Unknown Speaker  0:01  
Good afternoon everyone and welcome to today's webinar, university startups how I can make the most of funding and resources from the National Cancer Institute presented by Autumn. My name is Samantha Spiegel, I'm one of autumns professional development managers and I will be your staff host for today. All lines have been muted to ensure high quality audio and today's session is being recorded. If you have a question for the panelists, we encourage you to use the q&a feature rather than the chat feature. If you have a technical question or comment, please feel free to use the chat. Before we begin, I would like to take a quick moment to acknowledge and thank autumns 2021. Online Professional Development sponsor, we appreciate your ongoing support. And now I have the pleasure of introducing you to today's presenters. Dr. Monique pond is a program director in the Small Business Innovation Research Development Center at the National Cancer Institute. She manages a portfolio of grants and contracts to small businesses developing novel cancer therapeutics, digital health technologies and therapeutic devices. Additionally, Monique manages the development of new SBIR delt Development Center initiatives to assist small businesses in navigating the regulatory pathways for their technologies. She initially joined the NCI SBIR Development Center in 2018 as a Science and Technology Policy Fellow with the American Association for the Advancement of Science. Prior to joining NCI, Dr. Pons spent several years as a regulatory medical writer and a consultant at a small startup where she provided clients with regulatory support for FDA and Ema submissions. She was awarded a National Research Council fellowship at the National Institute of Standards and Technology where her postdoctoral research focused on the development of bio analytical tools. Monique earned a PhD in chemistry from Pennsylvania State University and a BS in chemistry from the University of Texas at Austin. st Kat Mishra received his education at University of Mumbai, India, earning a bachelor's and master's in pharmaceutical sciences. Due to his strong interest in drug design and discovery. He pursued and earned a PhD in medicinal chemistry from the Department of medicinal chemistry at the University of Kansas. During his time at KU, he engaged in structures based drug design to discover novel isoform selective inhibitors of heat shock protein 91 of his important discovery. One of his most important discoveries is a chemo type that potentially in selectively start potently and selectively binds HSP 90 Beta isoform, sparing other isoforms due to significant potential of this chemo type to treat certain cancers without adverse effects associated with previous HSP 90 inhibitors. Upon graduation sand cat continued his research at University of Notre Dame as a postdoctoral researcher to develop HSP 90 Beta selective inhibitors into therapeutic candidate to facilitate the commercialization Sam Cat and has co founded Grannis therapeutics and serves as principal investigator. The company has been awarded and SSTR phase one grant for lead identification Studies. Welcome on, you can send cat I will now turn it over to Monique to begin.

