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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: