WASHINGTON, Sept. 18, 2023 /PRNewswire/ — Despite affecting up to 15% of women and a $15 billion annual economic burden in the U.S. alone, polycystic ovary syndrome (PCOS) has yet to see any treatments specifically for the disorder approved by the U.S. Food and Drug Administration (FDA). To address this critical gap in care, PCOS Challenge: The National Polycystic Ovary Syndrome Association has organized the PCOS Externally-Led Patient-Focused Drug-Development Meeting (PCOS EL-PFDD Meeting) as a listening session for the FDA, product developers, clinicians, and academic researchers to hear directly from individuals with PCOS about the health effects and daily impacts of the condition, their treatment goals, and their decision factors when seeking out or selecting a treatment. The PCOS EL-PFDD meeting is being conducted as a parallel effort to the FDA’s PFDD initiative to more systematically gather patients’ perspectives on their conditions and available therapies to treat their conditions. The input from EL-PFDD meetings can inform the FDA’s oversight during drug development and marketing application reviews.
The PCOS EL-PFDD Meeting will take place on Friday, November 3, 2023, from 10:00 AM to 2:30 PM EST at Samuel Riggs IV Alumni Center in College Park, Maryland. The event will be hybrid, enabling participation both in-person and via an interactive live stream.
What’s at Stake?
Sasha Ottey, Founder and Executive Director of PCOS Challenge, articulates, “This is a historic meeting in the field of PCOS that can have significant global impact. Decisions and precedents set by the FDA can have a profound influence on regulatory bodies worldwide. As we look forward to this important event, we are excited to engage with FDA representatives, researchers, clinicians and companies that are committed to understanding PCOS and recognize the indispensable advantages of putting patients’ needs and priorities at the center of care. Despite nearly 90 years since PCOS was first identified as Stein-Leventhal Syndrome, we still face the stark reality that there are no FDA-approved treatments specifically tailored for this condition. This meeting and our strategic follow-up efforts are designed to provide both the FDA and industry with invaluable patient insights. These efforts aim to accelerate the development of new FDA-approved therapies, diagnostics, devices and other technologies targeted for PCOS.”
Benefits for Patients Attending
Participating in this meeting grants patients the unprecedented opportunity to influence the development of PCOS-focused treatments. Benefits include:
- Directly informing stakeholders about the daily impacts and health effects of living with PCOS.
- Sharing perspectives on the effectiveness of existing treatment and management options.
- Highlighting patients’ unmet needs and priorities for new treatments.
Benefits for Industry Representatives and Healthcare Providers Attending
For industry stakeholders, attending this meeting is a strategic move toward patient-centered innovation. Benefits encompass:
- Gaining an in-depth understanding of patients’ experiences, symptom burden, and treatment history.
- Learning the multiple factors influencing patients’ treatment choices and trial participation.
- Identifying unmet needs in PCOS care to drive more effective drug development.
- Obtaining insights to design patient-centered clinical trials tailored to better meet the needs and priorities of PCOS patients.
For more information on the PCOS EL-PFDD Meeting, registration and sponsorship opportunities, visit https://pcoschallenge.org/pcos-pfdd.
About Polycystic Ovary Syndrome
PCOS is a serious genetic, hormone, metabolic, and reproductive disorder that can lead to lifelong complications, infertility, anxiety, depression and other psychosocial disorders, obesity, severe hair and skin issues, endometrial cancer, type 2 diabetes, cardiovascular disease, stroke, nonalcoholic fatty liver disease and other conditions.
About PCOS Challenge
Serving nearly 60,000 members, PCOS Challenge: The National Polycystic Ovary Syndrome Association is the largest PCOS patient advocacy organization globally. PCOS Challenge is the leading organization advancing PCOS health policy at the federal and state level, patient-centered research and patient-focused drug development and treatment options. PCOS Challenge provides support to industry partners at every stage of development, ranging from initial discovery and preclinical phases to post-FDA approval and outcome assessment.
William R. Patterson
Director of Public Affairs
PCOS Challenge: The National Polycystic Ovary Syndrome Association
SOURCE PCOS Challenge: The National Polycystic Ovary Syndrome Association