>>WELCOME TO THE OPEN SESSION OF THE NIDCD ADVISORY COUNCIL. AS A REMINDER, THE OPEN SESSION IS BEING RECORDED AND VIDEO CAST LIFE AND WILL BE ARCHIVED FOR LATER VIEWING BY MEMBERS OF THE PUBLIC AND THE NIH STAFF FOR ONE YEAR. SO, WE WILL BEGIN THE MEETING WITH INTRODUCTIONS OF THE COUNCIL MEMBERS. I'LL CALL ON EACH MEMBER AND ASK YOU TO STATE YOUR NAME AND YOUR AFFILIATION AND JUST GIVE A BRIEF SYNOPSIS OF YOUR EXPERTISE. SO, WE'LL START WITH Dr. EMILY BUSE. >> WE WILL SKIP EMILY. >> HELLO, I'M A PROFESSOR AT THE UNIVERSITY OF MIAMI SCHOOL OF MEDICINE AND I'M A PROFESSOR OF PHYSIOLOGY AND BIOPHYSICS AND I STUDY SENSORY OF PROCESSING FOR TASTE AND SMELL, MOSTLY OUT IN THE PERIPHERY AND THE NEURONS THAT CARRY THE SENSORY SIGNAL TO THE BRAIN. >> Dr. Debara Tucci: Ms. VICKY DILL-WILLIAMS. >> I'M THE C.E.O. OF THE AMERICAN SPEECH LANGUAGE HEARING ASSOCIATION. BY TRAINING I AM BOTH THE ASSOCIATION EXECUTIVE AND A SPEECH LANGUAGE PATHOLOGIST AND MY SUBJECT MATTER EXPERTISE IN COMMUNICATIONS SCIENCE IS IN DISORDERS RELATES SPECIFICALLY TO CULTURAL AND LINGUISTIC INFLUENCES ON COMMUNICATION AND DISORDERS. >> Dr. Debara Tucci: THANK YOU. Dr. RUTH ANNE ETOCH. >> HI, I REPRESENT -- >> YOU ARE THERE, OK. >> NAME A PROFESSOR OF NEUROBIOLOGY AT THE UNIVERSITY OF CHICAGO. MY LABORATORY INVESTIGATES HAIR CELL GENERATION IN COLLABORATION WITH OTHERS SO WE'RE INTERESTED IN INNER EAR PROCESSING WITH THE VESTIBULAR PART OF THE EAR FOCUS. >> Dr. Debara Tucci: THANK YOU. Mr. RICHARD EINHORN. >> HI. I'M RICHARD AND I'M A COMPOSER BY TRADE AND I HAVE SEVERAL DIFFERENT KINDS OF HEARING LOSS. I AM A ADVOCATE AND CONSULTANT FOR BETTER HEARING TECHNOLOGY. I'M THE PAST PRESIDENT -- PAST HEAD OF THE BOARD OF HEARING LOSS ASSOCIATION OF AMERICA AND I CONSULT REGULARLY, WRITE ARTICLES, DO INTERVIEWS ON THE TOPIC OF ASSISTED LISTED TECHNOLOGY. >> Dr. Debara Tucci: THANK YOU. Dr. CAROLE ESBIE-WILSON. >> I DON'T SEE HER ON YET. Dr. LISA GOFFMAN. >> I'M PROFESSOR AT THE COMMUNICATION DISORDERS IN THE SCHOOL OF BEHAVIORAL AND BRIAN SCIENCES AT THE UNIVERSITY OF TEXAS DALLAS. I STUDY TYPICAL AND A TYPICAL SPEECH MOTOR DEVELOPMENT. IN OUR LAB, WE'RE FOCUSING ON GENERAL COGNITIVE CAPACITIES THAT CONTRIBUTE TO DEFICITS IN DEVELOPMENTAL DISORDERS ESPECIALLY PATTERN INDUCTION AND SEQUENTIAL ORGANIZATIONS. GREAT TO SEE EVERYBODY. >> MY NAME IS ANDY AND I'M A PROFESSOR OF NEUROSCIENCE AND MOLECULAR GENETICS IN HOUSTON, TEXAS. AND OUR RESEARCH FOCUSES ON THE DEVELOPMENT, REGENERATION AND EVOLUTION OF THE INNER EAR. >> Dr. Debara Tucci: THANK YOU. Dr. ARGYE HILLIS. >> HELLO. I'M Dr. HILLIS A PROFESSOR OF NEUROLOGY AT JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE. I STUDY RECOVERY OF LANGUAGE AND COGNITIVE FUNCTIONS AFTER STROKE ESPECIALLY IN THE FIRST YEAR AFTER STROKE USING LONGITUDINAL BEHAVIORAL TESTING AND LONGITUDINAL IMAGING OF VARIOUS TYPES AND I ALSO RUN CLINICAL TRIALS FOR TREATMENT OF APHASIA LANGUAGE PROBLEMS AFTER STROKE. >> Dr. Debara Tucci: THANK YOU. Dr. HILL MAN IS NEXT AND HE WASN'T ABLE TO JOIN US FOR THE SESSION THIS AFTERNOON. SO WE'LL MOVE TO Ms. BARBRA KELLY. >> HI I'M BARBARA KELLY EXECUTIVE DIRECTOR OF HEARING LOWS ASSOCIATION OF AMERICA. WE'RE LOCATED IN ROCKVILLE MARYLAND AND PEOPLE WITH HEARING LOSS AND WE PROVIDE INFORMATION, EDUCATION, SUPPORT AND ADVOCACY AND WE HAVE LOCAL CHAPTERS ACROSS THE COUNTRY AND WE'RE INTERESTED IN RESEARCH TO RESTORE HEARING, RESEARCH THAT MITIGATES THE EFFECTS OF HEARING LOSS AND THERAPIES WHETHER THEY'RE TECHNOLOGY THERAPIES OR FORM PHARMACEUTICAL. >> GOOD AFTERNOON, EVERYONE. PROFESSOR OF MECHANICAL ENGINEERING AS WELL AS ASSOCIATE DEAN FOR STUDENT RESEARCH AT COLOMBIA COLLEGE OF SURGEONS AND I BRING CLINICAL EXPERTISE WITH EAR DISEASES SUCH AS COCHLEAR IMPLANT AND DISTURBANCE AND SO ON AND MY SPECIAL INTEREST IS INNER EAR THERAPY AND DESIGNING TOOLS THAT MAKE INNER EAR DIAGNOSTICS AND INNER EAR DELIVERY POSSIBLE. >> Dr. Debara Tucci: THANK YOU. Dr. CYNTHIA MORTON. >> HI, I'M CYNTHIA MORTON AND I'M A MEDICAL GENETICIST AND A PROFESSOR AT HARVARD MEDICAL SCHOOL IN BOSTON. I'M INTERESTED IN NEWBORN HEARING SCREENING AND BROADLY THE GENETICS UNDERLYING CONGENITAL HEARING LOSS AND AGE RELATED HEARING LOSS. >> THANK YOU. Ms. LYNN MURPHY GREEN. >> HI, I'M LYNN MURPHY GRO GREED I'M AN ATTORNEY WHO WORKS FOR FIDELITY NATIONAL FINANCIAL IN-HOUSE ROLE. FOR TITLE INSURANCE AND REAL ESTATE MATTERS. I AM INTERESTED IN HEARING LOSS, THE EARLY IDENTIFICATION OF CHILDREN WITH HEARING LOSS, PRELINGUAL HEARING LOSS AND THE DEVELOPMENT OF SPEECH AND IN PARTICULAR ADVOCACY FOR THE DEAF-BLIND COMMUNITY AND VOLUNTEER AND INVOLVED IN SEVERAL ORGANIZATIONS WITH ADVOCACY FOR THOSE GROUPS. THANK YOU. >> THANK YOU. Dr. DAN SANES WAS NOT ABLE TO JOIN US SO NEXT Dr. BEN STROBRIDGE. >> HI. I'M PROFESSOR OF NEUROSCIENCE AND PHYSIOLOGY BIOPHYSICS AT CASE WESTERN RENERVE UNIVERSITY IN CLEVELAND AND HIGH GROUP WORKS ON SYNAPTIC PHYSIOLOGY AND HOW LOCAL CIRCUITS FUNCTION IN DIFFERENT BRAIN REGIONS INCLUDING THE OFACTORY BULB WHERE WE WORKED FOR A COUPLE OF DECADES. >> Dr. Debara Tucci: Dr. MEG WALLHAGGEN. >> GOOD MORNING. THIS IS MEG AND I'M A PROFESSOR IN THE SCHOOL OF NURSING AT UNIVERSITY OF CALIFORNIA IN SAN FRANCISCO AND I'M VERY INTERESTED IN AGE-RELATED CHANGES WITH HEARING THE EXPERIENCE OF HEARING LOSS FOR PERSONS WHO HAVE HEARING DIFFICULTIES BUT ALSO LOCKING AT THE WAY IN WHICH HEARING LOSS EFFECTS COMMUNICATIONS WITHIN THE HEALTHCARE SETTINGS AND TRYING TO GET HEALTHCARE PRACTITIONERS TO UNDERSTAND THE EXPERIENCES OF HEARING AND WHY IT'S SO IMPORTANT FOR THEM TO PAY ATTENTION TO IT. THANK YOU. I'M VERY PLEASED TO BE PART OF THIS. >> Dr. Debara Tucci: THANK YOU. Dr. WES, ARE YOU ON? >> I AM, I AM. I'M EMILY BUSE A PROFESSOR AT THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL. I DO RESEARCH WITH HUMAN HEARING STUDYING HEARING A CROSS THE LIFESPAN INCLUDING AUDITORY DEVELOPMENT AND AGING SPELLS HEARING LOSS AND THE USE OF HEARING AIDS AND COCHLEAR IMPLANTS. >> THANK YOU. Dr. SB WILSON. >> HELLO. I'M CARO WILSON A PROFESSOR IN THE ELECTRICAL COMPUTER ENGINEERING DEPARTMENT IN THE INSTITUTE FOR SYSTEMS RESEARCH AT THE UNIVERSITY OF MARYLAND IN COLLEGE PARK. I HAVE A SPEECH COMMUNICATION LAB THERE AND WE LOOK AT SPEECH PRODUCTION, SPEECH PERCEPTION, AND DEVELOPING ALL KINDS OF TOOLS TO IMPROVE DIGITAL SPEECH PROCESSING. FOR EXAMPLE, REMOVING BACKGROUND NOISE SO YOU CAN HEAR BETTER BUT ALSO TO IMPROVE SPEECH RECOGNITION SYSTEMS AND MORE RECENTLY WE'VE BEEN LOOKING AT SPEECH AS A BEHAVIORAL SIGNAL TO DO EMOTION RECOGNITION DETECTION AND DETECTION OF MENTAL HEALTH ISSUES. >> GREAT, THANK YOU. AND WE HAVE SEVERAL AD HOC MEMBERS WITH US TODAY. FIRST, Ms. CATHERINE BOUGHTEN. >> HI, I'M CATHERINE AND I HAVE PROGRESSIVE BILATERAL HEARING LOSS THAT STARTED WHEN I WAS 30. WHICH IS QUITE A LONG TIME AGO NOW. I WEAR A COCHLEAR IMPLANT AND A HEARING AID. BY PROFESSION I WAS AN EDITOR AND WORKED AT THE "NEW YORK TIMES" FOR 22 YEARS. AFTER I RETIRED, I STARTED WRITING ABOUT HEARING LOSS. I'VE WRITTEN THREE BOOKS ABOUT HEARING LOSS. ONE A MEMOIR ABOUT WHAT IT'S LIKE TO LOSE YOUR HEARING IN MID LIFE. AND TWO OTHERS THAT ARE MORE ADVICE BOOKS. I HAVE SERVED ON THE BOARD OF THE HEARING LOSS ASSOCIATION, THE NATIONAL BOARD FOR TWO AND A HALF TERMS AND I AM THE PRESIDENT OF THE NEW YORK CITY CHAPTER OF THE HEARING LOSS ASSOCIATION. AND I'M VERY GLAD TO BE HERE. I'M ALREADY LEARNED A TREMENDOUS AMOUNT. THANK YOU. >> Dr. Debara Tucci: THANK YOU. Dr. MELINDA PETTIGREW. >> HI, THANK YOU. I'M REALLY EXCITED TO BE HERE. SO, I'M MELINDA PETTY GREW AND I'M A PROFESSOR OF EPIDEMIOLOGY MAYBE ROBE Y'ALL DISEASES AND I'M A EPIDEMIOLOGIST BY TRAINING WITH A SPECIAL FOCUS ON GENOME I CAN EPIDEMIOLOGY AND RESPIRATORY PATHOGENS THOSE ASSOCIATED WITH ACUTE AND CHRONIC OTUS MEDIA. >> Dr. Debara Tucci: Dr. DANIEL MERFIELD. >> HI, GREAT TO JOIN YOU. I'M A PROFESSOR OF HEAD AND NECK SURGERY AT THE OHIO STATE UNIVERSITY WITH A FILL AT POSITIONS IN BIOMEDICAL ENGINEERING, SPEECH AND HEARING SCIENCES AND REHAB SCIENCES. MY INTERESTS ARE ANYTHING RELATED TO THE VESTIBULAR PHYSIOLOGY AND MY SPECIFIC INTEREST THESE DAYS HAVE SHIFTED IN THE DIRECTION OF THE CONTRIBUTIONS OF THE STICK YOU LAR FUNCTION INCLUDING MULTI SENSORY INTEGRATION TO HUMAN BEHAVIOR, INCLUDING BUT NOT LIMITED TO BALANCE. AND ALSO HOW WE MIGHT, IN THE FUTURE, USE SOME OF THESE NEW TECHNIQUES TO IMPROVE PATIENT DIAGNOSIS. THANK YOU. >> THANK YOU. Dr. SUSAN TEBOW. >> I'M HAPPY TO BE HERE. I AM A PROFESSOR IN THE DEPARTMENT OF SURGERY. WITH APPOINTMENTS IN BIOMEDICAL ENGINEERING AND COMMUNICATIONS SCIENCES AND DISORDERS AT THE UNIVERSITY OF WISCONSIN MADISON. MY LAB HAS EXPERTISE IN UNDERSTANDING THE BOYOLOGY OF THE PEW COWS A LOOKING AT TISSUE REGENERATION, DEVELOPMENT OF THE LARYNX. >> WE HAVE THREE EX-OFFICIO MEMBERS. Dr. JUDY SCHAFFER FOR Dr. BECK AT THE V.A. >> I DON'T THINK JUDY IS ON YET. >> Dr. Debara Tucci: ALL RIGHT. Dr. JEREMY NELSON. >> I DON'T THINK JEREMY IS HERE YET. >> Dr. Debara Tucci: Ms. CHRISTIE THEMEAN. >> SHE'S HERE. >> Dr. Debara Tucci: HI, CHRISTIE. >> I'M AN AUDIOLOGIST AT THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH IN CINCINNATI. OUR GROUP IS PRIMARILY WORKS ON HEARING LOSS PREVENTION RESEARCH FOR WORKERS EXPOSES TO NOISE AND OTHER TOXICANTS AND MY WORK OVER THE LAST LONGER THAN I WANT TO SAY, HAS BEEN IN THE EPIDEMIOLOGY OF HEARING LOSS, MANAGING HEARING TESTING FOR LARGE-SCALE STUDIES INCLUDING THE EARLY CHILDHOOD LONGITUDINAL SURVEY WHICH HAS BEEN DONE THROUGH A FANTASTIC COLLABORATION BETWEEN NIDCD. >> Dr. Debara Tucci: THANK YOU FOR JOINING. WE'LL MOVE TO CONSIDERATION OF THE MINUTES FROM THE PREVIOUSLY COUNCIL MEETING SO THE MINUTES OF THE MAY COUNCIL MEETING WITH RECENTLY POSTED TO THE ADVISORY COUNCIL WEBSITE AND ARE THERE ANY ADDITIONS OR CORRECTIONS TO THE MINUTES? IS HAD A MOTION TO APPROVE? >> I APPROVE. >> Dr. Debara Tucci: THANK YOU. >> AND A SECOND. >> Dr. Debara Tucci: ALL RIGHT. THANK YOU VERY MUCH. AND NOW FOR DATES FOR FUTURE COUNCIL MEETINGS. SO, AS MOST OF YOU KNOW, WE HAVE INTENDED TO HAVE THIS AS AN IN-PERSON MEETING, OUR FIRST INPERSON MEETING IN A COUPLE OF YEARS AND DUE TO THE RISING RATES OF CORONAVIRUS IN THE COMMUNITY, WE WERE FORCED TO JUST SWITCH AT THE LAST MINUTE TO VIRTUAL. SO, APOLOGIES TO ALL OF YOU FOR THE CHANGE IN TRAVEL PLANS. WE VERY MUCH HOPE TO BE ABLE TO GO BACK TO AN INPERSON MEETING IN THE FUTURE BUT THE NEXT MEETING WHICH IS SCHEDULED FOR FEBRUARY 2 TO 3, IS ACTUALLY GOING TO BE VIRTUAL. WE HAD MADE A DECISION BASED ON THE FACT THAT THE VIRTUAL MEETINGS SEEM TO BE GOING PRETTY WELL, THAT WE WOULD HAVE AT LEAST ONE MEETING A YEAR BE VIRTUAL AND THE WINTER MEETING DUE TO THE TRAVEL DIFFICULTIES SEEM LIKE THE LOGICAL CHOICE. SO AT THIS POINT, WE'RE PLANNING ON HAVING THIS AS A VIRTUAL MEETING. THIS IS LATER THAN WE USUALLY HOLD THE MEETING AND THEN WE VERY MUCH HOPE TO SEE ALL OF YOU IN-PERSON FOR THE MAY COUNCIL MEETING AS SHOWN HERE. LET US KNOW IF YOU SEE PROBLEMS WITH THE DATES FOR THESE FUTURE MEETINGS. I WANT TO GIVE YOU HIGHLIGHTS FROM THE NIDCD AS WELL AS ACROSS THE NIH AND I'D LIKE TO START, NEXT SLIDE, WITH A VERY EXCITING ANNOUNCEMENT. I AM ABSOLUTELY THRILLED TO ANNOUNCE THE APPOINTMENT OF NIDCD'S FIRST CHIEF DIVERSITY OFFICER. WE HAVE RECENTLY EXTENDED AN OFFER TO Dr. CENDRINE ROBINSON AND SHE'LL JOIN US NEXT WEEK. SO, AS YOU KNOW, EXPANDING DIVERSITY, EQUITY, INCLUSION AND ACCESSIBILITY WITHIN THE NIDCD AND OUR INTRAMURAL AND EXTRAMURAL WORKFORCE HAS BEEN A PRIORITY FOR ME SINCE COMING TO THE NIDCD IN 2019. THIS IS A GOAL THAT SHARED BY ALL NICHD LEADERSHIP AND WE BEGAN TO PLAN FOR THIS POSITION ACTUALLY SHORTLY AFTER MY ARRIVAL THREE YEARS AGO. A LITTLE BIT OF BACKGROUND ON Dr. ROBINSON. SHE JOINS US FROM THE DEPARTMENT OF VETERAN AFFAIRS WHERE SHE SERVED AS A SCIENTIFIC PROGRAM OFFICER AND DIVERSITY EQUITY AND INCLUSION CHAIR SINCE 2020. IN THIS POSITION, SHE DEVELOPED AND EXECUTED INITIATIVES TO EXPAND THE PIPELINE OF RESEARCHERS FROM HISTORICALLY EXCLUDED GROUPS, AND TO PROMOTE HEALTH EQUITY. SHE DEVELOPED POLICY RECOMMENDATIONS AND FORGED STRATEGIC PARTNERSHIPS, CREATED