Cambridge Healthtech Institute’s 5th Annual

Optimizing Bioassays for Biologics

Case Studies Demonstrating Successful Bioassay Development

April 11-12, 2019

 

As the bioassay field continues to move forward, challenges are evolving from new drug formats such as antibody therapies, cell therapy and gene therapy. There are numerous considerations to keep in mind during assay development such as lifecycle management and planning for lot release. At the Fifth Annual Optimizing Bioassays for Biologics, bioassay experts will address the top challenges in bioassay design including novel technologies, increasing complex mechanisms-of-action, regulation and the application of statistics in assay development. Case studies and best practices for handling the most common issues in biological assay design will be presented. Overall, this event will showcase ways to continue moving a biologic forward in the discovery pipeline.

Preliminary Agenda

REGULATION

Demystifying USP Bioassay Chapters

Steven Walfish, MBA, Principal Scientific Liaison, USP

BIOASSAYS FOR EMERGING MODALITIES

Presentation to be Announced

Emily Lowe, PhD, Senior Scientist, Analytical Sciences, Kite Pharma, a Gilead Company

Cytotoxicity Assay Development for CAR-T

Ashley Mullan, Scientist, Development, Analytical Sciences, MedImmune

ASSAY BRIDGING STRATEGIES

Statistical Approaches for Successful Assay Bridging

Perceval Sondag, Senior Manager, Statistics, PharmaLex

Analytical Bridging: How to Cross on the Wire Stretched Between Two Bioassay Methods? A Case Study

Gaël Debauve, PhD, Associate Director, Bioassay Development, Analytical Sciences for Biologics, UCB

BUILDING A BETTER BIOASSAY

Improving the Robustness of a Bioassay Through Outlier ID and Removal

Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting

Strategic Ways to Meet Bioassay Performance Requirements with Modular Design and Analyses

David Lansky, PhD, President, Precision Bioassay, Inc.

Strategies and Approaches for Building a Better Bioassay

Natalia Kozhemyakina, PhD, Head, Bioassay Laboratory, Analytical Development Department, BIOCAD

Optimization of a Complement Dependent Cytotoxicity Assay

Kristin Abrams, Scientist, Amgen, Inc.



* The program is subject to change without notice, due to unforeseen reason.

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