NVAC Meeting: June 5, 2019: Presentations on Antibiotic-Resistant


>>ALL RIGHT, OUR NEXT SESSION IS AN UPDATE
ON THE U.S. NATIONAL ACTION PLAN FOR COMBATING ASPECT BIOTICS REIS H*F-FOR PLANNING AND EVALUATION
AT HHS. SHE’S ALSO THE COCHAIR FOR THE CARB TASK FORCE.
SHE WILL GIVE US AN UPDATE ON THE NATIONAL ACTION PLAN FOR COMBATING ANTIBIOTIC RESIFT
APT BACTERIAER WHY. –BACTERIA.
>>THANKS. SO AGAIN, I AM ONE OF THREE CO CHAIRS FOR
THE NATIONAL–SORRY FOR THE FEDERAL TASK FORCE ON COMBATING ANTIBIOTIC RESISTANT BACTERIAER
WAAND I AM EXCITED TO BE HERE AND PRESENT TO YOU GUYS AND PLEASE STOP ME IF YOU HAVE
ANY QUESTIONS AS I’M GOING THROUGH THE PRESENTATION. I’M HAPPY TO ANSWER.
SO I THINK MOST PEOPLE ARE PROBABLY FAMILIAR THAT ANTIBIOTIC RESISTANCE IS AN ISSUE.
YOU KNOW WE HAVE AT LEAST 2 MILLION ILLNESSES AIER THAT ARE RESISTANT TO BACTERIA FROM THE
2013 CDC THREAT REPORT, WE KNOW THAT APPROXIMATELY 23,000 DEATHS ARE ATTRIBUTABLE TO RESISTANT
INFECT TPEBGZS AND THAT’S PROBABLY A CONSERVATIVE ESTIMATE AND WE ULS KNOW THAT AS BACTERIA
DEVELOPED, NEW WAYS TO RESISTANT ANTIBIOTICS WE ACTUALLY LOSE THE WAYS WE HAVE TO TREAT
THEM. SO IN 2014 THE PREVIOUS ADMINISTRATION PUBLISHED
AN EXECUTIVE ORD THEY’RE CREATED TWO NEW GROUPS. ONE WAS THE FEDERAL TASK FORCE FORCOMBATTING
ANTIBI ATTIC RESISTANT BACTERIA AND THAT TASK FORCE IS CO-CHAIRED BY HHS AND I’M THE CO
CHAIR AND THEN UNITED STATES DEPARTMENT OF AGRICULTURE AND THE DEPARTMENT OF DEFENSE.
SO WOY HAVE THREE CAREER OFFICIALS THAT CO CHAIRS FOR THE TASK FORCE AND CO-WORKERS WO,
WITH, I THINK APPROXIMATELY 17 DEPARTMENTS AND AGENCIES.
YOU WILL SEE THE PICTURE NEXT. BUT THE OTHER THING THAT THAT EXECUTIVE ORDER
DID WAS CREATE THE IMPETUS FOR CREATING A NATIONAL ACTION PLAN TO COMBAT ANTIBIOTIC
RESISTANT BACTERIA AND THESE ARE THE GOALS FOR THE EMERGENCE OF THE BACTERIA AND PRESREBT
INFECTION SO THAT’S ABOUT INFECTION PREVENTION, CONTROL AND STEWARDSHIP, STRENGTHENING NATION
ALEXANDER HEALTH EFFORTS TO COMBAT RESISTANCE SO THERE’S A LOT OF INFORMATION AND GOAL TWO
ABOUT SURVEILLANCE AND DATA, ADVANCING THE DEVELOPMENT AND USE OF RAPID INNOVATIVE DIAGNOSTIC
TESTS FOR IDENTIFICATION AND CHARACTERIZATION OF RESISTANT BACTERIA AND ACCELERATING RESISTANT
DEVELOPMENT FOR NEW THERAPEUTICS AND DRUGS AND VACCINES AND THEN ISSUES THE LAST GOAL
IS FOCUSED ON TKPWRAGZ SALIVA–SALIVA COLLABORATION BECAUSE THIS IS VERY MUCH A GLOBAL ISSUE.
SO THESE ARE ALL THE AGENCIES THAT ARE INVOLVED AND YOU KNOW YOU SEE THE HHS FAMILY THERE
IN THE MIDDLE. WE, I THINK HAD THE BIGGEST PORTFOLIO, CERTAINLY
ON THE HUMAN SIDE OF ANTIBIOTIC RESISTANCE, USDA AND FDA REALLY WORK ON THE ANIMAL SIDE
AND THEN D.O.D. HAS QUIT A LARGE PORTFOLIO RELATED TO HUMAN ANTIBIOTIC RESISTANCE AND
THEN THERE’S A WHOLE HOST OF OTHER AGENCIES THAT ARE PART OF THE TASK FORCE THAT WE MANAGE.
SO, IN ADDITION TO THE TASK FORCE AS I MENTIONED THAT EXECUTIVE ORDER CREATED TWO GROUPS.
THE FEDERAL TASK FORCE SO THAT IS ALL FEDS, INNERTENNAL TO GOVERNMENT, AND THEN IT ALSO
CREATED A FACA MUCH LIKE YOURS THAT WE CALL THE PRESIDENTIAL ADVISORY COUNCIL ON COMBATING
ANTIBI ATTIC RESISTANT BACTERIA ALSO CAME OUT OF THE SAME GROUP HERE IN HHS.
AND THEY ARE SAME AS YOU, A GROUP OF NONGOVERNMENT EXPERTS, GIVING US ADVICE ON ANTIBIOTIC RESISTANCE
TO SECRETARY. THEY ARE ABOUT TO GIVE US A REPORT ON WHAT
WE SHOULD BE DOING FOR THE NEXT NATIONAL ACTION PLAN.
SO WE ARE AS A TASK FORCE, THE FEDERAL TASK FORCE IMPLEMENTING THE NATIONAL ACTION PLAN
SO WE MENTIONED THERE ARE FIVE GOALS, THERE ARE SOMETHING LIKE 350 MILESTONES IN THAT
PLAN. IT IS A VERY DENSE PLAN, THERE’S A LOT OF
ACTIVITY IN THAT PLAN, AGAIN, CO CHAIRED BY SECRETARIES OF HHS, USDA IS D.O.D. AND ASPE,
THAT’S THE OFFICE WHERE I SIT IS THE HHS LEADS THE TASK FORCE.
SO WE REALLY DO FOCUS OUR EFFORTS EVEN THOUGH THEY ARE VERY VAST, WE REALLY DO TRY TO THINK
ABOUT HOW WE’RE IMPLEMENTING THE PLAN SO TRACKING THE PROBLEM AND IDENTIFYING EMERGING THREATS
AND PREVENTING INFECTIONS AND PREVENTING SPREAD OF RESISTANCE RADIOLE LOAMACYY THROUGH STEWARDSHIP
AND PREVENTION AND CONTROL EFFORTS AND THEN DEVELOPING NEW DIAGNOSTICS AND MEDICAL TREATMENTS
AND DIAGNOSTICS ARE A BIG ISSUE FOR RESISTANT BACTERIA.
WE NEED REALLY FAST DIAGNOSTICS TO TELL US WHAT KIND OF BUG IS IMPACTING PEOPLE WHEN
THEY’RE VERY SICK IN THE HOSPITAL, OFTEN DOCS DON’T KNOW EXACTLY HOW TO TREAT BECAUSE OUR
DIAGNOSTICS ARE NOT FAST ENOUGH AND THAT’S WHY WE HAVE TWO GOLES IN THE PLAN THAT ARE
SEPARATE, ONE FOR DIAGNOSTICS AND ONE FOR THERAPEUTICS.
OUR OFFICE OF GLOBAL TPAEURBGSS WITH DEPARTMENT OF USIEE, AUDIENCE ID DO COORDINATION ON AMR
RELATED EFFORTS. SO THE NATIONAL ACTION PLAN, IS IT STARTED
IN 2015 AND GOES THROUGH 2020. SO WE STARTED DEVELOPMENT OF A NEW NATIONAL
ACTION PLAN LAST YEAR WITH THE HELP OF OUR CARF, OUR FACA.
AND BASICALLY EVERY SEVERAL MONTHS, USUALLY ABOUT ONCE A YEAR, THE FACCARB IS TASKED WITH
ADVISE THE SECRETARY ON SOME KIND OF ISSUE RELATED TO ANTIBIOTIC RESIFTANCE.
THIS PARTICULAR TASK FOR THE SECRETARY WAS BASICALLY, WE ASKED THE P A C CARB TO ENGAGE
WITH PUBLIC STAKEHOLDERS TO TELL US WHAT SHOULD WE BE PUTTING IN THE NEW NATIONAL ACTION PLAN.
IT ENDS IN 2020 BUT WE SRUBSLY HAD TO START WELL BEFORE 2020 TO INSURE WE HAVE A PLAN
THAT GOES FORWARD, THE EXECUTIVE ORDER BY THE WAY DIDN’T TELL US WE HAVE TO HAVE A NEW
PLAN AND WE SEE THIS AS A PRIORITY ISSUE WITH THE DEPARTMENT AND SO WE ARE CREATING A NEW
PLAN BECAUSE WE FEEL LIKE THERE’S STILL A LOT OF WORK TO BE DONE.
SO AGAIN TELL RUN THE–THE NEW PLAN WILL RUN FROM 20-25, THE 20-25, THE JULY MEETING OF
THE PAC CARB, IT’S IN TYSON’S CORNER, VIRGINIA THAT WILL BE THE REPORT THAT’S GOING TO THE
SECRETARY THAT TELLS US WHAT IS NEW AND DIFFERENT THAT WE SHOULD BE FOCUSING ON IN THE NEXT
FIVE YEARS, IN ADDITION TO THE WORK WE ARE DOING INTERNAL TO ASSESS WHERE WE ARE AND
WHERE WE SHOULD BE GOING AND HOW WE SHOULD PRIORITIZE OUR EFFORTS.
SO WE’RE USING A LOT OF DATA POINTS TO CREATE AND DEVELOP THIS NEW NATIONAL ACTION PLAN
AS I MENTIONED, THE CURRENT PLAN IS VERY DENSE SO WE’RE GOING TO TRY TO REALLY SORT OF STREAMLINE
AND INSURE THAT WE ARE MEASURING WHAT WE’RE DOING IN A REALLY COMPREHENSIVE AND COHESIVE
WAY. WE ARE GOING TO BE VERY MUCH FOCUSING ON WHAT
THE PAC CARB TELLS US IN TERMS OF NEW AND EMERGING PRIORITY AREAS SHOULD BE.
THE GAO, GOVERNMENT ACCOUNTABILITY OFFICE AND CONDUCTING A VERY LARGE SCALE INQUIRY
ON ANTIBIOTIC RESISTANCE SO WE’RE HOPING THAT REPORT IS GOING TO BE COMING OUT TO US, I
THINK IN SEPTEMBER SO WE CAN USE THE RECOMMENDATION FROM THAT REPORT POTENTIALLY AS WELL AS CDC,
EXCUSE ME–CDC IS UPDATING THEIR THREAT REPORT, THAT THREAT REPORT CAME OUT IN 2013 AND AND
WAS A REPORT THAT SORT OF OUTLINES ALL OF THE HIGH PRIORITY PATHOGENS THAT ARE CAUSING
A LOT OF OUR RESISTANCE ISSUES. SO THIS 2019 UPDATE IS–HAS BEEN A LONG TIME
COMING. THEY’RE USING A LOT OF NEW METHODOLOGIES AND
WE’RE VERY EXCITED TO SEE THAT 2019 REPORT AND WE THINK IT WILL COME OUT PROBABLY TOWARDS
THE END OF THE YEAR SO THAT WILL BE A BIG DRIVER FOR HOW WE FOCUS OUR EFFORTS AS WELL.
SO, WE’RE GOING TO CONTINUE TO KEEP THE FRAME OF THE NEW NATIONAL ACTION PLAN, WE WILL KEEP
THOSE FIVE GOALS AS WE WE SAID WE THINK THERE’S A LOT OF WORK TO DO.
WE ARE CONDUCTING AN ASSESSMENT OF WHERE WE ARE AND HOW FAR WE COME AND WE HAVE TO DO
REPORTING EVERY YEAROT NATIONAL ACTION PLAN SO WE HAVE A COUPLE OF REPORTS ON OUR ASPE
WEBSITE, IF YOU EVER NEED SOME NOT SO LIGHT READING YOU ARE WELCOME TO DOWNLOAD THOSE
REPORTS, THEY’RE VERY DENSE BECAUSE WE HAVE REPORTS FROM–THEY ARE–THE REPORTS’RE INCLUSIVE
OF ALL OF THE DATA AND INFORMATION FROM ALL OF THE MULTIPLE AGENCIES AND UPDATES ON ALL
OF THOSE 350 MILESTONES. SO, AGAIN WE’RE GOING TO REALLILY–WE’VE ENGAGED
WITH AND ARE WORKING CLOSELY WITH OUR PAC CARB TO DETERMINE WHAT THE NEW PRIORITY SHOULD
BE AND THE PAC CARB’S REPORT WILL BASICALLY OUTLINE THREE-FIVE PRIORITY AREAS FOR THE
FIVE GOALS SO WE ARE VERY–WE’VE SEEN A DRAFT OF THE REPORT AND WE’RE VERY MUCH LOOKING
FORWARD TO GETTING THAT FINAL VERSION THIS SUMMER.
SO THIS IS JUST A TIMELINE TO TELL YOU KIND OF ALL OF THE WORK WE’RE DOING, IN SEPTEMBER,
LAST SEPTEMBER, WHEN THE PAC CARB KICKED OFF THE REPORT PROCESS, WE POSTED OUR REPORT IN
OCTOBER, THEN WE POSTED OUR FEDERAL REGISTER NOTICE FOR THE FEBRUARY MEETING FOR THE PAC
CARB TO HAVE PUBLIC STAKE HOLDER ENGAGEMENT AND AND THEN WE KICKED OFF NEW PLAN DEVELOPMENT
INTERNALLY INCLUSIVE WITH CONDUCTING THE ASSESSMENT OF WHAT’S HAPPENING WITH THE CURRENT PLAN
THAN WE HAVE AGAIN IN JULY, THAT REPORT IS DUE TO THE SECRETARY AND IN SEPTEMBER THERE’S
YOU HUMAN GENERAL ASSEMBLY, OCTOBER WE THINK THE JAO REPORT WILL BE PUBLISHED AND IN NOVEMBER,
WE WILL HAVE A DRAFT PLAN AND IN DECEMBER WE WILL HAVE OUR OWN INTERNAL GOVERNMENT AND
YOU CAN IMAGINE WILL BE BIG BECAUSE IT’S NOT JUST HHS BUT IT’S ALL OF THOSE AGENCIES THAT
HAS THE CLEAR AND THE PLAN SO THAT’S GOING TO BE QUITE A LONG PROCESS, AND THEN, IN MARCH
OF 2020 WE HOPE TO HAVE THE NEW PLAN PUBLISHED, CLEARED AND PUBLISHED AND I THINK THAT WAS
ABOUT ALL I WAS GOING TO SPEAK AND THEN I DON’T KNOW IF YOU HAVE QUESTIONS OR COMMENTS
THAT I CAN–>>THANK YOU ANY QUESTIONS OR COMMENTS FROM
THE COMMITTEE.>>JUST A QUICK QUESTION.
IN THE PREPARATION OF THE INITIAL REPORT, THERE WAS A LOT OF ATTENTION TO THE ROTO VACCINE,
CAN YOU COMMENT ON HOW YOU SEE THAT WORK GOING FORWARD IN RELATION WITH THIS GROUP.
>>THANK YOU IF THAT QUESTION, I THINK THE ROLE OF VACCINES IS AN ISSUE AND HOT TOPIC
AND IN NO WAY WILL IT BE DIMINISHED. I CAN’T SPEAK TO EXACTLY WHAT WILL BE IN THE
PLAN BUT WE WELCOME THE OPPORTUNITY TO COLLABORATE IN A MORE SYSTEMATIC WAY, WITH BOTH THE FACAS
AND THE ADVISORY COMMITTEES AND INTERNALLY.>>LYNN?
>>THANK YOU VERY MUCH FOR THE OVERVIEW. FOLLOWING UP ON DAVID ONE OF THE RECOMMENDATIONS
THAT WAS MADE FROM THE NVAC REPORT I THINK IT WAS DATED 2015, ON ANTIMICROBIAL RESISTANCE
WAS TO HAVE A MEMBER FROM PAC CARB SIT ON THIS COMMITTEE.
AND I THINK THAT’S SOMETHING THAT SHOULD BE CONSIDERED WITH YOUR INPUTS AND VALUES COULD
BE REALLY, REALLY CRITICAL BECAUSE VACCINES ARE GOING TO PLAY AN INCREDIBLY ROLE IN THE
INCREDIBLY GLOBAL HEALTH THREAT.>>ABSOLUTELY.
>>THAT’S SOMETHING WE HOPE TO SEE IN THE FUTURE AND ALONG THOSE LINES, I WOULD LOVE
TO SEE MORE INPUT OR COMMENTS ON THE ECONOMIC MODELS ABOUT HOW VACCINES CAN CONTRIBUTE TO
COMBATING ANTIMICROBIAL RESISTANCE BECAUSE PEOPLE WITH AMR SENSITIVE MODELS WITH VACCINE
SYSTEM SOMETHING THAT’S JUST NOT VALUED AND APPRECIATED WELL BUT WILL PLAY AN EVER INCREASING
ROLE WILL HELP VALUE WHAT WILL COME ALONG IF WE LOOK AT IT WITH THE LENS OF THE NMR.
>>I THINK THAT’S A GREAT ONE AND THAT’S ACTUALLY AND H*F-HOW THAT MIGHT HAPPEN, JUST, YOU KNOW
WELL WE’RE HAPPY TO DISCUSS IT, AND AS TO THE LADDER, IN TERMS OF ECONOMIC MODELING,
I THINK THATIA A VALID POINT AND FOR YOU AND I WILL WE WILL TALK WITH CAN ANN ABOUT HOW
WE CAN DO SOME WORK TOGETHER. THANK YOU.
>>LARRY.>>YOU PRESENTED A LOT OF DATA BUT IT’S HARD
FOR US TO COMPREHENS IT AND WITH THE CURRENT STATUS, YOU SHOULD BE HAPPY WITH HOW THINGS
ARE GOING?>>WITH THE CURRENT STATUS OF THE NATIONAL
ACTION PLAN OR RESISTANCE GENERALLY?>>IN RESISTANCE–WELL, BOTH.
MORE SO RESISTANCE IN GENERAL OR SUSCEPTIBILITY IN GENERAL, HOPEFULLY.
>>BOY THAT’S A COMPLICATED QUESTION.>>WE’RE GETTING BACK AT YOU.
>>THANK YOU.>>THANK YOU FOR THAT QUESTION.
>>I THINK THERE ARE A LOT OF ISSUES THAT WE STILL NEED TO WORK FROM.
I THINK THAT’S WHY WE DECIDED TO CONTINUE AND DO ANOTHER NATIONAL ACTION, AND WE DID
NOT THINK THAT WE WERE FINISHED. SO, I THINK WHILE OUR FRIENDS ARE IN THE U.S.,
AND BETTER, BUT WE’RE NOT GOOD ENOUGH. AND AS TO THE NATIONAL ACTION PLAN, I THINK
THE REASON WHY WE AS A TASK FORCE DECIDED TO KEEP, MAINTAIN THE FRAMEWORK OF THOSE FIVE
GOALS IS BECAUSE WE STILL SEE THERE’S A LOT OF WORK TO BE DONE IN EACH ONE OF THEM EACH
THOUGH WE COME A LONG WAY WE STILL HAVE A LOT TO GO ABOUT.
>>JUST A QUICK COMMENT THAT IN ADDITION TO THE INNOVATION AND VACCINES TO COMBAT DRUG
RESISTANCE, AND COVERAGE OF THE EXISTING VACCINES NAMELY PNEUMOCALKAL, THE GAINS WE HAVE WITH
THE DECLINE IN NONSUSCEPTIBLE PNEUMOCOCKIC AMONG POPULATION COULD BE A THREAT JUST LIKE
WHAT WE SAW WITH THE MEASLES IF THE VACCINE COVERAGE RATES ARE NOT MAINTAINED.
>>YOU’RE WELCOME. THANK YOU.
>>THANK YOU FOR THE PRESENTATION. [ APPLAUSE ]
>>BOB?>>YES?
>>IT’S KEN COOK, COULD I MAKE A COMMENT?>>PLEASE, TIM.
>>SORRY, TO BE THE–>>WE WON’T LET HER ESCAPE SO YOU CAN MAKE
A COMMENT.>>AMANDA THANK YOU VERY MUCH FOR THAT PRESENTATION,
ACTUALLY THERE HAS BEEN A PRETTY GOOD LINK BETWEEN NVACCINE AND PAC CARB, BREW ANYHOW
AN WAS ACTUALLY THE–BRUCE ANYHOW AN WAS THE RING LEADER OF PAC CARB OR WHATEVER IT WAS
AND THE GOVERNMENT LIAISON SO HE ACTUALLY HAD PEOPLE FROM THAT AND MEETING ON THE VACCINE,
AND BARRIERS AND WITHIN THE AMR TEAMS SO AND I PRESENTED AT THE END OF JANUARY TO PAC CARB
ON THE PIPELINE FOR VACCINES AGAINST THE PATHOGEN AND WHAT WAS VERY INTERESTING IN THE PIPELINE
ANALYSIS IS THERE WAS OVERALL SCENE FOR THOSE PATHOGENS ON THE THREAT LIST.
BUT IF YOU LOOKED ACROSS PHASE ONE, PHASE TWO TO PHASE THREE, WHAT YOU SAW IS THERE
WERE FOUR CANDIDATES IN PHASE ONE AND THERE WERE SOME IN PHASE THREE, AND TWO IN PHASE
THREE -FRPBLT SO NORMALLY IF YOU HAVE A ROBUST TYPE WINE, WE HAVE A LOT MORE STAGE ONE, AND
THEN THROUGH ATTRITION FEWER, YOU KNOW AS YOU GET TO PHASE THREE, BUT IN THIS CASE,
THERE WERE A LOT OF PHASE TWO PROGRAMS BUT NOT ENOUGH PHASE ONE PROGRAMS TO REALLY SUPPORT
THE PIPELINE, SO WHAT CARB EXPECTATIONS IS DOING WHAT THE NIH CONTINUES TO DO, AND THE
D.O.D. ARE PROBABLY HAVEN’T SHOWED UP YET IN THE PHASE ONE PIPELINE BUT I THINK IT WILL
BECAUSE THEY’RE DEALING WITH THE FIRST VALUE OF DEATH AS WE CALL IT WHICH IS GETTING INTO
THE CLINIC BUT ON THE FLIP SIDE, I’M VERY CONCERNED ABOUT THE SECOND VALLEY OF DEATH
WHICH IS VACCINES THAT HAVE PHASE TWO PROMISE BUT CAN’T RAISE THE HUNDRED MILLION DOLLAR
PLOT TO GET THROUGH PHASE THREE AND WHAT I RECOMMENDED TO PAC CARB IS THAT THEY CONSIDER
HAVING BARDA FUND SOME OF THESE MORE PROMISING VACCINES THAT WOULD BE GOOD FOR PUBLIC HEALTH
THROUGH PHASE THREE AND I THINK BARDA IS SET UP TO DO THAT, AND TO DO THAT SO IT’S ONE
OF MY RECOMMENDATIONS FOR PAC CARB TO CONSIDER TO TRY TO DISLODGE SOME OF THESE PHASE TWO
THAT I THINK ARE NOT FUNDED WELL ENOUGH TO GET TO PHASE THREE.
BUT JUST WANTED TO SHARE THAT AND I DID WONDER ABOUT WHETHER THEY’RE PLANNING TO UPDATE THE
THREAT LIST THAT’S A 2013 THREAT LIST AND I JUST WANTED TO ASK, IF THE CDS UP DATE THAT,.
>>SURE, SO ON THE FIRST COMMENT, YEAH, SO GOOD TO KNOW, I AM–HAVE ONLY BEEN THE TASK
FORCE FOR A COUPLE YEARS AND I DO REMEMBER THAT BRUCE GAWAN WAS THE RING LEADER FOR THE
PAC CARB INITIALLY, REALLY SORT OF HAPPY TO REVISE THAT RELATIONSHIP.
ON THE SECOND ISSUE, IN TERMS OF–I BEING THE PIPELINE GENERALLY, ECONOMIC INCENTIVES
FOR BOTH VACCINE AND WITH DRUG DEVELOPMENT, WE ARE VERY MUCH LOOKING INTO A LOT OF ISSUES
THAT YOU BROUGHT UP AND I THINK THAT’S ABOUT ALL I CAN SAY ON THAT.
AND THANK YOU FOR THE COMMENTS AND YEAH, AND THEN FOR THE LAST ISSUE, YES, I WILL JUST
GO BACK TO THE SLIDE SO CAN YOU SEE IT. ONE OF THE THINGS THAT WE ARE USING THAT LAST–ON
THE LAST BULLET AND THE THIRD DASH, 2019 UPDATE, CDC’S ANTIBIOTIC RESISTANT THREAT, UPDATING
THE THREAT REPORT, THE 2013 REPORT IS WHAT DROVE THE EXECUTIVE ORDER THAT CREATED THE
NEW NATIONAL ACTION PLAN AND THE PAC CARB, AND I THINK BEING IN THE RESEARCH COMMUNITY,
WE’VE ALL BEEN WAITING A LONG TIME FOR CDC TO UPDATE THIS REPORT AND IT WILL BECOMING
AT SOME POINT THIS YEAR, SO, THAT WILL DRIVE AS I SAID A LOT OF WHAT I THINK GOES INTO
THE NEW NATIONAL ACTION PLAN AND HOW WE PRIORITIZE OUR ACTIVITY.
GOING FORWARD. THANK YOU.
>>THANK YOU AMANDA I MISS HAVING YOUR PRESENTATION, BUT 2013 REPORT WAS REALLY USEFUL.
>>YEAH.>>AND EVERYBODY AROUND THE WORLD REFERS TO
THAT AND I THINK IT WAS A GREAT THING FOR THE CDC, IT’S THE DYNAMIC FIELD AND IT NEEDS
AN UPDATE BUT, I THINK IT WAS UTV REALLY USEFUL, I THINK WE’RE ALL WANT EAGER TO GET THAT REPORT
AND I’M EXCITED TO SEE WHAT’S IN IT BECAUSE YOU’RE RIGHT, IT DOES DRIVE POLICY AROUND
THE WORLD FOR RESISTANT BACTERIA AND GENERALLY.>>THANK YOU.
>>SO YOUR NEXT RESENTATION IS A VACCINE CABBEDIDATE AGAINST C-DIF, IT’S PRESENTED BY SAUN REDDIC
AND HE WORKS WITH THE PFIZER DEVELOPMENT GROUP WEPPING A C-DIFCANDIDATE.
HE WILL UPDATE ON US ON THE STATUS OF THIS INVESTIGATIONAL VACCINE THAT’S DESIGNED TO
HELP PROTECT AT-RISK INDIVIDUALS FROM–AM I CORRECT GEANOUS NOW, CLUSTERED M-DIFSEAL
THAT CAUSES SERIES DISEASE IN ADULTS AND COMMUNITY HOSPITAL SETTINGS.
>>THANK YOU. CERTAINLY NOT REMISS ON ME THAT THE ONLY THING
AND I WILL TRY TO BE SUCCINCT. BASED ON THE CALIBER OF QUESTIONS THAT ARE
COMING OUT AT THE STRATEGIC LEVEL FROM THIS PARTICULAR COMMITTEE, I JUST WANT TO STRESS
CLINICAL RESEARCH AND DEVELOPMENT, NOT THE BUSINESS UNIT, NOT REGULATORY AFFAIRS, SO,
I’M GOING TO BE TALKING ABOUT THE RESULTS FROM OUR TRIALS, IF YOU HAVE STRATEGIC QUESTIONS
I’M CERTAINLY AMENABLE TO HELPING YOU FIND THE RIGHT PERSON TO ANSWER THOSE AND IF YOU
WILL WRITE THIS IT DOWN, MY E-MAIL IS SHAKEN @[email protected]
I HAD THE PRIVILEGE OF WORK OTHER IN KENYA WITH HIV COUNTER MEASURES AND MALARIA, AND
AND MANY OF MY COLLEAGUES, SO I’M CERTAINLY MOTIVATED TO HELP YOU FIND THOSE ANSWERS IF
YOU HAVE STRATEGIC QUESTIONS, I DON’T THINK THIS GROUP WILL BE SURPRISED TO KNOW THAT
C-DIFREMAINS A SIGNIFICANT UNMET MEDICAL NEED, THERE ARE A LOT OF ETIOLOGIES IN TERMS OF
HOW C-DIF MANIFESTS IN THE AREA, AND THERE’S KEY COMPONENT AND THINK ABOUT THE NUMBER OF
ANTIBIOTIC REVIEWS AND PRIMARY CARE SETTINGS AND WITH THE RISK, THIS IS THOUGHT TO BE AUGMENTED
ALSO BY THE RISE IN,A CUTE CARE AMPM TYPE CLINICS AND THE SURGE IN TELEMEDICINE SO,
ANTIMICROBIAL RESISTANCE AND AND OVER 450,000 CASES PER YEAR, ALMOST 30,000 DEATHS PER YEAR
AND IF YOU HAD CDI THE RISK THAT YOU GET AGAIN IS RELATIVELY HIGH.
AND WHAT REALLY CONCERNS US IS THAT THE BULK OF THESE CASES MAY BE [INDISCERNIBLE] BUT
WE’RE CERTAINLY SEEING A RISE IN COMMUNITY CDIS SO IT DERIVED CDI, SO IT IS LEVELED URGENT
IN TERMS OF THE CDC HAZARD LEVEL AND CURRENTLY THERE’S?
THERE’S PDI AND VACCINE THAT WOULD INDUCE ACTIVE IMMUNITY.
APPROXIMATE TO ALL AGE GROUP THERE, 147 CASES A PERSON AND THAT LINE YOU SEE ACROSS AT 120
TYPICAL RECOMMENDATION AND COMMUNITY OR NATIONAL INTERVENTION AND IF YOU SLEEP APNEA AND OBESITYY
A DRAMATIC SURGE IN INCIDENTS OF CDI AND CERTAINLY SOBERING THE FACT THAT IF YOU ARE 65 OR OVER,
ONE IN 11 PATIENTS IN THIS AGE GROUP DIED OF HEALTHCARE RELATED CDI WITHIN ONE MONTH
OF DIAGNOSIS. THERE HAVE BEEN AN ENORMOUS AMOUNT OF RESOURCES
THAT HAVE BEEN UTILIZED TO ADDRESS THE HEALTHCARE ASSOCIATED CDI, FROM HIGENE TO STEWARDSHIP
PROGRAMS AND THOSE HAVE CERTAINLY HAD AN EFFECT AND WHAT WE ARE SEEING A BIT OF ALARM IS THE
COMMUNITY ASSOCIATED CDI FROM 2011 TO 2016. NOT TO GET INTO TOO MUCH OF THE NITTY-GRITTY
HERE YOU ABOUT BUT WHAT I WOULD LIKE TO DO IS THE FACT OF THIS PARTICULAR TOCKSOID, THIS
ANTIGEN THAT WE DEVELOPED, HAS THREE KEY ADVANTAGES, IT IS GENETICALLY AND SO THE IDEA IS AS IT
IS WITH MOST ANTIGENIC COUNTERMEASURES TO MODIFY THE ANTIGEN SO THAT IT DOESN’T CAUSE
DISEASE BUT NOT SO MUCH THAT IT WOULD INHIBIT AN IMMUNE RESPONSE THAT’S EFCACE, SO THIS
IS A GENETICALLY DETOXIFIED TOXIN AND EARLY STUDIES HAVE CERTAINLY APPEARED TO BE SAFETY,
I WILL GO OVER THE SAFETY DATA WITH YOU, EFFICACY HAS BEEN DEMON TRAITED IN ANIMAL MODELS AND
PRECLINICAL DATA AND WE HAVE OUR PHASE THREE THAT’S GOING WHICH WILL BASICALLY TELL US
THE BOTTOM LINE IN TERMS OF EFFICACY. AND THEN OF COURSE, HAVING AN ANTIGEN OR VACCINE
THAT CAN BE EASILY MANUFACTURED AT HIGH RATES AND QUICKLY TO ADDRESS COMMUNITY NEEDS, IT
WOULD BE IMPORTANT AND WE BELIEVE WE HAVE DONE THAT AS WELL.
I WANT TO GIVE YOU AN OVERVIEW OF OUR VACCINE CLINICAL DEVELOPMENT PROGRAM, IT’S NOT UNLIKE
MANY VACCINE PROGRAMS WHERE WE HAVE PHASE ONE IN BOTH THE U.S. AND JAPAN EARLY ON, WHICH
WHICH FEED IN AND INFORMAUR PROOF OF CONCEPT PHASE TWO, OR I’LL BE GOING OVER THAT PARTICULAR
STUDY WHICH WAS RECENTLY PUBLISHED IN CID. WE ALSO WERE PROOF OF CONCEPT OF FOR THE SUBJECTS,
AND THEN OF COURSE, I WANT TO LET YOU KNOW, WE HAVE ADDITIONAL PHASE THRESHOLD PROGRAMS,
ONE IS A LOT ONE CYSTENCY PROTOCOL AND THE TWO DOSE WHERE LOOKING AT THE IMMUNE RESPONSE
REGIMEN. WE WANT TO LOOK AT SAFETY, TOLERABILITY AND
IMMUNE O GENESISSITY, SO WHAT YOU SEE HERE IS ONE PARTICULAR COMPONENT OF THAT AMONG
SCHEDULES AND VACCINATIONS AT MONTH ZERO, IF WE HAVE DOSE REGIMENS THAT ARE VIEWED ONE
IS AT AHUNDRED MICROGRAMS AND YOU SEE A PERIOD THERE OF 12 MONTHS POST THREE.
AND AT THAT PARTICULAR TIME WE DID ANOTHER RANDOMIZATION AND GAVE A FORTH THERE’S A BOOSTER
DOSE TO LOOK AT SAFETY AND TOLERABILITY OF THIS PARTICULAR VACCINE.
THAT WILL GO ON FOR THREE YEARS. LIMP.
EMPLOY PATIENT DEMOGRAPHICS AND FEMALE TO MALE IS REASONABLE, AVERAGE AGE IS 71.3, BUT
INTERESTINGLY WE WANT TO GO EVERY THE CEREAL STATUS PRIOR TO DOSE ONE.
SO OUR COHORT HAD ABOUT 67% THAT WERE STILL NEGATIVE TO TOXIN A AND B THAT WERE 20% THAT
WERE POSITIVE PER B-ONLY TEN% OFFLY THAT WERE ZERO O TOXIC FOR TOXIN A AND THEN A SMALL
SUBSET THAT WAS BOTH A AND B POSITIVE. AND GEOMOTTIC 200 MICROGRAM DOSE VERSUS PLACEBO,
TOXIN A IS ON THE TOP AND TOXIN B IS ON THE BOTTOM CAN AND HAD IS THE MONTH SCHEDULE ZERO
ONE AND SIX AND WHAT YOU CAN SEE AFTER THE THIRD VACCINE THAT 180 DAYS THERE’S SOME RESPONSE
WHICH WENT OUT 12 MONTHS AND REMAINED WELL ABOVE BASE LINE.
TO REPORT VERY SPECIFIC COMPONENTS ORICISM TOMS THEY WERE HAVING AFTER VACCINATION, UP
TO 14 DAYS AND THIS IS A DEPICTION HERE, YOU SEE POST DOSE ONE, TWO, AND THREE.
AT THE VERY BOTTOM, YOU SEE THE VERYIABLE THAT WAS BEING REPORTED WITH THE PAIN AND
SWELLING AND PLACEBO VERSUS 200 MICROGRAM AND YOU CAN SEE THAT AFTER DOSES ONE, TWO,
AND THREE, PAIN AT THE INJECTION SITE IS HIGHER IN THE 200 MICROGRAM DOSE GROUP BUT ONLY AT
ABOUT 25% AT THE PEAKS, AND THE BULK OF THOSE WERE MILD AND MODERATE.
REDNESS AND SWELLING WAS CONSISTENT WITH PLACEBOS, WE LOOKED AT FATIGUE AND HEADACHE, AND ALSO
RELATIVELY CONSISTENT WITH OUR PLACEBOS, SO WE DIDN’T SEE A SIGNAL THERE.
FEVER WAS RELATIVELY RARE, WE DID SEE IT IN THE 200 MICROGRAM GROUP AT .05%.
SO VERY FEW INDIVIDUALS IN ALL OF THOSE WERE MILD.
DIARRHEA AND VOMITING, AGAIN, THE 200 MICROGRAM VERSUS PLACEBO AFTER EACH DOSE WERE VERY SIMILAR.
MUSCLE PAIN AND JOINT PAIN. MUSCLE PAIN IN PARTICULAR AFTER DOSE ONE AND
DOSE TWO. CERTAINLY YOU COULD SEE OR AT LEAST THINK
ABOUT THE FACT THAT IT MAY HAVE BEEN HIGHER IN THE 200 MICROGRAM GROUP FOR MUSCLE PAIN
AND JOINT PAIN. NOT SO MUCH IN THE THIRD DOSE BUT AGAIN THE
BULK OF THESE WERE GRADE ONE AND GRADE TWO. –IT LOOKS HIGHER IN THE 200 MICRO GRAM GROUP
TO PUT PERSPECTIVE ON THIS, THE TOTAL NUMBER OF SAES WERE IN THE MID20S SO LOW NUMBERS
NONE OF WHICH WERE DEEMED TO BE AND INVESTIGATIONAL PRODUCT.
THOSE INDIVIDUALS WERE THOUGHT TO BE RELATED FOR THE REGIMEN, IT WAS CONSIST WENT WHAT
WE HAD SEEN IN THE PRECLINICAL TRIALS. AND IN OUR PHASE ONES.
O BECAUSE OF WHAT WE OBSERVED IN OUR PROOF OF CONCEPT PROTOCOL, WE DECIDED TO MOVE FORWARD
WITH THE MONTH REGIMEN AND THE 200 MICROGRAM DOSE INTO A PIVOTAL PHASE THREE WHERE AGAIN
OUR GOAL WAS TO ENROLL 17,500 SUBJECTS I’M VERY POLICED TO SAY AS OF APRIL WE’VE ENROLLED
THOSE INDIVIDUALS AND THEY WERE RECRUITED BECAUSE THEY WERE CONSIDERED AT
RISK FOR CDI AND COMING INTO THE CONTACT WITH THE HEALTHCARE SYSTEM.
THIS WAS A ACCOMPLISHED OVER 382 SITES IN 23 COUNTRIES.
AGAIN, THE MONTH REGIMEN ZERO ONE AND SIX, THESE WILL BE INDIVIDUALS WILL BE FOLLOWED
UP FOR THREE YEARS, EARLY CHALLENGE IN THE DEVELOPMENT OF THIS WAS FINDING JUST THE PERSPECT
EMOJI TO REPRESENT DIARRHEA, I THINK WE PRETTY SURE WE NAILED IT.
AND I WILL TALK A LITTLE BIT ABOUT HOW THAT WORKS BUT THREE OR MORE UNFORMED STOOLS, BRISTOL
STOOL FIVE TO SEVEN WITHIN FIVE-24 HOURS, THE NEXT SLIDE WILL SHOW THAT BETTER, OUR
END TERMINAL SIS IN 63 CASES SOPHISTICATEDY IT’S IMPORTANT TO REALIZE THIS IS A THEN DRIVEN
PROTOCOL AND EVENT DRIVEN STUDY SO WHAT WE DON’T KNOW EXACTLY WHEN WE’LL BE ABLE TO FINISH
AND THEN OUR FINAL ANALYSIS IS POWERED ON 106 CASES.
SO SUBJECTS AND YOU CAN IMAGINE THE AMOUNT OF TRAINING THAT HAD TO GO INTO THIS IN THIS
PARTICULAR AGE GROUP WHERE THEY HAVE AN ELECTRONIC DEVICE THAT IS RECORDING SYMPTOMS AFTER NAVIGATION
AND THEY HAVE TO NAVIGATE ADMISSION OF A STOOL SAMPLE BUT NOT EASY TO DO BUT IF THEY HAVE
THESE THREE DIARRHEA STOOL SAMPLES THAT MEET THE CRITERIA, THE TOOL IS COLLECT INDEED THE
HOME, HOSPITAL OR CLINIC WHEREVER IT OCCURRED, SHIP IN A NANO COOLER TO OUR REGIONAL SITES
AND THEN OUR REGIONAL SITES PROCESS IN AND SEND IT TO OUR LAB IN NEW YORK.
THE DIAGNOSTIC TESTING IS A TWO STEP TESTING ALLEGOR RHYTHM WHICH WASN’T REALLY THE STANDARD
OF KACCT IRB WHEN WE INITIATED THE TRIAL, AND BECOME THE STANDARD OF CARE, BUT THIS
WAS ENDORSED BY A NUMBER OF REGULATORY AGENCIES, THE STOOL SAMPLE ITSELF WILL UNDERGO PC R
INITIALLY, AND THAT ONE WE HAD THE BACTERIA AND THEN A CCNA WILL BE AND IF THAT COMES
OUT POSITIVE THAT WILL BE A CONFIRMED CASE. SO IN CONCLUSION, CDI STILL A SIGNIFICANT
DISEASE AND UNMET NEED, WE HAVE DEVELOPED A NOVEL ANTIGEN, WITH CRITICAL EPITAUPES MAXIMIZING
THE PRODUCTION OF NEUTRALIZING AEBT BODIES, THE VACCINE INDUCES POLYCLONAL ANTIBODIES
THAT WILL NEUTRALIZE DIVERSE TOXINS, THE PROGRAM HAS PROGRESS THROUGH PROOF OF CONCEPT THE
TOTAL IS THREE, AND FULLY ENROLLED, AND IT’S A ROBUST IMMUNE RESPONSE AND STRONG SAFETY
PROFILE UP TO THIS POINT. SO OUR PHASE THREE AND ONGOING AND WE’RE AWAITING
CASE ACCRUAL. OBVIOUSLY WITH ANY STUDY THE PARTICIPANTS
ARE KEY AND WE’RE EXTREMELY GRATEFUL FOR THEM AND THE INVESTIGATORS AND THEN OUR PFIZER
CONTRIBUTORS IS AS WELL. SO I THINK THAT’S IT.
>>THANK YOU VERY MUCH. ANY COMMENTS OR QUESTIONS FROM THE COMMITTEE?
>>CODY?>>THANK YOU FOR THAT PRESENTATION, I HAVE
A COUPLE OF QUESTIONS. CERTAINLY THE DURATION OF IMMUNITY WILL BE
CRITICAL AND SO TELL BE INTERESTING TO SEE IF YOU NEED REPEAT BOOSTERS BUT THE QUESTION
I HAVE IS WHO DO YOU ANTICIPATE MARKETING THIS MARKETING THIS VACCINE FOR ANYONE WHO’S
OVER 65 OR WILL IT BE AN INDIVIDUAL WHO COMES IN CONTACT WITH THE HEALTHCARE SYSTEM AS YOU
MENTIONED AND THE WORST C-DIFIS OFTEN IMMUNE O COMPROMISED PATIENTS, PATIENTS WITH INFORMATORY
BOWEL DEFENSE, AND EXPERIENCE IN THAT POPULATION, RIGHT NOW IN TERMS OF CLINICAL TRIALS, NO,
NOT IN THAT PARTICULAR POPULATION, SOMETHING WE NEED TO LOOK AT, IN TERMS OF WHO SHOULD
GET THE VACCINE, STILL UNDER DISCUSSION, WE FEEL THAT BASICALLY EVERY AGE, CERTAINLY AT
RISK, DO YOU SEE A LARGE SHIFT AFTER 45. COMING INTO PLAY.
