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London, United Kingdom

Preston J.R.,U.S. Army | Ferguson S.W.,EMA
40th European Rotorcraft Forum 2014 | Year: 2014

Wind or "rotorwash" generated by rotors, ducts, or jets affects the operational suitability and utility of future Vertical Take-Off and Landing (VTOL) aircraft. This paper presents the assessment process, environmental limits, rotorwash modeling, and output display supporting the rotorwash operational footprint model. These elements graphically combine to display the rotorwash operational impact assessment on the ground environment as contour plots or "footprints." The tools and methodology developed were for the single main rotor helicopter, tandem helicopter, and tiltrotor configurations, but can be extended to encompass additional configurations. The rotorwash operational footprint displays the effect of winds generated by rotor thrust on the surrounding environment. These footprints can be used to evaluate compliance with aircraft performance specifications, verify safe separation distances, or influence trade studies. Future military VTOL aircraft must have a rotorwash footprint that enables mission requirements to be safely accomplished. The influences of these key factors for safe operation are captured as a suggested performance specification for future military VTOL aircraft. Source

News Article
Site: http://phys.org/biology-news/

Made by KIT: The microfluidic bioreactor technically reproduces plant tissue. The researchers now start a new project to make the next step. Credit: KIT Plants produce a number of substances that can be used to treat cancer, Alzheimer's or Parkinson's disease. Frequently, however, metabolic pathways to obtain the target substance are so complex that its biotechnological production is hardly effective and very expensive. Scientists of KIT now combine their expertise with the technical know-how of Phyton Biotech GmbH, the biggest producer of pharmaceutical ingredients with plant cells. With the help of a microfluidic bioreactor consisting of coupled modules, the scientists technically reproduce complex plant tissue to produce active substances against cancer or Alzheimer's disease more effectively and at lower costs. According to latest estimates, plants form about a million chemical substances, so-called secondary metabolites. Unlike amino acids or sugar, these secondary metabolites are not of vital importance. However, this vast pool of plant products contains a true treasure of pharmaceutically active substances that inhibit the growth of cancer cells or reduce the formation of Alzheimer-typical plaques in the brain. Many of these valuable ingredients cannot be produced synthetically. Often, they have to be extracted directly from wild plants and processed at high costs. Moreover, many of these plants are rare and endangered: For instance, the discovery of Taxol inhibiting cancer cells brought the Pacific yew to the brink of extermination. "For this reason, biotechnological approaches to producing the respective active substances are of high interest," Peter Nick, Professor for Molecular Cell Biology of KIT's Botanical Institute, says. Often, underlying metabolic pathways are highly complex. In the natural plant, the substance of interest mostly is the product of a long chain of steps with many converted interim products. The chemical processes required for this purpose do not necessarily take place in a single plant cell, but in several specialized cell types found in the plant tissue from the root to the leaf. Many years ago, Phyton demonstrated that plant-based medical substances, such as Taxol, can also be produced with minimum resources and sustainably by the cultivation of plant cells in the lab. "Certain substances, however, can be produced neither in a simple cell culture nor in microorganisms manipulated by genetic engineering, because metabolic pathways are too complex," Peter Nick says. "Within the framework of a new research project, we now want to technically reproduce plant tissue with various cell types using a so-called microfluidic bioreactor. It consists of several modules, in which one cell type each is cultivated. The modules are connected via channels. Metabolic products of one cell type then enter the next module for further processing without the different cell types being mixed. In the end, the target substance can be extracted from the flow and, hence, "harvested". The project is managed by the Jülich Project Management Agency (PtJ) and funded with EUR 750,000 by the Federal Ministry of Education and Research for a period of two years. The project partners are the Botanical Institute and the Institute of Microstructure Technology (both of KIT) and the company Phyton Biotech GmbH. Together, the three partners possess the expertise required for the project. The Botanical Institute contributes its knowledge of molecular cellular biology of plant cell cultures. Professor Andreas Guber and Dr. Ralf Ahrens of the Institute of Microstructure Technology are responsible for the development and fabrication of partial components of microfluidic bioreactors, their microassembly, and interconnection to a functioning system. The industry partner Phyton Biotech GmbH is a worldwide leading company in the area of plant cell fermentation and supplies the expertise and infrastructure needed to analyze potential applications on the industrial scale. "Cooperation with the experts of KIT will allow us to reach a new level of use of plant cells produced by controlled cultivation," Dr. Gilbert Gorr, Research and Development Director of Phyton, says. "Our joint objective is to make further natural substances accessible, which so far have been produced with large difficulties and high costs only." Phyton Biotech produces high-quality active pharmaceutical ingredients by plant cell fermentation (PCF) and is worldwide supplier of Paclitaxel and Docetaxel. The company has been inspected successfully by authorities, such as EDQM, EMA, FDA, KFDA, and TGA. Apart from production, Phyton also offers development services for customers. These cover the development of plant cell lines and fermentation processes for plant ingredients as well as the development of synthesis processes of complex substances. Explore further: Plant growth without light control: Synthetic photoreceptor stimulates germination and development

News Article
Site: http://www.rdmag.com/rss-feeds/all/rss.xml/all

The European Medicines Agency (EMA) launched a new initiative Monday called PRIME, which is designed to help expedite the regulatory process for drug makers working on promising medications for rare diseases. PRIME stands for PRIority MEdicines. Its first phase requires participants submit an application.

