Opportunities & Risks in Nanomedicine the next Generation of Health Care
5o ENIFarMed Sao Paolo, 29th – 31st August 2011 Opportunities & Risks in Nanomedicine - How to build an Infrastructure in Support of the next Generation of Health Care 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnology Industries Association (NIA) … the sector-independent, responsible voice for the industrial nanotechnologies supply chains; … it proactively supports the ongoing innovation and commercialisation of the next generation of technologies and promotes their safe and reliable advancement. 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) nano micro Nanotechnology – Why now? atomic Biology 1950 2000 2050 Invention of the Scanning Tunneling Electron Microscope 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) micro Nanotechnology – Why now? Most significant development [in health care]: nano • Nano-scale characterization tools atomic Biology 1950 2000 2050 Invention of the Scanning Tunneling Electron Microscope 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnology – Innovation in Healthcare Healthcare = Pharmaceuticals + Medical Devices + Consumer Products nanotech - enabled Miniturisation devices, analytical techniques, biosensors molecular and supramolecular systems nanotech - enabled current ‘conventional’ healthcare Complex molecular assemblies [Source: NanoMedicine – European Science Foundation – European Medical Research Council Forward Look report, 2004] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnology – Innovation in Healthcare Healthcare = Pharmaceuticals + Medical Devices + Consumer Products nanotech - enabled Miniturisation based on / delivering molecular and supramolecular systems improved ‘21st century’ healthcare nanotech - enabled devices, analytical techniques, biosensors Complex molecular assemblies [Source: NanoMedicine – European Science Foundation – European Medical Research Council Forward Look report, 2004] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnology – Innovation in Healthcare Where is Innovation happening? (excerpts of) global research funding for nanomedicine: one of NIH (US) top 5 priority areas NCI (National Cancer Institute, US) committed US$ 140 million in 2004 Germany invested € 50 million in bionanotechnology ~50% of venture capital funding for nanotechnology goes to life-science start-ups EC: increased R&D funding of nanomedicine from € 330 million (FP6 (2002-2006)) to ~ € 280 million (first 2 years FP7 (i.e. 2007-2009)) 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnology – Innovation in Healthcare Current and planned nanomedicine products by industry (2010) Established nanoproducts Recent market launch Prototype stage Concept stage - nanoparticles as - nanostructured - biocompatible - artificial organs contrast media hydroxylapatitie as bone substitute - nanoscale drug carriers - selective drug - quantum-dot - nanomembranes for dialysis implants carriers markers - nanoprobes and - nano cancer therapy nanomarkers for through tissue engineering - nanoengineered gels for supporting nerve cell growth molecular imaging - neuro-coupled electronics for active implants [Source: European Competitiveness in Key Enabling Technologies, European Commission (ZEW, TNO)] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnologies in Healthcare ... something to be proud of: [Inventory of nanotechnology-based consumer products, Woodrow Wilson Center, Project on Emerging Nanotechnologies.] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnologies – Whose Business is it anyway? Where is Innovation happening? 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnologies – Who’s making money? Number of Companies Nanotechnology-related Sales Share the big ones Share in total Sales of the Company [source: Malanowski et al, Growth Market Nanotechnology, Wiley-VCH, Weinheim 2006] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnologies – Who’s making money? Number of Companies Nanotechnology-related Sales Share Share in total Sales of the Company the small ones [source: Malanowski et al, Growth Market Nanotechnology, Wiley-VCH, Weinheim 2006] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) (Nano)Medicine – The Way in is the Way out Pharmaceutical development and timelines [Source: Patent Protection Strategies: Maximinsing Market Exclusivity – Reuters Report] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanomedicine – Brazil’s Position Average annual growth rates of nanotechnology-related and all publications by country, 1996-2006 [Nanotechnology: An Overview based on Indicators & Statistics; OECD STI Working Paper 2009/7, June 2009] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanomedicine – Brazil’s Position Average annual growth rates of nanotechnology and all patents by country, 1995-2004 [Nanotechnology: An Overview based on Indicators & Statistics; OECD STI Working Paper 2009/7, June 2009] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanomedicine – old Industry versus Innovation Revealed Technological Advantages (RTA )Index: (1) Specialisation across nanotechnology application fields (until 2005) Note: RTA indexes over 1 indicate a higher relative specialisation. [Nanotechnology: An Overview based on Indicators & Statistics; OECD STI Working Paper 2009/7, June 2009] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanomedicine – old Industry versus Innovation Revealed Technological Advantages (RTA )Index: (1) Specialisation across nanotechnology application fields (until 2005) Note: RTA indexes over 1 indicate a higher relative specialisation. Enhanced ‘specialisation’ of patenting in BRIC pharma- and biotechnology-innovations enabled by nanotechnology [Nanotechnology: An Overview based on Indicators & Statistics; OECD STI Working Paper 2009/7, June 2009] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nano2Market - Towards Good Practice for IPR & Technology Transfer in Nanotechnology Development 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Excerpt: Market Developments Case-Studies of nanotechnology-enabled innovations: • • • • • • • • Energy production and storage Fuel Cells Energy production and storage Ultracapacitors - Batteries Energy production and storage Organic photovoltaic CNT for actuators CNT for structural materials Nanoparticles for drug delivery Biosensors for diagnostics Biosample characterisation tools (SPM, NSOM) 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Excerpt: Market Developments Case-Study: Nanoparticles for Drug Delivery Nano2Market Technology Map: 1. Search strategy, composed of combinations of key-words World Publications Patents 2. Innovative data-mining techniques applied to combine the technology map with a view to identify underlying clustering 3. Detailed patent analysis 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nano2Market – The Results Case-Study Results: TT, scale-up and prototyping is seen as a nano-specific problem in the area of nanotechnology exploitation problems in finding competent consultants Regulatory uncertainties are hampering: Funding Entries Exists Best Practice Advice: Niche Opportunity: nano-skilled IP- and TT-Personnel Policy Makers: consider organising research centres according to application areas Academia: In case of visible value-chain: patent & license to large industry (cf. pharma) In case of invisible value-chains (i.e. Bion-Nano-ICT): collaborate with / license to other research facility 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nano2Market – The Results … to find out more: The ‘Nano2Market’ -Toolbox: 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nanotechnology – Innovation-Chain Issues Nano-specific ‘problems’ in a typical technology innovation chain: TT IP Proof of Concept Commercialisation & Market Uptake Demonstration & Scale-Up Research & Development Basic Research & Discovery Safety Approval Market Identification Patent Scale-up, Pilot Plant Prototype Approval, Registration Market Governments / Regulators R&D- & Innovation Support, IP-Protection Policies, Exploitation Policies/Support nano-specific OHSPolicies/Regulation nano-specific EHSPolicies/Regulation Global policy-informing -& -making Community OECD Working Party on Nanotechnology (OECD WPN) Standardisation (ISO, CEN, BSI, DIN, etc.) • Certified Reference Materials • Metrology Standards OECD Working party on Manufacture Nanomaterials (OECD WPMN) • nano-adapted OECD Test Guidelines (OECD TGs) • • Mutual Acceptance of Data OECD Harmonised Templates (OECD HTs) Industry R&D Support Advocacy Public-Private-Partnerships Networks IP- & TT-Studies 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) NIA Activities – Globally proactive Projects 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) NIA Activities – Public-Private-Partnerships Past & Present: Safety Assessment & Regulatory Review : * 50:50 public-private-partnership with the UK Government to support the OECD Sponsorship Programme on Manufactured Nanomaterials: £3.7 Million for in-depth characterisation, ecotoxicology testing and detection prototyping of nano-ZnO and nano-CeO2: PROSPECT – ‘Ecotoxicology Test Protocols for Representative Nanomaterials in Support of the OECD Sponsorship Programme’ (January 2009 – December 2011) Present: Safety Assessment & Regulatory Review: * Industry-funded contribution to the OECD Sponsorship Programme on Manufactured Nanomaterials: EURO 245 000 for in-depth characterisation and ecotoxicology testing of nano-Clay: RefNanoCLAYM – ‘Lead-Sponsorship, Characterisation and Testing of Reference NanoClay Materials within the OECD Sponsorship Programme’ (September 2010 – September 2011) Future: Safety Assessment & Regulatory Review: * Global 50:50 public-private-partnership with the European Commission, German Govmt, French Govmt (...) in support and advancement of the OECD Sponsorship Programme on Manufactured Nanomaterials: (current DRAFT: EURO 4.7 Million) for a Global-NanoMaPPP – ‘Global PPP for the Integrated Measurement and Testing of Reference NanoMaterials’ (July 2011 – December 2012) [* NIA-initiated and led] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) NIA Activities - OECD WPMN Sponsorship Programme For more information, visit: www.nanotechia-prospect.org 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) NIA Activities - OECD WPMN Sponsorship Programme PROSPECT Publications • Cerium Oxide Literature Review • Zinc Oxide Literature Review • Protocol for Nanoparticle Dispersion • Guidelines and Protocol for Sampling • Evaluation and Assignment of Nanoparticle Dispersion/Characterisation Methodologies, to be developed under PROSPECT • Video: Dispersion Protocol For more information, visit: www.nanotechia-prospect.org 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) NIA Activities – Global Results – available Data Reference NanoMaterial Series (European Commission, JRC): [Image courtesy JRC, European Commission] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) NIA Activities – Global Results – available Data NANOhub: online database in support of globally harmonised (adapted - if necessary) tests and measurements of Representative Manufactured Nanomaterials, based on OECD Test Guidelines, capturing data in IUCLID-format, based on OECD Harmonised Templates (OHTs) under Mutual Acceptance of Data (MAD). 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) NIA Activities – Global Results – available Data 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Nano(Medicine) – The Future (Pharma-)Industry Lessons from the GMO Debate: Conflict of interest Company (self)-serving products Regulatory disarray Nanotechnology – a test for industries’ ability to manage new science "Wherever this field leads, it is likely to follow the well-known pathway of incredible results leading to unrealistic expectations followed by sobering complications and disappointments and ultimately, cautious optimism." [Drs Roger Latham and Peter Oettgen, Harvard Medical School] 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011) Contact: Dr Steffi Friedrichs Director General Nanotechnology Industries Association t: +32 2300 5933 f: +32 2300 5938 m: +32 493 158 959 e: steffi.friedrichs@nanotechia.org w: www.nanotechia.org Brussels - NEW: Nanotechnology Industries Association (aisbl) 101 Avenue Louise 1050 Brussels Belgium London - NEW: Nanotechnology Industries Association (ltd) Lion House Red Lion Street London, WC1R 4GB United Kingdom Thank you! 5o ENIFarMed Sao Paolo, 29th – 31st August 2011 © Nanotechnology Industries Association (2011)
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