StemCell Therapy

A multiple myeloma expert helps newly diagnosed patients understand the standard of care for their disease.

Richter, an assistant professor of medicine at the Tisch Cancer Institute at the Ichan School of Medicine in Mt. Sinai Hospital located in New York City, noted that there are always exceptions to this rule, but the standard of care is to keep patients with multiple myeloma to continue therapy long term.

This standard of care, however, presents unique challenges and questions for newly diagnosed patients about to undergo treatment. In an interview during the 2019 CURE Educated Patient Summit on Multiple Myeloma in Charlotte, North Carolina, Richter had the chance to address the key aspects of a multiple myeloma diagnosis and how he addresses common questions from patients.

CURE: What does transplant eligible and transplant ineligible mean for patients?

Richter: The notion of transparent eligibility in the U.S. is not clearly defined. One of the people who trained me used to say, Do the patients have the tiger? relating back to Rocky, and essentially what this means is people who are younger tend to be more eligible. So, are you able to undergo the intensive nature of that procedure and chemotherapy?

If you're younger and healthier, you're generally transplant eligible. As you get older, with more medical problems, it becomes more of a risk. Everything in medicine from a Tylenol to a transplant has a risk and benefit. If you are 105 years old and had a heart attack last week, you're not going to be eligible. If you're 40 and otherwise healthy, you're eligible and everywhere in between is an evaluation of risks and benefits.

How would you describe the standard of care for patients with multiple myeloma?

In general, the standard of care is to attempt to get people onto three drugs. The three drugs usually mean a steroid, and then either an immunomodulatory drug, a proteasome inhibitor or a monoclonal antibody, and using those different combinations to come up with two or three-drug combinations, and actually in some cases four-drug combinations.

The general discussion of which one makes sense is we generally try to put some on a three-drug combination and the two most common ones now VRd (Velcade, Revlimid, and dexamethasone) is really a very big standard approach. There's some really wonderful, emerging data from the MAIA study, looking at taking Revlimid and dexamethasone and adding Darzalex (daratumumab) as a three-drug regimen for people who are not going on to transplant and some of that data looks amazing.

But for the most part, the precision that we use has to do not so much with the tumor but with the patient. Meaning for some diseases, the precision in the upfront setting is we look at a genetic marker and we target that. But for myeloma our upfront choice of therapy is saying, what are your comorbidities? What are your risks? For someone who has neuropathy, we may avoid Velcade. Someone has heart issues, we may avoid carfilzomib (Kyprolis) and if someone has difficult coming back and forth for long infusions, we may avoid Darzalex. So, most of the precision that we use is custom tailoring it not necessarily to the disease upfront, although that's part of it, but also to the patient.

What is the role of stem cell transplantation in treating patients with multiple myeloma?

The role of transplant is constantly evolving in myeloma. A generation ago, when we didn't have very good drugs, transplant was clearly the best thing to do because we didn't have good medicines. Transplant was the only way to get deep and durable remissions. Nowadays that we have such better therapies and even better ones along the way, it's being called into question about how much do we still need transplant. And it's a case by case basis, some people still clearly benefit from transplant.

It's an important discussion to have with your provider. But the risks have been well established for many years and we know how to manage them very well. Although there are risks for it, they're generally consolidated into a couple weeks to a couple of months, as opposed to being on long term treatment that can have ongoing risk of side effects. So, yes, they may be higher, but it's usually for a self-contained amount of time.

It's still a very important tool in our armamentarium to treat patients. Now, that being said, the majority of patients in the United States do not receive autologous transplant, so only about 30% and part of the reason has to do with the age of patients. The average age of a myeloma patient in the U.S. is 69, and many people in their 70s and 80s have other medical problems that make them not eligible for transplant.

There are some socioeconomic reasons, as well as referral patterns and access to care. I live in New York City, you can throw a rock and hit a transplant center, but there are parts of the country where the closest transplant center is hours and hours and hours away. And if you are older, sick or don't have easy transportation, it may be more difficult. So, many people do not receive transplant. However, many people nowadays may not even need it because our drugs have gotten so much better.

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Understanding the Key Aspects of a Multiple Myeloma Diagnosis - Curetoday.com

Brain imaging of pathological tau-protein tangles reliably predicts the location of future brain atrophy in Alzheimers patients a year or more in advance, according to a new study by scientists at the UC San Francisco Memory and Aging Center. In contrast, the location of amyloid plaques, which have been the focus of Alzheimers research and drug development for decades, was found to be of little utility in predicting how damage would unfold as the disease progressed.

The results, published Jan. 1, 2020, in Science Translational Medicine, support researchers growing recognition that tau drives brain degeneration in Alzheimers disease more directly than amyloid protein, and at the same time demonstrates the potential of recently developed tau-based PET (positron emission tomography) brain imaging technology to accelerate Alzheimers clinical trials and improve individualized patient care.

The match between the spread of tau and what happened to the brain in the following year was really striking, said neurologist Gil Rabinovici, MD, the Edward Fein and Pearl Landrith Distinguished Professor in Memory and Aging and leader of the PET imaging program at the UCSF Memory and Aging Center. Tau PET imaging predicted not only how much atrophy we would see, but also where it would happen. These predictions were much more powerful than anything weve been able to do with other imaging tools, and add to evidence that tau is a major driver of the disease.

Alzheimers researchers have long debated the relative importance of amyloid plaques and tau tangles two kinds of misfolded protein clusters seen in postmortem studies of patients brains, both first identified by Alois Alzheimer in the early 20th century. For decades, the amyloid camp has dominated, leading to multiple high-profile efforts to slow Alzheimers with amyloid-targeting drugs, all with disappointing or mixed results.

Many researchers are now taking a second look at tau protein, once dismissed as simply a tombstone marking dying cells, and investigating whether tau may in fact be an important biological driver of the disease. In contrast to amyloid, which accumulates widely across the brain, sometimes even in people with no symptoms, autopsies of Alzheimers patients have revealed that tau is concentrated precisely where brain atrophy is most severe, and in locations that help explain differences in patients symptoms (in language-related areas vs. memory-related regions, for example).

No one doubts that amyloid plays a role in Alzheimers disease, but more and more tau findings are beginning to shift how people think about what is actually driving the disease, explained Renaud La Joie, PhD, a postdoctoral researcher in Rabinovicis In Vivo Molecular Neuroimaging Lab, and lead author of the new study. Still, just looking at postmortem brain tissue, it has been hard to prove that tau tangles cause brain degeneration and not the other way around. One of our groups key goals has been to develop non-invasive brain imaging tools that would let us see whether the location of tau buildup early in the disease predicts later brain degeneration.

Despite early misgivings that tau might be impossible to measure in the living brain, scientists recently developed an injectable molecule called flortaucipir currently under review by the FDA which binds to misfolded tau in the brain and emits a mild radioactive signal that can be picked up by PET scans.

Rabinovici and collaborator William Jagust, MD, of UC Berkeley and Lawrence Berkeley National Laboratory, have been among the first to adopt tau PET imaging to study the distribution of tau tangles in the normally aging brain and in a smaller cross-sectional study of Alzheimers patients. Their new study represents the first attempt to test whether tau levels in Alzheimers patients can predict future brain degeneration.

La Joie recruited 32 participants with early clinical stage Alzheimers disease through the UCSF Memory and Aging Center, all of whom received PET scans using two different tracers to measure levels of amyloid protein and tau protein in their brains. The participants also received MRI scans to measure their brains structural integrity, both at the start of the study, and again in follow-up visits one to two years later.

The researchers found that overall tau levels in participants brains at the start of the study predicted how much degeneration would occur by the time of their follow up visit (on average 15 months later). Moreover, local patterns of tau buildup predicted subsequent atrophy in the same locations with more than 40 percent accuracy. In contrast, baseline amyloid-PET scans correctly predicted only 3 percent of future brain degeneration.

Seeing that tau buildup predicts where degeneration will occur supports our hypothesis that tau is a key driver of neurodegeneration in Alzheimers disease, La Joie said.

Notably, PET scans revealed that younger study participants had higher overall levels of tau in their brains, as well as a stronger link between baseline tau and subsequent brain atrophy, compared to older participants. This suggests that other factors likely other abnormal proteins or vascular injuries may play a larger role in late-onset Alzheimers, the researchers say.

The results add to hopes that tau-targeting drugs currently under study at the UCSF Memory and Aging Center and elsewhere may provide clinical benefits to patients by blocking this key driver of neurodegeneration in the disease. At the same time, the ability to use tau PET to predict later brain degeneration could enable more personalized dementia care and speed ongoing clinical trials, the authors say.

One of the first things people want to know when they hear a diagnosis of Alzheimers disease is simply what the future holds for themselves or their loved ones. Will it be a long fading of memory, or a quick decline into dementia? How long will the patient be able to live independently? Will they lose the ability to speak or get around on their own? These are questions we cant currently answer, except in the most general terms, Rabinovici said. Now, for the first time, this tool could let us give patients a sense of what to expect by revealing the biological process underlying their disease.

Rabinovici and his team also anticipate that the ability to predict future brain atrophy based on tau PET imaging will allow Alzheimers clinical trials to quickly assess whether an experimental treatment can alter the specific trajectory predicted for an individual patient, which is currently impossible due to the wide variability in how the disease progresses from individual to individual. Such insights could make it possible to adjust dosage or switch to a different experimental compound if the first treatment is not affecting tau levels or altering a patients predicted trajectory of brain atrophy.

Tau PET could be an extremely valuable precision medicine tool for future clinical trials, Rabinovici said. The ability to sensitively track tau accumulation in living patients would for the first time let clinical researchers seek out treatments that can slow down or even prevent the specific pattern of brain atrophy predicted for each patient.

Authors: La Joie is corresponding author on the study; Rabinovici is senior author. Additional authors on the study are Adrienne V. Visani, Jesse A. Brown, Viktoriya Bourakova, Jungho Cha, Kiran Chaudhary, Lauren Edwards, Leonardo Iaccarino, Orit Lesman-Segev, Zachary Miller, David C. Perry, Julie Pham, Julio C. Rojas, Howard J. Rosen, William W. Seeley, Richard M. Tsai, and Bruce L. Miller, all of UCSF; Suzanne L. Baker, Mustafa Janabi, and James P. ONeil, of Lawrence Berkeley National Laboratory (LBNL); and Jagust, of LBNL and UC Berkeley.

Funding: The study was supported by the Alzheimers Association (AARF-16-443577), the National Institute on Aging (NIA) of the US National Institutes of Health (R01-AG045611, P50-AG023501, P01-AG19724), the Tau Consortium, and an Alzheimers Disease Research Center of California grant (04-33516) from the California Department of Health Services.

Disclosures: Rabinovici receives research support from Avid Radiopharmaceuticals, GE Healthcare, and Life Molecular Imaging, and has received consulting fees or speaking honoraria from Axon Neurosciences, Roche, Eisai, Genentech, Merck. La Joie reports no conflicts of interest. See study online for a full list of conflict of interest disclosures.

The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.UCSF Health, whichserves as UCSFs primary academic medical center, includestop-ranked specialty hospitalsandother clinical programs,and has affiliations throughout the Bay Area.

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Alzheimer 'Tau' Protein Far Surpasses Amyloid in Predicting Toll on Brain Tissue - UCSF News Services

National level developments

Malaysia Health Minister Datuk Seri Dr Dzulkefly Ahmad has said back in November 2018 that the Ministry of Health is committed to ensuring that the electronic medical record system (EMR) can be realised within three years at 145 hospitals nationwide. He estimated that it would cost up to RM1.5B to implement an EMR system for the 145 hospitals nationwide in Malaysia over the next five years, HealthcareIT News reported in July 2019. While there has been quite a lot of buzz about the nation-wide EMR implementation in the country, there seems to be a lack of concrete developments in the discussion and execution of the said EMR system, something that we hope to see more of in 2020.

Vietnam, on the other hand, has gone ahead and deployed their nationwide EHR in July last year, with 24 provinces implementing EHRs. Australias My Health Record (MHR) has a participation rate of 90% and the Australian Digital Health Agency (ADHA), which is in charge of MHR, has been working with software vendors to improve the functionality of the MHR.

At the HIMSS AsiaPac19 conference in October 2019, the HIMSS Thailand National Digital Healthcare Workforce Development Initiative (WDI) was officially launched. This Initiative sees the development of a three-year work plan to address the demand of patients for digital healthcare services in light of the Thailand 4.0 digitization journey, as well as healthcare tourism being one of the key economy drivers.

As part of the HIMSS Thailand National Digital Healthcare WDI, HIMSS also announced its intention to enter into a memorandum of understanding (MoU) with True Digital Group, a subsidiary of True Corporation, a leading communications conglomerate in Thailand, to create a HIMSS Digital Health Centre @ True Digital Park, which is slated to be launched in early 2020.

Singapores Deputy Prime Minister and Minister of Finance Heng Swee Kiat announced in November 2019 a national Artificial Intelligence (AI) strategy to transform Singapores economy and improve the lives of citizens. In terms of healthcare, the emphasis of the national AI strategy will be on chronic disease management and prevention. This includes the deployment of the Singapore Eye Lesion Analyzer, Selena+, a system which analyzes retinal photographs across the nation for diabetes screening by 2022.

Much ado about AI and its applications in healthcare

During the panel discussion on the current and future developments of AI at the HIMSS Singapore eHealth & Health 2.0 Summit in April 2019, Dr Ngiam Kee Yuan, GCTO, NUHS, observed that AI technologies in healthcare are slightly overhyped but in terms of real adoption, there needs to be factors like a really mature EHR system, good data streams, finding ways to deploy these AI technologies and training doctors to buy in into using these technologies. Simply put, good AI technology implementation in healthcare cannot just happen in a vacuum.

AI (in healthcare) needs to be human-centric and this sentiment is agreed upon by panelists at the Innofest Unbound conference in Singapore. A lot of radiologists are already using Computer Aided Diagnosis (CAD) for mammography and it has been happening for some time. So the idea is for us as a tech startup to pursue what we call human-centric AI. We try to make AI as explainable as possible and we always want humans to be involved in the whole process, said Dr Reid Lim, founder of MEDGIC, a startup which utilizes AI to detect skin conditions.

Cybersecurity risks still prevalent

Despite being more advanced than its neighbors in APAC, Singapore was hit by another healthcare cybersecurity incident in February 2019, which saw the leak of confidential information regarding 14,200 individuals diagnosed with HIV. Ransomware attacks hit hospitals and health services in Victoria, Australia in October 2019 and some facilities have had to revert to manual systems to maintain services.

Richard Staynings, Chief Security Strategist, Cylera said in an HealthcareIT News interview that healthcare compliance does not equal to security and the industry needs to adopt a risk-based approach to security based upon assets rather than controls.

2020 predictions?

The introduction of more user-friendly, less costly and accurate Internet of Medical Things (IoMT) devices, combined and complemented with advanced analytics, will take healthcare to the next level of value-driven care and personalized medicine, said Benedict Tan, Group Chief Digital Strategy Officer, SingHealth and Chairperson, Organizing Committee, HIMSS AsiaPac 20 Conference.

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HIT-related developments in APAC A 2019 Overview - Healthcare IT News

How does the brain work? What is the connection between its structure and its functioning? A team of Israeli scientists from the Technion Institute of Technology, in cooperation with colleagues from the US and France, has managed to demonstrate the significance of personalized brain models, which could have a meaningful impact in the field of personalized medicine.In an academic article published Thursday in PNAS, the official journal of the National Academy of Sciences of the United States, the group demonstrated that the individual map of structural neural connections, which are the physical links between regions, predicts the individual functional connectivity patterns, namely, how neural activity is spreading in the brain.As explained in a statement, the researchers took advantage of mice studies to "systematically investigate the informative content of different structural features in explaining the emergence of the functional ones."They employed structural magnetic resonance imaging (MRI) to scan mice's brains, then built a virtual model of their brain and tried to simulate their functional organization based on the structural connectivity, finally comparing it to the results of functional MRI on the same mice.With this study, the scientists were able to demonstrate that individual variations define a specific structural fingerprint with a direct impact upon the functional organization ofindividual brains. This finding will potentially support future clinical trials focusing on personalized treatments in brain disorders such as epilepsy, depression and Alzheimers disease, in which the virtual brain may predict treatment outcome in individual patients.The study was conducted by Professor Itamar Kahn, director of the Brain Systems Organization in Health and Disease Lab at Technion. Graduate students Eyal Bergmann and Francesca Melozzi were lead co-authors. Kahn's work focuses on investigating brain function and behavior in health and disease. As explained in the American Technion Society's website, his research has applications for neurodegenerative diseases such as Alzheimer's and Parkinson's and neurodevelopmental disorders including autism and attention deficit hyperactivity disorder.

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Israeli scientists shed new light on how the brain functions - The Jerusalem Post

What happened

Several top Canadian marijuana stocks soared by double-digit percentages on Tuesday. Shares of Aurora Cannabis (NYSE: ACB) were up by 12.3% as of 3:08 p.m. EST. Canopy Growth (NYSE: CGC) stock was jumping 12.1%. Tilray's (NASDAQ: TLRY) gain for the day was in the same ballpark, with shares up 12.5%. Aphria (NYSE: APHA) lagged behind slightly, with the stock rising 10.6%.

Two of the biggest winners, though, were Cronos Group (NASDAQ: CRON) and Sundial Growers (NASDAQ: SNDL), with shares vaulting 16.8% and 22.6% higher, respectively.

What lit a fire beneath these Canadian marijuana stocks on the last day of 2019? There wasn't any major news today. Probably the biggest factor behind today's spike is that the Cannabis 2.0 market for cannabis derivative products is picking up steam. Most of the stocks that jumped also have double-digit short percentages of shares outstanding, so any upward movement can result in short-sellers closing out their positions, contributing to even greater increases in share prices.

Image source: Getty Images.

All of the big marijuana stocks with big moves today have taken a shellacking in 2019, with the exception of Aphria, which fell only slightly during the year. The lack of an adequate retail infrastructure, particularly in Ontario, has presented a major obstacle for Canadian cannabis producers. However, the year is ending on a positive note; Ontario is taking steps to open more retail stores at the same time the Cannabis 2.0 market is shifting into gear.

There's a good reason for investors to be optimistic about the potential for these stocks in the Cannabis 2.0 market. Professional services organization Ernst & Young projects the market could reach close to 6 billion Canadian dollars by 2025.

It's still very early, though. Today's jump stems from anticipation and hopes, instead of hard sales numbers. Still, many investors could be justified in thinking that the 2019 sell-off for Canadian pot stocks could have been overdone, in light of the improving environment that should be on the way in 2020.

Watch for reports of how well sales in the Cannabis 2.0 market are going early in the new year. Aphria will be the first major Canadian cannabis producer to announce earnings results, on Jan. 14, 2020. Although those results are for the quarter ending in November and won't include any Cannabis 2.0 sales, the company's management could provide some insight into how the launch of its new products is going.

Here's The Marijuana Stock You've Been Waiting ForA little-known Canadian company just unlocked what some experts think could be the key to profiting off the coming marijuana boom.

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Cannabis legalization is sweeping over North America 11 states plus Washington, D.C., have all legalized recreational marijuana over the last few years, and full legalization came to Canada in October 2018.

And one under-the-radar Canadian company is poised to explode from this coming marijuana revolution.

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Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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Why Aurora Cannabis, Canopy Growth, and Other Top Canadian Marijuana Stocks Soared Today - Nasdaq

In 2020, AI could empower robotics with tools such as this Brain Bulder workspace. Source: Neurala

For the past decade, robotics has been one of the most interesting areas for developers, industry analysts, and startups to focus on. From emerging technologies and new applications to ongoing challenges, both innovators and entrepreneurs will have a lot to watch in 2020.

The Robot Report spoke with the following executives at robotics and artificial intelligence companies about their observations of 2019s trends, as well as their expectations for the new year:

Which technologies do you expect to mature the most in 2020, such as the Industrial Internet of Things (IIoT), edge computing, 5G wireless networks, or autonomous vehicles?

Visti: In 2020, Industry 4.0 will become more of a reality than a vision. Smart machines keep getting smarter as they get access to more data, and they keep getting better at connecting to other machines and systems, and therefore they become truly useful for manufacturers.

Thomas Visti, Mobile Industrial Robots

While many companies have been hesitant and seen Industry 4.0 as merely a buzzword, were starting to see connected supply chains where MES [manufacturing execution systems], robots, and picking systems are connected.

We also see the connectivity between robots and ERP [enterprise resource planning] systems within production environments.

The entire process from ordering to producing and then transporting goods can now be fully automated. Industry 4.0 is still evolving, and it will not reach its full potential in 2020, but we will see more companies adopting the enabling technologies. This will also influence the workforce, as we will see the same companies wanting to upskill their current workforce and recruit new employees with Industry 4.0 skills.

Versace: Well see more demand for AI that can be trained, deployed, and refined at the edge. 2019 has shown us that many organizations, robotics companies included, are saying No to giving up their data and having to ping the cloud.

I believe that in 2020, AI will need to live and learn at the edge, so that processing occurs where the data is being generated. As a result, robotics companies will see reduced latency problems while mitigating privacy issues and massive cloud fees for manufacturers.

Sudhir Jha, Brighterion

Jha:Enterprises will transition into deploying complex AI models in production at scale. So far, most AI applications are experiments but not in production, simple recommendation/prediction/regression models, or applied to smaller problems.

In 2020, we will see more enterprises getting bolder with their AI ambitions and requiring their vendors to support large deployments.

There will be be an acceleration from automation to autonomy, and AI will play the most crucial role in this. Also, robotics will move further from industrial arena to consumer arena, where they will act as personal coaches, instructors for children, conversational buddies for elders, and guides for the disabled.

Which market or application represents the biggest area of growth potential in 2020?

Visti: We expect to see an increase in the use of robotics in all our existing markets such as automotive, electronics, FMCG [fast-moving consumer goods], pharmaceuticals, and more.

There is still a huge focus on optimization, and with the lack of qualified workers, the need for automation across industries has never been higher.

We expect big growth in the use of AMRs by the 3PL [third-party logistics] segment, which has not been an early adopter of AMRs. In fact, our recent survey showed that only around 50% of 3PLs are currently considering automating internal logistics with AMRs. We expect to see this figure increase significantly in 2020 and the years ahead.

The hospital sector is also looking to automate internal transportation worldwide. For MiR, we have many customers within this segment in Scandinavia and China, but we expect it to grow even more.

Jha: Verticals like healthcare will see expanded AI-based applications, not only in the areas of diagnosis and personalized medicine, but also on the operational side like customer service, payment processing, and FWA (fraud, waste, and abuse).

How will trade conflicts or the slowdown in automotive manufacturing affect robotics in 2020?

Visti: While the automotive manufacturing market may have slowed, the latest statistics from the Robotic Industries Association actually shows what looks like an uptick in ordering of industrial robots by automotive OEMs, up 47% for 2019 over 2018.

Were also experiencing increased growth in that market and overall, with companies like Toyota and Ford purchasing fleets of our AMRs.

We expect this is due to these manufacturers realizing how automation can help fill difficult-to-fill jobs; increase overall productivity; and enable humans to focus on higher-skilled, higher-quality, and higher-paid tasks. These are all benefits that can lead to growth and new job opportunities, which could help turn the automotive industry back around.

Versace: We will always be faced with some degree of socioeconomic uncertainty around the world. In terms of manufacturing, possible decoupling of Chinese and Western economies may actually bolster manufacturing in the U.S. and make it less reliant on overseas production in the long run. This may indirectly boost robotic deployments in the U.S. and Europe.

But at Neurala, were focused on what we can control, which is first and foremost to provide robotics and other companies with an AI platform that they can apply to solve real-world challenges. Our Brain Builder platform is helping organizations accelerate the process of building, deploying, and analyzing AI so they can focus on improving visual inspections.

Related content: Industry experts provide more robotics predictions for 2020

What challenges and opportunities do you expect for AI in 2020?

Jha: As AI-based solutions become more mainstream across industries, we need to carve out a handful domain where our technology provides sustainable differentiation and allows us to be a leader.

We have focused on risk and compliance areas in financial services and are looking to diversify in other verticals. Also our strength in building mission-critical applications in highly regulated industries will serve us well to ensure data privacy and ethical use of AI which is a growing trend globally.

Max Versace, Neurala

Versace: Im thinking of 2020 as the Year of Productization and the Customer.

At Neurala, well continue to work with customers so that they can independently build and deploy custom AI applications for the real world.

Furthermore, AI products such as Brain Builder will enable customers with little or no expertise in AI to build an end-to-end application from scratch, on their proprietary data. This means that enterprises will no longer be restricted by their size or resources when it comes to implementing AI as a part of their business strategies.

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In 2020, AI to enable acceleration from automation to autonomy, say experts - Robot Report

According to the latest study conducted byMarket Growth Analysisthe global market for precision medicine is anticipate grow manifold, reflecting a robust CAGR of over XX% during 2018 to 2025.

Rapid augmentation of the medicine industry across the globe will certainly benefit the global market for precision medicine. In addition, factors such as growing infrastructural development, higher investments, streamlined drug approval systems along with companion diagnostics are expected to favor the overall market growth during the assessment period. Cost-effective DNA profiling and increasing prevalence of carcinogenic diseases worldwide are additional factors that are projected to propel the market growth. Moreover, apt storage of genome data is of great significance to the global market for precision medicine as demand for data medicare is on the rise. However, acute data storage capacity, data privacy breach and discrepancies in funding systems and hefty price tag of personalized drugs may deter the market growth in the near future.

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The global market for precision medicine has been categorized into various parent segments that are further segmented into smaller sub-divisions.

On the basis of technology, next-gen sequencing, bioinformatics and drug discovery technology are expected to be the technologies highlighting the expanding the market width in forthcoming years. Based on applications, the oncology segment is expected to witness an overwhelming growth and is estimated to reach US$ XX Billion over 2025, reflecting a staggering XX% CAGR. This is primarily owing to increasing prevalence of tumor-related disease amongst the global geriatric population. On the other hand, increasing cases of arthritis will favor the growth of immunology segment, which is expected to surpass US$ XX Million in revenues by 2025 end.

Vendor News

Key players operating in the global market for precision medicine include Eli Lilly And Company, Novartis AG, AstraZeneca and Laboratory Corporation of America Holdings. Most of the companies are implementing market strategies involving mergers, tie-ups and acquisitions. Increasing collaboration between healthcare and IT is expected to deliver fruitful gains to the market, expanding the overall business canvas for the stakeholders in the upcoming years.

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The popularity of precision medicine has grown significantly across various parts of the world, hence on the basis of region, the markets for precision medicine in Asia Pacific, North America, Europe, Latin America, and the Middle East and Africa (MEA) is set to achieve new figures of growth over the next eight years. Precisely, the market in North America is expected to present new lucrative opportunities, occupying over XX% share of the market during the forecast period. In addition, the region is estimated to surpass a market valuation of over US$ XX Million by the end of 2025.

The US and Canada will be the heavyweights of the global market owing to the existence of well-established medical industries in both the countries. In Europe, the market is expected to witness a steady growth and will increase its revenues charts close to US$ XX Million, riding on a healthy CAGR of over XX% during the assessment period. This is largely due to the increasing demand for precision medicines in countries such as France, UK, Italy and Germany. The Asia Pacific region is another region which is considered to be full of business potentials. The region is projected to increase at over XX% CAGR to reach approximately US$ XX Million by 2025 end. The market in APAC will be heavily dominated by Japan, while, India and China will compete for the second spot. Likewise, the in Latin America the market is expected to surge at a pace in terms of revenue over 2025. However, MEA will witness a sluggish growth of the market which is attributed to the lack of initiatives for conductive extensive research and development activities.

Browse more detail information about this report visit at: http://marketgrowthanalysis.com/precision-medicine-market

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Precision Medicine Market to Restrict Revenue Growth During the Forecast Period 2025 Bulletin Line - Bulletin Line

Patients with multiple myeloma have a lot to look forward to in the treatment space thanks to precision medicine, but one treatment option alone will not cure the disease.

At the 2019 CURE Educated PatientSummit on Myeloma in Charlotte, North Carolina, Rodriguez, director of the myeloma and plasma cell disorder program at Wake Forest University, had the chance to speak to numerous patients with multiple myeloma on the current treatment landscape of the disease and precision medicines role in it.

This year, Rodriguez also participated in the Multiple Myeloma Research Foundations Moving Mountains for Multiple Myeloma program when he took a 10-day journey through the South American region of Patagonia with other multiple myeloma survivors and specialists. This journey allowed Rodriguez to have intimate contact with patients who have multiple myeloma and talk with them about the future of treatment for the disease.

In an interview with CURE, Rodriguez explained the role of precision medicine in the treatment of patients with multiple myeloma and how he addresses common questions about it from patients.

CURE: How has precision medicine changed the landscape of treatment for patients with multiple myeloma?

Rodriguez: Precision medicine has changed the way we treat myeloma in many ways, and that not only means that we are finding new therapy that can target specific areas of the cancer cells, (allowing us) to have more effective therapy with less side effects, but it also means that we can actually tailor therapy to an individual patient.

It's not just that we're developing new drugs that are homing in on the cancer cells, but it also is that we're taking some time to individualize the care based on each patient's needs, each patient's requirements, and the cancer that each patient has. We do know that multiple myeloma is not a one-stop, everybody-has-the-same-type disease; everybody has different variants, and within a person, there's different subgroups of myeloma cells that needs to be targeted in a different way.

What are some of the questions about precision medicine that patients might have for you, and how do you address them?

One of the questions that normally arises whenever precision medicine, or personalized medicine, or targeted therapy all of these words are used interchangeably in clinic (comes up) is: Will a new treatment that targets a specific mutation cure my disease, if I have that mutation? And that's a very valid question, because you would think that if we've designed a therapy that can target a particular mutation that your cancer has, that we would eradicate the cancer.

Yet, the reality is, I don't think that targeting one particular mutation is going to be the solution to our problems. Myeloma is composed of many subgroups of myeloma cells within one patient.

So, combining precision medicine with a therapy that we already have and targeted immunotherapy that might give us a broader aspect of how we can target the cancer and have better control of it. Hopefully, by combining different targeted therapies with standard therapy, we might be able to eradicate the cancer. But the precision medicine or a single agent on its own is probably not going to be the solution for it.

What are some of the unique challenges from the use of precision medicine to treat patients with multiple myeloma?

One of the challenges of precision medicine in myeloma in particular is that myeloma tends to evolve as time goes by, and it's developing new mutations. And these new mutations can cause resistance to therapy. Even if we're using precision medicine that can target a particular mutation, if that cancer cell continues to evolve and mutate, maybe that particular mutation, or that target, might change as well, and then the therapy stops working.

That's a big challenge that we still have with precision medicine, that we need to figure out how we can factor that in whenever we're treating patients. So, resistance to therapy, despite (the use) of precision medicine, is something that we can potentially see.

What is the difference between DNA and RNA testing for patients with multiple myeloma?

The difference between DNA and RNA when it comes to cancer is a little bit different. We're using genes now to understand how cancer behaves. That's given us a lot of information about how we can potentially treat myeloma and how it normally behaves. A lot of doctors might say, Oh, I'm checking your DNA, or I'm checking your RNA to see what information we can get from it.

The main difference is, DNA is all the genes that we have in our body, and all the genes that are going to be in a cell and particular in a cancer cell. RNA are the genes that are actually used and expressed in those cancer cells. So not all the DNA is used. It's just the RNA portion that's going to be telling us what sections of the DNA are actually active and which ones are not.

Can you discuss some of the highlights from your keynote lecture at the 2019 CURE Educated Patient Summit on Multiple Myeloma?

The focus of the talk was on a few factors. One is that we've realized that treating myeloma patients it's not the same if I treat somebody here or if I treat somebody in a different state or in a different country. Humans are not all the same. We all are very unique. We all have very different characteristics and features, medical problems, social issues, environmental differences and walks of life. We cannot use one same treatment for all of us, because it's not going to be effective for all of us.

So, tailoring it for our different characteristics is one part of precision medicine. And then the other factor in my talk was the cancer itself. Myeloma is not just one cell type, where all the people who have myeloma are going to have the same characteristics. It's very variable, and within patients, there's variability, and there are different clones of myeloma cells in that same patient, and then each patient is very different in terms of how their myeloma is.

We've learned so much about cancer, and myeloma in particular, that we've now been able to identify different subgroups of myeloma cells within a patient, or between patients, that we can target and be more specific in how we treat. So, the goal of the talk was to let everybody see that whenever we are treating myeloma, we have to individualize the care to that particular patient.

More:
Precision Medicine Paves the Way for Exciting Treatment Combinations for Patients with Multiple Myeloma - Curetoday.com

As 2019 comes to a close, this is the perfect time to consider what lies ahead in the new year. As a physician working in digital health, my sense is that the pace of change in medicine is accelerating in ways that we havent seen before.

Here are my picks for the top healthcare trends to watch in 2020:

1. Tech giants will build more tools to support doctors.Apple, Amazon and other tech giants have been increasing their focus on consumer healthcare products for several years now, from the Apple Watch to Alexas voice-enabled prescription refills. In 2020, expect to see these companies increase their attention on the physician community.

Top health industry issues of 2020: Will digital start to show an ROI?

Each year, PwC's Health Research Institute (HRI) names the top issues for the health industry in the coming year. What made the list for 2020? Join HRI for a discussion of the most important trends for providers, insurers, pharma/life sciences and employers.

Google is determined to fix the mediocre choices among existing electronic health records (EHRs) with its own integrated charting system. They plan to leverage their dominance in Search to make it easier for doctors to find data across multiple systems with a single login. In addition, their smart compose technology will help clinicians enter information accurately, with typos becoming a thing of the past. Users will also be able to search scanned documents, such as faxes, handwritten and typed notes.

The optimist in me hopes that all EHR companieswill see Googles entry as a nudge to be more physician- and patient-friendly, enabling doctors to spend less time staring at computer screens and more time making eye contact with patients.

2. Personalized medicine will become even more precise.The past decade showed us that a one-size-fits-all approach to medicine is under attack. While customized medical therapies are not yet available on a wide-scale, we are on the path to making substantial life-saving strides soon. The capability to leverage a person's distinct genetic make-up to provide them with tailored therapies will continue to be refined in 2020 and beyond. This should give physicians more treatment options and possibly help patients diagnosed with serious conditions to live longer, fuller lives.

3. Telemedicine will continue its growth streak.Research reveals that patient demand for telehealth is growing fast. According to a study published inJAMA, telemedicine visits grew 261% between 2015 and 2017.And physicians are enthusiastically supporting this trend.

At Doximity, we saw the number of doctors that self-reported practicing telemedicinedouble in just three years between 2015 and 2018.At the same time, the government is recognizing the benefits of telemedicine.AnExecutive Ordersigned this year outlined Medicare reform intended to help speed telemedicine adoption.Additionally, theU.S. Department of Veterans Affairswill focus efforts on telemedicine to benefit veterans in need of care.

Technological advancements, an aging population, and personalized medicine will all have an impact on the future of healthcare. The next decade will certainly introduce the healthcare industry to new challengesand from those challenges solutions for providers and patients will emerge.

Peter Alperin, M.D., is vice president at Doximity, an online networking service for medical professionals.

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Industry VoicesA doctor's perspective on the top 3 healthcare trends to watch in 2020 - FierceHealthcare

A breast cancer drug that can provide a last resort option to patients who have run out of treatments has been granted accelerated approval from the Food and Drug Administration, a move that could provide a new standard of care for hundreds of thousands of women with the disease.

The drug, called Enhertu, was recently granted approval for patients who have received two or more prior treatments for inoperable or metastatic HER2-positive breast cancer, a type of cancer that learns to resist the drugs designed to attack it.

The drug is given intravenously and will be available by prescription in the United States in the coming weeks. The drug can offer less severe side effects than chemotherapy for some patients.

Its always really hard to know the options are getting thinner. Theres a lot we can do for HER2-positive breast cancer, though we do reach a time where there is little else we have to offer and I think having a drug like this provides a lot of hope, said Dr. Eric Winer, director of the breast cancer program at Dana-Farber Cancer Institute.

Cheryl Osimo, executive director of the Massachusetts Breast Cancer Coalition, was diagnosed with stage two HER2-positive breast cancer in 1991 and was given a poor prognosis.

It was a life-changing experience for me in more ways than one, Osimo said. Her cancer did not resist treatment, and six months of chemotherapy along with six weeks of radiation proved successful in beating the deadly disease.

Im one of the lucky ones, there are many women who are not so lucky, so those who have to move on to try other treatments, to learn there are options where there are less painful side effects is good news, said Osimo.

