ブレイクアウトディスカッション

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8月15日（火） 10:45 - 11:30 AM

TABLE: The Indispensability of Gene Editing in Drug Discovery and Development
Moderator: Metewo S. Enuameh, PhD, Senior Scientist, Vector Core Cell Line Development, REGENXBIO, Inc.

How relevant are isogenic cell lines in drug discovery and development today?
What are the factors to consider in choosing a cell line for isogenic cell line development?
What are some strategies to evaluate long term stability of clones?
What new technologies can we employ to predict clone stability?

TABLE: Bioreactor Design and Optimization for Continuous Bioprocessing
Moderator: Jean-Francois P. Hamel, PhD, Lecturer, Chemical Engineering, Massachusetts Institute of Technology

Assessing microbial and animal cell benchtop bioreactors, designed for fed-batch or continuous applications (e.g., perfusion) and scale-down studies.
Choosing microfluidics and benchtop bioreactors (traditional and single use) for screening, optimization and process development.

TABLE: Transient Expression vs Stable (Pool) Cell Lines
Moderator: Stefan Schmidt, PhD, MBA, CEO, evitria AG

When to choose what mammalian expression system?
Effort, expression level, timelines, typical purposes, cost, scale, quality, development lifecycle
Pros and cons for the different approaches

TABLE: Formulation, Stability, Delivery, and Forced Degradation Studies
Moderator: Kruti Soni, PhD, Scientist, Technical Development, Biogen

Formulation
Stability for Gene Therapies
Forced Degradation
Device Selection

TABLE: Trends in CMC for Cell Therapies
Moderator: Scott R. Burger, Principal, Advanced Cell & Gene Therapy LLC

Trends in CMC
Tech transfer
Manufacturing

TABLE: Use of LC-MS as a Release Method for HCP
Moderator: Thomas Kofoed, PhD, Co-Founder & CEO, Alphalyse, Denmark

Why is there a need for LC-MS as a release method? What types of products/biologics would it be particularly relevant for?
What are the major challenges using LC-MS as release test? And how could these be overcome?
What will the new USP chapter and USP standards for HCP Analysis by Mass Spectrometry lead to?
What are relevant product release specifications CoA - total HCP amount?, individual amount of problematic HCP?, Amount of Top20 HCPs?
Should animal ethics be a concern? Would you choose LCMS instead of ELISA that requires immunization and use of experimental animals?

TABLE: HCP Detection, Analysis and Control
Moderator: Rosalind L. Ang, PhD, Associate Principal Scientist, Merck

Comparing a platform assay against a second assay (e.g., commercial kit) for relevance and prospective uses
Strategies for transitioning from a commercial kit to process-specific or platform assay (antibody coverage, bridging, phase appropriateness)
Immunoassays for commercial phase DS manufacturing
ELISA test results for individual HCPs on DS release specs

TABLE: Formulation Development, Bioprocessing, and Manufacturing of Vaccines
Moderator: Christopher P. Locher, PhD, Co-Founder & CEO, Biology, Versatope Therapeutics

Continuous manufacturing
Reducing costs for mRNA synthesis
Formulations for thermostability

8月16日（木） 9:30 - 10:30 AM

TABLE: Modeling Liquid-Liquid Mixing in Drug Product Process Development
Moderator: Robert Kuo, PhD, Assoc Principal Scientist, Sterile & Specialty Products, Merck

Critical inputs for creating a representative model
Extracting actionable data and insights from simulations
Validating results and impacting the process development outcome

TABLE: Steps Towards A Fully Automated Bioprocess
Moderator: Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)

Process integration a prerequisite for automation
What are the barriers for full automation?
Which sensors do we need?
Benefits of automation

TABLE: Manufacturing Cell and Gene Therapies
Moderator: Michael D. Jacobson, PhD, Managing Partner, Cambridge Biostrategy Associates LLC

Trends in commercializing cell and gene therapies
De-centralized versus centralized manufacturing
Pricing trends, reducing costs
New trends
in vivo CAR T engineering and delivery

TABLE: dsRNA in LNP-mRNA Vaccine Products
Moderator: Christina Schier, PhD, Senior Scientist, Merck & Co., Inc.

How do we measure dsRNA? - Current analytical methods.
What are the biological implications for dsRNA in vaccines?
What might the non-emergency dsRNA regulatory landscape look like?

TABLE: Accelerating Analytical Development of Novel Modalities: Challenges & Potential Solutions
Moderator: Xue (Shelly) Li, Associate Director, Biologics Development, Bristol Myers Squibb

Major challenges in CQA evaluation for novel modalities (e.g., AAV, FDC, Alternative-Format Molecules)
Limitations of conventional analytical tools for the analysis of novel modalities
Pros and Cons of new analytical technologies in the development of novel modalities
Health Authority’s perspective ― Is it possible to achieve both high speed and high quality?

TABLE: Technological Innovations to Accelerate Analytical Development
Moderator: Zhirui (Jerry) Lian, PhD, Senior Director, Eli Lilly and Company

Opportunities and challenges of high-resolution and high-throughput analytical methods (e.g., MAM, NMR etc.)
Automation: successful stories and lessons learned
Digital transformation: successful stories and lessons learned.
Future perspective of Machine learning/Artificial Intelligence in biotherapeutics development

TABLE: dsRNA in LNP-mRNA Vaccine Products
Moderator: Christina Schier, PhD, Senior Scientist, Merck & Co., Inc.