Consultants' Network
Consultants' Network
From CMC Challenges to Regulatory Strategy: Navigating Cell Therapy Development and Manufacturing | June 22 11:00 EDT | Virtual
Participate in the virtual Consultants' Network. This session brings together two critical perspectives: an in-depth look at how persistent CMC challenges—ranging from variable patient starting material and rising critical material costs to antigen escape and the complexities of solid tumors—are reshaping autologous cell therapy manufacturing and product design; and a strategic overview of global regulatory pathways, highlighting expedited programs, key FDA and EMA frameworks, and the implications of manufacturing models on compliance and speed to market. Registration for this free opportunity closes June 19, 2026.
Consultants are a key component of CASSS membership. The purpose of the CASSS Consultants' Network is to facilitate discussions among consultants.
For more information, contact Anne Ornelas.
Abstract | June 22
Speakers | June 22
Mo Heidaran
Cellx, Inc.
Mo Heidaran, Chief Regulatory Scientist at Cellx, Inc., is an NIH-trained scientist with extensive experience in industrial product development, regulatory science, and advanced therapy manufacturing, specializing in cell and gene therapy and tissue engineering. He brings deep operational knowledge of clinical trial logistics for advanced therapies and a strong track record in translating science into viable products.
Heidaran has authored more than 50 research publications and holds 25 issued patents, with 54 additional patents pending. He is the founder and inaugural Chair of the Gordon Research Conference on Signal Transduction by Engineered Extracellular Matrix.
He serves on the Bio5 Advanced Therapy USP Expert Committee and the ISCT Legal and Regulatory Affairs Committee, and contributes to initiatives with the Alliance for Regenerative Medicine (ARM). His research interests include neurodevelopment, with broader expertise in extracellular matrix biology, stem cell biology, and signal transduction.
Marianna Sabatino
AstraZeneca
Dr. Marianna Sabatino is a scientific leader with more than 20 years of research experience, including 18 years in cell and gene therapy. She has led cell and vector process development and analytical development teams, and has guided CMC strategy across early- and late-stage development for multiple CAR-T and TCR-T programs.
At Kite Pharma, she supported the development of several cell therapy assets, including the commercial products YESCARTA™️ and TECARTUS™️. She later served as Head of Process Development at Autolus Therapeutics and Arcellx, where she led process development activities across pipeline programs and was instrumental in the development of Obe and Anito-Cel.
Earlier in her career, Sabatino was a Staff Scientist in the Cell Processing Section at the National Cancer Institute in Bethesda, Maryland, where she worked on novel manufacturing platforms supporting Phase I/II clinical trials in oncology and regenerative medicine.
Sabatino received her Medical Degree and completed her training in medical oncology at the University of Siena Medical School in Siena, Italy.
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