AAPS Webinar: Advancing Novel Therapeutics with Innovative DMPK Strategies in Metabolism and Bioanalysis

Webinars Overview

As healthcare continues to evolve, novel drug modalities such as oligonucleotides, peptides, and antibody-drug conjugates (ADCs) offer transformative potential. Despite their promise, these molecules present significant DMPK challenges in development due to their complex structures and unique mechanisms of action. This webinar will explore essential aspects of in vitro metabolism studies and bioanalytical strategies critical for the successful development and optimization of these therapies.

Participants will gain insights into the metabolic pathways specific to each molecule type, including the nuclease-driven oligonucleotide degradation, protease-mediated peptide hydrolysis, and ADC dual-metabolism. Discover how to strategically apply in vitro systems—hepatocytes, liver S9, lysosomes, plasma, and whole blood—to predict in vivo clearance, and provide critical insights for optimizing molecule design, enhancing stability, and ensuring safety.

Moreover, the webinar will address the complexities of ADC bioanalysis, including innovative strategies for handling bispecific antibodies and dual payloads. Attendees will gain insights into the comprehensive bioanalysis for ADC research, integrating LBA, LC/MS, and hybrid LBA-LC/MS for the evaluation of total antibody, conjugated antibody, free payload, conjugated payload, major metabolites and MetID, immunogenicity, and drug-to-antibody ratio (DAR). Through case studies and practical examples, this session aims to equip researchers with the knowledge to enhance   therapeutic design, stability, and efficacy.

The webinar will also introduce a new book authored by WuXi AppTec DMPK, Drug Metabolism and Pharmacokinetics: Frontiers, Strategies, and Applications, which expands on the topics discussed in the webinar and provides a deeper dive into the challenges and advancements in DMPK research for novel therapeutics.

Learning Objectives:

1. Understand the metabolic properties and research strategies for novel therapeutics, and evaluate how metabolism studies drive critical decisions.

2. Evaluate which in vitro systems best predict in vivo metabolic stability for these novel modalities.

3. Learn about integrated bioanalytical approaches and advanced techniques for the analysis of ADCs, including bispecific antibodies and dual payloads.