05/26/2020

Company News

<p>Emmes today announced that its data and statistical analysis work for the Adaptive COVID-19 Treatment Trial (ACTT) played an important role in the accelerated timetable to evaluate remdesivir’s effectiveness in treating hospitalized COVID-19 patients. </p>
<p>The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored the clinical trial, which included 1,063 participants at 60 sites in 10 countries. Emmes has a long history in supporting NIAID’s <a href="https://www.niaid.nih.gov/about/dmid&quot; target="_blank">Division of Microbiology and Infectious Diseases</a> and has served as a Statistical and Data Coordinating Center for more than 350 of its clinical trials since 1998. </p>
<p>Two Emmes employees, Michelle Green and Dr. Mat Makowski, were co-authors on the <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2007764?query=featured_home…; target="_blank">Preliminary Report</a> about the clinical trial, “Remdesivir for the Treatment of COVID-19,” published in the May 22, 2020, New England Journal of Medicine. Green, a vice president, is Emmes’ lead project manager, and Makowski is the lead Emmes biostatistician on the trial. Jennifer Ferreira, senior biostatistician, and Dr. Michael Wierzbicki, biostatistician manager, were also recognized for their work.</p>
<p>Dr. Anne Lindblad, president and chief executive officer, said, “Our Emmes team was able to support the launch of this pivotal therapeutic trial during a pandemic in less than four days from receipt of the study protocol to the first patient enrolled. Our experience in supporting clinical trials for H1N1 influenza, SARS, Ebola and Zika, among others, has proven extremely valuable.”</p>
<p>The ACTT <a href="https://www.niaid.nih.gov/news-events/nih-clinical-trial-remdesivir-tre…; target="_blank">clinical trial</a> began in late February to evaluate the use of remdesivir, an investigational anti-viral treatment developed by Gilead Sciences, Inc. Preliminary <a href="https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesiv…; target="_blank">results</a> showed remdesivir to be superior to standard care in improving time to recovery in adults hospitalized with lung involvement and moderate-severe COVID-19. The median recovery time was 11 days for subjects who received remdesivir compared to 15 days in subjects receiving placebo. On May 1, the U.S. Food and Drug Administration announced an Emergency Use Authorization that allowed hospitals to use the drug to treat patients with severe cases.</p>
<p>Emmes’ Michelle Green, one of the authors of the New England Journal of Medicine preliminary report, said, “Our Emmes team has been working nearly around the clock to support this research. The response to the pandemic called for both unprecedented speed and stringent attention to detail, and we are all proud to play a part in this important study.”</p>
<p>Emmes continues to support the adaptive-design ACTT trial in its second stage, in which subjects will be treated with remdesivir and randomized to receive the anti-inflammatory drug baricitinib, developed by Eli Lilly and Company, or placebo. ACTT2 is expected to enroll more than 1,000 hospitalized adults at up to 100 U.S. and international sites.</p>
<p>The company is providing scientific and operational support for a number of other organizations conducting research associated with COVID-19 therapies and vaccines. One, for SaNOtize, is a clinical trial for Nitric Oxide releasing solutions to prevent and treat mild/moderate infection. Another is for the NIH Phase 1 <a href="https://www.niaid.nih.gov/news-events/nih-clinical-trial-investigationa…; target="_blank">clinical trial</a> for Moderna, Inc.’s mRNA-1273, an investigational vaccine.</p>
<p>About the Research<br />
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500002C.</p>
<p>About Emmes<br />
Emmes is a leading Contract Research Organization working with both public and private sector organizations. We collaborate with our clients to produce valued, trusted scientific research, and our team members are passionate about making a difference in the quality of human health. Emmes has 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;

