Grey’s Anatomy: Jo Is Desperate for Family Without Stephanie Around – TV Guide

Now PlayingGrey's Anatomy: How Will Jo Manage Without Stephanie?

Poor Jo!

That's not a statement we use much in relation to Grey's Anatomy, but we have to admit that homegirl has had it rough the past couple of seasons. On top of losing her fiance, drama causing her to fall behind in the residents program and her coworker falling in love with her, Jo's (Camilla Luddington) best friend is now leaving Grey Sloan to find herself.

That leaves one lonely Jo running around the hospital, and that's pretty damn sad. Stephanie (Jerrika Hinton) was like a sister to Jo, Luddington told TV Guide at the Television Critics Association summer press tour. However, with Stephanie gone Jo will be looking for someone else to lean on.

Grey's Anatomy: Catherine Almost Sidelined Bailey Over Karev's Assault

"I think Jo is going to try and attempt to lean on Ben a bit this season," Luddington confessed. "Is it successful? I don't know. I think she's trying to pull anyone close to her and that's another resident...As for other women, I don't know yet. That'll be interesting."

See if Jo gets a new BFF when Grey's Anatomy returns for a two-hour premiere on Thursday, Sept. 28 at 8/7c on ABC.

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Grey's Anatomy: Jo Is Desperate for Family Without Stephanie Around - TV Guide

Is Sara Ramirez Returning to Grey’s Anatomy for Season 14? – SheKnows.com

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Could the upcoming season of Grey's Anatomy get any better? We've already received enough incredible casting news to completely blow our minds, and now there are rumors that Sara Ramirez could be returning to the hit show to reprise her role as Callie Torres.

More: Jesse Williams' Insta Is Making Us So Hungry for Grey's Anatomy

But don't hold your breath, Grey's fans. According to executive producer Debbie Allen, "there are no plans at the moment" for Ramirez to return to the series, even for a guest role, during Season 14.

"We love her and we miss her, [but] theres been no discussion of it," Allen added.

We probably shouldn't have gotten our hopes up. But from the moment we learned that Marika Dominczyk, who played Arizona's most recent girlfriend on the show, won't be returning for the upcoming season, we couldn't help but wonder who would pick up the pieces of newly single Arizona's broken heart. And who better than her old flame Callie? They were so great when they were together. We need them back together.

More: Using Only 9 Words, Meredith Just Destroyed Fans During the Grey's Anatomy Finale

Ramirez starred in the show up until Season 12, when she was written out because Callie announced she was relocating to take a job in New York.

"Im deeply grateful to have spent the last 10 years with my family at Greys Anatomy and ABC, but for now, Im taking some welcome time off," Ramirez said at the time. "[Series creator] Shonda [Rhimes has] been so incredible to work for, and we will definitely continue our conversations."

More: Grey's Anatomy's Finale Had a Sad Goodbye but These Deaths Were Way Worse

So far, though, those conversations haven't continued, at least to the point of getting Ramirez back on the show. Fans will just have to keep waiting and hoping, we guess.

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Is Sara Ramirez Returning to Grey's Anatomy for Season 14? - SheKnows.com

Self-driving cars still can’t mimic the most natural human behavior – Quartz

What do you need to build a self-driving car? Roboticists and computer scientists have generally settled on similar requirements. Your autonomous vehicle needs to know where the boundaries of the road are. It needs to be able to steer the car and hit the brakes. It needs to know the speed limit, be able to read street signs, and detect if a traffic light is red or green. It needs to be able to react quickly to unexpected objects in its path, and it gets extra points if it knows where it is on a map.

All of those skills are important and necessary. But by building from a list of technical requirements, researchers neglect the single most important part of real-world driving: our intuition. Using it to determine the motivations of those around us is something humans are so effortlessly good at that its hard to even notice were doing it, nonetheless program for it.

A self-driving car currently lacks the ability to look at a personwhether theyre walking, driving a car, or riding a bikeand know what theyre thinking. These instantaneous human judgments are vital to our safety when were drivingand to that of others on the road, too.

