FDA Invents: How Technology Transfer Gets FDA Inventions From Lab to Marketplace

FDA Invents: How Technology Transfer Gets FDA Inventions From Lab to Marketplace

NL FDA Alice Welch interview e1417530360907

Ed.: A longer version of this post originally appeared on the FDA Voice blog in October. We’re reprinting it in keeping with this month’s "Health" theme. It’s a great "slice of life" with some insight into the tech transfer culture at the agency.

If you think the term “government invention” is an oxymoron, well think again. You may be surprised to learn that many of the breakthrough technologies that shape our lives today are the brainchildren of government researchers, including those at FDA.

Like other government agencies, FDA drives innovation in its own mission-critical work by supporting collaborative research with external partners and by transferring our life-saving inventions to the commercial market. Making all of this happen is a dedicated team of experts from across the agency that forms FDA’s Technology Transfer Program. Managed from within the Office of the Chief Scientist, the Technology Transfer Program means many things at FDA.

To our researchers, it means they can access unique resources, participate in scientific collaborations, or obtain the technical expertise they need to make their research possible. These resources support and complement the work underway in FDA’s research laboratories. Whether it’s conducting research into how a blood product becomes a commercially produced therapy, or how to improve vaccine manufacturing, or tracking how patients use a product, the research of FDA’s scientists is fundamental to informing FDA’s evaluation of the safety and effectiveness of our regulated products.

To FDA inventors, Technology Transfer means they can get their inventions translated into commercial products that protect and promote public health. A little known fact is that in the course of their research, FDA scientists regularly gain new scientific insights and invent novel technologies or processes. The Technology Transfer team helps move these technologies to the private sector under license agreements so that new products in areas like vaccines, food-pathogen detection systems, counterfeit drug detection, and manufacturing can be created and made available on the market. To give you a sense of what we mean when we say that “FDA drives innovation,” in the last few years alone, our researchers have produced and reported about 20 patentable inventions annually.

And for FDA’s many collaborators, Technology Transfer means they’re able to engage with our researchers to solve scientific problems and create solutions to support FDA’s regulatory mission. To establish these collaborations and get the right resources for FDA researchers, our Technology Transfer team uses special tools or legal agreements, such as Material Transfer Agreements, Confidential Disclosure Agreements, Research Collaboration Agreements, and Cooperative Research and Development Agreements.

Each of these tools is designed to meet the needs of the research project at hand. They enable FDA researchers to obtain materials not available at the agency and to establish successful scientific exchanges with experts in the scientific community—at universities, small businesses, nonprofits or for-profits, or other government agencies.

Technology Transfer’s efforts may not be the stuff of headlines, but they’ve produced huge dividends for public health. They’ve helped guide FDA researchers through negotiating agreements, to establish collaborations, and to ensure that the tools they use to report, transfer and protect the patents of technologies align with legal and policy requirements.

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