News Article | February 14, 2017
ROCKVILLE, Md., Feb. 14, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform, today announced the Investigational New Drug application (IND) is active for the planned multi-center, open-label, multiple-cohort, dose-escalation Phase I clinical trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD). “The goal of the RGX-314 program is to develop a single-dose treatment for wet AMD that prevents future disease recurrence while reducing or eliminating the need for regular injections that are the current standard of care in wet AMD,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We are on track to meet our next program objectives for RGX-314, beginning with trial enrollment by mid-2017 and an interim trial update by the end of the year, and we look forward to working with leading U.S. researchers and retina surgeons on this novel clinical program.” RGX-314 is being developed under a multi-institutional collaboration with world-renowned gene therapy and ophthalmology experts James M. Wilson, M.D., Ph.D., Jean Bennett, M.D., Ph.D. and Albert Maguire, M.D. from the University of Pennsylvania’s Gene Therapy Program and Center for Advanced Retinal and Ocular Therapeutics (Penn), respectively, and Peter Campochiaro, M.D. at the Johns Hopkins Wilmer Eye Institute (Johns Hopkins). “In animal studies, treatment with RGX-314 gene therapy led to rapid and sustained anti-VEGF protein detected in the eyes of treated animals. Preclinical studies have shown anti-VEGF mRNA and protein distributed widely throughout the retina. This high protein expression observed using RGX-314’s NAV AAV8 vector may make this approach suitable for an ocular therapeutic in wet AMD,” said Dr. Maguire. Six leading retinal surgery centers across the United States, including Penn and Johns Hopkins, are expected to participate in the Phase I trial of RGX-314. About the Phase I Clinical Trial of RGX-314 RGX‑314 will be evaluated in a Phase I, multi-center, open-label, multiple-cohort, dose‑escalation study in adult subjects with wet AMD in the United States. The study is expected to include approximately eighteen previously treated wet AMD subjects that are responsive to anti-vascular endothelial growth factor (anti-VEGF) therapy and are 50 years of age or older. The study is designed to evaluate three doses of RGX-314 (3 × 10^9 genome copies (GC)/eye, 1 × 10^10 GC/eye, and 6 × 10^10 GC/eye). Primary endpoints include adverse events, certain laboratory measures (including immunological parameters) and ocular examinations and imaging (including BCVA and SD‑OCT). The primary purpose of the clinical study is to evaluate the safety and tolerability of RGX-314 at 24 weeks after a single dose of RGX-314 administered by subretinal delivery. Following completion of the primary study period, it is expected that subjects will enter the follow-up period and will continue to be assessed until week 106 to assess long term safety and durability of effect. Wet AMD is characterized by loss of vision due to excess blood vessel formation between two layers of cells in the retina, which results in fluid leakage that can result in physical changes in the structure of the retina and changes in vision. Wet AMD is a leading cause of total and partial vision loss in the United States, Europe and Japan and there may be over two million individuals living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to halt or significantly impede the loss of vision in the majority of patients with wet AMD. All of these therapies, however, require repetitive and inconvenient intraocular injections, typically ranging from every four to eight weeks in frequency, to maintain efficacy. Patients often experience vision loss with reduced frequency of treatment. RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD that includes the NAV AAV8 vector encoding a gene for a monoclonal antibody fragment. The expressed protein is designed to neutralize VEGF activity, modifying the pathway for formation of new leaky blood vessels and retinal fluid accumulation. In preclinical animal models with conditions similar to macular degeneration, significant and dose-dependent reduction of blood vessel growth and prevention of disease progression was observed after a single subretinal dose of RGX-314. REGENXBIO is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy. REGENXBIO’s NAV® Technology Platform, a proprietary AAV gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO’s mission is to transform the lives of patients suffering from severe diseases with significant unmet medical need by developing and commercializing in vivo gene therapy products based on REGENXBIO’s NAV Technology Platform. REGENXBIO seeks to accomplish this mission through a combination of internal development efforts and third-party NAV Technology Platform Licensees. REGENXBIO and its licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas. Penn has licensed certain Penn-owned AAV technologies to REGENXBIO, including rights related to RGX-314. Dr. Wilson is an advisor to REGENXBIO, and is a founder of, holds equity in, and receives grants from REGENXBIO. This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, REGENXBIO’s research, development and regulatory plans and objectives for its RGX-314 program, including REGENXBIO’s Phase I clinical trial of RGX-314. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could cause actual results to differ materially from those projected by such forward-looking statements. All of REGENXBIO’s development timelines, including for RGX-314, could be subject to adjustment depending on recruitment rate, regulatory agency review and other factors that could delay the initiation and completion of clinical trials. Meaningful factors which could cause actual results to differ include, but are not limited to, the timing of enrollment, commencement and completion of REGENXBIO’s clinical trials; the timing and success of preclinical studies and clinical trials conducted by REGENXBIO and its development partners; the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize REGENXBIO’s product candidates, the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing REGENXBIO’s product candidates; competitive products; REGENXBIO’s ability to obtain and maintain intellectual property protection for REGENXBIO’s product candidates and technology; trends and challenges in REGENXBIO’s business and the markets in which REGENXBIO operates; REGENXBIO’s ability to attract or retain key personnel; the size and growth of the potential markets for REGENXBIO’s product candidates and the ability to serve those markets; the rate and degree of market acceptance of any of REGENXBIO’s product candidates; REGENXBIO’s ability to establish and maintain development partnerships; REGENXBIO’s expenses and revenue, the sufficiency of REGENXBIO’s cash resources and needs for additional financing, regulatory developments in the United States and foreign countries, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which are available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2016, to be filed in the first quarter of 2017. In addition to the risks described above and in REGENXBIO’s filings with the SEC, other unknown or unpredictable factors also could affect REGENXBIO’s results. There can be no assurance that the actual results or developments anticipated by REGENXBIO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, REGENXBIO. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. REGENXBIO cautions investors not to rely too heavily on the forward-looking statements REGENXBIO makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). REGENXBIO undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
