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Institute Developing Phone-Linked Graphene Sensors

Wearable graphene sensor patch

Wearable graphene sensor patch (ICFO, Graphene Flagship)

18 Feb. 2019. A research institute is developing sensors made with graphene, worn like a patch on the skin, and connect to a mobile phone to measure key health indicators. ICFO, a photonics research center in Barcelona, Spain is developing the sensors as part of the Graphene Flagship, an EU-funded research initiative that plans to display the devices next week at the 2019 Mobile World Congress, also in Barcelona.

ICFO studies photonics, the science of light generation, transmission, and manipulation. Among the work of the institute is research on sensors, particularly sensors made with graphene and other two-dimensional materials. Graphene is a material closely related to graphite like that used in pencils, one atom in thickness and arrayed in an hexagonal atomic pattern. The material is very light, chemically stable, strong — from 100 to 300 times stronger than steel — and can conduct both heat and electricity, with applications in electronics, energy, manufacturing, and health care. And compared to other materials, graphene is inexpensive to produce.

At Mobile World Congress, the institute plans to unveil 4 prototype sensors made with graphene, including a fitness tracker to measure vital health signs. The fitness tracking sensor is printed on thin flexible plastic and worn like a patch on the skin, containing 6 circuits for data measurement, processing, wireless transmission, and power. The disposable patch measures hydration, oxygen saturation, body temperature, and respiration rate.

A similar patch measures UV exposure from sun light. In both devices, data are then sent to a mobile app that alerts the wearer if specified danger thresholds are crossed. The following video tells more about ICFO’s fitness tracking and UV sensors.

Much of ICFO’s work with graphene sensors applies the material to mass spectrometry, a technology for measuring interactions between light and matter, in this case identifying the composition of chemical samples. In mass spectrometry, chemical samples are showered with electrons to ionize their particles, then sent through a magnetic field that separates the particles for measurement and classification to determine their composition. At Mobile World Congress, ICFO plans to display prototype small-scale spectrometer sensors that can identify counterfeit drugs or help consumers determine ingredients in food products.

Like the fitness tracker, the portable spectrometer connects to a smartphone, but in this case also uses the phone’s camera. “Made up of hundreds of thousands of photodetectors, this incredibly small sensor is highly sensitive to UV and infrared light,” says Frank Koppens, who leads ICFO’s Quantum Nano-Optoelectronic group, in a Graphene Flagship statement.

“This technology,” Koppens adds, “would allow users in the supermarket to hold the camera to fruit and infer which is the most fresh piece. Or, in a more extreme example, the camera could be used for driving in dangerously dense fog by providing augmented outlines of surrounding vehicles on the windscreen.”

Graphene Flagship brings together academic and industry researchers to accelerate graphene applications from university or institute labs into the marketplace. It’s Europe’s largest research initiative with a budget of €1 billion.

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Genetic Engineering, Silencing Boost Plant Output

Growing test plants

Donald Ort, left, with co-authors Paul South, center, and Amanda Cavanagh, right, study how well tobacco plants modified to boost photosynthesis perform beside unmodified plants in real-world conditions. (Claire Benjamin, RIPE, Univ of Illinois – Urbana)

18 Feb. 2019. An agricultural research lab uses genetic engineering and gene silencing to produce crop plants that increase their yields by more than 40 percent. A team from University of Illinois in Urbana described their techniques and results on Saturday at the American Association for Advancement of Science or AAAS annual meeting, and last month in the journal Science.

Researchers from the University of Illinois genomic biology institute led by plant biologist Donald Ort, with colleagues from the Agricultural Research Service at U.S. Department of Agriculture, are seeking more efficient photosynthesis processes that convert sunlight, carbon dioxide, and nutrients into larger and more plentiful plant life. While advances in plant science called the Green Revolution produce significantly more crops than before, say the researchers, the photosynthesis process remains inefficient, requiring large energy inputs. A more efficient photosynthesis process could make it easier and cheaper to produce more crops, needed to feed an exploding global population.

