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The New Frontier of Medicine

With the effort well under way to design and commercialize bioengineered medical devices to save untold numbers of lives, Rutgers research, and that of a consortium of universities, is paving the way for the imminent introduction of products that will revolutionize medical care. The man orchestrating the massive effort is Joachim Kohn, the director of the New Jersey Center for Biomaterials at Rutgers.
Story by Leslie Garisto Pfaff • Illustration by Jean-Francois Podevin

Joachim Kohn, a Board of Governors Professor of Chemistry in the Department of Chemistry and Chemical Biology at the School of Arts and Sciences in New Brunswick
Joachim Kohn, a Board of Governors Professor of Chemistry in the Department of Chemistry and Chemical Biology at the School of Arts and Sciences in New Brunswick, is also the director of one of the two branches of the Armed Forces Institute of Regenerative Medicine. He is responsible for roughly 150 scientists at 15 institutions, from Rutgers to the Mayo Clinic, whose shared mission is to apply biomaterials science to the battlefield. And as director of the New Jersey Center for Biomaterials at Rutgers, he oversees one of the world’s leading academic research organizations in the realm of bioengineering, dedicated to not only the discovery of new technologies, but also their rapid application in the world. Photography by John Emerson

When Joachim Kohn was a young man in Germany, his father, the owner of a successful textile factory, draped an arm around his shoulders and said, “Son, if I wanted this place to be bankrupt by noon, I’d make you general manager in the morning.” Kohn took his father’s assessment of his business acumen to heart and pursued a Ph.D. in chemistry instead. Today, Kohn, a Board of Governors Professor of Chemistry in the Department of Chemistry and Chemical Biology at the School of Arts and Sciences in New Brunswick, is a successful entrepreneur and an administrator par excellence. As director of one of the two branches of the Armed Forces Institute of Regenerative Medicine (AFIRM), he’s responsible for roughly 150 scientists at 15 institutions, from Rutgers to the Mayo Clinic, whose shared mission is to apply biomaterials science—Kohn’s specialty—to the urgent problems of the battlefield. And as director of the New Jersey Center for Biomaterials (NJCBM) at Rutgers, he oversees one of the world’s leading academic research organizations in the realm of bioengineering, dedicated to not only the discovery of new technologies, but also their rapid application in the real world.

The real world was imposed on Kohn early in life. The first in his family to go to college, he was the only Jewish student among thousands in his Munich high school class. He never knew his paternal grandparents because they were murdered in the Holocaust, as were seven of his aunts and uncles. Presaging his work for AFIRM, Kohn’s earliest research was conducted for the Israeli army three decades ago. One of the issues that consumes him, he says, is the “translation of science into medical product.” Kohn isn’t content with conceptual science; his mission is to get new technologies rapidly into the market and into the bodies of wounded soldiers and ailing civilians.

And he’s succeeding. Today, more than 20,000 people are walking around with polymers in their bodies that are the result of research conducted in Kohn’s lab at Rutgers, thanks to a research agreement with the medical device company TyRx Pharma, which Kohn founded. Based in Monmouth Junction, New Jersey, TyRx produces a sleeve made of polymer mesh about the size of a silver dollar, designed to hold a pacemaker or an implantable defibrillator; the mesh has an antibiotic coating that dissolves after seven to 10 days, dramatically reducing the risk of infection following implantation.

Biioengineered devices designed by Kohn’s teams
Many bioengineered devices designed by Kohn’s teams are on the cusp of application. The repair of nerve gaps of up to four inches, common in severe arm or leg injury, will be possible through synthetic nerve conduits, upper and middle right, that will promote the regrowth of nerve cells. This polymer stent, lower right, is undergoing successful clinical trials in Germany and Brazil and may be on the market in five years. Biodegradable screws, center, to fix severe fractures as well as bioerodible scaffolds, top and lower left, will encourage the growth of new bone after surgery.

Of course, it’s hard to maintain that sense of the real world when you listen to Kohn catalog the products and technologies that he and his colleagues are in the process of developing. Compared to many of them, the sleeve (known officially as the AIGISRx Antibacterial Envelope) seems downright prosaic. Consider that a good percentage of the products are designed to disappear once they’ve done their job. The company MD3 (now REVA Medical), for instance, approached Kohn’s laboratory in 2002 to help it develop a stent that would keep formerly blocked arteries open after angioplasty and yet degrade once the artery healed. “Most people believe that a stent is there to keep the artery open for the rest of the patient’s life,” Kohn explains. “The truth is that after angioplasty, the artery remodels and heals within about nine months to a year, and the continuous presence of the stent after that becomes a net liability for the patient, potentially interfering with future treatment and increasing the risk of late-stage thrombosis.”

