StemCell Therapy

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Three-year-old Ipek Kuzu has an extremely rare genetic mutation that disrupts a protein needed for DNA repair, causing the loss of brain cells. Now shes become only the second person in the world to receive a customized antisense oligonucleotide drug designed to compensate for the DNA mistake by allowing her cells to splice together a functional version of the protein. The drug took Boston-based pediatrician and geneticist Tim Yu only months to create, heralding a new era of individualized genomic medicine. But it cost $2 million to manufacture and testleading to questions about how soon hyper-personalized treatments for rare genetic disorders can be made accessible and affordable. Journalist Erika Check Hayden got to know the Kuzu family, and in this episode she chronicles Ipeks journey, with help from Ipeks father Mehmet and Technology Review biomedicine editor Antonio Regalado.

Show notes and links:

If DNA is like software, can we just fix the code?, from the March/April 2020 print issue, p. 46

Hyper-personalized medicine, from the March/April 2020 print issue, p. 18

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Two sick children and a $1.5 million bill: One family's race for a gene therapy cure, from the November/December 2018 print issue, October 23, 2018

Episode Transcript

Audio ID: This is MIT Technology Review.

Mehmet Kuzu: Around five to six months, they said she has something called ataxia telangectasia. And they said this doesnt have any cure. The initial days were very tough. We were crying all the time. So then after a while, we started investigating what can be done.

Wade Roush: Mehmet Kuzus three-year-old daughter, Ipek, has a rare genetic mutation that could end her life by age 25. But now shes getting a so-called antisense drug that her doctors engineered specifically for her. Which makes Ipek one of the first patients being swept up in a new wave of hyperpersonalized medicine. Journalist Erika Check Hayden wrote about the Kuzu family in the latest issue of Technology Review. And today, she helps us understand where this breakthrough came from, and how soon it might be scaled up. Im Wade Roush, and this is Deep Tech.

[Theme music]

Were right at the beginning of a revolution in individualized genomic medicine. And if you want to know what that revolution sounds like, this is a good place to start.

[Sound of Illumina sequencing machines]

Thats one of the hundreds of high-speed gene sequencing machines at the Broad Institute of MIT and Harvard. Here at the Broads genomics platform in Cambridge there are so many of these machines that the institute can read the equivalent of 30 whole human genomes every 10 minutes.

There arent a lot of research centers with that kind of power. But in many places around the world its now possible to scan a babys full genome for just a few hundred dollars, and locate DNA coding errors that can cause rare conditions like ataxia telangectasia.

Thats how doctors diagnosed Ipek Kuzu when she was just six months old. The mistake in her DNA means her cells cant make a protein called ATM thats essential for DNA repair. Over the long run that causes the loss of brain cells, which means Ipek has some trouble walking and doesnt talk as much as a typical three-year-old.

Today Ipek is receiving an antisense drug made just for her. Its designed to compensate for the DNA mistake and restore production of ATM. Which makes her only the second person in the world to get this kind of treatment. The first was another little girl named Mila Makovec. She has different genetic disorder called Batten disease that causes blindness, seizures, and other neurodegenerative problems. And Mila got her own customized antisense drug starting in 2018.

But to understand how her doctors came up with these two medicines, and why this whole field of hyperpersonalized medicine is so hot that the editors of Technology Review decided to put it on this years list of 10 breakthrough technologies, we first have to jump back a few years, to 2016.

[CNBC Squawk Box news clip]

CNBC male anchor: Ionis Pharmaceuticals, in pre-market trading, is higher. The FDA has approved a drug called Spinraza. Spinraza.

CNBC female anchor: Its not Spine-raza?

CNBC male anchor: Maybe it is. Because its for spinal muscular atrophy. Its the first drug approved to treat the rare and fatal disease.

Wade Roush: Spinal muscular atrophy affects about 1 in 10,000 babies. So its not nearly as rare as Batten Disease or ataxia telangectasia. But Spinraza is literally the key to all of the more recent work to make customized antisense drugs for Mila and Ipek. So lets take a minute to go over how it works.

What made Spinraza a big deal is that it was one of the first successful medicines made using an antisense oligonucleotide. In other words, a customized strand of RNA.

Antonio Regalado: If you can imagine, inside a cell, there's the DNA.

Wade Roush: This is Antonio Regalado, the editor for biomedicine at Technology Review.

Antonio Regalado: And it kind of sends out these messages into the nucleus made of RNA and those are used as the templates to make proteins. And so antisense is a drug that acts at the level of RNA. They're going to stick to that RNA message and they could block it.

Wade Roush: Keep it from being translated.

Antonio Regalado: Keep it from being translated, or modify the translation in some fashion.

Wade Roush: In the cells of healthy people, theres a protein called SMN that helps motor neurons survive and grow. A gene called SMN1 carries the instructions for making that protein, and people with spinal muscular atrophy have a mutation that disables that gene. But it just so happens that human DNA also contains a second copy of the gene, called SMN2. This second copy is typically inactive, thanks to a small error that keeps the RNA message from being spliced together into a proper template. The Spinraza molecule contains a short segment of antisense RNA that prevents the splicing error. And that allows the body to start making the motor neuron protein.

Ionis Pharmaceuticals is the company that makes Spinraza, and they put a lot of work into figuring out how to get their molecule into cells in the brain and the nervous system, where it can do its work.

Antonio Regalado: And they finally mastered it and came up with pretty much kind of a miracle drug for one of these rare brain diseases that affects kids, spinal muscular atrophy. And so from that example, people then said, well, why can't we use antisense for other diseases that are similar?

And what we learned was that there was a doctor in Boston named Timothy Yu, who was an expert in sequencing genomes of sick children. And there was one girl named Mila Makovec. And her parents had come to him. He'd sequenced the genome. And then he just realized, I don't have to stop here. Once I've identified this defect, I don't have to stop. I could potentially make a drug. And so that's exactly what he did.

Wade Roush: It turned out that Milas disease was caused by a splicing error very similar to the one that causes spinal muscular atrophy, except that in Milas case it disrupts a different protein called CLN7. Tim Yus idea was to take the backbone of the Spinraza molecule and attach a customized strand of antisense RNA. With this new business end, so to speak, the drug would enable Milas cells to start making functional copies of the CLN7 protein.

Antonio Regalado: That was probably at that point just the clearest, starkest, most stunning example of this hyper personalized medicine. Because in this case, it was really for one person. So we were very interested in this phenomenon, because it's a reflection of what technology can do. And then in the middle of last year, a pretty prominent journalist, Erika Check Hayden, came to us and she was also interested and wanted to do some work to find the cases, find the families and write more stories about it. And as it developed, we decided, well, let's put this on our list of breakthrough technologies, because it really is. And so Erika ended up writing the piece and she did a lot of work to find the patients. One of the great things she did was to find this Kuzu family, which happens to be right here in Cambridge.

Wade Roush: Erika, could you introduce yourself and tell us a little bit about you?

Erika Check Hayden: Sure. My name is Erika Check Hayden. I'm a journalist based in San Francisco. And I also run the science communication program at the University of California, Santa Cruz.

Wade Roush: When you set out to start reporting this piece, did you feel like it was important to go beyond the first sort of headline-making case of Mila Makovec and look for additional patients who were going through this process to see how broadly applicable the whole idea is?

Erika Check Hayden: I do think that while people have been very impressed by Mila's case and by the drug that Tim Yu made for her, which is called milasen, I think there's also been this question of are we gonna be able to do this for other patients? And if so, you know, who is going to be treatable via this method? And so if I'm going out and finding other families that are hopefully replicating that success, I think is a really important statement about how impactful this approach might eventually be.

Wade Roush: So this is where the Kuzu family comes in. So could you tell us a little bit about them and how you got in touch with them?

Erika Check Hayden: So the Kuzu family, they originally came from Turkey and the father in the family, Mehmet Kuzu, is now a software engineer at Google. And they were living in Silicon Valley when their daughter Ipek was born. And soon after she was born, she was diagnosed with this disease called ataxia telangectasia, which is also called A-T disease. And when that happened, they set about trying to understand if there was anything they could do to treat the disease or slow the disease. And that's what led Mehmet down this path that eventually led him to work with Tim Yu.

Mehmet Kuzu: I sent the genetic report of our daughter. Then he said, oh, there's a potential here, but there are two main problems. He said this might cost around like two million, and the insurance will not cover it. The second problem, it might cause damage because, we have a theoretical idea, but biology is complicated. So at the end of the day, it might be worse than what is expected.

Wade Roush: Right. So for the Kuzu family, while it was obviously bad news that your kid is getting diagnosed with A-T disease, there is this amazing foundation or non-profit led by Brag Margus, the A-T Children's Project, that has all this data and also apparently has some fundraising clout. And they wind up helping to finance a lot of this research and even finance Ipeks treatment.

Erika Check Hayden: Right. And I think that's part of why this particular project was able to move so fast, because Brad Margus and the A-T Children's Project had done a lot of work over the years to fundraise and educate their community about the potential for treating this disease, so that when they found something that he actually thought could work, they were able to raise $1.4 million in a relatively short amount of time to fund the development of this unique drug.

Mehmet Kuzu: I think he understood to the promise of it. And then he agreed to financially support us. But the problem is this money in the pool is coming from many families. So we should have a fair selection. Then they found three kids that young in age, like three, two, two, three, four, with the right mutation type, and they got skin samples from all of them, and tested it. They were able to do it quickly.

Wade Roush: Mehmet can recount all these events pretty calmly. But I think its worth underscoring what a roller coaster the familys been on. The backing of the AT Childrens Project opened a window for Tim Yu to design and manufacture an antisense drug. But the required safety testing is so expensive that only there was only enough money to do that for one patient. There was a two in three chance that Ipek would not be that patient. And even if she did get selected, there was no way to know whether the treatment would be effective. Mila Makovec had been having fewer seizures since she started getting her antisense treatment, but doctors still werent 100 percent sure that it was because of the medicine. On top of all that, there was still the risk of unintended side effects.

Mehmet Kuzu: and then at the end of the day, Ipeks cells responded the best among these three candidates. Now, once we know we are selected, now we concentrate on second issue: do we really want to take this risk of, like, making things worse? And then I thought, like, most probably something good will happen. Of course there is a probability of, a possibility [of failure]. But imagine if that happens: science will learn from this. And her kind of sacrifice, and that would help, too, many other people.

Erika Check Hayden: It's been just incredible over the past few years to meet these families, understand what they're doing, how they're doing it. I've just been really struck by everything they've been able to accomplish. And also the mindset that they bring to this where, you know, you'll talk to, or I will talk to, parents who are doing this for their kids and they've had scientists tell them, 'You've got to be prepared for the possibility that this isn't going to help your kid. You know, you might be doing all of this work on behalf of some other future child. This might not come in time to help your own child.' And they persist and are really driven.

Wade Roush: Ok. So in the same way that Tim Yu helped to create this unique drug called milasen for Mila Makovec, he's created a drug called atipeksen for Ipek. If that drug if that drug works, how will it help Ipek?

