 |
 |
On route to the cure, what scientists didnt tell us when we passed the Udall Act in 1997 or even when the Parkinson's Research Agenda was established in 2000, it takes nearly 15 years on average from a new discovery to a treatement available to the public. This process is governed by the FDA in the USA. The Parkinson Pipeline Project (www.pdpipeline.org <http://www.pdpipeline.org>) was started to do what we can do a patients and advocates to accelerate that process. A key resource that we bring to the table is our first hand experience with this disease. For the past several years we have established a variety of consultative relationships with sponsors of new therapies to educate them about the symptoms and variations of the disease and advise on evaluation of new therapies from the patient perspecive. As a patient representative for PD at FDA, I proposed similar advice for the FDA has been on the table. This week the FDA announced "FDA's Patient Consultant Program will be expanded to include Parkinson's disease. The FDA Patient Consultant Program incorporates the perspective of patient advocates into drug development.... FDA will recruit, select, and train Parkinson's disease patient advocates for the Program. The selected patient advocates will serve as patient consultants primarily in the pre-approval, clinical trial phase of Parkinson's disease drug development. The patient consultants will provide advice to the FDA and to the drug sponsor on topics such as clinical trial design, endpoint determination, expanded-access protocol development, and clinical trial patient recruitment strategies. FDA will arrange for patient consultants to participate via telephone in FDA in-house meetings and meetings with sponsors. Information regarding how to apply, FDA's selection criteria and processes, training, and consulting is attached and is available from the FDA Office of Special Health Issues at http://www.fda.gov/oashi/cancer/pconback.html. For further information, please contact JoAnn Minor or David Banks at 301-827-4460. Perry ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn