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‘Cyberpunk 2077’ Delayed as CD Projekt Red Polishes ‘Crowning Achievement’ Over ‘Witcher 3: Wild Hunt’ – Newsweek

Posted: January 20, 2020 at 5:45 am

Cyberpunk 2077, originally planned for an April 16 release date, but has now been delayed until September 17, developer CD Projekt Red announced on Thursday.

In a statement posted to social media, the Cyberpunk developer did more than announce the delay, further describing just how far along the game is in its development. According to CD Projekt Red, the game is currently "complete and playable," throughout its open world setting of Night City. Instead of core story, content or environmental changes, the delay is primarily motivated by the need for additional "playtesting, fixing and polishing."

Indicating their confidence in the game they've created, CD Projekt Red also set a bold goal for Cyberpunk 2077: topping their own critically acclaimed Witcher 3: Wild Hunt to become their "crowning achievement" in the current console generation. Witcher 3 is often named among the best open world games and best RPGs ever createdit's not even uncommon to hear Witcher 3 named as the best game ever made. So while Cyberpunk 2077 has a lot to live up to, its delay announcement suggests CD Projekt Red feels as if they're near to realizing their complete vision.

CD Projekt Red also promised more frequent updates on the game's progress, particularly as the revised release date approaches.

In Cyberpunk 2077, players start off in Night City as V, a customizable mercenary who acquires transhumanist enhancements throughout the game. Night City is a gigantic corporate-controlled metropolis in the Free State of California, with six different regions for players to explore, each with their own rival factions and gangs. Along the way, players are guided by Johnny Silverhands, a digital ghost played by Keanu Reeves, who haunts the player and nudges him or her towards his own objectives.

Signed by CD Projekt Red co-founder Marcin Iwiski and the head of studio, Adam Badowski, the full statement reads:

"We have important news regarding Cyberpunk 2077's release date we'd like to share with you today. Cyberpunk 2077 won't make the April release window and we're moving the launch date to September 17, 2020.

We are currently at a stage where the game is complete and playable, but there's still work to be done. Night City is massivefull of stories, content and places to visit, but due to the sheer scale and complexity of it all, we need more time to finish playtesting, fixing and polishing. We want Cyberpunk 2077 to be our crowning achievement for this generation, and postponing launch will give us the precious months we need to make the game perfect.

Expect more regular updates on progress as we get closer to the new release date. We're really looking forward to seeing you in Night City, thank you for your ongoing support."

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The Old Guy: On a healthy way of life for my generation – SILive.com

Posted: January 20, 2020 at 5:44 am

STATEN ISLAND, N.Y. -- I never get sick anymore. So, when a bug caught me right before Thanksgiving, I was both annoyed and worried. Getting sick before a family holiday is a big drag, because you want to be with your family, you just dont want to leave them with whatever it is youve got.

When I taught, I was constantly ill. Kids are mobile petrie dishes. I even developed pneumonia from my kids once, a fact my then Principal seemed unaware of when she questioned my six day absence. She also seemed unaware that pneumonia is contagious.

...Sigh...

I dont miss being in that type of environment. I do miss my kids, especially around the holidays.

I read on the WeAreTeachers Helpline Facebook page recently that administrators seemed to be coming out of the walls at one school, making surprise visits into classrooms. Probably looking to catch somebody with their feet on their desk showing a video, like in that movie Bad Teacher.

Yeah. Cause, you know, the day ends at three and we have summers off.NOT!!!

I always played it a bit looser during the holidays because I love celebrations. And, for some of my kids, family holidays werent always that great. So, we created an alternate family in our room. We ate food and watched movies and wrote about the holidays. And, we laughed. A lot. Because, laughter is the way to a persons heart.

And, I mean, you really had to laugh. Here we were, fifteen kids and one teacher stuck in a windowless room by the gym. Hardly anybody knew where we were, unless we called for help. We were an island unto ourselves.

And, I was trying to show my kids how to celebrate. For a lot of them, life was hard. Learning should be both rigorous and joyful. It should never be difficult.

I cant get over the fact that, when I was working, staff were encouraged to come in sick, which is a huge mistake. Youre not at your best, and you need to be because teaching is totally unpredictable. Secondly, youre exposing your kids to germs as well as receiving several handfuls from them. Bad, all the way round. Im glad that the effort to ensure paid sick days is gathering steam. And teachers have 10 sick days a year, which is one a month. But, as one principal told me, that doesnt mean you should use them.

...Sigh...

A teachers job is not to make things easier for their administrator. It is to teach their students how to become compassionate, intelligent, mature individuals in a complex world. Anything else is just window dressing or worse.

So much for Memory Lane. Back to aging.

What are the risk factors for people over 65? According to WHO (The World Health Organization), theres a lot to be concerned about. Injury due to falls is high up there. Patterns of what they term harmful behavior can lead to illnesses later on. Five chronic conditions (diabetes, cardiovascular disease, cancer, chronic respiratory diseases and mental disorders) account for 77% of illness and 85% of death rates. Poverty is higher among older women than older men. Social isolation and exclusion and elder maltreatment often occur.

So, what can we do to stave all of this off? As you know, Im a big believer in preventative medicine, seeking help and treatment before the problems arise. I also believe strongly in acupuncture, chiropractic medicine, massage therapy and good oral health care. All of these factor into general wellness and a breakdown in any part of your system as you age can also affect other areas of your body.