Erika Check Hayden: If this drug works, basically what it's going to do is correct the way that Ipek's cells interpret her genetic information so that she will make a functioning copy of the ATM protein. Now, how we will know if this is working is a bit of a tricky question. So, Tim Yu and other doctors are going to try a variety of methods to see if they can tell whether the drug is actually helping her. So, for instance, they will look at things like can they see evidence in Ipek's body that the drug is actually making corrected versions of the protein? They will look for evidence that she isn't declining in the ways that we might expect her to if she wasn't getting treatment to help control her disease. But it might be tricky to tell whether it actually works or not.

Mehmet Kuzu: She had three injections until this point because they are starting with very low dose and escalating itAnd fortunately, we haven't seen any adverse effects in the first three. But like, of course, knowing if this is really working or not, they told us that it will take time. Maybe we need a year to understand if it's really working. But at least we have seen that no bad thing happened. At hospital she's going on the full anesthesia. They're putting on a mask. And after the injection they are taking bloods every four hours, three or four times. These are very stressful for her. She's fighting not to have this mask. She's crying a lot. Uh, but once discharge happens, once we come home, she forgets about everything. She just plays with her toys.

Wade Roush: Right. And this is one of the things you mentioned in your piece. Not only will it be tricky to see whether it's working or not, but we're talking about by definition an n of one study where there's only one patient. So you don't get the kinds of large numbers that help researchers feel more confident that a drug is safe and effective.

Erika Check Hayden: I think what we still don't know very well yet is which diseases are going to be helped most by this approach, or even if any of these individual customized treatments can cure a patient. So if you talk to Mila's mom, Julia Vitarello, she is very convinced that that drug has helped Mila. But I think accumulating that data to the level where we really know that this is a worthwhile approach, you know, that's probably going to take a while.

And to take a step back, I think that's part of the reason why these drugs are only being used right now in patients that have really severe progressive diseases, because you are taking a certain risk by giving a treatment to a patient when you haven't done the kinds of safety testing that we might be used to for a drug that would normally go through an FDA approval process. In fact, there are some people who object to even using the word treatment because we don't necessarily know that these drugs are going to cure the patients.

So in the meantime, I think everybody would like to see far more patients at least be able to try this. And so there's this question as to whether it's only going to be patients who have the resources to raise that money or access that money that are going to benefit. And I don't think anybody wants that to be the case.

Wade Roush: Are there any signs that the drug industry is looking at how to scale up some of these treatments? And, you know, maybe create a pipeline for hyper personalized drugs?

Erika Check Hayden: So we're seeing things like Ionis, their co-founder Stan Crooke has started a foundation called the n-Lorem Foundation that's going to try to develop these treatments for patients. The reason is that developing a drug for one patient that costs millions of dollars and doesn't really have a very large market is not something that's necessarily going to be attractive to a company. But I think people think there is a direction that could evolve where, you know, if the drug industry is better able to manufacture these drug templates or backbones and more easily switch out the part of the drug that's the business end that's doing the targeting of different genetic diseases to where that becomes much more large scale, much more customizable, much cheaper. You know, then you might see a model where this is much more economical, affordable, reimbursed by insurance companies, because right now this is not and obviously that's a major cost barrier.

Wade Roush: Do you think this is a time for patients with rare genetic disorders and families of those patients to feel more hopeful? Or is it just too early realistically for this to affect lots of people who are already suffering from these conditions?

Antonio Regalado: Right. It goes back to the question, should this be a breakthrough technology? Because right now, it's not helping that many people. We're talking about helping one person. Or we're talking about helping two or three very few people. Very few. And that's a strike against the idea, frankly. Like, why? Why should we invest resources into this when it helps so few people? Why should we call it a breakthrough technology? Well, the reason to is, it's sweet. Technically, it's sweet. And it paints a path towards a future where it like you can do a lot more with genetic drugs.

Wade Roush: So you can imagine a future not 100 years away, but maybe 10 years away, where this can be scaled up and broadened out to more patients.

Antonio Regalado: Yeah, absolutely. I mean, will the drugs work? How well will they work? It's kind of an open question. But yeah, we've already gone from one case to five cases next year no doubt it it'll be 10 and then a hundred and then thousands. Most likely. I want to raise something else, which this whole scenario is not fair. Because there's a lot of people with rare diseases and a lot of kids dying of rare disease in every neighborhood and every corner and every precinct of the country, of the world. So who has the opportunity to have this chance?

Wade Roush: Well, who does so far?

Antonio Regalado: Well, it is a very small subset of parents who for whatever reason have the ability to wrap their head around the science, to find where the opportunity is, and to raise quite a lot of money. And this is not bake sale money. This is two million dollars. Three million dollars. You have to really have a way to do that, and it favors people with a big network. That's why we're seeing people, you know, entrepreneurs from Silicon Valley or other people who just for whatever reason, manage to pull it off.

Wade Roush: If this kind of inequity persisted, it would definitely become a huge point of criticism around this whole area of therapy. But maybe you could look at these parents as the pioneers.

Antonio Regalado: Right. Exactly. A lot of the parents will say, well, in addition to trying to help my child, I also want to invest and try and create the process by which everybody else can be helped because they also have a lot of empathy for the next person. The idea is to help everybody. The pathway to doing that is not clear yet.

Wade Roush: All right. Well, whether this is a breakthrough or not, it raises so many interesting and thorny questions that it's perfect fodder for Technology Review.

Antonio: It's definitely a breakthrough, man. It's definitely a breakthrough.

Wade Roush: Okay. Thanks Antonio.

[Theme music]

Thats it for this edition of Deep Tech. This is a podcast were making exclusively for MIT Technology Review subscribers,to help bring alive some of the people and ideas youll find in the pages of our website and our print magazine. But the first four episodes cover our annual 10 breakthrough technologies issue, and were making those episodes free for everyone.

Deep Tech is written and produced by me and edited by Michael Reilly, with editorial help this week from Jennifer Strong. Our theme is by Titlecard Music and Sound in Boston. Special thanks this week to David Cameron, Howard Gelman, Erika Check Hayden, Mehmet Kuzu, Antonio Regalado, and Jane Wilkinson. Im Wade Roush. Thanks for listening, and we hope to see you back here for our next episode in two weeks.

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Podcast: A family on the frontier of hyper-personalized medicine - MIT Technology Review

March 11, 2020 -Henry Ford Health System has received a $25 million grant to accelerate its precision medicine program, with the ultimate goal of creating a Precision Health Center.

With the donation, Henry Ford will focus on advancing cancer research and treatment, as well as precision therapies for behavioral health, cardiovascular conditions, and metabolic diseases.

Henry Ford received the gift from developer Chris Jeffries and his wife Lisa. The donation is the largest single gift from an individual in the health systems 105-year history.

We are incredibly grateful to Lisa and Chris Jeffries for their generosity, saidWright Lassiter, III, president and CEO of Henry Ford Health System.

We are experiencing a momentous era in medicine, a radical shift from the traditional approach to cancer care. This gift will help us consolidate and advance our collective efforts to create unprecedented access to advanced, highly personalized treatments for our patients and members.

The grant will significantly boost the health systems translational research efforts, which quickly transforms the most innovative discoveries in the lab into new treatments for patients.

Translational research is a significant differentiator of our clinical programs at Henry Ford and is a critical element to help us treat many of the most challenging conditions our patients face, saidAdnan Munkarah, MD, executive vice president and chief clinical officer of Henry Ford Health System.

Translational research is bench-to-bedside, meaning it allows patients to benefit from discoveries in real time. That is an essential part of our history and commitment to medicine and academics not only offering the latest innovations in medicine, but also playing a leading role in their development.

The donation will build on the organizations past work to advance precision medicine and personalized care. In October 2017, Henry Ford Health System launched the Henry Ford Cancer Institute, a facility focused on ambulatory cancer treatment, precision medicine, clinical trials and research, and enhanced support services for cancer patients.

With the grant, researchers will be able to continue to develop individualized therapies for cancer and other conditions.

By analyzing genetic and non-genetic factors, we can gain a better understanding of how a disease forms, progresses and can be treated in a specific patient, saidTom Mikkelsen, MD, medical director of the Precision Medicine Program andClinical Trials Officeat Henry Ford Health System.

As of now, we can check for more than 500 genomic markers, which helps us understand the pattern of changes in a patients tumor cells that influence how cancer grows and spreads. Im confident this gift will lead to advancements that provide hope for patients with even the most complex diagnoses.

The Henry Ford Cancer Institute has one unified team of cancer specialists working to deliver personalized cancer treatments. The Institute includes five hospital locations, six additional outpatient cancer centers, and dozens of aligned doctors offices.

Even a decade ago, our approach to treating brain cancer was Precision Medicine before anyone knew what Precision Medicine was, said Steven Kalkanis, MD, CEO of Henry Ford Medical Group and Henry Fords chief academic officer.

In the time since, weve seen a significant increase in the number of brain cancer patients who are outliving their prognoses, due in large part to clinical innovation. Our relentless pursuit of clinical breakthroughs has more momentum now than at any other point in history.

The new grant will only serve to accelerate precision medicine in care delivery.

The support of our donors is the fuel behind our clinical innovations and the breakthroughs that are improving peoples lives, saidMary Jane Vogt, senior vice president and chief development officer at Henry Ford Health System. It is remarkable to work with donors who believe in a better tomorrow and the power of a unified approach to medicine.

The donation is expected to help drive innovations in treating brain, lung, pancreatic, and colon cancers, as well as other chronic diseases like cystic fibrosis, asthma, and heart disease.

The team at Henry Ford is second to none, said Chris Jeffries. We believe this gift will lead to other families having more time together. Defeating cancer requires a concerted effort from everyone and we hope to make as big an impact on that goal as possible.

Read the original:
Henry Ford Receives $25M Grant to Expand Precision Medicine Program - HealthITAnalytics.com

Dublin, March 11, 2020 (GLOBE NEWSWIRE) -- The "DNA Sequencing - Technologies, Markets & Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The value of DNA sequencer market in 2018 is described with estimates for 2023 and 2028. Various methods and factors on which market estimates depend are described briefly. Markets are tabulated according to geographical areas as well as applications. Small sequencers form the basis of SWOT (strengths, weaknesses, opportunities, threats) analysis. Several marketing strategies have been outlined. The report includes profiles of 147 companies involved in sequencing and their 173 collaborations.

The report briefly reviews basics of human genome variations, development of sequencing technologies, and their applications. Current large and small sequencers are described as well as companies developing them. Various applications of sequencing are described including those for genetics, medical diagnostics, drug discovery and cancer.

Next generation sequencing technologies, both second and third generations, are reviewed. Companies developing software for analysis of sequencing data are also included. Selected academic institutes conducting research in sequencing are also listed.

Current market is mostly for research applications and future markets will be other applications related to healthcare.

