>>> GOOD MORNING AND WELCOME BACK. GOOD RESPONSE. I HOPE YOU HAD A RELAXING EVENING AND READY AND REFRESHED TO RESEARCH THESE THERAPIES. WE HAD GREAT COVERAGE IN STAT NEWS THIS MORNING. I DON'T KNOW IF ANYONE GOT THAT E-MAIL. HEADLINES BEGIN WITH COAL MINING AND THEN SAFETY AND THEN CLOSING A RESEARCH GAP. SO WE ARE AFTER SAFETY BUT STILL MADE THE HEADLINE. AND THE TOPIC TITLE IS, EXPERTS TACKLE THE GAP IN RESEARCH ON PREGNANT WOMEN. SO THAT'S PRETTY EXCITING. I'M ALSO DELIGHTED TO LET YOU KNOW I RECEIVED A NUMBER OF E-MAILS LAST NIGHT FROM PEOPLE ATTENDING VIRTUALLY. SO WELCOME TO OUR VIRTUAL AUDIENCE. THEY SAY THAT IT IS EASY TO UNDERSTAND, EASY TO FOLLOW, SO THAT IS WONDERFUL AS WELL SO, KEEP THAT COMING. WE ARE DELIGHTED TO HAVE ALL THE PARTICIPANTS IN THE ROOM AND VIRTUALLY. IN THE INTEREST OF OBTAINING AS MANY PERSPECTIVES AS WE CAN, WE ARE HOLDING PANEL PRESENTATIONS WITH OPEN DISCUSSION TO HEAR AND THEN ALSO TODAY WE WILL HEAR FROM INDIVIDUAL WHOSE FILED PUBLIC COMMENTS. WE'LL HAVE A TIME FOR PUBLIC COMMENTARY AS WELL. OUR FIRST PANEL WILL FOCUS ON A COMPONENT OF THE CONGRESSIONAL MANDATE TO HELP THE TASK FORCE DEVELOP RECOMMENDATIONS FOR COORDINATION AND COLLABORATION ON RESEARCH. WE'LL BEGIN WITH THREE BRIEF PRESENTATIONS FOLLOWED BY A PANEL DISCUSSION. THERE WILL BE TIME AT THE END FOR QUESTIONS AND COMMENTS. DR. BIANCHI WILL LEAD OFF WITH OVERVIEW OF NIH'S EFFORTS FOLLOWED BY DR. JENKINS PROVIDING FDA PERSPECTIVE AND THEN DR. CHRISTINA BUCCI-RECHTWEG WITH SOME THOUGHTS ON INDUSTRIES POINT OF VIEW AND DR. BIANCHI, WE ASK YOU TO GET US STARTED. >> DR. BIANCHI: GOOD MORNING, EVERYBODY. IT'S GREAT TO BE HERE TODAY AFTER SUCH A WONDERFUL DISCUSSION YESTERDAY. I'M GOING TO SUMMARIZE SOME OF THE COLLABORATIONS AGAIN. YESTERDAY THERE WERE COMMENTS ABOUT THINGS WE LEFT OUT IN THE INTEREST OF TIME. I'M ONLY GOING TO BE GIVING EXAMPLES. I ALWAYS FORGET IT'S THE LEFT SIDE. COUNTERINTUITIVE. SO SOME OF YOU WERE NOT HERE YESTERDAY SO IT'S GOOD WE HAVE A CHANCE TO REPEAT SOME OF THIS. BUT THE CURRENT COLLABORATIONS FOR NIH INCLUDE COMMITTEES. WE COLLABORATE WITHIN COMMITTEES, ADVISORY GROUPS, WORKING GROUPS, WE'LL BE GOING INTO SOME OF THESE IN DETAIL IN THE FOLLOWING SLIDES, MEETINGS, CONFERENCES AND WORKSHOPS, HEALTH SURVEYS, RESEARCH INITIATIVES AND RESOURCE DEVELOPMENT AND PUBLIC EDUCATION CAMPAIGNS. AND IF YOU LOOK AT THE FINE PRINT AT THE BOTTOM OF THE SLIDE, IT SAYS THAT NIH TRACKS COLLABORATIONS WITH OTHER HHS AGENCIES AND PROVIDES THIS INFORMATION IN A REPORT AND DATABASE. THAT'S HOW I COULD GIVE YOU THE NUMBERS YESTERDAY OF HOW MANY TIMES OUR STAFF COLLABORATED WITH OTHERS. SO AGAIN, JUST EXAMPLES, NOT COMPREHENSIVE. SOME EXAMPLES OF ONGOING COMMITTEES AND WORKING GROUPS, FOR EXAMPLE, BREASTFEEDING AND HUMAN LACTATION RESEARCH SCIENTIFIC INTEREST GROUP, NIH, FDA AND OSG, COLLABORATE ON THIS. THE ADVISORY COMMITTEE FOR IMMUNIZATION PRACTICES, ACIP, THE CDC AND FDA COLLABORATE WITH NIH. THE FEDERAL SUDDEN INFANT UNEXPLAINED INFANT DEATH, SIDS WORK GROUP, INCLUDES MANY PARTNERS IN TERMS OF MEETINGS AND WORKSHOPS, AS MOST OF YOU KNOW, WHEN WE PLAN A WORKSHOP, THE GOAL IS TO BRING TOGETHER RESEARCHERS, FEDERAL AGENCIES, INTERNATIONAL PARTNERS, PROFESSIONAL SOCIETIES AND HEALTH CARE PROFESSIONALS TO OUTLINE CURRENT RESEARCH GAPS AND DEVELOP A RESEARCH PLAN TO ANSWER IMPORTANT PUBLIC HEALTH ISSUES. SO, THOSE RESEARCH GAPS ARE THEN USUALLY TRANSLATESSED INTO REQUESTS FOR GRANT APPLICATIONS. SOME RECENT EXAMPLES YESTERDAY I MENTIONED THE OPIOID USE IN PREGNANCYNY NATAL ABSENCE SYNDROME, CALLED NEONATAL OPIOID WITHDRAWAL SYNDROME, AND CHILDHOOD OUTCOMES. AND ANOTHER EXAMPLE IS BRINGING KNOWLEDGE GAPS TO UNDERSTAND HOW ZIKA VIRUS EXPOSURE AND INFECTION EFFECTS CHILD DEVELOPMENT AND NIH AND CDC WORK TOGETHER ON THAT. WITH THE HEALTH SURVEYS, THEY ARE USED TO ESTABLISH AN INFORMATION BASE. THERE IS THE AMERICAN COMMUNITY SURVEY, ACS, WHICH IS A COLLABORATION BETWEEN THE U.S. CENSUS BUREAU, THE CDC AND NIH. THIS PROVIDES VITAL INFORMATION ON A YEARLY BASIS ABOUT OUR NATION AND ITS PEOPLE. AND IT GENERATES DATA THAT HELP TO DETERMINE HOW MORE THAN 400 BILLION DOLLARS IN FEDERAL AND STATE FUNDS ARE DISTRIBUTED EACH YEAR. THE NATIONAL SURVEY OF FAMILY GROWTH. WE HEARD ABOUT THIS YESTERDAY IN THE CDC PRESENTATION. IT'S A COLLABORATION BETWEEN CDC AND NIH. THIS GATHERS INFORMATION ON FAMILY LIFE, MARRIAGE AND DIVORCE, PREGNANCY, INFERTILITY, THE USE OF CONTRACEPTION AND MEN AND WOMEN'S HEALTH. THE RESULTS ARE USED BY HHS AND OTHERS TO PLAN HEALTH SERVICES EDUCATION PROGRAMS AND TO CONDUCT STATISTICAL STUDIES OF FAMILY FERTILITY AND HEALTH. HERE IS MORE EXAMPLES OF RESEARCH COLLABORATIONS AND RESOURCE DEVELOPMENT. WE HAVE THE ANTI--RETROVIRAL PREGNANCY REGISTRY, A COLLABORATION BETWEEN CDC, FDA -- I FEEL LIKE WE SHOULD HAVE HAD ALPHABET SOUP FOR BREAKFAST. HRSA AND NIH. MAYBE LIKE -- WHAT WERE THE CEREALS WITH THE LETTERS IN THEM? FEDERAL INTERAGENCY FORUM ON CHILD AND FAMILY STATISTICS, CDC, HRSA, SAMHSA, NIH AND AHRQ. THE ZIKA EXPERIMENTAL SCIENCE TEAM OR ZEST DATA PORTAL IS A COLLABORATION AMONG FDA, HRSA AND NIH. AND THE USPSTF A COLLABORATION BETWEEN AHRQ, CDC, NIH, OASH, SAMHSA AND OTHERS. ED AND PREG SOURCE, WHICH I'LL GO INTO DETAIL ON THE NEXT SLIDE, IS A COLLABORATION BETWEEN NIH, CDC AND HRSA. AND PREG SOURCE ALSO HAS MULTIPLE PROFESSIONAL SOCIETY PARTNERS. YOU CAN SEE MANY OF THEM HERE, SMFM FOR EXAMPLE WHO IS HERE AT THIS MEETING, GENETIC ALLIANCE, OTHER NIH INSTITUTES, ET CETERA. AND PREG SOURCE IS USED BOTH AS OR WILL BE USED AS A RESOURCE AND A CROWD FUNDING OPPORTUNITY FOR RESEARCH. AND HERE IS HOW IS IT INTENDED TO WORK. EACH PARTICIPANT LOGS IN PERIODICALLY OVER THE COURSE OF HER PREGNANCY AND AFTERWARDS. SHE WILL RECEIVE MONTHLY GESTATIONAL-AGE AND POST-PREGNANCY QUESTIONNAIRES INCLUDING QUESTIONS ABOUT HER BABY'S DEVELOPMENT. SHE WILL ENTER DATA IN ON LINE TRACKERS AS OFTEN AS DAILY. AND SOME WOMEN BASED ON HER INITIAL RESPONSE WILL RECEIVE SPECIALIZED QUESTIONNAIRES TARGETED TO HER SPECIFIC CONDITIONS. SO FOR EXAMPLE, IF SHE RESPONDS F SHE HAS DIABETES OR PHYSICAL DISABILITIES, SHE WILL GET ADDITIONAL QUESTIONNAIRES. AND THEN WOMEN WILL ALSO PROVIDE INFORMATION ABOUT COMMON PREGNANCY EXPERIENCES IN NEAR REAL-TIME ABOUT SLEEP, QUALITY OF HER SLEEP, WHETHER OR NOT SHE HAS NAUSEA, HOW OFTEN SHE IS EXERCISING, AND HOW HER WEIGHT IS CHANGING OVER THE TERM OF THE PREGNANCY. AND THE ANSWERS TO THESE TOPICS WILL HELP RESEARCHERS BUILD A MORE COMPLETE PICTURE OF NORMAL PREGNANCY AND DEVELOP STRATEGIES FOR IMPROVING MATERNAL CARE. THERE IS ALREADY ANOTHER CROWD SOURCING SITE AT SCRIPPS AND JENNIFER IS HERE IN THE AUDIENCE. I BELIEVE SHE WILL MAKE COMMENTS DURING THE PUBLIC PERIOD. SOME EXAMPLES. RECENT COLLABORATIONS USING NICHD RESEARCH NETWORK INFRASTRUCTURE INCLUDE THE OBSTETRIC FETAL PHARMACOLOGY RESEARCH NETWORK IN COLLABORATION WITH THE FDA, FMU, WHICH IS A COLLABORATION WITH NHLBI, NINDS AND THE FDA. THE NEW MOMS TO BE STUDY WHICH IS A COLLABORATION WITH NHLBI, THE NEONATAL RESEARCH NETWORK WHICH ALSO COLLABORATES WITH THE CDC, FDA AND THE NHLB I AND GLOBAL NETWORK FOR WOMEN AND CHILDREN'S HEALTH RESEARCH, A COLLABORATION WITH USAID. WITH THE PUBLIC EDUCATION CAMPAIGNS I MENTIONED YESTERDAY, WE HEARD TEXT FOR BABIES MENTIONED SEVERAL TIME. I'M NOT GOING TO READ THROUGH ALL OF THESE DIFFERENT ORGANIZATIONS. BUT I THINK WE COULD CERTAINLY MENTION THAT IN THE PANEL TO TALK ABOUT HOW THIS MOBILE TECHNOLOGY COULD BE USED BOTH FOR RESEARCH AND TO EDUCATE THE PUBLIC. NATIONAL CHILD AND MATERNAL HEALTH EDUCATION PROGRAM AGAIN, MANY, MANY ORGANIZATIONS INVOLVED WITH THIS. AND THE SAFE TO SLEEP CAMPAIGN, AGAIN, MULTIPLE, MULTIPLE ORGANIZATIONS AS WELL AS TREATING FOR TWO WHICH CAME UP YESTERDAY. SO, WE WANTED TO PUT OUT SOME ADDITIONAL POTENTIAL OPPORTUNITIES FOR NEW COLLABORATIONS. THERE IS SOMETHING CALLED THE G CAPER, THE GLOBAL COALITION TO ADVANCE PRETERM BERTH RESEARCH. THAT IS A COLLABORATION BETWEEN THE MARCH OF DIMES, THE GATES FOUNDATION, NICH. AND MULTIPLE OTHER FOUNDATIONS INCLUDING 20 ORGANIZATION INVOLVED, WITH THE GOAL BEING TO REDUCE PRE-TERM BIRTH AND IMPROVE MATERNAL AND NEWBORN HEALTH THROUGH EXPANDED SCIENTIFIC KNOWLEDGE COMMUNICATIONS AND COLLABORATIONS. YOU HEARD YESTERDAY A LITTLE BIT ABOUT THE HUMAN PLACENTA PROJECT, WHICH HAS A GOAL, FUNDED BY NICHD, TO UNDERSTAND HUMAN PLACENTAL DEVELOPMENT, STRUCTURE AND FUNCTION IN REALTIME AND I DO BELIEVE THAT THERE ARE CERTAIN ASPECTS OF THE FUND RESEARCH THAT ARE VERY RELEVANT TO WHAT WE ARE DISCUSSING HERE WITHIN THE TASK FORCE. AND THEN JUST AS A REMINDER, THERE ARE ADDITIONAL OPPORTUNITIES TO COLLABORATE WITH THE VARIOUS NIH RELATED PREGNANCY RESEARCH NETWORKS THAT IS MY BRIEF PRESENTATION. WE'LL GO ON TO THE NEXT ONE. THANK YOU. [ APPLAUSE ] >> DR. JENKINS: THANK YOU. GOOD MORNING. I WANT TO THANK DR. BIANCHI FOR GOING OVER THOSE GREAT COLLABORATIONS. DR. CHRISTINA BUCCI-RECHTWEG AND DR. BIANCHI AND I MET AND DISCUSSED OUR CONTENT SO IT WAS VERY HELPFUL SO WE COULD MAXIMIZE OUR PRESENTATIONS FOR YOU. AS MENTIONED YESTERDAY, THE FDA COLLABORATES INTERNALLY AND EXTERNALLY ACROSS MANY PROGRAMS AND ORGANIZATIONS TO BENEFIT WOMEN, PREGNANT WOMEN AND LACTATING WOMEN. I WANTED TO START FIRST WITH REGULATORY SCIENCE. FDA PERFORMANCE RESEARCH IN SUPPORT OF REGULATORY SCIENCE AND IT IS THE FOUNDATION OF WHAT WE DO. IT'S THE SCIENCE OF DEVELOPING NEW TOOLS, STANDARDS AND APPROACHES TO ASSESS THE SAFETY, EFFICACY AND QUALITY AND PERFORMANCE OF FDA REGULATED PRODUCTS. AND YOU CAN SEE HERE STRATEGIC PLAN IN ADVANCING REGULATORY SCIENCE THAT IS AVAILABLE ON LINE. YESTERDAY WE MENTIONED THAT THE MAJOR PLAYERS AT THE FDA IN RESEARCH FOR PREGNANT WOMEN AND LACTATING WOMEN ARE OUR PRODUCT CENTERS. AND OUR NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH AS WELL AS THE OFFICE OF WOMEN'S HEALTH. I WANTED TO SPEAK ABOUT THE WORK OF THE OFFICE OF WOMEN'S HEALTH. WE REPRESENT A -- WE SIT AT THE OFFICE OF THE COMMISSIONER LEVEL SO WE WORK ACROSS THE AGENCY. WE COLLABORATE WITH ALL THE PRODUCT CENTERS. WE CREATED, WITH THE INPUT OF ALL OF THE CENTERS AND LEADERSHIP AT THE AGENCY, WE PUBLISHED THE FIRST WOMEN'S HEALTH RESEARCH ROADMAP IN 2016. AND IF YOU LOOK AT THE 7 PRIORITY AREAS, THINGS LIKE ADVANCING SAFETY AND EFFICACY OF PRODUCTS, EMERGING TECHNOLOGIES, BIOMARKERS, HEALTH COMMUNICATIONS, YOU'LL SEE PREGNANCY AND LACTATION MENTIONED THROUGHOUT THE ROADMAP. OUR INTRAMURAL GRANT FUNDING PROGRAM HAS BEEN IN PLACE SINCE 1994 AND I JUST PULLED A SELECTIVE NUMBER THAT HAD BEEN FUNDED OVER THE PAST FIVE YEARS. YOU CAN SEE THAT WE FUNDED ACROSS ALL OF THE CENTERS IN VARIOUS WAYS. SOME PUBLIC AND PRIVATE COLLABORATIONS AND ALSO INNER AGENCY COLLABORATIONS INTERNAL EXPOSURE TO DRUGS AND CHEMICALS WITH NCTRC AND NICHD, THE RARE SCIENCES INTERNATIONAL, DUKE UNIVERSITY, PROCTER & GAMBLE AND UNIVERSITY OF RHODE ISLAND, THE MEDICATION EXPOSURE PREGNANCY RISK EVALUATION PROGRAM, HMO RESEARCH NETWORK, KEISER PERSONALITY AND VANDERBILT. AND THE ELECTROMAGNETIC WOULD STUDIES WITH THE UNIVERSITY OF HOUSTON, ITI. AND FOUNDATION AND LACTATION STUDIES WITH SEEDER, DUKE AND NICHD. INNER AGENCY COLLABORATIONS TREATING FOR 2 WITH OWH AND CDER AND CDC. OY BEN ZONE STUDIES WITH NTP AND NIEH, CDER AND NCTR. BPA METABOLISM, I'LL GO THROUGH IN MORE DETAIL. NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY, WITH OUR CENTER FOR FOOD SAFETY AND NUTRITION AND CDC AND DIETARY PATTERNS DURING PRECONCEPTIONS PREGNANCY AND RELATED DISORDERS AND BIRTH OUTCOMES. SO JUST IN THIS ONE SLIDE, YOU CAN SEE THERE IS SAY LOT OF COLLABORATION AND WITH DR. BIANCHI'S SLIDES. THERE IS A LOT OF WORK GOING ON ACROSS AGENCIES AND ORGANIZATIONS. TO TALK A LITTLE BIT ABOUT THE MEDICATION EXPOSURE PREGNANCY RISK EVALUATION PROGRAM, I WANTED TO BRING OUT AFTER THE DISCUSSION YESTERDAY - RADIO YOU ALWAYS WISH YOU COULD GO BACK AND REDO YOUR SLIDES AFTER YOU HAVE AN ALL-DAY DISCUSSION, RIGHT? SO I'M NOT GOING TO READ EVERYTHING THAT IS ON THIS SLIDE. JUST TO SAY THAT THIS IS A REALLY AMAZING PROGRAM OF PULLING TOGETHER DATASETS FROM NINE DIFFERENT SITES. THEY KEPT THEIR DATA BUT IT WAS MERGED AND ANALYZED FROM 2001-2008. THE DATA RESOURCES INCLUDED INFORMATION ON MATERNAL AND INFANT CARE CHARACTERISTICS AND MEDICAL CARE FROM AUTOMATED DATABASES. HERE ARE THE STUDIES THAT HAVE BEEN COMPLETED. THERE WAS AWARD-WINNING WELL USE AND EVALUATION OF THE PREVALENCE OF MEDICATION USE VALIDITY STUDIES AND ONGOING STUDIES USINGED THIS, INCLUDE NOW A 3-YEAR FUNDED IN 2016 TO DEVELOP THE ASSOCIATION DURING NEURAL TUBE DEFECTS AND MATERNAL EXPOSURE TO OPIOIDS. AND WHO IS FAMILIAR WITH BPA? RIGHT? SO AT THE WOMEN'S HEALTH PHYSICIAN THERE WAS THIS RISE IN BPA AND BPA IN CONTAINERS AND PLASTICS LEAVING WATER BOTTLES IN YOUR CAR FOR EXAMPLE AND LEACHING OF BPA INTO THE WATER FROM THE BOTTLE. WOMEN WERE VERY FRIGHTENED OF THIS. PREGNANT WOMEN SPELL. AND SO THIS, I THOUGHT IT WAS REALLY INTERESTING THAT THERE IS WIDESPREAD HUMAN EXPOSURE DETECTED IN 95% OF URINE SAMPLES IN U.S. ADULTS. A MAJOR ROUTE OF HUMAN EXPOSURE IS DIETARY AND I KNOW WE PROBABLY AREN'T GOING TO DISCUSS DIETARY ISSUES AS MUCH WITH THIS TASK FORCE, BUT THIS WAS AN EXPOSURE AND AN EXAMPLE OF A REALLY SUCCESSFUL CONSORTIUM. SO THE CONSORTIUM LINKING ACADEMIC AND REGULATORY INSIGHTS ON THE TOXICITY OF BPA. YOU CAN SEE ALL THE PLAYERS THERE PLUS 13 UNIVERSITY-BASED GRANTEES AND WHAT CAME OUT OF THIS IS THAT THERE HAVE BEEN 90 DAY TOXICITY STUDIES BUT NO CHRONIC LONG TERM BPA STUDIES. NOW THEY LAUNCHED THE TWO-YEAR CHRONIC CORE STUDY AND IT IS GOING TO PROVIDE A LOT OF INFORMATION IN PREGNANCY AND IN JUST GENERAL USE. BUT ONE OF THE THINGS THAT REALLY CAME TO MY MIND AS I WAS READING THISSED MANUSCRIPT THAT OUTLINED THIS STUDY IS THAT THE AUTHOR SAID THE STRENGTH OF THIS CONSORTIUM WAS COMMUNICATION. THEY COMMUNICATED WITH THE STAKEHOLDERS WEEKLY AND THEN EVERY OTHER WEEK AND THEN IT REALLY STRENGTHENED THE CONSORTIUM AND I THINK THAT IS AN OPPORTUNITY FOR US TO RECOMMEND MORE COMMUNICATION ACROSS RESEARCH. THE BIOMARKERS AND ENDPOINTS AND OTHER TOOLS ARE BEST WITH FDA AND NIH. WE TALKED ABOUT CLARIFYING TERMINOLOGY AND HOW YOU CAN BRING 10OBGYN INTO A ROOM AND COULDN'T DECIDE ON ONE DEFINITION OR MAYBE STILL BIRTH. WE HAVE TO BE CONSISTENT. WE HAVE TO SPEAK THE SAME LANGUAGE WHEN WE ARE TALKING ABOUT RESEARCH. SO, THIS CLARIFIES TERMINOLOGY RELATED TO BIOMARKERS AND SURROGATE END POINTS. I PULLED OUT TWO FROM THE REPORT SPECIFICALLY RELATED TO PREGNANCY. MONITORING BIOMARKER AND A PREDICTIVE BIOMARKER. AND THIS IS AVAILABLE AS WELL THROUGH THE LINK. WE TALKED ABOUT PREGNANCY REGISTRIES. PREGNANCY REGISTRIES ARE OBSERVATIONAL DATA. WOMEN WHO ARE EXPOSED TO MEDICATION ARE COMPARED WITH CONTROLS. SO ARE THE INFANTS. SO IT'S A GREAT SOURCE OF INFORMATION. AND IT'S AVAILABLE THROUGH THE FDA WEBSITE. WE TALKED ABOUT GUIDANCES SO I'M NOT GOING TO READ THESE BUT I DID HIGHLIGHT THE ONES THAT SPECIFICALLY GIVE GUIDANCE ON STUDY DESIGN AND ANALYSIS AND REPORTING. REMEMBER GUIDANCES ARE FDA'S GUIDANCE TO INDUSTRY. THEY ARE NOT MANDATES. THEY ARE SUGGESTIONS AND EXPECTATIONS THAT WE WOULD LIKE TO SEE. ESTABLISHING A REGISTRY IS THERE AND THEN DRAFT GUIDANCES. SO SEVERAL DEALING WITH RESEARCH REPORTS. I WANTED TO SPEAK BRIEFLY ABOUT OUR MECHANISMS FOR EXTERNAL RESEARCH ENGAGEMENT. THERE ARE CHALLENGES TO CONDUCTING RESEARCH OUTSIDE OF YOUR AGENCIES SOMETIMES. SO WE CREATED SOME MECHANISMS TO DO SO. THE CENTERS OF EXCELLENCE AND REGULATORY SCIENCE AND INNOVATION. IT'S TO FACILITATE COOPERATIVE RELATIONSHIPS AND BUILD STRATEGIC ALLIANCES AMONG FDA AND LEADING ACADEMIC INSTITUTIONS TO PROVIDE THE AGENCY READY ACCESS TO RESEARCH CAPABILITIES, TRAINING AND EDUCATION AND A PLATFORM FOR COMMUNICATION AND DIALOGUE WITH STAKEHOLDERS IN SUPPORT OF FDA'S REGULATORY SCIENCE NEEDS. WE HAVE FIVE AT PLAY. I DID LOOK OVER THIS PROJECT AND WE DO NOT HAVE ANY CURRENTLY THAT ARE RELATED TO PREGNANCY AND LACTATION. SO I SEE THAT AS A GREAT OPPORTUNITY. THIS IS THE FRAMEWORK FOR CERSI AND AREAS IN WHICH THEY PROVIDE SUPPORT AND WORK WITH THE FDA. THE EXTRAMURAL RESEARCH FUNDED THROUGH THE BROAD AGENCY ANNOUNCEMENT SOLICITATION ENCOURAGES SCIENCE AND TECH-BASED PARTICIPATION IN AM DECKIA TO MEET GOALS FOR REGULATORY SCIENCE. THEY FOCUS ON THOSE PRIORITY AREAS THAT WERE LISTED IN THE STRATEGIC PLAN I SHOWED AT THE BEGINNING, ADVANCING REGULATORY SCIENCE. I LOOKED AT OUR BAA AGREEMENTS AND PROJECTS HAVE BEEN FUNDED AND WE CURRENTLY DO NOT HAVE THOSE IN PREGNANCY LACTATION AND AGAIN, ANOTHER OPPORTUNITY. NOW I WANTED TO END WITH AN ASK. I THINK WHEN YOU HAVE AN OPPORTUNITY TO SPEAK TO A GROUP TO REALLY THINK ABOUT, ESPECIALLY THIS GROUP, THAT HAS SUCH AN AMAZING DAY YESTERDAY. I REALLY ENJOYED THE CONVERSATION AND THE CONSENSUS THAT HAPPENED AT THE END. IT WAS REALLY AMAZING. BUT KNOWLEDGE TRANSFER AND APPLICATION OCCURS ACROSS ALL ENVIRONMENTS. SO WHEN WE LOOK AT THE DISCOVERY ENVIRONMENT, WHERE NIH IS A MAJOR PLAYER, WE LOOK AT PRODUCT DEVELOPMENT AND INDUSTRY AND YOU CAN SEE THAT THEY MERGE INTO THE OTHER AREAS. THIS IS SAY FLUID CONTINUUM. FDA WORKS MOSTLY IN THE APPROVAL AND POST MARKET. FDA IS UTILIZES THE SCIENCE THAT IS DISCOVERED IN THE BEGINNING OF THIS CONTINUUM. WE USE THE SCIENCE IN PRODUCT APPLICATIONS AND PRODUCT DEVELOPMENT. SO IT WOULD BE REALLY BENEFICIAL IF WE COULD COMMUNICATE SO THAT WHAT WE DO IN THE EARLY PIPELINE IS SUPPORTIVE OF PRODUCT APPROVAL AND EFFICACY OR ANSWERS QUESTIONS AROUND REGULATORY SCIENCE ABOUT SAFETY AND EFFICACY OF PRODUCTS. SO THERE IS A LOT OF OPPORTUNITY FOR KNOWLEDGE TRANSFER ACROSS THIS ENVIRONMENT. AND AGAIN, WE COLLABORATE MUCH WITH NIH ALREADY BUT I THINK THIS IS AN OPPORTUNITY THAT I HEARD AS I WAS SPEAKING WITH OUR WORKING GROUP ABOUT COMMUNICATING WITH OTHERS. AND LAST, I WOULD JUST SAY THAT OPPORTUNITIES TO STRENGTHEN RESEARCH COLLABORATION ARE NUMBER 1 AWARENESS. REMEMBER THE AH-HAH MOMENTS WE HAD YESTERDAY? WE DIDN'T KNOW THERE WAS THAT MUCH GOING ON IN ALL OF THOSE AGENCIES. COMMUNICATING THAT AND ENGAGING THROUGH RELATIONSHIPS. COLLABORATING. NOT PASSIVELY SHARING INFORMATION BUT ACTIVELY WORKING TOGETHER. DISSEMINATING, NOT JUST THROUGH PUBLICATIONS AND JOURNALS BUT DISSEMINATING TO OUR PARTNERS AND STAKEHOLDERS AND ENGAGING THEM AND THEN ENDURANCE WHICH MEANS CONTINUED COLLABORATION. SOMETIMES WHEN SOMEONE LEAVES AN AGENCY THEY ARE YOUR POINT PERSON, YOU DON'T KNOW WHO TO GO TO. AND SO I THINK IS THERE REALLY AN OPPORTUNITY HERE TO WORK UNDER THESE TWO REALLY STRENGTHEN THE RESEARCH FOR WOMEN, PREGNANT WOMEN AND LACTATING WOMEN. AND I'LL END THERE. THANK YOU VERY MUCH. [ APPLAUSE ] ED. >> DR. BIANCHI: GOOD MORNING. I'D LIKE TO THANK THE ORGANIZERS FOR THE OPPORTUNITY TO PRESENT TODAY, AN INDUSTRY PERSPECTIVE ON THE WORK AT HAND. AND SO, JUST TO GIVE A BRIEF INTRODUCTION AS TO WHY I'M HERE, MY NAME IS CHRISTINA BUCCI-RECHTWEG. I AM COMPLETE DISCLOSURE AND FULL-TIME EMPLOYEE AND STOCKHOLDER FOR NOVARTIS PHARMACEUTICALS ORGANIZATION AND HAVE BEEN IN THE PHARMACEUTICAL INDUSTRY FOR OVER 15 YEARS. I'M A PEDIATRICIAN AND PEDIATRIC INTENSE VISIT. I HAVE BEEN A GLOBAL MEDICAL DIRECTOR SO I HAVE LED PROGRAMS IN PEDIATRIC AND WOMEN'S HEALTH FROM BENCH TO BEDSIDE AND FOR THE LAST 6 YEARS I HAVE BEEN WORKING FULLY IN THE POLICY SPACE AND I'M THE GLOBAL HEAD OF PEDIATRIC AND MATERNAL HEALTH POLICY. WITHIN THE PHARMACEUTICAL INDUSTRY WE DO HAVE INDIVIDUALS WHO HAVE A PASSION AND DEDICATION TO ADVANCING THE RESEARCH FOR BOTH CHILDREN AND WOMEN. AND SO I THINK THAT IS THE FIRST PLACE I WANT TO START TODAY BECAUSE CERTAINLY IN THE LAST 24 HOURS, THERE HAS BEEN A REAL POSSITY OF COLLABORATIVE WORK IN TERMS OF WHAT WE HAVE SEEN UP TOP WITH INDUSTRY. AND I THINK THERE IS TREMENDOUS OPPORTUNITY FOR US IN THIS SPACE S SO AS I SAY THAT, I'M GOING TO PUT UP A SLIDE WHICH IS GOING TO MAKE US ALL SHUDDER. SO WE SAW IS THAT INFORMATION FROM YESTERDAY AND I WANTED TO PROVIDE YOU THE EQUIVALENT PERSPECTIVE FROM WITHIN INDUSTRY. SO THIS DATE AT IS TAKEN FROM CLINICALTRIALS.GOV T HAS BEEN FILTERED SPECIFICALLY FOR PROJECTS IN THE UNITED STATES. AND I'D LIKE TO FOCUS YOUR ATTENTION NOT SURPRISINGLY AUTO WORK TODAY AND THIS POINTER DOESN'T APPEAR TO BE WORKING ON LACTATION, WHICH YOU'RE SEEING ON THE LEFT-HAND SIDE OF THE SCREEN. SO THE FACILITYTHERS WE HAVE APPLIED ARE FOR INTERVERBAL STUDIES. SO INTERVENTIONAL MEANING A DRUG WAS APPLIED TO A PATIENT POPULATION AND THEN WE LOOKED SPECIFICALLY FOR OUTCOMES. IT WAS ALSO FILTERED FOR ALL STUDIES IN EARLY PHASE I-PHASE 4 SO THOSE ARE OUR FIRST IN HUMAN ALL THE WAY THROUGH PORT MARKET AND I LOOKED SPECIFICALLY FOR FUNDERS THAT WERE INDUSTRY FUNDED STUDIES. SO I FILTERED EVERYTHING ELSE OUT. WHAT WE SAW IS THAT THERE ARE CURRENTLY EIGHT COMPLETED LACTATION STUDIES IN THE SYSTEM. THERE ARE CURRENTLY TWO THAT HAVE BEEN SUSPENDED, TERNALINATED OR WITHDRAWN AND THERE ARE SEVEN THAT ARE CURRENTLY ACTIVE. SO IS THERE IS MUCH WORK TO BE DONE ON THE LACTATION SIDE. THANK YOU. WHEN IT RELATES TO PREGNANCY, WE ARE IN A BIT OF A BETTER POSITION. WE HAVE 135 THAT HAVE BEEN COMPLETED. CURRENTLY 35 HAVE BEEN EITHER SUSPENDED, TERMINATED OR WITHDRAWN AND I THINK WE NEED FOE FOCUS ON THIS AND THERE IS CURRENTLY 67 THAT ARE RECRUITING. SO I'M TALKING TO YOU TODAY ABOUT THE INFORMATION ON COLLABORATION. I'M TALKING TO YOU FROM AN INNOVATOR PERSPECTIVE, MEANING I'M TALKING FROM A COMPANY PERSPECTIVE OF DRUGS THAT ARE BEING DEVELOPED FROM BENCH TO BEDSIDE. SO WHEN THESE STUDIES ARE UP HERE, WE ARE THINKING ABOUT NEW MEDICINES THAT ARE BEING DEVELOPED. IT IS VERY TROUBLING THAT 35 OF THE STUDIES THAT ARE CURRENTLY IN THE TOOL ARE SAYING THEY ARE SUSENDED, TERMINATED OR WITHDRAWN. SO ONE OF THE FUNDAMENTAL COMPLEXITIES WE HAVE WITHIN THE INNOVATOR DRUG DEVELOPMENT INDUSTRY IS THAT WE WORK WITHIN HIGHLY REGULATESSED ENVIRONMENT IN A VERY TRADITIONAL MANNER. TRADITIONAL MEANING NON-CLINICAL AND CLINICAL STUDIES DESIGNED TO TRULY TEST EFFICACY AND SAFETY OF A DRUG. AND ALL OF YOU WHO WORKED IN THIS SPACE KNOW THAT THESE STUDIES IN WOMEN WHO ARE PREGNANT AND LACTATING WOMEN ARE VERY COMPLEX AND DON'T REALLY WORK WELL IN A TRADITIONAL RESEARCH MODEL. SO A GREAT OPPORTUNITY THAT WE HAVE AHEAD OF US IS TO THINK ABOUT THE TOOLS WE HAVE TODAY THAT ALLOW US TO ADAPT OUR THINKING ABOUT RESEARCH AND PREGNANT WOMEN. CAN WE BETTER UTILIZE EXISTING INFORMATION? CAN WE USE BETTER SENSE OF ANALYTICAL TOOLS? CAN WE USE BETTER MODELS OF RESEARCH? AND CAN WE USE ALL THE WONDERFUL TECHNOLOGIES THAT ARE EVOLVING TO BERT TAP INTO WOMEN WHO EVERY PREGNANT WOMEN I KNOW TODAY IS PLUGGING THEIR INFORMATION INTO AN APP. ARE THERE BERT WAYS FOR US TO ACCESS ANDULATE LICE INFORMATION SO WE CAN FACILITATE THE RESEARCH THAT NEEDS TO BE DONE. SO IN TERMS OF COLLABORATION, AS I MENTIONED IN THE PHARMACEUTICAL INDUSTRY WE ARE A VERY HIGHLY-REGULATED INDUSTRY. HIGHLY-REGULATED SECTOR IN TERMS OF THE WAY WE GO ABOUT THE DEVELOPMENT OF OUR THERAPIES BUT IN THE WAY THAT OUR ACCESS TO THE MARKETS ARE CONTROLLED IN INDIVIDUAL GOVERNMENTS. ALSO REMEMBER PRESCRIPTIONS ARE HIGHLY REGULATED. DISPENSING PRACTICE IS HIGHLY REGULATED IN ADDITION EVEN THOUGH WE HEAR OTHERWISE IN THE NEWS, THE WAY PRICING IS SET IS HIGHLY REGULATED. SO EVERYTHING WE DO IS VERY TIGHTLY CONTROLLED. SO WE HAVE VERY STRICT RULES ABOUT HOW WE CAN COLLABORATE. SO ONE OF THE FUNDAMENTAL WAYS IN WHICH COMPANIES CAN ACTUALLY GET-TOGETHER, WHICH IS NOT THOUGHT TO BREAK ANTITRUST LAW WITH WHICH THERE IS EXTENSIVE ANTITRUST LAW S THROUGH TRADE ORGANIZATIONS. SO IN THE UNITED STATES, WE DO HAVE TRADE ORGANIZATIONS, ONE THAT EVERYONE HAS SEEMED TO HAVE HEARD ABOUT, PHARMA, BUT THERE IS ALSO ANOTHER TRADE ORGANIZATION CALLED BIO. AND IN BIO, THERE HAPPENS TO BE A ORGANIZATION THAT WORKS SPECIFICALLY TO ADDRESS OPPORTUNITY FOR PREGNANT AND LACTATING WOMEN THROUGH AN ORGANIZATION CALLED BIOSAFE. NOW BIOS KNOWN AS A BIOTECHNOLOGY INNOVATION ORGANIZATION. IT'S MEMBERS ARE INVOLVED IN A WHOLE HOST OF DIFFERENT RESEARCH AND DEVELOPMENT ACROSS NOT ONLY DRUG DEVELOPMENT BUT ALSO AGRICULTURE AND OTHER INDUSTRIAL AND BIOTECHNOLOGY PRODUCTS. SO OVER 200 COMPANIES AND ACTUALLY MORE, THAT ARE PART OF THE BIOTECHINOLOGYO INNOVATION ORGANIZATION. AND BIOSAFE IS A PRE-CLINICAL SAFETY COMMITTEE. THEY ARE AN INTERNAL RESEARCH FOR BIO, SO IS THAT BIO IS A TRADE, CAN WORK COLLABORATIVELY ACROSS A HOST OF DIFFERENT MULTISTAKEHOLDER GROUPS PROVIDE GUIDANCE AND ADVICE, TO RESPOND SPECIFICALLY TO SCIENTIFIC CHALLENGES OR REGULATORY CHALLENGES WE MAY HAVE. AND THE GOAL HERE IS TO ADVANCE THE RESEARCH SPACE. SO WE HAVE A PERFECTS OPPORTUNITY TO WORK DIRECTLY WITH THE TRADE THROUGH THE BIOSAFE SUBGROUP. NOW THERE IS ALSO AN IMPORTANT COMPONENT TO THINK ABOUT IN TERMS OF HOW THE INDUSTRY WORKS AS I SAID. I USED THE WORD, HIGHLY-REGULATED. EVERYTHING WE DO FROM THE STANDPOINT OF OUR CHEMICAL IDENTIFICATION THROUGH TO MANUFACTURING, HAS GUIDANCE IN PLACE THAT WHILE WE HEARD IT'S A RECOMMENDATION, YOU DON'T GO OUTSIDE OF RECOMMENDATION. THIS IS THE STANDARD. YOU DON'T GO BELOW THE STANDARD. YOU WORK TO ACHIEVE THE STANDARDED AND SUPERSEDE THE STANDARD. AND THE INTERNATIONAL CONSENSUS BODIES THAT MOST OF THE KEY REGULATORY AGENCIES GLOBALLY TURN TO TO LOOK FOR INTERNATIONAL STANDARD S INTERNATIONAL COUNT FOR HARMONIZATION OF TECHNICAL REQUIREMENTS. NOW WHILE INDUSTRY DOESN'T HAVE A ROBUST SET OF STUDIES IN THE CLINICAL SPACE, WHAT I CAN SAY FROM A NON-CLINICAL STANDPOINT, THIS IS SAY PLACE OF STRENGTH IN PREGNANCY AND LACTATION. FOR EVERY NEW PRODUCT THAT HAS TO BE REVIEWED BY REGULATORY AGENCIES, WE HAVE TO PUT FORWARD NON-CLINICAL DOSE AS THAT INCLUDE INFORMATION ON FERTILITY, PRE AND POST NATAL DEVELOPMENT ON DEVELOPMENT AND REPRODUCTIVE TOXICOLOGY. EVERY PRODUCT HAS A TREMENDOUS SET OF NON-CLINICAL DATA WHICH WE HAVE NOT CURRENTLY TAPPED INTO ADEQUATELY TO UTILIZE THAT INFORMATION FOR FUTURE ANALYTICS. AND I THINK THAT THIS IS A WONDERFUL OPPORTUNITY FOR US TO CONSIDER HOW WE COULD BETTER UTILIZE THAT IS INFORMATION AND CONSIDER ALTERNATIVE APPROACHES SUCH AS APPLYING PHARMACOKINETIC APPROACHES AND PHARMACODYNAMIC AND PHARMACOMETRIC APPROACHES TO UNDERSTANDING EXISTING DATA. WHAT WE HAVE DONE VERY NICELY IS PUT TOGETHER A LINE AND CONSENSUS ON SOME VERY SPECIFIC GUIDANCES THAT ARE SPECIFIC TO ALL OF THOSE NON-CLINICAL STUDIES WE NEED TO DEVELOP FOR PREGNANCY, LACTATION AND FERTILITY. YOU CAN SEE, I HAVE LISTED THEM HERE. THE ICH -- I APOLOGIZE, I DIDN'T PUT THE LINK HERE. IT HAS A WEBSITE ON LINE WHERE YOU CAN GO IN, LOOK UP THE S FOR SAFETY GUIDANCE. M IS MULTIDISCIPLINARY. THERE IS ALSO Q FOR QUALITY DOCUMENTS. THESE ARE THE ONES SPECIFIC TO PREGNANCY LACTATION. S5 IS ON FERTILITY, EARLY EMBRYONIC DEVELOPMENT, AND PRE AND POST NATAL DEVELOPMENT AND EMBRYO DEVELOPMENT. S6 IS GENDER AND REPRODUCTIVE GOVERNMENT IS REPRODUCTIVE TOXICOLOGY. S9 IS CANCER SPECIFIC TO REPRODUCTIVE TOXICITY AND M3 IS ON REPRODUCTIVE TOXICOLOGY FOR MEN, WOMEN AND WITH CHILD BEARING POTENTIAL AND PREGNANT WOMEN. AND DR. MOFFIT WILL TALK A BIT MORE ABOUT THE PRE-CLINICAL CONSIDERATIONS THAT I'M GOING TALK ABOUT NOW. AND THAT IS TO TURN TO THE FOCUS ON PUBLIC/PRIVATE PARTNERSHIPS AND IT WAS MENTIONED YESTERDAY THAT THERE IS AN ORGANIZATION CALLED ILSI. AND IT HAS WITHIN IT THE HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE AND THEY HAVE A SPECIFIC DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY GROUP OR HESI AND DART GROUP. THIS IS SAY WONDERFUL FORUM, MULTISTAKEHOLDER FORUM THAT INCLUDES REG SIMILARITIES AND INCLUDES INDUSTRY AND INCLUDES ACADEMICS, WHOSE WHOLE FOCUS IS TO ADVANCE THE PRE-CLINICAL SAFETY CONSIDERATIONS AROUND REPRODUCTIVE TOXICOLOGY. SO THERE HAS BEEN A TREMENDOUS AMOUNT OF COLLABORATIVE WORK THAT HAS GONE ON THROUGH ILS AND INCLUDE DEVELOPMENTAL TALKS, MALE AND FEMALE FERTILITY, JUVENILE TOXICOLOGY AND THEY REALLY WORK VERY CLOSELY TO DEVELOP MULTIDISCIPLINARY GUIDANCE THAT ARE RELATED TO DEVELOPMENTAL AND REPRODUCTIVE TOXISHES. OVER THE COURSE