2017

Comparison Between the US FDA, EU EMA and Japan PMDA In Vitro DDI Guidance Documents: Are We Close to Harmonization?

Aired:  19 December 2017

Co-Presenters: Brian Ogilvie, Ph.D., Sekisui XenoTech Vice President of Scientific Consulting, and Andrew Parkinson, Ph.D., XPD Consulting Chief Executive Officer
 
In September, the Japan PMDA revised its 2014 guideline and released it (only in Japanese) for comments. In October, the US FDA revised and split its 2012 draft guidance for industry on in vitro drug-drug interaction (DDI) studies, into one document for in vitro DDI studies, and another for clinical DDI studies. Drs. Andrew Parkinson, XPD Consulting, and Brian Ogilvie, Sekisui XenoTech, will offer their expert perspectives on major changes and differences between the two agencies’ in vitro guidance documents, and how to harmonize your drug development strategies to meet the expectations of both.

Key concepts discussed in this webinar will include:
  • An overview of the major changes and comparison of each agency’s guidance documents
  • A comparison of the equations and cutoff values
  • A comparison of experimental details
  • How to design studies to meet the expectations of each agency’s guidance documents

Register here to request access to the slides and recording of the webinar as well as the English-translated PMDA guideline document. Our convenient and informative reference poster is also available for download.

Essential Considerations on the New FDA In Vitro DDI Guidance (the What, the Why, and the Wow)

Aired:  21 November 2017

Presenter: Brian Ogilvie, Ph.D., Sekisui XenoTech Vice President of Scientific Consulting
 
In October, the FDA revised and split its 2012 draft guidance for industry on in vitro drug-drug interaction (DDI) studies, into one document for in vitro DDI studies, and another for clinical DDI studies. Dr. Brian Ogilvie will offer expert perspective on major changes to the in vitro guidance, whether they will impact your drug development strategy, and with more than two decades of experience in the area what Sekisui XenoTech’s strategy is to address potential development challenges presented by the draft.

Key concepts discussed in this webinar will include:
  • An overview of the major changes
  • Are these recommendations or requirements?
  • Views of the worldwide DDI guidance landscape
  • Impacts on in vitro DDI study design and interpretation
  • How Sekisui XenoTech approaches developing effective strategies to ensure drug development programs are not delayed
  • Considerations of whether to wait until the draft guidance is final, or to progress development of new drug candidates
  • Why good science is always a trump card

Request links to the slides and recording here:

Drug Metabolizing Enzymes and Transporters in NASH

Aired:  15 February 2017

Research Application of Variants of Fatty Liver Disease (FLD) Tissues

Presented by Maciej Czerwinski, Ph.D., Sekisui XenoTech Director of Consulting

Sekisui XenoTech is committed to the support of research into human diseases, particularly of the liver. In the course of over twenty years of pharmacokinetic studies in human hepatocytes, we have accumulated normal and diseased tissues representing FLD with or without history of excessive alcohol consumption and steatohepatitis. In this webinar, characteristics of the FLD and the effects of the condition on drug metabolism and disposition will be outlined. Organ collection procedures, storage and characterization of the specimens, as well as features of donors with and without significant consumption of alcohol, T2 and T1DM and pediatric donors will be described.

Key concepts discussed:
  • Fatty liver disease – characterization and progression
  • Effects of fatty liver diseases on drug metabolism and transport

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