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Monday, June 28 • 1:00pm - 2:00pm
#120 SL: Defining Quality for Cell and Gene Therapy Products

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

Cell and Gene Therapy products are rapidly moving from early proof of concept and investigational studies to demonstration of clinical benefit and commercial approval. US and global regions have certainly helped bring important life-changing therapies to patients with remarkable expediency. However, development of robust product quality implementation and characterization often lags behind their rapid clinical programs. To help fill this gap, FDA has encouraged early product characterization, the evaluation of multiple product attributes, and development of a broad set of analytics. This “cast a wide net” approach allows for pruning of different methodologies during the product lifecycle and elevating tests for attributes associated with discernable changes and impacts to product safety, quality and efficacy. FDA has allowed flexibility in method development, specification setting and the identification of CQA in early phases.However, FDA expectation is that fully validated methods will be in place for licensure and that acceptance criteria will be established based on clinical efficacy studies. The transition from the flexible early phase to a more robust late phase expectation, highlights the critical importance for well-planned and step-wise control strategy and control system.

Learning Objectives

Explain how to identify critical quality attributes for cell and gene therapy products; Outline when it is appropriate to set quality standards during investigational studies; Identify resources available for standard setting for cells and gene therapies.


Michael Havert, PhD


Industry Update
Keith Wonnacott, PhD

Data Analytics and Consistency for CAR-T Methods
Prentice Curry

avatar for Michael Havert

Michael Havert

Vice President, Regulatory affairs, StrideBio, United States
Mike was trained as a virologist and has experience in the development of genetic medicines for the treatment of rare diseases and cancer. Mike recently worked at the CMC/regulatory interface for HSCT gene therapy programs at bluebird bio. Prior to his current position, Mike served... Read More →
avatar for Prentice Curry

Prentice Curry

Senior Vice President, Quality and Compliance, Kite Pharma, United States
Prentice Curry has been a biotechnology and pharmaceutical professional for more than 30 years. He started his career at Cetus Corporation, one of the first biotechnology start-up companies in quality laboratory and manufacturing roles. Prentice then subsequently worked for Amgen... Read More →
avatar for Keith Wonnacott

Keith Wonnacott

Executive Director, Regulatory Affairs, Pfizer Inc, United States
Dr. Keith Wonnacott has 20 years of regulatory experience in the field of cell and gene therapies. He joined Pfizer as an Executive Director of Regulatory Affairs in their Rare Diseases Unit in 2017. At Pfizer, Dr. Wonnacott has a combined role working on regulatory strategy and regulatory... Read More →

Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session |   06: PreClin Dev-EarlyPhaseCR, Session