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#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-576-L04-P; CME 1.00; RN 1.00

Explore regulatory and manufacturing challenges in cell and gene therapy, including starting material variability, potency testing, comparability, specification, and stability strategies. Gain insights into FDA expectations, ICH initiatives, and collaborative approaches to harmonize definitions and accelerate development while ensuring quality and regulatory clarity across individualized therapies.

Learning Objectives

Identify key regulatory and manufacturing challenges in CGT development, including starting material variability, comparability, stability, setting specifications, and post-approval changes; Discuss FDA and global expectations, harmonization needs, and strategies for individualized therapies to ensure quality and compliance across development phases.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Defining and Controlling Raw and Starting Materials for CGT Manufacturing
Kevin Carrick, PHD

Comparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing Process
Andrew Chang, PHD

Setting specifications for ATMPs: insights from the ICHQ6 revision
Cecilia Tami, PHD

Stability Considerations for Cell and Gene Products
Akanksha Kaushal, MS


Speakers
avatar for Kevin Carrick

Kevin Carrick

Senior Director, Science and Standards, Biologics, United States Pharmacopeia, United States
Dr. Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the five USP Expert Committees and multiple Expert Panels in the area of biologics to develop standards that support biopharmaceutical quality assessment... Read More →
avatar for Andrew Chang

Andrew Chang

Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 30 years well-rounded medical product regulatory and industry experiences. He is a member of the board of directors for Parenteral Drug Association (PDA). Andrew has served as a member of the planning committee for DIA... Read More →
avatar for Akanksha Kaushal

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States
Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session

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