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No seven-year itch for CRO
CHAPEL HILL, N.C.—Contract research organization Rho has been awarded a $158.3-million, seven-year, cooperative agreement—the largest federal contract in its 31-year history—slated to provide statistical and clinical coordinating services to the Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health.
The North Carolina-based CRO, which provides clinical research services for commercial and federal markets, will provide these services for DAIT’s large clinical research consortia in, predictably, the areas of asthma and allergic diseases, autoimmune diseases and transplantation.
“Rho is excited to be selected as DAIT’s Statistical and Clinical Coordinating Center to support the important work they are doing to help combat serious health concerns, such as asthma and allergies, autoimmune diseases and transplantation,” said Russ Helms, CEO of Rho. “Rho’s expertise and resources will help assure top-notch operational support, statistical analysis, clinical data management and bioinformatics services.”
Rho will use this money “in-house to support 89 clinical research studies in immune tolerance, asthma, atopic dermatitis, autoimmune diseases and organ transplantation,” according to Karen Kesler, senior statistical scientist and Leadership Group principle investigator (PI). All of the money supports work for these studies, including designing them, coordinating the research, gathering the data, ensuring the safety of the subjects and analyzing the results, she notes, adding, “Since this award is a continuation of ongoing research already being conducted by Rho, we are tasked with finishing many of the current studies as well as starting up more than 50 new studies. These studies will help researchers gain a better understanding of human immunology, immunologic diseases and new immune-based therapies.”
Five Rho employees are serving as PIs on this project: Kesler, as noted above; Dr. Ronald W. Helms, chairman and overall PI; Dr. Samuel Arbes, senior research scientist and group leader for the Asthma and Allergic Diseases Group; Dr. David Ikle, senior statistical scientist and group leader for the Transplantation Group; and Dr. Lynette Keyes-Elstein, senior statistical scientist and group leader for the Autoimmune Diseases Group. Additionally, day-to-day management will be provided by Michelle Walter, senior project director.
The project combines services that were previously under six separate awards from DAIT, five of which were held by Rho. This project has been funded with federal monies from NIAID under Grant No. UM2-AI117870.
In other NIAID news, the institute is launching a new study to better understand how adults develop respiratory syncytial virus (RSV), a virus that causes cold-like symptoms, in order to assist researchers in developing and testing future antivirals and vaccines to combat the virus.
RSV is the most common cause of lower respiratory tract infections—including pneumonia and bronchiolitis—among young children worldwide, according to the U.S. Centers for Disease Control and Prevention. In the United States each year, RSV leads to an average of about 55,000 hospitalizations among children younger than 5 years, with most of these hospitalizations involving infants younger than 6 months. Healthy adults infected with RSV tend to develop cold-like symptoms and recover without any problems, but the infection can cause severe disease in premature infants, children younger than two years with heart or lung problems, children and adults with weakened immune systems and the elderly. RSV infection causes roughly 14,000 deaths annually among U.S. adults older than 65 years.
“Challenge studies such as this are a unique way of enabling scientists to monitor, in a controlled setting, the natural history of a disease in exquisite detail, using the most powerful tools of molecular biology,” said NIAID Director Dr. Anthony S. Fauci. “By studying RSV infection in healthy adults, we hope to improve understanding of how this infection develops and determine the suitability of this particular strain of the virus for use in future RSV vaccine and treatment trials.”
Investigators will use a laboratory-developed strain of RSV called RSV A2, which is commonly used in research. The strain is the first molecularly cloned challenge virus, meaning the RSV A2 study virus originates from a single clone of the virus strain and has been tested to ensure it is not contaminated with other infection-causing pathogens.