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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