News Article | March 1, 2017
Results of a small study of adults with autism at Johns Hopkins has added to evidence that their brains can learn to compensate for some language comprehension challenges that are a hallmark of the disorder in children. Studies analyzing electrical activity in the brains of children with autism have shown that they have difficulty sorting out pairs of words that are unrelated -- like "clock" and "frog" -- from those that are related -- like "baby" and "bottle" -- making it hard for them to process written or spoken language. Moreover, investigators believed that for most children with autism, this struggle with language persisted throughout their lives. Results of the new research from specialists at Johns Hopkins Medicine, published in the March issue of the Journal of Autism and Developmental Disorders, suggests that at least some adults with autism process unrelated words as well as adults without the disorder and their brains use distinct learning strategies to do so. "There is often an assumption that people with autism will always have problems understanding the meaning of language," says Emily Coderre, Ph.D., a postdoctoral fellow in neurology at the Johns Hopkins University School of Medicine. "But our results suggest that adults with autism seem to use an alternative mechanism to process language that results in a different pattern in the brain." For the study, the researchers recruited 20 adults with autism spectrum disorder, considered mild to moderate. All participants had "normal" verbal abilities, according to standardized tests. Those with autism spectrum disorder were diagnosed by a specialist on the team based on their score on the Autism Diagnostic Observation Schedule. Some participants were diagnosed early in life, and others not until adulthood. Many participants went to regular schools with special education tracks. Some participants had graduated high school, and some went through college. The research team also recruited a matching group of 20 participants without autism to serve as a comparative control group. Participants overall ranged in age from 18 to 69. Six were female, 35 were white, one was Asian, two were African-American, one was Hispanic and one was mixed race. All participants completed a 90-minute computer task that asked them to decide whether two pictures or two words were related (e.g., baby and bottle) or unrelated (e.g., frog and clock). The task designers chose 400 pairs of tangible nouns, half of them in the form of words and the other half displayed as pictures. One hundred of the noun pairs were related words, 100 were related pictures, 100 were unrelated words and 100 were unrelated pictures. The screen showed a picture or a word for 1 second and after a brief pause displayed the second picture or word. While the participants completed the task, the researchers monitored their brain's electrical activity using an electroencephalogram (EEG) that recorded activity from 256 electrodes. For their analyses, the researchers looked at the brain activity from nine small clusters of electrodes on the front left, middle and right of the head over the frontal cortex; in the left, middle and right of the top of the head over the central brain; and on the left, right and middle part of the back top of the head, where the parietal lobe is located. When analyzing unrelated pictures or words, people with typical development have a spike on the EEG during the 200- to 800-millisecond window following the second word or photo, known as an N400 response. Researchers believe the N400 response reflects the brain's ability to recognize that something is "off" and that two words or pictures aren't related in a meaningful way. When looking at related and unrelated pictures, the people with autism had the same N400 spike on the EEG readout as the people without autism. Contrary to findings from earlier studies in children with autism, adults with autism also had the N400 spike in electrical activity on the EEG when looking at related and unrelated words. In the controls, the response occurred at 250 to 500 milliseconds in the front of the head and from approximately 400 to 800 milliseconds over the top and top rear of the head. The response in the adults with autism started later, from 400 to 800 milliseconds in both the top and top rear of the head. From 400 to 800 milliseconds, the N400 spike was relatively evenly distributed over left and right sides of the head for the control participants, whereas in adults with autism, the spike was stronger over the right side of the head. Coderre says that these differences between the groups -- an earlier onset of the N400 response for controls and a more right-sided N400 response for the adults with autism -- suggest that the two groups used different strategies to think about the meaning of the words. She points out that overall, the adults with autism showed a similar N400 response to the controls, suggesting that they weren't impaired at teasing apart the unrelated from the related words, contrary to previous studies in children with autism. "It appears that although the adults with autism in our study have brains that are 'wired' differently than those without autism, our findings strongly suggest this different wiring can still enable them to achieve good cognitive and language abilities, at least on this one measure," she says. "It is possible that some adults with mild or moderate forms of autism may have developed compensatory learning strategies that allow them to process language as well as people without autism," says Coderre. She plans to repeat this experiment in children with mild to moderate autism to verify that the differences seen between adults and children are due to learned responses. "If we can understand those compensatory strategies better, then teachers can use this information in language programs for children or those with more severe language deficits to help them develop these alternative strategies faster and earlier," she adds. "I hope our study sends a hopeful message to people with autism or their parents." Coderre says that one limitation of her study is that they used single words for their analysis, simplifying it, whereas others in previous studies used full sentences in their study design, which may have affected the results. She also points out that they asked participants to think about whether the two words were related or not, which may have prompted them to use more explicit compensatory strategies. In future studies, she plans to repeat this experiment using an "implicit" task, in which participants aren't told to think about the relationship between the words, allowing her to verify whether these results were due to learned compensatory strategies in adults with autism. About 3.5 million people in the U.S. have autism, according to the National Institutes of Health, and about a quarter of those are nonverbal. Those with speech have difficulty with complex language processing, like understanding meaning, emotional states in the voice or metaphors. Additional authors on the study include Mariya Chernenok, Barry Gordon and Kerry Ledoux of The Johns Hopkins University. The study was funded by grants from the Therapeutic Cognitive Neuroscience Fund and the Benjamin and Adith Miller Family Endowment on Aging, Alzheimer's, and Autism Research.
