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Potency Measurements for Cellular and Gene Therapy Products
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Advanced

This session will offer a comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices. It will explore how regulatory flexibility concerning potency can facilitate and accelerate the development process.

Learning Objectives

Describe the potency requirements for CGT products; Discuss the latest FDA’s guideline regarding potency testing and industry perspectives; Explain the Role of Surrogate Assays enhancing the overall potency assurance strategy; Examine the approaches adopted by sponsors to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Panelist
Andrew Byrnes, PhD

Potency matrix for a complex mechanism of action: case-study for a multi-component plasmid immunotherapy for prevention or delay of type 1 diabetes
David Campard, PhD, MSc

Comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices
Maria Amaya, PhD, MS

Developing a matrix approach for potency assessment in allogeneic cell therapy: a case study in standardization and predictive analytics
Simge Baloglu, PhD, MS


Speakers
LR

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →
AB

Andrew Byrnes

Director, Division of Gene Therapy 1, FDA CBER, United States
Andrew P. Byrnes, PhD, is the Director of the Division of Gene Therapy 1 at FDA’s Center for Biologics Evaluation and Research. The Division of Gene Therapy 1 reviews manufacturing of gene therapy vectors, microbial vectors, cancer vaccines, oncolytic viruses, in vivo genome editing... Read More →
avatar for Maria Amaya

Maria Amaya

Lead External Advocacy, North America, Genentech, A Member of the Roche Group, United States
Maria Amaya is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and CGMP regulatory pathways, and collaborate with internal... Read More →
avatar for Simge Baloglu

Simge Baloglu

SVP Analytical and Quality Control, Bluerock Therapeutics, United States
Simge Baloglu, PhD, is an Analytical Development and Quality Control leader with over 20 years of experience in biologics, gene and cell therapy, and vaccines. She has led analytical and CMC strategies from discovery through commercialization, regulatory approval, and lifecycle management... Read More →
avatar for David Campard

David Campard

CMC RA Specialist, Novo Nordisk A/S, Denmark
David Campard is CMC Regulatory Affairs Specialist and leads multiple early development projects at Novo Nordisk for cell and gene therapy products (CGTPs). In this role, he set the regulatory strategy for CMC development of CGTPs in alignment with other areas (clinical, non-clinical... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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