FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE
AND GENE THERAPIES ADVISORY COMMITTEE
Meeting, #47, May 14-15, 2009
Hilton Hotel,
DRAFT AGENDA
May 14, 2009
Open Session
Topic I - Potential
for Chlamydia trachomatis and Neisseria gonorrhoeae transmission
by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that
are recovered from the reproductive system, gestational tissues, or other
sources
8:00 a.m. Welcome and Introduction of Members
Walter Urba, M.D., Ph.D., Acting Chair
Conflict of Interest Statement
Gail Dapolito, Designated Federal
Officer
8:10 FDA Introduction
Melissa Greenwald, M.D.
Office of Cellular, Tissue and
Gene Therapies (OCTGT)
Center for Biologics Evaluation
and Research (CBER)
Ana Kolin, Ph.D., OCTGT, CBER
8:45 Q&A
Guest Presentations
9:00 Epidemiology
and Infectivity of Chlamydia trachomatis
and Neisseria gonorrhoeae
John Papp, Ph.D.
Division of STD
Prevention
CDC
9:25 Q&A
9:35 Human Amniotic
Membrane: Current Scope of Manufacture
and Utilization
Scheffer C. G. Tseng,
M.D., Ph.D.
Bio-Tissue, Inc.
9:55 Q&A
10:10 Break
10:25 Current Screening and Testing Practices
for Donors of Cord Blood
John Miller, M.D.,
Ph.D.
National Marrow Donor Program
10:40 Q&A
10:50 Open Public Hearing
11:10 Committee Discussion of Questions
12:30 p.m. Adjourn Session
Lunch
FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE
AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #47, May
14-15, 2009
DRAFT AGENDA (Cont’d)
May 14, 2009
Open Session
Topic II - Animal
Models for Porcine Xenotransplantation Products Intended to Treat
Type 1 Diabetes or Acute
Liver Failure
1:30 p.m. Introduction
of Members
Conflict of Interest Statement
1:40 FDA Introduction
Mercedes Serabian, M.S., DABT
OCTGT,
CBER
1:55 Q&A
2:00 Open
Public Hearing
Guest
Presentation
2:20 Animal Models for
Evaluation of Porcine Cells/Tissues to Treat Patients with Acute Liver Failure
Ira Fox, M.D.
2:45 Q&A
2:55 Committee discussion of
questions
4:00 Break
Guest
Presentation
4:15 Animal Models for
Evaluation of Porcine Islet Products to Treat Patients with Type 1 Diabetes
Bernhard Hering, M.D.
4:40 Q&A
4:50 Committee
discussion of questions
6:00 p.m. Adjourn
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
CELLULAR,
TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #47,
May 14-15, 2009
DRAFT AGENDA (Cont’d)
May 15, 2009
Open Session
Topic III - Clinical issues related to the FDA draft guidance
“Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee
Cartilage”
8:00 Welcome and Introduction of Committee
Conflict
of Interest Statement
8:10 Recognition of Committee Service
8:20 Update:
Guidance Documents from the Office of Cellular, Tissue and Gene
Therapies, Center for Biologics Evaluation
and Research, and the Center for
Veterinary Medicine
Richard McFarland,
Ph.D., M.D., OCTGT, CBER
8:30 FDA Introduction to Topic III
Richard
McFarland, Ph.D., M.D.
Guest Presentations
8:40 An
Overview of Treatment Options for Articular Cartilage Repair:
Past,
Present and Future
Kenneth Zaslav,
Sports Medicine and
9:10 Q&A
9:25 Issues
Concerning Clinical Outcomes in Long-Term Trials of Cellular Therapies for
Cartilage Repair
Gunnar Knutsen, M.D.,
9:55 Q&A
10:10 Open Public Hearing
10:30 Break
11:00 Committee Discussion of Questions
1:00 p.m. Adjourn