As the CTO and cofounder of Perceptive Automata, an autonomous-vehicle software company started by Harvard neuroscientists and computer scientists, I wanted to see how often humans make these kinds of subconscious calls on the road. I took a camera out to a calm intersection near my former lab at Harvard with no traffic signals. It is not by any stretch of the imagination as congested or difficult as an intersection in downtown Boston, let alone Manhattan or Mexico City. But in 30 seconds of video, it is still possible to count more than 45 instances of one person intuiting whats in the mind of another. These non-verbal, split-second intuitions could be that person is not going to yield, that person doesnt know Im here, or that person wouldnt jaywalk while walking a dog. Is that bicyclist going to turn left or stop? Is that pedestrian going to take advantage of their right-of-way and cross? These judgments happen instantaneously, just watch.

We have lots of empirical evidence that humans are incredibly good at intuiting the intentions of others. The Sally-Anne task is a classic psychology experiment. Subjectsusually childrenwatch a researcher acting out a scene with dolls. A doll named Sally hides a marble in a covered basket. Sally leaves the room. While Sally is gone, a second dollAnnesecretly moves the marble out of the basket and into a closed box. When the first doll comes back, children are asked where she will look for the marble. Its easy to say, Well, of course shell still look in the basket, as Sally couldnt have known that the marble had moved while she was gone. But that of course is hiding an immensely sophisticated model. Children have to know not only that Sally is aware of some things and not of others, but that her awareness only updates when she is able to pay attention to something. They also have to know that her mental state is persistent, even when she leaves the room and comes back. This task has been repeated many times in labs around the world, and is part of the standard toolkit researchers use to understand if somebodys social intuitions are intact.

The ability to predict the mental state of others is so innate that we even apply it to distinctly non-human objects. The Heider-Simel experiment shows how were prone to ascribe perceived intent even to simple geometric shapes. In this famous study, a film shows two triangles and a circle moving around the screen. With essentially no exceptions, most people construct and elaborate narrative about the goals and interactions of the geometric shapes: One is a villain, one a protector, the third a victim who grows courageous and saves the dayall these mental states and narratives just from looking at geometric shapes moving about. In the psychological literature, this is called an impoverished stimulus.

Our interactions with people using the road are an example of an impoverished stimulus, too. We only see a pedestrian for a few hundred milliseconds before we have to decide how to react to them. We see a car edging slightly into a lane for a half second and have to decide whether to yield to them. We catch a fleeting glimpse of a cyclist and judge whether they know were making a right turn. These kinds of interactions are constant, and they are at the very core of driving safely and considerately.

And computers, so far, are hopeless at navigating them.

The perils of lacking an intuition for state of mind are already evident. In the first at-fault crash of a self-driving vehicle, a Google self-driving car in Mountain View incorrectly assumed that a bus driver would yield to it, misunderstanding both the urgency and the flexibility of a human driver trying to get around a stopped vehicle. In another crash, a self-driving Uber in Arizona was hit by a turning driver who expected that any oncoming vehicles would notice the adjacent lanes of traffic had slowed down and adjust its expectations of how turning drivers would behave.

Why are computers so bad at this task of mind reading if its so easy for people? This circumstance comes up so often in AI development that it has a name: Moravecs Paradox. The tasks that are easiest for people are often the ones that are the hardest for computers. Were least aware of what our minds do best, said the late AI pioneer Marvin Minsky. Were more aware of simple processes that dont work well than of complex ones that work flawlessly.

So how do you design an algorithm to perform a task if you cant say with any certainty what the task entails?

The usual solution is to define the task as simply as possible and use what are called deep-learning algorithms that can learn from vast quantities of data. For example, when given a sufficient number of pictures of trees (and pictures of things that are not trees), these computer programs can do a very good job of identifying a tree. If you boil a problem down to either proving or disproving an unambiguous fact about the worldthere is a tree there, or there is notalgorithms can do a pretty good job.

The only way to solve these problems is to deeply understand human behavior by characterizing it carefully using the techniques of behavioral science.But what to do about problems where basic facts about the world are neither simple nor accessible? Humans can make surprisingly accurate judgments about other humans because we have an immensely sophisticated set of internal models for how those around us behave. But those models are hidden from scrutiny, hidden in the black boxes of our minds. How do you label images with the contents of somebodys constantly fluid and mostly nonsensical inner monologue?

