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 Supports Groundbreaking Anal Cancer Study Sponsored by the National Cancer Institute
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Treatment of Precursor Lesions Was Found to Significantly Reduce the Risk of Progression to Anal Cancer, with Study Results Highlighted in the New England Journal of Medicine
Rockville, MD – June 16, 2022 – Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that a team of its researchers contributed to a successful AIDS Malignancy Consortium (AMC) study. Results of the study, which demonstrated that treating and removing anal cancer precursor lesions reduced the cancer risk for HIV-infected men and women, were published in the New England Journal of Medicine. The Phase 3 trial results included 4,446 participants at 21 clinical sites across the U.S. and Puerto Rico.
The study enrolled people living with HIV aged 35 years and older who had at least one precursor lesion for anal cancer, called high-grade squamous intraepithelial lesions (HSIL). Participants were randomized into two groups: those who received treatment for the lesion(s) and those who were actively monitored but did not receive treatment. Participants were re-evaluated every three to six months. Rates of progression to anal cancer were compared between the two groups. The findings showed that treating HSIL resulted in a nearly 60 percent reduction in anal cancer progression among people living with HIV.
Emmes’ role was to coordinate the research, which included protocol development, electronic data capture, site monitoring, and regulatory compliance, along with general study management for the research team.
The National Cancer Institute’s Office of HIV and AIDS Malignancy sponsored the current study through the AMC, which was led by Joel Palefsky, MD, of the University of California San Francisco (UCSF).
Don Vena, vice president and head of Emmes’ oncology therapeutic research unit, said, “Dr. Palefsky facilitated collaboration among varied stakeholders – government, industry, labs, clinical sites and our team – to build the research infrastructure needed to run a landmark trial in the developing field of anal cancer prevention. Emmes is proud to have been a contributor and proud of our 18-year relationship with the AMC.”
Dr. Palefsky, who created the world’s first clinic devoted to anal cancer prevention at USCF in 1991, reported that the data from the ANal Cancer/HSIL Outcomes Research (ANCHOR) study show for the first time that anal cancer can be prevented in high-risk populations, such as people living with HIV. He shared that the results are likely relevant for other groups at high risk of anal cancer, such as people who are immunosuppressed for reasons other than HIV, and women with a history of cervical or vulvar cancer, even though the study focused exclusively on those with HIV.
He presented the study highlights on February 15 at the Conference on Retroviruses and Opportunistic Infections, a highly regarded event for HIV/AIDS research that attracts infectious disease scientists and professionals from around the world. He noted that office-based electrocautery not only resulted in the reduction in anal cancer incidence but that the treatment was well-tolerated.
According to Dr. Palefsky, “Anal cancer is the fourth most common cancer among people living with HIV. Primary prevention of this disease can occur in the long-term, for those with little or no history of sexual activity, with the use of the human papillomavirus (HPV) vaccine. Unfortunately, many people have already been exposed to HPV, are over the age of vaccination, or do not have access to the vaccine. For these individuals, the ANCHOR study shows for the first time that secondary prevention of anal cancer is possible through treatment of anal HSIL. We expect that the results of the ANCHOR study will lead to adoption of screening and treatment of anal HSIL in people living with HIV as the standard of care.”
Dr. Palefsky added, “The Emmes team played a key role in the success of the study through its diligent oversight and implementation of the many components of such a complex trial.”
Dr. Christine Dingivan, Chief Executive Officer of Emmes, commented, “We are extremely pleased that the ANCHOR study showed that HSIL treatment is effective in reducing anal cancer risk, and it ultimately will have a profound effect on patients’ quality of life. This project reflects how client tenure and close collaboration can make a big difference in public health – for people with HIV or at highest risk of anal cancer and for others in the future.”
About the Research
This project has been funded with federal funds from the National Cancer Institute’s Office of HIV and AIDS Malignancy under Grant No. #UM1CA121947.
About Emmes
Founded in 1977, Emmes is a global, full-service CRO 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 Supports Landmark mRNA COVID-19 Vaccine Trial in Sub-Saharan Africa
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Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it is providing data, statistical analysis, and project management support for new research that will test the Moderna mRNA vaccine at more than 50 sites in South and East Africa.
