PROGRAMS

Industry Magnet Program Office

Medical science is not useful to society unless it is configured in a manner that can be effectively used clinically. New medical science also needs to be validated for each specific clinical application.  In certain cases, the time for clinical assessment and validation equals or exceeds the time to develop the science, and in many cases, the cost of the clinical assessment and/or validation exceeds the research and development phase, hence timely translation is an essential ingredient in the movement of medical science from the bench to the bedside.

The overarching goal of the Industry Magnet Program is to forge a uniquely transformative, innovative, and integrative academic and industrial home for translational science that has the collective resources to: 1) captivate, advance, and nurture a cadre of well-trained multi- and inter-disciplinary investigators and research teams; 2) create an incubator for innovative research tools and technologies; 3) synergize multi-disciplinary and inter-disciplinary clinical and translational research and researchers to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care.  

The program will combine recruitment of entrepreneurial research programs, establishment of core facilities, and fusion with the interests of global companies in order to position the McGowan Institute as the ideal partner through which these companies can explore, participate in, and then manufacture regenerative medicine products.

Specifically, the objectives of the Magnet Program are to:  

• Recruit world-class leaders in the field of regenerative and rehabilitation medicine to the McGowan Institute for Regenerative Medicine
• Establish new collaborative research and development programs with global pharmaceutical and  medical device companies
• Establish the McGowan Institute as a global leader in pre-clinical model development for regenerative medicine
• Establish a core facility for combinatorial screening of cell-material interactions
• Establish a recognized expertise base in regulatory affairs in regenerative medicine
• Identify new drug technology such as small molecule drugs that can be used as safety switches regulating the behavior of transplanted cells
• Provide a business model that is similar to current Pharma approaches
• Establish the nation’s first center of excellence in the study of health economics for regenerative medicine

Regulatory Affairs Program Office

Regulatory Affairs is a vital activity within the Institute that drives the research and development efforts of the organization to translate research successfully. The McGowan Institute’s Regulatory Affairs Program Office will be a dynamic business endeavor which works with the focus of providing technologies to the patient with the least possible time and expenses.

Regulatory Affairs will be the primary liaison to the FDA responsible for directing, planning, and implementing regulatory activities for Institute sponsored research.

The Office will provide valuable services including:

Regulatory Strategy Development

Provide support to faculty and staff for technology development in the transition from the discovery/preclinical stage through regulatory (FDA or EPA) approval for Institute sponsored products and to provide consultative support for non-Institute-sponsored products.

Regulatory Submissions

Implement industry best practices for the preparation of regulatory documents and their submission to the FDA.

Document Control

Serve to establish and maintain an official and complete repository of sponsor’s regulatory files for research conducted under Institute sponsored 510(k)s, investigational and approved drugs, vaccines, biologics, diagnostics, and devices.

Safety Reporting

Back to Top

Print This Section