10 Insider Tips for SBIR Grants
Transcript from Live Webinar on 2 June 2020 by Dr. Pam Lucchesi Watch the Webinar
Today’s webinar is presented by a very special guest, Dr. Lucchesi, joining us from the East Coast. Dr. Lucchesi received her PhD in Biomedical Sciences from the University of Massachusetts Medical School and is an elected fellow of the American Heart Association and the American Physiological Society.
She has a 30-year track record of continuous extramural funding related to cardiovascular disease and has mentored numerous fellows, junior faculty, and small business owners. Thank you so much for being here today, Dr. Lucchesi and I’m going to turn over the presentation to you.
Thank you very much. And I have to tell you how delighted I am to be here. As I was speaking with your host earlier, this is not the type of training that I received when I worked in my graduate work and my postdoctoral work because in the late 80s and early 90s, we were still at that end phase of discovery research. And so we were doing science for science’s sake and trying to think about going to pharma or starting your own business was almost like selling your soul to the devil.
But now, I think we have shifted our focus to where it should be which is doing research and starting companies whose ultimate goal is to improve the health care and the lives of our community. So today, we are going to be talking about how to use the small business innovative research (SBIR) grant mechanism as a way to achieve that ultimate goal of improving health care for everyone in our community or improving quality of life.
So, we’re going to start with an overview in the next few slides about the most important tip is at the very beginning, before you even start registering your business and preparing your application is to really find the best fit for your project. Whether it’s a device, a drug, a therapeutic, a new platform.
You have to begin to understand how the different institutions and agencies, what their funding mechanisms are, what money they actually commit to that, those funding mechanisms. And actually finding what the right funding level is. And as we go through the talk, we’ll hit each one of these areas.
The two major places for small businesses that deal with, in general, health sciences and biomedical research are the National Institutes of Health (NIH) and the National Science Foundation (NSF). We’ll see in a few moments how some other agencies also have funding mechanism for the side but they are a little bit more tricky than these two agencies.
So, when you think of the NIH, you really think about I want to either prevent disease, take people that are unhealthy and make them healthy or cure disease or at least increase the quality and quantity of life. So, again, fundamental is to seek application of your knowledge to enhance health, lengthen life and reduce illness and disability.
The NSF, on the other hand, does not like it when you use the word disease in your applications. What they are looking for is technology. And that technology is actually based in discoveries and either fundamental science, engineering, physics, mathematics. And what they are looking for are the big things. How will this new technology lead to changes in improving our society? So I’ve worked with people that were working with the particle collider [inaudible 00:04:20] and obviously, they were at the NSF level rather than the NIH level.
The due dates are a little different now. They used to be more compatible but now, we still see that for most regular grants that there are three funding opportunity dates at the NIH, the January 5th, April 5th, September 5th. With the current COVID-19 crisis, there has been a little bit of wriggle room with some of these regular due dates. So, they are promising you that you if you put your grant in two weeks late, that it would still get reviewed. But they’re hedging the bet and saying, “We’ll do everything we possibly can.”
So I usually encourage my collaborators to put those grants in on time if they can or at least talk to their program official and give them a heads up that their grant might be a little bit late.
The NSF this year has actually taken that into account and said rather than giving you a hard due date, we’re going to give you a window of opportunity. So they have two funding dates from June through September and then September through December. So at any phase during that time, you can submit your application.
The one thing I want to point out to you on this slide is the actual amount of funding. So when you look at where you’re going to put your grant, you have to also consider how much funding is available for SBIR and STTR type grants.
And as you can see here, the NIH has a lot more money than NSF. So if you are in a biomedical field where you can have a direct health care application, the NIH has about three times more money over all than the NSF. The NSF, which is also interesting to me and I actually love this about them, is they have a project pitch that you first have to give to the program official or the program manager, that gives them an elevator talk of the objectives, the technical innovation as well as some of the technical risks.
The NIH does not require that but as you’ll see in a moment, I think that’s a really good idea because you want to have an idea from the institute whether your project is going to be competitive and based on their experience and their funding portfolio, how do you choose? And so we’ll see how the project pitch that is mandated in itself can also be applied in the NIH.
All of the links that I have in this presentation you should be able to access. And what I found that when you go through the government websites because it’s the government and it’s full of bureaucracy, it can take you a long time to find the right information. So what I’ve tried to do in this talk is give you the websites that you need to go to that will provide that information.
The NIH tends to have a bigger budget for their phase II grants. They can go to five to six million, even though they say in their instructions it’s 1.5 to two. They have a phase II, a direct to phase II and a fast track and we’ll go over those different mechanisms. Whereas in the NSF, you put in your phase I, if successful, then you apply for the phase II.
This is another way to break down what these institutes are looking for. So the NSF really likes that platform technology. You can get a great, impressive business plan, the NSF prefers it. But the NIH is like, “No, we really don’t want that kind of technology. We want that individual product or device. A drug, a therapeutic, stem cells.” And what that focus is, we need to have data to advance your product or service toward the market.
And the methods that you employ to collect those data, i.e. innovative research or coming up with milestones that you have to achieve to make your Go / No Go funding decisions. For investigator-defined projects, which are mostly for the SBIRs and the STTRs, it’s sort of your job to target the funding agencies that have missions and interests that are relevant to your product. So that is the vast majority of the SBIR and STTRs for the NIH and the NSF.
We’ll see that the DoD who has a lot of money for small businesses, it’s really the agencies defining the projects. So you’re responding to them to say, “Okay, what does the program need? Not what do I have in my portfolio.” So if you can align your product with the agency’s needs, then that is a viable place.
So, a good example of this would be if you were thinking of nano particle delivery of a drug to treat cancer. The NSF would love to fund you to develop a nano particle delivery system or platform that could maybe be used to start targeting to different types of cells in the body or different tissues.
The NIH would say, “Okay, I want you to take that nano particle platform and then show me how you can use that to deliver say a cancer therapeutic to a solid tumor or maybe a drug that fights atherosclerosis that can be targeted directly to the atherosclerotic plaque”. So there is a little bit of nuance here but when in doubt, the best thing to do is to ask your program official if your product is going to fit in their portfolio.
Now, there are two types of application process for both the NIH and the NSF. There is the Omnibus Parent solicitations which are pretty much … That’s what we talk about being investigator-initiated. That funding mechanism is called the parent either for a phase I, R41 or R43. And for a phase II, an R42 or R44. There is just a generic announcement saying, “We want grant applications from small businesses.”
On top of that, they also publish two things. So they publish a program descriptions and research. So you can go to this website that I have up here and it will tell you for each institute within the NIH the types of things and the description of their research topics that they cover in their particular institute.
Now, not all institutes are the same. So in that guide, it will also tell you any funding restriction. So for example, some institutes will allow clinical trials in phase I and phase II, some won’t. So that’s where your first stop is to just look at their overall topic list and portfolio.
The other nice thing about these documents is that it provides the contact list for the program officials and staff for each of the institutes. And you will soon learn that your program official can be your best friend. So, cultivating that relationship will become very important.
So this is the generic place and then I also gave you the link for the NSF. The NSF has updated theirs to the current fiscal year of 2020. The NIH is lagging behind. So if you see that and say, “Oh, it’s going to expire in June,” don’t freak out. They’re automatically extending these parent solicitations. They just haven’t got around to it yet.
So they are still accepting them. It’s just that this has not yet been updated. And by and large, from year to year, the program descriptions really don’t change too much. They may add a couple of new topics, based on any emerging health care needs.
The other thing that’s fun in this website is you can look for topics where you can exceed the budget limitation. So pretty much any device research or late-term platforms that need a lot of R&D from an engineering perspective, you very easily can get a waiver for some of these hard caps on funding. You just have to know who to call and what things have been tapped to have a budget waiver.
I was on a conference call with a program official last week with one of our clients. And he was like, “Yeah, we’ve once funded a phase I for $6 million.” And I was a little shocked to hear that since it says that the funding cap is 250,000. But I really think it depends on the project.
The other type of application process or funding mechanism from both the NIH and the NSF are what they call focus solicitations. These are calls for research that they are looking for a specific topic. And this is a very nice website to go to. It took me about two days to find it. But once I did, it has a lot of information.
