Ten of the world's leading pharmaceutical companies have formed a non-profit organisation, called TransCelerate BioPharma, to accelerate the development of new medicines.
The companies - Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche and Sanofi - are getting together to "identify and solve common drug development challenges with the end goals of improving the quality of clinical studies". Although a number of firms have signed bilateral deals in this area, this is the largest ever initiative of its kind.
TransCelerate will be headed up by Garry Neil, a partner at Apple Tree Partners and former head of science and technology with J&J. He told PharmaTimes World News that "we are all pretty fierce competitors", an approach "that has served us well" but it has become clear that the industry is struggling to deal with inefficiencies that drive up R&D costs. For example, poor processes in terms of collecting clinical data showed that in this case, "competition does not increase efficiency".
TransCelerate, which is the result of talks within the influential Hever group of R&D directors, representing many of the top pharmaceutical companies, has identified "clinical study execution as the initiative's initial area of focus". Five projects have been selected for funding, including the development of a shared user interface for investigator site portals and clinical data standards, as well as the establishment of a comparator drug supply model.
Each of the ten founding companies will combine financial and other resources, including personnel, to the project. Mr Neil declined to give specific details about the financials, merely the funding is "substantial". However, he did note that the firms with bigger R&D budgets will contribute more.
He told PT that he hopes other drugmakers, including smaller players, will take part in the initiative. Mr Neil added that TransCelerate, which will be based in Philadelphia, also consulted with the US Food and Drug Administration and the European Medicines Agency and the response has been extremely positive from regulators, as well as public/private alliances and contract research organisations.
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said "this collaborative approach in the pre-competitive arena, utilising 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 this will "strengthen the industry and its ability to develop innovative and much-needed therapies", she added.
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