05/04/2020

Company News

<p>Emmes today announced that Dr. Joe Sliman has been named the company’s chief medical officer (CMO). </p>
<p>According to Dr. Anne Lindblad, president and chief operating officer, “The depth and breadth of Joe’s biopharmaceutical and government experience will be extremely valuable in supporting both our government and commercial clients.”</p>
<p>Dr. Sliman has held senior roles at several biotech/pharmaceutical firms, and before that led U.S. Navy Pacific Fleet disease surveillance programs, which included influenza surveillance, preparedness and prevention. He has more than 16 years of experience in directing product development, clinical development and research in public health and in multiple medical therapeutic areas. These include infectious disease and vaccines, respiratory, neurology, neuroendocrinology, nutrition, circadian rhythm disorders, dermatology and gastroenterology. On the clinical side, he spent more than eight years directing clinical and public health operations at clinics, acute care centers, field sites and community health offices. </p>
<p>Dr. Sliman replaces Dr. Robert Lindblad, who has served as CMO for the last 20 years. Dr. Lindblad will continue as executive vice president, supporting various programs for Emmes’ clients, as well as strategic development, global business development, and evolving key partnerships. </p>
<p>“Joe will be an outstanding addition to the company’s leadership team,” said Dr. Robert Lindblad, “and he’ll continue to expand our medical affairs and pharmacovigilance departments. His work with Department of Defense, the Centers for Disease Control, and the Biomedical Advanced Research and Development Authority will be especially useful, as we continue to support these important agencies.” </p>
<p>Before joining Emmes, Dr. Sliman was senior director of clinical research and medical director at Social & Scientific Systems. Previously, he served as CMO at Synthetics Biologics, Inc. and held leadership roles at both Vanda Pharmaceuticals Inc. and Medimmune, LLC. His first position, after leaving the Navy’s Pacific Fleet, was at Dynport Vaccine Company.</p>
<p>“I look forward to supporting Emmes’ diverse clientele, especially as the company continues to expand its commercial base and grow its government work,” noted Dr. Sliman. “This is an especially important time, in light of the COVID-19 response,” he added. “My previous roles with development of respiratory vaccines in both commercial and government programs, most recently Vaccines Research Consortium studies for the National Institute of Allergies and Infectious Diseases, are relevant to Emmes’ vaccine clinical trials.”</p>
<p>Dr. Sliman received his M.D. from the Uniformed Services University of the Health Sciences, a Master of Public Health degree from Johns Hopkins University, and a B.S. in molecular and cell biology from Pennsylvania State University. He completed his internship at the National Naval Medical Center and his residency in Preventative Medicine at the Johns Hopkins Bloomberg School of Public Health. Dr. Sliman is Board Certified in Public Health and General Preventive Medicine, and he is also certified in Clinical Tropical Medicine and Travelers’ Health by the American Society of Tropical Medicine and Hygiene. </p>
<p>A native of western Pennsylvania, Dr. Sliman lives in Kensington, Maryland, with his family. He has been active in the community, including serving on the boards of the Rotary Club of Southern Frederick County, the Mental Health Association of Frederick County, and the Trinity School of Frederick.</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;

