Robert Moore, recent graduate of a top MBA program, now realizes what it's like to be on the other side of a case study. It is December 2006 and Hyperion, the young biotechnology start-up of which he has just become project manager, is faced with critical manufacturing choices. Moore and Jeff Hurst, the company's CEO, had met to discuss the situation, and in the following weeks Hurst was expected to present the company's manufacturing strategy to the board of directors. In the meantime, he asked Moore to evaluate Hyperion's options in detail and give his own recommendation. Hyperion's first potential product, "Cellular Regulatory Protein 1" (CRP-1), had been the subject of extensive experimentation and analysis in the company's R&D laboratories for several years. several years. The next major hurdle was human clinical trials, which typically took place over several years. However, before Hyperion could launch clinical trials, it had to decide how and where CRP-1 would be manufactured. To ensure the safety of participants, the United States Food and Drug Administration (FDA) has imposed strict guidelines; products tested on humans had to be manufactured in facilities certified for “clinical grade” production. Since CRP-1 was the company's first product to enter the clinic, Hyperion did not have a manufacturing facility that met FDA requirements. options for supplying CRP-1 to the clinic: The first was to build a new 5,000 square foot pilot plant with sufficient capacity to supply all of the CRP-1 needed for Phases I and II of the clinical trials. The second option was to outsource clinical trials. manufacturing to an external company. And a third option was to license manufacturing to another biotech company or pharmaceutical company. Under this third option, the licensee would be responsible for all manufacturing, clinical development and eventual commercialization of CRP-1. Specific risks and rewards were attached to each option, and Moore knew that the one ultimately chosen by Hurst would have long-term consequences for Hyperion's survival in an extremely competitive and high-stakes pharmaceutical industry. Background: Hyperion was founded in 2001 by Dr. Alan Ball, an internationally renowned researcher at Children's Hospital and associate professor of clinical medicine at Greaves Medical Center, to develop pharmaceuticals based on a class of proteins called protein factors. cellular regulation. From 2002 to 2005, Dr. Ball and a small group of scientists who joined Hyperion studied ways to produce CRP-1 outside the human body. Although CRP-1 is a naturally occurring protein found in human blood plasma, the amount that could be extracted was far too small for commercial use...