On April 25th, 2023, FDA is hosting a virtual public meeting on Patient-Focused Drug Development (PFDD) for Long Covid. This meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long Covid, including how Long Covid affects their daily life, the symptoms that matter most to patients, their current approaches to treating Long Covid, and what they consider when determining whether or not to participate in a clinical trial. This is a unique opportunity to share stories of living with Long Covid, as well as experiences with treatments, with important decision-makers at the FDA.
The hoped-for outcome of the meeting is to improve the development of new drugs in the research pipeline and inform the context in which regulatory decisions will be made for new drugs for Long Covid.
To help community advocates prepare for this unique and important meeting, Solve invited two former FDA officials who are experts in this area to share tips
Though Solve is not involved in the planning of the PFDD meeting, we have invited two former FDA officials who are experts in this area to help prepare our community for this important day.
- James Valentine, JD, MHS, has worked the last 15 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.
- Larry Bauer, RN, MS, 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. 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 the upcoming PFDD meeting, both Larry and James were involved in these FDA-led PFDD meetings in their time at the Agency, and since leaving have been a resource to the majority of patient communities participating in FDA’s sister externally-led PFDD program.
This webinar covered the following topics:
- Background on FDA & Drug Development
- Introduction to Patient-Focused Drug Development & Role of Patient Voice
- Overview of the PFDD Meeting
- Guide to Participating in the Meeting
- Logistics, Format, & Tips
