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.

OUTLINED BELOW ARE A FEW OF THE NUMEROUS YEAR-END ACHIEVEMENTS THROUGHOUT THE TRANSCELERATE PORTFOLIO.THE DIGITAL DATA FLOW INITIATIVE COMMENCED DEVELOPMENT ON A REFERENCE IMPLEMENTATION OF A STUDY DEFINITIONS REPOSITORY. THE STUDY DEFINITIONS REPOSITORY IS A NOVEL CENTRAL COMPONENT AIMED AT FACILITATING THE EXCHANGE OF STRUCTURED STUDY DEFINITIONS ACROSS CLINICAL SYSTEMS USING TECHNICAL AND DATA STANDARDS.THE STRATEGIC PRIORITY, IMPROVE THE PATIENT EXPERIENCE, LAUNCHED THE DIVERSITY OF PARTICIPANTS IN CLINICAL TRIALS INITIATIVE TO HELP EQUIP SPONSORS AND ECOSYSTEM STAKEHOLDERS WITH THE ACTIONABLE TOOLS AND RESOURCES NEEDED TO IMPROVE OUTCOMES FOR DIVERSIFICATION OF PARTICIPANTS IN CLINICAL TRIALS. AS PART OF THE FIRST PHASE OF THE INITIATIVE, THE FOLLOWING EFFORTS ARE UNDERWAY: DEVELOPING A CLINICAL RESEARCH DIVERSITY COLLABORATION HUB, RACE AND ETHNICITY ENROLLMENT DATA BENCHMARKING, AND BEST PRACTICES FOR SPONSORS AND CLINICAL TRIAL SITES. THIS INITIATIVE HOSTED TWO DIVERSITY ROUNDTABLE EVENTS. TRANSCELERATE'S MODERNIZING CLINICAL TRIAL CONDUCT (MCTC) INITIATIVE, IN COLLABORATION WITH THE RISK BASED MONITORING (RBM) INITIATIVE, RELEASED A PUBLICLY-AVAILABLE REPORT SHARING VOLUNTARY SURVEY DATA RELATED TO RBM ACTIVITIES PRE-COVID-19: "RESULTS OF RBM SDV/ SDR SURVEY: 2020 PRE-COVID-19 PANDEMIC PRACTICES." THIS REPORT SERVES AS THE FINAL DELIVERABLE OF THE RECENTLY COMPLETED RBM INITIATIVE. THIS INITIATIVE ALSO RELEASED AN OPERATIONAL COMPLEXITY ASSESSMENT TOOL WHICH IS AN INTERACTIVE TOOL THAT ASSESSES THE COMPLEXITY OR LACK OF COMPLEXITY OF IMPLEMENTING SELECTED MODERN SOLUTIONS IN A CLINICAL TRIAL.THE PATIENT EXPERIENCE INITIATIVE UPDATED TWO KEY SOLUTIONS, THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) USER GUIDE AND THE P-PET RESOURCE GUIDE, TO INCLUDE NEW CONSIDERATIONS RELATED TO CAREGIVERS IN CLINICAL TRIALS AS WELL AS BEST PRACTICES FOR ENGAGING PATIENTS AND CAREGIVERS IN A VIRTUAL ENVIRONMENT. THE INITIATIVE ALSO RELEASED JAPANESE TRANSLATIONS OF THE P-PET, USER GUIDE VERSION 1.5, AND RESOURCE GUIDE VERSION 1.5, AND MORE THAN 15 DIFFERENT TRANSLATIONS OF THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ).THE PATIENT TECHNOLOGY INITIATIVE UPDATED ITS PATIENTS CONSIDERATIONS GUIDE AND PATIENT TECHNOLOGY SITE FEEDBACK QUESTIONNAIRE (PTSFQ) TO INCLUDE CONSIDERATIONS AROUND DECENTRALIZED TRIALS AND VIRTUAL ENVIRONMENTS AND PUBLISHED ITS NOVEL DIGITAL ENDPOINTS PAPER "DEVELOPING A NOVEL MEASUREMENT OF SLEEP IN RHEUMATOID ARTHRITIS: STUDY PROPOSAL FOR APPROACH AND CONSIDERATIONS."TRANSCELERATE'S STRATEGIC PRIORITY, IMPROVE THE SITE EXPERIENCE, UPDATED AND RELEASED A NEW GOOD CLINICAL PRACTICE (GCP) MUTUAL RECOGNITION WEBSITE TO IMPROVE USER EXPERIENCE AS PART OF THE SITE QUALIFICATION & TRAINING (SQT) INITIATIVE. AS PART OF THIS UPGRADE, THERE IS NOW INTEGRATION WITH