Research European Commission 1 Frontiers of knowledge at the crossroads between life sciences, I.T., engineering An explosion of knowledge Large international genome sequencing programmes e.g. yeast 1996; arabidopsis 2000; listeria 2000; human 2001 Bioinformatics: emergence of a new research field From biosensors to nanobiotechnologies A wide range of applications  Gene therapy (for curing diseases of genetic origin)  Preventive medicine to encourage healthy ageing  Reappraisal of food production systems  Sustainable production of added value molecules  Monitoring biodiversity and eco-system dynamics

Research European Commission 2 ACTION DNA Database Growth and Funding evolution of the European Bioinformatics Institute (EBI) EBI Budget (M€) EC Contribution (M€) DNA Data Base Growth MEuro Giga Bases *Develop a competitive bioinformatics infrastructure in collaboration with the European Investment Fund Generating and exploiting knowledge

Research European Commission 3 Anticipated impacts of technologies on way of life: 2002

Research European Commission 4 European attitudes to six applications of biotechnology

Research European Commission 5 Support and opposition for six applications of biotechnology in 15 countries

Research European Commission 6 THE POLITICAL DRIVE-1 “Towards a European research area” - COM 2000(6) Proposes better framework conditions to foster integration of research activities and coordination of research and innovation policies Lisbon Summit - March 2000 Sets a strategic goal for Europe to become the most competitive and dynamic knowledge-based economy in the world

Research European Commission 7 Stockholm Summit - March 2001 Highlights the importance of research, entrepreneurship... Identifies biotechnology as a frontier technology … and requests the Commission, together with the Council, to examine measures required to utilise the full potential of biotechnology and strengthen the European biotechnology sector's competitiveness THE POLITICAL DRIVE-2 Commission Communication (COM/2002/27)- 23 January 2002 Life Sciences and Biotechnology: a Strategy for Europe. Policy orientations and a 30-point Action Plan.

Research European Commission 8 Barcelona Summit - March 2002 Calls for adoption of the 6 th Framework Programme by June 2002, agrees that research spending in the EU should approach 3% GDP by 2010, with two thirds coming from business, stresses the importance of frontier technologies for future growth and welcomes the Commission's strategic vision for biotechnology and life sciences THE POLITICAL DRIVE-3 European Parliament Damiao Report - 23 October 2002 Endorses the Commission Strategy and Action Plan. Calls for lifting the GMO moratorium in order to stimulate research and innovation.

Research European Commission 9 Competitiveness Council Conclusions - 26 November 2002 Strongly endorses Commission’s Action Plan. Adopts Road Map, setting specific objectives for Community and Member States levels. Timetable for Implementation. THE POLITICAL DRIVE-4 Commission Communication of March 2003 Progress report and future orientations Commission staff working paper on Commission actions

Research European Commission 10 HARVESTING the POTENTIAL 1 GOVERNING Life Sciences and Biotechnology2 3RESPONDING to GLOBAL challenges 4 Implementation and COHERENCE across policies, sectors and actors Who? How? EC + EP + COUNCIL + MEMBER STATES + REGIONS + PRIVATE SECTOR + ACADEMIA + PROFESSIONAL ASSOCIATIONS + CIVIL SOCIETY + EIB + EFSA + EMEA + EGE... The Life Sciences and Biotechnology : a Strategy for Europe Action Plan

Research European Commission 11 A European Strategy for Life Sciences and Biotechnology: The Action Plan - COM (2002) Harvesting the Potential lThe resource Base -investing in people -generating and exploiting knowledge -intellectual property protection -capital base lNetworking Europe’s Biotechnology Communities lA pro-active role for public authorities 2. Governing Life Sciences and Biotechnology lSocietal scrutiny and dialogue lDeveloping Life Sciences and Biotechnology in harmony with ethical values and social goals lDemand-driven applications through informed choice lConfidence in science-based regulatory oversight 3. Responding to global challenge lA European agenda for international collaboration lEurope’s responsibilities towards the developing world 4. Implementation and coherence across policies, sectors and actors

Research European Commission 12 Life Sciences and Biotechnology Strategy Action 2b Investing in Researchers CHALLENGES  Brain drain of scientists and entrepreneurs  Lack of specialised workforce in industry M€ for human resources and mobility in FP6 (from 858 M€ in FP5) with emphasis on return grants M€ for human resources and mobility in FP6 (from 858 M€ in FP5) with emphasis on return grants ACTIONS  Develop and train a skilled workforce  Promote continuing education  Attract scientists to Europe

