Alzheimer’s and Parkinson’s Diseases Face Common Challenges in Therapeutic Development: Role of the Precompetitive Consortium, Coalition Against Major Diseases

نویسندگان

  • Diane Stephenson
  • Martha Brumfield
  • Klaus Romero
  • Janet Woodcock
  • Issam Zineh
  • Eric M Reiman
  • Caroline Tanner
  • Richard Mohs
  • Walter Koroshetz
  • Mark Forrest
چکیده

Alzheimer’s disease (AD) and Parkinson’s disease (PD) pose significant challenges for successful development of new therapies, with anextremely high drug trial failure rate and yet no approved disease modifying drugs available. Given the magnitude of the challenges, it has become clear that larger collaborations and multi-partner joint efforts, pooling resources and expertise,are required for the advancement of methods and tools that are critically needed to support drug development studies. Critical Path Institute’s Coalition against Major Diseases was formed in 2008, at a time prior to the era of public private partnerships, with the mission of streamlining and de-risking drug development for AD and PD. Since its origin, the consortium has achieved several milestones including development of consensus data standards for AD and PD, a unified clinical trial database comprised of placebo data from AD therapeutic trials and regulatory endorsement of drug development tools. In addition, the consortium is progressing strongly on other initiatives, with ongoing regulatory interactions. The coalition held its annual conference at the U.S. Food and Drug Administration, where diverse stakeholders including industry, academic experts, government agency representatives, patient advocacy organizations and regulators gathered together to share their accomplishments and focus on the needs of the future. The current landscape was emphasized with focus on the need to expand the precompetitive space and enhance data sharing globally. *Corresponding author: Diane Stephenson, PhD, Critical Path Institute, 1730 E. River Road, Tucson, AZ 85718, Tel: 520-382-1405; Fax: 520-547-3456; E-mail: [email protected] Received February 25, 2015; Accepted March 14, 2015; Published March 31, 2015 Citation: Stephenson D, Brumfield M, Romero K, Woodcock J, Zineh I, et al. (2015) Alzheimer’s and Parkinson’s Diseases Face Common Challenges in Therapeutic Development: Role of the Precompetitive Consortium, Coalition Against Major Diseases. J Alzheimers Dis Parkinsonism 5: 183. doi: 10.4172/2161-0460.1000183 Copyright: © 2015 Stephenson D, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. academic, advocacy and industry partners together with regulatory agencies to identify areas of common interest and projects that can be executed collaboratively in the pre-competitive space. Citation: Stephenson D, Brumfield M, Romero K, Woodcock J, Zineh I, et al. (2015) Alzheimer’s and Parkinson’s Diseases Face Common Challenges in Therapeutic Development: Role of the Precompetitive Consortium, Coalition Against Major Diseases. J Alzheimers Dis Parkinsonism 5: 183. doi: 10.4172/2161-0460.1000183

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تاریخ انتشار 2015