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Archive for the ‘Personalized Medicine’ Category

Personalized Medicine – Genome.gov

Tuesday, October 26th, 2021

Personalized medicine is a fantastic opportunity to take a "one size fits all" approach to diagnostics and drug therapy and prevention and turn it into an individualized approach. We all are similar, of course, but we are also different. And the idea that medicine would be applied in a fashion that ignores those differences can't be any more correct than going to the shoe store and buying any old pair of shoes without checking the size. Genomics is playing a big role in the emergence of personalized medicine, 'cause it gives us a window in a very specific molecular way into those differences between us and allows the opportunity for making individual predictions about disease risk that can help somebody choose a prevention plan that is right for them. It also allows the possibility in some instances of picking the right drug at the right dose for the right person instead of the "one size fits all" approach to drug therapy. And ultimately it will be hard to see how any kind of medicine will not be affected by this as we learn more and more about the individual, and as many of us find our complete genomes being sequenced and placed into our medical records to empower that kind of personalized approach. Lots of work to do here, but maybe the biggest revolution in medicine in a very long time.

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Precision or Personalized Medicine | Precision Medicine …

Tuesday, October 26th, 2021

What is precision medicine?

Precision medicine is a way health care providers can offer and plan specificcare for their patients, based on the person's genes (or the genes in their cancer cells). It's sometimes called personalized medicine or personalized care. Precision medicine looks at how a specific gene change (gene mutation) might affect a person's risk of getting a certain cancer or, if they already have cancer, how their genes (or genes in their cancer cells) might affect treatment.

The approach uses information from genetic tests to help doctors put together a plan for care that usually involves very specific recommendations. In some cases, precision medicine can help make a more accurate diagnosis and improve treatment. In other cases, it can help people make decisions about healthy habits, earlier screening tests, and other steps towards prevention if they are at risk for a particular cancer.

Your health care providers might not use the exact words "precision medicine" or "personalized medicine." Instead they might talk to you about genetic, genomic, DNA, or molecular testing. Or they might talk about looking for biomarkers or getting a genetic profile. These are ways doctors and other health care providers might use a precision medicine approach when they are planning your care.

Precision medicine is based on knowing the effects of certain gene mutations (changes). When thinking about precision medicine, it can be helpful to understand what gene mutations are and how they can affect a person's risk for cancer or treatment for a cancer.

Each cell in a person's body has DNA, which contains our genes. Genes are the instructions your cells use to make proteins needed to keep your body working normally.

When cells divide to make new cells, the genes inside those cells are copied. A gene change happens when there's a mistake in the copying process. Sometimes these changes come from a parent (inherited gene changes). But they can also happen sometime later in life (acquired gene changes). Some gene changes can be harmful, while others may not cause any problems.

All cancers are caused by a genetic change or mutation of some kind. Cancer cells are mutated versions of normal cells, meaning something changed in a normal cell to make it turn into a cancer cell. Experts agree that it takes more than one gene mutation in a cell for cancer to happen.

While we don't yet know all the genes and mutations that could be involved in the development of cancer, there are some we know about and can test for. Depending on the type of mutation, an abnormal gene change might make a person more likely to develop a certain cancer. Or, if they already have cancer, the abnormal gene might mean that the cancer may not respond well to a certain type of treatment or drug. In some people with cancer, a specific gene mutation might mean that their prognosis (outcome) is better or worse than someone with the same cancer who does not have that gene change.

For example, when a person is diagnosed with cancer, they often get the same treatment as other people with that type of cancer. Sometimes a specific drug is used to treat a cancer with a certain abnormal gene. But gene changes might be different from one person to another, even if they have the same type of cancer. Because of this, each of those people might have a different response to the same drug. For certain cancer types, doctors can test for gene changes that can tell them if a person might respond better to one drug than another.

You can learn more in Genetics and Cancer.

Precision medicine is being used for certain cancers to help know what tests and treatment are best. Doctors might use precision medicine to help them:

Sometimes precision medicine is used for people with certain cancers or who are at higher risk for developing certain cancers. For example, a person might realize cancer runs in their family, or their doctor might notice a pattern of cancer in their family. In these cases, the patient might meet with a certified genetic counselor and consider having genetic testing. The testing can show if they have a gene change or mutation that puts them at a higher risk for certain types of cancer. If so, the doctor might recommend screening and other tests (often at a younger age than usual) to help find cancer early, and prescribe medicines or suggest healthy habits that might help lower cancer risk.

For people with a cancer diagnosis, their tumor might be tested for certain types of gene changes or proteins made from those gene changes.This testing can provide information about how their cancer grows and spreads. These tests might be called biomarker tests, chromosome tests, gene tests, or biochemical tests. It might be done using a blood or saliva sample, biopsy tissue, or body fluids. If the test is done using a biopsy sample (from a tumor), it'sdone in a special lab and might be called by different names, such as DNA mutational analysis, genomic testing, proteomics, biomarker testing, tumor profiling, cytogenetics, next generation sequencing, or molecular testing.

In some cancers, the gene testing done on a tumor can affect treatment choices. This is because certain gene changes can affect how a tumor responds to certain treatments. And some tumors have gene changes that are different from other tumors of the same type. For example, not every melanoma skin cancer will have the exact same gene mutations.This means these tumors might not respond to a treatment the same way. The goal is to give a treatment that can target a gene mutation, without causing too many side effects, and to avoidgivingtreatments that might not work. You can read more about 2 types of treatment often used in precision medicine: targeted therapy and immunotherapy.

You can also learn more in How Genes Can Help in the Diagnosis and Treatment of Cancer.

It's important to understand that precision medicine is not used for every cancer. However, the hope is that one day, treatments will be customized to the specific gene changes in each persons cancer. Much research is being done in this area.

Some of the more common cancers where precision medicine is being used to help with treatment decisions include:

If a treatment is available to target a gene mutation that's common in your type of cancer, you (or your tumor) will likely be tested for it. You might need to ask your doctor some questions to know if testing was done. People with the types of cancer listed above are usually tested for certain gene changes when they are diagnosed, or shortly after. Some cancers are also tested if they get worse or come back.

Access to the latest precision medicine research might be limited. A lot still needs to be learned about how precision medicine can be used in cancer. Researchers are trying to fill those gaps, both in labs and in clinical trials.

Many clinical trials are done with patients who have specific types and stages of cancer. But to be part of a precision medicine clinical trial, a person must have a certain genetic change that can be targeted by amedicine that's being tested. And precision medicine clinical trials are often available only at larger cancer centers. This means sometimes the chances to be part of a clinical trials can be limited.

Even when precision medicine is available outside of a clinical trial, it might not always be used as well as it could be. For example:

It's important to ask questions and know all options that are available to you.

Experts believe precision medicine could help lower health care costs in some ways. This is because precision medicine can help guide doctors in choosing the right tests, which can then help them choose the treatments that will work best and hopefully have the fewestside effects. This means a patient might avoid getting treatments that are not likely to work well, along with unnecessary side effects.

But precision medicine can also increase some costs. For example:

If you don't have cancer, but are concerned about your cancer risk because of a family history or other reason, here are some questions you might want to ask your doctor:

You can learn more in Understanding Genetic Testing for Cancer.

If you have cancer, especially one of the cancers listed above in "Types of cancer precision medicine is used for," here are some questions you might want to ask your doctor:

You can learn more about what questions to ask in Understanding Your Options and Making Treatment Decisions.

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Precision Medicine Market to reach US$ 114,891 Mn by end of 2028, Says Coherent Market Insights – PRNewswire

Tuesday, October 26th, 2021

SEATTLE, Oct. 21, 2021 /PRNewswire/ -- Precision medicine sometimes referred to as "holistic medicine" is a highly specialized way to tailor personalized medicine to specific individuals, taking into consideration differences in genetics, histories, and environments. The aim of precision medicine is to only target the appropriate treatments to the appropriate patients at the appropriate time with the best possible outcomes. It is used to make medical interventions more efficient and less harmful to patients. In practice, precision medicine often involves working with and coordinating other health care teams, including primary care providers, specialists, surgeons, clinicians, nurses, and other doctors, all of whom work together to provide the most effective care. Precision medicine includes diagnostic tests, which are used to detect genetic variations that may affect a person's responses to medication or disease. These tests determine whether the patient's genetic or environmental factors are interfering with the effectiveness of the drugs, devices, or procedures being used in the treatment. The accuracy of such tests has improved a lot over the past few years.

The global precision medicine market is estimated to account for114,891.8Mn in terms of value by the end of 2028.

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Market Drivers:

Growing development of Big Data analysis and expansion of the IT sector is propelling growth of the precision medicine. Big data analysis and IT easily analyze, crunch, and store the necessary data which enable the physician to provide precision medicine. Key players are investing heavily in precision medicine. For instance, in August 2019, BioCity, the life science incubator and business announced an investment in precision medicine biotech, Kinomica Ltd., via the Innovate UK Precision Medicine Investment Accelerator.

An increasing number of R&D programs for enhancing precision medicine is fostering growth of the market. For instance, in October 2021, Amgen and Neumora Therapeutics, Inc. a clinical-stage biopharmaceutical company pioneering precision medicines for brain diseases, announced a strategic partnership to advance neuroscience discovery, development, and commercialization. The companies have partnered on programs by applying Neumora's proprietary precision neuroscience platform to insights generated by Amgen's deCODE genetics and human data research capabilities.

Market Opportunities

Key players are adopting various strategies to accelerate the development of the precision market across developing regions. This is expected to provide room for potential growth opportunities for the market. For instance, in August 2021, Clinical trial organization (CRO) Precision for Medicine has partnered with Trialbee, a patient selection, and selection firm to address the complexities of clinical development. According to this partnership, they will use Trialbee's analytical features and Precision for Medicine's wide range.

Development of bioinformatics by key players to support the research of precision medicine is projected to offer lucrative growth opportunities. For instance, in June 2021, Indivumed GmbH announced the launch of nRavelTM, a unique AI discovery platform for oncology and precision medicine. The platform combines IndivuType's deep multi-omics data with elaborate disease models, high-powered automated Machine Learning tools, and a comprehensive suite of advanced analytics tools.

Market Trends

Precision medicine has gained lots of popularity in the treatment of cancer due to its positive result. Thus, the increasing prevalence of cancer is expected to uplift the growth of the market. According to the World Health Organization, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. The economic impact of cancer is significant and increasing. The total annual economic cost of cancer in 2010 was estimated at US$ 1.16 trillion.

Growing need for personalized medicine will favor positively impact the growth of precision medicine. According to the American Association for Clinical Chemistry, the most common conditions using personalized medicine today are diabetes (45%), common cancers (38%), and neurological diseases (33%). These numbers are all set to increase significantly in the near future.

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Competitive Landscape:

Major players operating in the precision medicine market are Intomics, Nanostring Technologies, Inc., Ferrer Incode, Tepnel Pharma Services, Pfizer, Inc., Novartis AG, Merck & Co., Inc., Qiagen N.V., Teva Pharmaceutical Industries Ltd., and Quest Diagnostics.

Market segmentation:

Global Precision Medicine Market, By Technology:

Global Precision Medicine Market, By Application:

By Geography:

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The biggest emerging technologies of the past 10 years – World Economic Forum

Tuesday, October 26th, 2021

Significant technological advances over the past decade have changed the way we live, work and interact with each other.

Yet, many of these developments either happened behind closed doors in research laboratories and private companies or became so quickly ingrained in our daily lives that they often went unnoticed.

Every year, experts convened by the World Economic Forum and Scientific American make predictions about the emerging technologies expected to have major social, economic, and environmental impacts worldwide.

While some of these technologies have been catapulted into public consciousness and are fully integrated into our lives, others have been slower to gain momentum.

In the run-up to the 10th Anniversary edition of the Top 10 Emerging Technologies Report, launching 16 November, we take a look at some of the technologies from the past nine reports and ask: did the technology change the world, or did it fail to fulfil its potential? How is it impacting lives today, and where is it headed?

Given the poor success rates of treatments for things like cancer and depression, medical professionals have been trying to tailor treatments to individual patients for some time.

A decade on, there is renewed cause for optimism, says Dr. Elizabeth ODay, CEO and Founder of Olaris, Inc: In the next 5 to 10 years, we will be able to get the right drug to the right patient at the right time at the right dose and optimize all of these parameters.

We spend billions of dollars every year on drugs or treatments that dont work. Personalized medicine stands to correct this. Not only are we going to improve [patient] outcomes, but we can cut costs on drugs and treatments that arent going to benefit an individual.

But for personalized medicine to benefit everyone, scientists trying to figure out which treatments work best for which patients will require data from as diverse a group as possible.

We need all ethnicities, all geographies, people from all socioeconomic backgrounds to be involved in this process, or risk increasing health disparities, and thats not the future of medicine that we want to create.

Genomic vaccines vaccines made from DNA or RNA that encode desired proteins have been in development for many years but saw unexpected success in tackling the COVID-19 pandemic.

The technology was on our list of Top 10 emerging technologies in 2017, and three years later, Pfizer-BioNTech and Moderna created the worlds first mRNA vaccines to tackle the worlds biggest health threat.

Equitable distribution of vaccines is a global challenge, but in future, access to genomic vaccine technology could be democratized, believes Prof. Robin Shattock, Chair of Mucosal Infection and Immunity at Imperial College London.

I think well see many governments around the world wanting to establish their own manufacturing capacity and because you dont need a large manufacturing facility, it could move to a situation where there are many regional manufacturing centres that have the hardware and what becomes distributed is the software the genetic code for the next pandemic pathogen or the next chronic target.

Im hoping it will revolutionize a lot of what we do. Its not a magic bullet, it wont replace all other types of vaccines, but it will have an important role to play in public health.

In 2019, we identified that droid friends and robot assistants would increasingly become part of everyday life, looking after the elderly and educating children - and the pandemic has accelerated this trend due to the need to maintain a social distance.

But theres still a little way to go. As robotics become more integrated into peoples lives, they will need to be designed to detect, interpret, and respond to human behaviour, according to Henny Admoni, A. Nico Habermann Assistant Professor at Carnegie Mellon Universitys Robotics Institute.

In our consciousness as a society, weve been thinking about social robots for a very long time, but the reality is that most of the robots that are out in the world right now are much more physical robots that tend to be isolated from humans.

The World Economic Forum was the first to draw the worlds attention to the Fourth Industrial Revolution, the current period of unprecedented change driven by rapid technological advances. Policies, norms and regulations have not been able to keep up with the pace of innovation, creating a growing need to fill this gap.

The Forum established the Centre for the Fourth Industrial Revolution Network in 2017 to ensure that new and emerging technologies will helpnot harmhumanity in the future. Headquartered in San Francisco, the network launched centres in China, India and Japan in 2018 and is rapidly establishing locally-run Affiliate Centres in many countries around the world.

The global network is working closely with partners from government, business, academia and civil society to co-design and pilot agile frameworks for governing new and emerging technologies, including artificial intelligence (AI), autonomous vehicles, blockchain, data policy, digital trade, drones, internet of things (IoT), precision medicine and environmental innovations.

Learn more about the groundbreaking work that the Centre for the Fourth Industrial Revolution Network is doing to prepare us for the future.

Want to help us shape the Fourth Industrial Revolution? Contact us to find out how you can become a member or partner.

A social robot is not a replacement for social interaction, but becomes a medium through which communities can engage and people can interact.

Its really important as we build robots into our lives that we consider the ethical implications of robotics, who has access to these different technologies and what these technologies are perpetuating in terms of the social norms that are already embedded in society.

Written by

Greta Keenan, Programme Specialist, Science and Society, World Economic Forum

Kate Whiting, Senior Writer, Formative Content

The views expressed in this article are those of the author alone and not the World Economic Forum.

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Innovative Joint Program in Computational Precision Health at UC Berkeley and UCSF Aims to Improve Quality and Equity of Health Care – UCSF News…

Tuesday, October 26th, 2021

October 20, 2021

By Tiffany Lohwater UC Berkeley

The University of California, Berkeley and the UC San Francisco on Oct. 20 jointly launched a new, one-of-a-kind program in computational precision health, a significant step toward advancing this new field and, ultimately, improving the quality and equity of health care.

The partnership positions the two world-renowned universities at the forefront in creating a new field at the intersection of medicine, statistics and computation. By creating a joint faculty group between UC Berkeley and UCSF, the two universities will simultaneously advance computing and data science with biomedicine and health, enabling solutions that would not have been imagined by either discipline alone.

Learn more about the computational precision health program.

Visit the site

The research of the joint faculty will enable new and more personalized techniques for the prevention, diagnosis, treatment and management of disease. Working together, the two universities will develop new methods for data-driven clinical care, early detection and intervention, new ways to predict outcomes, and new targeted treatments which are both more effective and have fewer side effects. This ground-breaking faculty and educational program will transcend traditional boundaries among institutions, disciplines and scholarly communities to transform the future of health and health care.

The program will train the next generation of researchers to design, build and test innovations such as machine learning, digital health and clinical decision support systems within real-world clinical and public health settings to ensure that solutions meet real-world needs. Recognizing that algorithms are currently being created that too often exacerbate rather than mitigate racial and other biases, the program will ensure that equity, fairness, accountability and transparency will be hallmarks of all of its educational and research activities.A PhD degree program is anticipated by 2023 that will be jointly conferred by UC Berkeley and UCSF, leveraging the institutions research strengths: computer science and statistics at Berkeley, health care and health sciences at UCSF, and population and public health sciences at both campuses.

A gift of $50 million has been provided to UCSF and Berkeley by an anonymous donor to support the international search and hiring of four new faculty members in the next year and initiate development of the graduate program. The two institutions have committed to collectively secure an additional $100 million in funding from other sources such as philanthropy, federal grants and industry partnerships.

The joint program is being led by co-directors from both campuses who have expertise in medicine, public health and data science: Ida Sim MD, PhD, professor of medicine at UCSF and Maya Petersen MD, PhD, associate professor of biostatistics and epidemiology at Berkeley.

Maya Petersen, MD, PhD. Photo by UC Berkeley

The current evidence-based approach in medicine has led to health interventions and treatments that work on average for selected and often non-representative patients, said Sim, a primary care physician and informatics researcher. Many patients and patient populations face risks to their health from the use of data that are incomplete, data systems and infrastructure that are not well connected, and inherent bias in how data are collected and analyzed.

We can work to address these issues by equipping our students to understand the underlying contexts of equitable health care while simultaneously developing computational solutions to help instead of harm, she said.

Petersen and Sim believe that advanced data analytics and digital infrastructures are needed to allow next-generation computational health solutions to learn from every patient intervention and enable every patient to benefit from the latest data and evidence on successful health interventions. This vision can only be achieved, they say, if the underlying computational and analytic tools are conceived, tested and validated for the health care needs of diverse individuals and communities.

For an example of why this is needed, just look at the COVID-19 response in the U.S. and globally, said Petersen, who developed mathematical models for San Francisco and Bay Area communities that helped predict cases and hospitalizations during the pandemic. Theres so much more we can do to deliver on our promise and improve our healthcare and public health systems. We must serve the needs of populations and communities as well as individuals, and work to address existing systemic inequities in health.

Through this program, we aim to create a pipeline of diverse leaders committed to this goal, including those communities most impacted by existing health inequities. Embedded in all core courses in our curriculum will be a focus on diversity, equity and inclusion asking who are solutions built for, and who are solutions built by human-centered design, and the consideration of the ethical implications and societal impacts of this work, Petersen said.

Shared administration of the program by Berkeleys Division of Computing, Data Science, and Society and UCSFs Bakar Computational Health Sciences Institute, along with the involvement of 39 faculty in multiple schools and departments at both UC campuses, will help facilitate additional education and research collaborations in computational precision health.

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How FDAs OTC Ruling Will Fuel The Hearables Revolution – Forbes

Tuesday, October 26th, 2021

The long-awaited FDA guidelines for the Over-the-Counter (OTC) Hearing Aid Law were finally released last week. The move by the FDA will break a 50-year stronghold that a handful of players have had on the hearing aid market and on the pocketbooks of the millions of Americans who need relief from hearing loss but have not been able to afford their exorbitant prices.

FDA guidelines for the Over-the-Counter (OTC) Hearing Aid Law were released.

Proponents of the new law including the administrations of Presidents Obama, Trump, and Biden claim the bill will help democratize competition and incentivize a wider range of innovative solutions for the 48 million Americans suffering from mild-to-moderate hearing loss. In addition, the OTC ruling includes guidelines for Personal Sound Amplification Devices (PSAPs), which are non-medical and open to a broad interpretation with far-reaching commercial applications.

Considered to be the third most common physical condition after arthritis and heart disease, untreated hearing loss has been linked to anxiety, depression, social isolation, reduced mobility, falls, dementia, and lower quality of life and relationships. It is also an issue facing more than just the elderly populations. Hearing loss also affects millions of people under the age of 35, as well as kids who go untested and consequently struggle with learning.

The Real Game-Changer

The real game-changer, however, will be at the intersection of wellness, fitness, and consumer audio products. The regulatory shift, when combined with exponential advancements in sound and wellness tech, will help fuel the Hearables Revolution and what is estimated to become a 93 billion dollar Hearables (in-ear audio devices) market by 2026. The long-term impact will be on the Amplified Future: the full integration of audio as a key component of personalized and precision medicine.

Amplified Future

Sound Health: Hearing Aids vs Hearables

Until now, the hearing aid industry has set the medical standards shaping consumer concerns around hearing loss. Hearing aids also represent a growing high-ticket reimbursable market thats worth $1.6B in the US, and slightly more in China.

The Big 5 hearing aid companies, however, only serve 14% of people suffering from hearing loss in the US. They have done little to address the social stigma, help younger and uninsured populations, or keep costs down. That leaves the majority of the population unserved: those dealing with mild to moderate hearing loss who dont require medical-grade hearing aids or implants.

Hearables Projected Market

Both OTC Hearing Aids and Hearables have an opportunity to fill a large part of that market gap while providing products that deliver infinitely more features than traditional hearing aids at a fraction of the cost. Smart-audio and wearable product manufacturers are already lining up to serve that population, expand their brand footprint, and get their slice of the Hearables pie.

Merging Audio and Wellness Expertise

In 1964, engineer and MIT professor Amar Bose founded his audio brand so he could dramatically improve the fidelity and transform the listener experience for recorded music. (He personally loved listening to classical music). Over 50 years later, the company in been making moves into both medical hearing aids and wellness-based consumer Hearables. They have already introduced their first FDA-cleared direct-to-consumer self-fitting hearing aid for less than 1/3 of the price of traditional hearing aids and are continuing development of their in-ear sleep aid technology, SleepBuds.

Bose Earbuds

The new FDA ruling gives Bose an opportunity to create more solid revenue streams for their new healthcare division as they seek to establish themselves as a credible and trusted wellness brand.

According to Steve Romine, VP of Bose Hear, Were thrilled the FDA has announced the issuing of its draft OTC hearing aid regulations. This marks a great moment for the millions of Americans experiencing hearing loss today...For now, theres renewed optimism for hearing loss sufferers who have put their hearing health on the back-burner due to the numerous barriers to getting the help they need to hearing better again.

