Minimize risk when preparing for hepatic impairment studies

Dr Nolan Wood joined Certara in 2017 as a consultant in the clinical pharmacology and translational medicine group, providing clinical pharmacology leadership and stewardship to develop high quality, innovative clinical pharmacology programs supporting global drug development. Dr. Wood has more than 35 years of global drug development experience working in the pharmaceutical industry and as a consultant, covering all stages of development, from first-in-human studies through to regulatory submissions, including pediatric drug development. He has worked across a wide range of therapeutic areas involving both small molecules and biological products. Working as the global clinical pharmacology lead, he has taken responsibility for implementing model-informed drug development strategies resulting in successful global regulatory approvals for several compounds. He has contributed to the design and execution of studies in special populations including patients with renal and hepatic impairment and pediatric populations. Dr. Wood has extensive experience of interactions with the major health authorities and has written Clinical Pharmacology sections for regulatory submissions and requests for information.

Following a degree in Pharmacology, Dr Wood obtained a PhD in the Clinical Pharmacology Group at the University of Southampton. He has (co-) authored over 40 peer-reviewed publications and is a member of the British Pharmacological Society.

Dr. Barter has over 20 years of experience in drug metabolism, transport, complex interactions, and specific populations with a strong background in in vitro to in vivo extrapolation (IVIVE). She received her PhD in Drug Metabolism from the University of Sheffield in 2005. This was followed by a joint position as a Postdoctoral Researcher within the Unit of Clinical Pharmacology at the University of Sheffield and Research Scientist at Certara. In 2009, she joined Certara full-time where she has been involved in projects related to extrapolating clearance and extending compound and population databases within Simcyp Simulator and modeling of complex transporter and metabolism mediated drug-drug interactions and inter-ethnic differences in pharmacokinetics.