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New Study Reveals Financial Cost Of Air Pollution Borne By Children And Their Families – Medical Daily

Posted: December 19, 2019 at 2:49 am

It's the defenseless children of the world that are bearing the bulk of environmentally-related diseases such as asthma that can be traced to air pollution, according to the World Health Organization (WHO).

WHO estimates more than 40 percent of the burden of environmentally-related diseases and more than 88 percent of the burden of climate change is borne by children younger than 5 years old. In the United States, disorders such as asthma and attention deficit hyperactivity disorder (ADHD) are prevalent in children and have been increasing over time. Asthma has a prevalence of about 8 percent and ADHD has a prevalence of 10 percent. ADHD is the most commonly studied and diagnosed mental disorder in children and adolescents.

WHO said even disorders with lower prevalence such as autism represent a growing public health concern. Autism affects one in 60 U.S. children.

There is a monetary price to pay for the growth in these afflictions. A new study has, for the first time, quantified the cost of diseases caused by fossil fuel air pollution.

The study by researchers at the Columbia Center for Children's Environmental Health (CCCEH) at Columbia Mailman School of Public Health is the first to compile the estimated per-case costs of six childhood health conditions linked to air pollution estimates that can be incorporated into benefits assessments of air pollution regulations and climate change mitigation policies.

Published in the journal Environmental Research, the study reports case-specific monetary estimates for these six childhood health conditions: preterm birth, low birth weight, asthma, autism spectrum disorder, ADHD and IQ reduction in children. Previous scientific evidence has shown the six are among the known or likely health consequences of prenatal and early childhood exposure to air pollution. Globally, 80 percent of air pollution can be linked to burning of coal, oil, diesel and gas.

"Impacts on children's health are generally under-represented in benefits assessments related to environmental pollution," study co-author Frederica Perera, professor of environmental health sciences and director of translational research at the Columbia Center for Children's Environmental Health, said. "Policies to clean our air and address the serious and escalating problem of climate change will yield numerous benefits for children's health and for the financial health of families and our nation."

The study cited previously published estimates of health costs. It agrees $23,573 is being spent for childhood asthma not persisting into adulthood. A further $3.11 million is being spent for a case of autism with a concurrent intellectual disability. Researchers also provided an example of cumulative costs. About $267 million can be saved from a reduction by just one percent in the number of pre-term births in the U.S. attributable to particulate matter (PM) with a size of 2.5 microns, or PM2.5. PM is a measure of particulate matter, one of several harmful air pollutants.

The study prioritized monetary estimates that factored in both immediate medical costs and longer-term and broad societal costs. It warned its monetary figures are likely underestimates because it didn't adequately capture the long-term health and societal impacts such as effects over the full life course or losses in economic productivity.

A previous study published in 2014 by the same Columbia Mailman School of Public Health showed air quality can influence cognitive development en utero. The team that arrived at this conclusion previously found a correlation between polycyclic aromatic hydrocarbons (PAHs) and developmental delays, reduced IQ and attention problems in children of ages 3 to 6 years old. In this research, the Columbia researchers focused specifically on how PAHs might be connected to concentration and contribute to ADHD symptoms in children. PAHs are pollutants emitted in the air from burning fossil fuels like car exhaust or heating.

This study should not come as a surprise," Dr. Sandy Newmark, founder of the Center for Pediatric Integrative Medicine in San Francisco, said. "Although there is a strong genetic component to ADHD, there is an equally strong environmental influence, and this influence begins with the prenatal environment."

"Other research has shown that ADHD incidence increases with exposure to pesticides and other environmental pollutants during childhood. The bottom line is that the developing brains of our children are highly susceptible to environmental influences of many kinds, and we need to continue to research these exposures and prevent damage whenever possible.

In 2014, study found that air pollution from power plants that used fossil fuels caused nearly 16,000 premature deaths in the U.S. Pixabay

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Lemon Water Helps With Weight Loss, But May Cause These Side Effects Too: Take Note Of Them, Says Luke Coutinho – NDTV News

Posted: December 19, 2019 at 2:49 am

Lemon water must be avoided if you have stomach or mouth ulcers

Weight loss tips: Lemon water is a popular morning tonic that people take for better metabolism and even quick weight loss. However, the same lemon water might not show the same consequences for everyone. The mindset to overdo something is not something which will work in your favour, according to lifestyle coach Luke Coutinho. In one of his recent live sessions on Facebook, he mentions that lemon water does make your body more alkaline, which in turn helps in burning of fat. This, however, does not mean that the more lemon water you drink, the more fat you will burn.

It is important to understand that just because lemon water is a popular remedy for digestion, metabolism, etc, it doesn't mean that it will show the same effects on your body. Whenever you are trying something new, it needs to be done slowly and safely, while observing if it suiting your body or not.

Also read:Follow Lemon Detox Diet Plan For Quick Weight Loss And Better Health

Lemon water is a rich source of Vitamin C and can work as a great immunity booster, if it suits you. It definitely helps in alkalising the body. But, there are some side effects of drinking it, which cannot be ignored.

1. 1-3 cups of lemon water in a day is good enough to reap benefits from it. Drinking lemon water throughout the day can cause damage to tooth enamel. This is because lemon water is acidic in nature.

Drinking lemon water in excess can cause damage to tooth enamelPhoto Credit: iStock

2. For those who already have a weak enamel, even 1 or 2 cups of lemon water can cause damage. Drink lemon water through a straw to prevent damage to your enamel.

3. Consuming lemon water with sugar in can worsen tooth cavities. Cavities contain bacteria that feeds on sugar.

Also read:Diabetes Diet Chart: Here's What Nutritionist Suggests To Keep Blood Sugar Under Control

4. Lemon water must be avoided when you have mouth ulcers as it can aggravate ulcers.

5. Lemon water can be considered to be an excellent remedy for acidity. But, lemon water can also make some people highly acidic. If you feel uneasy after drinking it, then it is not suiting you and you must avoid its consumption.

6. This drink must also be avoided if you have stomach ulcers.

7. Drinking lemon water can also be harmful if you joint pain and arthritis pain as it can aggravate the pain.

Lemon water may worsen joint pain and arthritis painPhoto Credit: iStock

8. People with migraine and severe headaches should check their lemon water consumption. Luke says that there is a direct connection between citrus and migraine headaches. If you get these symptoms too often, its time to cut back on intake of lemon water.

Also read:5 Myths About Migraine Pain You Must Stop Believing

(Luke Coutinho, Holistic Lifestyle Coach - Integrative Medicine)

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.

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IN GOOD HEALTH: Movement Therapy Good for Anxiety? – Tillamook County Pioneer

Posted: December 19, 2019 at 2:48 am

By Linda Tate, Communications Director, Northwest Osteopathic Medical FoundationThis week, we are covering Movement Therapy, sometimes called Dance Therapy. Many believe that anxiety and panic attacks can be treated using movement therapy.An expert in the field explains this style of treatment: Anxiety is a body/mind split that is constructed in the mind but felt in the body. Dance/movement therapy is a psychotherapeutic process that creates balance in the nervous system, ownership of ones own body, and agency through movement by turning anxiety into excitementand giving it someplace to go. Jennifer Frank Tantia, PhD, MS, BC-DMT, LCAT

