Transcript: DoD Funding Strategies: Understand the DoD Perspective

Presented by Dr. Kiselycznyk on 5 May 2020  Watch the Webinar 

Today’s webinar is presented by Dr. Kiselycznyk. As a former DoD grants officer at USAMRD, Dr. Kiselycznyk wrote and negotiated funding opportunities for medical research and development. She acted as a point of contact for research scientists trying to navigate the priorities and regulations of DoD leadership and contracting officers.

She is also the founder of a medical device startup and has been on the applicant side of successful NIH and NSF SBIR awards. Dr. Kiselycznyk was trained in neuroscience through a graduate partnership program at the NIH and the Karolinska Institute in Stockholm, Sweden. Her research focused on the molecular and behavioral neuroscience of stress and resilience with a postdoctoral fellowship at Yale University researching ketamine for treatment-resistant depression.

She holds a PhD in medical sciences from the Karolinska Institute and a bachelor’s in biological sciences from Cornell University. Thank you so much for being here today, Dr. Kiselycznyk. I’m going to turn the presentation over to you now.

Thank you so much for the introduction and thank you for hosting this. I want to give a little bit more about my background, just an overview. So, I was trained initially as an academic research scientist at the National Institutes of Health and then went on to work with the Department of Defense as a grants officer or science officer who was the go between those research scientists and DoD funders.

And there, we helped both scientists negotiates the process for DoD and then also I worked in the office to decide where DoD defunding should go and develop those funding solicitations that you would then apply to as an applicant. Since then, I turned around and applied for my own government grants for the SBIR program, through the National Science Foundation and National Institutes of Health as I started my own medical device startup.

So, I have been on both sides of the table, both as a research scientist, founder of a startup applying for these awards and also on the DoD side and dealing with how to get money out the door from a government agency. So, I want to share with you guys what I’ve learned from both sides of it and give you what I found very helpful when I was applying for my own grants is understanding that perspective of the DoD and their motivations and pressures they’re dealing with in getting their own job done.

So, more context about where I worked at DoD. And I just want to stress, I am no longer at the DoD right now, so I’m no way acting as a representative of the DoD for this webinar. But I’m going to share with you what I learned when I did work there. The DoD is a very big place, and I’m not going to go over the organization during this talk, but for context, I was working in what is traditionally a branch from the U.S Army. And they have multiple different centers focusing on different types of technology across the U.S.

I was at a program office specifically focused on medical research and development. And it’s at the U.S Army Medical Research and Development Command or USAMRDC, or as formerly known as MRMC in case you were familiar with it from before. This is located up in Frederick, Maryland, which is about an hour or two from DC and from other centers like the NIH and NSF. And is the base at Fort Detrick, Maryland.

And this organization again is changing. There is a new effort to make sure all the medical and health research across the DoD is more coordinated across the Army, Navy, and Marines and air force. And this is happening under the defense health agency. So, we also worked under the defense health agency at the same time. So, while working at this office, we used to joke that our tagline or emails should be, it shouldn’t be this hard to give away money. It sounds like a great job, you work as a scientist to now help give away money for great science projects, but the staff there has their own pressures and time constraints to deal with this. And it can be surprisingly difficult to get money out the door.

So today, I just want to give you guys context about what they’re going through when they’re trying to fund research so you can help them do their job and get money out the door and into the hands of investigators. A brief overview of what I’m going to go over today. I want to go over just, one, the general goals of DoD. And when they’re focused on military products and solutions, and when instead they might be focused on more general public purpose or civilian applications. I’m then going to dive into the fun term of DoD acquisitions, just to give you a general idea of what that’s about.

And then we’re going to talk about some of the constraints the DoD staffs works under, one, just the general federal funding rules and regulations that all government employees have to deal with. And then two, some DoD-specific concerns that might come as a surprise to you. I’ll share with you some resources of where to get more information and then we’ll have time for Q and A.

Next week I’m also giving a webinar and there I’ll dive more in depth to the different types of funding opportunities the DoD might put out and the different ways and agreements they can give you money so you’ll better understand the pros and cons of each opportunity and can be more strategic about which ones you apply to.

Okay. First of all, I want to give you some context about the broad DoD goals when funding research. Most of us usually think of the DoD as being focused on investing in products or technologies that they themselves want to use for the military. They are often the customer or users of technology they’re investing in as opposed to the NIH or NSF, who is just generally funding research for the public good and do not expect to get something in return.

So generally, the DoD is going to be a bit pickier about what they ask for and might ask you for a bit more or a bit more specific deliverables because they actually want to use the thing you’re developing. At the base I was working on focused on medical products, we had a few military-focused research programs. I was working in one called the Medical Simulation Information Sciences Research Program, where we focused on how to train service members to give medical care in the field per se. There are other ones focused on Combat Casualty Care or Military Infectious Diseases.

They’re specifically focused on applications for the military. However, this is not always the case. There are other programs that can be focused on funding research for just the general public good and might be mandated that it has to include something for the general public as well. The example where I was working, at USAMRDC, there is another in parallel branch called the Congressionally Directed Medical Research Program or CDMRP that works closely with these military programs.

And these fund research and general topics like breast cancer, or autism, or vision science. And these program areas can change year to year. So, these are topics that are just for the general public good and health and were more similar to like an NIH RO1 than a specific military contract. And it helps to understand some of the history for this to understand why these programs exist.

Previously, the government wanted to invest more in breast cancer, and they typically would do that through the NIH. And they simply could not within budgetary rules increase the budget enough within NIH to fund this research. They realized they could do it within DoD, so this became a program for Congress to funnel more research money for medical research, just within the budgetary rules. It just happens to be through DoD as opposed to the NIH. So, there are a lot of programs people don’t realize they’re there for the general public. And I encourage you to look at both of these and not assume everything is just for the military.

I do want to dive into though the process for when the DoD is seeking out something for a military-specific application, and we’re going to dive into the term called DoD acquisitions. We’re going to talk a lot about specific DoD terms that seem dense at first, but I’m going to try and break it down for you. So, this is basically just the term for how the DoD acquires technology or products to address some unmet need they have, unmet need or what they call requirements.

Now, the goal in this webinar, I do not want you to try and learn the details about DoD acquisitions, but I want you to come away with some basic principles code you can speak the lingo a bit better. This is an example of wall chart or a poster you might find in some DoD offices. And it details, all the fun acronyms, and documents, and processes needed to do the formal DoD acquisitions process. You do not need to know all this, but just be aware that some of the DoD program staff might be experts in this and geek out in this and some might not be. But this is the very detailed process they’re supposed to be following for investing in technology.

All this is based on working towards something called requirements. And this is just their term to define the system, to identify and prioritize these unmet needs or problems in the military they need to address. So, they’re trying to list these unmet needs or requirements across the military. There’s a specific office to deal with this called the JCIDS office, and again, you don’t need to know all these acronyms.

There’s one office defining what these unmet needs are that need to be solved. There’s another office dealing with the funding and how we’re going to fund these projects. And another one managing the process to develop these technologies. This is all just formal language for something we all do in technology development, or if you’re a startup founder is, one, just how do you define your customer or user’s problem and know they’re going to invest resources in it? The DoD is basically doing that for you. They have a very formal process to define a specific problem, what it would take to meet that problem, and what resources should be invested in that.

The better you can understand this process, the better you’re going to be able to understand your customer or the DoD’s problems and how you can help them address it. The way they try and address these requirements or unmet needs is through the DoD acquisitions life cycle. And this, again, is just their term for that kind of plan or process they use to fulfill that requirement or unmet need. This chart here is the acquisitions life cycle is basically a simplified version of that big wall chart I showed you earlier.

And if we look at it, this is just the different stages of technology development along the way to something that’s finally deployed. Once they have a defined requirement or unmet need, they go back and do market research, see if that technology some solution is available off the shelf. If it doesn’t exist in the world yet, they will go back and decide to invest in developing that technology themselves. If you go back in the early yellow in the start of this life cycle, they will just start with basic research or proof of concept testing.

Once they prove they’ve done that successfully, in some milestone, you see in the triangles above, they get to move to the next stage, which is, say, from proof of concept to prototyping. If they show they’ve done that well enough, they get to move to the next milestone. And finally, it’s something like engineering and manufacturing that solution. They do that well, then they can produce and deploy it, and finally they move to the purple stage of operations and support where they’re fielding it and maintaining it over time.

Most of you who are doing early research are going to be somewhere in the beginning, in that red area for doing early research. And that’s what typically they’re funding for early studies. This is a very linear, traditional process and it is best suited for a 10 year project with billions of dollars on it, or we used to joke something like an aircraft carrier.

