TEST MORE BUT IMPORTANTLY, WE NEED TO PROMPTLY LINK THE CARE OF PREVENTION SERVICES. WE NEED TO OFFER IMMEDIATE ANTI-RETROVIRAL THERAPY FOR ALL H.I.V.-INFECTED INDIVIDUALS, NOT ONLY FOR THEIR OWN HEALTH, BUT TO HELP PREVENT ONGOING TRANSMISSION. AND AS I MENTIONED PREVIOUSLY, PREEXPOSURE P.R.E.P. AND OTHER PREVENTION SERVICES, MUST BE OFFERED TO INDIVIDUALS AT HIGH RESQUE OF INFECTION AND WE BELIEVE THAT IF WE FOLLOW THIS FAST TRACK, WE WILL BE ON THE ROAD TO THE END OF AIDS AS WE KNOW IT NOW. I EMPHASIZE THIS AND THE PRESENTATION I'VE NOW MADE FOR SEVERAL YEARS IN A ROW, AT THE WORLD AIDS DAY EVENT, AT THE WHITE HOUSE. AGAIN, EMPHASIZING THE NEED TO ACT NOW TO BE VERY AGGRESSIVE IN SEEKING OUT, IDENTIFYING, GETTING INTO CARE, ASK TREATING PEOPLE WHO ARE INFECTED, AS WELL AS PROPER PREVENTION MODALITIES FOR THOSE AT RISK. IN FACT, I'VE BEEN EMPHASIZING PUBLICLY FOR SOME TIME, AND ON JULY 10 OF 2016, I WROTE AN OPINION PIECE IN THE "WASHINGTON POST," WHICH WAS ENTITLED NO MORE EXCUSES. WE HAVE THE TOOLS TO END THE H.I.V.-AIDS PANDEMIC. AND I MADE THE "D." WHY DOES THE GLOBAL PANDEMIC CONTINUE TO RAGE. OUR PROVEN TOOLS HAVE NOT BEEN IMPLEMENTED ADEQUATELY OR UNIFORMLY AND I CALL FOR A MORE AGGRESSIVE APPROACH TOWARDS IMPLEMENTATION. LET'S TURN NOW TO OUR ACTIVITY ON MOSQUITO-BORN DISEASES. DXENGI IS A VERY IMPORTANT GLOBAL HEALTH ISSUE, WITH MORE THAN 4 BILLION PEOPLE AT RISK. THERE ARE ABOUT 400 MILLION INFECTIONS, INCLUDING LEADING TO ABOUT HALF A MILLION HOSPITALIZATIONS. MORE THAN A MILLION DALEYS IN 2013, AND WE HAVE NO SPECIFIC TREATMENT, JUST SUPPORTIVE MEDICAL CARE, WHICH IF IMPLEMENTED, COULD ACTUALLY LOWER DEATH RATES FROM 20% TO LESS THAN 1% FOR SEVERE DISEASE. ON THIS MAP IT'S SHOWING THOSE COUNTRIES, WHERE DE IN, GI OUT BREAKS OF COURSE REPORTED. THE NIH ENTERED A XENGI VACCINE TRIAL IN BRAZIL JUST THIS PAST MON. IT'S A PLACEBO CONTROLLED TRIAL IN 13 CITIES. IT'S GOING TO ENROLL ABOUT 15,000 HEALTHY PEOPLE FROM AGE 2-59. IT'S A VACCINE AGAINST THE FOUR TYPES AND IT WAS DEVELOPED BY THE NIAID INTRAMURAL SCIENTISTS. THE TECHNOLOGY WAS LICENSED TO THE NONPROFIT BUTATON NEWT IN BRAZIL, WHICH IS THE SPONSOR OF THE TRIAL. CHICKEN GUNIA, ANOTHER MOSQUITO-BORN DISEASE THAT HAS ENTERED INTO THE WESTERN HEMISPHERE, SHOWN ON THIS SLIDE, IN THE DARK BLUE IS THE GLOBAL DISTRIBUTION OF COUNTRIES AT RISK FOR CHICKEN GUNNIA VIRAL DISEASE. WE SPONSORED A CLINICAL TRIAL OF CHICKEN GUNNIA VACCINE, A PHASE 2 TRIAL OF FOUR HEALTHY ADULTS, AT 6 SITES IN THE CARIBBEAN, IT'S AN EXPERIMENTAL PARTICLE VACCINE, DEVELOPED BY SCIENTIST