COHEN VETERANS BIOSCIENCE INC
1 BROADWAY 14TH FLOOR, CAMBRIDGE, MA 02142 www.cohenveteransbioscience.org

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Organizations Filed Purposes: COHEN VETERANS BIOSCIENCE IS DEDICATED TO FAST-TRACKING THE DEVELOPMENT OF DIAGNOSTIC TESTS AND PERSONALIZED THERAPEUTICS FOR THE MILLIONS OF VETERANS AND CIVILIANS WHO SUFFER THE DEVASTATING EFFECTS OF TRAUMA-RELATED AND OTHER BRAIN DISORDERS.

FAST-TRACKING PRECISION DIAGNOSTICS AND PERSONALIZED THERAPEUTICS FOR ADVANCING BRAIN HEALTH

A SHIFT FROM A SYNDROMIC CLASSIFICATION SYSTEM TO A MECHANISTIC ONE NECESSITATES A REVIEW OF THE CURRENT SCIENTIFIC KNOWLEDGE, ADOPTION OF NEW SCIENTIFIC MODELS, AND IDENTIFICATION OF RESEARCH AND KNOWLEDGE GAPS. THE SOSS BROUGHT TOGETHER MULTIDISCIPLINARY STAKEHOLDERS WITH DEEP SCIENTIFIC AND CLINICAL EXPERTISE TO ADDRESS THIS PRESSING NEED.THE THEME OF THE SECOND STATE OF THE SCIENCE SUMMIT, HELD IN 2019 WAS PATHS TO TREATMENT FOR TRAUMATIC BRAIN INJURY(S) WITH A FOCUS ON THE TAXONOMY AND NOSOLOGY OF THE CHRONIC SEQUELAE, CHALLENGES AND OPPORTUNITIES IN CLINICAL PRACTICE AND DEVELOPMENT, AND ETIOLOGY AND MECHANISM OF PERSISTENT SYMPTOMS. AS MEASUREMENT TOOLS ADVANCE, RESEARCH HAS BEEN ABLE TO FOCUS ON DIFFERENT TYPES OF INJURY, BEYOND THE MILD, MODERATE, AND SEVERE CLASSIFICATIONS OF TBI. TO AUGMENT AND SUPPORT THE MANY EFFORTS ACROSS FIELDS AND ORGANIZATIONS OVER THE PAST DECADE, IN 2020 WE WORKED WITH THOUGHT LEADERS ACROSS TBI TO PREPARE A CONSENSUS BLUEPRINT TO DRIVE TRANSLATIONAL SCIENCE FOR TBI, WHICH WE EXPECT TO PUBLISH IN EARLY 2021.CVB CONTINUES TO DEVELOP INNOVATIVE WAYS TO CONVENE AND ENGAGE THOUGHT LEADERS DESPITE THE LIMITATIONS ON LARGE IN-PERSON EVENTS DUE TO COVID-19. OUR EDUCATION AND ADVOCACY WORK HAS CONTINUED ON A FULLY REMOTE BASIS RESULTING IN THE ADVANCEMENT OF IMPORTANT RESEARCH AREAS, AND PLANS ARE BEING MADE FOR AN EVENT IN SUMMER 2021. ADAPTIVE PLATFORM TRIALS:CVB IS SPEARHEADING THE DESIGN AND APPLICATION OF "SMART- OR "ADAPTIVE-" CLINICAL TRIALS FOR NEUROPSYCHIATRIC AND NEURODEGENERATIVE CONDITIONS. THESE STUDIES INCLUDE A PROSPECTIVELY PLANNED OPPORTUNITY FOR MODIFICATION OF ONE OR MORE SPECIFIED ASPECTS OF THE STUDY DESIGN BASED ON DATA (USUALLY INTERIM DATA) COLLECTED FROM SUBJECTS IN THE STUDY. TO EXECUTE SUCH PROGRAMS, OUR CENTRALLY-MANAGED PLATFORM