A friend who is exactly 24 hours younger than me (we were born in the same hospital 24 hours apart and only met in 1977!) told me recently he had pneumonia and bells went off in my head. I told him post haste to seek treatment and that pneumonia was nothing to **** with. Trust me, it only gets worse with age, as many things do.

I dont want to sound alarmist, but if we dont take extraordinary care of ourselves now, we wont be around for the really great things in life like grandchildren, cruises, binge watching Netflix and just doin nuthin. This is the time of our lives when all that and more should be available to us and well want to take advantage of them. But, to paraphrase a Billy Joel tune, no sense having an expensive car if you cant drive it because your back problems are too severe.

You have to get proactive because, sadly, our health care system in America is profit driven and there is no profit to be made in a cure. So it benefits certain parties if we all remain sick.

The best way to care for yourself is to listen to your body. You pretty much know when things are off, much as you do with the car you drive. If something feels amiss, have it checked out. Better a false alarm than alarming news.

Be kind to yourself and to others. And, hold those grey heads up!

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Bipartisan legislative group forms Arkansas Early Childhood Well-Being Caucus – talkbusiness.net

Posted: January 20, 2020 at 5:44 am

Republican and Democratic Arkansas lawmakers formed a new legislative caucus focusing on early childhood well-being. The caucus will work with early childhood advocates to create an agenda for the 2021 Arkansas General Assembly.

The Arkansas Early Childhood Well-Being Caucus will be chaired by Sen. Trent Garner, R-El Dorado, and Rep. Denise Garner, D-Fayetteville. Bipartisan members from the Senate and the House have joined the caucus.

During my career as a nurse practitioner and advocate for behavioral sciences and education, Ive learned the importance of early intervention to insure the best outcome, Rep. Garner said. As around 80% of a childs brain is developed by age 3 and 90% by age 5, its imperative to make certain our children are receiving everything they need to thrive and that we have policies in place to help make that happen.

As a son of a kindergarten teacher, I saw firsthand the importance of early childhood development, Sen. Garner said. Im excited to be part of this group of bipartisan legislators who are working together to move Arkansas in a new and better direction for our children.

There are more than 190,000 children in Arkansas under age 5.

The new caucus will spend the next several months hearing from experts on brain development, nurturing environments, and the impacts of social determinants of health outcomes.

The caucus held its first meeting Thursday (Jan. 16) with 16 legislators in attendance. The meeting featured a presentation on Brain Development by Dr. Nikki Edge, Professor in the Department of Family and Preventative Medicine at UAMS and a presentation on Prenatal to Age 3 by Jamie Morrison Ward, President of the Arkansas Association for Infant Mental Health.

We are thrilled with the opportunity to raise awareness and educate Arkansans on the critical developmental period of prenatal to age 3, said Ward. The formation of the Early Childhood Well-Being caucus is a testament to the importance of the early years, and we are very fortunate to have a legislature that is interested in learning how to positively impact the health and education of our states youngest citizens and their families.

The caucus plans to meet every month or every-other month.

In addition to Garner and Garner, members of the caucus include: State Senators Bruce Maloch, D-Magnolia; Greg Leding, D-Fayetteville; Keith Ingram, D-West Memphis; Will Bond, D-Little Rock; State Representatives Tippi McCullough, D-Little Rock; David Whitaker, D-Fayetteville; Jay Richardson, D-Fort Smith; Don Glover, D-Dermott; LeAnne Burch, D-Monticello; Andrew Collins, D-Little Rock; Dan Douglas, R-Bentonville; Chris Richey, D-West Helena; DeAnn Vaught, R-Horatio; Cindy Crawford, R-Fort Smith; Jeff Wardlaw, R-Warren; and Jon Eubanks, R-Paris.

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Entering the Next Phase of Value-Based Care, Payment Reform – RevCycleIntelligence.com

Posted: January 20, 2020 at 5:44 am

January 17, 2020 -What healthcare providers really want is to do is the right thing for their patients. They just need sustainable financial support for doing that, health economist Mark McClellan, MD, PhD, said at the start of an interview with RevCycleIntelligence.

The healthcare industry has in earnest attempted to transform not only clinical outcomes, but also the financial aspect of care for about a decade now. Yet progress with the adoption of alternative payment models (APMs) has been slow, explained McClellan, the former CMS administrator and current Robert J. Margolis MD Professor of Business, Medicine and Policy, Fuqua School of Business.

One in three healthcare payments flows through an APM, the Health Care Payment Learning & Action Network (LAN) which McClellan also serves as co-chair for their Guiding Committee recently found using the latest data from 62 health plans, seven fee-for-service Medicaid states, and traditional Medicare.

But fee-for-service still dominates even a decade later.

According to LANs data, approximately 39 percent of healthcare payments made in 2018 were under fee-for-service. Another 25 percent were fee-for-service with some link to quality and/or value. These payments included pay-for-reporting or pay-for-performance incentive payments.

The general consensus in healthcare is that fee-for-service is one of the primary reasons why the industry is sinking. The financing mechanism encourages providers to protect their bottom lines by delivering more services, which results in unnecessary costs and utilization, as well as a sick care system.

APMs aim to get the healthcare system back to one that incentivizes just that health. The models tie provider reimbursement to the value of care, meaning providers get paid based on their patient outcomes and/or costs.

So, what is preventing widespread adoption of the models that promise to fix healthcare? And what needs to be done to hit the value-based tipping point? RevCycleIntelligence spoke with McClellan and other industry experts, as well as those on the frontline of value-based care, to explore the state of payment reform and strategies for progress.

