This is the first column of a series discussing how advances in pharmacogenomic information (PGI) and molecular biology are leading to changes in the product labels of existing drugs and providing new targets for drug discovery. This column first introduces the concept of PGI and defines related terminology. The authors then discuss how new information on genetic variations in patient responses to drugs has led to revisions in the product labels of many already marketed drugs. Rapidly expanding PGI has also led to the development of new drugs with novel mechanisms of action. Such drug development has been especially common in oncology, with new agents being developed to target genetically specific forms of cancer. The authors review how genetically determined variations in the pharmacokinetics and pharmacodynamics of a drug in a specific patient can make that patient “sensitive” or “resistant” to the effects of that particular drug. This type of PGI is expanding the concept of “special populations” to include patients with genetically determined differences in pharmacokinetics and/or pharmacodynamics. The second column in this series will explain how increased knowledge of molecular pharmacology and PGI has resulted in the revision of product labels for drugs already on the market, using pimozide as an example. The third column in this series will deal with the discovery of new drugs with novel mechanisms of action, with a focus on oncology drugs. The last column in the series will discuss the need to make this knowledge readily accessible to clinicians at the time and point of therapeutic care. (Journal of Psychiatric Practice 2013;19:142–149)
SHELDON H. PRESKORN, MD, is Professor, Department of Psychiatry, University of Kansas School of Medicine-Wichita, and Chief Science Officer and Medical Director, Kansas University- Wichita Clinical Trials Unit (KU-W CTU), Wichita, Kansas. He has more than 35 years of drug development research experience at all levels (i.e., preclinical through Phase IV) and has been a principal investigator on over 350 clinical trials—funded by industry, the federal government, or private foundations—including trials of every antidepressant and antipsychotic medication marketed in the United States over a period of 25 years. Dr. Preskorn maintains a website at www.preskorn.com where readers can access previous columns and other publications. CASSANDRA R. HATT, a master’s student at the University of Texas at Dallas in the School of Behavioral & Brain Sciences, is currently studying cognitive neuroscience and normal aging under the direction of Denise Park, PhD., at the Center for Vital Longevity in Dallas, TX.
Disclosure statement: Over his career, Dr. Preskorn has worked with over 100 pharmaceutical companies in the United States and throughout the world. Over the past year, Dr. Preskorn has received grants/research support from or has served as a consultant, on the advisory board, or on the speakers bureau for the following: Abbott, AssureRx Health, Bristol-Myers Squibb, Cyberonics, Envivo, Johnson & Johnson, Merck, National Institute of Mental Health, Naurex, Novartis, Pfizer, Stanley Medical Research Institute, Sunovion, and Taisho.