Minimize risk when preparing for hepatic impairment studies

Dr. Osborn has over 25 years of drug development experience in the areas of clinical pharmacology and pharmacokinetics. She has focused on oncology and anti-infectives. Before joining Certara, she was a reviewer in the Office of Clinical Pharmacology, US Food and Drug Administration, in the Division of Cancer Pharmacology, CDER, where she participated in the assessment of multiple dose justification submissions under Project Optimus. Prior to working in the FDA, she was a clinical pharmacologist in the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institute of Health (NIH). There, projects were focused on therapeutics and vaccines in the infectious disease area. She worked on design and support of phase 1 trials, bioanalytical assay development and validation, and projects using the “Animal Rule” to support development of countermeasures in situations where clinical trials were not ethical or feasible. Dr. Osborn has held roles supporting both clinical and nonclinical pharmacology drug development for large molecules in biotechnology companies including Human Genome Sciences and CoGenesys. She is particularly interested in early phase drug development, including dose selection and justification strategies to speed development of therapeutics.
Dr. Osborn holds a PhD in Pharmacology from The George Washington University.

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.