AT THE NIAID VACCINE RESEARCH CENTER. NOW, IF THAT ACTIVITY WASN'T ENOUGH. AS YOU ALL KNOW BY NOW, WE HAVE HAD A VERY BIG CHALLENGE WITH THE INTRODUCTION OF XIYCA VIRUS INTO THE AMERICANS. A COMMENTARY I WROTE IN THE NEW ENGLAND JOURNAL OF MEDICINE, AS I SAID IN THE TITLE "YET, ANOTHER ASHO VIRUS THREAT, TOGETHER WITH DENGI AND CHICKEN GUNNIA, NOW, WE HAVE XEYCA. FIRST ISOLATED FROM A MONKEY IN 1947, IN THE XYC AFFOREST: THE FIRST KNOWN HUMAN CASE WAS SEVERAL YEARS LATER IN NIGERIA IN 1952, THAT HAS SOME COMMONALITIES WITH WHAT WE KNOW OF OTHER SUCH INFECTIONS, IT'S SPREAD BY PREMOM IFNENTLY, THE E I DIDN'T WANT MOSQUITO. 80% OF INFECTED INDIVIDUALS HAVE NO SYMPTOMS AND THOSE WHO DO, GENERALLY HAVE MILD SISM OF THE MAXIMUMS. THE COUNTRIES WITH EVIDENCE OF XYCA ARE SHOWN ON THIS SLIDE, PRIOR TO 2015. BUT THEN IN MAY 2015. AND WE HAD THE INTRODUCTION PREDOMINANTLY, WITH A MASSIVE OUT BREAK IN BRAZIL, THE NORTH EASTERN SECTION OF THE COUNTRY. IN A VERY DISTURBING EVOLUTIONARY OF CLINICAL INFORMATION, THERE IS CLEARLY A TEMPORAL AND GEOGRAPHIC ASSOCIATION OF INFECTION OF A PREGNANT WOMAN ANYTHING OF THAT NATURE WOMEN AND DEVELOPMENT OF CONGENITAL BIRTH DEFECTS, INCLUDING AND PRENOMENANTLY, MICRO ENSEVERAL YEARSLY, DIRECT TOXICITY TO THE BRAIN. ALTHOUGH THERE'S A TEMPORAL AND GEOGRAPHIC LINKAGE, WE DO NOT KNOW YET WHETHER IT'S CAUSE AND EFFECT WE DO NOT KNOW IF THE XECA IS CAUSING THE PIKE ROW ENSEVERASEVERALENCEPHALY.IN 2010 AND 2014, THERE WAS ABOUT 150 OR SO OF MICRO ENCEPHALY IN BRAZIL. THE FIRST MONTH OF 2016, THERE OF COURSE MORE THAN 4,000 CASES OF MICRO ENCEPHALY IN BRAZIL. BECAUSE OF THIS POSSIBLE LINKAGE BETWEEN INFECTION OF PREGNANT WOMAN, AND THE DEVELOPMENT OF MICRO ENCEPHALY, THE C.D.C. ISSUED TRAVEL -- SLIDE SAYS 14, BUT THERE ARE NOW 22 COUNTRIES AND TERRITORIES, IN CENTRAL AND SOUTH AMERICA AND THE CARIBBEAN AND OUT OF AN ABUNDANCE OF CAUTION, THE ADVISORY IS THAT WOMEN WHO ARE PREGNANT WOMANNENT SHOULD SERIOUSLY CONSIDER POSTPONING TRAVEL TO AREAS WHERE XECA VIRUS TRANSMISSION IS ON GOING. ON NOVEMBER 30, THERE WAS AN NIAID BRAZILIAN [INDISCERNIBLE] ARBO VIRUS CONFERENCE, IN WHICH A WORKING GROUP IS GOING TO DEVELOP A RESEARCH A RESEARCH PLAN FOR XECA. ON DECEMBER 22, THE WRIGHT HOUSE RELEASED THE NATIONAL ACTION PLAN FOR COMBATING MULTIPLE DRUG RESISTANT TUBERCULOSIS, I HAD THE OPPORTUNITY TO MAKE THIS PRESENTATION AT THAT LAMPING, AND THE THREE MAJOR GOALS ARE TO STRENGTHEN DOMESTIC CAPACITY TO COMBAT. TO IMPROVE INTERNATIONAL CAPACITY AND COLLABORATION, AND TO ACCELERATE BASIC AND APPLIED RND. THE