The primary objective of Pharmacokinetic/Pharmacodynamic (PK/PD) modelling is the prediction of the time course of the drug effect and its relation to dose and exposure. PK/PD modelling has become a key success factor in drug research & development. PK/PD represents an 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 modelling is part of pharmacometrics and can be based also on the patho-physiological mechanisms and progression of the disease to predict therapeutic effects.
The PK/PD in Streamlining Drug Development Masterclass is a comprehensive and detailed two-day course which 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 and Clinical PK/PD studies including the role of radio labelled 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 counter-clockwise 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 an 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.
You want to understand the values of PK/PD studies in drug R&D from an industrial perspective.
You want to explore the optimal strategies to select, design, conduct and interpret the relevant preclinical and clinical PK/PD studies.
You want to assess the role of biomarkers in drug R&D and their optimal use for study design and outcome evaluation.
You want to understand the crucial aspects of the first in humans and other early clinical studies design, conduction, and interpretation including regulatory authorization.
You want to avoid failure of PK/PD studies conducted either in-house or contracted externally.
You want to understand the differences between small molecules and biological and advanced therapies as far as PK/PD are concerned.
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Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a post-doctoral fellowship in the Department of Pathology of the University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector with different managerial roles in drug R&D. Dr. Persiani is currently applying translational approaches from drug discovery to development and registration in several therapeutic areas. He is a member of various international scientific societies and serves on the review board of numerous professional journals. Dr. Persiani acts as an external expert evaluator for the European Commission on the 7th Framework Program, Maria Sklodowska-Curie Individual Fellowships, HORIZON 2020, and Innovative Medicine Initiative, and for several other government organizations where he evaluates and provides recommendations on applications requesting funding. Dr. Persiani has many years of teaching and training experience in several fields of Translational Sciences.
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