By Ms. Kristy Pottol and Mr. John Getz

Our Tissue Injury and Regenerative Medicine Program Management Office is tasked with a nearly impossible acquisition mission: to restore form, function and appearance to the wounded Warfighter post-catastrophic injury. The development costs are high, the programs are risky, the timelines are long, the commercial market is small and an enterprise-wide requirement is, to say the least, challenging to write. For our team, this is where innovation, opportunity and possibility thrive. Our Service Members are counting on us to be as innovative in our problem-solving battle as they are on the front lines, protecting and defending our freedoms.

The U.S. Army Medical Materiel Development Activity has a unique role in the Army acquisition space. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters. These products include drugs, vaccines, biologics, devices and medical support equipment intended to promote readiness and maximize survival of casualties on the battlefield. However, USAMMDA’s TIRM PMO also works diligently to support our Service Members returning from the fight; many of whom are scarred both physically and mentally following catastrophic combat injuries.

The TIRM PMO looks to amplify the Department of Defense’s Manufacturing Innovation Institute (now branded as Manufacturing USA) investment by utilizing a “whole-of-government” approach as a force multiplier and tapping into the recent successes found within the exciting field of regenerative medicine. Our commitment to cross-coordination among non-Department of Defense government agencies has led to an identification of key barriers in regenerative medicine solutions that currently exist across the nation. This problem list was briefed at the National Science and Technology Council Subcommittee on Advanced Manufacturing in September 2015, on behalf of all agencies funding regenerative medicine. This focused coordination of the industrialization challenges became the catalyst for the newly established DOD Manufacturing Innovation Institute for regenerative medicine.

Only 15 months after the aforementioned briefing, the DOD announced $80 million in funding for the award of their first biomanufacturing effort under the Manufacturing USA program, with an additional $214 million pledged by industry partners. This award was completed and presented to the Advanced Regenerative Manufacturing Institute in Manchester, New Hampshire, to establish, through a public–private partnership, the BioFabUSA institute. This critical endeavor bridges the gap between early scientific research and later-stage product development by strategically advancing critical technologies to enable large-scale tissue product manufacturing efforts. Addressing manufacturing challenges early in the acquisition lifecycle reduces risk, thereby enabling accelerated development of new producible, sustainable and affordable technologies in this rapidly evolving area.

The whole-of-government approach continues to be a key success factor for the regenerative medicine field and for BioFabUSA. Representatives from all Armed Services and across all relevant government agencies, with expertise in some element of manufacturing and testing technologies, are included in the BioFabUSA technical working groups. We have assembled a voluntary intra-government Biomanufacturing Stakeholder’s Council to share lessons, successes, vision, goals and networking contacts, so that we can solve difficult problems by working to our collective strengths.

Key leadership from USAMMDA’s TIRM PMO is proud to champion this groundbreaking venture. While the focus of BioFabUSA is placed on the manufacturing and testing barriers for tissue engineering, having the oversight of this program embedded within the TIRM PMO ensures alignment with our acquisition programs and helps to leverage value propositions with our industry partners. The BioFabUSA business model mixed with the TIRM PMO’s development pipeline ensures that we mitigate development risk, increase opportunities for cost control, and provide thought-leadership in this emerging, regulated landscape. This strategic alignment will inevitably accelerate numerous medical products for treating our wounded Warfighters, which will contribute to Army readiness and save lives on the battlefield of the future.

The DOD’s $80M investment in this nascent field has catalyzed a public–private partnership that aims to upend traditional processes for biopharmaceutical development. Innovative public–private partnerships leverage the creativity of the free market and advance DOD objectives. ARMI has carefully selected trust agents via a Board of Directors with long track records of creating products that have positively impacted the world. The seemingly impossible challenge of developing tissue products on an industrial scale while also supporting the needs of our Service Members creates an unprecedented partnership. We fully expect that silos and stovepipes can and will be eliminated in the interest of advancing technologies to bring solutions to our wounded Warfighters.

The implementation of BioFabUSA is aimed to bring together an emerging and fragmented industry with targeted academic research to create a stable and growing tissue engineering industry that will literally change medicine and support Army’s challenging medical acquisition programs. To accomplish this, the main thrust of BioFabUSA’s diverse membership is focused on eliminating industrial manufacturing technology barriers through problem-solving centered on teaming and the creation of an “industrial commons” workspace. We expect to help promising new products reach the marketplace through a unification of knowledge, materials and equipment that may be shared between large and small organizations — quite revolutionary considering the possibilities that lie ahead.

One of our primary goals is to find novel ways to acquire the necessary products to treat our Service Members and provide the products they need, when they need them, and this program will certainly help to accelerate the delivery of these critical products to the Warfighter. We must be ready, so they can be ready, not only on the battlespace, but when returning home with profound injuries. As part of our mission, the TIRM PMO is called upon to provide the necessary elements and treatments to restore form and function to our severely injured men and women. Therefore, we must seek out ways to source these products, and we are excited about the tremendous potential of the BioFabUSA institute in helping to streamline the process of creating the end products we need.

BioFabUSA is focused on bringing together industry, academia and government to work on problems that are more difficult than any one institution alone can solve — it’s about encouraging partnerships to create our essential products and to fill critical medical gaps for Service Members. Through this innovative new BioFabUSA endeavor, we undoubtedly will accomplish significantly more, and in a much faster timeframe, by working together rather than competing against each other — it is a win-win situation for everyone.

Ms. Kristy Pottol is project manager of the Tissue Injury and Regenerative Medicine Project Management Office of the U.S. Army Medical Materiel Development Activity, Fort Detrick, Maryland, and also serves as the program manager for the Department of Defense BioFabUSA Institute effort. Ms. Pottol is a certified Defense Acquisition Professional, Program Management Level III, and a member of the Acquisition Corps. She holds a Master of Business Administration degree from Regis University, a Master of Science degree in accounting with emphasis on Information Systems from the University of North Carolina at Wilmington, and a Bachelor of Science degree in physics with an emphasis in biophysics from East Carolina University.

Mr. John Getz is a product manager in the Tissue Injury and Regenerative Medicine Project Management Office of the U.S. Army Medical Materiel Development Activity, Fort Detrick, Maryland. He also serves as deputy program manager for the Department of Defense BioFabUSA Institute effort. Mr. Getz is a certified Defense Acquisition Professional, Program Management Level II. He holds a Bachelor of Science degree in biology with emphasis in chemistry from Millersville University of Pennsylvania.


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