TIMELINE IS THAT IMPACT WITHIN THREE TO FIVE YEARS. THERE OF COURSE OTHER THINGS SUCH AS INFLUENZA VACCINE, THAT THE IMPORTANCE DA APPROVED THE FIRST SEASONAL INFLUENZA, WHICH CONTAINED AN ANGIVEN. SOMETHING WE'VE BEEN WAITS FOR, FOR SOME TIME. AND WE HAVE MADE THERAPEUTIC PROFESSIONALS, THAT ARE ALTERNATIVE TO THE TRADITIONAL ANTIBIOTICS. THIS IS PART OF OUR ANTIMICROBIAL RESISTANCE INITIATIVE AND ALSO, THERE'S A PRESEASONAL TREATMENT WITH EITHER AN INHALED CORTICOSTEROID BOOST, TO INCISE DISEXACERBATIONS, IN THE JOURNAL OF CLINICAL IMMUNOLOGY, IT WAS FOUND THAT ADDING [INDISCERNIBLE] TO ONGOING GUIDELINES, AS A THERAPY FOR FOUR MONTHS, STARTING JUST BEFORE THE CHILDREN STARTED TO SCHOOL, ACTUALLY REDUCED BY MORE THAN 50%. THE NUMBER OF ASTHMA ATTACKS IN INNER CITY CHILDREN SO RIGHT NOW, I'D LIKE TO INTRODUCE THE NEXT PART OF THE PROGRAM. DR. PEREZ STABLE, THE DIRECTOR OF NATIONAL INSTITUTE OF MINORITY HEALTH AND HEALTH DISPARITIES WILL PRESENT HIS REPORT TO THE COUNCIL ON THE ACTIVITIES OF NIMHD. THANK YOU MUCH HAVE. >> HELLO, ALESEO PEREZ. FIRST, I WANT TO THANK DR. FOUCHI FOR HAVING INVITED ME TO COME AND PRESENT TO YOU TODAY ABOUT OUR PROGRAMS AT MIMHD. -- NIMHD. FIRST, I WANT TO GIVE YOU A LITTLE SENSE OF THE HISTORY OF OUR INSTITUTE, ESTABLISHED UNDER AN OFFICE UNDER THE NIH DIRECTOR, THROUGH THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNDERSECRETARY SULLIVAN IN 1990. IT WAS TRANSITIONED TO A CENTER THROUGH LEGISLATION, CHAMPIONED BY REPRESENTATIVE LOUIS STOKES IN THE YEAR 2 THOU THOUSAND AND THEN THROUGH THE PATIENT PROTECTION AND AFFORDABLE CARE ACT, CONTAINED LANGUAGE THAT WAS CHAMPIONED BY SENATOR BEN CARDEN TO, TRANSITION TO AN INSTITUTE 2010. SO THE NEWEST INSTITUTE AT NIH AND THEY HAVE ONLY BEEN IN EXISTENCE IN THE PAST 6 YEARS. DR. RUFFIN LED UNTIL HIS RETIREMENT AND DR. YVONNE MADDUX WAS THE ACTING DIRECTOR UNTIL MY ARRIVAL ON SEPTEMBER 1, 2015. WE ALSO BENEFITED FROM THE RECENT INCREASE THAT THE NIH BUDGET SAW, WITH A 3.8% INCREASE, BUT AS YOU NOTE, OUR BUDGET IS $280 MILLION, ALCOHOLS THE SECOND SMALLEST OF ALL THE NEWT--WHICH IS THE SECOND SMALLEST. -- I'LL DWELL ON THE DIFFERENTIAL CRAIG. WE SUPPORT RESEARCH IN MINORITY HEALTH AS DEFIND BY RACIAL EFFECT INCOME GROUPS AND SUPPORT RESEARCH TO UNDERSTAND THE CAUSES OF, THAT LEAD TO REDUCTION OF HEALTH DISPARITIES IN SPECIFIC POPULATIONS. WE'RE ALSO INTERESTED IN TRAINING OF A DIVERSE SCIENTIFIC WORKFORCE, AS PART OF THE BROADER NIH MANDATE. AND THEN TRANSLATINGS AND DISSEMINATING THIS RESEARCH INFORMATION TO THE COMMUNITY, AND FOSTER