09/20/2021

Company News

Emmes and Veeva Systems (NYSE: VEEV) today announced that Emmes is standardizing on Veeva Development Cloud applications across functional areas to enable greater speed and compliance. The company will use applications in Vault Clinical, Vault Quality, and Vault Safety suites to establish a technology foundation for delivering clinical research and pharmacovigilance services to its global customers.

“Our strategic partnership with Veeva empowers us to streamline how we work, improve visibility and oversight, and run faster, more cost-effective research programs,” said Dr. Christine Dingivan, chief executive officer at Emmes. “Using agile and scalable cloud solutions is a strategic priority for Emmes since we are growing rapidly and expanding into new markets. Veeva Development Cloud will enhance collaboration with sponsors and sites and help us keep up with evolving regulatory requirements.”

Building on its experience across more than 2,000 clinical trials, Emmes is making significant investments in people and technology to deliver focused offerings for biopharmaceutical and public sector clients. Adopting Veeva Development Cloud applications will enable them with real-time information on a single, connected platform to drive better cross-team visibility and execution.

“Emmes shares our vision of connected drug development and together, we’re helping advance the industry toward better collaboration and speed across the product lifecycle,” said Jim Reilly, vice president of Veeva Vault R&D. “Veeva Development Cloud eliminates system and process siloes so companies can focus on innovation and accelerate the delivery of products to patients.”

Emmes is standardizing on clinical applications Vault CTMS, Vault eTMF, Vault Study Start-up, and Vault Payments, quality applications Vault QMS and Vault QualityDocs, and safety application Vault Safety. Looking ahead, the company plans to add Vault Training, Vault SafetyDocs, and regulatory applications Vault Submissions, Vault Submissions Publishing, and Vault Submissions Archive.

Learn more about Veeva Development Cloud at the upcoming Veeva R&D and Quality Summit Connect, October 14, 2021. The online event is open to life sciences industry professionals. Register and stay up to date on program details at veeva.com/Summit.

Additional Information
For more on Veeva Development Cloud, visit: veeva.com/DevelopmentCloud
Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems
Follow @veevasystems on Twitter: twitter.com/veevasystems

About Emmes
Founded in 1977, Emmes is a global, full-service clinical research organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical, and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,100 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com.

Forward-looking Statements
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly within the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-Q for the period ended July 31, 2021. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

Contact:    

Deivis Mercado
Veeva Systems
925-226-8821
deivis.mercado@veeva.com

Dana Dever
Emmes
301-251-1161
ddever@emmes.com

08/02/2021

Company News

Emmes today announced that it launched a new study assessing the durability of response to COVID-19 vaccinations in patients with hematological malignancies who are undergoing cellular therapies, such as blood or marrow transplantation or CAR-T infusions. The study is part of an expanded portfolio of projects conducted under the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The study is supported by National Marrow Donor Program (NMDP)/Be The Match®, The Leukemia & Lymphoma Society (LLS), the National Heart, Lung, and Blood Institute (NHLBI), the National Cancer Institute (NCI), the Fred Hutchinson Cancer Research Center, the Multiple Myeloma Research Foundation (MMRF), American Society for Transplantation and Cellular Therapy (ASTCT), LabCorp, and Adaptive Biotechnologies.

Emmes has partnered with the Center for International Blood and Marrow Transplant Research (CIBMTR) and NMDP/Be The Match to develop and implement a study enrolling patients and collecting samples to determine how these immunocompromised patients respond to the COVID-19 vaccines. Emmes, the CIBMTR and NMDP/Be The Match collaborated to design a streamlined data collection strategy that uses the company’s proprietary Advantage eClinical system with standard data collected as part of the CIBMTR registry. The result: an efficient data collection strategy that was deployed in record time.

Adam Mendizabal, Ph.D., Emmes vice president and co-director of the Emmes Transplant Research Unit, said, “ Because patients who have received cellular therapies have diminished responses to other vaccines, the study will help determine if this also applies to COVID-19 vaccines.”

