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Long-Term Effects Shown from Hemophilia Gene Therapy

Drop of blood

(Alden Chadwick, Wikimedia Commons)

22 May 2018. Participants in a clinical trial testing a one-time genetic therapy to treat a rare form of hemophilia sharply reduced their bleeding incidents after a year, with few adverse effects, none considered serious. Results of the trial, sponsored by Spark Therapeutics in Philadelphia, are scheduled to be reported today at a meeting of the World Federation of Hemophilia in Glasgow, Scotland.

Spark Therapeutics is a developer of gene therapies to treat inherited diseases, including hemophilia-B, a disorder where the blood does not coagulate, due to a missing protein that mixes with blood platelets. About 8 in 10 people with hemophilia have type A of the disease, where the protein clotting factor 8 is missing. In type B, clotting factor 9 is missing. Factor 9 is made in the liver, and circulates dormant in the blood stream until a blood vessel is damaged, when it is activated by other proteins that set in motion the processes to coagulate into a clot.

The Spark Therapeutics technology is based on research conducted at Children’s Hospital of Philadelphia, a teaching hospital of University of Pennsylvania. Healthy genes are transferred into patients to replace damaged or mutated genes with engineered adeno-associated viruses, benign microbes designed to deliver genetic material, in this case to the liver, where factor 9 is produced. Among Spark’s founders is Katherine High, a hematologist at Children’s Hospital and UPenn who pioneered adeno-associated virus delivery of gene therapies, and is now president of the company.

The clinical trial is an early- and intermediate-stage study assessing the gene therapy’s safety, but also changes in activity levels of factor 9 in participants’ blood. The trial recruited 15 individuals with hemophilia-B at several sites in the U.S., Canada, and Australia. Participants were given a single gene-therapy treatment, code-named SPK-9001, then followed-up at 12 weeks and tracked for 1 year overall. All participants in the study were given the gene therapies; there was no placebo or comparison group.

None of the gene therapy recipients reported serious adverse effects, including blood clotting events, during that period. Two of the participants, however, were found to have elevated enzyme levels in their livers after 12 weeks, and were treated with corticosteroids. At the 12-week checkpoint, the other 13 participants reached stable levels of factor 9 in their blood of more than 12 percent, which continued over the year they were monitored. For 10 of the participants receiving the original SPK-9001 formulation, factor 9 rates ranged from 14 to 77 percent. Another 3 recipients of an enhanced version of SPK-9001 reported factor 9 rates of 38 to 55 percent.

The company also reported on other efficacy measures not originally specified for the trial. All 15 recipients found they could discontinue their supplemental infusions of factor 9 concentrates. In addition, annualized rates of bleeding incidents or supplemental infusions dropped to less than 1 percent each.

Spark is developing SPK-9001 with drug maker Pfizer. As reported by Science & Enterprise in December 2014, Spark is licensing SPK-9001 to Pfizer in a deal that could bring Spark as much $280 million. Under the agreement, Pfizer is responsible for late-stage clinical trials of SPK-9001, and that transition is expected to complete this summer.

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Disclosure: The author owns shares in Pfizer

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Self-Repair Developed for Soft Materials Circuits

Digital counter tests

Tests of self-repairing circuits with a digital counter that keeps functioning, even when broken and material is removed. (courtesy, Nature Materials)

22 May 2018. Materials scientists and engineers developed the ability for electronic circuits in soft materials, like those found in wearable devices, to repair themselves if ruptured. A team from Carnegie Mellon University in Pittsburgh describes the technology in yesterday’s issue of the journal Nature Materials (paid subscription required).

Researchers led by mechanical engineering professor Carmel Majidi are seeking ways to make more robust electronic circuits in soft materials used in robotic devices that come in contact with humans, as well as wearable devices linked to mobile systems. Their goal, says Majidi in a university statement, is to have circuits in these materials restore their functions should they break. “Other research in soft electronics,” notes Majidi, “has resulted in materials that are elastic and deformable, but still vulnerable to mechanical damage that causes immediate electrical failure.”