AND MANAGED A STAKEHOLDER ADVISORY BOARD, DEVELOPED FUNDING ANNOUNCEMENTS FOR THE V.A. OFFICE OF RESEARCH AND DEVELOPMENT, DIVERSITY RESEARCH SUPPLEMENT AND SHE DIRECTED THE IMPLEMENTATION OF SUMMER RESEARCH PROGRAMS IN 21 V.A. MEDICAL CENTERS. PRIOR TO JOINING THE V.A. Dr. ROBINSON WORKED AT THE NATIONAL CANCER INSTITUTE TOBACCO CONTROL RESEARCH BRANCH, CANCER PREVENTION FELLOWSHIP PROGRAM AS A CANCER PREVENTION FELLOW AND AS THE PROJECT MANAGER FOR THE SMOKE-FREE.GOV INITIATIVE. EARLIER IN HER CAREER, Dr. ROBINSON WAS A CYTOLOGY RESIDENT AND A RESEARCH -- PSYCHOLOGY RESIDENT AND RESEARCH FOAL AT THE EDWARD HINDS V.A. HOSPITAL AND A GRADUATE RESEARCH FELLOW AT THE UNIFORM SERVICES UNIVERSITY OF HEALTH SCIENCES HERE IN BETHESDA. Dr. ROBINSON RECEIVED HER BACHELOR'S DEGREE IN BRAIN AND COGNITIVE SCIENCES FROM THE UNIVERSITY OF ROCHESTER AND A MASTERS IN DOCTORAL DEGREE IN MEDICAL AND CLINICAL CYTOLOGY AND A MASTERS OF PUBLIC-HEALTH DEGREE IN QUANTITIVE METHODS FROM THE HARVARD SCHOOL OF PUBLIC-HEALTH. SHE'S A MEMBER OF THE AMERICAN PSYCHOLOGICAL ASSOCIATION HEALTH DISPARITIES COMMITTEE AND A MENTORING PROGRAM CHAIR FOR THE SOCIETY FOR RESEARCH ON NICOTINE AND TOBACCO. AS YOU CAN SEE, SHE'S EXCEPTIONALLY WELL QUALIFIED TO LEAD THE NIDCD'S EFFORTS IN THIS REGARD AND TO COLLABORATE WITH OTHERS ACROSS THE NIH AND THE MANY EFFORTS THAT ARE ON GOING CURRENTLY. I'M ABSOLUTELY THRILLED THAT WE WILL BE LED IN THESE EFFORTS BY SUCH AN ACCOMPLISHED AND FORWARD-THINKING CHIEF DIVERSITY OFFICER. TOGETHER, WE'LL BUILD AND MAINTAIN A CULTURE OF INCLUS INCLUSIVENESS THROUGHOUT OUR COMMUNITIES AND WE'RE LOOKING FORWARD TO HAVING HER ON BOARD LATER THIS MONTH. IN ADDITION TO Dr. ROBINSON, WE HAVE OTHER NEW STAFF WHO HAVE RECENTLY JOINED THE INSTITUTE AND WE'LL INTRODUCE THESE NEW STAFF TO YOU WHEN JUDITH COOPER, BECKY AND LISA REPORT ABOUT THEIR RESPECTED DIVISIONS LATER IN THE MEETING. SO OUR SEARCH TO RECRUIT A NEW CLINICAL DIRECTOR IS UNDERWAY AND AN INITIAL ROUND OF INTERVIEWS HAVE OCCURRED. CANDIDATES HAVE BEEN ADVANCED IN THIS PROCESS AND WILL COME TO THE NIH CAMPUS FOR HYBRID INTERVIEWS AND THE NEXT COUPLE OF MONTHS. AS OUR RECRUITMENT IS OCCURRING, Dr. CLINT ALLEN, IS SEARCHING AS NIDCD'S ACTING CLINICAL DIRECTOR. Dr. ALLEN ALSO SERVES AS THE TENURED PRINCIPLE INVESTIGATOR IN THE SECTION ON TRANSLATIONAL TUMOR BIOLOGY. HIS LAB IS STUDYING VARIOUS THERAPEUTIC APPROACHES TO REVERSE LOCAL IMMUNO SUPPRESSION WITHIN THE TUMOR MICRO ENVIRONMENT TO ENHANCE RESPONSES TO IMMUNE-ACT TA RATE ISING ANTI-CANNER TREATMENTS. HE HOLDS A FACULTY APPOINTMENT ALSO IN THE DEPARTMENT OF HEAD AND NECK SURGERY AT HOPKINS AND HE HAS A CLINICAL PRACTICE IN BETHESDA AND ALSO IN OUR IN-PATIENT CONSULTATION TEAM AT THE NIH CLINICAL CENTER. HE JOINS NIDCD AS AN INVESTIGATOR IN THE SURGEON SCIENTIST PROGRAM IN 2013 I'M GRATEFUL TO Dr. ALLEN FOR HIS SERVICE AND HIS WILLINGNESS TO TAKE ON THIS ROLE. ON FRIDAY, NEXT SLIDE, PLEASE, FRIDAY SEPTEMBER 30th, NIDCD WILL HOST A HYBRID RETIREMENT SYMPOSIUM CELEBRATING THE CAREER OF Dr. CARMEN BREWER, CHIEF RESEARCH AUDIOLOGIST OF THE NIDCD AND CHIEF OF OUR AUDIOLOGY UNIT. THIS HALF-DAY SYMPOSIUM WILL HIGHLIGHT THE GREAT IMPACT THAT Dr. BREWER HAS HAD ON THE NIDCD CLINICAL PROGRAMS AND THE CRITICAL CONTRIBUTIONS SHE'S MADE TO AUDIOLOGY RESEARCH INTERNATIONALLY. Dr. BREWER HAS BEEN AT NIDCD FOR 20 YEARS. UNDER HER LEADERSHIP, CARMEN EXPANDED THE AUDIOLOGY UNITS RESEARCH PRODUCTIVITY AND DEVELOPED A COMPREHENSIVE MENTORING PROGRAM. SHE WILL BE RETIRING IN OCTOBER. IF YOU'D LIKE TO ATTEND THIS SYMPOSIUM VIRTUALLY, PLEASE CONTACT ALICIA AT THE ADDRESS SHOWN HERE AND RECRUITMENT IS CURRENTLY UNDERWAY FOR CARMEN'S REPLACEMENT. WE WILL GREATLY MISS CARMEN. HER LEADERSHIP AND HER CLINICAL EXPERTISE AND THANK HER FOR HER MANY, MANY YEARS OF EXTREMELY PRODUCTIVE SERVICE. AND NEXT -- IT'S WITH GREAT SADNESS WE LEARNED ABOUT THE PASSING OF THESE COLLEAGUES WHO PLAYED GREAT ROLES IN SHAPING NIDCD. FIRST, FORMER NIDCD DIRECTOR Dr. JAMES BYRON SNOW JUNIOR PASSED AWAY ON MAY 28th. Dr. SNOW MADE SIGNIFICANT CONTRIBUTIONS TO RESEARCH AND CLINICAL PRACTICE AND WAS CONSIDERED A PIONEER IN THE FIELD. BEGINNING IN FEBRUARY, 1990, HE SERVED AS THE NIDCD FIRST OFFICIAL DIRECTOR SUCCEEDING ACTING DIRECTOR JAY MASSCOWITS, HE RECRUITED A CADRAY OF SCIENTISTS ENCOURAGING THE APPLICATION OF MOLECULAR BIOLOGY TO THE STUDIES OF DISORDERS OF HUMAN COMMUNICATION. IN 1990, HE ESTABLISHED THE NIDCD'S DIVISION OF INTRAMURAL RESEARCH WHICH IS OUR ON CAMPUS RESEARCH PROGRAM, AND IN 1991, HE CREATED THE NIDCD BOARD OF SCIENTIFIC COUNCILORS TO ADVISE THE DIRECTOR OF DIVISION OF INTRAMURAL RESEARCH. FOLLOWING HIS RETIREMENT, FROM THE NIDCD IN 1997, HE SERVED AS THE PRESIDENT OF THE PRESTIGIOUS INTERNATIONAL PRO SOCIETY AND PRESIDED AT HIS ANNUAL MEETING IN WASHINGTON D.C. IN 2000 AND SUBSEQUENTLY, Dr. SNOW FOUNDED THE TENNITIS RESEARCH CONSORTIUM AND AN AWARD WAS ESTABLISHED IN HIS HONOR. Dr. SNOW WAS A WORLD-CLASS DOCTOR WHO ENCOURAGED COLLABORATION AMONG SCIENTISTS OF THE FIELD AND HE WAS CHAIR OF THE DEPARTMENT AT THE UNIVERSITY OF PENNSYLVANIA. AS THE FIRST NIDCD DIRECTOR, HE CREATED SIGNIFICANT OPPORTUNITIES FOR SCIENTISTS AND TRAINEES ALIKE TO PERFORM AND HE WILL BE GREATLY MISSED BY ALL WHO KNEW HIM AND HAD THE PRIVILEGE OF WORKING WITH HIM. FROM 2017 INFORM 2019 AND SERVED ON THE NIDCD BOARD OF SCIENTIFIC COUNCILORS FROM 2009 TO 2014 AND HE WAS PROFESSOR IN THE DEPARTMENT OF FROM THE UNIVERSITY OF SOUTHERN CALIFORNIA AND HE ESTABLISHED A REPUTATION FOR HIS PIONEERING RESEARCH ON THE DEVELOPMENT AND REGENERATION OF HEARING THROUGH STUDIES OF THE INNER EAR. HIS INFLUENTIAL RESEARCH WAS FOUNDED ON INCITEFUL AND INNOVATIVE EXPERIMENTS AND AS WELL AS EASE IN EXTENDING HIS LABORATORY RYE SEARCH THROUGH COLLABORATIVE PARTNERSHIPS. HE WAS ENERGIZED BY AN ACTIVE IN HIS LABS RESEARCH AND THAT OF HIS COLLEAGUES TO THE TIME OF HIS PASSING. NEIL WILL BE GREATLY MISSED BY MANY. AND FORMER CONGRESSMAN JOHN EDWARD PORTER PASSED AWAY ON JUNE 3rd. HE SERVED ON THE U.S. HOUSE OF REPRESENTATIVES FROM 1980 UNTIL HIS RETIREMENT FROM CONGRESS I 2001. HE WAS CHAIR OF THE SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES, EDUCATION AND RELATED AGENCIES. THE COMMITTEE'S JURISDICTION COVERED ALL OF THE HEALTH PROGRAMS OF THE NIH AS WELL AS THOSE OF OTHER HEALTH RELATED FEDERAL AGENCIES. OVER THE PERIOD OF 1998, TO 2003, CONGRESS DOUBLED THE NIH BUDGET. Mr. PORTER WAS WIDELY RECOGNIZED AS THE LEAD ARCHITECT OF THAT REMARKABLE LEGISLATIVE ACHIEVEMENT. IN 2014, NIH DEDICATED THE JOHN EDWARD PORTER NEUROSCIENCE RESEARCH CENTER, A NEW TYPE OF RESEARCH FACILITY THAT WOULD UNITE INTRAMURAL NEUROSCIENCE RESEARCH ACROSS THE NIH. THE CENTER IS THE HOME FOR 85 RESEARCH GROUPS FROM 10 NIH INSTITUTES AND CENTERS INCLUDING MOST OF NIDCD'S INTRAMURAL LABORATORIES. NEXT SLIDE. JUST A LITTLE BIT OF AN UPDATE AFTER Dr. MIKE LAURE'S PRESENTATION. THE NIH IS IMPLEMENTING A NEW DATA MANAGEMENT AND SHARING POLL SHE AND IT WILL IMPACT NEARLY ALL NIH GRANT APPLICATIONS. THIS POLICY REINFORCES THE NIH'S LONGSTANDING COMMITMENT TO MAKING THE RESEARCH OF FUNDS AVAILABLE TO THE PUBLIC AND SETS THE BASELINE EXPECTATION THAT SHARING DATA IS A FUNDAMENTAL COMPONENT OF THE RESEARCH PROCESS. THIS POLICY WILL GO INTO EFFECT JANUARY 25th OF 2023. IN PREPARATION FOR THAT, THE NIH OFFICE OF SCIENCE POLICY AND THE OFFICE OF EXTRAMURAL RESEARCH IS HOSTING AN INFORMATIVE WEBINAR SERIES THAT IS FOCUSED ON THIS NEW POLICY. THE FIRST OF THE TWO WEBINARS TOOK PLACE IN AUGUST AND THAT WAS REPORTED AND WILL BE AVAILABLE FOR VIEWING. THEY DISCUSSED THE POLICY EXPECTATIONS AND THE APP LICK ABILITY OF THE POLICY AND HOW TO PREPARE A DATA MANAGEMENT AND SHARING PLAN AND CONSIDER INSURANCE FOR DATA SHARING RESPONSIBLY. THE SEPTEMBER WEBINAR, WHICH IS COMING UP SEPTEMBER 22nd, WILL EXPAND UPON THIS INFORMATION AND DIVE DEEPER INTO TOPICS INCLUDING PRIVACY PROTECTIONS FOR DATA FOR HUMAN PARTICIPANTS AND JUSTIFIABLE LIMITATIONS ON DATA SHARING. IN ANOTHER EFFORT, TO MAKE RESEARCH -- IN ANOTHER EFFORT TO MAKE RESEARCH RESULTS MORE ACCESSIBLE TO THE PUBLIC, THE WHITE HOUSE OFFICE OF SCIENCE AND TECHNOLOGY POLICY OR OSTP ISSUED ON AUGUST 25th AN UPDATED POLICY GUIDANCE DIRECTING FEDERAL AGENCIES TO EXPEDITE ACCESS TO RESULTS OF FEDERALLY FUNDED RESEARCH SO IT HAS TO DO WITH OPEN ACCESS AND AVAILABILITY OF PUBLISHED ARTICLES. NIH'S LONG CHAMPION PRINCIPLES OF TRANSPARENCY AND ACCESSIBILITY IN NIH FUND REED SEARCH AND SUPPORTS THIS IMPORTANT STEP. THE NIH WILL WORK TO DEVELOP AND SHARE ITS PLANS FOR IMPLEMENTING THE NEW OSTP POLICY GUIDANCE. AND NOW NEXT SLIDE, PLEASE. I WANT TO SHARE A NEW RESOLUTION THAT WAS PASSED BY THE AMERICAN MEDICAL ASSOCIATION THAT IS DEVELOP RANT TO THE NIDCD. THE AMERICAN MEDICAL ASSOCIATION OR THE AMA IS THE LARGEST AND ONLY NATIONAL ASSOCIATION IN THIS CONVENES 190 PLUS STAYED AND SPECIALTY MEDICAL SOCIETIES AND OTHER CRITICAL STAKEHOLDERS. ITS MISSION IS TO PROMOTE THE ART AND SCIENCE OF MEDICINE AND THE BETTERMENT OF PUBLIC-HEALTH. AT THIS SUMMER'S AMERICAN MEDICAL ASSOCIATION'S HOUSE OF DELEGATES MEETING THE MEMBERS ADOPTED RESOLUTION 113 PREVENTION OF HEARING LOSS ASSOCIATED COGNITIVE IMPAIRMENT THROUGH EARLIER RECOGNITION AND REMEDIATION. THE AMA'S RESOLUTION HIGHLIGHTS THESE THREE ACTION AREAS. FIRST, TO PROMOTE AWARENESS TO PHYSICIANS AND TO THE PUBLIC OF HEARING IMPAIRMENT AS A CONTRIBUTE OR TO THE DEVELOPMENT OF COGNITIVE IMPAIRMENT OR DEMENTIA IN LATER LIFE. SECOND, TO PROMOTE AND ENCOURAGE THE CONDUCT AND ACCELERATION OF RESEARCH INTO SPECIFIC PATTERNS AND DEGREES OF HEARING LOSS TO DETERMINE THOSE LINKED TO COGNITIVE IMPAIRMENT OR DEMENTIA AND THIRD TO WORK WITH INTERESTED NATIONAL MEDICAL SPECIALTY SOCIETIES AND STATE MEDICAL ASSOCIATIONS TO ENCOURAGE AND PROMOTE RESEARCH INTO HEARING LOSS AS A CONTRIBUTE OR TO COGNITIVE IMPAIRMENT AND INCREASE PATIENT ACCESS TO HEARING LOSS, IDENTIFICATION AND REMEDIATION SERVICES. SO, YOU MAY RECALL FROM A PREVIOUS MEETING THIS YEAR, Dr. RICHARD HODES SPOKE ABOUT THE CENTER BETWEEN THE NATIONAL INSTITUTE ON AGING AND THE NI CDC ON THE CONNECTION BETWEEN UNTREATED HEARING LOSS AND DEMENTIA SUCH AS ALZHEIMER'S. SO YOU CAN SEE THE AMA'S RESOLUTION FALSE DIRECTLY IN THESE MISSION AREAS AND ARE INSTITUTES ARE INTERESTED IN WORKING TOGETHER WITH THE AMA AS THEY IMPLEMENT THIS RESOLUTION. AND NOW, IN THE NEXT FEW SLIDES, WHICH WILL CONCLUDE MY PRESENTATION, I WANTED TO DISCUSS A LITTLE BIT ABOUT THE IMPACT OF HEARING LOSS AND TALK ABOUT AN IMPORTANT FDA REGULATION THAT WAS ISSUED LAST MONTH AND PROVIDE SOME BACKGROUND AND PERSPECTIVE ON THE SIGNIFICANT ROLE PLAYED BY THE NIDCD IN GETTING US TO THE POINT OF ISSUANCE OF THAT FDA REGULATION. SO, BY THE YEAR 2050, THE WORLD HEALTH ORGANIZATION ESTIMATES THAT MORE THAN 700 MILLION PEOPLE OR 1/10 PERSONS AROUND THE GLOBE WILL HAVE A DISABLING HEARING LOSS. IN THE U.S. ALONE WE KNOW THAT HEARING LOSS AFFECTS AN ESTIMATED 37 MILLION PEOPLE. HEARING LOSS CAN BE FRUSTRATING, ISOLATING, AND EVEN DANGEROUS. IT'S ALSO ASSOCIATED WITH DEMENTIA, DEPRESSION, ANXIETY, REDUCED MOBILITY, INCREASED RISK OF FALLS, HOSPITALIZATION AND HIGHER OVER ALL HEALTHCARE COSTS. ALTHOUGH HEARING TECHNOLOGY CAN BE TRANSFORMATIVE, NOT EVERYONE HAS EQUAL ACCESS TO THESE ADVANCEMENTS. IN FACT, ALTHOUGH HEARING AIDS AND OTHER ASSISTED DEVICES CAN SIGNIFICANTLY IMPROVE QUALITY OF LIFE, ONLY ONE IN FOUR U.S. ADULTS WHO COULD BENEFIT FROM HEARING AIDS HAS USED ONE. THE REASONS FOR THIS CAN BE VARIED, COST IS ALWAYS AND OFTEN CITED AS A MAJOR BARRIERS AND LIMITED ACCESS TO HEARING HEALTHCARE IS ANOTHER POTENTIAL BARRIERS. OTHER REASONS MAY INCLUDE THAT HEARING AIDS, THE BELIEVE THAT HEARING AIDS ARE NOT EFFECTIVE OR THAT THEY ASSOCIATE SOMEONE WITH A NEGATIVE CONNOTATION OF AGING OR OTHER STIGMAS. AND THE NEXT SLIDE. SO, I'M VERY PLEASED THAT ON AUGUST 16th, THE FOOD AND DRUG ADMINISTRATION ISSUED ITS FINAL ROLE FOR OVER THE COUNTER FOR OTC HEARING AIDS. THESE ARE INTENDED FOR USE BY ADULTS WITH PERCEIVED MILD TO MODERATE HEARING LOSS. THE NIDCD APPLAUDS THIS STEP. THE NEW REGULATION, AS SHOWN HERE, IS