In another marriage of consumer audio tech and hearing health, Sennheiser sold its consumer product division to Swiss hearing aid company Sonova last year for $240 million. In addition to giving Sennheiser immediate credibility and positioning in healthcare, the move will allow Sonova to bridge into non-medical consumer audio products.

Apples Slow But Steady Advances Into the Future of Health

The most valuable tech company in the world (currently valued at over $2 trillion) Apple is steadily building out its ecosystem and product lines for in-ear audio, fitness, and health. Apple recently announced their conversation boost feature for more precise listening through their AirPods, and the company is exploring other hearing enhancement features that will go beyond the benefits of noise reduction and their latest announcement spatial audio. There is also talk in the air about temperature and posture monitoring with their new AirPods Pro, as well as using iPhones to help diagnose depression and cognitive decline.

Apple has already staked a majority claimed for what will become the most coveted and connected real estate on the human body - the human ear. Last year, AirPods enabled Apple to capture over one-third of the high-end consumer earbud market. Various sources are saying that if Apple spun off their AirPods division into to a separate company, 2020 revenues for the spinoff would have surpassed those of Uber, Adobe, Nvidia, and Spotify.

Apple Airpods is a game changer

Apple continues to add value to their AppleFit programs with health and wellness monitoring features via their primary wearable, the Apple Watch, in sync with iCloud the the iPhone. In 2020, however, AirPods unit sales had more than doubled those of the Watch, giving another clear indicator of the continued migration from wearables to hearables. While I doubt Apple will move fully into the OTC hearing aid market, as suggested by the recent The Wall Street Journal article, the fashionable tech giant is well-positioned in both the consumer marketplace and the human ear to make a big play in the Amplified Future, focusing on the most scalable health, audio, and wellness features.

New Players In The Game

Companies like CES 2020 Honoree & Consumer Technology Association (CTA) Innovation Award winner Nuheara, started developing their Hearable devices - IQbuds - after a successful 2016 Indiegogo campaign and 2017 CES launch.

Nuheara

Earlier this month, Nuheara announced that it has commenced its clinical trial with the National Acoustics Laboratories (NAL), to support its planned expansion into clinically tested and regulatory-approved hearing aids.

Japanese manufacturer Olive Union has been targeting the younger populations and the 86% of the 48 million Americans who suffer from mild to moderate hearing loss and dont require medical-grade hearing aids. In the process of trying to de-stigmatize hearing aids, however, they are coming up with some very stylish hearable offerings, like their Olive Pros and SmartEar Plus that combine hi-end personalized audio features to provide style (they have a similar form to AirPods), hi-fidelity music listening (via the ability to choose between Music Mode and Hearing Mode), noise reduction, and customizable hearing enhancement features via their phone app.

Olive Pro hearing aids

Olive Union closed a $7 million B round in April 2021, bringing their total funding raised to date $20 million for their next-generation smart hearing technology.

Kokoon sleep phones have integrated EEG sensors and other sleep-specific features to capitalize on the burgeoning sleep market. Although they offer a more traditional headphone (over-the-ear) design, their software interface provides more content options than Bose in-ear SleepBuds including streaming third-party music sources via Bluetooth from your mobile device. Because the global epidemic of sleep problems and the consumer demand for better non-pharmaceutical solutions are not going away anytime soon, you can expect a new wave of innovations in hearables for sleep in the near future.

Why Consumer Audio Companies are Racing Into Health & Wellness

Why are investment funds, new ventures, and audio heavyweights jumping headfirst into the health tech pool?

The global market for earbuds and headphones is growing steadily as wireless becomes the norm and new features continue to improve performance and usefulness. A report from Grand View Research, set the value at $25 billion in 2019 (before witnessing the record-breaking 2020 AirPods sales), with a projected compound annual growth rate (CAGR) of over 20% from 2020 to 2027. The total wearables market was worth nearly $70B in 2019, with the hearables sector (including headphones), making up $28B of that.

Amazon, Apple Or Spotify: The Musical Race To Dominate Digital Wellness

Even digital music and content companies are looking at wellness as a way to differentiate, create new revenue streams, and attract customers away from their competitors. The evolution of higher fidelity and feature-rich hearables will only help their cause.

The audio products market, however, is crowded and highly competitive. That means market caps and lower profit margins for traditional and limited-use audio products. For consumer audio product manufacturers to compete and create exponential growth in the future, they may have to cut their slice from a bigger pie.

According to a report from Precedence Research, the broader Digital Health Market was $181 billion in 2020 and is expected to grow to over $550 billion by 2027. It is predicted that the much broader and exponentially larger global healthcare market will reach $10 trillion by 2022. The largest US healthcare company, McKesson MCK , already has an annual revenue of over $208 billion. While these numbers are inclusive of a number of sectors that make up the massive global health and wellness markets, those are some pretty attractive figures for forward-thinking digital audio product manufacturers to consider.

Why Voice Will Lead Biometrics in Hearables

Even without including digital health and personalized medicine, 2020 wellness expenditures ($4.2 trillion, per the Global Wellness Institute) surpassed over half of total global health expenditures ($7.3 trillion, based on WHO data). That wellness industry represents 5.3 percent of global economic output.

When it comes to the ever-increasing number of startups entering the digital health and wellness space, there seems to be no sign of slowing, especially if you measure future growth by current investments. Global VC funding for Q1 of this year marked a record-setting quarter for investments into Digital Health companies, hitting $7.2 billion - twice that invested during the same quarter in 2020.

As of the close of Q3 2021 according to CB Insights State of Healthcare market report digital health startups have raised $39.6B in funding YTD, already 27% more than 2020 funding totals. Q3 also saw the birth of ten new healthcare unicorns, bringing the industrys total to 91 - the 3rd highest ever.

As audio becomes an increasingly more important health and wellness pipeline for data tracking and content delivery, and wearables continue their migration to high-feature multi-purpose hearables, the overlap of these markets will merge to create a bigger pie.

Apple Earpod Customer

Listen Up: Voice Bring More Value to the Future of Hearables

And lets not forget the exploding Voice Economy which has already established household names by the likes of Alexa, Siri, and Google Assistant. The possibilities at the intersection of voice analytics and personalized health monitoring continue to expand. Anyone who uses their earbuds to make phone calls or voice commands, can likely envision how the human ear will become the #1 place to seamlessly capture biometric health and wellness data from your voice.

Beyond the FDA and Into the Future

There is no doubt that the FDA guidelines released last week will play an important role. One way to look at the FDA ruling is through the disruptive lens of the hearing aid market, but that only provides a narrow view of a complex matrix of forces that are creating, transforming, and connecting a number of much larger markets.

We are entering the Amplified Futureone that will feature ongoing real-time and multivariable predictive analysis by sensor-rich hearables and wearables. In addition to improving how we hear the world, these devices will monitor our vitals on the go and offer real-time recommendations for enhancing our physical and emotional well-being. These same technologies will provide early detection data to help us avoid life-threatening diseases, all as we go about our daily routines, all captured seamlessly through closed-loop systems between our ears, the cloud, our phones and other smart devices.

The companies that build the best UX and ecosystem to successfully bridge more traditional uses of this 2-way audio highway (voice and music), with highly effective, personalized, and convenient health and wellness features will have the best arsenal to win in the Hearables Revolution. Along with the competition, they will also help democratize and de-stigmatize hearing enhancement solutions for the new majority.

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Hollings participating in large national breast cancer study aimed at improving screenings and treatment – Medical University of South Carolina

Tuesday, October 26th, 2021

Getting routine breast exams is something Dag Pavic, M.D., a breast radiologist at MUSC Hollings Cancer Center, stresses all the time. Thats why hes excited that Hollings is participating in a large National Cancer Institute-funded trial, aimed at improving breast cancer screenings and treatment options for women with, and without, health insurance.

Breast screening is our best weapon in the fight against breast cancer, Pavic said. When breast cancer is caught early, the patient has numerous treatment options and usually a very good outcome.

The trial, called the Tomosynthesis Mammographic Imaging Screening Trial (TMIST), will provide insights into which type of screening is best and how to improve future breast cancer patient care. Nationwide, researchers hope to enroll 165,000 women in the trial.

This trial helps us offer more personalized medicine to each individual patient, Pavic said. We have to consider a patients risk of breast cancer and breast characteristics that may alter what may be the best type of screening for that person.

The trial is being supported by the NCI Community Oncology Research Program (NCORP). Nearly 50 million screening mammograms occur each year in the United States, yet it has been decades since a large-scale randomized trial of mammography has been done, said Worta McCaskill-Stevens, M.D., director of NCORP. The evolution of mammography technology provides us with an opportunity to fill in the gaps in our knowledge about two available breast cancer screening tests.

Hollings is currently enrolling women ages 45 to 74 in TMIST. As part of the randomized study, women will receive a mammogram using conventional two-dimensional mammography or the newer tomosynthesis three-dimensional mammography.

Through this trial, we hope to learn whether or not there are differences between 2D and 3D mammography in detecting cancers and advanced cancers and whether one type of mammography results in more false positives and callbacks for further evaluation, Pavic said.

Pavic, who serves as the primary investigator of the TMIST trial at Hollings, said researchers will also collect genetic samples from enrolled patients. These samples allow us to understand and study cancer on a molecular level, which will ultimately lead to better therapies. Once you understand the molecular aspects of breast cancer, you can investigate, produce and use medicine that will target those components.

Pavic said he hopes that the trial also answers two other questions: Is standard-of-care 3D mammography better than standard-of-care 2D mammography? And how frequently should patients be screened for breast cancer?

The trial is being offered at two MUSC locations Hollings Cancer Center in downtown Charleston and MUSC Womens Health at East Cooper Medical Pavilion. To date, 90 women who have enrolled in the trial at MUSC locations, and Pavic said that, eventually, he hopes to have several hundred enroll before trial enrollment ends in 2024.

Patients should be excited to participate in this trial because they can be part of something for the greater good, he said. We have an opportunity to gain a better understanding of breast cancer screenings and treatments. That will ultimately help to save lives in the years to come.

Patients interested in enrolling in TMIST should contact study coordinator, Kristin Thompson, at thompskn@musc.edu or 843-792-6463.

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Johnson & Johnson preps for first CAR-T launch with a new patient support program, a dedicated sales team and more – FiercePharma

Tuesday, October 26th, 2021

Johnson & Johnson and partner Legend Biotech are expecting an FDA decision for their first CAR-T product, cilta-cel, in November. To prepare for the upcoming launch of the personalized cell therapy, the Big Pharma company is planning a specialized patient support program, a dedicated sales team and more.

J&J intends to roll out a customized programto help cilta-cel-prescribed multiple myeloma patients navigate the treatment journey, Serge Messerlian, Janssens U.S. oncology president, said in a recent interview.

CAR-T therapies modify a patients own T cells to make them better weapons against cancer bearing a specific biomarker. For such a personalized medicine, one needs to be very thoughtful not just [about] the product, but theres a very important service component to that, Messerlian said.

RELATED:J&J, Legend Biotech's multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS' Abecma

Because of the complexity in production, CAR-T products can be pricey. Before cilta-cel, Bristol Myers Squibbrecently introduced a rival BCMA-targeted cell therapy, Abecma, at a list price of $419,500. Patients need to travel to designated treatment centers to have theirT cells drawn and later to receive the final product. They must also monitor for a potentially life-threatening side effect known as cytokine release syndrome after treatment.

For J&J'sprogram, each patient will get one-on-one assistancenavigating access challenges and help with the logistics associated withtreatment, Messerlian said. For the upcoming launch, J&J isworking on CAR-T site initiations and making sure the market is ready to receive the medicine. Although the company already has a popular multiple myeloma therapy, Darzalex, cilta-cel will have a separate sales team, he said.

