12/14/2020

Company News

<p>Emmes today announced that it has conducted the data and statistical analysis for the second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2). The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.</p>
<p>Baricitinib, produced by Eli Lilly and Company, has been used to treat adults with moderate to severe rheumatoid arthritis. Baricitinib, in combination with remdesivir for COVID-19 patients, received Emergency Use Authorization on November 19.</p>
<p>The ACTT-2 study, which was conducted from May to July 2020, was a randomized, double-blind, placebo-controlled trial that enrolled more than 1,000 participants at more than 60 U.S. and international sites. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored the trial.</p>
<p>The trial found that baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating clinical status improvement. This was especially notable among patients requiring high-flow oxygen or non-invasive mechanical ventilation. The combination therapy reduced recovery time in these patients from 18 days to 10 days and was associated with fewer adverse events compared to remdesivir alone. </p>
<p>Three Emmes employees were among the co-authors on the <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2031994?query=RP&quot; target="_blank">report</a> about the ACTT-2 trial, “Baricitinib plus Remdesivir for the Treatment of Hospitalized Adults with COVID-19),” published in New England Journal of Medicine on December 11, 2020. They are Michelle Green, a vice president and Emmes’ lead project manager for the trial; Dr. Mat Makowski, lead Emmes biostatistician; and Jennifer Ferreira, senior biostatistician.</p>
<p>Additional Emmes team members who contributed to the report included Dr. Thomas Conrad, Jill El-Khorazaty, Dr. Michael Wierzbicki, and Heather Hill. </p>
<p>“This is the fourth time this year that Emmes employees have co-authored articles in the New England Journal of Medicine on COVID-19,” said Dr. Christine Dingivan, president and chief executive officer of Emmes. “We are honored to have many members of our team as active contributors in finding ways to treat and prevent COVID-19.” </p>
<p>Michelle Green, one of the Emmes authors of the New England Journal of Medicine report, added, “Once again, the Emmes ACTT team has executed high-quality activities at an accelerated pace to meet trial timelines.”</p>
<p>The first iteration of the study, ACTT-1, evaluated remdesivir’s effectiveness alone in treating patients hospitalized with COVID-19. Developed by Gilead Sciences, Inc., remdesivir is an antiviral medication that was approved by the Food and Drug Administration (FDA) for emergency use on May 1. The ACTT-1 preliminary report was published in the New England Journal of Medicine on May 22, with the <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2007764&quot; target="_blank">Final Report</a> issued on October 8. The ACTT-1 trial was one of the studies used in support of the <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fdas-approval-ve…; target="_blank">FDA approval</a> of remdesivir on October 22.</p>
<p>Emmes has served as a Statistical and Data Coordinating Center for more than 350 trials supporting NIAID’s Division of Microbiology and Infectious Diseases since 1998. This includes recent support of the Phase 1 clinical trial for mRNA-1273, the investigational COVID-19 vaccine developed by Moderna, Inc. and NIAID. The company is also providing scientific and operational support for other organizations conducting research associated with COVID-19 therapies and vaccines. </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;

