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

  • Pete Cotter Associate Director, Analytical Development, Verve Therapeutics

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

  • James Piret Professor, Michael Smith Laboratories, The University of British Columbia

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

  • Sumeet Poudel Biologist, National Institute of Standards & Technology

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

Starting with the End-in-Mind: Considerations for Raw & Starting Material Analysis

11:00 am Quality Considerations the Starting Material for Cell-Based Therapies

  • Melba Marie Page Analytical Quality Control Laboratory Manager, Moffitt Cancer Center

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

  • Melba Marie Page Analytical Quality Control Laboratory Manager, Moffitt Cancer Center
  • Alice Lin Director, Analytical Science, Neogene Therapeutics
  • Shibani Mitra-Kaushik Head, Drug Product, Viral Vectors & Cell Bank Analytics, Cell Therapies , Takeda

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

Scaling Up from Clinical Development for Commercialization & Preparing for Release

11:00 am Creating a Roadmap to the Commercial Success of Cellular Therapeutics

  • Kyle Carter Director, Global Quality Control, Kite: A Gilead Company

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

  • Hadar Adams Principal Scientist, Atara Biotherapeutics
  • Jim Shaw Director, Analytical Development, Chimeric Therapeutics
  • Kyle Carter Director, Global Quality Control, Kite: A Gilead Company

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

  • Amnon Eylath Vice President, Head of Global Quality, Minovia Therapeutics

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

  • Kim Luu Head of Process & Analytical Development, Talaris Therapeutics

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

  • Anu Vasudevan Senior Scientist II, Analytical Development, Arsenal Bio

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

4:30 pm Chair’s Closing Remarks

  • Pete Cotter Associate Director, Analytical Development, Verve Therapeutics

4:40 pm End of Conference