CLINICAL TRIAL INFRASTRUCTURE (BRAIN-NET) WILL BE LEVERAGED TO CONDUCT STUDIES ACROSS BRAIN CONDITIONS AND POPULATIONS INCLUDING ACADEMIC, PRIVATE, VA, AND POTENTIALLY MILITARY RESEARCH CENTERS.CURRENTLY, ONLY TWO DRUGS ARE APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION FOR THE TREATMENT OF PTSD, ALTHOUGH BOTH ARE ONLY MODESTLY EFFECTIVE IN TREATING MILITARY-RELATED PTSD. OVER THE PAST 18 YEARS, INDIVIDUAL ACADEMIC INVESTIGATORS AND COMPANIES HAVE NOT DELIVERED ALTERNATIVE FDA-APPROVED DRUGS. IN RESPONSE TO THIS UNMET NEED, OUR PROGRAM IS DESIGNED TO TEST MULTIPLE DRUGS TO ADVANCE THEM THROUGH REGULATORY APPROVAL. IN THE FUTURE, WE ENVISION EXPANDING OUR EFFORTS TO OTHER THERAPEUTIC SOLUTIONS (E.G. DEVICES, ALTERNATIVE THERAPIES), THROUGH OUR EVIDENCE-DRIVEN CLINICAL TRIAL NETWORK INFRASTRUCTURE.BEST BIOMARKER PTSD STUDY:DESPITE THE EFFICACY OF PSYCHOTHERAPY AS FIRST-LINE TREATMENT FOR PTSD, LARGE INTER-INDIVIDUAL DIFFERENCES IN OUTCOMES EXIST, WITH ROUGHLY 50% OF PATIENTS RESPONDING TO TREATMENT AND FEWER THAN THAT FULLY REMITTING. THIS GRANT SUPPORTED THE DEVELOPMENT OF A RESPONSE DIAGNOSTIC TEST BASED ON PRELIMINARY FINDINGS FOR A COMBINATION COGNITIVE/IMAGING MARKER RESULTING FROM CVB'S INVESTMENT IN THE COHEN VETERANS CENTER STUDY AT NYU/STANFORD. THE PROGRAM INCLUDED A CLINICAL STUDY AT TWO CENTERS OF OVER 200 SUBJECTS TO REPLICATE THE INITIAL FINDING, AND IS SEEKING QUALIFICATION VIA THE FOOD AND DRUG ADMINISTRATION ("FDA") GUIDANCE TO SUPPORT THE COMMERCIALIZATION AND/OR AVAILABILITY OF THE TEST FOR CLINICAL PRACTICE AND RESEARCH AND DEVELOPMENT. THIS STUDY COMPLETED RECRUITMENT IN DECEMBER 2019 AND SEMINAL RESULTS WHICH DEMONSTRATE THAT AN EEG BASED BIOMARKER CAN PREDICT TREATMENT RESPONSE FOR INDIVIDUALS WITH PTSD OR MDD WERE PUBLISHED IN 2020.PTSD GENETICS PROGRAM:THE PSYCHIATRIC GENETICS CONSORTIUM-PTSD WORKING GROUP - BROAD INSTITUTE COLLABORATION IS SUPPORTING THE LARGEST GLOBAL GENOME WIDE ASSOCIATION STUDY ("GWAS") OF PTSD TO DATE WITH DATA FROM OVER 200,000 INDIVIDUALS ANALYZED. THE MAIN GOAL IS TO UNCOVER THE GENETIC UNDERPINNINGS OF PTSD RISK AND PUBLISH ALL RESULTS. SEMINAL FINDINGS OF THE FIRST PTSD GENETIC RISK LOCI FROM THIS PROGRAM WERE PUBLISHED IN NATURE COMMUNICATIONS IN OCTOBER 2019.IN 2020, MULTIPLE SECONDARY ANALYSES OF THIS SEMINAL DATABASED HAVE BEEN