Majidi’s Integrated Soft Materials Lab studies new types of electronics that simulate the mechanical properties of human tissue. The researchers work with highly elastic silicone polymers having tiny microscale channels embedded in the material. Those channels contain liquefied metal alloy, such as galium, that remains in liquid form, even as the surrounding flexible materials bends and stretches.

In the new study, the researchers tested the ability of the liquid metal to restore its connections if broken. The circuits in this case are made with liquid metal droplets, which if the circuits are ruptured, reconnect with other nearby droplets, enabling the electronic connections to be restored. The team says this rerouting process takes place spontaneously, without manual intervention or external heat sources.

Tests of the materials show restoration of these circuits, when the circuits are severed, punctured, and even if material is removed. The researchers also evaluated the circuits under more real-life conditions in working devices, such as a digital counter and a miniature quadruped robot. The results show the digital counter circuits repair themselves when broken and the robot continues to function, even after encountering significant damage (see image below).

“The unprecedented level of functionality of our self-healing material,” says Majidi, “can enable soft-matter electronics and machines to exhibit the extraordinary resilience of soft biological tissue and organisms.” In addition to wearable devices and soft robotics, the researchers envision self-repairing circuits being used by first-responder robots performing human rescues even if damaged, and with inflatable structures in remote locations, even under extreme environmental conditions, such as on the planet Mars.

Miniature quadruped robot

Miniature quadruped robot keeps functioning, even after researchers physically break circuits (Carnegie Mellon University)

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Taking Care of Tech Issues in the Workplace

– Contributed content –

Computer monitor and teapot

(Pexels.com)

22 May 2018. We’re living in a technological age and everyone has been drawn into making use of various tech products and services in all aspects of their lives, from their homes to their workplaces. Now, if you experience tech problems at home, they tend to be (at most) an inconvenience. Usually, they only affect your entertainment. However, tech problems in the workplace can cause severe disruptions and delays which can have a knock-on effect on business, negatively affecting your professional image and potentially reducing your profits. So, let’s take a look at a few common tech problems and consider how to resolve them!

Develop your own software

If you’re using premade software to complete your work on, chances are that it’s going to have its limitations. You should bear in mind that it is produced with the mass market in mind, so its features and functions are going to be generalized to meet as many people’s needs and requirements as possible. So, if you want software that is going to do everything that you need it to in a manner that suits your business plan, you should look into developing your own software. This will provide you with something that is unique and functional. However, unless you have an extensive knowledge of coding, you’re likely to struggle to bring your ideas to life alone. This is where a reliable software development company can come in handy. A consultation will allow them to completely understand what you have in mind and make your concept a reality.

Make use of professional IT support

Every now and then, something is going to happen that throws your tech into disarray. Identifying the problem can be a long and drawn-out process if you don’t know exactly what you’re looking for, leaving you and your employees offline for extended periods of time. This is bad for business. So make sure you have a professional IT support team on hand to help resolve any issues that might arise. They should monitor your server and computers around the clock, identifying warning signs of potential problems and rectifying issues before they even manifest themselves. This minimizes interruptions and keeps your company in operation at all times. Perfect!

Laptop keyboard

(Pexels.com)

 

Backup your documents

Your business will run smoothly as long as you have all of your documents to hand and the best place to store documents is on your desktop computer or laptop. Why? Well, physical documents are easily destroyed. You could easily spill something on them, they could blow out of the window on a gust of wind. They can also be difficult to find and when time is money you don’t want to spend hours at a time searching for a single document that’s lost somewhere among heaps of paperwork or tucked in some obscure folder in an extensive filing cabinet. By storing your documents on your laptop they are no longer in a tangible form that can be easily destroyed, and all you have to do bring them up, all you have to do is type their name into a search bar et voila! You have them!

However, when storing documents in digital form, you need to ensure that you have everything backed up. If you want to go down a traditional route, you could back them up onto a hard drive, but nowadays there are more advanced options too. Consider saving copies of all of your files to the cloud. The cloud allows you to store everything remotely and access everything you’ve saved at any given time from any device that you can log into.