Key Topics Covered

Executive Summary 1. Introduction2. DNA Sequencing Technologies3. Role of Bioinformatics in Sequencing4. Comparative Analysis of Sequencing Technologies5. Sequencing for Research6. Applications of Sequencing in Healthcare7. Applications of Sequencing in Oncology8. Sequencing in Genetic Disorders9. Sequencing in Neurological and Psychiatric Disorders10. Applications of Sequencing in Infections11. Role of Sequencing in Personalized Medicine12. Current Status and Future Prospects13. Markets for Sequencers14. Companies Involved in Sequencing15. References

For more information about this report visit https://www.researchandmarkets.com/r/8bubjr

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Continued here:
DNA Sequencing Industry Insights and Outlook to 2028 - Analysis of Applications in Healthcare, Oncology and Infections - Benzinga

PALO ALTO, Calif., March 10, 2020 /PRNewswire/ -- Varian (NYSE: VAR) today announced Medisch Spectrum Twente Hospital in The Netherlands, and Icon Cancer Centre Wahroonga and Royal North Shore Hospital (RNSH) in Australia treated their first patients with Ethos therapy. Thisartificial intelligence (AI)-driven holistic adaptive therapy solution is designed to deliver an entire adapted treatment in a typical 15-minute timeslot.

Adaptive therapy provides the ability to personalize the patient's treatment based on their anatomy and position at the time of treatment. The goal is to better target the tumor, reduce dose to healthy tissue, and potentially improve overall outcomes.

At Medisch Spectrum Twente Hospital, the first two patients treated were for prostate cancer, at RNSH the first treatment was for head and neck cancer and at Icon Cancer Centre Wahroonga, the first treatment was for prostate cancer. Additionally, since delivering the first Ethos therapy in the world in September 2019, Herlev and Gentofte Hospitalin Denmark has already delivered 100 adaptive fractions for bladder cancer patients.

"Since the launch of Ethos therapy, the response from clinicians globally has been very strong," said Chris Toth, president Varian Oncology Systems. "Ethos therapy was designed to launch a new era of personalized adaptive radiation therapy and we are very pleased to see patients in Australia and The Netherlands now have access to these adaptive treatments. With Ethos therapy recently receiving 510(k) clearance, the first installation in the US is in process and will be treating patients soon."

Clinician Experience

"The future is adaptive," said Erik Van Dieren, head of Medical Physics, Medisch Spectrum Twente Hospital."With Ethos we know adaptive radiotherapy on a daily basis is achievable for a large number of patients due to high accuracy and excellent sparing of the healthy tissue in about 15 minutes treatment time."

"Early Ethos therapy experience from Icon is showing promising results," said Amy Teh, MD, radiation oncologist at Icon Cancer Centre, Wahroonga."In a prostate patient, where the target volume is highly dependent on bladder and rectal positioning, we have used the AI-driven online adaptive workflow on the Ethos platform to effectively and efficiently adapt to the new position of the bladder and rectum each day. This has allowed superior coverage of the true target. This technology marks another step forward in the advancement of radiation therapy taking personalized medicine to another level allowing us to ensure more dose to the tumor target, and less dose to surrounding healthy organs."

"RNSH is very pleased to enter the world of Ethos therapy after recently treating our first patient," said Jeremy Booth, head of Medical Physics, Northern Sydney Cancer Centre, RNSH. "The patient treatment for head and neck cancer was an exceptional experience, uniting our expert team of radiation therapists, medical physicists and radiation oncologists at the console to ensure we safely delivered the best treatment."

"We've found that, with bladder cancer patients, we are seeing the most impact using online adaptation," said Poul Geertsen, MD, PhD, head of Radiotherapy, Department of Oncology at Herlev and Gentofte Hospital. "With Ethos therapy, we are seeing treatment margin reductions of up to 50 percent, which is impressive."

The streamlined workflow of Ethos therapy is enabled by its AI-driven planning and contouring capabilities. Physicians define their clinical intent from pre-defined templates and the initial treatment plan is generated based on the physician's pre-defined clinical objectives. The treatment is adapted in response to changes in the patient's anatomy and the tumor's shape and position, at the time of treatment. The ability of Ethos to enable on-couch adaptive treatment puts the patient at the center of care.

Ethos therapy offers the use of multimodality images (MR, PET, CT) registered with daily iterative CBCT images at the console. By providing an up-to-date view of the patient's anatomy in multiple imaging modality views, Ethos therapy provides clinicians the confidence to make more informed adaptive treatment decisions. The solution is built on Varian's latest treatment delivery technology andprovides fast imaging and treatment delivery without compromising quality.

For more information on Ethos, visit http://www.varian.com/ethos.

About Varian

At Varian, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 10,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.comand follow @VarianMedSys on Twitter.

Customers were not paid for their testimonials. Individual results may vary

Press Contact

Mark PlungyDirector, Global Public Relations+1 (650) 424-5630 [emailprotected]

Investor Relations Contact

Anshul MaheshwariVice President, Investor Relations+1 (650) 424-5631 [emailprotected]

SOURCE Varian

https://www.varian.com/

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Ethos Therapy Continues Global Expansion - PRNewswire

(MENAFN - GlobeNewsWire - Nasdaq) Dublin, March 11, 2020 (GLOBE NEWSWIRE) -- The "Therapeutic Drug Monitoring (TDM) Technologies, Markets & Companies to 2028" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

This report deals with therapeutic drug monitoring, a multi-disciplinary clinical specialty, aimed at improving patient care by monitoring drug levels in the blood to individually adjust the dose of drugs for improving outcome. TDM is viewed as a component of personalized medicine that interacts with several other disciplines including pharmacokinetics and pharmacogenetics. One chapter is devoted to the monitoring of drugs of abuse (DoA). Various technologies used for well-known DoA are described. A section on drug abuse describes methods of detection of performance-enhancing drugs.

TDM market is analyzed from 2018 to 2028 according to technologies as well as geographical distribution. The global market for DoA testing was also analyzed from 2018 to 2028 and divided according to the area of application. Unmet needs and strategies for development of markets for TDM are discussed. The report contains profiles of 35 companies involved in developing tests and equipment for drug monitoring along with their collaborations. The text is supplemented with 21 tables, 9 figures and 210 selected references from the literature.

Benefits of the Report

The report contains information on the following:

Key Topics Covered Executive Summary

1. Introduction

2. Technologies for TDM

3. Drug Monitoring Instruments

4. Applications of TDM

5. Drugs Requiring Monitoring

6. Monitoring of Biological Therapies

7. Monitoring of Drug Abuse

8. Markets for TDM

9. Companies

10. References

For more information about this report visit https://www.researchandmarkets.com/r/pclxni

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

MENAFN1103202000703653ID1099832888

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Global Therapeutic Drug Monitoring Industry Insights, 2018-2028: Unmet Needs and Strategies for Development - MENAFN.COM

Current practices in drug development have led to therapeutic compounds being approved for widespread use in humans, only to be later withdrawn due to unanticipated toxicity. These occurrences are mostly the result of erroneous data generated by in vivo and in vitro preclinical models that do not accurately recapitulate human physiology.

To speed up new drugs to market and reduce animal testing, scientists from the Wake Forest Institute for Regenerative Medicine (WFIRM) have come up with a mindblowing solution. They have developed the worlds most sophisticated laboratory model of the human body, a system of miniaturized organs that can be used to detect harmful and adverse effects of drugs before they are prescribed to patients.

Scientists developed this system from many human cell types that are combined into human tissues representing a majority of the organs in the human body, such as the heart, liver, and lungs. Each of these miniature organs is tiny 3D tissue-like structures about one-millionth the size of an adult human organ.

Anthony Atala, MD, of the Wake Forest Institute for Regenerative Medicine and the studys senior author said,The most important capability of the human organ tissue system is the ability to determine whether or not a drug is toxic to humans very early in development and its potential use in personalized medicine. Weeding out problematic drugs early in the development or therapy process can save billions of dollars and potentially save lives.

During the experiment, this new model shows the potential of quantifying toxicity measure toxicity in many drugs approved for human use. Although toxicity from the recalled drugs was not found initially using standard 2D cell culture systems and animal testing models, and adverse effects were not detected throughout three levels of human clinical trials, this new system can readily detect toxicity, replicating the damage seen in humans.

To create the model, scientists isolated tiny samples of human tissue cells and engineered them into miniature versions of the human organ. These tissue cells can contain blood vessel cells, immune system cells, and even fibroblasts.

Each of these organs, also known as organ tissue equivalents, performs the same functions that they do in the human body. For example, the heart beats about 60 times each minute, the lung breaths the air from the surrounding environment, and the liver breaks down toxic compounds into harmless waste products.

Co-author Aleks Skardal, Ph.D., formerly of WFIRM and now at Ohio State University, said,We knew very early on that we needed to include all of the major cell types that were present in the original organ. To model the bodys different responses to toxic compounds, we needed to include all of the cell types that produce these responses.

Another exciting thing about the model that each system contains media, a substance containing nutrients and oxygen that is circulated among all the organ types, delivering oxygen, and removing waste. The small blood system n these devices use a technology called microfluidics to recirculate test compounds through the organ system and remove the drug breakdown products that each organ is producing.

Co-author Thomas Shupe, Ph.D., of WFIRM, said,Creating little human organs for drug testing was a logical extension of the work we have accomplished in building human-scale organs. Many of the same technologies we have developed at the human-scale level, like including a very natural environment for the cells to live in, also produced excellent results when brought down to the microscopic level.

Additional co-authors include Julio Aleman, Steven Forsythe, Shiny Rajan, Sean Murphy, Mahesh Devarasetty, Nima Pourhabibi Zarandi, Goodwell Nzou, Robert Wicks, Hooman Sadri-Ardekani, Colin Bishop, Shay Soker, and Adam Hall.

Authors Skardal, Shupe, Soker, Murphy, Bishop, and Atala are inventors on patent rights related to this work owned by Wake Forest University Health Sciences. The patents, whose value may be affected by publication, have the potential to generate royalty income in which the inventors would share.

The study is published in the journal Biofabrication.

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Scientists developed the worlds most sophisticated lab model of the human body - Tech Explorist

Medicare now recognizes the important work that primary care physicians do when it comes to preventive screenings in older patients. So instead of only paying doctors for sick visits, the program will pay physicians to perform a preventive annual Medicare wellness visit (AWV).

But physicians should make some adjustments to their practices to ensure they adapt to what is the first of several Medicare changes intended to promote preventive care and improve care coordination and chronic disease management for Medicare patients.

The AMA STEPS Forward module Medicare Annual Wellness Visit (AWV): Streamline Workflow to Perform a Thorough AWV helps physicians understand the AWV, communicate with patients to set expectations about the visit and map out an AWV workflow.

TheAMAsSTEPS Forward open-access modules offerinnovative strategies that allow physicians and their staff to thrive in the new health care environment. These courses can help you prevent physician burnout, create the organizational foundation for joy in medicine and improvepractice efficiency.

The AWV is a primary care visit that involves preventive care, advanced care planning and depression and dementia screening. It gives physicians a chance to focus on safety issues, such as falls, and social needs, such as food insecurity and transportation. Physicians and their teams can update information in a patients chart, such as a medication list, or they can create and maintain a personalized screening and prevention plan.

The Centers for Medicare and Medicaid Services (CMS) is recognizing that these visits help enhance a patients quality of life and that they are different from traditional sick visits. Identifying mental health concerns, cognitive impairments and other factors often involves in-depth conversations and non-face-to-face work. And physician offices can set up a system where all members of the care team contribute to the effort, maximizing patient benefit, practice pay and time savings.