Have you ever been in a crowd of people, and suddenly you feel as if you have to get away from the situation? It becomes an overwhelming urge to run and hide; to find peace and quiet. Or maybe you are a nail biter and nothing youve done to stop biting your nails has worked? Anxiety can be low level, Im anxious about giving my oral presentation to downright life-altering, I cant leave my houseits too scary out there. Have you ever wondered how that anxiety manifests itself in your mind and ultimately your body?According to Medical News Today, uncertainty of outcomes can trigger an anxious response. Not knowing when something will happen, or even if something will happen, can create anxiety.People who tend to worry will have a higher incidence of anxiety as opposed to those who stay in the moment and can ground themselves when those negative thoughts pop up.This is where dance therapy comes in. Rewiring our brains to stay in the moment, and to focus on ones body instead of ones thoughts. Reconnecting with your physical body is key.Iris Bruninger, Ph.D. states, The body has a deep influence on the mind and vice-versa. Just like running a mile can distract you from the pressures of your to-do list, dance uses expressive movement and breathing to deflate hyper-aroused thoughts. In other words, if youre concentrating on perfecting a pli, youre most likely not thinking about the outrageous bank statement you just got in the mail. Dancing brings us back to a more primitive, and consequently, more liberated state of mind. It causes our thoughts to simplify, to focus on our bodies and our movements instead of the more complicated stressors of life.Theres currently a movement group on the scene called Nia. Nia (pronounced nee-ah), short for neuromuscular integrative action or nonimpact aerobics, is a workout trend that combines the best of modern dance, martial arts, yoga, and tai chi. A sort of East meets West workout, with elements to enhance the body as well as the mind and spirit.I wanted to learn more about this therapy and turned to a woman Ive known since kindergarten, Kellie Chambers, to get the information on how these classes work and what they can do to aide someone in healing from anxiety.Kellie, a Nia instructor herself, tells us about Nia and why she feels its beneficial to anyone looking for healing.Nia is a sensory-based movement and lifestyle practice that conditions the whole body, mind, spirit, and emotion.One of Nias specialized offerings is Nia Moving to Heal. In class we move to feel better, or rather feel to heal. Guided by gentle instruction and creative imagery, Moving to Heal offers a way to move to music with an awareness of your unique bodys way for stress reduction, increased relaxation, improved energy, breathing, stronger heart, brain function, more balance and stability, increased flexibility just to name a fewKellie Chambers teaching a Nia classWhether you are looking for a more high energy Nia class or a more relaxed and soothing Nia Moving to Heal class, both offer movement as medicine for change. We learn to dance through life in a way that brings pleasure to the body and life and to use the body as a guide to discover its own inherent wisdom to heal (to feel better). We become sensation scientists on the dance floor.I have taught Nia for 6 years and am a 1st Degree Black Belt Instructor who owns a studio in Pleasant Hill Oregon called Just Move. I teach 10 classes a week. I feel utterly transformed by this practice. I am stronger, more grounded and joyful, feel younger and can move like I did in my 20s, and I love how much I have changed inside out by learning to listen, trust and move my body my bodys way.I encourage everybody to give it a try!To Find a Nia class near you, click HERE.This video runs for 7 minutes and 52 seconds. Its a good video to watch to understand the connection between Movement Therapy and Anxiety.

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Collaborative Robots: Rai… – Robotics Online

Posted: December 19, 2019 at 2:47 am

by Tanya M. Anandan, Contributing Editor Robotic Industries Association Posted 12/16/2019

Collaborative robotics is more than one kind of robot. It often involves a human working alongside a robot, and the collaborative robot (or cobot) is usually fenceless, but not always. They can have one arm, two arms, or none at all. They can be mobile or portable, small or large. They can work alone or as a fleet. Even standard industrial robots are fair game, thanks to innovations like FreeMove.

Last month we set out to broaden your view of human-robot interaction and collaboration. Were back to do it again. Well show how robots tackle labor shortages, reduce costs and optimize floor space. How they elevate the jobs humans do while improving process efficiency.

From making floral bouquets to inspecting bumpers, and bagging this seasons hottest tech toys, cobots are transforming the human-robot paradigm and knocking down barriers on the shop floor, between entire industries, and on a global scale.

Bumper-to-Bumper CobotsTier 1 automotive supplier Flex-N-Gate Corporation puts collaborative robots to work on the assembly line inspecting bumpers and other fascia components. These camera-wielding cobots use machine vision to inspect assembled components for proper orientation and installation. The robots work alongside their human coworkers without safety cages or other hard guarding to separate man from machine.

The Urbana, Illinois-based company supplies bumpers, exterior trim, lighting, chassis assemblies, and other automotive products. At the suppliers Ionia, Michigan facility, they stamp and assemble steel bumpers for the Ford Ranger pickup truck, among other vehicle platforms. Here, cobots inspect parts in two different assembly areas.

We supply a full bumper assembly module delivered directly to assembly plants, explains Nick Wiegand, Director of Advanced Manufacturing Global Metals and Assembly Group at Flex-N-Gate. We fabricate the steel shells via a progressive stamping process. The steel shells are then either painted, or chrome plated, or in some cases powder coated. Then we have other components that have to be affixed to the bumper, including internal structural components, fasteners, air dams, fog lamps, bezels, front parking assist (FPA) sensors, rear parking assist (RPA) sensors, blind-spot warning (BSW) sensors, integrated wiring harnesses, active air dams/grille shutters, and myriad other plastic and composite finishing accessories.

The amount of electronics that go into a bumper assembly these days is mind-boggling, says Wiegand. Were utilizing camera-carrying cobots in our assembly processes to ensure we have the right color/style combinations, and that all the requisite components based on the part recipe are present and installed correctly.

In one area of the shop floor, workers load a steel bumper onto a fixture in front of a green cobot arm. The FANUC CR-7 collaborative robot outfitted with a Cognex camera and integrated lighting swoops across the part inspecting and error-proofing assembled components. While the robot does its job, the operator can be tending to other areas of the assembly module.

On the moving assembly line, inverted FANUC cobots mounted just above the line workers heads maneuver at different angles, examining parts as they advance down the line. Watch Flex-N-Gates camera-wielding cobots at work.

Our biggest challenge was programming the cobots for line tracking, says Wiegand. Flex-N-Gate was the first in the industry to attempt this feat. We worked with the robot supplier and system integrator to solve issues as they arose.

Cost SavingsAutomated inspection has evolved at Flex-N-Gate. Traditionally, error proofing was done with a bank of overhead cameras, but this approach had its limitations. Fixed cameras made it difficult to see parts at optimal angles for the vision systems to read accurately and repeatedly. Company engineers had a better idea.

Why dont we put a camera at the end of a robot arm and take the camera to the inspection instead? says Wiegand. That was phase one in our evolution.

They mounted a camera on a conventional robot arm. Now they were able to position the camera in ideal locations for inspection and view aspects of parts they couldnt see before. Now they only had one camera to maintain instead of up to a dozen fixed cameras.

Wiegand says some of these cameras can range from $10,000 to $15,000 a piece, so the savings were significant. The next phase in their evolution deploying cobots would further reduce costs.

Space SavingsFlex-N-Gate was performing vision inspection with conventional high-speed, low-payload robots for about a year. Meanwhile, collaborative power and force limiting robots were garnering more attention as their applications grew, setting the stage for the suppliers transition to inspection with collaborative robots.

We were doing this with traditional robots, which required them to be caged and guarded per the RIA safety standards, just like you would any other industrial robot, says Wiegand. Were now able to do the exact same thing with collaborative robots and eliminate all of the guarding and a majority of the safety-related hardware costs. Now an operator can actually work beside the robot in that same station, enabling human work and robotic vision inspection simultaneously.

This collaborative robot cell not only saves costs associated with guarding and required safety devices and interlocks, but it also saves the floor space often required for fenced robot cells.

Inverted collaborative robots inspect automotive components alongside assembly line workers without requiring hard safety fencing. (Courtesy FANUC America Corporation)

Safety FirstThere are different ways to achieve a collaborative robotics application, as explained in Testing Thresholds for Collaborative Robot Safety and evidenced on the bumper assembly line. Besides the inherently collaborative nature of power and force limiting robots, Flex-N-Gate uses an area laser scanner in conjunction with their cobots to further support safety while optimizing production efficiency.

In order for it to be a collaborative application, were limited to a maximum collaborative speed for safety reasons, says Wiegand. In some cases that can be problematic, because were unable to get all the work completed in time with the slower robot travel speeds. In some cases, weve used a safety scanner so that when an operator is not in the area, the robot can run at full speed. When humans come near the robot, it slows down to a safe collaborative speed. The operator can simply touch the robot and it stops.

You can physically just push them out of the way, too. When you restart the robots, they go right back to where they were and carry on with their jobs, he adds.

Wiegand says safety is number one at Flex-N-Gate.

We dot our Is and cross our Ts to ensure that we are in fact integrating these units per the RIA standards and that we are 100 percent safe, he says. We also go a step further and require third-party safety certification.

Proper training for personnel working with and around the new collaborative robots was also a priority.

Traditional robotic safety and avoidance of human-robot interaction is so engrained in our workforce, says Wiegand. Our technicians were sent for collaborative robot-specific training (provided by the robot supplier) and we did safety demonstrations with the plant personnel and operators. It was a bit of a paradigm shift, but it didnt take long for team members to become comfortable working around the collaborative robots.

Ive spent my entire career in automation and robotics, he says. Robots and people occupying the same space has always been a huge no-no. Its cool to see how getting over that hump was surprisingly easy. A lot of it boils down to physically demonstrating that it is, in fact, safe. Showing people something, versus telling them, has a different impact.

