Coalition Against Major Diseases

Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases

Diane Stephenson, Enrique Aviles, Lisa J. Bain, Martha Brumfield, Maria Carrillo, Thomas A. Comery, Carolyn Compton, Brian Corrigan, Mark Forrest Gordon, Clifford R. Jack, Russell Katz, Veronika Logovinsky, Andrew Satlin, Ken Marek, Timothy Nicholas, Dan Polhamus, B. Steven Angersbach, Nandini Raghavan, Gary Romano, Klaus Romero & 4 others Leslie Shaw, Janet Woodcock, George Vradenburg, Maria Isaac

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)632-638
Number of pages7
JournalTherapeutic Innovation and Regulatory Science
Volume47
Issue number6
DOIs
StatePublished - Nov 2013

Fingerprint

Neurodegenerative Diseases
Industry
Pharmaceutical Preparations
Essential Drugs
Critical Pathways
Information Dissemination
United States Food and Drug Administration
Parkinson Disease
Alzheimer Disease
Chronic Disease
Biomarkers
Outcome Assessment (Health Care)
Therapeutics
Government Employees

Keywords

  • Alzheimer disease
  • biomarkers
  • disease modeling
  • Parkinson disease
  • regulatory qualification

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Public Health, Environmental and Occupational Health
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Cite this

Coalition Against Major Diseases : Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases. / Stephenson, Diane; Aviles, Enrique; Bain, Lisa J.; Brumfield, Martha; Carrillo, Maria; Comery, Thomas A.; Compton, Carolyn; Corrigan, Brian; Gordon, Mark Forrest; 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.

In: Therapeutic Innovation and Regulatory Science, Vol. 47, No. 6, 11.2013, p. 632-638.

Research output: Contribution to journalArticle

Stephenson, D, Aviles, E, Bain, LJ, Brumfield, M, Carrillo, M, Comery, TA, Compton, C, Corrigan, B, Gordon, MF, Jack, CR, Katz, R, Logovinsky, V, Satlin, A, Marek, K, Nicholas, T, Polhamus, D, Angersbach, BS, Raghavan, N, Romano, G, Romero, K, Shaw, L, Woodcock, J, Vradenburg, G & Isaac, M 2013, 'Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases', Therapeutic Innovation and Regulatory Science, vol. 47, no. 6, pp. 632-638. https://doi.org/10.1177/2168479013498386
Stephenson, Diane ; Aviles, Enrique ; Bain, Lisa J. ; Brumfield, Martha ; Carrillo, Maria ; Comery, Thomas A. ; Compton, Carolyn ; Corrigan, Brian ; Gordon, Mark Forrest ; 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. / Coalition Against Major Diseases : Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases. In: Therapeutic Innovation and Regulatory Science. 2013 ; Vol. 47, No. 6. pp. 632-638.
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