Inside Cancer Careers

Small Businesses are BIG at NCI

07 Sep 2023

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In this episode of Inside Cancer Careers, we hear Michael Weingarten, Director of NCI's Small Business Innovation Research (SBIR) Development Center. Mr. Weingarten shares the various programs and resources available through SBIR. We then hear from Dr. Margaret Jackson, Co-Founder of BYOMass. Dr. Jackson recounts her experience of becoming a scientist and a small business owner. She also provides insightful tips on how to effectively apply for a small business grant. Show Notes Michael Weingarten, MA NCI Small Business Innovation Research (SBIR) Development Center Small Business Transition Grant Small Business Applicant Assistance Program Innovation Corps (I-Corps) Investor Initiatives Presidential Management Fellowship NASA Technology Transfer Program Ad: NanCI by NCI Margaret Jackson, D.Phil. BYOMass The Capital Network Grants.gov Small Business Administration eRA Commons SAM.gov FreeMind Group Eva Garland Consulting Royal Society Fellowship Your Turn The Whale (movie) A Distant Mirror by Barbara Tuchman [UPBEAT MUSIC] OLIVER BOGLER: Hello and welcome to Inside Cancer Careers, a podcast from the National Cancer Institute. I'm your host Oliver Bogler. I work at the NCI in the Center for Cancer Training. On Inside Cancer Careers, we explore all the different ways that people join the fight against disease and hear their stories. Today, we're talking to Michael Weingarten about how NCI supports small business develop technology and agents to end cancer with grant mechanisms. After the break, our guest is Dr. Margaret Jackson, the CEO of BYOMass, a company that's been supported by a grant from Michael's center and which is developing therapies for one of the big problems that many patients with advanced cancer face. Listen to the end to hear recommendations from our guests for interesting things and where you are invited to take your turn. I'm a cancer survivor and as I went through my treatments, chemo, surgery and radiation, and now long-term hormone therapy, I became aware that everything that was used to manage my cancer was made by a company. Sure the research behind it may have had its roots in academia but to get from that bench to the proverbial bedside, a commercial entity had to get involved. There are rare exceptions, some experimental therapies maybe, but even here more often than not, companies are involved. It's for this reason that the NCI funds innovation in the business world. To talk with us about that is Michael Weingarten, the Director of the Small Business Innovation Research Center at NCI. Welcome Michael. MICHAEL WEINGARTEN: Thank you, thanks for having me today, I appreciate that. OLIVER: Yeah, before we dive into the SBIR work, I'd like to ask you about your own path and your career. How did you come to do the work that you do today? I understand that you started by studying political science at Northwestern, isn't that right? MICHAEL: That's right, that is right. Yeah, so, I did my undergraduate work at Northwestern, political science. I then actually went to Columbia after and I studied international relations. And I went into my career thinking I was probably going to go into the foreign service. OLIVER: Huh. MICHAEL: And that that was going to be my career, focused on U.S.-Russia relations. OLIVER: Interesting. MICHAEL: But as things changed, for many of us, I had the opportunity when I was at Columbia to join the government in a management training program called the President Management Fellowship, which is an entry-level program for folks to get into the government. And I started at the State Department actually for about a year and then I was able to do a rotation over to NASA in my second year. And NASA actually ended up being where I spend a good part of my career, I was there for about 15 years. And I had the wonderful opportunity when I was at NASA to actually build NASA's Technology Transfer Programs. NASA is famous, probably when you think of technology related to NASA maybe you think of Tang and you think of Velcro as famous spinoffs from the space program, there've been many of those. It was my job at NASA to identify some of the most valuable technologies that NASA was developing and to then find private sector collaborators to license the technology and then to commercialize it for other applications. And I enjoyed that job very much. I had the opportunity to create a marketing and business development program when I was at NASA and while I was doing that, the Deputy Director of the NCI at the time happened to see some of my work and she was quite interested in really reinventing the program at the NCI for the Small Business Innovation Research Program. OLIVER: Uh-huh. MICHAEL: So she was able to bring me over back in 2005 and it was really a unique opportunity to really take a clean look at how the SBIR Program should best be managed. And I was given a great opportunity to actually take a step back and really reinvent the program here at the NCI. That's been a lot of fun. I've been doing that for the last 17 years now. OLIVER: So tell us what is the SBIR Center do? It funds small business but how and why? MICHAEL: Yeah, so the way the program was actually set up it's a program that Congress set up back in 1982 and the goal is to fund small businesses to meet the mission of the agency it's a part of. So our goal as part of the NCI is to fund a whole range of cancer companies, cancer-focused companies, really cutting across the whole spectrum of technology development that the NCI supports, so that includes drug development, devices, diagnostics, digital health, and also research tools. And we work closely with our colleagues across the NCI to identify emerging technology areas that are high priority for the institute. We come out with targeted funding opportunities in those areas, encouraging companies to apply in those areas. But we also, actually the real opportunity in the program is for companies that are working in cancer research to apply in areas that they're pursuing. We fund most of our projects actually through an omnibus grants funding announcement that is wide open. And if you're a company that's engaged in cancer research, you're likely going to fit within the goals of the SBIR Program. Our budget this year, actually, it's $200 million so it's a significant budget. And our goal is to move as many of these early-stage companies that are developing promising cancer technologies to move them through pre-clinical development into the clinic and ultimately to get those technologies out to patients or to the research community as a whole. So we offer funding to do that but we also offer a whole range of other resources that our companies need to be successful. OLIVER: Yeah, I want to get to those in a minute but why does a company apply for this particular source of funding? Obviously, funding is good, everybody needs it, but why SBIR instead of, for example, angel funding or venture capital or other sources of money? MICHAEL: So what's really cool from the company's standpoint about the SBIR Program is it's non-dilutive funding. We don't take any sort of an equity position in the companies that we fund. We fund projects through either grants or through contracts but we don't get any percentage of the company. We also don't get royalties back if the technology's successful. And the IP is owned by the small business, so it's a very attractive program for companies, new startups in particular, that are developing a technology. But if you look across our portfolio of companies, we fund all the way from startups to more mature small businesses, so it's a very wide based portfolio. OLIVER: Now, if I recall, you have two core mechanisms, the SBIR and the STTR, is that right? MICHAEL: That's right. So the larger of the two is the Small Business Innovation Research Program. The percentage is the dollars that go to the program are set by Congress. But 3.2% of the NCI budget is set aside to go into the SBIR Program. That's in the order of let's say, $175 million. And then the Small Business Technology Transfer Program is the sister program of SBIR and that program, around $25 million or so, that program is specifically focused on trying to transfer technologies that are being developed in academia to a small business. So the goal is to fund researchers, while they're still at the university, move those technologies out of the university to a company in order to enable their commercialization. OLIVER: Right. So the STTR application requires the presence of an academic organization, right, while SBIR can have that but doesn't have to have it? MICHAEL: That's exactly right, exactly right. OLIVER: Great. Alright, so you mentioned a little bit about other ways that you support people who are interested in entrepreneurship. Can you tell me a little bit about that? MICHAEL: Yeah, so if you look at kind of the typical company that applies for funding from us, many times, they're an academic spinoff. You know, you have a researcher at a university that's been developing a technology, they've developed some IP around the technology, they think there's some value there, so they're interested in seeing if there's a commercial opportunity. So the opportunity with the SBIR is a lot of times we'll be the first source of funding that a spinoff company will look towards when they're first getting started. So maybe they were able to get a little bit of university money to support the transition to that technology. Usually, it's not a lot, you know, maybe $100,000 or so. But what they can do at that point is they can apply for one of our early stage awards and we will, what we offer to every company that's applying to our program is we offer to review their specific aims ahead of time, and to give them some advice on things that they should be considering as part of their application. So we actually spend a lot of our time talking to potential applicants about their projects, advising them on how to write stronger applications. And if they're not successful, that sometimes happens with first-time applicants, we'll review their summary statement with them so that they can write a stronger application when they resubmit. And we find that actually, the second time people apply, their success rates are probably three times higher than the first time they apply. So it really does make a difference. And so one of the things that really separates the NCI from the rest of the NIH as a whole is we've actually set up a center whose sole responsibility is to work full-time with small businesses, and to advise them, but also to create these other resources that our companies need to be successful. So just as an example, we run a program, we call it our Applicant Assistance Program. These are for companies who have never received an SBIR in the past. And we actually will offer them a coach that will work with them over a 10-week period, and actually assist and advise them as they're writing their application. So it's particularly helpful for newbies who just don't really understand the NIH peer review process, don't understand all the different pieces of the application, and what they really need to put in into each of those different parts of the application. So we have found that the Applicant Assistance Program has been quite helpful to many of our companies, particularly companies that are made up of underrepresented scientists. We are very interested in increasing the numbers of applications from that community. We went back just this year, we looked at how successful companies made up of underrepresented scientists have been who have gone through that program. Across the NIH we've actually given 55 awards to folks in that community. But it's not just for that community, it's actually available to everyone. OLIVER: So I mean, that reminds me of how program officers work with academic scientists also to help them, you know, guide them through this process that is the application for an R01, for example, and you're doing the same for the business side. So peer review, you mentioned in passing, these grants that your center receives are peer reviewed, right? MICHAEL: Yes, so every application goes through peer review just like an academic application would. And if you look at the review criteria, they're actually going to be similar, in a lot of different specs to what the review criteria would be for an R01 or another academic grant. The one thing that really separates SBIR is, rather than being research-focused, the application is supposed to be product-focused. So companies as part of your application, you're supposed to identify what the product will be, and what the application of that product will be and we will also like you to identify if there's a specific cancer that that technology is geared towards. So thinking about the end application, also thinking about what the value proposition of the technology is, how is it an improvement over this current state of the art. It's important for applicants to really make the case about how their technology is going to actually move the field forward, move products that are going to be available for patients forward in terms of meeting a currently unmet need. OLIVER: Yeah, having an impact on the patients, I mean, that's ultimately, ultimately the goal. Now, you mentioned at the beginning that you were invited to NCI to sort of rebuild the center, reimagine it, what else is part of your center? MICHAEL: So we, in addition to the Applicant Assistance Program, I'll just mention a few other programs that we run for our companies. I think one of the most interesting programs that we offer to companies soon after they receive a grant or a contract from us, they become eligible for a program we offer called I-Corps or Innovation Corps. And what's really cool about the I-Corps Program is, in particular, it's helpful to companies that don't have a lot in the way of business backgrounds. So our I-Corps Program, I like to think of it as kind of like a business school boot camp in a way, because it's an eight-week long program. And it essentially teaches companies over that eight-week timeframe, how to build a business model around the technology that they're developing. So just as an example, they look at things like value proposition, what is, trying to really crystallize what is the unmet need that their technology can actually address. So over the course of that eight-week program, the way they do that is they actually go out and they conduct customer interviews. They meet with different people that are in the area of the technology that they're developing, and they get direct feedback from them and information from them on what need their technology can best meet. And then based on that, that really helps them scope out what the market opportunity is that they can best pursue and also what are the steps in actually moving that technology all the way from the earliest stages of development through preclinical development, ultimately into the clinic, and then ultimately to be commercialized. Because, as you know, in the life sciences space, it's a long pathway to develop a technology. It requires a lot of different parties to be involved. Funding is just one piece of that. We provide the funding but we also try to interweave all these other resources that our companies need and I-Corps is a really helpful program. We find that that program, in particular, helps set up our companies to be successful over the long-term, that's just one program. OLIVER: I-Corps exists in other institutions across the nation as well, correct? MICHAEL: Yes, so actually, I-Corps was initially started by the National Science Foundation, and they continued to offer I-Corps. What really separates their program from our program is we've really targeted towards life sciences, specifically. So we bring in domain experts, for example, in the areas of therapeutics, devices, digital health, and those domain experts really tailor I-Corps to the specific needs that life sciences companies have. NSF's program is much more broadly based. OLIVER: All of science, of course. Now your grant mechanisms are a stepping stone, they're not, that's not the only funding a company needs is a step towards this. So what happens after the SBIR grant or your STTR grant is finished? What do companies do then? MICHAEL: Yeah, so we understand that, you know, for example, to develop a new drug, depending on the estimates that you look at, could be $1.5 billion. Huge amount of capital required to be successful there. That's over the long term. So we try to set them up and move them as far enough along, get them to a key inflection point where they can raise additional capital. But we assist in that fundraising process from the private capital community. So the way that we do that is we run a program we called our Investor Initiatives Program. And the way that program works is over the last 15 years since I came to the NCI, I've been able to build a really strong network of relationships with the investor community. So I have relationships with the top venture capital investors from across the country, as well as the top pharmaceutical and medical device investors across the country. Once a year, we tap into a network of about 80 different investors. And we actually use them to help them review our portfolio. So they'll actually do almost like a peer review, except from the business side of our portfolio, and help us identify the top companies that we're currently funding in our portfolio. And typically, that's in the order of 30 to 35 companies out of our total portfolio. And then based on their recommendations, we will actually provide funding and coaching for those companies to then go and present at private investor events, events like BIO, which is the largest biotechnology industry event in the country. We prepare them and fund them to then go and present at private investor events to help them raise additional capital. And we find that, because we're the NCI, we can help open doors for them that they otherwise wouldn't be able to do. That's one example of a program that we offer. OLIVER: So you really thought about the whole continuing. So if a scientist comes to you with a great idea that has commercial potential, obviously, it has to have commercial potential, they can access all these different resources and services. I wonder if there are early career scientists who are listening to us, and they might be wondering, how can they get into this world that you're supporting? And they're interested in entrepreneurship, they want to apply their science to the patient, ultimately, what are your recommendations and how do you support that community? MICHAEL: So a couple of different mechanisms that we offer, one that I'm particularly excited about is a program called the Small Business Transition grant. This is a program we just launched over the past year. And that program is specifically targeted at post-docs and early career scientists who are still at the university and are working to develop a technology and they're interested in moving that technology out of the lab and potentially to a company. So the way that program is actually set up is post-docs can actually apply for that funding under the Small Business Transition grant. The NCI, they can access up to $2.4 million in funding, just through that one program. The way that program is structured is we call it a Fast Track Award, which means it's a combination of a Phase 1 SBIR and a Phase 2 SBIR. So it's two pieces of funding. The Phase 1 piece is up to $400,000 in funding, and the Phase 2 piece is $2 million in funding. So the way that program works is they collaborate with a small business, they develop their application, they submit it and then it goes through peer review as with other applications. It's really ideally suited for early career scientists. And one of the things we are learning is we actually we need to be more active in communicating with academics about that particular program, because we're not getting as many applications as we would like to see. So we want to do as much as we can to work with that community, and to help them and advise them in applying because we think it's ideally suited for them. Another special thing about that program is it doesn't just provide funding to the post-doc for research, it also provides funding that will support a business mentor and a technical mentor to advise that post-doc. We understand, you know, maybe applying for an SBIR can be somewhat of a daunting prospect, so the funding can help support the needs of the post-doc and through these mentors, specifically. OLIVER: Under this mechanism, the post-doc themselves could transfer into the commercial entity as part of that, is that correct? MICHAEL: Yeah. So I think we try to think of it as a multi-step process. OLIVER: Right. MICHAEL: When they apply for the funding for that first piece of the award, the-- OLIVER: Phase 1-- MICHAEL: --what we call the Phase 1 of the award, they actually will just stay at the university for that first year of the project because we understand, you know, there's going to be some learning and knowledge that they have to gain before they're ready to move to the company. So the Phase 1 will be they will receive it while they're at the university and then as they complete the Phase 1, they're ready to move to the Phase 2 part of the project. At that point, they're supposed to move to the company, and then the funding will go with them to the small business. OLIVER: So what's your advice to early career scientists, maybe even people still undergraduate or in graduate school who are thinking about this as part of their future? What kind of skills could they be getting today even and what kind of exploration could they be doing? MICHAEL: Well, a lot of universities have entrepreneurship programs and almost all of them have technology transfer offices. So if someone is interested, and they've got a bug to be an entrepreneur, most of these universities are going to have classes they can take that will school them in a lot of this. And then there's a lot of hands-on competitions that they can participate in where they might have the opportunity to be teamed with maybe someone from the business school, as an example, to actually develop a business strategy around their technology, so that's probably a really good piece of advice, initially. The other thing I would strongly suggest is, if you have an idea, and you really want to explore SBIR, please contact us. You can go on our website at sbir.cancer.gov and get access to all the different resources we offer and just send us an email and say that you'd like to have a conversation with us and we'll be happy to set up a call where we can learn about you and your interest and give you some advice about SBIR. OLIVER: Thank you, Michael. We'll also put some of those links on the show notes for the podcast and on our podcast webpage. But thank you so much for spending some time with us and telling us about this exciting stuff. MICHAEL: Sure. Thank you for the opportunity. I appreciate it. [UPBEAT MUSIC] OLIVER: PubMed lists over 270,000 cancer papers published in 2022 – that is a staggering 750 papers every day. It's great that cancer research is such an active field, but it makes finding the pubs that are critical to your work a challenge. What if you had an AI that paid attention to the papers you read and suggested others as they appear in PubMed? That is exactly what the NCI is building with an app called NanCI. With me to discuss NanCI are two members of the team that are creating NanCI: Chris Perrien of Blue Pane Studios and Duncan Anderson of Humanise.ai. Chris, you've been building apps for NCI for over a decade. What is new about NanCI? CHRIS PERRIEN: Fundamentally NanCI represents a shift in user experience – in the prior generation of apps people had to know where to look to find things. Now, they can find the information using AI agents. I think of NanCI as a friendly research assistant who makes suggestions and answers questions. Of course, it is early days, and NanCI is still learning from their users, but they will get better and better over time. OLIVER: Duncan, you bring AI expertise to the project. Can you tell us what capabilities that brings to NanCI? DUNCAN ANDERSON: NanCI is all about connecting scientists. Right now the focus is on connecting them to papers relevant to their interests, which NanCI does by matching vector representations of abstracts and looking at co-citations. If you tell NanCI that you find a group of papers interesting, by bookmarking them, the app will keep an eye on PubMed for you and suggest related publications. You can also share these folders with colleagues and export them to your reference manager. You can read the paper right there in NanCI, and follow any author to see when they publish preprints. Down the road we intend to help people network based on shared scientific and career interests. And much more – these are just some of the features of the app. OLIVER: Thanks, Chris and Duncan. Right now NanCI is available in the Apple app store, and it will be coming to android later this year. Download it and give it a try! Your feedback on NanCI is very welcome – you can send that to us here at [email protected]. [UPBEAT MUSIC] OLIVER: And we're back. It's a pleasure to welcome Dr. Margaret Jackson to the podcast. Dr. Jackson is founder and CEO of BYOMass, Inc, a startup company focused on developing novel biologics and small molecules focused on TGF beta and cancer-induced cachexia and anorexia, complicated metabolic syndromes characterized by muscle loss. Welcome. MARGARET JACKSON: Thank you so much for inviting me on. OLIVER: Of course. My pleasure. Dr. Jackson, why did you decide to start BYOMass? MARGARET: You know, I started BYOMass in 2017. And I think it was really a constellation of three different things. One is it's -- I wanted to work on something I'm very passionate about, and anorexia cachexia is something that I know very well because I know the patient, right. My father passed away with cancer. But what was never discussed -- this was when I was about 14. I used to visit him in the hospital. He'd been hospitalized for the last year of his life, and I used to visit him every day. And I was very excited because there's always food waiting for me. And what was never described or discussed was that my dad was -- really wasn't eating. And he was a big farmer, very muscular to then becoming skin and bones after a year of being hospitalized. And we now know that that's a disease in itself and causes over a quarter of deaths within cancer directly. And so, even 30 years later, there's still no treatments. And so I'm at a stage in my career where I can work on what I really, really care about. And that's a really great opportunity for me to work on that area. And then the second is, what would I bring to a startup. You know, I probably wouldn't have been as brave to have started a startup except that, you know, I've had a lot of training. I've been in large pharma for now doing R&D for over 20 years, taking programs from early idea to Phase II clinical studies. So I know how to choose targets. I know how to develop drugs, biologics and small molecules and how to build translatable plans and take them to the clinic. So I'm at a stage in my career where I can combine my passion with what my background training. And then the third is, if you really want to work in that area, you have a choice, then, right, in drug development. You can pursue someone else's idea in large pharma or another startup company in biotech; or you can do your own. And so, hence, I started my own and thought I would try it. And, yes, that was the start of my journey of BYOMass in 2017. OLIVER: So what's the origin of the name of the company? It's spelled capital B capital Y capital O and then Mass. Can you help us understand that? MARGARET: I know. Well, I have to give some credit here now to my husband, Dr. Mike Atlee. And we were brainstorming, like, what would we call the startup? It was a fun activity. But, actually, it's quite hard to choose a name for a company. But because our vision is right, muscle mass, fat mass, and we're based in Massachusetts, we felt mass really had to be in the name. So that's where the mass part come from. And then we're also -- we're a precision medicine company. And we are able to use biomarkers that will stratify patients to enrich them to get more transformative efficacy when we're doing our clinical studies. And so, as part of that, we were like, Okay. Well, it's personalized. And coming from the UK, we have this thing called bring your own bottle, byob. So we thought, why don't we have bring your own mass, which then extended to build your own mass. So that's really the origin of BYOMass. And even today, it still really holds true because we've now learned that we're not just going after prevention and treatment for fat mass, muscle mass. We're also now extending our science into bone mass, liver mass, also tumor mass. So, yes. That's the origin of BYOMass and holds true today. OLIVER: It makes sense. So I understand that BYOMass was a recipient of support from the National Cancer Institute. We spoke to Michael Weingarten before the break about the SBIR program. But what was the nature of support from NCI that BYOMass received? MARGARET: So I actually got two Phase I awards. One was an SBIR. The other was a