Here are three steps to optimize annual wellness visits in your practice.

An annual wellness visit is different from the initial preventive physical examination, known as the IPPE. AWVs are offered to patients 12 months after they enroll in Medicare Part B and they are then covered once every 12 months.

Numerous components are part of the initial AWV, including screening for cognitive impairment and reviewing functional ability and level of safety. Nonphysician members of the care team can perform most of the components; the physicians role is to synthesize the findings and provide recommendations. During subsequent visits, the information is reviewed and updated.

Make clear this visit is not the same as an annual physical and doesnt include a physical exam. Medicare covers the AWV 100%, but any evaluation and management (E/M) work done during the visit is subject to copays, deductibles and coinsurance.

An AWV is covered only once every 12 months, so if a patient has had one elsewhere in that timeframe, they are not eligible for another one from your office.

First, physician offices will need to decide whether to combine AWV and problem-based visits. The STEPS Forward module then offers a sample process map as guidance on how to map out each step of the visit.

For example, if an office chooses to combine an AWV with E&M, the module outlines how to conduct and document the visit using both AWV and E&M templates.

TheCMEmodule, Medicare Annual Wellness Visit (AWV) Streamline Workflow to Perform a Thorough AWV,is enduringmaterial and designated by the AMA for a maximum of0.5AMA PRA Category 1 Credit.

The module is part of theAMA EdHub,anonline platformwith top-quality CME and education that supports the professional development needs of physicians and other health professionals. With topics relevant to you, it also offers an easy, streamlined way to find, take, track and report educational activities.

Learn more aboutAMA CME accreditation.

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3 steps to add annual Medicare wellness visits in your practice - American Medical Association

Institutes participating in the partnership include the Stanford University School of Medicine, the Fred Hutchinson Cancer Research Center, and Parker Institute for Cancer Immunotherapy.

The Cocoon platform is a closed automated cell therapy manufacturing platform enabling decentralized process development. A transportable cassette that internalizes all of the media, agents, and consumables used in the process is attached inside and the Cocoon closes and begins processing.

Each Cocoon develops therapy for one patient, therefore the technology is patient-scale, and the process can be scaled with many Cocoons, attached on Cocoon trees operating at the same time.

Under the agreement, Lonzas experts will work collaboratively with research teams of the partners to transfer some of their existing cell-based immunotherapies, which are in pre-clinical phase, to the Cocoon bioprocessing system.

Subsequently, the process development will be shared between the partners facilities and Lonzas R&D site in Shady Grove (MD), US.

Once these therapies enter the clinic, whether manufacturing is at the institutes or elsewhere, the Cocoon platform will enable this, Eytan Abraham, head of personalized medicine at Lonza, told us.

Asked about the potential immunotherapies examined, Abraham said that they target a combination of hematological malignancies, solid malignancies, and processes that use non-viral delivery of the gene of interest.

Use of the Cocoon technology can potentially benefit the organizations development projects in several ways, including increased process control, reductions in costs, manpower, time and space requirements, as well as offering superior scalability thereby enabling treatment of larger patient populations.

Further than that, Lonza expects the partnerships to help assess the technology and evaluate the platforms potential to manufacture a range of cell therapies comparable to those manufactured through other processes currently available.

Through these collaborations we are both showcasing the Cocoon advantages and capabilities, but also learning what is needed for decentralized based manufacturing of the next wave of patient scale cell therapies, Abraham told us.

He added that, accordingly, the company will continue to evolve the system to answer these needs, whether they increase cell numbers, improve in-process analytics, integration of additional technologies, such as magnetic cell separation and electroporation, or scaling technologies.

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Lonza partners with three institutes on Cocoon system - BioPharma-Reporter.com

The field of genomics has made fantastic progress in the fields of biomedical research and clinical development. This is good news for patients and excellent news for investors, as the field of genomics is expected to pay large dividends in finance in the coming decade.

Despite being a relatively new field in the space of biology research, genomics has made massive advances in science and medicine in the past few years. Research into the human genome has led to the development of personalized medicine, changing the clinical landscape for cancer treatment and rare genetic diseases, in particular. The cost associated with mapping one genome has dramatically dropped in a very short space of time, costing millions of dollars and years of effort at the start to now costing in the hundreds of dollars per sequence that is delivered in a matter of days. This has allowed worldwide entry into this space, and an explosion of new discoveries and advances.

The global genomics market size is expected to reach USD 31.1 billion by 2027, registering a CAGR of 7.7% over the forecast period, according to a new report by Grand View Research, Inc. Significant changes in disease management processes along with advancements in genomics and personalized medicine are expected to propel the market.

Grand View Research is a U.S.-based market research and consulting company, providing syndicated as well as customized research reports and consulting services. Headquartered in San Francisco, the companys analysts and consultants report in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment.

The report that was recently published makes several suggestions as to what is anticipated to be leading this growth. The consumables and reagents deliverable segment is expected to register the highest growth rate, owing to high costs and volume associated with reagents needed for sequencing. This field is filled by companies that service actual research companies, and oftentimes are the main operating costs of lab testing.

The computational services deliverable segment is also set to expand at a considerable CAGR from 20202027 owing to the increasing demand for computational sequence alignment and analysis among molecular biologists. Interpreting sequencing data is a somewhat complicated process, and software and people capable of interpreting the results are at an ever-increasing demand in this space.

In terms of investment into future research and development for predictive biomarkers targeted toward diagnosis and patient monitoring, substantial investments by biotechnology and pharmaceutical companies have contributed significantly to the revenue generated by the biomarker discovery application segment. Clinical trials using genomics sequencing have oftentimes been wildly successful, driving more and more disease-based research to consider its use for new treatment strategies, as well as a search for biomarkers at a breakneck speed.

The success of use of genomic sequencing is a worldwide affair, and the Asian Pacific region is a potentially lucrative market for genomics, and is anticipated to expand at the highest CAGR of 9.1%. Regionally, genomics is being used everywhere, particularly in North America and Europe, but also in Asia, South America, the Middle East, and Africa.

Key companies in the genomics market tend to be located in the United States or Europe, and the largest players include 23andMe; F. Hoffmann-La Roche Ltd.; BGI; Myriad Genetics Inc.; Danaher.; Pacific Biosciences; Illumina; Agilent Technologies; Thermo Fisher Scientific, Inc.; Foundation Medicine; Oxford Nanopore Technologies; and Bio-Rad Laboratories.

Of these companies, an increasing pool of market innovators mostly from 23andMe, Oxford Nanopore Technologies, and Veritas Genetics (each having launched breakthrough genomic technologies in recent years) are also contributing toward market development. 23andMe in particular has expertise in developing direct-to-consumer genomic tests targeted toward disease prognosis and has received FDA approval for its commercialization.

MinION, a sequencing device from Oxford Nanopore Technologies, is witnessing significant traction owing to its ability to sequence any fragment length of DNA in real time. In the same field, Veritas Genetics is offering an affordable solution for a complete readout of a genomic sequence. A few years ago, it was only possible to procure this information if ordered by a doctor, but now these tests can be taken by anyone curious about their DNA and costs approximately USD 1,000. Veritas Genetics has also begun the commercialization of this technique for newborns genomic sequencing applications in China.

Genomic sequencing and biomarker identification is hardly the only source of income in the field of genomics. Other deliverables besides products and services include functional genomics in basic laboratory research and aspects of costs associated; the study of epigenetics and computer data analysis associated with large data sets; and genomics end-use, in clinical and research laboratories, academic and government institutes, hospitals and clinics, and of course pharmaceutical and biotechnology companies.

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Genomics Research Market Worth to Exceed $31 Billion by 2027 - Clinical OMICs News

Collaboration to focus on improving outcomes, increasing patient satisfaction and reducing costs

CHICAGO, March 5, 2020 /PRNewswire/ -- ImmersiveTouch has announced a collaboration with HP that strives to unleash the power of personalized medicine by providing the missing link between medical imaging and real-time surgery. This collaboration will pair ImmersiveTouch clinical software with HP hardware to create better healthcare outcomes at reduced costs. The companies will jointly showcase their technologies at the annual HIMSS conference in Booth 1541 from March 10th-12th.

ImmersiveTouch is revolutionizing personalized care by designing technology that more accurately simulates each patient's specific anatomy in 360 VR. Surgeons can feed traditional CT and MRI scans into ImmersiveTouch software, strap on virtual reality headsets, and then virtually fly through simulations of muscles, bones and blood vessels, exploring the specific dimensions of the disease they must attack from every angle. ImmersiveTouch continually strives towards increased patient satisfaction and improved surgical planning, and away from longer procedure times, sub-optimal patient outcomes and readmissions.

From radiology to surgery, the companies plan to combine their clinical software and hardware expertise to market products and solutions that can be customized to the needs of an individual patient. In the near-term, the collaboration will focus on promoting ImmersiveTouch software powered by HP's Reverb Pro VR headsets and connected to HP Jet Fusion 3D printers.

"ImmersiveTouch and HP together will shift the paradigm for high quality virtual reality experiences in healthcare," said Jay Banerjee, COO of ImmersiveTouch. "We are immersing surgeons to train and rehearse for mission-critical situations. The industry is poised to enter a new era of personalized care."

ImmersiveTouch has been installed in over 100 hospitals globally and is proud to facilitate personalized care through its technological innovation.

Recently at MetroHealth Hospital in Cleveland, a neurosurgeon was able to confirm his suspicion from the initial radiological report after reviewing the case with ImmersiveTouch. After the immersive planning session, the surgeon altered his surgical approach and was more accurately prepared.

In the spirit of the HIMSSmission to "realize the full health potential of every human, everywhere", ImmersiveTouch will invite one of its pioneer enterprise customers, Dr. Shafiq Rab, CIO of Rush Hospital, to speak on the HIMSS panel session titled "3D Print & VR: Improving Surgical Outcomes & Informed Consent".

About ImmersiveTouch Inc.

ImmersiveTouch strives to strengthen human life and unleash the power of personalized care by providing the missing link between medical imaging and real-time surgery. ImmersiveTouch is using the latest advancements in computer vision,artificial intelligenceand AR/VR to develop FDA cleared medical technology. The company provides a fullsoftware suite for surgical planning, surgery skills training, and informed patient consent. http://www.immersivetouch.com

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ImmersiveTouch Partners with HP on Virtual Reality and 3D Printing for Personalized Health Care Solutions - Yahoo Finance

Dublin, March 10, 2020 (GLOBE NEWSWIRE) -- The "Biomarkers Market Size, Share & Trends Analysis Report by Type (Safety, Efficacy, Validation), by Application (Diagnostic, Drug Development, Personalized Medicine), by Disease, and Segment Forecasts, 2020-2027" report has been added to ResearchAndMarkets.com's offering.

The global biomarkers market size is expected to reach over USD 129.4 billion by 2027. It is anticipated to exhibiting a CAGR of 13.7%, during the forecast period. Factors, such as increasing collaborations and funds for R&D activities, rising consumer awareness, a widening patient base, and technological advancements collectively augmenting market growth.