THE CULMINATION OF DECADES OF RESEARCH EFFORTS BY NIDCD AND OTHER SCIENTISTS EXPLORING KEY ISSUES FACED BY PEOPLE WITH HEARING LOSS. THE WRACKING GROUP ON ACCESSIBLE GROUP FOR ADULTS AND WITH MILD TO MODERATE HEARING LOSS CREATED A BLUE PRINT FOR RESEARCH PRIORITIES. THE BLUE PRINT LEAD TO NIDCD FUNDING OF MORE THAN 60 RESEARCH PROJECTS AND SPANNING THE LANDSCAPE OF ACCESSIBLE AND AFFORDABLE HEARING HEALTHCARE ISSUES. ONE STUDY SHOWED PEOPLE CAN INDEPENDENTLY ADJUST THE SETTINGS ON THEIR HEARING DEVICES CONTROLLING THEIR OWN HEARING AID SETTINGS THEY WERE SATISFIED WITH THE SOUND OF THE DEVICES THAN WITH THE AUDIOLOGIST. AND IN 2017, THE FIRST RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED CLINICAL TRIAL COMPARING AN OVER THE COUNTER DELIVERY MODEL OF HEARING AIDS, WITH TRADITION AT FITTING FOUND THAT BOTH PROVIDED SIMILAR BENEFITS. IN 2019, A FOLLOW-UP STUDY CONFIRM THESE RESULTS SUPPORTING THE VIABILITY OF A DIRECT-TO-CONSUMER SERVICE DELIVERY MODEL. AND A SMALL GRANT LED TO THE FIRST FDA APPROVED SELF-FITTING HEARING AID AND IN 2016, NIDCD CO-SPONSORS A CONSENSUS REPORT FROM THE NATIONAL ACADEMIES OF SCIENCES AND ENGINEERING AND MEDICINE OR ACCESS AND AFFORDABLE AND TO IMPROVE ACCESS TO HEARING AIDS FOR ADULTS WITH PER SIDE OF MILD TO MODERATE HEARING LOSS. I HAD THE HONOR OF SERVING ON THAT PANEL TO DEVELOP THE REPORT AND PRIOR TO COMING TO THE NIEHS. AT THE SAME TIME, THE PRESIDENT'S COUNCIL OF ADVISERS ON SCIENCE AND TECHNOLOGIES OR P CAST UNDER PRESIDENT OBAMA, DEVELOPED A REPORT AGING AMERICA LOSS AND HEARING TECHNOLOGIES AND THIS REPORT ALSO RECOMMENDED THAT THE FDA SHOULD APPROVE A CLASS OF HEARING AIDS FOR GRADUAL ONSET MILD TO MODERATE AGE-RELATED HEARING LOSS AND TO BE SOLD OVER THE COUNTER. SO, FOLLOWING THE PUBLICATION OF THE NATIONAL ACADEMIES AND THE REPORTS, SENATOR ELIZABETH WARREN'S STAFF CONTACTED NIDCD TO LEARN ABOUT THE RESEARCH IS THAT WE FUND THAT SUPPORTS THE DEVELOPMENT OF OTC HEARING AIDS. SO SOON AFTERWARDS, SENATORS WARREN AND CHECK GRASSILY INTRODUCED SENATE 670, THE OVER THE COUNTER HEARING AID ACT OF 2017. THE COMPANION BILL IN THE HOUSE, HR1652, WAS INTRODUCED BY HOUSE OF REPRESENTATIVES JOSEPH KENNEDY AND MARSHA BLACKBURN. THERE WAS BIPARTISAN SUPPORT FOR OTC HEARING AID LEGISLATION FROM BOTH CHAMBERS BUT IN THE 115th G AID BILL, WAS NOT GOING TO SEE MOVEMENT STANDING ON ITS OWN. SO CONGRESS ATTACHED THE BILL AS A PROVISION TO THE MUST-PASS FDA REAUTHORIZATION ACT HR 2430 AND PRESIDENT TRUMP SIGNED THE BILL INTO LAW ON AUGUST 18th, 2017. SO FIVE YEARS AGO. THE CONSISTENT RECOMMENDATIONS FROM BOTH THE NON GOVERNMENT AND GOVERNMENT AGENCIES COMBINED WITH NIDCD'S TARGETED RESEARCH PORTFOLIO PROVIDED A CRITICAL FOUNDATION FOR THIS MONUMENTAL REGULATION. AS A RESULT OF THESE RESEARCH AND POLICY EFFORTS, HEARING AIDS WITHIN THIS CATEGORY WILL BE SOLD DIRECTLY TO CONSUMERS IN STORES OR ON-LINE WITHOUT A MEDICAL EXAM AND WITHOUT A FITTING BY AN AUDIOLOGIST. THESE OTC HEARING AIDS WILL BE LESS EXPENSIVE AND EASIER TO OBTAIN POTENTIALLY IMPROVING THE HEALTH AND WELLBEING OF MILLIONS OF AMERICANS. THE OTC HEARING AID CATEGORY ESTABLISHED IN THIS FINAL ROLE, APPLIES TO CERTAIN HEARING AIDS INTENDED FOR PEOPLE 18 YEARS OF AGE AND OLDER, WHO HAVE PERCEIVED MILD TO MODERATE HEARING IMPAIRMENT. THERE'S NO REQUIREMENT FOR A HEARING TEST AND NO REQUIREMENT TO SEEK PROFESSIONAL SERVICES SUCH AS BY BEEN AUDIOLOGIST. HEARING AIDS THAT DON'T MEET THE REQUIREMENTS FOR THE OTC CATEGORY, FOR EXAMPLE, BECAUSE THEY'RE FOR SEVERE HEARING LOSS OR USED BY THOSE YOUNGER THAN AGE 18, WILL REMAIN AS PRESCRIPTION DEVICES. AS IS THE CASE FOR ALL FDA FINAL RULES, THE PROPOSED RULE WAS PUBLISHED IN OCTOBER OF 2021 AND THE FDA RECEIVED AND RESPONDED TO OVER 1,000 COMMENTS FROM THE PUBLIC. AND SOME OF THE FINAL REQUIREMENTS ARE LISTED IN THIS SLIDE. I WON'T GO THROUGH ALL OF THEM. THE EFFECTIVE DATE FOR THE FINAL ROLE IS OCTOBER 17th OF 2022. SO BY OPENING UP THE HEARING AID MARKET TO NONTRADITIONAL HEARING AID MANUFACTURERS WHICH COULD INCLUDE THE CONSUMER ELECTRONIC INDUSTRY OR TELE COM, WE BELIEVE THAT THESE NEW REGULATIONS, ALONG WITH CURRENT NIDCD RESEARCH EFFORTS, WILL CREATE AN ENVIRONMENT THAT SUPPORTS INNOVATION IN THE DEVELOPMENT OF EVEN MORE EFFECTIVE HEARING AIDS. AND MY LAST SLIDE, I THINK IS NEXT. SO, THANK YOU SO MUCH. IF ANYBODY HAS A QUESTION, PLEASE, SPEAK UP AND OTHERWISE WE'LL CONTINUE WITH THE REST OF THE PROGRAM. ANY QUESTIONS OR COMMENTS? ALL RIGHT. AND SO, NEXT, WE GO TO A DISCUSSION ABOUT THE INCLUDE PROGRAM WHICH IS A PROGRAM THAT THE NIDCD HAS A MAJOR PART IN AND I AM VERY PLEASED TO INTRODUCE OUR PROGRAM OFFICER Dr. KELLY KING, WHO REPRESENTS OUR EFFORTS WITH INCLUDE AND SHE WILL BEGIN AND ALSO INTRODUCE HER OTHER SPEAKERS. >> THANK YOU. MA LIS A. IAS Dr. TUCCI JUSTSAIA PROGRAM OFFICER HERE AT NIDCD. ONE OF THE FUN ROLES THAT PROGRAM STAFF TAKE ON AT THE INSTITUTE IS REPRESENTING OUR SCIENCE. WHEN VARIETY OF INITIATIVES AND ACTIVITIES THAT SPAN THE NIH. THE INSTITUTES, CENTERS AND OFFICES AND INITIATIVES THAT REALLY REACH OUR COLLECTIVE MISSION TO ENHANCE HEALTH, LENGTHEN LIFE AND REDUCE ILLNESS AND DISABILITY. ONE OF THOSE TRENDS NIH INITIATIVES IS THE INCLUDE PROJECT ON WHICH I'VE HAD THE PRIVILEGE OF WORKING SINCE IT WAS LAUNCHED IN 2018. THE FORMATION OF THE INCLUDE PROJECT WAS IN IMMEDIATE RESPONSE TO A CONGRESSIONAL DIRECTIVE. SO DOLLARS IN THE FEDERAL BUDGET WERE SET ASIDE SPECIFICALLY TO CREATE THIS NEW RESEARCH INITIATIVE ON THE CRITICAL HEALTH AND QUALITY OF LIFE NEEDS FOR INDIVIDUALS WITH DOWN SYNDROME. IT'S BEEN REISSUED EVERY YEAR SINCE AND IT'S BEEN REALLY REMARKABLE TO SEE WHAT'S BEEN ACCOMPLISHED IN JUST A FEW SHORT YEARS. SO, HERE TO TELL US MORE ABOUT THAT JOURNEY AND ALSO WHERE WE'RE HEADED IS OUR NEXT SPEAKER, Dr. MELISSA PARISI. SHE'S THE CHIEF OF THE INTELLECTUAL AND DEVELOPMENTAL DISABILITIES BRANCH AT THE EUNICE KENNEDY SHRIVER INSTITUTE OF HEALTH. SHE EARNED HER MD DEGREE AND ALSO A PH.D IN DEVELOPMENTAL BIOLOGY FROM STANFORD UNIVERSITY. FOLLOWED BY PEDIATRICS RESIDENCY AND MEDICAL GENETICS FELLOWSHIP AT THE UNIVERSITY OF WASHINGTON. PRIOR TO MOVING TO NIH, IN 2008, SHE WAS AN ASSISTANT PROFESSOR IN THE DEPARTMENT OF PEDIATRICS AT THE UNIVERSITY OF WASHINGTON AND SEE SEATTLE CHILDREN'S HOSPL WHERE SHE WAS A RESEARCHER IN THE BEHIND BRAIN MALL FORMATIONS SHE PROVIDES LEADERSHIP TO THE INTELLECTUAL DISABILITIES RESEARCH CENTERS PROGRAM AT NIDCD. THE DOWN SYNDROME PATIENT REGISTRY, WHICH IS KNOWN AS DS CONNECT, AND THE INCLUDE PROJECT, OTHERWISE KNOWN AS INVESTIGATION OF CO OCCURRING TO UNDERSTAND DOWN SYNDROME. THANK YOU FOR JOINING US TODAY AND YOUR LEADERSHIP WITH INCLUDE. I WILL HAND IT OFF TO YOU. >> THANK YOU, VERY MUCH FOR THAT INTRODUCTION, KELLY AND I JUST WANT TO MAKE SURE THAT MY SLIDES ARE SHOWING IN THE WAY THAT THEY SHOULD BE FOR A PRESENTATION MODE. IS THAT CORRECT? >> THEY LOOK GREAT. >> THANK YOU SO MUCH. WELL, IT'S REALLY A PLEASURE FOR ME TO PARTICIPATE WITH YOU ALL TODAY AND TELL YOU A LITTLE BIT ABOUT THE INCLUDE PROJECT AND SOME OF THE RESEARCH WE'VE BEEN ABLE TO ACCOMPLISH THROUGH A TRANS NIH INITIATIVE ACROSS MANY INSTITUTES HERE AT NIH. SO, I THINK MANY OF YOU KNOW ABOUT DOWN SYNDROME BUT I JUST WANTED REMIND EVERYONE THAT THIS IS THE MOST COMMON CHROMOSOMAL DISORDER, THE MOST COMMON GENETIC CAUSE OF INTELLECTUAL DISABILITY AND OCCURS IN 1/770 NEWBORN. FOR ABOUT 95% OF THOSE WITH DOWN SYNDROME THEY HAVE THREE FULL COP KEYS OF CHROMOSOME 21 AND 5% HAVE A TRANSLOCATION, A PARTIAL TRYSOMI FOR MOSAIC FOR 21. THE FOCUS OF THE INCLUDE INITIATIVE IS THE CO OCCURRING CONDITIONS THAT OCCUR IN DOWN SYNDROME. ALMOST ALL OF THE INDIVIDUALS HAVE MILD TO MODERATE INTELLECTUAL DISABILITY, SLEEP APNEA IS EXTREMELY COMMON AND YOU WILL HEAR ABOUT A SPECIFIC APPLICATION TO TREAT SLEEP APNEA AFTER MY COMMENTS. HEARING LOSS IS ALSO VERY COMMON IN DOWN SYNDROME, WITH ESTIMATES THAT BETWEEN 50 AND 75% OF CHILDREN EXPERIENCE HEARING LOSS AND WHILE ONLY ABOUT 5% OF THAT HAVE IS SENSORY NEURAL, A LOT OF HEARING LOSS IS ASSOCIATED WITH OTITIS MEDIA WITH INFLATION AND DUE TO THE ALTERATIONS OF THE IN THE A M ANATOMY WITH THE EAR STRUCTURE. THIS IS A PROBLEM FOR CHILDREN AND ADULTS WITH DOWN SIN DOM. AUTOIMMUNE PROBLEMS ARE COMMON IN DOWN SYNDROME AND HEART DEFECTS IMPACT ABO 50% AND INCRE RISK OF EARLY ALZHEIMER'S DISEASE. I THINK THAT THIS AUDIENCE WOULD OF COURSE CONQU CONCUR WITH THEN THAT RESEARCH HAS A POSITIVE IMPACT ON LIFESPAN OF INDIVIDUALS WITH CONDITIONS AND THAT APPLIES TO DOWN SYNDROME AS WELL. IF YOU LOOK AT THE LEFT GRAPH, IN THE 1970s, THE MOST COMMON CAUSE OF DEATH WAS BASICALLY CONGENITAL HEART DEFECTS BUT CAN SURGICAL CARE IN THE '70s IT'S A MUCH LOWER CAUSE OF DEATH WITH DEMENTIA INCREASING NOW THE MOST COMMON CAUSE OF DEATH IN THE YEAR 2020. THE LIFE EXPECTANCY HAS INCREASED FROM NINE-YEARS-OLD IN 1959 TO NOW ABOUT 60 YEARS OF AGE AND THIS GRAPH ON THE RIGHT, YOU CAN SEE THAT THE NUMBERS OF INDIVIDUALS THAT ARE IN THE HIGHER AGE RANGES, HAS CONTINUED TO INCREASE SINCE 1950s. SO THIS IS ALL GOOD NEWS. BUT THAT MEANS THAT THERE ARE PEOPLE WITH DOWN SYNDROME WHO ARE LIVING WITH THESE CONDITIONS AND WE WANT TO IMPROVE THEIR QUALITY OF LIFE AND THAT'S THE GENESIS FOR THE INCLUDE PROJECT. SO, THIS INITIATIVE WAS LAUNCHED IN 2018 UNDER A CONGRESSIONAL DIRECTION TIVE THAT STEMMED OUT OF A SPECIAL HEARING THAT WAS HELD IN FRONT OF THE HOUSE APPROPRIATIONS SUBCOMMITTEE. A GENTLEMAN WITH DOWN SYNDROME, FRANK STEVENS, GAVE A VERY COMPELLING TESTIMONY TALKING ABOUT HOW HE PERSONALLY WAS IMPACTED BY HAVING DOWN SYNDROME AND VERY CONCERNED ABOUT HIS HEALTH, HIS FUTURE HEALTH NEEDS AND THAT OF HIS MOTHER WHO ALSO SUFFERED FROM ALZHEIMER'S DISEASE. SO, ON THE BASIS OF THAT TESTIMONY, AND A NUMBER OF OTHER CONSIDERATIONS, CONGRESS BASICALLY TOLD US AT NIH THAT WE NEEDED TO ADDRESS THE CRITICAL HEALTH AND QUALITY OF LIFE NEEDS WITH PEOPLE WITH DOWN SYNDROME. ESPECIALLY ADDRESSING THOSE IMPACTS THAT ARE ALSO FELT IN THE GENERAL POPULATION. AND THESE INCLUDE ALZHEIMER'S, AUTISM, CAT A RACK, DIABETES AND MANY OTHER CONDITIONS THAT OCCUR IN THE GENERAL POPULATION AS WELL AS IN THE DOWN SYNDROME POPULATION. WE WERE REALLY GIVEN THE TASK OF MAKING THIS A TRANS NIH INITIATIVE AND WE WANTED IT TO BE TRANSFORMATIVE FOR PEOPLE WITH DOWN SYNDROME AND INCREASE THE NUMBER OF INVESTIGATORS WORKING IN THE SPACE AND IN DOING SO, WE RECOGNIZED THAT WE NEEDED TO ENGAGE WITH THOSE WITH DOWN SYNDROME AND THEIR FAMILY AND COMMUNITIES. SO, OBVIOUSLY YOU ALL KNOW THAT WE LIKE ACRONYMS AT NIH AND SO ENCLOUD HAS ITS OWN AND INVESTIGATION OF CO-OCCURRING CONDITIONS ACROSS THE LIFESPAN TO UNDERSTAND DOWN SYNDROME AND OF COURSE, THAT ACRONYM HAS DOUBLE MEANING TOO BECAUSE IN THE PAST, MANY PEOPLE WITH DOWN SYNDROME HAVE BEEN EXCLUDED FROM PARTICIPATING IN RESEARCH DUE TO CONCERNS ABOUT ABILITY TO PROVIDE AND INFORM CONSENT, SOMEWHAT PATERNALISTIC VIEW OF PROTECTING THEM FROM RESEARCH BUT WE'RE HOPING THAT THIS INITIATIVE WILL TRANSFORM THAT UNDERSTANDING AND INCREASE ACCESSIBILITY OF RESEARCH FOR PEOPLE WITH DOWN SYNDROME. THERE ARE THREE COMPONENTS TO THE INCLUDE INITIATIVE, THE FIRST IS FOCUSING ON HIGH-RISK, HIGH REWARD BASIC SCIENCE STUDIES TRYING TO UNDERSTAND THE BIOLOGY OF DOWN SYNDROME INDICATED HERE IN THE LIGHT PURPLE. THE SECOND COMPONENT IS BUILDING A LARGE COHORT OF INDIVIDUALS WITH DOWN SYNDROME ACROSS THE LIFESPAN FOR COMPREHENSIVE BIOMARKER EVALUATION AND THAT IS INDICATED HERE IN THE PINK AND FINALLY, THE THIRD COMPONENT IS TO INCLUDE PEOPLE WITH DOWN SYNDROME AND EXISTING AND FUTURE CLINICAL TRIALS AND INDICATED HERE IN THE LIGHT GREEN. AND THIS IS SOME OF THE MECHANISMS THAT WE'VE USED TO TRY TO JUMP START RESEARCH IN THESE THREE DOMAINS. WE'RE VERY PLEASED THAT THE TOTAL AMOUNT OF FUNDING FOR DOWN SYNDROME RESEARCH HAS INCREASED AS A CONSEQUENCE OF THE INCLUDE INITIATIVE AND IF YOU LOOK AT THE FUNDING THAT WE HAD ACROSS NIH AND THE EARLY 2010s, WE WERE AROUND 20 TO $30 MILLION PER YEAR FOR DOWN SYNDROME THAT'S INDICATED IN THIS LIGHT BLUE BAND. BUT STARTING IN 2018, WITH THE INCLUDE INITIATIVE, WE'VE BEEN ABLE TO INCREASE FUNDING