federal contract, was call for proposals that comes out annually. And one was specifically for anorexia cachexia, so it was really written for BYOMass. That was why we applied for two SBIR grants. And then we -- you know, at that time, I had never actually been in the NIH system. I'm actually from the UK originally. And then with move, with, you know, working in large pharma, I was moved to the US. So I was never really in the NIH academic system. So the process was very new to me. And so it was a steep learning curve, just learning that process. I learned about it through, first of all, through a network here in the Cambridge area in Massachusetts called the Capital Network where they have a session on, like, non-dilutive funding, and brought in people that had been awarded SBIR grants and to inform about how you go about doing these grants. And that was really my reason for reaching out for us to do that. And so then it also was the first time I reached out to a program manager. I -- that time was Patti Weber, and she was excellent. You know, basically, she, you know, made it clear you need to, you know, just describe what your aims are and whether it's a good fit and then apply for the process, which -- which I did, and both were awarded. So that was really the first funding we got within BYOMass that really helped us, you know, get the company off the ground. OLIVER: So you mentioned the program officer or program official. That's the individual working in the SBIR center helping companies understand it. They use another term, non-diluting, I think you referred to. So I think people are familiar with startups looking for money from angel investors, from, you know, venture capitalists and so on. But what is it about the SBIR funding that makes it attractive to a startup? MARGARET: Yeah. I mean, I never heard of the term non-dilutive funding until I went to this capital network event in Cambridge, Massachusetts where they were really, you know, trying to help startups get off the ground because, really, the most expensive money that you ever take is that first VC money, right, because the VC, or angel investor, whether it's seed or series A money, you know, they give you money but at a cost. They take an ownership part, a stake of the company. And so it was the first time I hear this division of non-diluted -- diluted at this network event that I was at. So the value of the non-diluted funding is it's multiple. One, it's a peer-reviewed scientific process, which I think is tremendous. So when you're going out to raise money, you're going out with an idea they've never, ever heard of. Many have never even heard of the indication of cachexia. But the fact that it's been scientifically peer-reviewed and validated by the NIH, then that gives it credibility, number one. Number two is having that Phase I really helps you generate data, which is creating value in your company. So you've now, you know, increased the valuation of your company, if you've achieved milestones, you've now got composition of matter, or you have proof of concept from in vivo studies from an idea that you might have had, that you can then present to a venture capitalist. And then I think the third is the non-dilutive funding, you get it, and it doesn't take any ownership of a company. So you're creating value, increasing the valuation of your company, you know, with a scientifically validated peer-review process that actually allows you to have -- you know, create value and have ownership of that company before going out to raise VC money. And what I'm talking about is the Phase I, but then there's also the -- you can take it even further with the SBIR grant process. By then, once you've got Phase I is really about proof of principle. And if you've validated that proof of principle, get in there and get that Phase II grant as soon as possible because that's a tremendous amount of money for a small startup to get a Phase II award and then, ultimately, Phase IIb. So many companies, if they're very savvy early on in the startup to actually think about a strategy of going for the non-dilutive funding in parallel to trying to raise money because, ultimately, our goal with a CEO is always to raise money and where it comes from. But if you can create value at that early stage to get your molecule to as far as you can without actually having been diluted in your company, that's a really, really great offer for a startup. OLIVER: So, from your perspective, I wonder why do you think that the -- a public funder like the National Cancer Institute is interested in supporting the work of a commercial entity startup like BYOMass? MARGARET: Well, obviously, it's all good for economy overall. But I think, you know, from my experience with the NCI, they're as equally as passionate about anorexia cachexia treatments as what I am. They're well aware that this is a high unmet medical need. There's no approved treatments. And it's not about producing that next paper. It's about getting an actual therapeutic that's going to be beneficial to patients. So, from my experience, I'm sure there's many other reasons. I have no official answer apart from I just know from my experience there's been a lot of passion around anorexia cachexia I've received from NCI. OLIVER: Yeah. I would just -- I would add. I'm a cancer survivor. And during my treatment, there wasn't anything that I received that wasn't ultimately coming through a commercial entity, right? I mean, for something to reach a patient, it needs to go through that model. So that makes great sense. So what would your advice be to our listeners who might be interested in the NCI's SBIR program and might be thinking about applying? MARGARET: Well, I think you should definitely do it. I mean, I -- my whole motto is, you know, you shouldn't be scared to fail. You should always be scared not to try. So you really should, if you're thinking about a startup, if not already have a startup, it's never too early to apply for the SBIR. When I started BYOMass, I had which I felt were two great ideas. We need a lot of preliminary data that's in there. This is really proof of principle. Can you get to, you know, validate, be your target or to get a program up and running to generate molecules, which was one of my programs. And, yeah. And we were awarded. So having that idea with a clear plan of, you know, how you're going to write your aims, what those aims are, we have a couple, and clear deliverables and clear milestones that are achievable in the time period is all you need to start putting down to paper. I think it's also a really good exercise for a startup to really write that out because it's also good when you're having discussions with VCs, etc., that you have a clearly thought-out plan with a budget attached to it and a timeline attached to it. So that itself was a process. Whether you get the grant or not is a really good exercise. I also think that the advice I would give is, you know, when you're thinking about doing these grants, it's not like, oh, my goodness. There's a deadline next week, and I need to apply for it. There is a process. You do need to have a lot of registrations in place. So you really need to be thinking about it about a couple of months before the deadline for the grant and getting those registrations in place. That means getting your company incorporated. It needs to be a company. It needs to