2020-10-26T09:33:08-05:00 2020-06-30 431985162 SMITH SULLIVAN & BROWN PC 80 FLANDERS ROAD - SUITE 200 WESTBOROUGH MA 01581 990 2019-07-01 471981973 COHEN VETERANS BIOSCIENCE INC COHE 6469704325 1 BROADWAY 14TH FLOOR CAMBRIDGE MA 02142 MAGALI HAAS MD PHD CEO & PRESIDENT 6469704325 2020-10-26 1 SANDRA M BROWN CPA P01614103 5088717178 2020-10-26 71.248.188.134 2020-10-26 10:31:57 ED P 69E9977AC052CEB93F1ED3E2D4B07C277CAC5DE2 69E9977AC052CEB93F1ED3E2D4B07C277CAC5DE2 2019 2021-01-29 14:40:06Z MAGALI HAAS MD PHD 1 BROADWAY 14TH FLOOR CAMBRIDGE MA 02142 16470665 0 X WWW.COHENVETERANSBIOSCIENCE.ORG X 2014 MA FAST-TRACKING PRECISION DIAGNOSTICS AND PERSONALIZED THERAPEUTICS FOR ADVANCING BRAIN HEALTH 5 2 35 0 0 0 20795052 16316026 0 0 98872 154639 145524 0 21039448 16470665 2786841 1112861 0 0 4994068 7099520 0 0 27526 12390028 9950539 20170937 18162920 868511 -1692255 24190269 18865456 12988921 8431760 11201348 10433696 X 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. 0 0 15387411 1112861 0 BRAIN HEALTH PLATFORMSIN ORDER TO FAST-TRACK PRECISION DIAGNOSTICS AND PERSONALIZED THERAPEUTICS AND WELLNESS APPROACHES FOR MAINTENANCE AND RESTORATION OF BRAIN HEALTH, CVB IS LEVERAGING INNOVATION AND TECHNOLOGY TO BUILD PLATFORMS THAT ENABLE DISCOVERY AND DEVELOPMENT ACROSS BRAIN DISEASES. THESE PLATFORMS ALLOW RESEARCHERS FROM ACADEMIA AND INDUSTRY TO ACCESS AND UTILIZE BEST-IN-CLASS TOOLS AND ALLOW EFFORTS TO BE SCALED WITH RIGOR AND REPRODUCIBILITY.(SEE SCHEDULE O FOR FULL DETAIL OF OUR PROGRAMS)PLATFORM EFFORTS FOCUS ON CAPACITY THAT ENABLES RELIABLE DISCOVERY OF BIOMARKERS AND BIOLOGICAL PATHWAYS THAT ARE TRANSLATIONALLY RELEVANT FOR THE DEVELOPMENT OF DIAGNOSTICS AND THERAPEUTIC TARGETS FOR DRUG AND OTHER MEDICAL INTERVENTIONS. EACH PLATFORM IS CREATING RESEARCH TOOLS (E.G. ANIMAL MODELS, DATA STANDARDS, COMPUTATIONAL MODELS, REFERENCE DATABASES, ETC.) THAT WILL ACCELERATE/FOSTER THESE DISCOVERIES. WITHIN THIS FRAMEWORK, CVB HAS ESTABLISHED BOTH INTRAMURAL (RESEARCH CONDUCTED BY, OR INCLUDING, CVB STAFF OR CONTRACTORS) AND EXTRAMURAL RESEARCH PROGRAMS (RESEARCH CONDUCTED VIA GRANTS OR IN COLLABORATION WITH EXTERNAL ACADEMIC, INDUSTRY, FOUNDATION AND GOVERNMENT PARTNERS) AND ALSO OPERATES SEVERAL PUBLIC-PRIVATE PARTNERSHIPS. THESE COOPERATIVE ALLIANCES ORGANIZE AND FUND A NETWORK OF PARTNERS WHO EACH CONTRIBUTE COMPLEMENTARY AND SYNERGISTIC DATA, CAPABILITIES, OR EXPERTISE TO SUPPORT A COMMON ROADMAP FOR IDENTIFYING DIAGNOSTIC BIOMARKERS, BUILDING PREDICTIVE BRAIN DISEASE MODELS, DEVELOPING ROBUST STANDARDIZED TRANSLATIONAL TOOLS, AND CATALYZING PHARMACEUTICAL DRUG DEVELOPMENT. THE EMPHASIS IS ON TEAM SCIENCE WITH COHEN VETERANS BIOSCIENCE SERVING AS ITS HUB.OUR PLATFORM PROGRAMS CURRENTLY INCLUDE THE BRAIN COMMONS (CLOUD-BASED DATA SHARING), EARLYSIGNAL (WEARABLE AND HOME SENSORS FOR MONITORING HEALTH STATUS), RAPID-DX (ESTABLISHING BEST PRACTICES FOR DISCOVERY AND VALIDATION OF BIOMARKERS) AND BRAIN-NET (A CLINICAL TRIAL INFRASTRUCTURE TO EXECUTE TURN-KEY EARLY PHASE CLINICAL STUDIES).BRAIN COMMONS (TRADEMARKED):BUILDING ON PREVIOUS WORK WITH THE OPEN COMMONS CONSORTIUM AND UNIVERSITY OF CHICAGO, CVB HAS CREATED A CLOUD-ACCESSIBLE AND SECURE DIGITAL ECOSYSTEM TO ENABLE AND STIMULATE DATA SHARING AND ANALYSIS IN BOTH PUBLIC AND PRIVATE DOMAINS, FUELING DISCOVERY AND COLLABORATION ACROSS THE MULTIDISCIPLINARY RESEARCH COMMUNITY, AND DRIVING DIAGNOSTIC AND THERAPEUTIC INNOVATION TO REDUCE THE BURDEN OF BRAIN-BASED DISORDERS. LEADING BRAIN-RELATED DISEASE FOUNDATIONS HAVE ACCESS TO THE PLATFORM TO HOUSE THEIR OWN DATA WITHIN THE COMMONS. EARLYSIGNAL (TRADEMARKED): WEARABLE AND SENSOR TECHNOLOGIES HOLD PROMISE IN THE ASSESSMENT AND CONTINUOUS MONITORING OF PATIENTS IN ORDER TO BETTER SCREEN AND DIAGNOSE, MONITOR DISEASE PROGRESSION, AND OBSERVE INTERVENTION RESPONSE OR LACK THEREOF. DIGITAL HEALTH MONITORING ALSO ALLOWS US TO STUDY BRAIN HEALTH AND DISEASE IN UNPRECEDENTED WAYS, BY TRACKING VARIABLES SUCH AS SLEEP, PHYSICAL ACTIVITY, STRESS AND COGNITION, WE MAY BE ABLE TO BETTER UNDERSTAND WHAT CHANGES OVER TIME - AND TO DEVELOP EARLIER AND PREVENTIVE DIAGNOSTICS AND TREATMENTS TO MAKE A DIFFERENCE IN PATIENTS' LIVES. MEDICAL-GRADE DATA IS NEEDED FOR FDA APPROVAL OF SUCH PLATFORMS FOR USE IN MEDICAL DECISION MAKING AND DATA INTEGRATION IS NECESSARY FOR CLINICIANS' WORKFLOW. THIS PROGRAM