Joint venture to take on some of the key challenges and bottlenecks in drug development
Ten of the largest pharmaceutical companies from Europe and the US have joined forces on a novel project that aims to revamp the process of new drug development.
The companies have all contributed financial resources and know-how into the project, which will operate under the banner of a non-profit organisation called TransCelerate BioPharma and take on some of the key challenges and bottlenecks in drug development today.
Rather than focusing on specific pharmaceutical development projects, the joint venture will concentrate on the process underlying drug development, trying to arrive at standardised, best-practice approaches.
It will work initially on the conduct of clinical trials, which is generally the most expensive part of drug development, for example by reducing the time it takes to enrol patients into studies.
With the cost of bringing a new drug to market now estimated at more than $1bn, according to an oft-cited study by Tufts University – pharma companies are looking for ways to streamline the process and avoid a situation in which promising candidates are languishing on the shelves.
The partners – Abbott Laboratories, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche/Genentech and Sanofi – hope that TransCelerate will be able to improve the quality of clinical research and help drugmakers bring medicines to market more quickly.
"There is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs," said the non-profit's CEO and former J&J executive Garry Neil.
TransCelerate will focus initially on five key areas, including the development of a shared user interface for investigator site portals, mutual recognition of study site qualification and training, and the development of a risk-based site-monitoring approach. The non-profit will also work on clinical data standards and a comparator drug supply model.
The JV will enlist the aid of a number of other organisations in its mission, including the US FDA and European Medicines Agency (EMA) as well as organisations involved in clinical research and data standards.