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

March 9th, 2020 7:46 pm

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

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

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

A geographical market analysis is provided for all major segments.

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

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

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

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

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

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

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

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

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

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

March 9th, 2020 7:46 pm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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SOURCE Blue Shield of California

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

March 9th, 2020 7:46 pm

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

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

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

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

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

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

About Invicro

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

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

About Konica Minolta

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

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

March 9th, 2020 7:46 pm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Statement from The Pancreatic Cancer Action Network (Pancan) In Response to Alex Trebek’s Health Update – Pancreatic Cancer Action Network -…

March 9th, 2020 7:46 pm

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

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

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

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

PanCAN is hopeful that others will have similar outcomes.

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

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

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

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

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

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

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

March 9th, 2020 7:46 pm

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

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

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

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

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

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

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

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

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

March 9th, 2020 7:46 pm

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

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

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

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

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

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

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

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

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

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

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

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

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Keeping Up with the Change in Healthcare – CIOReview

March 9th, 2020 7:46 pm

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

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

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

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

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

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

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

What is your checklist for choosing technology vendors?

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

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

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

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

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

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

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

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

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

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

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

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

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

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Here’s My Top Stock to Buy in March – Motley Fool

March 9th, 2020 7:46 pm

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

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

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

Image source: Getty Images.

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

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

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

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

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

Image source: Getty Images.

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

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

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

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

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

Metric

First-Generation Cellular Therapy

Fate Therapeutics

Starting material

Cells derived from patient

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

Manufacturing process

Complex process required to make a single dose

Manufactured in batches (many doses from one production run)

Manufacturing time and cost

2-3 weeks and $450,000

Available off the shelf and less than $2,500

Engineering tools

Error-prone first-generation CRISPR/Cas9 tools

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

Cell type and dosing

CAR-T cells that can be dosed only once

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

Side effects

CRS and neurotoxicities

No cases of CRS reported in early studies of NK cells

Data source: Fate Therapeutics.

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

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

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

Drug Candidate, Cell Type

Indication

Last Update

FT516 (monotherapy), NK cell

Acute myeloid leukemia (AML)

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

FT516 (combination therapy), NK cell + monoclonal antibody

B-cell lymphoma

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

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

Advanced solid tumors in individuals who failed prior checkpoint inhibitor therapy

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

Data source: Fate Therapeutics Press releases.

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

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

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

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

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Global Personalized Medicine Market 2020 Industry Analysis, Trends, Size, Growth, Share, Strategies And Forecast To 2025 – NJ MMA News

March 9th, 2020 7:46 pm

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The report offers examination and growth of the market in these districts covering:North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

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Israeli Women Are Ahead In Biotech, But Don’t Have The Leadership Roles Just Yet | Health News – NoCamels – Israeli Innovation News

March 9th, 2020 7:46 pm

NoCamels Hezekiah Bird, Shuli Finley, Katie Hemmons, and Shana Jacobson contributed to this report.

Women make up 60-70 percent of roles in the biotechnology sector in Israel, a number that has not changed in almost a decade, according to the Nisha group, an Israeli recruitment and placement firm that specializes in biotech, biomed, fintech, and cleantech. But while women are ahead in the field, leading research teams and heading clinical trials, men still dominate upper management and executive roles, Nisha noted in a comprehensive report focused on women in biotech that was first published in 2012.

On Sunday International Womens Day 2020 Lizi Shoov London, Nishas partner and managing director of the companys Biotech division, confirmed to NoCamels that the numbers have not changed.

SEE ALSO: Whats The Best Advice You Got? 5 Questions With 10 Israeli Women Innovators.

Professor Rivka Carmi, former president of the Ben-Gurion University of the Negev the first and only woman to hold this position at a university says that despite the expectations that the field would mature and more women would take on executive roles, this hasnt been the case yet.

There are a lot of female researchers involved in biotech companies, she tells NoCamels, but there are not enough women in leadership roles or who have their own startups. In a time where high-tech and biotech go hand in hand, Carmi says, women only make up a third of the pie, not 50/50. The latest High-Tech Human Capital Report 2019 published by Start-Up Nation Central and the Israel Innovation Authority last month showed that the rate of women employed in the sector is at a standstill at about 30 percent, with just 22 percent for technology positions and 18 percent for tech management roles.

Carmi, who made it her mission during her 12 years as BGU president to increase cooperation between academia and industry she called it applied research set out to work with government authorities to push major biotech initiatives that would potentially make the future of women as biotech leaders a reality. These initiatives included the National Institute For Biotechnology In The Negev (NIBN), established as a company in November 2009 through a trilateral agreement between the Israeli government, founder Dr. Edgar de Picciotto, and Ben-Gurion University of the Negev, to become the first independent research entity established under the auspices of a university in Israel.

While she didnt specifically do so to put women in executive biotech positions, this was very unusual at the time, she says of NIBNs mission to bridge the gap between basic and applied research, while figuring out how to go about commercializing novel ideas and technologies developed by NIBN researchers.

I see how difficult it is for women to get leadership roles, so I am very vocal about it, she says. Women are in the minority in terms of having their own biotech startups. Many of them have to balance career and family. Not many of them want to make that concession. Its a lot of work building a startup and attracting investors.

Every woman will tell you that she encounters obstacles, Professor Carmi tells NoCamels.

Israels biotechnology and life sciences industry is a fast-growing sector, with at least 1,600 companies, including nearly 1,400 companies that were established since 2009 (thats 139 companies every year), according to the 2019 Israeli Life Sciences Report from the Israel Advanced Technology Industries (IATI.) The sector, which employs 83,000 people across the country, according to the report, has seen upwards of $1.5 billion from investors.

Even so, Dr. Irit Yaniv says that the Israeli biotech sector is enriched with but not yet dominated by women.

Dr. Yaniv is a less typical example, as she calls herself. The accomplished medtech and biopharma executive is a co-founder and investor now serving as a managing partner for health care venture capital fund Accelmed Ventures II. Dr. Yaniv has held top-level positions as CEO of heart medical device firm Impulse Dynamics and Type 2 diabetes treatment firm Metacure and a number of chairperson and board member positions at various medtech, biotech, and life science companies. She also co-founded Type 2 diabetes firm Digma Medical and obesity treatment firm NitiNotes Surgical.

