Transcelerate Biopharma Inc

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.

IN 2022, TRANSCELERATE DELIVERED THE FOLLOWING ACCOMPLISHMENTS:THE DIGITAL DATA FLOW (DDF) INITIATIVE, COLLABORATED WITH MULTIPLE INDUSTRY PARTNERS, TO RELEASE FOUNDATIONAL STANDARDS THROUGH THE CLINICAL DATA STANDARDS CONSORTIUM AND A MINIMUM VIABLE PRODUCT (MVP) FOR A STUDY DEFINITIONS REPOSITORY (SDR) REFERENCE IMPLEMENTATION, DESIGNED TO ALLOW FOR THE FLOW OF DIGITAL PROTOCOL DATA ACROSS DISPARATE SYSTEMS. TO FURTHER SUPPORT THIS LAUNCH, THE DDF TEAM HOSTED A MONTH-LONG VIRTUAL CONNECTATHON WHERE ORGANIZATIONS WERE ABLE TO DEMONSTRATE CONNECTIVITY OF THEIR SOLUTIONS TO THE SDR, AND SHOWCASE INNOVATIVE USE CASES. TRANSCELERATE'S DIVERSITY OF PARTICIPANTS IN CLINICAL TRIALS INITIATIVE RELEASED A REFERENCE LIST OF KEY SOLUTIONS TO SUPPORT DIVERSIFYING PATIENT POPULATIONS IN CLINICAL TRIALS: A REFERENCE TABLE AND VISUAL LANDSCAPE OF AVAILABLE RESOURCES; A U.S. REGULATORY LANDSCAPE: DIVERSITY IN CLINICAL TRIALS DESIGNED TO HELP IDENTIFY KEY U.S. LEGISLATION AND U.S. FDA POLICY, REGULATION, AND GUIDANCE, AS WELL AS REGULATORY PRECEDENT TO CONSIDER WHEN WORKING TO UNDERSTAND AND IMPROVE THE DIVERSITY AND INCLUSION (D&I) OF ADULT PATIENTS IN CLINICAL TRIALS, FOCUSING ON THE INCLUSION OF RACIAL AND ETHNIC MINORITIES; A SPONSOR TOOLKIT PORTFOLIO AND PROGRAM-LEVEL CONSIDERATIONS FOR DIVERSITY, EQUITY AND INCLUSION OF PARTICIPANTS IN CLINICAL TRIALS (DEICT); THE DIVERSITY COMMUNITY-BASED SITE ENGAGEMENT AND CAPACITY BUILDING SOLUTION PROVIDES AN AGGREGATED COLLECTION OF INSIGHTS AND PERSPECTIVES FROM THE ATTENDING ORGANIZATIONS OF A JUNE 2022 ROUNDTABLE EVENT; THE SPONSOR TOOLKIT SITE ENGAGEMENT AND CAPACITY BUILDING CONSIDERATIONS FOR DIVERSITY, EQUITY AND INCLUSION OF PARTICIPANTS IN CLINICAL TRIALS (DEICT) SOLUTION COMPRISES A SET OF MITIGATION CONSIDERATIONS DESIGNED TO SUPPORT EFFORTS TO SUSTAINABLY PARTNER WITH SITES TO ENABLE THE ENROLLMENT AND RETENTION OF UNDERREPRESENTED PATIENT POPULATIONS IN CLINICAL TRIALS. THE MODERNIZING CLINICAL TRIAL CONDUCT (MCTC) INITIATIVE RELEASED THE CLINICAL TRIALS IN 2031 AND BEYOND REPORT, WHICH CAN HELP THE ECOSYSTEM UNDERSTAND SOME OF THE DIVERSE DRIVERS THAT INFLUENCE THEFUTURE OF CLINICAL TRIALS. THE MCTC INITIATIVE ALSO RELEASED A PARTICIPANT DATA RETURN RESOURCE PACK, WHICH PROVIDES ACCESS TO A CONSOLIDATED SET OF RESOURCES FROM WITHIN THE CLINICAL RESEARCH ECOSYSTEM THAT CAN ASSIST WITH RETURNING INDIVIDUAL DATA GLOBALLY.THE PATIENT EXPERIENCE (PE) INITIATIVE RELEASED A STREAMLINED VERSION OF THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) RESOURCE GUIDE THAT PROVIDES SAMPLE QUESTIONS FOR CONSIDERATION DURING AN ENGAGEMENT WITH PATIENTS AND CAREGIVERS. AN UPDATED VERSION OF THE P-PET USER GUIDE PROVIDES EXAMPLE CASE STUDIES AND WAYS THAT HELP SUPPORT SPONSORS UNDERSTAND HOW TO IMPLEMENT THE P-PET WITHIN THEIR