Episode 12 | NCI SBIR Innovative Concept Award

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Episode Guests

Monique Pond, Ph.D.

Dr. Monique Pond is a Program Director in the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI). She manages a portfolio of grants and contracts to small businesses developing novel cancer therapeutics, digital health technologies, and therapeutic devices. Dr. Pond leads the Connecting Awardees with Regulatory Experts (CARE) Program and other collaborative initiatives with the FDA to assist small businesses in navigating the regulatory pathway for their technology. She initially joined the NCI SBIR Development Center in 2018 as a Science & Technology Policy Fellow with the American Association for the Advancement of Science.

Prior to joining NCI, Dr. Pond spent several years as a regulatory medical writer and consultant at a small start-up where she provided clients with regulatory support for FDA, EMA, and other country submissions. She was awarded a National Research Council Fellowship at the National Institute of Standards and Technology where her postdoctoral research focused on the development of bioanalytical tools. Dr. Pond earned a Ph.D. in chemistry from Pennsylvania State University and a B.S. in chemistry from the University of Texas at Austin.

William Bozza, Ph.D.

Dr. William Bozza serves as a Program Director, managing a portfolio of oncology startups (SBIR & STTR awardees) to facilitate small businesses in technology commercialization for cancer diagnosis and treatment. Dr. Bozza is currently leading the Center’s efforts on the Small Business Concept Award for early-stage high-risk/high-reward technologies that target rare and pediatric cancers. He is also taking the lead on the Program’s Peer Learning and Networking Webinar Series to help SBIR companies learn from peers and facilitate collaboration.

Programs Mentioned in Episode

Explore some of the topics and programs mentioned in this episode:

• Innovative Concept Award Solicitation
• List of cancers defined as rare from the NIH Genetics and Rare Diseases Information Center. See also: The MyPART (My Pediatric and Adult Rare Tumor) Network
• I-Corps at NIH
• Connecting Awardees with Regulatory Experts (CARE) Program
• Investor Initiatives

Episode Transcript

MONIQUE POND: Hello and welcome to Innovation Lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute’s Small Business Innovation Research or SBIR Development Center. Our podcast hosts interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting edge cancer solutions from lab to market. I’m Monique Pond, a Program Director and Team Lead here at NCI SBIR and I'll be today's host.

Today I've invited Dr. Billy Bozza, a Program Director at NCI SBIR, to provide insights into a unique funding opportunity that our program is currently offering, we call it the NCI SBIR Innovative Concept Award. Listeners will get an overview of the support this award can provide for cancer technology innovators with highly transformative projects that address rare and/or pediatric cancers. Welcome, Billy. 

BILLY BOZZA: Hi, Monique. 

MONIQUE POND: Hi, thanks for joining us again today and I’m excited to talk about this new concept award. Before we get into the details of the concept award itself, maybe we can start by hearing some of the background into the origins of this funding opportunity. 

BILLY BOZZA: Yeah, it's actually an interesting story. So the concept award was designed in response to a recommendation from an external working group that was convened by the NCIB, that working group evaluated the SBIR program as a whole. And actually one of their top recommendations was to create a new funding mechanism that could support early stage innovation projects that are of the high risk, high reward nature that might not have much preliminary data associated with them and which would kind of harm them in a peer review process that's kind of standard towards NIH. So that's how we developed the concept award. And our major goal was to create a pipeline of innovation to make sure we're continually soliciting the top innovative projects. 

So, the second piece to that is we're hoping to address some of our portfolio gaps for rare and pediatric cancer indications. And we have these gaps because it's often quite challenging for companies to commercialize in this space for a number of different reasons, complex regulatory pathways, low population cancer indications. So we're hoping with the funding support from the concept award, we can reduce some of these barriers, allow companies to commercialize in this space and address some of these portfolio gaps. And our big picture goal is to help accelerate these potentially game changer technologies from concept to clinic. 

MONIQUE POND: Great. So you mentioned early stage and just for our listeners here today, do you mind kind of defining a little bit what you're talking about when you say early stage, because I know that that can meet a lot of things to a lot of people? 