It is not well suited for more iterative processes like software development and that’s something they struggle with as well. So, this is what they’re supposed to be doing, but this traditional framework, don’t be surprised, but it doesn’t always fit well with your technology. So, they do the best they can to adapt this to whatever technology they’re trying to invest in. There is an attempt right now to make this more adaptive for new technologies.

Again, you don’t need to memorize this, but this is their new attempt to develop a more iterative framework appropriate for, say, software development. So, they’re trying to make acquisitions process and you can see in the middle for software development that is more iterative. Where I worked, we would try to adapt this for medical products. So again, this is just taking these formal duty terms and making it analogous to the technology we are working in.

So here, if you’re developing a new drug, we have the early yellow stage it’s just a preclinical stage of drug development. If they successfully do that well and pass something called milestone A and prove they’ve done it right, then they can move on and get more resources to do a phase one clinical trial. So, this is all terminology we’ve probably seen before. It’s just in a DoD lingo.

They’ve broken up this the same for medical devices and just broken out each stage. Now, why is this important? Is because the DoD is going to assign your technology a number to define where it is along this pathway. And we call these technology readiness levels or TRLs. So, you can see the red number on the bottom. It’s just aligning to some phase of this DoD life cycle. And what they really want to show is they want to be able to label your technology of where it is at the start of your project, and then show, by investing their DoD money, it’s moved along to a higher number.

So, at the start of your project, you’re at TRL3 and at the end, they can show they’ve invested money and moved this product to TRL5 and therefore gotten closer to fulfilling that requirement. So, they will try and label it somewhere along this continuum. There is also something called knowledge readiness levels or KRLs. This is for something that’s not traditional technology. It’s something more like a clinical guidance document or SOP. This was still in draft phase last time I saw it, but just be aware of this acronym as well for the KRLs TRLs.

Now, at the same time, where you are on this life cycle defines what type of money they can award you from the DoD. So, along each of these TRLs is a different pot of money from 6.1 label to something called 6.7, and we call these colors of money or program elements. So, they have discrete buckets of money in each of these types of funding. And so, they can fund a certain amount of, say, prototyping or engineering.

So, they need to know how many projects they’re going to be funding within each of those TRLs. And that’s why they really want to label where you are for your technology. Only when they pass certain milestones, like milestone B, are they able then to convince leadership they should get more money for the next stage of money, say, six, four dollars. So, this is really important than to label where you are in this process.

What does this mean overall? So generally, I just want you to understand that this is how the DoD staff is thinking and they want to demonstrate to their own leadership and their own boss how that pot of money they’ve used in the funding has helped advance the TRL closer to fulfilling that requirement. So, we’re trying to help them show that this money has been used to move that technology forward.

They will have their own nice summary that they’re sharing with their leadership typically called something like a quad chart. And you can see an example of that here that is showing each of their technology investments in a simple one pager. So, there’ll be one quadrant showing the objectives of the study, the requirements they’re working towards. Another quadrant showing off the product and some nice photos. And then maybe another one showing that the number of dollars they’ve invested, what the TRL was at the start and then where the TRL was after the project finished.

The takeaway for you as potential applicants is, one, to really talk to that DoD staff to understand the requirements they’re working towards so you can better understand your customer’s problem and also help them show how they’re moving the TRL forward. So, if you can understand the definitions of those TRLs, you make it easier to show off to their own leaders or bosses how they’ve helped move that forward. And the more likely they might be to fund you in the future.

Okay. So, that is what the DoD staff is trying to work towards and moving towards those requirements. At the same time, they spend a lot of energy focused on not breaking any rules in the process. There are a lot of strict regulations and rules in how to spend government money. So, they can be very conservative of trying to make sure that they are staying within those while still trying to get their job done.

So, first I want to cover some of the general federal funding roles, that’s going to be the same across DoD, NIH, NSF just so you’d understand them. And then we’ll go into some DoD-specific issues. So first, I want to go over some of the three main acts that the government employees are going to be worried about. And I’m going to talk about them in my own words, but they also have the formal definitions after this for your reference.

And this is basically making sure you’re only spending money on something that’s approved for a specific purpose in a certain timeline. The first is the Anti-deficiency Act so the DoD cannot incur costs or services beyond what’s been approved. What this means is that the DoD is going to be very careful in talking to you about any additional work. They don’t want to encourage you to start work on award before you’ve officially gotten the award letter or officially approved funding.

