TRANSCELERATE BIOPHARMA INC
1001 CONSHOHOCKEN STATE RD NO 1-655, WEST CONSHOHOCKEN, PA 19428 www.transceleratebiopharmainc.com

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Organizations Filed Purposes: 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.

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."

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