Coalition Against Major Diseases (CAMD)
Public Health Context:
The development of effective treatments to stem the progression of neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease remains a major public health challenge. Current treatments are primarily symptomatic. In order to facilitate the successful development of treatments that can modulate disease progression, important improvements in the fundamental understanding of disease progression as well as improved assessment tools such as biomarkers to support clinical trials will be needed. Resources required for the success of these efforts exceed the ability of single organizations, and will require the collaborative efforts of multiple partners from industry, academia, patient advocacy groups and government.
Mission & Program Objectives:
The CAMD's focus is to develop new tools (biomarkers and disease progression models) and methods that can be applied during the development of new treatments for neurodegenerative diseases. Specific goals include:
- Establishing a database of pooled data from controls in industry clinical trials.
- Developing quantitative disease progression models for Parkinson’s disease and Alzheimer’s disease and making them available for scientists world wide.
- Defining common data element standards (Clinical Data Interchange Standards Consortium [CDISC]) for neurodegenerative diseases.
- Identifying imaging, biochemical, genetic, and molecular biomarkers that have the greatest potential to identify patient populations.
- Submitting the evidence necessary for the FDA and EMA to officially designate such tools as "qualified for use" in drug development.
- Obtaining commitment from major pharmaceutical companies to utilize CDISC standards for all medical products for neurodegenerative disease.
Accomplishments as of August 2010:
- Establishment of four workgroups on: Data (Sources, Standards, Sharing, and Infrastructure), Disease Progression Modeling, Biomarker Evaluation, and Regulatory Authority Submissions.
- Completion of a work scope for CAMD
- Development of a database of placebo data from 11 clinical trials in Alzheimer’s disease.
- Development of a disease progression model for Alzheimer’s disease using data from the NIH-sponsored Alzheimer’s Disease Neuroimaging Initiative (ADNI) database. A briefing package was submitted to the FDA in December 2009 for formal review. Feedback was provided by FDA in April of 2010 and has been incorporated into the model.
- The CAMD data working group developed a standardized Alzheimer’s Disease Assessment Scale-Cognitive subscale ADAS-Cog cognition measurement instrument, other clinical scales and biomarker data. A proposal for the imaging standards has been reviewed by the FDA. FDA provided feedback on 4/14/10 and this has been incorporated into the standards.
- A public announcement of the availability of the CAMD database of 4000 patients with Alzheimer’s disease was held on June 11th, 2010, the database was made available to qualified researchers.
CAMD was formed by the non-profit Critical Path Institute (C-Path), in cooperation with the U.S. Food and Drug Administration (FDA), patient organizations, the medical products industry and the Engelberg Center for Health Care Reform at the Brookings Institution. As a 501(c)(3), the Critical Path Institute serves as a recognized and respected neutral third party convener.
C-Path, with support from the FDA and the State of Arizona, provides a Director, Assistant Directors and staff who manage the Consortium, coordinate planning and implementation of all projects, and provide financial oversight of research expenditures. The consortium members contribute expertise, data, information and the necessary research funding to implement each consortium’s research activities. Academic, government and non-profit experts provide technical advice.
U.S. Food and Drug Administration
European Medical Agency (EMA)
Engelberg Center for Health Care Reform
at the Brookings Institution
National Institute of Neurological Disorders
and Stroke (NINDS)
National Institute on Aging (NIA)
AstraZeneca Pharmaceuticals LP
Bristol-Myers Squibb Company
Eli Lilly and Company
F. Hoffmann-La Roche Ltd.
Forest Research Institute
Johnson & Johnson, LLC
Novartis Pharmaceuticals Corporation
sanofi-aventis U.S., Inc.
Alliance for Aging Research
Alzheimer’s Foundation of America
CHDI Foundation, Inc.
National Health Council (NHC)
Parkinson’s Action Network
Parkinson’s Disease Foundation