In this episode, you will get advice from two NCI SBIR-funded startups on how to write a good specific aims page on your application. Senior Vice President of Radiant Digital Jeffery McLaughlin and Co-Founder and CEO of DoseOptics William Ware will share how they successfully put together this key application component.

Listen to this podcast to hear:

·       Highlighting significance and clinical impact in your specific aims page

·       How to provide sufficient detail and quantitative milestones

·       Specific features for devices and digital health

·       Considerations for Fast-Track and Phase II SBIR/STTR applications

 

Podcast Guest Speakers: 

 

Name

Bios

William Bozza, PhD
Program Director
SBIR Development Center
National Cancer Institute

William Bozza, PhD 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 are targeting 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.

 

 

Jeffrey McLaughlin

Senior Vice President

Radiant Digital

Jeffery McLaughlin is a highly accomplished professional with over 25 years of experience encompassing organizational leadership, customer and user experience, digital media, human-centered design, and software development.

 

Mr. McLaughlin is recognized for his ability to drive innovation through human-centered design thinking, customer discovery, and rigorous engineering. His research endeavors have yielded impactful projects in domains such as worker safety, trauma recovery, cancer survivorship, medication adherence, chronic disease management and more. These endeavors reflect his commitment to improving the lives of individuals through outcome-focused technology solutions.

 

In his role as Senior Vice President of Services and Solutions at Radiant Digital, Mr. McLaughlin provides strategic leadership across every facet of the company’s business, including service line definition, technology development, delivery, and business growth. Under his guidance, Radiant Digital has consistently produced award-winning digital experience initiatives for Federal, State, and commercial clients.

 

 

William Ware,MS

co-founder and CEO

DoseOptics

William Ware is the co-founder and CEO of DoseOptics, LLC. The company is developing an imaging technology that will allow, for the first time, radiation therapy to be visualized. Treatments will be easily and routinely verifiable directly on patients thereby minimizing delivery errors and improving outcomes. William graduated with a Master of Science in Chemical Engineering from Darthmouth Thayer School of Engineering, from where he spun out the company’s technology based on the work of President and Co-founder Prof. Brian Pogue.

Transcript: 

             [music]

 

             BILLY BOZZA:  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, 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 Billy Bozza, a program director at NCI SBIR and today's host.

 

             In the last episode, you heard from an SBIR-funded therapeutics company and a diagnostics company on tips to write a good Specific Aims page for your application. Today you will hear advice from a digital health company and a device company.

 

             Up first, we have a digital health technology developer Radiant Digital. Senior Vice President Jeffrey McLaughlin will share considerations for fast track applications and digital health startups.

 

             JEFFREY MCLAUGHLIN:     Hi there, I'm Jeffrey McLaughlin. I'm the Vice President of Services and Solutions at Radiant Digital, also known as Radiant Creative Group. And we've competed in the SBIR and STTR program for around 15 years. We've funded multiple Phase 1, Phase 2, and Fast Track projects, and we've done so in collaboration with some top tier institutions like MD Anderson Cancer Center, the University of Texas, and Children's Hospital of Philadelphia.

 

             So today, I'm going to be talking to you about how to write a good Specific Aims page. Throughout the discussion today, I'll be referring to one particular project in our portfolio, a program called Stem-Powerment [phonetic].

 

             This is an online, gamified social intervention for adolescents and young adults that have undergone stem cell transplant therapy and are facing a protracted and challenging recovery period. So this program was developed in collaboration with MD Anderson Cancer Center and UMBC, and it was funded by NCI.

 

             Is it important to highlight significance in clinical impact and how did you define your problem statement?

 

             So let me first say that emphatically yes, significance is often the first thing you'll see on a good Specific Aims page. If you look at this like storytelling, significance functions as the core conflict that drives your narrative throughout your research proposal. And impact is the hero that you hope emerges from the narrative.

 

             So I think impact is particularly interesting in the SBIR world, the commercialization drivers in SBIR make it well suited to diffusion of innovation models, for instance, which force you to think at a systems level and consider community and organizational and individual factors that might influence impact.