COLLABORATIONS, BOTH ETERNALLY AND INTERNALLY, WITHIN THE NATIONAL NEWT NATIONAL INSTITUTES OF HEALTH. ONE OF THE GOAL I HAVE FOR CALENDAR '16 IS TO LEAD A BROAD REVIEW OF NIH'S PORTFOLIO, THAT WILL FEED INTO A HEALTH DISPARITIES STRATEGIC PLAN IN 2016. SOMETHING WE ARE, AS AN INSTITUTE, MANDATED TO DO. IN OUR NIMHD STRATEGIC PLAN, WE'LL CASCADE AND BE RELATED TO THE BROADER NIH1. MINORITY HEALTH AND HEALTH DISPARITIES ARE OFTEN TREATED AS NAMES AND CONFUSED WITH THE TERM THAT I'LL CALL "INCLUSION." ALL DIFFERENCES ARE NOT HEALTH DISPARITIES, AND THEREFORE, THE SCIENCE OF MINORITY HEALTH WILL INCLUDE TOPICS WHERE THE OUTCOMES ARE ACTUALLY BETTER FOR THE MINORITY GROUPS. WE DO NEED TO REPORT THESE SEPARATELY IN THE NIH CODING STRUCTURE FOR OUR GRANTS AND OUR INVESTMENTS. ON THE OTHER HAND, INCLUSION OF MINORITIES IN AND OF ITSELF IS NOT MINORITY HEALTH OR HEALTH DISPARITIES. IT IS AN ISSUE OF SOCIAL JUSTICE. COMMON SENSE. THE CLINICAL STUDIES NEED TO HAVE DIVERSE POPULATIONS, DIVERSE SAMPLES THAT REPRESENT WHAT THE AMERICAN DEMOGRAPHICS ARE TODAY. THIS HAS BEEN ESPECIALLY TRUE IN THE TOPIC OF CLINICAL TRIALS FOR PHARMACEUTICAL THERAPEUTICS. OUR INSTITUTE IS EMBARKED ON A STRATEGY TO ADVANCE THE SCIENCE OF HEALTH DISPARITIES. NIMHD HAS, TO SOME EXTENT, NOT HAD THE SAME CREDIBILITY AND ACCEPTANCE OF SCIENTIFIC STANDARDS, AS OTHER INSTITUTES AT NIH. WE FIRMLY BELIEVE THAT THIS IS FOUNDED ON STRONG SCIENCE, AND ONE OF OUR MISSIONS THIS YEAR IS TO EMBARK ON DEFINING THAT. SPECIFICALLY IN MINORITY HEALTH, WE'RE INVESTIGATING THE HEALTH OF RACIAL AND ETHNIC MINORITY GROUPS TO, ASSIGN PROJECTS AND REDUCE HEALTH DISPARITIES AMONG DISADVANTAGED GROUPS AND FIND STRATEGIC PLANE WHERE'STRATEGIC PLANS. MINORITY HEALTH. THIS IS LINKED TO A HISTORICAL SOCIAL DISADVANTAGE AND OR SUBJECT TO DISCRIMINATION AS A COMMON THEME AMONG THESE MINORITY GROUPS. IN ADDITION TO THAT, THESE GROUPS OF COURSE HISTORICALLY UNREPRESENTATIVE, IN BIOMEDICAL RESEARCH AND USUALLY, IN THE SCIENTIFIC WORKFORCE. NOW, THE OFFICE OF MANAGEMENT AND BUDGET STANDARDS FOR THE U.S. CENSUS DEFINES MINORITY RACIAL ETHNIC GROUP AS FOLLOWS: FIRST, AFRICAN-AMERICANS ARE BLACK. SECOND, ASIAN-AMERICANS, WHICH IS A VERY HETEROGENEOUS GROUP WITH OVER 30 COUNTRIES REPRESENTED. AMERICAN INDIAN OR ALASKAAN NATIVE. NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS, FOR EXAMPLE, GUAM, TONGA AND OTHERS, AND THIS PARTICULAR GROUP, PACIFIC ISLANDERS ARE IMPORTANT TO DISTINGUISH FROM ASIAN-AMERICANS, AND THEY ARE FREQUENTLY PUT TOGETHER. AND FINALLY, LATINO OR HISPANIC, WHICH