PHILADELPHIA--(BUSINESS WIRE)--TransCelerate BioPharma Inc., a non-profit dedicated to streamlining and accelerating the research and development of innovative new therapies, today announced it has committed to an expansion of its clinical and drug safety portfolio, revealing the following new initiatives:
- The Common Clinical Serious Adverse Events (SAE) Fields Initiative intends to conduct a feasibility assessment, develop best practices relating to identifying the most critical SAE fields, and work with an industry standard setting organization to promulgate standards in this area, all with the intent of increasing the quality of what is reported and creating efficiencies for sites, CROs and regulators.
- The Modernization of Data Analytics for Clinical Development Initiative aims to analyze methods for considering and validating novel statistical computing platforms to propose to Health Authorities and better enable them to support these platforms.
- Due to the success of the Interpretation of Guidances and Regulations Initiative launched in drug safety in 2018, the initiative has expanded in scope from strictly pharmacovigilance to include clinical guidances and regulations. For its first deliverable, the workstream is creating a Quality Tolerance Limits Framework to help facilitate clinical trial compliance. The framework will propose interpretations of clinical regulations and seek to foster harmonization across health authorities by proactively sharing recommendations that reduce the amount of duplicative efforts and audit findings.
“These three new initiatives are fully aligned with our strategic priorities and future roadmap. We expect these deliverables to enhance our prior investments and to deliver quick and tangible value to our members and other stakeholders,” said Janice Chang, Executive Vice President, TransCelerate BioPharma Inc. “Furthermore, as multiple stakeholders adopt our work globally, we have significantly ramped up our engagement with health authorities who are increasingly eager to collaborate with TransCelerate to solve common problems. Broader global adoption of our work is complemented by Member Company networks in over 30 countries that apply regional, cultural and regulatory implications to our initiatives.”
Echoing Ms. Chang’s sentiment, Badhri Srinivasan, Head, Global Development Operations, Novartis noted, “One of the strengths of TransCelerate is that it engages key groups across the Research and Development landscape to find opportunities for streamlining. This includes getting the right input from patients, investigative sites, academic researchers, clinical research organizations and health authorities to incorporate into collaborative approaches. Since joining TransCelerate less than two years ago, we have been very active contributors in multiple successful initiatives as well as adopting a number of solutions.”
Expanding Its Regulatory Reach
The TransCelerate clinical and drug safety portfolio now consists of 30 initiatives supported by significant in-kind resource contributions from TransCelerate members. The drug safety team recently met with several health authorities to inform thinking for upcoming deliverables. Specifically, TransCelerate’s Value of Safety Information Data Sources initiative has met with the Food & Drug Administration, the Medicines and Healthcare Products Regulatory Agency and presented to the Pharmaceuticals and Medical Devices Agency in Japan and the European Medicines Agency’s Operation of European Union Pharmacovigilance industry stakeholder platform meeting. Additionally, it has written two position papers for journal publication: “Patient Support Programs, Market Research Programs, and Social Media Provide Limited Value to Patient Safety” and “Issues with Pooling Reports from Solicited Sources Together with Spontaneous Reporting.”
TransCelerate Welcomes Prominent Industry Member
Regeneron, a leading U.S. biotechnology company, has joined TransCelerate as its 20th member. Regeneron’s seven FDA-approved medicines are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.
David Weinreich, MD, MBA, Senior Vice President, Global Clinical Development at Regeneron commented, “We applaud the organization for its work in streamlining drug development. By sharing its work publicly, TransCelerate benefits the entire ecosystem as we look to modernize drug development to achieve our shared mission of getting innovative therapies to patients faster. Regeneron looks forward to working alongside TransCelerate’s other members to lend our expertise and solve the most pressing issues affecting R&D today.”
About TransCelerate BioPharma, Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by streamlining and accelerating 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, prioritize, design and facilitate implementation of solutions intended to drive the efficient, effective and high-quality delivery of new medicines. The vast majority of TransCelerate solutions are publicly available. Headquartered in Philadelphia, TransCelerate has 20 member companies and 30 initiatives focused on improving the patient and site experience, enhancing sponsor efficiencies and drug safety and, as appropriate, harmonizing process and sharing information.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with R&D operations. For more information, please visit http://www.transceleratebiopharmainc.com, https://twitter.com/TransCelerate, or https://www.linkedin.com/company/transcelerate-biopharma-inc-/.