The University of Minnesota was awarded the renewal of a contract to speed the development of cell-based therapies from the laboratory to clinical trials Thursday.
The University received a five-year contract totaling $8.6 million last week from the National Heart, Lung and Blood Institute to be one of five institutions in the Production Assistance for Cellular Therapies Program. The program’s mission is to speed the research and development of new treatments by providing assistance to researchers nationwide to get U.S. Food and Drug Administration study approval quicker.
John Wagner, principal investigator in the program and co-director of the Center for Translational Medicine, said the focus will be on two broad subjects: the study of immune cell populations, like natural killer cells that fight off diseases such as leukemia, and the advancement of stem cells.
Wagner said the two areas of focus in the program are areas of strength for the University. “They are the two areas for which we are the most known,” he said.
The University is not alone in its research efforts, however. It is one of five institutions, along with Baylor College of Medicine, Beckman Research Institute of the City of Hope, Harvard Medical School and the University of Wisconsin.
Wagner said all five institutions will work together for the ultimate goal of speeding up the process of putting their research into clinical trials — a process Wagner said takes many years.
“Not only do we have our own area of expertise, but we also have access to their new areas of development,” Wagner said. “That will be good for our institution and our state.”
The new contract is different from the previous one in that the focus will be limited to diseases of the heart, lungs and blood due to the program funding coming from the National Heart, Lung and Blood Institute, lab medicine and pathology professor David McKenna said.
McKenna said the funding may be the most important function of the contract.
“It is really designed to meet … funding need in the cost of cell therapies for clinical trials,” he said.
McKenna said the Molecular and Cellular Therapeutics Facility, where he is the medical director, is a major reason the University was selected to have their contract renewed.
“One of the specifics of the contract is a facility capable of creating clinical-grade cell therapies, and the Molecular and Cellular Therapeutics Facility is that,” he said.
McKenna said the facility follows the Current Good Manufacturing Practice (cGMP) regulations, which the FDA requires to develop a clinical product.
“It’s just a really controlled environment,” he said. “In a way, it is similar to a surgical suite in that it is an ultra clean facility.”
Wagner said the facility is one of the best university cGMP facilities in the country.
“It has 36,000 feet in lab space, which is large in comparison to any other university cGMP facility,” he said. “It has experienced technicians and administrators to make this work for making products for people.”
Robert Lindblad, chief medical officer of Production Assistance for Cellular Therapies, said there are other reasons they chose the University’s contract to be renewed.
“I have worked with the University for the last six years, and they have a great group of researchers and scientists that do really top-notch work,” Lindblad said.
The ultimate goal of the program is to see research move into clinical trials, and Wagner said this would happen at all phases of the five-year contract, depending on how far along the research is already.
“It is going to vary from project to project, depending on what we already know about it and how advanced the research is in the laboratory,” Wagner said.
McKenna said the University is unique in that they have the researchers to develop a good idea, they have the ability to translate that good idea into a clinical idea and then they have the ability to take that clinical idea and develop a clinical method for a production that is therapeutic.
“We kind of have the whole picture right here, and not a lot of other places do,” McKenna said.
Wagner said these abilities came from an investment by the University that led to the development of new therapies and moving them into patients.
“I think it is that history and this environment that has made us attractive to not only give us this one contract, but two,” Wagner said.