Event Details
Agenda
Travel
Event Details
See Important Visitor Information below regarding an earlier registration deadline for foreign visitors.
Meeting Resources
Purpose
This public workshop aims to bring together relevant stakeholders to discuss best practices and recommendations to foster the translation of the next generation of cell replacement therapies for type 1 diabetes (T1D). The meeting will include panel discussions and presentations of lessons learned on challenges and strategies specific to the clinical, nonclinical and manufacturing/quality needs to advance future T1D cell replacement therapies.
Planning Committee
| Name |
Affiliation |
Title |
| Guillermo Arreaza-Rubín |
NIDDK |
Program Director, Division of Diabetes, Endocrinology, & Metabolic Diseases |
| Thomas Bollenbach |
Advanced Regenerative Manufacturing Institute |
Chief Technology Officer |
| Kevin D’Amour |
Independent Consultant |
|
| Thomas Eggerman |
NIDDK |
Program Director, Division of Diabetes, Endocrinology, & Metabolic Diseases |
| Ellen Feigal |
NDA Partners |
Partner |
| Albert Hwa |
NIDDK |
Program Director, Division of Diabetes, Endocrinology, & Metabolic Diseases |
| Norma Kenyon |
University of Miami |
Martin Kleiman Professor of Surgery, Microbiology & Immunology, Biomedical Engineering and Biochemistry & Molecular Biology at the Diabetes Research Institute |
| Esther Latres |
Breakthrough T1D |
Senior Vice President, Research |
| Nicholas Mamrak |
Breakthrough T1D |
Senior Scientist, Research |
| Marjana Marinac |
Breakthrough T1D |
Associate Vice President, Regulatory Affairs |
| Chanel Press |
Breakthrough T1D |
Director, Regulatory Affairs |
| Michael Rickels |
University of Pennsylvania |
Professor in Diabetes and Metabolic Diseases |
| Katherine Szarama |
U.S. Food and Drug Administration |
Deputy Center Director, Center for Biologics Evaluation and Research |
Registration Deadline
September 14, 2026
Important Visitor Information
Due to recent changes to the campus access policy, participants who do not have U.S. Citizenship or Lawful Permanent Resident (Green Card holder) status will need to complete the VisitNIH pre-registration process at least 30 days but no more than 60 days before the start of the event. To avoid missing this deadline, please register for the workshop using the link above as soon as possible and indicate your status. If VisitNIH pre-registration is required, a staff member will reach out to help you through the process.
Agenda
Day 1: Tuesday, September 22, 2026
- 8:30 a.m. – 9:00 a.m.
- Arrival/Check-In
- 9:00 a.m. – 9:20 a.m.
- Opening Remarks
Lynn Starr, J.D., Breakthrough T1D
Griffin P. Rodgers, M.D., MACP, NIDDK
Megha Kaushal, M.D., M.Sc., Center for Biologics Evaluation and Research (CBER)/U.S. Food and Drug Administration (FDA)
- 9:20 a.m. – 9:50 a.m.
- Keynote Address
Timothy Kieffer, Ph.D., University of British Columbia
- 9:50 a.m. – 10:10 a.m.
- Q&A
- 10:10 a.m. – 10:20 a.m.
- Coffee Break
- 10:20 a.m. – 12:40 p.m.
- Session 1: Strategies in Nonclinical Studies for Type 1 Diabetes (T1D) Cell-Replacement Therapies
Moderator: Kevin D’Amour, Ph.D., Independent Consultant
- 10:20 a.m. – 10:40 a.m.
- Nonclinical Regulatory Considerations for Cell-Replacement Therapies
Yuan Rui, Ph.D., CBER/FDA
- 10:40 a.m. – 11:00 a.m.
- Strategies in Selecting Appropriate Nonclinical Models for Testing Beta-Cell Transplants
Melanie Graham, Ph.D., M.P.H., University of Minnesota
- 11:00 a.m. – 11:20 a.m.
- Immune Evasion of Cells
Dhaval Patel, M.D., Ph.D., Sana Biotechnology
- 11:20 a.m. – 11:40 a.m.
- Encapsulation
Alessandro Grattoni, Ph.D., Continuity Biosciences
- 11:40 a.m. – 12:25 p.m.
- Panel Discussion
Yuan Rui, Ph.D., CBER/FDA
Melanie Graham, Ph.D., M.P.H., University of Minnesota
Dhaval Patel, M.D., Ph.D., Sana Biotechnology
Tobias Deuse, M.D., University of California, San Francisco (UCSF)
Qizhi Tang, Ph.D., UCSF
Omid Veiseh, Ph.D., Rice University
Michael Brehm, Ph.D., University of Massachusetts
Kevin D’Amour, Ph.D., Independent Consultant
- 12:25 p.m. – 12:40 p.m.
- Q&A
- 12:40 p.m. – 1:50 p.m.
- Lunch Break
- 1:50 p.m. – 3:50 p.m.
- Session 2: Challenges and Opportunities in Manufacturing Cell-Replacement Therapies
Moderator: Tom Bollenbach, Ph.D., Advanced Regenerative Manufacturing Institute (ARMI)
- 1:50 p.m. – 2:10 p.m.
