Drug Development Strategy in the United States: An Industrial View of DMPK

Drug discovery and development is an exciting and complex process that begins with target identification and ends with regulatory approval, launch and product life-cycle management. Along this 10+ year journey, drug metabolism and pharmacokinetics (DMPK) is vital in characterizing the absorption, disposition, metabolism and excretion (ADME) of the drug. Over the past 30 years, DMPK had grown from a relatively qualitative science providing a general description of a drug’s excretion pathways and metabolism, to a robust, integrative and quantitative discipline addressing drug interactions and ADME of complex molecules (1). This transformation has occurred through disruptive advances in bioanalytical and imaging technologies, and software to support extensive modeling and simulations exercises. The integration of these technologies with advances in our understanding of the fundamental biological process underpinning the ADME of new chemical entities has enabled the DMPK field to make significant contributions to drug development and discovery. This plenary presentation will highlight the evolution of the DMPK discipline through several case studies.