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Assessment of Drug Interactions in Drug Development
- Definitions of Drug Interactions
- Drug Metabolism
- Enzyme Inhibition and Induction
- Reaction Phenotyping
- Drug Interaction Study Design
- Transporter Interactions
- Drug Interactions Case Studies
Overview of the webinar
- Drug-drug interactions are a common problem and result in hospital admissions for medically important and even fatal adverse events.
- Drug-drug interactions can also cause partial or complete abolishment of treatment efficacy.
- The ageing population, where polypharmacy is more frequent, increases the likelihood of such interactions and underlines the importance of a scientifically sound understanding of the potential for drug-drug interactions for all new chemical entities.
- The potential for pharmacokinetic interactions between new medicinal products and already marketed drugs should be evaluated as most drug-drug interactions are pharmacokinetic in nature.
- During the assessment of drug interactions, both the effects of the medicinal product on other drugs as well as the effect of other drugs on the medicinal product should be investigated.
- The drug-drug interaction potential is usually investigated through in vitro studies followed by clinical studies. The results of interaction studies are used to predict a number of other interactions based on the mechanisms involved.
- Treatment recommendations are developed based on the clinical relevance of the interactions and the possibility to make dose adjustments or treatment monitoring.
- The webinar will provide the basic concepts of drug interactions and their use in drug development and will describe how drug interactions studies should be designed and how they have been used successfully by reviewing some case studies.
Who should attend?
- Medicinal Chemists
- R&D Scientists
- Preclinical Scientists
- Clinical Scientists
- Clinical Research Associates
Why should you attend?
- You will get a better understanding of the risk, evaluation, and interpretation of drug-drug interaction in drug development.
- You will learn the definitions and mechanisms responsible for drug interactions.
- You will learn which patients are at higher risk of experiencing drug interactions.
- You will learn how to design the in vitro and the clinical drug interaction studies to add value to your drug development program also in comparison with competitors.
- You will learn the difference between drug interactions mediated by metabolic enzymes and those mediated by transporters.
- You will learn how the assessment of drug interactions can streamline your drug development program in line with regulatory expectations.
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.