>> GOOD MORNING. CAN EVERYONE HEAR ME? VERY GOOD. HELLO AND WELCOME TO THE 19TH ANNUAL AWARDS CEREMONY. IT'S GREAT PLEASURE TO JOIN TOGETHER WITH ALL OF YOU IN ACKNOWLEDGING AND CELEBRATING THE ACCOMPLISHMENTS OF SO MANY FROM OUR CENTER. AND ALSO WE ARE PLEASED OUR COMMISSIONER, MARGARET HAMBERG IS ABLE TO JOIN US TODAY IN THESE CELEBRATIONS. SHE GRACIOUSLY WAS ABLE TO ACCEPT OUR INVITATION IN RECOGNITION OF OUR STAFF AND THEIR ACCOMPLISHMENTS. DR. HAMBERG IS AN ACCOMPLISHED PHYSICIAN AND SCIENTIST AND HAS LONG STANDING COMMITMENT AND DEDICATION TO PUBLIC HEALTH WHICH HAS BEEN TRULY EXEMPLARY. AMONG HER MANY CONTRIBUTIONS, SHE SERVED AS COMMISSIONER OF THE NEW YORK DEPARTMENT OF HEALTH AND MENTAL HYGIENE AND LATER AT THE ASSESSANT SECRETARY FOR POLICY AND EVALUATION IN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. DURING HER TENURE AS COMMISSIONER, SHE'S BEEN OUTSPOKEN CHAMPION OF FDA AS A PUBLIC HEALTH AGENCY AND HAS BEEN INCREDIBLY STRONG ADVOCATE FOR THE ROLE OF REGULATORY SCIENCE AND RESEARCH IN HER WORK. DR. HAMBERG, WE'RE DELIGHTED TO WELCOME YOU TO OUR AWARDS CEREMONY TODAY AND LOOK FORWARD TO YOUR REMARKS. [APPLAUSE] >> THANK YOU SO MUCH KAREN AND THANK YOU FOR ALLOWING ME TO PARTICIPATE IN THIS REALLY EXCITING EVENT. I APOLOGIZE, I CAN'T STAY FOR ALL OF THE AWARDS AND I MUST SAY I DON'T BELIEVE YOU'RE GOING TO GET THEM DOWN IN THE HOUR YOU'VE ALLOTTED BECAUSE THERE ARE AN AWFUL LOT OF THEM. BUT THAT SPEAKS TO THERE'S BEEN AN AWFUL LOT OF REALLY EXEMPT PLAYERY PERFORMANCE AND A LOT OF ACCOMPLISHMENTS THAT WE ALL IN THE FDA FAMILY FEEL VERY PROUD OF BUT THAT ALSO ARE MAKING A HUGE DIFFERENCE IN THE LIVES OF PEOPLE IN THIS COUNTRY AND AROUND THE WORLD THIS IS A LANDMARK YEAR. I KNOW THIS IS YOUR 19TH AWARD CEREMONY FOR CBER BUT IT MARX IMPORTANT ANNIVERSARIES AS WELL IT'S 110TH ANNIVERSARY OF THE BIOLOGIC CONTROL ACT SO THAT'S PRETTY IMPRESSIVE. AND THE 40TH ANNIVERSARY OF CBER INCORPORATION. SO THIS REALLY IS A LAND MARK YEAR. AND IT IS AN IMPORTANT TIME TO RECOGNIZE THE ACCOMPLISHMENTS OF CBER THIS YEAR AND OVER ITS LONG AND DISTINGUISHED HISTORY AND I REALLY WANT TO TAKE A MOMENT TO THANK KAREN FOR HER REALLY EXTRAORDINARY LEADERSHIP, I HAVE REALLY ENJOYED AND BENEFITED FROM THE CHANCE TO WORK CLOSELY WITH KAREN DURING MY TENURE AND I THINK IT'S NO SURPRISE TO ALL OF YOU THAT THE ABILITY OF A PERSON LIKE ME TO DO MY JOB AS COMMISSIONER WELL REALLY DEPENDS ON MY ABILITY TO MITOCHONDRIA ON THE KNOWLEDGE, EXPERIENCE AND EXPERTISE OF THE LEADERSHIP OF THE CENTERS AND ALL OF THE OUTSTANDING PEOPLE WHO WORK HERE. KAREN HAS REALLY, IN HER QUIETLY COMPETENT WAY, BEEN A HUGE ASSET TO ME. IT'S CERTAINLY THE CASE OF KAREN THAT SHE IS A PERSON THAT STEPS UP TO THE PLATE. DOES WHAT NEEDS TO BE DONE. THEY TALK ABOUT NO DRAMA OBAMA. I THINK KAREN, WE HAVE TO THINK OF THE RIGHT LYRICAL PRESENTATION BUT WHAT I LOVE ABOUT WORKING WITH KAREN IS THAT SHE IS THOUGHTFUL, ANALYTIC AND RELIABLE AND SO DEDICATED TO THE CAUSE. SO I REALLY DO APPRECIATE THE CHANCE TO SPEND A LITTLE TIME WITH YOU. I HAVEN'T BEEN WITH CBER IN THIS KIND OF A GROUPING FOR QUITE A WHILE. I WAS REFLECTING THAT SHORTLY AFTER I BECAME COMMISSIONER WHICH IS NOW SOME THREE YEARS AGO, I DID A TOWNHALL AND I WAS SORT OF JUST GETTING TO KNOW FDA AND JUST GETTING TO KNOW HOW IT WORKED IN ITS DIFFERENT COMPONENTS. BUT I DO REMEMBER TALKING ABOUT THE IMPORTANCE OF SCIENCE, AND I THINK THAT MANY OF THE PEOPLE WITHIN CBER I REALLY CAME TO APPRECIATE THAT THERE IS THIS VERY SPECIAL AREA OF SCIENCE, REGULATORY