News Article | February 23, 2017
Fracking, or drilling for gas by hydraulic fracturing, has been associated with a growing number of health risks. Last week, I began this series looking at some of the hazardous chemicals injected into the wells to make drilling easier and cheaper, and the growing risks to our health by the GOP rushing through the approval of Scott Pruitt to head the Environmental Protection Agency (EPA). This post looks in greater depth at the health problems linked to fracking. These are not hypothetical concerns—there are now more than 700 studies looking at risks—and more than 80% of the health studies document risks or actual harms. It’s also important to note that these risks are likely to be seriously underestimated, because the environmental agencies have been downplaying the risks to the public. A new in-depth exposé from investigative journalists at Public Herald looks in-depth at the Pennsylvania Department of Environmental Protection’s (DEP) misconduct and negligence, as the DEP studiously ignored citizens’ complaints, sometimes not even testing water samples. Earlier studies from ProPublica and others showed similar EPA failures in the western U.S. A variety of health problems are associated with fracking Cough, shortness of breath and wheezing are the most common complaints of residents living near fracked wells. Toxic gases like benzene are released from the rock by fracking. Similarly, a toxic waste brew of water and chemicals is often stored in open pits, releasing volatile organic compounds into the air. These noxious chemicals and particulates are also released by the diesel powered pumps used to inject the water. An epidemiological study of more than 400,000 patients of Pennsylvania’s Geisinger clinic, done with Johns Hopkins School of Public Health, found a significant association between fracking and increases in mild, moderate and severe cases of asthma (odds ratios 4.4 to 1.5). Hopkins’ Dr. Brian Schwartz cautions that residents should be aware of this hazard as “some ‘pristine’ rural areas are converted to heavily trafficked industrial areas.” Fracking chemicals are harmful to pregnant women and their developing babies. West Virginia researchers found endocrine-disrupting chemicals in surface waters near wastewater disposal sites; these types of chemicals can hurt the developing fetus even when present at very low concentrations. Another Hopkins/Geisinger study looked at records of almost 11,000 women with newborns who lived near fracking sites and found a 40% increased chance of having a premature baby and a 30% risk of having the pregnancy be classified as “high-risk,” though they controlled for socioeconomic status and other risk factors. Contributing factors likely include air and water pollution, stress from the noise and traffic (1,000 tankers/well on average). Premature babies accounted for 35% of infant deaths in 2010. In addition to the personal toll on the families, preemies are very expensive for society—prematurity is a major cause of neurologic disabilities in kids, and their cost of care was more the $26 billion in 2005 alone, or $51,600 per preemie. Cost to employers during the infant’s first year of life averaged $46,004—more than tenfold higher than for a full-term delivery. [Note that if the Affordable Care Act is repealed, women may once again be denied health insurance for pregnancies and a premature baby will likely never be granted health insurance. According to the March of Dimes, Medicaid expansion of health insurance to low-income citizens helped the percentage of babies born as preemies drop to a low level of 11.4% in 2013.] Other studies have found that the noise from the drilling itself, the gas compressors, other heavy equipment and the truck traffic is high enough to disturb sleep, cause stress and increase high blood pressure. Longer-term exposure to noise pollution contributes to endocrine abnormalities and diabetes, heart disease, stress and depression, and has been linked to learning difficulties in children. Sleep deprivation has pervasive public health consequences, from causing accidents to chronic diseases. Another epidemiologic study from University of Pennsylvania and Columbia University compared the hospitalization rates between a county with active fracking and a neighboring county without. This study found that fracking well density was significantly associated with higher inpatient hospitalization for cardiac or neurologic problems. There was also an association between skin conditions, cancer and urologic problems and the proximity of homes to active wells. With disturbing frequency, new spills or accidents are reported at the same time as industry tries to reassure that fracking brings safe and clean energy. Tell that to the residents of Dimock, Pa., who have had their drinking water destroyed, or those in many other communities. A newly released study found 6,648 spills in just four states over the past 10 years. Once again, the EPA had reported a far lower number—457 in eight states over a six-year period. Why the huge difference? Because the EPA chose to only look at the actual fracturing stage, rather than the whole life cycle of the gas and oil production. The DeSmogBlog notes that just this month, the day after U.S. Army Corps of Engineers gave the owners of the Dakota Access Pipeline (DAPL) the final permit it needed to build across Lake Oahe (threatening the Standing Rock Sioux tribe’s land and water), a pipeline of a DAPL co-owner exploded near New Orleans, killing one and injuring others. Aging pipelines pose special risks as they deteriorate. An ExxonMobil pipeline built in 1947 spilled 134,000 gallons of gas in Arkansas. You can see the location and magnitude of the spills at this handy interactive from the National Center for Ecological Analysis and Synthesis (NCEAS) Science for Nature and People Partnership (SNAPP). Another disturbing data viz shows the type of spill and whether water was impacted. But new fracking has additional risks, as the conventional pipes often used are unable to withstand the high pressure of the fracking mixture being injected. In fact, new wells were not safer, and 6% of unconventional (fracked) wells drilled since 2000 showed problems, with even the Pa. DEP (shown by Public Herald to not be thorough in investigating citizens' complaints, nor entirely forthcoming) confirming more than 100 contaminated drinking water wells. The oil and gas industry says that these health problems are not proven to be caused by fracking. That is partially true—especially since agencies like the Pa. DEP have actively hidden complaints or even failed to test the water of residents, as Public Herald reported. With the new head of the EPA, Scott Pruitt, determined to dismantle the agency and its protections, we will likely never have definitive proof. Some health problems, such as cancer and some neurologic problems, also take years to develop after an exposure. Fracking profits go to private industry but the public—families and communities—bear the costs of the many health complications from the drilling. There is growing evidence of a variety of health problems being associated with fracking. Common sense dictates that drinking and breathing cancer-causing agents will take their toll. The correlation is too strong to ignore, especially when we have other, cleaner energy options. For our safety and that of future generations, we should not allow the new administration to sell off public lands, nor allow drilling on our land, and should ban fracking completely. For more medical/pharma news and perspective, follow me on Twitter @drjudystone or here at Forbes
News Article | March 1, 2017
NAPLES, Fla.--(BUSINESS WIRE)--A new online forum for analysis and commentary, Analizir.com, has opened, announced Leslie Norins, MD, PhD, publisher at Medvostat LLC, its parent company. The debut analysis on the site, authored by Dr. Norins himself, claims the decline in print circulation of the “Big Three” national newspapers—Wall Street Journal, New York Times, and USA Today—can be reversed. He also presents his prescription for the turnaround. Smartphones and digital media are convenient villains, he says, because blaming them has diverted publishers‘ attention from necessary updating of print edition marketing. Dr. Norins believes reading the print edition of the Big Three marks a person as “substantial,” whereas a smartphone viewer could be consulting gossip, games, or even porn. “Print is positive, smartphones are iffy,” he says. He says one unsung advantage of the print edition page is its “glorious” display size, 264 square inches, versus the 13 square inches of his iPhone screen. Thus, print’s big page facilitates “serendipity,” which occurs when the reader’s peripheral vision unexpectedly notes nearby important, profitable articles on other subjects. He prescribes ads quoting millennials who benefit from the print edition, plus hiring “influencers” to tout the special advantages of this format. Dr. Norins also reports he found it difficult to find the Journal and Times on sale in Brooklyn, “in the backyard” of the Manhattan headquarters of the two papers. Dr. Norins has over 40 years’ publishing experience creating and growing over 80 subscriber-paid newsletters serving medical professionals. Before the publishing phase of his career, he was a physician-researcher. He received his AB from Johns Hopkins, his MD from Duke University Medical School, and his PhD from University of Melbourne, where he studied with Sir Macfarlane Burnet, Nobel Laureate.
News Article | February 21, 2017
The StayWell Company announced today that Krames CareEngageTM powered by Doctella now features a SMART on FHIR application. The SMART on FHIR application is available for testing with clients who use CareEngage for patient education and care management. StayWell will demonstrate the CareEngage solution during #HiMSS17 at booth 3443. CareEngage is an interactive platform that addresses real-world health needs, such as patient compliance and chronic conditions, by keeping patients better informed and engaged in their care. The platform is licensed by hospitals and health systems and can be integrated into EHR systems to improve patient safety, quality and compliance. SMART (Substitutable Medical Applications and Reusable Technologies) on FHIR (Fast Health Interoperability Resources) is a fast-growing and much-lauded technology that facilitates the connection of EHRs across health care provider organizations and allows patient education to be prescribed from, and tracked in the EHR. Effectively engaging patients and caregivers is essential to hospitals and health systems in new value-based payment models, because engagement — which can be fostered by interactive education, communications and positive feedback — can contribute to improved patient compliance and clinical outcomes under MACRA and MIPS. Earlier this month, early adopters of CareEngage met to discuss implementation strategies and use of the platform within their hospital business units and outlined targeted departments, processes and workflows that could be improved by CareEngage. These early adopters are part of the Krames CareEngage Collaborative, which will also assist in tracking metrics to measure platform usage and satisfaction. “Health care regulations are putting an increased focus on patient-centered and value-based care. Giving patients anytime-access to their health information and fostering communication between health care providers, patients and their families, encourages people to take a more active role in their care. In the long run, this will lead to better health and a more satisfying care journey for patients, and improved quality, safety and reimbursement for hospitals,” said Nicole Latimer, president, StayWell. CareEngage augments verbal instructions and print materials with state-of-the-art, customizable and interactive, multimedia tools that can be easily shared with family and caregivers. It is a unique application of quality improvement science and physician-developed Smartlists delivered in an open, interactive content framework that maps the complete patient journey, including: patient preferences, education, care instructions, symptom tracking, beliefs, belonging, insights and patient reported outcomes and measures. The addition of SMART on FHIR to the CareEngage solution will make the integration and use of the platform across provider locations efficient for both clinicians and patients. “SMART on FHIR is emerging as the new industry standard for patient-facing health technology solutions. It neutralizes potential issues related to platform compatibility across health systems and creates a user-friendly, seamless environment for patients and health care professionals,” said Amer Haider, CEO of Doctella. “The potential that this delivers to health systems across the country who use CareEngage is significant and timely to the pressing needs of our health care marketplace.” Existing StayWell customers can easily integrate CareEngage into their EHR workflow using the SMART on FHIR application. To learn more about CareEngage or to join the Krames CareEngage Collaborative, a cohort of early adopters established by StayWell, visit http://www.staywell.com/doctella. Follow and participate in the conversation on Twitter: #StayWellCareEngage #MedicalErrors #PatientSafety #PatientEngagement #Checklists #DoctellaChecklists #DigitalHealth #HealthApp #SMARTonFHIR #HIMSS17 About StayWell StayWell is a health solutions company that uses the science of behavior change to help people live happier, healthier lives. StayWell brings decades of experience working across the health care industry to design solutions for improving individual and organizational health outcomes, managing the health of targeted populations, and creating brand engagement for employers and health care organizations. StayWell programs have received numerous top industry honors, including the C. Everett Koop National Health Award and the Web Health Award for health engagement programs. StayWell also has received URAC and NCQA accreditation for several of its programs. StayWell is majority-owned by Healthcare Services & Solutions, LLC, a wholly owned subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (“Merck”). The company is headquartered in Yardley, Pennsylvania, and also has major locations in Salt Lake City, Utah, and St. Paul, Minn. To learn more, visit http://www.staywell.com. About Merck For over a century, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (http://www.sec.gov). About Doctella: Doctella.com, by Patient Doctor Technologies, Inc. and creators of Doctella Smartlist technology, is based in Silicon Valley. The company provides a comprehensive patient-centered outcomes management platform to improve the culture, communication, and engagement between patients, families, and providers. The Doctella Smartlist app was developed by leading researchers from Johns Hopkins and at other leading institutions. The StayWell Company, LLC, is an investor in Doctella. Start your journey to better, safer care at http://www.doctella.com.
