Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neu rodegenerative Diseases

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 Nov 5, 2012, members of the scientific community, advocates, regulator...

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Published in:Therapeutic innovation & regulatory science 2013-11, Vol.47 (6), p.632
Main Authors: Stephenson, Diane, Aviles, Enrique, Bain, Lisa J, Brumfield, Martha, Carrillo, Maria, Comery, Thomas A, Compton, Carolyn, Corrigan, Brian, Gordon, Mark rest, Jack, Clifford R, Katz, Russell, Logovinsky, Veronika, Satlin, Andrew, Marek, Ken, Nicholas, Timothy, Polhamus, Dan, Angersbach, B Steven, Raghavan, Nandini, Romano, Gary, Romero, Klaus, Shaw, Leslie, Woodcock, Janet, Vradenburg, George, Isaac, Maria
Format: Article
Language:English
Subjects:
Alzheimer's disease
Biomarkers
Clinical trials
Critical path
Design
Patients
Pharmaceutical industry
Regulatory agencies
Regulatory approval
Studies
Success
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Summary: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 Nov 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.
ISSN:2168-4790
2168-4804