FasterCures, a center of the Milken Institute, designed this guide for patient advocacy organizations that are interested in hosting, or are currently planning, an externally led patient-focused drug development (PFDD) meeting. We have created other tools for planning PFDD meetings, including the PFDD Meeting Tracker, the PFDD Readiness Assessment, and the PFDD Community Toolbox. We recommend using this guide in concert with those tools and related resources from the US Food and Drug Administration (FDA).

The team at FasterCures conducted interviews with veteran hosts of externally led PFDD meetings to gather their insights. During the interviews, we found that many leaders shared a similar experience: while planning, they received guidance from those who had planned meetings before them. Organizations were willing to share advice, but the process wasn’t centralized or efficient. In response, we have taken what we heard from those leaders and synthesized our findings into this guide to provide common practices, lessons learned, and considerations for patient organizations that might host a PFDD meeting or who have already begun the planning process.