Immunogenicity Summit
Immunogenicity and Bioassay Summit


 Cambridge Healthtech Institute’s Fourth Annual
Optimizing Bioassays for Biologics
Merging Biology and Statistics for Successful Biological Assay Development

   October 27-28, 2016 | Hyatt Regency Baltimore | Baltimore, Maryland
Part of CHI's Immunogenicity and Bioassay Summit 2016

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 Fourth Annual Optimizing Bioassays for Biologics conference 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.

Preliminary Agenda


WORKING WITH MUTLI-SPECIFIC ANTIBODIES:
ADCs, BISPECIFICS, AND BEYOND

Two Case Studies: Picking the Best Potency Assay for a Bispecific Antibody

Peter Day, Ph.D., Scientist, Genentech

A High Throughput Platform for the Quantification of the Potency of Multifunctional Biologics

Michael Tovey, Ph.D., INSERM Director, Research, Laboratory of Biotechnology & Applied Pharmacology, Ecole Normale Supérieure de Cachan


ASSAY BRIDGING, TRANSFER AND VALIDATION

Essentials in Bioassay Design, Relative Potency Determination and Validation

Thomas Little, Ph.D., President, Bioassay Sciences, Thomas A. Little Consulting

Binding Assay as a Surrogate Assay for Functional Assay in Lot Release and Stability Testing: A Case Study

Ravish Patel, Ph.D, Scientist, Analytical Development Lab, EPR Centre for Cancer Research & Bioinformatics Pvt. Ltd. (A Vitane Group Company)


STATISTICAL TOOLS FOR BIOASSAYS

Using Simulation to Derive Acceptance Criteria for Parallelism Tests in Bioassays

Perceval Sondag, Senior Statistician, Non Clinical Statistics, Arlenda

Good Bioassay Designs: Practical, Statistically Sound, and Ready for DOE

David Lansky, Ph.D., President, Precision Bioassay, Inc

 

DESIGN-OF-EXPERIMENT IN SUPPORT OF ANTIBODY PRODUCT DEVELOPMENT

Accelerating the Speed of Optimization and Validation through Design of Experiments

Martin Kane, Managing Data Scientist, Statistical and Data Sciences, Exponent




For more details on the conference, please contact:
Samantha Drinkwater
Senior Conference Director
Cambridge Healthtech Institute
Tel: 781-972-5461
Email: sdrinkwater@healthtech.com

For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute 
Tel: 781-972-5412
Email: cbenton@healthtech.com

For media and association partnerships, please
contact:

James Prudhomme
Senior Marketing Manager
Tel: 781-972-5472
Email: jprudhomme@healthtech.com

Register Today!


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