Mendizabal noted, “I am proud of the Emmes team, along with our collaborators at the CIBMTR and NMDP/Be The Match, for organizing a study plan, raising funds, and enrolling patients in record time. The support of our clinical colleagues across the United States has been critical to our success.”

Krisy Peyton, Emmes project leader, added, “We were ready to launch the study in only one month, and we have already made key changes to the system under tight timelines to accommodate new requirements and expanding needs.”

She continued, “Our history of successful collaborations with the BMT CTN, combined with deep subject matter expertise on the part of our Emmes project team, were critical components of a rapid, successful launch.”

The study aims to follow 732 patients who have received hematopoietic cell transplantation (HCT) and chimeric antigen receptor (CAR) T-cell therapy in the last 12 months and who are scheduled to receive a COVID-19 vaccination as part of their standard of care.

The 732 patients enrolled in the study will be in six cohorts defined by type of cellular therapy and timing of vaccination. The primary objective is to compare the immunogenicity of COVID-19 vaccines in patients starting their vaccination course less than six months after HCT/CAR T-cell therapy versus those starting the vaccination course six to 12 months after the therapy.

Findings from the study will provide physicians with evidence-based guidance and recommendations about COVID-19 vaccinations for their transplant patients.

Dr. Christine Dingivan, Chief Executive Officer of Emmes, said, “Over the last year, Emmes team members have been dedicated to supporting or conducting clinical trials associated with the accelerated development of safe and effective COVID-19 vaccines and therapies. This work has required tight deadlines, intensive effort and creativity, particularly in conducting remote patient trials.

“This new work is no exception,” she added. “It demonstrates that there will be a continued need for research that addresses very specific sets of the population and their responses to COVID-19 vaccines. Emmes is proud to collaborate with the Blood and Marrow Transplant Clinical Trials Network, the CIBMTR and the strong coalition of partners involved in this project.”

About Emmes

Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

About the BMT CTN

The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving cellular therapies. The BMT CTN has completed accrual to 46 Phase II and III trials at more than 100 transplant centers and enrolled over 14,600 study participants.

BMT CTN is funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute, both parts of the National Institutes of Health (NIH), and is a collaborative effort of 20 Core Transplant Centers/Consortia, The Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Donor Program (NMDP)/Be The Match and the Emmes Company, LLC, a clinical research organization. CIBMTR is a research collaboration between the NMDP/Be The Match and the Medical College of Wisconsin. Together with MCW/ CIBMTR and NMDP, Emmes has been providing research support to the BMT CTN since 2001, as a key member of the data coordinating center.

More information about the BMT CTN can be found at www.bmtctn.net.

About CIBMTR

The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW). The CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide to increase survival and enrich quality of life for patients. The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of transplant centers, and a unique and extensive clinical outcomes database. For more information on the CIBMTR, please visit www.cibmtr.org or follow the CIBMTR on Facebook, LinkedIn, or Twitter at @CIBMTR.

06/24/2021

Company News

Emmes today announced that it was selected as one of the best places to work in the greater Washington area. This is the fifth time that the company has been chosen as a top workplace by The Washington Post, whose rankings are based on the highest employee engagement ratings.

The Post’s 2021 Top Workplaces list included a wide range of organizations, including government contractors, law and real estate firms, professional and business services firms, and technology companies.

The Post partnered with employee engagement firm Energage, LLC, to conduct the survey, asking employees about the companies they work for on topics ranging from employee development to innovation. More than 3,500 area companies were invited to participate, representing over 65,500 employees. Emmes was selected as a top workplace in the large company category.

Chief Executive Officer Dr. Christine Dingivan said, “We partner with our public sector and biopharma clients to conduct clinical trials and research studies that determine whether a new medicine or vaccine is safe and effective. We never forget that it is a privilege to be a part of such important work. It brings us great pride that Emmes employees involved in six studies this past year, including COVID-19 vaccines and therapies, co-authored articles about the findings in the prestigious New England Journal of Medicine.”

