TY - JOUR
T1 - Coalition Against Major Diseases
T2 - Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases
AU - Stephenson, Diane
AU - Aviles, Enrique
AU - Bain, Lisa J.
AU - Brumfield, Martha
AU - Carrillo, Maria
AU - Comery, Thomas A.
AU - Compton, Carolyn
AU - Corrigan, Brian
AU - Gordon, Mark Forrest
AU - Jack, Clifford R.
AU - Katz, Russell
AU - Logovinsky, Veronika
AU - Satlin, Andrew
AU - Marek, Ken
AU - Nicholas, Timothy
AU - Polhamus, Dan
AU - Angersbach, B. Steven
AU - Raghavan, Nandini
AU - Romano, Gary
AU - Romero, Klaus
AU - Shaw, Leslie
AU - Woodcock, Janet
AU - Vradenburg, George
AU - Isaac, Maria
N1 - Funding Information:
Critical Path Institute’s Coalition Against Major Diseases is supported by the US Food and Drug Administration (grant U01FD003865) and Science Foundation Arizona (grant SRG 0335-08).
PY - 2013/11
Y1 - 2013/11
N2 - 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.
AB - 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.
KW - Alzheimer disease
KW - Parkinson disease
KW - biomarkers
KW - disease modeling
KW - regulatory qualification
UR - http://www.scopus.com/inward/record.url?scp=84886797572&partnerID=8YFLogxK
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U2 - 10.1177/2168479013498386
DO - 10.1177/2168479013498386
M3 - Article
AN - SCOPUS:84886797572
SN - 2168-4790
VL - 47
SP - 632
EP - 638
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 6
ER -