|
This presentation page is supported in part by generous support from:
FDA Perspective:
Celia Witten
OCTGT
Title: Cellular, Tissue and Gene Therapies-Office Update
Novel Therapies:
G. Russell Reiss
University of Utah
Title : Cell Therapy in the Open Heart
Ann Tsukamoto
Stem Cells Inc.
Title: Developing Human Neural Stem Cells for Clinical Applications
Scheffer C.G.Tseng
Ocular Surface Center
Title : Amniotic Membrane Transplantation for Ocular Surface Reconstruction
Joshua Hare
Johns Hopkins Medical Institutions
Title: Regulatory Issues For Cardiac Cell-Based Therapies Using Mesenchymal Stem Cells
Reporting Events:
Elizabeth J. Read
National Institutes of Health
Title : Adverse Event & Deviation Reporting for 351 Cell Therapy Products
Elizabeth Ness
National Cancer Institute
Title : Adverse Event Reporting for IND Clinical Trials
Reporting Scenarios
Release Testing I:
Ellen Areman
Biologics Consulting Group
Title: Perspectives on Testing Cell Therapy Products
Brenton McCright
OCTGT, DCGT
Title: Release Testing of Cell Therapy Products
Diane Kadidlo
University of Minnesota
Title: Evaluating Novel Methods fro Endotoxin Testing of Cellular Products – the PACT Experience
John McMannis
MD Anderson Cancer Center
Title: Sterility Testing: Alternate Samples
Alla Danilkovitch
Osiris Therapeutics, Inc.
Title : Developing a Potency Assay for an Adult Mesenchymal Stem Cell Product
Pocheng Liu
Dendreon Inc.
Title: Potency Assays for an Autologous Active Immunotherapy (Sipuleucel-T)
Release Testing II-Practical Experiences:
Karen Edward
Advanced Cell & Gene Therapy, LLC
Title: Product Release
Jarett Anderson
Mayo Clinic
Title : Pancreatic Islet Product Release
Rebecca Haley
Aldagen, Inc.
Title: Release Criteria for ALDHbr Cells
Facilities Issues for Somatic Cell Therapy Product Manufacture:
James Crim
OCBQ, DMPQ
Title: Facility Design and CGMP Considerations for Cell Therapy Products
Kevin Sheehan
Stanford University
Title: Cell Processing Laboratory Construction-Renovating an Existing Lab Space
Linda Kelley
University of Utah
Title: Designing a ‘New’ GMP Laboratory
Shelly Heimfeld
Fred Hutchinson Cancer Research Center
Title: Environmental Monitoring in the Cell Processing Laboratory
Douglas Padley
Mayo Clinic
Title: The Role of Media Fill Evaluations in Process Control for Manufacture of Cellular Therapy Products
INDs 202:
John McMannis
MD Anderson Cancer Center
Title: INDs 202-Panelists
Title: MD Anderson IND Pathway
Steven Hirschfeld
OCTGT, DCEPT
Title: IND “202” Clinical Perspective
Donald Fink
OCTGT, DCGT
Title: IND 202 Tutorial: Cellular Therapy INDs- The CMC Section
Elizabeth J. Read
National Institutes of Health
Title: Recent Experience with Cell Therapy INDs at NIH Clinical Center
D. Michael Strong
Puget Sound Blood Center
Title: IND 202-The Puget Sound Blood Center Experience
Robert Lindblad
EMMES Corporation
Title: IND 202-Cell Therapy
Donor Issues:
Zbigniew Szczepiorkowski
Dartmouth-Hitchcock Medical Center
Title: Donor Issues
Melissa Greenwald
OCTGT/DHT
Title: Donor Issues Scenario Based Panel “FDA Introduction”
Cord Blood-Future Directions:
Ellen Lazarus
OCTGT, DHT
Title: FDA Update on Cord Blood Banking Regulations
Joanne Kurtzberg
Duke University
Title: Cord Blood Scenarios
Elizabeth J. Shpall
MD Anderson Cancer Center
Title: Ex-Vivo Expanded Cord Blood
James Burdick
Health Resources and Services Administration
Title: Implementation of the Stem Cell Therapeutic and Research Act of 2005
Professional Certification:
Kathy Loper
AABB
Title: Professional Certification Overview
Scott Brubaker
American Association of Tissue Banks
Title: AATB Professional Certification
Patricia A. Tanabe
American Society for Clinical Pathology
Title: ASCP Certification
Sherry Keramidas
Regulatory Affairs Professionals Society
Title: Overview of Certification of Regulatory Affairs
Jeanne Linden
New York State Department of Health
Title: New York State Regulation of Tissue Banks
Kathleen Weiss
Biotech Institute of Maryland
Title: Training Programs and Impact
Kathy Loper
AABB
Title: AABB Model: A Certificate Program
The Quest for Compatibility:
Janice Davis-Sproul
The Johns Hopkins Medical Institutions
Title: The Quest for Compatibility-Session Intro
Jennifer Catalano
OCTGT, DCGT
Title: The International Conference on Harmonization (ICH) and its Relevance to Cell Therapy
Scott Burger
Advanced Cell & Gene Therapy, LLC
Title: International Regulations & Standards for Cell Therapy
Angela Ondo
The Johns Hopkins Medical Institutions
Title : Accreditation Challenges
D. Michael Strong
Puget Sound Blood Center
Title: Tissue & IND Products
Safa Karandish
MD Anderson Cancer Center
Title: The Quest for Compatiblity: FACT/Netcord & NMDP
Corporate Sponsored Breakfast Session
PharmaNet: Potency – What’s Appropriate for Cell Therapies?
| 
