>>GOOD AFTERNOON AND THANK YOU
FOR JOINING OUR WEBINAR.
I'M ANITA McRAE-WILLIAMS PLEASED
TO SERVE AS YOUR MODERATOR.
I OVERSEE OUTREACH COMMUNICATION
FOR THE EXTRA -- EXTERNAL
COMMUNITY FOR THE NCCIH AND THIS
IS TO PROVIDE YOU WITH AN
OPPORTUNITY TO HEAR MORE ABOUT
THE NOTICE FOR FUNDING
OPPORTUNITY TITLE, HEAL
INITIATIVE TOWARD DEVELOPING
QUANTITATIVE IMAGING THE OTHER
RELEVANT BIOMARKERS FOR OFFICIAL
TISSUES FOR CLINICAL PAIN
MANAGEMENT INFORMATION WEBINAR
AND THIS IS A RFA-AT-24-003
WEBINAR AND YOU'LL HAVE AN
OPPORTUNITY TO HAVE YOUR
QUESTIONS ANSWERED DURING THE
LATTER PORTION FF THE TECHNICAL
ASSISTANCE WEBINAR IS ONE HOUR
IN LENGTH AND DURING THE FIRST
HALF OF THE WEBINAR YOU'LL HEAR
PRESENTATIONS FROM NCCIH'S
DIRECTOR AND NCCIH PROGRAM AND
REVIEW STAFF.
THE LATTER HALF OF THE WEBINAR
IS ENTIRELY DEVOTED TO ANSWERING
QUESTIONS IN THE VIEWING
AUDIENCE AND YOUR QUESTIONS CAN
BE SUBMITTED USING THE VIDEOCAST
FEEDBACK FORM.
AND THAT IS BELOW YOUR SCREEN IT
IS A LIGHT GRAY ICON FOR THE
FEEDBACK FORM.
WE LOOK FORWARD TO RECEIVING
YOUR QUESTIONS.
AGAIN, YOU CAN SUBMIT THEM AT
ANY TIME.
PLEASE NOTE ATTENDANCE AT THE
TECHNICAL ASSISTANCE WEBINAR IS
OPTIONAL AND NOT A REQUIREMENT
FOR APPLICATION SUBMISSION.
THIS WEBINAR IS BEING VIDEOCAST
AND WILL BE ARCHIVED FOR LATER
VIEWING AND WILL BE AVAILABLE
FOR REBROADCAST TOMORROW ON THE
NIH EVENTS PAGE UNDER PAST
EVENTS.
NOW, IT IS MY PLEASURE TO
INTRODUCE OUR SPEAKERS FOR
TODAY'S WEBINAR.
OUR VERY FIRST SPEAKER IS IS
DR. HELENE LANGEVIN THE DIRECTOR
FOR NCCIH.
SHE BECAME THE DIRECTOR OF NCCIH
IN 2018.
FOLLOWING HER TENURE OF THE
CENTER FOR INTEGRATIVE MEDICINE
IN BOSTON JOINTLY BASED AT
BRIGHAM AND WOMEN'S HOSPITAL AND
HARVARD MEDICAL SCHOOL.
AS NCCIH DIRECTOR SHE OVERSEES
THE FEDERAL GOVERNMENT'S LEAD
AGENCY FOR RESEARCH ON THE
FUNDAMENTAL SCIENCE, USEFULNESS
AND SAFETY OF COMPLIMENTARY AND
INTEGRATIVE HEALTH APPROACHES
AND THEIR WELLNESS IN IMPROVING
HEALTH AND HEALTH CARE.
WITH THE ANNUAL BUDGET OF
APPROXIMATELY $170 MILLION,
NCCIH FUNDS AND CONDUCTS
RESEARCH TO HELP ANSWER
IMPORTANT SCIENTIFIC AND PUBLIC
HEALTH QUESTIONS WITHIN THE
CONTEXT OF WHOLE PERSON HEALTH.
FOLLOWING, DR. LANGEVIN THE NEXT
SPEAKER IS IS DR. ALEX TUTTLE IN
THE BASIC AND MECHANISTIC
RESEARCH BRANCH AT THE CENTER
FOR NCCIH WHERE HE OVERSEES THE
MANUAL THERAPY AND MANIPULATION
PORTFOLIOS AND THE PAIN AND
CLINICAL AND TRANSLATIONAL
RESEARCH PORTFOLIO.
HE HEADS SEVERAL NCCIH WIDE
INITIATIVES INCLUDING HELPING TO
END ADDICTION LONG TERM THE HEAL
INITIATIVE, MYOFASCIAL PAIN
BIOMARKERS PROGRAM IN THE JOINT
NCCIH NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND
STROKE AND RESEARCH MANIPULATION
PROGRAM.
LAST SPEAKER IS DR. SHIYONG
HUANG IN THE NCCIH'S OFFICE OF
SCIENTIFIC REVIEW AND THE REVIEW
OFFICER ASSIGNED TO THIS
OPPORTUNITY.
IN THIS CAPACITY, HE ORGANIZED
SPECIAL EMPHASIS PANELS IN
RESPONSE TO FUNDING
OPPORTUNITIES LED BY NCCIH.
SO WITH THAT, I WILL TURN IT
OVER TO OUR FIRST SPEAKER,
DR. HELENE LANGEVIN.
>>THANK YOU, VERY MUCH, ANITA
FOR STARTING US OFF.
I'M GOING START SHARING A COUPLE
OF SLIDES.
GIVE YOU SOME BACKGROUND AS TO
HOW AND WHY THIS INITIATIVE CAME
ABOUT AND WHY WE WANT TO PROVIDE
THIS OPPORTUNITY FOR REISSUING
THE INITIATIVE AND INVITING MORE
PEOPLE TO SUBMIT GRANT
APPLICATIONS.
SO THIS WHOLE PROJECT CAME ABOUT
FROM THE VERY VEXING PROBLEM IN
THAT A LARGE PROPORTION OF THE
CHRONIC MUSCULOSKELETAL PAIN
PEOPLE EXPERIENCE WHETHER PAIN
IN THE NECK, LOWER BACK IT'S
REMARKABLE WE DON'T KNOW AND WE
WANT TO ADDRESS THAT.
THIS IS A SCENARIO I'M SURE MANY
OF YOU WILL RECOGNIZE.
IT HAPPENS QUITE A LOT.
SOMEBODY WHO SPENDS A GOOD PART
OF THE WEEK IN EITHER SAEDENTAR
POSITION AND UNDER GOES A BURST
OF ACTIVITY ON THE WEEKEND AND
SUFFERS THE CONSEQUENCES
AFTERWARDS IN THE FORM OF
PAINFUL AND KNOTS AND AREAS
WHERE THE TISSUES FEEL LIKE
THEY'RE TENDER AND SORT OF HARD
TO TOUCH AND WHAT CAUSES THIS IS
QUITE AMAZING THAT WE DO NOT
UNDERSTAND THE PATHOPHYSIOLOGY
OF THESE PROBLEMS.
AND PEOPLE WHO DO VARIOUS FORMS
OF MANUAL THERAPY, FOR EXAMPLE,
PHYSICAL THERAPY AND MASSAGE,
VARIOUS FORMS OF MANUAL
THERAPIES FEEL A PRACTITIONER
AND WHEN YOU PUT YOUR HANDS ON
AN AREA OF SOMEBODY, THE AREA
WHERE IT HURTS, YOU FEEL THE
TISSUES DO NOT FEEL NORMAL TO
THE TOUCH.
THERE'S A SENSATION OF INCREASED
RESISTANCE TO PALPATION,
SOMETIMES A SENSATION THE
TISSUES ARE NOT MOVING OR
GLIDING PROPERLY BUT WE DO HAVE
GOOD WAYS TO MEASURE THIS YET AT
THE MOMENT AND WE DON'T REALLY
THE AND FOR THAT REASON THIS IS
REALLY BEEN A FACTOR THAT HAS
CAUSED THE RESEARCH ON
MYOFASCIAL PAIN AND
UNDERSTANDING THE COMPONENTS OF
THE MUSCLES AND CONNECTIVE
TISSUES THAT SURROUND THE
MUSCLES.
WE DON'T REALLY KNOW THE
CONTRIBUTION OF THESE TISSUES TO
THE PATHOPHYSIOLOGY OF
MUSCULOSKELETAL PAIN.