OF THE LASH 15 YEARS, THERE HAVE BEEN SOME INCREDIBLY IMPACTFUL PUBLICATIONS. I PULLED OUT JUST THREE BUT I HAVE THE LINK INCLUDED HERE WHERE YOU CAN LOOK THROUGH AND THE STRENGTH OF THE ILSI GROUP IS THEY CAN PULL FROM ACROSS ALL OF INDUSTRY, AND ALL OF ACADEMIA AND ALL REGULATORY AGENCIES AND PUT TOGETHER SOME VERY COMPELLING AND ROBUST SETTLE OF PUBLICATIONS THAT ARE -- SETS -- ANALYZING INFORMATION AND PUTTING OUT RECOMMENDATIONS. THEY LOOKED AT RODENT MODELS OF EMBRYO FETAL TOXICITY FROM 379 PHARMACEUTICALS AND ABLE TO REPORT ON SYSTEMIC DOSE AND DEVELOPMENTAL EFFECTS IT'S BEEN PUBLISHED. AND I PUT UP THE THREE MOST RECENT OR WHAT I CONSIDER TO BE COMPELLING FOR THIS GROUP, ARTICLES THAT YOU SHOULD LOOK AT IN TERMS OF THE CONTENT AND THE QUALITY OF WHAT ILSI CAN DO COLLABORATIVELY FOR US. THERE ARE ALSO -- I'M GOING SKIP BECAUSE I GOT THE YELLOW SIGNAL. BUT I WANTED TO HIGHLIGHT FOR YOU THAT THERE ARE MULTIPLE PUBLIC/PRIVATE PARTNERSHIPS. I HIGHLIGHT HERE FOR YOU THE INNOVATIVE MEDICINE INITIATIVE, THE LARGEST EUROPEAN PUBLIC-PRIVATE PARTNERSHIP THAT FOCUSES SPECIFICALLY ON MEDICATIONS DEVELOPMENT. THERE HAPPENS TO BE ONE SPECIFIC CALL THAT WENT OUT THROUGH THE IM. THEY INCLUDED A VERY NICE PREGNANCY COMPONENT AND THAT IS THROUGH THE PROTECT LAUNCH WHICH WAS A PHARMACOEPIDEMIOLOGICAL RESEARCH OF OUTCOMES OF THERAPEUTICS BY THE EUROPEAN CONSORTIUM. WHAT THEY REALLY FOCUSED ON WAS HOW TO BEST HAVE IN MODERN MEANS OF DATA COLLECTION, WHICH IS ONE OF THE FUNDAMENTAL THINGS WE CAN LOOK AT WITH THIS GROUP IN TERMS OF DATA GENERATION. AND THERE IS SAY PUBLICATION ON THE RESULTS THAT CAME FROM THEIR LOOKING SPECIFICALLY AT LIFESTYLE AND RISK FACTORS FROM OVER 2000 PREGNANT WOMEN. AND THE WHOLE POINT WAS TO SEE WHETHER OR NOT THEY COULD UTILIZE THESE MODERN TECHNOLOGIES TO GATHER INFORMATION AS CONSISTENTLY AS OTHER MORE STANDARDIZED, MORE TRADITIONAL MEANS OF COLLECTING DATA. THE IMI ALSO HAS A LAUNCH WE EXPECT TO COME OUT IN THE FALL WHICH IS ONE THEY KNOW OUR COLLEAGUES FROM THE FDA PARTICIPATED IN AN EARLY CONSULTIVE WORKSHOP ON. AND THIS REALLY AROSE FROM THE EIWH'S CALL FOR SAFETY OF MEDICINE DURING PREGNANCY AND LACTATION. NOW, THE REASON I BROUGHT THIS PARTICULAR CALL-UP FOR US TO DISCUSS IS THAT THIS PROPOSAL REALLY IS WORKING TO ADDRESS THE UNMET NEED FOR SCIENCE AND DATA-DRIVEN APPROACH TO DEFINE THE STANDARDS FOR GENERATING DATA ON MEDICINES USED DURING PREGNANCY AND BREASTFEEDING. SO THEY ARE WORKING ON OR HOPING TO WORK ON EXACTLY WHAT I THINK THIS TASK FORCE IS LOOKING TO ALSO SIMILARLY DO HERE IN THE U.S. AND THEY ARE DOING THIS BECAUSE THEY KNOW THERE IS A NEED TO PROVIDE BETTER INFORMATION. SO HOW DO WE GO ABOUT DOING THIS? THIS CALL CURRENTLY INCLUDES 15 MEMBER COMPANIES FROM THE EUROPEAN PHARMACEUTICAL TRADE ASSOCIATION AND AGAIN, WE ANTICIPATE THAT THE CALL LAUNCH WILL GO IN OCTOBER SO THERE IS OPPORTUNITY FOR COLLABORATION HERE. I WANT TO JUST FINISH VERY QUICKLY, I KNOW I GOT THE RED, ON MULTISTAKEHOLDER FORUMS. IMMENSED TWO HERE THAT HAVE HAD VERY STRONG INDUSTRY COLLABORATION. I'M STARTING AGAIN WITH THE EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE. THIS IS A LARGE GROUP OF INTERESTED PARTIES TO UNDERSTAND HOW BOAST ADVANCE GOOD CLINICAL PRACTICE IN RESEARCH. NOW THIS PARTICULAR POSITION STATEMENT ULTIMATELY WAS DRAFTED BY THE EUROPEAN FORM FOR GOOD CLINICAL PRACTICE CAME FROM THE FACT THAT IN CLINICAL TRIALS, IT IS A STANDARD TO NOT -- PREGNANT WOMEN. ALSO THE STANDARD THAT IF A WOMAN BECOMES PREGNANT DURING A TRIAL TO AUTOMATICALLY DISCONTINUE HER FROM THE STUDY. NO DISCUSSION. IT'S JUST THE END. CLEARLIYSHIRE WONDERFUL OPPORTUNITY TO GENERATE INFORMATION. IF YOU HAVE A PATIENT WHO BECOMES PREGNANT DURING THE COURSE OF A TRIAL, THIS IS AN IDEAL POPULATION TO UNDERSTAND THE CLINICAL PHARMACOLOGY, PHARMACOKINETICS AND PHARMACODYNAMICS AND OUTCOMES OF THE PREGNANCY. BECAUSE YOU HAVE A NATURAL PATIENT WHO IS IN THE STUDY ALREADY. AND SO, THEY CAME OUT WITH A PHYSICIAN STATEMENT THAT SAID SHOULD A WOMAN BECOME PREGNANT DURING THE COURSE OF THE STUDY, SHE NEEDS TO HAVE A COUPLE OF OPPORTUNITIES PROVIDED TO HER. NUMBER 1 TO MEET WITH THE RESEARCHER TO UNDERSTAND WHAT IS THE IMPLICATION FOR HER AND HER BABY. IT'S VERY POSSIBLE THAT DRUG IS NOT A TAT JEN. DOES SHE REALLY NEED TO DROP OUT OF THE STUDDIE? WHETHER OR NOT SHE SHOULD REMAIN IN THE STUDY, WHAT FURTHER DATA COLLECTION COULD OR WILL BE DONE AND WHAT FUTURE THERAPEUTIC MANAGEMENT AND PRENATAL CARE SHOULD SHE RECEIVE? AND THAT SHE SHOULD HAVE THE OPPORTUNITY TO KNOW WHAT MEDICATIONS SHE WAS ON UNLESS SHE TAKES AN INFORMED POSITION NOT TO UNBLIND. NOW I THINK THE THING FOR US TO THINK ABOUT IN CLINICAL TRIALS FOR DEVELOPMENT OF INNOVATIVE MEDICATIONS IS THAT IN ALL OF OUR COMPANIES, THERE HAVE BEEN SITUATION WHEREAS WE HAD THERAPIES THAT WOMEN HAVE BEEN ON FOR CHILD BEARINGER AND THEY BECOME PREGNANT. ALL OF OUR COMPANIES HAD EXPERIENCES WHERE THE WOMEN HAVE NOT BEEN UNBLINDED AND THEY HAVE TAKEN A DECISION TO TERMINATE THEIR PREGNANCY. AND WE HAVE ALL HAD HAD THOSE EXPERIENCES WHERE THOSE PREGNANCIES ARE PATIENTS WHO ARE ON PLACEBO. SO WE HAVE TO THINK ABOUT WAYS FORWARD. WE HAVE TO THINK ABOUT HOW WE CHANGE THE RESEARCH ENVIRONMENT SO THAT WHEN WE DO HAVE MORE STUDIES AVAILABLE FOR WOMEN TO PARTICIPATE IN WHO MIGHT BE PREGNANT OR LACTATING, THAT WE CAN DO SO IN A VERY PRAGMATIC AND PRACTICAL MANNER. SO IS THIS IS SOMETHING ELSE FOR US TO THINK ABOUT AS THE CONDUCT OF RESEARCH. AND THEN THERE IS ADDITIONALLY A MULTISTAKEHOLDER FORUM THROUGH THE DIA MEDICINE AND PREGNANCY AND I JUST WANTED TO LET YOU KNOW THAT IN THE LAST THREE YEARS, THERE HAVE BEEN MULTIPLE PUBLICATIONS THAT HAVE RESULTED FROM THESE FORUMS WITH STRONG MULTISTAKEHOLDER REFLECTIONS ON HOW BEST TO MOVE FORWARD SO WE CAN IN FACT DEVELOP SAFE AND EFFECTIVE MEDICINES IN PREGNANT AND LACTATING WOMEN. SO THANK YOU VERY MUCH FOR YOUR TIME. [ APPLAUSE ] >> DR. SPONG: THANK YOU VERY MUCH FOR ALL THREE PRESENTATIONS SETTING THE STAGE FOR THIS PANEL WHERE WE WILL COME UP WITH RECOMMENDATIONS FOR THE COORDINATION OF AND COLLABORATION OF RESEARCH WITHIN THE FOLLOWING SPACE AND I ANTICIPATE THAT THIS WILL CONTINUE EVEN BEYOND THE FEDERAL SPACE WHICH IS ALL GOOD BECAUSE THE TASK FORCE ULTIMATELY WILL INCLUDE NON FEDERAL ENTITIES DISCUSSION AS WELL. I DO WANT TO GIVE THE OPPORTUNITY FOR THE OTHER PANELISTS,ES GARY GIBBONS, JEANNE SHEFFIELD, SAYEEDHA UDDIN AND A LEN LEN TO GIVE ADDITIONAL COMMENTS - KRISTI LENGYEL THEN WE WILL OPEN IT UP FOR A BROADER DISCUSSION WITH THE ENTIRE GROUP. >> I AM IN A SPACE NA WHERE WE TRY TO EDUCATE WOMEN, HELP WOMEN SHARE IN DECISION-MAKING ABOUT THEIR PREGNANCIES ABOUT THEIR BREASTFEEDING EXPERIENCE. SO, FROM MY POINTED OF VIEW, I'M REALLY CONCERNED ABOUT COMMUNICATION TRANSLATING RESEARCH FINDINGS INTO INFORMATION FOR PREGNANT WOMEN. AND USUALLY WHEN I TALK TO PEOPLE, I ASK THEM TO TURN OFF THEIR CELL PHONES BUT I'M GOING TO ASK ALL OF YOU IF YOU WOULD JUST TAKE ONE MOMENT HERE, AND THERE IS A GUEST CONNECTION, BUT IF YOU HAVE YOUR CELL PHONE HANDY, JUST GOOGLE IN, AND I'M NOT TALKING GOOGLE SCHOLAR HERE. GOOGLE IN PREGNANCY NAUSEA WEED AND BLOG. YES. PREGNANCY, NAUSEA WEED AND BLOG. WEED. AS IN NATURAL HERBAL PREPARATION. AS IN MARIJUANA. SO, I WANT YOU TO BE AWARE. AND YOU CAN HAVE A LOT OF FUN WITH THIS. HOPEFULLY NOT WHILE I'M TALKING. LET'S RETURN TO OUR DISCUSSION. BUT I THOUGHT YOU TO BE VERY, VERY AWARE OF WHERE WOMEN ARE GOING FOR INFORMATION. AND MARIJUANA IS A PARTICULAR CONCERN RIGHT NOW BECAUSE IT HAS BECOME LEGALIZED. WOMEN DON'T NECESSARILY GO TO.GOV SITES TO FIND INFORMATION ABOUT SUBSTANCES THEY ARE USING DURING PREGNANCY AND ALTHOUGH IN MANY SURVEYS, INCLUDING THE LISTENING TO MOTHER SURVEY THAT WAS DONE A NUMBER OF YEARS AGO BY DICK CLARK, PHYSICIANS, WOMEN'S PHYSICIANS ARE GENERALLY WHO THEY TURN TO FOR INFORMATION ABOUT SUBSTANCES THAT ARE ABOUT ANYTHING ABOUT THEIR PREGNANCY. THAT IS IF YOU ASK A WOMAN ACCIDENT A TRUSTED SOURCE, THEY WILL SAY THEIR PHYSICIANS AND I TEACH A LOT OF CHILDBRTH CLASS SYSTEM AND TRY TO DO THIS WITH EVERY CLASS. WHO DO YOU TURN TO AS A TRUSTED SOURCE? AND THEY USUALLY SAY THEIR PHYSICIANS. BUT THEN I SAY, WHERE DO YOU GO JUST FOR INFORMATION AND THEY GO TO BLOGS. THEY GO TO INTERNET BLOGS. AND IF YOU LOOK AT WHAT THEY ARE GETTING ON THE INTERNET ABOUT MARIJUANA, IT'S A NATURAL PRODUCT. I USED IT BEFORE I WAS PREGNANT. THERE ARE DEFINITELY BENEFITS TO USING IT. I HAD TWO HEALTHY CHILDREN AND I SMOKE MARIJUANA THROUGHOUT MY PREGNANCY. THEY ARE TELLING ME I SHOULD TAKE SOME CHEMICALS TO CONTROL MY NAUSEA BUT I WOULD MUCH RATHER USE A NATURAL PRODUCT. SO MY POINT IS THAT AS WE DEVELOP A RESEARCH STRATEGY FOR PREGNANT AND LACTATING WOMEN, WE ALSO NEED TO THINK ABOUT HOW WOMEN TAKE IN INFORMATION ABOUT THE RESEARCH FINDINGS. AND ORGANIZATIONS LIKE ACNM, A COG, A NUMBER OF ORGANIZATIONS TRY TO PROVIDE EDUCATION BUT I'M NOT SURE WE HAVE DUG DOWN. I HAVE GREAT HOPE IN THE PCORI STUDY AND LOOKING AT PREGNANCY IN LIVE TIME, BUT I THINK WE NEED TO UNDERSTAND HIGHWAY WOMEN HOW WOMEN MAKE DECISIONS IN PREGNANCY AND WILL I DON'T THINK WE HAVE REALLY DONE THAT YET. >> I'M JEANNE SHEFFIELD, JOHNS HOPKINS. I WANT TO THANK THE GROUP FOR THE OPPORTUNITY TO SPEAK. I HAVE BEEN INCREDIBLY IMPRESSED BY THE NUMBER OF COLLABORATIONS I HAVE SEEN DISCUSSED OVER THE LAST 24 HOURS. BUT I'M ALSO EQUALLY DAUNTED OR IMPRESSED BY THE DISTANCE WE STILL HAVE TO GO, ESPECIALLY AFTER LISTENING TO ANN'S TALK YESTERDAY. IT WAS A FASCINATING TALK BUT IT WAS QUITE DAUNTING. I COME THAT THE WEARING SEVERAL DIFFERENT HATS. I CERTAINLY FOREMOST HAM A CLINICIAN AND HAVE BEEN FOR OVER NUMBER OF VERY BUSY AND LABOR AND DELIVERIES AND CLINICS AND I CAN'T BEGIN TO COUNT THE NUMBER OF TIMES THAT PEOPLE HAVE ASKED ME, IS THIS SAFE FOR MY BABY? AND THE DILEMMA WE GET INTO AS PHYSICIANS YOU, YOU WANT TO BE POSITIVE AND SAY YES, YOU SHOULD DO THIS. BUT YOU'RE SAYING THAT BASED ON LITTLE OR NO INFORMATION. AND SO YOU END UP DOING YOUR WAFFLING RISK-BENEFIT TYPE DISCUSSIONS. BUT THE IMPORTANCE FROM A CLINICAL STANDPOINT FROM A CLINICIAN STANDPOINT IS, WE NEED MORE DATA AND WE NEED IT PRETTY QUICKLY AND WE NEED GOOD-QUALITY DATA. I ALSO COME AT IT FROM A RESEARCHER STANDPOINT FROM THE WAY BACK WHEN, 20 YEARS AGO, BASIC SCIENCE, TO A FEW RANDOM PK/PD STUDIES TO MULTICENTER TRIALS VERSUS TRYING TO DO SINGSEL CENTER TRIALS AND THE ACTIVITIES IN THAT. AND FINALLY COME AT IT FROM A MOM. MY SON TURNED 21 YESTERDAY AND I ALSO SAT ON THE OTHER SIDE OF THE TABLE GOING, ARE YOU SURE I CAN DO THIS? IS IT SAFE EVEN THOUGH I CAN DO THE SAME THING AND LOOK ON LINE. SO I JUST WANTED TO, WHEN I WAS TALKING YESTERDAY AND KNOWING I HAD TO TALK ABOUT COLLABORATION AND COORDINATION, I JOTTED DOWN A FEW NOTES AND WE TALKED A LITTLE BIT ABOUT IT THIS MORNING SO I WON'T GO NUTS AND THE REPEAT EVERYTHING. BUT I THINK THE BIG OVERARCHING THEME YESTERDAY WAS THE POSSITY OF DATA AND WHAT WE NEED TO DO ABOUT IT. SO IS THERE IS SAY DESPERATE NEED NOT JUST FOR BASIC SCIENCE AND PK/PD AND THE TRADITIONAL TRIALS BUT THE BIG THING WE DESPERATELY NEED IS GOOD, LARGE, WELL-DESIGNED, CLINICAL TRIALS. AND I THINK WE ALL AGREE WITH THAT. I THINK HOWEVER, THERE IS A LOT OF ROAD BLOCKS TO DOING THOSE BIG TRIALS. AND THEY THINK IS WHERE WE EEDED TO AT LEAST PART OF THIS DISCUSSION FROM YESTERDAY AND TODAY AND THE REPORT WE ARE FINALLY GOING TO PUT OUT A YEAR FROM NOW, NEEDS TO CENTER ON HOW TO MOVE FORWARD ON GETTING THAT DATA. YES THERE ARE 4 MILLION WELL BIRTHS WE CAN STUDY THESE PEOPLE BUT WHEN YOU STARTED TO NARROW DOWN TO INDIVIDUAL PROBLEMS YOU'RE TALKING ABOUT SOMETHING THAT MAY BE LIKE YOU MENTIONED YESTERDAY, MAYBE 200,000 WOMEN HAVE IT OR MAYBE 27 WOMEN HAVE IT A YEAR. SO, YOU HAVE GOT TO -- AND THESE WOMEN ARE SPREAD ALL AROUND THE COUNTRY. SO A SINGLE CENTER, EVEN ONE WHERE I CAME FROM, A VILLAGER LARGE CENTER, NOT GOING TO BE ABLE TO ADDRESS THOSE PROBLEMS WELL. AND SO, I THINK YOUR DIRE NEED IN OBSTETRICS, I THINK YOU HAVE TO HAVE LARGE, WELL-DESIGNED, MULTI-CENTER TRIALS. AND I WANT TO PUT UP THE NICHD, NOT BECAUSE YOU BROUGHT ME IN HERE, BUT BECAUSE I THINK THE NICHD HAS BEEN GREAT ABOUT DESIGNING THE NETWORKS AND PUTTING A LOT OF EFFORT EFFORT INTO NETWORK TRIALS AND INK DR. BIANCHI TALKED ABOUT THE NETWORK TYPES THAT ARE OUT THERE RIGHT NOW IN OUR WORLD AND THE NECESSITY OF THEM. IT TAKES A ORGANIZED INFRASTRUCTURE OF STUDY, DESIGN AND ANALYSIS, AND COORDINATION AND THEN PARTNERS A NUMBER OF ACADEMIC CENTERS. AND I LOVE TO SEE PARTNERSHIP AT SOME POINT WITH A MEMBER OF THE INDUSTRY. INDUSTRY ALSO PUBLIC-PRIVATE SECTOR PARTNERSHIP. BUT IT TAKES THAT. SO IT KIND OF RELIES ON THE GREAT INFRASTRUCTURE THE GOVERNMENT IS FAMOUS FOR. THE NICH DO. PUT UP HAS A BEAUTIFUL DESIGNED INFRASTRUCTURE SETTINGS AND THEN IT ALLOWS DIFFERENT ACADEMIC CENTERS WHERE THIS CENTER MAY HAVE 100 PATIENCE AND THIS ONE MIGHT HAVE 30. BUT ALL DIFFERENT ETHNICITIES AND GROUPINGS AND DIFFERENT SOCIOECONOMIC STATUSES TO, BRING IN THE POWER OF PLACES ALL AROUND THE COUNTRY. AND SO, I'D LIKE TO PUT THAT UP THERE AS A MODEL FOR OBSTETRIC RESEARCH. WE ARE ALL VERY PROUD OF OUR SINGLE-CENTER STUDIES BUT I THINK IT'S A MODEL OF GOOD OBSTETRIC RESEARCH THAT COULD CHANGE CLINICAL PRACTICE HERE IN THE UNITED STATES AND WORLDWIDE. I THINK YOU HAVE GOT TO SET IT UP OR AT LEAST SET UP LARGE NETWORK-TYPE SYSTEMS WITH THE PUBLIC-PRIVATE SECTOR AND AGAIN, I'D LOVE TO JUMP IN WITH INDUSTRY. AND THE ONLY OTHER THING I WANT TO MENTION SILENT REGISTRIES. I'M A HUGE BELIEVER IN THE REGISTRIES THAT YOU HAVE PUT TOGETHER WITH THE FDA AND ALL THAT. AS A CLINICIAN TRYING TO PUT DATA IN TO SAID REGISTRIES, IT COULD BE A LITTLE HON REAND TRYING TO GET -- I DATA OUT ALSO. JUST SO MORE EASILY ACCESSIBILITY FOR ME SITTING IN MY OFFICE TALKING TO A PATIENT ACROSS THE TABLE FROM ME, GETTING DATA OUT OF THE REGISTRIES ALSO GOOD REALTIME DATA WOULD BE GREAT TOO. BUT WITH, THAT I'LL STOP. I KNOW THERE IS SAY MILLION THINGS I COULD SAY BUT I'LL STOP. I THINK WE HAVE GOT SOME GREAT MODELS. I THINK WE NEED TO PUT A LOT MORE EFFORTS INTO USING THOSE MODELS THAT ARE ALREADY OUT THERE. >> THE OTHER THING THAT SEEMED INTERESTING, OR KEPT JUMPING OUT, IS THE POSSITY OF DATA. IN REMEMBERS TESTIFY BEING ABLE TO -- THE ROLE OF THE FEDERAL GOVERNMENT AND HOW WE CAN FOSTER COLLABORATION AND COORDINATION. AND WHAT IS IT THAT NEEDS TO BE DONE? THERE IS SOME SORT OF INNOCENTIZATION PERHAPS THAT NEEDS TO HAPPEN -- TO BE ABLE TO ENCOURAGE TREES TRIALS. ALSO THE DRUGS WE THOUGHT WERE SAFE OR EFFECTIVE THAT NOW WE REALIZE WE DON'T KNOW AS MUCH AS WE THOUGHT WE KNEW ABOUT THE DRUGS. OR THE DOSING FOR MANY OF THE MEDICATIONS THAT PERHAPS NEEDS TO BE INCREASED IN THIRD TRIMESTER. SO THE NEW STUFF AND EXISTING STUFF. WHATEVER WE THINK WE KNOW, IT DOESN'T SOUND LIKE WE KNOW AS MUCH AS WE THINK WE DO. AND IN TERMS OF THE FOSTERING THE COORDINATION AND COLLABORATION, JUST MAYBE FINDING OUT WHO THOSE BARRIERS HAS SOME IDEA OF WHAT THEY THINK BUT MAYBE IN OUR REPORT, JUST STATING THEM AND THEN TRYING TO FIGURE OUT OR COME UP WITH WAYS OR AT LEAST PUTTING IT OUT THERE THAT THESE ARE THE BARRIERS AND THEN MAYBE GETTING SOME MORE I THINK PUT IN TERMS OF HOW TO ADDRESS THEM -- INPUT -- >> SO GOOD MORNING. I'M KRISTI LENGYEL DIRECTOR OF THE PATIENT ADVOCACY AT UCB. DELIGHTED AND HONORED TO BE THAT THE TABLE TODAY SITTING AROUND WITH ALL OF THESE COLLEAGUES, ESTEEMED LEGS, WHICH I ALSO CALL FRIENDS AFTER YESTERDAY'S DISCUSSION OF ALL THE GREAT WORK THAT IS DONE. SO THANK YOU AGAIN FOR THE OPPORTUNITY TO PRESENT TO YOU TODAY. SO UC DOES. ANOTHER ACRONYM OR ALPHABET SOUP THIS MORNING. A GLOBAL BIOPHARMACEUTICAL COMPANY BASED IN BRUSSELS, BELGIUM AND OUR U.S. HEADQUARTERS ARE NEAR ATLANTA GEORGIA. OUR AM SUSPICION TO TRANSFORM THE LIVES OF PEOPLE LIVING WITH SEVERE DISEASES. WE FOCUS ON NEUROLOGY, IMMUNOLOGY AND BONE HEALTH. PUTTING PATIENTS AT THE CENTER. WE RECOGNIZE THE RADICAL CHANGES AND THE ECOSYSTEM OF CARE AND WE ARE CONTINUOUSLY EVOLVING TO DELIVER PATIENT VALUE. WE REALLY TRY TO AIM TO HAVE A BETTER UNDERSTANDING OF THE VARIOUS EXPRESSIONS OF A DISEASE EMBEDDED IN THE REAL-LIFE EXPERIENCES OF THE PATIENTS AND THEIR CAREGIVERS AND MEET THOSE NEEDS WITH SPECIFIC PATIENT POPULATIONS. AND I'M PLEASED TODAY TO SHARE WITH YOU THAT U CDs FOCUSED ON THE VULNERABLE POPULATIONS. WE HAVE AN ENTIRE TEAM DEDICATED TO THAT AND WHAT WE DEFINE AS VULNERABLE POPULATIONS RELEVANT TO TODAY, IS WOMEN OF CHILD BEARING AGE AND LACTATING WOMEN. AND I'D LIKE TO SHARE OUR LONG-STANDING COMMITMENT AT UCB FOR ADVANCING CARE ONES FOR WOMEN WITH CHRONIC INFLAMMATORY CONDITIONS. FOR OVER FIVE YEARS, UCB LED INITIATIVES FOCUSEDO PLANNING, PREGNANCY IS AND IMMUNOLOGICAL DISEASES TO HELP ADDRESS AND BRIDGE GAPS AROUND DISEASES SUCH AS RHEUMATOID ARTHRITIS, CROHN'S DISEASE AND LUPUS. WE ENGAGE WITH PATIENTS TO BETTER UNDERSTANDS THEIR CLINICAL, SOCIAL, ECONOMICAL AND PERSONAL NEEDS. FOR WOMEN LIVING WITH THESE CONDITIONS, THE PROSPECT OF PLANNING TO HAVE CHILDREN ARE EXPANDING THEIR FAMILIES, RAISES QUESTION BUSY THEIR HEALTH AND MEDICINES USED FOR THEIR CARE. THEY HAVE UNIQUE NEEDS TO UNDERSTAND SUCH AS IF AND HOW THE DISEASE MAY EFFECT THEIR ABILITY TO HAVE CHILDREN INCLUDING INFERTILITY. HOW PREGNANCY MAY EFFECT THEIR DISEASE AND HOW THEIR CONDITION MAY EFFECT THEIR PREGNANCY. AND WHETHER MEDICINES TAKEN BEFORE THEIR DISEASE, BEFORE, DURING OR AFTER PREGNANCY MAY EFFECT THEIR BABY. IN ADDITION, CONSIDERING THAT BREASTFEEDING HAS MULTIPLE BENEFITS FOR BABY AND MOM AND WITH ADVANCES IN SCIENCE AND KNOWLEDGE, CHOOSING TO BREASTFEED SHOULD NOT BE A TRADE OFF CHOICE BETWEEN THE HEALTH AND MOTHER OF THAT BABY. SCIENTIFIC ADVANCES ARE PREGNANCY OUTCOMES BEGIN WITH OPTIMIZING PREGNANCY HEALTH. THERE REMAINS A CLEAR NEED TO PROVIDE GUIDANCE FOR ADEQUATE TREATMENT DURING PREGNANCY AND LACTATION IN A PLANNER THAT DOES NOT ADVERSELY IMPACT THE INFANT. TO DATE, VERY LIMITED DATA ON THE EFFECTS OF DRUG ON THE FETUS AND INFANT ARE AVAILABLE. WE THAT ARE CONSISTENTLY FOR THE LAST DAY AND A HALF. THIS LACK OF DATA LEAVES BOTH PREGNANT AND LACTATING WOMEN AND TREATING PROVIDERS IN A DIFFICULT SITUATION WHEN CONSIDERING WHETHER TO INITIATE OR CONTINUE THERAPY AND CREATES AN IMPERATIVE TO GATHER MORE INFORMATION TO HELP INFORMED CARE AND POTENTIALLY UPDATE GUIDELINES. AS A LEADING BIOPHARMACEUTICAL RESEARCH COMPANY, WE ARE PROUD TO CONTRIBUTE TO RESEARCH, DEVELOPMENT AND EDUCATIONAL PROGRAMS IN THIS AREA WHICH HAVE AIMED TO INCREASE THE STANDARDS OF CARE. UCB LEADING THE WAY IN THE MANAGEMENT OF WOMEN WITH CHILD BEARING AGE THROUGH DISEASES THROUGH OUR RESEARCH INITIATIVES. WE RECOGNIZE MORE WORK NEEDS TO BE DONE AND LOOK FORWARD TO COLLABORATING WITH THIS TASK FORCE AND OTHERS ACROSS THEY ENTIRE HEALTH CARE ECOTOSS CONTINUE THAT WORK. WE RECENTLY COMPLETED TWO COMPREHENSIVE STUDIES TO OBTAIN MORE ROBUST DATA ON THE POTENTIAL TRANSFER OF DRUGS DURING PREGNANCY LACTATION. THESE RESULTS HAVE BEEN SUBMITTED TO THE FDA IS A GOAL THAT THE REVISED LABELING WILL INCLUDE IMPORTANT INFORMATION THAT CAN BETTER INFORM THE CARE. BEYOND THESE ADVANCES UCB IS COMMITTED TO WORKING WITH PATIENTS AND THEIR HEALTH-CARE PROVIDERS AND THE FEDERAL GOVERNMENT TO CREATE CLINICAL PATHWAYS AND EDUCATIONAL MATERIALS TO ENSURE THAT WOMEN OF CHILD BEARING AGE HAVE THE RIGHT INFORMATION TO MAKE THE RIGHT DECISION FOR THEIR FAMILY PLANNING CONSIDERATIONS. WE LOOK FORWARD TO WORKING IN COLLABORATION WITH ALL THE STAKEHOLDERS. SPECIFICALLY AS WE KICK OFF OUR WORK HERE, WE HOPE THAT THESE FOLLOWING RECOMMENDATIONS WILL BE CONSIDERED FOR THE FINAL REPORT OF THE TASK FORCE: A STANDARD FOR ALL PREGNANCY DATA WHICH SHOULD INCLUDE REAL-WORLD EVIDENCE THAT HAS BEEN AGREED UPON BY THE FEDERAL AGENCIES, MEDICAL SOCIETIES AND INDUSTRY, THAT WOULD BE RELEASED IN A SCIENTIFIC FORUM. WE HOPE THAT THERE IS ENHANCED RESEARCH SUCH AS REGISTRIES WHICH WE TALKED ABOUT, TO REALLY UNDERSTAND THE IMPACT OF UNTREATED DISEASE ON PREGNANCY OUTCOMES. A NEED TO DEVELOP A HARMONIZED MATRIX FOR WOMEN OF CHILD BEARING AGE IN TERMS OF COLLECTING, INTERPRETING AND ANALYZING THE REAL-WORLD EVIDENCE MORE EFFECTIVELY FOR THIS SEGMENT TO MAKE INFORMED DECISIONS. A DATABASE THAT IS DISEASE SPECIFIC AS WELL AS DRUG SPECIFIC FOR PREGNANCY AND LACTATION AND REALLY A SHIFT TO DATA SHARING TRANSPARENCY AND MORE RESEARCH TO ENABLE INFORMED DECISION MAKING BY WOMEN GUIDED BY THEIR PROVIDERS. OUR HOPE IS THAT THIS TASK FORCE WILL RAISE A BETTER STANDARD ACROSS THERAPEUTIC AREAS TO ADVANCE RESEARCH AND KNOWLEDGE TO PREGNANT AND LACTATING WOMEN. TO ENSURE THAT PATIENTS AND PROVIDERS CAN ULTIMATELY MAKE MORE INFORMED DECISIONS ON PREGNANCY AND PLANNING AND CARE MANAGEMENT BEFORE, DURING AND AFTER PREGNANCY, ENABLING OPTIMAL HEALTH FOR OUTCOMES FOR THE MOTHER AND THE BABY. THANK YOU. [ APPLAUSE ] >> DR. SPONG: I WANT TO THANK THE PANELISTS FOR YOUR THOUGHTS AND COMMENTS. THERE IS SO MUCH WORK FOR US TO DO. AND IT'S JUST WONDERFUL THAT THERE IS SUCH PASSION IN THE ROOM AND THAT WE ARE GOING TO BE ABLE TO ADDRESS OVER MANY, MANY MEETINGS, MANY OF THESE DIFFERENT TOPICS. I WOULD LIKE TO TAKE THE OPPORTUNITY NOW TO OPEN UP TO THE ROOM FOR DISCUSSION. I WILL ASK THAT WHEN YOU SPEAK, PLEASE SPEAK IS INTO A MICROPHONE AND PLEASE IDENTIFY YOURSELF SO IT'S EASY BECAUSE THERE ARE PEOPLE LISTENING TO US VIRTUALLY. THIS PANEL IS REALLY TO HELP US IDENTIFY RECOMMENDATIONS. SO IT'S WITHIN THE IDENTIFICATION OF FEDERAL ACTIVITIES, THE RECOMMENDATIONS FOR THE COORDINATION OF AND COLLABORATION ON RESEARCH RELATED TO PREGNANT WOMEN AND LACTATING WOMEN. AND WE HEARD A NUMBER OF EXAMPLES OF CURRENT ONGOING COLLABORATIONS AND COORDINATION. WHAT I'D LIKE TO HAVE AS PART OF THE DISCUSSION IS, WHAT ARE SOME RECOMMENDATIONS, WHAT ARE SOME STUDENTS WHAT ARE SOME POTENTIAL CHALLENGES TO THOSE COORDINATION AND COLLABORATION? DR. BIANCHI? >> DR. BIANCHI: SO I'D LIKE TO THANK GENE FOR THE SHOUT OUTS TO THE NETWORKS THAT ARE SPONSORED AND FACILITATED BY NICHD. THAT COMES AT A COST. SO WE HAVE A 1.4 BILLION DOLLAR ANNUAL BUDGET RIGHT NOW AND 80% APPROXIMATELY GOES TO THE EXTRAMURAL PROGRAMS. AND OF THAT, ABOUT 16% GOES TO THE NETWORKS. SO WE SPEND A CONSIDERABLE AMOUNT, MUCH MORE SO THAN OTHER INSTITUTES, ON THESE NETWORKS AND WE DO THAT BECAUSE WE THINK IT'S EXTREMELY IMPORTANT. BUT, I THINK ONE OF THE OPPORTUNITIES WE MIGHT HAVE IS TO INVESTIGATE HOW WE CAN USE THE INFRASTRUCTURE AND PARTNER WITH INDUSTRY TO ACCOMPLISH MUTUAL GOALS. AND THAT IS SOMETHING IS THAT OTHER INSTITUTES DO. HISTORICALLY, NICHD HAS NOT DONE THAT BUT I WOULD PUT ON THE TABLE AS A POTENTIAL OPPORTUNITY TO WORK TOGETHER TO GET MORE OF THIS RESEARCH DONE. ED. >> VICKI PEMBERTON FROM NHLBI. I'D LIKE TO ADD TO THAT. ONE ARE ONE INSTITUTE THAT THE DOES LEVERAGE OUR RELATIONSHIPS WITH INDUSTRY WITHIN OUR NETWORKS, PARTICULARLY THE PEDIATRIC HEART NETWORK. THE OTHER THING THAT I WANTED TO SAY, WE DID AN INTERESTING ANALYSIS OF OUR CARDIOVASCULAR STUDIES AND WE LOOKED AT INTERVENTIONAL STUDIES TO SEE IF WE COULD UNDERSTAND WHAT WERE SOME OF THE PREDICTORS OF SUCCESS. AND I HAVE TO SAY, SUCCESS WAS DEFINED PRETTY LIMITED. WE JUST REALLY LOOKED OR FOCUSED ON PATIENT RECRUITMENT. DID THE STUDY ATTAIN THE SAMPLE SIZE THAT THE INVESTIGATORS PROPOSED? DID THEY FINISH WITHIN THE TIME THAT THEY HAD ORIGINALLY PROPOSED? AND WE FOUND THAT NETWORK STUDIES WERE ONE OF THE VERY FEW PREDICTORS OF SUCCESS IN THAT REGARD. AND I THINK THAT INDUSTRY, THIS IS VERY MUCH IN LINE WITH WHAT INDUSTRY WANTS. SO, I WOULD HIGHLY RECOMMEND THAT WE THINK ABOUT THE INTEGRATION OF INDUSTRY AND THE ESTABLISHED NETWORKS. >> THANK YOU FOR YOUR COMMENTS BECAUSE I THINK YOU'RE QUITE RIGHT. I'M NOT SO CONVINCED THAT IT HAS TO BE A NETWORK BUT I DO THINK THAT IN TERMS OF THE ABILITY FOR ESPECIALLY INNOVATOR DRUG TRIALS TO BE SUCCESSFUL, THE ABILITY TO TAP INTO A NETWORK OF INDIVIDUALS WHO UNDERSTAND THE STRIPIGENCEY OF HOW OUR STUDIES ARE CONDUCTED, AND THE FACT THAT WE DO, EVEN THOUGH IT TAKES ABOUT NINE YEARS ON EVENING GET A PRODUCT FROM BENCH TO THE MARKET THROUGH APPROVAL, OUR STUDIES ARE REALLY QUICK STUDIES FOR THE MOST PART. EFFICIENCY IS KEY. AND IF WE CAN'T HAVE EFFICIENCY IN THE CONTRACTING PROCESS F WE CAN'T HAVE EFFICIENCY IN THE RECRUITMENT PROCESS, IF WE CAN'T HAVE EFFICIENCY IS IN THE ANALYTICS COMPONENT, IT MAKES IT VERY DIFFICULT FOR US TO BE SUCCESSFUL WITH OUR PROGRAMS BEING ABLE TO ULTIMATELY LEAD TO INFORMATION THAT CAN GET INTO A LABEL. SO I THINK YOU'RE QUITE ON THE MARK. >> MY LAST COMMENT WAS REALLY ABOUT TRANSPARENCY. AND AGAIN, I THINK AS UCB, WE WOULD LOVE TO SHARE AS MUCH INFORMATION AS WE HAVE WITH THIS TASK FORCE, ESPECIALLY WE DO A LOT OF RESEARCH ON THE EQUAL DATIVE SIDE ABOUT WHERE PATIENTS ARE GETTING THIS INFORMATION, WHERE PROVIDERS ARE GOING. COORDINATED CARE BETWEEN THE SPECIALTIES AND PHYSICIANS SO ADD WE MOVE FORWARD THAT'S SOMETHING WE WOULD LIKE TO BRING TO THE TABLE OF SHARING WHAT THE INFORMATION IS THAT WE ARE GATHERING. >> NATIONAL COALITION MATERNAL AND MENTAL HEALTH. I HAVE A COMMENTARY OR JUST POSE SOMETHING FOOD FOR THOUGHT. GOING BACK TO WHAT SUSAN GIVENS STATED WITH THIS NEW THING CALLED THE INTERNET THAT EVERYONE USES ALL DAY LONG, ESPECIALLY SELF DIAGNOSIS WHAT IS HAPPENING. THIS NEW INTERNET THING AND THIS OTHER THING CALLED TWITTER ALSO IS BEING USED BY A MULTITUDE OF PEOPLES IN GATHERING INFORMATION FROM A PATIENT ADVOCACY STANDPOINT. BACK IN BOSTON THEY ARE UTILIZING CLINICALTRIALS.GOV AND PUTTING ON TWITTER CHATS AND FACEBOOK AND STUFF TO GET FOLKS TO UNDERSTAND GUESS WHAT? THERE IS FDA FAST TRACK AND YOU MIGHT WANT TO GET INTO THESE CLINICAL TRIALS. AND THIS ISN'T ON TO PUT YOU IN AS A GUINEA PIG BUT TO HELP DEAL WITH THAT SPECIFIC 27-PERSON POPULATION YOU CITED ET CETERA. AND WHAT IS HAPPENING AND PERHAPS THIS IS A GENERATIONAL THING OF WHICH I CANNOT SPEAK TO BECAUSE I'M NOT A MILLENNIAL. BUT I DO BELIEVE THERE IS OR SEEMS TO BE A CHANGE IN ATTITUDE OF THE NEXT GENERATION COMING UP THAT I'M MUCH MORE WILLING TO STEP UP TO THE PLATE AND SAY, HEY, I WANT TO BE -- I WANT TO GET OR I DON'T MIND IF I'M PREGNANT WITH THIS CLINICAL TRIAL. I GUESS MY POINT IS, THERE IS INFORMATION GOING TO AT LIGHTNING SPEED AROUND SOMETHING THAT IS AS SLOW AS THE DAY IS LONG. AND I ALSO WANT TO SAY IS THAT THERE IS FDA FAST TRACK NOW AND I ASSUME IS THAT WILL CHANGE THINGS AND HOW THEY ARE PROCESSED AS WELL. SO THANK YOU. S. >> I WOULD JUST COMMENT ON A COUPLE OF THINGS THAT YOU SAID, JAMIE. THIS GENERATION OF GENERATION-Y Z IN THEIR REPRODUCTIVE YEARS NOW ARE ORAL ACCESSING THEIR HEALTH CARE THROUGH PORTALS. THEY ARE INPUTTING THEIR INFORMATION ON LINE. THEY ARE DIGITAL NATIVES. THEY ARE COMFORTABLE IN THAT ENVIRONMENT. WE ARE NOT. AND THAT IS AN OPPORTUNITY FOR US TO REALLY HARNESS AN AMAZING AMOUNT OF DATA. IT'S NOT LIMITED BY THE BOUNDARIES OF THE U.S. I MEAN, THIS IS GLOBAL DATA COLLECTION THAT COULD HAPPEN. IN THE SOCIAL MEDIA AND DIGITAL FORMATS. AND I WANT TO GO BACK JUST A SECOND TO THE COLLABORATION OPPORTUNITIES AMONG THE FEDERAL AGENCIES. OUR OFFICE CREATED A COUPLE WAS HOURS OF ON LINE TRAINING ON INCREASING DIVERSE WOMEN IN CLINICAL TRIALS. WITH ACRP. AND WE -- AND SO GOING THROUGH ALL OF THAT LITERATURE AND DATA ABOUT BARRIERS TO ENROLLING WOMEN, ONE OF THE THINGS THAT WE KEEP SAYING IS, THINK DIVERSITY FIRST. IF YOU THINK DIVERSITY LAST, IT WILL NOT HAPPEN. SO I WOULD SAY FOR US, THINK COLLABORATION FIRST. EARLY IN OUR INITIATIVES, WE SHOULD BE THINKING ABOUT OUR COLLEAGUES ACROSS THE FEDERAL LANDSCAPE AND HOW WE CAN BRING IN STAKEHOLDERS AND HAVE CONVERSATIONS AT THE TABLE EARLY IN THE PIPELINE. AND ALL OF THESE NETWORKS AND COLLABORATIONS AND THING THAT WE HEARD ABOUT, A CENTRALIZED PLACE WHERE WE ARE LISTING OUR ACTIVITIES ON PREGNANCY AND LACTATION. AND I DON'T MEAN FOR IT TO BE LABORIOUS OR A HUGE RESOURCE OR INTENSIVE, BUT SOMEWHERE THAT ACTUALLY LOGS WHAT WE ARE DOING AND WHO IS THE LEAD AGENCY? WHAT IS THE INITIATIVE? IS IT HELPFUL