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Science and Enterprise is an online news service created for researchers, administrators, business people, government officials, and observers interested in what it takes to convert scientific knowledge into marketable products and services. On the site’s posts and pages, you can find news about finance, intellectual property, regulations, and employment, among other topics.
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.
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.
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.
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.
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.
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?
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.
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.
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.
Austin City Limits Celebrates 40 Years "Not Fade Away" - YouTube
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.”
Graphene in the image of the Rice University owl mascot produced in fabric (Jeff Fitlow, Rice University)
14 February 2018. A chemistry lab at Rice University devised a process for producing graphene, a material that conducts electricity, in materials containing carbon, including fabrics and even food. The process, with applications in a wide range of industries, is described in yesterday’s issue of the journal ACS Nano (paid subscription required).
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, strong, chemically stable, and can conduct both heat and electricity, with applications in electronics, energy, manufacturing, distribution, and health care.
The lab of Rice chemistry professor James Tour in Houston studies the generation of graphene from a variety of sources. The lab’s process employs lasers delivered in multiple beams for disrupting carbon-based materials to produce graphene directly on its surface. This process, called laser-induced graphene, generates a form of graphene made of interconnected nanoscale flakes, rather than the elegant atomic hexagons in pure graphene. But what laser-induced graphene may lack in elegance, it makes up in economics. It produces graphene at room temperature and ambient conditions, rather than high temperatures in a carefully controlled atmosphere.
As Tour explains in a university statement, the process produces laser-induced graphene, or LIG, in 2 steps. “First, the laser photothermally converts the target surface into amorphous carbon,” says Tour. “Then on subsequent passes of the laser, the selective absorption of infrared light turns the amorphous carbon into LIG.”
As the new study shows, graphene can also be produced on a range of materials containing carbon. In an earlier study, reported in Science & Enterprise, Tour and colleagues produced graphene on polymide plastic film, where sending an electric current through the graphene produced hydrogen peroxide able to kill resistant bacteria found in hospitals and some public water systems.
In the new study, the Rice team, with associates from Ben-Gurion University of the Negev in Israel, extended the process to several other common materials, and simplified the technique to produce multiple beams in a single pass of the laser head. The researchers demonstrated the process on fabrics, wood, cardboard, and even food, producing graphene patterns including the Rice University logo and mascot. The materials used by the researchers were all high in lignin, an organic polymer that forms rigid cell walls in many plants, and thus found in wood, cork, coconut shells, and potato skins.
But beyond images, the graphene burned into these materials can also conduct an electric current, making it possible to embed circuits into common objects. An immediate application could be replacing quick-response or radio-frequency ID (RFID) tags now added to items, with graphene circuits burned into the materials. “Perhaps all food will have a tiny RFID tag,” says Tour, “that gives you information about where it’s been, how long it’s been stored, its country and city of origin, and the path it took to get to your table.”
Another application is sensors to detect pathogens in food. “They could light up and give you a signal that you don’t want to eat this,” notes Tour. “All that could be placed not on a separate tag on the food, but on the food itself.”
Tour and graduate student Yieu Chyan, the paper’s first author, tell more about the process in the following video.
Graphene on toast, clothing and cardboard has tasty potential - YouTube
U.S. Patent and Trademark Office in Alexandria, Virginia (A. Kotok)
13 February 2018. U.S. patents were awarded to a biotechnology company developing therapies using the genomic editing process known as Crispr to create immune system cells with proteins for attacking cancer cells. Patents numbered 9,855,297 and 9,890,393 were awarded on 2 January and today respectively, by the U.S. Patent and Trademark Office to 3 inventors, and assigned to Cellectis, based in New York and Paris.
Cellectis develops cancer treatments that harness the immune system by breaking down defenses tumors create to prevent the body’s immune system from fighting the disease. The company’s platform builds on recent developments that take T-cells, white blood cells from the immune system, and reprogram the cells through genetic engineering to find and kill cancer cells. The engineered T-cells become hunter cells, containing proteins known as chimeric antigen receptors that act like antibodies. These modified chimeric antigen receptor or CAR T-cells are infused into the patient, seeking out and binding to proteins associated with the cancer.
Most current CAR T-cell methods genetically engineer a patient’s own T-cells, then re-infuse the altered T-cells back into the individual. Cellectis’s process is designed to produce off-the-shelf CAR T-cell treatments, it calls Universal CAR T-cells, or UCARTs. These treatments use T-cells from healthy donors, rather than a patient’s own T-cells, then are genetically engineered to match the attributes of specific cancer types.
Both patents list as inventors Cellectis executives Philippe Duchateau, the company’s chief scientist, with CEO André Choulika, and early discovery director Laurent Poirot. And both patents cover the use of the genomic editing technique Crispr, for clustered regularly interspaced short palindromic repeats. The technique is based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr employs enzymes that cleave DNA strands at the desired points, with Crispr-associated protein 9, or Cas9, the enzyme used most often.
The earlier patent, dated 2 January, covers Crispr-Cas9 editing of T-cells, where messenger RNA guides Cas9 enzymes to at least one target in the T-cell genome. At that point Cas9 edits the T-cell genome at the target site, allowing for production of modified T-cells with the desired properties for immunotherapies. The 13 February patent also covers Crispr editing of T-cells, but allows for variations from single edits, including targeting 2 places in the DNA simultaneously, and delivering an inactive enzyme to the target site, then activating the edit inside the T-cell.
Cellectis applies its UCART technology mainly to blood-related cancers. In December 2017, the company reported initial findings from early-stage clinical trials of UCART cells in patients with B-cell acute lymphoblastic leukemia, conducted with other pharmaceutical companies. In the study of adults, 5 of 7 participants with relapsed or stubborn disease achieved molecular remission of the leukemia, where few cancer cells remain, after 28 days. A similar test with children show all 5 participants achieved molecular remission of their disease.
The clinical studies reported few safety problems with the UCART treatments, but that was not always the case. As reported in Science & Enterprise in September 2017, both trials were stopped by FDA when a patient died from cytokine-release syndrome, a complex of immune-system reactions to immunotherapies that worsened with complications, and who later did not respond to treatment. FDA lifted the clinical hold in November 2017, allowing the trials to continue.
13 February 2018. A clinical trial testing a common virus modified to generate a specific immune response dramatically reduced deadly brain tumors in a small group of patients and extended their survival for years, but most other patients had only limited success. Results of the trial by researchers at MD Anderson Cancer Center in Houston, part of the University of Texas system, appear in yesterday’s issue of Journal of Clinical Oncology (paid subscription required).
The team led by MD Anderson neurosurgeon Frederick Lang is seeking effective and reliable treatments for glioblastoma, an aggressive brain cancer that affects astrocyte or glial cells supporting neurons or nerve cells in the brain. Glioblastoma is often difficult to treat, where usually the best hope is to slow progression of the disease with radiation or chemotherapy. The cancer generally grows and spreads quickly, often resulting death within 15 months of diagnosis. American Association of Neurological Surgeons estimates glioblastoma occurs in 2 to 3 out of 100,000 adults per year, and accounts for 52 percent of all primary brain tumors.
Lang, along with neuro-oncology colleagues Juan Fueyo and Candelaria Gomez-Manzano, are developing a therapy that enlists the immune system to fight glioblastoma. Their treatment uses a genetically modified adenovirus, a type of virus benign to most people, but may cause the common cold and other viral diseases. In this case, the engineered adenovirus, code-named DNX-2401, is made to attack glioblastoma cells both directly and with the immune system.
“We designed DNX-2401 to specifically infect cancer cells,” says Fueyo in an MD Anderson statement, “replicate inside those cells to kill them, and spread from cell to cell in a destructive wave throughout the tumor.” The authors say preclinical studies show their approach could work with this type of brain cancer, with the clinical study its first test in humans.
