Dermatological Drug Development

Tomoko Maeda-Chubachi · Elizabeth Kernodle Hussey · Sylvia Furst

Sep 2020 · Cambridge Scholars Publishing

About this ebook

This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).

About the author

Tomoko Maeda-Chubachi, MD, PhD, MBA, is Vice President at Novan, where she provides medical input to drive the strategy, design, and execution of its programs. She served as an academic physician and a board-certified dermatologist for 10 years before entering the pharmaceutical industry. She received her MD and PhD from Osaka University, Japan, and has authored a number of journal articles on clinical trial results.

Elizabeth Kernodle Hussey, PharmD, is Vice President of Clinical Pharmacology and Pharmacokinetics at Nuventra, Inc., and has 30 years’ experience in the pharmaceutical industry. She received her PharmD from the University of North Carolina-Chapel Hill. She has worked on numerous clinical trials and drugs, and has authored more than 40 journal articles.

Sylvia Furst, PhD, is a Senior Toxicology Consultant with Integrated Nonclinical Development Solutions, Inc. She has also served as study director/monitor, laboratory supervisor, head of general toxicology, project team representative, and therapeutic area leader over a period of 20 years in the pharmaceutical industry. She received her PhD from the University of Toronto and her postdoctorate from the University of Arizona.