>> HELLO, EVERYONE. I'M FRANCIS COLLINS, DIRECTOR OF NATIONAL INSTITUTES OF HEALTH AND WELCOME TO A 90 MINUTE DISCUSSION ABOUT WHAT WE MIGHT WANT TO BE THINKING ABOUT WITH REGARD TO DIAGNOSTICS AND UNIVERSITIES. WE HAVE WITH US A REMARKABLE GROUP OF PANELISTS WHO HAVE ALL BEEN WRESTLING WITH COVID-19 AS WE ALL HAVE BEEN AND WE WANT VERY MUCH TO SEE WHAT KINDS OF THINGS WE COULD ALL LEARN FROM EACH OTHER IN THIS EXCEPTIONALLY UNUSUAL YEAR. --PRETTY MUCH 247 FOR THE LAST 18 WEEKS, HAD THIS WHOLE QUESTION OF HOW WE CAN SPEED UP THE AVAILABILITY OF DIAGNOSTIC TESTING AND HOW TO MAKE IT MORE READILY ACCESSIBLE AT POINT OF CARE HAS BEEN AN OBSESSION ALONG WITH OTHER OBSESSIONS THAT RELATE TO THERAPEUTICS AND VACCINES AND I GUESS YOU CAN THINK OF THAT AS THE 3-LEGGED STOOL OF WHAT WE NEED TO GET PAST THIS AND BACK INTO SOMETHING YOU MIGHT CALL AN APPROXIMATION TO NORMAL LIFE. AND WE STILL ARE NOT THERE AS YOU ALL KNOW, WE FACE AT THE PRESENT TIME A CIRCUMSTANCE WHERE COVID-19 IS ACTUALLY IN A VERY SERIOUS PLACE IN THE SOUTHEAST AND THE WEST NOW WITH MORE THAN 4 MILLION CASES DIAGNOSED IN THE U.S. COMING UP AROUND 70,000 EVERY DAY AS WELL AS SADLY TO SEE NOW THE UPTICK IN DEATHS EVERYDAY ALSO COMING TO THE POINT NOW WHERE WE'RE OVER A THOUSAND FOR THE LAST 3 DAYS. AND OF COURSE IN THE MIDST OF ALL THAT, EVERYBODY IS TRYING TO DO WHAT THEY CAN IN ORDER TO ATTEND TO CRITICAL ISSUES ABOUT OUR SOCIETY AND PARTICULARLY ABOUT SUCH THINGS AS EDUCATION WHICH OUR PANELISTS ARE DEEPLY ENGAGED IN AND MANY UNIVERSITIES STRUGGLING TO TRY TO UNDERSTAND WHAT WOULD MAKE THE MOST SENSE IN TERMS OF THE COMING SEMESTER BOG IN TERMS OF TRYING TO ADVANCE THE CAUSE OF EDUCATION, GRADUATES, UNDERGRADUATES, FACULTY BUT ALSO TO OPTIMIZE THE CHANCE OF KEEPING EVERYBODY SAFE, RECOGNIZING THIS IS A SERIOUSLY DANGEROUS SITUATION IN SOME MANY INSTANCES. SO WE WITHIN NIH AND OUR COLLEAGUES, PARTICULARLY IN THE OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH WHO YOU ARE ABOUT TO HEAR FROM, AS WELL AS COLLEAGUES AT CMS, FDA, CDC HAVE BEEN WORK NOTHING WHATEVER WAYS WE CAN CREATIVELY TO TRY TO ASSESS THAT PROBLEM AND COME UP WITH RESOURCES TO MOVE THE TESTING CAPABILITIES FORWARD. AND I THINK IT'S FAIR TO SAY A GREAT DEAL OF PROGRESS HAS BEEN MADE. ADMIRAL GIROIR CAN TELL YOU MORE ABOUT THAT, WITH OVER SEVERAL THOUSAND TESTS IT THE U.S., ALTHOUGH WE FACE A TURN AROUND IN THE TESTS RESULTS BEING LESS ACTIONABLE THAN WE WANT THEM TO BE. AND MANY UNIVERSITIES ARE TRYING TO COME UP WITH A STRATEGY WHERE THEY COULD USE IN FACT PROVIDE A REGULAR TESTING CAPACITY TO STUDENTS AND FACULTY IN ORDER TO MAXIMIZE THE CHANCE OF SAFETY. AND YET, THERE'S NO EASY OBVIOUS SOLUTION OF HOW TO DO THAT. SO WE'VE BEEN TALKING ABOUT THIS AMONGST OURSELVES, A GROUP OF US THAT ARE FOCUSED PARTICULARLY ON TESTING THAT BRETT CONVENES--ADMIRAL GIROIR CONVENES ONCE A WEEK WHICH INCLUDES NIH, BARTA, THAT HAS A LOT OF RESOURCES WITH SCALE OF TESTING AND THE DEPARTMENT OF DEFENSE AS WELL, AND IT SEEMS TO US WHEN WE MET LAST STUDY THAT IT MIGHT BE TIME TO TRY TO GET A BROADER SENSE FROM ACADEMIC INSTITUTIONS ABOUT WHERE THEY ARE AND WHAT THEIR NEEDS MIGHT BE. ALL OF US HAVE HAD INDIVIDUAL CONVERSATIONS WITH VARIOUS INSTITUTIONS BUT WE NEVER QUITE TRIED TO PUT IT TOGETHER LIKE THIS. SO WE DID REACH OUT TO RYE TO UNDERSTAND WHAT KIND OF INTEREST WOULD BE THERE, CARRIE REACHED OUT TO APLU TO AAU, TO AAMC, AND CERTAINLY FOUND THAT THERE WAS A LOT OF INTEREST IN HAVING THIS KIND OF A CONVERSATION AND THAT IN FACT THERE MIGHT BE THOUSANDS OF LEADERSHIP FROM PRESIDENTS ON DOWN THAT MIGHT WANT TO TAKE PART. IN ORDER TO MAKE IT A CONVERSATION WHERE WE COULD ACTUALLY MANAGE THE NUMBERS OF POINTS OF VIEW, WE DECIDED TO TRY TO PICK A PANEL OF DISTINGUISHED FOLKS AND THEY ARE NOW WITH US AND THEY WILL TALK FROM THEIR UNIVERSITY'S PERSPECTIVE ABOUT WHERE THINGS ARE. SO THAT'S WHAT WE'RE GOING TO TRY TO DO OVER THE COURSE OF THIS HOUR AND A HALF. TO KICK THIS OFF, THOUGH, I WOULD LIKE TO NOW INTRODUCE TO YOU SOMEBODY WHO I HAVE LEARNED TO HAVE RESPECT FOR AND WHO HAS BEEN A WONDERFUL ALLY IN THIS EFFORT TO ADDRESS COVID-19 ACROSS MANY DIFFERENT AREAS BUT ESPECIALLY IN THE AREA OF DIAGNOSTIC TESTING. ADIRBAL GIROIR IS A PEDIATRIC INTENSIVE CARE EXPERT. HE BRINGS ALL OF THAT EXPERIENCE AS WELL AS KNOWLEDGE OF PUBLIC HEALTH AND AN INTRICATE KNOWLEDGE HE DEVELOPED OVER THE COURSE OF QUITE A FEW MONTHS NOW ABOUT THE WHOLE DIAGNOSTIC TESTING ARENA AND WAYS IN WHICH WE COULD ACCELERATE ACCESS TO TESTS FOR THOSE WHO NEED IT. SO I WILL, WITHOUT FURTHER ADO, TURN THIS OVER TO ADMIRAL GIROIR. SHORTLY AFTER THAT WE WILL HEAR FROM THE ADMINISTRATOR OF CMS, SEEMA VERMA BECAUSE I THOUGHT YOU MIGHT ALSO BENEFIT FROM COMMENTS SHE MIGHT MAKE ABOUT THIS ISSUE-- >> IT'S GREAT TO BE WITH ALL OF YOU TODAY. I HAD A FORMAL CALL WITH THE LEADERSHIP OF MULTIPLE UNIVERSITY ORGANIZATIONS, LAND GRANTS ISSUES THE PRIVATES, THE INDEPENDENTS, ET CETERA THIS IS MUCH BETTER BECAUSE WE GET TO HAVE A LITTLE FACE-TO-FACE ONE-ON-ONE AND REALLY UNDERSTAND AND GET TO LISTEN MUCH MORE FROM EXPERTS IN YOUR ARENA. ALSO ON THE LINE WITH ME TODAY IS DR. TAMMY BECKHAM, IN MY OFFICE, HER DAY JOB IS RUNNING THE OFFICE OF INFECTIOUS DISEASE AND HIV POLICY BUT SHE LIKE I HAVE BEEN 24/7 SINCE MARCH 12th RUNNING TESTING AND DIAGNOSTICS AND TRYING TO BUILD THE ECOSYSTEM. SHE'S VERY TECHNICAL IN THIS AREA AND CAN ALSO ANSWER SOME QUESTIONS. SO I JUST WANT TO MAKE A FEW COMMENTS AND YOU CAN STEER ME WHEREVER YOU YOU WANT TO GO IN TERMS OF QUESTIONS AND ANSWERS AND I WILL ASSUME HAVE YOU A PRETTY GOOD KNOWLEDGE OF THE OVERALL CDC GUIDELINES FOR INSTITUTIONS OF HIGHER EDUCATION OF COURSE THAT IT IS NOT RECOMMENDED TO TEST EVERYONE BEFORE THEY GO BACK ON CAMPUS AND IT IS CERTAINLY NOT A SUBSTITUTE FOR MITIGATION STEPS THAT YOU WILL UNDOUBTEDLY HAVE WITH YOUR STUDENTS IN TERMS OF PHYSICAL DISTANCING, MASK WEARING AND HYGIENE. THE NUMBER OF THE NEGATIVE TEST IS ONLY NEGATIVE FOR THAT MOMENT IN TIME. IT COULD BE POSITIVE IN 3 HOURS OR ANOTHER DAY OR 2 DAYS AND PARTICULARLY AMONG ASYMPTOMATIC INDIVIDUALS, I KNOW WE TEST THEM REGULARLY BUT THERE IS LITERALLY ONLY 1 SEEM TO BE AUTHORIZED LABORATORY BASED TEST FOR ASYMPTOMATIC INDIVIDUALS SO WE'RE NOT EXACTLY SURE THE PERFORMANCE EVEN IF YOU DO TEST THEM. SO THERE ARE A LOT OF CAVEATS HERE. SO IN A UNIVERSITY ENVIRONMENT, WHO SHOULD YOU TEST? WHO REALLY DOES NEED A TEST? AND I'M GOING TO PROBABLY TALK ABOUT THE UNQUESTIONABLE 1S ACCORDING TO GUIDELINES AND COMMON SENSE. NUMBER 1 IF THERE'S A PERSON WHO'S SYMPTOMATIC WITH ANY OF THE SYMPTOMS THAT CERTAINLY COULD BE CONSISTENT WITH COVID-19, THAT PERSON NEEDS A DIAGNOSTIC TEST, MEANING A TEST IN A CLEAN CERTIFIED ENVIRONMENT, ENVIRONMENT ON A MACHINE THAT HAS AN AUTHORIZATION FOR THAT TEST, AN FDA AUTHORIZED TEST THAT IS GOING THROUGH THE NORMAL PROCESSES. WHO ELSE NEEDS A TEST? WELL, WHO NEEDS A DIAGNOSTIC TEST? PEOPLE WHO ARE IN CLOSE CONTACT UNDER A CONTACT TRACING SITUATION. IF YOU HAVE A DORM ROOMMATE WHO IS COVID POSITIVE, CLEARLY THAT PERSON WHO IS SLEEPING WITH THE SAME ROOM WITH YOU, CLOSE CONTACT AND DESERVES TO HAVE A TEST, NOT EVERYONE ON A CONTACT TRACE ABSOLUTELY NEEDS A TEST BUT THOSE WHO ARE IN CLOSE CONTACT BY YOUR CONTACT TRACERS SHOULD HAVE A DIAGNOSTIC AUTHORIZED TEST IN A CLEAR ENVIRONMENT. IT IS ALSO SUGGESTED TO TEST THOSE FOR DIAGNOSTIC TEST WHO MAY HAVE BEEN IN A VERY HIGH RISK ENVIRONMENT. FOR EXAMPLE, IN THE CONTACT TRACING BUT LET'S TAKE IT FOR A MEAT PACKING PLANT OR A FRATERNITY PARTY OR SOMETHING LIKE THAT WHERE A LOT OF PEOPLE WERE SORT OF IN THE SAME SPACE IN ENGAGING IN RISKY BEHAVIOR IN TERMS OF THE COVID, MEANING CLOSE CONTACT, NOT FACE MASK WEARING AND PARTICULARLY INDOOR SITUATIONS, INDOOR BARS REALLY HORRIBLE FOR TRANSMISSION, WE SEE AS MUCH AS 50, 60, 70% OF CASES IN THE SUN BELT WHEN THIS STARTED OUT DIRECTLY TRACED TO INDOOR BAR ACTIVITY. SO ALL THOSE REALLY DESERVE A DIAGNOSTIC TEST. LET ME EMPHASIZE THAT IF A PURPOSE IS POSITIVE, IT IS NOT RECOMMENDED TO DO A CONFIRMATORY TEST OF THEM BEING NEGATIVE. WE JUST ELIMINATED THAT FROM THE CDC GUIDELINES, THIS IS REALLY A REMNANT OF THE DAYS WHEN MY PUBLIC HEALTH SERVICE OFFICER AND I WERE REPATRIATING PEOPLE OFF THE DIAMOND PRINCESS AND THEY WERE IN MULTIPLE AIR BASES AND JOINT BASES ACROSS THE COUNTRY. THE CURRENT GUIDE LINES ARE PRETTY CLEAR. IF YOU ARE 10 DAYS FROM SYMPTOM ONSET, A MINIMUM OF 10 DAYS FROM SYMPTOM ONSET AND AT LEAST 24 HOURS A-FIBRILE, WITH OTHER SYMPTOMS IMPROVING, YOU ARE FREE TO ASSOCIATE WITHOUT A CONFIRMATORY NEGATIVE TEST. NUMBER 1, HAVING CONFIRMATORY NEGATIVE TEST IS A DRAIN ON THE TESTING SYSTEM THAT IS NOT NEEDED, NUMBER 2 THIS AUDIENCE CLEARLY KNOWS THAT YOU'RE HIGHLY SENSITIVE PC R TEST, ESPECIALLY AT HIGH CYCLE TIMES CAN BE POSITIVE LONG AFTER YOU ARE NO LONGER INFECTIOUS. SO IT IS NOT UNCOMMON TO HAVE PEOPLE WITH CT-VALUES OF 35, 37, 38, WHO ARE POSITIVE BY THE LABORATORY DIAGNOSTIC TEST--AND I WILL GIVE YOU THE EXCEPTION IF YOU DO HAVE A PERSON WHO'S CRITICAL ILL IN THE HOSPITAL OR OTHERWISE IMMUNOSUPPRESSED, VIRAL SHEDDING HAS BEEN DOCUMENTS SO THOSE INDIVIDUALS, THOSE CLINICAL CRITERIA REALLY DON'T GO, YOU HAVE TO EXERT CAUTION BUT TAKEN--THEY PROBABLY WILL BE A CLINICAL AND HOSPITAL DECISION FOR YOU. SO LET'S TALK ABOUT SURVEILLANCE, AND I THINK HERE'S OPPORTUNITIES