The only way to solve these problems is to deeply understand human behaviornot just by reverse-engineering it, but by characterizing it carefully and comprehensively using the techniques of behavioral science. Humans are immensely capable but have opaque internal mechanisms. We need to use the techniques of human behavioral research in order to build computer-vision models that are trained to capture the nuances and subtleties of human responses to the world instead of trying to guess what our internal model of the world looks like.

First, we need to work out how humans worksecond comes training the machines. Only with a rich, deep characterization of the quirks and foibles of human ability can we know enough about the problem were trying to solve in order to build computer models that can solve it. By using humans as the model for ideal performance, we are able to gain traction on these difficult tasks and find a meaningful solution to this intuition problem.

And we need to solve it. If self-driving cars are going to achieve their promise as a revolution in urban transportationdelivering reduced emissions, better mobility, and safer streetsthey will have to exist on a level playing field with the humans who already use those roads. They will have to be good citizens, not only skilled at avoiding at-fault accidents, but able to drive in such a way that their behavior is expected, comprehensible, and clear to other vehicles drivers and the pedestrians and cyclists sharing space with them.

Follow Sam on Twitter. Learn how to write for Quartz Ideas. We welcome your comments at ideas@qz.com.

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Self-driving cars still can't mimic the most natural human behavior - Quartz

Are you responsible for your spouse’s behavior? – The Standard

"Mom, can you do something, please..."

Jael's voice trailed off as she spoke to her mother on phone. She started sobbing even before she hung up.

Life had not been kind to Jael. She felt older than her 42 years of age. Where did she go wrong?

She closed her eyes and allowed her mind to wander. She grew up in an average family. Her mother was a teacher while her father was a businessman. Her father was now deceased and her mother - who had already retired from her teaching job - was in charge of the family businesses.

A Happy Marriage

Jael's marriage was full of ups and downs. She met Mike when still at the university and they started dating almost immediately. He was really charming and treated her like a queen. They moved in together a few months after her graduation and legalized their union less than a year later.

Mike treated her really well, taking her out for surprise dinners and occasionally even taking her away for weekends to exotic locations in different parts of the country. This did not stop even after the children came. The family lived quite well and life was good.Mike and Jael were blessed with three children; two girls and one boy.

All No Longer Well?

The first indication that all was not well in their lives happened after 15 years of marriage. There were many times that Mike's phone would ring and he would not pick the calls. Then, Mike changed his telephone line without any explanation. When he told Jael that he had a new cell phone number, she was surprised. She asked him why he would change his number yet most of his contacts did not have the new number. He could not explain but told her that it was no big deal.

Things just did not look the same. Mike's circles had changed. He no longer seemed to keep the same company like before. He had also become secretive. Suddenly, Jael realized that her husband was slowly becoming a stranger. She started wondering whether he was in an extra-marital relationship that he was trying to hide from her.

It did not take long for her to fit the jigsaw puzzle. She started receiving telephone calls from people who were known to both of them, requesting her to tell Mike to switch on his phone for they were trying to get in touch with him. She would tell him but he would not comment.

With time, the message in the calls changed to telling her to let Mike know that they were expecting the payments as agreed. When she would give Mike the messages he would not comment.

Trouble With The Law

It was not until the day that a colleague from Mike's office called Jael to inform her that Mike had been arrested. That was the beginning of a long journey of turmoil for Jael and her family. The family got auctioned twice within a space of one year and Mike got arrested a number of times. Their lives turned into a nightmare.

It was a rude awakening to Jael to discover that a lot of what she believed about Mike was fake, including his academic credentials. He even had a fake identity and some people knew him by names she did not know. In short, Mike's life was largely a lie and he had misrepresented himself to many different people mainly to extort money from the unsuspecting people.

The first few times her family got into trouble, her mother and her siblings put some cash together and bailed her family out. They helped out a number of times till it dawned on them that Mike's problems were beyond what they could handle.

Jael would call her family members and beg them to help but they totally refused to get involved. She eventually surrendered to fate. Mike was found guilty of a number of crimes and sentenced to prison.

Rebuilding

Jael started to rebuild her life from humble beginnings. She moved to a cheaper house that she could afford to pay for. She struggled to keep the children in school and often paid school fees in installments. The high life they had lived for years gradually became a distant dream.

