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Pharmas to Collaborate on Improving Clinical Trial Process

Pills and drug bottles (FDA.gov)

(FDA.gov)

Ten of the world’s larger pharmaceutical companies formed a non-profit organization to improve the way clinical drug studies, a major time and financial expense, are conducted. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech (a division of the Roche Group), and Sanofi will take part in the organization called TransCelerate BioPharma Inc., which will be based in Philadelphia.

“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,” says Garry Neil, TransCelerate’s acting CEO. Neil is a partner at the life sciences venture capital firm Apple Tree Partners and previously the vice-president for science and technology at Johnson & Johnson.

The TransCelerate participants highlighted the conduct of clinical studies as the initiative’s main target, with five projects selected for funding and development:

- 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

- Establishment of a comparator drug supply model

TransCelerate plans to work with related industry groups such as Clinical Data Interchange Standards Consortium, Critical-Path Institute, Clinical Trials Transformation Initiative, and Innovative Medicines Initiative. The organization also expects to collaborate with regulatory bodies including the Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency.

“This collaborative approach in the pre-competitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, “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.”

TransCelerate was incorporated in August 2012 and plans to file for non-profit status this fall. The organization says it will be open to all pharmaceutical and biotechnology companies who can contribute to and benefit from its shared solutions.

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