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Gilead Sciences and Renown Institute for Health Innovation Announce Strategic Collaboration to Advance Understanding of Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences, Inc. (Nasdaq: GILD) and the Renown Institute for Health Innovation (IHI) today announced a strategic collaboration to collect and analyze genetic and electronic health data that can enhance the understanding of nonalcoholic steatohepatitis (NASH) and potentially inform development of treatment options for the disease. Under the terms of the collaboration and license agreement, Gilead will provide funding to Renown IHI to sequence and analyze the DNA of 15,000 individuals living with NASH or nonalcoholic fatty liver disease (NAFLD) as well as a control cohort of 40,000 individuals in Nevada. “Combining the sequencing of protein coding DNA, with extensive electronic health record data will enable a deep analysis of the roles of genetics and environment in NASH incidence and progression,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “The analysis of these large datasets in collaboration with Renown IHI could help identify genetic variants that impact the risk of developing NASH and thereby advance the discovery and development of new treatments for this disease.” Renown Health is Nevada’s most comprehensive and integrated healthcare network and maintains electronic health records for 1.02 million registered patients. In 2016, Renown Health and the Desert Research Institute established the Healthy Nevada Project (HNP), the nation’s first community-based population health study. In 2017 HNP began a partnership with Helix to leverage its population health services, Exome+™ sequencing, and consumer engagement tools. The HNP is now an ongoing collaboration between Renown IHI, the Desert Research Institute, a global leader in environmental data and applied research, and Helix, a personal genomics company. HNP combines genetic, environmental, social and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The HNP currently has 40,000 participants. “Combining genetic sequencing with large sets of data can play a critical role in understanding and identifying serious health risks, including diseases like NASH. We are excited to collaborate with Gilead to better understand the condition and its complexities,” said Anthony Slonim, MD., DrPH. “Any genetic variants identified in participants through the collaboration may be shared with the participants for patient care purposes.” About NASH Nonalcoholic steatohepatitis (NASH) is a chronic form of liver disease characterized by excess fat in the liver, inflammation, and liver cell damage. Inflammation and liver cell damage can cause scarring of the liver, or fibrosis, and ultimately lead to cirrhosis or liver cancer. NASH is more common in people with certain conditions, including obesity and type 2 diabetes. There are currently limited approved treatments for patients living with NASH. About Gilead Sciences Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com. About Renown Health Renown Health is a locally governed and locally owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California. Renown is one of the region’s largest private employers with a workforce of more than 7,000. It comprises three acute care hospitals, a rehabilitation hospital, the area’s most comprehensive medical group and urgent care network, and the region’s largest and only locally owned not-for-profit insurance company, Hometown Health. Renown Health’s commitment has extended beyond traditional health care to include community health and well-being. Renown Health works to improve health care through science, research and genetics; forge community partnerships that improve lives and develop innovative models that are improving health care in Nevada. For more information, visit renown.org. About Helix Helix’s mission is to empower every person to improve their life through DNA. Helix is accelerating the integration of genomic data into clinical care and broadening the impact of large-scale population health programs by providing comprehensive expertise in DNA sequencing, bioinformatics, and individual engagement. Powered by their proprietary Exome+™ assay—a panel-grade exome enhanced by more than 300,000 informative non-coding regions—Helix offers health systems a scalable solution which enables the discovery of medically relevant, potentially life-saving, genetic information. Additionally, Helix offers a suite of DNA-powered products for continued individual engagement and discovery. Helix is headquartered in the San Francisco Bay Area and has one of the world’s largest CLIA-certified, CAP-accredited Next Generation Sequencing labs, located in San Diego, California. Learn more at www.helix.com. Helix, the Helix logo, and Exome+ are trademarks of Helix Opco, LLC. Gilead Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the parties may not realize the potential benefits of this collaboration, and Gilead may fail to discover, develop and commercialize any product candidates for the treatment of NASH. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Additional Media Contact: Sung Lee, Investors 650-524-7792 Arran Attridge, Media 650-425-8975
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Population Health Study Goes Statewide and Opens Enrollment