The children struggled to adjust to their new status and it was initially difficult for Jael to cope with the backlash. They got angry, became rebellious, got into trouble in school and in the neighborhood and disobeyed her. It was a very difficult road for her family but she took it one day at a time.

A man is the head of his household. He provides direction and leadership for his family. To learn more about how to effectively lead a family, here are useful tipssecure-your-family's-future-through-strong-leadership.

We often like to quote about the two becoming one in marriage. So, now that you are married, do you take responsibility for the behavior of your spouse, whom you consider to be your better half?

Two people meet when they are already adults, fall in love and decide to get married. In a few exceptional cases, couples have known each other from a young age, sometimes from childhood.

Should You Take Responsibility For Your Spouse's Behavior?

You are married probably to the love of your life. Is it your fault that your spouse is cheating on you, disrespects or abuses you or probably engages in criminal activities? Is it your behavior that taught him or her to be that way, to treat you that way or to have a certain attitude towards family responsibilities?

Human behavior refers to the sum total of actions and emotions associated with a human being. It is complicated. For those who think that everything human behavior is simply a matter of good or bad choices, that is oversimplifying a complex topic.

So, What Shapes Human Behavior?

1.Genetics

Genetics refers to the traits we inherit from our parents. Genetic influence on behavior has been studied using identical twins who were adopted by different families at birth such that besides inheritance, everything in their upbringing environment was different. Siblings who were adopted sometimes discover each other as adults only to find out that they have a lot of similarities and not just in terms of physical appearance.

2.Social Norms

An individual's behavior is shaped by the group one is a part of. That is why people from the same cultural or religious group have similar attitudes and practices such as what they consider an acceptable dressing code. There is warmth in a sense of belonging and human beings make effort to fit in or to find acceptance, even when the practices of the group might be destructive to them. Norms also govern families.

3.Attitudes

Attitudes have roots in past experiences and conditioning. An individual associates certain things with certain experiences. For example, a child associates going out to the park with pleasure and going to the dentist with pain. Changing one's attitude takes a conscious effort to question the norms. Negative attitudes can be changed by evaluating reasons behind the attitudes.

4.Mind and Body

Behavior is affected by what is going on in our bodies. Hormonal changes at certain periods of time such as teenage, pregnancy, during certain times in women's monthly cycle and during menopause; affect behavior.

Nutrition also affects behavior and that is the genesis of the saying 'a hungry man is an angry man. Hunger or having a brain that is starved of nutrients affects mood negatively and can make one quick to anger. Conditions such as having a brain tumor in certain areas of the brain or having low levels of feel-good neurotransmitters in the brain can affect mood negatively.

The mind and body are connected and influence each other. That is why we talk of 'a healthy mind in a healthy body'.

5.Coping Mechanisms

All human beings face difficulties and challenges from time to time but some cope better than others. Coping mechanisms are dependent on one's overall personality and lessons learned in life. There are people who train themselves in coping mechanisms such breathing in and out before reacting when provoked or engaging in vigorous physical activity when angry. Coping mechanisms can be trained as part of upbringing, through therapy or one can learn them independently.

When two people get married, the behavior of each of them is already fully established; it is not taught by the spouse. Much as one can do their best to influence the spouse positively, there is a lot that is already deeply entrenched in the individual that might not be possible to change, unless through therapy.

Achieving behavior change takes work; it is not handed to anyone on a silver platter. It, therefore, depends on whether the individual is ready to pay the price of change or not. People do not change themselves because someone else told them to change.

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Are you responsible for your spouse's behavior? - The Standard

New findings on brain functional connectivity may lend insights into mental disorders – Medical Xpress

Ongoing advances in understanding the functional connections within the brain are producing exciting insights into how the brain circuits function together to support human behaviorand may lead to new discoveries in the development and treatment of psychiatric disorders, according to a review and update in the Harvard Review of Psychiatry.

Advanced neuroimaging techniques provide a new basis for studying circuit-level abnormalities in psychiatric disorders, according to the special perspectives article by Deanna M. Barch, PhD, of Washington University in St. Louis. She writes, "These advances have provided the basis for recent efforts to develop a more complex understanding of the function of brain circuits in health and of their relationship to behaviorproviding, in turn, a foundation for our understanding of how disruptions in such circuits contribute to the development of psychiatric disorders."

