DMPK Webinar On ICH M12 Guidance On Drug-Drug Interactions

Webinar slide featuring Pharmaron scientists discussing ICH M12 guidance on drug-drug interactions in episode 26 of the DMPK series.

Capabilities

Recorded: 10 April 2025

This webinar will discuss changes in regulatory guidance about predicting the risk of drug-drug interactions (DDIs), as codified in ICH M12 compared with previous FDA and EMA guidance.

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Agenda:

The regulatory landscape of in vitro DDI assays
New aspects of testing requirements according to ICH M12
- Drug-metabolizing enzymes
- Drug transporters
- Impact of binding
Study designs and workflows
Clinical DDI risk prediction

Meet our Speakers

Moderated by:

Chris Bode – VP of Scientific Affairs at Pharmaron

Speakers

Helen Rollison – Principal Scientist, in vitro DMPK at Pharmaron

Helen Rollison is the principal scientist in the UK in vitro DMPK group of Pharmaron and is responsible for drug-drug interaction and development phase assays.  Previously Helen worked at AstraZeneca where she worked extensively on enzyme and transporter drug-drug interactions through development of routine and bespoke in vitro assays, data interpretation and clinical study design.  During this time she was the lead author of an IQ Pharma TALG/CPLG Transporters Working Group manuscript on In Vitro Transporter Assessments.  Additionally, she has developed and applied advanced hepatic models such as spheroids and flow systems for the integrated assessment of hepatotoxicity and ADME queries, including imaging, multi-omic and miRNA techniques in addition to traditional LCMS analyses.

Ying Wang – Senior Director, Regulatory in vitro ADME at Pharmaron

Dr. Ying Wang obtained her Doctor of Philosophy degree in Biological Sciences at University of California, Irvine. Dr. Ying Wang has years of research experience in developing new transporter test systems and in leading transporter mediated drug-drug interactions (DDI) studies for regulatory compliance. Dr. Ying Wang is currently serving as the Senior Director of Regulatory In Vitro ADME Studies at Pharmaron US Lab Services, promoting quick turnaround with reliable quality and scientific-sound work.

Lingling Zheng – Director, in vitro ADME at Pharmaron

Lingling has 12 years of hands-on and managerial experience in the in vitro ADME field, with in-depth knowledge of all in vitro assays, including physicochemical properties, drug metabolism, permeability and transport, and drug-drug interactions. Since May 2015, she has played a key role in establishing a dedicated regulatory ADME team, now consisting of approximately 100 scientists across the Beijing and Ningbo sites. This team specializes in conducting regulatory ADME studies to support IND and NDA filings for major regulatory authorities. As of 2024, her team has conducted regulatory ADME studies on over 1,200 compounds, including more than 400 full-package studies for IND submissions.