The clinical trial recruited 37 patients with glioblastoma to test the safety and response of tumor cells to DNX-2401. Of the 37 participants, 25 received a single injection of DNX-2401 by catheter into their tumors at various dosage levels, while the other 12 patients received a DNX-2401 injection, followed by surgical removal of the tumor 2 weeks later to study the therapy’s mechanism of action in the brain. The primary measure of efficacy in the trial was reduction of tumor size.
The findings show dramatic outcomes for some patients, but only limited results for most. Of the 25 participants receiving DNX-2401 injections, 5 of the patients survived for more than 3 years. In addition, 3 of those patients showed 95 percent or more reduction in tumor size. “In the case of these long-term complete responders,” says Gomez-Manzano, “the virus breaks the tumor’s shield against immune response by killing cells, creating multiple antigen targets for the immune system. These tumors are then completely destroyed.”
After 3 years, however, beneficial effects of the treatments appear to wear off. The researchers say all 3 of the longer-term survivors experienced recurrences of cancer that proved fatal. Two of the survivors developed gliosarcoma, a different type of brain cancer. All 3 of the long-term survivors lived for nearly 5 years after their treatments.
Of the remaining patients, 18 experienced some reduction in their brain tumors, with a median overall survival time of 9.5 months. Among the 12 patients receiving DNX-2401 to study its activity in the brain, the authors say the virus replicates and spreads within the tumors as designed. In addition, the researchers report little toxicity and low-grade reactions to the treatments among 2 participants.
The trial’s results indicate the team has more work to expand the effectiveness of DNX-2401 to a larger percentage of glioblastoma patients. The researchers are studying the addition of new factors to the treatments to cover a broader range of people with the disease.
Fueyo and Gomez-Candelaria founded the company DNAtrix Inc. in Houston to take DNX-2401 to market. The company licenses the rights to the intellectual property owned by MD Anderson, with MD Anderson also holding an equity stake in the company. The company plans to further develop DNX-2401 as a treatment for solid tumor and blood-related cancers, both alone and with other therapies.
12 February 2018. A start-up company spun-off from Washington University in St. Louis was awarded a grant to advance an augmented reality system that displays an interactive hologram of a patient’s heart, to simplify cardiac procedures. SentiAR Inc. in St. Louis, formed just last year, is receiving the first installment of a planned $2.2 million in funding from National Heart, Lung, and Blood Institute, part of National Institutes of Health.
SentiAR’s software is designed to display a three-dimensional image of the patient’s heart portrayed on an augmented reality headset. Through the headset, the surgeon can view the heart, constructed with images from computed tomography or CT and MRI scans, as well as mapping data from catheters used in cardiac procedures. The first application of the system is arrhythmia, defined as any change from the normal sequence of electrical impulses regulating heart beats. Heart rhythm disorders prevent the heart from pumping adequate supplies of blood throughout the body, and can lead to blood clots, strokes, or damage to other organs.
The SentiAR system displays the heart hologram at eye level, without impairing the surgeon’s normal field of view during the procedure. The system, using Microsoft’s HoloLens platform, allows the patient’s hologram image to be manipulated with hand gestures, as well as expanded, rotated, entered, and measured as needed. The holograms can also be shared with other clinicians wearing headsets in the operating room.
SentiAR bases its technology on research conducted at Washington University by pediatric cardiologist Jennifer Silva and biomedical engineering professor Jonathan Silva, whose lab studies computational models to represent the various interacting scales of the heart’s electrical control system. The lab’s research aims to connect these scales and better understand their interactions to provide new therapeutic targets for patients with arrhythmia and other cardiac disorders.
The NIH grant, provided under the agency’s Small Business Innovation Research, or SBIR, program, is expected to deliver an augmented-reality/hologram system that can simplify ablation procedures to correct arrhythmias. These procedures use a catheter to deliver heat to destroy a small number of heart cells suspected of causing the irregular heart beat. While these procedures are relatively common — the company says some 1 million ablations occur each year — they’re still complex and can pose risks for patients. The SentiAR system aims to provide better real-time data about the patient’s heart to simplify these procedures for the surgeon.
