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.
Sponsor updated
2020 PROGRAMS
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Emerging Indications for Therapeutic Antibodies
Immunogenicity Case Studies and Clinical Management
Improving Immunotherapy Efficacy and Safety
Engineering Antibody-Drug Conjugates
Gene Therapy: Advancing from Bench to Clinic
Immunogenicity Assessment and Regulatory Approval of Biologics
Advancing Bispecific Antibodies and Combination Therapy to the Clinic
Optimizing Bioassays for Biologics
Clinical Progress of Antibody-Drug Conjugates
Characterization for Novel Biotherapeutics
Cell and Gene Therapy Analytics
Engineering Bispecific Antibodies
Protein Expression System Engineering