Conference Day One
Tuesday, December 2
7:00 am Morning Registration & Coffee
Driving Analytical Innovation & Regulatory Dialogues to Advance Cell Therapies
8:00 am Industry Leaders Fireside Chat: Shaping the Future of Analytical Development in Cell Therapy by Responding to Evolving Regulations & Investing in Innovation
Synopsis
An interactive panel discussion from the industry leaders of the field to set the scene on the cell therapy analytical development space.
Ask your questions live to understand the experts’ thoughts on key topics, including:
- The implications of recent changes in the FDA and regulations to the analytical development and cell therapy field as a whole
- Recent innovations in analytical methods and platforms that are advancing the field
- What critical hurdles remain in developing, transferring, and validating assays for living cell products?
9:00 am Session Reserved for Miltenyi
9:30 am Bringing Clarity to Regulatory Interactions: Proactive Strategies & FDA Updates to Align Analytical Expectations
Synopsis
- Gain insight into recent FDA leadership and organizational changes, as well as how they influence evolving policy development and its practical enforcement in analytical development
- Explore tactics for presenting data and negotiating assay specifications that reflect real-world manufacturing capabilities and clinical realities
- Learn how early, well-structured engagement with regulators can help align on assay expectations, minimize rework, and support smoother progression through pivotal milestones
10:00 am Session Reserved for Agilent
10:30 am Morning Break & Speed Networking
Early-Stage Analytical Development
Aligning Assay Design & Development with Long-Term Cell Therapy Goals
11:30 am Panel Discussion: Key Considerations to Future Proof Analytical Development Efforts
Synopsis
- How can we ensure sufficient sample retention early to support unforeseen testing and regulatory requirements
- Manage the underestimated complexity and time demands of cell-based and potency assay development
- What are some opportunities for platforming assays to reduce duplication and streamline multi-program assay workflows?
12:00 pm Session Reserved for LumaCyte
Late-Stage Analytical Development
Unifying Assay Validation to Support Reliable & Regulatory-Ready Products
11:30 am Standards & Workflows to Enhance Cell Characterization Analytics & Advance Product Success
Synopsis
- Leverage robust experimental designs and analytical tools that support analytical integrity from early optimization to commercial scale-up
- Implement consistent workflows and platform-agnostic reference standards to overcome inconsistencies in product characterization across the manufacturing process
- Apply the principles of international documentary standards to cell therapy applications
12:00 pm Session Reserved for Accelix
12:30 pm Lunch Break & Networking
1:30 pm Session Reserved for Immudex
1:40 pm Navigating Genomic & Functional Characterization in Gene-Edited Cell Therapies
Synopsis
- Examine assay strategies to confirm both the presence of edits and preservation of cell function post-engineering
- Review real-world approaches for correlating genomic modifications with therapeutic impact using robust analytical endpoints
2:10 pm Interactive Roundtable Discussion: Designing Scalable Assays from Day One for Seamless Late-Stage Success
Synopsis
- Participate in an interactive exercise to identify early assay design decisions that can either streamline or stall future tech transfer and commercialization
- Explore real-world trade-offs around control complexity, reagent burden, and validation readiness
- Collaborate with peers to define best practices for designing assays that scale reliably across sites, platforms, and phases
1:30 pm Session Reserved for Mission Bio
1:40 pm Late-Stage Assay Validation Strategies to Ensure Regulatory Alignment & Commercial Readiness
Synopsis
- Learn how to transition qualified release assays to fully validated methods that meet pivotal and commercial expectations
- Explore key validation criteria robustness, specificity, reproducibility and how to meet them under tight timelines
- Understand how assay maturity and early planning can reduce downstream risks during PPQ and commercialization
2:10 pm Strategic Assay Selection for Clinical Phases & Beyond
Synopsis
- Advancing flow cytometry and ddPCR from RUO to GMP to ensure assay robustness across development stages
- Differentiating target and off-target effects to meet regulatory expectations and strengthen product reliability
2:40 pm Afternoon Break & Poster Session
Strengthening Team Alignment to Transfer Complex Assays with Confidence
3:30 pm Lessons Learned from Cross-Team & Multi-Site Collaboration to Improve Assay Transfer & Scalability
Synopsis
- Assay design decisions, including control selection and technology, greatly affect transfer success and scalability across diverse teams and locations
- Effective strategies to reduce reagent usage help ensure consistent assay performance and comparability across multiple sites
- Real-world insights from navigating collaboration between analytical development and quality control teams reveal key approaches to minimize late-phase challenges and enhance smooth tech transfers
4:00 pm Case Study: Strategy for Seamless Assay Transfer Between Internal & External Teams for Reliable Analytical Results
Synopsis
- Approaches to making implicit knowledge explicit, including hands-on training and site visits, to overcome barriers in transferring complex assays, especially bioassays and cell-based methods
- How to improve alignment and communication between teams to distinguish assay variability from true process changes, ensuring confidence in analytical data
- Best practices for planning and resource management to facilitate smooth assay transfer and reduce troubleshooting time