 

             So in our Stem-Powerment project, we defined our problem statement from the top down. So, again, this is a digital intervention for AYAs who have undergone stem cell transplant therapy.

 

             So we first start with the risks and the impact of stem cell transplant therapy on patients. And then we identified the specific behavioral gaps that we know exists today, and these are things like poor medication adherence and poor hydration management.

 

             Linked those gaps to long-term outcomes that those patients may experience, if those risks aren't managed effectively, and then finally identified the critical factors specific to our population, AYAs that make this protracted recovery period especially challenging.

 

             And those are things like social isolation, maybe returning to parent care after being independent, managing a very complex medication regimen, those sorts of things.

 

             Next question, what milestones specific for digital health technologies are essential for a Phase 1 application?

 

             So I look at a Phase 1 as a de-risking project. You want to look at both the technical and non-technical aspects of the work that you're doing and establish feasibility, that's the spirit of a Phase 1.

 

             So from a non-technical perspective, I would argue that digital health is always going to be user-facing in some way. In many ways it can be highly personal for the users that are impacted by the work, so, some measure of user acceptance, some measure of the impact of the technology or the solution on, on the users that are actually going to be adopting it.

 

             There are a number of different frameworks for examining this, and you can look at constructs like usability, subjective appeal, engagement, those sorts of things. But fundamentally you want to make sure that by the end of your Phase 1, you can demonstrate that your users will actually adopt the technology that you're proposing.

 

             The other layer to the non-technical feasibility is really understanding how your solution fits in with the broader ecosystem of digital health solutions. So that's better quantifying or qualifying the need, understanding your stakeholder groups and your beneficiaries, buyers and partners, those sorts of things, and further refining your unique value propositions.

 

             This may not translate to specific milestones, but if it does, it would look something like milestones that you would try to achieve using Steve Blank's Startup Method, for instance, where you want to conduct a certain number of user interviews with key stakeholders and integrate those findings into your approach.

 

             From a technical perspective, you want to demonstrate basic feasibility of the supporting technology or the method that you're implementing, and you want to eliminate the known unknowns related to dependencies or upstream integration, or what have you.

 

             Now, this can mean developing a prototype, it can mean having conversations or building support at an institution, what it translates into -- in terms of milestones, again, is going to be dependent on your, your project, but de-risking the project, that's what it's all about.

 

             On to our next question, how did you make your aims quantitative? In Stem-Powerment Phase 1, we wanted to move beyond measuring basic usability as an endpoint. We were working with an AYA population that was technologically savvy and we felt like usability was table stakes, maybe too low of a bar.

 

             So what we did was adopt a popular technology acceptance model that's typically used in enterprise IT, the TAM, this was developed by Venkatesh and Davis and others. It incorporates a number of useful constructs, perceived usefulness, ease of use, subjective norms, those sorts of things, it also lends itself well to adaptation.

 

             So practically, what the TAM gave us was a collection of scorable measures that allowed us to set an overall cutoff score as our primary benchmark for demonstrating user acceptance and feasibility. We also layered in some intrinsic system measures, system performance, reliability, those sorts of things.

 

             And then within the project we iterated through several approaches to the intervention, integrating feedback from our users and incorporating it, so as to increase the likelihood of achieving that benchmark that we had established.

 

             Next question, can you highlight a critical and unique aspect of your Specific Aims page?

 

             So first of all, I have to give credit to my collaborators. This was not my Specific Aims page, it was our Specific Aims. So credit goes to Doctor Susan Peterson and Doctor Martha Atkins at MD Anderson in particular.

 

             One thing about the Stem-Powerment specific aims is that it was a breakthrough for me in terms of understanding grantsmanship, and it's essentially a narrative structure that looks a bit like an hourglass.

 

             So you start from a broad problem, you narrow that down to a specific population, and a specific solution that you're proposing for that population, you relate that solution to a set of expected outcomes, and then you describe how you're going to scale beyond this single project.

