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European Biopharmaceutical Review
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Over the past 30 years, nanotechnology has shown great promise in advancing the fields of medicine, cosmetics, electronics, material sciences, information technology, energy production and engineering. During this time, public and private funding in the area of nanotechnology has increased to advance the science and commercialisation of nanotechnology-based products. For example, the US National Nanotechnology Initiative’s (NNI) 2010 budget is expected to reach $1.64 billion to support basic research, infrastructure development and technology transfer in the fields of healthcare, electronics, aeronautics, agriculture, food and energy. From this proposed budget, $326 million has been allocated to the National Institutes of Health (NIH) to conduct nanotechnologyrelated medical research (1). According to the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN), over 800 nanotechnology-based consumer products are currently on the market, with a total value of $147 billion (2). The analysis firm Lux Research predicts that nanotechnology products will reach a total value of $3.1 trillion by 2015. Similar trends are also predicted for nanotechnology-based drug products, whose total market value may reach $200 billion by 2015 (3). It is expected that nanotechnology-based products will continue to be developed as novel and effective therapies move from the bench to the clinic.
NANOTECHNOLOGY: TODAY
The concept of nanotechnology in targeted therapy was first introduced by Paul Ehrlich, the 1908 Nobel Laureate. Ehrlich conceived the notion of ‘magic bullets’: specific compounds that seek out the disease causing organism and destroy it without harming other parts of the body. This is the promise that today’s nanotechnology drug products offer for diagnosing, imaging and treating diseases. The US NNI defines nanotechnology as: “The understanding and control of matter at dimensions between approximately one and 100 nanometers where unique phenomena enable novel applications” (4). |
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Dr Nakissa Sadrieh obtained her doctorate in Toxicology in 1993 from Rutgers University in New Jersey. Following a postdoctoral fellowship in the Laboratory of Chemical Carcinogenesis at the National Cancer Institute, Nakissa joined the Food and Drug Administration (FDA) in 1996. She is currently the Associate Director for Research Policy and Implementation in the Office of Pharmaceutical Science within the Center for Drug Evaluation and Research (CDER). Her work is aimed at filling research needs to help address regulatory questions.
Dr Banu Zolnik is a pharmacologist in the Science and Research Staff of the Office of Pharmaceutical Science within CDER, FDA. Prior to joining the FDA in 2008, Banu worked as a postdoctoral fellow in the Nanotechnology Characterization Laboratory at the National Cancer Institute. Banu obtained her doctorate in Pharmaceutical Sciences from the University of Connecticut in 2005. She received her Bachelor of Science in Pharmacy from Istanbul University in Turkey in 1997. Her research interests are related to regulatory aspects of the development of novel dosage drug delivery systems, such as nanoparticles, microspheres, emulsions and liposomes. |
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