SPECIFICALLY FOR DOWN SYNDROME, SUCH IN FY21 WE HAD $109 MILLION DEDICATED FOR DOWN SYNDROME RESEARCH AND 65 FROM THE DARK BLUE BAND CAME FROM INCLUDE AWARDS. WE'RE ON TRACK TO $75 MILLION AND INCLUDE FUNDING FOR THIS FISCAL YEAR '22. IF YOU LOOK AT A BREAKDOWN OF THOSE AWARDS AND HOW THEY'RE DISTRIBUTED ACROSS THE NIH, THAT 2021 FUNDING OF $65 MILLION IS DISTRIBUTED IN 53 NEW AWARDS, A COUPLE OF IT ARE AT NIDCD ASSIGNED FOR $1.24 MILLION AND WE HAVE OBLIGATIONS PRIOR APPLICATIONS AND SOME PROGRAMS SUPPORT BUT WE'RE REALLY TRYING TO CONTINUE TO INCREASE THE DISTRIBUTION OF INCLUDE FUNDING SO THAT WE CAN ENGAGE ALL OF THE INSTITUTES AND CENTERS ACROSS NIH WITH AN INVESTMENT AND AN CENTER INTEREST IN SUPPORTING DOWN SYNDROME RELATED RESEARCH. WE'VE DONE THIS THROUGH FUNDING OPPORTUNITIES. THE PAST FISCAL YEAR WE'VE BEEN QUITE BUSY TRYING TO REISSUE IN OF THOSE INITIAL RFAs AND FUNDING OPPORTUNITIES THAT WE FIRST PUBLISHED IN 2019, AND A COUPLE OF THOSE REALLY SPEAK TO SOME OF THE PRIORITIES AND THE COMPONENTS OF THE PROJECT. SO, FOR THE BASIC SCIENCE AREA, WE'VE FOCUSED ON TRANSFORMATIVE RO1s LOOKING AT BASIC SCIENCE TYPES OF RESEARCH. WE'VE TRIED TO DEVELOP SOME OF OUR COHORTS BY LOOKING AT DATA ANALYSIS AND SECONDARY DATA ANALYSIS PROJECTS THROUGH THE RO3 MECHANISM AND WE HAVE A COUPLE OF RFAs THAT ARE FOCUSED ON CLINICAL TRIALS, ONE THAT IS TRYING TO SET THE STAGE FOR FUTURE CLINICAL TRIALS AND THEN ALSO, PHASED CLINICAL TRIAL AWARDS KNOWN AS R61 AND R33 AND WE'RE PLEASED WE'VE ACTUALLY BEEN ABLE TO FUND EIGHT CLINICAL TRIALS FOR IN CONCLUDE IN THE PAST SEVERAL YEARS. WE'VE ALSO RECENTLY ISSUED A NUMBER OF ADDITIONAL FUNDING OPPORTUNITIES TO ENCOURAGE TRAINEES IN THIS SPACE. SO WE HAVE A PARTICULAR NOTICE SPECIFICALLY FOR FELLOWSHIP TRAINEES AND F AWARDS AND CAREER DEVELOPMENT AWARDS OR K AWARDS AND THOSE FOR INSTITUTIONS THAT HAVE NOT HAD A SUBSTANTIAL NIH INVESTMENT KNOWN AS THE AREA AND REAP AWARDS OR THE R15s, AND THEN WE HAVE SOME SPECIFIC TRAINING AWARDS THAT ARE LINKED TO THE CTSA PROGRAM, THE CLINICAL TRANSLATIONAL SCIENCE AWARDS THAT ARE LED BY NOT CAT, WE HAVE A HOST OF ADDITIONAL NOTICES AVAILABLE THAT ARE AVAILABLE ON OUR WEBSITE. SO, WHAT HAVE WE BEEN ABLE TO DO? IT'S ONLY BEEN ABOUT FIVE YEARS AND IT FEELS LIKE THERE'S A LOT THAT'S GONE ON AND AS ALL OF YOU KNOW IT TAKES A WHILE FOR THERE TO BE RESULT THAT'S COME OUT OF THE RESEARCH THAT WE'RE FUNDING. SO, IN OUR PAST FOUR YEARS OF INVESTMENT, IN OUR 200 NEW PROJECTS, AND $183 MILLION, I'VE COLOR COATED TO MATCH OUR THREE COMPONENTS SOME VERY BRIEF HIGHLIGHTS OF SOME OF WHAT WE'VE BEEN ABLE TO FUND. SO WE'RE DOING BASIC SCIENCE WORK LOOKING AT RAT MODELS OF DOWN SYNDROME, APPROACHES TO SILENCE THE EXTRA CHROMOSOME 21 IN CELL LINES. LOOKING AT IMPACT OF COVID-19 ON THE IMMUNE SYSTEM OF INDIVIDUALS WITH DOWN SYNDROME. WE'VE BEEN FUNDING CLINICAL STUDIES LOOKING AT EYE GLASS PRESCRIPTIONS AND HOW TO OPTIMIZE THOSE. TRYING TO DEVELOP COGNITIVE MEASURES THAT ARE PART OF THE NIH TOOLBOX THAT ARE SPECIFIC FOR CHILDREN WITH DOWN SYNDROME. AND SOME STUDY YOU WILL HEAR ABOUT FROM KELLY KING LOOKING AT LANGUAGE ACQUISITION AND ARTICULATION IN CHILDREN WITH DOWN SYNDROME THAT CAN BE AN IMBEDMENT THEY BE UNDERSTOOD BY OTHER INDIVIDUALS. IN THE CLINICAL TRIALS SPACE, WE'RE LOOKING AT WHETHER HOME SLEEP STUDIES MIGHT BE RELIABLE FOR A HOSPITAL-BASED APPROACH, MIGHT BE MORE RELIABLE THAN HOSPITAL BASED SLEEP STUDIES TO HELP UNDERSTAND SLEEP APNEA AND INTERVENTIONS TO IMPROVE COMPLIANCE WITH SLEEP APNEA SYSTEMS AND YOU WILL HEAR FROM Dr. SKOTKO ABOUT THE NERVE STIMULATION USED FOR SLEEP APNEA IN DOWN SYNDROME. AND COHORTS OF ADULTS WITH DOWN SYNDROME FOR NEURO DEGENERATION THAT WILL HELP PREDICT WHICH INDIVIDUALS ARE LIKELY TO DEVELOP ALZHEIMER'S DISEASE IN THE NEAR FUTURE. IN FACT, PIVOTING TO TALK ABOUT ALZHEIMER'S DISEASE IN DOWN SYNDROME. BY VIRTUAL OF THE FACT THAT THE AMYLOID PRECURSOR PROTEIN IS FOUND. EVERY PERSON BORN WITH DOWN SYNDROME HAS THREE COPIES OF THIS GENE AND IT PUTS THEM INCREASE DEVELOPING ALZHEIMER'S AND BETA AMYLOID IS A TRIGGER AND A FIRST STAGE IN DEVELOPING DEMENTIA SO UNFORTUNATELY, MANY ADULTS START TO SHOW SYMPTOMS OF AD IN THEIR 50s AND 60s SO WE HAVE THE BIOMARKER CONSORTIUM OF DOWN SYNDROME AND IT'S LONGITUDINAL STUDY IN ITS SEVENTH YEAR. WE'RE STUDYING OVER 400 ADULTS WITH DOWN SYNDROME FROM 25 YEARS OF AGE AND ON AND LOOKING AT A VARIETY OF DIFFERENT COGNITIVE GENETIC BLOOD BASED BRAIN SCAN IMAGING BIOMARKERS TO HELP US UNDERSTAND THE EVOLUTION OF DEMENTIA IN THIS POPULATION AND AS A CONSEQUENCE WE'RE ALSO LOOKING AT LIFESTYLE RISK AND RESILIENCY FACTOR, DIET AND EXERCISE, DO THOSE MODIFY IT IN THE POPULATION AND WE'RE JUST INFORM FEW STARTING A CLINICAL TRIAL TO TEST A PREVENTATIVE MEDICATION FOR ADULT THIS IS DOWN SYNDROME AND A STUDY THAT'S IN ITS EARLY STAGES LOOKING AT GMCSF TO IMPROVE COGNITION IN ADULTS WITH DOWN SYNDROME SO THIS INITIAL PROJECT IS REALLY SPURRED A LOT OF ADDITIONAL STUDIES LOOKING AT DA ME SHA INE DOWN SYNDROME POPULATION. ONE OF THE IMPORTANT COMPONENTS OF INCLUDE IS THE COHORT DEVELOPMENT. THEY INCLUDE DATA COORDINATING CENTER WAS FUNDED TWO YEARS AGO TO START UNDERSTANDING THESE LARGE COHORTS AND PUT TOGETHER THE DATA IN A WAY THAT WOULD MAKE IT ACCESSIBLE TO A LARGE GROUP OF INDIVIDUALS. THE DATA COORDINATING CENTER HAS THREE SEPARATE UNITS, A DATA PORTAL, WHICH WAS JUST LAUNCHED RECENTLY, AND THE DATA MANAGEMENT CORE WHICH IS WORKING BEHIND THE SCENES TO AGGREGATE DATA FROM A VARIETY OF DIFFERENT STUDIES AND PUT THAT IN A FORMAT THAT IT CAN BE PRESENT TODAY A WIDER AUDIENCE AND THE ADMINISTRATIVE AND OUTREACH CORE WORKING WITH THE PUBLIC AND WITH INVESTIGATORS TO HELP MAKE THE DATA ACCESSIBLE TO THEM. SO, THE INCLUDE DATA HUB WAS JUST LAUNCHED ON WORLD DOWN SYNDROME DAY WHICH WAS MARCH 21st OR 3-21-22 AND THIS SUB HAS OVER 6,000 CLINICAL INDIVIDUALS PARTICIPATING THROUGH A VARIETY OF DIFFERENT STUDIES THAT ARE COLLATED UNDER THE DATA HUB. THERE ARE 2,500 GENOME SEQUENCE AND 400 PLUS TARGETED METABOLOMICS PART OF THE STUDIES AND IT'S PRESENTED IN A WAY THAT'S EASY TO DIGEST AND ACCESSIBLE TO THE PUBLIC OR INVESTIGATORS AND CURRENTLY, NOW, TRYING TO INCREASE ITS REACH BY INCORPORATING ADDITIONAL INCLUDE AND OTHER FUNDED STUDIES AS PART OF THE DATA ACQUISITION. SO, SOME OF THE STUDIES THAT I'VE TOLD YOU ABOUT, ABCDS AND I'M ABOUT TO TELL YOU ABOUT DOWN SYNDROME REGISTRY HAVE THEIR DATA AS PART OF THE DATA COORDINATING CENTER DATA HUB AND UTILIZING A PLATFORM THAT IS IT FOCUSED ON DATA SHARING WE THINK WILL HELP INQUIRIES INTO THESE DATASETS THAT WILL LEAD TO STUDIES THAT WILL IMPROVE QUALITY OF LIFE FOR PEOPLE WITH DOWN SYNDROME. I WANT TO TELL YOU ABOUT DS-CONNECT THE DOWN SYNDROME REGISTRY WHICH IS A IMPORTANT PART OF OUR CONNECT TO THE DOWN SYNDROME RESOURCE THAT WILL HELP INCREASE THE COHORT AND LEAD TO IMPROVEMENTS AND RECRUITMENT FOR CLINICAL TRIALS. DS CONNECT IS A SECURE AND ON-LINE REGISTRY THAT WAS CREATED BY NIDCD BACK IN 2013 TO HELP FACILITATE RESEARCH PARTICIPATION IN DOWN SYNDROME CLINICAL STUDIES. AND IT HAS A SPANISH LANGUAGE AVAILABLE WEBSITE AS WELL AND THERE ARE OVER 5500 CURRENTLY REGISTERED PARTICIPANTS IN THIS REGISTRY AND FAMILIES UP LOADS SOME BASIC DEMOGRAPHIC AND HEALTH INFORMATION ABOUT THEIR LOVED ONE WITH DOWN SYNDROME AND THEY'RE GIVEN SPECIFIC INVITATIONS TO PARTICIPATE IN RESEARCH PROJECTS THAT THEY HAVE EXPRESSED AN INTEREST IN AND WE NEVER SHARE THEIR PRIVATE HEALTH INFORMATION WITH INVESTIGATORS WE SERVE AS THE TRUSTED LIAISON BETWEEN THE PARTICIPANTS AND THE INVESTIGATORS WHO ARE INTERESTED IN RECRUITING FOR THEIR STUDIES. AND WE USE THE PROFESSIONAL PORTAL AS A WAY TO INVITE INVESTIGATORS TO SIGN UP FOR AND REQUEST AID WITH THEIR RECRUITMENT FOR THEIR STUDIES AS PART OF DS-CONNECT. IN THE PAST SEVEN YEARS OVER 90 STUDIES HAVE REQUESTED RECRUITMENT SUPPORT AND 90% OF THOSE HAVE BEEN APPROVED BY OUR RESEARCH RECREW COMMITTEE WHICH IS COMPOSED OF PARENTS, FAMILY MEMBERS, RESEARCHERS AND OTHERS WITHIN INTEREST IN DOWN SYNDROME RESEARCH AND OVER 12 INCLUDE PROJECTS HAVE RECEIVED RECRUITMENT SUPPORTING INCLUDING FIVE OF OUR CLINICAL TRIALS AND SO WE HAVE OVER 500 RINGS PROFESSIONALS WHO ARE PART OF DS SHOULD HAVE CONNECT WHO UTILIZE THE RESOURCES AND THE DEIDENTIFIED DATA TO HELP WITH THEIR RECRUITMENT EFFORTS. SO I FINALLY WANT TO JUST CLOSE BY TELLING YOU A LITTLE BIT ABOUT SOME OF OUR COMMUNITY ENGAGEMENT AND OUTREACH EFFORTS. AND I THINK MANY PEOPLE KNOW THAT RESEARCH IN THE PAST UTILIZING OR BASED ON STUDIES OF INDIVIDUALS WITH INTELLECTUAL DISABILITIES, HAVE OFTEN BEEN FRAUGHT WITH ETHICAL CONCERNS AND THERE'S BEEN A HESITATION ON THE PART OF THE DOWN SYNDROME AND THE COMMUNITY OF INDIVIDUALS WITH INTELLECTUAL DISABILITIES TO PARTICIPATE IN RESEARCH. SO WE RECOGNIZE THAT WE REALLY NEED TO DO OUR JOB TO REACH OUT TO THE COMMUNITY AND MAKE THEM FEEL WELCOME TO PARTICIPATE. SO, WE HAVE BEEN ENGAGING IN ADVOCACY GROUP, COMMUNITY OUTREACH AND A VARIETY OF DIFFERENT MECHANISMS TO INCREASE THE AVAILABILITY OF THESE RESOURCES AND WE HAVE AN ELECTRONIC TOOLKIT AVAILABLE WITH INFO CARDS, FLYERS AND SOCIAL MEDIA MESSAGES AND WE HAVE THIS FLY ERR ON THE RIGHT THAT WE JUST PUBLISHED RECENTLY FOR THE INCLUDE PROJECT OVER ALL AND OUR GOAL IS TO REALLY RECRUIT 10,000 PARTICIPANTS BY THE 10-YEAR ANNIVERSARY OF THAT INITIATIVE. WE'RE SUPPORTING A DIVERSITY WORKSHOP THAT WILL BE HOST INSIDE TWO WEEKS. THIS IS AVAILABLE TO THE COMMUNITYCOMMUNITY. WE WANT TO ENGAGE THE DOWN SYNDROME COMMUNITY TO ENHANCE DIVERSITY WITHIN OUR STUDY COHORTS AND AMONG OUR INVESTIGATORS AND TRAINEES BECAUSE WE RECOGNIZE THAT WE'VE HAD A DIVERSITY ISSUE WITH REGARD TO OUR FUNDED STUD SKIS THAT THEY HAVE TYPICALLY HAD PARTICIPANTS WHO ARE WHITE AND HAVE HIGHER SOCIOECONOMIC STATUS CLASSES. WE HOSTED TWO LISTENING SESSIONS WITH FAMILIES AND WITH RESEARCHERS AND WE THINK THIS IS A GREAT VENUE TO UNDERSTAND MORE ABOUT SOME OF THE ISSUES FOR FAMILIES TO PARTICIPATE IN RESEARCH AND WAYS IN WHICH WE CAN IMPROVE THAT DIVERSITY. AND THEN FINALLY, WE HAVE A FEW OTHER DIVERSITY ACTIVITIES. WE HOSTED A DATA SCIENCE FOR DIVERSE SCHOLARS IN DOWN SYNDROME. A TWO-WEEK SUMMER COURSE SPONSORED BY THE DCC IN COLORADO WHICH WAS A NICE VENUE. WE ARE STARTING TO HOST A CLINICAL TRIALS WEBINAR SERIES ON STARTING WITH OUR FIRST PRESENTATION ON ASSENT AND CONSENT ISSUES AND WE HAVE A COUPLE OF FUNDING OPPORTUNITIES THAT ARE DESIGNED TO ENCOURAGE DIVERSITY AND SO WE'RE TRYING TO PROMOTE M HEALTH ACTIVITIES THAT WOULD MAKE SOME OF OUR OUTREACH MORE BROADLY AVAILABLE TO THE DOWN SYNDROME COMMUNITY WHERE THEY LIVE WHETHER THEY'RE IN RURAL OR MORE METROPOLITAN AREAS AND WORE TRYING TO PROMOTE COMMUNITY-BASED PAR PISS TORI RESEARCH TO HELP WITH DISPARITIES AND TO ENCOURAGE DIVERSE RECRUITMENT IN ALL OF OUR FOAs WHICH IS AN UNDERLYING THEME OF THE FUNDING OPPORTUNITIES THAT WE'VE BEEN PUBLISHING IN THE PAST YEAR TO YEAR-AND-A-HALF. WE'RE LOOKING FORWARD TO HAVING MORE DIVERSITY IN OUR POPULATION BEING STUDIED. AND SO, FINALLY, OUR GUIDING PRINCIPLES WHICH I THINK MOST OF WOULD YOU SAY AGREE WITH FOR MOST OF OUR RESEARCH ENDEAVORS, WE WANT TO CONTINUE TO RESPECT THE RIGHTS OF PERSONS WITH DOWN SYNDROME AND WE USE PEOPLE-FIRST LANGUAGE WHEN POSSIBLE AND WE BELIEVE IN BROAD AND RAPID DATA SHARING. WE WANT TO INCREASE DIVERSITY OF NOT ONLY PARTICIPANTS BUT ALSO THE RESEARCHERS WHO ARE ENGAGE IN THAT RESEARCH AND WE BELIEVE THAT RESEARCH THAT OUTREACH TO FAMILIES IS ABSOLUTELY ESSENTIAL AND WE CONTINUE TO PARTNER WITH OUR ADVOCACY GROUPS AND MANY OF THOSE GROUPS ARE PART OF THE DOWN SYNDROME CONSORTIUM THAT PROVIDES GUIDANCE TO US NOT ONLY FOR OUR DOWN SYNDROME RELATED ACTIVITIES AT NIH AND ALSO BROADLY TO THE INCLUDE PROJECTS SO I JUST WANT TO CLOSE WITH A THANK YOU TO YOU ALL FOR YOUR INTEREST IN PARTICIPATION AND A SPECIAL THANK YOU TO THE NIDCD PROGRAM STAFF WHO HAVE BEEN INVOLVED IN INCLUDE AND PARTICULARLY KELLY KING, AS WELL AS LANA AND Dr. JUDITH COOPER WHO IS ALSO BEEN INVOLVED IN SOME OF THESE AWARDS AND FINALLY ALL TO HAVE YOU HAVE BEEN VERY HELPFUL AND WONDERFUL COLLEAGUES IN PARTICIPANTS AS WE TROY TO