Google Winning
Project Paper
Summary
Nucleon Inc. was founded in 1985 by Dr. Alan Ball. From 1985 until 1988 Dr. Ball and a small group of scientists researched ways of producing CRP-1 outside the body. CRP-1 is a cell regulating protein which Nucleon Inc. believed would be effective at treating burn wounds and acute kidney failure. In the field of biotechnology there was intense competition in R&D and patent protection. Nucleon believed it had a strong patent position on the CRP-1 molecule; its rights to other necessary proprietary positions were less certain. Nucleon’s management believed this to be a strong niche market since there was a large enough market and no available alternative treatments. Since CRP-1 was too big to synthesize, they used genetic engineering methods to produce the initial quantities. They first isolated small amounts of natural CRP-1, determined the gene produced CRP-1, and proceeded to clone it for testing. The first step Nucleon took was the 6-8 months of animal testing. By this point Nucleon would have spent 6 to 10 million in R&D and document preparation. To get FDA approval, Nucleon would have to undergo three phases of testing by the end of which they could have expected to pay $30-100 million dollars. Subject to the constraints of their limited capital availability, Nucleon was forced to choose between various options moving forward with CRP-1.
5 Options for all 3 Trial Phases
The New Pilot Plant
The Pilot Plant would be a 5,000 square foot facility with state-of-the-art processing equipment. This plant would meet all of the FDA’s standards for producing CRP-1 for Phase 1 and 2 of the clinical trials. Unfortunately, this plant would not be large enough to for Phase 3. Nucleon currently did not have the financial resources to produce a facility large enough to make the CRP-1 for Phase 3 trials. Nucleon would have full ownership of their product if work was done in the pilot plant.
Pros:
* The pilot plant would give Nucleon a clear
Summary
Nucleon Inc. was founded in 1985 by Dr. Alan Ball. From 1985 until 1988 Dr. Ball and a small group of scientists researched ways of producing CRP-1 outside the body. CRP-1 is a cell regulating protein which Nucleon Inc. believed would be effective at treating burn wounds and acute kidney failure. In the field of biotechnology there was intense competition in R&D and patent protection. Nucleon believed it had a strong patent position on the CRP-1 molecule; its rights to other necessary proprietary positions were less certain. Nucleon’s management believed this to be a strong niche market since there was a large enough market and no available alternative treatments. Since CRP-1 was too big to synthesize, they used genetic engineering methods to produce the initial quantities. They first isolated small amounts of natural CRP-1, determined the gene produced CRP-1, and proceeded to clone it for testing. The first step Nucleon took was the 6-8 months of animal testing. By this point Nucleon would have spent 6 to 10 million in R&D and document preparation. To get FDA approval, Nucleon would have to undergo three phases of testing by the end of which they could have expected to pay $30-100 million dollars. Subject to the constraints of their limited capital availability, Nucleon was forced to choose between various options moving forward with CRP-1.
5 Options for all 3 Trial Phases
The New Pilot Plant
The Pilot Plant would be a 5,000 square foot facility with state-of-the-art processing equipment. This plant would meet all of the FDA’s standards for producing CRP-1 for Phase 1 and 2 of the clinical trials. Unfortunately, this plant would not be large enough to for Phase 3. Nucleon currently did not have the financial resources to produce a facility large enough to make the CRP-1 for Phase 3 trials. Nucleon would have full ownership of their product if work was done in the pilot plant.
Pros:
* The pilot plant would give Nucleon a clear