COMMUNICATIONING? BASIC TRANSLATIONAL CLINICAL TRIAL RESEARCH? BECAUSE WE HAVE COLLECTED A HUGE AMOUNT OF DATA JUST HERE IN THE DAY AND A HALF BUT WHERE IS IT GOING TO GO? AND HOW DO WE ACCESS THAT? AND I THINK THAT IS SAY REAL TANGIBLE WE COULD DO. >> JOE FROM N COG. WANTED TO PIGGYBACK ON TO THE COMMENTS MADE BY MY NHLBI COLLEAGUE HERE. SO N SCATS ONE OF THE NEWEST CENTERS HERE AT THE NIH. IT'S ABOUT BARELY SIX YEARS OLD NOW. AND WE HAVE SOME GOOD MODELS FOR COLLABORATING WITH INDUSTRY. SO I CAN MENTION A COUPLE OF PROGRAMS. A NEW THERAPEUTICS PROGRAM. THE LEAD THERE IS CHRIS COLVIS IT'S LOOKING OR DISCOVERY NEW THERAPEUTICS FOR EXISTING MOLECULES AND AIMING TO IMPROVE THE PROCESS OF DEVELOPING NEW TREATMENTS AND CURES FOR DISEASES BY FINDING NEW USES FOR EXISTING THERAPIES. SO DE-RISKING THOSE THERAPIES. AND THERE ARE SEVERAL COMPANIES THAT HAVE SIGNED ON TO THIS PROGRAM AND THEIR MOU IS IN PLACE THAT I THINK COULD BE USEFUL FOR THIS GROUP. IN ADDITION, WE HELD FOCUS GROUPS WITH THE DRUG INFORMATION ASSOCIATION AND WE KNOW THAT INDUSTRY IS VERY MUCH INTERESTED IN COLLABORATING WITH US BUT THEIR CULTURAL DIFFERENCES BETWEEN ACADEMIA AND INDUSTRY JUST IS GETTING TO TALKING THE SAME LANGUAGE. BUT THEY ARE LOOKING FOR TALENT. FOR OPPORTUNITIES. AND I THINK NCATS COULD HELP FACILITATE THIS BECAUSE WE HAVE THE LOUs IN PLACE. SO WE STARTED ALSO A PROGRAM WITH ELI LILLY THAT I WAS INVOLVED WITH. WE LAUNCHED IT NOW WHERE WE HAVE TRAINEES FROM OUR LARGE CLINICAL AND TRANSLATIONAL SCIENCE AWARDS GOING TO INDUSTRY AND LEARNING ABOUT HOW INDUSTRY DOES WORK, HOW INDUSTRY GETS PRODUCTS TO THE PATIENTS. THINGS THAT THEY DON'T OFTEN LEARN IN ACADEMIA. SO RIGHT NOW WE HAVE A PILOT THAT WAS LAUNCHED LAST YEAR. WE HAVE TWO PARTICIPANTS FROM THE CLINICAL AND TRANSLATIONAL SCIENCE AWARDS THAT WENT FOR SIX MONTHS AND THEY SAID IT WAS REALLY INVALUABLE TO THEIR CAREER TRAJECTORIES. THIS YEAR WE HAVE ANOTHER COHORT GOING. IT'S A START. WE ARE HAVING MEETINGS WITH OTHER ENTITIES. SO NCATS IS VERY MUCH OPEN TO PARTNERING WITH INDUSTRY. WE ALSO HAVE THE TRIAL INNOVATION NETWORK WHICH MANY OF YOU ARE FAMILIAR WITH. IT'S NEW. IT'S ONLY BEEN A YEAR IN PLACE BUT WE ARE LOOKING TO ALSO PARTNER WITH INDUSTRY AND ACADEMIA THROUGH THIS NETWORK. THEY ARE STANDARDIZED CONTRACTS IN PLACE. INDUSTRY HAS NOT BEEN BROUGHT IN THAT THE POINT AND INVESTIGATORS HAVE TO FIND AN IC THAT IS WILLING TO TAKE THEM ON FIRST AND THEN NCATS HELPS TO PROVIDE THE INFRASTRUCTURE TO DESIGN AND HELP WITH THE TOOLS AND METHODOLOGIES THEY NEED TO STREAMLINE THE TRIALS AND USE A SINGLE IRB AND STREAMLINE PROCESSES. I THINK THERE IS AN OPPORTUNITY HERE. IF WE DECIDE TO TAKE THIS FORWARD TO PARTNER WITH NCATS TO DO THESE STUDIES AND MAKE IT HAPPEN. >> I AGREE ENTIRELY WITH WHAT YOU'RE SAYING AND YOU KNOWLEDGE IT'S ONE OF THE REALLY ENCOURAGING THINGS IS THAT THERE HAVE BEEN MANY OF THESE ROTATIONS IN AND OUT OF THE INDUSTRY AND I THINK IT IS HELPING TO FACILITATE THAT COMMON LANGUAGE AS YOU WERE SAYING. SO I AGREE. I THINK THERE IS SOME VERY UNIQUE AND HOPEFULLY MORE OPPORTUNITY DOWN THE ROAD FOR BETTER COLLABORATION AND I WANTED TO QUICKLY JUMP ON TO SOMETHING ABOUT THE REGISTRIES AND ONE OF THE THINGS THAT I THINK WE HAVE TO POTENTIALLY CONSIDER HERE IS THAT THERE ARE MULTIPLE DIFFERENT TYPES OF REGISTRIES. COMPANIES WORK INDIVIDUALLY ON A PRODUCT. AND FROM AN INDUSTRY PERSPECTIVE, FOR US TO BE REALLY SUCCESSFUL, IN THE PREGNANCY AND LACTATION SPACE, WE NEED TO NOT BE DRUG-CENTRIC IN THE WAY WE DESIGN OUR REGISTRIES. AND I THINK THERE HAS BEEN SOME GOOD SUCCESS. I KNOW IN THE ANTIEPILEPTICS FOR PREGNANCY REGISTRIES BUT ONE OF THE THINGS WE CAN THINK ABOUT IS AN OPPORTUNITY FOR THE TASK AS FAR AS HOW-TO GUIDE AND MAKE RECOMMENDATIONS MOVING FORWARDS ESPECIALLY THINKING ABOUT HEW TO BEST COLLECT INFORMATION IN THE POST-MARKET SETTING TO FOCUS ON THE DISEASE-FOCUSED REGISTRY. THIS IS GOING TO BE OUR BEST OPPORTUNITIES TOW CAPTURE INFORMATION RATHER THAN BEING DRUG-CENTRIC WHICH WILL MAKE IT DIFFICULT FOR INFORMATION TO BE COLLECTED AND FRANKLY IS NOT NECESSARILY THE BEST WAY TO CAPTURE THE INFORMATION FOR THE PATIENTS. >> CHRISTINA, I'LL FOLLOW-UP ON THAT BECAUSE JUST TO CLARIFY FOR THOSE OF YOU, WHO MAY KNOW BUT SOME MAY NOT, THE FDA EACH REGISTRY IS OWNED BY THE SPONSOR THAT CREATES THE REGISTRY. EITHER THE REGISTRY IS MANDATED AS PART OF THE POST-MARKETING SAFETY ANALYSIS AND DATA COLLECTION OR IT'S VOLUNTARY ON THE PART OF THE SPONSOR. WE ARE NOT -- DON'T CREATE THE PORTAL BUT I UNDERSTAND THAT IT IS ARDUOUS. I HEARD THAT. AND THE OFFICE OF WOMEN'S HEALTH FUNDED A STUDY LOOKING AT ALL OF THE CURRENT REGISTRIES A COUPLE OF YEARS AGO AND THE -- IT WAS DISPARATE DATA REPORTING. SO I CAN'T REALLY COMBINE REGISTRIES. AND I THINK THAT ONE OF THE POINTS WE COULD BRING OUT, SPECIFICALLY BECAUSE REGISTRIES HAVE BEEN MENTIONED SEVERAL TIMES. AS HUGE POTENTIAL. SOME UNIFORMITY ACROSS THAT AS CHRISTINA WAS SAYING AND HOW WE CAN MAKE IT LESS ARDUOUS FOR PRACTITIONERS TO ENROLL PATIENTS. SO PATIENTS ENTERING INTO A REGISTRY IS VOLUNTARY ON THE PART OF THE PATIENT. BUT IF YOU TALK TO SOME CLINICIANS, MANY DON'T KNOW ABOUT THE PREGNANCY REGISTRIES. SO AGAIN AS SUSAN WAS SAYING, ABOUT HEALTH COMMUNICATION F WE DO GREAT WORK BUT WE NEVER CONNECT IT TO THE PRACTITIONER OR THE RESEARCHER OR THE PROVIDER AND ON TO THE PATIENT, WHAT WE CALL THE VALLEY OF DEATH IN THE RESEARCH FIELD. BUT IT REALLY IS IT'S REALLY TRANSLATING THAT TO KNOWLEDGE AND BEHAVIORAL CHANGE, WHICH NEEDS TO HAPPEN. >> THAT'S WELL UNDERSTOOD IT'S AN OPPORTUNITY HOW TO WORK TOGETHER AS STAKEHOLDERS TO IDENTIFY THESE COLLABORATIVE MEANS OF BEING ABLE TO SET THEM UP. AND THEN I GUESS THE OTHER QUESTION THAT I HAVE IS, WE ARE TALKING WE ARE COMING THAT THE FROM MANY DIFFERENT PER SUSPECT I WAS AND I PRESENTED FROM AN INNOVATOR PERSPECTIVE. SO WE ALSO HAVE TO THINK ABOUT HOW BOAST FACILITATE THAT NEW DRUG DEVELOPMENT. WE DON'T WANT WOMEN TO ALWAYS BE THE TEST MARKET CONSIDERATION TO DEVELOPMENT. WE WANT WOMEN TO BE FROM THE BENCH TO REGISTRATION, CONSIDERATION FOR DEVELOPMENT, AND SO, I REALLY HOPE IN THE TASK FORCE THAT WE WON'T JUST BE COMING THAT THE FROM THE POST SIDE. WE REALLY NEED TO UNDERSTAND HOW BOAST FACILITATE THE RESEARCH FROM THE BENCH MOVING FORWARD. >> I'D LIKE TO MAKE A COUPLE OF COMMENTS AND ASK SOME QUESTIONS. ONE OF THE OTHER HATS THAT I WEAR IS ON THE SCIENTIFIC ADVISORY BOARD FOR THE RIBOVIRUS REGISTRY. AND WE HAVE EXPERIENCED AN INTERESTING EVOLUTION OBVIOUSLY. OUR RIBOVI RIN HAS DISAPPEARED FROM THE THERAPY FOR HEPATITIS C BEING OVER TAKEN OF COURSE BY THE PROTEASE INHIBITORS AND THE OBVIOUS QUESTION CAME UP, SHOULD WE TRANSITION FROM A SINGLE DRUG, RIBOVINE REGISTRY, TO A HEPATITIS C TREATMENT REGISTRY? NOW RIBOVINE IS IN A LITTLE BIT OF A DIFFERENT SITUATION BECAUSE IT'S NON PROPRIETARY ANYMORE AND OFF PATENT AND A HALF DOZEN COMPANY OR SO IS THAT MAKE IT AND THE SCIENTIFIC OR EN DESERVE SUPPORTED BY ALL OF THOSE PHARMACEUTICAL COMPANIES TOGETHER -- ENDEAVOR. IT'S A COLLABORATIVE ARRANGEMENT DIFFERENT FROM A SINGLE DRUG AND SINGLE COMPANY. SO IT IS AN INTERESTING AND SOMEWHAT DIFFERENT KIND OF SITUATION. WE HAVEN'T GOTTEN A CONSENSUS YET AS TO WHETHER WE ARE GOING TO GO FROM A SINGLE DRUG TO A DISEASE, AND LOOK AT OTHER DRUGS. BUT THE POST MARKETING SURVEILLANCE WAS PART OF THE REQUIREMENTS FOR THE RIBOVINE. AND THE OTHER THING I WILL MENTION AS REVIEWING ALL OF THESE SAFETY REPORTS THAT COME IN, THE QUALITY OF THE REPORTING THAT COMES IN IS HIGHLY VARIABLE, TO SAY THE LEAST. AND IT'S A BIT OF A CHALLENGE SOMETIMES TO UNSCRAMBLE THE EGGS. SO, THAT'S A COMMENT ABOUT REGISTRIES. I WOULD LIKE TO ASK TWO QUICK QUESTIONS. ONE FOR DR. CHRISTINA BUCCI-RECHTWEG. THE QUESTION THAT CAME UP FOR ME IMMEDIATELY, WAS WHY WERE THOSE PROTOCOLS SUSPENDED, WITHDRAWN, ET CETERA? THERE IS A LOT OF DIFFERENT POTENTIAL REASONS. ONE IS THEY COULDN'T RECRUIT ENOUGH SUBJECTS. TWO FEW UTILITY BECAUSE THERE WAS NOTHING THERE OR BECAUSE IT WAS A SAFETY ISSUE. SO I'LL GIVE YOU A KLANS TO ANSWER THE SECOND AND THEN DR. BIANCHI, I'D LIKED TO ASK YOU, ONE OF THE ISSUES THAT WE ARE FACING IS THAT OBSTETRICIANS CAN ONLY DO SO MUCH WITH WHAT THEY ARE GIVEN AND NOW 1-2% OF ALL PREGNANCIES IN THE UNITED STATES ARE THE RESULT OF ASSISTED REPRODUCTIVE TECHNOLOGIES. THERE IS A REPRODUCTIVE ENDOCRINE UNITED COOPERATIVE UNITED ANALOGOUS TO THE MATERNAL FETAL MEDICINE UNITS AND WHAT WHAT DEGREE IS THERE ANY PRIORITIZATION OF LOOKING AT THE OUTCOMES OF PREGNANCIES NOT JUST BEING ABLE TO GET WOMEN PREGNANT? SO A COUPLE OF THOUGHTS AND QUESTIONS. >> THANK YOU FOR THE GOOD QUESTION DR. GREEN. SO IN RUNNING THE ANALYSIS IN CLINICALTRIALS.GOV, THERE IS A TICK BOX FOR SELECTION OF WHY THE STUDY MIGHT BE TERMINATED OR WITHDRAWN OR SUSPENDED. SO IT'S HARD TO MAKE CLEAR WHAT THE REASONS MIGHT BE. NOW ONE OF THE THINGS I HAVE NOT DONE YET IS TO PULL THE 35 STUDIES. SO, IN CLINICALTRIALS.GOV NOT ONLY DO YOU HAVE TO POST THE STUDY PROTOCOL BUT WHEN THE STUDY IS COMPLETED REGARDLESS OF WHAT STAGE OF COMPLETION, YOU NEED TO POST THE OUTPUT. SO I WOULD HAVE TO GO BACK AND LOOK THROUGH ALL 35 OF THOSE STUDIES TO UNDERSTAND. AND MOST OF THE STUDY COMPLETION REPORTS THEY SHOULD HAVE THEIR REASON WHY IT'S JUST A MATTER EVER GOING THROUGH THE DATA. SO THAT'S THE NEXT STAGE. >> THAT MIGHT BE A PROJECT THAT DR. DEBORAH VARY IN MIGHT BE INTERESTED IN HELPING YOU WITH. SHE RUNS CLINICALTRIALS.GOV. >> STOW ANSWER YOUR QUESTION ABOUT OUTCOME STUDIES. THIS COMES UP WITH ALL OUR INTERVENTIONS NOT JUST ART, EXTREME PREMATURITY FOR EXAMPLE AND ET CETERA. I KNOW IT'S A PARTICULAR PASSION OF DR. SADY, THE LONG TERM OUTCOME STUDIES. I AGREE. LOOKING AT SILOS IN THE REPRODUCTIVE SPECTRUM REALLY GIVES YOU AN INCOMPLETE PICTURE BUT THE QUESTION IS, HOW DO YOU PAY FOR THAT? AND THEN ALSO HOW DO YOU TRACK INDIVIDUALS? AND IN OUR PARTICULAR U.S. HEALTH CARE SYSTEM IT'S A PROBLEM BECAUSE PEOPLE MOVE, PEOPLE CHANGE INSURANCES, THERE IS NO CENTRALIZED DATABASE. THAT IS WHY SO MANY STUDIES ARE BEING DONE IN EUROPE. BUT I TOTALLY AGREE WITH YOU THAT IT'S CRITICAL INFORMATION. SO I WOULD SUGGEST THAT THE WAY TO DO IT IS TO GET PATIENTS TO VOLUNTEER AS CITIZEN SCIENTISTS AND IN MY EXPERIENCE, I MEAN I SAID YESTERDAY THAT MY RESEARCH IS PRIMARILY BEEN IN PRENATAL GENETICS SCREENING. BUT I HAVE FOUND THAT PREGNANT WOMEN ARE EXTRAORDINARILY INTERESTED IN RESEARCH. THEY ARE INCREDIBLY COOPERATIVE. I THINK THEY ARE MUCH MORE LIKELY TO PARTICIPATE IN RESEARCH THAN OTHER POPULATIONS. SO WELL I THINK ONE OF OUR CHALLENGES IS HOW DO WE BRING THE PATIENT, CITIZEN SCIENTIST, THE VOICE OF THE PATIENT, INTO THIS WHOLE PROCESS? >> DIANE SCOTTS FROM THE UNIVERSITY OF PENNSYLVANIA AND CHILDREN'S HEALTH IN PHILADELPHIA. FOR ME, I THINK THE MOST STRIKING THING I'D LIKE TO COMMENT ON IS THE OVERWHELMING NEED FOR RESEARCH AND LACTATION. YOUR PRESENTATION, CHRISTINA, ABOUT THE DIRTH OF RESEARCH ON LACTATING WOMEN AND DRUG TRIALS, I MEAN WE SPEND A LOT OF TIME TALKING ABOUT THE PREGNANT WOMEN. BUT LIKE THE NEED IN LACTATION IS JUST SO GREAT. SO I THINK THAT THERE IS A HUGE OPPORTUNITY THERE AND I THINK THERE IS A TREMENDOUS OPPORTUNITY FOR THE PRIVATE PUBLIC OR COMPANY-DRIVEN -- THERE IS SAY LOT OF OPPORTUNITY. WE HAVE INCREASING BREASTFEEDING RATES AND INCREASING INTEREST IN BREASTFEEDING AND WOMEN WANT TO BE ABLE TO REACH THEIR PERSONAL BREASTFEEDING GOALS. THERE ARE BARRIERS. MILK SUPPLY IS A BARRIER. MOMS BEING GIVEN BAD INFORMATION ABOUT MEDICATION. SO I THINK TO ME, THE BIGGEST THING I HEARD FROM ALL OF THE PRESENTATIONS THIS MORNING IS THE NEED FOR LACTATING WOMEN TO BEADDRESSED. >> YOU'RE COMPLETELY CORRECT AND LAST YEAR, AND SOME OF YOU IN THE ROOM PROBABLY PARTICIPATED IN AN FDA HELD A TWO-DAY LACTATION WORKSHOP TRYING TO GET AT WHAT ARE WE GOING TO DO TO GENERATE THAT INFORMATION? YOU'RE RIGHT. THERE ARE WOMEN WHO ARE ON THERAPIES THEY CAN NOT STOP AND THEY WANT TO BREASTFEED. SO HOW DO WE BEST EVALUATE BREAST MILK? HOW CAN WE DO ANIMAL LACTATION STUDIES THAT MIGHT PROVIDE US INFORMATION WE NEED TO IF SILLITATE THIS. AND I DON'T THINK THE REPORT IS PUBLISHED YET BUT I KNOW IT'S BEEN SUBMITTED FROM THE FDA WORKSHOP. >> JUST TO TELL YOU A LITTLE BIT ABOUT OUR EXPERIENCE, WHICH I THINK IS A LITTLE BIT DIFFERENT TAN A LOT OF WHAT WE ARE DISCUSSING HERE. I AM A MEDICAL OFFICER THAT OVERSEES SAFETY FOR THE MICROBICIDE TRIALS NETWORK IN THE DIVISION OF AIDS T AND WE ARE DEVELOPING HIV PREVENTION PRODUCTS FOR HEALTHY, REPRODUCTIVE AGE WOMEN WHO GENERALLY CANNOT NEGOTIATE CONDOM USE AND MAY OR MAY NOT BE ON OTHER CONTRACEPTIVES TO USE. AND SO CLEARLY PREGNANCY IS GOING TO BE AN ISSUE. AS A PART OF THE DEVELOPMENT PROCESS, SO THESE ARE UNLICENSED DRUGS IN DEVELOPMENT. AND IN OUR DISCUSSIONS WITH REGULATORY BODIES, BOTH IN THE UNITED STATES AND ELSEWHERE, ONE OF THEIR BIGGEST QUESTIONS IS WHAT EFFECT IS THIS GOING TO HAVE ON PREGNANCY? AND THERE IS A NEED TO HAVE THAT INFORMATION PRIOR TO LICENSURE. NOT POST-LICENSURE. BECAUSE WOMEN WILL USE THESE PRODUCTS DURING PREGNANCY KNOWING LEOR UNKNOWINGLY. SO, WITH REGARD TO THE ISSUE OF REGISTRIES, ONE OF THE THINGS THAT WAS REQUESTED BY THE FDA WAS TO FOLLOW ALL WOMEN WHO HAVE BECOME PREGNANT DURING OUR CLINICAL TRIALS OR PHASE III TRIALS. WE HAVE DISCONTINUED THEM FROM PRODUCT USE ONCE WE DIAGNOSIS THE PREGNANCY BUT TO FOLLOW THEM THROUGHOUT THEIR PREGNANCY AND FOLLOW THEIR INFANTS TO ONE YEAR OF AGE. GRANTED CERTAINLY YOU COULD ARGUE WHETHER ONE YEAR IS LONG ENOUGH BUT FEASIBILITY WISE THAT IS WHAT WE AGREED UPON. SO, WE CREATED SOMEWHAT OF AN ACTIVE REGISTRY. IT'S NOT LIKE THESE OTHER REGISTRIES REALLY WHERE THE WOMEN ARE FOLLOWED AT APPOINTMENTS AND PLACE WHERE IS WOMEN DON'T ROUTINELY GET ULTRASOUND. WE PROVIDE AN ULTRASOUND DURING THE PREGNANCY. WE PROVIDE EXAMS OF THE INFANT AND WE HAVE GENETICS CONSULT WOULDN'T WE USURY MOATLY VIA PHOTOGRAPHS TO PROVIDE GENETIC DIAGNOSIS FROM THE INFANTS. OLE THESE TRIALS ARE CONDUCTED IN AFRICA AND ALTHOUGH WE DO HAVE PURPOSEFUL STUDIES OF PRODUCTS AND PREGNANCY IN THE UNITED STATES FOR WHICH WE ALSO USE THE SAME REGULATORY -- THE SAME MECHANISM. WE ARE DOING PURPOSEFUL TRIALS OF UNLICENSED PRODUCTS IN PREGNANT AND LACTATING WOMEN, WHICH IS A LITTLE PAST THE EDGE OF WHERE A LOT OF THIS IS. SOME PEOPLE MIGHT THINK WE ARE OVER THE EDGE. BUT, IT HAS BEEN VERY IMPORTANT BOTH THE FDA, EMA, THE SOUTH AFRICAN MEDICINE CONTROL COUNCIL HAVE ALL WANTED THIS INFORMATION AND THEY WANT IT NOW NOT LATER. AND SO IT HAS FORCED US TO GO THIS WAY FOR THE RING, A PRODUCT CURRENTLY BEING REVIEWED BY THE EMA FOR LICENSURE. WE ARE GOING TO START A LARGE PREGNANCY TRIAL, HOPEFULLY ABOUT A YEAR FROM NOW IN SEVERAL AFRICAN COUNTRIES, WITH PURPOSEFUL USE. IT WILL BE WHAT WE CALL A ROLLBACK STUDY WHERE WE START NEAR-TERM AND ROLLBACK THE PREGNANCY. AND TO GET INFORMATION, SAFETY INFORMATION ON THIS PRODUCT EARLY, SO THOSE CONVERSATIONS ARE HAPPYING IN SOME SPACES. I THINK IT'S LIMITED SPACES RIGHT NOW. AND WE CAN TALK ABOUT HOW TO MAKE MORE SPACES WHERE WE ARE HAVING THESE CONVERSATIONS EARLY. BUT, JUST TO LET YOU KNOW, IT IS HAPPENING. AND BY THE WAY, THE FLOAT TO THAT IS WE PROBABLY SHOULD INCLUDE PREVENTION AND NOT JUST TREATMENT IN OUR THERAPIES. >> I HAVE A QUESTION FOR THE INDUSTRY COLLEAGUES. YOU MENTIONED IN YOUR TALK THAT WE NEED TO START ENROLLING -- START THINKING PREGNANCY FROM THE DESIGN PROCESS, NOT THE POST LICENSURE AND NOT -- AND EVERYBODY IN THE ROOM WAS HEAD NODDING. GREAT. SO I THINK WE ALL AGREE. THE QUESTION IS, HOW DO WE DO THAT? IS DO YOU INCENTIVIZE INDUSTRY TO DO IT SIMILAR TO THE PEDIATRIC GROUPS? DO YOU INVENT VISE INDUSTRY? HOW DO YOU CONVINCE PEOPLE TO INCORPORATE PREGNANT WOMEN FROM THE DESIGN PROCESS ONWARDS? >> THERE ARE ANY ATTORNEYS IN THE ROOM? [ LAUGHS ] THERE MAY SOMEBODY ON LINE. >> I'M SORRY. I KEEP PRESSING IT OFF INSTEAD OF ON REMEMBER THE LARGEST CHALLENGE IS NOT THE SCIENCE FACILITATING THE STUDIES. IT'S THE LEGAL AND ETHICAL CHALLENGES. AND UNTIL THOSE ARE ADEQUATELY ADDRESSED, WE ARE NOT LIKELY TO MAKE SIGNIFICANT PROGRESS MOVING FORWARD. AND I THINK WE NEED TO REALLY -- WE HAVE TO TAKE THIS HEAD ON AND CHALLENGE IT. WE MAY, IN THIS ROOM, DESIGN THE PERFECT STUDY FOR INCLUSION OF PREGNANT WOMEN AND THEN WE'LL TAKE IT TO OUR IRBS AND THERE WILL BE NO PREGNANCY EXPERTS SITTING IN THAT ROOM AND THEY WILL NOT ALLOW US TO CONDUCT THAT STUDY IN THE INSTITUTION. SO OUR CHALLENGE IS NOT LARGELY THE SCIENCE IT'S NOT LARGELY THE OPPORTUNITY. IT'S THE COMPLEXITY OF THE ENVIRONMENT WITHIN WHICH WE ARE CONDUCTING OUR RESEARCH. AND WE HAVE TO ADDRESS THAT. AND IT CAN'T BE ADDRESSED SIMPLY FROM THE INDUSTRY PERSPECTIVE. WE HAVE TO DO IT FROM A MULTISTAKEHOLDER PERSPECTIVE AND INFLUENCE THE INDIVIDUALS WHO CAN BECOME THE BIG HURDLES TO UNDERSTAND WHY WE NEED TO PROTECT WOMEN THROUGH RESEARCH. AND NOT PROTECT THEM FROM RESEARCH. I THINK THIS IS THE CRITICAL PIECE THAT WE HAVE JUST NOT BEEN ABLE TO SUCCESSFULLY GET OUR HEADS AROUND AND THAT'S WHY I WANTED TO PUT UP WHAT EFGCP HAS DONE TO TAKE A POSITION STATEMENT TO SAY, WE HAVE TO DO THIS TO BE ABLE TO MOVE FORWARD. >> AND I WANT TO THANK YOU. I THINK AND JEANNE FOR BRINGING THIS UP. ALTHOUGH INDUSTRY HAS BEEN VERY WARMLY EMBRACED BY MANY RESEARCH VENUES AT NIH, AT NICHD, WE HAVE PARTNERED WITH RESEARCH A NUMBER OF EFFORTS BUT PREGNANCY HAS BEEN ONE THAT HAS BEEN VERY DIFFICULT NOT DUE TO LACK OF DESIRE ON ANYONE'S PART BUT I THINK REALLY IN THE ETHICAL AND THE LEGAL IMPLICATIONS OF DOING THAT FROM THE INDUSTRY STANDPOINT HAS BEEN A LIMITATION. AND WE HAVE HAD THE OPPORTUNITY IN SOME INSTANCES TO WORK WITH INDUSTRY BUT NOT TO THE DEGREE THAT YOU SEE IS IN OTHER FIELDS. WE DO HAVE AN ENTIRE TASK FORCE DEDICATED TO THE ETHICAL SIDE OF THIS QUESTION SO WE DON'T HAVE TO ANSWER THAT TODAY. WHICH I'M SURE IS A BIG CY OF RELIEF FOR EVERYONE. BUT IT IS ONE THAT WE ARE GOING TO HAVE TO AS A TASK FORCE, REALLY FIGURE OUT HOW WE WANT TO ADDRESS IT. THANK YOU. >> AND WOULD THE PROBLEM IS NOT LIMITED TO LIABILITY FOR INDUSTRY BUT EVEN WELL-REGARDED, FUNDED RESEARCHERS FOR THE NICHD HAVE BEEN TARGETS OF LEGAL AND ETHICAL ACTIONS AFTER TOTALLY ETHICAL STUDIES WERE COMPLETED AND HAD BEEN VETTED PRIOR TO THE BEGINNING BY MULTIPLE IRBs. IT IS SAY RUN AWAY TRAIN. >> AND SO, THIS IS BOB FROM ELI LILLY & CO. AND WOULD REINFORCE CHRISTINA'S COMMENTS WITH REGARD TO THE LEGAL AND ETHICAL. BUT, BEYOND THAT, I THINK THAT THERE IS A COUPLE OF OTHER THINGS IN THE THEME OF WHAT WE ARE TALKING ABOUT THIS MORNING THAT WE CAN FOCUS ON. NUMBER 1 IS, SIMILAR TO MY EXPERIENCES IN THE PEDIATRIC SPACE, BECAUSE HISTORICALLY INDUSTRY HAS NOT BEEN FOCUSED ON DEVELOPING PRODUCTS EXPLICITLY FOR OR STUDYING OUR PRODUCTS EXPLICITLY FOR USE IN CHILDREN SIMILAR IN PREGNANT AND LACTATING WOMEN; I THINK THERE IS LIMITED POCKETS OF EXPERTISE ACROSS THE INDUSTRY. SO THIS IS WHERE COLLABORATION WITH THE REAL EXPERTS AT THE FEDERAL AGENCIES IN ACADEMIA THAT ARE AT THE BEDSIDE ON A DAILY BASIS TREATING THESE PATIENTS, IS A REALLY KEY ELEMENT TO SUCCESS GOING FORWARD. THERE IS A LEARNING CURVE IN INDUSTRY THAT NEEDS TO BE OVERCOME WITH REGARD TO HOW WE DEVELOP DRUGS THAT MEET THESE PATIENT'S NEEDS. I THINK THAT AN ADVANTAGE, POTENTIALLY, AND SOMEONE MENTIONED IT SHALLER AND I MADE A COMMENT YESTERDAY, IS THAT UNLIKE THE PEDIATRIC CHALLENGE, THERE IS A HUGE SUBSTRATE HERE. WE HAVE 4 MILLION BIRTHS IN THE UNITED STATES ON AN ANNUAL BASIS AND BY ALL REGARDS WITH WHAT I HEARD OVER THE LAST COUPLE OF DAYS, A PATIENT POPULATION THAT IS WILLING TO BE ENGAGED IN THIS RESEARCH, AS OPPOSED TO PEDIATRIC ONCOLOGY WHERE WE MAY BE SEARCHING COAST-TO-COAST TO FIND ENOUGH PATIENTS TO ENROLL TO EXECUTE A CLINICAL TRIAL. SO FROM A LOGISTICAL STANDPOINT, I THINK THIS GROUP HAS SOME ADVANTAGES WITH REGARD TO THE SUBSTRATE THAT IS AVAILABLE TO DO THIS RESEARCH. SO IT IS REALLY MORE AROUND COORDINATING AND PASSING INFORMATION RIGHT TO THE KEY STAKEHOLDERS. AND I THINK THESE ARE TWO ELEMENTS, ASIDE FROM THINGS THAT I THINK WE CAN ADDRESS WITH THE FOLKS IN THE ROOM; BUT KNOWING THAT RISK OR CHALLENGE AROUND THE LEGAL AND ETHICAL PIECE IS SOMETHING THAT WE ARE GOING TO HAVE TO ADDRESS. >> AND I WOULD ONLY ADD ONE THING AND I THINK YOU'RE QUITE CORRECT, ROB. ONE OF THE THINGS I WOULD ADD SAID WHAT INDUSTRY IS VERY GOOD AT IS BEING NIMBLE. SO WITH AN OPPORTUNITY COMING UP, AND WE ARE GOING TO BE CONDUCTING MORE WORK IN PREGNANCY AND LACTATION, WE'LL BRING IN THE EXPERTISE. THE PROBLEM IS RIGHT NOW, I THINK DIANE AS YOU POINTED OUT, THERE IS NO WORK. SO THE EXPERCENTITIES IS NOT IN HOUSE. AND I THINK THAT THAT -- EXPERTISE -- THAT'S THE COMPONENT. >> JERRY FITS GERALD INTERNATIONAL LACTATION CONSULTANT ASSOCIATION. AS A LACTATION CONSULTANT I WOULD BE REMISS IF I DIDN'T MENTION THIS. BUT IN TERMS OF ETHICS OF RESEARCH AND LACTATION, WE SHOULD BE ADHERING TO THE CODE. AND THAT IS JUST A REMINDER. PROBABLY NOT AN ISSUE FOR MOST OF THE STUDIES THAT WOULD BE DONE IN LACTATION. BUT IT SHOULD BE THERE. IT SHOULD BE LOOKED AT. >> LINDA WITH VA. SO I'M GOING TO BRING THIS CONVERSATION A LITTLE BIT BACK TO THE COLLABORATION AND COORDINATION BECAUSE IT'S REALLY IMPRESSIVE IN TERMS OF WHAT ALL THE HHS AGENCIES ARE DOING IN TERMS OF COLLABORATION AND COORDINATION. AND PRIVATE SECTOR AND I REALIZE THAT VA IN TERMS OF WOMEN VETERANS IS A MUCH SMALLER NUMBER, BUT I THINK THERE IS AN OPPORTUNITY BOTH IN VA AND DOD. WE HAVE GREAT DATA SYSTEMS. DOD HAS BIGGER NUMBERS THAN WE DO AT VA BUT I THINK WE ARE MISSING AN OPPORTUNITY TO INCLUDE A POPULATION THAT I THINK WE ALL WOULD AGREE WE SHOULD BE ADDRESSING. AND INCLUDING AND AGAIN, VETERANS AND I'M SURE MILITARY SERVE OUR NATION THEY ARE WILLING, VERY WILLING PARTICIPANTS IN RESEARCH AS WELL. SO I WOULD LIKE TO SEE SOME ATTENTION PAID TO HOW WE CAN BETTER COLLABORATE. WE HAVE IN VA DOING A LOT WITH DIG DATA AND INFORMATICS. SO THERE ARE OPPORTUNITIES THERE. WE HAVE A REALLY VIBRANT HEALTH SERVICES RESEARCH COMMUNITY AS WELL AS CLINICAL TRIALS COMMUNITY. AND WE ALSO HAVE A WOMAN VETERAN'S RESEARCH PRACTICE CASE RESEARCH NETWORK THAT IS AT 65 DIFFERENT VA FACILITIES THROUGHOUT THE COUNTRY. SO I'D LIKE TO SEE -- I SEE HAVE YOU AN HMO NETWORK, KEISER PERSONALITY, I REALIZE THEY MAY HAVE BIGGER NUMBERS BUT I REALLY THINK THERE NEEDS TO BE MORE COLLABORATION. >> GOOD MORNING. GEORGE WITH WELL MATERNAL FETAL MEDICINE. THIS IS A GREAT DISCUSSION AND SO MANY POINTS WERE BROUGHT UP THAT I MAY HAVE MORE THAN ONE POINT TO ADDRESS. SO PLEASE BEAR WITH ME. I WANT TO TALK ABOUT THE NETWORK AND THE COLLABORATION BUT IN FULL DISCLOSURE, I'M A MEMBER OF SEVERAL OF THESE NETWORKS. SO BUT BEFORE YOU START SAYING, HE IS JUST TALKING ABOUT THE NETWORK BECAUSE HE IS PART OF THE NETWORK, LET ME REMIND YOU THAT THE NETWORKS ARE THE COOPERATIVE AGREEMENT. SO IN ADDITION TO THE COLLABORATION BETWEEN THE DIFFERENT ENTITIES, THERE IS ALSO THE DEPARTMENTS AND THE CENTERS IN THE NETWORK ARE ALSO PUTTING FUNDS INTO THE NETWORK LIKE MY CENTER, IT COST US TO BE IN THE NETWORK AS WELL AS OTHER CENTERS. SO YOU ASK WHY ARE YOU DOING IT THEN? WELL, WE ARE DOING IT BECAUSE WE FIRMLY BELIEVE THAT THIS IS THE BEST WAY TO DO CLINICAL TRIALS IN PREGNANCY. SO PEOPLE WILL SAY, WHY? WHY IS IT THE BEST WAY? WHY DON'T YOU DO IT INDEPENDENT INVESTIGATOR-INITIATED TRIALS? CLINICAL TRIALS IN PREGNANCY? THE PROBLEM IS, WE HEARD YESTERDAY IS THE CLINICAL TRIALS AND PREGNANCY ARE COMPLEX BECAUSE THEY REQUIRE LARGE NUMBER OF PATIENTS BECAUSE OF THE SMALL NUMBER OF OUTCOMES. ALSO IF YOU ARE GOING TO DO MEANINGFUL CLINICAL TRIALS WITH LONG-TERM FOLLOW-UP, TWO, 3, 5 YEARS AFTER BIRTH, ALL OF THESE CANNOT BE FIT INTO AN RO1, A TRADITIONAL RO1 CONSIDERING THE LIMIT ON THE YEARLY RO1 OF 500,000 OR 1.5 MILLION IF YOU CAN GET TO THAT. IT'S VORHARD TO FIT THAT TRIAL INTO THAT STRUCTURE OF A 5-YEAR, YEAR YOU CAN SPEND. THE OTHER REASON NETWORKS ARE VERY, VERY IMPORTANT AND USEFUL FOR CLINICAL TRIALS IS THE WAY THE TRIALS ARE DESIGNED AND TALKED ABOUT AND ARGUED AND CRITIQUED WITHIN THE NETWORK. NOT EVERY TRIAL FOR EVERY TRIAL THAT IS DONE IN THE NETWORK, THERE ARE ABOUT 10 THAT ARE PROPOSED IN THE NETWORK. AND EACH TRIAL BY THE TIME IT RISES TO THE TOP, IT HAS HAD MULTIPLE IN FRITZ A LOT OF STAKEHOLDERS. -- INPUTS -- UNLIKE A GROUP OF INVESTIGATORS. THIRDLY, THE NETWORK INCLUDES VERY IMPORTANT TO ME, AND I THINK DR. GREEN WOULD AGREE WITH THAT AS THE EDITOR OF THE NEW ENGLAND JOURNAL OF MEDICINE, THAT THE INDEPENDENT DATA COORDINATING CENTER IN THE NETWORKS IS VERY CRITICAL. PERSONALLY, I LOOK AT TRIALS. TRIALS ARE ALL LEVEL EVIDENCE BUT THERE ARE TWO DIFFERENT LEVEL A EVIDENCE. THE TRIALS THAT ARE RUN BY AN INDEPENDENT DATA COORDINATING CENTER AND THERE ARE TRIALS THAT ARE -- THAT DON'T HAVE AN INDEPENDENT DATA COORDINATING CENTER THAT ARE RUN BY THE INVESTIGATORS. THESE ARE TWO DIFFERENT TRIALS IN MY OPINION. SO MOVING ON TO ANOTHER POINT, WE FREQUENTLY IN OBSTETRICS HAVE PRIORITIZED NEONATAL OVER THE MATERNAL OR THE FETAL OVER ITS MATERNAL. AND MANY OF YOU HAVE HEARD RECENTLY ABOUT INCREASING MATERNAL MORALITY AND HOW MANY TRIALS ARE DONE FOR THE MOTHER RATHER THAN THE BABY. WHEN WE THINK OF PRE-TERM BIRTH, IT'S A BIG PROBLEM BUT WE ARE PRIORITIZING THE BABY. SO I HOPE THAT WHEN WE TALK ABOUT MEDICATIONS AND PREGNANCY, WE ARE TALKING ABOUT THE MOTHER AND MALL TERNAL OUTCOME. NOT JUST THE BABY. WE NEED TO FOLLOW THE CHILDREN, OF COURSE. BUT THEN WE ARE FOCUSING OUR INTERVENTION ON IMPROVING THE MATERNAL OUTCOME AND ULTIMATELY HOPEFULLY WILL IMPROVE THE FETAL OUTCOME. AND FINALLY, I WANT TO SAY THAT INDUSTRY IS WELCOMED IN THESE NETWORKS. WE HAVE DONE SEVERAL TRIALS WITH INDUSTRY. WE HAVE WORKED WITH NEOVENTA ON A FETAL MONITOR NOT LONG AGO. PUBLISHED IN THE NEW NEW ENGLAND JOURNAL OF MEDICINE. WE WORKED WITH THE NETWORK WITH WHOLOLOGYIC AND CURRENTLY DISCUSSING ANOTHER TRIAL WITH ANOTHER INDUSTRY. THE PROBLEM IS NOT THE NETWORK IT'S THE INDUSTRY. INDUSTRY DOESN'T COME TO US VERY OFTEN. THAT'S ONE THING BECAUSE THEY WANT TO RUN THEIR OWN TRIAL. THEY DON'T WANT AN INDEPENDENT INVESTIGATOR DOING THEIR TRIAL. SECOND, A LOT OF WHAT WE DO, THERE ARE NO INDUSTRY INTEREST IN IT. MAGNESIUM SULPHATE, CORTICOSTEROIDS, PROGESTERONE -- AT THE BEGINNING THERE WAS NO INDUSTRY THERE. SO THANK YOU FOR LISTENING. >> SO I WANTED TO GO BACK AND TOUCH A LITTLE BIT MORE ON COLLABORATION SPECIFICALLY REGARDING DATA COLLABORATION BECAUSE I THINK WE HAVE TALKED A LOT ABOUT AND SEEN THAT THERE IS NO DATA OUT THERE BUT YESTERDAY ONE OF THE THINGS I WAS STRUCK BY AND TODAY, FROM LISTENING TO THE SPEAKERS IS THE AMOUNT OF DATA THAT IS ACTUALLY THERE THAT WE COULD POTENTIALLY USE. I THINK WHEN WE SAY THERE IS NO DATA, WE ARE REALLY SAYING THERE IS NOT DATA IN THE TRADITIONAL FORMAT THAT WE USUALLY THINK ABOUT. SO THERE IS NOT PUBLISHED TRIALS OUT THERE. AND SO, I THINK COLLABORATION REALLY NEEDS TO FOCUS ON ONE OF ITS MAIN POINTS IS USING THE DATA THAT CURRENTLY EXISTS. FOR EXAMPLE THE DATA IN THE VA SYSTEM, DATA FROM FEDERALLY FINNEDDED RURAL HEALTH ORGANIZATIONS TO REACH THOSE WOMEN THAT MAY NOT TRADITIONALLY HAVE OPPORTUNITIES TO PARTICIPATE IN RESEARCH. AND USING THAT DATA TO AT LEAST PROVIDE SOME BASELINE INFORMATION TO WHAT ARE WOMEN TAKING? WHAT ARE SOME POTENTIAL OUTCOMES? THAT MAY BE OCCURRING THAT CAN DRIVE FUTURE RESEARCH AND ALSO TO PICK UP SAFETY SIGNALS AS WELL. THE OTHER AREA FOR DATA COLLABORATION I THINK IS TO ALSO LOOK OUTSIDE FEDERAL AGENCIES AND TRADITIONAL GROUPS AND THINK ABOUT THINGS LIKE MINING THE INTERNET. SO I WENT TO A TALK ABOUT A YEAR OR SO AGO. THERE WAS AN INVESTIGATOR THAT TALKED ABOUT HOW THEY MINE THE INTERNET AND DATA SEARCHES TO PICK UP SAFETY SIGNALS. THEY MINE THE DARK INTERNET WHICH I DIDN'T KNOW ACTUALLY EXISTED. I THOUGHT THAT WAS ONLY ON TELEVISION BUT THE DARK INTERNET, TO PICK UP EPIDEMICS OF OVERDOSES. SO I THINK ALSO THINKING OUTSIDE TRAPPED ADDITIONAL AREAS THAT IS WE THINK OF -- TRADITIONAL AREAS -- TO GET THOSE DATA SOURCES AS WELL. >> BARBARA WESLEY