be a US company. It needs to have an employee identification number. It needs to have the grants.gov, Small Business Association registration, ERA Commons Association, and that all takes -- and sam.gov. And those all take a little bit of time to get to where you need to give yourself a good six to eight weeks for that is the other advice. I actually had never been through the system. I actually reached out. And I think this is just a -- it's a skill that you need for any startup is, you know, don't be afraid to ask. I did a lot of phone calls to people that I felt would have had these grants to understand the process of how to write those grants. There are also books available you can buy that people that have done this have lived it. And have written books on how to write Phase I, Phase II SBIR grants. You get them on Amazon. I bought those and, you know, takes you step by step of how to write these grants. There are also if you feel that maybe you're not going to be great with doing the submission process, etc., there are companies at the end. These are people that have achieved grants and have now set up their own business to help people submit grants, the administrative process, companies like Free Mind, David Garland Consultancy. They are available to help you. I didn't have much money at the time, and I wasn't going to spend money at that time. But if you had some money, that would be a good use. So I think that would be my guidance. One is reach out to people who've received it. Don't be worried about applying too early, and just get your registrations in place. And reach out to some companies that have actually had this experience, and they may be able to help you with the submission process. OLIVER: Thank you, Dr. Jackson. You've already alluded to this. You've spent some time before you went into the startup world in a large pharma company. I wonder from a -- sort of that perspective of having experienced both what you might say to someone who's listening who's thinking about going into the commercial sector with their science to do science, and maybe they are thinking about a big pharma company or a startup company. What are the differences? MARGARET: Well, first of all, I wouldn't change. I wouldn't change what I've done. I actually felt -- I went -- so just my background is I'm a neuroscience biologist by training, and then I went to large pharma, and that's really what I see as a tremendous training ground. You work with fabulous talented people across different disciplines as first time. You get exposed to working with chemists; you know, BDM; safety; toxicology; clinicians, everybody who are excellent in their own discipline. You get involved in working in project teams, and you learn about your little bit of science but sent to the whole bigger project. And it's not just about trying to think about generating a paper. It's around really making sure it's all validated that you can actually then convert that idea into a preclinical drug development program, that then you build a translatable plan to nominate clinical candidates and then get into the clinic and what you're going to measure in the clinic. So I felt I had a tremendous training ground, and I did that over and over again. I'm taking programs from early idea to Phase II clinical studies with multiple teams across multiple different sites within the company. I was in the UK and in the US. So that was a tremendous experience. And that enabled me to be coming with the confidence and doing a startup that that was what I could bring to a startup was moving those programs along from a great target to a great clinical candidate and development program. I think the downside of that is, you know, usually when you work in large pharma, they're huge organizations. They change every three years. There's never really continuity. There's always changes that are occurring. That brings you another skill, to be adaptable and flexible. But it also means that you're not always focused on one project. You're also competing against multiple other projects, not just within your own therapeutic area, but across multiple therapeutic areas. Also, it can be a large time sink. You have meetings, for meetings, for meetings. I used to spend my whole day with meetings and then the evening to find trying to catch up on the, you know, hundreds of emails that you have to respond to. And it really was never just about that key project, but you're moving things along. So the advantage, then, for a startup is you can be smaller, more nimble, and more faster decision-making. So when the data comes in, you have your core team, and you decide the next step in that meeting. And then things progress. So the pros definitely for a large firm is tremendous talent, and it has the resources to get things done. But, for a startup, you don't really have that hierarchy, that bureaucracy; and decision-making is much, much quicker. OLIVER: So you mentioned you were in neuroscience. I'm always curious. What sparked your initial interest in science? How did you choose to become a scientist? MARGARET: Well, I guess it goes back to my story about my father. I, you know -- I'm probably the first person in my family that actually went to university. You go to school, and then there was the standard jobs thing. There's a long time ago. There's standard jobs that, you know, that you would -- you would either continue to work in like whether your family was working in or you work somewhere local. We didn't really travel. And so it was only whenever -- whenever you have someone that you're visiting everyday in a hospital, you can see that there are lots of other opportunities in that medical space. And I actually thought that I initially would like to, you know, maybe work in the hematology space. So I actually then went to university to do that, but I had a great opportunity when university was the first year that introduced a placement year where you could go out and actually have experience in -- you know, to learn an area of science and actually do the job. And I actually took the opportunity to go to the States, and I actually worked at Reno, Nevada was the first time. Wasn't doing hematology. The role that was given to us was actually electrophysiology and working on the gut nervous system and pacemaker cells, and I absolutely loved it. I just -- that was just for me. And then that experience then helped me then to get a PhD. So it was just a natural progression to move in and to do a PhD in electrophysiology and in neuroscience. I was working in peripheral neuroscience. And then just serendipitously, it typically then I applied for a grant that gave me a Royal Society fellowship when I went to Australia. So I was able to combine travel with actually the science. But the initial trigger for the science really came from, you know, just being able -- being in the hospital every day for a year and seeing other jobs who were there, and that just sort of catapulted me to go to university. OLIVER: So I wonder, then, as you progressed through your career, did you consider academia as a path? MARGARET: Yeah. I think everybody does. It's comfortable. I actually did my PhD at the University of Oxford, which is a fabulous place to be and great resources. And I also postdoc'd there, and then I went to -- went to Australia where I started a fellowship. And it would have been very easy to stay there, and