SUPPORTS MULTIPLE PARTNERS TO TEST AND VALIDATE WEARABLES, SENSORS, APPS AND OTHER DIGITAL HEALTH TECHNOLOGIES FOR USE IN MONITORING BRAIN HEALTH. A CURRENT EXAMPLE OF SUCH WORK IS CVB'S PARTNERSHIP WITH UNIVERSITY OF PENNSYLVANIA, CONDUCTING A STUDY TO TEST AND VALIDATE THE PERFORMANCE OF WEARABLE AND SENSOR DEVICES, USING CVB DESIGNED SECURE AUTOMATED DEIDENTIFIED DATA COLLECTION AND CVB'S STUDY MANAGER TOOL TO SUPPORT CONDUCT OF THE TRIAL.RAPID-DIAGNOSTICS (RAPID-DX (TRADEMARKED)):A BIOMARKER IS A CHARACTERISTIC THAT IS OBJECTIVELY MEASURED AND EVALUATED AS AN INDICATOR OF A NORMAL OR PATHOLOGIC BIOLOGICAL PROCESS OR A RESPONSE TO A THERAPEUTIC INTERVENTION DEVELOPING BIOMARKER-BASED DIAGNOSTICS IS ESSENTIAL TO SHIFTING DIAGNOSIS AND TREATMENT OF PSYCHIATRIC AND NEUROLOGIC CONDITIONS (SUCH AS PTSD AND TBI) FROM A SYNDROMIC OR SYMPTOM-BASED APPROACH TO A BIOLOGICAL, MECHANISTICALLY-BASED ONE THAT TARGETS THE EFFECTS OF TRAUMA AT THEIR MOLECULAR ROOTS. MANY POTENTIAL BRAIN-RELATED BIOMARKERS PUBLISHED IN THE LITERATURE HAVE NOT BEEN INDEPENDENTLY REPLICATED OR ADVANCED THROUGH A QUALIFICATION PROCESS FOR REGULATORY APPROVAL AND USE.RAPID-DX IS A PUBLIC-PRIVATE PARTNERSHIP PROGRAM INCLUDING GOVERNMENT, FOUNDATIONS, AND LEADING ACADEMIC CENTERS ESTABLISHED FOR COLLECTING DATA AND PERFORMING STUDIES NECESSARY TO DISCOVER AND REPLICATE BIOMARKERS AND QUALIFY SUCCESSFUL AND RELEVANT CANDIDATES FOR DEVELOPMENT AS CLINICAL DIAGNOSTICS.THROUGH THIS PROGRAM CVB HAS ESTABLISHED THE CVB BRAIN BIOREPOSITORY IN PARTNERSHIP WITH INDIANA UNIVERSITY. THE GOAL OF THE BIOREPOSITORY IS TO ESTABLISH A CENTRALIZED RESOURCE FOR TISSUE AND BIOSAMPLE STORAGE FOR ENABLING BIOMARKER DISCOVERY, REPLICATION, AND VALIDATION ACROSS A NUMBER OF BRAIN CONDITIONS, INCLUDING POST-TRAUMATIC STRESS DISORDER (PTSD), TRAUMATIC BRAIN INJURY (TBI), SUICIDE, DEMENTIA, MAJOR DEPRESSIVE DISORDER AND OTHER MENTAL HEALTH DISORDERS, AMONG OTHERS.THE CVB BRAIN BIOREPOSITORY HOUSES BLOOD AND SALIVA SAMPLES THAT WERE COLLECTED AS PART OF BIOMARKER STUDIES DIRECTLY SPONSORED BY COHEN VETERANS BIOSCIENCE OR THROUGH KEY PARTNERSHIP PROGRAMS. OUR BIOREPOSITORY BANKS A VARIETY OF BIOLOGIC SAMPLES INCLUDING, PLASMA, SERUM, AND SALIVA, AND WILL ENCOURAGE FUTURE COLLABORATIONS WITH RESEARCHERS FROM ACADEMIA, INDUSTRY, GOVERNMENT AND FOUNDATIONS.IN 2020, CVB COMPLETED AND PUBLISHED OUR CROSS-PLATFORM COMPARISON OF HIGHLY SENSITIVE IMMUNOASSAY TECHNOLOGIES FOR CYTOKINE MARKERS. THIS 'BAKE-OFF' STUDY IS THE FIRST IN A SERIES THAT EVALUATES THE PERFORMANCE OF FLUID-BASED ASSAYS. THE ROLE OF INFLAMMATION AND THE IMMUNE SYSTEM ACROSS NEUROPSYCHIATRIC AND NEURODEGENERATIVE DISEASES IS IMPORTANT TO UNDERSTAND, AND DEPENDS ON AN ABILITY TO MEASURE, WITH PRECISION, CYTOKINES IN THE VARIOUS FLUIDS INCLUDING BLOOD, CEREBRO-SPINAL FLUID (CSF), AND SALIVA.OUR PROGRAM BLINDLY EVALUATED FIVE LEADING IMMUNOASSAY PLATFORM'S ABILITY TO ACCURATELY AND REPRODUCIBLY MEASURE SELECTIVE ANALYTES IN PLASMA AND SERUM WERE OBTAINED FROM HEALTHY CONTROLS AND CLINICAL POPULATIONS (PTSD AND PARKINSONS). WE FOUND THAT PLATFORM PERFORMANCE WAS HIGHLY VARIABLE, PARTICULARLY FOR LOW-ABUNDANT CYTOKINES. THESE FINDINGS HIGHLIGHT WHAT METRICS SHOULD BE TAKEN INTO ACCOUNT IN SELECTING IMMUNOASSAYS IN FUTURE RESEARCH. THE PROGRAM WAS CO-FUNDED BY THE MICHAEL J FOX FOUNDATION.BRAIN-NET (TRADEMARKED):DRUG DEVELOPMENT IS COSTLY, TIME-CONSUMING, AND INEFFICIENT. MANY OPPORTUNITIES EXIST TO IMPROVE OPERATIONAL EXCELLENCE, TRIAL DESIGN, AND PATIENT RECRUITMENT. CVB IS ESTABLISHING A WELL-FUNDED, WELL-TRAINED, FAST-START, STANDING NETWORK OF BRAIN-RELATED CLINICAL TRIAL SITES WOULD PROMOTE THE DEVELOPMENT OF NEW AGENTS FOR BRAIN CONDITIONS SUCH AS PTSD, MDD, ANXIETY, CHRONIC EFFECTS OF TBI TO REDUCE TIME AND COSTS ASSOCIATED WITH DRUG DEVELOPMENT. THIS NETWORK WILL HAVE A FOCUS ON PRECISION THERAPEUTICS APPROACHES AND WILL IMPLEMENT CAPABILITIES FROM OUR OTHER PLATFORMS.BRAIN TRAUMA PROGRAMS: POST TRAUMATIC STRESS DISORDER ("PTSD") AND TRAUMATIC BRAIN INJURY ("TBI"):IN 2015, THIS CVB PROGRAM WAS FOUNDED TO ESTABLISH A NATIONAL RESEARCH ROADMAP FOR PTSD, TBI AND RELATED CONDITIONS (E.G. SUICIDALITY). BRAIN TRAUMA BLUEPRINT - STATE OF THE SCIENCE SUMMITS:THE BRAIN TRAUMA BLUEPRINT IS A SERIES OF STATE OF THE SCIENCE SUMMITS AIMED TO BUILD CONSENSUS AROUND KNOWLEDGE GAPS AND DEVELOP STRATEGIES