Scientific support for European Industrial Competitiveness

Health, Food and Nutrition

Nathalie Moll, Secretary General, EuropaBio

Roundtable with Chief Scientists of Industry on Scientific Support for European Industrial Competitiveness

15 February 2012Brussels

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About EuropaBio and biotechnology

• EuropaBio is the European Association for Bioindustries;

• Bring together bioscience companies from all fields of R&D, testing, manufacturing and distribution of biotechnology products;

• 60+ corporate members, 7 bioregions, 20 national biotech associations in Europe

According to the OECD, biotechnologyis:

The application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services.

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BiotechnologyA key technology platform

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Healthcare Biotech

Agri Food Biotech

Industrial Biotech

Today, biotechnology is a an enabling technology applied in 3 main sectors:

• The majority of innovative medicines and many diagnostic products , whether manufactured using biotechnology or via a chemical synthesis are produced by applying modern biotechnology in their development and/or manufacturing processes.

• By 2015, healthcare biotechnological knowledge is likely to be used in the development process for all new pharmaceuticals

Biotechnology in healthcareImportant for Research, Development, and Production

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Biotechnology in healthcareUsed in All Areas of Medicine

5Source: PhRMA, Medicines in Development: Biotechnology 2011 Report

Number of biotech products in development by disease category

Industrial BiotechnologyThe Biorefinery concept

Vitamins – B2

Cosmetics Food - Baking

Bio-based Polymers

Dyes for textiles

Biofuels Pulp & paper

AntibioticsCephalexin

Industrial BiotechnologyEnabling the Bioeconomy

→ Agricultural biotechnology includes transgenics (GM) and other applications (non-GM) also known as new breeding techniques

→ GM crops are now cultivated on 160 Mio ha globally (in 2011) by 16.7 Mio farmers in 29 countries of which 19 are developing countries.

→ Non-GM biotech crops are also widely developed and commercialised

→ To date, the main GM crops are herbicide tolerant and/or insect resistant.

→ New GM traits being developed are so-called “2nd generation” traits that focus on consumer benefits and/or improved product/environmental profiles.

Most important R&D activities in Green Biotechnology

• Key trends in Healthcare Biotechnology• Personalised Medicines; Increasingly localised treatments• Advanced therapies (cell and gene therapy, tissue engineering)

• Key trends in Industrial Biotechnology• Breakdown of ligno-cellulosic materials / waste and by-products• Focus on biorefinery development and integration: from feedstock to

end products; Overcoming the innovation death valley

• Key trends in Agricultural biotechnology: according 2009 JRC report “The global pipeline of new GM crops” report:

• New traits with societal benefits e.g. optimized oil & starch content, improved nutrients profiles & drought tolerance.

• New crops by stacking individual events. • New crops or further adoption: potato, rice, sugar beet, brinjal etc.

Key R&D and innovation activities now and in the future

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Healthcare biotechnology• Research supporting the effective use of -omics to

develop better diagnostics and contribute to the development of personalised medicines (proteonomics, pharmacogenomics, functional genomics, bio-informatics, etc…)

• Research into the use of biomarkers, health technologies including e-health, diagnostics, imaging, etc. to help improve these tools and to help integrate them in drug development, regulatory approval and health systems

• Systems pharmacology and research at the level of molecular interractions (incl. Research aimed at increasing our understanding of molecular pathways of diseases, development of a mecanism-based disease classification)

New and emerging areas where scientific support could accelerate innovation (I)

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Industrial Biotechnology• Feedstock

• Find and develop future enzyme activities that refine lignocellulosic biomass or its main fractions

• Production processes• Increase the yield and productivity of biochemical processes

• Develop downstream processing (the separation and purification steps directly after the actual biochemical process)

• Final product• Develop processes that result in higher end product concentrations

New and emerging areas where scientific support could accelerate innovation (II)

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Agricultural BiotechnologyInnovation is stifled not because of lack of scientific support but because of

regulatory hurdles and bottlenecks that:

• Increase cost of product development including regulatory compliance (making it too costly for SMEs to engage in the field)

• Cause unpredictability of the regulatory pathway and outcomes 2011 EuropaBio report “Approvals of GMOs in the European Union”• Authorization system for GMOs not working as it should + significant

approval backlog• Trade issues due to EU process lagging• Process never been correctly implemented for cultivation EU Commission 2011 reports on the EU GMO legislative framework:

¨…the reports note that the authorisation system could be more efficient, GMO cultivation would benefit from more flexibility and the risk assessment process from further harmonisation…”

New and emerging areas where scientific support could accelerate innovation (III)

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The science re. contribution to productivity, competitiveness and economic growth is there

→ “…GM crops are already contributing to increased yields, greater ease and predictability of crop management, a reduction in pesticide use and fewer post-harvest crop losses…” (Tait and Barker in EMBO report 2011)

→ Several JRC reports and JRC peer-reviewed papers indicate positive economic impact for adopting farmers as well as welfare gains for other economic agents (e.g consumers).

→ In line with reports from FAO, IFPRI, American Research Council and hundreds of peer-reviewed papers.

Science-based→ Increased trans-disciplinary approach to R&D to break traditional silos

(e.g. in the development of personalised medicines, integration of actors in biorefineries)

→ Increased cooperation between academia and industry → Including regulators and end users in R&D projects would be beneficial→ Involvement of industry in publically-funded projects to increase uptake→ Appropriate infrastructures are needed to support R&D (e.g. biobanks,

registries, biomass storage and logistics chains, etc…)Non science-based→ Set up specific "EU Innovation Fund" also to aid transition of results to full

scale implementation and to marketplace→ Increase public funding for demonstration projects and stimulate the

construction of demonstrators via Public Private Partnerships→ Workable & predictable regulatory environment to get the products of

R&D and innovation on the market.

Obstacles to the translation of research into innovation and proposed solutions 1/2

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→ Access to funding at all stages including research, for all sectors including theemerging bio-based industries

→ Appropriate take up of and rewards for innovation (e.g. pricing and reimbursement for biopharmaceuticals)

→ Appropriate IP framework (e.g. EU patent)→ Increasing awareness and acceptance of new technologies by end users→ Simple, predictable and innovation-friendly policy and regulatory environment (e.g.

revision of the Clinical Trials Directive; Health Technology Assessment, Bioeconomy action plan, timely implementation of GM-legislation, elimination of the accumulation of yet-to-be-approved agbiotech products causing Europe and its farmers to lag behind the rest of the world)

An additional idea: Can EU science or EU research policy help solve domestic «regulatory» issues? In addition to funding EU research and carrying out in-house research on biosafety of e.g. GMOs, the Commission could… work further on the “challenge of feeding scientific advice into Policy-Making” . The JRC should play a key role in this!

Key elements to facilitate translation of R&D into innovative products

SUMMARY

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Thank you for your attention

Nathalie Moll, Secretary General, EuropaBio

www.europabio.org

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