CIRM & friends join efforts for one-day focus on translating stem cells into products

This is my public service announcement for the week. ISCT continues to stack on the value to it's annual meeting this year in San Diego with the recent announcement that ISCT, CIRM, and ISSCR are collaborating to bring a unique cell therapy translational development workshop to California.

Translation of Stem Cell Therapies:
Best Practices and Regulatory Considerations

Sheraton San Diego Hotel and Marina

Saturday, May 2, 2009

DRAFT PROGRAM

7:00am – 7:50am Registration

7:50am – 8:00am Welcome + Introduction

8:00am – 10:00am Introduction to Translation of Stem Cell Therapies
Session chair: EJ Read MD

CIRM’s Initiatives for Translation of Stem Cell Therapies
Marie Csete, MD PhD (CIRM)

FDA’s Approach to Stem Cell Therapies
Kimberly Benton PhD (FDA/CBER/OCTGT)

IND Planning & Preparation for Stem Cell Therapies
EJ Read, MD (BSRI/UCSF-CTSI)

CMC Preparation & Pitfalls for Stem Cell Therapies
Darin Weber, PhD (Biologics Consulting Group)

Q&A/Panel Discussion


10:00am – 10:20am Break


10:20am – 11:50pm Late-Stage Translation: Cell Banking and GMP Manufacturing Models
Session chair: Shelly Heimfeld PhD

Cell Banking: FDA Perspective
Brenton McCright PhD (FDA/CBER/OCTGT)

Banking/Manufacturing Approach for Banked, Off-the-Shelf hESC-Derived Allogeneic Product (Oligodendrocytes, for spinal cord injury)
Anthony Davies, PhD (Geron)

Manufacturing Approach for a Banked, Off-the-Shelf Allogenic Fetal-Derived Product (CNS Stem Cells, for neurology applications)
Stewart Craig, PhD (StemCells Inc)

Manufacturing Approach for a Patient-Specific Allogeneic Expanded Cord Blood Progenitor Cell Product
Shelly Heimfeld, PhD (Fred Hutchinson Cancer Research Center)

Q&A / Panel Discussion


11:50pm – 12:50pm Lunch


12:50pm – 2:20pm Mid-Stage Translation: Assay Development and Preclinical Safety Testing
Session chair: Darin Weber PhD
FDA panelists: Theresa Chen PhD, Thomas Finn PhD

Assay Development for Stem Cell Products
Melissa Carpenter, PhD (Carpenter Group)

Preclinical Safety Program for Myeloid Progenitor Cell Product for Neutropenia and Radiation Injury
Holger Karsunky, PhD (Cellerant)

Preclinical Safety Program for hESC-Derived Products for Neurology Applications
Hans Keirstead, PhD (California Stem Cell and UC-Irvine)

Q&A / Panel Discussion


2:20pm – 3:20pm Mid-Stage Translation: Process Development and Product Characterization
Session Chair: Shelly Heimfeld PhD

FDA Perspective on Development & Characterization Issues
Thomas Finn, PhD (FDA/CBER/OCTGT)

Universal Donor Adult Stem Cell Product (for cardiovascular and other applications): Development and Characterization
Robert Deans, PhD (Athersys)

Gene-Modified Adult Stem Cell Product (for neurology applications): Development and Characterization
Casey Case, PhD (SanBio)

Q&A / Panel Discussion


3:20pm – 3:40pm Break


3:40pm – 4:20pm Early-Stage Translation: Challenges for Developing Combination Products
Session chair: Darin Weber PhD

Case study: Development of a Complex Combination Product (Device + Cells + Genetic manipulation)
B. Lynn Allen-Hoffman. PhD (Stratatech)

Q&A

4:20pm – 5:30pm Early-Stage Translation: Induced Pluripotent Stem Cells
Session chair: Marie Csete MD PhD

IPS cells in Amyotrophic Lateral Sclerosis
Evangelos Kiskinis, PhD (Harvard Stem Cell Institute)

IPS cells in Spinal Muscular Atrophy
Clive Svendsen, PhD (U of Wisconsin)

5:30pm – 5:40pm Wrap Up

5:45pm – 7:15pm Reception