Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars.

Nanomedicines are highly complex products and are the result of difficult to control manufacturing processes. Nonbiological complex drugs and their biological counterparts can comprise nanoparticles and therefore show nanomedicine characteristics. They consist of not fully known nonhomomolecular structures, and can therefore not be characterized by physicochemical means only. Also, intended copies of nanomedicines (follow-on similars) may have clinically meaningful differences, creating the regulatory challenge of how to grant a high degree of assurance for patients' benefit and safety. As an example, the current regulatory approach for marketing authorization of intended copies of nonbiological complex drugs appears inappropriate; also, a valid strategy incorporating the complexity of such systems is undefined. To demonstrate sufficient similarity and comparability, a stepwise quality, nonclinical and clinical approach is necessary to obtain market authorization for follow-on products as therapeutic alternatives, substitution and/or interchangeable products. To fill the regulatory gap, harmonized and science-based standards are needed.

Recent Advances in Nanotechnology-Based Diagnosis and Treatments of Diabetes.

Nanotechnology is a field encompassing nanostructures, nanomaterials and nanoparticles, which are of increasing importance to researchers and industrial players alike. Nanotechnology addresses the construction and consumption of substances and devices on the nanometer scale. Nanomedicine is a new field that combines nanotechnology with medicine to boost human health care. Nanomedicine is an interdisciplinary field that includes various areas of biology, chemistry, physics and engineering. The most important problems related to diabetes management, such as self-monitoring of blood glucose levels and insulin injections, can now be conquered due to progress in nanomedicine, which offers glucose nanosensors, the layer-by-layer technique, carbon nanotubes, quantum dots, oral insulins, microspheres, artificial pancreases and nanopumps. In this review, the key methodological and scientific characteristics of nanomedicine related to diabetes treatment, glucose monitoring and insulin administration are discussed.

Forming interdisciplinary expertise: one organization's journey on the road to translational nanomedicine.

This paper provides a sociological account of how researchers of different disciplines become experts in translational nanomedicine. Using a case study of the Nanotechnology Characterization Laboratory (NCL) at the National Cancer Institute (NCI), the author argues that the relationship between the different disciplines involved in translational nanomedicine should be understood in the broader sociopolitical context of the boundary politics between the academy, industry, and government. This study suggests that the process of training the nanobio expert is not simply a process of inculcating skills; it is also a process of institution building. In the case of the NCL, sustaining the laboratory's existence at the interface between the university, industry, and government informed how researchers practiced interdisciplinarity and cultivated their interdisciplinary expertise. It required mobilizing institutional resources through administrative/managerial strategies. Viewing the formation of a professional identity as a social process helps clarify the meaning of interdisciplinarity and provides insight in evaluating the performance of interdisciplinary collaboration and the design of nanoscience education.

BioForce Nanosciences, Inc.

BioForce Nanosciences, Inc. (BFNH.OB) develops and commercializes nanotechnology tools and applications for the life sciences. The company is based in Ames, Iowa, and has two divisions--instruments and applications. The instrument division includes the Nano eNabler system and associated consumables (SPT print cartridges and Sindex substrates) and a surface decontamination device known as the ProCleaner. The applications division develops Nano eNabler-based applications for a variety of purposes. The current application pipeline includes the patented ViriChip pathogen detection and identification system, the Chip-On-A-Tip ultraminiaturized cancer biomarker detection system and a proprietary method for high-throughput molecular interaction screening known as FAST. The unique capabilities of the Nano eNabler system allow the creation of novel applications that take advantage of vastly reduced spatial scales and sample volumes. Popular applications of the Nano eNabler system include: functionalizing biosensors, including micro-electromechanical systems/nano-electromechanical systems devices; patterning surfaces with molecules to study cell growth, behavior and differentiation; performing ultrasensitive bioassays; and printing arrays in confined spaces in microfluidic devices.

Launch of the London Centre for Nanotechnology.

Is nanomedicine an area with the promise that its proponents claim? Professors Gabriel Aeppli and Quentin Pankhurst explore the issues in light of the new London Centre for Nanotechnology (LCN)--a joint enterprise between Imperial College and University College London--opened on November 7, 2006. The center is a multidisciplinary research initiative that aims to bridge the physical, engineering and biomedical sciences. In this interview, Professor Gabriel Aeppli, LCN co-Director, and Deputy Director Professor Quentin Pankhurst discuss the advent and future role of the LCN with Nanomedicine's Morag Robertson. Professor Aeppli was formerly with NEC, Bell Laboratories and MIT and has more than 15 years' experience in the computer and telecommunications industry. Professor Pankhurst is a physicist with more than 20 years' experience of working with magnetic materials and nanoparticles, who now works closely with clinicians and medics on innovative healthcare applications. He also recently formed the new start-up company Endomagnetics Inc.

Cenamps: adding value to the North East region.

Cenamps' highly talented and commercially experienced team work closely with business leaders to stimulate and manage market-led innovation, enabling businesses to develop new products and services as well as strengthen the regional economic foundation, R&D capabilities and performance. Cenamps achieves this by establishing new state-of-the-art R&D facilities and applied research projects for developing new technologies that will yield significant societal, economic and commercial benefits.

Zyvex Corporation.

Founded in 1997, Zyvex is the first molecular nanotechnology company. The company's vision is to become the worldwide supplier of tools, products and services that enable adaptable, affordable and molecularly precise manufacturing. Zyvex technology is being used in biomaterials and subcellular characterization, nanomaterial composites for biomedical implants and 3D microsystems for miniature instrumentation. Nanotechnology is pervasive within biological systems, from membranes (tens of nanometers thick) that facilitate molecular trafficking into and within cells, to proteins (just a few nanometers in size) that perform most structural and functional duties of living organisms. It therefore stands to reason that tools to enable exploration and characterization of biological nanosystems and materials to enhance and repair these systems will be required to realize the full potential of nanomedicine.

Medical nanotechnology in the UK: a perspective from the London Centre for Nanotechnology.

Nanotechnology research is booming worldwide, and the general belief is that medical and biological applications will form the greatest sector of expansion over the next decade, driven by an attempt to bring radical solutions to areas of unmet medical need. What is true in the United States is also being fulfilled in Europe. This, though, is generally at a significantly lower investment level, even if for "large" capital infrastructure and interdisciplinary centers. Against this, the United Kingdom and its European partners are following the maxim "small is beautiful" and are attempting to identify and develop academic research and commercial businesses in areas that traditional nanotechnology developments involving engineering or physics find challenging. Thus in London-University College London (UCL) in a major joint project with Imperial College and linked to other UK and European centers of excellence-we are building upon our internationally competitive medical research (the two universities together form one of the largest centers of biomedical research outside the United States) to focus on and develop medical nanotechnology as a major sector of our research activity. A novel approach to commercialization has been the establishment with government and private equity funds of a "BioNanotechnology Centre" that will act as a portal for UK industry to access specialist skills to solve issues relating to developing nanotechnology-based medical applications, for example, for environmental screening, diagnostics, and therapy. This article reviews our academic and business strategy with examples from our current biomedical research portfolio.