And also, once you have an award, they’re going to be very hesitant to ever encourage you to do work above and beyond what was formally approved. So, if you’re willing to do extra work for free, don’t be surprised if they’re hesitant to respond to that enthusiastically, because they don’t want to be seen as encouraging you to incur more time costs to an award.

The second one is the Misappropriation Act. DoD staff cannot use funds beyond their approved purpose. And this leads to them not being able to use different types of money for a different level of technology. So, they can’t use $6.20 for prototyping and put it on to manufacturing.

The last one I’ll talk more about is a Bona Fide Need Rule. And basically they need to use the funds for what it was intended or they need to have an actual need for those funds when they asked for them. And what this means is that they can’t ask for money now and then decide just to hold onto it in case they need it in the future. What this means is that there is a big time pressure to spend this money in time, because otherwise it will be sent back to the treasury instead of staying within DoD.

There are the formal definitions of each act here, so I’m not going to go into detail about. But I want to just spend another second on what this means for that timeline to spend funds, because this is a major pressure at the DoD. And just a bit on terminology, when we talk about committed funds versus obligated funds, committed funds is more when they pencil in a project on the budget and set aside money. This is, as an investigator, after you’ve gotten through peer or programmatic review and you might get a letter saying you’ve been recommended for funding. It’s not official, but they’ve penciled in funds for you.

The obligated funds is when you receive that formal letter that you are officially getting the award. It is that award letter is that legal agreement from the government and the awardee. And this is after you’ve done all those kinds of either negotiations and back and forth, or like just in time process from if you work with the NIH. What they care about is getting funds obligated in time.

The timelines they have to obligate funds might differ between the type of money and the type of solicitation they have out there. But I’ll just give you an example from the type of grants they did at that place, the CDMRP. They usually had two years to obligate their research funds. This can sound like a lot of time, but that’s two years to decide on the program areas for that year, decide on, get all the experts together and make a funding opportunity or program announcement and decide what they wanted to prioritize. They then have to post that publicly for enough time and then give researchers enough time to write up proposals and respond to that.

Then they would have peer review, second level of review for programmatic review, after all that was done and they’ve narrowed down which awards they might want to fund, it would come to us for scientific negotiations, trying to get that done within six weeks, if we could. And then after that, they would need another three to six months to send over to the contracting office to actually make that official award agreement.

This ended up often being very close in timing, so there’s often a scramble to get this done in time. Sometimes if an award falls through, then they’ll end up with leftover money sitting there they need to figure out what to do with. So, overview of this time pressure to spend funds. There might be different rules for different funding opportunities or type of money.

The DoD staff really cares about that number, that percentage of funds they’ve been able to spend and they have something called obligation rates they want to show off to their own leadership each fiscal year. So, they really care about showing off what products they’ve made happen, and invested in and the TRLs they moved forward. And they care about those obligation rates. This can get really challenging as there’s delays in the budget and were often under continuing resolution. And often with shutdowns, it can totally change the schedule for things.

The takeaway for you as an applicant, and I’ll talk about this more next week, is considering different funding opportunities that can help out the DoD if they’re left with extra money towards the end of the fiscal year. There’s some funding opportunities that are a bit more of a grab bag that can move faster and it doesn’t hurt to apply to those to help them out in case they have more funds sitting there they don’t know what to do with.

Another thing we always look at when we’re negotiating and looking at awards is making sure there’s no duplication in funding or scientific overlap. Basically we don’t want investigators double dipping and giving funding from the government twice for the same specific research aim. When we think you might be awarded, we will ask you for a form of all the other grants you’re receiving. And then we’ll also look at federal databases to see what else you’ve received to make sure you didn’t, say, both apply to the NIH and DoD for the same research aims and are getting the same money twice.

Take away for you on this is, when drafting out your first proposals, to make sure they’re fairly specific and discrete because you don’t want to start with your first grant on something very broad and then the next time you want to apply for another grant, you find it looks like it overlaps with the first one. So, try and keep it focused on a really discreet topic area.

We also look at your level of effort as an investigator. We’re often concerned that researchers might be overextended across all the different grants they’re doing. So we, again, will look at that list of all your pending and current support from other awards and make sure you’re not above a hundred percent time. One, they want to make sure you actually have time to pull off the project you say you’re going to do. And also they’re very wary of investigators paying themselves too much off of federal money. So, they don’t want to see you paying yourself more than a hundred percent of your salary so they are often very strict about that.