Functional Connectivity Data Point to New Understanding of Psychopathology

In recent years, large-scale research projects including the Human Connectome Project (HCP) have focused on defining and mapping the functional connections of the brain. The result is an extensive body of new evidence on functional connectivity and its relationship to human behavior.

In her article, Dr. Barch focuses on a technique called resting-state functional connectivity MRI (rsfcMRI), which measures how spontaneous fluctuations in blood oxygen level-dependent signals are coordinated across the brain. Analysis of rsfcMRI and other data in large numbers of subjects from the HCP will provide new insights into a wide range of psychiatric disorders, such as depression and anxiety, substance use, and cognitive impairment.

Recent studies have found that spontaneous activity from networks of regions across the brain are highly correlated even at rest (that is, when the person is not performing a specifically targeted task). This "resting state" activity may consume around 20 percent of the body's total energyeven though the brain is only two percent of total body mass, according to Dr. Barch. "Ongoing resting-state activity may provide a critical and rich source of disease-relate variability."

One key question is what constitutes the "regions" that make up the neural circuits of the brain. Recent rsfcMRI mapping studies have identified between 180 and 356 different brain regions, including many common regions that can be mapped across individuals. Future studies will look at whether these regions differ in shape, size, or location in people with psychiatric disordersand whether these differences contribute to changes in the formation and function of brain circuits.

Some brain networks identified by rsfcMRI may play important roles in the functions and processes commonly impaired in psychiatric disorders. These include networks involved in cognitive (thinking) function, attention to internal emotional states, and the "salience" of events in the environment. Many questions remain as to how these brain networks are related to behavior in general, and to psychiatric disorders in particular.

Some researchers are using HCP data to study behavioral factors relevant to psychiatric issues, including cognitive function, mood, emotions, and substance use/abuse. Other studies are looking for rsfcMRI patterns related to individual differences in depression or anxiety, and their connections to various brain networks.

Dr. Barch's research focuses on brain networks affecting the relationship between cognitive function and "psychotic-like" experiences. She notes that work on individual differences in functional connectivity in the HCP dataset is just getting startedthe full HCP dataset was made publicly available in the spring of 2017.

"The hope is that these analyses will shed new light on how behavior of many different forms is related to functional brain connectivity, ultimately providing a new window for understanding psychopathology," Dr. Barch writes. Continued studies of the relationships between brain circuitry and behavior might eventually lead to new therapeutic targets and new approaches to treatment monitoring and selection for patients with psychiatric disorders.

Explore further: Manipulating brain network to change cognitive functions: New breakthrough in neuroscience

More information: Deanna M. Barch. Resting-State Functional Connectivity in the Human Connectome Project, Harvard Review of Psychiatry (2017). DOI: 10.1097/HRP.0000000000000166

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New findings on brain functional connectivity may lend insights into mental disorders - Medical Xpress

Grabit’s Robots Produce Nike Shoes 20 Times Faster Than Humans Do – The Merkle

It is no secret most robots will be far better at making products and goods thantheir human counterparts ever will be. According to Grabit, the companysline of robots is capable of working at 20 times the pace of anaverage human. These robots are designed to build pairs of Nike shoes. Flooding the market with the finished product may help to push the shoesaverage price down by quite a bit. It is one of those developments people will both love and hate at the same time.

Very few people consider how much work goes into the process of putting a pair of shoes together. The amount of labor required for this specific purpose should not be overlooked. The upper part of the shoe which sits on top of your foot is actually the most laborious task ofall to complete. It is not comprised of one single piece of material. Humans often have to put together a few dozen individual pieces in order to create this part of the shoe. Up until now, no robot hadbeen able to produceadequate results whenputting this part together.

Grabit claims that has now changed. The company has built a robot which is capable of fully assembling pairs of Nike shoesquickly. Considering how Nike, Inc. invested millions in this company, it is about time those efforts pay off. It is worth noting how the robots rely on static electricity known as electroadhesion to help manipulate objects in unique ways. This allows the robots to assemble every single part of a shoe with relative ease. It does so at 20 times the pace of a human worker, which is both amazing and terrifying.