TO MOVE THE FIELD FORWARD FOR TRAUMA-RELATED CONDITIONS BY LEVERAGING THE COMBINED INTELLECTUAL RESOURCES OF THE FULL RESEARCH COMMUNITY.THE STATE OF THE SCIENCE SUMMITS ARE DESIGNED AS RETREATS FOR 100 TO 200 STAKEHOLDERS TO COME TOGETHER TO REALIZE TRUE IMPACT. THE STAKEHOLDERS ENCOMPASS A BROAD SWATH OF THE COMMUNITY FROM ACADEMIC INSTITUTIONS TO GOVERNMENT AGENCIES, FOUNDATIONS SUPPORTING TRANSLATIONAL RESEARCH, AND INDUSTRY.EACH SUMMIT SERVES AS A LAUNCHPAD FOR ONGOING WORKING GROUPS TO DEVELOP EVIDENCE-BASED STRATEGIES AND RECOMMENDATIONS ON HOW TO FILL THOSE GAPS, IDENTIFY NEW GAPS AS OTHERS ARE FILLED, AND DISSEMINATE THESE FINDINGS BACK TO THE COMMUNITY AT LARGE THROUGH WHITE PAPERS AND PROCEEDINGS.THE INAUGURAL STATE OF THE SCIENCE, HELD IN 2018, FOCUSED ON DIAGNOSIS OF TRAUMA-RELATED BRAIN DISORDERS WITH A MAJOR FOCUS ON POST-TRAUMATIC STRESS DISORDER. THE TRAUMA-RELATED BRAIN DISORDERS RESEARCH COMMUNITY HAS IDENTIFIED A NEED TO ESTABLISH A MECHANISM-BASED TAXONOMY FOR THESE CONDITIONS TO ADVANCE BIOMARKER DISCOVERY AS WELL AS DIAGNOSIS AND THERAPEUTIC DEVELOPMENT. 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. 15387411 1 1 0 1 0 0 0 0 0 0 1 0 0 0 1 1 1 0 0 1 1 1 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 1 34 0 35 1 0 0 0 0 0 0 0 0 0 0 0 0 X 5 2 0 0 0 0 0 0 0 1 1 0 0 1 1 1 1 1 1 1 1 0 MA NY X X GELMAN ROSENBERG AND FREEDMAN CPA 3019519090 4550 MONTGOMERY AVENUE SUITE 650N BETHESDA MD 20814 MAGALI HAAS MD PHD CEO & PRESIDENT 60.00 X X 635876 0 18315 THERESA FRANGIOSA SECRETARY 9.00 X X 0 0 0 MICHAEL SULLIVAN TREASURER 1.00 X X 0 0 0 DAVID BIONDI BOARD MBR/FORMER EXECUTIVE DIR.,CLINICAL PROGRAMS 40.00 X 310381 0 28337 DOUGLAS HAYNES BOARD MEMBER 1.00 X 0 0 0 DANIEL PLOWDEN CHIEF FINANCIAL OFFICER 40.00 X 49221 0 5568 ANDREAS JEROMIN PHD CHIEF SCIENTIFIC OFFICER 40.00 X 467198 0 15766 ALLYSON GAGE PHD CHIEF MEDICAL OFFICER 40.00 X 502457 0 23900 DANIELA BRUNNER PHD FORMER EXEC. 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OF DIGITAL HEALTH 40.00 X 317293 0 10182 DEEPTI COLE ASSOCIATE DIRECTOR, DATA SCIENCE 40.00 X 140990 0 8583 LINDA DYSON FORMER EXECUTIVE DIRECTOR, PUBLIC AFFAIRS 40.00 X 191178 0 4977 AMANDA NICOLE HARMON EXECUTIVE DIRECTOR, EXTERNAL AFFAIRS 40.00 X 231920 0 32407 FRISO POSTMA FORMER SENIOR DIRECTOR, EARLY SIGNAL 40.00 X 202304 0 12747 3048818 0 160782 22 0 1 0 MORGAN LEWIS AND BOCKIUS LLP 1701 MARKET STREET PHILADELPHIA PA 19103 LEGAL SERVICES 654428 GRF CPA'S & ADVISORS 4550 MONTGOMERY AVENUE SUITE 800 NORTH BETHESDA MD 20814 ACCOUNTING AND BOOKKEEPING 367411 DEEP NET AI LTD 12 MANOR FIELDS ALREWAS BURTON ON STRAFFORD DEDA UK CHIEF INFORMATION OFFICER 314557 ADVANCED STRATEGIC TECHNOLOGY LLC 6 DIGITAL DRIVE UNIT 302 NASHUA NH 03062 STRATEGIC IT ADVISOR 190108 TONE CREATIVE LLC 63 PUTNUM STREET SUITE 2020 SARATOGA SPRINGS NY 12866 MARKETING AND DESIGN SERVICES 179815 16 1994444 14321582 16316026 154639 154639 16470665 0 0 154639 X 1043394 1043394 69467 69467 2230230 1791228 432175 6827 3990660 3586290 403318 1052 229268 200336 28764 168 278835 238418 40021 396 370527 320048 50011 468 289832 289832 673696 254639 419057 515166 515166 90000 90000 6664905 6514137 132754 18014 326849 198468 128289 92 200906 139845 61006 55 580439 470196 110243 404045 296367 107338 340 104052 95784 8268 44776 37943 6778 55 55798 40851 14888 59 BAD DEBT EXPENSE 75 75 18162920 15387411 2747983 27526 465961 690470 16036550 15130098 7527477 2302389 61526 88022 319955 35637 50226 284318 48529 370159 24190269 18865456 2672945 2942644 10118262 5348290 197714 9022 0 131804 12988921 8431760 X 840992 3045971 10360356 7387725 11201348 10433696 24190269 18865456 X -1692255 924603 X X 0 1 X 1 0 X 31399759 4366629 16828176 20795052 16316026 89705642 31399759 4366629 16828176 20795052 16316026 89705642 80250238 9455404 17365 98872 154639 270876 89976518 0.10510 X COHEN VETERANS BIOSCIENCE, INC. ("CVB") IS A PUBLIC CHARITY DEDICATED TO FAST-TRACKING THE DEVELOPMENT OF DIAGNOSTIC TESTS AND PERSONALIZED THERAPEUTICS FOR THE MILLIONS OF VETERANS AND CIVILIANS IN THE US WHO SUFFER THE DEVASTATING EFFECTS OF TRAUMA-RELATED AND OTHER BRAIN DISORDERS. GLOBALLY, 2 BILLION INDIVIDUALS ARE DIRECTLY AFFECTED BY BRAIN DISORDERS. THE WORLD HEALTH ORGANIZATION ATTRIBUTES 38% OF THE TOTAL YEARS LOST TO DEATH AND DISABILITY TO BRAIN DISORDERS, A FIGURE WELL AHEAD OF THE NEXT-CLOSEST AND HIGHER-PROFILE DISEASES OF CANCER (12.7%) AND CARDIOVASCULAR DISEASE (11.8%). THIS MEMO PROVIDES EVIDENCE OF QUANTITATIVE AND QUALITATIVE MEASURES WHICH SUPPORT CONTINUED PUBLIC CHARITY STATUS. CVB MEETS THE QUANTITATIVE PERCENTAGE TEST CRITERION FOR SUPPORTING FACTS AND CIRCUMSTANCES. CVB ENGAGES WITH AND MAKES AVAILABLE TO RESEARCHERS, POLICY MAKERS, AND THE GENERAL PUBLIC A BROAD ARRAY OF PROGRAMS, TOOLS, SERVICES, AND INFORMATION WHICH ADVANCE THE STATE OF BRAIN SCIENCE, GUIDED BY AN INDEPENDENT BOARD AND ADVISORY COUNSELS IN CONJUNCTION WITH CVB'S RENOWNED EXPERTS IN RELEVANT FIELDS OF NEUROSCIENCE, DATA SCIENCE AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT. FOLLOWING ARE MORE DETAILED EVIDENCE OF THESE FACTS AND CIRCUMSTANCES. COHEN VETERANS BIOSCIENCE, INC. EARLY ORIGINS WERE AS AN ORGANIZATION UNDER THE FISCAL SPONSORSHIP OF THE MARIN COUNTY COMMUNITY FOUNDATION, LATER ESTABLISHED AS A STAND-ALONE 501(C)3 IN 2014 UNDER THE NAME ORION BIONETWORKS. CVB'S FOUNDER AND CEO HAS A PERSONAL CONNECTION TO THE PUBLIC WORK THE ORGANIZATION CARRIES OUT BY VIRTUE OF HER HUSBAND BEING A VETERAN OF THE US AIRFORCE SERVICE AND HER SISTER SERVING AS AN AIRFORCE COLONEL, WITH ACTIVE DEPLOYMENTS TO OEF/OIF. THE FORMAL NAME CHANGE TO COHEN VETERANS BIOSCIENCE TOOK PLACE IN 2015 IN CONCERT WITH GENEROUS SEED FUNDING FROM STEVEN A. COHEN. CVB QUALIFIES AS A PUBLIC CHARITY UNDER THE "FACTS AND CIRCUMSTANCES" TEST OF 1.170A-9(F)(3) OF THE TREASURY REGULATIONS, BASED UPON THE FOLLOWING:CVB IS ORGANIZED AND OPERATED SO AS TO ATTRACT NEW AND ADDITIONAL FUNDING ON A CONTINUOUS AND BONA FIDE BASIS; CVB HAS HAD A DONATION BUTTON ON WEBSITE AND ALL SOCIAL MEDIA SINCE INCEPTION. THE ORGANIZATION HAS RUN SEVERAL ONLINE DONATION CAMPAIGNS INCLUDING A "CROWDSOURCED" APPROACH IN 2017 THAT RAISED MORE THAN $100,000 FROM NUMEROUS INDIVIDUAL DONORS. THE ORGANIZATION HAS ACTIVELY PURSUED AND RECEIVED GRANTS FROM GOVERNMENT AND PUBLIC CHARITIES AND FOUNDATIONS FOCUSED ON BRAIN DISEASES. IN CVB'S EARLY YEARS OF EXISTENCE THE SCOPE OF ITS SOLICITATION WAS MORE LIMITED TO PERSONS DEEMED MOST LIKELY TO PROVIDE EARLY FUNDING IN AN AMOUNT SUFFICIENT TO ENABLE IT TO COMMENCE ITS CHARITABLE ACTIVITIES AND EXPAND THE SOLICITATION PROGRAM. DIRECT OUTREACH TO POTENTIAL SUPPORTERS IS INCREASINGLY CONDUCTED BY CVB'S CEO AND OTHER EXECUTIVE TEAM AND SCIENTIFIC STAFF. CVB NOW REGULARLY CONDUCTS BROAD OUTREACH CAMPAIGNS, HAS STAFF DEDICATED TO FUNDRAISING AND SUPPORTER ENGAGEMENT TO SOLICIT CHARITABLE CONTRIBUTIONS FROM THE GENERAL PUBLIC, AND CARRIES ON ACTIVITIES DESIGNED TO ATTRACT SUPPORT FROM GOVERNMENT SOURCES AND PUBLIC CHARITIES. IN THE MOST RECENT FISCAL YEAR CVB HIRED AN EXPERIENCED EXECUTIVE DIRECTOR OF DEVELOPMENT TO FURTHER EXPAND FUNDRAISING INFRASTRUCTURE AND OUTREACH. CVB REGULARLY APPLIES FOR RELEVANT FUNDING FROM GOVERNMENT AGENCIES AND NONPROFIT ORGANIZATIONS. CVB HAS DEVELOPED MATERIALS TO SUPPORT POTENTIAL DONOR ENGAGEMENT, AND WORKS DILIGENTLY TO EXPAND THE NETWORK OF POTENTIAL SUPPORTERS BY ENGAGING WITH BOARD MEMBERS AND STAFF TO CONNECT WITH THEM. CVB'S PUBLIC SUPPORT PERCENTAGE, AS REPORTED FOR 2019, IS 10.51%, AND IS EXPECTED TO INCREASE AS A RESULT OF EXPANDED FUNDRAISING INFRASTRUCTURE AND OUTREACH. THE 2019 RESULT WHEN COMPARED TO THE 2018 PERCENTAGE OF 8.94% IS EVIDENCE OF THE INCREASING BREADTH OF PUBLIC SUPPORT AS CVB FURTHER BUILDS UPON ITS FUNDRAISING EFFORTS. CVB HAS RECEIVED SUPPORT FROM A DIVERSITY OF DONORS AND SOURCES DURING ITS INITIAL START-UP PERIOD AND WILL CONTINUE TO EXPAND ITS DONOR BASE. DONORS INCLUDE US GOVERNMENT AGENCIES SUCH AS THE NATIONAL INSTITUTES OF HEALTH AND THE DEPARTMENT OF DEFENSE; A NUMBER OF NONPROFIT ORGANIZATIONS AND FOUNDATIONS INTERESTED IN MEDICAL RESEARCH AND ISSUES IMPACTING VETERANS; AND MORE THAN 100 INDIVIDUAL DONORS. CVB'S CURRENT FUNDRAISING PLANS ARE TARGETED AT A BROAD BASE OF DONORS, INCLUDING FOUNDATIONS, INDIVIDUALS, AND GOVERNMENT AGENCIES. AS EVIDENCED BY THE EXTENSIVE PROGRAMS SPONSORED BY CVB SUPPORTING RESEARCH COLLABORATIONS AND SCIENTIFIC BEST PRACTICE ADOPTION, CVB REMAINS AN ORGANIZATION COMMITTED TO SERVING THE PUBLIC THROUGH ITS WORK. EXAMPLES WHICH DEMONSTRATE OUR COMMITMENT TO THE PUBLIC BENEFIT AND PUBLIC PARTICIPATION IN OUR EFFORTS INCLUDE CVB'S VETERANS ADVISORY COUNCIL, STATE OF THE SCIENCE SUMMITS, NUMEROUS