FROM THE FDA. I HAVE A COUPLE FDA-TYPE COMMENTS TODAY. THERE HAS BEEN A LOT OF DISCUSSION. FIRST OF ALL, I WANT TO PUT A PLUG IN FOR THE CONSORTIUMS LIKE THE MFM NETWORK ET CETERA. CRITICAL TO DO. AND I ALSO THINK THAT WE SHOULD FOCUS ON WHAT IS URGENT. EVERYTHING IS IMPORTANT. EVERYTHING. BUT WHAT IS URGENT ARE THOSE CLINICAL CONDITIONS THAT PEOPLE CAN GET REALLY SICK FROM AND DIE, AND WE AREN'T REALLY FUNCTIONING IN A WAY THAT WE REALLY SHOULD BE. SO, IN ORDER TO DO STUDIES ON THESE PATIENTS, THESE ARE NOT THE 4 MILLION PEOPLE, 4 MILLION PREGNANT WOMEN. THESE ARE A SMALL GROUP OF PEOPLE. MANY OF THEM FIT INTO WHAT I CALL THE DRUG CATEGORY FROM WHICH THEY GET AN APPLICATION APPROVED AT FDA. THEY GET SEVEN YEARS OF EXCLUSIVITY. THAT'S A LOT OF MONEY AND TIME. THAT'S NOT WELL-KNOWN. AND A LOT OF PREGNANCY DRUGS QUALIFY FOR THAT. THE OTHER THING IS MENTIONED, FAST TRACK. THAT'S NOT NEW. FAST TRACK STARTED WITH THE HIV EPIDEMIC AND FAST TRACK HAS GOT A LOT OF COMPONENTS TO T SO I WON'T GET INTO ALL OF THAT BUT WHAT IS BEING USED NOW THAT IS IMPORTANT IS PROVINCIAL APPROVAL ON ONE STUDY WHILE YOU DO THE NEXT STUDY. THE PROVISIONAL AAPPROVAL ON A SURROGATE ENDPOINT LIKE GESTATIONAL AGE AND THEN YOU DOCK ANOTHER STUDY. SO THAT ENHANCES FAST TRACKS IN A SENSE, THAT APPROVAL. ONE CRITICAL THING THAT HAS NOT BEING DONE EVEN THOUGH WE DEFINITELY NEED A LOT MORE CLINICAL TRIALS, IS PHASE II DOSE FINDING STUDIES. OVER 1000 PATIENTS. THEY ARE BIG. 1500. NO SINGLE INSTITUTION CAN DO THAT. YOU MUST HAVE A CONSORTIUM TO DO A PHASE III TRIAL IF ANY OF THE OBSTETRIC SYNDROMES WE TALK ABOUT. THE OTHER THING IS, DOSE FINDING IS CRITICAL FOR BOTH EFFICACY AND SAFETY. WE HAD APPROVED DRUGS THAT HAD SAFETY ISSUES BECAUSE OF NOT HAVING DOSE FINDING. TOP LITTICS BACK IN THE DAY THAT HAD A LOT OF MORBIDITY AND WHENEVER IT DIDN'T HAVE DOSE FINDING. WE ALSO HAVE DRUGS NOW THAT MAY HAVE BEEN APPROVED AND WE HAD DONE -- IF THEY HAD DONE DOSE FINDING BEFOREHAND AND NOT USED A GYNECOLOGIC DOSE AS I CALL IT, BUT A REAL PREGNANCY IS DOSE FINDING STUDY THAT SEE WHETHER THE DOSE IS HIGH ENOUGH OR LOW ENOUGH. AND THAT IS IMPORTANT. THOSE ARE PHASE II STUDIES I THINK THAT INDUSTRY IN PARTICULAR SHOULD WORK WITH THESE COLLABORATIVE GROUPS TO DO SOME OF THESE PHASE II STUDIES TO INFORM THESE PHASE III CLINICAL TRIALS IN WHAT DOSES SHOULD BE USED. THANK YOU. >> THANK YOU SO MUCH. AM I MISSING ANYONE? ANY OTHER THOUGHTS? I HAVE TAKEN OR GOT THREE NICE SLIDES ON CURRENT ONGOING COLLABORATIONS AND COORDINATION ON OPPORTUNITIES AND ON CHALLENGES. SO I'M REALLY PLEASED WITH WHAT WE HAVE HEARD SO FAR. I WANT TO GIVE ONE MORE -- YES? >> I'M VICKI FROM NHLBI AND I THINK ONE THING I'M WONDERING ABOUT AS WE TALK ABOUT WOMEN BEING MORE WILLING TO PARTICIPATE IN STUDIES WHO ARE PREGNANT, AND/OR LACTATING, ONE OF THE EFFORTS WE UNDER TOOK A NUMBER OF YEARS AGO WAS TO CREATE A WEBSITE FOR PARENTS TO UNDERSTAND WHAT IT WAS LIKE FOR THEIR CHILD TO PARTICIPATE IN A STUDY. AND AS I LOOK AT NIH'S CLINICAL TRIALS AND NEW WEBSITE, THERE IS NOT A PREGNANT PATIENT HIGHLIGHTED THERE. THERE IS NOT ANYTHING ABOUT PREGNANCY ON THAT WEBSITE. AND SO I'M CURIOUS WHETHER THERE ARE EFFORTS OUT THERE TO HELPING ENGAGE WOMEN TO THINK ABOUT PARTICIPATING IN WHAT IT MEANS TO PARTICIPATE IN A STUDY DURING PREGNANCY. AND WHETHER WE COULD HELP IN THAT SPACE. >> DR. SPONG: THAT'S A GOOD POINTED AND THAT PROBABLY BRIDGES BOTH THIS PANEL AND THE LAST PANEL WHICH WILL BE ON DISSEMINATION OF THE INFORMATION, WHICH IS NOT ONLY WHAT WE FOUND BUT HOW DO YOU GET INTO A RESEARCH STUDY? SO I APPRECIATE BRINGING THAT UP AND HOPEFULLY IN THE NEXT PANEL WE WILL BE ABLE TO ADDRESS THAT TO SOME DEGREE. I SENT MY SLIDES TO KRISTI WHO UNFORTUNATELY HAS NOW THE TASK OF TRYING TO PULL THEM ON TO A DISK AND PUT PUT THEM UP AND I THOUGHT IT WOULD BE WORTHWHILE TO WALK THROUGH THOSE. GO AHEAD. >> JUST A QUICK COMMENT. I REALLY APPRECIATE THE SENSE THAT THE YOUNGER GENERATION OF WOMEN WHO ARE PREGNANT NOW ARE MORE INTERESTED IN RESEARCH AND I HAVE FOUND THAT TO BE THE CASE AS WELL. I THINK THAT WE HAVE TO KEEP IN MIND THE PROVIDER COMMUNITY AS WELL, THE GENERAL OBGYN PROVIDER COMMUNITY, WHICH I WOULD SAY IS IN GENERAL RISK AVERS AND I DON'T THINK WE SHOULD RUN AROUND THEM. I THINK ENGAGE CEMETERY IMPORTANT. WE NEED TO HAVE THE BACK UP OF THE PRIVATEY COMMUNITY -- ENGAGEMENT IS IMPORTANT -- AND IT SHOULD BE TOWARDS PATIENTS AND CONSUMERS AND PROVIDERS SO WE CAN MOVE EVERYONE FORWARD. AND LIKE I SAID, THE PROVIDEY COMMUNITY SHOULD BE THE FOCUS OF OUR EDUCATIONAL EFFORTS AS WELL. >> DR. SPONG: ANOTHER GOOD POINT. AGAIN BOTH BRIDGING THIS PANEL AND THE NEXT PANEL AS WELL. SO LET'S ALSO KEEP THAT IN MIND. IF YOU COULD GO TO SLIDE 6 AND YES, GO AHEAD. >> I JUST HAD A COMMENT FROM OUR PERSPECTIVE, IMMUNIZATION PERSPECTIVE. MAYBE WE WILL HAVE DONE A LITTLE BIT MORE RESEARCH. FOR US IT'S NOT EASY TO ENROLL PREGNANT WOMEN FOR A VARIETY OF REASONS BUT MOSTLY BECAUSE THESE STUDIES ARE DONE IN DUKE AND VANDERBILT AND SOME OF THE PREGNANT WOMEN REQUIRE FAMILY APPROVAL TOO. SO THERE IS A LOT OF COMPLEXITIES NOT ONLY THE WOMAN HERSELF THAT GIVES THE GO-AHEAD. AND THE OTHER THING THAT I KNOW WE WILL TALK ABOUT ETHICS, BUT WE ARE MOVING FORWARD NOT CALLING THEM VULNERABLE ANYMORE, WHICH IS A GREAT THING AND WE WERE TALKING WITH GEORGE YESTERDAY AND WE ARE VERY GRATEFUL FOR THAT. >> SO JUST TO KIND OF PUT IT BACK INTO PERSPECTIVE. WHAT WE ARE HANDLING OR TALKING ABOUT THIS MORNING IS SUB BULLET 2. THE RECOMMENDATIONS FOR THE COORDINATION OF AND COLLABORATION ON RESEARCH. AND THIS IS WHAT -- SO WE STARTED TALKING ABOUT WHAT IS CURRENT? AND WE HIGHLIGHTED A NUMBER OF ONGOING CURRENT COLLABORATIONS. WE HAVE GOT NETWORKS AND MULTI-CENTER TRIAL INFRASTRUCTURES THAT WE CAN TAP. THESE ARE CURRENT ONGOING THINGS. INDUSTRY IS A LOT OF THINGS ONGOING AS WELL THAT I DON'T THINK WE TAPPED INTO AS MUCH AS WE POTENTIALLY COULD ON THE FEDERAL SIDE. AND WE HAVE HOWEVER COLLAB RATED WITH INDUSTRY THROUGH - COLLABORATE AUDIO - MAINLY THROUGH OTHER DISEASES BUT THROUGH PREGNANCY STUDIES AS WELL IN THE NETWORKS. LOTS EVER OPPORTUNITIES THAT I WAS ABLE TO IDENTIFY JUST FROM THE CONVERSATIONS WE HAD. THE OPPORTUNITY TO FACILITATE COMMUNICATION OF ONGOING EFFORTS ACROSS THE FEDERAL WORKSPACE, ABILITY TO COLLABORATE TO THINK COLLABORATION FIRST WHEN WE ARE DESIGNING SOMETHING. THE OPPORTUNITY TO ENHANCE NETWORKS AND THE OPPORTUNITY TO DO THESE TRIALS TO FACILITATE THE ABILITY TO PUT IN AND GET DATA OUT OF REGISTRIES THE UTILIZATION OF DO. AND VA SYSTEMS FOR COLLABORATION OF RESEARCH. THE OPPORTUNITY TO COLLABORATE WITH INDUSTRY. I THINK THERE IS SAY STRONG INTEREST THERE. THE OPPORTUNITY THAT WE HAVE THAT MILLENNIALS ARE DIGITAL SAFE AND COMFORTABLE WITH SHARING THINGS ON LINE. CAN WE TAP INTO THAT RESOURCE TO ENGAGE THEM? THE LACTATING WOMEN. A HUGE OPPORTUNITY TO DO RESEARCH HERE TO GET INFORMATION AVAILABLE. WILLING ENGAGEMENT. AND THEN THE DATA AVAILABILITY. NOT ONLY IN THE VA AND DOD AND FEDERALLY FUNDED STUDIES. I WANT TO PUT UP THERE NICHD HAS A DASH WHICH IS A OPPORTUNITY TO UTILIZE STUDIES THAT NICHD HAS FUNDED THAT ARE PUBLICLY-POSTED TO BE ABLE TO SEARCH THEM AND IDENTIFY WHAT YOU WOULD LIKE TO STUDY AND USE THOSE DATASETS THAT ARE ALREADY AVAILABLE. AND I KNOW NHLBI HAS ONE OF THESE, NIH HAS ONE. LOTS OF ABILITY TO MINE ALREADY-DONE STUDIES FOR INFORMATION. AND CHALLENGES. RIGHT UP THERE IS LEGAL AND ETHICAL CHALLENGES. THIS IS SAY COLLEGE FOR INDUSTRY, A CHALLENGE AS WELL FOR RESEARCHERS. LIMITED EXPERTISE FOR THE DESIGN OF THESE STUDIES IN THESE POPULATIONS IN INDUSTRY. BUT OF COURSE THEY ARE NIMBLE AND QUICK AND CAN MOVE IF WE HAVE THAT ABILITY. THE EFFICIENCY IS NECESSARY AND IMPORTANT FOR INDUSTRY. TRANSPARENCY IS VERY IMPORTANT. CULTURAL DIFFERENCES ACROSS AGENCIES AND ACROSS INDUSTRY. LOTS OF CHALLENGES WITH REGISTRIES THAT DRUG-CENTRIC REGISTRY. THE DESIGN IS LIMITING. IT WOULD BE EASIER TO GET MORE INFORMATION IF THEY ARE DISEASE-FOCUSED. THEY ARE NOTED OWNED BY THE FDA. THEY ARE OWNED BY THE SPONSOR. AND THEY ARE NOT UNIFORM IN DESIGN, QUALITY OR REPORTING AND THEN THE CHALLENGE OF NEW-PRODUCT DEVELOPMENT. I ADJUSTMENT WANT TOSADE HIGHLIGHT WHAT I GOT OUT OF THIS. THANK YOU. I PUT THIS AT THE ENDS OF THE DAY. WE WILL KIND OF TRY TO SUMMARIZE THINGS BUT I THOUGHT IT WOULD BE WORTH WHILE TO GO THROUGH AND A HIGH-LEVEL. MIKE? >> MIKE GREEN. ONE OTHER POINT THAT I'D LIKE TO AMPLIFY UPON THAT WAS BROUGHT UP BY BOTH DR. SAYEEDHA UDDIN AND DR. WESLEY. GEORGE IS CORRECT. THERE IS A FOCUS ON MATERNAL MORTALITY AND IT IS NO QUESTION THAT IT IS AN IMPORTANT MEASURE OF THE HEALTH OF A POPULATION OF A COUNTRY. IT'S HUGE AND IT IS IMPORTANT. I WILL POINT OUT HOWEVER, THAT PERINATAL MORTALITIY IS MEASURED PER 1000. MATERNAL IS MEASURED PER 100,000. SO PERINATAL ARE 100 TIMES MORE COMMON THAN MATERNAL MORTALITIES. FORTUNATELY AMONG 4 MILLION BIRTHS IN THE UNITED STATES THERE ARE 900 MATERNAL MORTALITIES. WHAT THIS LINKS TO WHAT DR. WESLEY WAS SAYING IS THAT THE TRADITIONAL REASONS WHY WOMEN DIED AROUND CHILDBIRTH, HEMORRHAGE, INFECTION, ARE ALL ON THE DECLINE QUITE DRAMATICALLY. WHAT IS RISING IS THE RISK OF DEATH FROM CARDIOVASCULAR CAUSES, ESPECIALLY AMONG WOMEN IN ADVANCING AGE AS WE SAY. AND THEREIN LIES ITS ROLE FOR SURROGATE OUTCOMES AND SURROGATE ENDPOINTS. BECAUSE WE ARE NEVER GOING TO BE ABLE TO DEMONSTRATE WITH REDUCTIONS IN ACTUAL MATERNAL MORTALITY AN EVENT THAT OCCURS ONLY 900 TIMES IN THE WHOLE COUNTRY AND THAT IS DIVIDED AMONG 10 MAJOR DIFFERENT CAUSES. SO WE HAVE GOT TO USE SURROGATE OUTCOME MEASURES AND THAT WAS BROUGHT UP BY THOSE TWO COMMENTS. >> THANK YOU. YES? >> JUST ONE SMALL POINT ABOUT TERMINOLOGY SINCE OUR VULNERABLE POPULATIONS WERE BROUGHT UP AND THAT IS NOW THAT MILLENNIAL GENERATION MAY BE HAS -- WE MOVED ON TOTE I GENERATION. KIDS BORN FROM 1995 ON HAVE NEVER BEEN WITHOUT -- SO YOU MAY BE TALKING ABOUT A NEW SET OR POPULATION. [ LOW AUDIO ] >> EXACT CAG I THINK WE HAD A REALLY ROBUST DISCUSSION AND I THINK YOU EARNED YOURSELF A BREAK. WE ARE SCHEDULED FOR A BREAK IN 5 MINUTES SO YOU CAN EVEN HAVE THAT EXTRA 5 MINUTES. WE'LL COME BACK AT 10:45. I REALLY APPRECIATE ALL OF THE ENGAGEMENT. I THINK WE ARE REALLY ON A WONDERFUL START FROM THIS MEETING. THANK YOU VERY MUCH. AND WE'LL SEE YOU BACK AT 10:45. >> WELCOME BACK EVERYONE, LOVE THE ROBUST CONVERSATION, THE DIALOGUE AND INTERACTION HAS BEEN FABULOUS. WE ARE GOING TO DEDICATE THIS PORTION OF THE MEETING TO PUBLIC COMMENT. AS OUTLINED IN THE FEDERAL REGISTER, THERE IS AN OPPORTUNITY FOR OPEN COMMENT. WRITTEN STATEMENTS ARE GOING TO BE POSTED ON THE WEBSITES SO THEY WILL BE AVAILABLE FOR EVERYONE. WE ASK THAT THE PRESENTERS KEEP THEIR STATEMENTS TO THREE MINUTES SO EVERYONE HAS TIME TO SPEAK. TO HELP YOU STAY ON TIME WE FORKING TO USE THE CARD SYSTEM. THE GREEN CARD WILL BE DISPLAYED FOR TWO MINUTES AND 30 SECONDS. THE YELLOW WILL INDICATE HAVE YOU 30 SECONDS LEFT TO WRAP UP AND THE RED MEANS STOP. AND YOU CAN GO TO ANY MICROPHONE AROUND THE ROOM THAT YOU PREFER. THE FIRST WILL BE DR. ANITA GUPTA FROM JOHNS HOPKINS CENTER FOR ON GLOBAL HEALTH EDUCATION. >> GOOD MORNING. MY NAME IS ANEAT AND I'M A INFECTIOUS DISEASE RESEARCHER AND CLINICAL RESEARCHER AT JOHNS HOPKINS. I CONDUCT CLINICAL TRIALS IN RESEARCH LARGELY IN INTERNATIONAL SETTINGS. I'M HERE TO TALK TO YOU ABOUT TB. SO TUBERCULOSIS IS ESTIMATED TO IMPACT AT LEAST HALF A BILLION WOMEN GLOBALLY AND IS ASSOCIATED WITH OVER 3 MILLION ACTIVE CASES EACH YEAR. AT LEAST 260,000 IN PREGNANCY. IT'S A LEADING CAUSE OF MATERNAL MORTALITY INCLUDING IN BOTH HIV INFECTEDDED AND UNINFECTED WOMEN WHO ARE BREASTFEEDING AS WELL AS WHO ARE PREGNANT. INFANTS BORN TO MOTHERS WHO ARE WITH TB HAVEAISE HIGHER RATE OF PREMATURITIYMATURITIY AND LOW BIRTHDAY WEIGHT AND STILL BIRTH. IT INCREASES RISK OF HIV TRANSMISSION AND SIGNIFICANT LIE INCREASE SYSTEM MORTALITY OF THE NEWBORN OTHER AND YOUNG CHILDREN IN THE HOUSEHOLD. SO WOMEN OF CHILD BEARING AGE ARE ALSO MORE LIKELY TO PROGRESS FROM LATENT TB INFECTIONS TO ACTIVE TB DISEASE POSSIBLY NEW CHANGES OF PREGNANCY. IN FACT, THE RISK OF DEVELOPING TB IS HIGHEST WITHIN THE FIRST 90 DAYS POSTPARTUM, MORE THAN ANY OTHER TIME IN A WOMAN'S LIFE. HOWEVER, TB PREVENTION AND TREATMENT DURING PREGNANCY POSE CHALLENGES AND YOU HEARD ABOUT MANY OF THESE. PHYSIOLOGIC ADAPTATIONS THROUGHOUT PREGNANCY IN THE THIRD TRIMESTER, THESE CHANGES ARE DYNAMIC AND CAN SIGNIFICANTLY IMPACT DRUG DISPOSITION. THE SAFETY AND EFFICACY OF INDIVIDUAL OR MULTI-DRUG REGIMENS FOR PREGNANT WOMEN CANNOT BE PREDICTED WITHOUT CLINICAL TRIALS YET SAFETY AND PK DATE FOR PREGNANCY FOR TB DRUGS INCLUDING FIRST-LINE TB DRUGS WHICH HAVE BEEN USED SINCE THE 1950s, HAVE BEEN SORELY LACKING. BECAUSE OF THIS LACK OF DATA REGARDING SAFETY AND EFFICACY, AND THE PK AND TB DRUGS, INCONSISTENCIES AND NATIONAL INTERNATIONAL GUIDELINES EXIST. THE WORLD HEALTH ORGANIZATION FOR EXAMPLE RECOMMENDS THE USE OF -- DURING PREGNANCY IN THE FIRST LINE DB TREATMENT BUT US CENTERS FOR DISEASE CONTROL DOES NOT. INADEQUATE DATA ON THE FETAL EFFECTS. THUS THE TYPE OF AND DURATION OF THE TB TREATMENT REGIMEN THAT A PREGNANT WOMEN RECEIVES LITERALLY DEPENDS ON WHICH COUNTRY SHE RESIDES FROM AND WHAT GUIDELINES ARE BEING FOLLOWED. MULTI-DRUG RESIST ENT TB A BIGGER CHALLENGE BECAUSE TREATMENT OPTIONS REMAIN LIMITED DURING PREGNANCY. MOST IMMUNOGLYCOSIDES AND TREATMENT ARE POTENTIALLY TOXIC AND NEVER TOXIC TO THE MOM AND FEET US AND REPRODUCTIVE TOXICITIES STUDIES ADDRESS THAT SECOND-LINE TB DRUGS ALSO HAVE NEGATIVE SEQUELAE. SO ALTHOUGH THERE ARE NEW COMPOUNDS IN THE DEVELOPMENT AND ON THE MARKET, THE LACK OF SAFETY DATA, EFFICACY DATA OR PK DATA FROM PREGNANCY LIMITS THEIR USE IN THE POPULATION AND MDRXRTB HAS MORE THAN ACTEDY% MORALITY. IT'S A SERIOUS CONDITION AND WE HAVE NO DATA TO SUPPORT HOW TO MANAGE THESE IN PREGNANCY OR PUT THE LACTATING WOMEN. FATHER IN-LAW, THE STANDARD REGIMEN OF INH -- FURTHERMORE -- ASSESSED FOR SAFETY IN PK DATA. SO AFTER EXCLUSION OF 13 TRIALS FROM HIV INFECTED INDIVIDUAL ADULTS, A NIH FUNDED PHASE 4 CLINICAL TRIAL DESIGNED TO STUDY INH IN PREGNANCY AND THAT WILL BE FORTHCOMING WITH RESULTS. WHY DID IT TAKE SO LONG TO STUDY A DRUG USED SINCE THE 1950s IN PREGNANT WOMEN? SO WE HAVE REALLY THE ISSUE OF PREGNANT WOMEN SHOULD BE ALLOWED ACCESS TO AND BENEFIT FROM ADVANCES IN TB TREATMENT, PREGNANCY PROVIDES IMPORTANT ENTRY INTO THE HEALTH CARE SYSTEM AND WE MUST ADDRESS THE BURDEN OF LATENT TB INFECTION, ACTIVE TB AND PREGNANCY. AND NOW ISLAND LIKE TO END BY SAYING THAT POTENTIAL BENEFIT OF RESEARCH ON TB DRUGS WOULD BE SIGNIFICANT AND CONSIDERATION MUST ALSO BE GIVEN TO THE CONSEQUENCES OF OFF-LABEL USE IN THE ABSENCE OF EVIDENCE-BASED GUIDELINES. IT'S SAFER TO ADMINISTER TB DRUGS DURING PREGNANCY IN A RESEARCH SETTING GIVEN THE RIGOROUS SAFETY MONITORING REQUISITE INFORMED CONSENT REQUIREMENTS AND ABILITY TO INFORM THE CORRECT DOSING. SO, WE HAVE PUBLISHED A EXPERT CONSENSUS STATEMENT AND PROVIDE RECOMMENDATIONS ON THIS. YOU CAN FIND THAT ARTICLE IN CLINICAL INFECTIOUS DISEASES TWO THOUSANDS 16. WE OUTLINE OUR KEY RECOMMENDATIONS FOR HOW TO INCLUDE WOMEN IN PREGNANT WOMEN IN CLINICAL TRIALS. THANK YOU. >> DR. SPONG: THANK YOU. NOW WE HEAR FROM DR. MOFFIT FROM THE HEALTH AND ENVIRONMENT SCIENCE INSTITUTE. >> GOOD MORNING. MY NAME IS DR. GRAM MOFFIT FROM THE PRECLINICAL AMGEN AND SPEAKING THIS MORNING IN MY CAPACITY AS CO-CHAIR OF THE DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY TECHNICAL COMMITTEE FOR DEVELOPMENTMENT OF TOXICOLOGY WHICH MY COLLEAGUES WILL DESCRIBE LATER ON. DART IS A ORGANIZATION COMPRISING OF SCIENTISTS FROM ACADEMIA, INDUSTRY AND AS WELL AS REGULATORY AGENCIES SUCH AS FDA AND EMA. AND REALLY OUR CORE SUBMISSION TO HELP DEFINE OPTIMAL NON-CLINICAL TESTING STRATEGIES AND MORE IMPORTANTLY HOW TO TRANSLATE THE DATA FROM THESE TESTS INTO MEANINGFUL HUMAN RISK ASSESSMENTS. WHY IS IT SO IMPORTANT? AS WE DISCUSSED AT LENGTH THIS MORNING, THERE ARE NUMEROUS LEGAL AND ETHICAL CHALLENGES TO GENERATE DATA IN PREGNANT AND LACTATING WOMEN IN CLINICAL TRIALS. PRIOR TO MARKETING APPROVAL, GENERALLY THE ONLY DATA WE HAVE TO INFORM HUMAN VISC FROM THESE NON-CLINICAL STUDIES. SO IS THIS SCENARIO REALLY UNDERSCORES OUR RELIANCE ON THESE NON-CLINICAL MODELS AND THE IMPORTANCE OF BEING ABLE TO TRANSLATE WHAT THESE DATA MEAN FOR HUMANS. AND WHAT FROM THE DOCUMENT AS WELL AS MANY OTHER ORGANIZATIONS ARE REALLY CONTRIBUTING TO SIGNIFICANT PROGRESS GRANCY THIS GOAL. RELIEVED TO HEAR SINCE THE TRAGEDY 50 YEARS AGO THERE IS SUBSTANTIAL PROGRESS IN NON-CLINICAL TESTING. IMPROVEMENTS IN INTEGRATING OUR INCREASED SCIENTIFIC UNDERSTANDING OF PREGNANCY AND LACTATIONING AND ESPECIALLY OUR TRANSPORT MECHANISM RESPONSIBLE FOR MEDIATING DRUG EXPOSURE TO BOTH DEVELOPING FETUS AS WELL AS BREAST-FED INFANTS. AND TESTING HAS BEEN MODIFIED ALMS TO TRY TO MEET THE EVER-CHANGING DEVELOPMENTS OF THE DRUG DEVELOPMENT LANDSCAPE AND THIS HAS BEEN MOSTEST WITH THE INTRODUCTION OF DIFFERENT DRUG MODALITIES PARTICULARLY BY PHARMACEUTICALS. FOR THESE MOLECULES BOTH IN HUMANS AND IN NON-CLINICAL SPECIES, WORK DONE BY ORGANIZATIONS HAVE SHOWN THAT THE ABILITY OF THESE MOLECULES TO BOTH TRANSFER AND REACH SECRETION TO BREAST MILK IS GENERALLY MUCH MORE LIMITED THAN TRADITIONAL SMALL MOLECULES. FURTHERMORE, WORK DONE BY A NUMBER OF ORGANIZATIONS INCLUDING DART, HAS SHOWN THAT TRYING TO UNDERSTAND THE SIMILARITIES AND DIFFERENCES BETWEEN THE MECHANISM OF PLACENTAL TRANSFER BETWEEN A NON-CLINICAL SPECIES AS WELL AS HUMANS. AND THE OUTCOME OF THAT IS WE HAVE BEEN ABLE TO HAVE A MUCH MORE INFORMED OPINION AS TO THE POTENTIAL 450U78 RISK FOR DRUG TRANSFER. IN ADDITION TO THESE INSIGHTS, SIGNIFICANT ADVANCEMENTS HAVE BEEN MADE IN OUR SCIENTIFIC UNDERSTANDING OF NORMAL VERSUS ABNORMAL DEVELOPMENT AND AN EXAMPLE BEING IN THE CHARACTERIZATION OF OUR SO-CALLED ADVERSE OUTCOME PATHWAYS. THESE ACHIEVEMENTS HAVE BEEN COMPLIMENTED BY THE DEVELOPMENT OF A NUMBER OF PRETTY ELEGANT ALTERNATIVE METHODS AND THESE REALLY HAVE BEEN AIMED AT ENHANCING OUR ABILITY TO BOTH INTERROGATE MECHANISMS AS WELL AS SPEED UP THE DISCOVERY PROCESS AS WELL AS INCREASE MECHANISTIC UNDERSTANDING SO WE HAVE BEEN ABLE TO REFINE THE CHEMISTRY FOR DRUG MOLECULES BEFORE WE TEST IN HUMANS. SO IN SUMMARY, NON-CLINICAL TESTING WILL BE REMAIN THE BASTIAEN FOR PREGNANT AND LACTATING WOMEN AND THEIR OFFSPRING. AND GAPS IN KNOWLEDGE EXIST AND IT'S IMPORTANT WE LEVERAGE THAT UNDERSTANDING REALLY INFORM AND MAKE THE MOST OF THE INFORMATION WE HAVE AND BY DOING THAT, WE CAN ASSURE HUMAN RISK ASSESSMENTS ARE BASED ON THE MOST ROBUST SCIENCE AVAILABLE TO US. SO WE THANK THE TASK FORCE FOR THE OPPORTUNITY TO SHARE CONTRIBUTIONS, NON-CLINICAL RESEARCH MAKE TO THE EFFICACY OF DRUGS IN PREGNANT AND LACTATING WOMEN AND HOPE YOU WILL ENCOURAGE IT TO INCLUDE THESE IN YOUR DELIBERATIONS AND FINAL REPORT. THANK YOU. >> DR. SPONG: THANK YOU VERY MUCH. NEXT WE HEAR FROM LINDSAY FROM THE TREATMENT ACT GROUP. TREATMENT ACTION GROUP. >> GOOD MORNING. THANK YOU FOR ORGANIZING AND THE TASK FORCE FOR COMMITMENT TO FINDING SOLUTIONS FOR PREGNANT WOMEN AND THE CLINICIANS CHARGE% WITH THEIR CARE AND FOR ALLOWING THIS OPPORTUNITY FOR THE PUBLIC TO OFFER OUR PERSPECTIVES. WE FOCUS COMMENTS ON RESEARCH FOR PREGNANT WOMEN WITH TB. MY NAME IS LINDY MCKENNA AND WORK AT TREATMENT ACTION GROUP, AN INDEPENDENT ACTIVIST AND COMMUNITY-BASED RESEARCH AND POLICY THINK TANK FIGHTING FOR BETTER TREATMENT PREVENTION VACCINE AND A CURE FOR HIV, T.% AND HEPATITIS C FOR 25 YEARS. WE FIRST BECAME ENGAGED IN ISSUES RELATED TO PREGNANCY AND RESEARCH WHILE REVIEWING CLINICAL TRIAL PROTOCOLS. WE NOTICED OVER AND OVER AGAIN IDENTICAL LANGUAGE USED TO EXCLUDE PREGNANT WOMEN FROM RESEARCH. EVEN WHEN THE RATIO POTENTIAL BENEFIT TO HARM FAVORED THEIR INCLUSION IN TRIALS. WE RECOGNIZE THAT IN THE ABSENCE OF EVIDENCE CLINICIANS ARE PUT IN A POSITION OF TREATING WOMEN WITH MEDICINES WITHOUT ADEQUATE GUIDANCE INCLUDING DOSAGE ADJUSTMENT SAFETY AND EFFICACY AND THE RISKS AND BURDEN OF ANXIETY IS CREATING FOR WOMEN WHO REQUIRE TREATMENT WHILE PREGNANT. AND SO WE HAVE BEEN WORKING TO CHALLENGE THIS ASSUMPTION THAT PREGNAN WOMEN CANNOT BE SAFELY AND ETHICALLY INCLUDED IN RESEARCH. TAGS EFFORTS IN THINKING AROUND THIS ISSUE HAVE BEEN FOCUSED AROUND TB AND HIV BUT THE IDEAS WE HAVE FOR HOW TO CLOSE DATA GAPS HAVE THE POTENTIAL TO BENEFIT WOMEN WITH AT RISK OF OTHER DISEASES AND FINNECTIONS -- INFECTIONS AS WELL. WE LIKE TO APPEAL TO THE TASK FORCE TO FURTHER INVESTIGATE AND CONSIDER INCLUDING THE FOLLOWING AMONG RECOMMENDATIONS TO HEALTH AND HUMAN SERVICES FOR HOW THE FEDERAL GOVERNMENT CAN HELP ADDRESS GAPS IN RESEARCH FOR PREGNANT AND POST PREGNANT WOMEN. ONE, DEVELOP INTERNATIONAL REGISTRY TO COLLECT DATA ON INCIDENTS OF DIVERSE EVENTS AMONG PREGNANT WOMEN TREATED FOR TB AND OTHER INDICATIONS. TWO, ESTABLISH A MANDATE FOR RESEARCH NETWORKS INSTITUTIONS AND INVESTIGATORS NA RECEIVE FUNDING FROM THE U.S. GOVERNMENT TO PUT IN PLACE A STANDING PROTOCOL TO ALLOW FOR ENROLLMENT IN PREGNANT WOMEN IN STUDIES THEY CONDUCT IN THREE, WORK WITH FDA AND POLICYMAKERS TO CRAFT REGULATORY POLICY OR LEGISLATION TO CODIFY THE ASSESSMENT OF NEW THERAPIES IN PREGNANT AND POSTPARTUM WOMEN WHICH CAN BE ENFORCED BY FDA. PRIORITIZATION OF DISEASES ON WHICH THE TASK FORCE AND THE FEDERAL GOVERNMENT WILL FOCUS ITS EFFORTS IS INEVITABLE. AND I ENCOURAGE THE TASK FORCE TO ENSURE THAT PRIORITIES ARE NOT DETERMINED SOLELY BY THE BURDEN OF DISEASE IN THE U.S. WHICH WILL LEAVE OUT DISEASES LIKE ZIKA AND TB BUT ALSO IN TERMS OF THREATS TO GLOBAL HEALTH SECURITY. IT WASN'T MENTIONED AS ONE OF AN EXAMPLE YESTERDAY OR EARLIER TODAY, AND I DIDN'T SEE IT IN THE PACKET OF OUTLINING EXISTING FEDERAL ACTIVITIES RELATED TO RESEARCH IN PREGNANT WOMEN, BUT THE INTERNATIONAL ADOLESCENT AIDS CLINICAL TRIALS NETWORK OR IMPACT NETWORK IS FUNDED BY THE NIH AND A GREAT EXAMPLE OF HOW PREGNANT WOMEN CAN BE INCLUDED IN RESEARCH INCLUDING RANDOMIZED CONTROL TRIALS. YOU'LL HEAR MORE ABOUT THE IMPACT NETWORK LATER IN THE PUBLIC COMMENTS BUT I WANTED TO QUICKLY MENTION THE IMPACT NETWORK ALONG WITH FOUR OTHER CLINICAL RESEARCH NETWORKS UNDER THE NIH'S DIVISION OF AIDS WILL BE UP FOR RECOMPETITION IN 2020. SO DAIDS IS SOLICITING FEEDBACK FOR HOW NETWORK SHOULD BE STRUCTURED AND WHAT SCIENTIFIC QUESTIONS THEY SHOULD ANSWER. I'D LIKE TO ENCOURAGE YOU TO LEARN MORE ABOUT THE IMPACT NETWORK AND ENGAGE WITH DAIDS LEADERSHIP TO ENFORCE IMPORTANCE IN EXPERTISE IT BUILT TO FACILITATE FUTURE RESEARCH IN PREGNANT AND POSTPARTUM WOMEN. THANK YOU. >> DR. SPONG: THANK YOU VERY MUCH. WE WILL HEAR FROM DR. JENNIFER FROM SCRIPPS TRANSLATIONAL SCIENCE INSTITUTE. >> GOOD MORNING. MY NAME IS JENNIFER AND I'M EPIDEMIOLOGIST AT SCRIPPS TRANSLATIONAL SCIENCE INSTITUTE AND THE PRINCIPAL INVESTIGATOR ON THE HEALTHY PREGNANCY STUDY. FOR THOSE WHO THE NORFAMILIAR WITH STSI, WE ARE AIMED TO REPLACE A STATUS QUO OF ONE-SIZE-FITS-ALL MEDICINE WITH INDIVIDUALIZED HEALTH CARE. NOW HEALTHY PREGNANCY STUDY IS A PROSPECTIVE LONG TERM RESEARCH KIT APP CREATED IN COLLABORATION WITH STSI AND WEBMD. THE APP IS CURRENTLY AVAILABLE FOR DOWNLOAD FROM THE ITUNE STORE. THE STUDY AIMS TO IMPROVE OUR UNDERSTANDING OF PREGNANCY THROUGH THE COLLECTION OF BOTH SURVEY AND CONNECTED DEVICE DATA. WE ARE ALREADY COLLECTING SOME SENSOR DATA ON WEIGHT, ACTIVITY, SLEEP, BLOOD PRESSURE AND HEART RATE THROUGH APPLES HEALTH APP. AND AS THE AVAILABILITY OF INCREASING ARRAY OF APPS AND WIRELESS CONNECTED DEVICES GROW, WE ALSO ANTICIPATE INCLUDING EVEN MORE PARAMETERS SUCH AS URINALYSIS, NUTRICIAN STRESS AND GLUCOSE. CURRENTLY ALL PREGNANT WOMEN LIVING IN THE U.S. WHO OWN AN iPHONE AND ARE COMFORTABLE WRITING AND READING ON IT IN ENGLISH ARE ELIGIBLE TO JOIN OUR STUDY. HOWEVER, IN THE NEAR FUTURE, WE ALSO HOPE TO EXPAND THE APP TO ANDROID PHONES, OTHER LANGUAGES, OTHER COUNTRIES AND EVEN POSTPARTUM WOMEN AND THEIR BABIES. SINCE LAUNCHING THE STUDY IN THE END OF MARCH, WE HAVE ALREADY ENROLLED OVER 1400 PARTICIPANTS. THE HEALTHY PREGNANCY STUDY COLLECTS VACCINATION AND MEDICATION DATE AT PRESCRIBED AND OVER THE COUNTER DURING AN INITIAL IN TAKE QUESTIONNAIRE AND ALSO SURVEYS. THIS DATA CAN BE LINKED WITH OUTCOME VARIABLES SUCH AS PREGNANCY COMPLICATIONS, SYMPTOMS, PHYSIOLOGICAL MEASUREMENTS, ACTIVITIES, SLEEP, BIRTH OUTCOMES AND MORE. WE HAVE ALREADY ANALYZED SOME OF THE INITIAL DATA FROM OUR STUDY AND HAVE FOUND THAT ANTI-DEPRESSANTS, THYROID DRUGS, DIABETES DRUGS, ARE SOME OF THE MOST COMMONLY-PRESCRIBED MEDICATIONS AND ALLERGY, PAIN, HEARTBURN, PROBIOTICS, AND SLEEP DRUGS ARE SOME OF THE MOST COMMONLY TAKEN OVER-THE-COUNTER MEDICATIONS. I KNOW THAT THE FDA IS MOVING AWAY FROM THE LETTER CATEGORIZATION OF MEDICATIONS DURING PREGNANCY HOWEVER, SIX OF THE TOP 10 PRESCRIBED MEDICATIONS AND TWO OF THE TOP 10 OVER-THE-COUNTER MEDICATIONS TAKEN BY WOMEN IN OUR STUDY ARE CATEGORY C DRUGS. AND THIS HIGH PREVALENCE OF DRUGS REALLY HIGHLIGHTS INCREDIBLE NEED TO PROVIDE WOMEN WITH BETTER EVIDENCE-BASED INFORMATION ON MEDICATIONS THAT THEY ARE ALREADY TAKING. SO ULTIMATELY BY CROWD SOURCING DATA FROM HUNDREDS OF THOUSANDS OF WOMEN WHICH IS OUR GOAL, THROUGH A VERY POPULAR PREGNANCY APP, WE REALLY HOPE TO FILL IN AN IMPORTANT RESEARCH GAP REGARDING PREGNANCY-RELATED DRUG AND VACCINE SAFETY AS WELL AS EFFECTIVENESS. WE ALSO HOPE TO HELP IMPROVE INDIVIDUALIZED DRUG RECOMMENDATIONS BASED ON FACTORS SUCH AS AGE, RACE, BMI AND CO-MORBIDITIES. THANK YOU. >> DR. SPONG: THANK YOU VERY MUCH. [ APPLAUSE ] AND DR. SHARON FROM FAMILY HEALTH INTERNATIONAL. >> HI, MY NAME IS SHARON, THE PI FOR THE INTERNATIONAL MATERNAL PEDIATRIC ADOLESCENT AIDS CLINICAL TRIAL, OR IMPACT. OUR NETWORK IS A GLOBAL COLLABORATION OF CLINICAL INVESTIGATORS FUNDING PARTNERS AND COMMUNITY REPRESENTATIVES ORGANIZED FOR THE PURPOSE OF EVALUATING INTERVENTIONS TO TREAT AND PREVENT HIV INFECTION AND CONSEQUENCES IN PREGNANT AND POSTPARTUM WOMEN, INFANTS, CHILDREN AND ADOLESCENCE. NETWORK IS FUNDED BY NIAID, NICHD AND NIMH. OUR NETWORK HAS TWO DECADES OF EXPERIENCE CONDUCTING CLINICAL RESEARCH IN PREGNANT AND POSTPARTUM WOMEN WITH THE STRONG U.S. DOMESTICKING AND INTERNATIONAL PRESENCE. WE WORK WITH 52 SITES, 22 IN THE U.S. AND 30 IN 13 OTHER COUNTRIES. THESE SITES BRING EXTENSIVE CLINICAL TRIAL CAPACITY AND MORE IMPORTANTLY, A WEALTH OF EXPERIENCE FOR IMPLEMENTATION OF OUR SCIENTIFIC AGENDA. WE HAVE AN EXCELLENT TRACK RECORD OF PRODUCTIVITY WITH DATA FROM OUR STUDIES INFORMING AND SHAPING PUBLIC HEALTH POLICY AND GUIDELINES IN THE U.S. AND WORLDWIDE. OUR RESEARCH AGENDA FROM THE STRONG COLLABORATIVE PARTNERSHIPS WITH OTHER RESEARCH ORGANIZATIONS, PHARMA, PRIVATE INDUSTRY, AND OTHER GROUPS. THE NETWORK IS WELL-KNOWN FOR STUDYING HOW TO PREVENT MOTHER TO CHILD TRANSMISSION OR MPTCT, A RESEARCHER AGENDA AND EXPERTISE STRETCH MUCH FURTHER THAN THAT. WE ARE EXPERIENCED CLINICAL RESEARCHERS WITH A PASSION FOR SOLVING PROBLEMS IN OUR SPECIFIC WE HAVE LEARNED FROM OUR EXPERIENCE IN THESE STUDIES THAT WHEN PROPERLY INFORMED, PREGNANT AND BREASTFEEDING WOMEN ARE EXCITED TO PARTICIPATE IN CLINICAL RESEARCH AND CAN SUCCESSFULLY BE ENROLLED IN A WIDE RANGE OF CLINICAL TRIAL STUDY DESIGNS. I'LL GIVE YOU AIFY EXAMPLES OF THIS. ONE OF THESE IS OUR MASTER STUDY FOR EVALUATION OF HIV AND TB DRUGS IN PREGNANT AND POSTPARTUM WOMEN. THIS TRIAL HAS EVALUATED OVER 900 WOMEN IN OVER 20 DIFFERENT AGENTS TO DATE AND PROVIDED ESSENTIAL AND PREVIOUSLY NON NON-EXISTENT INFORMATION ON APPROPRIATE DRUG DOSING OF THESE THERAPIES ACROSS THE TRIMESTERS AS WELL AS POSTPARTUM. THIS UNIQUE TRIAL ALSO INCLUDES THE POSSIBILITY TO STUDY WASH OUT AND POST-DELIVERY PK OF THESE DRUGS IN INFANTS AS WELL AS THEIR PARENTS. RECOGNIZING MOTHERS AND INFANTS ARE PATIENTS IN THEIR OWN RIGHT AND THEY ARE NOT SIMPLY EXTENSIONS ONE OF THE OTHER. THIS TEMPLATE STUDY LED BY EXPERTS IN OBSTETRICS, PEDIATRICS AND PHARMACOKINETICS AND SAFETY BROUGHT PUBLIC ABILITY TO OTHER LICENSED TREATMENTS