 

             So the solution has to be broader than just what I'm going to do in this Phase 1. And then you close with the aims themselves, which are succinct description of the activities that you're proposing to complete during the project.

 

             Seems simple, but it is one of the most challenging documents to produce in a grant application. Often times producing specific aims is a highly iterative process. You start out with an initial draft, then you write your research strategy, and you go back to your specific aims at multiple times throughout the project, but it's hugely important. It's one of the first things that a reviewer is going to typically look at and it should be a clean, crisp, clear encapsulation of your project.

 

             And the final question, how did you organize your Specific Aims for a Fast Track application? The program I've been describing thus far, Stem-Powerment, was not in fact a Fast Track, it was a Phase 1 to Phase 2, but I'll share my experience with other Fast Tracks that I've worked on.

 

             It's a challenging application. You have to be able to make some pretty confident and bold claims about what you expect to find in your Phase 1, to justify that immediate transition to Phase 2 without a follow on applications. What that means is that that connection between your Phase 1 and your Phase 2 is always going to be the weakest point in the application.

 

             There are several tactics you can use to mitigate that Phase 1 to Phase 2 transition risk. One is to introduce the background research early and often. So in your Specific Aims page, you want to describe the work that's been done today and why you believe that work justifies a fast track approach, and then the second tactic is to very clearly link the two phases.

 

             So have an output from Phase 1 feeding into an input in Phase 2 in your aims. That means being able to describe an aim that accommodates unexpected findings from your Phase 1 immediately in your Phase 2.

 

             [music]

 

             BILLY BOZZA:  Presenting next is William Ware, co-founder and CEO of DoseOptics, an NCI SBIR-funded device company.

 

             WILLIAM WARE: Hi, my name is Bill Ware. I am the co-founder and CEO of DoseOptics. And I'm going to talk to you about how to write a good Specific Aims page.

 

             Just a little context about who we are and what we do. We make imaging systems, cameras that image radiation therapy. We are a company that was founded with a successful Phase 1 application and we've had multiple Phase 2s, both through Fast Track and direct to Phase 2 and, and, and in a more, more recent phase, a new Phase 1.

 

             So, the first question to answer is, what steps did we take to start organizing and drafting your Specific Aims page? And this, uh, there are really four key things that you need to address here.

 

             You know, obviously you found something that has some sort of commercial relevance that needs to be described: why this is important? What's the unmet need that this technology addresses? Why you, why you'll be successful? What, what, what kind of team do you have or what kind of advantages do you have that you should be the one to be doing this work? And then what does the plan look like? Which really is, you know, the aims of, of the, of the page.

 

             Additionally, once you've, once you sort of drafted this and get an idea, find the government agency that's looking to fund this, this sort of research. Obviously this is a NCI webinar here, so you've obviously made it to, to this part, but reach out and find the project manager and they can help with that and, and, and be -- They're really helpful to review your, your aims and, and what you're trying to do.

 

             How were we able to sufficiently detail our Specific Aims page and still meet the, the one page limit? And this is, this is important, it's -- you really need to be concise, you've got one page and you need to address these questions.

 

             So I'm going to use an example of, of our -- what we did on our latest Phase 1, the commercial relevance. This is -- We're developing a camera for a new paradigm in radiation therapy called Flash. And so that's the, that's the commercial relevance.

 

             The second piece is the unmet need and that's verbatim, there is a, however, a lack of devices capable of monitoring the beam output and location on a pulse to pulse basis. So there's our, there's our unmet need.

 

             Then we talked about in the third sentence, following the success of our imaging cameras, conventional radiotherapy currently deployed in beta sites. So we, we sort of toot our own horn and say, “Hey, we've done this before and we've done, we've built cameras before, so we can do this.”

 

             And then, and then we hint at our plan. You know, we want to extend the capabilities of our camera systems for, for flash imaging in patients and for beam quality assurance.