SCIENCE THAT ENABLES US TO HAVE THE KNOWLEDGE AND THE TOOLS TO REALLY NEED TO DO OUR JOB TO EVALUATE THE SAFETY, EFFICACY, QUALITY AND PERFORMANCE OF THE PRODUCTS THAT COME BEFORE US THAT GIVES US THE OPPORTUNITY TO REALLY MODERNIZE OUR APPROACHES IN TERMS OF METHODS AND MODELS AND STANDARDS. AND THE WORK OF CBER HAS REALLY BEEN SO IMPORTANT IN TERMS OF DOING SOME OF THIS VERY VERY IMPORTANT RESEARCH THAT HAS MADE A DIFFERENCE IN THE PRODUCTS THAT HAVE BEEN PRODUCED AND IN THE IMPACT ON PUBLIC HEALTH AND HEALTHCARE. AND I'M ALWAYS PROUD TO BE ABLE TO TALK ABOUT SOME OF THESE ACCOMPLISHMENTS, MOST RECENTLY THE WORK DONE ON THE MENINGITIS VACCINE I THINK REALLY IS AN EXEMPLARY OF HOW OUR FOCUS ON SCIENCE CAN ENABLE A PRODUCT TO BE BETTER AND CAN ENABLE HUGELY IMPORTANT PUBLIC HEALTH BURDENS TO BE LIFTED THROUGH THIS WORK. SO I HOPE ALL OF YOU, IT'S NOT JUST THE SCIENTISTS OF COURSE, THE SCIENTISTS ARE ESSENTIAL BUT IT'S ALL THE PEOPLE THAT SUPPORT THE WORK OF THE SCIENTISTS, THE LAWYERS WHO HELP US NAVIGATE OUR COMPLEX REGULATORY AND LEGAL FRAME WORKS, THE POLICY ANALYSTS, THE ADMINISTRATIVE LEADERSHIP AND THE PEOPLE WHO EVERY DAY HELP SUPPORT US IN OUR JOBS, MAKE SURE WE'RE WHERE WE NEED TO BE AND MAKE SURE THAT THE PLACE ACTUALLY RUNS. SO ALL OF YOU TO REALLY VIEW TODAY AS A CELEBRATION OF YOUR WORK. SOME OF YOU ARE BEING HONORED AS INDIVIDUALS, AS GROUPS, HONORED FOR SPECIFIC INITIATIVES THAT HAVE MADE A DIFFERENCE. BUT EVERYBODY DESERVES RECOGNITION FOR THE WORK THAT YOU DO EVERY DAY. OBVIOUSLY FDA IS A FAMILY, AN UNUSUAL FAMILY BUT THAT'S THINK VERY IMPORTANT FOR US TO RECOGNIZE THAT WE'RE A COMMUNITY. YOU GUYS HAVE BEEN A LITTLE DIFFERENT BECAUSE YOU'VE HAD YOUR HOMESTEAD OUT HERE AT NIH FOR SUCH A LONG TIME. I DO WANT TO JUST RECOGNIZE HOW IMPORTANT I THINK THE MOVIE TO WHITEOUT WILL BE. I KNOW THERE ARE VARIOUS LEVELS OF ENTHUSIASM ABOUT IT AND SOMETIMES, YOU KNOW, THE DEVIL YOU KNOW IS BETTER. BUT THE OPPORTUNITY FOR US ALL TO BE TOGETHER ON THE WHITEOUT CAMPUS, FOR YOU TO HAVE NEW MODERN FACILITIES I THINK WILL BE TERRIFIC BUT THE OPPORTUNITY FOR US TO REALLY WORK TOGETHER TO CROSS FERTILIZE, FOR US TO LOOK FOR NEW WAYS TO COORDINATE AND COLLABORATE AND REALLY REINFORCE THE SENSE OF OUR COMMISSION MISSION I THINK WILL BE VERY EX-- OUR COMMON MISSION I THINK WILL BE EXCITING AND I WANT TO REASSURE YOU WE'LL DO EVERYTHING WE CAN TO SUPPORT YOU. MOVES ARE HARD, WHETHER IT'S A PERSONAL MOVE OR AN INSTITUTIONAL MOVE. ALL TRANSITIONS ARE DIFFICULT. BUT I ENCOURAGE YOU TO LOOK ON THE BRIGHT SIDE AND RECOGNIZE THAT THE WHITEOUT CAMPUS REALLY IS A REMARKABLE PLACE, A REAL SENSE OF ENERGY AND COLLABORATION. AND WE ARE LOOKING FORWARD TO BEING ABLE TO WELCOME ALL OF YOU THERE IN THE COMING YEARS. SO I THINK I'M PROBABLY TALKING TOO LONG BECAUSE WE NEED TO MAKE SURE THAT THERE'S TIME FOR ALL THOSE IMPORTANT AWARDS TO BE GIVEN. I DID WANT TO TAKE A MINUTE OR TWO TO REALLY EXPRESS MY DEEP APPRECIATION THOUGH FOR THE WORK YOU DO AND THE RECOGNITION THAT EACH AND EVERY COMPONENT OF CBER HAS REALLY MADE CONTRIBUTIONS THAT STAND OUT, I MENTIONED THE MENINGITIS VACCINE AND CERTAINLY THE WORK OF THE OFFICE OF BIOSTATISTICS OF EPIDEMIOLOGY, THE WORK OF DATABASES AND FOCUSING ON IMPORTANT QUESTIONS ABOUT SAFETY OF IS A VACCINES IN CHILDREN THAT ARE SO MUCH ON PEOPLE'S MINDS AND OTHER IMPORTANT QUESTIONS THAT AFFECT THE ABILITY TO ACTUALLY DELIVER ON THE PROMISE OF PUBLIC HEALTH. THE OFFICE OF BLOOD RESEARCH AND REVIEW I'VE BEEN SPENDING A LOT OF TIME WITH YOU AS OF LATE. YOU'RE FACING SO MANY CHALLENGING PUBLIC HEALTH ISSUES THAT ARE AT THE INTERFACE OF SCIENCE AND SOCIETY. AND YOU DO SUCH TERRIFIC WORK IN TERMS OF LOOKING AT THE SCIENCE, RECOGNIZING THE CONTEXT IN WHICH THAT SCIENCE NEEDS TO BE ACTED ON AND DEVELOPING POLICIES THAT MAKE SENSE AND MAKE A DIFFERENCE. THE OFFICE OF CELLULAR TISSUE AND GENE THERAPIES HAS RECENTLY APPROVED TWO CORD BLOOD PRODUCTS FOR POTENTIALLY LIFE SAVING STEM CELL TRANSPLANTATION REALLY MARKING IN MANY WAYS THE BEGINNING OF AN IMPORTANT NEW ERA IN HEALTH AND MEDICAL CARE. AGAIN YOU KNOW SUCH CUTTING EDGE SCIENCE, SUCH COMPLEX ISSUES AND OPERATING IN A REALM WHERE THERE'S SO MUCH HOME AND RAISED EXPECTATION BUT WE HAVE AN OBLIGATION TO REALLY ADDRESS THE SCIENCE AND MAKE SURE THAT WE ARE DELIVERING ON THE PROMISE OF THE SCIENCE BUT IN A WAY THAT REALLY SUPPORTS THE KINDS OF HEALTH PROTECTIONS THAT NEED TO BE CONSIDERED AS WELL. THE OFFICE OF COMPLIANCE AND BIOLOGICAL QUALITY WHICH HAS BEEN PROVIDING GLOBAL STANDARDS FOR INFLUENZA VACCINE PRODUCTION HAS BEEN SUCH A CRITICAL PARTNER IN SOME OF OUR GLOBAL HEALTH EFFORTS THROUGH THE WORLD HEALTH ORGANIZATION. THE WORK THAT'S DONE OUT OF THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT IN TERMS OF COMMUNICATING TO THE PUBLIC AND POLICY MAKERS ABOUT THE WORK OF CBER, WHAT YOU DO AND WHY IT MATTERS. YOU KNOW, I COULD GO ON, I'VE ALREADY SAID I THINK I'M TALKING TOO LONG BUT IT'S JUST VERY STRIKING THAT THROUGHOUT THIS CENTER, CUTTING EDGE WORK IS BEING DONE AND WORK THAT IS REALLY MOVING OUR AGENDA AND OUR MISSION TO PROMOTE AND PROTECT THE HEALTH OF THE AMERICAN PEOPLE. SO I ENCOURAGE YOU ALL TO ENJOY THIS CELEBRATION, TO SAVER YOUR REWARDS AND I AM GOING TO GET A REPORT FROM KAREN HOW LONG IT ACTUALLY TOOK. I WISH I COULD STAY TO PARTICIPATE IN THAT BUT MY THOUGHTS WILL BE WITH YOU. CONGRATULATIONS. [APPLAUSE] >> THANK YOU SO MUCH PEGGY, REALLY APPRECIATE IT. ALL RIGHT WELL NEXT WE ARE VERY FORTUNATE ONCE AGAIN TO HAVE JOY JOIN US AND SHE'S GOING TO BE MASTER OF CEREMONIES. I THINK MANY OF YOU KNOW JOY. SHE IS AN ALUMNI OF CBER AND SHE HAS BEEN VERY VERY GRACIOUS TO COME BACK YEAR AFTER YEAR. THIS IS HER THIRD YEAR NOW JOY -- FOURTH. SEE I LOSE TRACK OF TIME. SO JOY COME ON UP AND SHE'S WALK US THROUGH THE AWARDS. THANK YOU SO MUCH. >> THANK YOU KAREN. IT'S GREAT TO BE BACK AGAIN TO PARTICIPATE -- JUST KIDDING. [LAUGHTER] SO IT IS GREAT TO BE BACK, YES. MY NAME IS JOY AND I AM A CBER ALUMN AND CHARTER NUMBER AND IT'S GREAT TO BE GIVING OUT AWARDS AGAIN. MY OFFICIAL DUTY WAS CHAIR OF THE FDA SCIENCE FORM IN DECEMBER OF 97 NOW SO THAT WAS 14 YEARS AGO. SO IT'S GREAT TO BE BACK TO CBER AND THE NIH CAMPUS EVEN IF IT'S JUST FOR A FEW MORE YEARS TO RECOGNIZE THE SUCCESSES OF MY FORMER COLLEAGUES AND RISING STARS. I OFTEN FELT THAT I WORE THE SCARLET B AT THE CENTER AND IT'S SIGNIFICANT THESE DAYS FOR THE RED SOX FANS TO WEAR THE SCARLET B. SO DR. KAREN -- IS GOING TO HOST AND WILL PRESENT THE AWARDS TODAY. OUR AWARDS COORDINATOR IS TAMARA FORD WHO WAS VERY CONCERNED THAT I WOULDN'T GET HERE ON TIME. I TOOK THE BUS. AND HER ASSISTANT ON STAGE IS BRIAN CAMPUS. SO IN THE INTEREST OF TIME THIS AFTERNOON, WE'LL NOT BE READING THE AWARDS CITATIONS. YOU CAN SIMPLY FOLLOW THEM IN YOUR PROGRAM BUT IMPORTANTLY WE WOULD LIKE THE GROUP MEMBERS WHO HAVE BEEN QUITE SHY, PLEASE STAND IF YOU ARE A MEMBER OF THAT GRAM. OUR FIRST AWARD TO BE PRESENTED IS TO THE FDA GROUP RECOGNITION NON-CROSS CUTTING AWE WAR WHICH GOES TO THE FDA HEMOGLOBIN CORE PLANNING TEAM. REPRESENTING