08/06/2020

Company News

<p>Emmes today announced that three corporate vice presidents have been promoted. Dr. Traci Clemons has been named chief research officer, Marian Ewell is now chief scientific innovation officer, and Jennifer Hester is the company’s chief human resources officer. These are all newly created positions for the company.</p>
<p>According to Dr. Anne Lindblad, president and chief executive officer, “Elevating these roles – research, scientific innovation, and human resources – is a tremendous step forward in our company’s evolution. It’s an endorsement for how far we’ve come as a major player supporting clinical trials and research for a wide range of human health issues. It reflects our growth and diversification across both government and commercial sectors. And finally, it’s a testament to the value of these three outstanding professionals, and the role they’ve played and will continue to play in our success.”</p>
<p>Dr. Traci Clemons, chief research officer, has served as the company’s executive vice president for research units and as principal investigator of the National Eye Institute’s Age-Related Eye Disease Study 2. She also provides leadership and statistical expertise for other contracts, including the Sickle Cell Disease Consortium for the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH), as well as several studies of ophthalmic diseases sponsored by the National Eye Institute and industry. </p>
<p>She joined Emmes in 1999 as a senior statistician and was later promoted to vice president and then senior vice president. She has led a number of important research studies for both government and commercial clients. In 2017, Dr. Clemons was named executive vice president. Earlier in her career, she was an assistant professor at the University of Mississippi Medical Center and a postdoctoral fellow at the Harvard School of Public Health.</p>
<p>Dr. Clemons said, “I look forward to helping evolve the structure of our therapeutic and research units. Elevating research to an officer-level position is a great responsibility and honor.”</p>
<p>She added, “This is important and fulfilling because of the diversity represented by these three promotions.”</p>
<p>Dr. Clemons has co-authored more than 100 papers that have been published in a number of scientific journals, including the Journal of the American Medical Association. She holds a Ph.D. and an M.S. in biostatistics from the University of Alabama at Birmingham, and a B.A. in mathematics from the University of West Florida.</p>
<p>Dr. Lindblad noted, “Traci combines excellent science and business acumen with an ability to align company functions with our mission and vision. Traci will set the company’s research and scientific priorities to align with the goals of the organization. She has extensive managerial research and industry experience.”</p>
<p>Dr. Marian Ewell, chief scientific innovation officer, helped to build Emmes’ biostatistics, bioinformatics, and clinical data standards services groups, which now include more than 90 staff members. She promotes new statistical methods with Emmes research projects, and her new role encompasses fostering a culture of innovation throughout the company. She also serves as principal investigator of the Statistical and Data Coordinating Center for the Clinical Research in Infectious Diseases contract with the NIH Division of Microbiology and Infectious Diseases.</p>
<p>After serving as a post-doctoral fellow and research assistant at the Harvard School of Public Health and the Dana Farber Cancer Institute, she joined Emmes in 1994 as a statistician and was subsequently promoted to senior investigator, vice president and then senior vice president. In 2017, Dr. Ewell was named executive vice president.</p>
<p>According to Dr. Ewell, “Emmes was founded by a statistician, whose vision has resulted in the company’s outstanding reputation for trusted clinical research. But we can’t rest on our laurels, and my priority will be to lead our new Statistical and Scientific Innovation team in extending our expertise and finding opportunities to partner with other organizations.”</p>
<p>In addition to co-authoring numerous scientific papers, Dr. Ewell reviews grant applications for several NIH agencies and served as the Advisory Board chair for the George Mason University Department of Statistics. She earned an Sc.D. degree in biostatistics from Harvard University’s School of Public Health, an M.S. in statistics from the University of Wisconsin, and a B.A. in statistics from Princeton University.</p>
<p>“Emmes maintains our competitive edge in the market through differentiation and continual innovation throughout the organization,” said Dr. Lindblad. “Having Marian in this role ensures we have a competent leader at the helm with a laser focus on keeping Emmes at the cutting edge of our statistical and scientific research.” </p>
<p>Jennifer Hester, chief human resources officer, has been vice president of human resources since 2017 and joined the company in 2006 as its director of human resources. She is responsible for the strategy and leadership of all the programs related to human<br />
resources management and related corporate service operations.</p>
<p>Before joining Emmes, Ms. Hester was manager of human resources at Spirent Communications and, before that, manager of finance and administration at North American Networks.</p>
<p>Ms. Hester commented, “Our human resources team remains focused on continuing to help grow Emmes’ competitive position in the market and ultimately to build our reputation as workplace of choice for prospective and current employees. We continue to grow our employee base at a double-digit rate, and my priority will be to recruit and retain a highly engaged team. I plan to continue to be active in the community and build strong, effective partnerships with local and state organizations supporting innovative, diverse, and active workforce development.”</p>
<p>Ms. Hester is on the board of directors for Montgomery County Workforce Development; serves as vice chair of the board of directors of Rockville Economic Development, Inc.; and participates on the executive committee for Leadership Montgomery. She is also on the board of Girls on the Run in Montgomery County, Maryland. She holds an executive MBA from the University of Maryland, an M.S. in personnel and human resources management from American University, and a B.A. in liberal arts & sciences from Virginia Polytechnic Institute and State University.</p>
<p>According to Dr. Lindblad, “As Emmes continues to grow, human resources, talent, benefits, training and facilities are crucial to our success. I have depended on Jennifer over the years to see the future so we do not fall behind supporting our most important asset – our employees. Under Jennifer’s leadership, we have been selected four times as a Washington Post top workplace in the greater DC area, and we’re also a five-time winner of the Alliance for Workplace Excellence Seal of Approval award. ”</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;