News Article | October 23, 2015
Site: http://news.yahoo.com/green/

By Ben Hirschler LONDON (Reuters) - A first-in-class drug from Amgen based on a tumour-killing virus was given a green light by European regulators on Friday, paving the way for its approval within a couple of months. The European Medicines Agency (EMA) said its experts had recommended approval of Imlygic, also known as talimogene laherparepvec or "T-Vec", for treating melanoma, making it another option among several new drugs for the most deadly form of skin cancer. “Viral immunotherapy represents a completely new way of treating cancer, so it’s extremely exciting to see T-Vec become the first treatment of this type to gain the green light from European regulators," said Paul Workman, Chief Executive of The Institute of Cancer Research, London.

News Article
Site: http://www.nature.com/nature/current_issue/

Every year brings 528,000 new cases of cervical cancer and 266,000 deaths, linked to human papillomavirus (HPV). We have a highly effective HPV vaccine, but suspicion stands in the way of its adoption in many countries. How can we dispel this mistrust? On 20 November, a report from the European Medicines Agency (EMA) confirmed the vaccine’s safety. The agency had been asked by Denmark to reinvestigate after symptoms of dizziness, fainting, aches and pains were reported in adolescent girls and suspicion fell on the vaccine. It is not the only country to report such events. The good news is that public concern about these reactions is being heard and has prompted further investigation. The EMA report is one of many to confirm the safety of the vaccine and conclude that there is no need to change vaccination policies. The not-so-good news is that not everyone believes them. Evidence suggests that the events were ‘psychogenic illnesses’, psychological reactions that can spread fast, especially when girls are vaccinated in groups at school and witness each other’s reactions. A growing collection of YouTube clips is also fuelling anxieties. My research group studies situations in which public, provider or political trust in vaccines has been broken. We have heard many testimonies of the anxiety that politicians and decision-makers face when pressured about suspected vaccine reactions while also hearing that scientific evidence exonerates the vaccines. We have learned the importance of monitoring public sentiment, responding promptly to concerns and engaging and listening to the public early on when vaccines are being introduced. In some nations, politicians side with the science. In others, they bend to minority opinions. Japan reacted ambiguously to reports of HPV vaccine side effects: it withdrew ‘proactive’ recommendation of the vaccine while it investigated, but continued to provide the vaccine for those who demanded it. The investigations found no clear causal link to the vaccine, but the recommendation remains suspended. In another case, in 2010, we investigated the suspension of HPV vaccine demonstration projects in two Indian states. Vaccination acceptance was high in the projects; the pressure had come from an activist women’s group far away in New Delhi. When the group’s demands for public dialogue about the safety, efficacy and cost-effectiveness of the initiative were not answered, it found, and widely reported, seven deaths among girls who had participated. These deaths were judged unrelated to the vaccine, but the projects never resumed. Nearly five years later, millions of women are missing out on the chance to prevent cervical cancer. One-quarter of global cervical-cancer deaths are in India. Some governments stand by the science even when faced with public panic. Last year, 600 girls in a Colombian municipality reported symptoms after HPV vaccination. Faced with local anxieties and some anger, the Colombian government expressed empathy, and the vaccination programme continues. England reached 87% full-dose coverage in 2014, having averted a potential public-confidence crisis in 2009, when a 14-year-old girl died after being vaccinated. Health officials expressed concern, promptly investigated the girl’s death and found it unrelated to the vaccine. Psychogenic reactions are not unique to HPV vaccination. During the 2009 H1N1 influenza pandemic, there were 23 episodes of mass psychogenic illness in Taiwan’s school flu-vaccination programme. In Iran, people panicked after 10 girls in a class of 26 experienced psychogenic reactions after tetanus shots. I learned about the Iran situation while working with UNICEF just over a decade ago, when I was asked to help plan a nationwide measles campaign — and, specifically, to design ways to pre-empt the type of panic provoked by the tetanus vaccine reactions. The measles campaign was a success, but it took considerable advance work that included gathering local input into communication materials and outreach early in their preparation; engaging young people (the campaign was targeting everyone under 25 years old); and working with schools, local leaders and the media. The HPV vaccine carries unique challenges. Because the first thing it prevents is sexual transmission of HPV, use of the vaccine evokes moral judgements around sexual behaviour. The United States is struggling to get HPV vaccination coverage above 40%. Some parents are anxious that the vaccine will make their daughters more promiscuous, even though multiple studies have found no such effect. Other reports cite ‘embarrassment’ in some cultures about accepting the vaccine. The HPV vaccine touches nerves, and acceptance needs strategies that vary between cultural and political settings. Despite the challenges, more than 80 million girls and women around the world have received the vaccination. We should not underestimate the potential for progress to be disrupted by the mass spread of vaccine reactions and concerns, the amplification that can follow through social media and the vulnerability of political processes, which sometimes find themselves paralysed between public and scientific opinion.

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