11/02/2020

Company News

<p>Emmes today announced that it provided the data and statistical analysis support for a Phase 1 clinical trial of an investigational COVID-19 vaccine, mRNA-1273, that enrolled adult volunteers. The results of this clinical trial were published in the New England Journal of Medicine (NEJM) on September 29. </p>
<p>Three Emmes employees were among the co-authors of the recent <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2028436&quot; target="_blank">report</a>, “Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.” The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician. </p>
<p>In its role as the statistical and data collection and coordination center, Emmes managed development of the statistical analysis plan and performed all data analysis. </p>
<p>The recent NEJM publication focused on the immune response to the vaccine and whether the vaccine produced any adverse effects in two groups of older adults (56 to 70 years or ≥ 71 years). An earlier report in NEJM described findings from a Phase 1 trial of the mRNA-1273 candidate vaccine in adults ages 18 to 55 years old.</p>
<p>According to Albert, “It’s an honor to contribute to a study targeted on finding a vaccine for COVID-19 and to participate in writing two articles published in the prestigious New England Journal of Medicine during the same year.” </p>
<p>He added, “The whole world is watching the results of this and other vaccine trials, as we move closer to finding safe, effective ways to address this devastating disease.”</p>
<p>The first part of the Phase 1 trial, which began in March, tested 45 adults, while the subsequent portion enrolled 40 older adults during April and May. As described in the Preliminary Report published in NEJM in July, this was a dose-escalation, open-label trial to assess the safety of the mRNA-1273 vaccine and its ability to induce an immune response. Both papers concluded that adverse effects were predominantly mild or moderate in severity. The side effects, such as fatigue, chills and headache, were found to be dose-dependent and were more common after the second immunization. According to this Sept. 29 report, volunteers receiving the 100 mcg dose produced a stronger antibody response than the 25 mcg dose. This observation supported the use of the 100 mcg dose vaccine in a Phase 3 trial of the candidate.</p>
<p>The trial was conducted at Kaiser Permanente Washington Health Research Institute in Seattle, the Emory University School of Medicine in Atlanta and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center in Bethesda, Maryland. The vaccine was co-developed by researchers at the <a href="https://www.niaid.nih.gov/about/vrc&quot; target="_blank">Vaccine Research Center</a>, <a href="https://www.niaid.nih.gov/&quot; target="_blank">NIAID</a> and at <a href="https://www.modernatx.com/&quot; target="_blank">Moderna, Inc.</a>. Moderna, Inc. manufactured and provided the vaccine candidate. </p>
<p> “COVID-19 is the latest in a long history of infectious disease research that Emmes has supported,” noted Dr. Christine Dingivan, Emmes president and chief executive officer. “This includes H1N1 influenza, SARS, Ebola and Zika. Our team has spent many long hours – nights and weekends – collecting and evaluating the statistical data, and we’ll continue to do everything we can to combat this global public health emergency.”</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;

