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Pharma, Biotech Partner on Neuro Therapies in $1.1B Deal

Nerve cells illustration

(commonfund.nih.gov)

20 February 2018. Voyager Therapeutics, a developer of gene therapies for neurological disorders, is collaborating with drug maker AbbVie on treatments for diseases resulting from the build-up of damaging proteins in the brain, as in Alzheimer’s disease. The agreement with AbbVie, in Chicago, could bring the Cambridge, Massachusetts-based Voyager Therapeutics more than $1.1 billion if all aspects of the licensing deal are fulfilled.

Neuroscience is also one of AbbVie’s disease specialties, particularly therapies for degenerative disorders, such as Alzheimer’s disease. Voyager and AbbVie plan to collaborate on developing treatments to counteract the the damaging accumulation of tau proteins in the brain, a characteristic of Alzheimer’s disease. Tau proteins occur naturally and are found in abundance, where they stabilize and provide flexibility for nerve cells. In Alzheimer’s disease and related disorders, tau proteins accumulate in ways that destabilize and damage nerve cells, where the protein build-up is correlated with increasing severity of the disease and degeneration.

The two companies say their goal is to develop a one-time treatment with therapeutic antibodies, like those harnessing the immune system to treat cancer, and Voyager’s methods using benign viruses to deliver anti-tau antibodies to the brain. Voyager’s technology harnesses adeno-associated viruses to deliver healthy genetic material for expressing proteins missing from mutated or damaged genes causing inherited diseases. Adeno-associated viruses are benign, naturally occurring microbes that can infect cells, but do not integrate with the cell’s genome or cause disease, and generate a mild immune response.

In this case, adeno-associated viruses would deliver antibodies to the brain with genetic instructions to reduce tau proteins. This method, say the companies, seeks to overcome barriers that before prevented drugs in effective quantities from reaching nerve cells in the brain. “Voyager’s vectorized antibody platform,” says Jim Sullivan, AbbVie’s vice-president for drug discovery in a company statement, “presents an innovative approach to addressing challenges in treating neurological disorders associated with the administration of biologic therapies. This collaboration has the potential to address the needs of patients who live with conditions such as Alzheimer’s disease, progressive supranuclear palsy, and frontotemporal dementia.”

The agreement calls for Voyager Therapeutics to conduct preclinical research on synthetic antibodies delivered with adeno-associated viruses, from which AbbVie will select candidates for further development. Voyager will then develop each selected candidate through early-stage clinical trials. At that point, AbbVie will have the option of taking the therapy candidates through later-stage clinical trials and commercialization worldwide.

Under the deal, Voyager is receiving an initial fee of $69 million from AbbVie, and will be eligible for up to $155 million for its preclinical work and early-stage clinical trials. For the treatment candidates licensed for later-stage trials and commercialization, Voyager will be eligible for developmental and regulatory milestone payments of up to $895 million. Voyager will also be eligible for royalties on sales of products for neurodegenerative diseases from the collaboration, and the company can earn higher royalties, in exchange for taking on a share of costs for clinical trials.

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RNA Vaccine Shows Promise with Infant Viral Diseases

Cytomegalovirus infection

Cytomegalovirus infection (Yale Rosen, Flickr)

20 February 2018. A vaccine using synthetic RNA, with protein instructions transcribed from one’s genetic code, is shown in tests with lab animals to protect against infections from cytomegalovirus, a virus affecting infants and transplant recipients. Results of the study conducted by researchers with the biotechnology company Moderna Therapeutics in Cambridge, Massachusetts, appear in the 15 February issue of the journal Vaccine.

Cytomegalovirus, or CMV, is a virus in the herpes family found in large percentages of people, but adversely affecting smaller numbers of individuals. Centers for Disease Control and Prevention says nearly 1 in 3 children by age 5, and more than half of adults in the U.S. by age 40 are infected with CMV. In people with healthy immune systems, CMV does not cause illness, but in people with weakened immune systems, CMV infections can have serious consequences. Among those at risk are fetuses and newborns, who can develop congenital CMV, with symptoms including deafness, vision loss, and microcephaly like infants infected with the Zika virus. CMV is also the most frequent viral disease in transplant patients, but no vaccines protecting against CMV are yet approved.