Unknown Speaker  3:15  
Hey, great. Thanks, Samantha. Thanks, everybody for joining today. Let me just pull up the slides here. Okay. Are you able to see the slides now? Yeah. Okay. All right. So So Thanks, everyone for joining us. And thanks to Smith and Autumn for having us here. I'm joined also by SceneKit Misha who will talk to you from the perspective of being an entrepreneur and using some of the resources that are at NIH to help his company and help develop this technology. So I'm going to start with just an overall view of the SBIR STTR program. It's it's quite a bit larger than just NCI or NIH even itself. So this is a federal program that involves 11 federal agencies actually that that have SBIR programs, including the Department of Health and Human Services. So within NIH, there's 27 different institutes and centers, one being the National Cancer Institute. And of those 24 actually have SBIR and STTR funding. So much of what I'm going to say today applies to any Institute you might be applying to at NIH, but I'll point out a couple of instances where you should talk to a program director within the particular institutes that you're applying and for a couple a couple of details are a little different between the 24 Institute So this is a congressionally mandated program, it's a set aside a certain percentage of a particular agency's budget. So for SBIR, this, this percentage for fiscal year 2020, as well as 2021 is 3.2% for SBIR and STTR is 0.45%. So what this means last year for NIH was roughly 1.2 billion was set aside solely for funding, the work done by small businesses within the United States. So FDR came about and was really made possible by the by Dole Act of 1980. So if you're not familiar, this Act made it possible for entrepreneurs, such as yourself to have inventions developed new IP, through the support of federal funding, but not have the government take any of that IP. And so that really paved the way for the SBIR program. And we have universities, small businesses, as well as nonprofit institutions that have benefited from from this change in policy. So one question I often get asked is, by people who are new to the program is should I apply for SBIR STTR. And really, the two programs are very similar. As far as the criteria I'll develop, I'll discuss later on how they're reviewed. The award sizes, they're, they're the same between the two programs, what it really comes down to, usually for most people is the PI's employment. So the PI on the grant, if they are primarily employed by a university, then it's best to go the STTR route, because they can maintain that primary employment and still apply. For SBIR, the pie needs to have primary employment, so at least 51% at the small business. And often that's not, that's not something possible that most universities allow. So that's kind of the the purpose of the two programs. So in 2018, my office did an economic impact analysis. And we were trying to determine over the previous decade, you know, we know how much government funding has gone to small businesses that we are trying to determine from this small businesses, you know, what has come out of that? How many different products have made it to market? What about their revenue for the companies as well, as, you know, as they grow all the additional people that now they hire, and then you know, those people go out into the market and purchase things, etc. So, you know, we were, we were pleasantly surprised that, you know, quite a few products have resulted directly from the NCI and this is just the MCI to these figures, not the whole NIH, and in quite a bit went out into the economy. And, you know, this, this, this kind of demonstrated for us that, you know, supporting small businesses is really important, and it can lead to much bigger things such as job creation, follow on sales, etc, that sometimes people don't necessarily think about or equate when they're getting those first few grants. But we've had several companies that go on either to, you know, depending on those technologies, and companies just grow within themselves, some companies will be acquired by a larger company, when they get to a certain, you know, value inflection point, and then some companies go on to license their technology out as well. So now, I want to talk a little bit about the funding process. And this is, again, this applies to all of NIH, when I'm showing here. And, you know, I like to warn people a little bit that, you know, it is a long process, working with the government and from, you know, the, the deadline of when you apply to when you could potentially have money in the bank is usually somewhere between six to eight or nine months. So if you if your small business needs money next month to pay salary, then you know, this definitely isn't going to help with that. But if you are thinking long term about your business and how to either start or grow it, that's where these grants can can come into play. So if you're familiar with the RSA one or you know other more academic grant processes that at NIH, it's very much the same process as far as it will go out for peer review. It'll be judged your grant application will be judged on five review criteria, this the same ones for our ones. And then you'll have a study section, you'll receive an overall impact score if if your grant is discussed this similar to our ones, it goes out to three reviewers, they give their initial scores, and then the top 50% of grants are discussed and receive an overall impact score. As far as eligibility for either SBIR STTR program, you know, I like to just emphasize that the award always goes to the small business, so it doesn't go to the pie or to the university. But you must have incorporated your small business, it has to be organized for profit within the US. And then the work that you propose within the grant itself should be performed within the US as well. So one of the questions I I often get is, you know, what, if you want to hire a contractor to do a certain set of experiments, and they are located outside the US, but it is much cheaper and much better price to do that, versus us a contractor within the US. And so I just want to emphasize again, that this program is meant to support and encourage businesses in the US. So you should even if it's more expensive, you should use a contractor within the US. And then I should say, too, with SBIR or STTR, even though the award goes to the small business, you can have a sub award to a university. And so, you know, definitely a significant amount of these grants. Through sub Awards, the money does end up at the university to support some of the research ongoing there. So if you're interested in finding a funding opportunity announcement or FOIA, how can you find them if you're interested in any federal agency, so any of those 11 that I showed at the beginning, you can go to grants.gov. And you will be able to search any of the grant opportunities that are available. If you are interested in focusing just on NIH, then you can go to either as the other two links that I'm showing here, on the bottom left and bottom right, and you'll be able to search, you know, even outside of NCI, you'll be able to search all 24 NIH institutes that have SBIR and STTR.