Flex-N-Gate has deployed 33 collaborative robots at different facilities throughout the U.S. and Mexico. Worldwide they have approximately 2,000 traditional robots across 62 facilities.

In the last year, weve really gone hard and heavy in the collaborative space, says Wiegand, noting that right now, they primarily use the cobots for vision inspection. As more opportunities present themselves, well continue to look at collaborative robots as a potential solution.

On the West Coast, a different manufacturer was looking to cobots as a potential solution for labor shortages. A robot integrator came to the rescue with two sets of collaborative arms.

Cobot Twins Curb Labor WoesPromotional products supplier iClick had a problem. Their popular PopSockets grips for mobile phones were flying off the shelves, but the Seattle-based company couldnt hire enough workers to keep up with demand. Kitting and bagging product was a tedious job.

Workers were manually attaching the grips to promotional cards and then feeding them one at a time to an automated bagging machine, a labor-intensive process. Even with a crew of four, the workers couldnt keep up with the bagging machine to maximize capacity. Labor continued to be difficult to find and retain.

In an effort to move workers to higher-value jobs, iClick sought out robot integrator House of Design to offer a collaborative robot solution. The FlexBagger system was born.

The robotic kitting and bagging system consists of two ABB YuMi dual-arm collaborative robots. In a carefully choreographed dance of their seven-axis arms, each robot attaches PopSockets to promotional cards and then drops them into the automated bagging machine.

Watch the cobot twins take turns bagging branded PopSockets.

Since each robot must occupy the same space as they deposit assembled items in the bagging area, the timing of the arms needs to be coordinated to avoid collisions. House of Design used ABB RobotStudio to program the robot workstation and ensure smooth movements of its kinematically redundant arms.

Flexible Kitting and BaggingChad Svedin, Project Manager for House of Design in Nampa, Idaho, says the manual bagging process was painstaking. Human workers werent able to put the product in the bags fast enough. With two dual-arm robots working in concert, they can perform the work of four people and keep the automated bagger fully stocked.

Launched in February 2018, this was iClicks first foray into robotics. It was so successful that less than a year later, they ordered another FlexBagger system.

House of Design markets the FlexBagger for other kitting and bagging applications. The YuMi cobot is equipped to grab various small items such as screws, nuts or washers and assemble them in bags. Check out this demo with different sizes and colors of interlocking toy bricks.

Like other power and force limiting cobots, YuMi has special characteristics to help it work collaboratively in close proximity or directly with its human coworkers. It was important to iClick to have a collaborative robot so its workforce could easily enter the robots operating space to remove defective items or replenish products when necessary. The dark gray areas on YuMis arms are padded for safety in the event of contact.

If someone juts their hand into the working system, it bumps into them and freezes in its spot, notes Svedin. A minor bump will stop it from moving.

House of Design trained iClick personnel on safety, and how to run and program the robots.

They loved that the robots looked very humanlike and that they could approach it, says Svedin. It wasnt this thing in a box away from them. They saw it as a part of their crew.

Cobots are part of the crew in unexpected places. Manufacturing isnt the only sector with labor woes. The floral industry is on the verge of a labor crisis and looking to automation for solutions.

Roses and RobotsVisitors to the Automate Show last April may have caught a glimpse of a cobot arranging small bouquets of roses, or you may have even taken home a souvenir bouquet. Some of us skipped the buds for the backstory.

FloraBot is the brainchild of Founder and CEO Alex Frost, a second-generation florist who grew up in his parents retail flower business. For the past dozen years, his Fort Lauderdale, Florida-based software company, QuickFlora, has been providing cloud-based ERP systems for floral retailers.

We work with a lot of retailers in the U.S. and Canada helping them manage their software technology frontend and backend systems. We have a front-row seat to some of their challenges. Over the last 5 to 10 years, there have been fewer and fewer people going into the flower business, so its hard to find qualified floral designers to work in flower shops.

He says you compound that with increasing minimum wage rates in many places such as California, and you have a real labor shortage in the floral industry. Its an environment he thinks is ripe for collaborative robots.

We see them flipping hamburgers, making pancakes and serving coffee. We decided last year, lets bring one of these machines in here and see what it can actually do, says Frost. Can we program it to make flower arrangements? Can we create a turnkey cell for end users?

If you think of Kroger, they have 4,000 stores across the country (marketed under different supermarket brands). Each store needs about 10 to 30 arrangements every day, he says. Those are all made by hand right now. Usually, you have 50 to100 people in a cooler set at 34 degrees. The process is very labor-intensive and you cant scale it. When Valentines Day or Mothers Day comes around and volume increases 5 or 10 times, you cant just hire 5 or 10 times the people that fast when you dont have space. Theres a labor shortage issue, a labor cost issue, and a scalability issue.

Automating Floral DesignFrost sees an emerging market, not only in North America but worldwide. In fact, most of his inquiries come from Western Europe, because labor costs are higher and the European market tends to be more receptive to adopting automation technologies. He notes the evolving niche for precision agriculture, which we examined in Cultivating Robotics and AI for Sustainable Agriculture, where startups and established companies are adapting collaborative robotics for farming.

We sort of fit into that category because were dealing with product that is very sensitive, not heavy, that requires specialized grippers, force control, and vision systems to actually make it work, says Frost. There are a lot of similarities between our technology and that technology in terms of trying to handle delicate flower stems of all shapes and sizes, and then pick and place them into specific xyz coordinates with reasonable cycle time and low defect rate.

He was skeptical himself at first. But as their research and product testing progressed over the last year, he became a believer. They decided to start with a Universal Robots collaborative robot because of their relative ease of use and ease of programming. They have a built-in ecosystem of compatible hardware makers and apps. Theyre also easily portable.

The current FloraBot system uses a UR5 cobot with a Robotiq Hand-E gripper. Previous testing was conducted with grippers from Ubiros and Soft Robotics. Frost says the gripper system has been a big part of the learning process.

What we realized is that nothing worked off the shelf. Absolutely nothing. We had to come up with our own proprietary fingers. Now were working on our own proprietary servo-electric gripper. It will give our end users more flexibility.

Check out this early iteration of the FloraBot system in action on the trade show floor.

Turnkey and Travel-ReadyWhile patents are still pending, FloraBot wont release shots of the near production-ready system. They are currently pilot testing at one company in Miami. They plan to start shipping units in January 2020 right after their official launch at the Consumer Electronics Show (CES).

Frost says the system can assemble AIFD-quality floral arrangements at 100-200 units per hour, 24/7, and with an ROI in less than a year. Right now they plan to sell the system, but eventually, he expects to move to a RaaS model. That way flower companies and growers will be able to try it without making a CapEx investment.

FloraBot supposedly excels at small arrangements about 12 cubic inches. But when you get into larger arrangements like a dozen long-stem roses in a vase, it requires a different kind of gripper. Thats where FloraBot will have to turn to proprietary grippers of their own.

Frost is envisioning a turnkey system they can ship on a 48 in. x 48 in. pallet, basically one robot cell that can do specific tasks within an assembly line. For example, to create an arrangement you may need six cells on the line. One robot that cuts the foam for the container, one that hydrates the foam, one that picks/places the foliage, then one that picks/places the flowers, one that sleeves the arrangement, and another that puts it in the box.

Right now, we see that the machines are capable of doing 75 percent of what humans do in the floral business, whether its a typical flower shop or the mass market, says Frost. Thats really the sweet spot for this technology, the mass market because they crank out high volumes (2000-3000 bouquets) of the same type of arrangements on a daily basis. There will always be a market for people that want something custom. But the reality is most retail florists make the same arrangements week in and week out.

FloraBot has been approached by companies that put flower arrangements in boxes and ship them around the world. There are a lot of new, innovative players in the flower business. Frost says most of the new upstarts are the most receptive to automation.

Weve had requests to do Hawaiian flower leis, which is a very labor-intensive process. Others want us to make different animals covered with roses, which is popular in many countries. Thats also very labor-intensive because you have to cut out a foam model of a little French poodle and then put 600 roses on it. That usually takes 4 to 8 hours. There are definitely cases where machines will take over in terms of production capability.

You might not know that it was created by a robot and you might not care, says Frost. If the customer gets a beautiful flower arrangement that has 12 to 24 stems, the color palette is wonderful and its at their price point, theyre going to be happy. At the end of the day, its about delivering the most value for the customer.

