There’s more to the National Cancer Institute and the National Institutes of Health than most biotech companies realize. The Institutes have hundreds of innovations ready for licensing and a plethora of opportunities for collaborative development available to companies of all sizes as well as universities, foundations and research institutes. Many of those opportunities remain untapped, largely because researchers don’t know they exist.
Five myths that stop researchers in their tracks
When companies think about working with the NCI Technology Transfer Center (which handles technology transfer for 10 of the NIH’s 27 institutes), one of five key misperceptions stops many from investigating the full range of opportunities.
Myth 1: The NCI only conducts basic research.
Reality: “We conduct a lot of basic research, but many of our assets have proof-of-concept data and some have clinical data,” points out Michael L. Salgaller, PhD, supervisor, Invention Development and Marketing (IDM) Unit within the Technology Transfer Center.
Myth 2: The NCI only develops drugs.
Reality: The NCI develops medical devices, diagnostics, software, and digital and wearable health devices in addition to drugs, although therapeutics do make up a sizeable percentage of its docket.
Myth 3: The NCI is a huge, cumbersome, difficult to-work with, bureaucracy.
Reality: The NCI’s Technology Transfer Center knows time is people’s lives—and company’s money. Its staff of 60 signs several agreements per day for the NCI alone. “There’s no way we could be bureaucratic and accomplish that much,” Dr. Salgaller says. “Our staff is comprised of very well-trained professionals, so they are very good at executing deals by identifying how best to meet client needs.”
Myth 4: The NCI doesn’t offer exclusive licenses.
Reality: Licenses can be exclusive, depending upon the asset. They are negotiated individually, so although “exclusivity isn’t always possible, the option often exists.”
Myth 5: The NCI only works with American companies.
Reality: The NCI is geographically agnostic, working with entities throughout the world. In additional to companies, it also works with a wide range of stakeholders—including foundations, economic development entities, universities and research institutes. “The Technology Transfer Center can work with virtually anybody anywhere in the world. Because we’re near Washington, DC, we have a lot of meetings at embassies with countries that are interested in improving healthcare and spurring economic development,” Dr. Salgaller says.
Explaining the global nature of work at the NCI Technology Transfer Center, Dr. Salgaller emphasizes, “Our mission is to get medical solutions to patients. We can’t commercialize products ourselves. The only way we can advance those technologies—so they can be brought to market where they can help people—is transferring them to outside parties. The IDM unit works exclusively to proactively bring stakeholders together, such as by arranging partnerships between outside entities and the NCI’s internal researchers.”
Perhaps surprisingly, the NCI allocates 90 percent of its research funding budget to investigators throughout the world. Only 10 percent goes to researchers on NIH campuses.
“The Technology Transfer Center was very busy before the Invention Development and Marketing Unit was created, yet a high percentage of very promising technologies aren’t licensed and aren’t part of a cooperative agreement,” he says. Many of those technologies are competitive but haven’t been marketed. The IDM’s mission is to address the technologies that are sitting on the shelf or that could be licensed for other disease indications.
In addition to out-licensing technology, the NIH also can help companies advance technologies originating within the companies themselves. For example, a company with a feasible drug may need a targeted delivery vehicle, while an NIH researcher may have an improved delivery system and need innovative drugs for proof-of-concept. Talking with the NCI Tech Transfer team may trigger introductions that resolve the challenges for both research groups.
The NCI may also be able to identify patients for clinical trials. For example, Dr. Salgaller says, “One company developed a medical device to measure sleep apnea, but had no patients with the condition. We connected the company to an NIH clinical researcher who was conducting a human study involving quality of life impacts for a particular drug. One of those impacts was severe sleep apnea.” Collaborating solved major challenges for each researcher, helping the device developer to clinically validate the device and helping the NIH researcher remotely monitor patients (potentially accelerating study participation).
Organizations of literally any size may work with the NIH, Dr. Salgaller emphasizes. “We want to meet as many potential ‘partners’ as possible.”
Companies typically approach the NIH through its Web site. “A company could use it to identify NIH researchers working in a particular field and contact them directly, or contact the technology transfer manager. Accessing the Web site is particularly helpful when researchers are shopping around for technology.”
The Invention Development and Marketing Unit adds to that by actively reaching out to companies at conferences and through the media. Rather than touting what the NCI offers, Dr. Salgaller and his team engage in ‘reverse engineering.' They talk with organizations about their specific challenges before offering solutions. This may reveal a technology they need or a gap in their development program the NIH can fill. “Once we do that, we can discuss our innovations. Since we have thousands of investigators, we probably have a technology or investigator to address their pain points.”
The time it takes to close a deal varies. “Most licensing deals can be completed in less than six months. We realize that time, literally, is money and that a company needs to complete the transaction as quickly as possible,” Dr. Salgaller says.
The NCI also has a number of low- or no-cost programs for its partners, including research tools such as cell lines, mice or antibodies. “We also have a regulatory affairs branch that can provide input on a company’s regulatory strategy, as well as insights into formulations and manufacturing.
“We can provide a lot of in-kind support,” Dr. Salgaller says. “Such non-dilutive indirect support is very good. It represents dollars companies don’t have to spend to advance their technologies, and is a little-known benefit of working with the NIH.”
The NCI Tech Transfer Office manages tech transfer from the:
- Center for Information Technology
- National Cancer Institute
- National Center for Complementary & Integrative Health
- National Eye Institute
- National Institute of Aging
- National Institute of Child Health and Human Development
- National Institute of Minority Health & Health Disparities
- National Institute of Drug Abuse
- National Institutes of Health Clinical Center
- National Library of Medicine