[CarolynS]

There's still time to register for PAN's Webcast and hear from experts about how the Food & Drug Administration's work Impacts the Parkinson's Community.


Join the Parkinson's Action Network and viewers across the country for a live, educational webcast and learn why the Food and Drug Administration is important to the Parkinson's community! This informative webcast provides a unique opportunity to gain valuable insights into the FDA, the role it plays in therapy development, and possible areas for needed change and improvement.

When...TODAY: Monday, December 12
3 – 4:30 p.m. EST

Where: Click here to register online to view the webcast and submit questions for discussion by our panelists. Can’t join us this afternoon? The webcast will be archived online for future viewing!

Moderator:
Amy Comstock Rick, JD
CEO, Parkinson's Action Network

Panelists:
Marc Walton, MD, PhD
Associate Director for Translational Medicine in the Office of Translational Sciences at the Center for Drug Evaluation and Research, FDA

Michelle McMurry-Heath, MD,PhD
Associate Director for Science at the Center for Devices and Radiological Health, FDA

Cartier Esham, PhD
Senior Director of Emerging Companies Health and Regulatory Affairs for the Biotechnology Industry Organization (BIO)

Jackie Christensen
Patient-Representative to the Food and Drug Administration's Office of Special Health Issues

This program is made possible by a conference support grant awarded from and administered by the Telemedicine & Advanced Technology Research Center (TATRC) of the U.S. Army Medical Research & Materiel Command (USAMRMC), Award # W23RYX1067N603

[Conductor71]

Just logged off. Sadly this was just a waste of time. They spent an hour blathering on about nothing and gave a non-answer to the pointed question on Duodopa.

Laura

[GregD]

I am trying to find a flow chart that was given to me. It shows the process, timelines and costs of how a drug progresses through the system including the FDA. It had a lot of useful information on it. I will make it a pdf file and post it, if I can ever locate it again.

[Perryc]

I am sorry I missed this presentation, but I was out purchasing a car to replace my 1996 SUV, which which had given out like its owner Dx in 1996.

For those who dont know me, I was PD patient representative on the FDA Advisory Committee on DBS in 2000. Since then, I have received information and training from the FDA, Office for Special Health Initiatives (OSHI) on an on-going basis and I have collaborated with OSHI to provide on-going information and support for PD advocates on what PD patients' interests are versus other constituents (industry, scientists, regulators) whose interests overlap with the patients interests.

I realized at that time that the exclusive focus of the PD advocacy community on scientific research at NIH and elsewhere (e.g. DOD-NETREP)was only part of the solution. What the scientists didnt tell us was that after a discovery from basic research, it may take 15 to 20 years to get a new therapy on the market. In fact other than DBS which provides a great relief from symptoms for many, there have been only marginal improvements in treatment options for 40 years since Sinemet was approved.

PWP who have been leaders on this forum helped me form a grass roots network of PD advocates, the Parkinson pipeline project, which has lead the way on providing the patient perspective to decision makers in FDA, not just at advisory committees, but also in pre approval meetings between sponsors and regulators, at critical points in the lengthy and methodical process of approval. These meetings before were totally secret proprietary information owned by sponsors. Although we still have some problems to iron out, to maximize the influence of PWP on the regulatory processes, the changes in FDA toward more transparency and patient centered outcomes has been substantial.This has been a part of a larger paradigm shift from doctor/scientist centered research in the 20th century to a patient centered paradigm in the the 21st century. This patient centered approach is more suited to the unsolved health problems of continuity of care and integration of services that challenge our broken health care system and its inability to address the needs of healing from chronic disease. My recent efforts have focused on greater engagement with patients in activation and self help, so called information therapy supported by information technology to enhance individualized patient-provider interaction and choice. I have been working with the 'Working Group on Evidence Based Medicine ( a coalition of patient advocacy as well as PDF to expand the efforts of the pipeline project to inform patient advocates. I am glad to see that PAN is working on FDA issues because they are so important to us. I hope some people found the seminar to be valuable.

Perry

[Conductor71]

Appreciate all your work on our behalf. I am wondering why it takes eleven plus years for the FDA to "Fast Track" a treatment used for a decade in Europe. Why would it need meet both safety and efficacy trials all over again?

Laura

[jeanb]

Here is their contact info:

CDER - Office of Translational Sciences - Organization - Text version
The following header reflects the organizational hierarchy.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRANSLATIONAL SCIENCES



Main Tele: 301-796-2600
Fax: 301-796-9907

Marc Walton, MD, PhD
Associate Director for Translational Medicine
email: marc.walton@fda.hhs.gov

Address: WO Bldg 21 Rm: 4554
10903 New Hampshire Ave.
Silver Spring, MD 20993

I"m going to write to them (send a fax) and ask about Duodopa. A good treatment is being withheld from us.

Jean