Unknown Speaker  13:11  
So I'd like to discuss some of the current funding opportunities. Now. And again, like I said, at the beginning, IP is always retained by the small business now, thanks to by dou x. So you know, if you get one of these grants, you develop new technologies, your IP changes. That's great. By all with the USPTO. And you know, the government is not interested in taking intellectual property through these programs. So I also want to point out, it's not alone. So I keep saying, grant, but sometimes it can be a little confusing. The Small Business Association does provide loans to small businesses. But this is separate from that. So this is a grant that doesn't need to be repaid. And what this means is if your company receives one of these grants, you can go out and kind of use it to market or talk to an outside investors. They often like to see that the company has non diluted funding, it's called. So so that is one one benefit, aside from the money of course, from from getting one of these awards. So it is a three phase it's referred to as a three phase program. This is not to be confused with a clinical trial phase one, phase two, phase three. So that's that's separate but it is still called phase one, phase two, phase three. Phase three is when you you've now your company has progressed and is now has outside funding solely it's not using any more SBIR or government funding But most companies will start at the phase one. Now for NCI, this is up to $400,000, for phase one, and it's usually proof of concept experiments. So for example, if you are developing a therapeutic, you'll most likely be doing some optimization of that therapeutic, maybe you have a lead, maybe you are improving the solubility, trying to work out the stability a bit, and then you're doing some in vivo animal experiments in your phase one. So the phase two, this is up to a $2 million grant. And this is where quite a bit more expensive. Research is done. As far as your animal experiments, going, if it's a therapeutic, you're doing your ind enabling experiments for your phase two. And then, after your phase two, we have what's called a phase two B bridge award. And this is our largest award of up to 4 million. And for this award, companies will actually go out and get matching funds from investors. And so it's kind of meant to be that bridge between a company being solely funded through the government and then a company, you know, moving on to the private sector. We do have what's called a fast track award as well. And that's where companies apply for both phase one and phase two. At the same time, we're up to 2.4 million. But most companies, I would say, come in and start at the phase one. And now this is one of the areas I will say if you're interested in other Institute's at at NIH, definitely check with that particular institute for their maximum award budget allowed because it the 400,000. And the 2 million will change a little bit depending on which institute that that you're working with. So here, I'm just showing a list of all the different options. The one at the top, I would say is by far what is used the most it's called the omnibus solicitation. There's three receipts dates a year, so you January, April and September. And these are investigator initiated grant applications. So the particular subject and what you're proposing, that's up to you, the entrepreneur. If you go down to the contract solicitation, the second from the bottom, I do just want to point this out, because it is a little bit different from a grant, it's it's a different mechanism that has a little bit more, I would say specificity from the government on what exactly you're investigating. So each summer, NCI will put out a list of topics, usually around 15 or so. And if you're working in one of those topic areas, then that can be a great way to to apply to a contract solicitation instead of the omnibus. And if if you're not working in any of those areas, you know, that's okay. Like I said, most people come in through the omnibus solicitation. So before I turn it over to Stan cat, I wanted to mention two brand new awards that we have specifically aimed at universities, and research and entrepreneurs there. So the first is called the innovative concept award. If you are familiar with SBIR, you know, these days, it's pretty competitive to get to phase one, that you have to have preliminary data, even for that that first award. And so this is really meant to be for really innovative ideas that are prior to having preliminary data. So if you have a particularly we call them high risk, high reward technologies, if you have a particular idea that could really be a game changer for a particular area. And if you're working in either rare or pediatric cancers, you know this, this might be an option for you. So there is a free webinar coming up on March 4, if you want to learn more about how to apply and what NCI is looking for there to be competitive. And so the second new funding opportunity we have it's called the small business transition grant. And this is meant to be for PI's on the Grant who are early on in their career. So we say within eight years from your terminal degree, whether that's a PhD or MD etc. Or masters for engineering So, so early stage career researchers, people who are working in, in academia, now, maybe they're a grad student, maybe they're a postdoc in some of these labs. And they're developing a technology working on it. And they eventually want to get it out into the clinic. And so this award is meant to support kind of that transition, if you will, if you're familiar with the key 99 transition on the academic side, it's similar to that. So you're, the award will be a fast track. So a phase one STTR, where the pie will stay working at the, at the university. And then for the second part of the award, the the phase two, the technology as well as the pie now moves to the small business. And their employment is been primarily at the small business during the phase two. So this is one we're pretty excited about, we've heard a lot from universities, that it can be really challenging to go from phase one to phase two often. And to make that leap, if you will, from from STTR, to to SBIR. And so we hope this will be you know, a way to kind of support that transition for both a grad student or postdoc who is interested in becoming an entrepreneur full time, as well as technology being able to move. So with that, I will turn it over to San cat, take it away, and just let me know when you want me to change the slide

Unknown Speaker  21:44  
next morning for the opportunity to share my experience about starting a company applying for the STTR award and receiving the award. Next slide please. So before I begin sharing my experience about the award and starting company, I would like you to know a little bit of background of what motivated me to stay back in the lab, I got my PhD and and developed the technology that I discovered during my PhD into you know, a therapeutic options for treatment of cancer. So during my graduate school, I was working on a protein called heat shock protein 90, shortly SSP 90. So we were making inhibitors of each after 90. It's a significant anti cancer target, because it is involved in maturation and regulation of greater than 200 proteins. Many of these proteins are involved in signaling cascades in the cell growth and proliferation, which makes it a great target for anti cancer drug development. And there are four variants which means have just been it called ssnit Alpha genetic beta genetic four and try upon which differ a minute ly in their structure and their function in the cell. Next slide please.

Unknown Speaker  23:21  
That's just been it was a big target for in last two decades. If you look in PubMed, you'll find 4500 publication relating to HS Canetti with cancer alone. Because of the interest in HFT 98 In compounds, entered clinical trials. Around 130 clinical trials were conducted using HSP 90 inhibitors. Every big pharma had a program developing and testing it in amateurs. Unfortunately, the developer just in anti limiters started failing and phase two and phase three, because of safety issues, and dosing challenges. So off note, all the inhibitors that have developed, they were binding to all four isoforms of HSP 90. So, in essence, these inhibitors are perturbing all 200 line proteins at once. And recent literature reports indicated that HSP 90 Alpha inhibition could be the real cause of the safety and dosing challenges that were observed in the clinical trials. So as a part of my PhD, I also focused on development of HS kinetic beta selective inhibitors and I discovered the inhibitor that inhibited just it's just been anti beta and spared all other isoforms potently and selectivity. Next slide please. So the discovered anyone ters offered a lot of advantages over the previous three screen just connect inhibitors. So this can avoid the adverse effects that were seen previous with the previous inhibitors, such as ocular toxicity and cardio toxicity. lower dose of estrogen anti beta inhibitors may be required, because it's only inhibiting one isoform. And it can also avoid the induction of HSP 90. In general. We found that unlike previous inhibitors, it just been anti beta selective inhibitors were greatly inhibiting growth of breast cancer, colon cancer and looking at cancer lines. So previously educated innovators were inhibiting growth of all types and forms of cancers. So what we had was a good candidate compound, but it wasn't a drug like. So, there were some studies that needed to be performed to make it drug like and commercializable. First was to modulate the structure of the candidate compound to have suitable solubility and suitable metabolic profile. So in order to facilitate facilitate the formulation and achieving a good concentration for therapeutic benefits, and next would be the preclinical studies with the developed or modular structure in the in vitro and in vivo models to establish the drug metabolism pharmacokinetics and be efficacy in scenegraph cancer models. Next slide, please. So, to commercialize the developed technology, we needed to incorporate a company along with my PA, we went ahead and registered an LLC in 2019. So when you're incorporating a company, you have to make a decision of whether you have to go for an LLC or a corporation. So LLC is the easiest one to register and get going with. And once you register you will get articles of organization and you will also have to agree to an operating agreement which decides the day to day operation of the company you will get an Employer Identification Number ein which which is used for further registrations. So for SBIR you need to have five registrations as it SBR NS STTR. So after incorporating the company getting the EIN getting a DUNS and Bradstreet number is the next step. And then you have to register in SAM, which is system Award Management, which you have to register for in order to get our apply for grants apply for federal grants. So for illustration of Sam, you'll need a DUNS number, and E and EIN. And it is worth noting that Sam can take some time. So for me, it took four weeks, it can take up to six weeks. So the applicants should be prepared and planned in advance with the application deadlines in mind. During Sam application, you will get an MP and pen which is code that you will have to use that you can use later for other governmental audits. Next registration is with SBA. And then the other restriction as with the grants.gov. This is required for Health and Human Services as we are and the first restriction is with your comments. So after you have all four or all five credentials, you can apply for SBIR or STTR. Next slide, please.