She added, “What our 1,000+ employees share is one common goal: to truly make a difference in public health throughout the world. This mission and our purpose-driven employees make Emmes a unique company. Our two recent acquisitions have accelerated our growth and diversification, not only throughout Europe and the UK but also across both public sector and biotech/pharmaceutical clients.”

Emmes has hired over 100 people so far in 2021 and is actively recruiting to fill more than 70 openings in the D.C. area and worldwide.

Earlier this spring, Emmes was ranked as the fifth largest bioscience employer in the greater Washington area by the Washington Business Journal.

About Emmes
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

05/12/2021

Company News

Company’s Second Major Acquisition Will Extend Orphan and Rare Disease Research Base and Growth Opportunities

Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Orphan Reach, a company headquartered in the United Kingdom with offices in Ireland, Germany, India, Canada, and the U.S.  Started nearly 20 years ago, Orphan Reach is a CRO dedicated to clinical research in rare diseases.

This is Emmes’ second acquisition in the past four months, following the acquisition of Neox s.r.o., an EU-based CRO, in December 2020.  Neox and Orphan Reach expand Emmes’ global reach with their international footprints and add a larger and more diverse set of biopharmaceutical clients.

According to Emmes Chief Executive Officer Dr. Christine Dingivan, “Our acquisition of Orphan Reach will accelerate our growth, establishing us as an industry leader in clinical research for orphan and rare diseases.  Orphan Reach has an outstanding reputation, with experience in 60 rare disease clinical trials and over 50 biopharma clients throughout the world.”

She continued, “We believe that Orphan Reach and Emmes will be highly synergistic; we will combine Emmes’ deep strategic drug development and advanced statistical capabilities with the exceptional patient-centered global operations experience of the Orphan Reach team.   With more than 7,000 rare diseases identified and only 400 treatments available, this represents a large research opportunity and demonstrates our commitment to advancing public health and addressing unmet medical needs for all populations.”

Orphan Reach Founder and CEO Thomas Ogorka said, “Orphan Reach and Emmes share a passion for the research we do, a dedication to the patients in our trials, and successful, long-term collaborations with our clients.  I look forward to this new chapter in our history and to further extending our leadership in rare and orphan disease research that leads to new treatment options for these patients.”

Ogorka and the company’s leaders will continue in their current roles.  

“I am looking forward to working with Thomas and the Orphan Reach team, particularly as we broaden their research opportunities in the United States,” added Dr. Dingivan.  “I am also very optimistic about collaboration between Orphan Reach and Neox and the potential for leveraging our growing global footprint and client relationships.”

Last month, the company announced that Rhonda Henry, a 30-year industry veteran, had been hired to become president of Emmes BioPharma, further reinforcing Emmes’ commitment to expand more aggressively in this market.  

About Orphan Reach
Headquartered in the United Kingdom, Orphan Reach has built a reputation for outstanding clinical research addressing rare diseases.  Created in 2002, the company has management teams in Europe, Asia and the U.S., and supports patients with rare diseases in more than 70 countries. The team’s goal is to accelerate access to new treatments in a wide range of orphan therapeutic areas.

About Emmes
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world.  To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

04/08/2021

Company News

Christine Dingivan’s first job delivering newspapers in junior high school was “a terrible experience,” she said, requiring a 2 a.m. wake-up call and, at times, her dad when her bike proved inefficient in Long Island, New York. Her dream to become a professional athlete also didn’t pan out, causing her family to encourage a pursuit in academics instead.
 

So she became a physician and started a career at MedImmune, followed by posts at North Carolina research company PPD Inc. and Switzerland pharmaceutical giant Novartis International. And she never looked back.

Today, Dingivan leads Rockville contract research organization Emmes which was founded in 1977. Since her start in September, she’s led the life sciences services firm through its first acquisition, the creation of a new biopharma business unit and an aggressive hiring push that could add another 200 people globally to its 1,000-person roster, up from 650 people last fall.