Stents, he says, were always supposed to be degradable—Kohn himself wrote a research proposal for a resorbable stent in 1990, long before metal stents were even on the market. But at the time, no degradable polymer was sufficiently strong to do the job and also visible under X-ray during implantation. (The high molecular-weight compounds known as polymers lend themselves to medical applications because of their versatility; rubber and shellac are examples of natural polymers, and synthetic polymers include nylon and PVC.) Today, polymer science has caught up with Kohn’s vision: the polymer stent he designed for REVA is now undergoing clinical trials in Germany and Brazil, and all the patients now carrying the stent, Kohn says, “are doing remarkably well.” He is hopeful that the device will be on the market in about five years.

Kohn’s lab has close relationships with two other biomedical companies that are developing products to be implanted in the body and degrade after they’ve outlived their usefulness. If you’re one of the five million people in America who suffers from chronically dry eyes, you probably depend on eyedrops, applied frequently, to control the problem. Working with the Kohn laboratory, Lux Biosciences could render those drops obsolete in the near future. The company is developing a so-called “ocular drug-delivery system”—a device just slightly larger, and significantly slimmer, than your average pencil point. It will be implanted against the white of the eye where it will deliver a steady stream of medication for about six to nine months before being resorbed into the body. And if you break a bone in the future, you may be able to thank Kohn and the Somerville, New Jersey-based company Trident Biomedical for helping you heal more efficiently. Together, they’re working on a biodegradable screw to fix severe fractures (which may be on the market in 2014), as well as a bioerodible scaffold—a temporary support into which cells can grow and develop into functional tissue—to encourage the growth of new bone after surgery. Kohn estimates that it could be available in roughly five years.

Teaming Up to Help Soldiers

But it’s Kohn’s association with AFIRM that’s likely to produce the kind of technologies that we think of as futuristic. In 2004, with funding from the U.S. Army, NJCBM had already established the Center for Military Biomaterials Research, whose mission was to draw on the principles of biomaterials science to help solve military health care problems on the battlefield. So when the Army began soliciting proposals for a new initiative that would address the military’s most common, and most confounding, injuries through regenerative medicine, Rutgers and Kohn were already well positioned to deliver what the Army was looking for. “The competition was brutal,” Kohn says, “and toward the end, there were two major competitors running neck and neck.” Ultimately, the Army decided to fund both, creating two research groups: the Rutgers–Cleveland Clinic Consortium, led by Kohn, and the Wake Forest–Pittsburgh Consortium, headed up by Kohn’s good friend Anthony Atala.

Given the urgency of its mission, its cutting-edge science, and the number of brilliant minds it has brought together, AFIRM has been understandably described in the media as a kind of Manhattan Project of medicine. But mention that to Kohn and he’s quick to point out the differences between the two programs. “The Manhattan Project,” he says, “was probably several orders of magnitude more expensive and elaborate than ours. Also, ours is open academic research; the Manhattan Project was highly classified research that was done in the dark. And it was really an offensive program whereas we are defensive: we try to cure.” That distinction is clearly very important to Kohn. “Irrespective of your political world outlook, if you’re a good human being, you’re compassionate toward a soldier who is sacrificing on the battlefield in the belief that he’s serving the nation.”

Kohn doesn’t entirely discount the Manhattan Project analogy, though. He notes that AFIRM is the largest government-run research initiative in regenerative medicine in the world, bringing together 300 scientists and clinicians from 30 of America’s leading scientific and academic institutions, including Carnegie Mellon University, Massachusetts Institute of Technology (MIT), and Massachusetts General Hospital/Harvard Medical School. Between them, AFIRM’s two consortia are likely to create dozens of revolutionary new therapies. In fact, some of those therapies are already, or very close to, being used to save and improve lives. As part of AFIRM, Rutgers supported the nation’s first nearly full facial transplant, conducted at the Cleveland Clinic in 2008. And AFIRM scientists can now create a multiple-square-yard “carpet” of replacement skin, grown from a patient’s own skin cells in a matter of weeks, that will literally mean the difference between life and death for severely burned soldiers and civilians. Because the cells come from the patient’s own body, there’s no risk of rejection and no need for repeated grafting. “We will save the lives of people who are burned over 80 percent of their total body surface with deep, third-degree burns,” Kohn says. “These are absolutely devastating injuries.” (Clinical trials on the technology are expected to begin this year.) As with all therapies aimed at helping soldiers on and off the battlefield, replacement skin will eventually be integrated into civilian care as well. Kohn notes soberly that “if the World Trade Center towers had not collapsed, we would have had hundreds of burn victims instead of thousands of casualties.”

Severe burns are among the most challenging and expensive battlefield wounds—one reason why the skin-replacement procedure was given high priority in the AFIRM program—but one of the most common causes of disability in the military is, in fact, knee injury. AFIRM scientists at the University of Medicine and Dentistry of New Jersey are in the process of developing a scaffold, using fibers invented by Kohn, that would facilitate repair of an injured meniscus, a C-shaped section of fibrocartilage in the knee. (There are two within each knee, one at the outside and one at the inside—which may help to explain why meniscus tears are so common in warriors of both the real and the weekend variety.) The scaffold will attract the body’s own cells to repair the injury, and as the meniscus heals, the scaffold will gradually disintegrate.