The status quo is no longer working in healthcare.

National healthcare spending increased to $3.6 trillion in 2018 and is slated to reach nearly $6 trillion in the next seven years. Meanwhile, patients are not seeing the benefits of greater healthcare spending. According to data from the Kaiser Family Foundation, the US lags behind similarly wealthy countries. In some cases, such as with rates of all-cause mortality, premature death, death amenable to healthcare, and disease burden, the US is not improving as quickly as their peers.

The failings of the current healthcare system are not new to healthcare stakeholders, but there is a fresh push to fix the problems, according to Theresa Dreyer, MPH, lead of value-based care at the Association of American Medical Colleges (AAMC).

There's a new urgency as the cost of care continues to increase to really adopt some ideas that have been existing in the market for decades and apply them to broader and broader patient groups, she said.

Those ideas? Value-based care.

One of the things that we see out of our teaching hospitals is a real readiness to understand that the status quo may not be the way that healthcare is provided going forward, said Dreyer, who leads three AAMC collaboratives for teaching hospitals that participate in alternative payment models. Many organizations see value-based care as a way of continuing to invest in the clinical changes that they are dedicated to.

While most hospitals and physicians feel that value-based care is the right thing to do for their patients, the stakeholders are not getting on board with the vehicles being used to convey value-based care.

Harold D. Miller, president and CEO, CHQPR

The data shows that the healthcare industry is about a third of the way with adopting a value-based reimbursement system. But the data does not tell the whole story, Harold D. Miller, president and CEO for the Center for Healthcare Quality and Payment Reform argued.

We have moved backwards rather than forwards, said Miller, a former member of the federal Physician-Focused Payment Model Technical Advisory Committee that was created by Congress to advise the HHS Secretary on the creation of APMs.

The payment models that are being used by and large are actually making things worse rather than better in most cases, he elaborated. They are very problematic for patients in many cases because they create incentives to reduce spending without appropriate quality protections built into them. They are forcing many small practices and hospitals out of business.

Physicians have been skeptical about accountable care organizations (ACOs), bundled payments, and other popular APMs. A 2018 survey of over 3,400 physicians found that many doctors (41 percent) feel value-based care and reimbursement will have a negative impact on patient care as a whole and many more (61 percent) feel the APMs will have a negative impact on their bottom lines.

Another survey published in NEJM Catalyst that same year also found that only about half of clinicians believe the alternative payment method will take off.

There is data to support their skepticism. A recent report from the non-profit Catalyst for Payment Reform showed that APMs in the commercial sector only realized small care quality improvements. Additionally, hospital readmission rates one of the most popular care quality metrics used in APMs barely improved under the value-based arrangements.

CMS has also expressed concerns about one of its largest APM demonstrations. According to the federal agency, the Medicare Shared Savings Program, which currently governs 517 accountable care organizations (ACOs), has actually increased Medicare spending.

We've learned in the last few years that it's not enough just to pay a healthcare provider fee-for-service and give them a little bonus or a penalty for doing something we think we'd like them to do, like buy an electronic record system or report on a quality measure, McClellan said.

Pay-for-performance, shared savings, and other similar APMs are a good place to start, but the models are not enough for sustainable, effective support for truly better care models that can improve outcomes and lower costs significantly, he added.

CMS and other major payers have started to recognize that APMs built on fee-for-service are not leading to the results they had hoped for a decade ago, and these stakeholders are refining their value-based care strategies to hold providers more accountable for outcomes as result.

After six years of experience, the time has come to put real accountability in accountable care organizations, CMS Administrator Seema Verma said in 2018 after announcing the agencys plan to revamp the Medicare Shared Savings Program.

What she meant by accountability was downside financial risk. In risk-based APMs, providers are accountable not only for the savings they achieve through the model, but also financial losses. If providers in APMs with downside financial risk exceed their spending benchmarks, they must repay a portion or all of the losses to the payer.

CMS sees financial risk as the future of value-based care, according to Dreyer. The agency believes that holding providers financially accountable for losses will result in more meaningful changes and outcomes.

However, downside financial risk may not be the key to unlocking value-based care success in APMs, industry experts contended.

The notion that somehow if you push financial risk onto physicians or hospitals, you are going to get better quality care or lower cost is just wrong. It is an insurer view of things, Miller said. The main issue with risk is that current APMs put providers at risk for outcomes they cannot control, he explained.

Miller pointed to APMs for oncology care as a prime example.

The biggest cost of cancer care is drugs and one of the places where you've seen the fastest increases in drug prices has been in oncology drugs, he said. It doesn't do anything to promote better care to try to put physicians at risk for that. What we have seen is small oncology practices going out of business because they can't afford to actually treat their patients and the payment models don't solve that.

Focusing the future of value-based care on risk-based APMs could also alienate many providers from the transition away from fee-for-service, Dreyer added.

There's a risk of leaving behind organizations that are newer on the value-based care journey, she said. The new models are focused explicitly on organizations that already have experience and if you don't already have this experience, it'll become harder and harder to enter into the market.

If risk-based APMs are not the appropriate next step for the value-based care transition, then what is? According to McClellan, the answer lies in episode- or population-based payments.

Source: Xtelligent Healthcare Media

APMs should be less about the level of financial risk involved and more about supporting the activities and infrastructure providers need to engage with value-based care, McClellan insisted.

What really works is giving healthcare organizations payments that are more tied to the people and the whole episodes of care that they are providing, he said.

Population- and episode-based payments give providers the flexibility they need to deliver care, he explained. With the flexible payments, providers can invest more resources into things like paying for team-based approaches to care or paying for services that aren't medical and weren't paid for under fee-for-service models.

But along with that, they do have more accountability for improving quality outcomes and keeping total costs of care down, he stressed.

Only about 5 percent of healthcare payments made in 2018 flowed through one of these models, LAN reported. And payers do not expect much growth in these types of payments. A survey of payers conducted by LAN found that payers expect the most growth in upside-only and two-sided risk APMs.

Mark McClellan, MD, PhD, co-chair of LAN's Guiding Committee

To progress with value-based care and related payment reforms, Miller suggested that the healthcare industry start with identifying a metric to improve. Successful APMs target opportunities to reduce spending or improve quality, which may include cutting spending on services with little benefit to the patient or avoiding complications of a specific treatment.

Payers and providers then need to identify changes in services, as well as barriers in the current payment system, that prevent changes in care delivery. Once stakeholders do that, they can design the APM to overcome the barriers and deliver higher-value care.

With an APM design, payers and providers must determine how to operationalize the model (i.e., create CPT/HCPCS codes and modifiers, determine patient eligibility, adjust payments for performance). Finally, stakeholders can implement the model, assess its performance, make improvements.

What sets Millers APM approach apart from others is his emphasis on changes in care delivery, which he believes will result in value-based care that leads to positive outcomes.

It's not the payment model that comes first, it's the care delivery, he said. And you have to know what the care delivery model is in order to know how to pay for it.

Source: Health Care Payment Learning & Action Network

The healthcare industry is not as far along the value-based care continuum as industry experts predicted a decade ago, and many believe reform is needed for current payment reform efforts. But those on the frontline of care delivery are still pushing forward with care and payment transformations in anticipation of a more advanced world.

With advancements in technology, healthcare is heading in a new direction. Community-oriented, coordinated, team-based care is now possible thanks to new and improved data sharing, consumer-facing healthcare apps, telemedicine, and other capabilities.

But fee-for-service does not align with this version of care delivery.

The right APMs can help providers develop the capabilities they need to deliver higher quality, lower cost care. For example, an ACO agreement enabled an independent primary care practice in Louisiana to get the data it needed to start performing wellness visits consistently, improve coding, advance chronic disease management, and other value-adding activities.

Darrin D. Menard, MD, FAAFP, local medical director for Aledades Louisiana and Southeast ACO

That, in turn, started increasing revenue, said full-time physician at the practice Darrin D. Menard, MD, FAAFP. Once the dollars from savings started coming in, that helped us go further with value-based care.

APMs have contributed to an uptick in, among many capabilities, preventative care and care management, population health management tool implementation, connected health use, and social determinants of health strategies.

But engaging with an APM to bolster care quality and lower costs is not easy for certain providers.

It's very difficult for an independent primary care practice to enter into the world of value-based care by themselves. Value-based care by definition is team-based care, Menard explained. I tried for many years on my own to work with Blue Cross to increase reimbursement for value-based care and I failed over and over again.

Gary Stuck, DO, chief medical officer at Advocate Aurora Health, knows about the benefits of size. Advocate Aurora Health is one of the largest non-profit health systems in the country, and its scale helped the health system to succeed in the Medicare Shared Saving Program, Stuck said in an interview.

But the chief medical officer attributed the health systems $61 million in savings to more than scale.

We use many strategies to get to that number, but the key here is that we focus on getting patients the right safe, high-quality care at the right time and the right place. We know that we can provide high quality care at a lower cost when we coordinate care across the continuum, he said.

Specifically, the health system has invested in expanding its integrated care management and post-acute care networks to optimize the control of chronic conditions and focus on the right level of care including a home-first mentality, Stuck stated.

Advocate Aurora Health also partners with a platform called NowPow to address the social determinants of health, which can impact between 10 and 20 percent of outcomes.

Gary Stuck, DO, chief medical officer, Advocate Aurora Health

Our care team members use it to screen for non-clinical barriers to good health and then make referrals to programs, accessing a database of thousands of community resources to help with transportation, food banks or other services, Stuck explained. Then, patients can be connected to the resources that better enable them to get on the road to better health.

Menard was able to break into this value-based world and start engaging in similar activities through an ACO, too. But his ACO was run by Aledade, which brought local primary care practices together to establish a value-based contract and help them implement value-based care.

They gave me the tools to become successful and then having their voice with the different insurance companies, said Menard, who eventually became the local medical director for Aledades Louisiana and Southeast ACO. The ACO gave us a whole team of practices across the state that we could actually finally move the needle on value-based care in a lot of these practices.

With access to infrastructure and resources, Menard is now part of a risk-based ACO and Track 2 of Medicares Comprehensive Primary Care Plus program. The practice leader plans to continue taking on risk through APMs, but he still had some suggestions for improvement.

For one, benchmarking that does not solely rely on historical expenditure data could help providers stick with APMs, he stated. Attribution could also use some improvement. When payers switch an enrollees primary care provider, that can knock those patients off of a small practices cohort of patients eligible for an APM. Additionally, new independent physicians starting out do not have the patient base necessary to engage in current APMs even if they are providing some of the best quality care around.

Current APMs may have some flaws, but providers are dedicated to continuing their journey to value-based care through the models.

