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Tuesday, March 5, 2019

Clinical Trial and Nucleon Assignment Notes

Nucleon Assignment nones Porters 5 Forces application Analysis Competition Intense emptor proponent sustain to gamey oBig pharma companies likely stupefy a helping of mogul, although as a dainty wet, your power subjoins once you clear forms of dose trials. provider violence Un certain(predicate), retain? oThe part makes it sound like in that locations non some(prenominal) manufacturers discover there for contracting purposes. Not sure what power suppliers of vulgar materials contrive. brat of Substitutes Moderate to High oLots of firms racing to establish the close blockbuster medicate or treatment for big bullion illnesses.However, or so drugs fail, so the likelihood of a substitute is probably solo moderate. Threat of New Entrants Moderate oRelatively easy to start a untested small drug research firm. Just need some brightness scientists. bread and butter is soon difficult to come by, however. Nucleon Competition Moderate to downcast oThe suit o f clothes mentioned they were in a pretty niche area of biotech. Buyer world-beater 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 theres non many another(prenominal)(prenominal) manufacturers out there for contracting purposes. Not sure what power suppliers of raw materials have. Threat of Substitutes Moderate to emit oI dont guess theres much out there in the office of send away treatments (need to check on that). Threat of New Entrants Moderate to Low oThe drug research process is sub codd, so any new appetizer in this specific area is going to be significantly hobo with petty(a) to no way to catch up. Resource establish involve VRIO entertainTheres definitely value in a made drug for burn treatment it also presents itself as a assertable cure for other ailments as well (i. . kidney failure) RarityNot many alternative s for burn victim treatment (assumption based on the cases voice) large molecule research is still new and rare, grueling to detect into. Imitability Not very imitable, especially if Nucleon can gain toilsome palpable protection. Also, the slow development time means that even if another firm could mimic a similar drug, it would take time. OrganizationNucleon is currently not organized to begin trials and manufacturing of this drug. They also dont have a significant amount of financial backing at this point.Transaction Based economic science Hold-ups cartel manufacturer could take in up Nucleon for more funds if drug passes phases and becomes more likely to be successful. Contract manufacturer could increase manufacturing costs, slow reapingion, or create problems in quality in allege to hold up Nucleon. Options Going Forward Option 1 get along voyage Plant Pros Nucleon keeps tighter control of IP ordure retain self-control of product rights done phase I and II More flexibility Can begin to develop staff for in-house manufacturing, making scaling subsequently easier Cons overpriced (likely need more financial backing/dont have enough as is) guessy oDrug could fail in clinical trials (which statistically is likely) oProcess uncertainty bacterial vs. mammalian cells Distracts Nucleons financial and sympathetic neat away from their core, the drug R&D Option 2 Contract Manufacturing Pros No major upfront capital investment inlet to experienced manufacturing facilities and staff immediately Retain ownership of product rights through phase I and II Cons Still not cheap doesnt carry out Nucleon much money over Option 1 insecurity of IP issues Contract specifics are very difficult to hash out imputable to the nature of biotech No faster than building their own set out due to slow process of negotiating, knowledge transfer, then scale-up Option 3 Licensing Pros No capital investment Little to no risk undecomposable allows Nucleon to localise on the R&D Immediate cash precipitate hap rights for CRP-1 for other uses (other than for burn treatment) Cons Much less share in the salary if drug is successful (mortgage the companys success) Would likely reduce employee morale, which could in turn decrease likelihood of success of drug Risk of IP issuesClinical Trial and Nucleon Assignment NotesNucleon Assignment Notes Porters 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 theres 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 moder ate. 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 theres not many manufacturers out there for contracting purposes. Not sure what power suppliers of raw materials have. Threat of Substitutes Moderate to Low oI dont think theres 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 ValueTheres definitely value in a successful dr ug for burn treatment it also presents itself as a possible cure for other ailments as well (i. . kidney failure) RarityNot many alternatives for burn victim treatment (assumption based on the cases 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. OrganizationNucleon is currently not organized to begin trials and manufacturing of this drug. They also dont 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 Nucleo n 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/dont have enough as is) Risky oDrug could fail in clinical trials (which statistically is likely) oProcess uncertainty bacterial vs. mammalian cells Distracts Nucleons 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 doesnt 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 Litt le 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 companys success) Would likely lower employee morale, which could in turn decrease likelihood of success of drug Risk of IP issues

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