Moderna develops therapeutic proteins with a technology that synthesizes messenger RNA, a nucleic acid with the genetic code from DNA used by cells to produce the amino acids in proteins for cellular functions. Moderna manipulates the coding region in the messenger RNA chemistry to provide instructions for cells to produce proteins with specific therapeutic properties. Those coding instructions are contained in a standard package that appears in most cases like natural RNA to avoid triggering an immune response, and reach the desired cells where the therapeutic protein is needed.

For protective vaccines, Moderna delivers messenger RNA with instructions for cells to produce proteins with enough resemblance to viruses to generate an immune response, but still safe for the recipient. In this case the company’s candidate vaccine, code-named mRNA-1647, is designed to produce glycoproteins — proteins with carbohydrates attached — in cells with characteristics of CMV like those found on the virus’s exterior. The vaccine also produces a complex of 5 proteins associated with CMV’s entry through skin and blood vessel cells.

Moderna tested mRNA-1647 in lab mice and monkeys, with the vaccine formulated into lipid, or natural body oil, nanoscale particles. The results show the vaccine produced in both mice and monkeys increases concentrations of antibodies, as measured by titers in their blood, that protect against CMV infections. In addition, the higher concentrations of antibodies remain in the animals for several months.

The company is also producing an associated vaccine that generates stronger responses with T-cells, a type of white blood cell in the immune system. This vaccine, also formulated as lipid nanoscale particles, seeks to active a protein known as pp65, also associated with CMV infections, and administered with the glycoprotein vaccine. In tests with lab mice, the combined vaccines produce higher concentrations of antibodies, but also generate strong T-cell responses.

While the paper gives results from a preclinical study of CMV vaccines, Moderna is already testing mRNA-1647 in an early-stage clinical trial. That study is looking primarily at the vaccine’s safety and immune responses against a placebo, among 209 healthy individuals at 3 sites in the U.S.

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Embracing Technology for Better Business Efficiency

– Contributed content 

Man, woman, laptop

(Photo by rawpixel.com on Unsplash)

19 February 2018. Technology is becoming a more common aspect of every workplace, and it is not just computers and emails which are now the norm in every office across the world. Finding technology that works to make your office more efficient in all aspects, from trading to productivity to saving money is essential towards achieving further growth in your company.

Saving time

Every business wished that it could do twice of the work in half the time. At the minute, this isn’t yet a reality. However, every day we edge closer and closer to making this wish true for every company in the world. Like computers and word processing made completing reports and documents that much quicker, the same can be said for platforms that increase the rate at which that complicated work is completed.

You might feel overwhelmed by the sheer amount of aspects that you need to keep up with for it to be beneficial to you and your business. However, there are platforms, such as AlgoTerminal, that have been designed to save you time and money by completing tasks that would take a human days and perhaps weeks in just a matter of minutes.

Saving money

Saving money is something that is always brought up when attending budget and projection meetings and there is always something that a company can cut back on if it wants to save money. Finding technology that can help save your company money can range from cloud-based storage to security and everything in between.

More and more people are embracing the work-from-home culture that many companies now offer. In the past, they would need to come into the office every day to complete their work. However, using cloud storage means their documents can be accessed anywhere in the world and can save money on office space.

Furthermore, in the event of a security breach, you might be worried that you lose years worth of data and perhaps time. Therefore, investing in a reliable and robust security system will allow little time lost following the attack and allow you to get back on track.

Productive tech

You want your business to be as productive as possible. The phenomenon of absenteeism, as well as presenteeism, is rife in many workplaces as the employees feel overworked and run the risk of suffering from burnout.

Taking steps towards improving their productivity, whether it be through platforms that help them complete more tasks in a single workday, or looking at ways to improve office atmosphere by switching to energy-efficient lighting and other sustainable solutions will make the office a more productive place to be. A happy employee is a hard-working one, and the technology you seek out does not necessarily need to be business based. Your workers are human, and so adhering to their basic human needs is something that will save you money in the long run.