A key stumbling block in making photosynthesis more efficient is the plant enzyme ribulose-1,5-bisphosphate carboxylase/oxygenase or Rubisco that absorbs and converts carbon dioxide in the air to sugar. But that process is slow and prone to errors, since Rubisco cannot always discriminate between oxygen and carbon dioxide. The confusion between oxygen and carbon dioxide leads to toxic by-products in the plants, requiring an additional process known as photorespiration to recycle those by-products. That extra process involves 3 different parts of plant cells to recycle the toxins, which needs considerable energy and detracts from the plant’s photosynthesis.

“Crops like soybean and wheat waste more than 30 percent of the energy they generate from photosynthesis dealing with this glitch,” says Ort in a statement from the project’s sponsor Realizing Increased Photosynthetic Efficiency or RIPE, “but modeling suggested that photorespiratory shortcuts could be engineered to help the plant conserve its energy and reinvest it into growth.” That modeling led Ort and colleagues to try 3 different methods to make a plant’s metabolic system more efficient.

The researchers worked with tobacco plants to test these different techniques, since tobacco is easier to modify and it produces larger leaves than most plant crops. The team engineered the tobacco genome with combinations of genes governing metabolic processes in algae and E. coli bacteria, a well-researched microorganism. Initial greenhouse tests showed some increases in photosynthesis efficiency, but another part of the recycling process in the plant’s metabolism, which restricts the elimination of the toxins, limited those gains.

As a result, the researchers added another step to the process called RNA interference. RNA is made up of nucleic acids produced by genes with the instructions to cells coded from DNA to produce proteins. With RNA interference, those instructions are interrupted or silenced, preventing production of proteins from specific genes, while limiting the effects on other genes, RNA, and proteins.

The team then tested the most promising genetic engineering strategy, both with and without RNA interference. In tobacco plants grown under real-world conditions in the field over 2 growing seasons, plants with both the re-engineered photorespiration processes and RNA interference grew more than 40 percent more biomass than wild-type tobacco, while genetic engineering alone yielded 25 percent more biomass.

Ort expects that translating these techniques into food crops could take as long as 15 years, due in part to regulatory approvals. But RIPE, funded by the Bill and Melinda Gates Foundation and others, says small growers in developing regions will have royalty-free access to seeds produced with this technology.

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Scenes From the AAAS Meeting, Fun With Science

17 Feb. 2019. There are few things in life more fun than watching kids interact with science. And, there’s no age limit to that enjoyment. Here are a few images from the annual meeting of the American Association for Advancement of Science, held this weekend in Washington, D.C.

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MIT Spins-Off 32 Start-Ups in 2018

Lesley Millar-Nicholson

Lesley Millar-Nicholson describes technology transfer at MIT (A. Kotok)

16 Feb. 2019. Research done at Massachusetts Institute of Technology in 2018 led to creation of 32 new start-up enterprises as well as hundreds of licenses and patents. Lesley Millar-Nicholson, director of MIT’s Technology Licensing Office, revealed these statistics yesterday at the American Association for Advancement of Science, or AAAS, annual meeting in Washington, D.C.

Millar-Nicholson was one of 3 speakers on a panel describing technology transfer at universities and national laboratories, as well as upcoming changes in U.S. government technology transfer policies. Technology transfer is the process of converting new ideas into tangible products or services, and includes intellectual property protection and licensing, new venture creation and incubation, and economic development, according to AUTM, the group that used to be called Association of University Technology Managers.

MIT, says Millar-Nicholson, benefits from its record as a leading science and engineering institution, as well as long-standing policies that encourage collaboration with business. She notes that MIT’s first outreach to industry began in the 1930s, and formal business liaison office opened in 1948. In addition, its location in Cambridge, Massachusetts puts the campus in close proximity to many businesses large and small, making it possible for “collisions with the private sector” in nearby coffee houses and bars. More important, however, are some 50 incubators in the vicinity of MIT offering coworking or lab space, funding, networking, mentors, and internships.

Rather than leave the innovation process to chance, MIT offers 85 different programs on innovation and entrepreneurship. As a result of this supportive environment, says Millar-Nicholson, MIT turned its $1.7 billion in sponsored research funding last year into 822 disclosures — the initial documentation of a new technology — 425 new patent applications, 360 patents issued, 154 licensing and option deals, and 32 new start-up companies.

She adds that despite its name, MIT’s Technology Licensing Office does much more than manage intellectual property. Her group is taking on more responsibility in helping students and faculty find external entrepreneurship programs from the federal government, like National Science Foundation’s I-Corps, and those in the community. Millar-Nicholson advises, however, not to try replicating the MIT experience elsewhere. In her previous job, for example, she needed to build a university’s technology transfer and entrepreneurship programs almost from scratch.

William Farris, an associate lab director at National Renewable Energy Laboratory, or NREL, in Golden, Colorado, described a much different approach to technology transfer. Farris, responsible for innovation outreach at NREL says his organization seeks out partners for converting its research findings into new products and services. This approach, says Farris, better fits the national laboratories model where the main customer is the U.S. Department of Energy that funds their work.

That work often involves conducting early-stage, high-risk basic and some applied research on energy-related technologies. And as a result, national labs in the U.S. generate more patents and licenses than any other government entities. But unlike many universities, national labs don’t produce many spin-off enterprises, choosing instead to rely on private-sector partnerships to convert research discoveries into marketable products and services.

Overall, says Farris, national labs engage with more than 3,000 external partners, mainly companies, but also state governments. At NREL, the lab has more than 700 partner relationships, with 528 individual companies. Last year alone, NREL started 272 engagements. Farris described 2 incubator programs connected to NREL — one with banking company Wells Fargo and the other with Shell — that support start-up companies advancing the lab’s research results.

Walter Copan, Under Secretary of Commerce for Standards and Technology and director of National Institute for Standards and Technology in Gaithersburg, Maryland described NIST’s Return on Investment initiative aimed at updating the U.S. government’s technology transfer policies. Copan says this initiative addresses “systemic challenges” to transferring technology to the American economy, resulting from the government’s $175 billion investment in research and development.

In December 2018, NIST issued what it calls a draft “green paper’ outlining proposals to reduce regulatory and administrative burdens, increase private sector engagement, and encourage technology entrepreneurship at federal agencies. The agency expects to issue the final ROI initiative document in March 2019.

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Ships Are Becoming Safer With Technology

– Contributed content –


(A. Kotok)

16 Feb. 2019. Digital technology has been transforming the maritime industry, allowing tasks to be automated and allowing better quality data to be collected. This has had an incredible impact on the safety of ships. Here are just several big technological developments in safety that future ships may depend on.

Improved weather forecasts

Being able to predict sea conditions is essential for any ship. Today’s ships use computers with satellite information to give very accurate predictions of the ocean ahead. This can allow ships to safely navigate past dangerous storms. Weather forecasts are still not perfect, however they could be in the future – algorithms are currently in the works to create computer models of the Earth’s atmosphere and oceans that can react to every change in weather and predict the precise path of storms, although it could be a good few years until these algorithms are perfected.

IoT maintenance

The internet of things (IoT) – also known as smart technology – involves connecting various objects to the internet so that they can be remotely controlled and monitored. Within a ship, it’s now possible to connect all kinds of appliances and machinery this way from the engines to the ship’s lighting. This can allow the entire ship to be monitored for faults from a single computer rather than getting a technician to individually service every part of the ship. Such technology can even predict faults before they happen by using sensors to monitor the wear and tear of parts. In the future, ships could even have robots that are able to carry out these repairs remotely.

Passenger screening with wearable tech

A company called ScanReach has been making developments into passenger safety that could transform safety and security within cruise ships and ferries in the future. Every passenger can be given a wearable wristband, allowing their location to constantly be monitored within the ship. If a passenger goes missing, this technology could help to locate them.

