Challenges to Nanomedicine

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Medicine is one of the fastest-growing areas of application of nanotechnology and the use of nanomaterials, nanoscale manipulation and engineering is already having an impact across almost all medical product sectors and medical specialisms. While the pipeline of products implementing nanotechnology in some form is already significant with many times more at an earlier stage of research and development, it is useful to review those steps a potential nanomedical product will have to go through before it reaches the stage of commercial exploitation or clinical availability. Considerable efforts have been made to harmonise medical product regulatory systems globally but many differences between countries still remain in areas such as health technology assessment or reimbursement. Likewise, public perceptions of emerging technologies can vary from society to society. It is important therefore for researchers and manufacturers to understand all of these challenges at an early stage of product development and to accumulate the data required for these various procedures in a timely manner so as not to face delays in placing nanomedical products onto the market or in seeking their uptake within healthcare systems.

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With the booming development of bionanotechnology, a variety of multifunctional nanoparticle platforms have been explored to facilitate drug delivery in cancer treatment. Thanks to their good biocompatibility and versatile structures, the lipid-based nanoparticles can serve as ideal candidates to carry therapeutic reagents to cancer tissues. Additionally, the natural polymeric coating of liposomes could easily fuse with cellular membrane and minimize clearance by blood circulation. To date, their composition, properties, targeting strategies, reasonable design methods, and pharmacokinetics have been extensively studied to facilitate preclinical and clinical translations. In this chapter, we will introduce the structure and function of the lipid-based nanoparticle system, and a comprehensive review of the lipid-based nanoparticle drug delivery system will be presented.
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Medicine in the 21(st) century is increasingly dependent on technology. Unlike in many other areas, the cost of medical technology is not declining and its increasing use contributes to the spiraling healthcare costs. Many medical professionals equate progress in medicine to increasing use of sophisticated technology that is often expensive and beyond the reach of the average citizen. Pediatric heart care is very technology-intensive and therefore very expensive and beyond the reach of the vast majority of children in the developing world. There is an urgent need to address this situation through development and use of appropriate technology in accordance with the needs and priorities of the society. A number of simple and inexpensive quality measures that have the potential of improving outcomes substantially without the need for expensive equipment should be instituted before embracing high-end technology. Innovations to reduce costs that are commonly used in limited resource environments should be tested systematically.
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Ever-increasing health care costs undermine expansions in health insurance coverage. Debate about lowering unit costs tends to focus on reducing payment levels for existing products and providers, but such measures are not likely to succeed, given established overhead costs and income expectations. Instead, moderation in health care spending must be sought in new products and processes that use lower-cost materials, staff, equipment, and sites of care. We give examples and sketch the principal regulatory, payment, insurance, and policy design obstacles to the further development and diffusion of cost-reducing innovations.
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Treatment of large defects requires the harvest of fresh living bone from the iliac crest. Harvest of this limited supply of bone is accompanied by extreme pain and morbidity. This has prompted the exploration of other alternatives to generate new bone using traditional principles of tissue engineering, wherein harvested cells are combined with porous scaffolds and stimulated with exogenous mitogens and morphogens in vitro and/or in vivo. We now show that large volumes of bone can be engineered in a predictable manner, without the need for cell transplantation and growth factor administration. The crux of the approach lies in the deliberate creation and manipulation of an artificial space (bioreactor) between the tibia and the periosteum, a mesenchymal layer rich in pluripotent cells, in such a way that the body's healing mechanism is leveraged in the engineering of neotissue. Using the “in vivo bioreactor” in New Zealand White rabbits, we have engineered bone that is biomechanically identical to native bone. The neobone formation followed predominantly an intramembraneous path, with woven bone matrix subsequently maturing into fully mineralized compact bone exhibiting all of the histological markers and mechanical properties of native bone. We harvested the bone after 6 weeks and transplanted it into contralateral tibial defects, resulting in complete integration after 6 weeks with no apparent morbidity at the donor site. Furthermore, in a proof-of-principle study, we have shown that by inhibiting angiogenesis and promoting a more hypoxic environment within the “in vivo bioreactor space,” cartilage formation can be exclusively promoted. • cartilage • tissue engineering • hard tissue • vascularized organs
Individual inorganic nanoparticles (NPs) have been widely used in the fields of drug delivery, cancer imaging and therapy. There are still many hurdles that limit the performance of individual NPs for these applications. The utilization of highly ordered NP ensembles opens a door to resolve these problems, as a result of their new or advanced collective properties. The assembled NPs show several advantages over individual NP-based systems, such as improved cell internalization and tumor targeting, enhanced multimodality imaging capability, superior combination therapy arising from synergistic effects, possible complete clearance from the whole body by degradation of assemblies into original small NP building blocks, and so on. In this review, we discuss the potential of utilizing assembled NP ensembles for cancer imaging and treatment by taking plasmonic vesicular assemblies of Au NPs as an example. We first summarize the recent developments in the self-assembly of plasmonic vesicular structures of NPs from amphiphilic polymer-tethered NP building blocks. We further review the utilization of plasmonic vesicles of NPs for cancer imaging (e.g. multi-photon induced luminescence, photothermal, and photoacoustic imaging), and cancer therapy (e.g., photothermal therapy, and chemotherapy). Finally, we outline current challenges and our perspectives along this line.
