MONDAY, JANUARY 20
3:15 - 4:30 PM
To see discussion table topics for the Friday BuzZ Sessions with Continental Breakfast featuring pipeline topic experts (January 24 at 8:00 - 9:00 am), please click here.
Discussion Table Topics
Room: Sapphire & Aqua Foyers
Table 1: Biotherapeutic Immunogenicity Risk Mitigation
Karl Griswold, PhD, Associate Professor, Engineering, Dartmouth; CEO, Stealth Biologics, LLC
- Where? Under what circumstances is biotherapeutic immunogenicity higher vs. lower risk?
- When? Considering immunogenicity risk early vs. late in the drug development process
- How? Strengths and limitations of preclinical immunogenicity risk assessment tools, and strategies for “deimmunizing” high-risk drug candidates
- Who? Participant discussion of firsthand experiences with biotherapeutic immunogenicity, assessment, and mitigation
Table 2: Improving CAR T Cell Therapy in Solid Tumors
Mitchell Ho, PhD, Senior Investigator, National Cancer Institute, NIH
- Targets in solid tumors
- Engineering better CARs
- Combination therapy
Table 3: Next-Generation Antibody-Drug Conjugates: What Are the Features Needed to Improve the Therapeutic Index?
Qing Li, PhD, Scientist, Antibody Discovery & Protein Engineering, AstraZeneca
- What are the features of current successful ADCs?
- Why do so many ADCs fail? Bad targets? Bad payloads?
- How can we improve ADCs: antibody binder, bioconjugation, linker, warhead, stability, PK?
- Combination of ADCs with immuno-oncology
Table 4: Accelerating ADCs from Discovery to Clinical Development
Ian Schwartz, Global Technology Consultant, Bioconjugation, Sartorius Stedim North America, Inc.
- Challenges being encountered
- Platforms for process development and manufacturing
- Strategies for reaction-related impurity removal
Table 5: Focusing on iPSC-Derived Therapies
Jiwu Wang, PhD, CEO and President, Allele Biotech
- How did the industry see iPSC-derived pancreatic beta cells as therapy for diabetes?
- Will MSC manufacturing from iPSC change the landscape of thousands of MSC trials?
- What are the effects of mixing differentiating cells with 3D material during organoid formation?
Table 6: Gene Therapy Formulations
Tanvir Tabish, MSc, Head of Formulation Development, Formulation, Fill and Finish, Takeda
- The future of viral-based gene therapy formulation development
- The use of non-viral vectors in gene therapy application
- Gene therapy vs. cell therapy; synergy or competition
Table 7: Current Challenges in Biologic Product Development; Novel Modality Product Development
Jainik Panchal, PhD, Associate Principal Scientist, Sterile Formulation Sciences, Merck
- Modality-specific analytical challenges
- Mechanistic degradation pathways for novel modalities
- TPP considerations for novel modality
- Regulatory challenges around product development
Table 8: How Can the Generally Accepted Specification that Protein Therapeutics Be 95% Monomer at the End of Shelf Life Be Applied to Other Types of Biotherapeutics?
David Hayes, PhD, Biophysics Consultant, International Solidarity of Scientists
- Where did the 95% monomer specification come from and what evidence and argument lead to the conclusion that it is an appropriate specification?
- With significant evidence that chemical modification is a common cause of aggregation, is it wise to try to increase yield by “disaggregating” biotherapeutics?
- Are we ready to identify a generally accepted specification for full and empty AAV capsids?
Table 9: “Big Data” Real-Life Applications
Ruojia Li, PhD, Principal Scientist, Statistics Team Lead, Biologics Development, Bristol-Myers Squibb
- Successful and unsuccessful case studies of big data applications in machine learning and artificial intelligence for biologics and gene/cell therapy
- Tools for analysis of big data
- IT infrastructure to manage data architecture and security
- Big data integration (e.g., consensus across -omics data analyses)
Table 10: How to Choose a Suitable Expression System for Your Product?
Johannes Buyel, Dr. rer. nat., Dr-Ing, Head, Bioprocess Engineering, Fraunhofer Institute for Molecular Biology and Applied Ecology IME
- Taking the products’ perspective
- Taking the CFO’s perspective
- Taking the regulatory perspective
- Other stakeholder perspectives
Table 11: Approaches to Protein Purification and Characterisation
Balaji Somasundaram, PhD, Strategy and Operations Manager, UQ Protein Expression Facility, The University of Queensland
- Factors to consider at the start of a project to design a suitable purification process
- Purification process scale-up considerations
- Importance of protein characterisation at every step of protein production