TOM BOLLENBACH – ARMI

Biography:
Tom is a project manager at DEKA R&D Corp. and the Chief Technology Officer of ARMI. Prior to joining ARMI, Tom was Vice President for Research and Development at Harvard Apparatus Regenerative Technology (now Biostage), where he was responsible for the development and execution of IND-enabling preclinical and product development programs for implantable airway and esophageal constructs containing living cells. Before working at HART, he was Associate Director of Preclinical Research and Development at Organogenesis Inc., where he implemented and completed IND-enabling efficacy and preclinical pharmacology and toxicology programs for living, bioengineered skin grafts. Tom earned a PhD in Biochemistry at the University of Notre Dame.

BioFabUSA: A Collective Vision for the Future of Engineered Tissue Manufacturing

Tissue engineering promises to have a significant impact on modern surgery and transplantation medicine thanks to decades-long government investments in cell biology, materials science and biofabrication. However, technical and regulatory challenges and bottlenecks are limiting the large-scale manufacture of reproducible, quality-controlled tissues that will benefit patients. To overcome these challenges and alleviate bottlenecks, the field needs to develop and share broadly-applicable technologies, and manufacturing and regulatory knowhow. The Advanced Regenerative Manufacturing Institute (ARMI), a non-profit organization located in Manchester, New Hampshire, was awarded the Advanced Tissue Biofabrication Manufacturing Innovation Institute, now called BioFabUSA, by the Department of Defense on December 19, 2016. BioFabUSA will be sustained by a partnership of industry, academic, government and non-profit members, whose mission is to make practical the large-scale manufacture of engineered tissues and tissue-related technologies. To carry out this mission, the institute will integrate innovative cell and tissue culture methods with recent advances in biofabrication, automation, robotics, analytical technologies, computer science and modern process design and validation methods to create disruptive manufacturing tools and FDA-compliant volume manufacturing processes for all engineered tissue products. Bringing these products to the market will benefit critical U.S. public health needs and will provide the drivers needed to create a highly-skilled workforce.