The drug discovery segment contributed the highest revenue in 2019. Pharmaceutical companies focus on extensive R&D initiatives for the development of targeted therapeutics. Coordinated strategic efforts on biomarker development remain a searing trend among drug manufacturers, academic research institutions, commercial R&D organizations, non-profitable health foundations, and federal government biomedical regulatory and research agencies.

North America continued to lead the biomarkers market in 2019, driven by an amplifying demand for personalized medicines, high disease prevalence, and proactive government initiatives. It is expected to maintain its lead over the forecast period. Asia Pacific is positioned to witness the fastest CAGR, over the forecast period, spearheaded by India.

Some key market players include Abbott, Roche, Qiagen, Siemens Healthcare, Thermo Fisher Scientific, Bio-Rad Laboratories, Johnson & Johnson Services, Agilent Technologies, and Epigenomics. The players are developing novel kits and therapies and drugs to target population in the areas with high unmet clinical needs.

Further key findings from the study suggest:

Key Topics Covered

Chapter 1 Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Biomarkers Market Variables, Trends & Scope3.1. Biomarkers Market Lineage Outlook3.1.1. Clinical Diagnostics Market Outlook3.2. Penetration & Growth Prospect Mapping3.3. Regulatory Framework3.3.1. Reimbursement Framework3.3.2. Standards & Compliances3.4. Market Dynamics3.4.1. Market Driver Analysis3.4.1.1. Increasing Prevalence of Chronic Diseases3.4.1.2. Technological Advancements3.4.1.3. Funding for Biomarkers3.4.2. Market Restraint Analysis3.4.2.1. Reimbursement Policies3.5. Biomarkers Market Analysis Tools3.5.1. Industry Analysis - Porter's3.5.2. PESTEL Analysis3.5.3. Major Deals & Strategic Alliances Analysis

Chapter 4. Biomarkers Market - Competitive Analysis4.1. Recent Developments & Impact Analysis, by Key Market Participants4.2. Company/Competition Categorization (Key Innovators, Market Leaders, Emerging Players)4.3. Vendor Landscape4.3.1. List of Key Distributors and Channel Partners4.3.2. Key Company Market Share Analysis, 20194.4. Public Companies4.4.1. Company Market Position Analysis (Revenue, Geographic Presence, Product Portfolio, Key Serviceable Industries, Key Alliances)4.4.2. Company Market Share4.4.3. Competitive Dashboard Analysis4.4.4. Market Differentiators4.4.5. Synergy Analysis: Major Deals & Strategic Alliances4.5. Private Companies4.5.1. List of Key Emerging Companies4.5.2. Regional Network Map4.5.3. Company Market Position Analysis (Geographic Presence, Product Portfolio, Key Alliance, Industry Experience)

Chapter 5. Biomarkers Market: Type Estimates & Trend Analysis5.1. Definitions & Scope5.2. Type Market Share Analysis, 2019 & 20275.3. Biomarkers Market, by Type, 2015 to 20275.4. Market Size & Forecasts and Trend Analyses, 2015 to 2027 for the following:5.4.1. Safety5.4.2. Efficacy5.4.3. Validation

Chapter 6. Biomarkers Market: Application Estimates & Trend Analysis6.1. Definitions & Scope6.2. Application Market Share Analysis, 2019 & 20276.3. Biomarkers Market, by Application, 2015 to 20276.4. Market Size & Forecasts and Trend Analyses, 2015 to 2027 for the following:6.4.1. Diagnostics6.4.2. Drug Development6.4.3. Personalized Medicine

Chapter 7. Biomarkers Market: Disease Estimates & Trend Analysis7.1. Definitions & Scope7.2. Disease Market Share Analysis, 2019 & 20277.3. Biomarkers Market, by Disease, 2015 to 20277.4. Market Size & Forecasts and Trend Analyses, 2015 to 2027 for the following:7.4.1. Cancer7.4.2. Cardiovascular Disease7.4.3. Neurological Disease7.4.4. Immunological Disease7.4.5. Others7.5. Disease Market, by Type, 2015-2027:7.5.1. Cancer7.5.2. Cardiovascular Diseases7.5.3. Neurological Disease7.5.4. Imunological Disease7.5.5. Others

Chapter 8 Biomarkers Market: Regional Estimates & Trend Analysis8.1 Biomarkers Market: Regional Movement Analysis, 2019 & 20278.2 Biomarkers Market: Leading Players, 20198.3 SWOT Analysis, by Factor (Political & Legal, Economic and Technological)8.4 North America8.5 Europe8.6 Asia-Pacific8.7 Latin America8.8 MEA

Chapter 9 Competitive Landscape9.1 Strategy Framework9.2 Heat Map Analysis of Private Companies9.3 F-Hoffman La Roche Ltd.9.4 Abbott9.5 Epigenomics AG9.6 General Electric Company9.7 Johnson & Johnson9.8 Thermo Fisher Scientific Inc.9.9 Bio-Rad Laboratories Inc.9.10 Siemens Healthcare Private Limited9.11 Qiagen

For more information about this report visit https://www.researchandmarkets.com/r/1r1wle

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Biomarkers Market Outlook, 2020-2027 - Featuring Profiles of Key Players Abbott, Roche, Qiagen, Siemens Healthcare, Thermo Fisher Scientific,...

OAKLAND, Calif.and SAN DIEGO, March 9, 2020 /PRNewswire/ --Blue Shield of California has become the first health plan in the United States to cover rapid and ultra-rapid Whole Genome Sequencing to help critically ill babies and children in intensive care with unexplained medical conditions receive precision care.

Rady Children's Institute for Genomic Medicine researchers have pioneered the fastest use of this advanced diagnostic technology to rapidly identify and decode the root causes of rare genetic disorders for some of the sickest infants and children hospitalized in intensive care across the country.

The Rady Children's Institute team offers the quickest turnaround of genomic test results available nationwide, delivering a preliminary diagnosis in less than three days for medically urgent cases. The blood samples can be taken at any hospital and sent to Rady Children's Institute for sequencing and analysis.

"Our system is optimized to identify or rule out most genetic diseases in a single test, and provide the medical team at the bedside with child-specific, disease-specific information so they can make better, faster medical decisions," said Stephen Kingsmore, M.D., DSc, president and CEO of the Institute.

Whole genome sequencing scans a child's entire genetic makeup for thousands of anomalies from a blood sample. Rady Children's specialists also provide consultation to the medical team caring for the patient to offer targeted guidance that can enable timely and precise personalized care.

"We know that uncertainty and long testing wait times can create tremendous risks for children in intensive care, and anxiety for their families, all the while creating more challenges for physicians and specialists," said Terry Gilliland, M.D., executive vice president of Healthcare Quality and Affordability at Blue Shield of California. "By providing our members with access to Rady Children's Institute for Genomic Medicine's pioneering work in rapid whole genome sequencing, we're supporting them in what is often the most difficult time in their lives."

Blue Shield members with Individual and Family Plans or employer-sponsored health plans who have a critically ill child, up to age 18, hospitalized in neonatal or pediatric intensive care at any location with an undiagnosed condition may be eligible.

This is the latest example of Blue Shield's leadership in making the newest evidence-based medical technologies and services available to its members.

The nonprofit health plan also was the first insurer to cover confirmatory testing for members who received a positive Ashkenazi Jewish BRCA finding from consumer genetic-testing companies such as 23andMe, as well as prostate gene expression assays for patients with low risk prostate cancer, helping them to avoid unnecessary radiation treatment and surgical intervention.

Without medical insurance coverage, access to rapid Whole Genome Sequencing is often not readily available for many hospitalized children who could potentially benefit from this service. Families in need of this care have often had to rely upon funding provided by private philanthropy and research grants to gain access to rapid Whole Genome Sequencing and associated precision care.

"Genetic disease is a leading cause of infant death in the U.S. and Blue Shield is paving the way in providing coverage for this rapid, molecular diagnosis that can result in life-saving treatments," Dr. Kingsmore said.

Located on the campus of Rady Children's Hospital-San Diego, the Institute houses a state-of-the-art genome sequencing lab and employs a multi-disciplinary team of experts who specialize in providing timely and accurate guidance to physicians caring for children with rare genetic disease.

About Blue Shield of CaliforniaBlue Shield of California strives to create a healthcare system worthy of our family and friends that is sustainably affordable. Blue Shield of California is a tax paying, nonprofit, independent member of the Blue Cross Blue Shield Association with over 4 million members, 6,800 employees and more than $20 billion in annual revenue. Founded in 1939 in San Francisco and now headquartered in Oakland, Blue Shield of California and its affiliates providehealth, dental, vision, Medicaid and Medicare healthcare service plans in California. The company has contributed more than $500 million to Blue Shield of California Foundation since 2002 to have an impact on California communities.

For more news about Blue Shield of California, please visitnews.blueshieldca.com. Or follow us on LinkedIn, Twitter, or Facebook.

About Rady Children's Institute for Genomic MedicineThe Institute is leading the way in advancing precision healthcare for infants and children through genomic and systems medicine research. Discoveries at the Institute are enabling rapid diagnosis and targeted treatment of critically ill newborns and pediatric patients at Rady Children's Hospital-San Diego and partner hospitals. The vision is to expand delivery of this life-saving technology to enable the practice of precision pediatric medicine at children's hospitals across California, the nation and the world. RCIGM is a subsidiary of Rady Children's Hospital and Health Center. Learn more at http://www.RadyGenomics.org. Follow us on Twitterand LinkedIn.

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Blue Shield of California Becomes First Health Plan in U.S. to Cover Cost of Rapid Whole Genome Sequencing for Critically Ill Children - P&T Community

New York, March 09, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cloud Computing in Cell Biology, Genomics and Drug Development" - https://www.reportlinker.com/p05873501/?utm_source=GNW The report analyzes trends and dynamics including drivers, limitations, challenges and opportunities.

The report discusses strategies adopted by emerging market players with recommendations for new market entrants.This research study discusses historical, current and potential market size.

The report will help market players and new entrants to make informed decisions about the production and export of goods and services, as well as providing organizations, distributors and exporters information about market development and trends.The study segments the market on the basis of applications and end uses.

A geographical market analysis is provided for all major segments.

Report Includes: - 43 data tables and 18 additional tables - An overview of the global market for cloud computing applications in cell biology, genomics and drug development - Analyses of global and regional market trends, with data from 2018 to 2019, and projections of compound annual growth rates (CAGRs) through 2024 - Assessment of market trends and opportunities, key developments and the impact of cloud computing technology on the biotechnology, pharmaceutical and healthcare industry verticals - Insight into recent developments in cloud infrastructure and information pertaining to key partnerships between cloud service providers and pharma/biotech companies and investment in pharmaceutical R&D sector - Discussion of the suppliers' landscape, as well as the market positioning and strategies of key manufacturers and suppliers for cloud computing applications - Review of patent applications filed regarding cloud computing technology in the U.S. healthcare sector - Company profiles of the leading market players, including Amazon Web Services (AWS) Inc., Cisco Systems Inc., DXC Technology, Google LLC, Salesforce.com Inc., and SAP SE

Summary The global market for cloud computing in cell biology, genomics and drug development is estimated to grow at a CAGR of REDACTED during the forecast period.The market was valued at REDACTED in 2018 and is expected to reach REDACTED in 2024.