PUBLISHED:NEUROPSYCHOPHARMACOLOGY - 1/11/20 - POLYGENIC PREDICTION AND GWAS OF DEPRESSION, PTSD, AND SUICIDAL IDEATION/SELF-HARM IN A PERUVIAN COHORT.TRANSLATIONAL PSYCHIATRY - 1/20/20 - GENOMIC INFLUENCES ON SELF-REPORTED CHILDHOOD MALTREATMENT.NEUROPSYCHOPHARMACOLOGY - 3/16/20 - DISSECTING THE GENETIC ASSOCIATION OF C-REACTIVE PROTEIN WITH PTSD, TRAUMATIC EVENTS, AND SOCIAL SUPPORTCELL REPORTS - 6/2/60 - ANALYSIS OF GENETICALLY REGULATED GENE EXPRESSION IDENTIFIES A PREFRONTAL PTSD GENE, SNRNP35, SPECIFIC TO MILITARY COHORTS.SLEEP - 4/15/20 - MOLECULAR GENETIC OVERLAP BETWEEN POSTTRAUMATIC STRESS DISORDER AND SLEEP PHENOTYPESIN 2020, WE CONTINUED OUR PROGRAM WITH THE BROAD INSTITUTE TO CONDUCT FUNCTIONAL GENOMICS STUDIES OF IDENTIFIED GENETIC MARKERS AS WELL AS GENETIC EXPRESSION ANALYSIS OF AMYGDALA CELLULAR CIRCUITS IN ORDER TO INITIATE THE IDENTIFICATION OF POTENTIAL TARGETS FOR THERAPEUTIC INTERVENTION IN PTSD.NATIONAL NEUROIMAGING NORMATIVE LIBRARY PROGRAM:CVB HAS CREATED AN IMAGING REFERENCE LIBRARY ESSENTIAL TO THE DEVELOPMENT OF EFFECTIVE CLINICAL IMAGING TOOLS FOR DIAGNOSING AND MANAGING PATIENTS WITH BRAIN DISORDERS. ADVANCED NEUROIMAGING CAN NOW DETECT MICROSCOPIC CHANGES IN BRAIN STRUCTURE CAUSED BY TRAUMA OR DISEASE. THESE ADVANCED IMAGING APPROACHES INCLUDE DIFFUSION TENSOR IMAGING (DTI), FUNCTIONAL CONNECTIVITY, PERFUSION WEIGHTED IMAGING, AND VOLUMETRIC IMAGING. DESPITE THEIR PROMISE, THESE ADVANCED APPROACHES ARE CURRENTLY PRIMARILY CONFINED TO RESEARCH USE. THE NUMERICAL NATURE OF THE INFORMATION THESE ADVANCED IMAGING APPROACHES YIELD IS DIFFICULT TO TRANSLATE FROM THE STUDY OF GROUPS OF INDIVIDUALS TO A SINGLE PATIENT WITHOUT A REFERENCE. THE IMAGING DATABASE IS BASED ON THE RESULTS OF A NATIONAL STUDY OF NORMATIVE INDIVIDUALS, SPONSORED BY CVB AT UNIVERSITY OF VIRGINIA, BAYLOR UNIVERSITY AND UNIVERSITY OF UTAH AND TWO MILITARY SITES. STANDARDIZED ADVANCED NEUROIMAGING SCANS ON 3,000 ADULT VOLUNTEERS, THE RESULTING IMAGING DATA, ALONG WITH DEMOGRAPHIC INFORMATION AND THE RESULTS OF NEUROCOGNITIVE ASSESSMENTS, IS FORMING A LIBRARY DOCUMENTING POPULATION VARIATION IN BRAIN STRUCTURE AND FUNCTION AS MEASURED BY THESE ADVANCED IMAGING METHODS.THROUGH THIS IMAGING DATABASE, IT IS OUR GOAL TO ADVANCE NEUROIMAGING TO DRAMATICALLY IMPROVE THE IDENTIFICATION OF AFFECTED INDIVIDUALS AND ALLOW PHYSICIANS