2022 ISSX/MDO Meeting
We’re looking forward to the ISSX/MDO Meeting in Seattle on Sept. 11-14, including the corresponding Hepatocyte Research Association Meeting at 6:30pm on Sept. 12th! We’re proud to be a sponsor of both events and will be presenting on recent regulatory updates in ADME & Drug-Drug Interaction (DDI) evaluation strategies at 12:15pm on Sept. 12th.
Talk Abstract:
In June 2022, the ICH released the first draft of its global harmonized Drug Interaction Studies Guideline (M12) and FDA released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”
Join us to hear a brief overview of these updates and the relevant in vitro drug metabolism and drug-drug interaction studies and test systems along with recommendations for your drug development strategy.
Learning Objectives:
- An overview of recent ADME/DDI regulatory updates
- Relevant types of in vitro ADME & DDI studies
- When to conduct these studies
- Areas of concern: Proper design & interpretation
Anyone aiming for a successful IND / NDA submission, needing to meet regulatory requests and expectations, desiring to formulate a development plan that mitigates risks of late stage delays or failure, or simply wanting to better understand the ADME properties and potential DDI risks of their compound will benefit from attending this talk.
Contact a member of our team to schedule a meeting or submit questions.