HERE AND GIVE ME A COUPLE MINUTES AND I WILL WIND UP AND FINISH UP. SO SURVEILLANCE TESTING IS REALLY DEFINED AS THOSE TESTS ABOUT WHICH YOU'RE NOT MAKING A SPECIFIC DECISION ABOUT A SPECIFIC INDIVIDUAL PERSON. YOU COULDN'T DO A TEST ON AN INDIVIDUAL PERSON AND GIVE THEM A DIAGNOSIS, THAT IS NOT SURVEILLANCE. SO YOU ARE NOT MAKING A DECISION ABOUT THAT PERSON EXCEPT, AND THIS IS A VERY IMPORTANT CLARIFICATION BY THE FDA, THAT IF A PERSON IS POSITIVE IN A POOL OF SAMPLES THAT YOU USE FOR SURVEILLANCE, IT IS ABSOLUTELY LEGITIMATE TO REFER THOSE 4 OR 5 PEOPLE IN THE POOL TO A DIAGNOSTIC TEST. SO THIS DOESN'T HAVE TO BE AN ACADEMIC EXERCISE WHERE YOU'RE JUST DOING SURVEILLANCE TO SEE WHAT THE PREVALENCE OF ACTIVE INFECTION IN IS IN YOUR POPULATION. IF YOU HAVE A POOL OF OUR OR 5, THAT POOL IS POSITIVE, CAN YOU REFER EACH OF THOSE INTO THE DIAGNOSTIC SYSTEM FOR A REAL DIAGNOSTIC TEST. NO EUA IS NEEDED FOR SURVEILLANCE TESTING OF THIS SORT. SO ALTHOUGH THE ASSAYS THAT YOU USE WILL ALMOST UNDOUBTEDLY HAVE AN EUA, THE ISSUE IS AROUND POOLS. THERE IS ONLY 1 EUA CURRENT FOR POOLING, THAT'S THE LABORATORY DEVELOPED TEST DONE BY QUEST. THAT IS NOT THE EQUIVALENT OF SAYING THAT POOLING IS NOT SCIENTIFICALLY VALID, YOU CAN EITHER DO IT ON YOUR OWN INSTRUMENTS AND YOUR OWN ASSAYS OR THERE IS A VAST AMOUNT OF DATA THAT ARE CURRENTLY IN THE PROCESS OF BEING PUT OUT THAT POOLS OF 4 OR 5, NOT 8 OR 10, BUT IT LOOKS LIKE 4 OR 5 ON A GOOD LABORATORY INSTRUMENT IS HIGHLY SENSITIVE AND YOU'RE NOT GOING TO REALLY BE GETTING A HIGH FALSE-NEGATIVE RATE. SO AND I'LL PUT THIS IN CON-OPS, IN A SECOND BUT ADMINISTRATOR VERMA WILL ALSO TELL YOU AND I WON'T STEAL HER THUNDER IS THAT YOU MAY USE THESE TESTS IN A STRATEGY THAT IS NOT AUTHORIZED LIKE POOL NOTHING A NONCLEA ENVIRONMENT, MEANING CAN YOU DO THAT IN YOUR RESEARCH LABORATORIES. IT IS NOT A GOOD IDEA TO DO SURVEILLANCE USING THE DIAGNOSTIC SYSTEM LIKE SENDING IT TO QUEST OR LAB CORE OR EVEN YOUR HOSPITALS, NUMBER 1 THOSE TESTS GENERALLY COST 125 OR OR $150 TO DO SO IT IS VERY EXPENSIVE AND NUMBER 2, YOU'RE GOING TO HAVE DELAY. WE ARE WORKING ON OUR DELAYS. WE ARE DOING MUCH BETTER, YOU WILL SEE IMPROVEMENT NEXT WEEK WITH DELAYS BUT IF I ALWAYS OF A SUDDEN HAVE 5 OR 10 MILLION COLLEGE OR K-12 STUDENTS, THAT WILL CLOG UP THE SYSTEM AND I WILL QUITE HONESTLY DEPRIORITIZE THEM AND YOU'LL NEVER GET THOSE TESTS BACK BECAUSE I CANNOT HAVE THIS INTERFERING WITH THE DIAGNOSIS OF HOSPITALIZED PATIENTS WAITING FOR REMDESIVIR OR ANY OTHER PLASMA OR THERAPY OR PUBLIC CONTRACT TRACING. SO THIS IS SORT OF THE PROPOSITION, IF YOU WANT TO DO SURVEILLANCE, WE STILL HAVE TO TALK ABOUT WHAT PERCENT DO YOU WANT TO SURVEY? HOW DO YOU WANT TO DO IT? DO YOU DO RANDOM POPULATIONS? OR IS LIKE LSU OR SOUTHERNER COMBINING TO DO A SERIAL OPERATING GLOBALLYALATION, THEY'RE THE CANARYS IN THE COAL MINE BUT GENERATING REAMS OF DATA ABOUT VULNERABILITIES AND DATA AND EPIDEMIOLOGY AND HIGH RISK POPULATIONS YOU MAY HAVE IN YOUR UNIVERSITY. SO ALL THAT IS THERE. SO IF YOU WERE GOING TO PULL IN YOUR UNIVERSITIES AGAIN YOU COULD DO IT IN A RESEARCH LAB, LET ME JUST TELL YOU FOR THOSE LAB RATORRIANS, IF YOU ARE RUNNING A ROCHE, WE WON'T HAVE REAGENTS FOR YOU. IF YOU ARE RUNNING A PANTHER, WE WILL NOT HAVE REAGENTS FOR YOU. THERE WILL BE THERMOFICIAL REAGENTS THAT RUN ON THE ABI 7500, THE OLD WORKFORCE, THE FAST DX THAT ALL OF YOU HAVE. THERE ARE 3000 MACHINES OUT THERE, IF YOU DON'T KNOW YOU HAVE THEM, WE KNOW WHERE EVERY MACHINE IS AND WE KNOW WHAT A LOT OF THEM ARE DOING, SUCH AS THE INFORMATICS WORLD. IF YOU POOL OUT OF 4 OR 5 TO 1 WITH THE KINDS OF COSTS WE SEE, THIS GETS YOU DOWN TO ABOUT $2.50S PER TEST OF COURSE, PLUS YOUR LAB TIME, THAT'S A WHOLE LOT BETTER THAN $150 PER TEST AND IF YOUR POOL IS POSITIVE, THAT GOES INTO THE DIAGNOSTIC SYSTEM WHICH WOULD--SYSTEM WHERE YOU MIGHT HAVE POINT OF CARE MACHINE OR YOU MIGHT SEND THEM INTO THE TYPICAL PUBLIC HEALTH DIAGNOSTIC SYSTEM FOR A LABORATORY BASED TEST. LAST TECHNOLOGY TRANSFER I WILL JUST SAY IS POINT OF CARE IS CLEARLY THE GROWTH RATE ON JUST TO LET YOU KNOW I TOLD YOU ON LABORATORY TESTS, THERMOGENESISSA-FISHER WILL BE THE 1 WE HAVE EXCESS OF AND IT'S GOOD BECAUSE HAVE YOU THE PLATFORMS TO RUN IT. POINT OF CARE TEST PARTICULARLY ANTIGEN TESTS WILL BE IN HIGHER SUPPLY. THEY ARE BASICALLY 1 MOLECULAR CARE TEST THAT THEY DO NOW, IT'S AN ISOTHERMAL CYCLER TEST, IT IS VERY GOOD, VERY SENSITIVE. ABOUT 90% PROBABLY LIMITED SUPPLY ABOUT 1.2 MILLION PER MONTH WORLD WIDE THAT WE KEEP THEM ALL IN THE U.S. AND I BUY 40% OF THEM FOR THE U.S. GOVERNMENT TO DISTRIBUTE TO PUBLIC HEALTH LABS, THE INDIAN HEALTH SERVICE AND OTHER NEEDY POPULATIONS PARTICULARLY IN RURAL AREAS. THE ANTIGEN TEST BY QUIDEL, OR BD-VERITOR, WILL BE AVAILABLE IN 20 MILLIONS BY AUGUST AND MAYBE 20-MILLION PLUS IN OCTOBER, I AM PROVIDING INSTRUMENT AND POINT OF CARE TO EVERY SINGLE NURSING HOME IN THE COUNTRY BECAUSE THEY'RE HIGHLY VULNERABLE BUT THESE WILL BE AVAILABLE AND WOULD BE A REALLY GOOD CHOICE FOR YOUR STUDENT HEALTH SERVICES BECAUSE IT'S A 15 MINUTE TURN AROUND AND YOU CAN DACEY CHAIN AND DO ABOUT 20 PER HOUR, SO THIS IS REAL TECHNOLOGY RIGHT HERE, NOT DEPENDING ON THE RADX PROGRAMS WHICH MAY GIVE WHIZBANGS IN THE FUTURE BUT THIS IS HERE AND NOW. THERE MAY BE OTHER BREAKTHROUGHS ON SORT OF CARD BASED TECHNOLOGIES DURING THE OCTOBER TIME FRAME BUT THEY'RE NOT AUTHORIZED AND WE CAN'T SORT OF RECOMMEND THEM. SO WITH THAT I WILL STOP. HOPEFULLY THAT GAVE YOU AN OVERVIEW OF OUR THOUGHTS AND INSIDE KNOWLEDGE ABOUT WHAT THE MANUFACTURES PROJECTS ARE. I CAN'T WAIT TO HEAR THE DISCUSSION AND HAPPY TO ANSWER ANY QUESTIONS. >> ALL RIGHT, THAT WAS CLASSIC BRETT GIROIR, RAPID FIRE, FULL OF INFORMATION. HOPE YOU GOT ALL THAT DOWN BECAUSE THERE'S AN INCREDIBLE WEALTH THERE OF POINTS I HOPE CAME ACROSS FOR EVERYBODY TO CHEW ON AND WE WILL DISCUSS MORE IN THE PANEL. BUT NOW LET ME ASK ADMINISTRATOR SEEMA VERMA OF CMS TO JOIN THE CONVERSATION, I KNOW HOW BUSY YOU ARE THESE DAYS, REALLY APPRECIATE YOUR TAKING TIME TO COME AND SPEAK TO THIS GROUP. >> THANK YOU DR. COLLINS AND THANK YOU DR. GIROIR, LET ME FIRST JUST SAY THANK YOU FOR ALL OF YOUR EFFORTS AS A MOTHER OF A COLLEGE AGED STUDENTS, I KNOW THE KIDS ARE ANXIOUS TO GO BACK AND I THINK SOME OF THE PARENTS WANT THEM OUT OF THE HOUSE, TOO, SO WE APPRECIATE EVERYTHING YOU'RE DOING TO TRY TO GET KIDS BACK TO SCHOOL. A COUPLE THINGS I WANT TO JUST FOCUS ON AND BUILDING ON WHAT DR. GIROIR SAID IS THAT IF YOU ARE DOING SURVEILLANCE TESTING AND THAT'S KIND OF THE KEY WORD, THAT DOESN'T REQUIRE CLEA CERTIFICATION. OUR REGULATIONS AROUND CLEA REFER TO THOSE LABS THAT ARE DOING DIAGNOSTIC TESTING AND SO IF YOU'RE ACTUALLY GIVING RESULTS TO A PATIENT, THAT WOULD BE SOMETHING THAT WOULD REQUIRE YOU TO GO THROUGH CLEA CERTIFICATION. SO DEPENDING ON YOUR ARRANGEMENT, LET ME START WITH, IF YOU ARE PLANNING ON GIVING RESULTS TO YOUR STUDENTS, HOW THAT MIGHT WORK. YOU WOULD HAVE TO GO THROUGH CLEA CERTIFICATION BUT IF YOU HAVE A LAB ON CAMPUS, YOU KNOW YOU COULD ACTUALLY GO UNDER THEIR CERTIFICATE. WE'VE DONE ARRANGEMENTS WITH THE VETERINARIAN SCHOOLS IN SOME PARTS OF THE COUNTRY WHERE THEY WERE ABLE TO GO UNDER ANOTHER CLEA CERTIFICATE SO THOSE ARE SOME OPTIONS THAT ARE POSSIBLE AND WE'RE HAPPY TO WORK WITH YOU ON THAT IF YOU HAVE SOME QUESTIONS. THE SECOND AREA AS DR. GIROIR SAID IS IF YOU'RE DOING SURVEILLANCE TESTING AND DOING POOLING AND LET'S SAY YOU FIND A PERSON OR SAMPLES THAT HAVE A POSITIVE TEST, THEN YOU WOULD HAVE TO REPEAT THAT FOR THE GROUP, BUT THAT REPEAT WOULD HAVE TO BE AT A CLEA LAB AND THAT'S SORT OF THE RULE. SO AGAIN, IF YOU ARE DOING JUST SURVEILLANCE TESTING, YOU IDENTIFY A POSITIVE GROUP, THEN THAT WHOLE GROUP WOULD HAVE TO BE REFERRED TO A DIAGNOSTIC LAB, SO IT STILL CUTS DOWN ON THE AMOUNT OF TIME, THE COST OF THIS, AND ONLY THOSE FOLKS THAT HAVE A POSITIVE RESULT, BUT JUST--I JUST WANT TO MAKE SURE THAT WERE VERY CLEAR ON IF YOU'RE DOING IT IN THIS STYLE WITH SURVEILLANCE TESTING IN A NONCLEA LAB THAT WE CANNOT GIVE DIAGNOSTIC RESULTS TO PEOPLE AND THAT'S SORT OF THE BRIGHT LINE THERE. IF THERE'S ANY QUESTIONS, WE ARE HAPPY TO WORK WITH YOU, WE CAN MAKE MY STAFF AVAILABLE. WE'VE BEEN TALKING TO MANY UNIVERSITIES, AND I THINK THERE'S A LOT OF OPPORTUNITIES TO EXPAND YOUR TESTING INSIDE OUR CLEA REGULATIONS AND WE'VE PROVIDED FLEXIBILITY. ALL OF THESE ITEMS THAT I JUST REFERRED TO ARE POSTED ON OUR WEBSITE, THERE'S A FREQUENTLY ASKED QUESTIONS PAGE. WE THANK AND YOU ALL OF YOUR EFFORTS. THANK YOU DR. COLLINS. >> THANK YOU SEEMA, SEEMA AND BRETT 1 QUICK QUESTION BEFORE WE GO TO THE PANEL BECAUSE I IMAGINE PEOPLE MAY HAVE BEEN THINK BEING OTHER ALTERNATIVE APPROACHES. IF YOU ARE DOING SURVEILLANCE AS YOU JUST DESCRIBED IN A NONCLEA ENVIRONMENT AND YOU GET POOLING AND YOU GET A POSITIVE POOL. AND THEY'RE LIKE SOME PLACES WHERE WE STILL HAVE THE ORIGINAL SAMPLE AND WE COULD QUICKLY RUN THE COMPONENTS OF THAT POOL, THEN WE CAN FIGURE OUT WHICH 1 OF THEM WAS ACTUALLY RESPONSIBLE FOR THE POSITIVE AND THEN WE JUST REACH OUT TO THAT 1 PERSON AND SAY, YOU NEED TO GO AND GET YOURSELF CHECKED IN A CLEA LAB, IS THAT ALLOWABLE? >> THAT'S WOULD WORK BECAUSE YOU'RE NOT ACTUALLY GIVING RESULTS. YOU'RE STILL MAKING THE REFERRAL TO THAT PARTICULAR PERSON TO HAVE THE ACTUAL DIAGNOSIS FORMS IN THE CLEA LAB, SO THEY CAN REPEAT THAT BUT JUST SO LONG AS YOU ARE TELLING SOMEBODY YES, YOU'RE POSITIVE OR NEGATIVE, WE'RE JUST CONFIRMING YOU NEED TO HAVE A TEST IN A CLEA-CERTIFIED LAB. >> THANK YOU. THAT'S HELPFUL. >> WELL, GREAT. WE SHOULD MOVE NOW TO OUR DISTINGUISHED PANEL AND HEAR FROM EACH OF YOU, WE ASKED EACH OF THE FOLKS TO SPEAK FOR 3-5 MINUTES FROM THEIR PERSPECTIVE, WE HAVE EVERYTHING FROM FROM PROVOSTS, TO CHANCELLORS, AND WE HAVE A PARTICULAR ORDER, IT'S A BIT ALPHABETICAL BUT NOT QUITE. SO WITH THAT, AND I'M NOT GOING TO GIVE LONG FLOWERY INTRODUCTIONS. LET ME ASK OUR FIRST PANELIST DR. CARRY BYINGTON, VICE PRESIDENT OF UC HEALTH TO SHARE WITH US WHAT SHE THINKS WILL BE MOST HELPFUL IN THAT PANEL DISCUSSION, I GATHER THERE ARE AT LEAST 500 PEOPLE LISTENING TO THIS DISCUSSION USING THE VBRIC TECHNOLOGY WE HAVE SET UP IN ORDER FOR LOTS OF PEOPLE TO BE ABLE TO LISTEN, IT MAY BE OUT OF DATE, IT MAY BE MORE THAN THAT. SO HAVE YOU A BIG AUDIENCE, THANK YOU PANELISTS AND DR. BYINGTON, LET'S START WITH YOU. >> THANK YOU DR. COLLINS AND THANK YOU FOR THE OPPORTUNITY TO SHARE THE UNIVERSITY OF CALIFORNIA EXPERIENCE. I AM AN INFECTIOUS DISEASE PHYSICIAN AND HAVE BEEN LEADING THE EFFORTS FOR OUR RESUSMGZ ON THE UNIVERSITY OF CALIFORNIA CAMPUSES. THE UNIVERSITY OF CALIFORNIA INCLUDES 10 CAMPUSES, 6 ACADEMIC HEALTH CENTERS, 19 PROPELLED PROFESSIONAL SCHOOLS, 3 NATIONAL LABORATORIES AND HAS A TOTAL POPULATION OF APPROXIMATELY 600,000 STUDENTS, FACULTY AND STAFF. THE LABORATORY RESOURCES ACROSS OUR CAMPUSES HAVE BEEN VITAL FOR THE PANDEMIC RESPONSE AT THE UNIVERSITY OF CALIFORNIA. THE STATE OF CALIFORNIA HAS ALSO BEEN ADVANTAGED BY THE EXPERTISE AND CAPACITY PRESENT OF LABORATORIES, BOTH CLINICAL AND BASIC SCIENCE TO ADDRESS THE TESTING NEEDS OF THE STATE. THE UNIVERSITY OF CALIFORNIA HAS NOW PERFORMED HUNDREDS OF THOUSANDS OF TESTS FOR PATIENTS IN OUR UC HEALTH SYSTEM FOR CALIFORNIA PUBLIC HEALTH DEPARTMENTS AND FOR SPECIAL POPULATIONS INCLUDING THE HOMELESS, THOSE IN PRISONS AND THOSE IN SKILLED NURSING FACILITIES. WE ARE LOOKING FOR WAYS TO TEST OUR GENERAL POPULATION AS WE TRY TO RETURN TO IN-PERSON OPERATIONS. THE ACADEMIC HEALTH CENTERS ATTACHED TO UNIVERSITIES ARE A VITAL RESOURCE DURING THE PANDEMIC. WE HAVE EXPERTISE IN BASIC SCIENCES, CLINICAL LABORATORY MEDICINE, INFECTIOUS DISEASES AND THE CAPACITY TO DEVELOP AND VALIDATE NEW DIAGNOSTIC TESTS. WE BEGAN ADVOCATING IN JANUARY OF 2020 FOR THE ABILITY TO DEVELOP AND DEPLOY LABORATORY DEVELOPED TESTS FOR SARS-COV-2 AND ALL OF OUR CLEA CERTIFIED LABS AND SCIENTIFIC LABS DEVELOPED PC R TESTS RAPIDLY FOLLOWING THE VIRAL GENOME. BEING ABLE TO BRING THESE TO BEAR EARLY IN THE PANDEMIC WOULD HAVE RESULTED IN MORE AVAILABILITY AND GREATER SITUATIONAL AWARENESS. THE BASIC SCIENCE LABS AT THE ACADEMIC HEALTH CENTERS ALSO PROVIDED ADDITIONAL CAPACITY FOR OUR CLINICAL LABORATORIES. AT THE UNIVERSITY OF CALIFORNIA, THESE LABS HAVE BEEN VITAL RESOURCES FOR PRODUCING REAGENTS, AND TRANSPORT MEDIA WHEN SUPPLY CHAINS BECAME CONSTRICTED AND OUR ENGINEERING CAMPUSES HAVE ASSISTED IN 3D PRINTING OF SWABS AND OTHER SUPPLIES THAT WE REQUIRE FOR TESTING. WE HAVE WORKED ACROSS THE CLINICAL AND BASIC SCIENCES TO EXTEND CLEA LICENSES FROM OUR MEDICAL CENTERS INTO BASIC SCIENCE LABORATORIES, ON OUR CAMPUSES THAT DO NOT HAVE ATTACHED HOSPITALS. THIS IS GREATLY AUGMENTED THE TESTING CAPACITY OF OUR SYSTEM, THIS IS DIAGNOSTIC TESTING. IN INCREASED CAPACITY ALSO CREATES THE OPPORTUNITY TO TEST ASYMPTOMATIC INDIVIDUALS WHICH IS A REQUEST THAT WE HEAR FREQUENTLY FROM OUR EMPLOYEES AND FROM OUR STUDENTS. --MIGHT NOT BE RECOGNIZED WITH SYMPTOMATIC TESTING ONLY. CONSIDERING LARGE SCALE SURVEILLANCE TESTING AND POOLING ON OUR CAMPUSES AND ACROSS OUR HEALTH SYSTEM, RELIES ON THIS AUGMENTED CAPACITY AND ONSITE TESTING THAT BASIC LABORATORIES CAN PROVIDE. FREQUENT LOW COST TESTING WITH RAPID RETURN OF RESULTS AND WE ARE SPECIFYING RETURN OF RESULTS IN 24 HOURS OR LESS IS REQUIRED AS WE PLAN TO REOPEN IN PERSON OPERATIONS ON CAMPUSES AND WOULD BE AVAILABLE FOR OTHER BUSINESS SECTORS AND THEN FINALLY I WANT TO COMMEN THAT OUR ACADEMIC LABORATORIES HAVE BEEN ENGINES OF INNOVATIONS AND BELIEVE NEW TOOLS ARE REQUIRED FOR ENDING THE PANDEMIC. SO FOR EXAMPLE A LAB AT USC, IS OPTIMIZING SWAB TECHNOLOGY THAT PROVIDES A MOLECULAR BAR CODE FOR EACH SAMPLE AND THE TEST IS ONLY SIX DOLLARS FOR REAGENTS AND MATERIALS, SCALABLE, USES ONLY STANDARD EQUIPMENT AND DEPENDING ON THE SEQUENCING UNITS CAN RUN BETWEEN 1500 SAMPLES AND A HUNDRED THOUSAND SAMPLES PER DAY, THE PROCESS IS AUTOMATED AND LESS LABOR INTENSIVE THAN TRADITIONAL PC R, IT USES A DIFFERENT SUPPLY CHAIN AS NO RNA EXTRACTION IS REQUIRED AND IT'S NOR SENSITIVE THAN TRADITIONAL PC R ALLOWING FOR THE USE OF SELF-COLLECTED PESMENS. THIS TECHNOLOGY IS UNDER CONSIDERATION BY THE FDA FOR EMERGENCY USE AUTHORIZATION AND IF WE CAN BRING IT TO BEAR ON OUR CAMPUSES WILL ALLOW US TO TEST OUR ENTIRE POPULATIONS ON A REGULAR BASIS. I WILL SAY THAT REFERRALS FROM LARGE POPULATION SURVEILLANCE TO DIAGNOSTIC LABORATORIES IS CHALLENGING AND ALTHOUGH WE UNDERSTAND IT IS POSSIBLE AND WE ARE DOING THIS ON OUR UNIVERSITIES, IT IS CHALLENGING AND CAN RESULT IN BOTTLENECKS AND THERE ARE LEGAL AND REGULATORY HURDLES THAT POTENTIALLY COULD BE ADDRESSED TO ALLOW AN EMERGENCY SITUATION A MORE RAPID RETURN OF RESULTS AND CONTACT TRACING. WE ARE WORKING WITH CALIFORNIA DEPARTMENT OF PUBLIC HEALTH ON THIS ISSUE AND THESE CHALLENGES WILL COMPREHENSIVELY OUTLINE IN A NATIONAL ACADEMY OF MEDICINE REPORT IN 2018. SO IN CLOSING, I WOULD SAY THE ENTIRE ACADEMIC ENTERPRISE IS VITAL FOR OUR NATION FOR MANY REASONS INCLUDING RESPONSE TO PUBLIC HEALTH EMERGENCIES AND I URGE YOU TO CONSIDER, DEVELOP AND ENCOURAGE POLICIES AND PROCESSES THAT INCLUDE OUR ACADEMIC LABORATORIES AND PARTNERS IN OUR BATTLE TO CONTAIN THE PANDEMIC EMPLOY THANK YOU VERY MUCH. >> THANKS VERY MUCH DR. BYINGTON. I GUESS AFTER EACH PRESENTATION IF THERE'S ABSOLUTELY PRESSING QUESTION FOR THAT PRESENTER FROM 1 OF THE OTHER PANELISTS WE COULD HEAR THAT BUT OTHERWISE, I THINK WE WILL GO THROUGH AND THEN HAVE A MORE BROAD GENERAL CONVERSATION WITH WE'VE HEARD FROM EVERYBODY. I GUESS I'VE DISCOURAGED ANY QUESTIONS FROM HAPPENING SO LET'S MOVE ON. [LAUGHTER] NEXT PANELIST, THANK YOU DR. BYINGTON, NEXT PANELIST IS DR. EDWARD FESER WHO IS PROVOST AT OREGON STATE UNIVERSITY. PLEASE, LET'S HEAR WHAT'S HAPPENING IN OREGON. >> THANK YOU DR. COLLINS AND I REALLY APPRECIATE THE OPPORTUNITY TO SPEAK WITH EVERYONE TODAY. I WANT TO MAKE 2 WITH MAJOR POINTS BUT LET ME TELL YOU OREGON STATE IS THE LAND GRANT INSTITUTION, 32,000 STUDENTS, WE HAVE NO ACADEMIC MEDICAL CENTER OR MEDICAL SCHOOL HERE, WE HAVE A COLLEGE OF VETERINARY MEDICINE AND WE HAVE A LONG STANDING SET OF EXTENSION PARTNERSHIPS WITH ALL COUNTIES IN THE STATE WHICH WILL RELATE TO WHAT I'M GOING TO TALK ABOUT A LITTLE BIT. I WANT--I WANT TO EMPHASIZE OUR APPROACH IS BASED ON SURVEILLANCE TESTING, BUT I WANTED TO JUST MAKE IT A POINT AT THE OUTSET HOW IMPORTANT THE LAB CAPACITY AND RESEARCH UNIVERSITIES GENERALLY NOT FOR TO SUPPORT NONDIAGNOSTIC TESTING FOR SURVEILLANCE AND TO CONTRIBUTE TO THE BROADER PUBLIC HEALTH EMERGENCY, SO OUR INITIAL APPROACH WAS TO PROVIDE SUPPORT TO COMMUNITIES AND THEN FROM THERE DEVELOP ONSITE TESTING ON CAMPUS, AND THEN TWEP A SURVEILLANCE MODEL BUT 1 THING WE NEEDED TO DO AND RPGHT INSTITUTIONS MAY NEED TO DO THIS TOO, VETERINARY MEDICINE, COLLEGES WISH TO PARTNER WITH LOCAL HEALTH PROVIDERS AND LABS WHEN THE PANDEMIC HIT, WE HAD LITTLE DIAGNOSTIC CAPACITY IN THE REGION TO KEEP UP WITH THAT BUT WE WERE ABLE TO MOBILIZE PARTNERSHIPS WITH LOCAL PUBLIC HEALTH OFFICIALS, HOSPITAL SYSTEM, A LOCAL PRIVATE LAB AND INCREASE DIAGNOSTIC TESTING CAPACITY--HUMAN TESTING. SO I THINK THERE'S SOME LESSONS THERE FOR OTHER UNIVERSITIES WHO FIND THEMSELVES IN THE SAME POSITION WITHOUT ACADEMIC MEDICAL CENTERS. BUT LET ME EMPHASIZE THE SECOND POINT WHICH IS I THINK WE NEED JUST A NATIONALLY A DRAMENTICALLY INCREASED FOCUS ON PREVALENCE TESTING AND THAT'S BEEN OUR FOCUS HERE AT OREGON AND AT OREGON STATE WHICH IS TO GET A BETTER SENSE OF THE PREVALENCE OF THE VIRUS IN COMMUNITIES AROUND THE STATE OF OREGON TO INFORM THE PUBLIC HEALTH RESPONSE GIVEN THAT THE PANDEMIC IS ULTIMATELY A PUBLIC HEALTH CHALLENGE WE NEED TO SHAPE BEHAVIOR, THIS RELATES THEN TO HOW WE'RE MANAGING THE RETURN OF OUR STUDENTS TO OREGON STATE. WE KNOW WE NEED TO SHAPE THEIR BEHAVIOR, ENCOURAGE THEM TO FOLLOW PUBLIC HEALTH MEASURES, MASKING PHYSICAL DISTANCING AND SO ON. BUT WE'VE DEVELOPED A PROJECT HERE, IF YOU ARE INTERESTED, IT'S CALLED TRACE COVID-19. IF YOU TYPE IN TRACE, IN OREGON STATE, YOU WILL WILL FIND IT ON THE WEB, IT STANDS FOR TEAM BASED RAPID ASSESSMENT OF COMMUNITY LEVEL EPIDEMICS AND WE'VE BEEN SENDING TEAMS INTO OREGON COMMUNITIES, GONE IN 4 AT THIS POINT AND DONE RABD ORDER --RANDOM SAMPLES OF COMMUNITIES OVER WEEKEND PERIODS TO GET A SENSE OF COMMUNITY PREVALENCE. WHAT THIS HAS ALLOWED US TO DO IS TO GENERATE ESTIMATES OF THE LEVEL OF INFECTION, IN THOSE COMMUNITIES AND THE RELATION BETWEEN SYMPTOMATIC AND ASYMPTOMATIC INDIVIDUALS AND THEN ABLE TO INFORM THE PUBLIC IN THOSE COMMUNITIES. JUST AS AN EXAMPLE, WE HAD AN OUTBREAK AT A SEAFOOD PLANT ON THE OREGON COAST, WE WENT IN AND DID A PREVALENCE STUDY OVER A WEEKEND, DEVELOPED AN ESTIMATE OF THE PREVALENCE IN THE COMMUNITY AND THAT INFORMED PUBLIC RESPONSE. PRIOR TO THAT, THERE HAD BEEN NOT ENOUGH OR NOT SIGNIFICANT STRONG ENOUGH PUBLIC ADHERENCE TO PUBLIC HEALTH GUIDANCE. PREEMILYINARLY WE'VE DONE A SUBSEQUENT STUDY IN THAT COMMUNITY WHERE MONITORING PREVALENCE OVER TIME. WE'VE SEEN THOSE RATES NONAPOPTOTIC YOU COME DOWN, SO I WANT TO EMPHASIZE THAT IMPORTANCE OF REFULENCE FROM THE POINT OF VIEW OF DIRECTING RESOURCES AND MOTIVATING AND MOBILIZING PUBLIC HEALTH RESPONSE. WHAT WAS KEY HERE WAS THE LAND GRANT CONNECTION IN THE COMMUNITY THROUGH OUR EXTENSION SERVICE BECAUSE WE HAD 30 VANS GOING INTO THESE COMMUNITIES AND TAKING SAMPLES IN NEIGHBORHOODS WITH 68-80% RESPONSE RATE RIGHT AWAY ON THAT SAMPLING. SO WHERE DOES THAT BRING US FOR THE UNIVERSITY? WHICH IS A FOCUS AROUND SURVEILLANCE AS A WAY TO INFORM THE LEVEL OF PRESENCE OF CORONAVIRUS ON OR AT OREGON STATE CAMPUS HERE. SO WE'RE APPLYING THE SAME MODEL SURVEILLANCE BASED TESTING ISSUES USING THE SAME MODEL IN THE FALL. WE'RE COUPLING THAT WITH WASTE WATER SAMPLING WHICH WE'VE ALSO USED IN COMMUNITIES IN OREGON AND WERE ABLE TO CORRELATE THE WASTE WATER RESULTS WITH THE TESTS. AND WE'RE SEEING PRETTY GOOD SOUND RESULTS THERE, SO WE'RE--WE'RE HOPEFUL THAT THIS ALLOWS US TO THEN MONITOR THE PREVALENCE AND WE'RE FINDING THAT JUST KNOWLEDGE OF THAT PREVALENCE RATE HELPS CALM AS WELL AS MOTIVATE PUBLIC HEALTH RESPONSE. OF COURSE DIAGNOSTIC TESTING IS A COMPLEMENT AND THAT WE WON'T LEAVE THAT OUT, BUT WE'RE NOT IMAGINING LARGE SCALE MODELS WHERE WE TEST EVERY STUDENT ON REGULAR BASIS OR SOMETHING OF THAT SORT. SO I JUST--JUST TO LEAVE YOU, I WANT TO EMPHASIZE THE IMPORTANCE OF TAPPING MORE THE CAPACITY OF THE UNIVERSITIES IN BSL-2 LAB CAPACITY TO SUPPORT SURVEILLANCE TESTING. THE IMPORTANCE OF THE LAND RAGRANTS TO THE CONNECTION TO THESE COMMUNITIES TO THE DEGREE WE WANT TO USE THIS TESTING FOR UNIVERSITIES ACROSS THE UNITED STATES AND USE IT AS A COMPLEMENT TO INDIVIDUAL TESTING. SO THANK YOU. >> THANKS A LOT, I THINK ADMIRAL GIROIR HAS A QUESTION? >> YOU'RE MUTED, BRETT. OH, STILL MUTED. HMM. >> OKAY, HERE I AM. >> YEAH. >> AM I HERE. >> YEAH. >> OKAY, SORRY ABOUT THAT. I JUST WANT TO MAKE A COMMENT THAT WE'RE NOT REALLY TALKING MUCH ABOUT WASTE WATER SURVEILLANCE HERE BECAUSE IT'S NOT REALLY THE TOPIC BUT I'M VERY BULLISH ON THAT. THERE IS A CDC, A LARGE GROUP WORKING THIS, I'M DIRECTLY INVOLVED IN THAT AND WE'RE STARTING AN INTERAGENCY FEDERAL GROUP WITH EPA AND MULTIPLE OTHER AGENCIES. THERE ARE ABOUT A HUNDRED COMMUNITIES WHO ARE ACTIVELY--THAT WE KNOW OF THAT ARE ACTIVELY SURVEYING WASTE WATER. THERE 1S THAT HAVE IT DOWN AND THERE ARE A LOT OF STANDARDS BEING DEVELOPED HAVE SHOWN--IN VIRAL LOAD IN WASTE WATER, SO PARTICULARLY WANT TO FOOT STOMP THAT FOR THE ACADEMIC INSTITUTIONS THAT WE WOULD LOVE TO GET A REALLY RESEARCH ENVIRONMENT AROUND THIS AND AS YOU MIGHT IMAGINE NURSING HOMES, DORMS, BUT ALSO VERY, VERY IMPORTANT FOR US FOR VULNERABLE POPULATIONS IN CROWDED LIVING AREAS THAT WE CAN KEEP OUR EYE ON. SO THAT'S ALL I WANT TO SAY, BUT THE DATA, YOU KNOW IT'S NOT READY FOR PRIME TIME, BUT THE DATA ARE LOOKING REALLY GOOD AND THE CDC AND EPA HAVE DONE TREMENDOUS WORK. THE OREGON GRUP IF YOU ARE NOT LINK WIDE THEM, I AM HAPPY TO MAKE THAT CONNECTION. >> JUST AS A SIDE NOTE, THOSE ARE CONSISTENT WITH OUR RESULTS SOPHISTICATEDY WE WILL CONNECT INTO THIS GROUP. THANK YOU. >> TERRIFIC. THANK YOU VERY MUCH. NEXT WE WILL HEAR FROM PRESIDENT AND CHIEF EXECUTIVE OFFICER OF MEHARRY MEDICAL COLLEGE THAT IS DR. JAIM HILDRETH WHO IS ALSO A MEMBER OF MY ADVISORY COMMITTEE TO THE DIRECTOR. SO DR. HILDRETH. I THINK YOU ARE STILL MUTED? THERE YOU GO. >> THANK YOU FRANCIS FOR THE OPPORTUNITY TO BE PART OF THE DISCUSSION TODAY, I'M EXCITED TO BE HERE. FIRST ABOUT M EHARRY BLACK MEDICAL SCHOOLS FOUNDED IN THE COUNTRY. WE WERE FOUNDED IN 1876 AS A PLACE TO GIVE AFRICAN AMERICANS A PLACE TO LEARN MEDICINE BECAUSE AT THE TIME, AT LEAST HERE IN THE SOUTH THERE WAS NO PLACE FOR THEM TO DO THAT SO WE'VE BEEN AROUND FOR 144 YEARS. ONE OF OUR FOCUS SYSTEM ON DISADVANTAGED POPULATIONS, PARTICULARLY MINORITIES AND THAT HAS SHAPED A LOT OF WHAT WE'RE DOING WITH COVID-19. OUR ACTIVITIES INCLUDE RESEARCH, WE ARE WORKING ON 2 THERAPEUTIC CANDIDATES. WE'RE ALSO PART OF OPERATION WARP SPEED, THE EFFORT TO DEVELOP A VACCINE FOR COVID-19. WE'RE PART OF THAT. AND HIV RESEARCH FOR LONG STANDING, I'VE BEEN WORKING ON HIV SINCE 1986 AND AS IT TURNS OUT A LOT OF INDIVIDUALS INVOLVED IN THE COVID-19 VACCINE ARE MY COLLEAGUES SO IT'S JUST NATURAL FOR ME TO GET INVOLVED IN THAT. SO VERY EXCITED ABOUT THAT. WE ALSO DO A LOT OF COMMUNITY ENGAGEMENT WORK WHICH I WILL TALK ABOUT IN JUST A BIT AND OF COURSE WE'RE TAKING CARE OF COVID-19 PATIENTS IN OUR HOSPITAL AND CLINIC. SINCE WE ARE HEALTHCARE ORGANIZATION, ALL OF OUR FACULTY STAFF AND STUDENTS ARE BEING TESTED AS MANDATORY BOTH TO PROTECT OUR STUDENTS AND OUR FACULTY BUT ALSO TO PROTECT THE PATIENTS THAT COME TO US FOR THEIR CARE. WE GERONTOLOGYSTS GANNA THAT LAST MONTH DURING A MANDATORY TESTING. WE ALSO STARTED BACK IN MARCH DOING COVID-19 TESTING IN THE COMMUNITY AND AGAIN, THAT WAS MY VIEW THAT WE NEEDED TO MAKE SURE THAT EVERYONE HAD ACCESS TO TESTING. THE LARGE HOSPITAL SYSTEMS HERE AND THEIR TREMENDOUS HOSPITAL SYSTEMS, VANDERBILT, ST. THOMAS AND HCA, THEY'VE DONE A GREAT JOB OF COMING TOGETHER IN THIS EFFORT, BUT THEY WERE TESTING THEIR PATIENT PANELS AND WE WANTED TO MAKE SURE THAT UNINSURED, DISADVANTAGED INDIVIDUALS COULD GET TESTED AS WELL. SO OUR TESTING BECAME PART OF THE CITY'S EFFORTS AND AS A MATTER OF FACT, MEHARRY IS RUNNING THE 3 ASSESSMENT CENTERS FOR THE CITY AND WE'RE DOING AS MANY AS 2000 TO 3000 TESTS PER DAY HERE IN NASHVILLE. WE ARE ALSO TESTING IN PRISONS AND ASSISTED LIVING FACILITIES AND THE THEME THERE IS THAT WE WANT TO BE FOCUSED ON VULNERABLE POPULATIONS AND AS YOU KNOW, THE ELDERLY, PEOPLE OF COLOR AND THOSE WITH UNDERLYING CONDITIONS, ARE MUCH MORE PRONE TO SEVERE DISEASE AND DEATH. SO WE'VE BEEN FOCUSED ON TRYING TO MAKE SURE THAT TESTING AND CONTACT TRACE CAN BE DONE IN THOSE POPULATIONS. THE OTHER THING I'M REAL EXCITED ABOUT IS THAT WE'RE PARTNERING WITH CHURCHES, LOCAL CHURCHES TO DO TESTING. WE HAVE A MOBILE TESTING TEAM THAT GOES AND SETS UP WITH THE CHURCHES ON SATURDAYS, WE'VE BEEN DOING THAT FOR THE LAST COUPLE OF MONTHS AND THAT'S BEEN HIGHLY SUCCESSFUL. 200-300 PEOPLE WILL COME DURING THOSE SESSIONS AT THE CHURCHES TO BE TESTED AND AGAIN, WE'RE TRYING TO FOCUS ON THE AFRICAN COMMUNITY WHERE THERE'S A LOT OF--AFRICAN AMERICAN COMMUNITIES WHERE THERE A LOT OF PEOPLE PRONE TO THE DISEASE. ANOTHER THING I WOULD LIKE TO SHARE WITH YOU IS WE'RE ARE ALSO WORKING WITH THERMAL FISHER TO BECOME REGIONAL TESTING CENTERS FOR THE 107 HBCUs WHICH MANY OF THEM DO NOT HAVE THE RESOURCES THAT ARE NEEDED TO DO TESTING OF THEIR STUDENTS AND THERMO-FISHER HAS AGREED TO ASHES CYST US WITH SETTING UP THESE CLEA-CERTIFIED LABS. AND THE IDEA WOULD BE THAT THE HBCUs ONCE THEY DEVELOP THEIR PROTOCOLS AND TESTING ALGORITHMS FOR THE STUDENTS,--I MADE A PROPOSAL TO CONGRESS THAT THE BEFORE MEDICAL SCHOOLS--WE ALREADY ARE A CONSORTIUM BUT WE BELIEVE THAT AS A CONSORTIUM, WE BE COULD HAVE A HUGE IMPACT IN TERMS OF MINORITY COMMUNITIES AND WHAT COVID-19 IS DOING FOR REASONS OF CULTURAL COMPETENCE, WE ARE ALREADY ENGAGED WITH THE COMMUNITIES. THE CONNECTION TO FAITH COMMUNITIES IS DEEP AND STRONG AND WE ARE WORKING ON GETTING RESOURCES TO IMPLEMENT THAT. WE REVIEW THE PARTNERSHIP WITH THE HBCUs HAS PART OF THE PARTNERSHIP TO MAKE SURE OUR TALENT, EXPERTISE AND CAPACITY CAN BE BROUGHT TO BEAR IN THAT SETTING AND I'M REALLY EXCITED ABOUT THAT. SO FROM THE POINT OF VIEW OF COMMUNITY ENGAGEMENT, RESEARCH AND OTHER ACTIVITIES, I THINK MEHARRY HAS BEEN REALLY ACTIVE. I HAPPEN TO DISAGREE WITH THE CDC THAT NOT EVERYONE SHOULD BE TESTED WHOSE COMING BACK TO THE CAMPUS, ESPECIALLY IN THE CAMPUS IS LOCATED IN A COMMUNITY WHERE THERE'S A HIGH PREVALENCE OF THE VIRUS. EE ALSO KNOW IN SOME SETTINGS THOSE STUDENTS WILL GO BACK HOME AND POSSIBLY TAKE THE VIRUS TO PEOPLE THAT IN HIGH RISK CATEGORIES AND I THINK CERTAINLY IN THAT CASE WE HAVE TO BE REEIVE AND DO EVERYTHING WE CAN DO--PREEMPTIVE AND DO EVERYTHING WE CAN TO KEEP THE VIRUS OUT OF THOSE HOUSEHOLDS. SO THAT'S WHAT WE'RE DOING IN OUR PARTNERSHIPS. BUT BOTTOM LINE FOR US IS FOCUSING ON MAKING SURE THAT THE DISPARITIES IN COVID-19 ARE ADDRESSED BY THE ACTIVITIES THAT WE DO AND WE'RE EXCITED ABOUT THAT. THANK YOU FRANCIS. >> THANK YOU VERY MUCH. YOU SAID YOU ARE DOING MANDATORY TESTING ON PEOPLE IN YOUR MEDICAL CENTER, HOW FREQUENTLY ARE THE TESTS APPLIED TO THOSE INDIVIDUALS? >> WE'RE DOING EVERYONE INDIVIDUALLY AT FIRST, FRANCIS AND THEN WE'RE GOING TO REVERT TO A POOL PROCESS. >> ABOUT HOW FREQUENTLY WOULD EACH PERSON GET TESTED THEN, HOW OFTEN? >> WE ARE PROBABLY GOING TO DO THAT EVERY WEEK TO 10 DAYS. >> THAT'S A CHALLENGE. BRETT HAS A QUESTION. >> AM I UNMUTED? >> YES, YOU ARE UNMUTED. >> THANK YOU VERY MUCH FOR THAT PRESENTATION, THE TYPE OF NETWORK YOU SUGGESTED WHICH WOULD EXPAND CAPACITY PARTICULARLY FOR AN UNDERSERVED ENVIRONMENT AND THE HIRISK ENVIRONMENT, WE HAVE MONEY FOR THAT, OKAY? THERMO-FISHER HAS DONE A REALLY GOOD JOB, SOME OF IT'S FRANCIS' MONEY, I HAVE NO PROBLEM SPENDING HIS BUT THE RADX ATP PROGRAM REALLY FOCUSES ON EXPANDING NETWORKS IN A VERY PRACTICAL WAY, MY OFFICE IS ALSO INTERESTED AS WELL AS EVEN DPA DEFENSE PRODUCTION SO DON'T BE SCARCE IF YOU NEED RESOURCES FOR THIS TYPE OF NETWORK. WE WOULD BE HONORED TO WORK WITH YOU AND HELP YOU GET THIS ESTABLISHED. OVER. >> I WON'T BE BASHFUL, I ASSURE YOU. >> AH, YES AND LISTENING IN RIGHT NOW IS RICK BRIGHT WHO'S RUNNING THE RADX ATP AND RICK STROMBERG, AND TARA AND YOU DON'T KNOW WHAT THOSE VARIOUS RADX PROGRAMS ARE CHECK OUT THE NEW ENGLAND JOURNAL FROM 2 DAYS AGO. OKAY, THANK YOU. LET'S MOVE TO DR. LARRY JAIM ESTIMATE THADON, EXECUTIVE VICE PRESIDENT, UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM AND DEAN OF THE PERELMAN SCHOOL OF MEDICINE. >> THANK YOU DR. COLLYNNS AND ADMIRAL GIROIR, SECRETARY VERMA, THANK YOU FOR HOSTING THIS PANEL. I WANT TO COVER 3 TOPICS AND THEN I HAVE A COUPLE RECOMMENDATIONS FOR FURTHER DISCUSSION. THE 3 TOPICS WILL BE THE PLANNING AT THE UNIVERSITY OF PENNSYLVANIA FOR STUDENTS COMING BACK IN THE FALL. THE SECOND WILL BE SOME INSIGHTS INTO OUR TESTING INNOVATION AND THE IMPACT IT COULD HAVE AND THE THIRD WILL BE JUST TO GO OVER SOME IDEAS GOING FORWARD. SO UNIVERSITY OF PENNSYLVANIA HAS 12 SCHOOLS, WE ALSO HAVE A HEALTH SYSTEM. WE'VE LEARNED A LOT ABOUT OUR PLANNING FOR THE FALL FROM OUR HEALTH SYSTEM AND I WILL SAY A BIT MORE ABOUT THAT. WE'VE GOT ABOUT HALF UNDERGRADUATE STUDENTS, HALF GRADUATE AND PROFESSIONAL STUDENTSA THE 12 SCHOOLS, ALTOGETHER A LITTLE OVER 15,000 STUDENTS AND MORE THAN THAT IN TERMS OF STAFF AND FACULTY. AN RNT CONTEXT FOR A CITY LIKE PHILADELPHIA IS IN ADDITION TO THE UNIVERSITY OF PENNSYLVANIA THERE ARE MANY OTHER UNIVERSITIES WHERE STUDENTS WILL BE COMING BACK AT ROUGHLY THE SAME TIME SO WE HAVE TEMPLE, DREKSLE, HAVERFORD, SWARTHMORE, THE LIST GOES ON, OTHER SCHOOLS AND WE'VE BEEN IN CONTACT WITH THEM TO TRY TO UNDERSTAND THEIR TIMING AS WELL AS PLANS FOR TESTING AND EVALUATING STUDENTS. --FROM ALMOST EVERY STATE IN THE COUNTRY, WE'RE STILL EVALUATING HOW MANY INTERNATIONAL STUDENTS MAY COME BACK TO CAMPUS, SOPHISTICATEDY WE'RE THINKING A LOT ABOUT THE LOGISTICS OF MOVE-IN, HOW MANY STUDENTS CAN BE IN A ROOM? HOW MANY CAN SHARE A BATHROOM? WHAT KIND OF TESTING SHOULD BE DONE BEFORE THEY COME BACK TO CAMPUS AND ONCE THEY'RE ON CAMPUS AND OF COURSE A STRONG SOCIAL COMPACT OF BEHAVIOR ON CAMPUS. OUR CURRENT PLANS, IF POSSIBLE ARE TO PRETEST ALL STUDENTS BEFORE THEY TRAVEL INTO PHILADELPHIA IN PART SO THAT IF THEY TEST POSITIVE, THEY WILL STAY AT HOME AND QUARANTINE OR ISOLATE BEFORE TRAVELING AND THEN OUR PLANS ARE TO TEST STUDENTS UPON ARRIVAL. SO THERE WOULD BE A SECOND TEST AND THEN FOLLOWING THAT WE'RE PLANNING SURVEILLANCE TESTING GOING FORWARD. LIKEWISE FOR THOSE ENGAGED IN WORKING IN THE DORMITORIES FOR THE FACULTY WHO WILL BE HOLDING CLASSES, WE WOULD BE TESTING THEM AS WELL. MOST OF THE CLASSES ARE GOING TO BE ONLINE. THERE WILL BE SOME HYBRID CLASSES AS WELL. WE HAVE BEEN INFORMED BY THE HEALTH SYSTEM AS DR. HILDRETH WAS OUTLINING, SO SOME MONTHS AGO, WE WERE BEGINNING TO SCREEN PREGNANT PATIENTS AS THEY CAME IN FOR DELIVERY, SIGNIFICANT NUMBERS OF THEM TESTED POSITIVE EVEN THOUGH THEY WERE NOT SYMPTOMATIC. LIKEWISE AS WE'VE BEEN REOPENING MANY OF OUR CLINICAL ACTIVITIES, WE'VE BEEN TESTING PATIENTS AS THEY COME IN FOR HIGHER RISK PROCEDURES LIKE SURGERY EITHER IN-PATIENT OR OUT-PATIENT AND WE'VE LEARNED THAT YOU KNOW AGAIN, A SIGNIFICANT NUMBER OF THEM ARE TESTING POSITIVE EVEN THOUGH THEY HAVEN'T HAD SYMPTOMS AND IT'S ALLOWED US TO CREATE A SAFER CLINICAL ENVIRONMENT. INTERESTINGLY, OUR SURVEILLANCE TESTING AND HEALTH SYSTEM EITHER FOR ANTIBODIES OR ACCESSOLE FOR CORONAVIRUS HAS SHOWN LOW OUTBREAKS SINCE TESTING SO THE STEPS WE'VE BEEN TAKING USING UNIVERSAL MASKING AND HAND WASHING SEEM TO BE CREATING A VERY SAFE ENVIRONMENT AND I THINK THAT INFORMS SOME OF OUR THINKING FOR THE CAMPUS. SO THE SECOND TOPIC IS AROUND TEST INNOVATION AND IMPACT. FRANCIS, WE BEGAN BACK IN MARCH THINKING A LOT ABOUT NOVEL APPROACHES TO TESTING IN ADDITION TO THE TRADITIONAL RTPC R FOR THE VIRAL GENE SEQUENCE AND I WILL GIVE A COUPLE OF EXAMPLES AND I THINK THE PROGRAM YOU JUST ROLLED OUT, I THINK WILL BE QUITE IMPACTFUL. SO 1 OF OUR FACULTY HAS DEVELOPED A FLUORESCENT INSITU-HYBRIDIZATION DETECTION METHOD. IT CAN'T BE DONE REALLY AT SCALE BUT YOU CAN PICK UP VIRUS IN SALIVA SAMPLES, IT'S USEFUL IN PATHOLOGY, I MENTION IT BECAUSE IT'S VERY DIFFERENT. WE'VE ALSO BEEN WORKING ON AN RT-LAMP PROTOCOL WE'VE BEEN SHARING WITH OTHER ACADEMIC INSTITUTIONS THIS, RESEMBLES RTPC R BUT THE DUTY OF IT IS THAT THE REAGENTS DON'T OVERLAP SO THE SUPPLY CHAIN AND COMPLETELY DIFFERENT THAN THE SUPPLY CHAIN FOR RTPC R, IT'S REQUIRED. ONE OF OUR FACULTY ACTUALLY SYNTHESIZED THE ENZYME INVOLVED THEMSELVES, SO WE HAVE A LOT OF THAT AND IT CAN BE SCALED UP SO WE'RE LOOKING AT THAT AS A POSSIBLE WAY TO DO SURVEILLANCE TESTING WHILE WE'RE PURSUING THE EUA FOR THE RT-LAMP PROCEDURE. BUT I THINK IT'S REALLY IMPORTANT THAT WE SUPPORT SOME OF THESE INNOVATIVE APPROACHES SO THAT WE CAN HAVE NONREDUNDANT APPROACHES TO TESTING. AND THEN LASTLY, WE'VE GOT ANOTHER FACULTY MEMBER AS ADMIRAL GIROIR WAS MENTIONING, THESE POINT OF CARE ANTIGEN TESTS CAN BE VERY POWERFUL AND SHE'S IN OUR PATHOLOGY DEPARTMENT, THIS IS A TEST THAT CREATES BUBBLES WHEN IT'S POSITIVE AND THE IDEA IS TO DETECT THESE BUBBLES WITH AN IPHONE CAMERA SO IT CAN BE DONE POINT OF CARE AND THAT WAY. INTERESTING NEED, I THINK IS TO PARTNER WITH ENGINEERING SCHOOLS ON SOME OF THESE DEVICES AND ALSO ON THE ROBOTICS. YOU KNOW SOMEBODY WHO DID A LOT OF ASSAYS IN THE LABORATORY MYSELF, IT'S 1 THING TO DO 24 WELLS, IT'S HARD TO DO 96. ONCE YOU GO ABOVE THAT YOU'RE REALLY TALKING ABOUT THE USE OF ROBOTICS BOTH TO AVOID MISTAKES BUT ALSO TO HAVE ACCURATE PIPETTING AND SO WE NEED TO FOCUS ON THAT AS WELL AS THE TESTS THEMSELVES. WE'VE DONE THIS VOLUNTARILY OFTEN WITH THE SUPPORT--[AUDIO CUTS OUT ]--SUGGESTIONS WE CAN DISCUSS FURTHER. I THINK IT WOULD BE REALLY IMPORTANT FOR US TO FUND TEST INNOVATION AND SCALE UP. NOT MAYBE THE SCALE WE'VE DONE WITH VACCINES BYOU IN A SIMILAR MANNER IN TERMS OF A CALL FOR ACTION. WE ALL SEE THE DATA WITH COVID-19 SPREAD, WE ANTICIPATED BY THIS TIME IN JULY THAT WE WOUD BE ON THE BOTTOM OF THE CURVE AS WE WERE COMING BACK INTO CAMPUS, IT'S NOT WHERE WE ARE. I THINK WE NEED TO TRY MORE AGGRESSIVE APPROACHES BOTH FOR DIAGNOSTICS AND SURVEILLANCE TO PARTIALLY INFORM BEHAVIOR BUT ALSO PUBLIC HEALTH MEASURES. SO 1 RECOMMENDATION IS TO CONTINUE THAT SUPPORT. THE SECOND IS TO SCALE UP THE TOTAL NUMBER OF TESTS BEING PERFORMED ACROSS THIS COUNTRY, IDEALLY WITH LOWER COSTS TESTS. I'M NOT SURE EXACTLY WHAT THE NUMBER IS, IT WOULD BE INTERESTING TO DEBATE THIS BUT MOST OF THE THEORETICAL STUDIES SUGGEST THAT IF WE COULD TEST MORE FREQUENTLY, EVEN WITH TRADE OFFS ON SENSITIVITY AND SPECIFICITY, WE WOULD MORE RAPIDLY BE ABLE TO IDENTIFY AND ISOLATE PEOPLE AND DO CONTACT TRACING. SO TO HAVE BOTH SCALE AND FREQUENCY OF TESTING IS A BIG DEMAND AND THE THIRD THING I WOULD LIKE TO PUT ON THE TABLE HAS TO DO WITH THE ASYMPTOMATIC TESTING. IT'S NOT RECOMMENDED NOW, IT'S NOT REIMBURSED, AND YET WE KNOW THAT 80% OF INFECTED PEOPLE ARE A SYMPTOMATIC AND THE LATEST DEMOGRAPHIC SUGGESTS THAT MANY OF THE PEOPLE WHO ARE TURNING POSITIVE ARE IN THE YOUNGER AGE GROUPS AND SO, I THINK IF WE CAN BEGIN TO TAP THAT PREVALENCE FURTHER, IT'LL HELP US TO CONTAIN THIS MORE QUICKLY. SO I'LL CLOSE THERE AND THANK YOU FOR PARTICIPATING IN THE PANEL. >> THANKS,-- >> CAN I JUMP IN. >> SURE. >> THESE ARE GREAT THOUGHTS, YOU KNOW OBVIOUSLY, WE ARE HOLDING NOTHING BACK TO DEVELOP MORE TESTS WE KNOW EXACTLY WHAT MANUFACTURES CAN DO, WHERE THE EUAs ARE, TO THE DEGREE WE CAN WE ARE OBVIOUSLY TRYING TO SIMULATE THE RADX AND AREAS FOR SURE, FRANCIS WILL TALK ABOUT THE FUNDING HE HAS AVAILABLE TO DO THAT. A COUPLE OF THINGS, NUMBER 1 IS, I JUST WANT TO MAKE THE GENERAL POINT THAT YOU MENTIONED SO MANY VERY INTERESTING THINGS THAT WERE ALL INVOLVED IN, EVEN IF YOU ARE NOT SUBMITTING AN EUA, THE KINDS OF DATA THAT YOU HAVE PARTICULARLY SALIVA TESTING IS A BEAR. THE GENERAL DATA SUBMITTED TO THE FDA IS ALL OVER THE PLACE AND GENERALLY POORLY SENSITIVE, I'M NOT TALKING ABOUT NEXT GEN SEQUENCING ON SALIVA SO I WOULD JUST LIKE TO URGE EVERYONE, YOU KNOW YOU COULD SUBMIT LEGALLY AN AMICUS BRIEF, THIS IS THE WHAT WE DID, THESE ARE THE METHODS, THESE ARE INCREDIBLE LOAMACYY IMPORTANT WHEN WE FIGURE OUT WHAT'S WORKING ON NOT IN THE AREA THAT THE ACADEMICS COULD MAKE A HUGE IMPACT AS WE TRY TO SCALE. SO I JUST WANT TO ENCOURAGE THAT, IN FACT, THAT'S REALLY WHAT THE GATES FOUNDATION DID ABOUT THE NAISAL SWAPS. GATES WITH THE HEALTH SYSTEM OUT THERE, ABOUT THE NAISAL FOAM SWABS TO VALIDATE THAT, THAT WAS REALLY IMPORTANT IN GETTING US AWAY FROM TOTAL NAISAL-PHARYNGEALL SWABS. BUT THANK YOU. THESE WERE GREAT REMARKS. >> THEY WERE INDEED. YET FOR SOME OF THE INNOVATIONS YOU TALKED ABOUT, A QUICK ADVERTISEMENT FOR RADX AND THE PROGRAM THAT WAS AIMED TO DO IN WHAT YOU WERE TALKING ABOUT IN TERMS OF SUPPORTING TEST INNOVATION AND SCALE UP. SO RADX HAS SEVERAL COMPONENTS AND I WILL MENTION 1 THAT'S THE BEST FIT WHICH IS RADX TECH, WHICH IS DESIGNED FOR PEOPLE WHO INVENTED A PLATFORM BUT NEED TO FIGURE OUT HOW TO VALIDATE IT AND DETERMINE WHETHER IT CAN BE SCALED, PEOPLE COME FORWARD WITH APPLICATIONS. WE'VE NOW HAD MORE THAN 600 OF THOSE COMPLETED APPLICATIONS, THEY GET EVALUATED VERY QUICKLY AND DECIDE IF THEY LOOK PROMISING ENOUGH TO THROW THEM INTO THE SHARK TANK WHICH IS POPULATED BY ENGINEERING, TECHNOLOGY AND BUSINESS EXPERTS WHO THEN IN THE SPACE OF A WEEK FIGURE OUT WHETHE THIS IS IN FACT SOMETHING THAT COULD BE SCALED AND COULD RESULT IN A MAJOR ADVANCE AS FAR AS ACCESS TO TESTING. OUT OF THAT PROCESS WE NOW HAVE SOME 28 THAT HAVE MADE IT THROUGH THE SHARK TANK AND INTO THE NEXT PHASE AND A FEW OF THOSE, VERY FEW, LOOK AS IF THEY MAY HAVE GRADUATED INTO BEING AN OPPORTUNITY FOR FULL SCALE-UP, AT WHICH .10S OF MILLIONS OF DOLLARS CAN BE MADE AVAILABLE IN ORDER FOR THAT--[AUDIO CUTS OUT ]--SO MANY COME NOTHING THE DOOR AND NEED TO EVALUATE, BUT WE HAVEN'T PAUSED YET SO ANY OF THE 1S YOU MENTIONED LARRY MIGHT BE BENEFITED BY THAT PARTICULAR STRATEGY THAT'S WHAT WE'RE THERE FOR AND THE CONGRESS GAVE US A BILLION AND A HALF DOLLARS TO GO AFTER THESE OPPORTUNITIES. SO WE ARE NOT SHORT ON RESOURCES AND WE'VE BEEN REALLY PLEASED. MOST OF THEM HAVE ACTUALLY COME FROM SMALL BUSINESSES. JUST A QUICK WORD ABOUT THIS? >> SURE. THANKS FRANCIS AND I THINK DR. JAIM ESTIMATE THADON REALLY CAPTURED THE EXCITEMENT AND POTENTIAL OF THIS TYPE OF PROGRAM AND ACTUALLY COVERED SEVERAL OF THE TECHNOLOGY TYPES THAT WE'RE SEEING THE KINDS OF INNOVATIONS, SO WE DEFINITELY ENCOURAGE EVERYONE TO CONTINUE TO PARTICIPATE, UNFORTUNATELY IT IS A VERY TIGHT TIME PRESSURE FOR SCALE UP THAT WE'RE LOOKING AT, HOWEVER, WE'VE CREATED ALTERNATE PATHWAYS, WE CALL THEM REDIRECTS, PROMISING FUTURISTIC AND RADICAL IDEAS CAN STAY ALIVE AND CONTINUE FUNDING, GETTING THAT TO OTHER INVESTMENTS BOTH WITHIN THE U.S. GOVERNMENT BUT ALSO MATCHING UP WITH PRIVATE EQUITY INVESTMENTS SO WE ARE ABSOLUTELY COMMITTED TO KEEPING THAT INNOVATIVE AND ENTREPRENEURIAL SYSTEM GOING. >> SO YEAH, MORE CAN BE READ ABOUT THAT IN THE NEW ENGLAND JOURNAL PIECE FROM 2 DAYS AGO, OR GO TO THE WEBSITE, LOOK UNDER RADX, GREAT. WE SHOULD KEEP MOVING. NEXT I WANT TO INTRODUCE DR. SALLY KORNBLUTH WHO IS THE PROVOST AT DUKE UNIVERSITY. SO DR. KORNBLUTH, LET'S HEAR ABOUT THIS. >> THANK YOU VERY MUCH FOR THE INVITATION DR. COLLINS. AS YOU KNOW DUKE UNIVERSITY'S IN DURHAM, NORTH CAROLINA WE ARE IN AN AREA OF THE COUNTRY WHERE WE ARE SEEING GREATER SURGE IN CASES. THIS HAS INFORMED OUR OPENING STRATEGY QUITE A BIT. WE DO HAVE A HEALTH SYSTEM AND AS HAS BEEN DISCUSSED WE HAVE BEEN DOING ALL ALONG ROBUST SYMPTOMATIC TESTING WITH A TURN AROUND OF LESS THAN 24 HOURS. WE'VE BEEN--WHEN WE SEE EMPLOYEE CASES WE'VE HAD A VERY ROBUST CONTACT TRACING, CONTINUAL CONTACT WITH STUDENTS AND THE SAME FOR STUDENT WHO IS ARE TESTING POSITIVE. I HAVE TO SAY AS WE THINK ABOUT SURVEILLANCE TESTING OF STUDENTS, 1 OF OUR CONCERNS OF THE STUDENTS THEMSELVES OR ACTUALLY OUR LARGER ARE CONCERN ARE THE STUDENT FACING STAFF THAT HAVE A LOT OF CONTACT WITH THE STUDENTS. HOUSEKEEPING, BUS DRIVERS, FOOD SERVICE, ET CETERA, ET CETERA AND THOSE ARE VEHICLES FOR ANY INFECTION THAT MIGHT COME IN FROM ALL AROUND THE COUNTRY WITH OUR STUDENTS BACK INTO THE DURHAM COMMUNITY. AS WE'RE THINK BEING STUDENT TESTING, WE'RE THINK BEING SURVEILLANCE TESTING OF THE STAFF THAT HAVE A LOT OF CLOSE CONTACT WITH STUDENTS. WE ARE PLANNING TO TEST ALL OF OUR STUDENTS UPON ARRIVAL. THE UNDERGRATUATE POPULATION, WE ARE ALSO PLANNING TO TEST OUR GRADUATE AND PROFESSIONAL STUDENTS, I WILL SAY THAT THAT INITIAL TEST IS GOING TO BE DONE VIA COMMERCIAL SERVICES BUT WE ARE THEN GOING TO MOVE TO SURVEILLANCE TESTING OF OUR POPULATION AND WHAT WE HAVE DECIDED TO DO WE ARE NOT--I WILL SAY SOME OF OUR PEERS ARE TALKING ABOUT PREARRIVAL TESTING, QUARANTINE UPON ARRIVAL, WE'RE NOT DOING THAT EXCEPT FOR THE QUARANTINE NECESSARY TO HEAR ABOUT THEIR FIRST TEST. BUT AFTER THAT, WHEN WE THINK ABOUT SURVEILLANCE TESTING WE ARE HOPING TO SURVEILL OUR STUDENT POPULATION AND AGAIN THOSE STUDENTS FACING EMPLOYEES ONCE A WEEK. AND WHAT WE ARE DOING IS PARTNERING WITH OUR AIDS VACCINE INSTITUTE IN A NONCLEA CERTIFIED ENVIRONMENT FIRST, POOL TESTING WHERE THEIR CALIBRATION INDICATES THEY CAN DO WITH NO LOSS OF SENSITIVITY POOLS OF 5. WE WILL DO REGULAR TESTING, THEY REALLY DON'T LOSE MUCH SENSITIVITY HONESTLY UP TO POOLS OF 10, BUT THEY'RE STARTING AT POOLS OF 5, BUT THEY ARE GOING TO RAMP UP OVER THE FIRST SEMESTER ULTIMATELY REACHING ABOUT 10,000 INDIVIDUALS BEING SURVEYED EACH WEEK BY ABOUT MIDSEPTEMBER. I WILL SAY PART OF OUR MOTIVATION ORIGINALLY IN GOING TO THE VACCINE INSTITUTE IS THEY'RE USING A DIFFERENT PLATFORM, OUR CLINIC DOES HAVE SURVEYS MRI CHAIN ISSUES, OUR CLEA-CERTIFIED TESTING USING A DIFFERENT PLATFORM. WE ARE STARTING TO TALK WITH OUR GENOME CENTER WHERE WE COULD SCALE UP SURVEILLANCE TESTING ACROSS THE BOARD USING HAD NEXT GEN SEQUENCING THAT'S A DIFFERENT SUPPLY CHAIN AND PLATFORM. I HAVE TO SAY 1 THING THAT WE'RE CONCERNED ABOUT THAT IS UNIQUE MAYBE TO THE STUDENT POPULATION IS COMPLIANCE. SO WE ARE GOING TO HAVE STUDENTS THAT FIRST OF ALL HAVE TO FILL OUT A SYMPTOM MONITORING APP EVERY DAY AS WELL AS MASKING AND SOCIAL DISTANCING, ET CETERA BUT--[AUDIO CUTS OUT ]--GO TO CLASS FOR INSTANCE, IF THEY DON'T SHOW UP FOR THEIR TEST. THE OTHER THING THOUGH, THAT WE HAVEN'T REALLY TALKED ABOUT IS THERE'S THE TECHNICAL ISSUES CONCERNED WITH LARGE SCALE SURVEILLANCE TESTING BUT THERE'S ALSO THE MANUEL LABOR AND THE ORGANIZATION AND THE LOGISTICS OF COLLECTING SAMPLES FROM THAT NUMBER OF STUDENTS, PROCESSING ALL THE POOLS, ET CETERA. SO WE ARE NOW SORT OF RAMPING UP IN THE AIDS VACCINE INSTITUTE TO THINK ABOUT HOW WE WILL BRING ON MORE INDIVIDUALS FOR POOLING, WHAT CAN BE DONE IN AN AUTOMATED WAY, WHAT HAS TO BE DONE MANUALLY, ET CETERA, SO THAT'S AN ONGOING ENDEAVOR. I WILLAY FINALLY THAT WHEN WE THINK ABOUT USING THESE TESTS AS WAS MENTIONED PREVIOUSLY, IF WE GET A POOL OF 5 THAT IS POSITIVE--IF THERE'S A POSITIVE IN THE POOL, OBVIOUSLY WE WILL RETEST THOSE 5 IN A CLEA CERTIFIED ENVIRONMENT AND THEN A STUDENT WOULD BE INFORLED POSITIVITY STRICTLY THROUGH A CLINICAL TESTING PROT COL. FINALLY I WILL SAY WHEN WE LOOK AT THE SENSITIVITY OF THESE TESTS, WE'RE DOING EXTENSIVE VALIDATION IN THE VACCINE INSTITUTE LOOKING AT THE SENSITIVITY OF THE DETECTION FOR VIRAL LOAD, YOU KNOW HOW MANY COPIES OF VIRUS CAN WE DETECT AND YOU KNOW WE CAN GET REALLY GREAT SENSITIVITY AND WE WANT TO MAKE SURE THAT WE USE SIMILAR CRITERIA, CALIBRATION, ET CETERA AS WE TRY TO INVOLVE THE GENOME CENTER AND NEXT GEN SEQUENCING THAT WE'RE GETTING SENSITIVE RESULTS, USING THE SAME STANDARD SAMPLES, ET CETERA, DILUTION SERIES AND ALSO THAT WE CAN DETERMINE OUR FALSE-POSITIVE, FALSE-NEGATIVE RATE, ET CETERA. SO WE'RE PROBABLY A COUPLE MONTHS AWAY FROM EVEN THINKING ABOUT THE NEXT GEN SEQUENCING SET UP BUT WE BELIEVE BY THE TIME THE STUDENTS ARRIVE WE WILL BE ABLE TO USE PC R SCREENING THROUGH THE AIDS VACCINE INSTITUTE WITH POOLED SAMPLES FROM DAY 1. >> GREAT. >> I SAW ADMIRAL GIROIR CRINGING A BIT WHEN YOU SAID YOU WOULD USE A COMMERCIAL SUPPLIER FOR YOUR ORIGINAL SCANNING, SO WHY NOT USE YOUR SURVEILLANCE SYSTEM RIGHT FROM THE BEGINNING? >> WE HONESTLY WERE NOT--FIRST OF ALL WE WERE NONAPOPTOTIC THE SURE WE WOULD BE READY IN TIME AND YOU KNOW WE PUT THAT CONTRACT INTO PLACE EARLIER. WE WERE WORRIED ABOUT USING OUR CLINICAL TESTING ORIGINALLY FOR SUPPLY CHAIN ISSUES AND YOU KNOW WE HAD ARRANGE WIDE LABCORP TO DO OUR ORIGINAL SET OF STUDENTS ON ARRIVAL. NOW WE'RE A LOT CLOSER TO FEELING THAT OUR IN-HOUSE TESTING WILL BE, YOU KNOW READY FOR PRIME TIME BUT WE'RE WORKING VERY AT A VERY FAST PACE HERE TRYING TO GET THINGS READY BECAUSE OUR STUDENTS--OUR FIRST YEAR STUDENTS ARRIVE AUGUST 10th AND THEN THE FULL STUDENT BODY BY AUGUST 17th SO WE'RE VERY EARLY AMONG OUR PEERS IN THE START OF THE SCHOOL YEAR. >> DR. FESER HAS A QUESTION. >> MAY I JUST ASK IF PERHAPS ADMIRAL GIROIR OR PROVOST KORNBLUTH, USING TECHNOLOGIES THAT ARE UNDER DEVELOPMENT, RAPID DEVELOPMENT DO YOU RECOMMEND USING THOSE FOR SURVEILLANCE TESTINGAs LONG AS THE POSITIVES ARE DIRECTED TO GET A CLEA-CERTIFIED TEST? >> SO BRETT GIROIR HERE, SO THE REGULATORY ANSWER AND I WILL CLARIFY THIS BUT I AM LEGALLY IN CHARGE OF THE FDA AND THE CDC FOR TESTING, NOT THAT I WANT TO BE BUT I AM. THAT SURVEILLANCE TEST SUGGEST A NONFDA RELATED FIELD AS LONG AS YOU'RE NOT SUPPLYING THAT RESULT TO A PERSON. THERE IS OFTEN BARRIERS FOR EUAs THAT HAVE NOTHING TO DO WITH THE SCIENCE AND VALIDATION, IT MAY ACTUALLY, YOU KNOW BE RELATED TO A COMPANY'S WANTING IMMUNITY FROM LIABILITY FOR A VARIETY OF THINGS. SO I WOULD SAY GUARDEDLY, IF YOU ARE A GOOD INSTITUTION AND YOU HAVE A QUOTE-UNAUTHORIZED PLATFORM BUT YOU HAVE SCIENTIFICALLY VALIDATED IT WITHIN YOUR INSTITUTION, GO FOR IT, RIGHT? IT DOESN'T HAVE TO BE AUTHORIZE INDEED A SURVEILLANCE ENVIRONMENT BUT OBVIOUSLY IN A DIAGNOSTIC ENVIRONMENT, IT MUST BE AN AUTHORIZED OR APPROVED TEST IN A CLEA ENVIRONMENT. HOPEFULLY THAT ANSWERS THAT AND I THINK I SAW OTHER HEADS SHAKING ABOUT THAT IN OTHER INSTITUTIONS. >> THANK YOU. VERY HELPFUL. >> OKAY, YOU HEARD IT HERE. WE NEED TO HEAR OUR LAST 2 PANELISTS SO NEXT WE HAVE PRESIDENT HAVIDAN RODRIGUEZ, PRESIDENT OF SUNY AT ALBANY. >> THANK YOU VERY MUCH, I'M PROUD TO REPRESENT THE