Translating Pluripotent Stem Cell Discoveries to the Clinic: Preclinical, Manufacturing, and Regulatory Strategies for Success

“Experts in the preclinical, clinical, and regulatory phases discuss critical processes and strategies in development of PSC-derived therapies: selecting the cell line, characterizing the product and manufacturing considerations, managing the immune system, and working with regulators throughout the process.”

Speakers & Topics

Preclinical Strategies

Sponsored by : Astellas Institute for Regenerative Medicine

April Craft, PhD, Boston Children’s Hospital, USA
Doug Melton, PhD, Vertex Pharmaceuticals and Harvard University, USA
Su-Chun Zhang, MD, PhD, Duke-NUS Medical University, Singapore and University of Wisconsin-Madison, USA
Kareen Coulombe, PhD, Brown University, USA

Selecting Your Cell Line: Derivation and Characterization

Sponsored by: ElevateBio

Tenneille Ludwig, PhD, WiCell, USA
Nissim Benvenisty, PhD, Hebrew University, Israel
Jennifer Dashnau, PhD, Century Therapeutics, USA

What’s In Your Product

Bahram (Bob) Valamehr, PhD, MBA, FATE Therapeutics, USA
Angela Keightley, PhD, BlueRock Therapeutics, Canada

New Technologies/Where Are We Going?

Howard Kim, PhD, The New York Stem Cell Foundation (NYSCF), USA
Kapil Bharti, PhD, NIH, USA
Peter Zandstra, PhD, University of British Columbia, Canada
Odette Becheau, TreeFrog Therapeutics, France
Kiera Dwyer, Brown University, USA

Immunology for Cell Therapies

Ran Jing, PhD, Harvard Medical School, USA
Sonja Schrepfer, MD, PhD, Sana Biotechnology, USA
Shin Kaneko, MD, PhD, CiRA, Kyoto University, Japan

Balancing Science and Regulatory Requirements in Emerging Fields

Sponsored by: Cellino Biotech

Anthony Oro, MD, PhD, Stanford University, USA
Gesine Paul-Visse, MD, Lund University, Sweden
Melissa Carpenter, PhD, ElevateBio, USA

How to Accelerate with Accelerated Designations

Jane Lebkowski, PhD, Regenerative Patch Technologies, USA
Masayo Takahashi, MD, Vision Care, Inc., Japan

Delivering Your Cell Product: Strategies for Success

Sponsored by: Vertex Pharmaceuticals

Timothy Kamp, MD, PhD, University of Wisconsin, USA
Cory R. Nicholas, PhD, Neurona Therapeutics, USA