Webinar

The 2026 Cell Therapy Regulatory Landscape: Aligning CMC Strategy with FDA and EMA Expectations

May 21, 2026 11:00am ET

60 Minutes

In 2026, the global regulatory framework for cell-based therapies continues to evolve, placing increased emphasis on robust CMC control strategies, comparability planning, and lifecycle management. As FDA and EMA refine expectations, developers face growing pressure to align manufacturing decisions with regulatory requirements early in development, particularly as programs expand toward large patient populations.

In this panel discussion, regulatory and manufacturing experts will examine key FDA and EMA nuances impacting cell therapy programs, explore how evolving guidance influences CMC strategy and manufacturing considerations, and discuss what developers should anticipate when designing scalable, globally viable programs.

The session will provide practical insights for teams navigating IND-to-commercial transitions in an increasingly structured regulatory environment, including considerations for manufacturing scalability and long-term lifecycle management.

Understand how evolving FDA and EMA expectations are shaping CMC strategies for cell therapies, particularly around comparability, process changes, and lifecycle management as programs move toward commercialization.
Learn how to align manufacturing strategies with regulatory expectations early in development, helping teams design scalable, globally viable programs and avoid costly rework later.
Gain perspective on emerging regulatory trends impacting cell therapy development, including increasing expectations for robust control strategies, stronger analytical packages, and greater readiness for scale and lifecycle management.

Speakers

Tiffany Lucas, PhD

Regulatory Affairs Practice

U.S., Eliquent LifeSciences

Dr. Tiffany Lucas applies her FDA expertise in cell and gene therapies and her background as an investment analyst to deliver strategic chemistry, manufacturing, and controls (CMC) guidance. She enhances regulatory submissions across all phases of product development, from pre-IND to post-commercialization.

Dr. Lucas possesses over six years of regulatory experience as a reviewer at the U.S. Food and Drug Administration (FDA), where she led the review of cell and gene therapy products within the Center for Biologics Evaluation and Research (CBER). During her tenure at the FDA, she oversaw an extensive portfolio of cell and gene therapy products, spanning from pre-IND stages through license approval and post-licensure changes. She chaired a Biologics License Application (BLA) for an approved product, lead Pre-License Inspection (PLI) activities for the product office, and she served as a CMC reviewer for multiple BLAs.

Her CMC cell and gene therapy experience covers FDA regulatory meetings, submissions, comparability studies, manufacturing scale-up/out, analytical assays and validations, potency assays, non-conforming product and manufacturing deviation issues, pre-licensure inspections for products, commercial release specifications, viral vector and cell manufacturing, and rare disease product development challenges.

Dr. Lucas’ background as an investment analyst and in technology licensing, patents, and risk assessment enhances her understanding of program and product development strategies. She understands that each product is unique, and she provides customized advice tailored to each program.

Nandini Kashyap, MPharm

Conference Director

Fierce Life Sciences

Nandini Kashyap is Conference Director for Fierce Pharma/Biotech and founder of CenterStage Media, an events and marketing venture. Former scientist and a seasoned strategist and business connector, she has led 100+ global conferences and B2B events across pharma and biotech specializing in conference production, strategic partnerships and executive engagement, operations, thought leadership. Previously, she served as Senior Director of Conferences & Social Media Strategy at Cambridge Innovation Institute and Director of Novel Drug Delivery at Biodel Inc.

Beyond conferences, Nandini is also a recognized life science ambassador and has been featured on campaigns for Novartis, Takeda, Philips, Dana-Farber, Werfen, and Salesforce and more. Ms. Kashyap holds a Master’s in Pharmaceutics from NIPER (India), a Bachelor’s in Pharmacy from New Delhi, and postgraduate certifications from Cornell (Marketing & Social Media Strategy) and MIT (Controlled Release Technologies).

Catherine Tomaro-Duchesneau, Ph.D.

Senior Director of Manufacturing and MS&T

RoslinCT

Catherine Tomaro-Duchesneau, Ph.D. is Senior Director of Manufacturing and MS&T at RoslinCT, where she leads both Manufacturing and MS&T functions across diverse cell therapy modalities, including autologous and allogeneic platforms. With a strong track record of advancing therapies, including from pre-clinical to commercial stages, she brings deep expertise in process development, scale-up and scale-out, GMP manufacturing, and technology transfer. Dr Tomaro-Duchesneau has successfully led numerous internal and external (CDMO) technology transfers through routine manufacturing, supporting the seamless translation of innovative therapies to patients.

Jonelle Chapman

Head of Regulatory Affairs, Cell Medicines

Regeneron

Jonelle brings deep regulatory leadership across cell and gene therapy programs, with a career spanning early development through global approvals.

Prior to Regeneron, Jonelle served as Vice President of Regulatory Affairs at Vor Bio (2024–2025), supporting cell therapy programs for the treatment of AML. She previously held leadership roles at Biogen (2021–2023), where she advanced the company’s early gene therapy portfolio. From 2018–2021, Jonelle worked at Autolus Therapeutics, a biotechnology company focused on next‑generation CAR‑T cell therapies across multiple oncology indications. During her tenure, she held roles of increasing responsibility, culminating as Vice President of Regulatory Affairs. In this role, she led early regulatory activities across multiple programs, including global health authority interactions, expedited designation strategies, and initial IND/CTA filings, and she directed early BLA planning for obe‑cel, the company’s lead candidate approved in 2024.

Jonelle began her career at Novartis, where she spent 12 years. Most recently, as Global Program Regulatory Director within Novartis’ Cell and Gene Therapy Unit, she led strategic regulatory activities across cell and gene therapy programs and later assumed responsibility for the CD19 CAR‑T therapy Kymriah across multiple lymphoma indications. She played a key role in securing U.S. regulatory approval for Kymriah in adult DLBCL, as well as approvals in regions including Canada and Switzerland for pediatric ALL and DLBCL.

Jonelle holds a PharmD from the University of Maryland, Baltimore, and a Bachelor of Science in Biochemistry from the University of Minnesota, Twin Cities.

Kathy Burri

Head of Quality

RoslinCT

Kathy oversees the daily operations of the Quality Assurance and Quality Control Organizations at the RoslinCT US site. Kathy has more than 30 years of experience in Quality for both clinical and commercial manufacturing. Her primary experience is in biologics but also has experience in cell therapy and combination products.

As Vice President of Quality at RoslinCT USA (formerly Lykan Bioscience), Kathy’s global agency experience includes US, EMA and TGA as well as other international agency experience. She has hosted both pre-approval inspections as well as routine GMP inspections. Kathy is committed to establishing a strong Quality Culture and efficient Quality Management System while embracing data-driven risk assessments and continuous improvement.

Prior to joining RoslinCT, Kathy held various leadership roles in Quality at Alexion, Shire, Lonza, Biovest International, and Q-One Biotech.

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Date/Time:

May 21, 2026 11:00am ET