UNIVERSITY AT ALBANY, A PUBLIC 1 RESEARCH INSTITUTION. [AUDIO CUTS OUT ]--DIVERSE RESEARCH CAMPUSES IN THE NATION WITH NEARLY 40% OF OUR UNDERGRADUATE STUDENTS IDENTIFIED AS UNDERREPRESENTED MINORITY STUDENTS IN A HIGH PROPORTION OF FIRST GENERATION AND LOW INCOME STUDENTS. I CONTINUE TO REMIND FOLKS AT OUR INSTITUTION THAT WE CANNOT LOSE SITE OF THE FACT THAT WE'RE STILL IN THE MIDST OF A GLOBAL PANDEMIC THAT HAS RESULT INDEED AN EXTRAORDINARY AMOUNT OF DEATHS, EXTENSIVE HUMAN SUFFERING AND AN UNTOLD ECONOMIC IMPACT ACROSS THE GLOBE. ONE MONTH FROM TODAY, THE UNIVERSITY AT ALBANY IS PLANNING ON WELCOMING STUDENTS TO BE BACK ON CAMPUS AND FALL CLASSES WILL BEGIN ALBEIT VERY DIFFERENTLY FROM WHAT WE ALL ARE ACCUSTOMED TO. FORTUNATELY THANKS TO AGGRESSIVE MITIGATION STRATEGIES AND LARGE SCALE TESTING AND TRACING, NEW YORK STATE HAS DRAMATICALLY REDUCED OR CONTAINED THE SPREAD OF THE VIRUS. ALBANY IS ALSO REQUIRING STUDENTS TO PROVIDE DOCUMENTATION OF A NEGATIVE PC R TEST AND THEY SHOULD HAVE A QUARANTINE PERIOD OF 14 DAYS BEFORE ARRIVAL ON CAMPUS. ALSO, IN ADDITION TO BEING TESTED, ALL STUDENTS ARRIVING FROM STATES, DESIGNATED UNDER NEW YORK'S TRAVEL ADVISORY OR FROM COUNTRIES DESIGNATED UNDER CDC'S LEVEL 3 TRAVEL ADVISORY MUST SELF-QUARANTINE FOR 14 DAYS UPON ARRIVAL IN NEW YORK STATE. COMBINED WITH PLANS FOR EVENT AND POOL TESTING AND ROBUST SYMPTOM SURVEILLANCE WE BELIEVE THIS WILL BE THE MOST EFFECTIVE APPROACH FOR OUR CAMPUS COMMUNITY TODAY. HOWEVER, AS DR. DAVID HOLGRAVE OUR DEAN OF THE SCHOOL OF PUBLIC HEALTH HAS STATED, AS THE PANDEMIC RAGES ON IN OTHER STATES PUSHING NATIONAL TESTING CAPACITY TO THE LIMIT AND MANY UNIVERSITIES IMPLEMENT TESTING REQUIREMENTSA THE ESSENTIALLY THE SAME TIME, IT IS REASONABLE TO ASSUME THAT OUR NATIONAL TESTING CAPACITY CHALLENGES WILL BE EXACERBATED IN THE COMING WEEKS JUST WHEN WE NEED THEM MOST. NEW ALBANY HAS HAD SIGNIFICANT ACADEM AND I CAN RESEARCH EXPERTISE RELATED TO THE PANDEMIC THANKS TO OUR SCHOOL OF PUBLIC HEALTH, THE COLLEGE OF EMERGENCY PREPAREDNESS, HOMELAND SECURITY AND CYBERSECURITY AND THE SCHOOL OF PUBLIC SOCIAL WELFARE AMONG OTHERS. ALSO, BECAUSE OF OUR NATIONAL LEADERSHIP IN THE AREA OF MINORITY HEALTH DISPARITIES, NEW ALBANY WAS COMMISSIONED BY GOVERNOR CUOMO TO LEAD THE DISPROPORTIONATE IMPACT ON COMMUNITIES OF COLOR ON COVID-19 AND AS WE ALL KNOW MINORITY HEALTH DISPARITY IS A NATIONAL PUBLIC HEALTH CRISIS, OUR CAMPUS AND WITH THOUSANDS OF PC R TESTS HAVE BEEN ADMINISTERED SINCE APRIL, HOWEVER, THE CAPACITY FOR THE UNIVERSITY AT ALBANY TO PROVIDE ITS OWN TESTING IS A VERY DIFFERENT MATTER. OUR RNA INSTITUTE IS ENGAGED IN TESTING FROM A RESEARCH STANDPOINT, AND HAS TREMENDOUS STRENGTHS WITH LEADING EXPERTS AND VIRAL BIOLOGY. WE HAVE ONGOING RESEARCH ON COVID-19, THE ABILITY TO PERFORM PC R ANALYSIS AND EXPERTISE TO CONDUCT REALTIME DATA ANALYSIS SAMPLE TRACKING AND MODELING FOR SURVEILLANCE, HOWEVER, WE LACK THE CAPACITY TO ACQUIRE, CAN DO AND PROCESS THOUSANDS OF SAMPLES OF AT THE TIMING AS WELL AS ANALYSIS AFTER SCREENING AND WE LACK ON-HAND SAMPLING MATERIALS AND TESTING SUPPLIES AND NO SECURE PIPELINE TO INSURE A CONTINUOUS SUPPLY AMONG OTHER LIMITATIONS. ALTHOUGH, OUR ACADEMIC AND CLINICAL RESEARCH LABS HAVE SUG95 CANT CAPACITY TO BECOME--SIGNIFICANT CAPACITY TO BECOME A POINT OF SERVICE TESTING LOCATIONS FOR STUDENTS AND EMPLOYEES, SIGNIFICANT INVESTMENTS ARE NECESSARY. BECAUSE OF THE POTENTIAL SPREAD OF VIRUS, PERHAPS NIH WILL CONSIDER PROVIDING TESTING SUPPORT TO INSTITUTIONS OF HIGHER EDUCATION, THAT SAID THE UNIVERSITY AT ALBANY IS IN A STRONG POSITION TO SUPPORT CONTACT TRACING. WE ARE CREATING A CONTACT SUPPORT TEAM THAT COULD ALSO BE A STRONG ASSET IN SUPPORT OF COUNTY AND STATE CONTACT TRACING EFFORTS. TO CONCLUDE WHEN IT COMES TO HIGHER EDUCATION'S RESOURCES AROUND TESTING AND SURVEILLANCE AS WE HAVE HEARD THIS AFTERNOON, I BELIEVE OUR INSTITUTIONS COLLECTIVELY REPRESENT A DIVERSE ECOSYSTEM OF RESOURCES THAT WILL CONTINUE TO HELP IN THE FIGHT AGAINST COVID-19, HOWEVER, WE HAVE ALSO EXPERIENCED UNPRECEDENTED FINANCIAL CHALLENGES DUE TO THE PANDEMIC CONSEQUENTLY, HIGHER EDUCATION WILL REQUIRE SIGNIFICANT INVESTMENTS AT THE FEDERAL LEVEL. FINALLY, IN ADDITION TO TESTING AND SURVEILLANCE--[ AUDIO CUTS OUT ]--COMPASSION AND INNOVATION. AGAIN THANK YOU SO MUCH FOR THE INVITATION. NTHANK YOU FOR THOSE STIRRING WORDS, CERTAINLY, YEAH, INTERDEPENDENCE THAT'S PART OF WHAT WE'RE TALKING ABOUT HERE THIS AFTERNOON. WELL WE SEEM TO HAVE CALIFORNIA BOOK-INS ON OUR PANEL HERE. WE STARTED WITH UNIVERSITY OF CALIFORNIA, WITH DR. BYINGTON AND NOW SANDRA BROWN. DR. BROWN IS THE VICE CHANCELLOR FOR RESEARCH AT UC SAN DIEGO, SO DR. BROWN? >> THANK YOU VERY MUCH, DR. COLLYNNS AND ADMIRAL GIROIR FOR THIS OPPORTUNITY TO PARTICIPATE IN THIS IMPORTANT ROUND TABLE. I THOUGHT I WOULD DO 3 THINGS IN MY LIMITED TIME, SHARE RELEVANT COVID-19 EXPERIENCES AND THE LESSONS LEARNED FROM OUR UNIVERSITY PILOT STUDY AND OUR PLAN. SECONDLY DESCRIBE THE TESTING DEVELOPMENT APPROACH THAT WE HAVE HERE AT UCC SAN DIEGO AND FINALLY MENTION THE COLLABORATIVE FRAMEWORK THAT UC SAN DIEGO HAS TAKEN WITH THE COMMUNITY BECAUSE WHATEVER WE FIND ON CAMPUS THESE FINDINGS CAN BE ACCELERATED IN THE COMMUNITY IN COMMUNITY SCHOOLS AND OTHER SETTINGS, IF WE ALREADY HAVE A WELL ESTABLISHED RELATIONSHIP. SO FIRST, UNDER THE LEADERSHIP OF CHANCELLOR PURDEEP, UC SAN DIEGO WAS 1 OF THE FIRST TO DEVELOP A COMPREHENSIVE PLAN FOR BOTH SURVEILLANCE AND TESTING THAT'S NEEDED TO BRING OUR STUDENTS BA BEING THIS FALL. WE CALL THIS PLAN RETURN TO LEARN. IT'S A CAMPUS WIDE PROGRAM TO ALLOW TEACHING--EXCUSE ME TEACHING, LEARNING AND RESEARCH TO RESUME ON CAMPUS WHILE SUPPORTING HEALTH AND SAFETY OF OUR 40,000 STUDENT COMMUNITY. IN ADDITION, IT INVOLVES MULTIPLE TASK FORCES WORKING TOGETHER, THESE ARE CROSS CAMPUS TASK FORCES GUIDED BY EVIDENCE, SCIENCE AND THE EXPERTISE OF OUR FACULTY AND RESEARCHERS FROM THE SCHOOL OF MEDICINE, OUR SCHOOL OF PUBLIC HEALTH AND LONGEVITY SCIENCE AND THE HEALTHCARE EXPERTS HERE AT UC SAN DIEGO IN CONJUNCTION WITH STATE ASK COUNTY HEALTH GUIDELINES. SO A MAJOR COMPONENT OF THE RETURN TO LEARN IS THE FOCUS ON OUR TESTING. WE USE STATISTICAL MODELING TO DESIGN AND MODIFY THE SURVEILLANCE TESTING AND CONTACT TRACING TO PLAN TO MAXIMIZE EARLY DETECTION AND SHORTEN THE DURATION OF ANY POTENTIAL OUTBREAK ON CAMPUS AND BASED ON THE MODELING OF NATASHA MARTIN AND OUR INFECTIOUS DISEASE EXPERT CHIP SCHOOLY THE CURRENT PLAN WHICH IS FLEXIBLE UP TO THE TIME THAT STUDENTS COME TO OUR CAMPUS IN SEPTEMBER IS TO TEST UP TO 70% OF THE STUDENTS ONCE PER MONTH TO INSURE WE CAN DIAGNOSE AND CONTACT TRACE THOSE WHO ARE EXPOSED QUICKLY ENOUGH TO PREVENT ANY MAJOR OUTBREAK ON CAMPUS, ANY OUTBREAK GREATER THAN A FEW INDIVIDUALS. SO WE CONDUCTED A STUDENT PILOT PHASE FOR THIS PROGRAM, LAUNCHED IT MAY 11th DURING WHICH OVER A 3 WEEK PERIOD OVER 1500 RESIDENT UNDERGRADUATE AND GRADUATE STUDENTS TOOK PART IN A SELF-ADMINISTERED COVID-19 TESTING. THE SCREENINGS WERE COMPLETED THROUGH A CONVENIENT VOLUNTARY SELF-ADMINISTERED SWAB TEST, CHEEK SWAB TEST AND ANALYZED THROUGH OUR CLEA CERTIFIED LAB THAT'S RUN FOR PROFESSOR GONIUS, THROUGH THIS PILOT UC SD DEVELOPED AN INFRASTRUCTURE THAT WILL BE CRITICAL TO THE SUCCESS FOR ANY SCHOOL-BASED PROGRAM IN THE FALL. SURVEILLANCE, TESTING, INFORMATICS DYNAMIC MODELING, CRITICAL COMMUNICATION AND THE BEHAVIORIAL MONITORING SYSTEMS THAT ARE NEEDED. WE HAVE A COUPLE OF TAKE AWAY MESSAGES FROM THAT PHASE 1 PILOT STUDY. AND I THINK THEY ARE THAT SELF-ADMINISTERED TESTING FOR STUDENTS IS POSSIBLE, SURVEILLANCE DIAGNOSTICS AND CAMPUS BASED CONTACT TRACING CAN BE DONE VERY QUICKLY BUT THERE ARE ALSO IMPORTANT LESSONS LEARNED ABOUT SOME OF THE CHALLENGES THAT OUR CAMPUS AND MANY OTHER CAMPUSES WILL FACE. FIRST AND FOREMOST, THERE IS A NEED FOR DISTINCTIVELY TAILORED COMMUNICATION THAT'S DIFFERENT FOR STUDENTS AND FACULTY AND STAFF. THE TESTING IS ONLY 1 PART OF AN INTEGRATED SYSTEM, THE BEHAVIORIAL HEALTH SAFETY DATABASE INFORMATION CYBER FLOW AND CYBERSECURITY ARE ALL PART OF THAT AND THEN A FAILURE IN ANY 1 OF THOSE DEPLETES THE VALUE OF SURVEILLANCE AND TESTING AND THEN FINALLY, LINKING PUBLIC HEALTH MODELS WITH BASIC BIOMEDICAL SCIENCE CAN ACCELERATE PROGRESS IN THE PATHWAYS TO OPEN OUR EDUCATIONAL SYSTEM. SO A VERY SPECIFICALLY ABOUT--[AUDIO CUTS OUT ]--JUST A GREAT ACRONYM. RAMP UP PLAN INCORPORATED TRADITIONAL COMMERCIAL PLATFORMS TO BUILD THE CAPACITY FOR CLEA-LEVEL TESTING AND WE'RE USING MULTIPLE PLATFORMS SIMULTANEOUSLY TO MITIGATE THE RISK FROM SUPPLY CHAIN DISRUPTIONS, WHICH HAVE ALREADY BEEN REFERRED TO HERE. THIS PROGRAM IS NOW EXPANDING CAPACITY FURTHER AND HAS VALIDATED, POOLED TESTERRING UNDER AN EUA AS ALREADY BEEN REFERRED TO. WE'RE CURRENTLY REDEPLOYING A HIGH THROUGH PUT CAMPUS BASED ACADEMIC RESEARCH LABORATORY. THIS LAB PREVIOUSLY FOCUSED ON THE MICROBIOME, IT'S ROB KNIGHT LAB, SHIFTED TO HIGH THROUGH PUT SARS-COV-2 SCREENING USING MINIATURIZED PC R PLATFORM. THIS WILL BE COVERED BY AN EXTENSION OF A CLEA LICENSE TO EXTEND IT IS TESTING CAPACITY AND PROVIDE SOME REDUNDANCY SHOULD THE CLEA-TESTING BASED ON XECIAL REAGENTS BE CHALLENGED BY THE SUPPLY LIMITATIONS OR REDIRECTION OF TESTING FOR PUBLIC HEALTH PURPOSES. SOME OF THE LARGE LABORATORIES, QUEST, LABCORP, ET CETERA ARE BECOMING