Install anti-virus

If you are using Microsoft devices that use Windows, it is absolutely essential that you use anti-virus. This is specialist software that protects your device from computer viruses. It detects threats and destroys them. Now, Microsoft dominates the market when it comes to computers, laptops, and various different pieces of software, so hackers are more likely to design viruses to attack Microsoft devices. However, other alternatives are still prone to attack, so generally speaking it’s a good idea to invest in anti-virus no matter what you’re doing your work on.

While we may have addressed more potential tech issues than you might have initially had in mind, we’re only covering some of the basics and common issues here. There are plenty more tech problems that can present themselves to you in the workplace. So keep an eye out for them. However, by following the above advice, hopefully you can reduce the frequency with which you come into contact with common tech problems.

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Gene Therapy Safety Study for Heart Failure Underway

Heartbeat graphic

(Maxpixel.net)

21 May 2018. An early-stage clinical trial is testing gene therapy to treat malfunctioning heart muscle cells in people with heart failure, where the heart cannot pump enough blood for the body. The study, sponsored by Precigen Therapeutics Inc., a subsidiary of synthetic biology company Intrexon Corp. in Germantown, Maryland, that says the first patient in the trial began receiving gene therapy treatments.

Precigen says the treatments, code-named INXN-4001, are designed to help people with heart failure rebuild their damaged heart muscle cells. Heart failure is a condition where the heart cannot pump enough blood to meet the body’s needs, a condition affecting some 5.7 million people in the U.S., according to Centers for Disease Control and Prevention. Most cases of heart failure affect both the left and right sides of the heart, although in some cases only one side is affected. The leading causes of heart failure are conditions that weaken or damage the heart, including coronary heart disease, high blood pressure, and diabetes.

INXN-4001 is a synthetic DNA molecule containing genes with instructions for producing proteins that help build heart muscles. The genes are delivered as a plasmid, a circular DNA molecule produced separate from chromosomes, and are a characteristic of bacterial DNA. In this case, the plasmid contains genes that carry instructions to cells for producing three proteins needed by damaged cardiomyocytes, cells in heart muscles. The company cells the proteins address multiple malfunctions in damaged heart muscle cells.

The early-stage clinical trial is testing the safety of INXN-4001 in a small group of heart failure patients. The study is enrolling 12 patients at University of Arizona’s heart health center in Tucson who suffer from heart failure. The patients also use a left-ventricle assist device, a surgically implanted mechanical pump that helps the damaged heart pump blood throughout the body. Participants are receiving two doses of INXN-4001, and are being followed for 12 months following their treatments, with the study team looking primarily for occurrences of adverse effects within 6 months of their treatments.

Helen Sabzevari, president of Precigen, says in a company statement that the trial is “also the first use of the retrograde coronary sinus infusion procedure in left ventricular assist device patients.” Retrograde coronary sinus infusion delivers the plasmids with a catheter through the coronary sinus, a primary vein, instead of using benign viruses, often employed for delivery of gene therapies. The study team is also tracking the ability of patients to wean themselves from their left-ventricle assist devices, measured by their ability to walk for 6 minutes, and quality of life. In addition, the trial is testing the feasibility of wearable biosensors to collect data on the patients’ daily activity.

Precigen was founded in 2017 to develop and commercialize synthetic gene and cell therapies initially discovered by Intrexon, and is a wholly-owned subsidiary of Intrexon Corp. The company says it is also developing treatments for cancer and autoimmune disorders.

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Trial Testing Gene-Edited, Modified Oilseed Plants

Camelina plant

Camelina plant (Rothamsted Research)

21 May 2018. An agricultural science lab in the U.K. is beginning research on sustainable methods for growing genome-edited camelina plants, along with modifying the plant’s genetics by adding genes from other plant species. The study by Rothamsted Research in Harpenden, England is expected to start later this month.

The research team led by Rothamsted plant scientist Johnathan Napier is studying these techniques to boost production of omega-3 fatty acids in camelina plants. According to the U.S. Department of Agriculture, camelina was long considered a weed, but is now recognized as an oilseed crop, with oils making up 30 to 40 percent of its seeds’ weight. Camelina oil is marketed largely in Europe in salad dressing and for cooking, for its high content in polyunsaturated fats, including omega-3 fatty acids.

