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With $294M, Kamen Hopes to Bring Regenerative Medicine “Up to Scale”

Xconomy Boston — 

Dean Kamen is, among other things, an inventor, entrepreneur, and leader in the technology and nonprofit fields.

The products he and his company, Manchester, NH-based DEKA Research & Development, have helped create over the years include the first portable insulin delivery system, an electronic wheelchair that can climb and descend stairs, a robotic prosthetic arm, and the Segway.

In December, the U.S. Department of Defense announced that Kamen, an Xconomist, would be helping to lead a coalition of 87 businesses, academic institutions, and other organizations in an effort to advance regenerative medicine and tissue engineering. The DoD said the mission of the consortium, known as the Advanced Regenerative Manufacturing Institute, or ARMI, is to develop “next-generation manufacturing techniques for repairing and replacing cells, tissues and organs for wounded service members.” So far, ARMI has secured some $294 million in funding commitments, including $80 million in defense money.

Kamen recently spoke with Xconomy about how he got involved with the new initiative, what he and other project leaders are hoping to achieve with it, and other topics. Our conversation has been edited for clarity.

Xconomy: Why did you choose to pursue the field of regenerative medicine versus others?

Dean Kamen: I can’t say I got up one morning and decided to pursue it. I was actually asked to pursue it. I was approached by a number of people who basically said, “Hey Dean, we know you’re a technology guy. We know you play with all sorts of technologies.”

X: What are some of the reasons for launching this program, and what is it hoping to achieve?

DK: There’s a huge opportunity because there is mounting excitement in the laboratories, in the petri dishes, in the roller bottles, in 3D printing—which I have been doing for years, long before it was popular—that’s finding its way into the medical and biological research communities.

There’s all this great science going on but there aren’t a lot of companies that are looking for ways to take this magic out of the roller bottles—these one-at-a-time miracles—and go from science experiments to industrial scale to meet the needs of hundreds of thousands of people waiting for organs or tissue. And as this magic gets better and better at the scientific scale of all these labs and all these medical schools around the country, let’s create an opportunity for them to have the right tools to meet the needs—the desperate needs, in many cases—of people.

There’s loads of funding at the medical school level, at the biology level, at big pharma. But there aren’t a lot of industry people that are going to help bring this up to scale. It was actually very exciting and relatively easy to get some of the visionary leaders from the right industry to say, “Hey, count us in. Let’s make this happen.” They all said the same thing: “We’d love to bring our industry and our expertise to help the medical industry turn its dreams into reality.” So we did it.

X: How will you and other leaders at the institute decide which projects to fund?

DK: We’re desperately trying to figure that out. I told everybody the same thing: “Look, you all have your own vision. You all have some potential magic that you’ve already demonstrated in that petri dish or roller bottle. But we’ve got to get you all together to figure out what are the most important common needs that you all have.”

What are the things that, if we did this once and did it right, could help leverage and catalyze and enable each of your magic pieces, your miracles of science, to become a reality? What are the tool sets you all need so that everybody can be moving quickly and we can make it so the FDA will accept our processes, and the medical community will trust what we’re doing as we start making these things?

The reason it’s hard to prioritize projects is like all decision-making, you look at a bunch of variables and make a choice. If it was a project that you said, “Dean, this is the lowest risk, easiest one to do. It will have the biggest upside. It solves the biggest need,” [then] of course we would do that one first.

But when you look at all these projects, it seems like the holy grail might be [generating] whole organs for people who are waiting for organs. It’s also the one that’s the longest-term, highest risk, and needs the most work.

And then at the other end, there are ones that we think are pretty simple, like being able to print cells into a liquid-like solid, and then monitor them properly to do things in three dimensions that used to only be doable in two dimensions in a petri dish. That’s a really big advance, in some ways. But it’s also relatively straightforward, and it could be used by a lot of our members. A lot of our industry partners are ready to start building the software and hardware to make it happen.

Let’s take small steps that will have some immediate wins and some milestones that show success and meet some needs. And we are trying to develop that plan right now.

But if you right now said, “Show me the roadmap and the list and the milestones for what you guys are going to do,” I’d say, “You’re welcome to get in the room and help us create that list, create those milestones, and give us that roadmap.” That’s the process we’re going through right now.

X: If you look at the industry partners in the initiative, some of them already have regenerative medicine research underway. How is this new program different from what they have already been doing?

