In the latest acknowledgment of drug-development struggles in pharma, 10 of the world's largest drugmakers have joined forces to form a nonprofit that aims to address some of the issues that stymie progress of new meds onto the market. And TransCelerate BioPharma, the new nonprofit, has already established a slate of early projects that could benefit the entire group of founding pharmas.
The herd of pharma heavyweights behind TransCelerate includes Abbott ($ABT), AstraZeneca ($AZN), Boehringer Ingelheim, Bristol-Myers Squibb ($BMY), Eli Lilly ($LLY), GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ), Pfizer ($PFE), Roche's ($RHHBY) Genentech unit, and Sanofi ($SNY). All of the companies are grappling with extremely high R&D costs, and their stated hope for their collaborative effort at Philadelphia-based TransCelerate is to boost the quality of clinical trials and speed up the typically slow pace of drug development.
Janet Woodcock, the FDA's chief of drug regulation, gave a nod to the drugmakers' collaborative spirit and its potential to help patients in a prepared statement. "We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development. This collaborative approach in the pre-competitive arena, utilizing 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 which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients."
TransCelerate, formed in August, has recently tapped an acting CEO, Dr. Garry Neil, a partner at the life sciences investment firm Apple Tree Partners and the former corporate VP of science and technology at J&J. The nonprofit's supporters have agreed to fund 5 initial projects that include: "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, and establishment of a comparator drug supply model," the group said in its press release.
These are the types of pre-competitive projects that could help all of the pharma groups reduce some of the nettlesome issues that contribute to poor returns on R&D investments. The pharma groups have a multibillion-dollar problem on their hands. Earlier this year, research cited in Forbes showed that major drugmakers' actual costs of bringing a new drug to market, after accounting for failed programs and other expenses, was a whopping $4 billion on average, dwarfing the already sizable estimate of $1 billion for every new drug that had been used in industry circles for years.
- here's the release