Dean Kamen Opens Organ-Building Institute

BioFabUSA will bring together public and private companies to “a machine shop of 21st-century advanced biomanufacturing”

3 min read
Dean Kamen, dressed in a black button-down shirt, speaking at a lectern
Photo: ARMI/BioFabUSA

On Friday afternoon, New Hampshire Governor Chris Sununu bounded onstage in Manchester like a high school quarterback at a pep rally. “You guys excited?” boomed Sununu. “You should be! This is awesome.”

Sununu was one of a parade of state and federal dignitaries lavishing praise and congratulations on inventor Dean Kamen at the official launch of BioFabUSA, a public-private partnership meant to bring together the technologies needed to create human organ factories. “We are here today on the birth of an entire new industry,” exclaimed Sununu.

A crowd of about 300 gathered for the event at the Manchester Millyard, a picturesque row of refurbished mill buildings that also house several of Kamen’s companies—including Deka Research and Development, home to the Luke ArmFIRST, a popular high school robotics competition; and BioFabUSA’s organizer, the Advanced Regenerative Manufacturing Institute (ARMI). (Kamen is perhaps still best-known for his invention of the Segway motorized vehicle.)

In December 2016, the DoD awarded ARMI US $80 million over 5 years to scale-up manufacturing of human tissues and transplant organs, especially for injured soldiers and vets. Industry and university partners contributed an additional $214 million to the effort, and Kamen set up a headquarters for ARMI at the Millyard. BioFabUSA is the company’s first big effort. It’s designed to bring together companies, academics, and nonprofits to build and scale-up all the technologies needed to create human organ factories. In other words, “a machine shop of 21st century advanced biomanufacturing,” said ARMI chief regulatory officer Richard McFarland.

The ARMI sign includes three hexagons: purple, blue, and red. The sign next to ARMI says BioFabUSA. Photo: Megan Scudellari

Today, tissue and organ bioengineering is largely restrained to academic laboratories and tissue engineering start-ups. “The problem is the incredible work being done in laboratories, mostly funded by other government agencies like NIH and NSF…is just not getting through” to commercialization, Kamen told the crowd.

Yet how far that $294 million will go toward creating a new manufacturing industry in the United States remains to be seen. Kamen willingly admits he doesn’t know anything about regenerative medicine, and the three-hour long launch party was light on science and heavy on marketing. Kamen touted his past successes with Deka and FIRST at length, while several of the ARMI staff just lightly touched on what will be needed to manufacture organs and tissues. There are currently no biomanufacturing facilities at the Millyard—just office space and a few laboratories shared with Deka Research.

A white box in front of a brick wall. Robotic instrumentation and lighting appear inside. Advanced Solutions' BioAssemblyBot was one of several bioengineering technologies on display at the BioFabUSA launch. Photo: Megan Scudellari

Kamen and ARMI staff showed slides with logos from roughly 80 companies and 26 academic and nonprofit organizations committed in BioFabUSA, but project manager Stephanie Robichaud later confirmed to IEEE Spectrum that no one has officially become a member yet, as the membership agreement is still being finalized. Organizations will pay an undisclosed fee, or contribute a similar amount in lab space, personnel, etc., to become members. Members will be able to join projects with other partners and tap into ARMI’s wealth of regulatory and IP experience, among other benefits, the company stated. So far, one scientific project has been approved by the ARMI management board. A new call for proposals was announced on Friday, with preliminary proposals due 11 August. 

Near the end of Kamen’s remarks, DoD officials, the governor and New Hampshire senators gathered for a ribbon cutting, complete with a massive pair of cartoon scissors. Kamen concluded his remarks, saying, “This day is going to be a day that history remembers as very significant.” The crowd applauded.

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This CAD Program Can Design New Organisms

Genetic engineers have a powerful new tool to write and edit DNA code

11 min read
A photo showing machinery in a lab

Foundries such as the Edinburgh Genome Foundry assemble fragments of synthetic DNA and send them to labs for testing in cells.

Edinburgh Genome Foundry, University of Edinburgh

In the next decade, medical science may finally advance cures for some of the most complex diseases that plague humanity. Many diseases are caused by mutations in the human genome, which can either be inherited from our parents (such as in cystic fibrosis), or acquired during life, such as most types of cancer. For some of these conditions, medical researchers have identified the exact mutations that lead to disease; but in many more, they're still seeking answers. And without understanding the cause of a problem, it's pretty tough to find a cure.

We believe that a key enabling technology in this quest is a computer-aided design (CAD) program for genome editing, which our organization is launching this week at the Genome Project-write (GP-write) conference.

With this CAD program, medical researchers will be able to quickly design hundreds of different genomes with any combination of mutations and send the genetic code to a company that manufactures strings of DNA. Those fragments of synthesized DNA can then be sent to a foundry for assembly, and finally to a lab where the designed genomes can be tested in cells. Based on how the cells grow, researchers can use the CAD program to iterate with a new batch of redesigned genomes, sharing data for collaborative efforts. Enabling fast redesign of thousands of variants can only be achieved through automation; at that scale, researchers just might identify the combinations of mutations that are causing genetic diseases. This is the first critical R&D step toward finding cures.

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