Emmes is excited to share the significant progress being made in clinical studies.
We also give you a look inside some of our own news.
Emmes Announces New Role for the Blood and Marrow Transplant Clinical Trials Network
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.
Emmes Announces New Role for the Blood and Marrow Transplant Clinical Trials Network
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.
Emmes Selected as an Area Top Workplace by The Washington Post for a Fifth Year
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.
Emmes Announces Acquisition of UK-Based Orphan Reach
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.
Rhonda Henry Named President of Emmes’ BioPharma Group
Company News
Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Rhonda Henry has joined the company as President of Emmes BioPharma.
“Naming a leader of our biopharma group is a major, positive step in our strategy to expand and diversify our business,” said Dr. Christine Dingivan, Chief Executive Officer of Emmes.
Henry joins Emmes with 30 years of clinical research experience, most recently as vice president of patient solutions at PPD. One of the largest clinical research companies in the world, PPD has about 24,000 employees working in 46 countries. She began her career there as a clinical research associate in 1991 and gained increasing responsibilities in a number of management positions, including director of hematology/oncology. Henry was one of only 14 individuals selected to participate in PPD’s first global leadership program in 2004.
In 2020, she was named to the PharmaVOICE 100 list of most inspiring people working in the life-sciences industry.
Before joining PPD, she spent eight years at the New Hanover Regional Medical Center in Wilmington, NC, starting as a phlebotomist and completing her tenure there as a nurse in medical/surgical and neurology areas.
According to Henry, “Two of the things that attracted me to Emmes were its excellent reputation and its 40+ years in clinical research. The opportunity to work with Christine again, along with the conversations I had with members of Emmes’ leadership team, had a big impact on my decision.
“I look forward to building upon Emmes’ long-established relationships with government clients as we develop new client opportunities with biotech and pharmaceutical companies, from smaller, private firms to large, public companies,” she continued.
Emmes’ Biopharma group was given a boost with the company’s acquisition of Neox this past December. A CRO operating in 19 European countries, Neox added about 150 employees and significantly expanded Emmes’ international presence and biopharmaceutical client base. Emmes is continuing to invest in growing this business, both internally and through acquisitions.
According to Dr. Dingivan, “I’ve worked closely with Rhonda for many years in roles across clinical operations and as sales management, and I know that her values, personality and depth of CRO experience make her the perfect leader for Emmes’ growing biopharma business. ”
She added, “Rhonda also brings a deeply rooted commitment to patient advocacy. Her nursing experience brought a very valuable perspective to her clinical research work at PPD, and it’s no surprise that one of her titles included the words, patient-centered trials. The depth of Rhonda’s clinical research experience, her understanding of the therapeutic areas that Emmes is well known for, and her demonstrated success in leading business development functions will make her an outstanding addition to our team.”
Henry holds a B.S. in nursing from the University of North Carolina, Wilmington. She has been active in a number of non-profit organizations, including serving as a volunteer board member for The Carousel Center, which provides advocacy and services for children who have been affected by physical or sexual abuse. She and her husband, who have three children and one grandchild, live in Wilmington, NC.
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.
The pandemic revved up business for Emmes CEO Christine Dingivan. So she found balance with yoga.
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
The pandemic revved up business for Emmes CEO Christine Dingivan. So she found balance with yoga.
