A new initiative at the Medical Center will provide academic and industry researchers the expertise and scientific collaboration necessary to conduct early stage clinical studies. The Center for Human Experimental Therapeutics represents the first university-based program focused on accelerating the development of novel medical therapies.
“This center consists of both infrastructure and a group of people with decades of combined experience in conducting experimental human therapeutics and running some of the more complex clinical studies in the world,” says neurologist Karl Kieburtz, the center’s director. “It is a unique approach that represents a marriage of scientific expertise and logistical competence, with a focus on the early stage of drug development.”
The center is designed to address a critical juncture in the process of developing new treatments, one that is probably the most significant and persistent barrier to progress in medical research: the initial translation of novel interventions from preclinical evaluation—research performed in the lab—into the first human clinical trials. This phase is often referred to as T1, meaning it represents the first stage of translating biomedical discoveries into new human treatments.
This phase of research is one that has become a high hurdle for scientists to overcome. The process of conducting initial human investigations has not traditionally been a focus of academic institutions. It’s also a function that is being outsourced by larger pharmaceutical and medical device companies that are increasingly dedicating their resources to later stage clinical studies as opposed to newer approaches that may have a higher risk of failure.
Consequently, many of the truly novel approaches to treat disease being developed in a university setting or by smaller biotechnology companies often fail to advance to the clinical stage. One of the functions of the center will be to assemble under one roof the resources needed by academic and industry scientists that are necessary to answer fundamental questions about their early stage research. These include whether or not the intervention is safe, tolerable, feasible, and targets the intended mechanism.
The center brings together resources at the Medical Center designed to assist in translational research. The Clinical Trials Coordination Center and the Clinical Materials Services Unit will now operate under the direction of the new center. The new center will also coordinate closely with the activity of the Medical Center’s Clinical and Translational Science Institute.
The center and its staff will work in the new Clinical and Translational Sciences Building, which is scheduled to open in March 2011.
More information can be found at www.urmc.rochester.edu/chet.