阿尔茨海默病和帕金森病杂志

抽象的

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

Diane Stephenson, Martha Brumfield, Klaus Romero, Janet Woodcock, Issam Zineh, Eric M Reiman, Caroline Tanner, Richard Mohs, Walter Koroshetz, Timothy Nicholas, Lisa J Bain, Derek Hill, Les Shaw, Johan Luthman, Michael Ropacki, Richard Meibach, Peter Loupos, Ken Marek, James Hendrix, Eric Karran, George Vradenburg, Keiju Motohashi, Jesse M Cedarbaum and

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.