SO WE HAD A WONDERFUL WORKSHOP A
COUPLE YEARS AGO ON THIS AND
SOME OF THESE PROBLEMS THAT
MIGHT -- AND THESE ARE STILL AT
THE LEVEL OF HYPOTHESES THAT
MIGHT EXPLAIN BOTH THE PAIN AS
WELL AS THE TENDERNESS TO
PALPATION AND THE PALPATORY
FINDINGS PRACTITIONERS CAN
OBSERVE AND SOME HYPOTHESES ARE
RELATED TO THE MUSCLE.
FOCAL AREAS WHERE THE MUSCLE
FIBERS ARE CHRONICALLY
CONTRACTED FORMING THE TOUGH
BANDS AND THE OTHER POSSIBILITY
IS ABNORMALITIES IN THE REFLEXES
THAT CAUSES CONTRACTIONS AND IN
THE SHORTENINGS INCLUDING
POSSIBLE INFLAMMATION OR
REDUCTION IN PH, FOR EXAMPLE,
PERHAPS DUE TO CHRONIC LACTIC
ACID IN THE AREAS OF COULD BE
TRACTION.
-- CONTRACTION.
ANOTHER POSSIBILITY IS THAT
THERE'S A PROBLEM NOT IN THE
MUSCLE ITSELF BUT IN THE FASCIA
EITHER OVERLYING THE MUSCLE AND
IN BETWEEN THE SKIN AND THE
MUSCLE FOR EXAMPLE IN THE SUB
CUTANEOUS TISSUE.
THERE COULD BE INCREASED
STIFFNESS OR DENSIFICATION IN
TERMS OF HYALURONIC ACID
ACCUMULATION OR CLUMPING OR
PROBLEMS WITH WATER DISTRIBUTION
IN THE TISSUE CAUSING STIFFNESS
AND REDUCTION IN THE MOBILITY
AND IMPORTANTLY ENOUGH THERE
COULD BE A COMBINATION OF THESE
PROBLEMS AND MAY BE THEY'RE
COMPONENTS OF MUSCLE AND FASCIA
THAT CONTRIBUTE THAT MAY BE
MUTUALLY REINFORCING.
AS MENTIONED WE HAD A WORKSHOP
IN DECEMBER 2020 WE IDENTIFIED
MANY AREAS THAT WERE GAPS IN
RESEARCH.
AS A RESULT, WE ISSUED
PREVIOUSLY A REQUEST FOR
APPLICATION IB 2022 AND THIS WAS
PART OF THE HEAL INITIATIVE OR
WHICH STANDS FOR HELPING END
ADDICTION LONG TERM.
THIS IS A VERY LARGE TRANS-NIH
PROGRAM BASED ON -- AIMED AT
ADDRESSING THE OPIOID CRISIS.
AND OPIOID ADDICTION AND IN
TERMS OF INFORMATION AND BETTER
TREATING PAIN.
THE HEAL INITIATIVE FUNDED
SEVERAL APPLICATIONS IN RESPONSE
TO AND HAD A GOOD RESPONSE TO
THE FIRST REQUEST FOR
APPLICATION AND WE ENDED UP
FUNDING AN APPLICATION AND
GIVING YOU A SNAPSHOT OF THE
KINDS OF TECHNOLOGIES AND THE
PURPOSE OF THE WORKSHOP WAS TO
DEVELOP TOOLS TO INTERROGATE AND
DEVELOP QUANTITATIVE OBJECTIVE
MARKERS OF MYOFASCIAL TISSUES IN
RELATIONSHIP TO MYOFASCIAL PAIN
AND TO FIRST PHASE IS THE
DEVELOPMENT AND ALEX WILL TELL
US MORE ABOUT THAT AS TO WHAT
THE DIFFERENT PHASES ARE.
THE FIRST IS TO DEVELOP THE
TOOLS AND THE SECOND PHASE IS TO
TEST THEM IN RESPONSE TO AN
INTERVENTION THAT CAN BE USED
CLINICALLY TO TREAT MYOFASCIAL
PAIN.
THE FIRST SET OF APPLICATIONS WE
FUNDED INCLUDED ULTRASOUND, MRI,
INCLUDING ELASTOGRAPHY AND EMG
AND SPECTROSCOPY AND LOOKING AT
VARIOUS PARTS OF THE BODY, BACK,
NECK, SHOULDER, ETCETERA.
THE KINDS OF MANIPULATION PEOPLE
WILL BE USING INCLUDING
DIFFERENT TYPES OF INJECTIONS
AND DRY NEEDLING, ACUPUNCTURE
AND MANIPULATION AND DIFFERENT
TYPES OF THERAPY.
YOU CAN SEE THERE WAS A VARIETY
BUT WE FEEL BASED ON THE
RESPONSE WE GOT FOR THE FIRST
RFA THERE'S A LOT MORE OUT THERE
BEING MORE SCIENTISTS WHO COULD
COMPETE IN ANOTHER OPPORTUNITY
AND THIS IS WHAT WE'RE DOING
NOW.
SO WE REISSUED THIS REQUEST FOR
APPLICATION.
IT CAME OUT IN EARLY JUNE AND
THE DEADLINE FOR SUBMITTING
APPLICATIONS IS OCTOBER 18 --
>>AND THAT'S 2023,
DR. LANGEVIN.
>>THAT'S A TYPO.
SO 2023, THANK YOU, ALEX.
SO, YEAH, THE DEADLINE IS NOT
OVER.
SO WE WANT TO IN THIS TECHNICAL
ASSISTANCE WEBINAR TO GIVE YOU
MORE INFORMATION ABOUT THE
PROCESS OF SUBMITTING THE
APPLICATIONS, WHAT IS EXPECTED,
WHAT WOULD BE SOME OF THE
MILESTONES, ETCETERA AND ALSO
VERY IMPORTANTLY AS WAS THE CASE
FOR THE FIRST RFA, WE WANT TO
MAKE SURE PEOPLE FORM TEAMS OF
COLLABORATORS THAT WOULD INCLUDE
CLINICIANS ENGAGED IN THE
TREATMENT OF MYOFASCIAL PAIN AND
CAN GUIDE THE DESIGN OF THE
STUDIES AS WELL AS ENGINEERS,
TOOL DEVELOPERS, IMAGEERS AND
PEOPLE USED TO HANDLING COMPLEX
DATA AND SO THIS IS BASICALLY
WHAT WE ARE GOING TO BE TALKING
ABOUT FOR THE NEXT REST OF THE
WEBINAR.
>>AWESOME.
THANK YOU FOR LAYING THE STAGE,
DR. LANGEVIN.
THE NEXT SPEAKER IS DR. ALEX
TUTTLE.
>>THANK YOU, FOR SETTING THE
OVER ALL SCOPE AND IMPACT OF
BOTH THE FIRST PAY PLAN AND THE
CALL FOR THE REISSUE.
CAN EVERYONE SEE MY SCREEN?
YES?
OKAY.
I'M GETTING NODS.
THANK YOU.
I'LL FIRST GIVE A BRIEF OUTLINE
OF THE TOPICS WE'LL COVER TODAY
FOR THE REST OF THE SPEAKING
PORTION BEFORE WE GET TO YOUR
QUESTION AND ANSWER SESSION.
I'LL START WITH AN INTRODUCTION
OF THE NOFO AND THE
PARTICIPATING INSTITUTE, CENTERS
AND OFFICES TAKING PART IN THE
REISSUE.
I'LL THROUGH THE SPECIFIC
PROGRAM REQUIREMENTS, THE RFA
SCOPE AND PRIORITIES TO HELP YOU
WHAT YOU NEED TO WRITE IN YOUR
APPLICATION IN THE RESPONSE TO
THE NOTICE OF FUNDING
OPPORTUNITY OR NOFO AND THERE
WILL BE A TEAMING WEBINAR
BECAUSE THESE ARE TEAM-BASED
SCIENTIFIC PROJECTS AND WE'RE
GIVING EVERYONE AN OPPORTUNITY
TO NETWORK AND MAYBE DEVELOP
COLLABORATIONS BETWEEN THE
OCTOBER 18 DEADLINE.
WE HOPE TO SAVE ABOUT HALF AN
HOUR FOR QUESTIONS.
SUBMIT THEM THROUGH THE NIH
VIDEOCAST FEEDBACK FORM ANY TIME
DURING THE WEB DMAR.
-- WEBINAR.
THE IDEA FOR BOTH ORIGINAL ISSUE
OF THIS RFA AND REISSUE WE'RE
DISCUSSING TODAY CAME ABOUT FROM
THE 2020 HEAL WORKSHOP ON
MYOFASCIAL PAIN.