The company, which conducts research and runs clinical trials for a growing roster of government, biopharmaceutical, nonprofit and foundation customers, has only ramped up in the age of coronavirus, including providing data and statistical support for the first phase of Moderna’s Covid vaccine trials. “I have the opportunity to really help make a difference, add something to this effort to overcome the pandemic,” she said, “and I’m grateful for that."
 

How has the pandemic affected your growth?
The pandemic has had two main impacts on our business. One is, it’s actually grown our business. About 15% to 20% of our staff work on Covid-related studies. That’s a lot. We have close to 175 people that work on our Covid portfolio. No. 2 is supporting the remote workforce. We had to basically, overnight, procure and hand out over 500 laptops.

How did 2020 change you as a leader?
It has made me lean more on empathy and supportive behaviors with people, just trying to meet them where they’re at. Maybe not being as highly direct and
demanding, because maybe I have been in other roles. Because you do have to take into account everything your team is juggling and managing, in a way that you didn’t have to before. It kind ofhumanizes you a lot more as a leader, because you have those same challenges yourself.

What has helped you get through this period?
I finally, after all these years, took up yoga. It’s something I have always had my eye on. I finally found the right teacher, and I’ve been doing that a
couple days a week every week, religiously, for a year. It’s been wonderful.

What changes have you made over the past year?
We got a puppy! A Cavapoo. I think we were all just looking for something joyful, kind of new in our lives, so that was part of it. And it’s a way to
socialize with your neighbors when you’re walking the dog and all of a sudden you have a new social network.

What’s something most people don’t know about you?
I love photography. I’m crazy about taking pictures and adventure travel, to allow me to take interesting pictures of different places.What else? I own an RV now and I’m quite capable of operating it. It’s shocking to people because I am such a hotel brat. I’m very selfreliant, but when I go to a hotel, I want to go to a really nice hotel. I just want to live the dream, because my day-to-day life is not like that. But when people hear that I’m now driving and maintaining an RV, they just break out in laughter.

How do you spend your free time?
I really love the arts. Most people think of me as a science and math person, but I love the arts, music. I’m really so impressed with people who have those
gifts, that they can play an instrument or their voice or their ability to act. That’s largely what I do in my free time, before the pandemic of course, to take in the arts.

How has Covid affected that part of your life?
I’ve missed it. I’m on the board of the Kennedy Center and they offer these streaming events and they’ve opened up their historical library that you can
access remotely, so I’ve done a little bit of that. But it’s really not the same as being in the concert hall. It was always such a special experience to go there, and I really miss that.

Have you found another outlet?
I finally took on a family project to organize all of our pictures. Going back to my grandparents. It’s a massive undertaking — there are thousands of these in boxes, and some of them are in slide format because that was really popular for a while in the ’50s, ’60s and ’70s even. So that was my artistic expression, because I’m now putting together photo albums.

What was your last flight before the pandemic hit last March?
I remember it like it was yesterday. It was a flight from my house in Naples, Florida, to DCA on JetBlue. We came directly from the airport, dropped off our suitcases and went out to eat, and that’s the last time I ate in a restaurant. Capri, in McLean. I still have the credit card receipt.

What’s on your post-pandemic bucket list?
I dream about it all the time. I have a voucher for a trip I booked to take a cruise to Antarctica. It also had to be canceled, so you had two choices: You
could get your money back or they gave you all these incentives if you took a voucher. I just want to hop on a plane and go to Europe again. Go to Italy, because I’m dying to have some Italian food in Italy. And visiting family, because we really have missed each other.