Nanotheranostics is to apply and further develop nanomedicine strategies for advanced theranostics. This review summarizes the various nanocarriers developed so far in the literature for nanotheranostics, which include polymer conjugations, dendrimers, micelles, liposomes, metal and inorganic nanoparticles, carbon nanotubes, and nanoparticles of biodegradable polymers for sustained, controlled and targeted co-delivery of diagnostic and therapeutic agents for better theranostic effects with fewer side effects. The theranostic nanomedicine can achieve systemic circulation, evade host defenses and deliver the drug and diagnostic agents at the targeted site to diagnose and treat the disease at cellular and molecular level. The therapeutic and diagnostic agents are formulated in nanomedicine as a single theranostic platform, which can then be further conjugated to biological ligand for targeting. Nanotheranostics can also promote stimuli-responsive release, synergetic and combinatory therapy, siRNA co-delivery, multimodality therapies, oral delivery, delivery across the blood-brain barrier as well as escape from intracellular autophagy. The fruition of nanotheranostics will be able to provide personalized therapy with bright prognosis, which makes even the fatal diseases curable or at least treatable at the earliest stage.
Theranostics is a concept of integrating imaging and therapy into a single platform for use in the next generation of personalized medicine to meet the challenges in modern health care. The diagnostic role of theranostic agents reports the presence of a disease, its status, and its response to a specific treatment, while the therapeutic role of the agent can be implemented in several forms. Two-photon-excitation or second harmonic generation contrast agents, which utilize longer wavelength light, have been recently developed to overcome these limitations for imaging of cells and small animals. However, they require expensive ultrashort pulsed lasers to perform the excitation as they involve inefficient nonlinear optical processes. For bioimaging, some of the advantages are virtually zero autofluorescence background to improve signal-to-noise ratio, large anti-Stokes shifts allowing us to easily separate the PL from the excitation wavelength, narrow emission bandwidths allowing ease of multiplexed imaging.
Anonymity Compromised The balance between maintaining individual privacy and sharing genomic information for research purposes has been a topic of considerable controversy. Gymrek et al. (p. 321 ; see the Policy Forum by Rodriguez et al. ) demonstrate that the anonymity of participants (and their families) can be compromised by analyzing Y-chromosome sequences from public genetic genealogy Web sites that contain (sometimes distant) relatives with the same surname. Short tandem repeats (STRs) on the Y chromosome of a target individual (whose sequence was freely available and identified in GenBank) were compared with information in public genealogy Web sites to determine the shortest time to the most recent common ancestor and find the most likely surname, which, when combined with age and state of residency identified the individual. When STRs from 911 individuals were used as the starting points, the analysis projected a success rate of 12% within the U.S. male population with Caucasian ancestry. Further analysis of detailed pedigrees from one collection revealed that families of individuals whose genomes are in public repositories could be identified with high probability.
Unlabelled: Peripheral nerve injury still remains a refractory challenge for both clinical and basic researchers. A novel nanofiber conduit made of blood vessel and filled with amphiphilic hydrogel of self-assembling nanofiber scaffold (SAPNS) was implanted to repair a 10 mm nerve gap after sciatic nerve transection. Empty blood vessel conduit was implanted serving as control. Results showed that this novel nanofiber conduit enabled the peripheral axons to regenerate across and beyond the 10 mm gap. Motoneuron protection, axonal regeneration and remyelination were significantly enhanced with SAPNS scaffold treatments. The target reinnervation and functional recovery induced by the regenerative nerve conduit suggest that SAPNS-based conduit is highly promising application in the treatment of peripheral nerve defect. From the clinical editor: In this paper by Zhan et al, a novel self-assembling nanofiber scaffold is reported to promote regeneration of peripheral nerves in a sciatic nerve injury model. The promising results and the obvious medical need raises hope for a clinical translation of this approach hopefully in the near future.
Analyzes how successful firms fail when confronted with technological and market changes, prescribing a list of rules for firms to follow as a solution. Precisely because of their adherence to good management principles, innovative, well-managed firms fail at the emergence of disruptive technologies - that is, innovations that disrupt the existing dominant technologies in the market. Unfortunately, it usually does not make sense to invest in disruptive technologies until after they have taken over the market. Thus, instead of exercising what are typically good managerial decisions, at the introduction of technical or market change it is very often the case that managers must make counterintuitive decisions not to listen to customers, to invest in lower-performance products that produce lower margins, and to pursue small markets. From analysis of the disk drive industry, a set of rules is devised - the principles of disruptive innovation - for managers to measure when traditional good management principles should be followed or rejected. According to the principles of disruptive innovation, a manager should plan to fail early, often, and inexpensively, developing disruptive technologies in small organizations operating within a niche market and with a relevant customer base. A case study in the electric-powered vehicles market illustrates how a manager can overcome the challenges of disruptive technologies using these principles of disruptive innovation. The mechanical excavator industry in the mid-twentieth century is also described, as an example in which most companies failed because they were unwilling to forego cable excavator technology for hydraulics machines. While there is no "right answer" or formula to use when reacting to unpredictable technological change, managers will be able to adapt as long as they realize that "good" managerial practices are only situationally appropriate. Though disruptive technologies are inherently high-risk, the more a firm invests in them, the more it learns about the emerging market and the changing needs of consumers, so that incremental advances may lead to industry-changing leaps. (CJC)
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