2004N-0181 - Critical Path Initiative; Establishment of Docket
FDA Comment Number : EC29
Submitter : Dr. Perry D Cohen Date & Time: 08/02/2004 07:08:05
Organization : Parkinson Pipeline Project
Consumer Group
Category :
Issue Areas/Comments
GENERAL
GENERAL
On behalf of the Parkinson's pipeline project, I am submitting 2 items for consideration and as agenda items for the Critical Path Initiative (CPI). These two items address important aspects of the process for evaluation and approval of new therapies:
* The first is aimed at ensuring that the patient's perspective is incorporated explicitly into the process of new therapy approval.
* The second is a more technical issue to link to scientific research at the NIH and in the private sector in the areas of validated measures of clinical efficacy, and in particular surrogate biomarkers that can greatly reduce the time and costs for product development and evaluation.

The Parkinson's pipeline project (PPP) is a grassroots organization of people with Parkinson's Disease (PWP), who have joined forces to accelerate the introduction of improved therapies and combat Parkinson's disease. Drawing on my experience as a patient representative for Parkinson's at the FDA, I initiated the PPP three years ago to begin do what we can do as patients to facilitate the approval of treatments. We offer information and counsel to PWP and clinical researchers as well as to sponsors and the FDA, and we advocate for the "patient's perspective" during the evaluation process of therapy development. More information can be found at our web site: www.pdpipeline.org

Both of these documents are early drafts of the concepts that are expected to undergo further clarification and refinement over time. The Parkinson's pipeline project and other national organizations representing Parkinson's patients are eager to collaborate with the FDA, the NIH, and others on the development of these concepts into fully operational projects.