The impact will be significant locally as well, officials predict. Wake Forest and Rutgers will each receive $42.5 million over five years to fund their own research and research at partner organizations. Wake Forest University Health Sciences will build a new biomedical manufacturing facility at the Piedmont Triad Research Park to participate in the project. It will be located within the park's newest building, the Dean Biomedical Research Building, and will meet FDA standards for the production of human tissue materials generated by AFIRM. The university will hire staff and scientists for the project, but has not yet determined how many. The manufacturing facility, where the actual regeneration of tissue and bone will take place, should be online by the end of this year, officials said.
Five focus areas
Wake Forest's project team will be focusing on developing clinical therapies in five major areas over the next five years: burn repair, wound healing without scarring, craniofacial reconstruction, limb reconstruction or regeneration and "compartment syndrome," which is a condition related to inflammation after surgery or injury. Wake Forest researchers are already involved in a consortium of institutions with the U.S. Army Institute of Surgical Research on a number of related projects, and have already successfully grown muscle, bone and blood vessels in the lab with the aim of eventually melding them into more complex organs. Mark Van Dyke, the Wake Forest researcher who will coordinate project research in burn repair, said that while some of the applications being studied are further along than others, the goal for the military and the university is to move quickly.
"The programs are set up to be aggressive in their goals, so we'll have things working their way into human clinical trials as quickly as possible," Van Dyke said. He said the burn program should be ready for human trials within two years, and all five research areas should be in trials in the first five years of the program. George Christ, another researcher on the project focusing on skeletal muscle, said the long-range goal of the project is to literally regrow entire limbs, since in modern warfare many more soldiers are surviving major injuries thanks to improved body armor, but are then having to live with permanently broken bodies. "In the meantime we hope to be able to promote wound healing, functional skeletal muscles and restoring functionality on a cosmetic level, to improve the lives of these young kids who have been disabled," Christ said.
Future plans
The manufacturing facility will be relatively small at about 1,500 square feet and most likely be used exclusively by the AFIRM project, according to Piedmont Triad Research Park President Doug Edgeton. He said a budget for the construction of the lab has not been set yet, but meeting the FDA's "Good Manufacturing Practice" guidelines can be expensive, with estimates he's heard so far ranging widely from $500 to as much as $10,000 per square foot. This facility should be less expensive because the building is already there, but Edgeton said the park is hoping to be able to add additional biomedical manufacturing capacity in the future that could be accessed by other research park companies and used as a lure for new tenants. "That's something that would be a bit further down the line," Edgeton said, because the developer of such a facility would need to see more evidence of local demand before taking on such an expensive project. "If (AFIRM) outgrows this small facility quickly and has enough product going through there, that's something that would help us demonstrate that." Wake Forest officials said several state and federal legislators played important roles in securing the funding for the project, including U.S. Sen. Richard Burr, U.S. Rep. Virginia Foxx and state Sen. Linda Garrou. Garrou helped secure $12 million in state funding over two years for the Center for Regenerative Medicine, and Burr and Foxx spearheaded the effort in Washington to earmark $5.4 million from the Department of Defense and Department of Energy for the research. It will take more work to secure ongoing funding to keep the project running beyond its initial five years, but researcher Van Dyke said the most important priority is to move these promising regenerative technologies into the field as soon as possible. "We've been in a lot of meetings about this where we've seen photos of these battlefield injuries, and they're horrific -- it's not like anything you see in the movies or even in civilian traumas," Van Dyke said. "This is a tremendous responsibility we've been given, and it's one we take very seriously."
Reach Matt Evans at (336) 370-2916 or mlevans@bizjournals.com
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