Pre-Conference Workshop Day

Wednesday May, 31 2023| Boston, MA

7:30 am
Registration & Coffee Network

Cell Characterization Track

8:30 am Workshop A: Outlining Clear & Strategic Motivations for Cell Characterization to Ensure Transparency with the Desired Outcome

  • Emily Lowe Senior Director Analytical Sciences, Appia Bio


  • Determining the ‘why’ behind cell characterization
  • Understanding what you are striving to characterize within your cell population
  • Considering potency assay development when characterizing a cell population

Revolutionizing Approaches to Potency Track

8:30 am Workshop B: Gain, No Pain – Cell Therapy Potency Assay Development


  • Highlighting the need for potency assays across cell therapeutics to assist smooth process development Rethinking the attitude to assay development to prioritizing potency assays as a fundamental component of drug development
  • Navigating a clear path to potency assay development success to maximize clinical results

10:30 am
Morning Break

11:00 am Workshop C: Developing a Time Efficient & Cost Effective Method of Characterizing Cells Prior to Potency Assay Development


  • Outlining common mistakes across the cell therapy industry in relation to funding spent on cell characterization
  • Minimizing time spent on cell characterization whilst producing results of paramount importance to process development
  • Adopting good habits across cell characterization from early stage of development to reduce time and money spent unnecessarily 

11:00 am Workshop D: Adopting an Early Planning Approach to Cell Therapy Potency Assay Development

  • Mike Sadick Senior Director - Chemistry, Manufacturing & Control, Analytical Development, Precision Biosciences


  • Identifying the necessary steps required to maximize success in regulatory approval of the potency assay Following a scalable approach to potency assay design to adapt to product growth
  • Discovering cost effective methods of potency assay design to assist companies in their infancy 

1:00 pm
Lunch Break

2:00 pm Workshop E: Leveraging Characterization Data to Understand which Elements of Potency Assays are Predictive


  • Deconstructing the benefit and potential of characterization data
  • Exploring how results obtained from characterization can be optimally applied to potency assay analysis Developing a greater understanding of the potency assay through parallel analysis with cell characterization 

2:00 pm Workshop F: Platforms & Approaches for Enabling Translational Science with a Case Study in Non-Invasively Predicting Potency, Identity, & Safety of a Tissue Engineered Therapy for Macular Degeneration

  • Nathan Hotaling Senior Data Scientist, National Institute of Health Science


  • Improving the robustness, efficiency, and replicability of traditional and machine/deep learning analysis pipelines
  • Interoperable Computational Tool standard for multi-institute collaboration
  • iPSC derived tissue engineered scaffold 

4:00 pm
End of Pre-Conference Workshop Day