BUZZ Sessions

MONDAY, JANUARY 20
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 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

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