A joint venture between the Medical Center and a California biotechnology company may bring the City of Medicine to the forefront of clinical treatments in the 21st century.
Last month, officials at the Medical Center and ExVivo Therapies, Inc. announced plans to construct a cell processing center designed to grow and modify human cells for therapeutic purposes.
The 20,000-square foot ExVT Center at Duke will be built near Durham Regional Hospital and will be operated by about 40 employees, officials said.
The site will serve as the first cell processing center on the East Coast and marks the first such collaboration between industry and an academic center.
"We believe this cooperative facility exemplifies the crucial partnerships between universities and corporations that must be established to facilitate rapid application of research to treatment of human disease," said Dr. Ralph Snyderman, chancellor for health affairs and dean of the School of Medicine.
Cell therapy is based on multiplying and modifying living cells with drugs, which are then reintroduced into a patient's body. The center will also focus on gene therapy, which seeks to restore proper cell function through genetic manipulation and reintroduction into the body.
While the high-tech therapies may sound like something out of a sci-fi movie all clinical trials must be approved by the Food and Drug Administration and a recombinant advisory committee in Washington, D.C.
Public fears may also be tempered by the fact that "the initial focus for therapies like this are serious diseases [such as AIDS and cancer], and the patients will have failed to respond to more conventional therapies," said Bob Taber, director of the University's Office of Science and Technology.
In addition, federal guidelines for cell and gene therapy development are extremely strict. Manufacturers must keep thorough records on all products and procedures, "so you can always trace back where a mistake was made," Taber said. This makes the manufacture of these molecular therapeutics extremely cost-prohibitive for a university, he added.
"This is not a trivial thing when you're putting a retrovirus into a human being," Snyderman said. "The collaboration with ExVivo will assure that the manufactured therapy will be the best it possibly can be."
ExVivo's expertise in cell processing is something the University lacked, Taber said. ExVT operates two cell processing facilities in California and is constructing a new center in Tokyo. The company is a joint venture between the California-based Applied Immune Sciences Inc. and pharmaceutical manufacturer Rhone-Poulenc Rorer.
ExVivo is building the $5 million facility and will give the University about 2,000 square feet of free space, Taber said.
While University researchers will benefit from ExVivo's support, the partnership gives ExVivo the rights and royalties to any therapies developed at the center by University scientists. These therapies will initially target AIDS and cancer of the breasts, ovaries and lungs.
"The expertise and quality controls offered by ExVivo Therapies will help us develop reliable clinical trials based on promising new genetic therapies under development at our medical center," Snyderman said.
Officials hope the center will encourage more companies to move to the Research Triangle Park. In the wake of workforce reductions at the Hospital during the past year, the ExVT center is expected to create new jobs in the Triangle area.
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