In addition to camelina, omega-3 polyunsaturated fatty acids are found in flax plants — another name for camelina is “false flax” — as well as nuts and fish. Their three main types are alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), all of which are either made in small quantities in humans or in the case of ALA, not at all. The acids are part of cell membranes and found in higher levels in the eyes, brain, sperm, heart, lungs, immune system, and endocrine glands. Because the body produces so few omega-3 fatty acids, they need to be consumed in food or with supplements.

Napier and colleagues will test genetically modified camelina plants, with genome-edited and wild-type varieties. Some 17 varieties of camelina, genetically modified to include algae genes, will be evaluated for their production of EPA and DHA oils. Other modified varieties are being assessed for production of natural pigments with anti-oxidant properties known as ketocarotenoids, as well as wax esters, another type of fatty acid, and for improved structural traits including stem thickness and photosynthetic capability.

Two of the camelina varieties tested in the trial will be genome-edited. The researchers, with colleagues in France, are editing the camelina genome with Crispr, short for clustered regularly interspaced short palindromic repeats, using Cas-9 enzymes to perform the edits. In this part of the study, the team is looking into the feasibility and efficiency of growing genome-edited strains, which the researchers say could produce more precise results and more quickly than with adding genes from different species. Napier adds that the study also “will improve our understanding of lipid metabolism.”

Editing the genomes of plants may also bypass European Union and U.K. rules on genetic modification, which the Rothamsted researchers consider onerous. In a February 2018 essay, Rothamsted crop scientist Nigel Halford notes that genome editing techniques like Crispr-Cas9 knocks out specific genes, causing mutations much like those that occur in nature, such as when plants are exposed to chemicals or radiation. These modifications are already exempt from EU genetic modification regulations, and thus, says Halford,  genome-edited varieties should be exempt as well, since the EU’s rules were drawn up a decade before the emergence of genome editing.

In January 2018, a European court issued a preliminary opinion that any mutation-causing change that could occur naturally should be exempt from the EU regulations on genome modification, ostensibly including genome editing, which the full court is now considering. In March, George Eustice, the U.K. Secretary of State for Environment, Food and Rural Affairs answered a parliamentary question in much the same way, saying “the Government’s view is that specific regulation of this technology is not required where the induced genetic change could have occurred naturally or been achieved through traditional breeding methods.”

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Asset Segmentation, Tokenization, And Blockchain Technology

– Contributed content –

21 May 2018. In terms of industries being able to survive, perhaps the notion of relying on the wealthy 1% of the world makes sense. They not only have a lot of capital, they also are generally people more seasoned with money. They’re calmer and able to see money as an object, therefore, they don’t attach emotions to their investment making them great clients. Survival is never the aim of an industry, thriving and advancing is, however. So would it be best to rely on just a small percentage of the population to do all the heavy lifting?

Of course not, because the more people there are ready to invest, the more chance there is expanding and success throughout the industry. Allowing as many investors as possible regardless of their capital seems like the only way for modern companies to achieve their grandiose goals. This is where blockchain technologies come in as they have the system of segmenting already figured out. The more opportunity you give to small investors, the more people are holding your entity upright. But is this all just theory or could this be the future of investing?

Opening new doors

Blockchain technology is like a slow rumbling avalanche. Economists and technology experts can see it coming but the vast majority of people are facing the other way. The mainstream knowledge of blockchaining is very limited which means traditional ways of investing seem to not only be the best option but the only option. Sooner or later the avalanche will sweep you up whether you’re prepared for it or not. Imagine for a second that you aren’t considered a wealthy investor. You don’t have money to throw around as you wish, but you have saved up enough to where you have a small amount of capital. Now, you don’t have enough to buy a house or an expensive car, but what if you could own a piece of a valuable property and performance car?