About one in five breast cancers are HER2-positive. The drug works by attaching chemotherapy to antibodies that offer a targeted attack on the cancer cells.

Dr. Michael Misialek, associate chair of pathology at Newton-Wellesley Hospital, said Enhertu offers a new standard of care for patients running out of alternatives.

It gives patients another option, it gives oncologists another arrow in their tool kit to fight the cancer and the big picture here is that treatment of breast cancer is following the pathway more and more of personalized medicine, said Misialek, who is also the medical adviser to the Massachusetts Breast Cancer Coalition.

Winer also noted a shift in cancer care with the approval of groundbreaking drugs like Enhertu, saying, I can imagine a time when we wont be giving standard chemotherapy.

Winer said new treatments are giving patients hope, This is an example of the fact that if they just hang in there and manage to do well for however long they can with the drug they have, there may be something else coming around the corner.

Read the original:
FDA approval of new breast cancer drug offers hope to patients with few options - Boston Herald

AGOURA HILLS, Calif., Dec. 27, 2019 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQB:MATN) today announced the publication of a peer-reviewed research article co-authored by Fatih Uckun MD. PhD, the Chief Medical Officer for Mateon, Vuong Trieu, PhD, the Chief Executive Officer and President for Mateon and four hematology/oncology professors from academic US institutions in the prestigious oncology journal Cancers (Basel).

The article describes in detail the data obtained in the recently completed multi-institutional OXI1222 study that was aimed to evaluate the clinical potential of Mateons lead anti-leukemia drug Combretastatin A1 (also known as OXi4503) in adult patients with previously treated relapsed acute myeloid leukemia (AML). This clinical study was registered at http://www.clinicaltrials.gov as NCT02576301. Patients were treated by participating leukemia experts affiliated with the University of Florida, University of Kansas Cancer Center, David Geffen School of Medicine at UCLA, and University of Miami Sylvester Comprehensive Cancer Center, Miami who co-authored the published article. The primary purpose of this Phase 1B study was to define the maximum tolerated dose and safety profile of OXi4503 and cytarabine administered in combination (OXA) in patients with relapsed/refractory AML. The study was completed in August 2019 and met its primary endpoint. The study showed that adding OXi4503 to the standard chemotherapy drug cytarabine was generally well tolerated by AML patients and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination. In 26 evaluable AML patients, there were 4 complete remissions (CR/CRi) and one partial remission (PR). The CR responses were associated with >1-year overall survival times. The combination therapy exhibited a manageable toxicity and a promising benefit to risk profile in older adults with relapsed AML who are in urgent need for effective new therapies. The safety, feasibility, and early clinical activity of this new treatment in relapsed/refractory AML deserves further clinical validation in a randomized registration study.

This work emphasizes our commitment to find effective new therapies for difficult-to-treat cancers,stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OXi4503 has received orphan drug designation for AML in both the US and the European Union. Further, the US FDA has granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML.

AML is the most common form of adult acute leukemia with >20,000 estimated new cases and >10,000 deaths in the United States (US) for 2019. Despite recent advances in therapy, the five-year overall survival remains < 30% and prognosis is grim in patients who experience a recurrence of their disease after first-line induction therapy, with <10% surviving five years after relapse.The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen.By combining OXi4503 with the standard chemotherapy drug cytarabine, we hope to develop an innovative approach that improves outcomes for patients with relapsed AML, especially those who are older and have a dismal prognosis, explained Fatih Uckun, MD, PhD, Chief Medical Officer of Mateon Therapeutics.

The research article "A Phase 1B Clinical Study of Combretastatin A1 Diphosphate (OXi4503) and Cytarabine (ARA-C) in Combination(OXA) for Patients with Relapsed or Refractory Acute Myeloid Leukemia" hasbeen published in Cancers (Basel) as part of the Special Issue Personalized Medicine:Recent Progress in Cancer Therapy and is available online:

Abstract:https://www.mdpi.com/2072-6694/12/1/74PDF Version:https://www.mdpi.com/2072-6694/12/1/74/pdfSpecial Issue:https://www.mdpi.com/journal/cancers/special_issues/PM_Cancers

About Mateon TherapeuticsMateon was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB:MATN) creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer. The founding team members of Oncotelic were responsible for the development of Celgenes Abraxane as a chemotherapeutic agent for breast, lung, melanoma, and pancreatic cancer. Abraxane was approved in 2005 and has more than $1B in sales annually. The same team was also responsible for the development of Cynviloq, a next generation Abraxane, which was acquired by NantPharma for $1.3B. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on pediatric cancer patients. For more information, please visit http://www.oncotelic.com and http://www.mateon.com.

The Chief Executive Officer of Mateon, Dr. Vuong Trieu, PhD is a very experienced biotech executive and a KOL in the field of immunotherapy. He is best known for his seminal contributions to the development of Abraxane (https://www.linkedin.com/in/vuong-trieu-3a64aa3b).

The Chief Medical Officer of Mateon, Dr. Fatih Uckun MD, PhD, is an internationally renowned KOL in cancer research and treatment (https://www.linkedin.com/in/fatihuckun). Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous national and international awards for his work on biologics and small molecule targeted therapeutics for difficult-to-treat cancers. He is a former recipient of the Stohlman Memorial Award from the Leukemia & Lymphoma Society, the highest honor given to a Clinical Leukemia Scholar.

Mateon's Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as may, expect, anticipate hope, vision, optimism, design, exciting, innovative, promising, will, conviction, "estimate," "intend," "believe", quest for a cure of cancer, innovation-driven, paradigm-shift, high scientific merit, impact potential and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the companys product candidates and the potential use of the companys product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the companys annual report on Form 10-K filed with the SEC on April 10, 2019 and in the companys other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.

Contact Information:For Mateon Therapeutics, Inc.:Amit ShahEmail: ashah@oncotelic.com

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Mateon Therapeutics Team Publishes a New Peer-Reviewed Oncology Article on the Positive Clinical Study Results for Its Lead Anti-Leukemia Drug...

As we close out this decade, our biggest medtech stories of the past year have all looked toward whats coming nextwhether its new treatments or renewed companies, the common thread running through our most popular reads is that people are eager to see these advancements realize their promise.

Our top 10plus some honorable mentionsinclude research and breakthroughs in diabetes, Alzheimers disease, cancer testing and vision care, with some products tantalizingly close to that FDA green light and getting into the hands of doctors and patients.

It also covers large devicemakers and big pharmas aiming to remake themselves by embracing new technology or potentially new acquisitions.

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

Up first is our report on a closed-loop artificial pancreas system being developed by Tandem Diabetes Care and Dexcom that promises to automatically deliver insulin based on continuous glucose data and eliminate the need for frequent fingerstick draws or daily injections for people who have Type 1 diabetes.

A six-month trial supported by the National Institutes of Health followed participants as young as 14 as they used the system over their daily lives and found it helped keep blood sugar in a healthy range for longer. More importantly, users saw fewer spikes and drops over a 24-hour periodimportant news for children and adults who would prefer to sleep than manage their diabetes. The Control-IQ system recently picked up its FDA approval.

In an interesting twist, another of our most read stories also featured an artificial pancreas system, though it first debuted in 2016. Making its viral return this year was our piece on the FDAs approval of Medtronics MiniMed 670G, designed to regulate insulin with little personal input.

Our second story of 2019 comes from the annual meeting of the American Society of Clinical Oncology, where blood testing upstart Grail delivered early study results for its cancer-seeking diagnostic. Its liquid biopsy was able to identify 12 early-stage cancers and their locations in the body by searching for small, tainted pieces of tumor DNA floating in the bloodstream.

In third place is Novartis new, expansive partnership with Microsoft, which aims to put artificial intelligence tools in the hands of each of the big pharmas research associates. The five-year project includes plans for joint AI labs and clinical research supportand is paired with our tenth most popular story of the year, on the drugmakers separate team-up with Amazon to help revamp its supply chain and personalized medicine manufacturing.

Next, we have startup Sigrid Therapeutics, developer of an edible medical device to help ward off the progression of Type 2 diabetes. Technically a therapeutic material, Sigrid has been working on a superfine silica powder that mechanically separates stomach enzymes from food to slow down digestive processes.

In fifth is Strykers $4 billion acquisition of Wright Medical, which looks to give the company a stronger foothold in fast-growing orthopedic markets focused on the upper and lower extremitiesincluding joint replacements, bone grafts and fixation systems for shoulders, elbows, wrists, ankles and toes.

Elsewhere, Apple, Eli Lilly and Evidation presented their first results from a collaboration that hopes to develop digital warning signs for Alzheimer's by sifting through the data and patterns created in our day-to-day lives. Their work, on trying to spot the nearly imperceptible symptoms and changes that could belie cognitive decline, was featured in our list of the top lighthouse projects in AI and biopharma to keep an eye on in the future.

In seventh and eighth place we have two pieces exploring the latest in contact lens technology. A new silicone hydrogel material from Alcon contains 51% water and holds a permanent layer of moisture on the surface of the daily disposable. A second lens, developed by CooperVision, is designed to help slow the progression of nearsightedness in children by splitting off incoming light and reducing a potential driver of myopia.

Number nine delves into the future of the $8 billion diagnostics maker Qiagen as it considers being acquired by one of several potential suitors. That includes fellow diagnostics maker Thermo Fisher Scientific, which has begun early talks, according to reports. The news comes just a month after Qiagen announced its long-time CEO plans to step down amid a reorganization of the company around a 15-year partnership with Illumina.

Finally, we have our annual class of the FierceMedTech Fierce 15, the private companies we think will best move the needle when it comes to patient outcomes and technological advancement in the field.

And on a broader note, wed like to thank you all for helping to make 2019 FierceMedTechs best year yetreadership has grown by leaps and bounds over the past 12 months, and by at least 1 million views over 2018s total. But that wouldnt be possible if we didnt cover a dynamic industry with a surplus of interesting stories to tell.

Though were taking a short publication break for the holidays, we, like you, are still looking forward to 2020 and the decade ahead. Check in for any breaking news, and feel free to share your tips, thoughts and stories with us. We will return Jan. 2. Conor Hale

Read your top 10 stories here:

1) Closed-loop artificial pancreas from Tandem, Dexcom aces Type 1 diabetes study

2) ASCO: In early study results, Grail's blood test identifies 12 cancers before they spread

3) Novartis to put AI on every employee's desk through Microsoft partnership

4) Sigrid Therapeutics aims to ward off Type 2 diabetes with an edible, powdered medical device

5) Stryker to buy orthopedic device maker Wright Medical for $4B

6) Apple, Eli Lilly and Evidation present first results from digital Alzheimer's study

7) Alcon to launch new water-containing silicone hydrogel contact lenses in the U.S.

8) FDA approves first contact lens to slow childhood nearsightedness

9) Thermo Fisher looks to buy fellow diagnostics maker Qiagen: Bloomberg

10) Novartis' digital transformation continues apace with Amazon supply chain tie-up

Link:
FierceMedTech's top 10 stories of 2019: Looking toward a new decade on the cutting edge - FierceBiotech

All too often, software patents stop more innovation than they promote. Patents are legal instruments that can be used to sue people and companies for creating, selling, or using software. Very often, the entities wielding software patents are patent trollscompanies that make money off suing and threatening to sue others instead of building or doing anything of their own.

Weve been advocating against problematic patents, particularly in software, for many years. In the past few years, its fair to say that patent trolls have been downbut not out. Two big changes that happened several years ago have made it realistic, finally, to get bad patents kicked out of the system. The first is the creation of the inter partes review system, in 2012; and next, the Supreme Courts Alice v. CLS Bank decision, in 2014.

Unfortunately, 2019 has shown us that we need to keep working to protect the patent system. Congress and the U.S. Patent Office have been working remarkably hard to roll back these positive changes, and make life easier for patent trolls. At the same time, the Federal Circuit has been eroding the effect of Alice in decisions like last years in HP v. Berkheimer and this years Garmin v. Cellspin.

At the beginning of the year, USPTO Director Andre Iancu promulgated new guidance for patent examiners that essentially allows them to blow off the clear guidelines of the Alice decision. What that meant, in practice, is that examiners are being told to issue more of the worst type of software patentsones that simply take abstract ideas, and make them sound like an invention by adding generic computer language. That means more patents coming out that will be fodder for patent trolls.

At EFF, we encouraged people to let the Patent Office know that the new guidelines were a bad idea. While we werent able to stop the new guidelines from taking effect, our supporters sent more than 1,500 comments to the Patent Officesending a strong message that everyday users of technology are finally watching a government office that, all too often, is left in a state of total industry capture.

In the U.S. Senate, leaders of a newly reconstituted IP Subcommittee have pushed forward two ideas that threaten to bring back the bad old days of peak patent trolling. The first attempt to empower patent trolls is a year-long effort to undermine Section 101 of the patent laws. Thats the section that bans patents on abstract ideas, natural phenomenon, and laws of nature. Its the area of law that the Supreme Court properly interpreted in the Alice case, and in recent years, has allowed courts to throw hundreds of junk patents out of the system.

Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) have insisted that Section 101 has stopped good inventions from getting patents. Thats not true. Many of the parties asking Congress to alter Section 101 are flat-out patent trolling entities, who dont invent any technology themselvestheyre simply good at manipulating the patent system and threatening lawsuits. Others are large incumbent companies with massive patent portfolios, like GlaxoSmithKline, Qualcomm, and IBM. These companies simply want more monopolies on areas of emerging technology, like artificial intelligence and personalized medicine.

At EFF, we spoke out against this misguided effort, and EFF Staff Attorney Alex Moss testified in front of Congress. In the end, no bill to damage Section 101 has yet been introduced. Thats a testament to the advocacy of EFF and our many allies on this issue. But well have to stay vigilant on this front, since theres no doubt the same groups, seeking to wring more money from the patent system, will be back again in 2020. Fortunately, were able to work together with a huge range of alliesnot just tech companies that want a balanced patent system, but also health care providers, labor unions, and consumer organizations.

Another perennial bad idea that returned in 2019 was the Stronger Patents Act, which would do a great job of strengthening patent trolls but offers nothing to true innovators. The Stronger Patents Act would have essentially wrecked inter partes review, or IPR, which is one of the most effective ways of challenging patents. Were glad to report this bill went nowhere, and hope we dont see it again.

Patent trolls continue to seek unjustified payments from companies of all sorts, many of them small firms that cant afford the million-dollar legal bills that would come with a patent trial. Just one example: a patent troll called Inventergy sued a family-owned GPS tracking company, along with several other GPS firms. Inventergy backed off once we sent a letter explaining the problems with its patent, and EasyTracGPS has become one of the firms that was Saved by Alice.

Another great example is Ruth Taylor, who was sued over her website that organized online photography contests. We helped Ruth win her patent case back in 2015. This year, we published a video interview with Ruth talking about her experience, facing down a patent trolls demand for $50,000 over her hobby website.

EFF scored a big win for transparency in the patent system when we intervened in a lawsuit filed by Uniloc, one of the most litigious patent trolls of all time, in court. Uniloc has sued dozens of technology companies, but at the same time has kept much of its most important pleadings redacted. But when Uniloc sued Apple, documents emerged that seemed to indicate Uniloc may not have rights to the patent it was asserting, because it had split the rights with a murky patent investment fund. EFF intervened to demand that the redacted documents be published, so that the public can understand the nature of Unilocs far-ranging allegations.

In May, Uniloc definitively lost this attempt to hide its machinations and shell games from the public. Uniloc has chosen to appeal this case to the Federal Circuit, where well defend the publics First Amendment right of access to the courts.

Finally, 2019 saw a major win for patents and free speech. In New Hampshire, a patent troll called Automated Transactions, LLC sued more than a dozen people and a trade group claiming it was defamedsimply because these groups had described it as a patent troll. EFF filed an amicus brief arguing this term cant be defamatory. The New Hampshire Supreme Court agreed, finding that calling someone a patent troll is a statement of protected opinion, not fact.

In 2020, with our supporters help, well continue to litigate, and advocate, for a fairer and more balanced patent system. And, when we need to, well call a troll a trolland you can, too.

This article is part of our Year in Review series. Read other articles about the fight for digital rights in 2019.

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Time to Save Alice: 2019 Year in Review - EFF

December 12, 2019 -Payers are using coordinated care and precision medicine to make diagnoses more quickly and ensure a strong treatment plan for severe and chronic disease management.

Early detection of chronic and severe diseases can mean the difference between life and death. It can also mean the difference between affordable therapies and crippling medical bills.

A March 2018 study found that early cancer diagnosis could result in significant cost savings nationally. Researchers looked at 17 types of cancer and estimated that early detection could save, conservatively, $26 billion nationally.

Recognizing what is at stake, payers take different approaches to catching severe or chronic illnesses in their formative stages.

Coordinated care is a simple, well-tested method for both chronic disease prevention and chronic disease management.

READ MORE: Chronic Disease Coordinated Care May Not Impact Pediatric Spending

Humana recently announced that it would pursue a traditional approach to ensure that patients in danger of chronic kidney and end of life renal disease find out early and get the support they need.

Humana will task skilled provider teams with catching these diseases earlier and implementing personalized treatments.

This coordinated care strategy builds a team of nephrologists, nurses, dietitians, and social workers from one of Humanas two partnerseither Monogram Health or Somatus, depending on geographic location.

The providers will work with the patients primary care physician to determine the best treatments and provide home healthcare options, patient education, and mental healthcare support through counseling.

This multidisciplinary approach will focus on detecting kidney disease earlier, slowing disease progression, and utilizing therapies that enable members to receive care in the convenience of their own home, said William Shrank, MD, MPHS, Humanas chief medical and corporate affairs officer.

READ MORE: Cigna and MSK Start Value-Based, Coordinated Cancer Care Program

Through this collaboration, we will strengthen care coordination for Humana members with kidney disease. Our partnerships will offer customized care options, and will empower patients with education and engagement tools to better manage their condition.

In February, Humana took a similar approach with its oncology program, enhancing its coordinated care strategy and using analytics to ensure quality care.

With new advancements every day in genetic therapies, precision medicine is another method payers use to ensure that patients receive a quick diagnosis and the best treatment plan.

CVS Health launched an oncology care program called Transform Oncology Care, which uses precision medicine to identify and treat cancer patients. The program is rolling out to Aetna members in 12 states but is also available for use by other payers.

Due to CVS Healths geographic and data footprint, it can assess the likelihood that a patient will get cancer. With that information, the patients provider can intervene early on to pursue preventive care, screenings, or therapies.

READ MORE: Precision Medicine Challenges Persist, Aetna Leads Response

When it comes to identifying the appropriate therapies, the program allows providers to use genetics to identify the best course of treatment for a patient recently diagnosed with cancer.

Timing in cancer care is everything and when a patient does not get started on the right treatment it can result in progression and higher costs, said Alan Lotvin, MD, executive vice president and chief transformation officer at CVS Health.

We are the first company working to make the latest in precision medicine accessible to more patients and further empower informed treatment decision-making based on a patient's genetic profile to give them the best chance for successful treatment and improved quality-of-life.

Working in coordination with its third-party vendor, Tempus, CVS Healths new program will enable patients to undergo a broad-panel gene sequencing test once diagnosed to determine the best treatment. This is ideal not only for patients in early stages of cancer, but especially for patients in more advanced stages who need to start treatment as soon as possible.

Because genomic sequencing has certain eligibility requirements, providers are not always aware that gene sequencing is an option open to their patient.

In order to ensure that oncologists prescribe gene sequencing to eligible patients, CVS Health introduced a web-based provider portal into its e-prescribing software which allows oncologists to see the patients eligibility for the broad-panel gene sequencing tests among other functions.

For those who qualify, the program identifies the best treatment options based on genetic makeup. It also alerts providers to potential clinical trials that patients can enroll in and makes the enrollment process easier and faster.

The program integrates National Comprehensive Cancer Network guidelines which are constantly updated for the most recent suggested prescribing and treatment options.

Critically, this service can be employed at the point of detection, so treatments can be identified immediately, and a therapeutic strategy quickly determined.

CVS Health combines this digital solution with a nurse-led coordinated care team to continue quality of care after the diagnosis.

This service is available for only fully insured commercial members.

Among its other chronic disease management developments, earlier this year, CVS Health used preventive care to improve diabetes treatment.

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Care Coordination and Precision Medicine Improve Early Diagnoses - HealthPayerIntelligence.com

BOSTON, Dec. 11, 2019 /PRNewswire/ --Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF), today announced positive, initial ex-vivo results of PTI's proprietary cystic fibrosis transmembrane conductance regulator (CFTR) modulators, PTI-801, PTI-808, and PTI-428, in individuals with CF who are ineligible for the current standard of care CFTR modulator therapies due to their genotype. The data are part of a pan-European strategic initiative, known as HIT-CF (Human Individualized Therapy of CF), which seeks to accelerate the development of, and access to, personalized therapies for CF patients, beginning with those for whom no currently approved CFTR modulator therapy is indicated.

HIT-CF is sponsored by the European Commission Horizon 2020 program, in which CF-Europe, a patient organization representing more than 48,000 individuals with CF, collaborates and with the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN), which is recruiting adult CF patients into the ex- vivo study through its 43 clinical trial centers. HIT-CF collects tissue samples from CF patients and develops organoids, or miniaturized organs, that are genetically identical to the patient donor, and share the same micro-anatomy as the organ from which they were derived.

As of today, rectal organoids from over 300 subjects have been collected for functional profiling and of those, 65 have been tested for response to PTI's investigational drugs. Early results support the initiation of enrollment of responding subjects into HIT-CF's clinical trial known as "CHOICES" (Crossover trial based on Human Organoid Individual response in CF - Efficacy Study), which is designed to evaluate the translation of organoid ex-vivo response to potential clinical benefit, such as changes in FEV1 and sweat chloride. CHOICES, which is expected to initiate in mid-2020, will be the first ever personalized medicine-based study in CF, with initial data expected by the end of 2020. Fully funded by the HIT-CF, this trial is a placebo controlled, double blind, crossover study with an 8-week treatment period and 6 months of uninterrupted dosing. The results may serve as the basis for a potential Marketing Authorization Application with the European Medicines Agency (EMA) in 2021 through a novel regulatory pathway which is being pursued jointly by Proteostasis and HIT-CF. The CHOICES clinical study is part of PTI's broader clinical development strategy for its CFTR modulator candidates that is already separately funded for the common genotypes.

Results from the HIT-CF project to date will be presented at the Keystone Symposia on Tissue Organoids titled "Tissue Organoids as Models of Host Physiology and Pathophysiology of Disease (J1)" taking place on January 19-23, 2020 in Vancouver, BC, Canada.

"Proteostasis is honored to have been invited to participate in the HIT-CF project and is the only company in the group with a combination of novel CFTR modulators being tested ex-vivo. We are very enthusiastic about the progress of the study," said Geoffrey Gilmartin, M.D., M.M.Sc., Chief Medical Officer of Proteostasis Therapeutics. "In Europe alone, there are more than 2,300 adult patients whose genotypes render them ineligible for approved CFTR modulators and exclude them from participating in clinical trials with this drug class. This project's proposed personalized medicine approach is paving a potential new way to develop and provide access to novel CFTR modulators for patients with the most dire need for treatment options that target the cause of the disease. Additionally, based on an individual patient's disease phenotype and not just the genetic designation, this approach could also create a new path towards more effective treatment for all people with CF."

"The inequality in access to CFTR modulators is an acute problem across Europe where 1 in 5 individuals do not have a F508del mutation. In addition, drug reimbursement policies are leading to an ever-growing gap between patients who do, and those who do not have effective treatment options," said Christiane De Boeck, Work Package Leader at HIT-CF, and Former President of ECFS. "At HIT-CF Europe, we believe that novel strategies such as personalized medicine and development of new treatment options are central to addressing the inequality of access across the continent. We are thrilled with these initial results and look forward to providing additional updates."

About Organoids

Organoids are cell cultures that grow in a culture dish and look similar to the organ from which they are derived. Because organoids are made from stem cells, they contain the same mutations as the person from whom the biopsies are derived. Investigational drugs which target the basic defect of CF can be used in an organoid system to evaluate rare mutations where the drugs may have a positive effect.