Unknown Speaker  29:12  
Yeah, thanks. Thanks. I'm glad that you mentioned the registrations. And correct me if I'm wrong, but I think none of them are extremely time consuming, at least compared to putting together the grant. But as you mentioned, each each can take quite some time. So I usually advise people they give themselves at least two months before an application date to make sure they get through all five. But how much time did it take you to you remember from start to finish for all of them. For

Unknown Speaker  29:44  
me, it was a month and a half around 45 days. Yeah, and I should mention that it was also around Christmas time so so it could take shorter than that.

Unknown Speaker  29:57  
Yeah, so

Unknown Speaker  30:00  
Yeah. So, I was also working on the grant submission. So writing was going on, that really do all the registration. So, in the grant, you have to have specific aims or defining your studies that you're proposing. In my case, a small molecule, which was, you know, at the candidate stage, I needed to propose late stage medicinal chemistry to modulate the solubility and metabolic profile of the compounds. And then taking the modulated compound. And, you know, as I previously mentioned, de risking and validation of the identify candidate and dmpk. And in vivo studies, the proposed studies need to be focused on like the academy grants. And it needs to have programmatic, pragmatic deliverables. So, you have to define when which experiments will end and when it would start, you need to plan budget in advance, because there is a work distribution that needs to happen between company and the university. And we'll get what and was going to do, how much of the assigned work. The written grant can be submitted, using either comments, assist module, and or grants.gov, or workspace. If you're working, or submitting via University University may also offer a consultant that can help you with the submission of the grant. Next slide, please. So, after the review, if your grant is considered for award, you will be asked to submit the organization review document. So the document will ask for multiple. It has a lot of requirements. So these are some of the major ones, you need to provide an org navigational chart, really defining the hierarchy of authority who's making decision and who's overseeing the day to day operation of the company. You need to provide provide documents to prove financial stability. If you have, you know, secured some funds outside of the SBIR that you're applying for, or if you're if you can sustain the company, even if you don't get the SBIR award. You also need to provide financial statements like audits if you have, and you need to provide the process in place for accounting for all the purchases and transactions of your company. And if you have lapses, you have to provide all these documents, and office having an office space is a requirement for us together. Because me if I'm wrong.

Unknown Speaker  33:06  
So you're you're correct about the office space for SBIR STTR. year, the company doesn't have to have space when you apply. But you should have a plan. So for example, a lot of universities have incubators, that will leased space to companies. So you should have a plan in your application that they if you were to be awarded that you would be able to start leasing space. And it doesn't have to be an incubator, but that's often what people use, I think. I think you're at an incubator. Are you seeing cats? Yes, I am. Yeah, yeah. So that's a great point, though, about the the space for the work actually be made, that the company has test space that that's not your home address either or the academic lab space.