11/02/2020

Company News

<p>By Sara Gilgore – Staff Reporter, Washington Business Journal<br />
Oct 22, 2020, 5:00am EDT</p>
<p>Grow the biopharmaceutical business. Break into new geographies. Hire up.</p>
<p>Those are among Emmes President and CEO Dr. Christine Dingivan’s priorities less than a month into the job at the helm of the Rockville company, which conducts clinical research and trials for public and private sector customers, including for Covid-19 treatment candidates of late. Dingivan — a private equity and biopharmaceutical industry veteran and, now, first-time chief — succeeds Anne Lindblad, who retired at the end of September after nearly four decades with the company. </p>
<p>“We had a terrific alignment of mission,” Dingivan, who started in late September, said in an interview. “I felt that Emmes shared my passion around public health — diseases that are particularly challenging in this world, and Covid is one of them.” </p>
<p>Dingivan most recently served as head of global drug development for Switzerland pharmaceutical giant Novartis International AG (NYSE: AVS). Before that, she was chief medical officer and global head of strategic client solutions for North Carolina research company PPD Inc. (NASDAQ: PPD), and spent 12 years at MedImmune, now part of British biopharma AstraZeneca PLC (NASDAQ: AZN). She received her medical degree from Dartmouth Medical School and holds a bachelor’s in bioengineering from the University of Pennsylvania.</p>
<p>She joins the company during an aggressive hiring spree that has added more than 150 employees, bringing its total count to nearly 800 full time. She plans to keep that up through December, filling openings for both clinical research positions and business roles “so that we position ourselves for scalable growth in the future and we do that a bit more efficiently than we do it now,” she said. Emmes, which logged $125 million in revenue last year, will also build out its statistics and data analytics capabilities, she said.</p>
<p>After spending her first few weeks on the job identifying her focus areas and getting to know her team — remotely, at least — she spoke with the Washington Business Journal about how the global health crisis has affected the business and what’s next for the industry. We’ve edited this interview for length and clarity.</p>
<p><strong>What are your initial top priorities in this role? </strong>I’d love to see the expertise of Emmes be shared with the broader biopharma industry, because right now, the biggest part of our business is with the U.S. government. I see this passion and mission around public health to be expanded beyond where we are now, as we grow that biopharma business and that client base.</p>
<p><strong>What else?</strong> I would love to see Emmes grow its footprint a bit more geographically. I think there’s an excellent footprint between North America, the U.S. and Canada, as well as an office in India. But I think there’s room for us to expand into the U.K., EU, other areas that do exceptional work in clinical research and in public health.</p>
<p><strong>What’s driving the company’s growth?</strong> I think it definitely is partly due to the pandemic research. Since we were already a very established partner with the [National Institute of Allergy and Infectious Diseases], I think people — the community of researchers and companies that had drugs to potentially treat Covid-19 or even vaccines, to prevent it — knew that we had expertise.<br />
What other dynamics have changed during the pandemic? Typical biopharma clients wanting to leverage that expertise, because no one really had experience with Covid-19. So there was also expansion, not just of more government work for us but also more of the nonpublic sector. The typical biopharma was reaching out and saying, “Can you help us develop this drug, this therapeutic, for Covid-19?”</p>
<p><strong>What do you see as your biggest challenge in the current landscape?</strong> We’ve had to reengineer process, and we’ve had to immediately get IT equipment to associates. We did not have a huge remote workforce before the pandemic. Logistics would jump out to me as No. 1.</p>
<p><strong>What has been the immediate impact to the industry?</strong> Our industry in general has had some delays because of the pandemic — not being able to go to research sites to do the work of collecting the data and checking on the quality of the work down at the sites. We had to learn how to use remote tools there in order to get the job done. Being able to still ensure the conduct of clinical trials during a pandemic requires a lot of different adjustment.</p>
<p><strong>What has changed long term?</strong> We’ve seen greater embracing by the regulatory authorities, of new ways of doing the same things — leveraging digital technology and things that may have taken a slower curve to get them adopted. Our industry overall has advanced in that way, as a result. So we’ve had to really speed up the deployment of some of those new tools. </p>
<p><strong>What are some examples?</strong> The adoption of telemedicine as a part of a clinical trial experience, not just a part of our own personal medical care. Now we’re starting to be able to use that in the clinical trial process as a replacement for a face-to-face visit, which in the past was not acceptable, but now we’re seeing increased acceptance of that. Another is using wearable technology, just general digital devices to do things like routine vital signs monitoring.</p>
<p><strong>Do you think the industry will function differently going forward?</strong> I do. I wish we didn’t need a pandemic in order to make these advances. But I think it has moved us forward in a way that needed to happen.</p>
<p><strong>What happens next?</strong> I don’t think we’re ever going to go back to the way we were. I think these things will become permanent in how we do our work. I think we will increasingly do the work of clinical research in a remote environment. And I think that’s good, because we could democratize the field a bit; more people will be able to participate in it, and that’s good for health care in general, because there will be new treatments — I hope — as a result of a broader net being cast.</p>

10/30/2020

Company News

<p>Emmes today announced that the Montgomery County Chamber of Commerce has selected Emmes as the recipient of its 2020 Corporate Achievement Award. Dr. Anne Lindblad, who recently retired as the company’s president and chief executive officer, accepted the award at a virtual event hosted by the chamber on October 29.</p>
<p>According to Lowell Yoder, chairman of the Montgomery County Chamber of Commerce and M&T Bank’s group vice president for the Greater Washington Market, “Over the years, Emmes has set high standards for financial performance, sound management, and sustained growth – while contributing significantly to our community along the way.” </p>
<p>“I am proud that we have the opportunity to honor Emmes as our 2020 Corporate Achievement Award Winner,” said Gigi Godwin, president and CEO of the Montgomery County Chamber of Commerce. “We are so fortunate to have a successful company and global leader in biotechnology like Emmes right here in Montgomery County. Emmes is at the forefront of scientific discovery and innovation, working with the nation’s infectious disease experts, including NIH, to find solutions during this global pandemic.”</p>
<p>In accepting the award, Dr. Anne Lindblad said, “We’re especially honored because the recognition extends to our employees, whose ideas and active voluntarism are making a difference in the lives of others. Our new CEO, Dr. Christine Dingivan, is starting a new chapter of contributions that will continue to improve innovation in public health, while encouraging community activism.” </p>
<p>Other awardees included Dr. Francis Collins, director of The National Institutes of Health, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who accepted the Visionary of the Year award. Jose Andres of World Central Kitchen received the Corporate Social Responsibility Award.</p>
<p><strong>Dr. Lindblad’s speech during the Montgomery County Chamber of Commerce business awards event:</strong></p>
<p>Thank you to the Montgomery County Chamber of Commerce for this recognition, and to M&T Bank for sponsoring this award and supporting our mission.</p>
<p>Emmes opened our headquarters in Montgomery County back in the 70s and we’ve remained here ever since. Our founder recognized the vibrancy of this area with its proximity to NIH, FDA and numerous universities. We are honored to accept the Corporate Achievement Award from our home community.</p>
<p>When I started at Emmes back in 1982, we had just 15 employees. Since then, the county has become recognized as an epicenter for innovation and biotechnology. Being here is one reason we’ve been able to attract great employees – numbering over 800 now.</p>
<p>2020 has been a hard year. There are times when we’ve felt helpless. But being a part of finding solutions is restoring our hope. And the Emmes team has risen to the occasion. Leading clinical trials remotely required heroic efforts and very long days. I’ve always been proud of our staff’s credentials, but their will and determination during this time have been nothing short of extraordinary. </p>
<p>I wish all our employees could join me in person to give thanks for this recognition. Thank you on behalf of each and every one of them. </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;