News Article | February 20, 2017
Receive press releases from Mario Garita MP The Dental Experience: By Email San Jose, Costa Rica, February 20, 2017 --( “We want to ensure we communicate as clearly as possible with our patients on all levels, and provide a sense of security that only a U.S. National can convey to his/her own countrymen. I have long been bi-lingual, spent years in the United States studying and practicing dentistry, and I understand North Americans very well, but there is no substitute for a native; someone who understands the idiosyncrasies of the American culture and has a complete command of the English language.” He continued, “We have treated thousands of Dental Tourists over the past two decades and witnessed steady growth all along, but we believe the industry may soon begin to grow exponentially. We want to be well prepared for when that time comes. We know our Customers and Target Market very well, and we have the talent, equipment, facilities and experience required to handle nearly every dental case imaginable. Howard will ensure our Customer Service keeps pace with our clinical performance. “The industry is extremely segmented and offers many classes of service, but unlike other clinics, we have been defined over the years as an upscale Provider by our actions, not by our marketing. Our patients say we are the steak, not the sizzle. We agree. It is the experience we have gained and the steps we have taken over the years to refine our methodologies and clinical and lab processes which together comprise The Dental Experience; and it is that experience that keeps our Patients coming back year after year.” Siegler added, “After working for several other clinics in Costa Rica and having met most of the Dental Specialists in this marketplace, I can comfortably say that Dr. Garita is at the top of his field and the top of his game; especially when it comes to dental implant surgery and catering to Dental Tourists. There are few people I have met who are as passionate about Dental Tourism as I am, and Dr. Garita is definitely one of them. He lights up when he talks about three things: His Family, Dental Tourism and Dental Surgery; and those are the very same reasons I wanted to work with him.” Dr. Priscilla Rojas, D.D.S., Dr. Garita’s Founding Partner and wife, said: “Most everyone in the industry knows about the beautiful clinic we just built from ground up with the Dental Tourist in mind. Nothing has been left to chance. Yes, it is all part of The Dental Experience. And Howard will make an excellent addition to our Team and to the 'Experience.'” While no one can clearly identify the first Dental Tourist who travelled to Costa Rica, there is a very strong chance that Dr. Garita was behind the mask treating that patient. He is often cited as the “Father of the All-on-4 dental implant solution (in Costa Rica)”, one of the clinic’s most popular offerings, but he may actually be the “Father of Dental Tourism” altogether. Siegler said: “When I began working in this industry more than 5 years ago, I would have never imagined I would be working side by side with the best in the business and at the original Dental Tourism clinic in Costa Rica! “This is an exciting way to start 2017 and I certainly look forward to working with Dr. Garita and his Team. I frequently ask Dentists in Costa Rica whom they would want to have as a surgeon to place their dental implants if the need ever arose, and the response is nearly always 'Dr. Mario Garita.' I am very fortunate to have an opportunity to represent the best Dental Surgeon in Costa Rica and one of the best in the world. It will truly be a great privilege and an honor to serve as the clinic’s front line Representative.” About The Mario Garita Dental Experience: Dr. Mario Garita is well known as the Top Rated Dental Surgeon in Costa Rica. His Company, The Dental Experience entails an A to Z approach that ensures Patients are in EXPERT hands from start to finish. The Garita Team has treated nearly 5000 Dental Tourists and has successfully placed more than 25,000 dental implants. Dr. Garita has also completed more than 700 All-on-4 dental implant restorations which has earned him the designation as the Father of All-on-4 in Costa Rica. San Jose, Costa Rica, February 20, 2017 --( PR.com )-- Mario Garita, D.D.S., Founder and Director of The Dental Experience in Costa Rica announced Howard Siegler, Johns Hopkins M.B.A. as the Clinic’s International Patient Coordinator. Dr. Garita said: “We have known Howard for years and were very excited when he approached us about working together. We believe The Dental Experience we offer has long set the bar in Dental Tourism, and that Howard can help us continue in this tradition. We could not be more pleased with our decision to bring him into our Company.“We want to ensure we communicate as clearly as possible with our patients on all levels, and provide a sense of security that only a U.S. National can convey to his/her own countrymen. I have long been bi-lingual, spent years in the United States studying and practicing dentistry, and I understand North Americans very well, but there is no substitute for a native; someone who understands the idiosyncrasies of the American culture and has a complete command of the English language.”He continued, “We have treated thousands of Dental Tourists over the past two decades and witnessed steady growth all along, but we believe the industry may soon begin to grow exponentially. We want to be well prepared for when that time comes. We know our Customers and Target Market very well, and we have the talent, equipment, facilities and experience required to handle nearly every dental case imaginable. Howard will ensure our Customer Service keeps pace with our clinical performance.“The industry is extremely segmented and offers many classes of service, but unlike other clinics, we have been defined over the years as an upscale Provider by our actions, not by our marketing. Our patients say we are the steak, not the sizzle. We agree. It is the experience we have gained and the steps we have taken over the years to refine our methodologies and clinical and lab processes which together comprise The Dental Experience; and it is that experience that keeps our Patients coming back year after year.”Siegler added, “After working for several other clinics in Costa Rica and having met most of the Dental Specialists in this marketplace, I can comfortably say that Dr. Garita is at the top of his field and the top of his game; especially when it comes to dental implant surgery and catering to Dental Tourists. There are few people I have met who are as passionate about Dental Tourism as I am, and Dr. Garita is definitely one of them. He lights up when he talks about three things: His Family, Dental Tourism and Dental Surgery; and those are the very same reasons I wanted to work with him.”Dr. Priscilla Rojas, D.D.S., Dr. Garita’s Founding Partner and wife, said: “Most everyone in the industry knows about the beautiful clinic we just built from ground up with the Dental Tourist in mind. Nothing has been left to chance. Yes, it is all part of The Dental Experience. And Howard will make an excellent addition to our Team and to the 'Experience.'”While no one can clearly identify the first Dental Tourist who travelled to Costa Rica, there is a very strong chance that Dr. Garita was behind the mask treating that patient. He is often cited as the “Father of the All-on-4 dental implant solution (in Costa Rica)”, one of the clinic’s most popular offerings, but he may actually be the “Father of Dental Tourism” altogether. Siegler said: “When I began working in this industry more than 5 years ago, I would have never imagined I would be working side by side with the best in the business and at the original Dental Tourism clinic in Costa Rica!