Nucleon is a small biotechnology start-up company focused on developing biotechnological pharmaceutical products based on a class of proteins known as cell regulating factors. The company has been in the market for five years, and currently, they are in the process of human trials for their first potential product, “cell regulating protein-1” (CRP-1). Overcoming these phases, Nucleon has to decide among several alternatives on producing CRP-1. Knowing that the process involved a tremendous amount of time and money, Nucleon has to choose the right decision for their long-term survival in the intensively competitive and high-stakes drug industry.
Before a drug is launched to the market, it has to pass human trials to get approval from the FDA. There are three phases on human trials: (I) basic safety assessment, where the drug was administered to healthy volunteers to find out any adverse reactions. This phase would require 6-12 months and if there is no serious side effect, the product then (II) administered to patients having disease the drug was presumed to treat to find out whether the patients’ condition improved or suffered by any adverse side effects. This phase would require 1-2 years and then, (III) the product’s efficacy is assessed with a relatively large sample of patients on statically rigorous basis that involved multiple hospitals and required 2-5 years. It would take around 8 years to complete these trials and would cost around 30-100 million. While the drug is promising, Nucleon could not get enough funding for their growth (current capital $6.5 million) and having only 22 workers available within the company would not help either. At this stage of its development, it is crucial to compare and see the risks and advantages of each manufacturing alternative.
There are three options available for phase I and II. Table 1 lists each of their advantages and disadvantages. PHASE I & II...
Please join StudyMode to read the full document