The clinical trial, which will include about 15,600 participants, seeks to better understand infection and disease in immunocompromised populations in order to prevent severe COVID-19 and chronic SARS-CoV-2 infections and minimize the risk of transmission. The study will also address the COVID-19 mRNA vaccine’s resistance to the variants that have been detected in South Africa and surrounding countries.
An important focus of the study is to evaluate vaccine efficacy among people living with HIV, including the influence of prior infection and degree to which they are immunocompromised.
Emmes has partnered with the COVID-19 Prevention Network (CoVPN), with operations based at Fred Hutchinson Cancer Center, to conduct this research. Fred Hutch is the CoVPN operations center for vaccine studies and has conducted numerous HIV studies around the world in the past few decades as part of the HIV Vaccine Trials Network (HVTN). After the onset of the COVID-19 pandemic, Fred Hutch was selected as the CoVPN operations center to build upon the expertise and infrastructure of the HVTN. The National Institute of Allergy and Infectious Disease, part of the National Institutes of Health, and the Department of Health and Human Services are funding the study.
Emmes will provide the database, data management services, statistical support, project management coordination, and central safety monitoring support. The study includes participant enrollment, vaccination, and follow-up and is expected to last about 27 months. Subsequently, Emmes will conduct the data and statistical analysis, addressing the relative risks of COVID-19 and severe COVID-19. This part of the contract will conclude in September 2024.
According to Valerie Brown, Emmes’ project leader, “It is an honor for Emmes to join the COVID-19 Prevention Network and Fred Hutchinson Cancer Center in this important research. This has far-reaching public safety implications in the global effort to control the pandemic.”
The data produced from this clinical trial will allow COVID-19 mRNA vaccines to be utilized expeditiously in South Africa and other countries where the COVID-19 variants are spreading. The research will provide access to an early and highly effective option for controlling the pandemic in these countries, prior to the availability of a vaccine tailored to the resistant strain or strains.
Dr. Christine Dingivan, Chief Executive Officer of Emmes, said, “Our earlier research support for COVID-19 therapies and vaccines has now evolved to more specific sets of patients, from those who are immunocompromised to populations across the world where variants are now spreading. Over 20 percent of Emmes’ employees have worked on COVID-related projects this past year, and we are committed to continuing our efforts to build the body of knowledge that will ultimately result in an end to this pandemic.”
About Emmes
Founded in 1977, Emmes is a global, full-service CRO 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 launches Advantage eClinical as a standalone cloud native clinical technology platform
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The cloud platform will empower biotech companies and CROs with an integrated solution for clinical data management and is supported by Emmes specialist data management teams
Emmes – a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces that it will introduce to market its third generation version of Advantage eClinical at Society for Clinical Trials (SCT) in San Diego, May 15th – 18th. The cloud platform of Advantage eClinical will be available as a standalone software product after undergoing more than two years of development. The system has been specifically designed to provide fast study builds, greater flexibility, and insights to clinical trial sponsors of all sizes.
Advantage eClinical provides a fully integrated suite of data management applications backed by decades of domain expertise. The cloud platform includes apps for study design, electronic data capture (EDC), randomization and trial supply management (RTSM), patient-reported outcomes (ePRO), safety data and reporting, risk-based monitoring, source data verification, and specimen/shipment tracking. It will be offered as part of combined packages with data consultation services, or simply as a standalone software product.
“One of the challenges many smaller biotechs face in the market is they don’t have access to an integrated technology platform for their trials. Options are incredibly limited and expensive, and they are often inflexible and lack support. This is exactly what we have set out to address with our third-generation Advantage eClinical platform,” commented Hemang Maniar, Chief Information Officer at Emmes.
Advantage eClinical was developed by clinicians for clinicians and provides one of the most cost competitive and resource rich options available to sponsors. It delivers robust features that improve data quality, ease oversight of clinical trial operations, and reduce trial timelines and costs. The cloud platform builds on Advantage eClinical’s long history of supporting over 1,000 clinical trials, including several high-profile adaptive COVID-19 trials, and leverages these prior study designs as clone templates to empower customers with an expedited set-up.
