Clinical Trial and Nucleon Assignment Notes

Category: Addiction, Manufacturing

Last Updated: 06 Jul 2020

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Nucleon Assignment Notes Porter’s 5 Forces Industry Analysis •Competition: Intense •Buyer Power: Moderate to High oBig pharma companies likely have a lot of power, although as a small firm, your power increases once you clear phases of drug trials. •Supplier Power: Unsure, Moderate? oThe case makes it sound like there’s not many manufacturers out there for contracting purposes. Not sure what power suppliers of raw materials have. •Threat of Substitutes: Moderate to High oLots of firms racing to create the next blockbuster drug or treatment for big money illnesses.

However, most drugs fail, so the likelihood of a substitute is probably only moderate. •Threat of New Entrants: Moderate oRelatively easy to start a new small drug research firm. Just need some smart scientists. Funding is currently difficult to come by, however. Nucleon •Competition: Moderate to Low oThe case mentioned they were in a pretty niche area of biotech. •Buyer Power: Moderate to High oBig pharma companies likely have a lot of power. But if Nucleon clears phase II their power increases substantially. •Supplier Power: Unsure, Moderate? The case makes it sound like there’s not many manufacturers out there for contracting purposes. Not sure what power suppliers of raw materials have. •Threat of Substitutes: Moderate to Low oI don’t think there’s much out there in the way of burn treatments (need to check on that). •Threat of New Entrants: Moderate to Low oThe drug research process is slow, so any new entrant in this specific area is going to be significantly behind with little to no way to catch up. Resource Based View VRIO Value:There’s definitely value in a successful drug for burn treatment; it also presents itself as a possible cure for other ailments as well (i. . kidney failure) Rarity:Not many alternatives for burn victim treatment (assumption based on the case’s voice); large molecule research is still new and rare, tough to get into. Imitability: Not very imitable, especially if Nucleon can gain strong patent protection. Also, the slow development time means that even if another firm could mimic a similar drug, it would take time. Organization:Nucleon is currently not organized to begin trials and manufacturing of this drug. They also don’t have a significant amount of financial backing at this point.

Transaction Based Economics Hold-ups •Contract manufacturer could hold up Nucleon for more money if drug passes phases and becomes more likely to be successful. •Contract manufacturer could increase manufacturing costs, slow production, or create problems in quality in order to hold up Nucleon. Options Going Forward Option 1: Build Pilot Plant Pros •Nucleon keeps tighter control of IP •Can retain ownership of product rights through phase I and II •More flexibility •Can begin to develop staff for in-house manufacturing, making scaling later easier Cons Expensive (likely need more financial backing/don’t have enough as is) •Risky oDrug could fail in clinical trials (which statistically is likely) oProcess uncertainty; bacterial vs. mammalian cells •Distracts Nucleon’s financial and human capital away from their core, the drug R&D Option 2: Contract Manufacturing Pros •No major upfront capital investment •Access to experienced manufacturing facilities and staff immediately •Retain ownership of product rights through phase I and II Cons •Still not cheap; doesn’t save Nucleon much money over Option 1 •Risk of IP issues Contract specifics are very difficult to hash out due to the nature of biotech •No faster than building their own plant due to slow process of negotiating, knowledge transfer, then scale-up Option 3: Licensing Pros •No capital investment •Little to no risk •Simple; allows Nucleon to focus on the R&D •Immediate cash flow •Keep rights for CRP-1 for other uses (other than for burn treatment) Cons •Much less share in the profits if drug is successful (mortgage the company’s success) •Would likely lower employee morale, which could in turn decrease likelihood of success of drug •Risk of IP issues

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