But she also knows firsthand the obstacles women run into in the biotech industry. We do see many women holding mid-level positions, however when it comes to C-level (specifically, CEOs and chairperson positions), the picture is not much different from other sectors, she says.

And there is so much room for improvement. Women are still lacking the extensive networking ties and some assistance from our peers, she tells NoCamels. Women, especially younger women, are keen for proper mentoring to assist them to grow and stay at the top. I believe developing the right networks as well as other soft skills, will make a difference in the long run.

Realizing the need for mentorship and a support network for both newbies and veterans in the industry, Dr. Yaniv co-established a forum called Life Science Women. The open forum, which got too big for WhatsApp and is now on Telegram and LinkedIn, aims to establish a womens network for professional topics in the life sciences space, including HR, content, questions, lectures, and education.

The forum currently includes 300 women who use it on a daily basis, Dr. Yaniv says, with questions such as Who is willing to give a presentation at a conference? or Who knows a great service provider for regulatory matters?

Dr. Yaniv also believes another gap that prevents women from reaching high-level positions is the dissonance between how women perceive themselves and their real competencies and capabilities. For that reason, Dr. Yaniv, together with Ronit Harpaz, co-founder and CEO of medical device company Endoron Medical, and the support of the 8400 The Health Network, with a mission to advance the healthcare and life science industry in Israel, will be establishing an academic organization for junior women who have been recognized as having the potential to reach key managerial positions in their organizations. The academy will focus on teaching soft skills, networking, and specific theoretical content. It will also feature inspirational talks from prominent role models and theory segments from professional speakers.

Working together with the talented women that made it to the top, I believe we can make the change and, in the future, see more women in C-positions, including directors, she says. My wish is that there will be no need for specific women guidelines for places like board of directors, as there will be enough women holding senior positions everywhere.

SEE ALSO: Annual Biotech Confab Highlights Role of Advanced Tech Rehabilitation

Professor Carmi and Dr. Yaniv are just a few of the Israeli women who have made great strides for women in biotechnology. As the world marked International Womens Day 2020 on Sunday, NoCamels wanted to highlight the women who are making an impact in the field.

Professor Shulamit Levenberg, dean of the Faculty of Biomedical Engineering at the Technion Israel Institute of Technology, is one of the worlds leading scientists in the field of tissue engineering. As the head of the 3D Bio-Printing Center for Cell and Biomaterials Printing, launched last year, Levenberg is poised to lead the Technions tissue engineering into new territory. Professor Levenbergs stem cell and tissue engineering research has shown that it is possible to generate tissues and blood vessels in a lab that can in the future be implanted and integrated into human hosts.

Professor Levenberg is also the co-founder and Chief Scientific Officer of Aleph Farms, a clean meat Israeli company that unveiled the worlds first lab-grown steak prototype grown from animal cells in Dec 2018. Founded in 2017, Aleph Farms has raised more than $14 million and is working to transform its prototype into a commercial product.

Professor Levenberg has co-authored more than 100 publications, including six in 2019. In 2007, she appeared on Scientific Americans list of 50 leading scientists, Last year, she was named one of 50 influential women in 2019 by Israeli magazine Lady Globes.

Dr. Ora Dar has almost three decades of science, tech, and management experience, including 13 years as the head of the life sciences sector at the Israel Innovation Authority (then the Office of the Chief Scientist.) She also spent 16 years on academic research and has been a venture capital consultant for over two decades.

Today, Dr. Dar leads the National Infrastructure Forum for Research and Development (Telem) at the Israel Innovation Authority. She is also among the leaders of the Israeli National Genomic and Personalized Medicine Initiative, which includes a research-oriented genomic-clinical database of 100K volunteers.

Dr. Dar co-chairs the annual MIXiii-BIOMED Conference and Exhibition, a leading biotechnology and healthcare conference for both Israeli and international professionals.

Dr. Nuha Higazi, a neurology doctor, is the CTO and co-founder of PamBio, a biotechnology company developing drug therapy for hemorrhagic stroke (intracranial bleeding and ICH) and other acute bleeding conditions.

The company, co-founded with her husband Professor Abd Higazi with the support of Hadassah Medical Centers technology transfer company Hadasit, was conceived as part of the Nazareth-based incubator (NGT)3 and has received $7 million in a Series A round and $3 million from both (NGT)3 and the Israel Innovation Authority since it was founded in 2014.

Dr. Higazi is also the CTO and co-founder of medical device company Plas-free, which has developed ClearPlasma, a medical device that helps coagulation and complex treatments for massive bleeding. The company was founded in 2017.

Professor Mouna Maroun researches PTSD on animal models while focusing on developmental differences at the Univerity of Haifas Sagol Department of Neurobiology. She heads the Universitys Laboratory for Neurobiology of Emotions.

In 2018, Professor Maroun was named by the business publication TheMarker as one of the top 20 women changing the face of the Israeli medical scene today.

As an Arab woman, my belief is that the revolution towards gender and ethnic equality starts top-down at academic institutions, she told the University of Haifa magazine in 2018. Recruiting outstanding women as faculty members Jewish, Arab, Ethiopian and Haredi especially in sciences and STEM [Science, Technology, Engineering and Mathematics] subjects is one of the first steps to ensure the representation of women in higher education and to convey a clear message to the younger generation that there is no glass ceiling for girls.

Since joining genomics-based cancer immunotherapy and diagnostic discovery company Compugen in 2002, Dr. Anat Cohen-Dayag has held numerous positions including vice president of R&D as she climbed up the ladder. In 2010, Dr. Cohen-Dayag was named Compugens president and CEO and has been on the companys board of directors since 2014.

Last month, Compugen announced the expansion of its cooperation agreement with international firm Bristol-Myers Squibb to conduct cancer treatment trials. This week, the company reported promising data from on ongoing Phase 1 trial of its lead product candidate, COM701, a first-in-class anti-PVRIG antibody, for the treatment of solid tumors.