IF YOU WOULD LIKE MORE
INFORMATION ABOUT THAT WEBINAR,
THERE ARE LINKS TO THE VIDEO
RECORDINGS AND EXECUTIVE SUMMARY
AND DETAILED SUMMARIES OF THE
TWO-DAY WORKSHOP EMBEDDED IN THE
NOTICE OF THE FUNDING
OPPORTUNITY FOR REISSUE.
FIND THE LINKS AND YOU MAY FIND
COLLABORATORS AMONG THE
COLLABORATORS THAT PARTICIPATED
IN THE WORKSHOP.
THE WORKSHOP AND NOFFO -- NOFO
WAS A COLLABORATION AND WE HAVE
SEVEN OTHER I.C.s PARTICIPATING
IN THE REISSUE AND THESE ARE THE
PARTICIPATING CONTACTS.
YOU MAY HAVE HEARD ABOUT THE
OPPORTUNITY FROM AN OFFICER AND
MAYBE THIS ALIGNS WITH THE
RESEARCH YOU TYPICALLY DO BUT
ANY OF US WOULD BE HAPPY TO
ANSWER YOUR QUESTIONS AND TRY TO
RESPOND AS SOON AS POSSIBLE.
THE MYOFASCIAL UNIT IS
CONNECTIVE TISSUES AND BLOOD
VESSELS AND LYMPHATICS.
THE PARIETAL FASCIA CHANGES IN
RESPONSE TO INFLAMMATION.
THERE'S OTHER POSSIBLE
PATHOLOGICAL CHANGES THAT COULD
BE ASSOCIATED INCLUDING
FIBROSIS, FATTY INFILTRATION,
MUSCLE HYPEREXTENDABILITY OR
ISCHEMIA AND MANY HAVE BEEN
IMPLICATED IN MANY PAINFUL
CONDITIONS INCLUDING HEADACHE,
TMJ, SICKLE CELL DISEASE AND
PAIN DISORDERS IN SPECIAL PAIN
POPULATIONS.
THE KEY RESEARCH ISSUE IN THE
REISSUE THAT WE'RE PRESENTING
TODAY IS TO LEVERAGE EXISTING OR
DEVELOP NEW QUANTITATIVE AND
MINIMALLY INVASIVE TECHNOLOGIES
TO HELP US DIFFERENTIATE BETWEEN
HEALTHY AND DISEASED
MYOFASCIAL--AND THE LATENT STAGE
WHERE THERE'S NO SPONTANEOUS
PAIN BUT WE CAN OBSERVE
PATHOLOGICAL CHANGES IN THE
MYOFASCIAL UNIT WHEN PRESSED AND
THE ACTIVE STAGE WHERE A PERSON
EXPERIENCES SEVERE PAIN
SPONTANEOUSLY WITH OBSERVABLE
PATHOLOGICAL CHANGES IN THE
MYOFASCIAL UNIT.
AS DISCUSSED IN THE HEAL
WORKSHOP IN 2020, THERE ARE MANY
CUTTING EDGE TECHNOLOGIES
AVAILABLE THAT COULD BE USED TO
DEVELOP QUANTITATIVE MEASURES TO
DIFFERENTIATE DISEASE FROM
HEALTHY TISSUE STATES AND THEY
CAN SERVE AS CANDIDATE
INDICATORS OR BIOMARKERS IN A
FUTURE GRANT OR PROJECT THAT CAN
HELP DIFFERENTIATE DISEASE FROM
HEALTHY MYOFASCIAL UNITS.
SOME EXAMPLES OF THE
TECHNOLOGIES DISCUSSED AT THE
2020 WORKSHOP WERE MR
ELASTOGRAPHY AND TISSUE
PROFUSION, LASER DOPPLER IMAGING
OR MODELLING AND SIMULATIONS.
AND IT'S IMPORTANT TO NOTE THAT
AS DR. LANGEVIN SHOWED A MINUTE
AGO, MANY APPLICATIONS THAT
FUNDED WERE USING
MULTIPARAMETRIC MODALITIES TO
ARRIVE AT COMPOSITE OR PARALLEL
QUANTITATIVE MEASURES OF THE
MYOFASCIAL UNIT.
SO WE DO WANT TO IMPRESS UPON
YOU YOU ARE WELCOME TO LEVERAGE
MORE THAN ONE OF THESE
TECHNOLOGIES MAYBE CONCURRENTLY
TO STUDY THE MYOFASCIAL UNIT.
I WANTED TO PULL OUT SPECIFIC
APPROACHES WE'RE STRESSING FOR
THE REISSUE.
THESE ARE OF PARTICULAR INTEREST
US TO THIS TIME AROUND.
IT'S IMPORTANT TO MENTION NO
PRELIMINARY DATA ARE REQUIRED
AND I'LL GET TO THE R61 VERSUS
THE R33 PHASE IN A MOMENT AND
FEASIBILITY MAY BE DEMONSTRATED
THROUGH LITERATURE CITATIONS OR
DATA YOU MAY HAVE GENERATED IN
ANIMAL STUDIES OR HUMAN SUBJECT
STUDIES YOU PREVIOUSLY
CONDUCTED.
YOU MAY CHOOSE ONE TYPE OF
TECHNOLOGY OR MULTIPLE
TECHNOLOGIES DESCRIBED ABOVE TO
DEVELOP THE QUANTITATIVE
MEASURES TO ASSESS THE
MYOFASCIAL UNIT AND MUSCLE AND
CONNECTIVE TISSUE AND LYMPHATICS
AND IT SHOULD BE DESCRIBED TO
DISTINGUISH HEALTHY VERSUS
DISEASED TISSUE STATES WITH A
REASONABLE DEGREE OF FIDELITY.
SO NOW GETTING TO THE MEAT OF
THE TWO-PHASED AWARD OF THE RFA.
IT REQUIRES TWO PHASES OR TWO
TYPES OF STUDIES.
IN THE FIRST PHASE THE R61
PHASE, THE CANDIDATE SHOULD
PROPOSE OBSERVATIONAL STUDIES TO
HELP DEVELOP ANY OF THE
TECHNOLOGIES DESCRIBED IN THE
PREVIOUS SLIDE OR LISTED ON THIS
SLIDE IF YOU SEE ANY OF THESE
TECHNOLOGIES SUMMARIZED IN THE
RFA TO ASSESS IN HUMAN SUBJECTS
AND SEE IF IT CAN DIFFERENTIATE
AMONG DISEASED AND HEALTHY
MYOFASCIAL UNITS AND PLAY SELECT
A POPULATION WITH A CERTAIN TYPE
OF PAIN SUCH AS POPULATIONS WHO
EXPERIENCE HEADACHE, TEMPORAL
MANDIBULAR DISORDER, NECK, ARM,
LEG OR PELVIC PAIN OR A
JUSTIFIABLE PAIN CONDITION IN
CERTAIN POPULATIONS DENOTED IN
THE SPECIFIC RFA.
I WANT TO EMPHASIZE YOU MUST
INCLUDE A BRIEF PLAN IN THE R61
PHASE HOW TO EXTEND YOUR
INVESTIGATOR TEAM WITH
ADDITIONAL EXPERTISE AND
INTERVENTIONS IF YOUR RFA IS NOT
ABLE TO IDENTIFY SPECIFIC
COLLABORATORS DURING YOUR
COLLABORATION PREPARATION
PROCESS.
WE'RE NOT ASKING FOR IT TO BE
FULLY DEVELOPED BUT NEED TO
SPECIFY A PLAN BY WHICH YOU'LL
BUILD A CLINICAL TEAM TO PERTURB
THE MEASURES YOU'RE STUDYING TO
LOOK FOR CHANGES IN THE
MYOFASCIAL UNIT AND MUST ALSO
INDICATE YOU'LL COMPLETE THE
CLINICAL STUDY PROTOCOL AS PART
OF THE DESCRIPTION.
IN THE APPLICATION, SPECIFIC
AIMS PAGE AS WELL AS YOUR
RESEARCH STRATEGY SECTION, TWO
SEPARATE SECTIONS YOU'LL BE
WRITING, YOU'LL NEED TO INCLUDE
THE R61 TO R33 CRITERIA.
INCLUDE QUANTITATIVE MILESTONES
TO SPECIFY THE THRESHOLDS YOU'LL
USI
USING.
