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Virtual Meeting on Gerotherapeutic Regulatory Pathways Open to GSA Members

James Appleby - CEO Blog

I’ve accepted an invitation to present on Wednesday, May 27, at “Affecting the Aging Trajectory: Regulatory Constructs for Gerotherapeutic Drug, Biologic & Device Development,” and I encourage GSA members to join us virtually!

Co-sponsored by XPRIZE Healthspan and ARPA-H's PROSPR program, this public meeting — convened by the Reagan-Udall Foundation for the FDA — will bring together FDA leadership, select awardees, academic researchers, product developers, clinicians, and patient advocates to address a fundamental gap: aging is the primary driver of virtually every major chronic disease, yet it remains largely absent from formal regulatory recognition as a therapeutic target.

Several GSA members will also be serving as panelists. You can join the program online from 10 a.m. to 4 p.m. ET on May 27. (The meeting will be held in Washington, DC, and in-person registration is currently full.)

The day will feature sessions on:

  • The geroscience evidence base and landmark aging trials
  • Intrinsic Capacity as a regulatory construct (WHO ICD-11 framework)
  • Multi-domain endpoints and the concept of an Adult Health Curve
  • XPRIZE Healthspan and ARPA-H PROSPR building evidence at scale
  • Industry perspectives on what FDA must provide for gerotherapeutics to reach market
  • Practical pathways toward workable regulatory constructs

Our aim is to advance conversations that could reshape how aging interventions are developed, evaluated, and approved. It’s an honor to be part of an event that sits at the intersection of regulatory science, research on aging, and the future of healthspan and longevity.

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