J&J has a separate personalized patient assistance program for Darzalex, called Janssen Compass, which also covers prostate cancer med Erleada. The company is now rolling out Janssen Compass on a national scope after a limited run, Messerlian said.

Compass is a very patient-centric, patient-oriented platform; it almost serves like a shepherd, Messerlian explained. In Janssen Compass, a single point of contacta nurseis assigned to help bring the right resources to a patient to manage obstacles along the way, including access challenges and side effects.

RELATED:J&J cell therapy partner Legend carves out production foothold in Belgium as myeloma drug nears finish line

About half of the patients that get on any drug drop off within six months, Messerlian noted, and not all of them are related to costs.

Sometimes, patients dont understand what to expect on the treatment journey or fully acknowledge the benefits ofthe medicine, so they may not be committed to the therapy, Messerlian said. In Janssen Compass, a care navigator will help set expectations, educate each patient on how to manage potential obstacles and support them in developing a care plan to communicate with doctors.

In return, J&J is getting valuable insights. Janssen Compass allows the company to understand and analyze which patients will be most likely to drop off, and what are some interventions we can [use to] predict and prevent these types of patient drop-offs, Messerlian said.

Beyond patient support, J&J is also teaming up with healthcare facilities and specialty networks to help train doctors, especially in the community setting. The goal of such education is, as Messerlian put it, about bending the quality-of-life curve.

RELATED:Pharmas' return on $5B spent yearly on patient support programs? Only 3% are using them: survey

Working with its care partners, J&J is collecting and analyzing data to map out how various patients move through the treatment process, aiming to improve outcomes along the way.

It comes down to understanding, what are the inputs of this care process, what are the decisions along the process, and can you standardize to that, Messerlian said. [With] a standard set, you can then roll that out in partnership with other practices to ultimately elevate the standard of care.

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Invitae, UCL and the Francis Crick Institute Announce New Data From TRACERx Research Collaboration at the 2021 International Society of Liquid Biopsy…

Tuesday, October 26th, 2021

-- Study uses Invitae Personalized Cancer Monitoring (PCM) liquid biopsy to accurately profile tumors and enhance cancer circulating tumor DNA-based minimal residual disease (MRD) lead times; highlights promise for personalized cancer care --

Published: Oct. 22, 2021 at 7:00 AM CDT

SAN FRANCISCO, Oct. 22, 2021 /PRNewswire/ -- Invitae (NYSE: NVTA), University College London (UCL), and the Francis Crick Institute today announced new data from their TRACERx lung cancer research collaboration funded by Cancer Research UK and sponsored by UCL. The data, presented by Professor Charles Swanton of UCL and the Francis Crick Institute at the International Society of Liquid Biopsy (ISLB) Congress,further validate the value of liquid biopsy as a less invasive and more comprehensive approach to guiding personalized cancer treatment in the absence of detectable disease by clinical imaging. Previously reported findings from the TRACERx cohort found that monitoring for cancer circulating tumor DNA (ctDNA) based minimal residual disease (MRD) detected relapse of non-small cell lung cancer (NSCLC) up to three years earlier than standard of care imaging surveillance in some instances.1

The study used a new blood-based informatic tool called ECLIPSE (Extraction of CLonality from LIquid bioPSiEs) with an earlier iteration of the Invitae Personalized Cancer Monitoring (PCM) liquid biopsy assay to analyze plasma samples of patients in the TRACERx study.With this approach, data demonstrated multiplex-anchored PCR sequencing of the plasma samples enhanced MRD lead times relative to standard of care surveillance scanning and allowed holistic sampling of clonal dynamics, or tumor heterogeneity, with prognostic implications for disease progression.

"Tumours are highly heterogeneous and standard biopsies can miss important tumor traits. Our findings from applying our novel ECLIPSE software with Invitae's multiplex-anchored PCR technology, which powers the Invitae PCM assay, are promising. They underscore the tremendous potential of PCM for providing representative tumor sampling throughout the disease course, and most importantly at an early stage or at early recurrence in the absence of disease on standard imaging, which may in the future inform clinical trial stratification and the best treatment plans for patients," said Professor Charles Swanton, Cancer Research UK's Chief Clinician and a 2021 ISLB award recipient for outstanding scientific contribution in liquid biopsy. "Better understanding the true pathology of a patient's tumor, including driver and passenger clonal mutations, and identifying MRD earlier, are key to unlocking personalized cancer care and changing the paradigm of cancer drug development towards earlier intervention in the adjuvant setting where cures are more readily achievable."

Invitae's PCM is a pan-cancer, tumor-informed liquid biopsy assay that uses next-generation sequencing powered by Anchored Multiplex PCR (AMP) to monitor MRD with high sensitivity at low variant allele fractions. The service employs a combination of a tumor profile, blood tests and personalized assays based on a patient's tumor with the goal of earlier detection of cancer recurrence through ctDNA before it is detectable by imaging or other conventional methods. ECLIPSE, developed by the Cancer Research UK TRACERx team at UCL and the Francis Crick Institute, uses a standardized algorithm that helps resolve tumor tissue-based sample bias. Coupling Invitae's PCM assay with ECLIPSE, the researchers analyzed 972 longitudinal plasma samples from 136 TNM I-III NSCLC patients in TRACERx who had undergone multiregion whole exome sequencing of primary tumor and relapse tissue and had 364 surveillance scans. Seventy-five of these patients experienced a recurrence of their surgically resected disease.

The researchers concluded that multiplex-anchored PCR with trinucleotide specific background modelsimproves NSCLC relapse detectioncompared to standard of care clinical follow up. Using ECLIPSE, plasma samples of less than 1% purity can be used to accurately profile the clonal structure of tumors at diagnosis, during treatment and at relapse, which impacts patient outcome and has the potential to guide personalized medicine.

"Determining the best treatment plan for a cancer patient depends on several factors, including the results of current disease monitoring. Unfortunately, traditional monitoring methods such as imaging and tissue biopsy are insensitive when it comes to adequately representing a tumor or detecting relapse early in a patient's treatment cycle," saidRobert Nussbaum, M.D., chief medical officer of Invitae. "These findings further validate the role of PCM in determining a therapy's effectiveness and identifying relapses more quickly, both of which are essential to optimizing personalized treatment plans."

PCM and other liquid biopsy approaches for monitoring MRD have the potential to become a mainstay in personalized oncology. PCM could be applied in a variety of ways to help improve patient care and prolong survival outcomes, including monitoring for recurrence, monitoring a patient's response to therapy to inform treatment decisions, and improving clinical trial designs to help get new therapies to market sooner.

About TRACERx Study

TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analysing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.

About Cancer Research UK

For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visitwww.cancerresearchuk.org. Follow us on TwitterandFacebook.

About UCL (University College London) London's Global University

UCL is a diverse community with the freedom to challenge and think differently. Our community of more than 41,500 students from 150 countries and over 12,500 staff pursues academic excellence, breaks boundaries and makes a positive impact on real world problems. We are consistently ranked among the top 10 universities in the world and are one of only a handful of institutions rated as having the strongest academic reputation and the broadest research impact. We have a progressive and integrated approach to our teaching and research championing innovation, creativity and cross-disciplinary working. We teach our students how to think, not what to think, and see them as partners, collaborators and contributors. For almost 200 years, we are proud to have opened higher education to students from a wide range of backgrounds and to change the way we create and share knowledge. We were the first in England to welcome women to university education and that courageous attitude and disruptive spirit is still alive today. We are UCL.

About The Francis Crick Institute

The Francis Crick Institute is a biomedical discovery institute dedicated to understanding the fundamental biology underlying health and disease. Its work is helping to understand why disease develops and to translate discoveries into new ways to prevent, diagnose and treat illnesses such as cancer, heart disease, stroke, infections, and neurodegenerative diseases.

An independent organisation, its founding partners are the Medical Research Council (MRC), Cancer Research UK, Wellcome, UCL (University College London), Imperial College London and King's College London.

The Crick was formed in 2015, and in 2016 it moved into a brand new state-of-the-art building in central London which brings together 1500 scientists and support staff working collaboratively across disciplines, making it the biggest biomedical research facility under a single roof in Europe. http://crick.ac.uk/

About Invitae

Invitae Corporation (NYSE: NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website at invitae.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the study results and implications thereof; the company's beliefs regarding the study, including that it highlights the promise of personalized care and further validates the value of liquid biopsy and the potential benefits of the company's PCM assay; and statements relating to the potential applications of PCM. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; regulatory approval and market acceptance of PCM; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Contact: pr@invitae.com (628) 213-3283

1Abbosh Chris et al, Abstract CT023: Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study. Cancer Res August 15 2020 (80) (16 Supplement) CT023; DOI: 10.1158/1538-7445.AM2020-CT023

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How mindfulness-based stress reduction can improve quality of life in people with autism – ASU News Now

Tuesday, October 26th, 2021

October 22, 2021

About 12 years ago in Russia, wildlife conservation biologist Adam Stein was involved with projects on the Oriental stork.

A Russian colleague had been working on how to save the species then numbering only about 3,000 throughout its entire habitat from Siberia down into Manchuria, Korea and Japan. Stein observed firsthand the experience of working across borders and languages, and dealing with capacity issues and proprietary data to save a species that now numbers about 7,000.

Now, during a time where many things have changed, Stein has taken the international conservation biology class offered at Arizona State Universitys College of Integrative Sciences and Arts from classroom lectures to weekly meetings with researchers from Siberia to the Solomon Islands, Nicaragua and Tanzania.

It's been a great opportunity for the students just to really see how these different cultures work, to get conversations with those people on the ground, Stein said.

The combination of being isolated with new meeting technology offered a fresh opportunity to recast the class.

We can't necessarily go to the Solomons for the week or to Tanzania for the week, Stein said. And we can't cram all that into the semester. And so what better way than to just take this technology and say, this is the best way to teach this class instead of having a Westerner sit up here and talk about, you know, this is how it goes.

The course has been offered at ASU for some time, but its the first time Stein has taught it. Students learn about wildlife around the world, including biogeography, biodiversity, conservation topics and the complexity of conserving wildlife in both developed and developing nations.

Stein has traveled around the world as a conservation biologist and met scores of people in the field.

I've met a lot of different individuals at different levels of conservation and have been able to see ecosystems and conservation issues firsthand, he said. And when I was offered to teach this course, I said, this is a great opportunity for me to touch base with all of these colleagues from around the world. And instead of me telling the story that I've witnessed, have them firsthand tell these stories and tie it into an overall picture of how conservation works on an international level.

Conservation biology is a rigorous science that looks at what is needed to maintain populations. What is the amount of species needed for enough genetic variability? How do we maintain that population? How do we keep that minimal viable population going? What's the dynamic area that's needed to support those organisms working within the matrix of human interactions? The international component talks about why its a global problem.

Stein kicked off the semester with locals who live on the edge of one of the last large wildernesses in Central America in Nicaragua, a 2,500-square-kilometer ecosystem home to the last big populations of jaguars and other large mammals. Its vastly important for the connectivity of wildlife species that make their way from Mexico through to South America. Without that linkage, two continents are broken apart.

It has ramifications beyond just its own borders about the connectivity of these ecosystems, and it's under threat, Stein said. We see that it's being undermined in the last five to 10 years. It's being degraded by deforestation, by intruders into this environment. And Nicaragua is a very poor country and doesn't invest a lot of resources into this conservation."

Initially people might assume these intruders are impoverished residents looking for opportunities, Stein said but in fact, there are reports that the government is the driver behind it, seizing land and giving concessions to companies such as large cattle operations.

"What I think it did for the students was it kind of opened their eyes to the government may be the problem here, and why can't the people do something about that?" he said.

