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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. – 10:00 a.m.
Q&A
10:00 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.
Selecting Nonclinical Models for Beta-Cell Replacement
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 as An Immunoprotection Strategy
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.
Session 3: Perspectives and Lived Experiences from People with
T1D
Moderator: Peter Senior, Ph.D., M.B.B.S., University of Alberta
Session 4: 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
Lihan Yan, Ph.D., CBER/FDA
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 5: Advancing Cell Therapies with Current and Emerging Digital
Twins and AI/ML Technologies
Moderators: Guillermo Arreaza-Rubín, M.D., NIDDK
Tom Bollenbach, Ph.D., ARMI
11:40 a.m. – 11:55 a.m.
Predicting Islet Transplant Outcomes Using Artificial Intelligence
Peter Jacobs, Ph.D., Oregon Health & Science University
11:55 a.m. – 12:10 p.m.
Advanced Manufacturing of T1D Cell Therapies
Mudassir Rashid, Ph.D., Illinois Institute of Technology
12:10 p.m. – 12:25 p.m.
Harnessing AI/ML and Synthetic Biology in the Design of Cell
Therapies
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
Adam Mendizabal, Ph.D., The Emmes Company
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.
Event Logistics
Registration
Registration Closed
Registration ended
Location
The Lister Hill Center (Building 38A) Bethesda,MD20894
