The National Institutes of Health funds what it calls extramural research in a wide variety of fields. Our guest has for many years worked to ensure that small enterprises got their share of the grants. Now she’s the recipient of a Tibbets Award from the Small Business Administration for advancing the Small Business Technology Transfer and Small Business Innovation Research programs. For more, the director of the Office of Clinical Policy and Programs at the FDA., Dr. Jodi Black, joined Federal Drive with Tom Temin.
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Tom Temin: Dr. Black, good to have you on.
Dr. Jodi Black: Hi, thank you. It’s nice to be here.
Tom Temin: Just review for us what the Office of Extramural Research does precisely.
Dr. Jodi Black: NIH is the National Institutes of Health, the principal health research and funding agency of the federal government and its budgets nearly $43 billion. The Office of Extramural Research at NIH provides the corporate framework for NIH research administration, and it provides strategic leadership for setting and implementing the agenda and the policies and processes that govern NIH extramural research. And it’s also responsible for the information technology framework and systems that support the grants enterprise. And while I was there, one of my goals was to scale a product development enabling office that I had started at the Heart, Lung and Blood Institute across the entire NIH.
Tom Temin: And you say when you were there, so you’ve moved on from that program?
Dr. Jodi Black: Yes, I have moved on. I’m now at the Food and Drug Administration.
Tom Temin: Okay, well hearken back to your experience at NIH in that Office of Extramural Research. Tell us the tie in with a small business, small business innovators and technologists. How do they tie in with the extramural research,?
Dr. Jodi Black: The Small Business program is congressionally mandated, it’s money that each of the funding agencies within the federal government have to set aside. They can’t spend it on anything else. And for NIH, it’s about $1.2 billion of non dilutive funding. But that funding is designed to support the riskiest stages of product development. So here the government is providing the funding to reduce the proof of concept stage risk, and help mature technologies for downstream non federal investments. The problem is that until recently, most scientists don’t really understand the product development process or the regulatory requirements or how to talk to investors, they don’t understand intellectual property, or business development processes. So there’s a gap in knowledge, there’s a gap and access to expertise. And in the academic setting, there’s a lack of sufficient pre seed funding to help define those products. And so the developing strategies to help fill those gaps at any federal agency, including NIH, helps those agencies meet their main mission, which is improving the health of the nation for NIH or general societal benefit. So for NIH, the mission is to take fundamental knowledge about the nature and behavior of living systems, and then apply that knowledge to enhance health and lengthen life and reduce the burdens of illness and disability. And the NIH tagline is turning discoveries into help. And so the Small Business Program at NIH helps it meet that goal.
Tom Temin: And how does it do that? You got an award for helping people do that, so this was directing early stage money to small businesses essentially?
Dr. Jodi Black: Yes. And so what it does is the Small Business Program helps to support the translation, or as I like to say that transition of innovative potential products to societal benefit. It’s the main source of non diluted funding at the federal government could help to provide access to resources to mature products, not just write papers and publish them, but actually take the fruition of research and move it into the commercial sector where it does some good. That’s why most scientists get into science.
Tom Temin: So now that you are at the FDA, are you in a position to see things that you might have funded with seed money in developing new technologies, new products at the small business level? Are they then coming through FDA at some point for approval as real products in the real marketplace?
Dr. Jodi Black: So that’s an excellent question. And I’d like to tell you a little bit about some of the programs that I developed and why I decided to move to FDA based on how those programs were working, if that’s okay.
Tom Temin: Yeah, please tell us.
Dr. Jodi Black: So while I was at NIH, I developed an office there that was intended to bring in the kinds of expertise to provide enabling resources to help small business innovators and academic innovators understand how to bring their potential product to the market, to how to transition it from their laboratory bench to the market. As I said earlier, most scientists don’t understand how to do that. And so some of the things that are missing from their knowledge base, whether they’ve spun out a company, or they’re still at the bench in the university, that they don’t understand what needs to be done to meet regulatory requirements. They don’t understand what needs to be done to meet business case requirements, that thinking about meeting those requirements really needs to be done at the earliest stage of product development, this is the most immature stage, it’s when people are still at their lab bench. But they need to design their experiments in a way that meets regulatory and business case requirements. And they’re developed in a way that enables them to develop intellectual property protection that gives them freedom to operate.
Tom Temin: And you did this how?
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Dr. Jodi Black: So I developed programs at NIH and hired in people that are sort of non traditional people for the NIH environment to help provide regulatory mentoring, business development mentoring, intellectual property mentoring — and I set up a program that was designed to help academic innovators in the university setting, understand how to meet all those goals. They’re called proof of concept center programs. One is the NIH Centers for Accelerated Innovations, which focused on the mission of the Heart, Lung and Blood Institute at NIH. And the other is the NIH Research, Evaluation and Commercialization Hub programs. So we had two sets of priorities. One was focusing on people who were in the small business environment, and the other was focusing on innovators who are still in the academic environment. The goal was to teach them how to appropriately develop their products, so that when it was either time to license it or time to spin out of business, the stage was set to do things properly, rather than making very costly mistakes, designing the wrong kinds of experiments that don’t meet downstream requirements. And so those are the kinds of enabling programs I developed at the Heart, Lung and Blood Institute, and then scaled to all of NIH while I’m in the Office of the Director in the Office of Extramural Research to develop an office there called the Small Business, Education and Entrepreneurial Development Office, or SEED, which now works across the entire NIH.
Tom Temin: And give us some examples, anything that sought to at least on its way to fruition.
Dr. Jodi Black: I can give you lots of examples without divulging anything inappropriate. There was an innovator at one of the academic institutions that was being supported through the Proof of Concept Center Program, that was developing a technology that helps greatly accelerate the development of certain cells in your blood that help your blood clot, keep you from bleeding to death, basically. And he became involved in the proof of concept center at his academic institution where he received seed funding, really non hypothesis driven funding that NIH normally doesn’t provide, because it mostly focuses on hypothesis driven work. But the non hypothesis driven seed funding that’s required to do the bench work to define the product. In addition to that money, he received mentoring and access to experts, visits, development processes, regulatory advice from my FDA partners who were involved in these programs, to understand what his next steps should be to sort of develop a company and be successful. That company has since been out in under two years, It normally takes about 8 to 10 years to do the work that because he was in this very focused proof of concept and reprogram, was able to understand how to do that. And he competed for a Small Business Award from the NIH, and he received an award. And so I can tell you that people who participate in these proof of concept center programs at NIH funds have about a 60% success rate when they apply for Small Business Awards. The normal success rate is about 20-22%. It’s a very valuable experience. But it also helps with the original government intentions of thinking about universities as our academic innovation centers, helping them sort of spin out and move out of the lab. Those innovations that the government, the taxpayers are supporting. This actually gets the government what it wants. The innovations move out, they use a small business program to provide non dilutive funding. And it sets the stage for downstream investors to help with getting the product on the market, keeping the business going. That’s economic development, its jobs. It makes everybody happy.
Tom Temin: Sounds like you were pretty excited about that program.
Dr. Jodi Black: Yes, it was a very nice program. I really enjoyed developing it. I worked with some very wonderful people.
Tom Temin: Now some of those same innovators are gonna come through the FDA and say, oh no, it’s Jodi Black again.
Dr. Jodi Black: I have not, I hope they see it as a good thing.
Tom Temin: Dr. Jodi Black is.. well tell us your current title.
Dr. Jodi Black: Director of the Office of Clinical Policy and Programs, that’s in the office of the commissioner at the FDA.
Tom Temin: Thanks so much for joining me.
Dr. Jodi Black: You’re welcome.