Current Pharmacogenomics and Personalized Medicine, 2009, 7, 231-237 231 1875-6921/09 $55.00+.00 © 2009 Bentham Science Publishers Ltd. Feature Article Small is Beautiful: What Can Nanotechnology Do for Personalized Medicine? G.E. Marchant * Center for the Study of Law, Science & Technology, Arizona State University, AZ, USA Abstract: Nanotechnology and personalized medicine are two of the most rapidly emerging areas of biomedical research, as well as two of the most promising technologies for improving health care and health outcomes. They are also rapidly converging in numerous current and future clinical applications. Examples include the use of nanotechnology for im- proved DNA sequencing and SNP analysis, the development of nano-therapeutics that can target specific cell and tissue types, biosensors for specific proteins and other molecules in vivo, and point-of-care molecular diagnostic devices enabled by nanotechnology. Nanotechnology offers many advantages for personalized medicine applications, including a size that matches the scale of the molecular substrates of personalized medicine, an increased sensitivity in detecting and binding with target molecules, and flexibility in the design and function of therapeutics and diagnostics at the nano scale. Yet, at the same time, the utilization of nanotechnology in personalized medicine may create uncertainties or risk relating to po- tential toxicity. In addition to describing the scientific and technical opportunities and challenges in applying nanotech- nology to personalized medicine, this article also addresses some of the policy, legal and ethical issues raised by the con- vergence of nanotechnology and personalized medicine. Keywords: Medical Devices, Nanomedicine, Nanotechnology, Personalized Medicine, Pharmaceuticals. 1. INTRODUCTION Nanotechnology, the “science of the small”, is revolu- tionizing diverse areas of research, product development and manufacturing, and commerce. No area is more likely to be affected by and benefit from nanotechnology than medicine, and within the nascent but rapidly growing field of nanomedicine, personalized medicine applications are amongst the most promising and exciting innovations [1, 2]. Because personalized medicine often involves biomarkers or interactions at the macromolecular level, nanoscale technologies, products and processes are at the same general size scale and may be well-matched for various applications in personalized medicine. This review briefly describes nanotechnology, discusses some of the intersections of nanotechnology with personalized medicine, and concludes with a discussion of some of the scientific and policy im- pediments and barriers to the applications of nanotechnology to personalized medicine, including toxicity and regulatory concerns. 2. WHAT IS NANOTECHNOLOGY? Nanotechnology (derived from the Greek word “nano”, meaning dwarf) is the use and manipulation of materials roughly in the range of 1 to 100 nanometers (nm) that exhibit unique properties due to their size. By comparison, a DNA *Address correspondence to this author at the Sandra Day O’Connor College of Law, P.O. Box 877906, Tempe, AZ, USA 85287-7906, USA; Tel: 480-965-3246; Fax: 480-727-6973; E-mail: gary.marchant@asu.edu molecule is approximately 2 nm wide and most virus parti- cles range from 5 to 50 nm in diameter. At the nanoscale size, materials tend to exhibit unique properties not shared at the larger bulk sizes or the smaller molecular scale, due in part to the high proportion of atoms on a nanoparticle that are on the external surface of the structure, resulting in a more reactive agent [3]. A wide variety of scientific fields and industries are seeking to take advantage of these unique properties to provide novel functions, attributes and prod- ucts. To date, over 1000 consumer products are already on the market, including many medical products including pharma- ceuticals, diagnostics, devices, and implants [4]. The first generation of nanotechnology products involve relatively simple nanomaterials such as carbon nanotubes, buckeyballs, quantum dots, and nanoscale particles of chemicals such as silver, iron oxide or titanium dioxide. A second generation of nanotechnology products that involve more complex systems or devices are currently being developed. One of the most active applications of nanotechnology is “nanomedicine” or the medical application of nanotechnol- ogy, which includes the development of new nanotechnol- ogy-enabled therapeutics and diagnostics [5]. Several nanotechnology drugs and medical devices have already received regulatory approval, and many more products are currently being actively investigated in clinical trials [6]. As of 2006, when a comprehensive global survey of nanomedi- cine activity was published in the open literature, 38 nanotechnology-enabled products were on the market, with total sales over $6.8 billion [7]. These figures have no doubt