ACCOMPLISH OUR GOALS FOR IN CONCLUDE. THANK YOU. >> Dr. Debara Tucci: THANK YOU SO MUCH, MELISSA, I DON'T THINK IT CAN BE UNDER SCORED ENOUGH HOW MUCH BEEN ACCOMPLISHED IN THE SHORT PERIOD OF TIME AND THE BEHIND OF SCENES WORK THAT GOES INTO THIS IS REALLY IMPRESSIVE AND IT'S A GREAT TEAM TO WORK WITH AND I LEARN SOMETHING NEW ALL THE TIME. I'M GOING TO GO AHEAD AND SHARE MY SCREEN QUICKLY BECAUSE BEFORE I INTRODUCE OUR NEXT SPEAKER, I WANT TO HIGHLIGHT JUST SOME OF THE WAYS THAT NIDCD SCIENCE MISSION AREAS HAVE BENEFITED FROM PARTNERING WITH INCLUDE. IT'S BEEN GREAT TO SEE THAT THE COMMUNITIES THAT WE SERVE AND OUR SCIENCE HAVE BEEN ABLE TO ENGAGE WITH THIS INFUSION OF SUPPORT TOWARDS RESEARCH WITH DOWN SYNDROME. WE STARTED OUT IN 2018, WHICH AS YOU HEARD WAS THE FIRST YEAR OF INCLUDE WITH THREE ADMINISTRATIVE SUPPLEMENTS TO PIs WORKING IN OUR MISSION AREAS AND THESE WERE DESIGNED TO TAKE ON GOING WORK THAT WASN'T FOCUSED ON DOWN SYNDROME AND EXPAND IT INTO DOWN SYNDROME POPULATIONS AND AT LEAST ONE OF THESE SUPPOSEMENTS WAS LEVERAGED INTO A FOLLOW-UP RO1 FROM LORI LIEBOLD LOOKING AT SPEECH PERCEPTION AND AUDITORY IN INFANTS, CHILDREN AND ADULTS WITH DOWN SYNDROME AND STEPHEN ADD VANTER SET HAS A LIFELONG STRONG PASSION FOR SEARCHING PEOPLE WITH DOWN SYNDROME AND THEIR FAMILIES AND HE LOOKED AT ARTICULATION ACCURACY AND SPEECH INTEL EDGE ABILITY AND YOU HEARD MELISSA ACKNOWLEDGE, COMMUNICATION AND THE ABILITY TO BE UNDERSTOOD WHEN YOU ARE EXPRESSING YOURSELF, THESE ARE SUCH SIGNIFICANT FOR INDIVIDUALS WITH DOWN SYNDROME AND THEIR FAMILIES. RUTH LATOFSKY KNOW FROM WORK IN COCHLEAR IMPLANTS RECENTLY EXPANDED HER SCIENCE AND EFFORTS TOWARDS WORKING WITH INDIVIDUALS WITH DOWN SYNDROME AND SHE HAS BEEN ABLE TO LEVERAGE SOME REALLY UNIQUE COLLABORATIONS WITH COLLEAGUES AT THE WISEMAN CENTER AT THE UNIVERSITY OF WISCONSIN, MADISON WHERE THERE'S AN ESTABLISHED COHORT OF PATIENTS AND PARTICIPANTS WITH DOWN SYNDROME ENGAGE IN RESEARCH AND THIS TEAM IS LOOKING AT AUDITORY FUNCTION COGNITION LANGUAGE AND BRAIN STRUCTURE IN DOWN SYNDROME. HEATH PORTER, DID HER DOCTORAL WORK MANY YEARS AGO LOOKING AT HEARING IN CHILDREN WITH DOWN SYNDROME AND IS NOW LEVERAGING RAILROAD HITCH EXPERIENCE AS A CLINICIAN SCIENTIST BY CONTINUING IN THIS AREA WITH AIM AROUND ADVANCING CLINICAL PRACTICE AND ESTABLISHING FOUNDATIONAL THEORY FOR AUDITORY FUNCTION AND INDIVIDUALS WITH DOWN SYNDROME. AND FINALLY A PROJECT THAT WE'LL LEARN MORE ABOUT TODAY, IS A CLINICAL TRIAL AND ON GOING CLINICAL TRIAL WITH THE EFFECTS OF HYPO GLOSSAL NERVE STIMULATION ON COGNITION AND LANGUAGE AND DOWN SYNDROME. IT'S LED BY THE MULTI P.I. TEAM OF Dr. CHRIS HARTNICK AND BRIAN SKOTKO THIS IS A U01 AWARD WHICH MEANS A CO-OPERATIVE AGREEMENT BETWEEN NIDCD AND THE AWARDEE INSTITUTIONS AND WE USE THIS MECHANISM TO SUPPORT OUR INVOLVED CLINICAL TRIALS AND I'M PLEASED AND ABOARD MEDICAL GENETICIST AND MASSACHUSETTS GENERAL HOSPITAL AND AS THE DIRECTOR OF HOSPITAL'S DOWN SYNDROME PROGRAM, HE DEDICATED HIS PROFESSIONAL ENERGY TOWARDS CHILDREN WITH COGNITIVE AND DEVELOPMENTAL DISABILITIES. HE CO-AUTHORED THE NATIONAL AWARD-WINNING BOOKS, COMMON THREADS, CELEBRATING LIFE WITH DOWN SYNDROME AND FASTEN YOUR SEATBELT, A CRASH COURSE ON. HE IS A GRADUATE OF DUKE UNIVERSITY AND ASSOCIATE PROFESSOR AT HARVARD MEDICAL SCHOOL. Dr. SKOTKO IS A LEADER ABOUT DIN SYNDROME AND FEATURED IN THE WALL STREET JOURNAL, "NEW YORK TIMES," "WASHINGTON POST," L.A. TIMES AND ON POINT AND ABC'S "GOOD MORNING AMERICA." HE HAS A SISTER WITH DOWN SYNDROME AND SERVICE FOR THE MASSACHUSETTS DOWN SYNDROME CONGRESS. BRIAN, THANK YOU FOR JOINING US TODAY. I'LL STOP SHARING MY SCREEN AND THE FLOOR IS YOURS. >> THANK YOU SO MUCH AND THANK YOU TO EVERYONE AT NIDCD FOR ALL OF YOUR HELP THROUGHOUT THIS PROJECT AND INVITING US TODAY TO BE ABLE TO SHARE THESE RESULTS. AS YOU MENTIONED, IT IS A MULTI-TEAM EFFORT AND SO I COULDN'T DO IT WITHOUT MY PARTNERS IN CRIME, Dr. CHRIS HARTNICK. I WANT TO ACKNOWLEDGE HIS CONTRIBUTIONS AND MENTION THESE SLIDES WERE CREATED IN COOPERATION WITH CHRIS. ON MY NEXT SLIDE, I'VE HAD THE OPPORTUNITY TO BE INVOLVED IN MANY ACTIVITIES WITHIN THE DOWN SYNDROME COMMUNITY BUT ONE I MOST PROUD OF KELLY IS THE ONE YOU MENTIONED AND THAT IS I HAVE AN ADULT SISTER WITH DOWN SYNDROME, KRISTEN, THERE SHE IS. SO SHE MAKES MY WORK AS PERSONALLY MOTIVATED AS IT IS PROFESSIONALLY MOTIVATED. I GET TO DIRECT THE DOWN SYNDROME CLINIC AT MASSACHUSETTS GENERAL HOSPITAL WHERE MY TEAM AND I GET TO FOLLOW-UP ABOUT 600 PATIENTS WITH DOWN SYNDROME EVERY YEAR OF ALL AGES. WE DON'T DO PRIMARY CARE BUT WE PROVIDE DOWN SYNDROME SPECIALTY CARE AND WE OFTEN INTERACT WITH EARS, NOSE AND THROAT SPECIALIST WHICH LED TO THIS COLLABORATION AND THIS PARTICULAR PROJECT. SO, WE'RE GOING TO TALK ALL ABOUT OBJECT STUCK TIVE SLEEP APNEA BUT HOW A TREATMENT FOR OBSTRUCTIVE SLEEP APNEA WE THINK AND WE HOPE COULD ALSO HAVE IMPROVEMENT ON ARTICULATION AND EXPRESSION I HAVE LANGUAGE OPTION FORCE PEOPLE WITH DOWN SYNDROME. I'LL LEAVE SPACE TO TAKE QUESTIONS AND HEAR YOUR SUGGESTIONS. IT'S WHEN THERE'S A DECREASE OR A CESSATION OF AIR FLOW INTO YOUR LUNGS WHEN YOU ARE SLEEPING. SO IF YOU LOOK AT THIS CARTOON ON THE RIGHT, YOU CAN SEE THAT AIR FLOW COMES THROUGH OUR MOUTH AND OUR NOSE. WHEN THE TONGUE IS APPROPRIATELY ELEVATED, THE AIR CAN GET THROUGH WHEN YOU ARE SLEEPING ON YOUR BACK AND INTO YOUR LUNGS. FOR MANY PEOPLE, INCLUDING PEOPLE WITH DOWN SYNDROME THAT HAVE HYPO TONIA OR LOW MUSCLE TONE IN THE TONGUE, IT WILL ROW LAX AND FALL BACK AND IT OBSTRUCT THE AIRWAY AND YOU HAVE A DECREASE OR BLOCKED AIRWAY GETTING THROUGH. THERE ARE SOME STRUCTURES THAT CAN GET IN THE WAY LIKE TONSILS OR ADENOIDS AND SOME OF THE CLASSIC SIGNS AND SYMPTOMS ARE SNORING, CHOKING OR GASPING DURING SLEEP. MANY PEOPLE WITH DOWN SYNDROME FROM SILENT OBSTRUCTIVES SLEEP APNEA WHICH IS OFTEN TIMES THE MOST DIFFICULT TO DETECT BECAUSE IT GIVES US NO CLUES WHATSOEVER, WHILE YOU ARE SLEEPING, AND WE NEED TO LOOK FOR OTHER CLUES LIKE CHANGES IN BEHAVIOR OR CHANGES IN COGNITION. MANY OF YOU KNOW THAT UNTREATED OBSTRUCTIVE SLEEP APNEA, FOR THE KNEW OWE TYPICAL POPULATION COMES WITH A LOT OF CO MORBID TEASE, WHEN YOU ADD DOWN SYNDROME, COMES WITH IT INTELLECTUAL DISABILITY IT COMPOUNDS THIS. IT CAN LEAD TO SHORT AND LONG-TERM COGNITIVE DEFICITS. THE BRAIN FOGGY AND FEELING LIKE YOU ARE NOT GETTING A GOOD SLEEP NIGHT AFTER NIGHT, WHEN YOU ARE NOT HAVING A GOOD NIGHT'S SLEEP AND YOU ARE GOING TO BE ON EDGE AND EXACERBATE OR LEAD TO SOME BEHAVIORAL DISTURBANCES. WHEN YOU CANNOT CONCENTRATE, WHEN YOU ARE HAVING BEHAVIORAL ISSUES, YOU ARE NOT ABLE TO ATTEND AT SCHOOL AND OBSTRUCTIVE SLEEP APNEA IS ONE OF THE BIGGEST CHALLENGES IN TERMS OF ACADEMIC PERFORMANCE, OFTEN TIMES LEADING TO SCHOOL FAILURE. ON THE MEDICAL SIDE, IT LEADS TO HYPERTENSION, HIGH BLOOD PRESSURE, WE START TO DEVELOP HEART ISSUES AND VASCULAR ISSUES AND LEAD TO FAIL YOUR TO THRIVE AT ITS WORSE, PULMONARY HYPERTENSION AND EXACERBATE TO DEATH. THE GOOD NEWS, SURGICAL AND MEDICAL TREATMENT CAN PREVENT OR EVEN REVERSE THESE OUTCOMES SO EARLY DETECTION IN TREATMENT IS REALLY KEY. AND THE REASON WHY OSA IS SO COMMON IN PEOPLE WITH DOWN SYNDROME BECAUSE OF THE DIFFERENT CRANIO FACIAL AN AT MOW. THERE'S A MIDFACE AND MAN DISABILITY YOU LAR HYPO PLAY SHA AND THE TYPES OF THE TONGUE IN RELATION TO A SMALLER MIDFACE LEADS TO RELATIVE MACROGLOSSIA OR BIGGER TONGUE. IT CAN PROTRUDE. THE ADENOIDS ARE ENLARGED AND IT GROW BACK LARGE AGAIN. WE HAVE LARGE POSITIONED TONSILS AND INCREASE SECRETIONS, OBESITY GOES ALONG WITH MORE THAN 50% OF PEOPLE WITH DOWN SYNDROME CONTRIBUTING TO PRESSING DOWN ON THAT NECK WHEN THEY'RE IN THE SUPINE SLEEPING. 1-4% OF THE PEDIATRIC AGE NEURO WILL DEVELOP OSA AND 10% TO 25% IN THE ADULT POPULATION. WHEN IT COMES TO PEOPLE WITH DOWN SYNDROME OF ALL AGES, 55 TO 97% DEPENDING ON WHICH STUDY YOU READ AND WHICH COUNTRY YOU ARE IN. IT'S PREVALENT, VERY PERSISTENT AND RECURRENT. I HAVE TO SAY AS A PRACTICING PHYSICIAN, IT'S ONE OF THE CONDITIONS THAT I MOST OFTEN AM TALKING ABOUT AND MOST OFTEN STRUGGLING WITH OUR FAMILIES TO FIND APPROPRIATE TREATMENT. AS PART OF MY PRESENTATION TODAY, I'M GOING TO REFER TO AHI. I WANT TO GIVE YOU THE DECODER RING THAT WILL HELP ANALYZE MY FUTURE SLIDES. AHI STANDS FOR THE APNEA-HYPOPNEA INDEX. IT'S HOW SEVERE OBSTRUCTIVE SLEEP APNEA. THE NUMBER REFERS TO HOW MANY EVENTS PER HOUR IS SOMEONE NOT GETTING ENOUGH OXYGEN. IF I SAY THE AHI IS 2, IT WOULD BE TWO TIMES EVERY HOUR WHEN SOMEONE IS SLEEPING THEY'RE NOT GETTING ENOUGH OXYGEN. IN THE PEDIATRIC POPULATION, WE CLASSIFY OBSTRUCTIVE SLEEP APNEA THE FOLLOWING AWAY, LESS THAN ONE PER SHOWER NO APNEA. ONE TO FIVE IS MILD, FIVE TO 10 IS MODERATE AND GREATER THAN 10 IS SEVERE. WHAT DO WE DO IF WE FIND OBSTRUCTIVE SLEEP APNEA IN SOMEONE WITH DOWN SYNDROME, THE FIRST STEP IS WE TURN TO OUR COLLEAGUES IN EARS, NOSE AND THROAT TO SEE IF THERE'S ANY SURGICAL OPTIONS AND THIS IS A PATIENT OF MINE WHERE IF YOU STARING, YOU CAN SEE THERE ARE THOSE TONSILS. IT'S NOT HARD TO IMAGINE WHY THIS PATIENT WITH DOWN SYNDROME HAS SEVERE OBSTRUCTIVE SLEEP APNEA BECAUSE HOW IS OXYGEN GOING TO GET BACK ESPECIALLY WHEN THAT CHILD IS SLEEPING IN THE TONGUE IS GOING TO COLLAPSE ON TOP OF THAT. SO WE WILL GO TO OUR EARS, NOSE AND THROAT DOCTOR, REMOVE THE TONSILS AND THE ADENOIDS AND TYPICALLY ABOUT EIGHT WEEKS AFTER SURGERY, WE WILL REPEAT THE SLEEP STUDY TO SEE IF THAT DID THE TRICK AND IT CLEANED UP THE APNEA. SOMETIMES IT DOES AND SOMETIMES IT DOESN'T WHEN IT DOES, IT DOESN'T MEAN THAT APNEA IS CURED FOR LIFETIME, AGAIN, THE ADENOIDS CAN COME BACK AND OTHER CONDITIONS LIKE OBESITY OR OTHER MEDICAL CONDITIONS CAN EMERGE FOR THAT APNEA CAN REEMERGE. WE GO BACK FOR SURGICAL OPTIONS UNTIL OUR EARS, NOSE AND THROAT FAMILIES TELL US WE'VE RUN OUT OF SURGICAL OPTIONS AND AT THAT POINT IF THEY'RE STILL OBSTRUCTIVE SLEEP APNEA WE TURN TO CPAP. MANY OF YOU MIGHT KNOW PEOPLE WHO NEED TO WEAR THE MASK AT NIGHT. IT CAN COVER THE NOSE, OR THE MOUTH OR BOTH. THIS IS A SMILING CHILD BUT I HAVE TO TELL YOU NOT MANY OF MY PATIENTS WITH DOWN SYNDROME ARE SMILING WHEN THEY FIRST GET THE OPPORTUNITY TO WEAR A MASK. PEOPLE WITH DOWN SYNDROME OFTEN TIMES HAVE SOME SENSITIVITIES, PARTICULARLY IN THEIR FACIAL AREAS. SO GETTING THEM TO WEAR IT LET ALONE TURN IT ON IS A CHALLENGE. IT'S NOT AN INSURMOUNTABLE ONE. WE'VE TAKEN NICE AND SLOW, OFTEN TIMES WE'LL WORK WITH OCCUPATIONAL THERAPISTS WHO ARE EXPERTS IN DESENSITIZIZATION TECHNIQUES AND SLOWLY BUT SURELY WE GET THE CHILDREN AND THE ADULTS USED TO WEARING THEIR OBSTRUCTIVE C PAP MASK. WITH THEY GET IT, PEOPLE WITH DOWN SYNDROME ARE GOOD AT DEVELOPING ROUTINES SKILLS AND OFTEN TIMES THEY'LL CONTINUE TO WEAR IT IN THEIR GOOD CPAP USERS AND THEY FEEL THE BENEFITS ARE REALLY BEING REFRESHED WITH THE CPAP MASK. MANY PEOPLE WITH DOWN SYNDROME JUST CAN'T GET A HOLD OF THE CPAP AND THIS IS TRUE FOR THOSE INDIVIDUALS WITH DOWN SYNDROME THAT MIGHT HAVE OTHER CO OCCURRING CONDITIONS LIKE AUTISM OR OTHER SENSITIVITY DISORDERS AND THOSE CASES, AS A PHYSICIAN, WE EITHER HAVE TO LIVE WITH IT, KNOWING WE HAVE PARTIALLY TREATED ABNEY A, THEY'RE NOT GOING TO WEAR THE MASK FOR ALL OF THE NIGHT AND IT JUST IS WHAT IT IS AND WE START TO SEE THE HEALTH CONSEQUENCES OR WE HAVE SOMETHING NEW THAT CAME ON THE SCENE. THE HYPOGLOSSAL NERVE STIMULATER AND IT'S THE MOTOR NERVE IN THE TONGUE THAT HELPS REGULATE THE MOTOR FUNCTIONS OF THE TONGUE AND THE WAY THIS WORKS IS IN A INVASIVE SURGERY YOU HAVE A SMALL BATTERY PACK THAT IS INSERTED UNDER THE SKIN BY THE ENT SURGEON AND YOU HAVE A LEAD THAT CONNECTS TO THE LUNGS AND IT CLIPS ON AND CONNECTS TO THE BACK OF THE HYPO GLOSSAL NERVE. YOU HAVE A REMOTE CONTROL THAW LITERALLY CAN OPERATOR YOUR CAREGIVER WITH OPERATE AND WHEN YOU TURN THAT ON, IT ACTIVATES YOUR BATTERY TO TURN ON WHEN IS THE LUNGS SAY IT'S TIME TO BREATH, IT GIVES A SIGNAL TO THE TONGUE, THE HYPOGROUP AS NERVE SAYS MOVE IT AND YOU ARE LIFTING THE TONGUE SLIGHTLY PROTRUDING IT OUT WHICH ALLOWS THE AIR TO GETS THROUGH. THAT IS THE BASICS OF THE HYPOGLOSSAL NERVE STIMULATER. THIS IS AN FDA-APPROVED