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SYMPOSIUM: PROGRESS IN PHARMACOGENETICS AND ITS PROMISE FOR MEDICINE

Implications of Pharmacogenomics for Drug Development

Third Security, LLC, Radford, Virginia 24141

To whom requests for reprints should be addressed at ¹ Third Security, LLC, 1881 Grove Avenue, Radford, VA 24141. E-mail: randal.krk{at}gmail.com

Abstract

The use of pharmacogenomics (PGx) today is almost ubiquitous in drug development and is advancing into the practice of medicine as an increasing number of drugs come to market with indications that are related to the presence or absence of a specific genetic biomarker. The authors review the history of PGx and its tools in research, in clinical trials and in clinical medicine. The economic, regulatory, and technological driving forces for adoption of PGx are then considered. Current impediments to a more robust proliferation of the benefits of these technologies are discussed—pharmaceutical companies, clinical education, required statistical methods, and intellectual property landscape.

Key Words: pharmacogenomics • drug development • clinical trials • metabolizers • biomarkers