Dr. Cohen-Dayag is also the director of the Israel Advanced Technology Industry (IATI), Israels umbrella organization of high-tech and life science industries, heading up more than 700 members from every level and aspect of the ecosystem including venture capital funds, R&D centers, and startup incubators.

Another biotech force is Dr. Kinneret Livnat-Savitzky, the CEO of Israeli biotechnology accelerator FutuRx Ltd established in 2014. She joined Compugens board of directors in 2018.

She previously completed a seven-year stint as CEO of clinical-stage, publicly-traded biopharma company BioLineRX, which focuses on oncology, as well as seven years as VP of biology at Compugen.

Professor Ester Segal is currently leading a research group focusing on the broad interface between materials science and biotechnology in the Faculty of Biotechnology and Food Engineering at the Technion Israel Institute of Technology. She is also head of the Esther Segal lab at the Technion, which implements a multidisciplinary approach that couples materials science with engineering, and chemistry with biotechnology to address problems in biotechnology, food engineering, and medicine.

Professor Segal is a recipient of the 2019 Advances in Measurement Science Lectureship Award for her work on photonic crystal sensing.

Last year, she was named among the top 50 most influential women in Israel in 2019 by Lady Globes magazine.

Nora Nseir is the co-founder and CTO of Nurami Medical, a medical device company with a breakthrough nanofiber and sealant technology for the soft tissue repair market. Nseir, a biomedical engineer co-founded the startup in 2014 with Dr. Amir Bahar, a multidisciplinary entrepreneur and neuroscientist. Nseir previously held R&D positions in the medical devices industry focusing on the development of bone grafts and hemostatic devices.

In 2015, she co-founded the Arab Women in Science forum, which encourages Arab women and girls in sciences and entrepreneurship.

In 2017 and 2018, Nseir was also included in the Lady Globes Women of Influence list.

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Clemson geneticists’ collaborative research sheds light on ‘dark’ portion of genome – Clemson Newsstand

March 9th, 2020 7:45 pm

CLEMSON, South Carolina Just as there is a mysterious dark matter that accounts for 85 percent of our universe, there is a dark portion of the human genome that has perplexed scientists for decades. A study published March 9, 2020, in Genome Research identifies new portions of the fruit fly genome that, until now, have been hidden in these dark, silent areas.

The collaborative paper titled Gene Expression Networks in the Drosophila Genetic Reference Panel is the culmination of years of research by Clemson University geneticists Trudy Mackay and Robert Anholt. Their groundbreaking findings could significantly advance sciences understanding of a number of genetic disorders.

Robert Anholt (left) and Trudy Mackay in their lab at the Clemson Center for Human Genetics.Image Credit: Robert Bradley, College of Science

The dark portion refers to the approximate 98 percent of the genome that doesnt appear to have any obvious function. Only 2 percent of the human genome codes for proteins, the building blocks of our bodies and the catalysts of the chemical reactions that allow us to thrive. Scientists have been puzzled by this notion since the 1970s when gene sequencing technologies were first developed, revealing the proportion of coding to noncoding regions of the genome.

Genes are traditionally thought to be transcribed into RNAs, which are subsequently translated into proteins, as dictated by the central dogma of molecular biology. However, the entire assemblage of RNA transcripts in the genome, called the transcriptome, contains RNA species that appear to have some other function, apart from coding for proteins. Some have proposed that noncoding regions might contain regulatory regions that control gene expression and the structure of chromosomes, yet these hypotheses were difficult to study in past years as diagnostic technology was developing.

Only in recent years, with the sequencing of the entire transcriptome complete, have we realized how many RNA species are actually present. So, that raises the whole new question: if they arent making the proteins the work horses of the cell then what are they doing? said Mackay, director of Clemson Universitys Center for Human Genetics (CHG), which is part of the College of Science.

For Mackay and Anholt, also of the CHG, these human genetics questions can be probed by studying the common fruit fly, Drosophila melanogaster. Because many genes are conserved between humans and fruit flies, findings revealed by analyzing the Drosophila genome can be extrapolated to human health and disease.

Mackay and Anholts former postdoctoral researchers, Logan Everett and Wen Huang, led the charge on this latest research, which identified more than 4,500 new transcripts in Drosophila that have never been uncovered before. Referred to by the researchers as novel transcribed regions, these 4,500 transcripts consist primarily of noncoding RNAs that appear to be involved in regulating networks of genes and that could contribute to genetic disorders.

Most disease-causing mutations are known to occur in the protein-coding portion of the genome, known as the exome, but when youre only sequencing the exome, you miss other disease-related factors in other parts of the genome, such as these long noncoding RNAs, said Anholt, Provosts Distinguished Professor of Genetics and Biochemistry at Clemson University. Now that the cost of whole genome sequencing has gone down considerably, and we have the capability of sequencing whole genomes rapidly, we can look at elements of the genome that have traditionally been considered unimportant, and we can identify among them potential disease-causing elements that have never been seen before.

By probing several hundred inbred Drosophila fly lines, each containing individuals that are virtually genetically identical, the researchers discovered that many of the novel long noncoding RNAs regulate genes in heterochromatin, a tightly packed form of DNA in the genome that is usually considered silent. Because heterochromatin is so condensed, it was thought to be inaccessible to the molecular machinery that transcribes DNA into RNA. Thus, any genes contained within heterochromatin are kept off, silent and unexpressed or are they?

What we think is that the repression of gene expression in heterochromatin is somewhat leaky, and that there is variation in how those genes are repressed, Mackay said. The network of RNAs weve discovered may have to do with actually regulating chromatin state.

These noncoding RNAs may play an important role in opening up such regions of the genome for expression of genes in a way that varies among different individuals depending on their genetic background, Anholt added.

Trudy Mackay and Robert Anholt address human genetics questions by studying the common fruit fly, Drosophila melanogaster, because many genes are conserved between humans and fruit flies, meaning research results can be extrapolated to human health and disease.Image Credit: College of Science

Another outcome of the study is the expression of jumping genes, known as transposons, that are pieces of DNA able to move around the genome. As transposons cut and paste into other genes, they may cause genome instability that leads to cancer, neurodegenerative disorders and other diseases. These transposons were also located in heterochromatin, but the identification of transcripts of these transposons shows that they are actually being expressed, despite residing in a usually silent portion of the genome. Identifying regulators of transposable elements, as the researchers found among these 4,500 novel transcribed regions, could prove useful in treating disorders that stem from transposon interference.

