AGENDA

7:30 a.m. - 8:00 a.m.	Registration

8:00 a.m. - 8:05 a.m.	Welcome and Meeting Objectives

Session I	Perspectives for Pre-clinical Use of Beta Cells Intended for Clinical Investigation *Moderator:* Julia Greenstein, Juvenile Diabetes Foundation International (JDRF)

8:05 a.m. - 8:35 a.m.	In Vitro Methods for Evaluation and Characterization of Beta Cell Function Chris Rhodes, University of Chicago

8:35 a.m. - 9:05 a.m.	Regulatory Considerations for Manufacturing and Testing Beta Cells Caitilin Hamill, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)

9:05 a.m. - 9:35 a.m.	Pre-clinical Considerations for Islet Transplantation: An FDA Perspective Allen Wensky, CBER, FDA

9:35 a.m. - 10:05 a.m.	Humanized Mouse Models and Therapeutic Approaches for Studying T1D Dale Greiner, University of Massachusetts

10:05 a.m. - 10:35 a.m.	Panel Discussion

10:35 a.m. - 11:00 a.m.	Break

Session II	Preparing for Clinical Trials in T1D *Moderator:* David Harlan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

11:00 a.m. - 11:20 a.m.	Planning and Designing Clinical Trials in T1D: An FDA Perspective Bruce Schneider, CBER, FDA

11:20 a.m. - 12:05 p.m.	Practical Considerations and Case Study of Preparing a Novel Cell Therapy for Clinical Trials Bernhard Hering, University of Minnesota

12:05 p.m. - 12:30 p.m.	Panel Discussion

12:30 p.m. - 1:30 p.m.	Lunch Sponsored by JDRF

Session III	Transplantation Using Porcine Islets and Immune Barrier Materials *Moderators:* Keith Wonnacott, CBER, FDA and Michael Appel, NIDDK

1:30 p.m. - 1:55 p.m.	Husbandry and Safety Issues in Porcine Clinical Product Development Henk-Jan Schuurman, University of Minnesota

1:55 p.m. - 2:20 p.m.	Efficacy of Encapsulated and Transplanted Porcine Islets Robert Elliott, Living Cell Technologies

2:20 p.m. - 2:45 p.m.	Advances in Materials and Devices to Affect Delivery of Cell Therapy Elliot Chaikoff, Emory University

2:45 p.m. - 3:10 p.m.	Panel Discussion

3:10 p.m. - 3:30 p.m.	Break

Session IV	In Vitro Differentiated Human-Derived Cells for Treatment of T1D *Moderators:* Olivier Blondel, NIDDK, and Robert Goldstein, Juvenile Diabetes Research Foundation International (JDRF)

3:30 p.m. - 4:10 p.m.	Pancreatic Beta Cell Replacement Approaches Using Human Embryonic Stem Cells Ed Baetge, Novocell, Inc.

4:10 p.m. - 4:50 p.m.	Human Embryonic Stem Cell-Derived Islets Cellular Characterization Jackie Lee, Geron Corporation Pathway to the Clinic Thomas Okarma, Geron Corporation

4:50 p.m. - 5:10 p.m.	Panel Discussion Panel: TBD Moderator(s): TBD

5:30 p.m. - 7:30 p.m.	Networking Reception