2021-05-13T11:02:00-05:00 2020-12-31 131639826 EISNERAMPER LLP 130 NORTH 18TH STREET SUITE 3000 PHILADELPHIA PA 191032757 990 2020-01-01 460886344 TRANSCELERATE BIOPHARMA INC TRAN 4845391230 1001 CONSHOHOCKEN STATE RD NO 1-6 WEST CONSHOHOCKEN PA 19428 DALVIR GILL PHD CEO 4845391230 2021-05-11 1 DALVIR GILL PHD 999009999 HELEN M MARTIN P01330899 2158818800 2 AAL1 IAL1 2020 2022-09-23 18:48:47Z X DALVIR GILL PHD 1001 CONSHOHOCKEN STATE RD NO 1-655 WEST CONSHOHOCKEN PA 19428 31974894 0 X WWW.TRANSCELERATEBIOPHARMAINC.COM X 2012 DE IMPROVE THE HEALTH OF PEOPLE IN THE WORLD BY ENHANCING THE R&D OF INNOVATIVE THERAPIES.TRANSCELERATE BIOPHARMA INC. IS A NON-PROFIT ORGANIZATION DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES. THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 20 19 25 0 0 0 0 0 27593333 31908666 386012 66228 0 0 27979345 31974894 0 0 0 0 6651073 7623942 0 0 0 20048999 20484023 26700072 28107965 1279273 3866929 45613199 49374410 36755773 36650129 8857426 12724281 X TRANSCELERATE BIOPHARMA INC. IS DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES.THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES. TRANSCELERATE EVOLVED FROM CONVERSATIONS AT VARIOUS FORUMS FOR EXECUTIVE R&D LEADERSHIP TO DISCUSS CURRENT ISSUES FACING THE INDUSTRY, AND EXAMINE SOLUTIONS FOR ADDRESSING COMMON CHALLENGES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 0 0 20914117 31908666 OUTLINED BELOW ARE A FEW OF THE NUMEROURS YEAR-END ACHIEVEMENTS THROUGHOUT THE TRANSCELERATE PORTFOLIO.TRANSCELERATE BUILT AND LAUNCHED A COVID-19 MODULE IN DATACELERATE AVAILABLE TO MEMBER COMPANIES, AND QUALIFYING BIOPHARMACEUTICAL COMPANIES AND BIOMEDICAL RESEARCH AGENCIES TO SHARE PSEUDONYMIZED/ANONYMIZED PATIENT-LEVEL DATA, WITH APPROPRIATE LEGAL, TECHNICAL, AND PROCESS SAFEGUARDS TO PROTECT THE PRIVACY OF PATIENT DATA, FROM BOTH THE INVESTIGATIONAL PRODUCT AND CONTROL ARMS OF COVID-19-RELATED CLINICAL TRIALS MAY BE SHARED, ALONG WITH SUPPORTING STUDY-LEVEL DOCUMENTATION (E.G., STUDY PROTOCOL AND CRFS).COMMON TEMPLATES FOR NONCLINICAL STUDIES BEGAN THE DEVELOPMENT OF THE NONCLINICAL COMMON REPORT TEMPLATE (NCRT) WITH A VIRTUAL ROUNDTABLE OF KEY STAKEHOLDERS. THIS IS AN INITIATIVE OF BIOCELERATE LLC, A WHOLLY-OWNED SUBSIDIARY OF TRANSCELERATE WHICH IS TREATED AS A DISREGARDED ENTITY FOR TAX PURPOSES. DEVELOPED AND RELEASED VERSION 1.0 OF THE NCRT, A COMPANION TO THE NONCLINICAL COMMON PROTOCOL TEMPLATE, ALONG WITH THE SUPPORTING MATERIALS "APPROACHES TO IMPLEMENTATION IN YOUR ORGANIZATION AND "'WHY COMMON TEMPLATES?' INITIATIVE OVERVIEW." THE NCRT IS CURRENTLY AVAILABLE FOR VOLUNTARY ADOPTION. PRESENTED A POSTER AT THE SOCIETY OF TOXICOLOGY CONFERENCE IN MARCH ON NONCLINICAL PROTOCOL HARMONIZATION.BIOCELERATE'S SEND HARMONIZATION FOR CROSS-STUDY ANALYSIS PUBLISHED A MANUSCRIPT CO-AUTHORED WITH THE FDA UNDER A PUBLIC-PRIVATE PARTNERSHIP IN REGULATORY TOXICOLOGY AND PHARMACOLOGY. THE