10/15/2020

Company News

<p>Emmes today announced that it was selected as one of the best places to work in the greater Washington area. <em>The Washington Post’s</em> 2020 <a href="https://www.washingtonpost.com/graphics/2020/business/top-workplaces/&q…; target="_blank">Top Workplaces</a> list ranked private, public, nonprofit and government agencies based on the highest engagement ratings from their employees. The Washington Post partnered with employee research and consulting firm Energage, and the process is based on a scientific survey of employees who rate their workplace culture.</p>
<p>The Post’s annual survey honored 200 organizations as Top Workplaces. Emmes was selected in the large company category, which included organizations with between 500 and 999 employees. More than 3,600 area companies were invited to have their employees take the survey. </p>
<p>“We’re so pleased to be selected as a top area workplace for a fourth time,” said Dr. Christine Dingivan, president and chief executive officer of Emmes. “The fact that the selections are based entirely on independent employee survey feedback makes it even more of an honor.”</p>
<p>The Post’s 24-question employee engagement survey focused on a range of workplace culture attributes, such as coaching, encouraging employee development, feeling appreciated, and having confidence in company leadership.</p>
<p>“Our employees are passionate about making a difference in public health throughout the world,” added Dr. Dingivan. “This dedication has helped us add new customers and new employees this year. This growth, combined with prestigious recognition like The Post’s Top Workplaces selection, makes us even more attractive to job candidates, and we’re continuing to hire people whose dedication, credentials and values reflect our client needs and culture.”</p>
<p>Emmes received other recognition this summer, when it was honored by the Alliance for Workplace Excellence (AWE) for its commitment to balanced leadership and the overall success of its workforce. The company received its sixth consecutive Workplace Excellence Seal of Approval. The comprehensive assessment by the AWE considered seven key categories: family and employee friendly policies and programs; strong health and wellness initiatives; employee growth and learning opportunities; commitment to corporate, social and civic responsibility; diversity and inclusion practices; flexible work environment; and safety and security.</p>
<p>In other news, Emmes 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. The company was the 88th largest private company this year based on 2019 revenues of more than $125 million. Emmes has more than 700 employees working in the greater Washington area. </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;

