Psychiatry - August 2008 - (Page 57)

Research to Practice WHAT WAS YOUR ROLE IN THE DRUG DEVELOPMENT PROCESS? Mr. Milbauer: During my years at AstraZeneca, I had several roles related to commercial drug development: At one point, I was Vice President of Planning and was responsible for leading a group of product planners and market researchers who served on several multidisciplinary teams, which comprised key scientists and physicians and were used to determine the right development course for any new product. At another time, I was Vice President for Drug Regulatory Affairs and was primarily responsible for interactions with the FDA.4 WHO WAS ON THE MULTIDISCIPLINARY TEAMS? Mr. Milbauer: The multidisciplinary teams included drug discovery scientists, clinicians, drug safety specialists, marketing and planning specialists, as well as experts in legal and regulatory affairs. Our company had six distinct therapeutic area subgroups that met separately prior to meeting with our group. These subgroups varied from oncology to infectious disease to cardiovascular to central nervous system (CNS), and each subgroup had their own products to promote for further funding. We might have been evaluating and planning for 15 different drugs at any point in time. The Process of Getting New Drugs to Market by Steven D. Targum, MD, and Alan J. Milbauer, RPh, JD Psychiatry (Edgemont) 2008;5(8):57–60 INTRODUCTION The introduction of a new psychotropic medication to the US commercial market follows a complex process that may extend many years from the initial discovery of the putative drug through the US Food and Drug Administration (FDA) approval and final market launch. At the prescriber end of this process, clinicians may not be fully aware of the deliberate steps required by pharmaceutical companies to gain FDA approval or aware of the internal company discussions that ensue about how best to introduce a new drug to the market. In this column, I interviewed Alan J. Milbauer, a retired vice president from AstraZeneca, who agreed to discuss the challenges of drug development from the perspective of a pharmaceutical company executive. WAS THERE INTERNAL COMPETITION BETWEEN NEW DRUGS FOR PSYCHIATRY VERSUS ONCOLOGY OR OTHER THERAPEUTIC AREAS? Mr. Milbauer: Absolutely. We could not fund every promising new product through the entire development cycle. The chair of each subgroup needed to be a [AUGUST] Psychiatry 2008 57

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Psychiatry - August 2008 Editor’s Message Editorial Advisory Board Contents Borderline Personality Disorder: Are Proliferative Symptoms Characteristic? Short-acting versus Long-acting Medications for the Treatment of ADHD Baby Stimuli and the Parent Brain: Functional Neuroimaging of the Neural Substrates of Parent-Infant Attachment These Boots Are Made for Stalking: Characteristics of Female Stalkers Managing Attention Deficit Hyperactivity Disorder in the Emergency Department Obstructive Sleep Apnea, Hypoxia, and Metabolic Syndrome in Psychiatric and Nonpsychiatric Settings Improving the Quality of Life in Patients with Alzheimer’s Disease The Process of Getting New Drugs to Market Journal Watch Classified Advertising Information for Authors

Psychiatry - August 2008

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