What’s New in Clinical Drug-drug Interaction Studies: Recommendations from Regulatory Authorities and Scientific Consortia

Pharmacokinetic drug-drug interaction studies are in a state of transition—and there is often confusion around requirements and timing. They have transformed from studies of empirically-selected narrow therapeutic window and concomitantly-prescribed medications to systematic and mechanistic evaluations of a compound’s potential for interaction with key drug-metabolizing enzymes and transporters. This paradigm shift offers improved safety for participants in clinical trials and for patients after drug approval. An attractive incentive of these efforts for the industry is the development of robust in vitro systems and modelling approaches that eliminate the need for clinical drug-drug interaction studies in many cases.

Implementing these advances has been a daunting task for industry, academics and regulatory authorities. Regulators recognize the need for flexibility to accommodate an ever-expanding knowledge base in a timely manner. The US Food and Drug Administration (FDA) has released several draft guidances that reflected their current thinking on best practices for in vitro and clinical evaluations with the latest documents released in October 2017. Other regulatory authorities from around the world are actively focused on this issue and new regulatory guidance from the European Medicines Agency (EMA) is expected at any time.

This webinar will focus on recent scientific and regulatory developments on the design of clinical drug-drug interaction studies. Talking points will range from general concepts targeted towards scientists in drug development to specific recommendations from recent publications aimed at researchers directly involved in the design of clinical drug-drug interaction studies.

Key points to be discussed include:

• Timing of drug-drug interaction studies
• Which enzymes and transporters should be evaluated
• The potential role of cocktail and microdosing drug-drug interaction studies
• Selection of probe drugs and duration of dosing

Speaker

Carol Collins, MD, Senior Clinical Pharmacologist, Medpace

Dr. Carol Collins has over 20 years of experience in drug-drug interactions including serving as associate medical director of a Phase I unit. She was a senior research scientist/clinical associate professor in the department of pharmaceutics at the University of Washington where she collaborated on the development of the Metabolism and Transport Drug Interaction Database and as co-investigator on clinical studies.

She received her MD from Ohio State University and is certified in regulatory affairs (RAC) and as a principal investigator (ACRP). She has co-authored numerous publications and presented at national and international conferences on this topic. She is currently a member of the American Society of Clinical Pharmacology and Therapeutics, the American Society for Pharmacology and Experimental Therapeutics, the American College of Clinical Pharmacology, the Association of Clinical Research Professionals and the American Association of Pharmaceutical Scientists.

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