Overall, the study lends toward a greater understanding of gene regulatory networks that contribute to human health and disease.

These observations open up an entirely new area of biology that hasnt been explored and has unlimited potential for future follow-up, Anholt said.

The teams own follow-up studies are using CRISPR gene editing technology to uncover what happens when genes revealed by this study are altered or deleted from the Drosophila genome. If the expression of other genes is altered by knocking one out, important conclusions can be drawn about the role that deleted gene plays in development or progression of disease.

Everett, one of the lead authors on the Genome Research publication, is now a bioinformatics scientist at the U.S. Environmental Protection Agency. Wen Huang is an assistant professor in the Department of Animal Science at Michigan State University.

###

The study was supported by the National Institutes of Health under grant numbers R01-AA016560, R01-AG043490 and U01- DA041613. Additional support was provided by The Danish Council for Strategic Research. The researchers are wholly responsible for the content of this study, of which the funders had no input.

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NorthShore Moving Toward Greater Integration of Genomics Into Primary Care – GenomeWeb

March 9th, 2020 7:45 pm

NEW YORK After assessing the impact genetic information can have on patient care within clinics and pilot programs, NorthShore University HealthSystem is working on expanding test access to primary care patients and integrating the results into their day-to-day care.

In 2020, "we're trying to focus on how to hardwire this so it's not just a bunch of pilots but really starting to be ingrained in practice," said Peter Hulick, medical director of NorthShore's Center for Personalized Medicine.

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Podcast: Bird poop, pus, and the Manhattan projectthe surprising origins of the genetic alphabet – Genetic Literacy Project

March 9th, 2020 7:45 pm

On the latest episode of Genetics Unzipped, biologist Kat Arney explores the origins of the genetic alphabet: A, C, T and Gthe four letters that spell out all the genetic recipes encoded in DNA.

These letters are the initials of the four nucleotide chemicals that make up DNA: adenine, cytosine, thymine and guanine. They are ingrained in the scientific lexicon and burned into the brain of anyone whos ever worked with or even just learned about genes, genomes and DNA. Its a code thats as inseparable from genetics as the double helix itself.

But while many people know that the structure of DNA was figured out in the 1950s, far fewer people realize that the identities of these molecular letters were uncovered far earlier. In search of the origins of nucleotide names, Arney takes us from the bird poop boom of the 1840s through the heyday of atomic weapons research in the 1940s and beyond.

First we explore the guano mountains of Peru giant hills of solidified seabird excrement which were mined for fertilizer to feed a fast-developing world. Intrigued by the nourishing properties of guano, 19th-century scientists started to investigate its chemical components. This led to German chemist Julius Ungers discovery of guanine in 1846 the first nucleotide molecule to be identified.

DNA itself wasnt discovered until nearly twenty years later, when Johannes Friedrich Miescher isolated a strange sludgy substance from pus-soaked bandages obtained from a nearby clinic. He called it nuclein a name that still lingers in the formal chemical name for DNA, deoxyribonucleic acid. However, his discovery almost went ignored as his supervisor, Felix Hoppe-Seyler, did not believe that such an inexperienced researcher could make such an important finding.

Following up on Mieschers work, his colleague Albrecht Kossel identified cytosine, thymine and adenine as the other components of this mysterious nuclein, after purifying the chemicals from huge amounts of cow organs obtained from a nearby slaughterhouse.

The story of nucleotides doesnt end with the discovery of A, C, T and G. Although these four letters make up the genetic code of DNA, theres another base Uracil, or U that replaces thymine in RNA, a kind of molecular photocopy thats made when genes are read. And we also now know that DNA and RNA bases can be chemically altered to extend the genetic code in some very interesting ways. Finally, we hear how the discovery of the first modified RNA base, pesudouridine, came from a surprising source: the US atomic weapons program at Oak Ridge laboratory in Tennessee.

Full transcript, links and references available online atGeneticsUnzipped.com

Genetics Unzippedis the podcast from the UKGenetics Society,presented by award-winning science communicator and biologistKat Arneyand produced byFirst Create the Media.Follow Kat on Twitter@Kat_Arney,Genetics Unzipped@geneticsunzip,and the Genetics Society at@GenSocUK

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The Biology Behind Your Love (or Hatred) of Coffee – Technology Networks

March 9th, 2020 7:45 pm

Why do some people feel like they need three cups of coffee just to get through the day when others are happy with only one? Why do some people abstain entirely? New research suggests that our intake of coffee - the most popular beverage in America, above bottled water, sodas, tea, and beer - is affected by a positive feedback loop between genetics and the environment.

This phenomenon, known as "quantile-specific heritability," is also associated with cholesterol levels and body weight, and is thought to play a role in other human physiological and behavioral traits that defy simple explanation.

"It appears that environmental factors sort of set the groundwork in which your genes start to have an effect," said Paul Williams, a statistician at Lawrence Berkeley National Laboratory (Berkeley Lab). "So, if your surroundings predispose you to drinking more coffee - like your coworkers or spouse drink a lot, or you live in an area with a lot of cafes - then the genes you possess that predispose you to like coffee will have a bigger impact. These two effects are synergistic."

Williams' findings, published in the journalBehavioral Genetics, came from an analysis of 4,788 child-parent pairs and 2,380 siblings from the Framingham Study - a famous, ongoing study launched by the National Institutes of Health in 1948 to investigate how lifestyle and genetics affect rates of cardiovascular disease. Participants, who are all related to an original group from Framingham, Massachusetts, submit detailed information about diet, exercise, medication use, and medical history every three to five years. Data from the study have been used in thousands of investigations into many facets of human health.

Williams used a statistical approach called quantile regression to calculate what proportion of participants' coffee drinking could be explained by genetics - as the study follows families - and what must be influenced by external factors. Past research shows that the most significant environmental factors influencing coffee drinking are culture and geographic location, age, sex, and whether or not one smokes tobacco; with older male smokers of European ancestry drinking the most, overall.

