Dermatological Drug Development
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).
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.
“There is no book like this. I have been an investigator and advisor for many dermatological drug developments, but the process of the drug development is far more complex than expected, and it is difficult to understand unless you are in the pharmaceutical industry and experience direct interactions with regulatory authorities. The book is different from a usual textbook as the authors are very skilled and experienced in the pharmaceutical industry, [and reveal] the complex process of dermatological drug development toward the approval. This book is useful for many people involved in dermatological drug development and clinical trials. You will enjoy reading what activities are happening when new treatment becomes available on the market. Dermatological treatments are different from treatments with other targets. Assessing the skin for efficacy and side effects in various dermatological conditions are all integrated in this unique book. [It] is a must-have when you consider dermatological drug development.”
Professor Peter van de Kerkhof
Head, Department of Dermatology, Radboud University Nijmegen Medical Centre, the Netherlands
“Drs. Maeda-Chubachi, Hussey, and Furst have produced a very concise and ambitious book. Dermatological Drug Development is the first to outline and explain the process with its many unique features. Encompassing the authors’ widely varying perspectives and extensive experience in the field, it also beautifully captures the difficulties in satisfying the many requirements for regulatory approval, as well as the rationale for them. The authors’ perspective is that of the pharmaceutical industry, and the book will undoubtedly be of great value to those just entering this specialized field, including those transferring from other drug development areas. The text also highlights the added challenges for therapies intended for a global market and makes a convincing plea for internationally harmonized guidelines specific to dermatologic drug development and approval. The extensive bibliography points the interested reader to primary regulatory documents and the relevant medical literature. The book leaves me, as a clinician, in awe of the drug development process and deeply grateful to the professionals in industry and government who undertake it. I was particularly drawn to the sections describing special considerations in drug development for pediatric skin disease and the instructive “case histories” for recent and on-going drug development programs in psoriasis, atopic dermatitis, vitiligo, and several other diseases. The importance to all stakeholders of this book and of optimizing dermatological drug development is summarized in the book’s last and bolded sentence: Patients are waiting.”
Professor Barbara Gilchrest
Department of Dermatology, Massachusetts General Hospital
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