Unknown Speaker  34:03  
So also, additionally, you need to provide policy documents that describe the personal policies and procedures, policies about establishment of salary levels, time and effort, who's going to report to whom and how the time invested will be tracked? Who is authorized to approve the vacations and leaves? How are the travel policies are regulated. You also need to have written policies on acquisition, maintenance and disposal of inventory, materials and documentation. And you also need to have a procedure in place to prevent duplication of purchases. So, funding agreements certification is a form that you need to fill have agreed to and sign an agreement between you and the awarding agency that you meet all the requirements for an SBIR award. If you have other subcontractors or university involved in case of STTR, you need to have inter institutional agreement established between all the involved parties. So that, you know, the distribution of the work and, and money is properly handled. Next slide, please. So, in order to conduct the proposed experiments, you can go for a lab space. If your university has a incubator space commercialization building, they will offer you a space that you can share with others. If you don't need equipments that are not in the shared lab, you can go for your own lab space and purchase those equipments. When having your own lab space, you need to make sure that it meets all the safety requirements. And I mean, last week for chemistry is different from last face from biology. So make sure you select the space that adheres to all the safety requirements. Also, you need to maintain Material Safety Data Sheet for all the reagents that you buy all the chemicals so that it is available for the safety personnel or fire department for them to access. You can buy equipment from different vendors. What I found initially was for closers, I was surprised to learn that eBay is also an option. So a lot of people are selling password, which can be really expensive on other websites, for very cheap, you can also make off, make an offer if you don't like the price, this was something I did not know earlier, I got some customers that were very expensive, but I got it for dirt cheap. So if anybody's interested. Next slide. So onboarding, in case of small molecule drug discovery, it's a very long process. Audience, it's the product is not even close to ready for commercialization. So, in order to facilitate you or assist you in commercialization, you will need expertise and expertise to help you commercialize the technology. So, I did not have a business background. And you know, initially, it was a challenge to understand all the terminology of business terminology, when I was presenting, virtual capitalist, the simple present, whenever I presented it to VCs, they had some terminologies that I didn't understand. So, we have actually onboarded and business executive who is overseeing all the business planning and, you know, planning the fundraising. So, it may not be the case for medical device company, you can, because it is ready to market, you can just go out and ask for the money. VCs are okay with the business plan that you have proposed. You need to have a board of directors in place that is going to oversee all the big business, big business decision making all the it's going to oversee the CEO is going to oversee the employees. So in our case, it's CEO, another pie and a third person who is neutral. So it's always good to have three individual parties. You know, presenting different representing different areas of the company. We also are onboarding Scientific Advisory Board members who are expertise. We have expertise in clinical, regulatory and preclinical development. So you need to have employment contracts in place every everybody that you're onboarding needs to reflect all the resources that everybody's investing and what compensation do you get for each and every scenario? what if scenario, what if the company gets sold out what if the company gets taken or what have you sublicense? At me? It needs to be defined in the environment contract so that you don't run into problems later. Next slide, please.

Unknown Speaker  40:09  
Yeah, no, I'll just add, you know, I think that's great that you bring up this this advisory board and onboarding kind of additional people, after you get started, I would say a lot of our companies, especially phase one, when they get that first award, as often, two, three scientists, who develop the technology, and that's it as far as the company, and then as they receive, you know, awards, they, they kind of grow their, their advisory board or in their additional support. Some companies also will hire consultants in a particular area. So for example, a statistician or something to advise on the particular experimental plan for, say, your face to grant. And these are things you know, these people, they don't have to be full time employees at the company or anything like that, you know, it can be mentors, maybe you meet at the university who are willing to serve, or, or maybe through other connections that, that you have. So something to keep in mind as you move along and grow your business, as think Edison.

Unknown Speaker  41:25  
So next up, are you can do it sounds good to you why onboarding, is the license acquisition. So since the technology was developed in university, you need to acquire the license to get a patent, we are that university. So it can be a long process, or it can be a short process, depending on the technology, the university, it's, it's, it's a very unique experience, it's been at least for me, because this technology was developed at KU, and then it was not related to train. So for us, there were two universities that were involved. But at the end, key you and Notre Dame have entered into an inter institutional agreement, so that we only deal with Notre Dame one university. So as a part of acquisition, you will have a term sheet presented to you, which will include different parts, or clauses. So the first will be how much do you pay the University for a patent or acquiring the patent? For some universities, they will charge a lot of for license fees, and not ask or ask minimum equity in the company. And some university may not ask for a lot in licensing fees, but they will ask, you know, significantly, not significantly higher than the other university can be equity term. So you need to just see if those things are balanced. Another part of the agreement is royalty fees. So university may ask royalties from the sales of your product when it's marketed. So that's a part of it. And then sub licensing fees. So if you decide that you're selling you, after acquiring, you're trying to sell the technology or sublicense it to a different company, maybe for a different indication, maybe for a different market. So a chunk of it will be will go to the university as of licensing fees. So you need to make sure that is aligned before or everybody's agreed to a number before the final term. There is a diligence involved. So when you acquire the license, it doesn't mean you get to hold on hold on to it forever. There is a term to license. So there are milestones that you have to deliver. So, for us, it's by certain time we have to take molecule into or submit an IND and then the second milestone might be, you know, go to phase one, go to phase two, a clinical trial. And then also there is a question of inventory ownership, which is defined in the term sheet is like who won't see in mentioned, if you discover the, you know, if if you declare something as a part of sub contract in the university, so there's ownership versus having rights issue that needs to be sorted out. And also you need to look out for competing patents. It could be from your own lab, it could be from a competing company, competing university that may have product in the same area. are, you know, same therapeutic, you know, technology. So whether you want to acquire those patents or not, it's up to you. For us, we have another patent, which we also are looking to acquire, so that it cannot be acquired by a different company. So make sure you cover all your competing patterns. And I discussed the distribution agreement earlier, if you have greater than one universities involved in finding of a button you need to have into AI in place. That concludes my part of the talk, I really want to thank NIH, NCI for conserving our company for funding and giving it a boost. And I hope that molecule turns into it inhibitor that is, you know, that helps people.