REPRESENT 20 COUNTRIES IN LATIN AMERICA AND CAN BE OF ANY RACE, BEING LATINO DEFINED IS AN ETHNICITY. NOW, DIFFERENCES IN OUTCOMES OR EVENT THAT IS INDICATE A HEALTH DISPARITY IN MY OWN IDEA OF THIS IS COMMON I THINK THIS IS LIKE HIGHER INCIDENTS AND PREVALENCE OR DISEASE MORBIDITY SPECIFIC DIAGNOSE, FOR EXAMPLE, DIABETES IS MOST COMMON AMONG ALL MINORITY GROUPS. POOR SURVIVAL OUTCOMES. MORTALITY. THE BOTTOM LINE, SO TO SPEAK. HIGHER RATES FROM PARTICULAR CAUSES OF DISEASE ARE IMPORTANT. WORSE QUALITY OF LIFE. SELF-REPORTED SYSTEMS OR FUNCTIONS, USING VERY IMPORTANTLY, STANDARDIZED MEASURES. THESE ARE PATIENT PERCEIVED OR POPULATION OR PERSON-PERCEIVED SYMPTOMS AND METRICS. HIGHER OR LOWER RATES OF HEALTH SERVICES EVENTS ACCIDENT SUCHAD HOSPITALIZATIONS, EMERGENCY VISITS. USE OF APPROPRIATE OR INAPPROPRIATE SERVICES. AN IMPORTANT AREA TO INCLUDE. MORE INCIDENT EVENTS THAT DON'T FOLLOW UNDER A SPECIFIC DISEASE DIAGNOSE, FOR EXAMPLE, FALL T. AND DISABILITY ADJUSTED AS A STANDARDIZED METRIC BEING USED WORLDWIDE TO MEASURE POPULATION HEALTH. SO A HEALTH DISPARITY, OPERATIONALLY, IS DEFINED AS A HEALTH DIFFERENCE, THAT ADVERSELY AFFECTS DISADVANTAGED POPULATIONS, BASED ON ONE OR MORE OF THE SIX OUTCOMES THAT I OUTLINED FOR YOU. HEALTH DISPARITIES RESEARCH IS DEVOTED TO ADVANCING SCIENTIFIC KNOWLEDGE, ABOUT THE INFLUENCE OF HEALTH DETERMINANTS, IN DEFINING MECHANISMS IN HOW THIS KNOWLEDGE IS TRANSLATED INTO INTERVENTION, TO REDUCE DISPARITIES. SO UNDERSTANDING CAUSE EFFECT, UNDERSTANDING MECHANISMS, TO BE ABLE TO KNOW, WHERE WE INTERVENE IS REALLY THE MOST IMPORTANT ASPECT OF A HEALTH DISPARITY RESEARCH. SO WHO ARE HEALTH DISPARITY POPULATIONS? WELL, WE START WITH THE OFFICE OF MANAGEMENT BUDGET STANDARDS FOR RACIAL ETHNIC GROUPS, AUTOMATICALLY INCLUDED. WITH LARGE OVERLAP, PERSONS WHO ARE POOR OF LOW INCOME, OF LOWER EDUCATIONAL LEVEL, OF LOW WEALTH OR LOWER SOCIAL CLASS, HOW EVERYONE DEFINES IT ARE ALSO INCLUDED. THESE, IN MY VIEW, ARE THE TWO FUNDAMENTAL PREMISES OF WHAT DEFINES HEALTH DISPARITY IN THE U.S. RURAL GEOGRAPHIC LOCATION IS ALSO INCLUDED IN OUR DEFINITION, BASED ON LEGISLATION. THE AGENCIES FOR HEALTHCARE RESEARCH AND QUALITY OR A.R.Q. HAS BEEN CHARGED WITH COLLABORATE WITHING US, NIMHD IN HELPING DEFINE, WHO IS THE HEALTH DISPARITY POPULATION. WE HAVE NO CURRENT DISAGREEMENT, BUT ARQ DOES LIST A LONG LIST OF PRIORITY POPULATIONS, WHICH I'VE INCLUDED IN THIS SLIDE. AS YOU CAN Z WOMEN, URBAN, POOR, SEXUAL AND GENDER MINORITIES, CHILDREN, ADOLESCENTS, IMMIGRANTS, MI GRANTS, SPECIAL NEEDS, DISABLED, CHRONIC