Launched a decade ago, the US Food and Drug Administration's Critical Path Initiative has helped catalyse the formation of many consortia focused on drug development challenges. In this Focus, representatives from some of the major stakeholder groups and consortia describe their roles, summarize progress so far and provide their perspectives on the opportunities, challenges and lessons learned for biomedical consortia in general.
Foreword
The driving role of consortia on the critical path to innovative therapies
Janet Woodcock, Martha Brumfield, Dalvir Gill & Elias Zerhouni
doi:10.1038/nrd4462
Nature Reviews Drug Discovery 13, 781 (2014)
Launched a decade ago, the US Food and Drug Administration's Critical Path Initiative has helped catalyse the formation of many consortia focused on drug development challenges.
Comments
Paving the critical path of drug development: the CDER perspective
Janet Woodcock
doi:10.1038/nrd4435
Nature Reviews Drug Discovery 13, 783-784 (2014)
Improving the science of drug development and regulation is important in fulfilling the public health mission of the US Food and Drug Administration (FDA). A decade on from the launch of the Critical Path Initiative, the FDA's Center for Drug Evaluation and Research (CDER) is now participating in more than 20 science-driven consortia to achieve this goal.
The Critical Path Institute: transforming competitors into collaborators
Martha Brumfield
doi:10.1038/nrd4436
Nature Reviews Drug Discovery 13, 785-786 (2014)
The Critical Path Institute brings scientists from regulatory agencies, industry and academia together to improve drug development and regulatory processes.
Re-inventing clinical trials through TransCelerate
Dalvir Gill
doi:10.1038/nrd4437
Nature Reviews Drug Discovery 13, 787-788 (2014)
TransCelerate BioPharma was formed in 2012 as a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines.
The role of public–private partnerships in addressing the biomedical innovation challenge
Maya Said & Elias Zerhouni
doi:10.1038/nrd4438
Nature Reviews Drug Discovery 13, 789-790 (2014)
Without a step change in the productivity of pharmaceutical research and development, it will be difficult to tackle the public health challenges facing societies worldwide. Public–private partnerships could play a key role in achieving this step change, but they need to be well designed and led.
The Biomarkers Consortium
David Wholley
doi:10.1038/nrd4439
Nature Reviews Drug Discovery 13, 791-792 (2014)
The Biomarkers Consortium is a public–private biomedical research partnership that seeks to develop and qualify biomarkers across a broad range of diseases in order to accelerate the development of new medicines and improve patient care.
The Predictive Safety Testing Consortium and the Coalition Against Major Diseases
Diane Stephenson & John-Michael Sauer
doi:10.1038/nrd4440
Nature Reviews Drug Discovery 13, 793-794 (2014)
The Predictive Safety Testing Consortium and the Coalition Against Major Diseases, both launched by the Critical Path Institute, provide valuable examples of the outcomes and lessons learned by different types of consortia working on new drug development tools.
The International Serious Adverse Events Consortium
Arthur L. Holden, Jorge L. Contreras, Sally John & Matthew R. Nelson
doi:10.1038/nrd4441
Nature Reviews Drug Discovery 13, 795-796 (2014)
The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.
The Clinical Trials Transformation Initiative: innovation through collaboration
Pamela Tenaerts, Leanne Madre, Patrick Archdeacon & Robert M. Califf
doi:10.1038/nrd4442
Nature Reviews Drug Discovery 13, 797-798 (2014)
The Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.
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