Better efficiency

Having a more efficient workplace is what every company dreams of but too often relies on the old ways of motivation and team-building. While these still work to a degree, it will also pay to look towards the advancements available to you in the form of technology, which when embraced and used properly can produce results that might not have been expected or possible had you ignored them.

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Scenes from the AAAS Annual Meeting

Child with safety gloves

It’s never too soon to learn lab safety. Family Science Days at the AAAS annual meeting in Austin, Texas (A. Kotok)

18 February 2018. Science & Enterprise is reporting this weekend from some of the key sessions at the American Association for the Advancement of Science annual meeting in Austin, Texas. But there’s more going on at the meeting than papers and presentations, including Family Science Days, always a big hit with kids of all ages. Of particular note, AAAS is encouraging researchers to better explain their science to audiences outside the lab, including help with a professional head shot photo for their resumes and web pages.

Science & Enterprise returns to its regular posting on Tuesday, 20 February.

 

Shooting video

Share Your Science, a program for scientists to prepare and record 2-minute pitches about their work. (A. Kotok)

 

Make up for photos

You need to look your best in a photo on your resume or web page. AAAS expects to shoot some 120 professional photos at this year’s meeting. (A. Kotok)

 

Pixel Profundo app

Family Science Days: Pixel Profundo is an augmented reality app that teaches about science and nature around Austin, Texas. (A. Kotok)

 

Iowa Neuroscience Institute

Family Science Days: The University of Iowa Neuroscience Institute demonstrates involuntary movements in the nervous system. (A. Kotok)

 

Rose Research Group

Family Science Days: The Rose Research Group at the University of Texas chemistry department shows how hydrogen is split from water. (A. Kotok)

 

Building circuits

Family Science Days: Thinkery, a children’s science museum in Austin helps kids build circuits. (A. Kotok)

 

Pipetting

Family Science Days: National Human Genome Research Institute helps kids learn the fine points of operating a pipette. (A. Kotok)

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Gut Tissue From Stem Cells Simulated on Organ Chips

Clive Svendsen

Clive Svendsen speaking at the AAAS annual meeting, 17 February 2018 (A. Kotok)

17 February 2018. Researchers created working human gut tissue cells derived from stem cells, grown on plastic chips simulating intestinal diseases, as a tool for testing effectiveness and safety of treatments before given to patients. Speakers from Cedars-Sinai Medical Center and the company Emulate Inc. described their findings today at the annual meeting of American Association for Advancement of Science, or AAAS, in Austin, Texas.

In addition, Cedars-Sinai, in Los Angeles, plans to advance the organ-on-a-chip technology into its precision medicine program, to be called Patient-on-a-Chip, for identifying treatments reflecting an individual’s condition and molecular make-up. Science and Enterprise learned Cedars-Sinai and Emulate Inc., in Boston, expect to announce the program next week.

Organs-on-chips, as the name implies, are small flexible polymer plastic devices with fine channels etched in the surface or drilled through, lined with live tissue and cells, and designed to simulate the workings of human organs. As explained by Geraldine Hamilton, president of Emulate Inc. at the AAAS meeting, the 3-D tissues on the devices make it possible to predict the behavior of human organs better than animal models like mice, and cells growing in lab cultures. Organs-on-chips, said Hamilton, simulate the flow, dynamics, and environment of complex systems in organs, enabling the “control of biology, but also the physics that controls the biology.”

Clive Svendsen, one of the leaders of the Cedars-Sinai initiative, outlined the role of human induced pluripotent stem cells — also known as adult stem cells, derived from existing tissue rather than embryos — in creating organ-on-chip devices for precision medicine. Svendsen, with colleagues at Cedars-Sinai and Emulate Inc., created an intestine chip with stem cells to reflect the unique genomics of the person supplying the stem cells, first producing organoids, then growing 3-D intestinal tissue.

The team used the intestine chips to simulate inflammatory bowel disease, a gastrointestinal disorder. A paper published in December 2017 describes the process, where an enzyme associated with the disorder produce characteristic reactions of inflammatory bowel disease in the epithelial cells lining the intestine chip. In addition, the reactions of these cells in the intestine chips better simulate the disease than comparable cells in organoids alone.

