These special reports are based on the DDS Matching Symposium, which has been held for three times at the annual meetings of the Japan Society of Drug Delivery System. The objective of this symposium is to discuss how to materialize great technologies and achievements, which are created and accomplished by researchers in Academia, into practical use. The key to establish "win-win relationship" between Academia and industries, provider and recipient of the result of fundamental research, is to spur collaboration and coordination in R&D based on their common understanding of the concept of open innovation. As an introduction of the following special reports, this paper reviews this series of symposiums.

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In 2001, the Ministry of Economy, Trade and Industry (METI), Japan announced the "1000 University-Originated Ventures Plan". A cumulative total of 1,000 companies at the end of 2004 and a total of 1,500 companies at the end of 2005 were established. Among them, there were many drug-discovery ventures including DDS technology-specialized ventures, but very few ventures have survived so far, which often quitted drug discovery unfortunately even if they still exist. Also, since 2011, the establishment of a university-originated venture is rekindling, but IT-based venture is the main, and drug discovery-based venture including DDS-specialized venture remains small. In this review, I will describe an account of the DDS technology-specialized drug-discovery venture established by us in 2002, point out the issues in entrepreneurization and commercialization of academic research-based DDS technology, and would like to make proposals leading to the success of forthcoming DDS technology-specialized drug-discovery ventures.

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Under the current environment creating new value through collaboration by different organizations, intellectual property strategy which is commonly required to academia and business enterprises exists on mutual trust as a partner for co-creation. The role of intellectual property has been changing from conventional functions, such as protecting the results of research and development from copying, to strategic business assets for creating new businesses and evolving companies. This article describes one of the opinions with respect to intellectual property strategy for business enterprises to commercialize advanced technologies or other research results discovered or conceived by academia.

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Venture capitals(VC) are investing in ventures with high growth potential providing a product and service through new technology and business model. In Japan, many ventures with a DDS (Drug delivery system) technology (DDS ventures) have established, and some of them have carried out the clinical trial of their pipeline. As a place to invest in VC, I propose the following three important points in the DDS venture business growth. 1) For the pharmaceutical company, the attractiveness as a product itself with their DDS technology is more valuable than the superiority of their DDS technology. 2) As for the DDS ventures, the manufacturing process of materials of DDS and the bulk of products with DDS becomes the big hurdle in research and development (R&D). 3) DDS ventures need to build a development strategy with a product approval and entry into the market.In trends of the open innovation in the drug discovery and development in academia or pharmaceutical companies, I recognize this situation as one of the investment opportunities and will have deep interest in ever more and want to be involved in DDS technology and drug candidates.

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The global pharmaceutical market was analyzed by monitoring companies’ financial results and aggregating product sales for each therapeutic categories. Cancer came to the top and autoimmune the second, while CVM dropped from the top to the third. Rapid growth was observed in the categories where pharmacological targets were newly identified for diseases with unmet medical needs. Launch of anti-PD1 products drastically changed treatment of lung cancer where antibody drugs were scarce. On the contrary, molecular-targeted drugs such as orally available CDK4/6 inhibitors changed breast cancer treatment where antibody drugs were dominant. Also in autoimmune diseases, new pharmacological targets such as IL-17A, IL-23, and integrin were identified. Oral JAK inhibitors to treat rheumatoid arthritis, and new targets such as CD-38, SLAMF7, and HDAC in multiple sclerosis were good examples of innovative pharmacology targets.

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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.

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It is said that there is the Death Valley on the way for the practical use of academia-originated novel technology. In order to build the rainbow bridge across the valley, the following key points, “originality, innovativeness and adequacy of technology”, “reproducibility and reliability of data”, “patent strategy (acquisition of intellectual property rights) in the world”, “financing arrangements”, “organizational support” and “use of open innovation platform and research network (human network)” are considered very important and requisite. If any of the above key points lacks, the practical use of academia-originated technology may become impossible.

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