You’ve probably raised an eyebrow and asking yourself if that’s even possible. Take the new exciting business of Bitcar. Don’t have enough money to buy that exotic supercar you’ve always wanted? Well with Bitcar you can own a piece of a supercar, which comes in the form of asset tokenization giving your fractional ownership. The title of each asset is split up and each piece is assigned a token. The token value is pegged to the US dollar value of the asset on the market. If you wish to own all the tokens of an asset, you effectively own the title to the car. You can take the car you now own off the Bitcar platform and use it as you would a normal car or choose to still keep it on the platform. Since the hard asset price on the market can go up and down, tokens can end up making you money if you sell at the right time. In the meantime, you still have the right to take the car out for a spin since you own part of the title. Pretty awesome for those who can’t afford to outright buy an exotic car for themselves with cold hard cash.

Chopping up property

You’ll never look at a commercial office building the same ever again. Picture a 30-story building which has different investors for each floor. It’s an amazingly intriguing thought but it’s an actual reality. Giving normal everyday people access to a lucrative asset means that a property has a stable foundation of interested investors. Now if a property owner wants to garner as much attention and investment as possible, rather than going to a real estate agent, they would go to a blockchain platform. Real estate blockchain technology allows them to first register with the platform and then with a smart contract, segment their property. These segments will go through a financial institution that then offers them to the wider public. The public can buy the segments and enter into the tokenized economy of the blockchain platform. Their token represents a security i.e. the piece of the asset they bought.

Since the value of the property of which they partly own can go up or down, their token may end up being worth much more than what they paid for it. As with the principles of a blockchain, the exchange of ownership is done on the blockchain platform. The history of ownership and the smart contract openly states what the property consists of. The buying and selling is done in front of the entire community which keeps records of the transaction. There’s no need to involve a financial institution or government authority for them to give their approval. No need to sign a contract, you simply inherit the contract once the exchange has occurred. What this means for the wider public is that they have an increased chance of getting into real estate investments. If you don’t have enough capital to buy a commercial office or residential property, you can access parts of it through tokenization and blockchain trading.

 

Bar graph, arrow

(Gerd Altmann, Pixabay)

Would values go down?

To someone looking in from the outside, they could be forgiven for thinking that values of assets would go down thanks to the segmentation effect. It makes sense at first because surely an intact chocolate bar is worth more than one that has been broken up in the wrapper right? Assets have been almost exclusive to a certain part of the investment world. Usually, you would be expected to be somewhat wealthy so asset owners could rely on you to pass a credit score of their satisfaction. They want someone who is reliable and enough stomach to not get the jitters if their industry the asset was in were to experience a period of volatility. With more investors involved in the prosperity of an asset, this gives the asset more time and reliability to mature and increase in value. Whenever there are more people to prop up an asset, the less risk there is that having one or a few investors; it’s simply a numbers game.

Wouldn’t you love to say you own a piece of the title to a supercar? Not only can you take your exotic car for a spin but you stand to make a profit the more the market value of the car goes up. Tokenization in the real estate market has allowed asset exchanges to be faster and safer thanks to the blockchain technology platforms.

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Infographic – Graphene Investment in Decline

Investments in graphene start-ups

Investments in graphene start-ups, 2008 to 2017. Click on image for full-size view. (CB Insights)

19 May 2018. Almost from the day we started Science & Enterprise, we’ve reported on research and development on graphene, a material with many highly desired properties for a wide range of industries. Graphene is closely related to graphite like that used in pencils. The material is very light, strong, chemically stable, and can conduct both heat and electricity, with applications in electronics, energy, and health care. In 2010, two researchers at University of Manchester in the U.K. received the Nobel Prize in physics for their discoveries on graphene.

In the time we’ve reported on graphene, we also waited for meaningful commercialization of the technology. In a report this week, our friends at CB Insights show that the investment community is also waiting for graphene to reach a critical commercial mass, but their patience may be running out, the highlight of this weekend’s infographic.

As noted by CB Insights, venture investment in start-up enterprises developing graphene applications peaked in 2015, with more than $36 million placed in 11 deals, but since then has dropped off markedly. In 2017, start-ups working in graphene raised only 2.3 million, down from $17 million in 2016. The only bright spot in the report is the number of investment deals rose in 2017 to 8, from a near decade-low 2 deals in the previous year.  The CB Insights report shows as well a similar pattern for investments in carbon nanotube technologies.