THE GROUP IS DR. -- [APPLAUSE] THE SECOND AWARD IS THE DIRECT RECALL CLASSIFICATION EXPANSION TEAM. REPRESENTING THIS GROUP IS LAURA -- [APPLAUSE] THE THIRD APART IS THE MSC RESEARCH CONSORTIUM. REPRESENTING THE GROUP IS DR. STEVEN BOWER. [APPLAUSE] THE FOURTH IS THE E SUBMITTER TEAM. REPRESENTING THE GROUP IS JEFFREY K SMITH. [APPLAUSE] THE FIFTH AWARD IS THE CELL AND GENE THERAPY FOR RETINAL DISORDER, AC PLANNING GROUP AND REPRESENTING THE GROUP IS DR. -- SHE'S NOT HERE. AND THE LAST AWARD IS THE -- THE BLA TEAM AND REPRESENTING THE GROUP IS DR. -- [APPLAUSE] WE'LL ACCEPT THAT FOR HER. OKAY. OUR NEXT CATEGORY IS THE FDA OUTSTANDING SERVICE AWARD. DR. DON -- FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPY. [APPLAUSE] DANA MARTIN FROM THE OFFICE OF COMPLIANCE AND BIOLOGICAL QUALITIES WHO IS UNABLE TO ATTEND TODAY. [LAUGHTER] OKAY. [APPLAUSE] WE'RE JUST TRYING TO MOVE QUICKLY. [LAUGHTER] SALVADOR FROM THE OFFICE OF COMPLIANCE AND BIOLOGICAL QUALITY. [APPLAUSE] DR. RHONDA MELHAM FROM THE OFFICE OF COMPLIANCE AND BIOLOGIC QUALITY WHO WAS UNABLE TO ATTEND SO WE WILL ACCEPT ON HER BEHALF. [APPLAUSE] LILLIAN -- FROM THE OFFICE OF BIOLOGIC QUALITY. [APPLAUSE] JILLIAN CALMLY FROM THE OFFICE OF COMPLIANCE AND BIOLOGIC QUALITY. [APPLAUSE] JANET HARDY FROM THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT. [APPLAUSE] IS THAT ROWDY MANAGEMENT TEAM, I DON'T KNOW. OFFICE OF MANAGEMENT. [LAUGHTER] PATRICIA HARLEY FROM THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT. MAUREEN HESS FROM THE OFFICE OF VACCINES, RESEARCH AND REVIEW. [APPLAUSE] >> DR. SAYER AWE -- FROM THE OFFICE OF VACCINES, RESEARCH AND REVIEW. DR. ELIZABETH -- FROM THE OFFICE OF VACCINES, RESEARCH AND REVIEW. [APPLAUSE] DR. -- DREWS FROM THE OFFICE OF VACCINES, RESEARCH AND REVIEW. [APPLAUSE] DR. LESLIE WHOLENESS FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. DR. JEANETTE -- FROM THE OFFICE OF RESEARCH AND REVIEW, BLOOD RESEARCH AND REVIEW WHO IS UNABLE TO ATTEND TODAY SO WE'LL ACCEPT ON HER BEHALF. KAREN GREENFIELD FROM THE OFFICE OF MANAGEMENT. [CHEERS AND APPLAUSE] NOW OTHER OFFICES, YOU NEED TO STEP IT UP A N DR. BRENTEN FROM CELL TISSUE AND GENE THERAPY WHO IS UNABLE TO ATTEND TODAY SO HE WE WILL ACCEPT ON HIS BEHALF. [APPLAUSE] MARIELLA MERCEDES FROM THE OFFICE OF MANAGEMENT. [APPLAUSE] AND THE LAST AWARD GOES TO THE THERAPEUTIC EVALUATION BRANCH LEADERSHIP GROUP WHICH IS REPRESENTED BY DR. -- [APPLAUSE] THE NEXT AWARD CATEGORY IS THE LEVERAGING COLLABORATION AWARD. THE FDA LEVERAGING COLLABORATION AWARD. THIS GOES TO THE LSIL STEM CELL QCA WORKSHOP THE COMMITTEE REPRESENTING THE GROUP IS JUDITH -- [APPLAUSE] I GOT IT RIGHT. I HAVE TO TELL YOU THAT LAST YEAR OR THE YEAR BEFORE ANYWAY JUDITH ALWAYS GETS THESE AWARDS AND I MANAGED TO MISPRONOUNCE HER NAME THREE DIFFERENT WAYS LAST TIME SO I CALLED HER ON FRIDAY FIRST TO APOLOGIZE AND THEN TO GET THE PRONUNCIATION BUT SHE WASN'T THERE BUT SHE HAD IT ON HER VOICE MAIL SO I GOT IT. [LAUGHTER] THE NEXT AWARD GOES TO THE XMRV SCIENTIFIC RESEARCH WORKING GROUP REPRESENTING THE GROUP IS DR. -- [APPLAUSE] OUR NEXT AWARDEE IS -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. WE WILL ACCEPT ON HER BEHAVIOR. OUR NEXT AWARD CATEGORY IS FDA PLAIN LANGUAGE AWARD WHICH IS AWARDED TO THE OCTGT BURN DEVELOPMENT TEAM. RECOMMENDING THE GROUP IS DR. RACHEL -- [APPLAUSE] OUR NEXT AWARDEE IS DR. MARK KUCINICH FROM THE OFFICE OF DIRECTOR. [APPLAUSE] THE NEXT AWARD CATEGORY IS THE FDA HUMAN CAPITAL INVESTMENT AWARD WHICH IS AWARDED TO DR. MERCY