Unlike in vitro systems such as human bronchial epithelial (HBE) cells, which are derived from lungs that have been removed from CF patients, or the engineered, rat-derived FRT cell line, the latter has resulted in false positive clinical results, rectal organoids are cultured from tissues obtained through a minimally invasive and painless procedure from donors who then become eligible to participate in a clinical study. Organoids can provide valuable insights for donors, including their likelihood of achieving improvements in pulmonary function and reductions in sweat chloride concentration with CFTR modulators based on the ex-vivo response to those drugs.1

About HIT-CF Europe

HIT-CF Europe is a research project which aims to provide better treatment and better lives for people with cystic fibrosis (CF) and rare mutations. To achieve this, drug candidates are first tested on patient-derived organoids in qualified laboratories across Europe. Subsequently, based on the measured signal in the organoids, a smaller group of patients will be invited to participate in a clinical trial with one or more investigational molecules from a participating pharmaceutical company.

All participating centers are part of the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN). The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement number 755021. For more information, visit http://www.hitcf.org.

About Proteostasis Therapeutics, Inc.

Proteostasis Therapeutics, Inc. is a clinical stage biopharmaceutical company developing small molecule therapeutics to treat cystic fibrosis and other diseases caused by dysfunctional protein processing. Headquartered in Boston, MA, the Proteostasis Therapeutics team focuses on identifying therapies that restore protein function. For more information, visit http://www.proteostasis.com.

Safe Harbor

To the extent that statements in this release are not historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "aim," "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements made in this release include, without limitation, statements regarding the expected presentation at an upcoming conference. Forward-looking statements made in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Such risks and uncertainties include, without limitation, our expectations regarding our participation in HIT-CF's pan-European strategic initiative,the potential of our proprietary combination therapies for the treatment of CF, the potential benefit of our proprietary combination therapies to patients, expected timing of patient enrollment in, data from, the completion of, and reporting top line results of our clinical studies and cohorts for our clinical programs, including our planned Phase 2 program and initiation of a pivotal or registrational study, the possibility final or future results from our drug candidate trials (including, without limitation, longer duration studies) do not achieve positive results or are materially and negatively different from or not indicative of the preliminary results reported by the Company (noting that these results are based on a small number of patients and small data set), uncertainties inherent in the execution and completion of clinical trials (including, without limitation, the possibility that FDA or other regulatory agency comments delay, change or do not permit trial commencement, or intended label, or the FDA or other regulatory agency requires us to run cohorts sequentially or conduct additional cohorts or pre-clinical or clinical studies), in the enrollment of CF patients in our clinical trials in a competitive clinical environment, in the timing of availability of trial data, in the results of the clinical trials, in possible adverse events from our trials, in the actions of regulatory agencies, in the endorsement, if any, by therapeutic development arms of CF patient advocacy groups (and the maintenance thereof), in the commercialization and acceptance of new therapies, and those set forth in our Annual Report on Form 10-K for the year ended December 31, 2018, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and our other SEC filings. We assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACTS:

Investors: David Pitts / Claudia StyslingerArgot Partners212.600.1902 david@argotpartners.com/ claudia@argotpartners.com

Media:David RosenArgot Partners212.600.1902david.rosen@argotpartners.com

1Berkers et al, Rectal Organoids Enable Personalized Treatment of Cystic Fibrosis Cell Reports 26, 17011708,February 12, 2019

SOURCE Proteostasis Therapeutics, Inc.

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Proteostasis Therapeutics to Initiate First Ever Personalized Medicine-Based Clinical Trial, CHOICES, in European CF Patients with Genotypes...

December 12, 2019 -Seventy-three percent of precision medicine adopters say these initiatives have neared or exceeded their expectations, with organizations using clinical analytics solutions and real-world data to meet their goals, according to a global survey from XIFIN and the Journal of Precision Medicine.

Approximately 59 percent of participants said that their EHR, EMR, or similar solutions did not meet or only partially met the needs of hands-on precision medicine users, indicating that success will require more advanced tools.

The fundamental design of EHRs makes them unsuitable for precision medicine programs because detailed patient data, such as biomarkers, are locked within a PDF, explained Nigel Russell, editor-in-chief of theJournal of Precision Medicine.

Physicians need real-time access to the patient data that will enable them to make the best patient care decisions, and today, investors and providers alike are looking for technologies that provide comprehensive clinical, diagnostic and financial data to ensure and build successful PMI programs.

The survey polled a total of 189 respondents, 62 percent of whom were from the US. The seniority of participants ranged from faculty or departments heads to board members and C-level executives.

Respondents said they are currently using provider-facing clinical analytics solutions, real-world data aggregation technology, business intelligence tools, and clinical data warehouse to advance their precision medicine initiatives, and that their frequency of use is higher than expected.

Just over ten percent of participants said they are currently using real-world data for disease insights or cohort studies, while just over nine percent are using real-world data to inform either clinical trial matching or peer-reviewed publications.

Eleven percent of respondents said that within two years, real-world data will be used for converge decision making. Just over nine percent said that real-world data will be used for drug efficacy and safety within two years, and the same percentage said real-world information will be used for clinical utility evidence development over the next two years.

Within three to five years, 12.4 percent of respondents believe that real-world data will be used for regulatory submissions, while just over ten percent think real-world data will inform claims adjudication or expansion of drug indications.

While precision medicine is becoming more mainstream, it is still a nascent discipline. Sharing the details of initiatives across the healthcare community will serve to accelerate adoption and determine future best practices so that we can truly harness precision medicine informatics for better outcomes, said Lle White, CEO, XIFIN.

For instance, the survey results demonstrate early adopters are already thinking about how high- quality real-world data will support and potentially accelerate clinical utility evidence development, coverage decision making, claims adjudication, expansion of drug indications, and regulatory submissions.

Powerful information like this is essential to reducing the cost of healthcare and improving patient outcomes, White added. It is imperative that organizations have a real-world data strategy both from a real-time access standpoint as well as from an actionable analytical insights perspective.

Precision medicine initiatives were also found to have a positive impact on certain quality metrics. Approximately 74 percent of respondents said precision medicine initiatives are increasing organizations ability to access real-world data. Almost 65 percent noted that precision medicine is improving organizations ability to query this data.

Additionally, 76.7 percent of healthcare professionals said precision medicine initiatives are having a positive impact on patient outcomes, while 53.3 percent said these initiatives are boosting patient satisfaction.

Over 76 percent said that precision medicine projects were helping care teams make better decisions, and 58.8 percent said precision medicine is increasing care teams ability to deliver personalized care. Nearly 56 percent said these initiatives are helping provide clinical decision support to care teams.

These findings indicate that with advanced technologies and comprehensive data, precision medicine could help health systems achieve their care goals. Going forward, if health systems adopt the right tools and develop effective solutions, precision medicine initiatives may become a larger part of the healthcare landscape, enabling organizations to deliver more informed, quality care.

Precision medicine and population health informatics offer the potential to infuse data at its most basic unit, the report concluded.

In addition, they put accompanying insights from aggregated de-identified data into precision medicine practitioners hands via the software that they use every day to support the decisions they need to make as part of the patient care journey.

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Over 70% of Orgs Say Precision Medicine Meets or Tops Expectations - HealthITAnalytics.com

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Genetics just got personal. So boasted the website of 23andMe in 2008, just after launching its DNA testing service.

As we entered this decade, a small cohort of companies 23andMe, its Silicon Valley neighbor Navigenics, and Icelandic competitor deCODE Genetics were selling a future of personalized medicine: Patients would hold the keys to longer and healthier lives by understanding the risks written into their DNA and working with their doctors to reduce them.

We all carry this information, and if we bring it together and democratize it, we could really change health care, 23andMe cofounder Anne Wojcicki told Time magazine when it dubbed the companys DNA test 2008s invention of the year, beating out Elon Musks Tesla Roadster.

But in reality, the 2010s would be when genetics got social. As the decade comes to a close, few of us have discussed our genes with our doctors, but millions of us have uploaded our DNA profiles to online databases to fill in the details of our family trees, explore our ethnic roots, and find people who share overlapping sequences of DNA.

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Its become like Facebook for genes, driven by the same fundamental human desire to connect. And, as with Mark Zuckerbergs social media behemoth, this is the decade we reckoned with what it really means to hand over some of our most personal data in the process.

A 23andMe saliva collection kit for DNA testing.

It all panned out differently from the way I imagined in 2009, when I paid $985 to deCODE and $399 to 23andMe to put my DNA into the service of science journalism. (I spared my then-employer, New Scientist magazine, the $2,500 charge for the boutique service offered by Navigenics.)

I was intrigued by the potential of DNA testing for personalized medicine, but from the beginning, I was also concerned about privacy. I imagined a future in which people could steal our medical secrets by testing the DNA we leave lying around on discarded tissues and coffee cups. In 2009, a colleague and I showed that all it took to hack my genome in this way was a credit card, a private email account, a mailing address, and DNA testing companies willing to do business without asking questions.

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Much of the rest of what I wrote about DNA testing back then reflected pushback from leading geneticists who argued that the companies visions of personalized medicine werent ready for primetime.

As I explored the reports offered by 23andMe and deCODE, I couldnt help but agree especially when deCODE wrongly concluded that I carry two copies of a variant of a gene that would give me a 40% lifetime chance of developing Alzheimers. (Luckily, it wasnt cause for panic. Id pored over my DNA in enough detail by then to know that I carry only one copy, giving me a still-elevated but much less scary lifetime risk of about 13%.)

Despite such glitches, it still seemed that medicine was where the payoffs of mainstream genetic testing were going to be. As costs to sequence the entire genome plummeted, I expected gene-testing firms to switch from using gene chips that scan hundreds of thousands of genetic markers to new sequencing technology that would allow them to record all 3 billion letters of our DNA.

So in 2012, eager to provide our readers with a preview of what was to come, New Scientist paid $999 for me to have my exome sequenced in a pilot project offered by 23andMe. This is the 1.5% of the genome that is read to make proteins and is where the variants that affect our health are most likely to lurk.

Experts at the Medical College of Wisconsin in Milwaukee analyzed my exome. While they werent at that point able to tell me much of medical significance that I didnt already know, the article I wrote from the experience in 2013 predicted a future in which doctors would routinely scour their patients genomes for potential health problems and prescribe drugs that have been specifically designed to correct the biochemical pathways concerned.

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Im glad I included an important caveat: This may take several decades.

By then, the revolution promised by 23andMe and its competitors was faltering. Navigenics and deCODE had both been acquired by bigger companies and stopped selling DNA tests directly to the public.

23andMe, backed by the deep pockets of Google and other Silicon Valley investors, had enough cash to continue. But it fell foul of the FDA, which had decided that the company was selling medical devices that needed official approval to be put on the market. In a 2013 warning letter, the FDA said that 23andMe had failed to provide adequate evidence that its tests produced accurate results. By the end of 2013, 23andMe had stopped offering assessments of health risks to new customers.

Since then, the company has slowly clawed its way back into the business of health. In 2015, it was given FDA approval to tell customers whether they were carriers for a number of inherited diseases; in 2017, it started providing new customers with assessments of health risks once more.

I recently updated my 23andMe account, getting tested on the latest version of its chip. My results included reports on my genetic risk of experiencing 13 medical conditions. Back in 2013, there were more than 100 such reports, plus assessments of my likely responses to a couple dozen drugs.

In the lab, discovery has continued at a pace, but relatively few findings have found their way into the clinic.

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If youve recently been pregnant, you were probably offered blood tests to tell whether your fetus had a serious genetic abnormality. And if youve been diagnosed with cancer, a biopsy may have been sequenced to look for mutations that make some drugs a good bet and other ones a bust. Neither would have been common a decade ago.

But the wider health care revolution envisaged by Wojcicki remains far off.

A few weeks ago, I saw my doctor to discuss my moderately high blood cholesterol and had a conversation that Id once predicted would be common by now. I had signed up for a project called MyGeneRank, which took my 23andMe data and calculated my genetic risk of experiencing coronary artery disease based on 57 genetic markers, identified in a 2015 study involving more than 180,000 people.

My genetic risk turns out to be fairly low. After I pulled out my phone and showed my doctor the app detailing my results, we decided to hold off on taking a statin for now, while I make an effort to improve my diet and exercise more. But it was clear from her reaction that patients dont usually show up wanting to talk about their DNA.

We have all these naysayers and an immense body of research that is not being used to help patients, said Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California, which runs the MyGeneRank project.

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Joseph James DeAngelo, the suspected "Golden State Killer," appears in court for his arraignment in Sacramento, April 27, 2018.

