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Radioalabelled Human Studies: Challenges of Clinical Metabolite Analysis
This webinar will show the importance of clinical metabolite analysis and the analytical methodologies used to address the regulatory requirements.
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Agenda
- How Can We Increase Confidence in Prediction of Human Circulating Metabolites?
- General overview of current industry thoughts and practices
- Analytical Techniques and Study Designs for Clinical Metabolite Profiling
- Example of integrated study involving radiolabelled human ADME, including AMS to identify major clinical metabolites
- Clinical Metabolite Identification
- How do we conduct metabolite analysis and identify metabolite structures from carbon-14 chemical metabolism studies?
Moderated by: Barry Jones, Ph.D. – Chief Scientist, Global DMPK at Pharmaron
Speakers
Emre M. Isin, Ph.D. – Head of Drug Metabolism and Pharmacokinetics at Servier
Dr. Emre M. Isin received his Ph.D. in chemistry under Prof. Neal Castagnoli’s supervision at Virginia Tech and did his postdoctoral work with Professor F. Peter Guengerich at Vanderbilt University Medical School. Dr. Isin has worked at various roles at the DMPK department at AstraZeneca, Mölndal, Sweden for 10 years. He then joined UCB Biopharma in Belgium heading the global Biotransformation and Enzymology team. Currently, he is leading the DMPK department at Servier. His scientific research interests are drug metabolism and xenobiotic metabolizing enzymes, in particular cytochrome P450s, as well as metabolism mediated toxicity and drug design. Over the years, he has published 35 articles in these areas in various peer-reviewed journals.
Marie Croft, Ph.D. - Scientific Director, Radiolabelled Sciences at Pharmaron
Marie Croft is Scientific Director, Radiolabelled Sciences at Pharmaron. She has over 17 years of experience in bioanalytical applications of accelerator mass spectrometry (AMS). Following her graduation from De Montfort University in 2004, Marie started her career with Xceleron Ltd, obtaining hands on laboratory experience in AMS and LC+AMS analysis. During this time, she conducted research into AMS microdosing, specifically cassette dosing in DDI studies, and combined use of AMS and PET after microdose administration. She received her PhD in ‘Applications of human microdosing with accelerator mass spectrometry’ from the University of York in 2013. Marie works primarily with the 14C-bioanalysis team based at Pharmaron ABS, Germantown, and plays a key role in the design, review and execution of hADME studies.
Eleanor Barton, MChem - Team Leader, Programme Management at Pharmaron
Eleanor has more than 20 years’ experience working in the pharmaceutical CRO industry, with the last 10 years specializing in human radiolabeled mass balance studies. She graduated from the University of York, UK in 2000 with a Master of Chemistry, during her degree she also spent a year in Germany at the University of Münster, working on her Master’s thesis. Eleanor began her career at BioDynamics (now Pharmaron UK), working in the bioanalysis group for 10 years, developing an in-depth knowledge of liquid-chromatography, tandem mass spectrometry (LC-MS/MS) and sample extraction technique. In 2013, she moved into the Pharmaron UK Metabolism department where she has since set up and developed the Programme Management team. This function is instrumental in aiding clients running complex drug development programmes across the Radiolabelled Sciences activities within Pharmaron. Furthermore, Eleanor’s team are responsible for managing all clinical metabolite profiling and identification studies performed at Pharmaron UK, working closely with clients to ensure the metabolite identification objectives of a human mass balance study are met.
David Neville, BSc – Team Leader, Metabolite Identification at Pharmaron
David has more than 28 years’ experience working in the pharmaceutical CRO industry, with the last 7 years working in the metabolite identification group at Pharmaron. He graduated with a degree in Chemistry from the University of Hertfordshire in 1995 and started to work in regulated bioanalysis using GC-MS. In 2001, David moved to the Horse Racing Forensic Lab, Fordham (now Drug Development Solutions) and made the switch to LC-MS. At Fordham, David established a small molecule discovery team using in vitro techniques to study drug metabolism and eventually became Principal Scientist overseeing the development of all bioanalytical methods, from extraction to chromatography. In 2015, David moved to Pharmaron, joining the highly-experienced metabolite identification team, using accurate mass LC-MS to solve some of the most interesting scientific challenges for our clients.
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