Genzyme Tissue Repair (GTR) had just favorable Phase I clinical trial results, an important first step to receive the approval of the Food and Drug Administration (FDA) for its neuro-Cell PD. The breakthrough technology behind Cell Neuro-PD (developed by Diacrin, Inc.) fetal pig neural cell transplants to treat Parkinson’s disease. GTR was eager to get to Cell Neuro-PD on the market as soon as possible, but knew that the way to obtaining FDA approval would be difficult. Genzyme, an innovative … Read more »

Genzyme Tissue Repair (GTR) had just favorable Phase I clinical trial results, an important first step to receive the approval of the Food and Drug Administration (FDA) for its neuro-Cell PD. The breakthrough technology behind Cell Neuro-PD (developed by Diacrin, Inc.) fetal pig neural cell transplants to treat Parkinson’s disease. GTR was eager to get to Cell Neuro-PD on the market as soon as possible, but knew that the way to obtaining FDA approval would be difficult. Genzyme, an innovative biotechnology company, had often entered uncharted territory in the past and had precedents in medical research. Controversy would likely center on whether GTR would use what some called “sham” surgery as a placebo control group in phase II studies with neuro Cell PD in Parkinson’s patients – studies to both the efficacy and safety of the procedure to demonstrate. In sham operation, a segment of patients undergoing the same aspects in a study of the operation experience as the experimental treatment, except that it is not fetal pig cells. Details of the process for testing neuro-Cell PD and discusses the issues apparent surgery. The student requests a recommendation to make whether to perform sham surgery.
«Hide

from
Margaret L. Eaton,
Tara Thiagarajan,
Mark Hong
Source: Stanford Graduate School of Business
19 pages.
Release date: 01 May, 2005. Prod #: BME4-PDF-ENG
Genzyme and research ethics with its neuro-Cell-PD (TM) Trials HBR case solution associated

[related_post themes="flat"]