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Five Things You Should Consider Outsourcing When Running a Research Lab

– Contributed content –

Research lab

(filexioncool, Pixabay)

19 May 2018. In case you operate in an industry that heavily relies on research and development, it is important that you keep your costs down and learn to delegate some of the tasks associated with running a research lab. From financial management to publication and information sharing, there are plenty of things you’d rather not do to focus on developing new patents and innovative solutions for your clients. Below you will find a few things you should consider outsourcing.

Apprenticeship management

When you run a research facility, you might be collaborating with local universities and colleges to share the facilities and knowledge. This is a great way of saving money and taking advantage of the latest technologies and the best talent. If you plan to employ apprentices from the university, it is important that you appoint a liaison officer who looks after the students and negotiates with the higher education institutions.

Equipment sourcing

You don’t want to search for the best lab equipment and safety clothing, as this takes too much time. You can get a company to do it for you. Simply create a list of the things you will need on a regular basis, and they will be delivering the tools and lab equipment on demand. You can save money and time by outsourcing procurement to an expert and specialized company. This will also prevent shortages that will result in delays.

Lab equipment

(Bobjgalindo, Wikimedia Commons)

Legal issues and patenting

You simply cannot fully focus on the legal side of the research when managing lab technicians and dealing with complicated projects. A specialist research legal firm will be able to register and trademark all your innovations and patents, so you are not wasting your efforts. Once your innovations are protected, you can sell them to other companies as well, so they can use it for their own projects.

Maintenance

You simply don’t want to pay high wages for your lab technicians to clean the equipment or carry out safety checks and calibration. The good news is that there  are plenty of great lab support companies that will take care of this task at an affordable price. Whether you need thermometer calibration or general maintenance and testing, you can find an expert company to take care of your needs.

Marketing your innovations

When you are focusing on finding new innovative technologies and solutions, you will have no time to market your intellectual property. You can improve the structure of your venture by creating a marketing plan collaborating with a company that knows your industry and your potential buyers. Even if your company doesn’t have a separate department for liaising with other industry players and marketing the latest inventions, an external company with experience in your field can make a huge difference when it comes to maximizing your return on investment.

It is important that you don’t spread yourself too thin when running a busy research and development facility. Do what you can do best, and outsource some of the specialist tasks that can help you achieve long term success.

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Virtual Biopsy in Development to Detect Melanoma

Sunset

(Alexas Fotos, Pixabay)

18 May 2018. An engineering professor in Colorado is developing a new process for diagnosing melanoma, an aggressive form of skin cancer that analyzes conditions in the skin without removing tissue samples. In April, Jesse Wilson, a researcher and engineering faculty member at Colorado State University in Fort Collins received a competitive grant from Melanoma Research Alliance to fund his work.

Wilson studies biomedical optics, particularly digital signal processing for diagnostics and pathology in cancer. In this new project, Wilson plans to apply advances in photonics to reveal key information in a person’s skin indicating the presence of melanoma cells. Detecting melanoma today usually requires taking a biopsy, a physical tissue sample of a person’s skin.

Melanoma is an aggressive type of skin cancer, which while not as common as basal cell and squamous cell skin cancers, is more likely to spread to other parts of the body. American Cancer Society expects more than 91,000 people in the U.S. to develop melanoma in 2016, leading to some 9,300 deaths. If melanoma is caught and treated early, before it spreads or metastasizes, the 5-year survival rate is 92 percent. After the cancer spreads to other parts of the body, however, the 5-year survival rate drops to 13 percent.

In principle, says Wilson, current high-powered and ultra-short pulse lasers, like those used in Lasik surgery, could provide images with precision and clarity needed for diagnosing skin cancers like melanoma. But the equipment is expensive and the lasers can be dangerous for patients. Instead, Wilson proposes enhancing current laser microscope technology with digital signal processing techniques and artificial intelligence algorithms. The result, he says, will be clear biopsy images that far exceed the quality of images now returned by laser microscopes cleared for diagnostics by FDA.