"These are the questions that are generated by the students ... and the feedback I've heard has really, you know, shown the complicated issues that come with that."

Top photo of Nicaragua courtesy of Pixabay.com

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Philips brings clarity to every moment of cancer care with new patient-centered innovations at ASTRO 2021 – GlobeNewswire

Tuesday, October 26th, 2021

October 21, 2021

Amsterdam, the Netherlands and Chicago, USA Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced new innovations that will help improve cancer care across the patient journey at the American Society for Radiation Oncology (ASTRO) annual meeting (Chicago, USA, 24-27 October). During the event, Philips will debut its Multimodality RT Simulation Workspace, a new precision medicine application that provides a vendor-agnostic single space for simulation, multimodality image fusion and contouring. New MR and CT imaging systems tailored for the needs of radiation therapy will also be showcased, delivering breakthroughs in imaging and treatment planning. Philips will also highlight its deepened strategic partnership with Elekta to support the ambition of providing clear care pathways and predictable outcomes for every cancer patient.

Today, cancer care is a long, complex journey through various stages, settings, and providers, putting a significant burden on both patients and clinicians. The number of new cancer cases is expected to rise by about 70% over the next two decades [1]. At the same time, oncology care is transforming, driven by an increasingly precise diagnosis of each tumor, and a continuously expanding range of therapy options. To fully capitalize on these challenges and opportunities, healthcare providers require integrated solutions throughout the entire cancer care pathway, from diagnosis to treatment and follow-up.

Enhanced through strategic partnerships, our end-to-end oncology solutions span the patient pathway and the multidisciplinary specialties, integrating data and enabling collaboration, all with the aim of improving patient and staff satisfaction and outcomes, said Ardie Ermers, General Manager Oncology Solutions at Philips. At this years ASTRO meeting were highlighting how were connecting clinical and operational teams with the information they need to optimize and personalize cancer care.

Bringing clarity in therapy planning closer to the point of care with Multimodality RT Simulation WorkspaceWith images and data often siloed in different systems, the complexity of image fusion and contouring can lengthen patient time to treatment. Integrating seamlessly into the simulation workflow, Multimodality RT Simulation Workspace, a new precision medicine application, is designed to help physicians define tumor volume and surrounding organs-at-risk through a versatile multimodality image platform which connects to both Philips and non-Philips imaging devices or a Picture Archiving and Communication System (PACS) to access image datasets such as CT, MR, PET, Spectral CT and Cone Beam CT. These capabilities provide better access to a task-centered, vendor neutral solution that efficiently utilizes all available images and data in one central location.

Innovations in MR and CT simulation deliver advances in imaging and treatment planningWith the companys strong track record of bringing continuous innovations to expand the role of MRI in radiation therapy, the next-generation Philips MR Ingenia RT XD MR simulation platform has been designed around the needs of radiation oncology, combining ease-of-use, streamlined integration and versatility. The platform can be easily adapted for different procedures, including external beam radiation therapy (EBRT), proton therapy and brachytherapy planning. The new Couch Top RT XD with Unity indexing further extends the compatibility between the Philips MR Ingenia RT XD and Elekta Unity, supporting greater consistency in both image quality and imaging and positioning workflows that enhance reproducibility, help accelerate learning curves and drive continuity across the care path.

The recently-introduced Spectral CT 7500 system delivers high quality spectral images for every patient on every scan 100% of the time to help improve disease characterization, and reduce rescans and follow-ups, all at the same dose levels as conventional scans. Unlocking the clinical value of dual-energy CT for radiation oncology applications, Spectral CT allows for optimization of lesions that may represent cancer. By capturing additional information such as electron density and effective atomic number, Spectral CT enables physicians to quantify physiological processes such as perfusion and ventilation, enhancing treatment planning.

Philips is collaborating with MIM Software to integrate its Contour ProtgAI next-generation deep learning segmentation on its CT Big Bore RT platform, providing automatically segmented Organ at Risk segmentation immediately after the simulation exam [2].

Further expansion of precision medicine application portfolioAlso being introduced at ASTRO, Multidisciplinary Team Orchestrator virtually connects and securely integrates multi-disciplinary teams and data across the patient cancer journey. Together with Multimodality RT Simulation Workspace, applications already available from Philips that advance precision oncology through integrated care, pathway orchestration, and clinical decision support, include:

Partnering to benefit patients throughout the care pathwayIn June, Philips and Elekta announced that the two healthcare leaders would deepen their strategic partnership in precise and individualized oncology care. The strengthened strategic partnership intends to further deliver an excellent experience in diagnosis and adaptive, personalized treatments for clinicians, shorter treatment times and precise therapy for patients, and lowered costs of care for healthcare providers. As part of the partnership, Philips will develop seamless integration between its precision medicine applications and Elektas MOSAIQ Plaza integrated radiotherapy software suite, enhancing end-to-end decision making and treatment implementation.

For more information about Philips presence at ASTRO 2021 follow @PhilipsLiveFrom for updates throughout the event.

[1] WHO International Agency for Research on Cancer https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf%5B2%5D Big Bore RT with Contour ProtgAI is only available in the USAMultimodality RT Simulation Workspace is a new feature of the TumorLoc module, part of Pinnacle RTPS. Both TumorLoc and Pinnacle are FDA cleared

For further information, please contact:

Kathy OReillyPhilips Global Press OfficeTel.: +1 978 221 8919E-mail: kathy.oreilly@philips.com

Mark GrovesPhilips Global Press OfficeTel.: +31 631 639 916Email: mark.groves@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at http://www.philips.com/newscenter.

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UK Pharmacovigilance Market | Rising Usage of Medical Information Systems Drive the Industry Growth – BioSpace

Tuesday, October 26th, 2021

The COVID-19 outbreak and subsequent lockdowns and pandemic situation changed the way of handling clinical trials. This greatly affected the U. K. pharmacovigilance market. Furthermore, rising externalization as well as outsourcing of clinical trials by several biotechnological as well as pharmaceutical companies is boosting the demand in U. K. pharmacovigilance market. Some other factors driving the growth in the U. K. pharmacovigilance market include presence of regulatory mandates prescribing ideal trial conduct as well as pointing out strict post-marketing vigilance.

The study on the U. K. pharmacovigilance market offers a critical assessment of key growth dynamics, technology trends, regulatory frameworks prevailing in key regional markets, and recent investment trends among prominent stakeholders. The research provides a detailed insight into the share and size of various segments in the U. K. pharmacovigilance market. The report also estimates their projected valuation by the end of 2031, and regulations that may disrupt or hold game-changing potential in the near future.

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The U.K. Pharmacovigilance Market: Major Trends and Drivers

Increasing incidence of adverse drug reactions or ADRs caused by drug abuse as well as rising prevalence of severe diseases that require combination drug therapies are two of the major drivers for the products in the U. K. pharmacovigilance market. Furthermore, rising efforts in increasing the production of essential drugs as well as presence of strict government norms and regulatory frameworks may fuel the growth in the U. K. pharmacovigilance market in coming years. Similarly, advancements in creation of ADR databases as well as rising usage of medical information systems are also expected to bolster the upward trajectory of the U. K. pharmacovigilance market in near future.

The government of the United Kingdom has integrated several new and cutting edge technologies such as virtual trial technology, to supplement the processing of negative events pertaining to the COVID-19 vaccines. Integration of virtual trial technology is vaccine development as well as in securing full service COVID trials as well as studies is also bolstering the development in U. K. pharmacovigilance market. Furthermore, rising drug development efforts in the field such as personalized medicine, orphan drugs, adaptive trial designs, biosimilars, and companion diagnostics is also expected to foster the demand in the U. K. pharmacovigilance market in near future.

The U.K. Pharmacovigilance Market: Key Players and Manufacturers

The research report features a thorough evaluation of the competitive landscape in U. K. pharmacovigilance market. It includes information about the major players in the market. The business intelligence report highlights their product range, production volume, market share and size, profile, key competitors, and regions of operations. Through assessment of historic data about pricing and profit margins, readers can gauge potential opportunities in various segments in the U. K. pharmacovigilance market.

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Some of the key and leading players as well as manufacturers operating within the U. K. pharmacovigilance market may include Accenture, IBM Corporation, ICON PLC, IQVIA, PAREXEL International Corporation, Cognizant, ArisGlobal, Capgemini, TAKE Solutions Ltd., and BioClinica, among others. The U. K. pharmacovigilance market is considered to be somewhat fragmented owing to the presence of significant number of players operating within the industry. Some of the key strategies adopted by the players in the U. K. pharmacovigilance market for expansion include constant product development, partnerships, alliances, and collaborations, among others.

For example, Ashfield Pharmacovigilance Inc., a United States based subsidiary of UDG Healthcare PLC, was acquired by the Ergomed PLC for complete cash consideration of US$ 10 million. This acquisition is aimed at supplementing the development of Ergomed PLLCs combined PV as well as CRO business all over the world. This will also aid them in establishing presence and offering avenues for potential growth in the U. K. pharmacovigilance market in North America.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Oxford’s Genomics Pushing the Boundaries of Personalized Medicine – BioSpace

Sunday, April 4th, 2021

Its something of the holy grailrun whole genome sequencing on a sample of a persons blood and identify their risk for disease, all quickly and affordably. Oxford, Englands Genomics, founded in 2014 out of Oxford University by Sir Peter Donnelly, may be getting close.

The company is launching a trial in a new NHS pilot project with 1,000 volunteers, focusing on heart disease. It also plans to begin a similar trial in Stanford Hospitals in California with about 5,000 patients between the ages of 40 and 60 starting this summer.

If effective, it would be able to help people in their 40s or 50s determine the likelihood of their developing heart disease. This would allow physicians to help patients make the appropriate lifestyle changes and begin taking necessary drugs, such as statins.

The volunteers in the studies will donate a blood sample and the Genomics technology platform leverages an algorithm to analyze their genetic patterns. Some of those patterns have been associated with an increased risk of heart attack later in life, even if they currently have no symptoms. They will then be given a personal polygenic risk score (PRS), which can be used alongside a clinical risk prediction tool that the NHS is already using, that takes into consideration things like BMI and cholesterol levels.

This is yet another example of the NHS leading the world with this trial, Donnelly told the Evening Standard. This is cutting edge [tech]. It is about getting it into healthcare now and increasing focus on prevention.

Although these studies are focusing on heart disease, the companys technology is also focused on a range of genetic patterns associated with other diseases, such as cancer and multiple sclerosis. Donnelly even thinks its possible that eventually it will be used to evaluate people in their 20s and 30s for diseases that are more commonly developed earlier, such as auto-immune diseases.

Of course, some people may not want to know.

I understand why someone would be a bit worried, Donnelly said. It is important to say that these are just risk factors. If you have a high PRS score for heart disease, you are around four to five times more likely to get it. Its not that genetics determine the outcome, it is a risk factor. In all cases, there are things you can do [to help prevent disease]. You can be more vigilant, you can have medical interventions. That is important to understand.

On March 1, Genomics completed a $30 million funding round, with investments from Foresite Capital and F-Prime Capital, joined by existing backers Oxford Sciences Innovation and Lansdowne Partners. The company plans to use the monies to expand its work building its health platform.

Jim Tananbaum, chief executive officer of Foresite Capital, stated, Genomics plc plays a key role in transforming how we understand and deliver precision medicine at scale. We are excited to support this talented management team as the company embarks on its next growth phase.

Stephen Knight, president and managing partner of F-Prime Capital, noted, The convergence of data sciences with life sciences is one of the most exciting areas in healthcare today and we see Genomics plc as a clear leader in that field. The companys proprietary research platform powered by a large dataset of genotypic and phenotypic information, combined with the leading statistical genomics team in the world, delivers unique insights in the discovery of new therapeutic targets as well as key advancements in preventative healthcare.

