The assignment is to design a development plan and prepare a summary presentation for out licensing.
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. dont be vague as well
Competition
Can we actually talk about specific competitor drugs – use these –
https://ascopubs.org/doi/10.1200/JCO.19.01638
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042720/
Sales Forecast-“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.
Differentiation
Market Size
c.Top competitors
orphan drug status about CT-189
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?)
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.
You can mention Merck pharma because they are testing Pembro in mCRPC.