Pre-Conference Workshop Day
Monday, December 1
8:00 am Morning Registration & Coffee
9:00am Workshop A
Harnessing Predictive Modeling to Decode Mechanism of Action in Cell Therapy Development for Potency Assays & Decision Making
Synopsis
Understanding the mechanism of action (MoA) is essential to guide development, manufacturing, and regulatory strategy for cell therapies. This workshop explores how predictive modeling can integrate complex biological data to clarify MoA, improve product characterization, and inform critical decisions across all stages of development.
Join this workshop to:
- Learn how to leverage both surrogate and cell-based assays to drive confident data-driven progress
- Discover how predictive modeling helps translate complex biological signals into actionable insights about cell therapy mechanisms and functionality
- Explore strategies for integrating multi-dimensional data to better understand MoA and support product consistency and potency claims
- Learn practical approaches to apply predictive models in decision-making across assay development, manufacturing controls, and regulatory submissions
12:00 pm Lunch Break & Networking
1:00pm Workshop B
ASCP/ACP-Accredited & CMLE-Granting Flow Cytometry Training: Developing & Validating GMP & IVD-Ready Flow Cytometry Assays for Regulatory Success
Synopsis
Flow cytometry is a vital tool for developing robust, GMP and IVD compliant assays, critical to cell therapy product characterization and regulatory submissions. This ASCP/ ACP-accredited and CMLE-granting session combines expert teaching with interactive tools to guide you through designing and validating flow cytometry assays for drug characterization and manufacturing, as well as for IND or BLA filings; all while earning recognized CMLE credits towards your specialist in cytometry certification (SCYM) and CLIA/CAP requirements.
Join this workshop to:
- Earn three recognized CMLE credits through interactive learning, quizzes, and a certificate signed by an ASCP/ACP-accredited instructor
- Master the design and validation of flow cytometry assays, that meet GMP and IVD standards and regulatory requirements for flow cytometry assays such as potency, product identity, safety testing, and clinical trial immunomonitoring
- Gain hands-on experience using commercially available tools (e.g. Cytek Panel Designer) with expert guidance on panel design
- Learn best practices for transitioning from research-use-only (RUO) to GMP to IVDcompliant workflows, and avoid common pitfalls in IND/BLA submission