04/06/2020

Company News

<p>Emmes today announced that Heather Hill, Dr. Adam Mendizabal and Dr. Nilay Shah have been promoted to vice president. According to Dr. Anne Lindblad, president and chief executive officer, “These promotions reflect their talent and value to the organization. Heather, Adam and Nilay demonstrate our commitment to developing staff and promoting from within. They will strengthen and add great value to our leadership team and will support our plans to grow both internally and externally.” </p>
<p>Heather Hill leads the company’s Vaccine and Infectious Disease research group. With more than 25 years of clinical research experience, Hill has led a number of government, commercial and non-profit infectious disease projects for the company. She is now the co-principal investigator for the Clinical Research in Infectious Diseases (CRID) project sponsored by NIH’s National Institute of Allergy and Infectious Diseases. Here, Emmes is responsible for the statistical and data coordination of more than 100 vaccine and infectious disease protocols. Hill joined Emmes in 2002 as a project director, following five years of active duty in the U.S. Army and a four-year stint as a laboratory manager for an Army contractor. Since then, she has participated in or led the implementation of a range of clinical trials for biodefense agents and pandemic preparedness, including vaccines against influenza, smallpox and anthrax. </p>
<p>Hill noted, “It’s an honor to contribute to the fight against infectious diseases, particularly the emerging threats that require us to have clinical trials up and running in days.”</p>
<p>During her tenure at Emmes, Hill has co-authored more than 50 papers that have been published in a number of scientific journals. She holds an M.S. in environmental biology from Hood College, and a B.S. in biological sciences from Colorado State University.</p>
<p>Dr. Lindblad, said, “Our leadership, employees and clients from both NIH and industry turn to Heather when leadership is needed to respond to pandemics including H1N1, Avian flu, Ebola and now Covid-19. Her teams are consistently recognized for both speed and quality of execution.”</p>
<p>Dr. Adam Mendizabal co-leads Emmes’ Transplant, Allergy and Autoimmune research group. During his 17-year tenure, Adam has held positions of increasing responsibility focusing on clinical trials in stem cell transplantation and cellular therapy for both biotechnology and government clients. A highlight of Adam’s career has been to serve as the co-principal investigator of the Data and Coordinating Center of the Blood and Marrow Transplant Clinical Trials Network, which supports research on behalf of the National Institutes of Health, the National Heart, Lung and Blood Institute, and the National Cancer Institute. </p>
<p>According to Dr. Mendizabal, “Emmes has given me a great opportunity to expand the body of knowledge about transplant and cellular therapies, and the results of our clinical trials are having a profound impact on the way patients are being treated.”</p>
<p>He has collaborated on more than 50 scientific publications on topics ranging from blood and marrow transplantation to childhood leukemia. Mendizabal earned a Ph.D. in epidemiology from The George Washington University; M.S. in statistics from Rutgers University; and B.A. biology from Rutgers College.</p>
<p>Dr. Lindblad said, “Dr. Mendizabal and his team are regarded as respected experts by their partners in transplant and cellular therapy research. His contributions to scientific publications have produced numerous high-impact, practice-changing results. ”</p>
<p>Dr. Nilay Shah is vice president of strategic partnerships and medical officer. He started his career practicing medicine overseas and then worked as a clinical researcher at the University of Pennsylvania. Dr. Shah started at Emmes in 2005 as a safety/medical monitor before assuming leadership roles in ophthalmology, autoimmune and inflammation projects. He has more than 15 years of experience in leading various commercial studies, many of which have received regulatory approval. More recently, he led a privately funded device study using Artificial Intelligence (AI), which resulted in its being the first and only FDA-cleared diagnostic AI system to detect diabetic retinopathy in the ophthalmic space. Dr. Shah also has been actively involved in business development.</p>
<p>According to Dr. Shah, “Our long and productive partnerships with our clients – and the scientific value we bring – are part of our legacy. I’m excited to expand this into building new relationships with business partners, both domestically and internationally, that offer skill sets and values that complement ours.”</p>
<p>Dr. Shah has written numerous ophthalmic-related papers in a wide range of scientific journals, and he is a grant reviewer at The Maryland Technology Development Corporation, known as TEDCO, for the Maryland Innovation Initiative. He attended Rutgers University before obtaining his MBBS degree in medicine and surgery from the Somaiya Medical College and Research Center at the University of Mumbai in India (MD equivalent in the U.S.)</p>
<p>“Dr. Shah is a passionate advocate for finding truth in research, reflecting our vision of being the trusted partner to researchers seeking to improve human health,” said Dr. Lindblad. “He is an innovative thinker and problem solver, and he uses those skills to understand client needs and deliver solutions.”</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;

03/23/2020

Company News

<p>Emmes today announced that Kathleen Wolf has joined the company as vice president of clinical operations. She has two decades of leadership experience in the biopharmaceutical industry, including most recently as a senior director with AstraZeneca’s MedImmune unit. </p>
<p>Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “Kathleen is an outstanding addition to our leadership team. Her background in both biotech and pharmaceutical settings will be a great asset. Her experience in building collaborative, cross-functional teams complements our clinical operations platform.</p>
<p>“It’s an exciting time for Emmes as we expand our role in addressing the world’s most pressing human health problems,” she continued.</p>
<p>Wolf began her career as a clinical research coordinator focused on Alzheimer’s and Parkinson’s research. Over the next decade, she assumed management roles with increasing responsibility at a research center and two pharmaceutical companies: Shire and Human Genome Sciences. Wolf joined AstraZeneca Pharmaceuticals in 2006 where she led portfolio development plans and resource strategies across infectious disease, oncology and respiratory therapeutic groups. In 2009, she moved to AstraZeneca’s MedImmune unit, where she began as therapeutic director for infectious disease and vaccines and then moved into the role of senior director and clinical operations head.</p>
<p>Wolf said, “Emmes puts a premium on collaboration and has built an outstanding reputation for clinical research across a range of therapeutic areas and services. Blending creativity with greater standardization will give us an even stronger foundation to expand our presence with a larger number of partners.”</p>
<p>She added, “I’d like to build upon that, with a fundamental goal of keeping the patient at the heart of how we address human health in clinical research.”</p>
<p>Wolf holds a Master of Business Administration from Georgetown University and a Bachelor of Arts in international affairs from George Washington University. She is a guest lecturer for the Master of Science in Biotech Program at Georgetown University, as well as a panelist and judge for student entrepreneurship competitions at Georgetown Business/Medical Schools. She and her family live in Cabin John, Maryland.</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;

01/21/2020

Company News

<p>Emmes today announced that the Food and Drug Administration (FDA) has extended the labeling of ampicillin, a commonly used antibiotic, to include use in infants younger than 28 days in the treatment of serious conditions meningitis and septicemia. FDA’s approval was based in part on a National Institute of Child Health and Human Development (NICHD)-funded <a href="https://dash.nichd.nih.gov/study/20222&quot; target="_blank">study</a>, conducted under the <a href="https://www.nichd.nih.gov/research/supported/bpca/accomplishments&quot; target="_blank">Best Pharmaceuticals for Children Act (BPCA)</a>.</p>
<p>Emmes provided full-service data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses for the ampicillin study, and facilitated the study protocol design. Emmes is in the third year of a 10-1/2 year contract supporting pediatric clinical trials aimed at improving the labeling of drugs for pediatric use.</p>
<p>According to Dr. Perdita Taylor-Zapata, BPCA program lead at NICHD, “Children are considered therapeutic orphans due to the lack of dosing, safety and efficacy information for drugs used routinely in this population. Ampicillin is one of the newest drug labeling changes resulting from study data submitted to and approved by the FDA, and it represents another step forward in helping doctors safely prescribe medication to their youngest patients.”</p>
<p>Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “Emmes’ study design, data management, statistical analysis and other services provide a platform to ultimately ensure that drugs and therapies for children are safe, effective and used in the proper doses.”<br />
 <br />
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;

01/06/2020

Company News

<p>Emmes today announced that the U.S. Food and Drug Administration (FDA) has approved a prescription-only medical device used to estimate the weight of infants who are up to 90 days of age.</p>
<p>The Mercy babyTAPE is a tape-measure-like device that permits health care professionals to estimate the body weight of preterm and full-term infants when a scale may not be available or practical to use. Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments. This easy-to-produce device could be especially useful in emergency or resource-constrained situations such as remote or rural areas, and in developing countries. </p>
<p>The Mercy babyTAPE was developed under the <a href="https://www.nichd.nih.gov/research/supported/bpca&quot; target="_blank">Best Pharmaceuticals for Children Act</a>, which mandates the National Institutes of Health (NIH) to prioritize therapeutic areas in critical need of pediatric-specific treatment information, sponsor pediatric clinical trials, and submit the data for review by the U.S. Food and Drug Administration (FDA) for action on affected products.</p>
<p>Emmes coordinated operations and analyzed the data from the NIH-funded studies for the original Mercy TAPE devices, which are used in children ages 2-16 years. These were the first weight estimation devices developed under the BPCA program and the first weight estimation devices to be cleared by the FDA. The Mercy babyTAPE now brings the same weight estimation process to infants.</p>
<p>All were developed by Dr. Susan M. Abdel-Rahman at The Children's Mercy Hospital of Kansas City, Missouri. According to Dr. Abdel-Rahman, “We now have a suite of low-cost, easy-to-use tools that take the guesswork out of estimating weight, one of the most important vital signs in a child. Combined, the Mercy TAPE and babyTAPE permit weight estimation from birth through adolescence in settings where this information is critical for delivering the best medical care possible.” </p>
<p>Dr. Anne Lindblad, president and chief executive officer of Emmes, added, “The development of the TAPE devices is a wonderful example of collaboration between government agencies, researchers and industry. It’s an honor for Emmes to partner with an outstanding researcher like Dr. Abdel-Rahman.”</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;