EXPERT WORKSHOPS, ENSURING OUR RESEARCH IS PUBLISHED IN OPEN ACCESS PUBLICATIONS, AND DATA SHARING POLICIES ENCOURAGING RESEARCH COLLABORATION ACROSS ORGANIZATIONAL BOUNDARIES. CVB PROGRAM ACTIVITIES, WITH TEAM SCIENCE AND COLLABORATION AS A CORE BELIEF, PROVIDES DIRECT PUBLIC BENEFIT THROUGH ITS RESEARCH AND EDUCATIONAL ACTIVITIES. CVB SPEARHEADS RESEARCH WITH MULTI-SECTOR PARTNERS INCLUDING ACADEMIA, GOVERNMENT, FOUNDATION RESEARCH, AND INDUSTRY ORGANIZATIONS TO ADVANCE COLLECTIVE UNDERSTANDING OF AND APPROACHES TO IMPROVING BRAIN HEALTH. FOR EXAMPLE, CVB CO-SPONSORED THE PSYCHIATRIC GENETICS CONSORTIUM WITH THE BROAD INSTITUTE, THE LARGEST GENOME-WIDE ASSOCIATION STUDY META-ANALYSIS OF POST-TRAUMATIC STRESS DISORDER (PTSD) TO DATE. USING A MULTI-ETHNIC COHORT THAT INCLUDES OVER 30,000 PTSD CASES, 170,000 CONTROLS AND IS OVER TEN TIMES THE SIZE OF ANY PREVIOUS ANALYSIS, SIX GENETIC MARKERS FOR PTSD RISK WERE NEWLY DISCOVERED. CVB ALSO BROADLY DISSEMINATES RESEARCH AND EDUCATIONAL INFORMATION ABOUT PTSD, TRAUMATIC BRAIN INJURY (TBI) AND SUICIDE DIRECTLY TO THE PUBLIC THROUGH ITS WEBSITE AND SOCIAL MEDIA. THE INFORMATION IS PROVIDED IN AN ACCESSIBLE AND UNDERSTANDABLE FORMAT FOR ANY NON-MEDICAL READER, HELPING VETERANS AND OTHERS SUFFERING FROM PTSD OR TBI TO UNDERSTAND THEIR CONDITIONS AND THE SYMPTOMS AND CAUSES ASSOCIATED WITH THEM. THESE MATERIALS ALSO SERVE TO EDUCATE THE PUBLIC ABOUT PTSD AND TBI AND THE EFFECTS OF THESE CONDITIONS ON OUR VETERANS AND FAMILIES. THESE EVENTS, PROCEEDINGS, AND OTHER EDUCATIONAL OUTREACH SERVE TO ADVANCE BRAIN SCIENCE IN THE PUBLIC INTEREST. SEE WWW.COHENVETERANSBIOSCIENCE.ORG AND THE FORM 990 PROGRAM DESCRIPTIONS FOR MORE DETAILS ON THE EXPANSIVE NATURE OF THESE PROGRAMS. CVB ALSO ENLISTS THE ACTIVE SUPPORT AND PARTICIPATION OF EXPERTS, PUBLIC OFFICIALS, AND COMMUNITY LEADERS. CVB'S VETERANS ADVISORY COUNCIL ("VAC") INCLUDES SENIOR LEADERS WHO SERVED IN MILITARY LEADERSHIP ROLES AND/OR HAVE VETERAN FAMILY MEMBERS AND HAVE A DEEP PERSONAL COMMITMENT TO VETERANS' CONCERNS RELATED TO BRAIN HEALTH. VAC HELPS REPRESENT, ADVOCATE AND SUPPORT MILITARY AND VETERANS' INTERESTS TO CVB TO AID CVB IN DELIVERING MEANINGFUL RESULTS FOR VETERANS THROUGH DATA-DRIVEN SCIENCE AND ADVOCACY. MORE INFORMATION ABOUT VAC IS AVAILABLE HERE: HTTPS://WWW.COHENVETERANSBIOSCIENCE.ORG/VETERANS-ADVISORY-COUNCIL/ FINALLY, CVB HAS A REPRESENTATIVE GOVERNING BODY THROUGH ITS UNCOMPENSATED BOARD OF DIRECTORS CONSISTING OF FIVE MEMBERS WITH EQUAL VOTING RIGHTS. FOUR OF THE FIVE MEMBERS ARE INDEPENDENT OF THE LARGEST DONOR. ALL OF THE BOARD MEMBERS ARE INDIVIDUALS WITH SPECIAL KNOWLEDGE AND EXPERTISE RELEVANT TO THE ORGANIZATION'S CHARITABLE ACTIVITIES IN BRAIN SCIENCE AND HEALTH, AS WELL AS MEMBERS WITH LONGSTANDING DEDICATION TO THE NEEDS OF VETERANS AND OTHERS WHO SUFFER FROM BRAIN DISEASES THROUGH BOTH PAID AND UNPAID WORK WITH GOVERNMENT AND OTHER NONPROFIT AGENCIES. THE QUALIFICATIONS OF THE BOARD MEMBERS INCLUDE: BOARD CHAIR AND CEO, MAGALI HAAS, MD, PHD FOUNDED ORION BIONETWORKS (RENAMED TO COHEN VETERANS BIOSCIENCE IN 2015) WITH SPONSORSHIP FROM JANSSEN RESEARCH & DEVELOPMENT TO UNLOCK THE POWER OF SHARED DATA AND PREDICTIVE MODELING TO HELP TRANSFORM OUR UNDERSTANDING OF BRAIN DISEASES AND ACCELERATE THE SEARCH FOR CURES.DR. HAAS HAS OVER 20 YEARS OF PHARMACEUTICAL EXECUTIVE AND CLINICAL RESEARCH EXPERIENCE INCLUDING DEVELOPMENT LEADERSHIP ROLES IN MEDICAL MARKETING, FULL CLINICAL DEVELOPMENT, EARLY DEVELOPMENT, AND TRANSLATIONAL AND BIOMARKER SCIENCES IN PSYCHIATRY AND NEUROLOGY. DURING HER TENURE AT JOHNSON & JOHNSON, SHE SUCCESSFULLY FILED NDAS IN THE US AND EUROPE FOR RISPERIDONE INDICATIONS IN AUTISM, ADOLESCENT SCHIZOPHRENIA, JUVENILE BIPOLAR DISORDER AND CONDUCT DISORDERS. SHE ALSO LED DEVELOPMENT TEAMS EVALUATING COMPOUNDS FOR DEPRESSION, NEUROPATHIC PAIN, EPILEPSY, AND MIGRAINE DISORDER. PART II SECT C LINE 17A FACTS & CIRCUMSTANCES TEST (CONT): SHE SERVED 3 YEARS AS CHIEF SCIENCE AND TECHNOLOGY OFFICER FOR ONE MIND FOR RESEARCH, A NONPROFIT ORGANIZATION LAUNCHED IN MAY 2012 BY PATRICK J KENNEDY. SHE ORCHESTRATED THE LAUNCH OF ONE MIND'S SEMINAL PROGRAMS, APOLLO, AN INFORMATICS RESEARCH PORTAL AND, GEMINI, AN INTERNATIONAL TBI/PTSD RESEARCH PROGRAM. AS AN "INTRAPRENEUR" AT J&J SHE ESTABLISHED THE FIRST NEUROSCIENCE TRANSLATIONAL MEDICINE & INTEGRATIVE SOLUTIONS