Clinical Research Management, Inc. has a proven track record in supporting clinical trials, most notably in its fifteen years of work with the U.S. Army's Phase I/II clinical testing center at the Walter Reed Army Institute of Research in Silver Spring, MD. CRM is the premier clinical research organization supporting this center. When CRM decided to expand its infectious disease capabilities, it looked to the National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID)'s initiative to utilize Phase I Clinical Trial Units for Therapeutics Against Infectious Disease.
"Partnering with experienced testing sites for new products against infectious disease fits our corporate focus and strategic expansion goals. We saw this as a prime opportunity to collaborate with our nation's prestigious infectious disease organizations," said Victoria Tifft, President of Clinical Research Management.
"Our corporate headquarters is in Northeast Ohio and our region hosts some of the finest researchers in the nation and we are committed to bringing a portion of our work to this area," Tifft said.
To achieve the goals of the contract, Clinical Research Management selected Case Western Reserve University School of Medicine and University Hospitals Case Medical Center (UHCMC) and Johns Hopkins University to serve as national safety testing centers for therapeutic agents developed for use against infections. Dr Mac Griffiss, a leader in infectious disease research, will serve as CRM Global Principal Investigator for this multi-center effort.
"Our commitment to growing the bioscience community in Northeast Ohio led us to Dr. Robert Salata at Case Western Reserve University and University Hospitals Case Medical Center. Dr. Salata and his team have significant expertise in infectious disease and Phase I clinical trials that suited the requirements of this contract perfectly. We've worked with the infectious disease researchers at Johns Hopkins University for many years. We knew that their expertise with early stage infectious disease would make JHU an ideal NIAID testing site for new drugs against infectious diseases," said Tifft.
Under the seven-year contract, each site will receive approximately $5.5 million to perform Phase I Clinical Trials for Therapeutics against Infectious Diseases. The units will assess the safety of investigational therapeutic products against viral (other than HIV), bacterial, parasitic and fungal infections, including biodefense pathogens, and emerging and re-emerging infectious diseases such as Severe Acute Respiratory Syndrome (SARS) and bird flu.
"This is a major award for Cleveland and a testament to the history and depth of experience we have in infectious diseases and clinical research," said Robert A. Salata, M.D., who will lead the new Phase I Unit for Case Western Reserve University and University Hospitals Case Medical Center.
"We continue to see emerging infections and resurgence of old infections. Drug discovery and testing of new compounds is critical in our fight against these new and old pathogens. This unit will allow first-in-human testing of new therapeutic agents for safety and tolerance," said Dr. Salata, who is chief of the Division of Infectious Diseases and HIV Medicine at UHCMC, and professor and executive vice chair of the Department of Medicine at Case Western Reserve University.
Phase I trials are the first stage of testing in humans. Normally, a group of about 20 to 80 healthy volunteers will be involved. These trials will be conducted in an inpatient clinic at UHCMC, where the subjects can be observed by full-time staff. Phase I trials also normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found.
The therapeutics will be tested in healthy volunteers, men and women 18 to 45 years old, drawn from the general population and including representatives of minority populations, according to the contract. Agents proven safe during Phase I trials can move forward for further testing.
The contract became effective in June, with the first study planned to begin in approximately six months.
|Contact: George Stamatis|
University Hospitals of Cleveland