IF MULTIPLE THRESHOLDS ARE
PROPOSED PRIORITIZATION SHOULD
BE PROVIDED TO DETERMINE WHICH
MEASURES WOULD BE MOVED FORWARD
TO THE R33 PHASE FOR BIOMARKER
DEVELOPMENT.
IF YOU'RE DOING MULTIPLE
MEASURES YOU NEED TO PRIORITIZE
WHICH ONES DO YOU EXPECT TO GO
TO THE R33 PHASE.
ALTERNATIVELY, IF THE THRESHOLD
OF THE COMPOSITE MEASURE IF YOU
DECIDE TO USE A COMPOSITE
MEASURE OR THRESHOLD OF THE
MEASURE AMONG MULTIPLE
TECHNOLOGIES YOU MUST PROPOSED
THE R33 PHASE IF ARE DOING
MULTIDIMENSIONAL IN THE R61
PHASE AND MILESTONES MUST
INCLUDE THRESHOLDS AND PREFERRED
METRICS ARE EFFECT SIZES SUCH AS
GREATER THAN .5 AND AVERAGE AREA
UNDER THE CURVE FOR EXAMPLE FOR
ROC OF . OR OTHER METRICS OF
CLASSIFICATION ACCURACY SUCH AS
SENSITIVITY AND SPECIFICITY
METRICS IF YOU'RE TARGETING A.I.
TARGETED FOR 70% ACCURACY.
INCLUDE THE TIME LINE -- SORRY.
IF YOU'RE REQUESTING THE TWO OR
THREE-YEAR R61 PHASE YOU CAN
CHOOSE, FINISH BY MONTH 32.
IF THE FULL THREE R61 PHASE YOU
NEED TO HAVE YOUR EXPERIMENTS
DONE BY MONTH 32 AFTER THE AWARD
TO REQUEST A TRANSITION TO THE
NEXT PHASE.
WE NEED A RUN OF THREE OR FOUR
MONTHS TO RECEIVE ALL THE
MATERIALS FOR TRANSITION TO THE
R33 AND REVIEW THOSE INTERNALLY.
BEFORE I GET TO THE R33 PHASE,
THERE ARE MANY EXISTING
TREATMENTS USED TO STUDY
MYOFASCIAL PAIN AND FEW
INTERVENTIONS OR TREATMENTS HAVE
SUFFICIENT ACCURACY OR
MECHANISTIC EVIDENCE.
PART OF THE GOAL OF THIS NOTICE
OF FUNDING OPPORTUNITY IS TO USE
AND FURTHER DEVELOP THE
INTERVENTIONS TO PERTURB THE
MYOFASCIAL UNIT TO SEE HOW THE
INTERVENTIONS CAN CHANGE THE
GROUND STATE YOU'RE DEVELOPING
IN YOUR QUANTITATIVE MEASURE OR
THRESHOLD IN THE INITIAL R61
PHASE.
SO FOR THE R33 PHASE YOU MUST
CHOOSE ONE OR MORE OF THE
FOLLOWING TREATMENTS AND
THERAPIES AND THE APPROPRIATE
CONTROL GROUP TO DESIGN THE
RANDOMIZED CONTROL TRIAL.
IT MAY BE A MANIPULATION
INCLUDING MANUAL THERAPIES OR
STRETCHING-BASED THERAPIES, DRY
NEEDLING OR ACUPUNCTURE,
TARGETED INJECTION THERAPIES
SUCH AS LIDOCAINE AND OTHER
MANIPULATIONS.
IF YOU CHOOSE OTHER ANOTHER NOT
LISTED IN THE FIVE BULLET POINTS
THE APPLICATION SHOULD DESCRIBE
EVIDENCE SUPPORTING DEVELOPMENT
OF THAT INTERVENTION'S AFFECT ON
THE MYOFASCIAL UNIT AND HOW THE
CHOSEN THERAPY WILL PRODUCE
CHANGES TO BE MEASURED USING THE
QUANTITATIVE ASSESSMENT IN THE
R31 PHASE.
YOU ALSO NEED TO TEST THE YOU
NEED TO TEST OR PERFORM AN
APPROPRIATE CLINICAL PAIN
ASSESSMENT AT BASELINE AND AT
THE END OF THE INTERVENTION
ASSESS THE QUANTITATIVE MEASURE
TO PREDICT OUTCOMES OF THE
INTERVENTION.
WE NEED CLINICAL VERIFICATION OF
THE MYOFASCIAL UNITS INVOLVED IN
WHAT YOU'RE MEASURING.
THIRDLY, YOU SHOULD PROPOSE TO
PERFORM A CLINICAL PAIN
ASSESSMENT -- SORRY.
I'M MISSING A BULLET POINT.
AND YOU SHOULD PROPOSE TO
PERFORM AN ASSESSMENT OR
CALCULATE THE SENSITIVITY AND
SPECIFICITY OF THE R61 AND
MONITOR THE TREATMENT RESPONSE
AND PREDICT CLINICAL OUTCOMES.
A PLAN SHOULD BE INCLUDED IN THE
R33.
DESPITE THE MANY REQUIREMENTS OF
THE PHASE WE WANT TO STRESS TO
APPLICANTS YOU SHOULD BE BRIEF
IN DESCRIBING THIS PORTION OF
THE PROPOSAL AS THE R33 DESIGN
MAY BE MODIFIED AT THE TIME OF
TRANSITION.
WHEN YOU REQUEST A TRANSITION
FROM THE R61 TO R33 YOU'LL HAVE
TIME TO NEGOTIATE OR PROVIDE A
MORE COMPLETE PICTURE OF YOUR
R33 STUDY.
ALSO REMEMBER TO COMPLETE THE
HUMAN SUBJECTS IN CLINICAL TRIAL
INFORMATION FORM FOR YOUR
INITIAL APPLICATION.
BOTH THE R33, R61 AND TRANSITION
ARE ALL EVALUATED DURING REVIEW.
GOOD HUANG WILL GO IN MORE
DETAIL ABOUT THAT.
FOLLOWING HEAL DATA RESOURCE
SHARING POLICY.
I ENCOURAGE YOU TO REVIEW THE
LINKS AS YOU PREPARE SINCE IT'S
NEEDED IN YOUR APPLICATION.
THE LINKS ARE ALSO IN THE NOTICE
OF FUNDING OPPORTUNITY.
PLEASE REMEMBER THAT THE SCOPE
OF THIS RFA PRECLUDES ANIMAL
MODEL STUDIES AND THE
APPLICATION MUST INCLUDE
QUANTITATIVE S OF AT LEAST ONE
COMPONENT OF THE MYOFASCIAL UNIT
IN THE DEVELOPMENT OF
QUANTITATIVE THRESHOLDS AND
MEASURES AND THE R33 PHASE OF
THE SYSTEM AND USE MINIMALLY OR
NON-INVASIVE TECHNOLOGIES
OTHERWISE THE APPLICATION IS
DEEMED NON RESPONSIVE AND AN
APPLICATION THAT FAILS TO HAVE
THE PHASE DESCRIPTION OR DOES
NOT INCLUDE AN R33 SECTION AT
ALL WOULD BE DEEMED NOT
RESPONSIVE TO THIS NOTICE OF
FUNDING OPPORTUNITY.
BEFORE I HAND THINGS OVER TO
DR. HUANG.
THIS IS TO STIMULATE THE
ADAPTATION OF INNOVATIVE IMAGING
TECHNOLOGIES AND SIMILAR
QUANTITATIVE ASSESSMENT METHODS
TO DETERMINE HEALTHY OR DISEASED
MYOFASCIAL UNITS IN SUBJECTS.
STRONG APPLICATIONS NEED A WELL
CONCEIVED PLAN AND R61 PHASE
THAT LASTS UP TO THREE YEARS AND
QUANTITATIVE ASSESSMENT METHODS.
THE DESCRIPTION OF THE RFA PHASE
SHOULD BE BRIEF AND DESCRIBE THE
INTERVENTIONS IN THE CLINICAL
PAIN POPULATION YOU'LL BE
STUDIES TO TEST THE QUANTITATIVE
THRESHOLDS DEVELOPED IN THE R61.
WE'RE SOFTENING THE BIOMARKER
TERM AND IT COULD BE A BIOMARKER
IN THE FOLLOW-UP STUDY.
THE RESEARCH PLAN MAY BE
MODIFIED BASED ON THE CAUGHT
COMES OF THE STUDY AND APPROVAL
BY THE HEAL PROGRAM TEAM AS WE
EVALUATE THE APPLICATION.