In June, FloraBot exhibited at the International Floriculture Expo (IFE) in Miami, touted as the largest B2B floral event in North America. Frost was astounded by the interest.

Everyone at the flower show, big growers and bouquet makers, came over to the booth and asked how they could use the robot to cut their payroll. No one asked or cared about the technology, or whether it worked or not. It just came down to cost and ROI. CFOs came over. I never had so many C-suite-level people engage in serious discussions at a show. That really tells us were on the right path.

FloraBot recently beat a path all the way to Boston, where they opened a new office at MassRobotics, one of the major robotics clusters. It will be interesting to see what comes next.

Five years from now there will be no humans making flower arrangements, says Frost, because when you see labor savings in the range of 50 to 75 percent, it just doesnt make economic sense anymore.

From rosebuds to electrical connectors, cobots are popping up in industries far and wide.

Mobile Production AssistantCollaborative robots also come in mobile varieties, including this mobile manipulator that integrates an autonomous mobile platform with a six-axis articulating arm. Stubli Electrical Connectors relies on the HelMo mobile robot system from Stubli Robotics to help supplement production during peak demand or during human workforce shortages due to illness or other unforeseen absences.

Once trained, HelMo can handle almost any manual job on the various assembly lines at the connector manufacturers facility in Allschwil, Switzerland. The production assistant navigates to its own workstation, decelerates or stops when human coworkers come too close, and then automatically resumes its operation when the protected workspace is clear.

As soon as HelMo arrives at its workstation, the cobot precisely positions itself within a tenth of a millimeter by referencing three permanent orientation points at the workstation. HelMo then connects itself via a multi-coupling to the fixed supply sockets for electricity and compressed air, then starts its shift.

The mobile cobot is also equipped with an automatic tool change system. One day it could be working with connector housings and contact pins. The next day might be some other stage in the assembly process, wherever its needed.

Integrated atop the mobile platform is a standard Stubli TX2-90L robot with a 15 kg payload and 1,200 mm reach. Watch the HelMo mobile robot system autonomously load rotary tables for manufacturing pneumatic couplings, and later in the footage safely navigate around human coworkers and other equipment in the production space.

The flexible production assistant monitors its environment with three integrated laser scanners. HelMo can perform its tasks automatically or in collaboration with humans.

Material Transport CobotsIn Japan, a fleet of mobile robots collaborates with humans. OMRONs FA sensor manufacturing facility in Ayabe wanted to upgrade its material transport system with a fully automated solution for transporting work-in-progress (WIP) components throughout the factory.

Ayabe is both a production facility and a development facility. In addition to producing OMRON technologies for customers, it also serves as an environment for testing and optimizing new products, including the OMRON LD mobile robot. Moving away from cumbersome conveyor belts that are difficult to rearrange, the engineering team opted for this flexible mobile solution where robots autonomously navigate their way through dynamic environments.

Each LD mobile robot gets its configuration data from the Enterprise Manager, which helps optimize traffic flow by sharing each robots position and trajectory with other robots in its vicinity. This allows each mobile robot to make path adjustments on the fly to avoid people, obstacles and other robots in its path.

The Enterprise Manager allows operators to manage map and configuration updates from a central communication point. These updates are then pushed to each mobile robot in the fleet. The Enterprise Manager also provides a queuing manager to receive job requests from call buttons and automation equipment, and then dispatch jobs to the mobile robots.

In the Ayabe factory, the mobile robots carry product containers between the assembly, final inspection and shipment stations. Since the mobile robot system is connected with the manufacturing engineering system (MES), transportation orders through the MES are conducted according to the work in progress. Watch Ayabes mobile robot fleet in action.

To make transportation more efficient, each LD mobile robot has two lifts, one on the front and one on the back, which makes it possible to carry materials to two destinations in a single trip.

We were able to automate 75 percent of all material transport tasks using these mobile robots, says OMRONs Assistant Manager Makoto Kasuya. People used to move containers in batches, but now robots can move them more frequently. As a result, the lead time needed to transport material has decreased by 80 percent on average.

The overall solution also reduces the expense and effort required for future investments, as LD mobile robots can be easily implemented in other factories without incurring new design costs.

Using its workforce for higher-value tasks instead of moving around products and materials will help Japans manufacturing sector address a growing labor shortage crisis as the countrys population continues its rapid decline. Workers at OMRONs Kusatsu factory used to manually transport up to 300 containers per day. Now the LD mobile fleet does what robots do best, enabling the people to focus on more creative work.

Creativity is still the human element. We need inspiration, ingenuity and vision, the kind that dreams up unique floral designs, innovative tech toys, and adds new functionality and value to age-old automotive components. Robots push us to be better.

RIA Members featured in this article:ABB RoboticsFANUC America CorporationOMRON AutomationStubli North America

Originally published by RIA via http://www.robotics.org on 12/16/2019

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Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 – JD Supra

Posted: December 18, 2019 at 11:52 am

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA teams second year-end post will provide an overview of 2019 with a focus on the drug, biologic, and regenerative medicine programs at the agency. In many ways, the past year could be called a business as usual year for the FDAs drugs and biologics centers in that they continued to make progress on all of large-scale programs and priorities initiated by former-Commissioner Scott Gottlieb, who left the agency in April. FDA has been under the leadership of an Acting Commissioner since that time, although Texas radiation oncologist Dr. Stephen Hahn will be taking the reins soon following his confirmation by the full Senate in a 72-18 vote on December 12, 2019. (The Senate HELP Committee advanced the nominee on December 3, 2019; see our blog post just prior to that committee vote here.)

At the same time, however, the final months of 2019 have exposed several challenges for various FDA programs that operate under the extensive drug and biologic authorities contained in the Food Drug & Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), respectively. The agency will be forced to grapple with many of these issues directly and deliberately in 2020as a result of deadlines of the agencys own making as well as external pressures coming from other parts of D.C. and from the rapidly changing nature of the U.S. health care system.

Business as Usual When Getting New Drugs, Generic Drugs, and Biosimilars to Market and Promoting Competition under Various Action Plans But Challenges Are Emerging Related to Accelerated Approval and Breakthrough Products

According to data presented by the Office of New Drugs in early December (see ONDs slides here), FDA had another extremely productive year when it comes to its approval of new molecular entities that address a unique blend of therapeutic areas. The agency approved 45 new molecular entities in FY 2019 (October1, 2018 to September30, 2019), of which 71%, or 32 products, received priority review status and 23 were designated as orphan drugs intended to treat rare diseases. As OND emphasized in the presentation, several of those new product approvals are notable for their uniqueness and therefore, in the agencys view, 2019 reflects not only quantity but [also] quality. The OND presentation also highlights a significant amount of other information on new molecular entity approvals and may be of interest to those readers who want to take a deeper dive into the data.

In addition to advancing important new drugs and biologics to market, former Commissioner Gottlieb is well-known for having spearheaded to development of a Drug Competition Action Plan (DCAP) and a Biosimilars Action Plan (BAP) during his nearly two-year tenure as head of the agency. Some of our prior coverage of the DCAP and BAP is available here. In general terms, the DCAP encourages market competition for generic drugs and helps to bring greater efficiency and transparency to the generic drug review process; the BAP aims to achieve similar goals for biosimilar products as the agency continues its implementation of the 2010 Biologics Price Competition and Innovation Act (BPCIA), including the critical drug-to-biologic transition that will occur by operation of law in March of 2020.

FDA continued to make progress on its various goals under these two initiatives during 2019. Some examples of this progress can be captured with these two data points:

With all of these wins, however, FDA still faces its fair share of challenges related to its expedited drug and biologic programs, especially as it appears to have accelerated its review of products intended for diseases with an unmet need to breakneck speed. Indeed, the OND presentation from early December also added that for FY 2020 and as of November 21, 2019, the agency had already approved 13 such drugs, suggesting that next year could be a record-breaking one in terms of innovative drug product approvals. A recent Bloomberg Law article (available here) used the phrase breakneck speed to describe the agencys actions in this space based on several recent FDA approvals of new molecular entities that have come months in advance of their assigned target dates. The Bloomberg Law article highlights that in response to FDAs speediness in reaching approval decisions on new drugs and biologics for diseases with unmet needs, patient advocates and, increasingly, insurers that have to pay for those treatments are starting to raise concerns that these products lack sufficient safety or effectiveness data.

Relatedly, there has been increasing pressure on FDA to remove certain accelerated approval drugs from the market following a failure by the drug product sponsor to confirm the efficacy or clinical benefits of the product in the required post-marketing confirmatory clinical trial. The most visible example of this regulatory challenge came in October 2019 when FDA convened an advisory committee to recommend whether it should withdraw accelerated approval from hydroxyprogesterone caproate injection (marketed under the brand name Makena for the prevention of preterm birth in pregnant women). FDAs Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval, with the dissenters favoring leaving Makena on the market while requiring the sponsor to conduct a new confirmatory trial. (Notably, no one voted for the option of leaving it on the market without requiring a new confirmatory trial.)Among the concerns of some members who voted to leave the product on the market with a new clinical trial obligation was that the drugs withdrawal would leave no safe treatment options for pregnant women at high risk of preterm birth. FDA will have to make a final decision regarding what to do about Makena in 2020, and it undoubtedly will face intense criticism (and potentially legal challenge) no matter what route it chooses to take for this public health quandary in which it finds itself.

In a similar vein, FDA official Dr. Richard Pazdur participated in a Senate briefing on December 10, 2019, in which he and other speakers defended the Breakthrough Therapy Designation program. FDA insisted again that the designation was intended to let the agency have earlier interactions with drug sponsorsand that it was not meant to be an early rating system for drugs or a signal of how they might do commercially. Given that the Breakthrough program was created in 2012 and is considered to be wildly successful, some speakers at the briefing expressed surprise that there was still any confusion about its purpose and function. Whether Congress picks up any of these emerging areas for consideration as part of FDAs 2022 user fee reauthorization packages remains to be seenas those negotiations will begin in earnest after the New Year, but the issues certainly are complex enough to allow for robust policy discussions to occur.

Finally, there are expected to be bumps in the road with the upcoming March 2020 transition of proteins previously approved under New Drug Applications (NDAs) to Biologics License Applications (BLAs)for which FDA only finalized its guidance for industry last year. The March 2020 transition date was established under the BPCIA and the agency does not have discretion in getting the transition done (only in how it handles the logistical and administrative issues created by transitioning approved products in this way). Check out our prior blog post on the final deemed to be a license transition guidance.

Business as Usual with the Rapid Pace of FDAs Issuance of Agency Guidance But Challenges Are Emerging Related to Judicial Deference to FDA Decision-Making

FDA guidance documents for all regulated product categories continued to be released on a regular basis this year, including several related to areas of agency priorities under the DCAP and BAP including the final biosimilar interchangeability guidance issued in May (see our blog post here) and a draft guidance on insulin interchangeability issued in November 2019. The latter also relates to the March 2020 NDA-to-BLA transition, as insulins are one of the largest class of products that will be transitioning into regulation as biologics, making them open to what is expected to be more efficient competition through the BPCIAs biosimilar pathway than what was possible in the past as insulin NDAs.

Despite the accelerated pace of the issuance of Agency guidance, however, FDA is beginning to face more challenges related to its decision-making and the scope of its exercise of agency discretion. In particular, a significant District Court for the District of Columbia ruling issued on December 6, 2019, Genus Medical Technologies, LLC v. FDA, provides hints of a potential shift in judicial deference to certain agency actions. The court vacated FDAs classification of a medical imaging liquid as a drug rather than as a device after determining that FDA did not have discretion to decide how to regulate a product merely because the definitions of drug and device overlap in the FD&C Act.

According to the district court judge, FDA was not interpreting the drug/device definitions in the statute properly, and Congress did not intend to allow the agency unfettered discretion to pick between the two categories. Rather, the court found that the text of the definitions are clear and do not create a gap or any ambiguity for FDA to fill with an exercise of agency discretion. This recently issued decision may indicate a potential shift in how courts are going to apply long-standing precedents related to judicial deference to agency decisions. If FDA decides to appeal the Genus ruling, it may end up at the Supreme Court as one of many expected challenges to the doctrines that established our current framework for judicial deference of an administrative agencys interpretation of an ambiguous statute.

Business as Usual with FDAs Comprehensive Regenerative Medicine Framework and Stepped up Enforcement Against Stem Cell Clinics Offering Unlawful Products But What Happens in November 2020 When the Enforcement Discretion Period Ends?

One of the first FDA press releases for 2019 was co-authored by former Commissioner Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks and was focused on the agencys new policies aiming to advance the development of safe and effective cell and gene therapies. In the press release, the agency leaders predicted that by 2020, FDA would receive more than 200 Investigational New Drug Applications (INDs) for cell and gene therapies each year. The agency has continued to work diligently to increase its staff in CBER to conduct clinical reviews for such INDs and to try to keep pace with the industrys development of these innovative technologies.

As we discussed in our update on FDAs Comprehensive Regenerative Medicine Policy Framework earlier this year, the agency is prioritizing two parallel goals: (1) clarifying the regulatory criteria for product marketing and providing support and guidance to legitimate product developers; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market. The second prong of this comprehensive plan for regenerative medicine products was the topic of one of Dr. Gottliebs very last statements as Commissioner before he left the agency, issued on April 3, 2019 in conjunction with CBER Director Dr. Marks, indicating how important this area is to the agencys current public health priorities.

In the April 2019 statement, Drs. Gottlieb and Marks acknowledged FDAs challenges and efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, citing several Warning Letters issued to manufacturers that violated current good manufacturing practices (CGMPs) for human cells and tissue products. They noted that it was of particular concern given that the industry was nearly halfway through the period during which the FDA intends to exercise enforcement discretion for certain regenerative medicine products with respect to INDs and premarket approval requirements. Now that it is December 2019, that deadline is even closer with less than one year left. November 2020 is the end of the three-year period of enforcement discretion announced by FDA when it first articulated the policies and goals of this comprehensive framework in 2017. See our prior posts on the topic here and here.

Under the Comprehensive Regenerative Medicine Policy Framework, FDA appears to have stepped up the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019. In conjunction with a Warning Letter issued on December 5, 2019 to two related companies for processing and marketing unapproved umbilical cord blood-derived cellular products, Dr. Marks of CBER reiterated the agencys concerns about safety and reminded the public of the upcoming compliance deadline: As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the [FD&C Act] and FDAs regulations.

Dr. Marks was referring to two Untitled Letters that were issued to stem cell product distributors on November 20 and November 25, 2019, respectively. The press release cited above also added that the agency had also recently sent 20 letters to manufacturers and health care providers noting that it has come to [FDAs] attention that they may be offering unapproved stem cell products, reiterating the FDAs compliance and enforcement policy.

FDA also prevailed this year in the U.S. District Court of the Southern District of Florida against a stem cell clinic charged with violating the FD&C Act and the PHS Act. In June 2019, the court held that the defendants adulterated and misbranded a stem cell drug product made from a patients adipose tissue without FDA approval and for significant deviations from CGMPs, issuing a permanent injunction as requested by the Department of Justice on FDAs behalf. The agencys statement on that important court win by the government is available here.

Lastly, on December 6, 2019, FDA issued a Public Safety Notification on Exosome Products. The safety notification informed the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes, which came to FDAs attention through the Centers for Disease Control and Prevention, the Nebraska Department of Health and Human Services, and others. There are currently no FDA-approved exosome products and, to be honest, we are not even sure what such a product would be since an exome consists of all the sequenced exons within a single human genome after the introns are removed. (So were the clinics administering complete exomes to patients? that seems unlikely.)But what we found noteworthy about this public safety notice is the forceful and direct language FDA used when describing the unscrupulous conduct of the sellers of these products:

Certain clinics across the country, including some that manufacture or market violative stem cell products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that they these products do not fall under the regulatory provisions for drugs and biological products that is simply untrue. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the [PHS Act] and the [FD&C Act] and are subject to premarket review and approval requirements.

The clinics currently offering these products outside of FDAs review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.

As we enter the final year of FDAs enforcement discretion period, perhaps these public notices and Warning/Untitled Letters will become even more frequent and the agency will become even more frustrated by the ongoing violations and medical practitioners who flout federal law. This area will see substantial activity in 2020 and we will be watching closely to see what changes, if anything, about FDAs approach in November when the deadline to come into compliance ends. Will there be widespread FBI raids on stem cell clinics engaged in this kind of bad behavior? Only time will tell.

