When four Duke researchers developed an innovative technique for exploring the non-coding genome—the 98 percent of our DNA that does not encode protein sequences, often called the genome’s “dark matter”—the implications were clear. Their approach, using technologies including CRISPR gene editing to shed new light on gene regulation, has enormous potential to guide development of new drugs to combat a host of genetic diseases.
The question the researchers then faced was: How best to develop those new therapies in order to make them available to patients? The answer: Take the work beyond the academic lab and into the world of commercialization.
The four researchers—Greg Crawford, PhD, associate professor of pediatrics; Charlie Gersbach, PhD, Rooney Family Associate Professor of Biomedical Engineering; Tim Reddy, PhD, associate professor of biostatistics and bioinformatics; and Kris Wood, PhD, assistant professor of pharmacology and cancer biology—launched a startup company called Element Genomics. Last spring, Element made big news when a global pharmaceutical firm, UCB, acquired it for $30 million.
Element Genomics is emblematic of the growth of academic entrepreneurship, increasingly the path of choice to move innovative new biomedical technologies, devices, techniques, and other advances from the lab to the marketplace, where they can be deployed to benefit patients.
“We all want our work to have impact in the world,” says Wood. “And it’s great to see that, increasingly, faculty at Duke are able to take discoveries in their labs and not only publish those results to advance scientific understanding, but also leverage those discoveries to start companies that ultimately connect the science to consumers and patients.”
Navigating the maze
Scientists are experts at doing science. They tend to be less conversant in matters like raising capital, negotiating industry contracts, and navigating commercial licensing and regulatory requirements.
Fortunately, Duke has a number of people who are experts in those areas, and they are on hand to help. Element Genomics benefitted greatly, for example, from the Duke-Coulter Translational Partnership, directed by Barry Myers, which supports translational research collaborations between the Duke Department of Biomedical Engineering and clinical units of Duke Health. John Oxaal, the Pratt School of Engineering’s first entrepreneur-in-residence, also played a key role in bringing Element Genomics to market, and served as the company’s CEO.
The main conduit between academic innovation and commercial enterprise at Duke is the Office of Licensing & Ventures (OLV), the university’s technology transfer office. OLV partners with faculty and staff, industry, and investors to help discoveries and innovations birthed in Duke labs reach the marketplace for the benefit of society, and to enable future investment in Duke research and innovation. That means guiding innovators through the complexities of analyzing the market and competition, securing patents, connecting with potential industry partners, raising capital, exploring options for licensing or launching a startup, negotiating deals, managing expenses and revenue, and more.
While Element Genomics was one of the quickest faculty startups to move from lab to launch to sale, it was far from the first. Last year alone, OLV received nearly 350 invention disclosures from Duke faculty, staff, and graduate students interested in moving their innovations from the lab to market. The majority of these inventions—about two-thirds—are related to improving health care through biomedical therapeutics, medical devices and diagnostics, and other innovations.
OLV was instrumental in the launch and acquisition of Element Genomics.
“Even before we knew we wanted to start a company, OLV was diligent in ensuring that we were properly filing new inventions, so when we were ready to start a company, we were able to transfer that technology,” Gersbach recalls. “OLV was incredibly helpful and responsive in getting the licensing deal complete, which was essential to our fundraising efforts and played a key role in the negotiation with the acquirer.”
Trust the process
Rob Hallford, MBA, director of new ventures at OLV, says that technology transfer offices like Duke’s date back to the 1980s, when the Bayh-Dole Act gave universities ownership over intellectual property (IP) that came out of employees’ federally funded research.
“While Duke officially owns the IP, there’s a huge benefit to our innovators as well,” Hallford explains. “We work with them to understand the opportunity, protection strategies, and potential licensees and partners, and can help them think through strategies to maximize the value of their invention.”
Interest in innovation and entrepreneurship across campus is growing, as evidenced by the rising numbers of invention disclosures OLV receives. Even before receipt of a formal disclosure, OLV staff are available to meet with each innovator or team of innovators to discuss their idea. Is it protectable via patents or copyrights? Is there a market for it? Is there an unmet need that it can fill? Are there competing products or technologies already in the market?
The team discusses whether the innovation is more appropriate for a startup or licensing to an existing company, and OLV experts help the inventors navigate the process, drawing on relationships with key players in industry, potential investors, partners, management teams, and laboratory space/incubators, as well as resources at Duke and beyond.
When innovations do lead to commercialization, revenue generated from them is shared according to the Policy on Patents, Inventions and Technology Transfer in the Duke Faculty Handbook. Once OLV recoups any unreimbursed costs of patent protection, all remaining revenue is shared among the innovator(s), their department, lab, and school, with a sliding scale as revenues increase. (For example, for the first $500,000, the inventors’ share is 50 percent; if revenues surpass $2 million, the inventors keep 25 percent.)
