Manufacturing road map for tissue engineering and regenerative medicine technologies

The Regenerative Medicine Foundation Annual Conference held on May 6 and 7, 2014, had a vision of assisting with translating tissue engineering and regenerative medicine (TERM)-based technologies closer to the clinic. This vision was achieved by assembling leaders in the field to cover critical areas. Some of these critical areas included regulatory pathways for regenerativemedicine therapies, strategic partnerships, coordination of resources, developing standards for the field, government support, priorities for industry, biobanking, and newtechnologies. The final day of this conference featured focused sessions on manufacturing, during which expert speakers were invited from industry, government, and academia. The speakers identified and accessed roadblocks plaguing the field where improvements in advanced manufacturing offeredmany solutions. Themanufacturing sessions included (a) product development toward commercialization in regenerativemedicine, (b) process challenges to scale upmanufacturing in regenerativemedicine, and (c) infrastructure needs formanufacturing in regenerativemedicine. Subsequent to this, industrywas invited to participate in a survey to further elucidate the challenges to translation and scale-up. This perspective article will cover the lessons learned fromthesemanufacturing sessions and early results fromthe survey.We also outline a road map for developing the manufacturing infrastructure, resources, standards, capabilities, education, training, and workforce development to realize the promise of TERM.