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Oxford's Genomics Pushing the Boundaries of Personalized Medicine - BioSpace

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Personalized medicine is the future of health care for troops, advocates say – Military Times

Sunday, April 4th, 2021

Master Sgt. Geoff Dardia was nearly a decade into his Special Forces career when he says he hit a wall. He was struggling both mentally and physically to keep doing his job and couldnt explain why.

All of the sudden, I was just a shell of a person like everything you hear about feeling like youre dragging a dead body and losing your zest for life, Dardia said.

Plagued by severe migraines, fatigue and issues with his balance and vision, Dardia, now 44, sought help.

His superiors told him to visit a military behavioral health specialist and be treated for PTSD or depression, but Dardia was convinced his ailments were more than just psychological. So, he did what any good Green Beret would do and applied his training to research, analyze and attack the problem condition.

Following the steps of the military decision-making process, Dardia learned everything he could about his operational environment and the various ways it could affect him.

Traumatic brain injuries, toxic exposure to heavy metals and carcinogens, traumatic stress and sleep deprivation are unfortunately common occurrences for members of the special operations community.

After identifying the underlying causes for his symptoms, Dardia began planning a course of responsive action. The process was so simple, straightforward, and guided by existing military doctrine that it led him to question the Armys current approach to health care.

I was like, This is so easy. Why wouldnt we do this with health and wellness and medicine? Dardia said.

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At its core, thats what functional medicine is all about: finding and treating underlying causes of illness or pain. The Institute for Functional Medicine defines it as a systems biology-based approach that focuses on identifying and addressing the root cause of disease.

Also referred to as personalized, performance or lifestyle medicine, the approach is grounded in a philosophy of caring for a whole person made up of interconnected parts.

Its what Dardia and health care professionals spoke about on March 25 at the Warfighter Health Symposium in Tampa, Florida. Hosted by non-profits Task Force Dagger Special Operations Foundation and HunterSeven, the event served to informally educate active duty servicemembers, medical providers and veterans about the current issues and solutions in military health care. There were 50 people the maximum allowed under COVID-19 restrictions who attended.

After personally experiencing the difficulty of receiving holistic treatment, Dardia began making the changes he wanted to see. In 2012, when TFDSOF helped him through his personal health struggles, Dardia decided to give back by founding the organizations Health Initiative Program.

The program provides pathways and funding assistance for members of the military to seek treatment from outside health care providers and institutions in the field of personalized medicine.

Partnering with organizations like the Cleveland Clinic Center for Functional Medicine and becoming involved with active-duty health initiatives in the 3rd Special Forces Group, Dardia has been raising awareness of the power of preventative and holistic medicine for the better part of a decade now.

According to Dardia, the militarys current approach to health care is too reactive. Service members are treated for cancer or suicidal ideations or organ failures when such issues could have been prevented with proper countermeasures and education about their causes years earlier.

Just because you have mental health symptoms, doesnt mean mental illness is the cause, said Dr. Carrie Elk, founder of the Elk Institute for Psychological Health & Performance, a non-profit established to provide mental health education and treatment to servicemembers.

Elk has worked with SOCOM and the SOF community to treat operators for the underlying cause of post-traumatic stress disorder since 2010, when she first spoke at the Joint Special Operations Forces Senior Enlisted Academy on how PTSD works. Her practice now reaches both operators and members of the general military community.

They were applying the same stuff they used for mental illness to PTSD, but the problem is just the way the information is stored, said Elk. The audience was stunned by Elks presentation, and special operations personnel began filling the waiting room of her practice.

In just two hours of therapy, the doctor says, shes able to correct the storage of a traumatic memory.

In traumatic situations, according to Elk, memories are stored as sensory experiences. When servicemembers return home from traumatic environments, triggers like smells and sounds can bring them right back to places of anger, agitation, depression and anxiety.

Health care providers treating symptoms of depression and anxiety with prescription medications ignore the real problems at hand, according to Elk.

Were putting a Band-Aid on a bullet hole or at least trying to, said Elk. Youre not fixing the cause, youre just managing symptoms when you dont have to.

Functional approaches like Elks are growing in popularity. The Army adopted a section on holistic health in its updated physical fitness doctrine in September 2020 a combination of its previous initiatives like the Performance Triad and Army Wellness Centers.

The Holistic Health and Fitness program, or H2F, is the framework to encompass all aspects of human performance to include physical, sleep, nutritional, spiritual, and mental fitness, said Maj. Gen. Lonnie G. Hibbard, commander of the U.S. Army Center for Initial Military Training in a press release.

The Department of Veterans Affairs has introduced similar programming aimed at addressing the causes of illness rather than symptoms.

The biggest thing is awareness and education and advocacy, said Dardia. The earlier servicemembers can learn to prevent toxic exposure and recover from stress and sleep deprivation, the healthier theyll be in the long term.

Now the operations sergeant for 3SFGs Human Performance and Wellness program and the Medical Education Transition Advocacy and Assistance program, Dardia is focused on bringing personalized medicine programming to other Special Forces groups, veterans and units across the military.

At Thursdays symposium, Dardia spoke on functional, performance medicine alongside health care professionals from the HunterSeven Foundation.

Members of SOCOMs medical staff attended the three-hour conference in personal capacity, but SOCOM did not officially participate, according to a spokesperson.

Our main focus is research and education, given that we are medical experts with advanced clinical licenses and degrees, said Chelsea Poisson, an Army veteran, emergency nurse and clinical researcher with HunterSeven. The attendees were extremely receptive, I had many questions from members across all communities on resources and what to do next.

In addition to working with members of Congress to give suggestions and solutions to military health care legislature, HunterSeven provides TFDSOF with access to its extensive research on veterans health care issues.

HunterSeven is working on legislation and research to get laws passed that provide our people with better access to health care quicker, said Dardia. Theyre optimizing systems already in place, whether thats in the DoD or at the VA.

As functional, lifestyle-based medicine is adopted across the military, Dardia hopes to work himself out of a job. In years to come, the Green Beret hopes to begin correcting the problem of reactive health care in the civilian population, educating young people about disease prevention and holistic medicine.

We want to advocate this not just for military personnel and veterans; this applies to everybody, said Dardia. This isnt unique to the military. Cancer and suicide are rampant in the civilian population as well, and for the same reasons.

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Precigen CEO Envisions a Transformative 2021 with Precision Medicine Therapy – BioSpace

Sunday, April 4th, 2021

Precigen Chief Executive Officer Helen Sabzevari pictured above.

The year 2020 and the COVID-19 pandemic created a number of challenges for individuals and companies. Despitethese hurdles, Maryland-based Precigen still managed to achieve its clinical milestones in oncology.

The company is advancing its UltraCAR-T cell therapy approach to treating cancer that Chief Executive Officer Helen Sabzevari believes will be transformative to the personalized cell therapy landscape for cancer patients.

This is what precision medicine in the twenty-first century should look like, Sabzevari told BioSpace in an interview.

Sabzevari joined Precigen in 2017after undergoing a rebranding effort that included a name change from Intrexon Corporation, as well as the divestiture of non-healthcare assets, such as AgBiotech and Intrexon Produce Holdings. The company now focuses on the development of next-generation gene and cell therapies that have potential to change the treatment paradigm in immuno-oncology, autoimmune disorders and infectious diseases.

While there are multiple companies pursuing programs of these types, Sabzevari said Precigen can differentiate itself through a unique precision medicine approach that could simultaneously impact different types of genetic expressions on cancer cells, both hematological and solid tumors. Additionally, Precigen believes its UltraCAR-T immunotherapies can be developed with fewer toxicity issues and manufactured at a lower cost than currently available CAR-T treatments.

She added the company has the most differentiated platform in cell and gene therapy compared to other companies in the space.

The company is developing two UltraCAR-T platforms. The first, PRGN-3005 UltraCAR-T, is a first-in-class investigational therapy currently being assessed in a Phase I/Ibclinical study for the treatment of advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer.

In December, Precigen reported preliminary data from the study that showed a favorable safety profile with no dose-limiting toxicities (DLTs), neurotoxicity or cytokine release syndromes. What may be most important of all, Sabzevari said the study showed the UltraCAR-T treatment generated expansion and persistence after low dose IP infusion without lymphodepletion.

Precigen intends to begin a dose expansion of this study in the second half of the year. For the first time, Sabzevari said, they were able to show clinical efficacy in a solid tumor. Approximately 50% of patients showed a decrease in tumor lesions.

Precigen is also developing PRGN-3006 UltraCAR-T, a first-in-class investigational therapy currently under clinical evaluation in a Phase I/Ibstudyfor the treatment of patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS).

Preliminary Phase I data reported in December showed a favorable safety profile with no DLTs or neurotoxicity. Encouraging expansion and persistence of PRGN-3006 UltraCAR-T was observed in both lymphodepletion and non-lymphodepletion cohorts and across all dose levels. PRGN-3006 treatment indicated clinical activity as evidenced by reduction in AML tumor blast levels, the company said. Data from the PRGN-3006 study also revealed that UltraCAR-T cells persisted for more than seven months after a very low dose of 24 million total UltraCAR-T cells in a patient. Sabzevari said this highlights the difference between Precigens UltraCAR-Ts and other CAR-T programs, which introduce hundreds of millions of CARs in to patients during an infusion. Those CARs also have a shorter life than the Precigen assets, which means they can have a sustainable impact on cancer.

Following the revelation of the preliminary data, the U.S. Food and Drug Administration awarded PRGN-3006 with Orphan Drug Designation for AML.

While CAR-T therapies are not yet considered front-line defenses in cancer, Sabzevari predicted that cell and gene therapies will eventually move to first-line options.

Checkpoint inhibitors have become frontline therapies and thats the vision for CAR-T and cell therapies, she said.

Sabzevari likened the possibilities of Precigens UltraCAR-T therapies to antibiotics. If a doctor prescribes one and it does not produce the desired therapeutic effect, there will be another type available from the companys library that could treat the cancer.

If one target, for whatever reason isnt sufficient, you can switch overnight to change it with another. In our vision, a patient can come in and an oncologist could identify the indication of the cancer through screening, order a treatment from our UltraCar-T library and get it done, infuse the patient, Sabzevari said.

Because of the potential Precigens UltraCAR-T program has in oncology, Sabzevari believes the companys stock is significantly undervalued. In January, Precigenraised about $130 million. She believes the stock could go much higher and noted that Precigens market cap has tripled in the past year.

2021 promises to be another transformative year for our company with important data readouts and trial initiations anticipated for our key programs. We have a very good stretch of growth in front of us, Sabzevari said.

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Precigen CEO Envisions a Transformative 2021 with Precision Medicine Therapy - BioSpace

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What Are the Evolving Opportunities for the Players in the Precision Medicine Market? The Courier – The Courier

Sunday, April 4th, 2021

According to P&S Intelligence, the precision medicine market generated $203.5 billion in 2019 and it is expected to reach $738.8 billion by 2030, progressing at a CAGR of 12.1% during the forecast period (20202030). This growth can be driven by the rising government support, escalating awareness regarding personalized treatments, rising number of approved personalized medications, increasing use of artificial intelligence (AI) in clinical trials related to precision medications, surging number of regulatory approvals, soaring cases of chronic and genetic diseases, and flourishing medical tourism industry.

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Governments across the globe are taking several initiatives to develop personalized treatment, thereby, playing a vital role in the precision medicine market growth. According to the World Economic Forum, Argentina introduced a Precision Medicine Initiative Grant, in 2017, to start the scientific procedures needed to introduce investigational precision medicine approaches into clinical practices. Similarly, the U.S. administration under its Personalized Medicine Coalition announced its plan, in July 2019, to bring down the costs of drugs in the country, to make them comparable with international rates.