So what I just did here is to provide you a sample of some of the list of topics. So what you can do here from the side is say, “Okay, what’s open now? What’s coming down the future that isn’t open?” And then it just lists things. In this particular case did the Department of Health and Human Services (DHHS) but you could do the Department of Defense (DOD), the Department of Energy (DOE), the CDC.
And then what it tells you is the agency, the program, when the announcement was released, when is the very first open date and then here, you just hover over the button and it will tell you all of the upcoming due dates for that particular mechanism.
And then here, it shows you this is the last date, at least for now, that they will be accepting applications. So this close date can run anywhere from June of 2020 to December in 2021. So the ones I gave you were just a sampling, going anything from novel nuclear gas and sequencing technology to looking for cell replacement, therapies for type I diabetes as well as alcohol use disorder.
So there is a very broad range of topics that each institute sets their own agenda for the year, saying, “These are the types of grants we really need to fund. So this is on top of those parent applications.
Now, after you have figured out what agency I should go to, the Health and Human Services, NSF, NASA, DOD, the next thing is what kind of grant do I put in? Do I do a small business grant or do I do a tech transfer grant? And this is a nice table that shows you the differences between these types of funding mechanisms.
So for an SBIR, you can do it all by yourself or you can have an academic partner or another partner in the small business world or contract research organizations but it’s not required. In the tech transfer grant, you actually have to have a non-profit research institution partner. By and large in my experience, these types of grants are usually started by someone in an academic setting that wants to branch out and start their own company and they need to do this tech transfer from the university or the medical school into the public sector.
So in an SBIR, the employment, 50%, must be with the small business whereas the PI on the STTR can be employed either at the research institute. And notice what I say here, or a small business. I’ve seen multiple STTRs where the PI is both the PI at the research institute and the CEO of the small business. It makes the reviewers annoyed because they’re not clear what this really is. So I encourage you, for an STTR, is to make the PI of the research institute to be different than the person who is running the small business. Even if it’s more virtual and it’s not quite as hit the ground running, on paper, it tends to look better if it’s not one and the same.
Now, this is something that the NIH administrative staff is beginning to take a closer look at which is how much can you subcontract out to another company without physically doing it in your own business space? So the SBIR says you can contract up to a third for phase I and 50% for phase II. And it’s sort of similar with the STTR. So it’s not that you have to be 51% or 49%. But if you can’t show that your business is involved in the design and not necessarily the execution of the experimental plan but the design, the data collection, the analysis, the interpretation of data and how to move forward with the research, then you can get in trouble.
I’ve heard a lot of other consultants say that you have to be really, really careful of this. I’ve used it as a guideline. So if I work with someone who is doing all in silico drug structure activity relationship and that is going to partner with people to use those drugs that he’s making in cells, small animals, large animals, that’s completely fine because a large part of that project is still being done by the company or by the PI in a research institute.
As you can see here, the program size is about … I’m not really great at math but it’s looking to me like eight times more for the SBIR versus the STTR. So keep that in mind. And then also, for venture capital ownership, some agencies will allow it for an SBIR but it’s not allowed at all for STTRs.
For SBIRs, we have 11 agencies at the NIH and again, the total budget’s around three billion. Only five agencies actually allowed for these STTRs and as you can see, the total extramural R&D budget is a lot smaller. If you look at this pie graph, what you’ll notice is that look at all these other places and compare it to Health and Human Services, NSF. The DoD has a very large pocket of money. And one of the reasons for this is that Congress cannot, I don’t know if divert is the right word, but certainly, they cannot dictate funding topics or areas of research to the Health and Human Services and the NSF, the Department of Energy and NASA. It’s sort of the illegal thing to do.
But what we do see is a lot of Congressmen have their pet projects and they can allocate resources or fight for resources to go to the Department of Defense. So if you look at the Department of Defense funding topics, sometimes, you get a little bit confused. So they have done research with congenital heart disease, autism, breast cancer. So usually, when you think DoD, oh my God, it has to be completely related to soldiers and the military and improving some aspect of either how they do their military or how to treat them when they don’t do it well.
But, you would be surprised. So I would encourage you, the DoD does … You can go to their site and they have a big list of topics. So it’s a little bit interesting and as you can see, they do many more contracts versus grants. So they decide, “Okay, I want a grant that’s going to improve, I don’t know, thrombosis. Or it’s going to improve the treatment of adults with congenital heart disease.”
So they have very specific funding guidelines and much more restrictions on what you can and can’t do than the granting mechanisms by the other institutes.
Okay, now that we’ve talked about you found the right institute, now you got to figure out, what kind of an award am I going to be competing for? And it used to be simple, you did a phase I, then after you did your phase I and you were successful, you competed for a phase II. The phase II was longer and more money. And then from there, you were going to go either hopefully to be bought out or start licensing or start marketing.
The NIH realized that this very short window is not how you actually bring a product to market. So several institutes now have what they call a phase IIB award which is crossing that valley of death which really is, “I have a product ready to go, how do I bring it to market?” And they recognized that that particular question and how to answer it takes a while. And it also helps things like how do I validate my technology and make clinical translation?
During this time, they help you, actually, secure substantial third party investor funds. They give your $4 million over three years. And at the end of this, the phase III trials, which the NIH is saying, “At this point, we’ve got you ready, you’re now ready to go on your own. You’re going to bring this to market and really do the phase III clinical trials that you need to establish your efficacy and your market.” So by this point, they would like to have you have the majority of your funding, if not all of it, from non-SBIR funding mechanism.
So this is the overall path. But now we’ve done some cool things on top of the phase I, phase II. So some institutes, not all, have what they call as a fast track and we’ll get into that more in a little bit but what you do is you submit both the phase I portion and the phase II together. So usually here, in this particular fast track, your phase I is pretty much done and you need just a few more things.
For normal phase Is, this is your great idea, high risk, high rewards, significant impact, proof of concept application. I still say this mechanism is the last place in the Health and Human Services that a good idea can still get funded without a lot of data. And as you see, it’s not meant to be a long-term grant but it’s just to get you to your minimum viable product. Can you develop a prototype device, a lead compound that you can then in phase II really bring it up into your R&D, get your commercialization plan together and give you enough data to bring your product to the next phase.
So, if you see here, these are standard awards, what they call hard caps. But, with these waivers, you can see that you can go from 1.68 all the way to two and in the cancer institute, you can go even higher in other institutes. So don’t think, when you see the funding or budgetary limitations, that they are set in stone. This is where your program official can help you navigate through this process.
Which brings me to my favorite subject which is know your program officer. If I give you any … If you remember anything today from this webinar, please remember this because this really can help you in tremendous ways be able to determine whether or not your project is going to move forward and be viable. The first thing that we have to remember is that the program official, each program official in each institute, sort of sets a portfolio for the types of topics they would like to see.
And if your project fits in their portfolio, that’s a huge plus because if you get a good score, that program official is going to go to the next step, to council, and actually make funding recommendations. So those two things go hand in hand.
What you can get from your program official is a little bit of things like the knowledge of the competition. So, if you’re putting in a grant for heart failure bio markers and your program official tells you that, “Oh, last year, there were 20 applications for this and we funded five,” it may be that your project might not fit in that cycle or might need to be modified so it would be more competitive at the council level or at the institutional level.
You can also talk to them about what type of mechanism that you think you should apply for. So you can talk about phase I, should I go direct to phase II, skipping phase I? Should I do a fast track? And they usually give you very good advice on where your project fits at these different phases or levels.
And the program officials that I’ve been privileged to work with have really given some valuable advice to our PIs and our clients. And they are very willing to discuss your work with you and if they don’t think your particular project is a good fit for them, they usually will recommend that you try another institute because they all hang out together and they all know what each one is looking for.
So, my advice to you is that you send them an introductory email and ask that you would like to set a time to meet with them. I’ve done them both, by phone or by video conferencing. The video conferencing by far is the better way to go because you actually get to see the person and their body language. So I was on one list week and we could tell that the program official was getting excited because the project that was being pitched was a little different than he had seen before. And he liked the idea of this product being in his portfolio.
So, we could just tell by his body language and his smiles and whatever that he was really into it. So I do like the video conferencing because it gives you that opportunity. Keep it short and sweet. So no more than 30 minutes for the entire process. I would say five slides, no more. Very high level, why you’re doing it, what you’re going to do, how are you different than the competition. What impact, what target audience you’re reaching. And then a very brief overview of how you’re going to do your research plan.
The other thing is if he or she gets to know you, they’re going to start looking for your application. So after you submit your grant, you go through study section and you get a score, you get the score, you get the reviewer’s evaluation and then you call your program official and go, “I need a little help interpreting the score in terms of where am I going to be?”
A program official cannot say, “Yes, that grant is going to get funded.” They would be fired if they did that. But what they could do is say things like, “Wow, this is really exciting and you got an outstanding score. Wow, this score is very competitive and close but I just don’t know.” Or, “Oh, you’ve got some good reviews but you may have to consider re-submitting.” Or if you didn’t get discussed and you got eights and nines, which these study sections tend to use the whole range, the program official is going to give you good advice and say, “You know what? I think even if you revise this, I don’t think it’s going to be competitive.”
That’s really good to hear when you’re in a phase I or as you’re just starting out because that can help you modify your plan and go back in an accelerated model, rethink your minimum viable product and go back into the cycle.
So this, I’m not going to spend hardly any time on, other than these are the people to call at the NSF and the different funding areas. And this is a partial list, but if you go to this website, particular this link, it will give you the contact, scientific research contact, your program official, for every institute. So I have worked with all of these in the past couple of years and I have found them all to be extremely helpful.
The financial people are largely there for you after you get your grant. They can answer some questions about … Oops sorry, let me go back. They will answer some questions related to budgetary things but for the most part, they are there for you after the fact.
Okay. Tip four. Before you get started, you have to register your business. One of my clients registered his business with the NIH the day we were trying to submit the grant. It was the most insane day I’ve ever had. I never want to do it again. So you have to have all of these things done. I would prefer, as a consultant, the sooner the better.
The only one that we don’t help you with is your employer identification number which is through the Social Security Administration. But from one through six, these are all the steps you need to register your business with the NIH or the NSF. The DUNS number is the most important, tends to be done … It depends. They tell us two to eight weeks. Sometimes, it can be done shorter than that. But, if you’re going to put all this work into preparing a grant, I would, again, highly recommend you get all of these registrations out of the way well before the grant application is due.
So, again, this is the website you go to. This is a little sheet that I created for my own clients and collaborators, just so they know where to go. So once you go through all of these, you go through this system for awards management, you have to register your company, register it on the electronic application site which is ASSIST for the NIH. The NSF uses either ASSIST or it will use grants.gov, whichever you prefer. I think the ASSIST site is a little bit more user-friendly in terms of actually uploading documents and submitting your forms. You have to register it with the small business administration.
And then, at the NIH, you add your users to a company eRA profile, so this is made by your Chief Financial or administrative person. They need to create a user account at the NIH for your company and then anybody who can play with that grant has to be given access through the institutional official which, in your case, for a small business, would be either you as the CEO or one of your finance people. At a university, it’s usually the provost or a vice dean or dean of research.
Same thing with the NSF. Anybody who is helping you with your grant can’t just have access to it. You have to provide their login name and their email address. So if you get these out of the way early, it tends to make your life a lot easier and then as the grant application is approaching, you’re going to be focusing more of your time on that creative energy you need to actually get the science part right.
So, getting started, how to choose the correct level. Here, again, is our phase I, phase II, we’ve already talked about these. And in addition to giving you some of the timeframes and the funding amounts, it gives you the page limitations which is in a phase I, you have an aim page and six pages to sell your idea, in a phase II, you have a specific aims plus 12 pages. So you have a little more real estate, usually because you’re adding more data into the phase II.