So far, a few Nike facilities have been equipped with Grabit robots to fully test their performance over time. It is expected around 12 of these machines will be operating across both Mexico and China before December 31st of this year. Thiswould certainly allow Nike to shake up itsmanufacturing process quite a bit and bring it closer to itsmajor consumer market. If this trial were successful, it could mean positive things for the industrys negative association with child labor as well.

Automation is coming to the manufacturing sector. So far, no major companies have deployed such technology on any sizeable scale, though. Robotic arms have been the main area of focus for the time being, although other technologies are being considered as well. Entrusting robots with more meticulous work is a big gamble by Nike, but so far, the companysefforts are paying off. Only time will tell whether or not their gut feeling was the right one, though.

Grabits robots do not mimic human behavior. They use flat pads of electrodes which create an electrical field adhering to virtually any surface one can think of. This is very different from most robotic hand-oriented projects in the industry right now. It is more likehow one would expect robots to behave, rather than an imitation of human workforce. It does not appear the company faces any major competition right now, which makes them rather unique for the time being.

Moreover, Grabits robots can work together with human operators, which is another big selling point. The software decides how the various pieces shouldbe stacked, and lights up positions for the human partner to set things down. The system currently requiresone human employee to monitor one machine per shift, which should improve overall productivity by up to 2,000%. This is a very interesting development that shows that not all robots are designed to take human jobs.

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Grabit's Robots Produce Nike Shoes 20 Times Faster Than Humans Do - The Merkle

Human Stem Cells Repair Spinal Cord Injuries In Mice At Human Biological Rate – IFLScience

Researchers at the University of California San Diego and at the San Diego Veterans Administration Medical Center have shown that human neural stem cells (NSCs) grafted onto the spinal cord injuries of mice produced a functional recovery after one year. The team has shown that the NSCs continue to grow slowly and steadily even18 months after implantation.

The study is published in the Journal of Clinical Investigation and set out to answer how long it would take for the cells to mature inside the rodents. Mice and humans have a very different pace when it comes to cell biology.

"The NSCs retained an intrinsic human rate of maturation despite being placed in a traumatic rodent environment," lead author Professor Paul Lu said in a statement. "That's a finding of great importance in planning for human clinical trials."

The researchers were worried that the animal model would not reflect the how this approach might in the future work in humans. For example, pregnancies last 21 days in mice and 280 days in humans. And the weight of a toddlers brain is comparable with that of a 20-day-old mouse.

"Most NSC grafting studies have been short-term, measuring survival times in weeks to a few months," added co-author Professor Mark Tuszynski. "That's not enough time to fully measure the growth and maturation rate of human NSCs or what changes might occur farther out from the original grafting. These are important considerations, not just for the basic science of stem cell biology, but for the practical design of translational human trials using NSCs for spinal cord injuries."

The researchers report that the cells maintained their natural maturation pace even though they were in a foreign environment. Thats why it took several months for the lesions to begin healing. The scientists noted that improvement in the mice mobility only happened after more mature nerve cells formed. As the grafts aged, they displayed the expected pruning and cell redistribution activities that help the development of fewer but more mature cells.

"The bottom line is that clinical outcome measures for future trials need to be focused on long time points after grafting," said Tuszynski. "We need to take into account the prolonged developmental biology of neural stem cells. Success, it would seem, will take time."

The team noticed that none of the implanted NSCs migrated from the graft but some supportive astrocytes cells did, which could be a potential safety concern. No tumors or anomalous formation were created by these cells and modified grafting should fix the problem. A better understanding of this approach, so that the results can be carefully assessed, is required before we can even think to try it on humans.

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Human Stem Cells Repair Spinal Cord Injuries In Mice At Human Biological Rate - IFLScience

‘Transformative’ cancer treatment: FDA approves gene therapy that functions as a ‘living drug’ – Los Angeles Times

In a step that heralds a new era in cancer treatment, the U.S. Food and Drug Administration said Wednesday it has approved a form of gene therapy that is highly effective at fighting an aggressive form of leukemia in young patients with no other options.

The treatment, to be marketed under the name Kymriah, is neither a pill nor an injection, but a personalized medicine service that functions as a living drug. Patients would have their bodys own disease-fighting T cells fortified and multiplied in a lab, then get the cells back to help them fight their cancer.