MANUSCRIPT, "SEND HARMONIZATION & CROSS-STUDY ANALYSIS: A PROPOSAL TO BETTER HARVEST THE VALUE FROM SEND DATA," HIGHLIGHTS THE POTENTIAL OF UTILIZING SEND DATASETS FOR CROSS-STUDY ANALYSIS AND THE CHALLENGES OF DOING SO CURRENTLY. ESTABLISHED A COLLABORATION WITH PHUSE TO FURTHER DEMONSTRATE THE VALUE OF LEVERAGING SEND DATASETS FOR CROSS-STUDY ANALYSIS. PRESENTED AT SOCIETY OF TOXICOLOGY CONFERENCE AND THE AMERICAN COLLEGE OF TOXICOLOGY ANNUAL MEETING, "USING SEND DATA SETS TO ENABLE LARGE-SCALE DATA ANALYTIC APPROACHES FOR PRECLINICAL TOXICOLOGY DATA." SUBMITTED PROPOSED HARMONIZATION RECOMMENDATIONS TO CDISC FOR CONSIDERATION IN THE NEXT VERSION OF THE SEND IG.TRANSCELERATE'S ECONSENT INITIATIVE UPDATED ITS GLOBAL LANDSCAPE ASSESSMENT MAP. IN TOTAL, 40 COUNTRIES HAVE ENABLED ECONSENT SUBMISSIONS, OF WHICH 31 COUNTRIES HAVE ACTIVELY FACILITATED THE PROCESS OF CONSENTING PATIENTS USING ECONSENT.THE CLINICAL RESEARCH AWARENESS INITIATIVE PUBLISHED A PAPER, "CLINICAL RESEARCH AWARENESS: A PROPOSED STUDY DESIGN TO ASSESS THE ROLE OF SHARED DECISION MAKING IN THE CONSIDERATION OF CLINICAL TRIAL PARTICIPATION." THE PATIENT TECHNOLOGY (PT) INITIATIVE RELEASED ITS REDESIGNED SOLUTIONS PAGE, COMPLETE WITH A TOOLKIT THAT HELPS USERS APPROACH IMPLEMENTATION OF PATIENT TECHNOLOGY EFFECTIVELY WITH LONG-TERM PLANNING AND SCALABILITY IN MIND. THE TEAM HAS ALSO RELEASED NEW TOOLS FOR THE PT JOURNEY, SUCH AS A PATIENT CONSIDERATIONS DOCUMENT, AND AN UPDATED REGULATORY LANDSCAPE TOOL.THE CLINICAL RESEARCH ACCESS AND INFORMATION EXCHANGE (CRAIE) INITIATIVE PUBLISHED "PATIENT PREFERENCES WHEN SEARCHING FOR CLINICAL TRIALS AND ADHERENCE OF STUDY RECORDS TO CLINICALTRIALS.GOV GUIDANCE IN KEY REGISTRY DATA FIELDS." THE INITIATIVE ALSO PUBLISHED AN INFOGRAPHIC, "WHAT PATIENTS WANT TO SEE IN CLINICAL TRIAL REGISTRIES." BASED ON A GLOBAL PATIENT SURVEY WITH 1,070 RESPONSES, IT DETAILS WHAT INFORMATION IS HELPFUL WHEN PATIENTS BEGIN THEIR SEARCH FOR CLINICAL TRIALS IN A REGISTRY AND WHAT INFORMATION PATIENTS FIND IMPORTANT. THE PATIENT EXPERIENCE INITIATIVE PUBLISHED TWO PAPERS, BOTH IN DIA'S THERAPEUTIC INNOVATION & REGULATORY SCIENCE (TIRS). THE FIRST, ENTITLED "AMPLIFYING THE VOICE OF THE PATIENT IN CLINICAL RESEARCH: DEVELOPMENT OF TOOLKITS FOR USE IN DESIGNING AND CONDUCTING PATIENT-CENTERED CLINICAL STUDIES," DISCUSSES HOW THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) AND THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE TOOLKIT (SPFQ) WERE DEVELOPED. THE OTHER, ENTITLED "EVALUATION OF THE CONTENT VALIDITY AND CROSS-CULTURAL VALIDITY OF THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ)," EVALUATES THE CONTENT AND CROSS-CULTURAL VALIDITY OF THE SPFQ IN INDICATIONS OTHER THAN ONCOLOGY AND NON-ENGLISH SPEAKING COUNTRIES. THE PATIENT EXPERIENCE INITIATIVE ALSO RELEASED THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT TRANSLATED INTO JAPANESE. IT ALSO LAUNCHED AN INFOGRAPHIC THAT DETAILS THE HOW AND WHY OF THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) AND STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ) TOOLKIT CREATION.THE MODERNIZING CLINICAL TRIAL CONDUCT INITIATIVE PUBLISHED A WHITEPAPER, "BEYOND COVID-19: MODERNIZING CLINICAL TRIAL CONDUCT." THE WHITEPAPER PROPOSES THE ONGOING UTILIZATION OF INNOVATIVE CLINICAL TRIAL CONTINUITY SOLUTIONS IMPLEMENTED DURING COVID-19 BY SPECIFICALLY CITING IMPLEMENTATION CHALLENGES, LESSONS LEARNED AND OPPORTUNITIES FOR THE CONTINUITY SOLUTIONS MOVING FORWARD. THE MODERNIZING CLINICAL TRIAL CONDUCT INITIATIVE ALSO DEVELOPED FIVE CONTINUITY SOLUTION CASE STUDIES AND PUBLISHED ITS WORKSHOP FINDINGS.TRANSCELERATE ESTABLISHED A REAL WORLD DATA (RWD) INITIATIVE. TRANSCELERATE'S GOAL WITH THIS NEW INITIATIVE IS TO COLLABORATE WITH GLOBAL REGULATORY AGENCIES TO DEVELOP A FRAMEWORK FOR RWD THAT DEFINES TOOLS, METHODOLOGIES, USE CASES AND APPROPRIATE LEVELS OF EVIDENCE TO SUPPORT REGULATORY DECISION MAKING.THE DIGITAL DATA FLOW (DDF) INITIATIVE SUCCESSFULLY LAUNCHED AND COMPLETED A VIRTUAL HACKATHON. THE CLINICAL CONTENT AND REUSE (CC&R) INITIATIVE RELEASED A NEW SOLUTION, THE "CLINICAL STUDY REPORT (CSR) CONSIDERATIONS FOR STUDIES DISRUPTED BY THE COVID-19 PANDEMIC." THIS DOCUMENT WAS CREATED BY CLINICAL SCIENTISTS, PHARMACOVIGILANCE EXPERTS, DATA SCIENTISTS, AND OTHER PROFESSIONALS TO IDENTIFY THE IMPORTANT TOPICS THAT CLINICAL RESEARCHERS AND RESEARCH SPONSORS MAY CONSIDER AS THEY ADAPT THEIR STUDIES AND CLINICAL STUDY REPORTS DUE TO DISRUPTIONS CAUSED BY COVID-19.CC&R PUBLISHED ITS EIGHTH ANNUAL COMMON PROTOCOL TEMPLATE SUITE RELEASE. IN PARTNERSHIP WITH THE CLINICAL RESEARCH ACCESS & INFORMATION EXCHANGE INITIATIVE, THE COMMON PROTOCOL TEMPLATE IS NOW INTEGRATED WITH THE CLINICAL TRIAL REGISTRATION TOOL TO ENABLE EVALUATION OF THE QUALITY AND PATIENT FRIENDLY TEXT OF THE BRIEF TITLE AND BRIEF SUMMARY DATA AND CAN NOW EXPORT 35+ DATA FIELDS FOR AUTOMATING QUALITY REGISTRY SUBMISSIONS TO CLINICALTRIALS.GOV.THE (HTD) SHARING (CONTROLS) INITIATIVE ANNOUNCED TWO NEW PUBLICATIONS. "ASSESSMENT OF PLACEBO RESPONSE IN OBJECTIVE AND SUBJECTIVE OUTCOME MEASURES IN RHEUMATOID ARTHRITIS CLINICAL TRIALS," FOUND THAT EVEN PATIENTS RANDOMIZED TO PLACEBO IN A RHEUMATOID ARTHRITIS TRIAL DEMONSTRATED IMPROVED OUTCOMES, A FINDING THAT MAY INFLUENCE FUTURE TRIAL DESIGN. THE OTHER, ENTITLED "HISTORICAL CONTROLS IN RANDOMIZED CLINICAL TRIALS: OPPORTUNITIES AND CHALLENGES," INCLUDES INSIGHTS INTO THE POTENTIAL FOR LARGE-SCALE HISTORICAL PLACEBO DATA TO BE USED BY DRUG DEVELOPERS AND PATIENTS TO GUIDE TRIAL DESIGN AND ANALYSIS. THE ESOURCE INITIATIVE HELPED SUPPORT THE DEVELOPMENT OF THE CLINICAL RESEARCH SPONSOR LABORATORY SEMANTICS IN FHIR IMPLEMENTATION GUIDE (IG). THE GUIDE, PUBLISHED BY HEALTH LEVEL SEVEN INTERNATIONAL (HL7) AND ADOPTED AS A STANDARD FOR TRIAL USE, PROVIDES