“This is an exciting way to start 2017 and I certainly look forward to working with Dr. Garita and his Team. I frequently ask Dentists in Costa Rica whom they would want to have as a surgeon to place their dental implants if the need ever arose, and the response is nearly always 'Dr. Mario Garita.' I am very fortunate to have an opportunity to represent the best Dental Surgeon in Costa Rica and one of the best in the world. It will truly be a great privilege and an honor to serve as the clinic’s front line Representative.”About The Mario Garita Dental Experience:Dr. Mario Garita is well known as the Top Rated Dental Surgeon in Costa Rica. His Company, The Dental Experience entails an A to Z approach that ensures Patients are in EXPERT hands from start to finish. The Garita Team has treated nearly 5000 Dental Tourists and has successfully placed more than 25,000 dental implants. Dr. Garita has also completed more than 700 All-on-4 dental implant restorations which has earned him the designation as the Father of All-on-4 in Costa Rica. Click here to view the list of recent Press Releases from Mario Garita MP The Dental Experience
News Article | February 15, 2017
February 14, 2017 - Nurses in all roles and specialties face complex ethical situations that challenge their values, giving rise to moral distress. New approaches to overcoming the challenges of moral distress by increasing moral resilience are presented in a supplement to the February issue of the American Journal of Nursing. The journal is published by Wolters Kluwer. Based on the proceedings of a recent expert symposium, the special report outlines strategies to mitigate the harmful effects of moral distress in the health care workforce and to create healthy work environments--with the goal of providing safe, high-quality care for patients and families. The supplement, titled "State of the Science: Transforming Moral Distress into Moral Resilience in Nursing," is now available on AJN's website. Cynda Hylton Rushton, PhD, RN, FAAN, and Kathy Schoonover-Shoffner, PhD, RN, are the guest editors of the special report. Moral distress occurs when nurses and others "recognize their responsibility to respond to care situations but are unable to translate their moral choices into action." For example, an oncology nurse may know that a cancer patient wishes to refuse treatment, but doesn't do so because his physician and family want him to "fight on"; or nurses on a geriatric unit may know they are not providing needed care to patients because of poor staffing. With the increasing complexity of health care, mortal distress in nursing has risen to unprecedented levels. These conflicts threaten nurses' core values and moral integrity, contributing to burnout and staff shortages and endangering safety and quality of care. At an invited symposium held in Baltimore last August, 46 nursing researchers, clinicians, ethicists and organization representatives met to discuss moral distress and to develop strategies to address it. Following a consensus process, the participants approved recommendations on essential steps for addressing moral distress and supporting the cultivation of moral resilience in individuals; and for building systems that support ethical practice. In both areas, priorities for education, practice, and policy are identified. The full supplement, including a concise executive summary, is freely available to read and download on AJN's website: http://journals. . The report can also be found in a digital magazine format at http://mydigimag. . The project was a four-year collaborative effort of The Johns Hopkins School of Nursing and Berman Institute of Ethics, the American Journal of Nursing, and the Journal of Christian Nursing, along with the American Association of Critical Care Nurses and the American Nurses Association. Funding support came from Johnson & Johnson, the Heilbrunn Family Foundation, and Nurses Christian Fellowship/USA. "We hope clinicians, administrators, educators, and researchers will use this report to initiate conversations, plan strategies and curricula, and conduct research toward creating effective ways to respond to situations that provoke moral distress," according to an introductory editorial by Maureen Shawn Kennedy, MA, RN, FAAN, Editor-in-Chief of American Journal of Nursing. The Editors voice the hope that the information presented will lead to new approaches to lessening the occurrence and harmful effects of moral distress. They write, "With determined action, we can help nurses and other providers mitigate the effects of moral distress, enhance the ethical environment in which they practice, and improve the quality of health care." About the American Journal of Nursing American Journal of Nursing is the most honored broad-based nursing journal in the world. Peer reviewed and evidence-based, it is considered the profession's premier journal. AJN's mission is to promote excellence in nursing and health care through the dissemination of evidence-based, peer-reviewed clinical information and original research, discussion of relevant and controversial professional issues, adherence to the standards of journalistic integrity and excellence, and promotion of nursing perspectives to the health care community and the public. Wolters Kluwer is a global leader in professional information services. Professionals in the areas of legal, business, tax, accounting, finance, audit, risk, compliance and healthcare rely on Wolters Kluwer's market leading information-enabled tools and software solutions to manage their business efficiently, deliver results to their clients, and succeed in an ever more dynamic world. Wolters Kluwer reported 2015 annual revenues of €4.2 billion. The group serves customers in over 180 countries, and employs over 19,000 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands. Wolters Kluwer shares are listed on Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices. Wolters Kluwer has a sponsored Level 1 American Depositary Receipt program. The ADRs are traded on the over-the-counter market in the U.S. (WTKWY). Wolters Kluwer Health is a leading global provider of information and point of care solutions for the healthcare industry. For more information about our products and organization, visit http://www. , follow @WKHealth or @Wolters_Kluwer on Twitter, like us on Facebook, follow us on LinkedIn, or follow WoltersKluwerComms on YouTube.
