Bioanalytics
Mark Arnold, PhD
Owner and Principal
Bioanalytical Solution Integration
Westampton, New Jersey
Faye Vazvaei, M.S.
Executive Director, Regulated Pharmacokinetics Bioanalytical Lead
Merck & Co., Inc.
North Wales, Pennsylvania
The landscape of drug development is rapidly evolving—not just in molecular structures and cell types, but also in diseases, delivery technologies, and approaches to evaluating safety and efficacy. Bioanalysis plays a critical role in assessing target engagement, immunogenicity, pharmacokinetics, and pharmacodynamics, as well as in clinical laboratories supporting clinical trials, in the generation of reliable data based on sound scientific principles essential for regulatory review and approval. Regulatory bodies, as primary consumers of bioanalytical data, provide laws, guidelines, and reflection papers to ensure consistency and reliability of that data. A particularly significant recent development is the FDA’s acceptance of Novel Alternative Methodologies, reshaping expectations for data integrity and methodology standards.
Beyond regulatory shifts, bioanalysis faces additional transformative factors: emerging drug modalities, innovative delivery formulations, new disease targets, decentralized sample collection, AI-driven applications, and an increasing reliance on biomarkers, to name a few. Navigating these changes requires agile, forward-thinking bioanalytical scientists dedicated to advancing new therapies for patients.
This presentation will explore these evolving dynamics and highlight the pivotal role of bioanalysis in shaping the future of drug development.