On September 3, 2015, Ovarian cancer survivors and FDA Patient Representatives Peg Ford, Susan Leighton and Annie Ellis were invited to provide the patient perspective at the recent Ovarian Cancer Endpoints Workshop hosted by the Food and Drug Administration (FDA).  This meeting was co-sponsored by the Society of Gynecologic Oncology (SGO), the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO).   Many important topics to the ovarian cancer community were discussed, including novel clinical trial designs, biomarkers, and new classes of agents such as immunotherapies.

1. Peg Ford
FDA Patient Representative
Co-Founder/President
Ovarian Cancer Alliance of San Diego
How Did I End Up Here?

2. “Dare to stand before
those you fear and speak
your mind, even if
your voice shakes.”
Maggie Kuhn, Social Activist and
Founder of the Gray Panthers

3. PREPARATION for FDA Patient Representative
American Association for Cancer Research (AACR)
Scientist<>Survivor Program
American Society for Clinical Oncology (ASCO)
Advocate Scholarship Program
National 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

4. Three little words…
Location, location, location…
Preparation, Preparation, Preparation
Preparing for the FDA
Advisory Committee Meetings:
• Time and Effort
• Commitment
• Responsibility

5. 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 community
at large.

6. 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?

7. 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.

8. 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 Kuhn
August 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.”