DIRECTION FOR USING HL7'S FAST HEALTHCARE INTEROPERABILITY RESOURCES (FHIR).ESOURCE IS COLLABORATING WITH PROJECT VULCAN FHIR ACCELERATOR PROGRAM, A MULTI-STAKEHOLDER INITIATIVE THAT AIMS TO USE WIDELY ACCEPTED HEALTH CARE STANDARDS TO ENABLE DATA EXCHANGE TO STREAMLINE TRANSLATIONAL AND CLINICAL RESEARCH.THE RISK BASED MONITORING (RBM) INITIATIVE PUBLISHED A NEW REPORT, "MEASURING THE IMPACT OF RISK BASED MONITORING." THE DOCUMENT PROVIDES A DETAILED LOOK INTO THE PAST, PRESENT AND FUTURE EVOLUTION OF RBM METRICS, LESSONS LEARNED, AND BEST PRACTICES FOR DEFINING AND MEASURING RBM VALUE TO STAKEHOLDERS THROUGH METRICS AND FUTURE TRENDS. TRANSCELERATE EXPEDITED THE RELEASE OF ITS PROTOCOL DEVIATIONS (PD) TOOLKIT AND SOLUTIONS PAGE. THE TOOLKIT CONSISTS OF: A PROCESS GUIDE, WHICH OUTLINES A PROPOSED FRAMEWORK DESCRIBING FLEXIBLE PD MANAGEMENT APPROACHES, ELEMENTS FOR CONSIDERATION BASED UPON INTERPRETATION OF THE ICH E3 DEFINITION FOR IMPORTANT PD AND OTHER ASSOCIATED PD GUIDANCE; A PROCESS MAP OF THE PD MANAGEMENT PROCESS CONTAINING PROCESSES FOR BOTH IMPORTANT AND NON-IMPORTANT DEVIATIONS; A DECISION TREE TO GUIDE IN THE IDENTIFICATION AND CLASSIFICATION OF IMPORTANT AND NON-IMPORTANT PROTOCOL DEVIATIONS; AN ASSESSMENT TOOL TO ASSIST IN THE IDENTIFICATION AND DOCUMENTATION OF PROTOCOL-SPECIFIC "IMPORTANT" DEVIATIONS.THE QUALITY MANAGEMENT SYSTEM (QMS) INITIATIVE DEVELOPED AN INFOGRAPHIC BASED OFF OF FIVE CASE STUDIES, "EXPLORING THE VALUE IN IMPLEMENTING A CLINICAL QUALITY MANAGEMENT SYSTEM FRAMEWORK." 20914117 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 23 0 1 25 1 0 0 0 0 0 0 1 0 X 20 19 0 0 0 0 1 1 0 1 1 0 0 1 1 1 1 1 0 1 1 0 X ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 4845391235 1001 CONSHOHOCKEN STATE ROAD STE WEST CONSHOHOCKEN PA 19428 MICHELLE ROHRER CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 ROB MACKENZIE VICE CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 ROY BAYNES BOARD MEMBER 0.50 X 0 0 0 DIETMAR BERGER BOARD MEMBER (EFF 6/29/20) 0.50 X 0 0 0 CHRIS CORSICO BOARD MEMBER 0.50 X 0 0 0 NEIL GALLAGHER BOARD MEMBER (EFF 1/13/20) 0.50 X 0 0 0 MARTIN HOLST LANGE BOARD MEMBER 0.50 X 0 0 0 ELLIOTT LEVY BOARD MEMBER 0.50 X 0 0 0 IRIS LOEW-FRIEDRICH BOARD MEMBER 0.50 X 0 0 0 ROBERT METCALF BOARD MEMBER 0.50 X 0 0 0 DAVID NICHOLSON BOARD MEMBER (THRU 5/11/20) 0.50 X 0 0 0 JOHN OIDTMAN BOARD MEMBER 0.50 X 0 0 0 KATHRYN OWEN BOARD MEMBER 0.50 X 0 0 0 JOHN REED BOARD MEMBER (THRU 6/28/20) 0.50 X 0 0 0 STEFFEN ROELLINGER BOARD MEMBER 0.50 X 0 0 0 PETER RONCO BOARD MEMBER (EFF 3/26/20) 0.50 X 0 0 0 ROB SCOTT BOARD MEMBER (THRU 1/12/20) 0.50 X 0 0 0 MEHDI SHAHIDI BOARD MEMBER 0.50 X 0 0 0 BADHRI SRINIVASAN BOARD MEMBER 0.50 X 0 0 0 PAUL STOFFELS BOARD MEMBER (THRU 3/25/20) 0.50 X 0 0 0 ANN TAYLOR BOARD MEMBER 0.50 X 0 0 0 TAKUKO YAMADA-SAWADA BOARD MEMBER 0.50 X 0 0 0 BERNHARDT G ZEIHER BOARD MEMBER 0.50 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 