Other therapies in the pipeline at AFIRM’s Rutgers–Cleveland Clinic Consortium include the repair of nerve gaps up to four inches long (a frequent result of severe arm or leg injury), using synthetic nerve conduits to support and encourage the regrowth of nerve cells, and autologous fat transfer, a procedure already used by dermatologists in which a patient’s own fat is transferred from one part of the body to another. AFIRM scientists are hoping to apply the therapy to burn victims in order to help reduce the damage and deformity that are caused by extensive scarring (often from third-degree burns), and clinical trials have already begun.

While AFIRM is bringing new technologies to the health care field, it’s also garnering $50 million in grant funding for Rutgers—evidence of Kohn’s prowess as a researcher, certainly, but also of his business and administrative skills. “His ability to administer and manage large, complicated grants is really amazing,” says Francine Newsome Pfeiffer, the director of the Rutgers Office of Federal Relations. “It’s quite clear that all the institutions that are a part of AFIRM are very focused and dedicated to it, and I think that’s a testament to Dr. Kohn’s scientific skills as well as his organizational skills.” In addition, Kohn holds more than 40 patents, many of which have proven highly lucrative to the university. In fact, if you consider only those patents for products at an advanced state in the commercialization process, Kohn’s may be the most valuable in Rutgers’ portfolio, according to Dipanjan Nag, executive director of the Rutgers Office of Technology Commercialization. (Two of them, he says, have the potential to earn upward of $600 million.) Of Kohn’s knack for developing commercial products, Nag says, “I think he is one of the most focused inventors whom I have seen. He has an innate sense of using the right materials and the right design for a specific product, and that is something very few people have.”

Kohn’s powers of persuasion may well have helped to advance research beyond the university and even AFIRM. In 2008, he testified before the U.S. House Subcommittee on Health, explaining how an investment of $4.5 million in his laboratory by the National Institutes of Health (NIH) had generated $120 million worth of venture investment in implantable medical products, providing a 27-fold leverage of government funding by the private sector and creating a significant number of high-paying jobs. “It was the first time that the idea of research spending, and the NIH in particular, came up in reference to the economic stimulus bill,” says Pfeiffer, “and Dr. Kohn was the perfect spokesperson for the idea that the NIH could lead to commercialization.” Thanks, at least in part, to Kohn’s testimony, the NIH was ultimately awarded $10 billion under the American Reinvestment and Recovery Act of 2009.

Given the intricacies involved in administering both AFIRM and NJCBM, Kohn no longer has the time to do research on his own. “Today, I offer a general outline: I select the project, I do strategic guidance and mentoring, but I’m no longer involved in the day-to-day operations in the laboratory,” he says. He isn’t rueful about it: he derives as much satisfaction, he says, from running the “business” of research as he does from the hands-on work of scientific discovery. Ultimately, he notes, it comes down to “impact.” When a doctor works one-on-one to cure a patient, the impact feels huge, he explains. When you’re administering a program that gets your polymers into 20,000 patients, none of whom you actually get to know, the impact feels different, but it’s still huge.

How did a scientist become so adept at translation, the business of moving inventions from the laboratory into the marketplace? Kohn offers his “recipe for success.” First, you need a great invention—“if the science is not strong,” he says, “it’s hard to make gold out of dirt.” Second, you have to have the appropriate institutional infrastructure. “I’ve been blessed with a very supportive administrative structure at Rutgers, more so than I’d find at many other institutions.” Third, you need to know how to communicate your invention to businesspeople who may not have a firm grasp of the science involved. Fourth, you need honesty and high ethical standards, a lack of which can undo all your good work. Fifth, you need to let go. Many faculty members, he says, find it hard to cede control to a professional management team and end up entangled in disagreements and even lawsuits. And sixth? “Just damn luck,” he says.

Certainly, Kohn has been lucky. He’s had excellent mentors, he acknowledges, like Meir Wilchek, his Ph.D. adviser at Israel’s Hebrew University, and Robert Langer, the professor at MIT under whom he completed his postdoctoral work, and, he says, he’s “met the right people at the right moment.” In 1998, for example—eight years after he’d written his first (unsuccessful) proposal for a resorbable stent—he found himself thinking about the idea again, and happened to meet Joan Zeltinger, who was working for a biomedical company called MD3; the chance meeting eventually resulted in a business collaboration to produce the stent. But, driven by a desire to bring his research projects to fruition, he’s also developed an acute business sense along the way. “I’m a late bloomer, and I’m still not perfect,” he says. “But I think my father would have been awfully proud of me.” •