Maniar added, “as a cloud-based multi-tenant system it is easier to ensure scalability, security and release updates quickly. What’s more, out of the box CDASH CRF libraries allow us to get studies up and running in only a few weeks. This addresses a major concern from sponsors who need to start collecting data ASAP to avoid any delays on trials. What we are also providing is tremendous flexibility, and the client can choose to build their modules alone or engage our experienced data teams to provide guidance. The combination of an integrated system built by experienced clinicians, flexible support, and cost-effective scale is unique in the current marketplace.”
Advantage eClinical has supported over 1,000 trials, for nearly one million patients in over 70 countries, spanning more than 31,000 clinical trial sites.
Notes to editors
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.
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Emmes and Casimir Announce Research About a Novel, Home-Based Assessment for Duchenne Muscular Dystrophy
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Casimir’s Duchenne Video Assessment Results Are Showcased in a New Paper
Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Casimir’s research on the development of the Duchenne Video Assessment (DVA) scorecards was published in PLOS ONE. Emmes acquired Casimir in March 2022, and the group is now part of Emmes’ Rare Disease Center, Orphan Reach™.
The DVA is a novel, home-based clinical outcome assessment that measures ease of movement among those with Duchenne muscular dystrophy (DMD) through identification of compensatory movement patterns. Caregivers video record patients performing specific movement tasks at home using a secure mobile application. The paper describes the development of the scorecards that DVA-trained physical therapists use to score the videos.
Casimir’s Marielle Contesse, research scientist, was the lead author, with Mindy Leffler, co-founder and president, and Christine McSherry, co-founder and chief executive officer, among the other co-authors.
A previous paper in Muscle & Nerve, authored by Contesse, Leffler and other Casimir researchers, presented research findings that demonstrated that the DVA is a reliable and valid tool for measuring ease of movement as an indication of disease severity in patients with DMD. The latest paper in PLOS ONE details the development of the DVA scorecards.
The PLOS ONE paper outlines the scorecard development research conducted with physical therapists who have extensive experience evaluating patients with DMD. The researchers used a two-round modified Delphi process to gather expert opinion on the scorecards. During the Delphi process, the physical therapists evaluated the scorecards for all 15 movement tasks. The movement tasks are activities that patients typically do at home, such as walking, climbing stairs, putting on a t-shirt, and eating. After two rounds of review and revisions, the expert panel confirmed that the compensatory movement criteria included in the DVA scorecards were understandable, comprehensive, and clinically meaningful.
“The DVA provides a window into the way patients with Duchenne move and function in their home environment,” said Marielle Contesse, “and our scorecards provide a standardized way for physical therapists to identify compensatory movement patterns. The at-home setting allows us to assess an even wider range of day-to-day movements. It also eliminates the need for patients and families to travel long distances to clinical trial sites.”
She added, “Ultimately, we hope that the DVA will be able to detect changes in patient function in a shorter period of time than existing outcome measures. This could potentially reduce the time that patients spend participating in a clinical trial.”
Emmes Chief Executive Officer Dr. Christine Dingivan noted, “This research provides the foundation for using Casimir’s Duchenne Video Assessment to widen opportunities for identifying disease progression and treatment options. We’re also encouraged by the potential use of the DVA to assess other muscular and mitochondrial diseases.”
About Casimir
Headquartered in Plymouth, Massachusetts, and founded in 2016, Casimir’s CRO services begin with the patient’s perspective, as the company takes new approaches to its clinical studies that help build a better understanding of rare disease progression and treatment. It prioritizes virtual trials and remote assessments, focuses on qualitative research that centers on the patient experience, and captures the real-world impact of treatment interventions on patient quality-of-life through smart outcome measures.
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 Acquires Casimir, Its Fourth Major Acquisition
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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 Casimir, a U.S.-based CRO. Casimir has experience in more than 20 rare diseases and has worked with regulators, sponsors and patients to develop outcome measures that capture the nuances of disease progression and treatment benefit.
Emmes Chief Executive Officer Dr. Christine Dingivan said, “This is the fourth acquisition for Emmes in just over a year, as we continue to add new biopharma clients and deepen our innovative research capabilities. The combination of Casimir and Emmes will further differentiate our global rare disease center of excellence, Orphan Reach™. We plan to continue and accelerate the groundbreaking work of Casimir in neurodegenerative and neuromuscular conditions with remote data capture and patient outcome standardization.”