In biomedical research, cloud computing has resolved big data concerns and improves data, analytics, collaboration and sharing. Increasing biomedical research based on human, animal, plants, and microbes has increased the dependency on proper storage and network infrastructure as well as secure and scalable computing.

With growing big data concerns, researchers are inclined towards cloud computing platforms.These platforms provide flexibility to users to pay according to their usage of cloud services including software, hardware infrastructure and platforms to solve biomedical computation concerns.

The cloud offers ondemand storage and an analysis facility to users which makes it an emerging computing platform to address big data concerns.Owing to the flexibility and cost-effectiveness, cloud services are gaining significant importance in life science research for data storage, communication and collaboration with stakeholders.

On cloud platforms, large datasets and applications for gene sequencing, image analysis, protein folding and data mining can be shared for collaborative research between facilities.

The major pivotal factors contributing to the growth of the market include rising genomics and proteomics research and the increasing number of clinical trials performed across various countries.Considerable public and private investment in genomics and proteomics research is providing support to biotechnology start-ups and research institutes.

This helps healthcare providers to develop and commercialize genomics technologies and personalized medicines. Increasing U.S. FDA approvals for personalized medicines are supporting the growth in genomics research. For example, according to the Personalized Medicine Coalition, in 2018, approximately REDACTED of the REDACTED new molecular entities (NMEs) approved by the FDA are personalized medicines which constitute REDACTED of all new drug approvals. The Coalition classified REDACTED of NMEs as personalized medicines in 2017, REDACTED in 2015 and REDACTED in 2016. The U.S. FDA is making efforts to facilitate access to genomic testing and integration of real-world evidence into its regulatory framework. As a result, the FDA has begun to authorize the marketing of cancer-related genetic tests, and pharmacogenetics were allowed to be sold directly to the consumers. This has resulted in the development of personalized medicine as an emerging practice of medicine that utilizes the genetic profile of an individual to make appropriate decisions regarding prevention, diagnosis and treatment of the condition. Gaining complete knowledge about the patient's genetic profile helps doctors to choose proper therapy or medication and to administer it with the proper regimen or dose. Significant data is generated by sequencing a single human genome which necessitates the adoption of cloud services. The 1000 Genomes Project is an effort to sequence genomes of at least a thousand people from across the globe to develop the most comprehensive and medically relevant picture of human genetic variation. This initiative intends to make genomic data easily accessible from international research institutions. Major support for the project is offered by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH), Wellcome Trust Sanger Institute in Hinxton, England and the Beijing Genomics Institute, Shenzhen (BGI Shenzhen) in China.Read the full report: https://www.reportlinker.com/p05873501/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Cloud Computing in Cell Biology, Genomics and Drug Development - Benzinga

BOSTON--(BUSINESS WIRE)--Invicro LLC, a Konica Minolta Company announced it has entered into a strategic research partnership with industry leading pathologist, Dr. David Rimm, MD, PhD, at The Yale University School of Medicine to advance the development of Quanticell, Konica Minoltas proprietary tissue biomarker detection technology.

Invicro is a global provider of imaging biomarkers, core lab services, CAP-CLIA pathology services, advanced analytics and software solutions for drug discovery and development. Dr. Rimm is the Professor of Pathology and Medicine; Director of Pathology Tissue Services; and Director of Translational Pathology at Yale University.

Quanticell is an ultra-sensitive, quantitative, amplification-free technology that detects proteins at the cellular and subcellular level using photostable, highly bright phosphor-integrated dots (PIDs). This nanoparticle-based detection technology circumvents the limitations observed with traditional multiplex chromogenic and fluorescent-based assays, such as signal saturation, non-linearity and high background.

With his unmatched knowledge and experience in anatomical pathology, product commercialization, and late-stage clinical trials, Dr. Rimm is a leading pioneer in the quantitative pathology space, said Dr. Ken Bloom, Chief Medical Officer for Advance Pathology Solutions for Invicro. We could not be happier to have him as a scientific research partner. I am highly confident that his efforts will support the advancement of Quanticell for specific drug development initiatives.

Chromogenic-based Immunohistochemistry (IHC) is ubiquitously used in research and clinical practice, including companion diagnostics (CDx). Despite IHCs wide use, underperforming assays often require additional molecular testing due to narrow detection range. With expertise in quantitative and digital pathology and having invented the AQUA technology for predicting response to therapies or recurrence in a myriad of disease indications, Dr. Rimm and his research team will evaluate a multitude of assay conditions to assess Quanticells technology performance for quantifying HER-2 expression across a much wider dynamic range.

I am thrilled to be working on this cutting-edge technology that has the potential to revolutionize molecular drug target testing that will in turn maximize therapeutic efficacy and reduce undesired toxicity, said Dr. Rimm. In previous studies performed in my laboratory, we have found that HER-2 protein expression spanned three logs of dynamic range and discovered DAB-based methods typically only show a linear range of one log, which we hypothesize can be addressed with Konica Minoltas novel detection technology.

About Invicro

Headquartered in Boston, MA, Invicro was founded in 2008 with offices, laboratories and clinics around the world, from coast-to-coast within the United States, to Europe and Asia that support leading pharmaceutical and biotechnology and top research universities. Invicros multi-disciplinary team provides solutions to help enhance the discovery and development of life-changing drugs across all stages of the drug development pipeline (Phase 0-IV), leveraging all modalities within a broad scope of therapeutic areas, including neurology, oncology, cardiology, and immunology. Invicros quantitative biomarker services, advanced analytics tools, and clinical operational services are backed by their industry-leading software informatics platforms, VivoQuant and iPACS.

Invicro is a Konica Minolta company and part of their precision medicine initiative, which aims to accelerate personalized medicine, discover novel therapeutic targets and develop innovative therapeutic technologies for unmet medical needs. Along with their sister company, Ambry Genetics, Invicro develops and leverages the latest approaches in quantitative biomarkers including imaging, quantitative pathology and genomics. Visit http://www.invicro.com for more information.

About Konica Minolta

Konica Minolta, Inc. (Konica Minolta) is a global digital technology company with core strengths in imaging and data analysis, optics, materials, and nanofabrication. Through innovation, Konica Minolta creates products and digital solutions for the betterment of business and societytoday and for generations to come. Across its Business Technologies, Healthcare, and Industrial-facing businesses, the company aspires to be an Integral Value Provider that applies the full range of its expertise to offer comprehensive solutions to the customers most pressing problems, works with the partners to ensure the solutions are sustainable, anticipates and addresses tomorrows issues, and tailors each solution to meet the unique and specific needs of its valued customers. Leveraging these capabilities, Konica Minolta contributes to productivity improvement and workflow change for its customers and provides leading-edge service solutions in the IoT era. Headquartered in Tokyo and with operations in more than 50 countries, Konica Minolta has more than 43,000 employees serving approximately two million customers in over 150 countries. Konica Minolta is listed on the Tokyo Stock Exchange, (TSE4902). For further information, visit: https://www.konicaminolta.com/

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Invicro Collaborates with Yale's Dr. David Rimm to Expand the Utility of Quanticell for Clinical Pathology Applications - Business Wire

(CNN) Whether youre inclined to choose coffee or green tea for your morning boost could be determined by your genes, a recent study found.

To examine genetic associations with food preferences, researchers from the Riken Center for Integrative Medical Sciences (IMS) and Osaka University in Japan studied the genetic data and food preferences of more than 160,000 people in Japan.

The research, published in the journal Nature Human Behavior, found genetic links for 13 dietary habits including consumption of alcohol, other beverages and foods, and also complex human diseases such as cancer and diabetes.

We know that what we eat defines what we are, but we found that what we are also defines what we eat, said Yukinori Okada, Senior Visiting Scientist at Riken IMS and professor at Osaka University, in a press release.

Genome studies are typically conducted to associate specific genetic variations with particular diseases, according to the National Human Genome Research Institute, part of the US National Institutes of Health.

This involves grouping thousands of people together depending on whether they have a disease and looking at DNA markers called single nucleotide polymorphisms, or SNPs, which can be used to predict the presence of that disease. If researchers find a SNP that is repeatedly associated with the disease group, they can assume that people with that genetic variation might be at risk for the disease.

Rather than looking at diseases, the Riken team examined dietary habits to find out if there were any markers that made people at risk for typically eating certain foods.

The researchers used data of more than 160,000 Japanese people from the BioBank Japan Project, launched in 2003 with a goal to provide evidence for the implementation of personalized medicine. The project collects DNA and clinical information, including items related to participants lifestyles such as dietary habits, which were recorded through interviews and questionnaires.

They found nine genetic locations that were associated with consuming coffee, tea, alcohol, yogurt, cheese, natto (fermented soybeans), tofu, fish, vegetables and meat.

Variants responsible for the ability to taste bitter flavors were also observed. This association was found among people who liked to eat tofu; while those without the variant consumed less alcohol or none at all.

Those who ate more fish, natto, tofu and vegetables had a genetic variant that made them more sensitive to umami tastes, best described as savory or meaty flavors.

The main ingredients of the foods mattered, too for example, there were positive genetic correlations between eating yogurt and eating cheese, both milk-based foods.

In order to find whether any of these genetic markers associated with food were also linked with disease, the researchers conducted a phenome study.

The phenome comprises all the possible observable traits of DNA, known as phenotypes. Six of the genetic markers associated with food were also related to at least one disease phenotype, including several types of cancer as well as type 2 diabetes.

Since the research studied only people native to Japan, the same genetic variations associated with food preferences are likely not applicable to populations across the globe. However, similar links have been discovered in different groups.

A 2014 study presented at the European Journal of Human Genetics meeting in Milan identified a genetic variant that affects preferences for butter or oil on bread. A separate European study from the same year found genetic variants related to the perception of saltiness of a food.

A form of a bitter receptor gene was found, in a 2014 study, to contribute to differences in the enjoyment of coffee: People who perceived stronger bitterness liked coffee more; those with a lower bitterness perception liked coffee less.

The study authored by Okada also didnt measure environmental factors. Our environment, demographics, socioeconomic status and culture such as whether we eat food from work or home; our age; how much money we make; and what our families eat are some of the biggest drivers of our food choices.

These factors would weigh more than the genetics in some cases, said Dr. Jos Ordovs, director of Nutrition and Genomics at Tufts University in Massachusetts, who was not involved in the study.

Given all the findings that genetic differences influence not only responses to foods but preferences as well, experts think considering them can help nutritionists personalize diets to each persons needs and tastes while still hitting nutritional requirements.

Something that sometimes we have felt is that the nutrition field has been focusing too much on nutrients rather than on foods, Ordovs said.

Previous studies have been looking at genes that were associating with higher protein intake or higher fat intake or higher carbohydrate intake, Ordovs said. But this study is more aligned with the fact that people eat foods. They dont just eat proteins, carbohydrates and fats. People tend to eat within a specific pattern.

Further research is needed to explain an exact balance between genetic predisposition and volition when it comes to food choices in different groups of people, but Okada suggests that by estimating individual differences in dietary habits from genetics, especially the risk of being an alcohol drinker, we can help create a healthier society.

