The National Institutes of Health (NIH) is a critical pillar of the U.S. public health system and a beacon of guidance for healthcare best practices across the globe. This has never been more evident than during the COVID-19 crisis.
A lesser-known NIH facet is its long and productive history of technology transfer success.
Technology or Tech Transfer is the process by which inventions and innovations discovered in a research institution are potentially turned into commercialized products.
It’s important to note that Principal Investigators “spinning out” companies while maintaining their government positions are prohibited at the NIH. All innovations and inventions originating at the NIH must follow the Federal Technology Transfer Act, meaning NIH technology can be commercialized only via partners through a licensing or a Cooperative Research and Development Agreement (CRADA). This agreement is typically between the institution, in this case the NIH, and a company, entrepreneur looking to form a startup, or even a tech scout hired to find innovations on behalf of a large corporation. The NIH’s tech transfer program is open to working with such partners in therapeutics, diagnostics, biotech, vaccines, software, and research tools.
Within the 27 Institutes that comprise the NIH, a host of larger Institutes have internal tech transfer programs; the National Cancer Institute (NCI), located in Rockville and Frederick, Maryland, includes the NCI Technology Transfer Center that manages tech transfer for NCI and nine other NIH Institutes. Scores of NIH discoveries and life sciences-related technologies have been licensed out of its research labs.
The NIH’s robust tech transfer program has been a wellspring of founding technologies and CRADAs that have sparked the creation of many successful life sciences companies in the BioHealth Capital Region (BHCR) and beyond.
NIH Technology Transfer Success Stories
The NIH tech transfer program has many success stories in the life sciences as well as other industries. This story will focus only on tech transfer success stories in the biotech and biopharma spaces. Among many, here are four tech transfer collaborations that yielded significant results.
One of the most well-known and remarkable tech transfer research collaborations occurred between the NIH and Merck & Co, which resulted in the FDA approval of GardasilⓇ, a vaccine protecting against human papillomavirus (HPV), the primary cause of cervical cancer. Key elements that led to the creation of Gardasil originated from the lab of Drs. Douglas Lowy and John Schiller of the NCI.
Kite Pharma, which recently received FDA approval for its manufacturing facility in Frederick, Maryland was founded on technology transferred out of an NCI lab. Kite, before being acquired by Gilead in 2017, collaborated with NCI to license technology developed by immuno-oncology and gene therapy pioneer Dr. Steven A. Rosenberg. This NCI technology, licensed to Kite in 2014, eventually led to the development of FDA-approved YESCARTAⓇ, Kite’s approved CAR-T immunotherapy for a type of non-Hodgkin lymphoma. In addition, a significant segment of Kite’s current pipeline is also based on this same NCI technology. The power and promise of the NCI technology licensed by Kite are evidenced by Gilead paying $11.9 billion to acquire Kite without the company having an approved product at the time.
Avelumab, commercially known as BAVENCIO®, is a pioneering Merkel cell carcinoma treatment developed as part of a co-development agreement between EMD Serono, the biopharma division of Merck KGaA, and the NCI Tech Transfer Center. In 2017, avelumab was the first checkpoint antibody approved by the FDA for this lethal form of skin cancer. During the Phase 2 trials, NCI and EMD Serono entered into a CRADA for avelmulab. Just four years after the first NCI-led studies, avelumab received FDA approval for Merkel cell carcinoma and an additional indication. Merck KGaA and Pfizer entered into a collaboration to jointly develop and commercialize BAVENCIO® (avelumab) in a deal worth up to $2.85 billion for Merck KGaA. The collaboration has been recognized by GEN as one of the top 10 Immuno-Oncology Collaborations.
miRecule, Inc. a Gaithersburg, Maryland-based early-stage biopharmaceutical company focused on developing microRNA-based therapies for drug-resistant cancers, is another startup company that was founded on licensed technology from NIH. It’s CEO, Dr. Anthony Saleh, completed his post-doctoral training at the NCI. The company and NIH entered into a CRADA for microRNA therapeutics for treating head and neck squamous cell carcinomas. In May, 2021 the company announced it had raised $5.7M in seed funding. More recently, miRecule was awarded a $100K grant from Maryland Industrial Partnerships (MIPS).
Another local company, Veralox Therapeutics, was launched by President and CEO, Jeff Stroval, PhD, around a first-in-class small molecule inhibitor lead compound in development for over ten years at NIH. Stroval obtained the technology, a joint invention between NIH and several universities, through a license from the lead of the partnered research institutions, Eastern Virginia Medical School. Since it was estimated that more than $10M had been invested in the technology prior to the company acquiring a license to it, the value was clear.
These are just a few representative examples of NIH tech transfer success stories and companies well-positioned to thrive; the tech transfer program currently has scores of pre-clinical projects underway that could yield the next tech transfer success story.
The Advantages of the NIH Tech Transfer Program
The NIH tech transfer program has a broad mission that is anchored on developing intellectual property and advancing innovations that benefit public health and stimulate economic development from federal dollars. The NIH tech transfer program is collaborative and mutually beneficial to its partners and the mission of the institution.
The NIH partners with U.S. corporations and entrepreneurs looking to establish new companies. Technology scouts for large corporations also fall within NIH’s target audience and the NIH is also extending its reach to international companies at various life cycle stages.
The benefits of partnering with the NIH tech transfer program are many and go beyond exciting innovations and technologies with potential. NIH partners and collaborators also gain: access to unique resources, reagents, and research tools; access to the institution’s deep scientific and regulatory knowledge; and licensing and intellectual property (IP) development collaboration opportunities with financial agreement terms difficult to find elsewhere.
NIH licensing agreements can take many forms and are developed on a case-by-case basis, but these contracts require no loss of equity—the NIH seeks to cover its costs and get fair value for the public dollar investments made.
If an NIH and partner collaboration yields exciting new IP, the NIH continues to own or co-own the IP it solely or jointly invents and charges modest milestone and royalty fees for a partner to receive these rights. What’s more, a NIH partner is granted “right of first refusal” to negotiate a license to the IP generated under a CRADA, eliminating risk that a competitor could swoop in and take an asset. The NIH is also prohibited from directly spinning out a company to compete for the newly created IP asset.
In short, collaborations and licensing with the NIH is non-dilutive and no indirect costs are usually incurred. The NIH doesn’t take equity like most universities and research institutes do, and it cannot take the IP from a collaborator. A CRADA with the NIH provides favorable financial terms along with access to the technology validation infrastructure, vast scientific and regulatory resources, and the prestige that comes with partnering with the globe’s preeminent research institution.
To explore potential collaborations with the NIH and NCI Tech Transfer Center, contact:
PhD, Supervisor, NCI, Technology Analysis and Marketing Unit
MBA, Special Advisor, NIH Office of Technology Transfer