In clinical trials of 88 patients with a relapsing or treatment-resistant form of acute lymphoblastic leukemia, 73 went into remission after receiving the experimental treatment.

FDA Commissioner Scott Gottlieb, himself a survivor of blood cancer, predicted that this new approach to cancer treatment will change the face of modern medicine.

Cancer researchers and physicians outside the agency shared Gottliebs enthusiasm.

Dr. Crystal L. Mackall, associate director of Stanford Universitys Cancer Institute, called Kymriah a transformative therapy. It represents an entirely new class of cancer therapies that holds promise for all cancer patients.

Acute lymphoblastic leukemiais the most common form of pediatric cancer, affecting some 3,000 children and young adults yearly in the United States. Though it is considered highly curable in most patients, about 600 each year either do not respond to chemotherapy or see their leukemia return after an initial round of successful treatment.

Those patients dont make it none of them do, said Dr. Stephan A. Grupp, director of the cancer immunotherapy program at Childrens Hospital of Philadelphia, who administered the first course of Kymriah five years ago when it was an experimental treatment called CTL019.

That initial patient, 7-year-old Emily Whitehead of Philipsburg, Pa., saw her leukemia remit completely within three weeks of getting the treatment. Now 12, she was among those calling on the FDA to approve Kymriah for other patients like her.

Certainly for blood cancers, this is a game-changer, Grupp said. Adapting this therapy for patients with solid tumors, he said, will be the work of the next five years.

The new approach was designed to fight some of the most stubborn cancers by giving the bodys immune system a very specific assist.

It starts by harvesting a cancer patients T cells, the warriors of the immune system. The cells are delivered to a specialized lab where scientists alter their DNA, essentially reprogramming them to target cancer cells. These reengineered cells are called chimeric antigen receptor T cells, or CAR-T cells.

The new and improved cells are copied millions of times before theyre sent back to the patient. Once infused into the bloodstream, the CAR-T cells are much better equipped to hunt down and kill cancer cells, wherever they may hide.

Novartis, the company that developed Kymriah, intends to have 32 certified treatment centers up and running by the end of 2018. Patients up to the age of 25 would go to one of these centers to have their T cells harvested and later reintroduced in their modified form.

The cells themselves will be genetically engineered at a Novartis manufacturing facility in Morris Plains, N.J.

Kymriah is the first CAR-T treatment to come before the FDA, but it wont be the last. No fewer than 76 CAR-T treatments are currently under review at the FDA, and Gottlieb predicted that other approvals would follow.

Therapies that would operate in similar ways engineering the immune systems T cells to fight disease more effectively are under investigation for a host of other conditions, including HIV/AIDS, genetic and autoimmune disorders and other forms of cancer.

Todays FDA ruling is a milestone, said Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center in Seattle. This is just the first of what will soon be many new immunotherapy-based treatments for a variety of cancers.

Novartis, the Swiss pharmaceutical company that is gearing up to provide Kymriah to as many as 600 patients a year, said it would charge $475,000 for the treatment.

Novartis representatives said they calculated a cost-effective price for the therapy that fell between $600,000 and $750,000. But the company chose instead to charge a price that it said would cover costs, and to introduce a novel approach to billing. Chief Executive Joseph Jimenez said the company will not charge hospitals for the therapy if the patient does not fully respond in a given period of time.

The company also said it will launch a patient assistance program for those who are uninsured or underinsured, and provide some travel assistance for patients and caregivers seeking the treatment.

Gottlieb touted Kymriahs approval as a turning point for the FDA as well. Novartis application for Kymriah came just seven months ago. The agency tagged the application with two designations that ensured its speedy review.

First proposed in 1972, the idea of correcting or enhancing genes to treat disease has a history buoyed by promise but also buffeted by failures. With recent advances in genomic medicine, cell biology and genetic engineering, efforts to locate and edit the genes and cells that play a key role in disease have injected new hope for such treatments.

Gene and cell therapies that target the immune system for enhancement have been particularly promising. They do, however, come with risks specifically, that the activation of immune cells will run amok, sparking reactions ranging from rash and itching to fever and flu-like symptoms that can lead to death.