Final Thoughts: A Few Other Business as Usual Activities in the Therapeutic Product Areas and Prescription Drug Advertising Enforcement

Although we have highlighted what we view as some important challenges for the FDA to address in the coming months, other areas continue to be business as usual without anything very new to report. FDA continues to invest significant resources into improving the quality of compounded drugs and ensuring compliance with Sections 503A and 503B of the FD&C Act. Drug compounding was another topic of one of Dr. Gottliebs very last statements as Commissioner on April 3, 2019, in which he laid out the 2019 compounding priorities that included maintaining quality manufacturing and compliance and regulating compounding from bulk drug substances.

Notwithstanding all the efforts by FDA and State regulators in this area over the past several years, the agency continues to see concerning activity when it comes to compounded drugs, such as problems related to the condition under which compounded sterile medicines are made, which raisesignificant risks to patients. As a result, FDA has made it an intense area of focus to take enforcement actions against compounders who fail to produce sterile drugs in compliance with the law. During the past year, for example, FDA has won at least four permanent injunctions against various compounders after the agency identified behavior that posed a significant risk to public health and safety.

In addition, in 2019 FDA also increased its activities towards reducing and mitigating the impact of drug shortages on the health care system. See our prior blog post on Drug Shortages.

Finally, after a fairly slow year of enforcement in the prescription drug advertising space, the last two months of 2019, at least as of December 12th, have given us three (!) letters two untitled and one warning from the FDAs Office of Prescription Drug Promotion (OPDP). Most interestingly, the Warning Letter issued on December 2, 2019 for omitting warnings about the most serious risks associated with [a medication-assisted treatment] drug from promotional materials was announced to the public via FDA press release, which is not a typical action for normal-course OPDP letters to industry. The drug in question, approved for the prevention of relapse to opioid dependence following opioid detoxification, is associated with several significant risks including potential opioid overdose. Given the countrys public health emergency that is the opioid epidemic, FDA appears to have felt the need to make the deficiencies in the advertisement and those risks more widely publicized. So another thing we will be watching for in the New Year is whether this OPDP action represents the beginning of a new trend by the agency to publicize these Warning Letters more directly, or whether its advertising enforcement activities may be picking up due to industrys evolving approaches to promoting therapeutic products.

If you made it to the end of this post, thank you for reading our tome, and we hope you found it helpful and interesting! Stay tuned next week for our third and final FDA year-end blog post.

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Gene Therapy for Sickle-Cell Anemia Looks Promisingbut It’s Riddled With Controversy – Singularity Hub

Posted: December 18, 2019 at 11:51 am

Gene therapy is fighting to enter mainstream medicine. With sickle cell disease, the fight is heating up.

Roughly two years ago, the FDA made the historic decision to approve the first gene therapy in the US, finally realizing the therapeutic potential of hacking our biological base code after decades of cycles of hope and despair. Other approvals soon followed, including Luxturna to target inherited blindness and Zolgensma, a single injection that could save children with a degenerative disease from their muscles wasting away and dying before the age of two.

Yet despite their transformative potential, gene therapy has only targeted relatively rareand often fataldisorders. Thats about to change.

This year, a handful of companies deployed gene therapy against sickle-cell anemia, a condition that affects over 20 million people worldwide and 100,000 Americans. With over a dozen therapies in the run, sickle-cell disease could be the indication that allows gene therapy to enter the mainstream. Yet because of its unique nature, sickle-cell could also be the indication that shines an unflinching spotlight on challenges to the nascent breakthrough, both ethically and technologically.

You see, sickle-cell anemia, while being one of the worlds best-known genetic diseases, and one of the best understood, also predominantly affects third-world countries and marginalized people of color in the US. So far, gene therapy has come with a hefty bill exceeding millions; few people afflicted by the condition can carry that amount. The potential treatments are enormously complex, further upping costs to include lengthy hospital stays, and increasing potential side effects. To muddy the waters even more, the disorder, though causing tremendous pain and risk of stroke, already has approved pharmaceutical treatments and isnt necessarily considered life-threatening.

How we handle gene therapies for sickle-cell could inform many other similar therapies to come. With nearly 400 clinical trials in the making and two dozen nearing approval, theres no doubt that hacking our genes will become one of the most transformative medical wonders of the new decade. The question is: will it ever be available for everyone in need?

Even those uninterested in biology have likely heard of the disorder. Sickle-cell anemia holds the crown as the first genetic disorder to be traced to its molecular roots nearly a hundred years ago.

The root of the disorder is a single genetic mutation that drastically changes the structure of the oxygen-carrying protein, beta-globin, in red blood cells. The result is that the cells, rather than forming their usual slick disc-shape, turn into jagged, sickle-shaped daggers that damage blood vessels or block them altogether. The symptoms arent always uniform; rather, they come in crisis episodes during which the pain becomes nearly intolerable.

Kids with sickle-cell disorder usually die before the age of five; those who survive suffer a lifetime of debilitating pain and increased risk of stroke and infection. The symptoms can be managed to a degree with a cocktail of drugsantibiotics, painkillers, and a drug that reduces crisis episodes but ups infection risksand frequent blood transfusions or bone marrow transplants. More recently, the FDA approved a drug that helps prevent sickled-shaped cells from forming clumps in the vessels to further combat the disorder.

To Dr. David Williams at Boston Childrens Hospital in Massachusetts, the availability of these treatmentshowever inadequatesuggests that gene therapy remains too risky for sickle-cell disease. Its not an immediately lethal diseaseit wouldnt be ethical to treat those patients with a highly risky experimental approach, he said to Nature.

Others disagree. Freeing patients from a lifetime of risks and pain seems worthy, regardless of the price tag. Inspired by recent FDA approvals, companies have jumped onto three different treatments in a bitter fight to be the first to win approval.

The complexity of sickle-cell disease also opens the door to competing ideas about how to best treat it.

The most direct approach, backed by Bluebird Bio in Cambridge, Massachusetts, uses a virus to insert a functional copy of the broken beta-globin gene into blood cells. This approach seems to be on track for winning the first FDA approval for the disorder.

The second idea is to add a beneficial oxygen-carrying protein, rather than fixing the broken one. Here, viruses carry gamma-globin, which is a variant mostly present in fetal blood cells, but shuts off production soon after birth. Gamma-globin acts as a repellent that prevents clotting, a main trigger for strokes and other dangerous vascular diseases.

Yet another idea also focuses on gamma-globin, the good guy oxygen-carrier. Here, rather than inserting genes to produce the protein, the key is to remove the breaks that halt its production after birth. Both Bluebird Bio and Sangamo Therapeutics, based in Richmond, California, are pursing this approach. The rise of CRISPR-oriented companies is especially giving the idea new promise, in which CRISPR can theoretically shut off the break without too many side effects.

But there are complications. All three approaches also tap into cell therapy: blood-producing cells are removed from the body through chemotherapy, genetically edited, and re-infused into the bone marrow to reconstruct the entire blood system.

Its a risky, costly, and lengthy solution. Nevertheless, there have already been signs of success in the US. One person in a Bluebird Bio trial remained symptom-free for a year; another, using a CRISPR-based approach, hasnt experienced a crisis in four months since leaving the hospital. For about a year, Bluebird Bio has monitored a dozen treated patients. So far, according to the company, none has reported episodes of severe pain.

Despite these early successes, advocates worry about the actual impact of a genetic approach to sickle-cell disease.

Similar to other gene therapies, the treatment is considered a last-line, hail Mary solution for the most difficult cases of sickle cell disease because of its inherent risks and costly nature. Yet end-of-the-line patients often suffer from kidney, liver, and heart damages that make chemotherapy far too dangerous.

Then theres the problem of global access. Some developing countries, where sickle-cell disease is more prevalent, dont even have consistent access to safe blood transfusions, not to mention the laboratory equipment needed for altering blood-producing stem cells. Recent efforts in education, early screening, and prevention have also allowed people to live longer and reduce the stigma of the disorder.

Is a $1 million price tag ever attainable? To combat exhorbitant costs, Bluebird Bio is offering an installment payment plan for five years, which can be terminated anytime the treatment stops working. Yet for patients in South Africa, India, or Cambodia, the costs far exceed the $3 per month price tag for standard treatment. Even hydroxyurea, the newly-approved FDA drug to reduce crisis pain episodes, is just a fraction of the price tag that comes with gene therapy.

