12/20/2017

Company News

<p>The Emmes Corporation today announced its participation in a three-year study testing the results of two different opioid treatment medications. The <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)3281…; target="_blank">research</a>, published in one of the world’s oldest and best known medical journals, concluded that for those able to begin treatment, both drugs are nearly equal in their safety and effectiveness. The National Institute on Drug Abuse (NIDA) funded the research.</p>
<p>In addition to providing data management and statistical support, Emmes served as the clinical coordinating center. This involved protocol development, pharmacovigilance, quality assurance, safety monitoring and regulatory support. The clinical trial occurred between 2014 to 2017 at eight community treatment programs across the U.S. A total of 570 patients participated, with each group followed for a 24-week period. </p>
<p>This is the first U.S. study providing comparative data on the two opioid treatment medications. A similar study, conducted in Norway, included far fewer patients who were required to complete detoxification and occurred over a shorter time period.</p>
<p>“Opioid addiction has emerged as one of the most critical public health issues,” said Dr. Anne Lindblad, Emmes president and chief executive officer. “The U.S. needs to continue to invest in education and prevention – to try to reduce opioid addiction in the first place. This and other studies being conducted now by our team at Emmes address a related concern: how to treat people already addicted and reduce the chances of relapse.” </p>
<p>The opioid study, characterized by the New York Times as “long awaited,” compared the most commonly prescribed opioid treatment medication, buprenorphine-naloxone (known as Suboxone) with extended-release naltrexone (known as Vivitrol). Suboxone is a partial agonist, which still activates opioid receptors, but less strongly, so that cravings and withdrawal symptoms are reduced. Vivitrol is an antagonist, which blocks the activation of opioid receptors and thus the feeling of euphoria. Patients who take Vivitrol must totally detoxify before starting treatment. The study found that Vivitrol patients who are able to overcome this “detox hurdle” have similar results to those taking Suboxone. The study considered factors such as cravings, adverse effects and relapse rates.</p>
<p>“The detox hurdle and other differences in characteristics and clinical management of the two treatments posed some challenges during the study design phase,” noted Dr. Jeanine May, one of the Emmes co-authors. “However, the study’s lead investigators valued and trusted each member’s expertise, and this helped ensure a well-designed and executed trial. John Rotrosen, the lead investigator, deserves credit for his collaborative leadership.” </p>
<p>Dr. Rotrosen, professor in the Department of Psychiatry at NYU School of Medicine, served as the senior author of the Lancet article. He was joined by Joshua D. Lee, MD, MSc, associate professor in the Departments of Medicine and Population Health at NYU School of Medicine, who was lead author. The team members cited in The Lancet article included a number of physicians and researchers at medical centers and treatment facilities across the U.S.</p>
<p>Seven Emmes employees were listed as co-authors: Jacquie King, MS; Robert Lindblad, MD; Abigail G Matthews, PhD; Jeanine May, PhD; Dagmar Salazar, MS; Dikla Shmueli-Blumberg, PhD; and Don Stablein, PhD.</p>
<p><strong>About Emmes</strong><br />
We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

12/07/2017

Company News

<p>The Emmes Corporation today announced its statistical and data management support of a clinical trial that offers new hope for children with cerebral palsy (CP). Stephen Wease and Dr. Beth Blackwell joined a team of prominent researchers from Duke University Medical Center to test whether umbilical cord blood would improve motor skills function in children suffering from the disorder. </p>
<p>According to Wease, Emmes project leader, “The phase II trial showed promising results, and we’re eager for the next phases of research to further our understanding of this encouraging new mechanism for treating children with CP.”</p>
<p>Cerebral palsy is the most prevalent childhood motor disorder. It is most often the result of an in-utero or perinatal brain injury, and the impact can range from mild motor skill limitations to severe mobility issues.</p>
<p>The research demonstrated improvements in motor function a year after the injection of a high dose of stem cells from a child’s own cord blood. Future research opportunities will address the benefit of multiple doses and the use of donor cells.</p>
<p>“Umbilical cord blood is widely viewed as a treatment option for diseases like cancer, and new research findings suggest it could have therapeutic value in promoting the formation of new neural connections and improving motor function in young children with CP,” said Dr. Joanne Kurtzberg, M.D., the senior author of the study and director of Duke’s Pediatric Blood and Marrow Transplant Program and the Robertson Clinical and Translational Therapy Program.</p>
<p>Emmes served as the Statistical and Data Coordinating Center for the clinical trial. </p>
<p>“We selected EMMES to provide these services because of their outstanding reputation and high quality of their work,” added Kurtzberg. “Given the novelty of the study, it was critical to have the best organization evaluating and interpreting the data.”</p>
<p>The Robertson Foundation and The Marcus Foundations funded the study.</p>
<p>According to Dr. Anne Lindblad, president and chief executive officer of Emmes, “We are proud to work with the outstanding team at Duke University Medical Center in identifying innovative therapies for children with CP. We look forward to continuing to unlock the potential of cord blood research.”</p>
<p><strong>About the Research</strong><br />
The <a href="https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm…; target="_blank">paper</a> was published in Stem Cells Translational Medicine.</p>
<p><strong>About Emmes</strong><br />
We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

