Genzyme and the Research Ethics Questions Associated with Its NeuroCell-PD (TM) Trials Harvard Case Solution & Analysis

Genzyme tissue repair (GR) has just received favorable results of a Phase I clinical trial is an important first step in getting approval from the Food and Drug Administration (FDA) for its NeuroCell-PD. Innovative technology behind NeuroCell-PD (designed Diacrin, Inc), use of fetal pig neural cell transplantation for the treatment of Parkinson's disease. GTR is very anxious to get NeuroCell-PD on the market as quickly as possible, but I knew that the way to get FDA approval will be difficult. Genzyme, an innovative biotechnology company, has repeatedly entered uncharted territory in the past and there were precedents in medical research. Disputes are likely to center on, GTR will use what some called "sham" surgery as a placebo control in the testing phase of NeuroCell-PD in patients with Parkinson's disease - the tests are designed to demonstrate the efficiency and safety of the procedure. In surgery deception, of the patients in the study are the same aspects of surgery experience as those who receive the experimental treatment, except that it is not associated with fetal pig cells. The details of the test NeuroCell-PD and discusses issues related to the operation of the imaginary. Asks students to make a recommendation on how to spend the fake surgery. "Hide
by Margaret L. Eaton, Tara Thiagarajan, All Hong Source: Stanford Graduate School of Business 19 pages. Publication Date: 01 May 2005. Prod. #: BME4-PDF-ENG

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