12/02/2019

Company News

<p>Emmes today announced that it is part of a team of medical centers, universities and private industry supporting the development of a “universal influenza vaccine” that could provide longer-lasting protection than current vaccines and combat a wider variety of influenza viruses.</p>
<p>This is part of the newly launched Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, under the direction of the National Institute of Allergy and Infectious Diseases (NIAID). According to NIAID, which is part of the National Institutes of Health, the network of research centers will work together in a coordinated, multidisciplinary effort to develop more durable, broadly protective and longer-lasting influenza vaccines.</p>
<p>Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “This project builds upon our experience in supporting clinical trials of influenza vaccines and other emerging infectious diseases, such as Zika and Ebola. It’s exciting to be on the ground floor of this innovative program for NIAID.”</p>
<p>Emmes is working with two other companies to provide the data management and statistical support for the CIVICs program. Digital Infuzion is the prime contractor, with Emmes and Gryphon Scientific, LLC, as subcontractors. All three companies are headquartered in Maryland. </p>
<p>According to the Centers for Disease Control and Prevention, influenza causes hundreds of thousands of hospitalizations and tens of thousands of deaths every year. The time it can take to develop vaccines, plus the fact that existing vaccines do not always protect against the continually changing strains of influenza, led to the new NIAID program.</p>
<p>The Digital Infuzion, Gryphon Scientific and Emmes team members are responsible for<br />
designing statistically sound preclinical experiments and clinical trials. Other focuses include performing data analyses, making results available across the CIVICs program, and ensuring that data is available in publicly accessible databases.</p>
<p>Dr. Stephan Bour, chief scientific officer for Digital Infuzion, said, “Emmes is a great addition to our team. The company has more than 30 years of experience with NIAID and has built an outstanding reputation in statistical and data management. We look forward to building our partnership and making a strong contribution to this important strategic endeavor.”</p>
<p>Dr. Lindblad added, “Emmes has been expanding our presence in the Maryland biotech community, and it’s a pleasure to collaborate with Digital Infuzion. The company is known for using technology and bioinformatics to develop novel solutions for the health care industry.”</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;
<p>This project has been funded in whole or in part with Federal funds from the National Institute of Allergy & Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93019C00078.</p>

10/10/2019

Company News

<p>Emmes today announced the award of eight new task order contract awards associated with the Helping to End Addiction Long-termSM Initiative, known as the NIH HEAL InitiativeSM. The total value for the eight contracts is more than $9 million. The contract awards’ duration ranges from one to five years.</p>
<p>The National Institutes of Health launched the HEAL Initiative in April 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. The eight Emmes contract awards are among 375 grants, contracts, and cooperative agreements across 41 states made by the National Institutes of Health in fiscal year 2019 to apply scientific solutions to reverse the national opioid crisis. </p>
<p>“The new contracts recognize our 10-year track record for providing data and statistics support to the research sponsored by NIH’s National Institute for Drug Abuse (NIDA),” said Dr. Paul Van Veldhuisen, Emmes’ chief operating officer. “It’s extremely satisfying for our company and our staff to join with leading researchers across the country in combatting the opioid epidemic.”</p>
<p>As the data and statistical center for the NIDA-sponsored National Drug Abuse Treatment Clinical Trials Network, or CTN, Emmes will play a critical role supporting the enhancement of the CTN to address opioid research. This enhancement will include activities to improve access to high-quality addiction treatment, including studies of the delivery of Opioid Use Disorder (ODU) in general medical settings, as well as ways to prevent the progression of moderate to severe ODU.</p>
<p>Emmes will be responsible for establishing systems for data collection and management; designing and performing statistical analyses; reviewing and monitoring the quality of data and clinical trial progress; preparing study reports; and supporting manuscripts for publication.</p>
<p>Dr. Anne Lindblad, Emmes’ president and chief executive officer, noted, “This new work truly reflects our mission to bring statistical solutions and dedicated research to the most pressing human health problems of our time.”</p>
<p>The company plans to hire about 10 additional staff members with statistical, data management and IT skills to work on the new contracts.</p>
<p>According to the NIH, the initiative is leveraging expertise from almost every NIH institute and center to approach the crisis from all angles and disciplines, and across the full spectrum of research.</p>
<p>"It's clear that a multi-pronged scientific approach is needed to reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addiction to opioids," said NIH Director Francis S. Collins, M.D., Ph.D., who launched the initiative in early 2018. "This unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to reversing this devastating crisis."</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;