As gene therapy technologies are further refined and their base cost reduced, its possible that overall costs will drop. Yet whether these treatments will be affordable in the long run remains questionable. Even as scientists focus on efficacy rather than price tag, NIH director Dr. Francis Collins believes not thinking about global access is almost unethical. There are historical examples for optimism: vaccines, once rather fringe, now touch almost every corner of our world with the help of scientific knowledge, advocacy groups, andfundamentallyproven efficacy.

With the rise of gene therapy, were now in an age of personalized medicine beyond imagination. Its true that perhaps sickle-cell disease genetic therapies arent quite there yet in terms of safety and efficacy; but without tackling access issues, the therapy will be stymied in its impact for global good. As genetic editing tools become more powerful, gene therapy has the potential to save even more livesif its made accessible to those who need it most.

Image Credit: Image by Narupon Promvichai from Pixabay

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Global Stem Cell Therapy Market to Surpass US$ 40.3 Billion by 2027 Coherent Market Insights – Business Wire

Posted: December 18, 2019 at 11:51 am

SEATTLE--(BUSINESS WIRE)--According to Coherent Market Insights, the global stem cell therapy market was valued at US$ 7,313.6 million in 2018, and is expected to exhibit a CAGR of 21.1% over the forecast period (2019-2027).

Key Trends and Analysis of the Stem cell therapy Market:

Key trends in market are increasing incidence of cancer and osteoporosis, rising number of research and development activities for product development, and adoption of growth strategies such as acquisitions, collaborations, product launches by the market players.

Key players are focused on launches of production facility for offering better stem cell therapy in the potential market. For instance, in January 2019, FUJIFILM Cellular Dynamics, Inc., a subsidiary of FUJIFILM Corporation, announced to invest around US$ 21 Mn for building new cGMP-compliant production facility, in order to enhance production capacity of induced pluripotent stem (iPS) cell for the development of cell therapy and regenerative medicine products. The new facility is expected to begin its operations by March 2020.

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Market players are adopting inorganic growth strategies such as acquisitions and collaborations, in order to enhance their offerings in the potential market. For instance, in August 2019, Bayer AG acquired BlueRock Therapeutics, a company developing cell therapies based on induced pluripotent stem cell (iPSC) platform. This acquisition is expected to strengthen Bayers market position in the stem cell therapy market.

Furthermore, increasing research and development activities of stem cells by research organizations to provide efficient treatment options to patients suffering from various chronic diseases is expected to drive growth of the stem cell therapy market over the forecast period. For instance, in January, 2019, the Center for Beta Cell Therapy in Diabetes and ViaCyte, Inc. initiated a trial of human stem cell-derived product candidates in type 1 diabetes patients in Europe.

However, high cost of preservation of stem cells and other factors is expected to hamper growth of stem cell therapy market over the forecast period. High cost of stem cell storage is a factor that is expected to hinder growth of the market. For instance, according to the Meredith Corporation, a private bank generally charges US$ 1,200 to US$ 2,300 to collect cord blood at the time of delivery, with annual storage fees of US$ 100 to US$ 300 each year. Thus, high cost associated with stem cell storage combined with high production cost are expected to hinder growth of the market, especially in emerging economies.

Key Market Takeaways:

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Market Segmentations:

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Scientists find way to supercharge protein production – Washington University School of Medicine in St. Louis

Posted: December 18, 2019 at 11:51 am

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Discovery promises to aid production of protein-based drugs, vaccines, other biomaterials

Tubes of green fluorescent protein glow more brightly when they contain more of the protein. Researchers at Washington University School of Medicine have found a way to increase protein production up to a thousandfold, a discovery that could aid production of proteins used in the medical, food, agriculture, chemical and other industries.

Medicines such as insulin for diabetes and clotting factors for hemophilia are hard to synthesize in the lab. Such drugs are based on therapeutic proteins, so scientists have engineered bacteria into tiny protein-making factories. But even with the help of bacteria or other cells, the process of producing proteins for medical or commercial applications is laborious and costly.

Now, researchers at Washington University School of Medicine in St. Louis have discovered a way to supercharge protein production up to a thousandfold. The findings, published Dec. 18 in Nature Communications, could help increase production and drive down costs of making certain protein-based drugs, vaccines and diagnostics, as well as proteins used in the food, agriculture, biomaterials, bioenergy and chemical industries.

The process of producing proteins for medical or commercial applications can be complex, expensive and time-consuming, said Sergej Djuranovic, PhD, an associate professor of cell biology and physiology and the studys senior author. If you can make each bacterium produce 10 times as much protein, you only need one-tenth the volume of bacteria to get the job done, which would cut costs tremendously. This technique works with all kinds of proteins because its a basic feature of the universal protein-synthesizing machinery.

Proteins are built from chains of amino acids hundreds of links long. Djuranovic and first author Manasvi Verma, an undergraduate researcher in Djuranovics lab, stumbled on the importance of the first few amino acids when an experiment for a different study failed to work as expected. The researchers were looking for ways to control the amount of protein produced from a specific gene.

We changed the sequence of the first few amino acids, and we thought it would have no effect on protein expression, but instead, it increased protein expression by 300%, Djuranovic said. So then we started digging in to why that happened.

The researchers turned to green fluorescent protein, a tool used in biomedical research to estimate the amount of protein in a sample by measuring the amount of fluorescent light produced. Djuranovic and colleagues randomly changed the sequence of the first few amino acids in green fluorescent protein, generating 9,261 distinct versions, identical except for the very beginning.

The brilliance of the different versions of green fluorescent protein varied a thousandfold from the dimmest to the brightest, the researchers found, indicating a thousandfold difference in the amount of protein produced. With careful analysis and further experiments, Djuranovic, Verma and their collaborators from Washington University and Stanford University identified certain combinations of amino acids at the third, fourth and fifth positions in the protein chain that gave rise to sky-high amounts of protein.

Moreover, the same amino-acid triplets not only ramped up production of green fluorescent protein, which originally comes from jellyfish, but also production of proteins from distantly related species like coral and humans.

The findings could help increase production of proteins not only for medical applications, but in food, agriculture, chemical and other industries.

There are so many ways we could benefit from ramping up protein production, Djuranovic said. In the biomedical space, there are many proteins used in drugs, vaccines, diagnostics and biomaterials for medical devices that might become less expensive if we could improve production. And thats not to mention proteins produced for use in the food industry theres one called chymosin that is very important in cheese-making, for example the chemical industry, bioenergy, scientific research and others. Optimizing protein production could have a broad range of commercial benefits.

Verma M, Choi J, Cottrell KA, Lavagnino Z, Thomas EN, Pavlovic-Djuranovic S, Szczesny P, Piston DW, Zaher HS, Puglisi JD, Djuranovic S. A short translational ramp determines the efficiency of protein synthesis. Nature Communications. Dec. 18, 2019. DOI: 10.1038/s41467-019-13810-1

This work is supported by the National Institutes of Health (NIH), grant numbers R01 R01GM112824, R01GM51266, R01GM113078, R01DK115972 and T32GM007067; the Skandalaris Center LEAP Award; JDRF, award number 3-APF-2018-573-A-N; and Stanford University Bio-X Fellowship.

SD holds US Provisional Patent #62/540,897 Methods to modulate protein translation efficiency. This patent is owned by Washington University and managed by the Washington University Office of Technology Management (reference numberT061889)

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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The 3D cell culture market is projected to reach USD 1,846 million by 2024 from USD 892 million in 2019, at a CAGR of 15.7% – PRNewswire

Posted: December 18, 2019 at 11:51 am

NEW YORK, Dec. 17, 2019 /PRNewswire/ -- The global 3D cell culture market is projected to grow at a CAGR of 15.7% during the forecast period.

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The 3D cell culture market is projected to reach USD 1,846 million by 2024 from USD 892 million in 2019, at a CAGR of 15.7%. The growth in this market is primarily driven by the increasing focus on developing alternatives to animal testing, growing focus on personalized medicine, increasing incidence of chronic diseases, and the availability of funding for research. On the other hand, the lack of infrastructure for 3D cell-based research and the high cost of cell biology research are expected to limit market growth during the forecast period.

The microfluidics-based 3D cell cultures segment is projected to grow at the highest CAGR during the forecast period.Based on product, the 3D cell culture market is segmented into scaffold-based, scaffold-free, microfluidics-based, and magnetic & bioprinted 3D cell cultures.The microfluidics-based segment is expected to register the highest CAGR during the forecast period.

Funding initiatives from various government and private investors are among the key factors driving the growth of this market.

