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A public-private partnership
BALTIMORE, Md.—Paragon Bioservices Inc. and the Center for Stem Cell Biology and Regenerative Medicine at the University of Maryland-Baltimore (UMB) have formed a public-private partnership for developing and manufacturing stem-cell therapies. The consortium also will include California-based Life Technologies Inc., which will provide training for research scientists who perform work for the partnership.
"The main objective of the consortium is to accelerate the development of novel strategies for regenerative medicine, including new treatments and preventatives derived from stem-cell research," says Dr. Curt I. Civin, director of UMB's Center for Stem Cell Biology and Regenerative Medicine.
The center will collaborate with Paragon, a contract research and GMP manufacturing organization, to establish a core facility that will offer stem cell services on a fee-for-service basis. The services offered include cell banking and production of a variety of stem cell types. Stem cells will be available for research purposes and eventually for clinical use.
The consortium will be headquartered at Paragon in the UMB BioPark and supported by core facilities at UMB. The consortium is being funded in part by a $200,000 Translational Research Award from the Maryland Biotechnology Center.
"The Maryland Biotechnology Center evaluated 60 proposals, and the consortium effectively competed for its award since it is dedicated to crossing the translational medicine divide, creating a model for sustainability and increasing the likelihood of commercialization of new technologies," explains Dr. Judy Britz, the MBC's executive director.
According to Aaron Heifetz, Paragon's head of business development and stem cell and regenerative medicine, in addition to the primary focus of the partnership, other goals of the consortium are to "establish a critical mass of stem cell expertise in Maryland to support robust academic and industrial use of stem cell technologies for therapeutic and drug development, ease translation of lab-based stem cell research into clinical and commercial use and provide service and support for stem cell-based technologies."
The transition to move the consortium forward will be simplified by the fact that much of the infrastructure and expertise is already present at Paragon, according to James Goolsby, a research and development scientist there.
"Funding is in place to expand Paragon's capacity within its existing space and is equipping it to support a variety of projects over the next three to four months," Goolsby adds. "The most active areas of research handled by the consortium are MSC production for preclinical and clinical trials and IPSC production for research."
Goolsby notes that the consortium will offer participants access to a network of stem cell researchers for intellectual support.
"The facility will not take an I.P. position on technologies developed," he says. "These facilities include preclinical production, process development laboratories and GMP facilities, with quality systems supporting compliance with GMP and regulatory guidelines. The facility will provide required facility-related documentation to support IND submission."
Talks are underway with other companies and institutions to join the consortium. As a partnership for better public health, the consortium is also openly seeking wider participation from other research institutions, state and federal agencies and private companies.
"The partnership will be successful as it facilitates the communication among public organizations and private companies that will encourage joint projects to develop new medical treatments," Goolsby says. "The ultimate success would be to have a stem cell product see the light of day as a tool for drug development or therapeutic use."