06/17/2020

Company News

<p>Emmes today announced that it was selected as one of the best places to work in the greater Washington area. The Washington Post’s 2020 <a href="https://www.washingtonpost.com/pr/2020/06/12/washington-post-announces-…; target="_blank">Top Workplaces</a> list ranked private, public, nonprofit and government agencies based on the highest engagement ratings from their employees.</p>
<p>The Washington Post partnered with employee research and consulting firm Energage, LLC, to conduct the survey, and the highest ranked workplaces were chosen based on employee responses about their own company. There were 3,500 area companies invited to participate, and 406 were surveyed. This is the seventh year the survey has been conducted.</p>
<p>The Top Area Workplace awards, which are based solely on employee survey feedback, honored<br />
200 organizations as Top Workplaces. Emmes was selected in the large company category, which ranges from 500 to 999 employees. The list, along with stories about how employees have coped during the pandemic, will be featured in a special Top Workplaces magazine on October 14. The rankings in each category – small, midsize, large and a new category, largest – will be shared at that time.</p>
<p>“This is the fourth time we’ve been included in this prestigious awards list,” said Dr. Anne Lindblad, president and chief executive officer of Emmes. The fact that the rankings are based on an independent survey of employee opinions about our company makes this even more meaningful.”</p>
<p>She added, “It’s a privilege to have so many employees committed to making Emmes a great place to work and to making it a daily commitment to reflect our mission, vision and values. The health crisis this year has made our work even more critical, and our team is playing an instrumental role in supporting the clinical trials that will help bring COVID-19 therapies and vaccines to market.”</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;

06/15/2020

Company News

<p>Emmes today announced that it provided the Phase 3 clinical trial support for a new investigational cell therapy that offers a promising treatment opportunity for patients who need an allogeneic bone marrow transplant. Emmes’ work for <a href="https://www.gamida-cell.com/&quot; target="_blank">Gamida Cell Ltd.</a> , an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, involved full scope clinical trial support for this study that was conducted at more than 50 centers in the United States, Latin America, Europe and Asia. Emmes also supported the early development Phase 1 and 2 trials that began in 2010.</p>
<p>The therapy in development, omidubicel, is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The intent-to-treat results of this <a href="https://investors.gamida-cell.com/news-events/press-releases/news-relea…; target="_blank">study</a> in 125 patients showed that omidubicel was generally well tolerated and that the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group of patients who received standard umbilical cord blood (p<0.001). </p>
<p>The chief medical officer for Gamida Cell, Dr. Ronit Simantov, stated, “We are very proud of this rigorous, well executed trial and we truly appreciate the support of everyone who partnered with us to help move the field forward. We truly value the work and expertise that Emmes provided, and the agility and commitment of the Emmes staff played a critical role in achieving this clinical development milestone.” </p>
<p>Dr. Anne Lindblad, president and chief executive officer at Emmes, added, “Gamida Cell’s positive topline data from the trial is very encouraging, and we are hopeful that it represents a life-saving treatment option for bone marrow transplant candidates. Our employees are proud to work on therapies like this that bring hope to people who are suffering, and I’m proud that we’ve partnered with Gamida on this effort for 10 years.”</p>
<p>The international, multi-center, randomized Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant. The study included patients aged 12-65 years with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, or lymphoma.</p>
<p>Omidubicel is an investigational therapy, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.</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;

05/26/2020

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;

05/18/2020

Company News

<p>Emmes reported revenues of $125 million in 2019 and has more than 750 employees globally. More than 675 employees work in Maryland, Virginia and Washington, D.C. </p>
<p>The company is expecting to hire nearly 70 new employees to support new and expanded clinical research projects. This represents an increase of approximately 10 percent of its area-wide workforce. The positions include clinical operations staff, biostatisticians, bioinformatics experts, project control analysts, project managers, data management staff, technical writers, clinical research auditors, and proposal manager. The company has offices in Rockville, MD, Frederick, MD and Tysons Corner, VA. Emmes continues to maintain a robust teleworking environment. </p>
<p>“We provide the backbone of support to both government and biopharmaceutical companies involved in developing treatments and vaccines associated with a wide range of diseases and disorders,” said Dr. Anne Lindblad, president and chief executive officer. “Our operational, data management, regulatory, safety, statistical and data analysis support for clinical trials and human health research is highly valued, and the result is continued growth. This means promoting employees, giving people more opportunities for job expansion and flexibility, and adding new staff.” </p>
<p>Dr. Lindblad noted that three new executives have joined the leadership team since November: a chief business officer, vice president of clinical operations, and chief medical officer. Two new business development directors were just hired. The company also promoted three employees to the position of vice president. </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;