The analysis indicated that between 36% and 58% of coffee intake is genetically determined (although the exact causative genes remain unknown). However, confirming Williams' hypothesis that coffee drinking is a quantile-specific trait, the correlation between a parent's coffee drinking and an offspring's coffee drinking got increasingly stronger for each offspring's coffee consumption quantile, or bracket (for example, zero cups per day, one to two cups, two to four cups, and five or more cups).

"When we started to decode the human genome, we thought we'd be able to read the DNA and understand how genes translate into behavior, medical conditions, and such. But that's not the way it's worked out," said Williams, who is a staff scientist in Berkeley Lab's Molecular Biophysics & Integrated Bioimaging (MBIB) Division. "For many traits, like coffee drinking, we know that they have a strong genetic component - we've known coffee drinking runs in families since the 1960s. But, when we actually start looking at the DNA itself, we usually find a very small percentage of the traits' variation can be attributed to genes alone."

The traditional assumption in genetic research has been that one's surroundings and lifestyle alter gene expression levels in consistent and measurable ways, ultimately creating the outward manifestation - called a phenotype - of a trait. Williams' statistics work shows that the situation is more complex, which helps explain the diversity of traits we see in the real world.

MBIB Division Director Paul Adams commented, "Paul's statistical studies complement the genomics research that Berkeley Lab bioscientists conduct to learn more about the relationship between genes and the environment."

Next, Williams plans to assess whether quantile-specific heritability plays a role in alcohol consumption and pulmonary function. "This is a whole new area of exploration that is just now opening up," he said. "I think it will change, in a very fundamental way, how we think genes influence a person's traits."

Reference:Paul T. Williams. (2020).Quantile-Specific Heritability may Account for GeneEnvironment Interactions Involving Coffee Consumption. Behavior Genetics.DOI: https://doi.org/10.1007/s10519-019-09989-0.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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A Conversation With a Harvard Geneticist on How to Live (Well) Past 100 – InsideHook

March 9th, 2020 7:45 pm

In Parks and Rec, Rob Lowes Chris Traeger is a perennially positive, supplement-popping 45-year-old who glides through the rooms of Pawnee City Hall with golden retriever energy. He brings vegetable loaves to birthday parties, regularly runs 10 miles during his lunch breaks and touts just 2.8% body fat. In Season 2 of the show, Traeger reveals his lifes goal: to live to 150.

Scientists believe that the first human being to live to a 150 years has already been born I believe I am that human being. At first, it sounds like just another quotable line from a show thats famous for them. Traeger isnt to be taken seriously, after all. One of his other signature adages is simply Stop pooping. (On the exceedingly rare occasions that Traegers body fails him, he lands in a dark place.)

Believe it or not, though, Traegers right. At least one scientist has been predicting humankinds potential to live to 150 for the better part of a decade, a man whos furthered the notion of aging as disease since he arrived at MIT in the late 1990s. That would be Australian Dr. David Sinclair, a biology rockstar and former Time 100 honoree with an Order of Australia (Down Unders version of knighthood), and his own genetics lab at Harvard Medical School.

In September of last year, Dr. Sinclair released Lifespan: Why We Age and Why We Dont Have To. Its an explosive call to arms detailing Dr. Sinclairs core belief, which hes spent decades researching: most humans leave decades of high-quality life on the table simply because society doesnt afford aging the same attention and dollars it reserves for other health crises like cancer and heart disease. The book is one part memoir (Dr. Sinclair recalls the drawn-out final decades of his mother and grandmothers lives), one part crash-course in epigenetics (we hold far more in common with yeast cells than the common person knows) and one part sneak peek into the advancements being made in the worlds preeminent genetics labs (Dr. Sinclairs team has successfully cured blindness in mice).

Most refreshingly, though, Lifespan delights in giving answers. On top of the many science-fiction-esque wonders on display at Harvard Medical School each week (Dr. Sinclair is a pioneer of a practice called cellular programming, which effectively means resetting cells back to a younger age), the book includes functional day-to-day advice on how the layman or woman can activate survival processes in their epigenome, engaging specific sirtuin proteins (a class of protein that helps regulate cellular aging) to help foster greater longevity.

Basically, Sinclairs hypothesis is that eating a certain way, working out a certain way and exposure to a certain kind of temperature can make living past 100 a relative breeze. We recently caught up with Dr. Sinclair to discuss his book, intermittent fasting, Benjamin Button and more.

InsideHook: This book definitely doesnt mince concepts or words. Why was it important to you to write so boldly on aging as a disease?

Dr. David A. Sinclair: The world is in a stupor when it comes to aging. Theres a blind spot. I wrote the book to shake things up, and hopefully wake up those who dont think aging is important or worth working on. We focus as a society far too much on the end consequence of aging, playing whack-a-mole with these diseases that kill us. We ignore whats actually driving these diseases. The more we study aging, though, the more we realize that the diseases we treat are all manifestations of an underlying process. And its treatable.

Some of your peers in the field have said it isnt a good look to be so declarative in your predictions on aging. Have they changed their tune since the book was released?

I havent had any criticism from colleagues since the book came out. Either they havent read it, or theyre okay with my arguments. But also, the world is changing. What used to be considered crazy 10 years ago is no longer crazy. For example, scientists didnt used to say the phrase reversal of aging. But now, its a fact thats doable. Our field has proven that many aspects of aging are reversible, including blindness. Its also partly that I was ahead of the curve, and that things which were once forbidden are now in the realm of discussion and debate.

Im fascinated by the cellular reprogramming work your lab has done. In the book, you invoke F. Scott Fitzgeralds Benjamin Button story to describe how a 50-year-old could soon begin a routine that will have him/her feeling and looking 30 again. Are we actually close to seeing that sort of treatment in the developed world?