The phase IIB which is, again, that early stage technology and getting market ready, this is where a lot of businesses fail. And then hopefully, going all the way into your phase III, we see a lot of companies that have 10 or 15 phase Is and then never are successful in getting into a phase II. Study sections tend to look at that and if they have had man phase Is without a lot of phase IIs, then it could raise a potential red flag as can this company actually bring a product beyond that proof of concept part of the application process.
So usually, in phase I, it’s that in vitro, in silico, maybe some small animal models. Just to get your target either prototype, device or drug. In phase II, they would like to see some sort of preclinical model, so out of rodents and into either a large animal model or into patients. At the end of phase II, beginning of phase IIB, you can do pilot clinical trials, safety, efficacy although most of those are done during this phase IIB or phase III.
What I like to tell people is at the end of phase II, you should be ready to have all your regulatory stuff be passed through the FDA so you can move forward. And we’ll talk about that a little bit in the next slide. And then, again, we have that fast track that’s the combination of a phase I, phase II.
So, for phase I, what we often see and through my experiences on study section is if you are an academic researcher that’s having trouble getting your discovery research, R01 type grant funded, an NSF research grant funded, just don’t take the same grant, call it an SBIR and put in the same thing. It’s not going to get scored well because the aims of these grants are fundamentally different.
I’ve seen people say, “Okay, I have my own small business and we have all the capabilities but it’s my home address because my small business is my house.” In phase I, you can be completely virtual. Just don’t hide it. There is nothing wrong with being a virtual company in the early phases. You just have to tell them who you are and don’t try to pretend to be something you’re not.
I’ve also seen researchers in the academic setting make a dummy company and then take their grad student and make the CEO. Remember, in your bio sketch, if you are going to be a senior official in a company, you have to have the bio sketch to go with it. So if you’re in your fourth year in graduate funding and haven’t had any business experience, you’re probably not going to be a good choice to be the CEO of the company.
Okay, now in the do things I like you to see is in the research plan significance, you have to look at the importance of the problem you’re addressing or what’s a barrier in the field that’s preventing progress. How is your project going to lead to a marketable product, process or service? In the academic biomedical research grants, we just want to look at really good ideas that are tackling a significant problem.
And we don’t care whether they can make it a market or not. In these grants, the commercial potential is as important as the science and that’s how the grants are actually reviewed, not just on the quality and the rigor of the science but whether or not you can move forward and actually get to market.
The phase Is is usually some sort of minimal viable product, either a lead compound or a prototype of a device. What you should do with all of these grants is look at what your milestone and proof of concept studies are. And really, think about your project deliverables. So what would be your Go / No Go situation, what criteria will you use to say, “I have my lead candidate, or I have my prototype device?”
And what I do see a lot in phase I that the study sections like to see some, if it’s a drug, some animal work, either in mice or rats. And if it’s as simple as a dose escalation study, you don’t need to do all of the ADME stuff with the absorption, distribution, metabolism and elimination, that’s for phase II. And again, what you want to have is a prototype at the end of phase I for your device and say, “Okay, once we reach this goal, we can then start the next phase which is to validate our lead prototype.” I’ve heard people say, “Lock in the design.”
We say you do not need proof of concept preliminary data. That’s true. And I’ve seen many grants get funded without it. But, if you have some and it’s really proof of concept, I highly encourage you to put it in but don’t put in data that isn’t directly related to your proof of concept or your hypothesis or your goal because that’s just wasting the real estate of the six pages to get your product across.
The fast track, it’s again a little bit funky because what you do is you simultaneously apply for phase I and phase II. The advantage to that is that you reduce or eliminate your funding gap. You tend to have … The phase I almost has to have preliminary data in this case. And what it usually means is that you got one or two little things left in phase I before you can go full force into phase II. That’s what is an intended for.
A lot of small businesses look at this and go, “Wow, I can get a lot more money for the same application because I can go right from phase I into phase II.” And although that is true, what we find is that overall, there is a lower success rate and there are less funds committed to this mechanism because very often, the small businesses do not have enough phase I proof of concept data to justify this fast track.
But in theory, you have that data, it’s rigorous, it’s seven to nine months to give you the first part of money. There is a checkpoint where you have to see if there was a satisfactory goals were met in your phase I final report. If you meet that successfully, you go on to phase II and you get the bigger pot of money. So this is how the mechanism should work.
But in addition to having a lower success rate, the NIH administrative staff, sometimes, it gives them a fit for their funding cycles because what if you hit this checkpoint and it’s not quite satisfactory so you have to delay your time going into phase II? That means they have money that was earmarked that they now have to do something else with. So this is an administrative burden. So my advice is, if you really have a fast track application, meaning that your phase I is almost done and you need just a little bit left, then this is a good mechanism.
But if you really should have the phase I and you’re just either looking for more money or trying to get not having to have this funding gap, I suggest you still go ahead with the phase I.
Okay, fast tracks. If you’re going to do this, just like a phase II or a direct to phase II, you should either have a provisional pattern or a patent. You have to have a very strong commercialization plan, milestones that lead at the end of the phase II to either submission of an IND, investigational new drug, an IDE, investigational device exemption that will allow you to go further into a clinical study to collect safety and effectiveness data.
There is also something called a 510(K) which is a premarket submission made to the FDA to say that my device is safe because there are already other devices similar to it on the market. I always tell our clients to plan a pre-meeting with the FDA as part of their budget because then it shows the study section that you’re looking ahead. I know at part of my phase II, if I want to go to the FDA, let me spend some of my budget, actually, getting set up for a meeting with the FDA which means you should have a consultant, you have a pre-meeting, you may need access to some patent stuff, regulatory affairs. So this is a good use of the budget money in your phase II.
Okay. When you’re planning your phase II, do not ignore your competition. In fact, you want to show how your product compares directly, head to head, what’s out there in the field. Do not wait till the last minute because you have to have this very well laid out. And I have seen people in phase II say their marketing strategy is that they would network at meetings and use social media. This is very much frowned upon because that is not a market strategy.
So, again, take this very seriously and spend the time and investment to make this very well done. I’m going to be gone in just a few seconds. Write that detailed commercialization plan. So the Nation Science Foundation for phase I, you still have to say these things like is there a societal need, what’s the market, what’s your market opportunity? And at the NIH, you don’t have to write a commercialization plan to either phase II, direct to phase II or for the fast track. Both of these are about 12 pages.
What you want to include is the value proposition. What your product development, what’s your regulatory pathway? And reference the standard of care of comparable products. Show the incidence of the disease you’re targeting. This is just an example. There are a couple of grants that NIAID puts out where we’re a successful SBIR application and I took this literally right out of this application.
And what is showing here is what is the incidence of the disease they are looking at in the population? So, the thing that I’m studying is actually a … Will have impact, it’s a market that I have to target and there is a need in my market.
Okay. Then market customer competition. This is where tables and graphs come in very handy. Who will buy your product? Who is your competition versus your strategic partner? And I love this table from that grant, the same NIAID site where, in this particular grant, the applicant listed the competitor, what their product was and how his product was going to be advantageous compared to the current market. This is great for reviewers because it’s laid out right in front of them so they can, when they’re asking, “Why does this guy or this woman think they can do it better?” You’re actually laying it out for them.
You have to make sure you have your IP stuff going, patenting, licensing rights. Finance plan. Letters of support from people that would either want to use your product or buy your product. And then this is one that people tend to forget which is now that I have all this, how am I going to go to market? How am I going to go from the R&D stage into the next phase which is to scale up, manufacture, market and sell. The more this is in detail and laid out, the more you’re going to get the reviewers on your side.
Okay. Last two tips. Tip nine is target your audience. The review panel has a very diverse membership. There is basic scientists, engineers, surgeons, physicians, people from pharma, former SBIR awardees. So there is going to be a range of expertise and perspective. So don’t write it for a very narrow audience. Tell your story. Yeah, again, six pages in phase I, 12 pages in phase II to sell your story.
To be successful, here are some of the elements. Define the unmet clinical need and commercial potential. Compare your product and how it is superior / unique to current state of the art. Include proof of concept data if you have it. Clearly define rigorous experimental strategy with end points and criteria on how you will evaluate your data to determine whether or not you meet your endpoint.
Make sure you add a reasonable timeline and an experimental approach where you say, “Okay, this is going to know if it worked. This is how we know if it won’t work and this is what we’ll do if it doesn’t do. How do I go back and take my minimum viable product and modify it to get it up to the standards I need to move forward?”
Remember, there are three reviewers that will read your entire application and now, with the internet, most actually do look up content on the internet. And they will be the ones that will be presenting your application to study section, the rest of the panel may read your abstract and Aims page. Not going to read the whole grant because they have their own that they had to read. And they will web surf in the middle of the discussion our panel if things were getting heated.
So very often, in the discussion, someone that is on the panel but not one of the primary reviewers will say, “Well, oh, I just went to this website, I found this.” So, people do go and look. So don’t ignore things, hoping that people, oh, they won’t find out because if I don’t say it in my grant, they won’t find it.
And then finally, here are some grant writing tips or, as I like to say, how to avoid upsetting the reviewers. Because a lot of people on the panel, besides your primary reviewers, look at the specific aim page, the most important part is the research plan. Phase I, you have to look at significance and innovation. That’s what they’re going to say is do you have a commercialization potential?
In phase II, your commercialization plan, a separate 12 page document, your significance and innovation must align. The more letters of support you get for your product on either how it will be marketed, who would use it or why it’s important, the more support letters you have, the better it is. You can have 20 of them if they are all to the point.
Remember, what the reviewers are doing. They are doing these grant reviews on top of their day job. So don’t make your figures tiny so they have to blow it up 300 times just to see it. Put spaces between your paragraphs so their eyes don’t break. Avoid the technical jargon and abbreviations, give them your milestones, tell them how you’re going to research your Go/No Go decisions and don’t be overambitious. Don’t put in 10 years of research in a six month phase I plan.
And try to match your budget to make your research plan the doable and feasible. If you ask for too little, they’re like, “Oh my God, they can’t do this.” If you ask for too much, they’re like, “Well, they’re just trying to get extra money.” So that is a very important part of this.
Sorry, I went a little over. But at this point, I would like to open up for questions.
Thank you so much, Dr. Lucchesi. Really great advice and some great tips. Somebody had a question about first and foremost about the DUNS number. Is that being phased out soon or?
I have not seen anything. It may be that they will stop doing that but to my knowledge, it is still required for at least the upcoming applications.
Great. And then can one company have more than one DUNS number?
I don’t believe so unless it’s sort of … Break out their company. So, I think it’s only one per. But also, one company can apply for more than one grant at the same time. So they could put a phase I in for one and a phase II for a similar project. Just can’t be identical, obviously.
Great. And then you spoke a little about letters of support and can you emphasize again the importance of letters of support, maybe some elements that should be in there?
Right. So usually, they are the hardest to obtain because you’re going to maybe people that don’t know you well that are busy. So I actually suggest to the PIs that you bullet point what you want to be in the letter. And in my experience, if it’s a device, say my field is cardiac and cardiovascular so I worked on one about aortic valve replacement. So for that company, they needed to get cardiologists that will say, “Yes, this is a great design and this would improve our ability to replace valves.”
They would want maybe a letter from a Corporation saying, “Yes, we’re really interested in your product. And we are looking forward as you advance to market and becoming a future partner.” That’s more for phase II. But for phase I, anything that you can get from an expert in the field that will justify why your product is going to be better than someone else’s or that the disease you’re targeting is particularly relevant and/or more anybody that’s got that marketing or sort of next higher level business that says, “Yes, we are investing in this type of technology or in these drug therapeutics.”
That, what it does, is it tells the review panel that, “Okay, they’re not just telling us why they are important. They actually have experts outside, external to their company, that are providing these types of letters.”
So, if you are a businessman that’s never done research in heart failure and you’re going into all about why how you know this is the best treatment for heart failure, it would be nice to have a cardiologist that deals in heart failure to give you a letter. But it takes a while because they are doing this for nothing. You are not paying them to write you a letter, that would become illegal. So you’re asking for something from them, from a busy person. So you have to ask early, ask often and give them a bullet list or even a draft of what the letter should say. That’s how you get people to give you the letter back.