From Bench to Bedside: Defining Robust Release Criteria for Cell Therapies

ABOUT THE WEBINAR

This session brings together leading experts to explore the evolving landscape of release criteria for cell therapy products. Beginning with a comparative overview of release strategies across diverse cell therapy modalities, the discussion will highlight how product type influences requirements for identity, purity, safety, and potency assays, along with early efforts toward assay harmonization across sites. Building on this foundation, the second segment will delve into potency and stability considerations, emphasizing fit-for-purpose quality control (QC) strategies across the development lifecycle and the importance of stage-appropriate testing rigor. The session will conclude with a practical perspective on how cell therapy programs qualify and implement novel in-house release assays, offering insights into innovation while maintaining regulatory confidence. Together, these talks provide a cohesive framework for designing robust, scalable, and reliable release strategies.

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KEY LEARNING OBJECTIVES

  • Differentiate release criteria across cell therapy modalities: Understand how release requirements vary by product type and identify critical assays used to evaluate identity, purity, safety, and potency, while recognizing opportunities for cross-site assay harmonization.
  • Apply lifecycle-appropriate QC strategies: Learn how to design fit-for-purpose potency and stability programs, aligning assay selection and testing rigor with stage of development to ensure consistent product performance.
  • Implement and qualify novel in-house release assays: Gain insight into practical approaches for developing, qualifying, and integrating innovative assays into release testing frameworks while meeting regulatory expectations.
 WEBINAR CHAIRS

Cheryl Cox, MHA, MT(ASCP), CSSMBB
Elected Member Technologist (June 2026 - June 2028), ISCT Lab Practices Committee (LPC)
Director Operations Cell Therapies and Gene Engineering
Moffitt Cancer Center
United States 

Cheryl Cox is the Operations Director of Cell Therapies and Gene Engineering Facility at the Moffitt Cancer in Tampa Florida. Cheryl has provided leadership for cellular therapy facilities over eleven years. She attended the University of Evansville receiving a degree in Clinical Laboratory Sciences and has a master’s in health administration. She is board certified by the American Society of Clinical Pathology as a Medical Technologist Generalist and Supervisor. Cheryl started her career in cardiovascular research at Bristol Myers Squibb. She eventually transferred into Immunology research at BMS. During subsequent years, Cheryl worked at a clinical research organization, a cord blood biotech, a viral vector facility, a cord blood bank, and in clinical correlative studies before moving to Moffitt. Cheryl has over 22 years of management experience with 14 years in cGMP programs. At Moffitt Cheryl has worked on the production of various cellular therapies clinical trial products, overseen BMT Standard of Care, and the implementation of commercial FDA approved products. She has spearheaded new departmental protocols and procedures to achieve compliance with regulatory requirements. Additionally, Cheryl plans and monitors the day-to-day running of the business to facilitate smooth progress while working with superiors to make decisions for operational activities and set strategic goals. Cheryl is an approved FACT auditor, a Lab committee member of ISCT, and an active member of AABB and SITC. 

Joseph (Yossi) Schwartz, MD, MPH
Member, ISCT LRA Committee, North America
Senior Medical Officer
Foundation for Accreditation of Cellular Therapy (FACT) 
United States

Dr. Schwartz received his MD from the Technion – Israel Institute of Technology and his MPH from Columbia University Mailman School of Public Health. He completed an Internal Medicine Residency at Morristown Memorial Hospital, New Jersey as well as Hematology Fellowship at Tel Aviv Sourasky Medical Center; a Research Fellowship at Memorial Sloan Kettering Cancer Center; and a Transfusion Medicine Fellowship at New York Blood Center. Upon completion of his training, he pursued a decades-long career in promoting excellence in the field of Transfusion Medicine, Apheresis & Cellular Therapy across a multitude of facilities. He had served as a Professor of Pathology & Cell Biology at Columbia University Irving Medical Center, before moving to the Moffitt Cancer Center and recently joined FACT as their Senior Medical Officer. In these capacities, He amounted many years of experience directing Transfusion Medicine, Apheresis & Cellular Therapy Services. Throughout his tenure in the field, Dr. Schwartz became an active member of the professional and academic community, serving on standards committees and executive boards. He had been involved in many professional organizations including AABB, CAP, ISCT, and WBMT to name few. He served as the president of ASFA in 2018-2019 and is currently the President of the World Apheresis Association. Seeking to impact clinical practice worldwide, he served on the writing committee of ASFA’s Therapeutic Apheresis guidelines (published on 3-year cycles) for five editions. Furthermore, he promoted quality and standardization through dissemination of the FACT-JACIE international standards for cellular therapy. For these efforts and many more, Dr. Schwartz has earned many honors including the AABB Hemphill Jordan Leadership Award (2019), ASFA’s Presidential Award (2021), Francis Morrison lectureship Award (2023), and Lecturer Award (2024). 

