Wednesday, September 26, 2007
Introduction to the Regulation of Cellular Therapy
CBER/OCGT Update
Celia Witten, MD, PhD
Director, OCTGT, CBER, FDA
Introduction to Cell Therapy Regulations
Ellen Lazarus, MD
OCTGT, CBER, FDA
Regulatory Perspective on the Development of Manufacturing Processes
Keith Wonnacott, PhD
OCTGT, CBER, FDA
Donor Issues
Update on Donor Issues
Melissa Greenwald, MD
OCTGT, CBER, FDA
Donor Screening Challenges for Cord Blood Products
John Miller, MD
National Marrow Donor Program
Tissue Donor Testing and Screening Issues
Scott Brubaker, CTBS
American Association of Tissue Banks
Decision Analysis for Screening of HCT/P Donors
Brian Custer, PhD, MPH
Blood Systems Research Institute
Novel Therapies I
Regulatory Challenges for The Development of Allogeneic Mesenchymal Stem Cell Product
Rod Monroy, PhD
Osiris Therapeutics, Inc.
Application of Zinc Finger Nuclease Gene Disruption Technology to Manufacture Genetically Modified T cells for HIV Therapy
Bruce Levine, PhD
University of Pennsylvania
PEG Encapsulated Islets for the Treatment of Diabetes
*Presentation not available*
Xiaojie Yu, PhD
Novocell Inc.
Use of Devices in Manufacturing Cell Therapy Products
Introduction
Ellen Areman, MS, SBB(ASCP)
Biologics Consulting Group, Inc.
CBER Regulation of Devices for Cell Therapy
Richard McFarland, MD, PhD
OCTGT, CBER, FDA
IDE Submissions for Devices Used to Manufacture Cell Therapy Products
Janice Davis-Sproul, MAS, MT(ASCP)SBB
Johns Hopkins Medicine
Use of Automated Separation Devices for Cord Blood Processing
Safa Karandish, MT(ASCP)
MD Anderson Cancer Center
Technical and Regulatory Considerations for Use of a Bioreactor in Clinical Cell Manufacturing Under an IND
Bruce Levine, PhD
University of Pennsylvania
Thursday, September 27, 2007
Use of Banked Cells in Manufacturing Cell Therapy Products
Cell Banking: Issues and Guidance
Brenton McCright, PhD
OCTGT, CBER, FDA
Banking of Transformed B-cell line (TM-LCL)
Shelly Heimfeld, PhD
Fred Hutchinson Cancer Research Center
Banking Human Neural Stem Cells for Clinical Applications
Lisa Fox, MS, MT(ASCP)
Stem Cells, Inc.
Characterization of Human Embryonic Cell Banks for the Production of Cell Based Therapies
Jane Lebkowski, PhD
Geron Corporation
Novel Therapies II
Enhancing the Autologous and Allogeneic Anti-tumor effects of adoptive NK cell infusions
Richard Childs, MD
NIH/NHLBI
Prevention and Treatment of Viral Infections after HLA mismatch or unrelated Allogeneic Stem Cell Transplantation with Multivirus-specific cytotoxic T Lymphocytes
Catherine Bollard, MD
Baylor College of Medicine
Unmet Medical Needs in Ophthalmology
William Tente, MSc
Update on FDA Liaison Meetings
Kurt Gunter, MD
Update on CMS Reimbursement for Cell Therapy Products
James Gajewski, MD
Facility & Operational Issues for Cell Therapy Facilities
CGMP Considerations for Cell Therapy Products Under IND
Laurie Norwood, MSc
OCBQ, CBER, FDA
Environmental Monitoring Approaches in Cell Therapy Product Manufacturing
Angela Ondo, MT(ASCP)
Johns Hopkins Medicine
Media Fill Evaluations in Cellular Therapy Product Manufacturing: Three Possible Approaches
Doug Padley, MT(ASCP)
Mayo Foundation
Cleaning and Sanitization Strategies for Clinical Cell Therapies
Robert Preti, PhD
Progenitor Cell Therapy, LLC
Facility & Operational Issues for Cord Blood Banks
Cord Blood Processing Facility Challenges- what does cGMP mean?
Mary Malarkey, BSc
Director, OCBQ, CBER, FDA
GMP Challenges for Cord Blood Banks
Donna Regan, MT(ASCP)SBB
Cardinal Glennon Children's Medical Center
Issues of a large multi-national cord blood bank for the FDA Draft Guidance
Robert Chow, MD
StemCyte, Inc.
Combination Products
Regulation of Combination Products
Kimberly Benton, PhD
OCTGT, CBER, FDA
Combination Products - Development of an Autologous Neo-Bladder Construct
Tim Bertram, DVM, PhD
Tengion Inc.
Validation of a Combination Product for Treating Cardiac Disease
John McMannis, PhD
MD Anderson Cancer Center
Friday, September 28, 2007
Product Characterization & Stability
Assay Validation
Overview of Assay Validation
Thomas Finn, PhD
OCTGT, FDA
Microbiological Testing
Sterility testing of 361 and early phase 351 cell therapy products in an academic center
Hanh Khuu, MD
National Institute of Health
Validation of the BacT/Alert as an alternative sterility test for Dendreon's autologous cell therapy product
Timothy Wood, BSc
Dendreon Corporation
Microbial testing of 351 HCT/Ps intended for commercialization
Miguel Nogueras, BS, MT
BioReliance
Potency Assays
Potency assay validation for Auto-CD34+ HPC
Carolyn Keever-Taylor, PhD
Medical College of Wisconsin
Product potency in cord blood products
Donna Regan, MT(ASCP)SBB
Cardinal Glennon Children's Hospital
Development of a Potency Assay for GVAX Prostate Cancer Cellular Immunotherapy
*Presentation not available*
Shirley Clift
Cell Genesys, Inc.
Potency of multi-virus specific CTL from allogeneic donors
Ann Leen, PhD
Baylor College of Medicine
Product Stability
Introduction: Stability Programs
Janice Davis-Sproul, MAS, MT(ASCP)SBB
Johns Hopkins Medicine
Development of a Stability Program for a Cord Blood Bank
Safa Karandish, MT(ASCP)
MD Anderson Cancer Center
Short-Term Stability: Validation of NK Cell Activation During Long-Distance Shipping
David McKenna, Jr., MD
University of Minnesota Medical Center
Development of a Stability Program in support of a BLA for a Stem Cell Therapeutic
Michelle LeRoux Williams, PhD
Osiris Therapeutics, Inc.
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