McGowan Institute for Regenerative Medicine
The project is directed to the enhancement of quality systems in academic laboratories. While quality systems are an integral part of the manufacturing of medical products ranging from pharmaceuticals to medical devices, they are rarely used in the basic research that leads to the technologies that permit the products to be manufactured. The exception is that some academic laboratories that focus on clinical applications implement quality assurance (QA) systems principles that reflect and are compliant to regulations such as Good Clinical Practices, Good Manufacturing Practices and Good Laboratory Practices.
There is a growing recognition that for the early stage (basic) research there is a need for improved tools and guidance to facilitate the maintenance of the integrity and reproducibility of the data collected. The McGowan Institute has taken a lead role in the adaptation of Good Research Practices (GRP) by developing Quality Management Systems (QMS) “fit for the purpose.”
The focus of the project is to advance the maturation of quality systems at the McGowan Institute’s Center for Preclinical Studies and to institutionalize the most effective processes by working in conjunction with the Good Research Practice- Data Reproducibility Initiative (a cooperative venture amongst academic research labs across the Country) to develop processes and promote the advantages of adopting quality management systems in academic research environments. The GRP-DRI is a consortium of QA experts from six academic institutions (including the McGowan Institute) involved in biomedical research, are collaborating to develop quality system elements with the intention of making these elements accessible to all universities and their research scientists (free of charge) for integration into their research programs.
This work will result in an academic biomedical research lab at the McGowan Institute that will reaffirm and demonstrate the advantages of QMS for basic research, and, serve as a demonstration site (along with other Consortium member labs) to facilitate broad implementation of QMS.
To establish a national center of expertise in regenerative medicine focused on developing and delivering therapies that reestablish tissue and organ function impaired by disease, trauma or congenital abnormalities.
To foster the generation of scientific knowledge in regenerative medicine and to share that knowledge with researchers, clinicians and the public through educational activities, training and publications.
To educate and train scientists and engineers to pursue technologies related to regenerative medicine, and train a generation of clinicians in the implementation of regenerative therapies.
To support the commercialization of technologies in regenerative medicine and thereby accelerate the translation of research discoveries to clinical implementation and patient benefit.
The McGowan Institute, which is a partnership between the University of Pittsburgh and the UPMC Health System, was formed in 2001 to realize the vast potential of tissue engineering and other regenerative medicine-based techniques aimed at repairing damaged or diseased tissues and organs. The Institute serves as a single base of operations for the University of Pittsburgh’s leading scientists and clinical faculty working to develop tissue engineering, cellular therapies, and artificial and bio hybrid organ devices.
At the McGowan Institute the primary focus is on the development of technology to address tissue and organ insufficiency. The McGowan Institute is the most ambitious regenerative medicine program in the nation, coupling biology, clinical science and engineering. While there are certain select therapies based on regenerative medicine principles now in clinical use, much work lies ahead to realize the potential of this growing field. Advances in the underlying science, engineering strategies to harness this science, and successful commercial activities are all required to bring new therapies to patients.
McGowan-affiliated scientists’ efforts broadly cover:
- The replacement of tissue function with entirely synthetic constructs (such as in artificial organs), Functional restoration with constructs that comprise both synthetic and cellular components (such as in bio hybrid organs).
- The combination of temporary scaffolds with cellular components (such as in conventional tissue engineering).
- Cellular therapies, including those involving adult stem cells and genetically manipulated cells (such as for the repair of damaged tissue and muscle).
Today the Institute is comprised of ~230 affiliated faculty members whose primary academic appointments are in over30 different academic departments—these faculty members form a multidisciplinary team committed to the development and clinical implementation of regenerative medicine-based therapies.
The First Nonprofit Foundation has optimized the grant submission process by using a state-of-the-art, on-line application system. This streamlined system is easy for the applicant to use, and seems to offer efficiencies for the First Nonprofit Foundation review team as well.
It was a pleasure to meet with Joe Geiger and share with him our vision and needs in the development and implementation of a rapidly expanding regenerative medicine research and clinical translation program. His insight and appreciation of our strategies and challenges is sincerely appreciated.
Members of the Good Research Practice- Data Reproducibility Initiative met in March 2016 to address strategies to maximize Data Reproducibility & Rigor in Basic and Translational Research in Academia.
Consortia Members representing 6 Major US Institutions (left to right): Shawn Bengtson RQAP-GLP Quality Systems , University of Pittsburgh- McGowan Institute; Joan Adamo PhD, Director for Regulatory Support Services, University of Rochester ; Melissa Eitzen, MS, RQAP-GLP, Director of Regulatory Operations- University of Texas- Medical Branch, Galveston National Labs; Michael Jamieson DRSc, Director, Regulatory Support Services, University of Southern California,; Rebecca Davies, PhD, Director of Quality Central , University Of Minnesota College Of Veterinary Medicine; Catharine Bens, MS Quality Assurance , Research Integrity Compliance Manager, Colorado State University.