THE SHARED INVESTIGATOR PLATFORM (SIP). SQT ALSO CREATED AN INFORMATIONAL VIDEO ON ITS GCP MUTUAL RECOGNITION PROGRAM.THE MODERNIZATION OF STATISTICAL ANALYTICS INITIATIVE LAUNCHED ITS FOUNDATIONAL FRAMEWORK TO EXPLORE A PRODUCT-AGNOSTIC APPROACH TO BUILD TRUSTWORTHINESS OF USING MODERN STATISTICAL SOFTWARE TOOLS FOR REGULATORY DECISION-MAKING. THE FRAMEWORK INCLUDES PRINCIPLES THAT CAN BE USED BY REGULATORS AND OTHERS ACROSS THE INDUSTRY TO ESTABLISH A HIGH LEVEL OF ACCURACY, TRACEABILITY, AND REPRODUCIBILITY WITH REGARD TO REGULATORY SUBMISSIONS. ACCOMPANYING THIS FRAMEWORK IS AN INFOGRAPHIC AND CASE FOR ADOPTION.THE PROTOCOL DEVIATIONS INITIATIVE PUBLISHED A MANUSCRIPT ENTITLED, "PROTOCOL DEVIATIONS: A HOLISTIC APPROACH FROM DEFINING TO REPORTING." IN ADDITION TO THE PAPER, THE TEAM MADE UPDATES TO ITS PROTOCOL DEVIATION DECISION TREE AND PROTOCOL DEVIATION PROCESS GUIDE.THE DATA MONITORING COMMITTEE (DMC) INITIATIVE SUCCESSFULLY TRANSITIONED ITS EXISTING MATERIALS TO THE SOCIETY FOR CLINICAL TRIALS (SCT). USING TRANSCELERATE-DEVELOPED SOLUTIONS INCLUDING A DMC REGISTRY PROTOTYPE EBOOK, PROOF OF CONCEPT VIDEO, AND DMC APPRENTICESHIP MODEL OVERVIEW, SCT LAUNCHED ITS OWN DMC INITIATIVE BRINGING THE CONCEPT TO LIFE. THE SCT DMC INITIATIVE OFFERS ITS MEMBERS TRAINING, A REGISTRY FOR INDIVIDUALS WHO ARE INTERESTED IN SERVING AS DMC MEMBERS, AND MENTORING OPPORTUNITIES. THIS INITIATIVE IS NOW COMPLETE WITH NO NEW DELIVERABLES OR UPDATES PLANNED.THE INTERPRETATION OF CLINICAL GUIDANCES AND REGULATIONS INITIATIVE PUBLISHED ITS FRAMEWORK PAPER, "HISTORICAL BENCHMARKS FOR QUALITY TOLERANCE LIMITS PARAMETERS IN CLINICAL TRIALS."THE CLINICAL CONTENT & REUSE (CC&R) INITIATIVE RELEASED JAPANESE TRANSLATIONS OF THE COMMON PROTOCOL TEMPLATE (CPT) AND PATIENT LIBRARY. CC&R ALSO RELEASED ITS 2021 UPDATE, WHICH INCLUDES CLINICAL TEMPLATE SUITE ENHANCEMENTS FOR REGISTRY AUTOMATION AND MODEL CONTENT QUALITY, INCORPORATION OF PANDEMIC-RELATED LEARNING, ESTIMAND CLARIFICATIONS, AND ETEMPLATES TECHNICAL FRAMEWORK UPDATES, AMONG OTHER ITEMS.THE ESOURCE INITIATIVE RELEASED THE ESOURCE INFORMATICS CONTINUUM AND REFERENCE GUIDE FOR CLINICAL RESEARCH SITES, WHICH PROVIDES INFORMATION ON CLINICAL RESEARCH INFORMATICS, THE BASICS OF INFORMATICS, AND POSSIBLE RESOURCES TO EXPAND CAPABILITIES AROUND INTEROPERABILITY AND DATA EXCHANGE FOR CLINICAL SITES. IT IS ACCOMPANIED BY THE ESOURCE INFORMATICS CONTINUUM. THIS INITIATIVE CONTINUED PARTICIPATION AND LEADERSHIP IN VULCAN, AN HL7 FHIR ACCELERATOR. DATACELERATE UNDERWENT INFRASTRUCTURE ENHANCEMENTS ACROSS THE PLATFORM TO BETTER FACILITATE DATA SHARING.THE HISTORICAL TRIAL DATA SHARING INITIATIVE DEVELOPED AN ADOPTION FRAMEWORK: 5 ENABLERS OF DATA SHARING. THIS FRAMEWORK DETAILS THE KEY PRINCIPLES THAT CAN HELP PARTICIPANTS IN TRANSCELERATE DEVELOP DATA SHARING PROCESSES AND PROCEDURES.THE PRIVACY METHODOLOGY FOR DATA