The PK in drug discovery course is an interactive course focussing on the concepts and applications of drug metabolism and pharmacokinetics to molecule design, selection and decision making in the pre-IND phase. The course is currently focussed around small molecules but many of the principles and content can be applied more widely.

The course covers PK in detail but with content extended to cover factors that influence PK properties in molecule design and how PK integrates and drives decisions with other aspects of DMPK, ADME and related disciplines. A core concept running throughout the course is on the role of the DMPK scientist as a discipline expert but also as a data integrator. The importance of molecule quality in the design and optimisation phase is enforced. This is followed by teaching the theory and the tactics for forecasting human PK and dose as a way of contextualising molecule properties and clinical potential. To ensure the discovery scientist has an appreciation of the later clinical and development requirements content includes a review of clinical pharmacology and PK in regulatory applications.

Delegates get to experience real life decisions in a virtual project team. Exercises in the selection of a lead series followed by a candidate molecule are experienced. Following prediction of the human PK and dose teams then assess the risk – benefit potential of the molecule to make a recommendation to proceed to Phase 1. Course content includes:

• Physicochemical properties and their influence on PK

• Basic pharmacokinetic principles required in compound evaluation: theory and calculations

• Theories and strategies for the application of PK in drug discovery projects

• Principles and application of PKPD in drug discovery

• Predicting human pharmacokinetics • ADME and toxicokinetics: principles and measurement

• Pharmacokinetics of metabolites: theory and important considerations

• Pharmacokinetics of biologics: theory and implications for PK and PKPD

• Clinical Pharmacology: importance and impact in drug development

• PK requirements for regulatory applications

Intended audience:
This course is intended for DMPK scientists wanting to gain further insight in to the role of DMPK in discovery projects and/or step up to become a DMPK Discovery project leader. It is recommended that delegates have some industrial experience and appreciation of DMPK as a broad discipline and of the discovery-development pathway. The course is also suitable for scientists from other disciplines (eg medicinal chemistry, biology, pharmacology, toxicology) wanting to learn more about the role of DMPK in the wider discovery project environment to enhance overall project leadership skills and decision making.