Lung-on-chip

Lung-on-chip device (Emulate Inc.)

Brain, lung, liver, eyes, blood clots

“We can produce an unlimited number of copies of this tissue and use them to evaluate potential therapies,” says Svendsen in a joint Cedars-Sinai and Emulate Inc. statement. “This is an important advance in personalized medicine.” Cedars-Sinai plans to apply intestine chips as part of its precision medicine program, beginning with early-onset inflammatory bowel disease, a form of the disorder affecting young children. Svendsen’s lab is also developing a chip simulating the blood-brain barrier for research on neurodegenerative disorders including amyotrophic lateral sclerosis, or ALS, and Parkinson’s disease.

Hamilton says Emulate Inc., a spin-off enterprise from the Wyss Institute at Harvard University, is developing airway and lung chips to test for respiratory disorders, and liver chips that can help find toxicities in drugs more reliably than lab animals. As reported by Science & Enterprise, Emulate and the Food and Drug Administration are also assessing the ability of organs-on-chips to fulfill regulatory needs for testing drugs, as well as food, dietary supplements, and cosmetics.

Dan Huh, a bioengineering professor at University of Pennsylvania in Philadelphia and the AAAS panel’s moderator, described his lab’s work developing a human eye on a chip that not only the mimics the eye’s physiology, but simulates its blinking actions as well. Huh’s group is also working with NASA on testing immune system cells in microgravity, a critical concern for extended space travel.

Robert Urban, head of Johnson & Johnson Innovation in Cambridge, Massachusetts, described for the AAAS audience development of a chip device that helped resolve problems with a synthetic antibody for treating systemic lupus erythematosus, commonly known as lupus, an autoimmune disorder. Working with Emulate Inc., an organ chip was able to identify the mechanism forming blood clots caused by the antibody, which were not revealed in preclinical tests with animals.

More from Science and Enterprise:

Disclosure: The author owns shares in Johnson & Johnson.

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Alexa, How Will Amazon Echo Affect My Business?

– Contributed content –

Amazon Echo

Amazon Echo (Rick Turoczy, Flickr)

16 February 2018. “It may change the entire company as a whole” should be her response. An Amazon Echo looks like a fun toy that people can use at home. It’s Siri on steroids, a product indicative of the lazy and needy society we live in today. But, before you get on your high horse, it’s important to note the Internet of Things.

What on earth is the IoT, you ask? Well, it’s a digital presence connecting everyday household items and the internet. Tech nerds have been warning about the ‘apocalypse’ for years and it is finally here thanks to Alexa. Now, syncing devices and turning a house into a smart home is a piece of cake. The same goes for businesses, too.

It isn’t simple to see how this may impact your company, but delve a little deeper and you’ll spot the answers. You’ll see estimates of connected devices by 2020 are predicted close to 30 million. And, this figure suggests the industry could be worth billions within five to ten years. The Internet of Things is here and it’s real, and this is how it will change businesses for better or for worse.

Uber qualified

First thing’s first – the Internet of Things is a new market that is ripe for growth. Like all of these sectors before it, that means there is a huge opportunity for businesses. Starting on the ground floor is often the only way to transform from an SME into an industry leader. Making the switch is never easy, and it won’t get easier without the help of quality, qualified workers. Employees can see the potential pros and cons and use their knowledge to sidestep the major issues. For example, IT technicians constantly analyze servers and check for bugs and hackers. And, everyone from a marketer to a salesperson can do the same with training and further education. What’s music to the ears of bosses is a non-intrusive MBA management online course. Thanks to the World Wide Web, the whole office can learn new skills via a computer after their shift ends.

Size & cost management matter

Every business owner would love to hire as many employees as possible and enter them into training courses. The problem is money. Seminars and lectures aren’t cheap and small companies usually don’t have the funds. So, they decide to hold off investing and continue as normal. The issue from a technological point of view is that bosses can’t afford to procrastinate. Without extra skills, the workforce won’t be able to adapt to a process that is about to take over. As a result, the firm could go bust. Say you do find the finance – what happens next? Well, the skill base gets a boost, but so does the number of people on the payroll as new additions will be inevitable. Taking up space, this fresh influx of people could force the business to move premises. Expanding too quickly is a sure-fire way to bite off more than you can chew and choke. Sorry to be blunt, but it’s the truth.

