Translating Covalent Drug Candidates from Concept to Clinic: DMPK & Clinical Pharmacology Strategies for Patient Benefit
- Defining the critical DMPK and clinical pharmacology considerations needed to successfully translate covalent drug candidates from discovery into clinical development – spanning dose selection, regimen design, clearance prediction, and the exposure-response relationships unique to irreversible mechanisms
- Leveraging cross-industry insights from a multi-company consortium to identify common challenges and best practices in progressing covalent therapies, with a focus on overcoming bottlenecks in dose finding, safety assessment, warhead reactivity characterization, and clinical study design
- Establishing practical guidance for bridging preclinical and clinical decision-making – including the implications of endogenous protein binding, which studies are essential vs. avoidable, and how to optimize development strategy to maximize the likelihood of regulatory success and patient impact