Pharma creates non-profit R&D organisation
pharmafile | September 21, 2012 | News story | Research and Development, Sales and Marketing | Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Co, GlaxoSmithKline, Johnson & Johnson, Pfizer, R&D, Roche Genentech, Sanofi, TransCelerate BioPharma, biopharma
Ten biopharma companies have formed TransCelerate BioPharma Inc, a not-for-profit organisation using money and personnel from each firm, with a mission to speed up the development of new medicines.
The firms involved are: Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Co, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche’s Genentech and Sanofi.
The cost of R&D and a move away from blockbusters towards personalised medicines has seen manufacturers seek new models for finding and developing drugs in recent years.
“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,” said Garry Neil, TransCelerate’s newly-appointed acting chief executive.
Clinical study execution is to be the initiative’s initial area of focus and Neil, a former corporate vice president, science & technology, at Johnson & Johnson, added that the new venture would share research and best practice.
Membership is open to all pharma and biotech companies “who can contribute to and benefit from these shared solutions”.
Billed as the largest initiative of its kind, TransCelerate will be based in Philadelphia and has already identified five projects to work on:
- 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.
As time goes on, TransCelerate’s plan is to work more closely with research organisations, regulatory bodies including the EMA and FDA, and other pharma alliances such as the Clinical Data Interchange Standards Consortium, Critical-Path Institute and Clinical Trials Transformation Initiative (CTTI).
CTTI co-chair Robert Califf said that the ten companies are in a position to “significantly influence changes in the way that clinical trials are done, so that better answers about the benefits and risks of drugs and other therapies are provided in a more efficient manner”.
The FDA also welcomed the move, saying it had “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”.
Adam Hill
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