DEPARTMENT, AND CO-FOUNDED THE FIRST COMPANION DIAGNOSTICS CENTER OF EXCELLENCE AS WELL AS J&J'S HEALTHCARE INNOVATION TEAM. SHE SERVES ON SEVERAL ADVISORY BOARDS INCLUDING ALTO NEUROSCIENCE, KREMBIL CENTRE FOR NEUROINFORMATICS, VIRTUALBRAINCLOUD, PARTNERSHIP FOR ASSESSMENT AND ACCREDITATION OF SCIENTIFIC PRACTICE (PAASP) AND INTERUNIVERSITY MICROELECTRONICS CENTRE (IMEC) AN INTERNATIONAL RESEARCH & DEVELOPMENT AND INNOVATION HUB. DR. HAAS EARNED HER BS IN BIOENGINEERING FROM THE UNIVERSITY OF PENNSYLVANIA, AN MS IN BIOMEDICAL ENGINEERING FROM RUTGERS UNIVERSITY, NEW JERSEY, AND HER MD PHD WITH DISTINCTION IN NEUROSCIENCE FROM ALBERT EINSTEIN COLLEGE OF MEDICINE, NEW YORK. BOARD MEMBER, SECRETARY, THERESA FRANGIOSA HAS EXTENSIVE EXECUTIVE EXPERIENCED BASED ON HER 25 YEAR CAREER WITH THE PHARMACEUTICAL SECTOR. IN HER ROLES WITHIN PHARMA, SHE WAS A GLOBAL LAUNCH LEADER AS WELL AS OVERSEEING EARLY COMMERCIAL STRATEGY IN NEUROSCIENCES. SHE LED LARGE SCALE TEAMS, CROSS-FUNCTIONAL TEAMS TO DEFINE DISEASE AND THERAPEUTIC AREA STRATEGIES FOR JANSSEN AND GLAXOSMITHKLINE. SHE HAS ALSO LED INDICATION PRIORITIZATION EFFORTS AND DEVELOPMENT OF OVER 200 TARGET PRODUCT PROFILES OVER A VARIETY OF DISEASE STATES, LEVERAGING WELL-ESTABLISHED PROCESSES AND FRAMEWORKS, INCLUDING DEEPER UNDERSTANDING OF PATIENT JOURNEYS TO CREATE KEY INSIGHTS. SHE HAS APPLIED HER PROFESSIONAL CAREER EXPERIENCE AND HER PASSION FOR ADVOCACY TO HELP CREATE A CHANNEL FOR FEEDBACK FROM THOSE DIAGNOSED WITH OR AT RISK FOR ALZHEIMER'S DISEASE OR DEMENTIA, THEIR CARE PARTNERS AND INDIVIDUALS WHO ARE 'WORRIED WELL', CALLED THE A-LIST. SHE IS THE LEAD INVESTIGATOR FOR THIS RESEARCH STUDY WITH IRB OVERSIGHT. MS. FRANGIOSA OBTAINED HER BACHELOR OF ADMINISTRATION, ACCOUNTING CONCENTRATION FROM URSINUS COLLEGE (COLLEGEVILLE, PA) IN 1988 AND HER MASTERS OF BUSINESS ADMINISTRATION, PHARMACEUTICAL MARKETING FROM ST. JOSEPH'S UNIVERSITY IN 1996. BOARD MEMBER, DAVID BIONDI, MD HAS OVER 20 YEARS OF CLINICAL EXPERIENCE IN MEDICAL PRACTICE AND HELD MEDICAL DIRECTORSHIPS AT THE US NAVAL HOSPITAL IN OKINAWA JAPAN, THE PAIN MANAGEMENT PROGRAM & HEADACHE INSTITUTE AT MARYVIEW MEDICAL CENTER IN PORTSMOUTH VA, THE PAIN DIVISION OF THE MICHIGAN HEAD PAIN & NEUROLOGICAL INSTITUTE IN ANN ARBOR MI, AND THE INTERDISCIPLINARY HEADACHE & PAIN REHABILITATION PROGRAM AT SPAULDING REHABILITATION HOSPITAL IN BOSTON MA. HE WAS PREVIOUSLY AN ASSISTANT NEUROLOGIST AT THE MASSACHUSETTS GENERAL HOSPITAL AND AN INSTRUCTOR IN NEUROLOGY AT HARVARD MEDICAL SCHOOL. DR. BIONDI SERVED AS A TRUSTEE FOR THE UNIVERSITY OF NEW ENGLAND AND WAS CHAIR OF ITS ACADEMIC AND RESEARCH AFFAIRS COMMITTEE AND VICE-CHAIR OF ITS LONG-RANGE PLANNING COMMITTEE. HE ALSO SERVED AS A DIRECTOR AND MEDICAL ADVISOR FOR THE AFTER ACTION NETWORK, A NONPROFIT VETERAN SERVICE ORGANIZATION IN KANSAS CITY MO. HE IS A FELLOW OF THE AMERICAN ACADEMY OF NEUROLOGY. DR. BIONDI HAS OVER 15 YEARS OF EXPERIENCE IN CLINICAL RESEARCH AND DEVELOPMENT OF PHARMACEUTICALS AND MEDICAL DEVICES IN THE NEUROLOGY, PSYCHIATRY, AND PAIN THERAPEUTIC AREAS. HIS EXPERIENCES INCLUDE THE DESIGN, IMPLEMENTATION, MONITORING, AND INTERPRETATION OF PHASE 2 TO PHASE 4 CLINICAL TRIALS AND IN-HOUSE AND FIELD-BASED ACTIVITIES ASSOCIATED WITH INSIGHTS GENERATION, NEW BUSINESS OPPORTUNITIES, EMERGING HEALTH POLICY, KNOWLEDGE TRANSLATION AND IMPLEMENTATION, AND ORGANIZATIONAL EFFECTIVENESS. HE PREVIOUSLY SERVED AS EXECUTIVE DIRECTOR FOR CLINICAL PROGRAMS WITH COHEN VETERANS BIOSCIENCE. DR. BIONDI RECEIVED HIS MEDICAL DEGREE FROM THE UNIVERSITY OF NEW ENGLAND, COLLEGE OF OSTEOPATHIC MEDICINE IN BIDDEFORD ME. HE COMPLETED RESIDENCY TRAINING IN NEUROLOGY AT THE NATIONAL NAVAL MEDICAL CENTER IN BETHESDA MD AND IS BOARD-CERTIFIED IN NEUROLOGY WITH SUBSPECIALTY EXPERTISE IN HEADACHE AND PAIN MEDICINE. HE RECEIVED HIS BACHELOR OF SCIENCE - MAGNA CUM LAUDE IN PHARMACY FROM THE LONG ISLAND UNIVERSITY, SCHWARTZ COLLEGE OF PHARMACY & HEALTH SCIENCE IN BROOKLYN NY. BOARD MEMBER, TREASURER, MICHAEL C. SULLIVAN IS THE CHIEF OF STAFF AND HEAD OF EXTERNAL AFFAIRS OF POINT72 ASSET MANAGEMENT. MR. SULLIVAN PREVIOUSLY SERVED AS A SENIOR AIDE IN THE UNITED STATES SENATE, FOCUSING ON TELECOM, TECHNOLOGY, AND FINANCE ISSUES. MR. SULLIVAN ALSO SERVED AS A STAFF MEMBER IN THE U.S. HOUSE OF REPRESENTATIVES WORKING ON SIMILAR ISSUES. BEFORE COMING TO CAPITOL HILL, MR. SULLIVAN WAS THE HEAD OF STRATEGIC DEVELOPMENT FOR A TELECOMMUNICATIONS FOCUSED TRADE ASSOCIATION. MR. SULLIVAN IS INVOLVED WITH SEVERAL VETERANS' MENTAL HEALTH-RELATED NON-PROFIT ORGANIZATIONS. HE HELPED ESTABLISH AND SERVES ON THE BOARD AND AS TREASURER OF THE COHEN VETERANS NETWORK, WHICH OPERATES A NATIONAL NETWORK OF CLINICS TO TREAT VETERANS AND THEIR FAMILY MEMBERS AFFECTED BY POST-TRAUMATIC STRESS. MR. SULLIVAN IS AN ASSOCIATE AT THE NYU-STERN ENDLESS FRONTIER LABS, WHERE HE MENTORS START-UP COMPANIES IN ARTIFICIAL INTELLIGENCE, MACHINE LEARNING, AND RELATED FIELDS. HE IS ALSO A MEMBER OF THE EXECUTIVE COMMITTEE OF STUDENTS FIRST NEW YORK, A NONPROFIT ORGANIZATION ADVOCATING FOR EDUCATIONAL REFORM IN NEW YORK STATE. MR. SULLIVAN IS A GRADUATE OF VANDERBILT UNIVERSITY. BOARD MEMBER, DOUG HAYNES IS AN ACTIVE COMMUNITY MEMBER, DEDICATING A SIGNIFICANT PORTION OF HIS EFFORTS TO SUPPORTING VETERANS' INITIATIVES. IN ADDITION TO SERVING ON THE BOARD OF THE ROBIN HOOD FOUNDATION, MR. HAYNES HELPED LAUNCH ITS VETERANS ADVISORY BOARD WHICH RAISED OVER $12 MILLION TO SUPPORT THE INCREASE IN VETERANS RETURNING FROM IRAQ AND AFGHANISTAN, AND ALSO WORKS WITH NEW YORK-BASED COMPANIES TO CREATE MORE JOB OPPORTUNITIES FOR VETERANS. MR. HAYNES SERVES ON THE CORPORATE ADVISORY BOARD OF THE DARDEN GRADUATE SCHOOL OF BUSINESS, THE BOARD OF THE CANTERBURY SCHOOL, SINGTEL'S TECHNOLOGY ADVISORY BOARD, AND THE BOARD OF THE CENTER FOR GLOBAL ENTERPRISE. MR. HAYNES FORMERLY SERVED AS THE PRESIDENT OF POINT72 ASSET MANAGEMENT, L.P., ORIGINALLY JOINING THE FIRM AS MANAGING DIRECTOR OF HUMAN CAPITAL IN FEBRUARY 2014. PRIOR TO JOINING POINT72, MR. HAYNES WAS A DIRECTOR AT MCKINSEY & COMPANY. BEFORE JOINING MCKINSEY, MR. HAYNES WORKED FOR THE CENTRAL INTELLIGENCE AGENCY AND THEN GE'S ADVANCED MATERIALS BUSINESS. MR. HAYNES EARNED A BS SUMMA CUM LAUDE IN MECHANICAL ENGINEERING FROM WEST VIRGINIA UNIVERSITY, AND RECEIVED HIS MBA AT THE UNIVERSITY OF VIRGINIA'S DARDEN GRADUATE BUSINESS SCHOOL, WHERE HE WAS A SHERMET SCHOLAR. RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 90000 90000 18072920 18162920 1000000 250000 0 0 893383 1000000 1000000 2893383 4340075 90000 87500 90000 267500 223346 250000 250000 723346 1085019 134362 9834 124528 174076 19405 154671 11517 6398 5119 284318 DEFERRED RENT 131804 131804 X 16470665 0 16470665 0 16470665 18162920 0 18162920 0 18162920 PART X, LINE 2: TAX POSITION: THE ORGANIZATION CURRENTLY EVALUATES ALL TAX POSITIONS, AND MAKES A DETERMINATION REGARDING THE LIKELIHOOD OF THOSE POSITIONS BEING UPHELD UNDER REVIEW. THE PRIMARY TAX POSITION MADE BY THE ORGANIZATION IS THE EXISTENCE OF UNRELATED BUSINESS INCOME TAX AND THE ORGANIZATION'S STATUS AS A TAX-EXEMPT ORGANIZATION UNDER SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE. FOR THE YEAR PRESENTED, THE ORGANIZATION HAS NOT RECOGNIZED ANY TAX BENEFITS OR LOSS CONTINGENCIES FOR UNCERTAIN TAX POSITIONS BASED ON THIS EVALUATION. 1 EUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUM 0 0 GRANTS TO RECIPIENTS LOCATED IN REGION N/A 69467 EUROPE (INCLUDING ICELAND & GREENLAND) 0 1 CHIEF INFORMATION OFFICER N/A 322771 0 1 0 0 0 1 392238 0 392238 EUROPE (BELGIUM) HIGH-DENSITY RECORDING IN THE SPS MODEL OF PTSD 29467 WIRE TRANSFER N/A N/A EUROPE (GREECE) PLATFORM FOR THE EXCHANGE OF EXPERIMENTAL RESEARCH STANDARDS (PEERS) 40000 WIRE TRANSFER N/A N/A 1 1 0 0 0 0 0 0 PART I, LINE 2: THE ORGANIZATION REQUIRES GRANTEES TO REGULARLY PROVIDE QUALITATIVE AND QUANTITATIVE REPORTS DESCRIBING HOW FUNDS ARE BEING SPENT AND THE RESULTS THE GRANTEE HAS ACHIEVED. PROGRESS IS MEASURED AGAINST ORIGINAL AND REVISED GRANT PROPOSALS. CONTINUATION OF FUNDING IS DEPENDENT ON RESULTS AND ACCURATE, TIMELY REPORTING. PART III ACCOUNTING METHOD: 1 CHILDREN'S HOSPITAL OF PHILADELPHIA PO BOX 8500 PHILADEPHIA PA 19178 231352166 501(C)3 60000 N/A N/A VALIDATING CONSTRUCTS RELEVANT TO PTSD IN A MODEL OF INDIVIDUAL DIFFERENCES IN RESPONSE TO SOCIAL DEFEAT IN RATS MHEALTHFORWARD INC 315 W 36TH ST NEW YORK NY 10018 813198566 501(C)3 60000 N/A N/A BIOSENSORS AND MOBILE HEALTH PLATFORM FOR BRAIN DISEASES AMERICAN COLLEGE OF RADIOLOGY (ACR) 1818 MARKET ST STE 1720 PHILADELPHIA PA 19103 362261602 501(C)3 78055 N/A N/A CONDUCT STUDY TO ESTABLISH A NATIONAL NORMATIVE NEUROIMAGING LIBRARY UNIVERSITY OF CHICAGO 6054 SOUTH DREXEL AVE CHICAGO IL 60637 