March 31st DDI Guidance Webinar with Access to a Panel of Drug Metabolism & DDI Experts
Why should you follow DDI guidance even if you don’t have to?
If you missed getting the answer to this question back in November 2020 because you were unable to attend, we are repeating this to enable our US based colleagues to participate, with a time that suits both them and any European colleagues that missed out last time too.
On March 31st, a live broadcast event hosted by the Drug Metabolism Discussion Group (DMDG) will feature a keynote presentation by our very own Vice President of Scientific Consulting, Dr. Brian Ogilvie, discussing regulatory guidance updates for entry to clinical trials through the EMA, FDA, and PMDA. Following the keynote, Dr. Ogilvie will be joined by Principal Scientist, Lois Haupt, for a Q&A with the audience. Afterwards, nine of our SEKISUI XenoTech subject matter experts will be available in a virtual chatroom for registrants to meet and ask questions.
Keynote Presentation: “Comparison Between the Final FDA, EMA, and PMDA In Vitro DDI Guidance Documents: Are We Finally Harmonized?”
In January 2020, 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.
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
Following the presentation, Dr. Ogilvie will be joined by Principal Scientist Lois Haupt to answer audience questions.
Meet the Scientist: Live Chat
Following the keynote presentation, join us in a virtual chatroom where you can meet subject matter experts in drug metabolism and drug-drug interaction (DDI) testing. The chatroom will show you who’s available for a chat and you can begin a conversation to ask a question or meet someone who can help you in your drug’s journey. Our experts all have many years of experience and this event gives you the opportunity to find answers relating to many aspects of your drug’s ADME/PK all in one place!
Subject matter expertise includes:
- Analytical Services – Seema Muranjan
- Drug Metabolism – Etsuko Usuki
- Drug Transporters – Andrea Wolff
- Drug-Drug Interaction (DDI) Consulting – Brian Ogilvie, Maciej Czerwinski, Pallavi Limaye
- Enzyme Inhibition – Lois Haupt
- Enzyme Induction – Becky Campbell