Okay. This section I want to go from just the broad, general federal concerns to some specific issues within the DoD that might surprise people that haven’t applied here before. One is that if you’re looking to do any human subjects work or animal research, you are going to have additional regulations from DoD funding. This is mandated in some acts that DoD funding requires this and often due to public perception about making sure the DoD is not funding unethical human subjects research or animal work.

There is an office called the Office of Research Protection and under that is a Human Research Protection Office called HRPO. And there’s an Animal Care and Use Review Office called ACURO. This is going to be on top of your traditional Institutional Review Board or IRB or your IACUC approvals. So basically you need to go and get your IRB or IACUC approvals, and then submit your protocol and informed consent documents to the HRPO office as well to get their approval on top of that and keep them updated throughout your research.

This will add delays to your research schedule. Typically, they say that the HRPO review adds two to three months of time. It can take longer than that, don’t be surprised. So, that first year can be tough to get much human subjects research done. This is one reason that it’s typically not feasible to do human subjects or animal work within shorter awards.

So, if you’re looking to do a six month phase I small business grant or SBIR, it’s typically not feasible to do human subjects work within this timeframe because it takes too long to wait for HRPO. So, whereas places like NIH you might be able to do human subjects, I wouldn’t recommend pursuing SBIRs for human subjects work for the DoD. For certain types of human subjects works, they also might change how you were funded on the award.

So, they might just fund you for the first year, say, if you have a five-year award, and make the remaining funding conditional on you getting your HRPO or ACURO approval. So they’ll structure the rest of it as an option for funding. They just want to make sure they’re not funding you for five years if it ends up being you’re not allowed to do that human subjects work. Okay. So, this is regulations for any human subjects or animal work, civilian or military, funded by the DoD.

Now, if you’re looking to do research or human subjects work specifically in a military population, there’s a couple things you should be aware of. One, it is typically considered a vulnerable population. And this is because there are tricky consent rules in making sure consent is truly voluntary within the command structure of the military. So, you should review the issues regarding that.

Typically, you’re going to need that service members command to get permission for them to be involved in this study, but at the same time that command cannot help you with recruitment so it’s not appearing like they’re commanding their service members to join your study. You also cannot pay service members or other federal employees compensation for joining your study unless they’re on leave or off duty.

So, it’s helpful to review these special kind of rules for this population. All this leads to consistent issues and difficulty with recruitment if you’re trying to do a research study with military. We had a lot of studies trying to do research in military populations. And more often than not, they would fail to reach their recruitment goals. So most of the DoD offices are going to be very cognizant of this problem because they’ve dealt with it so many times.

You’re going to want to show them how you can do risk this in showing them you’re prepared or have some experience with the military population. Having a letter of support with whatever commands you want to work with is crucial and you also are going to want to have probably some recruitment personnel or staff who’s worked with the military before.

The population you work with is not like working with a college population, they’re going to have very little time or flexible schedules for your studies. We had a lot of recruitment fatigue, so it turned out there were a couple of bases that maybe were welcoming. Research studies are a good population for that, but so much research and so many researchers were flocking to those military bases. They ended up with a lot of just fatigue among the population who had just been in one too many studies and just were no longer interested in volunteering.

So, this is a consistent issue. One example I had was in my portfolio trying to fund research on if therapeutic dogs were useful for post-traumatic stress and we could not successfully recruit service members to take part in a study where they hung out with a dog a couple of times a week. So, things you think people would be interested in often still don’t work out.

I also want to stress making sure you understand the intended use case that the DoD is interested in. And most of the time, this means focusing on something that is very rugged and lightweight. We were focusing a lot on injury prevention and health when service members were out in the field. And there was a lot of frustration with the DoD funders of seeing another proposal for some fancy wearable that had really sensitive sensors that would break easily or short battery life and was just always too heavy.

They already are crammed with too much weight and you pretty much need no weight or somehow reducing weight for most products to be successful. An example for the medical products is understanding the context is we had very specific language and definitions for different roles of care for medical products. So, role one through four, role one was a immediate lifesaving care, something in the field, the disease and injury prevention, anything that was in your backpack or in your ruck as we say.

Role two is more the trauma management and forward surgical care, maybe a transport or some access to better a truck or a helicopter. So we used to say ruck to truck. And then role three is more of that deployed hospital or all types of patients in surgery and post-op care. And rule four is more established hospital in the U.S or overseas.

So, it really helps to know what context they’re looking for this technology to be applied to. So, you know not to waste your time with something very heavy or sensitive for a role one application as opposed to an established hospital.

