Mary Clare McCorry


“ARMI BiofabUSA: Developing the Tissue Engineering Manufacturing Platform of the Future”


Mary Clare McCorry, Ph.D. is the Director for Technology and Process Development at the Advanced Regenerative Manufacturing Institute (ARMI). Prior to joining ARMI, she was an American Institute for Medical and Biological Engineering (AIMBE) Scholar at the U.S. Food and Drug Administration in the Center for Devices and Radiological Health (CDRH). As an AIMBE Scholar, she led science policy initiatives and coordinated collaborations between experts in academia, industry, government and non-profit organizations. Mary Clare joined FDA from Cornell University where she designed cell-based assays to study biomechanical/chemical MOA of cellular constructs, and consulted for industry on the design of specialized single use tissue bioreactors. Mary Clare received her PhD from Cornell University and her BS in Biomedical Engineering from Worcester Polytechnic Institute.


Over the last several decades, there has been enormous scientific progress in the field of tissue engineering. However, only a very small percentage of this scientific progress has translated into marketed tissue engineered medical products (TEMPs). The lack of TEMPs is largely attributed to the challenges of manufacturing therapies consistently, cost-effectively and at scale. The Advanced Regenerative Manufacturing Institute (ARMI), an industry-led public private partnership, was created to address these challenges through the DOD-funded BioFabUSA program. The institute has created a collaborative community that includes TEMP developers, manufacturing solution suppliers from commercial firms, and academia, who conduct interdisciplinary, advanced manufacturing R&D. This R&D activity aims to develop common, modular manufacturing platforms and associated processes, standards, and know-how to de-risk and lower the cost of developing and executing robust manufacturing for any TEMP product.