Founded in 2016, Casimir is supporting 39 projects with 25 different clients. It is especially well known for its efforts in Duchenne Muscular Dystrophy (DMD) and the application of its proprietary Duchenne Video Assessment (DVA) tool that measures clinical outcomes via remote data capture. The DVA is actively being explored in a variety of other rare disease indications, as well as in other neurogenerative/neuromuscular diseases.
Rare disease research is a strategic priority for Emmes. The company established Orphan Reach™: Emmes’ Rare Disease Center to combine its expertise in biostatistics, data management and clinical research with Orphan Reach’s rare disease patient-centric focus. Now, with Casimir’s proprietary clinical outcomes technology, Emmes establishes itself as the industry-leading CRO in rare and orphan disease clinical research and drug development.
Casimir’s CEO and Co-Founder Christine McSherry said, “Emmes’ long history and passion to improve public health were instrumental in our decision to join this outstanding company. The size and reach of Emmes will give us an even greater ability to expand our current platform and outcomes development expertise to other neurodegenerative diseases and therapeutic areas.”
Rhonda Henry, President of Emmes’ BioPharma Group, noted, “The combination of Emmes and Casimir will provide our clients access to full-service protocol design, strategy and trial execution services, not only for rare diseases, such as DMD, but also for a variety of myopathies and neurological conditions.”
She added, “Casimir is known for its virtual clinical trials and remote assessments that minimize the burden on patients and caregivers. This is something that we will build upon in other Emmes studies, as our goal is to utilize more and more real-world evidence to improve data quality and information for doctors when treating their patients.”
According to Dr. Dingivan, “Another advantage of Casimir’s addition to our Emmes team is that its work with biopharma companies, patient advocacy groups, regulators, and non-profits to design and validate its tools, like video assessments, has broader application to rare disease studies for Emmes’ public sector clients, such as the National Institutes of Health.”
About Casimir
Headquartered in Plymouth, Massachusetts and founded in 2016, Casimir’s CRO services begin with the patient’s perspective, as the company takes new approaches to its clinical studies that help build a better understanding of rare disease progression and treatment. It prioritizes virtual trials and remote assessments, focuses on qualitative research that centers on the patient experience, and captures the real-world impact of treatment interventions on patient quality-of-life through smart outcome measures.
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 Transaction
Goodwin Procter served as legal counsel for Emmes. Covington Associates acted as exclusive financial advisor and Buckingham acted as legal advisor for Casimir.
Emmes Supports New Collaboration to Accelerate COVID-19 Research for Children
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Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02). The team, led by the Pediatric Trials Network at Duke University, also includes the Gabriella Miller Kids First Data Resource Center (DRC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
POP02 is one of several cohort studies within the Collaboration to Assess Risk and Identify LoNG-term outcomes for Children with COVID, known as CARING for Children with COVID. The National Institutes of Health (NIH) initiated the CARING for Children with COVID program to collect clinical data and samples that would advance the understanding of SARS-CoV-2 infections in children. The program seeks to provide information to help healthcare providers and parents make informed decisions when caring for children infected with either COVID-19 (acute coronavirus disease) or who have MIS-C (multisystem inflammatory syndrome).
Data from the POP02 study was used to develop and pilot tools leveraging the Health Level Seven International® (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard. These are new tools and resources that will advance and accelerate the rapid release and accessibility of pediatric COVID-19 clinical data.
The first batch of POP02 data (representing 57 participants) has been released using a newly launched FHIR Application Program Interface (API), in cooperation with the Kids First DRC. A second batch of data will be released in the coming weeks.
According to Emmes’ Vice President of Maternal and Child Health, Ravinder Anand, Ph.D., “The FHIR API is the first-of-its-kind implementation for near real-time, secure release of pediatric COVID-19 data. Before our partnership with Kids First DRC, Emmes had developed FHIR APIs across multiple cloud platforms to easily accommodate the addition of ongoing semantic information. The Kids First cooperative effort required mapping the data collected in the POP02 study case report forms to existing FHIR resources and incorporating additional terms from a variety of health sources, such as SNOMED Clinical Terms.”