362177139 501(C)3 635748 N/A N/A PROVIDE SERVICES AND SUPPORT FOR BRAIN COMMONS (DATA-REPOSITORY) THE BROAD INSTITUTE OF MIT AND HARVARD 415 MAIN STREET CAMBRIDGE MA 02142 263428781 501(C)3 220784 N/A N/A PTSD RESEARCH PROGRAMS UNIVERSITY OF CALIFORNIA SAN DIEGO 9500 GILMAN DRIVE LA JOLLA CA 92093 956006144 501(C)3 40090 N/A N/A ANALYSIS OF GENETIC DATA (GWAS) IN PTSD PATIENTS OPEN COMMONS CONSORTIUM 400 LATHROP AVENUE SUITE 90 RIVER FOREST IL 60305 261866627 501(C)3 143811 N/A N/A BRAIN COMMONS DEVELOPMENT AND MAINTENANCE MCLEAN HOSPITAL 115 MILL STREET BELMONT MA 02142 042697981 501(C)3 -195094 N/A REPURPOSED GRANT FUNDS REPURPOSED GRANT FUNDS 7 0 PART I, LINE 2: THE ORGANIZATION REQUIRES GRANTEES TO REGULARLY PROVIDE QUALITATIVE AND QUANTITATIVE REPORTS DESCRIBING HOW FUNDS ARE BEING SPENT AND THE RESULTS THE GRANTEE HAS ACHIEVED. PROGRESS IS MEASURED AGAINST ORIGINAL AND REVISED GRANT PROPOSALS. CONTINUATION OF FUNDING IS DEPENDENT ON RESULTS AND ACCURATE, TIMELY REPORTING. X X X 0 0 0 0 0 0 0 0 0 MAGALI HAAS MD PHD CEO & PRESIDENT 454184 0 181692 0 0 0 18315 0 0 0 654191 0 0 0 DAVID BIONDI BOARD MBR/FORMER EXECUTIVE DIR.,CLIN 260031 0 50350 0 0 0 15334 0 13003 0 338718 0 0 0 ANDREAS JEROMIN PHD CHIEF SCIENTIFIC OFFICER 325470 0 141728 0 0 0 0 0 15766 0 482964 0 0 0 ALLYSON GAGE PHD CHIEF MEDICAL OFFICER 358257 0 144200 0 0 0 16822 0 7078 0 526357 0 0 0 DANIELA BRUNNER PHD FORMER EXEC. DIR. OF DIGITAL HEALTH 268264 0 49029 0 0 0 10182 0 0 0 327475 0 0 0 LINDA DYSON FORMER EXECUTIVE DIRECTOR, PUBLIC AF 191178 0 0 0 0 0 3462 0 1515 0 196155 0 0 0 AMANDA NICOLE HARMON EXECUTIVE DIRECTOR, EXTERNAL AFFAIRS 189253 0 42667 0 0 0 15561 0 16846 0 264327 0 0 0 FRISO POSTMA FORMER SENIOR DIRECTOR, EARLY SIGNAL 201304 0 1000 0 0 0 12747 0 0 0 215051 0 0 0 FRANGIOSA & ASSOCIATES OWNER IS AN OFFICER OF THE ORGANIZATION 46350 PROVIDED DISCOUNTED PHARMACEUTICAL MARKET, COMMERCIALIZATION LANDSCAPING AND STRATEGIC CONSULTING SERVICES TO ORGANIZATION. 0 FORM 990, PART VI, SECTION B, LINE 11B THE BOARD OF DIRECTORS REVIEWED AND APPROVED THE FORM 990 PRIOR TO ITS FILING. THE FORM 990 WAS THEN AUTHORIZED AND SIGNED BY THE ORGANIZATION'S CEO & PRESIDENT. FORM 990, PART VI, SECTION B, LINE 12C THE BOARD OF DIRECTORS REQUIRES AN ANNUAL DECLARATION FROM ALL BOARD MEMBERS AND SENIOR MANAGEMENT AS TO THE EXISTENCE AND DISCLOSURE OF ANY POTENTIAL CONFLICTS OF INTEREST. THE BOARD MEMBERS SIGN A DISCLOSURE STATEMENT. ANY POTENTIAL CONFLICTS ARE DISCUSSED BY THE DIS-INTERESTED BOARD MEMBERS, WHILE THE PARTY IN POTENTIAL CONFLICT IS REQUIRED TO LEAVE THE ROOM. BOARD MEETING MINUTES WILL DOCUMENT THE DISCUSSION AND DECISION MAKING PROCESS. IN THE EVENT OF A POTENTIAL CONFLICT, PROCEDURES TO OBTAIN COMPETITIVE BIDS AND DILIGENCE ON FAIR MARKET VALUE WILL BE ESTABLISHED. FORM 990, PART VI, SECTION B, LINE 15 CVB'S EXECUTIVE COMPENSATION PROGRAM IS ADMINISTERED BY THE BOARD OF DIRECTORS. THE BOARD IS RESPONSIBLE FOR ESTABLISHING AND MAINTAINING A COMPETITIVE COMPENSATION PROGRAM FOR THE KEY EXECUTIVES OF THE ORGANIZATION. THE BOARD MEETS AS NEEDED TO REVIEW THE COMPENSATION PROGRAM AND MAKE RECOMMENDATIONS FOR ANY CHANGES, AS APPROPRIATE. A PERFORMANCE EVALUATION IS CONDUCTED AND REVIEWED EACH YEAR AND IS INTENDED TO ENSURE THAT THE COMPENSATION PROGRAM FALLS WITHIN A REASONABLE RANGE OF COMPETITIVE PRACTICES FOR COMPARABLE POSITIONS AMONG SIMILARLY SITUATED ORGANIZATIONS. FOLLOWING THIS REVIEW, THE BOARD REVIEWS AND APPROVES, FOR SELECTED KEY EXECUTIVES, BASE SALARIES AND ANNUAL INCENTIVE OPPORTUNITY ADJUSTMENTS, AND OBJECTIVES AND GOALS UPCOMING YEAR'S ANNUAL INCENTIVE PLAN. THE BOARD REVIEWS AND RECOMMENDS TO THE BOARD SALARY APPROVAL AND INCENTIVE AWARDS FOR THE CEO/PRESIDENT AND SELECTED KEY SENIOR STAFF. FORM 990, PART VI, SECTION C, LINE 19 UPON REQUEST AND FORMS AVAILABLE THROUGH CHARITY NAVIGATOR WEBSITE AS WELL. FORM 990, PART IX, LINE 11G RESEARCH COLLABORATION EXPENSES: PROGRAM SERVICE EXPENSES 2,783,143. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,783,143. CONTRACTED SERVICES: PROGRAM SERVICE EXPENSES 3,730,994. MANAGEMENT AND GENERAL EXPENSES 132,754. FUNDRAISING EXPENSES 18,014. TOTAL EXPENSES 3,881,762. FORM 990, PART XI, LINE 9: CANCELLATION OF GRANT OBLIGATION 924,603. EARLY SIGNAL LLC 1 BROADWAY 14TH FLOOR CAMBRIDGE MA 02142 TO HOLD INTELLECTUAL PROPERTY MA 0 0 COHEN VETERANS BIOSCIENCE INC