Cambridge Healthtech Institute’s 6th Annual

Optimizing Bioassays for Biologics

Case Studies Demonstrating Successful Bioassay Development

May 7-8, 2020

New therapeutic modalities, including cell & gene therapies, immunotherapies, and antibody therapies, continue to push the limit on bioassay development and implementation. New formats present challenges including determining what reference materials to use and how to validate the assay. Standards are advancing, but questions remain around the regulatory framework for assays. At the 6th Annual Optimizing Bioassays for Biologics, bioassay experts will address the top challenges in bioassay design including lifecycle management, validation, assay bridging, standards, and developing reference materials. Case studies and best practices for handling the most common issues in biological assay design will be presented with a focus on cell & gene therapies.

Preliminary Agenda

DESIGNING BIOASSAYS FOR CELL & GENE THERAPIES

Essentials in Bioassay Design for Gene and Cell Therapy

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

From Therapeutic Antibodies to Genomic Medicines: The Challenge of Developing Bioassays Reflecting the Drug’s MOA

Valeria Runza, PhD, Head, Functional Characterization, Large Molecules Research, Pharma Research and Early Development (pRED), Roche Diagnostics GmbH

Measurement Assurance, Control Strategies and Documentary Standards for the Development of Bioassays for Cell Therapy

Sumona Sarkar, PhD, Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, National Institute of Standards and Technology

EMERGING MODALITIES

Bioassay Strategies for Innovative Molecules

Natalia Kozhemyakina, Head, Bioassay Department, BIOCAD

STANDARDS AND REGULATORY CONSIDERATIONS

Principles and Practices for Bioassay Standards

Timothy Schofield, Owner and Consultant, CMC Sciences, LLC

PANEL DISCUSSION: Standards and Regulatory

Panelists: Steven Walfish, MBA, Principal Scientific Liaison, USP
Timothy Schofield, Owner and Consultant, CMC Sciences, LLC

CONSIDERATIONS FOR BIOASSAY DEVELOPMENT

Statistical Model Selection Using USP <1034>

Steven Walfish, MBA, Principal Scientific Liaison, USP

Uh-Oh, Our Primary Standard Isn’t Stable, What Do We Do Now?

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

Critical Reagents Characterization Strategy to Support Biologics/Vaccines Projects at Regulated Bioanalysis

Kun Yang, PhD, Associate Principal Scientist, PPDM, Merck

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