CLINICAL STUDIES. ACCOMPANYING THESE TWO RELEASES IS A QUICK START VIDEO WITH JAPANESE SUBTITLES TO SUPPORT THE ADOPTION OF THE P-PET TOOLKIT. THE TEAM ALSO RELEASED VERSION 2.0 OF THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ) SOCIALIZATION PRESENTATION AND THE SPFQ IMPLEMENTATION USER GUIDE. A SPFQ QUESTION BANK ADDENDUM PROVIDES NEW AND REPLACEMENT QUESTIONS TO BE UTILIZED IN CONJUNCTION WITH THE SPFQ.SITE QUALIFICATION & TRAINING (SQT) GOOD CLINICAL PRACTICE MUTUAL RECOGNITION TRAINING DATABASE NOW HAS OVER 1,900 SELF-ATTESTED TRAINING COURSES BY OVER 600 UNIQUE TRAINING PROVIDERS. THE SOCIETY FOR CLINICAL RESEARCH SITES (SCRS) LED A COLLABORATIVE GOVERNANCE EXERCISE USING SITE FEEDBACK TO SUGGEST IMPROVEMENTS FOR TRANSCELERATE'S DELEGATION OF RESPONSIBILITIES LOG, GUIDANCE, AND SUMMARY OF CHANGES TO INCORPORATE SITES' TOP CONCERNS. VERSION 3 OF THIS LOG, ALONG WITH A SUMMARY OF CHANGES DOCUMENT, WAS RELEASED ON SCRS'S WEBSITE IN OCTOBER OF 2022; UPDATED AND RELEASED VERSION 4.0 FINANCIAL DISCLOSURE FORM (FIDS) FORM FOR USABILITY AND TECHNICAL IMPROVEMENTS.THE INTERPRETATION OF CLINICAL GUIDANCES & REGULATIONS (IGR) INITIATIVE FOCUSED ON CREATING SOLUTIONS TO HELP STAKEHOLDERS NAVIGATE THE NEW REVISIONS OF ICH E8 (2022) AND E6 (2023).THE MODERNIZATION OF STATISTICAL ANALYTICS (MOA) INITIATIVE RELEASED A CASE STUDY VIDEO LIBRARY. THESE SIX NARRATED CASE STUDY VIDEO PRESENTATIONS WILL HELP VIEWERS UNDERSTAND THE PRACTICAL USE OF THE MSA FRAMEWORK, AS THEY EXPLORE USING NON-TRADITIONAL ANALYTICAL SOFTWARE (INCLUDING OPEN-SOURCE SOFTWARE) IN HEALTH AUTHORITY REGULATORY SUBMISSIONS.THE CLINICAL CONTENT & REUSE INITIATIVE PUBLISHED THE CC&R PROCEDURES LIBRARY WHITE PAPER "EXAMINING POSSIBILITIES FOR A CONSISTENT PROCEDURES LIBRARY TO MODERNIZE CLINICAL TRIALS: A TRANSCELERATE POINT OF VIEW." CC&R RELEASED THE 2022 CLINICAL TEMPLATE SUITE (CTS) CONTENT ADDENDUM, PROVIDING A "LINE OF SIGHT" TO PLANNED CONTENT UPDATES THAT WILL ULTIMATELY BE CONSIDERED FOR FORMAL INCLUSION IN THE 2023 CTS RELEASE. CC&R UPDATED THE JAPANESE VERSION OF THE BASIC WORD EDITION CORE TEMPLATE AND THE PATIENT LIBRARY. ONE OF TRANSCELERATE'S NEWER INITIATIVES, REALWORLD DATA, LAUNCHED ITS FIRST DELIVERABLE, "PREPARING TO ENGAGE WITH HEALTH AUTHORITIES ON REAL WORLD EVIDENCE FOR MEDICINES: A TRANSCELERATE PERSPECTIVE," ALONG WITH AN ACCOMPANYING INFOGRAPHIC, ON ITS NEW WEBSITE.TRANSCELERATE'S CLINICAL DATA SHARING (CDS) TEAM UPGRADED THE HISTORICAL TRIAL DATA SHARING MODULE IN DATACELERATE. THE COMPARATOR NETWORK INITIATIVE COMPLETED A MAJOR PLATFORM UPGRADE TO HELP TO FACILITATE THE PURCHASE OF COMPARATOR PRODUCTS IN BOTH COMMERCIAL AND NON-COMMERCIAL PRESENTATIONS FOR USE IN CLINICAL TRIALS, AS WELL AS A WEB-BASED ORDERING SYSTEM THAT PARTICIPATING TRANSCELERATE MEMBERS CAN LEVERAGE TO EXECUTE COMPARATOR PRODUCT TRANSACTIONS AND EXCHANGE CRITICAL PRODUCT.THE PRIVACY