1. Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases
- Author
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Dan Polhamus, Clifford R. Jack, Timothy Nicholas, Enrique Aviles, Russell Katz, Leslie M. Shaw, Maria C. Carrillo, Martha Brumfield, Nandini Raghavan, Klaus Romero, Janet Woodcock, Brian Corrigan, Veronika Logovinsky, Lisa J. Bain, Diane Stephenson, George Vradenburg, Mark Forrest Gordon, Andrew Satlin, Ken Marek, B. Steven Angersbach, Carolyn C. Compton, Maria Isaac, Thomas A. Comery, and Gary Romano
- Subjects
medicine.medical_specialty ,Government ,Drug trial ,business.industry ,Public Health, Environmental and Occupational Health ,Alternative medicine ,Pharmacy ,Disease ,Pharmacology ,Data sharing ,Drug development ,Medicine ,Pharmacology (medical) ,Engineering ethics ,Drug-disease ,business ,Pharmacology, Toxicology and Pharmaceutics (miscellaneous) - Abstract
Precompetitive collaborations have been successful in several disease areas and industries. Such collaborations are critical to address the gaps and challenges in therapeutic development for chronic neurodegenerative diseases. On November 5, 2012, members of the scientific community, advocates, regulators, industry, and government officials met at the US Food and Drug Administration to develop tools to expedite drug development and maximize the potential for success in future drug trials for Alzheimer disease and Parkinson disease. The meeting established that multiple collaborative approaches are essential for accelerating drug development. Such approaches include precompetitive data sharing, regulatory qualification of biomarkers and clinical outcome assessments, implementation of data standards, and development of quantitative drug disease trial models. While challenges to collaboration among industry partners are formidable, they are not insurmountable. The Coalition Against Major Diseases (CAMD) has several positive examples to highlight. This review represents proceedings from CAMD's annual conference and discusses the key themes that are being advanced by the Critical Path Institute.
- Published
- 2013
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