“We have some innovators who have been through this process many times and may need different types of assistance than others where it’s their first time and they need help understanding appropriate expectations, the process, how to work with industry,” says Robin Rasor, MS, who became executive director of OLV in 2016. “We also recognize that each innovator has different goals and objectives, so it’s our job to put teams around people to help them achieve the best possible outcome.”
The most successful technology transfers, Hallford notes, happen when a researcher sees a space in the market where things aren’t optimal—where patients aren’t getting the care they need, for instance— and steps up to devise creative solutions to the problem.
For Howard Levinson, MD, associate professor of surgery, the problem was an almost 25 percent failure rate in the mesh used for hernia surgeries. Levinson worked with textile experts at North Carolina State University to develop a new mesh with enhanced anchoring strength to resist wounds from gapping and bursting open. With its simple yet revolutionary design, the T-Line Mesh has the potential to reduce hernias by preventing or reducing mesh fixation failure.
Levinson turned to OLV for help in filing patent applications, securing technology enhancement grants, and advancing toward commercialization. With OLV’s assistance, he started Deep Blue Medical Advances, Inc., and has licensed the IP in several countries.
“My dream has always been to perform research to improve patient care,” says Levinson, Deep Blue’s chief medical officer.
“As a surgeon, I can heal with my two hands and help a few thousand patients in a lifetime. But as a surgeon/scientist/entrepreneur I can heal with many hands and perhaps help tens of thousands of patients or more in a lifetime.” -Howard Levinson
The evolution of translational medicine at Duke has opened new opportunities for Levinson and his colleagues to make that dream a reality in an emerging landscape.
‘Change the world’
Duke medical oncologist and palliative care specialist Arif Kamal, MD, MBA, MHS, was concerned about the high percentage of palliative care patients—some 40 percent—who don’t show up for appointments, increasing the cost and reducing the quality of their end-of-life care. He built a suite of mobile apps to help patients and families take control of managing their disease. Kamal had the medical and technology background to design the apps, but not the business acumen to make them available to a wide audience.
“I walked into OLV and said, ‘I’ve got a great idea; now I want to change the world. How can you help me?’” Kamal says. “And the OLV folks said, ‘Great! Let’s help you go change the world.’”
OLV helped Kamal and his team figure out how to commercialize and protect his intellectual property. The office also helped connect Kamal to experts and thoughtleaders around the university who could help guide and mentor him. Kamal and his colleagues launched Prepped Health, LLC, which offers app-based products that help demystify palliative care and empower patients facing serious illnesses. The company is in conversation with potential partners and investors, as well as groups interested in mergers or acquisitions.
“Our company really got launched because of the relationships we made with folks OLV connected us with,” Kamal says.
“At a place like Duke, there are lots of smart people and great ideas floating around. The question is: How do we impact the world broader than our own campus?” -Arif Kamal
Expanding the reach of research
Rasor, who previously held leadership positions in tech transfer at the University of Michigan and Ohio State, jumped at the chance to come to Duke—in part because its focus on multidisciplinary collaboration makes it ripe for academic entrepreneurship opportunities.
“One of the great things about Duke is that there’s such a collaborative environment,” she says. “As a result, many invention disclosures include inventors from multiple colleges and departments.”
That environment, she says, is increasingly important.
“If you want to recruit great faculty and students these days, you absolutely must have an innovative environment,” Rasor says. “More and more, faculty candidates want to know about the tech transfer office and entrepreneurial resources. They often arrive at Duke with preexisting inventions and sometimes startup companies, they plan on continuing development of these inventions, and they want to talk to us before they come here.”
Commercialization also helps advance science by generating diverse funding streams beyond the traditional ones available through federal agencies.
“Diversification can now include options not traditionally available to researchers,” says Kamal. “Entrepreneurship provides researchers unique options for sustainability.”
Most importantly, Rasor says, lowering the barriers between biomedical research and industry can hasten the delivery of therapeutic interventions to the people who need them.
“Part of Duke’s stated mission is to help those who suffer, to cure disease, and to promote health,” she says. “So it is our job to get these solutions out into the marketplace for the benefit of the public.”
At Element Genomics, the acquisition is helping the founders realize the potential of technologies they developed at Duke to create new medicines. It’s also helping create jobs—Element employs a number of Duke alumni—and stimulate biotech activity in Durham. The company will remain based in the newly renovated Chesterfield Building on West Main Street, a former tobacco factory that Duke has transformed into a gleaming hub of biotech and advanced science (See sidebar).
Most Duke startups remain in this area, providing opportunities for employment and growth throughout the Triangle. “These companies need the type of expertise that Duke alums have, whether it’s clinical, professional, or scientific leadership,” Hallford says. “There are real opportunities here for people who have the right skill set to take things forward and really make a difference.”
This expertise is particularly needed, because most faculty stay at Duke even after their companies launch.
“Taking those first steps was frightening, but also exhilarating,” Wood remembers. “We hope that our success galvanizes other scientists at Duke to think similarly about how they can convert their discoveries into commercial opportunities.”