The basics

Dr. Christine Dingivan
Title: President and CEO, Emmes
Age: 54
Education: Bachelor’s in bioengineering, University of Pennsylvania; M.D., Dartmouth College’s Geisel School of Medicine; trained in general surgery at Northwestern University’s Feinberg School of Medicine
Residence: Naples, Florida; since taking the job at Emmes, she’s been working from McLean.
First job: Delivering newspapers in junior high school

Sara Gilgore

Staff Reporter
Washington Business Journal04/08/2021

02/22/2021

Company News

<p>Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its contribution to a <a href="https://www.nih.gov/news-events/news-releases/combination-treatment-met…; target="_blank">study</a> for the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) and a related <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2020214&quot; target="_blank">article</a> published in the New England Journal of Medicine. </p>
<p>Emmes statisticians Gaurav Sharma, Ph.D., and Aimee Wahle were co-authors of the article, “Bupropion and Naltrexone in Methamphetamine Use Disorder.”</p>
<p>The double-blind, placebo-controlled Phase III clinical trial centered on the use of a combination treatment for adults with moderate or severe methamphetamine use disorder. The study, known as the Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (ADAPT-2), evaluated the efficacy and safety of two medications, injectable naltrexone and oral bupropion. Study participants who received the combination treatment showed a higher response rate than those who received placebo. </p>
<p>“The study findings are cause for optimism,” said Jennifer McCormack, Associate Vice President who leads Emmes’ substance use disorder unit. “The combination of the two medications was shown to be safe and effective, and we now have a strong platform for more research to address the growing methamphetamine crisis in the U.S.”</p>
<p>She continued, “Our clinical trial design team implemented a sequential parallel comparison design, an innovative design that required re-randomization of placebo non-responders in the second stage of the study. We believe the experience of implementing this adaptive design will prove useful in designing future studies of substance use disorder.”</p>
<p>The Emmes project team provided the full-scope support through its Data and Statistics Center and Clinical Coordinating Center contracts with NIDA. The company has collaborated with NIDA on more than 50 clinical trials since 2005.</p>
<p>Paul VanVeldhuisen, Ph.D., President of Emmes Public Sector, noted, “Although opioid use disorder has deservedly received a lot of attention, methamphetamine use disorder is also a serious, growing concern, and it is difficult to treat.”</p>
<p>According to a study published in JAMA Psychiatry, methamphetamine overdose deaths surged in an eight-year period in the United States. It is a leading cause of overdose deaths in the Midwest and West. </p>
<p>“The pandemic has intensified concerns about substance use disorders, making treatments even more critical,” Dr. VanVeldhuisen added. “There are currently no medications for treating methamphetamine use disorder that are approved by the U.S. Food and Drug Administration, so the results of the NIDA CTN study are especially encouraging.”</p>
<p>“I’m very proud of the innovative approach that our team implemented to advance critical research addressing this public health crisis,” noted Dr. Christine Dingivan, Chief Executive Officer. “It is a wonderful example of Emmes’ experience and commitment to the important work of clinical trials in the area of substance use disorders.”</p>
<p>About the Research<br />
This project has been funded in whole or in part with Federal funds from the National Institutes of Health under Contracts No. HHSN271201400028C and HHSN271201500065C.</p>
<p>About Emmes<br />
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

