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Nucleon

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1/ What are your recommendations regarding the manufacturing of CRP-1 for Phase I and Phase II clinical trials? Nucleon is about to launch Phases I and II clinical trials for their first product CRP-1 (cell regulating protein-1) targeted at treating burns and kidney failure. Both clinical trials would be carried out on a small sample of volunteers lasting 6-12 months for Phase I and 1-2 years for Phase II and Nucleon has to decide how to proceed regarding the production of necessary CRP-1 as they do not have manufacturing facilities to supply it themselves. They could either build a small pilot plant for Phases I&II CRP-1 which requires time and capital investment of 3,2 million USD or consider two other options such as …show more content…

Once the Phases I&II are finished, raising the required capital for own manufacturing plant should not be a problem. For marketing and distribution Nucleon would do better to find a marketing partner. Licensing manufacturing and marketing rights at Phase III stage would also be an option, though only receiving 10% partner’s gross sales, so own in-house manufacturing would bring in more revenues as well as having more control over product quality. 2/ How would you justify your recommendations to would-be investors in the company? Nucleon has a strong patent for a niche area of cell regulating proteins and its therapeutic properties. It requires venture capital to bring drugs to clinics fast and before the competition gets there first. The company needs the venture capital to finance the pilot manufacturing facility for Phases I & II trials but also to establish process and manufacturing processes for scaling up production from a laboratory environment to a commercial plant. The drug would be clinically tested for treatment of burns and kidney failure, but CRP-1 has the potential for many other therapeutic uses . 3/ What is your recommendation regarding Nucleon’s long-term manufacturing strategy? What should this company look like in 10 years (e.g. an R&D boutique, an R&D boutique with pilot scale manufacturing capabilities, or an integrated manufacturing enterprise)? In-house manufacturing brings in considerably higher revenues

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