Assessment of Drug-drug Interactions in Drug Development
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 as Scientific Director for Clinical Pharmacology. Dr. Persiani in his current role applies translational approaches from drug discovery to development and registration in several therapeutic areas. Dr. Persiani 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. Dr. Persiani is also an expert evaluator for La Caixa Foundation where he evaluates and provides recommendations to the bank on applications requesting funding. Dr. Persiani is a faculty of Pharmaceutical Training International and Traininng.com where he provides training to pharmaceutical executives in several fields of Translational Sciences.
During drug development, the in vitro drug metabolism and drug transporter interaction studies should allow understanding the need for and the timing of clinical drug interaction studies. These in vitro studies should be completed before the product is administered to patients who are likely to take concomitant medications that could interact with the investigational drug. These studies should assess the effect of the investigational drug as a perpetrator on the marketed drugs that can be co-administered as victims. At the same time, these studies should assess the effect of the marketed drugs as perpetrators on the investigational drug as a victim. This information will also prevent patients from being unnecessarily excluded from any clinical study because of their concomitant medication use. Unnecessary restrictions on patient enrollment can result in clinical study populations that are not representative of the indicated patient population. Finally, inadequate evaluation of the drug interaction potential will negatively affect the ability to determine the benefits and risks of an investigational drug.
Patients frequently use more than one medication at a time.
Unanticipated, unrecognized, or mismanaged drug interactions are an important cause of morbidity and mortality associated with prescription
drug use and have occasionally caused the withdrawal of approved drugs
from the market. Clinically relevant drug interactions between an
investigational drugs and other drugs should, therefore, be assessed during
drug development using nonclinical and clinical assessment to obtain
The topics that will be discussed during the webinar include the investigation of CYP enzyme- and transporter-mediated drug interactions to:
- Determine whether the investigational drug alters the pharmacokinetics of other drugs
- Determine whether other drugs alter the pharmacokinetics of the investigational drug
- Determine the magnitude of changes in pharmacokinetic parameters
- Determine the clinical significance of the observed or expected drug interactions
- Inform the appropriate management and prevention strategies for clinically significant drug interactions
Course Level - Basic
Who Should Attend
- Clinical Research Associates
- Medicinal Chemists
- Project Managers
- Business Development Managers
- Medical Writers
Why Should You Attend
Many drugs undergo metabolism to be eliminated from the body. Drugs can be metabolized in several organs; however, drug metabolism primarily occurs in the liver and intestine. These organs express a wide variety of drug-metabolizing enzymes and are responsible for the biotransformation of many drugs. Hepatic metabolism occurs primarily through the CYP family of enzymes located in the hepatic endoplasmic reticulum. The potential for interactions between these metabolizing enzymes and investigational drugs, by initiating in vitro metabolic studies before first-in-human studies to inform the need for and design of clinical PK studies, is a regulatory requirement. In order to obtain market authorization, drug makers need to assess the potential for a new drug to generate clinically relevant drug interactions. It is therefore important for all involved in this field to have a basic understanding of drug interactions and of how this is investigated during drug development.