COMPANY -- FROM THE OFFICE OF TISSUE AND CELLULAR GENE THERAPY. [APPLAUSE] OUR NEXT AWARDEE IS JOSEPH -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] LISA -- FROM THE OFFICE OF MANAGE MANY IS UNABLE TO ATTEND HOWEVER -- MERCEDES IS ACCEPTING ON HER BEHALF. [APPLAUSE] THEN WE'LL JUST PHOTOSHOP HER FACE I GUESS. GOOD. OUR NEXT AWARD CATEGORY IS THE CBER SENATE DIRECTOR AWARD FOR THE SENATE DIRECTOR SENIOR AWARD DR. -- FROM THE OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY. [APPLAUSE] DR. -- FROM THE OFFICE OF BIOLOGY AND EPIDEMIOLOGY. [APPLAUSE] DR. -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW IS NOT HERE. OKAY. WE'LL ACT THE CEPT -- ACCEPT ON HIS BEHALF. -- FROM OFFICE OF MANAGEMENT. [CHEERS AND APPLAUSE] JODY -- FROM THE OFFICE OF VACCINE RESEARCH AND REVIEW. OUR NEXT AWARD CATEGORY IS FOR MANAGERIAL EXCELLENCE. DR. MONICA BIRCH FROM THE OFFICE OF THE DIRECTOR. [APPLAUSE] JAY -- FROM THE OFFICE OF COMPLIANCE AND BIOLOGIC QUALITY. DR. STEVEN ANDERSON FROM THE OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY. [APPLAUSE] DR. PAUL RICHMOND FROM THE OFFICE OF VACCINE RESEARCH AND REVIEW. [APPLAUSE] THIS IS SINCE THE LAST TIME I SAW HIM SO IT'S BEEN A WHILE. OUR NEXT AWARDEE IS CONNIE -- FROM THE OFFICE OF MANAGEMENT. DR. LUCIA LEE FROM THE OFFICE OF VACCINES, RESEARCH AND REVIEW. OUR NEXT AWARD CATEGORY IS SUPPORT STAFF EXCELLENCE -- FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPY. GEORGE HOLMES FROM THE OFFICE OF BIOLOGIC QUALITY WHO IS UNABLE TO ATTEND TODAY SO WE'LL ACCEPT ON HIS BEHALF. JACKSON FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] I FEEL LIKE SAYING FELICIA JACKSON COME ON DOWN. THE NEXT AWARD IS THE TECHNICAL EXCELLENCE AND OUR FIRST AWARD IN THIS CATEGORY IS JEFFREY LEARNER FROM THE OFFICE OF COMMUNICATIONS. [CHEERS AND APPLAUSE] DOUGLAS FROM THE OFFICE OF COMPLIANCE AND BIOLOGIC QUALITY. DR. MARY LYNN FROM THE OFFICE OF BIOLOGY AND EPIDEMIOLOGY. [APPLAUSE] FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. SITTING IN THE WRONG CHAIR. GREAT, SHE'S HERE. ELIZABETH -- FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPY. THE LAST AWARD FOR THE SENATOR LEVESQUE DISCLOSURE PROJECTS GROUP. REPRESENTING THIS GROUP IS KATHERINE WILLIS. [APPLAUSE] OUR NEXT AWARD CATEGORY IS FOR ADMINISTRATIVE EXCELLENCE, LINDA DIXON, COME ON DOWN FROM THE OFFICE OF THE DIRECTOR. FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPY. [APPLAUSE] KRISTINE REIGN FROM THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT. [APPLAUSE] THE OBRR BUSINESS WORK GROUP REPRESENTING THE GROUP IS MICHELLE -- [APPLAUSE] THE GROUP OF FDA C REPRESENTING THE GROUP IS DR. -- [APPLAUSE] THE NEXT CATEGORY IS THE SCIENTIFIC ACHIEVEMENT AWARD. THE FIRST SUBCATEGORY IS SENIOR INVESTIGATOR. DR. -- FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPIES HAS WON THIS AWARD WHO IS UNABLE TO ATTEND TODAY SO WE WILL ACCEPT ON HIS BEHALF. [APPLAUSE] THE SECOND SUBCATEGORY IS REGULATORY SCIENTISTS AND OUR FIRST AWARD GOES TO DR. PATRICK -- FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPY. JENNIFER -- FROM THE OFFICE OF BIOLOGIC QUALITY. [APPLAUSE] OUR NEXT AWARDEE IS DR. TIMOTHY FRITZ FROM THE OFFICE OF VACCINES RESEARCH AND REVIEW. [APPLAUSE] AND OUR LAST AWARDEE IN THIS CATEGORY IS DR. STEPHANIE -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. THE THIRD SUBCATEGORY IS STAFF SCIENTIST. OUR FIRST AWARDEE IS DR. -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] DR. -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW IS UNABLE TO ATTEND SO WE WILL ACCEPT ON HIS BEHALF. [APPLAUSE] THE FOURTH SUBCATEGORY IS RESEARCH ASSOCIATES. DR. -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. OUR NEXT AWARD CATEGORY IS THE PUBLIC HEALTH ACHIEVEMENT AWARD. THE FIRST AWARD IS THE CONSTITUENT MATERIALS RULE WORKING GROUP IN AND REPRESENTING THIS GROUP IS DR. STEPHANIE -- [APPLAUSE] THE NEXT AWARD GOES TO THE SMALLPOX VACCINE WORKSHOP PLANNING COMMITTEE AND REPRESENTING THE GROUP IS CYNTHIA KELLY PLAWDZ PLAZA. -- [APPLAUSE] THE NEXT AWARD GOES TO THE -- BLA REVIEW TEAM AND REPRESENTING THE GROUP IS DR. MERCY -- [APPLAUSE] WHO LIKES THE CHALLENGE TO COME ALL THE WAY DOWN THE CHAIR BOTH TIMES. DR. MEGAN -- FROM THE OFFICE OF VACCINE RESEARCH AND REVIEW. [APPLAUSE] EFFICACY SUPPLEMENT REVIEW GROUP AND REPRESENTING THE GROUP IS DR. -- [APPLAUSE] SCORPION ANTI-VENOM GROUP AND REPRESENTING THEM IS DR. -- [APPLAUSE] OUR NEXT AWARD CATEGORY IS FOR POLICY DEVELOPMENT. THE FIRST AWARD GOES TO STEVEN RIPLY FROM THE OFFICE OF THE DIRECTOR. [APPLAUSE] THE NEXT AWARD GOES TO THE THERAPEUTIC CANCER VACCINE GUIDANCE WORKING GROUP AND REPRESENTING THE GROUP IS DR. -- [APPLAUSE] THE NEXT AWARD GOES TO THE QRE WORKSHOP STEERING COMMITTEE AND IS REPRESENTED BY -- [APPLAUSE] OUR NEXT AWARD CATEGORY IS FOR PROGRAM OPERATIONS. THE FIRST AWARD GOES TO THE REVIEW TOOLS GROUP REPRESENTED BY -- [APPLAUSE] WHO IS UNABLE TO ATTEND OR RUN DOWN THE STAIRS. SO WE'LL ACCEPT ON HER BEHALF. THE NEXT AWARDEE IS DR. ALBERT -- FROM THE OFFICE OF THE DIRECTOR. [APPLAUSE] OUR NEXT AWARDEE IS DR. MARK LEE FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPY. [APPLAUSE] OUR NEXT AWARDEE IS EMILY THOMAS FROM THE OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY. OUR NEXT AWARDEE IS FOR THE CBER TWITTER PAGE TEAM AND THAT'S REPRESENTED BY JILL -- WHO IS UNABLE TO ATTEND SO WE WILL ACCEPT THIS AWARD ON HER BEHALF. [APPLAUSE] OUR NEXT AWARDEE IS JEFFREY ANDERSON FROM THE OFFICE OF MANAGEMENT. [CHEERS AND APPLAUSE] THE LAST AWARD IN THIS CATEGORY IS THE DIVISION OF VETERINARY SERVICES REPRESENTED BY DR. JOEL -- [APPLAUSE] A STANDING OVATION FROM THE CROWD. THE NEXT AWARD CATEGORY IS FOR OUTSTANDING REGULATORY RESEARCH PROJECT. THE FIRST AWARD GOES TO THE EID MULTIPLEX ASSAY DEVELOPMENT GROUP REPRESENTED BY DR. -- [APPLAUSE] THE NEXT AWARD GOES TO THE HEMOGLOBIN LEVEL AND INTERDOUGH MODEL INTEGRAL GROUP REPRESENTED BY DR. -- [APPLAUSE] THE NEXT AWARD GOES TO THE PLURAL SEE WORKSHOP COMMITTEE REPRESENTED BY DR. DEBRA HIRSH. [APPLAUSE] THE NEXT AWARD GOES TO -- [APPLAUSE] THE NEXT AWARD IS THE -- MEDICINE PRECEPTORS AWARD REPRESENTED BY -- [APPLAUSE] OUR NEXT AWARD IS TO NANCY WAIT FROM THE OFFICE OF COMPLIANCE AND BIOLOGIC QUALITY WHO IS UNABLE TO ATTEND SO WE WILL ACEPT ON HER BEHALF. [APPLAUSE] OUR NEXT RECIPIENT IS -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] OUR NEXT AWARD CATEGORY IS THE WATER BROWN MEMORIAL AWARD IT IS GIVEN TO THE CBER EMPLOYEE IN SUPPORT POF A SIGNIC POSITION WITH A SUSTAINED PERFORMANCE RELATED TO THE HEALTH COMMUNITY. THE AWARDEE IS FOR THE -- A GENERAL WILLINGNESS TO COOPERATE IN ANY WAY TO SUPPORT CBER RESEARCH ACTIVITIES, THE RECIPIENT SHOULD REPRESENT THE HIGH PRINCIPLES AND STANDARDS OF ETHICS EXFIDE BY MR. BROWN AND THE AWARD GOES TO -- [APPLAUSE] OUR NEXT AWARD CAT GREASE THE HOPE HOPS MEMORIAL AWARD PRESENTED TO A CBER EMPLOYEE IN A PROFESSIONAL POSITION WHOSE DISPLAY OF EXCEPTIONAL LEADERSHIP OR SCIENTIFIC ACHIEVEMENT UPHOLDS THE MISSION OF THE CENTER WHILE MAINTAINING THE