Bottom line: We have embraced value-based care as a way to deliver better health. Advocate Aurora Health will continue to pursue whatever program makes the most sense for the system and our patients, Stuck said.

As they currently stand, APMs may not be perfect but industry experts and providers agree that value-based care is the future of healthcare. As provider organizations and payers prepare to take on more advanced APMs, the healthcare industry needs to step back and assess its progress with value-based care implementation thus far.

As Miller pointed out in his APM development guide, assessing and improving how to approach care delivery and payment reform is key. And these improvements will be critical to accelerating the transition to higher quality, lower cost care.

We need payment reform goals that are aligned with where we'd like to get, McClellan said, and hopefully, by 2025 not just by 2030 or 2035.

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Nevada cancer survivor found to have two different sets of DNA after bone marrow transplant 4 years ago – MEAWW

Posted: January 20, 2020 at 5:43 am

A Nevada man suffering from Leukemia received a bone marrow transplant from a donor, four years ago. Now, he has discovered he is a chimera: a rare condition where people live with two sets of DNA in their body.

The man named Chris Long, who works at the Washoe County sheriff's office in Nevada, learned of his condition after undergoing genetic tests, thanks to his colleagues from the forensics unit. "I thought that it was pretty incredible that I can disappear and someone else can appear," Long told The New York Times.

The procedure had replaced his blood DNA with that of his donor's. This is on expected lines, say experts. After bone marrow transplantation, patients have the donor's DNA in their blood.

But what left Long and his colleagues puzzled was the extent of infiltration in his body. The test revealed that the donor's DNA found its way into Long's cheeks, lips and semen.

"Any place blood cells can traffic could have traces of donor DNA present.The donor DNA, however, should not be the dominant DNA present in those other body areas," Dr. Timothy Fenske, Medical College of Wisconsin, told MEA WorldWide (MEAWW).

Patients who undergo the procedure are expected to have their own DNA in the vast majority of their cells. "We were kind of shocked that Chris was no longer present at all," Darby Stienmetz, Longs colleague told the New York Times.

However, Long has retained his DNA in the hair on his head and chest, where it has remained entirely unchanged.

Furthermore, according to experts, foreign DNA does not interfere with a person's identity. "Their brain and their personality should remain the same," Dr. Andrew Rezvani, the medical director of the inpatient Blood & Marrow Transplant Unit at Stanford University Medical Center, told the New York Times.

Neither will chimera's like Long pass on the donor's DNA into their future offspring, according to bone marrow transplant experts. "There shouldn't be any way for someone to father someone else's child," added Dr. Rezvani.

"I know of no evidence that marrow or blood stem cell transplantation could lead to chimerism in the actual sperm or eggs that would make no sense really.There must have been traces of DNA in the semen (semen is mostly prostatic fluid and not the same as sperm)," Freske told MEAWW.

Long's case could open up questions on the reliability of DNA tests which are considered unquestionable evidence during criminal investigations. When dealing with chimera's like Long, DNA tests could mislead investigations, said experts.

Nearly 23,000 bone marrow or umbilical cord blood transplants were performed in the US in 2017. And if one among them responded similarly to a transplant and that person went on to commit a crime, it could mislead investigators, according to Brittney Chilton, a criminalist at the Sheriff's Office forensic science division.

A case in point is one in Alaska. In 2004, investigators in Alaska recovered traces of DNA from a crime scene, which matched a profile on a criminal DNA database.

However, the match was to a man who was already in prison at the time of the assault. Later, the investigators realized that this man received a bone marrow transplant from his brother, who was eventually convicted.Scientists say that Long is a living, breathing case study of one, and it's impossible to say how many other people respond to bone marrow transplants the same way he did.

It is simply one of those curious possibilities that forensic analysts may want to consider when DNA results are not adding up, said people who have reviewed Long's case, as reported by The New York Times.

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Why stem cells could be the medical innovation of the century – World Economic Forum

Posted: January 18, 2020 at 7:50 pm

Right now, your bodys stem cells are working hard replacing your skin every two weeks, creating new red and white blood cells and completing thousands of other tasks essential to life. They are your own personalized fountain of youth.

Scientists generally agree that a stem cell should be able to do both of the following:

One theory of ageing suggests that between the ages of 30 and 50, our stem cells reach a turning point and start to decline in number and function. This results in the typical features associated with ageing.

There does not seem to be a single discoverer of stem cells. Accounts date back to the 1800s and even further, but the first successful medical procedure was a bone marrow transfusion in 1939. Advances in immunology led to donor matching, initially via siblings and close relatives. Unrelated donor matching flourished in the 1970s, alongside donor registries.

In the 1980s, scientists identified embryonic stem cells in mice, leading to the 1997 cloning of Dolly the Sheep. This created immense interest for human and medical applications and a backlash in the US as federal R&D funding was essentially halted in 2001.

In 2012, a Nobel Prize was awarded for the earlier discovery of induced pluripotent stem cells (iPS). Essentially, they return potency and self-renewal properties to mature non-stem cells, essentially making them act like stem cells again.

In the decade between 2010 and 2019, the first wave of stem cell start-ups emerged, alongside R&D programmes at many large pharmaceutical companies, leading to innovation and the first human clinical trials for iPS and other related therapies.

According to Q3 2019 data from the Alliance for Regenerative Medicine, there are 959 regenerative medicine companies worldwide sponsoring 1,052 active clinical trials; 525 of these companies are in North America, 233 in Europe and Israel, and 166 in Asia. In aggregate, $7.4 billion has been invested in regenerative medicine companies in 2019; $5.6 billion of which has been dedicated to gene and gene-modified cell therapy, $3.3 billion in cell therapy, and $114 million in tissue engineering.

Overview of the cancer stem cells market

Perhaps most excitingly, curative therapies are hitting the market and the results are astonishing: 60% of Acute Lymphoblastic Leukemia patients taking Novartis Kymirah showed a complete response (no traces of cancer) and were declared in full remission. Meanwhile, 75% of patients with Transfusion-Dependent -Thalassaemia treated with bluebird bios Zynteglo achieved independence from transfusions. Perhaps most astonishingly, 93% of spinal muscular atrophy patients treated with Novartis Zolgensma were alive without permanent ventilation 24 months after treatment. We should expect more medical breakthroughs in the coming years.

New science, new start-ups: several companies in the sector have gone public or been acquired. These exits led to the recycling of talent and capital into new companies. Because the science and commercial systems have also advanced, the companies in the next wave are pursuing bigger challenges, driving innovation, with even greater resources.

Patients are eager: the current market for stem cell therapies is growing at 36% per year, though it will rapidly expand when a breakthrough occurs toward the treatment of a non-communicable disease (such as cancer, diabetes, heart disease) or a lifestyle factor (for example, growing hair in the correct places, expanding cognitive abilities or increasing healthy lifespan).

New R&D models: funding is flowing into the sector from large companies, VC funds, and institutions such as the California Institute for Regenerative Medicine (CIRM) and New York State Stem Cell Science programme (NYSTEM). Some of the leading university R&D platforms include the Center for the Commercialization of Regenerative Medicine in Toronto, the Stanford Institute for Stem Cell Biology and Regenerative Medicine, the Oxford Stem Cell Institute, and most notably, the Harvard Stem Cell Institute (HSCI).

Founded in 2004, HSCI has established a phenomenal track record. It provided the first $200,000 in funding to Derrick Rossis lab, which inspired the largest biotech IPO to date. HSCI scientists were also co-founders or principals in the three most prominent gene-editing companies (CRISPR Tx, Intellia and Editas), the combined $1.55-billion True North/iPierian acquisitions and the recent $950-million acquisition of Semma Tx, Frequency Tx, Fate Tx, Epizyme Inc., and Magenta Tx.

For the casual investor, Evercore ISI is building a Regenerative Medicine Index, which may be the simplest way to build a portfolio. For institutions and those with deeper pockets, regenerative medicine funds are forming, including the Boston-centric Hexagon Regenerative Medicine Fund, which aims to create companies out of the Harvard Stem Cell Institute.

Caveat emptor. Though patients needs are immediate, those seeking treatments should think very carefully about the risks. There are many dubious clinics touting expensive stem cell treatments and some patients have experienced horrifying complications. Dr. Paul Knoepfler of UC-Davis has written a practical and scientifically accurate guide, a strongly recommended read if you or a family member are considering treatment or a clinical trial.

The leading causes of death in 1900 were mostly infectious/communicable diseases. While the prevalence of most causes has diminished, the largest increases include heart disease (+40%) and cancer (+300%). Granted, this is partly due to doubling life expectancy and a lack of death from other causes. However, given time and resources, scientists and physicians may cure these challenging diseases.

Total disease burden by disease or injury

Today, six of the seven leading causes of death are non-communicable diseases (heart disease, stroke, lung diseases, cancer, Alzheimers disease and diabetes). Based on the early promise mentioned above, regenerative medicine may be our best hope to solve the great non-communicable diseases of our time, and perhaps the single most transformative medical innovation in a century.

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The Clinical Trial that MS Patients Have Been Waiting For – Multiple Sclerosis News Today

Posted: January 18, 2020 at 7:50 pm

People with multiple sclerosis have been waiting for this: A full-scale clinical trial testing the effectiveness of stem cell transplantation as an MS treatment. The trial is being conducted by the U.S. National Institutes of Health, and its enrolling people with MSat several centers in the United States and one in the United Kingdom.

The U.S. has been behind the curve when it comes to approving stem cell treatments for people with MS. Autologous hematopoietic stem cell transplantation (aHSCT) has been available in Mexico and Russia for several years, but isnt widely available in the U.S.

In the procedure, doctors collect a patients blood-forming stem cells, give the patient high-dose chemotherapy to deplete the immune system, and then return the patients own stem cells to rebuild the immune system. The system, hopefully, returns free of cells believed to be involved with MS.

Three years ago, following a promising aHSCT study, Dr. Anthony Fauci was optimistic but cautious. Fauci is the director of the National Institute of Allergy and Infectious Diseases. He said, These extended findings suggest that one-time treatment with HDIT/HCT may be substantially more effective than long-term treatment with the best available medications for people with a certain type of MS. But Fauci emphasized that a larger trial was still necessary. It appears that trial has finally arrived.

The Phase 3 trial, called BEAT-MS (NCT04047628), will put aHSCT head-to-head against the top-line disease-modifying therapies (DMTs) available in the U.S. to treat MS.

It will enroll 156 adults, ages 18 to 55, with a diagnosis of relapsing-remitting MS (RRMS) at 21 sites 20 in the U.S. and one in the U.K. Participants will be randomly assigned to receive either aHSCT or one of the high-efficacy MS treatments currently in use: Ocrevus (ocrelizumab), Lemtrada/Campath (alemtuzumab), Tysabri (natalizumab), or Rituxan (rituximab). The participants, who wont know which treatment theyre receiving, will be followed for six years.