Okay. Finally, I want to just give some tips in learning how to communicate with the DoD staff. One, you want to try and understand their rules for communication. There are very often strict regulations about when DoD funders are allowed to communicate with potential investigators. And this depends on what type of funding opportunity they’re writing.

So, it’s different if they’re writing for a military contracts called an RFP, and then there’s a very strict timeline or window of time they are allowed to talk to potential applicants. Because any advice they give to one person they have to have time to share with everyone before they apply it. This might be different than, say, the NIH and NSF, because in the DoD, we have a mixture of these different types of solicitation and a mixture of rules.

Oftentimes in our office, we would start writing funding opportunities for our type of technology. And we wouldn’t know till later what type of funding opportunity it would turn out to be and so what rules would be applied. So, often you see officers being very conservative or hesitant to talk to people because they’re just not sure about the rules. It helps to do your own homework and if you are trying to reach out and communicate with them, check on that published window of time that you’re allowed to be talking to them and even put that in your email being, “Hey right now is the open period. Can you answer this question?” As it says in the solicitation you’re allowed to answer.

There are also other ways to reach out and communicate. There is an office of small business programs, if you’re a small business and want to know how to do business with the DoD. Because of the strict rules of talking to the staff for actual active solicitations, they’ve initiated a new product idea submission. So, it’s a way for you to tell them the technologies you think would be useful to them. And this is, again, specifically for that one base in medical products.

There’s also industry partnership days where you can go in person and have a table. And I definitely encourage you to do this, to get face-to-face time. They can be much more open to talking in person over written email. Check out what specific conferences for your fields, we always went to the MHSRS, which is Military Health System Research Symposium. And there’s also some new technology consortium’s which can help get you to know them better.

We had one for medical technology enterprise consortium. It’s basically, you get to sign up to be in a small cohort of different technologies and have opportunities for solicitations which the general public would not have. I definitely encourage you to try and reach out to them early when you have a technology it’s hard. The DoD staff tries to be aware and do their own market research on what technology is out there and be up-to-date on the state of science, but there’s only so much time in the day.

So, when they’re writing solicitations, they try and write them for what is feasible and possible. And it doesn’t hurt to let them know you have a technology out there that they could write a funding opportunity. It allows them to write a new funding opportunity. We often would get notifications from the small business or SBIR office that there’s an opportunity for us to write a solicitation or a topic idea because they have money for us. And sometimes we would let that pass by just because we didn’t have an idea at that time for a topic area for a grant. So, if we have people reach out to us, it gives us inspiration to raise solicitations.

Finally, I just want to encourage you to learn some of the military language. You don’t have to be an expert, but enough not to make faux pas. So, if you’re talking, know the different branches of the military, don’t call Marine soldiers, et cetera. And if you’re writing to different military staff, learn the different rankings and abbreviations between military branches. So know how to abbreviate Colonel for the army versus the Navy, et cetera.

Going to share a few resources you guys can look to after this. There are some official documents that you definitely don’t expect to read them, but they’re good reference documents for the formal rules. One is the FAR or the rules for Federal Acquisitions Regulations for, say, government funding for contracts. There is a separate guidance document for DoD funding for grants as opposed to contracts. And I’ll talk about this more next week, and this document is the DoDGAR.

For the acquisitions process, there’s the DoDI 5,000 and for the requirements process, there is the JCIDS manual. Again, do not expect to read these in depth. If you want just an overview and start learning the process, there’s a few educational resources. One is a website called the Defense Acquisition University. Most of this material is just open to DoD staff, but there are some publicly available documents such as a simple guidebook. And there’s also information on our website for this new attempt at making more adaptive acquisitions process.

For the medical products, there is a similar guidance document for the acquisition process for medical products, which is a handy PDF. And also I recommend checking out the CDMRP website because they have a nice layout and overview for those academic investigators who are new to DoD that tells them about the process and what to expect if they’re funded. You can also get some of the forms you’d be expected to fill out on the eBRAP.org website.

Finally, I just want to reiterate some of the ways you can connect with the DoD, the office of small businesses. There’s a guide to doing business with the DoD, and I encourage you to look at those submission new product ideas and other in person events you can apply to.

So again, this is just trying to get you familiar with their thought process and pressures, their motivations and pressures that they’re dealing with so you can help them do their job of getting money out the door. And just not to be scared off by some of that lingo, it’s just their own formal way of putting new fancy terms like acquisitions on some concepts most of us already know.

