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Speakers

Mapping Pre-Clinical and Clinical Timelines to CMC and CMC Regulatory Strategies

November 14-15, 2018
  • Washington, DC

Mehrshid Alai
Head of Global CMC
Kite Pharma, a Gilead Company

Scott Burger
Principal
Advanced Cell & Gene Therapy, LLC

Alba Creasey
Vice President, Therapeutics & Strategic Infrastructure
California Institute for Regenerative Medicine

Anthony Davies
Founder & CEO
Dark Horse Consulting Inc.

Anne-Virginie Eggimann
Vice President, Regulatory Science
bluebird bio, Inc.

Alicia Gilbert
Director of Regulatory Affairs – CMC
REGENXBIO Inc.

Lisa Kadyk Ph.D
Associate Director, Therapeutics
California Institute for Regenerative Medicine

Aby J. Mathew
Senior Vice President and Chief Technology Officer
BioLife Solutions Inc.

Manal Morsy, MD, PhD, MBA
Senior Vice President and Head of Global Regulatory Affairs
Athersys, Inc.

Tejashri Purohit-Sheth
Director/DCEPT, Office of Tissues and Advanced Therapies, CBER
U.S. Food and Drug Administration

Alan Smith
Executive Vice President, Technical Operations
Bellicum Pharmaceuticals

Elizabeth Smith
Senior Strategic Development Advisor – Retired
Juno Therapeutics

Kaye Spratt, PhD
Senior Vice President, Regulatory Affairs
Abeona Therapeutics, Inc.

Lisa Taylor
Gene and Cell Therapy Consultant, Former Vice President –
Head of Healthcare Law and Compliance
Juno Therapeutics

Mehrshid Alai
Head of Global CMC
Kite Pharma, a Gilead Company

Scott Burger
Principal
Advanced Cell & Gene Therapy, LLC

Alba Creasey
Vice President, Therapeutics & Strategic Infrastructure
California Institute for Regenerative Medicine

Anthony Davies
Founder & CEO
Dark Horse Consulting Inc.

Anne-Virginie Eggimann
Vice President, Regulatory Science
bluebird bio, Inc.

Alicia Gilbert
Director of Regulatory Affairs – CMC
REGENXBIO Inc.

Lisa Kadyk Ph.D
Associate Director, Therapeutics
California Institute for Regenerative Medicine

Aby J. Mathew
Senior Vice President and Chief Technology Officer
BioLife Solutions Inc.

Manal Morsy, MD, PhD, MBA
Senior Vice President and Head of Global Regulatory Affairs
Athersys, Inc.

Tejashri Purohit-Sheth
Director/DCEPT, Office of Tissues and Advanced Therapies, CBER
U.S. Food and Drug Administration

Alan Smith
Executive Vice President, Technical Operations
Bellicum Pharmaceuticals

Elizabeth Smith
Senior Strategic Development Advisor – Retired
Juno Therapeutics

Kaye Spratt, PhD
Senior Vice President, Regulatory Affairs
Abeona Therapeutics, Inc.

Lisa Taylor
Gene and Cell Therapy Consultant, Former Vice President –
Head of Healthcare Law and Compliance
Juno Therapeutics