THAT ARE COMMONLY USED IN PREGNANT AND POSTPARTUM WOMEN. THERAPIES THAT DESPITE THE ABSENCE OF DATA, ARE OFTEN USED IN THESE POPULATIONS. WE HAVE ENORMOUS STRENGTH IN STUDYING EMERGING INFECTIONS IN PREGNANT WOMEN AT THE HEIGHT OF THE H1N1 EPIDEMIC. OUR NETWORK DEVELOPED, FIELDED AND COMPLETED ENROLLED A STUDY OF NOVEL H1N1 VACCINES IN PREGNANT WOMEN WITHIN A THREE-MONTH TIMEFRAME. I CHALLENGE ANY OTHER NETWORK TO DO THAT. THIS DEMONSTRATED OUR NETWORK HAS A SUCCESS IN WHAT IT SETS TOUT ACCOMPLISH. OUR NETWORK ALSO KNOWS WHEN TO CHALLENGE THE STATUS QUO AS SEEN BY OUR NEARLY COMPLETED STUDY OF INH IN PREGNANT WOMEN AT HIGH-RISK FOR TB. THE EXISTING GUIDELINES RECOMMENDS ADMINISTERING A STANDARD ADULT DOSE OF INH TO PREGNANT WOMEN AND RISK OF TB DESPITE EXTREMELY LIMITED DATA ON THE PK AND SAFETY AND EFFECTIVENESS OF THIS APPROACH IN PREGNANT WOMEN TO ADDRESS THE GAP. WE DEVELOPED A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL IN PREGNANT WOMEN AND ENROLLED ALREADY OVER 900 OF THESE WOMEN WITHIN ONE YEAR. WE ANTICIPATE THAT THE RESULTS FROM THIS STUDY WILL INFORM OR PERHAPS EVEN CHANGE PUBLIC HEALTH POLICY WITH REGARD TO INH. INVESTIGATORS FROM THE AGENCIES, ETHICS COMMITTEES AND INSTITUTIONAL REVIEW BOARDS MUST LET GO OF THE MIND-SET THAT PREGNANT WOMEN OR EVEN WOMEN WHO COULD BECOME PREGNANT, SHOULD AUTOMATICALLY BECOME EXCLUDED FROM STUDIES OF NOVEL THERAPY. WE DEMONSTRATE THAT SUCH STUDIES DESIGNED SPECIFICALLY FOR POPULATIONS CAN BE DEVELOPED, IMPLEMENTED AND ANALYZED IN A SAFE TIMELY AND EFFECTIVE MANNER. THE IMPACT NETWORK IT IS AN EXISTING UNIQUE AND VALUABLE RESOURCE FOR WHICH FUNDING SHOULD BE CONTINUED. OUR NETWORK'S EXPERTISE AND INFRASTRUCTURE FOR PREGNANT AND POST PARTS UM WOMEN AND THEIR BABIES CAN AND SHOULD BE UTILIZED TO STUDY OTHER DISEASES IN PATHOGENS IN THESE IMPORTANT BUT NEGLECTED POPULATIONS. WE HOPE THAT WE CAN HAVE OUR SUCCESS SYSTEM BECOME YOUR SUCCESSES. >> THANK YOU. NEXT WE'LL HEAR FROM Mrs. KATO BRIAN. WE ARE TB. >> PUBLIC COMMENTS OF THIS TASK FORCE SO IT IS REALLY EXCITING FOR ME. I'M SPEAKING TO YOU AS A MEMBER OF THAT AFFECTED POPULATION IN 2015. I WAS PREGNANT WITH MY SECOND CHILD AND I WAS SUPER EXCITED. IT WAS GOING TO BE AWESOME. BUT I JUST STARTED FEELING TERRIBLE AND I HAD A BUNCH OF MISDIAGNOSES IN A ROW AND I LANDED IN ICN NEW YORK CITY. AND I FOUND OUT I HAD ACTIVE TB. AT THAT POINT, I WAS A PLUS 4 AND VERY, VERY BIG, VERY ILL. THAT'S ANOTHER STORY BUT I ONLY HAVE THREE MINUTES. SO, EVERYBODY IS FAMILIAR WITH TB. IT'S A HUGE CITY AND GREAT DOCTORS IN MY HOSPITAL AND I HAD A DRUG SUSCEPTIBLE STRAIN OF TB. LIKE MY TB WAS VERY BORING AND STANDARD. BUT, I WAS PREGNANT AND EVEN THOUGH PREGNANT WOMEN HAVE HAD TB FOR AS LONG AS IT'S BEEN AROUND, THAT SEEMED TO THROW A WRENCH INTO ABSOLUTELY EVERYTHING. I WAS GIVEN THE TYPICAL FIRST-LINE DRUGS. THEY ALL PASSED THROUGH THE LIVER. SO I WAS LIKE WAKE UP SCRATCHING AND LIKE MY SKIN MUST BE STRETCHING OR MAYBE IT'S THE ISOLATION ROOM I'M IN. BUT NO, I HAD HEP TIGHTIS. MY LIVER WAS JUST THE LEVELS WERE GOING THROUGH THE ROOF. I COULDN'T TAKE PZA, SO BASICALLY AND -- IN BETWEEN, WE WOULD HAVE TO LET MY LIVER COOL DOWN SO I WOULD THEN BE OFF MEDICATION FOR A WEEK. SO I WAS IN ISOLATION FOR 75 FACE AWAY FROM MY FAMILY, AWAY FROM MY OTHER SON. IT WAS IS NOT A GREAT TIME. IT WAS AWFUL ACTUALLY. IT WAS AWFUL FOR ME IN A LOT OF WAYS. IT WAS HARD ON OUR FINANCES AND HARD ON OUR FAMILIES AND HARD ON EVERYBODY'S. I HAD NO IDEA WHEN I WAS GOING TO GET OUT. MY LIVER WOULD BASICALLY -- WE JUST NO IDEA WHAT WAS GOING TO HAPPEN. I HAVE A DISEASE THAT HAS BEEN CURED FOR DECADES, A STRAIN THAT HAS BEEN CURED FOR DECADES. AND THAT IS BEING TREATED IN WOMEN VERY POPULOUS COUNTRY. LIKE I KNOW PEOPLE IN CHINA AND EUROPE HAVE T. AND THEY ARE HAVING BABIES. AND FOR SOME REASON, I WAS STILL AN EXPERIMENT. MY BABY WAS STILL AN EXPERIMENT. I HAD NO IDEA WHAT WAS GOING TO HAPPEN TO MY BABY. THIS WAS INCREDIBLY STRESSFULLATION AND DIFFICULT SITUATION. AND FOR ME, I'M A MIDDLE-CLASS AMERICAN WITH GOOD INSURANCE. I'M LIKE THE BEST POSSIBLE SCENARIO TO GET TB WHEN YOU'RE PREGNANT AND IT WAS HORRIBLE. SO, ANYWAY, WE JUST KEPT WONDERING IF WE SHOULD DELIVER EARLY TO TREAT ME? EVERYONE WAS CONCERNED ABOUT KILLING THE TB BUT I REALLY WAS CONCERNED ABOUT MY BABY. I LOVED MY BABY. I WAS ALL ALONE IN THAT ROOM AND I WAS TALKING TO MY BABY. AND I WAS WORRIED ABOUT MY BABY. AND IT'S A HARD SITUATION TO THINK YOUR OWN HEALTH -- AND YOUR BABY'S HEALTH CAN BE SO INTERTWINED AND YOU COULD BE HURTING YOUR BABY WITH THINGS YOU NEED. SO, IT JUST VERY IMPORTANT THAT I FEEL LIKE YOU'RE ALL ON MY SIDE HERE AND YOU KNOW THE PREGNANCY ISN'T A COMPLICATION OR A CONDITION. AND IT'S NOT OR SHOULDN'T BE EXCLUSION CRITERIA FOR SOMETHING I'M GOING HAVE TO TAKING WHEN I'M PREGNANT. SO I WANT TO CHEERLEAD YOU GUYS AND LET YOU KNOW WHAT YOU'RE DOING IS VERY IMPORTANT TO AMERICANS AND VERY IMPORTANT TO PEOPLE THAT ARE HERE RIGHT NOW. THE REGISTRY THAT TAG TALKED ABOUT WITH THIS SORT OF DATA IT WOULD HAVE CHANGED THE EXPERIENCE FOR ME. I WOULD HAVE TAKEN DIFFERENT MEDICATIONS AND RETURNED TO MY FAMILY FASTER. I AND WANT TO SAY THE WORK YOU'RE DOING IS VERY, VERY IMPORTANT TO WOMEN ALL OVER THE WORLD AND I WANT TO THANK YOU ON BEHALF OF MY FAMILY AND MY CHILDREN. THANK YOU. [ APPLAUSE ] >> DR. SPONG: THANK YOU. NEXT Mrs. SHEILA FROM THE AMERICAN ACADEMY OF ASTHMA AND IMMUNOLOGY. >> NOT ONLY AM I THE LAST ONE BETWEEN AND YOU LUNCH, I GET TO FOLLOW KATE. GOOD MORNING. I'M SHEILA AND I'M WITH THE VACCINES AND MEDICATIONS AND PREGNANCY SURVEILLANCE SYSTEM OR VAMPS. AND IT'S A NATIONAL PREGNANCY OUTCOME PUBLIC-PRIVATE RESEARCH MODEL COORDINATED BY THE AMERICAN ACADEMY OF ALLERGY, ASTHMA AND IMMUNOLOGY DESIGNED TO CONDUCT OBSERVATIONAL STUDIES ABOUT MEDICATION AND VACCINE SAFETY IN PREGNANCY. ON BEHALF OF THE VAMPS INVESTIGATORS, WE APPLAUD THE TASK FORCE AND IDENTIFYING EXISTING SOURCES OF RELEVANT DATA, PROPOSING METHODS FOR BRINGING TOGETHER THESE EXISTING DATA SOURCES TO FACILITATE AMALGAMATED REVIEW AND IDENTIFYING GAPS IN RESEARCH IN THIS TOPIC AREA. HOWEVER, WE WISH TO EMPHASIZE ESTABLISHED IN MORE THAN ONE COMPREHENSIVE REVIEW ALREADY. THAT MORE THAN 80% OF THE PRESCRIPTION MEDICATIONS CURRENTLY ON THE MARKET IN THE U.S. HAVE NO OR INADEQUATE PREGNANCY SAFETY DATA. WHEN WE CONSIDER OVER-THE-COUNTER AND HERBAL PRODUCTS WHICH ARE MORE COMMONLY USED BY PREGNANT WOMEN THAN PRESCRIPTION MEDICATIONS, THE NUMBER OF PRODUCTS WITH NO OR INADEQUATE PREGNANCY SAFETY DATA IS LIKELY CLOSER TO 100%. WHILE THIS IS JUST ONE OF THE NATIONAL RESEARCH GROUPS THAT PROVIDES IMPORTANT SOURCE OF RELEVANT DATA ON SAFETY PREGNANCY FOR BOTH PRESCRIPTION AND OVER-THE-COUNTER MEDICATIONS AND VACCINES; WE WANT TO MAKE CLEAR THAT WE BELIEVE THAT THE OVER ARCHING AND OVERWHELMING CHALLENGE OF THIS TASK FORCE IS GOING TO BE IN ADDRESSING THE LACK OF SAFETY DATA. THERE IS NO EXISTING SINGLE OR COMBINED SET OF RESEARCH PROGRAMS IN THIS FIELD THAT IF ANYWHERE NEAR SUFFICIENTLY SUPPORTED TO ADDRESS THIS RESEARCH GAP THAT EFFECTS EVERY WOMAN AND CHILD IN THIS COUNTRY. THANK YOU. >> DR. SPONG: THANK YOU. AND WE WILL LAST HEAR FROM JONATHAN AND NATHAN FROM THE WOMEN'S CHOICE PHARMACEUTICALS. THEY JUST GOT HERE IN TIME. THANK YOU TO NIH SECURITY FOR FACILITATING THAT. >> THANK YOU. [ INAUDIBLE ] THE TASK FORCE IS FEDERAL AGENCIES, SOME PUBLIC-PRIVATE PARTNERSHIPS AND SO, FROM THE INDUSTRY SIDE, WE WANTED TO LET THE GROUP KNOW FIRST OF ALL THAT WE HAVE A NUMBER OF BODIES WHO ARE HAPPY TO GO RESEARCH AS MUCH AS YOU NEED TO OVER THE NEXT YEAR TO GET EVERYTHING READY FOR THE REPORT THAT IS DUE TO THE SECRETARY NEXT SEPTEMBER. SO, WE ARE GOING TO BE PROVIDING A WRITTEN STATEMENT AS WELL AND WE'LL GET IT CIRCULATED. BUT IN THE MEANTIME WE FELT IT WAS IMPORTANT -- FIRST I SHOULD REMIND YOU WHO I AM. NATHAN NELSON FROM BALL CHEM CORPORATION BUT REALLY HERE ON BAST OF THE PRESCRIPTION PRENATAL VITAMIN GROUP, A COALITION THAT IS RECENTLY BEEN FORMED DUE TO A GAP THAT I'M GOING TO TALK ABOUT IN SORT OF WHAT I WOULD REFER TO AS THE LOGISTICS OF GETTING THERAPIES ULTIMATELY SAFE AND EFFECTIVE THERAPIES TO PATIENTS AND HAVING THOSE PATIENTS COMPLY WITH THOSE THERAPIES. AND THERE IS A SITUATION WHERE SOME INSURACE COMPANIES WHO ARE IN THIS STREAM FROM THE RESEARCH AND KNOWLEDGE WE ARE TALKING ABOUT ON ITS WAY TO A PATIENT WHO CAN UTILIZE THAT KNOWLEDGE FOR THEIR BENEFIT. INSURANCE COMPANIES ARE TRYING TO GO IN AND SAY THERE ISN'T ENOUGH RESEARCH OR UNDERSTANDING ABOUT SOME OF THESE THINGS SO LET'S PULL THEM FROM THE MARKET. THE PROBLEM IS, EVERY PRENATAL VITAMIN THAT ANY OF YOU OB DOCTORS HAVE PROBABLY EVER PRESCRIBED TO YOUR PATIENT FALLS WITHIN THE CATEGORY OF WHAT IS TECHNICALLY UNDER THE LAW REFERRED TO AS A DIETARY SUPPLEMENT. AND SO THE INSURANCE COMPANIES SAY, WE DON'T REALLY KNOW IF DRUGS HAVE A LOT OF RESEARCH OR IF DIETARY SUPPLEMENTS HAVE A LOT OF RESEARCH BUT WE THINK THEY ARE JUST SUPPLEMENTS SO LET'S NOT COVER THEM. AND THAT PUTTINGS SCORES OF WOMEN INTO AT RISK POPULATIONS, NOT TO MENTION NEURAL TUBE DEFECT ISSUES THAT WOULD COME FROM WOMEN NOT GETTING THEIR FOLIC ACID. A LOT OF PEOPLE SAY THEY CAN JUST GET IT OTC. WELL, YOU HAVE A LOT OF MEDICAID PATIENTS WHO IF THEY HAVE AN EXTRA 30 DOLLARS, THEY ARE ACTUALLY NOT GOING TO SPEND IT ON AN OTC. THEY PREFER TO MAKE SURE THAT THEY PUT FOOD ON THE TABLE. SO THESE POORER POPULATIONS WE HAVE IN THE COUNTRY WHO ARE AT RISK FOR SIGNIFICANT NEURAL TUBE DEFECT INCREASES. THAT'S WHY WE HAVE FORMED THIS COALITION. AND THE COALITION WANTS TO, WITH THIS GROUP, ENSURE THAT WE HAVE A NUMBER OF PEOPLE TO HELP PROVIDE RESEARCH TO ADDRESS THE FOLLOWING GAP. AND THAT IS THE GAP OF RESEARCH AND KNOWLEDGE THAT IS OUT THERE AND WE ARE DOING SORT OF AN INVENTORY OR AUDIT ON EVERYTHING THAT SOUGHT THERE. AND WILL WE HAVE DIVVIED UP THE WORK AND WE ARE GOING TO GO OUT AND LOOK AND SEE WHAT IS AVAILABLE AS IT RELATES FIRST SCOPE IS, ORAL TO PRESCRIPTION MEDICATION. WHAT KIND OF RESEARCH WE HAVE TO SUPPORT IT OR WHAT WE DON'T. BUT, ONCE WE HAVE THAT, HERE I WOULD SAY AT THE GOVERNMENT LEVEL OR IN THE REGULATOR LEVEL, IT DOESN'T NECESSARILY MEAN THAT IT'S AVAILABLE FOR THE PUBLIC. SO, I'M GOING TO CLOSE REALLY QUICK TO TALK ABOUT THAT LOGISTICAL GAP AND HELPING EN SURE GROUP WRITES TO THE SECRETARY ABOUT A GAP EXISTS BETWEEN WHAT IS KNOWN WHAT ULTIMATELY MAKES IT TO THE PATIENT. THANK YOU FOR YOUR TIME. DR. PORTS WANTED TO TALK ABOUT A NEW DISCOVERY THE ADA ANNOUNCED RELATED TO SINGLE CARBON METABOLISM THAT ISN'T GETTING TO PATIENTS RIGHT NOW. SO, I DON'T KNOW IF OUR COMMENTS ARE AVAILABLE TO DO THAT. >> DR. SPONG: THAT WILL BE FINE. >> THANK YOU. >> GOOD MORNING, EVERYBODY. MY NAME IS JONATHAN BORTZ. AND I'M FROM ST. LOUIS, AS YOU CAN TELL. SOUTH ST. LOUIS. AND I TRAINED AT WASHINGTON UNIVERSITY. SPENT ABOUT 15 YEARS IN MEDICAL PRACTICE AS AN ENDOCRINOLOGIST. LAND ENDED UP WORKING FOR A PHARMACEUTICAL COMPANY WHERE I BEGAN A CAREER IN DEVELOPING PRODUCTS FOR WOMEN'S HEALTH. PARTICULARLY FOCUSED ON PRENATAL VITAMINS, HEME TINNIC PRODUCTS FOR IRON DEFICIENCY ANEMIA THAT IS A HUGE ISSUE IN WOMEN OF THE CHILD-BEARING YEARS. AND WHAT I'M GOING SAY IS THAT MY INTRODUCTION TO VIEWING NUTRIENT INGREDIENTS, NUTRITIONAL INGREDIENTS AND HOLDING THEM IN THE SAME, STEAM AS MANY OF MY COLLEAGUES HOLD SMALL MOLECULES S REALLY WHAT I ENDED UP DEVELOPING A MEANS OR METHOD TO PURSUE. I GUESS WHAT I'M SAYING IS THAT WE TREAT NUTRIENT INGREDIENTS THE SAME WAY THAT THE AGENCY WOULD LIKE TO SEE SMALL MOLECULES BE TREATED. SO, WE APPROACH IT WITH SCIENTIFIC RIGOR. AND ONE OF THE THINGS THAT I WAS TASKED TO DO IN MY VARIOUS POSITIONS IN INDUSTRY, WAS TO DEVELOP PRODUCTS FOR THE PRESCRIPTIVE MARKET SPECIFICALLY. AND THAT NEEDED TO MEET A PARTICULAR CRITERIA, THAT IS HOW DO WE PERSUADE PHYSICIANS TO PRESCRIBE THOSE PARTICULAR PRODUCTS? WHAT IS THE DIFFERENTIATION? WHY DO THEY NEED TO BE PROVIDE AS OPPOSED TO GOING AND GETTING AN OTC PRODUCT? AND I CAN TELL THAT YOU THAT ENDED UP CREATING A SIGNIFICANT BAR FOR US TO MEET FROM THE STANDPOINT OF WHY THIS IS NECESSARY, WHAT FORM OF THAT PARTICULAR NUTRIENT INGREDIENT WAS NECESSARY TO BE INCORPORATED AND THE FACT THAT EVERY INGREDIENT NEEDED TO EARN ITS PLACE T WASN'T JUST SLAPPED IN AS PART OF A 10, 15, 20 MULTI-VITAMIN INGREDIENT. EVERY INGREDIENT NEEDED TO BE THERE FOR A PARTICULAR REASON. AT THE DOSAGE IN WHICH CLINICAL SCIENCE DETERMINED THAT THAT WAS EFFECTIVE IN EITHER PREVENTING VARIOUS UNWANTED EFFECTS OR ACHIEVING OTHER THERAPEUTIC OBJECTIVES. TO THAT END, WHAT THAT ENDED UP TRANSLATING INTO IS A WORLDWIDE SEARCH FOR INGREDIENTS THAT MET THOSE CRITERIA AND THE SCIENCE THAT SUPPORTED THEIR INCORPORATION IN PRODUCTS. AND I WOULD TELL YOU THAT MY COLLEAGUE NATHAN NELSON WHO DESCRIBED THE FACT THAT THERE HAVE BEEN ADDITIONAL DISCOVERIES IS NOT AN EXAGGERATION FROM THE STANDPOINT THAT FOLATE IS NOT -- FOLIC ACID IS NOT FOLIC ACID IS NOT FOLIC ACID. THE SAME WATHAT IRON IS NOT IRON IS NOT IRON. THERE ARE SIDE EFFECTS AND A VARIETY OF THINGS. FOR EXAMPLE, THERE WAS A STUDY PUBLISHED THAT DEMONSTRATED WHEN WOMEN TAKE FOLIC ACID THAT LANDS INCREASING THE FOLIC ACID PRESENCE IN BREAST MILK. THEY ARE FOLIC ACID PROTEINS BIND FOLIC ACID PREFERENTIAL TOW FOLATE, WHICH IS THE NATURAL FORM AND ENDS UP POTENTIALLY DEPRIVING A NURSING INFANT FROM RECEIVING THE APPROPRIATE AMOUNT OF FOLATE. IT'S NOT KNOWN. THE SAME WAY THAT WE TALK ABOUT FOLIC ACID AS ONE MEMBER OF SINGLE MEMBER CONTAPLITION IN WHICH B12 AND CHOLINE PLAY AN EQUAL ROLE. SO THE INDUSTRY AND THE CONSUMING PUBLIC AND PHYSICIANS DON'T REALLY KNOW AND UNDERSTAND THAT FOLIC ACID AND FOLATE IS REALLY THE TIP OF THE ICEBERG. IF THERE IS ANY ATTEMPT THAT WILL BE MADE TO SAY THAT THIS IS REGULAR GARDEN VARIETY FORTIFIED FOLIC ACID, WHY DO WE NEED A PRESCRIPTION? WHAT IS LITERALLY HAPPENING AND YOU'LL EXCUSE THE CLICHE BUT IT IS LITERALLY THROWING THE BABY OUT WITH THE BATHWATER. SO I THINK FROM OUR STANDPOINT, REPRESENTING INDUSTRY, REPRESENTING THE PRESCRIPTIVE COALITION THAT NATHAN SPOKE ABOUT EARLIER, WE WOULD LIKE TO SAY THAT WE BELIEVE THAT WE CAN PLAY A VERY SIGNIFICANT ROLE IN DEVELOPING THAT GAP OR CLOSING THAT GAP BETWEEN WHAT IS ACK DEMI THINK SCIENCE, INSTITUTIONAL SUPPORTED RESEARCH -- ACADEM IC -- ANSWERS INDUSTRY SEEKING OUT INNOVATIVE AND IMPORTANT WAYS TO HELP MOMS AND THEIR BABIES. THANK YOU. >> DR. SPONG: THANK YOU VERY MUCH. I WANT TO THANK ALL OF OUR PUBLIC COMMENTERS. WE WILL BE POSTING THEIR WRITTEN COMMENTS ON THE WEBSITE. I ALSO WANT TO LET EVERYONE KNOW THAT THIS WILL BE AN ACTIVE PORTION OF EVERY MEETING THAT WE HAVE SO THAT THERE WILL BE TIME FOR OPEN PUBLIC COMMENTS. IN ADDITION, IF PEOPLE DON'T WANT TO OR AREN'T ABLE TO COME TO MAKE A PUBLIC COMMENT, YOU'RE ALWAYS WELCOME TO SEND IN A DOCUMENT FOR PUBLIC POSTING AS WELL. SO WE ENCOURAGE THAT INPUT FROM THE PUBLIC. I WOULD LIKE TO NOW LET US ALL TAKE A BREAK. GET SOME LUNCH. BECAUSE WE HAVE A VERY BUSY AFTERNOON. FOR THOSE WHO ARE HERE, IF YOU REQUIRE A TAXI CAB TO THE AIRPORT, PLEASE STOP BY THE REGISTRATION DESK BEFORE OR AFTER LUNCH IF YOU NEED ASSISTANCE IN ARRANGING A RIDE. AND PLEASE RETURN FOR OUR NEXT PANEL DISCUSSION THAT WILL BEGIN AT 12:30. THANK YOU. >> DR. SPONG: WELCOME. I'D LIKE TO CALL THE MEETING BACK TO ORDER. GOOD TO KNOW WE ARE A VERY ENGAGED GROUP. WE ARE NOW GOING TO BE UNDER A DIFFERENT PORTION OF THAT BULLET FOR TODAY. THIS ONE IS COVER CURRENT EFFORTS TO DISSEMINATE UP-TO-DATE RESEARCH FINDINGS AND OTHER RELEVANT INFORMATION ABOUT THERAPIES TO PREGNANT AND LACTATING WOMEN WHO MAY NEED THEM. WE WILL AGAIN HAVE THE SAME FORMAT WHERE WE HAVE THREE PRESENTATIONS FOLLOWED BY DISCUSSION BY THE PANEL AND THEN DISCUSSION BY THE ENTIRE ROOM. WE'LL BEGIN BY HEARING FROM MICHAEL GREENE WHO WILL GUS FROM A HEALTH CARE PROVIDER PERSPECTIVE AND THEN JAMIE ZAHLAWAY BELSITO WILL GIVE US A PATIENT'S POINT OF VIEW AND ATHENA KOURTIS WILL TELL US HOW THE CDC WORKS TO DISSEMINATE INFORMATION TO THE PUBLIC. DR. GREEN, YOU'RE FIRST. >> DR. GREENE: THANK YOU VERY MUCH FOR INVITING ME TO SPEAK. I APPRECIATE THE OPPORTUNITY. AND ON THIS OCCASION, I'M WARING MY HAT AS A FELLOW OF THE AMERICAN COLLEGE OF OBSTETRICS AND GYNECOLOGIST WE ARE THE PROFESSIONAL AGENCY THAT REPRESENTS OR THE PROFESSIONAL ORGANIZATION THAT REPRESENTS ABOUT 35-40,000 PLAGOBGYNs IN THE UNITED STATES. WE PROVIDE -- PRACTICING -- WE PROVIDE MOST OF THE OBSTETRICAL CARE TO WOMEN IN THE UNITED STATES. SO, IN TERMS OF DISCLOSURES, THESE ARE OTHER ENTITIES THAT PAY ME MONEY FOR SERVICES RENDERED. AS SOMEBODY WAS SAYING EARLIER, YOU WISH YOU COULD CHANGE YOUR SLIDES THE DAY AFTER BECAUSE YOU ALREADY SEEN THIS SLIDE ONCE OR TWICE SO FAR. FURTHERMORE, THIS IS BRINGING A MESSAGE PREACHING TO THE CHURCH CHOIR EVERYBODY KNOWS HOW MANY MEDICATIONS WOMEN ARE TAKING DURING PREGNANCY. AND NOBODY IS SUGGESTING THAT A SUBSTANTIAL PERCENTAGE OF THOSE ARE UNNEEDED OR INAPPROPRIATE. THIS SOOTHER COMPILATION. THIS WAS REVIEW OF A NUMBER OF STUDIES THAT WERE PUBLISHED IN THE MEDICAL LITERATURE. AGAIN, YOU CAN SEE BY CATEGORY ANALGESICS, ANTACIDS, NASAL MEDICATIONS, AND WHAT NOT, ANTIMICROBIAL, LAXATIVES, ET CETERA. ANY TIME, FIRST, SECOND AND THIRD TRIMESTER. SO EXPOSURE TO MEDICATIONS DURING PREGNANCY IS FAIRLY UBIQUITOUS. THIS IS THE COMMITTEE OPINION FROM THE AMERICAN COLLEGE ON ETHICAL ISSUES REGARDING THE INCLUSION OF PREGNANT WOMEN. AND IT'S BEEN SAID BEFORE, AND I'LL MENTION IT ONCE AGAIN, THAT WE NEED TO SORT OF CHANGE OUR MIND-SET FROM THE IDEA OF PROTECTING WOMEN FROM RESEARCH TO PROTECTING WOMEN THROUGH RESEARCH. IT WAS IN THIS COMMITTEE OPINION THAT THE COLLEGE RECOMMENDED THAT PREGNANT WOMEN IN RESEARCH TRIALS, SHOULD BE DEFINED AS SORT OF TECHNICALLY COMPLEX OR SCIENTIFICALLY COMPLEX RATHER THAN VULNERABLE. VULNERABLE IS JUST BAD CONNOTATIONSES. AND SCIENTIFICALLY COMPLEX IS PROBABLY A MORE PRECISE DENOTATION. MATERNAL AND FETAL RISKS ARE DEEPLY INTERCONNECTED, GENERALLY SPEAKING AS WE ALL KNOW, WHAT IS BEST FOR THE MOTHER IS USUALLY ALSO WHAT IS BEST FOR THE FETUS. AND THE IDEA OF CONFLICT BETWEEN WHAT IS BEST FOR THE MOTHER AND WHAT IS BEST FOR THE FETUS IS MORE GROUNDS FOR A LENGTHY DISCUSSION THAN IT IS COMMONLY DISCUSSED AMONG OBSTETRICIANS BECAUSE THAT'S A RARELY A COMPETING INTEREST THAT WE HAVE TO ADDRESS. NOT NEVER, BUT IT'S PRETTY RARE. AND CONSIDERATION OF ENROLLING PREGNANT WOMEN IN RESEARCH REQUIRES BALANCING POTENTIAL RISK OF FETAL HARM WITH THE POTENTIAL FOR BENEFIT AND THE IMPORTANCE OF THE INFORMATION TO BE GAINED ON THE HEALTH OF WOMEN AND FETUSES. ANOTHER IMPORTANT ISSUE THAT FREQUENTLY GETS FORGOTTEN HERE IS THAT WHAT IS THE DOWNSIDE RISK TO THERAPEUTIC NEEDLISM? NOT EVERYBODY WILL DO WELL WITH WHATEVER THEIR UNDERLYING MEDICAL DISORDER IS IF THEY ARE NOT TREATED AT ALL. THOUSANDS OF WOMEN ARE ON ANTIEPILEPTIC DRUGS AND OTHER DISORDERS THAT NEED TO BE TREATED. THIS IS GUIDELINES FOR PERINATAL CARE, WHICH IS UPDATED PERIODICALLY AND PRODUCED IN COOPERATION BETWEEN THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS AND THE AMERICAN ACADEMY OF PEDIATRICS AND IT IS UPDATED PERIODICALLY. THIS IS THE MOST RECENT VERSION, WHICH IS NOT THAT RECENT. IT'S 2012. BUT IT HASN'T BEEN REVISED YET. AND YOU CAN SEE AS PART OF PRECONCEPTION CARE, THE GUIDE RECOMMENDS THAT OBSTETRICIANS DISCUSS WITH THEIR PATIENTS MEDICATIONS, PRESCRIPTION AND NON PRESCRIPTION AS PART OF PRECONCEPTION CARE AND COUNSELING. SEPARATELY, ENVIRONMENTAL AND OCCUPATIONAL EXPOSURES, ET CETERA. FAMILY HISTORY, THERE IS A LOT OF GROUND TO COVER IN TERMS OF PRECONCEPTION CARE IF YOU'RE THINKING OF THIS OCCURRING IN THE SETTING OF A ONE-HOUR CONSULTATION. THE FACT OF THE MATTER IS, AS WE ALL KNOW, THAT 50% OF ALL PREGNANCIES IN THE UNITED STATES ARE UNPLANNED. AND THE TRUTH OF THE MATTER IS, THAT MOST WOMEN WHO SHOW UP IN OUR OFFICES IN THE FIRST TRIMESTER, HOPEFULLY THEY SHOW UP IN THE FIRST TRIMESTER, HAVE ALREADY BEEN ON THESE MEDICATIONS OR HAVE BEEN EXPOSED TO THESE POTENTIAL EXPOSURES THROUGH THE CRITICAL PERIOD OF ORGANOGENESIS BY THE TIME WE SEE THEM FOR THE FIRST TIME. IN MANY SITUATIONS, THAT HORSE IS OUT OF THE BARN. IN THE FIRST TRIMESTER AND PRESUMABLY AT THE FIRST PRENATAL VISIT, THE OBSTETRICIANS ARE RECOMMENDED TO COVER THIS GROUND, NUTRITION AND WEIGHT GAIN, AVOIDANCE OF FOOD-BORNE INFECTIONS, EXERCISE, DENTAL CARE, NAUSEA AND VOMITING. VITAMIN AND MINERAL TOXICITY INCLUDING MERCURY AND FISH IN TAKE. AVOIDANCE OF TERAT JENS. AIR TRAVEL, PRENATAL DIAGNOSIS AND THIS WAS PREZIKA. THE POINT I'M TRYING TO MAKE IS THAT THERE IS A LOT ON THE PLATE OF THE AVERAGE OBSTETRICIAN. IT'S A LOT TO DELIVER WITHIN THE CONTEXT OF A ONE-HOUR PRENATAL VISIT. AND, IT'S A VERY BROAD WATERFRONT TO COVER AND A LOT OF MATERIAL FOR YOUR AVERAGE PRACTITIONER TO ASSIMILATE AND BE ABLE TO HELP HIS OR HER PATIENT UNDERSTAND. AND DR. BIANCHI WAS VERY INSTRUMENTAL IN A MAJOR ADVANCE IN PRENATAL DIAGNOSIS, WHICH ALSO THREW OBSTETRICIANS FOR A LOOP BECAUSE IT WAS A BRAND NEW TECHNOLOGY. MOST OF US, WHEN WE WERE IN COLLEGE AND MEDICAL SCHOOL, THIS TECHNOLOGY HADN'T BEEN INVENTED YET. VERY FEW PEOPLE UNDERSTOOD IT VERY WELL AND IT WAS A HUGE CHALLENGE AND SCRAMBLE FOR OBSTETRICIANS TO UNDERSTAND THE NEW TECHNOLOGY OF THE MATERNAL CIRCULATION AS A PRENATAL DIAGNOSTIC SCREENING OR PRENATAL SCREENING TECHNIQUE. AND THAT IS JUST AN EXAMPLE THAT OCCURRED AFTER THE 2012 GUIDELINES CAME OUT. AND THESE KINDS OF THINGS COME OUT PERIODICALLY FOR US EVERY FEW YEARS. THE CDC IS A VERY IMPORTANT RECOMMENDATION ON VACCINATIONS. THEY CHANGE OVER TIME AS A RESULT OF THE DIPHTHERIA OR PERTUSSISES OUTBREAK IN THE UNITED STATES SEVERAL YEARS AGO. THEY RECOMMENDED DTP AND WE NOW DO THAT. SO, THERE IS A LOT OF GROUND FOR AN OBSTETRICIAN TO COVER DURING THE TIME ALLOTTED AND IT'S A LOT OF SCIENTIFIC WATERFRONT FOR AN OBSTETRICIAN TO UNDERSTAND AND MASTER. AND ONE OF THE THINGS THAT WE WERE TALKING ABOUT EARLIER WAS THAT ALL OF THESE WARN FRAGS COME OUT, WHATEVER IT IS ABOUT, THE LAST LINE IS ALWAYS, DISCUSS THIS WITH YOUR DOCTOR. WELL, IN FAIRNESS, YOUR DOCTOR MAY NOT REALLY BE AN EXPERT ON THIS. AND THEREIN LIES THE RUB. AND THAT'S HOW YOU WIND UP WITH THE PER VERBIAL SIX DOCTORS GIVING YOU SEVEN OPINIONS. THEY MAY NOT BE EXPERT AND THE OTHER THING IS THAT THE STATE-OF-THE-ART AND THE STATE OF THE KNOWLEDGE MAY NOT BE SUFFICIENTLY PRECISE THAT EVERYBODY HAS THE SAME PERCEPTIONS. AND THEN FINALLY, MOST PREGNANT WOMEN THESE DAYS GET THEIR INFORMATION FROM THE INTERNET. AND A SUBSTANTIAL PERCENTAGE OF MY OFFICE HOURS EACH WEEK WHEN I'M IN THE OFFICE, IS OFTEN SPENT DISPELLING MISINFORMATION THAT PATIENTS HAVE PICKED UP ON THE INTERNET. AND I ALWAYS TELL MY PATIENTS IT'S WONDERFUL TO READ THIS STUFF, JUST DON'T BELIEVE IT UNTIL WE HAVE HAD A CHANCE TO TALK ABOUT IT. SO, I THINK THAT IF THERE WERE SOME INTERDISCIPLINARY WAY OR INTERAGENCY ACTIVITY THAT WOULD BE OF BENEFIT TO THE AMERICAN PREGNANT PUBLIC, IT WOULD BE SOME INTERNET-BASED RESOURCE THAT WOULD BE PUBLICLY-AVAILABLE, FREELY-AVAILABLE, THAT WOULD BE RELIABLE AND AUTHORITATIVE, THAT WOULD BE CURRENT AND UP-TO-DATE AND THAT IT WOULD BE EVIDENCE-BASED. AND EVIDENCE-BASED IS TERRIBLY IMPORTANT HERE. AND WE DON'T ALWAYS HAVE SOLID TRACK RECORD OF BEING EVIDENCE-BASED IN SOME OF OUR PUBLICLY-AVAILABLE WEBSITES. SO, WITH THAT, I WILL SUM UP. THANK YOU. [ APPLAUSE ] >> THANK YOU VERY MUCH. SO, I'D LIKE TO TAKE A MOMENT TO SAY THANK YOU TO KAY SHUBERT FOR HAVING GOTTEN ME INVOLVED IN THIS TASK FORCE B A YEAR AGO I WAS THRILLED TO SPEAK AT THE BRIEFING THAT HIGHLIGHTED THE NEED FOR THIS TASK FORCE AND HERE WE ARE. SO I'D ALSO LIKE TO TAKE A MOMENT AND SAY THANK YOU TO CATHERINE AND EVERYONE ELSE HERE. I WANT TO SAY THANK YOU TO DR. GREENWHO SOMEWHAT SUMMARIZED A LOT OF MY FOLLOWING SENT NANCY WE'LL TAKE A LOOK AT HERE. I THINK WE ARE ALL SPEAKING THE SAME LANGUAGE. IT'S BEEN VERY CLEAR. I WON'T SAY ANYONE NEEDS A TRANSLATOR FOR MY BAD ACCENT. TALK TO ME AFTER. THE PATIENT PERSPECTIVE, IN MY PATIENT PERSPECTIVE, AS THE ADVOCACY CHAIR FOR THE NATIONAL COALITION ON MATERNAL MENTAL HEALTH, AND MY OWN JOURNEY AS HAVING BEEN A MOM WHO FOUND MYSELF IN A WHIRLWIND OF WHAT IS GENERALLY TERMED POSTPARTUM DEPRESSION, WHICH WE ARE CALLING MATERNAL MENTAL HEALTH ISSUES THAT THE POINT IN TIME. MATERNAL MENTAL HEALTH ISSUES CAN OCCUR WITH NO PRIOR HISTORY OF ANY MENTAL HEALTH CHALLENGES DURING PREGNANCY AND POST. IT IS SOMEWHAT PREVENTIBLE. IT'S SOMETHING THAT WE SEE SOME OVERLAP WITH A TASK FORCE LIKE THIS AND THE AGENCIES THAT ARE IN THIS ROOM ON SOMETHING THAT WE ARE LOOKING TO MOVE MORE EDUCATION INFORMATION ON AND THE PROXIMATE PERCENTAGE OF FOLKS IS ROUGHLY 20% OF ALL PREGNANT MOMS. AND THAT IS KNOWN. SO, YOU CAN TAKE THAT INFORMATION AND PROBABLY KASICATED IT UPWARDS TO ABOUT 30%. SO, WHAT I FOUND IN MY OWN JOURNEY AND SPEAKING WITH MOMS ALL ACROSS THE COUNTRY AS WE SPOKEN ABOUT THE MENTAL HEALTH ASPECT OF THIS OF BEING PREGNANT AND NURSING, WAS THE FACT THAT MOMS ARE GENERALLY TAKEN OFF THEIR MEDS. AND PART OF THE DISCUSSION AND THIS CAN OVERLAP WITH SOME OF WHAT WE ARE SEEING WITH OPIOID EPIDEMIC AS WELL IS THE MOVE TO SELF MEDICATE. AND THIS IS A CO-MORBIDITY DUAL DIAGNOSIS THAT WE ARE SEEING MORE AND MORE OF, UNFORTUNATELY. I WOULD ALSO SAY THAT LACK OF ACCESS TO HEALTH CARE HAS ALSO CREATED THIS BARRIER. WE KNOW THAT AT LEAST FROM MY UNDERSTANDING, 60 DAYS POST BIRTH IF YOU'RE ON MEDICAID, MOM IS THEN TAKEN OFF OF THAT PROGRAM. AND I COME FROM A STATE THAT WE DON'T HAVE THESE ISSUES. WE HAVE THE MODERN DAY OBAMACARE. SO, THESE ARE ISSUES THAT ARE KASICATEDDING ACROSS THE NATION AS -- CASCADING -- OF BARRIERS AND LACK OF ACCESS. SOMETHING WE ALSO SEE AND MY GIRLFRIENDS AND I USE THIS TERMINOLOGY OF DOCTOR SHOPPING. AND THAT'S BECAUSE WHICH DOCTOR IS GOING TO SAY YES, OKAY, SURE, YOU WANT TO KEEP ON YOUR LEXA PRO OR PROZAC OR WHAT HAVE YOU? THAT'S FINE. WE'LL MONITOR YOU. AND DOCTOR GREENEVEN SAID, YOU CAN GET SIX DOLLARS THE SAME QUESTION AND YOU GET SEVEN ANSWERS. THIS IS THE CONUNDRUM WHERE THE PATIENT BECOMES A PROBLEM BECAUSE IT ENDS UP GOING TO WHO IS GOING TO GIVE ME THE ANSWER THAT I WANT? AND THAT WILL ISN'T INCONSISTENT, I DON'T KNOW WHAT IS. I CAN EVEN EXTRAPOLATE BEING IN THE NORTH SHORE OF BOSTON. I CAN GET ONE ANSWER AT THE BIRTHING HOSPITAL BUT IF I WENT INTO BOSTON, I COULD GET A DIFFERENT ANSWER. SO THIS IS ESPECIALLY IF YOU'RE IN AN AREA OF ACCESSIBILITY. THIS IS GENERALLY WHAT TENDS TO HAPPEN. AND IT ALSO COMES DOWN TO THE DOCTORS WILLINGNESS AND ABILITY TO A, BE EDUCATED AND B, MONITOR THE PATIENT THROUGHOUT THE PROCESS AND BE INVOLVED IN THAT CONVERSATION OF AGAIN IN WANT TO WHAT I'M SPEAKING ABOUT, MENTAL WELLNESS. WHAT CAN THE TASK FORCE DO? I'M GOING TO CONTINUE TO REITERATE A LOT OF WHAT WE HAVE DISCUSSED AND THAT IS REALLY HELPING WOMEN ACCESS EVIDENCE-BASED TREATMENTS THAT ARE AVAILABLE. THAT LITTLE THING THAT WE ARE ALL LOOKING AT IN OURANDS THROUGHOUT THE PAST COUPLE OF DAYS, THAT SMARTPHONE THAT ANDROID, TO ME IS ON 3:00 IN THE MORNING WHEN KNOWN IS AWAKE BUT YOU AND A SCREAMING CHILD. WHICH THEY GENERALLY SCREAM AT THAT TIME. I DON'T KNOW WHY. AND THAT'S YOUR PHONE. WHEN YOU'RE LOOKING FOR, WHY IS MY BABY CRYING? WHAT CAN I DO TO HELP SOOTHE IT? WHY AM I FEELING LIKE SOMETHING IS NOT RIGHT WITH ME AND I'M GOING BACK TO THE MATERNAL MENTAL HEALTH PIECE. OR CAN I TAKE THIS MEDICATION? THAT REALLY TENDS TO BE WHERE YOUR FRIEND ON YOUR HAND. NOW DURING THE BREAK, I TOOK A LOOK AT BREASTFEEDING AND MEDICATION ON APPLICATIONS ON THE iPHONE. THERE IS FOUR OF THEM OUT THERE. ONE IS LACK MED. WHICH IS GREAT. THE OTHER IS THE STEP UP TO THAT WAS TEXAS. I CAN'T THINK OF THE DOCTOR'S NAME THAT PUT THE INFORMATION TOGETHER. THANK YOU. TOM. YES. HONESTLY EVEN FOR MYSELF AND IN TRYING TO FIGURE OUT WITH THE BLINDFOLD ON WHERE AM I GOING WITH MEDICATION, THIS IS THE GUY WE ALL WENT TO WAS TOM HAIL. AND SO, EVEN HIS APPLICATION IS STILL AVAILABLE TO DOWNLOAD ON THE iPHONE. SO WHAT DOES