40.00 X X 1830866 0 68226 ROBERT BAKER CORPORATE SECRETARY (EFF 6/29/20) 0.50 X 0 0 0 ULO PALM CORPORATE SECRETARY (THRU 6/28/20) 0.50 X 0 0 0 ANDREW LEE TREASURER 0.50 X 0 0 0 JANICE CHANG CHIEF OPERATING OFFICER 40.00 X 679746 0 42393 JENNIFER A BURGESS VP GLOBAL ENGAGEMENT AND COMM. 40.00 X 389933 0 43539 CARA L RINALDI EXEC DIRECTOR OF PORTFOLIO MGMT 40.00 X 300458 0 46939 JENEEN DONADEO SENIOR DIRECTOR OF PORTFOLIO MGMT 40.00 X 293119 0 33493 ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 40.00 X 298833 0 38704 PATRICE WRIGHT HEALTH AUTHORITY ENGAGEMENT DIRECTOR 40.00 X 217885 0 26135 4010840 0 299429 21 0 1 0 PA CONSULTING GROUP INC 10 BRESSENDEN PLACE LONDON UK CONSULTING SERVICES 3433964 ACCENTURE LLP 161 N CLARK STREET CHICAGO IL 60601 CONSULTING & IT SERVICES 3334935 KILPATRICK TOWNSEND 601 14TH STREET NW SUITE 900 WASHINGTON DC 20005 LEGAL SERVICES 2502746 COGNIZANT 211 QUALITY CIRCLE COLLEGE STATION TX 77845 IT SERVICES 2250000 FLUID EDGE 10 MYSTIC LANE MALVERN PA 19355 CONSULTING SERVICES 1284299 21 MEMBERSHIP DUES 900099 31908666 31908666 31908666 66228 66228 31974894 31908666 0 66228 X 2621231 2621231 4144359 2310605 1833754 133822 78309 55513 441889 271734 170155 282641 137354 145287 2455522 1981094 474428 132503 132503 12258711 11641530 617181 60643 44200 16443 162676 644 162032 4654052 4330473 323579 160793 160793 86409 26226 60183 21959 2948 19011 197306 197306 EXCESS COMPENSATION TAX 174482 174482 RECRUITING 84720 59000 25720 DUES 26958 25000 1958 BOOKS, SUBSCRIPTIONS, R 6155 5000 1155 1134 1134 28107965 20914117 7193848 0 13386925 18363859 2764069 1588161 27803793 29239481 146491 171062 14458 14458 0 0 1500074 11847 11847 45613199 49374410 4847107 5560963 31908666 31089166 36755773 36650129 X 8857426 12724281 8857426 12724281 45613199 49374410 3866929 -74 0 X 0 0 0 0 1 0 4202 4202 0 10256 10256 0 0 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 642543 0 1188323 0 0 0 11400 0 56826 0 1899092 0 0 0 JANICE CHANG CHIEF OPERATING OFFICER 460903 0 218843 0 0 0 11400 0 30993 0 722139 0 0 0 JENNIFER A BURGESS VP GLOBAL ENGAGEMENT AND COMM. 301237 0 88696 0 0 0 11418 0 32121 0 433472 0 0 0 CARA L RINALDI EXEC DIRECTOR OF PORTFOLIO MGMT 241191 0 59267 0 0 0 6105 0 40834 0 347397 0 0 0 ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 204785 0 94048 0 0 0 11400 0 27304 0 337537 0 0 0 JENEEN DONADEO SENIOR DIRECTOR OF PORTFOLIO MGMT 229845 0 63274 0 0 0 11400 0 22093 0 326612 0 0 0 PATRICE WRIGHT HEALTH AUTHORITY ENGAGEMENT DIRECTOR 204552 0 13333 0 0 0 8733 0 17402 0 244020 0 0 0 PART I, LINE 3 THE BOARD CHAIR, WITH INPUT FROM OTHER DIRECTORS OR A SUBCOMMITTEE OF THE BOARD, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE. FORM 990, PART III, LINE 4A THE INTERPRETATIONS OF PHARMACOVIGILANCE GUIDANCES & REGULATIONS (IGR-PV) AND THE INTERPRETATIONS OF CLINICAL GUIDANCES & REGULATIONS (IGR-CLINICAL) INITIATIVES