Unknown Speaker  46:00  
Thank you. Thanks, thanks. Yeah, you know, great point about, you know, if your technology is developed at a, at a university, most universities have a tech transfer office, and, you know, go talk to them and about your ideas and see what their process is, from my experience, you know, each, each university is a little bit different in their process, and has been kept mentioned about the different fees, those can really vary between universities. So, you know, definitely talk to the tech transfer office and, and see for that particular university, you know, what, what their processes what they require? Yeah, and I guess we've been talking about therapeutics a lot. So thanks, thanks for mentioning about devices as well. You know, at MCI and other Institute's, at NIH, we don't have a set. For our portfolio for the technologies we fund, we don't have a set percentage, like say, we're going to fund this many therapeutic companies and this many devices. For us, we really let entrepreneurs dictate, you know, what we find, so we try to fund grants that are really innovative, and really game changing. And since it's NIH, you know, that will have an effect on on patients and a positive effect. And so at NCI, obviously, it has to be cancer related, but it could be, you know, we find devices and in therapeutics, but we fund imaging agents, we find preventative cancer measures, we find a lot of digital health, actually, the last few years has become almost 10% of our portfolios. So, you know, think outside the box when you're thinking about what technologies you're you're developing. And, you know, if you're interested, you know, we're always happy to talk to you and and see if, if what you're working on could fit with the SBIR program. So we're going to save time for questions at the end for sure. So, so definitely think of all your questions happy to try to answer them. But before we do that, I'll just have a few slides here on how to get started. If you're thinking about SBIR STTR. There is a quite a large PDF, I think it's over 100 pages. It's called the SF four to four. And basically, it's instructions for each section of the application to explain what's required page limits, etc. So, you know, definitely take a look at that. I also encourage people, if you've never written in SBIR or STTR, you know, take take a look at some of the sample applications that are online. These are real grants that were funded by Nyad, the Allergy and Infectious Disease Institute, you know, some redactions has been done for privacy purposes, but they're real grants that were funded. So you can kind of take a look and see, you know, what type of specific games are people applying for in their phase one, versus what are people applying for with their phase two. So I think that can be pretty useful. You can also use NIH reporter to this will have an abstract and you can search any grant that NIH has funded previously so so you won't be able to find ones that have applied it and weren't awarded. But any any grants that's been funded by NIH, you can actually pull up this information so you can do a search in your particular area and see, you know, what other people are working on kind of what Stage in development they're at when they got their SBIR STTR. So my office has several PDS program directors and, you know, we we really encourage people to reach out to us and just an email with your specific aim. Well, before you even apply for your first grant, you know, we're happy to try to help you with the aims or give you advice on if you fit for, you know, the phase one award or the phase two, etc. So, so definitely send us an email and we'll set up a time to talk. We do have a program, it's a it's a free program called applicant assistance program for anyone that has not received an NIH SBIR STTR award before. And if you're accepted into the program, it's about 10 weeks, and each week, you will meet with a mentor who will not write the grant for you, but they will help you with all the different sections. The requirements, though, can walk you through the stages of all those registrations, same kid and I discussed. So it can kind of help you if you've never written one of these types of applications before, kind of get to having that first draft ready to go. So this is something that opens up three times a year. So we ran a new cohort before each of those three omnibus deadlines I mentioned. So definitely check out our website. For the next cohort. I imagine there'll be opening probably around March or April for then the September omnibus deadline. So if you're funded, definitely celebrate. It's quite an achievement. I think, you know, right now, as far as acceptance rates, I get that question a lot. So I'll just mentioned that. It's around 10%. For for phase one. People when they first apply, we do have a resubmission process. So if you're not funding on the on the first time, you can make changes and resubmit. And we do see those success rates go up to around 20 to 30%. So, but it is competitive, you know, for sure, just like I think everyone's aware of any NIH government funding right now. So definitely celebrate. And then, you know, within our office at NCI, we have several programs, I'm showing I'm here, I won't talk about all of them. But we have several programs that will help you kind of learn and grow your business on the business side of things. So So once you're awarded, you can check out those. We have also put together some some groups that to try to connect our companies and to have, you know, small businesses kind of interacting and growing their network with other small businesses. So for example, our peer learning and networking webinar, we will invite some of our awardee companies to speak on particular topics. So some of the topics we've had, we've had one on how to write a phase two grant successfully, how to write a bridge grant successfully, how to apply for a 510 K. So that's a regulatory pathway for FDA for devices. So different topics like that of interest to our companies. So I call it Nia, NIH, most, I imagine most people have heard of iCore. This is similar to the program that NSF started several years ago, and we took it and kind of tweaked it to fit what the needs were for life, the life sciences. So once you have that phase one award, you can apply to participate iCore. If you're accepted, we pay the fee. So you receive a grant to cover your I court fee. And it's about eight weeks long. You do several interviews. So you go out into the community, talk to people who might use your particular device or clinicians who might use the year therapy for their patients. And that's part of the program along with other trainings from Ichor instructors. Okay, so, one other program I'd like to mention in our office is called investor initiatives. And we started this as a way To connect companies, once they have an award with this connect companies that are ready to go out and start pitching to investors. So maybe you have this SBIR STTR award, but you've never gone out and talk to an investor, you're not sure how to do that. So this program can help. Again, it's a free program, we, if you're accepted, we do pitch coaching, to help you understand how to put together a pitch deck and how it differs from say, your more traditional scientific technical decks that you're, you're used to putting together. And then we also pay for you to go out to,

