Navigation Links
Clinical Research Management gets contract for trials of therapeutics against infectious diseases
Date:8/7/2008

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
george.stamatis@UHhospitals.org
216-844-3667
University Hospitals of Cleveland
Source:Eurekalert

Related medicine news :

1. The Journal of Allergy and Clinical Immunology devotes special issue to AIDS
2. Escalon(R) Receives FDA 510(k) Clearance to Market the LIASYS(TM) Clinical Chemistry and Immunoturbidimetric Analyzer
3. Magellan Biosciences Companies to Feature Diagnostic Products Designed to Improve Health Outcomes at the Clinical Lab Expo
4. Hospital Clínic participates in ICREL project about European legislation on clinical trials
5. Clinical Trial Concluded For New Wrinkle Treatment
6. Clinical Trial for the Treatment of Inflammatory Bowel Disease Begins at Tel Aviv Sourasky Medical Center
7. Vertos Medical Inc. Presents Clinical Data of its MILD™ Procedure at the 5th Annual Innovative Techniques in Spine Surgery Conference in Los Cabos, Mexico
8. North Carolinas Center For Advanced Medicine & Clinical Research Celebrates Opening of New LKN Medical Spa and Rejuvenation Center
9. Brain cancer study: Magnitude of post-vaccine immune response linked to clinical outcomes
10. Northwestern Memorial Among Americas Best Hospitals in 10 Clinical Specialties According to U.S. News 2008 Rankings
11. Dr. Daniel Von Hoff Discusses "The Complete Phase Ib," A Clinical Trial Design Offering Faster Drug Development, Economies of Scale and Improved Therapeutic Benefit
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/6/2016)... ... , ... US Sports Camps has collaborated with State Rugby Organization (SRO), Rugby ... summer. Employing world-class rugby figures, including former Team USA players and college coaches, this ... fundamentals, match play, fitness and more. , “US Sports Camps is honored to be ...
(Date:5/6/2016)... ... 06, 2016 , ... Logically, spring weather, with its moderate humidity and temperatures, ... cold, dry or hot, water on the eye surface can evaporate, creating uncomfortable dry ... air. There’s only one problem, according to radio show and water advocate Sharon Kleyne: ...
(Date:5/6/2016)... York, NY (PRWEB) , ... May 06, 2016 , ... ... Hotel & Resort on the north end of the island close to the town ... July 17th- August 10th 2016. , “We continue to have an amazing experience ...
(Date:5/6/2016)... ... May 06, 2016 , ... ... of career-focused education and corporate training, and the National Military Family Association, a ... Maritza Aquino as the second full-tuition scholarship recipient of 2016. , “Being ...
(Date:5/5/2016)... (PRWEB) , ... May 05, 2016 , ... TransWipe Volume ... Cut Pro X. Drag and drop a TransWipe preset between two video clips to ... smooth corner wipes to colored panels with customizable color and orientation options. TransWipe Volume ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... 3, 2016 BioNovus Innovations LLC and ... Advancing Medical Innovation (IAMI) today announced a new ... and medical devices. An agreement between ... to license, develop and commercialize medical innovations advanced ... "This partnership represents a significant advance in our ...
(Date:5/3/2016)...  As a teenager, an active and athletic ... his heart. He continued enjoying sports and recreation throughout ... heart was giving out and he was a few ... the Mesa, Arizona resident received ... heart transplant, the SynCardia TAH-t is the only approved ...
(Date:5/3/2016)... ORANGE COUNTY, Calif. , May 3, 2016  While you may be familiar with watching ... 4K resolution , also known as ultra-high-definition or 8MP in the Medical Industry.  Ampronix  is ... class manufacturer of innovative technology. Photo - http://photos.prnewswire.com/prnh/20160502/362730 ... ... ...
Breaking Medicine Technology: