Bioassays are a critical component of biologics drug discovery and development. With increasingly complex biologic modalities coming to market, including those with multiple mechanisms, accurate biological measurements are crucial. Cambridge Healthtech Institute’s Third Annual Optimizing Bioassays for Biologics will showcase strategies for biologics with multiple modes of action while bridging two perspectives on bioassay development: biology and statistics. At this event, industry leaders will showcase strategies for assay selection, validation, transfer, and maintenance, with an emphasis on molecules with complex mechanisms. Health authorities will weigh in on new guidelines as well as provide insight into what they consider a well-characterized biologic. Finally, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.
Who should attend: Optimizing Bioassays for Biologics will bring together key individuals from bioanalytical R&D, cell and antibody engineering, immunology, pharmacology, and preclinical and clinical development.
Back to the Future, Envisioning the Next Generation Bioassay Development
Ray Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb
Evaluating Technologies for Anti-Drug Antibody Isotyping Assays
LiNa Loo, Ph.D., Senior Scientist, Bioanalytical Development, Merck
Analytic Tools to Characterize a Novel Lentivector-Based Cancer Vaccine
Brenna Kelley-Clark, Ph.D., Scientist, Immune Design Corp.
Bioassay Development for Bispecific Antibodies: A Different Ball Game
Piyush M. Vyas, Ph.D, Research Scientist, Bioassay Development, Eli Lilly and Company
Regulated ADC Bioanalysis Using Ligand Binding Assays: Challenges and Strategies
Seema Kumar, Ph.D., Principal Scientist, Pfizer, Inc.
Development of a Novel Cell Line for Evaluating the Potency of a Humanized Monoclonal Antibody
Laura Geagan, Staff Scientist, Genzyme
Transfer and Validation of a Cell-Based Neutralizing Antibody (NAb) Assay to a CRO
Florence Guilhot, Ph.D., Head, Translational Pharmacology Lab, NovImmune SA
Leveraging Advanced Liquid Dispensers, High Density Plates and Multi-Dimensional Optimization to Accelerate Bioassay Nab 96-Well Development
John M. Lehrach, Research Scientist, Bristol-Meyers Squibb