November 29, 2011

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Presentations:

Opening Remarks
William Janssen, PhD
ISCT
Anita Szajek, PhD
USP

Ancillary Materials in Cell Therapy Products

USP Perspective on Ancillary Materials, Selection, Qualification, Standards
Elizabeth J. Read, MD

Challenges for the Cell Therapy Manufacturer
David Stroncek, MD

Cellular Therapies Pharmacovigilance

Cellular Therapies Pharmacovigilance
Lisa Beth Ferstenberg, MD

Hemovigilance
Barbee Whitaker, PhD

Challenges to Cellular Therapies Development and Potential Avenues for FDA Help in Overcoming Them
Kurt Gunter, MD

October 21, 2010

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Presentations:

Opening Remarks
William Janssen
ISCT
Phyllis Warkentin
FACT

Unrelated Allogeneic Peripheral Blood Hematopoietic Progenitor Cells

An Overview of Unrelated Donor HPC(A) Usage Under the NMDP-held IND
Dennis L. Confer, MD
NMDP
National Marrow Donor Program:Unrelated Donor Experiences
John P. Miller, MD, PhD
NMDP
Effects of Filgrastim Mobilization Therapy on Unrelated PBSC Donors
-not captured in the PBSC trial
Corina E. Gonzalez, MD
Georgetown University Hospital

September 10, 2009

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Presentations:

Current Status of Information System

Blood Banking Systems
Allene Carr-Greer, MT(ASCP) SBB
AABB
Biovigilance Systems
Barbee Whitaker, PhD
AABB
CIBMTR Systems
Doug Rizzo, MD, MS
CIBMTR

Information Systems Under Development

Cord Blood Bank Systems
Julia Breyer
NMDP
Cord Blood Bank Systems
John McMannis, PhD
MDACC Cord Blood Bank
Cell Therapy Systems
Grace Kao, MD
ISCT
Cell Therapy Systems
Albert Donnenberg, PhD
PACT
Tissue Systems
Scott Brubaker, CTBS
AATB

FDA Overview

David Doleski, OCBQ/DMPQ, FDA

Mary Malarkey OCBQ/CBER, FDA

October 17, 2008

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Presentations:

T-Cell Therapies for Malignancies
Stephen Gottschalk, MD
Center for Cell and Gene Therapy, Baylor College of Medicine

Adoptive T-Cell Transfer for Metastatic Melanoma
James Yang, MD
Surgery Branch, NCI

Adoptive T-Cell Therapy for Melanoma: Production Steps and Associated Costs
Lazlo Radvanyi, MD, PhD
MD Anderson Cancer Center

Autologous Expanded T-Cell Therapy in Post-Transplant Setting
Carl June, MD
Abramson Center at University of Pennsylvania

Review of Cost Recovery Regulations and Procedures for Cell and Gene Therapy Products and Medical Devices
Thomas Finn, PhD
OCTGT, FDA

HESC-Derived Cell Therapies: Safety in Translation
Marie Csete, MD, PhD, CSO
California Institute for Regenerative Medicine (CIRM)

Issues to Consider for Safety Testing
Mahendra Rao, MD, PhD
Invitrogen

February 5, 2008

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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

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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

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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

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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

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June 24, 2005

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November 5, 2004

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