23andMes collision with the FDA wound up being a turning point in ways I didnt anticipate at the time. From the start, the company included an assessment of customers ancestries as part of the package. But after the FDA cracked down, it pivoted to make ancestry and finding genetic relatives its main focus. Offering the test at just $99, 23andMe went on a marketing blitz to expand its customer base competing with a new rival.

Ancestry.com launched its genome-scanning service in May 2012 and has since gone head-to-head with 23andMe through dueling TV ads and Black Friday discount deals.

DNA tests became an affordable stocking filler, as millions of customers were sold a journey of self-discovery and human connection. We were introduced to new genetic relatives. And we were told that the results might make us want to trade in our lederhosen for a kilt or connect us to distant African ancestors.

Today, Ancestrys database contains some 15 million DNA profiles; 23andMes more than 10 million. Family Tree DNA and MyHeritage, the two other main players, have about 3.5 million DNA profiles between them. And for the most dedicated family history enthusiasts, there is GEDmatch, where customers can upload DNA profiles from any of the main testing companies and look for potential relatives. It contains about 1.2 million DNA profiles.

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So far, so much fun. But DNA testing can reveal uncomfortable truths, too. Families have been torn apart by the discovery that the man they call Dad is not the biological father of his children. Home DNA tests can also be used to show that a relative is a rapist or a killer.

That possibility burst into the public consciousness in April 2018, with the arrest of Joseph James DeAngelo, alleged to be the Golden State Killer responsible for at least 13 killings and more than 50 rapes in the 1970s and 1980s. DeAngelo was finally tracked down after DNA left at the scene of a 1980 double murder was matched to people in GEDmatch who were the killer's third or fourth cousins. Through months of painstaking work, investigators working with the genealogist Barbara Rae-Venter built family trees that converged on DeAngelo.

Genealogists had long realized that databases like GEDmatch could be used in this way, but had been wary of working with law enforcement fearing that DNA test customers would object to the idea of cops searching their DNA profiles and rummaging around in their family trees.

But the Golden State Killers crimes were so heinous that the anticipated backlash initially failed to materialize. Indeed, a May 2018 survey of more than 1,500 US adults found that 80% backed police using public genealogy databases to solve violent crimes.

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I was very surprised with the Golden State Killer case how positive the reaction was across the board, CeCe Moore, a genealogist known for her appearances on TV, told BuzzFeed News a couple of months after DeAngelos arrest.

The new science of forensic genetic genealogy quickly became a burgeoning business, as a company in Virginia called Parabon NanoLabs, which already had access to more than 100 crime scene samples through its efforts to produce facial reconstructions from DNA, teamed up with Moore to work cold cases through genealogy.

Before long, Parabon and Moore were identifying suspected killers and rapists at the rate of about one a week. Intrigued, my editor and I decided to see how easy it would be to identify 10 BuzzFeed employees from their DNA profiles, mimicking Parabons methods. In the end, I found four through matches to their relatives DNA profiles and another two thanks to their distinctive ancestry. It was clear that genetic genealogy was already a powerful investigative tool and would only get more so as DNA databases continued to grow.

A backlash did come, however, after two developments revealed by BuzzFeed News in 2019. In January, Family Tree DNA disclosed that it had allowed the FBI to search its database for partial matches to crime-scene samples since the previous fall without telling its customers. I feel they have violated my trust, Leah Larkin, a genetic genealogist based in Livermore, California, told BuzzFeed News at the time.

Then, in May, BuzzFeed News reported that police in Centerville, Utah, had convinced Curtis Rogers, a retired Florida businessperson who cofounded GEDmatch, to breach the sites own terms and conditions, which were supposed to restrict law enforcement use to investigations of homicides or sexual assaults. That allowed Parabon to use matches in the database to identify the perpetrator of a violent assault.

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Larkin and other genealogists condemned the move, calling it the start of a slippery slope that would see the method being used to investigate more trivial crimes.

As barbs flew between genealogists working with law enforcement and those who advocate for genetic privacy, GEDmatch responded with new terms of service that extended the definition of violent crime, but also required users to explicitly opt in for their DNA profiles to be included in law enforcement searches.

Overnight, GEDmatch became useless for criminal investigations. Since then, the number of users opting in for matching to crime-scene samples has slowly increased, and now stands at more than 200,000. But progress in cracking criminal cases has remained slow.

Now that cops have seen the power of forensic genetic genealogy, however, they dont want to let it go. In November, the New York Times revealed that a detective in Florida had obtained a warrant to search the entirety of GEDmatch, regardless of opt-ins. It seems only a matter of time before someone tries to serve a warrant to search the huge databases of 23andMe or Ancestry, which dont give cops access sparking legal battles that could go all the way to the Supreme Court.

Genetic privacy, barely mentioned as millions of us signed up to connect with family across the world and dig into our ancestral roots, is suddenly front and center.

This week, Rogers and the other cofounder of GEDmatch, John Olson, removed themselves from the heat when they sold GEDmatch to Verogen, a company in San Diego that makes equipment to sequence crime-scene DNA. Verogen CEO Brett Williams told BuzzFeed News that he sees a business opportunity in charging police for access to the database but promised to respect users privacy. Were not going to force people to opt in, he said.

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But it isnt just whether cops can run searches against your DNA. 23andMe may not share your information with law enforcement, but customers are asked when they signed up whether if they are OK with their de-identified DNA being used for genetic research.

It might not be obvious when you fill in the consent form, but this lies at the heart of 23andMes business model. The reason the company pushed so hard to expand its database of DNA profiles is to use this data in research to develop new drugs, either by itself or by striking deals with pharmaceutical companies.

Ancestry has also asked its users to consent to participate in research, teaming up with partners that have included Calico, a Google spinoff researching ways to extend human lifespan.

You might be comfortable with all of this. You might not. You should definitely think about it because when the information is your own DNA, there really is no such thing as de-identified data.

That DNA profile is inextricably tied to your identity. It might be stripped of your name and decoupled from the credit card you used to pay for the test. But as 23andMe warns in its privacy policy: In the event of a data breach it is possible that your data could be associated with your identity, which could be used against your interests.

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And because you share a large part of your genome with close relatives, when you put your DNA profile into a companys database, you arent only making a decision for yourself: Their privacy is on the line, too.

Whether its due to concerns about privacy, a saturated market, or just that the novelty has worn off, sales of DNA ancestry tests are slowing. Ancestry has responded by offering a new product focused on health risks. Unlike 23andMe, it requires that tests are ordered through PWNHealth, a national network of doctors and genetic counselors.

Will this be the development that takes us back to the future I once imagined? Maybe so, but if the roller coaster of the past decade has taught me anything, its to be wary about making any predictions about our genetic future.

Peter Aldhous is a Science Reporter for BuzzFeed News and is based in San Francisco.

Contact Peter Aldhous at peter.aldhous@buzzfeed.com.

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10 Years Ago, DNA Tests Were The Future Of Medicine. Now Theyre A Social Network And A Data Privacy Mess. - BuzzFeed News

Three investigative therapies by Proteostasis Therapeutics PTI-801, PTI-808, and PTI-428 showed potential to treat cystic fibrosis (CF) patients ineligible for approved CFTR modulators after patient-specific lab models produced promising results that support a future clinical trial.

Funded by the EUs initiative HIT-CF (Human Individualized Therapy of CF), this early study was conducted on patient organoids, which are miniaturized organ models derived from patient cells.

Based on the positive results, a clinical trial in adult CF patients is expected to start in 2020. If successful, the trial results may serve as the basis for a marketing authorization applicationin Europe in 2021.

With the help of CF-Europe (a patient organization) and the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN), HIT-CF has been recruiting adult CF patients to collect tissue samples and create organoids, three-dimensional organ models grown in the lab.

Organoids mimic several characteristics of the organ from which they are derived, and are genetically identical to the donor. As such, they allow researchers to study biological processes and response to treatments in an environment that closely resembles human organs. As organoids are basically human cells cultured outside the body, they are said to be ex-vivo models.

The idea is to screen treatment candidates in the lab using intestinal organoids, or mini-intestines, obtained from rectal tissue (biopsies) of patients, which are collected through a quick and painless procedure. Then, based on how the organoids respond to each therapeutic candidate, a group of patients will be selected to enroll in a clinical trial.

Because the organoids can help determine the therapeutic candidate most likely to give the best results, researchers can personalize treatments for each patient before starting the trial.

So far, intestinal organoids from more than 300 patients have been created, of which 65 have been used to test Proteostasis potential CFTR modulators.

Proteostasis is honored to have been invited to participate in the HIT-CF project, and is the only company in the group with a combination of novel CFTR modulators being testedex-vivo. We are very enthusiastic about the progress of the study, Geoffrey Gilmartin, MD, chief medical officer of Proteostasis, said in a press release.

The positive results obtained on organoids support the launch of a clinical trial called CHOICES Crossover trial based on HumanOrganoidIndividual response inCF EfficacyStudy that will test the potential treatments on patients whose organoids responded favorably to the agents.

The study will also evaluate if organoids are good models to identify promising CF therapies, that is, if the responses measured on organoids translate to potential clinical benefits in patients, as reflected by lung function tests (FEV1) or sweat tests.

CHOICES will be a placebo-controlled, double-blind study that includes an eight-week treatment period, plus six months of constant dosing.

The study includes Proteostasis three candidate CFTR modulators, specially intended for patients who carry rarer CFTR genetic defects. All three compounds have different modes of action. PTI-801 works as a CFTR corrector, PTI-808 is a CFTR potentiator, and PTI-428 is a CFTR amplifier.

The trial is planned to start in mid-2020, with its first data anticipated for the end of 2020.

If moving forward, CHOICES will become the first trial based on personalized medicine for CF patients.

The inequality in access to CFTR modulators is an acute problem across Europe where 1 in 5 individuals do not have a F508del mutation [the most common CF-causing mutation]. In addition, drug reimbursement policies are leading to an ever-growing gap between patients who do, and those who do not have effective treatment options, said Christiane De Boeck, Work Package Leader at HIT-CF.

At HIT-CF Europe, we believe that novel strategies such as personalized medicine and development of new treatment options are central to addressing the inequality of access across the continent. We are thrilled with these initial results and look forward to providing additional updates, De Boeck added.

Gilmartin said that in Europe more than 2,300 adult CF patients are ineligible for approved CFTR modulators, and therefore excluded from participating in clinical trials.

This projects proposed personalized medicine approach is paving a potential new way to develop and provide access to novel CFTR modulators for patients with the most dire need for treatment options that target the cause of the disease. Additionally, based on an individual patients disease phenotype, and not just the genetic designation, this approach could also create a new path towards more effective treatment for all people with CF, Gilmartin said.

Proteostasis is also running a clinical trial evaluating a combination of the three candidate therapies for the treatment of CF patients who have at least one copy of the F508del mutation in the CFTR gene.

Ana is a molecular biologist enthusiastic about innovation and communication. In her role as a science writer she wishes to bring the advances in medical science and technology closer to the public, particularly to those most in need of them. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she focused her research on molecular biology, epigenetics and infectious diseases.

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Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Personalized CF Medicine to be Tested for Rare Genetic Defects in Europe - Cystic Fibrosis News Today

Artificial Intelligence has come a long way since it was in its blooming stages in the 1940s. It was a time when the direct interaction between AI and humans seemed impossible and people were even scared by the thought. All sorts of theories started emerging that made artificial intelligence look deadly for humans. The idea of robots or droids were thought of as something that could hurt the human population and even drive them to extinction. In spite of all theories, researchers were able to predict one thing for sure. Artificial intelligence will be able to transform lives and the way humans interact with one another. It will reshape the societies and industries that we know today.

Welcome to 2019, an era where artificial intelligence is vividly present all around us. In other words, we are living in the age of AI. Take a look around you. Be it the smart assistant on our mobile phones, websites, e-commerce platforms, search engine results, home automation appliances, classrooms, and more. Every single element is trying to adopt AI and cause an impact for the good. This is in turn radically transformssocieties and pushespeople to develop emotional bonding with their gadgets and AI devices. Today, when we want to find directions to a place, we do not stop by strangers and ask them. Instead, we turn on Google maps and let technology guide us.

One of the biggest breakthroughs in artificial intelligence has been its implementation in the healthcare sector. One of the most fundamental industries in the world, the healthcare sector is far behind in todays world. Even though technological marvels are constantly fascinating in the world, there is a significant amount of work that needs to be done in the healthcare sector. From diagnosis to medicine and providing healthcare facilities in rural areas, artificial intelligence has a lot of scope for health care support.

