CSTAR offering medical testing grounds

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By Paul Mayne
Thursday, November 5, 2009
CSTAR, a branch of the London Health Sciences Centre and affiliated with The University of Western Ontario, has joined forces with Scarborough-based Nucro-Technics to provide pre-clinical research services to international companies in the biotechnology, pharmaceutical and medical device industries.
 
Research and testing is often a multi-stage process in which initial work provides guidance on whether to continue with a new product.
 
CSTAR (Canadian Surgical Technologies and Advanced Robotics) and Nucro-Technics will offer a full range of pre-clinical research services necessary to commercialize new drugs and medical devices.
 
This range covers the early stages of testing known as non-GLP (Good Laboratory Practice) proof-of-concept and efficacy studies, and latter-stage, GLP-compliant pre-clinical studies that enable companies to take their therapeutics to the clinic.
 
Demand for a 'one-stop shop' of research services is growing globally as companies realize the cost-savings and strategic advantages of outsourcing research and development activities, says CSTAR director John Parker.
 
The partnership opens the door to global biotech and medical device sectors having access to world-class laboratory facilities and expert personnel.
 
“This has the potential to raise the international profile of CSTAR, Western and the City of London as leaders in this field and provide meaningful opportunities in research, technology validation and education and training,” he says.
 
“The CSTAR/Nucro-Technics team solidly positions London and Ontario as leaders in enabling this critical first step in the development, validation and training for emergent medical technologies,” says Parker.
 
“In addition, the non-GLP proof-of-concept projects brought to London from around the world will provide substantial opportunities for establishing a recurring customer base to the benefit of CSTAR and its London-based partners, including Lawson Health Research Institute and The University of Western Ontario.”
 
Non-GLP research, or proof-of-concept research, is often the first step in developing new biotechnologies and medical devices, assessing whether a new idea should be explored further and under more rigorous conditions, such as in a GLP setting.
 
CSTAR will conduct studies with non-GLP requirements, while Nucro-Technics will conduct studies requiring GLP standards, which embodies internationally accepted standards for how lab studies involving primarily pharmaceutical chemicals are planned, performed, monitored, recorded, reported and archived.
 
GLP helps assure regulatory authorities, such as the Federal Drug Administration and Health Canada, that the data is a true reflection of the study results and can be relied upon when making risk/safety assessments.
 
CSTAR and Nucro-Technics, both members of the Ontario Ministry of Research and Innovation Business Development Team, have begun taking in customers and the first non-GLP proof-of-concept project is underway.
 
George Nikopoulos, a Health Sector MBA graduate of the Richard Ivey School of Business and Business Development Scientist at Nucro-Technics, says teaming up with CSTAR opens up new market segments for the company. 
 
“This partnership enables us to offer a complete pre-clinical research package,” says Nikopoulos. “In addition, CSTAR’s capacity to validate new medical device technologies and develop high quality training programs will prove extremely attractive to medical device companies as they look to develop their devices through to commercialization.” Nikopoulos sees the new relationship with CSTAR as a “unique and powerful opportunity” to facilitate the innovation and commercialization of therapeutics and medical devices.
 

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