Abstract
Newly advanced DDS technologies would provide added value to original products without the new DDS by demonstrating superior clinical effects, safety profile, easiness of the use, etc. On the other hand, there would be (1) many technical issues to realize the new DDS and (2) many issues to evaluate commercial value such as underestimate of DDS resulting in opportunity losses. We should like to increase accuracy or reliability of the evaluation to avoid the opportunity losses that (1) significantly discourage R&D personnel and (2) waist R&D resources and valuable time. Protein-Protein-Interaction (PPI) is essential in drug discovery. While another PPI (Person-Person-Interaction) is essential to increase accuracy or reliability of the evaluation by sharing its transparent process for individual members of R&D Project Teams to openly discuss to overcome the major issues by using different strengths of the individuals. I like to share the process, major elements to increase/decrease commercial value of R&D projects including DDS and licensing issues with you. This paper consists of (1) Introduction, (2) Value creation of drug discovery/DDS, (3) How to evaluate commercial value of R&D projects, (4) major variables to increase/decrease the value, (5) Value optimization of DDS reflecting right formulation, right place and right time, (6) Reasons for different value of the one project reflecting different persons and/or different pharma companies, (7) Recommendation for academia to optimize the value of DDS and (8) Closing. We usually conduct commercial evaluation of R&D projects for GO/No-go based on limited data such as scientific, technological, epidemiological & market data and many assumptions including Target Product Profile (TPP). We conduct market research including product concept by using TPP. We specifically design Quantitative Forecasting Model (FM) for each specific product based on implications of the market research and others. We should specifically design FM for specific Product-X reflecting its specificities and anticipated entry market (such as Best-in-Class) or emerging market (1st-in-Class). Marketing and reimbursement strategies are almost totally different with each other. Use of duplicated FM leads to high risk of underestimate or overestimate which we should avoid. I desire optimum understanding and use of the contents for value optimization of DDS.
