1. Vittorio Chiesa, 2003 Bioscienze ed economia Vittorio Chiesa Università degli studi di Milano-Bicocca FAST Milano, 14 marzo 2003 Convegno Science Generation

2. Vittorio Chiesa, 2003 Index The healthcare context The role of biotech A worldwide overview on biotech industry The Italian situation

3. Vittorio Chiesa, 2003 Index The healthcare context The role of biotech A worldwide overview on biotech industry The Italian situation

4. Vittorio Chiesa, 2003 The healthcare context Increasing level of competition Patent expiration Industry performance indicators decline

5. Vittorio Chiesa, 2003 Inderall®1965 Tagamet®1977 Capoten® 1980 Seldane ®1985 AZT® 1987 Mevacor® 1987 Prozac® 1988 Dillucan® 1990 Recombinate® 1992 Invirase® 1995 Celebrex® 1999 Lopresor® 1975 Zantac®1983 Vasotec® 1985 Hismanial®1989 Videx® 1991 Pravachol® 1991 Zoloft® 1992 Sporanox® 1992 Kogenale® 1993 Norvi® 1996 Vioxx® 1999 Increasing level of competition

6. Vittorio Chiesa, 2003 Patent expiration Number of expiring patents 2001 53 2002 41 2003 58 2004 46 Generic products strongly penetrate (50% of prescription drugs in US) Revenues decrease by 75% in three months since outpatenting 40 bln $ of revenues will disappear in the next 5 years

7. Vittorio Chiesa, 2003 Performance indicators decline Although R&D expenses grow continuously 199219972001 11 bln$18 bln$35 bln$ New drug approval decreases Post-marketing product withdrawals grow Sales growth declines (9% in the 90ies vs. 5.3% foreseen in the first decade of the 2000)

8. Vittorio Chiesa, 2003 The traditional paradigm is over Development of blockbusters (at least 1bln$ of revenues) General-purpose products Aggressive marketing

9. Vittorio Chiesa, 2003 A new paradigm is required: targeted treatments Disease-centric approach to drug discovery Cover of secondary care Combination of products and services (self- diagnosis, patient training and education, disease management) Targeted marketing

10. Vittorio Chiesa, 2003 The new paradigm means stronger market pressure Earlier contacts with regulatory authorities Continuous evaluation and stringent reviews Shifting balance of power (to MCO) Pricing fixed on the basis of medical results

11. Vittorio Chiesa, 2003 The new paradigm is challenging Higher costs of development (clinical trials) Lower selling volumes per drug Lower price but Higher number of new and more effective drugs

12. Vittorio Chiesa, 2003 Index The healthcare context The role of biotech A worldwide overview on biotech industry The Italian situation

13. Vittorio Chiesa, 2003 The new paradigm means a new approach to R&D Drug Discovery Drug Development Production & Commercialization Approval Understanding the disease at molecular level in drug discovery Modeling and simulation in drug development R&D

14. Vittorio Chiesa, 2003 The new paradigm means a great opportunity for biotech companies Drug Discovery Drug Development Production & Commercialization Approval Enabling technology providers Big Pharma Midsize Pharma Big Biotech Small Biotech

15. Vittorio Chiesa, 2003 Index The healthcare context The role of biotech A worldwide overview on biotech industry The Italian situation

16. Vittorio Chiesa, 2003 The biotech industry in US and EU Data 2001 in millions $

17. Vittorio Chiesa, 2003 Biotech in Europe Number of Companies

18. Vittorio Chiesa, 2003 Biotech clusters in Europe

19. Vittorio Chiesa, 2003 What is a cluster A cluster is a geographical concentration of actors in vertical and horizontal relationships, showing a clear tendency of co-operating and of sharing their competences, all involved in a localized infrastructure of support In a cluster co-exist small biotech firms, R&D labs of large firms, universities and research centres, financial institutions, service companies, public support structures

20. Vittorio Chiesa, 2003 Advantages from clustering Sharing of knowledge, competencies and practices Availability of skills Collaboration Support infrastructure

21. Vittorio Chiesa, 2003 Growth mechanisms of a cluster Excellent Scientific Base Generation of Start-ups and Spin-offs Establishment of large firm sites Reinforcement of relations between Industry and Science Growth of the scientific base The trigger is facilitating the generation of new science-based companies

22. Vittorio Chiesa, 2003 How clusters were born In US and UK, there were the conditions for the growth of a cluster: –excellent scientific base –strong enterpreneurial culture –propensity of finance to risky investments In other countries (Germany, France, Scandinavian area) the public support helped create the conditions for the growth of a cluster

23. Vittorio Chiesa, 2003 Index The healthcare context The role of biotech A worldwide overview on biotech industry The Italian situation

24. Vittorio Chiesa, 2003 Biotech industry in Italy and Lombardy

25. Vittorio Chiesa, 2003 What is missing for a biotech cluster in Lombardy Biodevelopment Companies Scientific Base Generation of Start-ups and Spin-offs Mission of a Biodevelopment Company supporting researchers willing to found a new company supporting the management of the project attracting funds hosting the companies in their embryonic phase International cases BiomAG in Munich Genopole in Evry (France) Scientific and Technology Park in Heidelberg Innovation Agencies and University Liaison Offices in Scandinavian countries

26. Vittorio Chiesa, 2003 What we are doing A EU funded project (Cleverbio) to study growth mechanisms and practices of biotech clusters and make a feasibility study for a biodevelopment company A project funded by Fondazione Cariplo to build a network of bioincubators (University of Milano- Bicocca, Parco Tecnologico Padano, European Institute for Oncology - IFOM)