In a news release, investigators said they want to compare how much time elapses between the start of the treatment and an MS relapse. Theyll also compare the newly developing immune systems of the participants who receive aHSCT with the immune systems of those who receive a DMT.

Finally, theyll compare the effects of the two treatment types on other measures of disease activity and severity, their cost-effectiveness in terms of healthcare costs and productivity, and participants quality of life. We hope that BEAT-MS will clarify the best way to treat people with relapsing MS, said Dr. Jeffrey Cohen, the trials leader.

I hope so, too. A study such as this is long overdue. But I think I echo the feelings of many people with MS when I express dismay that were probably still at least six years away from approval of aHSCT in the U.S.

As I wrote three years ago, [S]cientists have been studying stem cell treatments for years and it sure seems as if were still crawling when we should be cruising. Also, why limit this study to people with RRMS? Why not include those with primary and secondary progressive MS? Am I wrong to think that they would benefit from aHSCT as much, if not more, as those with relapsing MS?

What do you think?

Starting this month, Multiple Sclerosis News Today columnist Jennifer Powell and I have begun recording MS news and feature stories in audio format. Jennifers audio reports are available on SoundCloud every Monday, and mine are available every Thursday. Click here to give us a listen.

Youre invited to visit my personal blog at http://www.themswire.com.

***

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.

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Stem cell agency indirectly boosted by national industry group – Capitol Weekly

Posted: January 18, 2020 at 7:50 pm

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by DAVID JENSEN posted 01.13.2020

One of the nations leading regenerative medicine industry groups is touting multi-billion dollar savings that may be achieved with the type of stem cell and gene therapies that are being developed with cash from Californias financially beleaguered stem cell program.

The industry group is the Washington, D.C-based Alliance for Regenerative Medicine (ARM). It is tackling one of the major issues facing development of commercial stem cell therapies sticker shock at their expected prices, running upwards of a $1 million or more.

The ARM study predicted cost savings of as much as $33.6 billion over about a decade in connection with three afflictions: sickle cell disease (SCD),multiple myeloma (MM) andhemophilia A (Hem A).

Without a willingness from health care insurers to cover the costs and provide a pathway to profit, it is unlikely that the biotech industry will embrace production of the therapies.

In a study released Friday, the group said:

Advances in molecular biology and genetics are leading to new treatments for rare diseases that require new ways of assessing value. CGTs (cell and gene therapies) are directed at the underlying cause of a condition and offer durable, potentially curative, or near-curative benefits. These transformative therapies create challenges for current reimbursement frameworks as they (the therapies) require significant upfront costs but are expected to provide a lifetime of benefits. The recurring treatment costs of chronically-managed patients can be greatly reduced and even eliminated with a one-time administration or short course of these novel therapies.

As CGTs arrive on the market, payers need new models for assessing their value. These treatments could potentially end the patients burden of illness, resulting in cost offsets (eliminating or reducing the need for long-term treatment, hospitalizations, and other care) and productivity gains that span a lifetime. Manufacturers incur a high per-patient development cost for these therapies and payers who bear the cost of treatment may not realize the long-term financial benefits due to health plan switching.

The ARM study predicted cost savings of as much as $33.6 billion over about a decade in connection with three afflictions: sickle cell disease (SCD), multiple myeloma (MM) and hemophilia A (Hem A).

The discussion of the costs of stem cell therapies has special resonance in the Golden State where voters are likely to be asked next fall to give $5.5 billion more to its stem cell agency.

Californias stem cell agency was not mentioned in the study, but it has funded research in all three areas. The agency is a member of ARM.

The study, backed by ARM and performed bythe Marwood Group, said, Access to CGTs for even a modest number of patients with MM, SCD, and Hem A each year can reduce overall disease costs by nearly 23% over a 10-year period. The savings from lowering healthcare costs and raising productivity are considerable, approaching $34 billion by 2029. Of the savings, $31 billion are from a reduction in healthcare costs and $3 billion are from productivity gains.

The model used by ARM assumed CGT prices as high as $2 million. The study said, The model has tested more than 180 different prices across the three potential CGTs that ranged from a minimum test price of $150,000 and up to a maximum price test of $2,000,000. The prices entered into the model created 60 different cost savings curves for all three of drugs in this model. Prices were distributed with more than 50% of test prices in the $100,000-$600,000 price per administration range.

The discussion of the costs of stem cell therapies has special resonance in the Golden State where voters are likely to be asked next fall to give $5.5 billion more to its stem cell agency, known formally as theCalifornia Institute for Regenerative Medicine (CIRM).

The agency, funded with $3 billion in 2004, is down to its last $27 million. A new, proposed ballot initiative is focusing hard on affordability of stem cell treatments. The initiative has no specific solutions but stipulates that a new version of CIRM if the ballot measure is approved should devise some ways to come up with answers for insurers who are not likely to warm easily to $1 million therapies.Eds Note: DavidJensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report, where this story first appeared. He has published more than 4,000 items on California stem cell matters in the past 15 years.

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Giraffe Will Go Through Risky Procedure At Cheyenne Mountain Zoo To Treat Ongoing Health Issues – CBS Denver

Posted: January 18, 2020 at 7:50 pm

COLORADO SPRINGS, Colo. (CBS4) A 16-year-old giraffe named Mahali will go through a risky procedure as animal care specialists work to treat some ongoing health issues. Animal care specialists say Mahali has arthritis and fractures in his feet, which hes recently indicated have become painful.