The-CNN-Wire & 2020 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

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Prefer Tea Over Coffee? It Could Be Your Genes, Study Finds - CBS Baltimore

Dr Jane Cooke Wright whether youve heard of her or not, her research changed the path of oncology, paving the way for cancer treatment as we know it.In a time when medicine and research were predominantly white and male, Jane and her family had challenged the preconceptions of what a scientist should be. Jane and her sister, Barbara, represented the third generation of Wright family medics; the tradition began with their grandfather, who, after being born into slavery, later graduated from Meharry Medical College as valedictorian of his class. Their father, Dr. Louis Tompkins Wright, was one of the first African-American graduates of Harvard Medical School and founded the Harlem Hospital Cancer Research Foundation (HHCRF).

After briefly considering the idea of pursuing an art degree, Wright graduated with honors from New York Medical College and in 1949 began working with her father at the HHCRF.

Chemotherapy wasnt always one of the go-to approaches for cancer treatment. In the early to mid-20th century, using drugs to treat cancer was considered somewhat experimental, only to be used if other treatment avenues had been exhausted. Despite the hesitant attitudes towards chemotherapeutic agents, Wright and her colleagues made many strides towards establishing chemotherapy as a viable treatment for cancer.

One of the most significant came in 1951; Wright led a seminal piece of research that laid the foundations for treating solid tumors chemotherapeutically.1 The study primarily established the efficacy of methotrexate, a folic acid antagonist, in treating breast cancer, which was a major result in itself. However, it also demonstrated the long-term efficacy of combination therapy and adjustment of treatment regimens according to the individual patients symptoms of toxicity. Methotrexate continues to be used to this day, alone or in combination, to treat a range of cancers from head and neck to non-Hodgkins lymphoma.

Adjusting treatment according the individual was an idea forming the basis of much of Wrights research, representing some of the early steps towards personalized medicine. Whilst previous researchers had used mice tumors as a model for predicting response to different chemotherapeutics, Wright and her colleagues cultured tumor tissue taken from patients. Once grown, the primary cultures were treated with a variety of chemotherapeutic agents and their response was assessed. In doing so, Wright helped to develop a method for testing and selecting the most effective course of chemotherapy for a particular tumor in an individual patient.2

The solution came in 1964, in the form of the American Society of Clinical Oncology (ASCO), of which Wright was a founding member and notably, the only woman of the founding group. In a 2010 interview, Wright explained why the society was created:

Our goals were to bring about a set of standards for a clinical oncology specialty, to enlarge the area of knowledge in the field and to ensure that vital information was readily available and disseminated.3Wright set out to achieve these goals during her tenure as associate dean and professor of surgery at her alma mater, New York Medical College, developing cancer treatment guidelines and a program teaching doctors how to use chemotherapy. Her appointment to the position was also a significant social feat at the time; upon taking office in 1967, Wright became the highest ranked African American woman at a nationally recognized medical institution. This was only one of a number of high-ranking positions held by Wright over the next 20 years.

In a 2011 interview, Wrights daughter, Alison W. Jones, PhD, gave an insight into how her mother achieved so much in a time and society which often had preconceptions of what a womans life should be. She never looked at things as obstacles, Jones explained. She looked at them as challenges and I think that she was a very ambitious person and I think that she never let anything stand in the way of her doing what she wanted to do.

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Jane C. Wright: The Woman Who Changed the Landscape of Oncology - Technology Networks

It has been one year since Alex Trebek announced his stage IV pancreatic cancer diagnosis.

The Pancreatic Cancer Action Network (PanCAN), a leading patient advocacy organization dedicated to fighting the worlds toughest cancer, is extremely grateful to him for his continued openness about his treatment journey and more importantly, his strength and resolve to fight for all who look to him for inspiration.

Throughout the past year, Trebek has transformed the conversation around pancreatic cancer and provided hope to people impacted by this disease.

In his latest health update, Trebek mentioned that he is one of the 18.4% of patients with stage IV pancreatic cancer to hit the one-year survival mark. This is a significant milestone for someone with this diagnosis.

PanCAN is hopeful that others will have similar outcomes.

The good news is that today we know that some patients are living beyond this milestone as a result of progress happening in the field.

Earlier this week, PanCAN announced new research that revealed pancreatic cancer patients who receive precision medicine live an average of one year longer than those who do not. This is the first study to demonstrate an overall survival benefit from precision medicine in pancreatic cancer patients.

PanCAN recommends that all pancreatic cancer patients undergo testing of both their tumor tissue (molecular profiling) and blood or saliva for genetic (germline) changes to determine if they have an actionable alteration and to identify treatment options for that patient.

PanCAN offers a free Know Your Tumor precision medicine service as well as free, in-depth, and personalized resources and information on the disease. Patients can contact our Patient Central today by calling 877-2-PANCAN (877-272-6226) M F, 7 a.m. 5 p.m. PT or emailingpatientcentral@pancan.org

We continue to work tirelessly for Trebek and the thousands of patients that are diagnosed every year with pancreatic cancer. And we are pleased to report that there has been other tremendous progress in just the last three months that offers patients much hope.

Every pancreatic cancer patient and every tumor is unique. We will continue to work hard to make sure all patients have access to free, personalized information and resources to increase their likelihood of a positive outcome. And we hope that Trebek continues to do well.

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Statement from The Pancreatic Cancer Action Network (Pancan) In Response to Alex Trebek's Health Update - Pancreatic Cancer Action Network -...

Drug testing and screening for cancer drug discovery can take years and the 2D cell cultures and animal models used to estimate their efficacy before reaching human trials are often not representative of the human body, which is why researchers are turning to bioprinting technologies to increase the success rate during human trials by providing human-specific preclinical data. In 2018 there were 17 million new cases of cancer worldwide, and the disease is expected to affect 27.5 million people each year by 2040, this high incidence level makes tackling the disease enough of a reason for researchers to consider new technologies that could accelerate drug discoveries and screenings. Although still in its lab phase, a new development that uses immersion bioprinting of human organoids could change 3D drug screening.

Researchers from Cornell University, Wake Forest School of Medicine, Virginia Polytechnic Institute and State University and The Ohio State University have published an article in Micromachines, demonstrating an immersion printing technique to bioprint tissue organoids in 96-well plates to increase the throughput of 3D drug screening. Using a hydrogel bioink comprised of hyaluronic acid (HA) and collagen they were able to bioprint it into a viscous gelatin bath, which blocks the bioink from interacting with the well walls and provides support to maintain a spherical form.

According to the article, the use of bioengineered human cell-based organoids may not only increase the probability of success during human trials, but they could also be deployed for personalized medicine diagnostics to optimize therapies in diseases such as cancer. However, they suggest that one limitation in employing organoids in drug screening has been the difficulty in creating large numbers of homogeneous organoids in form factors compatible with high throughput screening, so bioprinting can be used to scale up the deposition of such organoids and tissue constructs.

The team of scientists employed two commercially available bioprinters to evaluate the compatibility of the collagen-HA hydrogel and the HyStem-HP hydrogel: Cellinks INKREDIBLE bioprinter and Allevis Allevi2 bioprinter. This method was validated using several cancerous cell lines and then applied to patient-derived glioblastoma (GBM) a fast-growing brain tumor and sarcoma (or malignant tumor) biospecimens for drug screening.

For the initial analysis of hydrogel biocompatibility, researchers used two common cell lines: human liver cancer and human colorectal cancer.

While carrying out patient-derived tumor biospecimen processing, they obtained two glioblastomas and one sarcoma biospecimen from three surgically treated patients in adherence to the guidelines of the Wake Forest Baptist Medical Center IRB protocols. These biospecimens were processed into cell suspensions, successfully yielding millions of viable cells from each sample. The cells were then combined with the collagenHA bioink for deployment in immersion bioprinting. After bioprinting, the GBM and sarcoma patient-derived tumor organoids (PTOs) were maintained for seven days in the incubator, after which a chemotherapy screening study was initiated.

Schematic of the printing process using 2 bioinks in two commercially available bioprinters: Cellink Inkredible and Allevi 2 (Image: Cornell University/Wake Forest)

The researchers claim that while their PTOs have been useful for disease modeling, mechanistic study, and drug development, they have also used these models in a diagnostic sense to influence therapy, which might just be the ultimate goal of their work.

This 3D bioprinting approach called immersion bioprinting is an efficient way to surpass the limitations that have plagued tumor organoid systems. The experts, in this case, suggest that there have been few advances in regard to approaches to the printing process itself, or generation of novel, more user-friendly bioinks. Indicating that unfortunately, many bioprinting studies are somewhat repetitive, falling back on traditional biomaterials and their crosslinking approaches, which were never developed to be bioprinted or to accurately represent the complexities of the native ECM (extracellular matrix).

Results of the published study suggests that the realization of this technology that can fabricate PTOs in a consistent and high-throughput fashion will provide a valuable ex vivo/ in vitro tool that can be deployed for many subsequent studies, including target discovery, mechanistic investigation of tumor biology, drug development, and personalized drug screens to aid in treatment selection in the clinic.

Clinical oncology is faced with some critical challenges during this decade, from inefficient trial design to integrating new technologies in diagnostics and drug trails. However, advances in new methodologies, from hardware design to improved bioinks developed specifically for bioprinting, are opening up new opportunities for bioprinting-based applications. This new study, in particular, suggests that with advances in bioprinting hardware, software, functional ECM-derived bioinks, and modifications to printing protocols, bioprinting can be harnessed not only to print larger tissue constructs, but also large numbers of micro-scaled tissue and tumor models for applications such as drug development, diagnostics, and personalized medicine.

Employing bioprinted patient-derived tumor organoids in a clinical precision medicine setting (Image: Cornell University/Wake Forest)

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New Method: Immersion Bioprinting of Tumor Organoids Will Increase the Throughput of 3D Drug Screening - 3DPrint.com

Lee Carmen, Associate VP for Information Systems and CIO, University of Iowa Health Care

Lee Carmen, Associate VP for Information Systems and CIO, University of Iowa Health Care

Lee Carmen was appointed associate vice president for information systems in July 2007. Carmen oversees information technology services, including technical support, applications development, and clinical applications across the University of Iowa Health Care enterprise

As a CIO, what are some of the recent trends that you see in the healthcare space?

As the CIO of a large Midwestern quaternary care medical center, I have expertise in varied domains from electronic medical records (EMRs) and clinical systems to security, networking, data management, and analytics. As far as the recent trends are concerned, with the advent of technologies like artificial intelligence, healthcare organizations are highly interested in partnering with companies that have experience in managing and analyzing large data sets.

How do you keep abreast of the innovative technologies entering the healthcare space?

Fortunately, the information architecture at Iowa is quite similar to the architectures at peer institutions. They not only have the same EMR solution but also analytics tools, nurse call systems, clinical monitoring systems, allowing us to collaborate, inform and advise each other on new technology advances and implementations. To leverage more from this professional networking, we interface with our key vendor partners for EMRs,or clinical equipment and our ERP partners. We engage the early adopters of emerging technologies to reap the benefits of the services today as well as in the future. Being an academic medical center, we have many nationally recognized researchers, who share new technologies of interest or value with us. To gain more insight into the ever-evolving technology landscape, we keep an eye on the new patents being released, the venture capitalists funding, and the IPOs from a business angle.

