VALORISATION: THE SOCIETAL IMPACT OF KNOWLEDGE

VALORISATION: THE SOCIETAL IMPACT OF KNOWLEDGE

prof.eric.claassen@gmail.com 10% ACADEMIC-90% ENTREPRENEUR CHAIR Businessmanagement and Entrepreneurship in the Life Sciences VRIJE UNIVERSITEIT Amsterdam (2001..) MEDICAL FACULTY ERASMUS UNIVERSITY ROTTERDAM Director Erasmus Centre for Valorisation (1994.) ENTREPRENEUR IN RESIDENCE ROTTERDAM SCHOOL OF MANAGEMENT (BEDRIJFSKUNDE; 2006-.) UNIVERSITE DE PARIS & INSTITUT PASTEUR PARIS (1992..)

Ebola: Public-Private Partnerships Reperant, van de Burgwal, Claassen & Osterhaus Science 24 Oct 2014 VOL 346 ISSUE 6208 pages 433-434

1. Full range: Societal impact of knowledge has four pillars Knowledge for knowledge (scientific, curiosity-driven research) Knowledge for welfare ( ) (products or services) Knowledge for wellbeing (policy advice, guidelines) Knowledge for culture (dissemination to and involvement of the general public)

Disrupted and/or Incomplete Value Chains

publication (scientific / layman s / professional) book courses report (policy / advisory) guideline database instrumenten / tools patent designs software product service

Activities from Society Perspective

Societal valorisation bias: fatal shortcut

The effect of Social Valorisation Bias 85% of TTO income is from 10% of universities.

12. Unmet Needs Assessment Consortium Qualitative interviews: identification Identification and in-depth understanding of unmet needs Quantitative questionnaires: prioritization Quantitative ranking of most important unmet needs Demand Articulation Professionals Industry Citizens / end-users Policy makers Key Opinion Leaders

Activities from Business Development Perspective

pilotitis

4. Value Chain Charting Industry specific success rate: x% Industry specific success rate: x% Value Chain Pilot Evaluation Upscaling Step 1 Step 1 Step 1 Step 2 Step 2 Step 2 Step 3 Step 3 Step 3

Frontloading the Cash Market Entry Royalty payments over drug revenues Milestone payments Revenues Upfront payment years to milestone Time years to royalty royalty period 28

Partnerships are becoming more prominent

Societal Valorisation Hard Valorisation Knowledge work facility Initial Education Fundamental research

3. Tailored: scientifically validated methods 12. Unmet needs assessment 1. Charting technology field 2. Barriers to innovation 3. IP strategies in specific markets 10. Competitive analysis 11. Market analysis and forecasting 4. Value Chain charting 5. Cost-effectiveness analysis 6. Funding strategy 7. Fundability strategy 8. Team analysis 9. Business model development

Societal Impact of Knowledge in Horizon 2020 As stated by the European Commisison, in order to be eligible for European funding, a research proposal should contain dissemination and exploitation measures that: 1. address the full range of potential users and address the full range of potential applications, including research, commercial, investment, social, environmental, policy making, setting standards, skills and educational training. 2. Furthermore, the approach to innovation should be as comprehensive as possible, 3. And must be tailored to the specific technical, market and organisational issues to be addressed.

