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Description: Abstract:
The Texas A&M Institute for Preclinical Studies (TIPS) was created as a conduit through which new ideas in healthcare technology could be implemented and FDA approved. FDA certification of new drugs, devices, and therapies requires that all testing be performed according to FDA Good Laboratory Procedures (GLP). Without GLP protocols, even the most promising technologies will not pass FDA certification. Research performed at universities generates a tremendous number of good ideas that never reach the clinic because they are unable to overcome the barriers necessary for FDA approval. Similar barriers exist for small companies. By providing a framework under which testing protocols can be performed under GLP conditions, TIPS dramatically lowers the cost barriers for university researchers as well as small companies who wish to further develop their ideas and get them ready for an FDA application. In this presentation, we will discuss the origins, capabilities, and structure of TIPS and how it can achieve this goal.