Overview
Join Us in Accelerating New Treatments for PCOSPolycystic Ovary Syndrome
Externally-Led Patient-Focused
Drug Development Meeting
Presented by
About the Meeting Organizer
The PCOS Externally-Led Patient-Focused Drug-Development Meeting (PCOS EL-PFDD Meeting) was organized by PCOS Challenge: The National Polycystic Ovary Syndrome Association. Serving nearly 60,000 members, PCOS Challenge 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 efforts. PCOS Challenge provides support to industry partners at every stage of development, from initial discovery and preclinical phases to post-FDA approval and outcome assessment.
PCOS EL-PFDD Meeting Background
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 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.
Who Should Attend the PCOS EL-PFDD meeting?
The PCOS EL-PFDD meeting will be attended by PCOS patients, FDA and other regulatory/federal agency representatives, medical product developers, academic researchers, clinicians and healthcare professionals specializing in PCOS.
When
FRIDAY, NOVEMBER 3, 202310:00 AM – 2:30 PM ESTWhere
RIGGS ALUMNI CENTERCOLLEGE PARK,MARYLAND
Attend In-Person or Remotely
MEETING GOALS
UNDERSTANDING
To provide the FDA, medical product developers, the scientific community, and other stakeholders with a greater understanding of the experiences, perspectives, needs, and priorities of PCOS patients to support the development of FDA-approved treatments for PCOS.
CLARITY
Listen to patient voices as they describe the impact of living with PCOS to identify their priorities and goals for PCOS management and their experiences with current options for PCOS symptom management.
ACTIONABLE INSIGHTS
Consider endpoints and biomarkers for drug development trials and compare these with patient experiences to determine the clinical effectiveness of proposed treatments and align them with patient priorities.
Who Will Benefit from the PCOS EL-PFDD Meeting?
Patients and Caregivers
The PCOS EL-PFDD Meeting offers patients the opportunity to:
- Help shape and accelerate the development of new PCOS-focused treatments.
- Have their voices heard, directly informing the FDA and other stakeholders about the daily impacts and health effects of living with PCOS.
- Share their perspectives on the effectiveness of existing treatment and management options.
- Highlight their unmet needs and priorities for new treatments.
U.S. Food and Drug Administration (FDA)
The PCOS EL-PFDD Meeting and summary reports can aid FDA staff in:
- Acquiring patient insights for more informed benefit-risk evaluations of drugs, biologics, and devices under review.
- Advising drug sponsors on their development programs.
- Obtaining first-hand patient accounts of medication side effects, providing a nuanced understanding that can enhance post-market safety monitoring.
- Understanding what patients feel is lacking in current treatment options.
Industry and Pharmaceutical Companies
The PCOS EL-PFDD Meeting can help industry:
- Gain an in-depth understanding of patients’ experiences, symptom burden, and treatment history.
- Learn the multiple factors influencing patients’ treatment choices and trial participation.
- Identify unmet needs in PCOS care to drive more effective drug development.
- Obtain insights to design patient-centered clinical trials tailored to better meet the needs and priorities of PCOS patients.
- Foster important relationships needed for success in developing new PCOS therapies, diagnostics and devices. Patient and other stakeholder engagement is essential at all stages, ranging from initial discovery and preclinical phases to post-FDA approval and outcome assessment.
Researchers and Clinicians
The PCOS EL-PFDD Meeting can help researchers and clinicians:
- Better understand the lived experience of PCOS patients, enriching the context for clinical decisions and research directions.
- Gain insights from patients’ perspectives about the effectiveness, side effects, and other drawbacks of current treatment options, informing both research aims and clinical practice.
- Identify new research questions or gaps in existing knowledge, serving as a catalyst for innovative studies that can address unmet needs in PCOS care.
- Incorporate patient feedback to improve research and clinical processes and design.
- Enhance patient-provider communication by learning what information is most valuable to patients, improving patient satisfaction and treatment plan adherence.
PCOS PFDD MEETING - Register Now
Join us as we help shape and accelerate the future of treatment for polycystic ovary syndrome (PCOS).