TransCelerate BioPharma enters its second year with new members and an expanded agenda

Just over a year old now, TransCelerate BioPharma Inc. (Philadelphia) is expanding both its projects and its membership. The newest member of the nonprofit industry collaboration is Cubist Pharmaceuticals, which brings the total membership to 18, including the ten original founding companies.

TransCelerate is set up to coordinate “pre-competitive” activities that benefit drug discovery and development; most recently it set up a Clinical Trial Comparator Network to enable companies to obtain comparator drugs for clinical trials more efficiently. That, along with a (Clinical) Site Qualification and Training project, is now being expanded. Ongoing programs for risk-based monitoring of studies, clinical data standards and a Shared Investigator Portal are advancing.

To this list of programs, three new initiatives have begun:

• establishment of common clinical-trial protocol templates, to standardize review, endpoint and operational aspects of trial designs;
• a Special Populations Network, to gather investigators and patients focused on pediatric, adolescent and minority-group trial subjects.
• an Investigator Registry, to pool information on capabilities, resources and experience among investigators and study sites; this will expand the Shared Investigator Portal.

The founding membership of TransCelerate is AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, J&J, Pfizer, Roche and Sanofi. Additional members now include Astellas Pharma, Biogen Idec, Braeburn Pharmaceuticals, Cubist, EMD Serono, Forest Research Institute (part of Forest Laboratories), Onyx Pharmaceuticals and UCB. TransCelerate continues to solicit new members.