• Myriad and OncorMed and the Marketing of the First Genetic Tests for Breast Cancer Susceptibility

    Two companies, Myriad Genetics and OncorMed, competed to develop a genetic test for breast and ovarian cancer susceptibility. Although the two companies had offered genetic testing only to women who participated in their research studies, in 1995, both were considering selling their testing services to physicians generally. Despite the promising market for this testing service, some scientists and patient activist groups believed that it was premature to provide testing outside a carefully controlled research environment, where data could be collected on an ongoing basis to answer significant questions about the health consequences of genetic mutations and the potential benefits and risks of testing. Specifically, they argued that commercialization should wait because knowledge about an inherited predisposition to breast cancer was still emerging, and medical care options for mutation carriers were limited and not proven to be of benefit. In addition, data on the psychological and social effects on women who were tested were still evolving. Those in favor of restricting such testing to the research setting wanted laws in place to protect individuals from irresponsible testing practices, loss of privacy, and genetic discrimination. Details the decisions that Myriad and OncorMed made regarding their testing services and how the two companies addressed the concerns of those outside the company.
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  • Genzyme and the Research Ethics Questions Associated with Its NeuroCell-PD (TM) Trials

    Genzyme Tissue Repair (GTR) had just received favorable Phase I clinical trial results, an important first step in gaining approval from the Food and Drug Administration (FDA) for its NeuroCell-PD. The groundbreaking technology behind NeuroCell-PD (developed by Diacrin, Inc.) used fetal pig cell neural transplants to treat Parkinson's disease. GTR was eager to get NeuroCell-PD to market as quickly as possible but knew that the path to obtaining FDA approval would be difficult. Genzyme, an innovative biotechnology company, had often entered uncharted territories in the past and had set precedents in medical research. Controversy would likely center on whether GTR would use what some were calling "sham" surgery as a placebo control in its Phase II trials of NeuroCell-PD in Parkinson's patients--trials intended to demonstrate both the efficacy and safety of the procedure. In sham surgery, a segment of patients in a study undergo the same aspects of the surgery experience as those receiving the experimental treatment, except that it does not involve fetal pig cells. Details the process for testing NeuroCell-PD and discusses the issues concerning sham surgery. Asks students to make a recommendation on whether to conduct sham surgery.
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  • Zeneca's Direct-to-Consumer Advertising of Nolvadex (R)

    In May 1999, the Moon Shot team gathered to review the results of a $54.4 million direct-to-consumer (DTC) ad campaign. Moon Shot was a cross-functional team at Zeneca Inc., a pharmaceutical, agrochemical, and specialty products company. The ad campaign was to promote the use of the drug Nolvadexa (Zeneca's brand name for Tamoxifen Citrate) for use in reducing the risk of breast cancer in women at high risk, an estimated 9 million women in the United States. Details Zeneca's development of Tamoxifen and how the company marketed the drug. Focuses on Zeneca's DTC prescription drug advertising campaign and the issues that campaign raised.
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  • Developing and Marketing a Blockbuster Drug: Lessons from Eli Lilly's Experience with Prozac

    In 1987, Eli Lilly began to market Prozac, the first available drug in a new class of psychotropic drugs called selective serotonin reuptake inhibitors (SSRIs). Prozac, and other SSRIs that followed it, revolutionized the treatment of depression and changed the philosophy and practice of psychiatry. It allowed depression to be treated by nonpsychiatrist physicians, substantially increased the number of depressed patients who had access to treatment, and lowered the cost of treating depression and other mental illnesses. Prozac quickly became the biggest selling drug in the history of the pharmaceutical industry. Explores the history of Prozac and the factors that combined to make it the best-selling drug of all time. Provides a brief history of depression and the theories that led some scientists to pursue SSRIs. Covers Lilly's uncertain development of Prozac, the thoughtful marketing that went into the launch, and the company's post-launch marketing strategies as the drug became widely used. Emphasizes the management difficulties, including product lawsuits and patent expirations, generated by blockbuster drugs.
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  • Novartis-U.C. Berkeley Research Collaboration

    In November 1998, Steven Briggs was appointed CEO of the Novartis Agricultural Discovery Institute, Inc. (NADII), a new research institute created under the corporate umbrella of Novartis AG. NADII had a mandate to jump-start Novartis's basic research program in plant genomics, and Briggs was considering the latest research proposal terms offered by the University of California, Berkeley (UC Berkeley). Novartis was the finalist in an auction launched by the university in April 1998 to find a corporate partner with which it could establish a broad plant genomics research alliance. The arrangement was unprecedented and required a great deal of trust on the part of Novartis--trust that the Berkeley faculty could produce useful discoveries for the company's fledgling plant genomics initiative. On the surface it appeared that recent advances in the cost-intensive field of life sciences, combined with heated competition in the industry for leadership in biotechnology, had aligned the interests of the university and Novartis. Briggs was ready to approve the proposal. Before putting pen to paper, however, he considered the forces that had led to the historic agreement between Novartis and UC Berkeley, research findings, his firm's strategic choices, and academia's contribution to new discoveries.
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