Research European Commission 13 Life Sciences, Genomics & biotechnology for health Life Sciences and Biotechnology Strategy Action 3: Research Life Sciences, Genomics and Biotechnology for Health Advanced Genomics and its applications for health – Fundamental knowledge and basic tools for functional genomics in all organisms (Structural genomics; proteomics; comparative genomics; bioinformatics; Multidisciplinary genomics approaches to basic biological processes) – Application of knowledge and technologies in the field of genomics and biotechnology for health (Industrial platforms; support to start-up companies) Combating major diseases – Application-oriented approach to medical genomics knowledge (Cardiovascular disease, diabetes and rare diseases ; resistance to antibiotics ; Studying the brain and combating diseases of the nervous system ; Studying human development and the ageing process) – Broader biomedical approach (cancer, poverty-related infectious diseases) Advanced Genomics and its applications for health – Fundamental knowledge and basic tools for functional genomics in all organisms (Structural genomics; proteomics; comparative genomics; bioinformatics; Multidisciplinary genomics approaches to basic biological processes) – Application of knowledge and technologies in the field of genomics and biotechnology for health (Industrial platforms; support to start-up companies) Combating major diseases – Application-oriented approach to medical genomics knowledge (Cardiovascular disease, diabetes and rare diseases ; resistance to antibiotics ; Studying the brain and combating diseases of the nervous system ; Studying human development and the ageing process) – Broader biomedical approach (cancer, poverty-related infectious diseases)

Research European Commission 14 Advanced Genomics and its applications for health – Application of knowledge and technologies in the field of genomics and biotechnology for health > Rational and accelerated development of new, safer and more effective drugs Screening for drug candidates targeting aberrant molecular signalling in protein phosphorylation pathways Genome-based individualized medicines Genome-based therapeutic drugs for psychiatric disorders Novel antiviral therapeutic molecules targeting virus replication and integration Generation of blood substitutes for critical blood components New drugs targeting G-protein coupled receptors Advanced Genomics and its applications for health – Application of knowledge and technologies in the field of genomics and biotechnology for health > Rational and accelerated development of new, safer and more effective drugs Screening for drug candidates targeting aberrant molecular signalling in protein phosphorylation pathways Genome-based individualized medicines Genome-based therapeutic drugs for psychiatric disorders Novel antiviral therapeutic molecules targeting virus replication and integration Generation of blood substitutes for critical blood components New drugs targeting G-protein coupled receptors Rational and accelerated development of new, safer and more effective drugs IP NoE IP STREP Genomics & biotechnology for health

Research European Commission 15 Advanced Genomics and its applications for health – Application of knowledge and technologies in the field of genomics and biotechnology for health > Development and testing of new preventative and therapeutic tools such as somatic gene and cell therapies and immunotherapies Development and production of cell lines for cell based therapies Optimised allogeneic stem cell transplantation for haematological/ neoplastic diseases New advances in cell based therapies for the regeneration of connective tissue Development of a European databank comprising recent advances in genomics, proteomics and cell biology for immunotherapies Stem cell products for myocardial repair Development of vaccine technologies targeted to dendritic cells Advanced Genomics and its applications for health – Application of knowledge and technologies in the field of genomics and biotechnology for health > Development and testing of new preventative and therapeutic tools such as somatic gene and cell therapies and immunotherapies Development and production of cell lines for cell based therapies Optimised allogeneic stem cell transplantation for haematological/ neoplastic diseases New advances in cell based therapies for the regeneration of connective tissue Development of a European databank comprising recent advances in genomics, proteomics and cell biology for immunotherapies Stem cell products for myocardial repair Development of vaccine technologies targeted to dendritic cells Development and testing of new preventative and therapeutic tools such as somatic gene and cell therapies and immunotherapies IP STREP Genomics & biotechnology for health

Research European Commission 16 Structural proteomics in Europe 17 Partners: leaders in the field (10 countries: UK, FR, IT, DE, PT, SE, DK, NL, IS, HE) EC contribution 13.7 m€ Development of technological platforms permitting high throughput structure determination Determining the 3D structure of +500 medically relevant proteins Establishment of a robust, interactive, and open network of European centres of excellence, integrating national, international efforts - academic labs and biotech SMEs. Provision of the necessary training environments for young scientists and technicians Goals

Research European Commission 17 Structural Proteomics in Europe Scientific Advisory Board Executive Committee Training Networking Research Biotech SME Biological Targets viral, bacteria, cancer, etc Biotech SME Biotech SME Biotech SME Technical Platforms crystallisation, X-Ray, NMR... Biotech SME Biotech SME  develop technologies for high throughput 3D structure determination of +500 medically relevant proteins

Research European Commission 18 Integrating European Research Priority Thematic Areas Food Quality and Safety Citizens & governance in the knowledge society Epidemiology of food related diseases Impact of food (including GMOs) on health Traceability processes (including GMOs) Methods of Analysis/Detection/Control Safer and environmentally friendly production/processing methods Impact of animal feed on health Environmental health risks Epidemiology of food related diseases Impact of food (including GMOs) on health Traceability processes (including GMOs) Methods of Analysis/Detection/Control Safer and environmentally friendly production/processing methods Impact of animal feed on health Environmental health risks Life Sciences and Biotechnology Strategy Action 3 Research : Food Quality and Safety