SHARING INITIATIVE DEVELOPED ITS FIRST-EVER OVERVIEW OF ITS BENEFITS AND GOALS.TRANSCELERATE'S INTELLIGENT AUTOMATION OPPORTUNITIES (IAO) IN PHARMACOVIGILANCE INITIATIVE PUBLISHED THE PAPER "VALIDATING INTELLIGENT AUTOMATION SYSTEMS IN PHARMACOVIGILANCE: INSIGHTS FROM GOOD MANUFACTURING PRACTICES." THE IAO INITIATIVE ALSO HELD KEY HEALTH AUTHORITIES MEETINGS WITH THE FDA, EMA, AND HEALTH CANADA TO DISCUSS ITS PROGRESS AND VALIDATION PROPOSAL. IN ADDITION, THE TEAM CONTINUED ITS COLLABORATION WITH MHRA DURING TWO SESSIONS AT DIA EUROPE. THE INTERPRETATION OF PHARMACOVIGILANCE GUIDANCES & REGULATIONS INITIATIVE COMMENCED WORK ON ITS NEWEST TOPIC CONCERNING THE MULTIPLE NEW REGULATORY GUIDELINES GOVERNING THE USE OF MEDICINES IN PREGNANCY AND BREASTFEEDING. THE PHARMACOVIGILANCE AGREEMENTS OPTIMIZATION (PVAO) INITIATIVE TEAM LAUNCHED ITS SOLUTIONS PAGE, AN INTERACTIVE PROCESS MAP, AND A GLOSSARY. THE VALUE OF SAFETY INFORMATION DATA SOURCES (VSIDS) INITIATIVE RELEASED THE INFOGRAPHIC "IDENTIFYING THE VALUE OF INFORMATION DATA SOURCES TO IMPROVE PATIENT SAFETY."BIOCELERATE'S COMMON TEMPLATES FOR NONCLINICAL STUDIES PRESENTED THE POSTER "SUPPORTING EFFICIENCIES IN NONCLINICAL TOXICOLOGY STUDIES THROUGH COMMON TEMPLATES" AT THE SOCIETY OF TOXICOLOGY ANNUAL MEETING AND PRESENTED THE POSTER "SUPPORTING EFFICIENCIES IN NONCLINICAL TOXICOLOGY STUDIES THROUGH PROTOCOL AND REPORT TEMPLATES: PROGRESS TOWARDS ADOPTION" AT THE AMERICAN COLLEGE OF TOXICOLOGY ANNUAL MEETING. THIS INITIATIVE ALSO COMPLETED ITS INTERNAL PHASE 1 PILOT WITH VOLUNTARY PARTICIPATION FROM ALL BIOCELERATE COMPANIES TO ASSESS THE VALUE AND FUNCTION OF ITS TEMPLATES COMPARED TO TEMPLATES USED BY PARTICIPATING COMPANIES.THE SEND HARMONIZATION FOR CROSS-STUDY ANALYSIS INITIATIVE EXTENDED ITS PUBLIC PRIVATE PARTNERSHIP (PPP) WITH THE U.S. FDA'S CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF COMPUTATIONAL SCIENCE TO CONTINUE TO CREATE RESOURCES AND TOOLS TO AID SEND IMPLEMENTATION FOR CROSS-STUDY ANALYSIS AND PUBLISHED ITS MANUSCRIPT "LEVERAGING THE VALUE OF CDISC SEND DATASETS FOR CROSS-STUDY ANALYSIS: INCIDENCE OF MICROSCOPIC FINDINGS IN CONTROL ANIMALS." AS PART OF A COLLABORATION WITH PHUSE, A WHITE PAPER "RECOMMENDATIONS FOR POPULATING CONTROL TYPE (TCNTRL) WITH CDISC SEND CONTROLLED TERMINOLOGY" WAS PUBLISHED. THE SEND INITIATIVE ALSO HOSTED THE "COLLABORATIVELY CRACKING THE SEND CODE: UNLOCKING THE POTENTIAL VALUE OF STANDARDIZED TOXICOLOGY STUDY DATA" WORKSHOP AT THE AMERICAN COLLEGE OF TOXICOLOGY ANNUAL MEETING.TOXICOLOGY & BACKGROUND CONTROL DATA SHARING SIGNIFICANTLY INCREASED THE NUMBER OF SEND FORMAT TOXICOLOGY AND BACKGROUND AND CONTROL STUDIES IN THE TOXICOLOGY DATA SHARING DATABASE AND LAUNCHED THE DATACELERATE SEARCH ENHANCEMENT RELEASE FOR THE TOXICOLOGY AND BACKGROUND CONTROL MODULES TO SIGNIFICANTLY ENHANCE THE USABILITY AND SEARCHABILITY OF THE TDS DATABASE.