CARE, END OF LIFE, MEDICALLY URN SERVED, DISADVANTAGED, VERY ELDERLY, DOES NOT LEAVE A WHOLE A LOT LEFT. SO ALMOST EVERYONE WOULD BE INCLUDED UNDER THIS DEFINITION. BUT LET ME EMPHASIZE, THESE ARE PRIORITY POPULATIONS THAT DO NOT QUALIFY NECESSARILY AS HEALTH DISPARITY POPULATIONS. AND AS WE ARE CONTINUING OUR DISCUSSIONS ABOUT THIS TOPIC. OUR FUNDAL PREMISES IS GOING TO BE MINORITY, RACE ETHNIC STATUS, IN COMBINATION WITH SOCIOECONOMIC STATUS, REALLY DEFINE THE FUNDAMENTAL PREMISES OF HEALTH DISPARITIES AND THEN OTHER FACTORS WILL COME INTO PLAY, ACCORDINGLY, DEPENDING ON THE CONDITION AND THE POPULATION IN RESEARCH ACTIVITIES, UNDERSTANDING THE IDEOLOGY OF ADVERSE OR HEALTH BENEFICIAL OUTCOMES, ASSOCIATED WITH RACE, ETHNICITY AND SOCIOECONOMIC STANDARDS, NOT EVERYTHING WE SEE IN MINORITY HEALTH IS WORSE OUTCOME. THERE ARE SOME I THINK THIS IS THAT MINORS ACTUALLY DO THINGS BETTER IN. SIMILARLY, BY SOCIOECONOMIC STATUS, NOT EVERYTHING IS WORSE. MOST THINGS ARE. BUT NOT EVERYTHING, AND UNDERSTANDING WHAT LEADS TO THESE DIFFERENT OUTCOMES, I THINK IS A CRITICAL PART OF WHAT WE'RE ABOUT. CLINICAL FACTORS THAT DETERMINE THESE OUTCOME SYSTEM IMPORTANT. AND DEVELOPING AND TESTING INTERVENTIONS TO IMPROVE THE HEALTH STATUS AND REDUCE DISPARITIES, AND ESTABLISHING THIS SCIENCE, IT INCLUDES NOT ONLY METHODOLOGIES, AND MET METRICS AND HOW WE USE TOOLS FROM THE DIFFERENCE SCIENCES. THERE ARE OTHER IMPORTANT ACTIVITIES, SUCH AS TRACKING TRENDS, MONITORING, INCLUSION IN REGISTRIES AND BIOBANKS, AND OF COURSE, INCLUSION IN CLINICAL TRIAL. SO QUESTIONS],EXAMPLES OF QUESTIONS THAT WE'RE INTERESTED N HOW DO DIFFERENCES IN RISK FACTORS, TRANSLATE TO A DISPARITY. WHAT SOCIAL DETERMINANTS INTERACT WITH BEHAVIOR, THAT RESULT IN A HEALTH DISPARITY. WHY DO MORE AGGRESSIVE BY LOGICAL FORMS OF DISEASE EXISTS IN SOME POPULATIONS. HOW AND WHERE DOES ONE ENROLLED SEEN AND WHAT DEFIANCE A BETTER HEALTH OUTCOME WHY DOES THIS HAPPEN. THERE ARE MULTIPLE HEALTH DETERMINANTS AND I'LL SHOW YOU A FRAMEWORK TO LIST THESE. MULTI DISCIPLINARY SYSTEMS APPROACH ACROSS THE LIFE SOMEONE, TO DETERMINE HEALTH DISPARITIES. HEALTH DISPARITY SCIENCE REALLY DOES DEPEND ON SOCIAL BEHAVIORAL POPULATION AND BIOLOGICAL SCIENTISTS AND HOW THE CLINICIAN SCIENTISTS INTEGRATES THIS IN WHAT IS IN THE CARE OF THE POPULATION. MECHANISMS THAT MAY LEAD TO DISPARITIES, EXAMPLES ARE LISTED HERE. EARLIER AGE OF ON SET. WE THINK THAT PROBABLY THAT IS DRIVEN BY BIOLOGY, BUT CAN BE INTERACTED WITH THE ENVIRONMENT. FASTER PROGRESSION OF DISEASE. SIMILARLY, GIVEN BY BIOLOGY, GENETICS