Date: 2012-09-19
Type of information: Clinical research agreement
Compound: clinical study execution
Company: Abbott (USA), AstraZeneca (UK), Boehringer Ingelheim (Germany), BMS (USA), Eli Lilly (USA), GSK (UK), Johnson & Johnson (USA), Pfizer (USA - NY), Genentech a member of the Roche Group (USA-Switzerland), and Sanofi (France)
Therapeutic area:
Type agreement: R&D
clinical research
Action mechanism:
Disease:
Details: Ten leading biopharmaceutical companies (Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi) have formed a non-profit organization to accelerate the development of new medicines. TransCelerate BioPharma Inc. is the largest ever initiative of its kind, to identify and solve common drug development challenges with the end goals of improving the quality of clinical studies and bringing new medicines to patients faster.
Through participation in TransCelerate, each of the ten founding companies 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.
Members of TransCelerate have identified clinical study execution as the initiative\'s initial area of focus. Five projects have been selected by the group for funding and development, including: 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.
As shared solutions in clinical research and other areas are developed, TransCelerate will involve industry alliances including Clinical Data Interchange Standards Consortium (CDISC), Critical-Path Institute (C-Path), Clinical Trials Transformation Initiative (CTTI), Innovative Medicines Initiative (IMI), regulatory bodies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Contract Research Organizations (CROs).
TransCelerate was incorporated in early August 2012 and will file for non-profit status this fall. The Board of Directors includes R&D heads of ten member companies. Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. TransCelerate\'s headquarters will be located in Philadelphia, PA.
Financial terms:
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