LAUNCHED THEIR NEW SOLUTIONS PAGES. THE IGR CLINICAL'S QUALITY TOLERANCE LIMITS TEAM RELEASED SEVERAL SOLUTIONS: IN DIA TIRS, A PEER-REVIEWED PUBLICATION ENTITLED "QUALITY TOLERANCE LIMITS: FRAMEWORK FOR SUCCESSFUL IMPLEMENTATION IN CLINICAL DEVELOPMENT." A QTL INFOGRAPHIC, A SET OF FREQUENTLY ASKED QUESTIONS THAT ADDRESS SOME OF THE COMMON MISCONCEPTIONS ABOUT QTLS. A QTL PLAN TEMPLATE THAT WILL ALLOW A COMPANY TO DOCUMENT A QTL MONITORING APPROACH AT THE STUDY LEVEL. IGR CLINICAL'S GENERAL DATA PRIVACY REGULATION (GDPR) DATA REUSE TOPIC ALSO RELEASED ITS SUITE OF SOLUTIONS. THE CORNERSTONE OF THIS SET IS "A PRIVACY FRAMEWORK FOR CLINICAL DATA REUSE: SECONDARY DATA USE IN THE PHARMACEUTICAL INDUSTRY." AN OVERVIEW VIDEO AND ADDITIONAL TOOLS FROM THE FRAMEWORK, INCLUDING A GLOSSARY, STEP-BY-STEP BEST PRACTICE MODEL, DEFINITION OF PRIMARY AND SECONDARY USE OF CLINICAL DATA, AND A REUSE ASSESSMENT FORM. THE INTELLIGENT AUTOMATION OPPORTUNITIES IN PHARMACOVIGILANCE (IAO) INITIATIVE HAS LAUNCHED ITS SOLUTIONS PAGE. THE IMPETUS OF THIS LAUNCH IS THE INTERACTIVE ICSR AND AUTOMATION TECHNOLOGIES TOOL (IATT), WHICH IS AN INTERACTIVE PROCESS FLOW DEPICTING EACH STEP WITHIN THE INDIVIDUAL CASE SAFETY REPORT (ICSR) PROCESS. A REFRESH LATER IN 2020 SERVES AS A PLATFORM TO REPORT TECHNOLOGY IMPLEMENTATION DATA WITHIN THE SAME ICSR PROCESS MAP STRUCTURE AS THE ORIGINAL TOOL. ACCOMPANYING THIS REFRESH IS A VIDEO DEMONSTRATING HOW THIS TOOL CAN BE PROPERLY USED AND ADOPTED. ADDITIONALLY, IAO RELEASED ONE OF ITS FOUNDATIONAL MANUSCRIPTS IN PHARMACEUTICAL MEDICINE. THE PAPER, "AUTOMATION OPPORTUNITIES IN PHARMACOVIGILANCE: AN INDUSTRY SURVEY," OFFERS A SYSTEMATIC REVIEW FRAMEWORK FOR AUTOMATION OF THE ICSR PROCESS. IAO AUTHORED AN ADDITIONAL PAPER, "UTILIZING ADVANCED TECHNOLOGIES TO AUGMENT PHARMACOVIGILANCE SYSTEMS: CHALLENGES AND OPPORTUNITIES." THE IAO INITIATIVE ADDED THE 2020 TECHNOLOGY MATRIX TO ITS SOLUTIONS PAGE. ADDITIONALLY, THE TEAM HAS ADDED A CASE FOR ADOPTION RESOURCE THAT WILL HELP COMPANIES BETTER UNDERSTAND AND UTILIZE TRANSCELERATE'S IAO SOLUTIONS. THE INTERPRETATIONS OF GUIDANCE & REGULATIONS IN PHARMACOVIGILANCE (IGR-PV) INITIATIVE HAS COLLABORATED ON TWO NEW PAPERS: IN THE FIRST PAPER, "INDUSTRY EXPERIENCE AND PERSPECTIVE ON CLINICAL TRIAL SAFETY REPORTING TO THE FDA." THE SECOND PAPER, "THE EVOLVING REMIT OF THE REFERENCE SAFETY INFORMATION: OBSERVATIONS ON IMPLEMENTATION OF THE 2017 CLINICAL TRIALS FACILITATION GROUP (CTFG) QUESTION & ANSWER DOCUMENT" FOCUSES ON THE 2017 CTFG Q&A ON REFERENCE SAFETY INFORMATION. IGR PV'S PRESENTATION OF SAFETY RISKS THROUGHOUT THE PRODUCT LIFECYCLE (PORTL) TOPIC TEAM COMPLETED ITS 2020 SOLUTIONS. "A FRAMEWORK ON THE SAFETY RISKS THROUGHOUT THE PRODUCT LIFECYCLE" PROVIDES AN OUTLINE OF REGULATORY REQUIREMENTS AND CONSIDERATIONS FOR PRESENTING RISKS WITHIN KEY SAFETY-RELATED REGULATORY DOCUMENTS REQUIRED AT THE VARIOUS PRODUCT LIFECYCLE STAGES. A VIDEO GIVES AN OVERVIEW OF THE FRAMEWORK. TRANSCELERATE ESTABLISHED A NEW INITIATIVE ENTITLED PHARMACOVIGILANCE AGREEMENTS OPTIMIZATION (PVAO). THE ADVANCING SAFETY ANALYTICS (ASA) INITIATIVE LAUNCHED ITS ASSETS PAGE, FEATURING THE TEAM'S FIRST PUBLISHED PAPER, "INVESTIGATING OVERLAP IN SIGNALS FROM EVDAS, FAERS, AND VIGIBASE." IT ALSO PUBLISHED AN INFOGRAPHIC THAT ILLUSTRATES THE RESULTS OF ITS DRUG SAFETY MANUSCRIPT THAT INDICATES, FOR THE MAJORITY OF DRUGS, THAT THERE IS NO SIGNIFICANT DIFFERENCE BETWEEN THE NUMBER AND TYPES OF SAFETY SIGNALS THAT ARISE FROM THE THREE MAIN DATA SOURCES. THE ASA INITIATIVE PUBLISHED A PAPER, "SIGNAL MANAGEMENT: CURRENT LANDSCAPE AND CONSIDERATIONS FOR BEST PRACTICES." THIS PAPER REVIEWS THE CURRENT LANDSCAPE OF SIGNAL MANAGEMENT AND PROPOSES A SIMPLIFIED, END-TO-END FRAMEWORK WHILE HIGHLIGHTING SOME BEST PRACTICES. BAYER BECAME A MEMBER COMPANY IN EARLY 2020. FORM 990, PART VI, SECTION A, LINE 6 THE MEMBERS OF THE CORPORATION CONSIST OF SUCH FIRMS AND CORPORATIONS THAT ARE APPROVED FOR MEMBERSHIP FROM TIME TO TIME BY THE BOARD OF DIRECTORS OR ITS DESIGNEES IN ACCORDANCE WITH THE POLICIES AND PROCEDURES OF THE CORPORATION. THE CORPORATION HAS THE FOLLOWING CATEGORIES OF MEMBERS: A. TIER I MEMBERS - TO BE ELIGIBLE FOR TIER I MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT IN EXCESS OF $2.5 BILLION. ELIGIBILITY FOR TIER I MEMBERSHIP IS ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. THE INITIAL TIER I MEMBERS ARE FURTHER DEFINED AS THE "CHARTER MEMBERS." B. TIER II MEMBERS - TO BE ELIGIBLE FOR TIER II MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $2.5 BILLION BUT MORE THAN $100 MILLION. ELIGIBILITY FOR TIER II MEMBERSHIP WILL BE ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. C. ASSOCIATE MEMBERS - TO BE ELIGIBLE FOR ASSOCIATE MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $100 MILLION. FORM 990, PART VI, SECTION A, LINE 7A THE BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY-TWO (22) DIRECTORS; PROVIDED THAT: (I) TEN (10) SEATS ARE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE CHARTER MEMBERS; (II) UP TO FOUR (4) ADDITIONAL SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE NOT CHARTER MEMBERS; (III) UP TO SIX (6) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER II MEMBERS; (IV) ONE (1) SEAT SHALL BE FILLED BY A DIRECTOR WHO IS A REPRESENTATIVE OF THE ASSOCIATE MEMBERS; AND (V) ONE (1) SEAT SHALL BE FILLED BY THE CHIEF EXECUTIVE OFFICER OF THE CORPORATION. THE CORPORATION'S BYLAWS STATE THAT DIRECTORS SHALL BE ELECTED OR APPOINTED, AS APPLICABLE, ANNUALLY AT THE ANNUAL MEETING OF MEMBERS AND SHALL SERVE UNTIL THE FOLLOWING ANNUAL MEETING OF MEMBERS AND UNTIL THEIR SUCCESSORS ARE ELECTED OR APPOINTED, AS APPLICABLE, AND QUALIFIED. EACH CHARTER MEMBER SHALL HAVE THE RIGHT TO APPOINT A REPRESENTATIVE OF THE CHARTER MEMBER TO SERVE AS A CHARTER MEMBER