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 outsourcing production or even licensing. The obvious appeal of licensing would be an immediate cash payment and future royalties avoiding any large capital investment in manufacturing, enabling the company to concentrate solely on R&D. Licensing at this early stage would inevitably generate much lower revenues, but in addition to that, the industry specific circumstances in producing and scaling up complex processes in genetically engineered drugs there would be another consideration against being solely an R&D laboratory. Cloning a molecule in an R&D environment is a long way from getting it actually processed and manufactured in a plant for commercial use. Another alternative to building the small pilot plant would be outsourcing manufacturing for Phases I&II eliminating the high capital investment required for building the pilot plant since there is always a risk CRP-1 would not pass clinical trials, meaning the pilot plant could not be used for many years before they could get another product to clinical trials. This risk might be outweighed by the fact that it would be nearly impossible to contract the manufacturer without prior disclosure of confidential information such as proprietary product details. To...
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