Unknown Speaker  55:43  
to conferences, and meet investors and pitch to them. So, you know, obviously, right now, everything is virtual, but in the past, we would, you know, physically send you to these events and pay for you. So that way you can start making those connections and, and relationships and hopefully, you know, gaining some of that follow on investor funding. Okay, so, you know, if you're not funded, you know, like said, definitely reach out to us first and talk to your program director and see what improvements can be made to your grant application, I'll cover three common pitfalls, that that we see, especially when people are starting out trying to kind of make the switch from writing are ones to the small business grants. Sometimes reviewers could be unsure of the significance of the problems. So it can be helpful when you think about your letters of support, you know, of course, you'll have letters of support from your team members from from your collaborators on the grant, but you want also for this mechanism and think, you know, bigger than that, think about where will your product eventually be used? So, so go talk to those people, you know, whether that's maybe a key opinion leader in a particular oncology field? Or if it's a, if it's a device, for example? And say, say it's an imaging device, how is that going to fit into? We call it the current clinical workflow. So if it's in a hospital, for example, you know, have you thought about the size of it, will it fit in, in a current operating room, things, things like that. So go out and talk to people who work in these areas, and, you know, have them share their excitement, and then a letter of support, and you can include that in your grant. So, you know, sometimes reviewers, maybe they didn't quite understand the proposal. You know, I always encourage people to to, once you have that final final application ready to go before uploading, you know, have someone who's not, not at your small business, who's not in your academic lab, have them read it and, and just kind of see where there might be some confusion or what they come away with, if they're, if you've really made clear what, what you hopefully did, which is, hopefully you know, the innovation. Again, you always want to focus on this future product that you will be developing and where it will fit in the marketplace. Make sure that all of that, is that a clear story for reviewers to follow. Okay, and third, this is something we see particularly in brand new startups, I mentioned that a lot of our companies who start with a phase one, you know, it's just a, it's a couple people on the team. And sometimes reviewers feel like you know, that the team's not necessarily qualified to be taking a drug all the way to the market, for example. And in to kind of augment this until you're at the point where you're hiring, say, a full time business person that your company, you can hire a consultant. And, you know, as I mentioned earlier, there's a lot of different areas, people will hire consultants, on their on their grants, or, you know, it can be someone part time as a company if you if you wish, or it can be a collaborator that you meet at the university with expertise in a particular area, but kind of think outside the box of, you know, it doesn't have to just be a full time employee at the company in order to be part of your team. And also, multi PI teams are are definitely allowed for this small business grant. So lastly, I would just like to mention, you know, we have a lot of free events through our office If you can either check out our webpage or we do a periodic newsletter. So if you sign up for that, then you'll hear about things like when the applicant Assistance Program, when that date opens for new applications, if we have a new program that comes out, you know, that will be in the newsletter. And then along with the reminders about when the omnibus deadlines are and etc. So with that, I think I will stop sharing here. And that way.

Unknown Speaker  1:00:37  
All right. Okay. Yep, I can see the chat box now. So. So if you have questions, definitely put them in the chat box. It looks like we had a question about the investors Initiatives Program. So that that program in particular, yes, it's within NCI. But other Institute's do have have similar programs. So definitely talk to your program director at the particular institute, and see what what types of programs they have. And because this does change, too, so for example, the applicant Assistance Program started a couple years ago, and when it started, it was just in CI, and then it was working so well, that other Institute's during dawn, and now, I think it's like eight or nine Institute's participate in it. So so things can can change those definitely check with the particular institute.

Unknown Speaker  1:01:36  
And then I saw another question in the q&a about the slides being available. So yes, we are we did record this session, and we will have the slides both of which will be available in the autumn Learning Center, probably by end of day, tomorrow, Monday morning at the earliest. So you'll have access to all of the links that Monique and suncat were sharing with us as a resource. So don't worry about trying to jot down all of those if you didn't save them all, we'll have that for everyone.

Unknown Speaker  1:02:04  
Yes, yes, for sure. Well, thank you, I had a I had a question for you. You know, I I'm on the side where I get to talk to a lot of small companies. And it's fun. And in previously, I worked at a small company, but not overlapping with my postdoc. So I did those two separate, separate things. So how do you juggle doing both at the same time? And I mean, go into the company going to the university? Or do you? Or do you find that they kind of work together?

