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ISCT has hosted 7 Liaison Meetings with the FDA. Information pertaining to each of these meetings follows:
February 5, 2008
For a complete meeting summary, please click here.
Presentations:
FDA Cell Selection Point of Care Draft Guidance
Joyce L. Frey-Vasconcells, PhD
Executive Director, PharmaNet Consulting
Use of Devices and Manufacturing Equipment in Cellular Therapy
John Gilbert, PhD
Piconomics
SPECIALTY TOPICS
Cell Sorting and Cell Selection
John McMannis, PhD
Professor of Cancer Medicine
Director, Cell Therapy Laboratory
Technical Director, UT MDAnderson Cord Blood Bank
Role of Equipment in the Manufacturing of Pancreatic Islets
Elina Linetsky, MSc, MT
Manager, QA/Regulatory Affairs
University of Miami, Diabetes Research Institute
Devices and Manufacturing Equipment Used for Production of Immune Cell Therapy and Cell Expansion: Scientific/User Issues
Bruce Levine, PhD
Director, Clinical Cell and Vaccine Production Facility
University of Pennsylvania, Department of Pathology and Laboratory Medicine
June 7, 2007
For a complete meeting summary, please click here.
Presentations:
FDA CORD BLOOD GUIDANCE DOCUMENT
Summary of Industry’s Concerns to Draft Guidance on Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
Joseph Giglio, MS, MT(ASCP), CSQE(ASQ)CQA
Deputy Director of Regulatory Affairs, AABB
FDA Liaison Meeting for Cellular Therapy Organizations
Robert Soiffer, MD
President - American Society for Blood and Marrow Transplantation
Comparability of Cord Blood Units
John D. McMannis, PhD
Professor of Cancer Medicine
Director, Cell Therapy Laboratory
Technical Director, UT MDAnderson Cord Blood Bank
Transplantation of UCB Units Manufactured outside the USA -U of MN Experience-
David McKenna, MD
Medical Director, Clinical Cell Therapy Laboratory
University of Minnesota Medical Center
Molecular & Cellular Therapeutics
Unlicensed cord blood products: What should we do?
Elizabeth Read, MD
Director, Cell and Tissue Therapies
Blood Systems Research Institute
San Francisco, CA
New clinical indications and off label use: discussion of additional disease indications and possible mechanisms to add treatment indications in the future.
Joanne Kurtzberg, MD
Director, Carolinas Cord Blood Bank at Duke
*presentation not available*
UNRELATED ALLOGENEIC PERIPHERAL BLOOD HEMATOPOIETIC PROGENITOR CELLS
Regulation of PBSC and DLI from Unrelated Donors: Meeting the Needs of U.S. Transplant Patients
John P. Miller, MD PhD
Senior Medical Director, NMDP
Points to consider in the regulation of HPC-A as a biologic product requireing licensure
Chester Andrzejewski, MD, PhD
Past-President ASFA
*presentation not available*
FDA Approach to the Regulation of Hematopoietic Stem/Progenitor Cells (HPC)
Ellen Lazarus, MD
Medical Officer, Division of Human Tissues
Office of Cellular, Tissue, and Gene Therapies
January 4, 2007
For a complete meeting summary, please click here.
Presentations:
NMDP screening process for PBSC and cord blood donors of products imported into the US
Fran Rabe
NMDP
Importing/Exporting “Conventional” HCT/Ps
Scott A. Brubaker, CTBS
American Association of Tissue Banks
Overview of Regulations of the Major Exporting European Countries
Phil Brown
Quintiles Consulting
Unrelated Products Received From Outside the NDMP Structure
John McMannis, PhD
MD Anderson
Edition of FACT-NetCord Cord Blood Standards and Update on Accreditation of Sites Outside the US
Phyllis Warkentin, MD
University of Nebraska Medical Center
AABB Accreditation of Sites Outside the US
Karen Shoos Lipton, JD
AABB
National Drug Codes for HCT/Ps
Joseph Giglio
AABB
Experimental Evidence Demonstrating “Homologous Use”
Shelly Heimfeld, PhD
Fred Hutchinson Cancer Research Center
Homologous Use Working Group
Shelly Heimfeld, PhD
Fred Hutchinson Cancer Research Center
June 16, 2006
For a complete meeting summary, please click here.
Presentations:
Infusion of Culture Positive Stem Cell Products
Dennis Gastineau, MD
Mayo College of Medicine
*Includes summary of Culture Positive Stem Cell Products survey conducted by ISCT in Spring 2006*
Microbial Testing of Cell Therapy Products-Summary of NIH Clinical Center Studies
Elizabeth Read, MD
National Institute of Health Cell Processing Lab
HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs
Ellen F. Lazarus, MD
FDA/CBER
January 27, 2006
For a complete meeting summary, please click here.
June 24, 2005
For a complete meeting summary, please click here.
November 5, 2004
For a complete meeting summary, please click here.
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