What is your checklist for choosing technology vendors?

Many IT companies today have limited experience in healthcare operations, so one of the first things we check is the vendors experience in the space based on the customers they are currently working with. Since we operate with 850 beds, generating yearly revenue of $2.5 billion, a vendor for a 100-bed community hospital might not be a match. However, we further look at their viability, operational tenure, and funding model. Our team of security, data architecture, data networking, and user design experts works closely with the vendor, to ensure they both are on the same page of design, scalability, and architecture.

As we expand our technology footprint in a healthcare setting, we also need to train our workforce for implementing and supporting the technicalities

Elaborate on some of the current projects that you are currently overseeing, and what impacts do you hope to get out of them?

With provider productivity, efficiency, and burnout being the hot issues today, the introduction of additional technology into clinical settings can often have a negative effect on the healthcare providers. To ensure that the technology we bring in is a net benefit instead of a net detriment to the providers, we focus on designing, configuring, and implementing systems in a way that supports their everyday workflows.

While many new players are making their way into the healthcare communication space, there are established vendors refreshing their product lines on-the-move. Looking at the communication between clinicians and patients during treatment, we evaluate whether the tools in place are adequate to meet the care delivery needs, or do they need modernization. We provide patients with self-service tools, enabling them to schedule appointments and ask questions of their providers. We are configuring our existing enterprise systems to allow them to take inpatient data from network-enabled devices such as Apple watches or glucose monitors. Further, the next step is to augment this collected data in a safe, scalable, secure way that is relatively easy for our patient population to access.

Do you have any additional highlights on the challenges persistent in the healthcare arena?

There is a never-ending challenge to recruit talented technology professionals in the healthcare space. As we expand our technology footprint in a healthcare setting, we also need to train our workforce for implementing and supporting the Technology.

What are some of the leadership principles that you abide by to influence your peers and subordinates?

I believe I am here to work for my staff, rather than having them work for me. My role is to communicate between other leaders in the organization and my team about the strategic direction and operational needs of the company and accentuate areas of focus. Understanding my teams requirements in terms of direction and resources to further meet the organizational needs, I act as a buffer between these two parties. I also attempt to remove the barriers for my technology teams, allowing them to bring out the best of their abilities and get solutions into production, as timely as possible. In addition, my responsibilities include working with and advising our executive leadership team on what we could develop or implement to support the growth of the organization.

How do you think the future of healthcare would turn out to be?

With healthcare in rural settings being a big issue for us, projecting forward, the focus will be on the telemedicine space and on the ability to deliver and receive care from providers at any geographic location convenient for the patient. Besides the advances in automation, we will be witnessing the rise of technology-enhanced alternate care delivery models, which will be different from visiting a physical clinic or an emergency room. At our organization, one of our physician-researchers has developed the first FDA approved AI device that screens patients for diabetic retinopathy by taking images of their eye and running it through an AI engine for a clinical interpretation. This device cuts down the physician's need to diagnose, freeing up their time to focus on more complex areas. Besides the development of tools like EMRs to accept different types of data inputs, advancements are occurring in the personalized medicine space and the ability to find diagnosis and treatment strategies for patients based on their unique requirements, all driven by data.

What is your advice to an aspiring CIO of a healthcare establishment?

Healthcare organizations are unique places to work in as you are surrounded by some of the smartest, most dedicated, and hard-working members of our society, such as doctors, nurses, pharmacists, and others. My advice to the junior staff is to take advantage of the environment they are working in, and understand how every different person and team interacts with a patient. Be it an outpatient world, an inpatient one, an emergency room, an intensive care unit, or an operating roomall come with different requirements; you need to be exposed to different health care delivery areas to understand its nuances. Aspiring healthcare IT professionals need to listen and absorb everything from the various clinical settings as it will have a significant impact on the services that they can ultimately deliver back to the organization.

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Keeping Up with the Change in Healthcare - CIOReview

Most development-stage biopharmaceutical companies pin their hopes on a single clinical hypothesis evaluated with a handful of drug candidates at best. Fate Therapeutics(NASDAQ:FATE) is not most early stage companies.

The cellular therapy pioneer is developing 13 unique pipeline programs. That may give the impression that Fate Therapeutics is throwing everything at the wall and seeing what sticks, but a closer look shows there's been a rational build-out of the pipeline. That doesn't necessarily mean all of the hypotheses will work -- development-stage biopharmas are inherently risky investments -- but if the lead clinical programs report promising data in 2020 from the next wave of major trials, investors might begin to see the value of the company's vision.

Here's why this pharma stock is my top buy in March.

Image source: Getty Images.

Fate Therapeutics has staked its future on the general idea that first-generation immunotherapies leave much room for improvement. It's not wrong. The successful development of chimeric antigen receptor (CAR) T cells put cellular therapy on the map a few years ago, but there are inherent limitations to their production and use.

Take Yescarta as an example. In the second half of 2017, it became the second CAR-T drug to earn approval from the U.S. Food and Drug Administration (FDA). It's a personalized medicine used to treat certain cancers of white blood cells. To make a dose, immune cells are harvested from a patient, isolated, genetically engineered to attack the patient's cancer, multiplied in the lab, and then administered back into the patient.

The immunotherapy is highly effective. In a large post-approval study involving 533 individuals, Yescarta achieved an overall response rate of 84% and a complete response rate of 66%. That means 84% of individuals responded to treatment and 66% of individuals had no evidence of disease after six months. The study proved why Gilead Sciences was wise to acquire Kite Pharma, which developed Yescarta and pioneered CAR-T therapies.

But first-generation immunotherapies such as Yescarta have limitations. Using donor- or patient-derived cells increases the complexity of treatment, which increases costs and the potential for errors. Manufacturing a dose of a patient-derived CAR-T therapy can take two to three weeks and cost $425,000. Hospitals administering CAR-T therapies can charge as much as $1.5 million to ensure they aren't losing money while adhering to stringent protocols.

CAR-T therapies can also cause severe side effects including cytokine release syndrome (CRS) and neurotoxicities (Yescarta comes with a boxed warning for these side effects). They can only be dosed once. And engineering them with first-generation gene editing tools such as CRISPR/Cas9 has been found to be error-prone. Fate Therapeutics thinks there's a better way.

Image source: Getty Images.

Fate Therapeutics is developing cellular therapies that address most of the concerns of first-generation CAR-T therapies.

Rather than rely on cells derived from each individual patient, the company engineers cells from a master clonal cell line. That allows for an off-the-shelf drug product that can be easily reproduced, confidently characterized for quality control, and efficiently manufactured in batches. The company estimates its manufacturing cost is less than $2,500 per dose. Individuals can also receive treatment in an outpatient setting and avoid racking up massive hospital bills.

The development-stage biopharma is also relying mostly on natural killer (NK) cells, which have several advantages compared to CAR-T cells.NK cells shouldn't be accompanied by severe side effects such as CRS or neurotoxicities, can rally the rest of an individual's immune system to attack tumors, and can be dosed multiple times to extend the duration of response. It's also possible to combine NK cells with other drugs, especially monoclonal antibodies, which could provide unique synergies to improve patient outcomes.

Fate Therapeutics has also tapped Inscripta's novel CRISPR gene-editing tool, which uses a novel cutting enzyme that has been shown to be more efficient than Cas9. That's important for ensuring all cells used for a drug product are homogeneous, rather than a distribution of cells with varying genetic profiles and levels of activity.

On paper, the company's approach stacks up favorably against a general first-generation cellular therapy.

Metric

First-Generation Cellular Therapy

Fate Therapeutics

Starting material

Cells derived from patient

Cells derived from master clonal cell line (nine of 13 clinical programs)

Manufacturing process

Complex process required to make a single dose

Manufactured in batches (many doses from one production run)

Manufacturing time and cost

2-3 weeks and $450,000

Available off the shelf and less than $2,500

Engineering tools

Error-prone first-generation CRISPR/Cas9 tools

Next-generation CRISPR tool using MAD7 enzyme is more efficient than Cas9 (first drug candidate could begin trials in 2020)

Cell type and dosing

CAR-T cells that can be dosed only once

Mostly NK cells that can be dosed multiple times (eight of 13 clinical programs)

Side effects

CRS and neurotoxicities

No cases of CRS reported in early studies of NK cells

Data source: Fate Therapeutics.

The benefits on paper are nice, but investors will be more concerned with how the approach stacks up in the real world -- and 2020 might be the year they get an answer.

Fate Therapeutics is developing cellular therapies against a range of solid tumor cancers and blood cancers. The company made six presentations at the American Society of Hematology (ASH) annual meeting in December, which provided investors with the first real glimpse of the pipeline's potential.

The takeaways were mostly positive and certainly raised the level of intrigue on Wall Street, as evidenced by a rising stock price. Fate Therapeutics notched several industry firsts (such as with FT500, which became the first off-the-shelf derived NK cell therapy to begin a clinical trial) while setting the stage for more important data readouts in 2020.

Drug Candidate, Cell Type

Indication

Last Update

FT516 (monotherapy), NK cell

Acute myeloid leukemia (AML)

First patient received one cycle of three once-weekly doses, had no evidence of disease in bone marrow at Day 42.

FT516 (combination therapy), NK cell + monoclonal antibody

B-cell lymphoma

First patient received one cycle of three once-weekly doses, no data reported.

FT500 (monotherapy or combination), NK cell or NK cell + checkpoint inhibitor

Advanced solid tumors in individuals who failed prior checkpoint inhibitor therapy

12 patients total, six of 11 evaluable patients achieved stable disease after first cycle, no cases of CRS or neurotoxicity in 62 total doses.

Data source: Fate Therapeutics Press releases.

Fate Therapeutics also plans to initiate new studies in 2020. A combination therapy comprising a FT596 (an NK cell drug candidate) and rituximab (a monoclonal antibody) is expected to begin a phase 1 study in lymphoma in early 2020. Meanwhile, the company expects to submit investigational new drug (IND) applications for its first off-the-shelf CAR-T cell product, FT819, and first CRISPR-edited product, FT538, in the second quarter of this year.

Fate Therapeutics began the year with $261 million in cash, which means investors and Wall Street analysts will be solely focused on clinical results and the continued buildout of the pipeline in 2020.

While all development-stage biopharma stocks are inherently risky, the number of shots on goal insulates investors from a single failure. In fact, each drug candidate is genetically engineered against unique molecular targets, or used in specific combinations, which means any single clinical failure can't be extrapolated across the entire pipeline.

Fate Therapeutics still needs to generate clinical results demonstrating its next-generation approach to cellular therapy can lead to robust clinical benefits for patients, but Wall Street and deep-pocketed industry leaders might coalesce around the development-stage company if early and mid-stage studies continue to impress. That could make its current $2.3 billion market valuation a bargain for investors with a long-term mindset -- and with an appetite for above-average risk.

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Here's My Top Stock to Buy in March - Motley Fool