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Dod Funds New Tissue Biofabrication Manufacturing Consortium

BIOFABRICATION sked REGULATORY INTELLIGENCE DATA BASE December 22, 2016 DEPARTMENT OF DEFENSE AGENCY GROUP 09 703-571-3343 INDSTRY GROUP 91 REGION GROUP 04 DOD FUNDS NEW TISSUE BIOFABRICATION MANUFACTURING CONSORTIUM CQ-Roll Call, Inc. 1255 22nd Street N.W. Washington, D.C. 20037 ...

BIOFABRICATION sked

REGULATORY INTELLIGENCE DATA BASE

December 22, 2016

DEPARTMENT OF DEFENSE

AGENCY GROUP 09

703-571-3343

INDSTRY GROUP 91

REGION GROUP 04

DOD FUNDS NEW TISSUE BIOFABRICATION MANUFACTURING CONSORTIUM

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WASHINGTON, Dec. 22, 2016 - The Defense Department will fund an 87-member coalition to develop next-generation manufacturing techniques for repairing and replacing cells, tissues and organs for wounded service members, the undersecretary of defense for acquisition, technology and logistics announced yesterday at the White House.

Frank Kendall introduced the winning consortium -- led by the nonprofit Advanced Regenerative Manufacturing Institute, headquartered in Manchester, New Hampshire, -- whose industry, academic and government members will be part of the new Advanced Tissue Biofabrication Manufacturing Innovation Institute, or ATB-MII.

The institute is the 12th manufacturing hub awarded by the Obama administration, seven of them so far led by DoD.

Manufacturing and National Security

"Manufacturing is deeply important to national security," Kendall said, noting that on Dec. 19 DoD signed a technology-investment agreement with ARMI to establish the institute.

More than 20 technical experts participated in the selection process and represented four federal government departments or agencies. DoD representatives included members of five military services and agencies, he added.

"This agreement, awarded by the Army Contracting Command, provides for seven years of operation with financial support supplied by a combination of $80 million in DoD funds and more than $214 million in non-federal cost sharing," Kendall said.

"This financial support offers ample evidence that industry is fully behind this initiative. This is truly a team effort," the undersecretary said.

Public-Private Partnership

The Advanced Tissue Biofabrication team -- organized by ARMI and led by engineer, inventor and entrepreneur Dean Kamen -- consists of 47 companies, 26 academic institutions and 14 government and nonprofit organizations, all supporting the industry-driven nonprofit public-private partnership, Kendall said.

"Members of the partnership include small through large businesses, DoD research and development laboratories, public and private universities, research institutions, federal and state government entities and local governments. Who are all collaborating to meet future defense and commercial requirements," he added.

ARMI will bring current and future members together in a collaborative space in Manchester, Kendall said, and "key state partners in the ATB-MII have pledged substantial support." Researchers at Lawrence Livermore National Laboratory say the precision and 3D structures made possible through bioprinting are enabling them to more effectively reproduce human physiology outside of the body, which will eventually lead to a better representation of each tissue system that makes up the human body. Department of Energy graphic Researchers at Lawrence Livermore National Laboratory say the precision and 3D structures made possible through bioprinting are enabling them to more effectively reproduce human physiology outside of the body, which will eventually lead to a better representation of each tissue system that makes up the human body. Department of Energy graphic

They are New Hampshire, Massachusetts, Connecticut, Ohio, Wisconsin, Minnesota, Indiana, North Carolina, Florida, Tennessee, Texas, California, Colorado, Washington, Arizona, New Jersey, Pennsylvania, New York and Maryland.

"I don't think you want to be left out of this activity," Kendall said.

Regenerative Medicine

The ATB is an investment in manufacturing and testing technologies to advance the state of the art in regenerative medicine, the undersecretary said.

"The `why' for this institute is one that is extremely important to all of us and personal to many of us in the Defense Department -- restoring form, function and appearance for our wounded warfighters and changing what is possible for the many Americans who've spent far too long on the organ- transplant waiting list," he added.

The institute encompasses state-of-the-art tissue manufacturing, cell and biomaterial processing, 3-D bioprinting, automation and nondestructive testing technologies, Kendall said.

"The biggest challenge to widespread availability for emerging manufacturing tissue products is in common technologies, processes and standards to advance manufacturing, product testing, quality control, quality assurance and product preservation," the undersecretary said.

Cells, Tissues, Organs

It's necessary, Kendall said, to create and sustain an industrial commons - - a foundation of knowledge and capabilities -- "for the ATB-MII to advance the standardization of tissue products and processes for widespread use across industries in areas such as cell therapies, engineered replacement tissue and biopharmaceutical products."

Scaling up manufacturing processes to produce cells, tissues and organs at scale "will catalyze disparate supply-chain elements and enable novel products for the Defense Department and the larger health-care sectors," he added.

The challenge is amplified in medicine, Kendall said, because of the complexities of scaling and especially the unique nature of tissue engineering. Video Player 00:00 | 02:34 VIDEO | 02:34 | The NIH 3D Print Exchange

Developing these processes for ATB-MII will be a team of engineers led by Kamen.

From Science to Industry

Kamen's inventions include the Segway human transporter, the first drug- infusion pump, portable dialysis machines, a water purifier, an all-terrain electric wheelchair and, working with the Defense Advanced Research Projects Agency, the DEKA-Luke prosthetic arm.

About the arm technology, now approved by the U.S. Food and Drug Administration, Kamen described it at the White House as, "making arms for some of these young [military] heroes who desperately need and deserve something more than a stick with a hook on it."

Describing the job of developing the infrastructure scientists need to turn their science into products for people who need them, Kamen said, "We can supply essentially what the printing press did to get all these ideas to the world that needs them. We need to essentially make the printing press for the world of regenerative medicine."

And that's not just an analogy, Kamen added, "It's a real printing press -- we'll be printing 3-D organs." Kidneys, he said, may be one of the first organs to be produced.

The inventor said he and his team of engineers will give the scientists the tools they need to turn what is now an incredibly exciting science into an industry "that will meet the needs, first of your soldiers who need skin for burns and organs because of what they lost, but then the rest of the country and the rest of the world will benefit."

(Follow Cheryl Pellerin on Twitter: @PellerinDoDNews)