09/23/2020

Company News

<p>Emmes today announced that Dr. Christine Dingivan has joined the company as its new president and chief executive officer. She is succeeding Dr. Anne Lindblad, who is retiring after 38 years at the company. Dr. Dingivan will be Emmes’ fourth chief executive since the company was founded in 1977.</p>
<p>According to Dr. Lindblad, “Finding the right fit for Emmes was critically important during our extensive CEO search. Christine has all the attributes we were looking for, and I am excited to turn over the reins. Although I’ll remain through the end of this year to help with the transition, she is officially our leader.”</p>
<p>Dr. Dingivan was previously a senior executive with Novartis. She began as the global head of portfolio strategy and innovation for Novartis Global Drug Development in Basel, Switzerland, where she was responsible for prioritizing the industry’s largest drug development pipeline, and later was named the first global head of data and digital. In this role, she designed and implemented a digital development strategy, leveraging innovative digital tools and advanced analytics, to transform the company’s drug development process. In addition, Dr. Dingivan created a digital innovation lab connecting entrepreneurs with Novartis mentors, partners and datasets in order to stimulate healthcare innovation. </p>
<p>Before joining Novartis in 2016, she spent eight years at PPD, Inc., a leading global clinical research organization. She served as chief medical officer and global head of strategic client solutions, and was a member of the executive committee. In this role, she led the growth and innovation strategy to enhance the company’s commercial business. Earlier, as global head of partnership strategies, she built a successful sales organization focused on the top 30 biopharmaceutical companies.</p>
<p>Following her medical training in surgery, Dr. Dingivan began her industry career at MedImmune, a biotechnology firm later acquired by AstraZeneca. She held various positions of increasing responsibility, ultimately rising to senior vice president, clinical research and operations. In this position, she led clinical research efforts across a wide range of therapeutic areas and was directly involved in the development and launch of a number of successful products, including the influenza vaccine FluMist®.</p>
<p>According to Dr. Lindblad, “Christine’s 20+ years spanning the biotech and pharmaceutical clinical research industries, her reputation as an industry leader, and her experience with a global CRO are assets to Emmes as we expand our global capabilities. She combines science, medical research and business acumen with excellent strategic and communication skills.”</p>
<p>Dr. Lindblad continued, “Our company was built on a culture of collaboration and science, and we have been fortunate over our 43-year history to use our growth to invest in our staff and expand our collective ability to make a real difference in human health. Christine understands our dedication to science, integrity, and human health. She understands that our employees are our most important asset and that high-quality research design, execution and results are our most important deliverable.”</p>
<p>“I’m honored to have the opportunity to become the next CEO of this extraordinary company,” said Dr. Dingivan. “Emmes’ reputation for exceptional research stems from the high standards they set – as individuals, teams and as a company. They have a clear sense of pride in the important work that they do.”</p>
<p>She added, “I felt drawn as a physician to Emmes’ commitment to advance public health. It was clear, both in my prior dealings with the company and now, that its people are passionate about tackling some of the biggest challenges to human health. I am so excited about joining a company whose mission and values are so closely aligned with my own.”</p>
<p>Dr. Dingivan trained in general surgery at Northwestern Medical School, received her M.D. from Dartmouth Medical School, and holds a B.S. in bioengineering from the University of Pennsylvania. In addition to serving on the board of directors of two life sciences companies, Dr. Dingivan is dedicated to nonprofit work. An active member of the Washington, D.C. area community, she is a member of the Kennedy Center National Symphony Orchestra’s board of directors and is a founding board member of Young Women Lead (YWL), whose goal is to empower high school girls and offer leadership, education, and development experiences and resources.</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;

08/12/2020

Company News

<p>Three Employees Co-Author Preliminary Report for the New England Journal of Medicine.</p>
<p>Emmes today announced that it provided the data and statistical analysis support for the Phase 1 clinical trial of the investigational COVID-19 vaccine mRNA-1273. Three Emmes employees were co-authors on the Preliminary Report about the clinical trial, “An mRNA Vaccine against SARS-CoV-2,” published in the New England Journal of Medicine on July 14.</p>
<p>The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician. </p>
<p>According to Albert, “Emmes launched the trial’s electronic data collection system in about a month. Our team was driven to do everything we could to contribute to this critical human health challenge.”</p>
<p>The vaccine was co-developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and at Moderna, Inc., which was involved in trial design discussions and provided the vaccine candidate. Emmes served as the statistical and data collection and coordination center, developed the statistical analysis plan, and performed the analysis. </p>
<p>The Phase 1 trial began in March 2020 to determine the safety of the mRNA-1273 vaccine and its ability to induce an immune response. The open-label trial included 45 healthy adults, ages 18 to 55, who received two vaccinations, 28 days apart. The vaccine resulted in anti-SARS-COV-2 immune responses in all participants, and there were no trial-limiting safety concerns.</p>
<p>“It has been a privilege to collaborate with Moderna and with NIAID in developing a vaccine for COVID-19,” said Dr. Anne Lindblad, Emmes president and chief executive officer. “The successful Phase 1 trial has paved the way for the subsequent clinical trials.”<br />
The company has supported research for infectious diseases such as H1N1 influenza, SARS, Ebola and Zika, among others, and now for COVID-19.</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;

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;