The cancer and stem cell research segment accounted for the largest share of the 3D cell culture market in 2018.On the basis of application, the 3D cell culture market is segmented into cancer & stem cell research, drug discovery & toxicology testing, and tissue engineering & regenerative medicine.The cancer & stem cell research segment accounted for the largest share of the market in 2018.

The increasing prevalence of cancer and significant funding initiatives for cancer research from the government as well as the private sector are some of the major factors driving the growth of this application segment.

Europe to witness high growth during the forecast period.Based on region, the 3D cell culture market is segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). The European market is expected to grow at the highest CAGR owing to the growth of the pharmaceutical and biotechnology industry, increasing incidence of cancer, growing number of venture capital investments, strategic expansion of market players in the region, recent commercialization of microfluidic-based products, increasing presence of major market players, and the large number of research activities in the region.

The primary interviews conducted for this report can be categorized as follows: By Company Type: Tier 1: 50%, Tier 2: 30%, and Tier 3: 20% By Designation: C-level: 37%, D-level: 29%, and Others: 34% By Region: North America: 38%, Europe: 23%, Asia: 30%, and the RoW: 9%

List of companies profiled in this report Thermo Fisher Scientific (US) Corning Incorporated (US) Merck (Germany) Lonza AG (Switzerland) REPROCELL Incorporated (Japan) TissUse (Germany) InSphero (Switzerland) Synthecon (US) 3D Biotek (US) CN Bio (UK) Hamilton Company (US) MIMETAS (Netherlands) Emulate (US) Hrel Corporation (US) QGel SA (Switzerland) SynVivo (US) Advanced BioMatrix (US) Greiner Bio-One International (Austria) PromoCell (Germany)

Research Coverage:The report provides an overview of the 3D cell culture market.It aims at estimating the market size and growth potential of this market across different segments such as product, application, end user, and region.

The report also includes an in-depth competitive analysis of the key players in the market, along with their company profiles, recent developments, and key market strategies.

Key Benefits of Buying the Report:The report will help the market leaders/new entrants in the 3D cell culture market by providing them with the closest approximations of revenues for the overall market and its subsegments.This report will help stakeholders to understand the competitive landscape better and gain insights to position their businesses and help companies adopt suitable go-to-market strategies.

The report also helps stakeholders understand the pulse of the market and provide them with information regarding key market drivers and opportunities.

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The 3D cell culture market is projected to reach USD 1,846 million by 2024 from USD 892 million in 2019, at a CAGR of 15.7% - PRNewswire

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GBT and Syros Partner to Discover, Develop and Commercialize Novel Therapies for Sickle Cell Disease and Beta Thalassemia – BioSpace

Posted: December 18, 2019 at 11:51 am

SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass., Dec. 18, 2019 (GLOBE NEWSWIRE) -- Global Blood Therapeutics , Inc. (GBT) (NASDAQ: GBT) and Syros Pharmaceuticals, Inc. (NASDAQ: SYRS) today announced that they have entered into a collaboration to discover, develop and commercialize novel therapies for sickle cell disease (SCD) and beta thalassemia. Under the agreement, Syros will use its leading gene control platform to identify therapeutic targets and discover drugs that induce fetal hemoglobin, and GBT will receive an option to obtain an exclusive worldwide license to develop, manufacture and commercialize products resulting from the collaboration.

The discovery and development of novel therapeutic approaches to treat sickle cell disease has been a driving force for GBT since we were founded, said Ted W. Love, M.D., president and CEO of GBT. We believe that Syros approach to inducing fetal hemoglobin is one of the most promising ways to identify the next generation of therapies to treat sickle cell disease and beta thalassemia at a fundamental level upstream of serious complications such as organ damage, organ failure and early death. We will continue to seek the best scientific approaches to transform the treatment of these devastating lifelong diseases.

Using its gene control platform to elucidate mechanisms controlling gamma globin gene expression, Syros identified components of LRF (leukemia/lymphoma-related factor) and the NuRD (nucleosome remodeling and histone deacetylation) complex that could serve as potential targets to switch on the gamma globin gene, which is normally silenced a few months after birth. By turning on gamma globin expression, GBT and Syros aim to induce the production of fetal hemoglobin, which is known to exert protective effects on the red blood cells of patients with SCD and beta thalassemia and mitigate the clinical manifestation of these diseases.

We believe it is possible to provide a functional cure for patients with sickle cell disease or beta thalassemia by switching on the gamma globin gene with an oral medicine, said Nancy Simonian, M.D., CEO of Syros. Partnering with GBT, an established leader in sickle cell disease with proven research, development, manufacturing and commercialization capabilities, allows us to expand and accelerate our program, exploring multiple approaches in parallel with the aim of bringing much-needed new therapies to market for patients with sickle cell disease and beta thalassemia as quickly as possible.

Syros drug discovery program in SCD was highlighted recently in an oral presentation at the 61st American Society of Hematology (ASH) Annual Meeting, as well as in an ASH press briefing. In that presentation, Syros described its discovery of a fetal hemoglobin repressor that, when knocked down in primary cells and an erythroid cell line expressing adult hemoglobin, induced fetal hemoglobin in nearly 100% of cells and increased total fetal hemoglobin levels to 40%, exceeding levels that are associated with a functional cure in SCD patients.

Terms of the AgreementUnder the terms of the agreement, GBT will pay Syros $20 million upfront and fund up to $40 million in preclinical research for at least three years. Should GBT exercise its option under the agreement, Syros could receive up to $315 million in option exercise, development, regulatory, commercialization and sales-based milestones per product candidate and product resulting from the collaboration. Syros would also receive mid- to high-single digit royalties on sales of products resulting from the collaboration. In addition, Syros would have the option to co-promote the first product resulting from the collaboration in the United States.

About GBTGBT is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a p-selectin inhibitor in development to address pain crises associated with the disease. In addition, GBTs drug discovery teams are working on new targets to develop the next generation of treatments for SCD. To learn more, please visit http://www.gbt.com and follow the company on Twitter @GBT_news.

About Syros PharmaceuticalsSyros is redefining the power of small molecules to control the expression of genes. Based on its unique ability to elucidate regulatory regions of the genome, Syros aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches. Syros is advancing a robust pipeline of development candidates, including SY-1425, a first-in-class oral selective RAR agonist in a Phase 2 trial in a genomically defined subset of acute myeloid leukemia patients, and SY-5609, a highly selective and potent oral CDK7 inhibitor in investigational new drug application-enabling studies in cancer. Syros also has multiple preclinical and discovery programs in oncology and monogenic diseases, including sickle cell disease. For more information, visit http://www.syros.com and follow us on Twitter (@SyrosPharma) and LinkedIn.

Forward-Looking StatementsCertain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, including statements containing the words will, anticipates, plans, believes, forecast, estimates, expects and intends, or similar expressions. These forward-looking statements are based on the current expectations of GBT and Syros, and actual results could differ materially. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. GBT and Syros each intend these forward-looking statements, including statements regarding the ability of the parties to discover, develop and commercialize novel therapies for SCD and beta thalassemia under the collaboration, the scientific and therapeutic potential of Syros gene control platform and approach to inducing fetal hemoglobin, the exercise by GBT of its option under the collaboration agreement, the potential milestone payments and royalties due to Syros under the collaboration agreement, and Syros option to co-promote the first product resulting from the collaboration in the United States, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and GBT and Syros make this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect the current views of GBT and Syros about their respective plans, intentions, expectations, strategies and prospects, which are based on the information currently available to the companies and on assumptions the companies have made. Neither GBT nor Syros can give any assurance that the plans, intentions, expectations or strategies will be attained or achieved, and, furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond the control of GBT and Syros including, without limitation, the timing and progress of, and any data generated from, the parties research and development activities under the collaboration, and the amount and timing of resources devoted by each of the parties to activities under the collaboration, along with those risks set forth in GBT and Syros respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2018, and most recent Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in the companies subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, neither GBT nor Syros assumes any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information:

Global Blood Therapeutics (GBT)

MediaSteven Immergut650-410-3258media@gbt.com

InvestorsStephanie Yao650-741-7730investor@gbt.com

Syros Pharmaceuticals

MediaNaomi Aoki617-283-4298naoki@syros.com

InvestorsHannah Deresiewicz212-362-1200hannah.deresiewicz@sternir.com

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GBT and Syros Partner to Discover, Develop and Commercialize Novel Therapies for Sickle Cell Disease and Beta Thalassemia - BioSpace

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