DEVICE FOR ALL ADULTS 18 AND OLDER AND IT CAME ON TO THE SCENE IN THE NEW ENGLAND JOURNAL OF MEDARD CAL IN 2014. I REMEMBER WHEN THIS ARTICLE CAME OUT Dr. HARTNICK AND I STARTED DISCUSS PARTICULAR AND WE SAID, COULD THIS POTENTIALLY BE AN OPTION FOR OUR PATIENTS WITH DOWN SYNDROME. I HAVE ALL THESE PATIENTS WHO CAN'T TOLERATE THEIR CPAP AND THAT'S WHAT STARTED THE GENESIS OF OUR WORK TOGETHER. SO, WE GOT Dr. HARD NICK GOT A GRANT OF WHICH I WAS A PART OF TO BEGIN WITH AND WE HAVE NOW COMPLETED THE SAFETY AND EFFICACY TRIAL IN CHILDREN AND ADOLESCENCE WITH DOWN SYNDROME. THIS LED TO OUR CURRENT GRANT WHICH I'M GOING TO TELL YOU ABOUT AT THE END OF THE PRESENTATION "THE SOURCE" WE HAVE DATA ON THE -- IT WAS AS SAFE AS IT WAS IN THE NEURO TYPICAL POPULATION THAT WAS PUBLISHED WHILE WE WERE AT IT WE WANTED TO TAKE A LOOK AT EFFICACY. AND I'M GOING TO SHOW WHAT YOU THOSE MEASUREMENTS ARE ON THE ACCIDENT SLIDE. TO BE ELIGIBLE FOR THIS WE WERE LOOKING FOR PEOPLE WITH DOWN SYNDROME 10 TO 21 YEARS OF AGE WHO HAD AGAIN IN PHASE 1 SEVERE APNEA SO THAT IS 10 OR HIGHER EVENTS AND WE CAPPED IT AT 50. WE ALSO NEW FROM PREVIOUS PUBLICATIONS THAT HYPO GLOSSAL NERVE STIMULATER DID NOT PERFORM WELL IN THE NEURO TYPICAL POPULATION THAT WAS OBESE BECAUSE THE EXTRA ADD A POSE TISSUE AROUND THE NECK WOULD OFTEN UNDUE AND STILL PRESS DOWN AND NOT BE ABLE TO OVERCOME THE BENEFITS OF THE HYPO GLOSSAL NERVE STIMULATER SO WE HAD ELIGIBILITY TO A BODY MASS INDEX THAT WAS LESS THAN THE OBESITY CATEGORY. THE INDIVIDUALS MUST HAVE PERSISTENT OBSTRUCTIVE SLEEP APNEA AND THEY ALREADY HAD THE BASICS DONE. TON TILLS AND ADENOIDS DONE. THEY COULD NOT OR COULD NOT TOLERATE CPAP AND THEY HAD SEVERE AP APNEA AND DOWN SYNDROE AND THE SEVERE APNEA. THESE ARE THE ONES WE REACHED OUT AND OFFERED THEM TO BE A PART OF OUR FIRST CLINICAL TRIAL MUCH THIS IS THE WAY THE PROCESS WORKED. WE GOT A BASELINE SLEEP STUDY THAT WAS DONE PRIOR TO THE STUDY AND NEEDED TO BE SIX MONTHS OR LESS PRIOR TO THE STUDY TO CONFIRM THAT THEY WERE IN THAT SEVERE CATEGORY. THEY ALSO HAD A DRUG-INDUCED SLEEP ENDOSCOPY IN ORDER TO MAKE SURE ALL THE ANATOMY WAS SUCH IT WAS OPTIMIZED FOR THE HYPO GLOSSAL NERVE STIMULATER TO BE EFFECTIVE AS DOM ON STRAIGHTED. WE REVIEWED THAT AND COU CONSEND PEOPLE TO BE PART OF THE STUDY. IT STARTED MONTH ZERO WHEN THE ELIGIBLE PATIENTS RECEIVED THAT HYPO GLOSSAL NERVE IMPLANT BY ONE OF THE ENT SURGEONS THAT ARE PARTICIPATING INSTITUTIONS AND WE JUST LET EVERYTHING HEAL. A MONTH LATER IS WHEN THEY CAME BACK AND THAT'S WHEN IT WAS ACTIVATED SO WE TURNED ON THAT HYPO GLOSSAL NERVE IMPLANT FOR THE FIRST TIME. AND THEN THEY CAME BACK AT MONTH TWO IN ORDER TO TWEAK IT AND WHAT IS WORKING AND NOT WORKING AND CAN WE GO UP IN ORDER TO MAXIMIZE THE TREATMENT FOR OBSTRUCTIVE SLEEP APNEA AND THEY CAME BACK AT MONTH SIX AND WE DID IT AGAIN AND AT MO AT MONTH, OUR GOAL WAS TO SEE WHETHER OR NOT WE COULD DECREASE THE SEVERITY OF THE OBSTRUCTIVE SLEEP APNEA BY IMPLANTING A HYPO GLOSSAL NERVE STIMULANT. OUR PRIMARY OUTCOME MEMBERS WITH AHI, HOW SEVERE IT WAS FROM BASELINE TO 12 MONTHS WERE WE ABLE SHOW AN IMPROVEMENT? WE SPECIFIED THAT WE WOULD SAY IT WAS SUCCESSFUL IF AN INDIVIDUAL DECREASED THEIR AHI BY 50% OF WHAT THEIR BASELINE WAS. SO DID WE CUT IT IN HALF BY GIVING THEM HYPO GLOSSAL NERVE STIMULATER. WE HAD SECONDARY OUTCOME MEASURES. WE WANTED TO SEE HOW MUCH OF THE TIME WE HAD A GOOD OXYGENATION DURING NIGHT AND WE DIDN'T WANT IT LOW SO YOU WANT IT HIGHER THAN 90% AND WE WANT TO IMPROVE THE CARBON DIOXIDE AND WE DIDN'T WANT IT HIGH WE WANTED TO LOWER IT AND WE WANTED TO MEASURE QUALITY OF LIFE SCORES THROUGH CAREGIVER PROXY REPORTS AND WE DID THAT THROUGH THESE TWO VALIDATED QUESTIONNAIRES THE OSA18 AND THE ESS. I'M PROUD TO SHARE WITH YOU THE RESULTS OF THIS PUB PAPER. WE HAVE THE DEMOGRAPHICS OF OUR FIRST 42 PEOPLE WHO VOLUNTEERED IN THIS STUDY WE HAD A MIXTURE OF MALE AND FEMALE. THE AGES IN OUR INCLUSIONARY CRITERIA, 10 TO 21 AND DEFINITION NO ONE COULD BE IN THE OBESITY CATEGORIES SO THEY FELL IN THE NORMAL WEIGHT OR THE OVER WEIGHT CATEGORY. WE WERE ABLE TO SHOW THAT THE IMPLANT WAS SAFE. THAT WAS OUR FIRST AND FOREMOST TO MAKE SURE IN OUR POPULATION IT WAS SAFE. SOME OF THE NON SERIOUS ADVERSE EVENTS THAT OCCURRED HERE WERE WHAT WERE SEEN IN THE NEURO TYPICALLY DEVELOPING ADULTS THAT THE NERVE STIMULATER IMPLANTED AND THERE WAS DISCOMFORT AND A RASH AT THE SITES AND CHEEK SWELLING ALL OF WHICH RESOLVED AND WERE TEMPORAL IN NATURE. OF THE SERIOUS ADVERSE EVENTS OF OUR FIRST PATIENTS, WE HAD FIVE THAT REQUIRED REEMISSION AND ONE OF WHICH WAS UNRELATED TO SURGERY OF THE FOUR THAT WERE RELATED TO SURGERY, TWO OF THEM WERE FOR INDIVIDUALS THAT HAD A HABIT OF PICKING. SO AFTER THEY WENT HOME, THEY CONTINUED TO PICK AT THEIR SCAB AND PICK ALL THE WAY THROUGH TO EXPOS THE LEAD IN THE HYPO GLOSSAL NERVE STIMULATER AND IT WAS A READMISSION WITH ANTIBIOTICS AND THEY RECOVERED AND WERE ABLE TOE CLOSE THAT WOUND. THE LESSONS LEARNED IS FOR THOSE WHO HAVE DOWN SYNDROME AND AUTISM OR THOSE WITH SOME SERIOUS SENSITIVITY ISSUES AND MAKING SURE THAT THE BANDAGING IS ON THERE FOR A LONG AMOUNT OF TIME TO PREVENT PICKING FROM HAPPENING. THE OTHER TWO WERE BRIEFLY REEMITTED BECAUSE OF DISCOMFORT AND PAIN. WE'RE ALSO HAPPY TO SAY THAT THE IMPLANT WAS EFFECTIVE IN OUR FIRST PHASE 1 TRIAL. AHI WAS OUR MAIN OUTCOME. THE MAIN BASELINE AGAIN APNEA INDEX THE OBSTRUCTIVE COMPONENT HERE IS HOW MANY TIMES PER HOUR IS SOMEONE NOT GETTING SUFFICIENT OXYGEN WHEN THEY'RE SLEEPING. ON AVERAGE IT WAS 22 TIMES PER HOUR AND BY 12 MONTHS IT WAS DECREASED TO 10.1 SO WE HAD A CHANGE OF 12.2 DECREASE IN AHI. WE LOOKED AT THE HIGH POP NIA PORTION FROM BEGINNING TO END. THIS STAYED THE SAME. THE LOWER LEVELS INCREASES JUST A LITTLE BIT. YOU LOOK AT OXYGENATION TIME, AGAIN, WE WANT MORE OXYGENATION GREATER THAN 90% SO A DECREASE IS A GOOD DIRECTION AND WE WERE ABLE TO DECREASE IT THERE AND WE WANTED TO MAKE SURE WE HAD AN IMPROVEMENT ON CARBON DIOXIDE SO LESS CARBON DIOXIDE COMING OUT SO A DECREASE IS GOOD THERE AS WELL. SO, OVER ALL, THE TAKE-HOME MESSAGE WAS THERE WAS A DECREASE IN A HI OF ABOUT 12.9% WHICH WAS STATISTICALLY MEANINGFUL BETWEEN THEN AND NOW AND WE DEFINE THE RESPONSES HOW MANY INDIVIDUALS CUT THEIR OBSTRUCTIVE SLOPE APNEA IN HALF AND OUR RESPONSE RATE FOR THAT WAS 65.9%. 73% OF PATIENTS AT THE END, HAD A 12-MONTH AHI UNDER 10. 0 IS HAVING SEVERE OBSTRUCTIVE SLEEP APNEA AND AS A PRACTICING PHYSICIAN, I WANT IT AS LOW AS POSSIBLE BECAUSE ANY AMOUNT OF APNEA HAS AN EFFECT. SO THE DEVICE WAS WELL TOLERATE AND THE AVERAGE NIGHTLY USE WAS 8.9 HOURS. UNLIKE CPAP WHERE THEY'RE PULLING IT OUT DURING THE NIGHT THIS WAS WELL TOLERATE AND YOU TURN IT ON AND YOU TURN IT OFF. WE NEED TO TALK ABOUT THESE RESULTS, BECAUSE WHILE THEY WERE VERY EFFECTIVE, AND VERY BENEFICIAL, IT'S NOT 100%. AND SO, WE'LL TALK ABOUT HOW WE'RE IMPROVING ON THESE PREVIOUS MEASURES. I MENTIONED THAT WE TOOK A LOOK AT QUALITY OF LIFE AND THESE WERE TWO VALIDATED QUESTIONNAIRES THAT WE USED BY PARENT PROXY REPORTS. THE OSA18 INSTRUMENT WAS HOW BAD ARE YOUR SLEEPING SYMPTOMS THROUGHOUT THE NIGHT AND SO A DECREASE IN SCORE IN THE TOTAL SCORES IS WHAT WE'RE LOOKING FOR SO BASELINE 66 DECREASED TO 31.3 AND SO WE HAD A DECREASE OF 34 IN THE RIGHT DIRECTION OF IMPROVEMENT AND THE SLEEPINESS SCALE HIGHER IS WORSE AND SO DECREASE IN THAT SHOWS THE CAREGIVER FEELS THERE'S LESS SLEEPINESS DURING THE DAY AND WE SAW THAT THE CAREGIVERS RATED THAT LOWER. AGAIN, IT WASN'T A BLIND STUDY BUT WE ALSO NOTE THAT CAREGIVERS REALLY ARE ON THE FRONTLINES AND WE WERE HAPPY TO NOTICE IT WASN'T JUST THE DEVICE, CARRYING A MATHEMATICAL NUMBER BEHIND THE SCENES BUT PARENTS NOTICED IMPROVEMENT IN THE QUALITY OF LIFE OF THE PATIENTS WITH DOWN SYNDROME. SO WHAT ARE OUR LESSON LEARNED THAT CHRIS AND I TOOK FROM THE FIRST 42 PATIENTS? SO, HAVING 73% OF OUR PATIENTS NOW OUT OF THE SEVERE OBSTRUCTIVE SLEEP APNEA CATEGORY IS GOOD. WE'RE HAPPY WITH THAT. BUT WHY NOT BETTER, RIGHT? WE KNOW THAT THERE IS ONE STUDY THAT CAME OUT THAT SHOWED THAT OBSTRUCTIVE SLEEP APNEA, IF IT'S AN AHI OF TWO OR MORE, CAN LEAD TO A LOSS OF NINE I.Q. POINTS IN OUR PATIENT POPULATION SO IN THE IDEAL WORLD AS A PRACTICING CLINICIAN AND AS MY PATIENTS AND PARENTS WANT, WE DON'T WANT ANY APNEA WE WANT THE AHI LESS THAN TWO BUT IN A POPULATION HERE THAT WAS OTHERWISE LIVING WITH SEVERE OBSTRUCTIVE SLEEP APNEA WITH NO OTHER OPTIONS AVAILABLE, WE WERE AT LEAST ABLE TO KNOCK MANY OF THEM DOWN IN HALF AND REDUCE THE LEVEL OF AHI BUT HOW DO WE MAKE IT BETTER? HOW DO WE EVEN AIM FOR IF IT'S POSSIBLE THE GOAL, LOWER THAN A AHI OF 2? IS THAT WHAT WE SHOULD BE AIMING FOR? IS THERE ANOTHER AHI WE SHOULD AIM FOR? SHOULD AHI BE THE PRIMARY OUTCOME OR OTHER QUALITY IMPROVEMENT OUTCOMES WE LOOKED FOR. THESE WERE ALL OF THE LESSONS WE LEARNED AFTER OUR FIRST 42 PATIENTS. AS ALWAYS, A REALLY GOOD STUDY IS WHEN YOU LISTEN TO YOUR PATIENTS AND THEY SAY, BY THE WAY, WE'VE NOTICED THIS AND THIS AND THIS. WE HAD MANY PARENTS COME TO US AND SAY YES, THE SLEEP IS BETTER DOCTOR AND YES IT'S IMPROVED BUT I HAVE TO SAY, I FEEL MORE REFRESHED AND WE'RE SEEING THAT THEY'RE SHARPER AND THE TEACHERS ARE SAYING THEY'RE SHARPER AT SCHOOL. WELL, WE HOPE THAT WOULD BE THE CASE AND IT WAS GREAT. WE KNOW A REFRESH SLEEP AND FULL OK AGAINATED TANK OF GAS IF YOU WILL OVERNIGHT SLEEP SHOULD MAKE US MORE ALERT IN SCHOOL BUT IT WAS NICE TO GET SOME OF THAT FEEDBACK FROM THE PARENTS. BUT A LOT OF PARENTS CAME TO US AND SAID, THAT THE ARTICULATION OR THE EXPRESS I HAVE LANGUAGE WAS IMPROVED IN THEIR LOVED ONES WITH DOWN SYNDROME AND I DID NOTICE THIS AND SOME OF PATIENTS WITH DOWN SYNDROME. FOR THOSE OF US WHO KNOW A LOT OF PEOPLE WITH DOWN SYNDROME, WE CAN SEEK DOWN SYNDROME TO GET USED TO THE SPEECH HABITS BUT EVEN SOME OF MY PATIENTS WHO ARE MORE DIFFICULT TO APPRECIATE AR EXPRESS I HAVE LANGUAGE, AFTER ABOUT 12 MONTHS OF TREATMENT, THE ARTICULATION WAS BETTER AND THEY FELT CONFIDENT AND WE DID START TO NOTICE AND SPEECH OUTCOMES. BUT AGAIN, THIS WAS ANECDOTAL, SO, CHRIS AND I WANTED TO, AT THE END OF THE STUDY, START TO COLLECT PRELIMINARY RESEARCH TO SEE WHETHER OR NOT THIS WAS A TESTABLE CASE AND WHETHER OR NOT WE SHOULD PURSUE THIS WITH THE PREVIOUS GRANT. 16 CAREGIVERS REPORTED OBJECTIVE ASSESSMENTS OF POSITIVE NEURO COGNITIVE CHANGES AND 14 OF THESE 16 CAREGIVERS ALSO TALKED ABOUT SPEECH. SO WHAT WE TRIED TO DO WAS PILOT STUDY FOR THE LAST SIX PATIENTS THAT WERE IMPLANTED AT OUR HOSPITALS PART OF THIS FIRST RESEARCH. AND WE ADDED ON PRE AND POST NEURO COGNITIVE TESTING AND LOOKED AT EXPRESS I HAVE LANGUAGE TESTING. AS A WAY OF COLLECTING MORE PRELIMINARY DATA THAT IF ENCOURAGING WOULD ALLOW US TO APPLY FOR AN ADDITIONAL GRANT AND HERE IS WHAT OUR PRELIMINARY DATA LOOKED LIKE. WE WORKED WITH OUR NEURO COGNITIVE PSYCHOLOGISTS WHO REALLY HAD BEEN INVOLVED IN LOTS OF DOWN SYNDROME CLINICAL TRIALS BEFORE TO COME UP WITH A GREAT BATTERY OF TEST AND MIGHT BE ABLE TO CAPTURE THE ELEMENTS OF COGNITION THAT WE HOPE WOULD BE IMPROVED IF SLEEP APNEA WAS IMPROVED AND AGAIN, IN THE PILOT POPULATION, VERY SMALL NUMBERS, ON THESE DOMAINS OF COGNITIVE TESTING, YOU CAN SEE FROM BASELINE TO FOLLOW-UP THE SCORES IMPROVED AND ON EACH DOMAIN A HIGHER NUMBER IS BETTER SO THIS WAS ENCOURAGING AND ALSO MATCHED WHAT WAS PERCEIVED BY THE CAREGIVERS WHO WERE TAKING CARE OF OUR PATIENTS WITH DOWN SYNDROME. WE ALSO PARTNER WITH LEN WHO IS A LEADING EXPERT ON MEASURING EXPRESS I HAVE LANGUAGE IN INDIVIDUALS WITH DOWN SYNDROME AND MORE IMPORTANTLY COMING UP WITH A MEASURE BY WHICH THAT CAN BE QUANTIFIED AND ANALYZED OVER TIME. >> Dr. Becky Wagenaar-Miller: F UTTERANCES A PERSON WITH DOWN SYNDROME WILL SAY WITH A PICTURE STORY X MORE IS BETTER. SO FROM BEGINNING TO END, WE DID NOTICE THERE WAS AN IMPROVEMENT ON THIS TEST. WHICH AGAIN, WAS ABLE TO SUPPORT SOME OF THAT ANECDOTAL EVIDENCE I WAS NOTICING IN CLINIC AND PARENTS WERE REPORTING ABOUT EXPRESS I HAVE LANGUAGE SO AS A RESULT OF THAT, WE TOOK OUR PREVIOUS RESULTS AND SAID WE WERE ABLE TO SHOW THAT AT LEAST MEDICALLY WE WERE ABLE TO REDUCE THE APP SLEEP APNEA BUT