Research European Commission 19 Total Cost: 17 M€ EC Contribution: 12 M€ Partners: 64 Cluster of research projects on the development of probiotic foods FP5 Cluster Coordination PROEUHEALTH Basic mechanisms Research tools Health effects Technology aspects Science Platform Scientific Audience Industry Platform Commercial Audience Consumer Platform Consumer Audience

Research European Commission 20 Life Sciences and Biotechnology Strategy - Action 3: Research Generating and exploiting knowledge Opportunities for SMEs in FP6  Within many of the seven thematic priorities 15% of the budget is reserved for SMEs!  Specific measures for SMEs: CRAFT and Collective Research ~ €100 mio will go to life science related projects  Support for hosting post-docs: Industry fellowships The budget for mobility grants has almost doubled from FP5 to FP6!

Research European Commission 21 Life Sciences and Biotechnology Strategy Action 5 : Intellectual Property Protection CHALLENGES  Need for an effective, affordable and accessible European intellectual property protection system 5 % Overall EPO patenting annual growth rate ( ) 13 % Biotech ACTIONS  Adoption of a Community Patent Regulation  Transposition of the Biotechnology Patent Directive  Awareness and training in strategic use of IPR

Research European Commission 22 Life Sciences and Biotechnology Strategy Action 6 : Capital base The Innovation 2000 Initiative of the European Investment Bank € billion for lending and € 1 billion for developing VC operations in the areas: -development of SMEs and entrepreneurship -diffusion of innovation -research and development -ICT networks -human capital formation The EIB and the Life Science programs are working closely together to identify financing opportunities, in particular for biotech SMEs

Research European Commission 23 Life Sciences and Biotechnology Strategy Action 7: Capital Base Biotechnology & Finance Forum « Biotechnology & Finance Forum » was set up by the Commission and EASD (European Association of Securities Dealers) in 1997 to ensure the mobilization and networking of the European research, industry and finance stakeholders in biotechnology 4 pan European conferences in Brussels (98), Lyon (99), Cambridge (00), Paris (01) (next: Munich Feb 03) support for setting up biotech companies and networking of biotech clusters inclusion of major stakeholders into the BFF advisory board 2002: EuropaBio, EFB, EIB, EIF, EVCA, APCIMS/EASD

Research European Commission Biotechnology companies in Europe in 2001 (US 1457) - Tripled in number in 5 years Life Sciences and Biotechnology Strategy Action 8a Networking

Research European Commission 25 “Bio-entrepreneurship: Networking of Biotechnology Clusters in Europe” lBiotech start-ups are not “regional companies”. They have needs - scientific, financial, market, management - requiring European assistance. Life Sciences and Biotechnology Strategy Action 9b : Networking lNeed for networking of bioclusters across Europe (e.g. exchange of best practise, skills, critical mass) - if successful entrepreneurship in biotechnology is to be promoted rapidly and efficiently.

Research European Commission 26 Life Sciences and Biotechnology Strategy Action 9b Networking Trans-national biotechnology clusters: 3 examples BIOVALLEY® in upper rhine region: (Northwest Switzerland, CH + South Baden, DE + Alsace, FR) EUREGIO: Meuse-Rhine region Maastricht, NL + Aachen, DE + Liège, BE MEDICON VALLEY: Öresund region (Southern part of Sweden, SE + Greater Copenhagen, DK)

Research European Commission 27 Challenges: Enhancing public understanding and perceptions of life sciences and biotechnology. Stakeholders Scientists Industry Civil Society Interest Groups European Group of Life Scientists Life Sciences and Biotechnology Strategy Action 13: Societal scrutiny and dialogue Actions: Support science communication and dialogue with the public. Monitor public perceptions : Eurobarometer, focus groups. Encourage civil society involvement: support European citizen networks.

Research European Commission 28 European Research Strategy – Role of Strategic Accompanying Measures Towards a European Research Area (2000) Life Sciences and Biotechnology – A Strategy for Europe (2002) An integrated plan for the beneficial development and responsible governance of life sciences and biotechnology in Europe and world-wide Science and Society (2002) Seeking closer relationships between the citizens and science White Paper on European Governance (2001) A broad strategy for a sound, responsible and participative governance, including research policies

Research European Commission 29 European Research Strategy – Role of Strategic Accompanying Measures In FP5, the Strategic Accompanying Measures have succeeded in setting the research projects against a broader background – especially in considering:  the needs and perceptions of ordinary citizens  the interests of other stakeholders  the use of foresight to develop sound science with consideration to society's needs The next slides offer best practice examples of projects that have harnessed Strategic Accompanying Measures

Research European Commission 30 CONSENSUS WORKSHOPS Identifying and defining consensus on key food issues Bridging the gap between consumers, scientists and stakeholders from the food chain through three international workshops, running from The workshops cover the following themes: Food safety (June 2002) Novel foods (February 2003) Nutrition (July 2003) The presentations and outcomes of the workshops are published on the consensus workshop website: Consensus forming

Research European Commission 31 BIO-TEACH-WORK Continuing education for EU biology teachers The Bio-Teach-Work project aims to make available the skills and resources of research scientists to the European Union’s biology teachers. Three main activities:  Workshops offering both theoretical and practical training for biology teachers  A training programme for scientists and teachers – developing new resources; sharing best practice  Creating a resource centre and archive for teaching materials Popularisation of life sciences - Education

Research European Commission 32 GMO RES COM Biosafety research communication The three-year project aims at improving communication and public dialogue on biosafety by:  Supporting a new journal on the biosafety of GMOs  Supporting a series of international symposia on the safety of GMOs  Creating a web-based, publicly accessible database on GMO safety research Issues being addressed by this accompanying measure:  Meeting the need for a coordinated research effort  Efficient exchange of information to scientists and the public Consensus forming - Support to policies

Research European Commission 33 SCIENCE GENERATION Bridging the gap between the science and the citizens Towards a EU network of citizens for a participative governance of life sciences bringing together students, teachers, parents, scientists, economists, lawyers, policy makers and other stakeholders,  Aims to improve communication,education, public awareness and consideration of public perceptionsrelating to biosciences and society  Enabling ordinary citizens to become involved and proactive in biosciences and the implications that can affect their future  Pilote EU experience active in three countries: France, Italy and Sweden Popularisation of life sciences - Public dialogue

Research European Commission 34 Challenges: To develop life sciences and biotechnology in a responsible manner: in harmony with ethical values and societal goals, while respecting cultural pluralism. Life Sciences and Biotechnology Strategy Action 14: Harmony with ethical values and societal goals Topics: Xenotransplantation Human embryonic stem cells Biobanks Gene testing Actions: Research into socio-economic and ethical issues and development of assessment criteria. Consider ethical, social and legal aspects of new developments. Attempt consensus on ethical guidelines.

Research European Commission 35 Bio-T-Ethics Biotechnology ethics – a vital discipline for the 21 st century A strategic initiative to contribute research efforts and education in biotechnology ethics. Foremost authorities on biotechnology ethics from 11 countries, in consultation with stakeholders, will:  Define aspects of the biology-industry interface requiring ethical expertise  Organise studies to improve communications and application of ethics  Find ways to transfer the ethics research into education  Organise pillote courses on biotechnology ethics … towards a European School for Biotechnology Ethics Education - Ethical principles

Research European Commission 36 FNIBI Teaching ethics Consideration to ethics in the life sciences research and education is a key principle of the EU research policies This measure runs workshops to train life scientists to integrate ethics into their courses and laboratories  A EU-US joint effort by the FLAD/NSF International Bioethics Institute  Three courses run to date, with teachers from the USA and Europe  Use of ‘active learning’ methods Training - Ethical principles

Research European Commission 37 Success will depend on mobilisation of all actors Ethical Bodies Parliament Commission Member States Regions European Investment Bank Private Sector Academia Civil Society RESEARCHDEVELOPMENTREGULATION DELIVERABLES FOR SOCIETY

Research European Commission 38 The European Group on Life Sciences Established by Commissioner P. Busquin in April 2000, with the mandate of: providing high level advice on the current situation and foreseeable developments in the field of life sciences supporting broad science-communication strategies, particularly by organising a Life Sciences Discussion Platform Members 2002 Members 2002 : V. De Lorenzo (E) (Chair), D. Burke (UK), P. Cunningham (IRL), L. Kovac (SK), P. Kourilsky (F), C. Nüsslein-Volhard (D), A. Mc Laren (UK), N Rosentahl (USA- I), J. van Bemmel (NL), M. van Montagu (B), L. Santi (I), H. Wigzell (S), E-L Winnacker (D)

Research European Commission 39 LIFE SCIENCES DISCUSSION PLATFORMS SCIENTISTS, INDUSTRY, CIVIL SOCIETY, YOUTH, INTEREST GROUPS, MEDIA, POLICY MAKERS... STEM CELLS: THERAPIES FOR THE FUTURE? TOWARDS SUSTAINABLE AGRICULTURE FOR DEVELOPING COUNTRIES: OPTIONS FROM LIFE SCIENCES AND BIOTECHNOLOGY GENETICS AND THE FUTURE OF EUROPE * Multiple Stakeholders * Reciprocal Information * Questions, Debate EGLS