TIRM PMO Leads Groundbreaking Initiative in Regenerative Medicine Industrialization
In June 2016, the Department of Defense announced a new initiative that may change the landscape of tissue regeneration. As the first biomanufacturing effort under the national Manufacturing USA program, the Advanced Tissue Biofabrication Manufacturing Innovation Institute will address the challenges facing novel biotechnologies during scale-up for commercial use. After a rigorous selection process involving numerous highly qualified competitors, the White House announced the recipient in December, with the award going to the Advanced Regenerative Manufacturing Institute, Inc., Manchester, New Hampshire. ARMI will now receive $80 million in federal funding, while a consortium of more than 85 partners from across academia, industry and government will add approximately $214M in private commitments.
The focus of this endeavor is to bridge the gap between early scientific research and later-stage product development by advancing critical technologies to enable large-scale biological manufacturing efforts. Helping to guide this venture is Kristy Pottol, project manager of the U.S. Army Medical Materiel Development Activity's Tissue Injury and Regenerative Medicine Project Management Office, Fort Detrick, Maryland. Pottol believes that regenerative medicine and tissue engineering products are likely to be the biggest beneficiaries of these advances.
"We have an amazing opportunity with this project, which could turn out to be revolutionary in the development of tissue engineered products," said Pottol.
"This effort was announced at the White House Organ Summit last June," she continued, "because many believe that solving the problem of tissue regeneration could lead to solving the problems related to much-needed organs for saving lives – so we have a multistep, multiyear goal in place that starts by solving the tissue engineering problem first."
The DOD's interest in biomanufacturing has spawned from the challenges of restoring Service Members to form, function and appearance following catastrophic combat injuries. As conventional approaches may sometimes fall short of full restoration, USAMMDA's TIRM PMO has overseen numerous research projects focused on developing novel solutions to address this need. Currently, the most successful projects in the TIRM PMO's portfolio are efforts in the field of Vascularized Composite Allotransplantation, which involve hand and face transplants, and the ongoing development of a skin substitute to treat burn wounds.
In light of this, success remains paramount throughout this endeavor – for the benefit of both military and civilian patients going forward.
It is now ARMI's task to solve the manufacturing challenges that hinder the development and production of new bioengineered tissue and organs, but this mission will certainly be bolstered by ARMI chairman Dean Kamen. As chief executive officer of DEKA Research and Development Corporation, Kamen is a leading scientist and inventor known for creating numerous successful products including the LUKE prosthetic arm and the Segway PT electric transporter.
Kamen will bring together thought-leaders from a wide variety of disciplines – from cell biology and bioengineering to computer modeling and materials science – to develop critical techniques that may unlock the doors leading to engineered tissue constructs. Pottol said these "collaborators" will create an "industrial commons" that may be shared by everyone going forward, providing open access to a wide spectrum of scientific knowledge.
"These collaborators understand the need to support common problem-solving projects for the advancement of the field rather than for the benefit of a single institution," explained Pottol.
"They will have access to technology across the membership, access to an open industrial commons, and will see the best and brightest researchers and industrialists working together – which could produce great scientific synergies that may lift an emerging field of medicine."
ARMI hopes to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones.
When asked to elaborate on the potential of tissue regeneration in relation to this project, Pottol's eyes grew large, as she was visibly excited by the future prospects.
"This particular moment in history may prove very significant for advancements in this field," she said. "We have the opportunity to be part of the beginning of revolutionizing bioengineered tissues and organs, which may change the way we think about medicine and healthcare solutions.
"The ultimate goal might be far in the future," she continued, "but when you read the history books, this is the moment where government, industry and academia came together as game changers. We're very excited to be involved in this project and the promise of healing our wounded Warfighters."
John Getz, TIRM PMO product manager and ATB-MII deputy director, is equally excited about the potential of this critical project.
Said Getz, "How this acceleration path may occur [for tissue regeneration] is unknown; it could be 30 years, or perhaps 10 years if some magic breakthrough happens through all of the innovation centered around this space.
"But technological breakthroughs do happen more quickly today," he continued. "It's the 'unknown' unknown, the unexpected discovery, which could make this field incredibly vibrant!"
Recently, ARMI and government project leadership held its initial technology working group session at the National Museum of Health and Medicine in Silver Spring, Maryland. The group included representatives from ARMI, University of Florida, Georgia Institute of Technology, Merck, National Institutes of Health, National Institute of Standards and Technology and other organizations.
Pottol said the meeting began with an extensive behind-the-scenes tour, so that attendees could place the ATB-MII effort within the context of military medical innovation. Participants viewed firsthand various items related to tissue biofabrication, and the advancement of tissue-related treatment throughout the history of military medicine.
"It was an amazing experience that was very well received by all," said Pottol, "and some were quite moved by what they witnessed. I believe everyone was grateful for the opportunity to see this new DOD-led effort placed into a realistic context.
"The museum setting helped to tell the story to a public-private partnership in a way very unlike a typical PowerPoint presentation," she continued. "They saw and touched artifacts, and heard stories of real patients linked to an authentic history of this effort – they saw the real cost of our freedom."
Pottol said she has been asked to speak at the National Academy of Medicine's Forum on Regenerative Medicine this June, and she is looking forward to the opportunity to convey the mission of ARMI and the ATB-MII.
"At that time, we plan to share our sense of where the field is and where it's headed, as well as the scope of our initial project efforts," explained Pottol, "and we are also excited to engage new potential members.
"Solving the challenges of industrializing tissue engineering will take diversity of thought from across many disciplines of science and technology. We need to bring these voices together."
Clearly, ARMI has much work to accomplish over the next five years, but the potential is immense and the prospects are exciting. In working with their extensive list of partners along the way, it is likely that many good things will come from such a synergistic collaboration. The road ahead offers the promise of restoring wounded Service Members and civilians to form, function and appearance – and the possibilities remain endless.