DK: There’s already lots of basic research being done, and plenty of funding to support it and experts who know how to evaluate it. We’re not doing any of that. In fact, we continually remind ourselves that we will not get drawn into becoming a de facto alternative to other funding sources for basic research or creating these scientific breakthroughs. Instead, we say, “Look, we want to be a resource to all of these researchers. We want to build the appropriate tools and the appropriate processes to take whatever is their particular achievement and bring it to scale quickly.”

We want to have processes in place to deal with agencies like the FDA to make sure that we can effectively support, in the appropriate ways, all the stuff that needs to be done to get into and get out of clinical trials…to bring things to scale, to get quality up and cost down as we transition these things from science to industry. That’s the focus of what we’re going to do. We will not be doing the basic science. We will be doing the transition to volume—qualified, reliable systems.

X: Will the institute have a designated staff, lab and office space, et cetera?

DK: We set up a not-for-profit that we call ARMI. It was important to us [for the name to include] “manufacturing,” not “medicine.” We are bringing the technology to the medical community. We thought it was appropriate to call it ARMI because it’s being [partially] funded by the Department of Defense and because with a lot of the early stuff that we will be doing, the focus will be on meeting the needs of war fighters.

We have been trying to get a good cross-section of pharma companies, industrial companies, medtech companies, [and] little startups coming out of university labs.

ARMI is centered here in New Hampshire. Early on, a lot of my DEKA folks are doing the work to help set it up and organize the meetings with all the researchers and industry partners. We took a whole building in the [Manchester] Millyard next to one of [DEKA’s] and are in the process of building lab space in it now, specifically to be used by members in the consortium. We are also in the process of finding people to lead ARMI internally.

X: Will all projects that receive funding be required to have some potential application for the military/defense department?

DK: That was one of the first questions I asked the DoD folks. Their answer, I think appropriately, was “Let’s be serious here. Nobody knows how to predict, with any accuracy, where a given technology will end up being useful.” They said, “Dean, we’re trusting you and your judgment and the people around you to understand that we expect regenerative medicine will be useful to all citizens of this country, and eventually all citizens of the world. But we would hope that we will give special attention early on to applying what we’re doing to meet the unusual and specific needs of our war fighters, who deserve some special attention when they come back missing a limb or with severe burns or missing bone and tissue.”

So we said, “Obviously, anything that we can do to help these people will of course help the whole field of medicine and lots of other people.” We are highly sensitized and motivated to direct a lot of our early work to be sure that it can meet the needs of the military. One reason is that they’re a big source of funding. Another is that a significant reason that I and many people are involved in this program is we feel committed to give back to these people that are giving so much for us. In many cases, literally they’ve given their arms and legs for this country. We owe them a lot.

X: Did the results of the presidential election cause you to feel any more or less optimistic about the institute’s ability to attract additional funding from the government?

DK: Of the many subjects I have little to no expertise in, politics is probably near the top of that list. And I’m going to try to spend the rest of my life keeping it that way. I think we will understand all the fundamental laws of this universe of ours long before I understand politics.

I have been simply told that this program is important. I have been told, “Look at 21st Century Cures,” which was passed bipartisan. Everybody in Congress knows people that are suffering with cancer and diabetes and who are waiting for organs.

I have been told that it is unlikely that we should see any hiccups because there was a political change that occurred during the time this happened. I would be surprised if anything we’re doing will be affected by politics. Curing disease is not a political problem—it’s a technical one.

X: Have you been told that the recently announced short-term federal employee hiring freeze will have any direct impact on the ARMI program?

DK: No. I have heard nothing like that. I have heard nothing to the contrary, either. I’ve had no conversation with anybody on that subject.

X: How far do you think the $294 million in funding commitments that have been made to date will take the program?

DK: We told the DoD that by the end of five years of our development, there should be enough successes that have reached industrial capability to be out there meeting the needs of people. By definition, if that occurs, this organization will be self sufficient and will be in a position to keep going without any federal funding and its partners will be putting in resources and benefitting by being able to put products in the field that are highly attractive and needed. Presumably the marketplace will then allow this thing to keep getting funded and keep growing.

X: Even though it’s still really early, how would you compare the work of starting and heading up ARMI versus your experiences as an inventor and at other career stops?

DK: My day job [at DEKA] is mostly making medical stuff, which I have been doing for big companies around the country for decades now. But I also many years ago started FIRST (For Inspiration and Recognition of Science and Technology). It’s a coalition mostly of technology companies and universities [that organizes] robotics competitions [and other programming].

My vision for ARMI and my vision for my place within ARMI is a hybrid of my position inside DEKA leading commercial development and my position as the founder of FIRST: to keep steering it and keep herding all the cats from industry and academic institutions, not-for-profits, and foundations, to make it all work together.