Disrupted and/or Incomplete Value Chains

Slides for discussion & information

2014 papers: 200 Weenen TC, Pronker ES, Fernald KDS, Claassen E, Commandeur H. Bridging a pharma-like innovation gap in medical nutrition. 2014. Springer Book Series - Advances in Pharmaceutical Sciences. 201 Mekkes, M.C., Weenen T.C., Brummer R.J., Claassen E. The development of probiotic treatment in obesity: a review. Beneficial Microbes. 2014 Mar;5(1):19-28. 202 Weenen, T.C., Jentink, A., Pronker, E.S., Commandeur, Claassen, E., H.R., Boirie, Y., Singer, P. Patient needs and research priorities in the enteral nutrition market a quantitative prioritization analysis. Clinical Nutrition 2014. 33(5): 793-801. 203 Van den Nieuwboer, M., E. Claassen, L. Morelli, F. Guarner, and R.J. Brummer. (2014) Probiotic and Synbiotic safety in infants under two years of age. Beneficial Microbes. In press Beneficial Microbes. 204 Claassen E (2014) Cost-benefit relation of diet and probiotics in iatrogenic bowel irregularity (IBI).. Front. Pharmacol. 5:14. doi:10.3389/fphar.2014.00014 205 E. Pronker, et al., Scratching the surface: Exploratory analysis of key opinion leaders on rate limiting factors in novel adjuvanted-vaccine.., Technol. Forecast. Soc. Change (2014), http://dx.doi.org/10.1016/j.techfore.2014.04.017 206 Weenen, T. C., Commandeur H and Claassen E., A critical look at medical nutrition terminology and definitions, Trends in Food Science & Technology (2014), http://dx.doi.org/10.1016/j.tifs.2014.04.004 207 Van den Nieuwboer, M., Brummer, R.J., Guarner, F., Morelli, L., Cabana, M., and Claassen, E (2104) The administration of Probiotics and Synbiotics in Immune Compromised Adults: is it Safe? Beneficial Microbes, in press 208 Fernald, K. Pennings E. and Claassen E. (2014) Biotechnology Commercialization Strategies: Risk and Return in interfirm cooperation. J. Prod. Innov. Manag. DOI 10.1111/jpim 12218 209 Dehzad, F., Hilhorst, C., de Bie, C. and Claassen, E. (2014) Adopting Health Apps, What s Hindering Doctors and Patients? Health, 6, 2204-2217. http://dx.doi.org/10.4236/health.2014.616256 210 Reperant LA, van de Burgwal LH, Claassen E, Osterhaus ADME. Ebola: public-private partnerships. Science. 2014 Oct 24;346(6208):433-4. doi: 10.1126/science.346.6208.433-b 211 Nuijten M., Josbert J. Keller, Caroline E. Visser, Ken Redekop, Eric Claassen, Peter Speelman and Marja. H. Pronk. Costeffectiveness in Clostridium difficile treatment decision-making Guidance on standardization. World Journal of Clinical Cases. in press. 212 Van den Nieuwboer, M., Brummer, R.J., Guarner, F., Morelli, L., Cabana, M., and Claassen, E. Safety of Probiotics and Synbiotics in Children Under 18 Years of Age. Beneficial Microbes, in press 213 Van den Nieuwboer Maurits., Saskia van Hemert, Eric Claassen and Willem M. de Vos. Lactobacillus plantarum WCFS1: 10 Years After The Genome. Microbial Biotechnology. in press. 214 Van den NieuwboerM,, A. Klomp-Hogeterp, S. Verdoorn, L. Metsemakers-Brameijer, T. M.Vriend, E. Claassen and O.F.A. Larsen. Improving the bowel habits of elderly residents in a nursing home using probiotic fermented milk. Beneficial Microbes, in press. 215 Ramezanpour, B., Pronker E.S., Kreijtz J.H.C.M., Osterhaus A.D.M.E. and Claassen E. Market Implementation of the MVA Platform for Pre-pandemic and Pandemic Influenza Vaccines: A Quantitative Key Opinion Leader Analysis. Vaccine, in press.

The role of the ECV Academic Consortium Partner Academic Consortium Partner Exploitation Consortium Partner: ECV Industry Consortium Partner Dissemination Consortium Partner

Process of articulating impact section Starting point: the academic research within a proposal Considering the full range of potential applications (in all four domains) Identifying the current status of the research within the societal impact value cycle Assessment of methods necessary to address the full range of potential applications

3. IP Strategies in Specific Industries Based on an interactive approach, different industry-specific IP strategies are identified and a decision framework is developed to establish an optimal route for IP protection. The main focus for determining such an optimal route for IP protection is: maximum dissemination while taking into account maximum exploitation opportunities of research results. We will consider the full scope of IP possibilities (from patents to trademarks to copyrights), therefore this analysis is relevant in the exploitation of results from all fields of science and knowledge production. Deliverables An IP decision framework for a specific industry or field. Weenen, T. C., Jentink, A., Pronker, E. S., Commandeur, H. R., & Claassen, E. (2013). A decision framework to evaluate intellectual property strategies in the medical nutrition market. PharmaNutrition, 1(2), 65-72.

3. IP Strategies in Specific Industries - example of results Weenen, T. C., Jentink, A., Pronker, E. S., Commandeur, H. R., & Claassen, E. (2013). A decision framework to evaluate intellectual property strategies in the medical nutrition market. PharmaNutrition, 1(2), 65-72.

6. Funding Strategy

importance / value importance / value 12. Unmet Needs Assessment - example of results improvement priority improvement priority KOL PERSPECTIVE END-USER PERSPECTIVE Weenen, T. C., Jentink, A., Pronker, E. S., Commandeur, H. R., Claassen, E., Boirie, Y., & Singer, P. (2013). Patient needs and research priorities in the enteral nutrition market A quantitative prioritization analysis. Clinical Nutrition.

1. Charting Technology Field An overview of the technology and innovation field is vital in understanding the current state-of-art and ways in which research results are developed into innovations. In this work package the technology field is charted by analysing activities in 3-4 domains: Knowledge in literature Products in development Registered IP Products on the Market Weenen, T. C., Ramezanpour, B., Pronker, E. S., Commandeur, H., & Claassen, E. (2013). Food-Pharma Convergence in Medical Nutrition Best of Both Worlds? Plos One, 8(12), e82609. doi: 10.1371/journal.pone.0082609 Ramezanpour et al., forthcoming

1. Charting Technology Field 1.Literature 2. Intellectual Property 3. Products in development 4. Products on the market Input A systematic review of relevant literature in collaboration with the (scientific) experts. Based on a proprietary method, we analyze patents to identify trends and developments within specific technology fields. With this method we determine opportunities and potential challenges. In fields that require clinical trials, a complete overview of products in development is generated. By analysing marketed products (in pharmaceutical fields: approved and registered), an overview is generated of known market opportunities. Deliverable An overview of the most recent (technological) developments An overview of the commercially most promising (technological) developments An analysis of industry level development trends

2. Barriers to Innovation For a specific innovation to reach the market, a number of barriers have to be overcome. Research has shown that focusing on the most important barriers is the most efficient and effective way to reach innovation. In order to aid in this process, we have developed a proprietary model of analysis to identify and prioritize innovation barriers. This model can be applied in different fields of science and technology, but also to barriers regarding the impact of innovation in society. Deliverables Identification and in-depth understanding of innovation barriers Relative prioritization of innovation barriers Strategy to overcome innovation barriers Weenen, T. C., Pronker, E. S., Commandeur, H. R., & Claassen, E. H. J. M. (2013). Barriers to innovation in the medical nutrition industry: A quantitative key opinion leader analysis. PharmaNutrition, 1(3), 79-85. Pronker, E., Weenen, T., Commandeur, H., Claassen, E., & Osterhaus, A. D. M. E. (2014). Scratching the surface: Exploratory analysis of key opinion leaders on rate limiting factors in novel adjuvanted-vaccine development. Technological Forecasting and Social Change. doi: 10.1016/j.techfore.2014.04.017

4. Value Chain Charting Industry specific success rate: x% Industry specific success rate: x% Value Chain Pilot Evaluation Upscaling Step 1 Step 1 Step 1 Step 2 Step 2 Step 2 Step 3 Step 3 Step 3

5. Cost-effectiveness Analysis for Innovations Cost-effectiveness of innovations is a vital condition to ensure that an innovation is adapted by multi-stakeholder systems. A timely analysis of cost-effectiveness is therefore an important step in any innovation chain. The benefits of such an analysis may differ for different stakeholders: Government Hospital Industry reimbursement decisions; pricing decisions clinical guidelines, reimbursement positioning and marketing purposes, R&D decisions Health care providers Health insurers Doctors Patients good access to innovations for their clients, affordability and reimbursement strategies use of innovations access to innovations Patient / Customer Payer Deliverable: An early insight in cost-effectiveness and corresponding chances of successful implementation of innovations

5. Cost-effectiveness Analysis for Innovations New treatment strategies or interventions Analysis of: Cost-of-illness and (micro-) costing Economic evaluation Early-HTA Late-phase studies and real-world evidence Patient registries Meta-analysis Decision-analytic modeling Value of information analysis Multi-criteria decision analysis Reimbursement policy analysis Health status and patientreported outcomes Preference measurement Broad societal benefits Cost-effectiveness Blommestein, H. M., Issa, D. E., Pompen, M., Ten Hoor, G., Hogendoorn, M., Joosten, P., Uyl-de Groot, C. A. (2014). Cost-effectiveness of rituximab as maintenance treatment for relapsed follicular lymphoma: results of a population-based study. European Journal of Haematology, 92(5), 398-406. Goossens, L. M. A., Utens, C. M. A., Smeenk, F. W. J. M., van Schayck, O. C. P., van Vliet, M., van Litsenburg, W., Rutten-van Mölken, M. P. M. H. (2013). Cost-Effectiveness of Early Assisted Discharge for COPD Exacerbations in The Netherlands. Value in Health, 16(4), 517-528.

8. Team Analysis Especially during longer term research and innovation projects the demands on knowledge, expertise and steering capacity of the management team of the project are expanding and changing along the way. Which roles and expertise are needed during each phase (also keeping the fundability of the project in mind) and what is already covered by the current candidates? Which additional capacities are needed, and how can these best be obtained (training, advisors, additional recruitment) during the consecutive phases. Deliverables: Analysis of phases of development, and needs during these phases Analysis of current team members, and their future potential Advise on team building

8. Team Analysis Analysis of skills in current team Analysis of needs during phases

9. Business Model Development Results from our analyses can be integrated with existing data from the client and used for the development of a fundable business model This business model may also include potential exit-strategies considering competitor activities and the M&A landscape. Deliverables: An inclusive, acceptable, effective and fundable business model Business Model Foundry 2014 Pronker, E. S., Claassen, E., & Osterhaus, A. D. M. E. (2012). Development of new generation influenza vaccines: recipes for success? Vaccine, 30(51), 7344-7347. doi: 10.1016/j.vaccine.2012.09.071

10. Competitive Analysis A thorough competitive analysis reveals market opportunities, collaboration opportunities, niches and saturated markets. In order to fully understand the competitive landscape, 3 routes complement each other. 1. Product-specific competition analysis Based on the analysis of existing products in development and products on the market, we develop an overview of competitors that are already active in the target market. Deliverables A list of relevant product developers/manufacturers. Insight in products in different geographical areas Insight in product approval status in different geographical areas Ramezanpour et al, forthcoming

10. Competitive Analysis 2. Technology-based competition analysis This analysis generates an overview of patent applicants in the field and thereby a list of potential competitors. Based on patent data, we compile a comprehensive list of all industries active in a specific technological field and their innovation focus. Deliverables A list of relevant patent (application) holders and their innovation focus Insight in patents in different geographical areas Insight in protection status in different geographical areas Weenen, T. C., Pronker, E. S., Commandeur, H. R., & Claassen, E. (2013). Patenting in the European medical nutrition industry: Trends, opportunities and strategies. PharmaNutrition, 1(1), 13-21. doi: 10.1016/j.phanu.2012.10.003 Ramezanpour et al, forthcoming

10. Competitive Analysis 3. Inter-firm cooperation analysis Both relevant patent applicant holders that are revealed by the patent analysis and relevant product developers can subsequently be subject to analysis of inter-firm cooperation. This entails mapping specific types of strategic alliances (e.g. joint ventures, license deals, outsourcing, collaborative R&D), but also M&A deals, amongst relevant patent applicant holders. Results from this analysis can be interesting in determining potential partners as well as exit-strategies. Deliverables An overview for specific types of inter-firm relationships/alliances An overview of the industry s M&A landscape Alliances Mergers & Acquisitions Joint Ventures Collaborative R&D License deals Outsourcing Marketing / distribution Minority equity investments Majority equity investments Mergers Fernald et al., forthcoming

10. Competitive Analysis - example of results Fernald et al., forthcoming

11. Market Analysis Based on KOL analysis and access to market databases, we can perform additional market research and determine marketing strategies. This market research, in combination with other research efforts that can be performed by ECV and existing data or knowledge from the research group / consortium, can serve as the basis of a thoroughly developed business plan. Deliverables Estimations of size of defined target market(s). Sales forecast, including reimbursement possibilities. SWOT analysis. Analysis and advise on marketing strategies.

Returns Investment New Initiatives Top-down (Deans) Bottom-up (Academics / Support Staff) ECV Checklist - Evaluation and Ranking Internal checks ECV and Research group 1. Internal capacity / financed external capacity available 2. Agreed upon specified commitment (time / means) from research group 3. Positive projected (financial / academic / reputational) ROI for ECV and Research Group 4. Investment (times / means) and projected revenues fit cashflow prognosis ECV / research group Political ranking 1. Contributes to diversity projects EUR 2. Potential to become short-term successful showcase 3. Involvement of new hi-po research group Exploratory meetings Project Initiation Document STOP STOP Positive + 1. Academic quality researcher / research group 2. Presence of champion 3. Market Validation 4. Scalability beyond individual researcher 5. IP / FTO check 6..PoC available 7. Short-term revenues exceed time investment 8. Known market / network 9. Contributes to building expertise ECV Project ranking Negative - 1. Large number of external partners / high complexity 2. Turnaround time project > 1 year 3. First revenues > 6 months 4. Time investment ECV > 100 hours 5. Lead phase to go / no-go with no reimbursement guarantee 6. High dependency on third parties Knowledge / Expertise Input Business Developer + Project Leadership Development Steps + Milestones Approval from Dean of Faculty Business Case STOP Organizational structure Value Proposition Customer Segments + Channels Financing Activities STOP Revenues Reputation building Access to data Research Funding Attraction of excellent academics Attraction of excellent students

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