Development plan Essay

The assignment is to design a development plan and prepare a summary presentation for outlicensing. This will involve deciding which therapeutic indication is most appropriate for this compound, evaluate its competitive viability, estimate its commercial potential, prepare a target product profile, provide a marketing perspective of the intended consumer, design a clinical development plan with milestones and decision points and suggest potential remedies to liabilities

Presentation should include about- CT-189 Sigma1 Inhibitor for the Treatment of Castration-Resistant Prostate Cancer:

Do not give an overall description about prostate cancer. Just discuss the topics provided. Please dont be vague as well

  1. Competition

Can we actually talk about specific competitor drugs – use these –

  1. https://ascopubs.org/doi/10.1200/JCO.19.01638
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042720/
  3. Sales Forecast-I don’t think we can confidently say that “during our research, we have come to realize…” You can say that based on preclinical mice models, and the drug’s MOA, we anticipate that CT-189 blah blah. All of the Phase I/II/III stuff are mock trial designs with NO real data. We don’t know what will actually happen.
  4. Differentiation
  5. Market Size

c.Top competitors

  1. orphan drug status about CT-189
  2. Pricing vs combination therapies- What are the actual prices of the combination therapies? (1. Each Pill price, 2. Each product total Profit to date, and 3. Total Estimated Market Value of $ spent on Prostate Cancer drugs in general each year in the US?)
  3. CT-189 Commercial Viability- “Lack of available treatments” is not true. There are a number of treatment available for CRPC. the problem is, their overall survival is still not great. Patients are still dying between 9-36 months. We need more treatment to help extend their lives. I wouuld like you to mention of the unique MOA – that is true and the main reason why CT-189 will be efficacious and profitable.

you can mention Merck pharma because they are testing Pembro in mCRPC.

PRESENT THE DETAILS IN SUCH A WAY WHERE THE DRUG HAS NOT BEEN THROUGH CLINICAL TRIALS YET. PRESENT IT AS WE ARE TRYING TO PURSUE CLIN