September 23-26, 2024,
Hynes Convention Center in Boston, USA
Biological Assays Track
Apply new technologies and regulatory strategies to improve CMC bioassay development and validation for platform and complex/ emerging biologics
QbD and DoE Approaches to Bioassay Development
Quality by Design in the Bioassay Development Lab
Kenneth R. Miller, Ph.D., Senior Scientist, Bioassay Development, Department of Analytical Sciences, Medimmune
Use of DoE Approaches for Potency Assay Development
Xuan Gao, Ph.D., Scientist, Analytical Development and Quality Control – Biological Technologies, Genentech
A Case Study of Applying DOE and Automation into a Cell-based Neutralizing Antibody Assay
Weifeng Xu, Ph.D., Senior Research Investigator, Bristol-Myers Squibb
Lifecycle Management of Bioassays and Assay Changes to Commercial Products
Lifecycle Management for Bioassay Development and Validation
Steven Walfish, Principal Science & Standards Liaison, United States Pharmacopeia (USP)
Change or Replace? Lifecycle Management of Bioassays for Commercial Products
Wei Zhang, Ph.D., Principal Scientist, Analytical Development, Biogen
CMC Biological Assay Case Studies
MoA-reflective Bioassays for a Monoclonal Antibody Targeting a T Cell Co-Stimulatory Receptor
Ganesh Shankarling, Ph.D., Scientist, Molecular and Analytical Development, Bioassay Center of Excellence, Bristol-Myers Squibb
Development of a Murine Reporter Cell Line System to Support Potency Assays Targeting Immuno-Modulatory Receptors
Ray Zhang, Ph.D., Associate Principle Scientist, Biologics and Vaccines Analytical Development, Merck
Late Breaking Presentation
Bioassay Development for Biosimilars and Complex Molecules
Functional Assays for Similarity Assessment of Biosimilars
Rajani Srikakulam, Ph.D., Principal Scientist, Bioassay Development, Oncobiologics
Bioassays Empower Biologics Development
Patrick Liu, M.D., Ph.D., Senior Director and Global Head of Bioassays, Teva Pharmaceuticals, Inc.
Late Breaking Presentation
Method Bridging and Method Tech Transfer for Bioassays
Strategies for Bridging Late Phase Cell-Based Potency Assays
Amy Teale, Ph.D., Senior Analytical Scientist, Regeneron Pharmaceuticals
A Road Map for Addressing Changes on a Validated Reporter Gene Bioassay
Xin Li, Scientist II, Global Technical Operations, AstraZeneca
Potency Assays: Automation, Statistics & Critical Reagents
Scientific and Statistical Approaches for Developing Potency Assays for Bispecific Antibodies
Maroun Beyrouthy, Ph.D., Research Scientist, Bioassay Group, Eli Lilly and Company
Accelerating Potency Bioassay Delivery by Leveraging Automation and Cellular Assay Platforms
John Lehrach, Research Scientist, Leads Discovery & Optimization, Bristol-Myers Squibb
Strategies for Management of Critical Reagents Used in Potency Assays
Vineetha Jayasena, Ph.D., Principal Scientist, Amgen
Meet the Scientific Advisory Board:
- Souravi Ghosh, Ph.D., Senior Scientist Assay Innovation, Research & Clinical Bioanalytics, CSL Limited, Australia
- Guoying Jiang, Ph.D., Associate Scientist, Analytical Development and Quality Control,Genentech, Inc.
- Han Li, Principal Scientist, Bristol Myers Squibb
- Kenneth R. Miller, Ph.D., Senior Scientist, Bioassay Development, Department of Analytical Sciences, Medimmune
- Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts
- Pin Yee Wong, Associate Director, Analytical Development and Quality Control, Genentech
- Wei Zhang, Ph.D., Principal Scientist, Analytical Development, Biogen