HIGH IDEALS GOALS AND STANDARDS OF PERFORMANCE EXEMPLIFIED BY MS. HOPS FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] ON IS FIRST AWARD GOES TO THE BUDGET FUNCTIONS OF MEDICAL COUNTERMEASURES INITIATIVES. REPRESENTED BY THIS GROUP IS DR. CAROLYN WILSON. [APPLAUSE] CAROLYN, I THINK YOU WIN IT FOR THE FASTEST, YOU KNOW, COMING DOWN THE AISLES TO WIN THE AWARD. OUR NEXT AWARD GOES TO THE TECHNOLOGY TRANSFER TEAM REPRESENTED BY DR. MOHAMED -- [APPLAUSE] THE NEXT AWARD GOES TO THE SAFETY OF THE -- VACCINE REPRESENTED BY DR. ROBERT -- [APPLAUSE] THE NEXT AWARD GOES TO THE INTERBRANCH EDUCATIONAL SEMINAR SERIES REPRESENTED BY DR. -- [APPLAUSE] CONTRACTOR OFFICER REPRESENTATIVE SEMINAR SERIES WORKING GROUP REPRESENTED BY DR. -- BISHOP. [APPLAUSE] THE ADENO VIRUS LICENSURE TEAM REPRESENTED BY DR. -- MILLER. [APPLAUSE] THE ABBOTT -- SUPPLEMENTAL ASSAY GROUP REPRESENTED BY DR. ALAIN -- [APPLAUSE] THE DIVISION OF HEMATOLOGY, PHARMACOLOGY AND TOXICOLOGY TEAM REPRESENTED BY DR. -- [APPLAUSE] THE CBER ITR PROCESS WORKING GROUP REPRESENTED BY -- [CHEERS AND APPLAUSE] THE STRUCTURED PRODUCT LABELING INDEXING DATA ELEMENTS WORKING GROUP REPRESENTED BY DR. -- [APPLAUSE] I DON'T KNOW IT'S ALMOST AS ROWDY AS THE ENTIRE OFFICE OF MANAGEMENT. THE CBER WHO COOPERATIVE AGREEMENT WORKING GROUP TEAM REPRESENTED BY DR. -- [CHEERS AND APPLAUSE] THE TRACTION IMPLEMENTATION TEAM REPRESENTED BY CAROL -- [APPLAUSE] WHO IS ALSO NOT AVAILABLE TO RECEIVE THIS AWARD SO WE WILL RECEIVE ON HER BEHALF. OUR LAST AWARDS CATEGORY BEFORE CAREER RECOGNITION, WE WOULD LIKE TO RECOGNIZE THOSE EMPLOYS WHO HAVE COMPLETED OR 20 OR 30 LONG YEARS OF SERVICE. [LAUGHTER] SO OUR 30 YEARS OF CAREER SERVICE RECOGNITION WHICH SEEMS LIKE YESTERDAY AWARDS ARE DR. KRISTINE -- FROM THE OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY. [APPLAUSE] DANIEL KEARNS FROM THE OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY. NOT HERE. DR. JAY EPSTEIN FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [CHEERS AND APPLAUSE] I DON'T KNOW. MAY HAVE BEEN THE LOUDEST. SPEECH SPEECH SPEECH. [APPLAUSE] JAY, I CAN'T BELIEVE YOU'RE NOT GOING TO SAY ANYTHING. [LAUGHTER] SO UNCHARACTERISTIC. DR. EL ROSS PIERCE FROM THE OFFICE OF RESEARCH AND VERY VIEW WHO IS NOT HERE. SYLVIA GAY FROM THE OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY. NOT HERE. MICHAEL FONT LEEROY FROM THE OFFICE OF THE DIRECTOR. AND WE HAVE SOME THAT ACTUALLY WERE UNABLE TO ATTEND AND TOLD US THEY WERE UNABLE TO ATTEND. ANTHONY HAWKINS FROM THE OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY FOR 30 YEARS. MARY PADGETT FROM THE OFFICE OFFICE DIRECTOR. DR. SUSAN EPSTEIN FROM THE OFFICE OF CELLULAR TISSUE AND GENE THERAPY. GAYLE -- FROM THE OFFICE OF VACCINES, RESEARCH AND REVIEW. -- JACKSON FROM THE OFFICE OF MANAGEMENT. AND MARY ANN GALLAGHER FROM THE OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY. [APPLAUSE] AND NOW WE HAVE THE CATEGORY FOR 20 YEARS OF CAREER OF BLISSFUL CBER SERVICE. PATRICIA HARLEY FROM THE OFFICE OF COMMUNICATIONS, OUTREACH AND DEVELOPMENT. [APPLAUSE] DR. MARK -- FROM THE OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY. [APPLAUSE] DR. -- WONG FROM THE OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY. [APPLAUSE] FELICIA JACKSON FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] DR. AMELIA HORN FROM THE OFFICE OF BIO STATISTICS AND EPIDEMIOLOGY. [APPLAUSE] SUSAN -- FROM THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT. [CHEERS AND APPLAUSE] JOSEPH -- THE THIRD FROM THE OFFICE