02/08/2021

Company News

<p>Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced the company’s involvement in a recent article published in the New England Journal of Medicine. Emmes’ Carrie Brown and Dr. Steffanie Wilson were among the team of researchers who contributed to the <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2008663?rss=searchAndBrowse…; target="_blank">article</a>, “Changes in Seizure Frequency and Antiepileptic Therapy during Pregnancy.” </p>
<p>“The research addressed the important issue of how to care for women with epilepsy during pregnancy and postpartum,” said Dr. Wilson, who leads Emmes’ neurology and mental health research unit. “It is one of the first studies to compare seizure frequency of pregnant women with epilepsy with a non-pregnant control group. An immediate goal was to assess the impact of anti-epileptic drugs and dose management on seizure frequency during compared to after pregnancy.”</p>
<p>One conclusion of the study was that the percentage of women with epilepsy with a higher incidence of seizures during pregnancy was similar to that in women with epilepsy who were not pregnant. The study findings suggest pregnancy may not make seizures worse among women with epilepsy whose seizure medication is carefully managed. These findings are significant because women with epilepsy have, in some cases, been discouraged from getting pregnant because of the lack of available data on the effect of pregnancy on seizure control. </p>
<p>According to Dr. Wilson, researchers are continuing to collect data about the use of anti-epileptic drugs by pregnant women and the impact on the health of their children.</p>
<p>The Emmes data and statistical coordinating center team, led by Principal Investigator Dr. Abigail G. Matthews, has provided clinical research support for the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) <a href="https://web.emmes.com/study/monead/&quot; target="_blnak">study</a> since the end of 2012. The study is funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.</p>
<p>The company provided similar support for the predecessor study, Neurodevelopment Effects of Antiepileptic Drugs (NEAD), which ran from 1999 to 2004. The NEAD study had addressed the effects of in utero exposure to a number of different antiepileptic drugs on children. The current MONEAD work is addressing several research focuses stemming from that work, including the longer-term effect of anti-epileptic drugs on the study participants’ children, as well as rates of obstetrical complications, among others. The Emmes team’s involvement in both studies has spanned more than 13 years, and the current study period extends through 2023. </p>
<p>“The MONEAD study findings have also been presented at the American Epilepsy Society Annual Meeting and recognized in other high-impact journals, such as Lancet and Lancet Neurology,” noted Emmes’ Chief Executive Officer Dr. Christine Dingivan. “This important work underscores our commitment to public health, and we are proud to continue expanding the body of knowledge about epilepsy and its impact on pregnant women and their children.”</p>
<p>About the Research<br />
This project has been funded in whole or in part with Federal funds from the National Institutes of Health/National Institute of Neurological Disorders and Stroke under Grant No. U01-NS038455.</p>
<p>About Emmes<br />
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

01/21/2021

Company News

<p>Dr. Christine Dingivan has stood in the top slot at Emmes for fewer than four months. In that time, she's led the Rockville life sciences services firm through its first acquisition and split the business into two units to, she said, better position it for further growth.</p>
<p>And there’s more to come.</p>
<p>The company, Dingivan said, “will greatly exceed” its 2020 pace of hiring in 2021, even with its December acquisition of Neox, a European contract research organization headquartered in Prague, for undisclosed terms. Between the employees it brought on through that purchase and demand for its services rising due to the pandemic — Emmes conducts research and clinical trials for public and private sector customers — the company swelled from roughly 650 people last fall to more than 1,000 today. </p>
<p>“We will easily be adding 200 or more individuals to the company, and the majority will be in the U.S,” said Dingivan, president and CEO.</p>
<p>The local company's purchase of Neox expanded its international presence into central and eastern Europe — a “completely complementary” geographical footprint, the CEO said. Emmes currently has offices in Canada and Bangalore, India, but says it has conducted clinical trials and services in 60 countries across six continents.</p>
<p>The 150 new workers coming on board through the acquisition “are really going to be able to bolt on and tuck in quite nicely, so it’s competitive for us,” Dingivan said. “Certainly, they have staff in countries where we have none — it’s a total additive capacity and expertise for us.”</p>
<p>For Neox, the agreement opens its door to U.S. customers and clinical trials for the first time. Neox’s co-founders, brothers Dr. Pavel Marek and Petr Marek, will remain with the combined company — which expects to grow its client roster further, Dingivan said. “From a sales perspective, it’s also an accelerant for us,” she added.</p>
<p>Neox, meanwhile, now becomes part of Emmes Biopharma, one of two new divisions Dingivan put into place in December to target and serve more biopharmaceutical clients. The company is now recruiting for a president of that group; Emmes recently promoted longtime employee Dr. Paul VanVeldhuisen to lead its other entity, Emmes Public Sector, which will focus on its work with government clients.</p>
<p>“We wanted to make sure we were being completely, fully compliant with everything required to be a government contractor,” she said. “So having some clear separation also helps us there.”</p>
<p>The changes come as Emmes continues its involvement in a clinical trial of rheumatoid arthritis drug baricitinib in combination with remdesivir, which received federal emergency use authorization in November for patients with coronavirus. More than 100 Emmes employees are involved in that work, which Dingivan said is “a huge piece of the company’s efforts” for revenue and man-hours. “It’s still a very active program for Emmes, far from over,” she said.</p>
<p>As for the future, she said the company is making “significant investments” in its technology, including launching a new customer relationship management system, evaluating new clinical trial systems and implementing a new safety regimen slated to launch in the first quarter of this year, Dingivan said.</p>
<p>“That’s an evolving and new story for Emmes, one that I’m going to be driving really hard in ’21,” she said. She declined to disclose a specific investment amount, describing it as “meaningful, and it’s the most ever by the company.”</p>
<p>The business plans to charge forward with more acquisitions, both to expand geographically but also in specialty therapeutic areas within public health, such as pediatrics, Dingivan said.</p>
<p>“I believe very strongly that public health is not just a public sector activity with the government, but it’s also an important part of what biopharmaceutical innovation can do,” she said, citing Pfizer’s and Moderna’s Covid vaccines as examples.</p>
<p>“Going forward with the vaccinations starting to make their way out into the public, we’re anticipating the pressure on our business that we need to respond to will hopefully lighten a bit in 2021 and going forward,” she said. “So if we were able to do well in 2020, it really speaks to how well we are positioned for 2021 and beyond.</p>
<p><strong>Sara Gilgore</strong><br />
Staff Reporter<br />
Washington Business Journal</p>