In approving Kymriah, the FDA warned that it has the potential to cause severe side effects, including cytokine release syndrome, an overreaction to the activation and proliferation of immune cells that causes high fever and flu-like symptoms, and neurological events. Both can be life-threatening. Kymriah can also cause serious infections, low blood pressure, acute kidney injury, fever and low oxygen levels.

The FDA called for continuing safety studies of the new therapy.

melissa.healy@latimes.com

@LATMelissaHealy

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'Transformative' cancer treatment: FDA approves gene therapy that functions as a 'living drug' - Los Angeles Times

FDA cracks down on stem-cell clinics selling unapproved treatments – 89.3 KPCC

The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb said in a statement Monday.

The FDA has taken action against clinics in California and Florida.

The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for "marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements."

The clinic is one of many around the country that claim to use stem cells derived from a person's own fat to treat a variety of conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says.

The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration.

The FDA also said it has taken "decisive action" to "prevent the use of a potentially dangerous and unproven treatment" offered by StemImmune Inc. of San Diego, Calif., and administered to patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif.

As part of that action, the U.S. Marshals Service seized five vials of live vaccinia virus vaccine that is supposed to be reserved for people at high risk for smallpox but was being used as part of a stem-cell treatment for cancer, according to the FDA. "The unproven and potentially dangerous treatment was being injected intravenously and directly into patients' tumors," according to an FDA statement.

Smallpox essentially has been eradicated from the planet, but samples are kept in reserve in the U.S. and Russia, and vaccines are kept on hand as a result.

But Elliot Lander, medical director of the California Stem Cell Treatment Centers, denounced the FDA's actions in an interview with Shots.

"I think it's egregious," Lander says. "I think they made a mistake. I'm really baffled by this."

While his clinics do charge some patients for treatments that use stem cells derived from fat, Lander says, none of the cancer patients were charged and the treatments were administered as part of a carefully designed research study.

"Nobody was charged a single penny," Lander says. "We're just trying to move the field forward."

In a written statement, U.S. Stem Cell also defended its activities.

"The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration," according to the statement.

"We have helped thousands of patients harness their own healing potential," the statement says. "It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

But stem-cell researchers praised the FDA's actions.

"This is spectacular," says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. "This is the right thing to do."

Daley praised the FDA's promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on "snake-oil salesmen" marketing unproven treatments.

Stem-cell research is "a major revolution in medicine. It's bound to ultimately deliver cures," Daley says. "But it's so early in the field," he adds. "Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven't been proven to work and may be unsafe."

Others agreed.

"I see this is a major, positive step by the FDA," says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics.

"I'm hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell "treatments" that may not be real treatments," Knoepfler says.

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FDA cracks down on stem-cell clinics selling unapproved treatments - 89.3 KPCC

ISU researchers receive $2.98 million grant – Iowa State Daily

Iowa State researchers were awarded a four year, $2.98 million grant Tuesday from the National Institutes of Health.

The research will work todevelop innovative technology to search the genome of zebrafish for genes leading to advances in human health.

By identifying specific genes related to disease and switching them off and on, the researchers hope their findings could lead to new treatments for health issues such as cancer, vascular disease and neurological disorders.

We need to determine if a gene is curative, said Jeff Essner, professor ofgenetics, development and cell biologyand research team member. Were hoping to develop a toolbox that will allow us to identify genes in zebrafish, and ultimately in humans, that can be targeted with therapy to cure various ailments.

Zebrafish are small, freshwater fish.Zebrafish are ideal for this kind of genetics work because their embryos are fertilized outside the body of the mother.

The embryos are also transparent, making them easy for scientists to collect and target with the gene-editing technology.

Zebrafish share many genes with humans which lead to disease, said Maura McGrail,professor ofgenetics, development and cell biologyand another research team member.

The researchers can activate fluorescent genes in the zebrafish to cause certain tissues to glow.

Essner said this effect allows the researchers a direct way to confirm the gene-editing technology is working as they intend.

The team will also includeDrena Dobbs, a university professor of genetics, development and cell biology. They will also work withKarl Clark and Stephen Ekker at the Mayo Clinic in Rochester, Minnesota, who are conducting similar gene editing research in cultured human cells.

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ISU researchers receive $2.98 million grant - Iowa State Daily