Fluid data

Big data is a buzz phrase these days as marketers understand the link between info and revenue. In layman’s terms, the more of it a company has, the higher the chances are of making a conversion. As long the people in charge know how to break it down, the business should be able to tweak and repackage to sell more units. Getting hold of this data is difficult in a day and age where privacy is a major talking point. Ask a consumer to reveal their home address and it could put them off making a purchase. What’s great about software such as Alexa and Siri is that people tend to be more comfortable. It’s not that they don’t understand they store data; it’s that they don’t care. The average user would rather ask for info and share it with companies than open a new tab on a mobile device. With synced homes, the chances are you’ll have extra data to make to influence the buying cycle.

1984 backlash

One thing companies have to be aware of is the way customers perceive data ‘leaks.’ If they are unaware the info is being used and shared, they won’t be happy. It doesn’t matter that it was stated in the terms and conditions because it’s still a personal breach. The majority of people think organizations should do more to promote the fact they are studying sensitive data anyway. So, public opinion isn’t and won’t be in your favor. Shoppers who believe your business is part of a ‘1984’, Illuminati-style conspiracy will vote with their feet and never come back. Once the word gets around, the trust will start to erode and that is fatal. The IoT makes collecting data simple, but it can come at a cost which is why it’s vital to be transparent. Stating how the product or service deals with sensitive info is an excellent way to maintain your base’s loyalty.

Package warehouse

(Falco, Pixabay)

Eyes on the prize

Businesses that keep their shipping in-house are going to love smart technology because it’s all-seeing. Just set up the software and input the bar codes and nothing should go missing. And, if it does, you can track it down and rectify a mistake with minimal fuss and effort. A feature like this is essential for two reasons. The first is customer service. In a world where consumerism is the king, shoppers want their goods on time and even quicker if possible. At the moment, a lost parcel can add days and weeks to the delivery process, which results in an unsatisfactory level of service. Package trackers will slash the delay times and limit the damage. Secondly, shipping errors tend to cost companies money and lots of it. Although software can be expensive, its ability to solve problems should cut costs in the long-term.

Excuse me?

Companies shouldn’t make promises because there’s no need to give your word in the first place. Guarantees are for suckers. Still, it may not be the fault of the business even when a pledge goes wrong. For instance, the outsourcer may make a mistake which costs them time and reflects on the overall service. It isn’t rare for couriers to waste time or deliver to the wrong address. Unfortunately, tracking software doesn’t provide the firm with a contingency plan. At least with the old system, line managers could blame it on the servers before finding out what was wrong. Now that technology is almost foolproof, businesses don’t have a backup. Customers will expect the service to be infallible, which is a bad thing because errors are a way of life. Sorry to say it, but the IoT could increase expectation and put the company under the microscope.

Houston, do we have a problem?

Syncing an office allows employees to work from home. Modern businesses are finding out that this is a good thing because it cuts costs on things such as overheads. Plus, home-based work increases the balance between life and the office and makes employees feel independent and free. It is worth noting those benefits are for the most part. On the flip side, people have been known to take advantage of working from home by doing the bare minimum and skipping their duties. The result is a decrease in productivity, and that is terrible for revenue and profits. Alexa giveth with one hand and taketh away with the other.

How do you now feel about Alexa? Is she going to be a plus or a minus?

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NIH Exec: Research Offers Opioid Crisis Solutions

Nora Volkow

Nora Volkow at the AAAS annual meeting, 16 February 2018 (A. Kotok)

16 February 2018. The director of the National Institute on Drug Abuse says recent research in neuroscience and pharmacology reveals possible pathways out of the current epidemic of opioid addiction and overdose deaths. Nora Volkow, director of NIDA, part of National Institutes of Health, since 2003 presented her remarks today during the 2018 American Association for the Advancement of Science (AAAS) annual meeting in Austin, Texas.