Agency: Department of Defense | Branch: Navy | Program: STTR | Phase: Phase I | Award Amount: 80.00K | Year: 2013
We propose a solution to the Navy"s laser weapons warning problem. The proposed solution employs a combined approach of extending the wavelength spectrum and dynamic range of current State of the Art laser warning systems. The proposed wide optical bandwidth will be achieved by adapting previously developed methods. The system will exploit on going design work created for visible multi-threat optical systems and leverage advances in FPA technologies. The optical bandwidth will require multiple diffraction gratings integrated with reflective wide FOV optics. FPA enhancements will address anticipated dynamic range requirements
News Article | February 19, 2017
Can Changing When And What We Eat Help Outwit Disease? I was worried that I might not be able to stick to an intermittent fasting schedule during my vacation in Mexico. It turns out, it was a breeze. It started on the plane ride to Cozumel, a tingle in my throat and then the telltale sign that illness was imminent: three sneezes in a row. A clogged nose, a slight fever and a general feeling of malaise came over me after my third dive into the electric blue waters of the Caribbean. I'm participating in a preliminary study at Johns Hopkins Medicine on the effects of intermittent fasting on the microbiome and inflammation in people with multiple sclerosis. For the six-month study, I'm restricted to eating during an eight-hour period, usually from noon until 8 p.m. That meant that the first day of vacation, my first meal was pretzels on a plane, my second was ceviche and nachos in the late afternoon. It wasn't a great combination, but I had a feeling that as my nose continued to clog, I wouldn't be able to taste much, so I went for variety. As the week went on, I tried not to let my inability to taste hamper the experience, but it was hard. Tacos tasted like rubber, plantains like Elmer's glue. And though I squealed in delight when I saw a churros cart, the deep-fried, buttery, cinnamon-sugary treats tasted more like cardboard covered in sawdust. My vacation was headed toward gastronomic disaster, but at least the study data would not be compromised. At the end of the six months, researchers will be looking at the state of my microbiome, via a stool sample, to determine how it may have changed. Or to be precise, my microbiota, according to Jorge Cervantes, an assistant professor of microbiology at the Texas Tech University Health Sciences Center, El Paso who has studied the microbiome in relation to several diseases, including MS. I called him to get up to speed on my microbiota. "The microbiota is all the microorganisms living in a specific niche," he says. That niche being my gut. "We talk about bacteria, mainly, but there are also viruses and fungi." The microbiome is the whole ecosystem — the bacteria, viruses, fungi, as well as the environmental conditions they inhabit. Our resident bacteria serve us in three basic ways, says Cervantes, who is not involved in the study I'm doing. They occupy space and help restrict the overgrowth of bad bacteria. And they can help our metabolism by facilitating the breakdown of certain molecules. Gut bacteria are of special interest to people with autoimmune diseases, including multiple sclerosis and Crohn's disease, because they help in the training and development of our immune systems. That's so that your immune system can sample a molecule and and tell, " 'Oh this is bacteria,' or 'Oh, this is a virus.' " Cervantes explains. If the molecule might cause harm, an immune response is triggered. Once an immune cell locates a potentially harmful molecule — say, from the bacteria Streptococcus, or whatever I caught on the plane to Mexico — it sends out a call to other immune cells so they can help control the invasion, Cervantes says. That process creates inflammation, which can involve pain, stinging, swelling or a host of other unpleasant symptoms that ordinarily mean your body is fighting the good fight to help you heal. "Sometimes," Cervantes said, "the immune cells get confused." And here's where our microbes can affect autoimmune diseases such as MS, in which the body's immune system fires up at the wrong times: Bacteria can be the trigger for this confusion. An immune cell can mistake good bacteria for bad bacteria, and that confusion can lead to an immune response when there's no real threat to a person's health. Scientists are not only studying microbiota and their relationship to autoimmune diseases; they're studying their roles in hypertension, cancer, even mental health disorders. Research in many of these areas is new and exciting and full of potential — and faces challenges, one being the difficulty of teasing out cause and effect. Does a change in the volume and/or variety of a microbiota lead to disease? Does the disease change the microbiota, leading to other health changes? "The thing is, no one knows what is first, the egg or the chicken," Cervantes says. To answer that question, scientists have been turning to mice. Not just any mice, these rodents are squeaky-clean, entirely germ-free. According to a review published in 2015 in Microbial Ecology in Health and Disease, germ-free mice are less likely to have inflammatory bowel disease, autoimmune arthritis, Type 1 diabetes and other autoimmune diseases. And when they do have them, the symptoms are less severe. This, the authors say, is consistent with the idea that the microbiota could be a trigger for these diseases. Good news, right? But they go on to say that attempts to identify exactly which organisms could be causing these diseases have failed. And even if we can agree that we want a "healthy" gut microbiome, what does that mean? "There is no ideal," Cervantes says. "The point is that the microbiome is not a fixed entity." It changes over time and is different from person to person. And so it seems we've added a third variable to the already complex interplay of genetics and the environment when considering health and disease. I'm pleased to report that my immune system, while it may be overactive, also does its job once in a while, fighting back the infection as I hunkered down in my hotel room in Mexico. While I recuperated, I read through comments on the first article I wrote about my experiences with this study. People shared their own attempts to tweak their diets as means to ease suffering from a host of diseases. I