The first thing to say is we now understand that changes in your lifestyle can dramatically improve your age and physiology. We used to think that aging was just something that was in our genes, something that we couldnt modify. But very rapidly, within months of changing diet and exercise, you can reverse many aspects of aging. Its never too late, unless youre on your last legs. The fact that its that easy to slow down and reverse aspects of aging just with lifestyle changes totally fits with our understanding of molecular mechanisms. We should be able to slow aging even better with the reprogramming of cells. I see the work weve done as a proof of concept. While its true that Im working hard towards restoring eyesight in people whove lost their vision, its really just the beginning. This work is proof that its possible to restore the age of a complex tissue. In the same way that the Wright brothers werent building rockets to the moon, they could at least imagine that one day it would be possible. Weve shown that there is a backup copy of a youthful epigenome that we can turn on to reset the cell and get it to work again. If thats doable in the eye, it would be rather pessimistic to say we were just lucky to choose the right body part for this to work.

High-intensity training is one of the practices you cite as vital to this process. What about it encourages longevity genes?

Weve found that high-intensity training will induce the sirtuin defenses in the body, similar to what intermittent fasting does. When those genes come on, they defend the cell against diseases, and aging itself. When we dont engage those sirtuin genes, we dont reap the benefits. High-intensity training is particularly good at turning on the sirtuins, because it encourages a hypoxic response, which weve shown leads to the activation of these defense mechanisms. While walking is good, its not as good as doing high-intensity training.

Im glad you mentioned intermittent fasting, another practice you endorse. Are there any mistruths or misunderstandings in the way that popular media portrays it?

Based on recent results in animal studies, its not so much what you eat but when you eat. Of course, you cant eat a hamburger morning, noon and night, then fast the next day and expect to get the maximum benefits. That said, it seems to be more about just having a period of fasting in general. Theres one misconception that people need an optimal mix of protein, carbohydrates and fat, and that thats the most important thing to get right. Id say worry about that less, as long as youre getting nutrients and xenohormetic molecules, which are molecules produced by plants when theyre under stress. As long as youre doing those things, its far more important to skip meals.

One other thing: people claim that there is an optimal intermittent fasting protocol. The truth is, we dont know what the optimal is. Were still learning, and its individual. There are individual differences in all of us. There is a subset of people, myself included, who start producing glucose out of their livers early in the morning, at around 6 a.m. Which means, for me, to start eating breakfast around 7 a.m. makes no sense. Some people, though, have such low blood sugar in the morning that they can barely function. We also dont know the best method. Is it the 16/8 [hours, first on and then off of the fast]? Two days fasting out of every five? We really dont know yet. But we do know that if youre never hungry, if youre eating three meals a day and snacking in between, thats the worst thing you can do. It switches off your bodys defenses. Some fasting is better than none.

Do you eat meat?

I do, but its a gradient. Its mostly plants, then fish, rarely chicken, and almost never red meat.

From an aging perspective, do you recommend that people give up meat?

For the average person, focus on plants. Meat isnt going to kill you if you eat it once in a while, but the reason for the plant-based diet is we know where the hot spots are for longevity. We know what theyre eating. Its not a mystery. Theyre not carnivores. Theyre eating mostly plants, and a little bit of meat maybe, a bit of fish. Theyre consuming olive oil, avocados, red wine and other plants that have xenohormetic molecules. I dont think that thats a coincidence.

Theres been some coverage recently about the rise of wild swimming. In the UK, especially, people have started jumping into freezing cold water and claiming all sorts of health benefits. It reminded me of your points in the book about challenging the thermoneutral zone. Does one need to frequently experience extremely cold temperatures to reap benefits?

Cold baths, cryotherapy I was skeptical. I started out skeptical until proven otherwise. But theres some evidence that making brown fat is good. Adult humans can make brown fat as long as theyre not super old, and cold is a good way to do that. One of my favorite genes, the third of the seven sirtuin genes, boosts brown fat. All of these things that were talking about exercise, fasting, cold therapy, even a sauna its best to mix it up. You dont want to be constantly exercising, constantly hungry, or constantly at one temperature or another. You want to shock the body. Putting a few days of recovery in between makes a lot of sense. As for exposing yourself to cold, a little is still better than nothing. I do it once a week. But Im still trying to figure out when to do these ice baths. There was a study that an ice bath after a workout potentially lowers the benefit of the workout.

Lifespan devotes a ton of pages to metformin, the anti-diabetic medication thats been discovered to activate longevity genes. Are there adverse side effects from taking metformin? It seems a little too good to be true.

As far as drugs go, metformin is very safe. The World Health Organization declared it one of the essential medicines for humanity. One in 10,000 people have an adverse side reaction and have to stop taking it. The majority of complaints are attributed to a queasy stomach feeling until you get used to it. I actually dont mind, because it stops me from getting hungry. [Editors note: Dr. Sinclair takes metformin daily.] It doesnt give you anything like a greater risk of cancer or heart disease. The data actually suggests the opposite. The risk of getting old is pretty high, but the risk of taking metformin is pretty low, based on millions of people taking it.

Youre on the record saying the first person to live to 150 has been born. Would that person need to combine every single practice and innovation that you outline in this book in order to do so?

An important point of clarification: I dont think we have any technology today that would get us to 150. But if youre born today, you can be around until the mid-22nd century. Theres a lot thats going to happen between now and then. Were on a path of technological development. Once you see the trajectory and barriers are broken down, it gives me the license to say someone born today will live far longer than we can imagine. People born today will benefit from technologies that come about after were dead. The big breakthrough is being able to reprogram the body. If we can get that to work, wed be literally able to turn the clock back on cells. Weve done it once we managed to restore vision in mice but you might be able to reset cells twice. Or 100 times. Well just have to see.

Related: The Healthiest Blue Zone in Every State, Mapped

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A Conversation With a Harvard Geneticist on How to Live (Well) Past 100 - InsideHook

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The complex biology behind your love (or hatred) of… – ScienceBlog.com

March 9th, 2020 7:45 pm

Why do some people feellike they need three cups of coffee just to get through the day when others are happy with only one? Why do some people abstain entirely? New research suggests that our intake of coffee the most popular beverage in America, above bottled water, sodas, tea, and beer is affected by a positive feedback loop between genetics and the environment.

This phenomenon, known as quantile-specific heritability, is also associated with cholesterol levels and body weight, and is thought to play a role in other human physiological and behavioral traits that defy simple explanation.

