《《Nucleon inc》.pdfVIP

For the exclusive use of G. REGENSBURGER Harvard Business School 9-692-041 Rev. April 14, 1994 Nucleon, Inc. Robert Moore, a recent graduate of a top-ranked M.B.A. program, now realized what it was like to be on the other side of a case study. It was December 1990 and Nucleon, the young biotechnology start-up at which he had recently become project manager, faced critical manufacturing choices. Moore and Jeff Hurst, the firm’s CEO, had met to discuss the situation, and within the next few weeks, Hurst needed to present the company’s manufacturing strategy to the board of directors. In the meantime, he asked Moore to evaluate in detail Nucleon’s options and give his own recommendation. Nucleon’s first potential product, “cell regulating protein-1” (CRP-1), had been undergoing extensive experimentation and analysis in the company’s RD laboratories for several years. The next major hurdle was human clinical trials, which also typically took place over several years. However, before Nucleon could launch clinical trials, it had to decide how and where CRP-1 would be manufactured. To ensure participants’ safety, the U.S. Food and Drug Administration (FDA) imposed strict guidelines; products being tested in humans had to be made in facilities certified for “clinical grade” production.1 Since CRP-1 was the company’s first product to go into the clinic, Nucleon had no manufacturing facilities which met FDA requirements. It was face