Valerie Cotton, deputy director of the Office of Data Science and Sharing at NICHD, said, “Rapidly sharing pediatric COVID data using interoperability standards accelerates research that will help understand the impact of the pandemic on children and design interventions. This effort is a model for how groups can collaborate to respond to public health needs.”
Emmes’ work to support the POP02 and its participation in the CARING for Children with COVID project grew out of its existing role as the Data Coordinating Center for studies conducted under the Best Pharmaceuticals for Children Act (BPCA). Results from these clinical trials have contributed directly to improved drug labeling for a range of products used in treating infants and children.
“Our role as Data Coordination Center for the Best Pharmaceuticals for Children Act dates back to 2009,” noted Emmes Chief Executive Officer, Dr. Christine Dingivan. “Now, with this newer work, we’ve widened our focus from supporting the safe drug development in children to the international priority on how to combat pediatric COVID-19.”
About the Research
This project has been funded in whole or in part with Federal funds from the National Institutes of Health under Contract No. HHSN275201700002C.
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 Acquires Institut Dr. Schauerte, Entering Real World Evidence Market
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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 Institut Dr. Schauerte, a CRO headquartered in Munich, Germany. Founded in 1990, Institut Dr. Schauerte is a full-service, technology-oriented CRO that specializes in late-phase, non-interventional, and post-market clinical follow-up studies. It has conducted more than 400 studies across a range of therapeutic areas.
This is the third acquisition for Emmes in the last year, having previously purchased Neox, headquartered in the Czech Republic, in December 2020 and UK-based Orphan Reach in May 2021. The acquisition of Institut Dr. Schauerte augments Emmes’ global reach by expanding the company’s presence in Germany and adding new long-term strategic relationships with global biopharma companies. With Institut Dr. Schauerte, Emmes now has more than 1,200 employees.
Emmes Chief Executive Officer Dr. Christine Dingivan said, “This is another positive step in our growth and diversification strategy. Institut Dr. Schauerte has a 30-year history and deep expertise in the growing field of Real World Evidence (RWE) research. Its agile, technology-enabled approach is a perfect fit with Emmes and will enhance our digital capabilities.”
She added, “Emmes Europe is growing quickly, and Institut Dr. Schauerte will be joining an integrated team across the UK and EU that is successfully collaborating with colleagues in Canada, India and the U.S. to conduct global clinical trials.”
Institut Dr. Schauerte’s clinical trial operations have been conducted in more than 20 countries, and the company has seen accelerating revenues from post-approval non-interventional studies. RWE and Real World Data have become increasingly important in improving patient care and influencing product development and lifecycle management decisions for drug, device and diagnostic manufacturers.
Institut Dr. Schauerte also expands Emmes’ technology product line with its ClinDoc tool, a secure, intuitive CFR21 Part 11 compliant Electronic Data Capture (EDC) solution. It includes multi-language capabilities and interfaces for clinical trial management systems, electronic health records, and mobile health data from apps and wearables. ClinDoc complements Emmes’ Advantage e-Clinical EDC system, giving the company even greater flexibility to meet diverse customer needs.
Institut Dr. Schauerte CEO and Founder Dr. Wulfram Schauerte said, “Our deep expertise in RWE and a thriving set of offices in Munich and Cottbus, Germany, will be strong assets in Emmes’ global growth plans. We are excited about joining the company and working with our new colleagues in Emmes Europe. We share much in common; in addition to our dedication to high research standards, we place great value on employee engagement and long-term client relationships.”
Dr. Schauerte and Institut Dr. Schauerte’s leaders and staff will continue in their current roles.
“Emmes and Institut Dr. Schauerte have a combined legacy of over 70 years in business,” noted Dr. Dingivan. “Our team is looking forward to collaborating to improve the care and treatment of patients throughout the world, leveraging RWE to enhance studies ranging from Phase I to Phase IV, and using our EDC solutions to achieve greater data quality and efficiency for clients.”
