Total Bioanalytical Support for Antibody-Drug Conjugates (ADCs)

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Antibody−drug conjugates (ADCs) typically contain a small molecule toxin (payload) linked to an antibody framework. The intent is to deliver the toxin in a targeted manner based on the specificity of the antibody, minimizing the amount of toxin needed and directing its effects to the proper cell(s). This combination of modalities, both small and large molecule, requires leveraging multiple bioanalytical tools to characterize the pharmacokinetics and immunogenicity of this class of drug. This webinar will provide an overview of the integrated bioanalysis of ADCs focusing on PK and immunogenicity including case studies and a live Q&A session.

About the Speakers

David A Johnson, Senior Director, DMPK, has over 20 years of experience implementing and managing preclinical drug discovery contract research services. In 2000, he joined BioAgilytix, establishing the Drug Metabolism group which is responsible for preclinical drug metabolism research and non-GLP discovery bioanalytical research.

Previously, David was the Drug Metabolism Product Development Manager for the Pharmazyme division of Immune Complex Corporation (CA, USA). Prior to Pharmazyme, he was a Research Assistant at Hybritech (CA, USA), where he developed methods to automate the radiolabeling of monoclonal antibodies for use in medical diagnostic kits.

Jason DelCarpini, Associate Director, Scientific Services, has worked in the field of regulated bioanalysis for over 20 years. He has extensive experience developing and validating assays for various modalities (ADCs, cell & gene therapies, enzyme replacement therapies, Fc-fusion proteins, muti-functional therapeutics and monoclonal antibodies). Jason also has experience working in both biopharmaceutical development and the CRO industries and is currently an Associate Director at BioAgilytix specializing in PK, ADA, and NAb assays.

Christina Strom, MS, Manager II, Christina Strom is a Bioanalytical Project Manager at BioAgilytix, where she started as a bench scientist in 2014. She develops immunoassays for ADA, NAb and PK analysis. She has a background in molecular science from 6 years as a researcher in the UNC School of Medicine (NC, USA) in a DNA repair lab. When not in the lab, she loves spending time on a beach with her husband, two sons and three dogs.

Jim McNally, PhD, Chief Scientific Officer, offers 20 years of experience in bioanalytical assay development and program leadership in pharmaceuticals and biotechnology. At BioAgilytix, he advises on emerging scientific developments and provides scientific and regulatory guidance. Prior to BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics (MA, USA), with previous roles at Genzyme (MA, USA), Pfizer (MA, USA), EMD Serono (MA, USA) and Shire (MA, USA).

Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and progression of biotherapeutics from research through clinical development. He has special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue.