International Handbook on Regulating Nanotechnologies
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International Handbook on Regulating Nanotechnologies

Edited by Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard

As scientists and technologists discover how to engineer matter at the nanoscale in increasingly sophisticated ways, conventional approaches to ensuring safe use are being brought into question. Nanotechnologies are challenging traditional regulatory regimes; but they are also prompting new thinking on developing and using emerging technologies safely. In this Handbook, leading international authors from industry, government, non-governmental organisations and academia examine the complex and often controversial regulatory challenges presented by nanotechnologies. Across several disciplinary boundaries, they explore how the future regulatory landscape may evolve. From the Europe Union to the United States, workplaces to personal products, and statutory instruments through to softer approaches, it is clear that considerable vigilance will be needed in governing these powerful and novel technologies. To succeed, society will need new thinking, new partnerships and new mechanisms to balance the benefits of these technologies against their possible downsides. Anything less will prompt cries of illegitimacy and potentially compromise a promising new realm of technology innovation.
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Chapter 14: Therapeutic Products: Regulating Drugs and Medical Devices

Rogério Sá Gaspar


Rogério Sá Gaspar 14.1 TRENDS AND TENDENCIES IN DRUG DISCOVERY, PHARMA PIPELINES AND STRATEGIES The forward march of innovative technologies is changing the context for pharmaceutical development. Integration of diagnostics and therapeutic approaches is raising new possibilities in medical treatment, along with a number of innovative medicinal products for clinical use, including monoclonal antibodies (and their fragments), targeted chemical entities and new drug delivery systems including nanopharmaceuticals (liposomes, nanoparticles and macromolecular or polymer-conjugates) (Duncan, 2003a, 2003b; Duncan et al., 2006; Peer et al., 2007; Bawarski et al., 2008). Scientific integration between emerging technologies and the ability to benefit from converging sciences raises the possibility of bringing better medicines faster to the market and looking at improved ways to solve previously unmet clinical needs (European Science Foundation (ESF), 2005). At the same time, a wave of scientific optimism is facing obstacles arising from late developments in the organization and business models of the pharmaceutical industry. Difficulties arise from limited financial support aimed at savings in copayment systems (public or private) which increase the pressure for generic drugs. Additional pressure originates from the need for proof in adequately established pharmacoeconomics research studies looking at comparative therapeutic added value of new medicines and new health technologies (National Institute for Health and Clinical Excellence (NICE), 2002). In recent years major trends in drug discovery have looked at the complex networking of research organizational and strategic options. The classical approach, followed by major companies, which used in-house development of new pharmaceuticals (both active product...

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