ONCE AGAIN, HIGHLY INVASIVE
TECHNOLOGIES AND BIOMARKERS WILL
BE DEPRIORITIZED FOR THE NOFO.
AND I'LL PASS IT TO MS.
WILLIAMS.
>>THE LAST SPEAKER IS
DR. SHIYONG HUANG WITH THE
OFFICE OF SCIENTIFIC REVIEW.
YOU'LL HEAR THE REVIEW
PRIORITIES AND OTHER INFORMATION
IN THE REVIEW PROCESS.
TAKE IT AWAY.
>>THANK YOU.
WE'LL NOW GO THROUGH THE
PERSPECTIVE.
I'LL ADDRESS THIS ASPECT OF THE
REVIEW OF THE APPLICATIONS.
IF AN APPLICATION IS NON
RESPONSIVE, NON COMPLIANT OR
INCOMPLETE IT WILL NOT BE
ACCEPTED.
WE WOULD LIKE TO TALK ABOUT THE
COMPLETENESS OF THIS NOFO.
AND WE WILL HAVE INFORMATION
INCLUDED IN THE TIME LINES AT
END OF MY PRESENTATION.
IN RESPONSIVENESS.
THE DECISION WILL BE MADE BY
PROGRAM STAFF.
THERE'S ALREADY DETAILS OF
RESPONSIVE AND NON
RESPONSIVENESS PAY ATTENTION TO
ALL STATEMENTS LIKE MUST, MEET
AND REQUIRED IN THE NOFO.
FOR THE APPLICATION TO BE
COMPLIANT THE MAXIMUM BUDGET IS
$500,000 IN GRAD COSTS AND FOR
THE R33 IS $700,000 A YEAR
DEPENDING ON THE PHASE.
THE MAXIMUM IS A COMBINED IS
FIVE YEARS UP TO THREE YEARS FOR
THE R61 PHASE AND COMPONENTS
LIKE FOREIGN COLLABORATORS ARE
ALLOWED BUT FOREIGN INSTITUTIONS
ARE NOT ELIGIBLE TO APPLY.
FOR THE SPECIFIC AIMS CANNOT
EXCEED ONE PAGE.
THE RESEARCH STRATEGY CANNOT
HAVE MORE THAN 12 PAGES.
THE PAGE LIMITS ARE FOR BOTH
PHASES COMBINED.
APPENDIX, HAVE YOUR INSTRUCTIONS
TO THE SF424 AND IF YOU INCLUDE
THE APPENDIX AND IT'S NOT
ALLOWED ACCORDING TO THE POLICY
OR SPECIFICALLY LISTED BY THE
NOFO YOU RISK THE SUBMISSION TO
BE DROPPED.
THE NOFO ALLOWS POST-SUBMISSION
MATERIALS SUCH AS PAPER ACCEPTED
FOR PUBLICATION AND THEY'RE
LISTED HERE.
REMEMBER THAT.
THE SUBMISSION MATERIALS SHOULD
BE SUBMITTED AT LEAST 30 DAYS
PRIOR TO THE PEER REVIEW
MEETING.
AT THE END OF THE PUBLIC HEALTH
INFORMATION OF COVID-19 THE
FLEXIBILITY NO LONGER APPLY.
PRELIMINARY DATA ARE NOT
ALLOWED.
THE GOVERNMENT HAS TO HAVE THIS
ATTACHED AND THE TRANSITION
CRITERIA REQUIRED TO BE
SUBMITTED AND DATA MANAGEMENT
AND SHARING PLAN.
SO THE DATA MANAGEMENT AND
SHARING PLANS AND THE IDEA IS
THEY'RE ONLY ASSESSED WITH COSTS
ASSOCIATED WITH IMPLEMENTING AS
A PLAN AND THE REQUIREMENT FOR
SUBMISSIONS YOU NEED IN THE
INTRODUCTION TO SUMMARIZE
SPECIAL CHANGES AND ADDITIONS
AND DIMENSIONS TO THE
APPLICATION AND RESPONDING TO
THE PRIOR REVIEW.
HERE IS AN OVERVIEW OF THE
REVIEW CRITERIA.
THERE'S AN APPROACH AS WELL AS
ADDITIONAL CRITERIA FOR THE OVER
ALL IMPACT SCORE.
AND ADDITIONAL REVIEW CRITERIA
SPECIFIC FOR THIS NOFO.
PLEASE MAKE SURE YOU HAVE THIS
IN YOUR APPLICATION.
THERE WOULD BE TWO PHASES.
ONE AND TWO AND THREE AND
REVIEWERS PROVIDE ONLY PROPOSED
PHASES.
ADDITIONAL LANGUAGE HAS BEEN
ADDED TO THE STANDARD CRITERIA
AND REVIEWERS WILL BE ASKED TO
ADDRESS THE STANDARD AND NOFO
SPECIFIC LANGUAGE.
FOR EXAMPLE, FOR SIGNIFICANCE
YOU CAN SEE THE NOVO SPECIFIC
CRITERIA ON THIS SLIDE.
SO PLEASE MAKE SURE YOU TAKE
INTO CONSIDERATION OF THE REVIEW
CRITERIA IN PREPARING YOUR
APPLICATION.
IN ADDITION, REVIEWERS WILL BE
ASKED TO ADDRESS AND MATCH WHAT
APPLICANTS NEED TO ADDRESS IN
THE APPLICATION.
HERE IS AN EXAMPLE.
THERE'S A RESEARCH STRATEGY OF
THE NOFO.
APPLICANTS ARE ASKED TO IMPLY
ONE OR MORE OF TECHNOLOGIES TO
DIFFERENTIATE HEALTHY FROM
DISEASED MYOFASCIAL UNITS IN THE
CLINICAL PAIN CONDITION AND
THEY'LL APPROACH A QUANTITATIVE
TECHNOLOGY JUSTIFIED FOR THE
QUANTITATIVE MEASURES TO
DIFFERENTIATE THE DISEASED OR
HEALTHY STATE OF THE MYOFASCIAL
UNITS.
AND MILESTONES ARE ONE
ADDITIONAL CRITERIA.
THIS REVIEW CRITERIA IN THE
APPLICATION.
PLEASE MAKE SURE YOUR
APPLICATION HAS THESE PARTS.
AN APPLICATIONS WILL BE REVIEWED
BY THE SPECIAL EMPHASIS PANEL
AND SELECTED IN THE EXPERTISE IN
THE NOFO AND ASSIGNED IN
PROPOSED APPLICATIONS.
REVIEWERS WILL BE ORIENTED TO
USE ADDITIONAL CRITERIA SUCH
ADDS MILESTONES AND PLEASE KEEP
IN MIND TO ADDRESS HOW YOUR
APPLICATION WOULD BE IMPACTFUL
CONSIDERING THE GOALS OF THE
NOFO.
HERE ARE KEY DATES.
THE DUE DATE FOR THE END IS
SEPTEMBER 1.
LETTER OF INTENT IS DESIRED BUT
NOT REQUIRED.
WE ENCOURAGE YOU TO SUBMIT A
LETTER OF INTENT TO PREPARE FOR
THE REVIEW OF THE APPLICATIONS.
PLEASE SEND YOUR LETTER OF
INTENT TO DR. JESSICA McKLVEEN
AND USE THIS FOR THE SUBMISSION
AND RESUBMISSION UP TO OCTOBER
18.
PLEASE MAKE SURE YOU SUBMIT YOUR
APPLICATION BEFORE THE DUE DATE.
REVIEW MEETING AROUND JANUARY
2024.
IN SUMMARY, PLEASE MAKE SURE
YOUR APPLICATION IS RESPONSIVE
TO THE NOFO, HAS ALL COMPONENTS
REQUIRED AND DOES NOT HAVE
DOCUMENTS NOT ALLOWED AND
FINALLY PLEASE SUBMIT YOUR
APPLICATION BEFORE THE DEADLINE.
THANK YOU AND LET US KNOW IF YOU
HAVE ANY QUESTIONS.
>>AWESOME.
THANK YOU TO MY PRESENTERS AND
NOW THE LONG AWAITED Q&A TIME.
I SEE WE HAVE A FEW QUESTIONS
ALREADY.
I DO WANT TO CLARIFY SOMETHING
FOR THE PEOPLE THAT HAVE ENTERED
THIS VIDEO CAST THROUGH ZOOM,
YOUR SCREEN HAS A Q&A FEATURE AT
THE BOTTOM OF THE SCREEN SO YOU
CAN SUBMIT YOUR QUESTIONS
THROUGH THAT Q&A FEATURE AND IF
YOU ENTERED THROUGH YOUR
VIDEOCAST WE HAVE A FEEDBACK
FORUM SO YOU CAN SUBMIT THEM
THAT WAY THROUGH THE VIDEOCAST.
WE'RE READY TO ANSWER YOUR
QUESTIONS.
LET'S GET STARTED.
FIRST QUESTION, IS THERE A
SPECIFIC PROCESS FOR
RESUBMITTING A PROPOSAL TO THE
HEAL SOLICITATION FROM LAST
YEAR, FOR EXAMPLE, SHOULD ONE
USE AN ADDITIONAL PAGE TO
RESPOND TO THE RELEVANT --
EXCUSE ME TO THE REVIEWERS
COMMENTS FROM THE PREVIOUS
SUBMISSION SO THAT WAS LAST
YEAR.
ALEX?
>>DR. HUANG ADDRESSED THIS
DURING HIS SLIDE SO WOULD YOU
LIKE TO ANSWER THIS QUESTION?
>>YEAH, SO YOU SUBMIT YOUR
APPLICATION AS A RESUBMISSION
YOU NEED TO CHECK THE TYPE OF
APPLICATION AS RESUBMISSION AND
ALSO THE INTRODUCTION THAT
SUMMARIZES THE ADDITION OR
CHANGE OF YOUR APPLICATION OR
RESPONSE TO THE PRIOR YEAR.
>>THANK YOU.
THE NEXT QUESTION IS MY FIRST
SUBMISSION, WHICH WAS LAST YEAR,
FOCUSSED ON LOW BACK.
CAN I STILL FOCUS ON LOW BACK IN
THE RESUBMISSION?
>>YES, THANK YOU.
AS WE NOTED, THE PAIN
POPULATIONS RESPONSIVE WERE
DESCRIBED IN THE FIRST.
I THINK WE JUST PRIORITIZED
SPECIFIC POPULATIONS WE'RE
HOPING CAN EXPAND THE OVER ALL
PAIN PLAN BUT BOTH THE OMT AS A
THERAPY STILL RESPONSIVE TO THE
R33 PHASE AS A MANIPULATION.
SO WE DON'T SEE ANY PROBLEM WITH
OMT BEING RESPONSIVE TO THE R33.
>>THANK YOU, DR. TUTTLE.
THE NEXT QUESTION IS OSTEOPATHIC
MANIPULATIVE TREATMENT PRACTICED
FROM D.O. PHYSICIANS CONSIDERED
IN THE MANIPULATIVE THERAPY
PROCEDURE.
>>I COMBINED THESE TWO
QUESTIONS TOGETHER WHEN I WAS
READING THEM.
IT'S MY FAULT.
LOW BACK PAIN IS STILLIVE AS A
PAIN TYPE AND O.M.T. IS STILL
RESPONSIVE AS A POTENTIAL
THERAPY.
IT BLED INTO THE O.M.T. BUT
SHOULD BE THE CASE.
>>THE NEXT QUESTION IS IS THE
NUMBER OF PATIENTS IN THE
PROPOSAL IMPORTANT?
FOR EXAMPLE, 25 PATIENTS WOULD
THAT SUFFICE IN A GOOD SIGN --
WELL DESIGNED PROPOSAL?
>>SO YOUR APPLICATION DOES NOT
NEED TO BE POWERED TO DETERMINE
EFFICACY.
THAT'S NOT THE PRIMARY PURPOSE
OF THE R33 OR NOFO IN GENERAL,
HOWEVER, WE DO WANT YOU TO
DESCRIBE IN YOUR SPECIFIC
MILESTONES A QUANTITATIVE
THRESHOLD OR A SIGNIFICANT
DIFFERENCE BETWEEN HEALTHY AND
DISEASED TISSUE STATES.
YOU'LL NEED TO COME UP WITH
EXPERIMENTS AND POWER
CALCULATIONS SUFFICIENT TO
DEMONSTRATE A MODERATE AFFECT
SIZE, FOR EXAMPLE, AS LISTED IN
THE NOFO.
I CAN'T SAY SPECIFICALLY WHAT
YOU'RE CLINICAL POPULATION
SHOULD BE HOWEVER, YOU NEED TO
KEEP IN MIND YOU'LL BE ASSESSED
BY REVIEW ON THE MILESTONES YOU
INCLUDE.
YOU NEED TO KEEP THE POWER
CALCULATIONS IN MIND.
>>NEXT QUESTION, BESIDES
IMAGING TECHNOLOGIES MENTIONED
IN THE WEBINAR, CAN NOVEL
MEASURES ALSO BE USED BY
INVASIVE MEASURES SUCH AS BLOOD
SAMPLING AND TISSUE CODES.
ARE THOSE ALLOWABLE?
>>SO WE ARE NOT ALLOWING HIGHLY
INVASIVE THRESHOLDS OR
QUANTITATIVE MEASURES OR
ASSESSMENTS.
BASED ON WHAT THIS QUESTION IS
ALLUDING TO, I DON'T BELIEVE
THAT WOULD BE DEEMED TO BE
RESPONSIVE.
WE'RE INSTEAD LOOKING FOR
MINIMALLY INVASIVE OR
NON-INVASIVE ASSESSMENTS TO
MEASURE QUANTITATIVE THRESHOLDS.
>>NEXT QUESTION, CAN BLOOD WORK
AND ENERGY HEALING APPLY TO THIS
NOFO?
>>SO, I'M ASSUMING THIS PERSON
IS TALKING SPECIFICALLY ABOUT
THE INTERVENTION THAT THEY WOULD
EMPLOY DURING THE R33 PHASE.
WE ARE ALLOWING ADDITIONAL
THERAPEUTIC TYPES TO BE
PROPOSED.
HOWEVER, YOU NEED TO HAVE A
STRONGLY -- A STRONG REASONING
AND RATIONALE FOR HOW YOU
BELIEVE YOUR CHOSEN INTERVENTION
WOULD LEAD TO A DEMONSTRABLE OR
MEASURABLE DIFFERENCE BETWEEN
TISSUE AT BASELINE AND AFTER THE
INTERVENTION.
THE IDEA IS THAT THE
INTERVENTION IS TO PERTURB THE
MYOFASCIAL UNIT, LOOK AT CHANGES
IN THE MYOFASCIAL UNIT BEFORE
AND AFTER THE INTERVENTION BASED
ON THE THRESHOLD YOU'VE
DEVELOPED IN YOUR R61 PHASE.
UNLIKE THE FIRST ISSUE WHERE WE
WERE RELEGATED TO CERTAIN TYPES
HOWEVER, REVIEW WILL BE
EVALUATING WHETHER THERE IS A
STRONG RATIONALE FOR THE
INTERVENTION TO SEE A DIFFERENCE
IN THE MYOFASCIAL UNIT.
YOU HAVE TO BRING THE
JUSTIFICATION TO THE
APPLICATION.
>>THE NEXT QUESTION -- AND
THANK YOU FOR THE GREAT
QUESTIONS, KEEP THEM COMING.
ARE DATA-DRIVEN A.I./M.L. MODELS
ACCEPTABLE FOR DISCOVERY OF S OR
IS THE EMPHASIS ON
HYPOTHESIS-DRIVEN APPROACH
GENERALLY THE CASE AT NIH?
>>WELL, I DON'T NECESSARILY
WANT TO SPEAK TO OTHER FUNDING
OPPORTUNITIES AVAILABLE FOR A.I.
OR MACHINE LEARNING RESEARCH AND
WHETHER THE OTHER RFAs ARE
HYPOTHESIS DRIVEN OR NOT.
IN THE CASE OF THIS NOFO WE DO
SUPPORT A.I. OR MACHINE LEARNING
COMPOSITE MEASURES BEING USED TO
LOOK AT COMPOSITES OR MULTIPLE
PERI METRIC OR MULTI-MODAL
IMAGING OR MINIMALLY INVASIVE
TECHNIQUES.
AGAIN, THERE WAS THE BIOMARKER
IN THE ONE SLIDE HOWEVER, WE ARE
NOT REQUIRING YOU DEVELOP A
BIOMARKER AT THIS STAGE FOR THIS
NOVO IT'S TO DEVELOP
QUANTITATIVE MEASURES OR
THRESHOLDS THAT COULD BECOME A
BIOMARKER THROUGH MORE RESEARCH
BUT THIS IS MORE UPSTREAM OF
THAT.