08/02/2017

Company News

<p>The Emmes Corporation today announced that it was awarded a contract from the National Institutes of Health to support pediatric clinical trials sponsored by the National Institute of Child Health and Human Development (NICHD). Valued at nearly $70 million, the 10‐1/2 year contract will support the NIH’s effort to improve the labeling of drugs for pediatric use.</p>
<p>The company’s role as the data coordinating center involves study design, data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses.</p>
<p>“This is one of Emmes’ largest contracts,” noted Dr. Anne Lindblad, president and chief executive officer. “More importantly, it reflects the government’s confidence in our ability to support both NIH and the Food and Drug Administration in a broad mandate to protect the nation’s children by ensuring that the medicines are safe, effective and used in the proper doses.”</p>
<p>The Best Pharmaceuticals for Children Act was enacted in 2002 and subsequently reauthorized by the Food and Drug Administration (FDA) in 2007 and 2012. One of its goals involves conducting clinical trials and research for on‐ and off‐patent drug products meriting further study for children. NICHD activities are aimed at improving pediatric drug therapies through preclinical and clinical testing that lead to drug labeling change.</p>
<p>Most new drugs that have potential applications in pediatric care must be tested in children prior to receiving marketing approval in the U.S. However, the majority of previously approved drug therapies have not been labeled specifically for children and are used off‐label without adequate studies in children.</p>
<p>“This contract represents an ongoing, successful collaboration between NIH and the FDA,” said Lindblad. “Emmes’ long history in serving both agencies is especially useful, given the broad mission of updating drug labels appropriately to address the needs of children.”</p>
<p>She continued, “What is especially noteworthy about this project is that it does not target one specific disease but a wide population – infants, young children and teenagers. We’re proud to help bring accurate drug labeling to inform physicians, parents and caregivers.”</p>
<p>Emmes held the data coordinating center role in the previous contract with the NICHD, which ran from 2009 to mid‐2017.</p>
<p>About Emmes<br />
We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

05/17/2017

Company News

<p>Rockville, MD – May 17, 2017 – The Emmes Corporation today announced that Dr. Paul VanVeldhuisen, chief operating officer and principal investigator, co‐authored a study published by the Journal of the American Medical Association (JAMA). The study focused on the efficacy and safety of a commonly used, off‐label drug called Avastin in treating macular edema due to central retinal vein occlusion. The study also addressed how Avastin compared to another drug, Eylea, which has been approved by the FDA and is being used to treat the same disease.</p>
<p>The 2‐1/2‐year study with nearly 400 patients concluded that Avastin was as effective as Eylea in improving vision after six months of treatment. The cost of Avastin is $60 per dose compared to Eylea’s $1,850 per dose.</p>
<p>Macular edema resulting from central retinal vein occlusion is the second most common retinal vascular disease and can cause vision loss. An estimated 16 million adults worldwide are affected by retinal vein occlusion.</p>
<p>The research was sponsored by the National Eye Institute, part of the National Institutes of Health. The Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) was presented at the Association for Research in Vision and Ophthalmology conference in Baltimore, Maryland, on May 9, 2017.</p>
<p>According to Dr. VanVeldhuisen, this was the first large‐scale study ever conducted to evaluate the comparative effectiveness of these two drugs in patients with central retinal vein occlusion.</p>
<p>“I’d like to acknowledge the leadership of Drs. Ingrid Scott, Michael Ip and Barbara Blodi, who led the team in this important research,” he said. “It’s been an honor to work closely with these outstanding researchers.”</p>
<p>Dr. Anne Lindblad, president and chief executive officer of Emmes, noted, “We have a long history with the National Eye Institute and are proud of our contributions to ophthalmic research. We look forward to continuing to lead clinical trials that contribute to new, better and less expensive treatment options.”</p>
<p><strong>About Dr. Paul VanVeldhuisen</strong><br />
Dr. Van Veldhuisen joined The Emmes Corporation in 1993 and was Emmes’ principal investigator of the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) sponsored by the National Eye Institute. He has served as principal investigator for both government and privately funded research projects and has authored or co‐authored 70 papers since he joined the company. Dr. Van Veldhuisen was named a vice president in 2006 and was promoted to the newly created position of chief operating officer last year. He received the company’s Public Health Impact Award in 2013 for his team’s research on the safety of cesarean sections. He holds a Ph.D. in epidemiology from The George Washington University, an M.S. in biostatistics from the University of Washington, and a B.S. in mathematics from Calvin College.</p>
<p><strong>About Emmes</strong><br />
We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