Next week, I’ll go more into depth of specific types of funding opportunities and the official terms and different ways they can give investigators money so you can understand the pros and cons of each and then understand the strategy of how to apply for DoD funding. And that is it. And I welcome any questions.

Thank you, Dr. Kiselycznyk, so much for all this great information. We do have a few questions. The first one is, I think it’s also in the chat box for everybody to see is, under new product ideas, how widespread is this available throughout DoD?

I am not a hundred percent sure on that. I know better from USAMRDC. I believe there are mechanisms in different areas as well, but I’d have to double check on specifically because DoD is a very large place, but most research areas there probably is a mechanism to do that.

Now, in regards to with the MHSRS council this year, do you think emailing or going through new product ideas or another resource is the best way to gain exposure?

Yeah. I don’t know what, if you’re thinking about what is maybe not happening in person this year and how to adapt to that, in general, I would recommend the in-person events like the MHSRS or the military industrial partnership days. Because I’m sure some groups are more aware of the new product submission than others.

Do not be surprised if you didn’t get a response with the new product ideas. So, I would definitely follow up with that more if you can find an excuse to reach out to them in that kind of window of time where you’re allowed to. So I always, when I applied for my own grants, just found an excuse to ask some specific question within those windows of time, just to start that relationship going.

Great. Now, where do you SBIR grants fit into this whole process?

Yeah. We’ll talk about this more next week as well. That is something that each research area might submit topic ideas to the technology they want to fund. Funding is set aside from their total research budget and it’s more under the rules of the small business administration. So, the DoD is not able to control those as much as their other funding. So, often a lot of the goals there would be more for the small business administration as opposed to the DoD staff.

So, we would write topic areas, but we weren’t as in control of the rules. Some research areas love to use them, some didn’t like that they lost that control. They’re also different in how they’re managed, so I wouldn’t be surprised if some research areas don’t leverage them as much as others.

Now, are you familiar with Steve Blank’s Lean LaunchPad method?

Yes.

Now, how has that simplified DoD grantors process in your opinion?

The grantors process? I mean, I think they are trying to find ways to work with the acquisition frameworks and the rules to fit within a more lean iterative process. And we can see that with that attempt to make that new adaptive acquisitions framework where you can see the little turning arrows of a software process. That is all very new and basically the rules are not set up for that kind of lean iterative process. There was also just an article out saying we need to catch up the requirements process to be more iterative as well because they are defining a problem and it takes them about five years just to get to the point of defining that problem.

So, they’re talking about it. Next week we’ll talk about ways they’re trying to be creative to get money out the door within the rules, but not stuck with that framework. So, they are trying and they are aware it’s a problem, but it’s not built for that iterative lean process.

Great. Now we had another question. I know we were talking about the DoD opportunities, but we do have a question that popped up in regards to folks working on NSF SBIR application. We know that you’re affiliate with ScienceDocs. Now, how can ScienceDocs assist folks going through the NSF and SBIR application process?

Yeah. I mean, I always advise people to, one, make sure to start by looking at the opportunities between different agencies. So, make sure yours is a good fit for NSF versus DoD. I’ve applied to a bunch of different ones, and it’s often you see people going for NSF because a good place to start, but their technology is not always as innovative as NSF ones. Whereas DoD, they might just want the product and not be as worried about being super innovative.

ScienceDocs can help just looking over outlining if your technology is a good fit for that opportunity and then sitting down and helping you draft that proposal and give feedback to see, is this hitting the mark for NSF, are you communicating it well to really get across what they’re looking for and giving you their perspective of what the NSF is thinking about and what’s been successful in the past. So, we can really help make sure you’re focused on something as innovative enough, which they really care about and that is appropriate for a specific research objectives and aims that they’re looking for.

Now, for general topics like breast cancer, is there no expectation to give the project a military focus or a link to a project to a military need?

Not for CDMRP, but you have to look at for that solicitation, is it for public purpose or a specific military. For CDMRP, the breast cancer, autism, it doesn’t need to be applicable to the military. It doesn’t hurt to mention how that might benefit military populations and families as well, because you’re going to have some of the same… Consider the people who are on that kind of programmatic review board, there’s a lot of military overlap, but it doesn’t have to be, in fact, it has to be more of public purpose.

Can you share some more insight in regards to what’s involved in that additional DoD regulatory review you earlier spoke about?

