DMPK / ADME and Clinical Pharmacology

Understanding how a drug moves through the body—its absorption, distribution, metabolism, and excretion—is the scientific backbone that transforms discovery candidates into clinical therapies. DMPK / ADME & Clinical Pharmacology integrates experimental, computational, and translational knowledge to explain drug exposure, variability, and response across populations. This session highlights the evolving science of predictive pharmacokinetics and pharmacodynamics, bridging laboratory findings to human outcomes. Researchers will gain insights into in vitro–in vivo extrapolation (IVIVE), transporter characterization, bioactivation pathways, and population modeling tools that support dose justification and regulatory decision-making. It explores how advanced modeling techniques such as PBPK, QSP, and population PK enable precision dosing, allowing teams to anticipate variability in pediatrics, geriatrics, or patients with renal or hepatic impairment. The session also focuses on integrating safety and efficacy data, supporting risk–benefit assessments and early identification of liabilities.

A key feature of this track is its emphasis on translational efficiency—how preclinical studies inform first-in-human trials, and how clinical pharmacology closes the loop by refining exposure–response relationships. Participants will learn to interpret bioavailability and bioequivalence data, optimize sampling strategies, and apply exposure metrics to regulatory submissions. This is also a vital forum for understanding how DMPK scientists collaborate with toxicologists, formulation experts, and clinicians to design rational trials that minimize variability and maximize predictive power.

In the age of automation and AI, the session underscores the importance of integrated data systems and model-informed drug development (MIDD). Professionals attending a Pharma Conference can expect to explore regulatory expectations for model qualification and validation, as well as case studies where data-driven decisions reduced attrition and streamlined approvals. Core themes in pharmacokinetics and pharmacodynamics are complemented by real-world evidence and biomarker-driven insights that improve dosing strategies and patient outcomes.

Whether you are developing small molecules, biologics, or advanced modalities, this track offers the essential framework for building a quantitative understanding of drug behavior. From early ADME screening and metabolite identification to clinical bridging studies, it provides the analytical and computational foundation for safe, effective, and reproducible therapies across all phases of development.