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

  • Peter Velazquez Associate Director - Analytical Development, Poseida Therapeutics


  • 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

  • Simina Popa Associate Director - Scientific, Bristol Myers Squibb


  • 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

  • Jorge Burns Assistant Professor, University of Ferrara


  • 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

  • Patrick Maeder Head of Assay Development and Validation at Bioassay GmbH, Reaction Biology

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


  • 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

  • Xenia Peluffo Naj Principal Scientist, Associate Director Analytical Development, Cellectis


  • 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.


  • Michael Sadick Senior Director - Chemistry, Manufacturing & Controls Analytical Development, Precision BioSciences


  • 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

  • Jorge Burns Assistant Professor, University of Ferrara


  • 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

  • Jasmin Kristianto Senior Scientist - Cell Based Assay & Analytical Development, Sana Biotechnology


  • 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

  • Hayden Ko Scientist, Analytical Development, Arsenal Biosciences


  • 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

  • Alex Santos Regulatory Scientist, Voisin Consulting Life Sciences


  • 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