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Up to the challenge: Manufacturing’s central role in the cell- and gene-therapy revolution

Start Date:6/22/2020

Start Time:3:00 PM EDT

Duration:60 minutes


Pharma took a huge leap from small-molecule drugs to biologics, and now it’s taking another one as the industry beefs up in cell and gene therapies. Some 800 such therapies are moving through the biopharma pipeline, and former FDA commissioner Scott Gottlieb expects 10 to 20 to be approved annually by 2025. Drugmakers, CDMOs, and even hospitals are investing big money in production capacity and the complicated supply-chain infrastructure necessary to make all that happen. The upfront investment is daunting, and the complexity of the production processes themselves are unmatched in the rest of the pharma world. In this session, our experts will describe the state of play in cell and gene therapy manufacturing today, and outline the growth and changes necessary to keep up with demand as the next-generation therapies make their way through pipelines, past regulators and to patients themselves.

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Kyle Blankenship


Fierce Pharma

Steffan Lang

Global Head - Technical Operations


Steffen Lang, Ph.D., is the Global Head of Novartis Technical Operations, and a member of the Executive Committee of Novartis. He joined Novartis in 1994, and over the years has held positions of increasing responsibility within Pharmaceuticals Development, including Global Head of Technical Research and Development. Before his current role, he was the Global Head of Biologics Technical Development and Manufacturing. Mr. Lang holds a doctorate in pharmaceutical technology and a master’s degree in pharmaceutical sciences.

Donald Wuchterl

Senior Vice President of Technical Operations

Audentes, An Astellas Company

Donald Wuchterl has served as Senior Vice President of Technical Operations at Audentes Therapeutics since January 2016. He is responsible for the company’s Quality, Manufacturing, Supply Chain, Facilities & Engineering, and Process & Analytical Development teams. Mr. Wuchterl has more than 25 years of experience in manufacturing clinical and commercial GMP products including biologics, small molecules, cellular immunotherapies, and AAV gene therapies. Mr. Wuchterl has extensive experience in the design, buildout, validation, licensure, and operation of these facilities.

Charles Calderaro

Global Head of Technical Operations

Kite, a Gilead Company

Charles Calderaro joined Kite in December 2019 as global head of Technical Operations. Previously he served as the senior vice president, Global Manufacturing for BioMarin, where he was accountable for a diverse international operations network, which utilized gene therapy, biological, small molecule, medical device and packaging technologies to deliver innovative clinical and commercial products to patients. His more than 30 years of experience at Genentech/Roche, Aventis-Behring, Alcon Labs and Johnson & Johnson spans all aspects of technical operations.

Robert Baffi, Ph.D

Special Advisor to the Chairman and Chief Executive Officer


Robert A. Baffi, Ph.D., joined BioMarin in 2000, serving for over 20 years in critical executive leadership roles at the company. In May 2020, Dr. Baffi began his planned transition to retirement by moving from President, Global Manufacturing and Technical Operations to Special Advisor to the Chairman and Chief Executive Officer. As part of his current role, he is assisting with the regulatory review of valoctocogene roxaparvovec, an investigational gene therapy for hemophilia A, and the preparation of the vosoritide marketing application.

Thomas Vancott, PhD

Chief Technology & Strategy Officer

Catalent Cell & Gene Therapy

Dr. VanCott joined Catalent following 14 years as the President and CEO of Advanced Bioscience Laboratories, Inc. (ABL). Before joining ABL, he held several positions at the Henry M. Jackson Foundation for the Advancement of Military Medicine. He also served as a U.S. Army Captain in the Medical Service Corps at Walter Reed Army Institute of Research. He received his PhD in Physical Chemistry from University of Virginia and a B.S. degree in Chemistry from Dickinson College.

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