Prof. Hill will take part in the AD Biomarkers Evaluation Workgroup, which aims to establish a process and execute a plan for compiling and evaluating the scientific merit of reported biomarkers including imaging
(PRWEB) January 28, 2010
The initial goal of CAMD is to define clinical data standards and establish a pooled database of the control groups of pharmaceutical clinical trials in order to develop quantitative disease progression models for both Alzheimer's and Parkinson's diseases.
The CAMD brings together major pharmaceutical companies, the US Food and Drug Administration (FDA), the European Medicine Agency (EMEA), the National Institute on Aging (NIA), the National Institute of Neurological Disorders and Stroke (NINDS), and patient groups in a collaboration to develop new knowledge that will enhance the medical product industry’s ability to develop innovative new therapies. The objective is to establish CAMD as a neutral ground where the regulatory agencies (FDA, EMEA), pharmaceutical industry (16 members so far), patient advocacy groups, and government agencies (NINDS and NIA) can come together to discuss the science with the aim of packaging it in a form that is actionable by the regulatory agencies. The members are the stakeholders in the therapeutics enterprise and the output from CAMD is reflective of both the science and the needs of the industry.
The Consortium has the specific aims of:
- Developing an integrated database of aggregated control group trial data in standardized format;
- To submit biomarkers to the FDA for possible qualification;
- To submit quantitative models of disease progression to the FDA for possible qualification.
CAMD members will collaborate to gather and submit the evidence necessary for the FDA and EMEA to officially designate such tools as "qualified for use" in drug development. These newly qualified tools will be made publicly available for use by scientists and commercial developers alike.
The CAMD Consortium is split into four Workgroups: Alzheimer’s Disease (AD) Biomarkers Evaluation, Data, Disease Progression Modeling, and Health Authorities Submissions.
Prof. Hill will take part in the AD Biomarkers Evaluation Workgroup, which aims to establish a process and execute a plan for compiling and evaluating the scientific merit of reported biomarkers (including imaging data) that are potentially useful in drug or diagnostic test development.
Specific objectives are to:
- Establish a process for collating a comprehensive list of potential biomarkers using publicly available data and CAMD members’ proprietary data;
- Establish an evidence-based process incorporating current methods to assess scientific strength of candidate biomarkers;
- Determine which biomarkers should have priority for further development efforts, as well as specific use contacts;
- Determine when biomarkers have sufficient evidence to be submitted to the biomarker qualification process with FDA and EMEA;
- Integrate biomarker data into quantitative disease-progression models and use evolving disease models to help with the evaluation of biomarkers.
CAMD participants include the following:
- Alliance for Aging Research
- Alzheimer's Association
- Alzheimer's Foundation of America
- AstraZeneca Pharmaceuticals LP
- Bristol-Myers Squibb Company
- Daiichi Sankyo
- Eli Lilly and Company
- Forest Research Institute
- Genentech Inc.
- Johnson & Johnson
- National Health Council
- Novartis Pharmaceutical Corporation
- Parkinson's Action Network
- Parkinson's Disease Foundation
- Pfizer, Inc.
- Sanofi-Aventis, US, Inc.
- Wyeth Pharmaceuticals, Inc.
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