Executive Summary:
Case talks about the Nucleon Inc’s manufacturing and business strategy for different clinical trials phases and ultimately short-term and long-term business strategy. Nucleon is a small biotechnology company who focus on developing Cell Regulating Protein-1 (CRP-1) pharmaceutical product. Company started with research scientists and their entire focus was on research and development. Nucleon finished the pre-clinical trial with positive results and they are ready to perform clinical trial on human. Nucleon also has very good advantage over technology and has very good linkage to the universities and research group.
Till this point Nucleon’s focus was entirely on R&D with no consideration CRP-1 manufacturing process at the large scale. Now as Nucleon ready to perform clinical trial on human, nucleon has to consider different manufacturing options and finalize it before it is too late. Nucleon has three manufacturing process option for phase I and II: 1) Build an in-house pilot plant. 2) Contract production to a third-party. 3) License the development and manufacturing right to corporate partner for initial fee and royalty on sale. By considering advantages, disadvantages and SWOT analysis of different manufacturing options, Nucleon has to choose the right decision to sustain in short run and to last in long term business in highly competitive pharmaceutical industry.
Key points, opportunities and recommendation: * Key issue of the case is to identify the right manufacturing option for clinical trial Phase I and Phase II. Nucleon has three manufacturing process: 1) Build an in-house pilot plant 2) Contract production to a third-party 3) License the development and manufacturing right to corporate partner
Now let’s look at each of option for its pros and cons. | Build an in-house pilot plant | Contract production to a