Drone surveillance

Slips and falls among ship workers are common and can lead to nasty injuries. This can lead to costly lawsuits for shipping companies due to a violation of the Jones Act – there are a growing number of maritime accident attorneys who handle Jones Act claims. To help improve safety on deck, ships are now starting to use drones for surveillance. This can prevent employees having to climb slippery ladders to monitor the condition of communication masts and other parts of the ship.

Virtual reality training

VR is becoming a great training tool for ship crews by helping to simulate storms. This can allow ship staff to prepare for these situations so that they can react to them more competently if they arise. This could help to save lives in emergencies.

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Blockchain and Science, Not Ready for Prime Time

James Evans

James Evans discusses blockchain at AAAS conference (A. Kotok)

15 Feb. 2019. A panel of data and behavioral scientists envision great potential for blockchain in science, but show few cases of blockchain in use today among researchers. The discussion took place at the annual meeting of American Association for Advancement of Science, or AAAS, in Washington, D.C.

Blockchain is a system for capturing data about a transaction in a network, but with the data distributed among the various parties to the transaction. Data about the transaction are broken up into blocks, with each block connected in a chain. Each block is also time-stamped and encrypted with an algorithm giving it a unique identifier or fingerprint, also linked mathematically to the previous block in the chain. This linking of uniquely identified and encrypted blocks in the chain ensures the integrity of the data, as well as protects the data from hacking.

James Evans, a University of Chicago sociologist outlined serious problems of reproducibility in science that blockchain could address. Evans says the lack of reproducibility is leading to a “crisis of confidence” in science, with a lack of robustness reinforced by known communities of researchers, rather than seeking out lesser-known, disruptive scientists. Blockchain, says Evans, can make possible registration of hypotheses by researchers, with subsequent data and analysis linked together by disparate groups. This type of process could open up the conduct of science, adding more sources of ideas to the mix.

Krishna Ratakonda, chief technology officer for IBM’s blockchain solutions in Yorktown Heights, New York, says blockchain offers a technology to build trust among disparate groups, enabling more parties to conduct data gathering, curation, and analysis rather than concentrating it all in one lab. “Why have one group do everything?” asks Ratakonda. With blockchain, research can be done in more of an ad hoc manner, leveling the playing field between established labs and more innovative groups.

Kweku Opoku-Agyemang, an economist with Center for Effective Global Action at University of California in Berkeley, says blockchain makes possible a “tamper-proof, indelible time-stamped record of research hypotheses and other decisions.” Opoku-Agyemang discussed pre-analysis plans, a step that requires stating and documenting a hypothesis before data gathering and analysis. These pre-analysis plans can be time-stamped with blockchain and connected to data collection and analysis in a more robust and trusted process.

While the idea of blockchain has promise, the panel members could offer few examples of its use in scientific practice. Opoku-Agyemang mentioned one test of blockchain with peer review. Even more concerning, Ratakonda told of a blockchain application in the food industry, to better track food items through the supply chain. One spice manufacturer, says Ratakonda, took 5 years before the company could furnish data for the project, suggesting more than technology needs to be considered.

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Disclosure: The author owns shares in IBM.

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Slips And Falls, Underestimated Workplace Hazards

– Contributed content –

Accident Risk Banana Peel


15 Feb. 2019. Workplace safety is a priority for all businesses because if you aren’t creating a safe work environment for your employees, you’ll have to deal with injuries and possibly fines for breaking health and safety codes. In dangerous industries like construction or manufacturing, there are all sorts of hazards and dangerous equipment that you need to deal with, but people often overlook the simpler issues.

Trips and falls are still one of the biggest workplace dangers in any industry and the majority of the time, they’re easily avoidable. In 2016, 697 people died in falls and almost 50,000 were seriously injured and had to take time off work. A significant amount of those deaths were caused by same level falls, rather than people falling from a height. Usually, trips and falls are caused by sloppy health and safety practices and they could have been avoided if everybody was following procedure properly. If you haven’t really considered it before, here are some of the best ways to avoid slips and falls in your workplace.

Regular cleaning

If the workplace is messy and there are things lying around on the floor or spills that haven’t been wiped up properly, there is an increased risk of falls. That’s why it’s so important that you have a regular cleaner to keep the place tidy. As well as hiring cleaners, you should also stress the importance of keeping the workplace clean to your employees. It’s not a big job if everybody is responsible for their own work area and they make sure that they leave it clean and tidy at the end of the day.

Good flooring

Getting the right flooring is another simple way that you can stop people from slipping over. Some materials are a lot better than others. Concrete, for example, is ideal for any workplace because if it’s maintained properly, it has great non-slip properties. You can use stained concrete so it still looks good and you’re keeping your employees safe at the same time. If you’re going to go for carpets, it’s best to use industrial carpets that are designed to give good grip so people are less likely to slip. You need to make sure that you’re maintaining the carpets properly as well because if they come up at the edges, that’s a big trip hazard.

Proper lighting

People always focus on removing obstacles which is very important, but visibility is equally as important. If people can’t see what they’re doing properly, they’re far more likely to miss any potential trip hazards. Always make sure that you’ve got good lighting around the office, especially along any walkways where people are most likely to have a fall. In areas where people are often carrying things, you should install automatic lighting so they don’t have to worry about switching the lights on while they’re trying to carry a heavy load.

Trips and falls don’t seem that serious but they’re one of the leading causes of workplace injury so it’s essential that you take steps to combat them.

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Asthma Drug Shown to Lower Airway Muscle Mass

Asthma inhaler and pills

(University of Leicester)

14 Feb. 2019. An experimental drug is shown in a clinical trial and computer modeling to reduce the mass of smooth muscle tissue that builds up in airways of people with asthma. A team from University of Leicester in the U.K., University of British Columbia in Vancouver, Canada, and drug maker Novartis describe their findings in yesterday’s issue of the journal Science Translational Medicine.

Asthma is a chronic condition, where the airways become inflamed and narrow, causing wheezing, shortness of breath, tightness in the chest, and coughing for periods of time. Among asthma’s underlying causes are infections, pollutants in the air, and allergies to pollen, molds, fungi, or dust mites that trigger airway inflammation. A study calculating the global burden of respiratory diseases, estimates asthma affected some 350 million people in 2015, making it the most common chronic respiratory disorder, and responsible for about 400,000 deaths each year.

Most of today’s treatments for asthma aim to reduce inflammation in the airways, but the authors note that a build-up of smooth muscles in the airways also contribute to their narrowing and the asthma symptoms. The team led by Leicester respiratory medicine professor Chris Brightling is assessing a new drug made by Novartis called fevipiprant to address both inflammation and smooth muscle mass build up in the airways. Fevipiprant works by blocking a protein associated with airway inflammation and muscle build-up, prostaglandin D2 type 2 receptor.

A mid-stage clinical study tested fevipiprant in 61 participants diagnosed with asthma against a placebo. Participants were randomly assigned to take the fevipiprant capsules or placebo twice a day for 12 weeks. The study team measured the amount of eosinophils, or disease-fighting white blood cells in the airway saliva-mucous discharge as an indicator of efficacy, as well as signs of adverse effects, and scores on an asthma control questionnaire.

The trial’s results show participants taking fevipiprant had fewer asthma symptoms, improved lung function, less inflammation, and reduced smooth muscle mass. While the trial’s results supported further development and testing of fevipiprant, data showing fewer eosinophils in the airways still did not explain the all of the reduction in airway smooth muscle mass. Something else was going on.

A computational model conducted by colleagues at University of British Columbia confirmed reductions in eosinophilia from fevipiprant had help in reducing smooth muscle mass in the airways of people with asthma. The model indicated the reduced numbers of eosinophils were accompanied by lower accumulations of myofibroblasts and fibrocytes, precursor connective tissue cells associated with fibrosis in lung inflammation and asthma. Lab tests with fevipiprant show the drug lowers the recruitment of myofibroblasts and fibrocytes in remodeling smooth airway muscle tissue, as well as reducing eosinophils.

