Day Two Agenda
8:15am - 3:45pm | Boston, MA
8:15 am Registration & Coffee Networking Opens
9:15 am Chair’s Opening Remarks
Managing Phase Development Considerations for Cell Therapy Potency Assays to Promote a Unified Approach
9:30 am Phase Appropriate Approach to Potency Strategy, Phase I Through Phase II Pivotal
Synopsis
- Design, development and Implementation (PreQual, Tech Transfer and Qual) of Lot Release Assay for Potency, Phase I plus improvements going into Phase II pivotal
- A biology-based approach to characterization
- Phased approach to expanding on product characterization
10:00 am Phase-appropriate potency assay requirements from first in human, to pivotal, to commercial stages of a product for both vector and cellular drug product
Synopsis
- Factors to consider in potency strategy of early phase programs when balancing fast timelines with right first time
- Transition to GMP QC analytical potency methods in pivotal and commercial stages and strategies for method lifecycle management
- Utilization and choice of reporter genes as a functional bioassay and demonstration of MoA relevance
- Method development considerations for accuracy, precision and QC friendliness (eg. relative potency) as well as method performance characteristics (eg. specificity, linearity, accuracy, precision).
10:30 am Audience Discussion: The Automated Future for Potency
Synopsis
- Discussing the future scope for potency assay development platforms
- Minimizing the risk of human error when analyzing assay result
- Advancing technology in assay development whilst minimizing cost
11:00 am Reaction Biology Partner Presentation
11:15 am Morning Refreshments & Networking
Exploring the Varying Approaches to Potency Assay Design with a Thorough Validation of the Method
11:45 am Wielding Potency Assays in Early Clinical Development
Synopsis
- The utility of potency in stability assessments
- CDMO qualification for early-stage trials
- Comparability of potency data between laboratories
12:15 pm Implementing Potency Assay with Platform Approach across CAR T Cell Products
Synopsis
- Considerations for potency assay design and choice of analysis model
- Leverage DOE to test and potentially optimize assay robustness
- Planning ahead: retro-planning for reference material and critical reagents
12:45 pm
Matrix Approach to CART Potency Assessment. How do I test thee? Let me count the ways.
VIRTUAL
Synopsis
- Working definition of ‘potency’ for CART ‘Precedent’ for CART potency assessment – single point assessment of IFNg
- Revision of approach to “full-curve relative potency analyses”
- Alternative CART responses/activities to harness as potency measurements Proliferation
- Target cell cytotoxicity (potentially more MoA reflective)
- Not enough data to recommend one response measurement over the other
1:15 pm Lunch & Networking
Communicating Effectively Between the Roles Across Process & Analytical Development
2:15 pm Osteogenic Potency Assay, Reproducibility from the Ground Up
Synopsis
- The quest for osteogenic potency assay biomarkers
- Measurements and microenvironments
- Reproducibility across two independent laboratories
- Roadmap for improvements
2:45 pm Spotlighting the Mechanisms of Action of a Therapeutic from R&D to Assist Potency Assay Design
Synopsis
- Developing an understanding of biological functions of cell therapies
- Translating animal model and preclinical data into the theory behind potency assay design
- Tackling the multi-modal nature of cell therapies and dealing with the breadth of mechanism of action
3:15 pm Generating Potency Assays to Achieve a QC-Friendly Standard
Synopsis
- Creating a streamlined approach to potency assay transfer which is understood across varying disciplines
- Understanding what makes a potency assay QC-friendly
- Relating the signals between the clinic and QC
3:45 pm Reviewing Advised Strategy of Technology Transfer to Smooth the Interface with the CRO World
Synopsis
- Successfully transferring with a reliance on expertly designed processes and experiments
- Communicating with clarity to the CRO to transfer technology with confidence in the procedure
- Following fundamental documentation protocol which is fully reviewed to make the tech transfer water tight
4:20 pm Chair’s Closing Remarks
4:30 pm Close of Summit