About Institut Dr. Schauerte
Headquartered in Munich, Germany, and founded in 1990, Institut Dr. Schauerte is a technology-oriented full-service Clinical Research Organization that specializes in late-phase, non-interventional, and post-market clinical follow-up studies. Committed to providing high quality, bespoke RWE services and solutions, Institut Dr. Schauerte serves pharmaceutical and medical device companies across Europe in a broad range of 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
Emmes Announces Completion of Third ACTT Clinical Trial for COVID-19
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Emmes today announced that it conducted the data and statistical analysis for the third iteration of the Adaptive COVID-19 Treatment Trial (ACTT-3), using its proprietary Advantage eClinical system. The ACTT-3 trial assessed the efficacy and safety of interferon beta-1a plus remdesivir compared to remdesivir alone in hospitalized adults with COVID-19.
Preliminary data from prior small studies had suggested a potential benefit of interferon beta-1a, a natural antiviral component of the immune system, for COVID-19 patients. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored a randomized, double-blind, placebo-controlled clinical trial that included 969 participants at 63 hospitals in five countries, including the U.S. to evaluate the combination of interferon beta-1a and remdesivir.
The study concluded that the use of both Interferon beta-1a and remdesivir was not superior to remdesivir alone in patients hospitalized with COVID-based pneumonia. The results also indicated that the subgroup of participants receiving high-flow oxygen at randomization had worse outcomes after treatment with interferon beta-1a compared with those who received placebo.
Michelle Green, Dr. Mat Makowski and Jennifer Ferreira co-authored a report about the ACTT-3 study that was published online on October 18, 2021, in The Lancet Respiratory Medicine.
Green, an Emmes vice president and Emmes’ ACTT-3 project manager, said that about 10 percent of the Emmes workforce has participated in the ACTT studies.
“Working on this research to address the best ways to treat COVID-19 is a source of great pride for our company,” she said.
Emmes Chief Executive Officer Dr. Christine Dingivan said, “We have served as a Statistical and Data Coordinating Center for NIAID’s Division of Microbiology and Infectious Diseases for more than two decades. Our Emmes team looks forward to continuing as active contributors to building the body of knowledge on COVID-19 treatments and vaccines.”
About the Research
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 and 75N93021C00012.
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 and MedGenome Launch Genomics Strategic Partnership Focused on Advancing Rare Disease Research
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Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced a partnership with MedGenome aimed at accelerating breakthrough treatments, powered by human genomics, for rare disease patients.
“This is an exciting opportunity to partner with the leading genetic testing laboratory in India and South Asia to use our collective expertise to help bring faster and more innovative treatments to patients around the world who are suffering from rare diseases and desperately awaiting new therapies,” said Emmes Chief Executive Officer Dr. Christine Dingivan.
“The unmatched potential to build comprehensive and curated disease specific cohorts will leverage the power of large data sets to design smarter research protocols and to reduce the time it takes to identify rare disease patients for clinical trials. Ultimately, we hope this will result in more successful treatment outcomes.”
During its recognition of Rare Disease Day on March 5, 2021, the U.S. Food and Drug Administration noted, “Patients with rare diseases often have few or no treatment options. In 2020, we continued to see significant progress in the development of treatments for rare diseases, also known as orphan products.” In 2020, the FDA approved 32 novel drugs and biologics that had an orphan drug designation.
Traci Clemons, Ph.D., Emmes’ Chief Research Officer, explained that the two companies would collaborate to combine patients’ epidemiologic, phenotypic and genomic data into custom disease registries to enhance study design, support patient recruitment, and create standard control arms for advanced statistical models of treatment effect.
“There are so many rare diseases and, at the same time, a very small global pool of potential patients for these clinical trials,” she said. “Creating these disease registries across high population regions will give us an even greater opportunity to identify and recruit patients with these very rare diseases into clinical trials. These cohorts will, in a sense, offer a customized data resource for potential research sponsors, from biotech firms to large pharmaceutical companies and government research institutions.”
Earlier this month, Emmes launched a new rare disease center, blending its expertise in biostatistics, data management and clinical research with Orphan Reach’s rare disease patient and clinical trial experience. Emmes acquired the UK-based Orphan Reach in May.
According to a recent article in Scientific American, “Only 5% of the 7,000 known rare diseases have an approved treatment, making patients with rare diseases collectively one of the most underserved communities in medicine today.”
Some of the initial rare diseases that the Emmes/MedGenome partnership will address include hemophilia, Duchenne muscular dystrophy and muscular atrophies, and retinitis pigmentosa.
