To be based in Philadelphia, TransCelerate BioPharma Inc. has the goal of gaining consensus on “precompetitive” industry practices that could accelerate the pace of product development. The 10 companies are: Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, J&J, Pfizer, Genentech (Roche), and Sanofi. The newly appointed acting CEO is Gary Neil, MD, a partner at Apple Tree Partners and former corporate VP, science & technology, at J&J.
According to a press statement, the group will “will combine financial and other resources, including personnel, to solve industry-wide challenges in a collaborative environment. Together, member companies have agreed to specific outcome-oriented objectives and established guidelines for sharing meaningful information and expertise to advance collaboration.” Five specific projects have already been targeted: 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 got some unofficial buy-in from FDA—CDER head Janet Woodcock siad “We applaud the companies . . . for joining forces to address a series of longstanding challenges in new drug development.” The group will also interact with numerous other industry alliances, including the Clinical Data Interchange Standards Consortium (CDISC), the Critical Path Institute, Clinical Trials Transformation Initiative and others.