Striving for an Integrated drug-development Process for Neurodegeneration: the Coalition Against Major Diseases

Abstract

SUMMARY Alzheimer’s and Parkinson’s diseases are the two main neurodegenerative disorders and despite the public health need, drug development for these conditions has been plagued by a high attrition rate in the late phases of evaluation. In order to improve the efficiency of the drug development process for these conditions, the Coalition Against Major Diseases was formed by the Critical Path Institute in September 2008, in collaboration with the Engelberg Center for Health Care Reform at the Brookings Institution (Washington, DC, USA), with the aim of sharing precompetitive patient level data from legacy clinical trials, and transforming those data into generalizable and shareable knowledge in the form of drug development tools for Alzheimer’s and Parkinson’s diseases. As of May 2011, Coalition Against Major Diseases has 21 members (14 pharmaceutical companies and seven patient groups), joined by the US FDA, the European Medicines Agency, the National Institute of Aging and the National Institute of Neurological Disorders and Stroke. The drug development tools in development will take the form of biomarkers and modeling and simulation frameworks, and will be submitted for regulatory evaluation and qualification as ‘fit for purpose’ in the specific context of the drug development process for these diseases. This article constitutes a report of the progress of the work of the coalition in data standards, disease models and biomarkers.