2C or Not 2C: CYP2C Induction Studies for Successful Preclinical Risk Assessment
This webinar was presented by: Becky Campbell, Principal Scientist in Program Oversight, and Andrew G. Taylor, Ph.D., Technical Support Manager for Services
As a part of IND-enabling preclinical drug development studies companies are required to meet regulatory expectations to evaluate the induction potential of their compound for the cytochrome P450 CYP enzymes CYP1A2, 2B6, 2C8, 2C19 and 3A4. While only CYP1A2, 2B6 and 3A4 must be assessed in the initial induction panel, any observed induction of CYP3A4 requires further investigation of induction potential for enzymes in the CYP2C family due to shared activation by the PXR nuclear receptor pathway. This webinar will focus on CYP2C induction and will emphasize when to include CYP2C induction in a study, how to design the study to generate meaningful data and meet the regulatory requirements, what endpoints to measure, and how to interpret results.
Keypoints covered in this webinar include:
- Enzyme Induction studies in DDI risk prediction
- Crosstalk and other mechanistic considerations
- Conditions that warrant 2C investigation
- Regulatory expectations for induction data
- Standard CYP2C induction assay design
- Positive controls
- Appropriate test systems
- Endpoints (mRNA versus activity)
- Efficient planning to anticipate CYP2C inclusion
- Possibility of metabolites masking induction when looking at activity as an endpoint
- How to interpret results
About the Presenters
Becky Campbell, B.S. Principal Scientist in Program Oversight
Rebecca Campbell joined SEKISUI XenoTech in 2001. Prior to joining SEKISUI XenoTech, she obtained her Bachelor of Science in Biology from the University of Central Missouri and studied toxicology and pharmaceutical sciences at the University of Missouri-Kansas City School of Pharmacy. Rebecca has extensive experience in in vitro CYP induction studies, regulatory compliance, and project management. As a Principal Scientist in Scientific Operations, she is responsible for the conduct and oversight of the nonclinical, drug interaction-related contract studies in the Program Oversight Department of SEKISUI XenoTech’s Scientific Division.
Andrew G. Taylor, Ph.D. Manager, Technical Support for Services
Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego, Scripps Institution of Oceanography. He joined SEKISUI XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies compliance with Good Laboratory in Practices (GLP), OECD Principles of GLP, &/or Japan MOHW GLP Standards and specializing in drug transport and drug metabolism studies. He became the Technical Support Manager for services in 2020 and provides valuable guidance to ensure research needs are being met.