Food and Drug Administration
Center for Biologics
Evaluation and Research
BIOLOGICAL RESPONSE
MODIFIERS ADVISORY COMMITTEE
Holiday Inn, Gaithersburg,
MD
October 9-10, 2003
AGENDA
Thursday
October 9, 2003
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
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
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
FDA Biological Response Modifiers Advisory Committee
Meeting #36
October 9-10, 2003
AGENDA (cont’d)
Thursday
October 9, 2003
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
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
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