The study could expand to a quarter million people, making Nevada the only state in the U.S. to offer such a program. Las Vegas, Nev. (May 2, 2019) – The Healthy Nevada Project, a first-of-its-kind, community-based population health study combining genetic, clinical, environmental and social data, is expanding enrollment to Las Vegas. The Project aspires not only to offer genetic testing to every Nevadan interested in learning more about their health and genetic profile but ultimately, to develop and expand the Project for communities across the United States to drive positive health outcomes nationwide. Adding 25,000 Study Volunteers in Southern Nevada The Healthy Nevada Project is announcing a statewide expansion – opening 25,000 testing slots in Las Vegas. With southern Nevada welcoming the study, the Healthy Nevada Project will offer no-cost genetic testing through a simple spit sample to 25,000 study volunteers. Study volunteers will take Helix’s clinical-grade DNA saliva test and will receive their ancestry and traits, at no cost, through the My Healthy Nevada Traits app. Participants will then be given a chance to answer a follow-up health survey from Renown Institute for Health Innovation (Renown IHI), and upon survey completion, will be entered to win an iPhone. In addition, study participants can agree to be notified about genetic test results that could impact their health, and which could be used to improve their medical care. This return of clinical results, plus genetic counseling and other genetic services as appropriate, will be provided by Genome Medical, the leading network of clinical genetics specialists. Healthy Nevada Project’s Evolution & Ongoing Expansion With more than 35,000 study participants enrolled in just over two years, the Healthy Nevada Project has become the fastest-enrolling genetic study in the country. The Project was created by Renown IHI – a collaboration between Reno, Nev.-based not-for-profit health network, Renown Health, and the world leader in environmental data, Desert Research Institute (DRI). Leveraging Renown’s forward-thinking approach to community health care and DRI’s data analytics and environmental expertise, Renown IHI has grown its capabilities to lead a larger, more complex research study of significance that will analyze and model public health risks in Nevada and serve as a national model for future population health studies working to improve overall health through clinical care integration. During the Project’s pilot launch in September 2016, more than 10,000 community members signed up for DNA testing in just 48 hours. In March 2018, phase two offered full genomic sequencing through a simple spit test from Helix to northern Nevadans. In October 2018, the Project announced the return of clinical results for study participants, notifying them of their risk for CDC Tier 1 conditions including familial hypercholesterolemia, BRCA positive 1 and 2, and Lynch syndrome, a precursor to colon cancer. These conditions affect more than one percent of the population and are inherited so they impact family members as well. Now, the Project announced its next phase – expanding enrollment to 25,000 people in southern Nevada. Serving as a National Model This expansion to Las Vegas truly makes this the “Healthy Nevada Project” with a statewide impact making Nevada the only state in the U.S. to offer such a program. “Nevada was ripe to advance population health goals because, sadly, our state ranks near the bottom in health outcomes. The Healthy Nevada Project is working to change that,” said Anthony Slonim, M.D., DrPH, FACHE, president and CEO of Renown Health and president of Renown IHI. “Our researchers are working on a number of clinical programs and scientific studies to determine why in Washoe County, the county in which Renown Health is located, Nevada’s age-adjusted death rates for heart disease, cancer and chronic lower respiratory disease are 33 percent higher than the national rate. Imagine if we can gather more data like this on a national scale and use it to change the future of health and health care? That is what the Healthy USA Project is looking to do in the years to come.” “The Healthy Nevada Project is committed to providing study participants clinically actionable data that will help improve their health,” said Joseph Grzymski, Ph.D., associate research professor at DRI, principal investigator of the Healthy Nevada Project and chief scientific officer for Renown Health. “We are providing this information at the individual level so study volunteers can make lifesaving changes to reduce their risk. We’re also doing it on the community level to develop leading-edge research on health determinants for entire neighborhoods, states and eventually, the country.” Expanding to Become the Healthy USA Project The accelerated speed of the Project is made possible thanks to the ever-decreasing cost of sequencing. Today, Helix is able to sequence an entire exome – which allows reporting on most actionable genomic knowledge – for a fraction of what it would have cost just 10 years ago. Additionally, advances in digital health mean Helix and Project researchers can capture unprecedented amounts of health data digitally, making significant contributions to advancing precision health. The partnership has managed to remove the traditional barriers of population health studies, including the difficulty in recruiting