ICH M12 Draft Guidance on Drug Interaction Studies

Date: June 30 2022
Presenter(s): Noémi Szili, PhD

Presenter(s): Noémi Szili, PhD, Scientific Marketing Manager, SOLVO Biotechnology

Summary of the presentation:

In June 2022, the ICH released their M12 harmonized draft guideline on Drug Interaction Studies. The ICH, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, aims to harmonize guidelines released by multiple regulatory agencies for the same purpose in order to create a single reference document that can be applied across borders. The ICH M12 will ultimately become the standard guidance for Sponsors developing compounds from pre-clinical through final submission for registration. The guideline covers both in vitro and clinical drug metabolizing enzyme- and transporter-mediated drug-drug interactions by providing recommendations to support investigations and data interpretation. In this webinar, we are going to walk through the main elements of a DDI investigation study with a focus on changes in this new guidance compared to those previously published by FDA, EMA, and PMDA, and other regulatory documents. The regulatory list of drug metabolizing enzymes and transporters will be discussed, including considerations for selecting assay systems and conditions, and data interpretation guidelines. As currently the ICH M12 is a draft guidance released for public feedback and commentary, we also aim to address some of the recommendations based on our experience as a CRO experience and share our initial thoughts. The presentation will be followed by a Q&A session and panel discussion with multiple senior SOLVO colleagues on board to address our first impressions of the new guidelines and discuss future perspectives.

About the presenter:

Noémi Szili, PHD

Scientific Marketing Manager, SOLVO Biotechnology


Noémi Szili obtained her master’s degree in genetics and Cell biology at Université Paris Diderot in 2013. She obtained her PhD in microbiology from Bio Sorbonne Paris Cité specialized in Microbiology in 2017. During her time in Paris, she was involved in multiple research projects at the Pasteur Institute, including the study of bacterial ABC transporters. She started her professional career at SOLVO – a Charles River company in 2018 in a Scientific Business Development role and was promoted to Scientific Marketing Manager in 2021. She is responsible for most scientific marketing collateral in support of SOLVO’s portfolio. Serving as scientific liaison, she also works closely with the local commercial team, R&D group and management, and is a member of Charles River’s Discovery Advocates scientific advisory group. Noémi has published multiple research articles, is a co-author in the latest SOLVO Transporter book, and regularly hosts webinars and trainings