Unknown Speaker  1:02:37  
No, I mean, initially, it was hard to manage. But then I found symphony, like, I can contribute few hours there, contribute most of my work at the university, you know, identify studies that I need to complete in this week for the company, and then studies for, you know, the postdoctoral duties. Yeah, it was, like initially incorporating then, you know, talking with different collaborators, and, you know, onboarding, it has taken a lot of time. But as we move forward, it's, it's, you know, other people are also helping, and bars are there, they read the documents for me. So it's, it's getting smooth, but yeah, initially, it was a lot of management of time and resources.

Unknown Speaker  1:03:31  
And making that switch from the LLC to changing everything for the corporation. I will say we have a lot of companies do that. So I guess you mentioned LLC is the kind of easiest way to start. And then how, what made you make the decision to switch. So

Unknown Speaker  1:03:47  
in order to grow rapidly, we need to get investments. And, you know, the face to SB fer mean me, it may take some time, and, you know, for me to start working at the company needs some fun. And so, to attract the investors, corporate structure is preferred. And, yeah, that's, that's what the driver was behind the conversion. And also have the exec executive have his compensation. So he's also not the part of the structure of the company. So the corporation structure facilitates all of that.

Unknown Speaker  1:04:37  
Yeah, that makes a lot of sense. Yeah. And it can take a while to get investors and, and often it's a series of conversations over sometimes years. So it's always good to start that early. Especially with therapeutics, you know, it some of our companies that are working on devices will be able to get all the way to A market with their device solely on government funds. But as you know, therapeutics are just way too expensive. That the grant money is meant to get you hopefully to the point where you have data that you can show investors and get those those funds for clinical trials. And

Unknown Speaker  1:05:21  
yeah, I mean, at some point, you need to stop thinking like a scientist and start thinking what the investors want. So, you need to put your company hat on and start thinking, Okay, if I do this, investors will be interested, if I do this study, and you when you go to conferences, you will get the feedback from investors about what they want to see. So I have had questions of where some experts were present at the conference from VC firm, which were, which had biotech background. So they had specific questions about the science as well. And then specific questions about the business side of the development. So yeah, it's going to the conferences actually prepares you a lot, and helps you in business planning.

Unknown Speaker  1:06:19  
Good. Are there any particular organizations besides autumn, of course, that, you know, you've found useful when you're starting out, or you wish you had known about earlier on when you're trying to kind of make this leap to starting your own business.

Unknown Speaker  1:06:35  
So organizations, if you talk to be commercialization, you know, wing of the university, they have the network of investors, which are alumni of the university. So for Notre Dame, it's a big network. And they can add act as an angel investor, and they can, you know, help you connect with different alumni guys do have their own network and big biotech hubs, like San Francisco, Boston, so the university can help with connecting with investors. Apart from that, different states have different initiatives. So Indiana has pi a crossroads, it's a conference consortium of experts from industry, invert investors from state coming together, and, you know, focusing on the upcoming technologies, so they have events ongoing. So you know, people can look at look for consortium like this in their own state. So, my experience is around Indiana, so they also have an economic development forum. So if you receive SBIR, you're also eligible for grant matching funds. So for phase one, it's up to $50,000. So that's additional money on top of the SBIR award that you can utilize for the development.

Unknown Speaker  1:08:09  
So yeah, that's a great point. I think a lot of states actually, not all states, but I've heard a lot of states have those matching funds. And, you know, that's something else you can put in a letter of support that says, you know, because the government always likes to see, okay, you know, someone else wants to pension funds or match even, you know, a portion of it 50k can certainly be an additional boost there, especially when you're starting out.

Unknown Speaker  1:08:36  
No, I totally agree. And, like University has Demo Day, so you, you can go and pitch to a different masters. So it used to be physical, but now it's gone virtual. But when it was physical, it was on bio.org has events, ongoing automation. And American Chemical Society also had webinars on how to start up your company, how to write a business plan, so they had a series of how to start a biotech company. So should be online available if people are interested.

Unknown Speaker  1:09:20  
Great, great.

Unknown Speaker  1:09:23  
I think that covered the questions that came through to Monique or suncat to either of you have any kind of last parting pearls of wisdom, you want to make sure that our attendees know and hear or are we I know you guys have already shared so many but just any final closing thoughts

Unknown Speaker  1:09:42  
I know I would, I would say just you know, come talk to us. You know, I shared this slide with all the program directors you know, we we really are interested in hearing from people you don't have to have started your company or anything like that to come just talk to us and you know if you're interested in and learning more, you know, we're happy to, we're happy to talk to you.

Unknown Speaker  1:10:06  
Yeah, I would just say it's a great resource. People should, if they believe that technology is where they should apply, and not only about it also opens up the door to different resources that NIH offers. So it's, it's just an ongoing resource that you can access different initial investment initiatives. You can get feedback from FDA, you can own your technology. There are so many things that are available to you once you are logged in, so you do not have

Unknown Speaker  1:10:41  
Well, thank you both so much on behalf of autumn, I would just like to thank you for the informative discussion and all of our attendees for joining today. We already talked about the recordings, just remember that will be in the my Autumn and Autumn Learning Center by the end of the week, and a survey will pop up when you close out of this session and we appreciate your feedback in advance. So with that, I wish you all have a good rest of your afternoon and I look forward to seeing you again soon. Thank you

Transcribed by https://otter.ai