BILLY BOZZA: Yeah. So, for the concept award, no preliminary data is required. So, we have been able to and have been successful in funding companies that are at the concept stage. There still needs to be some scientific feasibility associated with the project whether that's, you know, minimal preliminary data or referencing scientific literature, but you can definitely, you know, be successful in competing for this funding mechanism with, you know, very limited preliminary data. And the way I think of it is really whatever data that you typically put together for a strong phase 1 SBIR application are some of the type of activities that can be funded and investigated through the concept award mechanism. 

MONIQUE POND: It's almost a pre-SBIR funding opportunity, if you will. People could potentially take their innovative idea, apply through the concept award, and then have data to go on and be successful, hopefully, and maybe a phase 1, phase 2 SBIR. 

BILLY BOZZA: Yeah, definitely. I like that wording, it's a great way to put it. 

MONIQUE POND: Well, let's talk money now. So what are the funding levels for this opportunity? 

BILLY BOZZA: Yep. So it's a $300,000 contract funding opportunity. Typically we see one year projects funded through this mechanism. Again, preliminary data is not required and at max, when they submit their proposals, they can only include up to one page maximum of preliminary data. So really, you know, offers are completing their critical de-risking aims or objectives through this funding mechanism. Another kind of important thing to note, later stage development will not be supported through this mechanism as well as non-exempt human subject research, those are things that are not considered within scope for the concept award. 

And in terms of timing, one of the things and the cool features of this award mechanism is our goal is to issue all awards within six months or less. So, we think that's really important if, you know, there's a really cool, innovative idea we want to, you know, fund that as quick as possible. And also, we want the whole application and peer review process to be as streamlined as possible. If it's, you know, kind of an innovative idea, but there's not much preliminary data behind it, it can be daunting to put together a full proposal. So, you know, making all of that kind of seamless and efficient is important for, again, soliciting some of the most innovative ideas. 

MONIQUE POND: So, for innovators out there, you talked early stage, no preliminary data are required. What about technology types? Is it open to any technology types or are you focusing just on therapeutics for these rare and pediatric cancers? 

BILLY BOZZA: Let's say it's focused on most technology types. So we have and I would continue to recommend applying if you have a therapeutic, a preventative agent, a device, a diagnostic, digital health technologies, those are all kind of within scope. I think the major driving consideration is does the technology have the ability to change detection, treatment, prevention or care of a rare pediatric cancer indication?

MONIQUE POND: So out-of-the-box, innovative ideas, pretty open to technology type, though it sounds like. 

BILLY BOZZA: Yes. 

MONIQUE POND: So how do entrepreneurs find out if they're eligible to apply for this opportunity? 

BILLY BOZZA: Yeah. So there's a couple of pieces to this. The first question that frequently comes up is how do I know if my cancer indication is rare? So we're leveraging the NCATS Guard website for this, you can find a link for that in the solicitation. It's a very easy web page to navigate, you can type in your disease indication if it pops up on the list, it's considered rare. Important to note, our definition of -- our definition of rare is pretty broad, things like pancreatic cancer is considered rare. So, for pancreatic cancer, there's about 60,000 new cases of pancreatic cancer in the US per year, so not typically considered rare, but within scope for concept award. 

We are also encouraging a tough to treat, low survival cancer indications, that's something we always kind of recommend. You know and the simplest and best way to find out if you're eligible is to submit a white paper. A white Paper is a short two to three page summary of your technology. If you check out the solicitation, it has guidance on what type of information to include in the white paper. It's important to include enough detail to allow for a meaningful white paper review. And it's interesting, that white paper review it's organized internally within the NIH. It's something that I think it's really cool and a nice win for NIH. About each fiscal year, we have about 70 different NIH White Paper Reviewers that they were able to recruit and onboard for this internal review process. 

And again, the major goal is to just decide whether or not to encourage the offerer to submit a full proposal. And all companies will receive written feedback even if the answer is yes or no to a full proposal, though they'll receive some written feedback as to why that determination was made. 

MONIQUE POND: Wow, that's great and quite different from the grant side of things. So what if someone's listening today, let's say they didn't learn about the white paper in time, are they still eligible to apply or do they need to wait until the next year and the next opportunity? 

BILLY BOZZA: Yeah. So they can still apply. You know, we highly, highly encourage the white paper review process. You know, that's the best way to kind of get feedback from NCI, if it's within scope of things that we want to receive and allows some information on ways to kind of enhance a full proposal. So I would strongly recommend submitting the white paper process. 

MONIQUE POND: You mentioned it was only two to three pages, that is a nice plus. 

BILLY BOZZA: Yes.

MONIQUE POND: Not many things are that short for applications in the government.

BILLY BOZZA: Yeah, that's the goal is to simplify things on both sides. One, on the offer side to make sure they don't waste time putting together a full proposal that might not be responsive. And two, for evaluating early stage innovation, we kind of want to create a tailored and, you know, smaller peer review process, so the white paper allows us to do that. So that's why we kind of, you know, really important and highlight the need to take part in the white paper process. 

MONIQUE POND: Awesome. So for those listening in, definitely do that white paper, it sounds like it could save you some time and you mentioned getting feedback as well. Alright, so since this does seem to be a pretty high priority program for NCI SBIR, are there other additional support mechanisms that you'd recommend for concept awardees or people interested in the concept? 

BILLY BOZZA: Yeah, great question. Thanks for asking that, Monique. So all concept awardees are expected to enroll in the NIH ICORE Program and we provide supplemental funds for companies to take part in the ICORE Program. And what is -- so what is ICORE? It's an entrepreneurial immersion program where companies can refine their business proposition. So, it's an excellent resource and opportunity. So, companies form three member teams and go out and conduct over 100 interviews over an eight week period of time. So again, it really allows them to refine their business proposition. 

Second piece of support mechanisms that we provide for concept award is, and this is relatively recent, so now all concept awardees that successfully complete their original aims or objectives through the original $300,000 funding opportunity are able to submit a transition to phase 2 proposal for continuing the program and the project, and these are higher dollar award size, so $3 million for phase 2 awards and $3.5 million for fast track awards. And so, this is the first opportunity for this will be coming in fall. So companies will be invited to submit a transition to phase 2 proposal in fall. And we're planning to have an informational webinar to kind of go over a little bit more detail of this in late summer. 

And the third piece of this, as an SBIR awardee, they're able to leverage a lot of our additional non-funding resources. So we have a ton of great programs. I'll just highlight two quick ones. CARE, that allows our companies to get early access to FDA regulators. And our Investor Initiatives Program, it allows companies to go out and pitch their technology to help try and raise additional funding support. 

MONIQUE POND: That's awesome. So not R&D funding, but other support that's obviously very important to get these technologies to the clinic and to helping patients. So, as far as key dates, people should be aware of or timing, where can they find this information for this upcoming solicitation? 

BILLY BOZZA: Yeah, the solicitation is currently out and open, you can find that on our website. And in terms of upcoming deadlines, our first is our white paper deadline, that's June 5th, and our full proposal receipt deadline is September 23rd. 

MONIQUE POND: OK, so plenty of time for people to submit the white paper, get the feedback from NCI reviewers, and then make changes and develop full proposal. Thanks, Billy for speaking with us today. Sounds like a really unique funding opportunity, great opportunity for your bio -- an early stage biotech researcher, perhaps working in rare pediatric cancers and you have some game changing ideas to address these cancers. 

BILLY BOZZA: Thanks so much for having me, Monique, had a great time talking about concept award. 

MONIQUE POND: Great. Wow, looking forward to a lot of interesting new ideas. And if you're out there, please don't forget to check out our website sbir.cancer.gov for the latest funding opportunities and commercialization resources to support your journey from lab to market. This was Monique Pond from NCI SBIR. Please join us again for the next installment of NCI SBIR Innovation Lab and subscribe today, wherever you listen. 

If you have questions about cancer or comments about this podcast, you can e-mail us at nciinfo@nih.gov or call us at 800-422-6237, and please be sure to mention Innovation Lab in your query. We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening, everyone.