It appears that environmental factors sort of set the groundwork in which your genes start to have an effect, said Paul Williams, a statistician at Lawrence Berkeley National Laboratory (Berkeley Lab). So, if your surroundings predispose you to drinking more coffee like your coworkers or spouse drink a lot, or you live in an area with a lot of cafes then the genes you possess that predispose you to like coffee will have a bigger impact. These two effects are synergistic.

Williams findings, published in thejournal Behavioral Genetics, came from an analysis of 4,788 childparent pairs and 2,380 siblings from the Framingham Study a famous, ongoing study launched by the National Institutes of Health in 1948 to investigate how lifestyle and genetics affect rates of cardiovascular disease. Participants, who are all related to an original group from Framingham, Massachusetts, submit detailed information about diet, exercise, medication use, and medical history every three to five years. Data from the study have been used in thousands of investigations into many facets of human health.

Paul T. Williams. (Credit: Roy Kaldschmidt/Berkeley Lab)

Williams used a statistical approach called quantile regression to calculate what proportion of participants coffee drinking could be explained by genetics as the study follows families and what must be influenced by external factors. Past research shows that the most significant environmental factors influencing coffee drinking are culture and geographic location, age, sex, and whether or not one smokes tobacco; with older male smokers of European ancestry drinking the most, overall.

The analysis indicated that between 36% and 58% of coffee intake is genetically determined (although the exact causative genes remain unknown). However, confirming Williams hypothesis that coffee drinking is a quantile-specific trait, the correlation between a parents coffee drinking and an offsprings coffee drinking got increasingly stronger for each offsprings coffee consumptionquantile, or bracket (for example, zero cups per day, one to two cups, two to four cups, and five or more cups).

When we started to decode the human genome, we thought wed be able to read the DNA and understand how genes translate into behavior, medical conditions, and such. But thats not the way its worked out, said Williams, who is a staff scientist in Berkeley Labs Molecular Biophysics & Integrated Bioimaging (MBIB) Division. For many traits, like coffee drinking, we know that they have a strong genetic component weve known coffee drinking runs in families since the 1960s. But, when we actually start looking at the DNA itself, we usually find a very small percentage of the traits variation can be attributed to genes alone.

The traditional assumption in genetic research has been that ones surroundings and lifestyle alter gene expression levels in consistent and measurable ways, ultimately creating the outward manifestation called a phenotype of a trait. Williams statistics work shows that the situation is more complex, which helps explain the diversity of traits we see in the real world.

MBIB Division Director Paul Adams commented, Pauls statistical studies complement the genomics research that Berkeley Lab bioscientists conduct to learn more about the relationship between genes and the environment.

Next, Williams plans to assess whether quantile-specific heritability plays a role in alcohol consumption and pulmonary function. This is a whole new area of exploration that is just now opening up, he said. I think it will change, in a very fundamental way, how we think genes influence a persons traits.

This research was funded by a grant from the National Institute of Environmental Health Sciences and a gift from HOKA ONE ONE. The Framingham Study Data were made available through the Biologic Specimen and Data Repository Information Coordinating Center of the National Heart, Lung, and Blood Institute.

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Blue Shield of California Becomes First Health Plan in US to Cover Cost of Rapid Whole Genome Sequencing for Critically Ill Children – Hispanic PR…

March 9th, 2020 7:45 pm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Coronavirus: Risk of death rises with age, diabetes and heart disease – New Scientist News

March 9th, 2020 7:44 pm

By Jessica Hamzelou

Fei Maohua/Xinhua News Agency/PA Images

People who have the new coronavirus are most likely to die if they are older or show signs of sepsis or blood clotting problems. Thats according to a study that followed a small group of people infected with the covid-19 virus from diagnosis to hospital discharge or death.

Early on in the outbreak, two hospitals in Wuhan were designated to treat people who were infected with the new coronavirus. Until 1 February, people who were diagnosed with the virus in other hospitals were transferred to one of the two for care.

By January 31, 191 adults had been treated for the virus and either discharged or died at one of the two hospitals. Bin Cao at the China-Japan Friendship Hospital and Capital Medical University in Beijing, and his colleagues assessed these cases, looking for patterns in the characteristics of those who survived the virus and those who didnt.

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The average age of these individuals was 56, and 62 per cent of them were men. Around half of them had underlying medical conditions most commonly high blood pressure and diabetes.

Of the 191 individuals, 137 were eventually discharged and 54 died. The average time from the onset of the illness to discharge from hospital was 22 days, the team say. Those that didnt survive the virus died an average of 18.5 days after symptoms began.

Death was more likely in people who already had diabetes or coronary heart disease. Older people were more likely to die, as were those showing signs of sepsis or blood clotting problems. Overall, more than half of those hospitalised with the virus developed sepsis.

Poorer outcomes in older people may be due, in part, to the age-related weakening of the immune system and increased inflammation that could promote viral replication and more prolonged responses to inflammation, causing lasting damage to the heart, brain and other organs, said study co-author Zhibo Liu at Jinyintan Hospital in Wuhan.

The team also found that people with covid-19 continue to shed the virus, and could potentially be able to infect others, for around 20 days, or until they die. The extended viral shedding noted in our study has important implications for guiding decisions around isolation precautions and antiviral treatment in patients with confirmed covid-19, said Cao.

Journal reference: The Lancet, DOI: 10.1016/ S0140-6736(20)30566-3

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2020 Disease Analysis on Type 1 Diabetes – Licensing and Asset Acquisition Deals – Yahoo Finance

March 9th, 2020 7:44 pm

DUBLIN, March 9, 2020 /PRNewswire/ -- The "Disease Analysis: Type 1 Diabetes" report has been added to ResearchAndMarkets.com's offering.

Research and Markets Logo

The research estimates that in 2018, there were approximately 46.6 million prevalent cases of type 1 diabetes in adults aged 20 years and over worldwide, and forecasts that number to increase to 51.8 million prevalent cases by 2027.

In children and adolescents aged below 20 years, there were approximately 1.08 million prevalent cases of type 1 diabetes worldwide in 2018, which are expected to increase to 1.12 million prevalent cases by 2027.

The overall likelihood of approval of a Phase I type 1 diabetes asset is 16.3%, and the average probability a drug advances from Phase III is 73.9%. Type 1 diabetes drugs, on average, take 8.5 years from Phase I to approval, which is the same as the average duration to approval in the overall endocrine space.