TO OBJECTIVELY AND EFFICIENTLY DIAGNOSE CONDITIONS SUCH AS TBI, DEMENTIA AND OTHER BRAIN DISORDERS WHERE BRAIN STRUCTURE IS DETECTED VIA MRI.PTSD AND TBI PRECLINICAL MODELING PROGRAM:ANIMAL MODELS OF PSYCHIATRIC DISORDERS OFFER A COMPLEMENTARY RESEARCH MODALITY THAT SUPPORTS CLINICAL RESEARCH. IN ORDER TO ACHIEVE A SATISFACTORY DEGREE OF VALIDITY AND RELIABILITY, ANIMAL MODELS OF COMPLEX AND INTRICATE PSYCHIATRIC DISORDERS, SUCH AS PTSD, MUST FULFILL CERTAIN CRITERIA: PATHOGENIC PROCESSES MUST BE OBSERVABLE AND MEASURABLE, AND MUST RELIABLY REFLECT CLINICAL SYMPTOMATOLOGY, AND PHARMACOLOGICAL AGENTS THAT ARE KNOWN TO AFFECT SYMPTOMS IN HUMAN SUBJECTS, SHOULD MODULATE THESE PROCESSES. CVB HAS ESTABLISHED THE ALLIANCE FOR MODELS OF PTSD, INNOVATIVE TECHNOLOGIES AND UNIFORM PRACTICES ("AMP-IT- UP") TO SUPPORT PRECLINICAL MODEL DEVELOPMENT. MULTIPLE SUB-GRANT AWARDS COMPLETED AND PUBLISHED THEIR FINDING THIS YEAR IN SUPPORT THE MISSION OF THIS PROGRAM. IN ONE OF THESE, NEW MOLECULAR PATHWAYS HAVE BEEN IDENTIFIED THAT UNDERLIE FEAR-CONDITIONING, A KEY COMPONENT OF TRAUMA-RESPONSE:NATURE COMMUNICATIONS - 10/14/20 - GENOME-WIDE TRANSLATIONAL PROFILING OF AMYGDALA CRH-EXPRESSING NEURONS REVEALS ROLE FOR CREB IN FEAR EXTINCTION LEARNING.COMPUTATIONAL MODELING & DATA SCIENCES:CVB HAS ESTABLISHED AN INTRAMURAL DATA SCIENCES PROGRAM TO BUILD MACHINE-LEARNING AND ARTIFICIAL INTELLIGENCE BASED PREDICTIVE MODELS OF DISEASE. THESE PROGRAMS BUILD ON OUR ORIGINAL ORION MS BIO-MODELLING PROGRAM AND FOCUSES ON MODELS OF PTSD, TBI, PARKINSONS AND DEMENTIA AND OTHER CONDITIONS.MULTIPLE SCLEROSIS (MS) 1.0:THE ORION BIONETWORKS FLAGSHIP PROGRAM SUCCESSFULLY PILOTED THE ESTABLISHMENT OF A MULTIPLE SCLEROSIS ("MS") BIONETWORK COMPRISED OF ACADEMIC (NEUROSCIENCE INSTITUTE OF THE BRIGHAM AND WOMEN'S HOSPITAL), ADVOCACY (ACCELERATED CURE PROJECT FOR MS), COMPUTATIONAL (GNS HEALTHCARE, METACELL, THOMSON REUTERS), INFORMATICS (CONVERGE BY DELOITTE, RANCHO BIOSCIENCES, EXAPTIVE), AND ONLINE PATIENT COMMUNITY PARTNERS (PATIENTSLIKEME [PLM]). DE-IDENTIFIED HIPPA-COMPLIANT DATA FROM THREE DATABASES WERE CURATED AND LOADED INTO A CLOUD-BASED DATA KNOWLEDGE MANAGEMENT SYSTEM. THE INTEGRATED REPOSITORY INCLUDES 9,000 SUBJECTS WITH MS AND RELATED CONDITIONS. THE ALLIANCE DEVELOPED A ROADMAP FOR JOINT EXECUTION WITH SPECIFIC SCIENTIFIC AIMS.