MedGenome Services CEO Dr. Vedam Ramprasad, said, “Few people realize that India and South Asia have the world’s largest population of people affected by rare and inherited disease. Given the high unmet need of these patients and families, we are dedicated to expanding support and opportunities for the rare disease community in South Asia to contribute to, and benefit from, the substantial treatment advances being made in rare disease globally.”
He added, “Rare disease clinical trials face substantial recruitment and regulatory challenges globally. Our rare disease alliance with Emmes is positioned to directly mitigate these challenges and is a natural extension of MedGenome’s substantial investment to support rare disease patients and clinicians in South Asia.”
Dr. Christine Dingivan concluded, “There is no clear CRO market leader in this space. Our acquisition of Orphan Reach, the creation of our new rare disease center, and now this strategic partnership with MedGenome, solidifies our leadership standing in rare disease drug development.”
About MedGenome
MedGenome is a genomics-driven research and diagnostics company with a mission to expand access to personalized medicine in South Asia and other emerging markets and help improve global health. Its unique access to genomics data matched with clinical and phenotypic data provides insights into rare and complex diseases at the genetic and molecular level to facilitate research advances and personalized healthcare. MedGenome is the market leader for genetic diagnostic testing in India. For more information, go to: https://research.medgenome.com/
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 launches Orphan Reach™: Emmes’ Rare Disease Center
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The new global Rare Disease center of Emmes expects accelerating growth from US and European biotechs.
Emmes – a full service, global clinical research organization (CRO) – is launching its new center, Orphan Reach™ as a unique ‘rare CRO’.
The new rare disease center will incorporate Emmes’ world class reputation in public health research across the public sector and biopharmaceutical industry, with the expertise of Orphan Reach, a UK-based specialty CRO acquired by Emmes in May 2021. The addition of Emmes’ renowned biostatistics, data management, and global clinical trial execution capabilities will enable the center to function as a full, end to end services organization.
The expanded Orphan Reach is a global specialty center dedicated to the advancement of rare disease research by providing specialized clinical trial design and execution capabilities. It is expected that the Orphan Reach clinical study portfolio will double over the next 12 months, with Emmes’ joint services and technologies bringing new capabilities to the expanding rare disease drug development market.
Emmes Chief Research Officer, Traci Clemons, PhD sees the new combined organization as stronger together, adding: “Collectively, we have an incredibly strong team, bringing together deep global rare disease clinical operations capabilities with extensive scientific research experience across multiple rare disease indications. In areas such as ophthalmology, metabolic disorders, and gene therapies, Emmes has data and analytical origins spanning over four decades and a wealth of scientific publications.”
The newly dedicated center will be launched at the World Orphan Drug Congress in Barcelona, Spain on November 15th. In addition to Dr. Clemons, the center will be led by a team of senior industry executive experts in rare diseases including Thomas Ogorka, Managing Director, and Nazira Maruf, Vice President of Project Management.
Thomas Ogorka commented: “Our passion for the services we provide and the dedication we have to the patients in our trials has always been of paramount importance to Orphan Reach, and a contributing factor to our successful long-term collaborations with clients. We are excited to increase our impact within the rare disease space, especially as we broaden and deepen our service offerings through the new Emmes rare disease center. We are nimble, responsive and proactive in ensuring trials can advance more quickly through what are nearly always accelerated pathways.”
With more than 7,000 known rare diseases, biopharma customers often struggle to identify the right development partner – one who understands the unique aspects of rare disease clinical trials and can build a customized operational strategy aimed at reaching rare patients globally. Emmes’ Orphan Reach rare disease center has demonstrated success in this area and is able to leverage highly experienced global networks and resources in addition to dedicated team members in offices across Canada, US, Europe and India.
On the reasons behind the formation of the new dedicated center, Dr. Christine Dingivan, Chief Executive Officer of Emmes added:
“We want to make it easier for both rare disease focused biopharma companies and public sector research institutions to accelerate development of new treatment options for rare disease patients by leveraging a highly specialized global CRO committed to rare disease clinical research. By harnessing the invaluable experience of the combined organization in over fifty rare disease indications, we will provide greater value to patients, investigators, and clients.”
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 or www.orphan-reach.com.
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