BIOE 402. Medical Technology Assessment. 2 or 3 hours. Bioentrepreneur course. Assessment of medical technology in the context of commercialization. Objectives, competition, market share, funding, pricing, manufacturing, growth, and intellectual property; many issues unique to biomedical products. Course Information: 2 undergraduate hours. 3 graduate hours. Prerequisite(s): Junior standing or above and consent of the instructor.

“Bioinformatics” 특집을 내면서

羟氨苄青霉素引起大疱性类天疱疮样疹

Applications of nanotechnology for treatment, diagnosis, monitoring, and control of biological systems has recently been referred to as "nanomedicine" by the National Institutes of Health. Research into the rational delivery and targeting of pharmaceutical, therapeutic, and diagnostic agents is at the forefront of projects in nanomedicine. These involve the identification of precise targets (cells and receptors) related to specific clinical conditions and choice of the appropriate nanocarriers to achieve the required responses while minimizing the side effects. Mononuclear phagocytes, dendritic cells, endothelial cells, and cancers (tumor cells, as well as tumor neovasculature) are key targets. Today, nanotechnology and nanoscience approaches to particle design and formulation are beginning to expand the market for many drugs and are forming the basis for a highly profitable niche within the industry, but some predicted benefits are hyped. This article will highlight rational approaches in design and surface engineering of nanoscale vehicles and entities for site-specific drug delivery and medical imaging after parenteral administration. Potential pitfalls or side effects associated with nanoparticles are also discussed.

https://www.cpe.vt.edu/globaltechseminars/downloads/nanomedicine_applications.pdf

Nanomedicine: current status and future prospects

Guidelines and Expert Consensus documents aim to present management and recommendations based on all of the relevant evidence on a particular subject in order to help physicians to select the best possible management strategies for the individual patient, suffering from a specific condition, taking into account not only the impact on outcome, but also the risk benefit ratio of a particular diagnostic or therapeutic procedure. The ESC recommendations for guidelines production can be found on the ESC website†.

In brief, the ESC appoints experts in the field to carry out a comprehensive and critical evaluation of the use of diagnostic and therapeutic procedures and to assess the risk–benefit ratio of the therapies recommended for management and/or prevention of a given condition. The strength of evidence for or against particular procedures or treatments is weighed according to predefined scales for grading recommendations and levels of evidence, as outlined below. Once the document has been finalized and approved by all the experts involved in the Task Force, it is submitted to outside specialists for review. If necessary, the document is revised once more to be finally approved by the Committee for Practice Guidelines and selected members of the Board of the ESC.

The ESC Committee for Practice Guidelines ( CPG ) supervises and coordinates the preparation of new Guidelines and Expert Consensus Documents produced by Task Forces, expert groups, or consensus panels. The chosen experts in these writing panels are asked to provide disclosure statements of all relationships they may have, which might be perceived as real or potential conflicts of interest. These disclosure forms are kept on file at the European Heart House, headquarters of the ESC. The Committee is also responsible for the endorsement of these Guidelines and Expert Consensus Documents or statements.

 
| Classes of recommendations |
|:-------------------------- | ------------------------------------------------------------------------------------------------------------------------ |
| Class I | Evidence and/or general agreement that a given diagnostic procedure/treatment is beneficial, useful, and effective |
| Class II | Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the treatment or procedure |
|  Class IIa | Weight of evidence/opinion is in favour of usefulness/efficacy |
|  Class IIb | Usefulness/efficacy is less well established by evidence/opinion |
| Class III | Evidence or general agreement that the treatment or procedure is not useful/effective and, in some cases, may be harmful |

Diabetes and cardiovascular diseases (CVD) often appear …

/pdf/guidelines-on-diabetes-pre-diabetes-and-cardiovascular-4j63bs7fb2.pdf

Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD).