also read a lot of criticism about my diet: "Who do these people think they are?" I thought. I mean, ramen is delicious, tacos are a mainstay of my diet, and ice cream is pretty much perfect. Many people with MS do have foods that they know don't sit well with them; for me, one is pizza. Delicious pizza. After a few slices my hands and feet burn and I typically fall asleep within the hour. To be honest, my body isn't a fan of ice cream, either. And I can't say I felt great after that ramen. Halfway into the study, and I haven't felt much better overall. The first thing I do when I get home from work every day is still nap. I still grab my trusty ice pack from the freezer about once a week and clutch it for the soothing effect it has on my hands, and occasionally my feet. Don't worry; I wash it! So OK, maybe the commenters are on to something. It stands to reason that if when you eat can have a drastic impact on the microorganisms in your gut, then certainly what you eat must be important, too, right? "By all means," Cervantes said. My study isn't looking at the effect of particular foods on MS symptoms. But I must admit I've been eating much worse since the study began. Come noon, I am so focused on food that I inhale everything in sight, then forage for more. One co-worker frequently reminds us via email that he has Hershey's Kisses in his office. Another introduced me to Peanut Chews — she kindly always has a pack waiting for me in her desk drawer. The convenience store downstairs has granola bars for 75 cents! (And french fries for $1.50.) Most days I eat my typically healthy lunch (some haphazard mix of vegetables topped with last night's dinner protein) and before I've finished chewing the last bite, before I can rationally asses the state of my hunger, I'm out of my office looking for another food fix. There's another reason I've continued to eat like a madwoman during these past three months. Over the past year, I've deliberately lost a good amount of weight. Let's call it 35 pounds. Despite my unhealthy recent eating habits, believe it or not, I did it through an overhaul in my diet, cutting out most simple carbs and eating more vegetables and trading fat for muscle mass. And like so many women, I do still reflexively judge how healthy I am in part by how much I weigh. I lost a few pounds when I began the study, and no matter how much ice cream I shovel into my face, I haven't gained any of it back. I'm no doctor, but I'm fairly certain that just because my weight is stable, that doesn't mean I'm on a path to perfect health or a flourishing microbiome. And so for the second half of the study, I have resigned myself to a crazy idea, getting back to eating like a responsible human being. A person who cares about the well-being of the ecosystem I'm hosting: the bacteria, viruses and other little guys who call my gut home. Brandie Michelle Jefferson is a communications manager and freelance reporter who loves a good science story. She's on Twitter, too: @b_m_jefferson
News Article | January 19, 2017
Rude patients could alter the medical care they receive from their doctors, according to new research. After evaluating the performance of 39 neonatal intensive care unit teams, scientists concluded that being polite with the medical staff is essential in receiving better services. The research, published in the journal Pediatrics, concluded that parents should be very careful with their attitude when it comes to protecting their children's well-being. As part of the study, scientists evaluated the proficiency of the medical service when it comes to children with different health issues, ranging from severe respiratory distress to hypovolemic shock. The simulations of emergency situations were carried out by people with different types of behavior. As part of a workshop, there were two randomly assigned teams, representing the rude group or the control group (with neutral behavior). As part of the rude group, a patient's mother made different comments not related to the team's performance. Additionally, there were two more teams manifesting either a preventative (cognitive bias modification) or therapeutic intervention. According to the research, the teams which had the patients with rude behavior consistently performed worse compared with the control group, being deficient in all 11 of the study's criteria, among which are diagnostic and communication. "Rudeness has robust, deleterious effects on the performance of medical teams. Moreover, exposure to rudeness debilitated the very collaborative mechanisms recognized as essential for patient care and safety. Interventions focusing on teaching medical professionals to implicitly avoid cognitive distraction such as CBM may offer a means to mitigate the adverse consequences of behaviors that, unfortunately, cannot be prevented," concluded the research. The medical teams were deficient in properly doing their jobs in all five rudeness situations they were exposed to, and the negative effects of their rude patients' behaviors lasted throughout the rest of the day. "[Rudeness] is actually affecting the cognitive system, which directly affects your ability to perform. People may think that doctors should just 'get over' the insult and continue doing their job. However, the study shows that even if doctors have the best intentions in mind, as they usually do, they cannot get over rudeness because it interferes with their cognitive functioning without an ability to control it," noted Amir Erez, Ph.D., member of the research team. The situation assessed by the current research concerning the pediatric facilities is far from isolated. Another research, conducted by Johns Hopkins researchers, showed that more than a quarter of a million deaths can be attributed to medical errors every year in the United States. "The science of safety has matured to describe how communication breakdowns, diagnostic errors, poor judgment, and inadequate skill can directly result in patient harm and death. We analyzed the scientific literature on medical error to identify its contribution to US deaths in relation to causes listed by the CDC," noted the research. According to these studies, it is best for the patients not to manifest their rudeness, as even with the best intentions in mind, the medical staff will not be able to get over their cognitive biases and will be unable to perform their tasks as they should. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.