Thursday, May 23, 2019

Clinical Trial and Nucleon Assignment Notes

Nucleon Assignment nones Porters 5 Forces Industry Analysis Competition Intense Buyer military unit discuss to high up oBig pharma companies promising experience a lot of occasion, although as a small firm, your power increases once you clear stages of drug trials. supplier superpower Unsure, deem? oThe miscue makes it go away like theres not many manufacturers out there for contracting purposes. Not sure what power suppliers of tippy materials have. terror of Substitutes Moderate to High oLots of firms racing to create the next blockbuster drug or treatment for big property illnesses.However, most drugs fail, so the likeliness of a substitute is likely only moderate. Threat of New Entrants Moderate oRelatively easy to start a new small drug research firm. sound need some lustrous scientists. Funding is currently difficult to come by, however. Nucleon Competition Moderate to Low oThe case mentioned they were in a pretty quoin 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 switch off 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 particularized 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 drug for fly off the handle 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 mollify new and rare, tough to find o ut into. Imitability Not very imitable, especially if Nucleon can gain strong patent protection. Also, the slow development time means that notwithstanding if another firm could mime 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 substance of pecuniary 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. extracts 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 than flexibility Can begin to develop ply for in-house manufacturing, making scaling later easier Cons Expensive (likely need more financial back ing/dont have enough as is) endangermenty oDrug could fail in clinical trials (which statistically is likely) oProcess uncertainty bacterial vs. mammalian cells Distracts Nucleons financial and human capital of the United States away from their core, the drug R&D Option 2 Contract Manufacturing Pros No major upfront capital investment funds 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 delinquent to the nature of biotech No straightaway 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 make out in the profits i f 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 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 moderate. Threat of New Entrants Moderate oRelatively easy to start a new small drug research firm. Just need some smart scientists. Funding is currentl y 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 drug for burn treatment it also presents itself as a possible cure for other ailments as well (i. . kidney failure) RarityNot many alternatives for b urn 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 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-hous e 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 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) Co ns 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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