Affecting the Aging Trajectory:
Regulatory Constructs for Gerotherapeutic Drug, Biologic & Device Development

Hybrid Public Meeting
Virtual or In Person at 1333 New Hampshire Ave., NW, Washington, DC 
May 27, 2026 | 10am-4pm (eastern)

Aging is the primary driver of virtually every major chronic disease, yet it remains largely absent from formal regulatory recognition as a therapeutic target. As researchers and product developers explore opportunities to improve the amount of time a person remains in good health and free from long-term disease or disability, identifying the appropriate regulatory construct is essential to shape research and regulatory review, assuring that interventions improve the public’s health.

On May 27, 2026, the Reagan-Udall Foundation for the FDA, in collaboration with ARPA-H and XPRIZE Foundation, will convene a hybrid public meeting on exploring regulatory constructs for gerotherapeutic drug, biologic and device development. Key topic areas include

  • discussing strategic use of Intrinsic Capacity (as defined by the WHO ICD-11 framework) and function-centered endpoints
  • building on established pediatric growth curve paradigm by exploring a standardized “Adult Health Curve” tracking intrinsic capacity
  • identifying functional features of aging, from midlife onward, as a serious medical condition
  • exploring the application of patient-relevant and regulatorily acceptable endpoints from other areas (such as pediatric neurodegenerative diseases) to improve health throughout the lifespan

In-person registration is currently full. Please register to attend virtually and email admin@reaganudall.org to be added to the in-person waitlist.

Register to Attend Virtually

Agenda

10am

Welcome & Opening Remarks

Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

Steven Kozlowski, MD, Chief Scientist, Office of the Chief Scientist, Office of the Commissioner, FDA

10:20am

The Healthspan Imperative: Geroscience, Federal and Private Sector Investment, and the Evidence Base

Presenters

  • James Appleby, BSPHARM, MPH, CEO, Gerontological Society of America
  • William Greene, MD, Chief Investment Officer, Hevolution Foundation
  • Jamie Justice, PhD, Executive Director, XPRIZE Healthspan, XPRIZE Foundation
  • Andrew Brack, PhD, Program Manager, PROactive Health Office, ARPA-H

10:45am

Landmark Evidence: What Aging Trials Have Taught Us About Endpoints, Populations, and Feasibility

Presenters

  • Nir Barzilai, MD, Director, Institute for Aging Research, Albert Einstein College of Medicine, President of the Academy of Geroscience
  • Stephen Kritchevsky, PhD, Professor, Gerontology and Geriatrics Internal Medicine, Wake Forrest University School of Medicine
  • Joan Mannick, MD, Chief Medical Officer, Altos Labs
  • Eric Morgen, MD, MPH, FRCPC, Chief Operating Officer, BioAge Labs

11:30am

Toward Regulatory Constructs: Intrinsic Capacity, Adult Health Curves, and Multi-Domain Endpoints

Presenters

  • David B. Allison, PhD, Chief of Nutrition and Director, USDA Children's Nutrition Research Center, Baylor College of Medicine
  • John Beard, MBBS, PhD, Irene Diamond Professor, Columbia University Mailman School of Public Health
  • Kelly Anderson, PhD, Scientific Engineering and Technical Advisor, ARPA-H
  • Nicholas Schork, PhD, Director, Quantitative Medicine and Systems Biology, HonorHealth Research Institute

12:15pm

Lunch

1:05pm

XPRIZE Healthspan and PROSPR Awardees: Evidence Being Built at Scale

Introductions by Justice and Brack

XPRIZE Healthspan Presenters

  • David A. Brown, PhD, Chief Scientific Officer, Stealth BioTherapeutics
  • Zahi A. Fayad, PhD, Lucy G. Moses Professor of Medical Imaging and Bioengineering, Icahn School of Medicine, Mount Sinai
  • Blake Rasmussen, PhD, Professor and Chair, UT San Antonio Long School of Medicine

ARPA-H PROSPR Presenters

  • Brianna Stubbs, PhD, Director of Translational Science, Buck Institute of Research on Aging
  • James Peyer, PhD, Founder and CEO, Cambrian Bio
  • George A. Kuchel, MD, CM, FRCP, Director, UConn Center on Aging, University of Connecticut

2:05pm

Regulatory Landscape: What Pathways Exist, Where They Break Down, and What Constructs are Needed

Panelists

  • Sandra Kweder, MD, Principal, Drug and Biological Sciences, Eliquent
  • G. Alexander (Zan) Fleming, MD, President, Kitalys Institute

2:25pm

Industry Perspectives: What Product Sponsors Need from FDA to Bring Gerotherapeutics to Market

Panelists

  • Joshua Diamond, MD, MSCE, Medical Director Clinical Development, Respiratory Early Pipeline Unit, GSK
  • David Glass, MD, Vice President, Research, Aging/Age-Related Disorders, Regeneron
  • Jill Lee, JD, Senior Director, Regulatory Policy and Intelligence, Novo Nordisk
  • Cindy Lawley, PhD, Senior Director, Population Health and Scientific Strategy, Olink, part of Thermo Fisher Scientific

3:05pm

Next Steps to Designing Workable Regulatory Constructs for Gerotherapeutics

Panelists

  • Andrew Brack, PhD, Program Manager, PROactive Health Office, ARPA-H
  • G. Alexander (Zan) Fleming, MD, President, Kitalys Institute
  • Jamie Justice, PhD, Executive Director, XPRIZE Healthspan, XPRIZE Foundation
  • Jill Lee, JD, Senior Director, Regulatory Policy and Intelligence, Novo Nordisk
  • Justin Penzenstadler, PharmD, Lead Clinical Analyst, Division of Diabetes, Lipid Disorders, and Obesity, Office of Cardiology, Hematology, Endocrinology, and Nephrology, Office of New Drugs, CDER, FDA (Invited)
  • Jeffrey Siegel, MD, Office Director, Office of Drug Evaluation Sciences, Office of New Drugs, CDER, FDA (Invited)
  • Lisa Yanoff, MD, Deputy Director, Office of Cardiology, Hematology, Endocrinology, and Nephrology, Office of New Drugs, CDER, FDA

3:55pm

Closing Remarks

Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

4pm

Adjourn

ARPA-H and XPRIZE Foundation provided funding for this meeting.