DIRECTOR. TIER I AT-LARGE DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER I MEMBERS, WHICH INCLUDE THE CHARTER MEMBERS. TIER II DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER II MEMBERS. ANY ASSOCIATE MEMBER DIRECTOR SHALL BE ELECTED BY A PLURALITY VOTE OF THE ASSOCIATE MEMBERS. THE CEO DIRECTOR SHALL SERVE EX-OFFICIO, FOR SO LONG AS HE OR SHE SHALL HOLD THE OFFICE OF CHIEF EXECUTIVE OFFICER. TRANSCELERATE DOES NOT PRESENTLY HAVE ANY ASSOICATE MEMBERS THEREFORE, THE ASSOICATE MEMBER BOARD SEAT IS CURRENTLY VACANT. EACH TIER I MEMBER SHALL BE ENTITLED TO THREE (3) VOTES AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER 1 MEMBERS ARE ENTITLED TO VOTE. EACH TIER II MEMBER SHALL BE ENTITLED TO ONE (1) VOTE AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER II MEMBERS ARE ENTITLED TO VOTE. ASSOCIATE MEMBERS SHALL BE ENTITLED TO NOTICE OF AND TO ATTEND MEETINGS OF THE MEMBERS BUT SHALL NOT BE ENTITLED TO VOTE AT SUCH MEETINGS, PROVIDED HOWEVER, ASSOCIATE MEMBERS SHALL HAVE THE RIGHT TO CAST ONE (1) VOTE EACH WITH RESPECT TO THE ELECTION OF THE NOMINEE TO FILL THE ASSOCIATE MEMBER BOARD POSITION. NOTWITHSTANDING THE ABOVE, IN ORDER TO BE ELIGIBLE TO VOTE, A MEMBER MUST BE IN GOOD STANDING AND ITS DUES AND ASSESSMENTS PAID IN FULL. FORM 990, PART VI, SECTION B, LINE 11B THE FINANCE COMMITTEE AND MANAGEMENT REVIEW AND APPROVE THE FORM 990. THE FORM IS THEN DISTRIBUTED TO ALL MEMBERS OF THE BOARD FOR THEIR REVIEW BEFORE FILING WITH THE INTERNAL REVENUE SERVICE. FORM 990, PART VI, SECTION B, LINE 12C EACH DIRECTOR AND OFFICER OF THE CORPORATION IS REQUIRED TO ANNUALLY ACKNOWLEDGE THE CONFLICT OF INTEREST POLICY, AFFIRMING THAT SUCH PERSON HAS RECEIVED, READ AND UNDERSTANDS, AND AGREED TO COMPLY WITH THE CONFLICT OF INTEREST POLICY. FORM 990, PART VI, SECTION B, LINE 15 THE BOARD CHAIR, WITH INPUT FROM OTHER DIRECTORS OR A SUBCOMMITTEE OF THE BOARD, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE. THE CEO APPROVES THE COMPENSATION FOR THE CHIEF OPERATING OFFICER, AND ALL OTHER EMPLOYEES. FORM 990, PART VI, SECTION C, LINE 19 THE ORGANIZATION'S GOVERNING DOCUMENTS, FINANCIAL STATEMENTS, AND CONFLICT OF INTEREST POLICY AND OTHER CORPORATE POLICIES ARE AVAILABLE UPON REQUEST. FORM 990, PART IX, LINE 11G PROJECT MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 8,892,797. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 8,892,797. EXTERNAL CONTRACTOR SUPPORT: PROGRAM SERVICE EXPENSES 2,406,397. MANAGEMENT AND GENERAL EXPENSES 1,862. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,408,259. COMMUNICATIONS FEES: PROGRAM SERVICE EXPENSES 342,336. MANAGEMENT AND GENERAL EXPENSES 615,319. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 957,655. BIOCELERATE LLC 1001 CONSHOHOCKEN STATE ROAD STE 1- WEST CONSHOHOCKEN PA 19428 475492971 TO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH. DE 1416666 2404737 TRANSCELERATE BIOPHARMA INC