IF YOU ARE GOING TO PROPOSE A
A.I./M.L. IT SHOULD BE WHAT WAS
MENTIONED IN THE REVIEW OR
APPLICATION.
>>AND TO DRAW ATTENTION TO
FREQUE
FREQUENTLY ASKED QUESTIONS ON
THE NCCIH WEBSITE.
SOME QUESTIONS YOU'RE ANSWERING
ARE SIMILAR TO THE FREQUENTLY
ASKED QUESTIONS RECEIVED PRIOR
TO THE WEBINAR.
I THINK YOU'LL FIND THOSE
HELPFUL.
I'LL ASK A REVIEW QUESTION.
SO SHIYONG, WITH TWO PHASES, THE
R61 AND R33, HOW WILL MY
APPLICATION BE SCORED?
AUTO
>>THANK YOU FOR THIS QUESTION.
WE'LL PROVIDE ONE SO THE R61 AND
R33 PHASE.
THEY'RE COMBINED FOR BOTH
PHASES.
>>GREAT, LET ME FOLLOW-UP WITH
THIS QUESTION, WILL MILESTONES
INFLUENCE THE SCORE?
>>YES, SO MILESTONES IS AN
ADDITIONAL CRITERION AND IN
ALLOWING THE CRITERIA TO PRODUCE
AN IMPACT SCORE AND HOW IT'S
BALANCED DEPENDS ON THE
REVIEWER'S JUDGMENT.
>>ALL RIGHT.
THE NEXT QUESTION, IS THERE A
LETTER OF INTENT THAT CAN BE
USED AS A GUIDE FOR FIRST-TIME
APPLICANTS TO VIEW TO KNOW IF
THEY ARE PROVIDING YOU THE
CORRECT INFORMATION AND FORMAT
FOR THE FIRST SUBMISSION?
>>YEAH, SO, I CAN ANSWER THE
QUESTION.
A LETTER OF INTENT IS NOT
REQUIRED OR BINDING AND IT
ALLOWS US, STAFF, TO PLAN THE
REVIEW.
BASICALLY WE WANT TO KNOW IF
YOU'RE GOING SUBMIT THE
APPLICATION AND WHAT KIND OF
PERSONNEL WILL BE THERE AND WHAT
RESEARCH WE ARE GOING TO HAVE
PROPOSED.
THAT'S THE BASIC INFORMATION WE
WANT TO KNOW.
AND YOU CAN SUBMIT YOUR FORM
APPLICATION AND CAN BE CHANGED
BECAUSE THE LETTER OF INTENT IS
NOT PART OF THE APPLICATION.
>>ALEX, IS THERE ANYTHING YOU
WANT TO SAY?
I SAW YOU TYPING.
>>SORRY, I'M NOT MUTED SO YOU
PROBABLY HEARD THE TYPING.
I RESPONDED WITH A LINK TO THE
NIAID FOR WHAT THE BEST
PRACTICES ARE FOR LETTER OF
INTENT, ETCETERA.
THIS MAY HELP THE POTENTIAL
APPLICANT WRITE A LETTER OF
INTENT.
JUST SOME BEST PRACTICES THERE.
>>THAT'S GOOD INFORMATION.
OKAY.
NEXT QUESTION, ARE FASCIA
TISSUES INCLUDING METAGENES
BEING CONSIDERED IN THE RFA?
>>AS WE MENTIONED, COMPONENTS
OF THE MYOFASCIAL UNIT ARE
WITHIN THE SCOPE OF THIS RFA.
A RATIONALE JUSTIFICATION FOR
MYOFASCIAL TISSUE AND TO ASSESS
IN THE PHASE WILL BE REQUIRED
AND IT'S UP TO THE APPLICANT TO
SUBMIT AND THEY CAN FOLLOW UP IF
THEY HAVE ADDITIONAL QUESTIONS.
>>WHAT IS THE BEST PERSON OR
E-MAIL TO ASK ANY ADDITIONAL
QUESTIONS INCLUDING PROPOSED
THERAPIES?
I CAN FOLLOW UP WITH YOU ON THAT
AT THE END OF THE WEBINAR, I'LL
LIST THAT INFORMATION AND POINT
OF CONTACT AN REVIEW AND
PROGRAM.
>>AS I MENTIONED WE HAVE
PROGRAM CONTACTS SO IF THERE'S
SOMEBODY YOU PREFER TO REACH OUT
YOU CAN LOOK AT THE LIST OF
NAMES OR ME AND I BELIEVE WE
HAVE A HEAL SHARED INBOX.
YOU CAN'T GO WRONG WRITING TO
THAT IN BOX BECAUSE WE'RE ALL ON
IT.
>>PROBABLY YOU ALL WERE INVITED
TO THIS WEBINAR FROM AN
INVITATION FROM US COMING FROM
THAT MAILBOX SO PLEASE USE THAT
TO RESPOND.
OKAY.
WHAT IS THE DURATION AND BUDGET
FOR THE R61 AND R33 PHASES.
ALEX, WOULD YOU LIKE TO ANSWER
THAT.
I THINK SHIYONG IS AVAILABLE.
>>WE EXPECT TO MAKE UP TO FIVE
AWARDS THIS TIME AND FOR THE
SPECIFIC PHASES I THINK
DR. HUANG GO OVER THIS BUT DO
YOU WANT TO REITERATE, SHIYONG?
>>YEAH, SO FOR THE BUDGET LI
LIMIT -- I'M TRYING TO FIND THE
INFORMATION FOR THE R61 IS
$500,000 IN DIRECT COSTS PER
YEAR AND R33 IS $700,000
DEPENDING ON THE PHASE.
>>WE STRONGLY DISCOURAGE
APPLICATIONS FOR A ONE YEAR
DEVELOPMENT BECAUSE WE'RE
EXPECTING YOU TO COME UP WITH
NOVEL QUANTITATIVE MEASURES OR
THRESHOLDS LEVERAGING NEW OR
EXISTING TECHNOLOGIES THAT CAN
BE LEVERAGED IN THIS NEW AREA.
WE EXPECT THE TECHNOLOGY PORTION
SO WE STRESS A TWO-YEAR PHASE OF
$500,000 PER YEAR AND THE DIRECT
COSTS DEPENDS ON A TWO-YEAR OR
THREE-YEAR R61 PHASE SO COLLECT
THE NUMBERS FOR THE SPECIFIC
NOFO AGAIN.
>>ARE BOTH QUANTITATIVE AND
QUALITATIVE MEASURES ACCEPTABLE?
IF YES OR NO, A SIGNIFICANT
MEASURE?
>>SO WE EXPECT THIS TO BE
QUANTITATIVE MEASURES.
A QUALITATIVE MEASURE I DON'T
THINK WOULD BE RESPONSIVE TO
THIS NOFO.
HOWEVER, I WILL SAY THAT IF YOU
HAVE ANY QUESTIONS IT'S BETTER
TO REACH OUT TO YOUR PROGRAM
OFFICERS EARLIER RATHER THAN
SUBMITTING YOUR 12-PAGE PLUS ALL
YOUR 398 AND ALL THE OTHER
PAPERWORK IF YOU'RE NOT SURE
WHAT'S RESPONSIVE.
IT'S BETTER TO CONTACT US EARLY
SO PLEASE CONTACT US IF YOU HAVE
QUESTIONS.
>>CAN I SUBMIT MY APPLICATION
LATE?
>>I CAN FIELD THIS QUESTION.
NO, YOU CANNOT SUBMIT YOUR
APPLICATION LATE.
THE NOFO HAS LATE SUBMISSION IS
NOT ALLOWED.
PLEASE SUBMIT AS EARLY AS AS
POSSIBLE.
>>YOU HEARD IT HERE, BE LATE,
BE LEFT OUT.
CAN YOU CLARIFY THE DIFFERENCE
IN ELIGIBILITY BETWEEN FOREIGN
COMPONENTS AND
NON-U.S. INSTITUTIONS?
>>YES.
COMPONENTS ALLOW AS PART OF THE
SUBMISSION.
AND THE FOREIGN INSTITUTION OR
FOREIGN COMPONENT OF THE
INSTITUTIONS IS NOT ELIGIBLE TO
BE SUBMITTED.
>>GRET.
-- GREAT.
LET ME JUST CHECK HERE.
