SADS Externally-led Patient Focused Informational Webinar
June, 20, 2023
SADS Foundation is hosting an Externally-Led Patient Focused Drug Development (EL-PFDD) meeting on ARVC on June 20, 2023. This public meeting is extremely important for our community and is a once-in-a-lifetime opportunity for patients and families impacted by ARVC to speak directly to the U.S. Food and Drug Administration (FDA), medical product developers, clinicians, and academic researchers. The purpose of the meeting is to hear from as many people as possible that have been affected by ARVC.
This informational webinar on the EL-PFDD will provide an overview of the upcoming meeting.
Speakers:
Larry Bauer and James Valentine from Hyman, Phelps & McNamara
Larry worked at the NIH for 17 years in clinical research, followed by a position at the FDA as a Regulatory Scientist in the Center for Drug Evaluation and Research’s Rare Diseases Program, a group he co-founded and worked for 10 years, where he advanced rare disease drug development.
James has worked the last 13 years as a champion for the patient voice as part of the regulatory process. James previously worked at the FDA where he was a patient liaison, helping to incorporate the patient voice into medical product review across the FDA’s various medical product centers and review divisions. There, he helped to develop and launch the Patient-Focused Drug Development initiative.
In private practice, James and Larry have worked with many patient organizations to ensure their community’s voices were heard by decision-makers. Relevant to our EL-PFDD meeting, they has been involved in helping plan and moderating three-fourths of the over 75 externally-led PFDD meetings.
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