INCREASINGLY CHALLENGED TO PROVIDE THE RAPID TURN AROUND THAT ARE NEEDED FOR TESTS. AND THEN A THIRD, OUR BASIC SCIENCE COMMUNITY ON CAMPUS AND DEVELOPING A NUMBER OF NOVEL APPROACHES TO TESTING, LAMP-CASCRSPR TECHNOLOGIES THAT WILL BE BROUGHT INTO THE LAB RAARE TOYS DESCRIBED ABOVE UNDER CLEA SO THEY CAN BE OPTIMIZED AND VALIDATED AND BOTH CELL AND ANIMAL BSL FACILITIES WILL HELP US CONTINUE TO MOVE FORWARD IN SOME OF THESE DIRECTIONS. AND FINALLY, THE FOURTH COMPONENT OF THE TESTING IS THAT WE'VE DEVELOPED SIMPLIFIED, HIGHLY SCALABLE SELF-TESTING APPROACHES THAT ENABLE HIGH VOLUME SCREENING OF ASYMPTOMATIC STUDENTS FACULTY AND STAFF ISSUES IMPORTANTLY WITHOUT THE NEED FOR PPE CONSUMABLES THAT WILL ENABLE US TO DETECT EARLY EVIDENCE OF VIRAL ACTIVITY ON CAMPUS BEFORE SYMPTOMATIC INDIVIDUALS REACH OUR HEALTHCARE SYSTEM. AND ALL OF THIS IS PART OF A SYSTEM INCLUDING DAILY AND ONLINE SCREENING, CORE BEHAVIORIAL SAFETY PROTOCOLS, MASKING, HAND WASHING, DISTANCING, ET CETERA. CAMPUS BASED CONTACT TRACING AND INFORMATICS TO SHARE THAT INFORMATION IN REALTIME FOR EDUCATION AND POLICY DECISION MAKING. SO THE THIRD POINT I WANTED TO MAKE IS THAT UC SAN DIEGO I THINK HAS INCLUDED 1 OTHER CONOPPOSITE BEHAVIORIAL PHENOTYPENT AND THAT'S THAT WE'VE BEEN VERY FORWARD LEANING IN CRITICAL PUBLIC HEALTH SERVICE SINCE THE OUTSET OF THE PANDEMIC AND THAT IS BY DESIGN. WE'RE WORKING CLOSELY WITH OUR LOCAL COMMUNITIES TO RESPOND TO THE PANDEMIC, SO THAT AS MEDICINES AND VACCINES ARE DEVELOPED AND OTHER INNOVATIONS UNFOLD, WE WILL BE ABLE TO FACILITATE THE UPTAKE OF THESE NEW INNOVATIONS IN OUR COMMUNITY. JUST EXAMPLES INCLUDE PROVIDING PPE TO THE HEALTHCARE SYSTEM, DEVELOPING INNOVATIONS IN VENTILATORS SO THAT MULTIPLE PATIENTS CAN USE THEM SIMULTANEOUSLY. PARTNERING WITH INDUSTRY GOVERNMENT ON MEDICATION AND VACCINE DEVELOPMENT OF COURSE, BUT ALSO INNOVATIONS AND EFFICIENCIES IN--FOR PC R TESTING, NOVEL WASTE WATER ASSESSMENT AS WELL AS OTHER ENVIRONMENTAL SURFACE AND AIR SAMPLING TO HELP US STREAMLINE THE ENVIRONMENTS IN WHICH WE NEED TO USE CLEA TESTING AND WE FORMED AN ADVISORY COMMITTEE THAT IS WORKING TO HELP THE 110,000 STUDENTS SAN DIEGO UNIFIED SCHOOL DISTRICT. SO IT'S IMPORTANT TO MENTION IN CLOSING THAT THESE ACTIONS ALL REQUIRE RESOURCES AND FUNDING. THERE HAVE BEEN STRONG COMMITMENTS FROM OUR CAMPUSES. UNIVERSITIES ARE ALREADY SEVERELY IMPACTED BIEW TO THE CORONAVIRUS AND--BUT AS A PUBLIC RESEARCH UNIVERSITY, WE BRING TO THE COMMUNITY AND THE NATION WE THINK NOT JUST TECHNICAL ABILITIES IN ADVANCES BUT INNOVATIVE CAPABILITIES THAT THROUGH THE SERVICE COMMITMENT CAN HELP WITH THE DEPLOYMENT OF NEW MEDICINES AND TECHNOLOGIES IN THE COMMUNITY. >> THANK YOU. >> THANK YOU. I KNOW WE'RE BUMPING UP AGAINST OUR TIME LIMIT. I DID WANT TO ASK, HAS THIS BEEN REALLY USEFUL FOR ME TO HEAR FROM ALL OF YOU--[AUDIO CUTS OUT ]--LEARN FROM EACH OTHER, WHAT INSTITUTIONS ARE TRYING WHICH APPROACHES, AND BEST PRACTICES CAN BE WIDELY ADOPTED, THAT NETWORKING IS AT ALREADY KIND OF HAPPENING THERE? OKAY, I SEE NODDING HEADS, THAT WOULD BE GOOD. BECAUSE I CAN SEE THERE'S A LOT OF INVENTIVENESS THAT'S FOLDING INTO WHAT YOUR INSTITUTIONS ARE DOING AND YOU WOULD WANT THEM--THOSE OPPORTUNITIES TO BE WIDELY APPRECIATED AND PERHAPS ADOPTED AND EXPORTED AND IF THERE'S SOMETHING WE CAN DO TO HELP WITH THAT, I'M SORT OF THINKING, 1 OF THE THINGS WE TALKED ABOUT WAS THE NEED FOR A SURVEILLANCE CAPACITY WHICH MEANS YOU'RE NOT CONTRACTING WITH QUEST AND LABCORP WHICH WILL MAKE YOU AND EVERYBODY ELSE VERY UNHAPPY FOR LARGE SCALE SURVEILLANCE SCREENING. THERE ARE VARIOUS WAYS TO DO THAT, ADMIRAL GIROIR MENTIONED ADDED THE OUTSET MANY OF YOU HAVE ABI 7500 MACHINES THAT COULD BE BROUGHT TO BEAR OR NEXT GEN SEQUENCING MACHINES OR OTHERS BUT MANY INSTITUTIONS WOULD LOVE TO HAVE A HERE'S HOW YOU DO IT PACKAGE TO SAY, HOW DO YOU TAKE AN ACADEMIC LAB THAT HAS THAT KIND OF INSTRUMENTATION AND TURN IT INTO A RELIABLE PLACE WHERE YOU ARE NOT GOING TO MIX UP SAMPLES BECAUSE YOU HAVE TO HAVE A LENS SYSTEM AS WELL TO KEEP TRACK OF THINGS. WITH THAT KIND OF THING HAPPENING ALREADY IN TERMS OF SHARING THOSE EXPERIENCES AND PASSING UPON A HERE'S HOW TO DO IT INSTRUCTIONS TO EACH OTHER, IS THAT SOMETHING WE COULD HELP WITH? >> FRANCIS, I'LL MENTION, I THINK YOU WOULD BE REALLY PLEASED, YOU KNOW THE UNIVERSITY PRESIDENTS HAVE A NETWORK, THE PROVOST HAVE A NETWORK, THE CHIEF BUSINESS OFFICERS HAVE A NETWORK, PROTOCOL VS BEEN SHARED LIKE I'VE NEVER SEEN. THE COLLABRATIVE SPIRIT AND ENVIRONMENT IS REALLY REMARKABLE, BEFORE DATA IS PUBLISHED, TRIEWBL SHOOTING, I THINK--TROUBLE SHOOTING, I THINK THE MAIN CHALLENGES THAT PEOPLE HAVE MENTIONED HAVE BEEN PROBABLY RESOURCES AVAILABLE TO STAND SOME OF THESE THINGS UP BUT THE ACADEMIC COMMUNITY HAS REALLY BEEN COLLABORATIVE. >> AND IF WE AS WE'RE WORKING THROUGH SOME OF THESE NEW DIAGNOSTIC DEVELOPMENT IDEAS THROUGH RADX AND OTHER PURPOSES COME UP WITH SOMETHING AND THINK WOW THAT WOULD BE SOMETHING ACADEMIC INSTITUTIONS MIGHT WANT TO KNOW ABOUT, IS THERE A WAY TO FEED INTO THOSE NETWORKS? DO WE GO THROUGH YOUR ORGANIZATIONS? OR WHAT IS THE PLAN TO MAKE SURE WE DON'T MILSZ THE BOAT? --MISS THE BOAT? >> WELL JUST TO FOLLOW ON THAT STRUCTURE, YOU KNOW DOUBLE AAMC HAS LINE OF SIGHT TO THE DEANS OF ALL THE ACADEMIC PROGRAMS THE AU AS YOU MENTIONED MANY OF THE UNIVERSITIES AND OTHERS MAY HAVE OTHER SUGGESTIONS ABOUT YOU KNOW NETWORKS THAT ARE PREEXISTING, FDA, AND THE HOSPITAL ASSOCIATION. >> I THINK THE APLU PER PUBLICS IS PARTICULARLY IMPORTANT IN A GREAT NETWORK TO DISSIMINATE THIS INFORMATION. >> WELL WE HAVE GOOD CONNECTION THERE IS, I WANT TO BE SURE THAT WE'RE NOT MISSING SOME OTHER KIND OF NETWORK FOR PASSING ALONG NEW IDEAS ABOUT DOING SURVEILLANCE TEST NOTHING PARTICULAR. >> BRETT ARE THERE THINGS YOU WANT TO SAY BY WAY OF CLOSURE BECAUSE I KNOW WE'RE COMING UP AGAINST TIME IN FACT, WE'VE SLIGHTLY PASSED IT BUT IT WAS SUCH A WEALTH OF INFORMATION, I WISH WE COULD GO ON ON LONGER BUT I THINK PEOPLE HAVE THINGS THEY NEED TO DO. ADMIRAL GIROIR? >> NO, I JUST WANT TO THANK YOU FRANCIS FOR ORGANIZING THIS, THERE'S A WEALTH OF INFORMATION. BOTH TAMMY BECKHAM AND I AS YOU DO, ANSWER OUR OWN E-MAIL, AND WE WOULD BE DELIGHTED TO ASSIST OR TO PROVIDE ANY INFORMATION, YOU KNOW WE CAN. AGAIN, I DO WANT TO URGE TO THE DEGREE POSSIBLE NOT TO USE THE LAB CORP AND QUEST OF THE WORLD BECAUSE YOU KNOW THEY ARE A VITAL RESOURCE FOR PLACES THAT DO NOT HAVE THE KIND OF CAPACITY THAT THE INSTITUTIONS WERE TALKING TO TODAY AND IT WILL GET TO A POINT BECAUSE THERE'S A LIMITATION EVEN MONTH THEM WHO ARE DOING OVER 400,000 TESTERS A DAY IN THOSE ACLA LABS. YOU WILL BUMP UP THAT LIMIT AND YOU KNOW YOU WILL DEFEAT YOUR OWN PURPOSES FOR HAVING A TEST IF YOU HAVE TO WAIT 7 DAYS OR 2 WEEKS TO GET THAT TEST. SO, YOU KNOW I THINK WE ALL ACKNOWLEDGE THAT AND YOU ACKNOWLEDGE WHERE WE ARE FROM A PUBLIC HEALTH STANDPOINT BUT I WOULD BE DELIGHTED TO WORK WITH ANY OF YOU AT ANY TIME, YOUR SYSTEMS, TAMMY BECKHAM AS WELL, EVEN FOR THINGS LIKE PROJECTING, YOU KNOW, AM I GOING TO HAVE ENOUGH SUPPLYS ON PANTHER TO RUN THIS? I CAN TELL YOU NOW, YOU'RE NOT, BUT WE KNOW EXACTLY WHAT THE SUPPLY CHAINS LOOK LIKE, WHERE THEY'RE LIKELY TO GO, WHAT SYSTEMS YOU CAN RELY ON, WHERE THERE'S GOING TO BE GIVE, WHERE WE'RE DOING INVESTMENT AND TO THE DEGREE WE CAN HELP PLAN OR HAVE ANOTHER JOINT CALL WE'RE HAPPY TO DO MA AND AGAIN, THANK YOU FRANCIS FOR THE OPPORTUNITY. >> WELL, I SUSPECT, I KNOW WE HAD MORE THAN 500 PEOPLE LISTENING AND I WISH WE COULD HAVE TAKEN QUESTIONS FROM ALL OF THEM AND GOTTEN OBSERVATIONS AND INSIGHTS--[AUDIO CUTS OUT ]--NOT JUST MONEY, BUT ALSO EXPERTISE ABOUT TESTING SURVEILLANCE, REGULATORY ISSUES, COORDINATION ISSUES. YEAH MY E-MAIL IS EASY TO FIND, FRANCIS.COLLINS @NIH.GOV, PUT IN THE SUBJECT LINE UNIVERSITY TESTING SO I PULL THESE TOGETHER IN 1 PLACE. UNIVERSITY TESTING IS THE SUBJECT. SEND ME YOUR IDEAS AND LET'S SEE WRA WE CAN DO HERE--WHATTA WE CAN DO HERE. WE CAN'T DO A SURVEY BECAUSE THAT WOULD RUN INTO THE PAPERWORK REDUCTION ACT AND WE WOULD HAVE TO GO TO PRA JAIL AND THAT WOULD BE REALLY BAD BUT I THINK I CAN SOLICIT YOU TO SEND ME E-MAILS, BE GENTLE OF COURSE, IMAGINE THIS COULD BE PRETTY OVERWHELMING, SO YEAH, SOMETHING YOU THINK IS CLEARLY A STEP FORWARD THAT I NEED TO KNOW ABOUT, SEND ME A NOTE. THIS HAS BEEN REALLY HELPFUL YOU ALL AND THANK YOU TO ALL THOSE WHO LOGGED IN THROUGH THE VBRIC WEBSITE AND I ABLE TO WATCH THE CONVERSATION BUT PANELISTS YOU HAVE BEEN WONDERFUL. IT'S A WONDERFUL DIVERSITY HAVE YOU FROM YOUR DIFFERENT INSTITUTIONS AS WELL ABOUT WHAT YOU ARE TRYING TO DO. I GET THE SENSE OF HOW YOU ARE REALLY ALL-IN HERE IN BRINGING THE RESOURCES AND TALENTS OF YOUR PEOPLE EVEN IN THE FACE OF DIFFICULT FINANCIAL CIRCUMSTANCES AND HOW YOU'RE ALSO REACHING OUTED BEYOND THE WALLS EVER A UNIVERSITY TO HELP YOUR COMMUNITIES AND INSTITUTIONS IN YOUR VISITINGINIT THAT MAY NOT BE IN A GOOD PLACE TO DO THIS THEMSELVES. THAT'S WHAT THE AMERICAN UNIVERSITY IS ALL ABOUT. AND YOU ALL REPRESENT IT REALLY WELL. SO THANK YOU. WE ARE GOING TO GET THROUGH THIS AND WE WILL GET THROUGH IT BETTER IF WE DO ALTOGETHER. WITH THAT I WILL SAY THANK YOU EVERYBODY AND IF YOU ARE 1 OF THOSE FOR WHOM A WEEKEND STILL MEANS EVERYTHING, I HOPE YOU HAVE A GOOD WEEKEND. [LAUGHTER] >> THANK YOU DR. COLLINS.