SBIR funding for SentiAR is expected to total $2.2 million. The first installment of $223,532 covers the first 6 months of the project, through July 2018. Further funding, according to statement by SentiAR and BioGenerator, a biomedical business incubator in St. Louis supporting SentiAR, is based on achieving designated milestones. SentiAR already received $1.1 million in seed funds, co-led by BioGenerator that provided $400,000 of that amount.
“By improving the visualization of this information and empowering the physician with direct control of the model,” says co-founder and chief medical officer Jennifer Silva in the SentiAR-BioGenerator statement, “we will make these procedures both simpler and safer. Knowing that our peers – cardiologists and engineers – see the value of our solution and the potential impact it will have for both patients and practitioners is tremendous validation for SentiAR’s model.”
12 February 2018. A report by a biotechnology industry organization says development efforts and financing for new drugs to treat pain and addiction are falling behind the health and safety needs of society. The Biotechnology Innovation Organization or BIO released its report, “The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapeutics,” today.
BIO’s report is motivated in part by the continuing crisis in the U.S. in opioid addiction. The problem is intertwined with relief and management of pain, for which opioid drugs are usually prescribed. Opioids work by reducing the intensity of pain signals to the brain, particularly regions of the brain controlling emotion, which reduces effects of the pain stimulus. Examples of leading opioid prescription pain medications are hydrocodone, oxycodon, morphine, and codeine. Heroin is also considered an opioid.
The scale of the opioid abuse problem is huge. A report by the National Academies released in July 2017 says as of 2015, some 2 million Americans age 12 and older are addicted prescription opioid drugs, while 600,000 are addicted to heroin. Drug overdose, mainly by opioids, is now the leading cause of death from unintentional injury in the U.S. About 90 Americans die each day from opioid overdoses, and since 2011, the number of overdose deaths tripled from illicit opioids, such as heroin and fentanyl, a synthetic opioid.
The new report, prepared by 2 analysts employed by BIO, finds pharmaceutical and biotechnology companies have 220 new drugs for pain in their pipelines, with 125 of those treatments in clinical trials. The vast majority of these new therapies (87%) target non-opioid receptors to relieve pain, indicating they use different mechanisms from opioid drugs. By comparison, pharma and biotech companies have more than 2,600 new cancer therapies in development, of which 1,700 are in clinical trials.
Over the past 10 years, says the report, the industry mounted 142 clinical trials for pain drugs formulated to deter abuse, with 12 of those compounds later approved by FDA. Yet, during this same period, FDA approved only 2 drugs that use new biochemical mechanisms for pain. One reason for this low number of FDA approvals is the low success rate for new pain drugs in clinical trials. The report says only 2 percent of new chemical mechanisms for pain make it past early-stage clinical trials to FDA approval, compared to about 10 percent for the industry overall.
The outlook for drugs to treat addiction is even less promising, according to the report. For all types of substance abuse and addiction — alcohol, tobacco, opioids, and other stimulants — only 15 treatments are in pharma and biotech company pipelines beyond preclinical stages, with 5 of those 15 new therapies for alcohol abuse or smoking cessation.
The authors point to a lack of meaningful investment in pain and addiction drugs, particularly from venture capital companies, as part of the problem. From 2007 to 2016, companies with lead drug development programs of any kind dealing with pain received $1.5 billion in venture financing, with $576 million going specifically for new mechanisms to treat pain. In comparison, companies making drugs for cancer with new treatment mechanisms received $10.3 billion over this 10-year period.
For new addiction drugs, the report says, “Venture investment into U.S. companies with lead products in addiction has been virtually nonexistent over the past 10 years.” The authors could find only $16 million over the past 10 years invested in 2 companies with lead products treating addiction, and their products were for alcohol, not drug abuse.
The report notes that new incentives for development of pain and addiction drugs may be needed. The authors cite data that show even with a large potential market, more than 90 percent of current drugs prescribed for pain have a generic option. These and other challenges create uncertainties for investors, even for financing highly innovative drugs.