Company News
<p><em>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.</em></p><p><em>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.</em></p><p><em>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.</em></p><p><em>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."</em></p><p><strong>How has the pandemic affected your growth?</strong><br />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.</p><p><strong>How did 2020 change you as a leader?</strong><br />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<br />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.</p><p><strong>What has helped you get through this period?</strong><br />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<br />couple days a week every week, religiously, for a year. It’s been wonderful.</p><p><strong>What changes have you made over the past year?</strong><br />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<br />socialize with your neighbors when you’re walking the dog and all of a sudden you have a new social network.</p><p><strong>What’s something most people don’t know about you?</strong><br />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.</p><p><strong>How do you spend your free time?</strong><br />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<br />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.</p><p><strong>How has Covid affected that part of your life?</strong><br />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<br />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.</p><p><strong>Have you found another outlet?</strong><br />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.</p><p><strong>What was your last flight before the pandemic hit last March?</strong><br />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.</p><p><strong>What’s on your post-pandemic bucket list?</strong><br />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<br />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.</p><p><strong>The basics</strong></p><p><strong>Dr. Christine Dingivan</strong><br /><strong>Title:</strong> President and CEO, Emmes<br /><strong>Age:</strong> 54<br /><strong>Education:</strong> 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<br /><strong>Residence:</strong> Naples, Florida; since taking the job at Emmes, she’s been working from McLean.<br /><strong>First job:</strong> Delivering newspapers in junior high school</p><p> </p><p><strong><span style="left: 150.667px; top: 439.98px; font-size: 13px; font-family: sans-serif; transform: scaleX(1.10139);">Sara Gilgore</span></strong></p><p><span style="left: 150.667px; top: 459.032px; font-size: 13px; font-family: sans-serif; transform: scaleX(1.1078);">Staff Reporter</span><br /><span style="left: 150.667px; top: 477.705px; font-size: 13.4001px; font-family: sans-serif; transform: scaleX(1.04703);">Washington Business Journal</span></p>
Emmes Employees Co-Author Substance Use Article for the New England Journal of Medicine
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" 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>
Emmes Employees Contribute to New England Journal of Medicine Report on Pregnant Women with Epilepsy
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/" 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>
Emmes Leads Clinical Trials to Improve Pediatric Drug Labeling
Company News
<p>Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced significant progress in its role as Data Coordinating Center for studies conducted under the <a href="https://www.nichd.nih.gov/research/supported/bpca/accomplishments" target="_blank">Best Pharmaceuticals for Children Act (BPCA)</a>.</p>
<p>Results from the Emmes-managed clinical trials, conducted through the BPCA Clinical Coordinating Center at <a href="https://pediatrictrials.org/" target="_blank">Pediatric Trials Network</a>, contributed directly to improved drug labeling for a range of products used in treating infants and children. The four newest label changes related to caffeine citrate, used to treat apnea of prematurity, plus three antibiotics: doxycycline, clindamycin, and trimethoprim-sulfamethoxazole (often referred to by its trade name Bactrim™). With the revised labeling for Ampicillin, announced early last year, there were a total of five Emmes-supported label changes during 2020.</p>
<p>According to Ravinder Anand, Ph.D., Emmes’ Vice President of Maternal Child Health, “These are the most approvals ever gained in a single year under the BPCA program. We are proud of our role in these accomplishments for our client, the National Institute of Child Health and Human Development (NICHD).”</p>
<p>He added, “The improvements associated with these label changes provided weight base dosing recommendations for clindamycin; information on pediatric pharmacokinetics for doxycycline and Bactrim; and a broader treatment-eligible age range and extended treatment duration when using caffeine to treat premature infants with apnea of prematurity.”</p>
<p>Under the NICHD contract, Emmes provides end-to-end clinical study support and management, which includes data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses for the studies. The company has served as the Data Coordinating Center for the BPCA program since August 2009 and has supported 11 labeling and two other marketing approvals from the <a href="https://www.fda.gov/drugs/development-resources/nih-funded-pediatric-la…; target="_blank">U.S. Food and Drug Administration (FDA)</a>. These changes have addressed either pharmacokinetics, dosage, safety and/or efficacy information for a variety of pediatric drugs and devices across various pediatric populations and treatment indications.</p>
<p>Emmes’ Chief Executive Officer, Dr. Christine Dingivan, said, “These drug labeling approvals reinforce our commitment to excellence in study design, execution and analysis. This is an important public sector program and a valued client. Emmes has a long history of pediatric clinical research, and our team is so proud of our role in improving public health outcomes and safe, effective drug development in children.” </p>
<p><strong>About the Research</strong><br />
The BPCA program is funded by the National Institutes of Health through its Eunice Kennedy Shriver National Institute of Child Health and Human Development. This program supports the Pediatric Trials Network, which studies commonly prescribed off-patent drugs whose original development did not include pediatric patients. Study results are intended to amend FDA-approved prescribing information. This project has been funded in whole or in part with Federal funds from the National Institutes of Health under Contract No. HHSN275201700002C.</p>
<p><strong>About Emmes</strong><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>