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Globally, the North America held the largest share in 2019, and it is expected to continue its dominance during the forecast period. This is due to the rising incidence of lifestyle-associated and chronic diseases, like CVDs and diabetes, burgeoning healthcare spending, and increasing number of government initiatives in the form of awareness programs and funding for precision medicine. Whereas, the Asia-Pacific (APAC) market will register the highest growth in the forecast years, owing to the increasing healthcare expenditure, presence of players developing precision medicines, and growing awareness about these medicines.

Thus, the rising frequency of critical trials and the magnifying government support will propel the market growth in the coming years.

This study covers

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What Are the Evolving Opportunities for the Players in the Precision Medicine Market? The Courier - The Courier

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Global Nanomaterials in Personalized Medicine Market 2021 by Manufacturers, Regions, Type and Application, Forecast to 2026 The Bisouv Network – The…

Sunday, April 4th, 2021

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How COVID-19 Will Help Denver Doctors Revolutionize Health Care – 5280 | The Denver Magazine

Sunday, April 4th, 2021

The COVID-19 pandemic has spawned collaborations in the Denver medical community that could help usher in a new golden age of medicine.

As the medical director of the Medical Intensive Care Unit at Denver Health, Dr. Ivor Douglas knows better than most how devastating a toll COVID-19 has taken. Weve lost 400,000 people, which is as many Americans as were lost in the Second World War, he says. (The number topped 520,000 in early March.) And weve done it in a year.

At the same time, Douglas understands that the unwelcome arrival of the novel coronavirus presents an opportunity to advance health care at an unprecedented rate. Absolutely its going to have long-term effects on human health and scientific discovery, Douglas says. He believes such rapid progress will occur because, well, hes seen it happen.

For about 20 years, Denver Health has been treating acute respiratory distress syndrome (ARDS)when fluid builds up in the tiny air sacs in the lungs, limiting the air they can holdby rotating ventilated patients from lying on their backs to the prone position, on their stomachs, for prolonged periods of time. Although the practice seems counterintuitive (doesnt breathing on your stomach appear constrictive?), Denver Health and other hospitals believed the practice increased oxygen levels while decreasing ventilator-induced lung injuries. But because there hadnt been a consensus on the effectiveness of the procedure, and its cumbersome to move intubated patients from supine to prone (three to six people are required), few hospitals regularly performed the technique.

Then COVID-19 began causing ARDS in severe cases. A number of studies promptly affirmed that proning such patients was a potentially life-saving decision. Further, research co-authored by Douglas lent credence to the safety of prolonged proning, in which patients remain in the position for days at a timemore than 20 in some cases. Once the pandemic is over, doctors around the world will use that information to treat people suffering from ARDS caused by bacterial pneumonia or viral influenza.

Similar COVID-19-spawned symbioses are not rare in Colorado. Rival health systems have banded together; thousands of patients have donated their DNA to scientific research; and specialists have rebuilt relationships with community doctors. While the trauma of COVID-19 will endure for years, its lessons could inspire benefits that last for generations.

When confusion reigned, Colorados largest health care providers united to chart a course through the pandemic.

When COVID-19 first arrived in the United States, the Centers for Disease Control and Prevention advised that Americans who werent sick didnt need to wear masks. Back then, even experts didnt understand the best ways to combat the disease. No one knew what was going on, says Dr. JP Valin, chief clinical officer at SCL Health, and that includes the health care providers of Colorados seven largest hospital networks. So we just said, Lets work on this together, Valin says. Physician executives of SCL Health, UCHealth, HealthOne, Centura Health, Denver Health, Boulder Community Health, and Banner Health began meeting virtually every weekday (and some weekends) to share data, discuss best practices, and manage the local distribution of personal protective equipment. By the end of July, the networks had collaboratively cared for 98 percent of the COVID-19-related hospitalizations in Colorado, and according to a study about the partnership published in the New England Journal of Medicine Catalyst, they boasted lower mortality, lengths of stay, and mechanical ventilation rates than the national averages. The collaboration later became a model for other states. We cant lose this after the fact, Valin says. This is something special, and weve done some really cool things.

How the rival networks worked together to ensure Coloradans got the care they needed during COVID-19.Back to Top

Perspective: Before the state instituted a COVID-19 tracking system, the partnership recognized early outbreaks. In March and April 2020, Banner began seeing a spike in positive tests in Weld County. When UCHealths hospitals in Weld reported a similar flare-up, they traced the surge to patients employer: the JBS USA Greeley beef plant. The group notified the state and county, which closed the plant (although a Denver Post story questioned the speed with which Weld responded).

Patient advocacy: Many hospitals and clinics in rural areas are affiliated with a larger providerbut some are not, and more than 60 percent of U.S. rural hospitals dont have a single ICU bed. So the collaborative worked through the Colorado Hospital Association to set up partnerships between rural hospitals and larger ones. The relationships included dispensing advice and accepting patients if they required emergency care. In 48 hours, Valin says, we were able to quell a lot of unease in rural areas.

Partnership: When hospitals were allowed to perform elective surgeries again in late April, SCL Health developed an algorithm to assess the health of incoming patients, and it shared this with the other systems. So every patient in the state of Colorado who was getting an elective procedure followed that exact same protocol, Valin says, rather than patients and doctors being confused [about precautions], or one hospital being safer than another. We wanted there to be confidence in all of us.

Peer support: An unexpected benefit of the partnership was the partnership itself. Physician executives are often isolated from their peers (both from other doctors and other C-suite suits). Through working with execs at other systems, they enjoyed support, workforce development ideas, and, in late August, a happy hour. We went to the Lowry Beer Garden, where its all these picnic tables, Valin says. There was a lot of trust generated very quickly because we could say, Were doing the right thing.

Childrens Hospital Colorados virtual town halls became a must-listen for a pediatric community that needed healing.Back to Top

For most of Childrens Hospital Colorados 113 years, community doctors tended to the facilitys patients. But as the economics of medicine changed, fewer physicians could afford to leave their practices to spend time at the hospital. Specialists became primary caregivers for inpatients. As a result, says Dr. David Brumbaugh, chief medical officer of Childrens, the hospitals relationship with the local pediatric community grew distant. Then COVID-19 struck. To help terrified local doctors who needed concrete answers, Childrens began hosting virtual town halls. Eventually, about 500 providers began tuning in on Thursday nights to listen to Childrens docs review the latest science. The fringe benefit: The town halls began to rebuild the connection between the hospital and community providers. We spoke with some of Childrens most avid weekly audience members to hear how.

Dr. David Brooks | Valley View Hospital, Glenwood SpringsWe reached out to Dr. Sean OLeary [a pediatric infectious disease specialist at Childrens] and he presented a Zoom conference [on virtual learning] to about 200 people in the Roaring Fork Valley. After that, pediatricians here helped re-establish in-person learning. Im not sure we would have progressed to that point without the town halls.

Dr. Sharisse Arnold Rehring | Kaiser Permanente, DenverI think I personally received several face shields from Childrens in the mail because I didnt have any, and I wasnt sure we were going to get them at Kaiser Permanente. We did, but Childrens Hospital didnt ask any questions except, Whats your address?

Dr. Sharon Sagel | Southeast Denver PediatricsAt the beginning you felt like this very small fish in this really big pond. How do we practice? We felt like we were reinventing the wheel every day. And then all of a sudden youre connected to a whole community of pediatricians who are all in the same situation. I dont know what the future will look like, but I think there is this sense that were all better when we work together.

Dr. Matt Dorighi | Cherry Creek PediatricsThese town halls have certainly created the environment where you have that confidence to do new things, like telehealth. Its such a great format for getting information on new ideas. Itll be interesting to see what topics they shift to after the pandemic. But its been a really efficient way to affect change in the community.

Thanks to the telehealth boom, UCHealths Biobank connected with more patients than ever.Back to Top

Personalized medicinealso called precision or individualized medicinetailors treatment to the specific indicators locked away in our unique DNA (and other molecules). The discipline could help improve the outcomes of pharmacology and even predict future diseases, such as breast cancer, based on cellular variances. In order for personalized medicine to work, however, it needs data. Lots of data. The more DNA collected, the more connections that can be made. The University of Colorado Anschutz Medical Campus Colorado Center for Personalized Medicine launched its Biobank in 2016 to become the repository of such info for UCHealth. It has since signed up more than 173,000 patientsbut owes its biggest surge in outreach to COVID-19.

Biobank asks UCHealth patients to participate through the systems online patient portal, My Health Connection. Before the pandemic, though, fewer than half of the networks patients used the portal to, say, schedule appointments. When the pandemic forced UCHealth to switch primarily to telehealth visits, patients were suddenly required to use their portalsand, thus, interact with the Biobank consent form. Weve actually been able to reach out to more potential volunteers for the Biobank than we ever could have done before, says Kathleen Barnes, director of the center. Which means a global pandemic could play a part in helping make Coloradans healthier than theyve ever been before.

The pandemic has felt particularly isolating to new parents. Maybe thats not such a bad thing.Back to Top

In August 2020, three months before she was due, Aliesa Pope-Hodge gave birth to her second son, Reign, at the Medical Center of Aurora. Weighing one pound and eight ounces, Reign was immediately placed on a ventilation system that filled his underdeveloped lungs with about 360 breaths per minute. He looked like he was vibrating, Pope-Hodge says. She estimates she got to see Reign for 20 seconds before hospital staff ushered the baby into an ambulance for the 10-mile trip to Presbyterian/St. Lukes (PSL) Medical Centers newborn intensive care unit (NICU), a Denver facility qualified to serve the most acutely ill infants.

There, Pope-Hodge and her husband, Diamond Taylor, donned masks, scrubbed and washed their hands, and were screened for fevers every time they visited Reign. Neither family nor friends were allowed to join them. But the restrictions were nothing compared to Pope-Hodges own feelings of separation. While practicing skin-to-skin contact to encourage bonding between mother and child, Reign would often cry. His heart rate and oxygen levels would dropa common occurrence for preemies experiencing touch for the first timeand alarms would shriek. I felt scared to touch him, Pope-Hodge says. Like I was going to hurt him. Maybe I stress him out? I felt detached from Reign for a very long time.

Detachment might be the official emotion of the pandemicparticularly for new parents. Even though nascent research suggests COVID-19 is uncommon in newborns, even among those with COVID-19-positive mothers, most local hospitals and birthing centers have restricted access during birth to the parents (or mom and one support person, such as a doula). Once a baby heads home, many doctors recommend limiting visitation there as well.

While this has thwarted the ambitions of cheek-pinching grandparents, seclusion hasnt been all bad for parents. You arent trying to cater to extended family and keep them updated, says Dr. Anna Zimmermann, a neonatologist at PSLs Rocky Mountain Hospital for Children. It pares the experience down to the parents and allows them to just get to know their baby.

Research on the benefits of pandemic-induced alone time is minimal so far, but one study did test its impact on familial bonds. During April 2020, 70 pregnant women in Ireland participated in a survey that sought to quantify the emotional effects of social distancing. Of those whose relationships with their partners had not deteriorated (only three had), 34.3 percent said theyd grown closer, 28.4 percent said they talked more, and 20.9 reported exercising together.

Pope-Hodge and Taylor finally brought a five-pound Reign home from PSL in November and promptly barred visitorsa difficult decree considering they live with Taylors mother. She held him on Christmas, Pope-Hodge says. Other than that, she hasnt touched him, which is really hard for her. She feels stripped of the gift of being a grandmother.