https://www.cell.com/cell/pdf/S0092-8674(13)01546-8.pdf

What We Talk About When We Talk About Fat

The history of pneumatic biocompression in lymphedema has been fraught with controversy. Despite some evidence of benefit in animal models of disease, as well as in the clinical setting, the utilization of biocompression devices in lymphedema is far from universally embraced. It is clear that the acquisition of additional, objective data is warranted. Two articles in the current issue of Lymphatic Research and Biology strive to address this need. Working in a rat model, Huff and colleagues have attempted to objectively investigate the mechanisms whereby lymphatic pump techniques purportedly enhance lymphatic and immune function. The implications of their observations are that the pneumatic technique may enhance immune surveillance by increasing the numbers of lymphocytes released into the lymphatic circulation, in particular from the gut-associated lymphoid tissue. Clearly, this is an important, beneficial contribution of therapeutic intervention, assuming that analogous mechanisms operate in the human clinical context. In a parallel, clinical contribution, Ridner and colleagues have investigated the utility of advanced pneumatic therapy in the self care of truncal chronic lymphedema. Acknowledging that the impact of arm lymphedema has been a subject of relatively focused attention, the authors underscore the lack of attention that has heretofore been directed to the problem of truncal edema, which occurs not uncommonly in the breast cancer-surviving population. The authors have chosen to investigate the impact of self-administered use of an advanced pneumatic compression device upon the outcomes in this patient population. While the symptomatic responses were salutary, in this non-randomized control group, statistical significance in reduction of truncal girth was not achieved. As asserted by the authors of the investigation, it is clear that future studies should be undertaken to include larger patient cohorts, with a design that will also control for placebo effect. Nevertheless, the subject responses within this study represent a salutary finding and suggest that this, as well as many other subjects within the realm of pneumatic compression therapy, will warrant future attention.

Accruing Evidence for a Beneficial Role of Pneumatic Biocompression in Lymphedema

Lymphangiogenesis: Recapitulation of Angiogensis in Health and Disease

https://www.gastrojournal.org/article/S0016-5085(10)63005-3/pdf

W1108 Meta-Analysis of Interaction Between Clopidogrel and Proton Pump Inhibitor Therapy

Literature watch. Cooke CJ, Nanjee MN, Stepanova IP, Olszewski WL, Miller NE. Variations in lipid and apolipoprotein concentrations in human leg lymph: effects of posture and physical exercise. Atherosclerosis 2004; 173:39-45.

It is only recently that scientists and clinicians have begun to awaken to the concept that, among adult humans, there is a non-homogeneous expression of the altered function that characterizes both ‘‘normal’’ and ‘‘diseased’’ individuals. Most prominently, this transition has given rise to the phenomenon of gender studies in a variety of disease states and in manifestations related to human health. In our discipline of lymphatic biology and medicine, we have long been aware of gender influences upon the expression of both primary and secondary lymphedema. Similarly, there is now a small but growing awareness of the biology of aging in health and disease. Without question, the biology of aging represents the raison d’être for the National Institute on Aging, which supports prospective investigation of these phenomena in a variety of disease settings. To date, there has been little awareness of the role of aging in the function of the lymphatic circulation. However, in the current issue, Thangaswamy et al. have directed their attention to a specific manifestation of this phenomenology. Previously, it has been recognized that aging is associated with a decline in the contractility of the mesenteric vessels in rats, although the contributory mechanisms were largely not elucidated. With the current investigation, they found that in the mesenteric lymphatic vessels of aged rodent subjects, there was evidence of increased levels of cellular superoxide and mitochondrial reactive oxygen species, thus delineating the presence of both an increase in oxidative stress and a decrease in antioxidant activity. The implication of these findings is that oxygen-derived radicals may contribute to the previously observed, age-dependent decline in lymphatic pump function. Clearly, if these mechanisms can be extrapolated to other species and to both visceral and non-visceral lymphatic vasculature, it will have distinct future implications for our understanding of aging-related disease expression and to the application of effective therapeutics.

Stanley G. Rockson

Papers

Accruing Evidence for a Beneficial Role of Pneumatic Biocompression in Lymphedema

Lymphangiogenesis: Recapitulation of Angiogensis in Health and Disease

W1108 Meta-Analysis of Interaction Between Clopidogrel and Proton Pump Inhibitor Therapy

Literature watch. Cooke CJ, Nanjee MN, Stepanova IP, Olszewski WL, Miller NE. Variations in lipid and apolipoprotein concentrations in human leg lymph: effects of posture and physical exercise. Atherosclerosis 2004; 173:39-45.

The Lymphatic Biology of Aging