Volkow outlined the distressing and startling statistics on opioid addiction, showing the number of opioid-related overdose deaths increasing rapidly in recent years. In 2016, according to data from Centers for Disease Control and Prevention, some 64,000 people in the U.S. died from opioid overdoses, of which more than 20,000 of those fatalities involved the synthetic opioid drug fentanyl. The problem is also now nationwide, where in 1999, high rates of overdose deaths occurred in isolated pockets of the U.S., such as the Appalachian region and New Mexico.

The problem of opioid addiction, says Volkow is closely interrelated with the management of pain. Too many medical practitioners, she notes, became overconfident that medications were safe. But as negative consequences of opioids began piling up, she notes, it became clear “opioids are not a panacea for pain, particularly chronic pain.”

Studies of opioids’ activity in the brain point out the drugs’ potential dangers. Opioids target mu opioid receptors in the brain that signal neurons reacting to pain, but also to pleasure and rewards. Regions of the brain dealing with pain are found near the nucleus accumbens, the site that regulates reward behavior and involved in reinforcing addictions.

While control of pain may have instigated the opioid crisis, says Volkow, illicit drugs are now sustaining and exacerbating the problem. One of those drugs is heroin, for which overdoses were relatively stable until 2010. Pure heroin from Mexico, however, is now less expensive that prescription opioid drugs, notes Volkow, enabling people addicted to prescription opioids  to maintain their habits at lower cost. Some 70 percent of people addicted to heroin, adds Volkow, started with prescription pain medications. And because of fentanyl’s potency — some 500 times more than heroin — it is easy to hide and transport in small quantities.

Routes out of crisis

Volkow discussed findings from research on current drugs to treat opioid addiction that show promise in breaking the addiction syndrome. Buprenorphine is a partial stimulator of opioid receptors, which when used as part of a treatment program, can help reduce cravings and withdrawal symptoms in people with opioid addictions, and in turn reduce their use of addicting opioids. Natrexone completely blocks the rewarding effects of opioids, and is also used as part of treatment programs when people with addictions can first fully withdraw from opioids.

Studies of these drugs, says Volkow, have encouraging results. Findings from research among people visiting community health centers, admitted to emergency rooms, or in the criminal justice system show simple interventions can reduce overdose deaths, criminal activity, and the spread of infectious diseases. The problem with these medication-assisted therapies is they’re underused, often because of the stigma in admitting an addiction.

Other treatments in development, notes Volkow, are addressing some of these complicating issues. Extended release forms of buprenorphine and natrexone, for example can help ease the problem of adherence to daily drugs. In addition, biologic therapies, such as vaccines, are being developed to produce antibodies that invoke the immune system to prevent fentanyl from getting into the brain. Another promising approach is non-pharmaceutical treatments, such as neurostimulation, to relieve pain.

In response to a question from Science & Enterprise, Volkow says actions by some states to cut back or restrict access to Medicaid may not directly affect treatment for opioid addiction. The more fundamental problem, Volkow notes, is gaining any reimbursement for opioid addiction therapies, from commercial insurance plans or Medicaid, forcing people with addictions to completely fund their treatments.

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Cancer Analytics Company Acquired in $1.9B Deal

Genomics graphic

(National Human Genome Research Institute, NIH)

16 February 2018. The global pharmaceutical company Roche is purchasing the cancer data management and analytics enterprise Flatiron Health in New York for $1.9 billion. The acquisition is expected to to boost Roche’s capabilities in precision medicine, where cancer treatments are guided by the patient’s molecular make-up as much as the type of the cancer.

Flatiron Health provides data analytics for cancer research and therapeutics that the company says delve deeper into clinical experiences than most other systems based largely on data from insurance claims. Among the company’s offerings is OncoCloud, a cloud-based electronic health database designed for data related to cancer, that includes an electronic health record created for cancer patient data with analytics and billing modules. The service also includes a portal for patient access.

Flatiron says 265 community clinics and academic health centers provide electronic health records for its database. Access to these records, says the company makes it possible to perform more detailed analysis over time, linking patients’ outcomes to genomics, an essential requirement for precision medicine. In addition, says Flatiron, its systems can abstract unstructured data, such as doctors’ notes, using machine-learning algorithms. FDA collaborated with Flatiron on a review of cancer immunotherapies, making use of the company’s store of real-world data, in a study published in January.

Under the agreement, Roche is acquiring Flatiron for $1.9 billion; the company already held a 12.6 percent equity stake in the company. However, Flatiron will continue to operate largely as before, maintaining its partnerships with other companies in the industry. The companies underscore that they will maintain the protection of Flatiron’s patient data.

Daniel O’Day, CEO of Roche, says in a joint statement, “This is an important step in our personalized healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments.” As reported in Science & Enterprise in 2015, Roche also acquired a majority equity stake in the cancer genetics company Foundation Medicine, in a deal valued at $1.2 billion. Foundation Medicine provides a personalized genomics profile of patients’ solid-tumor and blood-related cancers.

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Going to Austin, City with No Limits

Texas State History Museum

Texas State History Museum in Austin (A. Kotok)

14 February 2018. Science & Enterprise is headed to Austin, Texas to cover the annual meeting of American Association for the Advancement of Science, or AAAS, and we will report from the meeting from Friday through Sunday, 16 to 18 February. As a result we will not be posting any stories tomorrow, 15 February or next Monday, 19 February.

Austin is known for a lot of things, including its iconic slogan, Keep Austin Weird. Another is the super country/rock music show on public television in the U.S., Austin City Limits. Here’s a video from the show’s 40th anniversary telecast with an incredible all-star lineup. Enjoy.

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FDA Clears First Blood Test for Concussions

Rugby scrum

(Skeeze, Pixabay)

14 February 2018. The Food and Drug Administration authorized for marketing in the U.S. a blood test that screens for chemical indicators in the blood for concussions, a form of traumatic brain injury. The agency says the test made by Banyan Biomarkers Inc. in San Diego, is the first of its kind cleared to screen for concussions.

Traumatic brain injuries result from blows to the head, including those from contact sports, or penetrations of the skull that disrupt normal brain functions. Centers for Disease Control and Prevention says traumatic brain injuries contribute to 30 percent of all deaths from injuries, which for survivors can lead to disruptions in thinking, memory, movement, sensations, or emotional functions. CDC estimates in 2013, traumatic brain injuries accounted for 2.8 million emergency room visits, hospitalizations, and deaths.

Concussion is the term used for milder traumatic brain injuries, resulting in a brief change in mental status or consciousness, and according to Banyan Biomarkers, account for nearly all (95%) of  traumatic brain injury cases. Most concussions are screened today with the Glascow Coma Scale, a written scale of items that evaluates an individuals level of consciousness after a suspected brain injury, covering eye movements, verbal responses, and motor responses. If a person’s score on the scale exceeds a designated threshold, a computed tomography or CT scan of the head is requested to detect brain lesions or tissue damage.

Most concussions, however, do not result in damage to brain tissue, thus returning negative CT scan results. The Banyan Brain Trauma Indicator, says the company, is designed to provide an objective and less expensive alternative to CT scans. The test looks for the presence of 2 brain-specific proteins in a person’s blood sample: ubiquitin c-terminal hydrolase-L1 and glial fibrillary acidic protein. Both proteins are found in the brain, but when damage to the brain occurs, can spill out into the blood stream. The test is administered within 12 hours of a suspected concussion, with results returned in 3 to 4 hours.

FDA based its clearance of the test on a clinical trial completed in 2017 with 2,011 participants in the U.S. and Europe suspected of having a concussion. The study, co-sponsored by the U.S. Department of Defense, aimed to determine the value of the Banyan blood test as a way to more accurately determine the need for CT scans. The results show positive results on the Banyan test accurately predict the presence of brain tissue damage in CT scans 98 percent of the time, while negative results forecast the lack of brain lesions in more than 99 percent of cases.

The agency says it reviewed Banyan’s application in less than 6 months, as part of FDA’s Expedited Access Pathway Program, created by Congress in 2016 under the 21st Century Cures Act. One of the benefits of the Banyan test, noted in the agency announcement, is a reduced need for CT scans, which addresses another FDA priority, preventing unnecessary neuroimaging and associated radiation exposure to patients. “Today’s action,” says FDA Commissioner Scott Gottlieb, “supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose.”

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