TransCelerate Launches New Initiatives to Support Continuity of Clinical Trials, Real World Data, COVID-19 Research and PharmacovigilanceOctober 19, 2020
Consortium also elects new Board leadership and increases size of membership
PHILADELPHIA–(BUSINESS WIRE)–TransCelerate Biopharma Inc. (TransCelerate) announced today that it has launched a number of new initiatives to improve the research and development of medicines. These new initiatives further TransCelerate’s mission to collaborate across the global biopharmaceutical research and development community to identify, prioritize and facilitate implementation of solutions designed to deliver new medicines efficiently, effectively and with high-quality. Additionally, the organization expanded its membership with the addition of Bayer Pharmaceuticals.
The organization has launched the following initiatives:
DataCelerate® COVID-19 Module
- As part of the organization’s response to the pandemic, a new module was created in the DataCelerate® data-sharing platform to enable patient-level data sharing of both the investigational product and control arms of COVID-19 clinical trials, along with supporting documentation. Access to the COVID-19-related clinical trial data is available to TransCelerate Member Companies, qualifying non-member biopharmaceutical companies, and select government biomedical research agencies who satisfy minimum eligibility criteria.
Modernizing Clinical Trial Conduct
- The Modernizing Clinical Trial Conduct Initiative was also approved in response to the pandemic and will use data and experience to develop practical guidance and solutions to further enable the success of continuity solutions implemented during COVID-19. These learnings can be used to inform future ways of working for industry as well as future policy by regulators. TransCelerate is collaboratively engaging with regulatory agencies, patients, sites, CROs and industry groups to develop solutions detailing how to enable and execute new methods for drug development. This initiative has already published a catalyst paper and has developed five continuity solution case studies.
Real World Data
- Supplementing or replacing clinical trial data with Real World Data (RWD) to inform regulatory decisions is a transformative, ambitious goal which can benefit both patients and researchers. RWD has the potential to substantially contribute to the totality of evidence regarding benefits and risks of drug products. (Read more…) 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.
Pharmacovigilance Agreements Optimization
- As the number of pharmacovigilance agreements (PVAs) between companies that require an exchange of safety information are continually increasing, this initiative seeks to produce a customizable resource for new and experienced contract partners, which could be used to inform and/or streamline PVA process development, contract drafting and negotiations.
“The world has changed drastically in the last several months, disrupting all aspects of R&D and forcing our industry to quickly adapt,” said Badhri Srinivasan, Head, Global Development Operations, Novartis and a member of TransCelerate’s Board of Directors. “These initiatives, both individually and in conjunction with other existing initiatives in the TransCelerate portfolio, allow stakeholders to nimbly adapt for continuity of patient care in clinical trials and accelerate new ways of working to create innovative new medicines. TransCelerate has provided us with a forum to come together for a common good and transcend beyond individual companies’ needs. Our success through collectively responding to COVID-19 is more important now than ever before to prepare us for future events where pharma will need to be ‘disruption proof.’”
Change in Leadership
Robert Baker, MD, Vice President, Clinical Program Design and Exploratory Medicine/Pharmacology, Eli Lilly and Company, was appointed Corporate Secretary of TransCelerate.
“Robert is an established leader in the biopharmaceutical industry, and we are incredibly fortunate to have him in a TransCelerate leadership role,” said Dalvir Gill, PhD, CEO of TransCelerate BioPharma Inc. “Robert has worked with us as a member of the Pharmacovigilance Steering Committee and he has played an active role in the shaping and launching of TransCelerate’s growing pharmacovigilance portfolio.”
Bayer, a global life science company with more than a 150-year history, became a member of TransCelerate early in 2020. Its participation will further TransCelerate’s mission and contribute to finding solutions to some of research & development’s most pressing health challenges. Steffen Roellinger, PhD, Senior Vice President, Head of Clinical Operations at Bayer, has joined TransCelerate’s Board of Directors.
“We had explored joining TransCelerate for the past few years,” said Roellinger. “We ultimately joined because we were impressed with how much the organization has accomplished in a few short years. It is critical to be part of this organization given the substantial challenges and opportunities stemming from the digital transformation of our business. By adding Bayer’s passionate and experienced R&D colleagues, with the roster of talent already established in TransCelerate’s Member Companies, we can make a substantial impact in how R&D evolves for the better in the coming years.”
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-/.
Leigh Anne Minnier
Bliss Integrated Communication for TransCelerate