The isolation, though, has allowed Pope-Hodge to form a connection with Reign that she never imagined possible at the NICU. [Our eldest son] King had his grandma and his aunties, and everyone else around him that gave him love, Pope-Hodge says. With Reign, I feel proud that I am, with Diamond, the ones who are taking care of him. Everything that he gets is from me. I feel really proud of that.

Confronting the connections between public health and health care in our local communities.Back to Top

More than any other disease, COVID-19 has drawn attention to the tether between social ills and physical illness. The pandemic has just brought it to the fore in ways that, frankly, diabetes didnt, kidney disease didnt, [and] high blood pressure didnt, says Dr. Jandel Allen-Davis, the president and CEO of Craig Hospital in Englewood. To illustrate the connection between COVID-19 and public health issues, Colorado Health Institute (CHI), a Denver-based public health advocacy group, created a Social Distancing Index (SDI). CHI gave each Colorado census tract a score from one to 10 based on its comparison to other tracts in the state in three areas: population density, overcrowded housing, and proportion of essential workers. The index is the average of a tracts three scores. The higher the score, the more vulnerable a tracts population is to the spread of COVID-19and, as noted below, a range of social inequities.

College ViewMore than 40 percent of children under 18 in College View live in poverty, compared to 18 percent countywide.

WestwoodThe four U.S. census tracts that make up the Westwood neighborhood are all at least 80 percent populated by people of color.

HilltopThe wealthiest tract in Denver County is in the Hilltop neighborhood (median household income: $209,000). It is 86.6 percent white.

MontbelloThis tract in the Montbello neighborhood is one of the 25 USDA-identified food deserts in Denver County, all but six of which have SDIs above the county median of 3.1.

East ColfaxAccording to the U.S. Department of Housing and Urban Development, the percentage of low- to moderate-income residents (those who earn less than 80 percent of the metro area median income) in this part of East Colfax ranges from 61.2 to 87.7 percent.

WindsorThe per capita income in this tract is $26,341, about three-fifths of Denver Countys per capita of $43,770.

Hampden SouthIn the tract with the lowest SDI, only 4.7 percent of residents live below the poverty line, compared to 12.9 percent across the county.

Bioethicist Matthew Wynia speaks out about the mortal dilemmas of the pandemicand how COVID-19 could forever guide our moral compass.Back to Top

Who gets a ventilator and who doesnt? Should everyone be forced to wear a mask? Which demographics deserve to receive the COVID-19 vaccine first? These are the questions the pandemic forced Dr. Matthew Wynia and other bioethicists to wrestle with as they attempted to guide the health care system through a stark market of supply and demand. Director of the University of Colorado Anschutz Medical Campus Center for Bioethics and Humanities, Wynia not only advised on state policy, but also helped oversee the UCHealth triage team as it made critical decisions. In the early stages of the vaccine rollout in Colorado, 5280 spoke with Wynia to better understand how local hospitals came to some very difficult decisions.

5280: Were the choices about, say, who would get ICU beds already determined before COVID-19 came along?Matthew Wynia: Not exactly. We had a framework because weve had prior pandemicsthe 2009 H1N1 influenza pandemic had generated a lot of interest in these issues. But it hadnt been adapted to COVID. So that was the initial work. Pull that off the shelf, open it up, and start making adjustments based on COVID. Very early on, we were already seeing that there might be a problem with blood clotting. Well, thats not a normal problem with influenza. How does that affect the clinical decision-making?

How does it?Those factors get put into your risk calculation for how likely a patient is to die if theyre really sick with COVID. Because if you think theyre going to die no matter what, youre better off not allocating them scarce resources. Also, if you think they might be able to pull through if they dont get the scarce resource, you similarly dont want to put them on the scarce resource.

So if a patient has a history of blood clots, no ICU?Well, Id be careful about that, because there are about 30 things in our calculation.

This is a question typically reserved for supervillains, but how did you sleep at night?I am famous in my family for being able to sleep anytime, anywhere. Thats my superpower. In March, for the first time in my life, I was tossing and turning, because we thought Colorado was going to get hit hard, and we were going to end up implementing our triage teams. The thing [we] do not want is the bedside doctor to be the one deciding who receives these resources and who doesnt. Number one, your bedside doctor should be your advocate. And number two, the bedside doctor does not have great situational awareness of what else is going on around the hospital or the region.

Yeah, but that means you have to make that decision.Yes, but based on better information than that individual doctor has.

Because of all the tough choices doctors had to make during the pandemic, do you think bioethics has evolved?If we make good decisions that clearly prioritize equity, we could come out of this with greater levels of trust in the health care system among racial and ethnic minority populations that havent always trusted the health care systembecause they didnt have a lot of good reasons to trust the health care system. Watching leaders in health care really struggle with how to do this right, so that we dont disadvantage this community, that can be a cohesion-building experience.

Spencer Campbell writes features and edits service packages.

More:
How COVID-19 Will Help Denver Doctors Revolutionize Health Care - 5280 | The Denver Magazine

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Perspectum: High Liver Fat (Hepatic Steatosis) Linked to Increased Risk of Hospitalization in COVID-19 Patients With Obesity – Business Wire

Sunday, April 4th, 2021

OXFORD, England--(BUSINESS WIRE)--New research published this month in Frontiers in Medicine (Gastroenterology) reveals that individuals with both obesity and severe fatty liver are five times more likely to require hospitalization for the illness. The non-invasive liver imaging technology Perspectums LiverMultiScan was used to gather MRI scans for the study.

Obesity is often associated with fat accumulation in the liver, which can lead to liver disease, and emerging data suggests that patients with obesity are at an increased risk of becoming seriously ill with COVID-19. The World Obesity Federation summarizes recent reports suggesting in the US almost 50 percent of people hospitalized with COVID-19 were also affected by obesity. A new report from the CDC (Centers for Disease Control and Prevention, U.S.A.) indicates 78 percent of people who were hospitalized, placed on a ventilator or died from COVID-19 were overweight or obese.

The results of the imaging study, which explored whether having excess liver fat could influence severity of COVID-19 in obese individuals, showed that individuals with both obesity as well as fatty liver were five times more likely to require hospitalization for COVID-19. Notably, individuals with obesity and normal liver fat were not at increased risk of being hospitalized.

Some individuals with obesity have a normal level of liver fat and some non-obese individuals have high levels of liver fat. It is pertinent to establish whether pre-existing liver disease increases the risk of severe COVID-19 and how this relates to obesity, says Adriana Roca-Fernandez, first author and scientist at Perspectum, the company developing LiverMultiScan. Measurement of liver fat and detection of liver disease can be achieved using non-invasive imaging methods such as Perspectums well-validated, magnetic resonance imaging (MRI) technology to help identify patients with COVID-19 who are at increased risk of severe disease.

Understanding the contribution of liver fat to COVID-19 risk and outcomes is important for clinical understanding and management of COVID-19 and long COVID. The study, Hepatic Steatosis Rather Than Underlying Obesity Increases Risk of Infection and Hospitalization for COVID-19, Roca-Fernandez et al., 2021, also confirmed some previously reported risk factors for contracting COVID-19, such as being a male and having a lower socio-economic status. In addition, this study showed that the participants who had tested positive for COVID-19 were more likely to have higher liver fat. The MRI data were acquired before the COVID-19 pandemic by the UK Biobank, one of the largest biomedical databases in the world, and included 4,458 people who had later been tested for COVID-19.

According to Dr. Arun Sanyal, Virginia Commonwealth University, one of the authors of the study, The current study demonstrates pre-existing fatty liver disease is an independent risk factor for development of severe disease in those with COVID-19. This raises important questions about the role of hepatic steatosis and related liver injury as a disease modifying factor. These data highlight the public health relevance of NAFLD beyond cardiovascular, cancer and liver outcomes and provide a strong rationale for future studies to evaluate whether de-fatting the liver will reduce the likelihood of severe COVID-19 in affected individuals.

Determining all risk factors for increased severity of COVID-19 is crucial to help shape public policy measures to protect these high-risk individuals, such as social distancing, prioritization of people for vaccinations, and access to personalized medicine to guide clinical and lifestyle interventions, adds Roca- Fernandez.

Perspectum, a global medical technology company with offices in the U.K., the U.S. and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.

Excerpt from:
Perspectum: High Liver Fat (Hepatic Steatosis) Linked to Increased Risk of Hospitalization in COVID-19 Patients With Obesity - Business Wire

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Foundation Medicine Appoints Brian Alexander, M.D., M.P.H., as Chief Executive Officer – Business Wire

Sunday, April 4th, 2021

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced the appointment of Brian Alexander, M.D., M.P.H., as chief executive officer, effective April 6, 2021. Dr. Alexander previously served as Foundation Medicines chief medical officer since 2019 and brings with him years of experience as a radiation oncologist at Dana-Farber/Brigham and Womens Cancer Center and an Associate Professor at Harvard Medical School. He succeeds Cindy Perettie, who has taken on a new role within Roche Diagnostics.

Brian has been instrumental in leading Foundation Medicine in its mission to rapidly advance personalized medicine for cancer patients on a global scale, said Severin Schwan, CEO, Roche Group. As an oncologist, he is uniquely positioned to help the company become an ever-more-essential partner for patients, physicians, and the researchers developing new cancer medicines by providing them with the insights they need to support critical decisions.

Dr. Alexander joined Foundation Medicine as senior vice president of clinical development in September 2018 and was promoted to Chief Medical Officer the following year. He has directed Foundation Medicines decision insights strategy to help more oncologists, both in community and academic settings, determine the right treatment, at the right time, for each unique patient. Under his leadership, Foundation Medicines medical team has expanded its molecular tumor board program to include over 90 leading oncology centers globally, launched a cross-functional genomics and health disparities effort, and has developed hundreds of studies and publications to advance the clinical utility of genomic profiling.

I am proud to be part of a team that has delivered groundbreaking innovations catalyzed by our unparalleled insights into cancer genomics, said Dr. Alexander. I am grateful to Cindy for her leadership and mentorship during such a transformative time for the company, and Im excited to lead the next chapter for this remarkable organization as we work to enable better therapeutic decision making and help our pharmaceutical and biotech partners advance the breakthrough therapies of tomorrow.

Dr. Alexander was the founding director of the Program in Regulatory Science at the Dana-Farber Cancer Institute and the Harvard/MIT Center for Regulatory Science. He also co-founded the Global Coalition for Adaptive Research, a non-profit organization focused on clinical trial innovations to accelerate the discovery and development of cures for patients with rare and deadly diseases and served as chair of the FDA/Project Datasphere task force on external control arms. He previously co-authored a book on the interpretation of diagnostic tests for medical decision making. Dr. Alexander is an is an affiliated researcher at the MIT Laboratory for Financial Engineering and affiliated faculty of the Harvard Kennedy School Healthcare Policy Program. He was named to Boston Magazines Top Doctors List in 2019, 2020, and 2021.

Previously, Dr. Alexander served as a White House fellow and Special Assistant to the Secretary of Veterans Affairs, where he helped prepare the VA for the transition of administrations, worked to develop a public reporting system for quality, and served as a health policy advisor to the Secretary. Dr. Alexander organized the standup of the VAs Coordinating Council on National Health Reform and directed the activities of its multi-team Health Reform Working Group. He was also a member of the Institute of Medicines Committee on the Governance and Financing of Graduate Medical Education.

Dr. Alexander received his B.A. from Kalamazoo College, M.D. from the University of Michigan Medical School, and M.P.H. from the Harvard School of Public Health. He completed his training in radiation oncology at the Harvard Radiation Oncology Program.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine is a registered trademark of Foundation Medicine, Inc.

Source: Foundation Medicine

Excerpt from:
Foundation Medicine Appoints Brian Alexander, M.D., M.P.H., as Chief Executive Officer - Business Wire

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