Zoo officials say theyve treated similar conditions before with special shoes and stem cell injections but Mahali has recently regressed in his training and isnt allowing them to attempt those treatments.

Weve exhausted all of our usual treatment options. This means we are now gearing up for an anesthetization to immobilize and treat Mahali, officials stated Wednesday.

The VP of Mission and Programs, Dr. Liza, and Giraffe Animal Care Manager, Jason, explained that giraffe anesthesia is risky but say it is in Mahalis best interest in this case.

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Muscular dystrophy collaboration aims to correct muscle stem cells’ DNA – Harvard Office of Technology Development

Posted: January 18, 2020 at 7:50 pm

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January 13, 2020

We expect that a satellite cell with the corrected DMD gene would quite quickly and continuously propagate the edited gene throughout the muscle tissue, said Prof. Amy Wagers, who leads the research. (Photo credit: Jon Chase/Harvard Staff Photographer.)

Cambridge, Mass. January 13, 2020 Harvard University stem cell researchers led by Amy Wagers, PhD, are embarking on a major study of Duchenne muscular dystrophy (DMD). Supported by research funding from Sarepta Therapeutics, under a multi-year collaboration agreement coordinated by Harvards Office of Technology Development (OTD), the project aims to use in-vivo genome editing, in mouse models of DMD, to fully and precisely restore the function of the dystrophin protein, which is crucial for proper muscular growth and development. Approaches validated by this work may point the way to an eventual therapeutic strategy to reverse DMD in humans.

Duchenne muscular dystrophy is a genetic disease caused by the lack of a protein called dystrophin that normally helps to support the structural integrity of muscle fibers, including those in the heart. Without the dystrophin protein, cells are weaker and degenerate more quickly. Over time, affected individuals boys, typically, as it is a recessive X-linked disorder lose their capacity to move independently.

Its really a devastating disease; it robs young boys of their capacity to be young boys, said Wagers, who is the Forst Family Professor of Stem Cell and Regenerative Biology, Co-Chair of the Department of Stem Cell & Regenerative Biology, and an Executive Committee Member of Harvard Stem Cell Institute. Though it is early days, Im hopeful that through this work we may identify and validate new avenues for therapy to completely rescue the proper expression and function of the dystrophin protein and regenerate healthy muscle tissue.

Researchers worldwide have pursued a variety of promising approaches such as cell and gene therapies, small-molecule therapies, and others to lessen or prevent the disease and improve patients quality of life.

The strategy pursued by the Wagers Lab at Harvard aims to fully correct the genetic template for dystrophin at its source, in the DNA of stem cells (satellite cells) that create and regenerate muscle cells. Combining cutting-edge CRISPR/Cas9 genome editing technologies with a deep knowledge of stem cell science and regenerative biology, this approach if successful might offer a permanent restoration of muscular function.

In skeletal muscle, muscle fibers are terminally post-mitotic, meaning they cannot divide and they cannot reproduce themselves, Wagers explains. If you lose muscle fibers, the only way to produce new muscle is from stem cells, specifically the satellite cells. The satellite cells are self-renewing, self-repairing, and ready to spring into action to create new muscle fibers. So we expect that a satellite cell with the corrected DMD gene would quite quickly and continuously propagate the edited gene throughout the muscle tissue.

At present, research conducted in mice has shown promising results. In June, the Wagers Lab published the results of editing stem cells in vivo, demonstrating that stem cell genes can be edited in living systems, not only in a dish. In that work, Wagers and her team delivered genome editing molecules to the cells using adeno-associated viruses (AAVs). Her lab has also successfully used gene editing in heart, muscle, and satellite cells to partially restore the function of the DMD gene that encodes dystrophin, by chopping out faulty sequences of code that are disrupting the proper reading frame.

The new stem-cell approach pursued in collaboration with Sarepta would build on these achievements and use more precise genome editing approaches, in animal models of DMD, to entirely replace genetic mutations in the DMD gene with correctly encoded sequences. The project will also explore alternate delivery methods and strategies to mitigate immune effects of in vivo genome editing.

This ambitious project will benefit greatly from the resources and insights of a company with deep clinical experience in the development of therapeutics for muscular dystrophy, said Vivian Berlin, Managing Director of Strategic Partnerships at Harvard OTD. Preclinical discoveries by Harvard researchers may open entirely new possibilities for lifesaving treatments in the long run, offering much-needed hope to patients and families in the future. Were grateful to be able to sustain the important momentum already established in Prof. Wagers lab, through this collaboration.

As we work to bring forward new treatments for patients with DMD, Sarepta is excited to support Prof. Wagers and her lab to accelerate the development of a gene editing approach, which has shown significant potential in early studies, said Louise Rodino-Klapac, Sareptas Senior Vice President of Gene Therapy. This multi-year collaboration is part of Sareptas broader commitment to pursuing all therapeutic modalities and advancing our scientific understanding of gene editing in order to maximize the potential of this approach to help patients.

Under the terms of the agreement between Harvard and Sarepta, the company will have the exclusive option to license any arising intellectual property for the purpose of developing products to prevent and treat human disease. As with any research agreement facilitated by OTD, the right of academic and other not-for-profit researchers to use the technology in further scholarly work is preserved.

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