01/11/2021

Company News

<p>Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that long-time employee, Dr. Paul VanVeldhuisen, has been named President of Emmes Public Sector.</p>
<p>Emmes is now organized into two business groups: Emmes Public Sector and Emmes Biopharma. The public sector group includes all the company’s existing federal government clients and contracts, as well as work for foundations, public/private sector partnerships, and not-for-profit organizations.</p>
<p>The Emmes Biopharma group is further strengthened by Emmes’ recent acquisition of Neox, a CRO headquartered in the Czech Republic with operations in 19 European countries. Neox significantly expands Emmes’ international presence and client base across biotechnology, pharmaceutical and medical device companies.</p>
<p>According to Emmes’ Chief Executive Officer, Dr. Christine Dingivan, “Our public sector work is extremely important to the company, from the standpoint of its history, its long and successful client relationships, and its contribution to growth. We are thrilled to have Paul at the helm.”</p>
<p>She added, “Paul is uniquely qualified to head Emmes Public Sector. He is a widely respected researcher and leader, both within and outside of Emmes. He led Emmes research teams in such wide-ranging areas as substance use, eye disease, and maternal and child health. He has held senior leadership roles at the company for the past 15 years. He is thoughtful and insightful, adding great value and counsel to me and other members of our leadership team.”</p>
<p>“It’s an honor to lead Emmes Public Sector,” said Dr. VanVeldhuisen. “My role is new, but our work with the federal government goes back to Emmes’ creation in 1977. I’ve spent my career here at Emmes. It’s a remarkable place to work because my colleagues share a passion for the research we do. My goal is to build upon our excellent reputation, expanding our government base and adding to our portfolio of work with existing partners as well as reaching new partners across the public sector.”</p>
<p>Dr. VanVeldhuisen has over 25 years of experience in clinical research. After joining Emmes in 1993, he designed and conducted clinical trials, and later became a principal investigator. He was promoted to vice president in 2006 and chief operating officer in 2016. He holds a Ph.D. in epidemiology from The George Washington University, an M.S. in biostatistics from the University of Washington, and a B.S. in mathematics from Calvin University. </p>
<p>About Emmes<br />
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at <a href="http://www.emmes.com">www.emmes.com</a>.</p&gt;

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;