Day Two Agenda
7:30am - 4:40pm | Boston, MA
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7:30 am Registration Open & Coffee Networking
8:20 am Chair’s Opening Remarks
Improving Established Methods & Exploring Novel Technologies to Streamline Analytics
8:30 am Process Analytical Utility of Raman Spectroscopy for the Manufacturing of Cells for Therapy
Synopsis
- Great advances in laser technology and data analytics have increased the potential for spectroscopy to be used as process analytical technology
- Cell composition changes measured by Raman micro-spectroscopy distinguish stem cells from their differentiated progeny, even the accumulation of insulin in cells to treat diabetes
- Information-rich, non-invasive spectroscopic technologies should complement conventional methods to increase quality assurance
9:00 am Leveraging Multiplexed PCR for the Assessment of Cell Product Identity
Synopsis
- Measuring specific genes to identify your cell product
- Multiplexing assays to reduce time and improve efficiency
- Developing a workflow for the assay that allows it to be easily transferred for use in other cell therapy products
9:30 am Flow Cytometry-Based Analysis of Genomic Copy Numbers and Nanometer-Sized Gene Delivery Systems
Synopsis
- Developing a flow cytometry method for genomic copy measurements of single cells from viral copy number (VCN) reference cell lines
- Extraction, characterization, and measurement of extracellular vesicles (EV) and their cargo
- Analysis of Lentiviral particles using flow cytometry
10:00 am Morning Break & Networking
Pre-IND & Early Clinical Development
Chair: TBC
Chair: TBC
Starting with the End-in-Mind: Considerations for Raw & Starting Material Analysis
11:00 am Quality Considerations the Starting Material for Cell-Based Therapies
Synopsis
- Discussing contributing factors to the cell starting material variability
- Conducting exhaustive starting material characterization to ensure consistent starting material during product development
- Ensuring cellular starting material quality and consistency by establishing a robust quality management system
11:30 am Panel Discussion: Analysis & Selection of Raw Materials for the Development of Cellular Therapeutics
Synopsis
- What raw material attributes should we be measuring to prevent issues during later-stage manufacturing?
- How do we best meet the required quality to ensure consistency in manufacturing, quality, and safety?
Clinical Development & Commercialization
Chair: Nathan Majewski, Associate Director, Cell Therapy Analytical Development, Bristol Myers Squibb
Chair: Nathan Majewski, Associate Director, Cell Therapy Analytical Development, Bristol Myers Squibb
Scaling Up from Clinical Development for Commercialization & Preparing for Release
11:00 am Creating a Roadmap to the Commercial Success of Cellular Therapeutics
Synopsis
- Exploring how to approach release testing in late stage trials, to prepare for commercialization
- Outlining lessons learned from the commercialization of autologous cell therapies
- Navigating different regulatory environments to file in different jurisdictions
11:30 am Panel Discussion: Developing Assays Suitable for Release Testing
Synopsis
- What is the best strategy to minimise panels for release?
- Are there certain assays that should be removed
- How do we minimise release testing to reduce chances of method failure, while ensure the product is still safe and efficacious?
12:00 pm Lunch Break & Networking
Optimizing Early Stage Analytics to Bolster Speed to IND Submission & Phase 1 Launch
1:00 pm
Understanding the Regulatory Requirements for IND-Testing
Synopsis
- Discussing phase-appropriate analytical methods
- Outlining the fundamental considerations for submitting an IND-application to obtain seamless acceptance
- Sharing experience and advice regarding common shortfalls
1:30 pm Correlating Early Stage Product Analytics with Phase I Clinical Outcomes
Synopsis
- Combining data sets to maximize product and process understanding
- A method analysis that can provide insight even with high patient-to-patient variability
- Selecting analytic targets for future submissions
Evaluating Analytics During Manufacturing & Dealing with Process Changes
1:00 pm Monitoring In-Process Analytics for Successful Process Optimization & Manufacturing
Synopsis
- Highlighting the importance of in-process controls to ensure a consistent drug product
- Providing information on critical quality attributes (CQAs) throughout the manufacturing process and QC release testing
- Outlining key features that make an instrument appropriate for in-process PAT
1:30 pm Developing a Robust Process Control Strategy in Tandem with Appropriate Analytical Testing
Synopsis
- Alignment of Critical Quality Attributes to the Process control and analytical testing strategy
- Addressing how analytical development and quality control teams should best to deal with process development changes and vice versa
- Outlining an example where analytical methods had to evolve in tandem with process improvements
2:00 pm Afternoon Break & Poster Session
Synopsis
Don’t forget to check out the poster submissions and the jobs board!
Share Ideas to Learn from Others to Streamline Analytical Development
3:00 pm Roundtable Discussion 1: Exploring Best-in-Class Life Cycle Management of Assays
Synopsis
- Discussing the importance of phase appropriate testing
- Sharing methods to introduce new assays and removing those which aren’t relevant
- Sharing experience with scientific advisory meetings as a mechanism to implement these changes
3:30 pm Roundtable Discussion 2: Optimizing Cell Growth Medium to Support All Aspects of Analytical & Process Development
Synopsis
- How do we select growth media, and how do we justify changes in growth media? What are the subsequent analytical considerations?
- Discussing the role of cell culture medium on cellular interactions, thus impacting cell function
De-Risking the Final Formulation Step in Manufacturing with Improved Analytics
4:00 pm Developing Analytical Methods to Test for Cell Viability & Potency Post-Thaw
Synopsis
- Designing and developing assays to test for cell potency
- Utilizing cryopreservation to store cells for longer-term
- Ensuring the integrity of the final cell product remains intact with results showing high efficacy, viability and potency post-thaw