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ARMI effort to grow human organs in NH could see first tissue production by spring 2019

New Hampshire Union Leader

September 20. 2018 2:54PM

Medical student Anna Zhang works on an experiment duiring an ARMI event at the Millyard in Manchester in 2017. Organizers of the Advanced Regenerative Manufacturing Institute hope to have a working production line by next spring that can manufacture biological tissue for a variety of uses in humans. (DAVID LANE/UNION LEADER FILE)

MANCHESTER — A little more than a year after beginning operations in the Millyard, the Advanced Regenerative Manufacturing Institute hopes to reach a major milestone in time for its spring summit: a working production line that can manufacture biological tissue for a variety of uses in humans.

The ultimate aim of the institute, which is a public-private project led by DEKA founder Dean Kamen, is to develop and coordinate the various technologies needed to someday mass-produce human organ replacements and other tissue products.

The first major step toward that goal will be developing a system that turns out simple, standardized tissues — what ARMI Chief Technology Officer Tom Bollenbach calls “sheets and tubes” — that can be mass produced and then incorporated into a wide variety of more complex devices.

“It would be really nice to have it done sometime in conjunction with the spring summit,” Bollenbach said in an interview Wednesday during ARMI’s two-day fall summit.

Now that a tangible prototype is within sight, ARMI used the gathering to look even further forward, to the point where the question won’t be how to manufacture organs but rather how to judge which ones are safe and who will pay for them.

“We’re starting to think about all the other universe of things that need to happen in order to get a tissue into a patient — the (Food and Drug Administration), regulation, reimbursement, who pays for it, how much does it cost,” Bollenbach said.

Officials from the FDA and U.S. Department of Health and Human Services were on hand to discuss the ways they’re already working to collaborate with inventors and their colleagues in federal agencies like the Center for Medicare and Medicaid Services, which will someday be writing the checks.

DHHS Open Innovation Manager Dr. Sandeep Patel and Dr. Murray Sheldon, the FDA’s associate director of technology and innovation, discussed KidneyX, another public-private partnership that is offering funding prizes for companies to work together to create technology that will replace dialysis for patients with end-stage renal disease.

“This is a Manhattan Project and a lot of the prize competitions, as we’ve talked about, have related to SpaceX and automated cars and those are great, but if they fail not much harm occurs,” Sheldon said. “The Manhattan Project couldn’t fail ... this project needs to succeed too.”

Around 80 percent of people with end-stage renal disease don’t get kidney transplants, and 13 people die of the disease every day, he added. Patients on dialysis have poor qualities of life and short life expectancies, but the treatment still costs taxpayers around $34 billion each year.

Unlike many other “prize competitions” in the medical device field, participants in KidneyX will be encouraged to collaborate with each other and government regulators to ensure they move beyond the theoretical and into the practical.

“We need to produce products, not do scientific research,” Sheldon said.

Also on Wednesday, speakers including UNH Manchester Dean Mike Decelle discussed ways to build a workforce with the skills necessary to fuel the regenerative manufacturing industry. During the final session today, speakers are scheduled to address the need for greater standardization and cooperation within the industry.

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