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Validity : 14th Apr'24 to 24th Apr'24
PK/PD Studies in Drug Discovery and Development
- Pharmacokinetics
- Pharmacodynamics
- Biomarkers
- Pharmacokinetic/Pharmacodynamic
- Case study
Overview of the webinar
- Pharmacokinetics (PK) describes the time course of drugs in the organism i.e. the processes that a drug undergoes after administration. PK, therefore, assesses the absorption, distribution, metabolism, and excretion of new chemical entities. In other words, what the body does to the drug.
- PK/PD is essential in drug discovery for target validation, optimization of lead compounds development, and compounds scaling to humans.
- Pharmacodynamics (PD) describes the relationship between drug concentration and pharmacological response (onset, intensity, and duration). In other words, what the drug does to the body.
- PK/PD is essential in pre- and clinical development to obtain a proof of mechanism (i.e. after administration, the drug is capable of reaching the intended target at sufficiently high concentrations).
- PK/PD assesses concentration-response and response-time relationships. The objective is to understand the relationship between dose and effect to predict therapeutic benefit or harm at any given dose in humans.
- PK/PD is essential in clinical development for dose selection and study design (target patient population, endpoints selection, safety monitoring).
- Drug discovery and development without the use of PK/PD is considered nowadays at a higher risk of failure. It is therefore important to understand the basics of PK/PD and how this can streamline the drug discovery and development programs.
Who should attend?
- R&D Scientists
- Medicinal Chemists
- Preclinical Scientists
- Clinical Scientists
- Clinical Research Associates
- Formulation Development
Why should you attend?
- To get a better understanding of how pharmacokinetics (PK) and pharmacodynamics (PD) are correlated and how these correlations can streamline the drug discovery and development programs.
- Investigation of the PK/PD correlations is extremely valuable during early drug discovery to fully interpret the pharmacological data in preclinical disease models and the safety signals observed during toxicological studies including the evaluation of the safety margins.
- During drug development, investigation of PK/PD correlations will support dose selection for clinical trials, target patient population and endpoint selection, comparison with competitors, and will help during the interpretation of drug safety and tolerability.
- The webinar will describe the basic concepts of PK/PD in drug discovery and development by reviewing drug exposure measurements, plasma protein binding, biomarkers, exposure-effect relationships.
- The webinar will examine the importance of dosing schedules and target engagement and problems in evaluating time-response relationships.
- You will understand how PK/PD adds significant value to study design in both the pre- and clinical setting and how this can increase the chance of success in drug discovery and development.
Faculty - Dr.Stefano Persiani
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. Dr. Persiani was later 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 as Scientific Director for Clinical Pharmacology. Dr. Persiani in his current role applies translational approaches from drug discovery to registration in several therapeutic areas. Dr. Persiani is a member of various international scientific societies, serves on the review board of numerous professional journals, and acts as an external expert for the European Commission on the 7th Framework Program, HORIZON 2020, Marie Sklodowska-Curie Individual Fellowship Program, and Innovative Medicine Initiative. He also acts as an external expert for the La Caixa Foundation (Spain) and for the Research Agency of the Check Republic.
Specialities: Drug and biopharmaceutical discovery and development; from pre-clinical to clinical Phase I, and IIa. Dr. Persiani gives courses and consults in the above fields at the University of Milan Bicocca, University of Chieti, University of Bologna, University of Rimini, Thomson Reuter, IIR, Life Sciences Strategy, Informa life sciences, Health Communication Network, Vision in Business, Pharmaceutical Training International, GRC Educators, Trainning.com, and MPG Media.