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”.