it's comfortable. It was -- it was great. I did see that, you know, there were people who were still postdoc'ing after many, many, many years. It was hard to get funding, hard to get opportunities that time, which was sort of the first negative I really saw in my early academic career. And then the second was -- you know, so I was recording from neurons. I'd write a paper about it, what was it actually doing that was going to change the world. It wasn't -- I didn't see where it fit into the bigger picture. And then that's why I applied. It was many years ago wasn't really the experience of whatever you developed in your lab could be a spin-out for a company was not part of the mantra at that time. It was either you work in academia, or you go to large pharma. And my -- so my reason for going to large pharma was, one, it spelled more, like, job security to go there. And, number two, it was more about, you know, would this actually be able to transform what you were doing as your basic science into potential therapeutic. And at that time, I was just interested in learning how to develop medicines. I wasn't -- it wasn't about a particular disease area at that time that I was interested in. But I was privileged enough that I got to go, and I worked at Pfizer in the UK, which was a great place and got to work in multiple disease areas. And you could see, again, how you -- your little science that you're working on fit into the bigger picture of moving things along. I also had a privilege that I had an idea that I had that actually there was already a molecule that was already sitting on the shelf at Pfizer that I was then able to lead straight away and catapult into a clinical trial without having to do all, you know, the five years build-up of a preclinical program, which helped me really accelerate and see how you're doing clinical trials. And there's nothing more exciting than getting a drug in for the first time into a patient population. That's incredibly exciting. OLIVER: I can imagine. Fantastic. So, you know, we've had guests on the podcast who've just started their own academic research labs. You've started a company. I wonder what your thoughts are. What are the things you're thinking about as you start with a blank piece of paper and you're going to found BYOMass. How do you start that? How do you do that? MARGARET: So, really, it comes down to do you have a good target? Do you have the right modality to go after that target? And then do you have the right patient population to go after? All those steps all fit in with, like, the indication you're going after. So, in case of anorexia cachexia, I knew that I really wanted to work in this space. And you start looking at, well, why have people not been successful in this space? And it's because they didn't really understand the patient. People went in with therapeutics for appetite or went in with therapeutics to increase muscle mass, but they were not the underlying causal mechanism of the actual disease itself. So, within BYOMass, we wanted to understand what was the cancer making that was causing that loss of appetite and that loss of muscle mass. And then the fact that you have something then that is -- that they're making that is then elevated in patients, you can measure from a simple blood biomarker meant then you could stratify patients. And, actually, because this is -- anorexia cachexia, it's such a heterogeneous population. So to recruit trials just because so much body weight has been a failure. You need to have body weight plus if they've got a biomarker that we think is causing that weight loss, and then we can enrich those patients and then go on to understand the modality, how we would go about, you know, being able to block that signal. And then that really comes down to, then, starting the drug development program. So it shouldn't really start from -- it should really start with the patient. It should start with that, you know, what we know is the causal mechanism within the patient, not within a mouse or within a preclinical model but really understanding that causal mechanism. Have you got a biomarker to stratify the patients, and then can you therapeutically target. Then you can work up what your preclinical models are that translate to the patient, not try to translate your preclinical models to fit a patient population. I think that's quite often -- that's often probably a concern, I would say, for many who start from working always living in a lab working with mice, what they find and then trying to translate into patients, that you have to start with a patient and then -- and then build your program from there. OLIVER: That makes complete sense. I guess another parallel between a startup company and a starting research lab is probably the people that you bring into your team, right. So are you recruiting, like, an academic lab? Does -- are you recruiting postdocs, probably you don't have graduate students but postdocs on your team? And how does that look? MARGARET: No, no. Great question. So when you're starting to set up a company, you don't really have a lot of money, right? And you really -- it's called bootstrapping when you're trying to get that initial idea off the ground. And so, in a startup, you know, people would normally think, oh, I'd fill it up with like a lot of C suite level individuals that, you know, will cover everything from finance to legal to operations to science. And you really don't have the money for the talent that you really need. So, at an early stage of a company, like think about seed or even early series A, you don't really need all of those positions full time. And so setting up the company meant that thinking of a different way of being able to access that talent but not having to pay it as a full-time employee rate. So we were able to identify really terrific consultants to cover those roles, that you can then cover by contract or by hourly basis. So you're actually minimizing spend but getting what you need to help the company move along at that stage of your company. From the scientific part, we've set up a -- we didn't bring in PhD postdocs necessarily full time. We started off by having -- at the startup, we actually set up collaborations with academic labs. And I've got some terrific collaborators that can continue even because we started off BYOMass. They've been able to support us to get the work we -- we've done and using their facilities and their university because you -- as a startup, you can't afford necessarily all the facilities that you need to actually deliver what you need in your program. But you certainly can achieve it by having really exceptional PhD and postdocs and then also using their facilities. And then the goal would be that if those individuals would be interested to working full time in BYOMass, that they would move to BYOMass or to a startup company, or they would continue that, just that collaborative relationship. But I feel it has to be a really great collaboration between academia and a startup company and sharing resources and experience. OLIVER: So BYOMass is about six years old; is that right? So, to finish, could you tell us how are things going? MARGARET: It's going good. We've just completed our first IND toxicology study, which was -- looks great. OLIVER: Could you explain that a little bit more, just in case our listeners are not familiar. MARGARET: So BYOMass started off de novo, which meant that we started off building everything internally ourselves. We didn't license in therapeutic molecules. We actually set up screens. We identified our own targets. We set up our screens to identify our – they're molecules, biologics and small molecules. And then we took that from -- the way this drug developed process work is we have called hit identification stage where you've set up all your in vitro or in vivo screens. You start off with the in vitro screens. You make libraries of molecules, therapeutics or small molecules, and you screen against to see if they hit the target. And then you look at selectivity of that. And then you triage those and do a thing called hit expansion, where you would then try and build SAR. And, basically, can you understand that there are relationships association or in the molecules that you are -- that you are making, that informs how they're targeting the target that you're going after. OLIVER: That stands for structure activity relationship, right? MARGARET: That's right. Yes. Exactly. And then the next step, then, is once you've actually got really great hit lead, you start to get a lead optimization. So you have a couple of lead series that you're interested in that you want to optimize further to make them developable as a potential clinical candidate to work for potential clinical studies. That stage typically takes 12 to 18 months to then get clinical candidate. And then, once you get your clinical candidate stage, then you start for a biologic, which was our lead program, which we start manufacturing and toxicology studies, which are part of the IND enabling package required to submit to the FDA to initiate your clinical development program. OLIVER: And IND is? MARGARET: Investigational new drug. OLIVER: Ah. MARGARET: These are documents that are required to submit to the FDA. So we had a very successful pre-IND meeting with the FDA to discuss what we were going to do as part of our safety package and for our manufacturing package. And with that, then we were able to trigger our toxicology package. And so we were able to complete our toxicology safety studies. And we're now ready to enter into Phase I clinical studies. So that's a really great achievement. We start off with the two programs from -- that were funded through the -- through the NIH, the NCI, the SBIR and the federal contract. And fast forward to today, we now actually have five programs from -- originated from those two programs. Just completed our first IND package, right to enter Phase I. So the stage we are, like many startup companies, is raising money. It's all now about raising money and trying to fund, which I consider to be the expensive parts now, which are the clinical development program. OLIVER: Of course. Well, it's fantastic. You made tremendous progress. I wish you nothing but success in the future. Your -- your work is very important, obviously, to cancer patients. So thank you for that. MARGARET: Well, thank you very much for having me online today. And yep. Also, if anybody is interested in reaching out directly, more than happy to help or speak to anybody that is interested in, you know, really starting a startup. OLIVER: Fantastic. Thank you for that. We will put your contact information in the show notes, and maybe some folks will reach out to you. Well, thank you very much, Dr. Jackson, for joining us today on the pod. MARGARET: Sounds great. Thank you. Bye. [UPBEAT MUSIC] OLIVER: Now it's time for a segment we call Your Turn because it's a chance for our listeners to send in their recommendations that they would like to share. If you're listening, then you're invited to take your turn. Send us a tip about a book or a video or podcast or a talk that you found inspirational or amusing or interesting. You can send these to us at [email protected]. Record a voice memo and send it along and we may just play it on an upcoming episode. Now I'd like to invite you Michael, it's your turn. MICHAEL: Oh, thank you, thank you. So I guess in thinking about this, the one thing that I would recommend to folks is go see a movie called "The Whale". I had the opportunity to watch it this past weekend and for me I just felt like that was a movie that really connected with me. It's about a man who is a recluse. His only connection to the outside world is actually through his caregiver and through the person who delivers his food every day to his door. And the only person he actually sees every day is his caretaker. But unfortunately he's obese and he's eating himself to death. OLIVER: Huh. Michael: So obviously that part of the movie, it's very difficult to watch but despite all those challenges, he's still able to have this optimistic outlook on life and he spends the movie trying to reconnect with his daughter that he's been estranged with for a number of years. So the movie follows a lot of scenes where, you know, she's very distant from him when she first comes to visit him. She's kind of disgusted by his appearance but over the course of the movie, those barriers break down and he's able, slowly, slowly, to connect with her and it's just a very heartfelt moving story where you feel a great deal of empathy for his situation. But ultimately he's able to connect with his daughter in the end which really brings the movie home for me. OLIVER: Well thank you, that sounds like a very interesting movie, thank you. And I'd like to make a recommendation as well. So I'm a scientist but I also have other interests. One is history and I recently reread one of my favorite books, a real classic of medieval history. It's called "A Distant Mirror" by Barbara Tuchman. It focuses on the history of the 14th Century, a calamitous period with endless war and recurring plagues and is centered on what is happening in France and England. De Coucy, a noble family with ties to both kingdoms, are at the center of the narrative. It's a substantial book but very well-written and as the title suggests, you will discover that there are so many similarities between the concerns of people 600 years ago and now, which is both heartening and unsettling. [UPBEAT MUSIC] That's all we have time for on today's episode of Inside Cancer Careers! Thank you for joining us and thank you to our guests. We want to hear from you – your stories, your ideas and your feedback are always welcome. And you are invited to take your turn to make a recommendation we can share with our listeners. You can reach us at [email protected]. Inside Cancer Careers is a collaboration between NCI's Office of Communications and Public Liaison and the Center for Cancer Training. It is produced by Angela Jones and Astrid Masfar and Edited by Janette Goeser. A special thanks to Lakshmi Grama and Sabrina Islam-Rahman. Join us every first and third Thursday of the month when new episodes can be found wherever you listen – subscribe so you won't miss an episode. I'm your host Oliver Bogler from the National Cancer Institute and I look forward to sharing your stories here on Inside Cancer Careers. If you have questions about cancer or comments about this podcast, email us at [email protected] or call us at 800-422-6237. And please be sure to mention Inside Cancer Careers in your query. We are a production of the U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening.

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