THE ALLIANCE HAS GENERATED MULTIPLE MODELS BASED ON THE DATA REPOSITORY USING DIFFERENT ALGORITHMIC APPROACHES: PHENOTYPIC PROGNOSTIC MODEL AND TWO MOLECULAR PROGNOSTIC MODELS.PARKINSON'S PROGRESSION MARKERS INITIATIVE (PPMI) DATA SCIENCE MODELING GROUPEXISTING DIAGNOSES FOR COMPLEX BRAIN DISORDERS SUCH AS PARKINSON'S DISEASE (PD) FOCUS ON UNDERSTANDING CLUSTERS OF MAJOR SYMPTOMS. IN ORDER TO DRIVE PROGRESS IN THE DEVELOPMENT OF NEW TREATMENTS IT IS IMPORTANT TO UNDERSTAND THE ROLE OF SPECIFIC BIOLOGICAL PROCESSES IN DETERMINING PATIENT OUTCOMES. IN THIS PROGRAM WE MODEL THE MICHAEL J. FOX FOUNDATION (MJFF) SPONSORED PARKINSON'S PROGRESSION MODEL INITIATIVE (PPMI) STUDY. THE STUDY HAS EVALUATED PARTICIPANTS' CLINICAL STATUS WHILE COLLECTING IMAGING, BEHAVIORAL, 'OMICS AND OTHER ASSESSMENTS LONGITUDINALLY SINCE 2010. IN OUR ALIGNED MISSIONS TO ADVANCE BRAIN HEALTH, MJFF SELECTED CVB'S DATA SCIENCE TEAM TO LEVERAGE THIS COHORT TOGETHER WITH A MULTI-DISCIPLINARY APPROACH TO QUANTITATIVELY EXPLORE, EVALUATE, AND PREDICT DISEASE TRAJECTORY, RISK FACTORS, AND SUBTYPES. GIVEN THE BREADTH AND DEPTH OF THE PPMI DATA AND RICH OPPORTUNITIES TO DEVELOP IMPACTFUL DISEASE MODELS, THE TEAM USE THEIR SUBJECT MATTER EXPERTISE ACROSS TRANSLATIONAL SCIENCE TO GENERATE INSIGHTS FROM 'OMICS, IMAGING, GENETIC AND CLINICAL DATA BY INTEGRATING TECHNIQUES ACROSS ADVANCED STATISTICS, MACHINE LEARNING, AND COMPUTATIONAL MODELING TO FACILITATE PD BIOMARKER DISCOVERY AND DEEPEN OUR UNDERSTANDING OF DISEASE PROGRESSION. IN 2020, WE COMPLETED THE FIRST ANALYSES OF THESE DATA THAT WILL BE PUBLISHED SOON.PTSD & TBI KNOWLEDGEMAP (TRADEMARKED):THE BRAINTRAUMA KNOWLEDGEMAP PROJECT IS USING INFORMATION TECHNOLOGY AND VISUALIZATION TO BUILD AN INNOVATIVE NEW INTERACTIVE TOOL TO EXTRACT INFORMATION FROM PUBLISHED PAPERS FOR THE RESEARCH COMMUNITY. THE WORK INCLUDES EXTRACTION OF PTSD BIOMARKER AND TBI LITERATURE. THIS PROJECT IS PART OF OUR 'KNOWLEDGE ENGINEERING' PROGRAMMING EFFORTS TO MOVE FROM 'BIG DATA' TO 'SMART DATA'.GLOBAL PRECLINICAL DATA FORUM (TRADEMARKED):THE GLOBAL PRECLINICAL DATA FORUM (GPDF) IS A JOINTLY SPONSORED U.S. AND EUROPEAN INITIATIVE THAT ENCOURAGES GLOBAL COLLABORATION TO ADDRESS THE CHALLENGE OF ENSURING THAT PRECLINICAL RESEARCH IS REPRODUCIBLE, ROBUST AND TRANSLATABLE TO SUPPORT DISEASE RESEARCH UTILITY FOR CLINICAL RESEARCH & DEVELOPMENT (R&D). IT SUPPORTS BEST RESEARCH PRACTICES, THE DEVELOPMENT AND IMPLEMENTATION OF DATA QUALITY STANDARDS, PRECLINICAL DATA & TECHNOLOGICAL PLATFORMS, AND TRAINING PROGRAMS FOR THE NEUROSCIENCE COMMUNITY WITH THE GOAL OF ENHANCING THE DATA UTILITY DERIVED FROM PRECLINICAL MODELS. THIS IS OUR THIRD YEAR SUPPORTING WITH THE EUROPEAN COLLEGE OF NEUROPHARMACOLOGY (ECNP) THE WORLD'S FIRST NEGATIVE DATA PRIZE AS AN INCENTIVE FOR PRECLINICAL