THAT MEAN? THAT'S INCONSISTENCY OF INFORMATION THERE BUT PEOPLE WILL PICK AND CHOOSE WHICH APPLICATION THEY WANT TO DOWN EXPLODE WHAT INFORMATION THEY ARE GOING TO TAKE AS BIBLE. AND AGAIN, I'LL POINT TO THE GENERATIONAL ISSUES. I THINK WE WERE ABLE TO TOPICALLY ADDRESS TODAY IS, IS THE GENERATION-X? OR AM I GOING TO BE MORE LEARY TO TAKE EVERYTHING ON FACE VALUE THAN I'M READING ON THE COM PARITY BECAUSE MAYBE THERE NEEDS TO BE MORE RESEARCH BUT IS SOMEONE THAT IS 18 YEARS OLD LOOKING ON THEIR HANDHELD DEVICE THAT IS SAYING, WELL, THIS INFORMATION IS IN AN APPLICATION, IT HAS TO BE TRUE. THIS HAS TO BE THE BIBLE. HOW DO WE GET CONSISTENT INFORMATION INTO PEOPLE'S HANDS? BECAUSE AT THE END OF THE DAY, ESPECIALLY TALKING ABOUT LACK OF ACCESS TO HEALTH CARE, SOMETIMES WEBMD ENDS UP BEING WHO IS PROVIDING YOU YOUR HEALTH CARE AND WE NEED TO TAKE A LOOK AT HOW TO CONSOLIDATE ALL OF THE INCREDIBLE WORK THAT IS BEING DONE AT ALL OF THE AGENCIES AND CREATING THAT CONSOLIDATED MESSAGE. SCALEABLE PROGRAMS EVIDENCE BLAZE IS SOMETHING THAT DR. NANCY, IF ANYONE KNOWS HER IN THE PSYCHIATRIC -- IN THE PERINATAL PSYCHIATRIC SPACE AS WELL AS DR. TIFFANY WHO IS AN OBGY! THEY RUN THE PATH FOR MOMS PROGRAM IN MASSACHUSETTS WHICH GIVES REALTIME PSYCHIATRIC ASSISTANCE TO PROVIDERS WHO MIGHT NOT BE VERSED IN HOW TO WORK WITH A PATIENT WHO NEEDS AND REQUIRES A PSYCHIATRIC DRUG DURING PREGNANCY AND/OR BREASTFEEDING. LIKE TAKE A LOOK AT PROGRAMS THAT ARE ALREADY OUT THERE THAT ARE WORKING. THE NEED -- AND THIS IS SOMETHING THAT SO MANY MOMS ARE SAYING IS, PROVIDER TRAINING AND SUPPORT. I SAT THERE WITH MY DOCTOR AND SAID, GEEZ, CAN I TAKE THIS SSR! I DON'T KNOW. YOU'RE GOING TO HAVE TO FIGURE THAT OUT WITH THE PSYCHE AND THEN YOU SAY TO THE PSYCHE, AM I ABLE TO TAKE THIS? I GUESS SO. LET ME TAKE A LOOK AT HOW DID IS THIS CODED. THAT CODE THERE. I'M NOT INTO THE ALPHABET SOUP AND THE NUMBER SOUP EITHER BUT I JUST REMEMBER TAKING A LOOK AT THIS AND SAYING IT SAYS I SHOULD BE ABLE TO NURSE. AND THAT IS A TOUGH SPACE TO BE IN AT THE BREASTFEEDING PLACE. I WANT TO SPEAK TO THE BREASTFEEDING FORA A MOMENT BECAUSE WITH RESPECT TO MATERNAL MENTAL ILLNESS. IF A MOM HAS CHOSEN NOT NURSE, THAT'S GREAT. THE MOM'S CHOICE. REGARDLESS OF ANY MENTAL HEALTH ISSUES. I'M JUST GOING DO PUT THAT OUT THERE F A MOM IS SUFFERING FROM ANY PERINATAL PSYCHIATRIC OR MENTAL HEALTH CHALLENGES AND NURSING IS THE ONLY THING THAT IS GOING WELL FOR THEM, AND NOW YOU'RE PUTTING THEM ON A MED AND SAYING YOU CAN NO LONGER NURSE THE BABY? THAT IS LITERALLY PUTTING ACID INTO THE WOUND. AND PUTTING WOMEN IN A POSITION THAT THEY HAVE NO CHOICES IS REALLY LIKE CORNERING THE INDIVIDUAL INTO HAVING ABSOLUTELY NO CHOICES FOR HOW THEY ARE GOING TO TAKE CARE OF THEIR BABY OR THEMSELVES. AND DO I TAKE CARE OF MYSELF? WHAT IS IT? YOU'RE IN THE AIRPLANE AND IF WE LOSE AIR PUT THE MASK ON AND TAKE CARE OF THE BABY. ABSOLUTELY BUT SOMETIMES AND ESPECIALLY IN THE EARLY MONTHS, YOU CAN'T NECESSARILY -- THERE IS VALIDITY TO SAY YOU CAN'T SEPARATE THE BABY FROM THE MOM. SO I WANT TO RAISE THAT AS WELL. I WANT TO BRING THE TASK FORCE TO BRING ATTENTION TO THE FACT THAT FEW DRUGS HAVE BEEN ADEQUATELY EVALUATED IN PREGNANCY AND LACTATION. SO TO REITERATE WHAT I JUST SAID, IT LEAVES THE PATIENT IN LIMBO AND THAT'S NOT TAKING CARE OF THE MOM. WE CAN RECOMMEND ON LINE TOOL THAT HOLDS ALL AGENCY INFORMATION RELATED ON MEDICATION SAFETY. SO, THIS PIE IN THE SKY CLEARING HOUSE DATABASE OF RELEVANT, ADEQUATE INFORMATION THAT I'M NOT LOOKING AT ONE THING WITH THE CDC AND ANOTHER THING WITH NIH AND OWH IS SOMETHING ELSE. THAT THIS IS CLEAR AND CONSISTENT DELIVERABLE INFORMATION. A ONE-STOP-SHOP THAT IS ALSO BEING CASCADED TOUT YOUR REGIONS IN RESPECTS TO THE REGIONS OF GOVERNMENT. AND I THINK THAT THIS IS SOMETHING THAT REALLY NEEDS TO BE TAKEN A LOOK AT. YOU CAN PUT OUT THE -- WE CAN PUT OUT WHATEVER WE WANT IN THESE WEBSITES BUT UNLESS THAT INFORMATION IS DISSEMINATED OUT TO THE REGIONS AND THEN DISSEMINATED TO THE STATES AND CASCADED DOWN TO THE PEOPLE THAT ARE BOOTS ON THE GROUND, IT'S NOT GOING TO WORK. AND MOMS AGAIN ARE ALWAYS GOING TO BE LOOKING FOR THAT INFORMATION. SO, AGAIN, THIS WAS A MENTAL HEALTH PERSPECTIVE ON THINGS. BUT I WOULD SAY IT RESONATES ACROSS-THE-BOARD. IF PEOPLE NEED MEDICATION TO MANAGE THEIR HEALTH AND WELLNESS, THAT IS WHAT THE TAKE AWAY IS. AND WHERE THAT LEVEL OFY IS VARIATEY IS, I'M NOT SURE HOW THIS TASK FORCE WILL GO BUT WE NEED TO BE ABLE TO PUT MOMS FIRST AND I THANK YOU FOR THE OPPORTUNITY TO SPEAK ABOUT THIS PATIENT PERSPECTIVE. AND I ALSO FOR THOSE OF YOU WHO ARE INTERESTED, I DID PUT TOGETHER SOME READING MATERIAL TO GIVE YOU DIFFERENT PERSPECTIVES OF WHAT MOMS EXPERIENCES WERE ACROSS THE UNITED STATES DURING PREGNANCY AND POST. THANK YOU. >> GOOD AFTERNOON. I'M HAPPY TO BE ABLE TO HAVE THE OPPORTUNITY TO PROVIDE SOME MORE INFORMATION ABOUT HOW CDC APPROACHES DISSEMINATING SCIENCE AND WE HAVE THESE GOALS HOW TO TRANSLATE DATA. AND HOW TO COMMUNICATE THIS WITH OUR PUBLIC EITHER GENERAL PUBLIC OR THE PROVIDERS WHO NEED TO BE INFORMED ABOUT NEW GUIDANCE OR NEW DATA. AND I WANT TO THANK YOUR COMMUNICATIONS DEPARTMENT BECAUSE THEY PROVIDED A LOT OF THESE SLIDES. SO WE ARE GOING TO BRIEFLY GO OVER COMMUNICATION SCIENCE AND THE APPROACH AND THE CHALLENGES AND STRATEGIES AND GOALS THROUGH THE SCIENCE FRAMEWORK THAT CDC DEVELOPED. SO COMMUNICATION SCIENCE IS THE STUDY AND USE OF COMMUNICATION STRATEGIES TO INFORM AND INFLUENCE INDIVIDUAL DECISIONS THAT ENHANCE HEALTH. AND WE BELIEVE STEPS IN APPROACHING THESE SHOULD BE THAT THE COMMUNICATION SHOULD BE CUSTOMER-CENTERED AND THAT MEANS WE NEED TO UNDERSTAND WHO OUR AUDIENCE IS. BE IT THE GENERAL PUBLIC, PREGNANT WOMEN, LACTATING WOMEN, OR THE PROVIDERS WHOICATOR TO THESE WOMEN. AND THIS IS SCIENCE BASED DRAWING FROM THE WORK OF SCHOLARS AND PRACTITIONERS AND ALSO USING MULTIPLE BEHAVIORAL AND SOCIAL LEARNING THEORIES AND MODELS TO ADVANCE AND DEVELOP COMMUNICATION MESSAGES AND IDENTIFY STEPS TO INFLUENCE CHANGES IN BEHAVIOR AND ATTITUDES. AND WILL BE ABLE TO ACHIEVE ITS GOAL AND GENERATE TRUST. AND COMMUNICATION NEEDS TO BE HIGH-IMPACT AND WHAT DOES THAT MEAN? IT MEANS THE COMMUNICATION NEEDS TO BE TIMELY AND NEEDS TO BE ACCURATE AND ALSO NEED TO BE RESPECTFUL AND INCREDIBLE AND CONSISTENT. AND THIS SLIDE HIGHLIGHTS THE STEPS IN THE DEVELOPMENT AND DISSEMINATION AND ULTIMATELY EVALUATION OF A HEALTH COMMUNICATION MESSAGE. AND STRATEGIES THAT INFORM AND INFLUENCE INDIVIDUAL DECISIONS SO ULTIMATELY WE ENHANCE HEALTH. SO STEPS ARE TO REVIEW BACKGROUND INFORMATION TO DEFINE THE PROBLEM. AND SET THE COMMUNICATION OBJECTIVES. WHAT DO WE WANT TO ACCOMPLISH. THE NEXT STEP IS ANALYZING SEGMENTED TARGET AUDIENCES. WHO DO WE WANT TO UNDERSTAND POOR AUDIENCES AND THEN DEVELOP AND PRETOAST THE MESSAGE CONCEPTS. WHAT DO WE WANT TO SAY? SELECT COMMUNICATION CHANNELS, WHERE DO WE WANT TO SAY IT? AND THEN SELECTED, CREATE AND PRETEST MESSAGES AND PRODUCTS, IN OTHER WORDS HOW WE WANT TO SAY IS IT AND THEN FINALLY DEVELOP THE PROMOTION PLAN, AND PRODUCE THE MESSAGE AND IMPLEMENT COMMUNICATION STRATEGIES. GETTING IT OUT THERE AND THEN FINALLY CONDUCT OUTCOME AND IMPACT EVALUATION. HOW WELL DID WE DO? SO HERE ARE THE CHALLENGES OUR CDC IS COMMUNICATING THE SCIENCE. WE HAVE THE CONSUMER-FACING WEBSITE WITH LOTS OF SPECIFIC TOOLS AND INFORMATION FOR PROVIDERS SUCH AS FOR EXAMPLE FROM OUR DIVISION WE HAVE PROGRAMS, PREGNANCY SURVEILLANCE SYSTEM, THAT SEE GUIDANCE THAT WE MENTIONED YESTERDAY, THE TEEN PREGNANCY, AND SO ON. WE HAVE SCIENTIFIC PUBLICATIONS. MMWR, THE BEST KNOWN AND OTHER JOURNALS INCLUDING JOURNAL OF EMERGING AND INFECTIOUS DISEASES AND THE CHRONIC DISEASE PREVENTION JOURNAL AND OTHERS. WE HAVE SOCIAL MEDIA, WHICH ARE CHANNELS THAT ALLOW US TO QUICKLY DISSEMINATE IMPORTANT INFORMATION ESPECIALLY IN EMERGENCY SITUATIONS SUCH AS WITH ZIKA. AND OTHER EDUCATIONAL MATERIALS, PAMPHLETS, HAND OUTS, POSTCARDS, BROCHURE, MATERIALS FOR PROVIDERS, APPS FOR PROVIDERS. THERE ARE SEVERAL EXAMPLES OF THAT. AS FOR THE PUBLIC WE ALSO STARTED TO DEVELOP SOME OF THESE. PRESENTATIONS AT CONFERENCES AND PUBLIC AFFAIRS MEDIA OUTREACH. AND HERE IS SOME SAMPLES OF MATERIALS THAT A FEW EXAMPLES OF CDC PANELS INCLUDING MATERIALS FOR PROVIDERS. YOU SEE ON THE TOP PANEL SEVERAL OF THEM, MEDICAL CONTRACEPTIVE USE. YOU SEE EXAMPLE OF THE MMWR. A WEBSITE FEATURE ON BIRTH DEFECTS AND AD FOR TWITTER CHAT AT CDC PARTICIPATED WITH REGARDS TO THE NATIONAL INFERTILITY AWARENESS WEEK. AND HERE IS SOME MORE FEATURES INFO GRAPHICS FOR THE GENERAL PUBLIC. YOU SEE ON THE LEFT SIDE HOW TO AVOID LISTERIA. IN THE MIDDLE YOU SEE INFORMATION ABOUT FLU SHOT IN PREGNANCY AND THEN YOU SEE ALSO A WEB THAT PROMOTES TREATING FOR CAMPAIGN AND THEN THE PERINATAL QUALITY COLLABORATIVES. THE MMWR I'M SURE MOST OF YOU ARE FAMILIAR WITH THE MORBIDITY AND MORTALITY WEEKLY REPORT OFTEN CALLED THE VOICE OF CDC. IT'S VIEWED BY ABOUT A MILLION PERSONS PER MONTH AND WIDELY CITED IN SCIENTIFIC LITERATURE AS THE PREMIER LEGAL FOR CDC TO COMMUNICATION INFORMATION ABOUT NEW HEALTH THREATS AND PRESENTED RESULTS ABOUT INVESTIGATIONS IN A TIMELY MANNER AND PUT OUT GUIDANCE FOR PROVIDERS WE PRODUCE. SO, SOME STRATEGIES FOR COMMUNICATION IN ADDITION TO OUR HEALTH COMMUNICATIONS AND PUBLICATIONS. WE CANNOT EMPHASIZE THE IMPORTANCE OF PARTNERSHIPS AND COLLABORATIONS BE IT WITH OTHER PROFESSIONAL ORGANIZATIONS WITH OTHER FEDERAL AGENCIES W A NON FEDERAL SECTOR, ACADEMIC INSTITUTIONS AND INDUSTRY AND HEALTH MARKETING WHICH IS USED QUITE A BIT IN OUR COMMUNICATING APPROACHES. AND THEN FINALLY I WANT TO END WITH THE CDC SCIENCE IMPACT FRAMEWORK WHICH IS THE THEORETICAL FRAMEWORK YOU USE FROM SCIENCE TO TRANSLATION OR HOW YOU EFFECT CHANGE IN THE POLICY AND THE PRACTICE LEVEL. SO THE FRAMEWORK HAS FIVE LEVELS OF INFLUENCE HERE. DISSEMINATING SCIENCE, CREATING AWARENESS, CATALYZING ACTION, EFFECTING CHANGE AND SHAPING THE FUTURE ARE THE FIVE LEVELS. AND THERE ARE A NUMBER OF KEY INDICATORS AT EACH LEVEL THAT CAN BE IDENTIFIED AND TRACKED. FOR EXAMPLE, KEY INDICATORS FOR DISSEMINATING SCIENCE MAY INCLUDE PUBLICATIONS, PRESENTATIONS AT CONFERENCES OR SOCIALITY MEDIA, WEB, PRINT AND OTHER COMMUNICATIONS. CREATING AWARENESS MAY INCLUDE AWARDS, INFORMATION SHARING&AMONG PROFESSIONAL ASSOCIATIONS AND DIALOGUE IN THE SCIENTIFIC COMMUNITY. CATALYZING ACTION MAY INCLUDE RESULTING PARTNERSHIPS, TECHNOLOGY CREATION, OR CONGRESSIONAL HEARINGS, FOR EXAMPLE. EFFECTING CHANGE MAY INCLUDE RESULTING CAPACITY BUILDING, CHANGES IN PRACTICE OR POLICY OR OTHER SOCIETAL IMPACTS. AND SHAPING THE FUTURE MAY INCLUDE NEW STRATEGIES, NEW HYPOTHESES, PROGRAMS AND INITIATIVES TO BE CONSIDERED THAT RESULT IN PROGRESS AND QUALITY IMPROVEMENT. AND IN THE END, POSITIVE HEALTH OUTCOMES ARE THE ULTIMATE GOAL. AND I THINK I'M GOING TO END THERE AND THANK YOU AGAIN FOR THE OPPORTUNITY. [ APPLAUSE ] >> DR. SPONG: THANK YOU VERY MUCH TO OUR PRESENTERS AS WE MOVE TO THIS PANEL DISCUSSION REGARDING DISSEMINATION OF RESEARCH FINDINGS AND AYE LIKE TO INVITE OUR OTHER PANEL MEMBERS TO ALSO PROVIDE SOME OF THEIR THOUGHTS AND THEN WE'LL OPEN UP FOR GENERAL DISCUSSION. >> THANK YOU VERY MUCH. COMMENT ABOUT THE TREATING FOR TWO INITIATIVE WHICH MARCH OF DIMES HAS BEEN PART OF ALONG WITH CDC AND RT I AND THAT INITIATIVE LOOKED AT SAFER MEDICATION USE IN PREGNANCY AND HAS BEEN ACTIVELY UNDERTAKING SOME WORK AT THIS TIME. AND IT'S GOING TO BE LAUNCHING A NEW WEBSITE A CONVERSATION STARTER TOOL, A TOOL TO HELP FACILITATE A CONVERSATION BETWEEN A WOMAN AND HER PROVIDER, THE IDEA BEING THAT TO BRING INTO THE DISCUSSION EVEN IF YOU'RE CONTEMPLATING PREGNANCY OR NOT F YOU'RE IN A POSITION WHERE YOU COULD BECOME PREGNANT TO CONSIDER MEDICATION USE AND THE BEST OPTION IN THAT CONTEXT FOR THE PROVIDER AND THEN THE PATIENT. BUT I WAS TALKING TO DR. GREENAND SAYING IT IS ALL WELL AND GOOD FOR US TO SAY LET'S STARTED A CONVERSATION AND TALK TO YOUR PROVIDER, BUT THEN HOW DO WE ASK THE PROVIDERS IN WE ARE ASKING FOR PEOPLE TO WORK IN A CHANGING AND EVOLVING LANDSCAPE AND I THINK FROM MY CLINICAL PRACTICE AS A GENETICIST, SO I'M VERY PRIVILEGED THAT I HAVE ABOUT 45 MINUTES TO FOCUS ON THIS WITH A PATIENT AND A GENETIC COUNCILOR AND ALL THE DATABASES AND THEN I WONDER HOW COULD 3 OUT BETTER. SO I'M GOING TRY TO EDITORIALIZE IT'S NOT THE ANSWER, BUT SOME OF THE THINGS TO CONSIDER. ONE IS, AND I LIKED THE WAY YOU BROUGHT IT UP, JAMIE. YOU BASICALLY BOTTOM LINE, YOU WANT TO BREASTFEED, CAN I TAKE THIS MEDICATION? THAT'S THE QUESTION. AND UNFORTUNATE PART IS IN GENERAL THERE IS NOT REALLY A YES/NO ANSWER. NUMBER 1, NOT ALL OUTCOMES ARE THE SAME. THERE IS A FEW OF THEM BUT IT'S NOT USUALLY -- THEN THERE IS A NO ANSWER. BUT THAT IS SAY MUCH SMALLER PORTION OF THE LANDSCAPE. REALLY USUALLY WE ARE TALKING ABOUT SHORTER AND LONG-TERM OUTCOMES FOR THE MOM OR THE BABY. WE ARE SORT OF WEIGHING IT'S ALL ABOUT SHARED DECISION-MAKING, BASED ON RISK BENEFITS AND ALTERNATIVES AND IT'S RATHER COMPLICATED HOW YOU'RE GOING TO WEIGH SEVERE MENTAL ILLNESS WITH THIS PARTICULAR AGENT IS REALLY THE BEST WELL AGENT FOR THE MOM'S MENTAL HEALTH WITH INCREASED RISK OF -- OF THE NEWBORN WHICH CERTAINLY IS REAL BUT LIKE YOU HAVE TO START TO WEIGH THAT. WHAT ELSE HAS MOM TRIED? ARE THERE ALTERNATIVES? CAN SHE GET TO A SINGLE AGENT? WHERE IS THE BABY GOING TO BE BORN? DO WE HAVE AN ICU? IS IT A SAFE SETTING? THESE ARE COMPLICATED DISCUSSIONS. SO TO JUST ROLE THEM INTO ONE POT LIKE YES OR NO, LIKE IT'S A CHALLENGE TO THINK ABOUT HOW TO ENCAPSULATE AND SUMMARIZE THIS INFORMATION TO AGAIN SUPPORT THIS CONVERSATION BETWEEN A PATIENT AND A PROVIDER IN THE CONTEXT OF SHARED DECISION-MAKING. THE OTHER THING IS, A LOT OF TIMES PATIENTS WILL CONFUSE LIKE TERATOGEN OR CAN'T TAKE JUST THE SIDE EFFECT. LIKE EVERY MEDICATION HAS LOTS OF SIDE EFFECTS SO ONE CAN TAKE A MEDICATION AND BE AWARE OF THE SIDE EFFECT AND IT'S A SAFE SETTING. SO I THINK ONE ISSUE TO THINK ABOUT IS SAFER ALTERNATIVES. THAT'S PART OF THE DISCUSSION. IT'S NOT A YES/NO BUT IS THERE A SAFER ALTERNATIVE AND HAS THAT BEEN CONSIDERED AND CAN THAT BE MOVED TOWARDS -- SORT OF PART OF THE REALLY INFORMED PIECE THAT THE CLINICIAN CAN BRING TO THE TABLE? MY LAST COMMENT IS A LITTLE OFF TOPIC. I WONDER IF THERE IS SAY WAY TO THINK ABOUT HOW THIS TASK FORCE COULD SUPPORT RESEARCH IN THE FIELD. WHAT I SEE IS A LOT OF TIMES THE SAME MISTAKES MADE IN RESEARCH IN THIS FIELD AND IF THERE WAS A WAY WE COULD LIKE POINT OUT A ROADMAP THAT LIKE DO IT THIS WAY, NOT THAT WAY, SO LIKE AS EXAMPLES, STUDIES WILL LOOK AT LET'S SAY LIKE NICOTINE REPLACEMENT THERAPY. AND THEN THEY'LL USE THOSE AS CONTROL GROUP NOT SMOKING. LIKE THAT IS NOT GOING TO REALLY HELP ANYBODY BECAUSE IF YOU COULD GET TO NON SMOKING, YOU DON'TS NEED NICOTINE REPLACEMENT THERAPY. YOU HAVE TO DO A STUDY WHERE YOU USE SMOKING AS THE REFERENCE POINT. SO WE END UP WITH THIS DATA SAYING THAT NICOTINE REPLACEMENT THERAPIES PROVIDES INCREASED RISK BUT IT ISN'T REALLY DATA THAT SUPPORTS THE CLINICAL QUESTION. AND SO TO THAT EXTENT ISN'T HELPFUL DATA IN THE FIELD. AND ANOTHER ISSUE THAT COMES UP ALL THE TIME IN STUDIES IS, RESIDUAL CONFOUNDING AND IF IT'S NOT WELL CONTROLLED FOR. LIKE WHATEVER INDICATION IT WAS THAT THE MOTHER OR THE PARENT HAD TO TAKE THE MEDICATION, THAT EXISTS IN THE FAMILY HISTORY OF THAT NEWBORN AS THEY MOVE FORWARD AND THAT IS ALWAYS GOING TO INFLUENCE THEIR RISK. SO AGAIN TO REALLY DO A BETTER JOB OF HELPING STUDIES SET THEMSELVES UP PROPERLY TO AS BEST AS CAN BE EXPECTED, CONTROL FOR RESIDUAL CONFOUNDING AND TRY TO GET AT THE QUESTION OF THAT WAS MEDICATION OR THAT EXPOSURE ACTUALLY CAUSAL? BECAUSE THAT'S WHAT WE WANT TO GET TO. AND I THINK IN THE MOVEMENT FROM THE SAFETY AND EFFICACY OF THIS MEDICATION, THE IDEA THAT ONE STUDY WOULD DO IT IS PROBLEMATIC. LIKE WHEN YOU THINK OF CAUSATION IN ANYTHING IN MEDICINE IT'S USUALLY A SERIES OF STUDIES. IT'S A PROGRESSION OF RESEARCH. AND I FEEL LIKE WE NEED TO PROMOTE THAT WAY OF THINKING AROUND THIS TOPIC OF, MEDICATION AND PREGNANCY BECAUSE WE HAVE ANIMAL STUDIES AND WE'LL HAVE PK STUDIES. LIKE WE NEED THE RESEARCH TO MOVE FORWARD LIKE WE KNOW SOMETHING. AND THEN WE MAY ASK ANOTHER QUESTION AND THEN WE NEED TO MOVE THE FIELD FORWARD. SO I WONDER IF THIS TASK FORCE COULD HELP KIND OF LAY THAT ROADMAP OUT AS OPPOSED TO WHAT WE HAVE -- I ALWAYS FIND IT CONFUSING THAT ONE STUDY ON DATA WHERE THEY LOOK AT PRESCRIPTIONS AND THEN SAY IT'S A TERATOGEN. YOU DON'T EVEN KNOW IF THE MEDICATION WENT IN THE PERSON'S BODY BUT NOW IT'S HITTING THE PRESS IT'S A TERATOGEN. HOW CAN WE MOVE FROM THAT WHICH IS KIND OF A VERY REACTIVE STANCE AROUND THESE MEDICATIONS AND PREGNANCY TO SOMETHING WHERE WE SAY, THERE IS A SORT OF STATE OF KNOWLEDGE ABOUT THIS EXPOSURE OR THIS MEDICATION. AND WE ARE GOING TO TRY TO HELP MOVE THAT FORWARD SO WE GET AS A GROUP OF PROFESSIONAL PROVIDERS AND CLINICIANS TO SOME SENSE OF THE TRUTH OF THAT. AND I THINK THERE IS A ROADMAP AND I WONDER IF THIS GROUP COULD HELP TO KIND OF LAY THAT OUT? >> AMERICAN COLLEGE OF MID WIVES AND MIDWIFERY AND WOMEN'S HEALTH. THANK YOU VERY MUCH FOR INVITING ME. I REALLY ENJOYED THIS CONVERSATION. I FEEL LIKE MY BRAIN IS ON OVER DRIVE TRYING TO FIGURE OUT SOME SORT OF UNIFYING OR 3-4 UNIFY PRINCIPLES. VERY QUICKLY DR. GREEN, THE EIGHTH EDITION OF THE PERINATAL GUIDELINES IS PROBABLE NEYOUR MAIL RIGHT NOW ACTUALLY. AND I JUST CHECKED YOUR SLIDES AND THEY ARE BOTH THE SAME ALTHOUGH THE PERINATAL GUIDELINES ARE PROBABLY MORE. BUT PRECONCEPTION IS EXACTLY THE SAME. I THINK IN TERMS OF DEMNATION, ONE THING WE HAVE NOT BROUGHT UP, IT IS VERY IMPORTANT FOR THIS TASK FORCE AND FOR ITS RECOMMENDATIONS AND THAT IS HEALTH LITERACY AND HEALTH NUMEROUS. BECAUSE I'M LOOKING BOTH AT OUR TARGET AUDIENCE AS BEING OUR PATIENTS, WOMEN WHO ARE PREGNANT AND FAMILIES AS WELL AS CLINICIANS AND BELIEVE IT OR NOT, HEALTH LIT ADVICE CRITICAL IN BOTH DEPARTMENTS. THERE IS VERY LOW-HANGING FRUIT ON THAT FRONT. ABSOLUTE RISKS VERSUS RELATIVE RISKS FOR INSTANCE. THERE IS SAY LOT OF WAYS AND THE INSTITUTED OF NATIONAL ACADEMIES -- I FORG ET WHAT THEY ARE CALLING THEMSELVES THIS WEEK, HAD A REALLY INTERESTING WORKSHOP ON THIS LAST YEAR AND THEY HAVE GOT THEIR STUFF PUBLISHED ON THE ROUNDTABLE AND HEALTH LITERACY. I THINK THERE IS SAY GREAT DEAL OF LOW-HANGING FRUIT ON THAT FRONT THAT THIS TASK FORCE COULD RECOMMEND PRETTY QUICKLY AND EASILY IN TERMS OF OUR DISSEMINATION A LOT OF MATERIALS ARE NOT AT A LITERACY LEVEL THAT IS EASY FOR PEOPLE TO ACCESS. I THINK WE REALLY COULD THINK ABOUT WE NEED UP-TO-DATE FOR PATIENTS. EVERY PROVIDER GOES TO UP-TO-DATE. EVERY PROVIDER GOES APP. MY SON-IN-LAW AND HIS FAMILY PHYSICIAN IS DOWNLOADING APPS RIGHT AND LEFT AND USING THEM ALL THE TIME IN THE OFFICE. AND SO, THOSE KINDS F WE COULD MATCH THOSE SO THE PATIENT AND PROVIDER. IT WILL BE TWEAKED A LITTLE BIT OBVIOUSLY, YOUR UP TO DATE FOR PATIENTS. ONE OF THE TRICKS WITH DISSEMINATION IF YOU JUST COMPILEAISE CLEARING HOUSE OF RESOURCES SO YOU GOT THE CD R AND FDA AND TREATING FOR TWO AND OTIS. YOU WILL RUN INTO THE PROBLEM THEY ALL WILL SAY SOMETHING SLIGHTLY DIFFERENTLY. AND IT REALLY IS THEN GOING TO SLOW DOWN THE PROVIDER IN TRYING TO GATHER AND INTERPRET THAT DATA FOR THE OFFICE VISIT WHICH IS 10 MINUTES LONG. SO, I THINK THAT WE SHOULD LOOK AT SOME MODELS AND MAYBE TAKE FROM A COUPLE OF DIFFERENT MODELS MAYBE STARTING WITH THE CDC'S MODEL WHERE YOU HAVE THE PATIENT SIDE AND THE PROVIDER SIDE, LOOK AT SOME OF THE -ED - LIKE LACK MED HAS GREAT OUTLINES AND HEADINGS BUT THEY ARE NOT USER-FRIENDLY FOR CLINICIANS AND REALLY SORT OF RECOMMEND SOME BASIC OUTLYING STRUCTURE FRAMEWORK FOR THE MATERIAL THAT WE WOULDN'T WOULD WANT TO DISSEMINATE. I THINK THAT'S WHAT I HAVE TO SAY ON DISSEMINATION. I HAVE ONE QUICK POINT ON OUR EARLIER TALK ABOUT GETTING THIS RESEARCH AND COORDINATION AND COLLABORATION. ON THAT FRONT, I WOULD BE REALLY QUITE INTERESTED IN LEARNING A LITTLE BIT MORE ABOUT WHAT WE COULD -- I'M THE LOW-HANGING FRUIT MENTALITY HERE. IS THERE SOMETHING THAT COULD BE DONE IN THE PRE-CLINICAL STUDIES THAT WOULD BE AN EASY PIECE TO CARVE OFF? LIKE MORE PK STUDIES. WHEN YOU'RE DOING INTERVENTION STUDIES, IS THERE SOME PORTION OF THAT THAT COULD FILL IN SOME OF THE GAPS BECAUSE I THINK OUR POINT THE GAPS IN THE RESEARCH, NOT WHAT WE KNOW BUT WHAT WE DON'T KNOW. SO SOME OF THE BASIC PHARMACOKINETIC AND PHARMACODYNAMIC AND GENOMIC DATA ON SOME OF THIS STUFF. AND MYULANT POINT IS, IF WE NOW HAVE SOME REALLY INTERESTING TECHNOLOGY, FOR TESTING LIKE THE PLACENTA, SO YOU HAVE GOT THESE FACILITIERS AND YOU HAVE GOT A MACHINE AND YOU CAN RUN A BUNCH OF DRUGS AND STUFF THROUGH THAT AND FIGURE OUT A LOT OF THAT IS TRANSFORMATION. COULD WE DO THAT FOR BREASTFEEDING? WHY NOT? I MEAN, THERE ARE GRADUATE STUDENTS AND BIOPHYSICS AT U.C. BERKELEY THAT ARE DYING FOR A PH.D. THESIS SOMEWHERE AND THE TECHNOLOGY IS SITTING THERE. I'M JUST THINKING THAT A LOT OF WHAT IS OUT THERE, WE JUST SNEED TO LOOK AT HOW TO APPLY IT BECAUSE I THINK YOU CAN GET WOMEN INTO STUDIES A LOT MORE IF WE HAVE A LOT MORE SOLID DATA FROM THE PRE-CLINICAL WORK. I REALLY BELIEVE THAT THAT ELEPHANT IN THE ROOM IS STILL THE SAFE FOR MY BABY. AND IF WE CAN SOLVE SOME OF THAT WITH JUST A LOT OF THE COMPUTER SIMULATION AND A LOT OF THE HIGH-TECHNOLOGY THAT IS OUT THERE AND I THINK IT IS AVAILABLE FOR USE AND IS PROBABLY AGAIN LOW-HANGING FRUIT IN TERMS OF STUDIES COMPARED TO GETTING MILLIONS OF TRIALS IN NETWORKS. SO THANK YOU. >> DR. SPONG: THANK YOU VERY MUCH. I THINK THIS IS A GREAT INITIAL FORAY INTO THIS QUESTION OF RECOMMENDATIONS ON DISSEMINATION ON RESEARCH FINDINGS AND INFORMATION PREGEVANT TO PREGNANT AND LACTATING WOMEN TO PROVIDERS AND THE PUBLIC. SO WE HAVE GOT A CHARGE. WE DID TALK EARLIER TODAY ABOUT THE IDEAS OF PROVIDING A WEBSITE OR UPDATING A WEBSITE ON INFORMING WOMEN ABOUT CLINICAL TRIALS AND RESEARCHING PREGNANCY AND LACTATION. I THINK THAT IS ALSO IN HERE. I'D LIKE TO OPEN UP TO THE ROOM FOR ADDITIONAL THOUGHTS AND COMMENTS AND RECOMMENDATIONS. >> KRISTI, UCB. THIS IS THE TO THE COLLEAGUES IN THE AGENCIES. WHEN YOU DO COMMUNICATION PIECE THAT IS GO OUT ON THE WEB OR EDUCATION, DO YOU DO ANY MONITORING OR MARKETING REACH OF THOSE MATERIALS THAT GO OUT? WHO IS RECEIVING? HOW OFTEN? AND THEN ALSO ANY SEARCH ADVERTISING ON GOOGLE SO THEY RISE TO THE TOP AND YOU'RE NOT GETTING SOME OF THE NOT SO GOOD INFORMATION UPFRONT BESIDES HITS >> I'M PROBABLY NOT THE BEST SUITED PERSON BUT I DO KNOW THAT THEY EVALUATE THAT. WE DO GET REGULAR UPDATES AND COMMON HITS AND HOW MANY READS OF OUR WEB MATERIALS. SO I KNOW THIS ACTIVE MONITORING OF THAT. BUT I CAN REQUEST AND PROVIDE MORE INFORMATION ABOUT THAT IF YOU NEED TO. >> FROM AN INDUSTRY PERSPECTIVE WE MONTHAT ARE ALL THE TIME SO AS PART OF THE TASK FORCE MAYBE WE ADD THAT DATA IN THERE WHERE PEOPLE ARE SEEKING THE INFORMATION AND HOW CREDIBLE AND DO SOME RESEARCH ON THAT. ON SOME OF THE WORK WE DO AS WELL. >> SO, WHAT THE REACH WAS IN PARTICULAR AND HOW OR WHAT WAS FEATURED IN THE NEWS AND HOW FREQUENTLY. [ LOW AUDIO ] >> JENNIFER LYNNE. AND I JUST WANTED TO PIGGYBACK ON WHAT SHA VON SAID AND SOME OF THE INFORMATION AND THINGS WE LEARNED IN REVAMPING OUR WEBSITE SO THANK YOU FOR POINTING THAT OUT WE ARE WORKING ON IT. ONE OF THE THINGS WE FOUND FROM DOING SOME DIFFERENT AUDIENCE TESTING OF BOTH HEALTH CARE PROVIDERS AND PATIENTS IS THAT WOMEN DON'T LIKE -- BOTH AUDIENCES DON'T LIKE TO BEING PUT INTO BUCKETS. WE OFTEN DO THAT. WE SAY OKAY F YOU'RE A WOMAN CLICK ON THIS OR A CONSUMER. IF YOU'RE A PRESCRIBER OR HEALTH CARE PROFESSIONAL, CLICK ON THIS WEBSITE. IT SEEMS LIKE A LOT OF CROSS-POLLINATION AND LOOKING AT BOTH SIDES SO THAT IS SOMETHING TO KEEP IN MIND AS WELL. AND FOR WOMEN, IT MIGHT BE BECAUSE THEY FEEL LIKE THEY ARE MISSING OUT ON INFORMATION LIKE THE DOCTOR IS GETTING SOMETHING I'M NOT GETTING. AND SO THAT IS JUST SOMETHING TO KEEP IN MIND AND ONE, I THINK THAT SHOWS THE NEED FOR A MORE LAY-FRIENDLY INFORMATION THAT IS EVIDENCE-BASED BUT THAT IS PROVIDING THEM WITH THE AMOUNT OF DETAIL THEY NEED SO THAT THEY ARE NOT GOING AND TRYING TO PULL INFORMATION FROM THE OTHER AREA. BUT JUST KNOW WE ARE TRYING TO THINK OF THIS ONE-STOP-SHOP PLACE TO PUT ALL OUR INFORMATION AND MAKING SURE WE ARE PUTTING IT OUT AND DISSEMINATING IT IN A WAY THE PUBLIC IS GOING TO UTILIZEED. >> WE HAVE ALWAYS DEALT WITH THE PLLR. WE CHANGED THE WAY THE INFORMATION IS ARTICULATED AND THERE ARE SOME STANDARD PHYSIOLOGY NETHERE WHICH I THINK DOES IMPACT. LIKE FOR EXAMPLE ANIMAL DATA DOESN'T ALWAYS PREDICT OUT COMES WHICH IS TRUE BUT A DISCLAIMER STATEMENT THAT YOU CAN IGNORE THIS INFORMATION. THE KEY INFORMATION IS IN THERE AND OBVIOUSLY ALL THE EXPOSURE YOU WERE TALKING ABOUT BOTH IN NON PREGNANT VERSUS PREGNANT. AT THE RISK OF SAYING AND CONTRADICTING MYSELF, THERE IS ALWAYS AN EXTRAPOLATION FROM A NON-CLINICAL SPECIES INTO HUMAN. PARTICULARLY IN THE BIOLOGICS ARENA WHERE WE HAVE DONE A LOT OF WORK LOOKING IN NON-CLINICAL SPECIES BUT AS AN EXAMPLE BIOTHERAPEUTICS AND ANTIBODIES, ET CETERA, ALL USE SAME SCRN MECHANISM AND THAT IS SAY REALLY GOOD STORY TO BE ABLE TO UNDERSTAND THE DIFFERENCES BECAUSE AS WE DISCUSSED AT LENGTH DOING EXPOSURE TO STUD NIECE HOOPS IS CHALLENGING. BUT -- STUDIES IN HUMANS. WE HAVE PLACENTAL HUMANS FROM MOVEMENTS AND WE CAN COMPARE AND CONTRAST BETWEEN NON-CLINICAL SPECIES AND UNDERSTAND HOW MUCH IS EXPRESSED AND WHERE AND BECAUSE WE HAVE THE EXPOSURE DATA IN THE NON-CLINICAL SPECIES WE CAN THEN START TO UNDERSTAND WHERE ARE THE SIMILARITIES AND WHERE THERE ARE DIFFERENCES SO WE CAN MAKE A MUCH MORE INFORMED ASSESSMENT OF RISK FROM THERE. >> I THINK SUSAN YOU BROUGHT UP THIS MORNING THAT WOMEN TEND TO GOOGLE WHERE THEY GET THEIR INFORMATION. I'M A DOCTOR OF -- I DO RESEARCH ON PREGNANCY. BUT AS A PHYSICIAN WHEN I WAS PREGNANT, I DID THE SAME THING. SO, IT'S JUST EASIER TO DO IT THAT WAY AND I'M WONDERING AS EUROPE TALKING ABOUT HOW TO REINVENT THE WHEEL, HAVE WE THOUGHT ABOUT COLLABORATING WITH BABY CENTER OR THE PARENT'S MAGAZINE WHICH I FEEL LIKE ALL OF MY MOM FRIENDS READ. AND HAVE THEM KIND OF LINK TO THE CDC WEBSITE OR LINK TO THE FDA WEBSITE ON GUIDANCE ON MEDICATION SAFETY OR LEVERAGING SOMETHING NA IS ALREADY EXIST EXISTING. >> THANK YOU FOR THAT COMMENT. I COMPLETELY AGREE WITH YOU. I LOVE THE IDEA OF THE UP-TO-DATE MOMS. THAT'S ONE WAY OF NOT PUTTING NIM BUCKETS BUT TO A MORE SCIENTIFIC REVIEW OF THE LITERATURE WHEN YOU'RE TALKING ABOUT CLINICAL DECISIONS. AND THEN ON A MORE MOM-FRIENDLY KIND OF REVIEW THAT WOULDN'T BE SUBSCRIPTION-BASED. YES, I THINK IT WOULD BE -- CAN YOU HEAR ME? I THINK IT WOULD BE HELPFUL TO BE ABLE TO LINKED TO A NUMBER OF ORGANIZATIONS, THE AMERICAN COLLEGE OF NURSE MID WIVES, LAMAZE INTERNATIONAL, PARENTS MAGAZINE, BABY MAGAZINE, THAT COULD LINK BACK TO THE CDC WEBSITE. LIKE I SAID EARLIER, I DON'T THINK WOMEN NECESSARILY GRAPHITATE TO THE DOTTED GOVERNOR SITES UNLESS IT'S SOMETHING FOR ZIKA -- DOT GOV SITES UNLESS IT'S FOR SOMETHING LIKE ZIKA. BUT THAT IDEA OF A UP-TO-DATE FOR MOMS IS BRILLIANT. >> I KNOW UP-TO-DATE DOES HAVE A PATIENT EDUCATION PIECE. I FIND THAT THAT IS AGAIN HIGHER LITERACY SO THERE IS A LITTLE BIT OF AN ISSUE. THERE IS THE LANGUAGE ISSUE THERE. BUT IT ALSO DOESN'T GIVE THE INFORMATION T GIVES THE RECOMMENDATIONS. AND WHAT I WOULD LIKE TO SEE US DO IS GIVE THEM THE INFORMATION. >> KATY SHUBERT. AS WE ARE THINKING ABOUT THIS IDEA OF HOW PATIENTS ARE GETTING OR CONSUMERS -- I DON'T THINK LIGHT TO THINK OF PREGNANT WOMEN AS PATIENTS BUT IF THAT'S WHAT WE ARE GOING TO CALL IT, HOW THEY ARE GETTING THE INFORMATION BUT ALSO WE CAN PUT A WEBSITE TOGETHER AND I THINK THAT WOULD BE GREAT BUT ARE THEY GOING TO GO THERE? HOW IS IT BEING DISSEMINATED? AND GOING BACK TO THE IDEA OF YESTERDAY I ASKED A QUESTION ABOUT FDA DATE AT AND PREGNANCY LABELING AND LACTATION, I THINK HAVING A BENCHMARK FOR KNOWING WHAT ALREADY IS HAPPENING FROM THE PATIENT PERSPECTIVE AND WHERE THEY ARE GETTING