“Our latest research,” says Brightling in a University of Leicester statement, “gives us a better understanding of the mechanisms behind the efficacy of the drug and how changes in one part of the airway wall can impact on others. Our findings suggest that fevipiprant could have positive long-term effects upon the progression of the disease through remodeling, as well as improve symptoms and reduce attacks.”

Himanshu Kaul, a postdoctoral researcher at University of British Columbia, who led the project’s computational modeling says the technology could also “play a role in furthering precision medicine by helping predict the optimal intervention tailored to individual patients given their genomic information.”

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Getting Customers To Trust Your Online Business

– Contributed content –

E-commerce screen on phone

(PhotoMix Ltd,

14 Feb. 2019. We live in a cynical age, and with some justification. There have been enough shady actions from the world’s biggest companies to make people question who, exactly, are the good guys in the world of business. As such, people are less likely to blindly hand over their cash to a business that they don’t know all that much about. Trust must be earned. This might be straightforward enough in the real world, but what about in the online world, where business owners don’t have the luxury of face to face contact? Below, we take a look at some tried and tested methods for developing trust via your website.

Be human

You may operate in digital code, but there’s a real person behind the scenes, so make sure your website visitors know it. You can invite trust simply by sharing some information and a photograph of yourself, if appropriate. It doesn’t have to be anything overly deep; a short summary of who you are, where your based, and the motivation behind the website will be a good place to start. People use the internet but they don’t always love it — the human factor reminds them that it’s still part of the “real world.”

Have great content

People trust authority. If it seems like someone knows what they’re doing and talking about, then people pay attention. So how do you claim your position of authority via your website? You do it by having great content. For example, on your blog you can tell visitors the benefits of using whatever products or services you provide. This shows your visitors that you know what you’re talking about it, but, more than that, it also helps boost your search engine rankings and shows that time, care and professionalism has gone into the website, which is another indicator that trust should be given.

Avoid underhanded tactics

You really can’t fool the general public. Well, you can fool them once, but that’s it. As such, it’s much better for the long-term health of your business if you avoid any underhand tactics. For example, let’s think about your pricing. If you list the price as one thing but then sneakily add in another charge just before the customer pays, then there will be doubts about how your company operates. Basically, any sort of deception should be avoided, even if you think it might help boost sales. It will in the short-term, but no trust will be established, and that means your long-term prospects will be poorer because of your actions.

No quibble returns

You can’t abuse the trust people have placed in you by making an order. It has to stretch right through for the entire customer cycle. Let’s say, for example, that someone is unhappy with their purchase (for whatever reason), and wants to return it. While there are some scenarios when you could refuse, it’s nearly always better just to accept the return, unless you think some foul play is at hand. Indeed, one of the best indicators that a website is trustworthy is when they have their returns policy clearly outlined, for all to see. And of course, if you’ve espoused your generous returns policy, then you have to honor it. The returns policy is actually a big factor when a potential customer is deciding whether to make a purchase or not.

Be available

One of the reasons why people like brick and mortar stores is because they know that if they need to speak to someone, they can visit in person and talk with someone. In the online world, this is not possible. That’s why it’s doubly important that you make yourself available for your customers to talk to, in a number of ways. You can start by listing a phone number for customers to call — people like knowing that they can pick up the phone and chat if they need to. You’ll also want to have an email contact address easily located on your site, and systems in place to answer them quickly. Social media channels, especially Twitter, can also be used to quickly respond to customer’s questions.

Take data seriously

One of the reasons why people are so skeptical about online companies these days is because, well, they’ve been burnt before by online companies. The number of data breaches has risen considerably in recent years, and while “data” may sound unimportant, what it really means is “people’s personal information.” You can help to develop trust by making sure that the security of your site is up to date and fool-proof. If for whatever reason your data is compromised, then you need to tell your customers immediately — you might lose their trust and business, but respect will still be there. If you delay, you won’t even have that, and it’ll be the end of your business.