Despite the presence of multiple well-established products, the type 1 diabetes market is expected to see limited growth over the next decade. Future growth opportunities in the type 1 diabetes market are expected to be limited by its saturation with multiple maturing insulins, pricing pressures following the launches of biosimilars, and the expected failure of sodium-glucose cotransporter-2 (SGLT-2) inhibitors to gain approval in the lucrative US market.

It is expected that patients will continue to switch from Novo Nordisk's Levemir to its successor product Tresiba due to the company's promotion of Tresiba's longer duration of blood sugar control compared to Levemir.

Likewise, Sanofi is pursuing a comparable commercial strategy to Novo Nordisk by promoting its next-generation insulin glargine product Toujeo over Lantus, as Lantus continues to lose patient share to the more affordable biosimilar Basaglar. However, key opinion leaders interviewed by the research analysts suggest that physicians are unconvinced that Toujeo possesses tangible benefits over biosimilar insulin glargine to justify its higher price.

Payers are severely restricting the use of specific insulin brands in the US. As the list price of insulins continues to increase, cost is becoming a strong determining factor for the choice of insulin treatment. Interviewed endocrinologists emphasized the impact of pricing on prescribing trends, as price fluctuations in the US lead to regular switching among patients.

Tresiba is forecasted to see the greatest uptake of all the long-acting insulin therapies in type 1 diabetes. Its long-acting duration of 42+ hours and its flexible dosing window (it can be administered at different times each day) offer improved convenience for patients, along with strong glycated hemoglobin (HbA1c) reductions. In addition, favorable pricing compared to Lantus and Toujeo within the US market is expected to drive growth of Novo Nordisk's market share.

The maturation of multiple short-acting insulin products has resulted in companies promoting switching to successor products with extended patent protection to maintain their diabetes revenues. Novo Nordisk's NovoLog will be facing biosimilar competition from Sanofi's SAR341402, therefore Novo Nordisk is actively encouraging patients to switch to NovoLog's successor ultra-rapid product Fiasp, which is positioned as having a faster onset of activity than NovoLog. Similarly, Eli Lilly has developed a faster-acting version of Humalog, ultra-rapid lispro, which is currently in preregistration in the US.

Increasing out-of-pocket costs for patients and competition from Sanofi's Admelog (a biosimilar of Humalog) have resulted in developers of branded products launching authorized generics in order to increase competitiveness in US government-insured patients, who must make co-payments based on a percentage of a drug's list price. In May 2019, Eli Lilly launched an authorized generic of Humalog at 50% of the list price of branded Humalog in hopes of maintaining government-insured patient share. This was followed in January 2020 by Novo Nordisk's launch of an authorized generic version of NovoLog, also at a 50% discount to the branded product.

Pipeline product teplizumab has shown promising potential to prevent or delay the onset of type 1 diabetes, as Phase II data have demonstrated that a single course of the drug significantly delayed disease onset in at-risk patients by a median of two years. The data will support a planned rolling Biologics License Application (BLA) submission for the prevention or delay of type 1 diabetes in H1 2020, and the review process will be fast tracked due to breakthrough therapy designation granted by the US Food and Drug Administration (FDA). However, if approved, teplizumab is likely to face two challenges when attempting to enter the market, the first of which is appropriately pricing the product to reflect the market value of delaying or preventing diabetes while ensuring that a high upfront cost does not prevent reimbursement. Indeed, achieving widespread reimbursement will be particularly challenging given the lack of a currently approved comparator and the fact that the mean duration of any delay in the onset of diabetes may not be known at the time of approval. The second challenge is the lack of existing screening programs to detect patients that are at risk for type 1 diabetes, which could severely limit the drug's target population (at least initially). Teplizumab's commercial success will therefore require healthcare services, physicians, and industry to collaborate on creating and integrating accessible screening programs into different health services globally.

Lexicon continues to pursue first-to-market status for Zynquista for type 1 diabetes in the US, and launched an appeal against the FDA's initial complete response letter (CRL), but this was unsuccessful. Thus, the company has now appealed to the Center for Drug Evaluation and Research, and is expecting a final judgment to be made in February 2020, but we expect this will also fail given that no new trial data have been added to the NDA to allay safety concerns and Lexicon has stated it does not wish to initiate further studies. An FDA decision on Jardiance's supplementary New Drug Application (sNDA) is expected in late Q1/early Q2, but a rejection is widely expected given the Endocrinologic and Metabolic Drugs Advisory Committee panel voted 14-2 against approval in November 2019. While SGLT-2 inhibitors may offer benefits to type 1 diabetes patients beyond improved glycemic control (namely blood pressure reduction and weight loss), our base case is that the class will not gain FDA approval for type 1 diabetes without additional studies to further investigate the risk of diabetic ketoacidosis (DKA) and the effectiveness of proposed risk-management strategies, and thus far none of the companies have publicly announced any intention to conduct such studies.

Key Topics Covered:

1. OVERVIEW

Story continues

2. DISEASE BACKGROUND

3. TREATMENT

4. EPIDEMIOLOGY

5. MARKETED DRUGS

6. PIPELINE DRUGS

7. KEY REGULATORY EVENTS

8. PROBABILITY OF SUCCESS

9. LICENSING AND ASSET ACQUISITION DEALS

10. CLINICAL TRIAL LANDSCAPE

11. DRUG ASSESSMENT MODEL

12. MARKET DYNAMICS

13. FUTURE TRENDS

14. CONSENSUS FORECASTS

15. RECENT EVENTS AND ANALYST OPINION

16. KEY UPCOMING EVENTS

17. KEY OPINION LEADER INSIGHTS

18. UNMET NEEDS

19. BIBLIOGRAPHY

20. APPENDIX

For more information about this report visit https://www.researchandmarkets.com/r/b9zitm

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Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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View original content:http://www.prnewswire.com/news-releases/2020-disease-analysis-on-type-1-diabetes---licensing-and-asset-acquisition-deals-301019775.html

SOURCE Research and Markets

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2020 Disease Analysis on Type 1 Diabetes - Licensing and Asset Acquisition Deals - Yahoo Finance

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