WE'RE ALSO NOTICING THAT MAYBE PERHAPS THERE'S AN IMPROVEMENT IN COGNITION AND ALSO AN IMPROVEMENT IN EXPRESS I HAVE LANGUAGE BECAUSE THAT TONGUE, THAT MUSCULAR ORGAN IS GROWTH A WORKOUT AND PERHAPS JUST BY ACTIVATING THAT TONGUE OVERNIGHT, WE'RE IMPROVING THE EXPRESS I HAVE LANGUAGE. WE TOOK OUR PRELIMINARY DATA AND APPLIED FOR A GRANT AND WE'RE VERY GRATEFUL FOR NIDCD AND INCLUDE FUNDING FORAY WARDING THUS UO1 WHICH IS A COLLABORATIVE GRANT WITH THE NIH TO NOW TAKE A LOOK ANOTHER WHEN WE'RE IMPLANTING THE OBSTRUCTIVE SLEEP, HYPO GLOSSAL NERVE STIMULATER ARE WE SEE EFFECTS ON COGNITION AND LANGUAGE. AND SO, OUR STUDY PROCEDURE IS THE SAME AS IT WAS BEFORE BUT NOW WE'VE ADDED THE BLUE COMPONENTS. SO WE'RE STILL GOING TO HAVE THAT BASELINE SLEEP STUDY AND THEY STILL HAVE TO HAVE SEVERE OBSTRUCTIVE SLEEP APP KNEE AND THEY NEED TO BE AN ATOMICALLY SET UP FOR SUCCESS BUT AT MONTH ZERO IN ADDITION TO IMPLANTING THEM WE'RE DOING BASELINE NEURO TESTING AND BASELINE EXPRESS I HAVE LANGUAGE SAMPLING AND ONE MONTH LATER WE ACTIVATE IT AND THREE MONTHS LATER, WHEN WE DO THE SLEEP STUDY AT THREE AND SIX AND 12 WE'RE ADDING ON THE NEURO COGNITIVE TESTING COMPONENT AND THE OUR HOPE AND OUR HYPOTHESIS IS, THAT FROM MONTH ZERO TO MONTH 12, WE'LL BE ABLE TO DEMONSTRATE A SIGNIFICANT IMPROVEMENT ON NEURO COGNITIVE TESTING SCORES AND EXPRESS I HAVE LANGUAGE SAMPLE EGG SCORES IN A LARGER PATIENT POPULATION. THIS IS NOW BLOOMED INTO A BIG MULTI-DISCIPLINARY MULTI-SITE TEAM. AGAIN, NOT POSSIBLE WITHOUT ALL OF GROUPS TAKING PART. WE HAVE TEAMS FROM SIN SIN, PITTSBURGH, ATLANTA, VIRGINIA, SOUTHWESTERN AND ALL PARTICIPATING ON EACH OF THOSE TEAMS AND WE HAVE AN EARS, NOSE AND THROAT SURGEON AND A COORDINATOR AND RESEARCH COORDINATOR AND NEURO COGNITIVE BATTERY TEAM. CAN'T THANK ENOUGH ALL OF OUR CENTRAL TEAM AT MASS AND MGH AND I WANT TO THANK LEN FROM UC DAVIS FOR HE BEING THE CENTRAL ANALYSIS TEAM OF OUR EXPRESS I HAVE LANGUAGE SAMPLING AND I WANT TO THANK THOSE REVIEWERS WHO ARE INDEPENDENTLY REVIEWING. THE NIH TEAM WHO REGULARLY JOINED US FOR OUR MONTHLY CALLS AND PROVIDING HELPFUL AND CONSTRUCTIVE FEEDBACK AND JOIN US FOR THIS JOURNEY TOGETHER THAT WE'RE TAKING ON THIS FIVE-YEAR GRANT. I WANT TO THANK YOU FOR THE OPPORTUNITY TO JOIN YOU. I REALLY LOOK FORWARD TO WHEN THIS GRANT IS FINISHED. TO COME BACK AND PRESENTING WITH YOU THE RESULTS. IF ANY OF YOU KNOW PATIENTS WITH DOWN SYNDROME OR LOVED ONES WITH DOWN SYNDROME, WHO YOU THINK MIGHT QUALIFY, PLEASE FEEL FREE TO REACH OUT TO ME AND WE CAN MAKE SURE THEY GET TO A SITE NEAR THEM. THANK YOU FOR THE OPPORTUNITY TO PRESENT AND I WOULD LOVE TO HEAR YOUR COMMENTS OR QUESTIONS. >> THANK YOU SO MUCH, BRIAN. THAT WAS FANTASTIC. BOTH YOU AND MELISSA, THAT WAS A REAL PACKED HOUR WE JUST GOT THERE. I KNOW WE'RE PUSHING UP AGAINST A BREAK BUT WE HEARD A LOT AND LEARNED A LOT AND WE WANT TO TAKE SOME ADDITIONAL TIME TO HEAR COMMENTS AND WE ARE ANSWERS. NIRUPA, YOU ARE FIRST OUT OF THE GATE. >> HELLO, CONGRATULATIONS THAT WAS JUST REALLY, REALLY AN EXCELLENT TALK. SO, I'M WONDERING WHAT YOUR NUMBERS ARE LIKE AND IF YOU HAVE THE POWER TO ACTUALLY LOOK AT THE EFFICACY OF THE PROTOCOL ACROSS AGES BECAUSE AS IN COCHLEAR IMPLANTS, OR ANY OTHER COGNITIVE INTERVENTION, EARLIER WOULD SEEM TO BE BETTER BUT PERHAPS NOT? >> GREAT QUESTION AND I APPRECIATE IT VERY MUCH. SO, OUR ELIGIBILITY AGAIN IS 10 TO UP UNTIL 21 AND 11 MONTHS. AND SO FAR WE'VE RECRUITED 16 INDIVIDUALS WHO FALL INTO THAT AGE CATEGORY. BUT CERTAINLY WE HOPE AT THE END, IF WE HAVE A SPREAD OF AGES, WE WILL TAKE A LOOK AT AGE AND BE ABLE TO PUT IT INTO A MULTI-REGRESSION MODEL TO SEE IF AGE HAS AN IMPACT. I HAVE TO SAY THAT JUST ANECDOTALLY, WHEN I SEE PATIENTS WHO COME TO CLINIC, IF THEY HAVE BEEN SUFFERING AND LITERALLY SUFFERING FROM THE CONSEQUENCES OF UNTREATED SLEEP APP KNEE A. THE LONGER YOU SUFFER, THE MORE YOU HAVE SOME OF THOSE CO OCCURRING DIAGNOSIS AND SO MY STRONG HYPOTHESIS WOULD BE THE EARLIER WE DETECT IT AND THE EARLIER WE COULD TREAT IT, WE'LL HAVE LIFE-LONG CONSEQUENCES BECAUSE FALLING BEHIND ACADEMICALLY, JUST SNOW BALLS IN EFFECTS AS MANY OF YOU KNOW. >> THANK YOU. >> WE'LL GO TO VICKY AND THEN DEB. >> I JUST WANT TO TAG ON TO NIRUPA'S QUESTION RELATIVE TO DEMOGRAPHICS. AND ASK GIVEN MELISSA'S COMMENT ABOUT THE LACK OF DIVERSITY IN A LOT OF THE DOWN SYNDROME INDIVIDUALS WITH DOWN SYNDROME WHO ARE SEEKING SERVICE AND RECEIVING SERVICES, HOW RACIALLY ETHNICALLY AND LINGUISTICALLY DIVERSE YOUR SAMPLES HAVE BEEN AND IF THERE'S ANY POTENTIAL FOR EXPANDING THAT? >> I APPRECIATE THE QUESTION. AS MELISSA SAID, DOWN SYNDROME OCCURS NATURALLY IN INDIVIDUALS OF ALL DIFFERENT RACES AND ETHNIC BACKGROUNDS SO WE KNOW THAT DOWN SYNDROME OCCURS IN ALL OF THOSE AND WE WANT TO MAKE SURE THEY ALL HAVE THE A LOT TO PARTICIPATE. WE'RE PROUD THAT OF OUR FIRST 16 PARTICIPANTS, TWO HAVE SELF-IDENTIFIED AS BEING BLACK, SO WE HAVE RACIAL DIVERSITY SO FAR OUT THE GATE. AS PART OF OUR GRANT AND PART OF OUR MONTHLY MEETINGS, WE HAVE A STANDING AGENDA ITEM ON REACHING THE UNDER REPRESENTED AND MINORITY POPULATIONS. THAT STARTED WITH THE STRATEGIC SELECTION OF OUR SITES SO OUR SITES BY BEING DEMOGRAPHICALLY DIVERSE, WE HOPE WE WOULD BE ABLE TO CAPTURE DEMOGRAPHICALLY DIVERSE POPULATIONS AND THAT IS SO FAR IS PROVING TO BE BENEFICIAL BUT IT'S NOT ENOUGH. WE'VE ALSO LEARNED LOUD AND CLEAR FROM OUR COMMUNITY THAT IT TAKES A TRUSTED MESSAGER TO REALLY ENGAGE IN RESEARCH AND FROM A SEPARATE GRANT THAT I'M INVOLVED WITH THROUGH THE PEE CORY INSTITUTE WE'VE BEEN LOOKING AT HOW BETTER TO ENGAGE INDIVIDUALS WHO IDENTIFY AS BLACK OR COMING FROM PRIMARILY SPINNISH-SPEAKING FAMILIES TO BE INVOLVED IN DOWN SYNDROME-RELATED RESEARCH AND THE NUMBER ONE TAKE HOME FINDING IS HAVE A TRUSTED MESSENGER. WE'RE TRYING TO PARTNER WITH THE SITES AND THEIR LOCAL DOWN SYNDROME ORGANIZATION TO HAVE FAMILY MEMBERS BE ABLE TO ENGAGE IN FAMILY MEMBERS SO A LOT OF OUR OUTREACH REALLY FOR THE PROJECT, IS SPEAKING AT LOCAL DOWN SYNDROME ORGANIZATIONS SO CHRIS SPOKE AT THE NATIONAL DOWN SYNDROME CONGRESS CONVENTION IN NEW ORLEANS THAT HAD A DIVERSE POPULATION TO ALLOW YOU TO MEET THE RESEARCHERS AND SEE THE INTENTIONS AND SEE THIS IS A WELL-INTENTIONED AND WELL-HANGOUT COME. IN TERMS OF LANGUAGE, WHEN WE WROTE THE GRANT IT WAS ENGLISH-SPEAKERS ONLY AND AT THE TIME ALL THE SAFETY MANUALS FOR THE IMPLANT DEVICE FROM THE COMPANY THAT WE'RE PARTNERING WITH, WERE ONLY IN ENGLISH. FOR SAFETY REASONS WE NEEDED TO GO THERE. AS THEY CONVERTED INTO SPANISH SPEAKING WE'RE WORKING WITH A TEAM WITH THE NIH NOW INFORM TRANSLATE EVERYTHING INTO SPANISH SO THAT FOR INDIVIDUALS WITH DOWN SYNDROME, WHO SPEAK ENGLISH OR BILINGUAL BUT HAVE PRIMARILY SPANISH-SPEAKING PARENTS, THEY WILL SOON BE ABLE TO BE INVOLVED IN THE RESEARCH AND WE HOPE THAT IS GOING TO OPEN UP ELIGIBILITY PARTICULARLY FROM OUR SITE IN THE SOUTHWEST AT UT SOUTHWESTERN. IT'S ON GOING EFFORTS, YOU KNOW, AND YOU CAN'T KEEP YOUR EYE OFF THE BALL, SO, WE'RE GOING TO CONTINUE TO MAKE IT A PRIORITY. >> THANK YOU, THAT'S TERRIFIC. MY ASSUMPTION IS THERE PROBABLY IS A GREATER LEVEL OF UNDIAGNOSED SLEEP APNEA IN THOSE POPULATIONS SO THAT OUTREACH WILL BE REALLY BENEFICIAL. THANK YOU SO MUCH FOR YOUR RESEARCH. >> THANK YOU. >> Dr. Debara Tucci: THANK YOU SO MUCH FOR THIS PRESENTATION. THIS IS SUCH AN IMPORTANT PROGRAM AND YOUR PRESENTATIONS WERE REALLY LOVELY AND VERY INFORMATIVE. SO, BRIAN, I HAD A QUESTION FOR YOU. JUST THINKING ABOUT WHY THESE INDIVIDUALS MAY NOT ALWAYS RESPOND IN THE SAME WAY AND YOU MAY HAVE SAID THIS AND I MIGHT HAVE MISSED IT, DID YOU ACTUALLY MEASURE HOW THE STIMULATION AFFECTED TONGUE MOVEMENT? IF IT AFFECTED EACH INDIVIDUAL THE SAME AND IF THERE WAS ALWAYS A MOVEMENT OF THE TONGUE FORWARD? >> GREAT QUESTION. AND THE HYPAL GLOSSAL NERVE STIMULATER HAS DIFFERENT VOLTAGES SO THE ENT DOCTOR IS ABLE TO TIE TRAIT IT SO YOU HAVE MAXIMUM MOVEMENT OF THE TONGUE AT THE MOST MINIMAL SYMPTOMS. SO YOU CAN IMAGINE IF YOU REALLY TURN IT ON, YOU ARE GOING TO FEEL YOUR TONGUE MOVING, WHICH WILL BE VERY UNCOMFORTABLE SO FOR EACH INDIVIDUAL WITH DOWN SYNDROME WAS TRYING TO TIE TRAIT IT TO MAXIMAL MOVEMENT AND ALSO MAKE SURE THAT IT WAS WITHIN THE COMFORT OF THE PERSON WITH DOWN SYNDROME. WHAT WE WERE ABLE TO DO NOTICE AS THE PERSON WITH DOWN SYNDROME PROGRESSED OVER TIME AND GOT USED TO THE FACT, MY TONGUE IS MOVING AND MAYBE IT'S DRY, SOMETIMES THEY WERE ABLE TO BE INCREASED BUT THE MOST MA MATH H CAL INTERPRETATION IS THE VOTE AGE OF THE STIMULATER BUT THAT WAS PERSONALIZED AND CUSTOMIZED INFORM THE INDIVIDUALS. >> Dr. Debara Tucci: GREAT. THANK YOU. >> LISA. >> I HAVE A QUESTION, THIS IS EX TROMLY INTERESTING AND IT'S KIND OF A FOLLOW-UP OF DEB'S. AIM A SPEECH AND LANGUAGE PERSON AND I AM REALLY CURIOUS, YOU KNOW, ABOUT WHY YOU THINK THIS IS FACILITATING YOUR EXPRESS I HAVE LANGUAGE SAMPLE MEASURES -- I CAN THINK OF TWO REASONS. ONE IS WHAT DEB BROUGHT UP REGARDING TONGUE MOTION AND MOTOR CONTROL AND A SECOND REASON MAYBE RELATED THOUGH POSITIVE INFLUENCES, SLEEP ON LEARNING AND CONSOLIDATION BUT I'M REALLY CURIOUS IF YOU CAN ELABORATE ON YOUR HYPOTHESIS ABOUT THIS RELATIONSHIP, ESPECIALLY RELATED TO THIS INTERESTING POPULATION WITH THEIR SPECIAL PROFILE. >> THANK YOU, LISA. MY TWO HIGH POTH SEES ARE IN LINE WITH YOURS. ONE IS, WE KNOW THAT THERE'S GENERALIZED HYPO TONIA IN INDIVIDUALS WITH DOWN SYNDROME THROUGHOUT A LIFETIME AND FOR THOSE OF YOU WHO HAVE MET INDIVIDUALS WITH DOWN SYNDROME, THE TONGUE IS OFTEN TIMES HYPO TONIC AND WHEN YOU ARE SLEEPING, WHEN EVERYTHING IS SHUT DOWN, WE'RE REALLY HYPO TONIC AND YOU HAVE GENERALIZED TYPE ATONIA ON TOP OF THAT SO WE THINK THE MOTOR WORKOUT OF IN AND OUT AND IN AND OUT, REALLY INCREASES THAT MUSCULAR TONE, IF YOU WILL, WHICH IS MAINTAINED THROUGHOUT THE DAY SO WE THINK THERE'S JUST A PRACTICAL MUSCLE WORKOUT THAT IS HAPPENING TO THAT TONE OF THE TONGUE. MY OTHER HYPOTHESIS IS THE ONE YOU MENTIONED THAT IF WE'RE GIVING YOU A BETTER OXYGENATED SLEEP, YOU'RE FEELING REFRESHED AND YYOU WANT TO INITIATE SLEEP. MY SISTER AS OBSTRUCTIVE SLEEP APNEA AND SHE SUCCESSFULLY WEARS A CPAP MASK BUT THERE'S TIMES WE'RE ON VACATION SHE FOR GETS IT AND ET CETERA AND ET CETERA AND I NOTICE HER AND OTHER COLLEAGUES, WHEN THEY'RE SUCCESSFUL MASK USERS THEY'RE MORE LIKELY TO BE WANTING TO ENGAGE IN CONVERSATION VERSUS BEING TIRED. IT'S THE REFRESHED BRAIN AND THE MOTOR WORKOUT. AGAIN, OPEN TO OTHER HYPOTHESIS AND WE'LL SEE WHETHER OR NOT IT PLAYS IN THE LARGE NUMBERS. >> IT WILL BE WONDERFUL TO SEE THESE RESULTS AND YOU WANT TO ATTEND TO THE DEVELOPMENTAL QUESTION LIKE BABIES AND TONGUE MOTION AND IN THIS GROUP AGAIN BUT THANK YOU. >> YOU ARE GOING RIGHT WHERE WE ARE GOING BECAUSE AS SOON AS WE SHOW THAT THIS IS WORKING IN SUCCESSFUL, WHY START AT 10 YEARS OF AGE WE CAN GO EVEN YOUNGER WHICH WE WOULD LOVE TO DO AND THE ONLY THING TO BE IN MIND IS THAT THE HYPO GLOSSAL NERVE HAS THAT LEAD THAT GOES FROM YOUR CHEST UP UNDER TO YOUR TONGUE AND SO THERE'S A LENGTH TO THAT AND THE ENT SURGEONS REALLY YOUNG KIDS PUTS EXTRA SPACE SO YOU CAN GROW INTO IT AND IF YOU ARE REALLY YOUNG, YOU MIGHT NEED A TUNE UPSURGE JUST TO ADD SOME LITTLE LENGTH TO THAT SO THERE ARE THOSE CONSIDERATIONS AND BODIES THAT ARE STILL GROWING. >> TOTALLY MAKES SENSE. THANK YOU SO MUCH. ANY OTHER QUESTIONS FOR BRIAN OR MELISSA? THIS WAS FANTASTIC. I KNEW ABOUT YOUR PRESENTATIONS COMING INTO THIS AND I STILL LEARNED A LOT. THANK YOU BOTH FOR YOUR TIME AND YOUR ENERGY AND FOR BEING WITH US TODAY. DEB, BACK TO YOU. >> Dr. Debara Tucci: GREAT, THANK YOU, VERY MUCH. SO, WE WILL NOW TAKE A 10-MINUTE BREAK AND WE'LL COME BACK AT 5 UNTIL 3:00. SO PLEASE JUST MUTE YOURSELF AND WE'LL SEE YOU BACK IN 10 MINUTES. >>WELCOME BACK FROM THE BREAK, EVERYONE. WE'LL PROCEED NOW WITH THE BUDGET REPORT AND BY OUR BUDGET OFFICER ON Mr. ERIC WILLIAMS AND THE BUDGET SLIDES ARE IN THE OPEN SESSION BOOK MARKS AND THE IN THE CURRENT COUNCIL TAB AND IN THE NIH ECB SO IF YOU WOULD LIKE TO HAVE ACCESS TO THEM. ERIC, WELCOME. >> GOOD AFTERNOON, EVERYBODY. AND I'M HAPPY TO GIVE A QUICK UPDATE ON WHERE OUR BUDGET STANDS FOR FISCAL YEAR '22. THIS