OF BIOLOGICS AND OFFICE QUALITY. [APPLAUSE] DR. DEBRA VOSS FROM THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT. [APPLAUSE] NO DOCTOR, SORRY. MAYBE WE'LL GIVE YOU AN HONORARY RIGHT HERE. YOU DO THAT, DON'T YOU, AT AWARDS. NO DOCTOR DOUGLAS -- FROM THE OFFICE OF MANAGEMENT. [CHEERS AND APPLAUSE] NOT HERE. NOT HERE. MARY ANN MOYER FROM THE OFFICE OF DIRECTOR. [CHEERS AND APPLAUSE] GERALDO KAPLAN FROM THE OFFICE OF -- REVIEW [APPLAUSE] GIVE ME A SHOW OF HANDS WHO IS GOING TO STAY FOR THE 30 YEAR AWARD. [APPLAUSE] DR. LESLIE -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] SONDRA -- FROM THE OFFICE OF BLOOD RESEARCH AND REVIEW. [APPLAUSE] AND THE FOLLOWING EMPLOYEES ARE UNABLE TO ATTEND -- SELL FROM THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT. ROBERT FISHER FROM THE OFFICE OF VACCINE RESEARCH AND REVIEW. [APPLAUSE] TREE -- FROM THE OFFICE OF COMMUNICATIONS OUTREACH AND DEVELOPMENT. -- FROM THE OFFICE BLOOD RESEARCH AND REVIEW. PIGGY NOLEN FROM THE OFFICE OF BY LODGICS AND OFFICE -- PEGGY NOLEN FROM THE OFFICE OF BIOLOGICS AND OFFICE QUALITY. JIM -- FROM THE OFFICE OF THE DIRECTOR. HELEN -- FROM THE OFFICE OF VACCINE RESEARCH AND REVIEW. [APPLAUSE] JEFFREY MAC WIRE FROM THE OFFICE OF BIOLOGIC AND OFFICE QUALITY. [APPLAUSE] GAYLE -- FROM THE OFFICE OF MANAGEMENT. [APPLAUSE] -- LYNN FROM THE OFFICE OF VACCINE RESEARCH AND REVIEW. [APPLAUSE] -- FROM THE OFFICE OF COMPLIANCE AND BIOLOGIC QUALITY. [APPLAUSE] HENRY SOO FROM THE OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY. [APPLAUSE] JENNIFER BRIDGEWATER FROM THE OFFICE OF VACCINE RESEARCH AND REVIEW. [APPLAUSE] -- FROM THE OFFICE OF COMPLIANCE AND BIOLOGIC QUALITY. [APPLAUSE] -- FROM THE OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY. [APPLAUSE] SO HOW ABOUT A ROUND OF APPLAUSE FOR ALL OF TODAY'S AWARD RECIPIENTS. [CHEERS AND APPLAUSE] AND DR. -- WILL NOW ADDRESS TODAY'S AUDIENCE WITH CLOSING REMARKS. BUT I MIGHT ADD IF DR. HAMBERG HAD NOT LASTED SO LONG WE WOULDN'T HAVE MADE IT TO THE 2:00. [APPLAUSE] >> JOY, THANK YOU FOR DOING AN WONDERFUL JOB OF MC-ING OUR FESTIVITIES ONCE AGAIN. I WANT TO THANK ALL OF YOU FOR THE INCREDIBLE WORK YOU'VE DONE OVER THE PAST YEAR. NOT ONLY THAT THE WORK YOU DO EVERY YEAR, YEAR IN YEAR OUT I THINK IT REALLY MAKES US A VERY STRONG FAMILY A COMMUNITY AND WE GO THROUGH THE GOOD TIMES, WE CELEBRATE THOSE AND WE STICK TOGETHER IN THE TOUGH TIMES AND GET THROUGH THOSE AL SO. I THINK WE'VE GOT A LOT TO BE REALLY PROUD OF, A LOT OF REALLY WONDERFUL ACCOMPLISHMENTS THIS PAST YEAR. I THINK THAT DR. HAMBERG TOUCHED ON A NUMBER OF THEM. WONDERFUL APPLICATIONS THAT WE'VE APPROVED, EXCELLENT ADVISORY COMMITTEES THAT WE'VE GOTTEN THROUGH EITHER THAT HELPED US SET THE PRODUCT APPROVAL OR HELPED US DEVELOPED LICENSURE PATHWAYS TOWARDS APPROVAL OR HELPED US WITH SOME DIFFICULT ISSUES WE WERE GRAPPLING WITH. I THINK THAT ACCOMPLISHMENTS BOTH IN THE REVIEW IS IN THE INITIAL RELATED RESEE OF RELIEF EXEMPLARY. I KNOW WE HAVE A LAW OF CHALLENGES AHEAD OF US WHETHER IT'S WITH DIFFICULT PRODUCTS OF ASPECTS OR GETTING READY FOR THE NEW BUT WHAT I WANT TO SAY I THANK YOU FOR THE SUPPORT YOU DID AND THE HELP YOU HELPED US NAVIGATE THROUGH THOSE GOOD TIMES AND BAD AND IT'S WONDERFUL TO BE ABLE TO CELEBRATE THE ACCOMPLISHMENTS OF THE STANDARDS AS A WHOLE. SO THANK YOU SO MUCH AND I WELCOME YOU TO JOIN IN A LITTLE BIT OF REFRESHMENTS. I UNDERSTAND THAT WE'RE STILL ALLOWED TO HAVE THOSE AS PART OF OUR AWARDS CEREMONY. SO THANK YOU SO MUCH AND PLEASE GO AND ENJOY. THANK YOU.