I HAVE ONE LAST QUESTION.
IS THE MYOFASCIAL UNIT AND UPPER
EXTREMITY PAIN IN STRESS
DISORDER RELEVANT TO THIS NOFO?
>>WE HAVE A QUESTION FROM THE
FAQ.
LET ME GO BACK TO WHAT WE WROTE.
SO THIS WAS AN EXAMPLE THAT WE
GAVE IN THE FAQ SAYING THAT IF
AN APPLICANT WOULD LIKE TO MAKE
A CASE THAT WE'RE GOING TO
STRESS DISORDER IS RELEVANT TO
THE NOFO.
YOU NEED TO EXPLAIN THE
RELEVANCE OF THE MYOFASCIAL UNIT
AND CHANGES TO THE MYOFASCIAL
UNIT WILL BE STUDYING IN ANY
PROPOSED PAIN CONDITION IN THE
APPLICATION.
IT DOESN'T HAVE TO BE THE
PRESCRIBED TYPE OF PAIN THAT WE
ARE CALLING FOR IN THIS RFA.
HOWEVER, YOU NEED TO PROVIDE
STRONG RATIONALE FOR WHY
MYOFASCIAL UNIT IS IMPLICATED IN
THE KIND OF PAIN YOUR PROPOSED
TO STUDY.
>>OKAY.
I'M JUST CHECKING MY QUESTION
BOX.
THERE'S QUESTIONS PENDING AND
I'D LIKE TO INVITE DR. LANGEVIN
OR ANY OF MY OTHER TWO SPEAKERS
TO GIVE ANY OTHER PARTING
REMARKS BEFORE I CLOSE DOWN THE
WEBINAR.
>>I CAN SAY A FEW WORDS.
SO AS DR. TUTTLE EXPLAINED VERY
NICELY, OUR FOCUS IN THE REISSUE
IS TO ALLOW, FIRST OF ALL PEOPLE
WHO HAD ALREADY SUBMITTED
APPLICATIONS THAT DID NOT GET
FUNDED BUT THAT RECEIVED
FEEDBACK FROM THE REVIEW AND AN
OPPORTUNITY TO RESUBMIT.
THE AREAS OF PREVIOUS AREAS OF
FOCUS ARE STILL VALID.
HOWEVER, WHAT WE NOTICED IN THE
APPLICATION S THAT WE FUNDED
BEFORE IS THERE WERE AREAS WHERE
WE DID NOT HAVE ACTUALLY DID NOT
RECEIVE APPLICATIONS THAT WERE
FUNDABLE OR RECEIVE APPLICATIONS
AT ALL IN THE AREAS.
THOSE ARE THE SPECIFIC AREAS
THAT DR. TUTTLE HIGHLIGHTED IN
HIS AREAS OF SPECIAL INTEREST IN
THIS REISSUE BUT THEY'RE NOT
MEANT TO BE EXCLUSIVE.
THAT'S IMPORTANT.
AND SAME THING WITH THE KINDS OF
THERAPIES THAT ARE CONSIDERED
RESPONSIVE VERSUS NON-RESPONSIVE
AND A LOT OF THOSE QUESTIONS
WERE ANSWERED VERY NICELY BUT IF
YOU HAVE ANY FURTHER QUESTIONS,
CONTACT THE PROGRAM STAFF AND
HOPEFULLY THERE ARE LOTS OF YOU
OUT THERE THAT WILL BE INSPIRED
TO SEND US APPLICATIONS AND WE
LOOK FORWARD TO RECEIVING THEM.
>>ALEX OR SHIYONG?
ARE YOU GOOD?
>>ANY CLOSING COMMENTS?
>>YOU CAN IF YOU WANT TO.
I'M JUST INVITING YOU IF YOU
WANT TO.
>>I WANT TO SAY MAKE SURE YOU
ARE HAVE ALL THE COMPONENTS IN
THE APPLICATION AND MAKE SURE
IT'S RESPONSIVE AND COMPLETE AND
SUBMITTED.
>>I WOULD SAY PROBABLY THE MOST
IMPORTANT THING IS BECAUSE YOU
STILL HAVE TIME AS YOU WRITE THE
APPLICATION REACH OUT TO PROGRAM
STAFF IF YOU HAVE QUESTIONS.
IT'S BETTER TO GET FEEDBACK
RATHER THAN WAITING UNTIL AFTER
SUBMISSION AND FINDING OUT YOU
DID NOT WRITE A RESPONSIVE
APPLICATION.
I WANT TO REITERATE AGAIN THIS
IS A MASSIVE EFFORT SO I HAVE
MANY TO THANK FOR CO-LEADING THE
INITIATIVE AND REISSUE AND THE
SEVEN OTHER I.C.s WHO HELPED
REISSUE THE RFA AND HELP AS THE
SUBMISSIONS COME IN.
THANK YOU FOR THE TEAM AND FOR
DR. LANGEVIN FOR GIVING THE
SCOPE AND HISTORY OF THE FIRST
ISSUE AND THANK YOU, ANITA, FOR
ORGANIZING THE TECHNICAL
ASSISTANCE WEBINAR AND
MODERATING TODAY.
>>IT'S MY PLEASURE.
I WANT TO THANK ONE MORE TIME
OUR PRESENTERS, DR. LANGEVIN AND
DR. TUTTLE AND DR. HUANG.
THANK YOU SO MUCH FOR YOUR WELL
PREPARED PRESENTATIONS.
I THINK THEY'LL HAVE A BIG
IMPACT AND AGAIN THANK YOU TO
OUR VIEWING AUDIENCE.
YOU'RE VERY IMPORTANT TO US AND
YOUR QUESTIONS WERE RIGHT ON PAR
WE THANK YOU FOR JOINING THE
WEBINAR AND THE EVENT IS BEING
VIDEOCAST AND WILL BE ARCHIVED
FOR LATER VIEWING SO TOMORROW
AROUND THIS TIME YOU SHOULD BE
ABLE TO RETRIEVE IT FROM THE NIH
EVENTS SITE UNDER PREVIOUS
WEBINARS.
ALSO, YOU WILL RECEIVE AN E-MAIL
FROM ME LATER TODAY WITH A
SURVEY REQUESTING YOUR FEEDBACK.
IT TAKES ABOUT TWO MINUTES TO
COMPLETE AND YOUR FEEDBACK IS
VERY IMPORTANT TO US AS WE
CONTINUE TO SHAPE FUTURE
WEBINARS MUCH INTEREST TO YOU.
LET ME GO TO THE NEXT SLIDE.
>>LET ME BRING IT UP.
>>I SAW ALL THE HAND GESTURES.
>>I WASN'T SURE WHETHER I WAS
DRIVING THIS OR NOT.
>>WHILE WE'RE WAITING, WHAT I'M
DOING IS PROMOTING THE SECOND
PART OF THIS WEBINAR SERIES
WHICH WILL BE ON AUGUST 16 FROM
11:00 TO 12:15, A DIFFERENT
TIME, SAME DAY BUT WE HOPE
YOU'LL TAKE PART IN THIS
NETWORKING WEBINAR DESIGN TO
FACILITATE CONVERSATIONS WITH
PROGRAM OFFICIALS AND TOPIC
EXPERTS RELATED TO THE TECHNICAL
REQUIREMENTS OF THE R33 PHASE OF
THE FUNDING OPPORTUNITY.
SO WE HOPE YOU CAN JOIN US NEXT
WEEK.
I THINK IT WOULD BE BENEFICIAL
TO YOU.
PLEASE FOLLOW-UP WITH DR. ALEX
TUTTLE, THE NCCIH DIRECTOR IF
YOU HAVE QUESTIONS RELATED TO
NCCIH OR WANT TO DISCUSS YOUR
PROJECT AIMS IN MORE DETAIL.
FOR REVIEW QUESTIONS FOLLOW-UP
WITH THE DIRECTOR OF THE NCCIH
OFFICE OF SCIENTIFIC REVIEW AND
WHO IS A REVIEW CONTACT ON THE
NOFO.
AGAIN, THANK YOU FOR YOUR
PARTICIPATION IN THIS WEBINAR
TODAY.
WE HOPE IT WAS CONSISTENT AND
CLARIFIED YOUR KEY
CONSIDERATIONS AND QUESTIONS
DURING THE APPLICATION AND
REVIEW PROCESS.
SEE YOU NEXT WEEK FOR PART TWO.
ENJOY THE REMAINDER OF YOUR DAY.