SLICE SHOWS A COMPARISON OUR ALLOCATIONS FOR OUR FISCAL YEAR 2021 AGAINST 2022. I HAVE TO NOTE EVERY TIME THAT THIS IS NOT THE MOST UP-TO-DATE. I CAN ONLY PRESENT INFORMATION THAT'S BEEN PRESENTED TO CONGRESS AND SO THIS IS WHERE WE STOOD AT THE BEGINNING OF THE FOURTH QUARTER AND SOME OF THE NUMBERS THAT WE HAVE PROVIDED THE CONGRESS HAVE SHIFTED A LITTLE BIT AND I HAVE HIGHLIGHTED THOSE IN RED AND GREEN SO AS YOU CAN SEE HERE, OUR NON COMPETING NUMBERS WILL GO DOWN A LITTLE BIT. THE COUNT ISN'T GOING DOWN MUCH BUT THE AMOUNTS WILL BE GOING DOWN AND IT HAS TO DO WITH ACCOUNTING AND CO FUNDING WE'RE RECEIVING AND MAYBE SOME OF THESE GRANTS WERE AT CARING BALANCES AND LESS FUNDING THAT YEAR AND WE CAN SEE A REDUCTION IN THE RND CONTRACT LINE BECAUSE WE HAVE A SET ASIDE IN THERE FOR POTENTIAL SECRETARY TRANSFERS THAT IS AN AUTHORITY OF THE SECRETARY OF HHS TO PULL RESOURCES FROM EACH INSTITUTE AND IT DOESN'T APPEAR THAT MIGHT HAPPEN THIS YEAR SO I'M ANTICIPATING WE'LL PULL FUNDS OUT OF THERE AND OUR RMS COUNT JUST A LITTLE BIT AND IT WILL COME BACK FROM THERE TOO AND BECAUSE WE HAVE TO SPEND AS CLOSE TO SORE AS POSSIBLE. THESE RESOURCE ALSO GO INTO OTHER AREAS AND WE WILL SEE INCREASES IN OUR ADMINISTRATIVE SUPPLEMENTS AND MOST OF THOSE ARE DIVERSITY SUPPLEMENTS THAT WE'LL SEE INCREASE WE WILL HAVE A HIGHER RPG LINE THIS YEAR LAN YACHTER AND WE'LL SEE GROWTH THERE AS WELL AND IN OTHER RESEARCH THERE ARE PROGRAMS THAT WERE ADDING SOME FUNDS TO SO WE'LL SEE SOME GROWTH THERE AS WELL. CAN I HAVE THE NEXT SLIDE, PLEASE. AND JUST PROJECTING OUT WHAT THE FISCAL YEAR 2023 BUDGET LOOKS LIKE, RIGHT NOW WE HAVE RECEIVED MARK-UPS FROM THE HOUSE AND SENATE AND THEY'RE BOTH LOOKING AT A 3% INCREASE OVER OUR 2022 ENACTED AMOUNT. THE PRESIDENT'S BUDGET IS A LITTLE BIT LOW. WE HAD AN EXTENDED CONTINUUM RESOLUTION TO START THIS YEAR WHILE WE WERE PREPARING THE PRESIDENT'S BUDGET AND AS A RESULT OF THE CONTINUING RESOLUTION BEING SO LOW, THE PRESIDENT'S BUDGET FOR FISCAL YEAR 2023, IT SAYS REQUEST FOR 2023 IS ALSO PRETTY LOW AND I ANTICIPATE THAT THAT NUMBER IS NOT GOING TO WEIGH TOO HEAVILY IN WHAT WE'RE GOING TO SEE WHEN OUR 2023 BUDGET IS FINALLY APPROVED. I'M ANTICIPATING IT'S PROBABLY GOING TO BE CLOSER TO WHERE THE HOUSE AND THE SENATE ARE. ARE THERE ANY QUESTIONS? THANK YOU. SO NEXT ON THE AGENDA IS THE REPORT OF THE DIVISION OF THE SCIENTIFIC PROGRAMS AND CENTER COOPER. >> THANK YOU, DEB. GOOD AFTERNOON, EVERYONE. IN ADDITION TO MY ROLE AS DEPUTY DIRECTOR OF NIDCD I'M THE DIVISION DIRECTOR OF DSP THAT'S THE DIVISION OF SCIENTIFIC PROGRAMS WHICH IS THE HOME OF OUR PROGRAM OFFICERS. I HAVE JUST A VERY BRIEF REPORT BECAUSE I WANT TO SHARE WITH YOU BRIEFLY SOME EXCITING NEWS ABOUT NEW STAFF MEMBERS AND THEY HAVE JOINED OUR DIVISION. I WILL START WITH THIS SLIDE AND WHEN I'M DONE OUR NEW FOLKS WILL TURN OUR CAMERAS OFF SO YOU CAN MEET THEM. Ms. TANGY JOHNSON JOINED THE DSP IN APRIL AS A PROGRAM ASSISTANT AND SHE SPLITS HER TIME SUPPORTING DSP AND OUR ADMINISTRATIVE MANAGEMENT BRANCH. SHE SERVED AS A VETERAN SERVICE LIAISON AND ADMINISTRATOR AT A LOCAL SCHOOL. SHE IS PROVED HERSELF TO BE INVALUABLE SINCE APRIL AND WE WELCOME HER. Dr. HOLLY STORKEL JOINED DSP THIS MONTH AS A PROGRAM OFFICER FOR THE LANGUAGE PROGRAM. SHE'S A SPEECH LANGUAGE PATHOLOGIST WHO COMES FROM US FROM THE UNIVERSITY OF KANSAS IN THE DEPARTMENT OF SPEECH, LANGUAGE, HEARING, SCIENCES AND DISORDERS AND Dr. STORKEL BRINGS A HEALTH OF EXPERIENCE AS A NIDCD RESEARCHER IN LANGUAGE FOR MANY YEARS BUT ALSO A GRANT REVIEWERS AND Dr. JEAN VERHEYDEN JOINED AS A MEDICAL OFFICER IN THE CLINICAL TRIALS PROGRAM AND SHE'S HAS MANY YEARS OF PRACTICE IN OREGON AND SHE WILL WORK WITH OUR CLINICAL TRIALS TEAM WHICH IS LED BY Dr. TREN LEE. IF YOU CAN PUT YOUR CAMERAS ON AND SAY HI SO YOU WILL BE SPOTLIGHTED AT THE TOP OF THE SCREEN THAT WOULD BE GREAT. >> HELLO, EVERYONE. >> SEE JEAN, HOLLY, SAY HI AGAIN. >> HI, THERE. CAN YOU SEE ME NOW? >> THERE'S HOLLY. OK. AND TANGY. NOT SURE, OK. TANGI HAS BEEN HAVING VEHICLE CHALLENGES SO I'M NOT SURE IF SHE'S ON. THANK YOU. TANGI. OK! NOW THERE YOU ARE. CAN YOU SAY HI? >> HELLO! >> THANK YOU. THANK YOU, THAT'S IT. I THINK WE MOVE ON TO BECKY. >> THAT'S RIGHT. WELCOME BECKY FOR THE REPORT OF THE DIVISION OF THE EXTRAMURAL ACTIVITIES. >> Dr. Becky Wagenaar-Miller: C? SO, I JUST WANT TO BEGIN TODAY BY ALSO INTRODUCING NEW STAFF MEMBER SO Ms. TANYA HOLMES JOINS DEA AS THE SCIENTIFIC REVIEW BRANCH AS THE STAFF ASSISTANT AND SHE'S RETURNING TO NIDCD AFTER A BRIEF PERIOD IN THE NATIONAL LIBRARY OF MEDICINE. SHE'S BEEN A GREAT AS SET MANAGING THE LOGISTICS OF THE PEER REVIEW MEETINGS SO A BIG WELCOME TO TAN Y I JUST WANT TO GO OVER A FEW UPDATES ON NIH POLICIES AND EVENTS THAT MIGHT BE OF INTEREST TO YOU. SO, AS HEARD EARLIER, IN THIS SESSION, FROM Dr. TUCCI AND FROM OUR LAST MEETING, NIH HAS PUBLISHED AN UPDATED POLICY ON DATA MANAGEMENT AND SHARING WHICH EXTENDS THE LONGSTANDING DATA SHARING EXPECTATION AND RAISES THE DEPTH OF DATA SHARING SO THIS IS A BIG, IMPORTANT CHANGE AND I ENCOURAGE YOU TO CHECK OUT THE NIH WEBSITE AND FOR USEFUL INFORMATION LINKED TO WEBINARS AND HOPE AND PLANNING AND BUDGETING FOR DATA MANAGEMENT AND SHARING AND THERE'S EVEN AN OPTIONAL DATA MANAGEMENT AND SHARING PLAN FORMAT PAGE ON THE WEBSITE. I ALSO WANTED TO LET YOU KNOW THAT NIH IS EXTENDING THE PERIOD FOR DELAYED ENFORCEMENT FOR RESULTS AND RESULTS ACCORDING OF BASIC EXPERIMENTAL STUDIES WITH HUMAN PARTICIPANTS FOR BEST TRIAL THROUGH SEPTEMBER 24th, 2024 OUTLINED AND NOTED OD22-205. SO, IF YOU ARE AREN'T FAMILIAR IT MEETS THE CLINICAL TRIAL AND THE DEFINITION OF BASIC RESEARCH, AND THIS DELAY ONLY APPLIES TO STUDIES SUBMITTED TO FUNDING OPPORTUNITIES WITH THE DESIGNATION 6 BASIC EXPERIMENTAL STUDIES OF HUMANS. AND THE REASON NIH IS DOING THIS BECAUSE THEY RECOGNIZE THAT PURPORTING RESULTING IN CLINICAL TRIAL.GOV IS A CHALLENGE FOR SOME PROJECTS. AND NIH IS CONTINUING TO WORK WITH THE COMMUNITY TO EXPLORE SOLUTIONS FACILITATE THE DISSEMINATION OF THE INFORMATION IN WAYS THAT ARE USEFUL TO THE OTHERLY SEARCHERS AND MEMBER OF THE PUBLIC. ALSO MAINTAINING THE COMMITMENT TO STEWARDSHIP AND INCREASING TRANSPARENCY OF STUDIES WITH HUMANS. NIH EXPECT THE REGISTRATION AND RESULTS REPORTING FOR THE STUDIES BOTH ADDITIONAL FLEXIBILITY TO REGISTER AND REPORT THEM IN AN ALTERNATIVE PUBLICLY AVAILABLE PLATFORM. I WANTED TO ENCOURAGE EVERYONE TO REGISTER FOR AND ATTEND THE REVAMPED VIRTUAL NIH GRANT CONFERENCE IN PRE-CON EVENT. THIS REPLACES WHAT WAS THE NIH REGIONAL SEMINAR AND THIS NEW FORMAT HAS A TWO-DAY CONFERENCE THAT TAKES PLACE THIS YEAR IT WILL BE NOVEMBER 1st AND 2n 2nd. AND THERE'S NUMEROUS PRE CON EVENTS FROM AUGUST TO JANUARY. THIS IS A FREE EVENT HOSTED BY NIH AND HAS USEFUL INFORMATION FOR ALL LEVELS OF ADMINISTRATORS IT YOU CAN SEE THE WIDE RANGE OF TAKING PLACE EARLY CAREER FUNDING OPPORTUNITIES TO COLLABORATIONS TO HUMAN SUBJECTS RESEARCH. AND THESE SESSIONS WILL BErdED AND MADE AVAILABLE ON THE NIH GRANTS AND WEBSITE AS WELL AS ON NIH'S GRANTS YouTube CHANNEL. AND FINALLY DURING THE TWO-DAY CONFERENCE ON NOVEMBER 1 AND 2, MANY EXHIBIT HALL BOOTHS WILL OFFER OPPORTUNITIES FOR 20 MINUTES CONVERSATIONS WITH NIH EXPERTS. STOP BY OUR BOOTH TO VISIT WITH STAFF INCLUDING REPRESENTATIVES FROM THE PROGRAM OFFICERS AND SCIENTIFIC BRANCH AND BRANCH MANAGEMENT SPECIALISTS. AND I MENTIONED AT OUR MAY MEETING THAT WE'RE LAUNCHED A WEB FORM TO ALLOW INDIVIDUALS TO SELF-NOMINATE TO SERVE AS REVIEWERS FOR NIDCD PEER REVIEW MEETINGS AND THERE ARE LINKS MULTIPLE PLACES ON OUR WEBSITE FOR THIS AND WE HAVE RECEIVED A GREAT RESPONSE TO THE CALL AND I WANT TO KEEP ENCOURAGING YOU TO REACH OUT TO INDIVIDUALS WHO MIGHT BE INTERESTED WHO HAVE NOT SUBMITTED A FORM TO LET US KNOW OF THIS INTEREST IN SERVING AS THE REVIEWER. THE SCIENTIFIC REVIEW OFFICERS WILL REVIEW THE INFORMATION PROVIDED AND ANY REGISTRANTS THAT THEY WOULD ANY OTHER POTENTIAL REVIEWERS IN TERMS OF EXPERTISE AND EXPERIENCE. IT DOES NOT ENSURE A INDIVIDUAL WOULD BE ASKED TO REVIEW AND IT LET'S US EXPAND OUR POOL OF REVIEWERS. AS I LOOK BACK ON MY FIRST YEAR, I WANT TO THANK ALL THE STAFF OR DEA FOR THEIR HARD WORK AND MANAGEMENT OF THE COUNCIL AND COMMITMENTS AND THE GRANTS AND MONITORING THE COMPLIANCE AND IN THE PEER REVIEW. THEY'RE AN OUTSTANDING GROUP OF TALENTED AND COMMITTED INDIVIDUALS WHO WORK BEHIND THE SCENES TO ENSURE WE FUND THE BEST RESEARCH AND RESEARCH TRAINING INTO PREVENT AND PROMOTE SELF-COMMUNICATIONS. SO, THANK YOU, EVERYBODY. >> Dr. Debara Tucci: THANK YOU, BECKY. I DIDN'T REALIZE THIS WAS YOUR ONE-YEAR ANNIVERSARY BUT IT'S TRUE. IT'S BEEN A WHIRLWIND YEAR. I REALLY APPRECIATE ALL OF YOUR WORK. >> THANK YOU. >> Dr. Debara Tucci: ALL RIGHT. I WOULD LIKE TO CONCLUDE THE MEETING THANKING OUR RETIRING COUNCIL MEMBERS AND Mr. RICHARD EINHORN, HILLMAN AND MORTON FOR YOUR SERVICE. YOUR THOUGHTFUL ADVICE HAS BEEN INVALUABLE TO ME AND ALL OF THE NIDCD STAFF OVER THE PAST FOUR YEARS. ON BEHALF OF THE Dr. LARRY TABAK WHO HAS BEEN PERFORMING THE DUTIES OF THE NIH DIRECTOR AND THE NIDCD STAFF I'D LIKE TO EXPRESS OUR GRATITUDE FOR YOUR TIME AND EFFORTS WHILE SERVING AS A MEMBER OF THE NATIONAL DEAFNESS AND OTHER COMMUNICATIONS DISORDERS ADVISORY COUNCIL. SO NORMALLY, WE WOULD BE HANDING YOU CERTIFICATES IN RECOGNITION OF YOUR SER EXPRESS AS A SMALL TOKEN OF OUR APPRECIATION BUT WE WILL HAVE TO MAIL THEM TO YOU. AS IT WAS TRADITION RETIRING AND INVITED TO PROVIDING WITH ADVISER OBSERVATIONS GLEAN FROM THEIR TIME ON COUNCIL. SO Dr. HILLMAN COULD NOT BE WITH US FOR THE OPEN SESSION TODAY, BUT I WOULD LIKE TO INVITE Mr. EINHORN AND Dr. MORTON TO MAKE ANY COMMENTS. SO FIRST, RICHARD, DO YOU HAVE ANY FINAL WORDS FOR US? >> I DON'T KNOW IF I HAVE ANY ADVICE, I JUST WANT TO SAY IT'S BEEN A GREAT PLEASURE TO BE PART OF THIS COUNCIL. I'VE LEARNED A GREAT DEAL AND ENJOYED GETTING TO KNOW SOME OF MY COUNCIL MEMBERS. LIKE MANY MEMBERS OF THE LAY PUBLIC, MY KNOWLEDGE AND UNDERSTANDING OF NIH WAS PRETTY LIMITED BEFORE Dr. CRAIG JORDAN GAVE ME AN ORIENTATION SPEECH JUST BEFORE MY FIRST MEETING AND I WAS REALLY IMPRESSED. OVER THE PAST FEW YEARS, MY RESPECT FOR THE PROFESSIONALISM AND PASSION FOR HEARING HEALTH FROM THE MEMBERS OF NIDCD HAS REALLY EXPONENTIALLY INCREASED. AS I SAID MANY TIMES, NIDCD IS A PERFECT EXAMPLE OF HOW GOVERNMENT CAN WORK FOR THE BENEFIT OF ALL AND WORK REALLY WELL. SO I JUST WANT TO THANK YOU ALL, THANK YOU DEBRA, THANK EVERYBODY ELSE THAT IS REALLY BEEN A GREAT PLEASURE TO BE PART OF THIS. >> Dr. Debara Tucci: THANK YOU, RICHARD. CYNTHIA -- >> I WANT TO SAY THANKS ALSO AND SEEING RICHARD HERE BEFORE ME, REMINDS ME THAT WE HAD A STANDING DATE FOR BREAKFAST AT THE HOTEL FROM THE VERY FIRST MEETING. AND SO, NOT ONLY DO YOU GET WONDERFUL SCIENTIFIC COLLEAGUES, YOU GET REALLY GOOD FRIENDS ALSO FROM SERVING ON THE COUNCIL. RICHARD, I THINK I'LL HAVE TO MEET YOU IN MANHATTAN AT SOME POINT, RIGHT? WE'LL KEEP THIS UP. I'M NOT SURE WHAT WOULD GO FOR BREAKFAST BUT ANYWAY, WE CAN FIGURE THAT OUT. SO, WHEN I WAS THINKING ABOUT -- WHEN I SAW MY NAME ON THIS SCHEDULE I WAS LIKE OH, YEAH, I HAVE TO SAY SOMETHING. SO, I WANT TO TELL YOU THE SIX Ps OF THANK YOU. SO, THANK YOU TO ALL FOR YOUR PROFESSIONALISM, YOUR PATIENCE, WITH THE PASSWORDS, AND YOUR PERSISTENCE. AND I THINK WE'RE ALL DEDICATED TO SEEING THE NIH MISSION THRIVE AND I REALIZE NEXT WEEK IS THE RALLY FOR MEDICAL RESEARCH, SO I HOCH THAT WE ALL ADVOCATE WHERE WE CAN FOR THE NIH AND I GUESS JUST LASTLY, TO STEAL FROM MARY POPPINS, I THINK YOU ARE PRACTICALLY PERFECT IN EVERY WAY. SO, I'LL DEFINITELY MISS SEEING YOU. >> Dr. Debara Tucci: WE WILL MISS BOTH OF YOU. THANK YOU BOTH SO MUCH FOR YOUR REALLY KIND COMMENTS AND FOR ALL OF YOUR SERVICE. SO, I THINK THAT WRAPS UP THE MEETING FOR TODAY. WE HAVE A REALLY INTERESTING SCHEDULE FOR TOMORROW. FOCUSING ON THE INTRAMURAL PROGRAM AND A PRESENTATION BY Dr. JEFF GINGSBERG FOR THE ALL OF US RESEARCH PROGRAM SO I'M LOOKING FORWARD TO HEARING ALL OF THOSE PRESENTATIONS AND LOOK FORWARD TO SEEING YOU AT THAT TIME. HAVE A GREAT AFTERNOON AND EVENING AND SEE YOU AGAIN TOMORROW. BYE-BYE.