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 An Introduction to Drug-Drug Interactions: Can in vitro DDI data replace expensive clinical studies? 

The study of pharmacokinetically mediated drug-drug interactions (DDIs) is an essential part of the discovery and development of new drugs. In this webinar, we will introduce the key principles applied to study and predict the impact of DDIs, along with an insight into regulatory guidances that apply.

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  • Introduction
    • Overview and key thoughts
  • Overview of current regulatory guidances
    • Focus on guidances covering drug-drug interactions (DDIs) from FDA, EMA, PMDA & China
  •  Studying Drug-Drug Interactions In Vitro 
    • Introduction of methods to study inhibition, induction and recognition by drug metabolizing enzymes and transport proteins
  • In Vitro & In Vivo Extrapolation of DDIs
    • Static scaling of in vitro data
    • Case Examples

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Moderated by: Katherine Fenner - Director ADME/DMPK​ at Pharmaron 


Prof Amin Rostami-Hodjegan, PharmD, Ph.D., FCP, FAAPS, FJSSX - Director, CAPKR at University of Manchester

The scientific work of Professor Rostami covers wide areas of drug development over last 30 years, ranging from pharmaceutics (e.g. bioequivalence) to clinical pharmacology (e.g. mixture pharmacology of drug/metabolites) and beyond (e.g. provision of systems parameters for human tissue for in vitro to in vivo (IVIVE) scaling).

As a leader in the field of physiologically-based pharmacokinetics (PBPK) and quantitative systems pharmacology (QSP), Amin is internationally recognized for his expertise in the use of IVIVE to predict the behaviour of drugs in human body and understanding the associated inter-individual variabilities under the so called “bottom up” modelling.  Amin is a Professor of Systems Pharmacology and the Director of CAPKR (Centre for Applied Pharmacokinetic Research) at the University of Manchester. In addition, he is the Senior Vice President of Research & Development and Chief Scientific Officer at Certara. He facilitates the incorporation of the latest advances in translational modelling to biosimulation platforms offered by Certara to its pharmaceutical clients to accelerate regulatory approvals and bring safer drug products to the patients faster.

More than 300 highly cited articles have been authored by Amin (>19,000 citations, H-Factor = 75).

In 2017 the Institute of Scientific Information (ISI, Clativate) listed him as one of the world’s most highly cited researchers (under ‘Pharmacology & Toxicology’). He is also at 0.06% top rank of the Highly Cited Researchers List by Elsevier for pharmacology (2020). He was a founding editor of Pharmacometrics and System Pharmacology, and serves on the Editorial Boards of several other journals.

Michael Hall, Ph.D. - Manager, in vitro & DDI at Pharmaron

After completing his PhD studies at the Department of Biochemistry, University College London in 1984, Michael moved to the Institute of Cancer Research in London as a postdoctoral research fellow.  There he investigated the stereochemistry of the metabolic activation of polycyclic aromatic hydrocarbons.  Through it, he gained familiarity with the area of xenobiotic metabolising enzymes and drug metabolism generally.  In 1988 Michael moved to Huntingdon Research Centre (now a part of Labcorp), where he specialised in in vitro techniques applied to DMPK studies.  He became the inaugural Head of the Department of In Vitro Metabolism in 1998, and Head of In Vitro Metabolism and Biotransformation in 2012.  Michael left Huntingdon in 2013 and joined Quotient Bioresearch Ltd. (now Pharmaron UK), firstly as Business Development Manager for the company’s In Vitro Services and, in November 2014 as Head of the In Vitro and DDI Services group.

Michael has published over 20 peer-reviewed scientific papers and numerous other articles and book chapters and has presented many posters and oral communications at international conferences.  He is a reviewer for the journal Xenobiotica.  While at Huntingdon, Michael served on the committee of the Drug Metabolism Discussion Group and was Chairman during 2011, its 40th Anniversary year.

Jia Jia, PhD - Associate Director, ADMET at Pharmaron

Dr. Jia joined Pharmaron in 2018 and is the associate director of the in vitro ADME department in Ningbo. She is leading an experienced team that supports sponsors for early screening ADME assays. She manages the progress of projects, provides scientific input to optimize assay systems and ensures high quality data submission in a time efficient way. Dr. Jia received her M.S. degree in cell and molecular biology from the University of Hannover, Germany in 2007 and her Ph.D degree in the area of drug transporters from the clinical pharmacology institute at the University of Greifwald, Germany in 2013. Her research was focused on transporter studies using in vitro and in vivo models. Jia then worked for 4.5 years at a biotech company in Germany primarily working on metabolic stability and DDI assays using liver microsomes and hepatocytes.

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