A Comparison of FDA, EMA & PMDA Regulatory Guidance for In Vitro Drug-Drug Interaction (DDI) Assessments

Life Sciences, Clinical Trials, Preclinical,
  • Thursday, September 10, 2020 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Join us for a discussion on today’s modern DDI testing requirements following the publication of the FDA 2020 Final Guidance and how it compares with EMA and PMDA.

Assessment of drug-drug interactions is an increasingly important component of drug development to help ensure safe efficacious medicines. Since 1997, the regulatory agencies FDA, EMA and PMDA have endorsed the use of in vitro metabolism studies to assess the DDI potential of new chemical entities (NCE). Over the past 10 years, however, scientific progress has been rapid, fueled by sophisticated in vitro models and in silico predictive programs.

To reflect this scientific progress, the FDA, EMA and Japan’s MHLW (PMDA) have issued updated guidance/guidelines outlining what in vitro data should be obtained, mainly focused on CYP enzymes and drug transporters, and how this should be processed with possible consequences for potential clinical assessment and product labeling. This webinar will review and compare these three regional guidelines for testing new chemical entities for their potential drug-drug interactions.

Drug-drug interaction status for a molecule can be of great importance – for example, a high drug-drug interaction status as a victim drug (high fraction metabolized, small therapeutic window) is at risk of restrictive labeling and even non-approval.

Speaker

David Wilkiinson, Principal Study Director, Metabolism, Covance

Following completion of BSc and MSc studies in Applied Chemistry and Toxicology, David completed his PhD in in vitro drug metabolism and toxicology at the University of Nottingham. David has been working within the CRO industry for the last 25 years (20 years at Covance Laboratories, Harrogate) in the field of in vitro drug metabolism. The majority of David’s work involves the design, conduct and interpretation of in vitro drug-drug interaction studies in compliance with current regulatory guidance.

Message Presenter

Who Should Attend?

This webinar will appeal to individuals with the following or related job titles:

  • Safety pharmacology professionals
  • Heads of preclinical R&D
  • Lead scientists

What You Will Learn

In this webinar, participants will:

  • Understand the basic in vitro tests (CYP and transporter models) required today for regulatory compliance in this area
  • Understand the approaches now used to generate the data required, how it is processed and the potential implications if certain DDI parameters (R values) are triggered
  • Learn at which stage of drug development these studies are now recommended – this is important as the FDA now recommend these in vitro studies should be conducted before clinical development begins and so ideally DDI assessment should now form part of the IND enabling program

Xtalks Partner

Covance

Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.

Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.

Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.

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