Conference Proceeding
Alzheimer's and Parkinson's Diseases Face Common Challenges in Therapeutic Development: Role of the Precompetitive Consortium, Coalition Against Major Diseases
Diane Stephenson1*, Martha Brumfield1, Klaus Romero1, Janet Woodcock2, Issam Zineh2, Eric M Reiman3, Caroline Tanner4, Richard Mohs5, Walter Koroshetz6, Timothy Nicholas7, Lisa J Bain8, Derek Hill9, Les Shaw10, Johan Luthman11, Michael Ropacki12, Richard Meibach13, Peter Loupos14, Ken Marek15, James Hendrix16, Eric Karran17, George Vradenburg18, Keiju Motohashi19, Jesse M Cedarbaum20 and Mark Forrest Gordon21
1Critical Path Institute, CAMD, Tucson, AZ, USA
2Office of Clinical Pharmacology, FDA, New Hampshire Ave, Silver Spring, USA
3Banner Alzheimer’s Institute, AZ, USA
4University of California – San Francisco, San Francisco, CA, USA
5Lilly Corporate Center, Indianapolis, IN, USA
8Independent Scientific & Medical Writer, Elverson, PA, USA
10Hospital of the University of Pennsylvania, Philadelphia, PA, USA
12Janssen R&D, South San Francisco, CA, USA
13Novartis,East Hanover, NJ, USA
14Sanofi, Bridgewater, NJ, USA
15Institute for Neurodegenerative Disorders, New Haven, CT, USA
16Alzheimer’s Association, Chicago, IL, USA
17Alzheimer’s Research UK, Cambridge,UK
18USAgainstAD, Washington, DC, USA
19Office of New Drug II,The University of Tokyo Hospital, Tokyo, Japan
20Neurology Clinical Development, Cambridge, MA
21Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA
- 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: dstephenson@c-path.org
Received date: February 25, 2015; Accepted date: March 14, 2015; Published date: 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.
Abstract
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 theadvancement 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.