Other people’s opinions

It’s all good and well telling your customers that you’re trustworthy and dependable, but you’ve got a pretty big stake in having them trust you. You’re biased, essentially. There’s a reason why people pay so much attention to reviews and the experiences of other people, and that’s because they’re not biased. They’re just customers. So if you have a track record of delighting customers, then put their positive words to good use. You can use a service like to solicit feedback, which can then be published instantly on your website. The experience of others really does have an impact on how people view your business, so make the most of their words.

Handle issues

Every company in the world makes mistakes. You’re not going to get everything right. The quality of your company won’t be reflected by whether you make mistakes or not, but how you respond to them. If you’re proactive in handling issues and making sure that your customers are satisfied, then they’ll trust you. Do everything you can to make sure that the people using your service come away happy with your service, and they’ll stick around – people rightly like businesses they can depend on.

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FDA Approves 25 Precision Meds in 2018


(Alnylam Pharmaceuticals Inc.)

13 Feb. 2019. An organization advocating for medicines addressing a person’s unique chemical composition rather than disease symptoms says U.S. regulators approved 25 of those drugs in 2018. The Personalized Medicine Coalition in Washington, D.C. says in a report released today these therapies represent more than 4 in 10 of the new drugs approved by the Food and Drug Administration last year.

Personalized or precision medicines are those targeting the underlying chemistry of proteins expressed by an individual rather than the state of a disease. In October 2018, FDA issued regulatory guidance on therapies addressing proteins acting as indicators, known as biomarkers, often a result genetic changes such as mutations, which may be associated with more than one disorder. Also in some cases, conventional one-size-fits-all drugs may address these disease-causing proteins, but affect other functions in the body as well, resulting in undesired side effects.

FDA lists 59 new molecular entities — a term covering both chemical drugs, agents, and biologic therapies — approved in 2018. Personalized Medicine Coalition rates 25 of those new treatments, or 42 percent, as personalized medicines. Of the 25 approvals, 10 targeted biomarkers associated with cancer. Included in these 10 new therapies is Vitrakvi made by Loxo Oncology Inc. in Stamford, Connecticut addressing a molecular condition resulting in cancer-causing proteins that encourage solid tumor onset, growth, and development in various parts of the body. In January of this year, as reported by Science & Enterprise, Eli Lilly and Co. bought Loxo Oncology for some $8 billion.

Another key approval noted in the report is for Onpattro, made by Alnylam Pharmaceuticals Inc. in Cambridge, Massachusetts. Onpattro treats peripheral nerve disease affecting nerves in the body other than the brain or spinal cord. The disease results from accumulations of amyloid protein fibers on peripheral nerves in tissues and organs, leading to loss of sensation or pain in the limbs, hands, and feet. The condition also can cause life-threatening disruptions of heart, kidney, eye, and gastrointestinal tract functions. Onpattro works by interfering with ribonucleic acid, or RNA, providing instructions from the genes to produce the errant proteins, with small interfering RNAs carried by lipid, or natural oil nanoscale particles, infused directly to the liver where the proteins are made.

The report credits FDA for creating a regulatory environment that supports development of precision medicines. In addition to the guidance published on treatments targeting biomarkers, the agency also issued a document on next-generation sequencing for diagnostics designed to test for mutations responsible for diseases that precision medicines could serve. In addition, FDA recognized a public database of genomics and diseases, the ClinGen Expert Curated Human Genetic Data resource, to provide standard benchmarks for evaluating diagnostics using genetic data to detect disease conditions based on variations in a person’s DNA.

However, the report also slams a Trump Administration policy begun in August 2018 to require “step therapy” for patients covered by Medicare Advantage. Under step therapy, doctors are required to first try less expensive standard treatments before more expensive therapies, even personalized medicines addressing the patient’s own molecular make-up.

“Driving treatment decisions by cost considerations rather than determining what treatment would work best for an individual patient,” notes the report, “fundamentally conflicts with personalized medicine, and in many cases will increase downstream costs brought on by continued progression of disease and more adverse side effects.”

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