Peg FordFDA Patient Representative

Co-Founder/PresidentOvarian Cancer Alliance of San Diego

How Did I End Up Here?

“Dare to stand beforethose you fear and speakyour mind, even ifyour voice shakes.”Maggie Kuhn, Social Activist and Founder of the Gray Panthers

PREPARATION for FDA Patient Representative

American Association for Cancer Research (AACR) Scientist<>Survivor ProgramAmerican Society for Clinical Oncology (ASCO) Advocate Scholarship ProgramNational Breast Cancer Coalition (NBCC) Project LEAD (Innovative Science Program for Breast Cancer Activists)

FDA Patient Representative Training one-on-one training teleconferences Office of Health & Constituent Affairs Patient Representative Workshop

Three little words…

Location, location, location…Preparation, Preparation, Preparation

Preparing for the FDAAdvisory Committee Meetings:

• Time and Effort • Commitment • Responsibility

Patient Representative Review of Documents for an FDA Meeting (September 2010):

“Experience and expertise of a patient representative is most relevant with respect to weighing the value of a product’s benefits and risk.

Does the risks outweigh the benefits; what happened to the patients in the trial and who benefits and who is at a disadvantage and is this okay?

Greatest contribution is by advising FDA on issues that are fundamentally less technical and more focused on how the product and the plans of the manufacturer and FDA with respect to the product, relate to the needs and preferences of patients.”

These were the reminders to me, this had to be about the patient community. Not my personal opinion or any organization I am associated with, but the patient communityat large.

FDA Advisory Committee Meetings

Respond to scientific, technical or policy questions:• Is an unapproved product safe and effective?• Does the benefits outweigh the risks to patients?

Looking forward . . .• Preparing consumers/patients to be trained, informed

and involved participants will take a collaborative effort of cooperation and communication including financial funding.• Yes, there are challenges … one very important challenge

is how to reach, recruit and train patients from all ethnic and social-economic groups for their participation as their voices need to be heard and represented.

Thank You!On her 80th birthday, Maggie Kuhn made a vow to do something outrageous at least once a week. In her late eighties she increased it to at least once a day. “You get people’s attention that way. You get energized, you can make an impact, and it’s just fun,” she noted.

Maggie KuhnAugust 3, 1905 – April 22, 1995

Could not have said it better myself as I am zip-lining to my

70th birthday, and most often, I say, “How the heck did I end up here and that is certainly true today.”