Workshop Overview
Workshop Trainer: Mr. Stefano Persiani
The primary objective of PK/PD modeling is the prediction
of the time course of the drug effect and its relation to
dose and exposure. PK/PD modeling has become a key
success factor in drug R&D. PK/PD represents and
extremely useful tool for the selection of drug candidates,
their optimization, and for maximal exploitation of early
clinical studies for an optimal design of pivotal Phase 3
trials. PK/PD relies on prior in vitro bioassays, animal, and
early clinical studies. PK/PD modeling is part of
pharmacometrics and can be based also on the
patho-physiological mechanisms and progression of the
disease to predict therapeutic effects.
This comprehensive and detailed two-day course
describes the PK/PD studies from an industrial perspective
to achieve a successful regulatory submission. The course
is intended for those that have a previous background in
PK/PD but also for those who wish to get an in-depth
training in PK/PD whilst not being specialists in the field.
The course will provide a review of the PK processes and of
PD studies from a pharmacological perspective. Preclinical
PK/PD studies including the role of radiolabelled studies
and the evaluation of pharmacologically active and/or toxic
metabolites and toxicokinetics will be described.
The dose-exposure-effects will be explained through
physiologically- and mechanism-based PK/PD modelling to
design first-in human and later clinical trials. Clockwise and
counterclockwise hysteresis as common forms of PK/PD
correlations will be covered as well as the use of
biomarkers to assess target occupancy and their
difference from surrogate endpoints. The application of
MRSD and MABEL approaches and microdosing as
regulatory requirements and tools for a correct design and
conduction of early clinical trials, will be explained.
Biological and advanced therapies are becoming more
important, and the course will provide an overview of
PK/PD studies for these new agents. The scientific
background, study design, and data interpretation for
population pharmacokinetics will be covered. Finally, the
course will describe how the potential for a NCE to exert
drug-drug interaction is assessed in pre- and clinical
development.
Attendance will provide an overview of the above topics
including temporal placement throughout the drug R&D
program. This will be done without excessive use of
mathematics. The course will provide trouble-shooting
strategies for all the main studies and will focus on the
critical aspect for a smooth conduction, interpretation, and
use of PK/PD for the successful selection and registration
of New Chemical and Biological Entities.