OF THE LATER DIAGNOSIS, WHICH IS ALMOST ALWAYS, DUE TO ACCESS BARRIERS FROM THE SYSTEM, ALTHOUGH IT COULD ALSO BE FROM THE INDIVIDUAL. AND DIFFERENT TREATMENT RESULTS, WHICH WE OFTEN DO NOT FULLY UNDERSTAND. MAY BE RELATED TO ADHERENS, MAYBE RELATED TO MEDICATIONS WORK DIFFERENTLY IN DIFFERENT POPULATIONS, BASED ON GENETICS OR BASED ON METABOLISM DIFFERENCES. THIS IS ONE ATTEMPT ON OUR PART, TO CREATE A FRAMEWORK FOR THINKING ABOUT THIS RESEARCH. BIOLOGY BEHAVIOR, AND THE HEALTH CARE SYSTEM, IN DRIVING HEALTH OUTCOMES, IN CREATING OR ELIMINATING DISPARITIES, ALONG THE INDIVIDUAL ACCESS, ALONG THE INTERPERMANENT ACCESS, THE FAMILY, ALONG THE COMMUNITY AND SOCIETY AS A WHOLE. THIS IS SOMETHING THAT IS RELEVANT ACROSS THE LIFE COURSE AND THAT WE'RE PARTICULARLY INTERESTED IN HEALTH OUTCOMES, AS WE OUTLINED BEFORE. MULTIPLE DIFFERENT DIMENSIONS CAN BE INVOLVED HERE. THERE ARE MANY DIFFERENT VARIABLES THAT COULD BE LISTED UNDER THE DIFFERENT CATEGORIES. AND THE IDEA IS THAT IT TAKES A MULTIPLE DISCIPLINES TO APPROACH THIS AND TO EVALUATE WHAT THE OUTCOMES ARE. BECAUSE THIS IS N NIAID, I WANT TO GIVE YOU EXAMPLES OF INFECTIOUS DISEASE WHERE HEALTH DISPARITIES OF COURSE STUDIED OR MINORITY HEALTHY ISSUES HAVE BEEN EMPHASIZED WE ARE FAMILIAR WITH THE HIGHEST RATES OF H.I.V. INFECTION, BEING NOW FOR SOME TIME IN MINORITY MEN, PARTICULARLY BLACK AND LATINO MEN, WHO HAVE SEX WITH OTHER MEN, BUT ALSO IN GENERAL, AND THEY CONTINUE TOFT HIGHEST RATES OF NEW INFECTIONS, SOMETHING THAT WE KNOW IS COMPLETELY PREVENTIBLE. TUBERCULOSIS IS HIGHEST AMONG MINORITIES, PARTICULARLY, AMONG IMMIGRANTS AND HOW DOES RACE OR ETHNICITY INFLUENCE. SUSCEPTIBILITY IS SOMETHING THAT HAS BEEN EVALUATED, AND THERE IS INFORMATION HIGH SUSCEPTIBILITY AMONG AFRICAN-AMERICAN MEN, AND AFRICAN-AMERICANS IN GENERAL. WE KNOW THAT IMMUNOINCOMPETENCE WILL LEAD TO HIGHER RATES OF REACT VISION, THIS IS AN AREA WHERE A ROW MODEL OF A DISEASE, IMPORTANT SOCIAL FACTORS THAT HAS BEEN A GOOD TEMPLATE TO DISCOVERY MINORITY HEALTH. DR. FOUCH. >> Rob: IS NOW ENGAGED ABOUT THE XECA CYRUS, ACCESS TO CARE, IMMUNOIZATION RATES BEING DIFFERENT. ALL OF THESE ARE FACTORS OR TOPICS THAT HAVE BEEN IMPORTANT IN MINORITY HEALTH. LUPUS IS A DISEASE PREMOM DANTELY OF WOMEN. BUT AFRICAN-AMERICAN AND LATINO WOMEN HAVE THE MORE AGGRESSIVE DISEASE. THESE ARE AREAS OF POTENTIAL RESEARCH. NIMHD. 45 OF THEM ARE IN OUR NIH REPORTS. I SHOWED THIS TO YOU JUST FOR EXAMPLE OF SOME OF THE ANALYSIS THAT WE ARE EMBARKING O. THIS IS THE NIH FUNDING AWARDED TO MINORITIES SERVING INSTITUTIONS IN FISCAL YEAR 2015. AS REPORTED TO US BY ALL THE INSTITUTES. NIAID'S TOTAL INTRAMURAL EXTEND TOUR IS LEGALSED, WE DO HAVE A LARGE PROGRAM CALLED THE RCMI PROGRAM, WHICH IS HEAVILY FOCUSED ON THE HISTORICALLY BLACK COLLEGES AND UNIVERSITIES SO WE SEE A BIG DISROPORTIONAL DISPARITIES THERE. THE AMERICAN INTIAN INITIATIVE, INCLUDE -- SUCH AS THE UNIVERSITY OF WASHINGTON AND THESE ARE CATEGORIES THAT ARE DEFIND BY THE DEPARTMENT OF EDUCATION, NOT BY US OR BY NIH. THE HISPANIC SERVING INSTITUTIONS DOES INCLUDE UNIVERSITY OF TEXAS AND SAN ANTONIO. AND ASIAN, AND I SHOW YOU AS ONE OF THE METRICS WE ARE EVALUATING, NOT TO SAY, WHAT IS THE RIGHT PROPORTION. WE SHOULD BE HIGHER SO THAT IS NOT UNEXPECTED. LET ME OUTLINE WHAT MY PRIORITIES ARE. AS I MENTIONED BEFORE, DEFINE THE SCIENCE OF HEALTH DISPARITIES AND TO LEAD THE EFFORTS FOR TRANSNIH STRATEGIC PLAN THIS YEAR. WE WANT TO ALSO PROMOTE INNOVATION FROM EXTRA MURAL SCIENTISTS AND IN HEALTH DISPARITIES, THIS MEANS HAVING A LARGER PORTFOLIO OF RO1-TYPE SCIENCE. I'M INTERESTED IN HAVING US ESTABLISH A HEALTH SERVICES AND CLINICAL RESEARCH IN CLINICAL SETTINGS PROGRAM, FOCUSED ON HEALTH DISPARITIES. IT HAS NOT REALLY HAD A STRONG PRESENCE IN OUR INSTITUTE. AND THE WAY TO FREE FREE UP FUNDING FOR THESE OTHER INITIATIVES, WILL BE TO HAVE FEWER, BUT EQUALLY OUTSTANDING OR EVEN MORE OUTSTANDING CENTERS OF EXCELLENCE, WE CURRENTLY FUND OVER 50. I'M NOT SURE WHAT THE RIGHT NUMBER S BUT IT WILL BE FEWER AND PROBABLY WITH MORE OF A THEME INVOLVED ON A PARTICULAR TOPIC. FINALLY, WE WILL BE CONTINUING TO WORK WITH ALL THE NIH NEWTS, AND THE OFFICE OF THE DIRECTOR THROUGH HANNAH VALENTINE'S OFFICE TO, PROMOTE DIVERSITY IN THE WORKFORCE IN A VARIETY OF PROGRAMS. OUR INTRAMURAL PROGRAM HAS BEEN ESSENTIALLY NONEXIST I WANT. I'M GOING TO CREATE ONE THAT IS FOCUSED ON POPULATION SCIENCE, WITH EMPHASIS WITH A CLINICAL COMPONENT. MY FIRST STEP IS TO RECRUIT SCIENTIFIC DIRECTOR AND SENIOR SCIENTIST, WHO IS AN ACADEMEIOLOGIST, CLINICIAN SCIENTIST, SOCIAL BEHAVIORAL SCIENTIST. WE WILL PROBABLY FUND SOME SORT OF A FLAGSHIP PROJECT AN IMMIGRANT COHORT HAS BEEN DISCUSSED, BUT THIS IS ALL ENDING AND THEN NETWORK WITH OTHER INSTITUTE PROGRAMS, WITH SIMILAR INTERESTS AND WE HAVE ALREADY ESTABLISHED SOME LINKAGE TO NATIONAL INSTITUTE ON AGE, NATIONAL INSTITUTE OF DIABETES AND NATIONAL CANCER INSTITUTE TO NAME A FEWFUL WE LOOK FORWARD TO CONTINUING THAT PROGRAM. I THE TO THANK YOU FOR INVITING ME TO PRESENT TO YOU TODAY, EVEN VIRTUALLY AND I LOOK FORWARD TO ONGOING COLLABORATIONS WITH ALL THE INSTITUTES AT NIH.