Robert Moore, a recent graduate of a top-ranked MBA program, now realized what it was like to be on the other side of a case study. It was December 2006 and Hyperion, 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 Hyperion's options and give his own recommendation.
Hyperion's first potential product, "cell regulating protein-1" (CRP-1), had been undergoing extensive experimentation and analysis in the company's R&D laboratories for several years. The next major hurdle was human clinical trials, which also 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 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.
Since CRP-1 was the company's first product to go into the clinic, Hyperion had no manufacturing facilities which met FDA requirements. It was faced with three options for supplying CRP-1 to the clinic: The first was to build a new 5000 square-foot pilot plant with enough capacity to supply all the CRP-1 needed for Phases I and II of clinical trials. The second option was to contract clinical manufacturing to an outside firm. And a third option was to license the manufacturing to another biotechnology company or to a pharmaceutical firm. Under this third option, the licensee would be responsible for all manufacturing, clinical development, and eventual marketing of CRP-1. Definite 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 the intensively competitive and high-stakes drug industry.
Background: Hyperion was founded in 2001 by Dr. Alan Ball, an internationally respected researcher at the Children's Hospital and an Associate Professor of Clinical Medicine at the Greaves Medical Center, to develop pharmaceutical products based on a class of proteins known as cell regulating factors. From 2002 to 2005, Dr. Ball and a small group of scientists who joined Hyperion researched ways of producing CRP-1 outside the human body. Although CRP-1 was a naturally occurring protein contained in human blood plasma, the amount that could be extracted was far too small to be of any commercial use.
Nucleon is a small biotechnology start-up with a very promising potential product (CRP-1), which is also the first product that Nucleon is planning to go into the clinic market. Nucleon has reached to human clinical trials phase with its product and it has no manufacturing facilities that satisfy the guidelines for these clinical trials and testing. Nucleon is on the verge of making a critical choice of manufacturing strategy, which will affect Nucleon’s survival in the intense competition in the long haul. Nucleon management is aware of the facts that they have a limited budget to start with, the financial environment in biotechnology is rapidly changing and establishing the safety and efficacy of products like CRP-1 is complex, time-consuming and expensive; that’s why they want to evaluate risks and rewards of each manufacturing strategy before making their final decision.
FDA, so many people were harmed. Even other countries versions of the FDA approved it which
2. What steps did Jack Moore (the CIO for Heartland Healthcare System) bypass with his oversight of the IT project? Jack Moore's action in advancing Heartland's IT department was very careless and lacked cautions. Jack negligence and Richard Smith (CEO) failure to get involved has genuinely put Heartland Healthcare system in a potential financial dilemma. Let begin with all the step that Jack chose to ignore. Healthcare IT is rapidly advancing, and no one person is capable of mastering all the area of Information technology. Jack failures to engage others is what causes heartland to experience such financial losses and put the organization tech department behind the eight ball. Jack also has decided not to involve current staff member of Heartland
Many people believe that in order to succeed in a business that is having difficulties, it is important to focus on a particular area in order to be better productive in each of them, and be able to reach the goal. Instead, Goldratt and Jonah demonstrates that is important to focus on the company as a whole, but at the same time, it shows that it is incorrectly to only focus in an specific manufacturing department, or one plant, or a department within the plant, because people should not be concerned in local optimums.
that can be used by scientists to design and optimize new designed drug. Using the exact same
Testing on animals cannot accurately predict what will work in humans. Medical breakthroughs have, in fact, happened without the use of animal testing. For every 5,000 tests used in labs, only a handful are ever deemed to be safe enough to be used in humans. Of the few that
Over the past decade, scientists have made significant advancements in the treatment of certain diseases. Unfortunately, just like any new product, the cost of developing these new technologies and treatments is extremely high. Plus, unlike other technology, heath technolo...
For a drug to get to market it must go through several stages of research and development (Abbott and Vernon). Starting with discovery research, preclinical testing on animals, three phases of clinical trials on humans, and finally FDA (Food and Drug Administration) approval (Abbott and Vernon). Out of several thousands of drugs only a few will make it to the FDA approval stage (Abbott and Vernon). Testing is a highly regulated, time consuming, and expensive process. From beginning to end the process can take fifteen years and less than one of five compounds will make it to market where it is still not guaranteed to succeed (Abbott and
Episode 143: Fredrick Winslow Taylor’s Scientific Management 2013, YouTube, Alanis Business Academy, 19 Nov, retrieved April 4 2014,
trials of investigation medical products. The FDA also has to review and approve in a
The case under analysis, Eli Lilly & Company, will be covering the positives and negatives with regards to the business situation and strategy of Eli Lilly. One of the major pharmaceutical and health care companies in its industry, Lilly focused its efforts on the areas of "drug research, development, and marketed to the following areas: neuroscience, endocrinology, oncology, cardiovascular disease, and women's health." Having made a strong comeback in the 1990's due to its remarkably successful antidepressant Prozac, was now facing a potential loss in profits with its patent soon to expire. The problem was not only the soon to expire patent on Prozac, but the fact that Prozac accounted for as much as 30% of total revenue was the reality Eli Lilly now faced. (Pearce & Robinson, 34-1)
Manufacturing businesses and business leaders need to increase their focus on key success factors such as: innovation, productivity improvement, investment in people & skills, and funding. Innovation is not just about retention and development, or the latest technology. It’s also about practical and efficient problem solving and business transformation. In the manufacturing industry, this can be achieved by: refining or exploring new supply and distribution channels, establishing new business offerings, developing leaner organizational arrangements, improving processes, providing a better customer experience, and accessing green, clean technology – high on the agenda for environmentally conscious customers (Performance, 2011)
Miles and Snow’s typology is centered on four types of businesses; each with its own strategy. These business types are those of prospectors, defenders, analyzers, and reactors. A prospector tends to be a firm which often introduces new products to the market (p.196). These businesses can be described as risk takers, typically being some of the first firms to introduce a new product to the market. Prospectors are flexible and meet industry changes head-on by rising to challenges and creating new and improved
Many cures and treatments for illnesses have been created by animal testing for decades. According to the California Biomedical Research Association, many scientific breakthroughs have been recorded by the contribution of animal testing (“Should Animals Be Used for Scientific or Commercial Testing?”). For
...nuing to profit from the substaining usage of animals in scientific laboratories, the tradtional method is difficult to dispose of. The method is kept for the currency but fails to produce major reliable success as those of the alternative methods. A statisict shown in Safer Medicines Trust states, "that nindy-two percent of drugs fail in clinical trials, having successfully passed through animal studies." These corportaions care more about the amount of money profited than the reliablitily of the results from animal testing.