 

             And that's our first paragraph and we've ticked off all the boxes. So that takes up about, you know, an eighth of the page or so, in our case, we've got another half page or so to, to, to, to flush those out in a little more detail. And then at the bottom, you know, third of the page, we go through the three aims of the proposal.

 

             What milestones specific for device technologies are essential to be included in a Phase 1 application? So in the Phase 1, you're really trying to show feasibility and show that you can meet, address an unmet need.

 

             You know, these Phase Ones are really, you can think of it as an alpha, alpha prototype. And in all, you know, in sort of -- in all sort of product development, especially devices, it's really about prototype, test, and iterate: wash, rinse and repeat.

 

             And, and so this -- For our Phase 1, we consider it, it's our -- sort of an alpha prototype of, of this device, what do we need to get done and how are we going to test it?

 

             And so ours is, our three aims are broken down into a hardware aim. Our first aim is all about hardware and getting the hardware right. Aim two is about the software, to integrate and do image processing for us. And then aim three is how we're going to test it.

 

             The next question is how, how do we make our aims quantitative? So, you know, our aims are, uh, pretty straightforward in terms of hardware, software, and how we're going to test it, but the, the quantitative aims need to address sort of the unmet need.

 

             And so it's either for, for some cases, some people, it's, you know, you're developing something better than existing, so you've got a benchmark that you need to meet, and, and you really want to make these aims quantitative.

 

             In our case, we are -- we need to develop a camera for a new type of radio, radiotherapy, and so that dictates sort of a lot of the metrics that we need to meet. We need to -- We have a speed of camera, imaging, in terms of frames per second, and signal to noise ratio, and it's got to be -- the resolution requirements are there as well.

 

             And then from a software perspective, we need to be able to process, an image process within a certain amount of time because it's, it's really a high speed process that we're trying to capture here. And then we're going to test it using, using phantoms.

 

             This is a Phase 1, you know, it's a limited budget. We're, we're not going to put patients in on this particular phase, once you get started getting into patients, it becomes very expensive.

 

             What are some unique considerations for a Phase 2 Specific Aims page?

 

             So, this, this focus is really around a Phase 1 application, but it's important to consider what the Phase 2 might look like. You want to plan for, for success, you wouldn't be doing this if you didn't think you would be successful. So in part of that planning, you should consider what's the, what's the next prototype look like? What's the next beta version look like?

 

             And, and, you know, this should lead into that, the Phase 2 should lead into that, too. So the Phase 1 is really about feasibility, proving that it works, your image on phantoms, or, or a very small number of patients, and you just, you're just showing that it, that it's work, it works.

 

             In Phase 2, it's more of a refined prototype, it's a more of a beta prototype. It's a net, you're making it smaller, faster, cheaper, closer to a commercially viable device. And then you test on it, on like, an order of magnitude more patients. If we did, if you did one in the, in the alpha, you probably want to do 10. If you did 10 in the alpha, in Phase 1, you want to do a 100 or so in, in the Phase 2.

 

             But that all depends on the project and of course the budget.

 

             Can we highlight a critical and unique aspect of your Specific Aims page? So our, our -- We're, we're starting from an already designed and built camera. So we've got a platform that we're building upon to, to do sort of this next generation type development.

 

             And, so that's kind of unique for this, but, but we did start with a, with a, you know, a Greenfield sort of Phase 1 that was built upon some university research proof of concept type studies and, you know, you need -- In my opinion, you've got to have something to, to, to show credibility, to show that you've done at least the -- some basic amount of work that provides credence to the, the -- what you're proposing that you think you, that you'll be able to do what you think you can do, what you're going to propose to do?

 

             And with that, that's it. Thank you very much. Good luck.

 

             BILLY BOZZA:  Thanks so much, Jeffrey and William for speaking with us today. As always, don't forget to check our website, sbir.cancer.gov, for the latest funding opportunities and commercialization resources to support your journey from lab to market.

 

             This was Billy Bozza 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, e-mail us at [email protected] 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.

 

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