“Right now there are a handful of virtual biopsy tools available in the United States,” notes Wilson in a university statement, “but the devices are imperfect because they produce grainy images that bear little resemblance to a traditional biopsy.” The new technology, says Wilson, will make it possible to more easily screen patients for melanoma than taking a tissue biopsy, reducing the need for tissue biopsies only to cases where there’s a high likelihood of melanoma. Virtual biopsies would also provide surgeons with more precise boundaries of tumors, making melanoma resection surgery more precise.

And the technology would not be restricted only to humans. Wilson is collaborating with colleagues at Colorado State’s Flint Animal Cancer Center that provides cancer diagnostics and care for pets. The goal is to devise laser-based techniques for analyzing suspected growths on a dog’s skin that can be compared to traditional tissue biopsies in a clinical trial.

Wilson is one of 15 recipients of young investigator awards from the Melanoma Research Alliance that aim to attract early career scientists with new ideas in the field of melanoma. While the exact amount of Wilson’s award was not revealed, young investigator awardees are eligible for grants of $75,000 a year for 3 years, for a total of $225,000.

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Mobile Tech Helps Reduce Adverse Cancer Therapy Effects

Susan Peterson

Susan Peterson (M.D. Anderson Cancer Center)

18 May 2018. Mobile technology combined with sensor-connected home devices are shown in a clinical trial to help patients reduce adverse side effects from radiation therapy for head and neck cancer. Findings of the trial, led by a team from M.D. Anderson Cancer Center in Houston, part of the University of Texas system, will be presented on 2 June at the annual meeting of American Society of Clinical Oncology in Chicago.

The team led by M.D. Anderson behavioral scientist Susan Peterson is assessing a mobile technology platform called Cyberinfrastructure for comparative effectiveness research, or Cycore, that applies mobile and sensor technology to improve the delivery of cancer treatments. In this case, Peterson and colleagues studied use of Cycore among patients receiving radiation treatments for head and neck cancers. American Cancer Society estimates some 51,500 new cases of head and neck cancer will be diagnosed in the U.S. during 2018, leading to about 10,000 deaths. Treatments for these cancers often involve radiation, with chemotherapy and surgery, which in many cases result in oral mucositis, a condition making it painful to swallow, leading to dehydration among patients.

Cycore is a collaboration of M.D. Anderson with University of California in San Diego, Qualcomm Institute affiliated with UC-San Diego, and University of Alabama in Birmingham. The project is establishing a platform and methods for using mobile and sensor-connected technologies to collect real-time data from patients that provide their physicians with more timely reports on the health of their patients, and improve adherence to drugs and treatments.

In the clinical trial, the team enrolled 357 patients at M.D. Anderson with head and neck cancers, who were randomly assigned to equip their homes with Cycore technology as well as receive the standard care given patients, or receive the usual cancer care alone. Cycore-equipped homes had blood-pressure cuffs and weight scales with sensors connected via Bluetooth links to an in-home Wi-Fi network, and a mobile software app on a tablet. The tablet app then relayed the sensor data to a server at M.D. Anderson. Participants in the trial completed 28-item surveys by phone interview on cancer symptoms — including swallowing and chewing characteristic of head and neck cancer — as well as their overall health and quality of life. Data were collected at the start of their treatments, immediately after treatments, and 6 to 8 weeks following therapy.

The surveys asked patients to rate the severity of symptoms or pain on a scale of 0 to 10, with 10 being the most severe symptoms or pain. Participants in the Cycore and standard care groups rated their symptoms about the same at the beginning of treatments, but by the end of therapy, Cycore participants rated their symptoms, including symptoms specific to head and neck cancer, less severe than individuals in the standard care group. After 6 to 8 weeks following therapy, participants in the Cycore group continued to report less severe symptoms, including those specific to head and neck cancer, than participants receiving the usual care.

The study team was particularly encouraged by the high rates of participation and adherence to Cycore technology, with 85 percent agreeing to take part in the Cycore group and 80 percent sticking with the program. “These findings suggest that home monitoring and early intervention by physicians could potentially result in better outcomes for our patients,” says Peterson in an M.D. Anderson statement. “Less severe symptoms means patients may be tolerating their treatment better, and hopefully have better outcomes.”

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