RESEARCHERS TO PUBLISH "NEGATIVE DATA" RESULTS TO ENSURE ALL NEUROSCIENCE STUDIES PROPERLY ADVANCE KNOWLEDGE. THE PRIZE IS AWARDED TO THE RESEARCHER OR RESEARCH GROUP WHOSE NEUROSCIENCE STUDY BEST EXEMPLIFIES DATA WHERE THE OUTCOMES DO NOT CONFIRM THE EXPECTED RESULTS OR WORKING HYPOTHESIS. THE AWARD WAS PRESENTED DURING THE 2020 VIRTUAL ECNP CONFERENCE.EQIPD QUALITY SYSTEM:THE GPDF AND COHEN VETERANS BIOSCIENCE ARE BOTH MAJOR CONTRIBUTORS TO THE EUROPEAN UNION INNOVATIVE MEDICINE INITIATIVE-FUNDED CONSORTIUM CALLED EQIPD (EQIPD.ORG). THE EQIPD CONSORTIUM HAS DEVELOPED A NOVEL PRECLINICAL RESEARCH QUALITY SYSTEM THAT CAN BE APPLIED IN BOTH PUBLIC AND PRIVATE SECTORS AND IS FREE FOR ANYONE TO USE. THE EQIPD QUALITY SYSTEM WAS DESIGNED TO BE SUITED TO BOOST INNOVATION BY ENSURING THE GENERATION OF ROBUST AND RELIABLE PRECLINICAL DATA WHILE BEING LEAN, EFFECTIVE AND NOT BECOMING A BURDEN THAT COULD NEGATIVELY IMPACT THE FREEDOM TO EXPLORE SCIENTIFIC QUESTIONS. EQIPD DEFINES RESEARCH QUALITY AS THE EXTENT TO WHICH RESEARCH DATA ARE FIT FOR THEIR INTENDED USE. FITNESS, IN THIS CONTEXT, IS DEFINED BY THE STAKEHOLDERS, WHO ARE THE SCIENTISTS DIRECTLY INVOLVED IN THE RESEARCH, BUT ALSO THEIR FUNDERS, SPONSORS, PUBLISHERS, RESEARCH TOOL MANUFACTURERS AND COLLABORATION PARTNERS SUCH AS PEERS IN A MULTI-SITE RESEARCH PROJECT. THE ESSENCE OF THE EQIPD QUALITY SYSTEM IS THE SET OF 18 CORE REQUIREMENTS THAT CAN BE ADDRESSED FLEXIBLY, ACCORDING TO USER-SPECIFIC NEEDS AND FOLLOWING A USER-DEFINED TRAJECTORY. THE EQIPD QUALITY SYSTEM PROPOSES GUIDANCE ON EXPECTATIONS FOR QUALITY-RELATED MEASURES, DEFINES CRITERIA FOR ADEQUATE PROCESSES (I.E., PERFORMANCE STANDARDS) AND PROVIDES EXAMPLES OF HOW SUCH MEASURES CAN BE DEVELOPED AND IMPLEMENTED. THE CONSORTIUM'S FIRST HANDBOOK PUBLISHED THIS YEAR:BESPALOV A, MICHEL MC, STECKLER T (EDS) HANDBOOK OF EXPERIMENTAL PHARMACOLOGY - GOOD RESEARCH PRACTICE IN NON-CLINICAL PHARMACOLOGY AND BIOMEDICINE, SPRINGER OPEN, CHAM, SWITZERLAND. ISBN 978-3-030-33655-4, EBOOK ISBN 978-3-030-33656-1 (2020). POLICY & ADVOCACY INITIATIVES:IN 2020, WE FORMALLY ESTABLISHED OUR DEPARTMENT OF POLICY AND ADVOCACY UNDER THE DIRECTION OF DR. CHANTELLE FERLAND-BECKHAM. WE ARE COMMITTED TO ADVOCATING FOR POLICY REFORMS AT THE FEDERAL LEVEL THAT BUILD UPON EVIDENCE-BASED PRECISION MEDICINE APPROACHES AND HAVE THE POWER TO BRING NEW SOLUTIONS FOR PTSD AND TBI IN YEARS, NOT DECADES. AS PART OF OUR ADVOCACY EFFORTS, WE CO-FOUNDED THE COALITION TO HEAL INVISIBLE WOUNDS (THE COALITION), A COLLABORATIVE INITIATIVE AIMED AT ADVOCATING FOR POLICY REFORMS TO WIDEN AND EXPEDITE THE PIPELINE FOR NEW THERAPIES AND DIAGNOSTICS FOR PTSD AND TBI-WHICH CAN BOTH DRASTICALLY INCREASE THE RISK OF SUICIDE AMONG VETERANS. THIS YEAR, WE MADE SIGNIFICANT PROGRESS ON THE COALITION'S LARGEST