Immunogenicity and Bioassay Summit

Optimizing Bioassays for Biologics

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.


ADVANCES IN BIOASSAY TECHNOLOGIES

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


POTENCY TESTING FOR GENE AND CELL THERAPIES

Analytic Tools to Characterize a Novel Lentivector-Based Cancer Vaccine

Brenna Kelley-Clark, Ph.D., Scientist, Immune Design Corp.


DEVELOPING ASSAYS FOR MULTIPLE MODES OF ACTION

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.


PROCESS COMPARABILITY AND CHARACTERIZATION

Development of a Novel Cell Line for Evaluating the Potency of a Humanized Monoclonal Antibody

Laura Geagan, Staff Scientist, Genzyme


BRIDGING STUDIES AND ASSAY TRANSFER

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

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 2014 Brochure Cover 

Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

2013 Speaker: Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefenseDivision, Emergent BioSolutions