THEIR INFORMATION ALONG THE LINES OF THOSE GOOGLE ANALYTICS TYPES OF THINGS OR SOME MECHANISM BY WHICH YOU CAN GET THE INFORMATION ABOUT THEMSELVES ABOUT WHERE THEY ARE GETTING INFORMATION. WE KNOW IT IS GOOGLE BUT NUMBERS WOULD BE HELPFUL AND UPTAKE WOULD BE HELPFUL SO THE TASK FORCE KNOWS WHERE YOU ALL NEED TO GO WITH THAT AND WHAT SUCCESS LOOKS LIKE. YOU WOULD HATE TO PUT TOGETHER A CLEARING HOUSE OR A LIST OF LINKS OR WHATEVER IF KNOWN IS GOING TO GO THERE AND USE IT. 1*GZ. >> I HAD A QUICK COMMENT KIND OF A QUESTION. YESTERDAY, WE MENTIONED PECOREY AS BEING A POTENTIAL PARTNER OR STAKEHOLDER FOR COMPARATIVE EFFECTIVENESS. ONE OF THEIR OTHER AREAS OF FOCUS IS DISSEMINATION AS WELL. SO, I DIDN'T KNOW IF PI COREY HAD BEEN ENGAGED IN THIS CONVERIVATION OR IF NOT, THEY THINK IS ANOTHER AVENUE. >> JAMIE, NATIONAL COALITION. I HAD BEEN REMISS TO PULT OUT HERE IN REGARDS TO ACCESSIBILITY AND DISSEMINATION WHEN WE TAKE A LOOK AT JUST THE ASSESSABILITY THROUGH THE PHONE, THIS IS SOCIOECONOMIC AVAILABILITY TOOL THAT SEEMS TO GO ACROSS ALL RACES AND ALL SOCIOECONOMIC BREAKDOWNS AND I THINK THAT THAT IS SOMETHING THAT JUST A TEXT FOR BABY, WE SEEN FOLKS ARE ABLE TO SIGN UP FOR THAT AND RECEIVE TEXT. JUST THINKING OF THINGS THAT I'M SURE WE'LL CONTINUE TO TALK ABOUT. DO YOU DO A FACEBOOK LIVE CHAT? A EXITER CHAT? DO YOU HAVE A SNAPCHAT? A LITTLE BLURB OUT THERE. DO YOU HAVE IT SO THAT THERE IS ALL THE MOMMY GROUPS THAT ARE ON FACEBOOK -- THERE ARE A TICKER TO THE RIGHT OF THAT AND THE WHATEVER WE ARE GOING TO END UP CALLING THIS OR WHATEVER THE INFORMATION GETS HOUSED COMES UP ON THAT AD BOARD AND TRYING TO THINK ABOUT HOW TO REACH RURAL TO FOLKS THAT ARE JUST CHECKING OUT THEIR PHONE BECAUSE I THINK THAT WE NEED MAKE SURE THAT WE ARE REACHING EVERY POPULATION ACROSS-THE-BOARD. AND I THINK THAT THIS IS THE BIGGEST TOOL WE'VE GOT. THANK YOU. >> THIS IS STEPHANIE ARCHER, NICHD, THE PREG SOURCE TEAM THAT HAS BEEN MENTIONED. >> PLEASE TELL US MORE ABOUT THAT. >> I DON'T KNOW IF WE HAVE TIME TO GO INTO THAT BUT ONE THING I WANTED TO BRING UP IS AS PART OF THIS, IT'S GOING TO BE ON A WEBSITE THAT ANYONE CAN ACCESS. WE PUT TOGETHER A REALLY GOOD RESOURCE LIBRARY FROM ALL THE PARTNERS, INCLUDING SMFM AND A COG, MARCH OF DIMES AND WE ARE LINKING TO A LOT OF THEIR EXISTING INFORMATION FOR PATIENTS THAT WOMEN CAN COME IN AND SEARCH FOR DIFFERENT CATEGORIES OF INFORMATION THERE. SO THAT IS ONE PLACE THAT WOMEN COULD GO TO. THEY DON'T HAVE TO JOIN THE STUDY IN ORDER TO SEE THE RESOURCE LIBRARY. >> I'M ALL ABOUT COMMUNICATION. SM FM, ACOG HAS VERY GOOD PATIENT PAMPHLETS FOR EVERY GUIDELINE THEY HAVE. RCOG DOES THAT AND EVEN THE COCHRAN REVIEW HAS PATIENT WEBSITE THAT THEY EXPLAIN THE PROBLEM AND WHAT THEY FOUND. BUT THE ISSUE IS, HOW USEFUL IS IT WITHOUT ANY DATA? PATIENTS WANT TO KNOW DO I DO THIS OR I SHOULD NOT DO IT. AND MOST OF THE TIME THE CONCLUSION IS, WE REALLY DON'T KNOW. TALK TO YOUR DOCTOR. SO TO ME, IT'S ALL BOILING DOWN TO DATA. TO STUDIES THAT WILL INFORM WHATEVER WE WANT TO PUT OUT FOR PATIENTS. I LOVE YOUR IDEA. IF A PATIENT IS ON -- WE CAN DO THAT. WITHOUT FUNDING WE CANNOT DO IT. PHARMACOKINETIC STUDIES DEPENDING ON THE MEDICATION, OUR FRIENDS FROM THE OPRU CAN TELL US T TAKES 8-12 HOURS TO DO FARM QUO KINETIC STUDY. SOMEBODY HAS TO BE WITH A PATIENT. THEY HAVE TO HAVE I R AND A WAY TO DO -- YOU HAVE TO THEN DO MASS SPEC TO MEASURE THE CONCENTRATION. ALL OF THAT TAKES EFFORT, MONEY AND SUPPORT. SO WE CAN TALK ABOUT INFORMATION BUT WITHOUT THE DATA, IT'S GOING TO BE THE SAME AS WE HAVE BEEN DOING SO FAR, TALK TO YOUR DOCTOR. >> I AGREE WITH WHAT WAS SAID AND IN MY EARLIER COMMENTS I TALKED ABOUT BUILDING RESEARCH INFRASTRUCTURE. SO I COULDN'T AGREE WITH THAT MORE. BUT JUST ON DISSEMINATING WHAT WE HAVE TODAY, A COUPLE OF THINGS ONE, AT MARCH OF DIMES, WE HAVE A THING WHERE PEOPLE CAN E-MAIL US QUESTIONS. IT'S CALLED, ASK US. AND WHEN WE MONITOR THAT CLOSELY, THAT WAS WHERE THE WHOLE SMOKING POT FOR NAUSEA AND VOMITING PREGNANCY GOT A LOT OF TRACTIONS. WE ARE LIKE WE BETTER LOOK AT. THIS WE'LL RESEARCH IT AND SEND OUT A BLURB ON OUR BLOG, NEWS MOMS NEED, AND THEN WE TRY TO MAKE VIDEOS AND TRY TO MAKE SHORT 1-2 MINUTE VIDEOS IN ENGLISH AND SPANISH. WE POST THEM ON OUR SITE AND PUT THEM ON YouTube BECAUSE WE FEEL LIKE AGAIN WITH THE GENERATION THAT FOLKS NOWADAYS WHO ARE PREGNANT MAY BE MORE PRONE TO WATCH A YouTube VIDEO AS OPPOSED TO READING A LENGTHY PAMPHLET OR READING A LONG SITE. SO THESE ARE NOT EITHER-OR PROPOSITIONS. THESE ARE CATCH PEOPLE WHERE YOU CAN. PEOPLE WHO EITHER DON'T READ BECAUSE THEY DON'T HAVE THE LANGUAGE SKILLS OR THEIR LITERACY SKILLS OR AREN'T INCLINED TO READ BECAUSE THEY ARE MORE INCLINED TO WATCH A VOLVEMENT SO THOSE ARE SOME OF THE TOOLS THAT WE HAVE USED TO DISSEMINATE MORE BROADLY. I THINK THE LANGUAGE ISSUES ARE REALLY IMPORTANT. WE HAVE SO MANY PATIENTS WHO DON'T SPEAK ENGLISH N MY PATIENT POPULATION, IN THE BRONX WHERE I WORK, WE TRY TO MOVE TOWARDS CASE STUDIES, VIGNETTES, STORIES, OUR UNDERSTANDING HOW TO COMMUNICATE WHAT WE ARE SAYING. WE ARE COMMUNICATING UNCERTAINTY BECAUSE IF WE HAD GOOD DATA, WE WOULD BE MUCH MORE WELL POSITIONED TO GIVE A CLEAR RECOMMENDATION. WE START TO BE OR HAVE A LONGER DISCUSSION OF WEIGHING RISKS AND BENEFITS. BOUQUETS STUDIES COULD HELP. THIS WOMAN WAS THINKING OF GETTING PREGNANT. SHE WAS ABLE TO MOVE FORWARD FEELING BETTER. JUST TO BOIL DOWN THE BASIC PRINCIPLES. BUT THAT VIGNETTE CASE STUDY STORY APPROACH ESPECIALLY FOR NON-ENGLISH SPEAKING FOLKS CAN BE QUITE USEFUL. >> JUST A QUICK COMMENT. WITH MY SOCIETY WITH INTERNAL MEDICINE. THERE WAS RENAISSANCE INITIALLY TO DO SEVERAL YEARS AGO TO PARTNER WITH SOME OF THE PLACES LIKE BABY CENTER AND SUCH AS WE WEREN'T SURE WHO IS TRACKING THE DATA AND HOW CLEAN IS IT GOING TO BE AND ALL THIS? BUT I CAN TELL YOU, WE NOW ARE WORKING WITH THEM. WE ARE WATCHING AND TRACK HOW MANY PEOPLE REVIEW THE DATA OF WHAT DATA IS OUT THERE. SO WE TRACK IT VERY CAREFULLY. WE SEE WHAT THEY WRITE AND HAVE A VERY GOOD RELATIONSHIP WITH THEM. WE ARE STARTING TO BUILD RELATIONSHIPS LIKE THAT AND FROM A COMMUNICATION STANDPOINT AS WE KEEP SAYING, AS LONG AS SOMEBODY IS THERE TRACKING THE ACCURACY OF THE INFORMATION, I THINK IT'S THE WAY WE HAVE TO MOVE AND FROM THIS STANDPOINT, WE AGREE WITH THAT AND IT SOUNDS LIKE A LOT OF THE ORGANIZATIONS ARE AGREEING. AS LONG AS YOU'RE DOING THAT, IT'S A SUPERB WAY OF GOING ABOUT IT. >> WE HAVE OR CAN COUNT CLICKS, GOOGLE AD CAMPAIGNS. THERE IS THIS THING THAT SOME OF THE AGENCIES AROUND THE TABLE RECOGNIZE THE PAPERWORK REDUCTION ACT, WHICH IS A BARRIER TO SENDING OUT SURVEYS TO WOMEN. SO WE ARE NOT EASILY ABLE TO DO NATIONAL SURVEYS. AND THEN A LOT OF PEOPLE CREATE REALLY GREAT PATIENT EDUCATION MATERIALS BUT HOW IS THAT CHANGING BEHAVIOR? SO MY QUESTION IS, HOW ARE PREGNANT WOMEN UTILIZING THE INFORMATION WE GIVE THEM TO REALLY MAKE DECISIONS? AND DO WE HAVE THAT BODY OF EVIDENCE AND THAT BODY OF KNOWLEDGE? >> I CAN ADDRESS THAT VERY BRIEFLY. WE DEFINITELY HAVE THE SAID PATIENT EDUCATION PIECE EVERY MONTH AT A LOWER LITERACY AND IN SPANISH AS MUCH AS POSSIBLE. AND I THINK THE BODY OF KNOWLEDGE IN HEALTH LITERACY HAS GOTTEN THE BODY OF SCIENCE HAS GOTTEN QUITE SOPHISTICATED AND DEFINITELY IF YOU'RE HANDED A PIECE OF PAPER BY THE NURSE AS EXIT, IT DOESN'T MAKE THE SAME IMPACT AS IF YOU WERE HANDED THAT PIECE OF PAPER BY YOUR CLINICIAN. SO THERE ARE A LOT OF THINGS WE KNOW ABOUT THAT. AND A LOT WE DON'T KNOW, OBVIOUSLY. BUT I THINK THAT THERE IS SOME GOOD, LOW-HANGING FRUIT, ON ALGORITHMS, PICTURES, SHORT SENTENCES, THINGS THAT ARE PRETTY SIMPLE AND EASY TO DO. RISKS VERSUS RELATIVE RISKS THAT ARE VERY HELPFUL AND CAN BE VERY EASY TO APPLY AND DEFINITELY IMPROVE COMPREHENSION ON BOTH FRONTS, PROVIDER AND PATIENT. >> JENNIFER FROM SCRIPPS. I WANTED TO COMMENTS THAT WITH OUR WEBMD PREGNANCY APP, WE JUST LAUNCHED AND WE REALLY WANT TO SHOW WOMEN HOW THEIR DATA COMPARES TO OTHERS WHO HAVE SIMILAR CHARACTERISTICS WITH THEM IN TERMS OF WEIGHT GAIN OR EVEN MEDICATIONS AND SYMPTOMS THEY MAY BE EXPERIENCING. WITH THIS PARTNERSHIP WITH WEBMD WE CAN DISSEMINATE TO A WIDER RANGE OF PEOPLE. >> SO, KAREN, WE HAVE A LOT OF DATA ON VEHICLE SEEN HESITANCE. A LOT OF WHAT YOU'RE TALKING ABOUT RIGHT NOW. I DON'T THINK YOU'RE THERE YET. I JUST WANT TO CLARIFY THAT I THINK GOOD INFORMATION IS STILL GETTING THAT INFORMATION TO PATIENTS STILL GOOD. BUT WHAT FDA SAID IS TRUE. WE HAVE STUDIES THAT SHOW WHEN YOU TELL INFORMATION TO A PATIENT, THEY ARE LESS LIKELY TO GET VACCINATED. SO IT'S BETTER NOT TO TELL THEM ANYTHING SOMETIMES. SO WE HAVE TO KEEP THAT IN MIND. IT'S NOT ONLY ABOUT GIVING INFORMATION, IT'S A LOT OF BEHAVIORAL SCIENCE AND HOW TO GIVE INFORMATION AND HOW TO CONVINCE THEM TO DO SOMETHING THEY DON'T WANT TO DO. THE OTHER THING S JUST ANSWERING A QUESTION, YES, WE HAVE VACCINE.GOV IN ENGLISH AND IN SPANISH. AND WE ALSO TRACK SOME MARKET DATA POINTS. AND WE ALSO HAVE THOSE THAT TRY TO GET THE VERY FIRST HIT YOU GET ON TO. >> I JUST WANTED TO PROVIDE A BIT OF AN INDUSTRY PERSPECTIVE, AND IT'S NOT TO CHANGE THE DIRECTION OF THE CONVERSATION BUT IT WILL A BIT IN TERMS OF INDUSTRY COMMUNICATION AND DISSEMINATION, WHICH AGAIN IS VERY HIGHLY REGULATED. SO, WHEN WE ARE THINKING ABOUT THE TASK FORCE AND INCLUSION AND INDUSTRY IN MEDICATION INFORMATION, THERE MADE IN FACT BE RESTRICTIONS ON HOW WE CAN CONTRIBUTE TO THAT INFORMATION BECAUSE WE GO THROUGH VERY FORMAL PROCESS OF HOW THE INFORMATION ISN'T ONLY PUT INTO A LABEL FOR USE BASED ON THE AVAILABLE EVIDENCE BUT ALSO HOW THAT INFORMATION IS THEN PUT INTO USEABLE INFORMATION WITHIN PATIENT INFORMATION LETTERS AND HOW WE CAN THEN COMMUNICATE THAT TO PRESCRIBERS, AS SOMETHING TO THINK ABOUT MOVING FORWARD FOR THE TASK FORCES. WE CAN PARTICIPATE AND THE COMMUNICATION AND INFORMATION DISSEMINATION. >> SORRY. AS A PEDIATRICIAN I WANTED TO JUST REITERATING WHOLE VACCINE, ANTI-VACCINE AS WE REALLY LEARNED A LOT FROM OUR ANTI-VACCINERS AND WE NEED SOMEONE WHOSE NOT A PHYSICIAN TALKING ABOUT IT. WE NEED AN ACTRESS WHO HAS BROAD APPEAL. WHO HAS NOTHING TO DO WITH THE SCIENCE AND WHO SAYS OH, MY GOD, IT'S GREAT. AND WE DON'T HAVE OR I DON'T SEE ANYONE TALKING ABOUT A PUBLIC FACE PERSON TO TALK TO PREGNANT WOMEN THAT SAYS, I'M PREGNANT AND I DID THIS FOR MY BABY AND IT WAS GREAT. WE ONLY SEE ACTRESSES SHOWING THEIR BOOTY, SORRY. OR OTHER STUFF. BUT WE ACTUALLY DON'T HAVE WHAT THE ANTI-VACCINERS WHO HAVE DONE A REALLY FANTASTIC JOB ON THEIR PR. AND WE ARE STRUGGLING WITH THAT ON THE PEDIATRICIAN SIDE, ON THE VACCINE SIDE TO GET CUTE LOOKING ACTORS AND ACTRESSES TALKING ABOUT SAVING THEIR BABIES, BUT THE SAME APPLIES TO THE OB WORLD. YOU NEED SOME CUTE AND SEXY ACTORS AND ACTRESSES TALKING ANY THEIR PREGNANCIES AND DOING THE RIGHT THING. >> SO, I WOULD LIKE TO JUST TAKE OFF MY SCIENTIST CAP FOR A SECOND AND SPEAK AS A FORMER PREGNANT WOMAN AND LACTATEING MOM. HOW MUCH OF THE TIME IS SPENT TRYING TO COLLECT DATA FROM THE PATIENT SINCE WE ARE CALLING PREGNANT WOMEN'S PATIENTS? BECAUSE FOR SO OFTEN THE PHYSICIANS AND SCIENTISTS ARE TRYING TO DUMP INFORMATION ON TO THE PATIENTS AND YOU'RE SAYING THAT THEY DON'T WANT TO LISTEN, OR FOLLOW. THE TRUTH OF THE MATTER S THE EVIDENCE ISN'T THERE. WE REALLY AREN'T SURE. IS THERE ANIEST TROUGH TRY TO COLLECT INFORMATION FROM THE PATIENT THEMSELVES TO UNDERSTAND HOW IT IS THAT THEY ARE ACTUALLY FEELING AND MAYBE THEY CAN HELP PROMPT DIFFERENT DIRECTIONS FOR STUDYING THE AREA BETTER. >> I AGREE WITH YOU 100% AND I THINK -- I WAS TRYING TO SAY EARLIER, WE REALLY NEED TO MAKE THIS WOMAN FOCUS. WE CAN'T HAVE THIS ALL ABOUT DISEASES OF PREGNANT WOMEN. WE NEED TO FIND OUT WHAT THEY WANT TO KNOW, HOW THEY WANT TO LEARN IT. SO, ANYWAY, AGREED. >> ANY OTHER QUESTIONS, COMMENTS, THOUGHTS, ADDITIONAL DISCUSSION? IF NOT, WE WILL PULL UP WHAT I HEARD TO MAKE SURE THAT WHAT I HEARD IS WHAT YOU WANTED TO HEAR AND WANTED TO TELL ME. WE'RE GOING TO REVIEW WHAT THIS PANEL DISCUSSING WAS NUMBER 3, DISSEMINATION OF RESEARCH FINDINGS AND INFORMATION RELEVANT TO PREGNANT WOMEN AND LACTATING WOMEN TO PROVIDERS AND THE PUBLIC. DR. GREENMUST THINK I DID A GOOD ENOUGH JOB. SO HERE WE GO. DISSEMINATION OF RESEARCH FINDINGS. SO VERY QUICKLY. LOTS OF DIFFERENT WAYS THAT WE GIVE INFORMATION TO PEOPLE. ALL KINDS OF DIFFERENT WAYS BECAUSE WE ARE REACHING ALL KINDS OF DIFFERENT PEOPLE AND IMPORTANTLY THIS IS BOTH PROVIDERS AND THE PUBLIC FOR THE PUBLIC PROVIDERS DO PROVIDE MUCH OF THE INFORMATION. AND CURRENTLY LOTS OF PEOPLE GET INFORMATION FROM THEIR PHONE AND THAT INFORMATION FROM THE INTERNET COMES FROM A VARIETY OF SOURCES. LOTS OF OPPORTUNITIES. ONE OPPORTUNITY IS TO PROVIDE ACCESS TO EVIDENCE-BASED TREATMENT INFORMATION, SCALABLE PROGRAMS, PROVIDE TRAINER AND SUPPORT THEM TO PROVIDE EVIDENCE-BASED CARE AND ON LINE DATABASE WITH FEDERAL INFORMATION ON MEDICATION SAFETY: [ READING ] THOSE LAST TWO ARE KIND OF SIMILAR. SO THAT'S THE BEST I COULD. CHALLENGES. LOTS OF CHALLENGES. PROVIDERS HAVE LIMITED INFORMATION. THAT'S PRETTY WELL HIGHLIGHTED AND THEY HAVE LIMITED TIME TO PROVIDE THIS INFORMATION IT'S HARD TO COMMUNICATE UNCERTAINTY AND THIS IS WHAT WE DO EVERY DAY BECAUSE WE HAVE LIMITED INFORMATION. IT CIRCLES BACK AND FORTH. AND THE QUESTION IS, ONCE WE GIVE THAT INFORMATION, HOW DO PEOPLE USE THAT INFORMATION? DOES BEHAVIOR CHANGE? COMMUNICATING THIS INFORMATION IS NOT EASY. IT'S NOT A YES/NO. IT'S IN THE CONTEXT OF FOR THAT PATIENT OF RISK AND BENEFIT. WE NEED TO PROMOTE THE THINKING OF RESEARCH THAT IS A PROGRESSION. NO SINGLE STUDY THAT IS GOING TO FIX EVERYTHING. IT'S IMPORTANT FOR US TO HAVE STUDIES THAT ADDRESS THE QUESTION THAT WE NEED ANSWERED. AGAIN, A CHALLENGE IS LOTS OF PEOPLE GET INFORMATION FROM THE INTERNET. WE NEED BENCHMARKS OF WHERE PEOPLE ARE GETTING THEIR INFORMATION. IF PEOPLE DON'T USE WHATEVER WE MAKE, IT'S NOT GOING TO BE THAT HELPFUL BECAUSE THERE IS LOTS OF OPTIONS OUT THERE. ANOTHER CHALLENGE IS THERE ARE GENERATIONAL DIFFERENCES IN HOW PEOPLE TAKE INFORMATION AND WANT INFORMATION. SO ONE-SIZE-FITS-ALL ISN'T GOING TO WORK ON HOW WE DISSEMINATE THIS INFORMATION EITHER. HARD TO MAKE AN EVIDENCE BASE WHEN WE DON'T HAVE A LOT OF EVIDENCE. VERY IMPORTANT WHETHER WE DO PROVIDE AND DISSEMINATE THIS INFORMATION THAT IT IS IN A FORM THAT PEOPLE CAN UNDERSTAND. THE HEALTH LITERACY COMPONENT. DIFFICULT AND LOTS OF TIMES THESE INTERNET SEARCHES SAY SOMETHING A LITTLE BIT DIFFERENT. THAT THEN THE PROVIDERS ASKED TO HELP THE PATIENT UNDERSTAND WHAT THOSE DIFFERENCES MEAN. SO ADDING MORE BURDEN TO THE PROVIDERS. AND THEN INDUSTRY, AS A HELPER OF DISSEMINATING THIS INFORMATION IS ALSO HAS ADDITIONAL REGULATIONS AND RESTRICTIONS THAT THEY ARE UNDER. SO, JUST MORE CHALLENGES FOR US. ANYTHING I MISSED? I THINK WE SHOULD FEEL PRETTY GOOD ABOUT OURSELVES. WE HAVE GONE THROUGH 1, 2, 3 AND 4 ON THIS AND I REALLY FEEL THAT WE HAVE SOME PRETTY ROBUST INFORMATION FOR ALL OF THESE AREAS AND I'M LOOKING FORWARD TO WORKING WITH YOU ALL AS WE PUT THAT TOGETHER. WHAT I THINK WE'LL DO NOW IS TAKE A SHORT BREAK AND THEN COME BACK AND WE HAVE THE LAST PANEL THAT IS GOING TO SUM UP WHAT ARE ALL THOSE RECOMMENDATIONS SO WE CAN THEN START ON THE JOURNEY OF PUTTING TOGETHER ONE COMPONENT OF THE REPORT. WE ARE A LITTLE BIT AHEAD OF SCHEDULE, WHICH I THINK IS A BLESSING. IT'S ALWAYS GOOD TO BE AHEAD. YOU GET BETTER RATINGS THAT WAY. SO WE WILL COME BACK AT 2:00. (BREAK) >> DR. SPONG: WELCOME BACK, EVERYONE. DELIGHTED WITH ALL THE ACTIVE DISCUSSION AND CAMARADERIE WE HAVE IN THE ROOM ABOUT THIS TOPIC, WHICH IS CLEARLY VERY, VERY IMPORTANT, DID THE PASSION IS PALPABLE. I'D LIKE TO SPEND THE NEXT AMOUNT OF TIME FOR US TO REALLY SORT THROUGH THE INFORMATION THAT WE HAVE PULLED TOGETHER OVER THE LAST DAY AND A HALF. WE ARE GOING TO BEGIN WITH REACTION TO THE POTENTIAL RECOMMENDATIONS FROM THE PANEL AND THEN WE WILL OPEN IT UP FOR DISCUSSION AND I PICKED THIS PANEL SPECIFICALLY BECAUSE I KNEW THEY WERE UP TO THE CHARGE OF NOT HAVING A LOT OF GOOD INFORMATION WALKING INTO THE MEETING TO KNOW WHAT TO PREPARE FOR. BUT INSTEAD, FOR THEM TO JUST KIND OF THINK THROUGH IT AND GIVE US GOOD RECOMMENDATIONS TO START THE DISCUSSION. AND THAT'S REALLY WHAT I WAS HOPING THE PANEL WOULD DO IS JUMPSTART THE DISCUSSION OF WHAT RECOMMENDATIONS CAN THE TASK FORCE COME UP WITH. AGAIN, I PUT UP ON THE SCREEN THE CHARGE FOR TODAY. THESE ARE THE TOPICS WE COVERED TODAY. THE IDENTIFICATION OF FEDERAL ACTIVITIES THAT MEET THE STATE OF THE RESEARCH, THE RECOMMENDATIONS FOR CURED NATION AND COLLABORATION AND THE DISSEMINATION OF THE RESEARCH FINDINGS AND THEN THE EXISTING FEDERAL EFFORTS AND PROGRAMS. UNDERSTANDING THAT THE SIGN LANGUAGE BROAD AND I THINK WE REALLY CAME TO A NICE DECISION YESTERDAY ON THE SCOPE SO WE WILL BE ABLE TO INCORPORATE EVERYTHING IN OUR REPORT AS WE MOVE FORWARD. SO I'M GOING TO GO AHEAD AND START. SPEAKING FIRST WILL BRIGITTE JONES AND DIANE SPATS AND DR. ROBERT TERNICK AND LINDA LIPS ON. >> THANK YOU. BRIGITTE JONES, JONES MERCY. SO FIRST, I'D LIKE TO THANK YOU% FOR INVITING ME. THIS HAS BEEN REALLY GREAT AND ENLIGHTENING CONVERSATION FOR ME. SO FIRST JUST STARTING WITH THE STATE OF THE RESEARCH IN PREGNANCY. I THINK YESTERDAY WE SAW SOME REALLY, REALLY STRIKING STATISTICS AND I THINK LIKE THE DATA THAT ANN SHOWED, THE ONE SLIDE STILL STICKS OUT IN MY MIND THAT COMPARED PREGNANCY WITH PATIENTS WITH ALS TO SHOW HOW LITTLE DATA WE HAVE IN PREGNANT WOMEN COMPARED TO VERY RARE DISEASES. SO I THINK THINKING ABOUT TAKING PREGNANCY AS A CASE STUDY, POSSIBLY, TO DESCRIBE HOW LITTLE DATA WE HAVE OR INFORMATION WE HAVE ABOUT HOW TO TAKE CARE OF WOMEN WHO ARE PREGNANT AND ARE LACTATING MIGHT BE ONE POTENTIAL WAY TO SHOW THOSE GAPS REALLY WELL. I WANT TO THANK THE WOMEN -- I'M SORRY -- I FORGOT YOUR NAME. YES. KATE. WHO SHARED HER STORY TODAY. IT WAS REALLY -- I'LL NEVER FORGET THAT STORY BECAUSE I THINK IT'S A STORY THAT COULD HAPPEN TO ANY OF US. YOU END UP HAVING A CONDITION WHILE YOU'RE PREGNANT AND YOU GO TO A HOSPITAL AND IT'S A REALLY GOOD HOSPITAL, AND THE DOCTORS THERE JUST DON'T KNOW WHAT TO DO WITH YOU. AND I THINK WALKING THROUGH A CASE OF WHAT WOULD ACTUALLY HAPPEN IN A WOMAN THAT IS PREGNANT THAT HAS TO USE A MEDICATION FOR A CERTAIN CONDITION OR DISEASE, AND THINKING ABOUT WHAT DO WE KNOW ABOUT WOMEN'S HEALTH IN GENERAL AND DON'T KNOW. WHAT DO WE KNOW ABOUT PREGNANCY AND SOME OF THE CONDITIONS THAT ARE OCCURRING IN PREGNANCY LIKE THINGS LIKE PREECLAMPSIA. SO IF YOU PUT THAT ON TOP OF IT, AND THE WOMAN HAS TB OR ANOTHER DISEASE AND YOU HAVE TO TREAT THEM, WHAT ARE THE THINGS THAT YOU NEED TO THINK ABOUT? SO WOULD CLINICIANS KNOW HOW TO PUT THAT TOGETHER? WHO WOULD THEY CALL? WHO WOULD BE THE EXPERTS TO HELP THEM AND GUIDE THEM WITH A CLINICAL PHARMACOLOGIST REALLY BE ABLE TO HELP YOU THAT MUCH? BECAUSE THERE IS NOT VERY MUCH DATA OUT THERE FOR THEM TO USE. SO I THINK PUTTING IT IN THE PERSPECTIVE OF WALKING THROUGH A CASE MIGHT BE REALLY HELPFUL IN ILLUSTRATING WHAT THE SIGNIFICANT NEEDS ARE AND THE IMPACT. AND THEN FOR THE SECOND QUESTION, THE INFRASTRUCTURE OR THE COLLABORATION. I THINK IT'S IMPORTANT TO DEVELOP A INFRASTRUCTURE OR PIPELINE FOR SHARING INFORMATION, FOR SHARING TECHNIQUES AND HOW TO CONDUCT THESE STUDIES ACROSS THE DIFFERENT AREAS OF THE GOVERNMENT, THE DIFFERENT AGENCIES. DEVELOP A PIPELINE OF COMMUNICATION SO THAT THOSE IDEAS CAN BE SHARED REALLY WELL IN A STANDARD WAY BECAUSE LIKE I MENTIONED EARLIER TODAY, THERE IS SOME GREAT THINGS THAT ARE GOING ON ALL ACROSS THE DIFFERENT AGENCIES AND A LOT OF GREAT DATA, BUT IT SEEMS LIKE NO ONE REALLY KNOWS WHAT EVERYONE ELSE IS DOING AND THAT IS NOT REALLY EASILY SHAREABLE. SO I THINK FOCUSING ON TRYING TO SHARE THAT INFORMATION AND THAT DATA IS IMPORTANT. ALSO ESPECIALLY IMPORTANT IN CONDUCTING SOME OF THE WORK THAT NEEDS TO BE DONE, BUT I THINK THERE IS SAY NEED TO BUILD UPON EXISTING NETWORKS THAT ARE ALREADY SUCCESSFUL IN DOING WHAT THEY DO. AND THEY HAVE GOT SOME OF IT DOWN TO A SCIENCE OF HOW TO DO THIS REALLY WELL AND EFFICIENTLY. SO BUILDING UPON THOSE NETWORKS AND THOSE INFRASTRUCTURES AND LEARNING FROM THEM HOW TO CONDUCT THE STUDIES AND COLLABORATING AROUND HOW TO CONDUCT TRIALS IN WOMEN. I THINK THERE IS SOME NOVEL THINGS THAT CAN BE CONSIDERED WHEN CONDUCTING TRIALS IN WOMEN THAT ARE PREGNANT BECAUSE WE HAVE TALKED ABOUT THE BARRIERS THAT IS REALLY TOO HARD DO TO CONDUCT TRIALS IN WOMEN, ETHICS OF IT, BUT I THINK THERE IS SOME NOVEL THINGS THAT CAN BE CONSIDERED LIKE OPPORTUNISTIC SAMPLING TECHNIQUES WHERE THE WOMAN IS ON MEDICATION -- BECAUSE THEY ARE USING MEDICATIONS REGARDLESS OF WHETHER WE HAVE THE DATA. SO IF THEY COME INTO A CLINIC, CAN WE GET A BLOOD SAMPLE ON THEM TO STUDY THEIR PK? USE SAMPLING DESIGNS WHERE YOU DON'T HAVE TO HAVE A WOMAN COME INTO A STUDY UNIT AND STAY FOR 12 OR 24 HOURS. BECAUSE THAT'S NOT GOING TO BE FEASIBLE FOR THEM. SO USE POPULATION PK TECHNIQUES TO BE ABLE TO GET SPARSE SAMPLING AMONG ALL DIFFERENT TYPES OF WOMEN AT DIFFERENT TIME POINTS TO INFORM ORB PROVIDE YOU WITH DATA. ALSO THINKING ABOUT THINGS LIKE MODELING AND SIMULATION THAT IS STARTING TO BE USED MORE IN PEDIATRICS, OR OTHER NOVEL TYPES OF DESIGNS. SO LEARN FROM WHAT HAS ALREADY BEEN DONE IN OTHER AREAS THAT CAN HELP INFORM US OF THE MOST EFFICIENT AND SAFE WAY TO DO THESE STUDIES IN CHILDREN. AND THEN OR IN WOMEN. AND THEN, FOR LIKE I MENTIONED EARLIER, I THINK THE DATA COLLABORATION IS REALLY, REALLY KEY. SOME TYPE OF DATA WAREHOUSE WHERE WE CAN COMBINE ALL OF THIS REALLY GOOD DATA THAT WE ALREADY HAVE AND POSSIBLY MAKE IT PUBLICLY ACCESSIBLE AS WELL TO OBTAIN BASELINE INFORMATION AND TO GENERATE SAFETY SIGNALS TO BUILD OFF OF TO INFORM OUR FUTURE STUDIES. AND THEN, I THINK THERE HAS TO BE SOME TYPE OF INCENTIVE FOR ALL OF THESE GROUPS TO COME TOGETHER, ESPECIALLY WE WANT TO ENGAGE INDUSTRY AND ENGAGE A LOT OF DIFFERENT PEOPLE THAT HAVE THEIR PRIORITIES AT THE END ARE ALL THE SAME BUT I THINK THAT WE HAVE TO HAVE SOME TYPE OF INCENTIVE TO BRING EVERYONE TOGETHER AND GET EVERYONE ON THE SAME PAGE. AS FAR AS DISSEMINATION PIECE, I REALLY THINK THAT WE HEARD THAT THE CURRENT METHODS OF HOW WE SHARE INFORMATION WITH OUR PATIENTS ARE BECOMING OUTDATED AND ALREADY OUTDATED. IT MAY NOT BE FEASIBLE TOED THAT ON TOP OF THE LONG LIST OF TOPICS THAT AN OBSTETRICIAN HAS TO ADDRESS OR PEDIATRICIAN HAS TO ADDRESS WITH THE NEW MONAL AND WE HEAR PEOPLE GET THEIR INFORMATION FROM THE INTERNET NOW SO, I THINK THIS IS A REALLY GREAT OPPORTUNITY TO START MOVING THE WAY THAT WE COMMUNICATE WITH OUR PATIENTS AND TO -- INTO THE 21ST CENTURY AS AN SPECIALIST, I FEEL BAD BECAUSE I GIVE THEM A FOOD ALLERGY PLAN AND AN ASTHMA ACTION PLAN AND GIVE THEM ALLERGIC PLAN AND THEY LEAVE MY CLINIC WITH FOUR PIECES OF PAPER AND I KNOW THEY DON'T LOOK AT THEM. SO I USUALLY POINT THEM TO WEBSITES THAT SAY, WHEN YOU GET HOME, I KNOW YOU'RE NOT GOING TO REMEMBER THIS, SO IS GO TO THIS WEBSITE. THIS IS SAY GOOD WEBSITE FOR YOU TO GO TO. SO I THINK THAT FOCUSING ON MORE ON LINE INFORMATION IS THE WAY TO GO. I WENT TO THE -- WHEN YOU TOLD US TO GOOGLE THE WEED AND SOMETHING -- I WENT TO -- SO WHEN I GOOGLED THAT THE FIRST THING THAT CAME UP WAS BABY CENTER. AND SO THEN I WAS LIKE WHO OWNS BABY CENTER? AND WANTED TO LEARN A LITTLE BIT MORE ABOUT IT BECAUSE IT'S THE FIRST 3-4 THINGS THAT COME UP. AND SO THEY TALK ABOUT IT REACHES MORE THAN 45 MILLION PARENTS A MONTH. FROM EVERY CORNER OF THE GLOBE THROUGH 11 OWNED AND OPERATED PROPERTIES. AND IT FUNCTIONS IN NINE DIFFERENT LANGUAGES, 8 IN 10 NEW AND EXPECTED MOMS ON LINE USE BABY CENTER EACH MONTH. SO A HUGE REACH. SO I THINK WE HAVE TO COLLABORATE WITH ON LINE SITES LIKE THIS TO GET INFORMATION OUT TO WOMEN. I THINK IT'S OVER BURDENSOME FOR HEALTH CARE PRACTITIONERS AND IT'S NOT A EFFICIENT WAY OF COMMUNICATING THE INFORMATION. I THINK HEALTH LITERACY HAS TO BE CONSIDERED WHEN MAKING SURE WE ARE COMMUNICATING INFORMATION EFFECTIVELY AND ALSO MULTILINGUAL COMMUNICATION AS WELL AS MAKING SURE OUR MESSAGES ARE DISSEMINATED WIDELY TO COMMUNITIES THAT ARE OFTEN LEFT OUT SUCH AS RURAL COMMUNITIES, MINORITY COMMUNITIES, DIFFERENT SOCIOECONOMIC GROUPS. SO MAKING SURE THAT THERE IS A WIDE NET CAST FOR HOW THE INFORMATION IS DISSEMINATED. AND ALSO HOW THE STUDIES ARE DONE AS WELL. ENGAGEMENT OF, YOU HAVE THE PREGNANCY WOMEN THAT ARE PREGNANT AND LACTATING AS UNDER REPRESENTED GROUP IN CLINICAL RESEARCH BUT IN THEM THERE ARE OTHER UNDER REPRESENTED GROUPS LIKE RACIAL MINORITIES AND PEOPLE THAT LIVE IN RURAL AREAS THAT ALSO NEED TO BE CRASHED IN THE RESEARCH PIECE OF IT. >> THANK YOU VERY MUCH. >> DIANE SACKS. I'M A PH.D. NURSE FROM THE UNIVERSITY OF PENNSYLVANIA SCHOOL OF NURSING AND THE CHILDREN'S HOSPITAL OF PHILADELPHIA. I'M NOT GOING TO REPEAT OF THE POINTS THAT BRIGITTE MADE. I THINK WE'LL HAVE SIMILAR REFLECTIONS AND I'M GOING TO BOLLED SOME OF THEM. SO, IF WE TAKE THIS STATISTICS OF OVER 4 MILLION PREGNANT WOMEN A YEAR OVER 81% OF WOMEN IN THE UNITED STATES ARE BREASTFEEDING. SO WE ARE TALKING ABOUT OVER 3 MILLION WOMEN. OVER 51% ARE STILL BREASTFEEDING IN SIX MONTHS SO WE ARE TALKING ABOUT OVER TWO MILLION WOMEN AND 30% OF STILL BREASTFEEDING A YEAR. THOSE ARE PRETTY HIGH RATES. THAT'S 1.2 MILLION WOMEN. OVER 90% OF WOMEN ARE PRESCRIED MEDICATIONS POST DELIVERY. WE KNOW THIS. WE KNOW THAT MEDICATION USES A MAJOR REASON THAT WOMEN STOP BREASTFEEDING. AND SO, I WAS TALKING TO MY COLLEAGUE, ROBERT, HE SAID MAYBE WE NEED TO CHANGE THE NAME OF THE TASK FORCE FROM PREG LACK TO LACK LEG AND MAKE AN EMPHASIS ON LACTATION. BECAUSE OVER ARCHINGLY THROUGHOUT THE PAST TWO DAYS, WE HAVE CERTAINLY HEARD MORE ABOUT PREGNANCY THAN LACTATION. AND SO, MAYBE IT WAS PREG LACK BECAUSE PREGNANCY COMES BEFORE LACTATION, HOWEVER YOU COULD NOT BE PREGNANT AND INDUCE LACTATION. SO, THERE ARE WOMEN WHO ARE NON-PREGNANT WHO DO INDUCE LACTATION WHO ARE FOR ADOPTED BABIES. AND SO, EMPHASIS ON NOT FORGETTING THE LACTATION PART OF THIS TASK FORCE IS WHAT I'M GOING PUT FORWARD. WHEN WE TALK ABOUT DISSEMINATION, WE HEARD SEVERAL TIMES YESTERDAY AND TODAY ABOUT PUBLICLY AVAILABLE DATA AND WEBSITES. SO IF YOU LOOK AT LACK MED, WHICH IS PUBLICLY AVAILABLE, THERE IS SOME GOOD INFORMATION ABOUT DRUGS AND LACTATION. BUT IF YOU GO TO, FOR EXAMPLE, MEDICATION MOTHER'S MILK. THE TOM HAIL BOOK WHICH HE HAS NOW MOVE ON BUT HE IS STILL WORKING. ONE BIG DIFFERENCE BETWEEN WHAT YOU FIND IN LACK MED AND MINGS MILK IS IN LACK MED THERE IS NO RELATIVE INFANT DOSAGE REPORTED OF THE MEDICATION. THAT IF YOU ARE ON MEDICATIONS AND MOTHER'S MILK WHICH YOU HAVE TO PAY FOR, IT'S NOT PUBLICLY AVAILABLE. THEY PROVIDE A RELATIVE INFANT DOSE. œTHE TRANSFER OF MEDICATIONS INTO MILK, IN GENERAL, IT'S LESS THAN 1%. ALTHOUGH THERE IS GREAT VARIABILITY. SO WHEN WE TALK ABOUT HOW PEOPLE ARE GETTING INFORMATION, WOMEN AREN'T GETTING THAT TYPE OF INFORMATION AND THEIR FAMILIES AREN'T GETTING THAT TYPE OF INFORMATION UNLESS THEY GO TO A CENTERED THAT IS PROVIDING REALLY EXCEPTIONAL EVIDENCE-BASED LACTATION SUPPORT AND CARE. AND WHAT WE TELL OUR FAMILIES AT CHILDREN'S HOSPITAL PHILADELPHIA, DON'T LOOK AT ANY OTHER WEBSITE OTHER THAN OURS AND THE LINKS WE HAVE OUR OR WEBSITE. BECAUSE THEY ALL GO TO THEIR PHONES AND GOOGLE AND THEY GET GET -- KELLY MOM. MAY OR MAY NOT BE EVIDENCE-BASED RIGHT? THE THE OTHER THING WE HEARD FROM THE PHARMACEUTICAL INDUSTRY IS THERE IS NO RESEARCH REALLY IN LACTATION AND MEDICATION. THERE IS NONE. VERY FEW TRIALS. IF YOU USE THE FIGURE THAT IS REPORTED IN RESEARCH, SOMEWHERE BETWEEN 10-20% WILL SAY -- WE'LL SAY MAYBE 15% OF WOMEN MAY HAVE TRUE ISSUES WITH MILK SUPPLY. TRUE ISSUES. THEY HAVE DONE EVERYTHING THEY ARE SUPPOSED TO DO. THEY STILL CAN'T MAKE MILK OR ENOUGH MILK. THAT'S ABOUT 500,000 WOMEN ANNUALLY. NOT A SMALL NUMBER. A CASE, YOU SAID LET'S WALK SOMEONE THROUGH A CASE. I HAVE A MOTHER RIGHT NOW, 41 YEARS OLD, PREGNANT THROUGH REPRODUCTIVE TECHNOLOGY. HAS A BABY WITH AGENTED ENTHRALL SEE WITH ITS ORGANS OUTSIDE OF ITS BODY. HUMAN MILK IS THE DIFFERENT BETWEEN LIFE AND DEATH FOR A BABY LIKE THIS. RESEARCH SHOWS IT. THIS MOM IS DOING EVERYTHING WE TOLD HER. SHE IS MAKING 100 MILLSFUL MILK A DAY. IF YOU DON'T KNOW ABOUT BREASTFEEDING, THAT'S NOT A NORMAL MILK SUPPLY. SHE HAS NO OPTION PRESENTSLY IN THE UNITED STATES TO GET ANY KIND OF PHARMACOLOGICAL AGENT TO INCREASE HER MILK SUPPLY. SHE IS LUCKY ENOUGH TO BE AT A HOSPITAL THAT HAS DONOR MILK AS A BRIDGE. THAT'S LESS THAN 50% OF HOSPITALS IN THE UNITED STATES. YES, YOU CAN NOT BE RESPITE AND TURN OUT OKAY BUT WHEN YOU'RE TALKING ABOUT SICK BABIES, HUMAN MILL SEMINOLE COUNTY A LIFE-SAVING MEDICAL INTERVENTION THAT HAS BEEN PROVEN TIME AND TIME AGAIN IN RESEARCH. THE LAST THING I'D LIKE PEOPLE TO CONSIDER AS WE THINK ABOUT THE WORK OF THIS TASK FORCE IS SOME PEOPLE IN THIS TASK FORCE ARE PEOPLE WHO PRESENTED AND HAVE USED THE WORD, PROVIDERS. BUT OTHERS HAVE VERY MUCH HAVE A PHYSICIAN FOCUS AND I HEARD A LOT OF PHYSICIAN LANGUAGE. I AM A NURSE. THERE ARE OVER 3 MILLION NURSES IN THE UNITED STATES. THEY ARE THE MOST TRUSTED HEALTH PROFESSION IN ALL POLLS. WHAT IS THE ROLE OF THE NURSE IN DISSEMINATING KNOWLEDGE? IN GETTING WOMEN ACCESS TO EVIDENCE-BASED LACTATION MEDICATION INFORMATION, PREGNANCY MEDICATION INFORMATION? NURSES ARE GENERALLY AVAILABLE 24-HOURS A DAY 7 DAYS A WEEK. THEY'RE IN THE HOSPITAL AND IN THE COMMUNITY. I THINK WE HAVE TO THINK ABOUT THAT ROLE. I'M CURRENTLY DOING A RESEARCH PROJECT WITH SOME COLLEAGUES AT THE UNIVERSITY OF SOUTH FLORIDA WHERE WE ARE USING A NURSE AND A CURE COUNSELOR TO TEACH MOTHERS PRENATALLY ABOUT MEDICATION USE AND THESE ARE ALL HIGH-RISK, LOW-INCOME PREDOMINANTLY AFRICAN-AMERICAN WOMEN WHO HAD DIABETES, HYPERTENSION, MULTI-HEALTH ISSUES. AND WE WERE ABLE TO EFFECTIVELY INCREASE THEIR BREASTFEEDING RATES WITH EDUCATION. AND YES, WE HAVE LIMITED DATA ON SOME MEDICATIONS AND LIMITED RESEARCH. RENEED MORE RESEARCH. WHEN YOU THINK ABOUT THE FACT THAT TRULY MOST MEDICATIONS CROSS THROUGH AT A VERY SMALL AMOUNT, ARE WE GETTING OR ENSURING THAT WOMEN ARE GETTING THE RIGHT INFORMATION? I THINK THAT'S ALL THAT DOESN'T REPEAT. LACK PREG. >> ARE WE GOING TO PATENT THAT? >> IT WAS YOUR IDEA. YOU CAN GET THE TRADEMARK. >> I THINK SO WHY I SHARED THAT WITH DIANE WAS, A REFLECTION OF THE PASSION FOR THE TOPIC AND CERTAINLY THE ENTHUSIASM AND THE PASSION FROM EVERYONE IN THE ROOM AND SO, I WOULD LIKE TO SAY THANK YOU FOR ALLOWING ME TO PARTICIPATE IN THIS. I THINK THROUGH MY EXPERIENCE IN WORKING WITH SIMILAR GROUPS, I THINK THE ENTHUSIASM AND PASSION AT THE END -- THAT THE INDIVIDUALS BRING TO THE TABLE IS PROBABLY THE BEST PREDICTOR OF SUCCESS FOR THE TASK FORCE AND SO I THINK YOU'RE OFF TO A REALLY GOOD START. I'LL TRY NOT TO BE REDUNDANT BUT, I WILL BE. BUT, DOCTOR JENKINS MENTIONED OR MADE A COMMENT YESTERDAY THAT WORDS I USE FREQUENTLY AND I HAD WRITTEN IT DOWN MYSELF AND THAT IS, WHAT DOES SUCCESS LOOK LIKE FOR THIS? TASK FORCE. THAT'S A QUESTION AS WE GO BACK TO OUR DAY JOBS FOR A LITTLE WHILE THAT EVERYONE REALLY NEEDS TO THINK ABOUT BECAUSE I THINK THERE IS A LOT OF POWER IN GOING THROUGH THAT MEANTAL EXERCISE. THE OTHER KEYWORD I WOULD SAY IS, ACTIONABLE. HOW DOES THE TASK FORCE CREATE A DOCUMENT THAT PUTS INTO THE HANDS OF OUR DECISION-MAKERS ITEMS THAT ARE ACTIONABLE TO MAKE DECISIONS WITH AND THAT WE CAN THEN GO OUT AS A UNIFIED COALITION FOR LACK OF A BETTER WORD, OF ACADEMICS AND OF REGULATORS, OF FEDERAL AGENCIES AND INDUSTRY TO MAKE PROGRESS IN A VERY RAPID TIMEFRAME ON THIS TOPIC. WE TALKED ABOUT LOW HANGING FOOT AND I THINK MAYBE THAT IS SOMETHING THAT AS WE CONSTRUCT THE REPORT F WE CAN IDENTIFY THAT LOW-HANGING FRUIT, LET'S BE VERY SPECIFIC ABOUT THAT AND TRY TO TRANSLATE THAT WITH ACTIONABLE ITEMS. SO, WHEN I LOOK AT THIS, I THINK REFLECTING OVER THE TWO DAYS I THINK ABOUT, HOW DO WE ELIMINATE THE PHRASE THAT WE HEARD SO MANY TIMES? TALK TO YOUR DOCTOR. YET THE PHYSICIAN OR HEALTH CARE PRACTITIONER IS LIKE YES, I'M NOT REALLY SURE WHAT TO TELL YOU. AND SO YOU JUST GET INTO THIS LOOP. SO, IF SUCCESS LOOKS LIKE HOW DO WE ELIMINATE SOME OF THAT, TALK TO YOUR DOCTOR, OR CERTAINLY FROM THE POSITION PHYSICIAN OR NURSE STAND POINTED, CAREGIVER STANDPOINT, MAKING SURE THAT THEY ARE EQUIPPED WITH THE RIGHT INFORMATION T STARTS WITH THE PREGNANT AND LACTATING WOMAN AND THEIR NEEDS, REALLY UNDERSTANDING AND IDENTIFYING THEIR NEEDS. AND THE NEEDS OF THEIR HEALTH CARE PRACTITIONERS. I HEARD A LOT OF FOUNDATIONAL INFORMATION IS AROUND PHYSIOLOGICAL AND BIOLOGICAL CHANGES THAT OCCUR DURING PREGNANCY AND LACTATION I THINK THAT'S A GREAT PLACE FOR US TO START. IF WE CAN ASSEMBLE THAT INFORMATION AND ANALYZE THAT INFORMATION, I'M LOOKING THAT THE FROM A VERY INDUSTRICENTRIC PERSPECTIVE WHETHER I MAKE THIS TIME AND SHARE THAT INFORMATION WITH THE SCIENTISTS THAT ARE RESPONSIBLE FOR THE DEVELOPMENT OF A NEW THERAPIES THAT ARE COMING, THAT WOULD BE AN EXTREMELY POWERFUL FIRST STEP. IT'S NOT THAT INDUSTRY DOESN'T HAVE EXMERRITIES IN THIS AREA BUT WE CERTAINLY DON'T HAVE -- EXPERTISE -- AS THE COMBINED KNOWLEDGE OF THE EXPERTS REPRESENTED BY THE INDIVIDUALS IN THIS ROOM TODAY. SO I THINK THAT IS SOMETHING THAT WE SHOULD REALLY BE FOCUSING ON. THAT CAN HELP US IN NEW STUDIES, WHAT PRE-CLINICAL WORK CAN BE EXECUTEED AND OUTSIDE OF DEVELOPMENT OF NEW DRUGS, HOW CAN WE DO BETTER RISK ASSESSMENTS AROUND THE DRUGS THAT ARE EXISTING IN THE FIELD TODAY THAT ARE BEING USED ROUTINELY? SO STARTING WITH THE PATIENT AND THEIR NEEDS THAT UNMET MEDICAL NEED, DISEASE STATE. NOT DISEASE STATE IN THE CONTEXT OF PREGNANCY IS A DISEASE STATE. IT'S NOT. PREGNANCY IS A NATURAL HUMAN CONDITION. BUT WHEN WE TALK ABOUT THIS, CAN WE BREAK IT DOWN? WHAT ARE THOSE PRE-EXISTING CONDITIONS THAT ARE COMMON? WHAT ARE CONDITIONS THAT RESULT AS A CONDITION OF PREGNANCY. AND START TO BREAK THIS CONVERSATION DOWN INTO BITESIZED PIECES THAT BECOMES A LITTLE BIT MORE DIGESTIBLE BECAUSE IT'S A VERY BROAD TOPIC. YESTERDAY WE TALKED ABOUT UNMET MEDICAL NEED AND WE TALKED ABOUT FREQUENCY AND TALKED ABOUT CRITICALITY AS MAYBE TWO BUCKETS. SO IF IT'S SOMETHING THAT IS OCCURRING A LOT, WELL, I THINK THAT ELEVATES THE NEED F IT'S SOMETHING THAT IS VERY SEVERE LIKE LIFE-THREATENING TO THE MOTHER, TO THE FETUS, I THINK THAT IS SOMETHING THAT ALSO GETS LUMPED INTO THAT UNMET MEDICAL NEED. AND THE DATA SHARING THERE IS IN THE WEST CLINICAL PRACTICE DATA. SO IN THE FIRST TOPIC, I GUESS, IT WAS A LITTLE BIT MORE ABOUT THAT BASIC PHYSIOLOGICAL BIOLOGICAL DATA AROUND THE PATIENT OR THE FEMALE AND CONDITION. THIS IS A LITTLE BIT MORE ABOUT WHAT ARE THOSE BEST INTERVENTION S. THE THIRD PIECE FOR ME IS THE CONVERSATION AROUND THERAPIES. WE TALKED ABOUT PRESCRIPTION DRUGS AND TALKED ABOUT OTCs AND TALKED ABOUT NUTRITIONAL SUPPLEMENTS AND VACCINES AND WE TALKED ABOUT HERBAL. ALL OF THAT NEEDS TO BE TAKEN INTO CONSIDERATION BUT I THINK WE CAN TAKE A TIERED APPROACH IN HOW WE DISCUSS THAT IN THE REPORT. THERE ARE AREAS IN THERE WHERE WE ARE MORE ADVANCED IN OUR UNDERSTANDING TODAY BASED ON OUR PAST PRACTICES THAT I THINK CAN PROVIDE A PATHWAY FOR WHERE WE IDENTIFY GAPS IN THOSE OTHER AREAS WHERE WE MIGHT NOT BE AS ADVANCED FOR TODAY. FOR EXAMPLE F WE ARE TALKING ABOUT NEW THERAPIES BEING DEVELOPED BY THE PHARMACEUTICAL INDUSTRY, A GOOD CONVERSATION AROUND WHAT WOULD THE ULTIMATE EXEMPLARY CASE STUDY LOOK LIKE AS A PRACTICING PHYSICIAN? AS A HEALTH CARE PROVIDER DEALING WITH PREGNANT AND LACTATING WOMEN, WHAT WOULD YOU WANT TO SEE COME WITH THAT PRODUCT IN THE LABEL AT THE TIME OF THAT PRODUCT WAS APPROVED BY THE REGULATORY AGENCY? IF WE CAN BEGIN TO BREAK THAT DOWN AND UNDERSTAND WHAT THAT LOOKS LIKE, WE CAN DRIVE THAT ENDGAME GOAL BACK INTO THE VERY EARLY STAGES OF DEVELOPMENT SO WE CAN BEGIN TO ASK THOSE QUESTIONS AND DESIGN OUR DRUGS OR AT LEAST DEVELOP OUR DRUGS IN A WAY WE COLLECT THAT INFORMATION AS WE GO ALONG. I THINK REAL WORLD EVIDENCE ALSO PLAYS A BIG ROLE FROM THIS CONVERSATION AND HOW CAN WE LEVERAGE THE YOU INCREASING ATTENTION PLAYING OR BEING PAID NOW TO COLLECTING REAL-WORLD EVIDENCE BOTH IN OUR CLINICAL TRIALS AND ALSO IN OUR POST MARKETING SURVEILLANCE. I THINK THAT WITH EXISTING THERAPIES, IT'S REALLY DATA GATHERING AND ANALYSIS EXERCISE, RIGHT? WHAT DO WE HAVE TODAY AND HOW IS THAT INFORMATION BEING ORGANIZED? AND THIS TIES THEN INTO OUR COMMUNICATION CONVERSATION. WHAT ARE THE INSTANCE WHAT IS THE FORMAT? AND I WOULD SUGGEST THAT MAYBE THE MOST IMPORTANT THING IN THE IMMEDIATE INSTANCE IS THAT COMMUNICATION STRATEGY AND IT NEEDS TO BE A EXTREMELY WELL THOUGHT THROUGH COMMUNICATION STRATEGY THAT THIS TASK FORCE RECOMMENDS BE PUT TOGETHER. I DON'T KNOW THE TASK FORCE CREATES THAT STRATEGY. THAT'S TO BE DETERMINED. BUT CERTAINLY THAT NEEDS TO BE AN OUTCOME FROM THIS WORK AND ENCOMPASSES ALL THE ELEMENTS THAT DR. GREENHAD ON HIS FINAL SLIDE. THE THINGS THAT DR. CURTIS TALKED ABOUT AS WELL. AND THEN OBVIOUSLY ADDING IN THAT HEALTH LITERACY IS REALLY UNDERSTANDING THAT TARGET AUDIENCE AND MAKING SURE THAT THAT IS BEING DELIVERED AGAINST. I TALKED ABOUT CONSISTENCY BETWEEN THE COMMUNICATION MECHANISMS VENUES. WE DON'T WANT DR. SHOPPING OR OPINION SHOPPING IF IT'S NOT CONSISTENT INFORMATION IT LEADS TO CONFUSION AND THAT RESULTS IN UNDESIRED OUTCOMES. FINALLY, INDUSTRY IS A WILLING PARTNER. I THINK THE MOST EFFECTIVE WAY TO INTERACT WITH INDUSTRY IS THROUGH WHAT CHRISTINA TALKED ABOUT THROUGH OUR TRADE ASSOCIATIONS IF YOU CAN GET TO US IN THE PRECOMPETITIVE SPACE, YOU ELIMINATE THE BARRIERS THAT ARE LEGAL AND OTHER BUSINESS CONSIDERATIONS I DON'T KNOW WE NEED TO CREATE A SEPARATE WORKING GROUP. MAYBE THERE ARE ONES WE CAN APPROACH AS A COALITION TO SAY HOW ABOUT ABOUT THIS AS EMERGING TOPIC TO TAKE ADVANTAGE OF THE EXISTING INFRASTRUCTURE FOR PRECOMPETITIVE COLLABORATION. SO THOSE TRADE GROUPS CAN BE A EFFECTIVE MECHANISM. I THINK WE NEED TO UNDERSTAND THE VALUE PROPOSITION. ABOUT INCENTIVES. I THINK INCENTIVES IS A DOUBLE EDGED SWORD. I THINK WE HAVE TO BE VERY THOUGHTFUL WITH REGARD TO THE APPROACH THAT WE WANT TO TAKE THERE. I WOULDN'T RULE ANYTHING OUT AT THIS STAGE OF THE GAME. BUT THERE ARE SOME DIFFERENCES BETWEEN WHAT WE ARE TALKING ABOUT HERE AND SOME OF THE LEGISLATION THAT HAS BEEN PUT IN PLACE WITH REGARD TO PEDIATRICS. I THINK WE CAN LEARNED FROM THAT AS A POTENTIAL WAY FORWARD. THE LAST COUPLE OF POINTS WOULD BE TEASERS. CAN WE FIND AN EXAMPLE OF WHAT WHAT A COMPREHENSIVE STRATEGY FOR NEW DRUG DEVELOPMENT WOULD LIKE LIKE? CAN WE EITHER FIND AN EXAMPLE WHERE WE ALL AGREE, YES, THAT IS WHAT GOOD LOOKS SUPPLYING CAN WE USE THAT? OR CAN WE CREATE THAT THE BESIDES WHAT WE BELIEVE TODAY THAT MIGHT CREATE AN ASPIRATIONAL GOAL TO ALLOW US TO ASK THE QUESTION, OKAY, IF THAT'S WHERE WE WANT TO BE, HOW ARE WE GOING TO GET THERE? AND THEN THE LAST PIECE AROUND THE ACTIONABLE SPEC IF WE CAN IDENTIFY OUR PROPOSED SPECIFIC STUDIES BASED ON WHAT WE KNOW TODAY, THAT SHOULD BE FUNDED OR EXECUTED, I THINK THAT IS ANOTHER POTENTIAL ACTIONABLE STEP WE PUT TOGETHER. SO THANK YOU FOR GIVING ME THE TIME. I HOPE THIS IS HELPFUL AND I LOOK FORWARD TO CONTINUING TO WORK WITH THE GROUP GOING FORWARD. >> SO THANK YOU ALSO. THIS HAS BEEN A WONDERFUL EXPERIENCE WITH LOTS OF DIVERSE AND INTERESTING INPUT FROM EVERYONE. I AGREE WITH THE CASE STUDY APPROACH. I ALSO THINK THE IDEA OF UNMET NEED AND KIND OF FOCUSING IN CRITICAL AREAS AND BUT WE DON'T KNOW ANYTHING -- AS LIMITED AS IT S WE DON'T EVEN KNOW THE QUALITY OF IT. SO I DO THINK THAT WE DO A LOT OF EVIDENCE IN THE VA AND THAT WE NEED TO DO A SYSTEMATIC REVIEW SO WE CAN REALLY SEE WHAT WE KNOW WE MAY HAVE INFORMATION BUT IT MAY NOT BE VERY GOOD. I'M SURE A LOT OF PEOPLE ARE FAMILIAR WITH THAT. IN TERMS OF COORDINATION AND COLLABORATION, WE HEARD ABOUT A LOT OF DIFFERENT PROGRAMS BUT I KNOW OUTSIDE OF THE NIH LOOP BUT I THINK IT WOULD BE HELPFUL TO GET MORE INFORMATION ABOUT THE SURVEYS NETWORKS AND PROGRAMS AND REGISTRIES IS HOW MANY RESEARCHERS AND WHAT DATA ARE AVAILABLE WOULD BE GOOD TO KNOW. I DON'T KNOW IF FDA HAS PATIENT-REPORTED OUTCOMES IF THAT IS PART OF THE REGISTRIES BUT I KNOW THAT THERE ARE CERTAINLY THAT IS KIND OF A RELATIVELY NEWER AREA WHERE THERE MIGHT BE DATA AS WELL AND I THINK IT WOULD BE IMPORTANT TO ASSESS THE DISTRICTS QUALITY AND POTENTIAL USEFULNESS OF THE INFORMATION THAT IS AVAILABLE FROM THOSE DIFFERENT SOURCES. SOMEONE MENTIONED EARLIER ABOUT SOME STANDARDIZED TERMINOLOGY BUT I THINK WE AT LEAST NEED TO KIND OF LOOK AT WHAT THE TERMINOLOGY IS AND SO, WE CAN DECIDE AND GET LACK OF CLARITY ABOUT THAT AS WELL. WITH REGARD TO FEDERAL COLLABORATION I THINK IT IS SILOED AND WE NEED TO FIND SOME WAY TO BETTER ADDRESS THAT AND I DON'T KNOW WHETHER THAT WOULD BE TO A SMALLER GROUP THAT MIGHT SHARE WHAT THEY ARE DOING AND HOW THEY CAN COLLABORATE COMING UP WITH A PILOT TEST CASE ABOUT HOW THESE DIFFERENT GROUPS COULD COLLABORATORS AND THAT LEADS ME TO MY POINT ABOUT DATA-MINING. SO I THINK WE SAID WE DON'T HAVE GOOD PRE-CLINICAL EVIDENCE OR CLINICAL TRIALS. WHAT ELSE COULD WE DO TO GET DATA IN A MORE TIMELY WAY? I COME FROM AN ORGANIZATION THAT HAS FREE DATA. WE DON'T HAVE A LARGE POPULATION OF PREGNANT WOMEN ALTHOUGH WE HAVE SOME. BUT IT SEEMS THAT THERE MIGHT BE SOURCES -- IF WE TRIED TO FIND OUT WHAT DATA ARE AVAILABLE, WHETHER THROUGH DOD, VA, AND CDC, FDA, TO TRY TO COME UP WITH WHAT WE HAVE. IT MAY NOT TELL US THE ANSWERS WE NEED FOR PATIENTS BUT IT COULD INFORM US ABOUT WHAT OTHER RESEARCH WE NEED DO DO, WHERE WE NEED TO GO IN POLICY AND PROGRAMS. SO WE DO HAVE INFORMATION AND THEN THE OTHER PART OF IT IS, OKAY, FOR A GROUP LIKE THE VA, WE COULD COLLECT DATA ON OUR PATIENTS AND OTHER FACTORS. WHAT SHOULD THAT LOOK LIKE? SO IT WOULD BE IDENTIFYING AS WE GO FORWARD WHAT KIND OF INFORMATION WOULD BE HELPFUL FROM MOTHERS, WOMEN AND PATIENTED THAT HELP US FILL IN SOME OF THESE GAPS WE HAVE RIGHT NOW. I THINK IT WAS RAISED IN TERMS OF DISPARITIES BECAUSE WE ARE TALKING ABOUT ALL WOMEN BUT THERE ARE A LOT OF DIFFERENT WOMEN WITH CULTURE GEOGRAPHIC LOCATION AND I THINK WE NEED TO BE COGNIZANT OF THAT AND THINK ABOUT THAT AND I THINK SOMEONE ELSE ALSO MENTIONED EARLIER, MARMINIZING MATRIX. BECAUSE I THINK WE NEED TO FIGURE OUT HOW TO PRESENT SOME OF THIS INFORMATION IN THE SUPREME COURT MAYBE THAT WOULD HELP INFORM HOW TO DISSEMINATE IT: I THINK IT WAS IMPORTANT WHEN IT WAS RAISED ABOUT PRECONCEPTION CARE, WE CAN'T JUST FOCUS ON WHEN WOMEN BECOME PREGNANT. THAT THAT COULD BE KIND OF TOO LATE IN THE GAME OR SHOULDN'T BE. WE TALKED ABOUT A CLEARING HOUSE AND IT NEEDS TO BE PROVIDERS AND PATIENTS. IN VA WE HAVE A CRISIS LINE. A CALL-INNOCENTER FOR WOMEN VETERANS. WE ARE TALKING SMALLER POPULATIONSIGES I THINK WE NEED TO THINK ABOUT A VARIETY OF WAYS WE COULD PROVIDE INFORMATION AND ESPECIALLY IF THERE IS SOME CRITICAL NEED. MAYBE IT'S A SUICIDE MOTHER'S LINE OR POSTPARTUM DEPRESSION MOTHER'S LINE. THERE MIGHT BE SOME SPECIALIZED AREAS WE WOULD WANT TO DO SOMETHING LIKE THAT. WE HAVE A LOT OF VETERANS WITH CHRONIC CONDITIONS AND SELF-MANAGEMENT NEEDS AND SO WE DO A LOT OF RESEARCH WITH BEHAVIOR CHANGE AND IT'S NOT EASY AND CERTAINLY A PAMPHLET DOESN'T DO IT. BUT MAYBE THE FOCUS SHOULD BE ON BETTER INFORMED DECISION-MAKING. I DON'T KNOW THAT BEHAVIOR CHANGE IS WHAT WE ARE TALKING ABOUT. WE NEED TO FOCUS ON PROVIDER PATIENT COMMUNICATION. I THINK TEAM-BASED CARE. EACH IN THE PRIVATE SECTOR, I HAVE A NEW GRANDDAUGHTER AND SO MY DAUGHTR IS GOING TO A LARGE PEDIATRIC PRACTICE. THEY HAVE A LACTATION SPECIALIST AND OTHERS. SO THERE ARE OPPORTUNITIES THAT AS YOU SAID BEFORE, IT'S NOT NECESSARILY A PHYSICIAN THAT WILL BE HAVING THESE CONVERSATIONS. I THINK THE FOCUS SHOULD BE ON PEERS AND IS REALLY IMPORTANT. AND HAVING A MULTIMODAL APPROACH TO -- I THINK WE CAN'T LOSE SITE OF THE FACT THAT THE PATIENT IN THEIR EXPERIENCE -- WE HAVE PROJECTS LIKE FOR HYPERTENSIVE PATIENTS, AFRICAN-AMERICANS. VA HAS PEOPLE LIKE ME, SO I THINK REALLY FOCUSING ON THE PATIENT AND REALIZING THEY COME WITH DIFFERENT ATTITUDES AND KNOWLEDGE AND REFERENCES AND CERTAINLY THERE IS A LITERACY NUMEROUS ISSUES BUT I THINK THAT WE REALLY HAVE TO BE VERY COGNIZANT OF ALL THAT TO THINK OF MULTIPLE CHANNELS WE COULD USE I ALSO LOVE THE UP TO DATE INFORMATION AND I THINK AS WAS MENTIONED BEFORE, WE HAVE TO ASSESS DISSEMINATION AND FIND OUT FROM MOTHERS WHAT INFORMATION THEY WANT. HOW WELL THEY RECEIVE IT. THERE ARE OPPORTUNITIES OF GETTING FEED BOOK A WEBSITE OR SOME OTHER WAYS WHERE YOU'RE NOT ACTUALLY -- SOME WAYS -- [ LOW AUDIO ] >> DR. SPONG: THANK YOU VERY MUCH. I'D LIKE TO OPEN IT UP TO THE ROOM TO ADD ANYTHING IN THAT HADN'T BEEN CAPTURED YET TODAY. ANYTHING YOU WANT TO HIGHLIGHT SPECIFICALLY? DR. BIANCHI? >> THE ONE THING I WASN'T CLEAR ABOUT AND I DO THINK IT'S CRITICAL INFORMATION TO OBTAIN GOING FORWARD IS ANYBODY GOING TO FOLLOW-UP ON -- WE KNOW THERE ARE NO TRIALS ON LACTATION. NO CLINICAL TRIALS. THAT'S CLEAR. ON THE ONES THAT FAILED AND DIDN'T GET COMPLETED, IT WOULD BE GREAT IF WE COULD HAVE A GROUP BEGIN TO INVESTIGATE WHAT HAPPENED TO LEARN FROM OTHERS FAILURES ESSENTIALLY. >> SO, THANK YOU TO DR. GREEN. I ALSO HAVE A LIST OF ALL THE STUDIES. IT'S AN ACTIVITY AND WOULD REQUIRE US TO PULL THE 35 STUDIES IN THE LIST OR ANY THAT MAY HAVE BEEN UPDATED AND IT WOULD BE REVIEWING THROUGH THE INFORMATION THERE. AND I WOULD BE HAPPY TO BE ENGAGED WITH THE TEAM. >> WE HAD A SIDE BAR ON THAT AND I THINK DEBORAH WOULD BE QUITE JUDGED IN THAT AND THAT'S A LITTLE PROJECT THAT'S NOT THAT MANY STUDIES. ONLY 35. ONE OTHER COMMENT I WANTED TO MAKE. DIANA, IT OCCURS TO ME THE PERSON THAT IS MISSING FROM THE TABLE IS SOMEBODY FROM THE EEAP. ONE OF THE LESSONS THAT I LEARNED THE HARD WAY AS AN OBSTETRICIAN WAS ADVISING A WOMAN ABOUT LACTATION ONLY TO HAVE THE PATIENT COME BACK COME BACK AT 6 WEEKS POSTED PARTUM AND I ASKED HER ABOUT YOUR BREAST FREEDING. SHE SAYS I DON'T WANT THE BABY I'M TAKING CARE OF BREASTFEEDING WHILE YOU'RE ON THAT MEDICATION. SO, WE NEED OR YOU NEED A PEDIATRICIAN AS PART OF THIS GROUP. >> I BELIEVE WE HAVE THAT. >> YES. >> AND I'M CHAIR OF THE COMMITTEE FOR DRUGS FOR EAP. >> YOU DIDN'T TELL US THAT. >> I SAID IT YESTERDAY. [ LAUGHS ] >> AND JUST TO BE -- MANY PEOPLE WEAR MANY, MANY HATS. WE DON'T HAVE SPECIFIC REPRESENTATION OF ANY SPECIFIC GROUP ON THE TASK FORCE ITSELF BUT WE TRY TO STRIVE TO HAVE REPRESENTATION ACROSS THE RELEVANT ENTITIES THAT WOULD NEED TO HAVE A VOICE AT THE TABLE. >> BUT I THINK SOMEBODY FROM THE AAP WOULD BE HELPFUL. JUST MY TWO CENTS. >> WE HAVE PEOPLE WHO ARE AAP MEMBERS AND AAP HAT MEMBERS HERE AT THE TABLE BUT AGAIN, WHEN THE TASK FORCE IS FULLY FORMED, WE WON'T HAVE REPRESENTATION FROM SPECIFIC ENTITIES. THEY WILL BE PEOPLE WHO WEAR MANY HATS AND HAVE THE ECK PERRITIES WE HOPE TO PROVIDE WHAT WE NEED AS GUIDANCE. >> VERY QUICKLY, WHY WOULD YOU -- OR WHY ARE YOU GOING THAT PATH AS OPPOSED TO, I WANT A REPRESENTATIVE FROM ACOG OR AAP. I'M CURIOUS IS ALL. >> SO THIS IS APHAKIA COMMITTEE AND THE PACKA COMMITTEE IS APPOINTED BY THE SECRETARY AS PER THE LEGISLATION -- FACA. WHEN YOU PUT THESE TOGETHER YOU WANT TO HAVE SPECIFIC EXPERTISES INCLUDED AND I THINK IT PROBABLY GETS TO BE DIFFICULT IF YOU START -- ONE PERSON MAY WHERE THREE HATS AND ONE PERSON MAY ONLY WEAR ONE HAD HAT AND THEN THERE IS A LOT OF GROUPS WHO MAY WANT TO BE AT THE TABLE AND THERE ARE RESTRICTIONS IN NUMBER S AND SO IT'S A PUZZLE THAT THE SECRETARY GETS TO DO THAT. >> TING IS IMPORTANT TO INCLUDE THE -- ALSO WHERE MY PEDIATRICS CAMP IT IS FORTUNATE INCLUDE ALL HEALTH CARE PROVIDERS AND ELEMENTS OF THE HEALTH CARE SYSTEM THAT WE'LL BE ADDRESSING THESE ISSUES. POINT WELL TAKEN. >> SO, ONE ACTION ITEM FOR US WAS TO LOOK AT THE LABELING OF DRUGS THAT HAVE BEEN APPROVED SINCE THE PLLR WENT INTO EFFECT IN JUNE 30 OF 2015. SO WE INITIATED THAT PROJECT TODAY AND WE SHOULD HAVE SOME RESULTS FOR THE COMMITTEE OR TASK FORCE IN THE NUTURE AND I'D LIKE TO ADD AS WE ARE THINKING ABOUT THE RECOMMENDATIONS FOR RESEARCH COLLABORATION ABOUT CONSISTENT TERMINOLOGY AND ENDPOINTS ACROSS THE AGENCIES AND STAKEHOLDERS S WE ARE THINKING ABOUT LOOKING AT PK/PD DATE AT AND CLINICAL OUTCOMES. THE ENDPOINTS SHOULD BE AGREED UPON, WELL DEFINED, AND SO THAT WE CAN LOOK ACROSS STUDIES OR ACROSS DATA, WHICH IS PART OF THE REAL CHALLENGE THAT WE HAVE RIGHT NOW. WE SOMETIMES ARE TRYING TO COMPARE APPLES AND ORANGES. >> THERESE ROSARIO, UCB. I JUST WANTED TO MAKE A COUPLE OF REMARKS ABOUT LACTATION. I ALSO THINK IT'S VERY IMPORTANT AND WE ALL SAW, WOW, THE NUMBERS WERE IMPRESSIVE. I DID WANT TO MENTION THAT UCB HAS JUST RECENTLY CONDUCTED AND COMPLETED A LACTATION STUDY. SO WE HAVE SOME RECENT KNOW HOW. AND POINT OUT A COUPLE OF THINGS. NUMBER 1, HOW CAN YOU BE SUCCESSFUL IN A STUDY OF DRUGS AND LACTATION? ONE OF THE BIG THINGS WAS YOU NEED TO UNDERSTAND HOW TO GET PATIENTS INTO THE TRIAL AND BRING THE TRIAL TO THE PATIENT. MAKE THAT VERY FRIENDLY FOR THE PATIENT. OUR PARTICIPANTS SAID TO US, THEY WOULD DO IT AGAIN. AND I THINK DID IS ALL ABOUT HOW YOU APPROACH THEM. SO YOU HAVE TO THINK INNOVATIVELY TO SOLVE THE PROBLEM. THE OTHER THING I WANTED TO POINT OUT, SECOND POINT REGARDING LACTATION, RESOURCES. I KNOW THAT CHRIS 13A CHAMBERS -- - CHRISTINA CHAMBERS IN SAN DIEGO, SHE HAS JUST START ED THE BREAST MILK BIOBANK. ALSO ONE OF THE AMBITIONS, AND I KNOW THAT CHRISTINA MENTIONED THIS EARLIER ABOUT THE IMI CONCEPTION PROJECT THAT SHOULD HAVE ALSO THE AMBITION TO CREATE A BIOBANK THAT WOULD ALLOW FOR A LITTLE BIT MORE THAN WHAT WE HAVE NOW REGARDING OPPORTUNISTIC SAMPLING SO THAT THE KEY IN ALL OF THIS IS HAVING GREAT BIOANALYTICS AND THAT COMES FROM INDUSTRY. >> THANK YOU VERY MUCH. ANY OTHER QUESTIONS OR THOUGHTS? IF NOT I WILL PUT UP WHAT I REFLECTED AND HEARD. >> I'LL BE HAPPY TO PROVIDE -- >> CAN I ADDRESS THAT REALLY QUICKLY. SO THE CRITICAL PATH INSTITUTE NEONATAL CONSORTIUM JUST PUBLISHED INTERNATIONAL WHITE PAPER WHICH INCLUDED AN OFFICIAL DEFINITION OF NEONATES AND CONSIDERING THAT THAT WERE CONCLUDED THE WORK OF THE FDA, EMA, AND MHLW IN JAPAN, HEALTH CANADA, AMONG SOME OF THE AGENCIES IN RECOGNIZING THE DEFINITION, IT WAS ALSO USED AS THE BASIS FOR THE CLARIFICATION ON NEONATAL DEFINITION AND THE RECENT ICH INTERNATIONAL CONFERENCE ON HARMONIZATION E11 GUIDANCE FOR PEDIATRICS, THAT WE SHOULD DEFAULTED OR AT BEST TRY TO DEFAULT TO THOSE DEFINITIONS SINCE THEY ARE NOW ALIGNED AND INTERNATIONALLY RECOGNIZED. >> I CAN ALSO SAY THAT A COG HAS DONE SOME HARMONIZATION AMONG A NUMBER OF TERMS AS WELL AND COORDINATED THAT ACROSS A NUMBER OF DIFFERENT GROUPS. SO I THINK THERE IS LOTS OF DEFINITIONS THROUGHOUT AND THE QUESTION IS GOING TO BE HOW TO MOVE FORWARD WITH IT. >> THANK YOU. SHEILA FROM THE AMERICAN ACADEMY OF ALLERGY, ASTHMA AND IMMUNOLOGY HERE TODAY ON BEHALF OF VAMPS. WHAT I MOSTLY WANT TO DO IS APOLOGIZE THAT I'M HERE INSTEAD OF TINA CHAMBERS. SHE JUST CAME UP IN CONVERSATIONS AND I HAVE BEEN THINKING THE LAST TWO DAYS, WE NEEDED TINA HERE. AND I WILL WORK ON THAT TO SEE IF WE CAN'T GET HER TO SUBSEQUENT MEETINGS OF THE GROUP. BECAUSE AGAIN AND AGAIN, THE LAST TWO DAYS, I KEEP HEARING THINGS THAT PEOPLE ARE COMMENTING, WE GOT TO FIGURE OUT HOW TO DO THIS AND HOW DO WE DO THIS IN I AND KEEP WANTING TO SAY VAMPS DOES THAT. VAMPS DOES THAT. I KNOW A LOT OF YOU ARE FAMILIAR WITH VAMPS. I DON'T KNOW THAT EVERYONE IS SO I WANT TO PUT THAT PLUG IN REAL QUICK BECAUSE WE ARE DOING THE DISEASE-LEVEL DATA COLLECTION INSTEAD OF DRUGS AND SILOS. WE ARE UNDERGOING THAT PROCESS. IT IS A PUBLIC-PRIVATE PARTNERSHIP IT'S BEEN UP AND RUNNING A GOOD LONG TIME NOW IT'S GOT THE HISTORY. IT'S GOT THE RESULTS. WE HAVE GOT THE DATA COLLECTION THAT SHOWS THE OUTCOMES. WE ARE TALKING TO THE PREGNANT WOMEN. WE ARE TALKING TO THEM ABOUT WHAT THEY WANT TO BE A PART OF. AND THAT'S WHERE THE DATA COLLECTION IS RATHER THAN TAKING THE DOCTOR'S TIME. AND JUST TO THROW IT OUT THERE, WE ARE ACTUALLY PLANING ANOTHER IN A SERIES OF WEBINARS ON THE UPDATED RULE FOR THE LAKE LABEL AND IF ANYBODY IS INTERESTED IN FINDING OUT MORE ABOUT VAMPS AND FINDING OUT ADDITIONAL INFORMATION ON THE ROLLOUT OF THE LABEL, WE ARE GOING TO BE WORKING ON THAT AND I WOULD LOVE TO HAVE ANYBODY WHO IS INTERESTED BE A PART OF THAT AND SHARE THAT INFORMATION WITH YOU. SO THANK YOU. >> I AGREE. THE MOTHER TO BABY WEBSITE HAS FACT SHEETS ON MANY MEDICATION THAT IS GO THROUGH A LOT OF THE DIFFERENT CONSIDERATIONS. SO I WOULD ECHO THAT SENTIMENT. >> THANK YOU VERY MUCH. VERY HELPFUL. SO, AGAIN THIS WAS WHAT THIS TASK FORCE WAS TRYING TO COVER AND WE CERTAINLY I THINK DID THAT IN MANY DIFFERENT WAYS. WHAT I JUST HEARD IN THIS LAST SET OF DISCUSSIONS COME I DID NOT HARMONIZE WITH THE PRIOR SUMMARIES, SO MY APOLOGIES TO THAT BUT JUST TO HIGHLIGHT. THE STATE OF THE RESEARCH STATISTICS ARE STRIKING. THIS IS A BIG IMPACT ISSUE AND IT WILL BE IMPORTANT AS WE PUT THIS REPORT TOGETHER TO REALLY TAKE PEOPLE THROUGH SPECIFIC CASE STUDIES TO BE ABLE TO SHOW WHAT THOSE GAPS ARE BECAUSE THAT PERSONAL VOICE IS SO COMPELLING. WE DO HAVE SOME INFORMATION, INFORMATION ABOUT PHYSIOLOGIC CHANGES THAT WE CAN HIGHLIGHT, IMPORTANT TO KNOW WHAT THE IS THE WALTY OF THE INFORMATION AVAILABLE AND INVESTIGATE THE STUDIES THAT WERE NOT COMPLETED. COORDINATION COLLABORATION. IT WOULD BE ENTIRABLE TO HAVE INFRASTRUCTURE TO SHARE TECHNIQUES AND STUDIES THAT ARE ACROSS FEDERAL AGENCIES. THE CLINICAL TRIAL NETWORKS ARE REALLY ESSENTIAL TO CONDUCT MUCH OF THE WORK. IT WILL BE IMPORTANT TO BUILD ON THESE EXISTING SUCCESSFUL NETWORK. TO EXPLORE OPPORTUNISTIC STUDIES, MODELING AND SIMULATION OF DESIGNS, DATA COLLABORATION OF WAREHOUSE THAT IS IS PUBLICLY AVAILABLE. INCENTIVES TO ENGAGE OTHER AND AGENCIES AS WELL AS AND FACILITATE THAT COLLABORATION. LEVERAGING REAL-WORLD INFORMATION: [ READING ] DISSEMINATION, WE NEED TO INCORPORATE NEW MODELS OF DISSEMINATION AND GETTING OUR INFORMATION OUT AND REALIZING THAT PEOPLE ACCEPT INFORMATION IN DIFFERENT WAYS AND THERE IS DIFFERENT HEALTH LITERACY LEVELS ACROSS THOSE DIFFERENT GROUPS SO A LOT INSTEAD OF JUST HAVING TWO PIECES OF INFORMATION THAT WE NEED, WE ARE GOING TO NEED TO HAVE MULTIPLE WAYS TO DO THIS. WE NEED TO COLLABORATE WITH ON LINE SITES WITH WHAT PEOPLE ARE ALREADY USING. AGAIN THAT HEALTH LITERACY COMPONENT. LOTS OF PEOPLE GETTING INFORMATION FOR BOTH PREGNANCY AND LACTATION FROM GOING AND WE NEED TO TAP INTO THAT -- GOOGLE. COMMUNICATION STRATEGIES NEEDS TO BE OUTLINED AND NEEDS TO BE CONSISTENT ACROSS VENUES AND NEED TOWED INCLUDE PEERS IN THE DISSEMINATION PROCESS AND WE NEED TO HAVE PATIENT-SPECIFIC INFORMATION. JUST SOME GENERAL POINTS FROM THE SUMMARY. WE NEED TO DEFINE WHAT IS SUCCESS FOR THE TASK FORCE AS WE NULL TOGETHER. AND CREATE A DOCUMENT THAT HAS ACTIONABLE ITEMS. WE NEED TO FOCUS AGAIN ON THE UNMET MEDICAL NEED. WHAT DOES THE PATIENT NEED? AND TALKING THROUGH THAT IDEA OF NOT ONLY THE COMMON THINGS BUT THE CRITICAL THINGS. AND THEN THIS TIERED APPROACH TO THERAPIES IN THE REPORT TO PROVIDE PATHWAYS FOR GAPS BASED ON THERAPIES. WITH THAT, I WANT TO THANK YOU. I THINK WE HAVE GREAT INFORMATION. I THINK WE HAVE CERTAINLY COVERED THESE FOUR AREAS. WE COVERED ONE OF THE FIVE TASKS FOR THE TASK FORCE. OUR GOAL IS TO PULL THIS TOGETHER IN A SUMMARY DOCUMENT. AND AT THE BEGINNING OF THE NEXT TASK FORCE MEETING, WE WILL WALK THROUGH THAT DOCUMENT AND ADD AND TAKE BACK SOME THINGS TO BE ABLE TO REALLY CRAFT THAT FIRST PART OF THE REPORT. AND WE WILL TACKLE THE DIFFERENT ISSUES. WE WILL TACKLE MOST LIKELY TACKLE THE ETHICAL ISSUES IN THE NEXT MEETING AND I LOOK FORWARD TO SEEING EVERYONE IN NOVEMBER. FEBRUARY AS WELL. BUT ALSO NOVEMBER. NOVEMBER AND FEBRUARY. AND I WANT TO THANK YOU ALL FOR YOUR TIME BECAUSE I KNOW YOU ARE VERY, VERY BUSY PEOPLE AND I WANT TO THANK YOU ALL FOR YOUR PASSION BECAUSE I THINK TOGETHER WE WILL BE ABLE TO REALLY PUT TOGETHER THE BEST REPORT POSSIBLE FOR THE SECRETARY BY SENT OF 2018. SO THANK YOU AND SAFE TRAVELS WHETHER YOU'RE TRAVELING FAR OR TRAVELING NEAR. WITH THAT, I WILL END THE TASK FORCE. [ APPLAUSE ]