 WEBINAR SPEAKERS

Olive Sturtevant, MHP, MT(ASCP) SBB, SLS, CQA(ASQ)
Senior Administrative Director of Connell & O'Reilly Families at Cell Manipulation Core Facility
Dana Farber Cancer Institute
United States

Olive is currently the Senior Administrative Director of the Connell & O'Reilly Families, Cell Manipulation Core Facility at Dana Farber Cancer Institute in Boston Massachusetts. Prior to this position, she served as the Quality and Regulatory Director the Cell Therapy Programs at DFCI for the first 15 of her 20+ years at DFCI. Olive is very active in several professional organizations; FACT, ISCT, and AABB and serves on a variety of quality and regulatory committees and boards. Olive has 30 plus years in blood banking, clinical laboratory management and cellular manufacturing. In her current role she is directly responsible for the Financial and Administrative oversight for the GMP manufacturing lab. The DFCI-CMCF laboratory manufactures a variety of both routine HCT/P and investigational cell therapy products and has a robust Cell Therapy Testing Laboratory to support the program. In addition, Olive works with investigators and facilitates the technology transfer of projects and works to maintain project timelines, tracking progress against goals, coordinates with quality assurance and technical experts to fulfill program’s contracts. Olive also serves as the Quality Assurance Director for DFCI’s contracted transfusion services and as a Quality and Regulatory Advisor for the Brigham and Women's Hospital IVF’s Laboratory. She is also an Accreditation Inspector for AABB, CAP and FACT and provides technical, quality and regulatory guidance for both blood banks, cellular therapy and tissue related programs. 

Lindsay Davies, PhD
Chief Executive Officer
QVance AB
Sweden

Dr. Lindsay Davies completed her PhD in 2006 at Cardiff University, UK. Focusing on cell therapy for cartilage repair, with a career in advanced therapies spanning over 20 years across Europe. In 2020, Dr. Davies moved into industry setting up her own consulting company, CellTherEx supporting the advanced therapy space before also joining NextCell Pharma, a clinical stage stromal cell therapy company as their Chief Scientific Officer. In 2024, Dr. Davies co-founded and launched QVance, a quality control analytics service provider for advanced therapy developers, where she is CEO in addition to her continued CSO role at NextCell. Today, Lindsay is a well-recognised KOL in the ATMP community, recently elected as Vice President Elect for Europe at the ISCT, sitting on their European Task Force and several committees related to process development and commercialisation, as well as the inaugural Chair for ISCT’s European Industry committee. She is also an industry representative for the Swedish national ATMP coordinating team and a board member for a number of national and international entities. 

Brigitte Sénéchal, PharmD, CP, PhD
Associate Professor & Associate Director of Quality and Operations, Immunologic Monitoring and Cellular Products Laboratory (IMCPL)
University of Pittsburgh School of Medicine
United States

Brigitte Senechal brings more than two decades of international leadership in laboratory medicine, immunology, and advanced cellular therapies. At Memorial Sloan Kettering Cancer Center (MSKCC), she directed Quality Control and Immunomonitoring for Cell Therapy and Cell Engineering (2015–2024), leading a specialized team in shaping product and process standards across eight IND-approved clinical trials. She oversaw the release of more than 150 cell and gene therapy products, guiding complex manufacturing and clinical strategies that balanced safety, efficacy, and feasibility. Her leadership extended beyond operations: she established innovative quality systems, including a relational database for meta-data analysis and risk-assessment frameworks, ensuring robust regulatory compliance (cGMP, CBER, FACT, ICH). Brigitte played a pivotal role in MSK’s FACT accreditation and represented institutional quality strategy in high-level regulatory engagements. Previously, as head of the Virology/Molecular Unit at Public Health England (2008–2015), she managed international proficiency testing programs, strengthened global collaborations, and ensured accreditation standards for infectious disease diagnostics. Her leadership was marked by global-scale coordination, regulatory engagement, and capacity-building for partner laboratories. Her career reflects consistent excellence in bridging science, clinical practice, and organizational governance. Brigitte has served on multiple biosafety and accreditation committees, contributed to international standards development, and authored widely cited publications in immunology and cell therapy.