participants, establishing quality high through put lab systems, and scaling interpretation and return of results. This development will be key as other health systems around the country join the Project. “We are thrilled to see the constant, fast-paced evolution of this Project with Renown IHI,” said Justin Kao, CoFounder of Helix. “In less than a year, we have sequenced the DNA of thousands of study participants and are now preparing to offer this incredible study in other states. Combining environmental, clinical, social and genetic data allows us to discover risk factors within communities and help people take action to live longer, healthier lives. That’s what makes the next step of the Healthy USA Project so exciting for all of us. ”Full details on study’s evolution and southern Nevada enrollment will be revealed at a press event in Las Vegas on Tuesday, May 7 at 3 p.m. Renown Institute for Health Innovation Renown Institute for Health Innovation is a collaboration between Renown Health - a locally governed and locally owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California; and the Desert Research Institute - a recognized world leader in investigating the effects of natural and human-induced environmental change and advancing technologies aimed at assessing a changing planet. Renown IHI research teams are focused on integrating personal healthcare and environmental data with socioeconomic determinants to help Nevada address some of its most complex environmental health problems; while simultaneously expanding the state’s access to leading-edge clinical trials and fostering new connections with biotechnology and pharmaceutical companies. Learn more at https://healthynv.org/. Helix is a genomics company with a simple but powerful mission: to empower every person to improve their life through DNA. Our affordable, turnkey population health solution enables institutions to quickly scale projects that engage communities and accelerate research and discovery, ultimately allowing every person to benefit from the power of genomics. We've also created the first marketplace for DNA-powered products where people can explore diverse and uniquely personalized products developed by high-quality partners, providing powerful tools to increase engagement and speed the pace of population-scale genomics. Helix is headquartered in the San Francisco Bay Area, has an office in Denver, Colorado and operates a CLIA-certified and CAP-accredited next-generation sequencing lab in San Diego powered by Illumina (NASDAQ: ILMN) NGS technology. Helix was created in 2015. Learn more at www.helix.com. Helix, the Helix logo and Exome+ are trademarks of Helix Opco, LLC. All other trademarks referenced herein are the property of their respective owners. Additional Media Contacts: Tracy Bower DRI 702-862-5404 media@dri.edu Eric Schubert Seismic for Helix 415-939-4366 press@helix.com
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Three Emergency Room Options for You and Your Family
Renown Health has three emergency rooms open 24 hours a day, seven days a week, ready to serve our community. We checked in with Amy Hawkins, Manager of Clinical Nursing at Renown South Meadows, to learn more about the emergency room experience and how each can accommodate your emergency care needs. 1. Renown Regional Emergency Room The emergency room at Renown Regional Medical Center is the only Level II Trauma Center between Sacramento and Salt Lake City, treating more than 80,000 ER and trauma patients annually. Services Offered: This location offers immediate emergency care covered by general surgeons and coverage by the specialties of orthopedic surgery, neurosurgery, anesthesiology, emergency medicine, radiology and critical care. In addition, tertiary care needs include cardiac surgery, hemodialysis and microvascular surgery. (Patients may be referred to a Level I Trauma Center.) Renown Regional ER Location 2. Renown South Meadows Emergency Room South Reno is expanding, and so is Renown South Meadows ER! Exciting transformations are happening across this campus, including the new 121,000-square-foot specialty care center and upgrades to the existing medical center—expanding care to our patients. Added benefits to the more intimate setting at South Meadows: Smaller ER also means more personal experience. The team traditionally has more time to spend with each patient at the bedside. A smaller campus means convenient parking, as the ER is just outside the front entrance; however, patients are reminded to follow marked road signs when approaching the campus during construction. Most patients arrive by private vehicle versus an ambulance, so we are very accustomed to thinking quickly on our feet. Benefits to new construction: A new Cath lab will allow us to treat patients experiencing a heart attack and needing immediate intervention to open vessels in their hearts. Additional lab and imaging capabilities for our patients Services Offered: This location offers immediate emergency care staffed with board-certified emergency physicians. Patients can expect one-on-one interactions with trusted providers and shorter wait times. All emergency room services are open during construction, and patients are reminded to follow marked road signs when approaching the campus. South Meadows ER Location 3. Renown Children's Hospital Emergency Room This location offers immediate emergency care, with pediatric specialists always on staff. In addition, the Children's ER lobby is ideal for our littlest patients, with a child-friendly atmosphere and vibrant colors to help decrease the anxiety accompanying emergencies. Medical equipment is sized just for kids, and we offer a distraction machine, games and movies to help children cope with what can be a traumatic experience, like getting an IV. In addition, we have Child Life Specialists available to provide emotional support to both children and their families. When to Bring Your Child to the ER: Allergic reactions Asthma attacks Baby under three months old with a temperature higher than 100.4 degrees Fahrenheit Broken bones Burns Choking or poisoning Difficulty breathing Eye injuries Fainting, dizziness and confusion Head injuries Heart attack Rashes Seizures Severe bleeding Severe headache Severe pain Skin infections Stitches Stroke Venomous stings and bites Renown Children's Hospital Location
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Clinical Research: Advancing Healthcare in Northern Nevada One Study at a Time
Did you know that the Renown Research Office has partnered with the University of Nevada, Reno School of Medicine Clinical Research Office to form the Integrated Clinical Research Office? This means we are able to provide more clinical research opportunities and expertise to our northern Nevada community than ever before. Over the past two years, we have significantly expanded our clinical trial offerings from 35 to 101 studies to meet the healthcare needs of our community members and keep care options local. Currently, we offer clinical research as a care opportunity in areas such as cardiology, pulmonology, endocrinology, oncology, pediatrics, neurology and immunizations. What is Clinical Research? Clinical research is simply medical research that involves human volunteers (participants). Research studies have to be reviewed and approved by ethics committees to ensure that the questions researchers want to answer are appropriate and that research participants are protected throughout the study. Often when we talk about clinical research, we are referring to a clinical trial. Clinical trials are a type of clinical research study that places research participants into groups to study the safety and effectiveness of new medications and devices on a specific health outcome. Clinical trials follow rigorous standards and must pass four phases of testing, where each phase works progressively to understand the correct dosing and effects in larger and more diverse groups of people. Why is Clinical Research Important? Did you know that all medications, diagnostic tests and medical devices prescribed and used today by physicians and health practitioners were once tested in clinical trials? Clinical research advances medical care by helping us understand how to prevent disease and to provide new and better treatments for a wide range of health conditions. At Renown Health, we know the importance of offering the latest opportunities in healthcare, especially when standard of care options have been exhausted. What Are Some Considerations for Participating in Clinical Research? Research volunteers are often drawn to participating in studies because they are interested in accessing the latest health care treatments and/or they want to contribute to scientific discovery. If you are interested in becoming a research volunteer, you should first make sure you fully understand what the study and researcher is asking you to do and consider whether you are comfortable with the study activities and commitments to time and travel such as for required study appointments. Remember, participating in a research study is completely voluntary. That means you choose whether to participate, and you can choose to stop participating in a research study at any time, for any reason. Where Can I Find More Information About Clinical Research? There are many resources you can access if you have questions or want to learn more about clinical research. Your healthcare provider can assist you in your healthcare journey by discussing care options and exploring if participating in a clinical trial may be right for you. The Nevada Division of Public and Behavioral Health recently launched their Clinical Trials Info for Nevadans webpage which provides information on finding clinical trials in Nevada, understanding the importance of diversity in clinical trials, and linked resources to learn more about clinical trials. The U.S. Department of Health and Human Services Office for Human Research Protections provides informational videos, questions to ask researchers prior to participating and information on regulations in place to protect research participants. Finally, at the Renown Research Office, we are always here to support your clinical research journey and can be reached at Renown-CRD@renown.org or 775-982-3646. At Renown Health, our goal is to make it easy for patients to access clinical research as a care opportunity where patients can access a variety of standard care treatment options for their health condition or choose to participate in a clinical trial. For more information about clinical trial opportunities available to you or to ask any questions, contact the Renown Research Office at Renown-CRD@renown.org or 775-982-3646.
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