NEW YORK (GenomeWeb News) – Duke University Medical Center has opened a $5.3 million facility designed to apply systems biology and molecular medicine approaches to early-phase studies of new drug or medical device candidates, especially at the proof-of-concept or "first-in-human" clinical stages.
The new Duke Clinical Research Unit said it will work with other research centers, as well as drug and device makers, to apply 'omics and other advanced technologies in a variety of early-phase studies. That research, according to the DCRU, would include studies aimed at identifying and validating disease biomarkers, as well as studies into the biological processes involved in everyday activities, or behaviors linked to disease.
The DCRU is designed to carry out research studies by the roughly 800 faculty members within the Duke Clinical Research Institute, an academic clinical research.
"The unit is looking and working in over 20 different therapeutic areas now," John McHutchison, program director of the DCRU and associate director of the Duke Clinical research Institute, told GenomeWeb Daily News. "We have a lot of work in immunology. We have a lot of work in rheumatology, asthma and lung disease, hepatitis and liver disease, cardiovascular disease, diabetes, and metabolic diseases. And then in children, we're looking at a lot of different drugs that are given to children in different ways."
Among the unit's researchers, he added, will be Wesley Burke, chief of the medical center's division of pediatric allergy and immunology, and an expert in peanut and other food allergies in children. DCRU researchers can access the institute's technology cores in cell therapy, clinical vaccine unit, imaging, immune monitoring, and –omics technologies furnished by the Duke Institute for Genome Sciences & Policy, which is part of the university's Translational Medicine Institute.
The unit also includes a sample processing laboratory, and access to Duke core labs at the medical center and in Kannapolis, NC, at the North Carolina Research Campus. Near the campus, the DCRU plans eventually to store most of its samples at a 10-million-sample capacity, 40,000-square-foot biorepository recently developed by Laboratory Corporation of America, and operated by LabCorp in partnership with Duke's TMI.
Other DCRU resources will include an Echo magnetic resonance imaging system, informatics professionals, nurses trained in clinical research as well as patient care, a bionutrition division with metabolic kitchen and clinical nutrition services, a biostatistician, and a research subject advocate.
"If you know there's somewhere you can go where you will get something done, and it will be done efficiently and it will be cost-effective, and it won't take too long and you've got access to modern technologies or –omics or whatever it might be, you're much more likely to work with it and to be successful," McHutchison said in an interview Tuesday. "What we've tried to do with the DCRU is create a local infrastructure where investigators can explore a novel drug or a novel intervention or some biology in a very safe, user-friendly environment."
Catherine Lavin, the unit's director of operations, told GWDN that the DCRU will be staffed by 30 to 40 full-time equivalent employees, which will include a mix of core staff and other staff on an as-needed basis.
Duke funded the cost of building the DCRU facility and launching the unit — an expanded replacement for the General Clinical Research Center — as one of several expenses it agreed to shoulder in return for being designated one of 46 institutions within a national consortium to receive Clinical and Translational Science Awards from NIH. Duke's CSTA award, announced in 2006, called for the university to receive nearly $51 million over five years — a funding program for which Duke is expected to seek renewal in the 2011 federal fiscal year, which starts Oct. 1.
The CSTA consortium is designed to ultimately grow to 60 institutions, a goal NIH first said would take place in 2011, then 2012. Last July, in a Q&A on its web site, the NIH's National Center for Research Resources insisted the agency remains committed to the 60-institute goal, but did not tie that goal to a specific year.
Among the first studies under way at the DRCU is one designed to personalize aspirin therapies, ultimately enhancing its ability to prevent heart disease and stroke. The project is being funded through a two-year, roughly $1 million grant secured from the National Institute of General Medical Sciences through the $862 billion American Recovery and Reinvestment Act, according to the study's Principal Investigator, Geoff Ginsburg, founding director of the Institute for Genome Sciences & Policy's Center for Genomic Medicine.
"We've been using aspirin for, what, 100 years? Preliminary evidence and data suggest that there are certain people who are super-sensitive to it and certain people who are insensitive to it. Surely working that out is pretty important," McHutchison said.
The DCRU's 30,000 square feet includes a 17,000-square-foot, 30-bed unit for adults, as well as a 13,000-square-foot pediatric unit with six confinement beds and two infant family rooms.
Duke also hopes that the DCRU will be a resource that will help build relationships with industry partners. "We have examples that I'm not at liberty to talk to you about because of confidentiality [requirements]. We're exploring early treatment, early toxicity, trying to biologically understand what's going on," McHutchison said.
McHutchison said DCRU is one of only a few research centers nationally to enjoy easier access to disease-specific patient populations of children, adults, and senior citizens due to its location within DUMC, where he is a professor of medicine. The medical-center location also offers the clinical research unit immediate, round-the-clock access to an on-site, full-scale emergency response team.
"It's always safety-first when you're giving things to people in the stage of humans, in the stage of proof of concept early on. So you need to be doing that in a safe environment. The safest environment is a hospital," McHutchison said. "Would you rather receive a new drug in a hotel setting where you had to call 911 and the ambulance was five minutes away? Or would you rather do it in a hospital?"