09/30/2019

Company News

<p>Emmes today announced that it was ranked as one of the 100 largest private companies in the Washington metropolitan area. The ranking is compiled annually by the Washington Business Journal.</p>
<p>The company was ranked as the 83rd largest private company this year. Its most recently reported revenues were more than $114 million, and about 600 of the company’s 725 employees work in the Washington area.</p>
<p>Earlier this year, Emmes received a Workplace Excellence Seal of Approval award from Alliance for Workplace Excellence. The award recognized organizations committed to<br />
building excellent places to work, considering attributes like innovative corporate culture and management practices, family-friendly policies and programs, employee growth and learning opportunities, and a commitment to corporate responsibility. </p>
<p>Emmes also had been honored with a Gold Award from the Maryland Department of Health, which salutes businesses in the state that are committed to improving employee health and well-being. </p>
<p>“We are continuing to grow and invest in our people,” noted Dr. Anne Lindblad, president and chief executive officer of Emmes. “It’s an honor to be recognized as a leading private company and to receive recognition for our culture and values.</p>
<p>“We will continue to be creative and proactive in building an environment that enhances the development and opportunities for our team,” she added. “That way, they can focus on what they love to do: to collaborate with leading researchers in developing clinical trials and producing research that addresses the health needs of people representing all ages and walks of life.”</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;

04/02/2019

Company News

<p>Emmes today announced that it provided the data management support for a <a href="https://www.nih.gov/news-events/news-releases/acyclovir-labeling-now-in…;, funded by the National Institutes of Health (NIH) and approved by the Food and Drug Administration (FDA), to safely use Acyclovir to treat infants infected with the Herpes Simplex Virus. Acyclovir, known by the brand name Zovirax, now includes recommended usage and dosage for newborns and infants up to three months of age on its label.</p>
<p>The Best Pharmaceuticals for Children Act (BPCA) mandates that NIH prioritize therapeutic areas in critical need for pediatric labeling, sponsor pediatric clinical trials, and submit the data to the FDA for consideration for labeling changes. The clinical trials are sponsored by the National Institute of Child Health and Human Development (NICHD), with the labeling reviews and approvals administered by the FDA.</p>
<p>In the NIH news release, Dr. Perdita Taylor-Zapata, BPCA program lead at NICHD, stated: “With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients.”</p>
<p>Newborns can become infected with the virus during pregnancy, labor and delivery, or shortly after birth if the mother develops genital herpes near the end of her pregnancy. The Herpes Simplex Virus in newborns can cause death or long-term problems such as blindness and damage to the brain and other organs.</p>
<p>Emmes has served as a data coordinating center for the BPCA <a href="https://secure.emmes.com/emmesweb/news?page=1">contract</a&gt; since August 2009. This entails study design, data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses. </p>
<p>Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “This is one of our largest contracts and one that our Emmes team is extremely proud to support. Our role as a data coordinating center is a critical step in the process to study drugs and therapies used for infants and children and determine whether drug labeling updates are needed.”</p>
<p>The Best Pharmaceuticals for Children Act was enacted in 2002 and subsequently reauthorized by the U.S. Congress in 2007, 2012 and 2017. 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>Acyclovir is the first BPCA drug labeling change in 2019, and others are likely to follow. </p>
<p>Lindblad added, “Nine other drugs associated with this BPCA project are in various stages of review at the FDA. Ultimately, what this means is that more infants, young children and teenagers will benefit from careful labeling and appropriate treatment options for a variety of diseases.”</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;