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Convegno Science Generation Bioscienze ed economia Vittorio Chiesa Università degli studi di Milano-Bicocca FAST Milano, 14 marzo 2003 Index The healthcare context The role of biotech A worldwide overview on biotech industry The Italian situation Index The healthcare context

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Convegno Science Generation

Bioscienze ed economia

Vittorio Chiesa

Università degli studi di Milano-Bicocca

FAST

Milano, 14 marzo 2003


Index

  • The healthcare context

  • The role of biotech

  • A worldwide overview on biotech industry

  • The Italian situation


Index

  • The healthcare context

  • The role of biotech

  • A worldwide overview on biotech industry

  • The Italian situation


The healthcare context

  • Increasing level of competition

  • Patent expiration

  • Industry performance indicators decline


Increasing level of competition

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


Patent expiration

  • Generic products strongly penetrate

  • (50% of prescription drugs in US)

    • Revenues decrease by75% in three months since outpatenting

    • 40 bln $ of revenues will disappear in the next 5 years

  • Number of expiring patents

    2001 53 2002 41 2003 58 2004 46


    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)


    The traditional paradigm is over

    • Development of blockbusters (at least 1bln$ of revenues)

    • General-purpose products

    • Aggressive marketing


    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


    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


    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


    Index

    • The healthcare context

    • The role of biotech

    • A worldwide overview on biotech industry

    • The Italian situation


    Drug

    Development

    Drug

    Discovery

    Production

    &

    Commercialization

    The new paradigm meansa new approach to R&D

    R&D

    Approval

    Understanding the disease at molecular level in drug discovery

    Modeling and simulation in drug development


    The new paradigm means a great opportunity for biotech companies

    Drug

    Development

    Drug

    Discovery

    Production

    &

    Commercialization

    Small Biotech

    Big Biotech

    Big Pharma Midsize Pharma

    Approval

    Enabling technology providers


    Index

    • The healthcare context

    • The role of biotech

    • A worldwide overview on biotech industry

    • The Italian situation


    The biotech industry in US and EU

    Data 2001 in millions $


    Biotech in Europe

    Number of Companies


    Biotech clusters in Europe


    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


    Advantages from clustering

    • Sharing of knowledge, competencies and practices

    • Availability of skills

    • Collaboration

    • Support infrastructure


    Growth mechanisms of a cluster

    Generation of Start-ups and Spin-offs

    Excellent Scientific Base

    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


    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


    Index

    • The healthcare context

    • The role of biotech

    • A worldwide overview on biotech industry

    • The Italian situation


    Biotech industry in Italy and Lombardy


    What is missing for a biotech cluster in Lombardy

    Generation of Start-ups and Spin-offs

    Biodevelopment

    Companies

    Scientific

    Base

    • 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


    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)


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