Ask the Experts: the draft ICH M10 guidance
In this Ask the Experts feature, we ask experts from across pharma and CROs to share their thoughts and perspectives on the draft ICH M10 guidance. Our panel of experts will provide insights as to what the draft ICH M10 guidance is, what it aims to achieve and its implications for bioanalytical laboratories around the world.
Questions
- Firstly, can you give a brief overview of the ICH M10, its history and where it is at currently?
- Why is there a need now for the ICH M10 guidance and for harmonization efforts?
- What have been some significant hurdles in developing the ICH M10 guidance?
- How might the ICH M10 affect individual regulatory bodies? What is the process for individual regulatory bodies to implement ICH M10?
- How does the ICH M10 affect bioanalytical outsourcing?
- What do bioanalytical labs of the future look like with the ICH M10 guidance implemented in light of recent changes in the way drugs are being developed?
Meet the experts
Mark Arnold, PhD
Director, Scientific Affairs
Labcorp Drug Development (NJ, USA)
Mark Arnold collaboratively develops and delivers innovative scientific and regulatory strategy to meet current and future client needs – including ligand-binding, cell-based, qPCR and LC-MS/MS assays to quantify drugs and metabolites, antidrug antibodies and biomarkers to support PK/PD assessments. Previously, Mark was Executive Director of the Bioanalytical Sciences Department at Bristol-Myers Squibb (NJ, USA). and responsible for both immunochemistry and LC–MS capabilities, including outsourcing to partner CROs. For 35 years, Mark has been involved in the field of bioanalysis, including the review and interpretation of regulations and guidance. He was co-chair of both the AAPS Crystal City V and VI Workshops, served as the 2018 PharSci360 Bioanalytics Track Chair, is Vice Chair for the 2020 PharmSci 360 Conference and is an AAPS Fellow. He received a BSc in biology from Indiana University of Pennsylvania (PA, USA), a PhD in pharmacology from the University of Pittsburgh (PA, USA) and has over 100 peer-reviewed publications and podium presentations.
Rob Nelson, PhD
Associate Director, Scientific Affairs
Labcorp Drug Development (Geneva Switzerland)
Robert Nelson is an Associate Director with Labcorp’s Science and Innovation team, focused on partnering with clients and internal staff to solve bioanalytical technology, scientific and regulatory issues, from discovery through post-market approval. Previously, Rob served as Section Head, Bioanalytical Sciences, Exploratory Science & Translational Medicine at Novimmune (Geneva, Switzerland) where he was responsible for delivery of product-specific bioanalytical endpoints for nonclinical and clinical studies, including pharmacokinetic, pharmacodynamics, biomarker and immunogenicity endpoints. Building on over 15 years of biological and analytical research experience, Rob is a Steering Committee member for the European Bioanalysis Forum, a Lecturer at the University of Geneva (Geneva, Switzerland), and has authored or co-authored numerous peer-reviewed publications, abstracts and posters. Rob received his BSc in Pharmacology and his PhD in Molecular Physiology from the University of Edinburgh (UK).
Kelly Dong, PhD
Chief Executive Officer
United-Power Pharma Tech Co., Ltd., (Beijing, China)
Kelly obtained her PhD from McGill University (Montreal, Canada). She has more than 26 years of multinational industry experience working for GSK, Shire and CROs in Canada, the UK and China. Her scientific expertise encompasses drug discovery DMPK and regulated bioanalysis for preclinical and clinical development. Kelly joined United-Power Pharma as Chief Executive Officer in February 2018. Kelly is one of the key founders and steering committee members of the China Bioanalysis Forum (CBF). She is also a deputy director of the China Pharmaceutical Bioanalysis Association.
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