METHODOLOGY FOR DATA SHARING INITIATIVE RELEASED ITS FIRST SOLUTION, THE EDUCATIONAL TOOLKIT FOR CLINICAL DATA REUSE.THE INTELLIGENT AUTOMATION OPPORTUNITIES IN PHARMACOVIGILANCE (IAO) INITIATIVE PUBLISHED TWO SEPARATE PAPERS IN THE PEER REVIEWED JOURNAL DRUG SAFETY. "INDUSTRY PERSPECTIVE ON ARTIFICIAL INTELLIGENCE MACHINE LEARNING IN PHARMACOVIGILANCE". THE TEAM CREATED A VIDEO PROVIDING AN IN-DEPTH OVERVIEW OF THE PAPER. "BLACK SWAN EVENTS AND INTELLIGENT AUTOMATION FOR ROUTINE SAFETY SURVEILLANCE" OUTLINES SEVERAL STRATEGIES TO ADDRESS DATA ON POTENTIAL BLACK SWAN EVENTS DURING DATA INGESTION. THE IAO TEAM UPDATED THE INTERACTIVE INDIVIDUAL CASE STUDY REPORT (ICSR) AND AUTOMATION TECHNOLOGIES TOOL (IATT) AND ACCOMPANYING TECHNOLOGY MATRIX. THE INTERPRETATION OF PHARMACOVIGILANCE GUIDANCES & REGULATIONS (IGR PV) INITIATIVE RELEASED THE PREGNANCY & BREASTFEEDING REGULATORY LANDSCAPE ASSESSMENT OUTPUTS, THE FIRST SOLUTION ADDRESSING THIS NEW TOPIC FOR TRANSCELERATE.THE PHARMACOVIGILANCE AGREEMENTS OPTIMIZATION (PVAO) INITIATIVE RELEASED VERSION 2.0 OF ITS PHARMACOVIGILANCE AGREEMENTS GLOSSARY. THE PVAO TEAM LAUNCHED A TABLE OF CONTENTS (TOC) THAT OFFERS A FRAMEWORK OF MODULES, HEADINGS, POINTS TO CONSIDER, AND REGULATORY REFERENCES TO MAKE NEGOTIATING AND COMPLYING WITH PVAS MORE EFFICIENT. IDENTIFIED AND CREATED TRANSCELERATE'S NEWEST INITIATIVE: RAPID SIGNAL ASSESSMENT USING REAL WORLD DATA (RSA-RWD). BIOCELERATE, A LIMITED LIABILITY COMPANY CLASSIFIED AS A DISREGARDED ENTITY IN WHICH TRANSCELERATE IS THE SOLE MEMBER, RELEASED VERSION 1.1 OF THE NONCLINICAL COMMON PROTOCOL AND COMMON REPORT TEMPLATES, WHICH FOCUSED ON INCREASING TEMPLATE USABILITY AND EASE OF IMPLEMENTATION TO HELP CROS, SPONSORS AND REGULATORS THROUGH CONSISTENCY AND EFFICIENCIES IN THE PROTOCOL AND REPORT GENERATION PROCESS. A PUBLIC PRIVATE PARTNERSHIP BETWEEN BIOCELERATE AND THE U.S. FOOD & DRUG ADMINISTRATION'S CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), IN CONJUNCTION WITH PHUSE, PUBLISHED THE OPEN-SOURCE R PACKAGE, SENDIGR, WHICH CAN ENABLE USERS TO SEARCH SEND STRUCTURED DATASETS TO SUPPORT CROSS-STUDY ANALYSIS USE CASES. THIS DATABASE SEARCH FUNCTIONALITY IS AN IMPORTANT TOOL IN APPLYING DATA ANALYTIC APPROACHES TO CROSS-STUDY PRECLINICAL TOXICOLOGY DATA.BIOCELERATE'S TOXICOLOGY & BACKGROUND CONTROL DATA INITIATIVE EXPANDED THE SCOPE OF EFFECTIVE DATA SHARING AGREEMENTS ACROSS PARTICIPATING COMPANIES TO SUPPORT SHARING OF STUDIES WITHIN THE DATACELERATE TECHNOLOGY PLATFORM. THIS INCLUDED EXPANDED OPTIONS ESSENTIAL FOR CURRENT ANALYTICAL EFFORTS AND FOUNDATIONAL FOR ENABLING TRANSLATIONAL SAFETY. WITH INCREASED DATA, THE TOXICOLOGY DATA SHARING (TDS) MODULE WILL ENABLE COMPANIES TO PERFORM BETTER TRANSLATION OF PRECLINICAL FINDINGS AND CLOSE CRITICAL GAPS THAT EXIST IN UNDERSTANDING THE RELATIONSHIP BETWEEN PATIENT RESPONSE AND PRECLINICAL TOXICOLOGY FINDINGS.