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GEN News Highlights : Sep 19, 2012
Drug Giants Establish Problem-Solving Initiative
Ten major global drug firms have teamed up to establish and fund a nonprofit organization focused on ultimately speeding drug development by addressing a range of existing challenges. Slated as the largest ever initiative of its kind, TransCelerate Biopharma will initially target issues in clinical study execution.
The organization’s founding partners are Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche’s Genentech, and Sanofi. Each will combine financial and other resources, including personnel, and have agreed specific outcome-orientated objectives and guidelines for sharing data and expertise.
Five clinical trials-related projects have been for initial funding and development. These include: development of a shared-user interface for investigator site portals; mutual recognition of study-site qualification and training; development of risk-based site monitoring approach and standards; development of clinical data standards; and establishment of a comparator drug supply model. The firms say that as solutions in clinical research and other areas are developed it will draw in other relevant industry alliances and regulatory bodies, including the Clinical Data Interchange Standards Consortium (CDISC), Critical-Path Institute (C-Path), the Clinical Trials Transformation Initiative (CTT), Inovative Medicines Initiative (IMI), FDA, and the European Medicines Agency (EMA), as well as contract research organizations.
TransCelerate is headed by CEO Garry Neil, M.D., a partner at Apple Tree Partners and formerly corporate vp for science and technology at Johnson & Johnson. “There is widespread alignment among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs,” he explains. “Our mission at TransCelerate BioPharma is to work together across the global research and development community and share research and solutions that will simplify and accelerate the delivery of exciting new medicines for patients.”
FDA has welcomed the move. “We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development,” states Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “This collaborative approach in the precompetitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.”
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