- Early-Stage Chemistry, Manufacturing, and Controls (CMC) Considerations for Cell-Replacement Therapies
Steven Oh, Ph.D., CBER/FDA
- 2:10 p.m. – 2:30 p.m.
- Challenges in Process and Analytical Development of Cell Therapies: An Academic Perspective
Cristina Nostro, Ph.D., University of Toronto
- 2:30 p.m. – 2:50 p.m.
- Industry Perspective on Large-Scale Manufacture of Cell-Replacement Therapies
Greg Russotti, Ph.D., Century Therapeutics, Inc.
- 2:50 p.m. – 3:35 p.m.
- Panel Discussion
Steven Oh, Ph.D., CBER/FDA
Cristina Nostro, Ph.D., University of Toronto
Greg Russotti, Ph.D., Century Therapeutics, Inc.
Jeffrey Millman, Ph.D., Washington University in St. Louis
Michael Scott, Ph.D., M.S., Aspect Biosystems
Dhruv Sareen, Ph.D., Cedars-Sinai Health Sciences University
James McGarrigle, Ph.D., CellTrans
Tom Bollenbach, Ph.D., ARMI
- 3:35 p.m. – 3:50 p.m.
- Q&A
- 3:50 p.m. – 4:00 p.m.
- Day 1 Wrap-Up/Summary
- 4:00 p.m.
- Adjourn
Day 2: Wednesday, September 23, 2026
- 7:45 a.m. – 8:00 a.m.
- Arrival/Check-In
- 8:00 a.m. – 8:05 a.m.
- Opening Remarks
- 8:05 a.m. – 9:05 a.m.
- Perspectives and Lived Experiences from People with T1D
Moderators: Peter Senior, Ph.D., M.B.B.S., University of Alberta
Marjana Marinac, Pharm.D., Breakthrough T1D
Panelists
Jeannette Hacker-Stratton
Dave Thoen
Alecia Wesner
Brittany Verras, M.P.H.
Allyson Hadland
- 9:05 a.m. – 11:25 a.m.
- Session 3: Clinical Trial Design Considerations for the Next-Generation Therapies
Moderator: Michael Rickels, M.D., M.S., University of Pennsylvania
- 9:05 a.m. – 9:25 a.m.
- Clinical Trial Design Considerations for Cell-Replacement Therapies
Rosa Sherafat, M.D., CBER/FDA
- 9:25 a.m. – 9:45 a.m.
- Early-Phase Trials of Cell-Replacement Therapies: Lessons Learned
Trevor Reichman, M.D., FRCSC, University of Toronto
- 9:45 a.m. – 10:05 a.m.
- Industry Experience: Lessons Learned from Translating from Bench to Clinic
Felicia Pagliuca, Ph.D., Vertex Pharmaceuticals
- 10:05 a.m. – 10:50 a.m.
- Panel Discussion
Rosa Sherafat, M.D., CBER/FDA
Trevor Reichman, M.D., FRCSC, University of Toronto
Felicia Pagliuca, Ph.D., Vertex Pharmaceuticals
Jason Gaglia, M.D., Joslin Diabetes Center
Timothy Kieffer, Ph.D., University of British Columbia
Michael Rickels, M.D., M.S., University of Pennsylvania
- 10:50 a.m. – 11:05 a.m.
- Q&A
- 11:05 a.m. – 11:40 a.m.
- Coffee Break
- 11:40 a.m. – 1:10 p.m.
- Session 4: Collaborations in an Artificial Intelligence (AI)–Powered Big Data Era
Opportunities for Partnerships in Pre-Competitive Space to Overcome Common Challenges
Moderators: Guillermo Arreaza-Rubín, M.D., NIDDK
Tom Bollenbach, Ph.D., ARMI
- 11:40 a.m. – 11:55 a.m.
- Use of Data Science/AI for Transplant Outcome Prediction
Peter Jacobs, Ph.D., Oregon Health & Science University
- 11:55 a.m. – 12:10 p.m.
- AI/Machine Learning Application to CMC
Mudassir Rashid, Ph.D., Illinois Institute of Technology
- 12:10 p.m. – 12:25 p.m.
- AI-Guided Understanding Stem Cell–Derived Islet Maturation
Wendell Lim, Ph.D., UCSF
- 12:25 p.m. – 1:00 p.m.
- Panel Discussion
Peter Jacobs, Ph.D., Oregon Health & Science University
Mudassir Rashid, Ph.D., Illinois Institute of Technology
Wendell Lim, Ph.D., UCSF
Boris Kovatchev, Ph.D., University of Virginia
Lihan Yan, Ph.D., CBER/FDA
Guillermo Arreaza-Rubin, M.D., NIDDK
Tom Bollenbach, Ph.D., ARMI
- 1:00 p.m. – 1:15 p.m.
- Q&A
- 1:15 p.m.
- Summary and Closing Remarks
Please note: Invited speakers and panelists are subject to change as we await confirmation of their attendance.
Travel
A hotel block with a negotiated room rate has been established by meeting co-organizer Breakthrough T1D. Breakthrough T1D will coordinate reservations with the hotel; however, attendees will be responsible for their individual room charges. If you would like to reserve a room within the workshop hotel block, please use the following link: https://cvent.me/ZmD9Kn.
