Abstract

Nanomedicine aims to apply and further develop nanotechnology to solve problems in medicine, related to diagnosis, treatment and/or disease prevention at the cellular and molecular level (Feng, 2006; Feng and Chien, 2003). Nanomedicine by nature is interdisciplinary, with benefits being realised at the interface of science and engineering, physical science and engineering, chemical science and engineering, cellular and molecular biology, pharmacology and pharmaceutics, medical sciences and technology and combinations thereof. The difference in perspective between disciplines may be partly responsible for the lack of nomenclature or universally-accepted definition for various “nano” terms, which causes issues with respect to publication consistency, regulatory agencies, patent offices, industry and the business community (Rannard & Owen, 2009; Tinkle et al., 2014; Bawa, 2013; Bawa, 2016). Regulatory agencies such as the US Food and Drug Administration (FDA; http://www.fda.gov/) and European Medicine Agency (EMA; http://www.ema. europa.eu/ema/) have generally failed to employ an interdisciplinary approach to regulate nanoscale technologies in the samemanner as they apply to drugs because they do not fully appreciate the interdisciplinary nature or novel characteristics ofmany submissions that disclose nanomedicines (e.g., as a result of high-surface-area to-volume ratio, inherent reactivity due to a greater proportion of exposed surface atoms, unpredictable properties, or toxicity profiles as compared to bulk). Currently, these agencies instead rely upon established laws and regulations validated through experiencewith conventional small molecule medicines. Synthesis and characterization of molecular biomaterials forms the material basis for nanomedicines. Molecular biomaterials may include synthesized biocompatible polymers such as currently accepted biodegradable polymers including polylactic acid (PLA), polycaprolactone (PCL) and polylactic-co-glycolic acid (PLGA), or molecularly engineered macromolecules such as lipids, DNAs, RNAs, proteins and peptides. Such bio materials are either used to stabilise nanosized particles of drug or to form nano-carrier technologies for sustained, controlled or targeted release of diagnostic and therapeutic agents to enhance their biological effects and to reduce their side effects (Feng et al., 2007; Owen, 2014; Bawa, 2016). Similarly, patent offices also often fail to recognize that an interdisciplinary approach needs to be applied by patent examiners while reviewing nanotechnologybased patent applications, since the technologies reflected in these patent applications often involve a combination of disciplines. In fact, non-uniform or Andrew Owen Steve Rannard

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