Introduction

Why should you follow DDI guidance even if you don’t have to?

In January, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. While current regulatory documents on the subject of preclinical drug interaction data provide recommendations for industry rather than requirements, the drug interaction experts at SEKISUI XenoTech have built a solid reputation on understanding exactly what the regulatory agencies will accept when it comes to approving a drug for clinical phases.

In this presentation, Dr. Ogilvie will offer his expert perspectives on major updates in the FDA’s Final Guidance for Industry and take a magnifying glass to the differences between expectations of EMA, FDA, and PMDA for a successful Clinical Trial Application (CTA) or Investigational New Drug (IND) application. Whether you are looking to submit to one agency or multiple, this presentation will lay a foundation for what you need to know about designing preclinical drug interaction studies to satisfy current expectations and anticipate follow-up or clinical DDI studies.

The webinar will commence at 08:00 CT (USA) / 14:00 GMT (UK) / 15:00 CET (Europe)

Following the presentation, Dr. Ogilvie will be joined by Principal Scientist Lois Haupt to answer audience questions.

Key concepts discussed in this webinar will include:

  • An overview of the major changes between Draft and Final FDA guidance for industry

  • Regulatory recommendations vs requirements

  • How current guidance from FDA, EMA, and PMDA relate

  • A comparison of each agency’s guidance documents

  • Highlighted differences between equations and cutoff values

  • A comparison of experimental details

  • How to design studies to meet the expectations of each agency’s guidance documents

  • Special attention to success with EMA

  • Impacts on in vitro DDI study design and interpretation

  • How SEKISUI XenoTech approaches developing effective strategies to ensure drug development programs are not delayed

  • Why good science is always a trump card

About the Presenters:

Brian Ogilvie - Vice President, Scientific Consulting
Dr. Brian Ogilvie obtained his Ph.D. in toxicology from the University of Kansas Medical Center and B.A. in molecular biology from William Jewell College. He joined XenoTech in 1997. From 1999 to 2006 Dr. Ogilvie was the head of the CYP Inhibition Department at SEKISUI XenoTech. Brian is an author or coauthor on over 50 scientific posters, peer-reviewed publications and book chapters on the topics of drug metabolism, transport and drug-drug interactions, and has represented the company as an invited speaker at various drug metabolism conferences. In April 2006, Brian became a member of the SEKISUI XenoTech Consulting Department, in which he participates in drug-drug interaction-related R&D projects and authoring various publications, and also writes expert opinions for consulting clients. As Vice President of Scientific Consulting, Dr. Ogilvie is additionally involved in quality management and strategic planning for the company in scientifically relevant areas.
Lois Haupt – Principal Scientist, Program Oversight
Lois celebrates her 20th year with SEKISUI XenoTech this summer, beginning as a Scientist I in the Enzyme Inhibition service group and working her way up to Principal Scientist in Program Oversight. Her expertise spans drug metabolism research and regulatory compliance, and her specific area of expertise encompasses CYP and UGT inhibition assays along with data interpretation and follow-up to these studies. Lois obtained her Bachelor of Science in Chemistry from Creighton University in 1995, and gained experience working as a chemist prior to joining SEKISUI XenoTech. She has been first or contributing author on multiple peer-reviewed publications and abstracts and has extensive training as a Study Director as well as areas including GLP standards, technical writing, liquid chromatography, and biostatistics.