2019

In Vitro Induction Studies: Elements of Design and Important Considerations in Data Analysis

Aired:  24 April 2019

Presenter: Joanna Barbara, Ph.D., Vice President of Scientific Operations at Sekisui XenoTech

Synopsis:
When evaluating drug-drug interaction (DDI) risk of an investigational drug, a battery of studies is needed to investigate victim/perpetrator potential. One of these comprises evaluation of the potential of a new therapy to induce drug-metabolizing enzymes, which can impact clearance of concomitantly administered drugs. The team at Sekisui XenoTech has built a reputation of dedicating high quality resources and specialists to conduct such studies with scientific rigor.

In this webinar, Dr. Joanna Barbara will address frequently asked questions from sponsors seeking induction studies and elaborate on some recommendations we give to achieve successful regulatory submission. Points of discussions will include an overview of enzyme induction studies and critical considerations in design, from determination of supporting data to conclusive interpretation.

Key concepts discussed in this webinar will include:
  • Standard study considerations
  • FDA guidance requirements
  • Required endpoints for IND submission
  • 3A induction and associated challenges
  • Next-step recommendations


Register to attend on Wednesday, April 24th at:
9am EDT / 3pm CEST
2pm EDT / 8pm CEST
or to watch on-demand after the event

In Vitro Evaluation of Immunomodulating Drugs as Perpetrators of Drug Interactions

Aired:  20 February 2019

Presenter: Dr. Maciej Czerwinski, Sekisui XenoTech Director of Consulting

Synopsis:
On October 15th, 2018, Sekisui XenoTech presented on "In Vitro Direct and Cytokine-Mediated Effects of Therapeutic Peptides and other Biologics on CYP Enzymes" at the Peptide ADME Discussion Group Workshop in Gothenburg, Sweden. Following subsequent requests for a follow-up webinar, Dr. Czerwinski will be presenting on the following subjects...

Key concepts discussed in this webinar will include:
  • Immunomodulators
  • Mechanisms of immunomodulator drug-drug interactions (DDI)
  • Regulatory guidance on evaluating DDI potential of biologics
  • Study design to evaluate direct and cytokine-mediated effects of immunomodulators on drug metabolizing enzymes
  • Case studies of experiments conducted according to our study design...