Psychiatry - August 2008 - (Page 58)

[research to practice] passionate champion for his or her own drugs. There were some heated debates among the multidisciplinary team members. For example, in the mid-1990s, Seroquel (quetiapine) was competing with Accolate (a leukotriene antagonist drug to treat asthma) as well as with some infectious disease, cardiovascular, and oncology drugs during its development. played a large role in our planning process and decision making. HOW DID YOUR MARKETING RESEARCH AFFECT DRUG DEVELOPMENT DECISIONS AND PLANNING? Mr. Milbauer: An important part of marketing research meant that we went to the physicians who actually treated the patients. We could not have proceeded without learning from these clinicians. In fact, sometimes we realized that our so-called “breakthrough” treatments might change the way physicians practiced. Although exciting in some respects, changing beliefs and practices is challenging and was an operational issue for our planning group. HOW WERE DECISIONS MADE ABOUT WHICH DRUG SHOULD BE DEVELOPED? Mr. Milbauer: We were a company dedicated to finding breakthrough drugs, but we could not afford to put all of our eggs in that basket. So, we needed to A pivotal step for the planning team’s ultimate decision to support Seroquel was the effective partnering with the CNS discovery team so that we and senior management could be educated about the drug’s real potential. consider many factors beyond the breakthrough potential when we chose a drug for further clinical development. We began by educating ourselves about the disease and the putative drug. We invited clinical experts and practicing physicians to teach and inform us about the disease, the existing treatments, the existing competition, and the market need. We examined the challenges to successful product launch, including the specifics of the drug (preclinical toxicities, formulation, manufacturing issues, dosing, clinical trial issues), the likely duration of exclusivity of our drug versus the competition, our sales resources in that therapeutic area, as well as the potential profitability of the drug in the marketplace. Market research 58 Psychiatry 2008 [ A U G U S T ] One example is the drug Zoladex (goserelin) a one- or three-month injectable depot used to treat prostate cancer. This injectable LH/RH analogue suppresses testosterone and might obviate the need for surgery in some cases. Initially, we thought our market would be the oncologists but quickly realized that our real targeted physician group was urologists. Well, urologists are surgeons and we were introducing a treatment that was an alternative to surgery! Although we believed we had a treatment that was good for patients, we had to convince the urologists to store an injectable drug, get reimbursement from third-party insurers, including the Federal government, and forego surgery. We identified key opinion leaders to work with our drug and ultimately we changed some of their perceptions and practices. Another example is the anesthetic drug Diprivan (propofol), which really changed the way anesthesiologists practice medicine. Prior to our drug, surgical anesthesia involved shortacting pentothal followed by gases, like halothane, for most surgical procedures; patients were often nauseated and drowsy postoperatively. However, our product was an injectable that seemed “foreign” to most anesthesiologists, although it provided easy induction, kept the patient safely under anesthesia for 3 to 4 hours, and avoided nausea postoperatively. Our drug was expensive relative to inhalational gases. The key to a successful launch meant convincing hospital pharmacies to budget for and store our drug (previously gases were kept in the operating room) and getting physicians to try it. We succeeded and created the market for our drug. Today, it is used for more than 50 percent of surgeries. HOW DID YOUR PLANNING GROUP VIEW SEROQUEL DURING ITS DEVELOPMENT? Mr. Milbauer: Actually, Seroquel was a challenging product for development support. We had no previous experience with schizophrenia, let alone CNS, and had no sales force to meet with psychiatrists. We had some preclinical concerns about cataracts in beagles and dosing questions, and we knew that we would be the fourth or fifth entry into the US market. A challenging product might be supported for further development if there was existing expertise inside the company, including a sales force, and we believed we could support working through the challenges.

Table of Contents Feed for the Digital Edition of Psychiatry - August 2008

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

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.