MONDAY, JANUARY 14
3:15 - 4:30 PM
Facilitated, small-group discussions. Interactive participation leads to problem-solving solutions and future collaborations around focused topics.
To see discussion table topics for the Friday BuzZ Sessions with Continental Breakfast featuring pipeline topic experts (January 18 at 8:00 - 9:00 am), please click here.
Discussion Table Topics
Recombinant Fusion Proteins for the Establishment of Immune Tolerance
Stephen D. Miller, PhD, Judy Gugenheim Research Professor, Director, Interdepartmental Immunobiology Center, Microbiology-Immunology, Northwestern University Medical School
- Which recombinant fusion proteins are in the pipeline for treatment of immune-mediated diseases via establishing tolerance?
- What are the major pathways that can be targeted for establishment of tolerance and enhancing the function of regulatory T cell networks?
Clinically Applicable Imaging of BBB Penetration by Peptides and Proteins
Miroslaw Janowski, MD, PhD, Associate Professor, Radiology, Johns Hopkins University
- Selection of imaging modality
- Methods of peptide and protein labeling
- Precision medicine through real-time image guidance
Genome Editing in Cell Line Generation
Filip Roudnicky, PhD, Senior Scientist, Disease Relevant Cellular Assays, F. Hoffmann-La Roche Ltd.
- Tools to generate modified cell lines
- Best practices for analysis
- Modeling disease using genetically modified cells
Solid Tumor Targets for CAR T Cell Therapy
Mitchell Ho, PhD, Senior Investigator, National Cancer Institute, NIH
- New or emerging targets in solid tumors
- Shared antigens vs. individual neoantigens
- How to find new targets: genomics, proteomics, glycomics, etc.
- Common cancers vs. rare cancers
Next-Gen Approaches for Solid Tumor Immunotherapy
Prasad S. Adusumilli, MD, Head, Solid Tumors Cell Therapy, Cellular Therapeutics Center (CTC), Memorial Sloan Kettering Cancer Center
- Combination immunotherapy for solid tumors
- CAR-T cell therapy for solid tumors
- Investigational models for human immunotherapy
- Solid tumor immune microenvironment
Process Intensification Strategies
Stefan R. Schmidt, PhD, MBA, Head, Operations (COO), BioAtrium AG
- Compressing process run times
- Continuous processing
- Combining unit operations
- Outsourcing of preparation efforts
- Cell bank to main reactor
- Automation
- PAT strategies
Favorite Approaches to Rationale Combination Discovery in Oncology Biologics
Alexander Bankovich, PhD, Senior Director, Late Stage Research, Abbvie Stemcentrx, LLC
- Mixed therapeutic modalities versus same modality and different targets
- Synergy that you can believe in
- Preclinical models that could predict outcome
- Diagnostic validation approach
- Considerations for preclinical assets and protocols
Is the Bystander Effect Good or Bad for ADCs?
Marc Damelin, PhD, Senior Director, Biology, Mersana Therapeutics, Inc.
- What is the evidence that a bystander effect enhances anti-tumor activity?
- What is the evidence that a bystander effect exacerbates toxicity? Is the impact observed in the context of specific toxicities, or is it general?
- What are the key considerations and experiments required to determine whether a bystander effect is desirable? Does it depend on payload mechanism, disease (e.g., tumor type), or any other factors?
Stability Challenges in Protein Formulation
Prakash Manikwar, PhD, Scientist II, MedImmune
- Aggregation characterization and stability attributes of ADCs and bispecific proteins
- Subvisible particle characterization of biologics
- Viscosity characterization and reduction of biologics
- Challenges to identify and develop new excipients for protein stabilization
- Correlation between biophysical (conformational and colloidal) properties and long-term stability of biologics
Host Cell Protein (HCP) Impurities in Biotherapeutics
Jichao (Jay) Kang, PhD, RAC, Director, Analytical Development, Amicus
- Setting HCP specification
- Analytical tools and orthogonal methods for host cell protein
- Case examples
High-Throughput Construct Generation and Expression
Chao-Guang Chen, PhD, Senior Scientist, Research Department, CSL Limited
- Cut-paste vs. ligation-independent cloning
- Individual cloning vs. pool cloning
- Strategy to reduce or eliminate cloning background
- Challenges with multi-gene cloning
- Plasmid DNA preparation for HTP expression
Engineering Cell-Based Production Hosts for Industrial Production
Bjørn Voldborg, MSc, Director, CHO Cell Line Development, The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark
- Which organisms can/cannot be engineered?
- What impact can engineered cells have?
- Can we engineer for production of completely novel products?
NEW: Strategic Outsourcing in Cutting-Edge Biologics Development
Michael Fiebig, PhD, Director, Products and Innovations, Absolute Antibody Ltd
- What drives developers to outsource?
- Is this the future or a fad; will development gradually be brought back in-house?
- What might drive that? What processes can be readily outsourced?
- Is there anything that should never be outsourced? What measures could CDMOs and CROs take to make themselves more useful for biologics developers?
In situ Bacterial Protein Secretion and Isolation
Tuck Seng Wong, PhD, Senior Lecturer, Chemical and Biological Engineering, University of Sheffield
- Intracellular protein production vs. extracellular protein production
- Bacterial secretion vs. bacterial disruption/lysis
- Native secretory machinery vs. engineered secretory machinery
- Periplasmic protein vs. extracellular protein
Optimizing Microbial-Based Production
Lisa Burdette, Laboratory for the Engineering of Membrane Proteins and Protein Membranes, Department of Chemical and Biomolecular Engineering, Northwestern University
- Current challenges in microbial production
- Emerging microbial platforms and applications
- Increasing yield