**Food and Drug Administration**

**Center for Biologics Evaluation and Research**

**BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE**

# Meeting \# 36 

**Holiday Inn, Gaithersburg, MD**

**October 9-10, 2003**

**AGENDA**

**[Thursday October 9, 2003]{.underline}**

**Session 1: Allogeneic Islet Transplantation**

**8:00 a.m.** Opening and Introduction of Committee

> Dr. Mahendra Rao, Acting Chair, BRMAC

**8:10** Conflict of Interest Meeting Statement Gail Dapolito, Executive
Secretary, BRMAC

**8:15** FDA Introduction

> Dr. Philip Noguchi
>
> Acting Director, Office of Cellular, Tissue and Gene Therapies (OCTGT)
>
> Center for Biologics Evaluation and Research, FDA

Dr. Jesse Goodman

Director

> Center for Biologics Evaluation and Research, FDA

[Federal Oversight of Allogeneic Islet Transplantation]{.underline}

**8:35** Overview of FDA Regulatory Issues

> Dr. Darin Weber
>
> Chief, Cell Therapy Branch, Division of Cellular and Gene Therapies
> (DCGT)
>
> Center for Biologics Evaluation and Research, FDA
>
> **8:45** HRSA's Role in Pancreas and Islet Transplantation
>
> Dr. Jim Burdick
>
> > Director, Division of Transplantation
>
> > Office of Special Programs
>
> Health Resources and Services Administration

**9:05** [Moving from Investigational Islet Products to Licensed Islet
Products]{.underline}

> Expectations for Facilities & cGMPs
>
> Dr. Nicholas Obiri
>
> Microbiologist, Division of Compliance and Biologics Quality
>
> Center for Biologics Evaluation and Research, FDA

**9:25** Processing and Product Quality Issues, Assessing the Final
Product

> Dr. Keith Wonnacott
>
> Microbiologist, Cell Therapy Branch, DCGT
>
> Center for Biologics Evaluation and Research, FDA

**9:45** Q&A

**10:05 a.m.** Break

F**DA Biological Response Modifiers Advisory Committee**

**Meeting #36**

**October 9-10, 2003**

**AGENDA (cont'd)**

**[Thursday October 9, 2003]{.underline}**

> > **Session 1: Allogeneic Islet Transplantation (Cont'd)**
>
> **10:20 a.m.** FDA Introduction to Guest Presentations Dr. Darin Weber
>
> Chief, Cell Therapy Branch, DCGT
>
> Center for Biologics Evaluation and Research, FDA
>
> **10:30** Islet Processing: Evolution and Current Standards
>
> Dr. Camillo Ricordi
>
> Professor of Surgery, Department of Surgery
>
> University of Miami
>
> **10:55** Q&A

**11:10** Current Status of Islet Characterization and Quality

> Dr. Bernhard Hering
>
> Associate Professor of Surgery, Department of Surgery
>
> University of Minnesota

**11:35** Q&A

**11:50** Open Public Hearing

**12:20 p.m.** Lunch

**1:30** Committee Discussion of Questions

**3:00** Break

**3:15** Committee Discussion of Questions (cont'd)

> **Session 2: Update of Research Programs in the Division of Cellular
> and Gene Therapies**
>
> **and the Division of Therapeutic Proteins**

**4:15** Introduction -- Laboratory of Stem Cell Biology and Laboratory
of Immunology and Virology,

> Division of Cellular and Gene Therapies, Office of Cellular, Tissue
> and Gene Therapies

Dr. Raj Puri

Acting Director, DCGT, OCTGT

Center for Biologics Evaluation and Research

Laboratory of Immunology and Virology

**4:20** Dr. Carolyn Wilson

Senior Investigator, Laboratory of Immunology and Virology (LIV), DCGT

**4:30** Dr. Andrew Byrnes

Senior Staff Fellow, LIV, DCGT

**4:35 p.m.** Dr. Nancy Markovitz

Senior Staff Fellow, LIV, DCGT

**FDA Biological Response Modifiers Advisory Committee**

**Meeting #36**

**October 9-10, 2003**

**AGENDA (cont'd)**

**[Thursday October 9, 2003]{.underline}**

> **Session 2: Update of Research Programs in the Division of Cellular
> and Gene Therapies**
>
> **and the Division of Therapeutic Proteins**

**4:40 p.m.** Laboratory of Stem Cell Biology

Dr. Steven Bauer

Acting Chief, Laboratory of Stem Cell Biology, DCGT

Center for Biologics Evaluation and Research, FDA

**4:45** Introduction -- Laboratory of Biochemistry, Division of
Therapeutic Proteins,

> Office of Biotechnology Products

Dr. Amy Rosenberg

Director, Division of Therapeutic Proteins

Office of Biotechnology Products

Center for Drugs Evaluation and Research, FDA

**4:50** Laboratory of Biochemistry

Dr. Emily Shacter

Chief, Laboratory of Biochemistry

**4:55** Break

**Closed Session**

**5:50 p.m.** Adjourn

**FDA Biological Response Modifiers Advisory Committee**

**Meeting #36**

**October 9-10, 2003**

**AGENDA (cont'd)**

**[Friday October 10, 2003]{.underline}**

**8:00 a.m.** Opening/Administrative Remarks

Dr. Mahendra Rao, Acting Chair, BRMAC

**8:10** FDA Introduction

Dr. Cynthia Rask

> Director, Division of Clinical Evaluation and
>
> Pharmacology/Toxicology, OCTGT
>
> Center for Biologics Evaluation and Research, FDA

**8:25** Current Status of Clinical Islet Transplantation Dr. James
Shapiro

> Clinical Research Chair in Transplantation
>
> University of Alberta, Canada

**8:50** Q&A

**9:05** Allocation of Pancreata for Whole Organ and Islet
Transplantation

Dr. Jim Burdick

> Director, Division of Transplantation, HRSA

**9:25** Q&A

**9:40** Ethical Considerations in Allogeneic Islet Transplantation

> Dr. James Childress
>
> John Allen Hollingsworth Professor of Medicine
>
> University of Virginia

**10:05** Q&A

**10:20** Clinical Development of Islet Products

> Dr. Dwaine Rieves
>
> Medical Officer, Division of Clinical Evaluation and
>
> Pharmacology/Toxicology, OCTGT
>
> Center for Biologics Evaluation and Research, FDA

**10:45** Q&A

**11:00** Open Public Hearing

**11:30** Lunch

**12:00 noon** Committee Discussion of Questions

**2:00 p.m**. Adjourn