ADVOCACY PUSH-IMPROVING VETERANS' ACCESS TO CLINICAL TRIALS. VA CLINICAL TRIALS HAVE THE POTENTIAL TO BRING NEW PRECISION MEDICINE THERAPIES FOR PTSD AND TBI TO VETERANS, BUT VA FACILITIES OFTEN FACE CHALLENGES INITIATING AND COMPLETING CLINICAL TRIALS, MEANING THAT MANY CLINICAL TRIAL SPONSORS DO NOT ATTEMPT TO BRING TRIALS TO THE VA AND HAVE NOT DONE SO FOR YEARS. WE, LIKE MANY OTHERS, BELIEVE THAT THE VA CAN BE A LEADER IN CLINICAL RESEARCH AND HAVE COMMITTED TO SUPPORTING THE VA THROUGH THE "100 DAYS FASTER" INITIATIVE, AN INITIATIVE SPEARHEADED THROUGH OUR ADVOCACY EFFORTS WITH THE COALITION AND SUPPORTED AND ENDORSED BY BOTH THE NATIONAL ASSOCIATION OF VETERANS RESEARCH AND EDUCATION FOUNDATIONS (NAVREF) AND THE VA OFFICE OF RESEARCH AND DEVELOPMENT (ORD). EARLIER THIS YEAR, TWO OF THE COALITIONS TOP PRIORITIES OF THE "100 DAYS FASTER" INITIATIVE WERE INCORPORATED INTO A LARGER COMPREHENSIVE LEGISLATIVE PACKAGE CALLED THE COMMANDER JOHN SCOTT HANNON VETERANS MENTAL HEALTH CARE IMPROVEMENT ACT OF 2019 (S. 785). THIS IMPORTANT BILL WHICH PASSED INTO LAW IN OCTOBER, WILL IMPROVE VETERANS' ACCESS TO INNOVATIVE MENTAL HEALTH CARE AND MAKE NECESSARY INVESTMENTS INTO SUICIDE PREVENTION. CVB, AS PART OF THE COALITION, SPECIFICALLY ADVOCATED FOR FOUR PROVISIONS IN THE BILL. SECTIONS 704 AND 705 ARE AIMED AT IMPROVING VETERANS ACCESS TO CUTTING-EDGE CLINICAL TRIALS AT THE VA AS PART OF THE COALITION TO HEAL INVISIBLE WOUNDS' "100 DAYS FASTER INITIATIVE." SECTION 305 WOULD CREATE THE "PRECISION MEDICINE FOR VETERANS INITIATIVE," TO BE MODELED AFTER THE ALL OF US PRECISION MEDICINE INITIATIVE. FINALLY, SECTION 306 WOULD ENABLE THE VA TO CONDUCT ADVANCED DATA ANALYTICS, AN ESSENTIAL CAPABILITY ACROSS THE MEDICAL FIELD FOR ADVANCING RESEARCH AND IDENTIFYING NEW DIAGNOSTIC AND THERAPEUTIC CANDIDATES. AS ANOTHER IMPORTANT STEP TOWARDS "100 DAYS FASTER," CVB IS ALSO EXTENDING ITS COMMITMENT TO THE BRAIN HEALTH OF VETERANS BY SUPPORTING NAVREF AND THE NEW VA ORD-LED PARTNERED RESEARCH PROGRAM (PRP). AS AN OUTCOME OF THE ACCESS TO CLINICAL TRIALS (ACT) FOR VETERANS INITIATIVE, THE PRP INCREASES VETERANS' ACCESS TO HIGH-QUALITY CLINICAL TRIALS AND STREAMLINES THE START-UP OF NEW INNOVATIVE TRIALS, GIVING VETERANS ACCESS TO WORLD-CLASS HEALTH SOLUTIONS. THE PRP IS HELPING AGENCIES AND ORGANIZATIONS TO PARTNER MORE RAPIDLY ON CRITICAL RESEARCH TRIALS, SPECIFICALLY TARGETING THE ENHANCED INCLUSION OF VETERANS. AS A RESULT OF CRITICAL PROCESS CHANGES PUT INTO PLACE ON MARCH 3RD OF THIS YEAR, A DIRECT RECOMMENDATION OF THE "100 DAYS FASTER" INITIATIVE, WHEN THE COVID-19 PANDEMIC HIT, THE VA WAS WELL PREPARED TO MEET THE CHALLENGE AND SHOWED SIGNIFICANT PROGRESS IN INITIATING NEW CLINICAL TRIALS AT THE VA IN MERE DAYS, NOT MONTHS.

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