05/03/2017

Company News

<p>Rockville, MD – May 3, 2017 – The Emmes Corporation today announced a contract spanning just over four years for a Phase 2 study of a Zika vaccine. The contract, valued at up to $27.6 million, expands the initial Phase 1 testing that began last year. This is the first-ever Phase 2 study for a Zika vaccine.</p>
<p>Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “The win is important because it expands our role in combating the Zika virus, a significant and enduring public health challenge.”</p>
<p>The clinical study is being conducted for the National Institute of Allergy and Infectious Disease’s Vaccine Research Center at the National Institutes of Health (NIH). The study, titled a Phase 2/2B, Randomized Trial to Evaluate the Safety, Immunogenicity and Efficacy of a Zika Virus DNA Vaccine in Healthy Adults and Adolescents, is being conducted in two parts.</p>
<p>In the first part, 90 healthy adults, 18-35 years of age, will be enrolled at Baylor College of Medicine and the Puerto Rico Clinical and Translational Research Consortium. In the second part, 2,400 healthy adults and adolescents, 15-35 years of age, that reside in Zika endemic or potential endemic regions will be enrolled in the U.S., Caribbean, South America and Central America.</p>
<p>Under the contract, Emmes will lead the data management, statistical, regulatory, and clinical monitoring efforts. The company currently supports the predecessor study, a Phase 1 trial that is testing the same Zika vaccine in 45 subjects.<br />
In addition to the Zika studies for the Vaccine Research Center, Emmes supports four other Zika clinical trials.</p>
<p>“Emmes is no stranger to being called into action in the fight against major world health threats,” said Dr. Lindblad. “Zika, Ebola and pandemic flu vaccines are some recent examples. We’re proud to be making a contribution to vaccine science and trying to reduce the risk of future epidemics.”</p>
<p><strong>About Emmes</strong><br />
We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

03/13/2017

Company News

<p>The Emmes Corporation today announced the highest revenues in its 40‐year history along with significant growth in its employee count. Revenues surpassed $90 million in 2016, and it employed 567 employees in its U.S. and international offices.</p><p>This is also the first time that Emmes has appeared on the Washington Business Journal’s top company lists. Emmes was the eighth largest women‐owned business in the Washington metropolitan area, according to the 2016 ranking. It was also included as one of the Washington<br />Business Journal’s Top 100 private companies in September, with recognition in a related <a href="http://www.bizjournals.com/washington/news/2016/09/16/meet-all-the-comp…; about the record number of new companies on the list.</p><p>“It’s an honor to be recognized as a top company in the Washington area,” noted Dr. Anne Lindblad, president and chief executive officer of Emmes. “Our growth reflects a commitment to building client relationships founded on collaboration and trust. As a result, we’re continuing to recruit scientists, statisticians and support staff, and this means even more opportunities for personal and professional development.”</p><p>Last year, Emmes was chosen as one of the best places to work in the greater Washington area. The Washington Post’s prestigious <a href="http://www.topworkplaces.com/frontend.php/regional-lists">Top Workplaces</a> list recognized organizations with the highest engagement ratings from their employees in a survey conducted by Workplace Dynamics. Emmes was one of only three biotechnology organizations on the list. The company also received a <a href="http://www.excellentworkplace.org/awards-workplace.html">Workplace Seal of Approval</a> from the Alliance for Workplace Excellence (AWE) for the second consecutive year.</p><p>“What we do at Emmes is support clinical trials and public health research for clients in government, corporate and non‐profit sectors,” Lindblad said. “Our work and our culture attract people who think about their work in the context of preventing disease and creating more effective treatment options. The recognition we’ve received this past year is the result of a great team of employees.”</p><p><strong>About Emmes</strong><br />We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at <a href="https://secure.emmes.com/emmesweb/">www.emmes.com</a>.</p&gt;

11/14/2016

Company News

<p>The Emmes Corporation today announced that a large team of scientists and health professionals including those from the company, LDS Hospital in Salt Lake City, Utah, Lovelace Biomedical Environmental Research Institute in Albuquerque, New Mexico, and the U.S. Army Medical and Materiel Development Activity at Fort Detrick, Maryland, have authored a series of papers summarizing significant research on traumatic brain injury in the military. </p><p>Dr. Anne Lindblad, biostatistician and Emmes president and chief executive officer, and Dr. Steffanie Wilson, Emmes biostatistician, collaborated with principal investigator Dr. Lindell Weaver of the Hyperbaric Medicine Department of LDS Hospital, as well as Susan Churchill and Kayla Deru, also of LDS Hospital. Representing the funding organization of the study, the Hyperbaric Oxygen Project Management Office of the U.S. Army Medical and Materiel Development Activity, were Col. Scott Miller, Col. Austin Chhoeu, Capt. Brett Hart and Capt. Leonard Skipper. </p><p>According to Dr. Weaver of LDS Hospital, “These papers addressed the baseline findings of one of the most complex clinical trials of hyperbaric oxygen, which is being investigated as a potential intervention for post‐concussive symptoms following mild traumatic brain injury in a military population.” The study, sponsored by the Department of Defense, addressed both active duty and veterans in the military who suffered from mild traumatic brain injuries. </p><p>He added, “Even though our study was directed to military personnel, its results will be applicable to people outside the military, such as victims of sports injuries and car accidents who have suffered from mild traumatic brain injuries.” </p><p>Hyperbaric oxygen therapy is often associated with the treatment for carbon monoxide poisoning, as well as decompression sickness, which can result from scuba diving. Under hyperbaric oxygen therapy, a person inhales 100 percent oxygen in a total body chamber. </p><p>Dr. Wilson of Emmes explained that this study differed from those in the past both in duration of follow‐up activities with the participants and a more comprehensive battery of assessments in such groups as visual, audiological, neurological, neuropsychological and neuroimaging. “A key purpose of our research was to understand how the study population performed on these assessments to help select endpoints for related clinical trials in the future,” she said. </p><p>“The papers we wrote for the Undersea and Hyperbaric Medicine Journal addressed baseline data from the clinical trial,” she continued. “We appreciate the combined efforts of the study team and all of the authors of the papers. We expect to produce a series of additional manuscripts on post‐intervention findings.” </p><p>Dr. Lindblad, president and chief executive officer of Emmes, said, “We hope this research will be the cornerstone of an expanded opportunity for exploring more effective treatment for brain injuries and potentially post‐traumatic stress disorder. This is a perfect example of the benefits of scientific collaboration.” </p><p><strong>About the Research</strong><br />The papers were published in a special edition of the <a href="https://www.uhms.org/publications/uhm-journal/purchase-uhm-journal-v43-… and Hyperbaric Medicine Journal</a> this month. Non‐subscribers can access the papers for a nominal fee. </p><p><strong>About Emmes</strong><br />We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at www.emmes.com. </p>

02/08/2016

Company News

<p>The Emmes Corporation today announced that Dr. Paul VanVeldhuisen has been promoted to the newly created position of chief operating officer. Dr. VanVeldhuisen, who started at Emmes as a statistician and epidemiologist, will assume the additional leadership responsibilities while continuing to serve as principal investigator for government and privately funded research projects. </p>
<p>Dr. VanVeldhuisen joined the company in 1993 and was promoted to vice president in 2006. He is responsible for the scientific aspects of various research studies, including study design and analysis, and he oversees day-to-day operations of clinical trial support. Dr. VanVeldhuisen has contributed to research in important public health areas, including ophthalmology, drug abuse, organ transplantation and infectious disease. He also received the company’s Public Health Impact Award in 2013 for his team’s research on the safety of cesarean sections.</p>
<p>“I’m looking forward to my new role,” noted Dr. VanVeldhuisen. “What has stayed consistent during my 22 years here is our commitment to provide critical services that address important issues in public health. We’re involved in long-term studies on childhood cancer, clinical trials of HIV vaccines, vaccine trials associated with a pandemic threat, studies aimed at preventing and treating vision loss, and research in real-world settings examining prevention and treatment of substance use. These are the kinds of challenges that inspire our staff to do their best. It’s the dedicated employees committed to Emmes’ mission that make this a remarkable place to work.”</p>

10/27/2015

Company News

<p>The Emmes Corporation today announced that three of its statisticians, Dr. Ravinder Anand, Dr. Traci Clemons and Karen Martz, co-authored a pivotal study that examined lithium as a treatment for pediatric bipolar I disorder. The study was published in the October issue of Pediatrics.</p>

08/28/2015

Company News

<p>The Emmes Corporation today announced that one of its principal investigators and statisticians, Dr. Traci Clemons, co-authored a study that was just published by the Journal of the American Medical Association (JAMA). The researchers had conducted a five-year study with 4,000 patients to determine whether omega-3 and other nutritional supplements are associated with cognitive function. Dr. Clemons had led the Emmes team doing the clinical trials associated with the study.</p>