SO, IT’S STILL UNDER DISCUSSION.>>IS THERE AN ADJUVANT?
>>THERE’S NOT AN ADJUVANT, THIS HAS ALUM IN IT, WE DID STUDIES WITH AND WITHOUT ALUM
AND IN GENERAL IT WAS DECIDED TO LEAVE THE IT BUT IT WAS MORE AS A [INDISCERNIBLE] THAN
AN ADJUVANT.>>THANK YOU.
>>LYNN?>>I
HAVE A NUMBER OF QUESTIONS JUDGE UTV OUT OF CURIOSITY, AS FAR AS PATIENTS ARE ENROLL,
THEY WERE AT RISK FOR CDI SO PERHAPS YOU COULD EXPLAIN MORE HOW THAT’S DEFINED.
ARE YOU STRATIFIED BY CO MORBID CONDITIONS FOR EXAMPLE, ARE YOU ALSO LOOKING AT OUTCOME
MEASURES SUCH AS REDUCED ANTIBIOTIC USE, AND OTHER OUTCOMES, AND MEASURES AND LOOKEDDA
THE WHAT IMPACT IS, AND TESTED THE AUDIENCE, AND AND WITH THE BENEFIT.
>>SO, WITH REGARD TO HOW THEY’RE STRATIFIED, I WOULDN’T USE THE TERM STRATIFIED IN USE
OF PIVOTAL PHASE THREE TRIAL AND THE INDIVIDUALS WERE RECRUITED IF THEY HAD RECENT ANTIBIOTIC
USE, IF THEY HAD ONGOING MEDICAL CONDITIONS THAT WOULD SIGNAL THAT THEY WERE GOING TO
COME INTO CONTACT WITH THE HEALTHCARE SYSTEMS SUCH AS TEN PREVIOUS CLINIC VISITS, A COUPLE
HOSPITALIZATIONS MAYBE OR AN E. R. VISIT THOSE KIND OF RISK DETERMINANTS AND THAT WAS BASED
ON EPIDEMIOLOGICAL STUDIES DONE PREVIOUSLY AND IN CONJUNCTION WITH UNIVERSITIES AS WELL.
SO YOUR SECOND QUESTION?>>IT WAS AROUND THE UTILITY MEASURES.
>>IS THERE ANTIBIOTIC USE WITH THE PLACEBO VERSUS VACCINE, ACCESS TO HEALTHCARE FACILITIES
AND THE THINGS THAT CAN ADD VALUE WHEN WE LOOK AT THE OVERALL IMPACT OF THE VACCINE.
>>THERE ARE A NUMBER OF UTILITY, SECONDARY END POINTS AND EXPLORATORY END POINTS AROUND
THAT AND IT RELATES TO HOSPITALIZATION AND ASSOCIATED MORBIDITY WITH THAT.
>>ANNA?>>MY QUESTION WAS QUESTION ONE FROM LEONARD.
NANY QUESTIONS ON THE LINE.>>THANK YOU BOB.
I HAVE A COMMENT, I MEAN, I THINK THIS IS FANTASTIC TO SEE THE PRESENTATION OF THESE
REALLY BIG STUDIES THAT ARE DIFFICULT IF YOU HAVE 18,000 PATIENTS, AND SHOWS THE AMOUNT
OF THIS, AND I CERTAINLY WANT TO WISH PFIZER ALL THE LUCK WITH THIS STUDY AND OUTCOME BECAUSE
NOTHING SUCCEEDS LIKE SUCCESS. AND IT’S GREAT WHILE WE HAVE A LOT OF CHALLENGES
IN THE INDUSTRY AND IN GETTING VACCINES OUT, YOU DO HAVE BIG SUCCESS STORIES LIKE SHIN
RICKS WHICH IS FANTASTIC AND AND I HOPE A VACCINE FOR CDIFWHICH WILL ELEVATE THE AMR
VACCINES AND WE DID HAVE A BIG FAILURE FROM [INDISCERNIBLE] WHICH WAS A BIG DISAPPOINTMENT
BUT I WANT TO THANK SHAKEN FOR A PRESENTATION AND WISH THE BEST ON BEHALF OF ALL OF WHO
CARE ABOUT THE PUBLIC HEALTH.>>THANK YOU FOR THE OPPORTUNITY TO PRESENT?
>>DR. MYSELFENER HAS ONE MORE QUESTION.>>THANKS VERY MUCH, BOB.
SO DO VACCINEEES WOHAVE ADEQUATE IMMUNE RESPONSE STILL BECOME INFECTED BY C-DIFFTHAT, IS THE
ORGANISM CAN LIVE IN THEIR GI TRACT, THEY JUST DON’T MANIFEST DISEASE IN AND JUST THINKING
ABOUT COMMUNITY OR HOSPITAL SPREAD IS WHAT I WAS THINKING?
>>YEAH, IT IS A TOCKSOID ANTIGEN, RIGHT? SO THE WHYED IS THAT YOU PREVENT THE DISEASE
EVEN THOUGH IT HAS CDI, AND I THINK IT’S AN IMPORTANT POINT.
THE IMPACT THAT THAT WILL HAVE IN TERMS OF COMMUNITY VERSUS AND DETERMINE IF THOSE WERE
CERTAINLY SOME QUESTIONS THAT WERE BEING ASKED BY THE AGENCY AS WELL.
>>THANK YOU FOR THIS PRESENTATION. [ APPLAUSE ]
THIS BRINGS OUR MORNING SESSION TO A CLOSE. I HAVE BEEN ASKED TO MENTION THAT THERE IS
A FARMER’S MARKET AND POTENTIALLY AN OPTION FOR FOOD OUT AT THE TENTS FROM TRANSPLANT
OF THE BUILDING IN ADDITION TO CAFETERIA, AND I HAVE OR OTHER OPTIONS WE WILL RETHAT
FOR OUR AFTERNOON SESSION, THANK YOU.

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