Yeah. So, it’s basically a second level IRB. Once you have your IRB approval, you’re going to need to send the HRPO office your informed consent docs, your protocols, your advertisement materials, just like you would your IRB. And you need to keep them up-to-date of any changes to your protocol and also do a continuing review with them. They’re going to check it and make sure to add DoD-specific language to some of your protocols that they have to add. And specifically look for those consent issues for the military population. So, it’s basically on top of your IRB, but a similar process to that.

Great. We just had another question come in. Planning applications to benefit military population. Is it acceptable to complete the studies in a civilian population to complete development?

So, it depends what the end goals are. I mean, the one thing I will say is, if that’s appropriate for the technology to start it in a population that’s easier to recruit, that might be feasible, just read the solicitation and talk to the staff to see if they’re really looking for something that can only be done in the military population. One thing you definitely don’t want to do is apply and get awarded saying you intend to do it in the military population and then halfway through your study, you realize recruitment is too hard. And then ask for permission to switch to a civilian population.

We would see that a couple of times, and it was just everyone had recruitment issues. This is not why we funded you. So, if you’re doing for a military-specific research area, obviously if you could do it in a military-focused population, that’s going to be more competitive. Just know what they’re looking for and make sure it’s applicable to that.

Great. Now, does the DoD review process involved a scoring system?

Yeah. So, they will both have the peer review process where you get that numerical score from the peer review, but then they also have, at least for CDMRP, they also have a second level of review for a programmatic review, which is less numerical, but it’s mainly where does it fit in their portfolio?

So, from the peer review, they’ll want to have a cutoff of a certain award number level. And then they’ll go through programmatic review just to see more subjectively where it fits in the portfolio. That is for CDMRP assistance agreements. There’s going to be a different process if you’re applying to, and we’ll go into this next week, an RFP request for proposals. There’s the government contract and then there’s the source selection board, which is a very different process than the typical scientific peer review. So there, it’s helpful to know what you’re applying to.

Now, just at tail end of that to tack onto it. Can you shed some light into what is an acceptable score and how long does the submission take from application to funding?

It’s pretty well laid out for the timeline on the CDMRP website for those specific funding opportunities how long that takes. I encourage you to look there. And then I believe, I’m trying to remember top of my head, I think lowest number as the best score. It was about threes, maybe four sometimes. We saw some awards funded that were higher or less good score than was recommended. But it’s a wide range depending on that portfolio.

It depends on the funding solicitation you are applying to. CDMRP is much more like an RO1, whereas can be more competitive and have a set score that they’re looking for a cutoff. Other awards are kind of a grab bag.

Now, does DoD have any restrictions on initial Cortech IP awarded to a university outside of the country?

It’s going to depend on the solicitation you’re applying to. If you’re saying IP awarded to some institute outside of the U.S, I think it just depends on the end goals. I don’t think that’s really an issue. If you have IP outside of there, it’s more of an issue of when government money is going to a non U.S institute is more of the strict rules. I can’t think of anything specific with foreign IP, as long as you have the rights to use it for the technology.

Great. Now, you mentioned applying for different funding opportunities to improve chances of funding. Were you talking about more specific topics versus broader topics?

I will go over this more next week, but there are different funding mechanisms, not so much specific versus general, but say CDMRP has very structured program announcements that are along cycle versus there’s something called the broad agency announcement, which doesn’t have a set budget or set topics and you can apply to whatever you think is interesting to them and it’s a much shorter timeline for review.

So, that is one that is good to consider if your idea doesn’t fit somewhere and it’s towards end of the fiscal year and they need to put money on something. So, there’s different structures, different budget amounts and different timelines for award for different types of funding agreements.

All right. Well, I know you already spoke about your next talk in regards to DoD funding strategies is understanding the options for DoD funding and you shed some light in regards to what you’re going to be speaking of. So, that is on Tuesday June 16, 2020 at 1:00 PM. And there’s this slide, so you can RSVP over at the ULP website. Is there anything else you’d like to add in regards to the next event, Carly?

No, I think I will dive into more how these rules fit in for each different type of solicitation, but I just want to encourage you, if you only know about SBIRs from the DoD, there are a lot of other opportunities for small businesses. So, this will be a useful webinar to look at something beyond just SBIRs.

Perfect. Well, thank you so much for your time today, and a really excellent webinar, and great information that our community can use. We will see you next week the same time.

Thank you!