However, there has been some significant progress in the healthcare industry. All thanks to artificial intelligence that was powered by the wave of digitization. As more and more organizations are turning digital, its providing an abundance of data for machines to work upon them. Now we have robots that are successfully performing surgery on patients, software programs that are better diagnosing diseases far better than traditional pathological practices, and wearable devices that can monitor our health and send updates about alarming situations in real-time.

Still, theres an emerging need for transformation in the field of medicine. We still have drugs that address the concern of a mass population, only to leave a few with side effects. Similarly, diseases like cancer do not have any permanent remedy or targeted course of medication that treats the patient well without leaving them with any side effects. Similarly, people over the age of 50 are one of the fastest-growing demographic groups around the world. Its creating a lot of challenges for the global economy and the healthcare sector. These people need to be provided with efficient care and medical support that is targeted towards the longevity of their lives.

The Longevity Industry that provides healthcare support to the population above 50 is turning into a multi-trillion dollar industry, with close to 260 companies in the UK alone. Any progress in the longevity distribution at scale will have a huge impact and multiplicative effects on economies and societies around the world. After all, it would be a huge loss if the experienced population who have been responsible for more than a few innovations in the world are facing sudden deterioration in health in a way that reduces their quality of life. Not only will it be a huge loss to the economies but also result in increased dependency on the healthcare system. Having said this, artificial intelligence has a lot of potentials to manifest in this field and come up with solutions that target the emerging needs of the population accurately.

Research indicates that increasing the lifespan of humans even by one year will decrease the suffering of tens of millions of people and improve the quality of life for billions of others. One such effort in this direction is personalized medicine that targets the individual needs of humans with precision. So, lets say that if a person has asthma, precision medicine will only focus and target the cells that are responsible for asthma and help in regenerating them. This would leave other portions or tissues of the human body untouched and treat only what was needed. Therefore, in place of treating generalized symptoms, AI can help shift medicine towards prevention, personalization and ultimately precision.

With the advent of digitization in the healthcare sector, more and more patent records are going digital. This practice is helping researchers and medical experts understand the history of a patient in detail with the past treatments and health support theyve received. The vast amount of data collected from thousands of such medical records can be studied and used by AI to understand how a particular treatment can impact a particular gene inside the human. Moreover, digitization is also enabling researchers from all walks of life to work together, thus, laying an excellent foundation for biotechnology and computer experts to work together towards personalized medicine.

For example, CRISPR is a gene-editing technology that is being used to target the DNA sequences precisely. With this, medical experts can deliberately activate or inhibit certain genes in human beings. This demonstrates that there is a strong ability to target an individuals distinctive molecular and genetic profile, thus opening up new opportunities for personalized medicine.The National Institute of Health describes precision medicine as an emerging approach for the treatment of diseases and their prevention, which takes a persons gene variability, environment and lifestyle into account. It requires the assistance of deep learning algorithms that can learn from the data at an unprecedented rate and combine the knowledge of medical experts to reach a decision.

However, precision medicine will not be the end of human touch. It will still require vast expertise of medical experts to analyze the results obtained from machines and understand its real-world implications for the patient. With wearable devices, electronic health records and information about the geographic and demographic history of the patient, deep learning algorithms in AI have a lot of potential to device personalized medicine for people that target precision issues with high accuracy.

This article was originally published on Towards Data Science byJames Warner, a business intelligence analyst with knowledge on Hadoop/Big data analysis at NexSoftSys.com

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Thanks to AI, medical treatments are becoming more personalized - The Next Web

With help from Rachana Pradhan and Dan Goldberg

House Speaker Nancy Pelosis drug bill passes the House, but the Senates another matter.

President Donald Trumps FDA pick sails through the Senate and into the soup of vaping and other hot issues.

FDA encourages a focus on pediatric cancer with a shift to molecular targets.

A message from the Partnership for Americas Health Care Future:

New polling shows that lowering costs is the top health care priority for American voters, but embracing a one-size-fits-all new government health insurance system be it Medicare for All, Medicare buy-in, or the public option would mean higher taxes for middle-class families. Get the facts: Learn more.

Happy Friday and welcome back to Prescription Pulse! Were in the home stretch of 2019, just need to get a little thing called government funding done. Know what pharma and device provisions could make it in? Send pharma news, tips and fun reads to Sarah Owermohle (sowermohle@politico.com or @owermohle) and Sarah Karlin-Smith (skarlin-smith@politico.com or @sarahkarlin).

PELOSI DRUG BILL PASSES AND ITS OFF TO THE SENATE GRAVEYARD House Democrats overcame infighting within their ranks Thursday, passing a bill that for the first time would require the government to negotiate prices for costly drugs. The sweeping measure from Pelosi, H.R. 3 (116), hands Democrats a legislative victory to tout in the 2020 electionson a Trump administration priority, no less.

The measure passed 230-192, with two Republicans breaking ranks to support the measure. Eight Democrats jumped party lines to vote for a GOP amendment to replace the bill with H.R. 19 (116), a bundle of bipartisan provisions like measures banning pay-for-delay deals or capping seniors out-of-pocket costs, while avoiding controversial moves like negotiation or price hike caps.

In the Senate, Mitch McConnell has already said the bill is dead on arrival. But the majority leader hasnt committed to taking up his chambers alternative, a bipartisan measure from Senate Finance leaders Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.).

Grassley jumped on the House bill Thursday afternoon, saying it would result in dozens fewer therapies coming to market and that his bill was the only way forward. The House has acted and now the Senate must act, Grassley said.

Trump made vague promises to cut drug prices, including allowing government negotiations, during his 2016 campaign. But several promises have since faltered: courts killed a rule to require prices in drug ads, and the administration discarded a rule eliminating rebates over concerns it would increase premiums. The White House has thrown its support behind Grassleys bill, but the senator has been unable to rally the GOP votes.

Democrats aim to seize control of the drug pricing narrative in 2020. I believe we need real, substantive reforms, said Rep. Katie Porter (D-Calif.), a freshman who flipped her Orange County district last year, "and for a while, so did our president.

HAHN SAILS THROUGH SENATE FDA has a new leader. The Senate voted 72-18 Thursday to confirm the nomination of Washington newcomer Stephen Hahn.

Unlike his predecessor Scott Gottlieb who ultimately won much praise from Democrats who hadn't supported his nomination Hahn has no track record of working and profiting from the drug industry. He also lacks the prolific bibliography Gottlieb accumulated over the years writing on FDA-related policy, making it harder for Democrats to oppose him. Plus, Democrats were eager to see the departure of acting FDA chief Brett Giroir, the HHS assistant secretary of health, a conservative who has backed reproductive health policies opposed by the left.

But will his popularity last? Hahns bipartisan support will be tested by challenging political and public health issues, most notably how to regulate the booming e-cigarette industry amid an outbreak of serious lung illnesses associated with some vaping products.

The Trump administration promised a ban of flavored vaping products in September but in November retreated from that position after an outcry from free-market advocates and the vaping industry.

Hahn offered few hints throughout his confirmation process on how he would deal with vaping or other controversial topics like whether FDA should permit the importation of drugs from overseas to lower medication costs.

NEW REQUIREMENTS FOR PEDIATRIC ASSESSMENTS OF CANCER MEDS The agency issued draft guidance Thursday outlining how it will implement a provision in a 2017 law designed to ensure more cancer drugs are studied in children. Earlier laws requiring pediatric studies of drugs developed for adults only applied if children suffered from the same disease. But most adult cancers rarely occur in children, leading to gaps in pediatric cancer drug development.

Molecular targets a game changer: Researchers have found that a molecular-targeted drug that works to treat one cancer in adults may treat a different cancer in children if the same molecular target is relevant to both.

Sponsors of new cancer drugs for adults will now need to submit a report on pediatric cancer investigations for the drug with their marketing application to FDA, if the agency determines the target to be substantially relevant to a pediatric cancer. The requirements apply to drug applications submitted on Aug. 18, 2020 or later.

The guidance described how FDA will determine whether a molecular target is relevant and explains what should be in an initial pediatric study plan. FDA says studies described in the plan should evaluate dosing, safety and preliminary efficacy.

PHRMA SUES OVER OREGON DRUG PRICE LAWS The drug lobby on Monday challenged as unconstitutional two Oregon laws aimed at boosting transparency around prescription drug prices and increases, Portland Business Journals Elizabeth Hayes reports.

A measure passed last year, OR HB4005 (18R), requires manufacturers to submit a report to the Oregon Department of Consumer and Business Services when a drugs price rises over a threshold, explaining the hike and listing costs for making and selling the medicine. A newer provision, OR HB2658 (19R), mandates that drugmakers give 60 days notice on price increases.

A coalition of hospitals, insurers and health care advocates backed the first bill, but PhRMA said both measures were misguided and unconstitutional. The state should focus on capping out-of-pocket costs or give patients more of the negotiated savings on drugs, it said in a release.

Colorado issues report on strategies to lower drug costs Potential quick win policies that the state may pursue include price transparency related to drug price increases or PBM payments; requiring drug rebates to be passed through to employers and patients; and aligning the states importation policy with a potential expansion of federal regulations that the Trump administration is pursuing. Colorado Gov. Jared Polis has made health cost containment a priority and is one of a handful of states pushing the Trump administration to allow importation of prescription drugs from Canada.

SUPREME COURT REJECTS ARIZONAS CASE AGAINST SACKLERS Mark Brnovich, Arizonas AG, had taken the unusual step of asking the nations top court to hear his lawsuit, which accuses the Sacklers, the family behind Oxycontin-maker Purdue Pharma, of funneling $4 billion from the drug company while it faced huge liability for its role in the opioid crisis. Arizona is one of thousands of jurisdictions suing Purdue, which has declared bankruptcy. A bankruptcy judge put a hold on pending lawsuits but Brnovich decided to try his luck with the justices anyway.

RESEARCHERS CRITICIZE FINANCIAL DEPENDENCE ON INDUSTRY A group of researchers has demanded that medical research, education and practice become independent of commercial influences, Politico Europes Judith Mischke reports. The international researchers, clinicians, regulators and citizen advocates warned in a British journal that while everyone wants to ground healthcare decisions in "trustworthy evidence," there are still "widespread financial conflicts of interest across medical research, education, and practice.

In the United States, about 60 percent of medical research is industry funded, they noted. In some cases, "published outcomes of industry-sponsored studies tend to favor sponsors products, creating a 'sponsorship bias' in the evidence base that overplays benefits and underplays harms, the group writes.

They offer two solutions: Governments should pass laws requiring public disclosure of company ties, or regulators should bar public health organizations from receiving industry funding.

A message from the Partnership for Americas Health Care Future:

More than 180 million Americans rely on employer-provided coverage and new polling shows a majority of voters would rather build on whats working in our current health care system than replace it with a one-size-fits-all new government-controlled health insurance system.

Whether its called Medicare for All, Medicare buy-in or the public option, American families would face unaffordable costs and lower quality care under a one-size-fits-all system the exact opposite of what they want. See the results from the tracking poll here:Learn more.

PRESCRIPTION DRUG FACTORIES POLLUTING WATERWAYS Wastewater treatment plants are not typically equipped to remove pharmaceuticals from the waterflow, and drug cocktails have shown up in rivers across the U.S., reports Stat News Natasha Gilbert. In one area downstream of a Morgantown, W. Va., plant, an anti-seizure medication was measured at nearly 90 times the amount considered safe for wildlife. Stat and Type Investigations identified Mylan, Pfizer, Teva and three others as drugmakers dumping substantial levels of pharmaceuticals into the watershed.

CAR-T MANUFACTURING PROBLEMS PLAGUE NOVARTIS Novartis has had to give away some of its CAR-T cell therapy, Kymriah, because the personalized blood cancer treatment, made from a patients immune cells, havent met FDAs specifications, Biopharma Dive reports. In those cases the company delivered the treatment as if were an unapproved drug, through an expanded access protocol. In other cases, the company hasnt been able to use the product its made at all. Novartis presented real-world data this week that showed that even when the product didnt meet specifications it could attack cancer with no increased safety risk. Manufacturing is just one of the hurdles for commercializing the personalized medicine, which costs $475,000 for leukemia and $373,000 for lymphoma.

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Pelosi drug bill passes ... and it's off to the Senate graveyard - Politico